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Document 52020SC0010

COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL 2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017

SWD/2020/10 final

Brussels, 5.2.2020

SWD(2020) 10 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017



























{COM(2020) 16 final}


Contents

I. INTRODUCTION    

II. DATA SUBMITTED AND GENERAL ASSESSMENT    

II.1. Data Submitted by the Member States    

II.2. General Considerations    

II.2.1 Link to the previous statistical reports under Directive 86/609/EEC    

II.3. Report structure    

SECTION A: COMPILATION AND OVERVIEW OF THE EU DATA BETWEEN 2015 AND 2017    

III.1 Numbers of animals used for research, testing, routine production and educational purposes in the EU    

III.1.1. Numbers of animals used for the first time    

III.1.2. Origin of animals used for the first time    

III.1.2.1. Place of birth of animals (other than non-human primates)    

III.1.2.2. Origin of non-human primates    

III.1.2.2.1. Non-human primates - Source    

III.1.2.2.2. Non-human primates - Generation    

III.2. Details of all uses of animals for research, testing, routine production and educational purposes in the EU    

III.2.1. Overview of the main scientific purposes and the related severities    

III.2.1.1. Main categories of scientific purposes    

III.2.1.2. Severity of uses    

III.2.1.3. Main animal species used by high level purpose categories    

III.2.2. Detailed information on use purposes    

III.2.2.1. Research related uses    

III.2.2.2. Uses of animals for regulatory purposes    

III.2.2.3. Routine production uses    

III.2.2.4. Other types of uses    

III.2.3. Information on reuses and genetic status of animals    

III.2.3.1. Reuses    

III.2.3.2. Use of genetically altered animals    

III.3. Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU    

III.3.1. Numbers of animals used for the creation and maintenance of genetically altered animals    

III.3.2. All uses of animals for the creation of new genetic altered animal lines    

III.3.2.1. Creation of new genetically altered animals lines by genetic status    

III.3.2.2. Creation of new genetically altered animals lines by scientific purposes    

III.3.2.3. Creation of new genetically altered animal lines by severity    

III.3.2.4. Reuses    

III.3.3. All uses of animals for the maintenance of colonies of established genetically altered animal lines    

III.3.3.1. Maintenance of colonies of established genetically altered animal lines by genetic status    

III.3.3.2. Maintenance of colonies of established genetically altered animal lines by severity    

III.3.3.2. Maintenance of colonies of established genetically altered animal lines by species    

III.3.3.3. Reuses    

III.4. Glossary of terms    

 


I. INTRODUCTION

This Commission Staff Working Document accompanies “2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017”, which summarises the data and conclusions presented in this document.

The objective of the report is to present statistical information on the use of animals in procedures in the European Union under Directive 2010/63/EU 1 of 22 September 2010 on the protection of animals used for scientific purposes (“the Directive”). The obligation of the Member States to collect statistical data is covered by Article 54(2) of the Directive.

Regulation (EU) 2019/1010 2 (“the Regulation”) amended Article 54(2) of the Directive. This report is based on data provided by Member States in accordance with the previous wording of Article 54(2) requiring the collection on an annual basis of statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures. The amended Article 54(2) requires Member States to submit the statistical data by electronic transfer in a non-summarised format to the Commission.

As the Regulation was adopted in June 2019, the first annual dataset in line with the new wording of Article 54(2) will be collected in 2020 and is required to be submitted to the Commission by 10 November 2021. That Member State data will then be made available through an open access database in 2022 accompanied by a summary report thereof.

The Regulation also removed the obligation of the Commission to submit a statistical report to the European Parliament and the Council. However, since improved transparency is one of the key objectives of the Directive, the Commission considers it appropriate, as well as necessary in support of the other objectives of the Directive, that the data submitted by the Member States is made available on a yearly basis until 2022.

This first report under Directive 2010/63/EU contains the results of the data collected by all 28 Member States between 2015 and 2017.

II. DATA SUBMITTED AND GENERAL ASSESSMENT

II.1. Data Submitted by the Member States

The data were collected according to the Commission Implementing Decision 2012/707/EU of 14 November 2012 establishing a format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and the Council on the protection of animals used for scientific purposes.

II.2. General Considerations

The Section A of this report aims at providing a comprehensive overview on the use of animals in procedures in the European Union between 2015 and 2017. The purposes of the use of animals have been analysed at EU level, and some of these purposes have been broken down into more precise sub-categories.

In this report, data are presented either in the form of figures or summary tables providing information on a specific aspect of the Directive. Overall numbers are given for the three reported years. However, where the statistics focus on a more detailed breakdown to get a better understanding of the area being analysed (for example breakdown of animal species used for the first time), these are based on data from the year 2017. This decision was taken for two main reasons: the first is that 2017 is the most recent year with a comprehensive dataset, the second is that due to the changed reporting criteria, it is expected that the data from 2017 would be of the highest accuracy. Key findings are presented in the form of tables and graphics. However, in some cases, further information in the text may have been drawn both from annexed tables and Member State narratives (see Section C of this Staff Working Document). Member State narratives have been helpful in providing information such as for the content of ‘other’ categories (for example, ‘other rodents’, ‘other basic research’).

It is important to note in this context that the introduction of new reporting criteria represents a number of challenges. Good data quality requires clear understanding, by all involved, of all new requirements (such as severity reporting), any terms used and data categorization. Furthermore, the way in which the reporting requirements have been implemented at the national level, including any additional support (national guidance, training) play an important role in the data quality.

Some elements of the new reporting have proven extremely demanding, having required extensive efforts by Member States and the Commission. One such example concerns the reporting of animals used for the maintenance of genetically altered animals, and uses that should be covered under this category. Another example concerns the reporting of actual, experienced severity.

The two main issues when reporting actual severity were: confusion between prospective severity classification (for the purposes of a project evaluation) assigned for an entire group of animals versus the actual experienced severity, which is assigned to each animal individually on the basis of observed and recorded adverse effects; and how to incorporate expert judgement in the severity assessment in a consistent manner over time and between establishments, regions and Member States.

To help in this process, some Member States have been particularly active in their efforts to improve data quality. Furthermore, some stakeholder organisations have offered workshops to address issues around severity reporting. With these and other efforts, the statistical data quality is expected to continue to improve. As errors are being detected and consistency improved, it is clear that some of the fluctuations in numbers, or even what may seem to appear as trends at this early stage, may indeed instead be due to improved understanding of the reporting obligations. Finally, for these same reasons it is too early to draw conclusions on any firm trends on the basis of the first three years of data.

II.2.1 Link to the previous statistical reports under Directive 86/609/EEC 3

As there are significant differences from the previous reporting requirements, the data presented in this report are not, in general, comparable with the information presented in reports published under the former Directive 86/609/EEC.

The new reports were developed to provide significantly more detailed and tailored information on animal use. They include aspects of animal use, which have not previously been available, for example, on the genetic status of animals and the actual severity experienced by the animals during their use in procedures. In terms of numbers, some uses of animals, which were previously grouped together, are now covered by different sections of this report. Moreover, the new reports cover areas of animal use that were not included in the reports under the previous legislation.

With this in mind, the only limited comparison which may be attempted concern the numbers of animals used for the first time for the purposes of research and testing 4 . However, even here the comparison is not obvious, because (1) invertebrate species were not included in the past reports and they are now, and (2) the previous numbers included partly those animals that were used for the creation of genetically altered animal lines (which are now separate), leaving the comparison between 2011 and current numbers of animals only as an estimate.

The main differences from previous reports are summarised below:

1.The scope of the Directive and subsequently the related reporting requirements have changed considerably. The new reports include new classes of animals, namely all species of Cephalopods (for example octopus, squid and cuttlefish). In addition, the maintenance (breeding) of certain types of genetically altered animals is covered. Neither of these categories was included in previous reports.

2.The time of reporting. The data published previously reported the numbers of animals at the start of their use (“procedure”). However, Directive 2010/63/EU requires that information is reported on the actual impact on the welfare of the animals used for scientific purposes. For this reason, in contrast to previous reporting, the information is submitted when a use of an animal is complete. Therefore, the data under Directive 2010/63/EU are reported at the end of the procedure.

3.Each use of an animal is counted. The data captured by the new reporting criteria include both the numbers of uses of new animals (not previously used in a procedure) and "reuses" (animals that have already previously been used in a procedure). “Uses” therefore includes both the “first use” and all subsequent “reuses”.    

Furthermore, previously, the details were reported only from the first use and therefore, no information was captured on any subsequent uses. Although the majority of animals are used only once, the Directive provides for a possibility to reuse animals under certain conditions (Article 16 of the Directive). Reuse can reduce the overall number of animals, where this does not detract from the scientific objective or cause significant welfare compromise. However, the benefit of re-using animals (a reduction in numbers) needs to be carefully balanced against any adverse effects on their welfare, taking into account the lifetime experience of each individual animal. Reuse must be considered on a case-by-case basis (recital 25 of the Directive).

4.The actual severity experienced by an animal during a procedure is one of the key innovations of the new report. The severities are categorised as “non-recovery”, “mild”, “moderate” or “severe”. “Non-recovery” means that the animal has undergone a procedure that has been performed entirely under a general anaesthesia and from which the animal has not recovered. This includes also the situation where the animal has failed to recover consciousness from anaesthesia during the first step of a planned recovery procedure.

The following table presents the differences between the reporting requirements of the two Directives:

Reporting

Former Directive (86/609/EEC)

Current Directive (2010/63/EU)

Scope – species

Only vertebrate species

Vertebrate species and Cephalopods

Scope – purpose

No reporting of breeding of genetically altered animals

Maintenance (breeding) of genetically altered (GA) animals with intended harmful phenotype (characteristic/trait) and which have experienced suffering

First use and reuse

(animals used versus uses of animals)

Number of new animals, and only the number of reuses of the species covered by the Annex I of Directive 86/609/EEC with no related details of the reuse

Number of new animals, and in addition all reuses. All uses reported with full datasets

Source of Non-human primates (NHPs)

Information on European origins but not from other geographical regions

More detailed information on where NHPs have been obtained, in particular outside Europe

Generation of NHP breeding

Not reported

Information on progress from wild caught (F0), to first generation purpose-bred (F1), second generation purpose-bred animals (F2), to self-sustaining colonies.

Genetic Status

Not reported

·No genetic alteration (GA)

·GA with a non-harmful phenotype

·GA with a harmful phenotype

Purposes

Broad headings

More detailed information of previously reported categories with further sub-categorisation, such as for ecotoxicity, routine production and GA maintenance

Creation of a new genetically altered (GA) line

Not reported

Creation of a new GA line together with the intended purpose

Actual severity

Not reported

Actual severity reported under four categories

·Non-recovery

·Mild

·Moderate

·Severe

II.3. Report structure

For the first time at the level of the EU, the statistical information is collected, not only on the scientific uses of animals for the purposes of research and testing, but also on the scientific uses for the creation and maintenance of genetically altered animal lines in support of research needs. Equally, it is the first time that full datasets are available for each use of an animal, allowing for a much more precise reporting.

It is therefore the objective of this report to present all these data structured in a manner that allows for an improved understanding of when and how animals are still used in science today. It is hoped that, in line with the Directive aims, this way of reporting will better facilitate the identification of animal use areas on which efforts for the development and validation of alternative approaches can be focused.

First uses

Creation and maintenance of genetically altered animals

*) research, testing, routine production and education (including in training)

Part 1

Numbers of animals

used in research and testing*)

Part 2

All uses of animals

in research and testing*)

Reuses

Genetically altered animals

Part 3

Numbers and uses of animals

for the provision of genetically altered animals

Therefore, Section A of the report is composed of three parts as illustrated in the picture below:

Numbers of animals used for research, testing, routine production and educational purposes 5 in the EU – Part 1 (III.1)

The first part focuses on the numbers of animals used, for the first time, for the purposes of research, testing, routine production and education (term ‘education’ in the context of this report also includes animals used for the purposes of training). These animals can be both conventional animals or those that have been genetically altered. This part reports on their numbers and origins. It excludes animals that have been used for the creation of a new genetically altered animal line, or maintenance of an existing genetically altered animal line. These are covered in part three below.

Details of all uses of animals for research, testing, routine production and educational purposes in the EU – Part 2 (III.2)

The second part focuses on the way in which animals are used in these scientific procedures, covering all uses, both the first and any subsequent reuse. This serves to draw an overall picture of all uses of animals for the purposes of research, testing, routine production and education in the EU. This part takes into account the nature of the procedures, their legislative context, reuse of animals, the genetic status of the animals, and the severities experienced by the animals.

Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU – Part 3 (III.3)

The third part focuses on the provision of genetically altered animals needed to support scientific research in the Union. It reports, on one hand, on animals used in procedures for the creation of new genetically altered animal lines and, on the other, the maintenance of colonies of existing genetically altered animals. Like in part one of this report, it provides the actual numbers of animals, used for the first time, as well as more detailed information taking into account all uses (first, and any subsequent reuse) for the purposes of creation and maintenance of genetically altered animal lines. It also provides further information on the type of research for which new genetically altered animal lines are being created. These animals have not been used in other scientific procedures, in other words the data are separate from those covered in parts one and two of this report.

Section B of this report contains EU level data that have been used as the basis for conclusions in Section A of the report. Section C of this report provides data from the Member States together with their respective narratives.

Information outside of the scope of the statistical report

What remains outside of the scope of annual statistical reporting – even if covered by the scope and provisions of the Directive, are:

·Foetal forms of mammals;

·Animals killed solely for organs and tissues, and sentinels, unless the killing is performed under a project authorisation using a method not included in Annex IV of Directive 2010/63/EU;

·Animals bred and killed without being used, apart from genetically altered animals with intended and exhibited harmful phenotype, and those having been genotyped with an invasive method before being killed.

Additional information on animals bred and killed without being used will be reported in the five-year report on the implementation of the Directive in line with Article 54(1) of the Directive.

SECTION A: COMPILATION AND OVERVIEW OF THE EU DATA BETWEEN 2015 AND 2017

III.1 Numbers of animals used for research, testing, routine production and educational purposes in the EU

This part focuses on the numbers of animals used for the first time in procedures for the purposes of research, testing, routine production and education. Therefore, it excludes all reuses of animals that are considered in the second part. It also excludes animals that are used either for the creation of new genetic altered lines or the maintenance of colonies of established genetically altered animal lines. However, animals used for research, testing, routine production and educational purposes can be conventional or genetically altered.

In addition to the numbers of animals, this part also provides information on the species in relation to their origin, and for non-human primates, information on progress to purpose-bred animals, by recording generation.

III.1.1. Numbers of animals used for the first time

Between 2015 and 2017, the number of animals used for the first time in the EU annually is below 10 million. The total number of animals decreased slightly from 9.59 million in 2015 to 9.39 million in 2017 (-2%). However, there was a small increase to 9.82 million in 2016, preventing the identification of a clear trend (Table 1.1).

2015

2016

2017

Total

9,590,379

9,817,946

9,388,162

Table 1.1: Total numbers of animals used for the first time for research, testing, routine production and education purposes in the EU between 2015 and 2017

In 2017, the main species used for the first time for research, testing, routine production and educational purposes were mice, fish, rats and birds that together represented 92% of the total number of animals. Species of particular public concern (dogs, cats and non-human primates (NHP)) represented less than 0.3% of the total number of animals. No great apes are used for scientific purposes in the European Union (Figure 1.1).

Figure 1.1: Numbers of animals used for the first time by main classes of species in 2017

Looking at this higher level of grouping from 2015 to 2017 (table 1.2), the number of birds decreased
(-11%) as well as the number of amphibians, cephalopods, reptiles (together) (-42%) due to a significant drop in cephalopods in 2016. However, the actual number of cephalopods remains low (15,862 in 2015 to 514 in 2017 - Table 1.4). As a general remark, it is important to note that numbers can fluctuate year to year, particularly so with fish, amphibian and cephalopods where studies on immature forms may involve large numbers (thousands) of animals.

2015

2016

2017

Mice

5,711,612

5,989,413

5,707,471

Rats

1,201,189

1,173,135

1,146,299

Other mammals

713,113

700,262

719,576

Fish

1,275,067

1,304,737

1,219,695

Birds

635,211

595,724

563,963

Amphibians, Cephalopods, Reptiles

54,187

54,675

31,158

Total

9,590,379

9,817,946

9,388,162

Table 1.2: Numbers of animals used for the first time by main classes of species

For fish, the Directive distinguishes zebra fish (41% of fish in 2017) from other fish species. The main "other" fish species (719,932 in 2017 - Table 1.4) reported during the period (2015-2017) were seabass, guppies, trout and salmon.

For birds, the Directive distinguishes domestic fowls (82% of birds in 2017) from other birds. The main species reported as “Other birds” (99,410 in 2017 – Table 1.4) were turkey and the Great Tit (Parus major).

For amphibians, the Directive distinguishes rana (13% of amphibians in 2017) and xenopus (49% of amphibians in 2017) from other amphibians. The main species reported as “Other amphibians” (10,683 – Table 1.4) during the period was bufo (toads).

First uses of mammals between 2015 and 2017 are reported in more detail in table 1.3 below.

2015

2016

2017

Mice

5,711,612

5,989,413

5,707,471

Rats

1,201,189

1,173,135

1,146,299

Guinea-Pigs

149,328

150,985

144,824

Other rodents

52,512

38,490

43,298

Rabbits

346,052

350,405

351,961

Cats

1,975

1,951

1,879

Dogs

14,501

15,691

13,688

Other carnivores

5,860

2,974

4,402

Farm animals

126,214

128,890

124,954

Non-human primates

7,136

7,239

8,235

Other mammals

9,535

3,637

26,335

Total

7,625,914

7,862,810

7,573,346

Table 1.3: Numbers of animals used for the first time in the Mammal category

Farm animals include horses, donkeys and cross-breeds, pigs, goats, sheep and cattle. "Other carnivores" (4,402 in 2017) reported were ferrets, mink and badgers while "Other rodents" (43,298) were hamsters and wild species of rodents and "Other mammals" mainly bats.

Between 2015 and 2017, the numbers of farm animals remained stable. There was an increase (+14%) in cattle use, while remaining farm animals saw a decrease (-25% for horses, donkeys and cross breed).

The numbers of “Other carnivores” showed some fluctuation but no obvious reason could be identified from the statistics.

Numbers of “Other mammals” increased significantly between 2015 and 2017 due to a high number of bats in 2017 used in procedures to study human infectious disorders.

The species of non-human primates reported during the period were: prosimians, marmoset and tamarins, squirrel monkey, other species of new world monkey (ceboidea), cynomolgus monkey, rhesus monkey, vervets chlorocebus, baboons, and other species of old world monkeys (cercopithecoidea). In line with the general ban on the use of great apes, introduced by the Directive, no such use was reported during that period.

Between 2015 and 2017, the numbers of non-human primates saw an increase (+15%). The cynomolgus monkey (representing 88% of non-human primates in 2017 – Table 1.4) was the most commonly used species of non-human primates and had a 16% increase between 2015 and 2017. Numbers of marmosets, rhesus monkeys and other old world monkeys (mainly macaca nemestrina and macaca silenus) also increased slightly. Numbers of other non-human primate species decreased between 2015-2017.

2015

2016

2017

Mice

5,711,612

5,989,413

5,707,471

Rats

1,201,189

1,173,135

1,146,299

Guinea-Pigs

149,328

150,985

144,824

Hamsters (Syrian)

20,195

18,614

12,700

Hamsters (Chinese)

30

519

187

Mongolian gerbil

6,199

5,645

5,239

Other rodents

26,088

13,712

25,172

Rabbits

346,052

350,405

351,961

Cats

1,975

1,951

1,879

Dogs

14,501

15,691

13,688

Ferrets

2,212

1,530

2,016

Other carnivores

3,648

1,444

2,386

Horses, donkeys and cross-breeds

3,217

3,474

2,414

Pigs

73,895

80,029

71,522

Goats

2,233

1,365

1,563

Sheep

20,106

21,240

18,812

Cattle

26,763

22,782

30,643

Prosimians

169

44

98

Marmoset and tamarins

429

285

465

Squirrel monkey

13

8

8

Other species of New World Monkeys (Ceboidea)

0

0

3

Cynomolgus monkey

6,221

6,503

7,227

Rhesus monkey

211

318

353

Vervets (Chlorocebus spp.)

56

19

33

Baboons

37

62

25

Other species of Old World Monkeys (Cercopithecoidea)

0

0

23

Other mammals

9,535

3,637

26,335

Domestic fowl

515,834

500,920

464,553

Other birds

119,377

94,804

99,410

Reptiles

2,414

3,240

2,937

Rana

4,884

4,482

3,485

Xenopus

10,837

18,511

13,539

Other amphibians

20,190

19,558

10,683

Zebra fish

338,815

513,011

499,763

Other Fish

936,252

791,726

719,932

Cephalopods

15,862

8,884

514

Total

9,590,379

9,817,946

9,388,162

Table 1.4: Numbers of animals used for the first time by species

III.1.2. Origin of animals used for the first time

The origin (place of birth) of animals is divided into two categories depending on whether the species belongs to the category of non-human primates or not. For non-human primates, more detailed information is collected on their origin (continent of origin) and in addition their generation is reported (see Part III.1.2.2.).

III.1.2.1. Place of birth of animals (other than non-human primates)

In 2017, almost 90% of the animals used for scientific purposes for the first time were born in the EU at registered breeders and less than 2% were born outside of the EU (either in the rest of Europe or outside of Europe). Category 'animals born in the EU but not at a registered breeder' includes animals from, for example, farms, and studies carried out using wild animals (Figure 1.2).

Figure 1.2: Place of birth of animals other than non-human primates in 2017

Between 2015 and 2017, animals born in the EU but not at a registered breeder decreased slightly
(-20%) and animals born in the rest of the world increased (+61%) partly due to a significant import of bats (18,000).

2015

2016

2017

Animals born in the EU at a registered breeder

88% (8,466,666)

90% (8,874,852)

90% (8,437,271)

Animals born in the EU but not at a registered breeder

10% (955,563)

8% (773,612)

8% (762,288)

Animals born in rest of Europe

1% (94,219)

1% (82,219)

1% (72,952)

Animals born in rest of world

1% (66,795)

1% (80,024)

1% (107,416)

Total

100% (9,583,243)

100% (9,810,707)

100% (9,379,927)

Table 1.5: Place of birth of animals other than non-human primates

Annex I of the Directive contains a list of animals that may only be used where those animals have been bred for use in procedures (see Article 10). Figure 1.3 shows all the animal species listed in Annex I, except non-human primates.

In 2017, amongst the species listed in Annex I, rodents, rabbits and zebra fish were, for the vast majority, born at EU registered breeders (Figure 1.3). Dogs (32%), cats (44%) and to a lesser extent frogs (10%) had a higher proportion of animals born in the EU but at a non-registered breeder (Section B – Table 2). The most common reason for using dogs and cats that came from non-registered breeders in the EU were procedures in pet dogs and cats, which had blood samples taken for studies of genetic disorders, or pet animals, which were involved in patient studies for better treatment methods.

Last, 33% of dogs, 19% of frogs, 9% of hamsters (Syrian) and 8% of cats were imported from the rest of the world, with a significant decrease for cats (-60%) between 2015-2017 (Section B – Table 2).

Figure 1.3: Place of birth of animals other than non-human primates listed in Annex I in 2017

III.1.2.2. Origin of non-human primates

The Directive provides additional protection for non-human primates due to their genetic proximity to human beings, their highly developed social skills and capacity to experience pain, suffering and distress. Furthermore, the Directive recognises that the capture of non-human primates from the wild is highly stressful for the animals concerned and carries an elevated risk of injury and suffering during capture and transport. In order to end the capture of animals from the wild including for the purposes of breeding, the Directive introduced provisions with the objective of moving towards using non-human primates that have been bred, ultimately, in self-sustaining colonies, from parents who themselves have been bred in captivity (see Article 10 of the Directive).

In order to monitor progress, more detailed information is collected on both the origin and generation of non-human primates used in scientific procedures in the EU.

III.1.2.2.1. Non-human primates - Source

In 2017, the three main sources of non-human primates were Africa, Asia and EU registered breeders representing more than 97% of non-human primates used for scientific purposes (Figure 1.4).

Figure 1.4: Source of non-human primates in 2017

In 2017, cynomolgus monkeys represented 88% of non-human primates used for the first time. These were sourced almost entirely from outside of the EU (Table 1.6). In contrast, other species of non-human primates were mainly sourced from EU registered breeders.

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Prosimians

100% (98)

0% (0)

0% (0)

0% (0)

0% (0)

0% (0)

100% (98)

Marmoset and tamarins

81% (377)

0% (0)

0% (0)

0% (0)

9% (42)

10% (46)

100% (465)

Squirrel monkey

62% (5)

0% (0)

0% (0)

25% (2)

0% (0)

12% (1)

100% (8)

Other species of New World Monkeys (Ceboidea)

100% (3)

0% (0)

0% (0)

0% (0)

0% (0)

0% (0)

100% (3)

Cynomolgus monkey

3% (218)

<1% (5)

36% (2,591)

0% (0)

59% (4,290)

2% (123)

100% (7,227)

Rhesus monkey

90% (317)

0% (0)

4% (14)

5% (19)

1% (3)

0% (0)

100% (353)

Vervets (Chlorocebus spp.)

0% (0)

0% (0)

0% (0)

100% (33)

0% (0)

0% (0)

100% (33)

Baboons

100% (25)

0% (0)

0% (0)

0% (0)

0% (0)

0% (0)

100% (25)

Other species of Old World Monkeys (Cercopithecoidea)

61% (14)

0% (0)

39% (9)

0% (0)

0% (0)

0% (0)

100% (23)

Total

13%

(1,057)

0%

(5)

32%

(2,614)

1%

(54)

53%

(4,335)

2%

(170)

100%

(8,235)

Table 1.6: Source of non-human primates by species in 2017

III.1.2.2.2. Non-human primates - Generation

With regard to the generation of non-human primates being bred in captivity in 2017, the majority of non-human primates were sourced either from self-sustaining colonies (30%) or as second or higher generation purpose-bred (53%). No non-human primates were sourced from the wild (Table 1.7) in 2017.

Between 2015 and 2017, non-human primates coming from self-sustaining colonies decreased slightly (-9%). In line with the Directive objectives, those being second or higher generation purpose-bred increased significantly (+67%) and those being of first generation purpose-bred decreased (-23%).

2015

2016

2017

Self-sustaining colony

39% (2,748)

31% (2,271)

30% (2,504)

F2 or greater

37% (2,614)

47% (3,435)

53% (4,368)

F1

25% (1,773)

21% (1,528)

17% (1,363)

F0

0% (1)

0% (5)

0% (0)

Total

100% (7,136)

100% (7,239)

100% (8,235)

Table 1.7: Generation of non-human primates in 2017

Looking at non-human primate species and their generation:

Figure 1.5: Generation of non-human primates by species in 2017

For non-human primates born at a registered breeder in the EU, only 3% of non-human primates used for the first time were from the first generation, in Africa first generation of animals represented 26% in 2017 and first generation non-human primates from elsewhere represented 47% (Table 1.8).

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

F1

3% (32)

0% (0)

3% (88)

30% (16)

26% (1,147)

47% (80)

F2 or greater

40% (418)

100% (5)

75% (1,948)

70% (38)

44% (1,915)

26% (44)

Self-sustaining colony

57% (607)

0% (0)

22% (578)

0% (0)

29% (1,273)

27% (46)

Total

100%

(1,057)

100%

(5)

100%

(2,614)

100%

(54)

100%

(4,335)

100%

(170)

Table 1.8: Generation of non-human primates by source in 2017


III.2. Details of all uses of animals for research, testing, routine production and educational purposes in the EU

This part focuses on all uses of animals for the purposes of research, testing, routine production and education, including the first and any subsequent reuse. It provides detailed information on the reason for use (for example the specific research area, or type of testing) as well as additional information related to the actual severity experienced by the animals, their genetic status and reuse. In addition, information on the use of animals to satisfy legislative requirements is collected.

III.2.1. Overview of the main scientific purposes and the related severities

Between 2015 and 2017, the total number of all uses (first use and any subsequent reuse) for the purposes of research, testing, routine production and education decreased from 9.78 million in 2015 to 9.58 million uses in 2017 (-2%). However, an increase to 10.03 million in 2016 prevents drawing of firm conclusion with regard to a trend in the number of uses (Table 2.1).

2015

2016

2017

Total

9,782,570

10,028,498

9,581,741

Table 2.1: Total number of uses of animals between 2015 and 2017

III.2.1.1. Main categories of scientific purposes

In 2017, 9.58 million uses of animals for scientific purposes were reported by Member States in the European Union.

Most uses were conducted for research purposes (68%) with 45% of the uses being carried out for basic research and 23% for translational and applied research purposes. A further 23% of animal uses in procedures were carried out for regulatory use to satisfy legislative requirements, followed by routine production (5%).

Other categories (4%) include the protection of the natural environment in the interest of the health or welfare of human beings or animals, the preservation of species, the higher education or training for the acquisition, maintenance or improvement or vocational skills and the forensic enquiries (Figure 2.1).

Figure 2.1: Uses of animals used for scientific purpose in 2017

Throughout the entire reporting period (between 2015 and 2017), no clear trend can be identified as the variability across purposes is more significant than the yearly changes. Variations in the "protection of the natural environment in the interests of health or welfare of human being and animals" (+19%) and "preservation of species" (+107%) are related to procedures involving fish larvae (Table 2.2).

2015

2016

2017

Basic research

4,513,820

4,828,533

4,357,653

Translational and applied research

2,151,261

2,214,034

2,199,956

Regulatory use

2,356,352

2,214,832

2,186,859

Routine production

455,494

455,434

469,358

Higher education or training for the acquisition, maintenance or improvement of vocational skills

162,424

164,495

163,762

Protection of the natural environment in the interests of the health or welfare of human beings or animals

104,834

78,403

124,787

Preservation of species

38,070

71,852

78,893

Forensic enquiries

315

915

473

Total

9,782,570

10,028,498

9,581,741

Table 2.2: Uses of animals by main scientific purposes

III.2.1.2. Severity of uses

Directive 2010/63/EU requires the reporting of the actual severity experienced by the animal when used for scientific purposes. In 2017, just over half, 51% of uses, were reported as ‘mild’ (up to and including), 32% as ‘moderate’, and 11% as ‘severe’. 6% of uses were reported as ‘non-recovery’.

The number of uses reported as severe increased proportionally between 2015 and 2016 (Table 2.3). Almost 35% of this increase can be attributed to an increase in the severe uses for the diagnosis of diseases (85,000). The proportion of severe uses remained the same between 2016 and 2017.

It is important to note that the reporting of actual severities is probably the most challenging element of the Directive to achieve consistent reporting within and between Member States as well as over time. Therefore, any firm conclusions on the results of these early years of reporting should be discouraged.

Furthermore, since the actual severities are linked to the type of uses, and the use patterns vary between Member States, it is not advisable to compare overall actual severities between Member States. As an example, a Member State with high proportion of animal use for the purposes of regulatory testing is likely to have higher proportion of severe uses compared to another Member State having mainly uses in the areas of routine production or education and training.

2015

2016

2017

Non-recovery

6% (622,034)

6% (620,848)

6% (621,054)

Mild [up to and including]

54% (5,330,549)

52% (5,239,321)

51% (4,865,721)

Moderate

31% (3,010,980)

31% (3,101,054)

32% (3,071,828)

Severe

8% (819,007)

11% (1,067,275)

11% (1,023,138)

Total

100% (9,782,570)

100% (10,028,498)

100% (9,581,741)

Table 2.3: Severity of uses

In 2017, when looking at high level purposes, most of the uses reported as severe were conducted for regulatory purposes (16% of regulatory uses), while routine production were mostly mild. Uses in translational and applied research tended to be more severe than those reported in basic research (Figure 2.2).

Figure 2.2: Uses of animals by severity and main categories of scientific purposes in 2017

When analysing all the sub-categories of purposes, batch potency testing resulted in the highest number of severe uses (over 264K uses - Figure 2.6), followed by studies on nervous system (over 87K uses - Figure 2.4) and diagnosis of diseases (over 81K uses - Figure 2.5).

When analysing the proportion of severe uses within a sub-category: the production of monoclonal antibodies was the highest (70% of all uses for the production of monoclonal antibodies were severe – Figure 2.10), followed by diagnosis of diseases (54% - Figure 2.5) and acute toxicity studies in the area of ecotoxicity (37% - Figure 2.7).

Taking into account sub-categories with more than 30,000 uses, the lowest severities (severe uses below 1% of all uses within the sub-category) can be found in production of blood based products (0.1% of 260,000 uses – Figure 2.10), followed by preservation of species (0.5% of 79,000 uses – Figure 2.11), education and training (0.5% of 164,000 uses – Figure 2.11) and toxicity testing for skin sensitisation (0.7% of 47,000 uses – Figure 2.7)

III.2.1.3. Main animal species used by high level purpose categories

In 2017, the main species used in basic research were mice (70%), zebra fish (8%), other fish (8%), rats (7%) and domestic fowl (3%). Similar species feature for applied and translational research with proportionally similar uses of mice (70%) and rat (11%). For regulatory use, the distribution changes again slightly with mice covering now only less than half (48%), followed by rat (26%), domestic fowl (7%), other fish (6%) and rabbits (4%). Routine production has a relatively different pattern compared with the other purpose groups, with rabbits accounting for half (50%), followed by domestic fowl (22%), mice (11%) and sheep (10%).

When looking at different groups of species and the likely purposes they will be used for, fish, mice, amphibians, cephalopods, reptiles and rodents are most likely to be used in basic research. Other mammals (bats), other carnivores are most likely to be used for the purposes of applied and translational research. Rabbits, farmed species and birds are mostly used in routine production and finally guinea-pigs, non-human primates and rats for regulatory purposes (Figure 2.3).

Figure 2.3: Uses of animals grouped by main classes of species and the main scientific purpose categories in 2017

Looking at the details of the uses of non-human primates, 65 % are to satisfy legislative requirements for medicinal products for human use (of these 64% are on studies for repeated dose toxicity and 19% for kinetics). In the areas of basic and applied research, non-human primates are mainly used for studying human infectious disorders (7% of all non-human primate uses), nervous system (3%) and non-regulatory toxicology and ecotoxicology (3%). Routine production, of mostly blood based products, represents 10% of non-human primate uses. Some uses of non-human primates were reported for the purposes of education and training, prohibited under the Directive. However, this may have taken place within the transitional provisions under Article 64 of the Directive, allowed until 31.12.2017. The actual reported severities of uses of non-human primates are lower than the EU averages for all species. In 2017, 54% were of mild severity. Only 1,6% of uses were assessed as severe.

III.2.2. Detailed information on use purposes

III.2.2.1. Research related uses

Research-related uses are split between basic research on one side and translational and applied research on the other. Results on these purpose categories are presented with information on related reported actual severities.

III.2.2.1.1 Basic research

Basic research was the main area for which animals were used with more than 4.3 million uses in 2017.

The four main domains of basic research using most animals are nervous system, immune system, oncology and ethology/animal behaviour/animal biology that all together account for more than half of the uses in basic research (Figure 2.4).

Figure 2.4: Basic research related uses by type of research and severity in 2017

In 2017 compared to 2015, there was an increase in the number of uses of animals for oncology (+19%) and nervous system studies (+13%).

During the same period, the sub-categories gastrointestinal system including liver (-38%), urogenital / reproductive system (-31%), ethology/animal behaviour/animal biology (-25%) and immune system (-7%) saw some regular decreases in terms of uses of animals (Table 2.4).

In 2017, in the area of basic research, proportionally highest severities were reported in following sub-categories: immune system (10%), endocrine system/metabolism (9%), oncology (9%), nervous system (9%) and respiratory system (9%).

Proportionally lowest severities were reported for urogenital/reproductive system, ethology/
animal behavior/animal biology, sensory organs and multisystemic (Figure 2.4).

“Other basic research” includes for example research on nutrition, infectious diseases or embryology.

2015

2016

2017

Nervous System

857,813

940,453

969,275

Immune System

804,352

753,296

746,907

Oncology

516,404

572,117

612,344

Ethology / Animal Behaviour /Animal Biology

605,239

564,042

455,475

Other basic research

274,083

414,466

376,584

Cardiovascular Blood and Lymphatic System

338,606

351,636

311,676

Multisystemic

297,605

423,227

215,262

Endocrine System/Metabolism

209,128

301,727

215,212

Gastrointestinal System including Liver

208,033

153,751

129,593

Urogenital/Reproductive System

137,957

112,294

95,475

Musculoskeletal System

92,670

93,387

90,403

Respiratory System

85,778

75,577

73,946

Sensory Organs (skin, eyes and ears)

86,152

72,560

65,501

Total

4,513,820

4,828,533

4,357,653

Table 2.4: Basic research related uses by type of research

III.2.2.1.2. Translational and applied research

Translational and applied research accounted for about 2.2 million uses of animals in 2017.

The four main areas of translational and applied research were human cancer, human nervous and mental disorders, human infectious disorders and animal diseases and disorders.

In 2017, in the area of translational and applied research, proportionally highest severities were reported in following sub-categories: diagnosis of diseases (54%), animal diseases disorders (24%), human immune disorders (22%), human musculoskeletal disorders (16%) and other human disorders (15%).

Proportionally lowest severities were reported for plant diseases, human sensory organs and non-regulatory toxicology and ecotoxicology (Figure 2.5).

Figure 2.5: Translational and applied research related uses by type of research and severity in 2017

Between 2015 and 2017, the sub-categories diagnosis of disease (+76%) and human gastrointestinal disorders including liver (+50%) saw a significant increase. Animal uses for non-regulatory toxicology and ecotoxicology (+20%) as well as human cancer (+19%) showed also an increase.

Sub-categories animal welfare (-20%), human endocrine/metabolism disorders (-18%) and human nervous and mental disorders (-12%) decreased over the same period (Table 2.5).

2015

2016

2017

Human Cancer

492,320

538,261

584,601

Human Nervous and Mental Disorders

345,899

307,087

305,782

Human Infectious Disorders

282,202

283,098

271,847

Animal Diseases and Disorders

223,813

259,986

216,721

Diagnosis of diseases

84,963

170,738

149,687

Human Endocrine/Metabolism Disorders

123,813

107,704

100,663

Non-regulatory toxicology and ecotoxicology

79,911

87,350

96,160

Human Immune Disorders

77,250

71,555

75,342

Human Cardiovascular Disorders

62,163

64,505

69,606

Human Respiratory Disorders

66,384

65,857

67,395

Animal Welfare

78,515

73,754

62,367

Human Sensory Organ Disorders (skin, eyes and ears)

46,386

52,977

52,841

Human Gastrointestinal Disorders including Liver

32,210

43,687

48,630

Other Human Disorders

105,773

38,528

42,654

Human Musculoskeletal Disorders

31,274

36,142

38,315

Human Urogenital/Reproductive Disorders

17,905

12,679

17,169

Plant diseases

480

126

176

Total

2,151,261

2,214,034

2,199,956

Table 2.5: Translational and applied research related uses by type of research

“Other Human Disorders” includes areas such as haemophilia, pharmacokinetics or pain disorders.

III.2.2.2. Uses of animals for regulatory purposes

Regulatory uses cover the use of animals in procedures with a view to satisfying regulatory requirements, that is to say for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed. It also includes tests carried out on products/substances for which a regulatory submission was foreseen but ultimately not made, for instance because these were deemed unsuitable for the market by the developer and thus failed to reach the end of the development process.

Between 2015 and 2017, the total number of uses for regulatory purposes decreased (-7%).

In 2017, regulatory uses accounted for 2.18 million uses, just below translational and applied research. 52% of these uses were related to quality control (including batch safety and potency testing), 39% related to toxicity and other safety testing including pharmacology and the remainder (9%) were for other efficacy and tolerance testing (Table 2.6).

2015

2016

2017

Quality control (incl batch safety and potency testing)

1,332,536

1,218,170

1,131,580

Toxicity and other safety testing including pharmacology

873,587

831,683

843,375

Other efficacy and tolerance testing

150,229

164,979

211,904

Total

2,356,352

2,214,832

2,186,859

Table 2.6: Regulatory uses by main types of uses

III.2.2.2.1. Details of the regulatory use purposes

Quality control includes uses of animals in the testing of purity, stability, efficacy, potency and other quality control parameters product (and its constituents) such as vaccines, and any controls carried out during the manufacturing process for registration purposes, to satisfy any other national or international regulatory requirements or to satisfy the in-house policy of the manufacturer.

Quality control related uses represented 1.1 million uses in 2017. A large majority of these uses were related to batch potency-testing purposes (79%).

With more than 261,000 severe uses, batch potency testing was the most severe type of procedure, representing more than 25% of all severe uses in EU (Figure 2.6).

Figure 2.6: Quality control related uses by type of use and severity in 2017

Overall, quality control related uses decreased between 2015 and 2017 (-15%) with a decrease for batch safety testing (-39%), for batch potency testing (-14%) and for pyrogenicity testing (-24%) (Table 2.7).

“Other quality controls” are related for example to stability testing of vaccines. Increase in “Other quality controls” (+157%) was mainly due to studies involving fish larvae and no clear trend can be determined.

2015

2016

2017

Batch potency testing

1,032,235

945,013

892,723

Batch safety testing

228,817

152,443

139,602

Other quality controls

24,931

81,280

64,083

Pyrogenicity testing

46,553

39,434

35,172

Total

1,332,536

1,218,170

1,131,580

Table 2.7: Quality control related uses by type of use

III.2.2.2.1.2. Toxicity and other safety testing including pharmacology

Toxicity and other safety testing (including safety evaluation of products and devices for human medicine and dentistry and veterinary medicine) covers studies carried out on any product or substance to determine its potential to cause any dangerous or undesirable effects in humans or animals as a result of its intended or abnormal use, manufacture or as a potential or actual contaminant in the environment.

Toxicity and other safety testing including pharmacology represented more than 840,000 uses of animals in 2017, which corresponds to 9% of all uses of animals.

Most of the uses in this area were related to reproductive toxicity, repeated dose toxicity, pharmaco-dynamics, developmental toxicity, ecotoxicity and acute and sub-acute toxicity.

In 2017, proportionally highest severities were reported in following sub-categories: safety testing in food and feed area (24%), neurotoxicity (23%), ecotoxicity (21%), acute and sub-acute toxicity (18%).

Proportionally lowest severities were reported for skin irritation/corrosion, skin sensitisation, animal safety, kinetics, carcinogenicity, eye irritation/corrosion and reproductive toxicity (Figure 2.7).

Figure 2.7: Toxicity and other safety testing including pharmacology by type of use and severity in 2017

Between 2015 and 2017 (Table 2.8), the total number of uses for toxicity and other safety testing including pharmacology slightly decreased (-4%).

Reproductive toxicity related uses saw a significant increase (+45%) as well as safety testing in the food and feed area (+28%).

A significant decrease in the number of uses was observed in 2017 compared to 2015 for the following areas carcinogenicity (-48%), target animal safety (-42%), neurotoxicity (-72%) and eye irritation/corrosion (-46%) (Table 2.8).

“Other toxicity/safety testing” are related for example to metabolism pharmacokinetic or radiopharmacology.

2015

2016

2017

Reproductive toxicity

96,926

102,815

140,513

Repeated dose toxicity

119,910

111,720

114,573

Pharmaco-dynamics (incl safety pharmacology)

110,764

114,208

99,353

Developmental toxicity

113,026

117,435

97,671

Ecotoxicity

105,145

88,179

94,347

Acute and sub-acute

94,261

99,716

83,405

Kinetics

64,522

60,917

69,373

Skin sensitisation

49,549

51,645

47,341

Safety testing in food and feed area

35,723

40,310

45,800

Carcinogenicity

24,023

5,328

12,493

Other toxicity/safety testing

15,528

9,959

11,258

Genotoxicity

12,405

9,597

10,303

Target animal safety

15,118

12,022

8,717

Skin irritation/corrosion

4,773

3,222

4,120

Neurotoxicity

9,800

3,066

2,769

Eye irritation/corrosion

1,518

1,075

814

Phototoxicity

596

469

525

Total

873,587

831,683

843,375

Table 2.8: Toxicity and other safety testing including pharmacology by type of use

Acute and sub and sub-acute testing methods uses

Figure 2.8: Acute and sub-acute uses testing methods by type of uses and severity in 2017

2015

2016

2017

LD50, LC50

58,311

63,152

46,939

Non-lethal methods

32,120

31,406

31,218

Other lethal methods

3,830

5,158

5,248

Total

94,261

99,716

83,405

Table 2.9: Acute and sub-acute uses testing methods by type of use

Repeated dose toxicity uses

Figure 2.9: Repeated dose toxicity by type of uses and severity in 2017

2015

2016

2017

up to 28 days

73,692

55,323

61,344

29 - 90 days

28,023

34,558

34,931

> 90 days

18,195

21,839

18,298

Total

119,910

111,720

114,573

Table 2.10: Repeated dose toxicity by type of use

Ecotoxicity

Figure 2.10: Ecotoxicity by type of uses and severity in 2017

2015

2016

2017

Acute toxicity

60,094

46,581

44,915

Chronic toxicity

20,161

23,235

28,738

Other ecotoxicity

8,377

2,261

9,210

Endocrine activity

9,910

7,769

5,924

Bioaccumulation

2,950

4,258

4,110

Reproductive ecotoxicity

3,653

4,075

1,450

Total

105,145

88,179

94,347

Table 2.11: Ecotoxicity by type of use

III.2.2.2.1.3. Other efficacy and tolerance testing

This category of regulatory use refers to uses that are neither linked to quality control nor to toxicity testing. These uses are related to, for example, efficacy testing of biocides and pesticides as well as tolerance testing of additives in animal nutrition. They represented little more than 210,000 uses in 2017.

Figure 2.11: Other efficacy and tolerance testing by type of use and severity in 2017

Between 2015 and 2017, the total number of uses for other efficacy and tolerance testing increased (+29%) mostly due to the use of fish larvae for nutritional tests in 2016. In 2017, most of the procedures were mild (82%) with particularly low proportion of severe (2%) and non-recovery (0.6%) uses (Table 2.12).

2015

2016

2017

Other efficacy and tolerance testing

150,229

164,979

211,904

Table 2.12: Other efficacy and tolerance testing

III.2.2.2.2. Legislative aspects of regulatory uses

Figure 2.12: Regulatory uses by type of legislation in 2017

In 2017, the majority of uses to satisfy legislative requirements of specific sector legislation occurred in relation to placing on the market of medicinal products for humans (61%), veterinary medicinal products (15%) and industrial chemicals (11%) (Figure 2.12).

Between 2015 and 2017, the uses to satisfy legislative requirements for medical products for human use decreased (-12%) while those related to medical device legislation uses (+23%) and industrial chemicals legislation uses (+17%) saw an increase. No uses were reported under cosmetics legislation (Table 2.13).

2015

2016

2017

Legislation on medicinal products for human use

1,518,123

1,422,456

1,328,948

Legislation on medicinal products for veterinary use and their residues

368,571

337,054

325,486

Industrial chemicals legislation

195,950

214,772

230,177

Feed legislation including legislation for the safety of target animals, workers and environment

40,252

36,586

94,515

Plant protection product legislation

72,084

61,502

75,205

Medical devices legislation

47,270

48,944

58,312

Food legislation including food contact material

47,342

43,555

44,273

Other legislation

61,864

42,875

25,814

Biocides legislation

4,896

7,088

4,129

Total

2,356,352

2,214,832

2,186,859

Table 2.13: Regulatory uses by type of legislation

In 2017, the majority of regulatory uses were performed to satisfy regulatory requirements originating from the EU (95%). Non-EU requirements accounted for 4% and national requirements for 1% (Table 2.14).

The sub-category on legislation satisfying EU requirements also includes any requirements for which international harmonisation has been achieved, such as for testing to OECD, ICH 6 and VICH 7 standards. Harmonisation of testing requirements at a global level is of utmost importance when aiming to avoid unnecessary duplication of testing.

2015

2016

2017

Legislation satisfying EU requirements

94% (2,222,617)

93% (2,058,553)

95% (2,081,082)

Legislation satisfying Non-EU requirements only

4% (92,161)

5% (110,848)

4% (82,895)

Legislation satisfying national requirements only [within EU]

2% (41,574)

2% (45,431)

1% (22,882)

Total

100% (2,356,352)

100% (2,214,832)

100% (2,186,859)

Table 2.14: Regulatory uses by origin of regulatory requirement

Legislation on medicinal products for human or veterinary uses is mainly related to quality controls. Industrial chemical legislation and other legislations focus more specifically on toxicity testing. Feed legislation is mainly related to other efficacy testing.

It is important to note in this context that some of the data submissions still contained entries, which seem to indicate legislation irrelevant to the type of testing being carried out. Further efforts are being undertaken to improve the accuracy of the reporting (Table 2.15).

Quality control (incl batch safety and potency testing)

Toxicity and other safety testing including pharmacology

Other efficacy and tolerance testing

Legislation on medicinal products for human use

889,709

353,824

85,415

Legislation on medicinal products for veterinary use and their residues

239,687

46,810

38,989

Medical devices legislation

1,591

55,733

988

Industrial chemicals legislation

100

229,891

186

Plant protection product legislation

0

74,763

442

Biocides legislation

260

3,219

650

Food legislation including food contact material

0

44,187

86

Feed legislation including legislation for the safety of target animals, workers and environment

19

9,889

84,607

Other legislation

214

25,059

541

Total

1,131,580

843,375

211,904

Table 2.15: Regulatory use by type of legislation in 2017

In terms of severity levels, in 2017, for the legislative context, 16% of total uses in the area of regulatory testing were reported as severe, 24% as moderate, 59% mild (and up to mild) and 1% as non-recovery (Figure 2.2).

Even if the total numbers of uses are not the most significant in the area of food legislation, the proportion of severe uses is relatively high. This category included still in 2017 the use of mouse bioassay for the purposes of shellfish toxin testing. In the area of 'Other' legislations, 25% of procedures were reported as severe concerning mainly waste water toxicity studies on fish.

Figure 2.13: Regulatory use by type of legislation and severity in 2017

III.2.2.3. Routine production uses

Routine production includes the production of antibodies and blood products, including polyclonal antisera by established methods.

In 2017, there were about 469,000 routine production uses, which represented 5% of all uses of animals in the EU. 55% of routine uses were related to the production of blood-based products and 10% for monoclonal antibodies production by mouse ascites method (Figure 2.14).

Figure 2.14: Routine production uses by product type and severity in 2017

While blood based products involved only mild and moderate levels of severity, monoclonal antibody production by mouse ascites method involved mostly severe uses (70%) (Figure 2.14).

2015

2016

2017

Blood based products

271,393

260,228

259,780

Other product types

156,768

146,272

164,554

Monoclonal antibody by mouse ascites method

27,333

48,934

45,024

Total

455,494

455,434

469,358

Table 2.16: Routine production uses by product type

Other product types that represented 35% of the uses were mostly related to antigen and protein production.

Between 2015 and 2017, monoclonal antibody production by mouse ascites method saw an increase of 66%.

III.2.2.4. Other types of uses

Lastly, four categories of other uses are also reported as part of the Directive covering more than 367,000 uses: higher education and training for the acquisition, maintenance or improvement of vocational skills; protection of the natural environment in the interests of the health or welfare of human beings or animals; preservation of species; and forensic enquiries.

With 163,000 uses in 2017, higher education and training is the biggest category of the remaining purposes. At the same time, it is important to note that the severities linked to higher education and training, and on studies on preservation of species, are some of the lowest. Higher education has the largest proportion of non-recovery uses (31%). Forensic inquiry uses are limited to just a few hundreds. (Figure 2.15).

Figure 2.15: Other types of uses in 2017 including their severity

Between 2015 and 2017, there was an increase in the number of uses for the preservation of species (+107%) and protection of the natural environment (+16%), with important variations from one year to another due to studies on fish larvae where a single study can contain thousands of fish larvae (Table 2.17).

2015

2016

2017

Higher education or training for the acquisition, maintenance or improvement of vocational skills

162,424

164,495

163,762

Protection of the natural environment in the interests of the health or welfare of human beings or animals

104,834

78,403

124,787

Preservation of species

38,070

71,852

78,893

Forensic enquiries

315

915

473

Total

305,643

315,665

367,915

Table 2.17: Other types of uses

III.2.3. Information on reuses and genetic status of animals

The Directive requires additional elements to be recorded related to the use of animals for scientific purposes, such as reuse and information on the genetic status of the animals.

III.2.3.1. Reuses

In line with the principle of the Three Rs 8 , the total number of animals used in procedures can be reduced by performing procedures on animals more than once. However, this should only take place when this does not result in poor animal welfare, and is evaluated on a case-by-case basis. Under Directive 2010/63/EU, reuse of animals in procedures is permitted only under specific conditions related to the actual level of severity the animal has experienced in a previous procedure, and the health and well-being of the animal, taking into account the lifetime experience of the individual animal. A reuse cannot be authorised for a procedure, in which the animal may reach ‘severe’ level of pain, suffering or distress. Also, an animal may be reused following a severe procedure only in exceptional circumstances and after a veterinary examination of that animal.

Between 2015 and 2017, the proportion of reuses remained stable at 2% (Table 2.18)

2015

2016

2017

No

98% (9,590,379)

98% (9,817,946)

98% (9,388,162)

Yes

2% (192,191)

2% (210,552)

2% (193,579)

Total

100% (9,782,570)

100% (10,028,498)

100% (9,581,741)

Table 2.18: Reuses of animals used for research, testing, routine production and educational purposes

III.2.3.2.1. Animal species reused

In absolute numbers, the main species reused for scientific purposed in 2017 were mice, sheep, rats, rabbits, horses, donkeys and cross-breeds.

In proportions, large mammals are more often reused such as horses, donkeys and cross-breeds (82%), sheep (71%), cats (44%), dogs (36%) and cynomolgus monkeys (28%).

Reptiles (55%) and xenopus (37%) amongst amphibians were also often reused (Table 2.19).

Total number of uses

Number of reuses

Proportion of reuses

Mice

5,756,121

48,650

1%

Rats

1,164,167

17,868

2%

Guinea-Pigs

146,037

1,213

1%

Hamsters (Syrian)

12,723

23

0%

Mongolian gerbil

5,385

146

3%

Other Rodents

25,452

280

1%

Rabbits

364,431

12,470

3%

Cats

3,338

1,459

44%

Dogs

21,359

7,671

36%

Ferrets

2,112

96

5%

Other carnivores

2,514

128

5%

Horses, donkeys and cross-breeds

13,624

11,210

82%

Pigs

75,875

4,353

6%

Goats

2,268

705

31%

Sheep

65,527

46,715

71%

Cattle

37,276

6,633

18%

Prosimians

173

75

43%

Marmoset and tamarins

646

181

28%

Other species of New World Monkeys (Ceboidea)

3

0

0%

Cynomolgus monkey

10,007

2,780

28%

Rhesus monkey

628

275

44%

Vervets (Chlorocebus spp.)

53

20

38%

Baboons

46

21

46%

Other species of Old World Monkeys (Cercopithecoidea)

35

12

34%

Other Mammals

27,066

731

3%

Domestic fowl

472,012

7,459

2%

Other birds

102,346

2,936

3%

Reptiles

6,562

3,625

55%

Rana

3,498

13

0%

Xenopus

21,443

7,904

37%

Other Amphibians

10,946

263

2%

Zebra fish

504,183

4,420

1%

Other Fish

723,176

3,244

0%

Total

9,581,032

193,579

100%

Table 2.19: Reuses by type of species in 2017

III.2.3.2.2. Reuse by purposes of procedures

In 2017, routine production had the largest proportion of reuses (12%) mainly for blood-based products. The second most common use purpose for which animals have been reused was higher education and training (Table 2.20).

Total number of uses

Number of reuses

Proportion

Basic research

4,357,653

58,499

1%

Translational and applied research

2,199,956

29,798

1%

Regulatory use

2,186,859

34,863

2%

Routine production

469,358

55,826

12%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

163,762

13,323

8%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

124,787

1,259

1%

Preservation of species

78,893

11

0%

Forensic enquiries

473

0

0%

Table 2.20: Reuses by purposes in 2017

III.2.3.2.3. Severity of reuse

According to the Directive, reuse of an animal is not allowed in a procedure classified prospectively as severe. In 2017, most of the reuses, the actual reported severities were mild (74%) or moderate (19%) (Figure 2.16).

Figure 2.16: Reuses by severity in 2017

However, in some cases, even if the procedure is prospectively classified in a lower severity category, an individual animal may reach severity category "severe" due to unforeseen events occurring during the procedure. Only a very small number of such cases (<1 %) was reported.

These cases should be investigated by the user to eliminate any recurrence of any repetitive unforeseen adverse effects. Furthermore, these events, if recurring, may suggest a need for a revision of the prospective classification for future uses.

2015

2016

2017

Non-recovery

3% (5,067)

6% (12,157)

6% (12,240)

Mild [up to and including]

80% (152,817)

80% (168,387)

74% (143,478)

Moderate

18% (33,983)

14% (29,743)

19% (37,411)

Severe

0% (324)

0% (265)

0% (450)

Total

100% (192,191)

100% (210,552)

100% (193,579)

Table 2.21: Severity classification of reuse procedures

Between 2015 and 2017, the number of reuses remained stable in total with an increase of non-recovery reuses (+39%).

III.2.3.2. Use of genetically altered animals

Some of the animals used in procedures for purposes of research, testing, routine production and education are genetically altered. This section presents the types of genetic alteration reported. A welfare assessment is required to be performed on a newly created genetically altered animal line to establish whether the line is expected to have an intended non-harmful or harmful phenotype.

Intended non-harmful phenotypes include animal models where no adverse effects are noted during development, breeding and maintenance under conventional laboratory animal conditions. In addition, non-harmful phenotype lines include inducible and cre-lox lines, which require an active intervention for the harmful phenotype to be expressed.

Intended harmful phenotypes include animal models where gene alteration induces a specific genetic disorder or disease, or increases incidence of / susceptibility to for example tumour development. Other examples of harmful phenotype lines include those that require a specific bio-secure environment (for example, special housing arrangements to protect animals that are particularly sensitive to infection as a consequence of the gene alteration) or additional care beyond that required for conventional animals to maintain their health and well-being.

III.2.3.2.1. Type of genetic alteration

In 2017, 2.57 million uses for the purposes of research were carried out on animals that were genetically altered. Of these, 17% were of a harmful phenotypic alteration.

Figure 2.17: Uses of animals by type of genetic alteration in 2017

Between 2015 and 2017, the proportion of the uses of genetically altered animals for scientific purposes increased slightly. The percentage of the uses of such animals with a harmful phenotype increased from 4% to 5%, and the uses of such animals without a harmful phenotype increased from 21% to 23%.

2015

2016

2017

Genetically altered with a harmful phenotype

4% (397,525)

4% (435,075)

5% (432,206)

Genetically altered without a harmful phenotype

21% (2,038,618)

23% (2,344,954)

23% (2,157,696)

Not genetically altered

75% (7,346,427)

72% (7,248,469)

73% (6,991,839)

Total

100% (9,782,570)

100% (10,028,498)

100% (9,581,741)

Table 2.22: Genetic status of animals used

III.2.3.2.2. Genetically altered animals by species

Amongst the species, which have been genetically altered, uses of mice accounted for the highest numbers, followed by zebra fish and rats.

Even if mice accounts for the most animals being genetically altered, in proportion, 64% of zebra fish was genetically altered, followed by mice (38%), while only 3% of rats were genetically altered used in procedures for purposes of research, testing, routine production in 2017 (Table 2.23).

Total number of uses

Uses of genetically altered animals

Proportion

Zebra fish

504,183

323,741

64%

Mice

5,756,121

2,196,801

38%

Xenopus

21,443

2,146

10%

Rabbits

364,431

27,630

8%

Other Amphibians

10,946

671

6%

Rats

1,164,167

32,399

3%

Hamsters (Syrian)

12,723

187

1%

Other Fish

723,176

5,029

1%

Pigs

75,875

501

1%

Dogs

21,359

132

1%

Domestic fowl

472,012

637

<1%

Other Mammals

27,066

23

<1%

Sheep

65,527

5

<1%

Table 2.23: Genetically altered animals by species in 2017

This situation is mainly explained by the fact that genetically altered animals are used almost exclusively for research purposes. Indeed, in 2017, basic research accounted for 75% of uses of genetically altered animals and translational and applied research for 21% (Table 2.24).

Not genetically altered

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

Basic research

55% (2,413,441)

38% (1,642,212)

7% (302,000)

100% (4,357,653)

Translational and applied research

75% (1,655,814)

19% (416,794)

6% (127,348)

100% (2,199,956)

Regulatory use

98% (2,139,622)

2% (45,466)

0% (1,771)

100% (2,186,859)

Routine production

94% (441,479)

6% (27,879)

0% (0)

100% (469,358)

Higher education or training for the acquisition, maintenance or improvement of vocational skills

92% (150,292)

8% (12,769)

0% (701)

100% (163,762)

Preservation of species

84% (65,948)

16% (12,567)

0% (378)

100% (78,893)

Protection of the natural environment in the interests of the health or welfare of human beings or animals

100% (124,778)

0% (9)

0% (0)

100% (124,787)

Forensic enquiries

98% (465)

0% (0)

2% (8)

100% (473)

Table 2.24: Genetic status of animals by use purposes in 2017


III.3. Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU

In the context of Directive 2010/63/EU, Member States are also required to report the animals used in procedures for the creation of new genetically altered animal lines and the maintenance of colonies of established genetically altered animal lines to support the research needs in the EU.

Diagram in part III.3 provides further understanding of the reporting requirements for both creation and maintenance of genetically altered animal lines.

III.3.1. Numbers of animals used for the creation and maintenance of genetically altered animals

In 2017, 1,276,587 animals were used for the provision of genetically altered animals for the purposes of scientific research.

This included 634,705 animals used for the first time for the creation of new genetically altered animal lines (Table 3.5), and 641,882 animals used for the first time for the maintenance of colonies of established genetically altered animal lines (Table 3.9).

III.3.2. All uses of animals for the creation of new genetic altered animal lines

The creation of a new genetic altered animal line is reported under the research purpose category for which the line is being created for. The reporting covers all animals carrying the genetic alteration. In addition, those used for superovulation, vasectomy and embryo implantation are equally reported (these may or may not be genetically altered themselves). Genetically normal animals (wild type offspring) produced as a result of creation of a new genetically altered line are not reported in the annual statistics. (Diagram in Part III.4).

Counting all uses, the main species that were used for the creation of new genetic altered animal lines were mice and zebra fish, 75% and 23% respectively. Other species, although in small numbers, include rats, other species of fish, domestic fowl, rabbits, xenopus and pigs.

In 2017, the use of non-human primates (marmosets) for the creation of a new genetically altered line was reported for the first time in the EU.

Between 2015 and 2017, the creation of new genetic lines increased overall by 7% (Table 3.1).

2015

2016

2017

Mice

477,783

359,894

490,717

Zebra fish

124,359

122,082

150,596

Rats

4,381

6,039

9,960

Other Fish

2,556

10,737

4,569

Domestic fowl

279

515

647

Rabbits

272

967

475

Xenopus

7,259

1,100

250

Pigs

350

284

227

Other Mammals

4

0

61

Sheep

31

191

17

Marmoset and tamarins

0

0

10

Guinea-Pigs

0

47

0

Other Rodents

0

6

0

Total

617,274

501,862

657,529

Table 3.1: Uses of animals for the creation of new genetically altered animal lines by species

III.3.2.1. Creation of new genetically altered animal lines by genetic status

Animals that are not genetically altered but reported under the category creation of a new genetically altered animal lines include, for example, genetically normal parent animals or a part of the offspring that does not carry the genetic alteration. Of those that were genetically altered, over 86% were of a non-harmful phenotype.

Figure 3.1: Creation of new genetically altered animal lines: genetic types of animal used in 2017

2015

2016

2017

Not genetically altered

19% (114,485)

20% (102,718)

17% (110,523)

Genetically altered without a harmful phenotype

68% (421,006)

64% (320,567)

72% (474,189)

Genetically altered with a harmful phenotype

13% (81,783)

16% (78,577)

11% (72,817)

Total

100% (617,274)

100% (501,862)

100% (657,529)

Table 3.2: Creation of new genetically altered animal lines: genetic types of animal used

III.3.2.2. Creation of new genetically altered animals lines by scientific purposes

The creation of new genetic lines is only carried out for research purposes. In 2017, 658,000 uses (first and any subsequent reuses) were reported for the purposes of creating new genetically altered animal lines.

Figure 3.2: Creation of new genetically altered animal lines: uses for research purposes in 2017

95% of the new genetically altered lines were created for purposes covered under basic research. The table below presents all sub-categories from both basic and translational and applied research together.

In 2017, for basic research purposes, 21% concerned the multisystemic research (where more than one body system is the primary interest of the research, such as in some infectious diseases), 14% nervous system, 12% oncology and 10% cardiovascular, blood and lymphatic system (Table 3.3).

The most important sub-category under translational and applied research for which new genetically altered animal lines were created was human cancer (1%). Due to the relatively low number of uses for the creation of new genetically altered animal lines for the applied and translational research purposes, Table 3.3 combines all research purposes both from basic, and translational and applied research.

Between 2015 and 2017, the uses of animals for the creation of new genetic lines increased slightly (+7%), but with an important decrease in 2016 preventing the identification of any meaningful trend.

2015

2016

2017

Multisystemic

185,617

115,807

139,844

Nervous System

56,223

79,174

93,284

Oncology

62,747

63,869

81,862

Other basic research

124,948

41,976

81,265

Cardiovascular Blood and Lymphatic System

32,479

39,993

65,759

Immune System

33,598

45,225

59,533

Urogenital/Reproductive System

18,766

20,584

27,948

Sensory Organs (skin, eyes and ears)

8,859

27,505

18,974

Endocrine System/Metabolism

16,497

16,275

18,749

Musculoskeletal System

20,417

7,620

16,651

Gastrointestinal System including Liver

7,717

6,858

10,696

Human Cancer

15,392

14,162

9,416

Ethology / Animal Behaviour /Animal Biology

2,066

2,513

7,391

Human Endocrine/Metabolism Disorders

832

6,247

4,706

Human Nervous and Mental Disorders

2,569

2,950

4,090

Human Cardiovascular Disorders

4,887

2,491

3,712

Human Gastrointestinal Disorders including Liver

574

1,117

2,544

Human Immune Disorders

836

745

2,265

Animal Diseases and Disorders

916

465

1,851

Respiratory System

17,236

235

1,228

Human Infectious Disorders

1,652

847

1,220

Human Sensory Organ Disorders (skin, eyes and ears)

1,072

1,879

1,168

Human Musculoskeletal Disorders

353

965

881

Human Urogenital/Reproductive Disorders

262

481

654

Other Human Disorders

99

1,139

546

Non-regulatory toxicology and ecotoxicology

57

2

510

Diagnosis of diseases

229

239

502

Human Respiratory Disorders

263

407

263

Animal Welfare

111

92

17

Total

617,274

501,862

657,529

Table 3.3: Uses of animals for the creation of new genetically altered animal lines by type of research

III.3.2.3. Creation of new genetically altered animal lines by severity

Severities reported under the creation of new genetically altered animal lines include impacts from surgical techniques used during creation (embryo transfer; vasectomy), tissue sampling (using an invasive method for genotyping) and effects caused by the phenotype of the genetic alteration.

2015

2016

2017

Non-recovery

3% (17,031)

3% (16,007)

4% (25,467)

Mild [up to and including]

83% (514,080)

79% (394,322)

79% (519,551)

Moderate

12% (77,108)

16% (80,162)

15% (96,917)

Severe

1% (9,055)

2% (11,371)

2% (15,594)

Total

100% (617,274)

100% (501,862)

100% (657,529)

Table 3.4: Uses of animals for the creation of new genetically altered animal lines by severities

III.3.2.4. Reuses

2015

2016

2017

Yes

4% (26,241)

2% (8,706)

3% (22,824)

No

96% (591,033)

98% (493,156)

97% (634,705)

Total

100% (617,274)

100% (501,862)

100% (657,529)

Table 3.5: Reuse of animals used for the creation of new genetically altered animal lines

Between 2015 and 2017, the number of reuses for the creation of new genetic lines knew an important variation mainly explained by the uses of zebra fish.

Yes

No

Mice

<1% (2,120)

100% (488,597)

Rats

0% (0)

100% (9,960)

Rabbits

0% (0)

100% (475)

Pigs

1% (3)

99% (224)

Sheep

0% (0)

100% (17)

Marmoset and tamarins

0% (0)

100% (10)

Other Mammals

0% (0)

100% (61)

Domestic fowl

0% (0)

100% (647)

Xenopus

0% (0)

100% (250)

Zebra fish

14% (20,701)

86% (129,895)

Other Fish

0% (0)

100% (4,569)

Total

3% (22,824)

97% (634,705)

Table 3.6: Reuses by species for the creation of new genetically altered animal lines in 2017

In 2017, the only species of reused animals were zebra fish, mice and pigs (Table 3.6).

III.3.3. All uses of animals for the maintenance of colonies of established genetically altered animal lines

Directive 2010/63/EU requires Member States to report animals used for the maintenance of colonies for genetically altered animals. This category contains animals required for the maintenance of colonies of genetically altered animals of established lines with an intended harmful phenotype and which have exhibited pain, suffering, distress or lasting harm as a consequence of the harmful genotype before being killed.

This category also includes genetically altered animals of an established line, irrespective of whether the line is of non-harmful or harmful phenotype, and

•for which the genotype has been confirmed using an invasive method (tissue sampling/
genotyping), which was not carried out for the purposes of marking of the animal, and the animal is killed without further use;

•that are of unsuitable genotype, confirmed using an invasive method, which was not carried out for the purposes of marking of the animal.

Given the complexity of the reporting obligations, errors in the reporting of uses under maintenance of colonies are still being detected. In addition, some Member States apply different reporting rules for their national reporting, which has, in some cases, resulted in incorrect
(over-) reporting for EU purposes, whilst at the same time it seems that not all genotyping using invasive methods has been correctly reported by all Member States, resulting in under-reporting for EU purposes.

Consequently, the level of confidence in the numbers reported under the maintenance of colonies at this early stage, is still relatively low, and any year-to-year comparisons are for the time being discouraged. The Commission is working together with Member States to improve the situation. The identification and correction of some of the misunderstandings of the reporting obligations is likely to explain some of the decrease in total numbers noted for the maintenance of colonies between 2015 and 2017.

III.3.3.1. Maintenance of colonies of established genetically altered animal lines by genetic status

In 2017, 642,000 uses were reported under the maintenance of colonies of established genetically altered animal lines. Amongst these uses, 74% were genetically altered without a harmful phenotype, 20% with a harmful phenotype and 6% without genetic alteration (Figure 3.3). This seems to suggest that the majority of uses reported under maintenance of colonies of established genetically altered animal lines concern animals that have been genotyped using an invasive method. Those reported with a harmful phenotype are likely to be a mix of those that were genotyped and those having exhibited the harmful phenotype before being killed.

Figure 3.3: Genetic status of animals used for the maintenance of colonies of established genetically altered animal lines in 2017

III.3.3.2. Maintenance of colonies of established genetically altered animal lines by severity

In 2017, in 79% of the uses the severities remained at mild (and up to mild) level (Table 3.7). Drawing from the previous figure 3.3 in which it was stated that almost 74% percent of animals were of non-harmful phenotype, the severities seem to relate to the effects of tissue sampling (invasive genotyping). For those classed as having a harmful-phenotype, the severities can be linked to the phenotype and invasive tissue sampling. Where animals are found dead with no clear reason, this results in reporting these as ‘severe’.

2015

2016

2017

Non-recovery

1% (5,790)

0% (1,031)

0% (740)

Mild [up to and including]

84% (842,365)

87% (609,140)

79% (510,466)

Moderate

9% (85,781)

7% (51,298)

13% (83,866)

Severe

7% (67,250)

6% (40,040)

7% (47,760)

Total

100% (1,001,186)

100% (701,509)

100% (642,832)

Table 3.7: Uses of animals for the maintenance of colonies of genetically altered animal lines by severity in 2017

III.3.3.2. Maintenance of colonies of established genetically altered animal lines by species

Mice and zebra fish are the most common genetically altered animals used for scientific purposes, and are therefore the main species also used for the maintenance of colonies.

2015

2016

2017

Mice

910,724

623,988

563,784

Rats

9,003

9,294

6,799

Dogs

7

17

10

Other Mammals

0

4

0

Domestic fowl

322

582

367

Xenopus

188

259

392

Zebra fish

80,632

66,794

70,840

Other Fish

310

571

640

Total

1,001,186

701,509

642,832

Table 3.8: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species


III.3.3.3. Reuses

2015

2016

2017

Yes

4,193

973

950

No

996,993

700,536

641,882

Total

1,001,186

701,509

642,832

Table 3.9: Reuses of animals for the maintenance of colonies of established genetically altered animal lines

These reuses involved three types of species: zebra fish, xenopus and mice.

Yes

No

Mice

141

563,643

Rats

0

6,799

Dogs

0

10

Domestic fowl

0

367

Xenopus

197

195

Zebra fish

612

70,228

Other Fish

0

640

Total

950

641,882

Table 3.10: Reuses by species for the maintenance of colonies of established genetically altered animal lines



III.4. Glossary of terms

Species of animals

The Directive applies to live non-human vertebrate animals, including independently feeding larval forms and foetal forms of mammals as from the last third of their normal development, and live cephalopods.

Larval forms and cephalopods are reported in the statistics when they become capable of independent feeding. Due to the small size of many larval forms of fish and cephalopod species, the count for these animals may be done on the basis of estimation.

Procedure

"Procedure" means any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.

This includes any course of action intended, or liable, to result in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition, but excludes the killing of animals solely for the use of their organs or tissues.

Use and reuse

The “use” of an animal within a project extends from the time the procedure (or first procedure/technique in a series) is applied to it, to the time when the observations, or the collection of data (or other products) for a particular scientific purpose (usually a single experiment or test), are completed.

“Reuse” is a term to indicate any subsequent use of an animal, which has already completed a procedure (or series of procedures/techniques) for a particular scientific purpose. Article 16 of the Directive on reuse defines it as a use when a different animal on which no procedure has previously been carried out could also be used. Article 16 also defines the conditions under which an animal may be reused.

Reporting of actual severity experienced by the animals

The impact on animal welfare is reported by assigning an animal’s experience to a ‘severity’ category – "mild", "moderate" or "severe". There is a further category termed "non-recovery" which relates to where animals are placed under general anesthesia before they are used and are killed afterwards before regaining consciousness.

The reported severity reflects the highest degree of pain, suffering, distress or lasting harm observed to be actually experienced by the animal during the course of its use. Further guidance on severity assessment can be found at     http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Endorsed_Severity_Assessment.pdf .

I.Non-recovery - Animals which have undergone a procedure that has been performed entirely under general anaesthesia from which the animal has not recovered consciousness shall be reported as Non-recovery.

II.Mild (up to and including) - Animals which have undergone a procedure as a result of which the animals have experienced short-term mild pain, suffering or distress, as well as when there has been no significant impairment of the well-being or general condition of the animals shall be reported as Mild.

This cateogry also includes any animals used in an authorised project, but which have ultimately not been observed to have experienced a level of pain, suffering, distress or lasting harm above the minimum threshold (equivalent to that caused by the introduction of a needle in accordance with good veterinary practice) for example untreated control animals (“up to mild”). However, animals required for the maintenance of colonies of genetically altered animals of established lines with an intended harmful phenotype and which have not exhibited pain, suffering, distress or lasting harm as a consequence of the harmful genotype are not reported in annual statistics.

III.Moderate - Animals which have undergone a procedure as a result of which the animals have experienced short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that have caused moderate impairment of the well-being or general condition of the animals shall be reported as Moderate.

IV.Severe - Animals which have undergone a procedure as a result of which the animals have experienced severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that have caused severe impairment of the well-being or general condition of the animals shall be reported as Severe.

In the exceptional circumstances where, under the safeguard clause, the Severe classification is exceeded these animals and their use will be reported under Severe. Should this occur, further explanation on the circumstances of this use is provided in the respective Member State narrative.

Genetically altered animals

For the purposes of statistical reporting, "genetically altered animals" refer to either of the following:

·genetically modified (such as transgenic, knock-out and other forms of genetic alteration) and induced mutant animals (irrespective of the type of mutation);

·animals with spontaneous deleterious mutations maintained for research for that specific genotype.

Genetically altered animals are reported either

a)When used for the creation of a new animal line;

b)When used for the maintenance of an established line with an intended and exhibited harmful phenotype; This category also includes genetically altered animals during maintenance of an established line, irrespective of whether the line is of intended non-harmful or harmful phenotype, that have been subject to invasive genotyping (genetic characterisation/tissue sampling);

c)When used in other (scientific) procedures (i.e. not for the creation or the maintenance of a line).

The reporting of genetically altered animals are summarised in the above table.

Creation

All animals carrying a genetic alteration are reported during the creation of a new line. Also, those used for superovulation, vasectomy and embryo implantation are reported (these may or may not be genetically altered).

Genetically normal animals (wild-type offspring) produced as a result of the creation of a new genetically altered line are not reported, unless these have been subjected to a procedure, for example an invasive method for the sole purposes of genotyping.

Establishment and maintenance of breeding colonies

A new strain or line of genetically altered animals is considered to be “established” when transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed. This marks the transition from "creation" to "breeding".

The welfare assessment determines if the newly established line is expected to have an intended harmful phenotype (characteristic/trait) i.e. an effect of genetic alteration that impacts negatively on an animal’s health or welfare, such as muscle weakness, diabetes, tumour development.

If the welfare assessment concludes that the line is not expected to have a harmful phenotype, its breeding falls outside the scope of a procedure and is not reported in the annual statistics.

If the welfare assessment concludes that the line is expected to have a harmful phenotype, its breeding falls within the scope of a procedure. If this is the case, and if the animal is not used in other procedures and it has exhibited, before being killed, pain, suffering, distress of lasting harm as a result of the harmful phenotype, it is reported under the category Maintenance of colonies of established genetically altered animals, not used in other procedures.

Use in procedures (other than creation or maintenance of a genetically altered line)

All genetically altered animals which are used in procedures (not for the creation or maintenance of a genetically altered line) are reported under their respective purposes they were used for(. These animals may or may not exhibit a harmful phenotype.



Diagram for the reporting of the creation, maintenance and use of genetically altered animals

Main categories of purposes of uses for research, testing, routine production and education (including training)

Basic research

Basic research includes studies of a fundamental nature including physiology. Studies that are designed to add knowledge about normal and abnormal structure, functioning and behaviour of living organisms and environment, this includes fundamental studies in toxicology. Investigation and analysis focused on a better or fuller understanding of a subject, phenomenon, or a basic law of nature instead of on a specific practical application of the results.

Translational and applied research

Translational and applied research includes animals used for purposes as described in Article 5(b) and (c) of the Directive, that is to say,

“(b) translational or applied research with any of the following aims:

(i) the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants;

(ii) the assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants; or

(iii) the welfare of animals and the improvement of the production conditions for animals reared for agricultural purposes;

(c) for any of the aims in point (b) in the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs and other substances or products;”

This category also includes discovery toxicology and investigations to prepare for the regulatory submission and method development. This does not include studies required for regulatory submissions.

Regulatory use

Regulatory uses cover the use of animals in procedures with a view to satisfying regulatory requirements, that is to say, for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed. It also includes tests carried out in respect of products/substances for which a regulatory submission was foreseen but ultimately not made, for instance because these were deemed unsuitable for the market by the developer and thus fail to reach the end of the development process.

Routine production

Routine production includes the production of antibodies and blood products including polyclonal antisera by established methods.

Protection of the natural environment in the interests of the health or welfare of human beings or animals

This category includes studies aimed at investigating and understanding phenomena such as environmental pollution, loss of biodiversity, and epidemiology studies in wild animals. This excludes any regulatory use of animals for ecotoxicology purposes.

Preservation of species

Studies aimed at conserving species, often those at risk of extinction, for example to investigate improved breeding strategies or preservation of habitats.

Higher education or training

This category covers the use of animals for the purposes of education and also for the acquisition, maintenance or improvement of vocational skills.

Forensic enquiries

Studies to assist the investigation of forensic enquiries. 

(1)

 Directive 2010/63/EU OJ L276, 20.10.2010, p.33-79  

(2)

OJ L 170, 25.6.2019, p. 115–127

(3)

OJ L 358 , 18/12/1986 P. 0001 - 0028

(4)

“Research and testing” covers animals used for research, testing, routine production and education (including animals used for training purposes)

(5)

 In this context ‘Research’ means basic, applied and translational research, animals used for the purposes of protection of the natural environment in the interests of the health or welfare of human beings or animals, preservation of the species and forensic enquiries; ‘testing’ refers to regulatory use of animals and ‘education’ includes animals used for training purposes. Glossary in III.4. provides further information on some of the categories of scientific use purposes.

(6)

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

(7)

 The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

(8)

 To Replace, Reduce and Refine the use of animals in scientific procedures

Top

Brussels, 5.2.2020

SWD(2020) 10 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017













{COM(2020) 16 final}


SECTION B: EU DATA BETWEEN 2015 AND 2017

IV. Detailed EU tables 2015 - 2017

This section presents the basic consolidated tables used for the conclusions at the EU level.

SECTION B: EU DATA BETWEEN 2015 AND 2017    

IV. Detailed EU tables 2015 - 2017    

EU statistical tables 2015    

Part 1: Numbers of animals used for research, testing, routine production and educational purposes in the EU    

Part 2: Details of all uses of animals for research, testing, routine production and educational purposes in the EU    

Part 3: Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU    

EU statistical tables 2016    

Part 1: Numbers of animals used for research, testing, routine production and educational purposes in the EU    

Part 2: Details of all uses of animals for research, testing, routine production and educational purposes in the EU    

Part 3: Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU    

EU statistical tables 2017    

Part 1: Numbers of animals used for research, testing, routine production and educational purposes in the EU    

Part 2: Details of all uses of animals for research, testing, routine production and educational purposes in the EU    

Part 3: Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU    



EU statistical tables 2015



Part 1: Numbers of animals used for research, testing, routine production and educational purposes in the EU



Table 1: Numbers of animals used for the first time by species (2015)

Number of animals

%

Mammals

Rodents

Mice

5,711,612

59.6

Rats

1,201,189

12.5

Guinea-Pigs

149,328

1.6

Hamsters (Syrian)

20,195

0.2

Hamsters (Chinese)

30

0

Mongolian gerbil

6,199

0.1

Other rodents

26,088

0.3

Rabbits

Rabbits

346,052

3.6

Carnivores

Cats

1,975

0

Dogs

14,501

0.2

Ferrets

2,212

0

Other carnivores

3,648

0

Farm animals

Horses, donkeys and cross-breeds

3,217

0

Pigs

73,895

0.8

Goats

2,233

0

Sheep

20,106

0.2

Cattle

26,763

0.3

Non-human primates

Prosimians

169

0

Marmoset and tamarins

429

0

Squirrel monkey

13

0

Other species of new world monkeys (Ceboidea)

0

0

Cynomolgus monkey

6,221

0.1

Rhesus monkey

211

0

Vervets (Chlorocebus spp.)

56

0

Baboons

37

0

Other species of old world monkeys (Cercopithecoidea)

0

0

Other mammals

Other mammals

9,535

0.1

Birds

Domestic fowl

515,834

5.4

Other birds

119,377

1.2

Reptiles

Reptiles

2,414

0

Amphibians

Rana

4,884

0.1

Xenopus

10,837

0.1

Other amphibians

20,190

0.2

Fish

Zebra fish

338,815

3.5

Other fish

936,252

9.8

Cephalopods

Cephalopods

15,862

0.2

Totals

Total

9,590,379

100

%

100



Table 2: Place of birth by species (other than non-human primates) (2015)

Animals born in the EU at a registered breeder

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

%

Mammals

Rodents

Mice

5,466,761

170,399

38,177

36,275

5,711,612

59.6

Rats

1,185,595

9,656

705

5,233

1,201,189

12.5

Guinea-Pigs

148,500

828

0

0

149,328

1.6

Hamsters (Syrian)

19,310

83

7

795

20,195

0.2

Hamsters (Chinese)

30

0

0

0

30

0

Mongolian gerbil

5,841

290

0

68

6,199

0.1

Other rodents

8,501

17,130

57

400

26,088

0.3

Rabbits

Rabbits

337,709

5,448

173

2,722

346,052

3.6

Carnivores

Cats

1,053

531

0

391

1,975

0

Dogs

6,109

3,752

52

4,588

14,501

0.2

Ferrets

1,796

148

0

268

2,212

0

Other carnivores

1,088

2,556

4

0

3,648

0

Farm animals

Horses, donkeys and cross-breeds

700

2,517

0

0

3,217

0

Pigs

35,355

37,327

1,203

10

73,895

0.8

Goats

805

1,428

0

0

2,233

0

Sheep

6,503

13,505

98

0

20,106

0.2

Cattle

8,677

17,993

93

0

26,763

0.3

Other mammals

Other mammals

2,078

5,967

18

1,472

9,535

0.1

Birds

Domestic fowl

266,406

244,616

4,800

12

515,834

5.4

Other birds

19,867

92,967

3,244

3,299

119,377

1.2

Reptiles

Reptiles

459

1,557

42

356

2,414

0

Amphibians

Rana

3,194

1,540

150

0

4,884

0.1

Xenopus

7,952

312

0

2,573

10,837

0.1

Other amphibians

1,816

17,039

247

1,088

20,190

0.2

Fish

Zebra fish

320,358

15,458

812

2,187

338,815

3.5

Other fish

594,363

292,494

44,337

5,058

936,252

9.8

Cephalopods

Cephalopods

15,840

22

0

0

15,862

0.2

Totals

Total

8,466,666

955,563

94,219

66,795

9,583,243

100

%

88.3

10

1

0.7

100



Table 3: Source of non-human primates by species (2015)

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

%

Non-human primates

New World Monkeys

Prosimians

158

11

0

0

0

0

169

2.4

Marmoset and tamarins

429

0

0

0

0

0

429

6

Squirrel monkey

10

0

0

3

0

0

13

0.2

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

Old World Monkeys

Cynomolgus monkey

146

0

2,052

9

3,923

91

6,221

87.2

Rhesus monkey

175

3

33

0

0

0

211

3

Vervets (Chlorocebus spp.)

4

0

0

52

0

0

56

0.8

Baboons

37

0

0

0

0

0

37

0.5

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

Totals

Total

959

14

2,085

64

3,923

91

7,136

100

%

13.4

0.2

29.2

0.9

55

1.3

100

Table 4: Generation of non-human primates by species (2015)

F0

F1

F2 or greater

Self-sustaining colony

Total

%

Non-human primates

New World Monkeys

Prosimians

0

1

0

168

169

2.4

Marmoset and tamarins

0

0

102

327

429

6

Squirrel monkey

0

8

5

0

13

0.2

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

Old World Monkeys

Cynomolgus monkey

1

1,737

2,420

2,063

6,221

87.2

Rhesus monkey

0

22

55

134

211

3

Vervets (Chlorocebus spp.)

0

4

0

52

56

0.8

Baboons

0

1

32

4

37

0.5

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

Totals

Total

1

1,773

2,614

2,748

7,136

100

%

0

24.8

36.6

38.5

100



Part 2: Details of all uses of animals for research, testing, routine production and educational purposes in the EU



Table 5: Uses of animals by species, main categories of scientific purposes and severities (2015)

Severity

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Non-recovery

249,177

121,186

10,856

2

0

380

14,674

4

396,279

6.9

Mild

1,521,311

551,716

578,720

3,059

3,178

6,338

38,369

36

2,702,727

46.9

Moderate

1,047,417

663,033

284,691

16,948

200

0

18,851

0

2,031,140

35.2

Severe

188,709

107,101

326,302

13,673

243

0

630

0

636,658

11.0

Total

3,006,614

1,443,036

1,200,569

33,682

3,621

6,718

72,524

40

5,766,804

100.0

Rats

Non-recovery

50,257

30,045

8,639

76

0

32

22,163

1

111,213

9.1

Mild

117,925

120,119

365,129

1,162

562

127

13,426

100

618,550

50.8

Moderate

132,492

118,106

176,306

36

493

0

6,539

0

433,972

35.7

Severe

28,512

15,030

9,007

176

96

0

12

0

52,833

4.3

Total

329,186

283,300

559,081

1,450

1,151

159

42,140

101

1,216,568

100.0

Guinea-Pigs

Non-recovery

907

16,936

1,218

270

0

0

245

17

19,593

13.0

Mild

2,351

6,091

61,775

1,115

0

0

1,834

0

73,166

48.7

Moderate

1,172

2,285

38,110

45

0

0

277

19

41,908

27.9

Severe

85

702

14,690

0

0

0

0

0

15,477

10.3

Total

4,515

26,014

115,793

1,430

0

0

2,356

36

150,144

100.0

Hamsters (Syrian)

Non-recovery

525

183

0

0

0

0

17

0

725

3.6

Mild

246

2,089

5,946

7

0

0

94

0

8,382

41.4

Moderate

929

4,646

1,019

0

0

0

0

0

6,594

32.6

Severe

77

563

3,725

173

0

0

0

0

4,538

22.4

Total

1,777

7,481

10,690

180

0

0

111

0

20,239

100.0

Hamsters (Chinese)

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

0

0

30

0

0

0

0

0

30

100.0

Moderate

0

0

0

0

0

0

0

0

0

0.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

30

0

0

0

0

0

30

100.0

Mongolian gerbil

Non-recovery

268

0

0

0

0

0

26

0

294

4.5

Mild

644

1,570

1,489

167

0

0

23

0

3,893

59.0

Moderate

523

949

110

19

0

0

30

0

1,631

24.7

Severe

112

667

6

0

0

0

0

0

785

11.9

Total

1,547

3,186

1,605

186

0

0

79

0

6,603

100.0

Other rodents

Non-recovery

559

0

0

0

0

42

83

0

684

2.5

Mild

5,646

1,977

8,354

38

647

113

175

0

16,950

63.1

Moderate

8,010

404

82

0

0

160

2

0

8,658

32.2

Severe

81

509

1

0

0

0

0

0

591

2.2

Total

14,296

2,890

8,437

38

647

315

260

0

26,883

100.0

Rabbits

Non-recovery

5,793

2,785

3,124

0

0

0

952

0

12,654

3.5

Mild

5,867

5,401

75,619

165,138

233

0

837

0

253,095

70.1

Moderate

7,310

6,991

23,119

48,056

0

0

279

0

85,755

23.7

Severe

2,926

871

1,159

4,738

4

0

0

0

9,698

2.7

Total

21,896

16,048

103,021

217,932

237

0

2,068

0

361,202

100.0

Cats

Non-recovery

68

0

1

0

0

0

0

0

69

2.2

Mild

635

565

987

0

0

0

48

0

2,235

70.2

Moderate

100

325

159

18

0

0

1

0

603

18.9

Severe

0

225

53

0

0

0

0

0

278

8.7

Total

803

1,115

1,200

18

0

0

49

0

3,185

100.0

Dogs

Non-recovery

14

219

328

2

6

0

10

0

579

2.7

Mild

1,264

6,302

7,335

237

6

0

521

0

15,665

72.1

Moderate

56

1,466

3,382

0

0

0

14

0

4,918

22.6

Severe

21

365

191

0

0

0

0

0

577

2.7

Total

1,355

8,352

11,236

239

12

0

545

0

21,739

100.0

Ferrets

Non-recovery

111

0

0

0

0

0

14

0

125

5.3

Mild

61

745

680

6

0

0

70

0

1,562

66.4

Moderate

172

295

151

0

0

0

17

0

635

27.0

Severe

0

22

8

0

0

0

0

0

30

1.3

Total

344

1,062

839

6

0

0

101

0

2,352

100.0

Other carnivores

Non-recovery

5

0

0

2

0

0

0

0

7

0.2

Mild

1,583

696

220

0

170

62

0

0

2,731

73.3

Moderate

169

176

622

0

0

0

0

0

967

26.0

Severe

9

10

0

0

0

0

0

0

19

0.5

Total

1,766

882

842

2

170

62

0

0

3,724

100.0

Horses, donkeys and cross-breeds

Non-recovery

78

35

0

0

0

34

24

0

171

1.4

Mild

2,418

890

141

7,669

1

0

265

0

11,384

94.3

Moderate

100

292

12

107

0

0

0

0

511

4.2

Severe

0

0

0

2

0

0

0

0

2

0.0

Total

2,596

1,217

153

7,778

1

34

289

0

12,068

100.0

Pigs

Non-recovery

5,366

2,719

9

21

0

0

5,962

0

14,077

18.2

Mild

14,887

15,664

12,225

255

780

3

2,549

0

46,363

59.9

Moderate

4,217

7,474

2,456

15

8

0

964

0

15,134

19.6

Severe

429

1,168

229

0

0

0

0

0

1,826

2.4

Total

24,899

27,025

14,919

291

788

3

9,475

0

77,400

100.0

Goats

Non-recovery

0

46

0

0

0

0

6

0

52

2.0

Mild

829

948

115

22

0

0

184

0

2,098

79.4

Moderate

85

366

6

5

10

0

8

0

480

18.2

Severe

8

3

0

0

0

0

0

0

11

0.4

Total

922

1,363

121

27

10

0

198

0

2,641

100.0

Sheep

Non-recovery

96

212

16

0

0

0

571

0

895

1.4

Mild

6,412

6,717

1,892

40,923

370

62

756

121

57,253

91.1

Moderate

1,535

2,018

73

136

2

0

149

0

3,913

6.2

Severe

398

407

0

0

0

0

0

0

805

1.3

Total

8,441

9,354

1,981

41,059

372

62

1,476

121

62,866

100.0

Cattle

Non-recovery

111

32

0

0

0

0

8

0

151

0.4

Mild

14,047

8,885

3,489

138

715

0

3,246

6

30,526

84.0

Moderate

1,610

1,629

479

15

11

0

1,599

0

5,343

14.7

Severe

23

293

12

0

0

0

9

0

337

0.9

Total

15,791

10,839

3,980

153

726

0

4,862

6

36,357

100.0

Prosimians

Non-recovery

2

0

0

0

0

0

0

0

2

0.8

Mild

189

0

0

0

0

0

0

0

189

73.0

Moderate

65

1

0

0

0

0

0

0

66

25.5

Severe

2

0

0

0

0

0

0

0

2

0.8

Total

258

1

0

0

0

0

0

0

259

100.0

Marmoset and tamarins

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

147

24

124

84

0

0

6

0

385

62.7

Moderate

108

57

38

0

0

0

0

0

203

33.1

Severe

18

8

0

0

0

0

0

0

26

4.2

Total

273

89

162

84

0

0

6

0

614

100.0

Squirrel monkey

Non-recovery

4

0

0

0

0

0

0

0

4

30.8

Mild

2

0

0

0

0

0

0

0

2

15.4

Moderate

7

0

0

0

0

0

0

0

7

53.8

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

13

0

0

0

0

0

0

0

13

100.0

Other species of new world monkeys (Ceboidea)

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

24

0

0

0

0

0

0

0

24

100.0

Moderate

0

0

0

0

0

0

0

0

0

0.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

24

0

0

0

0

0

0

0

24

100.0

Cynomolgus monkey

Non-recovery

15

74

8

10

0

0

0

0

107

1.1

Mild

30

531

3,513

2,053

0

0

23

0

6,150

65.4

Moderate

95

460

2,336

0

0

0

0

0

2,891

30.8

Severe

0

132

118

1

0

0

0

0

251

2.7

Total

140

1,197

5,975

2,064

0

0

23

0

9,399

100.0

Rhesus monkey

Non-recovery

21

1

0

0

0

0

0

0

22

4.8

Mild

81

109

54

32

0

0

5

0

281

61.9

Moderate

113

38

0

0

0

0

0

0

151

33.3

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

215

148

54

32

0

0

5

0

454

100.0

Vervets (Chlorocebus spp.)

Non-recovery

0

39

0

0

0

0

0

0

39

69.6

Mild

0

13

0

0

0

0

0

0

13

23.2

Moderate

0

4

0

0

0

0

0

0

4

7.1

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

0

56

0

0

0

0

0

0

56

100.0

Baboons

Non-recovery

0

2

0

0

0

0

0

0

2

4.8

Mild

1

0

0

0

0

0

0

0

1

2.4

Moderate

11

18

0

0

0

0

0

0

29

69.0

Severe

0

10

0

0

0

0

0

0

10

23.8

Total

12

30

0

0

0

0

0

0

42

100.0

Other species of old world monkeys (Cercopithecoidea)

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

8

1

0

0

0

0

0

0

9

100.0

Moderate

0

0

0

0

0

0

0

0

0

0.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

8

1

0

0

0

0

0

0

9

100.0

Other mammals

Non-recovery

997

86

0

0

0

0

0

0

1,083

9.7

Mild

6,445

1,303

125

34

544

205

73

0

8,729

78.0

Moderate

990

345

15

0

0

0

0

0

1,350

12.1

Severe

14

6

0

12

0

0

0

0

32

0.3

Total

8,446

1,740

140

46

544

205

73

0

11,194

100.0

Domestic fowl

Non-recovery

8,840

3,226

120

379

0

0

607

0

13,172

2.5

Mild

53,827

60,665

138,520

91,027

2,485

939

6,029

0

353,492

67.8

Moderate

84,815

15,538

24,207

15,283

34

0

526

0

140,403

26.9

Severe

914

7,268

5,614

231

58

0

0

0

14,085

2.7

Total

148,396

86,697

168,461

106,920

2,577

939

7,162

0

521,152

100.0

Other birds

Non-recovery

1,400

20

80

0

0

6

6

0

1,512

1.2

Mild

44,392

13,725

5,186

521

2,740

573

602

11

67,750

55.7

Moderate

6,112

3,899

429

41,031

0

45

18

0

51,534

42.4

Severe

88

160

599

0

1

0

0

0

848

0.7

Total

51,992

17,804

6,294

41,552

2,741

624

626

11

121,644

100.0

Reptiles

Non-recovery

505

0

0

0

0

0

0

0

505

13.2

Mild

2,274

0

0

300

93

0

33

0

2,700

70.5

Moderate

581

0

0

0

0

46

0

0

627

16.4

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

3,360

0

0

300

93

46

33

0

3,832

100.0

Rana

Non-recovery

25

0

0

0

0

0

206

0

231

4.7

Mild

85

0

0

0

0

0

789

0

874

17.9

Moderate

4

0

132

0

600

0

1,865

0

2,601

53.3

Severe

1,178

0

0

0

0

0

0

0

1,178

24.1

Total

1,292

0

132

0

600

0

2,860

0

4,884

100.0

Xenopus

Non-recovery

528

0

0

0

0

0

188

0

716

3.8

Mild

13,844

703

719

0

8

0

57

0

15,331

80.7

Moderate

1,310

551

0

0

840

0

0

0

2,701

14.2

Severe

241

0

1

0

0

0

0

0

242

1.3

Total

15,923

1,254

720

0

848

0

245

0

18,990

100.0

Other amphibians

Non-recovery

1,262

0

0

0

5

0

49

0

1,316

6.4

Mild

3,966

57

0

0

6,692

3,881

200

0

14,796

72.4

Moderate

2,560

7

60

0

0

12

2

0

2,641

12.9

Severe

1,476

0

0

0

205

0

0

0

1,681

8.2

Total

9,264

64

60

0

6,902

3,893

251

0

20,434

100.0

Zebra fish

Non-recovery

7,702

585

635

0

21

0

124

0

9,067

2.6

Mild

200,713

28,169

20,063

0

3,996

0

1,426

0

254,367

74.1

Moderate

26,004

22,065

15,495

0

200

0

89

0

63,853

18.6

Severe

4,172

4,931

6,872

0

3

0

0

0

15,978

4.7

Total

238,591

55,750

43,065

0

4,220

0

1,639

0

343,265

100.0

Other fish

Non-recovery

15,185

3,694

1,922

0

10,565

3,999

1,303

0

36,668

3.9

Mild

516,527

63,729

71,130

25

61,392

18,759

11,442

0

743,004

79.1

Moderate

48,780

40,111

5,524

0

2,899

2,252

191

0

99,757

10.6

Severe

18,371

19,884

18,216

0

3,718

0

20

0

60,209

6.4

Total

598,863

127,418

96,792

25

78,574

25,010

12,956

0

939,638

100.0

Cephalopods

Non-recovery

0

8

0

0

0

0

12

0

20

0.1

Mild

2

15,840

0

0

0

0

0

0

15,842

99.9

Moderate

0

0

0

0

0

0

0

0

0

0.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

2

15,848

0

0

0

0

12

0

15,862

100.0

All Species

Non-recovery

349,821

182,133

26,956

762

10,597

4,493

47,250

22

622,034

6.4

Mild

2,538,683

915,244

1,363,580

314,012

84,612

31,062

83,082

274

5,330,549

54.5

Moderate

1,377,452

893,549

579,013

121,714

5,297

2,515

31,421

19

3,010,980

30.8

Severe

247,864

160,335

386,803

19,006

4,328

0

671

0

819,007

8.4

Total

4,513,820

2,151,261

2,356,352

455,494

104,834

38,070

162,424

315

9,782,570

100.0



Table 5.1: Uses of animals in all sub-categories of research and testing by severities (2015)

Non-recovery

Mild [up to and including]

Moderate

Severe

Total

%

Basic research

Oncology

16,863

205,653

241,475

52,413

516,404

5.3

Cardiovascular Blood and Lymphatic System

39,624

156,509

127,681

14,792

338,606

3.5

Nervous System

103,055

411,549

289,393

53,816

857,813

8.8

Respiratory System

4,852

30,596

46,781

3,549

85,778

0.9

Gastrointestinal System including Liver

36,535

95,497

67,130

8,871

208,033

2.1

Musculoskeletal System

6,569

52,664

29,437

4,000

92,670

0.9

Immune System

53,310

434,346

245,774

70,922

804,352

8.2

Urogenital/Reproductive System

11,677

96,984

25,900

3,396

137,957

1.4

Sensory Organs (skin, eyes and ears)

8,790

46,750

24,472

6,140

86,152

0.9

Endocrine System/Metabolism

27,929

118,434

60,363

2,402

209,128

2.1

Multisystemic

12,780

211,491

60,786

12,548

297,605

3

Ethology / Animal Behaviour /Animal Biology

7,084

534,729

57,298

6,128

605,239

6.2

Other basic research

20,753

143,481

100,962

8,887

274,083

2.8

Translational and applied research

Human Cancer

4,050

138,664

320,931

28,675

492,320

5

Human Infectious Disorders

16,479

116,281

107,722

41,720

282,202

2.9

Human Cardiovascular Disorders

11,671

23,742

20,640

6,110

62,163

0.6

Human Nervous and Mental Disorders

18,038

182,111

127,563

18,187

345,899

3.5

Human Respiratory Disorders

6,321

29,296

28,519

2,248

66,384

0.7

Human Gastrointestinal Disorders including Liver

2,072

13,139

14,729

2,270

32,210

0.3

Human Musculoskeletal Disorders

1,323

12,085

15,687

2,179

31,274

0.3

Human Immune Disorders

6,168

36,602

31,252

3,228

77,250

0.8

Human Urogenital/Reproductive Disorders

1,460

5,618

9,769

1,058

17,905

0.2

Human Sensory Organ Disorders (skin, eyes and ears)

2,543

24,547

18,001

1,295

46,386

0.5

Human Endocrine/Metabolism Disorders

6,910

54,770

59,587

2,546

123,813

1.3

Other Human Disorders

75,126

15,772

13,396

1,479

105,773

1.1

Animal Diseases and Disorders

20,537

110,959

69,339

22,978

223,813

2.3

Animal Welfare

999

70,921

6,422

173

78,515

0.8

Diagnosis of diseases

3,560

36,920

23,984

20,499

84,963

0.9

Plant diseases

0

455

24

1

480

0

Non-regulatory toxicology and ecotoxicology

4,876

43,362

25,984

5,689

79,911

0.8

Regulatory use

Quality control (incl batch safety and potency testing)

Batch safety testing

0

192,119

26,350

10,348

228,817

2.3

Pyrogenicity testing

923

28,448

17,178

4

46,553

0.5

Batch potency testing

8,757

407,504

310,422

305,552

1,032,235

10.6

Other quality controls

264

21,932

1,325

1,410

24,931

0.3

Toxicity and other safety testing including pharmacology

Acute and sub-acute toxicity testing methods

LD50, LC50

4,688

29,893

6,651

17,079

58,311

0.6

Other lethal methods

1,364

753

1,219

494

3,830

0

Non lethal methods

412

18,621

10,784

2,303

32,120

0.3

Skin irritation/corrosion

249

3,603

880

41

4,773

0

Skin sensitisation

3,218

42,305

3,482

544

49,549

0.5

Eye irritation/corrosion

269

523

681

45

1,518

0

Repeated dose toxicity

up to 28 days

1

45,957

25,616

2,118

73,692

0.8

29 - 90 days

0

20,121

7,224

678

28,023

0.3

> 90 days

884

9,690

7,010

611

18,195

0.2

Carcinogenicity

239

11,691

11,143

950

24,023

0.2

Genotoxicity

135

10,224

1,665

381

12,405

0.1

Reproductive toxicity

586

80,724

14,188

1,428

96,926

1

Developmental toxicity

724

99,384

11,244

1,674

113,026

1.2

Neurotoxicity

6

1,944

4,728

3,122

9,800

0.1

Kinetics

224

42,423

20,853

1,022

64,522

0.7

Pharmaco-dynamics (incl safety pharmacology)

1,073

65,901

37,813

5,977

110,764

1.1

Phototoxicity

0

468

122

6

596

0

Ecotoxicity

Acute toxicity

2,557

43,678

2,958

10,901

60,094

0.6

Chronic toxicity

0

13,956

4,000

2,205

20,161

0.2

Reproductive ecotoxicity

0

3,637

0

16

3,653

0

Endocrine activity

0

2,050

7,538

322

9,910

0.1

Bioaccumulation

0

2,058

886

6

2,950

0

Other ecotoxicity

0

8,195

21

161

8,377

0.1

Safety testing in food and feed area

0

24,702

90

10,931

35,723

0.4

Target animal safety

0

11,791

3,103

224

15,118

0.2

Other toxicity/safety testing

141

11,383

3,686

318

15,528

0.2

Other efficacy and tolerance testing

Other efficacy and tolerance testing

242

107,902

36,153

5,932

150,229

1.5

Routine production

Blood based products

762

178,344

90,831

1,456

271,393

2.8

Monoclonal antibody by mouse ascites method

0

2,027

11,633

13,673

27,333

0.3

Other product types

0

133,641

19,250

3,877

156,768

1.6

Other

Protection of the natural environment in the interests of the health or welfare of human beings or animals

10,597

84,612

5,297

4,328

104,834

1.1

Preservation of species

4,493

31,062

2,515

0

38,070

0.4

Higher education or training for the acquisition, maintenance or improvement of vocational skills

47,250

83,082

31,421

671

162,424

1.7

Forensic enquiries

22

274

19

0

315

0

Total

622,034

5,330,549

3,010,980

819,007

9,782,570

100

%

6.4

54.5

30.8

8.4

100



Table 6: Basic research related uses by species and type of research (2015)

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

%

Mammals

Rodents

Mice

481,130

264,604

619,288

64,378

104,835

65,104

730,529

92,982

68,536

140,699

211,768

23,914

138,847

3,006,614

66.6

Rats

8,219

38,373

157,662

17,464

12,094

8,302

12,199

12,845

6,200

19,790

12,405

12,477

11,156

329,186

7.3

Guinea-Pigs

72

396

350

1,664

247

0

222

37

856

0

354

80

237

4,515

0.1

Hamsters (Syrian)

466

4

275

0

75

0

169

0

0

520

4

28

236

1,777

0

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Mongolian gerbil

0

0

841

0

104

0

74

0

285

0

0

38

205

1,547

0

Other rodents

226

0

267

0

30

0

1,203

67

87

535

331

3,945

7,605

14,296

0.3

Rabbits

Rabbits

238

2,149

285

1,184

328

739

1,083

640

838

5,122

943

2,987

5,360

21,896

0.5

Carnivores

Cats

40

109

81

0

62

31

10

14

61

135

177

55

28

803

0

Dogs

16

54

180

4

98

339

4

75

35

42

270

156

82

1,355

0

Ferrets

0

0

244

18

0

0

0

0

20

0

0

6

56

344

0

Other carnivores

0

0

0

0

0

0

0

330

0

180

9

1,237

10

1,766

0

Farm animals

Horses, donkeys and cross-breeds

0

29

0

45

101

158

322

422

631

318

53

310

207

2,596

0.1

Pigs

179

1,796

531

556

7,094

430

1,418

845

241

1,195

1,265

7,016

2,333

24,899

0.6

Goats

0

22

2

0

55

0

39

138

0

30

53

259

324

922

0

Sheep

31

548

202

177

508

291

265

379

0

183

447

2,749

2,661

8,441

0.2

Cattle

16

239

52

41

934

0

965

3,113

0

1,398

2,341

6,014

678

15,791

0.3

Non-human primates

Prosimians

0

0

59

0

0

0

0

0

0

138

0

61

0

258

0

Marmoset and tamarins

0

0

87

42

0

38

0

54

0

0

52

0

0

273

0

Squirrel monkey

0

0

13

0

0

0

0

0

0

0

0

0

0

13

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

24

0

24

0

Cynomolgus monkey

4

0

101

0

0

6

15

0

0

5

1

4

4

140

0

Rhesus monkey

0

61

121

0

0

0

18

0

0

4

0

0

11

215

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

9

0

0

0

3

0

0

0

0

0

0

12

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

8

0

8

0

Other mammals

Other mammals

0

2

200

0

10

726

154

57

9

14

5

7,097

172

8,446

0.2

Birds

Domestic fowl

1,026

700

2,711

20

24,691

31

4,326

908

211

4,673

7,116

29,257

72,726

148,396

3.3

Other birds

24

593

470

0

780

52

1,897

132

14

446

4,060

38,279

5,245

51,992

1.2

Reptiles

Reptiles

0

45

332

30

0

0

0

0

0

0

4

2,896

53

3,360

0.1

Amphibians

Rana

800

0

0

0

0

0

0

0

10

0

0

482

0

1,292

0

Xenopus

437

371

2,990

0

328

45

0

2,021

719

664

858

284

7,206

15,923

0.4

Other amphibians

0

27

19

0

0

751

0

14

202

0

0

5,626

2,625

9,264

0.2

Fish

Zebra fish

20,341

28,026

67,207

54

922

15,578

24,086

15,808

7,057

11,823

29,073

6,051

12,565

238,591

5.3

Other fish

3,139

458

3,234

101

54,737

49

25,351

7,076

140

21,214

26,016

453,898

3,450

598,863

13.3

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

1

1

2

0

Totals

Total

516,404

338,606

857,813

85,778

208,033

92,670

804,352

137,957

86,152

209,128

297,605

605,239

274,083

4,513,820

100

%

11.4

7.5

19

1.9

4.6

2.1

17.8

3.1

1.9

4.6

6.6

13.4

6.1

100

Table 7.1: Translational and applied research related uses by species and type of research (Part 1) (2015)

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Mammals

Rodents

Mice

480,841

239,021

41,262

214,488

35,801

24,619

21,550

70,732

11,394

Rats

7,583

9,986

14,778

112,839

23,188

6,515

6,763

5,785

3,451

Guinea-Pigs

2

930

586

607

5,836

55

280

121

53

Hamsters (Syrian)

390

5,109

134

65

0

0

0

0

4

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

Mongolian gerbil

216

1,089

0

75

28

0

0

0

0

Other rodents

0

2,101

0

494

0

0

0

80

0

Rabbits

Rabbits

1,283

1,164

796

143

875

124

1,062

146

18

Carnivores

Cats

0

0

0

0

0

38

0

0

0

Dogs

54

36

97

747

98

29

86

43

6

Ferrets

0

885

0

0

0

64

0

0

0

Other carnivores

0

4

0

0

0

0

0

0

0

Farm animals

Horses, donkeys and cross-breeds

0

92

0

0

0

0

25

5

0

Pigs

250

108

2,728

203

417

704

110

274

391

Goats

11

0

18

5

0

0

111

0

7

Sheep

24

1,781

525

207

38

5

784

0

211

Cattle

0

113

39

0

46

0

0

0

16

Non-human primates

Prosimians

0

0

0

1

0

0

0

0

0

Marmoset and tamarins

0

4

0

38

0

0

0

4

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

3

479

38

129

57

57

5

49

1

Rhesus monkey

3

127

0

12

0

0

0

0

2

Vervets (Chlorocebus spp.)

0

4

0

0

0

0

0

0

0

Baboons

0

0

6

0

0

0

0

0

6

Other species of old world monkeys (Cercopithecoidea)

0

1

0

0

0

0

0

0

0

Other mammals

Other mammals

34

487

6

15

0

0

0

6

21

Birds

Domestic fowl

509

97

0

0

0

0

0

2

0

Other birds

0

6,502

0

0

0

0

0

3

0

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

Xenopus

0

0

44

25

0

0

0

0

0

Other amphibians

0

0

0

18

0

0

0

0

0

Fish

Zebra fish

1,113

12,082

1,106

15,788

0

0

498

0

2,324

Other fish

4

0

0

0

0

0

0

0

0

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

Totals

Total

492,320

282,202

62,163

345,899

66,384

32,210

31,274

77,250

17,905

%

22.9

13.1

2.9

16.1

3.1

1.5

1.5

3.6

0.8



Table 7.2: Translational and applied research related uses by species and type of research (Part 2) (2015)

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

%

Mammals

Rodents

Mice

38,408

79,739

73,176

44,132

4,092

46,755

6

17,020

1,443,036

67.1

Rats

6,095

41,142

15,021

1,549

723

4,665

419

22,798

283,300

13.2

Guinea-Pigs

403

18

13,705

1,934

243

1,080

0

161

26,014

1.2

Hamsters (Syrian)

0

682

218

790

0

78

0

11

7,481

0.3

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

0

Mongolian gerbil

12

0

0

1,704

0

0

0

62

3,186

0.1

Other rodents

0

0

0

145

0

0

0

70

2,890

0.1

Rabbits

Rabbits

1,006

115

1,315

5,968

10

862

44

1,117

16,048

0.7

Carnivores

Cats

0

0

0

1,028

8

36

0

5

1,115

0.1

Dogs

28

257

291

5,265

19

84

0

1,212

8,352

0.4

Ferrets

0

0

0

40

52

21

0

0

1,062

0

Other carnivores

0

0

0

346

532

0

0

0

882

0

Farm animals

Horses, donkeys and cross-breeds

0

0

0

731

264

100

0

0

1,217

0.1

Pigs

253

1,395

529

15,412

3,489

136

11

615

27,025

1.3

Goats

0

0

2

1,151

51

7

0

0

1,363

0.1

Sheep

10

0

2

4,508

332

895

0

32

9,354

0.4

Cattle

0

0

264

8,016

2,156

175

0

14

10,839

0.5

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

1

0

Marmoset and tamarins

0

14

12

0

0

0

0

17

89

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

32

55

1

0

0

0

0

291

1,197

0.1

Rhesus monkey

0

4

0

0

0

0

0

0

148

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

52

56

0

Baboons

0

0

0

0

0

0

0

18

30

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

1

0

Other mammals

Other mammals

0

17

0

490

45

619

0

0

1,740

0.1

Birds

Domestic fowl

0

0

271

63,761

19,857

1,825

0

375

86,697

4

Other birds

0

0

165

7,706

492

2,936

0

0

17,804

0.8

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

0

Xenopus

12

0

0

0

0

0

0

1,173

1,254

0.1

Other amphibians

0

0

15

24

7

0

0

0

64

0

Fish

Zebra fish

127

375

786

888

0

0

0

20,663

55,750

2.6

Other fish

0

0

0

58,217

30,303

24,689

0

14,205

127,418

5.9

Cephalopods

Cephalopods

0

0

0

8

15,840

0

0

0

15,848

0.7

Totals

Total

46,386

123,813

105,773

223,813

78,515

84,963

480

79,911

2,151,261

100

%

2.2

5.8

4.9

10.4

3.6

3.9

0

3.7

100



Table 8: Regulatory uses by species and type of use (2015)

Quality

Toxicity

Other

Quality: Batch safety testing

Quality: Pyrogenicity testing

Quality: Batch potency testing

Quality: Other quality controls

Toxicity and other safety testing including pharmacology

Other efficacy and tolerance testing

Total

%

Mammals

Rodents

Mice

131,742

10

715,180

17,685

257,936

78,016

1,200,569

51

Rats

14,935

0

147,981

1,573

388,116

6,476

559,081

23.7

Guinea-Pigs

20,617

0

62,455

1,202

30,923

596

115,793

4.9

Hamsters (Syrian)

2,025

0

5,326

352

1,259

1,728

10,690

0.5

Hamsters (Chinese)

0

0

0

0

30

0

30

0

Mongolian gerbil

0

0

0

0

1,581

24

1,605

0.1

Other rodents

67

0

0

0

8,370

0

8,437

0.4

Rabbits

Rabbits

3,375

46,543

19,762

235

30,692

2,414

103,021

4.4

Carnivores

Cats

145

0

103

0

723

229

1,200

0.1

Dogs

285

0

17

0

9,877

1,057

11,236

0.5

Ferrets

621

0

0

0

171

47

839

0

Other carnivores

556

0

0

0

142

144

842

0

Farm animals

Horses, donkeys and cross-breeds

9

0

4

0

47

93

153

0

Pigs

2,621

0

2,177

109

4,285

5,727

14,919

0.6

Goats

6

0

48

0

67

0

121

0

Sheep

608

0

567

21

683

102

1,981

0.1

Cattle

297

0

1,584

6

769

1,324

3,980

0.2

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

0

0

162

0

162

0

Squirrel monkey

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

Cynomolgus monkey

18

0

0

0

5,954

3

5,975

0.3

Rhesus monkey

0

0

0

0

23

31

54

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

77

63

140

0

Birds

Domestic fowl

48,806

0

72,451

3,046

16,511

27,647

168,461

7.1

Other birds

1,884

0

547

180

2,585

1,098

6,294

0.3

Reptiles

Reptiles

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

132

0

132

0

Xenopus

0

0

0

0

720

0

720

0

Other amphibians

0

0

0

0

60

0

60

0

Fish

Zebra fish

0

0

0

86

42,979

0

43,065

1.8

Other fish

200

0

4,033

436

68,713

23,410

96,792

4.1

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

Totals

Total

228,817

46,553

1,032,235

24,931

873,587

150,229

2,356,352

100

%

9.7

2

43.8

1.1

37.1

6.4

100



Table 9.1: Toxicity and other safety testing including pharmacology by species and type of use (Part 1) (2015)

Acute

Repeated Dose

LD50, LC50

Other lethal methods

Non lethal methods

Skin irritation / corrosion

Skin sensitisation

Eye irritation / corrosion

up to 28 days

29 - 90 days

> 90 days

Carcinogenicity

Genotoxicity

Developmental toxicity

Safety testing in food and feed area

Mammals

Rodents

Mice

39,713

1,671

13,492

0

21,683

0

22,683

3,722

2,159

9,083

6,165

644

33,105

Rats

6,638

1,168

12,846

400

69

49

44,025

21,197

12,227

14,940

6,148

104,091

0

Guinea-Pigs

342

0

1,373

19

27,653

22

0

0

0

0

0

0

0

Hamsters (Syrian)

0

0

334

139

7

0

395

0

200

0

4

0

0

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

0

30

0

0

Mongolian gerbil

0

0

0

0

0

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

0

1,165

4,182

129

1,447

1,310

740

224

0

58

6,961

32

Carnivores

Cats

0

0

0

0

0

0

0

9

0

0

0

0

0

Dogs

0

0

671

0

0

0

2,993

1,211

1,431

0

0

14

38

Ferrets

0

0

0

0

0

0

146

0

0

0

0

0

0

Other carnivores

58

0

0

0

0

0

0

0

0

0

0

0

0

Farm animals

Horses, donkeys and cross-breeds

0

0

0

0

0

0

0

0

0

0

0

0

0

Pigs

0

0

147

33

8

0

716

376

369

0

0

0

91

Goats

0

0

0

0

0

0

0

0

0

0

0

0

0

Sheep

0

0

0

0

0

0

0

0

0

0

0

0

344

Cattle

0

0

0

0

0

0

0

0

0

0

0

0

176

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

0

0

0

0

0

6

36

0

0

0

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

128

0

0

0

1,421

762

1,549

0

0

113

0

Rhesus monkey

0

0

0

0

0

0

3

0

0

0

0

0

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

3,570

0

0

0

0

0

0

0

0

0

0

0

1,505

Other birds

80

0

40

0

0

0

0

0

0

0

0

0

0

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

0

0

0

0

Xenopus

0

0

0

0

0

0

0

0

0

0

0

0

0

Other amphibians

0

0

0

0

0

0

0

0

0

0

0

0

0

Fish

Zebra fish

2,101

991

1,579

0

0

0

0

0

0

0

0

800

0

Other fish

5,809

0

345

0

0

0

0

0

0

0

0

403

432

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

58,311

3,830

32,120

4,773

49,549

1,518

73,692

28,023

18,195

24,023

12,405

113,026

35,723

%

6.7

0.4

3.7

0.5

5.7

0.2

8.5

3.2

2.1

2.8

1.4

13

4.1

Table 9.2: Toxicity and other safety testing including pharmacology by species and type of use (Part 2) (2015)

EcoToxicity

Target animal safety

Neurotoxicity

Kinetics

Pharmaco - dynamics (incl safety pharmacology)

Phototoxicity

Acute toxicity

Chronic toxicity

Reproductive toxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Other toxicity / safety testing

Total

%

Mammals

Rodents

Mice

632

484

29,729

60,090

420

6,495

81

160

0

0

0

5,725

257,936

29.7

Rats

60

916

27,815

42,105

112

1,864

896

85,462

0

58

0

5,030

388,116

44.6

Guinea-Pigs

0

0

102

1,111

64

137

0

0

0

0

0

100

30,923

3.6

Hamsters (Syrian)

0

0

23

100

0

0

0

0

0

0

0

57

1,259

0.1

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

0

0

0

30

0

Mongolian gerbil

0

0

0

1,581

0

0

0

0

0

0

0

0

1,581

0.2

Other rodents

314

0

0

0

0

0

0

0

0

0

5,201

2,855

8,370

1

Rabbits

Rabbits

38

0

838

2,097

0

27

0

11,104

0

0

0

340

30,692

3.5

Carnivores

Cats

155

0

437

78

0

0

0

0

0

18

0

26

723

0.1

Dogs

173

0

2,066

942

0

0

0

0

0

0

0

338

9,877

1.1

Ferrets

0

0

0

25

0

0

0

0

0

0

0

0

171

0

Other carnivores

84

0

0

0

0

0

0

0

0

0

0

0

142

0

Farm animals

Horses, donkeys and cross-breeds

28

0

19

0

0

0

0

0

0

0

0

0

47

0

Pigs

871

0

1,072

352

0

0

0

9

0

0

6

235

4,285

0.5

Goats

0

0

66

0

0

0

0

0

0

0

0

1

67

0

Sheep

20

0

242

21

0

0

0

0

0

0

0

56

683

0.1

Cattle

23

0

355

20

0

0

0

0

0

0

0

195

769

0.1

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

37

22

0

0

0

0

0

0

0

61

162

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

1,013

298

0

0

0

191

0

0

0

479

5,954

0.7

Rhesus monkey

0

0

20

0

0

0

0

0

0

0

0

0

23

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

77

0

0

0

0

0

0

0

0

0

0

0

77

0

Birds

Domestic fowl

10,781

0

610

0

0

15

0

0

0

0

0

30

16,511

1.9

Other birds

312

0

78

0

0

1,125

0

0

0

0

154

0

1,789

0.2

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

132

0

0

0

0

0

0

132

0

Xenopus

0

0

0

0

0

0

0

0

720

0

0

0

720

0.1

Other amphibians

0

0

0

0

0

0

60

0

0

0

0

0

60

0

Fish

Zebra fish

120

8,400

0

1,410

0

7,246

8,362

0

8,210

591

812

0

40,622

4.7

Other fish

1,430

0

0

512

0

43,053

10,762

0

980

2,283

2,204

0

68,213

7.8

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

15,118

9,800

64,522

110,764

596

60,094

20,161

96,926

9,910

2,950

8,377

15,528

869,934

100

%

1.7

1.1

7.4

12.7

0.1

6.9

2.3

11.1

1.1

0.3

1

1.8

100

Table 10: Regulatory uses by species and type of legislation (2015)

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Other legislation

Total

%

Mammals

Rodents

Mice

988,107

124,591

16,001

13,014

10,086

1,966

41,099

3,683

2,022

1,200,569

51

Rats

349,497

12,869

3,976

152,321

31,060

1,488

4,564

223

3,083

559,081

23.7

Guinea-Pigs

73,760

16,106

21,660

2,432

1,412

105

38

0

280

115,793

4.9

Hamsters (Syrian)

1,212

8,866

591

10

0

0

0

0

11

10,690

0.5

Hamsters (Chinese)

0

0

0

30

0

0

0

0

0

30

0

Mongolian gerbil

35

1,570

0

0

0

0

0

0

0

1,605

0.1

Other rodents

67

0

0

0

8,370

0

0

0

0

8,437

0.4

Rabbits

Rabbits

71,027

14,746

4,527

9,792

1,390

86

35

4

1,414

103,021

4.4

Carnivores

Cats

58

1,142

0

0

0

0

0

0

0

1,200

0.1

Dogs

8,843

1,906

32

60

158

0

0

12

225

11,236

0.5

Ferrets

792

47

0

0

0

0

0

0

0

839

0

Other carnivores

0

818

0

0

0

0

0

0

24

842

0

Farm animals

Horses, donkeys and cross-breeds

8

121

0

0

0

0

0

0

24

153

0

Pigs

3,339

10,169

297

0

1

0

98

967

48

14,919

0.6

Goats

52

51

0

0

18

0

0

0

0

121

0

Sheep

13

1,385

172

0

0

0

338

16

57

1,981

0.1

Cattle

0

3,303

0

0

123

0

0

406

148

3,980

0.2

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

162

0

0

0

0

0

0

0

0

162

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

5,962

0

0

0

0

0

0

0

13

5,975

0.3

Rhesus monkey

54

0

0

0

0

0

0

0

0

54

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

140

0

0

0

0

0

0

0

140

0

Birds

Domestic fowl

1,547

157,170

0

0

525

0

160

9,059

0

168,461

7.1

Other birds

80

3,082

0

24

2,091

0

57

960

0

6,294

0.3

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

132

0

0

0

0

132

0

Xenopus

0

0

0

0

0

0

0

0

720

720

0

Other amphibians

0

0

0

0

60

0

0

0

0

60

0

Fish

Zebra fish

7,946

2,511

0

7,122

4,442

1,109

0

1,512

18,423

43,065

1.8

Other fish

5,562

7,978

14

11,145

12,216

142

953

23,410

35,372

96,792

4.1

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

1,518,123

368,571

47,270

195,950

72,084

4,896

47,342

40,252

61,864

2,356,352

100

%

64.4

15.6

2

8.3

3.1

0.2

2

1.7

2.6

100

Table 11: Regulatory uses by species and origin of regulatory requirement (2015)

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

%

Mammals

Rodents

Mice

1,128,543

21,105

50,921

1,200,569

51

Rats

548,222

1,121

9,738

559,081

23.7

Guinea-Pigs

105,812

0

9,981

115,793

4.9

Hamsters (Syrian)

10,353

157

180

10,690

0.5

Hamsters (Chinese)

30

0

0

30

0

Mongolian gerbil

1,605

0

0

1,605

0.1

Other rodents

8,437

0

0

8,437

0.4

Rabbits

Rabbits

90,220

15

12,786

103,021

4.4

Carnivores

Cats

1,198

0

2

1,200

0.1

Dogs

11,183

13

40

11,236

0.5

Ferrets

839

0

0

839

0

Other carnivores

818

24

0

842

0

Farm animals

Horses, donkeys and cross-breeds

153

0

0

153

0

Pigs

13,607

69

1,243

14,919

0.6

Goats

121

0

0

121

0

Sheep

1,974

1

6

1,981

0.1

Cattle

3,966

2

12

3,980

0.2

Non-human primates

Prosimians

0

0

0

0

0

Marmoset and tamarins

162

0

0

162

0

Squirrel monkey

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

Cynomolgus monkey

5,963

0

12

5,975

0.3

Rhesus monkey

54

0

0

54

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

Baboons

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

Other mammals

Other mammals

140

0

0

140

0

Birds

Domestic fowl

162,369

341

5,751

168,461

7.1

Other birds

6,072

206

16

6,294

0.3

Reptiles

Reptiles

0

0

0

0

0

Amphibians

Rana

132

0

0

132

0

Xenopus

720

0

0

720

0

Other amphibians

60

0

0

60

0

Fish

Zebra fish

39,955

3,110

0

43,065

1.8

Other fish

79,909

15,410

1,473

96,792

4.1

Cephalopods

Cephalopods

0

0

0

0

0

Totals

Total

2,222,617

41,574

92,161

2,356,352

100

%

94.3

1.8

3.9

100



Table 12: Routine production uses by species and product type (2015)

Blood based products

Other product types

Monoclonal antibody by mouse ascites method

Total

%

Mammals

Rodents

Mice

2,955

3,660

27,067

33,682

7.4

Rats

1,161

263

26

1,450

0.3

Guinea-Pigs

1,397

33

0

1,430

0.3

Hamsters (Syrian)

180

0

0

180

0

Hamsters (Chinese)

0

0

0

0

0

Mongolian gerbil

19

167

0

186

0

Other rodents

38

0

0

38

0

Rabbits

Rabbits

174,320

43,372

240

217,932

47.8

Carnivores

Cats

0

18

0

18

0

Dogs

239

0

0

239

0.1

Ferrets

6

0

0

6

0

Other carnivores

2

0

0

2

0

Farm animals

Horses, donkeys and cross-breeds

7,760

18

0

7,778

1.7

Pigs

34

257

0

291

0.1

Goats

27

0

0

27

0

Sheep

39,517

1,542

0

41,059

9

Cattle

8

145

0

153

0

Non-human primates

Prosimians

0

0

0

0

0

Marmoset and tamarins

84

0

0

84

0

Squirrel monkey

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

Cynomolgus monkey

2,036

28

0

2,064

0.5

Rhesus monkey

32

0

0

32

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

Baboons

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

Other mammals

Other mammals

31

15

0

46

0

Birds

Domestic fowl

497

106,423

0

106,920

23.5

Other birds

41,050

502

0

41,552

9.1

Reptiles

Reptiles

0

300

0

300

0.1

Amphibians

Rana

0

0

0

0

0

Xenopus

0

0

0

0

0

Other amphibians

0

0

0

0

0

Fish

Zebra fish

0

0

0

0

0

Other fish

0

25

0

25

0

Cephalopods

Cephalopods

0

0

0

0

0

Totals

Total

271,393

156,768

27,333

455,494

100

%

59.6

34.4

6

100



Table 13: Reuses of animals by species and main categories of scientific purposes in research, testing routine production and education (2015)

Reuse

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Yes

16,924

11,745

19,717

72

2

1,840

4,892

0

55,192

1.0

No

2,989,690

1,431,291

1,180,852

33,610

3,619

4,878

67,632

40

5,711,612

99.0

Total

3,006,614

1,443,036

1,200,569

33,682

3,621

6,718

72,524

40

5,766,804

100.0

Rats

Yes

3,592

5,596

3,347

169

0

0

2,645

30

15,379

1.3

No

325,594

277,704

555,734

1,281

1,151

159

39,495

71

1,201,189

98.7

Total

329,186

283,300

559,081

1,450

1,151

159

42,140

101

1,216,568

100.0

Guinea-Pigs

Yes

19

71

469

28

0

0

229

0

816

0.5

No

4,496

25,943

115,324

1,402

0

0

2,127

36

149,328

99.5

Total

4,515

26,014

115,793

1,430

0

0

2,356

36

150,144

100.0

Hamsters (Syrian)

Yes

28

0

0

0

0

0

16

0

44

0.2

No

1,749

7,481

10,690

180

0

0

95

0

20,195

99.8

Total

1,777

7,481

10,690

180

0

0

111

0

20,239

100.0

Hamsters (Chinese)

Yes

0

0

0

0

0

0

0

0

0

0.0

No

0

0

30

0

0

0

0

0

30

100.0

Total

0

0

30

0

0

0

0

0

30

100.0

Mongolian gerbil

Yes

145

259

0

0

0

0

0

0

404

6.1

No

1,402

2,927

1,605

186

0

0

79

0

6,199

93.9

Total

1,547

3,186

1,605

186

0

0

79

0

6,603

100.0

Other rodents

Yes

757

0

0

0

22

0

16

0

795

3.0

No

13,539

2,890

8,437

38

625

315

244

0

26,088

97.0

Total

14,296

2,890

8,437

38

647

315

260

0

26,883

100.0

Rabbits

Yes

441

895

12,477

1,004

12

0

321

0

15,150

4.2

No

21,455

15,153

90,544

216,928

225

0

1,747

0

346,052

95.8

Total

21,896

16,048

103,021

217,932

237

0

2,068

0

361,202

100.0

Cats

Yes

282

389

492

0

0

0

47

0

1,210

38.0

No

521

726

708

18

0

0

2

0

1,975

62.0

Total

803

1,115

1,200

18

0

0

49

0

3,185

100.0

Dogs

Yes

460

3,163

2,971

231

6

0

407

0

7,238

33.3

No

895

5,189

8,265

8

6

0

138

0

14,501

66.7

Total

1,355

8,352

11,236

239

12

0

545

0

21,739

100.0

Ferrets

Yes

15

46

0

0

0

0

79

0

140

6.0

No

329

1,016

839

6

0

0

22

0

2,212

94.0

Total

344

1,062

839

6

0

0

101

0

2,352

100.0

Other carnivores

Yes

36

0

24

2

0

14

0

0

76

2.0

No

1,730

882

818

0

170

48

0

0

3,648

98.0

Total

1,766

882

842

2

170

62

0

0

3,724

100.0

Horses, donkeys and cross-breeds

Yes

555

370

46

7,679

1

34

166

0

8,851

73.3

No

2,041

847

107

99

0

0

123

0

3,217

26.7

Total

2,596

1,217

153

7,778

1

34

289

0

12,068

100.0

Pigs

Yes

658

1,314

507

1

8

3

1,014

0

3,505

4.5

No

24,241

25,711

14,412

290

780

0

8,461

0

73,895

95.5

Total

24,899

27,025

14,919

291

788

3

9,475

0

77,400

100.0

Goats

Yes

235

8

0

3

0

0

162

0

408

15.4

No

687

1,355

121

24

10

0

36

0

2,233

84.6

Total

922

1,363

121

27

10

0

198

0

2,641

100.0

Sheep

Yes

1,446

1,344

264

39,249

53

62

342

0

42,760

68.0

No

6,995

8,010

1,717

1,810

319

0

1,134

121

20,106

32.0

Total

8,441

9,354

1,981

41,059

372

62

1,476

121

62,866

100.0

Cattle

Yes

4,128

1,309

592

2

17

0

3,546

0

9,594

26.4

No

11,663

9,530

3,388

151

709

0

1,316

6

26,763

73.6

Total

15,791

10,839

3,980

153

726

0

4,862

6

36,357

100.0

Prosimians

Yes

90

0

0

0

0

0

0

0

90

34.7

No

168

1

0

0

0

0

0

0

169

65.3

Total

258

1

0

0

0

0

0

0

259

100.0

Marmoset and tamarins

Yes

26

9

60

84

0

0

6

0

185

30.1

No

247

80

102

0

0

0

0

0

429

69.9

Total

273

89

162

84

0

0

6

0

614

100.0

Squirrel monkey

Yes

0

0

0

0

0

0

0

0

0

0.0

No

13

0

0

0

0

0

0

0

13

100.0

Total

13

0

0

0

0

0

0

0

13

100.0

Other species of new world monkeys (Ceboidea)

Yes

24

0

0

0

0

0

0

0

24

100.0

No

0

0

0

0

0

0

0

0

0

0.0

Total

24

0

0

0

0

0

0

0

24

100.0

Cynomolgus monkey

Yes

53

434

1,498

1,170

0

0

23

0

3,178

33.8

No

87

763

4,477

894

0

0

0

0

6,221

66.2

Total

140

1,197

5,975

2,064

0

0

23

0

9,399

100.0

Rhesus monkey

Yes

125

30

51

32

0

0

5

0

243

53.5

No

90

118

3

0

0

0

0

0

211

46.5

Total

215

148

54

32

0

0

5

0

454

100.0

Vervets (Chlorocebus spp.)

Yes

0

0

0

0

0

0

0

0

0

0.0

No

0

56

0

0

0

0

0

0

56

100.0

Total

0

56

0

0

0

0

0

0

56

100.0

Baboons

Yes

3

2

0

0

0

0

0

0

5

11.9

No

9

28

0

0

0

0

0

0

37

88.1

Total

12

30

0

0

0

0

0

0

42

100.0

Other species of old world monkeys (Cercopithecoidea)

Yes

8

1

0

0

0

0

0

0

9

100.0

No

0

0

0

0

0

0

0

0

0

0.0

Total

8

1

0

0

0

0

0

0

9

100.0

Other mammals

Yes

1,206

453

0

0

0

0

0

0

1,659

14.8

No

7,240

1,287

140

46

544

205

73

0

9,535

85.2

Total

8,446

1,740

140

46

544

205

73

0

11,194

100.0

Domestic fowl

Yes

688

812

2,030

173

253

0

1,362

0

5,318

1.0

No

147,708

85,885

166,431

106,747

2,324

939

5,800

0

515,834

99.0

Total

148,396

86,697

168,461

106,920

2,577

939

7,162

0

521,152

100.0

Other birds

Yes

1,213

354

236

0

4

0

460

0

2,267

1.9

No

50,779

17,450

6,058

41,552

2,737

624

166

11

119,377

98.1

Total

51,992

17,804

6,294

41,552

2,741

624

626

11

121,644

100.0

Reptiles

Yes

1,099

0

0

300

0

0

19

0

1,418

37.0

No

2,261

0

0

0

93

46

14

0

2,414

63.0

Total

3,360

0

0

300

93

46

33

0

3,832

100.0

Rana

Yes

0

0

0

0

0

0

0

0

0

0.0

No

1,292

0

132

0

600

0

2,860

0

4,884

100.0

Total

1,292

0

132

0

600

0

2,860

0

4,884

100.0

Xenopus

Yes

7,443

694

0

0

0

0

16

0

8,153

42.9

No

8,480

560

720

0

848

0

229

0

10,837

57.1

Total

15,923

1,254

720

0

848

0

245

0

18,990

100.0

Other amphibians

Yes

115

9

0

0

120

0

0

0

244

1.2

No

9,149

55

60

0

6,782

3,893

251

0

20,190

98.8

Total

9,264

64

60

0

6,902

3,893

251

0

20,434

100.0

Zebra fish

Yes

4,450

0

0

0

0

0

0

0

4,450

1.3

No

234,141

55,750

43,065

0

4,220

0

1,639

0

338,815

98.7

Total

238,591

55,750

43,065

0

4,220

0

1,639

0

343,265

100.0

Other fish

Yes

3,337

0

0

0

0

0

49

0

3,386

0.4

No

595,526

127,418

96,792

25

78,574

25,010

12,907

0

936,252

99.6

Total

598,863

127,418

96,792

25

78,574

25,010

12,956

0

939,638

100.0

Cephalopods

Yes

0

0

0

0

0

0

0

0

0

0.0

No

2

15,848

0

0

0

0

12

0

15,862

100.0

Total

2

15,848

0

0

0

0

12

0

15,862

100.0

All Species

Yes

49,601

29,307

44,781

50,199

498

1,953

15,822

30

192,191

2.0

No

4,464,219

2,121,954

2,311,571

405,295

104,336

36,117

146,602

285

9,590,379

98.0

Total

4,513,820

2,151,261

2,356,352

455,494

104,834

38,070

162,424

315

9,782,570

100.0

Table 14: Genetic status of animals used by species and main categories of scientific purposes (2015)

Genetic status

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Not altered

1,341,777

991,245

1,152,221

33,666

3,621

583

66,939

4

3,590,056

62.3

Non harmful

1,411,193

331,031

46,407

16

0

6,063

5,059

0

1,799,769

31.2

Harmful

253,644

120,760

1,941

0

0

72

526

36

376,979

6.5

Total

3,006,614

1,443,036

1,200,569

33,682

3,621

6,718

72,524

40

5,766,804

100.0

Rats

Not altered

310,741

274,782

555,923

1,450

1,151

159

41,984

101

1,186,291

97.5

Non harmful

14,917

3,755

3,024

0

0

0

120

0

21,816

1.8

Harmful

3,528

4,763

134

0

0

0

36

0

8,461

0.7

Total

329,186

283,300

559,081

1,450

1,151

159

42,140

101

1,216,568

100.0

Guinea-Pigs

Not altered

4,515

25,923

115,793

1,430

0

0

2,356

36

150,053

99.9

Non harmful

0

91

0

0

0

0

0

0

91

0.1

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

4,515

26,014

115,793

1,430

0

0

2,356

36

150,144

100.0

Hamsters (Syrian)

Not altered

1,777

7,481

10,690

180

0

0

111

0

20,239

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,777

7,481

10,690

180

0

0

111

0

20,239

100.0

Hamsters (Chinese)

Not altered

0

0

30

0

0

0

0

0

30

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

30

0

0

0

0

0

30

100.0

Mongolian gerbil

Not altered

1,547

3,186

1,605

186

0

0

79

0

6,603

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,547

3,186

1,605

186

0

0

79

0

6,603

100.0

Other rodents

Not altered

14,296

2,890

8,437

38

647

315

260

0

26,883

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

14,296

2,890

8,437

38

647

315

260

0

26,883

100.0

Rabbits

Not altered

21,851

15,968

103,021

180,133

237

0

2,067

0

323,277

89.5

Non harmful

22

34

0

37,799

0

0

0

0

37,855

10.5

Harmful

23

46

0

0

0

0

1

0

70

0.0

Total

21,896

16,048

103,021

217,932

237

0

2,068

0

361,202

100.0

Cats

Not altered

803

1,115

1,200

18

0

0

49

0

3,185

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

803

1,115

1,200

18

0

0

49

0

3,185

100.0

Dogs

Not altered

1,338

8,350

11,236

239

12

0

545

0

21,720

99.9

Non harmful

8

0

0

0

0

0

0

0

8

0.0

Harmful

9

2

0

0

0

0

0

0

11

0.1

Total

1,355

8,352

11,236

239

12

0

545

0

21,739

100.0

Ferrets

Not altered

344

1,062

839

6

0

0

101

0

2,352

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

344

1,062

839

6

0

0

101

0

2,352

100.0

Other carnivores

Not altered

1,766

882

842

2

170

62

0

0

3,724

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,766

882

842

2

170

62

0

0

3,724

100.0

Horses, donkeys and cross-breeds

Not altered

2,596

1,217

153

7,778

1

34

289

0

12,068

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

2,596

1,217

153

7,778

1

34

289

0

12,068

100.0

Pigs

Not altered

24,821

26,759

14,919

291

788

3

9,475

0

77,056

99.6

Non harmful

48

135

0

0

0

0

0

0

183

0.2

Harmful

30

131

0

0

0

0

0

0

161

0.2

Total

24,899

27,025

14,919

291

788

3

9,475

0

77,400

100.0

Goats

Not altered

922

1,363

121

27

10

0

198

0

2,641

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

922

1,363

121

27

10

0

198

0

2,641

100.0

Sheep

Not altered

8,434

9,354

1,981

41,059

372

62

1,476

121

62,859

100.0

Non harmful

7

0

0

0

0

0

0

0

7

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

8,441

9,354

1,981

41,059

372

62

1,476

121

62,866

100.0

Cattle

Not altered

15,790

10,839

3,980

153

726

0

4,862

6

36,356

100.0

Non harmful

1

0

0

0

0

0

0

0

1

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

15,791

10,839

3,980

153

726

0

4,862

6

36,357

100.0

Prosimians

Not altered

258

1

0

0

0

0

0

0

259

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

258

1

0

0

0

0

0

0

259

100.0

Marmoset and tamarins

Not altered

273

89

162

84

0

0

6

0

614

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

273

89

162

84

0

0

6

0

614

100.0

Squirrel monkey

Not altered

13

0

0

0

0

0

0

0

13

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

13

0

0

0

0

0

0

0

13

100.0

Other species of new world monkeys (Ceboidea)

Not altered

24

0

0

0

0

0

0

0

24

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

24

0

0

0

0

0

0

0

24

100.0

Cynomolgus monkey

Not altered

140

1,197

5,975

2,064

0

0

23

0

9,399

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

140

1,197

5,975

2,064

0

0

23

0

9,399

100.0

Rhesus monkey

Not altered

215

148

54

32

0

0

5

0

454

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

215

148

54

32

0

0

5

0

454

100.0

Vervets (Chlorocebus spp.)

Not altered

0

56

0

0

0

0

0

0

56

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

0

56

0

0

0

0

0

0

56

100.0

Baboons

Not altered

12

30

0

0

0

0

0

0

42

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

12

30

0

0

0

0

0

0

42

100.0

Other species of old world monkeys (Cercopithecoidea)

Not altered

8

1

0

0

0

0

0

0

9

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

8

1

0

0

0

0

0

0

9

100.0

Other mammals

Not altered

8,446

1,740

140

46

544

205

73

0

11,194

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

8,446

1,740

140

46

544

205

73

0

11,194

100.0

Domestic fowl

Not altered

148,143

86,678

168,461

106,920

2,577

939

7,162

0

520,880

99.9

Non harmful

139

19

0

0

0

0

0

0

158

0.0

Harmful

114

0

0

0

0

0

0

0

114

0.0

Total

148,396

86,697

168,461

106,920

2,577

939

7,162

0

521,152

100.0

Other birds

Not altered

51,992

17,804

6,294

41,552

2,741

624

626

11

121,644

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

51,992

17,804

6,294

41,552

2,741

624

626

11

121,644

100.0

Reptiles

Not altered

3,360

0

0

300

93

46

33

0

3,832

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

3,360

0

0

300

93

46

33

0

3,832

100.0

Rana

Not altered

1,292

0

132

0

600

0

2,860

0

4,884

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,292

0

132

0

600

0

2,860

0

4,884

100.0

Xenopus

Not altered

14,326

1,163

720

0

848

0

245

0

17,302

91.1

Non harmful

1,597

91

0

0

0

0

0

0

1,688

8.9

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

15,923

1,254

720

0

848

0

245

0

18,990

100.0

Other amphibians

Not altered

9,143

64

60

0

6,902

3,893

251

0

20,313

99.4

Non harmful

121

0

0

0

0

0

0

0

121

0.6

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

9,264

64

60

0

6,902

3,893

251

0

20,434

100.0

Zebra fish

Not altered

92,424

24,740

42,465

0

1,758

0

1,381

0

162,768

47.4

Non harmful

135,171

30,883

600

0

2,462

0

258

0

169,374

49.3

Harmful

10,996

127

0

0

0

0

0

0

11,123

3.2

Total

238,591

55,750

43,065

0

4,220

0

1,639

0

343,265

100.0

Other fish

Not altered

595,637

122,491

96,792

25

78,574

25,010

12,956

0

931,485

99.1

Non harmful

2,620

4,927

0

0

0

0

0

0

7,547

0.8

Harmful

606

0

0

0

0

0

0

0

606

0.1

Total

598,863

127,418

96,792

25

78,574

25,010

12,956

0

939,638

100.0

Cephalopods

Not altered

2

15,848

0

0

0

0

12

0

15,862

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

2

15,848

0

0

0

0

12

0

15,862

100.0

All Species

Harmful

268,950

125,829

2,075

0

0

72

563

36

397,525

4.1

Non harmful

1,565,844

370,966

50,031

37,815

2,462

6,063

5,437

0

2,038,618

20.8

Not altered

2,679,026

1,654,466

2,304,246

417,679

102,372

31,935

156,424

279

7,346,427

75.1

Total

4,513,820

2,151,261

2,356,352

455,494

104,834

38,070

162,424

315

9,782,570

100.0



Part 3: Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU



Table 15: Use of animals for the creation of new genetically altered animal lines by research type species and severity (2015)

Severity

Basic research

Translational and applied research

Total

%

Mice

Non-recovery

12,455

3,643

16,098

3.4

Mild

382,665

13,727

396,392

83.0

Moderate

52,476

9,094

61,570

12.9

Severe

2,949

774

3,723

0.8

Total

450,545

27,238

477,783

100.0

Rats

Non-recovery

146

0

146

3.3

Mild

1,363

438

1,801

41.1

Moderate

1,895

264

2,159

49.3

Severe

275

0

275

6.3

Total

3,679

702

4,381

100.0

Rabbits

Non-recovery

90

0

90

33.1

Mild

0

0

0

0.0

Moderate

101

81

182

66.9

Severe

0

0

0

0.0

Total

191

81

272

100.0

Pigs

Non-recovery

0

14

14

4.0

Mild

138

12

150

42.9

Moderate

166

0

166

47.4

Severe

20

0

20

5.7

Total

324

26

350

100.0

Sheep

Non-recovery

0

0

0

0.0

Mild

15

0

15

48.4

Moderate

16

0

16

51.6

Severe

0

0

0

0.0

Total

31

0

31

100.0

Other mammals

Non-recovery

0

0

0

0.0

Mild

0

0

0

0.0

Moderate

4

0

4

100.0

Severe

0

0

0

0.0

Total

4

0

4

100.0

Domestic fowl

Non-recovery

0

0

0

0.0

Mild

177

102

279

100.0

Moderate

0

0

0

0.0

Severe

0

0

0

0.0

Total

177

102

279

100.0

Xenopus

Non-recovery

0

0

0

0.0

Mild

6,976

0

6,976

96.1

Moderate

283

0

283

3.9

Severe

0

0

0

0.0

Total

7,259

0

7,259

100.0

Zebra fish

Non-recovery

657

0

657

0.5

Mild

104,439

1,512

105,951

85.2

Moderate

12,584

130

12,714

10.2

Severe

4,724

313

5,037

4.1

Total

122,404

1,955

124,359

100.0

Other fish

Non-recovery

26

0

26

1.0

Mild

2,516

0

2,516

98.4

Moderate

14

0

14

0.5

Severe

0

0

0

0.0

Total

2,556

0

2,556

100.0

All Species

Non-recovery

13,374

3,657

17,031

2.8

Mild

498,289

15,791

514,080

83.3

Moderate

67,539

9,569

77,108

12.5

Severe

7,968

1,087

9,055

1.5

Total

587,170

30,104

617,274

100.0

Table 16: Use of animals for the creation of new genetically altered animal lines by research type species and severity (2015)

Reuse

Basic research

Translational and applied research

Total

%

Mice

Yes

1,864

151

2,015

0.4

No

448,681

27,087

475,768

99.6

Total

450,545

27,238

477,783

100.0

Rats

Yes

0

0

0

0.0

No

3,679

702

4,381

100.0

Total

3,679

702

4,381

100.0

Rabbits

Yes

0

0

0

0.0

No

191

81

272

100.0

Total

191

81

272

100.0

Pigs

Yes

5

0

5

1.4

No

319

26

345

98.6

Total

324

26

350

100.0

Sheep

Yes

0

0

0

0.0

No

31

0

31

100.0

Total

31

0

31

100.0

Other mammals

Yes

0

0

0

0.0

No

4

0

4

100.0

Total

4

0

4

100.0

Domestic fowl

Yes

0

0

0

0.0

No

177

102

279

100.0

Total

177

102

279

100.0

Xenopus

Yes

5

0

5

0.1

No

7,254

0

7,254

99.9

Total

7,259

0

7,259

100.0

Zebra fish

Yes

24,216

0

24,216

19.5

No

98,188

1,955

100,143

80.5

Total

122,404

1,955

124,359

100.0

Other fish

Yes

0

0

0

0.0

No

2,556

0

2,556

100.0

Total

2,556

0

2,556

100.0

All Species

Yes

26,090

151

26,241

4.3

No

561,080

29,953

591,033

95.7

Total

587,170

30,104

617,274

100.0



Table 17: Uses of animals for the creation of new genetically altered animal lines in basic research by species and type of research (2015)

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

%

Mammals

Rodents

Mice

59,475

11,835

34,962

17,196

7,257

4,114

29,805

16,561

6,702

13,612

137,627

266

111,133

450,545

76.7

Rats

133

133

700

0

72

0

100

0

43

0

1,702

0

796

3,679

0.6

Guinea-Pigs

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

59

0

0

0

62

0

70

0

0

0

0

0

191

0

Farm animals

Pigs

0

0

4

40

0

0

95

0

0

6

179

0

0

324

0.1

Sheep

0

0

0

0

8

5

0

2

0

0

16

0

0

31

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

4

0

0

0

0

0

4

0

Birds

Domestic fowl

0

0

0

0

0

0

0

60

0

0

117

0

0

177

0

Amphibians

Xenopus

0

541

0

0

0

0

0

0

0

0

6,200

0

518

7,259

1.2

Fish

Zebra fish

3,139

19,911

20,531

0

380

15,988

3,598

2,069

549

2,879

39,075

1,800

12,485

122,404

20.8

Other fish

0

0

26

0

0

248

0

0

1,565

0

701

0

16

2,556

0.4

Totals

Total

62,747

32,479

56,223

17,236

7,717

20,417

33,598

18,766

8,859

16,497

185,617

2,066

124,948

587,170

100

%

10.7

5.5

9.6

2.9

1.3

3.5

5.7

3.2

1.5

2.8

31.6

0.4

21.3

100



Table 18.1: Uses of animals for the creation of new genetically altered animal lines in basic, translational and applied research by species and type of research (Part 1) (2015)

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Mammals

Rodents

Mice

15,348

396

4,887

2,301

263

574

304

836

Rats

44

0

0

264

0

0

44

0

Guinea-Pigs

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

0

0

0

0

0

0

0

Farm animals

Pigs

0

0

0

4

0

0

5

0

Sheep

0

0

0

0

0

0

0

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

Birds

Domestic fowl

0

0

0

0

0

0

0

0

Amphibians

Xenopus

0

0

0

0

0

0

0

0

Fish

Zebra fish

0

1,256

0

0

0

0

0

0

Other fish

0

0

0

0

0

0

0

0

Totals

Total

15,392

1,652

4,887

2,569

263

574

353

836

%

51.5

5.5

16.4

8.6

0.9

1.9

1.2

2.8



Table 18.2: Uses of animals for the creation of new genetically altered animal lines in basic translational and applied research by species and type of research (Part 2) (2015)

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Non-regulatory toxicology and ecotoxicology

Total

%

Mammals

Rodents

Mice

262

377

815

84

577

0

157

57

27,238

90.5

Rats

0

0

0

0

167

111

72

0

702

2.3

Guinea-Pigs

0

0

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

0

0

0

81

0

0

0

81

0.3

Farm animals

Pigs

0

0

17

0

0

0

0

0

26

0.1

Sheep

0

0

0

0

0

0

0

0

0

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

0

0

0

11

91

0

0

0

102

0.3

Amphibians

Xenopus

0

0

0

0

0

0

0

0

0

0

Fish

Zebra fish

0

695

0

4

0

0

0

0

1,955

6.5

Other fish

0

0

0

0

0

0

0

0

0

0

Totals

Total

262

1,072

832

99

916

111

229

57

30,104

100

%

0.9

3.6

2.8

0.3

3

0.4

0.8

0.2

100



Table 19: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, severity and genetic status (2015)

Severity

Genetically altered with a harmful phenotype

Genetically altered without a harmful phenotype

Not genetically altered

Total

%

Mice

Non-recovery

49

700

105

854

0.1

Mild

291,597

430,173

52,600

774,370

85.0

Moderate

45,136

32,800

3,843

81,779

9.0

Severe

29,156

24,346

219

53,721

5.9

Total

365,938

488,019

56,767

910,724

100.0

Rats

Non-recovery

0

104

0

104

1.2

Mild

4,916

2,035

507

7,458

82.8

Moderate

203

253

0

456

5.1

Severe

842

134

9

985

10.9

Total

5,961

2,526

516

9,003

100.0

Dogs

Non-recovery

0

0

0

0

0.0

Mild

0

0

0

0

0.0

Moderate

0

0

0

0

0.0

Severe

7

0

0

7

100.0

Total

7

0

0

7

100.0

Domestic fowl

Non-recovery

0

0

0

0

0.0

Mild

0

231

0

231

71.7

Moderate

58

0

0

58

18.0

Severe

33

0

0

33

10.2

Total

91

231

0

322

100.0

Xenopus

Non-recovery

0

0

0

0

0.0

Mild

0

56

0

56

29.8

Moderate

0

91

0

91

48.4

Severe

0

41

0

41

21.8

Total

0

188

0

188

100.0

Zebra fish

Non-recovery

0

4,679

153

4,832

6.0

Mild

3,065

52,585

4,600

60,250

74.7

Moderate

567

2,426

94

3,087

3.8

Severe

199

11,896

368

12,463

15.5

Total

3,831

71,586

5,215

80,632

100.0

Other fish

Non-recovery

0

0

0

0

0.0

Mild

0

0

0

0

0.0

Moderate

32

278

0

310

100.0

Severe

0

0

0

0

0.0

Total

32

278

0

310

100.0

All Species

Non-recovery

49

5,483

258

5,790

0.6

Mild

299,578

485,080

57,707

842,365

84.1

Moderate

45,996

35,848

3,937

85,781

8.6

Severe

30,237

36,417

596

67,250

6.7

Total

375,860

562,828

62,498

1,001,186

100.0



Table 20: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, reuse and genetic status (2015)

Reuse

Not genetically altered

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

%

Mice

Yes

0

0

0

0

0.0

No

56,767

488,019

365,938

910,724

100.0

Total

56,767

488,019

365,938

910,724

100.0

Rats

Yes

0

0

0

0

0.0

No

516

2,526

5,961

9,003

100.0

Total

516

2,526

5,961

9,003

100.0

Dogs

Yes

0

0

0

0

0.0

No

0

0

7

7

100.0

Total

0

0

7

7

100.0

Domestic fowl

Yes

0

0

0

0

0.0

No

0

231

91

322

100.0

Total

0

231

91

322

100.0

Xenopus

Yes

0

188

0

188

100.0

No

0

0

0

0

0.0

Total

0

188

0

188

100.0

Zebra fish

Yes

1,750

2,217

38

4,005

5.0

No

3,465

69,369

3,793

76,627

95.0

Total

5,215

71,586

3,831

80,632

100.0

Other fish

Yes

0

0

0

0

0.0

No

0

278

32

310

100.0

Total

0

278

32

310

100.0

All Species

Yes

1,750

2,405

38

4,193

0.4

No

60,748

560,423

375,822

996,993

99.6

Total

62,498

562,828

375,860

1,001,186

100.0



EU statistical tables 2016



Part 1: Numbers of animals used for research, testing, routine production and educational purposes in the EU



Table 1: Numbers of animals used for the first time by species (2016)

Number of animals

%

Mammals

Rodents

Mice

5,989,413

61

Rats

1,173,135

11.9

Guinea-Pigs

150,985

1.5

Hamsters (Syrian)

18,614

0.2

Hamsters (Chinese)

519

0

Mongolian gerbil

5,645

0.1

Other rodents

13,712

0.1

Rabbits

Rabbits

350,405

3.6

Carnivores

Cats

1,951

0

Dogs

15,691

0.2

Ferrets

1,530

0

Other carnivores

1,444

0

Farm animals

Horses, donkeys and cross-breeds

3,474

0

Pigs

80,029

0.8

Goats

1,365

0

Sheep

21,240

0.2

Cattle

22,782

0.2

Non-human primates

Prosimians

44

0

Marmoset and tamarins

285

0

Squirrel monkey

8

0

Other species of new world monkeys (Ceboidea)

0

0

Cynomolgus monkey

6,503

0.1

Rhesus monkey

318

0

Vervets (Chlorocebus spp.)

19

0

Baboons

62

0

Other species of old world monkeys (Cercopithecoidea)

0

0

Other mammals

Other mammals

3,637

0

Birds

Domestic fowl

500,920

5.1

Other birds

94,804

1

Reptiles

Reptiles

3,240

0

Amphibians

Rana

4,482

0

Xenopus

18,511

0.2

Other amphibians

19,558

0.2

Fish

Zebra fish

513,011

5.2

Other fish

791,726

8.1

Cephalopods

Cephalopods

8,884

0.1

Totals

Total

9,817,946

100

%

100



Table 2: Place of birth by species (other than non-human primates) (2016)

Animals born in the EU at a registered breeder

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

%

Mammals

Rodents

Mice

5,740,868

191,446

20,197

36,902

5,989,413

61

Rats

1,147,202

17,123

3,641

5,169

1,173,135

12

Guinea-Pigs

149,831

1,076

0

78

150,985

1.5

Hamsters (Syrian)

18,055

77

0

482

18,614

0.2

Hamsters (Chinese)

519

0

0

0

519

0

Mongolian gerbil

5,367

255

6

17

5,645

0.1

Other rodents

1,749

11,733

104

126

13,712

0.1

Rabbits

Rabbits

341,786

6,283

210

2,126

350,405

3.6

Carnivores

Cats

897

694

5

355

1,951

0

Dogs

5,527

5,424

33

4,707

15,691

0.2

Ferrets

1,298

82

6

144

1,530

0

Other carnivores

423

961

23

37

1,444

0

Farm animals

Horses, donkeys and cross-breeds

576

2,894

2

2

3,474

0

Pigs

40,755

39,257

17

0

80,029

0.8

Goats

591

646

128

0

1,365

0

Sheep

8,311

12,872

57

0

21,240

0.2

Cattle

8,541

14,140

101

0

22,782

0.2

Other mammals

Other mammals

623

2,823

187

4

3,637

0

Birds

Domestic fowl

366,599

134,321

0

0

500,920

5.1

Other birds

27,337

60,933

5,168

1,366

94,804

1

Reptiles

Reptiles

1,239

1,650

82

269

3,240

0

Amphibians

Rana

2,466

2,016

0

0

4,482

0

Xenopus

16,096

708

177

1,530

18,511

0.2

Other amphibians

2,478

15,523

1,363

194

19,558

0.2

Fish

Zebra fish

488,212

23,535

0

1,264

513,011

5.2

Other fish

489,106

226,656

50,712

25,252

791,726

8.1

Cephalopods

Cephalopods

8,400

484

0

0

8,884

0.1

Totals

Total

8,874,852

773,612

82,219

80,024

9,810,707

100

%

90.5

7.9

0.8

0.8

100



Table 3: Source of non-human primates by species (2016)

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

%

Non-human primates

New World Monkeys

Prosimians

44

0

0

0

0

0

44

0.6

Marmoset and tamarins

285

0

0

0

0

0

285

3.9

Squirrel monkey

2

0

0

6

0

0

8

0.1

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

Old World Monkeys

Cynomolgus monkey

97

2

2,045

0

4,340

19

6,503

89.8

Rhesus monkey

159

0

143

0

16

0

318

4.4

Vervets (Chlorocebus spp.)

0

0

0

6

13

0

19

0.3

Baboons

57

0

0

0

5

0

62

0.9

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

Totals

Total

644

2

2,188

12

4,374

19

7,239

100

%

8.9

0

30.2

0.2

60.4

0.3

100

Table 4: Generation of non-human primates by species (2016)

F0

F1

F2 or greater

Self-sustaining colony

Total

%

Non-human primates

New World Monkeys

Prosimians

0

0

7

37

44

0.6

Marmoset and tamarins

0

0

19

266

285

3.9

Squirrel monkey

0

6

2

0

8

0.1

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

Old World Monkeys

Cynomolgus monkey

1

1,451

3,210

1,841

6,503

89.8

Rhesus monkey

0

47

144

127

318

4.4

Vervets (Chlorocebus spp.)

0

2

17

0

19

0.3

Baboons

4

22

36

0

62

0.9

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

Totals

Total

5

1,528

3,435

2,271

7,239

100

%

0.1

21.1

47.5

31.4

100



Part 2: Details of all uses of animals for research, testing, routine production and educational purposes in the EU



Table 5: Uses of animals by species, main categories of scientific purposes and severities (2016)

Severity

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Non-recovery

308,547

48,480

3,808

78

591

718

14,214

4

376,440

6.2

Mild

1,571,423

575,186

554,409

1,859

771

13,676

46,507

128

2,763,959

45.7

Moderate

1,160,958

679,490

247,412

22,432

839

0

15,063

0

2,126,194

35.2

Severe

232,177

204,637

312,304

27,703

51

16

466

0

777,354

12.9

Total

3,273,105

1,507,793

1,117,933

52,072

2,252

14,410

76,250

132

6,043,947

100.0

Rats

Non-recovery

64,754

22,406

11,851

71

0

65

24,369

1

123,517

10.4

Mild

96,936

115,346

361,982

1,421

552

159

14,475

30

590,901

49.6

Moderate

135,599

99,351

166,458

167

1,084

0

4,588

23

407,270

34.2

Severe

37,560

14,766

13,402

483

2,895

0

16

0

69,122

5.8

Total

334,849

251,869

553,693

2,142

4,531

224

43,448

54

1,190,810

100.0

Guinea-Pigs

Non-recovery

18,286

1,388

1,704

242

0

0

371

0

21,991

14.5

Mild

3,616

4,381

64,014

440

0

0

1,207

0

73,658

48.6

Moderate

1,568

2,918

32,523

89

0

0

285

0

37,383

24.6

Severe

38

548

18,077

12

0

0

0

0

18,675

12.3

Total

23,508

9,235

116,318

783

0

0

1,863

0

151,707

100.0

Hamsters (Syrian)

Non-recovery

127

10

0

0

0

0

11

0

148

0.8

Mild

431

2,988

6,719

11

0

0

204

0

10,353

55.4

Moderate

1,988

1,095

554

0

0

0

4

0

3,641

19.5

Severe

307

589

3,396

238

0

0

0

0

4,530

24.3

Total

2,853

4,682

10,669

249

0

0

219

0

18,672

100.0

Hamsters (Chinese)

Non-recovery

0

0

0

0

0

0

2

0

2

0.4

Mild

0

287

91

0

0

0

0

0

378

72.8

Moderate

0

0

138

0

0

0

0

0

138

26.6

Severe

0

0

1

0

0

0

0

0

1

0.2

Total

0

287

230

0

0

0

2

0

519

100.0

Mongolian gerbil

Non-recovery

308

6

0

0

0

0

33

0

347

5.7

Mild

467

715

1,952

167

0

0

42

0

3,343

55.1

Moderate

784

1,285

8

31

0

0

10

0

2,118

34.9

Severe

2

261

1

0

0

0

0

0

264

4.3

Total

1,561

2,267

1,961

198

0

0

85

0

6,072

100.0

Other rodents

Non-recovery

489

37

0

0

0

0

2

0

528

3.8

Mild

8,134

383

3,184

0

316

38

17

0

12,072

85.9

Moderate

995

55

50

0

128

0

0

0

1,228

8.7

Severe

35

84

100

0

0

2

0

0

221

1.6

Total

9,653

559

3,334

0

444

40

19

0

14,049

100.0

Rabbits

Non-recovery

2,793

2,917

7,884

0

0

0

848

0

14,442

4.0

Mild

16,076

4,054

53,617

132,741

174

0

1,019

0

207,681

57.0

Moderate

5,550

6,446

27,776

50,850

22

0

230

0

90,874

25.0

Severe

2,539

2,029

1,633

44,934

0

0

0

0

51,135

14.0

Total

26,958

15,446

90,910

228,525

196

0

2,097

0

364,132

100.0

Cats

Non-recovery

27

0

0

0

0

0

0

0

27

0.7

Mild

733

1,116

819

27

0

0

214

0

2,909

78.7

Moderate

45

406

171

0

0

0

0

0

622

16.8

Severe

0

97

40

0

0

0

0

0

137

3.7

Total

805

1,619

1,030

27

0

0

214

0

3,695

100.0

Dogs

Non-recovery

64

138

447

2

0

0

1

0

652

2.8

Mild

1,472

7,764

7,427

141

0

0

372

0

17,176

73.2

Moderate

254

1,272

3,666

29

0

0

30

0

5,251

22.4

Severe

0

80

293

0

0

0

0

0

373

1.6

Total

1,790

9,254

11,833

172

0

0

403

0

23,452

100.0

Ferrets

Non-recovery

96

2

11

0

0

0

8

0

117

7.3

Mild

38

407

410

14

0

0

54

0

923

57.3

Moderate

55

300

40

0

0

0

2

0

397

24.7

Severe

7

166

0

0

0

0

0

0

173

10.7

Total

196

875

461

14

0

0

64

0

1,610

100.0

Other carnivores

Non-recovery

0

0

0

3

0

0

0

0

3

0.2

Mild

282

294

195

0

68

47

0

0

886

48.2

Moderate

500

38

336

0

1

4

0

0

879

47.8

Severe

15

53

0

0

0

1

0

0

69

3.8

Total

797

385

531

3

69

52

0

0

1,837

100.0

Horses, donkeys and cross-breeds

Non-recovery

0

26

0

0

0

0

23

0

49

0.4

Mild

2,278

1,650

218

8,070

2

20

258

0

12,496

95.2

Moderate

127

237

68

110

10

0

20

0

572

4.4

Severe

0

0

0

7

0

0

0

0

7

0.1

Total

2,405

1,913

286

8,187

12

20

301

0

13,124

100.0

Pigs

Non-recovery

4,128

1,826

40

70

0

0

7,491

0

13,555

16.3

Mild

10,209

20,186

10,138

162

447

0

1,505

62

42,709

51.3

Moderate

4,299

13,493

3,477

5

75

0

2,323

0

23,672

28.5

Severe

511

2,470

265

8

0

0

0

0

3,254

3.9

Total

19,147

37,975

13,920

245

522

0

11,319

62

83,190

100.0

Goats

Non-recovery

0

165

0

0

0

0

7

0

172

7.8

Mild

998

96

72

76

30

0

145

0

1,417

63.9

Moderate

239

268

14

0

20

0

64

0

605

27.3

Severe

16

3

4

0

0

0

0

0

23

1.0

Total

1,253

532

90

76

50

0

216

0

2,217

100.0

Sheep

Non-recovery

118

441

53

0

0

0

630

0

1,242

1.8

Mild

6,779

7,096

1,530

44,966

2

0

613

90

61,076

90.0

Moderate

2,164

2,078

240

145

27

0

154

0

4,808

7.1

Severe

192

450

112

0

12

0

0

2

768

1.1

Total

9,253

10,065

1,935

45,111

41

0

1,397

92

67,894

100.0

Cattle

Non-recovery

15

0

0

0

0

0

23

0

38

0.1

Mild

9,118

9,994

2,531

134

1,992

28

3,995

25

27,817

83.5

Moderate

850

1,529

527

15

34

0

2,189

0

5,144

15.4

Severe

57

208

26

0

7

0

6

0

304

0.9

Total

10,040

11,731

3,084

149

2,033

28

6,213

25

33,303

100.0

Prosimians

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

117

0

0

0

0

0

0

0

117

99.2

Moderate

0

1

0

0

0

0

0

0

1

0.8

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

117

1

0

0

0

0

0

0

118

100.0

Marmoset and tamarins

Non-recovery

32

0

0

0

0

0

0

0

32

8.5

Mild

73

48

0

16

0

0

1

0

138

36.7

Moderate

136

41

18

0

0

0

0

0

195

51.9

Severe

2

9

0

0

0

0

0

0

11

2.9

Total

243

98

18

16

0

0

1

0

376

100.0

Squirrel monkey

Non-recovery

7

0

0

0

0

0

0

0

7

87.5

Mild

0

0

0

0

0

0

0

0

0

0.0

Moderate

1

0

0

0

0

0

0

0

1

12.5

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

8

0

0

0

0

0

0

0

8

100.0

Cynomolgus monkey

Non-recovery

26

9

12

4

0

0

17

0

68

0.7

Mild

424

680

3,108

1,018

0

0

19

0

5,249

56.6

Moderate

111

524

3,167

0

0

0

9

0

3,811

41.1

Severe

0

7

146

0

0

0

0

0

153

1.6

Total

561

1,220

6,433

1,022

0

0

45

0

9,281

100.0

Rhesus monkey

Non-recovery

11

0

0

0

0

0

0

0

11

1.9

Mild

104

92

54

3

0

0

5

0

258

45.6

Moderate

138

116

42

0

0

0

0

0

296

52.3

Severe

1

0

0

0

0

0

0

0

1

0.2

Total

254

208

96

3

0

0

5

0

566

100.0

Vervets Chlorocebus spp

Non-recovery

0

0

0

13

0

0

0

0

13

31.7

Mild

6

18

0

0

0

0

0

0

24

58.5

Moderate

0

4

0

0

0

0

0

0

4

9.8

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

6

22

0

13

0

0

0

0

41

100.0

Baboons

Non-recovery

2

0

0

0

0

0

0

0

2

2.0

Mild

46

3

0

0

0

0

0

0

49

49.0

Moderate

15

22

0

0

0

0

0

0

37

37.0

Severe

8

4

0

0

0

0

0

0

12

12.0

Total

71

29

0

0

0

0

0

0

100

100.0

Other species of old world monkeys (Cercopithecoidea)

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

8

18

0

0

0

0

0

0

26

100.0

Moderate

0

0

0

0

0

0

0

0

0

0.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

8

18

0

0

0

0

0

0

26

100.0

Other mammals

Non-recovery

99

10

0

0

0

0

0

0

109

2.8

Mild

2,121

157

0

12

182

259

84

0

2,815

72.1

Moderate

925

28

0

9

0

0

3

0

965

24.7

Severe

1

0

8

8

0

0

0

0

17

0.4

Total

3,146

195

8

29

182

259

87

0

3,906

100.0

Domestic fowl

Non-recovery

5,165

1,024

120

377

0

0

317

0

7,003

1.4

Mild

82,586

77,224

123,546

90,123

3,012

709

2,155

536

379,891

74.9

Moderate

47,122

21,681

21,456

15,158

0

0

838

0

106,255

20.9

Severe

2,298

6,624

4,660

211

269

0

200

0

14,262

2.8

Total

137,171

106,553

149,782

105,869

3,281

709

3,510

536

507,411

100.0

Other birds

Non-recovery

946

50

0

0

0

0

109

0

1,105

1.1

Mild

51,121

14,527

7,251

354

1,527

839

516

14

76,149

78.2

Moderate

8,091

610

514

9,875

20

16

90

0

19,216

19.7

Severe

53

359

527

0

0

0

0

0

939

1.0

Total

60,211

15,546

8,292

10,229

1,547

855

715

14

97,409

100.0

Reptiles

Non-recovery

246

0

0

0

0

0

0

0

246

2.9

Mild

6,017

0

0

300

65

0

27

0

6,409

74.7

Moderate

1,831

16

0

0

0

0

0

0

1,847

21.5

Severe

73

0

0

0

0

0

0

0

73

0.9

Total

8,167

16

0

300

65

0

27

0

8,575

100.0

Rana

Non-recovery

0

0

0

0

850

0

1,056

0

1,906

42.5

Mild

51

0

0

0

0

0

220

0

271

6.0

Moderate

0

0

0

0

600

0

1,000

0

1,600

35.7

Severe

625

0

80

0

0

0

0

0

705

15.7

Total

676

0

80

0

1,450

0

2,276

0

4,482

100.0

Xenopus

Non-recovery

456

0

0

0

0

0

102

0

558

2.0

Mild

23,594

1,296

0

0

8

0

25

0

24,923

89.3

Moderate

955

285

0

0

600

0

4

0

1,844

6.6

Severe

374

0

205

0

0

0

0

0

579

2.1

Total

25,379

1,581

205

0

608

0

131

0

27,904

100.0

Other amphibians

Non-recovery

151

0

0

0

557

0

117

0

825

4.1

Mild

3,076

3,219

72

0

1,733

6,202

164

0

14,466

72.6

Moderate

3,714

0

0

0

0

69

0

0

3,783

19.0

Severe

688

19

0

0

0

146

0

0

853

4.3

Total

7,629

3,238

72

0

2,290

6,417

281

0

19,927

100.0

Zebra fish

Non-recovery

12,794

993

400

0

140

0

328

0

14,655

2.8

Mild

308,999

19,907

15,700

0

566

127

1,067

0

346,366

66.8

Moderate

65,328

61,458

11,207

0

144

0

0

0

138,137

26.6

Severe

4,082

4,373

10,771

0

5

0

0

0

19,231

3.7

Total

391,203

86,731

38,078

0

855

127

1,395

0

518,389

100.0

Other fish

Non-recovery

27,864

5,489

1,505

0

3,027

2,074

1,035

0

40,994

5.1

Mild

389,915

28,218

51,364

0

20,153

43,240

10,686

0

543,576

67.9

Moderate

39,875

41,798

4,719

0

22,303

3,395

176

0

112,266

14.0

Severe

17,504

48,069

25,962

0

12,492

2

0

0

104,029

13.0

Total

475,158

123,574

83,550

0

57,975

48,711

11,897

0

800,865

100.0

Cephalopods

Non-recovery

0

29

0

0

0

0

15

0

44

0.5

Mild

352

8,488

0

0

0

0

0

0

8,840

99.5

Moderate

0

0

0

0

0

0

0

0

0

0.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

352

8,517

0

0

0

0

15

0

8,884

100.0

All Species

Non-recovery

447,551

85,446

27,835

860

5,165

2,857

51,129

5

620,848

6.2

Mild

2,597,600

905,838

1,270,403

282,055

31,600

65,344

85,596

885

5,239,321

52.2

Moderate

1,484,217

936,845

524,581

98,915

25,907

3,484

27,082

23

3,101,054

30.9

Severe

299,165

285,905

392,013

73,604

15,731

167

688

2

1,067,275

10.6

Total

4,828,533

2,214,034

2,214,832

455,434

78,403

71,852

164,495

915

10,028,498

100.0



Table 5.1: Uses of animals in all sub-categories of research and testing by severities (2016)

Non-recovery

Mild [up to and including]

Moderate

Severe

Total

%

Basic research

Oncology

18,053

221,369

276,394

56,301

572,117

5.7

Cardiovascular Blood and Lymphatic System

44,899

157,648

128,554

20,535

351,636

3.5

Nervous System

100,504

422,312

345,194

72,443

940,453

9.4

Respiratory System

5,961

32,168

34,551

2,897

75,577

0.8

Gastrointestinal System including Liver

23,199

69,479

51,109

9,964

153,751

1.5

Musculoskeletal System

2,729

51,884

33,571

5,203

93,387

0.9

Immune System

46,007

410,447

239,413

57,429

753,296

7.5

Urogenital/Reproductive System

14,288

69,827

23,952

4,227

112,294

1.1

Sensory Organs (skin, eyes and ears)

6,715

39,853

23,183

2,809

72,560

0.7

Endocrine System/Metabolism

30,750

172,010

82,806

16,161

301,727

3

Multisystemic

25,389

300,429

86,195

11,214

423,227

4.2

Ethology / Animal Behaviour /Animal Biology

8,762

458,325

87,390

9,565

564,042

5.6

Other basic research

120,295

191,849

71,905

30,417

414,466

4.1

Translational and applied research

Human Cancer

3,991

192,456

304,964

36,850

538,261

5.4

Human Infectious Disorders

6,570

108,222

132,578

35,728

283,098

2.8

Human Cardiovascular Disorders

12,029

21,025

26,146

5,305

64,505

0.6

Human Nervous and Mental Disorders

16,522

150,818

119,040

20,707

307,087

3.1

Human Respiratory Disorders

4,012

30,615

27,559

3,671

65,857

0.7

Human Gastrointestinal Disorders including Liver

3,041

16,688

18,545

5,413

43,687

0.4

Human Musculoskeletal Disorders

444

14,179

18,390

3,129

36,142

0.4

Human Immune Disorders

3,952

25,683

37,496

4,424

71,555

0.7

Human Urogenital/Reproductive Disorders

1,318

5,748

5,382

231

12,679

0.1

Human Sensory Organ Disorders (skin, eyes and ears)

2,185

27,707

22,294

791

52,977

0.5

Human Endocrine/Metabolism Disorders

5,868

58,661

40,233

2,942

107,704

1.1

Other Human Disorders

7,978

8,268

17,307

4,975

38,528

0.4

Animal Diseases and Disorders

7,019

115,958

72,702

64,307

259,986

2.6

Animal Welfare

1,681

57,019

14,321

733

73,754

0.7

Diagnosis of diseases

4,627

22,664

51,776

91,671

170,738

1.7

Plant diseases

0

42

84

0

126

0

Non-regulatory toxicology and ecotoxicology

4,209

50,085

28,028

5,028

87,350

0.9

Regulatory use

Quality control (incl batch safety and potency testing)

Batch safety testing

2

127,240

15,546

9,655

152,443

1.5

Pyrogenicity testing

606

16,985

21,840

3

39,434

0.4

Batch potency testing

9,518

395,222

247,356

292,917

945,013

9.4

Other quality controls

300

63,430

11,096

6,454

81,280

0.8

Toxicity and other safety testing including pharmacology

Acute and sub-acute toxicity testing methods

LD50, LC50

1,885

29,619

9,252

22,396

63,152

0.6

Other lethal methods

0

513

2,595

2,050

5,158

0.1

Non lethal methods

2,508

16,542

10,952

1,404

31,406

0.3

Skin irritation/corrosion

175

2,501

536

10

3,222

0

Skin sensitisation

3,588

43,284

3,782

991

51,645

0.5

Eye irritation/corrosion

131

516

364

64

1,075

0

Repeated dose toxicity

up to 28 days

0

34,908

18,760

1,655

55,323

0.6

29 - 90 days

96

21,041

12,439

982

34,558

0.3

> 90 days

3,187

11,816

6,439

397

21,839

0.2

Carcinogenicity

20

2,506

2,629

173

5,328

0.1

Genotoxicity

156

7,407

1,741

293

9,597

0.1

Reproductive toxicity

342

78,858

17,144

6,471

102,815

1

Developmental toxicity

1,401

82,578

26,871

6,585

117,435

1.2

Neurotoxicity

3

1,799

1,138

126

3,066

0

Kinetics

10

39,085

21,178

644

60,917

0.6

Pharmaco-dynamics (incl safety pharmacology)

1,109

68,601

40,924

3,574

114,208

1.1

Phototoxicity

33

340

94

2

469

0

Ecotoxicity

Acute toxicity

2,305

31,655

2,510

10,111

46,581

0.5

Chronic toxicity

0

13,568

6,472

3,195

23,235

0.2

Reproductive ecotoxicity

0

2,583

1,486

6

4,075

0

Endocrine activity

0

7,597

0

172

7,769

0.1

Bioaccumulation

0

3,111

1,147

0

4,258

0

Other ecotoxicity

0

1,685

341

235

2,261

0

Safety testing in food and feed area

0

25,786

528

13,996

40,310

0.4

Target animal safety

0

11,698

287

37

12,022

0.1

Other toxicity/safety testing

171

5,328

3,520

940

9,959

0.1

Other efficacy and tolerance testing

Other efficacy and tolerance testing

289

122,601

35,614

6,475

164,979

1.6

Routine production

Blood based products

646

160,868

60,197

38,517

260,228

2.6

Monoclonal antibody by mouse ascites method

0

814

20,475

27,645

48,934

0.5

Other product types

214

120,373

18,243

7,442

146,272

1.5

Other

Protection of the natural environment in the interests of the health or welfare of human beings or animals

5,165

31,600

25,907

15,731

78,403

0.8

Preservation of species

2,857

65,344

3,484

167

71,852

0.7

Higher education or training for the acquisition, maintenance or improvement of vocational skills

51,129

85,596

27,082

688

164,495

1.6

Forensic enquiries

5

885

23

2

915

0

Total

620,848

5,239,321

3,101,054

1,067,275

10,028,498

100

%

6.2

52.2

30.9

10.6

100



Table 6: Basic research related uses by species and type of research (2016)

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

%

Mammals

Rodents

Mice

530,789

262,594

630,425

59,649

107,302

75,232

685,471

83,617

57,134

177,404

322,640

25,055

255,793

3,273,105

67.8

Rats

5,544

37,296

163,296

11,429

14,249

5,692

7,346

7,907

6,426

19,442

12,915

17,038

26,269

334,849

6.9

Guinea-Pigs

26

286

364

1,308

213

77

1,971

4

549

487

136

116

17,971

23,508

0.5

Hamsters (Syrian)

230

183

296

0

113

0

107

26

0

45

282

25

1,546

2,853

0.1

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Mongolian gerbil

0

0

536

0

14

17

124

0

541

0

0

0

329

1,561

0

Other rodents

81

0

408

74

27

20

989

74

105

364

374

6,331

806

9,653

0.2

Rabbits

Rabbits

177

1,399

546

1,408

289

801

2,913

505

456

260

553

9,850

7,801

26,958

0.6

Carnivores

Cats

0

24

71

4

156

76

32

14

14

58

230

89

37

805

0

Dogs

0

81

85

2

252

364

157

57

9

15

242

44

482

1,790

0

Ferrets

0

0

145

15

8

0

0

0

6

0

14

8

0

196

0

Other carnivores

0

0

0

0

30

0

323

6

0

0

11

419

8

797

0

Farm animals

Horses, donkeys and cross-breeds

0

81

0

315

30

147

250

486

3

645

0

291

157

2,405

0

Pigs

258

1,708

358

434

5,691

421

1,793

308

77

844

753

5,068

1,434

19,147

0.4

Goats

0

44

9

0

184

0

37

77

0

47

62

749

44

1,253

0

Sheep

20

518

108

149

903

271

291

650

2

262

501

2,156

3,422

9,253

0.2

Cattle

0

202

5

95

500

3

620

307

0

1,868

1,852

3,650

938

10,040

0.2

Non-human primates

Prosimians

0

0

21

0

0

0

0

0

9

0

0

87

0

117

0

Marmoset and tamarins

1

0

71

60

0

0

0

0

0

23

88

0

0

243

0

Squirrel monkey

0

0

8

0

0

0

0

0

0

0

0

0

0

8

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

150

0

0

0

6

0

0

0

28

0

377

561

0

Rhesus monkey

0

54

146

0

0

0

0

0

0

0

32

0

22

254

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

6

6

0

Baboons

0

3

4

0

0

2

26

0

0

0

2

34

0

71

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

8

0

8

0

Other mammals

Other mammals

0

0

155

0

12

0

17

136

35

26

34

2,489

242

3,146

0.1

Birds

Domestic fowl

0

86

4,002

0

16,244

92

6,401

16

479

3,293

4,687

76,657

25,214

137,171

2.8

Other birds

0

459

441

0

160

40

900

55

31

521

54

47,231

10,319

60,211

1.2

Reptiles

Reptiles

0

43

268

0

0

0

73

0

3

0

39

7,331

410

8,167

0.2

Amphibians

Rana

0

0

400

0

0

0

0

0

22

0

0

231

23

676

0

Xenopus

1,456

398

4,532

0

0

254

8

2,492

195

4,051

2,037

3,504

6,452

25,379

0.5

Other amphibians

0

0

0

0

0

470

10

410

22

0

0

3,760

2,957

7,629

0.2

Fish

Zebra fish

31,513

45,789

132,591

419

424

9,015

22,605

14,017

5,946

74,203

24,291

14,640

15,750

391,203

8.1

Other fish

2,022

388

1,012

216

6,950

393

20,826

1,118

496

17,869

51,370

336,841

35,657

475,158

9.8

Cephalopods

Cephalopods

0

0

0

0

0

0

0

12

0

0

0

340

0

352

0

Totals

Total

572,117

351,636

940,453

75,577

153,751

93,387

753,296

112,294

72,560

301,727

423,227

564,042

414,466

4,828,533

100

%

11.8

7.3

19.5

1.6

3.2

1.9

15.6

2.3

1.5

6.2

8.8

11.7

8.6

100

Table 7.1: Translational and applied research related uses by species and type of research (Part 1) (2016)

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Mammals

Rodents

Mice

528,247

214,815

44,272

195,670

40,621

34,274

24,367

65,790

9,270

Rats

6,413

4,236

15,489

101,259

20,944

8,318

8,653

4,763

2,419

Guinea-Pigs

148

1,111

444

430

3,392

42

8

152

106

Hamsters (Syrian)

387

2,325

32

47

0

0

0

0

36

Hamsters (Chinese)

0

287

0

0

0

0

0

0

0

Mongolian gerbil

0

1,406

0

88

0

0

0

0

0

Other rodents

0

312

0

0

71

0

0

0

0

Rabbits

Rabbits

1,985

847

937

100

311

247

1,082

239

31

Carnivores

Cats

0

0

0

0

0

0

0

0

0

Dogs

45

32

87

416

21

45

91

85

4

Ferrets

0

689

0

0

4

98

0

2

0

Other carnivores

0

0

0

0

0

0

0

0

0

Farm animals

Horses, donkeys and cross-breeds

0

8

0

0

0

0

8

6

0

Pigs

175

379

2,594

220

342

416

216

220

507

Goats

6

15

18

4

0

0

43

0

1

Sheep

26

157

520

115

0

7

710

47

238

Cattle

0

75

4

0

40

0

0

0

0

Non-human primates

Prosimians

0

0

0

1

0

0

0

0

0

Marmoset and tamarins

8

0

0

24

0

0

0

16

2

Squirrel monkey

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

14

397

31

106

10

0

21

64

58

Rhesus monkey

0

168

0

11

0

0

0

0

3

Vervets (Chlorocebus spp.)

0

22

0

0

0

0

0

0

0

Baboons

0

22

3

0

0

0

0

0

4

Other species of old world monkeys (Cercopithecoidea)

0

18

0

0

0

0

0

0

0

Other mammals

Other mammals

58

9

10

8

3

0

0

0

0

Birds

Domestic fowl

404

325

0

0

90

240

0

10

0

Other birds

0

6,166

0

0

8

0

0

0

0

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

Xenopus

0

0

0

25

0

0

0

0

0

Other amphibians

0

0

0

0

0

0

0

0

0

Fish

Zebra fish

345

49,277

64

8,544

0

0

943

161

0

Other fish

0

0

0

19

0

0

0

0

0

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

Totals

Total

538,261

283,098

64,505

307,087

65,857

43,687

36,142

71,555

12,679

%

24.3

12.8

2.9

13.9

3

2

1.6

3.2

0.6



Table 7.2: Translational and applied research related uses by species and type of research (Part 2) (2016)

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

%

Mammals

Rodents

Mice

43,784

70,396

24,306

30,301

1,135

157,985

28

22,532

1,507,793

68.1

Rats

6,709

34,075

12,093

1,842

412

3,967

56

20,221

251,869

11.4

Guinea-Pigs

438

0

186

993

0

1,411

0

374

9,235

0.4

Hamsters (Syrian)

0

698

0

1,036

0

9

0

112

4,682

0.2

Hamsters (Chinese)

0

0

0

0

0

0

0

0

287

0

Mongolian gerbil

0

0

0

773

0

0

0

0

2,267

0.1

Other rodents

0

0

0

86

0

0

0

90

559

0

Rabbits

Rabbits

1,436

158

309

6,398

319

632

42

373

15,446

0.7

Carnivores

Cats

0

0

0

1,486

34

96

0

3

1,619

0.1

Dogs

17

154

13

6,216

47

94

0

1,887

9,254

0.4

Ferrets

0

0

0

81

0

1

0

0

875

0

Other carnivores

0

0

0

218

167

0

0

0

385

0

Farm animals

Horses, donkeys and cross-breeds

0

0

0

1,535

227

129

0

0

1,913

0.1

Pigs

476

1,589

245

17,018

12,824

507

0

247

37,975

1.7

Goats

0

0

0

219

169

55

0

2

532

0

Sheep

4

49

55

5,854

1,365

861

0

57

10,065

0.5

Cattle

0

290

0

8,981

2,118

209

0

14

11,731

0.5

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

1

0

Marmoset and tamarins

0

0

24

0

0

0

0

24

98

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

61

17

38

0

0

0

0

403

1,220

0.1

Rhesus monkey

24

2

0

0

0

0

0

0

208

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

22

0

Baboons

0

0

0

0

0

0

0

0

29

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

18

0

Other mammals

Other mammals

0

0

8

82

0

17

0

0

195

0

Birds

Domestic fowl

28

0

0

72,941

30,251

2,149

0

115

106,553

4.8

Other birds

0

0

0

6,671

2,447

86

0

168

15,546

0.7

Reptiles

Reptiles

0

0

0

16

0

0

0

0

16

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

0

Xenopus

0

117

0

19

0

0

0

1,420

1,581

0.1

Other amphibians

0

0

24

79

0

0

0

3,135

3,238

0.1

Fish

Zebra fish

0

120

1,227

648

99

0

0

25,303

86,731

3.9

Other fish

0

39

0

96,464

13,740

2,530

0

10,782

123,574

5.6

Cephalopods

Cephalopods

0

0

0

29

8,400

0

0

88

8,517

0.4

Totals

Total

52,977

107,704

38,528

259,986

73,754

170,738

126

87,350

2,214,034

100

%

2.4

4.9

1.7

11.7

3.3

7.7

0

3.9

100



Table 8: Regulatory uses by species and type of use (2016)

Quality

Toxicity

Other

Quality: Batch safety testing

Quality: Pyrogenicity testing

Quality: Batch potency testing

Quality: Other quality controls

Toxicity and other safety testing including pharmacology

Other efficacy and tolerance testing

Total

%

Mammals

Rodents

Mice

96,993

1,050

633,305

50,300

242,767

93,518

1,117,933

50.5

Rats

11,666

0

151,394

1,603

381,032

7,998

553,693

25

Guinea-Pigs

16,574

0

63,566

2,160

33,808

210

116,318

5.3

Hamsters (Syrian)

14

0

5,889

2,959

1,017

790

10,669

0.5

Hamsters (Chinese)

0

0

0

0

230

0

230

0

Mongolian gerbil

0

0

0

0

1,930

31

1,961

0.1

Other rodents

0

0

0

0

3,304

30

3,334

0.2

Rabbits

Rabbits

2,078

38,384

19,144

3,143

23,831

4,330

90,910

4.1

Carnivores

Cats

65

0

40

98

485

342

1,030

0

Dogs

148

0

87

403

10,071

1,124

11,833

0.5

Ferrets

277

0

127

0

17

40

461

0

Other carnivores

223

0

155

0

33

120

531

0

Farm animals

Horses, donkeys and cross-breeds

10

0

50

0

126

100

286

0

Pigs

1,891

0

2,291

867

4,543

4,328

13,920

0.6

Goats

8

0

48

0

18

16

90

0

Sheep

321

0

723

237

261

393

1,935

0.1

Cattle

193

0

1,120

87

596

1,088

3,084

0.1

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

0

0

18

0

18

0

Squirrel monkey

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

0

0

6,364

69

6,433

0.3

Rhesus monkey

0

0

0

0

90

6

96

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

8

0

8

0

Birds

Domestic fowl

21,675

0

63,791

17,622

12,476

34,218

149,782

6.8

Other birds

229

0

368

885

4,694

2,116

8,292

0.4

Reptiles

Reptiles

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

80

0

80

0

Xenopus

0

0

0

0

205

0

205

0

Other amphibians

0

0

0

0

72

0

72

0

Fish

Zebra fish

0

0

0

188

37,890

0

38,078

1.7

Other fish

78

0

2,915

728

65,717

14,112

83,550

3.8

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

Totals

Total

152,443

39,434

945,013

81,280

831,683

164,979

2,214,832

100

%

6.9

1.8

42.7

3.7

37.6

7.4

100



Table 9.1: Toxicity and other safety testing including pharmacology by species and type of use (Part 1) (2016)

Acute

Repeated Dose

LD50, LC50

Other lethal methods

Non lethal methods

Skin irritation / corrosion

Skin sensitisation

Eye irritation / corrosion

up to 28 days

29 - 90 days

> 90 days

Carcinogenicity

Genotoxicity

Developmental toxicity

Safety testing in food and feed area

Mammals

Rodents

Mice

36,392

1,325

10,112

0

19,931

0

13,164

7,260

2,270

1,793

4,420

164

37,378

Rats

5,384

1,060

16,785

163

0

0

36,800

22,595

15,417

3,535

5,148

101,403

0

Guinea-Pigs

10

0

634

0

31,638

21

4

0

108

0

0

0

0

Hamsters (Syrian)

0

0

472

215

15

0

59

56

80

0

29

0

0

Hamsters (Chinese)

0

0

0

0

0

0

0

230

0

0

0

0

0

Mongolian gerbil

0

0

0

0

0

0

0

0

0

0

0

0

0

Other rodents

70

0

0

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

12

0

701

2,832

54

1,054

730

927

352

0

0

9,678

9

Carnivores

Cats

0

0

0

0

0

0

0

0

12

0

0

0

0

Dogs

0

0

534

0

0

0

2,465

1,371

1,802

0

0

0

0

Ferrets

0

0

0

0

0

0

0

0

0

0

0

0

0

Other carnivores

0

0

0

0

0

0

0

0

0

0

0

0

0

Farm animals

Horses, donkeys and cross-breeds

0

0

0

0

0

0

0

0

0

0

0

0

0

Pigs

0

0

111

12

7

0

681

523

242

0

0

0

148

Goats

0

0

0

0

0

0

0

0

0

0

0

0

0

Sheep

0

0

0

0

0

0

0

0

0

0

0

0

148

Cattle

0

0

0

0

0

0

0

0

0

0

0

0

26

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

0

0

0

0

9

0

0

0

0

0

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

11

0

409

0

0

0

1,399

1,572

1,522

0

0

0

0

Rhesus monkey

0

0

0

0

0

0

12

24

34

0

0

0

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

8

0

0

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

3,960

0

0

0

0

0

0

0

0

0

0

0

1,747

Other birds

272

0

159

0

0

0

0

0

0

0

0

0

854

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

0

0

0

0

Xenopus

0

0

0

0

0

0

0

0

0

0

0

0

0

Other amphibians

0

0

0

0

0

0

0

0

0

0

0

0

0

Fish

Zebra fish

1,502

2,773

624

0

0

0

0

0

0

0

0

6,190

0

Other fish

15,531

0

865

0

0

0

0

0

0

0

0

0

0

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

63,152

5,158

31,406

3,222

51,645

1,075

55,323

34,558

21,839

5,328

9,597

117,435

40,310

%

7.6

0.6

3.8

0.4

6.2

0.1

6.7

4.2

2.6

0.6

1.2

14.2

4.9

Table 9.2: Toxicity and other safety testing including pharmacology by species and type of use (Part 2) (2016)

EcoToxicity

Target animal safety

Neurotoxicity

Kinetics

Pharmaco - dynamics (incl safety pharmacology)

Phototoxicity

Acute toxicity

Chronic toxicity

Reproductive toxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Other toxicity / safety testing

Total

%

Mammals

Rodents

Mice

188

246

29,209

64,776

403

8,236

254

939

0

0

0

4,307

242,767

29.3

Rats

0

396

25,246

42,834

0

1,810

819

97,247

0

0

0

4,390

381,032

46

Guinea-Pigs

0

0

70

1,039

66

186

0

0

0

0

0

32

33,808

4.1

Hamsters (Syrian)

0

0

4

81

0

0

0

0

0

0

0

6

1,017

0.1

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

0

0

0

230

0

Mongolian gerbil

0

0

0

1,930

0

0

0

0

0

0

0

0

1,930

0.2

Other rodents

3,054

0

0

0

0

0

0

0

0

0

180

0

3,304

0.4

Rabbits

Rabbits

76

0

746

1,835

0

9

5

4,598

0

24

0

180

23,822

2.9

Carnivores

Cats

83

0

378

12

0

0

0

0

0

0

0

0

485

0.1

Dogs

158

0

2,274

977

0

0

0

0

0

0

0

490

10,071

1.2

Ferrets

0

0

0

6

0

0

0

0

0

0

0

11

17

0

Other carnivores

33

0

0

0

0

0

0

0

0

0

0

0

33

0

Farm animals

Horses, donkeys and cross-breeds

8

0

90

0

0

0

0

0

0

0

28

0

126

0

Pigs

973

0

1,197

480

0

0

0

0

0

0

48

121

4,543

0.5

Goats

0

0

16

0

0

0

0

0

0

0

0

2

18

0

Sheep

0

0

88

0

0

0

0

0

0

18

0

7

261

0

Cattle

125

0

315

15

0

0

0

0

0

0

0

115

596

0.1

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

9

0

0

0

0

0

0

0

0

0

18

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

18

983

223

0

0

0

31

0

0

0

196

6,364

0.8

Rhesus monkey

0

0

20

0

0

0

0

0

0

0

0

0

90

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

0

0

8

0

Birds

Domestic fowl

6,404

0

263

0

0

0

0

0

0

0

0

102

12,476

1.5

Other birds

274

0

9

0

0

607

158

0

0

0

0

0

2,333

0.3

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

80

0

0

0

0

0

0

80

0

Xenopus

0

0

0

0

0

205

0

0

0

0

0

0

205

0

Other amphibians

0

0

0

0

0

72

0

0

0

0

0

0

72

0

Fish

Zebra fish

0

2,406

0

0

0

6,337

9,414

0

6,080

526

573

0

36,425

4.4

Other fish

646

0

0

0

0

29,039

12,585

0

1,689

3,690

1,432

0

65,477

7.9

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

12,022

3,066

60,917

114,208

469

46,581

23,235

102,815

7,769

4,258

2,261

9,959

827,608

100

%

1.5

0.4

7.4

13.8

0.1

5.6

2.8

12.4

0.9

0.5

0.3

1.2

100


Table 10: Regulatory uses by species and type of legislation (2016)

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Other legislation

Total

%

Mammals

Rodents

Mice

910,195

129,381

15,234

14,994

4,307

1,609

40,150

1,488

575

1,117,933

50.5

Rats

343,737

12,431

2,867

164,098

21,405

3,860

3,250

444

1,601

553,693

25

Guinea-Pigs

70,801

16,028

25,208

3,029

1,085

85

0

0

82

116,318

5.3

Hamsters (Syrian)

905

9,058

706

0

0

0

0

0

0

10,669

0.5

Hamsters (Chinese)

230

0

0

0

0

0

0

0

0

230

0

Mongolian gerbil

0

1,961

0

0

0

0

0

0

0

1,961

0.1

Other rodents

0

0

0

0

3,234

70

0

0

30

3,334

0.2

Rabbits

Rabbits

65,163

14,701

3,073

5,710

954

68

9

0

1,232

90,910

4.1

Carnivores

Cats

50

980

0

0

0

0

0

0

0

1,030

0

Dogs

8,839

2,316

22

106

206

0

0

0

344

11,833

0.5

Ferrets

450

0

0

0

0

0

0

0

11

461

0

Other carnivores

0

518

0

0

0

0

0

0

13

531

0

Farm animals

Horses, donkeys and cross-breeds

49

237

0

0

0

0

0

0

0

286

0

Pigs

3,215

9,233

210

44

0

0

16

1,073

129

13,920

0.6

Goats

50

24

0

0

16

0

0

0

0

90

0

Sheep

42

1,673

90

0

0

0

110

17

3

1,935

0.1

Cattle

0

2,914

0

0

18

0

0

50

102

3,084

0.1

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

18

0

0

0

0

0

0

0

0

18

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

6,433

0

0

0

0

0

0

0

0

6,433

0.3

Rhesus monkey

96

0

0

0

0

0

0

0

0

96

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

8

0

0

0

8

0

Birds

Domestic fowl

1,904

124,752

0

0

230

0

20

20,100

2,776

149,782

6.8

Other birds

0

3,555

0

0

3,623

0

0

1,114

0

8,292

0.4

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

80

0

0

0

0

80

0

Xenopus

0

0

0

0

205

0

0

0

0

205

0

Other amphibians

0

0

0

0

72

0

0

0

0

72

0

Fish

Zebra fish

1,880

872

1,040

12,977

14,474

805

0

0

6,030

38,078

1.7

Other fish

8,399

6,420

494

13,814

11,593

583

0

12,300

29,947

83,550

3.8

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

1,422,456

337,054

48,944

214,772

61,502

7,088

43,555

36,586

42,875

2,214,832

100

%

64.2

15.2

2.2

9.7

2.8

0.3

2

1.7

1.9

100

Table 11: Regulatory uses by species and origin of regulatory requirement (2016)

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

%

Mammals

Rodents

Mice

1,032,534

16,404

68,995

1,117,933

50.5

Rats

546,510

1,111

6,072

553,693

25

Guinea-Pigs

109,983

62

6,273

116,318

5.3

Hamsters (Syrian)

10,663

0

6

10,669

0.5

Hamsters (Chinese)

230

0

0

230

0

Mongolian gerbil

1,961

0

0

1,961

0.1

Other rodents

3,304

30

0

3,334

0.2

Rabbits

Rabbits

68,514

139

22,257

90,910

4.1

Carnivores

Cats

1,024

0

6

1,030

0

Dogs

11,737

19

77

11,833

0.5

Ferrets

461

0

0

461

0

Other carnivores

493

13

25

531

0

Farm animals

Horses, donkeys and cross-breeds

284

0

2

286

0

Pigs

12,315

2

1,603

13,920

0.6

Goats

90

0

0

90

0

Sheep

1,928

3

4

1,935

0.1

Cattle

2,963

91

30

3,084

0.1

Non-human primates

Prosimians

0

0

0

0

0

Marmoset and tamarins

18

0

0

18

0

Squirrel monkey

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

Cynomolgus monkey

6,411

0

22

6,433

0.3

Rhesus monkey

96

0

0

96

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

Baboons

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

Other mammals

Other mammals

8

0

0

8

0

Birds

Domestic fowl

144,335

130

5,317

149,782

6.8

Other birds

8,276

0

16

8,292

0.4

Reptiles

Reptiles

0

0

0

0

0

Amphibians

Rana

80

0

0

80

0

Xenopus

205

0

0

205

0

Other amphibians

72

0

0

72

0

Fish

Zebra fish

36,518

1,560

0

38,078

1.7

Other fish

57,540

25,867

143

83,550

3.8

Cephalopods

Cephalopods

0

0

0

0

0

Totals

Total

2,058,553

45,431

110,848

2,214,832

100

%

92.9

2.1

5

100



Table 12: Routine production uses by species and product type (2016)

Blood based products

Other product types

Monoclonal antibody by mouse ascites method

Total

%

Mammals

Rodents

Mice

1,192

2,591

48,289

52,072

11.4

Rats

1,684

442

16

2,142

0.5

Guinea-Pigs

772

11

0

783

0.2

Hamsters (Syrian)

238

11

0

249

0.1

Hamsters (Chinese)

0

0

0

0

0

Mongolian gerbil

0

198

0

198

0

Other rodents

0

0

0

0

0

Rabbits

Rabbits

191,190

36,706

629

228,525

50.2

Carnivores

Cats

6

21

0

27

0

Dogs

170

2

0

172

0

Ferrets

14

0

0

14

0

Other carnivores

3

0

0

3

0

Farm animals

Horses, donkeys and cross-breeds

8,187

0

0

8,187

1.8

Pigs

20

225

0

245

0.1

Goats

61

15

0

76

0

Sheep

44,014

1,097

0

45,111

9.9

Cattle

123

26

0

149

0

Non-human primates

Prosimians

0

0

0

0

0

Marmoset and tamarins

16

0

0

16

0

Squirrel monkey

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

Cynomolgus monkey

958

64

0

1,022

0.2

Rhesus monkey

0

3

0

3

0

Vervets (Chlorocebus spp.)

0

13

0

13

0

Baboons

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

Other mammals

Other mammals

10

19

0

29

0

Birds

Domestic fowl

1,655

104,214

0

105,869

23.2

Other birds

9,915

314

0

10,229

2.2

Reptiles

Reptiles

0

300

0

300

0.1

Amphibians

Rana

0

0

0

0

0

Xenopus

0

0

0

0

0

Other amphibians

0

0

0

0

0

Fish

Zebra fish

0

0

0

0

0

Other fish

0

0

0

0

0

Cephalopods

Cephalopods

0

0

0

0

0

Totals

Total

260,228

146,272

48,934

455,434

100

%

57.1

32.1

10.7

100



Table 13: Reuses of animals by species and main categories of scientific purposes in research, testing routine production and education (2016)

Reuse

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Yes

14,006

8,806

26,148

180

0

0

5,394

0

54,534

0.9

No

3,259,099

1,498,987

1,091,785

51,892

2,252

14,410

70,856

132

5,989,413

99.1

Total

3,273,105

1,507,793

1,117,933

52,072

2,252

14,410

76,250

132

6,043,947

100.0

Rats

Yes

6,462

4,959

3,250

138

0

0

2,826

40

17,675

1.5

No

328,387

246,910

550,443

2,004

4,531

224

40,622

14

1,173,135

98.5

Total

334,849

251,869

553,693

2,142

4,531

224

43,448

54

1,190,810

100.0

Guinea-Pigs

Yes

31

50

518

5

0

0

118

0

722

0.5

No

23,477

9,185

115,800

778

0

0

1,745

0

150,985

99.5

Total

23,508

9,235

116,318

783

0

0

1,863

0

151,707

100.0

Hamsters (Syrian)

Yes

25

4

6

11

0

0

12

0

58

0.3

No

2,828

4,678

10,663

238

0

0

207

0

18,614

99.7

Total

2,853

4,682

10,669

249

0

0

219

0

18,672

100.0

Hamsters (Chinese)

Yes

0

0

0

0

0

0

0

0

0

0.0

No

0

287

230

0

0

0

2

0

519

100.0

Total

0

287

230

0

0

0

2

0

519

100.0

Mongolian gerbil

Yes

30

397

0

0

0

0

0

0

427

7.0

No

1,531

1,870

1,961

198

0

0

85

0

5,645

93.0

Total

1,561

2,267

1,961

198

0

0

85

0

6,072

100.0

Other rodents

Yes

337

0

0

0

0

0

0

0

337

2.4

No

9,316

559

3,334

0

444

40

19

0

13,712

97.6

Total

9,653

559

3,334

0

444

40

19

0

14,049

100.0

Rabbits

Yes

133

278

12,022

932

5

0

357

0

13,727

3.8

No

26,825

15,168

78,888

227,593

191

0

1,740

0

350,405

96.2

Total

26,958

15,446

90,910

228,525

196

0

2,097

0

364,132

100.0

Cats

Yes

426

703

403

6

0

0

206

0

1,744

47.2

No

379

916

627

21

0

0

8

0

1,951

52.8

Total

805

1,619

1,030

27

0

0

214

0

3,695

100.0

Dogs

Yes

881

2,985

3,436

143

0

0

316

0

7,761

33.1

No

909

6,269

8,397

29

0

0

87

0

15,691

66.9

Total

1,790

9,254

11,833

172

0

0

403

0

23,452

100.0

Ferrets

Yes

2

24

0

0

0

0

54

0

80

5.0

No

194

851

461

14

0

0

10

0

1,530

95.0

Total

196

875

461

14

0

0

64

0

1,610

100.0

Other carnivores

Yes

346

4

40

3

0

0

0

0

393

21.4

No

451

381

491

0

69

52

0

0

1,444

78.6

Total

797

385

531

3

69

52

0

0

1,837

100.0

Horses, donkeys and cross-breeds

Yes

1,131

247

26

8,077

2

0

167

0

9,650

73.5

No

1,274

1,666

260

110

10

20

134

0

3,474

26.5

Total

2,405

1,913

286

8,187

12

20

301

0

13,124

100.0

Pigs

Yes

347

1,168

606

0

75

0

965

0

3,161

3.8

No

18,800

36,807

13,314

245

447

0

10,354

62

80,029

96.2

Total

19,147

37,975

13,920

245

522

0

11,319

62

83,190

100.0

Goats

Yes

766

5

0

6

30

0

45

0

852

38.4

No

487

527

90

70

20

0

171

0

1,365

61.6

Total

1,253

532

90

76

50

0

216

0

2,217

100.0

Sheep

Yes

3,576

316

246

42,277

0

0

239

0

46,654

68.7

No

5,677

9,749

1,689

2,834

41

0

1,158

92

21,240

31.3

Total

9,253

10,065

1,935

45,111

41

0

1,397

92

67,894

100.0

Cattle

Yes

2,600

2,645

336

19

1,653

0

3,268

0

10,521

31.6

No

7,440

9,086

2,748

130

380

28

2,945

25

22,782

68.4

Total

10,040

11,731

3,084

149

2,033

28

6,213

25

33,303

100.0

Prosimians

Yes

74

0

0

0

0

0

0

0

74

62.7

No

43

1

0

0

0

0

0

0

44

37.3

Total

117

1

0

0

0

0

0

0

118

100.0

Marmoset and tamarins

Yes

40

26

9

16

0

0

0

0

91

24.2

No

203

72

9

0

0

0

1

0

285

75.8

Total

243

98

18

16

0

0

1

0

376

100.0

Squirrel monkey

Yes

0

0

0

0

0

0

0

0

0

0.0

No

8

0

0

0

0

0

0

0

8

100.0

Total

8

0

0

0

0

0

0

0

8

100.0

Cynomolgus monkey

Yes

42

671

1,054

968

0

0

43

0

2,778

29.9

No

519

549

5,379

54

0

0

2

0

6,503

70.1

Total

561

1,220

6,433

1,022

0

0

45

0

9,281

100.0

Rhesus monkey

Yes

128

87

26

3

0

0

4

0

248

43.8

No

126

121

70

0

0

0

1

0

318

56.2

Total

254

208

96

3

0

0

5

0

566

100.0

Vervets Chlorocebus spp

Yes

0

22

0

0

0

0

0

0

22

53.7

No

6

0

0

13

0

0

0

0

19

46.3

Total

6

22

0

13

0

0

0

0

41

100.0

Baboons

Yes

20

18

0

0

0

0

0

0

38

38.0

No

51

11

0

0

0

0

0

0

62

62.0

Total

71

29

0

0

0

0

0

0

100

100.0

Other species of old world monkeys (Cercopithecoidea)

Yes

8

18

0

0

0

0

0

0

26

100.0

No

0

0

0

0

0

0

0

0

0

0.0

Total

8

18

0

0

0

0

0

0

26

100.0

Other mammals

Yes

211

50

0

0

5

0

3

0

269

6.9

No

2,935

145

8

29

177

259

84

0

3,637

93.1

Total

3,146

195

8

29

182

259

87

0

3,906

100.0

Domestic fowl

Yes

2,670

494

2,284

63

0

0

980

0

6,491

1.3

No

134,501

106,059

147,498

105,806

3,281

709

2,530

536

500,920

98.7

Total

137,171

106,553

149,782

105,869

3,281

709

3,510

536

507,411

100.0

Other birds

Yes

1,763

185

140

0

108

0

409

0

2,605

2.7

No

58,448

15,361

8,152

10,229

1,439

855

306

14

94,804

97.3

Total

60,211

15,546

8,292

10,229

1,547

855

715

14

97,409

100.0

Reptiles

Yes

5,026

0

0

300

0

0

9

0

5,335

62.2

No

3,141

16

0

0

65

0

18

0

3,240

37.8

Total

8,167

16

0

300

65

0

27

0

8,575

100.0

Rana

Yes

0

0

0

0

0

0

0

0

0

0.0

No

676

0

80

0

1,450

0

2,276

0

4,482

100.0

Total

676

0

80

0

1,450

0

2,276

0

4,482

100.0

Xenopus

Yes

8,786

585

0

0

0

0

22

0

9,393

33.7

No

16,593

996

205

0

608

0

109

0

18,511

66.3

Total

25,379

1,581

205

0

608

0

131

0

27,904

100.0

Other amphibians

Yes

106

24

0

0

239

0

0

0

369

1.9

No

7,523

3,214

72

0

2,051

6,417

281

0

19,558

98.1

Total

7,629

3,238

72

0

2,290

6,417

281

0

19,927

100.0

Zebra fish

Yes

5,244

0

134

0

0

0

0

0

5,378

1.0

No

385,959

86,731

37,944

0

855

127

1,395

0

513,011

99.0

Total

391,203

86,731

38,078

0

855

127

1,395

0

518,389

100.0

Other fish

Yes

8,948

50

92

0

0

0

49

0

9,139

1.1

No

466,210

123,524

83,458

0

57,975

48,711

11,848

0

791,726

98.9

Total

475,158

123,574

83,550

0

57,975

48,711

11,897

0

800,865

100.0

Cephalopods

Yes

0

0

0

0

0

0

0

0

0

0.0

No

352

8,517

0

0

0

0

15

0

8,884

100.0

Total

352

8,517

0

0

0

0

15

0

8,884

100.0

All Species

Yes

64,165

24,821

50,776

53,147

2,117

0

15,486

40

210,552

2.1

No

4,764,368

2,189,213

2,164,056

402,287

76,286

71,852

149,009

875

9,817,946

97.9

Total

4,828,533

2,214,034

2,214,832

455,434

78,403

71,852

164,495

915

10,028,498

100.0

Table 14: Genetic status of animals used by species and main categories of scientific purposes (2016)

Genetic status

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Not altered

1,448,135

1,026,697

1,067,308

51,402

2,203

333

67,499

64

3,663,641

60.6

Non harmful

1,546,445

356,991

49,339

670

49

13,876

8,224

40

1,975,634

32.7

Harmful

278,525

124,105

1,286

0

0

201

527

28

404,672

6.7

Total

3,273,105

1,507,793

1,117,933

52,072

2,252

14,410

76,250

132

6,043,947

100.0

Rats

Not altered

317,730

243,625

551,023

1,840

4,517

82

43,185

54

1,162,056

97.6

Non harmful

13,013

3,988

2,620

302

14

142

251

0

20,330

1.7

Harmful

4,106

4,256

50

0

0

0

12

0

8,424

0.7

Total

334,849

251,869

553,693

2,142

4,531

224

43,448

54

1,190,810

100.0

Guinea-Pigs

Not altered

23,508

9,235

116,318

783

0

0

1,863

0

151,707

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

23,508

9,235

116,318

783

0

0

1,863

0

151,707

100.0

Hamsters (Syrian)

Not altered

2,853

4,682

10,669

249

0

0

219

0

18,672

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

2,853

4,682

10,669

249

0

0

219

0

18,672

100.0

Hamsters (Chinese)

Not altered

0

287

230

0

0

0

2

0

519

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

0

287

230

0

0

0

2

0

519

100.0

Mongolian gerbil

Not altered

1,561

2,267

1,961

198

0

0

85

0

6,072

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,561

2,267

1,961

198

0

0

85

0

6,072

100.0

Other rodents

Not altered

9,653

559

3,334

0

444

40

19

0

14,049

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

9,653

559

3,334

0

444

40

19

0

14,049

100.0

Rabbits

Not altered

26,899

15,446

90,910

200,806

196

0

2,097

0

336,354

92.4

Non harmful

29

0

0

27,719

0

0

0

0

27,748

7.6

Harmful

30

0

0

0

0

0

0

0

30

0.0

Total

26,958

15,446

90,910

228,525

196

0

2,097

0

364,132

100.0

Cats

Not altered

805

1,619

1,030

27

0

0

214

0

3,695

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

805

1,619

1,030

27

0

0

214

0

3,695

100.0

Dogs

Not altered

1,777

9,223

11,833

172

0

0

403

0

23,408

99.8

Non harmful

0

14

0

0

0

0

0

0

14

0.1

Harmful

13

17

0

0

0

0

0

0

30

0.1

Total

1,790

9,254

11,833

172

0

0

403

0

23,452

100.0

Ferrets

Not altered

196

875

461

14

0

0

64

0

1,610

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

196

875

461

14

0

0

64

0

1,610

100.0

Other carnivores

Not altered

797

385

531

3

69

52

0

0

1,837

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

797

385

531

3

69

52

0

0

1,837

100.0

Horses, donkeys and cross-breeds

Not altered

2,405

1,913

286

8,187

12

20

301

0

13,124

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

2,405

1,913

286

8,187

12

20

301

0

13,124

100.0

Pigs

Not altered

19,069

37,704

13,920

245

522

0

11,319

62

82,841

99.6

Non harmful

54

124

0

0

0

0

0

0

178

0.2

Harmful

24

147

0

0

0

0

0

0

171

0.2

Total

19,147

37,975

13,920

245

522

0

11,319

62

83,190

100.0

Goats

Not altered

1,253

532

90

76

50

0

216

0

2,217

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,253

532

90

76

50

0

216

0

2,217

100.0

Sheep

Not altered

9,233

10,065

1,935

45,111

41

0

1,397

92

67,874

100.0

Non harmful

20

0

0

0

0

0

0

0

20

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

9,253

10,065

1,935

45,111

41

0

1,397

92

67,894

100.0

Cattle

Not altered

10,040

11,731

3,084

149

2,033

28

6,213

25

33,303

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

10,040

11,731

3,084

149

2,033

28

6,213

25

33,303

100.0

Prosimians

Not altered

117

1

0

0

0

0

0

0

118

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

117

1

0

0

0

0

0

0

118

100.0

Marmoset and tamarins

Not altered

243

98

18

16

0

0

1

0

376

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

243

98

18

16

0

0

1

0

376

100.0

Squirrel monkey

Not altered

8

0

0

0

0

0

0

0

8

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

8

0

0

0

0

0

0

0

8

100.0

Cynomolgus monkey

Not altered

561

1,220

6,433

1,022

0

0

45

0

9,281

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

561

1,220

6,433

1,022

0

0

45

0

9,281

100.0

Rhesus monkey

Not altered

254

208

96

3

0

0

5

0

566

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

254

208

96

3

0

0

5

0

566

100.0

Vervets Chlorocebus spp

Not altered

6

22

0

13

0

0

0

0

41

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

6

22

0

13

0

0

0

0

41

100.0

Baboons

Not altered

71

29

0

0

0

0

0

0

100

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

71

29

0

0

0

0

0

0

100

100.0

Other species of old world monkeys (Cercopithecoidea)

Not altered

8

18

0

0

0

0

0

0

26

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

8

18

0

0

0

0

0

0

26

100.0

Other mammals

Not altered

3,146

195

8

29

182

259

87

0

3,906

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

3,146

195

8

29

182

259

87

0

3,906

100.0

Domestic fowl

Not altered

136,789

106,214

149,782

105,869

3,281

709

3,510

536

506,690

99.9

Non harmful

354

339

0

0

0

0

0

0

693

0.1

Harmful

28

0

0

0

0

0

0

0

28

0.0

Total

137,171

106,553

149,782

105,869

3,281

709

3,510

536

507,411

100.0

Other birds

Not altered

60,211

15,546

8,292

10,229

1,547

855

715

14

97,409

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

60,211

15,546

8,292

10,229

1,547

855

715

14

97,409

100.0

Reptiles

Not altered

8,167

16

0

300

65

0

27

0

8,575

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

8,167

16

0

300

65

0

27

0

8,575

100.0

Rana

Not altered

676

0

80

0

1,450

0

2,276

0

4,482

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

676

0

80

0

1,450

0

2,276

0

4,482

100.0

Xenopus

Not altered

20,363

1,508

205

0

608

0

131

0

22,815

81.8

Non harmful

4,452

73

0

0

0

0

0

0

4,525

16.2

Harmful

564

0

0

0

0

0

0

0

564

2.0

Total

25,379

1,581

205

0

608

0

131

0

27,904

100.0

Other amphibians

Not altered

7,194

3,238

72

0

2,290

6,417

281

0

19,492

97.8

Non harmful

435

0

0

0

0

0

0

0

435

2.2

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

7,629

3,238

72

0

2,290

6,417

281

0

19,927

100.0

Zebra fish

Not altered

115,779

33,684

38,078

0

855

68

1,056

0

189,520

36.6

Non harmful

259,374

48,473

0

0

0

59

339

0

308,245

59.5

Harmful

16,050

4,574

0

0

0

0

0

0

20,624

4.0

Total

391,203

86,731

38,078

0

855

127

1,395

0

518,389

100.0

Other fish

Not altered

471,548

119,675

83,395

0

57,975

48,711

11,897

0

793,201

99.0

Non harmful

3,078

3,899

155

0

0

0

0

0

7,132

0.9

Harmful

532

0

0

0

0

0

0

0

532

0.1

Total

475,158

123,574

83,550

0

57,975

48,711

11,897

0

800,865

100.0

Cephalopods

Not altered

352

8,517

0

0

0

0

15

0

8,884

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

352

8,517

0

0

0

0

15

0

8,884

100.0

All Species

Harmful

299,872

133,099

1,336

0

0

201

539

28

435,075

4.3

Non harmful

1,827,254

413,901

52,114

28,691

63

14,077

8,814

40

2,344,954

23.4

Not altered

2,701,407

1,667,034

2,161,382

426,743

78,340

57,574

155,142

847

7,248,469

72.3

Total

4,828,533

2,214,034

2,214,832

455,434

78,403

71,852

164,495

915

10,028,498

100.0



Part 3: Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU



Table 15: Use of animals for the creation of new genetically altered animal lines by research type species and severity (2016)

Severity

Basic research

Translational and applied research

Total

%

Mice

Non-recovery

11,199

1,429

12,628

3.5

Mild

253,536

16,280

269,816

75.0

Moderate

56,436

12,345

68,781

19.1

Severe

7,988

681

8,669

2.4

Total

329,159

30,735

359,894

100.0

Rats

Non-recovery

519

12

531

8.8

Mild

2,990

416

3,406

56.4

Moderate

1,670

53

1,723

28.5

Severe

347

32

379

6.3

Total

5,526

513

6,039

100.0

Guinea-Pigs

Non-recovery

47

0

47

100.0

Mild

0

0

0

0.0

Moderate

0

0

0

0.0

Severe

0

0

0

0.0

Total

47

0

47

100.0

Other rodents

Non-recovery

6

0

6

100.0

Mild

0

0

0

0.0

Moderate

0

0

0

0.0

Severe

0

0

0

0.0

Total

6

0

6

100.0

Rabbits

Non-recovery

223

371

594

61.4

Mild

0

0

0

0.0

Moderate

17

356

373

38.6

Severe

0

0

0

0.0

Total

240

727

967

100.0

Pigs

Non-recovery

0

0

0

0.0

Mild

184

12

196

69.0

Moderate

61

0

61

21.5

Severe

27

0

27

9.5

Total

272

12

284

100.0

Sheep

Non-recovery

0

0

0

0.0

Mild

24

0

24

12.6

Moderate

167

0

167

87.4

Severe

0

0

0

0.0

Total

191

0

191

100.0

Domestic fowl

Non-recovery

0

0

0

0.0

Mild

401

114

515

100.0

Moderate

0

0

0

0.0

Severe

0

0

0

0.0

Total

401

114

515

100.0

Xenopus

Non-recovery

0

0

0

0.0

Mild

965

85

1,050

95.5

Moderate

50

0

50

4.5

Severe

0

0

0

0.0

Total

1,015

85

1,100

100.0

Zebra fish

Non-recovery

1,643

0

1,643

1.3

Mild

107,496

1,779

109,275

89.5

Moderate

8,868

0

8,868

7.3

Severe

2,033

263

2,296

1.9

Total

120,040

2,042

122,082

100.0

Other fish

Non-recovery

558

0

558

5.2

Mild

10,040

0

10,040

93.5

Moderate

139

0

139

1.3

Severe

0

0

0

0.0

Total

10,737

0

10,737

100.0

All Species

Non-recovery

14,195

1,812

16,007

3.2

Mild

375,636

18,686

394,322

78.6

Moderate

67,408

12,754

80,162

16.0

Severe

10,395

976

11,371

2.3

Total

467,634

34,228

501,862

100.0



Table 16: Use of animals for the creation of new genetically altered animal lines by research type species and severity (2016)

Reuse

Basic research

Translational and applied research

Total

%

Mice

Yes

2,396

21

2,417

0.7

No

326,763

30,714

357,477

99.3

Total

329,159

30,735

359,894

100.0

Rats

Yes

0

0

0

0.0

No

5,526

513

6,039

100.0

Total

5,526

513

6,039

100.0

Guinea-Pigs

Yes

0

0

0

0.0

No

47

0

47

100.0

Total

47

0

47

100.0

Other rodents

Yes

0

0

0

0.0

No

6

0

6

100.0

Total

6

0

6

100.0

Rabbits

Yes

0

0

0

0.0

No

240

727

967

100.0

Total

240

727

967

100.0

Pigs

Yes

0

0

0

0.0

No

272

12

284

100.0

Total

272

12

284

100.0

Sheep

Yes

0

0

0

0.0

No

191

0

191

100.0

Total

191

0

191

100.0

Domestic fowl

Yes

0

0

0

0.0

No

401

114

515

100.0

Total

401

114

515

100.0

Xenopus

Yes

0

0

0

0.0

No

1,015

85

1,100

100.0

Total

1,015

85

1,100

100.0

Zebra fish

Yes

6,289

0

6,289

5.2

No

113,751

2,042

115,793

94.8

Total

120,040

2,042

122,082

100.0

Other fish

Yes

0

0

0

0.0

No

10,737

0

10,737

100.0

Total

10,737

0

10,737

100.0

All Species

Yes

8,685

21

8,706

1.7

No

458,949

34,207

493,156

98.3

Total

467,634

34,228

501,862

100.0



Table 17: Uses of animals for the creation of new genetically altered animal lines in basic research by species and type of research (2016)

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

%

Mammals

Rodents

Mice

60,864

13,916

52,874

213

6,317

5,259

35,124

12,918

8,165

13,900

87,472

207

31,930

329,159

70.4

Rats

0

1,272

1,697

0

1

0

283

34

0

0

1,336

0

903

5,526

1.2

Guinea-Pigs

0

0

0

0

0

0

0

47

0

0

0

0

0

47

0

Other rodents

0

0

0

0

0

0

0

0

0

0

0

6

0

6

0

Rabbits

Rabbits

0

76

0

0

0

116

0

24

0

0

0

0

24

240

0.1

Farm animals

Pigs

0

3

27

0

0

0

135

0

0

13

94

0

0

272

0.1

Sheep

0

0

2

22

0

0

0

0

0

0

167

0

0

191

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

0

0

0

0

0

0

98

54

0

0

249

0

0

401

0.1

Amphibians

Xenopus

0

201

176

0

0

0

0

0

300

198

0

0

140

1,015

0.2

Fish

Zebra fish

2,879

24,519

23,840

0

540

2,245

9,585

5,934

11,439

2,164

25,629

2,300

8,966

120,040

25.7

Other fish

126

6

558

0

0

0

0

1,573

7,601

0

860

0

13

10,737

2.3

Totals

Total

63,869

39,993

79,174

235

6,858

7,620

45,225

20,584

27,505

16,275

115,807

2,513

41,976

467,634

100

%

13.7

8.6

16.9

0.1

1.5

1.6

9.7

4.4

5.9

3.5

24.8

0.5

9

100



Table 18.1: Uses of animals for the creation of new genetically altered animal lines in basic, translational and applied research by species and type of research (Part 1) (2016)

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Mammals

Rodents

Mice

14,063

386

2,391

2,950

407

1,117

481

745

Rats

99

0

0

0

0

0

88

0

Guinea-Pigs

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

0

0

0

0

0

0

0

Farm animals

Pigs

0

0

0

0

0

0

0

0

Sheep

0

0

0

0

0

0

0

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

Birds

Domestic fowl

0

0

0

0

0

0

0

0

Amphibians

Xenopus

0

0

0

0

0

0

0

0

Fish

Zebra fish

0

461

100

0

0

0

396

0

Other fish

0

0

0

0

0

0

0

0

Totals

Total

14,162

847

2,491

2,950

407

1,117

965

745

%

41.7

2.5

7.3

8.7

1.2

3.3

2.8

2.2



Table 18.2: Uses of animals for the creation of new genetically altered animal lines in basic translational and applied research by species and type of research (Part 2) (2016)

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Non-regulatory toxicology and ecotoxicology

Total

%

Mammals

Rodents

Mice

481

487

5,682

1,107

197

0

239

2

30,735

89.8

Rats

0

234

0

0

0

92

0

0

513

1.5

Guinea-Pigs

0

0

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

0

565

0

162

0

0

0

727

2.1

Farm animals

Pigs

0

0

0

0

12

0

0

0

12

0

Sheep

0

0

0

0

0

0

0

0

0

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

0

0

0

20

94

0

0

0

114

0.3

Amphibians

Xenopus

0

85

0

0

0

0

0

0

85

0.2

Fish

Zebra fish

0

1,073

0

12

0

0

0

0

2,042

6

Other fish

0

0

0

0

0

0

0

0

0

0

Totals

Total

481

1,879

6,247

1,139

465

92

239

2

34,228

100

%

1.4

5.5

18.3

3.3

1.4

0.3

0.7

0

100



Table 19: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, severity and genetic status (2016)

Severity

Genetically altered with a harmful phenotype

Genetically altered without a harmful phenotype

Not genetically altered

Total

%

Mice

Non-recovery

244

425

47

716

0.1

Mild

133,810

372,090

32,786

538,686

86.3

Moderate

22,041

15,269

8,357

45,667

7.3

Severe

29,336

9,515

68

38,919

6.2

Total

185,431

397,299

41,258

623,988

100.0

Rats

Non-recovery

0

0

0

0

0.0

Mild

3,887

3,101

258

7,246

78.0

Moderate

436

56

1,059

1,551

16.7

Severe

428

47

22

497

5.3

Total

4,751

3,204

1,339

9,294

100.0

Dogs

Non-recovery

0

0

0

0

0.0

Mild

0

0

0

0

0.0

Moderate

0

0

0

0

0.0

Severe

17

0

0

17

100.0

Total

17

0

0

17

100.0

Other mammals

Non-recovery

0

0

0

0

0.0

Mild

0

0

4

4

100.0

Moderate

0

0

0

0

0.0

Severe

0

0

0

0

0.0

Total

0

0

4

4

100.0

Domestic fowl

Non-recovery

0

0

0

0

0.0

Mild

0

345

32

377

64.8

Moderate

135

0

0

135

23.2

Severe

70

0

0

70

12.0

Total

205

345

32

582

100.0

Xenopus

Non-recovery

0

0

0

0

0.0

Mild

0

141

79

220

84.9

Moderate

0

14

0

14

5.4

Severe

0

25

0

25

9.7

Total

0

180

79

259

100.0

Zebra fish

Non-recovery

0

286

29

315

0.5

Mild

3,018

55,371

4,217

62,606

93.7

Moderate

480

2,694

187

3,361

5.0

Severe

3

503

6

512

0.8

Total

3,501

58,854

4,439

66,794

100.0

Other fish

Non-recovery

0

0

0

0

0.0

Mild

1

0

0

1

0.2

Moderate

0

570

0

570

99.8

Severe

0

0

0

0

0.0

Total

1

570

0

571

100.0

All Species

Non-recovery

244

711

76

1,031

0.1

Mild

140,716

431,048

37,376

609,140

86.8

Moderate

23,092

18,603

9,603

51,298

7.3

Severe

29,854

10,090

96

40,040

5.7

Total

193,906

460,452

47,151

701,509

100.0



Table 20: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, reuse and genetic status (2016)

Reuse

Not genetically altered

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

%

Mice

Yes

0

191

0

191

0.0

No

41,258

397,108

185,431

623,797

100.0

Total

41,258

397,299

185,431

623,988

100.0

Rats

Yes

0

0

0

0

0.0

No

1,339

3,204

4,751

9,294

100.0

Total

1,339

3,204

4,751

9,294

100.0

Dogs

Yes

0

0

0

0

0.0

No

0

0

17

17

100.0

Total

0

0

17

17

100.0

Other mammals

Yes

0

0

0

0

0.0

No

4

0

0

4

100.0

Total

4

0

0

4

100.0

Domestic fowl

Yes

0

0

0

0

0.0

No

32

345

205

582

100.0

Total

32

345

205

582

100.0

Xenopus

Yes

69

41

0

110

42.5

No

10

139

0

149

57.5

Total

79

180

0

259

100.0

Zebra fish

Yes

303

369

0

672

1.0

No

4,136

58,485

3,501

66,122

99.0

Total

4,439

58,854

3,501

66,794

100.0

Other fish

Yes

0

0

0

0

0.0

No

0

570

1

571

100.0

Total

0

570

1

571

100.0

All Species

Yes

372

601

0

973

0.1

No

46,779

459,851

193,906

700,536

99.9

Total

47,151

460,452

193,906

701,509

100.0



EU statistical tables 2017



Part 1: Numbers of animals used for research, testing, routine production and educational purposes in the EU



Table 1: Numbers of animals used for the first time by species (2017)

Number of animals

%

Mammals

Rodents

Mice

5,707,471

60.8

Rats

1,146,299

12.2

Guinea-Pigs

144,824

1.5

Hamsters (Syrian)

12,700

0.1

Hamsters (Chinese)

187

0

Mongolian gerbil

5,239

0.1

Other rodents

25,172

0.3

Rabbits

Rabbits

351,961

3.7

Carnivores

Cats

1,879

0

Dogs

13,688

0.1

Ferrets

2,016

0

Other carnivores

2,386

0

Farm animals

Horses, donkeys and cross-breeds

2,414

0

Pigs

71,522

0.8

Goats

1,563

0

Sheep

18,812

0.2

Cattle

30,643

0.3

Non-human primates

Prosimians

98

0

Marmoset and tamarins

465

0

Squirrel monkey

8

0

Other species of new world monkeys (Ceboidea)

3

0

Cynomolgus monkey

7,227

0.1

Rhesus monkey

353

0

Vervets (Chlorocebus spp.)

33

0

Baboons

25

0

Other species of old world monkeys (Cercopithecoidea)

23

0

Other mammals

Other mammals

26,335

0.3

Birds

Domestic fowl

464,553

4.9

Other birds

99,410

1.1

Reptiles

Reptiles

2,937

0

Amphibians

Rana

3,485

0

Xenopus

13,539

0.1

Other amphibians

10,683

0.1

Fish

Zebra fish

499,763

5.3

Other fish

719,932

7.7

Cephalopods

Cephalopods

514

0

Totals

Total

9,388,162

100

%

100



Table 2: Place of birth by species (other than non-human primates) (2017)

Animals born in the EU at a registered breeder

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

%

Mammals

Rodents

Mice

5,444,375

204,383

14,171

44,542

5,707,471

60.8

Rats

1,125,076

14,131

1,909

5,183

1,146,299

12.2

Guinea-Pigs

143,202

1,622

0

0

144,824

1.5

Hamsters (Syrian)

11,573

0

9

1,118

12,700

0.1

Hamsters (Chinese)

175

0

0

12

187

0

Mongolian gerbil

4,998

230

0

11

5,239

0.1

Other rodents

9,415

15,104

98

555

25,172

0.3

Rabbits

Rabbits

348,078

2,242

148

1,493

351,961

3.8

Carnivores

Cats

893

828

0

158

1,879

0

Dogs

4,740

4,408

0

4,540

13,688

0.1

Ferrets

1,836

100

24

56

2,016

0

Other carnivores

829

1,550

7

0

2,386

0

Farm animals

Horses, donkeys and cross-breeds

510

1,904

0

0

2,414

0

Pigs

37,465

33,994

54

9

71,522

0.8

Goats

497

1,055

11

0

1,563

0

Sheep

8,069

10,472

271

0

18,812

0.2

Cattle

9,174

21,234

235

0

30,643

0.3

Other mammals

Other mammals

1,855

6,399

4

18,077

26,335

0.3

Birds

Domestic fowl

345,031

119,522

0

0

464,553

5

Other birds

38,965

59,241

563

641

99,410

1.1

Reptiles

Reptiles

53

2,357

259

268

2,937

0

Amphibians

Rana

2,462

1,023

0

0

3,485

0

Xenopus

9,627

598

96

3,218

13,539

0.1

Other amphibians

3,630

6,924

73

56

10,683

0.1

Fish

Zebra fish

467,011

28,081

2,376

2,295

499,763

5.3

Other fish

417,282

224,826

52,644

25,180

719,932

7.7

Cephalopods

Cephalopods

450

60

0

4

514

0

Totals

Total

8,437,271

762,288

72,952

107,416

9,379,927

100

%

90

8.1

0.8

1.1

100



Table 3: Source of non-human primates by species (2017)

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

%

Non-human primates

New World Monkeys

Prosimians

98

0

0

0

0

0

98

1.2

Marmoset and tamarins

377

0

0

0

42

46

465

5.6

Squirrel monkey

5

0

0

2

0

1

8

0.1

Other species of new world monkeys (Ceboidea)

3

0

0

0

0

0

3

0

Old World Monkeys

Cynomolgus monkey

218

5

2,591

0

4,290

123

7,227

87.8

Rhesus monkey

317

0

14

19

3

0

353

4.3

Vervets (Chlorocebus spp.)

0

0

0

33

0

0

33

0.4

Baboons

25

0

0

0

0

0

25

0.3

Other species of old world monkeys (Cercopithecoidea)

14

0

9

0

0

0

23

0.3

Totals

Total

1,057

5

2,614

54

4,335

170

8,235

100

%

12.8

0.1

31.7

0.7

52.6

2.1

100

Table 4: Generation of non-human primates by species (2017)

F0

F1

F2 or greater

Self-sustaining colony

Total

%

Non-human primates

New World Monkeys

Prosimians

0

0

0

98

98

1.2

Marmoset and tamarins

0

0

244

221

465

5.6

Squirrel monkey

0

2

6

0

8

0.1

Other species of new world monkeys (Ceboidea)

0

0

3

0

3

0

Old World Monkeys

Cynomolgus monkey

0

1,335

3,956

1,936

7,227

87.8

Rhesus monkey

0

7

109

237

353

4.3

Vervets (Chlorocebus spp.)

0

14

19

0

33

0.4

Baboons

0

5

8

12

25

0.3

Other species of old world monkeys (Cercopithecoidea)

0

0

23

0

23

0.3

Totals

Total

0

1,363

4,368

2,504

8,235

100

%

0

16.6

53

30.4

100



Part 2: Details of all uses of animals for research, testing, routine production and educational purposes in the EU



Table 5: Uses of animals by species, main categories of scientific purposes and severities (2017)

Severity

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Non-recovery

325,637

41,412

2,526

59

3

0

17,895

0

387,532

6.7

Mild

1,301,419

553,601

533,064

2,536

2,360

13,313

45,524

8

2,451,825

42.6

Moderate

1,161,119

716,532

223,700

15,291

330

39

21,420

0

2,138,431

37.2

Severe

246,193

219,421

280,515

31,664

54

0

486

0

778,333

13.5

Total

3,034,368

1,530,966

1,039,805

49,550

2,747

13,352

85,325

8

5,756,121

100.0

Rats

Non-recovery

66,361

23,448

5,187

1,203

6

0

22,105

0

118,310

10.2

Mild

83,756

86,567

368,165

1,319

127

0

13,407

0

553,341

47.5

Moderate

130,341

109,438

173,627

23

1,004

0

5,582

0

420,015

36.1

Severe

43,573

15,886

11,590

150

1,247

0

55

0

72,501

6.2

Total

324,031

235,339

558,569

2,695

2,384

0

41,149

0

1,164,167

100.0

Guinea-Pigs

Non-recovery

18,948

878

282

266

0

0

265

0

20,639

14.1

Mild

1,352

4,240

63,258

498

10

0

1,619

0

70,977

48.6

Moderate

1,735

2,190

34,927

229

0

0

207

0

39,288

26.9

Severe

140

227

14,765

0

0

0

1

0

15,133

10.4

Total

22,175

7,535

113,232

993

10

0

2,092

0

146,037

100.0

Hamsters (Syrian)

Non-recovery

143

23

0

0

0

0

34

0

200

1.6

Mild

461

1,089

4,314

54

0

0

228

0

6,146

48.3

Moderate

678

1,677

347

34

0

0

5

0

2,741

21.5

Severe

208

1,222

2,149

12

0

0

45

0

3,636

28.6

Total

1,490

4,011

6,810

100

0

0

312

0

12,723

100.0

Hamsters (Chinese)

Non-recovery

0

0

0

0

0

0

5

0

5

2.7

Mild

3

0

59

0

0

0

0

0

62

33.2

Moderate

0

90

0

0

0

0

0

0

90

48.1

Severe

0

30

0

0

0

0

0

0

30

16.0

Total

3

120

59

0

0

0

5

0

187

100.0

Mongolian gerbil

Non-recovery

323

0

0

0

0

0

53

0

376

7.0

Mild

570

911

1,438

81

0

10

49

0

3,059

56.8

Moderate

600

1,074

6

28

0

0

7

0

1,715

31.8

Severe

1

198

36

0

0

0

0

0

235

4.4

Total

1,494

2,183

1,480

109

0

10

109

0

5,385

100.0

Other rodents

Non-recovery

344

15

33

0

1

0

37

0

430

1.7

Mild

13,314

398

9,057

0

53

52

248

0

23,122

90.8

Moderate

821

44

108

0

35

25

0

0

1,033

4.1

Severe

754

7

26

0

80

0

0

0

867

3.4

Total

15,233

464

9,224

0

169

77

285

0

25,452

100.0

Rabbits

Non-recovery

3,256

2,088

12,304

20

0

0

812

0

18,480

5.1

Mild

12,849

3,936

56,131

170,117

316

0

924

0

244,273

67.0

Moderate

3,825

4,826

24,511

57,180

13

0

235

0

90,590

24.9

Severe

3,584

1,011

1,369

5,122

2

0

0

0

11,088

3.0

Total

23,514

11,861

94,315

232,439

331

0

1,971

0

364,431

100.0

Cats

Non-recovery

35

0

0

0

0

0

0

0

35

1.0

Mild

686

1,008

1,087

10

0

0

73

0

2,864

85.8

Moderate

29

114

285

0

0

0

0

0

428

12.8

Severe

0

11

0

0

0

0

0

0

11

0.3

Total

750

1,133

1,372

10

0

0

73

0

3,338

100.0

Dogs

Non-recovery

43

92

89

10

0

0

5

0

239

1.1

Mild

1,347

7,176

6,271

308

15

0

505

0

15,622

73.1

Moderate

229

839

4,072

11

0

0

50

0

5,201

24.4

Severe

4

87

205

1

0

0

0

0

297

1.4

Total

1,623

8,194

10,637

330

15

0

560

0

21,359

100.0

Ferrets

Non-recovery

6

0

0

6

0

0

8

0

20

0.9

Mild

90

526

476

57

0

0

64

0

1,213

57.4

Moderate

218

577

0

0

0

0

0

0

795

37.6

Severe

5

79

0

0

0

0

0

0

84

4.0

Total

319

1,182

476

63

0

0

72

0

2,112

100.0

Other carnivores

Non-recovery

83

0

0

0

0

0

0

0

83

3.3

Mild

213

291

183

20

39

107

0

0

853

33.9

Moderate

580

294

573

0

40

14

0

0

1,501

59.7

Severe

0

33

0

0

44

0

0

0

77

3.1

Total

876

618

756

20

123

121

0

0

2,514

100.0

Horses, donkeys and cross-breeds

Non-recovery

0

17

0

0

0

0

19

0

36

0.3

Mild

1,691

1,484

276

9,575

6

0

268

0

13,300

97.6

Moderate

63

67

44

33

0

0

69

0

276

2.0

Severe

0

2

0

10

0

0

0

0

12

0.1

Total

1,754

1,570

320

9,618

6

0

356

0

13,624

100.0

Pigs

Non-recovery

4,303

2,512

560

47

0

0

7,282

0

14,704

19.4

Mild

8,629

18,424

8,091

401

374

2

1,462

36

37,419

49.3

Moderate

4,420

9,277

3,825

12

234

0

2,283

0

20,051

26.4

Severe

970

2,502

221

0

0

0

8

0

3,701

4.9

Total

18,322

32,715

12,697

460

608

2

11,035

36

75,875

100.0

Goats

Non-recovery

17

110

0

0

0

0

3

0

130

5.7

Mild

817

322

105

44

0

0

184

0

1,472

64.9

Moderate

285

264

12

2

0

0

42

0

605

26.7

Severe

25

32

4

0

0

0

0

0

61

2.7

Total

1,144

728

121

46

0

0

229

0

2,268

100.0

Sheep

Non-recovery

140

403

0

0

0

0

599

0

1,142

1.7

Mild

7,060

5,284

1,076

45,608

105

0

724

88

59,945

91.5

Moderate

1,049

1,950

278

49

14

0

159

0

3,499

5.3

Severe

308

617

8

8

0

0

0

0

941

1.4

Total

8,557

8,254

1,362

45,665

119

0

1,482

88

65,527

100.0

Cattle

Non-recovery

30

2

0

0

0

0

50

0

82

0.2

Mild

14,321

8,436

3,288

595

2,445

0

3,078

26

32,189

86.4

Moderate

439

1,789

468

6

8

0

2,120

0

4,830

13.0

Severe

7

160

1

0

0

0

7

0

175

0.5

Total

14,797

10,387

3,757

601

2,453

0

5,255

26

37,276

100.0

Prosimians

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

87

0

0

0

0

0

0

0

87

50.3

Moderate

86

0

0

0

0

0

0

0

86

49.7

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

173

0

0

0

0

0

0

0

173

100.0

Marmoset and tamarins

Non-recovery

2

2

0

0

0

0

0

0

4

0.6

Mild

107

71

53

86

0

0

1

0

318

49.2

Moderate

73

81

162

0

0

0

0

0

316

48.9

Severe

0

8

0

0

0

0

0

0

8

1.2

Total

182

162

215

86

0

0

1

0

646

100.0

Squirrel monkey

Non-recovery

6

0

0

0

0

0

0

0

6

75.0

Mild

0

0

0

0

0

0

0

0

0

0.0

Moderate

1

1

0

0

0

0

0

0

2

25.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

7

1

0

0

0

0

0

0

8

100.0

Other species of new world monkeys (Ceboidea)

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

3

0

0

0

0

0

0

0

3

100.0

Moderate

0

0

0

0

0

0

0

0

0

0.0

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

3

0

0

0

0

0

0

0

3

100.0

Cynomolgus monkey

Non-recovery

11

8

0

4

0

0

3

0

26

0.3

Mild

302

711

3,437

1,049

0

0

8

0

5,507

55.0

Moderate

216

307

3,780

0

0

0

6

0

4,309

43.1

Severe

0

99

66

0

0

0

0

0

165

1.6

Total

529

1,125

7,283

1,053

0

0

17

0

10,007

100.0

Rhesus monkey

Non-recovery

21

1

0

0

0

0

0

0

22

3.5

Mild

81

162

11

29

0

0

4

0

287

45.7

Moderate

143

169

0

0

0

0

0

0

312

49.7

Severe

5

2

0

0

0

0

0

0

7

1.1

Total

250

334

11

29

0

0

4

0

628

100.0

Vervets (Chlorocebus spp.)

Non-recovery

11

0

0

0

0

0

0

0

11

20.8

Mild

11

15

0

5

0

0

0

0

31

58.5

Moderate

0

11

0

0

0

0

0

0

11

20.8

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

22

26

0

5

0

0

0

0

53

100.0

Baboons

Non-recovery

0

1

0

0

0

0

0

0

1

2.2

Mild

10

10

0

0

0

0

0

0

20

43.5

Moderate

0

19

0

0

0

0

0

0

19

41.3

Severe

0

6

0

0

0

0

0

0

6

13.0

Total

10

36

0

0

0

0

0

0

46

100.0

Other species of old world monkeys (Cercopithecoidea)

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

14

12

0

0

0

0

0

0

26

74.3

Moderate

0

9

0

0

0

0

0

0

9

25.7

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

14

21

0

0

0

0

0

0

35

100.0

Other mammals

Non-recovery

60

0

0

0

0

0

0

0

60

0.2

Mild

4,074

21,523

0

1

71

274

121

0

26,064

96.3

Moderate

893

7

0

0

0

0

0

0

900

3.3

Severe

9

10

0

0

23

0

0

0

42

0.2

Total

5,036

21,540

0

1

94

274

121

0

27,066

100.0

Domestic fowl

Non-recovery

5,886

839

261

189

0

0

387

0

7,562

1.6

Mild

70,751

81,809

112,004

87,000

2,406

343

1,705

315

356,333

75.5

Moderate

30,401

15,663

29,352

15,089

353

0

2,120

0

92,978

19.7

Severe

1,347

8,712

4,871

127

0

0

82

0

15,139

3.2

Total

108,385

107,023

146,488

102,405

2,759

343

4,294

315

472,012

100.0

Other birds

Non-recovery

625

671

0

0

0

0

54

0

1,350

1.3

Mild

49,265

10,880

4,288

303

2,567

690

464

0

68,457

66.9

Moderate

7,187

805

563

22,518

0

6

172

0

31,251

30.5

Severe

279

736

153

0

0

0

120

0

1,288

1.3

Total

57,356

13,092

5,004

22,821

2,567

696

810

0

102,346

100.0

Reptiles

Non-recovery

237

18

0

0

0

0

0

0

255

3.9

Mild

1,912

63

0

0

8

70

100

0

2,153

32.8

Moderate

4,118

36

0

0

0

0

0

0

4,154

63.3

Severe

0

0

0

0

0

0

0

0

0

0.0

Total

6,267

117

0

0

8

70

100

0

6,562

100.0

Rana

Non-recovery

0

0

0

0

0

0

138

0

138

3.9

Mild

290

0

0

0

0

0

257

0

547

15.6

Moderate

400

108

0

0

200

0

1,906

0

2,614

74.7

Severe

108

0

91

0

0

0

0

0

199

5.7

Total

798

108

91

0

200

0

2,301

0

3,498

100.0

Xenopus

Non-recovery

1,268

0

0

0

0

0

257

0

1,525

7.1

Mild

12,845

3,530

0

0

2

0

107

0

16,484

76.9

Moderate

650

116

0

210

900

0

38

0

1,914

8.9

Severe

867

0

653

0

0

0

0

0

1,520

7.1

Total

15,630

3,646

653

210

902

0

402

0

21,443

100.0

Other amphibians

Non-recovery

95

336

0

0

1,565

0

190

0

2,186

20.0

Mild

3,401

623

0

0

246

336

15

0

4,621

42.2

Moderate

2,691

60

0

0

0

62

0

0

2,813

25.7

Severe

1,235

32

59

0

0

0

0

0

1,326

12.1

Total

7,422

1,051

59

0

1,811

398

205

0

10,946

100.0

Zebra fish

Non-recovery

19,020

400

188

0

2

0

296

0

19,906

3.9

Mild

288,687

69,735

13,369

0

2,414

140

1,344

0

375,689

74.5

Moderate

39,965

26,291

14,892

0

0

0

41

0

81,189

16.1

Severe

6,664

3,811

16,924

0

0

0

0

0

27,399

5.4

Total

354,336

100,237

45,373

0

2,416

140

1,681

0

504,183

100.0

Other fish

Non-recovery

17,181

3,788

4

0

1,649

2,245

692

0

25,559

3.5

Mild

244,988

35,901

99,525

49

54,888

52,866

2,695

0

490,912

67.9

Moderate

41,294

17,304

8,144

0

42,704

8,286

125

0

117,857

16.3

Severe

27,298

36,729

19,017

0

5,791

13

0

0

88,848

12.3

Total

330,761

93,722

126,690

49

105,032

63,410

3,512

0

723,176

100.0

Cephalopods

Non-recovery

0

0

0

0

0

0

0

0

0

0.0

Mild

22

450

0

0

24

0

4

0

500

97.3

Moderate

0

5

0

0

0

0

0

0

5

1.0

Severe

0

0

0

0

9

0

0

0

9

1.8

Total

22

455

0

0

33

0

4

0

514

100.0

All Species

Non-recovery

464,092

77,064

21,434

1,804

3,226

2,245

51,189

0

621,054

6.5

Mild

2,125,428

919,188

1,289,026

319,745

68,476

68,203

75,182

473

4,865,721

50.8

Moderate

1,434,549

912,034

523,676

110,715

45,835

8,432

36,587

0

3,071,828

32.1

Severe

333,584

291,670

352,723

37,094

7,250

13

804

0

1,023,138

10.7

Total

4,357,653

2,199,956

2,186,859

469,358

124,787

78,893

163,762

473

9,581,741

100.0



Table 5.1: Uses of animals in all sub-categories of research and testing by severities (2017)

Non-recovery

Mild

Moderate

Severe

Total

%

Basic research

Oncology

30,689

229,180

296,237

56,238

612,344

6.4

Cardiovascular Blood and Lymphatic System

60,428

131,992

101,476

17,780

311,676

3.3

Nervous System

105,674

433,216

342,511

87,874

969,275

10.1

Respiratory System

8,594

27,781

30,959

6,612

73,946

0.8

Gastrointestinal System including Liver

16,627

52,466

49,801

10,699

129,593

1.4

Musculoskeletal System

4,388

42,345

35,170

8,500

90,403

0.9

Immune System

57,067

365,100

250,156

74,584

746,907

7.8

Urogenital/Reproductive System

9,048

57,656

27,085

1,686

95,475

1

Sensory Organs (skin, eyes and ears)

7,430

39,000

16,115

2,956

65,501

0.7

Endocrine System/Metabolism

21,328

101,642

71,957

20,285

215,212

2.2

Multisystemic

11,865

127,470

65,864

10,063

215,262

2.2

Ethology / Animal Behaviour /Animal Biology

6,499

356,298

83,480

9,198

455,475

4.8

Other basic research

124,455

161,282

63,738

27,109

376,584

3.9

Translational and applied research

Human Cancer

4,005

198,550

342,158

39,888

584,601

6.1

Human Infectious Disorders

3,508

156,726

80,143

31,470

271,847

2.8

Human Cardiovascular Disorders

14,250

21,383

29,194

4,779

69,606

0.7

Human Nervous and Mental Disorders

13,728

127,972

136,480

27,602

305,782

3.2

Human Respiratory Disorders

4,340

28,926

30,002

4,127

67,395

0.7

Human Gastrointestinal Disorders including Liver

1,823

15,014

27,091

4,702

48,630

0.5

Human Musculoskeletal Disorders

3,276

10,966

17,835

6,238

38,315

0.4

Human Immune Disorders

3,390

25,176

30,471

16,305

75,342

0.8

Human Urogenital/Reproductive Disorders

1,715

6,603

7,801

1,050

17,169

0.2

Human Sensory Organ Disorders (skin, eyes and ears)

1,012

31,072

20,000

757

52,841

0.6

Human Endocrine/Metabolism Disorders

4,515

39,634

51,836

4,678

100,663

1.1

Other Human Disorders

8,802

9,395

17,927

6,530

42,654

0.4

Animal Diseases and Disorders

3,809

112,447

47,606

52,859

216,721

2.3

Animal Welfare

2,313

51,656

4,452

3,946

62,367

0.7

Diagnosis of diseases

3,580

25,417

39,451

81,239

149,687

1.6

Plant diseases

0

87

89

0

176

0

Non-regulatory toxicology and ecotoxicology

2,998

58,164

29,498

5,500

96,160

1

Regulatory use

Quality control (incl batch safety and potency testing)

Batch safety testing

0

120,743

12,381

6,478

139,602

1.5

Pyrogenicity testing

80

18,070

16,716

306

35,172

0.4

Batch potency testing

13,658

382,887

231,545

264,633

892,723

9.3

Other quality controls

343

44,827

14,060

4,853

64,083

0.7

Toxicity and other safety testing including pharmacology

Acute and sub-acute toxicity testing methods

LD50, LC50

0

28,599

5,188

13,152

46,939

0.5

Other lethal methods

0

498

3,519

1,231

5,248

0.1

Non lethal methods

0

17,791

12,557

870

31,218

0.3

Skin irritation/corrosion

0

3,267

825

28

4,120

0

Skin sensitisation

0

41,502

5,490

349

47,341

0.5

Eye irritation/corrosion

0

320

473

21

814

0

Repeated dose toxicity

up to 28 days

0

34,793

23,635

2,916

61,344

0.6

29 - 90 days

110

20,248

14,281

292

34,931

0.4

> 90 days

0

11,808

6,088

402

18,298

0.2

Carcinogenicity

100

6,200

5,871

322

12,493

0.1

Genotoxicity

125

8,337

1,509

332

10,303

0.1

Reproductive toxicity

0

105,468

31,161

3,884

140,513

1.5

Developmental toxicity

0

66,352

18,792

12,527

97,671

1

Neurotoxicity

0

1,934

193

642

2,769

0

Kinetics

244

43,187

25,315

627

69,373

0.7

Pharmaco-dynamics (incl safety pharmacology)

5,235

57,740

32,878

3,500

99,353

1

Phototoxicity

0

353

142

30

525

0

Ecotoxicity

Acute toxicity

188

25,364

2,934

16,429

44,915

0.5

Chronic toxicity

0

8,855

17,709

2,174

28,738

0.3

Reproductive ecotoxicity

0

546

904

0

1,450

0

Endocrine activity

0

5,724

0

200

5,924

0.1

Bioaccumulation

0

2,796

540

774

4,110

0

Other ecotoxicity

33

8,705

18

454

9,210

0.1

Safety testing in food and feed area

0

34,115

703

10,982

45,800

0.5

Target animal safety

4

7,357

1,272

84

8,717

0.1

Other toxicity/safety testing

4

6,906

3,837

511

11,258

0.1

Other efficacy and tolerance testing

Other efficacy and tolerance testing

1,310

173,734

33,140

3,720

211,904

2.2

Routine production

Blood based products

1,585

202,172

55,736

287

259,780

2.7

Monoclonal antibody by mouse ascites method

0

892

12,468

31,664

45,024

0.5

Other product types

219

116,681

42,511

5,143

164,554

1.7

Other

Protection of the natural environment in the interests of the health or welfare of human beings or animals

3,226

68,476

45,835

7,250

124,787

1.3

Preservation of species

2,245

68,203

8,432

13

78,893

0.8

Higher education or training for the acquisition, maintenance or improvement of vocational skills

51,189

75,182

36,587

804

163,762

1.7

Forensic enquiries

0

473

0

0

473

0

Total

621,054

4,865,721

3,071,828

1,023,138

9,581,741

100

%

6.5

50.8

32.1

10.7

100



Table 6: Basic research related uses by species and type of research (2017)

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

%

Mammals

Rodents

Mice

527,825

239,271

684,862

64,452

97,905

68,564

660,554

80,681

52,436

161,545

156,029

17,344

222,900

3,034,368

69.6

Rats

6,004

41,095

146,460

5,846

13,624

6,040

10,819

6,350

5,775

31,344

12,564

15,209

22,901

324,031

7.4

Guinea-Pigs

54

499

562

1,275

5

24

163

4

572

137

7

50

18,823

22,175

0.5

Hamsters (Syrian)

100

0

153

0

136

0

198

0

0

168

274

23

438

1,490

0

Hamsters (Chinese)

0

0

0

0

0

0

0

0

3

0

0

0

0

3

0

Mongolian gerbil

0

76

627

0

9

11

262

0

265

0

0

41

203

1,494

0

Other rodents

127

0

693

90

0

0

1,561

20

153

284

111

5,234

6,960

15,233

0.3

Rabbits

Rabbits

162

1,371

226

868

149

456

607

715

579

1,642

269

8,367

8,103

23,514

0.5

Carnivores

Cats

0

0

70

0

24

5

0

0

8

49

303

0

291

750

0

Dogs

8

143

53

0

67

225

100

97

49

31

105

54

691

1,623

0

Ferrets

0

0

249

62

4

0

4

0

0

0

0

0

0

319

0

Other carnivores

0

4

0

0

78

0

521

0

0

0

0

263

10

876

0

Farm animals

Horses, donkeys and cross-breeds

0

55

0

48

9

185

411

251

0

567

4

88

136

1,754

0

Pigs

57

1,899

635

285

4,809

346

1,628

446

109

1,940

1,303

3,025

1,840

18,322

0.4

Goats

0

14

0

0

17

8

117

141

0

158

0

574

115

1,144

0

Sheep

24

431

66

17

544

1,020

1,414

438

0

422

110

2,104

1,967

8,557

0.2

Cattle

0

55

30

95

1,188

4

6,006

1,066

17

1,351

1,061

2,790

1,134

14,797

0.3

Non-human primates

Prosimians

0

0

4

0

0

0

0

0

0

82

0

87

0

173

0

Marmoset and tamarins

1

0

51

0

0

0

0

12

0

24

6

46

42

182

0

Squirrel monkey

0

0

7

0

0

0

0

0

0

0

0

0

0

7

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

3

0

3

0

Cynomolgus monkey

0

40

144

35

0

2

9

0

6

4

7

0

282

529

0

Rhesus monkey

0

51

116

0

0

0

24

0

0

0

32

0

27

250

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

11

0

0

0

0

0

11

22

0

Baboons

0

0

0

0

0

0

10

0

0

0

0

0

0

10

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

14

0

14

0

Other mammals

Other mammals

0

9

228

0

11

1

0

22

28

0

89

4,427

221

5,036

0.1

Birds

Domestic fowl

785

248

3,211

0

6,559

102

7,123

392

138

4,352

2,210

70,390

12,875

108,385

2.5

Other birds

0

234

549

0

43

33

106

79

1

439

10

53,443

2,419

57,356

1.3

Reptiles

Reptiles

0

110

260

0

0

10

0

0

3

43

0

5,756

85

6,267

0.1

Amphibians

Rana

0

0

400

0

0

0

0

0

0

0

0

112

286

798

0

Xenopus

822

390

4,365

3

0

848

0

1,417

356

39

1,584

39

5,767

15,630

0.4

Other amphibians

0

0

1,117

0

0

1,092

7

27

0

240

33

4,118

788

7,422

0.2

Fish

Zebra fish

76,185

25,098

122,697

0

3,017

10,817

18,659

2,818

4,456

6,641

35,347

12,400

36,201

354,336

8.1

Other fish

190

583

1,434

870

1,395

610

36,593

499

547

3,710

3,804

249,458

31,068

330,761

7.6

Cephalopods

Cephalopods

0

0

6

0

0

0

0

0

0

0

0

16

0

22

0

Totals

Total

612,344

311,676

969,275

73,946

129,593

90,403

746,907

95,475

65,501

215,212

215,262

455,475

376,584

4,357,653

100

%

14.1

7.2

22.2

1.7

3

2.1

17.1

2.2

1.5

4.9

4.9

10.5

8.6

100

Table 7.1: Translational and applied research related uses by species and type of research (Part 1) (2017)

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Mammals

Rodents

Mice

575,924

201,086

41,449

194,708

47,685

36,526

24,908

70,565

11,299

Rats

5,442

5,236

21,612

87,139

15,302

9,425

9,634

3,960

4,960

Guinea-Pigs

66

1,391

619

276

2,486

14

0

287

0

Hamsters (Syrian)

213

1,708

27

197

0

0

0

0

0

Hamsters (Chinese)

0

0

0

0

0

0

0

0

0

Mongolian gerbil

0

1,453

0

118

0

0

0

0

0

Other rodents

0

320

0

0

82

0

0

30

0

Rabbits

Rabbits

1,927

1,140

913

181

862

59

779

319

162

Carnivores

Cats

0

0

0

0

0

0

0

0

0

Dogs

12

30

160

134

59

18

118

60

0

Ferrets

0

995

0

0

0

96

0

0

0

Other carnivores

0

0

0

0

0

0

0

0

0

Farm animals

Horses, donkeys and cross-breeds

0

395

0

0

0

6

7

3

0

Pigs

266

235

3,382

431

646

2,311

214

68

485

Goats

7

18

30

2

0

0

21

0

1

Sheep

16

183

863

181

79

0

547

0

203

Cattle

12

40

6

0

45

6

0

0

0

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

3

87

0

59

0

0

0

11

0

Squirrel monkey

0

1

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

26

319

36

139

23

12

0

30

54

Rhesus monkey

0

328

0

4

0

0

0

0

2

Vervets (Chlorocebus spp.)

0

26

0

0

0

0

0

0

0

Baboons

0

19

14

0

0

0

0

0

3

Other species of old world monkeys (Cercopithecoidea)

0

12

0

0

0

0

0

0

0

Other mammals

Other mammals

31

18,217

19

0

8

0

0

2

0

Birds

Domestic fowl

33

751

72

2

118

157

0

7

0

Other birds

0

5,202

4

0

0

0

0

0

0

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

Xenopus

185

0

0

25

0

0

0

0

0

Other amphibians

0

0

0

0

0

0

0

0

0

Fish

Zebra fish

438

32,655

400

22,186

0

0

2,087

0

0

Other fish

0

0

0

0

0

0

0

0

0

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

Totals

Total

584,601

271,847

69,606

305,782

67,395

48,630

38,315

75,342

17,169

%

26.6

12.4

3.2

13.9

3.1

2.2

1.7

3.4

0.8



Table 7.2: Translational and applied research related uses by species and type of research (Part 2) (2017)

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

%

Mammals

Rodents

Mice

43,473

68,703

24,626

30,449

1,063

139,893

119

18,490

1,530,966

69.6

Rats

5,851

25,865

17,111

1,605

613

3,928

25

17,631

235,339

10.7

Guinea-Pigs

373

62

101

900

9

473

0

478

7,535

0.3

Hamsters (Syrian)

0

677

17

1,172

0

0

0

0

4,011

0.2

Hamsters (Chinese)

0

0

0

120

0

0

0

0

120

0

Mongolian gerbil

0

0

0

612

0

0

0

0

2,183

0.1

Other rodents

0

0

0

17

0

0

0

15

464

0

Rabbits

Rabbits

1,017

241

300

2,697

133

858

32

241

11,861

0.5

Carnivores

Cats

0

0

0

1,057

0

70

0

6

1,133

0.1

Dogs

30

81

49

5,029

84

264

0

2,066

8,194

0.4

Ferrets

0

0

4

82

0

5

0

0

1,182

0.1

Other carnivores

0

0

0

364

254

0

0

0

618

0

Farm animals

Horses, donkeys and cross-breeds

0

0

0

1,025

51

83

0

0

1,570

0.1

Pigs

401

1,032

232

14,915

7,530

326

0

241

32,715

1.5

Goats

0

0

0

394

178

77

0

0

728

0

Sheep

0

56

176

2,968

1,954

995

0

33

8,254

0.4

Cattle

0

182

0

7,134

2,878

67

0

17

10,387

0.5

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

2

0

0

0

0

0

0

0

162

0

Squirrel monkey

0

0

0

0

0

0

0

0

1

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

43

52

16

0

0

0

0

375

1,125

0.1

Rhesus monkey

0

0

0

0

0

0

0

0

334

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

26

0

Baboons

0

0

0

0

0

0

0

0

36

0

Other species of old world monkeys (Cercopithecoidea)

0

0

9

0

0

0

0

0

21

0

Other mammals

Other mammals

0

3

0

29

3,201

30

0

0

21,540

1

Birds

Domestic fowl

0

0

0

77,727

25,183

1,746

0

1,227

107,023

4.9

Other birds

0

0

0

5,791

1,345

222

0

528

13,092

0.6

Reptiles

Reptiles

0

0

0

56

61

0

0

0

117

0

Amphibians

Rana

0

0

0

0

0

0

0

108

108

0

Xenopus

0

21

0

0

0

0

0

3,415

3,646

0.2

Other amphibians

0

0

11

200

0

0

0

840

1,051

0

Fish

Zebra fish

1,651

3,543

2

787

0

0

0

36,488

100,237

4.6

Other fish

0

145

0

61,586

17,380

650

0

13,961

93,722

4.3

Cephalopods

Cephalopods

0

0

0

5

450

0

0

0

455

0

Totals

Total

52,841

100,663

42,654

216,721

62,367

149,687

176

96,160

2,199,956

100

%

2.4

4.6

1.9

9.9

2.8

6.8

0

4.4

100



Table 8: Regulatory uses by species and type of use (2017)

Quality

Toxicity

Other

Quality: Batch safety testing

Quality: Pyrogenicity testing

Quality: Batch potency testing

Quality: Other quality controls

Toxicity and other safety testing including pharmacology

Other efficacy and tolerance testing

Total

%

Mammals

Rodents

Mice

82,331

0

594,913

40,267

245,984

76,310

1,039,805

47.5

Rats

4,287

0

157,176

1,717

386,969

8,420

558,569

25.5

Guinea-Pigs

16,612

0

62,104

1,097

32,530

889

113,232

5.2

Hamsters (Syrian)

20

0

3,826

2,285

383

296

6,810

0.3

Hamsters (Chinese)

0

0

0

0

59

0

59

0

Mongolian gerbil

0

0

0

0

1,421

59

1,480

0.1

Other rodents

104

0

0

0

9,060

60

9,224

0.4

Rabbits

Rabbits

1,257

35,172

22,318

2,121

30,864

2,583

94,315

4.3

Carnivores

Cats

33

0

121

110

772

336

1,372

0.1

Dogs

307

0

58

328

8,845

1,099

10,637

0.5

Ferrets

192

0

250

0

34

0

476

0

Other carnivores

359

0

310

0

81

6

756

0

Farm animals

Horses, donkeys and cross-breeds

2

0

0

0

71

247

320

0

Pigs

1,354

0

2,158

690

4,672

3,823

12,697

0.6

Goats

0

0

12

0

75

34

121

0

Sheep

271

0

445

91

313

242

1,362

0.1

Cattle

449

0

1,065

33

1,078

1,132

3,757

0.2

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

0

0

215

0

215

0

Squirrel monkey

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

0

0

7,191

92

7,283

0.3

Rhesus monkey

0

0

0

8

3

0

11

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

Birds

Domestic fowl

31,808

0

43,316

14,479

14,058

42,827

146,488

6.7

Other birds

180

0

728

673

974

2,449

5,004

0.2

Reptiles

Reptiles

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

91

0

91

0

Xenopus

0

0

0

0

653

0

653

0

Other amphibians

0

0

0

0

59

0

59

0

Fish

Zebra fish

0

0

0

84

45,289

0

45,373

2.1

Other fish

36

0

3,923

100

51,631

71,000

126,690

5.8

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

Totals

Total

139,602

35,172

892,723

64,083

843,375

211,904

2,186,859

100

%

6.4

1.6

40.8

2.9

38.6

9.7

100



Table 9.1: Toxicity and other safety testing including pharmacology by species and type of use (Part 1) (2017)

Acute

Repeated Dose

LD50, LC50

Other lethal methods

Non lethal methods

Skin irritation / corrosion

Skin sensitisation

Eye irritation / corrosion

up to 28 days

29 - 90 days

> 90 days

Carcinogenicity

Genotoxicity

Developmental toxicity

Safety testing in food and feed area

Mammals

Rodents

Mice

30,521

666

11,694

28

16,478

0

13,621

7,359

1,783

5,971

4,236

977

40,556

Rats

5,006

1,042

16,778

244

0

0

40,791

23,460

13,522

6,522

6,067

70,778

0

Guinea-Pigs

40

0

543

0

30,785

0

92

92

0

0

0

0

0

Hamsters (Syrian)

0

0

225

84

0

0

6

0

0

0

0

0

0

Hamsters (Chinese)

0

0

0

47

0

0

0

0

0

0

0

0

0

Mongolian gerbil

0

0

0

0

0

0

0

0

0

0

0

0

0

Other rodents

0

0

6

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

10

776

3,691

68

814

1,354

834

270

0

0

14,910

0

Carnivores

Cats

0

0

0

0

0

0

28

0

30

0

0

0

0

Dogs

0

0

703

0

0

0

2,567

1,277

1,272

0

0

88

0

Ferrets

0

0

0

0

0

0

0

0

0

0

0

0

0

Other carnivores

0

0

0

0

0

0

0

0

0

0

0

0

0

Farm animals

Horses, donkeys and cross-breeds

0

0

0

0

0

0

0

0

0

0

0

0

0

Pigs

0

0

76

26

10

0

774

287

323

0

0

0

41

Goats

0

0

0

0

0

0

0

0

0

0

0

0

4

Sheep

0

0

0

0

0

0

0

0

0

0

0

0

144

Cattle

0

0

0

0

0

0

0

0

0

0

0

0

145

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

0

0

0

0

129

46

3

0

0

0

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

311

0

0

0

1,979

1,576

1,095

0

0

264

0

Rhesus monkey

0

0

0

0

0

0

3

0

0

0

0

0

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

5,555

0

0

0

0

0

0

0

0

0

0

0

4,437

Other birds

162

0

62

0

0

0

0

0

0

0

0

0

53

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

0

0

0

0

0

0

0

0

Xenopus

0

0

0

0

0

0

0

0

0

0

0

0

0

Other amphibians

0

0

0

0

0

0

0

0

0

0

0

0

0

Fish

Zebra fish

475

3,530

44

0

0

0

0

0

0

0

0

9,774

0

Other fish

5,180

0

0

0

0

0

0

0

0

0

0

880

420

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

46,939

5,248

31,218

4,120

47,341

814

61,344

34,931

18,298

12,493

10,303

97,671

45,800

%

5.6

0.6

3.7

0.5

5.6

0.1

7.3

4.1

2.2

1.5

1.2

11.6

5.4

Table 9.2: Toxicity and other safety testing including pharmacology by species and type of use (Part 2) (2017)

EcoToxicity

Target animal safety

Neurotoxicity

Kinetics

Pharmaco - dynamics (incl safety pharmacology)

Phototoxicity

Acute toxicity

Chronic toxicity

Reproductive toxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Other toxicity / safety testing

Total

%

Mammals

Rodents

Mice

549

332

36,480

57,482

440

9,764

50

1,762

0

0

447

4,788

245,984

29.2

Rats

33

420

26,659

36,615

85

1,035

1,107

132,639

0

0

0

3,652

386,455

45.9

Guinea-Pigs

0

0

110

506

0

138

0

0

0

0

142

82

32,530

3.9

Hamsters (Syrian)

0

0

0

68

0

0

0

0

0

0

0

0

383

0

Hamsters (Chinese)

0

0

12

0

0

0

0

0

0

0

0

0

59

0

Mongolian gerbil

0

0

66

1,355

0

0

0

0

0

0

0

0

1,421

0.2

Other rodents

2,500

0

0

0

0

0

0

0

0

0

6,554

0

9,060

1.1

Rabbits

Rabbits

121

0

539

1,141

0

0

86

5,097

0

0

0

1,121

30,832

3.7

Carnivores

Cats

167

0

424

123

0

0

0

0

0

0

0

0

772

0.1

Dogs

112

0

1,728

976

0

0

0

0

0

0

0

122

8,845

1.1

Ferrets

34

0

0

0

0

0

0

0

0

0

0

0

34

0

Other carnivores

81

0

0

0

0

0

0

0

0

0

0

0

81

0

Farm animals

Horses, donkeys and cross-breeds

8

0

42

5

0

0

0

0

0

0

16

0

71

0

Pigs

891

0

1,121

423

0

0

0

0

0

0

0

700

4,672

0.6

Goats

0

0

23

48

0

0

0

0

0

0

0

0

75

0

Sheep

124

0

26

0

0

0

0

0

0

0

0

19

313

0

Cattle

288

0

184

357

0

0

0

0

0

72

20

12

1,078

0.1

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

0

0

16

0

0

0

0

0

0

0

0

21

215

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

1,414

254

0

0

0

0

0

0

0

298

7,191

0.9

Rhesus monkey

0

0

0

0

0

0

0

0

0

0

0

0

3

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

3,385

0

361

0

0

12

0

0

0

0

0

308

14,058

1.7

Other birds

200

0

168

0

0

27

0

128

0

0

39

135

974

0.1

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

91

0

0

0

0

0

0

91

0

Xenopus

0

0

0

0

0

128

0

0

0

525

0

0

653

0.1

Other amphibians

0

0

0

0

0

59

0

0

0

0

0

0

59

0

Fish

Zebra fish

0

2,017

0

0

0

9,458

12,497

887

5,040

369

294

0

44,385

5.3

Other fish

224

0

0

0

0

24,203

14,998

0

884

3,144

1,698

0

51,631

6.1

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

8,717

2,769

69,373

99,353

525

44,915

28,738

140,513

5,924

4,110

9,210

11,258

841,925

100

%

1

0.3

8.2

11.8

0.1

5.3

3.4

16.7

0.7

0.5

1.1

1.3

100

Table 10: Regulatory uses by species and type of legislation (2017)

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Other legislation

Total

%

Mammals

Rodents

Mice

839,113

121,753

18,850

8,752

7,545

826

41,515

889

562

1,039,805

47.5

Rats

317,250

17,220

3,879

182,624

29,679

1,011

2,641

3,211

1,054

558,569

25.5

Guinea-Pigs

69,557

15,199

26,208

2,080

89

73

0

0

26

113,232

5.2

Hamsters (Syrian)

542

5,916

346

0

0

6

0

0

0

6,810

0.3

Hamsters (Chinese)

0

0

47

12

0

0

0

0

0

59

0

Mongolian gerbil

0

1,480

0

0

0

0

0

0

0

1,480

0.1

Other rodents

104

0

0

0

9,054

6

0

0

60

9,224

0.4

Rabbits

Rabbits

63,997

10,828

4,862

10,648

2,697

263

18

24

978

94,315

4.3

Carnivores

Cats

24

1,348

0

0

0

0

0

0

0

1,372

0.1

Dogs

8,343

2,093

31

20

136

0

0

0

14

10,637

0.5

Ferrets

442

34

0

0

0

0

0

0

0

476

0

Other carnivores

0

756

0

0

0

0

0

0

0

756

0

Farm animals

Horses, donkeys and cross-breeds

38

261

0

0

0

0

0

21

0

320

0

Pigs

3,456

8,464

214

3

0

0

0

557

3

12,697

0.6

Goats

12

78

4

0

27

0

0

0

0

121

0

Sheep

39

1,118

79

0

0

0

99

27

0

1,362

0.1

Cattle

0

3,570

0

0

44

0

0

143

0

3,757

0.2

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

Marmoset and tamarins

215

0

0

0

0

0

0

0

0

215

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

7,283

0

0

0

0

0

0

0

0

7,283

0.3

Rhesus monkey

3

0

8

0

0

0

0

0

0

11

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

2,398

126,181

0

0

391

0

0

17,498

20

146,488

6.7

Other birds

130

4,213

0

10

278

0

0

373

0

5,004

0.2

Reptiles

Reptiles

0

0

0

0

0

0

0

0

0

0

0

Amphibians

Rana

0

0

0

0

91

0

0

0

0

91

0

Xenopus

0

0

0

525

128

0

0

0

0

653

0

Other amphibians

0

0

0

0

59

0

0

0

0

59

0

Fish

Zebra fish

9,158

209

3,250

14,142

10,004

1,620

0

145

6,845

45,373

2.1

Other fish

6,844

4,765

534

11,361

14,983

324

0

71,627

16,252

126,690

5.8

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

0

0

0

Totals

Total

1,328,948

325,486

58,312

230,177

75,205

4,129

44,273

94,515

25,814

2,186,859

100

%

60.8

14.9

2.7

10.5

3.4

0.2

2

4.3

1.2

100

Table 11: Regulatory uses by species and origin of regulatory requirement (2017)

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

%

Mammals

Rodents

Mice

987,608

8,465

43,732

1,039,805

47.5

Rats

552,596

1,812

4,161

558,569

25.5

Guinea-Pigs

106,808

1,244

5,180

113,232

5.2

Hamsters (Syrian)

6,140

0

670

6,810

0.3

Hamsters (Chinese)

59

0

0

59

0

Mongolian gerbil

1,480

0

0

1,480

0.1

Other rodents

9,158

66

0

9,224

0.4

Rabbits

Rabbits

73,568

61

20,686

94,315

4.3

Carnivores

Cats

1,372

0

0

1,372

0.1

Dogs

10,579

12

46

10,637

0.5

Ferrets

476

0

0

476

0

Other carnivores

756

0

0

756

0

Farm animals

Horses, donkeys and cross-breeds

320

0

0

320

0

Pigs

11,350

0

1,347

12,697

0.6

Goats

121

0

0

121

0

Sheep

1,356

0

6

1,362

0.1

Cattle

3,717

32

8

3,757

0.2

Non-human primates

Prosimians

0

0

0

0

0

Marmoset and tamarins

215

0

0

215

0

Squirrel monkey

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

Cynomolgus monkey

7,107

131

45

7,283

0.3

Rhesus monkey

11

0

0

11

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

Baboons

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

Birds

Domestic fowl

140,752

35

5,701

146,488

6.7

Other birds

4,989

0

15

5,004

0.2

Reptiles

Reptiles

0

0

0

0

0

Amphibians

Rana

91

0

0

91

0

Xenopus

653

0

0

653

0

Other amphibians

59

0

0

59

0

Fish

Zebra fish

44,123

1,250

0

45,373

2.1

Other fish

115,618

9,774

1,298

126,690

5.8

Cephalopods

Cephalopods

0

0

0

0

0

Totals

Total

2,081,082

22,882

82,895

2,186,859

100

%

95.2

1

3.8

100



Table 12: Routine production uses by species and product type (2017)

Blood based products

Other product types

Monoclonal antibody by mouse ascites method

Total

%

Mammals

Rodents

Mice

1,623

3,353

44,574

49,550

10.6

Rats

2,437

225

33

2,695

0.6

Guinea-Pigs

954

39

0

993

0.2

Hamsters (Syrian)

0

100

0

100

0

Hamsters (Chinese)

0

0

0

0

0

Mongolian gerbil

0

109

0

109

0

Other rodents

0

0

0

0

0

Rabbits

Rabbits

196,761

35,261

417

232,439

49.5

Carnivores

Cats

0

10

0

10

0

Dogs

274

56

0

330

0.1

Ferrets

37

26

0

63

0

Other carnivores

20

0

0

20

0

Farm animals

Horses, donkeys and cross-breeds

9,577

41

0

9,618

2

Pigs

17

443

0

460

0.1

Goats

45

1

0

46

0

Sheep

44,308

1,357

0

45,665

9.7

Cattle

375

226

0

601

0.1

Non-human primates

Prosimians

0

0

0

0

0

Marmoset and tamarins

86

0

0

86

0

Squirrel monkey

0

0

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

Cynomolgus monkey

854

199

0

1,053

0.2

Rhesus monkey

29

0

0

29

0

Vervets (Chlorocebus spp.)

5

0

0

5

0

Baboons

0

0

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

Other mammals

Other mammals

0

1

0

1

0

Birds

Domestic fowl

2,345

100,060

0

102,405

21.8

Other birds

33

22,788

0

22,821

4.9

Reptiles

Reptiles

0

0

0

0

0

Amphibians

Rana

0

0

0

0

0

Xenopus

0

210

0

210

0

Other amphibians

0

0

0

0

0

Fish

Zebra fish

0

0

0

0

0

Other fish

0

49

0

49

0

Cephalopods

Cephalopods

0

0

0

0

0

Totals

Total

259,780

164,554

45,024

469,358

100

%

55.3

35.1

9.6

100



Table 13: Reuses of animals by species and main categories of scientific purposes in research, testing routine production and education (2017)

Reuse

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Yes

20,981

11,335

11,544

412

0

7

4,371

0

48,650

0.8

No

3,013,387

1,519,631

1,028,261

49,138

2,747

13,345

80,954

8

5,707,471

99.2

Total

3,034,368

1,530,966

1,039,805

49,550

2,747

13,352

85,325

8

5,756,121

100.0

Rats

Yes

6,662

4,395

3,777

535

0

0

2,499

0

17,868

1.5

No

317,369

230,944

554,792

2,160

2,384

0

38,650

0

1,146,299

98.5

Total

324,031

235,339

558,569

2,695

2,384

0

41,149

0

1,164,167

100.0

Guinea-Pigs

Yes

25

142

586

55

0

0

405

0

1,213

0.8

No

22,150

7,393

112,646

938

10

0

1,687

0

144,824

99.2

Total

22,175

7,535

113,232

993

10

0

2,092

0

146,037

100.0

Hamsters (Syrian)

Yes

8

0

0

0

0

0

15

0

23

0.2

No

1,482

4,011

6,810

100

0

0

297

0

12,700

99.8

Total

1,490

4,011

6,810

100

0

0

312

0

12,723

100.0

Hamsters (Chinese)

Yes

0

0

0

0

0

0

0

0

0

0.0

No

3

120

59

0

0

0

5

0

187

100.0

Total

3

120

59

0

0

0

5

0

187

100.0

Mongolian gerbil

Yes

45

101

0

0

0

0

0

0

146

2.7

No

1,449

2,082

1,480

109

0

10

109

0

5,239

97.3

Total

1,494

2,183

1,480

109

0

10

109

0

5,385

100.0

Other rodents

Yes

254

0

0

0

0

0

26

0

280

1.1

No

14,979

464

9,224

0

169

77

259

0

25,172

98.9

Total

15,233

464

9,224

0

169

77

285

0

25,452

100.0

Rabbits

Yes

159

524

10,286

992

0

0

509

0

12,470

3.4

No

23,355

11,337

84,029

231,447

331

0

1,462

0

351,961

96.6

Total

23,514

11,861

94,315

232,439

331

0

1,971

0

364,431

100.0

Cats

Yes

511

211

719

0

0

0

18

0

1,459

43.7

No

239

922

653

10

0

0

55

0

1,879

56.3

Total

750

1,133

1,372

10

0

0

73

0

3,338

100.0

Dogs

Yes

1,111

2,774

3,144

274

0

0

368

0

7,671

35.9

No

512

5,420

7,493

56

15

0

192

0

13,688

64.1

Total

1,623

8,194

10,637

330

15

0

560

0

21,359

100.0

Ferrets

Yes

5

35

0

0

0

0

56

0

96

4.5

No

314

1,147

476

63

0

0

16

0

2,016

95.5

Total

319

1,182

476

63

0

0

72

0

2,112

100.0

Other carnivores

Yes

101

12

0

0

12

3

0

0

128

5.1

No

775

606

756

20

111

118

0

0

2,386

94.9

Total

876

618

756

20

123

121

0

0

2,514

100.0

Horses, donkeys and cross-breeds

Yes

1,305

174

63

9,494

4

0

170

0

11,210

82.3

No

449

1,396

257

124

2

0

186

0

2,414

17.7

Total

1,754

1,570

320

9,618

6

0

356

0

13,624

100.0

Pigs

Yes

1,415

785

1,270

0

0

0

883

0

4,353

5.7

No

16,907

31,930

11,427

460

608

2

10,152

36

71,522

94.3

Total

18,322

32,715

12,697

460

608

2

11,035

36

75,875

100.0

Goats

Yes

546

12

24

19

0

0

104

0

705

31.1

No

598

716

97

27

0

0

125

0

1,563

68.9

Total

1,144

728

121

46

0

0

229

0

2,268

100.0

Sheep

Yes

3,041

819

327

42,309

2

0

217

0

46,715

71.3

No

5,516

7,435

1,035

3,356

117

0

1,265

88

18,812

28.7

Total

8,557

8,254

1,362

45,665

119

0

1,482

88

65,527

100.0

Cattle

Yes

1,665

1,391

550

215

151

0

2,661

0

6,633

17.8

No

13,132

8,996

3,207

386

2,302

0

2,594

26

30,643

82.2

Total

14,797

10,387

3,757

601

2,453

0

5,255

26

37,276

100.0

Prosimians

Yes

75

0

0

0

0

0

0

0

75

43.4

No

98

0

0

0

0

0

0

0

98

56.6

Total

173

0

0

0

0

0

0

0

173

100.0

Marmoset and tamarins

Yes

32

51

12

86

0

0

0

0

181

28.0

No

150

111

203

0

0

0

1

0

465

72.0

Total

182

162

215

86

0

0

1

0

646

100.0

Squirrel monkey

Yes

0

0

0

0

0

0

0

0

0

0.0

No

7

1

0

0

0

0

0

0

8

100.0

Total

7

1

0

0

0

0

0

0

8

100.0

Other species of new world monkeys (Ceboidea)

Yes

0

0

0

0

0

0

0

0

0

0.0

No

3

0

0

0

0

0

0

0

3

100.0

Total

3

0

0

0

0

0

0

0

3

100.0

Cynomolgus monkey

Yes

130

523

1,100

1,017

0

0

10

0

2,780

27.8

No

399

602

6,183

36

0

0

7

0

7,227

72.2

Total

529

1,125

7,283

1,053

0

0

17

0

10,007

100.0

Rhesus monkey

Yes

143

103

0

29

0

0

0

0

275

43.8

No

107

231

11

0

0

0

4

0

353

56.2

Total

250

334

11

29

0

0

4

0

628

100.0

Vervets (Chlorocebus spp.)

Yes

0

15

0

5

0

0

0

0

20

37.7

No

22

11

0

0

0

0

0

0

33

62.3

Total

22

26

0

5

0

0

0

0

53

100.0

Baboons

Yes

10

11

0

0

0

0

0

0

21

45.7

No

0

25

0

0

0

0

0

0

25

54.3

Total

10

36

0

0

0

0

0

0

46

100.0

Other species of old world monkeys (Cercopithecoidea)

Yes

0

12

0

0

0

0

0

0

12

34.3

No

14

9

0

0

0

0

0

0

23

65.7

Total

14

21

0

0

0

0

0

0

35

100.0

Other mammals

Yes

605

124

0

0

0

0

2

0

731

2.7

No

4,431

21,416

0

1

94

274

119

0

26,335

97.3

Total

5,036

21,540

0

1

94

274

121

0

27,066

100.0

Domestic fowl

Yes

488

4,694

1,339

153

240

0

545

0

7,459

1.6

No

107,897

102,329

145,149

102,252

2,519

343

3,749

315

464,553

98.4

Total

108,385

107,023

146,488

102,405

2,759

343

4,294

315

472,012

100.0

Other birds

Yes

2,182

139

0

21

278

1

315

0

2,936

2.9

No

55,174

12,953

5,004

22,800

2,289

695

495

0

99,410

97.1

Total

57,356

13,092

5,004

22,821

2,567

696

810

0

102,346

100.0

Reptiles

Yes

3,601

0

0

0

0

0

24

0

3,625

55.2

No

2,666

117

0

0

8

70

76

0

2,937

44.8

Total

6,267

117

0

0

8

70

100

0

6,562

100.0

Rana

Yes

4

0

0

0

0

0

9

0

13

0.4

No

794

108

91

0

200

0

2,292

0

3,485

99.6

Total

798

108

91

0

200

0

2,301

0

3,498

100.0

Xenopus

Yes

6,750

873

0

210

0

0

71

0

7,904

36.9

No

8,880

2,773

653

0

902

0

331

0

13,539

63.1

Total

15,630

3,646

653

210

902

0

402

0

21,443

100.0

Other amphibians

Yes

72

11

0

0

180

0

0

0

263

2.4

No

7,350

1,040

59

0

1,631

398

205

0

10,683

97.6

Total

7,422

1,051

59

0

1,811

398

205

0

10,946

100.0

Zebra fish

Yes

4,396

18

0

0

0

0

6

0

4,420

0.9

No

349,940

100,219

45,373

0

2,416

140

1,675

0

499,763

99.1

Total

354,336

100,237

45,373

0

2,416

140

1,681

0

504,183

100.0

Other fish

Yes

2,177

514

122

0

392

0

39

0

3,244

0.4

No

328,584

93,208

126,568

49

104,640

63,410

3,473

0

719,932

99.6

Total

330,761

93,722

126,690

49

105,032

63,410

3,512

0

723,176

100.0

Cephalopods

Yes

0

0

0

0

0

0

0

0

0

0.0

No

22

455

0

0

33

0

4

0

514

100.0

Total

22

455

0

0

33

0

4

0

514

100.0

All Species

Yes

58,499

29,798

34,863

55,826

1,259

11

13,323

0

193,579

2.0

No

4,299,154

2,170,158

2,151,996

413,532

123,528

78,882

150,439

473

9,388,162

98.0

Total

4,357,653

2,199,956

2,186,859

469,358

124,787

78,893

163,762

473

9,581,741

100.0

Table 14: Genetic status of animals used by species and main categories of scientific purposes (2017)

Genetic status

Basic research

Translational and applied research

Regulatory use

Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Total

%

Mice

Not altered

1,399,831

1,038,855

994,986

49,235

2,747

540

73,126

0

3,559,320

61.8

Non harmful

1,366,539

369,566

43,196

315

0

12,434

11,539

0

1,803,589

31.3

Harmful

267,998

122,545

1,623

0

0

378

660

8

393,212

6.8

Total

3,034,368

1,530,966

1,039,805

49,550

2,747

13,352

85,325

8

5,756,121

100.0

Rats

Not altered

303,734

226,481

556,201

2,572

2,384

0

40,396

0

1,131,768

97.2

Non harmful

15,959

4,910

2,270

123

0

0

712

0

23,974

2.1

Harmful

4,338

3,948

98

0

0

0

41

0

8,425

0.7

Total

324,031

235,339

558,569

2,695

2,384

0

41,149

0

1,164,167

100.0

Guinea-Pigs

Not altered

22,175

7,535

113,232

993

10

0

2,092

0

146,037

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

22,175

7,535

113,232

993

10

0

2,092

0

146,037

100.0

Hamsters (Syrian)

Not altered

1,490

3,824

6,810

100

0

0

312

0

12,536

98.5

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

187

0

0

0

0

0

0

187

1.5

Total

1,490

4,011

6,810

100

0

0

312

0

12,723

100.0

Hamsters (Chinese)

Not altered

3

120

59

0

0

0

5

0

187

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

3

120

59

0

0

0

5

0

187

100.0

Mongolian gerbil

Not altered

1,494

2,183

1,480

109

0

10

109

0

5,385

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,494

2,183

1,480

109

0

10

109

0

5,385

100.0

Other rodents

Not altered

15,233

464

9,224

0

169

77

285

0

25,452

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

15,233

464

9,224

0

169

77

285

0

25,452

100.0

Rabbits

Not altered

23,398

11,800

94,315

204,998

331

0

1,959

0

336,801

92.4

Non harmful

88

61

0

27,441

0

0

12

0

27,602

7.6

Harmful

28

0

0

0

0

0

0

0

28

0.0

Total

23,514

11,861

94,315

232,439

331

0

1,971

0

364,431

100.0

Cats

Not altered

750

1,133

1,372

10

0

0

73

0

3,338

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

750

1,133

1,372

10

0

0

73

0

3,338

100.0

Dogs

Not altered

1,519

8,166

10,637

330

15

0

560

0

21,227

99.4

Non harmful

0

12

0

0

0

0

0

0

12

0.1

Harmful

104

16

0

0

0

0

0

0

120

0.6

Total

1,623

8,194

10,637

330

15

0

560

0

21,359

100.0

Ferrets

Not altered

319

1,182

476

63

0

0

72

0

2,112

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

319

1,182

476

63

0

0

72

0

2,112

100.0

Other carnivores

Not altered

876

618

756

20

123

121

0

0

2,514

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

876

618

756

20

123

121

0

0

2,514

100.0

Horses, donkeys and cross-breeds

Not altered

1,754

1,570

320

9,618

6

0

356

0

13,624

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,754

1,570

320

9,618

6

0

356

0

13,624

100.0

Pigs

Not altered

18,182

32,394

12,697

460

608

2

10,995

36

75,374

99.3

Non harmful

121

172

0

0

0

0

40

0

333

0.4

Harmful

19

149

0

0

0

0

0

0

168

0.2

Total

18,322

32,715

12,697

460

608

2

11,035

36

75,875

100.0

Goats

Not altered

1,144

728

121

46

0

0

229

0

2,268

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

1,144

728

121

46

0

0

229

0

2,268

100.0

Sheep

Not altered

8,552

8,254

1,362

45,665

119

0

1,482

88

65,522

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

5

0

0

0

0

0

0

0

5

0.0

Total

8,557

8,254

1,362

45,665

119

0

1,482

88

65,527

100.0

Cattle

Not altered

14,797

10,387

3,757

601

2,453

0

5,255

26

37,276

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

14,797

10,387

3,757

601

2,453

0

5,255

26

37,276

100.0

Prosimians

Not altered

173

0

0

0

0

0

0

0

173

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

173

0

0

0

0

0

0

0

173

100.0

Marmoset and tamarins

Not altered

182

162

215

86

0

0

1

0

646

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

182

162

215

86

0

0

1

0

646

100.0

Squirrel monkey

Not altered

7

1

0

0

0

0

0

0

8

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

7

1

0

0

0

0

0

0

8

100.0

Other species of new world monkeys (Ceboidea)

Not altered

3

0

0

0

0

0

0

0

3

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

3

0

0

0

0

0

0

0

3

100.0

Cynomolgus monkey

Not altered

529

1,125

7,283

1,053

0

0

17

0

10,007

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

529

1,125

7,283

1,053

0

0

17

0

10,007

100.0

Rhesus monkey

Not altered

250

334

11

29

0

0

4

0

628

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

250

334

11

29

0

0

4

0

628

100.0

Vervets (Chlorocebus spp.)

Not altered

22

26

0

5

0

0

0

0

53

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

22

26

0

5

0

0

0

0

53

100.0

Baboons

Not altered

10

36

0

0

0

0

0

0

46

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

10

36

0

0

0

0

0

0

46

100.0

Other species of old world monkeys (Cercopithecoidea)

Not altered

14

21

0

0

0

0

0

0

35

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

14

21

0

0

0

0

0

0

35

100.0

Other mammals

Not altered

5,013

21,540

0

1

94

274

121

0

27,043

99.9

Non harmful

23

0

0

0

0

0

0

0

23

0.1

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

5,036

21,540

0

1

94

274

121

0

27,066

100.0

Domestic fowl

Not altered

107,748

107,023

146,488

102,405

2,759

343

4,294

315

471,375

99.9

Non harmful

637

0

0

0

0

0

0

0

637

0.1

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

108,385

107,023

146,488

102,405

2,759

343

4,294

315

472,012

100.0

Other birds

Not altered

57,356

13,092

5,004

22,821

2,567

696

810

0

102,346

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

57,356

13,092

5,004

22,821

2,567

696

810

0

102,346

100.0

Reptiles

Not altered

6,267

117

0

0

8

70

100

0

6,562

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

6,267

117

0

0

8

70

100

0

6,562

100.0

Rana

Not altered

798

108

91

0

200

0

2,301

0

3,498

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

798

108

91

0

200

0

2,301

0

3,498

100.0

Xenopus

Not altered

13,688

3,454

653

210

902

0

390

0

19,297

90.0

Non harmful

1,583

192

0

0

0

0

12

0

1,787

8.3

Harmful

359

0

0

0

0

0

0

0

359

1.7

Total

15,630

3,646

653

210

902

0

402

0

21,443

100.0

Other amphibians

Not altered

6,751

1,051

59

0

1,811

398

205

0

10,275

93.9

Non harmful

671

0

0

0

0

0

0

0

671

6.1

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

7,422

1,051

59

0

1,811

398

205

0

10,946

100.0

Zebra fish

Not altered

70,628

60,841

45,323

0

2,416

7

1,227

0

180,442

35.8

Non harmful

254,763

38,893

0

0

0

133

454

0

294,243

58.4

Harmful

28,945

503

50

0

0

0

0

0

29,498

5.9

Total

354,336

100,237

45,373

0

2,416

140

1,681

0

504,183

100.0

Other fish

Not altered

328,729

90,734

126,690

49

105,023

63,410

3,512

0

718,147

99.3

Non harmful

1,828

2,988

0

0

9

0

0

0

4,825

0.7

Harmful

204

0

0

0

0

0

0

0

204

0.0

Total

330,761

93,722

126,690

49

105,032

63,410

3,512

0

723,176

100.0

Cephalopods

Not altered

22

455

0

0

33

0

4

0

514

100.0

Non harmful

0

0

0

0

0

0

0

0

0

0.0

Harmful

0

0

0

0

0

0

0

0

0

0.0

Total

22

455

0

0

33

0

4

0

514

100.0

All Species

Harmful

302,000

127,348

1,771

0

0

378

701

8

432,206

4.5

Non harmful

1,642,212

416,794

45,466

27,879

9

12,567

12,769

0

2,157,696

22.5

Not altered

2,413,441

1,655,814

2,139,622

441,479

124,778

65,948

150,292

465

6,991,839

73.0

Total

4,357,653

2,199,956

2,186,859

469,358

124,787

78,893

163,762

473

9,581,741

100.0



Part 3: Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU



Table 15: Use of animals for the creation of new genetically altered animal lines by research type species and severity (2017)

Severity

Basic research

Translational and applied research

Total

%

Mice

Non-recovery

23,615

382

23,997

4.9

Mild

356,584

18,048

374,632

76.3

Moderate

70,843

8,809

79,652

16.2

Severe

12,014

422

12,436

2.5

Total

463,056

27,661

490,717

100.0

Rats

Non-recovery

153

0

153

1.5

Mild

6,613

523

7,136

71.6

Moderate

1,036

685

1,721

17.3

Severe

554

396

950

9.5

Total

8,356

1,604

9,960

100.0

Rabbits

Non-recovery

102

133

235

49.5

Mild

24

0

24

5.1

Moderate

109

107

216

45.5

Severe

0

0

0

0.0

Total

235

240

475

100.0

Pigs

Non-recovery

2

6

8

3.5

Mild

133

74

207

91.2

Moderate

2

0

2

0.9

Severe

10

0

10

4.4

Total

147

80

227

100.0

Sheep

Non-recovery

0

0

0

0.0

Mild

14

0

14

82.4

Moderate

3

0

3

17.6

Severe

0

0

0

0.0

Total

17

0

17

100.0

Marmoset and tamarins

Non-recovery

0

0

0

0.0

Mild

9

0

9

90.0

Moderate

1

0

1

10.0

Severe

0

0

0

0.0

Total

10

0

10

100.0

Other mammals

Non-recovery

16

0

16

26.2

Mild

34

0

34

55.7

Moderate

11

0

11

18.0

Severe

0

0

0

0.0

Total

61

0

61

100.0

Domestic fowl

Non-recovery

0

0

0

0.0

Mild

620

27

647

100.0

Moderate

0

0

0

0.0

Severe

0

0

0

0.0

Total

620

27

647

100.0

Xenopus

Non-recovery

0

0

0

0.0

Mild

250

0

250

100.0

Moderate

0

0

0

0.0

Severe

0

0

0

0.0

Total

250

0

250

100.0

Zebra fish

Non-recovery

1,018

40

1,058

0.7

Mild

127,533

4,503

132,036

87.7

Moderate

15,114

190

15,304

10.2

Severe

2,198

0

2,198

1.5

Total

145,863

4,733

150,596

100.0

Other fish

Non-recovery

0

0

0

0.0

Mild

4,562

0

4,562

99.8

Moderate

7

0

7

0.2

Severe

0

0

0

0.0

Total

4,569

0

4,569

100.0

All Species

Non-recovery

24,906

561

25,467

3.9

Mild

496,376

23,175

519,551

79.0

Moderate

87,126

9,791

96,917

14.7

Severe

14,776

818

15,594

2.4

Total

623,184

34,345

657,529

100.0



Table 16: Use of animals for the creation of new genetically altered animal lines by research type species and severity (2017)

Reuse

Basic research

Translational and applied research

Total

%

Mice

Yes

1,895

225

2,120

0.4

No

461,161

27,436

488,597

99.6

Total

463,056

27,661

490,717

100.0

Rats

Yes

0

0

0

0.0

No

8,356

1,604

9,960

100.0

Total

8,356

1,604

9,960

100.0

Rabbits

Yes

0

0

0

0.0

No

235

240

475

100.0

Total

235

240

475

100.0

Pigs

Yes

0

3

3

1.3

No

147

77

224

98.7

Total

147

80

227

100.0

Sheep

Yes

0

0

0

0.0

No

17

0

17

100.0

Total

17

0

17

100.0

Marmoset and tamarins

Yes

0

0

0

0.0

No

10

0

10

100.0

Total

10

0

10

100.0

Other mammals

Yes

0

0

0

0.0

No

61

0

61

100.0

Total

61

0

61

100.0

Domestic fowl

Yes

0

0

0

0.0

No

620

27

647

100.0

Total

620

27

647

100.0

Xenopus

Yes

0

0

0

0.0

No

250

0

250

100.0

Total

250

0

250

100.0

Zebra fish

Yes

20,621

80

20,701

13.7

No

125,242

4,653

129,895

86.3

Total

145,863

4,733

150,596

100.0

Other fish

Yes

0

0

0

0.0

No

4,569

0

4,569

100.0

Total

4,569

0

4,569

100.0

All Species

Yes

22,516

308

22,824

3.5

No

600,668

34,037

634,705

96.5

Total

623,184

34,345

657,529

100.0



Table 17: Uses of animals for the creation of new genetically altered animal lines in basic research by species and type of research (2017)

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

%

Mammals

Rodents

Mice

77,684

16,920

62,701

1,227

10,587

12,912

47,995

22,816

10,793

16,200

117,781

474

64,966

463,056

74.3

Rats

0

3,180

1,815

0

0

0

673

29

0

0

973

0

1,686

8,356

1.3

Guinea-Pigs

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

81

0

0

0

0

0

60

0

0

0

0

94

235

0

Farm animals

Pigs

0

5

4

0

0

11

79

0

0

0

39

0

9

147

0

Sheep

0

0

16

1

0

0

0

0

0

0

0

0

0

17

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

0

0

0

0

10

10

0

Other mammals

Other mammals

0

0

61

0

0

0

0

0

0

0

0

0

0

61

0

Birds

Domestic fowl

0

0

0

0

0

0

0

125

0

0

495

0

0

620

0.1

Amphibians

Xenopus

0

0

0

0

0

0

0

0

0

0

0

0

250

250

0

Fish

Zebra fish

4,109

45,549

28,686

0

109

3,728

10,786

4,140

5,787

2,549

19,260

6,917

14,243

145,863

23.4

Other fish

69

24

1

0

0

0

0

778

2,394

0

1,296

0

7

4,569

0.7

Totals

Total

81,862

65,759

93,284

1,228

10,696

16,651

59,533

27,948

18,974

18,749

139,844

7,391

81,265

623,184

100

%

13.1

10.6

15

0.2

1.7

2.7

9.6

4.5

3

3

22.4

1.2

13

100



Table 18.1: Uses of animals for the creation of new genetically altered animal lines in basic, translational and applied research by species and type of research (Part 1) (2017)

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Mammals

Rodents

Mice

9,346

490

2,074

2,866

263

2,544

305

2,265

Rats

44

0

149

971

0

0

408

0

Guinea-Pigs

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

0

0

0

0

0

0

0

Farm animals

Pigs

26

0

9

11

0

0

13

0

Sheep

0

0

0

0

0

0

0

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

Birds

Domestic fowl

0

0

0

0

0

0

0

0

Amphibians

Xenopus

0

0

0

0

0

0

0

0

Fish

Zebra fish

0

730

1,480

242

0

0

155

0

Other fish

0

0

0

0

0

0

0

0

Totals

Total

9,416

1,220

3,712

4,090

263

2,544

881

2,265

%

27.8

3.6

11

12.1

0.8

7.5

2.6

6.7



Table 18.2: Uses of animals for the creation of new genetically altered animal lines in basic translational and applied research by species and type of research (Part 2) (2017)

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Non-regulatory toxicology and ecotoxicology

Total

%

Mammals

Rodents

Mice

654

67

4,469

502

1,816

0

0

0

27,661

80.5

Rats

0

15

0

0

0

17

0

0

1,604

4.7

Guinea-Pigs

0

0

0

0

0

0

0

0

0

0

Other rodents

0

0

0

0

0

0

0

0

0

0

Rabbits

Rabbits

0

0

232

0

8

0

0

0

240

0.7

Farm animals

Pigs

0

12

5

4

0

0

0

0

80

0.2

Sheep

0

0

0

0

0

0

0

0

0

0

Non-human primates

Marmoset and tamarins

0

0

0

0

0

0

0

0

0

0

Other mammals

Other mammals

0

0

0

0

0

0

0

0

0

0

Birds

Domestic fowl

0

0

0

0

27

0

0

0

27

0.1

Amphibians

Xenopus

0

0

0

0

0

0

0

0

0

0

Fish

Zebra fish

0

1,074

0

40

0

0

502

510

4,733

13.8

Other fish

0

0

0

0

0

0

0

0

0

0

Totals

Total

654

1,168

4,706

546

1,851

17

502

510

34,345

100

%

1.9

3.4

13.7

1.6

5.4

0

1.5

1.5

100



Table 19: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, severity and genetic status (2017)

Severity

Genetically altered with a harmful phenotype

Genetically altered without a harmful phenotype

Not genetically altered

Total

%

Mice

Non-recovery

417

225

71

713

0.1

Mild

48,209

359,141

30,784

438,134

77.7

Moderate

37,965

37,786

3,358

79,109

14.0

Severe

22,525

23,197

106

45,828

8.1

Total

109,116

420,349

34,319

563,784

100.0

Rats

Non-recovery

0

0

0

0

0.0

Mild

2,271

816

590

3,677

54.1

Moderate

830

755

391

1,976

29.1

Severe

1,132

14

0

1,146

16.9

Total

4,233

1,585

981

6,799

100.0

Dogs

Non-recovery

0

0

0

0

0.0

Mild

0

0

0

0

0.0

Moderate

0

0

0

0

0.0

Severe

0

10

0

10

100.0

Total

0

10

0

10

100.0

Domestic fowl

Non-recovery

0

0

0

0

0.0

Mild

0

242

26

268

73.0

Moderate

93

0

0

93

25.3

Severe

6

0

0

6

1.6

Total

99

242

26

367

100.0

Xenopus

Non-recovery

0

0

0

0

0.0

Mild

0

376

14

390

99.5

Moderate

0

0

0

0

0.0

Severe

0

1

1

2

0.5

Total

0

377

15

392

100.0

Zebra fish

Non-recovery

0

1

26

27

0.0

Mild

15,297

48,754

3,830

67,881

95.8

Moderate

128

2,034

2

2,164

3.1

Severe

127

637

4

768

1.1

Total

15,552

51,426

3,862

70,840

100.0

Other fish

Non-recovery

0

0

0

0

0.0

Mild

2

114

0

116

18.1

Moderate

0

524

0

524

81.9

Severe

0

0

0

0

0.0

Total

2

638

0

640

100.0

All Species

Non-recovery

417

226

97

740

0.1

Mild

65,779

409,443

35,244

510,466

79.4

Moderate

39,016

41,099

3,751

83,866

13.0

Severe

23,790

23,859

111

47,760

7.4

Total

129,002

474,627

39,203

642,832

100.0



Table 20: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, reuse and genetic status (2017)

Reuse

Not genetically altered

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

%

Mice

Yes

0

72

69

141

0.0

No

34,319

420,277

109,047

563,643

100.0

Total

34,319

420,349

109,116

563,784

100.0

Rats

Yes

0

0

0

0

0.0

No

981

1,585

4,233

6,799

100.0

Total

981

1,585

4,233

6,799

100.0

Dogs

Yes

0

0

0

0

0.0

No

0

10

0

10

100.0

Total

0

10

0

10

100.0

Domestic fowl

Yes

0

0

0

0

0.0

No

26

242

99

367

100.0

Total

26

242

99

367

100.0

Xenopus

Yes

4

193

0

197

50.3

No

11

184

0

195

49.7

Total

15

377

0

392

100.0

Zebra fish

Yes

149

463

0

612

0.9

No

3,713

50,963

15,552

70,228

99.1

Total

3,862

51,426

15,552

70,840

100.0

Other fish

Yes

0

0

0

0

0.0

No

0

638

2

640

100.0

Total

0

638

2

640

100.0

All Species

Yes

153

728

69

950

0.1

No

39,050

473,899

128,933

641,882

99.9

Total

39,203

474,627

129,002

642,832

100.0

Top

Brussels, 5.2.2020

SWD(2020) 10 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017













{COM(2020) 16 final}


SECTION C: MEMBER STATE DATA BETWEEN 2015 AND 2017

V. Member State narratives and data submissions 2015-2017

V.1. Introduction    

V.2. Member State narratives and data submissions 2015-2017    

Austria    

Austria: Narrative 2015    

Austria: Statistical Data 2015    

Austria: Narrative 2016    

Austria: Statistical Data 2016    

Austria: Narrative 2017    

Austria: Statistical Data 2017    

Belgium    

Belgium: Narrative 2015    

Belgium: Statistical Data 2015    

Belgium: Narrative 2016    

Belgium: Statistical Data 2016    

Belgium: Narrative 2017    

Belgium: Statistical Data 2017    

Bulgaria    

Bulgaria: Narrative 2015 - no narrative submitted    

Bulgaria : Statistical Data 2015    

Bulgaria: Narrative 2016 - no narrative submitted    

Bulgaria: Statistical Data 2016    

Bulgaria: Narrative 2017 - no narrative submitted    

Bulgaria: Statistical Data 2017    

Croatia    

Croatia: Narrative 2015    

Croatia: Statistical Data 2015    

Croatia: Narrative 2016    

Croatia: Statistical Data 2016    

Croatia: Narrative 2017    

Croatia: Statistical Data 2017    

Cyprus    

Cyprus: Narrative 2015    

Cyprus: Statistical Data 2015    

Cyprus: Narrative 2016    

Cyprus: Statistical Data 2016    

Cyprus: Narrative 2017    

Cyprus: Statistical Data 2017    

Czechia    

Czechia: Narrative 2015    

Czechia: Statistical Data 2015    

Czechia: Narrative 2016    

Czechia: Statistical Data 2016    

Czechia: Narrative 2017    

Czechia: Statistical Data 2017    

Denmark    

Denmark: Narrative 2015    

Denmark: Statistical Data 2015    

Denmark: Narrative 2016    

Denmark: Statistical Data 2016    

Denmark: Narrative 2017    

Denmark: Statistical Data 2017    

Estonia    

Estonia: Narrative 2015    

Estonia: Statistical Data 2015    

Estonia: Narrative 2016    

Estonia: Statistical Data 2016    

Estonia: Narrative 2017    

Estonia: Statistical Data 2017    

Finland    

Finland: Narrative 2015    

Finland: Statistical Data 2015    

Finland: Narrative 2016    

Finland: Statistical Data 2016    

Finland: Narrative 2017    

Finland: Statistical Data 2017    

France    

France: Narrative 2015    

France: Statistical Data 2015    

France: Narrative 2016    

France: Statistical Data 2016    

France: Narrative 2017    

France: Statistical Data 2017    

Germany    

Germany: Narrative 2015    

Germany: Statistical Data 2015    

Germany: Narrative 2016    

Germany: Statistical Data 2016    

Germany: Narrative 2017    

Germany: Statistical Data 2017    

Greece    

Greece: Narrative 2015    

Greece: Statistical Data 2015    

Greece: Narrative 2016    

Greece: Statistical Data 2016    

Greece: Narrative 2017    

Greece: Statistical Data 2017    

Hungary    

Hungary: Narrative 2015    

Hungary: Statistical Data 2015    

Hungary: Narrative 2016    

Hungary: Statistical Data 2016    

Hungary: Narrative 2017    

Hungary: Statistical Data 2017    

Ireland    

Ireland: Narrative 2015    

Ireland: Statistical Data 2015    

Ireland: Narrative 2016    

Ireland: Statistical Data 2016    

Ireland: Narrative 2017    

Ireland: Statistical Data 2017    

Italy    

Italy: Narrative 2015    

Italy: Statistical Data 2015    

Italy: Narrative 2016    

Italy: Statistical Data 2016    

Italy: Narrative 2017    

Italy: Statistical Data 2017    

Latvia    

Latvia: Narrative 2015    

Latvia: Statistical Data 2015    

Latvia: Narrative 2016    

Latvia: Statistical Data 2016    

Latvia: Narrative 2017    

Latvia: Statistical Data 2017    

Lithuania    

Lithuania: Narrative 2015    

Lithuania: Statistical Data 2016    

Lithuania: Narrative 2016    

Lithuania: Statistical Data 2016    

Lithuania: Narrative 2017    

Lithuania: Statistical Data 2017    

Luxembourg    

Luxembourg: Narrative 2015    

Luxembourg: Statistical Data 2015    

Luxembourg: Narrative 2016    

Luxembourg: Statistical Data 2016    

Luxembourg: Narrative 2017    

Luxembourg: Statistical Data 2017    

Malta    

Malta: Narrative 2015    

Malta: Statistical Data 2015    

Malta: Narrative 2016    

Malta: Statistical Data 2016    

Malta: Narrative 2017    

Malta: Statistical Data 2017    

Netherlands    

Netherlands: Narrative 2015    

Netherlands: Statistical Data 2015    

Netherlands: Narrative 2016    

Netherlands: Statistical Data 2016    

Netherlands: Narrative 2017    

Netherlands: Statistical Data 2017    

Poland    

Poland: Narrative 2015    

Poland: Statistical Data 2015    

Poland: Narrative 2016    

Poland: Statistical Data 2016    

Poland: Narrative 2017    

Poland: Statistical Data 2017    

Portugal    

Portugal: Narrative 2015 – no narrative submitted    

Portugal: Statistical Data 2015    

Portugal: Narrative 2016 - no narrative submitted    

Portugal: Statistical Data 2016    

Portugal: Narrative 2017 - no narrative submitted    

Portugal: Statistical Data 2017    

Romania    

Romania: Narrative 2015    

Romania: Statistical Data 2015    

Romania: Narrative 2016    

Romania: Statistical Data 2016    

Romania: Narrative 2017    

Romania: Statistical Data 2017    

Slovakia    

Slovakia: Narrative 2015    

Slovakia: Statistical Data 2015    

Slovakia: Narrative 2016    

Slovakia: Statistical Data 2016    

Slovakia: Narrative 2017    

Slovakia: Statistical Data 2017    

Slovenia    

Slovenia: Narrative 2015    

Slovenia: Statistical Data 2015    

Slovenia: Narrative 2016    

Slovenia: Statistical Data 2016    

Slovenia: Narrative 2017    

Slovenia: Statistical Data 2017    

Spain    

Spain: Narrative 2015    

Spain: Statistical Data 2015    

Spain: Narrative 2016    

Spain: Statistical Data 2016    

Spain: Narrative 2017    

Spain: Statistical Data 2017    

Sweden    

Sweden: Narrative 2015    

Sweden: Statistical Data 2015    

Sweden: Narrative 2016    

Sweden: Statistical Data 2016    

Sweden: Narrative 2017    

Sweden: Statistical Data 2017    

United Kingdom    

United Kingdom: Narrative 2015    

United Kingdom: Statistical Data 2015    

United Kingdom: Narrative 2016    

United Kingdom: Statistical Data 2016    

United Kingdom: Narrative 2017    

United Kingdom: Statistical Data 2017    



V.1. Introduction

Member States submitted statistical data to the Commission between 2015 and 2017 using the main categorisation of data attributes provided in the Annex II of Commission Implementing Decision 2012/707/EU. The accompanying Member State narratives make reference to the numbers in these submissions.

However, the numbers contained in the Member State submission do not directly correlate with the compiled EU data.

Drawing from the Member State submissions, the EU report is based on a revised, improved, categorisation of data:

·Numbers of animals used for purposes of research, testing, routine production and education (including training) – Part 1 (III.1)

·Details of all uses (first and any subsequent reuse) of animals for the purposes of research, testing, routine production and education (including training) - Part 2 (III.2)

·Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU – Part 3 (III.3)

This has allowed for the presentation of a much clearer and precise picture of the numbers of animals and purposes for which animals are used in the EU.

To provide a possibility to refer back to the Member State data in a similar manner, the part V.3. of this Section C presents recalculation of the Member State data, for the year 2017, divided into the three categories above.

V.2. Member State narratives and data submissions 2015-2017

Member States annual submissions between years 2015 and 2017 are listed by Member State, first providing the Member State narrative for the respective year followed by the related data tables.

As stated above, these numbers do not directly correlate with numbers in the EU report in Part A but have been left here so that accurate presentation of the Member State submissions is provided, including correspondence with the related annual narratives.



Austria

Austria: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

Austria already collected statistical data on animals used in 2013 in the new format. Due to changes in the regime for counting the animals (e.g. counting animals at the beginning of a procedure vs. counting them at the end) comparisons with the years before 2013 can only be made with caution. The overall number of animals used in 2015 was 227.317 (2014: 209.183), this constitutes an increase of 8,7%, in comparison to 2013 this is an increase of 9%.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Significant increases in animal use were reported for translational research on infectious diseases and regulatory pyrogenicity testing. Significant decrease in animal use was observed for translational research in oncology and regulatory batch potency testing.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The percentages of actual severities were

Non-recovery:  4% (2014:   3%)

Mild:        60% (2014: 57%)

Moderate:    24% (2014: 30%)

Severe:    12% (2014: 10%)

These changes could not be considered as significant.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The competent authorities promote the 3R principle at all the steps of the authorization processes, so that even with an increase in research activities the overall numbers of animals used have remained fairly constant.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Only small, not significant proportions were reported under the category “other”.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No such cases were observed or reported.

Austria: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

187413

82.45%

Rats

5162

2.27%

Guinea-Pigs

1858

0.82%

Hamsters (Syrian)

602

0.26%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

99

0.04%

Rabbits

15910

7%

Cats

34

0.01%

Dogs

111

0.05%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

94

0.04%

Pigs

1762

0.78%

Goats

7

0%

Sheep

115

0.05%

Cattle

632

0.28%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

515

0.23%

Domestic fowl

1623

0.71%

Other birds

465

0.2%

Reptiles

Rana

Xenopus

121

0.05%

Other Amphibians

616

0.27%

Zebra fish

9411

4.14%

Other Fish

767

0.34%

Cephalopods

Total

227317

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

216341

96.04%

Animals born in the EU but not at a registered breeder

4188

1.86%

Animals born in rest of Europe

61

0.03%

Animals born in rest of world

4678

2.08%

Total

225268

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

89479

39.36%

Translational and applied research

74146

32.62%

Regulatory use and Routine production

31789

13.98%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

551

0.24%

Preservation of species

67

0.03%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1925

0.85%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

29360

12.92%

Total

227317

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

15691

17.54%

Cardiovascular Blood and Lymphatic System

10313

11.53%

Nervous System

12922

14.44%

Respiratory System

739

0.83%

Gastrointestinal System including Liver

2525

2.82%

Musculoskeletal System

1816

2.03%

Immune System

19514

21.81%

Urogenital/Reproductive System

553

0.62%

Sensory Organs (skin, eyes and ears)

420

0.47%

Endocrine System/Metabolism

2055

2.3%

Multisystemic

8104

9.06%

Ethology / Animal Behaviour /Animal Biology

1343

1.5%

Other basic research

13484

15.07%

Total

89479

100.00%


Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

13389

18.06%

Human Infectious Disorders

42653

57.53%

Human Cardiovascular Disorders

7030

9.48%

Human Nervous and Mental Disorders

3885

5.24%

Human Respiratory Disorders

91

0.12%

Human Gastrointestinal Disorders including Liver

471

0.64%

Human Musculoskeletal Disorders

595

0.8%

Human Immune Disorders

2396

3.23%

Human Urogenital/Reproductive Disorders

167

0.23%

Human Sensory Organ Disorders (skin, eyes and ears)

262

0.35%

Human Endocrine/Metabolism Disorders

263

0.35%

Other Human Disorders

20

0.03%

Animal Diseases and Disorders

2874

3.88%

Animal Welfare

Diagnosis of diseases

15

0.02%

Plant diseases

Non-regulatory toxicology and ecotoxicology

35

0.05%

Total

74146

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

31413

98.82%

Other efficacy and tolerance testing

44

0.14%

Toxicity and other safety testing including pharmacology

151

0.48%

Routine production

181

0.57%

Total

31789

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

4708

14.99%

Pyrogenicity testing

14794

47.1%

Batch potency testing

11461

36.48%

Other quality controls

450

1.43%

Total

31413

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

6

3.97%

Neurotoxicity

88

58.28%

Kinetics

48

31.79%

Safety testing in food and feed area

9

5.96%

Total

151

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

6

100%

> 90 days

Total

6

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

181

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

181

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

31642

99.54%

Legislation on medicinal products for veterinary use and their residues

44

0.14%

Medical devices legislation

6

0.02%

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

9

0.03%

Cosmetics legislation

Other legislation

88

0.28%

Total

31789

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

27929

87.86%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

3860

12.14%

Total

31789

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

225268

99.1%

Yes

2049

0.9%

Total

227317

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

8782

3.86%

Mild [up to and including]

136602

60.09%

Moderate

54896

24.15%

Severe

27037

11.89%

Total

227317

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

215627

94.86%

Yes

11690

5.14%

Total

227317

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

135911

59.79%

Genetically altered without a harmful phenotype

73220

32.21%

Genetically altered with a harmful phenotype

18186

8%

Total

227317

100.00%



Austria: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

In Austria the total number of animals used for scientific purposes in 2016 is 236.459 (2015: 227.317), which is an increase of 4.0% or in absolute numbers 9.142 animals. Due to changes in the regime for counting the animals (e.g. counting animals at the beginning of a procedure vs. counting them at the end) comparisons with the previous years can only be made with certain caveats. However, the overall numbers between 2013 and 2016 remained within the range of the last 10 years.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

A marked increase is observed in “Basic Research, Immune System” (from 19.514 animals to 29.555 animals). On the other hand, there is a decline in “Maintenance of colonies of established genetically altered animals, not used in other procedures” (from 29.360 animals to 18.905 animals).

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The proportion of severity "severe" decreased from 12% to 7% compared to the previous year (also in absolute numbers: from 27.037 to 17.272). One possible reason for this could be the case-specific application of humane endpoints.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The competent authorities promote the 3R principle at all steps of the authorization processes, in particular by putting emphasis on minimizing pain suffering, distress and lasting harm by adequate humane endpoints. Thus, even with an increase in research activities the numbers of animals used have remained fairly constant, while at the same time the proportion of animals with “severe” suffering declined.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

“Other    rodents” include i.a. the wood mouse (not Mus musculus), the edible dormouse and garden dormouse; “Other mammals” include i.a. llamas, “Other birds” i.a. turkeys, great tits and Eurasian blackcaps; “Other fish” mainly trouts and medaka.

The purpose “Basic Research, Other” includes, in particular, the creation and maintenance of genetically altered animals (as long as their further use in projects is not yet known), as well as the production of antibodies.

6. Details on cases where the “severe” classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why “severe” classification was exceeded.

Procedures involving severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated, as referred to in Article 15(2) were not performed.

Austria: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

191896

81.15%

Rats

6344

2.68%

Guinea-Pigs

1785

0.75%

Hamsters (Syrian)

277

0.12%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

276

0.12%

Rabbits

14684

6.21%

Cats

12

0.01%

Dogs

177

0.07%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

43

0.02%

Pigs

4901

2.07%

Goats

2

0%

Sheep

423

0.18%

Cattle

386

0.16%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

150

0.06%

Domestic fowl

3307

1.4%

Other birds

1208

0.51%

Reptiles

Rana

Xenopus

148

0.06%

Other Amphibians

4

0%

Zebra fish

7960

3.37%

Other Fish

2476

1.05%

Cephalopods

Total

236459

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

224314

95.23%

Animals born in the EU but not at a registered breeder

7403

3.14%

Animals born in rest of Europe

Animals born in rest of world

3843

1.63%

Total

235560

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

103605

43.82%

Translational and applied research

74336

31.44%

Regulatory use and Routine production

36202

15.31%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

191

0.08%

Preservation of species

563

0.24%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2657

1.12%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

18905

8%

Total

236459

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

17191

16.59%

Cardiovascular Blood and Lymphatic System

11179

10.79%

Nervous System

9439

9.11%

Respiratory System

399

0.39%

Gastrointestinal System including Liver

1761

1.7%

Musculoskeletal System

2566

2.48%

Immune System

29555

28.53%

Urogenital/Reproductive System

469

0.45%

Sensory Organs (skin, eyes and ears)

1158

1.12%

Endocrine System/Metabolism

2033

1.96%

Multisystemic

10967

10.59%

Ethology / Animal Behaviour /Animal Biology

2842

2.74%

Other basic research

14046

13.56%

Total

103605

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

15369

20.68%

Human Infectious Disorders

35473

47.72%

Human Cardiovascular Disorders

7850

10.56%

Human Nervous and Mental Disorders

4748

6.39%

Human Respiratory Disorders

64

0.09%

Human Gastrointestinal Disorders including Liver

832

1.12%

Human Musculoskeletal Disorders

351

0.47%

Human Immune Disorders

1437

1.93%

Human Urogenital/Reproductive Disorders

8

0.01%

Human Sensory Organ Disorders (skin, eyes and ears)

47

0.06%

Human Endocrine/Metabolism Disorders

769

1.03%

Other Human Disorders

897

1.21%

Animal Diseases and Disorders

2637

3.55%

Animal Welfare

3848

5.18%

Diagnosis of diseases

6

0.01%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

74336

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

35884

99.12%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

72

0.2%

Routine production

246

0.68%

Total

36202

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

4228

11.78%

Pyrogenicity testing

13157

36.67%

Batch potency testing

17604

49.06%

Other quality controls

895

2.49%

Total

35884

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Neurotoxicity

22

30.56%

Target animal safety

50

69.44%

Total

72

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

246

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

246

100.00%




Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

36103

99.73%

Legislation on medicinal products for veterinary use and their residues

50

0.14%

Medical devices legislation

27

0.07%

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

22

0.06%

Total

36202

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

31134

86%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

5068

14%

Total

36202

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

235560

99.62%

Yes

899

0.38%

Total

236459

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

5815

2.46%

Mild [up to and including]

148333

62.73%

Moderate

65039

27.51%

Severe

17272

7.3%

Total

236459

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

222857

94.25%

Yes

13602

5.75%

Total

236459

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

138680

58.65%

Genetically altered without a harmful phenotype

80249

33.94%

Genetically altered with a harmful phenotype

17530

7.41%

Total

236459

100.00%



Austria: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In Austria the total number of animals used for scientific purposes in 2017 is 264.071 (2016: 236.459), which is an increase of 11.7% or in absolute numbers 27.612 animals. Due to changes in the regime for counting the animals (e.g. counting animals at the beginning of a procedure vs. counting them at the end) comparisons with the previous years can only be made with certain caveats.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The total number of fish (zebra fish and other fish) used for scientific purposes in 2017 is 20.927 (2016: 10.436). Zebra fish were mainly used for the purpose “Basic Research, Other” in particular cell and developmental biology.

With regard to the categories of purposes, a marked increase is observed in “Basic Research, Oncology” (from 17.191 animals to 25.406 animals used in 2017). For Maintenance of colonies of established genetically altered animals, not used in other procedures” a decrease was reported in 2016, whereas for 2017 an increase is observed in this category (from 18.905 animals to 29.360 animals).

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

No significant changes are observed.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The competent authorities promote the 3R principle at all steps of the authorization processes, in particular by putting emphasis on minimizing pain suffering, distress and lasting harm by adequate humane endpoints.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

“Other rodents” include i.a. the common vole and the wood mouse; “Other mammals” include i.a. the brown hare and wild boar, “Other birds” i.a. reed buntings and Eurasian blackcaps; “Other fish” include i.a. trouts.

The purpose “Basic Research, Other” includes, in particular, the creation and maintenance of genetically altered animals (as long as their further use in projects is not yet known), as well as cell and developmental biology and imaging.

6. Details on cases where the “severe” classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why “severe” classification was exceeded.

Procedures involving severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated, as referred to in Article 15(2) were not performed.

Austria: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

212913

80.63%

Rats

6038

2.29%

Guinea-Pigs

1154

0.44%

Hamsters (Syrian)

8

0%

Hamsters (Chinese)

Mongolian gerbil

41

0.02%

Other Rodents

998

0.38%

Rabbits

10388

3.93%

Cats

61

0.02%

Dogs

203

0.08%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

521

0.2%

Pigs

2040

0.77%

Goats

22

0.01%

Sheep

149

0.06%

Cattle

908

0.34%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

102

0.04%

Domestic fowl

3895

1.47%

Other birds

1819

0.69%

Reptiles

Rana

Xenopus

972

0.37%

Other Amphibians

912

0.35%

Zebra fish

16297

6.17%

Other Fish

4630

1.75%

Cephalopods

Total

264071

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

247185

93.95%

Animals born in the EU but not at a registered breeder

11909

4.53%

Animals born in rest of Europe

99

0.04%

Animals born in rest of world

3902

1.48%

Total

263095

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

127667

48.35%

Translational and applied research

77138

29.21%

Regulatory use and Routine production

26569

10.06%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

198

0.07%

Preservation of species

30

0.01%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

3108

1.18%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

29361

11.12%

Total

264071

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

25406

19.9%

Cardiovascular Blood and Lymphatic System

10272

8.05%

Nervous System

16591

13%

Respiratory System

316

0.25%

Gastrointestinal System including Liver

2229

1.75%

Musculoskeletal System

4947

3.87%

Immune System

25283

19.8%

Urogenital/Reproductive System

1128

0.88%

Sensory Organs (skin, eyes and ears)

1208

0.95%

Endocrine System/Metabolism

1694

1.33%

Multisystemic

12805

10.03%

Ethology / Animal Behaviour /Animal Biology

5799

4.54%

Other basic research

19989

15.66%

Total

127667

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

14506

18.81%

Human Infectious Disorders

42202

54.71%

Human Cardiovascular Disorders

5109

6.62%

Human Nervous and Mental Disorders

5487

7.11%

Human Respiratory Disorders

285

0.37%

Human Gastrointestinal Disorders including Liver

151

0.2%

Human Musculoskeletal Disorders

260

0.34%

Human Immune Disorders

785

1.02%

Human Urogenital/Reproductive Disorders

201

0.26%

Human Sensory Organ Disorders (skin, eyes and ears)

300

0.39%

Human Endocrine/Metabolism Disorders

1138

1.48%

Other Human Disorders

576

0.75%

Animal Diseases and Disorders

4816

6.24%

Animal Welfare

542

0.7%

Diagnosis of diseases

715

0.93%

Plant diseases

Non-regulatory toxicology and ecotoxicology

65

0.08%

Total

77138

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

25823

97.19%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

740

2.79%

Routine production

6

0.02%

Total

26569

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

2700

10.46%

Pyrogenicity testing

9125

35.34%

Batch potency testing

13554

52.49%

Other quality controls

444

1.72%

Total

25823

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Repeated dose toxicity

43

5.81%

Neurotoxicity

32

4.32%

Target animal safety

665

89.86%

Total

740

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

43

100%

> 90 days

Total

43

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

6

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

6

100.00%




Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

25870

97.37%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

2

0.01%

Industrial chemicals legislation

Plant protection product legislation

665

2.5%

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

32

0.12%

Total

26569

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

23037

86.71%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

3532

13.29%

Total

26569

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

263095

99.63%

Yes

976

0.37%

Total

264071

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

5153

1.95%

Mild [up to and including]

175022

66.28%

Moderate

62516

23.67%

Severe

21380

8.1%

Total

264071

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

241513

91.46%

Yes

22558

8.54%

Total

264071

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

145931

55.26%

Genetically altered without a harmful phenotype

82509

31.25%

Genetically altered with a harmful phenotype

35631

13.49%

Total

264071

100.00%



Belgium

Belgium: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

Compared to 2014 (660.261 animals used), there is a decrease of 14,95 % in the number of animals used for scientific purposes in 2015 (561.551 animals used).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The use of animals in the specific areas is similar to the figures of 2014.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2015 more animals were reported in the ‘severe’ category [2014: severe (14.82%), moderate (28.23%), mild (53.02%) and non-recovery (3.93%); 2015: severe (16.68%), moderate (22.14%), mild (56.69%) and non-recovery (4.49%)]. This trend is mostly due to a better reporting of the actual severities by the users and stricter controls by the ethical committees and the government.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

·Funding of research projects for the development of alternative toxicity tests

·Collaboration with the university board to promote the development and promotion of alternative methods.

·Collaboration between the different regions and other member states to promote the 3R principle.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

40.67% of the fishes are reported under the “other” category. They are mostly Clarias gariepinus and Dicentrarchus labrax. 36.67% of the amphibians reported under the “other” category are Salamandridae (in order of importance: Lissotriton helveticus, Ichthyosaura alpestris, Salamandra salamandra) and Ranidae (in order of importance: Lithobates catesbeianus, Litoria caerulea, Alytes obstetricans). 18.10% of the birds are reported under the “other” category. They are mostly Paridae, Fringillidae, Passeridae, Coturnix, Meleagrididae, Estrildida and Laridae.

19.73% of the regulatory routine production – toxicity and safety testing is reported as “other” toxicity and safety testing. This concerns mostly immunogenicity and psychopharmacology tests.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

There were no exceeding of the ‘severe’ classification reported in 2015.

Belgium: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

331692

59.07%

Rats

33686

6%

Guinea-Pigs

17363

3.09%

Hamsters (Syrian)

2246

0.4%

Hamsters (Chinese)

Mongolian gerbil

111

0.02%

Other Rodents

200

0.04%

Rabbits

43304

7.71%

Cats

82

0.01%

Dogs

1850

0.33%

Ferrets

5

0%

Other carnivores

Horses, donkeys and cross-breeds

115

0.02%

Pigs

3391

0.6%

Goats

96

0.02%

Sheep

417

0.07%

Cattle

598

0.11%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

5

0%

Rhesus monkey

41

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

131

0.02%

Domestic fowl

18350

3.27%

Other birds

4055

0.72%

Reptiles

133

0.02%

Rana

Xenopus

855

0.15%

Other Amphibians

495

0.09%

Zebra fish

60711

10.81%

Other Fish

41619

7.41%

Cephalopods

Total

561551

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

496746

91.89%

Animals born in the EU but not at a registered breeder

36621

6.77%

Animals born in rest of Europe

2693

0.5%

Animals born in rest of world

4501

0.83%

Total

540561

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

5

50%

Animals born in rest of Europe

Animals born in Asia

5

50%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

10

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

10

100%

Self-sustaining colony

Total

10

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

309245

55.07%

Translational and applied research

94736

16.87%

Regulatory use and Routine production

146804

26.14%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

377

0.07%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

8426

1.5%

Forensic enquiries

36

0.01%

Maintenance of colonies of established genetically altered animals, not used in other procedures

1927

0.34%

Total

561551

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

42541

13.76%

Cardiovascular Blood and Lymphatic System

19624

6.35%

Nervous System

48985

15.84%

Respiratory System

7410

2.4%

Gastrointestinal System including Liver

15356

4.97%

Musculoskeletal System

18962

6.13%

Immune System

59121

19.12%

Urogenital/Reproductive System

20248

6.55%

Sensory Organs (skin, eyes and ears)

4820

1.56%

Endocrine System/Metabolism

30242

9.78%

Multisystemic

15254

4.93%

Ethology / Animal Behaviour /Animal Biology

17519

5.67%

Other basic research

9163

2.96%

Total

309245

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

16760

17.69%

Human Infectious Disorders

21894

23.11%

Human Cardiovascular Disorders

1085

1.15%

Human Nervous and Mental Disorders

17936

18.93%

Human Respiratory Disorders

4176

4.41%

Human Gastrointestinal Disorders including Liver

971

1.02%

Human Musculoskeletal Disorders

181

0.19%

Human Immune Disorders

2558

2.7%

Human Urogenital/Reproductive Disorders

433

0.46%

Human Sensory Organ Disorders (skin, eyes and ears)

2880

3.04%

Human Endocrine/Metabolism Disorders

1359

1.43%

Other Human Disorders

62

0.07%

Animal Diseases and Disorders

6235

6.58%

Animal Welfare

165

0.17%

Diagnosis of diseases

7256

7.66%

Plant diseases

Non-regulatory toxicology and ecotoxicology

10785

11.38%

Total

94736

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

89897

61.24%

Other efficacy and tolerance testing

7066

4.81%

Toxicity and other safety testing including pharmacology

9705

6.61%

Routine production

40136

27.34%

Total

146804

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

13136

14.61%

Pyrogenicity testing

Batch potency testing

74356

82.71%

Other quality controls

2405

2.68%

Total

89897

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

990

10.2%

Skin irritation/corrosion

158

1.63%

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Phototoxicity

Skin sensitisation

Repeated dose toxicity

1380

14.22%

Genotoxicity

126

1.3%

Reproductive toxicity

349

3.6%

Neurotoxicity

183

1.89%

Kinetics

671

6.91%

Pharmaco-dynamics (incl safety pharmacology)

1548

15.95%

Ecotoxicity

871

8.97%

Safety testing in food and feed area

1506

15.52%

Target animal safety

8

0.08%

Other toxicity/safety testing

1915

19.73%

Total

9705

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

990

100%

Total

990

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

1380

100%

29 - 90 days

> 90 days

Total

1380

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

871

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

871

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

39961

99.56%

Monoclonal antibody by mouse ascites method

Other product types

175

0.44%

Total

40136

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

120283

81.93%

Legislation on medicinal products for veterinary use and their residues

18724

12.75%

Medical devices legislation

552

0.38%

Industrial chemicals legislation

Plant protection product legislation

136

0.09%

Biocides legislation

Food legislation including food contact material

1336

0.91%

Feed legislation including legislation for the safety of target animals, workers and environment

332

0.23%

Cosmetics legislation

Other legislation

5441

3.71%

Total

146804

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

130212

88.7%

Legislation satisfying national requirements only [within EU]

871

0.59%

Legislation satisfying Non-EU requirements only

15721

10.71%

Total

146804

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

540571

96.26%

Yes

20980

3.74%

Total

561551

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

25221

4.49%

Mild [up to and including]

318327

56.69%

Moderate

124343

22.14%

Severe

93660

16.68%

Total

561551

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

539762

96.12%

Yes

21789

3.88%

Total

561551

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

424438

75.58%

Genetically altered without a harmful phenotype

124304

22.14%

Genetically altered with a harmful phenotype

12809

2.28%

Total

561551

100.00%

Belgium: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

Compared to 2015 (561.551 animals used), there is a decrease of 4.75 % in the number of animals used for scientific purposes in 2016 (534.854 animals used).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The use of animals in the specific areas is similar to the figures of 2015.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

There were no significant changes in actual severities.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

·Funding of research projects for the development of alternative toxicity tests.

·Collaboration with the university board to promote the development and promotion of alternative methods.

·Collaboration between the different regions and other member states to promote the 3R principle.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

40.12% of the fishes are reported under the “other” category. They are mostly Cyprinidae, Cichlidae, Salmonidae, Percidae, Soleidae, Pleuronectidae and Aplocheilidae .

37,28% of the amphibians reported under the “other” category are mostly Ranidae (Lithobates catesbeianus), Salamandridae (in order of importance: Lissotriton helveticus, Pleurodeles waltl, Ichthyosaura alpestris) and Bombinatoridae (Bombina orientalis).

14.65% of the birds are reported under the “other” category. They are Paridae, Fringillidae, Meleagrididae, Phasianidae, Passeridae, Pycnonotidae, Estrildida, Laridae, Columbidae and Psittacidae.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

There were no cases in which the ‘severe’ classification was exceeded.

Belgium: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

336052

62.83%

Rats

30337

5.67%

Guinea-Pigs

16223

3.03%

Hamsters (Syrian)

1880

0.35%

Hamsters (Chinese)

Mongolian gerbil

118

0.02%

Other Rodents

175

0.03%

Rabbits

48036

8.98%

Cats

123

0.02%

Dogs

1529

0.29%

Ferrets

13

0%

Other carnivores

Horses, donkeys and cross-breeds

231

0.04%

Pigs

3630

0.68%

Goats

101

0.02%

Sheep

581

0.11%

Cattle

1279

0.24%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

40

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

153

0.03%

Domestic fowl

26230

4.9%

Other birds

4504

0.84%

Reptiles

172

0.03%

Rana

Xenopus

769

0.14%

Other Amphibians

457

0.09%

Zebra fish

37256

6.97%

Other Fish

24965

4.67%

Cephalopods

Total

534854

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

494820

93.94%

Animals born in the EU but not at a registered breeder

26817

5.09%

Animals born in rest of Europe

48

0.01%

Animals born in rest of world

5034

0.96%

Total

526719

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

4

100%

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

4

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

4

100%

Self-sustaining colony

Total

4

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

283739

53.05%

Translational and applied research

105760

19.77%

Regulatory use and Routine production

132925

24.85%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

1006

0.19%

Preservation of species

6

0%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

8819

1.65%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

2599

0.49%

Total

534854

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

54616

19.25%

Cardiovascular Blood and Lymphatic System

14443

5.09%

Nervous System

56699

19.98%

Respiratory System

6121

2.16%

Gastrointestinal System including Liver

19837

6.99%

Musculoskeletal System

5877

2.07%

Immune System

50140

17.67%

Urogenital/Reproductive System

11536

4.07%

Sensory Organs (skin, eyes and ears)

3772

1.33%

Endocrine System/Metabolism

18300

6.45%

Multisystemic

10342

3.64%

Ethology / Animal Behaviour /Animal Biology

19464

6.86%

Other basic research

12592

4.44%

Total

283739

100.00%


Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

18857

17.83%

Human Infectious Disorders

18443

17.44%

Human Cardiovascular Disorders

920

0.87%

Human Nervous and Mental Disorders

22383

21.16%

Human Respiratory Disorders

3243

3.07%

Human Gastrointestinal Disorders including Liver

1328

1.26%

Human Musculoskeletal Disorders

1047

0.99%

Human Immune Disorders

2329

2.2%

Human Urogenital/Reproductive Disorders

284

0.27%

Human Sensory Organ Disorders (skin, eyes and ears)

3290

3.11%

Human Endocrine/Metabolism Disorders

2634

2.49%

Other Human Disorders

232

0.22%

Animal Diseases and Disorders

12467

11.79%

Animal Welfare

1514

1.43%

Diagnosis of diseases

6481

6.13%

Plant diseases

Non-regulatory toxicology and ecotoxicology

10308

9.75%

Total

105760

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

82222

61.86%

Other efficacy and tolerance testing

3345

2.52%

Toxicity and other safety testing including pharmacology

5467

4.11%

Routine production

41891

31.51%

Total

132925

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

12844

15.62%

Pyrogenicity testing

Batch potency testing

66345

80.69%

Other quality controls

3033

3.69%

Total

82222

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

392

7.17%

Carcinogenicity

Eye irritation/corrosion

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Repeated dose toxicity

964

17.63%

Genotoxicity

83

1.52%

Developmental toxicity

1697

31.04%

Neurotoxicity

30

0.55%

Kinetics

465

8.51%

Ecotoxicity

358

6.55%

Safety testing in food and feed area

1451

26.54%

Target animal safety

8

0.15%

Other toxicity/safety testing

19

0.35%

Total

5467

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

392

100%

Total

392

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

864

89.63%

29 - 90 days

92

9.54%

> 90 days

8

0.83%

Total

964

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

262

73.18%

Chronic toxicity

96

26.82%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

358

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

41781

99.74%

Monoclonal antibody by mouse ascites method

Other product types

110

0.26%

Total

41891

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

115307

86.75%

Legislation on medicinal products for veterinary use and their residues

15187

11.43%

Medical devices legislation

1299

0.98%

Industrial chemicals legislation

195

0.15%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

668

0.5%

Feed legislation including legislation for the safety of target animals, workers and environment

159

0.12%

Cosmetics legislation

Other legislation

110

0.08%

Total

132925

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

118429

89.09%

Legislation satisfying national requirements only [within EU]

19

0.01%

Legislation satisfying Non-EU requirements only

14477

10.89%

Total

132925

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

526723

98.48%

Yes

8131

1.52%

Total

534854

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

21229

3.97%

Mild [up to and including]

297600

55.64%

Moderate

119243

22.29%

Severe

96782

18.1%

Total

534854

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

513065

95.93%

Yes

21789

4.07%

Total

534854

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

408773

76.43%

Genetically altered without a harmful phenotype

108899

20.36%

Genetically altered with a harmful phenotype

17182

3.21%

Total

534854

100.00%

Belgium: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

Compared to 2016 (534.854 animals used), there is an increase of 1.54% in the number of animals used for scientific purposes in 2017 (543.074 animals used) but still a decrease of 3.29% compared to 2015 (561.551 animals used). The increase in 2017 is the result of an increased use of poultry merely in translational and applied research (animal diseases and disorders) and for forensic enquiries.

Number of use in 2017

Number of use in 2016

Number of use in 2015

543074

534854

561551

Since 2015 the numbers of re-used animals continues to decline: 3.74% of all uses in 2015, 1.52% in 2016 and 0.93% in 2017.

Re-Use

Number of use in 2017

Number of use in 2016

Number of use in 2015

No

538043

526723

540571

Yes

5031

8131

20980

Total uses

543074

534854

561551

There is a significant increase in the use of birds (108.94% compared with the use of birds in 2015). This is due to an increase in the area of Animal Diseases and Disorders and Regulatory use and Routine production (Legislation on medicinal products for veterinary use and their residues). The fish decreased with 48,73% compared to 2015. No apparent reason was noted.

Species

Number of use in 2017

Number of use in 2016

Number of use in 2015

Mammals

442378

440501

435333

Birds

46812

30734

22405

Fish

52462

62221

102330

Amphibians

1241

1226

1350

Reptiles

181

172

133

Cephalopods

0

0

0

Total uses

543074

534854

561551

In the mammals the use of rabbits and Artiodactyla increased. The use of rabbits has increased in the Legislation on medicinal products for human use area. This is reflected in an increase of 33.68% compared to 2015. The use of Artiodactyla augmented (61.53% more Artiodactyla used compared to 2015). This is due to an increase in Basic research (this was caused by zootechnics (selection)), Translational and applied research (Animal Diseases and Disorders) and Protection of the natural environment in the interests of the health or welfare of human beings or animals. The use of all other species remained unchanged.

Mammals

Number of use in 2017

Number of use in 2016

Number of use in 2015

Rodents

374857

384785

385298

Rabbits

57888

48036

43304

Carnivores

1943

1665

1937

Equidae

234

231

115

Artiodactyla

7272

5591

4502

Non-human primates

44

40

46

Other mammals

140

153

131

Total uses

442378

440501

435333

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Between 2015 and 2017, basic research diminished with 11,79%. This was in particular due to decreases in the area of Musculoskeletal System, Urogenital/Reproductive System, Multisystemic research, Endocrine System/Metabolism and Respiratory System. However, the research in the domain of the Immune System and Oncology significantly increased between 2015 and 2017.

During the same time period Translational and applied research augmented with 23.77%. We noted a significant increase in Animal Welfare (3,525 animals in 2017 compared to 165 in 2015), Animal Diseases and Disorders, Human Endocrine/Metabolism Disorders, Human Sensory Organ Disorders (skin, eyes and ears), Human Nervous and Mental Disorders and Non-regulatory toxicology and ecotoxicology. A decrease was noted in Diagnosis of diseases and Human Infectious Disorders.



3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Within the actual severities classification we note that the category "severe" decreased from 18.10% in 2016 to 15.61% in 2017.

This is due to a diminution of quality control research (incl. batch safety and potency testing). This percentage is still higher than the European average of 10% but in Belgium a lot of basic research was done with in particular research in the field of Oncology, Immune system and Nervous system. Another important area in the research concerns Translational and applied research with again Human Nervous and Mental Disorders, Human Infectious Disorders and Human Cancer as the most important domains. Since, according to the legislation, tumours leading to metastases, tumours that lead to cachexia, invasive bone tumours, ulcerating tumours, loss of immunity, etc. (research that is often done in Belgium) should be classified as "severe", this can lead to an increase in this category.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

·Funding of research projects for the development of alternative toxicity tests:

-Thyroid hormone disruptors: There is a wide-variety of environmental contaminants that have the potential to cause thyroid hormone disruption 1 . Exposure to specific environmental toxins, including polychlorinated biphenyls, dioxins, phthalates, polybrominated diphenyl ethers (PBDEs), and other halogenated compounds, has been shown to interfere with the production, transportation, and/or metabolism of thyroid hormones by a variety of mechanisms. Some chemicals, with structural similarity to thyroid hormones, have been shown to bind to thyroid receptors with both agonist and antagonist effects on thyroid hormone signalling. Thyroid hormone disruption can therefore cause severe adverse effects on e.g. brain development, growth and metabolism.

Validated and internationally recognised tests methods are essential in assessing the potential of chemicals to interact with the hormonal system and cause adverse effects. Non-animal test methods are needed for efficient testing and screening of substances. In 2014, OECD published a scoping document on in vitro and ex vivo assays for the identification of modulators of thyroid hormone signalling (OECD, 2014). Several key biological mechanisms of thyroid system disruption were reviewed and the corresponding methods evaluated for their state of readiness as candidates to enter the validation process. Relevant in vitro and ex vivo methods were identified and recommendations were given for their development/use. Eighteen methods were reported that cover the possible sites of action in the hypothalamic-pituitary-thyroid (HPT) axis. The research is carried out by EU-Netval facilities. By funding this research we enable our EU NETVAL facility to take part of this study.

-Differentiation of human skin-derived stem cells towards hepatic cells: new source for the "in vitro study" of liver toxicity of drugs. Liver toxicity is one of the most important research elements in drug development. In addition, liver toxicity is the main reason for withdrawing medicines from the market. Presently, pre-clinical drug safety tests are carried out by "in vivo studies", i.e. studies on laboratory animals. In addition to the ethical concerns and the high costs associated with these in vivo studies, it is important to note the relatively low correlation between the results of animals on humans (less than 60% of the results of tests on animals apply to humans). By funding the project, we contribute to research that will lead in the long term to the reduction of the number of laboratory animals that are used in the context of drug development.

·Collaboration with the university board to promote the development and promotion of alternative methods (for example, WALCOPA project in Wallonia).

·Collaboration between the different regions and other member states to promote the 3R principle.

·Establishment of RE-place: The RE-Place project will create a database that brings together all existing expertise on alternative methods for animal testing in the Flemish and Brussels regions. The RE-Place website will be expanded in a next phase into a platform where researchers can find more information about alternative methods for animal testing and share their research methodology with the rest of the research community. By charting and making known generally the available and developing alternative methods for animal testing, not only researchers but also the general public and the political world will be better informed about the expertise in their own region. In the long term, all collected information will be integrated at European level.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

1.Other fish

45.80% of the fishes are reported under the “other” category.

They are mostly Cichlidae (Oreochromis niloticus) (31.21% of other fish), Salmonidae (Salmo salar and Oncorhynchus mykiss) (18.85% of other fish), Anguillidae (Anguilla anguilla) (18.75% of other fish), Cyprinidae (Cyprinus carpio carpio and Cyprinus carpio) (10.27% of other fish), Nothobranchiidae (Nothobranchius furzeri) (7.79% of other fish) and Moronidae (Dicentrarchus labrax) (5.70% of other fish).

Other Fish

Number of uses

Oreochromis niloticus

7499

Anguilla anguilla

4506

Salmo salar

2012

Oncorhynchus mykiss

2522

Nothobranchius furzeri

1871

Cyprinus carpio carpio

1814

Dicentrarchus labrax

1370

Cyprinus carpio

654

Scortum barcoo

648

Poecilia reticulata

300

Pleuronectes platessa

229

Lota lota

144

Gasterosteus aculeatus

82

Clarias gariepinus

50

Kryptolebias marmoratus

50

Limanda limanda

48

Gadus morhua

47

Pseudotropheus saulosi

25

Synodontis grandiops

20

Microsynodontis batesii

12

Myloplus schomburgkii

8

Catoprion mento

7

Metynnis hypsauchen

7

Pseudotropheus estherae

7

Pygopristis denticulata

7

Serrasalmus spilopleura

7

Ophthalmotilapia ventralis

6

Synodontis nigriventris

6

Maylandia zebra

5

Mochokiella paynei

5

Pygocentrus cariba

5

Pygocentrus nattereri

5

Pygocentrus piraya

5

Botia morleti

3

Myloplus rubripinnis

3

Pantodon buchholzi

3

Piaractus brachypomus

3

Synodontis acanthomias

3

Synodontis brichardi

3

Synodontis contractus

3

Synodontis elongatus

3

Synodontis flavitaeniatus

3

Synodontis lucipinnis

3

Synodontis notatus

3

Botia modesta

2

Serrasalmus manueli

2

Colossoma macropomum

1

Malapterurus electricus

1

Metynnis lippincottianus

1

Ophthalmotilapia nasuta

1

Platydoras hancockii

1

Synodontis eupterus

1

Synodontis schall

1

Total uses:

24027

2.Other amphibians

26.03% of the amphibians are reported under the “other” category.

They are mostly Ranidae (Lithobates catesbeianus larva + adult) (57.27% of other amphibians) and Salamandridae (in order of importance: Lissotriton helveticus, Salamandra atra, Salamandra salamandra, Pleurodeles waltl) (40.24% of other amphibians).

Other Amphibians

Number of uses

Lithobates catesbeianus larve

180 

Lissotriton helveticus

58

Salamandra atra

31

Salamandra salamandra

23

Pleurodeles waltl

18

Lithobates catesbeianus adult

5

Dyscophus guineti

4

Phrynomantis microps

3

Xenopus muelleri

1

Total uses:

323

3.Other birds

15.25% of the birds are reported under the “other” category.

They are mostly Paridae (Parus major and Cyanistis caeruleus) (50.89% of other birds) and Phasianidae (Meleagris gallopavo, Coturnix japonica, Coturnix coturnix) (47.42% of other birds).

The other birds are members of Fringillidae (Serinus canaria), Estrildidae (Taeniopygia guttata), Laridae (Larus fuscus), Columbidae (Columba livia), Sturnidae (Sturnus vulgaris) and the Anatidae (Anas platyrhynchos).

Other Birds

Number of uses

Meleagris gallopavo

3249

Parus major

2979

Cyanistis caeruleus

654

Coturnix japonica

119

Serinus canaria

33

Taeniopygia guttata

27

Coturnix coturnix

17

Larus fuscus

17

Columba livia

14

Sturnus vulgaris

13

Anas platyrhynchos

8

Columbidae

8

Total uses:

7138

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

As in previous years, there were no cases in which the ‘severe’ classification was exceeded.

Belgium: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

334054

61.51%

Rats

23826

4.39%

Guinea-Pigs

15541

2.86%

Hamsters (Syrian)

1147

0.21%

Hamsters (Chinese)

Mongolian gerbil

174

0.03%

Other Rodents

115

0.02%

Rabbits

57888

10.66%

Cats

61

0.01%

Dogs

1856

0.34%

Ferrets

26

0%

Other carnivores

Horses, donkeys and cross-breeds

234

0.04%

Pigs

4970

0.92%

Goats

78

0.01%

Sheep

666

0.12%

Cattle

1558

0.29%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

44

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

140

0.03%

Domestic fowl

39674

7.31%

Other birds

7138

1.31%

Reptiles

181

0.03%

Rana

Xenopus

918

0.17%

Other Amphibians

323

0.06%

Zebra fish

28435

5.24%

Other Fish

24027

4.42%

Cephalopods

Total

543074

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

511268

95.03%

Animals born in the EU but not at a registered breeder

22269

4.14%

Animals born in rest of Europe

903

0.17%

Animals born in rest of world

3594

0.67%

Total

538034

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

9

100%

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

9

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

9

100%

Self-sustaining colony

Total

9

100.00%



Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

272795

50.23%

Translational and applied research

117258

21.59%

Regulatory use and Routine production

141853

26.12%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

706

0.13%

Preservation of species

151

0.03%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

8051

1.48%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

2260

0.42%

Total

543074

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

58087

21.29%

Cardiovascular Blood and Lymphatic System

13462

4.93%

Nervous System

42974

15.75%

Respiratory System

3583

1.31%

Gastrointestinal System including Liver

16775

6.15%

Musculoskeletal System

4967

1.82%

Immune System

70105

25.7%

Urogenital/Reproductive System

5852

2.15%

Sensory Organs (skin, eyes and ears)

4785

1.75%

Endocrine System/Metabolism

14861

5.45%

Multisystemic

5600

2.05%

Ethology / Animal Behaviour /Animal Biology

14701

5.39%

Other basic research

17043

6.25%

Total

272795

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

12720

10.85%

Human Infectious Disorders

15691

13.38%

Human Cardiovascular Disorders

1573

1.34%

Human Nervous and Mental Disorders

28936

24.68%

Human Respiratory Disorders

5945

5.07%

Human Gastrointestinal Disorders including Liver

977

0.83%

Human Musculoskeletal Disorders

783

0.67%

Human Immune Disorders

2039

1.74%

Human Urogenital/Reproductive Disorders

503

0.43%

Human Sensory Organ Disorders (skin, eyes and ears)

5441

4.64%

Human Endocrine/Metabolism Disorders

3722

3.17%

Other Human Disorders

40

0.03%

Animal Diseases and Disorders

17960

15.32%

Animal Welfare

3525

3.01%

Diagnosis of diseases

4292

3.66%

Plant diseases

Non-regulatory toxicology and ecotoxicology

13111

11.18%

Total

117258

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

68615

48.37%

Other efficacy and tolerance testing

17201

12.13%

Toxicity and other safety testing including pharmacology

4133

2.91%

Routine production

51904

36.59%

Total

141853

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

8016

11.68%

Pyrogenicity testing

Batch potency testing

57716

84.12%

Other quality controls

2883

4.2%

Total

68615

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1037

25.09%

Carcinogenicity

Eye irritation/corrosion

Genotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Skin irritation/corrosion

Skin sensitisation

Repeated dose toxicity

672

16.26%

Reproductive toxicity

290

7.02%

Developmental toxicity

11

0.27%

Neurotoxicity

20

0.48%

Kinetics

399

9.65%

Ecotoxicity

1418

34.31%

Safety testing in food and feed area

150

3.63%

Target animal safety

136

3.29%

Total

4133

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

50

4.82%

Other lethal methods

Non lethal methods

987

95.18%

Total

1037

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

505

75.15%

29 - 90 days

42

6.25%

> 90 days

125

18.6%

Total

672

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

1202

84.77%

Chronic toxicity

216

15.23%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

1418

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

51804

99.81%

Monoclonal antibody by mouse ascites method

Other product types

100

0.19%

Total

51904

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

113897

80.29%

Legislation on medicinal products for veterinary use and their residues

25559

18.02%

Medical devices legislation

779

0.55%

Industrial chemicals legislation

216

0.15%

Plant protection product legislation

52

0.04%

Biocides legislation

Food legislation including food contact material

74

0.05%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

1276

0.9%

Total

141853

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

128208

90.38%

Legislation satisfying national requirements only [within EU]

50

0.04%

Legislation satisfying Non-EU requirements only

13595

9.58%

Total

141853

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

538043

99.07%

Yes

5031

0.93%

Total

543074

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

26546

4.89%

Mild [up to and including]

297189

54.72%

Moderate

134577

24.78%

Severe

84762

15.61%

Total

543074

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

513454

94.55%

Yes

29620

5.45%

Total

543074

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

402289

74.08%

Genetically altered without a harmful phenotype

118326

21.79%

Genetically altered with a harmful phenotype

22459

4.14%

Total

543074

100.00%



Bulgaria

Bulgaria: Narrative 2015 - no narrative submitted

No narrative submitted by the Member State

Bulgaria : Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

2381

25.17%

Rats

1753

18.53%

Guinea-Pigs

105

1.11%

Hamsters (Syrian)

404

4.27%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

365

3.86%

Cats

46

0.49%

Dogs

10

0.11%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

4

0.04%

Pigs

50

0.53%

Goats

7

0.07%

Sheep

320

3.38%

Cattle

26

0.27%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

1025

10.84%

Other birds

24

0.25%

Reptiles

Rana

2920

30.87%

Xenopus

Other Amphibians

20

0.21%

Zebra fish

Other Fish

Cephalopods

Total

9460

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

8850

99.55%

Animals born in the EU but not at a registered breeder

40

0.45%

Animals born in rest of Europe

Animals born in rest of world

Total

8890

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

4930

52.11%

Translational and applied research

322

3.4%

Regulatory use and Routine production

1000

10.57%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

3208

33.91%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

9460

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

1480

30.02%

Cardiovascular Blood and Lymphatic System

20

0.41%

Nervous System

950

19.27%

Respiratory System

Gastrointestinal System including Liver

242

4.91%

Musculoskeletal System

Immune System

1

0.02%

Urogenital/Reproductive System

3

0.06%

Sensory Organs (skin, eyes and ears)

84

1.7%

Endocrine System/Metabolism

284

5.76%

Multisystemic

624

12.66%

Ethology / Animal Behaviour /Animal Biology

1204

24.42%

Other basic research

38

0.77%

Total

4930

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

100

31.06%

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

4

1.24%

Animal Welfare

Diagnosis of diseases

218

67.7%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

322

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

850

85%

Other efficacy and tolerance testing

Routine production

Toxicity and other safety testing including pharmacology

150

15%

Total

1000

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

700

82.35%

Pyrogenicity testing

150

17.65%

Batch potency testing

Other quality controls

Total

850

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

50

33.33%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Neurotoxicity

100

66.67%

Total

150

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

50

100%

Other lethal methods

Non lethal methods

Total

50

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

900

90%

Legislation on medicinal products for veterinary use and their residues

100

10%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

1000

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

1000

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

1000

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

8890

93.97%

Yes

570

6.03%

Total

9460

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

815

8.62%

Mild [up to and including]

3933

41.58%

Moderate

2508

26.51%

Severe

2204

23.3%

Total

9460

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

9460

100%

Yes

Total

9460

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

9460

100%

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

9460

100.00%

Bulgaria: Narrative 2016 - no narrative submitted

No narrative submitted by the Member State

Bulgaria: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

2015

21.19%

Rats

2047

21.53%

Guinea-Pigs

1860

19.56%

Hamsters (Syrian)

30

0.32%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

689

7.25%

Cats

Dogs

60

0.63%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

300

3.16%

Cattle

6

0.06%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

100

1.05%

Other birds

Reptiles

Rana

2400

25.24%

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

9507

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

9267

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

9267

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

6033

63.46%

Translational and applied research

691

7.27%

Regulatory use and Routine production

180

1.89%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2603

27.38%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

9507

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

30

0.5%

Cardiovascular Blood and Lymphatic System

Nervous System

1529

25.34%

Respiratory System

60

0.99%

Gastrointestinal System including Liver

572

9.48%

Musculoskeletal System

5

0.08%

Immune System

2936

48.67%

Urogenital/Reproductive System

40

0.66%

Sensory Organs (skin, eyes and ears)

10

0.17%

Endocrine System/Metabolism

270

4.48%

Multisystemic

563

9.33%

Ethology / Animal Behaviour /Animal Biology

Other basic research

18

0.3%

Total

6033

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

331

47.9%

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

30

4.34%

Other Human Disorders

74

10.71%

Animal Diseases and Disorders

256

37.05%

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

691

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

130

72.22%

Other efficacy and tolerance testing

Routine production

Toxicity and other safety testing including pharmacology

50

27.78%

Total

180

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

Other quality controls

Pyrogenicity testing

Batch potency testing

130

100%

Total

130

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

50

100%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

50

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

50

100%

Other lethal methods

Non lethal methods

Total

50

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

180

100%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

180

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

180

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

180

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

9267

97.48%

Yes

240

2.52%

Total

9507

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

1474

15.5%

Mild [up to and including]

4016

42.24%

Moderate

1762

18.53%

Severe

2255

23.72%

Total

9507

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

9507

100%

Yes

Total

9507

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

9507

100%

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

9507

100.00%

Bulgaria: Narrative 2017 - no narrative submitted

No narrative submitted by the Member State

Bulgaria: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

989

11.39%

Rats

1892

21.79%

Guinea-Pigs

1841

21.21%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

568

6.54%

Cats

30

0.35%

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

20

0.23%

Goats

Sheep

340

3.92%

Cattle

15

0.17%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

680

7.83%

Other birds

Reptiles

Rana

2306

26.56%

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

8681

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

8651

99.65%

Animals born in the EU but not at a registered breeder

30

0.35%

Animals born in rest of Europe

Animals born in rest of world

Total

8681

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

2246

25.87%

Translational and applied research

19

0.22%

Regulatory use and Routine production

4126

47.53%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2290

26.38%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

8681

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

1651

73.51%

Respiratory System

Gastrointestinal System including Liver

11

0.49%

Musculoskeletal System

74

3.29%

Immune System

42

1.87%

Urogenital/Reproductive System

45

2%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

56

2.49%

Multisystemic

62

2.76%

Ethology / Animal Behaviour /Animal Biology

235

10.46%

Other basic research

70

3.12%

Total

2246

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

19

100%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

19

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

2843

68.9%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

238

5.77%

Routine production

1045

25.33%

Total

4126

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

2843

100%

Batch potency testing

Other quality controls

Pyrogenicity testing

Total

2843

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

38

15.97%

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Pharmaco-dynamics (incl safety pharmacology)

150

63.03%

Ecotoxicity

50

21.01%

Total

238

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

38

100%

Other lethal methods

Non lethal methods

Total

38

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

50

100%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

50

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

1045

100%

Total

1045

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

3081

74.67%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

1045

25.33%

Total

4126

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

4126

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

4126

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

8681

100%

Yes

Total

8681

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

Mild [up to and including]

4547

52.38%

Moderate

3869

44.57%

Severe

265

3.05%

Total

8681

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

8681

100%

Yes

Total

8681

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

8681

100%

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

8681

100.00%



Croatia

Croatia: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

There is an overall decrease in the total number of uses but increase in the use of not genetically altered animals, increase of uses in basic research and decrease in uses for regulatory and routine production. The number of uses for higher education or training for the acquisition, maintenance or improvement of vocational skills is less in number even though it is higher in percentage. There is a significant decrease in testing by legislation and regulatory use and routine production but slightly increase in basic research.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

There is decrease in 2015 in:

- uses (7,53% (1958)) in 2015 when we compare data from 2015 with the data from 2014:

-Testing by legislation – decrease in total – 45,99% (3899)

   - Legislation on medicinal products for human use – 52,73% (1760)

   - Food legislation including food contact material – from 32,87 % in 2014 to 8,40% in 2015

   - Regulatory use and production – decrease in total 45,99 % (3899):

       - Quality control (incl. batch safety and potency testing) – 60,67% (1876)

       - Toxicity and other safety testing including pharmacology – 2091 uses less

- Other quality controls uses (they are specified as a use for Registration purpose (use of
European viper venom antiserum, Equine on dogs), as a method of validation and use
of cock RBCs) in number of uses and also in percentage in 2015 – 33,89% (1993)

There is increase in 2015 in:

   - Regulatory use and Routine production:

– Routine production - 68 uses in 2015 (in 2014 such uses were not reported)

-Toxicity and other safety testing including pharmacology:

oRepeated dose toxicity – 80 uses (in 2014 such uses were not reported)

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Severity of procedures

2014

2015

number

%

number

%

Non-recovery

6543

25,17

3714

16,13

Mild (up to and including)

13 915

53,52

9 273

40,26

Moderate

4 551

17,51

7 994

34,71

Severe

989

3,80

2 051

8,91

Total number

25 998

100

23 032

100

In 2015 (when we compare with 2014) there is:

-an increase of Non-recovery procedures in Basic research but in total it is decrease of Non-recovery procedures (in 2014 it was reported 2659 uses in Basic research, 3445 in Regulatory use and Routine production, 359 in education and 60 in Translation and applied research and in 2015 it was reported 3236 uses in Basic research, nothing in Regulatory use and Routine production, 361 in education and 117 in Translation and applied research)

-an decrease of mild procedures in total

-an increase of moderate procedures in Basic research mainly and in total and

-an increase of severe procedures in Regulatory use and Routine production (in 2014 it was reported 903 uses in Basic research, nothing in Regulatory use and Routine production, 78 in Translation and applied research and 8 in education and in 2015 it was reported 908 uses in Basic research, 1078 in Regulatory use and Routine production and 67 in Translation and applied research)

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

-22 October 2015, 2nd Workshop of the Croatian Society for Laboratory Animal Science, international participation, Implementation of 3R principles, Zagreb, Croatia - for users, breeders, suppliers

-10th October 2015, 2nd Symposium of Croatian Society for the Science of Laboratory Animals 'Experimental Animals in Scientific Research", Zagreb, Croatia - for users, breeders, suppliers

-25th March 2015, Scientific Forum, Application and evaluation of projects and experiments using animal models for scientific purposes, Zagreb - for users, breeders, suppliers

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

See point 2.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The exceeded 'severe' classification was not authorised and also not reported.

Croatia: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

16197

70.32%

Rats

5374

23.33%

Guinea-Pigs

264

1.15%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

472

2.05%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

26

0.11%

Pigs

1

0%

Goats

Sheep

44

0.19%

Cattle

28

0.12%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

626

2.72%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

23032

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

22347

97.65%

Animals born in the EU but not at a registered breeder

538

2.35%

Animals born in rest of Europe

Animals born in rest of world

Total

22885

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

18073

78.47%

Translational and applied research

421

1.83%

Regulatory use and Routine production

3321

14.42%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1217

5.28%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

23032

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

447

2.47%

Cardiovascular Blood and Lymphatic System

412

2.28%

Nervous System

1619

8.96%

Respiratory System

4426

24.49%

Gastrointestinal System including Liver

565

3.13%

Musculoskeletal System

217

1.2%

Immune System

4177

23.11%

Urogenital/Reproductive System

424

2.35%

Sensory Organs (skin, eyes and ears)

431

2.38%

Endocrine System/Metabolism

873

4.83%

Multisystemic

2223

12.3%

Ethology / Animal Behaviour /Animal Biology

28

0.15%

Other basic research

2231

12.34%

Total

18073

100.00%


Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

92

21.85%

Human Nervous and Mental Disorders

108

25.65%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

185

43.94%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

1

0.24%

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

35

8.31%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

421

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

2894

87.14%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

359

10.81%

Routine production

68

2.05%

Total

3321

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

569

19.66%

Pyrogenicity testing

63

2.18%

Batch potency testing

1236

42.71%

Other quality controls

1026

35.45%

Total

2894

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

80

22.28%

Safety testing in food and feed area

279

77.72%

Total

359

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

80

100%

29 - 90 days

> 90 days

Total

80

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

68

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

68

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1964

59.14%

Legislation on medicinal products for veterinary use and their residues

1078

32.46%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

279

8.4%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

3321

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

3321

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

3321

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

22885

99.36%

Yes

147

0.64%

Total

23032

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

3714

16.13%

Mild [up to and including]

9273

40.26%

Moderate

7994

34.71%

Severe

2051

8.91%

Total

23032

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

23032

100%

Yes

Total

23032

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

21756

94.46%

Genetically altered without a harmful phenotype

1143

4.96%

Genetically altered with a harmful phenotype

133

0.58%

Total

23032

100.00%

Croatia: Narrative 2016

This report shows statistical data on the number of animals used for scientific purposes during the year 2016. Report was prepared in accordance with the provisions of Article 54 of Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes and Commission Implementing Decision 2012/707/EU of 14 November 2012 establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes.

1. General information on any changes in trends observed since the previous reporting period.

Data for 2016, in comparison with data from 2014 and 2015:

Purpose

2016

2015

2014

number

%

number

%

number

%

Total number of animals used for scientific purposes

21,901

100

23,032

100

25,998

100

Basic research

19,183

87.59

18,073

78.47

15,024

57.79

Testing by legislation

988

4.51

3,321

14.42

7,220

27.77

Number of genetically altered animals with a harmful phenotype

129

0.59

133

0.58

3,930

15.12

Compared to the data for 2014 and 2015, the data for 2016 shows:

-an overall decrease in the total number of animals used for scientific purposes

-an increase in number of animals used for basic research and

-a decrease in number of genetically altered animals with a harmful phenotype used for scientific purposes.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

When data from 2016 are compared with data from 2015 and 2014, the following is apparent:

-a significant decrease in number of animals used for regulatory use and routine production

-a significant decrease in number of animals used for testing by legislation

-a decrease in number of animals used in non-recovery and mild procedures and significant decrease in number of animals used in severe procedures while the number of animals used in moderate procedures is significantly higher.

-a significant decrease in number of animals used for regulatory use and routine production (Quality control including batch safety and potency testing).



3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Compared to the data for 2014 and 2015, the data for 2016 shows:

Severity of procedures

2016

2015

2014

number

%

number

%

number

%

Non-recovery

3,220

14.70

3,714

16.13

6,543

25.17

Mild (up to and including)

6,875

31.31

9,273

40.26

13,915

53.52

Moderate

11,394

52.03

7,994

34.71

4,551

17.51

Severe

430

1.96

2,051

8.91

989

3.80

Total number

21,901

100

23,032

100

25,998

100

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

-26 – 29th October 2016, Implementation of legislation on the protection of animals used for scientific purposes, Croatian Veterinary Days 2016, Croatia, Scientific – Proffesional conference with International participation – for veterinary inspectors

-24th October 2016, Workshop “Best practice and alternatives to animal experiments in education and training”, Co-organisers Ministry of Agriculture, Animal Friends Croatia and InterNICHE, Zagreb – for users, breeders, suppliers

-4th October 2016, Training “Implementation of legislation on the protection of animals in experiments”, Medicin School of the University of Rijeka, Croatia - for users, breeders, suppliers

-3 May 2016, Presentation on education and training in implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes, Zagreb - for users, breeders, suppliers

- Workshop “Animal Experiment Design” organised by Croatian Laboratory Animal Science Association (CroLASA).

5. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The exceeded 'severe' classification was not authorised and also not reported.

Croatia: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

14976

68.38%

Rats

5762

26.31%

Guinea-Pigs

71

0.32%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

704

3.21%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

27

0.12%

Pigs

2

0.01%

Goats

Sheep

49

0.22%

Cattle

50

0.23%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

260

1.19%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

21901

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

21701

99.59%

Animals born in the EU but not at a registered breeder

89

0.41%

Animals born in rest of Europe

Animals born in rest of world

Total

21790

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

19183

87.59%

Translational and applied research

456

2.08%

Regulatory use and Routine production

988

4.51%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1203

5.49%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

71

0.32%

Total

21901

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

708

3.69%

Cardiovascular Blood and Lymphatic System

510

2.66%

Nervous System

1613

8.41%

Respiratory System

4564

23.79%

Gastrointestinal System including Liver

663

3.46%

Musculoskeletal System

122

0.64%

Immune System

3861

20.13%

Urogenital/Reproductive System

146

0.76%

Sensory Organs (skin, eyes and ears)

1652

8.61%

Endocrine System/Metabolism

397

2.07%

Multisystemic

2673

13.93%

Ethology / Animal Behaviour /Animal Biology

88

0.46%

Other basic research

2186

11.4%

Total

19183

100.00%



Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

70

15.35%

Human Infectious Disorders

Human Cardiovascular Disorders

119

26.1%

Human Nervous and Mental Disorders

60

13.16%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

37

8.11%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

120

26.32%

Other Human Disorders

Animal Diseases and Disorders

50

10.96%

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

456

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

831

84.11%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

98

9.92%

Routine production

59

5.97%

Total

988

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

210

25.27%

Pyrogenicity testing

67

8.06%

Batch potency testing

194

23.35%

Other quality controls

360

43.32%

Total

831

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

88

89.8%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

4

4.08%

Kinetics

6

6.12%

Total

98

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

88

100%

Total

88

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

4

100%

29 - 90 days

> 90 days

Total

4

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

59

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

59

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

618

62.55%

Legislation on medicinal products for veterinary use and their residues

364

36.84%

Medical devices legislation

6

0.61%

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

988

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

988

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

988

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

21790

99.49%

Yes

111

0.51%

Total

21901

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

3220

14.7%

Mild [up to and including]

6857

31.31%

Moderate

11394

52.03%

Severe

430

1.96%

Total

21901

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

21901

100%

Yes

Total

21901

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

19422

88.68%

Genetically altered without a harmful phenotype

2350

10.73%

Genetically altered with a harmful phenotype

129

0.59%

Total

21901

100.00%

Croatia: Narrative 2017

This report shows statistical data on the number of animals used for scientific purposes during the year 2017. Report was prepared in accordance with the provisions of Article 54 of Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes and Commission Implementing Decision 2012/707/EU of 14 November 2012 establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes.

1.General information on any changes in trends observed since the previous reporting periods.

1)Animal Species used for scientific procedures

Data for 2017, 2016, 2015 and 2014:

Animal Species

2017

2016

2015

2014

number

%

number

%

number

%

number

%

Mice

19,806

69.41

14,976

68.38

16,197

70.32

19,427

74.72

Rats

7,700

26.99

5,762

26.31

5,374

23.33

4,962

19.09

Guinea Pigs

21

0.07

71

0.32

264

1.15

488

1.88

Rabbits

426

1,49

704

3.21

472

2.05

331

1.27

Horses, donkeys and cross-breeds

25

0.09

27

0.12

26

0.11

0

0

Pigs

2

0.01

2

0.01

1

0.00

0

0

Sheep

39

0.14

49

0.22

44

0.19

18

0.07

Cattle

30

0.11

50

0.23

28

0.12

0

0

Domestic fowl

255

0.89

260

1.19

626

2.72

772

2.97

Zebra fish

230

0.81

0

0

0

0

0

0

SUMMARY

28,534

100

21,901

100

23,032

100

25,998

100

Compared to the data for 2014, 2015 and 2016, the data for 2017 shows:

-an overall decrease in the total number of animals used for scientific purposes and most in mice and rats

-Zebra fish as new animal model has been reported

2)Information on any changes in trends in Purpose

Compared to the data for 2014, 2015 and 2016, the data for 2017 shows:

Purpose

2017

2016

2015

2014

number

%

number

%

number

%

number

%

Total number of animals used for scientific purposes

28,534

100

21,901

100

23,032

100

25,998

100

Basic research

22,067

77.36

19,183

87.59

18,073

78.47

15,024

57.79

Translational and applied research

2,761

9,68

456

2,08

421

1.83

671

2.58

Regulatory use and routine production

2,182

7.65

988

4.51

3,321

14.42

7,220

27.77

Higher education or training for acquisition, maintenance or improvement of vocational skills

1,428

5,01

1,203

5,49

1,217

5.28

0

0

Maintenance of colonies of established genetically altered animals, not used in other procedures

96

0,34

71

0,32

0

0

0

0

Compared to the data for 2014, 2015 and 2016, the data for 2017 shows:

-an increase in the total number of animals used for basic and translational/applied research and regulatory use and routine production

-in 2017 and 2016 the data for maintenance of colonies of established genetically altered animals, not used in other procedures have been reported.

2.Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

When data from 2017 are compared with the data from 2016, 2015 and 2014, the following is apparent:

-a significant increase in the total number of animals used for translational/applied research and regulatory use and routine production

-an overall decrease in the total number of rabbits and domestic fowl used for scientific purposes

-increase of number of animals not used for creation of new GL

-for the first time use of animals for use for creation of new GL reported

-increase of number of not genetically altered animals and genetically altered animals without a harmful phenotype

-decrease of number of animals genetically altered with a harmful phenotype

-no animals in pyrogenicity testing are reported

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

Compared to the data for 2014, 2015 and 2016, the data for 2017 shows:

Severity of procedures

2017

2016

2015

2014

number

%

number

%

number

%

number

%

Non-recovery

3,005

10.53

3,220

14.70

3,714

16.13

6,543

25.17

Mild (up to and including)

8,338

29.22

6,875

31.31

9,273

40.26

13,915

53.52

Moderate

11,593

40.63

11,394

52.03

7,994

34.71

4,551

17.51

Severe

5,598

19.62

430

1.96

2,051

8.91

989

3.80

Total number

28,534

100

21,901

100

23,032

100

25,998

100

-an increase in number of animals used in mild and severe procedures but in percentage there is a decrease in all categories except in “severe” where the significant increase is reported

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

-2nd  Workshop “Animal Experiment Design” organised by Croatian Laboratory Animal Science Association (CroLASA), 19-20 October 2017

-Workshop "How to submit an experiment on animals for approval", 2017

5.Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The exceeded 'severe' classification was not authorised and also not reported.

Croatia: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

19806

69.41%

Rats

7700

26.99%

Guinea-Pigs

21

0.07%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

426

1.49%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

25

0.09%

Pigs

2

0.01%

Goats

Sheep

39

0.14%

Cattle

30

0.11%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

255

0.89%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

230

0.81%

Other Fish

Cephalopods

Total

28534

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

28292

99.51%

Animals born in the EU but not at a registered breeder

60

0.21%

Animals born in rest of Europe

Animals born in rest of world

79

0.28%

Total

28431

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total



Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

22067

77.34%

Translational and applied research

2761

9.68%

Regulatory use and Routine production

2182

7.65%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1428

5%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

96

0.34%

Total

28534

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

1345

6.1%

Cardiovascular Blood and Lymphatic System

378

1.71%

Nervous System

1428

6.47%

Respiratory System

5721

25.93%

Gastrointestinal System including Liver

2069

9.38%

Musculoskeletal System

30

0.14%

Immune System

3764

17.06%

Urogenital/Reproductive System

234

1.06%

Sensory Organs (skin, eyes and ears)

688

3.12%

Endocrine System/Metabolism

384

1.74%

Multisystemic

4582

20.76%

Ethology / Animal Behaviour /Animal Biology

122

0.55%

Other basic research

1322

5.99%

Total

22067

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

230

8.33%

Human Infectious Disorders

1394

50.49%

Human Cardiovascular Disorders

510

18.47%

Human Nervous and Mental Disorders

214

7.75%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

28

1.01%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

60

2.17%

Other Human Disorders

Animal Diseases and Disorders

30

1.09%

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

295

10.68%

Total

2761

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1585

72.64%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

556

25.48%

Routine production

41

1.88%

Total

2182

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

262

16.53%

Pyrogenicity testing

Batch potency testing

128

8.08%

Other quality controls

1195

75.39%

Total

1585

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

556

100%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

556

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

556

100%

Total

556

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

41

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

41

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1799

82.45%

Legislation on medicinal products for veterinary use and their residues

383

17.55%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

2182

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2182

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

2182

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

28431

99.64%

Yes

103

0.36%

Total

28534

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

3005

10.53%

Mild [up to and including]

8338

29.22%

Moderate

11593

40.63%

Severe

5598

19.62%

Total

28534

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

28304

99.19%

Yes

230

0.81%

Total

28534

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

26027

91.21%

Genetically altered without a harmful phenotype

2452

8.59%

Genetically altered with a harmful phenotype

55

0.19%

Total

28534

100.00%



Cyprus

Cyprus: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

-

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

There was a significant increase in the use of animals in 2015 (almost doubled) due to the improvement of the economic situation in Cyprus that resulted in increased funds for research.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

-

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

-

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

-

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

-

Cyprus: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1141

100%

Rats

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

1141

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1141

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

1141

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

685

60.04%

Translational and applied research

456

39.96%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

1141

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

126

18.39%

Cardiovascular Blood and Lymphatic System

Nervous System

476

69.49%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

83

12.12%

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

685

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

215

47.15%

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

241

52.85%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

456

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total



First uses and re-uses

Re-use

Number of uses

Percentage

No

1141

100%

Yes

Total

1141

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

110

9.64%

Mild [up to and including]

700

61.35%

Moderate

331

29.01%

Severe

Total

1141

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1141

100%

Yes

Total

1141

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

607

53.2%

Genetically altered without a harmful phenotype

434

38.04%

Genetically altered with a harmful phenotype

100

8.76%

Total

1141

100.00%



Cyprus: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

-

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

There was a slight expected increase in the number of animal use in 2016 due to the further improvement of the economic situation in Cyprus.

-

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

-

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

-

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

-

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

-

Cyprus: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1448

100%

Rats

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

1448

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1448

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

1448

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

927

64.02%

Translational and applied research

521

35.98%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

1448

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

108

11.65%

Cardiovascular Blood and Lymphatic System

Nervous System

350

37.76%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

250

26.97%

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

180

19.42%

Endocrine System/Metabolism

39

4.21%

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

927

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

404

77.54%

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

117

22.46%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

521

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

1448

100%

Yes

Total

1448

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

Mild [up to and including]

1244

85.91%

Moderate

204

14.09%

Severe

Total

1448

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1448

100%

Yes

Total

1448

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

789

54.49%

Genetically altered without a harmful phenotype

659

45.51%

Genetically altered with a harmful phenotype

Total

1448

100.00%

Cyprus: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

-

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In general there were no significant changes in the numbers of animals used since the previous reporting periods.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

-

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

-

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

-

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

-

Cyprus: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1209

100%

Rats

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

1209

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1209

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

1209

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

839

69.4%

Translational and applied research

370

30.6%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

1209

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

129

15.38%

Cardiovascular Blood and Lymphatic System

17

2.03%

Nervous System

368

43.86%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

275

32.78%

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

50

5.96%

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

839

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

370

100%

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

370

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

1209

100%

Yes

Total

1209

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

Mild [up to and including]

1197

99.01%

Moderate

12

0.99%

Severe

Total

1209

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1209

100%

Yes

Total

1209

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

623

51.53%

Genetically altered without a harmful phenotype

586

48.47%

Genetically altered with a harmful phenotype

Total

1209

100.00%



Czechia

Czechia: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

The statistical data has been collected since 1993 in the Czech Republic. In 2015 statistical data there are no changes in trends observed since the previous reporting periods.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

There is no significant increase or decrease in use animals in any of the specific areas.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

There are no changes in actual severity.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

There are no impacts of principle of 3Rs on 2015 statistical data. We are expecting this impact in subsequent years.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Categories “other” has been used where is appropriate. When “other” has been used, “specify other” has been always fulfilled.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Classification “severe” is not exceeded in 2015 statistical data.

Czechia: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

73415

31.94%

Rats

24200

10.53%

Guinea-Pigs

1008

0.44%

Hamsters (Syrian)

48

0.02%

Hamsters (Chinese)

Mongolian gerbil

18

0.01%

Other Rodents

988

0.43%

Rabbits

4840

2.11%

Cats

341

0.15%

Dogs

1135

0.49%

Ferrets

154

0.07%

Other carnivores

10

0%

Horses, donkeys and cross-breeds

113

0.05%

Pigs

2118

0.92%

Goats

318

0.14%

Sheep

1468

0.64%

Cattle

1941

0.84%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

6

0%

Rhesus monkey

51

0.02%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

36

0.02%

Domestic fowl

22962

9.99%

Other birds

3003

1.31%

Reptiles

453

0.2%

Rana

100

0.04%

Xenopus

135

0.06%

Other Amphibians

675

0.29%

Zebra fish

2729

1.19%

Other Fish

87604

38.11%

Cephalopods

Total

229869

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

197689

87.69%

Animals born in the EU but not at a registered breeder

27419

12.16%

Animals born in rest of Europe

Animals born in rest of world

334

0.15%

Total

225442

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

85456

37.18%

Translational and applied research

26835

11.67%

Regulatory use and Routine production

61272

26.66%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

40441

17.59%

Preservation of species

176

0.08%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

15673

6.82%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

16

0.01%

Total

229869

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

12911

15.11%

Cardiovascular Blood and Lymphatic System

7180

8.4%

Nervous System

13447

15.74%

Respiratory System

314

0.37%

Gastrointestinal System including Liver

1862

2.18%

Musculoskeletal System

509

0.6%

Immune System

11136

13.03%

Urogenital/Reproductive System

8142

9.53%

Sensory Organs (skin, eyes and ears)

549

0.64%

Endocrine System/Metabolism

3889

4.55%

Multisystemic

5835

6.83%

Ethology / Animal Behaviour /Animal Biology

8909

10.43%

Other basic research

10773

12.61%

Total

85456

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

1631

6.08%

Human Infectious Disorders

541

2.02%

Human Cardiovascular Disorders

426

1.59%

Human Nervous and Mental Disorders

803

2.99%

Human Respiratory Disorders

12

0.04%

Human Gastrointestinal Disorders including Liver

45

0.17%

Human Musculoskeletal Disorders

79

0.29%

Human Immune Disorders

219

0.82%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

30

0.11%

Human Endocrine/Metabolism Disorders

1183

4.41%

Other Human Disorders

60

0.22%

Animal Diseases and Disorders

7189

26.79%

Animal Welfare

7541

28.1%

Diagnosis of diseases

6913

25.76%

Plant diseases

Non-regulatory toxicology and ecotoxicology

163

0.61%

Total

26835

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

11354

18.53%

Other efficacy and tolerance testing

219

0.36%

Toxicity and other safety testing including pharmacology

29613

48.33%

Routine production

20086

32.78%

Total

61272

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1742

15.34%

Pyrogenicity testing

72

0.63%

Batch potency testing

9354

82.39%

Other quality controls

186

1.64%

Total

11354

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

3091

10.44%

Skin irritation/corrosion

12

0.04%

Skin sensitisation

568

1.92%

Eye irritation/corrosion

9

0.03%

Repeated dose toxicity

1532

5.17%

Carcinogenicity

Neurotoxicity

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Target animal safety

Genotoxicity

109

0.37%

Reproductive toxicity

1256

4.24%

Developmental toxicity

658

2.22%

Kinetics

554

1.87%

Ecotoxicity

21394

72.25%

Safety testing in food and feed area

72

0.24%

Other toxicity/safety testing

358

1.21%

Total

29613

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

1650

53.38%

Other lethal methods

1435

46.43%

Non lethal methods

6

0.19%

Total

3091

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

782

51.04%

29 - 90 days

540

35.25%

> 90 days

210

13.71%

Total

1532

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

19257

90.01%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

2137

9.99%

Total

21394

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

899

4.48%

Monoclonal antibody by mouse ascites method

Other product types

19187

95.52%

Total

20086

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

3476

5.67%

Legislation on medicinal products for veterinary use and their residues

29178

47.62%

Medical devices legislation

1320

2.15%

Industrial chemicals legislation

2685

4.38%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

817

1.33%

Feed legislation including legislation for the safety of target animals, workers and environment

12

0.02%

Cosmetics legislation

Other legislation

23784

38.82%

Total

61272

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

49869

81.39%

Legislation satisfying national requirements only [within EU]

11403

18.61%

Legislation satisfying Non-EU requirements only

Total

61272

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

225442

98.07%

Yes

4427

1.93%

Total

229869

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

21573

9.38%

Mild [up to and including]

124277

54.06%

Moderate

60578

26.35%

Severe

23441

10.2%

Total

229869

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

221507

96.36%

Yes

8362

3.64%

Total

229869

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

204049

88.77%

Genetically altered without a harmful phenotype

24009

10.44%

Genetically altered with a harmful phenotype

1811

0.79%

Total

229869

100.00%



Czechia: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

The statistical data has been collected since 1993 in the Czech Republic. In 2016 statistical data there are no changes in trends observed since the previous reporting periods.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

There is no significant increase or decrease in use animals in any of the specific areas.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

There are no changes in actual severity.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

There are no impacts of principle of 3Rs on 2016 statistical data. We are expecting this impact in subsequent years.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Categories “other” has been used where is appropriate. When “other” has been used, “specify other” has been always fulfilled.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Classification “severe” is not exceeded in 2016 statistical data.

Czechia: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

78249

32.92%

Rats

30323

12.76%

Guinea-Pigs

1202

0.51%

Hamsters (Syrian)

82

0.03%

Hamsters (Chinese)

Mongolian gerbil

30

0.01%

Other Rodents

1122

0.47%

Rabbits

6834

2.88%

Cats

240

0.1%

Dogs

797

0.34%

Ferrets

42

0.02%

Other carnivores

53

0.02%

Horses, donkeys and cross-breeds

155

0.07%

Pigs

2173

0.91%

Goats

48

0.02%

Sheep

1032

0.43%

Cattle

2978

1.25%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

9

0%

Rhesus monkey

26

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

37

0.02%

Domestic fowl

27261

11.47%

Other birds

3124

1.31%

Reptiles

915

0.39%

Rana

Xenopus

58

0.02%

Other Amphibians

819

0.34%

Zebra fish

4495

1.89%

Other Fish

75558

31.79%

Cephalopods

Total

237662

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

212176

90.81%

Animals born in the EU but not at a registered breeder

21429

9.17%

Animals born in rest of Europe

Animals born in rest of world

51

0.02%

Total

233656

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

87751

36.92%

Translational and applied research

25941

10.92%

Regulatory use and Routine production

74739

31.45%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

32752

13.78%

Preservation of species

228

0.1%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

16143

6.79%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

108

0.05%

Total

237662

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

11267

12.84%

Cardiovascular Blood and Lymphatic System

12055

13.74%

Nervous System

12066

13.75%

Respiratory System

1511

1.72%

Gastrointestinal System including Liver

2348

2.68%

Musculoskeletal System

46

0.05%

Immune System

7811

8.9%

Urogenital/Reproductive System

9041

10.3%

Sensory Organs (skin, eyes and ears)

750

0.85%

Endocrine System/Metabolism

4128

4.7%

Multisystemic

4223

4.81%

Ethology / Animal Behaviour /Animal Biology

7278

8.29%

Other basic research

15227

17.35%

Total

87751

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

3288

12.67%

Human Infectious Disorders

905

3.49%

Human Cardiovascular Disorders

969

3.74%

Human Nervous and Mental Disorders

674

2.6%

Human Respiratory Disorders

12

0.05%

Human Gastrointestinal Disorders including Liver

137

0.53%

Human Musculoskeletal Disorders

93

0.36%

Human Immune Disorders

368

1.42%

Human Urogenital/Reproductive Disorders

551

2.12%

Human Sensory Organ Disorders (skin, eyes and ears)

39

0.15%

Human Endocrine/Metabolism Disorders

1191

4.59%

Other Human Disorders

107

0.41%

Animal Diseases and Disorders

5469

21.08%

Animal Welfare

3611

13.92%

Diagnosis of diseases

8227

31.71%

Plant diseases

Non-regulatory toxicology and ecotoxicology

300

1.16%

Total

25941

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

17569

23.51%

Other efficacy and tolerance testing

316

0.42%

Toxicity and other safety testing including pharmacology

36408

48.71%

Routine production

20446

27.36%

Total

74739

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1574

8.96%

Pyrogenicity testing

51

0.29%

Batch potency testing

15636

89%

Other quality controls

308

1.75%

Total

17569

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

14946

41.05%

Carcinogenicity

Genotoxicity

Neurotoxicity

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Skin irritation/corrosion

Skin sensitisation

570

1.57%

Eye irritation/corrosion

3

0.01%

Repeated dose toxicity

958

2.63%

Reproductive toxicity

5497

15.1%

Developmental toxicity

127

0.35%

Kinetics

511

1.4%

Ecotoxicity

13552

37.22%

Safety testing in food and feed area

40

0.11%

Target animal safety

12

0.03%

Other toxicity/safety testing

192

0.53%

Total

36408

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

12250

81.96%

Other lethal methods

2668

17.85%

Non lethal methods

28

0.19%

Total

14946

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

538

56.16%

29 - 90 days

420

43.84%

> 90 days

Total

958

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

12132

89.52%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

1420

10.48%

Total

13552

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

838

4.1%

Monoclonal antibody by mouse ascites method

Other product types

19608

95.9%

Total

20446

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

3069

4.11%

Legislation on medicinal products for veterinary use and their residues

35721

47.79%

Medical devices legislation

1110

1.49%

Industrial chemicals legislation

6746

9.03%

Plant protection product legislation

Biocides legislation

5

0.01%

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

28088

37.58%

Total

74739

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

51716

69.2%

Legislation satisfying national requirements only [within EU]

23023

30.8%

Legislation satisfying Non-EU requirements only

Total

74739

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

233656

98.31%

Yes

4006

1.69%

Total

237662

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

23268

9.79%

Mild [up to and including]

87633

36.87%

Moderate

77641

32.67%

Severe

49120

20.67%

Total

237662

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

224531

94.47%

Yes

13131

5.53%

Total

237662

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

205032

86.27%

Genetically altered without a harmful phenotype

30738

12.93%

Genetically altered with a harmful phenotype

1892

0.8%

Total

237662

100.00%



Czechia: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

The statistical data has been collected since 1993 in the Czech Republic. In the last three years appears trend increasing number of animal used for preservation of species, in year 2017 is the number of these animals more significant than 2 years ago. In 2017 statistical data there are no other changes in trends observed since the previous reporting periods.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

There is no significant increase or decrease in use animals in any of the specific areas.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

There are no changes in trends in actual severity.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

There are no impacts of principle of 3Rs on 2017 statistical data. We are expecting this impact in subsequent years.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Categories “other” has been used where is appropriate. When “other” has been used, “specify other” has been always fulfilled.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Classification “severe” is not exceeded in 2017 statistical data.

Czechia: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

82219

34.02%

Rats

26967

11.16%

Guinea-Pigs

1383

0.57%

Hamsters (Syrian)

15

0.01%

Hamsters (Chinese)

Mongolian gerbil

46

0.02%

Other Rodents

635

0.26%

Rabbits

2133

0.88%

Cats

132

0.05%

Dogs

637

0.26%

Ferrets

1

0%

Other carnivores

1

0%

Horses, donkeys and cross-breeds

105

0.04%

Pigs

2447

1.01%

Goats

97

0.04%

Sheep

918

0.38%

Cattle

2734

1.13%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

21217

8.78%

Other birds

4260

1.76%

Reptiles

558

0.23%

Rana

Xenopus

50

0.02%

Other Amphibians

531

0.22%

Zebra fish

19765

8.18%

Other Fish

74861

30.97%

Cephalopods

Total

241712

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

213502

95.63%

Animals born in the EU but not at a registered breeder

9222

4.13%

Animals born in rest of Europe

Animals born in rest of world

539

0.24%

Total

223263

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

100107

41.42%

Translational and applied research

27657

11.44%

Regulatory use and Routine production

54133

22.4%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

47646

19.71%

Preservation of species

6437

2.66%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

5732

2.37%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

241712

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

8918

8.91%

Cardiovascular Blood and Lymphatic System

22979

22.95%

Nervous System

9106

9.1%

Respiratory System

503

0.5%

Gastrointestinal System including Liver

1727

1.73%

Musculoskeletal System

484

0.48%

Immune System

13127

13.11%

Urogenital/Reproductive System

12105

12.09%

Sensory Organs (skin, eyes and ears)

525

0.52%

Endocrine System/Metabolism

3777

3.77%

Multisystemic

6311

6.3%

Ethology / Animal Behaviour /Animal Biology

7542

7.53%

Other basic research

13003

12.99%

Total

100107

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

3761

13.6%

Human Infectious Disorders

1309

4.73%

Human Cardiovascular Disorders

1308

4.73%

Human Nervous and Mental Disorders

2009

7.26%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

861

3.11%

Human Musculoskeletal Disorders

114

0.41%

Human Immune Disorders

303

1.1%

Human Urogenital/Reproductive Disorders

496

1.79%

Human Sensory Organ Disorders (skin, eyes and ears)

112

0.4%

Human Endocrine/Metabolism Disorders

2066

7.47%

Other Human Disorders

379

1.37%

Animal Diseases and Disorders

3643

13.17%

Animal Welfare

3914

14.15%

Diagnosis of diseases

7373

26.66%

Plant diseases

Non-regulatory toxicology and ecotoxicology

9

0.03%

Total

27657

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

12209

22.55%

Other efficacy and tolerance testing

326

0.6%

Toxicity and other safety testing including pharmacology

25293

46.72%

Routine production

16305

30.12%

Total

54133

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

523

4.28%

Pyrogenicity testing

81

0.66%

Batch potency testing

11397

93.35%

Other quality controls

208

1.7%

Total

12209

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

4646

18.37%

Carcinogenicity

Genotoxicity

Neurotoxicity

Phototoxicity

Skin irritation/corrosion

Skin sensitisation

637

2.52%

Eye irritation/corrosion

18

0.07%

Repeated dose toxicity

1440

5.69%

Reproductive toxicity

3136

12.4%

Developmental toxicity

274

1.08%

Kinetics

144

0.57%

Pharmaco-dynamics (incl safety pharmacology)

24

0.09%

Ecotoxicity

14374

56.83%

Safety testing in food and feed area

438

1.73%

Target animal safety

50

0.2%

Other toxicity/safety testing

112

0.44%

Total

25293

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

994

21.39%

Other lethal methods

3652

78.61%

Non lethal methods

Total

4646

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

482

33.47%

29 - 90 days

552

38.33%

> 90 days

406

28.19%

Total

1440

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

12714

88.45%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

1660

11.55%

Total

14374

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

777

4.77%

Monoclonal antibody by mouse ascites method

230

1.41%

Other product types

15298

93.82%

Total

16305

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

2682

4.95%

Legislation on medicinal products for veterinary use and their residues

27478

50.76%

Medical devices legislation

1411

2.61%

Industrial chemicals legislation

4345

8.03%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

170

0.31%

Feed legislation including legislation for the safety of target animals, workers and environment

525

0.97%

Cosmetics legislation

Other legislation

17522

32.37%

Total

54133

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

44484

82.18%

Legislation satisfying national requirements only [within EU]

9649

17.82%

Legislation satisfying Non-EU requirements only

Total

54133

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

223263

92.37%

Yes

18449

7.63%

Total

241712

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

19114

7.91%

Mild [up to and including]

110130

45.56%

Moderate

96317

39.85%

Severe

16151

6.68%

Total

241712

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

216026

89.37%

Yes

25686

10.63%

Total

241712

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

199255

82.43%

Genetically altered without a harmful phenotype

39574

16.37%

Genetically altered with a harmful phenotype

2883

1.19%

Total

241712

100.00%



Denmark

Denmark: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period

Although the number of animals reported in Denmark has been declining for many years, and the total number for 2014 , reported only about 200.000 animals, the number reported for 2015 has increased to about 242.000 animals. This number is almost identical to the number of animals reported for 2013. However, the number for 2014 cannot be compared to previous years, as the reporting format has been changed. These data for 2015 suggest that the number of animals used for research has stabilized around 240.000 animals.

The number of pigs has increased significantly in 2015. The increase is primarily caused by an increase in research using pigs as animal models for human diseases. Also the number of cats has increased significantly in 2015. This is caused by clinical studies in treatment of type-2 diabetes in cats. The number of fish has also increased significantly in 2015. This is primarily caused by an increase in research in aqua cultures. Furthermore in a small country with a small scientific community, the change of focus in one or a few research groups can have a significant impact on the statistics for the whole country.

2. Information on significant increase or decrease in used animals in any of the specific areas and analysis of the reasons thereof

No major significant changes are visible in the statistics from 2015

3. Information on any changes in trends in actual severities and analysis of the reasons thereof

In general only few experiments with severe strain are licensed. This is reflected in that the actual reported severity is 0.89%. This is a decrease compared to 1.5% reported for 2014.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Denmark has established a 3R-center operating from 2014. The centre is funding 3R-research, collection and dissemination information on the 3R´s and establishing initiatives to analyze and implement 3R-strategies. Read more here: http://en.3rcenter.dk/

Furthermore the Danish National Committee strongly supports and collaborates with the animal welfare bodies, i.e. yearly meeting for all bodies, hands on exchange of best practice between institutions and companies and best practice guideline. Visit the website: Danish National Committee  

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category

As Denmark has a relatively large production of trout, the species is commonly used in research. Hence it would be a good idea with a specific category for trout. Furthermore Denmark also has a large mink industry, and this species too is often used in research. A specific category for mink will also be appreciated.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The classification “severe” has not been exceeded in 2015 in Denmark.

Denmark: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

155141

63.64%

Rats

48614

19.94%

Guinea-Pigs

2643

1.08%

Hamsters (Syrian)

172

0.07%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

86

0.04%

Rabbits

1665

0.68%

Cats

59

0.02%

Dogs

157

0.06%

Ferrets

Other carnivores

886

0.36%

Horses, donkeys and cross-breeds

115

0.05%

Pigs

10576

4.34%

Goats

11

0%

Sheep

47

0.02%

Cattle

534

0.22%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

38

0.02%

Domestic fowl

2407

0.99%

Other birds

438

0.18%

Reptiles

265

0.11%

Rana

Xenopus

64

0.03%

Other Amphibians

26

0.01%

Zebra fish

2530

1.04%

Other Fish

17318

7.1%

Cephalopods

Total

243792

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

205674

85.32%

Animals born in the EU but not at a registered breeder

27687

11.49%

Animals born in rest of Europe

1311

0.54%

Animals born in rest of world

6397

2.65%

Total

241069

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

88453

36.28%

Translational and applied research

123439

50.63%

Regulatory use and Routine production

22956

9.42%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

2660

1.09%

Preservation of species

258

0.11%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

6023

2.47%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

3

0%

Total

243792

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

5382

6.08%

Cardiovascular Blood and Lymphatic System

4860

5.49%

Nervous System

15725

17.78%

Respiratory System

1262

1.43%

Gastrointestinal System including Liver

2539

2.87%

Musculoskeletal System

2682

3.03%

Immune System

29246

33.06%

Urogenital/Reproductive System

2623

2.97%

Sensory Organs (skin, eyes and ears)

1503

1.7%

Endocrine System/Metabolism

12561

14.2%

Multisystemic

883

1%

Ethology / Animal Behaviour /Animal Biology

4924

5.57%

Other basic research

4263

4.82%

Total

88453

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

9115

7.38%

Human Infectious Disorders

4683

3.79%

Human Cardiovascular Disorders

1404

1.14%

Human Nervous and Mental Disorders

35568

28.81%

Human Respiratory Disorders

75

0.06%

Human Gastrointestinal Disorders including Liver

258

0.21%

Human Musculoskeletal Disorders

400

0.32%

Human Immune Disorders

10037

8.13%

Human Urogenital/Reproductive Disorders

66

0.05%

Human Sensory Organ Disorders (skin, eyes and ears)

852

0.69%

Human Endocrine/Metabolism Disorders

39839

32.27%

Other Human Disorders

9137

7.4%

Animal Diseases and Disorders

7934

6.43%

Animal Welfare

3248

2.63%

Diagnosis of diseases

682

0.55%

Plant diseases

Non-regulatory toxicology and ecotoxicology

141

0.11%

Total

123439

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

14819

64.55%

Other efficacy and tolerance testing

95

0.41%

Toxicity and other safety testing including pharmacology

8021

34.94%

Routine production

21

0.09%

Total

22956

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

3687

24.88%

Pyrogenicity testing

Batch potency testing

11105

74.94%

Other quality controls

27

0.18%

Total

14819

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

786

9.8%

Skin irritation/corrosion

12

0.15%

Skin sensitisation

138

1.72%

Eye irritation/corrosion

6

0.07%

Repeated dose toxicity

1755

21.88%

Carcinogenicity

Developmental toxicity

Genotoxicity

Neurotoxicity

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Kinetics

2095

26.12%

Pharmaco-dynamics (incl safety pharmacology)

9

0.11%

Ecotoxicity

3080

38.4%

Target animal safety

120

1.5%

Other toxicity/safety testing

20

0.25%

Total

8021

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

80

10.18%

Other lethal methods

Non lethal methods

706

89.82%

Total

786

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

1136

64.73%

29 - 90 days

488

27.81%

> 90 days

131

7.46%

Total

1755

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

3080

100%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

3080

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

21

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

21

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

19630

85.51%

Legislation on medicinal products for veterinary use and their residues

142

0.62%

Medical devices legislation

24

0.1%

Industrial chemicals legislation

1360

5.92%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

1800

7.84%

Total

22956

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

21134

92.06%

Legislation satisfying national requirements only [within EU]

1822

7.94%

Legislation satisfying Non-EU requirements only

Total

22956

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

241069

98.88%

Yes

2723

1.12%

Total

243792

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

21199

8.7%

Mild [up to and including]

136701

56.07%

Moderate

83727

34.34%

Severe

2165

0.89%

Total

243792

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

238948

98.01%

Yes

4844

1.99%

Total

243792

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

204237

83.78%

Genetically altered without a harmful phenotype

26191

10.74%

Genetically altered with a harmful phenotype

13364

5.48%

Total

243792

100.00%

Denmark: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period

The overall number at animals used for scientific purposes in Denmark in 2016 is 253.546. In 2015 the same number was 244.411animals. This strengthens a trend, that the number of animals used in Denmark has been relatively stable over the last years.

As usually, mice, rats and fish covers more than 90 % of the animals, but the number of fish has increased a lot, going from 19.848 to 51.659. See 2. for further specification. At the same time, the number of mice and rats has decreased by 10 %.

The percentage of animals used for basic research has increased from 36 % to 41 %. This is due to the fact, that increased number of fish primarily has been used in basic research.

Animals used for regulatory purposes and for routine production have decreased from 9 % to less than
6 %.

Finally the number of animals experiencing severe suffering has doubled in 2016, still being on a relative low level of 1.78 %.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof

The clearest trend in 2016 was the large increase in the use of fish for research. But almost the whole increase was due to introduction of a new species and a new field of research in the statistics. There is a very strong research community in Denmark concerning breeding eel for human consumption.

Until now it has not been possible to breed eel, which could survive beyond the larvae stadium. However due to scientific breakthroughs, it has recently changed, and the bread eel larvae now develop into fish covered by the directive. This covers a number of 23.935 animals, accounting for almost the whole increase in the use of fish. Procedures also covered by the directive are then performed on the animals, making them part of the statistic.

As this is a very important and economical interesting area, the numbers of eel in research are suspected to rise in the coming years. As this area is considered to be basic research, the increase in eel will affect the ratio.

In regard to the decrease in the numbers of rats and mice, the overall assessment is, that a stronger competition on research grands and stronger financially focus on the universities have made an impact on the number of research project using animals.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The number of animals experiencing severe severity has doubled in 2016 from 0,89 % to 1,75 %. The main reason is that two large research groups have had specific new focus on models with the highest severity. As Denmark generally has few animals experiencing severe severity, a new focus from just one or two research groups will affect the numbers dramatically. However the level of severe severity in Denmark is still relatively low.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Also in 2016, the Danish 3R-center has worked hard to promote the 3R´s, including funding research. Further information can be found on www.3rcenter.dk .

The national committee has also supported the animal welfare bodies, which are working more and more effectively. Yearly meetings, platforms for charring best practise, dissemination of 3R-tools and guidelines are some of the tolls used in 2016. Further information can be found on: https://www.foedevarestyrelsen.dk/english/Animal/AnimalWelfare/The_National_Committee_for_the_Protection_of_Animals_used_for_Scientific_Purposes/Pages/default.aspx

The Danish Animal Experiments Inspectorate hosts 3 annual mini-symposium for both scientific staff and for animal caretakers, discussing best practise and new models, as well as dissemination information on the legislation and correct statistical reporting.

It is difficult to investigate whether these efforts has a directly impact on the use of animals for research. However the decrease in the numbers of traditional animals as mice and rats will be followed to see, if some of this decrease has been influenced by the 3R initiatives.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The use of “other” categories has been used on an acceptable level in 2016.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No cases of animal experiencing the severe clarification exceeded was recorded in 2016 in Denmark.

Denmark: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

169970

58.77%

Rats

47575

16.45%

Guinea-Pigs

3362

1.16%

Hamsters (Syrian)

152

0.05%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

4

0%

Rabbits

2370

0.82%

Cats

18

0.01%

Dogs

266

0.09%

Ferrets

2

0%

Other carnivores

627

0.22%

Horses, donkeys and cross-breeds

328

0.11%

Pigs

8066

2.79%

Goats

6

0%

Sheep

37

0.01%

Cattle

2077

0.72%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

55

0.02%

Domestic fowl

1732

0.6%

Other birds

373

0.13%

Reptiles

220

0.08%

Rana

Xenopus

56

0.02%

Other Amphibians

30

0.01%

Zebra fish

3308

1.14%

Other Fish

48591

16.8%

Cephalopods

Total

289225

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

236103

83.01%

Animals born in the EU but not at a registered breeder

40201

14.13%

Animals born in rest of Europe

684

0.24%

Animals born in rest of world

7456

2.62%

Total

284444

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

104787

36.23%

Translational and applied research

153016

52.91%

Regulatory use and Routine production

21532

7.44%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

2792

0.97%

Preservation of species

1491

0.52%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

5547

1.92%

Forensic enquiries

60

0.02%

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

289225

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

6312

6.02%

Cardiovascular Blood and Lymphatic System

4789

4.57%

Nervous System

17706

16.9%

Respiratory System

1601

1.53%

Gastrointestinal System including Liver

4618

4.41%

Musculoskeletal System

2723

2.6%

Immune System

19079

18.21%

Urogenital/Reproductive System

1538

1.47%

Sensory Organs (skin, eyes and ears)

876

0.84%

Endocrine System/Metabolism

13964

13.33%

Multisystemic

949

0.91%

Ethology / Animal Behaviour /Animal Biology

25748

24.57%

Other basic research

4884

4.66%

Total

104787

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

27113

17.72%

Human Infectious Disorders

6632

4.33%

Human Cardiovascular Disorders

1786

1.17%

Human Nervous and Mental Disorders

34826

22.76%

Human Respiratory Disorders

137

0.09%

Human Gastrointestinal Disorders including Liver

139

0.09%

Human Musculoskeletal Disorders

401

0.26%

Human Immune Disorders

7015

4.58%

Human Urogenital/Reproductive Disorders

641

0.42%

Human Sensory Organ Disorders (skin, eyes and ears)

455

0.3%

Human Endocrine/Metabolism Disorders

40930

26.75%

Other Human Disorders

9135

5.97%

Animal Diseases and Disorders

19732

12.9%

Animal Welfare

2524

1.65%

Diagnosis of diseases

884

0.58%

Plant diseases

Non-regulatory toxicology and ecotoxicology

666

0.44%

Total

153016

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

8833

41.02%

Other efficacy and tolerance testing

113

0.52%

Toxicity and other safety testing including pharmacology

12586

58.45%

Routine production

Total

21532

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

3295

37.3%

Pyrogenicity testing

Batch potency testing

5486

62.11%

Other quality controls

52

0.59%

Total

8833

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

5366

42.63%

Skin irritation/corrosion

35

0.28%

Skin sensitisation

80

0.64%

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Target animal safety

Repeated dose toxicity

1701

13.52%

Kinetics

267

2.12%

Pharmaco-dynamics (incl safety pharmacology)

609

4.84%

Ecotoxicity

4528

35.98%

Total

12586

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

5366

100%

Other lethal methods

Non lethal methods

Total

5366

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

862

50.68%

29 - 90 days

229

13.46%

> 90 days

610

35.86%

Total

1701

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

3030

66.92%

Reproductive ecotoxicity

Endocrine activity

1440

31.8%

Bioaccumulation

58

1.28%

Other ecotoxicity

Total

4528

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

17000

78.95%

Legislation on medicinal products for veterinary use and their residues

4

0.02%

Medical devices legislation

Industrial chemicals legislation

2458

11.42%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

2070

9.61%

Total

21532

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

19398

90.09%

Legislation satisfying national requirements only [within EU]

2134

9.91%

Legislation satisfying Non-EU requirements only

Total

21532

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

284444

98.35%

Yes

4781

1.65%

Total

289225

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

22852

7.9%

Mild [up to and including]

181393

62.72%

Moderate

80451

27.82%

Severe

4529

1.57%

Total

289225

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

287229

99.31%

Yes

1996

0.69%

Total

289225

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

247082

85.43%

Genetically altered without a harmful phenotype

28548

9.87%

Genetically altered with a harmful phenotype

13595

4.7%

Total

289225

100.00%



Denmark: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period

The overall number of animals used for scientific purposes in Denmark in 2017 is 236,100. This is a significant decrease since 2016, where the number was 273,224 animals. But the total decrease is covered by the large drop in the number of fish – from 51,899 in 2016 to 17,125 in 2017. Taking this in account, the number of animals used in Denmark has been relatively stable over the last years

As usually, mice, rats and fish covers more than 90 % of the animals. The number of mice and rats has remained stable for several years (202,035 in 2015, 201,973 in 2016 and 201,621 in 2017).

The percentage of animals used for basic research is fallen from 38 % to 35 % reflecting the drop in fish (eel) used for this purpose.

Animals used for regulatory purposes and for routine production continues to be 8 %, confirming the relatively low number of animals used for that purpose in Denmark.

Finally the number of animals experiencing severe suffering has fallen in 2017 to a level of 0.74 %. This is confirming the trend that the percentage of severe suffering is varying around 1 %.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof

The clearest trend in 2017 was the large decrease in the use of fish for research. But as the large increase in 2016 was due to introduction of a new field of research in eel in the statistics, the large decrease is due to a change in research focus concerning the same animals.

Even though the total number of mice and rats is relatively stable, the number of mice has increased from 153,748 to 163,666 and the number of rats has decreased from 45,951 to 37,955. Some establishments traditionally using rats have been restructuring their laboratories in 2017, probably explaining the decrease in numbers. There is no obvious reason for the rice in the use of mice, but in a small country a strengthened focuses from a few research groups can have a large impact on the statistics. A rising use of GA animals could affect the number of mice, but the use of GA animals has not changed significantly from 2016 to 2017.

Finally the use of 3,680 cattle in 2017 is remarkable, as the number in 2016 was as low as 419 animals. However this is due to a few large “on farm” studies on cattle. The number probably will return to a much lower level in 2018.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The number of animals experiencing severe severity has fallen from 1,68 % in 2016 to 0,74 % in 2017. As Denmark generally has few animals experiencing severe severity, a changed focus from just one or two research groups will affect the numbers dramatically. The level of severe severity in Denmark is consistently relatively low.

There has been an increase in the percentage of moderate severity from 29 % to 36 % and a corresponding drop in the percentage of mild severity from 61 % to 53 %. There is no apparent explanation for this change, but the numbers will be followed closely to identify any lasting change.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Also in 2017, the Danish 3R-center has worked hard to promote the 3R´s, including funding research. Further information can be found on www.3rcenter.dk .

The national committee has also supported the animal welfare bodies, which are working more and more effectively. Yearly meetings, platforms for charring best practise, dissemination of 3R-tools and guidelines are some of the tolls used in 2017. Further information can be found on: https://www.foedevarestyrelsen.dk/english/Animal/AnimalWelfare/The_National_Committee_for_the_Protection_of_Animals_used_for_Scientific_Purposes/Pages/default.aspx

The Danish Animal Experiments Inspectorate hosts 3 annual mini-symposiums for both scientific staff and for animal caretakers, discussing best practise and new models, as well as dissemination information on the legislation and correct statistical reporting.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In two cases the use of “other” is relatively high in Denmark – in other carnivores and other fish. The carnivores represent a strong focus on research in mink for farming and concerning fish, Denmark has a large focus on research on rainbow trout for farming, as well as a continuing focus on eel research.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No cases of animal experiencing the severe clarification exceeded were recorded in 2017 in Denmark.

Denmark: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

164137

68.98%

Rats

38498

16.18%

Guinea-Pigs

2947

1.24%

Hamsters (Syrian)

282

0.12%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

3

0%

Rabbits

2443

1.03%

Cats

Dogs

214

0.09%

Ferrets

4

0%

Other carnivores

1035

0.43%

Horses, donkeys and cross-breeds

119

0.05%

Pigs

5803

2.44%

Goats

1

0%

Sheep

66

0.03%

Cattle

3677

1.55%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

28

0.01%

Domestic fowl

466

0.2%

Other birds

408

0.17%

Reptiles

289

0.12%

Rana

4

0%

Xenopus

285

0.12%

Other Amphibians

47

0.02%

Zebra fish

1587

0.67%

Other Fish

15606

6.56%

Cephalopods

Total

237949

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

205163

87.11%

Animals born in the EU but not at a registered breeder

24582

10.44%

Animals born in rest of Europe

552

0.23%

Animals born in rest of world

5215

2.21%

Total

235512

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

82918

34.85%

Translational and applied research

122146

51.33%

Regulatory use and Routine production

19865

8.35%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

2875

1.21%

Preservation of species

5637

2.37%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

4463

1.88%

Forensic enquiries

16

0.01%

Maintenance of colonies of established genetically altered animals, not used in other procedures

29

0.01%

Total

237949

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

6727

8.11%

Cardiovascular Blood and Lymphatic System

4270

5.15%

Nervous System

18241

22%

Respiratory System

2444

2.95%

Gastrointestinal System including Liver

2478

2.99%

Musculoskeletal System

3280

3.96%

Immune System

22727

27.41%

Urogenital/Reproductive System

2220

2.68%

Sensory Organs (skin, eyes and ears)

77

0.09%

Endocrine System/Metabolism

12632

15.23%

Multisystemic

485

0.58%

Ethology / Animal Behaviour /Animal Biology

2454

2.96%

Other basic research

4883

5.89%

Total

82918

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

18429

15.09%

Human Infectious Disorders

7665

6.28%

Human Cardiovascular Disorders

2016

1.65%

Human Nervous and Mental Disorders

31509

25.8%

Human Respiratory Disorders

176

0.14%

Human Gastrointestinal Disorders including Liver

762

0.62%

Human Musculoskeletal Disorders

378

0.31%

Human Immune Disorders

4959

4.06%

Human Urogenital/Reproductive Disorders

647

0.53%

Human Sensory Organ Disorders (skin, eyes and ears)

336

0.28%

Human Endocrine/Metabolism Disorders

37015

30.3%

Other Human Disorders

9168

7.51%

Animal Diseases and Disorders

5708

4.67%

Animal Welfare

1568

1.28%

Diagnosis of diseases

1023

0.84%

Plant diseases

Non-regulatory toxicology and ecotoxicology

787

0.64%

Total

122146

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

8139

40.97%

Other efficacy and tolerance testing

725

3.65%

Toxicity and other safety testing including pharmacology

10257

51.63%

Routine production

744

3.75%

Total

19865

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

2504

30.77%

Pyrogenicity testing

Batch potency testing

5601

68.82%

Other quality controls

34

0.42%

Total

8139

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

3968

38.69%

Skin irritation/corrosion

28

0.27%

Skin sensitisation

177

1.73%

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Safety testing in food and feed area

Target animal safety

Repeated dose toxicity

2205

21.5%

Reproductive toxicity

935

9.12%

Kinetics

818

7.98%

Pharmaco-dynamics (incl safety pharmacology)

26

0.25%

Ecotoxicity

2100

20.47%

Total

10257

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

3968

100%

Other lethal methods

Non lethal methods

Total

3968

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

1382

62.68%

29 - 90 days

586

26.58%

> 90 days

237

10.75%

Total

2205

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

120

5.71%

Chronic toxicity

1800

85.71%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

180

8.57%

Other ecotoxicity

Total

2100

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

288

38.71%

Monoclonal antibody by mouse ascites method

Other product types

456

61.29%

Total

744

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

16634

83.74%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

2987

15.04%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

244

1.23%

Total

19865

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

19765

99.5%

Legislation satisfying national requirements only [within EU]

100

0.5%

Legislation satisfying Non-EU requirements only

Total

19865

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

235512

98.98%

Yes

2437

1.02%

Total

237949

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

22871

9.61%

Mild [up to and including]

127013

53.38%

Moderate

86303

36.27%

Severe

1762

0.74%

Total

237949

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

234261

98.45%

Yes

3688

1.55%

Total

237949

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

198043

83.23%

Genetically altered without a harmful phenotype

27907

11.73%

Genetically altered with a harmful phenotype

11999

5.04%

Total

237949

100.00%



Estonia

Estonia: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

No significant trends are observed in 2015 compared to 2014. The number of companies dealing with experimental animals is the same. No new authorisations were given to small companies which do not have separate AWB at the place. Experiments done in such small companies are with small number of animals. All new licences were given to companies with own animal welfare body at establishment, therefore the quality of animal experiments has increased.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2014 Estonia reported that 50.55% of the animals used were used for basic research purpose. In 2015 the percentage for basic research was 83.53. In 2014 47.70% of animals were used for translational and applied research, in 2015 this percentage was 14.28. In 2014 8.28% of animals were used for legislation satisfying EU requirements, in 2015 this percentage was 38.53. In 2014 24.05% of animals were used for human cancer research, in 2015 this percentage was 85.38. These were the biggest changes in the number of animals used in certain categories. Main reason for such changes is finance. Human cancer, legislation satisfying EU requirements and translational and applied research projects got grants in 2015.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2014 13.16% of animals were classified as non-recovery, in 2015 this percentage was 7.01. In 2014 1.87% of animals were classified as severe, in 2015 this percentage was 8.02. As Estonia only gave 26 licences in 2015 these changes are not significant. The usage of animals mostly depends on finance (what grants are received). All projects are evaluated by PAC members.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

We have continued the process of carefully evaluating each application. The members of PAC include and expert of anaesthesia, expert of statistics, expert of pharmacology etc. Such experts make sure that optimal number of animals is used in each project and no projects are duplicated.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

All fish classified as other fish were roaches. All birds classified as other birds were common gulls.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

PAC has not given licences exceeding severe classification.

Estonia: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

2965

76.99%

Rats

123

3.19%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

6

0.16%

Goats

Sheep

Cattle

283

7.35%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

294

7.63%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

180

4.67%

Cephalopods

Total

3851

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2920

78.2%

Animals born in the EU but not at a registered breeder

736

19.71%

Animals born in rest of Europe

78

2.09%

Animals born in rest of world

Total

3734

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

3190

82.84%

Translational and applied research

570

14.8%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

83

2.16%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

8

0.21%

Total

3851

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

1338

41.94%

Cardiovascular Blood and Lymphatic System

12

0.38%

Nervous System

274

8.59%

Respiratory System

Gastrointestinal System including Liver

78

2.45%

Musculoskeletal System

Immune System

435

13.64%

Urogenital/Reproductive System

60

1.88%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

213

6.68%

Multisystemic

50

1.57%

Ethology / Animal Behaviour /Animal Biology

215

6.74%

Other basic research

515

16.14%

Total

3190

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

483

84.74%

Human Infectious Disorders

Human Cardiovascular Disorders

87

15.26%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

570

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

3734

96.96%

Yes

117

3.04%

Total

3851

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

284

7.37%

Mild [up to and including]

1552

40.3%

Moderate

1681

43.65%

Severe

334

8.67%

Total

3851

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

3851

100%

Yes

Total

3851

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

3397

88.21%

Genetically altered without a harmful phenotype

454

11.79%

Genetically altered with a harmful phenotype

Total

3851

100.00%



Estonia: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

No significant trends are observed in 2016 compared to 2015. One new authorisation was given to a company dealing with experimental animals, however they did not apply for a licence in 2016. All new licences were given to companies with own animal welfare body at establishment, therefore the quality of animal experiments has increased.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2015 2376 mice, 51 rats, 6 pigs, 566 cattle, 294 other birds, 180 other fish were used for basic research. In 2016 3079 mice, 90 rats, 252 other birds and 32 other fish were used for basic research. In 2015 550 mice and 45 rats were used for translational and applied research, in 2016 31 mice and no rats were used for that purpose. In 2015 56 mice and 27 rats were used for higher education purposes, however no animals were used for that purpose in 2016. In 2015 16 mice were used for the purpose of maintaining colonies, in 2016 the number of mice used for that purpose was 242. It can be said that the main difference between the years was that the number of animal used for maintaining colonies significantly increased and compared to 2015, in 2016 no animals were used for higher education purpose. Also, no cattle or other animal species were used in 2016 compared to 2015.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2015 44.04% of animals used were classified as mild, in 2016 this percentage was 37.44. In 2015, 40.94% of animals used were classified as moderate, in 2016 this percentage was 48.85. In 2015, 8.02% of animals were severely used, in 2016 this percentage was 10.82. In 2015, 7.01% of animals were classified as non- recovery. In 2016 this percentage was 2.90. There are no major changes in actual severities when comparing the two years.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

We have continued the process of carefully evaluating each application. The members of PAC include and expert of anaesthesia, expert of statistics, expert of pharmacology etc. Such experts make sure that optimal number of animals is used in each project and no projects are duplicated.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

All birds classified as other birds were great tits (Parus major). All fish classified as other fish were round gobies (Neogobius melanostomus).

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

PAC has not given licences exceeding severe classification.

Estonia: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

3193

89.51%

Rats

90

2.52%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

252

7.06%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

32

0.9%

Cephalopods

Total

3567

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

3176

91.79%

Animals born in the EU but not at a registered breeder

284

8.21%

Animals born in rest of Europe

Animals born in rest of world

Total

3460

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

3294

92.35%

Translational and applied research

31

0.87%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

242

6.78%

Total

3567

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

1638

49.73%

Cardiovascular Blood and Lymphatic System

12

0.36%

Nervous System

546

16.58%

Respiratory System

Gastrointestinal System including Liver

140

4.25%

Musculoskeletal System

75

2.28%

Immune System

20

0.61%

Urogenital/Reproductive System

30

0.91%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

549

16.67%

Multisystemic

Ethology / Animal Behaviour /Animal Biology

284

8.62%

Other basic research

Total

3294

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

31

100%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

31

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

3460

97%

Yes

107

3%

Total

3567

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

108

3.03%

Mild [up to and including]

1395

39.11%

Moderate

1724

48.33%

Severe

340

9.53%

Total

3567

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

3351

93.94%

Yes

216

6.06%

Total

3567

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

2668

74.8%

Genetically altered without a harmful phenotype

899

25.2%

Genetically altered with a harmful phenotype

Total

3567

100.00%

Estonia: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

Compared to 2016 some changes in trends were observed. Number of animals used dropped another 12% (decrease in 2015 vs 2016 was 10%). This year there we none in re-use (in 2016 3% from all uses). Creation of new GL dropped again, from 6,06% to 2,8% (none in 2015). Like in 2015 and 2016 no harmful GA lines were used in 2017. The GA animals used are thoroughly researched and known to have no harmful qualities. About 2/3 of the animals used are not genetically altered. This number has dropped from last year where about ¾ were not altered since more projects use GA animals. Insignificant changes in severities - non-recovery and mild have mildly increased, moderate and severe decreased. Changes in species – less mice, more rats were used; quantity of birds decreased as well; no fish were used but in 2017 again 16 cattle and 4 pigs were used (no projects in 2016). More animals came from an EU registered breeder (94,28% vs 91,79%).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Number of uses in translational and applied research rose from 0,87% to 6,68%. Human respiratory disorders were investigated with 210 uses. There were no projects of higher education or training for the acquisition, maintenance or improvement of vocational skills in 2016 but now in 2017 it took 1,21% of all uses. There were no competence courses in laboratory animal science in Estonia that year. Maintenance of colonies rose from 6,78% to 12,52% since laboratories are using more GA lines. No regulatory use in 2016 but 112 in 2017 – legislation on medicinal products for human use (from that 38 uses for carcinogenicity and 74 for genotoxicity). Oncology still is the most important research area, where 41% of the work is done. More uses than last year had cardiovascular, sensory, multisystemic, immune and nervous system.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2016 39% of animals used were classified as mild, in 2017 this percentage was 44. In 2016, 48% of animals used were classified as moderate, in 2017 this percentage was 43. In 2016, 9,5% of animals were severely used, in 2017 this percentage was 8,7. In 2016, 3% of animals were classified as non- recovery. In 2017 this percentage was 4. There are no major changes in actual severities when comparing the two years. The proportion of moderate is higher than the average EU and might come from the facts that the committee is strict and that more harsh projects are done.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

We have continued the process of carefully evaluating each application. The members of PAC include and expert of anaesthesia, expert of statistics, expert of pharmacology etc. Such experts make sure that optimal number of animals is used in each project and no projects are duplicated.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

From the birds that were classified as other birds 115 were common gulls and 65 were great tits. Proportion of birds 5,72% of all animals.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

PAC has not given licences exceeding severe classification.

Estonia: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

2578

81.95%

Rats

368

11.7%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

4

0.13%

Goats

Sheep

Cattle

16

0.51%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

180

5.72%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

3146

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2966

94.28%

Animals born in the EU but not at a registered breeder

180

5.72%

Animals born in rest of Europe

Animals born in rest of world

Total

3146

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

2392

76.03%

Translational and applied research

210

6.68%

Regulatory use and Routine production

112

3.56%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

38

1.21%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

394

12.52%

Total

3146

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

985

41.18%

Cardiovascular Blood and Lymphatic System

93

3.89%

Nervous System

495

20.69%

Respiratory System

Gastrointestinal System including Liver

32

1.34%

Musculoskeletal System

88

3.68%

Immune System

99

4.14%

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

32

1.34%

Endocrine System/Metabolism

219

9.16%

Multisystemic

153

6.4%

Ethology / Animal Behaviour /Animal Biology

180

7.53%

Other basic research

16

0.67%

Total

2392

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

210

100%

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

210

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

112

100%

Total

112

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total



Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

38

33.93%

Carcinogenicity

74

66.07%

Total

112

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

38

100%

29 - 90 days

> 90 days

Total

38

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

112

100%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

112

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

112

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

112

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

3146

100%

Yes

Total

3146

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

132

4.2%

Mild [up to and including]

1385

44.02%

Moderate

1354

43.04%

Severe

275

8.74%

Total

3146

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

3058

97.2%

Yes

88

2.8%

Total

3146

100.00%



Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1956

62.17%

Genetically altered without a harmful phenotype

1190

37.83%

Genetically altered with a harmful phenotype

Total

3146

100.00%



Finland

Finland: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

In 2015, a total of 96 817 procedures in animals were done in Finland, which was 33 % less than 2014 (145 542 procedures in 2014). The greatest reductions were in the procedures with fish (other than zebra fish 38 483). The change was due to the ending of one project with large fish use. The use of mice in procedures decreased also (10 941). This may however be explained with the more precise reporting. The reductions in use of both species were mainly in basic research. The use of rats increased by 1679 rats in translational and applied research.

28 % of animals used were genetically altered (mice, rats and zebra fish). 7 % of them had a harmful phenotype.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The number of procedures done in basic research were 62 223 procedures - main areas being nervous system, immune system, multisystemic and ethology/animal behavior/animal biology. For the translational and applied research (25 634 procedures) the main category of purposes were human nervous and mental disorders (15 878 procedures).

Dogs reported as used in procedures (2619) included 2326 pet dogs which gave a blood sample for a study of disease genes and 196 pet dogs which participated in patient studies for better treatment methods. Dogs bred and used in laboratories were used in 97 procedures including 71 re-use. Cats reported as used in procedures (100) were all pet cats with blood sampling for a study of disease genes.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Actual severities of procedures: 60 % of the procedures were classified as non-recovery or mild, 34 % moderate and 6 % severe. By species, the severe procedures involved 2934 mice (5199 mice in 2014) and 2679 rats (1960 rats in 2014). Most of the severe procedures (4008) were done in category of human nervous and mental disorders.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Funding of Finnish Centre for Alternative Methods (FICAM) for development of alternative methods and training courses.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

-

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The severe classification was not exceeded in any procedures.

Finland: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

50047

51.69%

Rats

15976

16.5%

Guinea-Pigs

50

0.05%

Hamsters (Syrian)

197

0.2%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

213

0.22%

Cats

100

0.1%

Dogs

2619

2.71%

Ferrets

Other carnivores

270

0.28%

Horses, donkeys and cross-breeds

48

0.05%

Pigs

479

0.49%

Goats

Sheep

1128

1.17%

Cattle

87

0.09%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

2880

2.97%

Domestic fowl

3646

3.77%

Other birds

717

0.74%

Reptiles

Rana

10

0.01%

Xenopus

Other Amphibians

Zebra fish

10821

11.18%

Other Fish

7529

7.78%

Cephalopods

Total

96817

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

76799

79.95%

Animals born in the EU but not at a registered breeder

18207

18.95%

Animals born in rest of Europe

7

0.01%

Animals born in rest of world

1042

1.08%

Total

96055

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

62223

64.27%

Translational and applied research

25634

26.48%

Regulatory use and Routine production

5364

5.54%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

1455

1.5%

Preservation of species

41

0.04%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1170

1.21%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

930

0.96%

Total

96817

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

7529

12.1%

Cardiovascular Blood and Lymphatic System

5253

8.44%

Nervous System

14531

23.35%

Respiratory System

Gastrointestinal System including Liver

558

0.9%

Musculoskeletal System

701

1.13%

Immune System

10115

16.26%

Urogenital/Reproductive System

500

0.8%

Sensory Organs (skin, eyes and ears)

1223

1.97%

Endocrine System/Metabolism

4000

6.43%

Multisystemic

8112

13.04%

Ethology / Animal Behaviour /Animal Biology

9425

15.15%

Other basic research

276

0.44%

Total

62223

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

2375

9.27%

Human Infectious Disorders

Human Cardiovascular Disorders

604

2.36%

Human Nervous and Mental Disorders

15878

61.94%

Human Respiratory Disorders

62

0.24%

Human Gastrointestinal Disorders including Liver

24

0.09%

Human Musculoskeletal Disorders

16

0.06%

Human Immune Disorders

24

0.09%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

1237

4.83%

Human Endocrine/Metabolism Disorders

85

0.33%

Other Human Disorders

23

0.09%

Animal Diseases and Disorders

4593

17.92%

Animal Welfare

444

1.73%

Diagnosis of diseases

127

0.5%

Plant diseases

Non-regulatory toxicology and ecotoxicology

142

0.55%

Total

25634

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1576

29.38%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

2538

47.32%

Routine production

1250

23.3%

Total

5364

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

Other quality controls

Pyrogenicity testing

Batch potency testing

1576

100%

Total

1576

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

50

1.97%

Skin irritation/corrosion

10

0.39%

Skin sensitisation

40

1.58%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Target animal safety

Repeated dose toxicity

94

3.7%

Kinetics

590

23.25%

Pharmaco-dynamics (incl safety pharmacology)

1754

69.11%

Total

2538

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

50

100%

Total

50

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

94

100%

29 - 90 days

> 90 days

Total

94

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

1250

100%

Total

1250

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

3708

69.13%

Legislation on medicinal products for veterinary use and their residues

1656

30.87%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

5364

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

5364

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

5364

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

96055

99.21%

Yes

762

0.79%

Total

96817

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

4977

5.14%

Mild [up to and including]

53408

55.16%

Moderate

32819

33.9%

Severe

5613

5.8%

Total

96817

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

87608

90.49%

Yes

9209

9.51%

Total

96817

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

69334

71.61%

Genetically altered without a harmful phenotype

22004

22.73%

Genetically altered with a harmful phenotype

5479

5.66%

Total

96817

100.00%

Finland: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

In 2016, a total of 105 615 procedures in animals were done in Finland, which was 9 % more than in 2015 (96 817 procedures). The greatest increases were in the procedures with mice (7 792 animals more), other rodents (1364 more) and domestic fowls (4 765 more).

45 % of mice used were genetically altered and 13 % (7328 mice) had a harmful phenotype. With rats, 3 % were genetically altered, one rat with harmful phenotype. With zebrafish, the numbers were 58 % and 16 % (1206 zebra fish), respectively.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The number of procedures done in basic research were 55 744 procedures, main areas being Nervous system (14 320 procedures), Immune system, Multisystemic and Ethology/Animal behavior/Animal biology (8 795, 10 539 and 7 376, respectively). For the translational and applied research (40 591 procedures) the main categories of purposes were Human nervous and mental disorders (20 831 procedures) and Animal diseases and disorders (9 869 procedures). In regulatory use and routine production, 2 645 domestic fowls were used for quality control, 1 457 animals (sheep, pigs, domestic fowls and horses) for routine products and 2 916 animals (mice, rats, dogs, pigs) in toxicity and other safety testing.

The increased use of mice in procedures (16 %) took place in the translational and applied research in studies for Human nervous and mental disorders. Other rodents (bank voles: 1314 animals) were used in the basic research (Ethology/Animal behavior/Animal biology). The procedures in domestic fowls increased in the translational and applied research (Animal diseases and disorders) and in the regulatory use and routine production (Quality control).

Procedures reported as done in dogs (3961) included 3582 procedures in pet dogs which gave a blood sample for a study of disease genes. 244 procedures were done in pet dogs which participated in patient studies for better treatment methods. Dogs bred and used in laboratories were used in 135 procedures including 116 re-use. Cats reported as used in procedures (259) were all pet cats with blood sampling for a study of disease genes.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

61,5 % of the procedures were classified as non-recovery or mild, 30 % moderate and 8,5 % severe. By species, the severe procedures involved 6 862 mice (2934 in 2015) and 2161 rats (2 679 in 2015). The severe procedures in mice and rats were done mainly in the purpose of Human nervous and mental disorders both in basic and translational research. The significant increase or severe procedures with mice was due to single projects with high animal numbers.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Funding of Finnish Centre for Alternative Methods (FICAM) for development of alternative methods and training courses.

 5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

-

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The severe classification was not exceeded in any procedures.

Finland: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

57839

54.76%

Rats

15297

14.48%

Guinea-Pigs

10

0.01%

Hamsters (Syrian)

273

0.26%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

1364

1.29%

Rabbits

237

0.22%

Cats

259

0.25%

Dogs

3961

3.75%

Ferrets

Other carnivores

18

0.02%

Horses, donkeys and cross-breeds

76

0.07%

Pigs

611

0.58%

Goats

Sheep

1350

1.28%

Cattle

541

0.51%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

103

0.1%

Domestic fowl

8411

7.96%

Other birds

501

0.47%

Reptiles

Rana

2

0%

Xenopus

Other Amphibians

Zebra fish

7483

7.09%

Other Fish

7279

6.89%

Cephalopods

Total

105615

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

84134

80.23%

Animals born in the EU but not at a registered breeder

15053

14.35%

Animals born in rest of Europe

981

0.94%

Animals born in rest of world

4702

4.48%

Total

104870

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

55744

52.78%

Translational and applied research

40591

38.43%

Regulatory use and Routine production

7026

6.65%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

35

0.03%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1753

1.66%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

466

0.44%

Total

105615

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

4212

7.56%

Cardiovascular Blood and Lymphatic System

5187

9.31%

Nervous System

14320

25.69%

Respiratory System

258

0.46%

Gastrointestinal System including Liver

501

0.9%

Musculoskeletal System

562

1.01%

Immune System

8795

15.78%

Urogenital/Reproductive System

524

0.94%

Sensory Organs (skin, eyes and ears)

310

0.56%

Endocrine System/Metabolism

2614

4.69%

Multisystemic

10539

18.91%

Ethology / Animal Behaviour /Animal Biology

7376

13.23%

Other basic research

546

0.98%

Total

55744

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

3325

8.19%

Human Infectious Disorders

995

2.45%

Human Cardiovascular Disorders

676

1.67%

Human Nervous and Mental Disorders

20831

51.32%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

74

0.18%

Human Musculoskeletal Disorders

1204

2.97%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

2169

5.34%

Human Endocrine/Metabolism Disorders

386

0.95%

Other Human Disorders

586

1.44%

Animal Diseases and Disorders

9869

24.31%

Animal Welfare

199

0.49%

Diagnosis of diseases

89

0.22%

Plant diseases

Non-regulatory toxicology and ecotoxicology

188

0.46%

Total

40591

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

2645

37.65%

Other efficacy and tolerance testing

8

0.11%

Toxicity and other safety testing including pharmacology

2916

41.5%

Routine production

1457

20.74%

Total

7026

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

Other quality controls

Pyrogenicity testing

Batch potency testing

2645

100%

Total

2645

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

49

1.68%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

196

6.72%

Kinetics

850

29.15%

Pharmaco-dynamics (incl safety pharmacology)

1821

62.45%

Total

2916

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

9

18.37%

Other lethal methods

Non lethal methods

40

81.63%

Total

49

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

100

51.02%

29 - 90 days

> 90 days

96

48.98%

Total

196

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

317

21.76%

Monoclonal antibody by mouse ascites method

Other product types

1140

78.24%

Total

1457

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

4332

61.66%

Legislation on medicinal products for veterinary use and their residues

2694

38.34%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

7026

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

6709

95.49%

Legislation satisfying national requirements only [within EU]

317

4.51%

Legislation satisfying Non-EU requirements only

Total

7026

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

104870

99.29%

Yes

745

0.71%

Total

105615

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

9198

8.71%

Mild [up to and including]

55602

52.65%

Moderate

31797

30.11%

Severe

9018

8.54%

Total

105615

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

101359

95.97%

Yes

4256

4.03%

Total

105615

100.00%



Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

74960

70.97%

Genetically altered without a harmful phenotype

22120

20.94%

Genetically altered with a harmful phenotype

8535

8.08%

Total

105615

100.00%



Finland: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In 2017, a total of 102 575 procedures in animals were done in Finland, which was 3 % less than in 2016 (105 615 procedures). The greatest decreases were in the procedures with mice (4 838 animals less) mainly in basic research and rats (1 825 less) in translational and applied research. The number of procedures with other fish increased (4 450 more).

48 % of mice used were genetically altered and 17 % (8817 mice) had a harmful phenotype. With rats, 4 % were genetically altered, all without a harmful phenotype. With zebrafish, 51 % of the used fish were genetically altered, all without a harmful phenotype.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The number of procedures done in basic research were 59 278 procedures, main areas being Nervous system (11 905 procedures, decreased) and Immune system (11 024 procedures, increased). Other areas of basic research were Multisystemic (7 587, decreased), Ethology/Animal Behavior/Animal Biology (7 546, no change), Oncology (6 791, increased) and Cardiovascular Blood and Lymphatic Systems (5 145, no change).

For the translational and applied research (33 521 procedures) the main categories of purposes were Human nervous and mental disorders (19 703 procedures, decreased), Human Cancer (5 016, increased) and Animal diseases and disorders (4 384 procedures, decreased).

In Regulatory use and Routine production, 3 395 domestic fowls were used for Quality control and 1 476 animals (sheep, pigs, domestic fowls and horses) for Routine products. For Toxicity and other safety testing, 2 868 animals (mice, rats, dogs, pigs, rabbits) were used mainly for Kinetics and Pharmaco-dynamics.

Procedures reported as done in dogs (3 061) included 2 840 procedures in pet dogs which gave a blood sample for a study of disease genes. 195 procedures were done in pet dogs which participated in patient studies for better treatment methods. Dogs bred and used in laboratories were used in 26 procedures including 26 re-use. Cats reported as used in procedures (311) were all pet cats with blood sampling for a study of disease genes.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Actual severities of procedures: 8,9 % of the procedures were classified as non-recovery, 48,5 % mild, 34,1 % moderate and 8,5 % severe. By species, the severe procedures involved 7 125 mice (6 862 in 2016) and 1 568 rats (2 161 in 2016). There were changes in the numbers of procedures with mild or moderate severity without clear reasons for them. As in previous years, the severe procedures were done mainly in the purpose of Human nervous and mental disorders in translational research (6 722 procedures).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Funding of Finnish Centre for Alternative Methods (FICAM) for development of alternative methods and training courses.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

-

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The severe classification was not exceeded in any procedures.

Finland: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

53001

51.67%

Rats

13472

13.13%

Guinea-Pigs

9

0.01%

Hamsters (Syrian)

149

0.15%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

690

0.67%

Rabbits

227

0.22%

Cats

311

0.3%

Dogs

3061

2.98%

Ferrets

Other carnivores

107

0.1%

Horses, donkeys and cross-breeds

77

0.08%

Pigs

632

0.62%

Goats

Sheep

1319

1.29%

Cattle

216

0.21%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1533

1.49%

Domestic fowl

8485

8.27%

Other birds

404

0.39%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

7153

6.97%

Other Fish

11729

11.43%

Cephalopods

Total

102575

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

76287

74.48%

Animals born in the EU but not at a registered breeder

23562

23%

Animals born in rest of Europe

5

0%

Animals born in rest of world

2572

2.51%

Total

102426

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

59278

57.79%

Translational and applied research

33521

32.68%

Regulatory use and Routine production

7895

7.7%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

60

0.06%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1606

1.57%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

215

0.21%

Total

102575

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

6791

11.46%

Cardiovascular Blood and Lymphatic System

5145

8.68%

Nervous System

11905

20.08%

Respiratory System

80

0.13%

Gastrointestinal System including Liver

545

0.92%

Musculoskeletal System

337

0.57%

Immune System

11024

18.6%

Urogenital/Reproductive System

181

0.31%

Sensory Organs (skin, eyes and ears)

268

0.45%

Endocrine System/Metabolism

1387

2.34%

Multisystemic

7587

12.8%

Ethology / Animal Behaviour /Animal Biology

7546

12.73%

Other basic research

6482

10.93%

Total

59278

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

5016

14.96%

Human Infectious Disorders

860

2.57%

Human Cardiovascular Disorders

662

1.97%

Human Nervous and Mental Disorders

19703

58.78%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

117

0.35%

Human Musculoskeletal Disorders

605

1.8%

Human Immune Disorders

71

0.21%

Human Urogenital/Reproductive Disorders

8

0.02%

Human Sensory Organ Disorders (skin, eyes and ears)

477

1.42%

Human Endocrine/Metabolism Disorders

442

1.32%

Other Human Disorders

759

2.26%

Animal Diseases and Disorders

4384

13.08%

Animal Welfare

226

0.67%

Diagnosis of diseases

123

0.37%

Plant diseases

Non-regulatory toxicology and ecotoxicology

68

0.2%

Total

33521

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

3395

43%

Other efficacy and tolerance testing

156

1.98%

Toxicity and other safety testing including pharmacology

2868

36.33%

Routine production

1476

18.7%

Total

7895

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

Other quality controls

Pyrogenicity testing

Batch potency testing

3395

100%

Total

3395

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

134

4.67%

Kinetics

1171

40.83%

Pharmaco-dynamics (incl safety pharmacology)

1556

54.25%

Other toxicity/safety testing

7

0.24%

Total

2868

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

134

100%

29 - 90 days

> 90 days

Total

134

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

296

20.05%

Monoclonal antibody by mouse ascites method

Other product types

1180

79.95%

Total

1476

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

4468

56.59%

Legislation on medicinal products for veterinary use and their residues

3395

43%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

32

0.41%

Cosmetics legislation

Other legislation

Total

7895

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

7599

96.25%

Legislation satisfying national requirements only [within EU]

296

3.75%

Legislation satisfying Non-EU requirements only

Total

7895

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

102426

99.85%

Yes

149

0.15%

Total

102575

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

9082

8.85%

Mild [up to and including]

49770

48.52%

Moderate

34984

34.11%

Severe

8739

8.52%

Total

102575

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

97716

95.26%

Yes

4859

4.74%

Total

102575

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

73080

71.25%

Genetically altered without a harmful phenotype

20678

20.16%

Genetically altered with a harmful phenotype

8817

8.6%

Total

102575

100.00%



France

France: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period (2014).

The transposition of Directive 2010/63/EU into French law has given rise to significant changes.

Indeed, the format prescribed by the European Union for the retrospective survey for 2015 under Directive 2010/63/EU, which was transposed into French law on 7 February 2013, is different from that used for the previous surveys under Directive 86/609/EU. Any comparison with the 2014 survey would therefore be inappropriate, particularly for the period 2013-2017, which was marked by transitional regulatory measures.

The scope of the survey has changed considerably:

-only animals for which the experimental procedures ended in 2015 are recorded;

-captive-bred animals present in user establishments are excluded;

-animals involved in procedures below the stress threshold, including genetically modified animal lines that do not exhibit a harmful phenotype, are excluded;

-animals humanely killed according to regulatory methods for the removal of organs or tissue (used for alternative methods) are excluded.

2. Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

As the conditions of the statistical survey have changed, its results are not directly comparable with the figures previously published (for 2014). Consequently, any comparative analysis that reached a conclusion regarding an increase or decrease in the number of animals used for scientific purposes would be inappropriate.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

As the conditions of the statistical survey have changed, its results are not directly comparable with the figures previously published (for 2014). Consequently, any comparative analysis of the changes in trends in actual severities would be inappropriate.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The principles of replacement, refinement and reduction have been part of the French policy on the use of animals for scientific purposes since the ten founding measures were introduced in 1992 by the Minister for Research, Hubert Curien. Teaching these principles is an essential part of training staff, whether they are responsible for caring for the animals or for carrying out and designing scientific projects. The work of the National Commission for Animal Testing and the National Ethical Reflection Committee on Animal Testing, which meet several times a year, is crucial in this respect. The transposition of Directive 2010/63/EU, which requires prior authorisation for any project using animals for scientific purposes, and the choice of the French authorities to draw on the expertise of nearly 130 ethical committees spread throughout France, has also encouraged researchers to think more about these three principles and helped increase the sharing of best practice.

5. Further breakdown on the use of “other” categories if a significant proportion of animal use is reported under this category.

Grouping species of the same taxon in the ‘other’ category, as proposed by the European Commission, does not always seem to be the most appropriate method and could be improved, in particular in the case of fish and birds.

For example, although zebra-fish account for just 0.6% of animals used (11,665 animals), ‘other fish’ account for 29.6% (524,024 animals). The latter category includes farmed fish such as trout, eel, seabass and salmon, the reproduction, physiology and diet of which are the subject of numerous studies, particularly by the National Institute for Agricultural Research (INRA).

Large numbers of birds are also categorised as ‘other’ (44,248 animals), while ‘domestic fowl’ account for 48,528.

Finally, with respect to the distribution of animals involved in procedures laid down in the rules, almost half are entered in the ‘other’ category, which suggests that the proposed headings are not the most appropriate, or have been misunderstood by users. Particular attention will be given to how this section is completed in the next survey.

6. Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.’

Procedures are classified into four categories: non-recovery, mild, moderate and severe (including intense/severe procedures). No instances of the ‘severe’ classification being exceeded have been identified.

France: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1007245

52.97%

Rats

157183

8.27%

Guinea-Pigs

44414

2.34%

Hamsters (Syrian)

10986

0.58%

Hamsters (Chinese)

Mongolian gerbil

1417

0.07%

Other Rodents

755

0.04%

Rabbits

108110

5.69%

Cats

336

0.02%

Dogs

3143

0.17%

Ferrets

155

0.01%

Other carnivores

30

0%

Horses, donkeys and cross-breeds

629

0.03%

Pigs

12203

0.64%

Goats

436

0.02%

Sheep

3446

0.18%

Cattle

2203

0.12%

Prosimians

157

0.01%

Marmoset and tamarins

97

0.01%

Cynomolgus monkey

2756

0.14%

Rhesus monkey

64

0%

Vervets (Chlorocebus spp.)

56

0%

Baboons

18

0%

Squirrel monkey

13

0%

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1772

0.09%

Domestic fowl

66734

3.51%

Other birds

46433

2.44%

Reptiles

1051

0.06%

Rana

306

0.02%

Xenopus

1644

0.09%

Other Amphibians

3167

0.17%

Zebra fish

11399

0.6%

Other Fish

413183

21.73%

Cephalopods

1

0%

Total

1901542

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1550643

82.26%

Animals born in the EU but not at a registered breeder

258592

13.72%

Animals born in rest of Europe

66947

3.55%

Animals born in rest of world

8893

0.47%

Total

1885075

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

128

6.92%

Animals born in rest of Europe

14

0.76%

Animals born in Asia

42

2.27%

Animals born in America

55

2.97%

Animals born in Africa

1521

82.17%

Animals born elsewhere

91

4.92%

Total

1851

100.00%



Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

1

0.05%

F1

1202

64.94%

F2 or greater

433

23.39%

Self-sustaining colony

215

11.62%

Total

1851

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

792453

41.67%

Translational and applied research

432557

22.75%

Regulatory use and Routine production

572144

30.09%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

1122

0.06%

Preservation of species

3380

0.18%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

28062

1.48%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

71824

3.78%

Total

1901542

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

63910

8.06%

Cardiovascular Blood and Lymphatic System

40007

5.05%

Nervous System

92332

11.65%

Respiratory System

11520

1.45%

Gastrointestinal System including Liver

63028

7.95%

Musculoskeletal System

9931

1.25%

Immune System

68167

8.6%

Urogenital/Reproductive System

26770

3.38%

Sensory Organs (skin, eyes and ears)

12399

1.56%

Endocrine System/Metabolism

26196

3.31%

Multisystemic

29703

3.75%

Ethology / Animal Behaviour /Animal Biology

345624

43.61%

Other basic research

2866

0.36%

Total

792453

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

126277

29.19%

Human Infectious Disorders

65335

15.1%

Human Cardiovascular Disorders

9735

2.25%

Human Nervous and Mental Disorders

61259

14.16%

Human Respiratory Disorders

3043

0.7%

Human Gastrointestinal Disorders including Liver

7405

1.71%

Human Musculoskeletal Disorders

12075

2.79%

Human Immune Disorders

11943

2.76%

Human Urogenital/Reproductive Disorders

2756

0.64%

Human Sensory Organ Disorders (skin, eyes and ears)

9717

2.25%

Human Endocrine/Metabolism Disorders

22966

5.31%

Other Human Disorders

1387

0.32%

Animal Diseases and Disorders

45194

10.45%

Animal Welfare

2656

0.61%

Diagnosis of diseases

31652

7.32%

Plant diseases

Non-regulatory toxicology and ecotoxicology

19157

4.43%

Total

432557

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

276166

48.27%

Other efficacy and tolerance testing

39738

6.95%

Toxicity and other safety testing including pharmacology

102867

17.98%

Routine production

153373

26.81%

Total

572144

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

62846

22.76%

Pyrogenicity testing

5981

2.17%

Batch potency testing

207339

75.08%

Other quality controls

Total

276166

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

7869

7.65%

Skin irritation/corrosion

1750

1.7%

Skin sensitisation

11491

11.17%

Eye irritation/corrosion

548

0.53%

Repeated dose toxicity

22904

22.27%

Carcinogenicity

1054

1.02%

Genotoxicity

854

0.83%

Reproductive toxicity

13109

12.74%

Developmental toxicity

8293

8.06%

Neurotoxicity

202

0.2%

Kinetics

8841

8.59%

Pharmaco-dynamics (incl safety pharmacology)

9119

8.86%

Phototoxicity

420

0.41%

Ecotoxicity

13360

12.99%

Safety testing in food and feed area

733

0.71%

Target animal safety

273

0.27%

Other toxicity/safety testing

2047

1.99%

Total

102867

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

2713

34.48%

Other lethal methods

1373

17.45%

Non lethal methods

3783

48.07%

Total

7869

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

13008

56.79%

29 - 90 days

4542

19.83%

> 90 days

5354

23.38%

Total

22904

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

9383

70.23%

Chronic toxicity

3977

29.77%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

13360

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

91483

59.65%

Monoclonal antibody by mouse ascites method

24200

15.78%

Other product types

37690

24.57%

Total

153373

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

368792

64.46%

Legislation on medicinal products for veterinary use and their residues

115003

20.1%

Medical devices legislation

40847

7.14%

Industrial chemicals legislation

7479

1.31%

Plant protection product legislation

7026

1.23%

Biocides legislation

394

0.07%

Food legislation including food contact material

1033

0.18%

Feed legislation including legislation for the safety of target animals, workers and environment

27971

4.89%

Cosmetics legislation

Other legislation

3599

0.63%

Total

572144

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

565901

98.91%

Legislation satisfying national requirements only [within EU]

1871

0.33%

Legislation satisfying Non-EU requirements only

4372

0.76%

Total

572144

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

1886926

99.23%

Yes

14616

0.77%

Total

1901542

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

81482

4.29%

Mild [up to and including]

845322

44.45%

Moderate

782033

41.13%

Severe

192705

10.13%

Total

1901542

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1873951

98.55%

Yes

27591

1.45%

Total

1901542

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1487378

78.22%

Genetically altered without a harmful phenotype

324456

17.06%

Genetically altered with a harmful phenotype

89708

4.72%

Total

1901542

100.00%



France: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period (2015).

The transposition of Directive 2010/63/EU into French law has given rise to significant changes.

Indeed, the format prescribed by the European Union for the retrospective survey for 2016 under Directive 2010/63/EU, which was transposed into French law on 7 February 2013, is different from that used for the previous surveys under Directive 86/609/EU. Any comparison with the 2015 survey would therefore be inappropriate, particularly for the period 2013-2017, which was marked by transitional regulatory measures.

The scope of the survey has changed considerably:

-only animals for which the experimental procedures ended in 2016 are recorded;

-captive-bred animals present in user establishments are excluded;

-animals involved in procedures below the stress threshold, including genetically modified animal lines that do not exhibit a harmful phenotype, are excluded;

-animals humanely killed according to regulatory methods for the removal of organs or tissue (used for alternative methods) are excluded.

2. Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

As the conditions of the statistical survey have changed, its results are not directly comparable with the figures previously published (for 2015). Consequently, any comparative analysis that reached a conclusion regarding an increase or decrease in the number of animals used for scientific purposes would be inappropriate.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

As the conditions of the statistical survey have changed, its results are not directly comparable with the figures previously published (for 2015). Consequently, any comparative analysis of the changes in trends in actual severities would be inappropriate.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The principles of replacement, refinement and reduction have been part of the French policy on the use of animals for scientific purposes since the ten founding measures were introduced in 1992 by the Minister for Research, Hubert Curien. Teaching these principles is an essential part of training staff, whether they are responsible for caring for the animals or for carrying out and designing scientific projects. The work of the National Commission for Animal Testing and the National Ethical Reflection Committee on Animal Testing, which meet several times a year, is crucial in this respect. The transposition of Directive 2010/63/EU, which requires prior authorisation for any project using animals for scientific purposes, and the choice of the French authorities to draw on the expertise of nearly 130 ethical committees spread throughout France, has also encouraged researchers to think more about these three principles and helped increase the sharing of best practice.

5. Further breakdown on the use of “other” categories if a significant proportion of animal use is reported under this category.

Grouping species of the same taxon in the ‘other’ category, as proposed by the European Commission, does not always seem to be the most appropriate method and could be improved, in particular in the case of fish and birds.

For example, although zebra-fish account for just 0.5 % of animals used (11,399 animals), ‘other fish’ account for 21.7 % (413,183 animals). The latter category includes farmed fish such as trout, eel, seabass and salmon, the reproduction, physiology and diet of which are the subject of numerous studies, particularly by the National Institute for Agricultural Research (INRA).

Large numbers of birds are also categorised as ‘other’ (46,433 animals), while ‘domestic fowl’ account for 66,734.

Finally, with respect to the distribution of animals involved in procedures imposed by the rules, particular attention was given to completing this section, which had been misunderstood by users in the previous survey. Only 1% of animals were entered in the ‘other’ category in this survey.

6. Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.’

Procedures are classified into four categories: non-recovery, mild, moderate and severe (including intense/severe procedures). No instances of the ‘severe’ classification being exceeded have been identified.

France: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1144745

59.67%

Rats

172209

8.98%

Guinea-Pigs

44705

2.33%

Hamsters (Syrian)

10481

0.55%

Hamsters (Chinese)

287

0.01%

Mongolian gerbil

817

0.04%

Other Rodents

651

0.03%

Rabbits

117531

6.13%

Cats

1067

0.06%

Dogs

4204

0.22%

Ferrets

160

0.01%

Other carnivores

23

0%

Horses, donkeys and cross-breeds

540

0.03%

Pigs

11707

0.61%

Goats

1025

0.05%

Sheep

5763

0.3%

Cattle

2492

0.13%

Prosimians

1

0%

Marmoset and tamarins

41

0%

Cynomolgus monkey

3170

0.17%

Rhesus monkey

173

0.01%

Vervets (Chlorocebus spp.)

23

0%

Baboons

92

0%

Squirrel monkey

8

0%

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

20

0%

Domestic fowl

56759

2.96%

Other birds

14633

0.76%

Reptiles

4958

0.26%

Rana

36

0%

Xenopus

10078

0.53%

Other Amphibians

2081

0.11%

Zebra fish

13893

0.72%

Other Fish

293589

15.3%

Cephalopods

440

0.02%

Total

1918402

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1611211

85.67%

Animals born in the EU but not at a registered breeder

185781

9.88%

Animals born in rest of Europe

59305

3.15%

Animals born in rest of world

24313

1.29%

Total

1880610

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

126

5.44%

Animals born in rest of Europe

Animals born in Asia

182

7.85%

Animals born in America

12

0.52%

Animals born in Africa

1979

85.38%

Animals born elsewhere

19

0.82%

Total

2318

100.00%



Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

5

0.22%

F1

1030

44.43%

F2 or greater

1272

54.87%

Self-sustaining colony

11

0.47%

Total

2318

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

809504

42.2%

Translational and applied research

482233

25.14%

Regulatory use and Routine production

517479

26.97%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

635

0.03%

Preservation of species

16750

0.87%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

34195

1.78%

Forensic enquiries

28

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

57578

3%

Total

1918402

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

81024

10.01%

Cardiovascular Blood and Lymphatic System

30831

3.81%

Nervous System

133609

16.51%

Respiratory System

7721

0.95%

Gastrointestinal System including Liver

33673

4.16%

Musculoskeletal System

14431

1.78%

Immune System

81497

10.07%

Urogenital/Reproductive System

14140

1.75%

Sensory Organs (skin, eyes and ears)

12221

1.51%

Endocrine System/Metabolism

63208

7.81%

Multisystemic

36302

4.48%

Ethology / Animal Behaviour /Animal Biology

226122

27.93%

Other basic research

74725

9.23%

Total

809504

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

95944

19.9%

Human Infectious Disorders

39380

8.17%

Human Cardiovascular Disorders

10632

2.2%

Human Nervous and Mental Disorders

51007

10.58%

Human Respiratory Disorders

1530

0.32%

Human Gastrointestinal Disorders including Liver

11753

2.44%

Human Musculoskeletal Disorders

12804

2.66%

Human Immune Disorders

19730

4.09%

Human Urogenital/Reproductive Disorders

727

0.15%

Human Sensory Organ Disorders (skin, eyes and ears)

10749

2.23%

Human Endocrine/Metabolism Disorders

17398

3.61%

Other Human Disorders

5443

1.13%

Animal Diseases and Disorders

70126

14.54%

Animal Welfare

749

0.16%

Diagnosis of diseases

115230

23.9%

Plant diseases

56

0.01%

Non-regulatory toxicology and ecotoxicology

18975

3.93%

Total

482233

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

236097

45.62%

Other efficacy and tolerance testing

27122

5.24%

Toxicity and other safety testing including pharmacology

104065

20.11%

Routine production

150195

29.02%

Total

517479

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

25789

10.92%

Pyrogenicity testing

7689

3.26%

Batch potency testing

164164

69.53%

Other quality controls

38455

16.29%

Total

236097

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

4796

4.61%

Skin irritation/corrosion

823

0.79%

Skin sensitisation

13287

12.77%

Eye irritation/corrosion

283

0.27%

Repeated dose toxicity

24301

23.35%

Carcinogenicity

412

0.4%

Genotoxicity

736

0.71%

Reproductive toxicity

16635

15.99%

Developmental toxicity

6451

6.2%

Neurotoxicity

18

0.02%

Kinetics

12205

11.73%

Pharmaco-dynamics (incl safety pharmacology)

10704

10.29%

Phototoxicity

403

0.39%

Ecotoxicity

11352

10.91%

Safety testing in food and feed area

294

0.28%

Target animal safety

58

0.06%

Other toxicity/safety testing

1307

1.26%

Total

104065

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

706

14.72%

Other lethal methods

1256

26.19%

Non lethal methods

2834

59.09%

Total

4796

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

13624

56.06%

29 - 90 days

5861

24.12%

> 90 days

4816

19.82%

Total

24301

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

10156

89.46%

Chronic toxicity

1078

9.5%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

42

0.37%

Other ecotoxicity

76

0.67%

Total

11352

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

73841

49.16%

Monoclonal antibody by mouse ascites method

46128

30.71%

Other product types

30226

20.12%

Total

150195

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

340076

65.72%

Legislation on medicinal products for veterinary use and their residues

79098

15.29%

Medical devices legislation

66507

12.85%

Industrial chemicals legislation

12412

2.4%

Plant protection product legislation

3970

0.77%

Biocides legislation

439

0.08%

Food legislation including food contact material

715

0.14%

Feed legislation including legislation for the safety of target animals, workers and environment

13556

2.62%

Cosmetics legislation

Other legislation

706

0.14%

Total

517479

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

497155

96.07%

Legislation satisfying national requirements only [within EU]

1318

0.25%

Legislation satisfying Non-EU requirements only

19006

3.67%

Total

517479

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

1882928

98.15%

Yes

35474

1.85%

Total

1918402

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

105941

5.52%

Mild [up to and including]

766947

39.98%

Moderate

726836

37.89%

Severe

318678

16.61%

Total

1918402

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1874323

97.7%

Yes

44079

2.3%

Total

1918402

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1501546

78.27%

Genetically altered without a harmful phenotype

372200

19.4%

Genetically altered with a harmful phenotype

44656

2.33%

Total

1918402

100.00%



France: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period (2016).

The 2017 survey comprises the responses of 552 establishments authorised to use animals for scientific purposes, representing an increase of 8.2% compared to 2016, which reflects an improved response rate to the survey.

The number of animals is decreasing (1,914,174 in 2017 compared to 1,918,481 in 2016, amounting to a decrease of 4,307 animals or 0.22%). This decrease is all the more significant since the number of respondents to the 2017 survey is considerably higher than it was in 2016. This trend will be reviewed once the 2018 figures are available at the end of 2019.

The decrease observed is significant and supported by the fact the survey response rate has increased by around 8%.

Apart from the number of animals, the type of species used in experimental procedures, the degree of severity and the proportion of genetically modified animals remain extremely close to the previous year’s figures.

2. Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

The statistics are not yet fully comparable from one year to the next, because France is still in a transitional period in order to implement the Directive. Subject to that reservation, we can nevertheless detect the following trends:

- stable use of non-human primates and a decrease in the number of domestic carnivores (dogs and cats) compared to 2016, which can be linked with concerted efforts made for several years to reduce the use of these sensitive species;

- an increase in the proportion of F2 generation non-human primates, reflecting a gradual shift towards achieving the 100% target set for 2022;

- stable use of genetically modified animals and a large reduction in the proportion of harmful genotypes (2.8% of animals in 2017).

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The actual severity is very stable from one year to the next. There has been a slight increase in the number of animals used in moderate procedures compared to mild procedures (see graph below). However, this change does not appear to be significant: it could be the result of establishments applying the severity assessment criteria better, thanks to the educational work carried out by the ethics committees and the Ministry responsible for research.

Key to graph:

Changes in severity

Mild

Moderate

Severe

Non-recovery


4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

France continues to promote the principles of replacement, refinement and reduction very actively, in particular through an ambitious training programme for staff in charge of both caring for animals and designing and carrying out scientific projects. The work of the National Commission for Animal Testing (CNEA) and the National Ethical Reflection Committee on Animal Testing (CNREEA), each of which meets several times a year, is also crucial.

The national platform for the development of alternative methods (FRANCOPA), which is a member of the European ECOPA network and brings together all stakeholders, also works to promote the three Rs.

The French authorities can also draw on the expertise of almost 130 ethical committees spread throughout France, which, on a local level, all help researchers think more about ethical issues, raise awareness of these three principles and encourage the sharing of best practice.

We believe that the decrease in the average number of animals used per establishment, referred to above (question 1), is partly the result of these efforts.



5. Further breakdown on the use of “other” categories if a significant proportion of animal use is reported under this category.

As in previous years, the ‘other fish’ category remains very large, corresponding to 13.8% of the animals used (267,800 animals). This category includes farmed fish such as trout, eel, seabass and salmon, the reproduction, physiology and diet of which are the subject of numerous studies, particularly by the National Institute for Agricultural Research (INRA).

The ‘other birds’ category still covers 1.4% of animals (27,200 animals), compared to 43,100 ‘domestic fowl’.

6. Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.’

No authorisations were granted in 2017 for requests exceeding the ‘severe’ classification.

France: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1134517

59.27%

Rats

183714

9.6%

Guinea-Pigs

45034

2.35%

Hamsters (Syrian)

6529

0.34%

Hamsters (Chinese)

167

0.01%

Mongolian gerbil

429

0.02%

Other Rodents

957

0.05%

Rabbits

127204

6.65%

Cats

867

0.05%

Dogs

4106

0.21%

Ferrets

148

0.01%

Other carnivores

27

0%

Horses, donkeys and cross-breeds

305

0.02%

Pigs

10346

0.54%

Goats

838

0.04%

Sheep

5396

0.28%

Cattle

1777

0.09%

Prosimians

86

0%

Marmoset and tamarins

224

0.01%

Cynomolgus monkey

3279

0.17%

Rhesus monkey

71

0%

Vervets (Chlorocebus spp.)

38

0%

Baboons

32

0%

Squirrel monkey

7

0%

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

9

0%

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

18525

0.97%

Domestic fowl

43144

2.25%

Other birds

27225

1.42%

Reptiles

3462

0.18%

Rana

118

0.01%

Xenopus

4897

0.26%

Other Amphibians

742

0.04%

Zebra fish

21879

1.14%

Other Fish

268074

14%

Cephalopods

1

0%

Total

1914174

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1564017

83.58%

Animals born in the EU but not at a registered breeder

204920

10.95%

Animals born in rest of Europe

48681

2.6%

Animals born in rest of world

53666

2.87%

Total

1871284

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

236

10.24%

Animals born in rest of Europe

5

0.22%

Animals born in Asia

130

5.64%

Animals born in America

35

1.52%

Animals born in Africa

1729

75.04%

Animals born elsewhere

169

7.34%

Total

2304

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

885

38.41%

F2 or greater

1285

55.77%

Self-sustaining colony

134

5.82%

Total

2304

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

731041

38.19%

Translational and applied research

479372

25.04%

Regulatory use and Routine production

574030

29.99%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

4918

0.26%

Preservation of species

18786

0.98%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

35512

1.86%

Forensic enquiries

8

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

70507

3.68%

Total

1914174

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

94213

12.89%

Cardiovascular Blood and Lymphatic System

32577

4.46%

Nervous System

141408

19.34%

Respiratory System

12314

1.68%

Gastrointestinal System including Liver

28076

3.84%

Musculoskeletal System

17501

2.39%

Immune System

92193

12.61%

Urogenital/Reproductive System

19906

2.72%

Sensory Organs (skin, eyes and ears)

5435

0.74%

Endocrine System/Metabolism

40708

5.57%

Multisystemic

20896

2.86%

Ethology / Animal Behaviour /Animal Biology

164456

22.5%

Other basic research

61358

8.39%

Total

731041

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

120343

25.1%

Human Infectious Disorders

52555

10.96%

Human Cardiovascular Disorders

15203

3.17%

Human Nervous and Mental Disorders

46348

9.67%

Human Respiratory Disorders

6669

1.39%

Human Gastrointestinal Disorders including Liver

12373

2.58%

Human Musculoskeletal Disorders

14481

3.02%

Human Immune Disorders

19048

3.97%

Human Urogenital/Reproductive Disorders

2240

0.47%

Human Sensory Organ Disorders (skin, eyes and ears)

7760

1.62%

Human Endocrine/Metabolism Disorders

12502

2.61%

Other Human Disorders

9742

2.03%

Animal Diseases and Disorders

37943

7.92%

Animal Welfare

216

0.05%

Diagnosis of diseases

97413

20.32%

Plant diseases

89

0.02%

Non-regulatory toxicology and ecotoxicology

24447

5.1%

Total

479372

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

201610

35.12%

Other efficacy and tolerance testing

83928

14.62%

Toxicity and other safety testing including pharmacology

113238

19.73%

Routine production

175254

30.53%

Total

574030

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

20294

10.07%

Pyrogenicity testing

6191

3.07%

Batch potency testing

138017

68.46%

Other quality controls

37108

18.41%

Total

201610

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

3294

2.91%

Skin irritation/corrosion

1754

1.55%

Skin sensitisation

14019

12.38%

Eye irritation/corrosion

253

0.22%

Repeated dose toxicity

24250

21.42%

Carcinogenicity

2295

2.03%

Genotoxicity

486

0.43%

Reproductive toxicity

14165

12.51%

Developmental toxicity

7483

6.61%

Neurotoxicity

Kinetics

18338

16.19%

Pharmaco-dynamics (incl safety pharmacology)

9821

8.67%

Phototoxicity

521

0.46%

Ecotoxicity

13533

11.95%

Safety testing in food and feed area

1570

1.39%

Target animal safety

171

0.15%

Other toxicity/safety testing

1285

1.13%

Total

113238

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

702

21.31%

Other lethal methods

561

17.03%

Non lethal methods

2031

61.66%

Total

3294

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

12892

53.16%

29 - 90 days

6543

26.98%

> 90 days

4815

19.86%

Total

24250

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

10955

80.95%

Chronic toxicity

1107

8.18%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

846

6.25%

Other ecotoxicity

625

4.62%

Total

13533

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

74243

42.36%

Monoclonal antibody by mouse ascites method

44198

25.22%

Other product types

56813

32.42%

Total

175254

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

334865

58.34%

Legislation on medicinal products for veterinary use and their residues

82088

14.3%

Medical devices legislation

64309

11.2%

Industrial chemicals legislation

12737

2.22%

Plant protection product legislation

4541

0.79%

Biocides legislation

757

0.13%

Food legislation including food contact material

698

0.12%

Feed legislation including legislation for the safety of target animals, workers and environment

73260

12.76%

Cosmetics legislation

Other legislation

775

0.14%

Total

574030

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

552522

96.25%

Legislation satisfying national requirements only [within EU]

2643

0.46%

Legislation satisfying Non-EU requirements only

18865

3.29%

Total

574030

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

1873588

97.88%

Yes

40586

2.12%

Total

1914174

100.00%



Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

103094

5.39%

Mild [up to and including]

703783

36.77%

Moderate

780853

40.79%

Severe

326444

17.05%

Total

1914174

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1868750

97.63%

Yes

45424

2.37%

Total

1914174

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1485568

77.61%

Genetically altered without a harmful phenotype

375530

19.62%

Genetically altered with a harmful phenotype

53076

2.77%

Total

1914174

100.00%



Germany

Germany: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

In 2015, approximately 2 million vertebrates and cephalopods were used in Germany in animal experiments within the meaning of Section 7(2) of the German Animal Welfare Act (Tierschutzgesetz). Section 7(2) of the Animal Welfare Act defines the term ‘animal experiment’. The figures are virtually unchanged compared to the previous year. Approximately 82% of the test animals used were rodents, mostly mice and rats, whereby mice comprised approximately 68% of the animals used. Approximately 8% of the animals were fish, approximately 5% were rabbits and approximately 2% were birds.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Killing for scientific purposes

In addition to the guidelines of the EU Laboratory Animals Directive, Germany also includes animals that were killed for scientific purposes without first having undergone procedures or treatments, for instance in order to use these animals’ organs or cell material for scientific purposes. Approximately 755,000 animals were used to this end in 2015, which means that overall approximately 34,000 fewer animals were used than in the previous year.

Genetically modified animals

The number of genetically modified animals has risen slightly in comparison to the previous year. Approximately 1,115,000 of the total number of animals used were genetically modified. As such, the percentage of these animals was approximately 40% (in 2014 this was approximately 34%). In particular mice (91%) and fish (7%) were used.

Primates

The number of primates used also rose slightly. In 2015 a total of 3,141 primates were used, 293 more than in the previous year.

Dogs and cats

The number of dogs and cats used amounted to 4,491 and 1,112 respectively, used in particular to research animal diseases and for the statutory toxicity and safety testing of animal and human medicines. There are no relevant differences compared to the previous year.

Scientific purposes

Although many scientific questions can be answered nowadays through the use of cell cultures, computer-assisted procedures and other alternative methods, it is not yet possible to do without the use of animals for medical research and other scientific purposes. For instance, approximately 48% of the animals used in animal experiments within the meaning of Section 7(2) of the Animal Welfare Act were used for basic research and approximately 15% were used for researching human and animal diseases. Approximately 31% of the animals were used in the manufacture and quality control of medical products or for toxicological safety tests. Approximately 6% were needed for other purposes, such as training or further education or for breeding genetically modified animals.

This means that as compared to 2014 there was an increase in the areas of basic research (approximately 5%) and the manufacture and quality control of medical products or toxicological safety tests (approximately 6%), while in the area of other purposes there was a decrease of approximately 10%.

·Basic research

Within basic research, research into the nervous system (approximately 14%) and the immune system (approximately 27%) was particularly important in 2015. As such, research into the immune system showed an increase of approximately 10% compared to the previous year.

·Human and animal diseases

Under research into human and animal diseases, there was an emphasis on the area of human cancers, for which approximately 37% of test animals used in this field of research were utilised. Here, too, there was an increase of approximately 10% as compared to 2014.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

With regard to the severity of experiments, it is apparent that the severity classification in animal experiments within the meaning of Section 7(2) of the Animal Welfare Act was predominantly ‘low’ (approximately 63%). Here a slight increase as compared to the previous year (approximately 60%) can be seen. The share of animal experiments classified as ‘medium’ or ‘severe’ was approximately 24% and 5% respectively. A slight decrease can be seen as compared to the previous year (21% and 6% respectively). The share of animal experiments that were carried out entirely under general anaesthesia and from which the animal never regained consciousness was approximately 8%. Here as well, a decrease can be seen as compared to 2014 (13%).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The BMEL is endeavouring to reduce the number of animals used in experiments and provides financial support to the Stiftung zur Förderung von Ersatz- und Ergänzungsmethoden zur Einschränkung von Tierversuchen (Foundation for the promotion of alternate and complementary methods to reduce animal experiments), among other organisations, and awards the annual Animal Welfare Research Prize promoting methodological work with the goal of reducing and replacing animal experiments. This prize consists of a monetary award of €15,000. In addition, the German government’s involvement in reducing the number of animals used in experiments is part of the BMEL’s initiative ‘Minding animals – new ways to improve animal welfare’. In the context of this initiative, the Centre for Documentation and Evaluation of Alternatives to Animal Experiments (Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch, ZEBET) within the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung) was expanded into the German Centre for the Protection of Laboratory Animals (Deutsches Zentrum zum Schutz von Versuchstieren, Bf3R).

5. Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

Category ‘other animal species’

In this category, particularly in the areas ‘other rodent species’ and ‘other fish species’, there are a greater number of additional animal species.

Under rodents, the common vole was used in particular. This primarily concerns animals caught in the wild which were re-released after the experiment was finished. These animals were mainly used in the context of research into common vole populations and their development on agricultural land. As a rule the severity classification for the animals involved was ‘low’.

For fish, primarily local wild fish (e.g. common bream, brown trout, common roach, stickleback) were used in the context of basic ethological research. Here, too, this primarily concerns animals caught in the wild which were re-released after the experiment was finished. And here too the severity classification was ‘low’ as a rule.

Category ‘other uses’

The emphasis in this category is in the areas ‘basic research’ and ‘regulatory purposes’.

In the context of basic research there was particular emphasis on the following areas:

·creating and genotyping new genetically modified animal bloodlines as models for human and animal diseases;

·molecular developmental genetics;

·studies of evolutionary changes in humans and animals;

·research into various new methods for marker, blood and biopsy sampling with the goal of refining these methods;

·research into the structure and function of G-protein-coupled receptors;

·research in the field of human and animal microbiology;

·research in the context of gerontology.

As a rule the severity classification for the animals involved was ‘low’.

In addition, in the area of regulatory experiments the following topics of focus were particularly apparent:

·testing new diagnostic and therapeutic procedures in the field of human cancers;

·determining population development in common vole populations on agricultural land in the context of safety tests (e.g. plant protection products);

·propagation of pathogens for developing in vitro diagnostics;

·pharmacodynamic research in the context of developing therapies in the area of human or animal tumour diseases (e.g. radiopharmaceuticals).

As a rule the severity classification for the animals involved was ‘low’.

Category ‘other legal provisions’

In the context of this category, predominantly experiments were carried out to test substances hazardous to water in accordance with the German Administrative Provision concerning the Water Resources Act (Verwaltungsvorschrift zum Wasserhaushaltsgesetz). The severity classification for the animals involved in these experiments varied widely overall (from ‘low’ to ‘severe’).

6.Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

In 2015 there were no experiments carried out in Germany in the context of which the classification exceeded ‘severe’.

Germany: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1400822

68.49%

Rats

263318

12.87%

Guinea-Pigs

18237

0.89%

Hamsters (Syrian)

1390

0.07%

Hamsters (Chinese)

30

0%

Mongolian gerbil

4568

0.22%

Other Rodents

12793

0.63%

Rabbits

110988

5.43%

Cats

1112

0.05%

Dogs

4491

0.22%

Ferrets

230

0.01%

Other carnivores

686

0.03%

Horses, donkeys and cross-breeds

1507

0.07%

Pigs

12305

0.6%

Goats

904

0.04%

Sheep

2290

0.11%

Cattle

4029

0.2%

Prosimians

102

0%

Marmoset and tamarins

292

0.01%

Cynomolgus monkey

2678

0.13%

Rhesus monkey

39

0%

Vervets (Chlorocebus spp.)

Baboons

6

0%

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

1

0%

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1383

0.07%

Domestic fowl

25658

1.25%

Other birds

13663

0.67%

Reptiles

501

0.02%

Rana

132

0.01%

Xenopus

4038

0.2%

Other Amphibians

2190

0.11%

Zebra fish

88147

4.31%

Other Fish

66731

3.26%

Cephalopods

Total

2045261

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1888405

94.58%

Animals born in the EU but not at a registered breeder

82266

4.12%

Animals born in rest of Europe

11491

0.58%

Animals born in rest of world

14466

0.72%

Total

1996628

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

414

17.31%

Animals born in rest of Europe

Animals born in Asia

1237

51.71%

Animals born in America

9

0.38%

Animals born in Africa

732

30.6%

Animals born elsewhere

Total

2392

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

505

21.11%

F2 or greater

1204

50.33%

Self-sustaining colony

683

28.55%

Total

2392

100.00%



Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

975689

47.7%

Translational and applied research

312138

15.26%

Regulatory use and Routine production

629182

30.76%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

5991

0.29%

Preservation of species

29297

1.43%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

49389

2.41%

Forensic enquiries

15

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

43560

2.13%

Total

2045261

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

81162

8.32%

Cardiovascular Blood and Lymphatic System

81552

8.36%

Nervous System

140795

14.43%

Respiratory System

33612

3.44%

Gastrointestinal System including Liver

26877

2.75%

Musculoskeletal System

18068

1.85%

Immune System

263000

26.96%

Urogenital/Reproductive System

20090

2.06%

Sensory Organs (skin, eyes and ears)

27615

2.83%

Endocrine System/Metabolism

43757

4.48%

Multisystemic

49023

5.02%

Ethology / Animal Behaviour /Animal Biology

31730

3.25%

Other basic research

158408

16.24%

Total

975689

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

115200

36.91%

Human Infectious Disorders

21784

6.98%

Human Cardiovascular Disorders

16246

5.2%

Human Nervous and Mental Disorders

47429

15.19%

Human Respiratory Disorders

15252

4.89%

Human Gastrointestinal Disorders including Liver

8736

2.8%

Human Musculoskeletal Disorders

3253

1.04%

Human Immune Disorders

14081

4.51%

Human Urogenital/Reproductive Disorders

5321

1.7%

Human Sensory Organ Disorders (skin, eyes and ears)

3123

1%

Human Endocrine/Metabolism Disorders

20409

6.54%

Other Human Disorders

2224

0.71%

Animal Diseases and Disorders

20203

6.47%

Animal Welfare

4743

1.52%

Diagnosis of diseases

4539

1.45%

Plant diseases

21

0.01%

Non-regulatory toxicology and ecotoxicology

9574

3.07%

Total

312138

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

235332

37.4%

Other efficacy and tolerance testing

45385

7.21%

Toxicity and other safety testing including pharmacology

256282

40.73%

Routine production

92183

14.65%

Total

629182

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

43768

18.6%

Pyrogenicity testing

6992

2.97%

Batch potency testing

184434

78.37%

Other quality controls

138

0.06%

Total

235332

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

8608

3.36%

Skin irritation/corrosion

894

0.35%

Skin sensitisation

11170

4.36%

Eye irritation/corrosion

225

0.09%

Repeated dose toxicity

22769

8.88%

Carcinogenicity

5053

1.97%

Genotoxicity

4167

1.63%

Reproductive toxicity

22388

8.74%

Developmental toxicity

15019

5.86%

Neurotoxicity

90

0.04%

Kinetics

37692

14.71%

Pharmaco-dynamics (incl safety pharmacology)

88650

34.59%

Phototoxicity

12

0%

Ecotoxicity

31374

12.24%

Safety testing in food and feed area

Target animal safety

1601

0.62%

Other toxicity/safety testing

6570

2.56%

Total

256282

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

3559

41.35%

Other lethal methods

117

1.36%

Non lethal methods

4932

57.3%

Total

8608

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

17256

75.79%

29 - 90 days

3132

13.76%

> 90 days

2381

10.46%

Total

22769

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

8021

25.57%

Chronic toxicity

6288

20.04%

Reproductive ecotoxicity

1643

5.24%

Endocrine activity

8258

26.32%

Bioaccumulation

1858

5.92%

Other ecotoxicity

5306

16.91%

Total

31374

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

86209

93.52%

Monoclonal antibody by mouse ascites method

894

0.97%

Other product types

5080

5.51%

Total

92183

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

441537

70.18%

Legislation on medicinal products for veterinary use and their residues

38179

6.07%

Medical devices legislation

61866

9.83%

Industrial chemicals legislation

50563

8.04%

Plant protection product legislation

31544

5.01%

Biocides legislation

1200

0.19%

Food legislation including food contact material

38

0.01%

Feed legislation including legislation for the safety of target animals, workers and environment

1638

0.26%

Cosmetics legislation

Other legislation

2617

0.42%

Total

629182

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

593854

94.39%

Legislation satisfying national requirements only [within EU]

19377

3.08%

Legislation satisfying Non-EU requirements only

15951

2.54%

Total

629182

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

1999020

97.74%

Yes

46241

2.26%

Total

2045261

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

159720

7.81%

Mild [up to and including]

1282093

62.69%

Moderate

489855

23.95%

Severe

113593

5.55%

Total

2045261

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1889941

92.41%

Yes

155320

7.59%

Total

2045261

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1304619

63.79%

Genetically altered without a harmful phenotype

626034

30.61%

Genetically altered with a harmful phenotype

114608

5.6%

Total

2045261

100.00%



Germany: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

In 2016, approximately 2 million vertebrates and cephalopods were used in Germany in animal experiments within the meaning of Section 7(2) of the German Animal Welfare Act (Tierschutzgesetz). Section 7(2) of the Animal Welfare Act defines the term ‘animal experiment’. The figures are virtually unchanged compared to the previous year. Approximately 79% of the test animals used were rodents, mostly mice and rats, whereby mice comprised approximately 66% of the animals used. Approximately 12% of the animals were fish, approximately 5% were rabbits and approximately 2% were birds.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Killing for scientific purposes

In addition to the guidelines of the EU Laboratory Animals Directive, Germany also includes animals that were killed for scientific purposes without first having undergone procedures or treatments, for instance in order to use these animals’ organs or cell material for scientific purposes. Approximately 726,000 animals were used to this end in 2016, which means that overall approximately 29,000 fewer animals were used than in the previous year.

Genetically modified animals

The number of genetically modified animals has risen slightly in comparison to the previous year. Approximately 1,200,000 of the total number of animals used were genetically modified. As such, the percentage of these animals was approximately 42% (in 2015 this was approximately 40%). In particular mice (86%) and fish (12%) were used.

Primates

The number of primates used also showed a definite decrease. In 2015 a total of 2,462 primates were used, 679 fewer than in the previous year.

Dogs and cats

The number of dogs and cats used amounted to 3,977 and 766 respectively, used in particular to research animal diseases and for the statutory toxicity and safety testing of animal and human medicines. As compared to the previous year, there was a decrease in the number of dogs (4,491 in 2015) and cats (1,112 in 2015).

Scientific purposes

Although many scientific questions can be answered nowadays through the use of cell cultures, computer-assisted procedures and other alternative methods, it is not yet possible to do without the use of animals for medical research and other scientific purposes. For instance, approximately 53% of the animals used in animal experiments within the meaning of Section 7(2) of the Animal Welfare Act were used for basic research and approximately 14% were used for researching human and animal diseases. Approximately 26% of the animals were used in the manufacture and quality control of medical products or for toxicological safety tests. Approximately 7% were needed for other purposes, such as training or further education or for breeding genetically modified animals.

This means that as compared to 2015 there was an increase in the area of basic research (approximately 5%), while in the area of the manufacture and quality control of medical products or toxicological safety tests there was a decrease of approximately 6%.

·Basic research

Within basic research, research into the nervous system (approximately 15%) and the immune system (approximately 20%) was particularly important in 2016. As such, research into the immune system showed a decrease of approximately 7% compared to the previous year.

·Human and animal diseases

Under research into human and animal diseases, there was an emphasis on the area of human cancers, for which approximately 37% of test animals used in this field of research were utilised. No change can be seen here as compared to 2015.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

With regard to the severity of experiments, it is apparent that the severity classification in animal experiments within the meaning of Section 7(2) of the Animal Welfare Act was predominantly ‘low’ (approximately 63%). The share of animal experiments classified as ‘medium’ or ‘severe’ was approximately 23% and 7% respectively. Compared to the previous year, the number of experiments classified as ‘severe’ showed a slight increase of approximately 2%. The share of animal experiments that were carried out entirely under general anaesthesia and from which the animal never regained consciousness was approximately 7% and thereby at the level of the previous year (approximately 8%).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The BMEL is endeavouring to reduce the number of animals used in experiments and provides financial support to the Stiftung zur Förderung von Ersatz- und Ergänzungsmethoden zur Einschränkung von Tierversuchen (Foundation for the promotion of alternate and complementary methods to reduce animal experiments), among other organisations, and awards the annual Animal Welfare Research Prize promoting methodological work with the goal of reducing and replacing animal experiments. In 2016 the amount of the prize was increased from €15,000 to €25,000. In addition, the German government’s involvement in reducing the number of animals used in experiments is part of the BMEL’s initiative ‘Minding animals - new ways to improve animal welfare’.

5. Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

Category ‘other animal species’

In this category, particularly in the areas ‘other fish species’ and ‘other bird species’, there are a greater number of additional animal species.

For fish, primarily local wild fish (e.g. grayling, common roach, stickleback, common nase) were used in the contexts of basic ethological research and research into species conservation. This partially concerned animals caught in the wild which were re-released after the experiment was finished. As a rule the severity classification was ‘low’.

Among birds, primarily turkeys and local wild bird species (e.g. tit, pheasant, common buzzard, pigeon) were used. While turkeys were mainly used in the context of researching various animal diseases, the various wild bird species were used in the context of basic ethological research. This primarily concerned animals caught in the wild which were re-released after the experiment was finished. As a rule the severity classification for the animals involved was ‘low’.

Category ‘other uses’

The emphasis in this category is in the areas ‘basic research’ and ‘regulatory purposes’.

In the context of basic research there was particular emphasis on the following areas:

·creating and genotyping new genetically modified animal bloodlines as models for human and animal diseases;

·molecular developmental genetics;

·research into various new methods for marker, blood and biopsy sampling with the goal of refining these methods;

·research in the field of human and animal microbiology;

·research in the context of gerontology.

As a rule the severity classification for the animals involved was ‘low’.

In addition, in the area of regulatory experiments the following topics of focus were particularly apparent:

·testing new diagnostic and therapeutic procedures in the field of human cancers;

·determining population development in common vole populations on agricultural land in the context of safety tests (e.g. plant protection products);

·propagation of pathogens for developing in vitro diagnostics;

·pharmacodynamic research in the context of developing therapies in the area of human or animal tumour diseases (e.g. radiopharmaceuticals).

As a rule the severity classification for the animals involved was ‘low’.

Category ‘other legal provisions’

In the context of this category the following other legal provisions are particularly referred to:

·test of substances hazardous to water in accordance with the German Administrative Provision concerning the Water Resources Act (Verwaltungsvorschrift zum Wasserhaushaltsgesetz);

·test of products in accordance with Regulation (EC) No 1272/2008 (fibre persistence test);

·test of products in the framework of the German Infection Protection Act (Infektionsschutzgesetz);

·test of products in accordance with the German Animal Vaccine Regulation (Tierimpfstoffverordnung).

The severity classification for the animals involved in these experiments varied widely overall (from ‘low’ to ‘severe’).

6. Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

In 2016 there were no experiments carried out in Germany in the context of which the classification exceeded ‘severe’.

Germany: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1400971

65.83%

Rats

244274

11.48%

Guinea-Pigs

14184

0.67%

Hamsters (Syrian)

1101

0.05%

Hamsters (Chinese)

2

0%

Mongolian gerbil

4769

0.22%

Other Rodents

6639

0.31%

Rabbits

98331

4.62%

Cats

766

0.04%

Dogs

3964

0.19%

Ferrets

130

0.01%

Other carnivores

474

0.02%

Horses, donkeys and cross-breeds

1270

0.06%

Pigs

16727

0.79%

Goats

223

0.01%

Sheep

3750

0.18%

Cattle

5432

0.26%

Prosimians

117

0.01%

Marmoset and tamarins

113

0.01%

Cynomolgus monkey

2058

0.1%

Rhesus monkey

86

0%

Vervets (Chlorocebus spp.)

18

0%

Baboons

8

0%

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

18

0%

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1143

0.05%

Domestic fowl

29853

1.4%

Other birds

16554

0.78%

Reptiles

454

0.02%

Rana

930

0.04%

Xenopus

5237

0.25%

Other Amphibians

2675

0.13%

Zebra fish

178224

8.37%

Other Fish

87759

4.12%

Cephalopods

Total

2128254

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1951771

94.31%

Animals born in the EU but not at a registered breeder

94479

4.57%

Animals born in rest of Europe

9258

0.45%

Animals born in rest of world

14101

0.68%

Total

2069609

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

192

10.89%

Animals born in rest of Europe

2

0.11%

Animals born in Asia

1039

58.93%

Animals born in America

Animals born in Africa

530

30.06%

Animals born elsewhere

Total

1763

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

403

22.86%

F2 or greater

895

50.77%

Self-sustaining colony

465

26.38%

Total

1763

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1117731

52.52%

Translational and applied research

307138

14.43%

Regulatory use and Routine production

554982

26.08%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

8101

0.38%

Preservation of species

40387

1.9%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

48931

2.3%

Forensic enquiries

28

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

50956

2.39%

Total

2128254

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

84836

7.59%

Cardiovascular Blood and Lymphatic System

101807

9.11%

Nervous System

168180

15.05%

Respiratory System

24355

2.18%

Gastrointestinal System including Liver

31097

2.78%

Musculoskeletal System

19328

1.73%

Immune System

220107

19.69%

Urogenital/Reproductive System

25928

2.32%

Sensory Organs (skin, eyes and ears)

28599

2.56%

Endocrine System/Metabolism

117143

10.48%

Multisystemic

137863

12.33%

Ethology / Animal Behaviour /Animal Biology

35228

3.15%

Other basic research

123260

11.03%

Total

1117731

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

115230

37.52%

Human Infectious Disorders

22052

7.18%

Human Cardiovascular Disorders

14597

4.75%

Human Nervous and Mental Disorders

41343

13.46%

Human Respiratory Disorders

16124

5.25%

Human Gastrointestinal Disorders including Liver

10359

3.37%

Human Musculoskeletal Disorders

3572

1.16%

Human Immune Disorders

14685

4.78%

Human Urogenital/Reproductive Disorders

3773

1.23%

Human Sensory Organ Disorders (skin, eyes and ears)

5713

1.86%

Human Endocrine/Metabolism Disorders

14638

4.77%

Other Human Disorders

4223

1.37%

Animal Diseases and Disorders

23117

7.53%

Animal Welfare

7202

2.34%

Diagnosis of diseases

3412

1.11%

Plant diseases

17

0.01%

Non-regulatory toxicology and ecotoxicology

7081

2.31%

Total

307138

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

186497

33.6%

Other efficacy and tolerance testing

45456

8.19%

Toxicity and other safety testing including pharmacology

228227

41.12%

Routine production

94802

17.08%

Total

554982

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

27627

14.81%

Pyrogenicity testing

347

0.19%

Batch potency testing

155904

83.6%

Other quality controls

2619

1.4%

Total

186497

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

7255

3.18%

Skin irritation/corrosion

758

0.33%

Skin sensitisation

8604

3.77%

Eye irritation/corrosion

200

0.09%

Repeated dose toxicity

18970

8.31%

Carcinogenicity

799

0.35%

Genotoxicity

2743

1.2%

Reproductive toxicity

14000

6.13%

Developmental toxicity

17916

7.85%

Neurotoxicity

166

0.07%

Kinetics

30657

13.43%

Pharmaco-dynamics (incl safety pharmacology)

92116

40.36%

Phototoxicity

Ecotoxicity

27424

12.02%

Safety testing in food and feed area

86

0.04%

Target animal safety

3905

1.71%

Other toxicity/safety testing

2628

1.15%

Total

228227

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

4278

58.97%

Other lethal methods

301

4.15%

Non lethal methods

2676

36.88%

Total

7255

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

12698

66.94%

29 - 90 days

4491

23.67%

> 90 days

1781

9.39%

Total

18970

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

6189

22.57%

Chronic toxicity

10807

39.41%

Reproductive ecotoxicity

1465

5.34%

Endocrine activity

5940

21.66%

Bioaccumulation

2831

10.32%

Other ecotoxicity

192

0.7%

Total

27424

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

88584

93.44%

Monoclonal antibody by mouse ascites method

2147

2.26%

Other product types

4071

4.29%

Total

94802

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

389067

70.1%

Legislation on medicinal products for veterinary use and their residues

29785

5.37%

Medical devices legislation

56928

10.26%

Industrial chemicals legislation

36967

6.66%

Plant protection product legislation

33617

6.06%

Biocides legislation

2077

0.37%

Food legislation including food contact material

3

0%

Feed legislation including legislation for the safety of target animals, workers and environment

3068

0.55%

Cosmetics legislation

Other legislation

3470

0.63%

Total

554982

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

501983

90.45%

Legislation satisfying national requirements only [within EU]

51318

9.25%

Legislation satisfying Non-EU requirements only

1681

0.3%

Total

554982

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

2071372

97.33%

Yes

56882

2.67%

Total

2128254

100.00%



Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

146265

6.87%

Mild [up to and including]

1324548

62.24%

Moderate

500009

23.49%

Severe

157432

7.4%

Total

2128254

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

2027088

95.25%

Yes

101166

4.75%

Total

2128254

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1273498

59.84%

Genetically altered without a harmful phenotype

723600

34%

Genetically altered with a harmful phenotype

131156

6.16%

Total

2128254

100.00%



Germany: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In 2017, approximately 2 million vertebrates and cephalopods were used in Germany in animal experiments within the meaning of Section 7(2) of the German Animal Welfare Act (Tierschutzgesetz). Section 7(2) of the Animal Welfare Act defines the term ‘animal experiment’. The figures are virtually unchanged compared to the previous year. Approximately 80% of the test animals used were rodents, mostly mice and rats, whereby mice comprised approximately 66% of the animals used. Approximately 12% of the animals were fish, approximately 5% were rabbits and approximately 2% were birds. Here, too, the figures are virtually unchanged compared to the previous year.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Killing for scientific purposes

In addition to the guidelines of the EU Laboratory Animals Directive, Germany also includes animals that were killed for scientific purposes without first having undergone procedures or treatments, for instance in order to use these animals’ organs or cell material for scientific purposes. Approximately 736,000 animals were used to this end in 2017, which means that overall approximately 11,000 more animals were used than in the previous year. Correspondingly, these animals are not included in the numbers of experimental animals submitted to the European Commission.

Genetically modified animals

The number of genetically modified animals has remained largely stable in comparison to the previous year. Approximately 1,150,000 of the total number of animals used were genetically modified. As such, the percentage of these animals was approximately 41% (in 2016 this was approximately 42%). In particular mice (89%) and fish (10%) were used.

Primates

However, the number of primates used showed a definite increase. In 2017 a total of 3,525 primates were used, 1,063 more than in the previous year.

Simians have a genome that is comparable to that of humans, and their total bodily function is also more similar to that of humans. Therefore it is likely that some diseases that cannot be imitated well in the mouse by means of genetic modification can present well in simians in this way. These genetically modified simians could result in a major step towards better understanding very significant, hitherto incurable and terminal diseases and therefore put new therapies within our grasp.

Dogs and cats

The number of dogs and cats used amounted to 3,334 and 718 respectively, used in particular for statutory testing and for applied research. As compared to the previous year, there was an overall decrease in the number of dogs (3,977 in 2016) and cats (766 in 2016).

Scientific purposes

Although many scientific questions can be answered nowadays through the use of cell cultures, computer-assisted procedures and other alternative methods, it is not yet possible to do without the use of animals for medical research and other scientific purposes. For instance, approximately 50% of the animals used in animal experiments within the meaning of Section 7(2) of the Animal Welfare Act were used for basic research and approximately 15% were used for researching human and animal diseases. Approximately 27% of the animals were used in the manufacture and quality control of medical products or for toxicological safety tests. Approximately 8% were needed for other purposes, such as training or further education or for breeding genetically modified animals.

This means that as compared to 2016 there was a slight decrease in the area of basic research (approximately 3%), while the other areas each saw a minimal increase of approximately 1%.

·Basic research

Within basic research, research into the nervous system (approximately 21%) and the immune system (approximately 20%) was particularly important in 2017. As such, research into the nervous system showed an increase of approximately 6% compared to the previous year.

·Human and animal diseases

Under research into human and animal diseases, there was an emphasis on the area of human cancers, for which approximately 41% of test animals used in this field of research were utilised. This is a slight increase as compared to 2016 (approximately 37%).

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

With regard to the severity of experiments, it is apparent that the severity classification in animal experiments within the meaning of Section 7(2) of the Animal Welfare Act was predominantly ‘low’ (approximately 59%). The share of animal experiments classified as ‘medium’ or ‘severe’ was approximately 27% and 5% respectively. Compared to the previous year, the number of experiments classified as ‘medium’ showed a slight increase of 4%, while the number of experiments classified as ‘severe’ showed a slight decrease of approximately 2%. The share of animal experiments that were carried out entirely under general anaesthesia and from which the animal never regained consciousness was approximately 9% and thereby at a slightly higher level than the previous year (approximately 7%).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The German Federal Ministry of Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft, BMEL) is endeavouring to reduce the number of animals used in experiments. For this reason various projects are initiated and supported with the goal of replacing animal experiments with alternative methods as soon as possible. These projects include establishing and operating the German Centre for the Protection of Laboratory Animals (Deutsches Zentrum zum Schutz von Versuchstieren, Bf3R), promoting research by the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR), supporting the Stiftung zur Förderung von Ersatz- und Ergänzungsmethoden zur Einschränkung von Tierversuchen (Foundation for the promotion of alternate and complementary methods to reduce animal experiments) and annually awarding the BMEL’s Animal Welfare Research Prize. In 2016 the amount of the prize was increased from €15,000 to €25,000.

5. Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

Category ‘other animal species’

In this category, particularly in the areas ‘other fish species’ and ‘other bird species’, there are a greater number of additional animal species.

For fish, primarily local wild fish (e.g. grayling, common roach, stickleback, brown trout) were used in the contexts of basic ethological research and research into species conservation. This partially concerned animals caught in the wild which were re-released after the experiment was finished. As a rule the severity classification was ‘low’.

Among birds, primarily turkeys and local wild bird species (e.g. tit, duck, common buzzard, pigeon) were used. While turkeys were mainly used in the context of researching various animal diseases, the various wild bird species were used in the context of basic ethological research. This primarily concerned animals caught in the wild which were re-released after the experiment was finished. As a rule the severity classification for the animals involved was ‘low’.

Moreover, in the areas ‘other carnivores’ and ‘other amphibians’ there were a smaller number of additional species. For instance, among carnivores minks were particularly used in the context of vaccine tolerability testing, while in the area of amphibians primarily the common toad, fire salamander, axolotl and common frog were used with the aim of protecting the natural environment in the interest of human and animal health or welfare.

Category ‘other uses’

The emphasis in this category is in the areas ‘basic research’ and ‘regulatory purposes’.

In the context of basic research there was particular emphasis on the following areas:

·creating and genotyping new genetically modified animal bloodlines as models for human and animal diseases;

·molecular developmental genetics;

·research into various new methods for marker, blood and biopsy sampling with the goal of refining these methods;

·research in the field of human and animal microbiology;

·research in the context of gerontology.

As a rule the severity classification for the animals involved was between ‘low’ and ‘medium’.

In addition, in the area of regulatory experiments the following topics of focus were particularly apparent:

·testing new diagnostic and therapeutic procedures in the field of human cancers;

·testing the effectiveness and mechanism of feed additives;

·pharmacodynamic research in the context of developing therapies in the area of human or animal tumour diseases (e.g. radiopharmaceuticals).

As a rule the severity classification for the animals involved was between ‘low’ and ‘medium’.

Category ‘other legal provisions’

In the context of this category the following other legal provisions are particularly referred to:

·test of substances hazardous to water in accordance with the German Administrative Provision concerning the Water Resources Act (Verwaltungsvorschrift zum Wasserhaushaltsgesetz);

·test of products in accordance with Regulation (EC) No 1272/2008 (fibre persistence test);

·test of products in the framework of the German Infection Protection Act (Infektionsschutzgesetz);

·test of products in accordance with the German Animal Vaccine Regulation (Tierimpfstoffverordnung).

The severity classification for the animals involved in these experiments varied widely overall (from ‘low’ to ‘severe’).

6. Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

In 2017 there were no experiments carried out in Germany in the context of which the classification exceeded ‘severe’.

Germany: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1368447

66.15%

Rats

255449

12.35%

Guinea-Pigs

14851

0.72%

Hamsters (Syrian)

1222

0.06%

Hamsters (Chinese)

8

0%

Mongolian gerbil

4255

0.21%

Other Rodents

9950

0.48%

Rabbits

92661

4.48%

Cats

718

0.03%

Dogs

3330

0.16%

Ferrets

196

0.01%

Other carnivores

535

0.03%

Horses, donkeys and cross-breeds

1209

0.06%

Pigs

17347

0.84%

Goats

212

0.01%

Sheep

3053

0.15%

Cattle

6332

0.31%

Prosimians

87

0%

Marmoset and tamarins

224

0.01%

Cynomolgus monkey

3002

0.15%

Rhesus monkey

117

0.01%

Vervets (Chlorocebus spp.)

15

0%

Baboons

14

0%

Squirrel monkey

1

0%

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

12

0%

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1352

0.07%

Domestic fowl

24920

1.2%

Other birds

12000

0.58%

Reptiles

369

0.02%

Rana

377

0.02%

Xenopus

4546

0.22%

Other Amphibians

2652

0.13%

Zebra fish

141676

6.85%

Other Fish

97674

4.72%

Cephalopods

Total

2068813

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1900118

93.64%

Animals born in the EU but not at a registered breeder

100821

4.97%

Animals born in rest of Europe

15127

0.75%

Animals born in rest of world

13056

0.64%

Total

2029122

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

360

13.39%

Animals born in rest of Europe

Animals born in Asia

1699

63.21%

Animals born in America

Animals born in Africa

628

23.36%

Animals born elsewhere

1

0.04%

Total

2688

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

338

12.57%

F2 or greater

1786

66.44%

Self-sustaining colony

564

20.98%

Total

2688

100.00%



Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1039225

50.23%

Translational and applied research

304599

14.72%

Regulatory use and Routine production

556946

26.92%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

8491

0.41%

Preservation of species

41156

1.99%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

53121

2.57%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

65275

3.16%

Total

2068813

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

91387

8.79%

Cardiovascular Blood and Lymphatic System

109053

10.49%

Nervous System

216128

20.8%

Respiratory System

23579

2.27%

Gastrointestinal System including Liver

33087

3.18%

Musculoskeletal System

25657

2.47%

Immune System

202581

19.49%

Urogenital/Reproductive System

23426

2.25%

Sensory Organs (skin, eyes and ears)

27801

2.68%

Endocrine System/Metabolism

57885

5.57%

Multisystemic

57475

5.53%

Ethology / Animal Behaviour /Animal Biology

46306

4.46%

Other basic research

124860

12.01%

Total

1039225

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

125614

41.24%

Human Infectious Disorders

18388

6.04%

Human Cardiovascular Disorders

16923

5.56%

Human Nervous and Mental Disorders

38573

12.66%

Human Respiratory Disorders

13371

4.39%

Human Gastrointestinal Disorders including Liver

15898

5.22%

Human Musculoskeletal Disorders

3939

1.29%

Human Immune Disorders

11659

3.83%

Human Urogenital/Reproductive Disorders

4784

1.57%

Human Sensory Organ Disorders (skin, eyes and ears)

6500

2.13%

Human Endocrine/Metabolism Disorders

12138

3.98%

Other Human Disorders

1227

0.4%

Animal Diseases and Disorders

17368

5.7%

Animal Welfare

6271

2.06%

Diagnosis of diseases

2488

0.82%

Plant diseases

69

0.02%

Non-regulatory toxicology and ecotoxicology

9389

3.08%

Total

304599

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

188089

33.77%

Other efficacy and tolerance testing

32991

5.92%

Toxicity and other safety testing including pharmacology

260473

46.77%

Routine production

75393

13.54%

Total

556946

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

19382

10.3%

Pyrogenicity testing

5591

2.97%

Batch potency testing

161272

85.74%

Other quality controls

1844

0.98%

Total

188089

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

10357

3.98%

Skin irritation/corrosion

884

0.34%

Skin sensitisation

8711

3.34%

Eye irritation/corrosion

171

0.07%

Repeated dose toxicity

19136

7.35%

Carcinogenicity

1961

0.75%

Genotoxicity

3522

1.35%

Reproductive toxicity

21926

8.42%

Developmental toxicity

35887

13.78%

Neurotoxicity

86

0.03%

Kinetics

31782

12.2%

Pharmaco-dynamics (incl safety pharmacology)

79250

30.43%

Phototoxicity

Ecotoxicity

38843

14.91%

Safety testing in food and feed area

1721

0.66%

Target animal safety

3423

1.31%

Other toxicity/safety testing

2813

1.08%

Total

260473

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

4136

39.93%

Other lethal methods

182

1.76%

Non lethal methods

6039

58.31%

Total

10357

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

13183

68.89%

29 - 90 days

4136

21.61%

> 90 days

1817

9.5%

Total

19136

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

6957

17.91%

Chronic toxicity

16704

43%

Reproductive ecotoxicity

904

2.33%

Endocrine activity

5840

15.03%

Bioaccumulation

1807

4.65%

Other ecotoxicity

6631

17.07%

Total

38843

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

73520

97.52%

Monoclonal antibody by mouse ascites method

384

0.51%

Other product types

1489

1.97%

Total

75393

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

372333

66.85%

Legislation on medicinal products for veterinary use and their residues

23641

4.24%

Medical devices legislation

54817

9.84%

Industrial chemicals legislation

50724

9.11%

Plant protection product legislation

46229

8.3%

Biocides legislation

2366

0.42%

Food legislation including food contact material

14

0%

Feed legislation including legislation for the safety of target animals, workers and environment

3554

0.64%

Cosmetics legislation

Other legislation

3268

0.59%

Total

556946

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

543850

97.65%

Legislation satisfying national requirements only [within EU]

4078

0.73%

Legislation satisfying Non-EU requirements only

9018

1.62%

Total

556946

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

2031810

98.21%

Yes

37003

1.79%

Total

2068813

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

178095

8.61%

Mild [up to and including]

1226990

59.31%

Moderate

548621

26.52%

Severe

115107

5.56%

Total

2068813

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

1891562

91.43%

Yes

177251

8.57%

Total

2068813

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1241283

60%

Genetically altered without a harmful phenotype

658801

31.84%

Genetically altered with a harmful phenotype

168729

8.16%

Total

2068813

100.00%



Greece

Greece: Narrative 2015

1.General information on any changes in trends observed since the previous reporting period.

An increasing trend in the use of animals used for scientific purposes may be observed in 2015 compared to 2014. This is justified due to the fact that a lot of European research projects, which were funded by the European Union (ERC) were performed. 2015 has been a period where applications to receive funding from HORIZON 2020 were pending or were in the process to be approved.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

A) A significant use of fish is depicted in Greek statistical data in 2015 compared to other MS. This is due to the fact that Greece is a Mediterranean country and has a number of user establishments dealing with studies on fish biology, behaviour/ethology and production methods of aquaculture species. Dicentrarchus labrax and Sparus aurata are the main species used. In user establishments, fishes are maintained under similar commercial production conditions, and most of the projects consist of variations in the rearing parameters (temperature, photoperiod, dissolved oxygen, tank size, feed type and frequency, rearing density, etc.) that may cause stress to the animals and are classified as “mild”.

B) A 4-fold increase of use of domestic fowls is being recorded for 2015 and can be attributed the authorisation of more relevant protocols in a user establishment with the implementation of “mild” procedures.

C) A decrease in the use of mice is noted compared to 2014, which can be attributed to the research projects performed

D) There is an increasing trend regarding the reuse of animals in the context of an attempt to reduce the number of animals used for scientific purposes.

E) A significant increase in the use of genetically altered animals without a harmful genotype by approximately 20% can be attributed to the HORIZON 2020 related projects.

F) The use of dogs and cats is mainly focused on basic veterinary research purposes aiming to better study and manage special conditions that affect companion animals, such wound and fracture healing or gastrointestinal reflux.

G) The category referred as “animals born in rest of world” is related to genetically altered rodent provided from USA Institutes for special projects.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

An increase of “severe” use of animals is reported for 2015 compared to 2014 and is attributed to projects which included complicated surgical techniques, oncology and toxicology tests for regulatory use and routine production.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Laboratory Animal Science accredited courses take place in Greece annually, which promote this principle.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

A significant proportion of other fish is reported in Greece for 2015. Greece is a leading country in Mediterranean fish production and significant research is carried out in this field compared to other MS. Sparus aurata and Dicentrarchus labrax are the leading species, with Argyrosomous regius and Seriola dumerili to follow. Procedures on fish include behavioural studies or drug testing, which cause stress to the animals and are classified as “mild”.

In one case legislation on medicinal products for veterinary use and their residues is recorded.

Rodents have been used for various ‘other” purposes in 2015, but not in an exceptional trend.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No such case reported for 2015.

Greece: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

28849

53.67%

Rats

2205

4.1%

Guinea-Pigs

11

0.02%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

611

1.14%

Cats

47

0.09%

Dogs

4

0.01%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

430

0.8%

Goats

Sheep

8

0.01%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

3

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

1606

2.99%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

200

0.37%

Zebra fish

4675

8.7%

Other Fish

15099

28.09%

Cephalopods

Total

53748

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

53337

99.96%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

20

0.04%

Total

53357

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

1

100%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

1

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

1

100%

Self-sustaining colony

Total

1

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

38599

71.81%

Translational and applied research

6463

12.02%

Regulatory use and Routine production

7589

14.12%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1097

2.04%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

53748

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

4102

10.63%

Cardiovascular Blood and Lymphatic System

6710

17.38%

Nervous System

1541

3.99%

Respiratory System

124

0.32%

Gastrointestinal System including Liver

896

2.32%

Musculoskeletal System

908

2.35%

Immune System

3325

8.61%

Urogenital/Reproductive System

179

0.46%

Sensory Organs (skin, eyes and ears)

745

1.93%

Endocrine System/Metabolism

1110

2.88%

Multisystemic

1098

2.84%

Ethology / Animal Behaviour /Animal Biology

14299

37.05%

Other basic research

3562

9.23%

Total

38599

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

915

14.16%

Human Infectious Disorders

470

7.27%

Human Cardiovascular Disorders

1

0.02%

Human Nervous and Mental Disorders

967

14.96%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

160

2.48%

Human Musculoskeletal Disorders

1825

28.24%

Human Immune Disorders

205

3.17%

Human Urogenital/Reproductive Disorders

12

0.19%

Human Sensory Organ Disorders (skin, eyes and ears)

90

1.39%

Human Endocrine/Metabolism Disorders

83

1.28%

Other Human Disorders

404

6.25%

Animal Diseases and Disorders

Animal Welfare

165

2.55%

Diagnosis of diseases

788

12.19%

Plant diseases

Non-regulatory toxicology and ecotoxicology

378

5.85%

Total

6463

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Toxicity and other safety testing including pharmacology

7580

99.88%

Routine production

9

0.12%

Total

7589

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

800

10.55%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Safety testing in food and feed area

6780

89.45%

Total

7580

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

800

100%

Other lethal methods

Non lethal methods

Total

800

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

9

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

9

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

9

0.12%

Legislation on medicinal products for veterinary use and their residues

800

10.54%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

6780

89.34%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

7589

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

7589

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

7589

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

53358

99.27%

Yes

390

0.73%

Total

53748

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

949

1.77%

Mild [up to and including]

37804

70.34%

Moderate

11905

22.15%

Severe

3090

5.75%

Total

53748

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

51409

95.65%

Yes

2339

4.35%

Total

53748

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

40705

75.73%

Genetically altered without a harmful phenotype

11085

20.62%

Genetically altered with a harmful phenotype

1958

3.64%

Total

53748

100.00%



Greece: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

Any significant changes of trends observed in 2016 compared to 2015 regarding the purpose of authorised projects can be attributed to their nature and number. This is directly related to funding resources and the choice of research purpose by user establishments.

A significant decrease in the use of animals for the creation of new genetic lines is reported and can be attributed to the lack of relevant funding by European research projects or absence of relevant application forms by researchers.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

A) A significant use of fish is depicted in Greek statistical data in 2016 compared to other MS. This is due to the fact that Greece is a Mediterranean country and has a number of user establishments dealing with studies on fish biology, behaviour/ethology and production methods of aquaculture species. Dicentrarchus labrax and Sparus aurata are the main species used. In user establishments, fishes are maintained under similar commercial production conditions, and most of the projects consist of variations in the rearing parameters (temperature, photoperiod, dissolved oxygen, tank size, feed type and frequency, rearing density, etc.) that may cause stress to the animals and are classified as “mild”.

B) A 2-fold increase of use of domestic fowls is being recorded for 2016 and can be attributed to the authorisation of more relevant protocols in a user establishment with the implementation of “mild” procedures.

C) A decrease in the use of mice is noted compared to 2015, which can be attributed to the research projects performed during 2016.

D) A significant decrease in the use of genetically altered animals without a harmful phenotype by approximately 5% and an increase of genetically altered animals with a harmful phenotype can be attributed to relevant authorised projects.

E) The use of dogs and cats is mainly focused on basic veterinary research purposes aiming to better study and manage special conditions that affect companion animals, such wound and fracture healing or gastrointestinal reflux.

F) The category referred as “animals born in rest of world” is related to genetically altered rodent provided from USA Institutes for special projects.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

No particular change in trends in actual severities are reported.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Laboratory Animal Science accredited courses take place in Greece annually, which promote this principle.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

A significant proportion of other fish is reported in Greece for 2016. Greece is a leading country in Mediterranean fish production and significant research is carried out in this field compared to other MS. Sparus aurata and Dicentrarchus labrax are the leading species, with Argyrosomous regius and Seriola dumerili to follow. Procedures on fish include behavioural studies or drug testing, which cause stress to the animals and are classified as “mild”.

Rodents have been used for mouse development from epiblast derived cells in 2016, but not in an exceptional trend.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No such case reported for 2016.

Greece: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

23946

52.65%

Rats

2222

4.89%

Guinea-Pigs

13

0.03%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

491

1.08%

Cats

13

0.03%

Dogs

3

0.01%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

333

0.73%

Goats

Sheep

12

0.03%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

3

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

3200

7.04%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

130

0.29%

Other Fish

15117

33.24%

Cephalopods

Total

45483

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

45127

99.83%

Animals born in the EU but not at a registered breeder

30

0.07%

Animals born in rest of Europe

Animals born in rest of world

48

0.11%

Total

45205

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

1

100%

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

1

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

1

100%

Self-sustaining colony

Total

1

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

33690

74.07%

Translational and applied research

4514

9.92%

Regulatory use and Routine production

6630

14.58%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

649

1.43%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

45483

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

2377

7.06%

Cardiovascular Blood and Lymphatic System

2855

8.47%

Nervous System

1753

5.2%

Respiratory System

335

0.99%

Gastrointestinal System including Liver

915

2.72%

Musculoskeletal System

502

1.49%

Immune System

1300

3.86%

Urogenital/Reproductive System

97

0.29%

Sensory Organs (skin, eyes and ears)

1284

3.81%

Endocrine System/Metabolism

742

2.2%

Multisystemic

3075

9.13%

Ethology / Animal Behaviour /Animal Biology

14957

44.4%

Other basic research

3498

10.38%

Total

33690

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

1319

29.22%

Human Infectious Disorders

224

4.96%

Human Cardiovascular Disorders

385

8.53%

Human Nervous and Mental Disorders

526

11.65%

Human Respiratory Disorders

422

9.35%

Human Gastrointestinal Disorders including Liver

204

4.52%

Human Musculoskeletal Disorders

841

18.63%

Human Immune Disorders

135

2.99%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

67

1.48%

Human Endocrine/Metabolism Disorders

136

3.01%

Other Human Disorders

207

4.59%

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

48

1.06%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

4514

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

6630

100%

Total

6630

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Safety testing in food and feed area

6630

100%

Total

6630

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

6630

100%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

6630

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

6630

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

6630

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

45206

99.39%

Yes

277

0.61%

Total

45483

100.00%



Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

1873

4.12%

Mild [up to and including]

32156

70.7%

Moderate

8903

19.57%

Severe

2551

5.61%

Total

45483

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

45053

99.05%

Yes

430

0.95%

Total

45483

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

34912

76.76%

Genetically altered without a harmful phenotype

7683

16.89%

Genetically altered with a harmful phenotype

2888

6.35%

Total

45483

100.00%



Greece: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

A significant increase in the use of animals for the creation of new genetic lines is reported and can be attributed to the increase of funding by European research projects.

A significant increase in the number of animals undergone “non-recovery” procedures has been reported. This is proportional to the number of animals used for higher education of training for the acquisition, training of improvement of vocational skills.

A new user establishment was authorised in 2017, which performs research projects on the protection of natural environment in the interests of the health of welfare of humans and animals. This is a new category of purposes in Greece.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

A) A significant use of fish is depicted in Greek statistical data in 2016 compared to other MS. This is due to the fact that Greece is a Mediterranean country and has a number of user establishments dealing with studies on fish biology, behaviour/ethology and production methods of aquaculture species. Dicentrarchus labrax and Sparus aurata are the main species used. In user establishments, fishes are maintained under similar commercial production conditions, and most of the projects consist of variations in the rearing parameters (temperature, photoperiod, dissolved oxygen, tank size, feed type and frequency, rearing density, etc.) that may cause stress to the animals and are classified as “mild”.

B) A significant decrease in the use of domestic fowl is reported due to lack of relevant projects performed in 2017 by a user establishment.

C) Regarding the use of cephalopods (first time for Greece in 2017):

The application of the protocol had the objective to assess the sensitivity and immune response of O. vulgaris against common fish pathogens under different physicochemical water parameters (i.e. different temperatures). Animals are infected either intramuscularly or intravenously, hemolymph is collected for the assessment of immune stimulation and at the end of the experiment, organ samples are collected to assess immune responses and bacteria presence internally. All procedures are carried out under anesthesia, while organ sampling is performed after euthanasia with an overdose of anesthetic. In 2017, the protocol was applied once in 33 animals. From these, 9 individuals either died or used for the collection of samples and for 24 individuals, the protocol was characterized as mild. O. vulgaris were used by a newly authorised user establishment.

D) Regarding the use of animals for the protection of natural environment in the interests of the health or welfare of human beings or animals, that is recorded for the first time in 2017, these were used by a newly authorised user establishment.

E) It has to be noted that the use of various species differs among each year according to the protocols authorised and funding received by user establishments. Minor changing trends can be recorded.

F) It has to be noted that the use of animals for translational and applied research has increased by approximately 40% in total. This percentage in general differs among each year according to the protocols authorised and funding received by user establishments.

G) It has to be noted that the use of animals for various systems either for basic or translational and applied research varies among each year according to the nature of protocols chosen by researchers.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

A) Animals with “Non recovery” severity seem to have diminished due to a decrease in higher education trainings programs that are performed with the use of live animals in Greece.

B) The application of experimental protocols on teleosts by a newly authorised user establishment had the objective to assess either resistance of fish to fish pathogens or the efficacy of vaccines. These protocols were classified as severe because mortality is caused near to or more than > 70%. For 2017, gilthead sea bream and European sea bass were used.

C) A significant increase in the use of animals in translational/applied research for human cancer has been noted in 2017 compared to 2016 which has resulted in the relevant increase of the severe use of those animals. This can attributed to the increase of funding research programmes in this sector.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Laboratory animal science training courses are organised annually in Greece.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

A) A significant proportion of other fish is reported in Greece for 2017. Greece is a leading country in Mediterranean fish production and significant research is carried out in this field compared to other MS. Sparus aurata and Dicentrarchus labrax are the leading species, with Argyrosomous regius and Seriola dumerili to follow. Procedures on fish include behavioural studies or drug testing, which cause stress to the animals and are classified as “mild”.

B) A number of rodents have been reported under ‘Translational/ Applied research”: Other human disorders, as having been used in multisystemic protocols including arthritis and enteropathy.

C) A number of rodents have been reported for aging studies using “mild” procedures.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No such case reported for 2017.

Greece: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

25479

54.52%

Rats

2438

5.22%

Guinea-Pigs

6

0.01%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

213

0.46%

Cats

8

0.02%

Dogs

41

0.09%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

289

0.62%

Goats

Sheep

8

0.02%

Cattle

3

0.01%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

1

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

6

0.01%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

1859

3.98%

Other Fish

16346

34.98%

Cephalopods

33

0.07%

Total

46730

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

45596

98.55%

Animals born in the EU but not at a registered breeder

33

0.07%

Animals born in rest of Europe

Animals born in rest of world

640

1.38%

Total

46269

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

27573

59%

Translational and applied research

8058

17.24%

Regulatory use and Routine production

6887

14.74%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

3093

6.62%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1119

2.39%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

46730

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

923

3.35%

Cardiovascular Blood and Lymphatic System

1315

4.77%

Nervous System

1204

4.37%

Respiratory System

Gastrointestinal System including Liver

428

1.55%

Musculoskeletal System

520

1.89%

Immune System

2225

8.07%

Urogenital/Reproductive System

242

0.88%

Sensory Organs (skin, eyes and ears)

988

3.58%

Endocrine System/Metabolism

843

3.06%

Multisystemic

99

0.36%

Ethology / Animal Behaviour /Animal Biology

14686

53.26%

Other basic research

4100

14.87%

Total

27573

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

2487

30.86%

Human Infectious Disorders

271

3.36%

Human Cardiovascular Disorders

967

12%

Human Nervous and Mental Disorders

1372

17.03%

Human Respiratory Disorders

291

3.61%

Human Gastrointestinal Disorders including Liver

363

4.5%

Human Musculoskeletal Disorders

710

8.81%

Human Immune Disorders

200

2.48%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

381

4.73%

Human Endocrine/Metabolism Disorders

34

0.42%

Other Human Disorders

648

8.04%

Animal Diseases and Disorders

Animal Welfare

40

0.5%

Diagnosis of diseases

230

2.85%

Plant diseases

Non-regulatory toxicology and ecotoxicology

64

0.79%

Total

8058

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

6887

100%

Total

6887

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Pharmaco-dynamics (incl safety pharmacology)

10

0.15%

Safety testing in food and feed area

6877

99.85%

Total

6887

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

10

0.15%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

6877

99.85%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

6887

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

6887

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

6887

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

46269

99.01%

Yes

461

0.99%

Total

46730

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

3646

7.8%

Mild [up to and including]

29392

62.9%

Moderate

9198

19.68%

Severe

4494

9.62%

Total

46730

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

42770

91.53%

Yes

3960

8.47%

Total

46730

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

31622

67.67%

Genetically altered without a harmful phenotype

12982

27.78%

Genetically altered with a harmful phenotype

2126

4.55%

Total

46730

100.00%

Hungary

Hungary: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

The total number of animals used for experimental and other scientific purposes in 2015 was 195 603 which represents 2.7 % decrease compared to the same figure of 2014. The number of re-uses has been decreased by 56% (from 6584 to 2924).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The increase was 10.8% in the number of mice, 3.65% in case of rats, 23.22% for guinea-pigs and 29.08% in the case of rabbits. Both the number and the proportion of rodents increased since 2014 (hamsters and other rodents represents only a small percentage of rodents), the proportion of them is about 63% (it was 57% in 2014 and 61% in 2013).

The number of used birds is still very high (50 117), and the proportion of domestic fowls grew among them from 89.39% to 96.23% (mainly because of the decrease in the number of other poultry species).

The number of used cats was more than 4 times higher than in 2014 (60 compared to 14), in contrast the number of dogs decreased by 42% (from 859 to 495).

There was a 10% decrease in the number of pigs (in opposition to the growing tendency during the last few years). Notable changes can be observed also in the proportion of other farm animals (sheep, cattle), but their number is relatively low which could cause fluctuation.

The number of zebra fish and other fishes decreased by 83% and more than 25%. The number of amphibians also decreased by about 25% (form 8373 to 6286), but it is still high compared to the period between 2007 and 2012 (it was ranged between 340 and 1807). The number of reptiles is only 12 compared to 62 in 2014.

When analysed by the purposes of the use of animals a large decrease can be observed in the fundamental biological research segment (more than 47%), and the number of animals used in education has also decreased (by nearly 62%). On the other hand remarkable increase can be observed in applied and translational research (almost 28%) – which was a key reason for the increase in the number of used rodents –, in regulatory and routine production (16.59%), and also in the number of animals used for the preservation of species (more than 70%) and used for the protection of the natural environment (which is 133 times more than in 2014).

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The proportion of non-recoveries was dropped from 21.61% to 12.78%, the proportion of severe uses from 6.90% to 6.01%, and the moderate uses from 16.55% to 14.12%. On the other hand mild uses increased from 54.95% to 67.10%.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Due to the stringent national measures the use of non-human primates for scientific purposes has been replaced by other methods where possible and the number of them is very low in Hungary. The use of non-human primates occurs only when there is not any alternative method.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Xenopus spp., Rana temporaria or Rana pipiens were not used in 2015; therefore the ratio of other amphibians is 100%. High number of Bufo bufo (5400 individuals, 85.91% of all amphibians), and also Lissotriton vulgaris (526 individuals) and Rana dalmatina (360 individuals) used for the preservation of species and for the protection of the natural environment in the interest of the health or welfare of human beings or animals.

The ratio of other fish is 69.23% mainly due to the high number of Poecilia reticulata used in regulatory ecotoxicology tests (2250 individuals, 49.82% of other fish) and farm fish species (e.g. Cyprinus carpio).

The ratio of other category in routine production is 100% (it is worth to note that the total number of animals used for routine production is quite low, only 603 individuals, so a single project can greatly influence the ratio).

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Cases where the 'severe' classification is exceeded did not occur.

Hungary: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

84650

43.28%

Rats

35037

17.91%

Guinea-Pigs

4113

2.1%

Hamsters (Syrian)

1

0%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

36

0.02%

Rabbits

5256

2.69%

Cats

60

0.03%

Dogs

495

0.25%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

2884

1.47%

Goats

Sheep

110

0.06%

Cattle

20

0.01%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

3

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

48230

24.66%

Other birds

1887

0.96%

Reptiles

12

0.01%

Rana

Xenopus

Other Amphibians

6286

3.21%

Zebra fish

2007

1.03%

Other Fish

4516

2.31%

Cephalopods

Total

195603

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

174024

90.32%

Animals born in the EU but not at a registered breeder

15917

8.26%

Animals born in rest of Europe

2236

1.16%

Animals born in rest of world

499

0.26%

Total

192676

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

3

100%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

3

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

3

100%

Self-sustaining colony

Total

3

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

38544

19.71%

Translational and applied research

63815

32.62%

Regulatory use and Routine production

84310

43.1%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

6006

3.07%

Preservation of species

960

0.49%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1968

1.01%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

195603

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

5013

13.01%

Cardiovascular Blood and Lymphatic System

2813

7.3%

Nervous System

12887

33.43%

Respiratory System

299

0.78%

Gastrointestinal System including Liver

2069

5.37%

Musculoskeletal System

382

0.99%

Immune System

3075

7.98%

Urogenital/Reproductive System

2459

6.38%

Sensory Organs (skin, eyes and ears)

239

0.62%

Endocrine System/Metabolism

2249

5.83%

Multisystemic

2259

5.86%

Ethology / Animal Behaviour /Animal Biology

2443

6.34%

Other basic research

2357

6.12%

Total

38544

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

2223

3.48%

Human Infectious Disorders

228

0.36%

Human Cardiovascular Disorders

499

0.78%

Human Nervous and Mental Disorders

43979

68.92%

Human Respiratory Disorders

81

0.13%

Human Gastrointestinal Disorders including Liver

278

0.44%

Human Musculoskeletal Disorders

Human Immune Disorders

580

0.91%

Human Urogenital/Reproductive Disorders

179

0.28%

Human Sensory Organ Disorders (skin, eyes and ears)

74

0.12%

Human Endocrine/Metabolism Disorders

116

0.18%

Other Human Disorders

294

0.46%

Animal Diseases and Disorders

11335

17.76%

Animal Welfare

492

0.77%

Diagnosis of diseases

1981

3.1%

Plant diseases

Non-regulatory toxicology and ecotoxicology

1476

2.31%

Total

63815

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

49504

58.72%

Other efficacy and tolerance testing

192

0.23%

Toxicity and other safety testing including pharmacology

34011

40.34%

Routine production

603

0.72%

Total

84310

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

17400

35.15%

Pyrogenicity testing

952

1.92%

Batch potency testing

30891

62.4%

Other quality controls

261

0.53%

Total

49504

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

16836

49.5%

Skin irritation/corrosion

336

0.99%

Skin sensitisation

4800

14.11%

Eye irritation/corrosion

329

0.97%

Repeated dose toxicity

3705

10.89%

Carcinogenicity

Neurotoxicity

Phototoxicity

Safety testing in food and feed area

Genotoxicity

643

1.89%

Reproductive toxicity

1048

3.08%

Developmental toxicity

667

1.96%

Kinetics

486

1.43%

Pharmaco-dynamics (incl safety pharmacology)

392

1.15%

Ecotoxicity

3936

11.57%

Target animal safety

694

2.04%

Other toxicity/safety testing

139

0.41%

Total

34011

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

15320

91%

Other lethal methods

Non lethal methods

1516

9%

Total

16836

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

2226

60.08%

29 - 90 days

615

16.6%

> 90 days

864

23.32%

Total

3705

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3936

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

3936

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

603

100%

Total

603

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

25232

29.93%

Legislation on medicinal products for veterinary use and their residues

51951

61.62%

Medical devices legislation

30

0.04%

Industrial chemicals legislation

Plant protection product legislation

4664

5.53%

Biocides legislation

3

0%

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

180

0.21%

Cosmetics legislation

Other legislation

2250

2.67%

Total

84310

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

83159

98.63%

Legislation satisfying national requirements only [within EU]

310

0.37%

Legislation satisfying Non-EU requirements only

841

1%

Total

84310

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

192679

98.51%

Yes

2924

1.49%

Total

195603

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

24993

12.78%

Mild [up to and including]

131240

67.1%

Moderate

27617

14.12%

Severe

11753

6.01%

Total

195603

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

194120

99.24%

Yes

1483

0.76%

Total

195603

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

188601

96.42%

Genetically altered without a harmful phenotype

6574

3.36%

Genetically altered with a harmful phenotype

428

0.22%

Total

195603

100.00%



Hungary: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

The total number of animals used for experimental and other scientific purposes in 2016 was 170 075 which represents about 13% decrease compared to the same figure of 2015 (there was also a downward trend in the last few years). The number of re-uses has also been decreased by 15% (from 2924 to 2493).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The vast majority (92.39%) of used animals – as in previous years – were warm-blooded vertebrates. There was increase in the proportion of mammals (form 67.82% to 75.14%) and amphibians (from 3.21% to 4.79%), while the proportion of birds and fish decreased (the birds from 25.62% to 17.25% and the fish from 3.30% to 2.82%).

The proportion of rodents among mammals is about the same as last year. The increase was 10.63% in the number of rats and 23.85% in case of guinea-pigs. On the other hand there was an about 11% decrease in the number of mice. Hamsters and other rodents represent only a small percentage of rodents. The number of rabbits decreased by 35.65%.

The number of used cats was more than 4 times lower than in 2015 (14 compared to 60), in contrast the number of dogs increased by 27.27% (from 495 to 630). No non-human primate was used in 2016 (compared to the 3 Rhesus monkeys in 2015).

There was a 25.83% increase in the number of pigs. Notable decrease can be observed in the proportion of other farm animals (sheep, cattle), but their number is relatively low which could cause fluctuation.

There was an about 41% decrease in the number of used birds. The number of domestic fowl decreased by 43.39%, while the number of other birds increased by 8 %.

The number of other fishes decreased by 35%. The proportion of zebra fish is almost the same as in 2015. The number of other amphibians increased by 29.45% (form 6286 to 8137). The number of reptiles is only 2 compared to 12 in 2015.

When analysed by the purposes of the use of animals a large decrease can be observed in regulatory and routine production (about 25%) and in the number of animals used for the protection of the natural environment (nearly 85%). On the other hand remarkable increase can be observed in the number of animals used for the preservation of species (which is more than 5 times more than in 2015), used in education (more than 36%) and in the fundamental biological research segment (5.53%). The proportion of animals in applied and translational research is almost the same as in 2015.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The proportion of mild uses was dropped from 67.10% to 48.80%. On the other hand moderate uses increased from 14.12% to 23.98%, severe uses from 6.01% to 8.19% and non-recoveries from 12.78% to 19.03%.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Due to the stringent national measures the use of non-human primates for scientific purposes has been replaced by other methods where possible and the number of them is very low in Hungary. The use of non-human primates occurs only when there is not any alternative method.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Only 6 Rana temporaria or Rana pipiens were used in 2016; therefore the ratio of other amphibians is 99.93%. High number of Bufo bufo (4830 individuals, 59.31% of all amphibians) and Rana dalmatina (3270 individuals, 40.16% of all amphibians) were used.

The ratio of other fish is 61.11% mainly due to the high number of farm fish species (e.g. Cyprinus carpio, Oncorhynchus mykiss) and Poecilia reticulata used in regulatory ecotoxicology tests.

The ratio of other category in routine production is 45.15% (it is worth to note that the total number of animals used for routine production is quite low, only 846 individuals, so a single project can greatly influence the ratio).

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Cases where the 'severe' classification is exceeded did not occur.

Hungary: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

76079

44.73%

Rats

38762

22.79%

Guinea-Pigs

5094

3%

Hamsters (Syrian)

63

0.04%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

40

0.02%

Rabbits

3363

1.98%

Cats

14

0.01%

Dogs

630

0.37%

Ferrets

8

0%

Other carnivores

Horses, donkeys and cross-breeds

Pigs

3629

2.13%

Goats

Sheep

91

0.05%

Cattle

16

0.01%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

27304

16.05%

Other birds

2039

1.2%

Reptiles

2

0%

Rana

6

0%

Xenopus

Other Amphibians

8137

4.78%

Zebra fish

1866

1.1%

Other Fish

2932

1.72%

Cephalopods

Total

170075

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

147713

88.14%

Animals born in the EU but not at a registered breeder

19479

11.62%

Animals born in rest of Europe

40

0.02%

Animals born in rest of world

350

0.21%

Total

167582

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

40678

23.92%

Translational and applied research

57752

33.96%

Regulatory use and Routine production

62895

36.98%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

950

0.56%

Preservation of species

5112

3.01%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2688

1.58%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

170075

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

3669

9.02%

Cardiovascular Blood and Lymphatic System

2451

6.03%

Nervous System

15998

39.33%

Respiratory System

993

2.44%

Gastrointestinal System including Liver

3428

8.43%

Musculoskeletal System

663

1.63%

Immune System

3088

7.59%

Urogenital/Reproductive System

1759

4.32%

Sensory Organs (skin, eyes and ears)

721

1.77%

Endocrine System/Metabolism

2204

5.42%

Multisystemic

2112

5.19%

Ethology / Animal Behaviour /Animal Biology

1634

4.02%

Other basic research

1958

4.81%

Total

40678

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

3290

5.7%

Human Infectious Disorders

1367

2.37%

Human Cardiovascular Disorders

508

0.88%

Human Nervous and Mental Disorders

26418

45.74%

Human Respiratory Disorders

239

0.41%

Human Gastrointestinal Disorders including Liver

758

1.31%

Human Musculoskeletal Disorders

29

0.05%

Human Immune Disorders

354

0.61%

Human Urogenital/Reproductive Disorders

3

0.01%

Human Sensory Organ Disorders (skin, eyes and ears)

50

0.09%

Human Endocrine/Metabolism Disorders

Other Human Disorders

36

0.06%

Animal Diseases and Disorders

15687

27.16%

Animal Welfare

478

0.83%

Diagnosis of diseases

4509

7.81%

Plant diseases

Non-regulatory toxicology and ecotoxicology

4026

6.97%

Total

57752

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

25445

40.46%

Other efficacy and tolerance testing

70

0.11%

Toxicity and other safety testing including pharmacology

36534

58.09%

Routine production

846

1.35%

Total

62895

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

11247

44.2%

Pyrogenicity testing

646

2.54%

Batch potency testing

13252

52.08%

Other quality controls

300

1.18%

Total

25445

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

19234

52.65%

Skin irritation/corrosion

184

0.5%

Skin sensitisation

5438

14.88%

Eye irritation/corrosion

131

0.36%

Repeated dose toxicity

3804

10.41%

Carcinogenicity

Neurotoxicity

Phototoxicity

Safety testing in food and feed area

Genotoxicity

1272

3.48%

Reproductive toxicity

340

0.93%

Developmental toxicity

1656

4.53%

Kinetics

875

2.4%

Pharmaco-dynamics (incl safety pharmacology)

204

0.56%

Ecotoxicity

2555

6.99%

Target animal safety

130

0.36%

Other toxicity/safety testing

711

1.95%

Total

36534

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

16581

86.21%

Other lethal methods

Non lethal methods

2653

13.79%

Total

19234

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

466

12.25%

29 - 90 days

126

3.31%

> 90 days

3212

84.44%

Total

3804

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

2555

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

2555

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

114

13.48%

Monoclonal antibody by mouse ascites method

350

41.37%

Other product types

382

45.15%

Total

846

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

27171

43.2%

Legislation on medicinal products for veterinary use and their residues

31160

49.54%

Medical devices legislation

21

0.03%

Industrial chemicals legislation

2966

4.72%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

526

0.84%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

1051

1.67%

Total

62895

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

61739

98.16%

Legislation satisfying national requirements only [within EU]

723

1.15%

Legislation satisfying Non-EU requirements only

433

0.69%

Total

62895

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

167582

98.53%

Yes

2493

1.47%

Total

170075

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

32367

19.03%

Mild [up to and including]

82993

48.8%

Moderate

40784

23.98%

Severe

13931

8.19%

Total

170075

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

168864

99.29%

Yes

1211

0.71%

Total

170075

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

162097

95.31%

Genetically altered without a harmful phenotype

7170

4.22%

Genetically altered with a harmful phenotype

808

0.48%

Total

170075

100.00%



Hungary: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

The total number of animals used for experimental and other scientific purposes in 2017 was 141 183 which represents about 17% decrease compared to the same figure of 2016 (there was also a downward trend in the last few years). The number of re-uses has been increased by 300% (from 2493 to 7520).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The vast majority (97.58%) of used animals were warm-blooded vertebrates. There was increase in the proportion of mammals (form 75.14% to 78.28%) and birds (from 17.25% to 19.30%), while the proportion of amphibians and fish decreased (amphibians from 4.79% to 0.0% and the fish from 2.82% to 2.42%).

The proportion of rodents among mammals increased from 93.93% to 95.92%. There was 19% decrease in the number of mice and 30% in the number of rats. In case of guinea-pigs was 11% increase. On the other hand there was a dramatically increase at other rodents. Hamsters decreased to 0%. The number of rabbits decreased by 53%.

The number of used cats was a small increase (14 compared to 16). The number of dogs decreased by 36% (from 630 to 463). Two non-human primate was used in 2017 (compared to the 0 Rhesus monkeys in 2016).

There was 33.72% decrease in the number of pigs. Notable decrease can be observed in the proportion of other sheep, but increase in case of cattle, but their number is relatively low which could cause fluctuation.

The number of domestic fowl decreased by 7.82%, while the number of other birds increased by 2.2 %.

The proportion of zebra fish increased by 16.8% and other fish decreased by 59.95%. The number of other amphibians dramatically decreased to 0% (form 8137). The number of reptiles is 0 compared to 2 in 2016.

When analysed by the purposes of the use of animals a small increase can be observed in regulatory and routine production (about 6.3%) and in the number of animals used for the protection of the natural environment and preservation of species decreased to 0%. The proportion of basic research, animals in applied and translational research shows decrease than in 2016.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The proportion of mild uses was increased from 48.80% to 49.85%. and moderate uses also from 23.98% to 28.60%, severe uses from 8.19% to 12.76%. It means there was 30% increase in number of severe procedures. This increase was highly influented by two projects with animal diseases and disorders purpose. It contains 5071 Gallus gallus domesticus and 1224 Sus scrofa domesticus.

On the other hand non-recoveries decreased from 19.03% to 8.79%.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Due to the stringent national measures the use of non-human primates for scientific purposes has been replaced by other methods where possible and the number of them is very low in Hungary. The use of non-human primates occurs only when there is not any alternative method.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The number of other amphibians dramatically decreased from 8137 to 0 in 2017. The reason is there is an establishment, where in 2016 investigated Rana dalmatina, Bufo bufo, Lissortion vulgaris. There was mainly eggs collection at the natural habitat and after incubation investigated juvenils and natural predators. At the end of the project more than 3700 amphibians were released into their habitat. These projects were categorized into protection of the natural environment and preservation of species. It explains the dramatically decrease to 0 value in purpose category.

The number of used rabbits decreased by 53%. In 2016 there were projects a batch safety testing project with 1097 rabbits and a pyrogenicity testing with 606 rabbits. The reason for the 53% decrease is this 2 projects ended in 2016.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Cases where the 'severe' classification is exceeded did not occur.

Hungary: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

65876

46.8%

Rats

33946

24.12%

Guinea-Pigs

5765

4.1%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

1583

1.12%

Cats

16

0.01%

Dogs

463

0.33%

Ferrets

4

0%

Other carnivores

Horses, donkeys and cross-breeds

Pigs

2405

1.71%

Goats

Sheep

Cattle

33

0.02%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

2

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

25169

17.88%

Other birds

2084

1.48%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

2243

1.59%

Other Fish

1174

0.83%

Cephalopods

Total

140763

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

126683

95.08%

Animals born in the EU but not at a registered breeder

5062

3.8%

Animals born in rest of Europe

1187

0.89%

Animals born in rest of world

309

0.23%

Total

133241

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

2

100%

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

2

100.00%



Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

2

100%

Self-sustaining colony

Total

2

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

38539

27.38%

Translational and applied research

41847

29.73%

Regulatory use and Routine production

58007

41.21%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2370

1.68%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

140763

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

3346

8.68%

Cardiovascular Blood and Lymphatic System

3406

8.84%

Nervous System

16498

42.81%

Respiratory System

718

1.86%

Gastrointestinal System including Liver

1865

4.84%

Musculoskeletal System

189

0.49%

Immune System

4412

11.45%

Urogenital/Reproductive System

1678

4.35%

Sensory Organs (skin, eyes and ears)

488

1.27%

Endocrine System/Metabolism

1417

3.68%

Multisystemic

2369

6.15%

Ethology / Animal Behaviour /Animal Biology

526

1.36%

Other basic research

1627

4.22%

Total

38539

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

4919

11.75%

Human Infectious Disorders

581

1.39%

Human Cardiovascular Disorders

293

0.7%

Human Nervous and Mental Disorders

20172

48.2%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

211

0.5%

Human Musculoskeletal Disorders

79

0.19%

Human Immune Disorders

89

0.21%

Human Urogenital/Reproductive Disorders

8

0.02%

Human Sensory Organ Disorders (skin, eyes and ears)

40

0.1%

Human Endocrine/Metabolism Disorders

Other Human Disorders

224

0.54%

Animal Diseases and Disorders

9410

22.49%

Animal Welfare

4573

10.93%

Diagnosis of diseases

788

1.88%

Plant diseases

Non-regulatory toxicology and ecotoxicology

460

1.1%

Total

41847

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

27156

46.82%

Other efficacy and tolerance testing

329

0.57%

Toxicity and other safety testing including pharmacology

29813

51.4%

Routine production

709

1.22%

Total

58007

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

10102

37.2%

Pyrogenicity testing

29

0.11%

Batch potency testing

16682

61.43%

Other quality controls

343

1.26%

Total

27156

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

17639

59.17%

Skin irritation/corrosion

293

0.98%

Skin sensitisation

4629

15.53%

Eye irritation/corrosion

137

0.46%

Repeated dose toxicity

1125

3.77%

Carcinogenicity

40

0.13%

Genotoxicity

562

1.89%

Reproductive toxicity

833

2.79%

Developmental toxicity

1286

4.31%

Neurotoxicity

Phototoxicity

Safety testing in food and feed area

Target animal safety

Kinetics

1207

4.05%

Pharmaco-dynamics (incl safety pharmacology)

569

1.91%

Ecotoxicity

1028

3.45%

Other toxicity/safety testing

465

1.56%

Total

29813

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

14255

80.82%

Other lethal methods

Non lethal methods

3384

19.18%

Total

17639

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

438

38.93%

29 - 90 days

75

6.67%

> 90 days

612

54.4%

Total

1125

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

1028

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

1028

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

40

5.64%

Monoclonal antibody by mouse ascites method

157

22.14%

Other product types

512

72.21%

Total

709

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

25062

43.21%

Legislation on medicinal products for veterinary use and their residues

28770

49.6%

Medical devices legislation

516

0.89%

Industrial chemicals legislation

834

1.44%

Plant protection product legislation

2167

3.74%

Biocides legislation

Food legislation including food contact material

461

0.79%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

197

0.34%

Total

58007

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

56731

97.8%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

1276

2.2%

Total

58007

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

133243

94.66%

Yes

7520

5.34%

Total

140763

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

12410

8.82%

Mild [up to and including]

70383

50%

Moderate

39954

28.38%

Severe

18016

12.8%

Total

140763

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

139882

99.37%

Yes

881

0.63%

Total

140763

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

132229

93.94%

Genetically altered without a harmful phenotype

7898

5.61%

Genetically altered with a harmful phenotype

636

0.45%

Total

140763

100.00%



Ireland

Ireland: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

·There was a 1% increase in animal uses from 2014 to 2015.

·There was a 31% drop in procedures reported as severe from 2014 to 2015.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

·Although the majority of animals are still used for regulatory purposes, basic research overtook translational research as the second most common project purpose. The increase in numbers used for basic research went from 34,512 in 2014 to 42,347 in 2015, an increase of 23%. The species that account for most of this increase in basic research were cattle, pigs and fish, in particular cattle of which there were 7,246 uses in 2015 compared to 2,712 uses in 2014. A significant amount of agricultural research is performed in Ireland, and much of this is reported (based on our advice) as ‘Basic research – ethology/animal behaviour/animal biology’ because it involves feeding trials and investigation into reproductive efficiency. For example, over 2000 cattle were used for a single epidemiological study of the key factors affecting reproductive efficiency of beef cattle herds. This could potentially also be considered as translational research but it doesn’t quite fit into the categories ‘animal diseases and disorders’ nor ‘animal welfare’.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

·Non-recovery: 1% (2014) to 2% (2015)

·Mild: 28% (2014) to 50% (2015)

·Moderate: 32% (2014) to 22% (2015)

·Severe: 40% (2014) to 27% (2015)

·Overall there was a drop in severe and moderate procedures and an increase in mild and non-recovery procedures. The reason for this is unknown; but we would be cautious about over-interpreting this as it may be due to people becoming more accustomed to recording actual severity properly, rather than recording what they were prospectively authorised for.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

·In 2015 we made it mandatory for humane endpoints to be implemented for LD50 tests in Ireland; however progress is slow re-validating the different assays so this has not impacted on the statistics, and the eventual impact on the statistics will probably be minimal, as animals will have already reached a ‘severe’ severity when they are culled. We have also been in frequent contact with pharmaceutical companies producing botulinum toxin products in relation to the replacement of animal tests with non-animal assays so we would hope to see a drop in LD50 testing over the next few years when more of these cell-based assays become available for use.

·In 2015 we also contacted all pharmaceutical companies using rabbit pyrogen testing for their products in Ireland requesting they switch to an alternative or provide robust scientific justification for the use of an animal test. This communication has not had a major impact on the statistics for 2015 with 570 rabbits used for pyrogen testing in 2015 (versus 597 in 2014) but we would hope that the positive impact of this dialogue becomes evident in the 2016 statistics..

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

·We did not have many animals reported under the ‘other’ category because we combed through each submission and made sure that if there was an appropriate pre-existing category available, that it was chosen. However, it should be noted that as previously mentioned, a lot of the agricultural research in Ireland could be considered translational, yet there is no appropriate translational category. Animal diseases and disorders is not accurate because these are healthy animals and animal welfare is not appropriate either as most of the research is not to benefit the animal, but to improve yields (e.g. milk, meat) and efficiency and therefore benefit the farmer and the economy. Perhaps there could be a translational category appropriate for this type of work?

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

·The severe classification was not exceeded in 2015.

Ireland: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

190585

83.47%

Rats

9876

4.33%

Guinea-Pigs

1929

0.84%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

2490

1.09%

Cats

164

0.07%

Dogs

587

0.26%

Ferrets

621

0.27%

Other carnivores

Horses, donkeys and cross-breeds

127

0.06%

Pigs

2372

1.04%

Goats

71

0.03%

Sheep

1112

0.49%

Cattle

11119

4.87%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

20

0.01%

Domestic fowl

113

0.05%

Other birds

572

0.25%

Reptiles

Rana

Xenopus

420

0.18%

Other Amphibians

Zebra fish

1489

0.65%

Other Fish

4672

2.05%

Cephalopods

Total

228339

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

209587

92.77%

Animals born in the EU but not at a registered breeder

15014

6.65%

Animals born in rest of Europe

129

0.06%

Animals born in rest of world

1195

0.53%

Total

225925

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

42179

18.47%

Translational and applied research

22516

9.86%

Regulatory use and Routine production

157872

69.14%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

815

0.36%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

389

0.17%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

4568

2%

Total

228339

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

1061

2.52%

Cardiovascular Blood and Lymphatic System

429

1.02%

Nervous System

8542

20.25%

Respiratory System

473

1.12%

Gastrointestinal System including Liver

2943

6.98%

Musculoskeletal System

278

0.66%

Immune System

13168

31.22%

Urogenital/Reproductive System

2378

5.64%

Sensory Organs (skin, eyes and ears)

1543

3.66%

Endocrine System/Metabolism

578

1.37%

Multisystemic

1601

3.8%

Ethology / Animal Behaviour /Animal Biology

9185

21.78%

Other basic research

Total

42179

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

1209

5.37%

Human Infectious Disorders

1413

6.28%

Human Cardiovascular Disorders

1002

4.45%

Human Nervous and Mental Disorders

4173

18.53%

Human Respiratory Disorders

562

2.5%

Human Gastrointestinal Disorders including Liver

300

1.33%

Human Musculoskeletal Disorders

1776

7.89%

Human Immune Disorders

540

2.4%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

1133

5.03%

Human Endocrine/Metabolism Disorders

139

0.62%

Other Human Disorders

Animal Diseases and Disorders

9656

42.89%

Animal Welfare

240

1.07%

Diagnosis of diseases

373

1.66%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

22516

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

156621

99.21%

Other efficacy and tolerance testing

640

0.41%

Toxicity and other safety testing including pharmacology

611

0.39%

Routine production

Total

157872

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

6021

3.84%

Pyrogenicity testing

570

0.36%

Batch potency testing

150030

95.79%

Other quality controls

Total

156621

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Ecotoxicity

559

91.49%

Target animal safety

52

8.51%

Total

611

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

559

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

559

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

155248

98.34%

Legislation on medicinal products for veterinary use and their residues

2047

1.3%

Medical devices legislation

18

0.01%

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

559

0.35%

Total

157872

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

157872

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

157872

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

225925

98.94%

Yes

2414

1.06%

Total

228339

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

3020

1.32%

Mild [up to and including]

113368

49.65%

Moderate

49705

21.77%

Severe

62246

27.26%

Total

228339

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

226472

99.18%

Yes

1867

0.82%

Total

228339

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

212262

92.96%

Genetically altered without a harmful phenotype

15476

6.78%

Genetically altered with a harmful phenotype

601

0.26%

Total

228339

100.00%



Ireland: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

·There was a 1% decrease on number of uses reported from 2015.

·There was 21% drop in reported reuse.

·Basic research has reduced by 33% and Translational and applied has increased by 14%.

·The number of uses for Maintenance of colonies of established GA animals not used in other procedures has dropped by 80%.

It is difficult to say with certainty what the reasons for these changes are.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

As in previous years, in 2016 mice were still the most commonly used species representing 85% of overall animal use. Significant changes in species from 2015 to 2016 include the drop in the number of uses of cattle by 46% and the increased use of ‘other fish’ (e.g. salmon, eels and trout) by 125%. The decrease in cattle use relates to the completion of a particularly large country-wide cattle study in 2015. The increase in the use of ‘other fish’ relates to the increased tracking of eel and salmon stocks in Ireland (using tagging methods) due to concerns regarding their conservation status.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

·Majority of procedures are still mild (44%)

·Moderate procedures have increased from 22 to 26% of use

·Severe procedures have increased from 27 to 29%

·Non-recovery procedures have dropped from 2% to 1%

Clear trends in relation to severity may take a few more years to emerge as users are still becoming acquainted with the new reporting requirements.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The HPRA has made specific proactive efforts in communicating with contract research organisations and pharmaceutical companies in relation to the introduction of non-animal alternatives for regulatory tests, e.g. rabbit pyrogen and LD50 testing, as well as the introduction of earlier humane endpoints (for LD50 testing). However, due to the complex and protracted process involved in gaining regulatory acceptance and approval for such changes to regulatory testing protocols, an impact on the annual statistics is not expected until the 2018 report at the earliest.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The category ‘other fish’ represented 5% of animal use. This primarily represents wild fish being studied for conservation projects. For example, European eels are a critically endangered species and Irish salmon stocks are critically low, so monitoring projects are required to improve the survival of these species

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

This was not exceeded nor was exemption granted at all during 2016.

Ireland: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

192121

84.66%

Rats

9892

4.36%

Guinea-Pigs

964

0.42%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

1228

0.54%

Cats

271

0.12%

Dogs

356

0.16%

Ferrets

404

0.18%

Other carnivores

Horses, donkeys and cross-breeds

204

0.09%

Pigs

1209

0.53%

Goats

30

0.01%

Sheep

1323

0.58%

Cattle

6044

2.66%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

196

0.09%

Other birds

674

0.3%

Reptiles

Rana

Xenopus

60

0.03%

Other Amphibians

Zebra fish

1439

0.63%

Other Fish

10519

4.64%

Cephalopods

Total

226934

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

209821

93.28%

Animals born in the EU but not at a registered breeder

14166

6.3%

Animals born in rest of Europe

455

0.2%

Animals born in rest of world

487

0.22%

Total

224929

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

28340

12.49%

Translational and applied research

26230

11.56%

Regulatory use and Routine production

170976

75.34%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

235

0.1%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

250

0.11%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

903

0.4%

Total

226934

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

213

0.75%

Cardiovascular Blood and Lymphatic System

803

2.83%

Nervous System

3876

13.68%

Respiratory System

1081

3.81%

Gastrointestinal System including Liver

2388

8.43%

Musculoskeletal System

68

0.24%

Immune System

6667

23.53%

Urogenital/Reproductive System

4

0.01%

Sensory Organs (skin, eyes and ears)

553

1.95%

Endocrine System/Metabolism

101

0.36%

Multisystemic

717

2.53%

Ethology / Animal Behaviour /Animal Biology

11868

41.88%

Other basic research

1

0%

Total

28340

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

1566

5.97%

Human Infectious Disorders

947

3.61%

Human Cardiovascular Disorders

2086

7.95%

Human Nervous and Mental Disorders

9308

35.49%

Human Respiratory Disorders

80

0.3%

Human Gastrointestinal Disorders including Liver

369

1.41%

Human Musculoskeletal Disorders

538

2.05%

Human Immune Disorders

1130

4.31%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

1553

5.92%

Human Endocrine/Metabolism Disorders

584

2.23%

Other Human Disorders

Animal Diseases and Disorders

7691

29.32%

Animal Welfare

360

1.37%

Diagnosis of diseases

18

0.07%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

26230

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

169714

99.26%

Other efficacy and tolerance testing

Routine production

Toxicity and other safety testing including pharmacology

1262

0.74%

Total

170976

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1630

0.96%

Pyrogenicity testing

506

0.3%

Batch potency testing

167549

98.72%

Other quality controls

29

0.02%

Total

169714

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Kinetics

12

0.95%

Pharmaco-dynamics (incl safety pharmacology)

30

2.38%

Ecotoxicity

1180

93.5%

Target animal safety

40

3.17%

Total

1262

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

1180

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

1180

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

167227

97.81%

Legislation on medicinal products for veterinary use and their residues

2540

1.49%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

1209

0.71%

Total

170976

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

139897

81.82%

Legislation satisfying national requirements only [within EU]

29

0.02%

Legislation satisfying Non-EU requirements only

31050

18.16%

Total

170976

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

224929

99.12%

Yes

2005

0.88%

Total

226934

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

2357

1.04%

Mild [up to and including]

99442

43.82%

Moderate

58832

25.92%

Severe

66303

29.22%

Total

226934

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

225555

99.39%

Yes

1379

0.61%

Total

226934

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

216565

95.43%

Genetically altered without a harmful phenotype

8360

3.68%

Genetically altered with a harmful phenotype

2009

0.89%

Total

226934

100.00%



Ireland: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

·There was a 7% increase in animal use from the previous year (2016)

·This increase is accounted for by an increase in regulatory testing which is 80% of all testing.

·The use of cattle has dropped by 46% from the previous year, cats have dropped by 100% and dogs by 75%.

·There was a 67% decrease on reuse from the previous year.

·Basic research has dropped by 70% and Translational and Applied research has increased by 14%.

·There is a 28% drop in number of uses reported for ‘Maintenance of colonies of established GA animals not used in other procedures’.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

·The 7% increase in animal numbers is due to increased regulatory testing, largely due to increased batch potency testing. The main reason for this was a breakdown of a non-animal alternative test, resulting in increased animal testing. Another smaller proportion of this increase was due to the use of additional animals for the validation of humane endpoints for batch potency testing.

·The reduction in cattle was due to the completion of a very large country-wide agricultural project. The reduction in dogs and cats was due to the closure of a dog and cat facility.

·The drop in basic research and increase in translational is not likely due to a true change in the type of research being conducted, but likely more accurate reporting.

·The reason for the drop in uses reported for ‘maintenance of colonies of established GA animals not used in other procedures’ is not known, but could be due to more efficient GA breeding.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

There was a very slight increase in mild procedures (44 to 47%) and a slight decrease in moderate procedures (26 to 23%) but otherwise the proportions remained the same.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

·We focused a lot of efforts in ensuring that there is a move to non-animal alternatives for batch potency testing; however this is not reflected in the figures in 2017, but it is expected that it will be reflected in the 2018 figures on. For the animals that still must be used for this type of testing, we have also required the establishment to work on implementing humane endpoints for these tests. This should, over time, reduce the animals in the ‘severe’ actual severity category, but this is not yet reflected in the figures.

·We have also put efforts into ensuring that rabbit pyrogen testing is only carried out where justified, by contacting the pharmaceutical companies that employ this type of testing. Since 2014 there has been a 48% reduction in this type of testing.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

There was no significant use of the ‘other’ categories at all. With regards to species, ‘other fish’ account for 4% of animal use and ‘other birds’ less than 1%. These relates to studies of wild animals, such as tagging and conservation projects.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

This was not exceeded during 2017.

Ireland: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

206908

85.39%

Rats

16858

6.96%

Guinea-Pigs

518

0.21%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

400

0.17%

Cats

Dogs

89

0.04%

Ferrets

442

0.18%

Other carnivores

Horses, donkeys and cross-breeds

60

0.02%

Pigs

1547

0.64%

Goats

11

0%

Sheep

1321

0.55%

Cattle

3244

1.34%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

40

0.02%

Other birds

823

0.34%

Reptiles

Rana

Xenopus

18

0.01%

Other Amphibians

Zebra fish

236

0.1%

Other Fish

9787

4.04%

Cephalopods

Total

242302

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

227994

94.36%

Animals born in the EU but not at a registered breeder

13065

5.41%

Animals born in rest of Europe

121

0.05%

Animals born in rest of world

447

0.18%

Total

241627

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

8558

3.53%

Translational and applied research

29815

12.3%

Regulatory use and Routine production

194816

80.4%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

8366

3.45%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

274

0.11%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

473

0.2%

Total

242302

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

391

4.57%

Cardiovascular Blood and Lymphatic System

5

0.06%

Nervous System

2068

24.16%

Respiratory System

724

8.46%

Gastrointestinal System including Liver

1111

12.98%

Musculoskeletal System

192

2.24%

Immune System

991

11.58%

Urogenital/Reproductive System

238

2.78%

Sensory Organs (skin, eyes and ears)

54

0.63%

Endocrine System/Metabolism

139

1.62%

Multisystemic

6

0.07%

Ethology / Animal Behaviour /Animal Biology

2635

30.79%

Other basic research

4

0.05%

Total

8558

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

754

2.53%

Human Infectious Disorders

780

2.62%

Human Cardiovascular Disorders

1195

4.01%

Human Nervous and Mental Disorders

9381

31.46%

Human Respiratory Disorders

277

0.93%

Human Gastrointestinal Disorders including Liver

1114

3.74%

Human Musculoskeletal Disorders

747

2.51%

Human Immune Disorders

8230

27.6%

Human Urogenital/Reproductive Disorders

50

0.17%

Human Sensory Organ Disorders (skin, eyes and ears)

2057

6.9%

Human Endocrine/Metabolism Disorders

444

1.49%

Other Human Disorders

Animal Diseases and Disorders

2115

7.09%

Animal Welfare

2553

8.56%

Diagnosis of diseases

118

0.4%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

29815

100.00%



Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

194247

99.71%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

540

0.28%

Routine production

29

0.01%

Total

194816

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1920

0.99%

Pyrogenicity testing

312

0.16%

Batch potency testing

192015

98.85%

Other quality controls

Total

194247

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Ecotoxicity

500

92.59%

Target animal safety

40

7.41%

Total

540

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

500

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

500

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

29

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

29

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

185727

95.33%

Legislation on medicinal products for veterinary use and their residues

8589

4.41%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

500

0.26%

Total

194816

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

194784

99.98%

Legislation satisfying national requirements only [within EU]

32

0.02%

Legislation satisfying Non-EU requirements only

Total

194816

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

241627

99.72%

Yes

675

0.28%

Total

242302

100.00%



Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

2283

0.94%

Mild [up to and including]

114261

47.16%

Moderate

55162

22.77%

Severe

70596

29.14%

Total

242302

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

241716

99.76%

Yes

586

0.24%

Total

242302

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

234806

96.91%

Genetically altered without a harmful phenotype

5737

2.37%

Genetically altered with a harmful phenotype

1759

0.73%

Total

242302

100.00%



Italy

Italy: Narrative 2015

1.General information on any changes in trends observed since the previous reporting period.

In 2015, the total number of animals used in testing was 581,935, the first time this figure had fallen below 600,000. In general, the decrease in 2015 as compared to the previous year reflects the downward trend in the total number of animals used in testing, which has consistently remained below the one million mark since 1999.

In 2015, rodents and rabbits accounted for 91.19% of the animal species used. Within these species, there was an increase in the number of rats, rabbits and ‘other rodents’ used, while on the other hand there was a marked decrease from 485,820 to 373,483 in the number of mice used.

On the whole there has been a decrease in the use of other animal species, except for a slight increase as regards domestic fowl (from 28,215 in 2014 to 30,984 in 2015).

The total number of animals used went from 691,666 in 2014 to 581,935 in 2015, a percentage decrease of -15.86%. (See Table 1)

Table 1

Animal species

2014

% of the 2014 total

2015

% of the 2015 total

DIFFERENCE IN THE NUMBER OF ANIMALS

% DIFFERENCE 2014 / 2015

Rodents and rabbits

639,914

92.52

530,677

91.19

-109,237

-17.07

Other animal species

51,752

7.48

51,258

8.81

-494

-0.95

Total (all species)

691,666

100.00

581,935

100.00

-109,737

-15.86

2.Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

37.26% of the animals were used in basic biological studies.

24.92% of the animals were used in translational or applied research.

36.07% of the animals were used for regulatory use and routine production.

1.75% of the animals were used for other purposes.

No animals were used for forensic enquiries.

Table 2

Purpose of studies

2014

%

2015

%

% DIFFERENCE

Basic research

41.84

37.26

-4.58

Translational research

31.77

24.92

-6.85

Regulatory testing

25.45

36.07

10.62

Other

0.94

1.75

0.81

2015 saw an increase in the number of animals used for regulatory testing, while there was a decrease in the number of animals used for both basic research and translational research and a very slight increase for other purposes (see Table 2).

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

Data collection on the level of suffering felt by animals was recorded for the second time in 2015. A comparison between 2014 and 2015 shows that more than 47% of the animals experienced a ‘mild’ level of suffering, followed by 39% of animals with ‘moderate’ suffering, with neither the ‘non-recovery’ nor ‘severe’ suffering levels exceeding 7% (see Table 3).

Table 3

Suffering level / Year

Non-recovery

Mild (up to and including)

Moderate

Severe

2014

4.89

49.09

42.90

3.12

2015

6.16

47.58

39.44

6.82

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impact on statistics if any.

Legislative Decree No 26/2014, which transposes the European Directive, designated the laboratory of the cell substrates and cellular immunology department of the Lombardy and Emilia-Romagna Animal Disease Prevention Institute as the single contact point charged with providing advice on the suitability and regulatory appropriateness of alternative approaches proposed for validation studies.

That Decree earmarks funding for the development and validation of alternative methods and for staff training. This funding is €1 million annually for the 2014-2016 period, broken down as follows:

§50% to be paid to the regions and autonomous provinces to finance training and refresher courses for staff of authorised establishments;

§50% to be paid to Animal Disease Prevention Institutes for research and development of alternative methods.

Monies from levying the new State administrative fines (see Article 40(25)) are also allocated to the development and validation of alternative methods.

Also worth noting is the work of the Animal Welfare Bodies (Organismi Preposti al Benessere Animale (OPBAs)) under Article 25 of Legislative Decree No 26/2014. OPBAs are required to issue a reasoned opinion on research projects that are to be submitted for ministerial authorisation, verifying the correct application of the Three Rs principle and assessing the possibility of replacing one or more procedures with alternative methods and, where possible, also reducing the number of animals used.

As far as staff training is concerned, various conferences, workshops and courses were organised by the National Reference Centre for Animal Welfare in Brescia, universities and other research institutes. The Ministry of Health sends its own experts as lecturers to such training events.

The Ministry provided training at no fewer than ten training courses in 2015.

5.Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

Nothing to report.

6.Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

There were no cases in which the ‘severe’ classification was exceeded.

Italy: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

373666

63.69%

Rats

130972

22.32%

Guinea-Pigs

16668

2.84%

Hamsters (Syrian)

488

0.08%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

494

0.08%

Rabbits

9775

1.67%

Cats

Dogs

601

0.1%

Ferrets

14

0%

Other carnivores

Horses, donkeys and cross-breeds

Pigs

1746

0.3%

Goats

4

0%

Sheep

235

0.04%

Cattle

733

0.12%

Prosimians

Marmoset and tamarins

3

0%

Cynomolgus monkey

278

0.05%

Rhesus monkey

4

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

8

0%

Other species of New World Monkeys (Ceboidea)

24

0%

Apes

Other Mammals

16

0%

Domestic fowl

33020

5.63%

Other birds

750

0.13%

Reptiles

100

0.02%

Rana

Xenopus

422

0.07%

Other Amphibians

7

0%

Zebra fish

11331

1.93%

Other Fish

5328

0.91%

Cephalopods

12

0%

Total

586699

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

544052

93.53%

Animals born in the EU but not at a registered breeder

35311

6.07%

Animals born in rest of Europe

1167

0.2%

Animals born in rest of world

1181

0.2%

Total

581711

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

4

1.79%

Animals born in rest of Europe

Animals born in Asia

112

50%

Animals born in America

Animals born in Africa

108

48.21%

Animals born elsewhere

Total

224

100.00%



Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

54

24.11%

F2 or greater

169

75.45%

Self-sustaining colony

1

0.45%

Total

224

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

218615

37.26%

Translational and applied research

146213

24.92%

Regulatory use and Routine production

211615

36.07%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

76

0.01%

Preservation of species

228

0.04%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1042

0.18%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

8910

1.52%

Total

586699

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

61958

28.34%

Cardiovascular Blood and Lymphatic System

9112

4.17%

Nervous System

83400

38.15%

Respiratory System

4470

2.04%

Gastrointestinal System including Liver

7690

3.52%

Musculoskeletal System

5485

2.51%

Immune System

22940

10.49%

Urogenital/Reproductive System

2015

0.92%

Sensory Organs (skin, eyes and ears)

1556

0.71%

Endocrine System/Metabolism

4640

2.12%

Multisystemic

5293

2.42%

Ethology / Animal Behaviour /Animal Biology

7120

3.26%

Other basic research

2936

1.34%

Total

218615

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

40751

27.87%

Human Infectious Disorders

17960

12.28%

Human Cardiovascular Disorders

2606

1.78%

Human Nervous and Mental Disorders

21148

14.46%

Human Respiratory Disorders

17944

12.27%

Human Gastrointestinal Disorders including Liver

2428

1.66%

Human Musculoskeletal Disorders

2809

1.92%

Human Immune Disorders

6644

4.54%

Human Urogenital/Reproductive Disorders

2842

1.94%

Human Sensory Organ Disorders (skin, eyes and ears)

1908

1.3%

Human Endocrine/Metabolism Disorders

7589

5.19%

Other Human Disorders

3820

2.61%

Animal Diseases and Disorders

365

0.25%

Animal Welfare

466

0.32%

Diagnosis of diseases

16369

11.2%

Plant diseases

Non-regulatory toxicology and ecotoxicology

564

0.39%

Total

146213

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

108737

51.38%

Other efficacy and tolerance testing

36979

17.47%

Toxicity and other safety testing including pharmacology

62965

29.75%

Routine production

2934

1.39%

Total

211615

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

26087

23.99%

Pyrogenicity testing

4007

3.69%

Batch potency testing

75036

69.01%

Other quality controls

3607

3.32%

Total

108737

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

15574

24.73%

Skin irritation/corrosion

583

0.93%

Skin sensitisation

10312

16.38%

Eye irritation/corrosion

54

0.09%

Repeated dose toxicity

8137

12.92%

Carcinogenicity

873

1.39%

Genotoxicity

378

0.6%

Reproductive toxicity

6583

10.46%

Developmental toxicity

4162

6.61%

Neurotoxicity

200

0.32%

Kinetics

5513

8.76%

Pharmaco-dynamics (incl safety pharmacology)

504

0.8%

Phototoxicity

164

0.26%

Ecotoxicity

3985

6.33%

Safety testing in food and feed area

4970

7.89%

Target animal safety

196

0.31%

Other toxicity/safety testing

777

1.23%

Total

62965

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

6296

40.43%

Other lethal methods

120

0.77%

Non lethal methods

9158

58.8%

Total

15574

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

4350

53.46%

29 - 90 days

2841

34.91%

> 90 days

946

11.63%

Total

8137

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3319

83.29%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

666

16.71%

Total

3985

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

1115

38%

Monoclonal antibody by mouse ascites method

1520

51.81%

Other product types

299

10.19%

Total

2934

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

133861

63.26%

Legislation on medicinal products for veterinary use and their residues

31907

15.08%

Medical devices legislation

16980

8.02%

Industrial chemicals legislation

8704

4.11%

Plant protection product legislation

734

0.35%

Biocides legislation

1749

0.83%

Food legislation including food contact material

11973

5.66%

Feed legislation including legislation for the safety of target animals, workers and environment

706

0.33%

Cosmetics legislation

Other legislation

5001

2.36%

Total

211615

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

204055

96.43%

Legislation satisfying national requirements only [within EU]

2085

0.99%

Legislation satisfying Non-EU requirements only

5475

2.59%

Total

211615

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

581935

99.19%

Yes

4764

0.81%

Total

586699

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

36159

6.16%

Mild [up to and including]

279151

47.58%

Moderate

231395

39.44%

Severe

39994

6.82%

Total

586699

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

582552

99.29%

Yes

4147

0.71%

Total

586699

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

463538

79.01%

Genetically altered without a harmful phenotype

110917

18.91%

Genetically altered with a harmful phenotype

12244

2.09%

Total

586699

100.00%



Italy: Narrative 2016

Introduction

The data for Italy for 2016 are from the Ministry of Health – Directorate-General for Animal Health and Veterinary Medicines – Office 6 – Animal Welfare. They were collected via the National Electronic Database and, after suitability testing, were sent to the European Commission through the DECLARE platform.

1. General information on any changes in trends observed since the previous reporting period.

In 2016, the total number of animals used in testing was 607,097, i.e. slightly more than 600,000. This was lower than in 2014 (691,666 animals; -12.23%) and slightly higher than in 2015 (581,935; +4.32%) (see Figure 1). In any case, the data confirm the downward trend in the total number of animals used in testing, which has remained below the one million mark since 1999.

Figure 1

Translation of legend: Total number of animals used in Italy 2014-2016

In 2016, rodents and rabbits accounted for 90.36% of the animal species used. Within these species, there was an increase in the number of mice and rabbits as compared to 2015, while the use of rats decreased slightly.

For other animal species – which, in 2016, accounted for 9.64% of the total – there was an increase in the use of domestic fowl, fish (zebrafish) and amphibians (Xenopus). (See Table 1)

Table 1

Animal species

2014

% of the 2014 total

2015

% of the 2015 total

2016

% of the 2016 total

DIFFERENCE IN THE NUMBER OF ANIMALS 2014 / 2016

% DIFFERENCE 2014 / 2016

Rodents and rabbits

639,914

92.52

530,677

91.19

548,578

90.36

-91,336

-14.27

Other animal species

51,752

7.48

51,258

8.81

58,519

9.64

6,767

13.07

Total (all species)

691,666

100.00

581,935

100.00

607,097

100.00

-84,569

-12.23

2. Information on significant increase or decreases in use animals in any of the specific areas and analysis of the reasons thereof.

35.42% of the animals were used in basic biological studies.

26.54% were used in translational or applied research.

37.11% were used for regulatory use and routine production.

0.93% for other purposes.

No animals were used for forensic enquiries.

Table 2

Purpose of studies

2014

%

2016

%

DIFFERENCE 2014 / 2016

%

Basic research

41.84

35.42

-6.42

Translational research

31.77

26.54

-5.23

Regulatory testing

25.45

37.11

11.66

Other

0.94

0.93

-0.01

The downward trend in the number of animals used in basic research and translational research was confirmed in 2016.

The use of animals in regulatory testing (experiments that are compulsory under national, European and international law) was the most common purpose. (See Table 2)



3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Data collection on the level of suffering felt by animals was recorded for the third time in 2016. Comparing 2014, 2015 and 2016 shows that there were no material variations in the ‘non‑recovery’ and ‘mild’ suffering levels, while there has been an increase in the ‘severe’ category (see Table 3).

Table 3

Suffering level / Year

Non-recovery

Mild (up to and including)

Moderate

Severe

2014

4.89%

49.09%

42.90%

3.12%

2015

6.16%

47.58%

39.44%

6.82%

2016

4.81%

50.42%

34.11%

10.66%

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impact on statistics if any.

Legislative Decree No 26/2014, which transposes the European Directive, designated the laboratory of the cell substrates and cellular immunology department of the Lombardy and Emilia-Romagna Animal Disease Prevention Institute as the single contact point charged with providing advice on the suitability and regulatory appropriateness of alternative approaches proposed for validation studies.

That Decree earmarks funding for the development and validation of alternative methods and for staff training. This funding is € 1 million annually for the 2014-2016 period, broken down as follows:

§50% to be paid to the regions and autonomous provinces to finance training and refresher courses for staff of authorised establishments;

§50% to be paid to Animal Disease Prevention Institutes for research and development of alternative methods.

Monies from levying the new State administrative fines (see Article 40(25)) are also allocated to the development and validation of alternative methods.

Animal Welfare Bodies (OPBAs)

In 2016, greater awareness among and increased capacity for intervention by the Animal Welfare Bodies (OPBAs) in assessing research projects so as to issue reasoned opinions made it possible to verify, to the best extent possible, the correct application of the Three Rs principle, particularly in the basic research and translational research sectors. The OPBAs’ work enabled an assessment of the possibility of replacing one or more procedures with alternative methods and, where possible, also reducing the number of animals to be used, thus giving rise to a general downward trend in animal use except in the regulatory sector.

As far as staff skills are concerned, conferences, workshops and courses were organised by the National Reference Centre for Animal Welfare in Brescia, universities and other research institutes, with experts from the Ministry of Health participating as lecturers. The Ministry provided training at a total of 15 training courses in 2016.

Lastly, it is worth stressing the importance of the first National Animal Welfare Conference, which was devised and organised by the Directorate-General for Animal Health and Veterinary Medicines (DGSAF) at the Ministry of Health. The Conference had the positive effect of putting the spotlight on the issue of animal welfare in all sectors. More specifically, one session was devoted entirely to the topic of protecting the animals used for scientific purposes. The speakers stressed the innovations and developments brought about by Legislative Decree No 26/2014, which transposed the European Directive, but also highlighted the problem areas in which it is necessary to keep working so as to ensure that projects are assessed ever more carefully while keeping to the deadlines set in the Directive.

5. Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

Nothing to report.

6. Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

There were no cases in which the ‘severe’ classification was exceeded.

Italy: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

388976

63.59%

Rats

128186

20.96%

Guinea-Pigs

16977

2.78%

Hamsters (Syrian)

553

0.09%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

143

0.02%

Rabbits

15245

2.49%

Cats

Dogs

486

0.08%

Ferrets

7

0%

Other carnivores

Horses, donkeys and cross-breeds

19

0%

Pigs

1534

0.25%

Goats

53

0.01%

Sheep

232

0.04%

Cattle

115

0.02%

Prosimians

Marmoset and tamarins

9

0%

Cynomolgus monkey

488

0.08%

Rhesus monkey

6

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

8

0%

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

36701

6%

Other birds

468

0.08%

Reptiles

57

0.01%

Rana

Xenopus

771

0.13%

Other Amphibians

8

0%

Zebra fish

14664

2.4%

Other Fish

6001

0.98%

Cephalopods

Total

611707

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

557983

91.97%

Animals born in the EU but not at a registered breeder

46168

7.61%

Animals born in rest of Europe

835

0.14%

Animals born in rest of world

1690

0.28%

Total

606676

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

139

33.02%

Animals born in America

Animals born in Africa

282

66.98%

Animals born elsewhere

Total

421

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

94

22.33%

F2 or greater

327

77.67%

Self-sustaining colony

Total

421

100.00%



Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

216654

35.42%

Translational and applied research

162406

26.55%

Regulatory use and Routine production

226969

37.1%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

1551

0.25%

Preservation of species

167

0.03%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1787

0.29%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

2173

0.36%

Total

611707

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

59961

27.68%

Cardiovascular Blood and Lymphatic System

9330

4.31%

Nervous System

82143

37.91%

Respiratory System

2755

1.27%

Gastrointestinal System including Liver

4929

2.28%

Musculoskeletal System

8391

3.87%

Immune System

20124

9.29%

Urogenital/Reproductive System

4933

2.28%

Sensory Organs (skin, eyes and ears)

1689

0.78%

Endocrine System/Metabolism

5655

2.61%

Multisystemic

7227

3.34%

Ethology / Animal Behaviour /Animal Biology

6098

2.81%

Other basic research

3419

1.58%

Total

216654

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

45578

28.06%

Human Infectious Disorders

29058

17.89%

Human Cardiovascular Disorders

2074

1.28%

Human Nervous and Mental Disorders

19042

11.72%

Human Respiratory Disorders

17539

10.8%

Human Gastrointestinal Disorders including Liver

4221

2.6%

Human Musculoskeletal Disorders

6107

3.76%

Human Immune Disorders

5657

3.48%

Human Urogenital/Reproductive Disorders

1334

0.82%

Human Sensory Organ Disorders (skin, eyes and ears)

3540

2.18%

Human Endocrine/Metabolism Disorders

3441

2.12%

Other Human Disorders

6573

4.05%

Animal Diseases and Disorders

4309

2.65%

Animal Welfare

81

0.05%

Diagnosis of diseases

13214

8.14%

Plant diseases

Non-regulatory toxicology and ecotoxicology

638

0.39%

Total

162406

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

111607

49.17%

Other efficacy and tolerance testing

48352

21.3%

Toxicity and other safety testing including pharmacology

65075

28.67%

Routine production

1935

0.85%

Total

226969

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

24249

21.73%

Pyrogenicity testing

4352

3.9%

Batch potency testing

79363

71.11%

Other quality controls

3643

3.26%

Total

111607

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

11131

17.1%

Skin irritation/corrosion

738

1.13%

Skin sensitisation

11885

18.26%

Eye irritation/corrosion

134

0.21%

Repeated dose toxicity

8838

13.58%

Carcinogenicity

229

0.35%

Genotoxicity

307

0.47%

Reproductive toxicity

955

1.47%

Developmental toxicity

8593

13.2%

Neurotoxicity

25

0.04%

Kinetics

6155

9.46%

Pharmaco-dynamics (incl safety pharmacology)

495

0.76%

Phototoxicity

66

0.1%

Ecotoxicity

3833

5.89%

Safety testing in food and feed area

11049

16.98%

Target animal safety

24

0.04%

Other toxicity/safety testing

618

0.95%

Total

65075

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

1003

9.01%

Other lethal methods

439

3.94%

Non lethal methods

9689

87.05%

Total

11131

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

2794

31.61%

29 - 90 days

4214

47.68%

> 90 days

1830

20.71%

Total

8838

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3317

86.54%

Chronic toxicity

158

4.12%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

358

9.34%

Total

3833

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

1089

56.28%

Monoclonal antibody by mouse ascites method

Other product types

846

43.72%

Total

1935

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

147217

64.86%

Legislation on medicinal products for veterinary use and their residues

35207

15.51%

Medical devices legislation

18639

8.21%

Industrial chemicals legislation

9129

4.02%

Plant protection product legislation

401

0.18%

Biocides legislation

1119

0.49%

Food legislation including food contact material

11974

5.28%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

3283

1.45%

Total

226969

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

215219

94.82%

Legislation satisfying national requirements only [within EU]

1884

0.83%

Legislation satisfying Non-EU requirements only

9866

4.35%

Total

226969

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

607097

99.25%

Yes

4610

0.75%

Total

611707

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

29421

4.81%

Mild [up to and including]

308396

50.42%

Moderate

208660

34.11%

Severe

65230

10.66%

Total

611707

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

604369

98.8%

Yes

7338

1.2%

Total

611707

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

488643

79.88%

Genetically altered without a harmful phenotype

108952

17.81%

Genetically altered with a harmful phenotype

14112

2.31%

Total

611707

100.00%



Italy: Narrative 2017

Introduction

The data for Italy for 2017 are from the Ministry of Health – Directorate-General for Animal Health and Veterinary Medicines – Office 6 – Animal Welfare. They were collected via the National Electronic Database and, after suitability testing, were sent to the European Commission through the DECLARE platform.

1. General information on any changes in trends observed since the previous reporting period.

In 2017, the total number of animals used in testing for the first time (‘naïve’ animals) was 575,352, i.e. fewer than 600,000. This was lower than in 2015 (-1.20%) and 2016 (-5.54%) (see Figure 1). In any case, the data confirm the downward trend in the total number of animals used in testing, which has remained below the one million mark since 1999.

Figure 1

Translation of legends:

-Total number of naïve animals used in Italy 2015-2017

-Total number of animals used in Italy 2015-2017



2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2015-2017 (see Table 1), rodents and animals accounted for 89.55% of the animal species used, including reused animals. Within these species, there was a decrease in the number of rodents and a significant increase in the number of rabbits. The increase in the number of rabbits is explained by the fact that around 95% of them are used in regulatory testing, i.e. tests that are compulsory under European or international law.

With regard to regulatory tests on rabbits, 78% of rabbits were used for quality controls on batches of medicines for human use, medical devices and veterinary medicines.

Another increase was in the use of non-human primates in regulatory tests (toxicity and other safety tests) required by European and international law (from 86.75% in 2015 to 97.27% in 2017). In consequence, there was a percentage decrease in non-human primates used in basic research in the three-year period concerned (from 11.67% in 2015 to 0.68% in 2017).

The most frequently used species was Macaca fascicularis; 2017 saw an increase in the use of generation F1 animals owing to reduced availability of generation F2 animals from breeding establishments and suppliers of non-human primates and the simultaneous increase in the number of regulatory tests.

For other animal species, there was a continuous increase in the 2015-2017 period in the use of:

·zebrafish in basic and translational research in the area of oncology and gastrointestinal diseases and in regulatory testing (ecotoxicity);

·other fish in translational research in the area of animal diseases.

Table 1

Animal species

% of the 2015 total

% of the 2016 total

% of the 2017 total

AVERAGE % - 2015-2017

% DIFFERENCE 2015 / 2017

Rodents

89.02%

87.43%

84.73%

87.06%

-4.82 %

Rabbits

1.66%

2.49%

3.33%

2.49%

+97.70%

Total rodents + rabbits

90.68%

89.82%

88.06%

89.52%

-2.89%

Other animal species

9.32%

10.18%

11.94%

10.48%

+28.11%

Total (all species)

100.00%

100.00%

100.00%

100.00%

For 2017:

33.55% of the animals were used in basic biological studies.

26.48% were used in translational or applied research.

38.96% were used for regulatory use and routine production.

1.01% of the animals were used for other purposes.

No animals were used for forensic enquiries.

Table 2

Animal uses by purpose of studies

Purpose of studies

% 2015

% 2016

% 2017

Basic research

37.26%

35.42%

33.55%

Translational research

24.92%

26.54%

26.48%

Regulatory testing

36.07%

37.11%

38.96%

Other

1.75%

0.93%

1.01%

The downward trend in the number of animals used for basic research was confirmed in 2017.

The use of animals for regulatory testing (experiments that are compulsory under national, European and international law) was the most common purpose and is continually increasing (see Table 2).

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Data collection on the level of suffering felt by animals (see Table 3) was recorded for the fourth time in 2017.

Table 3

Suffering level / Year

Non-recovery

Mild (up to and including)

Moderate

Severe

2015

6.16%

47.58%

39.44%

6.82%

2016

4.81%

50.42%

36.11%

10.66%

2017

5.49%

48.45%

30.55%

15.50%

Comparing the data for the 2015-2017 period shows that:

·there were no material variations in the ‘non-recovery’ and ‘mild’ suffering levels, which together represent 54%;

·there was a continuous decrease in the ‘moderate’ suffering level;

·there was an increase in the ‘severe’ category.

The animal species most concerned by the increase in the ‘severe’ suffering level is mice, at around 80%.

The correlation between the ‘severe’ suffering level and purpose is as follows:

·46.62% for basic research (in particular for studies of central nervous system diseases and cancer);

·37.14% for translational research (in particular for cancer);

·15.89% for regulatory tests (in particular for toxicity);

·0.35% for other purposes (maintenance of colonies of genetically altered animals).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impact on statistics if any.

Legislative Decree No 26/2014, which transposes the European Directive, designated the laboratory of the cell substrates and cellular immunology department of the Lombardy and Emilia-Romagna Animal Disease Prevention Institute as the single contact point charged with providing advice on the suitability and regulatory appropriateness of alternative approaches proposed for validation studies.

That Decree earmarked funding for the development and validation of alternative methods and for staff training. The funding was € 1 million annually for the 2014-2016 period, broken down as follows:

§50% to be paid to the regions and autonomous provinces to finance training and refresher courses for staff of authorised establishments;

§50% to be paid to Animal Disease Prevention Institutes for research and development of alternative methods.

Monies from levying the new State administrative fines (see Article 40(25)) are also allocated to the development and validation of alternative methods.

National Committee for the Protection of Animals Used for Scientific Purposes

The National Committee for the Protection of Animals Used for Scientific Purposes was set up in February 2017. It is made up of members representing academia, public scientific research institutions, the Ministry of Health, the Italian National Institute of Health and the National Reference Centre for Alternative Methods and Welfare and Care of Laboratory Animals.

After drawing up its rules of procedure, its activities included providing the Ministry of Health with advice on preparing the draft ministerial decree on staff training.

Since October 2017 the National Committee has been working on organising the work of the Animal Welfare Bodies (OBPAs) with the aim of harmonising that work, particularly as regards preliminary assessment of research projects with a view to issuing the reasoned opinion needed for authorisation applications for such projects.

To that end, the National Committee has launched a major initiative to raise awareness among OPBAs so as to harmonise their activities in both logistical and technical terms, and in particular to encourage the sharing of project assessment criteria.

Animal Welfare Bodies (OPBAs)

In general terms, 2017 saw the consolidation of greater awareness among and increased capacity for intervention by the Animal Welfare Bodies (OPBAs) in assessing research projects so as to issue reasoned opinions. This made it possible to verify, to the best possible extent, the correct application of the Three Rs principle, particularly as regards the replacement or reduction of animal use, with clear results in the basic research and translational research sectors.

As far as staff skills are concerned, conferences, workshops and courses were organised by various public or private bodies, with experts from the Ministry of Health participating as lecturers/speakers in 14 events.

5. Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

The ‘other’ heading is used for the main sub-sectors, which mainly concern the regulatory field.

More specifically:

Animals used in routine production:

Other efficacy and tolerance testing (immunogenicity for human vaccines)

Other efficacy and tolerance testing (production of inactivated antigens for animal vaccines)

Animals used in the quality control sector:

Other quality controls (efficacy testing on rodenticides; testing for contaminants in veterinary medicines)

Animals used in the toxicity testing sector:

Other toxicity/safety testing (for drugs of abuse; for anomalous toxicity; for local tolerance)

Animals used in the acute and sub-acute toxicity methods sector:

Other lethal methods (testing in accordance with OECD 402 and OECD 423)

Animals used in the toxicity/ecotoxicity testing sector:

Other tests: (Diagnostic ecotoxicity testing)

6. Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

There were no cases in which the ‘severe’ classification was exceeded.

Italy: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

358128

61.74%

Rats

118104

20.36%

Guinea-Pigs

14357

2.48%

Hamsters (Syrian)

277

0.05%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

647

0.11%

Rabbits

19325

3.33%

Cats

Dogs

639

0.11%

Ferrets

42

0.01%

Other carnivores

Horses, donkeys and cross-breeds

17

0%

Pigs

1657

0.29%

Goats

23

0%

Sheep

192

0.03%

Cattle

279

0.05%

Prosimians

Marmoset and tamarins

1

0%

Cynomolgus monkey

569

0.1%

Rhesus monkey

4

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

30

0.01%

Domestic fowl

34715

5.98%

Other birds

420

0.07%

Reptiles

Rana

Xenopus

401

0.07%

Other Amphibians

Zebra fish

19508

3.36%

Other Fish

10715

1.85%

Cephalopods

10

0%

Total

580060

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

507078

88.22%

Animals born in the EU but not at a registered breeder

65027

11.31%

Animals born in rest of Europe

874

0.15%

Animals born in rest of world

1825

0.32%

Total

574804

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

1

0.18%

Animals born in rest of Europe

Animals born in Asia

57

10.4%

Animals born in America

Animals born in Africa

490

89.42%

Animals born elsewhere

Total

548

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

137

25%

F2 or greater

411

75%

Self-sustaining colony

Total

548

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

194642

33.56%

Translational and applied research

153743

26.5%

Regulatory use and Routine production

225842

38.93%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

1697

0.29%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1598

0.28%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

2538

0.44%

Total

580060

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

58513

30.06%

Cardiovascular Blood and Lymphatic System

8635

4.44%

Nervous System

74343

38.19%

Respiratory System

1384

0.71%

Gastrointestinal System including Liver

5792

2.98%

Musculoskeletal System

6933

3.56%

Immune System

13667

7.02%

Urogenital/Reproductive System

2830

1.45%

Sensory Organs (skin, eyes and ears)

3892

2%

Endocrine System/Metabolism

4776

2.45%

Multisystemic

3858

1.98%

Ethology / Animal Behaviour /Animal Biology

5028

2.58%

Other basic research

4991

2.56%

Total

194642

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

46470

30.23%

Human Infectious Disorders

21902

14.25%

Human Cardiovascular Disorders

1852

1.2%

Human Nervous and Mental Disorders

18498

12.03%

Human Respiratory Disorders

16658

10.83%

Human Gastrointestinal Disorders including Liver

2706

1.76%

Human Musculoskeletal Disorders

6007

3.91%

Human Immune Disorders

3875

2.52%

Human Urogenital/Reproductive Disorders

2992

1.95%

Human Sensory Organ Disorders (skin, eyes and ears)

2457

1.6%

Human Endocrine/Metabolism Disorders

3064

1.99%

Other Human Disorders

5288

3.44%

Animal Diseases and Disorders

7228

4.7%

Animal Welfare

918

0.6%

Diagnosis of diseases

13483

8.77%

Plant diseases

Non-regulatory toxicology and ecotoxicology

345

0.22%

Total

153743

100.00%



Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

111851

49.53%

Other efficacy and tolerance testing

45856

20.3%

Toxicity and other safety testing including pharmacology

63786

28.24%

Routine production

4349

1.93%

Total

225842

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

21535

19.25%

Pyrogenicity testing

2717

2.43%

Batch potency testing

84520

75.56%

Other quality controls

3079

2.75%

Total

111851

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

10612

16.64%

Skin irritation/corrosion

820

1.29%

Skin sensitisation

11983

18.79%

Eye irritation/corrosion

93

0.15%

Repeated dose toxicity

8757

13.73%

Carcinogenicity

Phototoxicity

Genotoxicity

291

0.46%

Reproductive toxicity

628

0.98%

Developmental toxicity

5554

8.71%

Neurotoxicity

300

0.47%

Kinetics

5976

9.37%

Pharmaco-dynamics (incl safety pharmacology)

1154

1.81%

Ecotoxicity

4224

6.62%

Safety testing in food and feed area

10807

16.94%

Target animal safety

1212

1.9%

Other toxicity/safety testing

1375

2.16%

Total

63786

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

1211

11.41%

Other lethal methods

755

7.11%

Non lethal methods

8646

81.47%

Total

10612

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

4157

47.47%

29 - 90 days

2782

31.77%

> 90 days

1818

20.76%

Total

8757

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3930

93.04%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

294

6.96%

Total

4224

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

2861

65.79%

Monoclonal antibody by mouse ascites method

Other product types

1488

34.21%

Total

4349

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

143853

63.7%

Legislation on medicinal products for veterinary use and their residues

37188

16.47%

Medical devices legislation

19575

8.67%

Industrial chemicals legislation

8715

3.86%

Plant protection product legislation

595

0.26%

Biocides legislation

624

0.28%

Food legislation including food contact material

11492

5.09%

Feed legislation including legislation for the safety of target animals, workers and environment

1074

0.48%

Cosmetics legislation

Other legislation

2726

1.21%

Total

225842

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

209119

92.6%

Legislation satisfying national requirements only [within EU]

3418

1.51%

Legislation satisfying Non-EU requirements only

13305

5.89%

Total

225842

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

575352

99.19%

Yes

4708

0.81%

Total

580060

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

31875

5.5%

Mild [up to and including]

281069

48.46%

Moderate

177180

30.55%

Severe

89936

15.5%

Total

580060

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

571715

98.56%

Yes

8345

1.44%

Total

580060

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

448697

77.35%

Genetically altered without a harmful phenotype

112874

19.46%

Genetically altered with a harmful phenotype

18489

3.19%

Total

580060

100.00%



Latvia

Latvia: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

In 2014 competent authority has approved 8 projects, but in 2015 – 9, however since the previous year, animal amount used for scientific purposes have decreased from 13730 in 2014 to 5457 in 2015. During the 2014 active research was performed in 12 projects, but in 2015 – in 16 projects and one project was not realized because the lack of funding. Compeering previous period, in 2015 were realised more small projects with quite a small total animal amount not exceeding number of 100 animals per one project.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2015 new types of species were used in procedures – dogs (7), domestic fowl (40) and rabbits (35). Comparing 2014 and 2015 data using of pigs have decreased and wild birds have not been use because a lack of funding.

Animal species used in procedures in 2014 and 2015 are exposed on Figure 1. and Figure 2

Figure 1

Figure 2

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

All animals used in procedures come from EU origin, and biggest part 98.0% from the registered breeder.

Figure 3

In total 349 animals (6.40%) were used in planned severe procedures, including 81 mice and 182 rats for human nervous and mental disorders research. Procedures were appreciated as sever because of surgical intervention in brain cavity, but animals were not exposed to additional severe or moderate pain in long term. 74 mice and 12 rats from not planned severe procedures actually went through severe procedure because of individual reaction during surgery under anaesthesia (sudden death) and unexpected deterioration of health state (weight loss, hyperglycaemia), however mostly detecting heavier sufferings than were expected, animals were excluded from further steps of procedure and were humanely euthanized.

The biggest part 1977 (36.23%) of animals were exposed to planned moderate procedures, including 739 mice and 94 rats for human nervous and mental disorders research, 48 mice, 69 rats and 20 rabbits for human musculoskeletal disorders, 11 mice for nervous system (basic research), 37 mice for cancer, 78 mice for human immune disorders, 451 mice, 7 dogs and 15 rabbits for animal diseases and 367 mice for non-regulatory toxicology research (see Figure 3). 41 mice from not planned moderate procedures were exposed to moderate procedure because of individual reaction to adjuvant (not completed absorption and forming subcutaneous induration).

In mild procedures were used 1842 (33.75%) animals including 1565 mice for human nervous and mental disorders research, 62 mice for human immunes system disorders and 40 domestic fowl for animal diseases research; 64 rats exposed to mild surgical intervention (sham operated animals) and 4 mice from procedures with harder character because of not desired effect and pathological state forming were excluded from further research process and underwent only mild manipulations

In non-recovery procedures were used 1289 (23.62%) animals including 520 mice and 746 rats for non-regulatory toxicology and ecotoxicology and 23 pigs for educational purposes

In general observation there are evident changes in the basic research, where animal using were decreased significantly from 1280 (9.32%) in 2014 to 11 (0.20%), also the number of animals used for educational purposes comparing previous year decreased from 150 (1.09%) to 23 (0.42%) in 2015 as well as in 2015 animals were not used in protection of natural environment in the interests of the health animal beings. The highest amount of animal using remain unchanged in translation and applied research. This year reaching 99.38% (5423) of all used animals and increasing for 14.97% comparing with previous year. This is explained with trend between researchers mainly to devote their activities to investigation of new substances with therapeutic effect.

Reason for animal amount changes mentioned previous is a result of scientist more carefully planned work and choosing new less harmful research methods. During the continuously scientific work researchers are looking for new alternative methods and ways to minimize animal using in procedures and as it is seen from data in some projects animals are not used at all in this year instead of planned.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Scientific project authors strive to use in silico and in vitro methods in substance testing processes to detect most effective sample before animal using as well as explore literature and collaborate with other scientist doing research and use other surveys to avoid repeated studies and to use as little as possible animals in procedures. During the project evaluation process competent authority and experts ensures and verifies the project scientific utility and benefits, analyse possibility to replace animals with alternative methods as well as evaluate presented animal amount in procedures and research methods and techniques. Competent authority and experts verifies weather it is possible to achieve the objectives pursued in project according to the project plan.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In 2015, as the project was continued from 2014, 23 pigs were used in non-recovery procedures for higher education purposes (human and veterinary surgeons training). After procedure (surgical intervention) pigs were euthanized. As much as possible were done surgical procedures with each animal under anaesthesia and narcosis to decrease used animal amount in procedures.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

During the year 2015 users have reported to competent authority that 8 rats exposed to narcosis unexpectedly died during the surgical manipulation. In 2015 users have not asked competent authority to approve procedures where the 'severe' classification is exceeded.

Latvia: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

4165

76.32%

Rats

1187

21.75%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

35

0.64%

Cats

Dogs

7

0.13%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

23

0.42%

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

40

0.73%

Other birds

0

0%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

5457

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

5359

98.2%

Animals born in the EU but not at a registered breeder

98

1.8%

Animals born in rest of Europe

Animals born in rest of world

Total

5457

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

11

0.2%

Translational and applied research

5423

99.38%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

0

0%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

23

0.42%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

5457

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

11

100%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

11

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

52

0.96%

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

2763

50.95%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

141

2.6%

Human Immune Disorders

270

4.98%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

564

10.4%

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

1633

30.11%

Total

5423

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

5457

100%

Yes

Total

5457

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

1289

23.62%

Mild [up to and including]

1842

33.75%

Moderate

1977

36.23%

Severe

349

6.4%

Total

5457

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

5457

100%

Yes

Total

5457

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

5457

100%

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

5457

100.00%



Latvia: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

In 2015 competent authority has approved 9 projects, but in 2016 – 3. Since the previous year, animal amount used for scientific purposes have not significantly changed (5457 in 2015 and 5458 in 2016). During the 2015 active research was performed in 16 projects, but in 2016 – in 17 projects. In 2016 the first time researchers started to use genetically altered animals – 60 mice in moderate procedures for basic research (human nervous system).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Compeering last two years the total amount of used mice have increased from 76.32% in 2015 (n=4165) to 84.3% (n=4601) in 2016, but total amount of used rats have decreased from 21.75% (n=1.187) in 2015 to 11.58% (n=632) in 2016. The reason for these changes is connected with economical (new synthesised substances are very expensive and therefore usually are synthesised in small amounts that leads to great need for smaller animals used in further in vivo tests) animal welfare and 3Rs considerations (suggestions from project evaluation commission). In 2016 dogs and domestic fowl were not used because the end of the projects in previous year, but after financial improvement the part of wild nature research project was realized and 171 wild birds were exposed to mild procedure.

Animal species used in procedures in 2014, 2015 and 2016 are exposed on Figure 1.

                   Figure 1

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

All animals used in procedures come from EU origin, and biggest part 95.9% from the registered breeder.

The biggest part of all animals were used in mild procedures (see Fig. 2) – 48.3% (n=2637) from which 2516 were used for planned mild procedures, but 121, which came from a control groups and sham operated groups of cardiovascular disease, human nervous and mental disorders research projects and in general were planned to expose to moderate procedures, but actually underwent easier or not all manipulations comparing to other experimental groups in the same procedure. Therefore previous mentioned animal (n=121) sufferings were evaluated as mild.

Figure 2

In total in 2016 animals were not used in planned severe procedures, but 100 animals (1.8%) in four projects actually went through severe procedure.

1.During mild procedure in human cardiovascular disease research project 4 mice lost weight more than 25 % and therefore animals were humanely killed and were not included in further manipulations.

2.During moderate procedure in human cancer research project 35 mice lost weight more than 25 % and therefore animals were humanely killed and were not included in further manipulations.

3.Because of specific individual features during moderate procedure in human infectious disorders research project 4 mice recovered very hard after long exposing to narcosis during electroporation and therefore animals were humanely killed and were not included in further manipulations.

4.During moderate procedure in human musculoskeletal disorders research project 1 rabbit died. The case was not convinced with procedure, but during the time of procedure previous unknown acquired digestion disorders exacerbated resulting with death.

5.During moderate procedure in animal diseases and disorders research, 56 mice died without previously detectable signs of suffering.

In moderate procedures in 2016 was used 1853 (33.95%) animals from which 1851 animals were exposed to planned moderate procedures, but 2 animals actually went through moderate procedures in human infections diseases research project because after using adjuvant (incomplete Freund's adjuvant) bad absorption in tissue was observed. Tissue thickening was remarked. It disappeared in 3-5days after injection was made. In moderate procedures 563 mice and 24 rats were used for trans/Appl human nervous and mental disorders, 48 mice, 418 mice for animal diseases and disorders research, 60 mice for basic nervous system research, 46 for human infectious and disorders research, 13 rabbits for musculoskeletal diseases and disorders and 158 mice for non-regulatory toxicology and ecotoxicology research (see Figure 3).

In 2016 868 (15.9%) animals were used in non-recovery procedures, including 260 mice and 560 rats in human cardiovascular disorders research projects and 40 pigs for higher education purposes (human and veterinary surgeons training).

In general observation there are evident changes in the basic research, where increased animal using in mild procedures (almost 2/3 form used animals for basic research), but still saving quite small amount – 3.2% (n=160) comparing with other research purposes.

The main research purpose is translation and applied research. This is explained with trend between researchers mainly to devote their activities to investigation of new substances with therapeutic effect. In this research branch for the last three years decreased animal using, especially in harder procedures (see Fig.3), but increased animal using in mild procedures. In 2014 animals were not used in mild procedures. In 2014 and 2015 biggest amount of animals were used in severe and moderate procedures, but in 2016 – in mild procedures (46.4%) and in the same time animal using in severe procedures were low (1.9%).

                                           



Figure 3

Reason for animal amount changes mentioned previous (tendency to decrease animal using in harmful procedures) is a result of scientist more carefully planned work and choosing new less harmful research methods. During the continuously scientific work researchers are looking for new alternative methods and ways to minimize animal using in procedures as well as project evaluation commission suggestions concerning 3RS principles are taken in notice. Moreover, project authors strive to use more in vitro, in silico and ex vivo methods (for example – isolated organs, cells or organelles instead of live animal using), especially for toxicity and effectivity first stage tests.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Scientific project authors strive to use in silico, in vitro and ex vivo methods in substance testing processes to detect most effective sample before animal using as well as explore literature and collaborate with other scientists doing research and use other surveys to avoid repeated studies and to use as little as possible animals in procedures. During the project evaluation process competent authority and experts ensures and verifies the project scientific utility and benefits, analyse possibility to replace animals with alternative methods as well as evaluate presented animal amount in procedures and research methods and techniques. Competent authority and experts verifies weather it is possible to achieve the objectives pursued in project according to the project plan.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In 2015, as the project was continued from 2014, 23 pigs were used in non-recovery procedures for higher education purposes (human and veterinary surgeons training), but in 2016 – 40 pigs. After procedure (surgical intervention) pigs were euthanized. As much as possible were done surgical procedures with each animal under anaesthesia and narcosis to decrease. Increase of pig using in non-recovery procedure probably is associated with more frequent training requests from surgeons.

Compeering previous year, in 2016 171 wild birds were used in wild nature research project. This project was authorized in previous year, but financial difficulties did not allow to realize project in 2015, but in 2016 after improvement of financial position, this project was resumed.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

During the year 2016 users have not reported to competent authority that animals exposed to narcosis exceed classified “severe” procedure. In 2016 users have not asked competent authority to approve procedures where the 'severe' classification is exceeded.

Latvia: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

4601

84.3%

Rats

632

11.58%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

14

0.26%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

40

0.73%

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

171

3.13%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

5458

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

5233

95.88%

Animals born in the EU but not at a registered breeder

225

4.12%

Animals born in rest of Europe

Animals born in rest of world

Total

5458

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

160

2.93%

Translational and applied research

5087

93.2%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

171

3.13%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

40

0.73%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

5458

100.00%



Basic Research

Basic Research

Number of uses

Percentage

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

160

100%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

160

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

604

11.87%

Human Infectious Disorders

108

2.12%

Human Cardiovascular Disorders

2277

44.76%

Human Nervous and Mental Disorders

1448

28.46%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

14

0.28%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

478

9.4%

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

158

3.11%

Total

5087

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

5458

100%

Yes

Total

5458

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

868

15.9%

Mild [up to and including]

2637

48.31%

Moderate

1853

33.95%

Severe

100

1.83%

Total

5458

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

5458

100%

Yes

Total

5458

100.00%



Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

5398

98.9%

Genetically altered without a harmful phenotype

60

1.1%

Genetically altered with a harmful phenotype

Total

5458

100.00%



Latvia: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In 2015 competent authority has approved 9 projects, in 2016 – 3, but in 2017 - 13. Since the previous years, animal amount used for scientific purposes have not significantly changed (5457 in 2015 and 5458 in 2016), but slightly decreased – 5289 in 2017. During the 2015 active licence was for 16 projects, in 2016 – for 17, but in 2017 – for 25 projects. However it does not mean that in all projects all procedures were performed and projects realised as planned. In some cases projects or procedures were stopped for a while because the lack of financing or additional research before preclinical trials. Year by year the science quickly develops and that is why researchers after getting new information concerning their research topic uses in vitro methodology as much as possible, and it results with decreasing total amount of animals. In most of cases, especially in long lasting projects (5-year projects), researchers use less animals as they have written down in project licence application.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Comparing last three years the total amount of used mice have increased from 76.32% in 2015 (n=4165) to 84.3% (n=4601) in 2016 but in 2017 – decreased 63.0% (3332) (see Fig.1). Total amount of used rats have decreased from 21.75% (n=1187) in 2015 to 11.58% (n=632) in 2016, but increased in 2017 to 33.94% (1795). The reason for these changes is that in 2017 researchers have realized more projects where rats were included. In some specific investigations or testing of new substances rats were preferred because of their size. Rat’s bigger size comparing to mice allow researchers to get more biological samples (for example – tissue, blood samples or tumour cells) for in vitro testing and in the same time also t allow to use less animals and get more necessary data. Compeering previous years in 2017 wild birds were not used for scientific purposes because of project ending however other wild species – bats (Pipistrellus nathusii) were used for mild procedures (basic research for white nose syndrome by taking blood samples for molecular analysis and investigation of their behaviour).

               



Figure 1

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

All animals used in procedures come from EU origin, and the biggest part 96.4% from the registered breeder.

The biggest part of all animals were used in mild procedures (see Fig. 2 and Fig. 3) – 38.76% (n=2050) from which 1919 were used for planned mild procedures, but

a)2 mice because the lack of tumour development were killed before the end of planned moderate procedure ((Trans/Appl Research) Human Cancer) and actually were exposed to mild procedure;

b)24 rats and 65 mice were used as control group in moderate procedure ((Trans/Appl Research) Human Nervous and Mental Disorders) and were shame operated that finally did not cause further disabilities or dysfunctions except skin cut and finally resulted as mild procedure;

c)40 rats were used in moderate procedure ((Basic Research) Nervous System) as animals of control group and did not underwent all manipulations comparing to other experimental groups, therefore actually were exposed to mild procedure.

Figure 2

In total 166 (3.14%) animals in 2017 were used in severe procedures from which 114 animal were used for planned severe procedures (4 mice for (Basic Research) Oncology, and 110 mice for (Trans/Appl Research) Non-regulatory toxicology and ecotoxicology) but 52 mice and 2 rats from three projects went through severe not planned procedure.

1.During moderate procedure ((Trans/Appl Research) Human Nervous and Mental Disorders) 18 mice died during the surgical manipulations and did not wake up after anaesthesia.

2.During moderate procedure ((Trans/Appl Research) Human Cancer) 34 animals lost weight more then 25% and therefore animals were humanely killed and were not included in further manipulations.

Figure 3

In moderate procedures in 2017 was used 1701 (32.16%) animals from which 804 mice were used in (Trans/Appl Research) Human Cancer research, 249 mice and 94 rats for (Trans/Appl Research) Human Nervous and Mental Disorders research, 59 rats for (Basic Research) Nervous System research and 374 mice for (Trans/Appl Research) Animal Diseases and Disorders research.

In 2017 1372 (25.94%) animals were used in non-recovery procedures, including 1300 rats for (Trans/Appl Research) Human Cardiovascular Disorders, 50 mice for (Basic Research) Nervous System and 22 pigs for Higher education or training for the acquisition, maintenance or improvement of vocational skills (human and veterinary surgeons training).

In general observation there are evident changes in severity of procedures. Comparing previous years in 2017 increased animal using in severe and non-recovery procedures. That is explained by long lasting projects (5-year projects) that were stopped for one or two year period for various reasons (lack of financing, additional in vitro research) but realized in 2017.

The main research purpose is translation and applied research. This is explained with trend between researchers mainly to devote their activities to investigation of new substances with therapeutic effect.

In this research branch for the last two years decreased animal using, especially in harder procedures (see Fig. 4), but in 2017 increased animal using in non-recovery, severe and moderate procedures.

Figure 4

Reason for animal amount changes mentioned previous (tendency to decrease animal using in harmful procedures in 2015 and 2016) is a result of scientist more carefully planned work and choosing new less harmful research methods. During the continuous scientific work researchers are looking for new alternative methods and ways to minimize animal using in procedures as well as project evaluation commission suggestions concerning 3RS principles are taken in notice. Moreover, project authors strive to use more in vitro, in silico and ex vivo methods (for example – isolated organs, cells or organelles instead of live animal using), especially for toxicity and effectivity first stage tests. However increasing of animal using in non-recovery, moderate and severe procedures in 2017 is explained with interruption of long lasting projects (5-year lasting projects) and not fully realization during the time of first years authorization because of additional in vitro research and/or lack of finances.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Authors of scientific projects strive to use in silico, in vitro and ex vivo methods in substance testing processes to detect most effective sample before animal using as well as explore literature and collaborate with other scientists doing research and use other surveys to avoid repeated studies and to use as little as possible animals in procedures. During the project evaluation process competent authority and experts ensures and verifies the project scientific utility and benefits, analyse possibility to replace animals with alternative methods as well as evaluate presented animal amount in procedures and research methods and techniques. Competent authority and experts verifies weather it is possible to achieve the objectives pursued in project according to the project plan. If there are any possibility to decrease animal sufferings or to decrease a total amount of animals in procedures, applicants are strictly obligated to make changes in project before authorization. In addition – during inspections each project is checked according to approved methodology.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In 2015, as the project was continued from 2014, 23 pigs were used in non-recovery procedures for higher education purposes (human and veterinary surgeons training), 40 pigs – in 2016 and 22 pigs in 2017. After procedure (surgical intervention) pigs were euthanized. As much as possible manipulations (cuts, trainings of surgical techniques) were done with each animal under anaesthesia and narcosis to decrease a total amount of animals. Decrease of pig using in non-recovery procedure probably is associated with less frequent training requests from surgeons. In 2017 140 bats (Pipistrellus nathusii) were used for basic research (animal behaviour and infectious disease) in mild procedures. The procedure involved such a manipulations as blood and skin biopsy sample taking and observation of behaviour after animals were freed.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

During the year 2017 users have reported two cases were animals did not awake after surgical intervention and narcosis (26 mice) and one case where 34 mice in cancer research where euthanized before the end of procedure because of weight lost more than 25%.

In 2017 users have not asked competent authority to approve procedures where the 'severe' classification is exceeded.



Latvia: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

3332

63%

Rats

1795

33.94%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

22

0.42%

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

140

2.65%

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

5289

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

5127

96.94%

Animals born in the EU but not at a registered breeder

162

3.06%

Animals born in rest of Europe

Animals born in rest of world

Total

5289

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1724

32.6%

Translational and applied research

3543

66.99%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

22

0.42%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

5289

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

4

0.23%

Cardiovascular Blood and Lymphatic System

Nervous System

1580

91.65%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

140

8.12%

Other basic research

Total

1724

100.00%



Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

840

23.71%

Human Infectious Disorders

135

3.81%

Human Cardiovascular Disorders

1406

39.68%

Human Nervous and Mental Disorders

605

17.08%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

70

1.98%

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

0

0%

Other Human Disorders

Animal Diseases and Disorders

377

10.64%

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

110

3.1%

Total

3543

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

5289

100%

Yes

Total

5289

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

1372

25.94%

Mild [up to and including]

2050

38.76%

Moderate

1701

32.16%

Severe

166

3.14%

Total

5289

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

5289

100%

Yes

Total

5289

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

5229

98.87%

Genetically altered without a harmful phenotype

60

1.13%

Genetically altered with a harmful phenotype

Total

5289

100.00%



Lithuania

Lithuania: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

In 2015, there were 2451 laboratory animals employed for animal studies and other scientific purposes in Lithuania. In comparison to the previous year ~ 1000 less animals were used for the projects. Reduction can be justified due to the expiry date of more than 32 % projects in 2015.

The number of users increased from 8 in 2013 to 12 in 2015, however some establishments finished some projects in 2015.

Increase in use of birds is noticed.

Significant decrease in use of animals for the procedures classified as non-recovery.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The total number of animals used in specific areas is affected by many factors (i.e. active projects, funding, international projects ect.)

i. e. increase in use of animals for the purpose „Protection of the natural environment in the interests of the health or welfare of human beings or animals“ was directly related to one project where other birds (Serinus canaria) were used.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Most part of the animals (~64 %) were used for the procedures classified as mild [up to and including] severity, (~ 32 %) as moderate and (~4 %) as non-recovery.

Only Directive 2010/63/EU contains the requirement that all procedures should be classified, and no analogous to the system used in the Directives was introduced in the national legislation before, so this required additional input from users.

So significant decrease in use of animals for the procedures classified as non-recovery is mostly due to a better understanding of classification and better reporting of the actual severities by the users in 2015.

There was no exceeding of the ‘severe’ classification reported in 2015, because National Committee is encouraging users do not perform projects or organize project in such a way where animals could not be used for procedures classified as severe.



4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Activities undertaken under Article 47 of Directive 2010/63/EU on the protection of animals used for scientific purposes to contribute to the development, validation and promotion of alternative approaches and dissemination of information thereon at the national level for the period 2013–2015 are publically available on the webpage of the European Commission http://ec.europa.eu/environment/chemicals/lab_animals/3r/pdf/Article_47_LT.pdf

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

As regards the category “Other”, only other birds (Serinus canaria) were used for one project during the reporting period.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No authorisations for projects where the 'severe' classification is exceeded were granted during the reporting period. No exemptions under article 6(4)(a) of the Directive 2010/63/EU were granted in 2015, either

Lithuania: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1591

64.91%

Rats

572

23.34%

Guinea-Pigs

85

3.47%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

122

4.98%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

13

0.53%

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

64

2.61%

Reptiles

4

0.16%

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

2451

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2245

91.6%

Animals born in the EU but not at a registered breeder

206

8.4%

Animals born in rest of Europe

Animals born in rest of world

Total

2451

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

2041

83.27%

Translational and applied research

302

12.32%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

64

2.61%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

44

1.8%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

2451

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

388

19.01%

Cardiovascular Blood and Lymphatic System

275

13.47%

Nervous System

180

8.82%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

537

26.31%

Immune System

540

26.46%

Urogenital/Reproductive System

3

0.15%

Sensory Organs (skin, eyes and ears)

30

1.47%

Endocrine System/Metabolism

Multisystemic

60

2.94%

Ethology / Animal Behaviour /Animal Biology

Other basic research

28

1.37%

Total

2041

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

22

7.28%

Human Infectious Disorders

Human Cardiovascular Disorders

16

5.3%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

62

20.53%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

20

6.62%

Plant diseases

Non-regulatory toxicology and ecotoxicology

182

60.26%

Total

302

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

2451

100%

Yes

Total

2451

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

96

3.92%

Mild [up to and including]

1574

64.22%

Moderate

781

31.86%

Severe

Total

2451

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

2451

100%

Yes

Total

2451

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

2451

100%

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

2451

100.00%



Lithuania: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

In 2016, there were 2660 laboratory animals used for scientific or educational purposes in Lithuania. In comparison to the previous year, ~200 more animals were used in the projects.

It was caused by the fact, that more establishments were approved and (or) started performing projects. The number of users increased from 8 in 2013 to 14 in 2016.

The clearest trends in 2016 were increase in the use of farm animals for the purposes “Higher education or training for the acquisition, maintenance or improvement of vocational skills” and “Regulatory use and Routine production“.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Almost 4 % of all the animals were used directly for the purpose “Higher education or training for the acquisition, maintenance or improvement of vocational skills” and it was almost twice as many in comparison to the previous year. Increase of animals used for this activity was related to an increased number of hospital type training centers due to active participation in international projects related to surgery training exercises.

The reason for some other changes in use of animals in any of the specific areas is that some approved establishments did not perform any projects in 2016 and other started or continued new projects in the end of the previous year.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Increase in use of animals for the purpose “Higher education or training for the acquisition, maintenance or improvement of vocational skills” was partly related to the increased number of animals used for procedures classified as non-recovery.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Activities undertaken under Article 47 of Directive 2010/63/EU on the protection of animals used for scientific purposes to contribute to the development, validation and promotion of alternative approaches and dissemination of information thereon at the national level for the period 2013–2015 are publically available on the webpage of the European Commission http://ec.europa.eu/environment/chemicals/lab_animals/3r/pdf/Article_47_LT.pdf

Substantial attention was given to 3R principles in personnel training. Training programmes were amended in terms of 3R theoretical and practical activities related to the search of animal alternatives by the organisers and approved by the competent authority.

5. Further breakdown on the use of “other” categories if a significant proportion of animal use is reported under this category.

As regards the category “Other”, no other animals were used during the reporting period.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No authorisations for projects where the 'severe' classification is exceeded were granted during the reporting period.

No exemptions under article 6(4)(a) of Directive 2010/63/EU were granted in 2016 as well as in 2015.

Lithuania: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1759

66.13%

Rats

744

27.97%

Guinea-Pigs

30

1.13%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

51

1.92%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

48

1.8%

Goats

Sheep

28

1.05%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

2660

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2602

97.82%

Animals born in the EU but not at a registered breeder

58

2.18%

Animals born in rest of Europe

Animals born in rest of world

Total

2660

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total



Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

2212

83.16%

Translational and applied research

117

4.4%

Regulatory use and Routine production

230

8.65%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

101

3.8%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

2660

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

567

25.63%

Cardiovascular Blood and Lymphatic System

58

2.62%

Nervous System

69

3.12%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

534

24.14%

Immune System

248

11.21%

Urogenital/Reproductive System

214

9.67%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

400

18.08%

Multisystemic

122

5.52%

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

2212

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

18

15.38%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

27

23.08%

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

72

61.54%

Total

117

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Toxicity and other safety testing including pharmacology

95

41.3%

Routine production

135

58.7%

Total

230

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

40

42.11%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Target animal safety

Skin sensitisation

15

15.79%

Pharmaco-dynamics (incl safety pharmacology)

40

42.11%

Total

95

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

40

100%

Total

40

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

135

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

135

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

175

76.09%

Legislation on medicinal products for veterinary use and their residues

55

23.91%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

230

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

230

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

230

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

2660

100%

Yes

Total

2660

100.00%



Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

141

5.3%

Mild [up to and including]

1812

68.12%

Moderate

707

26.58%

Severe

Total

2660

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

2660

100%

Yes

Total

2660

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

2660

100%

Genetically altered without a harmful phenotype

0

0%

Genetically altered with a harmful phenotype

Total

2660

100.00%



Lithuania: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In 2017, there were 2766 laboratory animals used for scientific or educational purposes in Lithuania. In comparison to the previous year, ~100 more animals were used in the projects.

It was caused by the fact, that more establishments were approved and started performing projects. The number of users increased from 8 in 2013 to 12 in 2015 and to 14 in 2017.

The clearest trends in 2017 were the large increase in the use of fish for research, increase of use of farm animals (pigs) and use of animals for the purposes “Higher education or training for the acquisition, maintenance or improvement of vocational skills” and “Translational and applied research”.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The most common primary purpose for using animals was basic research (in Immune System, Oncology, Nervous System) (~ 60 %), then (~ 22 %), for the purpose “Higher education or training for the acquisition, maintenance or improvement of vocational skills” and (~ 18 %) for the purpose “Translational and applied research”.

Increase in use of animals for the purpose “Higher education or training for the acquisition, maintenance or improvement of vocational skills” is noticed from ~ 4 % to ~ 22 %. Increase of animals used for this activity was related to increased number of hospital type training centres due to active participation in international projects related to surgery training exercises.

The reason for some other changes in use of animals in any of the specific areas is that some approved establishments did not perform any projects in 2017 and other started or continued new projects in the end of the previous year.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Most part of the animals (~79 %) were used for the procedures classified as mild [up to and including] severity, (~18 %) for the procedures classified as moderate and (~ 3 %) for non-recovery severity.

Decrease in use of animals for the procedures classified as moderate and non-recovery during year 2017-2015 is related to the fact that some establishment did not perform any projects due to reconstruction of premises for some time, so more animals were used for the procedures classified as mild.

There were no exceeding of the ‘severe’ classification reported in 2017 and previous year because National Committee is encouraging users do not perform projects or organize project in such a way where animals could not be used for procedures classified as severe.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Activities undertaken under Article 47 of Directive 2010/63/EU on the protection of animals used for scientific purposes to contribute to the development, validation and promotion of alternative approaches and dissemination of information thereon at the national level for the period 2013–2015 are publically available on the webpage of the European Commission http://ec.europa.eu/environment/chemicals/lab_animals/3r/pdf/Article_47_LT.pdf

5. Further breakdown on the use of “other” categories if a significant proportion of animal use is reported under this category.

As regards the category “Other”, other birds (~ 1 %) and fish (~ 19 %) were used during the reporting period (~ 20 %) in total comparing to total amount of animals used in 2017.

The clearest trend in 2017 was the large increase in the use of fish for research. The main reason is, that new user was established and started performing projects with specific focus on fish.

Some other birds (Serinus canaria) were used.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No authorisations for projects where the 'severe' classification is exceeded were granted during the reporting period.

No exemptions under article 6(4)(a) of Directive 2010/63/EU were granted in 2017.

Lithuania: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1718

62.11%

Rats

391

14.14%

Guinea-Pigs

15

0.54%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

13

0.47%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

68

2.46%

Goats

Sheep

15

0.54%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

26

0.94%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

520

18.8%

Cephalopods

Total

2766

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2683

97%

Animals born in the EU but not at a registered breeder

83

3%

Animals born in rest of Europe

Animals born in rest of world

Total

2766

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1659

59.98%

Translational and applied research

501

18.11%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

606

21.91%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

2766

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

337

20.31%

Cardiovascular Blood and Lymphatic System

20

1.21%

Nervous System

284

17.12%

Respiratory System

103

6.21%

Gastrointestinal System including Liver

Musculoskeletal System

10

0.6%

Immune System

873

52.62%

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

32

1.93%

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

1659

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

102

20.36%

Human Cardiovascular Disorders

8

1.6%

Human Nervous and Mental Disorders

107

21.36%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

17

3.39%

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

267

53.29%

Total

501

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

2766

100%

Yes

Total

2766

100.00%



Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

83

3%

Mild [up to and including]

2186

79.03%

Moderate

497

17.97%

Severe

Total

2766

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

2766

100%

Yes

Total

2766

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

2766

100%

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

2766

100.00%



Luxembourg

Luxembourg: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

In Luxembourg an increase of about 50% of the use of animals was observed. Furthermore comparing the statistic of 2015, in 2015 the species “rat” was used in procedures.

More explanation will be indicated in part 2 of this questionnaire.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In Luxembourg the number of uses of animals increased during the last years. This trend will continue when reporting the following year (2016).

In Luxembourg two main institutions lead the laboratories and both modernised and increased their facilities during the last years. For example in 2016 a further facility was authorised, this will have a further impact on the number of animals used due to the fact of the little number of facilities (6 facilities) and the small size of the country.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2015 the first time the actual severity “severe” was reported. Initially for the concerned project the severity “mild” was prospected and consequently the responsible person stopped this project and they didn’t demanded any authorisation for modification .

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The particular efforts taken to promote the principle of the Three Rs were notably the enforcement and obligation of the training and the increased impact from the national committee.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

There is no significant proportion reported.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

During 2015 there was no case an exceedance of the ‘severe’ classification.

Luxembourg: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

3078

87.34%

Rats

73

2.07%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

373

10.58%

Other Fish

Cephalopods

Total

3524

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

3452

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

3452

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

3484

98.86%

Translational and applied research

40

1.14%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

3524

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

764

21.93%

Cardiovascular Blood and Lymphatic System

373

10.71%

Nervous System

1736

49.83%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

611

17.54%

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

3484

100.00%



Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

39

97.5%

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

1

2.5%

Total

40

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

3452

97.96%

Yes

72

2.04%

Total

3524

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

151

4.28%

Mild [up to and including]

1654

46.94%

Moderate

1679

47.64%

Severe

40

1.14%

Total

3524

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

3524

100%

Yes

Total

3524

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1721

48.84%

Genetically altered without a harmful phenotype

1657

47.02%

Genetically altered with a harmful phenotype

146

4.14%

Total

3524

100.00%



Luxembourg: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

In Luxembourg there was an increase in the total number of uses from 3.524 in 2015 to 21.472 total uses in 2016. This trend is due to the use of 17.383 zebrafish larvae between day 5-7 post fertilization.

Considering the distribution among the species, a total of 3.660 mammals were used in procedures in 2016. These figures represent an increase of 6% of the total use of mammals from 2015 to 2016.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In Luxembourg the number of uses of animals increased significantly from 3.524 uses in 2015 to a total of 21.472 uses in 2016. This trend is due to the use of 17.383 zebrafish larvae between day 5-7 post fertilization.

In Luxembourg, the two main institutions involved in animal testing both modernised and expanded their facilities during the last years. Additionally, a new facility was authorised in 2016.

Due to the small number of parties involved (6 facilities in total), this had a strong impact on the total number of animals used.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2015 the actual severity “severe” was reported the first time, when 1,14% of the uses were severe. In 2016 0,52% of the actual severities where classified as severe. As to the actual severities, no trend was observed.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics.

The particular efforts taken to promote the principle of the Three Rs were:

the focus on the education of the users,

the organisation of a workshop on the severity assessment and reporting

and additional care taken during the project evaluation.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The category “other” was not reported.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

In 2016 there was no case where the ‘severe-classification‘ has been exceeded.

Luxembourg: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

3493

16.27%

Rats

167

0.78%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

17812

82.95%

Other Fish

Cephalopods

Total

21472

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

20987

98.81%

Animals born in the EU but not at a registered breeder

253

1.19%

Animals born in rest of Europe

Animals born in rest of world

Total

21240

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

21017

97.88%

Translational and applied research

455

2.12%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

21472

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

946

4.5%

Cardiovascular Blood and Lymphatic System

429

2.04%

Nervous System

18511

88.08%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

1131

5.38%

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

21017

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

372

81.76%

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

83

18.24%

Total

455

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

First uses and re-uses

Re-use

Number of uses

Percentage

No

21240

98.92%

Yes

232

1.08%

Total

21472

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

341

1.59%

Mild [up to and including]

18628

86.75%

Moderate

2392

11.14%

Severe

111

0.52%

Total

21472

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

21472

100%

Yes

Total

21472

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

18178

84.66%

Genetically altered without a harmful phenotype

1980

9.22%

Genetically altered with a harmful phenotype

1314

6.12%

Total

21472

100.00%



Luxembourg: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In Luxembourg there was an increase in the total number of uses from 3.524 total uses in 2015, 21.472 total uses in 2016 to 25.841 total uses in 2017. This trend is due to the use of 19.410 zebrafish larvae between day 5-7 post fertilization.

Considering the distribution among the species, a total number of 5.668 mammals were used in procedures in 2017. These figures represent an increase of 54,86% of the total uses of mammals from 2016 to 2017.

Regarding the purpose of the animal uses, no trends ware observed during the last year. The main category is basic research, followed by translational and applied research, maintenance of colonies and higher education and training.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In Luxembourg the number of uses of animals increased significantly from 3.524 uses in 2015, 21.472 uses in 2016 to 25.841 total uses in 2017. This trend is due to the use of 19.410 zebrafish larvae between day 5-7 post fertilization.

In Luxembourg two main institutions are involved in animal testing. Both modernised and expanded their facilities during the last years. Additionally, a new facility was authorised in 2017.

Due to the small number of the parties involved in animal experiments (6 facilities in total), the development of the animal facilities has a strong impact on the total number of animals used. In particular the majority of the animal uses (19.410 zebrafish larvae) represent a few projects.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Comparing the actual severities from 2016 to 2017 no trend were observed.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The particular efforts taken to promote the principle of the Three Rs have been:

- The focus is put on the education of the users. Notably additional minimum requirements have been adopted for the personal involved in animal experiment,

- A workshop on the severity assessment and reporting took place,

- Refinement of the housing and care of the animals is ensured, inter alia, by modernisation of the animal facilities and by a new animal facility. Another point is the environment enrichment of the cages or aquariums, in particular, providing animals with appropriate housing that allows the expression of species-specific behaviours, such as nesting opportunities for mice.

- During the inspection attention is put on points such as that the staff follows the project protocol and in particularly that the humane endpoints are respected and the score sheets are reviewed. When procedures are conducted which involve pain or invasive procedures, it is verified that these procedures are carried out under general or local anaesthesia and that analgesia or another method is used to ensure that pain, suffering and distress are kept to a minimum.

- Additional care is taken during the project evaluation , inter alia, a review of the referenced literatures, a check of the most up to date references have been considered, a check whether there are alternative methods in place and the statistical calculation is reviewed. Regarding the alternative methods, it is checked if all measures are taken to reduce pain, suffering or lasting harms, if the humane endpoints are appropriate, if the housing, health checks of the animals are appropriate etc.

-Regarding the Reduction the national research institutes are collaborating with other research groups and are sharing data and resources (animals, tissue, organs and equipment) between research groups. Furthermore one institute owns an IRM, which enables longitudinal studies in the same animals and which is put at the disposal of the other institutes

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The category “other” was not reported.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

In 2017 there was no case where the severe-classification has been exceeded.

Luxembourg: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

5572

21.56%

Rats

96

0.37%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

20173

78.07%

Other Fish

Cephalopods

Total

25841

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

25617

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

25617

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

24562

95.05%

Translational and applied research

888

3.44%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

144

0.56%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

247

0.96%

Total

25841

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

1861

7.58%

Cardiovascular Blood and Lymphatic System

374

1.52%

Nervous System

20265

82.51%

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

2062

8.4%

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

24562

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

526

59.23%

Human Infectious Disorders

326

36.71%

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

36

4.05%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

888

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total



First uses and re-uses

Re-use

Number of uses

Percentage

No

25617

99.13%

Yes

224

0.87%

Total

25841

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

519

2.01%

Mild [up to and including]

21938

84.9%

Moderate

3213

12.43%

Severe

171

0.66%

Total

25841

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

25764

99.7%

Yes

77

0.3%

Total

25841

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

22113

85.57%

Genetically altered without a harmful phenotype

3660

14.16%

Genetically altered with a harmful phenotype

68

0.26%

Total

25841

100.00%



Malta

Malta: Narrative 2015

1.General information on any changes in trends observed since the previous reporting period.

During this year no changes have been observed in trends noted during the past years. This is due to the complete absence of scientific works involving animals.

2.Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

N/A

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

N/A

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

N/A

5.Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

N/A

6.Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

N/A

Malta: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

0

Rats

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

0

100.00%



Malta: Narrative 2016

1.General information on any changes in trends observed since the previous reporting period.

No changes have been noted from the previous year, so no animal experimentation have been carried out.

2.Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Not applicable

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

No

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

No

5.Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

N/A

6.Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

N/A

Malta: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

0

Rats

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

0

100.00%



Malta: Narrative 2017

1.General information on any changes in trends observed since the previous reporting period.

This year an application has been received by the Competent authority and the approval has been granted to carry out research on fish (sea bass).

2.Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The research program took to an increase in the number of animals used, from 0 to 250 fish.

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

No severe procedures are involved in the study carried out.

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

All the fish had to be been euthanized and incinerated.

5.Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

A significant proportion of animals is not used therefore it is not applicable

6.Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

N/A. This was an host specific parasite study interaction and did not involve severe procedures.

Malta: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

Rats

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

250

100%

Cephalopods

Total

250

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

250

100%

Animals born in rest of world

Total

250

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

Translational and applied research

250

100%

Regulatory use and Routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

250

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

250

100%

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

250

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

Total

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total



First uses and re-uses

Re-use

Number of uses

Percentage

No

250

100%

Yes

Total

250

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

Mild [up to and including]

250

100%

Moderate

Severe

Total

250

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

250

100%

Yes

Total

250

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

250

100%

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Total

250

100.00%



Netherlands

Netherlands: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

In 2014 and 2015, the Dutch collection of statistical information on the use of animals in procedures, was carried out according to the common format of Commission Implementing Decision 2012/707/EU. There are a big differences between the new data categories and the former Dutch data format. This makes it very difficult to compare the statistics of 2014 and 2015 with the data from previous years.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2015 528.159 animals were used in procedures. This is 92.868 (-14.9%) less than in 2014.

A decrease in numbers of animals has been observed in almost all data categories. Especially the number of mice (-32.701), cattle (-6.646), domestic fowl (-34.289), pigs (-4.777), rhesus monkeys (-47), and cats (-18) was reduced. In 2015 127.813 (26,7%) genetically altered animals were used in procedures, this is 17.574 (-12.1%) animals less than in 2014.

In 2015 animals were 8.514 times reused, which is 2.195 (+34.7%) more than in 2014 (6.319).

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2015 1.971 (+12.9%) more procedures were reported in the severity category ‘severe’, compared to 2014. This increase was especially seen in the categories Translational and applied research (human) (+16.5%), Animal diseases and disorders / animal welfare (+6.3%), Higher education or training for the acquisition, maintenance or improvement of vocational skills (+0.5%), and Testing by legislation/feed legislation including legislation for the safety of target animals, works and environment (+1%).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

In the Netherlands continuous efforts have been taken to promote the principles of the 3R’s. However, it is not possible to trace back these efforts to specific items in the statistics.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In Alures we have provided information on the ‘other’ categories in the required fields. Dutch users were asked to provide more information on the selected category when these information appeared to be insufficient. In some cases the users did realize that they could reclassify the animals uses in the predefined data categories. This is a continuous process of creating awareness to the authorized users.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

In 2015 exceedance of the severity classification ‘severe’ has not been reported and no exemption was authorised.

Netherlands: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

244804

51.05%

Rats

99602

20.77%

Guinea-Pigs

3433

0.72%

Hamsters (Syrian)

1518

0.32%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

1031

0.21%

Rabbits

9899

2.06%

Cats

61

0.01%

Dogs

750

0.16%

Ferrets

396

0.08%

Other carnivores

410

0.09%

Horses, donkeys and cross-breeds

213

0.04%

Pigs

8402

1.75%

Goats

239

0.05%

Sheep

2126

0.44%

Cattle

5240

1.09%

Prosimians

Marmoset and tamarins

91

0.02%

Cynomolgus monkey

47

0.01%

Rhesus monkey

96

0.02%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

14

0%

Domestic fowl

51386

10.71%

Other birds

18248

3.8%

Reptiles

851

0.18%

Rana

Xenopus

1181

0.25%

Other Amphibians

562

0.12%

Zebra fish

4909

1.02%

Other Fish

24071

5.02%

Cephalopods

Total

479580

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

378128

80.3%

Animals born in the EU but not at a registered breeder

90414

19.2%

Animals born in rest of Europe

Animals born in rest of world

2350

0.5%

Total

470892

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

166

95.4%

Animals born in rest of Europe

Animals born in Asia

8

4.6%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

174

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

3

1.72%

F2 or greater

8

4.6%

Self-sustaining colony

163

93.68%

Total

174

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

126592

26.4%

Translational and applied research

142675

29.75%

Regulatory use and Routine production

137291

28.63%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

364

0.08%

Preservation of species

1729

0.36%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

19628

4.09%

Forensic enquiries

42

0.01%

Maintenance of colonies of established genetically altered animals, not used in other procedures

51259

10.69%

Total

479580

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

36560

28.88%

Cardiovascular Blood and Lymphatic System

12259

9.68%

Nervous System

20523

16.21%

Respiratory System

1763

1.39%

Gastrointestinal System including Liver

3499

2.76%

Musculoskeletal System

1890

1.49%

Immune System

15280

12.07%

Urogenital/Reproductive System

2261

1.79%

Sensory Organs (skin, eyes and ears)

234

0.18%

Endocrine System/Metabolism

6450

5.1%

Multisystemic

3318

2.62%

Ethology / Animal Behaviour /Animal Biology

17705

13.99%

Other basic research

4850

3.83%

Total

126592

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

13203

9.25%

Human Infectious Disorders

19623

13.75%

Human Cardiovascular Disorders

4985

3.49%

Human Nervous and Mental Disorders

11760

8.24%

Human Respiratory Disorders

3942

2.76%

Human Gastrointestinal Disorders including Liver

2677

1.88%

Human Musculoskeletal Disorders

1921

1.35%

Human Immune Disorders

3075

2.16%

Human Urogenital/Reproductive Disorders

965

0.68%

Human Sensory Organ Disorders (skin, eyes and ears)

281

0.2%

Human Endocrine/Metabolism Disorders

5034

3.53%

Other Human Disorders

882

0.62%

Animal Diseases and Disorders

42449

29.75%

Animal Welfare

28642

20.07%

Diagnosis of diseases

1877

1.32%

Plant diseases

436

0.31%

Non-regulatory toxicology and ecotoxicology

923

0.65%

Total

142675

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

65122

47.43%

Other efficacy and tolerance testing

1023

0.75%

Toxicity and other safety testing including pharmacology

70723

51.51%

Routine production

423

0.31%

Total

137291

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

3162

4.86%

Other quality controls

Pyrogenicity testing

Batch potency testing

61960

95.14%

Total

65122

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1020

1.44%

Skin irritation/corrosion

316

0.45%

Skin sensitisation

3777

5.34%

Eye irritation/corrosion

85

0.12%

Repeated dose toxicity

6928

9.8%

Carcinogenicity

1538

2.17%

Genotoxicity

733

1.04%

Reproductive toxicity

23926

33.83%

Developmental toxicity

19323

27.32%

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Kinetics

986

1.39%

Ecotoxicity

9292

13.14%

Safety testing in food and feed area

960

1.36%

Target animal safety

1839

2.6%

Total

70723

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

120

11.76%

Other lethal methods

425

41.67%

Non lethal methods

475

46.57%

Total

1020

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

5024

72.52%

29 - 90 days

1904

27.48%

> 90 days

Total

6928

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

7821

84.17%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

720

7.75%

Bioaccumulation

751

8.08%

Other ecotoxicity

Total

9292

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

294

69.5%

Monoclonal antibody by mouse ascites method

Other product types

129

30.5%

Total

423

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

44052

32.09%

Legislation on medicinal products for veterinary use and their residues

33821

24.63%

Medical devices legislation

2

0%

Industrial chemicals legislation

45992

33.5%

Plant protection product legislation

2764

2.01%

Biocides legislation

Food legislation including food contact material

740

0.54%

Feed legislation including legislation for the safety of target animals, workers and environment

1045

0.76%

Cosmetics legislation

Other legislation

8875

6.46%

Total

137291

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

127695

93.01%

Legislation satisfying national requirements only [within EU]

521

0.38%

Legislation satisfying Non-EU requirements only

9075

6.61%

Total

137291

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

471066

98.22%

Yes

8514

1.78%

Total

479580

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

23323

4.86%

Mild [up to and including]

346271

72.2%

Moderate

92789

19.35%

Severe

17197

3.59%

Total

479580

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

469439

97.89%

Yes

10141

2.11%

Total

479580

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

351767

73.35%

Genetically altered without a harmful phenotype

63088

13.15%

Genetically altered with a harmful phenotype

64725

13.5%

Total

479580

100.00%

Netherlands: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period

In 2016, the Dutch registered establishments reported 403.370 animals used in procedures. This is 76.210 (-18.9%) less than in 2015. Especially the number of mice (-82.826), sheep (-1688), rabbits (-1320) and cattle (-1167) was reduced.

In 2016 animals were 10.819 times reused, which is which is 2305 more than in 2015 (8.514).

Reuse mainly takes place for the purpose of education and training.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2016, 78.209 procedures were reported with the use of genetically altered animals. This is a decrease of 49.604 animals compared to 2015. This decrease in use of genetically altered animals can partially be explained with the observation that in the previous years a large numbers of lines of genetically altered animals were established. This after completion of a welfare assessment with a minimum of two generations. For a substantial amount of genetically altered lines, it was concluded in the welfare assessment that they are not expected to have a harmful phenotype. Therefore, breeding of these lines no longer needs to be reported.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The actual severities reported in 2016 (mild 68.7%, moderate 21.7% severe 3.3%, and non-recovery: 6.3%) are generally in line with the actual severities reported in 2015 (non-recovery 4.9%, mild 72.2%, moderate 19.3% and severe 3.6%).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

In the Netherlands, continuous efforts have been taken to promote the principles of the 3R’s. However, it is not possible to trace back these efforts to specific items in the statistics.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Other carnivores (main categories): European pine marten (Martes martes), harbour seals (Phoca vitulina), European (Russian) minks (Mustela lutreola), Toepaja (Tupaia belangeri), and wild boars (Sus scrofa).

Other birds (main categories): 4803 (23.8%) Parus Major (great tit), 3654 (18.1%) Anas plathyrynchos (common mallard), 1572 (7.8%) Gallus gallus (red junglefowl), 1363 (6.8%) Limosa limosa (black tailed godwit), 1055 (5.2%) Cyanistes caeruleus (Eurasian blue tit).

Other fish (main categories): 3087 (23.8%) Anguilla Anguilla (European eel), 2909 (22.5%) Pimephales promelas (fathead minnow), 2780 (21.5%) Cyprinus carpio (common carp)

All procedures (3257) reported in de category ‘other basic research’ were used for cell biology-research.

2756 out of 5008 procedures in the category ‘other efficacy and tolerance testing’ were used for tests concerning the European pharmacopeia.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

In 2016 exceedance of the severity classification ‘severe’ has not been reported and no exemption was authorised.

Netherlands: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

148406

38.38%

Rats

106876

27.64%

Guinea-Pigs

2763

0.71%

Hamsters (Syrian)

1443

0.37%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

472

0.12%

Rabbits

8579

2.22%

Cats

89

0.02%

Dogs

656

0.17%

Ferrets

294

0.08%

Other carnivores

216

0.06%

Horses, donkeys and cross-breeds

146

0.04%

Pigs

10129

2.62%

Goats

152

0.04%

Sheep

438

0.11%

Cattle

4073

1.05%

Prosimians

Marmoset and tamarins

16

0%

Cynomolgus monkey

34

0.01%

Rhesus monkey

70

0.02%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1

0%

Domestic fowl

52237

13.51%

Other birds

20143

5.21%

Reptiles

207

0.05%

Rana

20

0.01%

Xenopus

431

0.11%

Other Amphibians

63

0.02%

Zebra fish

15804

4.09%

Other Fish

12942

3.35%

Cephalopods

Total

386700

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

288771

76.84%

Animals born in the EU but not at a registered breeder

82417

21.93%

Animals born in rest of Europe

Animals born in rest of world

4612

1.23%

Total

375800

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

58

71.6%

Animals born in rest of Europe

Animals born in Asia

23

28.4%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

81

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

25

30.86%

Self-sustaining colony

56

69.14%

Total

81

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

115211

29.79%

Translational and applied research

107466

27.79%

Regulatory use and Routine production

142733

36.91%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

24

0.01%

Preservation of species

4257

1.1%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

14714

3.81%

Forensic enquiries

677

0.18%

Maintenance of colonies of established genetically altered animals, not used in other procedures

1618

0.42%

Total

386700

100.00%



Basic Research

Basic Research

Number of uses

Percentage

Oncology

43795

38.01%

Cardiovascular Blood and Lymphatic System

7531

6.54%

Nervous System

17046

14.8%

Respiratory System

1498

1.3%

Gastrointestinal System including Liver

3351

2.91%

Musculoskeletal System

848

0.74%

Immune System

13063

11.34%

Urogenital/Reproductive System

1653

1.43%

Sensory Organs (skin, eyes and ears)

316

0.27%

Endocrine System/Metabolism

3670

3.19%

Multisystemic

3598

3.12%

Ethology / Animal Behaviour /Animal Biology

15585

13.53%

Other basic research

3257

2.83%

Total

115211

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

14122

13.14%

Human Infectious Disorders

18775

17.47%

Human Cardiovascular Disorders

4564

4.25%

Human Nervous and Mental Disorders

9646

8.98%

Human Respiratory Disorders

2664

2.48%

Human Gastrointestinal Disorders including Liver

2186

2.03%

Human Musculoskeletal Disorders

917

0.85%

Human Immune Disorders

2024

1.88%

Human Urogenital/Reproductive Disorders

107

0.1%

Human Sensory Organ Disorders (skin, eyes and ears)

430

0.4%

Human Endocrine/Metabolism Disorders

2444

2.27%

Other Human Disorders

30

0.03%

Animal Diseases and Disorders

18186

16.92%

Animal Welfare

29363

27.32%

Diagnosis of diseases

1339

1.25%

Plant diseases

43

0.04%

Non-regulatory toxicology and ecotoxicology

626

0.58%

Total

107466

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

54947

38.5%

Other efficacy and tolerance testing

5008

3.51%

Toxicity and other safety testing including pharmacology

82616

57.88%

Routine production

162

0.11%

Total

142733

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

2603

4.74%

Pyrogenicity testing

Batch potency testing

52206

95.01%

Other quality controls

138

0.25%

Total

54947

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1903

2.3%

Skin irritation/corrosion

124

0.15%

Skin sensitisation

4086

4.95%

Eye irritation/corrosion

107

0.13%

Repeated dose toxicity

6386

7.73%

Carcinogenicity

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Genotoxicity

660

0.8%

Reproductive toxicity

25780

31.2%

Developmental toxicity

35853

43.4%

Kinetics

1001

1.21%

Ecotoxicity

4917

5.95%

Safety testing in food and feed area

1792

2.17%

Target animal safety

7

0.01%

Total

82616

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

112

5.89%

Non lethal methods

1791

94.11%

Total

1903

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

2047

32.05%

29 - 90 days

3679

57.61%

> 90 days

660

10.34%

Total

6386

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3777

76.82%

Chronic toxicity

Reproductive ecotoxicity

240

4.88%

Endocrine activity

Bioaccumulation

900

18.3%

Other ecotoxicity

Total

4917

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

2

1.23%

Monoclonal antibody by mouse ascites method

Other product types

160

98.77%

Total

162

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

38543

27%

Legislation on medicinal products for veterinary use and their residues

30184

21.15%

Medical devices legislation

62

0.04%

Industrial chemicals legislation

68172

47.76%

Plant protection product legislation

310

0.22%

Biocides legislation

86

0.06%

Food legislation including food contact material

438

0.31%

Feed legislation including legislation for the safety of target animals, workers and environment

2182

1.53%

Cosmetics legislation

Other legislation

2756

1.93%

Total

142733

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

140100

98.16%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

2633

1.84%

Total

142733

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

375881

97.2%

Yes

10819

2.8%

Total

386700

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

8732

2.26%

Mild [up to and including]

277205

71.68%

Moderate

87429

22.61%

Severe

13334

3.45%

Total

386700

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

378070

97.77%

Yes

8630

2.23%

Total

386700

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

308491

79.78%

Genetically altered without a harmful phenotype

67451

17.44%

Genetically altered with a harmful phenotype

10758

2.78%

Total

386700

100.00%



Netherlands: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period

In 2017, the Dutch registered establishments reported 477.550 animals used in procedures. This is 74.180 (+18.4%) more than in 2016. Especially the number of mice (+44.015), and zebrafish (+36.220) was increased. The number of rats (-18.052) was reduced.

In 2017 animals were 11.138 times reused, which is 319 animal more than in 2016 (10.819). Reuse mainly takes place for the purpose of education and training.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2017 more experiments with zebrafish were carried out in the context of intensifying research into new possibilities for the screening of anti-cancer drugs. In addition, more experiments with zebrafish have been carried out as a result of research into hormone-disrupting substances in the context of a larger EU project.

In 2017, 133.365 procedures were reported with the use of genetically altered animals. This is a increase of 55.156 animals compared to 2016. Most animal testing on genetically modified animals have carried out on mice (84,908, 63.7% of the number of animal tests for genetically modified animals animals) and zebrafish (45,941, 34.4%).

After a significant increase in number of animal uses in 2014 and a temporary decrease in 2016, the number of animals uses appears to be stabilizing in 2017 and has reached the same level as in the reporting years 2013 and 2015. These fluctuations seem to be caused mainly by the adaptation of the user community to the new reporting and licensing system, introduced in 2014.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The actual severities reported in 2017 (mild 64,9%, moderate 25,5%, severe 3.0%, and non-recovery: 6.6%) are generally in line with the actual severities reported in 2016 (mild 68.7%, moderate 21.7%, severe 3.3%, and non-recovery 6.3%).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

In the Netherlands, continuous efforts have been taken to promote the principles of the 3R’s. However, it is not possible to trace back these efforts to specific items in the statistics.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Other carnivores (main categories): 257 European (Russian) minks (Mustela lutreola), 6 harbour seals (Phoca vitulina), 6 badgers (Meles meles), and 2 European pine marten (Martes martes).

Other birds (main categories): 4618 Parus Major (great tit), 3822 Anas plathyrynchos (common mallard), 3160 Gallus gallus (red junglefowl), 1580 Limosa limosa (black tailed godwit).

Other fish (main categories): 5318 Pleuronectes platessa (European plaice), 4467 Anguilla Anguilla (European eel), 3571 Limanda limanda (common dab).

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

In 2017 exceedance of the severity classification ‘severe’ has not been reported and no exemption was authorised.

Netherlands: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

205993

43.14%

Rats

91537

19.17%

Guinea-Pigs

5816

1.22%

Hamsters (Syrian)

1035

0.22%

Hamsters (Chinese)

12

0%

Mongolian gerbil

Other Rodents

736

0.15%

Rabbits

9764

2.04%

Cats

200

0.04%

Dogs

909

0.19%

Ferrets

680

0.14%

Other carnivores

270

0.06%

Horses, donkeys and cross-breeds

173

0.04%

Pigs

9738

2.04%

Goats

259

0.05%

Sheep

558

0.12%

Cattle

3833

0.8%

Prosimians

Marmoset and tamarins

41

0.01%

Cynomolgus monkey

42

0.01%

Rhesus monkey

234

0.05%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

3315

0.69%

Domestic fowl

55371

11.59%

Other birds

18322

3.84%

Reptiles

294

0.06%

Rana

9

0%

Xenopus

438

0.09%

Other Amphibians

60

0.01%

Zebra fish

52024

10.89%

Other Fish

15887

3.33%

Cephalopods

Total

477550

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

363141

77.89%

Animals born in the EU but not at a registered breeder

94773

20.33%

Animals born in rest of Europe

44

0.01%

Animals born in rest of world

8263

1.77%

Total

466221

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

189

98.95%

Animals born in rest of Europe

Animals born in Asia

2

1.05%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

191

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

2

1.05%

Self-sustaining colony

189

98.95%

Total

191

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

199245

41.72%

Translational and applied research

127385

26.67%

Regulatory use and Routine production

122247

25.6%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

873

0.18%

Preservation of species

3698

0.77%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

22074

4.62%

Forensic enquiries

361

0.08%

Maintenance of colonies of established genetically altered animals, not used in other procedures

1667

0.35%

Total

477550

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

94460

47.41%

Cardiovascular Blood and Lymphatic System

6868

3.45%

Nervous System

18175

9.12%

Respiratory System

758

0.38%

Gastrointestinal System including Liver

3203

1.61%

Musculoskeletal System

692

0.35%

Immune System

16582

8.32%

Urogenital/Reproductive System

1199

0.6%

Sensory Organs (skin, eyes and ears)

1030

0.52%

Endocrine System/Metabolism

4351

2.18%

Multisystemic

4115

2.07%

Ethology / Animal Behaviour /Animal Biology

20617

10.35%

Other basic research

27195

13.65%

Total

199245

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

13920

10.93%

Human Infectious Disorders

22913

17.99%

Human Cardiovascular Disorders

5882

4.62%

Human Nervous and Mental Disorders

9692

7.61%

Human Respiratory Disorders

2410

1.89%

Human Gastrointestinal Disorders including Liver

2555

2.01%

Human Musculoskeletal Disorders

1587

1.25%

Human Immune Disorders

4179

3.28%

Human Urogenital/Reproductive Disorders

814

0.64%

Human Sensory Organ Disorders (skin, eyes and ears)

575

0.45%

Human Endocrine/Metabolism Disorders

2423

1.9%

Other Human Disorders

235

0.18%

Animal Diseases and Disorders

31368

24.62%

Animal Welfare

22221

17.44%

Diagnosis of diseases

1115

0.88%

Plant diseases

8

0.01%

Non-regulatory toxicology and ecotoxicology

5488

4.31%

Total

127385

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

50082

40.97%

Other efficacy and tolerance testing

3235

2.65%

Toxicity and other safety testing including pharmacology

68753

56.24%

Routine production

177

0.14%

Total

122247

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1948

3.89%

Pyrogenicity testing

Batch potency testing

47934

95.71%

Other quality controls

200

0.4%

Total

50082

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1886

2.74%

Skin irritation/corrosion

47

0.07%

Skin sensitisation

2378

3.46%

Eye irritation/corrosion

59

0.09%

Repeated dose toxicity

8739

12.71%

Carcinogenicity

Neurotoxicity

Other toxicity/safety testing

Genotoxicity

106

0.15%

Reproductive toxicity

36568

53.19%

Developmental toxicity

9944

14.46%

Kinetics

1635

2.38%

Pharmaco-dynamics (incl safety pharmacology)

8

0.01%

Phototoxicity

4

0.01%

Ecotoxicity

4101

5.96%

Safety testing in food and feed area

2104

3.06%

Target animal safety

1174

1.71%

Total

68753

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

1886

100%

Total

1886

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

3875

44.34%

29 - 90 days

4131

47.27%

> 90 days

733

8.39%

Total

8739

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

1368

33.36%

Chronic toxicity

2329

56.79%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

404

9.85%

Other ecotoxicity

Total

4101

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

6

3.39%

Monoclonal antibody by mouse ascites method

Other product types

171

96.61%

Total

177

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

30227

24.73%

Legislation on medicinal products for veterinary use and their residues

31915

26.11%

Medical devices legislation

Industrial chemicals legislation

57024

46.65%

Plant protection product legislation

312

0.26%

Biocides legislation

92

0.08%

Food legislation including food contact material

447

0.37%

Feed legislation including legislation for the safety of target animals, workers and environment

2164

1.77%

Cosmetics legislation

Other legislation

66

0.05%

Total

122247

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

119545

97.79%

Legislation satisfying national requirements only [within EU]

8

0.01%

Legislation satisfying Non-EU requirements only

2694

2.2%

Total

122247

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

466412

97.67%

Yes

11138

2.33%

Total

477550

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

31611

6.62%

Mild [up to and including]

310002

64.92%

Moderate

121739

25.49%

Severe

14198

2.97%

Total

477550

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

466582

97.7%

Yes

10968

2.3%

Total

477550

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

344185

72.07%

Genetically altered without a harmful phenotype

123939

25.95%

Genetically altered with a harmful phenotype

9426

1.97%

Total

477550

100.00%



Poland

Poland: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

The report is the first submitted under the new rules.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The report is the first submitted under the new rules.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The report is the first submitted under the new rules.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Propagation and awareness of the need for replacement, reduction and refinement (3R) is one of the primary aims Polish National Ethics Committee on Animal Experimentation and is governed by a legal act of the highest importance, the Act on Experiments on Animals of 15 January 2015, in accordance to the Directive 2010/63/EU on the protection of animals used for scientific purposes.

Propagation of list of alternative methods designed to replace some routine animal tests and reduction of number of animals in routine testing is accessible at the webpage of the Committee.

Application of alternative methods to replace animals from routine tests is one of the major criteria in assessment of animal study applications by the Local Ethics Committees in Poland. Description of replacement, reduction and refinement application is also an indispensable part of each application.

The Committee supports the 3R courses for scientists and caretakers, which are obligatory to receive any permission to perform or plan experiments. All these issues are also propagate during the meetings organized with the local committees and disseminate to the bodies on animal welfare, which operate in all breeders, suppliers and users.  At the webpage of the Committee there are documents concerning 3R rules prepared by European Commission and the guides prepared by the Committee describing how to assess the invasiveness procedures and how to make them milder to animals. All these documents are publicly accessible.

In our opinion, it is too early to assess its impacts on statistics. 

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In the 2015 report under the category "other animals" there are:

·Other carnivores (other Carnivora) are Meles meles, Mustela nivalis, Neovison vison, Nyctereutes procyonoides, Ursus arctos, Vulpes vulpes used in the purposes of Ethology / Animal Behaviour /Animal Biology, Protection of the natural environment in the interests of the health or welfare of human beings or animals. They represent 96,24 % of all carnivores.

·Other birds (other Aves) are Acrocephalus schoenobaenus, Actitis hypoleucos, Anas platyrhynchos, Calidris alba, Calidris ferruginea, Calidris canutus, Canistes caerules, Chlidonias hybrida, Chroicocephalus ridibundus, Ciconia ciconia, Cisticola chubbi, Coturnix japonica, Columba livia, Cyanistes caeruleus, Dromaiinae, Emberiza hortulana, Falco peregrinus, Fulica atra, Gerygone flavolateralis, Hirundo rustica, Laniarus atroflavus, Larus canus, Meleagris gallopavo gallopavo var. Domesticus, Passer domesticus, Parus major, Remiz pendulinus, Sternula albiforns, Sterna hirundo, Sylvia communis, Turdus philomelos, Taeniopygia guttata, , Turdus merula used in the purposes of Ethology / Animal Behaviour /Animal Biology, Protection of the natural environment in the interests of the health or welfare of human beings or animals, Higher education or training for the acquisition, maintenance or improvement of vocational skills. They represent 34,31% of all birds.

·Other fish (other Pisces) are Acipenser baeri, Acipenser guldenstaedtii, Acipenser ruthenus, Anguilla anguilla, Babka gymnotrachelus, Carassius carassius, Cobitis taenia, Coregonus lavaretus, Cyprinus carpio, Gasterosteus aculeatus, Leuciscus idus, Neogobius melanostomus, Oncorhynchus mykiss, Perca fluviatilis, Perccottus glenii, Platichthys flesus, Poecilia reticulata, Poecilia sphenops, Proterorhinus semilunaris, Rutilus rutilus, Salmo trutta, Salmonidae, Sander lucioperca, Scardinius erythrophthalmus, Silurus glanis, Tinca tinca used in the purposes of (Regulatory use/Toxicity and../Ecotoxicity) Acute toxicity, (Basic Research) Immune System, (Basic Research) Ethology / Animal Behaviour /Animal Biology, Protection of the natural environment in the interests of the health or welfare of human beings or animals, (Basic Research) Urogenital/Reproductive System, (Trans/Appl Research) Non-regulatory toxicology and ecotoxicology, Higher education or training for the acquisition, maintenance or improvement of vocational skills, Preservation of species, (Basic Research) Multisystemic , (Trans/Appl Research) Animal Welfare. They represent 94,85 % of all fish.

·Other amphibians (other Amphibia) are Bufo bufo, Pelophylax esculentus, Pelophylax lessonae, Pelophylax ridibundus, Slalamandra salamandra, used in the purposes of Basic Research: Urogenital/Reproductive System and Ethology / Animal Behaviour /Animal Biology. They represent 36,7 % of all amphibians.

In Regulatory use / Routine production as „Other” are specified medicinal products and quality controls.

In Regulatory use as „Other efficacy and tolerance testing” are specified study of local tolerance and study of skin sensitization.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

There are no such cases.

Poland: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

88776

50.16%

Rats

36073

20.38%

Guinea-Pigs

5756

3.25%

Hamsters (Syrian)

22

0.01%

Hamsters (Chinese)

Mongolian gerbil

178

0.1%

Other Rodents

8445

4.77%

Rabbits

1606

0.91%

Cats

8

0%

Dogs

24

0.01%

Ferrets

Other carnivores

818

0.46%

Horses, donkeys and cross-breeds

232

0.13%

Pigs

1718

0.97%

Goats

8

0%

Sheep

566

0.32%

Cattle

1637

0.92%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1195

0.68%

Domestic fowl

11099

6.27%

Other birds

5798

3.28%

Reptiles

110

0.06%

Rana

224

0.13%

Xenopus

102

0.06%

Other Amphibians

189

0.11%

Zebra fish

639

0.36%

Other Fish

11757

6.64%

Cephalopods

Total

176980

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

145779

83.75%

Animals born in the EU but not at a registered breeder

27864

16.01%

Animals born in rest of Europe

21

0.01%

Animals born in rest of world

398

0.23%

Total

174062

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

126089

71.24%

Translational and applied research

14826

8.38%

Regulatory use and Routine production

29475

16.65%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

3126

1.77%

Preservation of species

664

0.38%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2688

1.52%

Forensic enquiries

100

0.06%

Maintenance of colonies of established genetically altered animals, not used in other procedures

12

0.01%

Total

176980

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

9925

7.87%

Cardiovascular Blood and Lymphatic System

7537

5.98%

Nervous System

53294

42.27%

Respiratory System

236

0.19%

Gastrointestinal System including Liver

4076

3.23%

Musculoskeletal System

1107

0.88%

Immune System

6579

5.22%

Urogenital/Reproductive System

5662

4.49%

Sensory Organs (skin, eyes and ears)

495

0.39%

Endocrine System/Metabolism

3322

2.63%

Multisystemic

15835

12.56%

Ethology / Animal Behaviour /Animal Biology

6463

5.13%

Other basic research

11558

9.17%

Total

126089

100.00%



Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

2906

19.6%

Human Infectious Disorders

468

3.16%

Human Cardiovascular Disorders

207

1.4%

Human Nervous and Mental Disorders

2399

16.18%

Human Respiratory Disorders

80

0.54%

Human Gastrointestinal Disorders including Liver

244

1.65%

Human Musculoskeletal Disorders

164

1.11%

Human Immune Disorders

338

2.28%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

410

2.77%

Human Endocrine/Metabolism Disorders

96

0.65%

Other Human Disorders

429

2.89%

Animal Diseases and Disorders

1642

11.08%

Animal Welfare

2418

16.31%

Diagnosis of diseases

577

3.89%

Plant diseases

Non-regulatory toxicology and ecotoxicology

2448

16.51%

Total

14826

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

16708

56.69%

Other efficacy and tolerance testing

36

0.12%

Toxicity and other safety testing including pharmacology

11766

39.92%

Routine production

965

3.27%

Total

29475

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

4710

28.19%

Pyrogenicity testing

234

1.4%

Batch potency testing

10089

60.38%

Other quality controls

1675

10.03%

Total

16708

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

5385

45.77%

Skin irritation/corrosion

259

2.2%

Skin sensitisation

1284

10.91%

Eye irritation/corrosion

50

0.42%

Repeated dose toxicity

183

1.56%

Carcinogenicity

140

1.19%

Developmental toxicity

Genotoxicity

Kinetics

Phototoxicity

Safety testing in food and feed area

Target animal safety

Reproductive toxicity

1425

12.11%

Neurotoxicity

142

1.21%

Pharmaco-dynamics (incl safety pharmacology)

164

1.39%

Ecotoxicity

2718

23.1%

Other toxicity/safety testing

16

0.14%

Total

11766

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

4525

84.03%

Other lethal methods

Non lethal methods

860

15.97%

Total

5385

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

183

100%

29 - 90 days

> 90 days

Total

183

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

2718

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

2718

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

383

39.69%

Monoclonal antibody by mouse ascites method

Other product types

582

60.31%

Total

965

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

19733

66.95%

Legislation on medicinal products for veterinary use and their residues

3025

10.26%

Medical devices legislation

867

2.94%

Industrial chemicals legislation

2022

6.86%

Plant protection product legislation

3150

10.69%

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

12

0.04%

Cosmetics legislation

Other legislation

666

2.26%

Total

29475

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

28709

97.4%

Legislation satisfying national requirements only [within EU]

607

2.06%

Legislation satisfying Non-EU requirements only

159

0.54%

Total

29475

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

174062

98.35%

Yes

2918

1.65%

Total

176980

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

16523

9.34%

Mild [up to and including]

67288

38.02%

Moderate

64396

36.39%

Severe

28773

16.26%

Total

176980

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

176187

99.55%

Yes

793

0.45%

Total

176980

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

166850

94.28%

Genetically altered without a harmful phenotype

6489

3.67%

Genetically altered with a harmful phenotype

3641

2.06%

Total

176980

100.00%



Poland: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

The 2016 report is only the second one made in accordance with the new rules. This makes it impossible to identify real trends in the use of animals for experiments. In addition, the drawing of general conclusions is made difficult by the ongoing transitional period in Poland, during which experiments are being carried out both in accordance with provisions that have already been repealed (up to the end of 2017) and the law currently in force. On the one hand, this has resulted in an increase in the number of animals used, due to rapidly completed ‘old’ experiments. On the other hand, some experiments which are not considered procedures under the new rules continue to take place (and be reported). The reports for 2015 could also contain errors resulting from a misunderstanding of the new rules and reporting rules. Users’ awareness is increasing thanks to numerous training courses held in 2015-2016 and other forms of disseminating information, with the consequence that subsequent reports are correct and more consistent.

2. Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

The observed differences in the number of animals used in each area, as reflected in the 2015 and 2016 reports, may be the consequence of the trends described above. In addition, they seem to be a natural consequence of completing one type of experiment and starting another, in connection with seeking research grants linked to an increase in the popularity of a given field of research or, for example, to seeking orders from external parties.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2016, a clear decline is observed in the number of mice used in ‘non-recovery’ experiments. This is probably due to an earlier misunderstanding of the concept by users, and also the exhausting of authorisations issued on the basis of the repealed Act. Animals were also likely to be included in this category in 2015 for the sole purpose of the procurement of organs and tissues, since, according to the previous legislation, the consent of the Local Ethics Committee on Animal Experiments (LEC) was also required in the event that an animal was killed for such purposes. Certainty of the accuracy of the data reported was only achieved in the subsequent report for 2016.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The statutory objectives of the National Ethics Committee on Animal Experiments (NEC) are action for the three Rs and the promotion of alternative research. The NEC supports training courses for persons planning or carrying out experiments whose programmes incorporate this topic. It also communicates the above information to LECs and welfare teams through direct contacts as well as via its website.

When issuing authorisation for carrying out an experiment, LECs are required to take into account the existence of alternative methods and the application of the three Rs. To this end, the model request for authorisation contains a specific field where the user is required to enter the method of implementation of the three Rs in the experiment. The special welfare teams that users are obliged by law to set up monitor the means of implementing the three Rs in individual units. Their activities are monitored by the NEC, which prepares a comprehensive analysis of users’ reporting in this area on an annual basis.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In Poland a large number of nutritional experiments are carried out in which the activities performed fall within the definition of a procedure. However, in the reporting table there is no separate category for nutritional tests in the list of objectives, hence these are placed in the ‘other’ group. A similar situation arises in the case of procedures involving the transfer of embryos. There is also one unit which, under routine manufacturing procedures required by law, employs tests other than those on the list to test medicinal products from material of plant origin (API).

In 2016, the animal species included in the ‘other’ category were:

·‘Other’ species of carnivore (other Carnivora), namely Mustela nivalis and

Neovison vison. These are used in fundamental research relating to biology and species behaviour and translational research on animal welfare. They account for 18.25% of all carnivorous animal species used in research.

· ‘Other’ bird species (other Aves), namely Acrocephalus arundinaceus, Acrocephalus dumetorum, Acrocephalus palustris, Acrocephalus schoenobaenus, Acrocephalus scirpaceus, Actitis hypoleucos, Anas platyrhynchos, Anser domesticus, Calidris alba, Calidris ferruginea, Canistes caerules, Chlidonias hybrid, Columba livia, Coturnix japonica, Cyanistes caeruleus, Dromaiinae, Ficedula hypoleuca, Fringilla coelebs, Hippolais icterina, Hirundo rustica, Lanius collurio, Larus canus, Locustella fluviatilis, Locustella luscinioides, Locustella naevia, Meleagris gallopavo gallopavo var. domesticus, Passer domesticus, Parus major, Remiz pendulinus, Sterna albifrons, Sterna hirundo, Sylvia borin, Sylvia communis, Sylvia curruca, Sylvia nisoria, Tetrao urogallus, Turdus merula and Turdus philomelos. These are mainly used in fundamental research relating to biology and species behaviour, tests of gastrointestinal systems, including liver and multisystemic tests, and translational research on animal welfare, animal diseases and disorders and the conservation of the species in nature. They account for 66.61% of all bird species used in research.

·‘Other’ fish species (other Pisces), namely Acipenser baeri, Acipenser ruthenus, Anguilla anguilla, Babka gymnotrachelus, Barbus barbus, Carassius auratus, Carassius carassius, Carassius gibelio, Chondrostoma nasus, Clarias gariepinus, Cobitis taenia, Cobitis elongatoides, Cobitis hybrids, Coregonus albula, Coregonus lavaretus, Cyprinus carpio, Esox lucius, Gasterosteus aculeatus, Gymnocephalus cernua, Neogobius fluviatilis, Neogobius melanostomus, Oncorhynchus mykiss, Perca fluviatilis, Perccottus glenii, Poecilia reticulate, Platichthys flesus, Proterorhinus semilunaris, Rutilus rutilus, Salmo trutta m. trutta, Sander lucioperca, Scardinius erythrophthalmus, Silurus glanis, Squalius cephalus and Tinca tinca. These are mainly used in fundamental research relating to biology and species behaviour, tests of immune systems, reproductive systems and multisystemic tests, translational research on animal welfare, animal diseases and disorders and the conservation of the species in nature, but also in some acute toxicity studies. They account for 97.16% of all fish species used in research.

·‘Other’ amphibian species (other Amphibia), namely Bufo bufo, Pelophylax esculentus, Pelophylax lessonae, Pelophylax ridibundus and Slalamandra salamandra. These are used in fundamental research relating to biology and species behaviour and reproductive system tests, and translational research on animal diseases and disorders. They account for 97.32% of all amphibian species used in research.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No such cases were found. It appears that more complete information in this regard can be provided through retrospective evaluations carried out by local ethics committees.

Poland: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

89105

47.22%

Rats

32370

17.15%

Guinea-Pigs

6639

3.52%

Hamsters (Syrian)

212

0.11%

Hamsters (Chinese)

Mongolian gerbil

88

0.05%

Other Rodents

1263

0.67%

Rabbits

998

0.53%

Cats

15

0.01%

Dogs

88

0.05%

Ferrets

Other carnivores

23

0.01%

Horses, donkeys and cross-breeds

220

0.12%

Pigs

1068

0.57%

Goats

36

0.02%

Sheep

1143

0.61%

Cattle

492

0.26%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

578

0.31%

Domestic fowl

3612

1.91%

Other birds

7207

3.82%

Reptiles

526

0.28%

Rana

20

0.01%

Xenopus

Other Amphibians

727

0.39%

Zebra fish

1203

0.64%

Other Fish

41086

21.77%

Cephalopods

Total

188719

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

129825

69.26%

Animals born in the EU but not at a registered breeder

57519

30.69%

Animals born in rest of Europe

Animals born in rest of world

104

0.06%

Total

187448

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

142463

75.49%

Translational and applied research

17140

9.08%

Regulatory use and Routine production

26157

13.86%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

321

0.17%

Preservation of species

893

0.47%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1597

0.85%

Forensic enquiries

30

0.02%

Maintenance of colonies of established genetically altered animals, not used in other procedures

118

0.06%

Total

188719

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

7378

5.18%

Cardiovascular Blood and Lymphatic System

5558

3.9%

Nervous System

52700

36.99%

Respiratory System

134

0.09%

Gastrointestinal System including Liver

5032

3.53%

Musculoskeletal System

843

0.59%

Immune System

6012

4.22%

Urogenital/Reproductive System

3597

2.52%

Sensory Organs (skin, eyes and ears)

193

0.14%

Endocrine System/Metabolism

7697

5.4%

Multisystemic

7232

5.08%

Ethology / Animal Behaviour /Animal Biology

40710

28.58%

Other basic research

5377

3.77%

Total

142463

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

5061

29.53%

Human Infectious Disorders

1207

7.04%

Human Cardiovascular Disorders

505

2.95%

Human Nervous and Mental Disorders

2261

13.19%

Human Respiratory Disorders

10

0.06%

Human Gastrointestinal Disorders including Liver

160

0.93%

Human Musculoskeletal Disorders

70

0.41%

Human Immune Disorders

115

0.67%

Human Urogenital/Reproductive Disorders

31

0.18%

Human Sensory Organ Disorders (skin, eyes and ears)

178

1.04%

Human Endocrine/Metabolism Disorders

Other Human Disorders

30

0.18%

Animal Diseases and Disorders

398

2.32%

Animal Welfare

3287

19.18%

Diagnosis of diseases

3325

19.4%

Plant diseases

Non-regulatory toxicology and ecotoxicology

502

2.93%

Total

17140

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

18221

69.66%

Other efficacy and tolerance testing

363

1.39%

Toxicity and other safety testing including pharmacology

7261

27.76%

Routine production

312

1.19%

Total

26157

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

3876

21.27%

Pyrogenicity testing

202

1.11%

Batch potency testing

13177

72.32%

Other quality controls

966

5.3%

Total

18221

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1721

23.7%

Skin irritation/corrosion

195

2.69%

Skin sensitisation

1571

21.64%

Eye irritation/corrosion

50

0.69%

Repeated dose toxicity

120

1.65%

Carcinogenicity

Genotoxicity

Neurotoxicity

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Target animal safety

Developmental toxicity

164

2.26%

Kinetics

40

0.55%

Pharmaco-dynamics (incl safety pharmacology)

38

0.52%

Ecotoxicity

3338

45.97%

Other toxicity/safety testing

24

0.33%

Total

7261

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

371

21.56%

Other lethal methods

Non lethal methods

1350

78.44%

Total

1721

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

120

100%

> 90 days

Total

120

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3123

93.56%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

215

6.44%

Total

3338

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

312

100%

Total

312

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

18178

69.5%

Legislation on medicinal products for veterinary use and their residues

2651

10.13%

Medical devices legislation

310

1.19%

Industrial chemicals legislation

265

1.01%

Plant protection product legislation

4597

17.57%

Biocides legislation

122

0.47%

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

34

0.13%

Cosmetics legislation

Other legislation

Total

26157

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

25604

97.89%

Legislation satisfying national requirements only [within EU]

487

1.86%

Legislation satisfying Non-EU requirements only

66

0.25%

Total

26157

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

187448

99.33%

Yes

1271

0.67%

Total

188719

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

7963

4.22%

Mild [up to and including]

87965

46.61%

Moderate

47593

25.22%

Severe

45198

23.95%

Total

188719

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

188426

99.84%

Yes

293

0.16%

Total

188719

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

180608

95.7%

Genetically altered without a harmful phenotype

5577

2.96%

Genetically altered with a harmful phenotype

2534

1.34%

Total

188719

100.00%



Poland: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

The drawing of general conclusions is made difficult by the ongoing transitional period in Poland, during which experiments are being carried out both in accordance with provisions that have already been repealed (up to the end of 2017) and the law currently in force. This is the case because some experiments which are not considered procedures under the new rules continue to take place and be reported. Despite this, the number of animals used decreased markedly in 2017. Thanks to the training provided, a better understanding can be seen of the definition of a procedure and the reporting rules, resulting in the more precise identification of animal numbers. One example is that the number of fish other than zebrafish used in 2017 fell significantly.

A steady and significant decrease was also noted in the number of animals reused.

2. Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

The observed variation in the number of animals used of certain species seems to be a natural consequence of completing one type of experiment and starting another, in connection with seeking research grants linked to an increase in the popularity of a given field of research or, for example, to seeking orders from external parties. One good example is the appearance in 2017 of a group of 17 monkeys from Ceboidea and Cercopitecoidea species used in connection with a single experiment on their behaviour in zoo conditions. It is also likely that single experiments on dogs and horses ended in 2017 for this same reason, and the number of dogs and horses used therefore decreased significantly.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2017, a decrease is observed in the number of rats used in ‘non-recovery’ experiments. This is probably due to an earlier misunderstanding of the concept by users, and also the exhausting of authorisations issued on the basis of the repealed Act. Animals were also likely to be included in this category in 2015 for the sole purpose of the procurement of organs and tissues, since, according to the previous legislation, the consent of the Local Ethics Committee on Animal Experiments (LEC) was also required in the event that an animal was killed for such purposes.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The statutory objectives of the National Ethics Committee on Animal Experiments (NEC) are action for the three Rs and the promotion of alternative research. The NEC supports training courses for persons planning or carrying out experiments whose programmes incorporate this topic. It also communicates the above information to LECs and welfare teams through direct contacts as well as via its website, and organises training for LECs once per year.

When issuing authorisation for carrying out an experiment, LECs are required to take into account the existence of alternative methods and the application of the three Rs. To this end, the model request for authorisation contains a specific field where the user is required to enter the method of implementation of the three Rs in the experiment. The special welfare teams that users are obliged to set up by law monitor the means of implementing the three Rs in individual units. Their activities are monitored by the NEC, which prepares a comprehensive analysis of users’ reporting in this area on an annual basis.

In 2017 the NEC also took the initiative to organise a cooperation network between units and bodies involved in the implementation of alternative methods.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In Poland a large number of nutritional experiments are carried out in which the activities performed fall within the definition of a procedure. However, in the reporting table there is no separate category for nutritional tests in the list of objectives, hence these are placed in the ‘other’ group. A similar situation arises in the case of procedures involving the transfer of embryos. There is also one unit which, under routine manufacturing procedures required by law, employs tests other than those on the list to test medicinal products from material of plant origin (API).

In 2017, the animal species included in the ‘other’ category were:

·‘Other’ species of carnivore (other Carnivora), namely Mustela nivalis and Mustela lutreola. These are used mainly in fundamental research relating to biology and species behaviour. They account for 92.86% of all carnivorous animal species used in research.

· ‘Other’ bird species (other Aves), namely Acrocephalus paludicola, Acrocephalus schoenobaenus, Actitis hypoleucos, Anas platyrhynchos, Anser domesticus, Calidris alba, Calidris alpine, Calidris canutus, Calidris falcinellus, Calidris ferruginea, Calidris minuta, Calidris pugnax, Charadrius dubius, Charadrius hiaticula, Chlidonias hybrida, Chroicocephalus ridibundus, Ciconia ciconia, Columba livia, Coturnix japonica, Cyanistes caeruleus, Cygnus olor, Ficedula hypoleuca, Fringilla coelebs, Fulica atra, Gallinago gallinago, Haliaeetus albicilla, Hirundo rustica, Meleagris gallopavo, Motacilla alba, Motacilla flava, Lanius collurio, Larus canus, Parus major, Passer domesticus, Passer montanus, Phasianus colchicus, Serinus canaria, Sterna hirundo, Taeniopygia guttata, Tetrao urogallus, Tringa erythropus, Tringa glareola, Tringa nebularia, Tringa ochropus, Tringa totanus, Turdus merula and Vanellus vanellus. These are mainly used in fundamental research relating to biology and species behaviour, tests of the immune and reproductive systems, and translational research on animal welfare, animal diseases and disorders and the conservation of the species in nature. They account for 56.44% of all bird species used in research.

·‘Other’ fish species (other Pisces), namely Acipenser baeri, Acipenser gueldenstadtii, Acipenser ruthenus, Babka gymnotrachelus, Coregonus lavaretus, Cottus gobio, Cyprinus carpio, Eudontomyzon mariae, Gobio gobio, Lampetra planeri, Neogobius fluviatilis, Oncorhynchus mykiss, Perca fluviatilis, Poecilia reticulata, Proterorhinus semilunaris, Rutilus rutilus, Sander lucioperca and Scardinius erythrophthalmus. These are mainly used in fundamental research relating to biology and species behaviour, tests of the immune and reproductive systems, and translational research on animal welfare, animal diseases and disorders, and also in some acute toxicity studies. They account for 84.99% of all fish species used in research.

·‘Other’ amphibian species (other Amphibia), namely Bufotes viridis in the adult and larval stages, Pelophylax esculentus, Pelophylax lessonae, Pelophylax ridibundus. These are mainly used in fundamental research relating to reproductive and metabolism studies, and translational research on animal diseases and disorders, as well as population genetics and phylogeography. They account for 95.8% of all amphibian species used in research.

·‘Other’ monkey species, namely 17 monkeys from Ceboidea and Cercopithecoidea species used in connection with a single experiment on their behaviour in zoo conditions.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No such cases were found. It appears that more complete information in this regard can be provided through retrospective evaluations carried out by local ethics committees.

Poland: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

89880

57.53%

Rats

28982

18.55%

Guinea-Pigs

5235

3.35%

Hamsters (Syrian)

150

0.1%

Hamsters (Chinese)

Mongolian gerbil

120

0.08%

Other Rodents

8108

5.19%

Rabbits

820

0.52%

Cats

Dogs

10

0.01%

Ferrets

Other carnivores

130

0.08%

Horses, donkeys and cross-breeds

73

0.05%

Pigs

1517

0.97%

Goats

24

0.02%

Sheep

1301

0.83%

Cattle

413

0.26%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

14

0.01%

Other species of New World Monkeys (Ceboidea)

3

0%

Apes

Other Mammals

700

0.45%

Domestic fowl

5067

3.24%

Other birds

6566

4.2%

Reptiles

314

0.2%

Rana

20

0.01%

Xenopus

Other Amphibians

456

0.29%

Zebra fish

950

0.61%

Other Fish

5381

3.44%

Cephalopods

Total

156234

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

135878

87.43%

Animals born in the EU but not at a registered breeder

18496

11.9%

Animals born in rest of Europe

361

0.23%

Animals born in rest of world

674

0.43%

Total

155409

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

17

100%

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

17

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

17

100%

Self-sustaining colony

Total

17

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

113639

72.74%

Translational and applied research

16135

10.33%

Regulatory use and Routine production

24762

15.85%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

43

0.03%

Preservation of species

25

0.02%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1129

0.72%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

501

0.32%

Total

156234

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

8173

7.19%

Cardiovascular Blood and Lymphatic System

6727

5.92%

Nervous System

52548

46.24%

Respiratory System

784

0.69%

Gastrointestinal System including Liver

3070

2.7%

Musculoskeletal System

673

0.59%

Immune System

7755

6.82%

Urogenital/Reproductive System

2929

2.58%

Sensory Organs (skin, eyes and ears)

225

0.2%

Endocrine System/Metabolism

5992

5.27%

Multisystemic

5956

5.24%

Ethology / Animal Behaviour /Animal Biology

10531

9.27%

Other basic research

8276

7.28%

Total

113639

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

3081

19.1%

Human Infectious Disorders

366

2.27%

Human Cardiovascular Disorders

815

5.05%

Human Nervous and Mental Disorders

1176

7.29%

Human Respiratory Disorders

943

5.84%

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

64

0.4%

Human Immune Disorders

120

0.74%

Human Urogenital/Reproductive Disorders

44

0.27%

Human Sensory Organ Disorders (skin, eyes and ears)

20

0.12%

Human Endocrine/Metabolism Disorders

316

1.96%

Other Human Disorders

35

0.22%

Animal Diseases and Disorders

678

4.2%

Animal Welfare

3852

23.87%

Diagnosis of diseases

3088

19.14%

Plant diseases

Non-regulatory toxicology and ecotoxicology

1537

9.53%

Total

16135

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

16493

66.61%

Other efficacy and tolerance testing

195

0.79%

Toxicity and other safety testing including pharmacology

7784

31.44%

Routine production

290

1.17%

Total

24762

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

3982

24.14%

Pyrogenicity testing

236

1.43%

Batch potency testing

11482

69.62%

Other quality controls

793

4.81%

Total

16493

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1050

13.49%

Skin irritation/corrosion

139

1.79%

Skin sensitisation

707

9.08%

Eye irritation/corrosion

9

0.12%

Repeated dose toxicity

807

10.37%

Carcinogenicity

Genotoxicity

Neurotoxicity

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Safety testing in food and feed area

Target animal safety

Reproductive toxicity

669

8.59%

Developmental toxicity

1694

21.76%

Kinetics

30

0.39%

Ecotoxicity

2364

30.37%

Other toxicity/safety testing

315

4.05%

Total

7784

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

180

17.14%

Other lethal methods

Non lethal methods

870

82.86%

Total

1050

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

387

47.96%

29 - 90 days

420

52.04%

> 90 days

Total

807

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

2364

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

2364

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

290

100%

Total

290

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

16523

66.73%

Legislation on medicinal products for veterinary use and their residues

2251

9.09%

Medical devices legislation

916

3.7%

Industrial chemicals legislation

2652

10.71%

Plant protection product legislation

2276

9.19%

Biocides legislation

24

0.1%

Food legislation including food contact material

120

0.48%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

24762

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

24221

97.82%

Legislation satisfying national requirements only [within EU]

514

2.08%

Legislation satisfying Non-EU requirements only

27

0.11%

Total

24762

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

155426

99.48%

Yes

808

0.52%

Total

156234

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

4791

3.07%

Mild [up to and including]

50260

32.17%

Moderate

50013

32.01%

Severe

51170

32.75%

Total

156234

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

155876

99.77%

Yes

358

0.23%

Total

156234

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

146889

94.02%

Genetically altered without a harmful phenotype

5905

3.78%

Genetically altered with a harmful phenotype

3440

2.2%

Total

156234

100.00%



Portugal

Portugal: Narrative 2015 – no narrative submitted

No narrative submitted by the Member State

Portugal: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

13175

63.88%

Rats

2399

11.63%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

46

0.22%

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

250

1.21%

Other Fish

4752

23.04%

Cephalopods

1

0%

Total

20623

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

16287

85.59%

Animals born in the EU but not at a registered breeder

1896

9.96%

Animals born in rest of Europe

Animals born in rest of world

847

4.45%

Total

19030

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

11853

57.47%

Translational and applied research

7288

35.34%

Regulatory use and Routine production

1382

6.7%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

3

0.01%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

97

0.47%

Total

20623

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

266

2.24%

Cardiovascular Blood and Lymphatic System

576

4.86%

Nervous System

1859

15.68%

Respiratory System

Gastrointestinal System including Liver

230

1.94%

Musculoskeletal System

330

2.78%

Immune System

5965

50.32%

Urogenital/Reproductive System

19

0.16%

Sensory Organs (skin, eyes and ears)

100

0.84%

Endocrine System/Metabolism

Multisystemic

8

0.07%

Ethology / Animal Behaviour /Animal Biology

347

2.93%

Other basic research

2153

18.16%

Total

11853

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

10

0.14%

Human Infectious Disorders

1019

13.98%

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

2002

27.47%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

88

1.21%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

350

4.8%

Human Endocrine/Metabolism Disorders

89

1.22%

Other Human Disorders

230

3.16%

Animal Diseases and Disorders

Animal Welfare

3500

48.02%

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

7288

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

1382

100%

Total

1382

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

200

14.47%

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Ecotoxicity

750

54.27%

Safety testing in food and feed area

432

31.26%

Total

1382

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

200

100%

Total

200

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

750

100%

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

750

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

750

54.27%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

632

45.73%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

1382

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

Legislation satisfying national requirements only [within EU]

1382

100%

Legislation satisfying Non-EU requirements only

Total

1382

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

19030

92.28%

Yes

1593

7.72%

Total

20623

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

213

1.03%

Mild [up to and including]

11207

54.34%

Moderate

6832

33.13%

Severe

2371

11.5%

Total

20623

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

20573

99.76%

Yes

50

0.24%

Total

20623

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

15339

74.38%

Genetically altered without a harmful phenotype

2116

10.26%

Genetically altered with a harmful phenotype

3168

15.36%

Total

20623

100.00%

Portugal: Narrative 2016 - no narrative submitted

No narrative submitted by the Member State

Portugal: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

28892

91.11%

Rats

2251

7.1%

Guinea-Pigs

4

0.01%

Hamsters (Syrian)

6

0.02%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

39

0.12%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

451

1.42%

Other Fish

69

0.22%

Cephalopods

Total

31712

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

30784

97.64%

Animals born in the EU but not at a registered breeder

623

1.98%

Animals born in rest of Europe

Animals born in rest of world

120

0.38%

Total

31527

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

14894

46.97%

Translational and applied research

9548

30.11%

Regulatory use and Routine production

185

0.58%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

37

0.12%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

102

0.32%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

6946

21.9%

Total

31712

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

680

4.57%

Cardiovascular Blood and Lymphatic System

159

1.07%

Nervous System

2982

20.02%

Respiratory System

95

0.64%

Gastrointestinal System including Liver

307

2.06%

Musculoskeletal System

240

1.61%

Immune System

7543

50.64%

Urogenital/Reproductive System

90

0.6%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

562

3.77%

Multisystemic

92

0.62%

Ethology / Animal Behaviour /Animal Biology

1074

7.21%

Other basic research

1070

7.18%

Total

14894

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

505

5.29%

Human Infectious Disorders

5782

60.56%

Human Cardiovascular Disorders

300

3.14%

Human Nervous and Mental Disorders

477

5%

Human Respiratory Disorders

82

0.86%

Human Gastrointestinal Disorders including Liver

161

1.69%

Human Musculoskeletal Disorders

72

0.75%

Human Immune Disorders

784

8.21%

Human Urogenital/Reproductive Disorders

10

0.1%

Human Sensory Organ Disorders (skin, eyes and ears)

221

2.31%

Human Endocrine/Metabolism Disorders

151

1.58%

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

99

1.04%

Diagnosis of diseases

904

9.47%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

9548

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

185

100%

Total

185

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Safety testing in food and feed area

185

100%

Total

185

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

185

100%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

185

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

185

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

185

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

31527

99.42%

Yes

185

0.58%

Total

31712

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

369

1.16%

Mild [up to and including]

14043

44.28%

Moderate

9487

29.92%

Severe

7813

24.64%

Total

31712

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

31438

99.14%

Yes

274

0.86%

Total

31712

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

19723

62.19%

Genetically altered without a harmful phenotype

9795

30.89%

Genetically altered with a harmful phenotype

2194

6.92%

Total

31712

100.00%

Portugal: Narrative 2017 - no narrative submitted

No narrative submitted by the Member State

Portugal: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

46107

88.04%

Rats

3135

5.99%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

140

0.27%

Rabbits

36

0.07%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

155

0.3%

Goats

Sheep

30

0.06%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

32

0.06%

Domestic fowl

120

0.23%

Other birds

56

0.11%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

1280

2.44%

Other Fish

829

1.58%

Cephalopods

450

0.86%

Total

52370

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

49301

96.09%

Animals born in the EU but not at a registered breeder

1678

3.27%

Animals born in rest of Europe

Animals born in rest of world

329

0.64%

Total

51308

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

36663

70.01%

Translational and applied research

5202

9.93%

Regulatory use and Routine production

298

0.57%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

392

0.75%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

9815

18.74%

Total

52370

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

3230

8.81%

Cardiovascular Blood and Lymphatic System

1205

3.29%

Nervous System

4952

13.51%

Respiratory System

83

0.23%

Gastrointestinal System including Liver

683

1.86%

Musculoskeletal System

173

0.47%

Immune System

20968

57.19%

Urogenital/Reproductive System

36

0.1%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

1437

3.92%

Multisystemic

153

0.42%

Ethology / Animal Behaviour /Animal Biology

1277

3.48%

Other basic research

2466

6.73%

Total

36663

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

162

3.11%

Human Infectious Disorders

403

7.75%

Human Cardiovascular Disorders

68

1.31%

Human Nervous and Mental Disorders

2058

39.56%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

102

1.96%

Human Musculoskeletal Disorders

127

2.44%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

233

4.48%

Human Endocrine/Metabolism Disorders

36

0.69%

Other Human Disorders

Animal Diseases and Disorders

3

0.06%

Animal Welfare

604

11.61%

Diagnosis of diseases

914

17.57%

Plant diseases

Non-regulatory toxicology and ecotoxicology

492

9.46%

Total

5202

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Other efficacy and tolerance testing

Quality control (incl batch safety and potency testing)

Routine production

Toxicity and other safety testing including pharmacology

298

100%

Total

298

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Ecotoxicity

126

42.28%

Safety testing in food and feed area

172

57.72%

Total

298

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

126

100%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

126

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

126

42.28%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

172

57.72%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

298

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

298

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

298

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

51308

97.97%

Yes

1062

2.03%

Total

52370

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

2017

3.85%

Mild [up to and including]

27397

52.31%

Moderate

12540

23.95%

Severe

10416

19.89%

Total

52370

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

51836

98.98%

Yes

534

1.02%

Total

52370

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

30557

58.35%

Genetically altered without a harmful phenotype

20466

39.08%

Genetically altered with a harmful phenotype

1347

2.57%

Total

52370

100.00%

Romania

Romania: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

Compared to the last report, the one from 2014, there was a decrease in the number of total animals used for scientific purposes, with 0,53%, from 19735 in 2014 to 19632 in 2015.

To the purpose of use has been a decrease in the use of animals for higher education or training and an increased use of animals in research.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

The difference between 2014 and 2015 is minim, given the fact that is less de 1%.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Some changes were observed in severity trend. 26% severe in 2015 vs 0.05% in 2014. 0.59% non- recovery in 2015 vs 17.31% in 2014. 39.27% mild in 2015 vs 62.344 in 2014. 34.14% moderate vs 20.30% in 2014.

The reason is that now, in this year, our colleague learned to done a severity assessment.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The competent authorities and scientific organizations in the field through briefings, workshops and trainings have imposed a positive trend of the 3Rs, and the result is decrease in the number of animals used.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The animals use under “other" categories are 0.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Such a kind of analysis was not made yet.



Romania: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

10876

55.4%

Rats

6322

32.2%

Guinea-Pigs

1108

5.64%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

380

1.94%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

2

0.01%

Pigs

10

0.05%

Goats

Sheep

167

0.85%

Cattle

2

0.01%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

565

2.88%

Other birds

Reptiles

Rana

200

1.02%

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

19632

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

18162

94.22%

Animals born in the EU but not at a registered breeder

1115

5.78%

Animals born in rest of Europe

Animals born in rest of world

Total

19277

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

7752

39.49%

Translational and applied research

3240

16.5%

Regulatory use and Routine production

7498

38.19%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1142

5.82%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

19632

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

3499

45.14%

Cardiovascular Blood and Lymphatic System

800

10.32%

Nervous System

289

3.73%

Respiratory System

200

2.58%

Gastrointestinal System including Liver

20

0.26%

Musculoskeletal System

188

2.43%

Immune System

162

2.09%

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

84

1.08%

Ethology / Animal Behaviour /Animal Biology

50

0.64%

Other basic research

2460

31.73%

Total

7752

100.00%



Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

32

0.99%

Human Infectious Disorders

20

0.62%

Human Cardiovascular Disorders

110

3.4%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

85

2.62%

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

69

2.13%

Human Endocrine/Metabolism Disorders

Other Human Disorders

30

0.93%

Animal Diseases and Disorders

102

3.15%

Animal Welfare

66

2.04%

Diagnosis of diseases

2726

84.14%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

3240

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

6184

82.48%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

927

12.36%

Routine production

387

5.16%

Total

7498

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

5456

88.23%

Pyrogenicity testing

58

0.94%

Batch potency testing

670

10.83%

Other quality controls

Total

6184

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

187

20.17%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

740

79.83%

Total

927

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

187

100%

Total

187

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

740

100%

29 - 90 days

> 90 days

Total

740

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

321

82.95%

Monoclonal antibody by mouse ascites method

Other product types

66

17.05%

Total

387

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

6404

85.41%

Legislation on medicinal products for veterinary use and their residues

731

9.75%

Medical devices legislation

363

4.84%

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

7498

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

7438

99.2%

Legislation satisfying national requirements only [within EU]

2

0.03%

Legislation satisfying Non-EU requirements only

58

0.77%

Total

7498

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

19277

98.19%

Yes

355

1.81%

Total

19632

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

88

0.45%

Mild [up to and including]

9958

50.72%

Moderate

5550

28.27%

Severe

4036

20.56%

Total

19632

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

19632

100%

Yes

Total

19632

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

19032

96.94%

Genetically altered without a harmful phenotype

600

3.06%

Genetically altered with a harmful phenotype

Total

19632

100.00%

Romania: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

Compared to the last report, the one from 2015, there was a decrease in the number of total animals used for scientific purposes (around 20.000 in 2015 and around 13.000 in 2016).

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

To the purpose of use has been a decrease in the use of animals for higher education or training and diagnosis of the disease and an increased use of animals in research.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Some changes were observed in severity trend. The main category of severity was moderate followed by mild and severe. It have been reduced non - recovery category.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The competent authorities and scientific organizations in the field through briefings, workshops and trainings have imposed a positive trend of the 3Rs, and the result is decrease in the number of animals used.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The animals use under “other" categories are not in a significant proportion.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Such a kind of analysis was not made yet.

Romania: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

9079

64.08%

Rats

2685

18.95%

Guinea-Pigs

1076

7.59%

Hamsters (Syrian)

146

1.03%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

222

1.57%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

2

0.01%

Pigs

Goats

Sheep

211

1.49%

Cattle

2

0.01%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

555

3.92%

Other birds

Reptiles

Rana

190

1.34%

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

14168

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

12592

90.95%

Animals born in the EU but not at a registered breeder

1253

9.05%

Animals born in rest of Europe

Animals born in rest of world

Total

13845

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

4011

28.31%

Translational and applied research

3183

22.47%

Regulatory use and Routine production

5402

38.13%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1572

11.1%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

14168

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

935

23.31%

Cardiovascular Blood and Lymphatic System

485

12.09%

Nervous System

190

4.74%

Respiratory System

Gastrointestinal System including Liver

261

6.51%

Musculoskeletal System

92

2.29%

Immune System

334

8.33%

Urogenital/Reproductive System

170

4.24%

Sensory Organs (skin, eyes and ears)

120

2.99%

Endocrine System/Metabolism

70

1.75%

Multisystemic

884

22.04%

Ethology / Animal Behaviour /Animal Biology

200

4.99%

Other basic research

270

6.73%

Total

4011

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

15

0.47%

Human Infectious Disorders

4

0.13%

Human Cardiovascular Disorders

86

2.7%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

277

8.7%

Animal Welfare

Diagnosis of diseases

2742

86.15%

Plant diseases

Non-regulatory toxicology and ecotoxicology

59

1.85%

Total

3183

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

4913

90.95%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

171

3.17%

Routine production

318

5.89%

Total

5402

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

4260

86.71%

Pyrogenicity testing

27

0.55%

Batch potency testing

584

11.89%

Other quality controls

42

0.85%

Total

4913

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

74

43.27%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Target animal safety

Skin sensitisation

97

56.73%

Total

171

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

74

100%

Total

74

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

303

95.28%

Monoclonal antibody by mouse ascites method

Other product types

15

4.72%

Total

318

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

3992

73.9%

Legislation on medicinal products for veterinary use and their residues

1096

20.29%

Medical devices legislation

314

5.81%

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

5402

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

5364

99.3%

Legislation satisfying national requirements only [within EU]

11

0.2%

Legislation satisfying Non-EU requirements only

27

0.5%

Total

5402

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

13845

97.72%

Yes

323

2.28%

Total

14168

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

169

1.19%

Mild [up to and including]

7693

54.3%

Moderate

5498

38.81%

Severe

808

5.7%

Total

14168

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

14168

100%

Yes

Total

14168

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

13885

98%

Genetically altered without a harmful phenotype

283

2%

Genetically altered with a harmful phenotype

Total

14168

100.00%



Romania: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

Since the previous reporting year, there was a slight increase in the number of total animals used for scientific purposes, from 14168 in 2016 to 14642 in 2017.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

There was a significant decrease in the diagnosis of diseases within the translational and applied research due to the reduced number of samples received.

There was a decrease in regulatory use and routine production, with a significant drop in blood based products and batch safety testing and an increase in batch potency testing. The latter occurred due to an increase in the vaccines production

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

There were some variations in terms of severity, namely a decrease in mild and an increase in non-recovery, according to those who evaluated the projects.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

There was a joint effort from the competent authority and the scientific organizations to promote the principle of replacement, reduction and refinement through briefings and workshops.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

No significant proportion of animal use was reported under “other" categories.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

There were not cases where “severe” classification was exceeded.

Romania: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

7975

54.47%

Rats

4367

29.83%

Guinea-Pigs

792

5.41%

Hamsters (Syrian)

150

1.02%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

504

3.44%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

2

0.01%

Pigs

58

0.4%

Goats

Sheep

209

1.43%

Cattle

2

0.01%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

330

2.25%

Other birds

23

0.16%

Reptiles

Rana

230

1.57%

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

14642

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

12356

86.54%

Animals born in the EU but not at a registered breeder

1922

13.46%

Animals born in rest of Europe

Animals born in rest of world

Total

14278

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

5381

36.75%

Translational and applied research

5500

37.56%

Regulatory use and Routine production

2522

17.22%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1239

8.46%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

14642

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

1525

28.34%

Cardiovascular Blood and Lymphatic System

539

10.02%

Nervous System

634

11.78%

Respiratory System

Gastrointestinal System including Liver

165

3.07%

Musculoskeletal System

339

6.3%

Immune System

1349

25.07%

Urogenital/Reproductive System

70

1.3%

Sensory Organs (skin, eyes and ears)

10

0.19%

Endocrine System/Metabolism

318

5.91%

Multisystemic

342

6.36%

Ethology / Animal Behaviour /Animal Biology

90

1.67%

Other basic research

Total

5381

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

114

2.07%

Human Cardiovascular Disorders

211

3.84%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

286

5.2%

Human Musculoskeletal Disorders

260

4.73%

Human Immune Disorders

275

5%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

121

2.2%

Human Endocrine/Metabolism Disorders

690

12.55%

Other Human Disorders

Animal Diseases and Disorders

74

1.35%

Animal Welfare

Diagnosis of diseases

3040

55.27%

Plant diseases

Non-regulatory toxicology and ecotoxicology

429

7.8%

Total

5500

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1789

70.94%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

106

4.2%

Routine production

627

24.86%

Total

2522

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

721

40.3%

Pyrogenicity testing

234

13.08%

Batch potency testing

753

42.09%

Other quality controls

81

4.53%

Total

1789

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

20

18.87%

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Ecotoxicity

86

81.13%

Total

106

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

20

100%

Total

20

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

86

100%

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

86

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

587

93.62%

Monoclonal antibody by mouse ascites method

Other product types

40

6.38%

Total

627

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1078

42.74%

Legislation on medicinal products for veterinary use and their residues

1253

49.68%

Medical devices legislation

170

6.74%

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

20

0.79%

Feed legislation including legislation for the safety of target animals, workers and environment

1

0.04%

Cosmetics legislation

Other legislation

Total

2522

100.00%



Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2138

84.77%

Legislation satisfying national requirements only [within EU]

2

0.08%

Legislation satisfying Non-EU requirements only

382

15.15%

Total

2522

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

14278

97.51%

Yes

364

2.49%

Total

14642

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

2110

14.41%

Mild [up to and including]

5061

34.56%

Moderate

6094

41.62%

Severe

1377

9.4%

Total

14642

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

14642

100%

Yes

Total

14642

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

14289

97.59%

Genetically altered without a harmful phenotype

353

2.41%

Genetically altered with a harmful phenotype

Total

14642

100.00%



Slovakia

Slovakia: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

New information on keeping GM (genetically modified) animal lines appeared in the Report from year 2015. In SK the new GM lines were not established, just were kept on the basis of approved Project.

In comparison to the previous year, 3213 less animals were used in the projects. It was caused also by the fact, that more of the approved establishments did not perform any projects in 2015. Some of the establishments informed in advance about the closure of their establishment, because they were not able to assure the compliance with the requirements for placing and treatment of the animals, appointed by the Directive.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Red numbers appeared in the column “other birds” of the Report, in particular in Zebra finch (Taeniopygia guttata) species, with the information on consumption of used animals of 13,95 % , which compared to the previous year, is more. It concerns one approved project for one applicant, approved for performance from15.05.2014 to 31.12.2017. Each year, the applicant consumed 36 birds on the average. It is allowed to use 80 male and 15 female animals within this approved project. By the time of duration of the project, 72 animals were already used. In comparison to the previous year, we did not record significant increase in use of the animals of this category in the project. The same number of animals were used in 2015 as in previous year 2014.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

During year 2015, any significant changes in evaluation of cruelty did not appear in the projects, comparing to the year 2014.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Observance of 3R principles is established in our legislation, it is required to observe 3R principles in performance of the projects and breeding and treating of the animals. Great attention is given to 3R principles in trainings of the assigned persons, stated in Article 23 of the Directive.

5. Further breakdown on the use of "other"categories if a significant proportion of animal use is reported under this category.

In SK any other more significant animal categories are used, just those already stated in the Report.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

In SK, there is an Act (No.: 71/67 Coll. on Administrative Order), establishing that the issued decisions are obligatory for the applicant. Any kind of arbitrary change against the project is illegal. This defect, according to the its importance, can be considered as an administrative offence and a penalty can be imposed for it. Each project is classified according to the level of severity, due to the Annex VIII of the Directive. The level of severity of the procedures is stated in the Decision for authorisation of the projects. In SK any situation of arbitrary change of the level of severity towards it increase, cannot appear. It is not possible to use in the projects a different number of animals as those approved, without permission. Within annual reports, CA would see the changes of the levels of severity and the numbers of used animals on the contrary to the Decisions for authorisation of the projects, issued by CA. There is also feed-back in performance of the controls in the approved establishments.

Slovakia: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

6046

44.66%

Rats

5841

43.15%

Guinea-Pigs

1026

7.58%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

33

0.24%

Other Rodents

Rabbits

228

1.68%

Cats

29

0.21%

Dogs

34

0.25%

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

16

0.12%

Goats

Sheep

26

0.19%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

222

1.64%

Other birds

36

0.27%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

13537

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

13537

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

13537

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

9870

72.91%

Translational and applied research

788

5.82%

Regulatory use and Routine production

2048

15.13%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

8

0.06%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

823

6.08%

Total

13537

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

796

8.06%

Cardiovascular Blood and Lymphatic System

1371

13.89%

Nervous System

2192

22.21%

Respiratory System

992

10.05%

Gastrointestinal System including Liver

194

1.97%

Musculoskeletal System

106

1.07%

Immune System

421

4.27%

Urogenital/Reproductive System

2596

26.3%

Sensory Organs (skin, eyes and ears)

40

0.41%

Endocrine System/Metabolism

496

5.03%

Multisystemic

138

1.4%

Ethology / Animal Behaviour /Animal Biology

11

0.11%

Other basic research

517

5.24%

Total

9870

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

134

17.01%

Human Infectious Disorders

Human Cardiovascular Disorders

79

10.03%

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

314

39.85%

Human Urogenital/Reproductive Disorders

80

10.15%

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

75

9.52%

Animal Diseases and Disorders

62

7.87%

Animal Welfare

Diagnosis of diseases

44

5.58%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

788

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1462

71.39%

Other efficacy and tolerance testing

6

0.29%

Toxicity and other safety testing including pharmacology

580

28.32%

Routine production

Total

2048

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1262

86.32%

Other quality controls

Pyrogenicity testing

Batch potency testing

200

13.68%

Total

1462

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

253

43.62%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Target animal safety

Skin sensitisation

35

6.03%

Repeated dose toxicity

292

50.34%

Total

580

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

253

100%

Other lethal methods

Non lethal methods

Total

253

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

90

30.82%

> 90 days

202

69.18%

Total

292

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1385

67.63%

Legislation on medicinal products for veterinary use and their residues

126

6.15%

Medical devices legislation

90

4.39%

Industrial chemicals legislation

245

11.96%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

202

9.86%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

2048

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2048

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

2048

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

13537

100%

Yes

Total

13537

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

1402

10.36%

Mild [up to and including]

8226

60.77%

Moderate

3639

26.88%

Severe

270

1.99%

Total

13537

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

13537

100%

Yes

Total

13537

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

12679

93.66%

Genetically altered without a harmful phenotype

99

0.73%

Genetically altered with a harmful phenotype

759

5.61%

Total

13537

100.00%



Slovakia: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

In 2016, in SK 5% less animals were used in the projects than in 2015. From the total number of used animals the most were used rats (46, 6%). There were 40, 9% of mice, 7,4% of guinea-pigs, 2,8% of rabbits, 2% of poultry used. As many as 96% of rodentials were used in the scientific programs. The rest was poultry. On 31 December 2016, the transition period for implementation of the requirements established in Annex III of the Directive 2010/63/EU finished.

Since 2013, in SK re-accreditation of all approved establishments of the users, breeders and suppliers, according to new legislative requirements, was carried out. In 2016, 4 (four) establishments of the users asked the Competent Authority for their withdrawal and discard from the list of approved establishments of the users, for the reason of technical and economical demandingness. 5 (five) users asked for withdrawal of the approval of their establishment for the reason of change of the legal person and the change of address in order to merge into one legal subject. In SK, general reconstruction of several establishments for placement of animals used in the procedures or kept for the reason of their use in the procedures, was carried out. Therefore, the total number of used procedures and subsequently the number of used animals has decreased. In comparison to 2015, the number of approved establishments has changed. In 2015, 54 establishments overall were approved and in 2016, only 40 establishments were approved. Therefore, only 79 projects were approved in 2016 in comparison to 2015, when SVFA SR as the competent authority has issued 102 decisions on the approval of the projects. The most common use of the animals was the basic research (71,3%), subsequently the use in regulated projects with common production (23,4%), then (3,1%) was used in keeping of GMO breeding colonies, and (2,2%) in translation/applied research. In frame of the basic research, mainly nervous system (30%), reproductive system (16%) and immunity system (14%) were declared as the common research areas. 99,67% of used animals were kept/breeded within EU. None of the animals were reused again. 93% of the used animals were without GM and 7% of all used animals were GM.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In comparison to 2015, the changes in % are as follows: the number of used mice has decreased by 13% and quinea-pigs by 7%. Increase of the number of used rats has been proved by 2% and rabbits by 59%. In 2016 comparing to the last year, domestic dogs have not been used in any of the procedures. In 2015, 34 dogs were used. The number of used cats decreased from 29 to 11 cats only. In comparison to the last year, the use of other mammals (cattle, pigs, sheep) decreased by 80%. According to withdrawal of the decisions for approval of some of the users establishments and with respect to reduction or stopping of the procedures of some of the users establishments, a significant decrease of the animals used in the procedures namely in mice and quinea-pigs occurred. Decreased number of used mice and quinea-pigs is related to the research procedures of some establishments, which ceased or suspended from their activities by the reason of reconstruction in 2016. The cause is also that minimum 5 users have merged into one legal subject and they had to abolish their establishments. Reconstructions of the establishments had been performed in the establishments using dogs and cats, therefore their number has been reduced or decreased to minimum.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In 2016, 52% of projects were classified as “non-recovery” or “,mild”, 46% of the total number were projects classified as ”moderate”, (in 2015, the “moderate” projects were represented only by 27% of all approved establishments), and projects classified as “severe” were represented by 1,2% of the total number of the approved projects. The number of severe projects decreased from 2% in 2015. The reason of increased number of the projects classified as “moderate” can be that the applicants for the approval of projects, performing projects classified as “severe” last year, have refined their procedures, therefore their projects automatically came into category “moderate”. 

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The obligation to comply with 3R principles is established by the legislation. This topics is presented in details at trainings of staff carrying functions referred to in Article 23 of the Directive. During controls of the establishments of the users, breeders and suppliers carried out in a frequency established by the law, a great attention is taken to observance of the 3R principles during performance of the projects and in animal placement and animal care. There is a great space in SK for the performance of “in-vitro” projects, using alternative methods and providing information of 3R principles, also declared in up-dating of the activities in the table due to the Article 47 of the Directive, published on web site of the Competent Authority SVFA SR.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In the category „other basic research” a significant increase of the used animals has occurred. The number of 517 animals from 2015 increased to 1875 animals in 2016, which represents almost 20% more animals used in this area. It was found out after the additional control, that some users have incorrectly assigned the objective of the project to the concerned performed type of the project. No significant increase of the number of used animals was recorded in other areas. 

In category “other birds” increased number of used animals by 12,45% in comparison to the last year was indicated. 32 pcs of Zebra finch was used in the approved project in 2016. This is not a significant increase whereas the project is approved for the period of 5 (five) years and annualy approximately 30-40 birds are used

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

In the process of authorisation of the project of the user, breeder or supplier in SK, an Authorization Decision is issued. In the Authorization Decision all necessary detailed information, including classification of severity, authorized exemptions within the frame of performance of the project or breeding or animal supplies are specified. According to the seriousness of the infringement it is possible to resolve the infringement of any type of the decision either by issuing veterinary measures in the administrative procedure, or by issuing veterinary measures on site. A penalty on site or financial penalty through administrative procedure can also be imposed. If shortcomings are not eliminated up to the stated deadline, it is possible to increase the penalty, or abolish the decision on authorization of the project or establishment.

Such a case has not happened in SK yet. All establishments are regularly controlled due to the specified frequency. In 2016, altogether 38 controls of the establishments were carried out. Included 2 controls which were follow-up – additional for the purpose of control of elimination of found shortcomings. 29 controls were carried out for the purpose of authorisation of the establishments of the users, breeders or suppliers and 7 controls for the reason of control of the compliance of requirements in the approved establishments. During retrospective assessment, an Advisory Body and the Competent Authority reviewed that each of the projects intended for the reverse control was resent and evaluated. In each “severe” project, several available possibilities for its refinement were used in order to assure that the animals would not feel cruelty/severity. In several projects submitted to the reverse assessment was found out that after their severity was classified as “moderate”. If a pain classified as “severe” occurred, all available possible measures were carried out for its refinement 

Slovakia: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

5263

41.01%

Rats

5973

46.55%

Guinea-Pigs

955

7.44%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

14

0.11%

Other Rodents

Rabbits

358

2.79%

Cats

11

0.09%

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

1

0.01%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

225

1.75%

Other birds

32

0.25%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

12832

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

12789

99.66%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

43

0.34%

Total

12832

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

8366

65.2%

Translational and applied research

1085

8.46%

Regulatory use and Routine production

2987

23.28%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

394

3.07%

Total

12832

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

146

1.75%

Cardiovascular Blood and Lymphatic System

808

9.66%

Nervous System

2746

32.82%

Respiratory System

478

5.71%

Gastrointestinal System including Liver

58

0.69%

Musculoskeletal System

52

0.62%

Immune System

1350

16.14%

Urogenital/Reproductive System

1454

17.38%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

230

2.75%

Multisystemic

23

0.27%

Ethology / Animal Behaviour /Animal Biology

40

0.48%

Other basic research

981

11.73%

Total

8366

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

40

3.69%

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

72

6.64%

Human Musculoskeletal Disorders

Human Immune Disorders

103

9.49%

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

57

5.25%

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

7

0.65%

Plant diseases

Non-regulatory toxicology and ecotoxicology

806

74.29%

Total

1085

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1533

51.32%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

1412

47.27%

Routine production

42

1.41%

Total

2987

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1298

84.67%

Other quality controls

Pyrogenicity testing

Batch potency testing

235

15.33%

Total

1533

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

388

27.48%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Target animal safety

Skin sensitisation

632

44.76%

Repeated dose toxicity

392

27.76%

Total

1412

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

388

100%

Other lethal methods

Non lethal methods

Total

388

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

392

100%

29 - 90 days

> 90 days

Total

392

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

42

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

42

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1340

44.86%

Legislation on medicinal products for veterinary use and their residues

235

7.87%

Medical devices legislation

Industrial chemicals legislation

1002

33.55%

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

410

13.73%

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

2987

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2987

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

2987

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

12832

100%

Yes

Total

12832

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

1149

8.95%

Mild [up to and including]

5588

43.55%

Moderate

5947

46.35%

Severe

148

1.15%

Total

12832

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

12832

100%

Yes

Total

12832

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

11920

92.89%

Genetically altered without a harmful phenotype

43

0.34%

Genetically altered with a harmful phenotype

869

6.77%

Total

12832

100.00%



Slovakia: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In 2017, the number of animals used in projects increased by 17,66% for the different reasons. The first reason was authorisation of two big establishments of users breeding animals for their own need, offering their establishments for performing projects also for the other users. Thereby, the space for performance of the projects in the Slovak Republic has amplified. The second reason was that by the end of year 2016, all existing establishments of users, breeders, suppliers have finished reconstructions in their establishments and therefore in 2017 they could involve in performing of the projects. In 2016, all existing establishments were newly authorised in compliance with Annex 3 of the Directive 2010/63/EU. Since 2017, scientific activities have fully developed, all authorised establishments have started to perform them. Project Agencies in SK (VEGA, APVV) have allocated financial grants for realisation of several projects authorised by the Competent Authority of SR in the area of protection of animals used for scientific purposes. Increased number of animals used in 2017 is deeply connected with this. After finishing transition period for standards of treating and housing animals until 01.01.2017, performance of the projects in establishments has developed in SK. Purpose of the projects in performance of regulated projects has increased. In comparison to year 2016, in performance of the project with the purpose non-regulatory toxicology and ecotoxicology was not reported in 2017. In the area of regulatory use and routine production a type of regulated project - reproductive toxicity occurred and a test with 29-90 days period of administration was added in the area of repeated dose toxicity. Due to the Act, in vitro methods or alternative methods are used preferentially in the regulated projects. In vivo project shall be carried out only if it is not possible to use an alternative method, if there is any. The reason is that the tested substance e.g. is not dissoluble in the dissolution reagent determined for given alternative method.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

In 2017, the number of animals used in the projects increased by 17, 66% in comparison to the year 2016. This relates also to the increase of use animals in particular areas or their decrease depending on the area of the research. Significant increase occurred in use of „other birds“, whereas in the approved project No. 2982/17-221 apart from the species Zebra finch the other species Bangalese finch has also started to be used, whereby the number of use animals increased by 7,8%. The number of animals used for maintenance GM animal colonies without their further use in the project increased by 3%. The number of used animals in basic research in the area multisystemic has increased. A project with use of 782 (7,23%) of animals for the purpose of carcinogenicity research was authorised. The project was focused on safety testing of genetically modified plants by means of toxicology methods. The number of animals used in translational and applied research has increased significantly by 50, 48%, whereas in 2016 no project with this purpose had been carried out. The number of used animals in Animal Diseases and Disorders has increased by 36 % relating to increased number of used animals in one year. In 2017, the purpose of regulated projects increased and simultaneously, the number of animals used in regulated projects decreased in general by 5%. At the same time, the number of animals used in the basic research increased by 4 % related to starting research activities of several useres establishments of the Slovak Academy of Science and Universities.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

In comparison to the year 2016, significant increase occured in classification of severity. The number of animals used in category „mild“ decreased by 10%, whereas the number of animals used in category „moderate“ increased by 11%. This is also related to the purpose of executed projects which have increased significantly in the basic research mainly in the area of „other basic research“, as stated in the table for obligatory report of the Member States. The projects in „other basic reaserch“ had been carried out for the purposes of microbiology, virology and diabetes. By using these methods also the level of severity is increasing.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The Slovak Republic annually completes and sends referred templates of the tables for reporting of support and achievements in the area of observing the principles of 3R. The tables are published at the web site of the State Veterinary and Food Administration of SR. Applicants for any kind of authorisation, whether the establishment or the project, in compliance with the Act, are obliged to describe observance of 3R principles. During controls of establishments in the area of observance of legislative requirements, inspectors of animal protection are focused mainly on the area of observance of 3R in keeping and using animals. Several users attend trainings for implementation of in vitro methods in performance of the regulated projects. In 2017, Slovakia organized an International Conference of in vitro methods EUROTOX. The subject of the observance of 3R principles is highly emphasized at the obligational training of specified functions carried out by the staff of authorised establishments of users, breeders and suppliers. Moreover, the members of Animal Welfare Body, which is established in each establishment or its services are used externally, have to supervise the compliance of these principles in the establishments.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

The number of used animals has changed significantly in basic research in the area „ other basic research“ as listed in the purpose of projects in the table for obligatory report of the Member States. The projects in „other basic research“ were carried out in the area of microbiology, virology and diabetes. Simultaneously, increase of animals category „ other birds“ from 32 in 2016 to 59 in 2017 was notified. It was caused by the use of other bird species, i.e. Bengalese finch (Lonchura striata domestica). 

6. Details on cases where the 'severe' classification is exceded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

The Competent Authority of the Slovak Republic does not register exceed of classification specified as „severe“ in 2017. In the Slovak Republic the projects classified as „severe“ are authorised. The real number of animals that have experienced pain in the projects classified as „severe“ is notified in every obligatory report sent to EU Commission. Exceed is not possible because the establishments are annually controlled by a physical control on site in the establishments by inspectors of animal protection of the District Veterinary and Food Administrations. At the same time, users are obliged to notify real severity caused to animals in the projects according to the submitted template of the tables from EU Commission. The Competent Authority of SR has got all relevant information about the projects and in case of suspicion can impose execution of a targeted control in the establishment of the respective user. Inspector of animal protection shall carry out control focused on observance of severity in the project in comparison to the Decision of authorisation of the project. In case of found incompliances, the veterinary measures or penalties are imposed.

Slovakia: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

6087

39.01%

Rats

7939

50.88%

Guinea-Pigs

1036

6.64%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

9

0.06%

Other Rodents

Rabbits

226

1.45%

Cats

11

0.07%

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

Goats

Sheep

2

0.01%

Cattle

1

0.01%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

233

1.49%

Other birds

59

0.38%

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

15603

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

15565

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

15565

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

10819

69.34%

Translational and applied research

1046

6.7%

Regulatory use and Routine production

2822

18.09%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

56

0.36%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

860

5.51%

Total

15603

100.00%



Basic Research

Basic Research

Number of uses

Percentage

Oncology

316

2.92%

Cardiovascular Blood and Lymphatic System

932

8.61%

Nervous System

4076

37.67%

Respiratory System

607

5.61%

Gastrointestinal System including Liver

180

1.66%

Musculoskeletal System

19

0.18%

Immune System

424

3.92%

Urogenital/Reproductive System

1175

10.86%

Sensory Organs (skin, eyes and ears)

9

0.08%

Endocrine System/Metabolism

610

5.64%

Multisystemic

782

7.23%

Ethology / Animal Behaviour /Animal Biology

595

5.5%

Other basic research

1094

10.11%

Total

10819

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

20

1.91%

Human Nervous and Mental Disorders

528

50.48%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

21

2.01%

Human Urogenital/Reproductive Disorders

10

0.96%

Human Sensory Organ Disorders (skin, eyes and ears)

27

2.58%

Human Endocrine/Metabolism Disorders

60

5.74%

Other Human Disorders

Animal Diseases and Disorders

374

35.76%

Animal Welfare

Diagnosis of diseases

6

0.57%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

1046

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1014

35.93%

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

1777

62.97%

Routine production

31

1.1%

Total

2822

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

867

85.5%

Other quality controls

Pyrogenicity testing

Batch potency testing

147

14.5%

Total

1014

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

653

36.75%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Safety testing in food and feed area

Skin irritation/corrosion

Target animal safety

Skin sensitisation

542

30.5%

Repeated dose toxicity

460

25.89%

Reproductive toxicity

122

6.87%

Total

1777

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

603

92.34%

Other lethal methods

Non lethal methods

50

7.66%

Total

653

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

280

60.87%

29 - 90 days

180

39.13%

> 90 days

Total

460

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

31

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

31

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1300

46.07%

Legislation on medicinal products for veterinary use and their residues

133

4.71%

Medical devices legislation

64

2.27%

Industrial chemicals legislation

946

33.52%

Plant protection product legislation

9

0.32%

Biocides legislation

Food legislation including food contact material

190

6.73%

Feed legislation including legislation for the safety of target animals, workers and environment

180

6.38%

Cosmetics legislation

Other legislation

Total

2822

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2822

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

2822

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

15565

99.76%

Yes

38

0.24%

Total

15603

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

1101

7.06%

Mild [up to and including]

5185

33.23%

Moderate

8963

57.44%

Severe

354

2.27%

Total

15603

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

15603

100%

Yes

Total

15603

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

14104

90.39%

Genetically altered without a harmful phenotype

260

1.67%

Genetically altered with a harmful phenotype

1239

7.94%

Total

15603

100.00%



Slovenia

Slovenia: Narrative 2015

1. General information on any changes in trends observed since the previous reporting period.

Number of animals used for scientific purposes in 2015 is slightly lower in comparison with numbers reported in 2014. In 2014, approximately 12.000 animals were used and in 2015, the number of animals used for scientific purposes is slightly over 9.000.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

More than 95% of all used animals in 2015 are rodents and rabbits. Mice is the most commonly used species (95%), following rats (2%) and rabbits (1, 4%). 477 animals (rodents) were reported as GA animals, 58 of them with a harmful phenotype (39 mice and 19 rats). Animals were used in basic research (endocrine system/metabolism and cardiovascular/lymphatic system).

No cats, dogs and non-human primates were used for scientific purposes in 2015.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The majority of all animals (74,17%) were used for the purpose of regulatory use and routine production. Out of this percentage, over 40% of animals (mice and rabbits) were re-used for quality control (including batch potency testing and pyrogenicity testing). The severity of each of these tests were carried out on parameters such as pain at the application and/or blood sampling, handling and equipment used in procedure and also on evaluation of the results gathered in last 10 years. It was decided that the both tests (pyrogenicity test and potency test) are classified as mild.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The principle of replacement, reduction and refinement was well considered in the use of animals in procedures for the purpose of regulatory - quality control, as prescribed and validated parameters were achieved with re-use of mice and rabbits, which in the end result in lower number of used mice and rabbits. Re-use is possible precisely because the tests are mild and non-harmful for animals. As this are standardized procedures and the testing is done only for generic products and at therapeutic dose, the procedures are classified as “mild”.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

In 2015, 57 fish (Onchorhynchus mykiss) were used in higher education or training for the acquisition, maintenance or improvement of vocational skills. Severity of procedures was classified as non-recovery or mild.

6. Details on cases where the 'severe' classification is exceded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No information submitted.

Slovenia: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

8621

95.63%

Rats

184

2.04%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

127

1.41%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

2

0.02%

Pigs

8

0.09%

Goats

Sheep

3

0.03%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

13

0.14%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

57

0.63%

Cephalopods

Total

9015

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

5400

98.58%

Animals born in the EU but not at a registered breeder

78

1.42%

Animals born in rest of Europe

Animals born in rest of world

Total

5478

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

963

10.68%

Translational and applied research

1177

13.06%

Regulatory use and Routine production

6757

74.95%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

118

1.31%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

9015

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

125

12.98%

Cardiovascular Blood and Lymphatic System

68

7.06%

Nervous System

Respiratory System

Gastrointestinal System including Liver

15

1.56%

Musculoskeletal System

35

3.63%

Immune System

174

18.07%

Urogenital/Reproductive System

74

7.68%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

472

49.01%

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

Total

963

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

1002

85.13%

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

24

2.04%

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

112

9.52%

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

39

3.31%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

1177

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

6717

99.41%

Other efficacy and tolerance testing

Routine production

Toxicity and other safety testing including pharmacology

40

0.59%

Total

6757

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

175

2.61%

Pyrogenicity testing

111

1.65%

Batch potency testing

6431

95.74%

Other quality controls

Total

6717

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Kinetics

40

100%

Total

40

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

6757

100%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

6757

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

6757

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

6757

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

5478

60.77%

Yes

3537

39.23%

Total

9015

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

105

1.16%

Mild [up to and including]

8559

94.94%

Moderate

351

3.89%

Severe

Total

9015

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

9015

100%

Yes

Total

9015

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

8538

94.71%

Genetically altered without a harmful phenotype

419

4.65%

Genetically altered with a harmful phenotype

58

0.64%

Total

9015

100.00%

Slovenia: Narrative 2016

1. General information on any changes in trends observed since the previous reporting period.

Number of animals used for scientific purposes in 2016 has dropped significantly in comparison with numbers reported in 2015. In 2015, approximately 9.000 animals were used and in 2016, the number of animals used for scientific purposes is around 6.800. The highest drop in the number of used animals was in regulatory use and routine production.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

As every year, more than 95% of all used animals are rodents and rabbits. Mice is the most commonly used species (95%), following rats (1, 36 %) and rabbits (less than 1%).

66 animals (rodents) were reported as GA animals, all without a harmful phenotype (50 mice and 16 rats). Those animals were used in basic research (oncology and cardiovascular blood and lymphatic system). No cats, dogs and non-human primates were used for scientific purposes in 2016.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Almost 86 % off all animals were used for the purpose of regulatory use and routine production. Out of this percentage, around 26 % of animals (mice and rabbits) were re-used for quality control (including batch potency testing and pyrogenicity testing). The severity of each of these tests were carried out on parameters such as pain at the application and/or blood sampling, handling and equipment used in procedure and also on evaluation of the results gathered in last 10 years. It was decided that the both tests (pyrogenicity test and potency test) are classified as mild.

1,54 % of all uses were classified as non – recovery (animals used for the purpose of translational and applied research and higher education). Almost 91% of all uses were mild, 4,5 % moderate and 3 % were classified as severe, where all uses were for the purpose of basic research (mice used for immune system research).

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The principle of replacement, reduction and refinement was well considered in the use of animals in procedures for the purpose of regulatory - quality control, as prescribed and validated parameters were achieved with re-use of mice and rabbits, which in the end result in lower number of used mice and rabbits. Re-use is possible precisely because the tests are mild and non-harmful for animals. As this are standardized procedures and the testing is done only for generic products and at therapeutic dose, the procedures are classified as “mild”.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

No information submitted.

6. Details on cases where the 'severe' classification is exceded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No information submitted.

Slovenia: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

6542

97.28%

Rats

93

1.38%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

45

0.67%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

Pigs

32

0.48%

Goats

Sheep

3

0.04%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

10

0.15%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

Cephalopods

Total

6725

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

4920

99.8%

Animals born in the EU but not at a registered breeder

10

0.2%

Animals born in rest of Europe

Animals born in rest of world

Total

4930

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

419

6.23%

Translational and applied research

1762

26.2%

Regulatory use and Routine production

4491

66.78%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

53

0.79%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

6725

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

50

11.93%

Cardiovascular Blood and Lymphatic System

16

3.82%

Nervous System

Respiratory System

Gastrointestinal System including Liver

24

5.73%

Musculoskeletal System

32

7.64%

Immune System

224

53.46%

Urogenital/Reproductive System

49

11.69%

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other basic research

24

5.73%

Total

419

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

1603

90.98%

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

17

0.96%

Human Urogenital/Reproductive Disorders

10

0.57%

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

122

6.92%

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

10

0.57%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

1762

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

4491

100%

Other efficacy and tolerance testing

Routine production

Toxicity and other safety testing including pharmacology

Total

4491

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

70

1.56%

Pyrogenicity testing

40

0.89%

Batch potency testing

4381

97.55%

Other quality controls

Total

4491

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Kinetics

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

4491

100%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

4491

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

4491

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

4491

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

4930

73.31%

Yes

1795

26.69%

Total

6725

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

16

0.24%

Mild [up to and including]

6183

91.94%

Moderate

318

4.73%

Severe

208

3.09%

Total

6725

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

6725

100%

Yes

Total

6725

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

6659

99.02%

Genetically altered without a harmful phenotype

66

0.98%

Genetically altered with a harmful phenotype

Total

6725

100.00%



Slovenia: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period.

In 2017, the number of animals used for scientific purposes has been reduced in comparison with numbers reported in previous years. The number is around 5.000 animals. The highest drop in the number of used animals was in regulatory use and routine production, where almost 50% less animals were used compared to previous years. The reason is the replacement of in vivo methods, which follows the 3R principle of replacement. Further more, the reason can be found in the termination of certain projects for certain markets, which leads in reduction of use of animals for regulatory purposes. Not negligible is also the fact, that the principle of reduction is followed as much as possible and animals are being re-used.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

As every year, more than 95% of all used animals are rodents (mice and rats) and rabbits. Mice is the most commonly used species (88%), following rats (4, 40 %) and rabbits (less than 2,63%).

There is an increase of animals used in basic research where, in comparison with previous year almost 1.000 rodents (mice in rats) were used. The number was less than 400 rodents (mice and rats) in 2016. Animals were mainly used in research for the purpose of oncology, endocrine system, immune system and gastrointestinal system including liver. The highest number of rodents was used for the research of endocrine system.

A slight increase can be observed also in the use of GA animals. While there were 66 animals reported as GA in 2016, 351 GA animals were reported in 2017. This number represent 6,70 % of all used animals in Slovenia in 2017. Out of this 351 GA animals, 288 mice were reported as GA without a harmful phenotype and 63 mice with harmful phenotype. In 2016 no GA animal with harmful phenotype was reported.

Pyrogenicity testing is still used on rabbits for the purpose of quality control including batch safety and potency testing, but only when the alternative method (in vitro method) gives doubtful results.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Majority of procedures in Slovenia are still classified as mild (over 85%), around 12% are moderate and less than 2% severe, where all uses were for basic research for the purpose of immune system research.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The principle of replacement, reduction and refinement was well considered in the use of animals in procedures for the purpose of regulatory use - quality control, as prescribed and validated parameters were achieved with the re-use of mice and rabbits, which in the end result in lower number of used mice and rabbits. Re-use is possible precisely because the tests are mild and non-harmful for animals. As this are standardized procedures and the testing is done only for generic products and at therapeutic dose, the procedures are classified as “mild”.

No cats, dogs and non-human primates were used in procedures in 2017.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

No information submitted.

6. Details on cases where the 'severe' classification is exceded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

No information submitted.

Slovenia: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

4563

88.74%

Rats

226

4.4%

Guinea-Pigs

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

135

2.63%

Cats

Dogs

Ferrets

Other carnivores

Horses, donkeys and cross-breeds

2

0.04%

Pigs

80

1.56%

Goats

Sheep

28

0.54%

Cattle

Prosimians

Marmoset and tamarins

Cynomolgus monkey

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

Domestic fowl

10

0.19%

Other birds

Reptiles

Rana

Xenopus

Other Amphibians

Zebra fish

Other Fish

98

1.91%

Cephalopods

Total

5142

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

4569

100%

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

Total

4569

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

Self-sustaining colony

Total

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1035

20.13%

Translational and applied research

1786

34.73%

Regulatory use and Routine production

2183

42.45%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

16

0.31%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

122

2.37%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

Total

5142

100.00%



Basic Research

Basic Research

Number of uses

Percentage

Oncology

149

14.4%

Cardiovascular Blood and Lymphatic System

Nervous System

70

6.76%

Respiratory System

Gastrointestinal System including Liver

150

14.49%

Musculoskeletal System

34

3.29%

Immune System

102

9.86%

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

375

36.23%

Multisystemic

59

5.7%

Ethology / Animal Behaviour /Animal Biology

48

4.64%

Other basic research

48

4.64%

Total

1035

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

1552

86.9%

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

65

3.64%

Other Human Disorders

55

3.08%

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

114

6.38%

Plant diseases

Non-regulatory toxicology and ecotoxicology

Total

1786

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

2101

96.24%

Other efficacy and tolerance testing

Routine production

Toxicity and other safety testing including pharmacology

82

3.76%

Total

2183

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

272

12.95%

Pyrogenicity testing

59

2.81%

Batch potency testing

1770

84.25%

Other quality controls

Total

2101

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Kinetics

82

100%

Total

82

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

2183

100%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

2183

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2183

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

2183

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

4569

88.86%

Yes

573

11.14%

Total

5142

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

44

0.86%

Mild [up to and including]

4372

85.03%

Moderate

637

12.39%

Severe

89

1.73%

Total

5142

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

5087

98.93%

Yes

55

1.07%

Total

5142

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

4791

93.17%

Genetically altered without a harmful phenotype

288

5.6%

Genetically altered with a harmful phenotype

63

1.23%

Total

5142

100.00%



Spain

Spain: Narrative 2015

1.General information on any changes in trends observed since the previous reporting period.

The Ministry of Agriculture, Fisheries, Food and the Environment (MAGRAMA) designed an IT application which was used for the first time this past year. Its purpose is to facilitate the collection, control and transmission of data from user centres that use animals to the European Commission’s IT application. The information is provided by the authorised centres, which input the reports from each centre in the system. The authorised centres are overseen by the competent authorities of the various Autonomous Communities which report to MAGRAMA. The latter sends the communications to the European Commission.

Both the information to be collected and the system for collecting represented significant changes. It was therefore necessary to adapt both the tools used and the organisation and assignment of the various uses to the various categories used for organising the information. This affects how the information about uses in 2014 compare with the same information in 2015. This problem should be resolved with the experience gained as future reports are created. This means that comparisons between years will be more reliable, and it will be possible to evaluate the trends which, for the moment, cannot be evaluated.

In 2015, there was a significant effort to improve the classification of uses under the corresponding headings and, as far as possible, to avoid using ‘others’.

In addition, analysis of the data showed that the severity classification ‘non-recovery’ had at times been interpreted incorrectly. For this reason, there is a change in the proportions of the various severity classifications, which is largely due to better understanding of the meaning of each category. It is also partly due to the generally accepted practice of applying the precautionary principle. As a result, where there is uncertainty between two levels of severity, the higher level of actual severity is assigned to a use.

2.Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

In the report on uses in 2015, there were uses of new species not used in 2014. Nevertheless, this is not considered highly significant as such uses are associated with projects that use such species on an occasional basis (for example, frogs).

The proportion of ‘other animal species’ is high as there are several registered users that work with wildlife.

In 2015, several lines of research associated with zootechnics were developed. This can be seen in the use of ‘production animals’, although it is partially obscured by the reduction in the use of sheep.

In addition, a new user conducting research in the field of animal nutrition has been using relatively large groups of animals. This is because the user is working in commercial conditions, which significantly increases the figures reported.

The field of aquaculture, and the development of technologies to extend the practice, requires the use of ‘non-habitual’ species of fish, such as cephalopods, in significant numbers. The main species used are sea-bream, sea-bass, turbot and trout. The notable increase in the use of cephalopods has the same [...].

The increase in genetically altered mice is notable: this is a global trend on account of the wide range of options offered by the use of such animals.

Finally, with regard to the purposes for which animals are used, there is a notable decrease in uses in basic research in parallel with the increase in applied research. A reduction is apparent in the use of animals for regulatory purposes. This is partly due to better classification of the purposes for which animals are used. The significant increase in maintaining genetically altered lines is due to the increase in altered lines and, largely, to the fact that genotyping by invasive methods was considered a procedure. The emphasis placed on the need for thorough education and training in new surgical techniques was reflected in the increase in animals intended for training and teaching.

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

In Spain, assignment of severity to the procedures is one of the most significant new features of the Directive. It was done for the first time following the application of the Directive.

Furthermore, assignment of severity is a complex process. On the one hand, it is necessary to be aware of a broad range of circumstances, and on the other hand those responsible for assigning severity need to be widely experienced. In these circumstances, and given the, as yet, brief existence of the requirement, a process of adaptation is under way. For example, some guidelines are needed to clarify certain questions that decide the final severity classification of a specific procedure.

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

It is understood that promoting the principles of the three ‘Rs’ must be done in a combined form by the users, through the various bodies responsible for animal welfare - which, in Spain, in the user centres, are known as ‘ethics committees for animal experimentation’ - [and] by the assessment bodies, which in Spain are termed ‘empowered bodies’ authorised by the competent authorities for this purpose, along with the competent authorities themselves. Given the uniqueness of the composition of the empowered bodies, the competent authorities consider it vital to concentrate on optimising that composition.

Several competent authorities have created consultative committees that conduct a supplementary assessment of ‘sensitive’ projects, especially those involving severe procedures. The purpose is a more thorough assessment of the possibilities of reducing the number of animals, and of refining the techniques in order to minimise the number of animals that come under this classification.

The points on which the greatest effort is being made are: disseminating reference tools and databases; establishing sample size correctly; encouraging pilot studies; and establishing end-point criteria with both quantitative and qualitative indicators.

One of the areas in which the greatest effort was apparent was in teaching with the increasing use of virtual simulators, artificial models, work with organs of animals not bred especially for this purpose, cadavers etc., and finally with animals for which the severity of the procedures must not exceed the classification of ‘mild’. However, this situation is not apparent in the statistics because of the increase in the number of projects authorised and conducted for the purposes of higher education or training for the acquisition, maintenance or improvement of professional skills.

5.Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

In the category ‘other animals’, the majority corresponds to ‘other fishes’, for two main reasons. The first is that the range of options for this group is limited to two options. This means that ‘other fishes’ in reality represents ‘fishes other than zebrafish’. Secondly, in Spain there are several centres dedicated to researching the biology and needs of fish in aquaculture, for example trout, sea-bream, sea-bass, turbot etc. These represent a significant number of animals.

Furthermore, there are centres that work with wildlife, also for the purpose of thoroughly understanding their biology and behaviour.

6.Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

This situation has not arisen in Spain.

Spain: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

483689

57.65%

Rats

57616

6.87%

Guinea-Pigs

7760

0.92%

Hamsters (Syrian)

665

0.08%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

193

0.02%

Rabbits

30408

3.62%

Cats

361

0.04%

Dogs

860

0.1%

Ferrets

94

0.01%

Other carnivores

Horses, donkeys and cross-breeds

210

0.03%

Pigs

9262

1.1%

Goats

389

0.05%

Sheep

1980

0.24%

Cattle

519

0.06%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

289

0.03%

Rhesus monkey

4

0%

Vervets (Chlorocebus spp.)

Baboons

18

0%

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

607

0.07%

Domestic fowl

98444

11.73%

Other birds

4585

0.55%

Reptiles

302

0.04%

Rana

14

0%

Xenopus

1304

0.16%

Other Amphibians

2267

0.27%

Zebra fish

44543

5.31%

Other Fish

76709

9.14%

Cephalopods

15848

1.89%

Total

838940

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

744953

90.26%

Animals born in the EU but not at a registered breeder

76558

9.28%

Animals born in rest of Europe

Animals born in rest of world

3802

0.46%

Total

825313

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

21

8.61%

Animals born in rest of Europe

Animals born in Asia

78

31.97%

Animals born in America

Animals born in Africa

145

59.43%

Animals born elsewhere

Total

244

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

9

3.69%

F2 or greater

185

75.82%

Self-sustaining colony

50

20.49%

Total

244

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

433171

51.63%

Translational and applied research

217468

25.92%

Regulatory use and Routine production

133876

15.96%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

17306

2.06%

Preservation of species

13

0%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

13922

1.66%

Forensic enquiries

1

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

23183

2.76%

Total

838940

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

46399

10.71%

Cardiovascular Blood and Lymphatic System

35069

8.1%

Nervous System

83966

19.38%

Respiratory System

2755

0.64%

Gastrointestinal System including Liver

49205

11.36%

Musculoskeletal System

13259

3.06%

Immune System

24368

5.63%

Urogenital/Reproductive System

6680

1.54%

Sensory Organs (skin, eyes and ears)

7809

1.8%

Endocrine System/Metabolism

29287

6.76%

Multisystemic

41201

9.51%

Ethology / Animal Behaviour /Animal Biology

18301

4.22%

Other basic research

74872

17.28%

Total

433171

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

62970

28.96%

Human Infectious Disorders

22693

10.44%

Human Cardiovascular Disorders

5317

2.44%

Human Nervous and Mental Disorders

17719

8.15%

Human Respiratory Disorders

5243

2.41%

Human Gastrointestinal Disorders including Liver

2286

1.05%

Human Musculoskeletal Disorders

3072

1.41%

Human Immune Disorders

3342

1.54%

Human Urogenital/Reproductive Disorders

1563

0.72%

Human Sensory Organ Disorders (skin, eyes and ears)

13873

6.38%

Human Endocrine/Metabolism Disorders

16953

7.8%

Other Human Disorders

1048

0.48%

Animal Diseases and Disorders

35315

16.24%

Animal Welfare

18539

8.52%

Diagnosis of diseases

5540

2.55%

Plant diseases

14

0.01%

Non-regulatory toxicology and ecotoxicology

1981

0.91%

Total

217468

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

71438

53.36%

Other efficacy and tolerance testing

288

0.22%

Toxicity and other safety testing including pharmacology

59672

44.57%

Routine production

2478

1.85%

Total

133876

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

16585

23.22%

Pyrogenicity testing

9960

13.94%

Batch potency testing

41617

58.26%

Other quality controls

3276

4.59%

Total

71438

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

16447

27.56%

Skin irritation/corrosion

103

0.17%

Skin sensitisation

630

1.06%

Eye irritation/corrosion

39

0.07%

Repeated dose toxicity

5172

8.67%

Carcinogenicity

Phototoxicity

Reproductive toxicity

Genotoxicity

60

0.1%

Developmental toxicity

90

0.15%

Neurotoxicity

8400

14.08%

Kinetics

2069

3.47%

Pharmaco-dynamics (incl safety pharmacology)

3849

6.45%

Ecotoxicity

133

0.22%

Safety testing in food and feed area

19301

32.35%

Target animal safety

3331

5.58%

Other toxicity/safety testing

48

0.08%

Total

59672

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

14047

85.41%

Other lethal methods

75

0.46%

Non lethal methods

2325

14.14%

Total

16447

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

3244

62.72%

29 - 90 days

1129

21.83%

> 90 days

799

15.45%

Total

5172

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

57

42.86%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

76

57.14%

Other ecotoxicity

Total

133

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

1759

70.98%

Monoclonal antibody by mouse ascites method

719

29.02%

Other product types

Total

2478

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

33313

24.88%

Legislation on medicinal products for veterinary use and their residues

65403

48.85%

Medical devices legislation

501

0.37%

Industrial chemicals legislation

510

0.38%

Plant protection product legislation

10

0.01%

Biocides legislation

Food legislation including food contact material

21626

16.15%

Feed legislation including legislation for the safety of target animals, workers and environment

2368

1.77%

Cosmetics legislation

Other legislation

10145

7.58%

Total

133876

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

112896

84.33%

Legislation satisfying national requirements only [within EU]

3371

2.52%

Legislation satisfying Non-EU requirements only

17609

13.15%

Total

133876

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

825557

98.4%

Yes

13383

1.6%

Total

838940

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

72630

8.66%

Mild [up to and including]

382421

45.58%

Moderate

325697

38.82%

Severe

58192

6.94%

Total

838940

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

814686

97.11%

Yes

24254

2.89%

Total

838940

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

573795

68.4%

Genetically altered without a harmful phenotype

234380

27.94%

Genetically altered with a harmful phenotype

30765

3.67%

Total

838940

100.00%



Spain: Narrative 2016

1.General information on any changes in trends observed since the previous reporting period.

The Ministry of Agriculture and Fisheries, Food and the Environment (MAPAMA) designed an IT application which, since 2014, has made it possible to facilitate the collection, control and transmission of data from user centres that use animals to the European Commission’s IT application. The user centres input their reports in the system. They are overseen by the respective competent authorities of the various Autonomous Communities which report to MAPAMA. The latter sends the communications to the European Commission.

Both the information to be collected and the system for collecting represented significant changes. There has therefore been a process of adapting both the tools used and the organisation and assignment of the various uses to the various categories used for organising the information. This meant that one action could be classified differently throughout the reporting periods.

This can affect data patterns. We therefore believe that it is too early to draw conclusions regarding trends.

In 2016, efforts were maintained to improve the classification of uses under the corresponding headings, with the identification and correction of errors in the assignment of uses to the various categories available in the data collection form and, as far as possible, avoidance of using the heading ‘others’.

In assessing the figures on uses, it must be taken into account that projects in the field of animal nutrition are undertaken in commercial production conditions. For this reason, relatively large groups of animals are used, which significantly increases the figures.

2.Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

The report on uses in 2016 includes species which are new, while others that appeared in previous reports have disappeared. Nevertheless, it is understood that these variations are not significant as they are associated with the implementation or completion of projects that use such species on an occasional basis.

The trend in increased use of genetically modified mice continues as the ability to design them to order makes them ideal experimental models for a multitude of studies.

The number of uses of fish continues to increase. This is due in part to the adaptation of the models that use zebrafish, which are being developed in an increasing number of fields, and in part to research concerning fish in aquaculture in Spain.

The proportion of ‘other animal species’ is high as there are several registered users that work with wildlife. Furthermore, as stated in the previous paragraph, the field of aquaculture, and the development of technologies to extend the practice, requires the use of ‘non-habitual’ species of fish, such as cephalopods, in significant numbers. The main species used are sole, sea-bream, sea-bass, turbot and trout.

The increase in ‘maintaining genetically modified lines’ continues. This is due both to the greater presence of the genetically modified lines themselves, and to the fact that, as of this report, genotyping by invasive methods was considered a procedure.

The need for thorough education and training in new surgical techniques was reflected in an increase in animals intended for training and teaching, making it possible to refine post-research activity.

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

As stated in previous reports, in Spain assigning severity to uses of animals is one of the most significant new aspects of Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes. It was done for the first time when the Directive was applied: in the year 2013 with the report issued in 2014.

Furthermore, assignment of severity is a complex process. On the one hand, it is necessary to be aware of a broad range of circumstances, and on the other hand those responsible for assigning severity need to be widely experienced in recognising the elements and their weighting in order to assign specific categories of severity. It is understood that, where there is uncertainty about an assignment, preference is given to assessments that are more sensitive to the suffering of the animals involved. This means that assignment tends towards the levels that are more [...]

In these circumstances, and given the, as yet, brief existence of the requirement, a process of adaptation is under way. For example, some guidelines are needed to clarify certain questions that decide the final severity classification of a specific use.

The apparent fall in the proportion of ‘non-recovery’ uses continues. However this variation can be attributed to correct information as a result of the concept of ‘non-recovery use’ being clarified rather than to any real variation in the type of procedures carried out.

Uses classified as severe, while increasing in absolute figures, remain unchanged (8% of uses) in comparison with last year when their relative importance is compared with the total uses.

The greatest severities can be seen to be associated with uses required by European Union legislation, in the category ‘regulatory use’, and to a lesser extent in studies on animal diseases.

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

It is understood that promoting the principles of the three ‘Rs’ must be done in a combined form by the competent authorities, the users, through the various bodies responsible for animal welfare - which, in Spain, in the user centres, are known as ‘ethics committees for animal experimentation’ - and by the assessment bodies, which in Spain are termed ‘empowered bodies’ authorised by the competent authorities for this purpose. Given the uniqueness of the composition of the empowered bodies, the competent authorities consider it vital to concentrate on optimising that composition.

Several competent authorities have created consultative committees that conduct a supplementary assessment of ‘sensitive’ projects, especially those involving severe procedures. The purpose is a more thorough assessment of the possibilities of reducing the number of animals, and of refining the techniques in order to minimise the number of animals that come under this classification.

Bearing in mind that the staff who work with the animals are one of the key aspects, more thorough and up-to-date training results not only in knowledge of more tools but also in greater motivation to use them.

The points on which the greatest effort is being made are: dissemination of reference tools and databases; establishing sample size correctly; encouraging pilot studies; and establishing end-point criteria with both quantitative and qualitative indicators.

One of the areas in which the greatest effort was apparent was in teaching with the increasing use of virtual simulators, artificial models, work with organs of animals not bred especially for this purpose, and cadavers.

Improvements in training and in the instruments available enable progress in refining procedures.

However, this situation is obscured in the overall statistical figures by the significant increase of those... [text unclear] not apparent in the statistics because of the increased number of projects authorised and conducted for the purposes of higher education or training for the acquisition, maintenance or improvement of professional skills.      

5.Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

In the ‘other animals’ section, a significant number of uses refer to ‘other birds’. These are limited to centres working to gain detailed knowledge of the biology and behaviour of wildlife. Almost all of these uses (96%) have been classified as ‘mild’.

However, the vast majority (95% of uses under ‘other species’) corresponds to fish other than zebrafish. In this case, it mainly concerns uses of fish species from aquaculture in order to understand their needs. Such fish include sole, trout, sea-bream, sea-bass and turbot.

A significant effort was made to avoid the classification of ‘others’ for the purposes of the uses of animals. As a result, the number fell dramatically.

6.Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

This situation has not arisen.

Spain: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

539959

61%

Rats

54910

6.2%

Guinea-Pigs

7223

0.82%

Hamsters (Syrian)

734

0.08%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

322

0.04%

Rabbits

28035

3.17%

Cats

358

0.04%

Dogs

1083

0.12%

Ferrets

74

0.01%

Other carnivores

Horses, donkeys and cross-breeds

91

0.01%

Pigs

9434

1.07%

Goats

269

0.03%

Sheep

2695

0.3%

Cattle

888

0.1%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

272

0.03%

Rhesus monkey

2

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

383

0.04%

Domestic fowl

89795

10.14%

Other birds

2400

0.27%

Reptiles

684

0.08%

Rana

30

0%

Xenopus

1091

0.12%

Other Amphibians

110

0.01%

Zebra fish

68562

7.75%

Other Fish

67324

7.61%

Cephalopods

8444

0.95%

Total

885172

100.00%



Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

840339

95.88%

Animals born in the EU but not at a registered breeder

34299

3.91%

Animals born in rest of Europe

Animals born in rest of world

1804

0.21%

Total

876442

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

115

66.47%

Animals born in America

Animals born in Africa

58

33.53%

Animals born elsewhere

Total

173

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

1

0.58%

F2 or greater

172

99.42%

Self-sustaining colony

Total

173

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

442337

49.97%

Translational and applied research

256090

28.93%

Regulatory use and Routine production

132505

14.97%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

8115

0.92%

Preservation of species

137

0.02%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

12261

1.39%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

33727

3.81%

Total

885172

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

50747

11.47%

Cardiovascular Blood and Lymphatic System

52032

11.76%

Nervous System

82046

18.55%

Respiratory System

2184

0.49%

Gastrointestinal System including Liver

10033

2.27%

Musculoskeletal System

11870

2.68%

Immune System

28232

6.38%

Urogenital/Reproductive System

11156

2.52%

Sensory Organs (skin, eyes and ears)

9328

2.11%

Endocrine System/Metabolism

16138

3.65%

Multisystemic

86591

19.58%

Ethology / Animal Behaviour /Animal Biology

77993

17.63%

Other basic research

3987

0.9%

Total

442337

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

98730

38.55%

Human Infectious Disorders

14506

5.66%

Human Cardiovascular Disorders

4516

1.76%

Human Nervous and Mental Disorders

23096

9.02%

Human Respiratory Disorders

3141

1.23%

Human Gastrointestinal Disorders including Liver

5094

1.99%

Human Musculoskeletal Disorders

3317

1.3%

Human Immune Disorders

4513

1.76%

Human Urogenital/Reproductive Disorders

3142

1.23%

Human Sensory Organ Disorders (skin, eyes and ears)

16927

6.61%

Human Endocrine/Metabolism Disorders

19038

7.43%

Other Human Disorders

Animal Diseases and Disorders

39324

15.36%

Animal Welfare

11045

4.31%

Diagnosis of diseases

8568

3.35%

Plant diseases

10

0%

Non-regulatory toxicology and ecotoxicology

1123

0.44%

Total

256090

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

74344

56.11%

Other efficacy and tolerance testing

7999

6.04%

Toxicity and other safety testing including pharmacology

49667

37.48%

Routine production

495

0.37%

Total

132505

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

20368

27.4%

Pyrogenicity testing

9878

13.29%

Batch potency testing

39956

53.74%

Other quality controls

4142

5.57%

Total

74344

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

12920

26.01%

Skin irritation/corrosion

99

0.2%

Skin sensitisation

794

1.6%

Eye irritation/corrosion

39

0.08%

Repeated dose toxicity

2032

4.09%

Carcinogenicity

146

0.29%

Genotoxicity

50

0.1%

Reproductive toxicity

530

1.07%

Developmental toxicity

166

0.33%

Neurotoxicity

2406

4.84%

Kinetics

2739

5.51%

Pharmaco-dynamics (incl safety pharmacology)

3679

7.41%

Phototoxicity

Ecotoxicity

104

0.21%

Safety testing in food and feed area

18437

37.12%

Target animal safety

5523

11.12%

Other toxicity/safety testing

3

0.01%

Total

49667

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

10946

84.72%

Other lethal methods

56

0.43%

Non lethal methods

1918

14.85%

Total

12920

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

791

38.93%

29 - 90 days

437

21.51%

> 90 days

804

39.57%

Total

2032

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

104

100%

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

104

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

140

28.28%

Monoclonal antibody by mouse ascites method

309

62.42%

Other product types

46

9.29%

Total

495

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

35421

26.73%

Legislation on medicinal products for veterinary use and their residues

67169

50.69%

Medical devices legislation

376

0.28%

Industrial chemicals legislation

3374

2.55%

Plant protection product legislation

1172

0.88%

Biocides legislation

264

0.2%

Food legislation including food contact material

20105

15.17%

Feed legislation including legislation for the safety of target animals, workers and environment

4599

3.47%

Cosmetics legislation

Other legislation

25

0.02%

Total

132505

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

111915

84.46%

Legislation satisfying national requirements only [within EU]

4092

3.09%

Legislation satisfying Non-EU requirements only

16498

12.45%

Total

132505

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

876615

99.03%

Yes

8557

0.97%

Total

885172

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

50237

5.68%

Mild [up to and including]

471092

53.22%

Moderate

300645

33.96%

Severe

63198

7.14%

Total

885172

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

855372

96.63%

Yes

29800

3.37%

Total

885172

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

520719

58.83%

Genetically altered without a harmful phenotype

319969

36.15%

Genetically altered with a harmful phenotype

44484

5.03%

Total

885172

100.00%

Spain: Narrative 2017

1.General information on any changes in trends observed since the previous reporting period.

The Ministry of Agriculture and Fisheries, Food and the Environment (MAPAMA) designed an IT application which, since 2014, has made it possible to facilitate the collection, control and transmission of data from user centres that use animals to the European Commission’s IT application. The user centres input their reports in the system. They are overseen by the respective competent authorities of the various Autonomous Communities which report to MAPAMA. The latter sends the communications to the European Commission.

Both the information to be collected and the system for collecting represented significant changes. There has therefore been a process of adapting both the tools used and the organisation and assignment of the various uses to the various categories used for organising the information. This meant that one action could be classified differently in the reports from different periods.

This can affect data patterns and make it difficult to interpret possible trends in animal use.

In assessing the figures on uses, it must be taken into account that projects in the field of animal nutrition are undertaken in commercial production conditions. For this reason, relatively large groups of animals are used, which significantly increases the figures for uses of animals.

2.Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

In 2017, the number of uses of animals for scientific purposes fell among all species except rats, carnivores, goats and cattle, reptiles and ‘other amphibians’.

In the case of rats, the greatest increase was in the area of applied research in relation to research on the gastro-intestinal system, the nervous system and the sensory organs.

Use of carnivores increased by around 45% in comparison with 2016, especially in diagnosis of diseases but also in regulatory use (mainly in kinetics and efficiency controls).

There was an increase in the use of species of farm animals for studies on diseases in such animals as target species for such diseases.

As in previous years, reptiles are mainly used in biology and ethology studies.

The common badger was used for the first time, in a study of animal diseases, as was the common spadefoot toad in studies of animal biology.

In assessing the figures on uses, it must be taken into account that there are users conducting research in the field of animal nutrition. They use relatively large groups of animals because they are working in conditions similar to commercial conditions. This significantly increases the figures reported, as can be seen in the studies carried out in the area of nutrition in chickens for fattening. This is also the reason for the significant reduction in the use of cephalopods given that, in 2017, this type of study was no longer being conducted.

The overall use of mice fell significantly, however their use increased in applied research in cancer, respiratory diseases and diseases of the nervous system.

The number of uses of fish fell by almost 40%. Nevertheless, there was a significant increase in the number of uses of genetically modified fish with a harmful phenotype, also partly due to a better understanding of the behaviour and biology of the fish, making it possible to identify the signs of the aforementioned harmful phenotype.

The proportion of ‘other animal species’ remains high as there are several registered users that work with wildlife, in particular mammals and birds. Furthermore, the field of aquaculture, and the development of technologies to extend the practice, requires the use of ‘non-habitual’ species of fish in significant numbers. The main species used are sea-bream, sea-bass, turbot, salmon and trout.

In 2017, an increase was apparent in the reuse of animals although it is difficult to evaluate the actual trend as the concept of ‘reuse’ has not always been interpreted consistently by reporters. The increase is especially clear in the reuse of dogs, cats and primates.

3.Information on any changes in trends in actual severities and analysis of the reasons thereof.

As stated in previous reports, in Spain assigning severity to uses of animals is one of the most significant new aspects of Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes. It was done for the first time when the Directive was applied: in the year 2013 with the report issued in 2014.

Furthermore, assignment of severity is a complex process. On the one hand, it is necessary to be aware of a broad range of circumstances, and on the other hand those responsible for assigning severity need to be widely experienced in recognising the elements and their weighting in order to assign specific categories of severity. It is understood that, where there is uncertainty about an assignment, preference is given to assessments that are more sensitive to the suffering of the animals involved. This means that assignment tends towards the levels that are more [...]

In 2017, as in previous years, the apparent fall in the proportion of ‘non-recovery’ uses continues. However this variation can be attributed to an improvement in the quality of the information as a result of the concept of ‘non-recovery’ use being clarified rather than to changes in the characteristics of the studies.

In 2017, an increase is apparent in the severity observed, especially in the procedures carried out with fish. This is due not only to the characteristics of the projects, but also to more training in identifying welfare indicators in this group of animals.

Nevertheless, the relative increase continues in uses with ‘mild’ severity with a corresponding decrease in ‘moderate’. This is presumably due to the application of measures to refine procedures.

As in previous years, the greatest severities are associated with regulatory uses of animals required by European Union legislation. To a lesser extent, to studies on animal diseases [...]

4.Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

It is understood that promoting the principles of the three ‘Rs’ must be done in a combined form by the competent authorities, the users, through the various bodies responsible for animal welfare - which, in Spain, in the user centres, are known as ‘ethics committees for animal experimentation’ - and by the assessment bodies, which in Spain are termed ‘empowered bodies’ authorised by the competent authorities for this purpose. Given the uniqueness of the composition of the empowered bodies, the competent authorities consider it vital to concentrate on optimising that composition.

The consultative committees established by some competent authorities conduct a supplementary assessment of ‘sensitive’ projects, especially those involving severe procedures. The purpose is a more thorough assessment of the possibilities of reducing the number of animals, and of refining the techniques in order to minimise the number of animals that undergo this level of suffering.

Staff training involves both initial skills training in order to be able to work with animals and ongoing training. It is a basic tool for correctly applying the alternative strategies to the use of live animals in research and teaching. Proper training confers not only knowledge of the techniques, approaches and tools that can be useful, but also greater motivation for using them.

The user centres are working to optimise the sharing of animal models, and of the animals themselves, especially their cadavers in order to avoid the unnecessary killing of animals.

In order to reduce the number of animals and adapt the project designs, pilot studies are being carried out to enable research to be directed to much more specific procedures.

One of the areas in which the greatest effort is being made is in dissemination of reference tools and databases, along with access to articles, publications and guides related to the application of the three ‘Rs’, using emails to centres and sector organisations.

As in previous years, efforts continue in the field of teaching with increasing use of virtual simulators, artificial models, work with organs of animals not bred especially for this purpose, and cadavers.

The inclusion of statistical experts in the teams represents an improvement in the design of procedures, making it possible to reduce the number of animals used.

Furthermore in their applications for project authorisation, project managers are required to provide increasingly detailed information with regard to strategies for applying the three ‘Rs’.

In tissue sampling, this involves improving or substituting certain techniques, for example avoiding genotyping by tail-docking.   

5.Further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category.

As in previous years, the number of uses of ‘other species’ is very high, totalling almost 50,000 uses.

The vast majority (90% of uses under ‘other species’) corresponds to fish other than zebrafish. As in previous years, it mainly concerns uses of fish species from aquaculture in order to understand their needs. Such fish include sea-bream, sea-bass, turbot, salmon and trout.

Of these ‘other animals’, 5% are birds used in the study of biology, behaviour and pathologies in wild birds.

In the case of ‘other purposes’, in basic research the majority are concerned with the field of animal nutrition, and of aquaculture, and in toxicology other quality controls, especially in conducting checks for absence of external viruses, duration of immunity and categorisation of active principles.

6.Details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‘severe’ classification was exceeded.

This situation has not arisen in Spain.

Spain: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

523467

65.19%

Rats

56036

6.98%

Guinea-Pigs

6747

0.84%

Hamsters (Syrian)

599

0.07%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

141

0.02%

Rabbits

25931

3.23%

Cats

531

0.07%

Dogs

1476

0.18%

Ferrets

164

0.02%

Other carnivores

25

0%

Horses, donkeys and cross-breeds

61

0.01%

Pigs

8656

1.08%

Goats

369

0.05%

Sheep

1953

0.24%

Cattle

1700

0.21%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

451

0.06%

Rhesus monkey

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

99

0.01%

Domestic fowl

82107

10.23%

Other birds

2535

0.32%

Reptiles

1003

0.12%

Rana

18

0%

Xenopus

1204

0.15%

Other Amphibians

1996

0.25%

Zebra fish

41020

5.11%

Other Fish

44667

5.56%

Cephalopods

20

0%

Total

802976

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

745928

94.13%

Animals born in the EU but not at a registered breeder

45911

5.79%

Animals born in rest of Europe

33

0%

Animals born in rest of world

606

0.08%

Total

792478

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

104

42.28%

Animals born in America

Animals born in Africa

142

57.72%

Animals born elsewhere

Total

246

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

2

0.81%

F2 or greater

244

99.19%

Self-sustaining colony

Total

246

100.00%



Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

329508

41.04%

Translational and applied research

281870

35.1%

Regulatory use and Routine production

120192

14.97%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

6048

0.75%

Preservation of species

371

0.05%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

11785

1.47%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

53202

6.63%

Total

802976

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

28417

8.62%

Cardiovascular Blood and Lymphatic System

26264

7.97%

Nervous System

78970

23.97%

Respiratory System

2457

0.75%

Gastrointestinal System including Liver

8885

2.7%

Musculoskeletal System

6997

2.12%

Immune System

24659

7.48%

Urogenital/Reproductive System

6548

1.99%

Sensory Organs (skin, eyes and ears)

10283

3.12%

Endocrine System/Metabolism

22634

6.87%

Multisystemic

37812

11.48%

Ethology / Animal Behaviour /Animal Biology

73215

22.22%

Other basic research

2367

0.72%

Total

329508

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

116597

41.37%

Human Infectious Disorders

13579

4.82%

Human Cardiovascular Disorders

6440

2.28%

Human Nervous and Mental Disorders

21394

7.59%

Human Respiratory Disorders

2713

0.96%

Human Gastrointestinal Disorders including Liver

8755

3.11%

Human Musculoskeletal Disorders

2052

0.73%

Human Immune Disorders

5093

1.81%

Human Urogenital/Reproductive Disorders

1160

0.41%

Human Sensory Organ Disorders (skin, eyes and ears)

15801

5.61%

Human Endocrine/Metabolism Disorders

15652

5.55%

Other Human Disorders

1651

0.59%

Animal Diseases and Disorders

50632

17.96%

Animal Welfare

8413

2.98%

Diagnosis of diseases

9848

3.49%

Plant diseases

10

0%

Non-regulatory toxicology and ecotoxicology

2080

0.74%

Total

281870

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

68653

57.12%

Other efficacy and tolerance testing

2121

1.76%

Toxicity and other safety testing including pharmacology

48164

40.07%

Routine production

1254

1.04%

Total

120192

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

23330

33.98%

Pyrogenicity testing

9472

13.8%

Batch potency testing

31416

45.76%

Other quality controls

4435

6.46%

Total

68653

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

11069

22.98%

Skin irritation/corrosion

43

0.09%

Skin sensitisation

616

1.28%

Eye irritation/corrosion

11

0.02%

Repeated dose toxicity

6225

12.92%

Carcinogenicity

56

0.12%

Genotoxicity

22

0.05%

Phototoxicity

Reproductive toxicity

Developmental toxicity

759

1.58%

Neurotoxicity

2017

4.19%

Kinetics

3364

6.98%

Pharmaco-dynamics (incl safety pharmacology)

1476

3.06%

Ecotoxicity

156

0.32%

Safety testing in food and feed area

21778

45.22%

Target animal safety

486

1.01%

Other toxicity/safety testing

86

0.18%

Total

48164

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

10180

91.97%

Other lethal methods

Non lethal methods

889

8.03%

Total

11069

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

1906

30.62%

29 - 90 days

3714

59.66%

> 90 days

605

9.72%

Total

6225

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

124

79.49%

Chronic toxicity

Reproductive ecotoxicity

32

20.51%

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

156

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

54

4.31%

Monoclonal antibody by mouse ascites method

55

4.39%

Other product types

1145

91.31%

Total

1254

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

32566

27.09%

Legislation on medicinal products for veterinary use and their residues

62289

51.82%

Medical devices legislation

138

0.11%

Industrial chemicals legislation

3194

2.66%

Plant protection product legislation

28

0.02%

Biocides legislation

56

0.05%

Food legislation including food contact material

21850

18.18%

Feed legislation including legislation for the safety of target animals, workers and environment

68

0.06%

Cosmetics legislation

Other legislation

3

0%

Total

120192

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

107209

89.2%

Legislation satisfying national requirements only [within EU]

4112

3.42%

Legislation satisfying Non-EU requirements only

8871

7.38%

Total

120192

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

792724

98.72%

Yes

10252

1.28%

Total

802976

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

41203

5.13%

Mild [up to and including]

415094

51.69%

Moderate

280781

34.97%

Severe

65898

8.21%

Total

802976

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

779035

97.02%

Yes

23941

2.98%

Total

802976

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

512735

63.85%

Genetically altered without a harmful phenotype

243856

30.37%

Genetically altered with a harmful phenotype

46385

5.78%

Total

802976

100.00%



Sweden

Sweden: Narrative 2015

Adjustments in 2018

The European Commission noticed some irregularities in the Swedish statistic for 2015. After being in contact with four users, we have adjusted their reports. In total for 2015 (after the adjustments), 254,789 animal uses were reported, of which 235,961 animal uses were reported as first time use. We have not updated the text below. For updated numbers for 2015 and 2016, see the narrative for 2017.

1. General information on any changes in trends observed since the previous reporting period.

1.1 Number of animals
In 2015 SE 224,979 animals are reported in first time use, compared to 278,885 in 2014. The total figure encompassing reuse is 258,403 for 2015 and 284,170 for 2014.

The most used animal species are mice, followed by fish (mainly zebra fish) and rats. These categories topped the usage also in 2014. The figure for mice is lower compared to 2014, as is the figure for rats and other fish, while the use of zebra fish has increased.

The major part of animals are used within Basic Research (78 %), followed by Translational and applied research (17 %).

1.2 More detailed data through the new statistics

Directive 2010/63/EU and Commission implementing decision 2012/707/EU contain several new objects to be collected in the statistics, for example a more detailed division of research areas. A reason for doing so is to enable identification of more areas within which animals are used, and not ending up aggregating them in an unidentifiable ‘Other’ group.

Earlier reports from both the EU as a whole and SE showed a large proportion of animals being reported under more undefined areas of ‘Other…’ for example Other human diseases. The new more elaborate categories in 2012/707/EU resulted in the 2014 report in a diminishing of the amount of animals being categorised as ‘others’. This is repeated in the 2015 data. To illustrate, the figures from Basic research and Translational and applied research are shown below. Figures in red are the new topics that were introduced through 2012/707/EU.

I.Basic Research (first use and re-use); number of uses 200,580
Oncology 7 %
Cardiovascular Blood and Lymphatic System 14 %
Nervous System 22 %
Respiratory System 1 %
Gastrointestinal System including Liver 2 %
Musculoskeletal System 2 %
Immune System 15 %
Urogenital/Reproductive System 1 %
Sensory Organs (skin, eyes and ears) 2 %
Endocrine System/Metabolism 9 %
Multisystemic 9 %
Ethology / Animal Behaviour /Animal Biology 10 %
Other 6 %

Thus, for 2015, 51 % of basic research could be closer identified thanks to the new division of topics compared to the statistics collected using the former directive. The total use in category Other basic research is 6 % in 2015 compared to 8 % in 2014.

II.Translational and applied research (first use and re-use); number of uses 43,441
Human Cancer 27 %
Human Infectious Disorders 2% 
Human Cardiovascular Disorders 17 %
Human Nervous and Mental Disorders 6 %
Human Respiratory Disorders 15 %
Human Gastrointestinal Disorders including Liver 1 %
Human Musculoskeletal Disorders 1 %
Human Immune Disorders 5 %
Human Urogenital/Reproductive Disorders <1 %
Human Sensory Organ Disorders (skin, eyes and ears) <1 %
Human Endocrine/Metabolism Disorders 7 %
Other Human Disorders 4 %
Animal Diseases and Disorders 10 % 
Animal Welfare < 1%
Diagnosis of diseases 1 % 
Plant diseases 0%
Non-regulatory toxicology and ecotoxicology 5 %

Thus, for 2015, only 4 % of the translational and applied research was specified into more detailed human disorders instead of ending up in Other human disorders, compared to 20 %
in 2014. These have been identified as pharmacokinetic studies, pharmacological analysis of new formulations of already approved pharmaceuticals, pharmacological studies of candidate drugs, research on hemorrhagic chock, skin and transplantation research, hematology, skeleton and cartilage diseases, development of models for sepsis and treatment of severe infections affecting organs and circulation, and development of pharmaceuticals against preeclampsia.

III.Genetic status

Results show that most uses are animals that are genetically altered without a harmful phenotype (49%), followed by not genetically altered (44 %), and finally genetically altered with a harmful phenotype (7 %). This is a slight shift from 2014, where the main use was not genetically altered (51 %), followed by genetically altered without a harmful phenotype (46%), and genetically altered with a harmful phenotype (3%).

IV.Creation of a genetically modified line
The amount of uses in the creation of genetically modified line has increased from 1 % in 2014 to 10 % in 2015.

V.Regulatory use and routine production; number of uses 2,188

SE has a low figure in regulatory use during 2015, in line with previous reports. Most of the animals have been used in toxicity and other safety testing including pharmacology (93 %), mainly used in ecotoxicity (62 %) followed by pharmaco-dynamics (26 %), kinetics (7 %), repeated dose toxicity (4 %) and other toxicity/safety testing (1 %). The remaining 7% under regulatory use and routine production falls under Other efficacy and tolerance testing.

There is a drop in the figures from 2014; from 12,175 uses to 2,188 uses in 2015. This is due to an erroneous reporting in 2014 of regulatory use of roosters (9,664 uses), for more details see 2.ii. These uses were wrongly reported as EU statistics, when they should have been reported in the national statistics only. The error was detected in time for this report, and is thus not repeated for 2015.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

i.    Total number of uses

There is a decrease in the total number of uses. There is, however, no clear reason for the decrease which can be due to normal fluctuations in research efforts and/or financing.

ii.    Species

We see a slight decrease in the percentage of mice being used; 175,962 compared to 197,491 in 2014. During the last years the figure has been approximately the same although slightly decreasing compared to earlier years.

The use of rats decreased from 26,762 in 2014 to 21,907 in 2015. This is in line with the last years where the use has been decreasing.

The use of zebrafish more than doubled from 8,171 in 2014 to 20,519 in 2015. A major reason for this was a significant increase in the use of zebrafish in Basic Research/Multisystemic between the years, from 3,174 uses in 2014 to 16,233 uses in 2015.

The use of other fish has decreased by a third from 21,697 in 2014 to 14,355 in 2015. This is partly explained by a large feeding regime study constituting ca 25 % of the total uses in 2014, as well as one user having a significant decrease in use in 2015. However, there are many users and many different projects, especially during 2014, and the analysis is complex.

The use of domestic fowl decreased from 10,899 in 2014 to 5,266 in 2015. However, what seems like a decrease is in fact an increase – in 2014, SE reported 9,664 domestic fowl, more specifically roosters, used for the production and harvesting of hyaluronic acid from their combs, as EU statistics. In 2015 roosters have been used for the same purpose, however, after due consideration this use has been categorized as non-EU purpose. The roosters used in 2014 were thus erroneously reported as EU statistics. The use in 2015 is now mostly derived from two major studies at one user; one on welfare indicators and one on ecologically produced chicken.

There was a rise in the use of cattle, from 129 in 2014 to 2,097 in 2015. The major part was under 2015 used in Higher education or training for the acquisition, maintenance or improvement of vocational skills – but there was also a specific project on raw milk during the year causing the figures to increase.

Other rodents decreased slightly from 5,296 in 2014 to 3,323 in 2015. The decrease was almost in total due to a lower use by the same user and at least in part due a misreporting of insectivores under Other rodents, instead of reporting these under Other mammals. This was corrected in the 2015 report leading to a higher amount in this area; Other mammals doubled from 1,128 in 2014 to 2,104 in 2015.

Under 2015 57 uses of ferrets were reported whereas none was reported for 2014. The ferrets were used in a study under Basic research/Nervous system.

The use of horses, donkeys and cross-breads increased from 58 in 2014 to 275 in 2015. The increase is to the major part due to a large study on Translational and applied research/Animal Diseases and Disorders.

The use of pigs has increased from 585 in 2014 to 1,625 in 2015.This change is in part due to studies performed by users who did not use pigs in 2014, and also partly to an increase in the use of pigs for Higher education or training for the acquisition, maintenance or improvement of vocational skills by 420 uses.

The use of reptiles increased from 9 uses in 2014 to 50 in 2015. Both years the use took place in individual studies under Basic Research/ Ethology/Animal Behaviour/Animal Biology; one on European grass snake (Natrix natrix) (2014) and the other on the common European adder (Vipera berus) (2015).

Under 2015 600 uses of Rana were reported whereas none was reported for 2014. The Rana were used in a study for Protection of the natural environment in the interests of the health or welfare of human beings or animals.

The use of Xenopus decreased from 1,598 in 2014 to 574 in 2015. In 2014 more users performed studies on Xenopus, and there were also larger studies in Translational and applied research/ Non-regulatory toxicology and ecotoxicology as well as studies of the ability of the nervous system and the locomotion to heal themselves and gene function under Basic Research/Other.

 The use of Other amphibians decreased from 2,857 uses in 2014 to 1,894 in 2015. In 2014 there was a large study of pH-changes in aquaria under Basic Research/Ethology/Animal Behaviour /Animal Biology with 2,080 uses, but the smaller decrease in 2015 does not reflect this entirely. A further explanation is that more animals were used in studies of the ability of the nervous system and the locomotion to heal themselves and gene function under Basic Research/Other in 2015 compared to 2014. 

iii.    Use in specific areas

The major part of animals are used within Basic Research (78 %), followed by Translational and applied research (17 %), Protection of the natural environment in the interests of the health or welfare of human beings or animals (2 %), Higher education or training for the acquisition, maintenance or improvement of vocational skills (1 %), Regulatory use and Routine production (1 %), Preservation of species (<1 %), and finally Maintenance of colonies of established genetically altered animals, not used in other procedures (<1 %). This is in close correlation with figures from 2014, with the exception of Preservation of species which had decreased from 3 % to less than 1 % in 2015.The figures concerning Regulatory use and Routine production show a decrease from 4 % to 1 % in 2015, however, the 2014 figure is too high due to an erroneous report (for explanation see 1.2.v. and 2.ii.), therefore it is not a true decrease.

A comparison of specific areas under Basic research 2015 and 2014 shows many areas exhibit close correlation between the two years. There is a slight decrease in
Cardiovascular Blood and Lymphatic System (14 % vs 19 %), Nervous System (22 % vs 30 %), Urogenital/Reproductive System (1 % vs 2 %) and Other basic research (6 % vs 8%). There is a slight increase in Gastrointestinal System including Liver (2 % vs 1 %), Immune System (15 % vs 12%), Sensory Organs (skin, eyes and ears) (2 % vs 1%) Multisystemic (9 % vs 7%), and Ethology/Animal Behaviour/Animal Biology (10 % vs 4 %). However, it is too early to tell if these changes are trends or simply normal fluctuations in research.

Furthermore, a comparison of specific areas under Translational and applied research 2015 and 2014 also shows close correlation between the two years. There is a slight decrease in Human Nervous and Mental Disorders (6 % vs 7 %), Human Respiratory Disorders (15 % vs 16 %), Other Human Disorders (4 % vs 20 %), Animal Diseases and Disorders (10 % vs 11 %), Diagnosis of diseases (1 % vs 2 %), and Non-regulatory toxicology and ecotoxicology (5 % vs 8 %). There is a slight increase in Human Cancer (27 % vs 19 %), Human Infectious Disorders (2 % vs 1 %), Human Cardiovascular Disorders (17 % vs 12 %), Human Immune Disorders (5 % vs 3 %), and Human Endocrine/Metabolism Disorders (7 % vs 0 %). As for Basic research it is too early to tell if these changes are trends or simply normal fluctuations in research.

iv.    Reuse

Reuse is 13 % in 2015 compared to 2 % in 2014. The higher figure could indeed to some extent be due to a higher reuse, however, analysis of data has clarified that it is at least in part due to a misconception of the definition of reuse with some users, leading to animals erroneously being recorded as reuse when they should not have been. Where it has been possible to correct the figures this has been done, but this was not possible in all cases. Information work has been initiated to clear this misunderstanding in future reporting.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The results for 2015 show that (51 %) procedures are moderate followed by mild [up to and including] (36 %), non-recovery (6 %) and finally severe (7 %). It follows rather closely the figures from 2014, where (56 %) procedures were moderate followed by mild [up to and including] (28 %), non-recovery (9 %) and finally severe (7 %). No conclusions can be drawn from the material at this stage.

 
4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The Swedish Board of Agriculture is since 2015 building a competence centre for the 3Rs. The Swedish National Committee will act as the steering group for the centre, which will be in place late 2017.

The purpose of the 3Rs centre is to promote and coordinate the work on alternative methods to animal experiments together with stakeholders, such as regional ethics committees, authorities, researchers and animal welfare organizations. The 3Rs centre shall obtain, provide and actively disseminate information on the 3Rs. The Swedish Board of Agriculture considers that the national work with the 3Rs, including the project evaluation process will be considerably strengthened through the establishment of the 3Rs centre.

Under 2016, the Swedish National Committee for the protection of animals used for scientific purposes held two courses for the members of the regional ethics committees together with the Swedish Board of Agriculture. The National Committee also held a meeting with the animal welfare bodies. These efforts were made towards increasing the consciousness of the 3Rs.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

5.1 Other animals

i. Fish

41 % of the reported fish constitutes of Other fish. Many different species are used, e.g. three-spined stickleback (Gasterosteus aculeatus), perch (Perca fluviatilis), eel (Anguilla anguilla), brown trout (Salmo trutta), rainbow trout (Oncorhynchus mykiss), Cyclostomata, salmon (Salmo salar), pike (Esox lucius) and burbot (Lota lota).

These were used mainly for Basic research/Ethology/Animal behaviour/animal biology, but also in f e Protection of the natural environment in the interests of the health or welfare of human beings or animals and Preservation of species. In translational and applied research fish were used in Non-regulatory toxicology and ecotoxicology.

ii. Amphibians

More than half, 62 %, of the amphibians are registered as Other amphibians. These are Iberian ribbed newt (Pleurodeles waltl), eastern newt (Notophthalmus viridescens), European green toad (Bufotes viridis) and natterjack toad (Epidalea calamita).

Iberian ribbed newt and eastern newt have been used in Other basic research, more specifically studies of the ability of the nervous system and the locomotion to heal themselves and gene function. European green toad and natterjack toad have been used in Basic Research/Ethology /Animal Behaviour /Animal Biology.

iii. Birds

A large percentage, 55 %, among the birds constitutes of Other birds. These are Old World flycatchers (Muscicapidae), collared flycatcher (Ficedula albicollis), Eurasian blue tit (Cyanistes caeruleus), great tit (Parus major), mallard (Anas platyrhyncos), northern wheatear (Oenanthe oenanthe), Eurasian teal (Anas crecca), bean goose (Anser fabalis), willow warbler (Phylloscopus trochilus), golden eagle (Aquila chrysaetos), Eurasian wryneck (Jynx torquilla), Eurasian skylark (Alauda arvensis), carrion crow (Corvus [corone] corone), hooded crow (Corvus [corone] cornix), common crane (Grus grus), Eurasian wigeon (Anas penelope), tufted duck (Aythya fuligula), common pochard (Aythya ferina), and northern pintail (Anas acuta).

Approximately half of these birds have been used in Basic research/Other, more specifically for blood sampling for gene analyses and prevalence of malaria, infections in wild animals, or behavioural studies without restraining equipment. The remaining half has been used in Basic Research/ Ethology / Animal Behaviour /Animal Biology.

iv. Carnivores

Among the carnivores SE had a large percentage (38 %) of Other carnivores. These are raccoon dog (Nyctereutes procyonoides), fox (Vulpes vulpes), American mink (Neovison vison), Eurasian lynx (Lynx lynx), wolf (Canis lupus) and wolverine (Gulo gulo).

They have all been used in Basic research/Ethology/Animal behaviour/animal biology, apart from the racoon dogs, which have been used in Translational and applied research/Animal Welfare.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

There has been no such case in SE up to this date.

Sweden: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

175904

69.04%

Rats

21907

8.6%

Guinea-Pigs

482

0.19%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

Rabbits

446

0.18%

Cats

23

0.01%

Dogs

115

0.05%

Ferrets

57

0.02%

Other carnivores

118

0.05%

Horses, donkeys and cross-breeds

275

0.11%

Pigs

1625

0.64%

Goats

Sheep

52

0.02%

Cattle

2097

0.82%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

7

0%

Rhesus monkey

1

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

1871

0.73%

Domestic fowl

5266

2.07%

Other birds

6551

2.57%

Reptiles

50

0.02%

Rana

600

0.24%

Xenopus

574

0.23%

Other Amphibians

1894

0.74%

Zebra fish

20519

8.05%

Other Fish

14355

5.63%

Cephalopods

Total

254789

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

190472

80.72%

Animals born in the EU but not at a registered breeder

39960

16.94%

Animals born in rest of Europe

249

0.11%

Animals born in rest of world

5277

2.24%

Total

235958

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

3

100%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

3

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

3

100%

Self-sustaining colony

Total

3

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

202450

79.46%

Translational and applied research

39885

15.65%

Regulatory use and Routine production

2188

0.86%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

6280

2.46%

Preservation of species

500

0.2%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

3331

1.31%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

155

0.06%

Total

254789

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

13825

6.83%

Cardiovascular Blood and Lymphatic System

28833

14.24%

Nervous System

44616

22.04%

Respiratory System

1652

0.82%

Gastrointestinal System including Liver

3971

1.96%

Musculoskeletal System

4597

2.27%

Immune System

29358

14.5%

Urogenital/Reproductive System

2892

1.43%

Sensory Organs (skin, eyes and ears)

3495

1.73%

Endocrine System/Metabolism

18578

9.18%

Multisystemic

18073

8.93%

Ethology / Animal Behaviour /Animal Biology

19510

9.64%

Other basic research

13050

6.45%

Total

202450

100.00%



Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

11929

29.91%

Human Infectious Disorders

883

2.21%

Human Cardiovascular Disorders

7234

18.14%

Human Nervous and Mental Disorders

2777

6.96%

Human Respiratory Disorders

6436

16.14%

Human Gastrointestinal Disorders including Liver

386

0.97%

Human Musculoskeletal Disorders

263

0.66%

Human Immune Disorders

2053

5.15%

Human Urogenital/Reproductive Disorders

117

0.29%

Human Sensory Organ Disorders (skin, eyes and ears)

109

0.27%

Human Endocrine/Metabolism Disorders

2914

7.31%

Other Human Disorders

1636

4.1%

Animal Diseases and Disorders

728

1.83%

Animal Welfare

18

0.05%

Diagnosis of diseases

239

0.6%

Plant diseases

Non-regulatory toxicology and ecotoxicology

2163

5.42%

Total

39885

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

Routine production

Other efficacy and tolerance testing

144

6.58%

Toxicity and other safety testing including pharmacology

2044

93.42%

Total

2188

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

Batch safety testing

Other quality controls

Pyrogenicity testing

Total

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

80

3.91%

Kinetics

145

7.09%

Pharmaco-dynamics (incl safety pharmacology)

535

26.17%

Ecotoxicity

1260

61.64%

Other toxicity/safety testing

24

1.17%

Total

2044

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

80

100%

Total

80

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

1260

100%

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

1260

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

928

42.41%

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

1260

57.59%

Cosmetics legislation

Other legislation

Total

2188

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

928

42.41%

Legislation satisfying national requirements only [within EU]

1260

57.59%

Legislation satisfying Non-EU requirements only

Total

2188

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

235961

92.61%

Yes

18828

7.39%

Total

254789

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

11034

4.33%

Mild [up to and including]

92991

36.5%

Moderate

132628

52.05%

Severe

18136

7.12%

Total

254789

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

228629

89.73%

Yes

26160

10.27%

Total

254789

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

109855

43.12%

Genetically altered without a harmful phenotype

126664

49.71%

Genetically altered with a harmful phenotype

18270

7.17%

Total

254789

100.00%



Sweden: Narrative 2016

Adjustments in 2018

The European Commission noticed some irregularities in the Swedish statistic for 2016. After being in contact with four users, we have adjusted their reports. In total for 2016 (after the adjustments), 345,433 animal uses were reported, of which 339,299 animal uses were reported as first time use. We have not updated the text below. For updated numbers for 2015 and 2016, see the narrative for 2017.

1. General information on any changes in trends observed since the previous reporting period

1.1 Number of animals

 
For 2016, 344,255 uses were reported as first time use, compared to 224,979 in 2015. The total figure encompassing re-use was 258,403 for 2015 and 350,664 for 2016. The large part of the increase (93 %) constitutes of mice – 85,885 more mice used in 2016 compared to 2015 (first time use and re-use).

Re-Use

2015

2016

Number of

%

Number of

%

No

224,979

87

344,255

98

Yes

33,424

13

6,409

2

Totally

258,403

100

350,664

100

The most used animal species were mice, followed by zebra fish, rats and other fish. These four categories topped the usage also in 2015. The uses of mice, zebra fish and other fish increased numerically compared to 2015 (mice: 175,962 vs 261,847, zebrafish: 20,519 vs 24,607, and other fish: 14,355 vs 18,024). The use of rats was similar in 2015 and 2016 (21,907 vs 21,218). For the first time more uses of zebra fish than rats were reported (24,607 compared to 21,218). The major part of animals are used within Basic Research (81 %), followed by Translational and applied research (14 %).

1.2 More detailed data through the new statistics



Directive 2010/63/EU and Commission implementing decision 2012/707/EU contain several new objects to be collected in the statistics, for example a more detailed division of research areas. A reason for doing so is to enable identification of more areas within which animals are used, and not ending up aggregating them in an unidentifiable ‘Other’ group.

 
Earlier reports from both the EU as a whole and SE showed a large proportion of animals being reported under more undefined areas of ‘Other…’ for example Other human diseases. The new more elaborate categories in 2012/707/EU resulted in the 2014 report in a diminishing of the amount of animals being categorised as ‘others’. This pattern is repeated in the 2015 as well as the 2016 data. To illustrate, the figures from Basic research and Translational and applied research are shown below. Figures in red are the new topics that were introduced through 2012/707/EU.



VI.Basic Research (first use and re-use)

Basic research

2015

2016

Number of

%

Number of

%

Oncology

13,825

7

28,930

10

Cardiovascular Blood and Lymphatic System

28,833

14

39,229

14

Nervous System

44,616

22

51,837

18

Respiratory System

1,652

1

2,732

1

Gastrointestinal System including Liver

3,971

2

6,256

2

Musculoskeletal System

4,597

2

7,120

3

Immune System

29,358

15

42,537

15

Urogenital/Reproductive System

2,892

1

2,658

1

Sensory Organs (skin, eyes and ears)

3,495

2

4,523

2

Endocrine System/Metabolism

18,578

9

25,651

9

Multisystemic

18,073

9

31,111

11

Ethology / Animal Behaviour /Animal Biology

19,510

10

16,487

6

Other basic research

13,050

6

24,836

9

Totally

202,450

100

283,907

100

Thus, for 2016, 49 % of basic research could be closer identified thanks to the new division of topics compared to the statistics collected using the former directive. The total use in category Other basic research was 9 % in 2016 compared to 6 % in 2015.

VII.Translational and applied research (first use and re-use)

Translational and applied research

2015

2016

Number of

%

Number of

%

Human Cancer

11,929

27

14,014

28

Human Infectious Disorders

883

2

973

2

Human Cardiovascular Disorders

7,234

17

5,606

11

Human Nervous and Mental Disorders

2,777

6

4,523

9

Human Respiratory Disorders

6,436

15

5,806

11

Human Gastrointestinal Disorders including Liver

386

1

279

1

Human Musculoskeletal Disorders

263

1

246

<1

Human Immune Disorders

2,053

5

1,441

3

Human Urogenital/Reproductive Disorders

117

<1

75

<1

Human Sensory Organ Disorders (skin, eyes and ears)

109

<1

292

1

Human Endocrine/Metabolism Disorders

2,914

7

3,288

7

Other Human Disorders

1,636

4

3,802

8

Animal Diseases and Disorders

4,284

10

1,160

2

Animal Welfare

18

<1

6,578

13

Diagnosis of diseases

239

1

530

1

Plant diseases

0 

0

0

0

Non-regulatory toxicology and ecotoxicology

2,163

5

1,955

4

Totally

43, 441

100

50,568

100

For 2016, 38 % of the translational and applied research could be closer identified thanks to the new division of topics compared to the statistics collected using the former directive. For 2016, 8% were classified as Other human disorders, compared to 4% in 2015.

 
These have been identified among others as the following: Studies on anti-bacterial therapies against wound infections, research and development of products or devices in human medicine, understanding of growth mechanisms to treat children with growth abnormalities, creation of cartilage and skin in animal models, skeleton and cartilage diseases, studies on pharmaceuticals for patients with disturbed skin barriers e.g. psoriasis and eczema, research on haematology, recreation of human organs using tissue therapy for transplantation, creating individually designed blood vessels using tissue therapy for transplantation, test of substances to prevent rejection of transplanted organs, and pharmacokinetic studies of new formulations of registered pharmaceuticals.

VIII.Genetic status
For 2016 most uses were of animals that were genetically altered without a harmful phenotype (52%), followed by not genetically altered (42 %), and finally genetically altered with a harmful phenotype (6 %). The figures are similar to the distribution in 2015.

Genetic Status

2015

2016

Number of

%

Number of

%

Not genetically altered

113,411

44

146,110

42

Genetically altered without a harmful phenotype

126,722

49

182,261

52

Genetically altered with a harmful phenotype

18,270

7

22,293

6

Totally

258,403

100

350,664

100

IX.Creation of a genetically modified line
The amount of uses for the creation of genetically modified lines were 7 % for 2016 compared to 10 % in 2015.

X.Regulatory use and routine production

SE had a low figure in regulatory use during 2016 as in 2015. Most of the animals have been used in Toxicity and other safety testing including pharmacology (55 %), and Quality control (incl batch safety and potency testing) (40 %).

 

Regulatory use and routine production

2015

2016

Number of

%

Number of

%

Quality control (incl batch safety and potency testing)

0

0

1,048

40

Other efficacy and tolerance testing

144

7

120

5

Toxicity and other safety testing including pharmacology

2,044

93

1,426

55

Routine production

0

0

5

<1

Totally

2,188

100

2,599

100

2. Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.


i.    Total number of uses



There is an increase in the total number of uses reported, 350,664 uses in 2016 compared to 258,403 uses in 2015. The absolutely largest part of the increase (93 %) constitutes of mice – 85,885 more mice used in 2016 compared to 2015 (first time use and re-use).

ii.    Species

There are increases as well as decreases in the number of uses in many of the species, however some of the species remain on the same level as the previous year. It is, however, difficult in most cases to determine the reasons behind the changes and also too early into the new reporting in accordance with Commission decision 2012/707/EU to tell if either increases or decreases are true significant differences that will prevail over time. We present data from 2014 to 2016 to illustrate the fluctuations over the past three year.

As discussed above, there was a large increase in number of mice uses being reported for 2016 (261,847 uses, 75 %) compared to 2015 (175,962 uses, 68 %). Much of this increase is due to a few users reporting considerably higher numbers for 2016 compared to 2015. In one case there is an increase of approximately 30,000 uses, and in another around 25,000 uses. The reason for this is unknown, but could be due to increased research funding, but also a mere consequence of the continuously rising use of mice in research that has been observed for the last decades.



Other rodents decreased from 3,323 uses in 2015 to 63 in 2016. All uses in 2016 were reported as Basic Research while all uses in 2015 was reported from one single user as Translational and Applied Research, more specifically as Animal Diseases and Disorders.

 
Cats increased from 23 uses in 2015 (all in Basic Research/Musculoskeletal System) to 94 uses in 2016 (54 uses in Basic Research/Musculoskeletal System and 40 uses in Translational and applied research/Animal Diseases and Disorders).

Dogs increased from 115 uses in 2015 to 204 uses in 2016. For both years most uses were reported as Translational and applied research. More specifically, in 2015, Human Endocrine/ Metabolism Disorders (83 uses), Human Respiratory Disorders (7 uses), Non-regulatory toxicology and ecotoxicology (14 uses), Human Cardiovascular Disorders (5 uses), and Diagnosis of diseases (2 uses). More specifically, in 2016,Animal Diseases and Disorders (128 uses), Diagnosis of diseases (21 uses), Human Infectious Disorders (6 uses), Human Cardiovascular Disorders (5 uses) and Non-regulatory toxicology and ecotoxicology (4 uses). The remaining uses in 2015 were reported in Basic Research/Cardiovascular Blood and Lymphatic System (5 uses), and in 2016 in Higher education or training for the acquisition, maintenance or improvement of vocational skills (24 uses), Basic Research/Other (12 uses), and Regulatory use and Routine production/Toxicity and other safety testing including pharmacology/Kinetics (4 uses). The wide distribution between many different categories makes it difficult to find clear reasons for the increase.

Other mammals decreased from 2,104 uses in 2015 to 427 uses in 2016. The main difference depends on the 1,500 uses of reindeer in 2015, and none in 2016. Ethology/Animal Behaviour/Animal Biology was the most common purpose in both years; 1,871 uses in 2015 and 416 uses in 2016.

Rabbits increased from 446 uses in 2015 to 1,447 uses in 2016. Most uses of rabbits in 2016 concerned Basic Research (1,391 uses), more specifically Other basic research (885 uses) and Respiratory System (409 uses).


Horses/donkeys increased from 275 uses in 2015 to 824 uses in 2016. Most uses of horses/donkeys 2016 was reported as Translational and Applied Research (741 uses), more specifically as Animal Diseases and Disorders.

Domestic fowls decreased from 5,266 in 2015 to 971 in 2016. In 2016 most uses were reported in Translational and applied research (586 uses), whereas 385 uses were reported in Basic research. The more specific areas were diverse. Under Basic research; Sensory Organs (skin, eyes and ears) (144 uses), Ethology / Animal Behaviour /Animal Biology (105 uses), Cardiovascular Blood and Lymphatic System (84 uses), Other basic research (polyclonal antibodies) (37 uses), and Endocrine System/ Metabolism (15 uses). Under Translational: Human Gastrointestinal Disorders including Liver (240 uses), Non-regulatory toxicology and ecotoxicology (105 uses), Human Respiratory Disorders (90 uses), Animal Diseases and Disorders (90 uses) and Diagnosis of diseases (61 uses). In 2015 most uses were reported under Basic research, more specifically Ethology / Animal Behaviour /Animal Biology (4,140 uses, of which 3,240 uses are reported in a study on welfare indicators and 600 uses on ecologically produced chicken) and Nervous System (120 uses). Remaining uses were reported under Translational and applied research; Animal Diseases and Disorders (475 uses), Non-regulatory toxicology and ecotoxicology (351 uses) and Diagnosis of diseases (180 uses).

 
Other birds increased from 6,551 in 2015 to 11,583 in 2016. Almost all uses were reported as Basic research. In 2015, 3,008 uses were reported in Ethology/Animal Behaviour/Animal Biology, and 3,543 uses in Other Basic Research (blood sampling for gene analyses and prevalence of malaria, 2,969 uses; infections on wild animals, 553 uses; behavioural studies, 21 uses). In 2016, 4,570 uses were reported in Ethology/Animal Behaviour/Animal Biology. The large increase for 2016 is found under Other Basic Research with 6,940 uses reported (blood sampling for genetical analyses, 3,486; blood sampling, 3,072 uses; infections on wild animals, 365 uses; and behavioural studies, 17 uses).  Remaining uses were reported under Musculoskeletal System (8 uses), Sensory organs (4 uses) and Translational and applied research, Animal Diseases and Disorders (61 uses).



Reptiles increased from 50 in 2015 to 380 in 2016. All were used in Basic research, more specifically, in 2015 in Ethology / Animal Behaviour /Animal Biology, and in 2016 in the Other category; 300 uses in evolutionary biology and 80 uses for blood sampling and marking.

 
The use of Other amphibians increased from 1,894 in 2015 to 3,923 in 2016. All were reported under Basic research. In 2015, 1,236 uses were reported for studies of the ability of the nervous system and the locomotion to heal themselves and gene function compared to 1,624 in 2016. In 2016, 1,320 uses of moor frog (Rana arvalis) were reported in Basic Research/Ethology/Animal Behaviour/Animal Biology, and another study in 2016 reported 553 uses for how the chytrid fungus Batrachochytrium dendrobatidis affects Swedish amphibians. Remaining uses were reported in the Other category for 2016 (426 uses, 130 of these for marking) and in Ethology/Animal Behaviour/Animal Biology for 2015 (658 uses).

Animal group

Animal species

2014

2015

2016

Rodents

Mice

197,491

175,962

261,847

Rats

26,762

21,907

21,218

Guinea-Pigs

663

482

422

Hamsters (Syrian)

0

0

0

Hamsters (Chinese)

0

0

0

Mongolian gerbil

0

0

0

Other rodents

5,296

3,323

63

Lagomorphs

Rabbits

571

446

1,447

Carnivores

Cats

28

23

94

Dogs

111

115

204

Ferrets

0

57

0

Other carnivores

91

118

167

Ungulates

Horses, donkeys and cross-breeds

58

275

824

Pigs

585

1,625

1,840

Goats

0

0

58

Sheep

51

52

27

Cattle

129

2,097

1,436

Primates

Prosimians

0

0

0

Marmosets and tamarins

0

0

0

Cynomolgus monkey

3

7

10

Rhesus monkey

0

1

28

Vervets (Chlorocebus spp.)

0

0

0

Baboons

0

0

0

Squirrel monkey

0

0

0

Other species of New World Monkeys (Ceboidea)

0

0

0

Other species of Old World Monkeys (Cercopithecoidea)

0

0

0

Other species of non-human primates

0

0

0

Apes

0

0

0

Other mammals

Other mammals

1,128

2,104

427

Birds

Domestic fowl

10,899

5,266

971

Other birds

5,972

6,551

11,583

Reptiles

Reptiles

9

50

380

Amphibians

Rana

0

600

623

Xenopus

1,598

574

441

Other amphibians

2,857

1,894

3,923

Fish

Zebra fish

8,171

20,519

24,607

Other fish

21,697

14,355

18,024

Cephalopods

Cephalopods

0

0

0

Total uses

284,170

258,403

350,664

                       

iii.    Use in specific areas

The uses in overall, in percentages, were similar in 2015 and 2016, but the percentages of two of the less frequent reported categories have changed between 2015 and 2016. The category Protection of the natural environment in the interests of the health or welfare of human beings or animals has dropped from 2.4 % (6,280 uses) to 0.7 % (2,759 uses). Maintenance of colonies of established genetically altered animals, not used in other procedures has increased from 0.1 % (213 uses) to 1.6 % (5,676 uses).

The percentages for the specific areas under both Basic research and Translational and applied research 2015 and 2016 are similar. The most notable differences are for Animal Diseases and Disorders which were reported for 10 % (4,284 uses) in 2015 and 2 % (1,160 uses) in 2016 and Animal Welfare which increased from <1 % (18 uses) in 2015 to 13 % (6,578 uses) in 2016.

It is too early to tell if these changes are trends or simply normal fluctuations in research.

iv.    Re-use

Re-use were reported for 2 % of the uses in 2016. For 2015, that number was 13 %; that higher figure could indeed to some extent be due to a higher re-use, however, analysis of data has clarified that it is at least in part due to a misconception of the definition of re-use with some users, leading to animals erroneously being recorded as re-used when they should not have been. Figures were corrected where it was possible, which was unfortunately not always the case. In order to improve the future quality of the reporting, information efforts were initiated, that are believed to have led to a more accurate reporting on re-use in the 2016 statistics.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

The proportion of moderate severity has increased from 51 % in 2015 to 58 % in 2016, while the proportions of Mild and Non-recovery have decreased. No conclusions can be drawn from the material at this stage.

Severity

2015

2016

Number of

%

Number of

%

Non-recovery

14,648

6

6,427

2

Mild (up to and including)

92,991

36

112,034

32

Moderate

132,628

51

202,626

58

Severe

18,136

7

29,577

8

Totally

258,403

100

350,664

100

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.



The Swedish parliament decided in late 2016 to finance a competence centre for the 3Rs, placed at the Swedish Board of Agriculture. The Swedish National Committee will act as the steering group for the centre. The centre will have its official opening on the 21th of November 2017.

The purpose of the 3Rs centre is to promote and coordinate the work on alternative methods to animal experiments together with stakeholders, such as regional ethics committees, authorities, researchers and animal welfare organizations. The 3Rs centre shall obtain, provide and actively disseminate information on the 3Rs. The Swedish Board of Agriculture considers that the national work with the 3Rs, including the project evaluation process will be considerably strengthened through the establishment of the 3Rs centre.

Under 2017, the Swedish National Committee for the protection of animals used for scientific purposes held one course for the members of the regional ethics committees together with the Swedish Board of Agriculture. The National Committee also held a meeting with the animal welfare bodies. These efforts were made towards increasing the consciousness of the 3Rs.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

5.1 Other animals



i. Fish

42 % of the reported fish constitutes of Other fish. Of the 18,024 uses of Other fish most are reported as three-spined stickleback (Gasterosteus aculeatus, 4,339 uses), brown trout (Salmo trutta, 3,983 uses), salmon (Salmo salar, 3,417 uses), perch (Perca fluviatilis, 1,443 uses) and common roach (Rutilus rutilus, 1,358 uses).

The fish in this category were used mainly for Basic research/Ethology/Animal behaviour/animal biology (8,303 uses) and in Translational and applied research/Animal Welfare (6,566 uses), but also in Protection of the natural environment in the interests of the health or welfare of human beings or animals (2,159 uses). Remaining uses are reported in Basic research (Gastrointestinal System including Liver, 294 uses; Nervous system, 66 uses; and Cardiovascular Blood and Lymphatic System, 29 uses); Translational and applied research (Diagnosis of disease, 154 uses; and Non-regulatory toxicology and ecotoxicology, 70 uses) and Higher education or training for the acquisition, maintenance or improvement of vocational skills (13 uses).  

 

ii. Amphibians

79 %, of the amphibians are registered as Other amphibians. The category (3,923 uses) consists mostly of moor frog (Rana arvalis, 1,614 uses), Iberian ribbed newt (Pleurodeles waltl, 1,570 uses), but also common toad (Bufo bufo, 500 uses), natterjack toad (Epidalea calamita, 143 uses), eastern newt (Notophthalmus viridescens, 54 uses), European green toad (Bufotes virides, 36 uses) and edible frog (Pelophylax kl esculentus, 6 uses).

Most other amphibians have been used in Other basic research. Iberian ribbed newt and eastern newt have been used in studies of the ability of the nervous system and the locomotion to heal themselves and gene function. Furthermore, the common toad, moor frog, European green toad, natterjack toad and edible frog have been used to understand how the chytrid fungus Batrachochytrium dendrobatidis affects Swedish amphibians. 1,320 uses of moor frog were categorised as Basic Research/Ethology /Animal Behaviour /Animal Biology.

iii. Birds

A large percentage, 92 %, among the birds constitutes of Other birds. These (11,583 uses) consist mostly of Old World flycatchers (Muscicapidae, 3,486 uses), followed by collared flycatcher (Ficedula albicollis, 1,750 uses), Eurasian blue tit (Cyanistes caeruleus, 1,962 uses), European pied flycatcher (Ficedula hypoleuca, 766 uses) and marsh tit (Poecile palustris, 641 uses).

60 % of these birds have been used in Basic research/Other, more specifically for blood sampling for gene analyses, infections in wild animals, or behavioural studies without restraining equipment. The remaining birds have been used in Basic Research: Ethology / Animal Behaviour /Animal Biology (4,570 uses), Musculoskeletal System (8 uses) and Sensory Organs (4 uses); and in Translational and applied research/Animal Diseases and Disorders (61 uses).

iv. Carnivores
Among the carnivores SE had a large percentage (36 %) of Other carnivores. These (167 uses) are mainly brown bear (Ursus arctos, 68 uses) and raccoon dog (Nyctereutes procyonoides, 60 uses), but also fox (Vulpes vulpes, 17 uses), American mink (Neovison vison, 12 uses), wolf (Canis lupus, 6 uses), and wolverine (Gulo gulo, 4 uses).


They have all been used in Basic research/Ethology/Animal behaviour/animal biology, apart from the American mink, used in Translational and applied research/Animal Welfare.

5.2 Other legislation

 
14 % of the uses in Testing by legislation are reported under Other legislation. These constitute 320 uses of rainbow trout (Oncorhyncus mykiss) and 50 uses of three-spined stickleback (Gasterosteus aculeatus) in Regulatory use and Routine production /Toxicity and other safety testing including pharmacology/Acute and sub-acute/Non lethal methods, Legislation satisfying EU requirements. The user has identified this legislation as concerning biotoxicity.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.



There has been no such case in SE up to this date.

Sweden: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

255949

74.24%

Rats

21218

6.15%

Guinea-Pigs

422

0.12%

Hamsters (Syrian)

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

63

0.02%

Rabbits

1447

0.42%

Cats

94

0.03%

Dogs

204

0.06%

Ferrets

Other carnivores

167

0.05%

Horses, donkeys and cross-breeds

824

0.24%

Pigs

1840

0.53%

Goats

58

0.02%

Sheep

27

0.01%

Cattle

1436

0.42%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

10

0%

Rhesus monkey

28

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

427

0.12%

Domestic fowl

971

0.28%

Other birds

11583

3.36%

Reptiles

380

0.11%

Rana

623

0.18%

Xenopus

441

0.13%

Other Amphibians

3923

1.14%

Zebra fish

24607

7.14%

Other Fish

18024

5.23%

Cephalopods

Total

344766

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

261665

77.28%

Animals born in the EU but not at a registered breeder

67459

19.92%

Animals born in rest of Europe

5884

1.74%

Animals born in rest of world

3586

1.06%

Total

338594

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

38

100%

Animals born in America

Animals born in Africa

Animals born elsewhere

Total

38

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

38

100%

Self-sustaining colony

Total

38

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

283240

82.15%

Translational and applied research

50568

14.67%

Regulatory use and Routine production

2599

0.75%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

2759

0.8%

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

5155

1.5%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

445

0.13%

Total

344766

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

28930

10.21%

Cardiovascular Blood and Lymphatic System

39229

13.85%

Nervous System

51837

18.3%

Respiratory System

2732

0.96%

Gastrointestinal System including Liver

6256

2.21%

Musculoskeletal System

7120

2.51%

Immune System

41870

14.78%

Urogenital/Reproductive System

2658

0.94%

Sensory Organs (skin, eyes and ears)

4523

1.6%

Endocrine System/Metabolism

25651

9.06%

Multisystemic

31111

10.98%

Ethology / Animal Behaviour /Animal Biology

16487

5.82%

Other basic research

24836

8.77%

Total

283240

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

14014

27.71%

Human Infectious Disorders

973

1.92%

Human Cardiovascular Disorders

5606

11.09%

Human Nervous and Mental Disorders

4523

8.94%

Human Respiratory Disorders

5806

11.48%

Human Gastrointestinal Disorders including Liver

279

0.55%

Human Musculoskeletal Disorders

246

0.49%

Human Immune Disorders

1441

2.85%

Human Urogenital/Reproductive Disorders

75

0.15%

Human Sensory Organ Disorders (skin, eyes and ears)

292

0.58%

Human Endocrine/Metabolism Disorders

3288

6.5%

Other Human Disorders

3802

7.52%

Animal Diseases and Disorders

1160

2.29%

Animal Welfare

6578

13.01%

Diagnosis of diseases

530

1.05%

Plant diseases

Non-regulatory toxicology and ecotoxicology

1955

3.87%

Total

50568

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1048

40.32%

Other efficacy and tolerance testing

120

4.62%

Toxicity and other safety testing including pharmacology

1426

54.87%

Routine production

5

0.19%

Total

2599

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

36

3.44%

Other quality controls

Pyrogenicity testing

Batch potency testing

1012

96.56%

Total

1048

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

370

25.95%

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Repeated dose toxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Neurotoxicity

119

8.35%

Kinetics

937

65.71%

Total

1426

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

370

100%

Total

370

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

29 - 90 days

> 90 days

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

5

100%

Monoclonal antibody by mouse ascites method

Other product types

Total

5

100.00%



Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1093

42.05%

Legislation on medicinal products for veterinary use and their residues

1136

43.71%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

370

14.24%

Total

2599

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2594

99.81%

Legislation satisfying national requirements only [within EU]

5

0.19%

Legislation satisfying Non-EU requirements only

Total

2599

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

338632

98.22%

Yes

6134

1.78%

Total

344766

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

6427

1.86%

Mild [up to and including]

111460

32.33%

Moderate

197302

57.23%

Severe

29577

8.58%

Total

344766

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

318807

92.47%

Yes

25959

7.53%

Total

344766

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

145476

42.2%

Genetically altered without a harmful phenotype

176997

51.34%

Genetically altered with a harmful phenotype

22293

6.47%

Total

344766

100.00%

Sweden: Narrative 2017

1. General information on any changes in trends observed since the previous reporting period

Total number of uses

There was a decrease in the total number of uses reported for 2017 (325,838 uses) compared to 2016 (345,433 uses), but more were used than in 2015 (254,789 uses).



Genetic status

The use of genetically altered animals with a harmful phenotype has gradually increased since 2015; with twice as many uses reported in 2017 (36,929 uses, 11%) compared to 2015 (18,270 uses, 7%).

Place of birth

A minority of the animal uses in 2017 were with animals born in rest of the world (2,714 uses, 1%), and the numbers have decreased compared to 2016 (3,586 uses, 1%) and 2015 (5,277 uses, 2%).

Non-human Primate Source

Most uses of non-human primates in 2017 (19 uses, 76%) were of primates born in America. This is in contrast to both 2016 and 2015 were all were born in Asia (2016: 38 uses, 2015: 3 uses).

Species

Hamsters (Syrian) increased to 34 uses in 2017, while none was reported for 2016 and 2015. Most (31 uses) of the uses in 2017 were reported as Translational and Applied Research, mainly Human Endocrine/Metobolism Studies (26 uses). Other rodents decreased to 5 uses in 2017 compared to 63 uses in 2016; none was reported for 2015. All uses in 2017 of other rodents were reported as Preservation of species.

Dogs had 386 uses in 2017, which is an increase compared to 2016 (204 uses) and 2015 (115 uses). For all three years, most uses were reported as Translational and applied research (for 2017 it was 330 uses, 85%). More specifically in 2017: Animal Diseases and Disorders (251 uses), Human Cardiovascular Disorders (45 uses), Human Respiratory Disorders (15 uses), Diagnosis of diseases (10 uses), Human Endocrine/Metobolism Studies (5 uses) and Non-regulatory toxicology and ecotoxicology (4 uses). Also for 2016 Animal Diseases and Disorders were the most reported category in Translational and applied research (785 in 2016, 765 in 2017).

Horses, donkeys and cross-breeds had 41 uses in 2017 which is a large decrease compared to 2016 (824 uses) and 2015 (275 uses). The uses in 2017 was reported as Higher education or training for the acquisition, maintenance or improvement of vocational skills (26 uses) and Basic research (15 uses, of which 8 were for Other basic research and 7 for Respiratory System). A main difference from 2016 is that one user in 2016 reported 741 uses (90%) as Translational and Applied Research (more specifically as Animal Diseases and Disorders).

Goats had 30 uses in 2017, which is about half as many as in 2016 (58 uses); none was reported for 2015. In 2017 most uses were reported in Translational and applied research, more precisely Diagnosis of diseases (20 uses), whereas 10 uses were reported in Basic research. The uses was similar in 2016 except that 24 uses were reported as Higher education or training for the acquisition, maintenance or improvement of vocational skills in 2016.

Domestic fowls had 1,452 uses in 2017, which is an increase compared to 2016 (971 uses), but a decrease compared to 2015 (5,266 uses). In 2017 most uses were reported in Translational and applied research (1,125 uses), more specifically Non-regulatory toxicology and ecotoxicology (653 uses), followed by Animal Diseases and Disorders (130 uses), Human Infectious Disorders (128 uses), and Human Respiratory Disorders (118 uses). Of the reported domestic fowls 327 uses were reported in Basic research, mainly in Cardiovascular Blood and Lymphatic System (200 uses) and Oncology (76 uses). Also in 2016 most fowl uses were reported as Translational and applied research (586 uses), followed by Basic research (385 uses). The more specific areas were diverse in 2016 as well.

No reptiles was reported for 2017, which is a decrease compared to 2016 (380 uses) and 2015 (50 uses). In 2016 all uses were reported as Other basic research, more specifically: evolutionary biology (300 uses) and blood sampling and marking (80 uses).

Rana (a genus of frogs) had 308 uses in 2017, which is about half as many compared to 2016 (623 uses) and 2015 (600 uses). In 2017, the uses were reported as Protection of the natural environment in the interests of the health or welfare of human beings or animals (200 uses), and Translational and applied research, more specifically Non-regulatory toxicology and ecotoxicology (108 uses). For 2015 and 2016 all or almost all (100% respectively 96%) uses were reported as Protection of the natural environment in the interests of the health or welfare of human beings or animals.

Xenopus (a genus of frogs) had 261 uses in 2017, and has had a gradual decrease from 2015 to 2017 (2016: 441 uses and 2015: 574 uses). For 2017 the uses were reported as Basic research (145 uses, all under Nervous System) and Translational and applied research (116 uses, all under Non-regulatory toxicology and ecotoxicology). Both these categories had uses reported in 2015 and 2016 as well.

Other amphibians had 2,694 uses in 2017, which is a decrease compared to 2016 (3,923 uses), but an increase compared to 2015 (1,894 uses). For 2017 most uses were reported as Basic Research (2,574 uses), more specifically Nervous System (1,022 uses), Ethology/Animal Behaviour/Animal Biology (843 uses) and Other basic research (709 uses; all to study how the chytrid fungus Batrachochytrium dendrobatidis affects Swedish amphibians). For 2017 an additional 60 uses were reported as Preservation of species and 60 uses as Translational and applied research, more specifically Non-regulatory toxicology and ecotoxicology. For both 2015 and 2016 all uses were reported under Basic research (Ethology/Animal Behaviour/Animal Biology and Other basic research).

 

Zebra fish has gradually increased since 2015. For 2017 was 29,158 uses reported, compared to 24,607 uses in 2016 and 20,519 uses in 2015. The uses in 2017 were reported as Basic Research (19,057 uses, mainly Cardiovascular Blood and Lymphatic System [7,282 uses] and Multisystemic [7,399 uses]) and Translational and applied research (10,101 uses, mainly

Human Nervous and Mental Disorders [7,000 uses] and Human Endocrine/Metabolism Disorders [300 uses]).

Other fish has gradually increased since 2015. For 2017 was 33,940 uses reported, compared to 18,024 uses in 2016 and 14,355 uses in 2015. For 2017 most uses was reported as Protection of the natural environment in the interests of the health or welfare of human beings or animals (27,302 uses) and Basic Research (5,827 uses, of which 2,900 was in the category Ethology/Animal Behaviour/Animal Biology).



2. Information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof.

The uses in overall are similar 2015-2017. A change is that the category Protection of the natural environment in the interests of the health or welfare of human beings or animals has increased to 27,916 in 2017 compared to 2,759 uses in 2016 and 6,280 uses in 2015. In 2017, 98% of these uses were other fish. Another change is that Maintenance of colonies of established genetically altered animals, not used in other procedures has increased to 1,679 uses in 2017 compared to 445 uses in 2016 and 155 uses in 2015. In 2017, 99% of these uses were mice and all were classified as mild severity.

The number of uses for many of the categories under Basic research are either similar to 2016 or to 2015. A change is that Respiratory System increased to 7,362 uses in 2017 compared to 2,732 uses in 2016 and 1,652 uses in 2015. Gastrointestinal System including Liver has decreased to 1,531 uses from 6,256 uses in 2016 and 3,971 uses in 2015. In addition, the Immune System has decreased; 23,611 uses in 2017 compared to 42,537 uses in 2016.

The number of uses for many of the categories under Translational and applied research are either similar to 2016 or to 2015. A change is that Human Nervous and Mental Disorders increased to 9,737 uses in 2017 compared to 4,523 uses in 2016 and 2,777 uses in 2015. In addition, Human Immune Disorders increased to 9,271 uses in 2017 compared to 1,441 uses in 2016 and 2,053 uses in 2015; and Human Endocrine/Metabolism Disorders increased to 5,687 uses in 2017 compared to 3,288 uses in 2016 and 2,914 uses in 2015.

It is unclear what the changes depends on.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.


The uses with severe severity has gradually increased since 2015, reaching 41,475 uses (13%) in 2017, which is more than twice as many as in 2015 (18,136 uses, 7%). Most uses classified as severe in 2017 were reported as Basic research (79%). Of those, Oncology, Nervous system, Respiratory system and Musculoskeletal System are purpose categories that has increased 2015-2017. Oncology increased from 516 uses in 2015 to 4,854 uses in 2017, Nervous system from 8,375 uses in 2015 to 12,466 uses in 2017, Respiratory system from 0 uses in 2015 to 979 uses in 2017, and Musculoskeletal System from 732 uses in 2015 to 1,895 uses in 2017.

Of the uses classified as severe in 2017 under Translational and applied research (21%), Human Immune disorders increased most (2015: 50 uses; 2017: 7,191 uses) and Human Cancer decreased most (2015: 853 uses; 2017: 33 uses).

25% of the uses reported as severe in 2017 comes from two purposes in two user reports. One of the report has 6,869 uses within Human Immune disorders and the other has 3,316 uses within Nervous System (Basic research).

It is unclear what the changes depends on.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.



Sweden established a 3Rs center for the promotion of the 3Rs. The Swedish 3Rs Center had its official opening on the 21st of November 2017. The 3Rs Center is the executive body of the Swedish National Committee for the Protection of Animals Used for Scientific Purposes. As such, the 3Rs Center assists the Committee in carrying out its tasks by e.g. developing advice on alternative methods, disseminating information on the 3Rs, and supporting the local animal welfare bodies, the regional ethics committees and authorities concerned with animal experiments.

During 2017, two working groups were appointed by the National Committee to develop advice for marking and tagging of fish, and group housing of male mice. While the fish project is entirely based on existing literature, the mice project also includes workshops and a questionnaire targeting animal technicians and researchers.

On 14 June 2017, the Swedish 3Rs Center together with the Users’ Committee and the Ethics and Education Committee held a meeting with Sweden’s animal welfare bodies.

The purpose of the meeting was to establish contact and develop efficient cooperation methods between the animal welfare bodies and the 3Rs Center as the committee’s executive body. The meeting provided an opportunity for the participants to make new contacts, gather new knowledge and acquire new tools to carry out their assignments effectively.

On 17–19 October 2017, the Committee on ethics and education of the National Committee together with the Swedish Centre for Animal Welfare (SCAW) arranged the annual education in ethical evaluation for members of the regional ethics committees. The Swedish 3Rs Center participated with a lecture.

In November 2017, the 3Rs Centre used a quantitative questionnaire to learn more about researchers´ thoughts and implementation of the 3Rs, but also to increase their awareness of the 3Rs and the Swedish 3Rs Centre. The results from the survey shall serve as base for the development of further strategies to promote the 3Rs. The results were presented at the scientific conference Scand-LAS in 2018, and will be published in a report.

The Swedish Government has suggested that the Swedish 3Rs Center support six authorities in their 3Rs work by, for example, compiling and reviewing the authorities’ 3R-related activities and the establishing of 3R-strategies. During 2017, the centre begun working on compiling and analysing these authorities’ 3R-strategies.

The Swedish 3Rs Center created a website during 2017. This is an important channel for disseminating information on the 3Rs. It is accessible via the Swedish Board of Agriculture’s website with its home page: www.jordbruksverket.se/3R. During the development of the website, the focus was on putting together pages with information on what the 3Rs are and why it is important to work with the 3Rs. The website also contains information on the centre’s history, vision, mission and objectives as well as the National Committees and 3Rs centers organisational structure. During 2017 the 3Rs Center started also working on developing more specialised pages with information on, for example, animal welfare bodies, how to apply for research funding for projects linked to the 3Rs as well as links to other organisations that work with animal welfare and 3R-related issues. Those pages were published early in 2018. The 3Rs Center also publishes news and information on its website regarding courses and conferences related to the 3Rs.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Other fish

54% of the reported fish constitutes of other fish. Of the 33,940 uses of other fish most are reported as goldsinny wrasse (Ctenolabrus rupestris, 8,518 uses), corkwing wrasse (Symphodus melops, 6,127 uses), and Atlantic cod (Gadus morhua, 5,224 uses). As mentioned above (section 1), most uses of other fish was reported as Protection of the natural environment in the interests of the health or welfare of human beings or animals (27,302 uses) and Basic Research (5,827 uses, of which 2,900 was in Ethology/Animal Behaviour/Animal Biology).

Other amphibians

83% of the amphibians are registered as other amphibians. This category (2,787 uses) consists mostly of moor frog (Rana arvalis, 1,132 uses), Iberian ribbed newt (Pleurodeles waltl, 956 uses) and common toad (Bufo bufo, 388 uses). As mentioned above (section 1), most uses of other amphibians were reported as Basic Research (2,574 uses), more specifically Nervous System (1,022 uses), Ethology/Animal Behaviour/Animal Biology (843 uses) and Other basic research (709 uses).

Other birds

89% of the birds are reported as other birds. These 11,269 uses consist mostly of European pied flycatcher (Ficedula hypoleuca, 3,511 uses), followed by Eurasian blue tit (Cyanistes caeruleus, 1,882 uses), collared flycatcher (Ficedula albicollis, 1,800 uses), great tit (Parus major, 978 uses), mallard (anas platyrhynchos, 663 uses), and marsh tit (Poecile palustris, 558 uses). Most uses of other birds was reported as Basic research (10,744 uses, of which 10,072 was specified as Ethology/Animal Behaviour/Animal Biology).

Other carnivores

22% of the carnivores was recorded as other carnivores. These 140 uses consist of Arctic fox (Vulpes lagopus, 66 uses), raccoon dog (Nyctereutes procyonoides, 39 uses), red fox (Vulpes vulpes, 22 uses), wolverine (Gulo gulo, 7 uses) and wolf (Canis lupus, 6 uses). The uses of other carnivores was reported as Preservation of species (73 uses), Protection of the natural environment in the interests of the health or welfare of human beings or animals (369 uses), and Basic research (28 uses).

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.



There has been no such case in SE up to this date.

Appendix

The European Commission noticed some irregularities in the Swedish statistic for 2015 and 2016. After being in contact with those users, we have adjusted their reports. We have used the updated numbers for 2015 and 2016 in the present narrative.

Animal group

Animal species

2015

2016

2017

Rodents

Mice

175,904

256,616

221,232

Rats

21,907

21,218

19,437

Guinea-Pigs

482

422

409

Hamsters (Syrian)

0

0

34

Hamsters (Chinese)

0

0

0

Mongolian gerbil

0

0

0

Other rodents

0

63

5

Lagomorphs

Rabbits

446

1,447

1,574

Carnivores

Cats

23

94

104

Dogs

115

204

386

Ferrets

57

0

0

Other carnivores

118

167

140

Ungulates

Horses, donkeys and cross-breeds

275

824

41

Pigs

1,625

1,840

1,557

Goats

0

58

30

Sheep

52

27

35

Cattle

2,097

1,436

1,420

Primates

Prosimians

0

0

0

Marmosets and tamarins

0

0

0

Cynomolgus monkey

7

10

2

Rhesus monkey

1

28

23

Vervets (Chlorocebus spp.)

0

0

0

Baboons

0

0

0

Squirrel monkey

0

0

0

Other species of New World Monkeys (Ceboidea)

0

0

0

Other species of Old World Monkeys (Cercopithecoidea)

0

0

0

Other species of non-human primates

0

0

0

Apes

0

0

0

Other mammals

Other mammals

1,871

427

327

Birds

Domestic fowl

5,266

971

1,452

Other birds

6,551

11,583

11,269

Reptiles

Reptiles

50

380

0

Amphibians

Rana

600

623

308

Xenopus

574

441

261

Other amphibians

1,894

3,923

2,694

Fish

Zebra fish

20,519

24,607

29,158

Other fish

14,355

18,024

33,940

Cephalopods

Cephalopods

0

0

0

Total uses

254,789

345,433

325,838

Severity

2015

2016

2017

Number of

%

Number of

%

Number of

%

Non-recovery

11,034

4

6,427

2

9,324

3

Mild (up to and including)

92,991

37

112,034

32

109,950

34

Moderate

132,628

52

197,395

57

165,089

51

Severe

18,136

7

29,577

9

41,475

13

Totally

258,345

100

345,433

100

325,838

100

Genetic Status

2015

2016

2017

Number of

%

Number of

%

Number of

%

Not genetically altered

109,855

43

146,110

42

150,383

46

Genetically altered without a harmful phenotype

126,664

50

177,030

51

138,526

43

Genetically altered with a harmful phenotype

18,270

7

22,293

6

36,929

11

Totally

254,789

100

345,433

100

325,838

100

Regulatory use and routine production

2015

2016

2017

Number of

%

Number of

%

Number of

%

Quality control (incl batch safety and potency testing)

0

0

1,048

40

773

32

Other efficacy and tolerance testing

144

7

120

5

235

10

Toxicity and other safety testing including pharmacology

2,044

93

1,426

55

1,416

58

Routine production

0

0

5

<1

0

0

Totally

2,188

100

2,599

100

2,424

100

Re-use

2015

2016

2017

Number of

%

Number of

%

Number of

%

No

235,961

93

339,299

98

319,236

98

Yes

18,828

7

6,134

2

6,602

2

Totally

254,789

100

345,433

100

325,838

100



Basic research

(first use and re-use)

2015

2016

2017

Number of

%

Number of

%

Number of

%

Oncology

13,825

7

28,930

10

22,557

   10

Cardiovascular Blood and Lymphatic System

28,833

14

39,229

14

44,731

19

Nervous System

44,616

22

51,837

18

53,838

23

Respiratory System

1,652

1

2,732

1

7,362

3

Gastrointestinal System including Liver

3,971

2

6,256

2

1,531

1

Musculoskeletal System

4,597

2

7,120

3

4,220

2

Immune System

29,358

15

42,537

15

23,611

10

Urogenital/Reproductive System

2,892

1

2,658

1

6,543

3

Sensory Organs (skin, eyes and ears)

3,495

2

4,523

2

3,150

1

Endocrine System/Metabolism

18,578

9

25,651

9

28,055

12

Multisystemic

18,073

9

31,111

11

10,201

4

Ethology / Animal Behaviour /Animal Biology

19,510

10

16,487

6

16,914

7

Other basic research

13,050

6

24,836

9

10,528

5

Totally

202,450

100

283,907

100

233,241

100

Translational and applied research (first use and re-use)

2015

2016

2017

Number of

%

Number of

%

Number of

%

Human Cancer

11,929

30

14,014

28

10,841

19

Human Infectious Disorders

883

2

973

2

1,328

2

Human Cardiovascular Disorders

7,234

18

5,606

11

6,483

12

Human Nervous and Mental Disorders

2,777

7

4,523

9

9,737

17

Human Respiratory Disorders

6,436

16

5,806

11

5,077

9

Human Gastrointestinal Disorders including Liver

386

1

279

1

0

0

Human Musculoskeletal Disorders

263

1

246

<1

862

2

Human Immune Disorders

2,053

5

1,441

3

9,271

17

Human Urogenital/Reproductive Disorders

117

<1

75

<1

255

<1

Human Sensory Organ Disorders (skin, eyes and ears)

109

<1

292

1

500

1

Human Endocrine/Metabolism Disorders

2,914

7

3,288

7

5,687

10

Other Human Disorders

1,636

4

3,802

8

2,323

4

Animal Diseases and Disorders

728

2

1,160

2

704

1

Animal Welfare

18

<1

6,578

13

105

<1

Diagnosis of diseases

239

1

530

1

542

1

Plant diseases

0 

0

0

0

0

0

Non-regulatory toxicology and ecotoxicology

2,163

5

1,955

4

1,998

4

Totally

39,885

100

50,568

100

55,713

100

Sweden: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

220281

67.83%

Rats

19321

5.95%

Guinea-Pigs

409

0.13%

Hamsters (Syrian)

34

0.01%

Hamsters (Chinese)

Mongolian gerbil

Other Rodents

5

0%

Rabbits

1574

0.48%

Cats

104

0.03%

Dogs

386

0.12%

Ferrets

Other carnivores

140

0.04%

Horses, donkeys and cross-breeds

41

0.01%

Pigs

1557

0.48%

Goats

30

0.01%

Sheep

35

0.01%

Cattle

1420

0.44%

Prosimians

Marmoset and tamarins

Cynomolgus monkey

2

0%

Rhesus monkey

23

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

327

0.1%

Domestic fowl

1452

0.45%

Other birds

11269

3.47%

Reptiles

Rana

308

0.09%

Xenopus

261

0.08%

Other Amphibians

2694

0.83%

Zebra fish

29158

8.98%

Other Fish

33940

10.45%

Cephalopods

Total

324771

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

249147

78.31%

Animals born in the EU but not at a registered breeder

64675

20.33%

Animals born in rest of Europe

1608

0.51%

Animals born in rest of world

2714

0.85%

Total

318144

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

6

24%

Animals born in America

19

76%

Animals born in Africa

Animals born elsewhere

Total

25

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

25

100%

Self-sustaining colony

Total

25

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

232174

71.49%

Translational and applied research

55713

17.15%

Regulatory use and Routine production

2424

0.75%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

27916

8.6%

Preservation of species

617

0.19%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

4248

1.31%

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

1679

0.52%

Total

324771

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

22549

9.71%

Cardiovascular Blood and Lymphatic System

44502

19.17%

Nervous System

53425

23.01%

Respiratory System

7362

3.17%

Gastrointestinal System including Liver

1531

0.66%

Musculoskeletal System

4220

1.82%

Immune System

23194

9.99%

Urogenital/Reproductive System

6543

2.82%

Sensory Organs (skin, eyes and ears)

3150

1.36%

Endocrine System/Metabolism

28055

12.08%

Multisystemic

10201

4.39%

Ethology / Animal Behaviour /Animal Biology

16914

7.29%

Other basic research

10528

4.53%

Total

232174

100.00%



Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

10841

19.46%

Human Infectious Disorders

1328

2.38%

Human Cardiovascular Disorders

6483

11.64%

Human Nervous and Mental Disorders

9737

17.48%

Human Respiratory Disorders

5077

9.11%

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

862

1.55%

Human Immune Disorders

9271

16.64%

Human Urogenital/Reproductive Disorders

255

0.46%

Human Sensory Organ Disorders (skin, eyes and ears)

500

0.9%

Human Endocrine/Metabolism Disorders

5687

10.21%

Other Human Disorders

2323

4.17%

Animal Diseases and Disorders

704

1.26%

Animal Welfare

105

0.19%

Diagnosis of diseases

542

0.97%

Plant diseases

Non-regulatory toxicology and ecotoxicology

1998

3.59%

Total

55713

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

773

31.89%

Other efficacy and tolerance testing

235

9.69%

Toxicity and other safety testing including pharmacology

1416

58.42%

Routine production

Total

2424

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

Other quality controls

Pyrogenicity testing

Batch potency testing

773

100%

Total

773

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

Carcinogenicity

Developmental toxicity

Ecotoxicity

Eye irritation/corrosion

Genotoxicity

Neurotoxicity

Other toxicity/safety testing

Pharmaco-dynamics (incl safety pharmacology)

Phototoxicity

Reproductive toxicity

Safety testing in food and feed area

Skin irritation/corrosion

Skin sensitisation

Target animal safety

Repeated dose toxicity

113

7.98%

Kinetics

1303

92.02%

Total

1416

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

Other lethal methods

Non lethal methods

Total

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

113

100%

29 - 90 days

> 90 days

Total

113

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

Chronic toxicity

Reproductive ecotoxicity

Endocrine activity

Bioaccumulation

Other ecotoxicity

Total

Routine production

Routine production

Number of uses

Percentage

Blood based products

Monoclonal antibody by mouse ascites method

Other product types

Total

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1651

68.11%

Legislation on medicinal products for veterinary use and their residues

773

31.89%

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other legislation

Total

2424

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2424

100%

Legislation satisfying national requirements only [within EU]

Legislation satisfying Non-EU requirements only

Total

2424

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

318169

97.97%

Yes

6602

2.03%

Total

324771

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

9324

2.87%

Mild [up to and including]

109850

33.82%

Moderate

164539

50.66%

Severe

41058

12.64%

Total

324771

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

291525

89.76%

Yes

33246

10.24%

Total

324771

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

149970

46.18%

Genetically altered without a harmful phenotype

137872

42.45%

Genetically altered with a harmful phenotype

36929

11.37%

Total

324771

100.00%



United Kingdom

United Kingdom: Narrative 2015

Please note that the submitted data combines data from the separate Great Britain and Northern Ireland collections. The Home Office published 2015 data for Great Britain on the 20 July 2016 and the statistical release can be accessed online here:



https://www.gov.uk/government/statistics/statistics-of-scientific-procedures-on-living-animals-great-britain-2015 .

The Northern Ireland Department for Health data is available here:

  https://www.health-ni.gov.uk/publications/statistics-scientific-procedures-living-animals-northern-ireland .

The information submitted to the EU differs from the information published by the Home Office and what will be published by the Department for Health. The key difference is that the UK releases include procedures assessed as having sub-threshold severity for the purpose of procedure ‘[PG43] Maintenance of colonies of established genetically altered animals, not used in other procedures’ whereas this information is not provided to the EU. The UK releases additionally include, for all other purposes of procedure, procedures assessed as having sub-threshold or mild severity but such procedures are submitted to the EU in the “Mild [up to and including]” category. Additional breakdowns are also collected for the source of animals (distinguishing between animals born in the UK and animals born in the rest of the EU), as are further species breakdowns for some animals (birds, dogs). These breakdowns are aggregated to form the EU categories prior to submission to the EU.


Comparison between the 2015 and 2014 data should be exercised with caution due to some under-reporting and misclassification in 2014. See introductory section, data quality section (page 7) of ‘Annual Statistics of Scientific Procedures on Living Animals Great Britain 2015’ for further information. The report can be accessed online at:

  https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/537708/scientific-procedures-living-animals-2015.pdf .



1. General information on any changes in trends observed since the previous reporting period.


In 2015, a total of 3.17 million procedures were completed. This represents an increase of 3% (92 thousand) compared with the 3.08 million procedures completed in 2014.


Of the 3.17 million procedures, 2.10 million (66%) were experimental procedures and 1.07 million (34%) related to the creation/breeding of genetically altered animals that were not used in further procedures. Since 2014, experimental procedures have increased by 8% (155 thousand) and creation/breeding procedures have decreased by 6% (63 thousand).


There were 3.10 million animals used for the first time in completed procedures in 2015, representing an increase of 3% (89 thousand) compared with 2014.




2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.


Of the 2.10 million experimental procedures completed in 2015, the majority involved the use of mice (61%), fish (14%), and rats (12%). Comparing with 2014, there were notable changes 2 to the number of procedures involving:

·mice, which increased by 107 thousand (9%) to 1.28 million procedures in 2015;

·fish 3 , which increased by 29 thousand (11%) to 294 thousand procedures in 2015;

·rats, which increased by 24 thousand (10%) to 258 thousand procedures in 2015;

·pigs, which increased by 1,900 (45%) to 6,100 procedures in 2015;

·hamsters 4 , which decreased by 1,300 (-46%) to 1,500 procedures in 2015;

·goats, which decreased by 240 (-69%) to 110 procedures in 2015.


Of the 1.07 million procedures in 2015 related to the creation/breeding of genetically altered animals not used in further procedures, the majority involved mice (87%), fish (12%), and amphibians (0.7%). Comparing with 2014, there were notable changes 5 to the number of procedures involving:

·fish 6 , which increased by 47 thousand (61%) to 124 thousand procedures in 2015;

·amphibians 7 , which increased by 6,000 thousand (414%) to 7,400 procedures in 2015;

·mice, which decreased by 105 thousand (-10%) to 932 thousand procedures in 2015;

·rats, which decreased by 11 thousand (-60%) to 6,900 procedures in 2015;

·sheep, which decreased by 80 (-71%) to 30 procedures in 2015.


3. Information on any changes in trends in actual severities and analysis of the reasons thereof.


Of the 2.10 million experimental procedures completed in 2015:

·6% (123 thousand) were assessed as non-recovery (compared with 7% in 2014);

·64% (1.34 million) were assessed as (up to and including) mild (compared with 60% in 2014);

·24% (509 thousand) were assessed as moderate (compared with 25% in 2014);

·6% (124 thousand) were assessed as severe (compared with 8% in 2014).


Of the 1.07 million procedures in 2015 related to the creation/breeding of genetically altered animals not used in further procedures:

·0.2% (2,100) were assessed as non-recovery (compared with 0.2% in 2014);

·88% (940 thousand) were assessed as (up to and including) mild (compared with 90% in 2014);

·6% (67 thousand) were assessed as moderate (compared with 7% in 2014);

·6% (62 thousand) were assessed as severe (compared with 3% in 2014).


The changes in severity from 2014 to 2015 are compared as proportions only due to the suspected under-reporting of procedures that occurred in 2014. Changes in the proportions of severity assessments reported may be an effect of increased familiarity with the reporting procedure, rather than a true change in the severity of procedures. Given that severity information has only been collected since 2014, clear trends in this data will take several years to emerge.

In relation to the creation/breeding of genetically altered animals not used in further procedures, the main reason for severe assessments is that animals in breeding colonies were found dead with no clear explanation for the cause of death. Further guidance is required in this area, particularly with respect to fish.

Because the UK has in the past regulated the breeding of genetically altered (GA) animals (regardless of phenotype), in contrast to most other member states, there remain a large number of animals bred on mild severity protocols which were assessed as having mild actual severity. Some of these reflect invasive genotyping methods, and this is particularly common for fish. The Home Office believes however that there remains some over reporting of the actual severity of GA animals and work is ongoing to improve guidance for users on this matter.


4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The UK has subscribed to the three principles of replacement, reduction and refinement (the 3Rs) for a number of years but recent years has seen the principles of the 3Rs placed more firmly at the core of animal scientific research through the project licence evaluation process, advice given by the Inspectorate of the Animals in Science Regulation Unit and through the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). This commitment is not focused on baseline numbers, which would be evident through the statistics, and which are influenced by a range of extraneous factors. Instead, it encompasses replacement, reduction and refinement more broadly, putting them at the heart of a science-led approach.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Basic research “other category” included:

·Embryology and molecular biology;

·Parasitology;

·Some probable erroneous entries caused by confusion, e.g. research on renal system which could have been returned under urogenital/reproduction. The Home Office intends to clarify the instructions to data suppliers in the UK to improve data quality in the future;

·Studies of infectious agents where it was the agent, rather than the disease, under investigation.


Applied research “other” category included:

·Pharmacokinetic and/or Pharmacodynamic (PK/PD) studies;

·Mitochondrial disease;

·Haematology.


Regulatory use, routine production “other”:

·Antigens, infectious agents including parasites, oocytes, etc;

·Antibodies (but not by ascites method);

·Urine.


Regulatory use, quality control “other”:

·Method development, agent standardisation;

·Vaccine stability and testing of seed materials.


Regulatory use, legislative purpose “other”:

·Most commonly to meet industry required standards, rather than legislative requirements.


Regulatory use, ecotoxicity “other”:

·Effects on non-target (i.e. ASPA non-Schedule 2) species


6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.


Not applicable.

United Kingdom: Statistical Data 2015

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

2208377

69.7%

Rats

264697

8.35%

Guinea-Pigs

21831

0.69%

Hamsters (Syrian)

1500

0.05%

Hamsters (Chinese)

Mongolian gerbil

278

0.01%

Other Rodents

1763

0.06%

Rabbits

14224

0.45%

Cats

322

0.01%

Dogs

4753

0.15%

Ferrets

626

0.02%

Other carnivores

496

0.02%

Horses, donkeys and cross-breeds

8356

0.26%

Pigs

6350

0.2%

Goats

105

0%

Sheep

47237

1.49%

Cattle

4629

0.15%

Prosimians

Marmoset and tamarins

131

0%

Cynomolgus monkey

3333

0.11%

Rhesus monkey

148

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

720

0.02%

Domestic fowl

128718

4.06%

Other birds

14061

0.44%

Reptiles

Rana

378

0.01%

Xenopus

15577

0.49%

Other Amphibians

1840

0.06%

Zebra fish

271773

8.58%

Other Fish

146257

4.62%

Cephalopods

Total

3168480

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2830494

91.43%

Animals born in the EU but not at a registered breeder

239430

7.73%

Animals born in rest of Europe

8705

0.28%

Animals born in rest of world

17316

0.56%

Total

3095945

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

221

9.89%

Animals born in rest of Europe

Animals born in Asia

596

26.68%

Animals born in America

Animals born in Africa

1417

63.43%

Animals born elsewhere

Total

2234

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

598

26.77%

Self-sustaining colony

1636

73.23%

Total

2234

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1408901

44.47%

Translational and applied research

417992

13.19%

Regulatory use and Routine production

556113

17.55%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

18200

0.57%

Preservation of species

757

0.02%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1845

0.06%

Forensic enquiries

121

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

764551

24.13%

Total

3168480

100.00%



Basic Research

Basic Research

Number of uses

Percentage

Oncology

161953

11.49%

Cardiovascular Blood and Lymphatic System

95627

6.79%

Nervous System

256944

18.24%

Respiratory System

30767

2.18%

Gastrointestinal System including Liver

27312

1.94%

Musculoskeletal System

31016

2.2%

Immune System

247072

17.54%

Urogenital/Reproductive System

50092

3.56%

Sensory Organs (skin, eyes and ears)

29681

2.11%

Endocrine System/Metabolism

34373

2.44%

Multisystemic

274443

19.48%

Ethology / Animal Behaviour /Animal Biology

90950

6.46%

Other basic research

78671

5.58%

Total

1408901

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

84909

20.31%

Human Infectious Disorders

62048

14.84%

Human Cardiovascular Disorders

8285

1.98%

Human Nervous and Mental Disorders

55650

13.31%

Human Respiratory Disorders

9648

2.31%

Human Gastrointestinal Disorders including Liver

6115

1.46%

Human Musculoskeletal Disorders

2637

0.63%

Human Immune Disorders

19467

4.66%

Human Urogenital/Reproductive Disorders

3666

0.88%

Human Sensory Organ Disorders (skin, eyes and ears)

11059

2.65%

Human Endocrine/Metabolism Disorders

5416

1.3%

Other Human Disorders

84111

20.12%

Animal Diseases and Disorders

28285

6.77%

Animal Welfare

5283

1.26%

Diagnosis of diseases

3182

0.76%

Plant diseases

9

0%

Non-regulatory toxicology and ecotoxicology

28222

6.75%

Total

417992

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

185742

33.4%

Other efficacy and tolerance testing

18374

3.3%

Toxicity and other safety testing including pharmacology

211600

38.05%

Routine production

140397

25.25%

Total

556113

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

16803

9.05%

Pyrogenicity testing

2609

1.4%

Batch potency testing

154450

83.15%

Other quality controls

11880

6.4%

Total

185742

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

16115

7.62%

Skin irritation/corrosion

340

0.16%

Skin sensitisation

5304

2.51%

Eye irritation/corrosion

173

0.08%

Repeated dose toxicity

44153

20.87%

Carcinogenicity

15365

7.26%

Genotoxicity

5335

2.52%

Reproductive toxicity

26842

12.69%

Developmental toxicity

64814

30.63%

Neurotoxicity

395

0.19%

Kinetics

4792

2.26%

Pharmaco-dynamics (incl safety pharmacology)

4240

2%

Phototoxicity

Ecotoxicity

12433

5.88%

Safety testing in food and feed area

681

0.32%

Target animal safety

7004

3.31%

Other toxicity/safety testing

3614

1.71%

Total

211600

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

8898

55.22%

Other lethal methods

285

1.77%

Non lethal methods

6932

43.02%

Total

16115

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

24189

54.78%

29 - 90 days

12736

28.85%

> 90 days

7228

16.37%

Total

44153

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

4152

33.39%

Chronic toxicity

6816

54.82%

Reproductive ecotoxicity

Endocrine activity

932

7.5%

Bioaccumulation

265

2.13%

Other ecotoxicity

268

2.16%

Total

12433

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

48690

34.68%

Monoclonal antibody by mouse ascites method

Other product types

91707

65.32%

Total

140397

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

269750

48.51%

Legislation on medicinal products for veterinary use and their residues

128586

23.12%

Medical devices legislation

8308

1.49%

Industrial chemicals legislation

75640

13.6%

Plant protection product legislation

22056

3.97%

Biocides legislation

1550

0.28%

Food legislation including food contact material

1934

0.35%

Feed legislation including legislation for the safety of target animals, workers and environment

5971

1.07%

Cosmetics legislation

Other legislation

42318

7.61%

Total

556113

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

536912

96.55%

Legislation satisfying national requirements only [within EU]

161

0.03%

Legislation satisfying Non-EU requirements only

19040

3.42%

Total

556113

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

3098179

97.78%

Yes

70301

2.22%

Total

3168480

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

125003

3.95%

Mild [up to and including]

2281252

72%

Moderate

576163

18.18%

Severe

186062

5.87%

Total

3168480

100.00%



Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

2861245

90.3%

Yes

307235

9.7%

Total

3168480

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1485634

46.89%

Genetically altered without a harmful phenotype

1220639

38.52%

Genetically altered with a harmful phenotype

462207

14.59%

Total

3168480

100.00%



United Kingdom: Narrative 2016

Please note that the submitted data combines data from the separate Great Britain and Northern Ireland collections. The Home Office published 2016 data for Great Britain on the 13 July 2017 and the statistical release can be accessed online here:

https://www.gov.uk/government/statistics/statistics-of-scientific-procedures-on-living-animals-great-britain-2016 .

The Northern Ireland Department for Health data is available here:

  https://www.health-ni.gov.uk/publications/statistics-scientific-procedures-living-animals-northern-ireland .

The information submitted to the EU differs from the information published by the Home Office and what will be published by the NIDH. The key difference is that the UK releases include procedures assessed as having sub-threshold severity for the purpose of procedure ‘[PG43] Maintenance of colonies of established genetically altered animals, not used in other procedures’, whereas this information is neither required by nor provided to the EU. In addition, the UK data releases separate procedures assessed as being of sub-threshold or mild severity, whereas all such procedures are combined into the “Mild [up to and including]” category when the data is submitted to the EU. Likewise, additional details are also collected in the UK data for the source of animals (i.e. distinguishing between animals born in the UK and animals born in the rest of the EU), as are further species breakdowns for some animals (e.g. birds, dogs). These sub-categories of data are aggregated to form the EU categories prior to submission to the EU.



1. General information on any changes in trends observed since the previous reporting period.


In 2016, a total of 2.79 million procedures were completed. This represents a decrease of 12% (378,000) compared with the 3.17 million procedures completed in 2015.


Of the 2.79 million procedures, 2.04 million (73%) were experimental procedures and 751,000 (27%) related to the creation/breeding of genetically altered animals that were not used in further procedures. Since 2015, experimental procedures have decreased by 3% (57,000) and creation/breeding procedures have decreased by 30% (321,000). The reduction in the number of procedures recorded as being for creation and/or breeding appears to occur because licensees are more accurately recording actual severity, rather than returning procedures according to the prospective severity category. As such, in 2016, a substantially greater proportion of breeding procedures prospectively accorded mild severity were returned as sub-threshold and therefore not included in this dataset.


There were 2.72 million animals used for the first time in completed procedures in 2016, representing a decrease of 12% (378,000) compared with 2015. This difference from the previous year may be explained, at least in part, by an improvement in the accuracy of recording the procedural severity. Licensees are increasingly correctly returning the actual severity suffered by the animal rather than the prospective severity of the procedure as described in their licence, as explained above. Other reasons why the number of animals has dropped sharply may also include an actual reduction in the number in experimental animals required and the reported improved efficiencies in the creation of new strains, in particular by the use of CRISPR/Cas9 technology.


2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.


Of the 2.04 million experimental procedures completed in 2016, the majority involved the use of mice (60%), fish (14%), and rats (12%). Comparing with 2015, there were notable changes 8 to the number of procedures involving:

·mice, which decreased by 47,000 (-4%) to 1.23 million procedures in 2016;

·rats, which decreased by 19,000 (-7%) to 239,000 procedures in 2016;

·birds 9 , which increased by 8,100 (6%) to 150,000 procedures in 2016;

·guinea pigs, which increased by 4,400 (20%) to 26,000 procedures in 2016;

·ferrets, which decreased by 150 (-24%) to 480 procedures in 2016;

·goats, which increased by 110 (104%) to 210 procedures in 2016.


Of the 751,000 procedures in 2016 related to the creation/breeding of genetically altered animals not used in further procedures, the majority involved mice (83%), fish (16%), and rats (1%). Comparing with 2015, there were notable changes 10 to the number of procedures involving:

·mice, which decreased by 309,000 (-33%) to 623,000 procedures in 2016;

·amphibians 11 , which decreased by 6,200 (-83%) to 1,300 procedures in 2016;

·fish 12 , which decreased by 5,300 (-4%) to 119,000 procedures in 2016;

·birds 13 , which increased by 500 (83%) to 1,100 procedures in 2016;

·sheep, which increased by 160 (516%) to 190 procedures in 2016.

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.


Of the 2.04 million experimental procedures completed in 2016:

·8% (155,000) were assessed as non-recovery, compared with 6% (123,000) in 2015;

·58% (1.18 million) were assessed as (up to and including) mild, compared with 64% (1.34 million) in 2015;

·29% (589,000) were assessed as moderate, compared with 24% (509,000) in 2015;

·6% (115,000) were assessed as severe, compared with 6% (124,000) in 2015.


Of the 751,000 procedures in 2016 related to the creation/breeding of genetically altered animals not used in further procedures:

·0.2% (1,500) were assessed as non-recovery, compared with 0.2% (2,100) in 2015;

·88% (659,000) were assessed as (up to and including) mild, compared with 88% (940,000) in 2015;

·7% (51,000) were assessed as moderate, compared with 6% (67,000) in 2015;

·5% (40,000) were assessed as severe, compared with 6% (62,000) in 2015).


Changes in the proportions of severity assessments reported may be an effect of increased familiarity with the reporting procedure, rather than a true change in the severity of procedures. Given that severity information has only been collected since 2014, clear trends in this data will take several years to emerge.

In relation to the creation/breeding of genetically altered animals not used in further procedures, the main reason for severe assessments is that animals in breeding colonies were found dead with no clear explanation for the cause of death; the default position being that where the death cannot be excluded from being procedural, it is recorded as ‘severe’. Home Office continues to look to improve the guidance provided in this area, particularly with respect to fish.

Because the UK has in the past regulated the breeding of genetically altered (GA) animals (regardless of phenotype), in contrast to most other Member States, there remain a large number of animals bred on mild severity protocols which were assessed as having mild actual severity. Some of these reflect invasive genotyping methods, and this is particularly common for fish. The Home Office believes however that there remains some over reporting of the actual severity of GA animals. Nevertheless, the reduction in the overall numbers of procedures by severity for creation and breeding of animals for use in 2016 suggests that the ongoing education and improved guidance for users on this matter is having an impact.


4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The UK has subscribed to the three principles of replacement, reduction and refinement (the 3Rs) for a number of years but recent years has seen the principles of the 3Rs placed more firmly at the core of animal scientific research. This is principally achieved through the project licence evaluation process, provision of advice by the Inspectorate of the Animals in Science Regulation Unit and through the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). This commitment is not focused on baseline numbers, which would be evident through the statistics, and which are influenced by a range of extraneous factors. Instead, it encompasses replacement, reduction and refinement more broadly, putting them at the heart of a science-led approach.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Basic research “other category” included:

·Embryology and molecular biology;

·Parasitology;

·Studies of infectious agents where it was the agent, rather than the disease, under investigation.

·Some probable erroneous entries caused by confusion. The Home Office intends to clarify the instructions to data suppliers in the UK to improve data quality in the future;

Applied research “other” category included:

·Pharmacokinetic and/or Pharmacodynamic (PK/PD) studies;

·Mitochondrial diseases;

·Haematology.

Regulatory use, routine production “other”:

·Antigens, infectious agents including parasites, oocytes, etc;

·Antibodies (but not by ascites method);

·Urine.

Regulatory use, quality control “other”:

·Method development, agent standardisation;

·Vaccine stability and testing of seed materials.

Regulatory use, legislative purpose “other”:

·Most commonly to meet industry required standards, rather than legislative requirements.

Regulatory use, ecotoxicity “other”:

·Effects on non-target (i.e. ASPA non-Schedule 2) species


6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.


Not applicable.

United Kingdom: Statistical Data 2016

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1852305

66.38%

Rats

244904

8.78%

Guinea-Pigs

26192

0.94%

Hamsters (Syrian)

1239

0.04%

Hamsters (Chinese)

230

0.01%

Mongolian gerbil

236

0.01%

Other Rodents

1521

0.05%

Rabbits

15568

0.56%

Cats

345

0.01%

Dogs

5005

0.18%

Ferrets

476

0.02%

Other carnivores

236

0.01%

Horses, donkeys and cross-breeds

8948

0.32%

Pigs

6361

0.23%

Goats

214

0.01%

Sheep

48596

1.74%

Cattle

4996

0.18%

Prosimians

Marmoset and tamarins

197

0.01%

Cynomolgus monkey

3240

0.12%

Rhesus monkey

132

0%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

860

0.03%

Domestic fowl

139789

5.01%

Other birds

11543

0.41%

Reptiles

Rana

225

0.01%

Xenopus

10123

0.36%

Other Amphibians

893

0.03%

Zebra fish

308108

11.04%

Other Fish

97910

3.51%

Cephalopods

Total

2790392

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2593408

95.42%

Animals born in the EU but not at a registered breeder

108530

3.99%

Animals born in rest of Europe

4803

0.18%

Animals born in rest of world

11057

0.41%

Total

2717798

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

263

10.78%

Animals born in rest of Europe

Animals born in Asia

652

26.72%

Animals born in America

Animals born in Africa

1525

62.5%

Animals born elsewhere

Total

2440

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

F2 or greater

701

28.73%

Self-sustaining colony

1739

71.27%

Total

2440

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1350177

48.39%

Translational and applied research

354145

12.69%

Regulatory use and Routine production

539454

19.33%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

18800

0.67%

Preservation of species

1789

0.06%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1675

0.06%

Forensic enquiries

92

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

524260

18.79%

Total

2790392

100.00%


Basic Research

Basic Research

Number of uses

Percentage

Oncology

173650

12.86%

Cardiovascular Blood and Lymphatic System

89072

6.6%

Nervous System

271513

20.11%

Respiratory System

16937

1.25%

Gastrointestinal System including Liver

28417

2.1%

Musculoskeletal System

23767

1.76%

Immune System

243534

18.04%

Urogenital/Reproductive System

41652

3.08%

Sensory Organs (skin, eyes and ears)

31810

2.36%

Endocrine System/Metabolism

32237

2.39%

Multisystemic

181829

13.47%

Ethology / Animal Behaviour /Animal Biology

55479

4.11%

Other basic research

160280

11.87%

Total

1350177

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

86416

24.4%

Human Infectious Disorders

86702

24.48%

Human Cardiovascular Disorders

6491

1.83%

Human Nervous and Mental Disorders

37303

10.53%

Human Respiratory Disorders

15171

4.28%

Human Gastrointestinal Disorders including Liver

6347

1.79%

Human Musculoskeletal Disorders

5447

1.54%

Human Immune Disorders

10463

2.95%

Human Urogenital/Reproductive Disorders

2464

0.7%

Human Sensory Organ Disorders (skin, eyes and ears)

9052

2.56%

Human Endocrine/Metabolism Disorders

6651

1.88%

Other Human Disorders

8292

2.34%

Animal Diseases and Disorders

29218

8.25%

Animal Welfare

2908

0.82%

Diagnosis of diseases

1434

0.4%

Plant diseases

Non-regulatory toxicology and ecotoxicology

39786

11.23%

Total

354145

100.00%

Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

181199

33.59%

Other efficacy and tolerance testing

26707

4.95%

Toxicity and other safety testing including pharmacology

189460

35.12%

Routine production

142088

26.34%

Total

539454

100.00%



Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

7239

4%

Pyrogenicity testing

2472

1.36%

Batch potency testing

145190

80.13%

Other quality controls

26298

14.51%

Total

181199

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

18993

10.02%

Skin irritation/corrosion

266

0.14%

Skin sensitisation

4586

2.42%

Eye irritation/corrosion

128

0.07%

Repeated dose toxicity

43054

22.72%

Carcinogenicity

3742

1.98%

Genotoxicity

3746

1.98%

Reproductive toxicity

39078

20.63%

Developmental toxicity

44812

23.65%

Neurotoxicity

280

0.15%

Kinetics

4197

2.22%

Pharmaco-dynamics (incl safety pharmacology)

4472

2.36%

Phototoxicity

Ecotoxicity

15038

7.94%

Safety testing in food and feed area

346

0.18%

Target animal safety

2265

1.2%

Other toxicity/safety testing

4457

2.35%

Total

189460

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

11204

58.99%

Other lethal methods

326

1.72%

Non lethal methods

7463

39.29%

Total

18993

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

20143

46.79%

29 - 90 days

14889

34.58%

> 90 days

8022

18.63%

Total

43054

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3786

25.18%

Chronic toxicity

8066

53.64%

Reproductive ecotoxicity

2370

15.76%

Endocrine activity

389

2.59%

Bioaccumulation

427

2.84%

Other ecotoxicity

Total

15038

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

52732

37.11%

Monoclonal antibody by mouse ascites method

Other product types

89356

62.89%

Total

142088

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

250469

46.43%

Legislation on medicinal products for veterinary use and their residues

127249

23.59%

Medical devices legislation

9641

1.79%

Industrial chemicals legislation

71086

13.18%

Plant protection product legislation

17480

3.24%

Biocides legislation

3149

0.58%

Food legislation including food contact material

1904

0.35%

Feed legislation including legislation for the safety of target animals, workers and environment

12988

2.41%

Cosmetics legislation

Other legislation

45488

8.43%

Total

539454

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

517132

95.86%

Legislation satisfying national requirements only [within EU]

96

0.02%

Legislation satisfying Non-EU requirements only

22226

4.12%

Total

539454

100.00%

First uses and re-uses

Re-use

Number of uses

Percentage

No

2720238

97.49%

Yes

70154

2.51%

Total

2790392

100.00%



Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

156086

5.59%

Mild [up to and including]

1839922

65.94%

Moderate

640064

22.94%

Severe

154320

5.53%

Total

2790392

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

2564079

91.89%

Yes

226313

8.11%

Total

2790392

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1380447

49.47%

Genetically altered without a harmful phenotype

1041325

37.32%

Genetically altered with a harmful phenotype

368620

13.21%

Total

2790392

100.00%



United Kingdom: Narrative 2017

Please note that the submitted data combines data from the separate Great Britain and Northern Ireland collections. The Home Office published 2017 data for Great Britain on the 19 July 2018 and the statistical release can be accessed online here:

https://www.gov.uk/government/statistics/statistics-of-scientific-procedures-on-living-animals-great-britain-2017 .

The Northern Ireland Department for Health (NIDH) published their 2017 data here:

  https://www.health-ni.gov.uk/publications/statistics-scientific-procedures-living-animals-northern-ireland .

The information submitted to the EU differs from the information published by the Home Office and what will be published by the NIDH. The key difference is that the UK releases include procedures assessed as having sub-threshold severity for the purpose of procedure ‘[PG43] Maintenance of colonies of established genetically altered animals, not used in other procedures’, whereas this information is neither required by nor provided to the EU. In addition, the UK data releases separate procedures assessed as being of sub-threshold from those of mild severity, whereas all such procedures (i.e. all procedures other than PG43) are combined into the “Mild [up to and including]” category when the data is submitted to the EU. Likewise, additional details are also collected in the UK data for the source of animals (i.e. distinguishing between animals born in the UK and animals born in the rest of the EU), as are further species breakdowns for some animals (e.g. birds, dogs). These sub-categories of data are aggregated to form the EU categories prior to submission to the EU.

1. General information on any changes in trends observed since the previous reporting period.

In 2017, a total of 2.57 million procedures were completed. This represents a decrease of 8% (216,000) compared with the 2.79 million procedures completed in 2016.


Of the 2.57 million procedures, 1.91 million (74%) were experimental procedures and 669,000 (26%) related to the creation/breeding of genetically altered animals that were not used in further procedures. Since 2016, experimental procedures have decreased by 7% (134,000) and creation/breeding procedures have decreased by 11% (82,000). The reduction in the number of procedures recorded as being for creation and/or breeding appears to be due largely for two reasons: i) a decrease in the number of zebra fish bred but not used compared to 2016 and ii) more accurate recording of actual severity (a greater proportion of animals reported to be subthreshold instead of mild and hence omitted from the UK return).


There were 2.51 million animals used for the first time in completed procedures in 2017, representing a decrease of 8% (214,000) compared with 2016. The reason for this is not clear but appears to reflect a reduction in research activity across several sectors and is not confined to any particular purpose.

2. Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Of the 1.91 million experimental procedures completed in 2017, the majority involved the use of mice (58%), fish (16%) and rats (12%). Comparing with 2016, there were notable changes 14 to the number of procedures involving:

·mice, which decreased by 124,000 (-10%) to 1.10 million procedures in 2017;

·birds 15 , which decreased by 19,000 (-13%) to 131,000 procedures in 2017;

·Rana, which decreased by 120 (-52%) to 110 procedures in 2017.

·other rodents, which increased by 810 (+53%) to 2,300 procedures in 2017;

·cattle, which increased by 4,100 (+82%) to 9,100 procedures in 2017;

·fish 16 , which increased by 22,000(+8%) to 309,000 procedures in 2017;


Of the 669,000 procedures in 2017 related to the creation/breeding of genetically altered animals not used in further procedures, the majority involved mice (84%), fish (15%), and rats (0.5%). Comparing with 2016, there were notable changes 17 to the number of procedures involving:

·mice, which decreased by 63,000 (-10%) to 560,000 procedures in 2017;

·fish 18 , which decreased by 16,000 (-13%) to 104,000 procedures in 2017;

·rats, which decreased by 2,400 (-45%) to 3,100 procedures in 2017;

·sheep, which decreased by 170 (-91%) to 20 procedures in 2017;

·pigs, which decreased by 120 (-49%) to 120 procedures in 2017;

·amphibians 19 , which decreased by 620 (-49%) to 640 procedures in 2017;

3. Information on any changes in trends in actual severities and analysis of the reasons thereof.

Of the 1.91 million experimental procedures completed in 2017:

·7% (135,000) were assessed as non-recovery, compared with 8% (155,000) in 2016;

·61% (1.17 million) were assessed as (up to and including) mild, compared with 58% (1.18 million) in 2016;

·26% (504,000) were assessed as moderate, compared with 29% (589,000) in 2016;

·5% (95,000) were assessed as severe, compared with 6% (115,000) in 2016.


Of the 669,000 procedures in 2017 related to the creation/breeding of genetically altered animals not used in further procedures:

·0.07% (470) were assessed as non-recovery, compared with 0.2% (1,500) in 2016;

·85% (570,000) were assessed as (up to and including) mild, compared with 88% (658,000) in 2016;

·8% (55,000) were assessed as moderate, compared with 7% (51,000) in 2016;

·6% (43,000) were assessed as severe, compared with 5% (40,000) in 2016.


Changes in the proportions of severity assessments reported may be an effect of increased familiarity with the reporting procedure, rather than a true change in the severity of procedures. Given that severity information has only been collected since 2014, clear trends in this data will take several years to emerge.

In relation to the creation/breeding of genetically altered animals not used in further procedures, the main reason for severe assessments is that animals in breeding colonies were found dead with no clear explanation for the cause of death; the default position being that where the death cannot be excluded from being procedural, it is recorded as ‘severe’. Home Office continues to look to improve the guidance provided in this area, particularly with respect to fish.

Because the UK has in the past regulated the breeding of genetically altered (GA) animals (regardless of phenotype), in contrast to most other Member States, there remain a large number of animals bred on mild severity protocols which were assessed as having mild actual severity. Some of these reflect invasive genotyping methods, and this is particularly common for fish. The Home Office believes however that there remains some over reporting of the actual severity of GA animals. Nevertheless, the reduction in the overall numbers of procedures by severity for creation and breeding of animals for use in 2017 suggests that the ongoing education and improved guidance for users on this matter is having an impact.

4. Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

The UK has subscribed to the three principles of replacement, reduction and refinement (the 3Rs) for a number of years but recent years has seen the principles of the 3Rs placed more firmly at the core of animal scientific research. This is principally achieved through the project licence evaluation process, provision of advice by the Inspectorate of the Animals in Science Regulation Unit and through the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). This commitment is not focused on baseline numbers, which would be evident through the statistics, and which are influenced by a range of extraneous factors. Instead, it encompasses replacement, reduction and refinement more broadly, putting them at the heart of a science-led approach.

5. Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Basic research “other category” included:

·Embryology, cell and molecular biology;

·Genetics;

·Parasitology;

·Studies of infectious agents where it was the agent, rather than the disease, under investigation;

·Some probable erroneous entries eg. renal disease, caused by confusion as to which category to use. The Home Office intends to clarify the instructions to data suppliers in the UK to improve data quality in the future.

Applied research “other” category included:

·Pharmacokinetic and/or Pharmacodynamic (PK/PD) studies;

·Mitochondrial diseases;

·Haematology;

·Wound healing;

·Pain disorders;

·Sleep.

Regulatory use, routine production “other”:

·Antigens, infectious agents including parasites, oocytes, etc;

·Antibodies (but not by ascites method);

·Urine.

Regulatory use, quality control “other”:

·Method development, agent standardisation;

·Vaccine stability and testing of seed materials.

·Rodenticide evaluation (not field trials).

Regulatory use, legislative purpose “other”:

·Most commonly to meet industry required standards, rather than legislative requirements.

Regulatory use, toxicity “other”:

·Effects on non-target (i.e. ASPA non-Schedule 2) species;

·Metabolism.

Regulatory Use: Other legislative requirements

·Mainly production to meet industry specifications.

6. Details on cases where the 'severe' classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why 'severe' classification was exceeded.

Not applicable.

United Kingdom: Statistical Data 2017

All uses of animals by species

Animal Species

Number of animals

Percentage

Mice

1665386

64.68%

Rats

237831

9.24%

Guinea-Pigs

22560

0.88%

Hamsters (Syrian)

1126

0.04%

Hamsters (Chinese)

Mongolian gerbil

311

0.01%

Other Rodents

2327

0.09%

Rabbits

10444

0.41%

Cats

288

0.01%

Dogs

3949

0.15%

Ferrets

405

0.02%

Other carnivores

244

0.01%

Horses, donkeys and cross-breeds

10600

0.41%

Pigs

4742

0.18%

Goats

304

0.01%

Sheep

47946

1.86%

Cattle

9085

0.35%

Prosimians

Marmoset and tamarins

166

0.01%

Cynomolgus monkey

2662

0.1%

Rhesus monkey

132

0.01%

Vervets (Chlorocebus spp.)

Baboons

Squirrel monkey

Other species of non-human primates

Other species of Old World Monkeys (Cercopithecoidea)

Other species of New World Monkeys (Ceboidea)

Apes

Other Mammals

804

0.03%

Domestic fowl

125670

4.88%

Other birds

6729

0.26%

Reptiles

92

0%

Rana

108

0%

Xenopus

8095

0.31%

Other Amphibians

533

0.02%

Zebra fish

320146

12.43%

Other Fish

92190

3.58%

Cephalopods

Total

2574875

100.00%

Place of birth of animals other than non-human primates as registered at first use

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2377256

94.92%

Animals born in the EU but not at a registered breeder

112655

4.5%

Animals born in rest of Europe

3240

0.13%

Animals born in rest of world

11315

0.45%

Total

2504466

100.00%

Source of non-human primates as registered at first use

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

253

11.42%

Animals born in rest of Europe

Animals born in Asia

616

27.81%

Animals born in America

Animals born in Africa

1346

60.77%

Animals born elsewhere

Total

2215

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F0

F1

1

0.05%

F2 or greater

587

26.5%

Self-sustaining colony

1627

73.45%

Total

2215

100.00%

Purposes for which animals are used

Purpose Category

Number of uses

Percentage

Basic Research

1314541

51.05%

Translational and applied research

335968

13.05%

Regulatory use and Routine production

505504

19.63%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

11901

0.46%

Preservation of species

1925

0.07%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1235

0.05%

Forensic enquiries

88

0%

Maintenance of colonies of established genetically altered animals, not used in other procedures

403713

15.68%

Total

2574875

100.00%

Basic Research

Basic Research

Number of uses

Percentage

Oncology

176024

13.39%

Cardiovascular Blood and Lymphatic System

78397

5.96%

Nervous System

273172

20.78%

Respiratory System

11654

0.89%

Gastrointestinal System including Liver

26197

1.99%

Musculoskeletal System

28423

2.16%

Immune System

246232

18.73%

Urogenital/Reproductive System

34838

2.65%

Sensory Organs (skin, eyes and ears)

23477

1.79%

Endocrine System/Metabolism

29411

2.24%

Multisystemic

173366

13.19%

Ethology / Animal Behaviour /Animal Biology

67223

5.11%

Other basic research

146127

11.12%

Total

1314541

100.00%

Translational and applied research

Translational and applied research

Number of uses

Percentage

Human Cancer

90879

27.05%

Human Infectious Disorders

70203

20.9%

Human Cardiovascular Disorders

4374

1.3%

Human Nervous and Mental Disorders

42354

12.61%

Human Respiratory Disorders

12633

3.76%

Human Gastrointestinal Disorders including Liver

3943

1.17%

Human Musculoskeletal Disorders

6113

1.82%

Human Immune Disorders

7354

2.19%

Human Urogenital/Reproductive Disorders

3541

1.05%

Human Sensory Organ Disorders (skin, eyes and ears)

10854

3.23%

Human Endocrine/Metabolism Disorders

7815

2.33%

Other Human Disorders

10850

3.23%

Animal Diseases and Disorders

23507

7%

Animal Welfare

2843

0.85%

Diagnosis of diseases

3476

1.03%

Plant diseases

Non-regulatory toxicology and ecotoxicology

35229

10.49%

Total

335968

100.00%



Regulatory use and Routine production

Regulatory use and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

145113

28.71%

Other efficacy and tolerance testing

24606

4.87%

Toxicity and other safety testing including pharmacology

196061

38.79%

Routine production

139724

27.64%

Total

505504

100.00%

Regulatory use - Quality control (including batch safety and potency testing)

Regulatory use - Quality control (incl batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

18401

12.68%

Pyrogenicity testing

1125

0.78%

Batch potency testing

114151

78.66%

Other quality controls

11436

7.88%

Total

145113

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology

Regulatory use - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

16580

8.46%

Skin irritation/corrosion

112

0.06%

Skin sensitisation

2942

1.5%

Eye irritation/corrosion

63

0.03%

Repeated dose toxicity

40429

20.62%

Carcinogenicity

8067

4.11%

Genotoxicity

5314

2.71%

Reproductive toxicity

61241

31.24%

Developmental toxicity

34779

17.74%

Neurotoxicity

314

0.16%

Kinetics

3124

1.59%

Pharmaco-dynamics (incl safety pharmacology)

5309

2.71%

Phototoxicity

Ecotoxicity

11444

5.84%

Safety testing in food and feed area

183

0.09%

Target animal safety

1360

0.69%

Other toxicity/safety testing

4800

2.45%

Total

196061

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory use - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

10622

64.07%

Other lethal methods

98

0.59%

Non lethal methods

5860

35.34%

Total

16580

100.00%



Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

21572

53.36%

29 - 90 days

11727

29.01%

> 90 days

7130

17.64%

Total

40429

100.00%

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory use - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3653

31.92%

Chronic toxicity

6320

55.23%

Reproductive ecotoxicity

514

4.49%

Endocrine activity

84

0.73%

Bioaccumulation

873

7.63%

Other ecotoxicity

Total

11444

100.00%

Routine production

Routine production

Number of uses

Percentage

Blood based products

55197

39.5%

Monoclonal antibody by mouse ascites method

Other product types

84527

60.5%

Total

139724

100.00%

Uses of animals to meet legislative requirements

Testing by Legislation

Number of uses

Percentage

Legislation on medicinal products for human use

208938

41.33%

Legislation on medicinal products for veterinary use and their residues

118458

23.43%

Medical devices legislation

7285

1.44%

Industrial chemicals legislation

86337

17.08%

Plant protection product legislation

18417

3.64%

Biocides legislation

292

0.06%

Food legislation including food contact material

1688

0.33%

Feed legislation including legislation for the safety of target animals, workers and environment

14831

2.93%

Cosmetics legislation

Other legislation

49258

9.74%

Total

505504

100.00%

Legislative requirements

Legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

478397

94.64%

Legislation satisfying national requirements only [within EU]

1670

0.33%

Legislation satisfying Non-EU requirements only

25437

5.03%

Total

505504

100.00%



First uses and re-uses

Re-use

Number of uses

Percentage

No

2506681

97.35%

Yes

68194

2.65%

Total

2574875

100.00%

Actual severity of uses

Severity

Number of uses

Percentage

Non-recovery

135780

5.27%

Mild [up to and including]

1741624

67.64%

Moderate

559401

21.73%

Severe

138070

5.36%

Total

2574875

100.00%

Use in creation of a new genetic line

Creation of new GL

Number of uses

Percentage

No

2309701

89.7%

Yes

265174

10.3%

Total

2574875

100.00%

Uses by genetic status

Genetic Status

Number of uses

Percentage

Not genetically altered

1263597

49.07%

Genetically altered without a harmful phenotype

1102809

42.83%

Genetically altered with a harmful phenotype

208469

8.1%

Total

2574875

100.00%

(1)

http://www.oecd.org/chemicalsafety/oecd-encourages-development-of-non-animal-test-methods-for-detection-of-thyroid-disruptors.htm

(2)

Covers the three largest numeric and the three largest percentage changes between 2014 and 2015.

(3)

Specifically, Zebrafish and other fish species.

(4)

Specifically, Syrian Hamsters.

(5)

Covers the three largest numeric and the three largest percentage changes between 2014 and 2015. One of the species listed has one of the three largest percentage changes and, in addition, one of the three largest numeric changes, hence there being five species listed.

(6)

Specifically, Zebrafish and other fish species.

(7)

Specifically, Xenopus (Laevis and Tropicalis).

(8)

Covers the three largest numeric and the three largest percentage changes between 2015 and 2016.

(9)

Specifically, domestic fowl and other bird species.

(10)

 Covers the three largest numeric and the three largest percentage changes between 2015 and 2016. One of the species listed has one of the three largest percentage changes and, in addition, one of the three largest numeric changes, hence there being five species listed.

(11)

Specifically, Xenopus (Laevis and Tropicalis).

(12)

Specifically, Zebrafish and other fish species.

(13)

 Specifically domestic fowl.

(14)

Covers the three largest numeric and the three largest percentage changes between 2016 and 2017.

(15)

Specifically, domestic fowl and other bird species.

(16)

 Specifically, Zebrafish and other fish species.

(17)

 Covers the three largest numeric and the three largest percentage changes between 2016 and 2017.

(18)

Specifically, Zebrafish and other fish species.

(19)

Specifically, Xenopus (Laevis and Tropicalis).

Top

Brussels, 5.2.2020

SWD(2020) 10 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017











{COM(2020) 16 final}


SECTION C: MEMBER STATE DATA BETWEEN 2015 AND 2017

V.3. Recalculated presentation of Member State data for 2017

V.3. Recalculated presentation of Member State data for 2017    

Introduction    

Member State: Austria, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Place of birth of animals other than non-human primates    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Belgium, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Bulgaria, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Croatia, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Cyprus, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Czechia, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Denmark, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Estonia, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Finland, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: France, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Germany, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Greece, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Hungary, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Ireland, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Italy, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Latvia, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Lithuania, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Luxembourg, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Malta, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Netherlands, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Poland, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Portugal, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Romania, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Slovakia, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Slovenia, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Spain, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: Sweden, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    

Member State: United Kingdom, 2017    

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes    

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes    

Part 3: Creation and maintenance of genetically altered animal lines    



V.3. Recalculated presentation of Member State data for 2017

Introduction

Member States submitted statistical data to the Commission grouped by the main categorisation of data attributes provided in the Annex II of Commission Implementing Decision 2012/707/EU (Section C, V.1.-2. of this Staff Working Document). However, the presentation of data at EU level was restructured to allow for an improved understanding of when and how animals are still used in science today: animals (and uses) in relation to research, testing, routine production and education/training separated from animals (and uses) for the creation and maintenance of genetically altered animals.

To allow for a similar presentation and correlation with the EU data for the year 2017, the Member State annual submissions for the year 2017 were recalculated.

The recalculation was made on the basis of the three Parts of this Staff Working Document:

·Numbers of animals used for purposes of research, testing, routine production and education (including training) – Part 1 (III.1)

·Details of all uses (first and any subsequent reuse) of animals for the purposes of research, testing, routine production and education (including training) - Part 2 (III.2)

·Numbers and uses of animals for the creation and maintenance of genetically altered animals in the EU – Part 3 (III.3)

The main recalculation rules are explained below. As a result, some of the numbers may differ between the original Member Submission for the year 2017 compared to the corresponding table found in the recalculated report.

-Part 1 – Numbers of animals used in research and testing

oExcludes records that were indicated as being carried out for the creation of a new genetically altered animal line;

oExcludes records for the purposes of maintenance of established genetically altered animal lines;

oExcludes reuses.

-Part 2 – All animal uses for research and testing

oExcludes records that were indicated as being carried out for the creation of a new genetically altered animal line;

oExcludes records for the purposes of maintenance of established genetically altered animal lines;

oIncludes both the first use and any subsequent reuse;

oExcludes legislative information (type and origin of legislative requirement) that is not related to regulatory use. For example, entries for the purposes of “Routine production” have been submitted with legislative information as this requirement is included in the Commission Implementing Decision 2012/707/EU. However, since the adoption of the Decision, it has become clear that this link between routine production and legislative information is an error and the erroneous legislative data have been removed from purpose category “Routine production”. This provides for a more accurate presentation of the type and origin of legislation that results in regulatory testing.

N.B. When products (produced by using of animals such as blood based products) are placed on the market, there may be requirements for testing their purity, efficacy etc. These are reported separately under regulatory use, and therefore linked correctly with the respective legislative information.

-Part 3 – Animals (numbers and uses) used for the creation and maintenance of genetically altered animal lines

oIncludes records that were indicated as being carried out for the creation of a new genetically altered animal line;

oIncludes records for the purposes of maintenance of established genetically altered animal lines – other purposes excluded unless carried out for the creation of a new genetically altered animal line;

oIncludes both first and any subsequent reuse.

To reduce the length of the document, only those lines in which data were reported are included in the tables below.



Member State: Austria, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

169345

80.19%

Rats

5309

2.51%

Guinea-Pigs

1127

0.53%

Other Rodents

998

0.47%

Rabbits

10367

4.91%

Cats

61

0.03%

Dogs

149

0.07%

Horses, donkeys and cross-breeds

349

0.17%

Pigs

2040

0.97%

Goats

20

0.01%

Sheep

139

0.07%

Cattle

904

0.43%

Other Mammals

102

0.05%

Domestic fowl

3895

1.84%

Other birds

1810

0.86%

Xenopus

941

0.45%

Other Amphibians

912

0.43%

Zebra fish

8112

3.84%

Other Fish

4596

2.18%

Total

211176

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

195266

92.47%

Animals born in the EU but not at a registered breeder

11909

5.64%

Animals born in rest of Europe

99

0.05%

Animals born in rest of world

3902

1.85%

Total

211176

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

169345

563

169908

Rats

5309

5309

Guinea-Pigs

1127

27

1154

Hamsters (Syrian)

8

8

Mongolian gerbil

41

41

Other Rodents

998

998

Rabbits

10367

21

10388

Cats

61

61

Dogs

149

54

203

Horses, donkeys and cross-breeds

349

172

521

Pigs

2040

2040

Goats

20

2

22

Sheep

139

10

149

Cattle

904

4

908

Other Mammals

102

102

Domestic fowl

3895

3895

Other birds

1810

9

1819

Xenopus

941

31

972

Other Amphibians

912

912

Zebra fish

8112

8112

Other Fish

4596

34

4630

Total

211176

976

212152

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

105109

49.54%

Translational and applied research

77138

36.36%

Regulatory use and Routine production

26569

12.52%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

198

0.09%

Preservation of species

30

0.01%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

3108

1.46%

Total

212152

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

21077

20.05%

Cardiovascular Blood and Lymphatic System

8833

8.4%

Nervous System

12522

11.91%

Respiratory System

316

0.3%

Gastrointestinal System including Liver

1997

1.9%

Musculoskeletal System

4947

4.71%

Immune System

25168

23.94%

Urogenital/Reproductive System

1128

1.07%

Sensory Organs (skin, eyes and ears)

1208

1.15%

Endocrine System/Metabolism

1304

1.24%

Multisystemic

7835

7.45%

Ethology / Animal Behaviour /Animal Biology

5799

5.52%

Other basic research

12975

12.34%

Total

105109

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

14506

18.81%

Human Infectious Disorders

42202

54.71%

Human Cardiovascular Disorders

5109

6.62%

Human Nervous and Mental Disorders

5487

7.11%

Human Respiratory Disorders

285

0.37%

Human Gastrointestinal Disorders including Liver

151

0.2%

Human Musculoskeletal Disorders

260

0.34%

Human Immune Disorders

785

1.02%

Human Urogenital/Reproductive Disorders

201

0.26%

Human Sensory Organ Disorders (skin, eyes and ears)

300

0.39%

Human Endocrine/Metabolism Disorders

1138

1.48%

Other Human Disorders

576

0.75%

Animal Diseases and Disorders

4816

6.24%

Animal Welfare

542

0.7%

Diagnosis of diseases

715

0.93%

Non-regulatory toxicology and ecotoxicology

65

0.08%

Total

77138

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

25823

97.19%

Toxicity and other safety testing including pharmacology

740

2.79%

Routine production

6

0.02%

Total

26569

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

2700

10.46%

Pyrogenicity testing

9125

35.34%

Batch potency testing

13554

52.49%

Other quality controls

444

1.72%

Total

25823

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Repeated dose toxicity

43

5.81%

Neurotoxicity

32

4.32%

Target animal safety

665

89.86%

Total

740

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

29 - 90 days

43

100%

Total

43

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

25864

97.37%

Medical devices legislation

2

0.01%

Plant protection product legislation

665

2.5%

Other legislation

32

0.12%

Total

26563

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

23031

86.7%

Legislation satisfying Non-EU requirements only

3532

13.3%

Total

26563

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

6

100%

Total

6

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

211176

99.54%

Yes

976

0.46%

Total

212152

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

5087

2.4%

Mild [up to and including]

125863

59.33%

Moderate

60095

28.33%

Severe

21107

9.95%

Total

212152

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

135474

63.86%

Genetically altered without a harmful phenotype

56923

26.83%

Genetically altered with a harmful phenotype

19755

9.31%

Total

212152

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

14373

14373

Zebra fish

8185

8185

Total

22558

22558

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

20298

89.98%

Moderate

2040

9.04%

Severe

220

0.98%

Total

22558

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

2545

11.28%

Genetically altered without a harmful phenotype

7059

31.29%

Genetically altered with a harmful phenotype

12954

57.43%

Total

22558

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

4329

19.19%

Cardiovascular Blood and Lymphatic System

1439

6.38%

Nervous System

4069

18.04%

Gastrointestinal System including Liver

232

1.03%

Immune System

115

0.51%

Endocrine System/Metabolism

390

1.73%

Multisystemic

4970

22.03%

Other basic research

7014

31.09%

Total

22558

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

28632

28632

Rats

729

729

Total

29361

29361



Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

66

0.22%

Mild [up to and including]

28861

98.3%

Moderate

381

1.3%

Severe

53

0.18%

Total

29361

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

7912

26.95%

Genetically altered without a harmful phenotype

18527

63.1%

Genetically altered with a harmful phenotype

2922

9.95%

Total

29361

100.00%



Member State: Belgium, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

306605

60.46%

Rats

23207

4.58%

Guinea-Pigs

15539

3.06%

Hamsters (Syrian)

1147

0.23%

Mongolian gerbil

174

0.03%

Other Rodents

115

0.02%

Rabbits

57849

11.41%

Cats

53

0.01%

Dogs

334

0.07%

Ferrets

26

0.01%

Horses, donkeys and cross-breeds

135

0.03%

Pigs

4847

0.96%

Goats

77

0.02%

Sheep

628

0.12%

Cattle

1354

0.27%

Rhesus monkey

9

0%

Other Mammals

77

0.02%

Domestic fowl

39661

7.82%

Other birds

6887

1.36%

Reptiles

42

0.01%

Xenopus

866

0.17%

Other Amphibians

71

0.01%

Zebra fish

23912

4.71%

Other Fish

23538

4.64%

Total

507153

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

483302

95.3%

Animals born in the EU but not at a registered breeder

19519

3.85%

Animals born in rest of Europe

903

0.18%

Animals born in rest of world

3420

0.67%

Total

507144

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

9

100%

Total

9

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F2 or greater

9

100%

Total

9

100.00%

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

306605

314

306919

Rats

23207

397

23604

Guinea-Pigs

15539

2

15541

Hamsters (Syrian)

1147

1147

Mongolian gerbil

174

174

Other Rodents

115

115

Rabbits

57849

39

57888

Cats

53

8

61

Dogs

334

1522

1856

Ferrets

26

26

Horses, donkeys and cross-breeds

135

99

234

Pigs

4847

123

4970

Goats

77

1

78

Sheep

628

38

666

Cattle

1354

204

1558

Rhesus monkey

9

35

44

Other Mammals

77

63

140

Domestic fowl

39661

13

39674

Other birds

6887

251

7138

Reptiles

42

139

181

Xenopus

866

52

918

Other Amphibians

71

252

323

Zebra fish

23912

23912

Other Fish

23538

489

24027

Total

507153

4041

511194

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

243476

47.63%

Translational and applied research

116957

22.88%

Regulatory use and Routine production

141853

27.75%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

706

0.14%

Preservation of species

151

0.03%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

8051

1.57%

Total

511194

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

49489

20.33%

Cardiovascular Blood and Lymphatic System

10890

4.47%

Nervous System

37566

15.43%

Respiratory System

3403

1.4%

Gastrointestinal System including Liver

14181

5.82%

Musculoskeletal System

4058

1.67%

Immune System

68939

28.31%

Urogenital/Reproductive System

5450

2.24%

Sensory Organs (skin, eyes and ears)

4674

1.92%

Endocrine System/Metabolism

10658

4.38%

Multisystemic

2599

1.07%

Ethology / Animal Behaviour /Animal Biology

14701

6.04%

Other basic research

16868

6.93%

Total

243476

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

12720

10.88%

Human Infectious Disorders

15691

13.42%

Human Cardiovascular Disorders

1573

1.34%

Human Nervous and Mental Disorders

28677

24.52%

Human Respiratory Disorders

5945

5.08%

Human Gastrointestinal Disorders including Liver

977

0.84%

Human Musculoskeletal Disorders

783

0.67%

Human Immune Disorders

2039

1.74%

Human Urogenital/Reproductive Disorders

503

0.43%

Human Sensory Organ Disorders (skin, eyes and ears)

5441

4.65%

Human Endocrine/Metabolism Disorders

3722

3.18%

Other Human Disorders

40

0.03%

Animal Diseases and Disorders

17918

15.32%

Animal Welfare

3525

3.01%

Diagnosis of diseases

4292

3.67%

Non-regulatory toxicology and ecotoxicology

13111

11.21%

Total

116957

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

68615

48.37%

Other efficacy and tolerance testing

17201

12.13%

Toxicity and other safety testing including pharmacology

4133

2.91%

Routine production

51904

36.59%

Total

141853

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

8016

11.68%

Batch potency testing

57716

84.12%

Other quality controls

2883

4.2%

Total

68615

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1037

25.09%

Repeated dose toxicity

672

16.26%

Reproductive toxicity

290

7.02%

Developmental toxicity

11

0.27%

Neurotoxicity

20

0.48%

Kinetics

399

9.65%

Ecotoxicity

1418

34.31%

Safety testing in food and feed area

150

3.63%

Target animal safety

136

3.29%

Total

4133

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

50

4.82%

Non lethal methods

987

95.18%

Total

1037

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

505

75.15%

29 - 90 days

42

6.25%

> 90 days

125

18.6%

Total

672

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

1202

84.77%

Chronic toxicity

216

15.23%

Total

1418

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

62092

69.03%

Legislation on medicinal products for veterinary use and their residues

25534

28.39%

Medical devices legislation

779

0.87%

Industrial chemicals legislation

216

0.24%

Plant protection product legislation

52

0.06%

Food legislation including food contact material

74

0.08%

Other legislation

1202

1.34%

Total

89949

100.00%



Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

76304

84.83%

Legislation satisfying national requirements only [within EU]

50

0.06%

Legislation satisfying Non-EU requirements only

13595

15.11%

Total

89949

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

51804

99.81%

Other product types

100

0.19%

Total

51904

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

507153

99.21%

Yes

4041

0.79%

Total

511194

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

25003

4.89%

Mild [up to and including]

275109

53.82%

Moderate

128546

25.15%

Severe

82536

16.15%

Total

511194

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

395188

77.31%

Genetically altered without a harmful phenotype

100218

19.6%

Genetically altered with a harmful phenotype

15788

3.09%

Total

511194

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

24875

24875

Rats

222

222

Zebra fish

3544

979

4523

Total

28641

979

29620

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

1543

5.21%

Mild [up to and including]

20452

69.05%

Moderate

5403

18.24%

Severe

2222

7.5%

Total

29620

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

7096

23.96%

Genetically altered without a harmful phenotype

16407

55.39%

Genetically altered with a harmful phenotype

6117

20.65%

Total

29620

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

8598

29.33%

Cardiovascular Blood and Lymphatic System

2572

8.77%

Nervous System

5408

18.45%

Respiratory System

180

0.61%

Gastrointestinal System including Liver

2594

8.85%

Musculoskeletal System

909

3.1%

Immune System

1166

3.98%

Urogenital/Reproductive System

402

1.37%

Sensory Organs (skin, eyes and ears)

111

0.38%

Endocrine System/Metabolism

4203

14.34%

Multisystemic

3001

10.24%

Other basic research

175

0.6%

Total

29319

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Nervous and Mental Disorders

259

86.05%

Animal Diseases and Disorders

42

13.95%

Total

301

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

2249

11

2260

Total

2249

11

2260

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

1628

72.04%

Moderate

628

27.79%

Severe

4

0.18%

Total

2260

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

5

0.22%

Genetically altered without a harmful phenotype

1701

75.27%

Genetically altered with a harmful phenotype

554

24.51%

Total

2260

100.00%



Member State: Bulgaria, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

989

11.39%

Rats

1892

21.79%

Guinea-Pigs

1841

21.21%

Rabbits

568

6.54%

Cats

30

0.35%

Pigs

20

0.23%

Sheep

340

3.92%

Cattle

15

0.17%

Domestic fowl

680

7.83%

Rana

2306

26.56%

Total

8681

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

8651

99.65%

Animals born in the EU but not at a registered breeder

30

0.35%

Total

8681

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

989

989

Rats

1892

1892

Guinea-Pigs

1841

1841

Rabbits

568

568

Cats

30

30

Pigs

20

20

Sheep

340

340

Cattle

15

15

Domestic fowl

680

680

Rana

2306

2306

Total

8681

8681

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

2246

25.87%

Translational and applied research

19

0.22%

Regulatory use and Routine production

4126

47.53%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2290

26.38%

Total

8681

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Nervous System

1651

73.51%

Gastrointestinal System including Liver

11

0.49%

Musculoskeletal System

74

3.29%

Immune System

42

1.87%

Urogenital/Reproductive System

45

2%

Endocrine System/Metabolism

56

2.49%

Multisystemic

62

2.76%

Ethology / Animal Behaviour /Animal Biology

235

10.46%

Other basic research

70

3.12%

Total

2246

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Nervous and Mental Disorders

19

100%

Total

19

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

2843

68.9%

Toxicity and other safety testing including pharmacology

238

5.77%

Routine production

1045

25.33%

Total

4126

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

2843

100%

Total

2843

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

38

15.97%

Pharmaco-dynamics (incl safety pharmacology)

150

63.03%

Ecotoxicity

50

21.01%

Total

238

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

38

100%

Total

38

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Chronic toxicity

50

100%

Total

50

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

3081

100%

Total

3081

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

3081

100%

Total

3081

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Other product types

1045

100%

Total

1045

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

8681

100%

Total

8681

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Mild [up to and including]

4547

52.38%

Moderate

3869

44.57%

Severe

265

3.05%

Total

8681

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

8681

100%

Total

8681

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

No data reported

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported



Member State: Croatia, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

19710

70.13%

Rats

7638

27.18%

Guinea-Pigs

16

0.06%

Rabbits

426

1.52%

Pigs

2

0.01%

Sheep

28

0.1%

Cattle

30

0.11%

Domestic fowl

255

0.91%

Total

28105

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

27966

99.51%

Animals born in the EU but not at a registered breeder

60

0.21%

Animals born in rest of world

79

0.28%

Total

28105

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

19710

19710

Rats

7638

62

7700

Guinea-Pigs

16

5

21

Rabbits

426

426

Horses, donkeys and cross-breeds

25

25

Pigs

2

2

Sheep

28

11

39

Cattle

30

30

Domestic fowl

255

255

Total

28105

103

28208

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

22067

78.23%

Translational and applied research

2531

8.97%

Regulatory use and Routine production

2182

7.74%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1428

5.06%

Total

28208

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

1345

6.1%

Cardiovascular Blood and Lymphatic System

378

1.71%

Nervous System

1428

6.47%

Respiratory System

5721

25.93%

Gastrointestinal System including Liver

2069

9.38%

Musculoskeletal System

30

0.14%

Immune System

3764

17.06%

Urogenital/Reproductive System

234

1.06%

Sensory Organs (skin, eyes and ears)

688

3.12%

Endocrine System/Metabolism

384

1.74%

Multisystemic

4582

20.76%

Ethology / Animal Behaviour /Animal Biology

122

0.55%

Other basic research

1322

5.99%

Total

22067

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

230

9.09%

Human Infectious Disorders

1394

55.08%

Human Cardiovascular Disorders

510

20.15%

Human Nervous and Mental Disorders

214

8.46%

Human Musculoskeletal Disorders

28

1.11%

Human Endocrine/Metabolism Disorders

60

2.37%

Animal Diseases and Disorders

30

1.19%

Non-regulatory toxicology and ecotoxicology

65

2.57%

Total

2531

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1585

72.64%

Toxicity and other safety testing including pharmacology

556

25.48%

Routine production

41

1.88%

Total

2182

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

262

16.53%

Batch potency testing

128

8.08%

Other quality controls

1195

75.39%

Total

1585

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

556

100%

Total

556

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

Non lethal methods

556

100%

Total

556

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1758

82.11%

Legislation on medicinal products for veterinary use and their residues

383

17.89%

Total

2141

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2141

100%

Total

2141

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

41

100%

Total

41

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

28105

99.63%

Yes

103

0.37%

Total

28208

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

2965

10.51%

Mild [up to and including]

8242

29.22%

Moderate

11403

40.42%

Severe

5598

19.85%

Total

28208

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

25797

91.45%

Genetically altered without a harmful phenotype

2356

8.35%

Genetically altered with a harmful phenotype

55

0.19%

Total

28208

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Zebra fish

230

230

Total

230

230

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

40

17.39%

Moderate

190

82.61%

Total

230

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

230

100%

Total

230

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Non-regulatory toxicology and ecotoxicology

230

100%

Total

230

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

96

96

Total

96

96

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

96

100%

Total

96

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

96

100%

Total

96

100.00%

Member State: Cyprus, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

1209

100%

Total

1209

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1209

100%

Total

1209

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

1209

1209

Total

1209

1209

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

839

69.4%

Translational and applied research

370

30.6%

Total

1209

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

129

15.38%

Cardiovascular Blood and Lymphatic System

17

2.03%

Nervous System

368

43.86%

Musculoskeletal System

275

32.78%

Sensory Organs (skin, eyes and ears)

50

5.96%

Total

839

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

370

100%

Total

370

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

No data reported

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

No data reported

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

No data reported

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

1209

100%

Total

1209

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Mild [up to and including]

1197

99.01%

Moderate

12

0.99%

Total

1209

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

623

51.53%

Genetically altered without a harmful phenotype

586

48.47%

Total

1209

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

No data reported

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported



Member State: Czechia, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

71954

33.92%

Rats

24809

11.69%

Guinea-Pigs

1377

0.65%

Hamsters (Syrian)

15

0.01%

Mongolian gerbil

46

0.02%

Other Rodents

635

0.3%

Rabbits

2031

0.96%

Cats

121

0.06%

Dogs

437

0.21%

Ferrets

1

0%

Other carnivores

1

0%

Horses, donkeys and cross-breeds

90

0.04%

Pigs

1893

0.89%

Goats

91

0.04%

Sheep

524

0.25%

Cattle

1413

0.67%

Domestic fowl

21166

9.98%

Other birds

4234

2%

Reptiles

558

0.26%

Xenopus

50

0.02%

Other Amphibians

531

0.25%

Zebra fish

5414

2.55%

Other Fish

74753

35.24%

Total

212144

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

202387

95.4%

Animals born in the EU but not at a registered breeder

9222

4.35%

Animals born in rest of world

535

0.25%

Total

212144

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

71954

1042

72996

Rats

24809

46

24855

Guinea-Pigs

1377

6

1383

Hamsters (Syrian)

15

15

Mongolian gerbil

46

46

Other Rodents

635

635

Rabbits

2031

102

2133

Cats

121

11

132

Dogs

437

200

637

Ferrets

1

1

Other carnivores

1

1

Horses, donkeys and cross-breeds

90

15

105

Pigs

1893

554

2447

Goats

91

6

97

Sheep

524

394

918

Cattle

1413

1321

2734

Domestic fowl

21166

51

21217

Other birds

4234

26

4260

Reptiles

558

558

Xenopus

50

50

Other Amphibians

531

531

Zebra fish

5414

5414

Other Fish

74753

108

74861

Total

212144

3882

216026

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

74438

34.46%

Translational and applied research

27640

12.79%

Regulatory use and Routine production

54133

25.06%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

47646

22.06%

Preservation of species

6437

2.98%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

5732

2.65%

Total

216026

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

7593

10.2%

Cardiovascular Blood and Lymphatic System

6413

8.62%

Nervous System

8951

12.02%

Respiratory System

503

0.68%

Gastrointestinal System including Liver

1727

2.32%

Musculoskeletal System

484

0.65%

Immune System

11401

15.32%

Urogenital/Reproductive System

6488

8.72%

Sensory Organs (skin, eyes and ears)

525

0.71%

Endocrine System/Metabolism

3777

5.07%

Multisystemic

6311

8.48%

Ethology / Animal Behaviour /Animal Biology

7542

10.13%

Other basic research

12723

17.09%

Total

74438

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

3761

13.61%

Human Infectious Disorders

1309

4.74%

Human Cardiovascular Disorders

1308

4.73%

Human Nervous and Mental Disorders

2009

7.27%

Human Gastrointestinal Disorders including Liver

861

3.12%

Human Musculoskeletal Disorders

114

0.41%

Human Immune Disorders

303

1.1%

Human Urogenital/Reproductive Disorders

496

1.79%

Human Sensory Organ Disorders (skin, eyes and ears)

112

0.41%

Human Endocrine/Metabolism Disorders

2066

7.47%

Other Human Disorders

379

1.37%

Animal Diseases and Disorders

3643

13.18%

Animal Welfare

3897

14.1%

Diagnosis of diseases

7373

26.68%

Non-regulatory toxicology and ecotoxicology

9

0.03%

Total

27640

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

12209

22.55%

Other efficacy and tolerance testing

326

0.6%

Toxicity and other safety testing including pharmacology

25293

46.72%

Routine production

16305

30.12%

Total

54133

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

523

4.28%

Pyrogenicity testing

81

0.66%

Batch potency testing

11397

93.35%

Other quality controls

208

1.7%

Total

12209

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

4646

18.37%

Skin sensitisation

637

2.52%

Eye irritation/corrosion

18

0.07%

Repeated dose toxicity

1440

5.69%

Reproductive toxicity

3136

12.4%

Developmental toxicity

274

1.08%

Kinetics

144

0.57%

Pharmaco-dynamics (incl safety pharmacology)

24

0.09%

Ecotoxicity

14374

56.83%

Safety testing in food and feed area

438

1.73%

Target animal safety

50

0.2%

Other toxicity/safety testing

112

0.44%

Total

25293

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

994

21.39%

Other lethal methods

3652

78.61%

Total

4646

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

482

33.47%

29 - 90 days

552

38.33%

> 90 days

406

28.19%

Total

1440

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

12714

88.45%

Other ecotoxicity

1660

11.55%

Total

14374

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

2682

7.09%

Legislation on medicinal products for veterinary use and their residues

12127

32.06%

Medical devices legislation

719

1.9%

Industrial chemicals legislation

4345

11.49%

Food legislation including food contact material

170

0.45%

Feed legislation including legislation for the safety of target animals, workers and environment

525

1.39%

Other legislation

17260

45.63%

Total

37828

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

28179

74.49%

Legislation satisfying national requirements only [within EU]

9649

25.51%

Total

37828

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

777

4.77%

Monoclonal antibody by mouse ascites method

230

1.41%

Other product types

15298

93.82%

Total

16305

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

212144

98.2%

Yes

3882

1.8%

Total

216026

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

13419

6.21%

Mild [up to and including]

93112

43.1%

Moderate

93344

43.21%

Severe

16151

7.48%

Total

216026

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

199255

92.24%

Genetically altered without a harmful phenotype

13888

6.43%

Genetically altered with a harmful phenotype

2883

1.33%

Total

216026

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

9007

216

9223

Rats

2112

2112

Zebra fish

14351

14351

Total

11119

14567

25686

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

5695

22.17%

Mild [up to and including]

17018

66.25%

Moderate

2973

11.57%

Total

25686

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

25686

100%

Total

25686

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

1325

5.16%

Cardiovascular Blood and Lymphatic System

16566

64.54%

Nervous System

155

0.6%

Immune System

1726

6.72%

Urogenital/Reproductive System

5617

21.88%

Other basic research

280

1.09%

Total

25669

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Animal Welfare

17

100%

Total

17

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Member State: Denmark, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

159566

68.84%

Rats

37955

16.37%

Guinea-Pigs

2932

1.26%

Hamsters (Syrian)

282

0.12%

Other Rodents

3

0%

Rabbits

2439

1.05%

Dogs

69

0.03%

Ferrets

4

0%

Other carnivores

935

0.4%

Horses, donkeys and cross-breeds

55

0.02%

Pigs

5481

2.36%

Goats

1

0%

Sheep

56

0.02%

Cattle

3663

1.58%

Other Mammals

28

0.01%

Domestic fowl

402

0.17%

Other birds

408

0.18%

Reptiles

269

0.12%

Xenopus

75

0.03%

Other Amphibians

47

0.02%

Zebra fish

1587

0.68%

Other Fish

15538

6.7%

Total

231795

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

201515

86.94%

Animals born in the EU but not at a registered breeder

24528

10.58%

Animals born in rest of Europe

537

0.23%

Animals born in rest of world

5215

2.25%

Total

231795

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

159566

856

160422

Rats

37955

543

38498

Guinea-Pigs

2932

15

2947

Hamsters (Syrian)

282

282

Other Rodents

3

3

Rabbits

2439

4

2443

Dogs

69

145

214

Ferrets

4

4

Other carnivores

935

100

1035

Horses, donkeys and cross-breeds

55

64

119

Pigs

5481

320

5801

Goats

1

1

Sheep

56

10

66

Cattle

3663

14

3677

Other Mammals

28

28

Domestic fowl

402

64

466

Other birds

408

408

Reptiles

269

20

289

Rana

4

4

Xenopus

75

210

285

Other Amphibians

47

47

Zebra fish

1587

1587

Other Fish

15538

68

15606

Total

231795

2437

234232

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

79399

33.9%

Translational and applied research

121977

52.08%

Regulatory use and Routine production

19865

8.48%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

2875

1.23%

Preservation of species

5637

2.41%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

4463

1.91%

Forensic enquiries

16

0.01%

Total

234232

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

6469

8.15%

Cardiovascular Blood and Lymphatic System

4268

5.38%

Nervous System

18149

22.86%

Respiratory System

2444

3.08%

Gastrointestinal System including Liver

2478

3.12%

Musculoskeletal System

2462

3.1%

Immune System

22727

28.62%

Urogenital/Reproductive System

2220

2.8%

Sensory Organs (skin, eyes and ears)

77

0.1%

Endocrine System/Metabolism

12359

15.57%

Multisystemic

485

0.61%

Ethology / Animal Behaviour /Animal Biology

2363

2.98%

Other basic research

2898

3.65%

Total

79399

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

18429

15.11%

Human Infectious Disorders

7665

6.28%

Human Cardiovascular Disorders

2016

1.65%

Human Nervous and Mental Disorders

31340

25.69%

Human Respiratory Disorders

176

0.14%

Human Gastrointestinal Disorders including Liver

762

0.62%

Human Musculoskeletal Disorders

378

0.31%

Human Immune Disorders

4959

4.07%

Human Urogenital/Reproductive Disorders

647

0.53%

Human Sensory Organ Disorders (skin, eyes and ears)

336

0.28%

Human Endocrine/Metabolism Disorders

37015

30.35%

Other Human Disorders

9168

7.52%

Animal Diseases and Disorders

5708

4.68%

Animal Welfare

1568

1.29%

Diagnosis of diseases

1023

0.84%

Non-regulatory toxicology and ecotoxicology

787

0.65%

Total

121977

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

8139

40.97%

Other efficacy and tolerance testing

725

3.65%

Toxicity and other safety testing including pharmacology

10257

51.63%

Routine production

744

3.75%

Total

19865

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

2504

30.77%

Batch potency testing

5601

68.82%

Other quality controls

34

0.42%

Total

8139

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

3968

38.69%

Skin irritation/corrosion

28

0.27%

Skin sensitisation

177

1.73%

Repeated dose toxicity

2205

21.5%

Reproductive toxicity

935

9.12%

Kinetics

818

7.98%

Pharmaco-dynamics (incl safety pharmacology)

26

0.25%

Ecotoxicity

2100

20.47%

Total

10257

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

3968

100%

Total

3968

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

1382

62.68%

29 - 90 days

586

26.58%

> 90 days

237

10.75%

Total

2205

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

120

5.71%

Chronic toxicity

1800

85.71%

Bioaccumulation

180

8.57%

Total

2100

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

16100

84.2%

Industrial chemicals legislation

2987

15.62%

Other legislation

34

0.18%

Total

19121

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

19021

99.48%

Legislation satisfying national requirements only [within EU]

100

0.52%

Total

19121

100.00%



Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

288

38.71%

Other product types

456

61.29%

Total

744

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

231795

98.96%

Yes

2437

1.04%

Total

234232

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

22792

9.73%

Mild [up to and including]

123841

52.87%

Moderate

85837

36.65%

Severe

1762

0.75%

Total

234232

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

195240

83.35%

Genetically altered without a harmful phenotype

27228

11.62%

Genetically altered with a harmful phenotype

11764

5.02%

Total

234232

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

3686

3686

Pigs

2

2

Total

3688

3688

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

79

2.14%

Mild [up to and including]

3143

85.22%

Moderate

466

12.64%

Total

3688

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

2803

76%

Genetically altered without a harmful phenotype

679

18.41%

Genetically altered with a harmful phenotype

206

5.59%

Total

3688

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

258

7.33%

Cardiovascular Blood and Lymphatic System

2

0.06%

Nervous System

92

2.61%

Musculoskeletal System

818

23.25%

Endocrine System/Metabolism

273

7.76%

Ethology / Animal Behaviour /Animal Biology

91

2.59%

Other basic research

1985

56.41%

Total

3519

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Nervous and Mental Disorders

169

100%

Total

169

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

29

29

Total

29

29

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

29

100%

Total

29

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered with a harmful phenotype

29

100%

Total

29

100.00%



Member State: Estonia, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

2168

81.38%

Rats

296

11.11%

Pigs

4

0.15%

Cattle

16

0.6%

Other birds

180

6.76%

Total

2664

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2484

93.24%

Animals born in the EU but not at a registered breeder

180

6.76%

Total

2664

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

2168

2168

Rats

296

296

Pigs

4

4

Cattle

16

16

Other birds

180

180

Total

2664

2664

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

2304

86.49%

Translational and applied research

210

7.88%

Regulatory use and Routine production

112

4.2%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

38

1.43%

Total

2664

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

985

42.75%

Cardiovascular Blood and Lymphatic System

93

4.04%

Nervous System

407

17.66%

Gastrointestinal System including Liver

32

1.39%

Musculoskeletal System

88

3.82%

Immune System

99

4.3%

Sensory Organs (skin, eyes and ears)

32

1.39%

Endocrine System/Metabolism

219

9.51%

Multisystemic

153

6.64%

Ethology / Animal Behaviour /Animal Biology

180

7.81%

Other basic research

16

0.69%

Total

2304

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Respiratory Disorders

210

100%

Total

210

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Toxicity and other safety testing including pharmacology

112

100%

Total

112

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Repeated dose toxicity

38

33.93%

Carcinogenicity

74

66.07%

Total

112

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

38

100%

Total

38

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

112

100%

Total

112

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

112

100%

Total

112

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

2664

100%

Total

2664

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

122

4.58%

Mild [up to and including]

955

35.85%

Moderate

1312

49.25%

Severe

275

10.32%

Total

2664

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

1940

72.82%

Genetically altered without a harmful phenotype

724

27.18%

Total

2664

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

16

16

Rats

72

72

Total

88

88

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

10

11.36%

Mild [up to and including]

36

40.91%

Moderate

42

47.73%

Total

88

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

16

18.18%

Genetically altered without a harmful phenotype

72

81.82%

Total

88

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Nervous System

88

100%

Total

88

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

394

394

Total

394

394

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

394

100%

Total

394

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

394

100%

Total

394

100.00%

Member State: Finland, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

48580

49.9%

Rats

13467

13.83%

Guinea-Pigs

9

0.01%

Hamsters (Syrian)

149

0.15%

Other Rodents

690

0.71%

Rabbits

223

0.23%

Cats

311

0.32%

Dogs

3035

3.12%

Other carnivores

107

0.11%

Horses, donkeys and cross-breeds

30

0.03%

Pigs

632

0.65%

Sheep

1319

1.35%

Cattle

207

0.21%

Other Mammals

1521

1.56%

Domestic fowl

8485

8.72%

Other birds

404

0.41%

Zebra fish

6454

6.63%

Other Fish

11729

12.05%

Total

97352

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

71217

73.15%

Animals born in the EU but not at a registered breeder

23562

24.2%

Animals born in rest of Europe

5

0.01%

Animals born in rest of world

2568

2.64%

Total

97352

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

48580

51

48631

Rats

13467

13467

Guinea-Pigs

9

9

Hamsters (Syrian)

149

149

Other Rodents

690

690

Rabbits

223

4

227

Cats

311

311

Dogs

3035

26

3061

Other carnivores

107

107

Horses, donkeys and cross-breeds

30

47

77

Pigs

632

632

Sheep

1319

1319

Cattle

207

9

216

Other Mammals

1521

12

1533

Domestic fowl

8485

8485

Other birds

404

404

Zebra fish

6454

6454

Other Fish

11729

11729

Total

97352

149

97501

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

54625

56.03%

Translational and applied research

33315

34.17%

Regulatory use and Routine production

7895

8.1%

Preservation of species

60

0.06%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1606

1.65%

Total

97501

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

6529

11.95%

Cardiovascular Blood and Lymphatic System

5098

9.33%

Nervous System

10383

19.01%

Respiratory System

80

0.15%

Gastrointestinal System including Liver

545

1%

Musculoskeletal System

337

0.62%

Immune System

10325

18.9%

Urogenital/Reproductive System

181

0.33%

Sensory Organs (skin, eyes and ears)

268

0.49%

Endocrine System/Metabolism

900

1.65%

Multisystemic

6005

10.99%

Ethology / Animal Behaviour /Animal Biology

7546

13.81%

Other basic research

6428

11.77%

Total

54625

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

5016

15.06%

Human Infectious Disorders

860

2.58%

Human Cardiovascular Disorders

662

1.99%

Human Nervous and Mental Disorders

19579

58.77%

Human Gastrointestinal Disorders including Liver

117

0.35%

Human Musculoskeletal Disorders

605

1.82%

Human Immune Disorders

71

0.21%

Human Urogenital/Reproductive Disorders

8

0.02%

Human Sensory Organ Disorders (skin, eyes and ears)

470

1.41%

Human Endocrine/Metabolism Disorders

371

1.11%

Other Human Disorders

755

2.27%

Animal Diseases and Disorders

4384

13.16%

Animal Welfare

226

0.68%

Diagnosis of diseases

123

0.37%

Non-regulatory toxicology and ecotoxicology

68

0.2%

Total

33315

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

3395

43%

Other efficacy and tolerance testing

156

1.98%

Toxicity and other safety testing including pharmacology

2868

36.33%

Routine production

1476

18.7%

Total

7895

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

3395

100%

Total

3395

100.00%



Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Repeated dose toxicity

134

4.67%

Kinetics

1171

40.83%

Pharmaco-dynamics (incl safety pharmacology)

1556

54.25%

Other toxicity/safety testing

7

0.24%

Total

2868

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

134

100%

Total

134

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

2992

46.61%

Legislation on medicinal products for veterinary use and their residues

3395

52.89%

Feed legislation including legislation for the safety of target animals, workers and environment

32

0.5%

Total

6419

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

6419

100%

Total

6419

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

296

20.05%

Other product types

1180

79.95%

Total

1476

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

97352

99.85%

Yes

149

0.15%

Total

97501

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

8735

8.96%

Mild [up to and including]

46758

47.96%

Moderate

33282

34.14%

Severe

8726

8.95%

Total

97501

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

71470

73.3%

Genetically altered without a harmful phenotype

17743

18.2%

Genetically altered with a harmful phenotype

8288

8.5%

Total

97501

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

4155

4155

Rats

5

5

Zebra fish

699

699

Total

4859

4859

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

347

7.14%

Mild [up to and including]

2805

57.73%

Moderate

1694

34.86%

Severe

13

0.27%

Total

4859

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

1607

33.07%

Genetically altered without a harmful phenotype

2756

56.72%

Genetically altered with a harmful phenotype

496

10.21%

Total

4859

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

262

5.63%

Cardiovascular Blood and Lymphatic System

47

1.01%

Nervous System

1522

32.71%

Immune System

699

15.02%

Endocrine System/Metabolism

487

10.47%

Multisystemic

1582

34%

Other basic research

54

1.16%

Total

4653

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Nervous and Mental Disorders

124

60.19%

Human Sensory Organ Disorders (skin, eyes and ears)

7

3.4%

Human Endocrine/Metabolism Disorders

71

34.47%

Other Human Disorders

4

1.94%

Total

206

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

215

215

Total

215

215



Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

207

96.28%

Moderate

8

3.72%

Total

215

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

3

1.4%

Genetically altered without a harmful phenotype

179

83.26%

Genetically altered with a harmful phenotype

33

15.35%

Total

215

100.00%



Member State: France, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

1011925

57.57%

Rats

173535

9.87%

Guinea-Pigs

44976

2.56%

Hamsters (Syrian)

6529

0.37%

Hamsters (Chinese)

167

0.01%

Mongolian gerbil

429

0.02%

Other Rodents

857

0.05%

Rabbits

124544

7.09%

Cats

315

0.02%

Dogs

2752

0.16%

Ferrets

148

0.01%

Other carnivores

24

0%

Horses, donkeys and cross-breeds

109

0.01%

Pigs

9261

0.53%

Goats

311

0.02%

Sheep

2633

0.15%

Cattle

956

0.05%

Prosimians

86

0%

Marmoset and tamarins

131

0.01%

Cynomolgus monkey

2001

0.11%

Rhesus monkey

26

0%

Vervets (Chlorocebus spp.)

33

0%

Baboons

11

0%

Squirrel monkey

7

0%

Other species of Old World Monkeys (Cercopithecoidea)

9

0%

Other Mammals

18125

1.03%

Domestic fowl

42582

2.42%

Other birds

26997

1.54%

Reptiles

14

0%

Rana

118

0.01%

Xenopus

3570

0.2%

Other Amphibians

742

0.04%

Zebra fish

16199

0.92%

Other Fish

267714

15.23%

Cephalopods

1

0%

Total

1757837

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1501087

85.51%

Animals born in the EU but not at a registered breeder

152224

8.67%

Animals born in rest of Europe

48610

2.77%

Animals born in rest of world

53612

3.05%

Total

1755533

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

236

10.24%

Animals born in rest of Europe

5

0.22%

Animals born in Asia

130

5.64%

Animals born in America

35

1.52%

Animals born in Africa

1729

75.04%

Animals born elsewhere

169

7.34%

Total

2304

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F1

885

38.41%

F2 or greater

1285

55.77%

Self-sustaining colony

134

5.82%

Total

2304

100.00%



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

1011925

16158

1028083

Rats

173535

6078

179613

Guinea-Pigs

44976

58

45034

Hamsters (Syrian)

6529

6529

Hamsters (Chinese)

167

167

Mongolian gerbil

429

429

Other Rodents

857

100

957

Rabbits

124544

2354

126898

Cats

315

552

867

Dogs

2752

1344

4096

Ferrets

148

148

Other carnivores

24

3

27

Horses, donkeys and cross-breeds

109

196

305

Pigs

9261

1085

10346

Goats

311

527

838

Sheep

2633

2763

5396

Cattle

956

821

1777

Prosimians

86

86

Marmoset and tamarins

131

93

224

Cynomolgus monkey

2001

1278

3279

Rhesus monkey

26

45

71

Vervets (Chlorocebus spp.)

33

5

38

Baboons

11

21

32

Squirrel monkey

7

7

Other species of Old World Monkeys (Cercopithecoidea)

9

9

Other Mammals

18125

400

18525

Domestic fowl

42582

562

43144

Other birds

26997

228

27225

Reptiles

14

3448

3462

Rana

118

118

Xenopus

3570

1327

4897

Other Amphibians

742

742

Zebra fish

16199

600

16799

Other Fish

267714

360

268074

Cephalopods

1

1

Total

1757837

40406

1798243



Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

687105

38.21%

Translational and applied research

477884

26.58%

Regulatory use and Routine production

574030

31.92%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

4918

0.27%

Preservation of species

18786

1.04%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

35512

1.97%

Forensic enquiries

8

0%

Total

1798243

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

92211

13.42%

Cardiovascular Blood and Lymphatic System

32298

4.7%

Nervous System

123850

18.02%

Respiratory System

12314

1.79%

Gastrointestinal System including Liver

27363

3.98%

Musculoskeletal System

17391

2.53%

Immune System

90438

13.16%

Urogenital/Reproductive System

18745

2.73%

Sensory Organs (skin, eyes and ears)

5415

0.79%

Endocrine System/Metabolism

40474

5.89%

Multisystemic

7270

1.06%

Ethology / Animal Behaviour /Animal Biology

161945

23.57%

Other basic research

57391

8.35%

Total

687105

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

120252

25.16%

Human Infectious Disorders

52555

11%

Human Cardiovascular Disorders

14990

3.14%

Human Nervous and Mental Disorders

46285

9.69%

Human Respiratory Disorders

6669

1.4%

Human Gastrointestinal Disorders including Liver

12366

2.59%

Human Musculoskeletal Disorders

13833

2.89%

Human Immune Disorders

19048

3.99%

Human Urogenital/Reproductive Disorders

2240

0.47%

Human Sensory Organ Disorders (skin, eyes and ears)

7750

1.62%

Human Endocrine/Metabolism Disorders

12181

2.55%

Other Human Disorders

9642

2.02%

Animal Diseases and Disorders

37908

7.93%

Animal Welfare

216

0.05%

Diagnosis of diseases

97413

20.38%

Plant diseases

89

0.02%

Non-regulatory toxicology and ecotoxicology

24447

5.12%

Total

477884

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

201610

35.12%

Other efficacy and tolerance testing

83928

14.62%

Toxicity and other safety testing including pharmacology

113238

19.73%

Routine production

175254

30.53%

Total

574030

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

20294

10.07%

Pyrogenicity testing

6191

3.07%

Batch potency testing

138017

68.46%

Other quality controls

37108

18.41%

Total

201610

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

3294

2.91%

Skin irritation/corrosion

1754

1.55%

Skin sensitisation

14019

12.38%

Eye irritation/corrosion

253

0.22%

Repeated dose toxicity

24250

21.42%

Carcinogenicity

2295

2.03%

Genotoxicity

486

0.43%

Reproductive toxicity

14165

12.51%

Developmental toxicity

7483

6.61%

Kinetics

18338

16.19%

Pharmaco-dynamics (incl safety pharmacology)

9821

8.67%

Phototoxicity

521

0.46%

Ecotoxicity

13533

11.95%

Safety testing in food and feed area

1570

1.39%

Target animal safety

171

0.15%

Other toxicity/safety testing

1285

1.13%

Total

113238

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

702

21.31%

Other lethal methods

561

17.03%

Non lethal methods

2031

61.66%

Total

3294

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

12892

53.16%

29 - 90 days

6543

26.98%

> 90 days

4815

19.86%

Total

24250

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

10955

80.95%

Chronic toxicity

1107

8.18%

Bioaccumulation

846

6.25%

Other ecotoxicity

625

4.62%

Total

13533

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

226886

56.9%

Legislation on medicinal products for veterinary use and their residues

55686

13.96%

Medical devices legislation

25090

6.29%

Industrial chemicals legislation

12737

3.19%

Plant protection product legislation

4541

1.14%

Biocides legislation

757

0.19%

Food legislation including food contact material

698

0.18%

Feed legislation including legislation for the safety of target animals, workers and environment

72087

18.08%

Other legislation

294

0.07%

Total

398776

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

392531

98.43%

Legislation satisfying national requirements only [within EU]

1470

0.37%

Legislation satisfying Non-EU requirements only

4775

1.2%

Total

398776

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

74243

42.36%

Monoclonal antibody by mouse ascites method

44198

25.22%

Other product types

56813

32.42%

Total

175254

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

1757837

97.75%

Yes

40406

2.25%

Total

1798243

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

99949

5.56%

Mild [up to and including]

636482

35.39%

Moderate

739008

41.1%

Severe

322804

17.95%

Total

1798243

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

1469131

81.7%

Genetically altered without a harmful phenotype

285514

15.88%

Genetically altered with a harmful phenotype

43598

2.42%

Total

1798243

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

36512

180

36692

Rats

3346

3346

Rabbits

306

306

Zebra fish

5080

5080

Total

45244

180

45424

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

3145

6.92%

Mild [up to and including]

18783

41.35%

Moderate

22237

48.95%

Severe

1259

2.77%

Total

45424

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

16437

36.19%

Genetically altered without a harmful phenotype

23553

51.85%

Genetically altered with a harmful phenotype

5434

11.96%

Total

45424

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

2002

4.56%

Cardiovascular Blood and Lymphatic System

279

0.64%

Nervous System

17558

39.96%

Gastrointestinal System including Liver

713

1.62%

Musculoskeletal System

110

0.25%

Immune System

1755

3.99%

Urogenital/Reproductive System

1161

2.64%

Sensory Organs (skin, eyes and ears)

20

0.05%

Endocrine System/Metabolism

234

0.53%

Multisystemic

13626

31.01%

Ethology / Animal Behaviour /Animal Biology

2511

5.72%

Other basic research

3967

9.03%

Total

43936

100.00%



Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cancer

91

6.12%

Human Cardiovascular Disorders

213

14.31%

Human Nervous and Mental Disorders

63

4.23%

Human Gastrointestinal Disorders including Liver

7

0.47%

Human Musculoskeletal Disorders

648

43.55%

Human Sensory Organ Disorders (skin, eyes and ears)

10

0.67%

Human Endocrine/Metabolism Disorders

321

21.57%

Other Human Disorders

100

6.72%

Animal Diseases and Disorders

35

2.35%

Total

1488

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

69742

69742

Rats

755

755

Dogs

10

10

Total

70507

70507

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

48518

68.81%

Moderate

19608

27.81%

Severe

2381

3.38%

Total

70507

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

66463

94.26%

Genetically altered with a harmful phenotype

4044

5.74%

Total

70507

100.00%



Member State: Germany, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

1171550

65.33%

Rats

245998

13.72%

Guinea-Pigs

14349

0.8%

Hamsters (Syrian)

1217

0.07%

Hamsters (Chinese)

8

0%

Mongolian gerbil

4154

0.23%

Other Rodents

9950

0.55%

Rabbits

89147

4.97%

Cats

431

0.02%

Dogs

1720

0.1%

Ferrets

172

0.01%

Other carnivores

535

0.03%

Horses, donkeys and cross-breeds

1013

0.06%

Pigs

16069

0.9%

Goats

195

0.01%

Sheep

2832

0.16%

Cattle

5842

0.33%

Prosimians

12

0%

Marmoset and tamarins

197

0.01%

Cynomolgus monkey

2387

0.13%

Rhesus monkey

67

0%

Baboons

14

0%

Squirrel monkey

1

0%

Other Mammals

1259

0.07%

Domestic fowl

24463

1.36%

Other birds

11339

0.63%

Reptiles

351

0.02%

Rana

377

0.02%

Xenopus

3405

0.19%

Other Amphibians

2652

0.15%

Zebra fish

87413

4.87%

Other Fish

94180

5.25%

Total

1793299

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1663522

92.9%

Animals born in the EU but not at a registered breeder

98960

5.53%

Animals born in rest of Europe

15127

0.84%

Animals born in rest of world

13012

0.73%

Total

1790621

100.00%



Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

350

13.07%

Animals born in Asia

1699

63.44%

Animals born in Africa

628

23.45%

Animals born elsewhere

1

0.04%

Total

2678

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F1

338

12.62%

F2 or greater

1786

66.69%

Self-sustaining colony

554

20.69%

Total

2678

100.00%



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

1171550

17159

1188709

Rats

245998

4481

250479

Guinea-Pigs

14349

502

14851

Hamsters (Syrian)

1217

5

1222

Hamsters (Chinese)

8

8

Mongolian gerbil

4154

101

4255

Other Rodents

9950

9950

Rabbits

89147

3497

92644

Cats

431

287

718

Dogs

1720

1610

3330

Ferrets

172

24

196

Other carnivores

535

535

Horses, donkeys and cross-breeds

1013

196

1209

Pigs

16069

1214

17283

Goats

195

17

212

Sheep

2832

221

3053

Cattle

5842

490

6332

Prosimians

12

75

87

Marmoset and tamarins

197

17

214

Cynomolgus monkey

2387

615

3002

Rhesus monkey

67

50

117

Vervets (Chlorocebus spp.)

15

15

Baboons

14

14

Squirrel monkey

1

1

Other species of Old World Monkeys (Cercopithecoidea)

12

12

Other Mammals

1259

93

1352

Domestic fowl

24463

457

24920

Other birds

11339

661

12000

Reptiles

351

18

369

Rana

377

377

Xenopus

3405

1141

4546

Other Amphibians

2652

2652

Zebra fish

87413

87413

Other Fish

94180

30

94210

Total

1793299

32988

1826287



Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

875421

47.93%

Translational and applied research

291152

15.94%

Regulatory use and Routine production

556946

30.5%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

8491

0.46%

Preservation of species

41156

2.25%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

53121

2.91%

Total

1826287

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

85330

9.75%

Cardiovascular Blood and Lymphatic System

84382

9.64%

Nervous System

194683

22.24%

Respiratory System

23256

2.66%

Gastrointestinal System including Liver

30152

3.44%

Musculoskeletal System

16529

1.89%

Immune System

183041

20.91%

Urogenital/Reproductive System

14651

1.67%

Sensory Organs (skin, eyes and ears)

20387

2.33%

Endocrine System/Metabolism

50807

5.8%

Multisystemic

42693

4.88%

Ethology / Animal Behaviour /Animal Biology

46171

5.27%

Other basic research

83339

9.52%

Total

875421

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

124509

42.76%

Human Infectious Disorders

17913

6.15%

Human Cardiovascular Disorders

15246

5.24%

Human Nervous and Mental Disorders

36680

12.6%

Human Respiratory Disorders

13197

4.53%

Human Gastrointestinal Disorders including Liver

13424

4.61%

Human Musculoskeletal Disorders

3926

1.35%

Human Immune Disorders

11314

3.89%

Human Urogenital/Reproductive Disorders

4613

1.58%

Human Sensory Organ Disorders (skin, eyes and ears)

5491

1.89%

Human Endocrine/Metabolism Disorders

8031

2.76%

Other Human Disorders

1223

0.42%

Animal Diseases and Disorders

17368

5.97%

Animal Welfare

6271

2.15%

Diagnosis of diseases

2488

0.85%

Plant diseases

69

0.02%

Non-regulatory toxicology and ecotoxicology

9389

3.22%

Total

291152

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

188089

33.77%

Other efficacy and tolerance testing

32991

5.92%

Toxicity and other safety testing including pharmacology

260473

46.77%

Routine production

75393

13.54%

Total

556946

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

19382

10.3%

Pyrogenicity testing

5591

2.97%

Batch potency testing

161272

85.74%

Other quality controls

1844

0.98%

Total

188089

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

10357

3.98%

Skin irritation/corrosion

884

0.34%

Skin sensitisation

8711

3.34%

Eye irritation/corrosion

171

0.07%

Repeated dose toxicity

19136

7.35%

Carcinogenicity

1961

0.75%

Genotoxicity

3522

1.35%

Reproductive toxicity

21926

8.42%

Developmental toxicity

35887

13.78%

Neurotoxicity

86

0.03%

Kinetics

31782

12.2%

Pharmaco-dynamics (incl safety pharmacology)

79250

30.43%

Ecotoxicity

38843

14.91%

Safety testing in food and feed area

1721

0.66%

Target animal safety

3423

1.31%

Other toxicity/safety testing

2813

1.08%

Total

260473

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

4136

39.93%

Other lethal methods

182

1.76%

Non lethal methods

6039

58.31%

Total

10357

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

13183

68.89%

29 - 90 days

4136

21.61%

> 90 days

1817

9.5%

Total

19136

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

6957

17.91%

Chronic toxicity

16704

43%

Reproductive ecotoxicity

904

2.33%

Endocrine activity

5840

15.03%

Bioaccumulation

1807

4.65%

Other ecotoxicity

6631

17.07%

Total

38843

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

340657

70.74%

Legislation on medicinal products for veterinary use and their residues

23605

4.9%

Medical devices legislation

12591

2.61%

Industrial chemicals legislation

50430

10.47%

Plant protection product legislation

46143

9.58%

Biocides legislation

2284

0.47%

Food legislation including food contact material

14

0%

Feed legislation including legislation for the safety of target animals, workers and environment

3554

0.74%

Other legislation

2275

0.47%

Total

481553

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

470469

97.7%

Legislation satisfying national requirements only [within EU]

2083

0.43%

Legislation satisfying Non-EU requirements only

9001

1.87%

Total

481553

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

73520

97.52%

Monoclonal antibody by mouse ascites method

384

0.51%

Other product types

1489

1.97%

Total

75393

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

1793299

98.19%

Yes

32988

1.81%

Total

1826287

100.00%



Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

166236

9.1%

Mild [up to and including]

1040646

56.98%

Moderate

507633

27.8%

Severe

111772

6.12%

Total

1826287

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

1241283

67.97%

Genetically altered without a harmful phenotype

465516

25.49%

Genetically altered with a harmful phenotype

119488

6.54%

Total

1826287

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

117993

432

118425

Rats

3396

3396

Rabbits

17

17

Pigs

61

3

64

Marmoset and tamarins

10

10

Zebra fish

48540

3451

51991

Other Fish

3348

3348

Total

173365

3886

177251

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

11592

6.54%

Mild [up to and including]

143868

81.17%

Moderate

21251

11.99%

Severe

540

0.3%

Total

177251

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

159047

89.73%

Genetically altered with a harmful phenotype

18204

10.27%

Total

177251

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

6057

3.7%

Cardiovascular Blood and Lymphatic System

24671

15.06%

Nervous System

21445

13.09%

Respiratory System

323

0.2%

Gastrointestinal System including Liver

2935

1.79%

Musculoskeletal System

9128

5.57%

Immune System

19540

11.93%

Urogenital/Reproductive System

8775

5.36%

Sensory Organs (skin, eyes and ears)

7414

4.53%

Endocrine System/Metabolism

7078

4.32%

Multisystemic

14782

9.02%

Ethology / Animal Behaviour /Animal Biology

135

0.08%

Other basic research

41521

25.35%

Total

163804

100.00%



Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cancer

1105

8.22%

Human Infectious Disorders

475

3.53%

Human Cardiovascular Disorders

1677

12.47%

Human Nervous and Mental Disorders

1893

14.08%

Human Respiratory Disorders

174

1.29%

Human Gastrointestinal Disorders including Liver

2474

18.4%

Human Musculoskeletal Disorders

13

0.1%

Human Immune Disorders

345

2.57%

Human Urogenital/Reproductive Disorders

171

1.27%

Human Sensory Organ Disorders (skin, eyes and ears)

1009

7.5%

Human Endocrine/Metabolism Disorders

4107

30.54%

Other Human Disorders

4

0.03%

Total

13447

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

61184

129

61313

Rats

1574

1574

Zebra fish

2272

2272

Other Fish

116

116

Total

65146

129

65275

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

267

0.41%

Mild [up to and including]

42476

65.07%

Moderate

19737

30.24%

Severe

2795

4.28%

Total

65275

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

34238

52.45%

Genetically altered with a harmful phenotype

31037

47.55%

Total

65275

100.00%



Member State: Greece, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

21190

50.08%

Rats

2435

5.76%

Guinea-Pigs

6

0.01%

Rabbits

213

0.5%

Dogs

23

0.05%

Pigs

283

0.67%

Sheep

8

0.02%

Cattle

3

0.01%

Domestic fowl

6

0.01%

Zebra fish

1859

4.39%

Other Fish

16250

38.41%

Cephalopods

33

0.08%

Total

42309

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

41636

98.41%

Animals born in the EU but not at a registered breeder

33

0.08%

Animals born in rest of world

640

1.51%

Total

42309

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

21190

329

21519

Rats

2435

3

2438

Guinea-Pigs

6

6

Rabbits

213

213

Cats

8

8

Dogs

23

18

41

Pigs

283

6

289

Sheep

8

8

Cattle

3

3

Rhesus monkey

1

1

Domestic fowl

6

6

Zebra fish

1859

1859

Other Fish

16250

96

16346

Cephalopods

33

33

Total

42309

461

42770

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

23613

55.21%

Translational and applied research

8058

18.84%

Regulatory use and Routine production

6887

16.1%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

3093

7.23%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1119

2.62%

Total

42770

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

923

3.91%

Cardiovascular Blood and Lymphatic System

1315

5.57%

Nervous System

1204

5.1%

Gastrointestinal System including Liver

428

1.81%

Musculoskeletal System

520

2.2%

Immune System

2225

9.42%

Urogenital/Reproductive System

242

1.02%

Sensory Organs (skin, eyes and ears)

988

4.18%

Endocrine System/Metabolism

843

3.57%

Multisystemic

99

0.42%

Ethology / Animal Behaviour /Animal Biology

14686

62.19%

Other basic research

140

0.59%

Total

23613

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

2487

30.86%

Human Infectious Disorders

271

3.36%

Human Cardiovascular Disorders

967

12%

Human Nervous and Mental Disorders

1372

17.03%

Human Respiratory Disorders

291

3.61%

Human Gastrointestinal Disorders including Liver

363

4.5%

Human Musculoskeletal Disorders

710

8.81%

Human Immune Disorders

200

2.48%

Human Sensory Organ Disorders (skin, eyes and ears)

381

4.73%

Human Endocrine/Metabolism Disorders

34

0.42%

Other Human Disorders

648

8.04%

Animal Welfare

40

0.5%

Diagnosis of diseases

230

2.85%

Non-regulatory toxicology and ecotoxicology

64

0.79%

Total

8058

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Toxicity and other safety testing including pharmacology

6887

100%

Total

6887

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Pharmaco-dynamics (incl safety pharmacology)

10

0.15%

Safety testing in food and feed area

6877

99.85%

Total

6887

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

10

0.15%

Food legislation including food contact material

6877

99.85%

Total

6887

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

6887

100%

Total

6887

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

42309

98.92%

Yes

461

1.08%

Total

42770

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

3646

8.52%

Mild [up to and including]

25432

59.46%

Moderate

9198

21.51%

Severe

4494

10.51%

Total

42770

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

31622

73.94%

Genetically altered without a harmful phenotype

9022

21.09%

Genetically altered with a harmful phenotype

2126

4.97%

Total

42770

100.00%

Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

3960

3960

Total

3960

3960

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

3960

100%

Total

3960

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

3960

100%

Total

3960

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Other basic research

3960

100%

Total

3960

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Member State: Hungary, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

65368

49.18%

Rats

33255

25.02%

Guinea-Pigs

5731

4.31%

Rabbits

1343

1.01%

Cats

16

0.01%

Dogs

359

0.27%

Ferrets

4

0%

Pigs

2078

1.56%

Cattle

12

0.01%

Rhesus monkey

2

0%

Domestic fowl

20575

15.48%

Other birds

2084

1.57%

Zebra fish

928

0.7%

Other Fish

1174

0.88%

Total

132929

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

126369

95.07%

Animals born in the EU but not at a registered breeder

5062

3.81%

Animals born in rest of Europe

1187

0.89%

Animals born in rest of world

309

0.23%

Total

132927

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

2

100%

Total

2

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F2 or greater

2

100%

Total

2

100.00%



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

65368

346

65714

Rats

33255

691

33946

Guinea-Pigs

5731

34

5765

Rabbits

1343

88

1431

Cats

16

16

Dogs

359

104

463

Ferrets

4

4

Pigs

2078

327

2405

Cattle

12

21

33

Rhesus monkey

2

2

Domestic fowl

20575

4594

25169

Other birds

2084

2084

Zebra fish

928

748

1676

Other Fish

1174

1174

Total

132929

6953

139882

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

37658

26.92%

Translational and applied research

41847

29.92%

Regulatory use and Routine production

58007

41.47%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

2370

1.69%

Total

139882

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

3346

8.89%

Cardiovascular Blood and Lymphatic System

3342

8.87%

Nervous System

16376

43.49%

Respiratory System

718

1.91%

Gastrointestinal System including Liver

1865

4.95%

Musculoskeletal System

189

0.5%

Immune System

4412

11.72%

Urogenital/Reproductive System

1678

4.46%

Sensory Organs (skin, eyes and ears)

488

1.3%

Endocrine System/Metabolism

1417

3.76%

Multisystemic

1802

4.79%

Ethology / Animal Behaviour /Animal Biology

526

1.4%

Other basic research

1499

3.98%

Total

37658

100.00%



Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

4919

11.75%

Human Infectious Disorders

581

1.39%

Human Cardiovascular Disorders

293

0.7%

Human Nervous and Mental Disorders

20172

48.2%

Human Gastrointestinal Disorders including Liver

211

0.5%

Human Musculoskeletal Disorders

79

0.19%

Human Immune Disorders

89

0.21%

Human Urogenital/Reproductive Disorders

8

0.02%

Human Sensory Organ Disorders (skin, eyes and ears)

40

0.1%

Other Human Disorders

224

0.54%

Animal Diseases and Disorders

9410

22.49%

Animal Welfare

4573

10.93%

Diagnosis of diseases

788

1.88%

Non-regulatory toxicology and ecotoxicology

460

1.1%

Total

41847

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

27156

46.82%

Other efficacy and tolerance testing

329

0.57%

Toxicity and other safety testing including pharmacology

29813

51.4%

Routine production

709

1.22%

Total

58007

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

10102

37.2%

Pyrogenicity testing

29

0.11%

Batch potency testing

16682

61.43%

Other quality controls

343

1.26%

Total

27156

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

17639

59.17%

Skin irritation/corrosion

293

0.98%

Skin sensitisation

4629

15.53%

Eye irritation/corrosion

137

0.46%

Repeated dose toxicity

1125

3.77%

Carcinogenicity

40

0.13%

Genotoxicity

562

1.89%

Reproductive toxicity

833

2.79%

Developmental toxicity

1286

4.31%

Kinetics

1207

4.05%

Pharmaco-dynamics (incl safety pharmacology)

569

1.91%

Ecotoxicity

1028

3.45%

Other toxicity/safety testing

465

1.56%

Total

29813

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

14255

80.82%

Non lethal methods

3384

19.18%

Total

17639

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

438

38.93%

29 - 90 days

75

6.67%

> 90 days

612

54.4%

Total

1125

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

1028

100%

Total

1028

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

24550

42.85%

Legislation on medicinal products for veterinary use and their residues

28770

50.21%

Medical devices legislation

516

0.9%

Industrial chemicals legislation

834

1.46%

Plant protection product legislation

2167

3.78%

Food legislation including food contact material

461

0.8%

Total

57298

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

56022

97.77%

Legislation satisfying Non-EU requirements only

1276

2.23%

Total

57298

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

40

5.64%

Monoclonal antibody by mouse ascites method

157

22.14%

Other product types

512

72.21%

Total

709

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

132929

95.03%

Yes

6953

4.97%

Total

139882

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

12314

8.8%

Mild [up to and including]

69792

49.89%

Moderate

39760

28.42%

Severe

18016

12.88%

Total

139882

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

131890

94.29%

Genetically altered without a harmful phenotype

7386

5.28%

Genetically altered with a harmful phenotype

606

0.43%

Total

139882

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

162

162

Rabbits

152

152

Zebra fish

567

567

Total

314

567

881

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

96

10.9%

Mild [up to and including]

591

67.08%

Moderate

194

22.02%

Total

881

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

339

38.48%

Genetically altered without a harmful phenotype

512

58.12%

Genetically altered with a harmful phenotype

30

3.41%

Total

881

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Cardiovascular Blood and Lymphatic System

64

7.26%

Nervous System

122

13.85%

Multisystemic

567

64.36%

Other basic research

128

14.53%

Total

881

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Member State: Ireland, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

205849

85.57%

Rats

16858

7.01%

Guinea-Pigs

518

0.22%

Rabbits

400

0.17%

Dogs

46

0.02%

Ferrets

442

0.18%

Horses, donkeys and cross-breeds

59

0.02%

Pigs

1519

0.63%

Goats

11

0%

Sheep

1189

0.49%

Cattle

2805

1.17%

Domestic fowl

40

0.02%

Other birds

823

0.34%

Xenopus

18

0.01%

Zebra fish

236

0.1%

Other Fish

9755

4.05%

Total

240568

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

226935

94.33%

Animals born in the EU but not at a registered breeder

13065

5.43%

Animals born in rest of Europe

121

0.05%

Animals born in rest of world

447

0.19%

Total

240568

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

205849

205849

Rats

16858

16858

Guinea-Pigs

518

518

Rabbits

400

400

Dogs

46

43

89

Ferrets

442

442

Horses, donkeys and cross-breeds

59

1

60

Pigs

1519

28

1547

Goats

11

11

Sheep

1189

132

1321

Cattle

2805

439

3244

Domestic fowl

40

40

Other birds

823

823

Xenopus

18

18

Zebra fish

236

236

Other Fish

9755

32

9787

Total

240568

675

241243

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

8492

3.52%

Translational and applied research

29295

12.14%

Regulatory use and Routine production

194816

80.76%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

8366

3.47%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

274

0.11%

Total

241243

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

391

4.6%

Cardiovascular Blood and Lymphatic System

5

0.06%

Nervous System

2068

24.35%

Respiratory System

658

7.75%

Gastrointestinal System including Liver

1111

13.08%

Musculoskeletal System

192

2.26%

Immune System

991

11.67%

Urogenital/Reproductive System

238

2.8%

Sensory Organs (skin, eyes and ears)

54

0.64%

Endocrine System/Metabolism

139

1.64%

Multisystemic

6

0.07%

Ethology / Animal Behaviour /Animal Biology

2635

31.03%

Other basic research

4

0.05%

Total

8492

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

754

2.57%

Human Infectious Disorders

780

2.66%

Human Cardiovascular Disorders

1129

3.85%

Human Nervous and Mental Disorders

9381

32.02%

Human Respiratory Disorders

277

0.95%

Human Gastrointestinal Disorders including Liver

1114

3.8%

Human Musculoskeletal Disorders

734

2.51%

Human Immune Disorders

7789

26.59%

Human Urogenital/Reproductive Disorders

50

0.17%

Human Sensory Organ Disorders (skin, eyes and ears)

2057

7.02%

Human Endocrine/Metabolism Disorders

444

1.52%

Animal Diseases and Disorders

2115

7.22%

Animal Welfare

2553

8.71%

Diagnosis of diseases

118

0.4%

Total

29295

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

194247

99.71%

Toxicity and other safety testing including pharmacology

540

0.28%

Routine production

29

0.01%

Total

194816

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1920

0.99%

Pyrogenicity testing

312

0.16%

Batch potency testing

192015

98.85%

Total

194247

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Ecotoxicity

500

92.59%

Target animal safety

40

7.41%

Total

540

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported



Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

500

100%

Total

500

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

185698

95.33%

Legislation on medicinal products for veterinary use and their residues

8589

4.41%

Other legislation

500

0.26%

Total

194787

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

194755

99.98%

Legislation satisfying national requirements only [within EU]

32

0.02%

Total

194787

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

29

100%

Total

29

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

240568

99.72%

Yes

675

0.28%

Total

241243

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

2283

0.95%

Mild [up to and including]

113244

46.94%

Moderate

55158

22.86%

Severe

70558

29.25%

Total

241243

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

234363

97.15%

Genetically altered without a harmful phenotype

5121

2.12%

Genetically altered with a harmful phenotype

1759

0.73%

Total

241243

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

586

586

Total

586

586

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

548

93.52%

Severe

38

6.48%

Total

586

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

586

100%

Total

586

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Respiratory System

66

100%

Total

66

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cardiovascular Disorders

66

12.69%

Human Musculoskeletal Disorders

13

2.5%

Human Immune Disorders

441

84.81%

Total

520

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

473

473

Total

473

473

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

469

99.15%

Moderate

4

0.85%

Total

473

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

443

93.66%

Genetically altered without a harmful phenotype

30

6.34%

Total

473

100.00%

Member State: Italy, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

347361

61.54%

Rats

117203

20.76%

Guinea-Pigs

14246

2.52%

Hamsters (Syrian)

277

0.05%

Other Rodents

647

0.11%

Rabbits

18146

3.21%

Dogs

373

0.07%

Ferrets

42

0.01%

Pigs

1559

0.28%

Sheep

120

0.02%

Cattle

270

0.05%

Cynomolgus monkey

545

0.1%

Rhesus monkey

3

0%

Other Mammals

24

0%

Domestic fowl

33358

5.91%

Other birds

420

0.07%

Xenopus

371

0.07%

Zebra fish

19415

3.44%

Other Fish

10079

1.79%

Cephalopods

10

0%

Total

564469

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

497349

88.19%

Animals born in the EU but not at a registered breeder

64411

11.42%

Animals born in rest of Europe

840

0.15%

Animals born in rest of world

1321

0.23%

Total

563921

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

1

0.18%

Animals born in Asia

57

10.4%

Animals born in Africa

490

89.42%

Total

548

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F1

137

25%

F2 or greater

411

75%

Total

548

100.00%

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

347361

483

347844

Rats

117203

338

117541

Guinea-Pigs

14246

111

14357

Hamsters (Syrian)

277

277

Other Rodents

647

647

Rabbits

18146

1179

19325

Dogs

373

266

639

Ferrets

42

42

Horses, donkeys and cross-breeds

17

17

Pigs

1559

62

1621

Goats

23

23

Sheep

120

72

192

Cattle

270

9

279

Marmoset and tamarins

1

1

Cynomolgus monkey

545

24

569

Rhesus monkey

3

1

4

Other Mammals

24

6

30

Domestic fowl

33358

1357

34715

Other birds

420

420

Xenopus

371

30

401

Zebra fish

19415

93

19508

Other Fish

10079

636

10715

Cephalopods

10

10

Total

564469

4708

569177

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

187054

32.86%

Translational and applied research

152986

26.88%

Regulatory use and Routine production

225842

39.68%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

1697

0.3%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1598

0.28%

Total

569177

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

57091

30.52%

Cardiovascular Blood and Lymphatic System

8534

4.56%

Nervous System

69030

36.9%

Respiratory System

1384

0.74%

Gastrointestinal System including Liver

5792

3.1%

Musculoskeletal System

6922

3.7%

Immune System

13588

7.26%

Urogenital/Reproductive System

2830

1.51%

Sensory Organs (skin, eyes and ears)

3892

2.08%

Endocrine System/Metabolism

4459

2.38%

Multisystemic

3513

1.88%

Ethology / Animal Behaviour /Animal Biology

5028

2.69%

Other basic research

4991

2.67%

Total

187054

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

46470

30.38%

Human Infectious Disorders

21902

14.32%

Human Cardiovascular Disorders

1844

1.21%

Human Nervous and Mental Disorders

18352

12%

Human Respiratory Disorders

16658

10.89%

Human Gastrointestinal Disorders including Liver

2644

1.73%

Human Musculoskeletal Disorders

5955

3.89%

Human Immune Disorders

3734

2.44%

Human Urogenital/Reproductive Disorders

2989

1.95%

Human Sensory Organ Disorders (skin, eyes and ears)

2447

1.6%

Human Endocrine/Metabolism Disorders

3064

2%

Other Human Disorders

4953

3.24%

Animal Diseases and Disorders

7228

4.72%

Animal Welfare

918

0.6%

Diagnosis of diseases

13483

8.81%

Non-regulatory toxicology and ecotoxicology

345

0.23%

Total

152986

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

111851

49.53%

Other efficacy and tolerance testing

45856

20.3%

Toxicity and other safety testing including pharmacology

63786

28.24%

Routine production

4349

1.93%

Total

225842

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

21535

19.25%

Pyrogenicity testing

2717

2.43%

Batch potency testing

84520

75.56%

Other quality controls

3079

2.75%

Total

111851

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

10612

16.64%

Skin irritation/corrosion

820

1.29%

Skin sensitisation

11983

18.79%

Eye irritation/corrosion

93

0.15%

Repeated dose toxicity

8757

13.73%

Genotoxicity

291

0.46%

Reproductive toxicity

628

0.98%

Developmental toxicity

5554

8.71%

Neurotoxicity

300

0.47%

Kinetics

5976

9.37%

Pharmaco-dynamics (incl safety pharmacology)

1154

1.81%

Ecotoxicity

4224

6.62%

Safety testing in food and feed area

10807

16.94%

Target animal safety

1212

1.9%

Other toxicity/safety testing

1375

2.16%

Total

63786

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

1211

11.41%

Other lethal methods

755

7.11%

Non lethal methods

8646

81.47%

Total

10612

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

4157

47.47%

29 - 90 days

2782

31.77%

> 90 days

1818

20.76%

Total

8757

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3930

93.04%

Other ecotoxicity

294

6.96%

Total

4224

100.00%



Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

143853

64.95%

Legislation on medicinal products for veterinary use and their residues

35700

16.12%

Medical devices legislation

16869

7.62%

Industrial chemicals legislation

8715

3.93%

Plant protection product legislation

595

0.27%

Biocides legislation

624

0.28%

Food legislation including food contact material

11492

5.19%

Feed legislation including legislation for the safety of target animals, workers and environment

1074

0.48%

Other legislation

2571

1.16%

Total

221493

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

204920

92.52%

Legislation satisfying national requirements only [within EU]

3268

1.48%

Legislation satisfying Non-EU requirements only

13305

6.01%

Total

221493

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

2861

65.79%

Other product types

1488

34.21%

Total

4349

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

564469

99.17%

Yes

4708

0.83%

Total

569177

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

29618

5.2%

Mild [up to and including]

275143

48.34%

Moderate

175666

30.86%

Severe

88750

15.59%

Total

569177

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

448298

78.76%

Genetically altered without a harmful phenotype

103778

18.23%

Genetically altered with a harmful phenotype

17101

3%

Total

569177

100.00%

Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

7799

7799

Rats

510

510

Pigs

36

36

Total

8345

8345

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

2257

27.05%

Mild [up to and including]

3751

44.95%

Moderate

1470

17.62%

Severe

867

10.39%

Total

8345

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

399

4.78%

Genetically altered without a harmful phenotype

7598

91.05%

Genetically altered with a harmful phenotype

348

4.17%

Total

8345

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

1422

18.74%

Cardiovascular Blood and Lymphatic System

101

1.33%

Nervous System

5313

70.02%

Musculoskeletal System

11

0.14%

Immune System

79

1.04%

Endocrine System/Metabolism

317

4.18%

Multisystemic

345

4.55%

Total

7588

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cardiovascular Disorders

8

1.06%

Human Nervous and Mental Disorders

146

19.29%

Human Gastrointestinal Disorders including Liver

62

8.19%

Human Musculoskeletal Disorders

52

6.87%

Human Immune Disorders

141

18.63%

Human Urogenital/Reproductive Disorders

3

0.4%

Human Sensory Organ Disorders (skin, eyes and ears)

10

1.32%

Other Human Disorders

335

44.25%

Total

757

100.00%



All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

2485

2485

Rats

53

53

Total

2538

2538

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

2175

85.7%

Moderate

44

1.73%

Severe

319

12.57%

Total

2538

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

1498

59.02%

Genetically altered with a harmful phenotype

1040

40.98%

Total

2538

100.00%



Member State: Latvia, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

3332

63%

Rats

1795

33.94%

Pigs

22

0.42%

Other Mammals

140

2.65%

Total

5289

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

5127

96.94%

Animals born in the EU but not at a registered breeder

162

3.06%

Total

5289

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

3332

3332

Rats

1795

1795

Pigs

22

22

Other Mammals

140

140

Total

5289

5289

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

1724

32.6%

Translational and applied research

3543

66.99%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

22

0.42%

Total

5289

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

4

0.23%

Nervous System

1580

91.65%

Ethology / Animal Behaviour /Animal Biology

140

8.12%

Total

1724

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

840

23.71%

Human Infectious Disorders

135

3.81%

Human Cardiovascular Disorders

1406

39.68%

Human Nervous and Mental Disorders

605

17.08%

Human Urogenital/Reproductive Disorders

70

1.98%

Human Endocrine/Metabolism Disorders

0

0%

Animal Diseases and Disorders

377

10.64%

Non-regulatory toxicology and ecotoxicology

110

3.1%

Total

3543

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

No data reported

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported



Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

No data reported

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

No data reported

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

5289

100%

Total

5289

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

1372

25.94%

Mild [up to and including]

2050

38.76%

Moderate

1701

32.16%

Severe

166

3.14%

Total

5289

100.00%



Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

5229

98.87%

Genetically altered without a harmful phenotype

60

1.13%

Total

5289

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

No data reported

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported



Member State: Lithuania, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

1718

62.11%

Rats

391

14.14%

Guinea-Pigs

15

0.54%

Rabbits

13

0.47%

Pigs

68

2.46%

Sheep

15

0.54%

Other birds

26

0.94%

Other Fish

520

18.8%

Total

2766

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

2683

97%

Animals born in the EU but not at a registered breeder

83

3%

Total

2766

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

1718

1718

Rats

391

391

Guinea-Pigs

15

15

Rabbits

13

13

Pigs

68

68

Sheep

15

15

Other birds

26

26

Other Fish

520

520

Total

2766

2766

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

1659

59.98%

Translational and applied research

501

18.11%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

606

21.91%

Total

2766

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

337

20.31%

Cardiovascular Blood and Lymphatic System

20

1.21%

Nervous System

284

17.12%

Respiratory System

103

6.21%

Musculoskeletal System

10

0.6%

Immune System

873

52.62%

Multisystemic

32

1.93%

Total

1659

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Infectious Disorders

102

20.36%

Human Cardiovascular Disorders

8

1.6%

Human Nervous and Mental Disorders

107

21.36%

Human Sensory Organ Disorders (skin, eyes and ears)

17

3.39%

Non-regulatory toxicology and ecotoxicology

267

53.29%

Total

501

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

No data reported

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

No data reported

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

No data reported

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

2766

100%

Total

2766

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

83

3%

Mild [up to and including]

2186

79.03%

Moderate

497

17.97%

Total

2766

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

2766

100%

Total

2766

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

No data reported

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported



Member State: Luxembourg, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

5348

21.14%

Rats

96

0.38%

Zebra fish

19849

78.48%

Total

25293

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

25293

100%

Total

25293

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

5348

224

5572

Rats

96

96

Zebra fish

19849

19849

Total

25293

224

25517

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

24485

95.96%

Translational and applied research

888

3.48%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

144

0.56%

Total

25517

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

1861

7.6%

Cardiovascular Blood and Lymphatic System

374

1.53%

Nervous System

20188

82.45%

Immune System

2062

8.42%

Total

24485

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

526

59.23%

Human Infectious Disorders

326

36.71%

Human Immune Disorders

36

4.05%

Total

888

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

No data reported

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

No data reported

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

No data reported

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

25293

99.12%

Yes

224

0.88%

Total

25517

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

519

2.03%

Mild [up to and including]

21614

84.7%

Moderate

3213

12.59%

Severe

171

0.67%

Total

25517

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

22113

86.66%

Genetically altered without a harmful phenotype

3336

13.07%

Genetically altered with a harmful phenotype

68

0.27%

Total

25517

100.00%

Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Zebra fish

77

77

Total

77

77

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

77

100%

Total

77

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

77

100%

Total

77

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Nervous System

77

100%

Total

77

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Zebra fish

247

247

Total

247

247

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

247

100%

Total

247

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

247

100%

Total

247

100.00%

Member State: Malta, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Other Fish

250

100%

Total

250

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in rest of Europe

250

100%

Total

250

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Other Fish

250

250

Total

250

250

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Translational and applied research

250

100%

Total

250

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

No data reported

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Animal Diseases and Disorders

250

100%

Total

250

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

No data reported

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported



Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

No data reported

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

No data reported

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

250

100%

Total

250

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Mild [up to and including]

250

100%

Total

250

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

250

100%

Total

250

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

No data reported

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported



Member State: Netherlands, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

188238

41.48%

Rats

89294

19.68%

Guinea-Pigs

5702

1.26%

Hamsters (Syrian)

1025

0.23%

Hamsters (Chinese)

12

0%

Other Rodents

736

0.16%

Rabbits

9551

2.1%

Cats

174

0.04%

Dogs

549

0.12%

Ferrets

608

0.13%

Other carnivores

270

0.06%

Horses, donkeys and cross-breeds

173

0.04%

Pigs

9587

2.11%

Goats

176

0.04%

Sheep

531

0.12%

Cattle

2629

0.58%

Marmoset and tamarins

27

0.01%

Cynomolgus monkey

23

0.01%

Rhesus monkey

141

0.03%

Other Mammals

3305

0.73%

Domestic fowl

55152

12.15%

Other birds

17946

3.95%

Reptiles

294

0.06%

Xenopus

278

0.06%

Other Amphibians

60

0.01%

Zebra fish

51456

11.34%

Other Fish

15842

3.49%

Total

453779

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

350508

77.27%

Animals born in the EU but not at a registered breeder

94773

20.89%

Animals born in rest of Europe

44

0.01%

Animals born in rest of world

8263

1.82%

Total

453588

100.00%



Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

189

98.95%

Animals born in Asia

2

1.05%

Total

191

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F2 or greater

2

1.05%

Self-sustaining colony

189

98.95%

Total

191

100.00%



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

188238

5906

194144

Rats

89294

1805

91099

Guinea-Pigs

5702

114

5816

Hamsters (Syrian)

1025

10

1035

Hamsters (Chinese)

12

12

Other Rodents

736

736

Rabbits

9551

213

9764

Cats

174

26

200

Dogs

549

360

909

Ferrets

608

72

680

Other carnivores

270

270

Horses, donkeys and cross-breeds

173

173

Pigs

9587

151

9738

Goats

176

83

259

Sheep

531

27

558

Cattle

2629

1204

3833

Marmoset and tamarins

27

14

41

Cynomolgus monkey

23

19

42

Rhesus monkey

141

93

234

Other Mammals

3305

10

3315

Domestic fowl

55152

219

55371

Other birds

17946

376

18322

Reptiles

294

294

Rana

9

9

Xenopus

278

160

438

Other Amphibians

60

60

Zebra fish

51456

220

51676

Other Fish

15842

45

15887

Total

453779

11136

464915

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

188633

40.57%

Translational and applied research

127029

27.32%

Regulatory use and Routine production

122247

26.29%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

873

0.19%

Preservation of species

3698

0.8%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

22074

4.75%

Forensic enquiries

361

0.08%

Total

464915

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

86830

46.03%

Cardiovascular Blood and Lymphatic System

6673

3.54%

Nervous System

17654

9.36%

Respiratory System

758

0.4%

Gastrointestinal System including Liver

2857

1.51%

Musculoskeletal System

692

0.37%

Immune System

16286

8.63%

Urogenital/Reproductive System

1129

0.6%

Sensory Organs (skin, eyes and ears)

1030

0.55%

Endocrine System/Metabolism

4351

2.31%

Multisystemic

4084

2.17%

Ethology / Animal Behaviour /Animal Biology

20617

10.93%

Other basic research

25672

13.61%

Total

188633

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

13914

10.95%

Human Infectious Disorders

22898

18.03%

Human Cardiovascular Disorders

5882

4.63%

Human Nervous and Mental Disorders

9358

7.37%

Human Respiratory Disorders

2410

1.9%

Human Gastrointestinal Disorders including Liver

2554

2.01%

Human Musculoskeletal Disorders

1587

1.25%

Human Immune Disorders

4179

3.29%

Human Urogenital/Reproductive Disorders

814

0.64%

Human Sensory Organ Disorders (skin, eyes and ears)

575

0.45%

Human Endocrine/Metabolism Disorders

2423

1.91%

Other Human Disorders

235

0.18%

Animal Diseases and Disorders

31368

24.69%

Animal Welfare

22221

17.49%

Diagnosis of diseases

1115

0.88%

Plant diseases

8

0.01%

Non-regulatory toxicology and ecotoxicology

5488

4.32%

Total

127029

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

50082

40.97%

Other efficacy and tolerance testing

3235

2.65%

Toxicity and other safety testing including pharmacology

68753

56.24%

Routine production

177

0.14%

Total

122247

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

1948

3.89%

Batch potency testing

47934

95.71%

Other quality controls

200

0.4%

Total

50082

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1886

2.74%

Skin irritation/corrosion

47

0.07%

Skin sensitisation

2378

3.46%

Eye irritation/corrosion

59

0.09%

Repeated dose toxicity

8739

12.71%

Genotoxicity

106

0.15%

Reproductive toxicity

36568

53.19%

Developmental toxicity

9944

14.46%

Kinetics

1635

2.38%

Pharmaco-dynamics (incl safety pharmacology)

8

0.01%

Phototoxicity

4

0.01%

Ecotoxicity

4101

5.96%

Safety testing in food and feed area

2104

3.06%

Target animal safety

1174

1.71%

Total

68753

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

Non lethal methods

1886

100%

Total

1886

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

3875

44.34%

29 - 90 days

4131

47.27%

> 90 days

733

8.39%

Total

8739

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

1368

33.36%

Chronic toxicity

2329

56.79%

Bioaccumulation

404

9.85%

Total

4101

100.00%



Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

30050

24.62%

Legislation on medicinal products for veterinary use and their residues

31915

26.14%

Industrial chemicals legislation

57024

46.71%

Plant protection product legislation

312

0.26%

Biocides legislation

92

0.08%

Food legislation including food contact material

447

0.37%

Feed legislation including legislation for the safety of target animals, workers and environment

2164

1.77%

Other legislation

66

0.05%

Total

122070

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

119368

97.79%

Legislation satisfying national requirements only [within EU]

8

0.01%

Legislation satisfying Non-EU requirements only

2694

2.21%

Total

122070

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

6

3.39%

Other product types

171

96.61%

Total

177

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

453779

97.6%

Yes

11136

2.4%

Total

464915

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

31581

6.79%

Mild [up to and including]

298851

64.28%

Moderate

120316

25.88%

Severe

14167

3.05%

Total

464915

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

335918

72.25%

Genetically altered without a harmful phenotype

121284

26.09%

Genetically altered with a harmful phenotype

7713

1.66%

Total

464915

100.00%

Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

10790

2

10792

Rats

9

9

Zebra fish

167

167

Total

10966

2

10968

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

30

0.27%

Mild [up to and including]

10045

91.58%

Moderate

879

8.01%

Severe

14

0.13%

Total

10968

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

8267

75.37%

Genetically altered without a harmful phenotype

2655

24.21%

Genetically altered with a harmful phenotype

46

0.42%

Total

10968

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

7630

71.9%

Cardiovascular Blood and Lymphatic System

195

1.84%

Nervous System

521

4.91%

Gastrointestinal System including Liver

346

3.26%

Immune System

296

2.79%

Urogenital/Reproductive System

70

0.66%

Multisystemic

31

0.29%

Other basic research

1523

14.35%

Total

10612

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cancer

6

1.69%

Human Infectious Disorders

15

4.21%

Human Nervous and Mental Disorders

334

93.82%

Human Gastrointestinal Disorders including Liver

1

0.28%

Total

356

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

1057

1057

Rats

429

429

Zebra fish

181

181

Total

1667

1667

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

1106

66.35%

Moderate

544

32.63%

Severe

17

1.02%

Total

1667

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered with a harmful phenotype

1667

100%

Total

1667

100.00%



Member State: Poland, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

88894

57.51%

Rats

28865

18.67%

Guinea-Pigs

5232

3.38%

Hamsters (Syrian)

150

0.1%

Mongolian gerbil

120

0.08%

Other Rodents

7930

5.13%

Rabbits

718

0.46%

Other carnivores

130

0.08%

Horses, donkeys and cross-breeds

50

0.03%

Pigs

1513

0.98%

Goats

17

0.01%

Sheep

1231

0.8%

Cattle

403

0.26%

Other species of Old World Monkeys (Cercopithecoidea)

14

0.01%

Other species of New World Monkeys (Ceboidea)

3

0%

Other Mammals

639

0.41%

Domestic fowl

5067

3.28%

Other birds

6470

4.19%

Reptiles

314

0.2%

Rana

20

0.01%

Other Amphibians

456

0.3%

Zebra fish

950

0.61%

Other Fish

5381

3.48%

Total

154567

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

135019

87.36%

Animals born in the EU but not at a registered breeder

18496

11.97%

Animals born in rest of Europe

361

0.23%

Animals born in rest of world

674

0.44%

Total

154550

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

17

100%

Total

17

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F2 or greater

17

100%

Total

17

100.00%

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

88894

297

89191

Rats

28865

8

28873

Guinea-Pigs

5232

3

5235

Hamsters (Syrian)

150

150

Mongolian gerbil

120

120

Other Rodents

7930

178

8108

Rabbits

718

102

820

Dogs

10

10

Other carnivores

130

130

Horses, donkeys and cross-breeds

50

23

73

Pigs

1513

4

1517

Goats

17

7

24

Sheep

1231

70

1301

Cattle

403

10

413

Other species of Old World Monkeys (Cercopithecoidea)

14

14

Other species of New World Monkeys (Ceboidea)

3

3

Other Mammals

639

639

Domestic fowl

5067

5067

Other birds

6470

96

6566

Reptiles

314

314

Rana

20

20

Other Amphibians

456

456

Zebra fish

950

950

Other Fish

5381

5381

Total

154567

808

155375

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

113469

73.03%

Translational and applied research

15947

10.26%

Regulatory use and Routine production

24762

15.94%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

43

0.03%

Preservation of species

25

0.02%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1129

0.73%

Total

155375

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

8173

7.2%

Cardiovascular Blood and Lymphatic System

6727

5.93%

Nervous System

52378

46.16%

Respiratory System

784

0.69%

Gastrointestinal System including Liver

3070

2.71%

Musculoskeletal System

673

0.59%

Immune System

7755

6.83%

Urogenital/Reproductive System

2929

2.58%

Sensory Organs (skin, eyes and ears)

225

0.2%

Endocrine System/Metabolism

5992

5.28%

Multisystemic

5956

5.25%

Ethology / Animal Behaviour /Animal Biology

10531

9.28%

Other basic research

8276

7.29%

Total

113469

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

3081

19.32%

Human Infectious Disorders

366

2.3%

Human Cardiovascular Disorders

815

5.11%

Human Nervous and Mental Disorders

1176

7.37%

Human Respiratory Disorders

943

5.91%

Human Musculoskeletal Disorders

64

0.4%

Human Immune Disorders

120

0.75%

Human Urogenital/Reproductive Disorders

44

0.28%

Human Sensory Organ Disorders (skin, eyes and ears)

20

0.13%

Human Endocrine/Metabolism Disorders

316

1.98%

Other Human Disorders

35

0.22%

Animal Diseases and Disorders

490

3.07%

Animal Welfare

3852

24.16%

Diagnosis of diseases

3088

19.36%

Non-regulatory toxicology and ecotoxicology

1537

9.64%

Total

15947

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

16493

66.61%

Other efficacy and tolerance testing

195

0.79%

Toxicity and other safety testing including pharmacology

7784

31.44%

Routine production

290

1.17%

Total

24762

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

3982

24.14%

Pyrogenicity testing

236

1.43%

Batch potency testing

11482

69.62%

Other quality controls

793

4.81%

Total

16493

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

1050

13.49%

Skin irritation/corrosion

139

1.79%

Skin sensitisation

707

9.08%

Eye irritation/corrosion

9

0.12%

Repeated dose toxicity

807

10.37%

Reproductive toxicity

669

8.59%

Developmental toxicity

1694

21.76%

Kinetics

30

0.39%

Ecotoxicity

2364

30.37%

Other toxicity/safety testing

315

4.05%

Total

7784

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

180

17.14%

Non lethal methods

870

82.86%

Total

1050

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

387

47.96%

29 - 90 days

420

52.04%

Total

807

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

2364

100%

Total

2364

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

16253

66.41%

Legislation on medicinal products for veterinary use and their residues

2251

9.2%

Medical devices legislation

896

3.66%

Industrial chemicals legislation

2652

10.84%

Plant protection product legislation

2276

9.3%

Biocides legislation

24

0.1%

Food legislation including food contact material

120

0.49%

Total

24472

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

23931

97.79%

Legislation satisfying national requirements only [within EU]

514

2.1%

Legislation satisfying Non-EU requirements only

27

0.11%

Total

24472

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Other product types

290

100%

Total

290

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

154567

99.48%

Yes

808

0.52%

Total

155375

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

4757

3.06%

Mild [up to and including]

49725

32%

Moderate

49829

32.07%

Severe

51064

32.87%

Total

155375

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

146889

94.54%

Genetically altered without a harmful phenotype

5547

3.57%

Genetically altered with a harmful phenotype

2939

1.89%

Total

155375

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

188

188

Rats

109

109

Other Mammals

61

61

Total

358

358

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

34

9.5%

Mild [up to and including]

34

9.5%

Moderate

184

51.4%

Severe

106

29.61%

Total

358

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered without a harmful phenotype

358

100%

Total

358

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Nervous System

170

100%

Total

170

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Animal Diseases and Disorders

188

100%

Total

188

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

501

501

Total

501

501

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

501

100%

Total

501

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Genetically altered with a harmful phenotype

501

100%

Total

501

100.00%

Member State: Portugal, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

35221

85.91%

Rats

3133

7.64%

Other Rodents

140

0.34%

Rabbits

36

0.09%

Pigs

155

0.38%

Sheep

12

0.03%

Other Mammals

32

0.08%

Domestic fowl

120

0.29%

Zebra fish

906

2.21%

Other Fish

793

1.93%

Cephalopods

450

1.1%

Total

40998

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

39214

95.65%

Animals born in the EU but not at a registered breeder

1455

3.55%

Animals born in rest of world

329

0.8%

Total

40998

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

35221

905

36126

Rats

3133

2

3135

Other Rodents

140

140

Rabbits

36

36

Pigs

155

155

Sheep

12

18

30

Other Mammals

32

32

Domestic fowl

120

120

Other birds

56

56

Zebra fish

906

6

912

Other Fish

793

36

829

Cephalopods

450

450

Total

40998

1023

42021

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

36214

86.18%

Translational and applied research

5117

12.18%

Regulatory use and Routine production

298

0.71%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

392

0.93%

Total

42021

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

3147

8.69%

Cardiovascular Blood and Lymphatic System

1202

3.32%

Nervous System

4877

13.47%

Respiratory System

83

0.23%

Gastrointestinal System including Liver

683

1.89%

Musculoskeletal System

173

0.48%

Immune System

20680

57.1%

Urogenital/Reproductive System

36

0.1%

Endocrine System/Metabolism

1437

3.97%

Multisystemic

153

0.42%

Ethology / Animal Behaviour /Animal Biology

1277

3.53%

Other basic research

2466

6.81%

Total

36214

100.00%



Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

162

3.17%

Human Infectious Disorders

403

7.88%

Human Cardiovascular Disorders

68

1.33%

Human Nervous and Mental Disorders

1973

38.56%

Human Gastrointestinal Disorders including Liver

102

1.99%

Human Musculoskeletal Disorders

127

2.48%

Human Sensory Organ Disorders (skin, eyes and ears)

233

4.55%

Human Endocrine/Metabolism Disorders

36

0.7%

Animal Diseases and Disorders

3

0.06%

Animal Welfare

604

11.8%

Diagnosis of diseases

914

17.86%

Non-regulatory toxicology and ecotoxicology

492

9.62%

Total

5117

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Toxicity and other safety testing including pharmacology

298

100%

Total

298

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Ecotoxicity

126

42.28%

Safety testing in food and feed area

172

57.72%

Total

298

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Chronic toxicity

126

100%

Total

126

100.00%



Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for veterinary use and their residues

126

42.28%

Food legislation including food contact material

172

57.72%

Total

298

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

298

100%

Total

298

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

40998

97.57%

Yes

1023

2.43%

Total

42021

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

2017

4.8%

Mild [up to and including]

17515

41.68%

Moderate

12114

28.83%

Severe

10375

24.69%

Total

42021

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

27193

64.71%

Genetically altered without a harmful phenotype

13750

32.72%

Genetically altered with a harmful phenotype

1078

2.57%

Total

42021

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

495

39

534

Total

495

39

534

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

256

47.94%

Moderate

237

44.38%

Severe

41

7.68%

Total

534

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

17

3.18%

Genetically altered without a harmful phenotype

502

94.01%

Genetically altered with a harmful phenotype

15

2.81%

Total

534

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

83

18.49%

Cardiovascular Blood and Lymphatic System

3

0.67%

Nervous System

75

16.7%

Immune System

288

64.14%

Total

449

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Nervous and Mental Disorders

85

100%

Total

85

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

9447

9447

Zebra fish

368

368

Total

9815

9815

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

9626

98.07%

Moderate

189

1.93%

Total

9815

100.00%



Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

3347

34.1%

Genetically altered without a harmful phenotype

6214

63.31%

Genetically altered with a harmful phenotype

254

2.59%

Total

9815

100.00%



Member State: Romania, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

7975

55.86%

Rats

4367

30.59%

Guinea-Pigs

792

5.55%

Hamsters (Syrian)

150

1.05%

Rabbits

318

2.23%

Pigs

58

0.41%

Sheep

85

0.6%

Domestic fowl

280

1.96%

Other birds

23

0.16%

Rana

230

1.61%

Total

14278

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

12356

86.54%

Animals born in the EU but not at a registered breeder

1922

13.46%

Total

14278

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

7975

7975

Rats

4367

4367

Guinea-Pigs

792

792

Hamsters (Syrian)

150

150

Rabbits

318

186

504

Horses, donkeys and cross-breeds

2

2

Pigs

58

58

Sheep

85

124

209

Cattle

2

2

Domestic fowl

280

50

330

Other birds

23

23

Rana

230

230

Total

14278

364

14642

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

5381

36.75%

Translational and applied research

5500

37.56%

Regulatory use and Routine production

2522

17.22%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1239

8.46%

Total

14642

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

1525

28.34%

Cardiovascular Blood and Lymphatic System

539

10.02%

Nervous System

634

11.78%

Gastrointestinal System including Liver

165

3.07%

Musculoskeletal System

339

6.3%

Immune System

1349

25.07%

Urogenital/Reproductive System

70

1.3%

Sensory Organs (skin, eyes and ears)

10

0.19%

Endocrine System/Metabolism

318

5.91%

Multisystemic

342

6.36%

Ethology / Animal Behaviour /Animal Biology

90

1.67%

Total

5381

100.00%



Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Infectious Disorders

114

2.07%

Human Cardiovascular Disorders

211

3.84%

Human Gastrointestinal Disorders including Liver

286

5.2%

Human Musculoskeletal Disorders

260

4.73%

Human Immune Disorders

275

5%

Human Sensory Organ Disorders (skin, eyes and ears)

121

2.2%

Human Endocrine/Metabolism Disorders

690

12.55%

Animal Diseases and Disorders

74

1.35%

Diagnosis of diseases

3040

55.27%

Non-regulatory toxicology and ecotoxicology

429

7.8%

Total

5500

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1789

70.94%

Toxicity and other safety testing including pharmacology

106

4.2%

Routine production

627

24.86%

Total

2522

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

721

40.3%

Pyrogenicity testing

234

13.08%

Batch potency testing

753

42.09%

Other quality controls

81

4.53%

Total

1789

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

20

18.87%

Ecotoxicity

86

81.13%

Total

106

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

Non lethal methods

20

100%

Total

20

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Chronic toxicity

86

100%

Total

86

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

914

48.23%

Legislation on medicinal products for veterinary use and their residues

875

46.17%

Medical devices legislation

86

4.54%

Food legislation including food contact material

20

1.06%

Total

1895

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

1513

79.84%

Legislation satisfying Non-EU requirements only

382

20.16%

Total

1895

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

587

93.62%

Other product types

40

6.38%

Total

627

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

14278

97.51%

Yes

364

2.49%

Total

14642

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

2110

14.41%

Mild [up to and including]

5061

34.56%

Moderate

6094

41.62%

Severe

1377

9.4%

Total

14642

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

14289

97.59%

Genetically altered without a harmful phenotype

353

2.41%

Total

14642

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

No data reported

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported



Member State: Slovakia, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

5547

37.72%

Rats

7619

51.81%

Guinea-Pigs

1036

7.05%

Mongolian gerbil

9

0.06%

Rabbits

195

1.33%

Cats

11

0.07%

Cattle

1

0.01%

Domestic fowl

228

1.55%

Other birds

59

0.4%

Total

14705

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

14705

100%

Total

14705

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

5547

5547

Rats

7619

7619

Guinea-Pigs

1036

1036

Mongolian gerbil

9

9

Rabbits

195

31

226

Cats

11

11

Sheep

2

2

Cattle

1

1

Domestic fowl

228

5

233

Other birds

59

59

Total

14705

38

14743

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

10819

73.38%

Translational and applied research

1046

7.09%

Regulatory use and Routine production

2822

19.14%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

56

0.38%

Total

14743

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

316

2.92%

Cardiovascular Blood and Lymphatic System

932

8.61%

Nervous System

4076

37.67%

Respiratory System

607

5.61%

Gastrointestinal System including Liver

180

1.66%

Musculoskeletal System

19

0.18%

Immune System

424

3.92%

Urogenital/Reproductive System

1175

10.86%

Sensory Organs (skin, eyes and ears)

9

0.08%

Endocrine System/Metabolism

610

5.64%

Multisystemic

782

7.23%

Ethology / Animal Behaviour /Animal Biology

595

5.5%

Other basic research

1094

10.11%

Total

10819

100.00%



Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cardiovascular Disorders

20

1.91%

Human Nervous and Mental Disorders

528

50.48%

Human Immune Disorders

21

2.01%

Human Urogenital/Reproductive Disorders

10

0.96%

Human Sensory Organ Disorders (skin, eyes and ears)

27

2.58%

Human Endocrine/Metabolism Disorders

60

5.74%

Animal Diseases and Disorders

374

35.76%

Diagnosis of diseases

6

0.57%

Total

1046

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

1014

35.93%

Toxicity and other safety testing including pharmacology

1777

62.97%

Routine production

31

1.1%

Total

2822

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

867

85.5%

Batch potency testing

147

14.5%

Total

1014

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

653

36.75%

Skin sensitisation

542

30.5%

Repeated dose toxicity

460

25.89%

Reproductive toxicity

122

6.87%

Total

1777

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

603

92.34%

Non lethal methods

50

7.66%

Total

653

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

280

60.87%

29 - 90 days

180

39.13%

Total

460

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1269

45.47%

Legislation on medicinal products for veterinary use and their residues

133

4.77%

Medical devices legislation

64

2.29%

Industrial chemicals legislation

946

33.89%

Plant protection product legislation

9

0.32%

Food legislation including food contact material

190

6.81%

Feed legislation including legislation for the safety of target animals, workers and environment

180

6.45%

Total

2791

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2791

100%

Total

2791

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

31

100%

Total

31

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

14705

99.74%

Yes

38

0.26%

Total

14743

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

1101

7.47%

Mild [up to and including]

4325

29.34%

Moderate

8963

60.79%

Severe

354

2.4%

Total

14743

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

13516

91.68%

Genetically altered without a harmful phenotype

242

1.64%

Genetically altered with a harmful phenotype

985

6.68%

Total

14743

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

No data reported

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

No data reported

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

540

540

Rats

320

320

Total

860

860

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

860

100%

Total

860

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

588

68.37%

Genetically altered without a harmful phenotype

18

2.09%

Genetically altered with a harmful phenotype

254

29.53%

Total

860

100.00%

Member State: Slovenia, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

3998

88.57%

Rats

226

5.01%

Rabbits

76

1.68%

Pigs

80

1.77%

Sheep

26

0.58%

Domestic fowl

10

0.22%

Other Fish

98

2.17%

Total

4514

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

4514

100%

Total

4514

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

No data reported

Generation of non-human primates

NHP Generation

Number of animals

Percentage

No data reported



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

3998

510

4508

Rats

226

226

Rabbits

76

59

135

Horses, donkeys and cross-breeds

2

2

Pigs

80

80

Sheep

26

2

28

Domestic fowl

10

10

Other Fish

98

98

Total

4514

573

5087

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

1035

20.35%

Translational and applied research

1731

34.03%

Regulatory use and Routine production

2183

42.91%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

16

0.31%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

122

2.4%

Total

5087

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

149

14.4%

Nervous System

70

6.76%

Gastrointestinal System including Liver

150

14.49%

Musculoskeletal System

34

3.29%

Immune System

102

9.86%

Endocrine System/Metabolism

375

36.23%

Multisystemic

59

5.7%

Ethology / Animal Behaviour /Animal Biology

48

4.64%

Other basic research

48

4.64%

Total

1035

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

1552

89.66%

Human Endocrine/Metabolism Disorders

65

3.76%

Diagnosis of diseases

114

6.59%

Total

1731

100.00%



Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

2101

96.24%

Toxicity and other safety testing including pharmacology

82

3.76%

Total

2183

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

272

12.95%

Pyrogenicity testing

59

2.81%

Batch potency testing

1770

84.25%

Total

2101

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Kinetics

82

100%

Total

82

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

2183

100%

Total

2183

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2183

100%

Total

2183

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

4514

88.74%

Yes

573

11.26%

Total

5087

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

44

0.86%

Mild [up to and including]

4317

84.86%

Moderate

637

12.52%

Severe

89

1.75%

Total

5087

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

4736

93.1%

Genetically altered without a harmful phenotype

288

5.66%

Genetically altered with a harmful phenotype

63

1.24%

Total

5087

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

55

55

Total

55

55

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

55

100%

Total

55

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

55

100%

Total

55

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

No data reported

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Other Human Disorders

55

100%

Total

55

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

No data reported

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

No data reported



Member State: Spain, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

465870

65.1%

Rats

55826

7.8%

Guinea-Pigs

6411

0.9%

Hamsters (Syrian)

599

0.08%

Other Rodents

141

0.02%

Rabbits

22205

3.1%

Cats

178

0.02%

Dogs

1045

0.15%

Ferrets

164

0.02%

Other carnivores

25

0%

Horses, donkeys and cross-breeds

46

0.01%

Pigs

8655

1.21%

Goats

354

0.05%

Sheep

1715

0.24%

Cattle

1138

0.16%

Cynomolgus monkey

246

0.03%

Other Mammals

99

0.01%

Domestic fowl

82047

11.46%

Other birds

2385

0.33%

Reptiles

1003

0.14%

Rana

18

0%

Xenopus

1204

0.17%

Other Amphibians

1996

0.28%

Zebra fish

19941

2.79%

Other Fish

42320

5.91%

Cephalopods

20

0%

Total

715651

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

668867

93.49%

Animals born in the EU but not at a registered breeder

45911

6.42%

Animals born in rest of Europe

31

0%

Animals born in rest of world

596

0.08%

Total

715405

100.00%



Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born in Asia

104

42.28%

Animals born in Africa

142

57.72%

Total

246

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F1

2

0.81%

F2 or greater

244

99.19%

Total

246

100.00%



Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

465870

1335

467205

Rats

55826

162

55988

Guinea-Pigs

6411

336

6747

Hamsters (Syrian)

599

599

Other Rodents

141

141

Rabbits

22205

3726

25931

Cats

178

353

531

Dogs

1045

431

1476

Ferrets

164

164

Other carnivores

25

25

Horses, donkeys and cross-breeds

46

15

61

Pigs

8655

8655

Goats

354

15

369

Sheep

1715

238

1953

Cattle

1138

562

1700

Cynomolgus monkey

246

205

451

Other Mammals

99

99

Domestic fowl

82047

60

82107

Other birds

2385

150

2535

Reptiles

1003

1003

Rana

18

18

Xenopus

1204

1204

Other Amphibians

1996

1996

Zebra fish

19941

1434

21375

Other Fish

42320

1160

43480

Cephalopods

20

20

Total

715651

10182

725833

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

310014

42.71%

Translational and applied research

277423

38.22%

Regulatory use and Routine production

120192

16.56%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

6048

0.83%

Preservation of species

371

0.05%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

11785

1.62%

Total

725833

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

26149

8.43%

Cardiovascular Blood and Lymphatic System

25464

8.21%

Nervous System

76225

24.59%

Respiratory System

2457

0.79%

Gastrointestinal System including Liver

8392

2.71%

Musculoskeletal System

6847

2.21%

Immune System

23703

7.65%

Urogenital/Reproductive System

6421

2.07%

Sensory Organs (skin, eyes and ears)

4396

1.42%

Endocrine System/Metabolism

22459

7.24%

Multisystemic

33719

10.88%

Ethology / Animal Behaviour /Animal Biology

71415

23.04%

Other basic research

2367

0.76%

Total

310014

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

113728

40.99%

Human Infectious Disorders

13579

4.89%

Human Cardiovascular Disorders

6440

2.32%

Human Nervous and Mental Disorders

20809

7.5%

Human Respiratory Disorders

2713

0.98%

Human Gastrointestinal Disorders including Liver

8755

3.16%

Human Musculoskeletal Disorders

2052

0.74%

Human Immune Disorders

4675

1.69%

Human Urogenital/Reproductive Disorders

1160

0.42%

Human Sensory Organ Disorders (skin, eyes and ears)

15749

5.68%

Human Endocrine/Metabolism Disorders

15631

5.63%

Other Human Disorders

1651

0.6%

Animal Diseases and Disorders

50632

18.25%

Animal Welfare

8413

3.03%

Diagnosis of diseases

9346

3.37%

Plant diseases

10

0%

Non-regulatory toxicology and ecotoxicology

2080

0.75%

Total

277423

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

68653

57.12%

Other efficacy and tolerance testing

2121

1.76%

Toxicity and other safety testing including pharmacology

48164

40.07%

Routine production

1254

1.04%

Total

120192

100.00%



Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

23330

33.98%

Pyrogenicity testing

9472

13.8%

Batch potency testing

31416

45.76%

Other quality controls

4435

6.46%

Total

68653

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

11069

22.98%

Skin irritation/corrosion

43

0.09%

Skin sensitisation

616

1.28%

Eye irritation/corrosion

11

0.02%

Repeated dose toxicity

6225

12.92%

Carcinogenicity

56

0.12%

Genotoxicity

22

0.05%

Developmental toxicity

759

1.58%

Neurotoxicity

2017

4.19%

Kinetics

3364

6.98%

Pharmaco-dynamics (incl safety pharmacology)

1476

3.06%

Ecotoxicity

156

0.32%

Safety testing in food and feed area

21778

45.22%

Target animal safety

486

1.01%

Other toxicity/safety testing

86

0.18%

Total

48164

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

10180

91.97%

Non lethal methods

889

8.03%

Total

11069

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

1906

30.62%

29 - 90 days

3714

59.66%

> 90 days

605

9.72%

Total

6225

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

124

79.49%

Reproductive ecotoxicity

32

20.51%

Total

156

100.00%



Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

32259

27.12%

Legislation on medicinal products for veterinary use and their residues

61342

51.57%

Medical devices legislation

138

0.12%

Industrial chemicals legislation

3194

2.69%

Plant protection product legislation

28

0.02%

Biocides legislation

56

0.05%

Food legislation including food contact material

21850

18.37%

Feed legislation including legislation for the safety of target animals, workers and environment

68

0.06%

Other legislation

3

0%

Total

118938

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

106010

89.13%

Legislation satisfying national requirements only [within EU]

4057

3.41%

Legislation satisfying Non-EU requirements only

8871

7.46%

Total

118938

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

54

4.31%

Monoclonal antibody by mouse ascites method

55

4.39%

Other product types

1145

91.31%

Total

1254

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

715651

98.6%

Yes

10182

1.4%

Total

725833

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

40892

5.63%

Mild [up to and including]

355722

49.01%

Moderate

266570

36.73%

Severe

62649

8.63%

Total

725833

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

501844

69.14%

Genetically altered without a harmful phenotype

201157

27.71%

Genetically altered with a harmful phenotype

22832

3.15%

Total

725833

100.00%

Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

17749

70

17819

Rats

48

48

Pigs

1

1

Zebra fish

4886

4886

Other Fish

1187

1187

Total

23871

70

23941

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

176

0.74%

Mild [up to and including]

16644

69.52%

Moderate

5213

21.77%

Severe

1908

7.97%

Total

23941

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

9606

40.12%

Genetically altered without a harmful phenotype

13230

55.26%

Genetically altered with a harmful phenotype

1105

4.62%

Total

23941

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

2268

11.63%

Cardiovascular Blood and Lymphatic System

800

4.1%

Nervous System

2745

14.08%

Gastrointestinal System including Liver

493

2.53%

Musculoskeletal System

150

0.77%

Immune System

956

4.9%

Urogenital/Reproductive System

127

0.65%

Sensory Organs (skin, eyes and ears)

5887

30.2%

Endocrine System/Metabolism

175

0.9%

Multisystemic

4093

21%

Ethology / Animal Behaviour /Animal Biology

1800

9.23%

Total

19494

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cancer

2869

64.52%

Human Nervous and Mental Disorders

585

13.15%

Human Immune Disorders

418

9.4%

Human Sensory Organ Disorders (skin, eyes and ears)

52

1.17%

Human Endocrine/Metabolism Disorders

21

0.47%

Diagnosis of diseases

502

11.29%

Total

4447

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

38443

38443

Zebra fish

14759

14759

Total

53202

53202

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

135

0.25%

Mild [up to and including]

42728

80.31%

Moderate

8998

16.91%

Severe

1341

2.52%

Total

53202

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

1285

2.42%

Genetically altered without a harmful phenotype

29469

55.39%

Genetically altered with a harmful phenotype

22448

42.19%

Total

53202

100.00%



Member State: Sweden, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

193965

67.99%

Rats

19055

6.68%

Guinea-Pigs

409

0.14%

Hamsters (Syrian)

34

0.01%

Other Rodents

5

0%

Rabbits

1573

0.55%

Cats

104

0.04%

Dogs

279

0.1%

Other carnivores

124

0.04%

Horses, donkeys and cross-breeds

17

0.01%

Pigs

1220

0.43%

Goats

30

0.01%

Sheep

35

0.01%

Cattle

493

0.17%

Cynomolgus monkey

2

0%

Rhesus monkey

23

0.01%

Other Mammals

192

0.07%

Domestic fowl

1452

0.51%

Other birds

10657

3.74%

Rana

308

0.11%

Xenopus

231

0.08%

Other Amphibians

2694

0.94%

Zebra fish

18461

6.47%

Other Fish

33940

11.9%

Total

285303

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

217256

76.16%

Animals born in the EU but not at a registered breeder

64066

22.46%

Animals born in rest of Europe

1608

0.56%

Animals born in rest of world

2348

0.82%

Total

285278

100.00%

Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born in Asia

6

24%

Animals born in America

19

76%

Total

25

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F2 or greater

25

100%

Total

25

100.00%

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

193965

1228

195193

Rats

19055

246

19301

Guinea-Pigs

409

409

Hamsters (Syrian)

34

34

Other Rodents

5

5

Rabbits

1573

1

1574

Cats

104

104

Dogs

279

107

386

Other carnivores

124

16

140

Horses, donkeys and cross-breeds

17

24

41

Pigs

1220

337

1557

Goats

30

30

Sheep

35

35

Cattle

493

927

1420

Cynomolgus monkey

2

2

Rhesus monkey

23

23

Other Mammals

192

135

327

Domestic fowl

1452

1452

Other birds

10657

612

11269

Rana

308

308

Xenopus

231

30

261

Other Amphibians

2694

2694

Zebra fish

18461

880

19341

Other Fish

33940

33940

Total

285303

4543

289846

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

202004

69.69%

Translational and applied research

52637

18.16%

Regulatory use and Routine production

2424

0.84%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

27916

9.63%

Preservation of species

617

0.21%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

4248

1.47%

Total

289846

100.00%



Basic research related uses

Basic research

Number of uses

Percentage

Oncology

20290

10.04%

Cardiovascular Blood and Lymphatic System

36103

17.87%

Nervous System

48921

24.22%

Respiratory System

7362

3.64%

Gastrointestinal System including Liver

1383

0.68%

Musculoskeletal System

2641

1.31%

Immune System

22592

11.18%

Urogenital/Reproductive System

1521

0.75%

Sensory Organs (skin, eyes and ears)

3150

1.56%

Endocrine System/Metabolism

25884

12.81%

Multisystemic

6172

3.06%

Ethology / Animal Behaviour /Animal Biology

16914

8.37%

Other basic research

9071

4.49%

Total

202004

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

9717

18.46%

Human Infectious Disorders

1328

2.52%

Human Cardiovascular Disorders

4936

9.38%

Human Nervous and Mental Disorders

9654

18.34%

Human Respiratory Disorders

4988

9.48%

Human Musculoskeletal Disorders

862

1.64%

Human Immune Disorders

9224

17.52%

Human Urogenital/Reproductive Disorders

255

0.48%

Human Sensory Organ Disorders (skin, eyes and ears)

500

0.95%

Human Endocrine/Metabolism Disorders

5501

10.45%

Other Human Disorders

2323

4.41%

Animal Diseases and Disorders

704

1.34%

Animal Welfare

105

0.2%

Diagnosis of diseases

542

1.03%

Non-regulatory toxicology and ecotoxicology

1998

3.8%

Total

52637

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

773

31.89%

Other efficacy and tolerance testing

235

9.69%

Toxicity and other safety testing including pharmacology

1416

58.42%

Total

2424

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch potency testing

773

100%

Total

773

100.00%



Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Repeated dose toxicity

113

7.98%

Kinetics

1303

92.02%

Total

1416

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

No data reported

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

113

100%

Total

113

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

No data reported

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

1651

68.11%

Legislation on medicinal products for veterinary use and their residues

773

31.89%

Total

2424

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

2424

100%

Total

2424

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

No data reported

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

285303

98.43%

Yes

4543

1.57%

Total

289846

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

9102

3.14%

Mild [up to and including]

92527

31.92%

Moderate

153733

53.04%

Severe

34484

11.9%

Total

289846

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

144621

49.9%

Genetically altered without a harmful phenotype

118948

41.04%

Genetically altered with a harmful phenotype

26277

9.07%

Total

289846

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

22641

788

23429

Zebra fish

8546

1271

9817

Total

31187

2059

33246

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

222

0.67%

Mild [up to and including]

15644

47.06%

Moderate

10806

32.5%

Severe

6574

19.77%

Total

33246

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

4166

12.53%

Genetically altered without a harmful phenotype

18428

55.43%

Genetically altered with a harmful phenotype

10652

32.04%

Total

33246

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

2259

7.49%

Cardiovascular Blood and Lymphatic System

8399

27.84%

Nervous System

4504

14.93%

Gastrointestinal System including Liver

148

0.49%

Musculoskeletal System

1579

5.23%

Immune System

602

2%

Urogenital/Reproductive System

5022

16.65%

Endocrine System/Metabolism

2171

7.2%

Multisystemic

4029

13.35%

Other basic research

1457

4.83%

Total

30170

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cancer

1124

36.54%

Human Cardiovascular Disorders

1547

50.29%

Human Nervous and Mental Disorders

83

2.7%

Human Respiratory Disorders

89

2.89%

Human Immune Disorders

47

1.53%

Human Endocrine/Metabolism Disorders

186

6.05%

Total

3076

100.00%



All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

1659

1659

Rats

20

20

Total

1679

1679

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Mild [up to and including]

1679

100%

Total

1679

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

1183

70.46%

Genetically altered without a harmful phenotype

496

29.54%

Total

1679

100.00%



Member State: United Kingdom, 2017

Part 1: Numbers of animals used for the first time for research, testing, routine production and educational (including training) purposes

Numbers of animals used for the first time by species

Animal species

Number of animals

Percentage

Mice

1103996

60.03%

Rats

231775

12.6%

Guinea-Pigs

22560

1.23%

Hamsters (Syrian)

1126

0.06%

Mongolian gerbil

307

0.02%

Other Rodents

2325

0.13%

Rabbits

9580

0.52%

Cats

74

0%

Dogs

2518

0.14%

Ferrets

405

0.02%

Other carnivores

235

0.01%

Horses, donkeys and cross-breeds

288

0.02%

Pigs

4476

0.24%

Goats

280

0.02%

Sheep

5346

0.29%

Cattle

8489

0.46%

Marmoset and tamarins

110

0.01%

Cynomolgus monkey

2023

0.11%

Rhesus monkey

82

0%

Other Mammals

792

0.04%

Domestic fowl

124629

6.78%

Other birds

6258

0.34%

Reptiles

92

0.01%

Rana

108

0.01%

Xenopus

2530

0.14%

Other Amphibians

522

0.03%

Zebra fish

216671

11.78%

Other Fish

91482

4.97%

Total

1839079

100.00%

Place of birth of animals other than non-human primates

Place of birth

Number of animals

Percentage

Animals born in the EU at a registered breeder

1710834

93.14%

Animals born in the EU but not at a registered breeder

112655

6.13%

Animals born in rest of Europe

3229

0.18%

Animals born in rest of world

10146

0.55%

Total

1836864

100.00%



Source of non-human primates

NHP Source (origin)

Number of animals

Percentage

Animals born at a registered breeder within EU

253

11.42%

Animals born in Asia

616

27.81%

Animals born in Africa

1346

60.77%

Total

2215

100.00%

Generation of non-human primates

NHP Generation

Number of animals

Percentage

F1

1

0.05%

F2 or greater

587

26.5%

Self-sustaining colony

1627

73.45%

Total

2215

100.00%

Part 2: Numbers of all uses of animals for research, testing, routine production and educational (including training) purposes

First use versus reuses

Animal species

First uses

Reuses

Total

Mice

1103996

944

1104940

Rats

231775

3006

234781

Guinea-Pigs

22560

22560

Hamsters (Syrian)

1126

1126

Mongolian gerbil

307

4

311

Other Rodents

2325

2

2327

Rabbits

9580

864

10444

Cats

74

214

288

Dogs

2518

1431

3949

Ferrets

405

405

Other carnivores

235

9

244

Horses, donkeys and cross-breeds

288

10312

10600

Pigs

4476

142

4618

Goats

280

24

304

Sheep

5346

42583

47929

Cattle

8489

596

9085

Marmoset and tamarins

110

56

166

Cynomolgus monkey

2023

639

2662

Rhesus monkey

82

50

132

Other Mammals

792

12

804

Domestic fowl

124629

27

124656

Other birds

6258

471

6729

Reptiles

92

92

Rana

108

108

Xenopus

2530

4923

7453

Other Amphibians

522

11

533

Zebra fish

216671

439

217110

Other Fish

91482

150

91632

Total

1839079

66909

1905988

Uses of animals in research, testing, routine production and education (including training) by main categories of scientific purposes

Purpose Category

Number of uses

Percentage

Basic Research

1058370

55.53%

Translational and applied research

326965

17.15%

Regulatory use and Routine production

505504

26.52%

Protection of the natural environment in the interests of the health or welfare of human beings or animals

11901

0.62%

Preservation of species

1925

0.1%

Higher education or training for the acquisition, maintenance or improvement of vocational skills

1235

0.06%

Forensic enquiries

88

0%

Total

1905988

100.00%

Basic research related uses

Basic research

Number of uses

Percentage

Oncology

130655

12.34%

Cardiovascular Blood and Lymphatic System

67776

6.4%

Nervous System

243752

23.03%

Respiratory System

10995

1.04%

Gastrointestinal System including Liver

22962

2.17%

Musculoskeletal System

24477

2.31%

Immune System

213921

20.21%

Urogenital/Reproductive System

28064

2.65%

Sensory Organs (skin, eyes and ears)

17935

1.69%

Endocrine System/Metabolism

25990

2.46%

Multisystemic

80548

7.61%

Ethology / Animal Behaviour /Animal Biology

64369

6.08%

Other basic research

126926

11.99%

Total

1058370

100.00%

Translational and applied research related uses

Translational and applied research

Number of uses

Percentage

Human Cancer

86658

26.5%

Human Infectious Disorders

69473

21.25%

Human Cardiovascular Disorders

4173

1.28%

Human Nervous and Mental Disorders

42005

12.85%

Human Respiratory Disorders

12633

3.86%

Human Gastrointestinal Disorders including Liver

3943

1.21%

Human Musculoskeletal Disorders

5958

1.82%

Human Immune Disorders

6481

1.98%

Human Urogenital/Reproductive Disorders

3061

0.94%

Human Sensory Organ Disorders (skin, eyes and ears)

10774

3.3%

Human Endocrine/Metabolism Disorders

7815

2.39%

Other Human Disorders

10802

3.3%

Animal Diseases and Disorders

21921

6.7%

Animal Welfare

2843

0.87%

Diagnosis of diseases

3476

1.06%

Non-regulatory toxicology and ecotoxicology

34949

10.69%

Total

326965

100.00%

Regulatory uses and Routine production

Regulatory uses and Routine production

Number of uses

Percentage

Quality control (incl batch safety and potency testing)

145113

28.71%

Other efficacy and tolerance testing

24606

4.87%

Toxicity and other safety testing including pharmacology

196061

38.79%

Routine production

139724

27.64%

Total

505504

100.00%

Regulatory uses - Quality control (including batch safety and potency testing)

Regulatory uses - Quality control (including batch safety and potency testing)

Number of uses

Percentage

Batch safety testing

18401

12.68%

Pyrogenicity testing

1125

0.78%

Batch potency testing

114151

78.66%

Other quality controls

11436

7.88%

Total

145113

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology

Regulatory uses - Toxicity and other safety testing including pharmacology

Number of uses

Percentage

Acute and sub-acute

16580

8.46%

Skin irritation/corrosion

112

0.06%

Skin sensitisation

2942

1.5%

Eye irritation/corrosion

63

0.03%

Repeated dose toxicity

40429

20.62%

Carcinogenicity

8067

4.11%

Genotoxicity

5314

2.71%

Reproductive toxicity

61241

31.24%

Developmental toxicity

34779

17.74%

Neurotoxicity

314

0.16%

Kinetics

3124

1.59%

Pharmaco-dynamics (incl safety pharmacology)

5309

2.71%

Ecotoxicity

11444

5.84%

Safety testing in food and feed area

183

0.09%

Target animal safety

1360

0.69%

Other toxicity/safety testing

4800

2.45%

Total

196061

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Regulatory uses - Toxicity and other safety testing including pharmacology - Acute and sub-acute toxicity testing methods

Number of uses

Percentage

LD50, LC50

10622

64.07%

Other lethal methods

98

0.59%

Non lethal methods

5860

35.34%

Total

16580

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Repeated dose toxicity

Number of uses

Percentage

up to 28 days

21572

53.36%

29 - 90 days

11727

29.01%

> 90 days

7130

17.64%

Total

40429

100.00%

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Regulatory uses - Toxicity and other safety testing including pharmacology - Ecotoxicity

Number of uses

Percentage

Acute toxicity

3653

31.92%

Chronic toxicity

6320

55.23%

Reproductive ecotoxicity

514

4.49%

Endocrine activity

84

0.73%

Bioaccumulation

873

7.63%

Total

11444

100.00%

Regulatory uses by type of legislation

Type of legislation

Number of uses

Percentage

Legislation on medicinal products for human use

208034

56.87%

Legislation on medicinal products for veterinary use and their residues

34282

9.37%

Medical devices legislation

562

0.15%

Industrial chemicals legislation

86097

23.54%

Plant protection product legislation

18417

5.03%

Biocides legislation

292

0.08%

Food legislation including food contact material

1688

0.46%

Feed legislation including legislation for the safety of target animals, workers and environment

14831

4.05%

Other legislation

1577

0.43%

Total

365780

100.00%

Regulatory uses by origin of regulatory requirement

Origin of legislative requirement

Number of uses

Percentage

Legislation satisfying EU requirements

338692

92.59%

Legislation satisfying national requirements only [within EU]

1651

0.45%

Legislation satisfying Non-EU requirements only

25437

6.95%

Total

365780

100.00%

Routine production uses by product type

Product type

Number of uses

Percentage

Blood based products

55197

39.5%

Other product types

84527

60.5%

Total

139724

100.00%

Uses of animals in research, testing, routine production and education (including training) by first use and reuses

Reuse

Number of uses

Percentage

No

1839079

96.49%

Yes

66909

3.51%

Total

1905988

100.00%

Uses of animals in research, testing, routine production and education (including training) by severity

Severity

Number of uses

Percentage

Non-recovery

135307

7.1%

Mild [up to and including]

1171215

61.45%

Moderate

504038

26.44%

Severe

95428

5.01%

Total

1905988

100.00%

Uses of animals in research, testing, routine production and education (including training) by genetic status of animals

Genetic status

Number of uses

Percentage

Not genetically altered

1182220

62.03%

Genetically altered without a harmful phenotype

596728

31.31%

Genetically altered with a harmful phenotype

127040

6.67%

Total

1905988

100.00%



Part 3: Creation and maintenance of genetically altered animal lines

All uses of animals for the creation of new genetically altered animal lines by species, first uses and reuses

Animal species

First uses

Reuses

Total

Mice

213555

393

213948

Rats

131

131

Pigs

124

124

Sheep

17

17

Domestic fowl

647

647

Xenopus

250

250

Zebra fish

49941

82

50023

Other Fish

34

34

Total

264699

475

265174

Uses of animals for the creation of new genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

201

0.08%

Mild [up to and including]

241543

91.09%

Moderate

21638

8.16%

Severe

1792

0.68%

Total

265174

100.00%

Uses of animals for the creation of new genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

56940

21.47%

Genetically altered without a harmful phenotype

191024

72.04%

Genetically altered with a harmful phenotype

17210

6.49%

Total

265174

100.00%

Uses of animals for the creation of new genetically altered animal lines by type of basic research purposes

Basic research

Number of uses

Percentage

Oncology

45369

17.71%

Cardiovascular Blood and Lymphatic System

10621

4.15%

Nervous System

29420

11.48%

Respiratory System

659

0.26%

Gastrointestinal System including Liver

3235

1.26%

Musculoskeletal System

3946

1.54%

Immune System

32311

12.61%

Urogenital/Reproductive System

6774

2.64%

Sensory Organs (skin, eyes and ears)

5542

2.16%

Endocrine System/Metabolism

3421

1.34%

Multisystemic

92818

36.23%

Ethology / Animal Behaviour /Animal Biology

2854

1.11%

Other basic research

19201

7.5%

Total

256171

100.00%



Uses of animals for the creation of new genetically altered animal lines by type of translational and applied research purposes

Translational and applied research

Number of uses

Percentage

Human Cancer

4221

46.88%

Human Infectious Disorders

730

8.11%

Human Cardiovascular Disorders

201

2.23%

Human Nervous and Mental Disorders

349

3.88%

Human Musculoskeletal Disorders

155

1.72%

Human Immune Disorders

873

9.7%

Human Urogenital/Reproductive Disorders

480

5.33%

Human Sensory Organ Disorders (skin, eyes and ears)

80

0.89%

Other Human Disorders

48

0.53%

Animal Diseases and Disorders

1586

17.62%

Non-regulatory toxicology and ecotoxicology

280

3.11%

Total

9003

100.00%

All uses of animals for the maintenance of established genetically altered animal lines by species

Animal species

First uses

Reuses

Total uses

Mice

346497

1

346498

Rats

2919

2919

Domestic fowl

367

367

Xenopus

195

197

392

Zebra fish

52401

612

53013

Other Fish

524

524

Total

402903

810

403713

Uses of animals for the maintenance of established genetically altered animal lines by severity

Severity

Number of uses

Percentage

Non-recovery

272

0.07%

Mild [up to and including]

328866

81.46%

Moderate

33725

8.35%

Severe

40850

10.12%

Total

403713

100.00%

Uses of animals for the maintenance of established genetically altered animal lines by genetic status of the animals

Genetic status

Number of uses

Percentage

Not genetically altered

24437

6.05%

Genetically altered without a harmful phenotype

315057

78.04%

Genetically altered with a harmful phenotype

64219

15.91%

Total

403713

100.00%

Top

Brussels, 5.2.2020

SWD(2020) 10 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

2019 report on the statistics on the use of animals for scientific purposes in the Member States of the European Union in 2015-2017













{COM(2020) 16 final}


SECTION C: MEMBER STATE DATA BETWEEN 2015 AND 2017

SECTION C: MEMBER STATE DATA BETWEEN 2015 AND 2017    

V.4. Member State comparative tables for 2017    

Introduction    

Table 1.1: Numbers of animals used for the first time for research, testing, routine production and educational purposes by species and Member State (Part 1)    

Table 1.2: Numbers of animals used for the first time for research, testing, routine production and educational purposes by species and Member State (Part2)    

Table 2.1: All uses (first use and all subsequent reuses) of animals for research, testing, routine production and educational purposes by species and Member State (Part 1)    

Table 2.2: All uses (first use and all subsequent reuses) of animals for research, testing, routine production and educational purposes by species and Member State (Part2)    

Table 3.1: Uses of animals for the creation of new genetically altered animal lines in basic, translational and applied research by species, reuse and Member State1)    

Table 3.2: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, reuse and Member State1)    



V.4. Member State comparative tables for 2017

Introduction

Based on the recalculated Member State data, three comparative tables are provided for 2017 covering:

·Numbers of animals, by species, used for purposes of research, testing, routine production and education (including training)

·Numbers of all uses (first and any subsequent reuse) of animals, by species, for the purposes of research, testing, routine production and education (including training)

·Numbers and uses of animals, by species, for the creation and maintenance of genetically altered animals



Table 1.1: Numbers of animals used for the first time for research, testing, routine production and educational purposes by species and Member State (Part 1) (2017)

AT

BE

BG

CY

CZ

DE

DK

EE

EL

ES

FI

FR

HR

HU

IE

Mammals

Rodents

Mice

169,345

306,605

989

1,209

71,954

1,171,550

159,566

2,168

21,190

465,870

48,580

1,011,925

19,710

65,368

205,849

Rats

5,309

23,207

1,892

0

24,809

245,998

37,955

296

2,435

55,826

13,467

173,535

7,638

33,255

16,858

Guinea-Pigs

1,127

15,539

1,841

0

1,377

14,349

2,932

0

6

6,411

9

44,976

16

5,731

518

Hamsters (Syrian)

0

1,147

0

0

15

1,217

282

0

0

599

149

6,529

0

0

0

Hamsters (Chinese)

0

0

0

0

0

8

0

0

0

0

0

167

0

0

0

Mongolian gerbil

0

174

0

0

46

4,154

0

0

0

0

0

429

0

0

0

Other rodents

998

115

0

0

635

9,950

3

0

0

141

690

857

0

0

0

Rabbits

Rabbits

10,367

57,849

568

0

2,031

89,147

2,439

0

213

22,205

223

124,544

426

1,343

400

Carnivores

Cats

61

53

30

0

121

431

0

0

0

178

311

315

0

16

0

Dogs

149

334

0

0

437

1,720

69

0

23

1,045

3,035

2,752

0

359

46

Ferrets

0

26

0

0

1

172

4

0

0

164

0

148

0

4

442

Other carnivores

0

0

0

0

1

535

935

0

0

25

107

24

0

0

0

Farm animals

Horses, donkeys and cross-breeds

349

135

0

0

90

1,013

55

0

0

46

30

109

0

0

59

Pigs

2,040

4,847

20

0

1,893

16,069

5,481

4

283

8,655

632

9,261

2

2,078

1,519

Goats

20

77

0

0

91

195

1

0

0

354

0

311

0

0

11

Sheep

139

628

340

0

524

2,832

56

0

8

1,715

1,319

2,633

28

0

1,189

Cattle

904

1,354

15

0

1,413

5,842

3,663

16

3

1,138

207

956

30

12

2,805

Non-human primates

Prosimians

0

0

0

0

0

12

0

0

0

0

0

86

0

0

0

Marmoset and tamarins

0

0

0

0

0

197

0

0

0

0

0

131

0

0

0

Squirrel monkey

0

0

0

0

0

1

0

0

0

0

0

7

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

0

0

0

2,387

0

0

0

246

0

2,001

0

0

0

Rhesus monkey

0

9

0

0

0

67

0

0

0

0

0

26

0

2

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

33

0

0

0

Baboons

0

0

0

0

0

14

0

0

0

0

0

11

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

0

0

0

0

0

9

0

0

0

Other mammals

Other mammals

102

77

0

0

0

1,259

28

0

0

99

1,521

18,125

0

0

0

Birds

Domestic fowl

3,895

39,661

680

0

21,166

24,463

402

0

6

82,047

8,485

42,582

255

20,575

40

Other birds

1,810

6,887

0

0

4,234

11,339

408

180

0

2,385

404

26,997

0

2,084

823

Reptiles

Reptiles

0

42

0

0

558

351

269

0

0

1,003

0

14

0

0

0

Amphibians

Rana

0

0

2,306

0

0

377

0

0

0

18

0

118

0

0

0

Xenopus

941

866

0

0

50

3,405

75

0

0

1,204

0

3,570

0

0

18

Other amphibians

912

71

0

0

531

2,652

47

0

0

1,996

0

742

0

0

0

Fish

Zebra fish

8,112

23,912

0

0

5,414

87,413

1,587

0

1,859

19,941

6,454

16,199

0

928

236

Other fish

4,596

23,538

0

0

74,753

94,180

15,538

0

16,250

42,320

11,729

267,714

0

1,174

9,755

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

33

20

0

1

0

0

0

Totals

Total

211,176

507,153

8,681

1,209

212,144

1,793,299

231,795

2,664

42,309

715,651

97,352

1,757,837

28,105

132,929

240,568

% of total

2.2

5.4

0.1

0

2.3

19.1

2.5

0

0.5

7.6

1

18.7

0.3

1.4

2.6

Table 1.2: Numbers of animals used for the first time for research, testing, routine production and educational purposes by species and Member State (Part2) (2017)

IT

LT

LU

LV

MT

NL

PL

PT

RO

SE

SI

SK

UK

Total

%

Mammals

Rodents

Mice

347,361

1,718

5,348

3,332

0

188,238

88,894

35,221

7,975

193,965

3,998

5,547

1,103,996

5,707,471

60.8

Rats

117,203

391

96

1,795

0

89,294

28,865

3,133

4,367

19,055

226

7,619

231,775

1,146,299

12.2

Guinea-Pigs

14,246

15

0

0

0

5,702

5,232

0

792

409

0

1,036

22,560

144,824

1.5

Hamsters (Syrian)

277

0

0

0

0

1,025

150

0

150

34

0

0

1,126

12,700

0.1

Hamsters (Chinese)

0

0

0

0

0

12

0

0

0

0

0

0

0

187

0

Mongolian gerbil

0

0

0

0

0

0

120

0

0

0

0

9

307

5,239

0.1

Other rodents

647

0

0

0

0

736

7,930

140

0

5

0

0

2,325

25,172

0.3

Rabbits

Rabbits

18,146

13

0

0

0

9,551

718

36

318

1,573

76

195

9,580

351,961

3.7

Carnivores

Cats

0

0

0

0

0

174

0

0

0

104

0

11

74

1,879

0

Dogs

373

0

0

0

0

549

0

0

0

279

0

0

2,518

13,688

0.1

Ferrets

42

0

0

0

0

608

0

0

0

0

0

0

405

2,016

0

Other carnivores

0

0

0

0

0

270

130

0

0

124

0

0

235

2,386

0

Farm animals

Horses, donkeys and cross-breeds

0

0

0

0

0

173

50

0

0

17

0

0

288

2,414

0

Pigs

1,559

68

0

22

0

9,587

1,513

155

58

1,220

80

0

4,476

71,522

0.8

Goats

0

0

0

0

0

176

17

0

0

30

0

0

280

1,563

0

Sheep

120

15

0

0

0

531

1,231

12

85

35

26

0

5,346

18,812

0.2

Cattle

270

0

0

0

0

2,629

403

0

0

493

0

1

8,489

30,643

0.3

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

98

0

Marmoset and tamarins

0

0

0

0

0

27

0

0

0

0

0

0

110

465

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

8

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

3

0

0

0

0

0

0

3

0

Cynomolgus monkey

545

0

0

0

0

23

0

0

0

2

0

0

2,023

7,227

0.1

Rhesus monkey

3

0

0

0

0

141

0

0

0

23

0

0

82

353

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

33

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

25

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

14

0

0

0

0

0

0

23

0

Other mammals

Other mammals

24

0

0

140

0

3,305

639

32

0

192

0

0

792

26,335

0.3

Birds

Domestic fowl

33,358

0

0

0

0

55,152

5,067

120

280

1,452

10

228

124,629

464,553

4.9

Other birds

420

26

0

0

0

17,946

6,470

0

23

10,657

0

59

6,258

99,410

1.1

Reptiles

Reptiles

0

0

0

0

0

294

314

0

0

0

0

0

92

2,937

0

Amphibians

Rana

0

0

0

0

0

0

20

0

230

308

0

0

108

3,485

0

Xenopus

371

0

0

0

0

278

0

0

0

231

0

0

2,530

13,539

0.1

Other amphibians

0

0

0

0

0

60

456

0

0

2,694

0

0

522

10,683

0.1

Fish

Zebra fish

19,415

0

19,849

0

0

51,456

950

906

0

18,461

0

0

216,671

499,763

5.3

Other fish

10,079

520

0

0

250

15,842

5,381

793

0

33,940

98

0

91,482

719,932

7.7

Cephalopods

Cephalopods

10

0

0

0

0

0

0

450

0

0

0

0

0

514

0

Totals

Total

564,469

2,766

25,293

5,289

250

453,779

154,567

40,998

14,278

285,303

4,514

14,705

1,839,079

9,388,162

100

%

6

0

0.3

0.1

0

4.8

1.6

0.4

0.2

3

0

0.2

19.6

100

Table 2.1: All uses (first use and all subsequent reuses) of animals for research, testing, routine production and educational purposes by species and Member State (Part 1) (2017)

AT

BE

BG

CY

CZ

DE

DK

EE

EL

ES

FI

FR

HR

HU

IE

Mammals

Rodents

Mice

169,908

306,919

989

1,209

72,996

1,188,709

160,422

2,168

21,519

467,205

48,631

1,028,083

19,710

65,714

205,849

Rats

5,309

23,604

1,892

0

24,855

250,479

38,498

296

2,438

55,988

13,467

179,613

7,700

33,946

16,858

Guinea-Pigs

1,154

15,541

1,841

0

1,383

14,851

2,947

0

6

6,747

9

45,034

21

5,765

518

Hamsters (Syrian)

8

1,147

0

0

15

1,222

282

0

0

599

149

6,529

0

0

0

Hamsters (Chinese)

0

0

0

0

0

8

0

0

0

0

0

167

0

0

0

Mongolian gerbil

41

174

0

0

46

4,255

0

0

0

0

0

429

0

0

0

Other rodents

998

115

0

0

635

9,950

3

0

0

141

690

957

0

0

0

Rabbits

Rabbits

10,388

57,888

568

0

2,133

92,644

2,443

0

213

25,931

227

126,898

426

1,431

400

Carnivores

Cats

61

61

30

0

132

718

0

0

8

531

311

867

0

16

0

Dogs

203

1,856

0

0

637

3,330

214

0

41

1,476

3,061

4,096

0

463

89

Ferrets

0

26

0

0

1

196

4

0

0

164

0

148

0

4

442

Other carnivores

0

0

0

0

1

535

1,035

0

0

25

107

27

0

0

0

Farm animals

Horses, donkeys and cross-breeds

521

234

0

0

105

1,209

119

0

0

61

77

305

25

0

60

Pigs

2,040

4,970

20

0

2,447

17,283

5,801

4

289

8,655

632

10,346

2

2,405

1,547

Goats

22

78

0

0

97

212

1

0

0

369

0

838

0

0

11

Sheep

149

666

340

0

918

3,053

66

0

8

1,953

1,319

5,396

39

0

1,321

Cattle

908

1,558

15

0

2,734

6,332

3,677

16

3

1,700

216

1,777

30

33

3,244

Non-human primates

Prosimians

0

0

0

0

0

87

0

0

0

0

0

86

0

0

0

Marmoset and tamarins

0

0

0

0

0

214

0

0

0

0

0

224

0

0

0

Squirrel monkey

0

0

0

0

0

1

0

0

0

0

0

7

0

0

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Cynomolgus monkey

0

0

0

0

0

3,002

0

0

0

451

0

3,279

0

0

0

Rhesus monkey

0

44

0

0

0

117

0

0

1

0

0

71

0

2

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

15

0

0

0

0

0

38

0

0

0

Baboons

0

0

0

0

0

14

0

0

0

0

0

32

0

0

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

12

0

0

0

0

0

9

0

0

0

Other mammals

Other mammals

102

140

0

0

0

1,352

28

0

0

99

1,533

18,525

0

0

0

Birds

Domestic fowl

3,895

39,674

680

0

21,217

24,920

466

0

6

82,107

8,485

43,144

255

25,169

40

Other birds

1,819

7,138

0

0

4,260

12,000

408

180

0

2,535

404

27,225

0

2,084

823

Reptiles

Reptiles

0

181

0

0

558

369

289

0

0

1,003

0

3,462

0

0

0

Amphibians

Rana

0

0

2,306

0

0

377

4

0

0

18

0

118

0

0

0

Xenopus

972

918

0

0

50

4,546

285

0

0

1,204

0

4,897

0

0

18

Other amphibians

912

323

0

0

531

2,652

47

0

0

1,996

0

742

0

0

0

Fish

Zebra fish

8,112

23,912

0

0

5,414

87,413

1,587

0

1,859

21,375

6,454

16,799

0

1,676

236

Other fish

4,630

24,027

0

0

74,861

94,210

15,606

0

16,346

43,480

11,729

268,074

0

1,174

9,787

Cephalopods

Cephalopods

0

0

0

0

0

0

0

0

33

20

0

1

0

0

0

Totals

Total

212,152

511,194

8,681

1,209

216,026

1,826,287

234,232

2,664

42,770

725,833

97,501

1,798,243

28,208

139,882

241,243

%

2.2

5.3

0.1

0

2.3

19.1

2.4

0

0.4

7.6

1

18.8

0.3

1.5

2.5

Table 2.2: All uses (first use and all subsequent reuses) of animals for research, testing, routine production and educational purposes by species and Member State (Part2) (2017)

IT

LT

LU

LV

MT

NL

PL

PT

RO

SE

SI

SK

UK

Total

%

Mammals

Rodents

Mice

347,844

1,718

5,572

3,332

0

194,144

89,191

36,126

7,975

195,193

4,508

5,547

1,104,940

5,756,121

60.1

Rats

117,541

391

96

1,795

0

91,099

28,873

3,135

4,367

19,301

226

7,619

234,781

1,164,167

12.1

Guinea-Pigs

14,357

15

0

0

0

5,816

5,235

0

792

409

0

1,036

22,560

146,037

1.5

Hamsters (Syrian)

277

0

0

0

0

1,035

150

0

150

34

0

0

1,126

12,723

0.1

Hamsters (Chinese)

0

0

0

0

0

12

0

0

0

0

0

0

0

187

0

Mongolian gerbil

0

0

0

0

0

0

120

0

0

0

0

9

311

5,385

0.1

Other rodents

647

0

0

0

0

736

8,108

140

0

5

0

0

2,327

25,452

0.3

Rabbits

Rabbits

19,325

13

0

0

0

9,764

820

36

504

1,574

135

226

10,444

364,431

3.8

Carnivores

Cats

0

0

0

0

0

200

0

0

0

104

0

11

288

3,338

0

Dogs

639

0

0

0

0

909

10

0

0

386

0

0

3,949

21,359

0.2

Ferrets

42

0

0

0

0

680

0

0

0

0

0

0

405

2,112

0

Other carnivores

0

0

0

0

0

270

130

0

0

140

0

0

244

2,514

0

Farm animals

Horses, donkeys and cross-breeds

17

0

0

0

0

173

73

0

2

41

2

0

10,600

13,624

0.1

Pigs

1,621

68

0

22

0

9,738

1,517

155

58

1,557

80

0

4,618

75,875

0.8

Goats

23

0

0

0

0

259

24

0

0

30

0

0

304

2,268

0

Sheep

192

15

0

0

0

558

1,301

30

209

35

28

2

47,929

65,527

0.7

Cattle

279

0

0

0

0

3,833

413

0

2

1,420

0

1

9,085

37,276

0.4

Non-human primates

Prosimians

0

0

0

0

0

0

0

0

0

0

0

0

0

173

0

Marmoset and tamarins

1

0

0

0

0

41

0

0

0

0

0

0

166

646

0

Squirrel monkey

0

0

0

0

0

0

0

0

0

0

0

0

0

8

0

Other species of new world monkeys (Ceboidea)

0

0

0

0

0

0

3

0

0

0

0

0

0

3

0

Cynomolgus monkey

569

0

0

0

0

42

0

0

0

2

0

0

2,662

10,007

0.1

Rhesus monkey

4

0

0

0

0

234

0

0

0

23

0

0

132

628

0

Vervets (Chlorocebus spp.)

0

0

0

0

0

0

0

0

0

0

0

0

0

53

0

Baboons

0

0

0

0

0

0

0

0

0

0

0

0

0

46

0

Other species of old world monkeys (Cercopithecoidea)

0

0

0

0

0

0

14

0

0

0

0

0

0

35

0

Other mammals

Other mammals

30

0

0

140

0

3,315

639

32

0

327

0

0

804

27,066

0.3

Birds

Domestic fowl

34,715

0

0

0

0

55,371

5,067

120

330

1,452

10

233

124,656

472,012

4.9

Other birds

420

26

0

0

0

18,322

6,566

56

23

11,269

0

59

6,729

102,346

1.1

Reptiles

Reptiles

0

0

0

0

0

294

314

0

0

0

0

0

92

6,562

0.1

Amphibians

Rana

0

0

0

0

0

9

20

0

230

308

0

0

108

3,498

0

Xenopus

401

0

0

0

0

438

0

0

0

261

0

0

7,453

21,443

0.2

Other amphibians

0

0

0

0

0

60

456

0

0

2,694

0

0

533

10,946

0.1

Fish

Zebra fish

19,508

0

19,849

0

0

51,676

950

912

0

19,341

0

0

217,110

504,183

5.3

Other fish

10,715

520

0

0

250

15,887

5,381

829

0

33,940

98

0

91,632

723,176

7.5

Cephalopods

Cephalopods

10

0

0

0

0

0

0

450

0

0

0

0

0

514

0

Totals

Total

569,177

2,766

25,517

5,289

250

464,915

155,375

42,021

14,642

289,846

5,087

14,743

1,905,988

9,581,741

100

%

5.9

0

0.3

0.1

0

4.9

1.6

0.4

0.2

3

0.1

0.2

19.9

100

Table 3.1: Uses of animals for the creation of new genetically altered animal lines in basic, translational and applied research by species, reuse and Member State1) (2017)

Reuse2)

AT

BE

CZ

DE

DK

EE

EL

ES

FI

FR

HR

HU

IE

IT

LU

NL

PL

PT

SE

SI

UK

Total

%

Mice

No

14,373

24,875

9,007

117,993

3,686

16

3,960

17,749

4,155

36,512

0

162

586

7,799

0

10,790

188

495

22,641

55

213,555

488,597

99.6

Yes

0

0

216

432

0

0

0

70

0

180

0

0

0

0

0

2

0

39

788

0

393

2,120

0.4

Total

14,373

24,875

9,223

118,425

3,686

16

3,960

17,819

4,155

36,692

0

162

586

7,799

0

10,792

188

534

23,429

55

213,948

490,717

100.0

Rats

No

0

222

2,112

3,396

0

72

0

48

5

3,346

0

0

0

510

0

9

109

0

0

0

131

9,960

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

222

2,112

3,396

0

72

0

48

5

3,346

0

0

0

510

0

9

109

0

0

0

131

9,960

100.0

Rabbits

No

0

0

0

17

0

0

0

0

0

306

0

152

0

0

0

0

0

0

0

0

0

475

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

17

0

0

0

0

0

306

0

152

0

0

0

0

0

0

0

0

0

475

100.0

Pigs

No

0

0

0

61

2

0

0

1

0

0

0

0

0

36

0

0

0

0

0

0

124

224

98.7

Yes

0

0

0

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

1.3

Total

0

0

0

64

2

0

0

1

0

0

0

0

0

36

0

0

0

0

0

0

124

227

100.0

Sheep

No

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

17

17

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

17

17

100.0

Marmoset and tamarins

No

0

0

0

10

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

10

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

10

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

10

100.0

Other mammals

No

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

61

0

0

0

0

61

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

61

0

0

0

0

61

100.0

Domestic fowl

No

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

647

647

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

647

647

100.0

Xenopus

No

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

250

250

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

250

250

100.0

Zebra fish

No

8,185

3,544

0

48,540

0

0

0

4,886

699

5,080

230

0

0

0

77

167

0

0

8,546

0

49,941

129,895

86.3

Yes

0

979

14,351

3,451

0

0

0

0

0

0

0

567

0

0

0

0

0

0

1,271

0

82

20,701

13.7

Total

8,185

4,523

14,351

51,991

0

0

0

4,886

699

5,080

230

567

0

0

77

167

0

0

9,817

0

50,023

150,596

100.0

Other fish

No

0

0

0

3,348

0

0

0

1,187

0

0

0

0

0

0

0

0

0

0

0

0

34

4,569

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

3,348

0

0

0

1,187

0

0

0

0

0

0

0

0

0

0

0

0

34

4,569

100.0

All Species

No

22,558

28,641

11,119

173,365

3,688

88

3,960

23,871

4,859

45,244

230

314

586

8,345

77

10,966

358

495

31,187

55

264,699

634,705

96.5

Yes

0

979

14,567

3,886

0

0

0

70

0

180

0

567

0

0

0

2

0

39

2,059

0

475

22,824

3.5

Total

22,558

29,620

25,686

177,251

3,688

88

3,960

23,941

4,859

45,424

230

881

586

8,345

77

10,968

358

534

33,246

55

265,174

657,529

100.0

Table notes:

1)Table includes only those Member States that have reported data for this purpose

2)Reuse “No” = numbers of animals used for the first time;

Reuse “Yes” = all subsequent reuses;

Total = numbers of all uses.

Table 3.2: Uses of animals for the maintenance of colonies of established genetically altered animal lines by species, reuse and Member State1) (2017)

Reuse2)

AT

BE

CZ

DE

DK

EE

ES

FI

FR

HR

IE

IT

LU

NL

PL

PT

SE

SK

UK

Total

%

Mice

No

28,632

2,249

0

61,184

29

394

38,443

215

69,742

96

473

2,485

0

1,057

501

9,447

1,659

540

346,497

563,643

100.0

Yes

0

11

0

129

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

141

0.0

Total

28,632

2,260

0

61,313

29

394

38,443

215

69,742

96

473

2,485

0

1,057

501

9,447

1,659

540

346,498

563,784

100.0

Rats

No

729

0

0

1,574

0

0

0

0

755

0

0

53

0

429

0

0

20

320

2,919

6,799

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

729

0

0

1,574

0

0

0

0

755

0

0

53

0

429

0

0

20

320

2,919

6,799

100.0

Dogs

No

0

0

0

0

0

0

0

0

10

0

0

0

0

0

0

0

0

0

0

10

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

0

0

0

0

0

10

0

0

0

0

0

0

0

0

0

0

10

100.0

Domestic fowl

No

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

367

367

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

367

367

100.0

Xenopus

No

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

195

195

49.7

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

197

197

50.3

Total

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

392

392

100.0

Zebra fish

No

0

0

0

2,272

0

0

14,759

0

0

0

0

0

247

181

0

368

0

0

52,401

70,228

99.1

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

612

612

0.9

Total

0

0

0

2,272

0

0

14,759

0

0

0

0

0

247

181

0

368

0

0

53,013

70,840

100.0

Other fish

No

0

0

0

116

0

0

0

0

0

0

0

0

0

0

0

0

0

0

524

640

100.0

Yes

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.0

Total

0

0

0

116

0

0

0

0

0

0

0

0

0

0

0

0

0

0

524

640

100.0

All Species

No

29,361

2,249

0

65,146

29

394

53,202

215

70,507

96

473

2,538

247

1,667

501

9,815

1,679

860

402,903

641,882

99.9

Yes

0

11

0

129

0

0

0

0

0

0

0

0

0

0

0

0

0

0

810

950

0.1

Total

29,361

2,260

0

65,275

29

394

53,202

215

70,507

96

473

2,538

247

1,667

501

9,815

1,679

860

403,713

642,832

100.0

Table notes:

1)Table includes only those Member States that have reported data for this purpose

2)Reuse “No” = numbers of animals used for the first time;

Reuse “Yes” = all subsequent reuses;

Total = numbers of all uses.

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