(a)

all authorisation decisions and authorised projects;

(b)

multiple generic projects, as provided for in Article 40(4) of Directive 2010/63/EU, categorised as one of the following types:

(c)

the authorisation decisions where the deadline of 40 days has been extended in accordance with Article 41(2) of Directive 2010/63/EU.

(a)

projects using non-human primates;

(b)

projects involving procedures classified as ‘severe’;

(c)

projects using non-human primates and involving procedures classified as ‘severe’;

(d)

other projects that are to undergo a retrospective assessment.

(a)

genetically normal animals not providing organs and/or tissues;

(b)

genetically normal animals providing organs and/or tissues;

(c)

GA animals providing organs and/or tissues;

(d)

genetically normal animals (wild type offspring) as a result of the creation of a new GA line;

(e)

animals from the maintenance of a GA line covering all GA and wild type offspring of both harmful and non-harmful phenotype.

(a)

animals that were genotyped using invasive methods;

(b)

animals from a harmful phenotype line that experienced adverse effect.

(a)

infringements;

(b)

administrative actions in response to infringements;

(c)

legal actions in response to infringements.

3.1.

Animals killed for organs and tissues, as well as sentinels, are excluded from the provision of annual statistical data, unless any of the following applies:

3.2.

Other animals killed for organs and tissues (those not reported in the annual statistics) are reported as part of the five-year implementation report in line with Annex II to this Decision.

4.1.

Animals that are bred and killed without being used in a procedure shall not be included in the annual statistical data apart from the following animals:

4.2.

For the purposes of point 4.1(b), an invasive method shall be a method which may cause the animal 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.

4.3.

The animals that are bred and killed without being used in a procedure shall be reported in accordance with Annex II of this Decision as part of the five-year implementation report.

11.1.

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

11.2.

Genetically altered animals shall be reported in any of the following cases:

11.3.

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

11.4.

Genetically normal animals (wild type offspring) produced as a result of creation of a new genetically altered line shall not be reported in annual statistics, unless the animal has been genotyped (genetic characterisation/tissue sampling) using an invasive method which was not carried out for the purposes of identification/marking of the animal. Genetically normal animals (wild type offspring) not reported in annual statistics are covered in the five-year implementation report as described in Annex II.

11.5.

In the category ‘Purposes’ as set out in Part A of this Annex, the animals used for the creation of a new genetically altered line shall be reported in the respective category for which the line is being created (generally expected to be ‘basic research’ or ‘translational and applied research’).

11.6.

A new strain or line of genetically altered animals is considered to be ‘established’ where transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.

11.7.

The welfare assessment will determine if the newly created line is expected to have an intended harmful phenotype and, if this is the case, the animals from this point onwards shall be reported under category ‘Maintenance of colonies of established genetically altered animals, not used in other procedures’ – or, if appropriate, in the other procedures they are being used for. Such animals include, amongst others, 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.

11.8.

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 no longer needs to be reported. Such animals include, amongst others, inducible and cre-lox lines, which require an active intervention for the harmful phenotype to be expressed.

11.9.

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

11.10.

All genetically altered animals which are used in other procedures (not for the creation or maintenance of a genetically altered line) shall be reported under their respective purposes (the same way as any non-genetically altered animal). These animals may or may not exhibit a harmful phenotype.

11.11.

Genetically altered animals, expressing a harmful phenotype, and killed for their organs and tissues, shall be reported under the respective primary purposes for which the organs/tissues were used.

2.1.1.

Each use of the animal shall be reported at the end of each procedure.

2.1.2.

Information on the place of birth and for non-human primates also the generation and information on whether the animal was obtained from a self-sustaining colony shall only be reported for naïve animals, that is to say animals used for the first time. For reused animals, this information is therefore not recorded.

2.1.3.

Any subsequent categories shall show the number of uses of animals in procedures. These numbers cannot be cross referenced with the total numbers of naïve animals.

2.1.4.

The actual suffering of the animal in the procedure shall be reported. In some cases this could be influenced by a previous use. However, the severity will not always increase in a subsequent use and in some cases may even decrease as a result (habituation). Therefore, the actual severity to be reported shall always be determined on a case-by-case basis taking account of any impact from previous uses.

2.2.1.

A single use is the use of one animal for a single scientific/experimental/educational/training purpose. A single use extends from the time when the first technique is applied to the animal until the completion of data collection, observations or achievement of educational objective. This is usually a single experiment, test or training of a technique.

2.2.2.

A single use may contain a number of steps (techniques) all necessarily related to achieve a single outcome and which require the use of the same animal.

2.2.3.

Examples of preparation for the purposes of continued use include:

2.2.4.

When the prepared animal is used in the procedure intended for it, the entire procedure, including any preparation (regardless of the location this has taken place) is reported at the end taking into account the severity associated with the preparation. For example, for the breeding of a genetically altered animal and its end use, the reporting shall take into account the severity associated with all the steps (for example, the effect of the phenotype, if expressed; genetic characterisation, if performed; and end use).

2.2.5.

The use of an animal is only reported once at the end of the complete procedure including where the preparatory steps described in point 2.2.3 and the end use have been carried out under separate projects.

2.2.6.

Where a prepared animal is not subsequently used for a scientific purpose, the establishment in which the animal is killed shall report the preparation as an independent use in the statistics as per the intended purpose, provided that the preparation of the animal has been above the threshold of minimum pain, suffering, distress and lasting harm. However, if this preparation concerns maintenance of a genetically altered animal line, the criteria by which animals are reported are provided for in section B.10.7.

2.2.7.

If the animal has been genotyped (genetic characterisation/tissue sampling) as part of a routine verification in a genetically altered breeding colony of an established line to confirm that the genotype has not varied from the intended genetic background and that animal is later used in another procedure, not requiring that particular genotype, that use is considered reuse and all such uses shall be reported separately in the statistics, that is to say:

(a)

animals used for the creation of a new line, carrying the genetic alteration but exhibiting no harmful phenotype;

(b)

genetically altered animals used in other procedures (not for creation or maintenance) but exhibiting no harmful phenotype.

(a)

animals used for the creation of a new line and exhibiting a harmful phenotype;

(b)

those used for maintaining an established line with an intended harmful phenotype and exhibiting a harmful phenotype;

(c)

genetically altered animals used in other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.

9.2.1.

Non-recovery – Animals, which have undergone a procedure that has been performed entirely under general anaesthesia and from which the animals have not recovered consciousness shall be reported as ‘Non-recovery’. This also includes the situation where animals have failed to recover consciousness from anaesthesia during the first step of a planned recovery procedure.

9.2.2.

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 shall be reported as ‘Mild’ This includes situations where there has been no significant impairment of the well-being or general condition of the animals.

This category shall also include 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 equivalent to that caused by the introduction of a needle in accordance with good veterinary practice with the exception of 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.

9.2.3.

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 cause moderate impairment of the well-being or general condition of the animals, shall be reported as ‘Moderate’.

9.2.4.

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’.

9.2.5.

If the ‘Severe’ classification is exceeded, whether pre-authorised or not, these animals and their use are to be reported as ‘Severe’. Commentary shall be added in the ‘Member State’ narrative in section C of this Annex. In such cases, the following shall be reported: species, numbers, whether prior exemption was authorised, details of the use and reasons why the ‘Severe’ classification was exceeded.

9.3.1.

With respect to animals that are found dead, severity shall be determined by reference to whether the death is the result of factors related to the procedure that the animal was undergoing. If not related (such as in the case of death due to deficiencies in equipment or environmental controls; inappropriate husbandry practices; unrelated disease and infections), the actual reported severity shall reflect the most severe effects experienced by that animal during the course of the procedure (excluding the experience preceding the death).

9.3.2.

If the death is related to the procedure, the actual reported severity shall be ‘severe’ unless an informed decision can be made that the severity can be assigned a lesser category.

10.1.1.

‘Basic research’ refers to 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 also 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.

10.1.2.

The animals used for the creation of a new genetically altered animal line (including crossing of two lines) intended to be used for the purposes of basic research (for example, developmental biology, immunology) shall be reported according to the purpose category they are being created for. In addition, they are reported in ‘Creation of a new genetic line – Animals used for the creation of a new genetically altered line/strain’.

10.1.3.

All animals carrying the genetic alteration shall be reported during the creation of a new line. Also animals used in creation, such as for superovulation, vasectomy and embryo implantation, are reported here. The reporting shall exclude non-genetically altered (wild type) offspring, unless that animal has been genotyped (genetic characterisation/tissue sampling) using an invasive method, which was not carried out for the purposes of identification/marking of the animal.

10.1.4.

A new strain or line of genetically altered animals is considered to be ‘established’ where transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.

10.2.1.

‘Translational and applied research’ refer to animals used for purposes as described in Article 5(b) and (c) excluding any regulatory use of animals (see point 10.3. below).

10.2.2.

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

10.2.3.

The animals used for the creation of a new genetically altered animal line intended to be used for the purposes of translational or applied research (for example, cancer research, vaccine development) shall be recorded according to the purpose they are being created for. In addition, they shall be reported in ‘Creation of a new genetic line – Animals used for the creation of a new genetically altered line/strain’.

10.2.4.

All animals carrying the genetic alteration shall be reported during the creation of a new line. Also animals used in creation, such as for superovulation, vasectomy and embryo implantation shall be reported here. The reporting shall exclude non-genetically altered (wild type) offspring.

10.2.5.

A new strain or line of genetically altered animals is considered to be ‘established’ where transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.

10.3.1.

‘Regulatory use’ covers 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.

10.3.2.

This includes tests carried out in respect of products/substances for which a regulatory submission was foreseen but ultimately not made, for instance because they were deemed unsuitable for the market by the developer and thus fail to reach the end of the development process.

10.3.3.

‘Routine production’ includes animals used in the manufacturing process of products such as antibodies and blood based products, for example, animals used in the manufacturing of serum-based medicinal products shall be included within this category.

10.3.4.

Efficacy testing during the development of new medicinal products is excluded and shall be reported under category ‘Translational and applied research’.

10.4.1.

This refers to studies aimed at investigating and understanding phenomena such as environmental pollution, loss of biodiversity, and epidemiology studies in wild animals.

10.4.2.

This excludes any regulatory use of animals for ecotoxicology purposes.

10.7.1.

This 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. The intended purpose which the line is being bred for is not recorded.

10.7.2.

This category also includes genetically altered animals during maintenance of an established line, irrespective of whether the line is of non-harmful or harmful phenotype, and either of the following applies:

10.7.3.

This category also includes re-derivation where it is done solely for scientific purposes (that is to say not to benefit health/welfare of colony) during maintenance of an established line, and animals used for embryo transfer and vasectomy.

10.7.4.

This excludes all animals needed for the creation of a new genetically altered line and those used in other procedures (that is to say other than creation/maintenance).

11.8.1.

Research that is not related to an organ/system listed above or is not organ/system specific.

11.8.2.

Particular attention needs to be paid before using category ‘other’ to ensure that none of the pre-defined categories could be used.

11.9.1.

Animals used for the production and maintenance of infectious agents, vectors (for example, arthropod feeding) and neoplasms, animals used for other biological material and animals used for the production of antibodies for the purposes of research, but excluding the growth of hybridoma cells by ascites method in the production of monoclonal antibodies (which is covered under category ‘Regulatory use and Routine production by product type’), shall be reported in the respective categories under ‘Basic research’ studies.

11.9.2.

Where more than one category applies to the purpose of the animal use, only the main purpose shall be reported.

12.9.1.

Animals used for the production and maintenance of infectious agents, vectors (for example, arthropod feeding) and neoplasms, animals used for other biological material and animals used for the production of antibodies for the purposes of translational and applied research, but excluding the growth of hybridoma cells by ascites method in the production of monoclonal antibodies (which is covered under category ‘Regulatory use and routine production by type’) shall be reported in the respective categories under ‘Translational and applied research’.

12.9.2.

Where more than one category applies to the purpose of the animal use, only the main purpose shall be reported.

13.4.1.

This 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.

13.4.2.

Where studies involve both mother and offspring, the mother shall be reported if she has been subject to a procedure above the threshold of minimum pain, suffering, distress and lasting harm. Offspring shall be reported if they are an integral part of the procedure such as in the case of end-points for reproduction.

13.5.1.

This covers the production of antibodies and blood products by established methods. This excludes immunisation of animals for subsequent hybridoma production carried out for the purposes of basic or applied and translational research within a given project, which shall be captured under basic or applied research under the appropriate category.

13.5.2.

The use of animals for antibody production for commercial purposes, including immunisation for the subsequent hybridoma production, shall be reported under ‘Routine production’/‘Monoclonal and polyclonal antibodies (excluding ascites method)’. All use of the ascites method for the culture of monoclonal antibodies shall be reported under ‘Routine production’/‘Monoclonal antibodies by ascites method only’.

(a)

general information on any changes in trends observed since the previous reporting period;

(b)

information on significant increase or decrease in use of animals in any of the specific areas and analysis of the reasons thereof;

(c)

information on any changes in trends in actual severities and analysis of the reasons thereof;

(d)

information on particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any;

(e)

further breakdown on the use of ‘other’ categories if a significant proportion of animal use is reported under this category;

(f)

information on the uses of animals in categories where a method or testing strategy for obtaining the results sought, not entailing the use of live animals, is recognised under the legislation of the Union;

(g)

details on cases where the ‘severe’ classification is exceeded, whether pre-authorised or not.

(a)

species;

(b)

numbers of animals;

(c)

whether exceeding the ‘severe’ classification was pre-authorised or not;

(d)

details of the use;

(e)

reasons why the ‘severe’ classification was exceeded.