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COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

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52013SC0497

COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union /* SWD/2013/0497 final */


COMMISSION STAFF WORKING DOCUMENT

Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

I.          INTRODUCTION

The objective of this report is to present statistical data on the number of animals used for scientific purposes in the Member States of the European Union during the year 2011(*) in accordance with provisions of Article 26 of Directive 86/609/EEC of 24 November 1986 [1] regarding the protection of animals used for experimental and other scientific purposes.

The first two statistical reports drafted in accordance with the provisions of the above mentioned directive which were published in 1994[2] and 1999[3], covering data on experimental animals collected in 1991 and 1996 respectively, allowed only a limited amount of statistical analysis due to the absence of a consistent system of reporting the data on the use of experimental animals. In 1997 an agreement was reached between the competent authorities of the Member States and the Commission to submit data for future reports under a format of eight harmonized tables. The Fifth Statistical report published in 2007[4] contained for the first time data collected in the 10 Member States which joined the EU in 2004. The Sixth Statistical Report published in 2010[5] gave an overview of the number of animals used in the year 2008 in 27 Member States.

This Seventh Statistical Report contains the results of the data collected by all 27 Member States in 2011 with the exception of one (France) which provided data from 2010.

The Commission Staff Working Document accompanies the Report from the Commission to the Council and the European Parliament – Seventh Report on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union. The report summarises the data and conclusions presented in this document.

(*) Except for one Member State reporting for 2010

II.          DATA SUBMITTED AND GENERAL ASSESSMENT

II.1.       Data submitted by the Member States

As in 2008 all 27 Member States submitted the data in the agreed format of the eight EU Tables, referred to as table 1 to 8 hereunder.  

A quality control check has been carried out on the set of data submitted for 2011 that is essentially governed by five criteria based on certain relationships between the data in the different tables.

– The first of these relationships concerns the total number of animals used by species of column 1.2 of table 1 and of column 2.10 of table 2. Since both tables concern the total of animals used by species the totals of the tables 1 and 2 should be identical.

– The second relationship concerns column 2.6 of table 2 'animals used for toxicological and other safety evaluation' which is broken down into types of products/endpoints in table 3; into Regulatory requirements in table 6; and into types of toxicological tests in table 7. Therefore, the totals of column 2.6 must be equal to the totals of tables 3, 6, 7 and in addition table 8 'type of tests versus products'.

– The third relationship is that the sum of column 2.4 and 2.5 of table 2 must be equal to the total of table 5.

– The fourth relationship exists between the total row of table 3 and the total column of table 8. Both the row and the column concern the total number of animals used for toxicological and other safety test by type of products/procedure and should therefore be equal.

– In the fifth relationship, the total row of table 7 should be equal to the total row of table 8.

The first and last two criteria have not been fully respected in the most recent collection of data by some Member States and could unfortunately not be corrected in time for the start of the analysis for this report. Despite these marginal errors, the data provided by the Member States give a consistent basis for a sound statistical analysis of all eight EU Tables.

II.2.       General assessment

Each Member State is requested, pursuant to Article 13 of Directive 86/609/EEC, to submit to the Commission the statistical data on the animals used for experimental and other scientific purposes. The data for this report covers the year 2011 with the exception of France which provided data from 2010.

Council Resolution 86/C331/02 of the representatives of the Governments of the Member States of the European Communities, meeting within the Council of 24 November 1986 regarding the protection of animals used for experimental and other scientific purposes[6] allowed the use of animals in experiments for education and training, but where the purposes of such experiments were not covered by the Directive, Member States according to the Resolution applied national provisions which are no less severe than those of the Directive. Therefore, when reporting a number of Member States have also included animals covered by the Resolution in the report.

It should be noted that this is the last time that animal use data has been collected in accordance with the requirements of Directive 86/609/EEC. This Directive has been replaced by Directive 2010/63/EU on the protection of animals used for scientific purposes, and the submission and publication of data have been completely revised with effect from 10 May 2013.

The first part of this report aims at providing a comprehensive overview on the numbers of animals used for various experimental purposes in the Community in 2011. The purposes of the use of animals have been analysed, and some of these purposes have been broken down further into more precise parameters. It also considers different legislative requirements regarding the use of experimental animals and the type of testing carried out on different species.

Due to differences in the reporting year and an increase in the number of Member States over the years, it is not possible to draw accurate quantitative conclusions on the evolution of the use of animals for experimental purposes in the EU. However, some trend comparisons have been made, and any significant changes in use have been highlighted in the report.

The second part of this report provides the individual data from the Member States together with the respective comments.

In the EU, the total number of animals used for experimental and other scientific purposes from the data collected in 2011 in accordance with the provision of the Directive for this report is just under 11,5 million (with data from France from 2010). This is a reduction of over half a million animals in the EU since the previous report covering the year 2008. The Member States contributing with a biggest net reduction include Belgium, France, Italy, Sweden and UK. In addition, credit should be given to some of the other Member States using smaller numbers of animals, however, with a significant drop in percentage terms.

As in previous reports rodents and rabbits represent 80% of the total number of animals used in the EU. Mice are by far the most commonly used species accounting for 61% of the total use, followed by rats with 14%.

The second most used group of animals was, as in previous years, cold-blooded animals which represent almost 12,5%. The third largest group of animals used was birds with 5,9% of the total use.

As stated in the previous three statistical reports no ‘Great Apes’ were used in experiments in the EU in 2011.

II.3.       Structure of the Report

The report is divided into two parts:

A           A global compilation and overview for the European Union of the statistical data of the Member States for 2011. A consolidated table has been computed on the basis of the data submitted and is presented at the end of each chapter. Each table is illustrated by a graphical presentation to give a more readable overview of the EU situation. As France submitted data from 2010 the totals used in this report are a mixture of years. Comparisons were nevertheless made on this basis since no other data were available. The numbering of tables and graphical presentation in Part A of the report are linked to the numbers of the EU tables and not to the numbering of the chapters of the report. 

B          Contains the data submitted by each Member State with Member State comments.         

PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2011

III.1.      Results of EU Table 1: Species and number of animals

Two types of information can be drawn from the data submitted in EU Table 1. The first relates to the total number of animals subdivided into 25 species used by the Member States. The second type of information relates to the place of origin of the animals used for experimental or other scientific purposes.

III.1.1.    The data on the total number of animals used in the Member States

Table 1.1 of this report presents the consolidated data on the number of animals used by species.

The total number of animals used in 2011 in the 27 Member States amounts to 11 481 521 animals. It is important to note that the total number of animals used in 2011 has decreased by over 500 000 (4.3%) animals in comparison to 2008.

III.1.2.    Treatment and interpretation of the data of table 1.1

In order to present an overall evaluation and subsequently a graphical analysis, animal species were grouped in classes. The result of this exercise is presented in table 1.2 at the end of this chapter. This grouping in table 1.2 allows an overview of the species used as is illustrated in figure 1.1.

It should also be pointed out that re-used animals are not included in the figures so that animals are not counted twice. 

Rodents together with rabbits represent 80% of the total number of animals used. Mice (60,9%) and rats (13,9%) are by far the most commonly used species.

The second most used group is represented by cold-blooded animals namely reptiles, amphibians and fish at 12,4%.

Birds is the next highest animal group used for experimental purposes at 5,9%.

The Artiodactyla and Perissodactyla group including horses, donkeys and cross-bred animals (Perissodactyla), pigs, goats, sheep and cattle (Artiodactyla) represent only 1,2% of the total number of animals used in the Member States.

Carnivores represent 0,25% of the total number of animals used and non-human primates represent 0,05% of the animals used in 2011.

III.1.3.    Comparison with the data of the previous reports

In this chapter, and the following chapters dealing with comparisons, it should be noted that in 1996, 2002, 2005, 2008 and for this report France reported data respectively for 1997, 2001, 2004, 2007 and 2010 which does not allow a rigorous comparison between data reported for each year. Nevertheless, assuming that fluctuations in the annual numbers of animals used per species in a country are limited, it is possible to make semi-quantitative estimates of the trends by comparing changes in proportions of use, expressed as a percentage.

Comparison between proportions of classes of animals used in 1996, 1999, 2002, 2005, 2008 and 2011

Class of species || 1996(*) || 1999 || 2002(**) || 2005(***) || 2008(****) || 2011(*****)

% Rodents-rabbits || 81,3 || 86,9 || 78,0 || 77,5 || 82,2 || 80,0

% Cold-blooded animals || 12,9 || 6,6 || 15,4 || 15, || 9,6 || 12,4

% Birds || || 4,7 || 5 || 5,4 || 6,4 || 5,9

% Artio and Perissodactyla || || 1,2 || 1,2 || 1,1 || 1,4 || 1,2

(*) 14 Member States reporting for 1996, one for 1997

(**) 14 Member States reporting for 2002, one for 2001

(***) 24 Member States reporting for 2005, one for 2004

(****) 27 Member States reporting for 2008, one for 2007

(*****) 27 Member States reporting for 2011, one for 2010

The percentage of rodents and rabbits shows some fluctuation, but remains close to 80%. The proportion of cold-blooded animals used in 1996, in 2002, in 2005 and 2008 is between 9,6 to 15%. However, in 1999 a much lower percentage of 6,6% was observed. In 2011, the use of cold-blooded animals increased from the last report but the percentage of animals used seems to fit perfectly into the cohort from 9,6 to 15% of the total number of animals.

Birds representing the third largest percentage of animals, seem to have reached a plateau in 2008.  For the first time in 2011 the number of birds has decreased (by over 88 000). The group of horses, donkeys and cross-bred animals (Artiodactyla) and pigs, goats, sheep and cattle (Perissodactyla) fluctuates at around 1%.

The effect of the inclusion of the data of new Member States since 2005 i.e. Bulgaria and Romania, did not lead to an increase in the total number of animals, on the contrary, there was already a decrease reported in 2008 and for 2011 the decrease has continued (by more than 500 000 animals). However, the use of some individual species has increased. This is displayed in Table 1.0 below.

Table 1.0 contains a comparison of the change that has taken place since 2008 for each species, expressed by number of animals per species, between EU 27 (data from 2011) and EU 27 (data from 2008) (first three columns) and in percentage per species (fourth column).

Table 1.0: Changes in species number and proportion between 2008 and 2011

Species || Number of animals in EU 27 2008 || Number of animals in EU 27 2011 || Change since 2008 || % change by species

1.a           Mice (Mus musculus) || 7122188 || 6999312 || -122876 || -1,73

1.b           Rats (Rattus norvegicus) || 2121727 || 1602969 || -518758 || -24,45

1.c           Guinea-Pigs (Cavia porcellus) || 220985 || 171584 || -49401 || -22,35

1.d           Hamsters (Mesocricetus ) || 32739 || 25251 || -7488 || -22,87

1.e           Other Rodents (other                  Rodentia) || 39506 || 28465 || -11041 || -27,95

1.f            Rabbits (Oryctolagus                 cuniculus) || 333213 || 358213 || 25000 || 7,50

1.g           Cats (Felis catus) || 4088 || 3713 || -375 || -9,17

1.h           Dogs (Canis familiaris) || 21315 || 17896 || -3419 || -16,04

1.i            Ferrets (Mustela putorius furo) || 3208 || 2540 || -668 || -20,82

1.j            Other Carnivores || 2853 || 4982 || 2129 || 74,62

1.k           Horses, donkeys and cross-                 breds (Equidae) || 5976 || 6686 || 710 || 11,88

1.l            Pigs (Sus) || 92813 || 77280 || -15533 || -16,74

1.m          Goats (Capra) || 3840 || 2907 || -933 || -24,30

1.n           Sheep (Ovis) || 30190 || 28892 || -1298 || -4,30

1.o           Cattle (Bos) || 33952 || 30914 || -3038 || -8,95

1.p           Prosimians (Prosimia) || 1261 || 83 || -1178 || -93,42

1.q           New World Monkeys                 (Ceboidea) || 904 || 700 || -204 || -22,57

1.r            Old World Monkeys                 (Cercopithecoidea) || 7404 || 5312 || -2092 || -28,25

1.s           Apes (Hominoidea) || 0 || 0 || 0 || 0,00

1.t            Other Mammals (other                 Mammalia) || 5704 || 7888 || 2184 || 38,29

1.u           Quail (Coturnix coturnix) || 9626 || 5614 || -4012 || -41,68

1.v           Other birds (other Aves) || 754485 || 669451 || -85034 || -11,27

1.w          Reptiles (Reptilia) || 4101 || 3824 || -277 || -6,75

1.x           Amphibians (Amphibia) || 61789 || 29583 || -32206 || -52,12

1.y           Fish (Pisces) || 1087155 || 1397462 || 310307 || 28,54

1.z           TOTAL || 12001022 || 11481521 || -519501 || -4,33

There is a clear increase in the total numbers of five species out of the 25 species reported. For other species a net decrease is observed.

The changes per species are reported in table 1.0 under the last column 'percentage change by species' and in the column 'change since 2008' reflecting the magnitude of the change.

The highest increase is noted for fish used in comparison to 2008 (310 307).

There has been a significant proportional increase in the number of rabbits since 2008 (25 000).

For species used in lower numbers (i.e. in the thousands range) there is an increase in the number of animals in the category other carnivores (2 129), horses, donkeys and cross-breds (710) and other mammals (2 184).

The largest decrease observed in 2011 for species used in greater numbers (i.e. in the millions range) is for rats with a reduction of more than 500 000 animals. In the same range there is also a reduction in the use of mice (122 876). There is also a significant reduction in the use of 'other birds' (more than 85 000) and guinea-pigs (49 401).

There is a clear decrease in the use of prosimians and non-human primates. The most notable proportional reduction is in the use of prosimians (1 178) which represents a decrease of 94%. The total number of new world monkeys is down from 904 in 2008 to 700 in 2011 (22,5%), and use of old world monkeys has also decreased from 7 404 to 5 312 (28%).

No use of great apes has been reported in EU since in 1999.

Member States submitted a break down of the category 'other', for the following species:

Other Rodents: gerbils, old world jerboas (Jaculus jaculus); chinchillas, beavers, ground squirrels, hamsters, grey dwarf hamsters (Cricetulus migratorius) and different species of mice.

Other Carnivores: wild-life species used for zoological and ecological studies e.g. foxes, badgers, seals, otters and fitchew.

Other Mammals: boars, bats and shrews, llamas, moles, European bison and red deer.

Other birds: mainly Japanese quail (coturnix japonica) and bob-white quail, poultry species, and zebra finches, canary, parakeet, parrot and farmed avian species for example, chickens (Gallus gallus domesticus).

Table 1.1: Total number of animals used for experimental purposes in the EU Member States

Data of 2011 (*)

Species || AT || BE || BG || CY || CZ || DK || ET || FI || FR || DE || EL || HU || IE || IT || LV || LT || LU || MT || NL || PL || PT || RO || SP || SK || SI || SE || UK || Totals

1.a.Mice || 153153 || 408883 || 3819 || 1328 || 72855 || 141991 || 26048 || 73503 || 1326274 || 1451046 || 24354 || 143755 || 248958 || 515946 || 6300 || 2131 || 470 || 0 || 237784 || 95115 || 24399 || 44575 || 634912 || 8747 || 11133 || 185913 || 1155920 || 6999312

1.b.Rats || 9026 || 89547 || 2569 || 0 || 30829 || 67159 || 2556 || 18586 || 252589 || 312740 || 2266 || 70873 || 10476 || 155136 || 4020 || 1297 || 32 || 0 || 98881 || 38171 || 11290 || 5161 || 126406 || 5327 || 393 || 35202 || 252437 || 1602969

1.c. Guinea-Pigs || 3797 || 24300 || 3700 || 0 || 3304 || 4672 || 72 || 11 || 35543 || 24258 || 39 || 9228 || 545 || 13784 || 0 || 177 || 0 || 0 || 5493 || 8943 || 4 || 6607 || 13749 || 645 || 48 || 1151 || 11514 || 171584

1.d. Hamsters || 125 || 2435 || 516 || 0 || 119 || 178 || 120 || 201 || 8210 || 4187 || || 88 || 0 || 517 || 0 || 0 || 0 || 0 || 3632 || 278 || 6 || 263 || 1492 || 0 || 0 || 881 || 2003 || 25251

1.e .Other Rodents || 64 || 421 || || || 1316 || 115 || 0 || 2682 || 224 || 4111 || || 0 || || 1946 || || || || 0 || 979 || 11710 || 74 || || 80 || 17 || 0 || 1483 || 3243 || 28465

1.f. Rabbits || 15633 || 54001 || 822 || 0 || 7677 || 3602 || 3 || 357 || 125913 || 87303 || 701 || 7567 || 715 || 8392 || 0 || 274 || 0 || 0 || 6293 || 2198 || 102 || 2195 || 21302 || 299 || 234 || 710 || 11920 || 358213

1.g.Cats || 14 || 630 || 8 || 0 || 181 || 0 || 0 || 454 || 569 || 585 || 19 || 34 || 120 || 0 || 0 || 0 || 0 || 0 || 174 || 480 || || 0 || 229 || 10 || 0 || 34 || 172 || 3713

1.h.Dogs || 75 || 490 || 0 || 0 || 1386 || 470 || 0 || 2805 || 3032 || 2474 || 4 || 675 || 473 || 408 || 9 || 0 || 0 || 0 || 692 || 229 || 20 || 0 || 1252 || 0 || 0 || 530 || 2872 || 17896

1.i Ferrets || 12 || 192 || 0 || 0 || 193 || 129 || 0 || 0 || 351 || 96 || || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 852 || 0 || || 0 || 87 || 0 || 0 || 76 || 552 || 2540

1.j. Other Carnivores || 0 || 0 || || || 45 || 197 || 0 || 656 || 0 || 262 || || 0 || || 0 || || || || 0 || 430 || 2149 || || || 245 || || 0 || 256 || 742 || 4982

1.k. Horses, donkeys and cross-breds || 128 || 54 || || || 595 || 67 || 40 || 23 || 373 || 1140 || || 9 || 238 || 34 || || || || 0 || 2371 || 766 || || 14 || 346 || || 7 || 107 || 374 || 6686

1.l.Pigs || 1553 || 2622 || 110 || || 2283 || 8694 || 325 || 681 || 7364 || 15090 || 390 || 1278 || 286 || 2486 || || 19 || || 0 || 14686 || 1147 || 474 || 2 || 11046 || 84 || 13 || 2277 || 4370 || 77280

1.m Goats || 60 || 86 || || || 106 || 74 || 0 || 40 || 710 || 394 || || 0 || 39 || 34 || || || || 0 || 284 || 396 || 99 || || 455 || || 0 || 13 || 117 || 2907

1.n.  Sheep || 683 || 542 || 320 || || 1147 || 191 || 0 || 684 || 5491 || 3287 || 8 || 160 || 348 || 243 || || || || 0 || 2600 || 379 || 29 || 131 || 2790 || 14 || 4 || 285 || 9556 || 28892

1.o.Cattle || 1582 || 810 || || || 783 || 513 || 6750 || 63 || 2362 || 4300 || || 5 || 1700 || 27 || || || || 0 || 2383 || 3489 || || 3 || 1464 || 0 || 0 || 370 || 4310 || 30914

1.p. Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 83 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 83

1.q. NW Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 163 || 191 || || 0 || 0 || 79 || 0 || 0 || 0 || 0 || 22 || 0 || || 0 || 1 || 0 || 0 || 0 || 244 || 700

1.r. OW Monkeys || 0 || 20 || 0 || 0 || 30 || 0 || 0 || 0 || 1564 || 1579 || || 7 || 0 || 371 || 0 || 0 || 0 || 0 || 184 || 0 || || 0 || 342 || 0 || 0 || 0 || 1215 || 5312

1.s Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.t.Other Mammals || 0 || 64 || || || 2838 || 32 || 20 || 17 || 2 || 1154 || || 0 || 480 || 184 || || || || 10 || 41 || 594 || || || 56 || || 0 || 1625 || 771 || 7888

1.u.Quail || 0 || 651 || 0 || 0 || 230 || 0 || 0 || 0 || 122 || 2821 || || 235 || 0 || 4 || 0 || 0 || 0 || 0 || 68 || 1247 || || 9 || 105 || 88 || 0 || 0 || 34 || 5614

1.v.Other birds || 1940 || 16493 || 1080 || || 170261 || 3245 || 701 || 4426 || 71821 || 31271 || || 36304 || 503 || 29305 || || 20 || || 0 || 99354 || 13615 || 433 || 1196 || 21341 || 486 || 0 || 2804 || 162852 || 669451

1.w.Reptiles || 0 || 459 || || || 1258 || 237 || 0 || 15 || 74 || 1011 || || 0 || || 239 || || || || 0 || 133 || 15 || || || 0 || || 0 || 0 || 383 || 3824

1.x Amphibians || 176 || 2113 || 4285 || || 3989 || 115 || 0 || 73 || 3279 || 4453 || 220 || 725 || 21 || 894 || || 149 || || 0 || 1247 || 964 || 25 || || 1097 || || 0 || 1216 || 4542 || 29583

1.y.Fish || 3267 || 60266 || 30 || || 52771 || 51159 || 4400 || 30766 || 354039 || 119949 || || 5236 || 88 || 51786 || || || || 0 || 36034 || 100275 || 9601 || || 61330 || || 42 || 36108 || 420315 || 13974622

1.z.TOTAL || 191288 || 665079 || 17259 || 1328 || 354196 || 282840 || 41035 || 136043 || 2200152 || 2073702 || 28001 || 276179 || 264990 || 781815 || 10329 || 4067 || 502 || 10 || 514617 || 282160 || 46556 || 60156 || 900127 || 15717 || 11874 || 271041 || 2050458 || 11481521

(*) France is reporting for 2010

Table 1.2: Classes of animals used for experimental purposes in the EU Member States

Data of 2011 (*)

Species || AT || BE || BG || CY || CZ || DK || ET || FI || FR || DE || EL || HU || IE || IT || LV || LT || LU || MT || NL || PL || PT || RO || SP || SK || SI || SE || UK || Totals

Mice || 153153 || 408883 || 3819 || 1328 || 72855 || 141991 || 26048 || 73503 || 1326274 || 1451046 || 24354 || 143755 || 248958 || 515946 || 6300 || 2131 || 470 || 0 || 237784 || 95115 || 24399 || 44575 || 634912 || 8747 || 11133 || 185913 || 1155920 || 6999312

Rats || 9026 || 89547 || 2569 || 0 || 30829 || 67159 || 2556 || 18586 || 252589 || 312740 || 2266 || 70873 || 10476 || 155136 || 4020 || 1297 || 32 || 0 || 98881 || 38171 || 11290 || 5161 || 126406 || 5327 || 393 || 35202 || 252437 || 1602969

Guinea-Pigs || 3797 || 24300 || 3700 || 0 || 3304 || 4672 || 72 || 11 || 35543 || 24258 || 39 || 9228 || 545 || 13784 || 0 || 177 || 0 || 0 || 5493 || 8943 || 4 || 6607 || 13749 || 645 || 48 || 1151 || 11514 || 171584

Hamsters+ other rodents || 189 || 2856 || 516 || 0 || 1435 || 293 || 120 || 2883 || 8434 || 8298 || 0 || 88 || 0 || 2463 || 0 || 0 || 0 || 0 || 4611 || 11988 || 80 || 263 || 1572 || 17 || 0 || 2364 || 5246 || 53716

Rabbits || 15633 || 54001 || 822 || 0 || 7677 || 3602 || 3 || 357 || 125913 || 87303 || 701 || 7567 || 715 || 8392 || 0 || 274 || 0 || 0 || 6293 || 2198 || 102 || 2195 || 21302 || 299 || 234 || 710 || 11920 || 358213

Cold-blooded animals (1) || 3443 || 62838 || 4315 || 0 || 58018 || 51511 || 4400 || 30854 || 357392 || 125413 || 220 || 5961 || 109 || 52919 || 0 || 149 || 0 || 0 || 37414 || 101254 || 9626 || 0 || 62427 || 0 || 42 || 37324 || 425240 || 1430869

Birds (2) || 1940 || 17144 || 1080 || 0 || 170491 || 3245 || 701 || 4426 || 71943 || 34092 || 0 || 36539 || 503 || 29309 || 0 || 20 || 0 || 0 || 99422 || 14862 || 433 || 1205 || 21446 || 574 || 0 || 2804 || 162886 || 675065

Artio+Perissodactyla (3) || 4006 || 4114 || 430 || 0 || 4914 || 9539 || 7115 || 1491 || 16300 || 24211 || 398 || 1452 || 2611 || 2824 || 0 || 19 || 0 || 0 || 22324 || 6177 || 602 || 150 || 16101 || 98 || 24 || 3052 || 18727 || 146679

Carnivores || 101 || 1312 || 8 || 0 || 1805 || 796 || 0 || 3915 || 3952 || 3417 || 23 || 709 || 593 || 408 || 9 || 0 || 0 || 0 || 2148 || 2858 || 20 || 0 || 1813 || 10 || 0 || 896 || 4338 || 29131

Prosimians+monkeys+apes || 0 || 20 || 0 || 0 || 30 || 0 || 0 || 0 || 1810 || 1770 || 0 || 7 || 0 || 450 || 0 || 0 || 0 || 0 || 206 || 0 || 0 || 0 || 343 || 0 || 0 || 0 || 1459 || 6095

Other Mammals || 0 || 64 || || || 2838 || 32 || 20 || 17 || 2 || 1154 || || 0 || 480 || 184 || || || || 10 || 41 || 594 || || || 56 || || 0 || 1625 || 771 || 7888

TOTAL || 191288 || 665079 || 17259 || 1328 || 354196 || 282840 || 41035 || 136043 || 2200152 || 2073702 || 28001 || 276179 || 264990 || 781815 || 10329 || 4067 || 502 || 10 || 514617 || 282160 || 46556 || 60156 || 900127 || 15717 || 11874 || 271041 || 2050458 || 11481521

Species || AT || BE || BG || CY || CZ || DK || ET || FI || FR || DE || EL || HU || IE || IT || LV || LT || LU || MT || NL || PL || PT || RO || SP || SK || SI || SE || UK || Totals

Mice || 80,06 || 61,48 || 22,13 || 100,00 || 20,57 || 50,20 || 63,48 || 54,03 || 60,28 || 69,97 || 86,98 || 52,05 || 93,95 || 65,99 || 60,99 || 52,40 || 93,63 || 0,00 || 46,21 || 33,71 || 52,41 || 74,10 || 70,54 || 55,65 || 93,76 || 68,59 || 56,37 || 60,96

Rats || 4,72 || 13,46 || 14,88 || 0,00 || 8,70 || 23,74 || 6,23 || 13,66 || 11,48 || 15,08 || 8,09 || 25,66 || 3,95 || 19,84 || 38,92 || 31,89 || 6,37 || 0,00 || 19,21 || 13,53 || 24,25 || 8,58 || 14,04 || 33,89 || 3,31 || 12,99 || 12,31 || 13,96

Guinea-Pigs || 1,98 || 3,65 || 21,44 || 0,00 || 0,93 || 1,65 || 0,18 || 0,01 || 1,62 || 1,17 || 0,14 || 3,34 || 0,21 || 1,76 || 0,00 || 4,35 || 0,00 || 0,00 || 1,07 || 3,17 || 0,01 || 10,98 || 1,53 || 4,10 || 0,40 || 0,42 || 0,56 || 1,49

Hamsters + other rodents || 0,10 || 0,43 || 2,99 || 0,00 || 0,41 || 0,10 || 0,29 || 2,12 || 0,38 || 0,40 || 0,00 || 0,03 || 0,00 || 0,32 || 0,00 || 0,00 || 0,00 || 0,00 || 0,90 || 4,25 || 0,17 || 0,44 || 0,17 || 0,11 || 0,00 || 0,87 || 0,26 || 0,47

Rabbits || 8,17 || 8,12 || 4,76 || 0,00 || 2,17 || 1,27 || 0,01 || 0,26 || 5,72 || 4,21 || 2,50 || 2,74 || 0,27 || 1,07 || 0,00 || 6,74 || 0,00 || 0,00 || 1,22 || 0,78 || 0,22 || 3,65 || 2,37 || 1,90 || 1,97 || 0,26 || 0,58 || 3,12

Cold-blooded animals (1) || 1,80 || 9,45 || 25,00 || 0,00 || 16,38 || 18,21 || 10,72 || 22,68 || 16,24 || 6,05 || 0,79 || 2,16 || 0,04 || 6,77 || 0,00 || 3,66 || 0,00 || 0,00 || 7,27 || 35,89 || 20,68 || 0,00 || 6,94 || 0,00 || 0,35 || 13,77 || 20,74 || 12,46

Birds (2) || 1,01 || 2,58 || 6,26 || 0,00 || 48,13 || 1,15 || 1,71 || 3,25 || 3,27 || 1,64 || 0,00 || 13,23 || 0,19 || 3,75 || 0,00 || 0,49 || 0,00 || 0,00 || 19,32 || 5,27 || 0,93 || 2,00 || 2,38 || 3,65 || 0,00 || 1,03 || 7,94 || 5,88

Artio+Perissodactyla (3) || 2,09 || 0,62 || 2,49 || 0,00 || 1,39 || 3,37 || 17,34 || 1,10 || 0,74 || 1,17 || 1,42 || 0,53 || 0,99 || 0,36 || 0,00 || 0,47 || 0,00 || 0,00 || 4,34 || 2,19 || 1,29 || 0,25 || 1,79 || 0,62 || 0,20 || 1,13 || 0,91 || 1,28

Carnivores || 0,05 || 0,20 || 0,05 || 0,00 || 0,51 || 0,28 || 0,00 || 2,88 || 0,18 || 0,16 || 0,08 || 0,26 || 0,22 || 0,05 || 0,09 || 0,00 || 0,00 || 0,00 || 0,42 || 1,01 || 0,04 || 0,00 || 0,20 || 0,06 || 0,00 || 0,33 || 0,21 || 0,25

Prosimians+monkeys+apes || 0,00 || 0,00 || 0,00 || 0,00 || 0,01 || 0,00 || 0,00 || 0,00 || 0,08 || 0,09 || 0,00 || 0,00 || 0,00 || 0,06 || 0,00 || 0,00 || 0,00 || 0,00 || 0,04 || 0,00 || 0,00 || 0,00 || 0,04 || 0,00 || 0,00 || 0,00 || 0,07 || 0,05

Other Mammals || 0,00 || 0,01 || 0,00 || 0,00 || 0,80 || 0,01 || 0,05 || 0,01 || 0,00 || 0,06 || 0,00 || 0,00 || 0,18 || 0,02 || 0,00 || 0,00 || 0,00 || 100,00 || 0,01 || 0,21 || 0,00 || 0,00 || 0,01 || 0,00 || 0,00 || 0,60 || 0,04 || 0,07

 TOTAL || 100,00 || 100,00 || 100,00 || 100,0 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,0 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00

|| FR(*) France reporting for 2010 ||

|| (1) Reptiles + amphibians + fish ||

|| (2) Quails and Other birds ||

|| (3) Horses, donkeys, and cross-breds + pigs + goats and sheep + cattle ||

|| (4) Cats + dogs + ferrets + other carnivores ||

III.2.      Results of EU Table 1: Origin of animals used

III.2.1.    The data on the origin of the species

The consolidated results of EU Table 1 on the origin of some selected species used for experimental purposes in the 27 Member States are reported in table 1.3 at the end of this chapter. The consolidated table 1.3 only indicates species for which the origin must be reported.

In addition, EU Table 1 contains information on the number of animals re-used in experiments.

III.2.2.    Treatment and interpretation of the data

The data of column 1.3 and 1.4 of table 1.3 of this report have been grouped to represent animals coming from the European Union.

Figure 1.2 represents the percentage of animals from the reported origin versus the species.

The chart indicates that the majority of species used in 2011 originate from EU breeding centres.  However, certain species such as cats, dogs, ferrets and old world monkeys originated from both EU and non-EU breeding centres.

III.2.3.    Comparison with data of the previous year

The general pattern shown in figure 1.2 on the origin of species remains rather similar to that of previous reports, with clear preference for animals which are bred in the EU. There is an increase in the use of dogs of EU origin from 72% to 85%, ferrets from 71% to 76% and old world monkeys from 54% to 66%. However, there is a decrease in use of new world monkeys from 99% to 92% and quails from 96% to 87% bred in the EU.

Table 1.3: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Data of 2011 (*)

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6  Animals coming from other origins || 1.7 Re-used animals ||

1.a. Mice (Mus musculus) || 6999312 || 5651922 || 900047 || 274313 || 173030 || 3768 ||

1.b. Rats (Rattus norvegicus) || 1602969 || 1253176 || 322045 || 13051 || 14697 || 3035 ||

1.c. Guinea-Pigs (Cavia porcellus) || 171584 || 120124 || 47311 || 3922 || 227 || 962 ||

1.d. Hamsters (Mesocricetus ) || 25251 || 18626 || 4676 || 0 || 1949 || 54 ||

1.f. Rabbits (Oryctolagus cuniculus) || 358213 || 336922 || 17009 || 1200 || 3082 || 15958 ||

1.g. Cats (Felis catus) || 3713 || 2299 || 379 || 34 || 1001 || 1181 ||

1.h. Dogs (Canis familiaris) || 17896 || 12246 || 3025 || 292 || 2333 || 4178 ||

1.i. Ferrets (Mustela putorius furo) || 2540 || 1035 || 893 || 40 || 572 || 64 ||

1.p. Prosimians (Prosimia) || 83 || 83 || 0 || 0 || 0 || 33 ||

1.q. New World Monkeys (Ceboidea) || 700 || 630 || 19 || 0 || 51 || 322 ||

1.r. Old World Monkeys (Cercopithecoidea) || 5312 || 1698 || 1813 || 5 || 1796 || 1492 ||

1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 ||

1.u. Quail (Coturnix coturnix) || 5614 || 4914 || 0 || 0 || 700 || 0 ||

1.z. TOTAL || 9193187 || 7403665 || 1297217 || 292857 || 199445 || ||

* France reporting for 2010

Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling this column

Note 2: Only species for which the origin has to be reported are included in this table.

Note 3: The number of re-used animals in column 1.7 should be excluded from the total in column 1.2.

III.3.      Results of EU Table 2: Purposes of the experiments

III.3.1.    The data on purposes of the experiments

The consolidated data on purposes of the experiments of the 27 Member States are presented in table 2.1 at the end of this chapter.

III.3.2.    Treatment and interpretation of the data

Table 2.2 presents the results of the consolidated data of the purposes of the procedures carried out in the 27 Member States in 2011. In order to facilitate the presentation of results some species and some purposes were grouped in table 2.2.

The percentage of the number of animals used for selected purposes is presented in figure 2.1.

               

More than 60% of animals were used for research and development in the fields of human medicine, veterinary medicine, dentistry and in biological studies of fundamental nature.

Production and quality control of products and devices in human medicine, veterinary medicine and dentistry required the use of 14% of the total number of animals.

Toxicological and other safety evaluation represents 8,75% of the total number of animals used for experimental purposes.

Other purposes of procedures represents 9% of the total number of animals and covers a wide range of experiments such as virology, immunology for production of monoclonal and polyclonal antibodies, physiology of foetal-maternal interaction in mouse gene transgensis, oncological treatment, pharmaceutical research and development, combined drug testing and genetics.

III.3.3.    Comparison with the data of the previous report

The comparison aims to detect changes in trends rather than draw formal conclusions. The most significant change since 2008 is that the number of animals used for research and development for human medicine, dentistry and veterinary medicine has dropped, as it did between 2005 and 2008. This time the drop is from 22,8% to 18,8% (in terms of animal numbers the decrease is 575 518 animals). There is a reduction of more than 62 000 fish and 41 500 'other birds' whereas the percentage of animals used for fundamental biological research has increased sharply from 38% to 46% (715 519 animals). Both fundamental biological research and research and development in human and veterinary medicine are the areas using by far the highest number of animals in the EU.

The number of animals used for toxicological and other safety evaluation amounts to 8,75% of the total. This represents 1 004 873 animals in this report.

The decrease in the numbers of animals used for toxicological and other safety evaluations since the report of 2008 is modest but represents nevertheless 37 280 animals.

The percentage of animals used for toxicology and safety evaluation was 9.9% in 2002, 8,2% in 2005, 8,7% in 2008 and 8,75% for this report which indicates a trend of stability for this area of use.

The number of animals used for production and quality control of devices for medicine, veterinary medicine and dentistry has gone down by approximately 192 000.  In spite of the overall decrease, the use of rabbits has increased by more than 81 000 animals for production and quality control of products and devices for human medicine and dentistry.

Further substantial increases since 2008 have been observed for mice (521 000) and fish (324 000) used in larger numbers for fundamental biological studies. There is also an increase in the use of fish (above 83 000) and birds (above 10 000) for 'other experiments'.

Regarding the increase of mice for biological studies of fundamental nature, Member States indicated that it was due to an increase in developmental assays and research using transgenic mice as specific models for e.g. ocular research, bone metabolism and fertility. The type of studies include LD50, ED50, potency testing and immunogenicity testing, studies in the area of neuroscience, of immunology, studies on physiopathological mechanisms of tumours and research to gain experience for the determination of mechanisms of action of diseases for therapeutic purposes.

The increase use of fish in area of fundamental research was attributed to studies on fish production, genetics, bio-molecular studies, cancer research, physiopathology and diagnosis. Fish have also been used for neurology, cardiovascular studies and in selection according to bioenergetic properties of their cardiac cells.

Fish increase in the category of 'other experiments' was attributed to single testing of biocides and to telemetric monitoring of some common species in the environment. Fish are also exclusively used under this heading by some Member States for vaccine studies.

Table 2.2 Number of animals used for selected purposes versus species

Species || Biological studies of a fundamental nature || Research, development and quality control of products and devices for human medicine and dentistry and for veterinary medicine || Toxicological and other safety evaluations (including safety evaluation of products) || Diagnosis of disease || Education and training || Other || Total

Mice || 3602370 || 2350205 || 464850 || 135042 || 82167 || 364381 || 6999015

Rats || 491345 || 725109 || 272581 || 18295 || 48152 || 47589 || 1603266

Other rodents || 36159 || 145153 || 28569 || 4527 || 4234 || 6658 || 225300

Rabbits || 12648 || 253488 || 23185 || 6083 || 2068 || 60741 || 358213

Carnivores || 8733 || 8706 || 7873 || 1905 || 1149 || 798 || 29164

Artio+Perissodactyla || 51876 || 48240 || 5221 || 7558 || 14297 || 19454 || 146646

Prosimians+monkeys+apes || 631 || 1375 || 3435 || 0 || 209 || 445 || 6095

Other mammals || 6822 || 773 || 179 || 53 || 26 || 35 || 7888

Birds || 294768 || 191575 || 17202 || 7480 || 3025 || 161015 || 675065

Cold-blooded animals || 785221 || 31373 || 181778 || 4314 || 24654 || 403529 || 1430869

TOTAL || 5290573 || 3755997 || 1004873 || 185257 || 179981 || 1064645 || 11481521

Figure 2.2 presents the number of animals used for selected purposes by classes of species.

The highest number of mice and rats used is attributed to biological studies of a fundamental nature and research, development and quality control of products and devices for medicine, dentistry and veterinary medicine. There has been an increase in the number of cold-blooded animals (essentially fish) used for other purposes and also for biological studies of fundamental nature since 2008.

Table 2.1: Number of animals used in experiments for selected purposes Purposes versus species data of 2011*

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10. Total

1.a.      Mice (Mus musculus) || 3602370 || 1458291 || 781514 || 110400 || 464850 || 135042 || 82167 || 364381 || 6999015

1.b.     Rats (Rattus norvegicus) || 491345 || 549341 || 157145 || 18623 || 272581 || 18295 || 48152 || 47589 || 1603266

1.c.     Guinea-Pigs (Cavia porcellus) || 8426 || 25777 || 86142 || 16350 || 26722 || 2067 || 3293 || 2807 || 171584

1.d.     Hamsters (Mesocricetus ) || 5605 || 8230 || 125 || 5876 || 1547 || 408 || 440 || 3020 || 25251

1.e.     Other Rodents (other Rodentia) || 22128 || 2653 || 0 || 0 || 300 || 2052 || 501 || 831 || 28465

1.f.     Rabbits (Oryctolagus cuniculus) || 12648 || 19434 || 212043 || 22011 || 23185 || 6083 || 2068 || 60741 || 358213

1.g.     Cats (Felis catus) || 855 || 885 || 81 || 223 || 325 || 981 || 169 || 194 || 3713

1.h.     Dogs (Canis familiaris) || 3715 || 4671 || 65 || 927 || 7488 || 458 || 351 || 221 || 17896

1.i.      Ferrets (Mustela putorius furo) || 927 || 1223 || 86 || 4 || 28 || 9 || 79 || 217 || 2573

1.j.     Other Carnivores (other Carnivora) || 3236 || 0 || 0 || 541 || 32 || 457 || 550 || 166 || 4982

1.k.    Horses, donkeys and cross-breds (Equidae) || 1449 || 868 || 235 || 2522 || 122 || 902 || 168 || 387 || 6653

1.l.     Pigs (Sus) || 24084 || 20806 || 839 || 6841 || 3537 || 3067 || 10022 || 8084 || 77280

1.m.   Goats (Capra) || 783 || 535 || 159 || 6 || 8 || 187 || 358 || 871 || 2907

1.n.    Sheep (Ovis) || 9816 || 2643 || 4250 || 2126 || 746 || 1854 || 1206 || 6251 || 28892

1.o.    Cattle (Bos) || 15744 || 3228 || 251 || 2931 || 808 || 1548 || 2543 || 3861 || 30914

1.p.     Prosimians (Prosimia) || 83 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 83

1.q.     New World Monkeys (Ceboidea) || 244 || 221 || 79 || 0 || 44 || 0 || 0 || 112 || 700

1.r.     Old World Monkeys (Cercopithecoidea) || 304 || 937 || 138 || 0 || 3391 || 0 || 209 || 333 || 5312

1.s.    Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.t.     Other Mammals (other Mammalia) || 6822 || 531 || 4 || 238 || 179 || 53 || 26 || 35 || 7888

1.u.    Quail (Coturnix coturnix) || 1591 || 0 || 0 || 0 || 3094 || 9 || 80 || 840 || 5614

1.v.    Other birds (other Aves) || 293177 || 36178 || 16855 || 138542 || 14108 || 7471 || 2945 || 160175 || 669451

1.w.    Reptiles (Reptilia) || 3202 || 98 || 0 || 0 || 0 || 412 || 111 || 1 || 3824

1.x.     Amphibians (Amphibia) || 16489 || 946 || 0 || 0 || 2695 || 5 || 9127 || 321 || 29583

1.y.     Fish (Pisces) || 765530 || 20692 || 0 || 9637 || 179083 || 3897 || 15416 || 403207 || 1397462

1.z.     TOTAL || 5290573 || 2158188 || 1260011 || 337798 || 1004873 || 185257 || 179981 || 1064645 || 11481521

(*) France is reporting for 2010

                                                                                                                                                                                          

III.4.      Results of EU Table 3: Toxicological and safety evaluation by type of product/endpoint

III.4.1.    The data on toxicological and safety evaluation by type of product/endpoint

The consolidated table giving the number of animals used for toxicological and other safety evaluation of products (EU Table 3) in 27 Member States in 2011 is presented in table 3 at the end of this chapter. In this table the number of animals used for toxicological or other safety evaluation is broken down into types of products for which testing was required.

The percentage of the number of animals used for different types of product is presented in figure 3.

III.4.2.    Treatment and interpretation of the data

The number of animals used for toxicological and other safety evaluation for different products, or for testing potential contaminants to the environment amounts to 1 004 873 which represents only 8,75% of the total number of animals used for scientific purposes in 2011 (see table 2.1, column 2.6).

Toxicological or other safety evaluations are split according to the type of sector for which they are intended. The percentage of animals used for toxicological evaluation of three groups of products/substances, i.e. additives in food for human consumption, cosmetics and household products, is very small (0,35%) when compared to the other product groups.

Products or devices used for human medicine, veterinary medicine and dentistry represents 39,8% of the animals used for toxicological or other safety evaluations.

The group of products/substances falling under the scrutiny of Member States authorities concerned with safety of health and of the environment by chemical products, such as industrial chemicals and pesticides, used 15,9% of the animals for toxicological and other safety evaluations.

There is little change with regard to the number of animals used for toxicological tests for products intended for industry and for agriculture in comparison to 2008, but there is a net increase of the number of animals used for potential contaminants of the environment. The increase is from above 65 000 to approximately 92 000.

A significant decrease has been observed in the number of animals used for testing food for animal consumption in comparison to 2008 from 54 000 to 4 600 which is more than a ten-fold decrease but also for cosmetics and toiletries where the decrease is from 1 960 to 90 animals. This is important to highlight as there is a testing ban in the EU for cosmetics and cosmetic ingredients in place since 2009.

There is, however, a substantial increase in the number of animals used for tests for 'other toxicological or safety evaluations' from 223 000 to 345 000 animals (roughly 122 000 animals which represent an increase of 54%). An increase was also observed in the 2008 report. Member States reported that under this heading, animals are used in metabolic studies and preclinical research, testing substances and products in human and veterinary medicine and in teratology studies on. They are also used in toxicity test to aquatic vertebrates not included in other categories, in LD50, ED50, pyrogen testing, and testing for algae biotoxins and other foodstuff contaminants.

Table 3: Number of animals used in toxicological and other safety evaluation Products versus species

Data of 2011*

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contaminants in the general environment which do not appear in other columns || 3.10 Other toxicological or safety evaluations || 3.11 Total

1.a.        Mice (Mus musculus) || 140441 || 15395 || 20073 || 40 || 40 || 652 || 1156 || 1910 || 285003 || 464710

1.b.        Rats (Rattus norvegicus) || 146109 || 35867 || 47684 || 804 || 50 || 1502 || 196 || 4323 || 36186 || 272721

1.c.        Guinea-Pigs (Cavia porcellus) || 19132 || 2180 || 872 || 76 || 0 || 0 || 7 || 0 || 4455 || 26722

1.d.        Hamsters (Mesocricetus ) || 1121 || 73 || 151 || 8 || 0 || 0 || 0 || 0 || 194 || 1547

1.e.        Other Rodents (other Rodentia) || 70 || 48 || 0 || 0 || 0 || 0 || 0 || 0 || 182 || 300

1.f.        Rabbits (Oryctolagus cuniculus) || 14616 || 2012 || 2373 || 49 || 0 || 0 || 16 || 4 || 4115 || 23185

1.g.        Cats (Felis catus) || 325 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 325

1.h.        Dogs (Canis familiaris) || 6260 || 247 || 0 || 0 || 0 || 0 || 0 || 0 || 981 || 7488

1.i.         Ferrets (Mustela putorius furo) || 28 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28

1.j.         Other Carnivores (other Carnivore) || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32

1.k.       Horses, donkeys and cross-breds (Equidae) || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 122

1.l.         Pigs (Sus) || 2589 || 5 || 0 || 0 || 0 || 0 || 196 || 152 || 595 || 3537

1.m.       Goats (Capra) || 0 || 8 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8

1.n.        Sheep (Ovis) || 569 || 0 || 0 || 0 || 0 || 0 || 21 || 140 || 16 || 746

1.o.        Cattle (Bos) || 732 || 19 || 0 || 0 || 0 || 0 || 6 || 0 || 51 || 808

1.p.        Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.q.        New World Monkeys (Ceboidea) || 38 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 44

1.r.        Old World Monkeys (Cercopithecoidea) || 2589 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 802 || 3391

1.s.        Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.t.        Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.u.        Quail (Coturnix coturnix) || 0 || 2859 || 0 || 0 || 0 || 0 || 0 || 0 || 235 || 3094

1.v.        Other birds (other Aves) || 8558 || 1775 || 0 || 0 || 0 || 0 || 3006 || 64 || 884 || 14287

1.w.       Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.x.        Amphibians (Amphibia) || 0 || 336 || 0 || 0 || 0 || 0 || 0 || 2340 || 19 || 2695

1.y.        Fish (Pisces) || 56463 || 20255 || 7163 || 0 || 0 || 276 || 0 || 83433 || 11493 || 179083

1.z.        TOTAL || 399794 || 81079 || 78316 || 977 || 90 || 2430 || 4604 || 92366 || 345217 || 1004873

(*) France reporting for 2010

III.5.      Results of EU Table 4: Animals used for studies of diseases

III.5.1.    The data on animals used for studies of diseases

The consolidated table of results of animals used for studies of diseases (EU Table 4) in the 27 Member States is presented in table 4.1 at the end of this chapter.

III.5.2.    Treatment and interpretation of the data

Table 4.1 gives the number of animals used per type of studies on diseases.

In 2011 the number of animals used for the study of both animal and human diseases represented 6 599 320 animals which is more than half (57%) the total number of animals used for scientific purposes in the EU.

Figure 4.1 presents the percentage of animals used in studies per type of disease, 90% of which are used for the study of human diseases.

In 2011, the overall number of animals used for studies on human and animal diseases has increased to a little more than 276 000 animals. The use of animals for specific studies on animal diseases in 2011 (which had a decrease of 50% in 2008) is comparatively unchanged from the 2008 report. There is a reduction in the use of cold-blooded animals by just under 22 500.

It is important to note that there has been a net increase of more than 115 000 animals used for studies on cardiovascular diseases, and of more than 250 000 for human cancer studies.

In comparison to 2008, increases of the use of animals have also been observed for dogs, totalling above 1 000; for other carnivores about 500; for other mammals a little above 300 and for other birds above 2 500.

On the other hand, the number of rats used for studies on diseases has decreased by more than 250 000 animals.

Table 4.1: Number of animals used in experiments for studies on human and animal diseases

Main category of diseases versus species Data of 2011 *

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

1.a.        Mice (Mus musculus) || 373188 || 872698 || 1049177 || 2106651 || 303009 || 4702052

1.b.        Rats (Rattus norvegicus) || 118848 || 409386 || 36156 || 438491 || 5337 || 1008156

1.c.        Guinea-Pigs (Cavia porcellus) || 2880 || 1893 || 44 || 27472 || 2373 || 34662

1.d.        Hamsters (Mesocricetus ) || 3000 || 398 || 779 || 5517 || 3269 || 12963

1.e.        Other Rodents (other Rodentia) || 1713 || 912 || 0 || 4723 || 2830 || 10178

1.f.        Rabbits (Oryctolagus cuniculus) || 5208 || 825 || 2852 || 24023 || 4523 || 37424

1.g.        Cats (Felis catus) || 2 || 64 || 4 || 217 || 2026 || 2313

1.h.        Dogs (Canis familiaris) || 860 || 79 || 187 || 3360 || 6543 || 11029

1.i.         Ferrets (Mustela putorius furo) || 0 || 156 || 0 || 2175 || 55 || 2386

1.j.         Other Carnivores (other Carnivore) || 19 || 0 || 0 || 538 || 1035 || 1592

1.k.       Horses, donkeys and cross-breds  (Equidae) || 1 || 0 || 0 || 135 || 2083 || 2219

1.l.         Pigs (Sus) || 6118 || 527 || 227 || 8743 || 16278 || 31893

1.m.       Goats (Capra) || 72 || 15 || 54 || 604 || 281 || 1026

1.n.        Sheep (Ovis) || 897 || 93 || 23 || 10683 || 3032 || 14728

1.o.        Cattle (Bos) || 220 || 0 || 0 || 2960 || 6507 || 9687

1.p.        Prosimians (Prosimia) || 0 || 58 || 0 || 25 || 0 || 83

1.q.        New World Monkeys (Ceboidea) || 15 || 171 || 0 || 385 || 0 || 571

1.r.        Old World Monkeys (Cercopithecoidea) || 369 || 88 || 61 || 1746 || 45 || 2309

1.s.        Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t.        Other Mammals (other Mammalia) || 0 || 154 || 18 || 833 || 700 || 1705

1.u.        Quail (Coturnix coturnix) || 0 || 640 || 0 || 244 || 4 || 888

1.v.        Other birds (other Aves) || 1037 || 2302 || 100 || 20365 || 204069 || 227873

1.w.       Reptiles (Reptilia) || 0 || 39 || 0 || 407 || 695 || 1141

1.x.        Amphibians (Amphibia) || 549 || 393 || 180 || 6066 || 949 || 8137

1.y.        Fish (Pisces) || 4814 || 45004 || 16059 || 367640 || 40788 || 474305

1.z.        TOTAL || 519810 || 1335895 || 1105921 || 3034003 || 606431 || 6599320

* France reporting for 2010

Table 4.2: Number of animals used in studies of diseases by classes of animals

Classes of animals || Human Cardiovascular diseases || Human nervous and mental disorder || Human cancer (excl. evaluation of carcino. hazards) || Other human diseases || Specific animal diseases || Total

Mice || 373188 || 872698 || 1049177 || 2106651 || 303009 || 4702052

Rats || 118848 || 409386 || 36156 || 438491 || 5337 || 1008156

Guinea-Pigs || 2880 || 1893 || 44 || 27472 || 2373 || 34662

Other Rodents || 4713 || 1310 || 779 || 10240 || 6099 || 23141

Rabbits || 5208 || 825 || 2852 || 24023 || 4523 || 37424

Carnivores || 881 || 299 || 191 || 6290 || 9659 || 17320

Artio + Perissodactyla || 7308 || 635 || 304 || 23125 || 28181 || 59553

Prosimians+Monkeys+Apes || 384 || 317 || 61 || 2156 || 45 || 2963

Other Mammals || 0 || 154 || 18 || 833 || 700 || 1705

Birds || 1037 || 2942 || 100 || 20609 || 204073 || 228761

Cold-blooded animals || 5363 || 45436 || 16239 || 374113 || 42432 || 483583

TOTAL || 519810 || 1335895 || 1105921 || 3034003 || 606431 || 6599320

|| || || || || ||

Classes of animals % || Human Cardiovascular diseases || Human nervous and mental disorder || Human cancer (excl. evaluation of carcino. hazards) || Other human diseases || Specific animal diseases || Total

Mice || 7,94 || 18,56 || 22,31 || 44,80 || 6,44 || 100,00

Rats || 11,79 || 40,61 || 3,59 || 43,49 || 0,53 || 100,00

Guinea-Pigs || 8,31 || 5,46 || 0,13 || 79,26 || 6,85 || 100,00

Other Rodents || 20,37 || 5,66 || 3,37 || 44,25 || 26,36 || 100,00

Rabbits || 13,92 || 2,20 || 7,62 || 64,19 || 12,09 || 100,00

Carnivores || 5,09 || 1,73 || 1,10 || 36,32 || 55,77 || 100,00

Artio + Perissodactyla || 12,27 || 1,07 || 0,51 || 38,83 || 47,32 || 100,00

Prosimians+Monkeys+Apes || 12,96 || 10,70 || 2,06 || 72,76 || 1,52 || 100,00

Other Mammals || 0,00 || 9,03 || 1,06 || 48,86 || 41,06 || 100,00

Birds || 0,45 || 1,29 || 0,04 || 9,01 || 89,21 || 100,00

Cold-blooded animals || 1,11 || 9,40 || 3,36 || 77,36 || 8,77 || 100,00

Species of table 4.1 were grouped into classes of animals and presented in table 4.2. The relative percentage of animals per class of species used in studies by type of disease has been calculated and is also presented in the lower part of table 4.2.

Figure 4.2 shows the proportion of animals used by classes per type of studies of diseases.

The top of each bar shows the relative percentage of animals used for studies on specific animal diseases. For this category a significant decrease in numbers of both Artiodactyla and Perissodactyla, has been recorded. However, an increase in the numbers of carnivores was observed for the same purpose.

In addition to the year 2011 having been relatively quiet from a zoo-sanitary point of view, and thus the pressure for testing in farm animals relatively low, other reasons indicated by Member States for a decrease in this area include 

- reduction of livestock housing capacity;

- move away from large animal-based to more basic laboratory-based bioscience type studies (on tissue culture, cell lines etc. rather than animal type studies);

- as larger animals models are particularly expensive to run, it was suggested that they may have become unsustainable for some laboratories; 

- larger animal models are normally used just before going into clinical trials and as such are cyclical.

Regarding the increased use of carnivores Member States indicated that these animals have been used in veterinary clinical trials, studies on genetic diseases, for research and development of products and devices for veterinary medicine and for vaccine studies (e.g. leishmania).

The data on the use of most species for all types of studies on both human and animal diseases show a similarity to the report of 2008. However, there is a substantial decrease in the use of 'other rodents' for studies of human diseases in particular 'human nervous and mental disorders'.

III.6.      Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine

III.6.1.    The data on animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine

The consolidated table for the 27 Member States reporting the origin of the regulatory requirements in relation to animals used for the production and quality control of products for human medicine and dentistry and for veterinary medicine (EU Table 5) is presented in table 5 at the end of this chapter.

III.6.2.    Treatment and interpretation of the data

The number of animals used in tests for the production and quality control of products for human medicine and dentistry and for veterinary medicine represents 13,9% of the total number of animals used for experimental purposes in 2011. Figure 5 gives the percentages of the animals used to satisfy the different regional regulatory requirements in this area.

The largest proportion of animals in this area (47%) was used to simultaneously satisfy requirements from several pieces of legislation emanating from the EU, the Council of Europe, from national legislation and from legislation outside of the EU. The testing carried out to satisfy EU legislation including the European Pharmacopoeia covered 35,9% of the animals used in this area.

In comparison to the report of 2008 it is important to note that there is an increase in the number of animals used for 'no regulatory requirements'.

It should also be noted that, there is a slight increase in the number of animals used to satisfy national legislation, despite the fact that there is a net reduction of the total number of animals used in this sector (192 000).

Table 5 Number of animals used in the production and quality control of products and devices for human medicine and dentistry and for veterinary medicine

Regulatory requirements versus species

Data of 2011 *

5.1 Species || 5.2 National legislation specific to a single EC Member State (1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation (2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total

1.a.        Mice (Mus musculus) || 48385 || 250338 || 2162 || 33046 || 486522 || 71461 || 891914

1.b.        Rats (Rattus norvegicus) || 3962 || 69859 || 0 || 4477 || 93887 || 3583 || 175768

1.c.        Guinea-Pigs (Cavia porcellus) || 1406 || 35856 || 0 || 4836 || 54984 || 5278 || 102492

1.d.        Hamsters (Mesocricetus ) || 0 || 1667 || 0 || 0 || 4334 || 0 || 6001

1.e.        Other Rodents (other Rodentia) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.f.        Rabbits (Oryctolagus cuniculus) || 1628 || 96730 || 13 || 880 || 71826 || 62757 || 234054

1.g.        Cats (Felis catus) || 0 || 265 || 0 || 0 || 38 || 1 || 304

1.h.        Dogs (Canis familiaris) || 118 || 597 || 0 || 0 || 262 || 15 || 992

1.i.         Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 32 || 58 || 90

1.j.         Other Carnivores (other Carnivore) || 19 || 213 || 0 || 0 || 0 || 309 || 541

1.k.        Horses, donkeys and cross-breds (Equidae) || 338 || 231 || 0 || 0 || 105 || 2083 || 2757

1.l.         Pigs (Sus) || 324 || 3694 || 15 || 0 || 2465 || 774 || 7382

1.m.       Goats (Capra) || 0 || 448 || 0 || 0 || 6 || 9 || 463

1.n.        Sheep (Ovis) || 109 || 1651 || 0 || 4 || 691 || 3901 || 6376

1.o.        Cattle (Bos) || 64 || 1806 || 0 || 4 || 741 || 546 || 3161

1.p.        Prosimians (Prosimia) || 0 || 21 || 0 || 0 || 0 || 0 || 21

1.q.        New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 79 || 0 || 79

1.r.        Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 138 || 0 || 138

1.s.        Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.t.        Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 56 || 4 || 60

1.u.        Quail (Coturnix coturnix) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.v.        Other birds (other Aves) || 3811 || 106761 || 0 || 385 || 36585 || 8037 || 155579

1.w.       Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.x.        Amphibians (Amphibia) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.y.        Fish (Pisces) || 1600 || 3296 || 0 || 0 || 0 || 4741 || 9637

1.z.        TOTAL || 61764 || 573433 || 2190 || 43632 || 752751 || 163557 || 1597809

(*) France reporting for 2010

Examples: || 5.2 - France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out ||

|| 5.3 - UK is testing according to EC legislation || || and not to the body which has issued the actual test method, guideline or protocol ||

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an ||

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be ||

|| 5.6 - Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. ||

|| || || ||

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of Macedonia' Turkey, Ukraine

III.7.      Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations

III.7.1.    The data on the origin of regulatory requirements for animals used in toxicological and other safety evaluations

The consolidated table for the 27 Member States reporting data on animals used in toxicological and other safety evaluations in relation to the origin of regulatory requirements (EU Table 6) is presented in table 6 at the end of this chapter.

III.7.2.    Treatment and interpretation of the data

The use of animals for the regulatory requirements of different regions in the area of toxicological or other safety evaluation presented in figure 6 follows a similar pattern to that of the use of animals used for regulatory purposes in human medicine, dentistry and in veterinary medicine in different regions, presented in the figure 5 in the previous chapter.

As pointed out earlier, the number of animals used in toxicological or other safety evaluation represents 8,75% of the total number of animals used for experimental purposes in the EU.

Animals used to simultaneously satisfy regulatory requirements from several pieces of legislation represent 56% of the animals used in this area. The testing required under EU legislation including the European Pharmacopoeia accounts for the second highest percentage in this area, namely 21,27%.

The percentage of the use of animals to satisfy requirements of different legislation has increased from fewer than 50% to more than 56%. 

There is also a decrease in the number of animals used for 'no regulatory requirements'.

In addition to the examples of the type of testing reported under 'no regulatory requirements' in the last report (namely those of in-house methods to verify the safety and efficacy of veterinary biologicals and medicinal products carried according to company’s or known international standards), Member States reported preliminary studies for trial of doses, optimisation of numbers and candidates, and probing mechanism of action of toxicities associated with clinically approved drugs or combination studies involving clinically approved drugs.

                                                            Table 6:          Number of animals used in toxicological and other safety evaluations

Regulatory requirements versus species

Data of 2011*

6.1 Species || 6.2 National legislation specific to a single EC Member State1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation2) || 6.5 Other legislation || 6.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 6.7 No regulatory requirements || 6.8 Total

1.a.          Mice (Mus musculus) || 33212 || 105801 || 361 || 5263 || 299377 || 20836 || 464850

1.b.          Rats (Rattus norvegicus) || 17657 || 44614 || 924 || 10481 || 183446 || 15459 || 272581

1.c.          Guinea-Pigs (Cavia porcellus) || 817 || 14340 || 37 || 1466 || 8503 || 1559 || 26722

1.d.          Hamsters (Mesocricetus ) || 149 || 278 || 0 || 174 || 946 || 0 || 1547

1.e.          Other Rodents (other Rodentia) || 4 || 70 || 0 || 0 || 191 || 35 || 300

1.f.           Rabbits (Oryctolagus cuniculus) || 1211 || 8685 || 257 || 1481 || 10796 || 525 || 22955

1.g.          Cats (Felis catus) || 68 || 283 || 0 || 0 || 76 || 16 || 443

1.h.          Dogs (Canis familiaris) || 737 || 1011 || 0 || 603 || 5024 || 107 || 7482

1.i.           Ferrets (Mustela putorius furo) || 0 || 118 || 0 || 0 || 20 || 0 || 138

1.j.           Other Carnivores (other Carnivore) || 0 || 8 || 0 || 0 || 0 || 0 || 8

1.k.          Horses, donkeys and cross-breds                  (Equidae) || 60 || 65 || 0 || 0 || 18 || 0 || 143

1.l.           Pigs (Sus) || 36 || 1292 || 0 || 307 || 1691 || 95 || 3421

1.m.         Goats (Capra) || 0 || 127 || 0 || 0 || 8 || 0 || 135

1.n.          Sheep (Ovis) || 320 || 58 || 0 || 69 || 159 || 140 || 746

1.o.          Cattle (Bos) || 238 || 89 || 0 || 0 || 436 || 24 || 787

1.p.          Prosimians (Prosimia) || 0 || 21 || 0 || 0 || 0 || 0 || 21

1.q.          New World Monkeys (Ceboidea) || 0 || 11 || 0 || 0 || 20 || 13 || 44

1.r.           Old World Monkeys (Cercopithecoidea) || 221 || 234 || 0 || 348 || 2558 || 30 || 3391

1.s.          Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.t.           Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.u.          Quail (Coturnix coturnix) || 45 || 380 || 0 || 0 || 2669 || 0 || 3094

1.v.          Other birds (other Aves) || 591 || 9654 || 0 || 0 || 3696 || 346 || 14287

1.w.          Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.x.          Amphibians (Amphibia) || 0 || 0 || 0 || 0 || 1539 || 1156 || 2695

1.y.          Fish (Pisces) || 34625 || 26566 || 0 || 3762 || 43305 || 70825 || 179083

1.z.          TOTAL || 89991 || 213705 || 1579 || 23954 || 564478 || 111166 || 1004873

(*) France is reporting for 2010

Examples: || 6.2 - France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and not to the body which has issued the actual test method, guideline or protocol

|| 6.3 - UK is testing according to EC legislation ||

|| 6.4 - Spain is testing due to a Norwegian  requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be ||

|| 6.6 - Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. ||

|| || || ||

|| Footnotes:1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, ||

|| Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom ||

|| 2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, ||

|| Switzerland, 'the former Yugoslav Rep. of Macedonia', Turkey, Ukraine || || ||

III.8.      Results of EU Table 7: Animals used in toxicity tests for toxicological and other safety evaluations

III.8.1.    The data on animals used in toxicity test for toxicological and other safety evaluations

The consolidated table for the 27 Member States reporting on animals used in toxicity tests for the purpose of toxicological and other safety evaluations of products (EU Table 7) is presented in table 7.1 at the end of this chapter.

III.8.2.    Treatment and interpretation of the data

For the convenience of the presentation of results some of the toxicity tests of table 7.1 have been grouped according to systemic and local toxicity and CMR effects in table 7.2. A graph showing the percentage of animals used per toxicity test groups in 2011 is presented in figure 7.

As pointed out in the previous chapter, the number of animals used in toxicological and other safety evaluations represents 8,75% of the total number of animals used for experimental purposes.

In figure 7 the largest percentage (47,5%) of use of animals is due to acute and sub-acute toxicity tests. Taking into account sub-chronic and chronic toxicity, the percentage of animals used in short- and long-term systemic toxicity testing accounts for 55% of the total number of animals used in this area.

Nearly 15% animals were used for testing carcinogenicity, mutagenicity and toxicity to reproduction. Another important category of use of animals in 2011 is for 'other tests' with 22%.

In addition to the type of testing reported under 'other toxicological and safety evaluation' in the previous report (namely those of neurotoxicity, toxicokinetics, testing of biological evaluation of medical devices: intracutaneous testing of reactivity in rabbits, studies into the penetration of nanoparticles through tissue and their biocompatibility, studies into the evaluation of sensitization potential of dyestuffs used in the textile industry and pharmacological studies included in safety tests), Member States reported that this heading covered also target animal studies carried out on companion animals to different regulatory standards e.g. US EPA, FDA, tests to determine the residues of veterinary medicaments in calves and in broilers, test to determine the non-toxicity and irreversibility of toxins and efficacy of vaccines (blue tongue, clostridium).

By looking both at numbers and relative percentages of use of animals in comparison to the previous reports there are two noticeable changes:

There is a continuous increase over the last four reports of the proportion of animals used for acute and sub-acute tests, from 36%, 42%, 45% to 47,5% respectively. This represents in animal numbers an increase of more than 8 400 animals since the last report.   

Contrary to the previous three reports where a steady decrease was observed, for 2011 the number of the animals used for reproductive toxicity testing has increased from 9% in 2008 to 11,35%. In terms of animal numbers it means an increase of almost 19 000 animals.

Table 7.1 Number of animals used in toxicological and other safety evaluations

Type of tests versus species Data of 2011*

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| 7.2.1. LD50, LC50 || 7.2.2. Other lethal methods || 7.2.3. Non lethal clinical signs methods || || || || || || || || || || ||

1.a.        Mice (Mus musculus) || 220544 || 51356 || 43637 || 64 || 16846 || 30 || 16436 || 5271 || 1188 || 9931 || 742 || 0 || 98796 || 464841

1.b.        Rats (Rattus norvegicus) || 8376 || 10870 || 65185 || 1490 || 64 || 0 || 42274 || 6445 || 20189 || 11278 || 61209 || 0 || 45200 || 272508

1.c.        Guinea-Pigs (Cavia porcellus) || 773 || 1847 || 1546 || 88 || 15214 || 0 || 1630 || 110 || 0 || 0 || 254 || 0 || 5270 || 26732

1.d.        Hamsters (Mesocricetus ) || 0 || 0 || 210 || 11 || 0 || 0 || 489 || 0 || 0 || 50 || 0 || 0 || 857 || 1617

1.e.        Other Rodents (other Rodentia) || 182 || 4 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 274 || 460

1.f.        Rabbits (Oryctolagus cuniculus) || 15 || 143 || 2947 || 3151 || 44 || 2080 || 634 || 0 || 2560 || 0 || 2978 || 0 || 8515 || 23067

1.g.        Cats (Felis catus) || 0 || 0 || 34 || 0 || 0 || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 285 || 331

1.h.        Dogs (Canis familiaris) || 0 || 123 || 2469 || 0 || 0 || 0 || 2785 || 0 || 0 || 0 || 95 || 0 || 1903 || 7375

1.i.         Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 52 || 52

1.j.         Other Carnivores (other                  Carnivore) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11 || 11

1.k.        Horses, donkeys and cross-                  breds (Equidae) || 0 || 0 || 33 || 0 || 0 || 0 || 0 || 0 || 60 || 0 || 0 || 0 || 148 || 241

1.l.         Pigs (Sus) || 0 || 39 || 807 || 45 || 0 || 0 || 729 || 0 || 22 || 0 || 86 || 0 || 1682 || 3410

1.m.       Goats (Capra) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8 || 8

1.n.        Sheep (Ovis) || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 0 || 299 || 0 || 0 || 0 || 438 || 767

1.o.        Cattle (Bos) || 0 || 0 || 45 || 0 || 0 || 0 || 24 || 0 || 230 || 0 || 0 || 0 || 488 || 787

1.p.        Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.q.        New World Monkeys (Ceboidea) || 0 || 0 || 24 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20 || 44

1.r.        Old World Monkeys                  (Cercopithecoidea) || 0 || 0 || 877 || 0 || 0 || 0 || 1306 || 0 || 266 || 0 || 15 || 0 || 927 || 3391

1.s.        Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.t.        Other Mammals (other                  Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.u.        Quail (Coturnix coturnix) || 329 || 370 || 0 || 0 || 0 || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 2350 || 3094

1.v.        Other birds (other Aves) || 423 || 182 || 4584 || 0 || 0 || 0 || 0 || 50 || 0 || 0 || 556 || 0 || 8492 || 14287

1.w.       Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.x.        Amphibians (Amphibia) || 0 || 0 || 1660 || 0 || 0 || 0 || 0 || 0 || 500 || 0 || 0 || 516 || 19 || 2695

1.y.        Fish (Pisces) || 34137 || 11641 || 11898 || 0 || 0 || 0 || 13730 || 0 || 16468 || 29 || 6381 || 38890 || 45909 || 179083

1.z.        TOTAL || 264779 || 76575 || 135956 || 4849 || 32168 || 2110 || 80124 || 11876 || 41782 || 21288 || 72316 || 39406 || 221644 || 1004873

(*) France reporting for 2010

Table 7.2 Grouping of certain type of tests on animals of table 7.1         

7.1 Species || Acute and sub-acute toxicity testing methods (including limit test) || Irritation /sensitization tests || Sub- chronic and chronic toxicity || Mutagenicity and carcinogenicity || Reproductive and developmental toxicity || Toxicity to aquatic vertebrates not included in other columns || Other || Total

1.a.        Mice (Mus musculus) || 315537 || 16940 || 16436 || 15202 || 1930 || 0 || 98796 || 464841

1.b.        Rats (Rattus norvegicus) || 84431 || 1554 || 42274 || 17723 || 81398 || 0 || 45200 || 272508

1.c.        Guinea-Pigs (Cavia porcellus) || 4166 || 15302 || 1630 || 110 || 254 || 0 || 5270 || 26732

1.d.        Hamsters (Mesocricetus ) || 210 || 11 || 489 || 50 || 0 || 0 || 857 || 1617

1.e.        Other Rodents (other Rodentia) || 186 || 0 || 0 || 0 || 0 || 0 || 274 || 460

1.f.        Rabbits (Oryctolagus cuniculus) || 3105 || 5275 || 634 || 0 || 5538 || 0 || 8515 || 23067

1.g.        Cats (Felis catus) || 34 || 0 || 12 || 0 || 0 || 0 || 285 || 331

1.h.        Dogs (Canis familiaris) || 2592 || 0 || 2785 || 0 || 95 || 0 || 1903 || 7375

1.i.         Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0 || 52 || 52

1.j.         Other Carnivores (other Carnivore) || 0 || 0 || 0 || 0 || 0 || 0 || 11 || 11

1.k.        Horses, donkeys and cross-breds                  (Equidae) || 33 || 0 || 0 || 0 || 60 || 0 || 148 || 241

1.l.         Pigs (Sus) || 846 || 45 || 729 || 0 || 108 || 0 || 1682 || 3410

1.m.       Goats (Capra) || 0 || 0 || 0 || 0 || 0 || 0 || 8 || 8

1.n.        Sheep (Ovis) || 0 || 0 || 30 || 0 || 299 || 0 || 438 || 767

1.o.        Cattle (Bos) || 45 || 0 || 24 || 0 || 230 || 0 || 488 || 787

1.p.        Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.q.        New World Monkeys (Ceboidea) || 24 || 0 || 0 || 0 || 0 || 0 || 20 || 44

1.r.        Old World Monkeys (Cercopithecoidea) || 877 || 0 || 1306 || 0 || 281 || 0 || 927 || 3391

1.s.        Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.t.        Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.u.        Quail (Coturnix coturnix) || 699 || 0 || 45 || 0 || 0 || 0 || 2350 || 3094

1.v.        Other birds (other Aves) || 5189 || 0 || 0 || 50 || 556 || 0 || 8492 || 14287

1.w.       Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

1.x.        Amphibians (Amphibia) || 1660 || 0 || 0 || 0 || 500 || 516 || 19 || 2695

1.y.        Fish (Pisces) || 57676 || 0 || 13730 || 29 || 22849 || 38890 || 45909 || 179083

1.z.        TOTAL || 477310 || 39127 || 80124 || 33164 || 114098 || 39406 || 221644 || 1004873

III.9.      Results of EU Table 8: Type of toxicity tests carried out for toxicological and other safety evaluations of products

III.9.1.    The data on type of toxicity tests carried out for toxicological and other safety evaluations of products

The consolidated table for the type of toxicity tests carried out for toxicological or other safety evaluations of products for the 27 Member States reporting (EU Table 8) is presented in table 8.1 of this report.

III.9.2.    Treatment and interpretation of the data

As pointed out earlier, animals used in toxicological and other safety evaluation represent 8,75% of the total number of animals used for experimental purposes.

In order to facilitate the interpretation of the results some types of toxicity testing have been grouped and the results can be found in consolidated table 8.2 at the end of this chapter. The treatment and interpretation of the data on animals used for toxicity tests with regard to the type of products was done for the first time in the Fifth Statistical Report.

Figure 8 gives the proportion of animals used for toxicity and other safety evaluation by types of products. 

Figure 8 shows that the majority of animals tested in acute/sub-acute toxicity are intended for the purpose of 'human medicine, dentistry and veterinary medicine' and for 'other toxicological and safety evaluation'. For irritation/sensitization properties and for carcinogenicity/mutagenicity and reprotox the three categories of uses; human medicine, agriculture and industrial products show a similar pattern of use of animals. Whereas the largest number of animals used in sub-chronic and chronic toxicity test are carried out mainly for human medicine, dentistry and veterinary medicine.

In Figure 8 it is difficult to show the numbers of animals used for testing, for example, household products and additives for human consumption because they are much lower than in the other categories e.g. for household products only 800 animals were used whereas for products for human medicine, dentistry and veterinary medicine almost 400 000 animals were used.

Overall products intended for medicine, dentistry and veterinary medicine required the highest proportion of animals for the different types of tests i.e. approximately 39%. In comparison to 2008 the amount of animals used in 2011 has been reduced by more than 130 000.

The next highest proportion is for 'other' toxicological evaluations, above 34%, (22% in 2008) this means an increase of use of 122 000 animals. The third type of test using the largest number of animals is that used for potential and actual contaminants in the general environment with 92 000 animals or 9%.

Table 8.1:      Number of animals used in toxicological and other safety evaluations

Type of tests versus products

Data of 2011*

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino- genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10  Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| 8.2.1. LD50, LC50 || 8.2.2. Other lethal methods || 8.2.3. Non lethal clinical signs methods || || || || || || || || || || ||

8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 40400 || 13904 || 86828 || 1772 || 14410 || 336 || 49351 || 6087 || 15247 || 10796 || 35906 || 1671 || 122646 || 399354

8.b. Products/ substances used or intended to be used mainly in agriculture || 6079 || 7825 || 7479 || 992 || 3047 || 801 || 8200 || 4884 || 8335 || 2255 || 12359 || 7089 || 11634 || 80979

8.c. Products/ substances used or intended to be used mainly in industry || 3635 || 1690 || 13974 || 1461 || 10200 || 613 || 2691 || 4 || 11493 || 6805 || 14682 || 2208 || 9564 || 79020

8.d. Products/ substances used or intended to be used mainly in the household || 40 || 119 || 79 || 47 || 76 || 2 || 80 || 0 || 0 || 0 || 46 || 0 || 348 || 837

8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries || 25 || 25 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 90

8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption || 25 || 131 || 57 || 0 || 24 || 0 || 1300 || 0 || 0 || 152 || 0 || 0 || 741 || 2430

8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption || 53 || 928 || 0 || 0 || 0 || 0 || 100 || 0 || 0 || 54 || 0 || 0 || 3469 || 4604

8.h. Potential or actual contaminants in the general environment which do not appear in other columns || 27673 || 9521 || 6620 || 2 || 0 || 0 || 10759 || 664 || 5264 || 28 || 4439 || 25529 || 1867 || 92366

8.i. Other toxicological or safety evaluations || 186849 || 42432 || 20879 || 575 || 4411 || 358 || 7643 || 237 || 1443 || 1198 || 4884 || 2909 || 71375 || 345193

8.j. TOTAL || 264779 || 76575 || 135956 || 4849 || 32168 || 2110 || 80124 || 11876 || 41782 || 21288 || 72316 || 39406 || 221644 || 1004873

(*) France reporting for 2010

  Table 8.2: Number of animals used in toxicological and other safety evaluation per types of products

8.1. Products || Acute and sub-acute toxicity testing methods (including limit test) || Irritation/sensitization tests || Sub- chronic and chronic toxicity || Carcinogenicity, Mutagenicity and Reprotox || Toxicity to aquatic vertebrates not included in other columns || Other || Total

8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 141132 || 16518 || 49351 || 68036 || 1671 || 122646 || 399354

8.b. Products/ substances used or intended to be used mainly in agriculture || 21383 || 4840 || 8200 || 27833 || 7089 || 11634 || 80979

8.c. Products/ substances used or intended to be used mainly in industry || 19299 || 12274 || 2691 || 32984 || 2208 || 9564 || 79020

8.d. Products/ substances used or intended to be used mainly in the household || 238 || 125 || 80 || 46 || 0 || 348 || 837

8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries || 90 || 0 || 0 || 0 || 0 || 0 || 90

8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption || 213 || 24 || 1300 || 152 || 0 || 741 || 2430

8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption || 981 || 0 || 100 || 54 || 0 || 3469 || 4604

8.h. Potential or actual contaminants in the general environment which do not appear in other columns || 43814 || 2 || 10759 || 10395 || 25529 || 1867 || 92366

8.i. Other toxicological or safety evaluations || 250160 || 5344 || 7643 || 7762 || 2909 || 71375 || 345193

8.j. TOTAL || 477310 || 39127 || 80124 || 147262 || 39406 || 221644 || 1004873

           

[1]               OJL 358, 18.12.1986, p.1.

[2]               COM (94) 195 final

[3]               COM (1999) 191 final

[4]               COM (2007) 675 final

[5]               COM (2010) 1107 final/2

[6]               OJ C 331, 23.12.86, p. 2.

COMMISSION STAFF WORKING DOCUMENT

Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

PART B I: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATE

TABLE OF CONTENTS

BELGIUM.................................................................................................................................. 5

BULGARIA............................................................................................................................. 19

CZECH REPUBLIC................................................................................................................ 32

DENMARK.............................................................................................................................. 41

GERMANY.............................................................................................................................. 50

BELGIUM

Statistical data submitted

The statistical data were submitted by the "SPF Santé Publique, Sécurité de la Chaine Alimentaire et Environnement" (Federal Public Service Health, Food Chain Safety and Environment).

Comments of the Belgian authorities

1.           Laboratories

In 2011, 367 laboratories were approved for the use of animals for experimental purposes. They all provided their statistical data on the number of animals used in the course of 2011. Of these laboratories, 21% did not carry out any animal experiments in 2011.

2.           Number of animals used in experiments

A total of 665,079 animals were used (Table 1), which is 5% less than the figure for 2010.

                  Table 1: 2011 - Number of animals used in experiments

Species || Number

Mice || 408 883

Rats || 89 547

Guinea pigs || 24 300

Hamsters || 2 435

Other rodents || 421

Rabbits || 54 001

Cats || 630

Dogs || 490

Ferrets || 192

Other carnivores || 0

Horses, donkeys and cross-breeds || 54

Pigs || 2 622

Goats || 86

Sheep || 542

Cattle || 810

Prosimians || 0

New world monkeys || 0

Old world monkeys || 20

Apes || 0

Other mammals || 64

Quails || 651

Other birds || 16 493

Reptiles || 459

Amphibians || 2 113

Fish || 60 266

TOTAL || 665 079

As regards the breakdown of the different animal species (Table 2), rodents and rabbits together made up 87.15% of the total number of animals used. Next come, in descending order, reptiles, amphibians and fish (9%) and birds (2.58%). Other species (farm animals, dogs and cats, monkeys) were much less used.

                  Table 2: 2011 - Breakdown of species used in experiments

Species || Percentage || Number

Rodents || 79.03% || 525 586

Rabbits || 8.12% || 54 001

Dogs/Cats || 0.17% || 1 120

Farm animals || 0.62% || 4 114

Primates || 0.0030% || 20

Birds || 2.58% || 17 144

Other warm-blooded animals || 0.04% || 256

Cold-blooded animals || 9.45% || 62 838

3.           Experiments carried out

Animals are most used in the following fields (Figures 1 and 2):

· Basic research (38%), where the most commonly used animals were rodents (73%) and fish (20%).

· Research and development of products and devices used in human and veterinary medicine (27%), where 96% of the animals used were rodents.

· Tests on the production and quality control of products and devices used in human and veterinary medicine (28%); 72% of the animals used were rodents and 26% rabbits. As regards these tests, 98% of the animals were used to comply with statutory requirements.

Key to table:

Toxicologie - Toxicology

Diagnostic - Diagnosis

Formation - Training

Autres - Other

Biol. Fond - Basic biology

R&D - Research and Development

QC - Quality Control

                 

Figure 1: 2011 - Breakdown of the experimental fields

In 2011, toxicological safety tests accounted for only 1.7% of the animals used in experiments; 85% of these animals were used in safety tests required by law. Rodents accounted for 76% of all the animals used in toxicological tests. The other species used were mainly fish (5%), birds (9%), dogs (3%) and rabbits (2%).

Key to table:

Rongeurs - Rodents

Oiseaux - Birds

Animaux à sang froid - Cold-blooded animals

Lapins - Rabbits

Autres - Other

Formation - Training

Diagnostic - Diagnosis

Toxicologie - Toxicology

QC - Quality Control

R&D - Research and Development

Biologie fondamentale - Basic biology          

Figure 2: 2011 - Breakdown of experimental fields by the animals most used

The increase in the number of cats used as test animals (from 349 in 2010 to 630 in 2011) is mainly due to the research project on the sterilisation / early castration of cats. The project is part of the multiannual plan of the Animal Welfare Service of the Federal Public Service (SPF) for Public Health.

4.           The provenance of the animals used in experiments

In 2011, 87% of the animals provided by approved establishments came from Council of Europe Member States. The other species of animal that must not be reared solely for the purposes of animal experiments (farm animals) came from establishments that meet the current legal requirements for commercial establishments. The number of animals reused in certain experiments was 0.01% of the total number of animals used in 2011.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 408883 || 135811 || 250514 || 40 || 22518 ||

1.b. || Rats (Rattus norvegicus) || 89547 || 17337 || 71081 || 0 || 1129 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 24300 || 1942 || 22358 || 0 || 0 ||

1.d. || Hamsters (Mesocricetus ) || 2435 || 412 || 1683 || 0 || 340 ||

1.e. || Other Rodents (other Rodentia) || 421 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 54001 || 53146 || 851 || 0 || 4 || 379

1.g. || Cats (Felis catus) || 630 || 24 || 20 || 0 || 586 || 53

1.h. || Dogs (Canis familiaris) || 490 || 13 || 427 || 0 || 50 || 408

1.i. || Ferrets (Mustela putorius furo) || 192 || 0 || 192 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 0 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 54 || || || || ||

1.l. || Pigs (Sus) || 2622 || || || || ||

1.m. || Goats (Capra) || 86 || || || || ||

1.n. || Sheep (Ovis) || 542 || || || || ||

1.o. || Cattle (Bos) || 810 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 20 || 10 || 6 || 3 || 1 || 54

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 64 || || || || ||

1.u. || Quail (Coturnix coturnix) || 651 || 11 || 0 || 0 || 640 ||

1.v. || Other birds (other Aves) || 16493 || || || || ||

1.w. || Reptiles (Reptilia) || 459 || || || || ||

1.x. || Amphibians (Amphibia) || 2113 || || || || ||

1.y. || Fish (Pisces) || 60266 || || || || ||

1.z. || TOTAL || 665079 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 169926 || 118167 || 100056 || 3341 || 1939 || 7424 || 5308 || 2722 || 408883

2.b. || Rats || 18109 || 52400 || 9850 || 594 || 6524 || 387 || 1585 || 98 || 89547

2.c. || Guinea-Pigs || 252 || 2200 || 19469 || 1600 || 190 || 0 || 586 || 3 || 24300

2.d. || Hamsters || 350 || 532 || 0 || 1426 || 0 || 0 || 127 || 0 || 2435

2.e. || Other Rodents || 368 || 0 || 0 || 0 || 0 || 0 || 15 || 38 || 421

2.f. || Rabbits || 1280 || 1941 || 49354 || 1036 || 257 || 0 || 123 || 10 || 54001

2.g. || Cats || 22 || 4 || 0 || 18 || 0 || 586 || 0 || 0 || 630

2.h. || Dogs || 37 || 8 || 0 || 34 || 349 || 50 || 12 || 0 || 490

2.i. || Ferrets || 0 || 177 || 0 || 0 || 0 || 0 || 15 || 0 || 192

2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.k. || Horses, donkeys and cross breds || 19 || 6 || 0 || 2 || 0 || 0 || 27 || 0 || 54

2.l. || Pigs || 1285 || 334 || 0 || 533 || 92 || 15 || 107 || 256 || 2622

2.m. || Goats || 20 || 66 || 0 || 0 || 0 || 0 || 0 || 0 || 86

2.n. || Sheep || 351 || 105 || 0 || 48 || 0 || 14 || 24 || 0 || 542

2.o. || Cattle || 379 || 104 || 0 || 237 || 63 || 0 || 17 || 10 || 810

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.r. || Old World Monkeys || 9 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 20

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 15 || 49 || 0 || 0 || 0 || 0 || 0 || 0 || 64

2.u. || Quail || 651 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 651

2.v. || Other birds || 10884 || 1801 || 0 || 1536 || 1080 || 102 || 2 || 1088 || 16493

2.w. || Reptiles || 375 || 84 || 0 || 0 || 0 || 0 || 0 || 0 || 459

2.x. || Amphibians || 730 || 900 || 0 || 0 || 336 || 0 || 147 || 0 || 2113

2.y. || Fish || 51605 || 1250 || 0 || 0 || 551 || 0 || 3860 || 3000 || 60266

2.z. || TOTAL || 256667 || 180139 || 178729 || 10405 || 11381 || 8578 || 11955 || 7225 || 665079

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 1322 || 20 || 60 || 0 || 0 || 321 || 0 || 0 || 216 || 1939

3.b. || Rats || 6251 || 9 || 209 || 0 || 0 || 0 || 0 || 0 || 55 || 6524

3.c. || Guinea-Pigs || 190 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 190

3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 251 || 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 257

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 349 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 349

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.l. || Pigs || 55 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 37 || 92

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.o. || Cattle || 14 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 49 || 63

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.v. || Other birds || 552 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 528 || 1080

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 336 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 336

3.y. || Fish || 0 || 137 || 414 || 0 || 0 || 0 || 0 || 0 || 0 || 551

3.z. || TOTAL || 8984 || 508 || 683 || 0 || 0 || 321 || 0 || 0 || 885 || 11381

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 14294 || 44652 || 46555 || 125337 || 4758 || 232925

4.b. || Rats || 4332 || 29474 || 1749 || 28049 || 384 || 63926

4.c. || Guinea-Pigs || 800 || 0 || 0 || 1284 || 82 || 2166

4.d. || Hamsters || 0 || 0 || 14 || 490 || 0 || 504

4.e. || Other Rodents || 0 || 0 || 0 || 603 || 108 || 711

4.f. || Rabbits || 160 || 0 || 21 || 1147 || 104 || 1425

4.g. || Cats || 0 || 0 || 0 || 31 || 590 || 621

4.h. || Dogs || 115 || 0 || 0 || 5 || 54 || 174

4.i. || Ferrets || 0 || 0 || 0 || 177 || 0 || 177

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 8 || 8

4.l. || Pigs || 239 || 0 || 0 || 157 || 324 || 720

4.m. || Goats || 20 || 0 || 0 || 0 || 0 || 20

4.n. || Sheep || 286 || 0 || 0 || 126 || 17 || 429

4.o. || Cattle || 0 || 0 || 0 || 0 || 266 || 266

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.r. || Old World Monkeys || 0 || 0 || 0 || 15 || 0 || 15

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 16 || 15 || 0 || 31

4.u. || Quail || 0 || 640 || 0 || 0 || 0 || 640

4.v. || Other birds || 0 || 45 || 0 || 292 || 8612 || 8949

4.w. || Reptiles || 0 || 0 || 0 || 0 || 84 || 84

4.x. || Amphibians || 0 || 0 || 0 || 404 || 38 || 442

4.y. || Fish || 0 || 80 || 0 || 2096 || 6053 || 8229

4.z. || TOTAL || 20246 || 74891 || 48355 || 160228 || 21482 || 322462

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 0 || 9859 || 0 || 12626 || 79132 || 1780 || 103397 ||

5.b. || Rats || 90 || 0 || 0 || 3060 || 5254 || 2040 || 10444 ||

5.c. || Guinea-Pigs || 0 || 1121 || 0 || 2848 || 17100 || 0 || 21069 ||

5.d. || Hamsters || 0 || 84 || 0 || 0 || 1342 || 0 || 1426 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 0 || 369 || 0 || 758 || 49263 || 0 || 50390 ||

5.g. || Cats || 0 || 18 || 0 || 0 || 0 || 0 || 18 ||

5.h. || Dogs || 0 || 30 || 0 || 0 || 4 || 0 || 34 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 2 || 0 || 0 || 0 || 0 || 2 ||

5.l. || Pigs || 0 || 533 || 0 || 0 || 0 || 0 || 533 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 48 || 0 || 0 || 0 || 0 || 48 ||

5.o. || Cattle || 0 || 237 || 0 || 0 || 0 || 0 || 237 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 0 || 1536 || 0 || 0 || 0 || 0 || 1536 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.z. || TOTAL || 90 || 13837 || 0 || 19292 || 152095 || 3820 || 189134 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 25 || 537 || 0 || 0 || 797 || 580 || 1939 ||

6.b. || Rats || 114 || 55 || 0 || 0 || 5965 || 390 || 6524 ||

6.c. || Guinea-Pigs || 0 || 0 || 0 || 0 || 0 || 190 || 190 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 0 || 0 || 0 || 0 || 255 || 2 || 257 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 0 || 0 || 0 || 0 || 349 || 0 || 349 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.l. || Pigs || 0 || 0 || 0 || 0 || 92 || 0 || 92 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.o. || Cattle || 0 || 0 || 0 || 0 || 39 || 24 || 63 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.v. || Other birds || 0 || 552 || 0 || 0 || 528 || 0 || 1080 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 336 || 336 ||

6.y. || Fish || 0 || 0 || 0 || 414 || 0 || 137 || 551 ||

6.z. || TOTAL || 139 || 1144 || 0 || 414 || 8025 || 1659 || 11381 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 180 || 128 || 415 || 0 || 80 || 0 || 427 || 0 || 0 || 0 || 208 || 0 || 501 || 1939

7.b. || Rats || 0 || 52 || 2213 || 0 || 0 || 0 || 815 || 490 || 0 || 454 || 2062 || 0 || 438 || 6524

7.c. || Guinea-Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 190 || 190

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 49 || 3 || 0 || 3 || 0 || 0 || 0 || 0 || 197 || 0 || 5 || 257

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 229 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 120 || 349

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.l. || Pigs || 0 || 0 || 55 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 37 || 92

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 24 || 0 || 0 || 0 || 0 || 0 || 39 || 63

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1080 || 1080

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 336 || 0 || 336

7.y. || Fish || 414 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 137 || 0 || 551

7.z. || TOTAL || 594 || 180 || 2961 || 3 || 80 || 3 || 1266 || 490 || 0 || 454 || 2467 || 473 || 2410 || 11381

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 180 || 180 || 2743 || 0 || 0 || 0 || 1042 || 490 || 0 || 454 || 2467 || 0 || 1428 || 8984

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 9 || 3 || 20 || 3 || 0 || 0 || 0 || 0 || 0 || 473 || 0 || 508

8.c. || Products/substances used or intended to be used mainly in industry || 414 || 0 || 209 || 0 || 60 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 683

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 321 || 321

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.i. || Other toxicological or safety evaluations || 0 || 0 || 0 || 0 || 0 || 0 || 224 || 0 || 0 || 0 || 0 || 0 || 661 || 885

8.j. || TOTAL || 594 || 180 || 2961 || 3 || 80 || 3 || 1266 || 490 || 0 || 454 || 2467 || 473 || 2410 || 11381

BULGARIA

Statistical data submitted

The statistical data were submitted by the Ministry of Agriculture and Food.

Comments of the Bulgarian authorities

The objective of this report is to present the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, the statistical data on the number of animals used for experimental and other scientific purposes in Republic of Bulgaria.

This report contains statistical data on the animals used for experimental and other scientific purposes. The data for this report covers the year 2011.

The Bulgarian Food Safety Agency (BFSA) is the competent authority on Animal welfare issues in Republic of Bulgaria. An organizational and implementation principle is that the AW requirements on the matters concerning animals used for experimental purposes must be performed by the 28 Regional Food Safety Directorates (RFSD) within the BFSA. The requirements of Directive 86/609/EEC have been transposed into the national legislation, namely in Ordinance № 15 on the minimum requirements for protection and welfare of laboratory animals and the requirements to the establishments using, breeding and/or supplying such animals (in force since 01.05.2006; published in SG No. 17 of 24 February 2006) and in the Law for Veterinary Activities.

In Bulgaria, experiments involving usage of live animals are carried out only where it is not possible to apply any alternative method(s) of the same purpose and result.

The use of experimental animals is permitted only in premises, that are authorized as being in compliance with the requirements laid down in Article 153 (1) of the Law on Veterinary Activities and which have official permit signed by the BFSA Executive Director. The BFSA Executive Director would issue the above mentioned permit on the basis of an ethical assessment and a positive opinion from the Animal Ethics Commission within BFSA. The Animal Ethics Commission has been established as a permanently operating consultative body with the BFSA Executive Director.

The members of the Animal Ethics Commission are as follows:

An official veterinary officer representing BFSA;

1. A veterinarian representing the Faculties of Veterinary Medicine;

2. A physician of toxicological specialization representing Ministry of Health;

3. A scientist or researcher of biological specialization representing Bulgarian Academy of Sciences;

4. An environmental expert representing Ministry of Environment and Water;

5. A zoologist representing the Biology Faculty at Sofia University;

6. A physician representing the Medical University in Sofia;

7. Two representatives of NGOs operating in the field of AW and protection of animals;

8. A lawyer representing the Ministry of Agriculture and Food;

9. A veterinarian representing the Ministry of Agriculture and Food.

The BFSA have a register of licenses for animals used for scientific purposes, published on the web-site:

http://babh.government.bg/uploads/File/ENG/Registers/ZHOJ/Register_engl_opitni_jivotni.pdf

The register is updated regularly.

In order to present an overall evaluation and subsequently a graphical analysis, animal species were grouped. The Figure 1 gives an overview of the species used in 2011 in Republic of Bulgaria.

Amphibians represent the highest percentage of the animals used in 2011 (24.83%) followed by the mice (22.13%) and guinea pigs (21.44%) are by far the most commonly used species.

Comparison between proportions of classes of animals used in 2008 and 2011

Class of species || 2008 (%) || 2011(%)

Mice || 49,90 || 22,13

Rats || 13,85 || 14,88

Guinea-Pigs || 11,80 || 21,44

Hamsters || 0,56 || 2,99

Rabbits- || 2,50 ||

Cats || 0,03 || 4,76

Dogs || 0,05 || 0,05

Horses || 0,05 ||

Pigs  || 0,42 ||

Goats || 0,25 ||

Sheep  || 0,77 ||

Cattle || 0,39 ||

Other birds || 4,54 || 0,64

Amphibians || 14,74 || 24.83

Fish - || 0,15 || 0.17

Comparison with the data of the previous report

The comparison aims to detect changes in trends rather than draw formal conclusions.

The most significant change that has taken place since 2008 is that the number of animals used for research and development for human medicine, dentistry and veterinary medicine has dropped sharply from 32,581 to 17,259.

The number of mice used in 2011 has drastically decreased with more than 25% - from 49.90 % in 2008 to 22.13% in 2011. In 2011 the use of cold-blooded animals has increased with about 10% - from 14, 75% in 2008 to 24,83%.

Birds seem to be decrease over the years from 4.54 to 0.64%. The group of horses, donkeys and cross-bred animals (artiodactyla) and pigs, goats, sheep and cattle (perissodactyla) fluctuates at around 1%.

In Bulgaria the animals used for scientific purposes in 2011 are originated from EU countries.

The following experiments were carried out in 2011:

· Education and training (E&T)

· Biological studies of a fundamental nature

· Research and development of products and devices for human medicine and dentistry and for veterinary medicine (R&D)

· Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary

· Medicine (T&S evaluations)

· Studies and Diagnosis of Human and Animal disease (S&D of disease)

Experiments which are not permitted in Bulgaria:

(1) for educational purposes, which cause death of animals; in educational establishments animal experiments shall be replaced by other methods for visualizing the subject taught in all cases where the use of animals might be replaced by other methods and if the aim is not to provide the students with specific practical skills;

(2) if the result can be achieved with any method not involving the use of live animal(s);

(3) if they use stray and/or domestic dogs or cats as experimental animals.

Table 2.2 presents the results of the consolidated data of the purposes of the procedures carried out in Republic of Bulgaria in 2011.

The number of animals used for selected purposes is presented in Figure 2:

The percentage of animals used for selected purposes is presented in Figure 3:

The main percentage of used animals is for education and training – 33.79%. The 25, 59% of animals were used in fundamental biological studies.

Toxicological and other safety evaluation represents 17.41% of the total number of animals used for experimental purposes.

Production and quality control of products and devices in human medicine, veterinary medicine and dentistry required the use of 4.64% of the total number of animals.

Conclusion:

In 2011 in Republic of Bulgaria there is a huge decrease with about 53% in the total number of animals used. The main percentage of used animals is for education and training.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 3819 || 2206 || 13 || 1600 || ||

1.b. || Rats (Rattus norvegicus) || 2569 || 2569 || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 3700 || 700 || || 3000 || ||

1.d. || Hamsters (Mesocricetus ) || 516 || 516 || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 822 || 579 || 3 || 240 || || 110

1.g. || Cats (Felis catus) || 8 || 8 || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || 110 || || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || 320 || || || || ||

1.o. || Cattle (Bos) || || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 1080 || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || 4285 || || || || ||

1.y. || Fish (Pisces) || 30 || || || || ||

1.z. || TOTAL || 17259 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 1034 || 265 || 200 || 400 || 1195 || 40 || 685 || || 3819

2.b. || Rats || 1082 || 682 || || || 10 || || 627 || 168 || 2569

2.c. || Guinea-Pigs || 390 || || 532 || 1200 || 1510 || || 68 || || 3700

2.d. || Hamsters || 512 || || || || || || 4 || || 516

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || 9 || || 60 || 310 || 240 || || 193 || 10 || 822

2.g. || Cats || || || 8 || || || || || || 8

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || || || || 110 || || || || || 110

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || 300 || || || 20 || || || || || 320

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || 1030 || || || || 50 || || || || 1080

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || 60 || || || || || || 4225 || || 4285

2.y. || Fish || || || || || || || 30 || || 30

2.z. || TOTAL || 4417 || 947 || 800 || 2040 || 3005 || 40 || 5832 || 178 || 17259

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 945 || || || || || || || || 250 || 1195

3.b. || Rats || || || || || || || || || 10 || 10

3.c. || Guinea-Pigs || 1100 || || || || || || || || 410 || 1510

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 120 || || || || || || || || 120 || 240

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || || || || || || || || || || 0

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || 50 || 50

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 2165 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 840 || 3005

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 40 || 211 || || 204 || 170 || 625

4.b. || Rats || || 5 || || 233 || 84 || 322

4.c. || Guinea-Pigs || || || || || || 0

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || || || || 16 || || 16

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || || || || || 0

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || || 0

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || 80 || 80

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 40 || 216 || 0 || 453 || 334 || 1043

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || 600 || || || || || 600 ||

5.b. || Rats || || || || || || || 0 ||

5.c. || Guinea-Pigs || || 1600 || || || || || 1732 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || 150 || || || || || 370 ||

5.g. || Cats || || 8 || || || || || 8 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 110 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 20 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 0 || 2358 || 0 || 0 || 0 || 0 || 2840 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || 1195 || || || || || 1195 ||

6.b. || Rats || || 10 || || || || || 10 ||

6.c. || Guinea-Pigs || || 1510 || || || || || 1510 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || 240 || || || || || 240 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || || || 0 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || || || 0 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || 50 || || || || || 50 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || || 0 ||

6.y. || Fish || || || || || || || 0 ||

6.z. || TOTAL || 0 || 3005 || 0 || 0 || 0 || 0 || 3005 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || 945 || || || || || || 50 || || || || || 200 || 1195

7.b. || Rats || || || || || || || || 10 || || || || || || 10

7.c. || Guinea-Pigs || || 1100 || || || || || || 110 || || || || || 300 || 1510

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || 120 || || || || || || || || || || || 120 || 240

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || || || || || || || || || || || || 0

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || || 0

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || 50 || || || || || || 50

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || || || || || || || || 0

7.z. || TOTAL || 0 || 2165 || 0 || 0 || 0 || 0 || 0 || 220 || 0 || 0 || 0 || 0 || 620 || 3005

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 1325 || || || || || || 220 || || || || || 620 || 2165

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || || 840 || || || || || || || || || || || || 840

8.j. || TOTAL || 0 || 2165 || 0 || 0 || 0 || 0 || 0 || 220 || 0 || 0 || 0 || 0 || 620 || 3005

CZECH REPUBLIC

Statistical data submitted

The statistical data were submitted by the Ministry of Agriculture (Ministerstvo zemědělství).

Comments of the Czech authorities

Protection of animals and animal welfare in the Czech Republic (CR) is the responsibility of the Ministry of Agriculture. The animal welfare activities are implemented pursuant to Act No. 246/1992 Coll., on the protection of animals against cruelty, as amended. The supervision over these matters has been the responsibility of the State Veterinary Administrations’ inspectors in 13 regions of the CR and in Prague since 1992.

Altogether 131 inspections of experiments on animals were carried out in 2011, involving 118,558 animals. The administrative procedure was carried out with the user establishment taking blood samples of horses for pharmacological purposes.

In 2011 a total of 354,196 animals were used for experimental and other scientific purposes in the CR. It shall be pointed out that 45.95% of it is represented by ringed birds (162,768 birds) since pursuant to the relevant Czech legislation even bird ringing is an experiment.

Only 0.09 % were cats (181 cats), 0.72 % dogs (1,386 dogs), 0.02% monkeys (30 monkeys) of the remaining 191,428 animals used for experimental and scientific purposes while no apes were used. Rodents and rabbits (60.60%, i.e. 116,010 animals) and fish (27.61%, i.e. 52,861 fish) represent the prevailing majority of animals used.

In the last couple of years the number of experimental animals used in the CR was approximately the same (approximately 210,000 animals excluding ringed birds). Fluctuations in numbers, if any, are caused by experiments using fish and poultry because these experiments are usually conducted on a large group of animals (a flock in houses or stock in water reservoirs).

The use of alternative methods to experiments on animals has been pushed through in the CR. Persons who manage, control and conduct experiments on animals are obliged to seek in the registers of validated alternative methods such methods which are applicable to their experiment. In the experimental project the applicant shall declare in writing that no validated alternative method can be applied for the given purpose.

The training courses for persons who manage, control and conduct experiments on animals comprise also teaching of alternative methods to experiments on animals.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 72855 || 72599 || 256 || 0 || 0 ||

1.b. || Rats (Rattus norvegicus) || 30829 || 30641 || 188 || 0 || 0 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 3304 || 3304 || 0 || 0 || 0 ||

1.d. || Hamsters (Mesocricetus ) || 119 || 49 || 70 || 0 || 0 ||

1.e. || Other Rodents (other Rodentia) || 1316 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 7677 || 4540 || 3137 || 0 || 0 || 20

1.g. || Cats (Felis catus) || 181 || 181 || 0 || 0 || 0 || 260

1.h. || Dogs (Canis familiaris) || 1386 || 1346 || 40 || 0 || 0 || 52

1.i. || Ferrets (Mustela putorius furo) || 193 || 185 || 8 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 45 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 595 || || || || ||

1.l. || Pigs (Sus) || 2283 || || || || ||

1.m. || Goats (Capra) || 106 || || || || ||

1.n. || Sheep (Ovis) || 1147 || || || || ||

1.o. || Cattle (Bos) || 783 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 30 || 30 || 0 || 0 || 0 || 0

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 2838 || || || || ||

1.u. || Quail (Coturnix coturnix) || 230 || 230 || 0 || 0 || 0 ||

1.v. || Other birds (other Aves) || 170261 || || || || ||

1.w. || Reptiles (Reptilia) || 1258 || || || || ||

1.x. || Amphibians (Amphibia) || 3989 || || || || ||

1.y. || Fish (Pisces) || 52771 || || || || ||

1.z. || TOTAL || 354196 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 41191 || 4154 || 286 || 12623 || 5310 || 4594 || 2924 || 1773 || 72855

2.b. || Rats || 21280 || 5046 || 78 || 550 || 2228 || 122 || 1525 || 0 || 30829

2.c. || Guinea-Pigs || 1263 || 316 || 0 || 1071 || 600 || 2 || 52 || 0 || 3304

2.d. || Hamsters || 12 || 100 || 0 || 0 || 0 || 0 || 4 || 3 || 119

2.e. || Other Rodents || 1163 || 0 || 0 || 0 || 70 || 0 || 48 || 35 || 1316

2.f. || Rabbits || 1123 || 111 || 69 || 5665 || 418 || 83 || 163 || 45 || 7677

2.g. || Cats || 0 || 56 || 0 || 8 || 112 || 0 || 5 || 0 || 181

2.h. || Dogs || 0 || 1021 || 0 || 118 || 232 || 0 || 15 || 0 || 1386

2.i. || Ferrets || 0 || 185 || 0 || 0 || 8 || 0 || 0 || 0 || 193

2.j. || Other Carnivores || 13 || 0 || 0 || 0 || 32 || 0 || 0 || 0 || 45

2.k. || Horses, donkeys and cross breds || 6 || 170 || 0 || 387 || 11 || 0 || 13 || 8 || 595

2.l. || Pigs || 1042 || 487 || 0 || 556 || 127 || 0 || 71 || 0 || 2283

2.m. || Goats || 62 || 0 || 0 || 0 || 0 || 20 || 18 || 6 || 106

2.n. || Sheep || 646 || 58 || 0 || 92 || 0 || 315 || 36 || 0 || 1147

2.o. || Cattle || 259 || 167 || 0 || 253 || 21 || 20 || 63 || 0 || 783

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.r. || Old World Monkeys || 0 || 28 || 0 || 0 || 0 || 0 || 0 || 2 || 30

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 2477 || 0 || 0 || 182 || 179 || 0 || 0 || 0 || 2838

2.u. || Quail || 161 || 0 || 0 || 0 || 0 || 0 || 69 || 0 || 230

2.v. || Other birds || 162768 || 5608 || 0 || 689 || 0 || 55 || 349 || 792 || 170261

2.w. || Reptiles || 1166 || 0 || 0 || 0 || 0 || 0 || 92 || 0 || 1258

2.x. || Amphibians || 3891 || 0 || 0 || 0 || 0 || 0 || 64 || 34 || 3989

2.y. || Fish || 13772 || 0 || 0 || 0 || 32490 || 284 || 644 || 5581 || 52771

2.z. || TOTAL || 252295 || 17507 || 433 || 22194 || 41838 || 5495 || 6155 || 8279 || 354196

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 4739 || 0 || 62 || 0 || 0 || 0 || 0 || 237 || 272 || 5310

3.b. || Rats || 1366 || 0 || 862 || 0 || 0 || 0 || 0 || 0 || 0 || 2228

3.c. || Guinea-Pigs || 469 || 0 || 131 || 0 || 0 || 0 || 0 || 0 || 0 || 600

3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.e. || Other Rodents || 70 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 70

3.f. || Rabbits || 358 || 0 || 60 || 0 || 0 || 0 || 0 || 0 || 0 || 418

3.g. || Cats || 112 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 112

3.h. || Dogs || 232 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 232

3.i. || Ferrets || 8 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8

3.j. || Other Carnivores || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32

3.k. || Horses, donkeys and cross breds || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11

3.l. || Pigs || 127 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 127

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.o. || Cattle || 21 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 21

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 179 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 179

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 0 || 0 || 560 || 0 || 0 || 0 || 0 || 29102 || 2828 || 32490

3.z. || TOTAL || 7724 || 0 || 1675 || 0 || 0 || 0 || 0 || 29339 || 3100 || 41838

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 1196 || 1873 || 10234 || 13084 || 1008 || 27395

4.b. || Rats || 2107 || 1700 || 2516 || 8609 || 367 || 15299

4.c. || Guinea-Pigs || 0 || 0 || 0 || 141 || 94 || 235

4.d. || Hamsters || 0 || 0 || 0 || 30 || 70 || 100

4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0

4.f. || Rabbits || 116 || 0 || 0 || 390 || 185 || 691

4.g. || Cats || 0 || 0 || 0 || 4 || 52 || 56

4.h. || Dogs || 9 || 0 || 0 || 68 || 944 || 1021

4.i. || Ferrets || 0 || 0 || 0 || 185 || 0 || 185

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 6 || 170 || 176

4.l. || Pigs || 150 || 76 || 24 || 279 || 558 || 1087

4.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0

4.n. || Sheep || 2 || 0 || 0 || 919 || 58 || 979

4.o. || Cattle || 0 || 0 || 0 || 6 || 182 || 188

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.r. || Old World Monkeys || 0 || 0 || 0 || 28 || 0 || 28

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 0 || 2709 || 4157 || 6866

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0

4.y. || Fish || 0 || 0 || 0 || 0 || 697 || 697

4.z. || TOTAL || 3580 || 3649 || 12774 || 26458 || 8542 || 55003

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 3327 || 8742 || 0 || 125 || 0 || 715 || 12909 ||

5.b. || Rats || 61 || 550 || 0 || 17 || 0 || 0 || 628 ||

5.c. || Guinea-Pigs || 326 || 745 || 0 || 0 || 0 || 0 || 1071 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 168 || 5069 || 0 || 0 || 0 || 497 || 5734 ||

5.g. || Cats || 0 || 8 || 0 || 0 || 0 || 0 || 8 ||

5.h. || Dogs || 0 || 118 || 0 || 0 || 0 || 0 || 118 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 338 || 20 || 0 || 0 || 17 || 12 || 387 ||

5.l. || Pigs || 60 || 0 || 0 || 0 || 198 || 0 || 258 ||

5.m. || Goats || 0 || 298 || 0 || 0 || 0 || 0 || 298 ||

5.n. || Sheep || 3 || 0 || 0 || 0 || 76 || 13 || 92 ||

5.o. || Cattle || 0 || 0 || 0 || 0 || 232 || 0 || 232 ||

5.p. || Prosimians || 0 || 21 || 0 || 0 || 0 || 0 || 21 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 68 || 182 || 0 || 15 || 606 || 0 || 871 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.z. || TOTAL || 4351 || 15753 || 0 || 157 || 1129 || 1237 || 22627 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 1030 || 4043 || 0 || 0 || 0 || 237 || 5310 ||

6.b. || Rats || 853 || 1375 || 0 || 0 || 0 || 0 || 2228 ||

6.c. || Guinea-Pigs || 88 || 512 || 0 || 0 || 0 || 0 || 600 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.e. || Other Rodents || 0 || 70 || 0 || 0 || 0 || 0 || 70 ||

6.f. || Rabbits || 89 || 99 || 0 || 0 || 0 || 0 || 188 ||

6.g. || Cats || 0 || 230 || 0 || 0 || 0 || 0 || 230 ||

6.h. || Dogs || 114 || 112 || 0 || 0 || 0 || 0 || 226 ||

6.i. || Ferrets || 0 || 118 || 0 || 0 || 0 || 0 || 118 ||

6.j. || Other Carnivores || 0 || 8 || 0 || 0 || 0 || 0 || 8 ||

6.k. || Horses, donkeys and cross breds || 0 || 32 || 0 || 0 || 0 || 0 || 32 ||

6.l. || Pigs || 0 || 11 || 0 || 0 || 0 || 0 || 11 ||

6.m. || Goats || 0 || 127 || 0 || 0 || 0 || 0 || 127 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.p. || Prosimians || 0 || 21 || 0 || 0 || 0 || 0 || 21 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.v. || Other birds || 0 || 179 || 0 || 0 || 0 || 0 || 179 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 30580 || 1910 || 0 || 0 || 0 || 0 || 32490 ||

6.z. || TOTAL || 32754 || 8847 || 0 || 0 || 0 || 237 || 41838 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 295 || 543 || 429 || 0 || 99 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3944 || 5310

7.b. || Rats || 196 || 853 || 108 || 0 || 0 || 0 || 314 || 0 || 127 || 269 || 280 || 0 || 81 || 2228

7.c. || Guinea-Pigs || 0 || 0 || 0 || 88 || 166 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 346 || 600

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 70 || 70

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 230 || 230

7.f. || Rabbits || 10 || 0 || 29 || 131 || 0 || 18 || 0 || 0 || 0 || 0 || 0 || 0 || 112 || 300

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 118 || 118

7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 122 || 122

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32 || 32

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11 || 11

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 127 || 127

7.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 21 || 21

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 179 || 179

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 20793 || 8909 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2788 || 0 || 32490

7.z. || TOTAL || 21294 || 10305 || 566 || 219 || 265 || 18 || 314 || 0 || 127 || 269 || 280 || 2788 || 5393 || 41838

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 245 || 1396 || 29 || 177 || 78 || 0 || 206 || 0 || 127 || 160 || 0 || 0 || 5306 || 7724

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.c. || Products/substances used or intended to be used mainly in industry || 736 || 0 || 108 || 42 || 187 || 18 || 108 || 0 || 0 || 109 || 280 || 0 || 87 || 1675

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 20181 || 7563 || 157 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1438 || 0 || 29339

8.i. || Other toxicological or safety evaluations || 132 || 1346 || 272 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1350 || 0 || 3100

8.j. || TOTAL || 21294 || 10305 || 566 || 219 || 265 || 18 || 314 || 0 || 127 || 269 || 280 || 2788 || 5393 || 41838

DENMARK

Statistical data submitted

The statistical data were submitted by the 'Dyreforsøgstilsynet' (Animal Experiments Inspectorate).

Comments of Danish authorities

In 2011, 282,840 animals were used for experimental purposes in Denmark, 11,372 more than in 2010. This is a modest increase of 4.2%.

However the number of traditional laboratory animals such as mice and rats decreased from 2010 to 2011 from 154,963 to 141,991 mice and from 69,186 to 67,159 rats. This is probably due to random changes and a general decrease in activity due to financial difficulties in Denmark.

However attention should be drawn to one particular figure: the increase in the use of fish for experimental purposes. From 2010 to 2011 the number of fish increased from 27,780 animals in 2010 to 51,159 animals in 2011. This increase alone almost explains the total increase of animals used for experimental purposes in 2011.

A large portion of the fish – 24,968 - were used for modeling human neurological disorders. But many fish were also used for development of vaccines for fish in aquaculture, potentially reducing the need for antibiotics.

When collecting the statistical information for 2011, the Animal Experiments Inspectorate also asked for data on which and how many of the animals were genetically modified.

A total of 21,961 mice, 60 rats, 50 pigs and 7,278 fish included in the statistics were used for in vivo experimental purposes. Furthermore 13 new genetic modified mice strains and 83 cloned pigs were produced. 12 of the cloned pigs were used in experiments. 4,746 mice not included in the statistics, were used for in vitro experimental purposes.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 141991 || 105803 || 32302 || 14 || 3872 ||

1.b. || Rats (Rattus norvegicus) || 67159 || 41624 || 23412 || 0 || 2123 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 4672 || 290 || 4378 || 0 || 4 ||

1.d. || Hamsters (Mesocricetus ) || 178 || 0 || 90 || 0 || 88 ||

1.e. || Other Rodents (other Rodentia) || 115 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 3602 || 509 || 688 || 0 || 2405 || 82

1.g. || Cats (Felis catus) || 0 || 0 || 0 || 0 || 0 || 0

1.h. || Dogs (Canis familiaris) || 470 || 13 || 426 || 0 || 31 || 51

1.i. || Ferrets (Mustela putorius furo) || 129 || 129 || 0 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 197 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 67 || || || || ||

1.l. || Pigs (Sus) || 8694 || || || || ||

1.m. || Goats (Capra) || 74 || || || || ||

1.n. || Sheep (Ovis) || 191 || || || || ||

1.o. || Cattle (Bos) || 513 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 32 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || 0 || 0 || 0 || 0 ||

1.v. || Other birds (other Aves) || 3245 || || || || ||

1.w. || Reptiles (Reptilia) || 237 || || || || ||

1.x. || Amphibians (Amphibia) || 115 || || || || ||

1.y. || Fish (Pisces) || 51159 || || || || ||

1.z. || TOTAL || 282840 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 50102 || 65748 || 11983 || 200 || 3490 || 1223 || 1540 || 7705 || 141991

2.b. || Rats || 13806 || 38037 || 7700 || 0 || 5190 || 53 || 1724 || 649 || 67159

2.c. || Guinea-Pigs || 187 || 312 || 4015 || 15 || 88 || 0 || 19 || 36 || 4672

2.d. || Hamsters || 88 || 0 || 0 || 0 || 90 || 0 || 0 || 0 || 178

2.e. || Other Rodents || 0 || 115 || 0 || 0 || 0 || 0 || 0 || 0 || 115

2.f. || Rabbits || 114 || 572 || 300 || 56 || 150 || 2405 || 5 || 0 || 3602

2.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.h. || Dogs || 31 || 115 || 0 || 0 || 311 || 0 || 13 || 0 || 470

2.i. || Ferrets || 111 || 18 || 0 || 0 || 0 || 0 || 0 || 0 || 129

2.j. || Other Carnivores || 197 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 197

2.k. || Horses, donkeys and cross breds || 16 || 31 || 4 || 0 || 0 || 0 || 16 || 0 || 67

2.l. || Pigs || 4265 || 1695 || 450 || 40 || 629 || 81 || 950 || 584 || 8694

2.m. || Goats || 0 || 13 || 0 || 0 || 0 || 54 || 0 || 7 || 74

2.n. || Sheep || 80 || 0 || 0 || 0 || 0 || 0 || 44 || 67 || 191

2.o. || Cattle || 392 || 28 || 5 || 5 || 0 || 0 || 83 || 0 || 513

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32

2.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.v. || Other birds || 2950 || 215 || 2 || 72 || 0 || 4 || 2 || 0 || 3245

2.w. || Reptiles || 237 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 237

2.x. || Amphibians || 115 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 115

2.y. || Fish || 41565 || 2855 || 0 || 0 || 600 || 0 || 139 || 6000 || 51159

2.z. || TOTAL || 114288 || 109754 || 24459 || 388 || 10548 || 3820 || 4535 || 15048 || 282840

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 490 || 706 || 2132 || 0 || 0 || 0 || 0 || 0 || 162 || 3490

3.b. || Rats || 2512 || 238 || 156 || 386 || 0 || 216 || 10 || 1656 || 16 || 5190

3.c. || Guinea-Pigs || 58 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 88

3.d. || Hamsters || 90 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 90

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28 || 150

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 308 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3 || 311

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.l. || Pigs || 599 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 629

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 600 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 600

3.z. || TOTAL || 4779 || 944 || 2288 || 386 || 0 || 216 || 10 || 1656 || 269 || 10548

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 2765 || 25452 || 9063 || 45769 || 340 || 83389

4.b. || Rats || 2500 || 24728 || 407 || 17345 || 14 || 44994

4.c. || Guinea-Pigs || 60 || 126 || 0 || 93 || 28 || 307

4.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0

4.e. || Other Rodents || 0 || 0 || 0 || 115 || 0 || 115

4.f. || Rabbits || 0 || 0 || 2405 || 470 || 0 || 2875

4.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0

4.h. || Dogs || 0 || 8 || 27 || 80 || 30 || 145

4.i. || Ferrets || 0 || 0 || 0 || 111 || 0 || 111

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 42 || 42

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 13 || 13

4.l. || Pigs || 469 || 95 || 62 || 2122 || 51 || 2799

4.m. || Goats || 0 || 0 || 54 || 8 || 0 || 62

4.n. || Sheep || 0 || 0 || 0 || 72 || 0 || 72

4.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 20 || 20

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 0 || 117 || 1050 || 1167

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 105 || 0 || 0 || 0 || 105

4.y. || Fish || 0 || 24968 || 0 || 0 || 0 || 24968

4.z. || TOTAL || 5794 || 75482 || 12018 || 66302 || 1588 || 161184

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 0 || 9950 || 0 || 1165 || 1043 || 25 || 12183 ||

5.b. || Rats || 0 || 206 || 0 || 0 || 7494 || 0 || 7700 ||

5.c. || Guinea-Pigs || 15 || 3593 || 0 || 0 || 60 || 362 || 4030 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 12 || 34 || 0 || 0 || 0 || 310 || 356 ||

5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 4 || 4 ||

5.l. || Pigs || 40 || 22 || 0 || 0 || 428 || 0 || 490 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.o. || Cattle || 5 || 0 || 0 || 0 || 0 || 5 || 10 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 72 || 0 || 0 || 0 || 2 || 0 || 74 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.z. || TOTAL || 144 || 13805 || 0 || 1165 || 9027 || 706 || 24847 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 216 || 0 || 0 || 0 || 248 || 3026 || 3490 ||

6.b. || Rats || 303 || 0 || 0 || 0 || 2428 || 2459 || 5190 ||

6.c. || Guinea-Pigs || 22 || 0 || 0 || 0 || 36 || 30 || 88 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 90 || 0 || 90 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 0 || 0 || 0 || 0 || 150 || 0 || 150 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 0 || 0 || 0 || 0 || 311 || 0 || 311 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.l. || Pigs || 0 || 0 || 0 || 0 || 629 || 0 || 629 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 0 || 0 || 0 || 0 || 0 || 600 || 600 ||

6.z. || TOTAL || 541 || 0 || 0 || 0 || 3892 || 6115 || 10548 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 0 || 706 || 275 || 6 || 102 || 0 || 78 || 107 || 0 || 101 || 0 || 0 || 2115 || 3490

7.b. || Rats || 0 || 0 || 1340 || 196 || 32 || 0 || 1184 || 48 || 0 || 96 || 1952 || 0 || 342 || 5190

7.c. || Guinea-Pigs || 0 || 0 || 22 || 0 || 0 || 0 || 36 || 0 || 0 || 0 || 0 || 0 || 30 || 88

7.d. || Hamsters || 0 || 0 || 90 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 90

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 39 || 66 || 0 || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 150

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 2 || 0 || 0 || 0 || 309 || 0 || 0 || 0 || 0 || 0 || 0 || 311

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.l. || Pigs || 0 || 0 || 4 || 0 || 0 || 0 || 531 || 0 || 0 || 0 || 86 || 0 || 8 || 629

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 600 || 600

7.z. || TOTAL || 0 || 706 || 1772 || 268 || 134 || 0 || 2183 || 155 || 0 || 197 || 2038 || 0 || 3095 || 10548

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 0 || 0 || 1758 || 240 || 134 || 0 || 1924 || 0 || 0 || 29 || 86 || 0 || 608 || 4779

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 706 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 238 || 0 || 0 || 944

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 4 || 0 || 168 || 56 || 0 || 2060 || 2288

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 46 || 0 || 340 || 386

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 216 || 0 || 0 || 0 || 0 || 0 || 0 || 216

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 10

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 44 || 0 || 0 || 1612 || 0 || 0 || 1656

8.i. || Other toxicological or safety evaluations || 0 || 0 || 14 || 28 || 0 || 0 || 33 || 107 || 0 || 0 || 0 || 0 || 87 || 269

8.j. || TOTAL || 0 || 706 || 1772 || 268 || 134 || 0 || 2183 || 155 || 0 || 197 || 2038 || 0 || 3095 || 10548

GERMANY

Statistical data submitted

The statistical data were submitted by the 'Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft' (Federal Ministry for Consumer protection, Food and Agriculture).

Comments of German authorities

In 2011, a total of 2,073,702 vertebrates were used in Germany for experimental and other scientific purposes. This is a decrease of 4,338 animals compared to the previous year. This means that for the second time in a row, the number of animals used for the first time has decreased from the previous year. Almost 87% of the test animals used were rodents, primarily mice and rats. Fish accounted for 6%, and rabbits for 4%. While there was an increase particularly in the numbers of mice, fish and sheep used, there were also some decreases, including for rats, birds, dogs, cats and monkeys.

60% of the animals were used to research diseases in humans or animals.

With regard to the purposes of the experiments, there was an increase of 2.7% in basic biological research, 4.4% in the production and quality control of medical products and 0.5% in toxicological testing or other safety testing. On the other hand, there was a decrease of 10.1% in their use in the research and development of products and equipment for medicine, dentistry and veterinary medicine, and a decrease of 21.7% in the diagnosis of diseases.

The current state of scientific knowledge means that experiments on animals cannot be dispensed with altogether, despite the increased use of alternative methods. The German Government nevertheless aims to limit these to the extent they cannot be avoided and, in cases where animal testing is currently indispensable, to ensure that the conditions in which the animals are kept and used are in line with animal protection laws. Despite this, all efforts must continue to be made to replace animal testing with alternative methods whenever possible.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 1 451 046 || 1 242 489 || 193 228 || 6 894 || 8 435 ||

1.b. || Rats (Rattus norvegicus) || 312 740 || 216 556 || 95 205 || 72 || 907 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 24 258 || 23 177 || 990 || 17 || 74 ||

1.d. || Hamsters (Mesocricetus ) || 4 187 || 3 391 || 592 || 0 || 204 ||

1.e. || Other Rodents (other Rodentia) || 4 111 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 87 303 || 85 679 || 1 616 || 0 || 8 || 1 857

1.g. || Cats (Felis catus) || 585 || 214 || 182 || 0 || 189 || 328

1.h. || Dogs (Canis familiaris) || 2 474 || 832 || 750 || 0 || 892 || 1 015

1.i. || Ferrets (Mustela putorius furo) || 96 || 6 || 15 || 40 || 35 || 0

1.j. || Other Carnivores (other Carnivora) || 262 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 1 140 || || || || ||

1.l. || Pigs (Sus) || 15 090 || || || || ||

1.m. || Goats (Capra) || 394 || || || || ||

1.n. || Sheep (Ovis) || 3 287 || || || || ||

1.o. || Cattle (Bos) || 4 300 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 80

1.q. || New World Monkeys (Ceboidea) || 191 || 157 || 5 || 0 || 29 || 219

1.r. || Old World Monkeys (Cercopithecoidea) || 1 579 || 244 || 1 331 || 0 || 4 || 848

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 1 154 || || || || ||

1.u. || Quail (Coturnix coturnix) || 2 821 || 2 821 || 0 || 0 || 0 ||

1.v. || Other birds (other Aves) || 31 271 || || || || ||

1.w. || Reptiles (Reptilia) || 1 011 || || || || ||

1.x. || Amphibians (Amphibia) || 4 453 || || || || ||

1.y. || Fish (Pisces) || 119 949 || || || || ||

1.z. || TOTAL || 2 073 702 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 860 843 || 322 810 || 101 215 || 9 430 || 63 820 || 9 816 || 42 134 || 40 978 || 1 451 046

2.b. || Rats || 65 804 || 128 824 || 46 788 || 3 637 || 48 180 || 415 || 16 370 || 2 722 || 312 740

2.c. || Guinea-Pigs || 815 || 4 102 || 13 642 || 655 || 3 875 || 10 || 393 || 766 || 24 258

2.d. || Hamsters || 1 082 || 2 375 || 49 || 0 || 66 || 0 || 159 || 456 || 4 187

2.e. || Other Rodents || 1 775 || 1 451 || 0 || 0 || 0 || 461 || 189 || 235 || 4 111

2.f. || Rabbits || 1 193 || 3 574 || 78 308 || 854 || 2 115 || 56 || 239 || 964 || 87 303

2.g. || Cats || 35 || 369 || 71 || 1 || 66 || 5 || 14 || 24 || 585

2.h. || Dogs || 25 || 954 || 0 || 0 || 1 260 || 197 || 26 || 12 || 2 474

2.i. || Ferrets || 87 || 9 || 0 || 0 || 0 || 0 || 0 || 0 || 96

2.j. || Other Carnivores || 49 || 0 || 0 || 213 || 0 || 0 || 0 || 0 || 262

2.k. || Horses, donkeys and cross breds || 305 || 302 || 0 || 23 || 0 || 424 || 57 || 29 || 1 140

2.l. || Pigs || 2 878 || 6 616 || 92 || 556 || 339 || 2 096 || 2 287 || 226 || 15 090

2.m. || Goats || 97 || 185 || 6 || 0 || 2 || 9 || 90 || 5 || 394

2.n. || Sheep || 772 || 974 || 1 166 || 6 || 19 || 64 || 179 || 107 || 3 287

2.o. || Cattle || 1 063 || 839 || 6 || 730 || 32 || 730 || 802 || 98 || 4 300

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 82 || 11 || 0 || 0 || 0 || 0 || 0 || 98 || 191

2.r. || Old World Monkeys || 36 || 56 || 0 || 0 || 1 072 || 0 || 199 || 216 || 1 579

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 1 117 || 0 || 4 || 0 || 0 || 0 || 26 || 7 || 1 154

2.u. || Quail || 10 || 0 || 0 || 0 || 2 804 || 0 || 7 || 0 || 2 821

2.v. || Other birds || 11 559 || 5 602 || 8 334 || 791 || 424 || 1 507 || 608 || 2 446 || 31 271

2.w. || Reptiles || 569 || 14 || 0 || 0 || 0 || 412 || 16 || 0 || 1 011

2.x. || Amphibians || 3 303 || 34 || 0 || 0 || 140 || 5 || 734 || 237 || 4 453

2.y. || Fish || 64 436 || 364 || 0 || 60 || 50 442 || 117 || 3 201 || 1 329 || 119 949

2.z. || TOTAL || 1 017 935 || 479 465 || 249 681 || 16 956 || 174 656 || 16 324 || 67 730 || 50 955 || 2 073 702

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 50 679 || 4 858 || 7 922 || 0 || 0 || 0 || 0 || 40 || 321 || 63 820

3.b. || Rats || 24 817 || 8 943 || 13 234 || 135 || 0 || 0 || 0 || 787 || 264 || 48 180

3.c. || Guinea-Pigs || 2 594 || 676 || 509 || 76 || 0 || 0 || 0 || 0 || 20 || 3 875

3.d. || Hamsters || 16 || 0 || 50 || 0 || 0 || 0 || 0 || 0 || 0 || 66

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 1 593 || 342 || 178 || 2 || 0 || 0 || 0 || 0 || 0 || 2 115

3.g. || Cats || 66 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 66

3.h. || Dogs || 1 166 || 94 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 260

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.l. || Pigs || 339 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 339

3.m. || Goats || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2

3.n. || Sheep || 19 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 19

3.o. || Cattle || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 1 072 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 072

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 2 804 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 804

3.v. || Other birds || 40 || 342 || 0 || 0 || 0 || 0 || 0 || 0 || 42 || 424

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 140 || 0 || 140

3.y. || Fish || 3 994 || 14 444 || 2 890 || 0 || 0 || 0 || 0 || 28 994 || 120 || 50 442

3.z. || TOTAL || 86 427 || 32 505 || 24 783 || 213 || 0 || 0 || 0 || 29 961 || 767 || 174 656

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 104 726 || 175 441 || 267 231 || 464 178 || 5 571 || 1 017 147

4.b. || Rats || 31 810 || 57 964 || 9 645 || 82 775 || 1 198 || 183 392

4.c. || Guinea-Pigs || 519 || 197 || 18 || 3 031 || 53 || 3 818

4.d. || Hamsters || 1 549 || 5 || 56 || 1 343 || 0 || 2 953

4.e. || Other Rodents || 0 || 193 || 0 || 1 587 || 951 || 2 731

4.f. || Rabbits || 1 257 || 137 || 131 || 2 359 || 273 || 4 157

4.g. || Cats || 0 || 7 || 0 || 9 || 378 || 394

4.h. || Dogs || 239 || 6 || 7 || 115 || 654 || 1 021

4.i. || Ferrets || 0 || 6 || 0 || 90 || 0 || 96

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 29 || 29

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 17 || 976 || 993

4.l. || Pigs || 2 219 || 113 || 55 || 1 403 || 5 358 || 9 148

4.m. || Goats || 9 || 15 || 0 || 138 || 79 || 241

4.n. || Sheep || 245 || 63 || 0 || 828 || 508 || 1 644

4.o. || Cattle || 5 || 0 || 0 || 289 || 1 421 || 1 715

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 7 || 33 || 0 || 44 || 0 || 84

4.r. || Old World Monkeys || 8 || 4 || 17 || 32 || 0 || 61

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 141 || 0 || 50 || 1 || 192

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 108 || 0 || 0 || 1 460 || 7 032 || 8 600

4.w. || Reptiles || 0 || 39 || 0 || 0 || 462 || 501

4.x. || Amphibians || 438 || 91 || 0 || 629 || 5 || 1 163

4.y. || Fish || 1 248 || 2 823 || 371 || 5 330 || 553 || 10 325

4.z. || TOTAL || 144 387 || 237 278 || 277 531 || 565 707 || 25 502 || 1 250 405

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 0 || 90 686 || 0 || 16 092 || 80 || 3 787 || 110 645 ||

5.b. || Rats || 0 || 49 838 || 0 || 0 || 196 || 391 || 50 425 ||

5.c. || Guinea-Pigs || 0 || 13 842 || 0 || 185 || 11 || 259 || 14 297 ||

5.d. || Hamsters || 0 || 49 || 0 || 0 || 0 || 0 || 49 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 0 || 42 872 || 0 || 0 || 1 352 || 34 938 || 79 162 ||

5.g. || Cats || 0 || 71 || 0 || 0 || 0 || 1 || 72 ||

5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 213 || 0 || 0 || 0 || 0 || 213 ||

5.k. || Horses, donkeys and cross breds || 0 || 17 || 0 || 0 || 0 || 6 || 23 ||

5.l. || Pigs || 75 || 470 || 0 || 0 || 0 || 103 || 648 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 6 || 6 ||

5.n. || Sheep || 24 || 0 || 0 || 0 || 0 || 1 148 || 1 172 ||

5.o. || Cattle || 0 || 730 || 0 || 0 || 0 || 6 || 736 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 4 || 4 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 0 || 869 || 0 || 0 || 8 057 || 199 || 9 125 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 60 || 60 ||

5.z. || TOTAL || 99 || 199 657 || 0 || 16 277 || 9 696 || 40 908 || 266 637 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 89 || 54 028 || 0 || 0 || 8 673 || 1 030 || 63 820 ||

6.b. || Rats || 361 || 24 238 || 0 || 299 || 20 199 || 3 083 || 48 180 ||

6.c. || Guinea-Pigs || 0 || 3 279 || 0 || 0 || 596 || 0 || 3 875 ||

6.d. || Hamsters || 0 || 66 || 0 || 0 || 0 || 0 || 66 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 0 || 1 453 || 0 || 0 || 662 || 0 || 2 115 ||

6.g. || Cats || 28 || 38 || 0 || 0 || 0 || 0 || 66 ||

6.h. || Dogs || 2 || 573 || 0 || 94 || 577 || 14 || 1 260 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.l. || Pigs || 0 || 236 || 0 || 0 || 99 || 4 || 339 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 2 || 0 || 2 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 19 || 0 || 19 ||

6.o. || Cattle || 0 || 32 || 0 || 0 || 0 || 0 || 32 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 234 || 0 || 0 || 838 || 0 || 1 072 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 370 || 0 || 0 || 2 434 || 0 || 2 804 ||

6.v. || Other birds || 0 || 50 || 0 || 0 || 292 || 82 || 424 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 140 || 140 ||

6.y. || Fish || 556 || 7 143 || 0 || 120 || 20 435 || 22 188 || 50 442 ||

6.z. || TOTAL || 1 036 || 91 740 || 0 || 513 || 54 826 || 26 541 || 174 656 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 27 634 || 1 829 || 6 599 || 0 || 7 771 || 0 || 1 222 || 1 054 || 130 || 5 644 || 342 || 0 || 11 595 || 63 820

7.b. || Rats || 1 818 || 2 545 || 15 606 || 560 || 0 || 0 || 5 848 || 1 880 || 2 546 || 2 930 || 6 778 || 0 || 7 669 || 48 180

7.c. || Guinea-Pigs || 20 || 0 || 0 || 0 || 3 417 || 0 || 0 || 0 || 0 || 0 || 254 || 0 || 184 || 3 875

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 50 || 0 || 0 || 16 || 66

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 73 || 281 || 15 || 180 || 19 || 0 || 138 || 0 || 1 043 || 0 || 366 || 2 115

7.g. || Cats || 0 || 0 || 32 || 0 || 0 || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 22 || 66

7.h. || Dogs || 0 || 123 || 318 || 0 || 0 || 0 || 386 || 0 || 0 || 0 || 0 || 0 || 433 || 1 260

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.l. || Pigs || 0 || 39 || 114 || 0 || 0 || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 174 || 339

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 2

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 19 || 19

7.o. || Cattle || 0 || 0 || 16 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 16 || 32

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 208 || 0 || 0 || 0 || 465 || 0 || 266 || 0 || 15 || 0 || 118 || 1 072

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 164 || 370 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 270 || 2 804

7.v. || Other birds || 55 || 0 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 349 || 424

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 140 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 140

7.y. || Fish || 2 451 || 0 || 0 || 0 || 0 || 0 || 5 396 || 0 || 8 170 || 0 || 2 502 || 29 895 || 2 028 || 50 442

7.z. || TOTAL || 32 142 || 4 906 || 23 126 || 841 || 11 203 || 180 || 13 360 || 2 934 || 11 250 || 8 624 || 10 934 || 29 895 || 25 261 || 174 656

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 28 254 || 2 446 || 14 560 || 71 || 4 465 || 46 || 5 635 || 1 174 || 2 114 || 2 644 || 4 250 || 1 671 || 19 097 || 86 427

8.b. || Products/substances used or intended to be used mainly in agriculture || 2 097 || 2 312 || 2 313 || 96 || 1 408 || 87 || 852 || 1 140 || 7 078 || 2 185 || 3 735 || 4 567 || 4 635 || 32 505

8.c. || Products/substances used or intended to be used mainly in industry || 1 569 || 110 || 5 891 || 674 || 5 059 || 45 || 1 397 || 0 || 748 || 3 634 || 2 949 || 1 866 || 841 || 24 783

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 55 || 0 || 76 || 2 || 80 || 0 || 0 || 0 || 0 || 0 || 0 || 213

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 172 || 38 || 307 || 0 || 0 || 0 || 5 396 || 620 || 1 310 || 0 || 0 || 21 791 || 327 || 29 961

8.i. || Other toxicological or safety evaluations || 50 || 0 || 0 || 0 || 195 || 0 || 0 || 0 || 0 || 161 || 0 || 0 || 361 || 767

8.j. || TOTAL || 32 142 || 4 906 || 23 126 || 841 || 11 203 || 180 || 13 360 || 2 934 || 11 250 || 8 624 || 10 934 || 29 895 || 25 261 || 174 656

COMMISSION STAFF WORKING DOCUMENT

Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

PART B II: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATE

TABLE OF CONTENTS

ESTONIA................................................................................................................................... 5

IRELAND................................................................................................................................ 16

GREECE.................................................................................................................................. 27

SPAIN...................................................................................................................................... 37

ESTONIA

Statistical data submitted

The statistical data were submitted by the Animal Welfare and Zootechnics bureau of the Ministry of Agriculture.

Comments of Estonian authorities

Estonia has 10 approved experimental animal breeding and user establishments. Six of them are active at the University of Tartu.

Commission of the authorization of the animal testing permits first started in August 2004.

During the period 2009-2011 there have been issued 92 licenses for conducting animal experiments in Estonia. Most of the experiments have been conducted at the University of Tartu.

The majority of laboratory animals used are from authorized breeding establishments in Estonia.

Most experiments have been carried out in the development of products and devices for human medicine and fields of biological studies of a fundamental nature and research.

In the field of biological studies, the majority of experiments involved the investigation of human diseases (nervous and mental illnesses, various forms of cancer). The authorization and licensing animal testing and conducting animal experiments is regulated by national and EU legislation.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 26048 || 3379 || 21109 || 0 || 1560 ||

1.b. || Rats (Rattus norvegicus) || 2556 || 500 || 2056 || 0 || 0 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 72 || 0 || 72 || 0 || 0 ||

1.d. || Hamsters (Mesocricetus ) || 120 || 0 || 120 || 0 || 0 ||

1.e. || Other Rodents (other Rodentia) || 0 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 3 || 3 || 0 || 0 || 0 || 0

1.g. || Cats (Felis catus) || 0 || 0 || 0 || 0 || 0 || 0

1.h. || Dogs (Canis familiaris) || 0 || 0 || 0 || 0 || 0 || 0

1.i. || Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 0 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 40 || || || || ||

1.l. || Pigs (Sus) || 325 || || || || ||

1.m. || Goats (Capra) || 0 || || || || ||

1.n. || Sheep (Ovis) || 0 || || || || ||

1.o. || Cattle (Bos) || 6750 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || 20 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 701 || || || || ||

1.w. || Reptiles (Reptilia) || 0 || || || || ||

1.x. || Amphibians (Amphibia) || 0 || || || || ||

1.y. || Fish (Pisces) || 4400 || || || || ||

1.z. || TOTAL || 41035 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 8631 || 17357 || 0 || 0 || 60 || 0 || 0 || 0 || 26048

2.b. || Rats || 1664 || 892 || 0 || 0 || 0 || 0 || 0 || 0 || 2556

2.c. || Guinea-Pigs || 72 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 72

2.d. || Hamsters || 0 || 120 || 0 || 0 || 0 || 0 || 0 || 0 || 120

2.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.f. || Rabbits || 0 || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 3

2.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.k. || Horses, donkeys and cross breds || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 40

2.l. || Pigs || 0 || 83 || 0 || 0 || 242 || 0 || 0 || 0 || 325

2.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.o. || Cattle || 6710 || 0 || 0 || 0 || 24 || 16 || 0 || 0 || 6750

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20

2.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.v. || Other birds || 216 || 0 || 0 || 0 || 485 || 0 || 0 || 0 || 701

2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.y. || Fish || 400 || 4000 || 0 || 0 || 0 || 0 || 0 || 0 || 4400

2.z. || TOTAL || 17753 || 22455 || 0 || 0 || 811 || 16 || 0 || 0 || 41035

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 60 || || || || || || || || || 60

3.b. || Rats || 0 || || || || || || || || || 0

3.c. || Guinea-Pigs || 0 || || || || || || || || || 0

3.d. || Hamsters || 0 || || || || || || || || || 0

3.e. || Other Rodents || 0 || || || || || || || || || 0

3.f. || Rabbits || 0 || || || || || || || || || 0

3.g. || Cats || 0 || || || || || || || || || 0

3.h. || Dogs || 0 || || || || || || || || || 0

3.i. || Ferrets || 0 || || || || || || || || || 0

3.j. || Other Carnivores || 0 || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || 0 || || || || || || || || || 0

3.l. || Pigs || 242 || || || || || || || || || 242

3.m. || Goats || 0 || || || || || || || || || 0

3.n. || Sheep || 0 || || || || || || || || || 0

3.o. || Cattle || 24 || || || || || || || || || 24

3.p. || Prosimians || 0 || || || || || || || || || 0

3.q. || New World Monkeys || 0 || || || || || || || || || 0

3.r. || Old World Monkeys || 0 || || || || || || || || || 0

3.s. || Apes || 0 || || || || || || || || || 0

3.t. || Other Mammals || 0 || || || || || || || || || 0

3.u. || Quail || 0 || || || || || || || || || 0

3.v. || Other birds || 485 || || || || || || || || || 485

3.w. || Reptiles || 0 || || || || || || || || || 0

3.x. || Amphibians || 0 || || || || || || || || || 0

3.y. || Fish || 0 || || || || || || || || || 0

3.z. || TOTAL || 811 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 811

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 0 || 4450 || 7588 || 5719 || 0 || 17757

4.b. || Rats || 40 || 596 || 6 || 250 || 0 || 892

4.c. || Guinea-Pigs || 0 || 0 || 0 || 32 || 0 || 32

4.d. || Hamsters || 0 || 0 || 0 || 120 || 0 || 120

4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0

4.f. || Rabbits || 0 || 0 || 0 || 3 || 0 || 3

4.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0

4.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0

4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0

4.l. || Pigs || 0 || 0 || 0 || 83 || 0 || 83

4.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0

4.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0

4.o. || Cattle || 0 || 0 || 0 || 0 || 10 || 10

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 0 || 0 || 36 || 36

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0

4.y. || Fish || 0 || 0 || 0 || 0 || 4000 || 4000

4.z. || TOTAL || 40 || 5046 || 7594 || 6207 || 4046 || 22933

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

                                                                                          Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || 0 || || 0 ||

5.b. || Rats || || || || || 0 || || 0 ||

5.c. || Guinea-Pigs || || || || || 0 || || 0 ||

5.d. || Hamsters || || || || || 0 || || 0 ||

5.e. || Other Rodents || || || || || 0 || || 0 ||

5.f. || Rabbits || || || || || 0 || || 0 ||

5.g. || Cats || || || || || 0 || || 0 ||

5.h. || Dogs || || || || || 0 || || 0 ||

5.i. || Ferrets || || || || || 0 || || 0 ||

5.j. || Other Carnivores || || || || || 0 || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || 0 || || 0 ||

5.l. || Pigs || || || || || 0 || || 0 ||

5.m. || Goats || || || || || 0 || || 0 ||

5.n. || Sheep || || || || || 0 || || 0 ||

5.o. || Cattle || || || || || 0 || || 0 ||

5.p. || Prosimians || || || || || 0 || || 0 ||

5.q. || New World Monkeys || || || || || 0 || || 0 ||

5.r. || Old World Monkeys || || || || || 0 || || 0 ||

5.s. || Apes || || || || || 0 || || 0 ||

5.t. || Other Mammals || || || || || 0 || || 0 ||

5.u. || Quail || || || || || 0 || || 0 ||

5.v. || Other birds || || || || || 0 || || 0 ||

5.w. || Reptiles || || || || || 0 || || 0 ||

5.x. || Amphibians || || || || || 0 || || 0 ||

5.y. || Fish || || || || || 0 || || 0 ||

5.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || || || || 60 || || 60 ||

6.b. || Rats || || || || || 0 || || 0 ||

6.c. || Guinea-Pigs || || || || || 0 || || 0 ||

6.d. || Hamsters || || || || || 0 || || 0 ||

6.e. || Other Rodents || || || || || 0 || || 0 ||

6.f. || Rabbits || || || || || 0 || || 0 ||

6.g. || Cats || || || || || 0 || || 0 ||

6.h. || Dogs || || || || || 0 || || 0 ||

6.i. || Ferrets || || || || || 0 || || 0 ||

6.j. || Other Carnivores || || || || || 0 || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || 0 || || 0 ||

6.l. || Pigs || || || || || 242 || || 242 ||

6.m. || Goats || || || || || 0 || || 0 ||

6.n. || Sheep || || || || || 0 || || 0 ||

6.o. || Cattle || || || || || 24 || || 24 ||

6.p. || Prosimians || || || || || 0 || || 0 ||

6.q. || New World Monkeys || || || || || 0 || || 0 ||

6.r. || Old World Monkeys || || || || || 0 || || 0 ||

6.s. || Apes || || || || || 0 || || 0 ||

6.t. || Other Mammals || || || || || 0 || || 0 ||

6.u. || Quail || || || || || 0 || || 0 ||

6.v. || Other birds || || || || || 485 || || 485 ||

6.w. || Reptiles || || || || || 0 || || 0 ||

6.x. || Amphibians || || || || || 0 || || 0 ||

6.y. || Fish || || || || || 0 || || 0 ||

6.z. || TOTAL || 0 || 0 || 0 || 0 || 811 || 0 || 811 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || || 60 || || || || || || || || || || || 60

7.b. || Rats || || || 0 || || || || || || || || || || || 0

7.c. || Guinea-Pigs || || || 0 || || || || || || || || || || || 0

7.d. || Hamsters || || || 0 || || || || || || || || || || || 0

7.e. || Other Rodents || || || 0 || || || || || || || || || || || 0

7.f. || Rabbits || || || 0 || || || || || || || || || || || 0

7.g. || Cats || || || 0 || || || || || || || || || || || 0

7.h. || Dogs || || || 0 || || || || || || || || || || || 0

7.i. || Ferrets || || || 0 || || || || || || || || || || || 0

7.j. || Other Carnivores || || || 0 || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || 0 || || || || || || || || || || || 0

7.l. || Pigs || || || 242 || || || || || || || || || || || 242

7.m. || Goats || || || 0 || || || || || || || || || || || 0

7.n. || Sheep || || || 0 || || || || || || || || || || || 0

7.o. || Cattle || || || 24 || || || || || || || || || || || 24

7.p. || Prosimians || || || 0 || || || || || || || || || || || 0

7.q. || New World Monkeys || || || 0 || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || 0 || || || || || || || || || || || 0

7.s. || Apes || || || 0 || || || || || || || || || || || 0

7.t. || Other Mammals || || || 0 || || || || || || || || || || || 0

7.u. || Quail || || || 0 || || || || || || || || || || || 0

7.v. || Other birds || || || 485 || || || || || || || || || || || 485

7.w. || Reptiles || || || 0 || || || || || || || || || || || 0

7.x. || Amphibians || || || 0 || || || || || || || || || || || 0

7.y. || Fish || || || 0 || || || || || || || || || || || 0

7.z. || TOTAL || 0 || 0 || 811 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 811

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || 811 || || || || || || || || || || || 811

8.b. || Products/substances used or intended to be used mainly in agriculture || || || 0 || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || 0 || || || || || || || || || || || 0

8.d. || Products/substances used or intended to be used mainly in the household || || || 0 || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || 0 || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || 0 || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || 0 || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || 0 || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || || || 0 || || || || || || || || || || || 0

8.j. || TOTAL || 0 || 0 || 811 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 811

IRELAND

Statistical data submitted

The statistical data for Ireland were provided by the Department of Health.

Comments of Irish authorities[1]

General

· A total of 264,990 animals were used. This represents an increase of 135% compared to the 112,835 animals used in 2008.

· 131 new licences were issued in 2011. This is a reduction of 49% on the 259 licences issued in 2008. In this context, a change in procedures, whereby licences are issued to the project leader rather than each researcher working on the project, contributed to this reduction.

· Rodents accounted for 98% (259,879) of all animals used which compares to 74% (83,124) of all animals in 2008.

· No primates were used. This was in accordance with Ireland’s policy not to licence for the use of primates.

· Of the animals used, 7% (17,739) were bred in registered breeding establishments in Ireland while 6% (16,955) came from other Member States in the EU and 86% (228,688) came from Non-EU Member States of the Council of Europe which are parties to Convention ETS 123. When rodents are excluded from this analysis, the % of animals bred in registered breeding establishments in Ireland rises to 72%.

· Regulatory requirements (195,649) and studies related to human and animal diseases (67,977) accounted for 99.5% of all animals used in scientific procedures.

Animals Used for Selected Purposes

· Of the 264,990 animals used, 67,977 (26%) were involved in studies on human and animal diseases.

· Of the 259,979 rodents used, 64,883 (25%) were involved in studies on human and animal diseases.

· Of the 473 dogs used, 361 (76%) were involved in studies specific to animal diseases.

· Of the 120 cats, 64 (53%) were involved in studies specific to animal diseases.

· Of the 238 horses, donkeys and crossbreds used, 216 (91%) were involved in studies specific to animal diseases.

· Of the 348 sheep used, 317 (91%) were involved in studies specific to animal diseases.

· Of the 1,700 cattle used, 942 (55%) were involved in studies on human and animal diseases.

· All “other mammals” (480) were involved in studies specific to animal diseases.

· Of the 503 “other birds” used, 463 (92%) were involved in studies specific to animal diseases.

Toxicological and other Safety Evaluations

· No animals were used in the testing of cosmetic products. This was in accordance with Ireland’s policy not to licence procedures involving the testing of cosmetics.

· Toxicological and other safety evaluations accounted for 74% (195,446) of animals used which compares with 52,065 (46%) in 2008.

· 195,309 (99.9%) of toxicological and other safety evaluations were done pursuant to regulatory requirements.

· 194,607 (99.6%) of the animals used in toxicological and other safety evaluations were rodents.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 248958 || 11182 || 12986 || 223996 || 794 ||

1.b. || Rats (Rattus norvegicus) || 10476 || 2952 || 3781 || 3595 || 148 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 545 || || 96 || 449 || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 715 || 30 || 47 || 638 || || 177

1.g. || Cats (Felis catus) || 120 || 120 || || || || 59

1.h. || Dogs (Canis familiaris) || 473 || 473 || || || || 120

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 238 || || || || ||

1.l. || Pigs (Sus) || 286 || || || || ||

1.m. || Goats (Capra) || 39 || || || || ||

1.n. || Sheep (Ovis) || 348 || || || || ||

1.o. || Cattle (Bos) || 1700 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || 480 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 503 || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || 21 || || || || ||

1.y. || Fish (Pisces) || 88 || || || || ||

1.z. || TOTAL || 264990 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 20283 || 33835 || 184 || || 194158 || 269 || 15 || 214 || 248958

2.b. || Rats || 5659 || 4624 || || || || 117 || 4 || 72 || 10476

2.c. || Guinea-Pigs || || 96 || || || 449 || || || || 545

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || 35 || 45 || || || 635 || || || || 715

2.g. || Cats || || 64 || || || 56 || || || || 120

2.h. || Dogs || || 361 || || || 112 || || || || 473

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || 7 || || || 22 || || 209 || || || 238

2.l. || Pigs || 5 || 54 || 7 || || 36 || || || 184 || 286

2.m. || Goats || || 39 || || || || || || || 39

2.n. || Sheep || 317 || || || || || || 2 || 29 || 348

2.o. || Cattle || 904 || 24 || || 134 || || 14 || 550 || 74 || 1700

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || 480 || || || || || || || 480

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || 463 || || 40 || 503

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || 21 || || || || || || || || 21

2.y. || Fish || 52 || || || || || || || 36 || 88

2.z. || TOTAL || 27283 || 39622 || 191 || 156 || 195446 || 1072 || 571 || 649 || 264990

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 105 || || || || || || || || 194053 || 194158

3.b. || Rats || || || || || || || || || || 0

3.c. || Guinea-Pigs || || || || || || || || || 449 || 449

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || || || || || || || || || 635 || 635

3.g. || Cats || 56 || || || || || || || || || 56

3.h. || Dogs || 112 || || || || || || || || || 112

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || 36 || || || 36

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 273 || 0 || 0 || 0 || 0 || 0 || 36 || 0 || 195137 || 195446

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 1387 || 9044 || 1927 || 41831 || 198 || 54387

4.b. || Rats || 746 || 4273 || || 5381 || || 10400

4.c. || Guinea-Pigs || || 26 || || 22 || 48 || 96

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || 17 || || || 63 || || 80

4.g. || Cats || || || || || 64 || 64

4.h. || Dogs || || || || || 361 || 361

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || 216 || 216

4.l. || Pigs || 52 || || 5 || || 2 || 59

4.m. || Goats || || || || 26 || 13 || 39

4.n. || Sheep || || || || || 317 || 317

4.o. || Cattle || 193 || || || || 749 || 942

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || 480 || 480

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || 463 || 463

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || 21 || 21

4.y. || Fish || || || || 40 || 12 || 52

4.z. || TOTAL || 2395 || 13343 || 1932 || 47363 || 2944 || 67977

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 54 || 130 || || || || || 184 ||

5.b. || Rats || || || || || || || 0 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || || || || || || 0 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || 22 || || || || || 22 ||

5.l. || Pigs || || || || || || 7 || 7 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || 134 || || || || || 134 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 54 || 286 || 0 || 0 || 0 || 7 || 347 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 20 || 624 || || || 193429 || 85 || 194158 ||

6.b. || Rats || || || || || || || 0 ||

6.c. || Guinea-Pigs || || || || || 449 || || 449 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || || || || 635 || || 635 ||

6.g. || Cats || 40 || || || || || 16 || 56 ||

6.h. || Dogs || 80 || 32 || || || || || 112 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || || 36 || 36 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || || || || || || 0 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || || 0 ||

6.y. || Fish || || || || || || || 0 ||

6.z. || TOTAL || 140 || 656 || 0 || 0 || 194513 || 137 || 195446 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 175812 || 624 || 20 || || || || 85 || || || || || || 17617 || 194158

7.b. || Rats || || || || || || || || || || || || || || 0

7.c. || Guinea-Pigs || || || || || || || || || || || || || 449 || 449

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || || || || || || || || || || || 635 || 635

7.g. || Cats || || || || || || || || || || || || || 56 || 56

7.h. || Dogs || || || || || || || || || || || || || 112 || 112

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || 36 || 36

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || || || || || || || || 0

7.z. || TOTAL || 175812 || 624 || 20 || 0 || 0 || 0 || 85 || 0 || 0 || 0 || 0 || 0 || 18905 || 195446

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || 20 || || || || 85 || || || || || || 168 || 273

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || 36 || 36

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || 175812 || 624 || || || || || || || || || || || 18701 || 195137

8.j. || TOTAL || 175812 || 624 || 20 || 0 || 0 || 0 || 85 || 0 || 0 || 0 || 0 || 0 || 18905 || 195446

GREECE

Statistical data submitted

The statistical data were submitted by the 'ΥΠΟΥΡΓΕΙΟ ΓΕΩΡΓΙΑΣ ΓΕΝΙΚΗ Δ/ΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ' (Ministry of Rural Development and Food, Directorate for Veterinary Care, Drugs & Practice).

Comments of Greek authorities

The legal basis for the collection of statistics on the number and use of vertebrate animals for experimental and other scientific purposes in Greece is provided by:

- Presidential Decree No 160/91 (Government Gazette, Series I, No 64) on the protection of animals used for experimental and other scientific purposes, in accordance with Council Directive 86/609/EEC, and

- Law No 2015/92 (Government Gazette, Series I, No 30) approving the European Convention on the protection of animals used for experimental and other scientific purposes.

For the collection of statistics relating to the year 2011, the tables, data and glossary of terms set out in European Commission document EL/11/97/04100000 W00 of 24 June 1997 were used. The Directorate for Veterinary Care, Drugs and Practice (Directorate-General for Veterinary Affairs, Ministry of Rural Development and Food) sent them directly to the educational establishments (universities and colleges of technology), research centres, healthcare institutions and businesses and pharmaceutical companies which use vertebrate animals for experimental and other scientific purposes. These documents were not sent to cosmetics manufacturers for the year in question, as our department was informed that no cosmetics company uses animals for experimental purposes in Greece.

The total number of animals used in experiments in Greece in 2011 was 28,001, of which:

95.21% (26,659 animals) were rodents (24,354 mice - 91.35%, 2,266 rats - 8.5%, 39 guinea pigs - 0.15%), of which 29.54% were used for basic biological research, 31.10% for research and development of medical, dental and veterinary products and appliances, 0.07% to control the production and quality of medical and dental products and appliances, 29.6% for toxicological and other safety studies, 7.77% for the diagnosis of disease, 0.76% for education and training purposes and, finally, 1.16% for other purposes.

2.5% (701 animals) were rabbits, of which 66.33% were used for basic biological research, 7.99% for the production and quality control of veterinary products and appliances, 14.27% for toxicological and other safety studies, 2.57% for the diagnosis of disease, 7.13% for education and training purposes and, finally, 1.71% for other purposes. 

1.39% (390 animals) were pigs, of which 58.72% were used for basic biological research, 1.03% for research and development of medical, dental and veterinary products and appliances, 3.08% for toxicological and other safety studies, 1.03% for the diagnosis of disease, 34.62% for education and training purposes and 1.54% for other purposes.

· 0.79% were amphibians (220 animals), which were used for education and training purposes. 

· 0.07% were cats (19 animals), which were used for basic biological studies.

· 0.03% were sheep (8 animals), which were all used for the diagnosis of disease.

· 0.01% were dogs (4 animals), which were all used for basic biological research.

The above data and the tables that have already been sent to you show that the three categories of experiment for which animals were most used in Greece in 2011 were biological research, followed by research and development of medical, dental and veterinary products and appliances and, lastly, toxicological and other safety studies.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 24354 || 24284 || || || 70 ||

1.b. || Rats (Rattus norvegicus) || 2266 || 2251 || || || 15 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 39 || || || || 39 ||

1.d. || Hamsters (Mesocricetus ) || || || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 701 || 683 || || || 18 ||

1.g. || Cats (Felis catus) || 19 || 19 || || || ||

1.h. || Dogs (Canis familiaris) || 4 || 4 || || || ||

1.i. || Ferrets (Mustela putorius furo) || || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || 390 || || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || 8 || || || || ||

1.o. || Cattle (Bos) || || || || || ||

1.p. || Prosimians (Prosimia) || || || || || ||

1.q. || New World Monkeys (Ceboidea) || || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || || || || || ||

1.s. || Apes (Hominoidea) || || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || || || || || ||

1.v. || Other birds (other Aves) || || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || 220 || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 28001 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 TABLE 2:    NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 5965 || 8291 || || || 7822 || 2033 || 117 || 126 || 24354

2.b. || Rats || 1910 || || 19 || || 70 || || 85 || 182 || 2266

2.c. || Guinea-Pigs || || || || || || 39 || || || 39

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || 465 || || || 56 || 100 || 18 || 50 || 12 || 701

2.g. || Cats || 19 || || || || || || || || 19

2.h. || Dogs || 4 || || || || || || || || 4

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || 229 || 4 || || || 12 || 4 || 135 || 6 || 390

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || || || || || || 8 || || || 8

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || || || || 0

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || 220 || || 220

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 8592 || 8295 || 19 || 56 || 8004 || 2102 || 607 || 326 || 28001

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || || || || || || || || || 7822 || 7822

3.b. || Rats || 70 || || || || || || || || || 70

3.c. || Guinea-Pigs || || || || || || || || || || 0

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 100 || || || || || || || || || 100

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || || || || || || || || || || 0

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || 12 || || || || || || || || || 12

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 182 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 7822 || 8004

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || || 5638 || 2530 || 1516 || 20 || 9704

4.b. || Rats || 246 || 120 || 160 || 107 || || 633

4.c. || Guinea-Pigs || || || || || 39 || 39

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || 5 || || || 17 || 18 || 40

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || 7 || || || 4 || 10 || 21

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || 8 || 8

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || || 0

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 258 || 5758 || 2690 || 1644 || 95 || 10445

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || || || 0 ||

5.b. || Rats || || 19 || || || || || 19 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || 56 || || || || || 56 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 0 || 75 || 0 || 0 || 0 || 0 || 75 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || || || || 7822 || || 7822 ||

6.b. || Rats || 70 || || || || || || 70 ||

6.c. || Guinea-Pigs || || || || || || || 0 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || 100 || || || || || || 100 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || || || 0 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || 12 || || || || || || 12 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || || || || || || 0 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || || 0 ||

6.y. || Fish || || || || || || || 0 ||

6.z. || TOTAL || 182 || 0 || 0 || 0 || 7822 || 0 || 8004 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || 7822 || || || || || || || || || || || || 7822

7.b. || Rats || || || || || || || || || || || || || 70 || 70

7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || || || || 40 || || || || || || || 60 || 100

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || || || || || || || || || || || || 0

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || 12 || 12

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || || || || || || || || 0

7.z. || TOTAL || 0 || 7822 || 0 || 0 || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 142 || 8004

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || || || || 40 || || || || || || || 142 || 182

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || || 7822 || || || || || || || || || || || || 7822

8.j. || TOTAL || 0 || 7822 || 0 || 0 || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 142 || 8004

SPAIN

Statistical data submitted

The Statistical data were provided by the Ministry for Agriculture, Food and the Environment, Directorate-General for Agriculture, Food and the Environment, Sub Directorate-General for Livestock Products.

Comments of Spanish authorities

The 2011 statistical report on the use of animals for experimental purposes was drawn up by the Ministry for Agriculture, Food and the Environment using data submitted by the Autonomous Communities which, in turn, received data from users registered in their respective territories.

In comparison with the previous report that was submitted in 2009, there was no significant variation in the total number of animals used. There were, however, a number of changes affecting the distribution of the data, reflecting current trends in the type of animals and their uses. There was:

· An increase in the use of mice but a drop in the use of rats;

· A drop in the use of primates with the focus on their use in safety tests (tests of chronic and sub-chronic toxicity);

· An increase in animals coming from 'other sources', which have tripled in number, the increase in mice being especially significant. Most of these come from the United States and – in much fewer numbers – from Japan, Canada and Australia. For the most part these are genetically modified animals;

· An increase in their use in studies of fundamental biology and of human and animal diseases, and for quality production and control; and

· A drop in their use in safety studies (essentially toxicology).

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 634912 || 519577 || 88532 || 798 || 26005 || 0

1.b. || Rats (Rattus norvegicus) || 126406 || 105889 || 18579 || 157 || 1781 || 0

1.c. || Guinea-Pigs (Cavia porcellus) || 13749 || 10116 || 3633 || 0 || 0 || 0

1.d. || Hamsters (Mesocricetus ) || 1492 || 1255 || 225 || 0 || 12 || 0

1.e. || Other Rodents (other Rodentia) || 80 || 0 || 0 || 0 || 0 || 0

1.f. || Rabbits (Oryctolagus cuniculus) || 21302 || 19614 || 1181 || 0 || 507 || 0

1.g. || Cats (Felis catus) || 229 || 108 || 0 || 0 || 121 || 0

1.h. || Dogs (Canis familiaris) || 1252 || 1112 || 95 || 0 || 45 || 0

1.i. || Ferrets (Mustela putorius furo) || 87 || 87 || 0 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 245 || 0 || 0 || 0 || 0 || 0

1.k. || Horses, donkeys and cross breds (Equidae) || 346 || 0 || 0 || 0 || 0 || 0

1.l. || Pigs (Sus) || 11046 || 69 || 4 || 0 || 0 || 0

1.m. || Goats (Capra) || 455 || 0 || 0 || 0 || 0 || 0

1.n. || Sheep (Ovis) || 2790 || 10 || 0 || 0 || 0 || 0

1.o. || Cattle (Bos) || 1464 || 0 || 0 || 0 || 0 || 0

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 1 || 1 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 342 || 288 || 54 || 0 || 0 || 0

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 56 || 0 || 0 || 0 || 0 || 0

1.u. || Quail (Coturnix coturnix) || 105 || 45 || 0 || 0 || 60 || 0

1.v. || Other birds (other Aves) || 21341 || 4 || 0 || 0 || 0 || 0

1.w. || Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0

1.x. || Amphibians (Amphibia) || 1097 || 0 || 0 || 0 || 0 || 0

1.y. || Fish (Pisces) || 61330 || 1535 || 0 || 0 || 0 || 0

1.z. || TOTAL || 900127 || 659710 || 112303 || 955 || 28531 || 0

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 370944 || 103633 || 24773 || 27598 || 49146 || 36806 || 5623 || 16389 || 634912

2.b. || Rats || 54843 || 34986 || 81 || 6597 || 5726 || 10841 || 6678 || 6654 || 126406

2.c. || Guinea-Pigs || 164 || 4213 || 4537 || 3376 || 1346 || 54 || 55 || 4 || 13749

2.d. || Hamsters || 606 || 348 || 0 || 0 || 128 || 408 || 2 || 0 || 1492

2.e. || Other Rodents || 15 || 0 || 0 || 0 || 0 || 0 || 25 || 40 || 80

2.f. || Rabbits || 1447 || 2612 || 6381 || 7613 || 1405 || 1235 || 267 || 342 || 21302

2.g. || Cats || 44 || 36 || 2 || 26 || 0 || 0 || 0 || 121 || 229

2.h. || Dogs || 50 || 691 || 0 || 192 || 157 || 4 || 88 || 70 || 1252

2.i. || Ferrets || 50 || 37 || 0 || 0 || 0 || 0 || 0 || 0 || 87

2.j. || Other Carnivores || 245 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 245

2.k. || Horses, donkeys and cross breds || 10 || 36 || 27 || 4 || 60 || 202 || 7 || 0 || 346

2.l. || Pigs || 407 || 4145 || 43 || 628 || 251 || 521 || 2080 || 2971 || 11046

2.m. || Goats || 43 || 55 || 51 || 2 || 0 || 0 || 137 || 167 || 455

2.n. || Sheep || 413 || 427 || 0 || 614 || 387 || 144 || 713 || 92 || 2790

2.o. || Cattle || 72 || 366 || 0 || 36 || 322 || 185 || 3 || 480 || 1464

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1

2.r. || Old World Monkeys || 7 || 73 || 0 || 0 || 252 || 0 || 10 || 0 || 342

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 0 || 0 || 0 || 56 || 0 || 0 || 0 || 0 || 56

2.u. || Quail || 0 || 0 || 0 || 0 || 45 || 0 || 0 || 60 || 105

2.v. || Other birds || 875 || 3930 || 321 || 11482 || 2835 || 1250 || 131 || 517 || 21341

2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.x. || Amphibians || 1097 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1097

2.y. || Fish || 36936 || 6291 || 0 || 0 || 7195 || 2365 || 146 || 8397 || 61330

2.z. || TOTAL || 468269 || 161879 || 36216 || 58224 || 69255 || 54015 || 15965 || 36304 || 900127

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 12996 || 0 || 0 || 0 || 0 || 0 || 796 || 621 || 34733 || 49146

3.b. || Rats || 5420 || 18 || 115 || 0 || 0 || 0 || 16 || 0 || 157 || 5726

3.c. || Guinea-Pigs || 1346 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1346

3.d. || Hamsters || 128 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 128

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 1218 || 0 || 131 || 47 || 0 || 0 || 9 || 0 || 0 || 1405

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 157 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 157

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 60 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 60

3.l. || Pigs || 235 || 0 || 0 || 0 || 0 || 0 || 16 || 0 || 0 || 251

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 387 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 387

3.o. || Cattle || 322 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 322

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 252 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 252

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 45

3.v. || Other birds || 333 || 0 || 0 || 0 || 0 || 0 || 2502 || 0 || 0 || 2835

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 4000 || 0 || 0 || 0 || 0 || 276 || 0 || 456 || 2463 || 7195

3.z. || TOTAL || 26854 || 63 || 246 || 47 || 0 || 276 || 3339 || 1077 || 37353 || 69255

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 35673 || 85766 || 141240 || 121534 || 16315 || 400528

4.b. || Rats || 6520 || 27751 || 1430 || 47935 || 574 || 84210

4.c. || Guinea-Pigs || 0 || 12 || 0 || 4208 || 122 || 4342

4.d. || Hamsters || 20 || 241 || 400 || 270 || 286 || 1217

4.e. || Other Rodents || 0 || 285 || 0 || 14 || 0 || 299

4.f. || Rabbits || 125 || 69 || 6 || 2648 || 1798 || 4646

4.g. || Cats || 2 || 12 || 0 || 0 || 26 || 40

4.h. || Dogs || 0 || 0 || 3 || 287 || 284 || 574

4.i. || Ferrets || 0 || 36 || 0 || 51 || 0 || 87

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 60 || 60

4.l. || Pigs || 776 || 100 || 32 || 771 || 2452 || 4131

4.m. || Goats || 0 || 0 || 0 || 33 || 30 || 63

4.n. || Sheep || 22 || 0 || 0 || 147 || 365 || 534

4.o. || Cattle || 0 || 0 || 0 || 0 || 383 || 383

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 1 || 0 || 0 || 0 || 1

4.r. || Old World Monkeys || 4 || 40 || 2 || 281 || 0 || 327

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 56 || 56

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 0 || 0 || 5202 || 5202

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 46 || 100 || 409 || 0 || 555

4.y. || Fish || 2306 || 608 || 9603 || 10278 || 5979 || 28774

4.z. || TOTAL || 45448 || 114967 || 152816 || 188866 || 33932 || 536029

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 0 || 37024 || 0 || 0 || 8459 || 6888 || 52371 ||

5.b. || Rats || 0 || 6678 || 0 || 0 || 0 || 0 || 6678 ||

5.c. || Guinea-Pigs || 0 || 3524 || 0 || 984 || 3363 || 42 || 7913 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 0 || 8021 || 13 || 0 || 5901 || 59 || 13994 ||

5.g. || Cats || 0 || 28 || 0 || 0 || 0 || 0 || 28 ||

5.h. || Dogs || 0 || 192 || 0 || 0 || 0 || 0 || 192 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 31 || 0 || 0 || 0 || 0 || 31 ||

5.l. || Pigs || 0 || 591 || 15 || 0 || 0 || 65 || 671 ||

5.m. || Goats || 0 || 51 || 0 || 0 || 0 || 2 || 53 ||

5.n. || Sheep || 30 || 532 || 0 || 0 || 0 || 52 || 614 ||

5.o. || Cattle || 10 || 15 || 0 || 0 || 0 || 11 || 36 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 56 || 0 || 56 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 1144 || 10580 || 0 || 0 || 79 || 0 || 11803 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.z. || TOTAL || 1184 || 67267 || 28 || 984 || 17858 || 7119 || 94440 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 2040 || 18978 || 75 || 465 || 25054 || 2534 || 49146 ||

6.b. || Rats || 931 || 1039 || 0 || 61 || 2771 || 924 || 5726 ||

6.c. || Guinea-Pigs || 0 || 787 || 0 || 168 || 0 || 391 || 1346 ||

6.d. || Hamsters || 128 || 0 || 0 || 0 || 0 || 0 || 128 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 0 || 1062 || 0 || 102 || 230 || 11 || 1405 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 0 || 0 || 0 || 0 || 157 || 0 || 157 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 60 || 0 || 0 || 0 || 0 || 0 || 60 ||

6.l. || Pigs || 22 || 183 || 0 || 0 || 46 || 0 || 251 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 299 || 20 || 0 || 0 || 68 || 0 || 387 ||

6.o. || Cattle || 230 || 38 || 0 || 0 || 54 || 0 || 322 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 252 || 0 || 252 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 45 || 0 || 0 || 0 || 0 || 0 || 45 ||

6.v. || Other birds || 0 || 2735 || 0 || 0 || 100 || 0 || 2835 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 456 || 4000 || 0 || 0 || 2463 || 276 || 7195 ||

6.z. || TOTAL || 4211 || 28842 || 75 || 796 || 31195 || 4136 || 69255 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 5380 || 25942 || 8962 || 0 || 0 || 0 || 5000 || 0 || 0 || 0 || 0 || 0 || 3862 || 49146

7.b. || Rats || 68 || 323 || 234 || 0 || 32 || 0 || 2724 || 0 || 390 || 0 || 294 || 0 || 1661 || 5726

7.c. || Guinea-Pigs || 0 || 389 || 0 || 0 || 562 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 395 || 1346

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 128 || 0 || 0 || 0 || 0 || 0 || 0 || 128

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 0 || 261 || 26 || 84 || 263 || 0 || 169 || 0 || 33 || 0 || 569 || 1405

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 157 || 0 || 0 || 0 || 0 || 0 || 0 || 157

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 60 || 0 || 0 || 0 || 0 || 60

7.l. || Pigs || 0 || 0 || 0 || 6 || 0 || 0 || 0 || 0 || 22 || 0 || 0 || 0 || 223 || 251

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 299 || 0 || 0 || 0 || 88 || 387

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 230 || 0 || 0 || 0 || 92 || 322

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 252 || 0 || 0 || 0 || 0 || 0 || 0 || 252

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 45

7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2835 || 2835

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 732 || 0 || 3500 || 0 || 0 || 0 || 2963 || 7195

7.z. || TOTAL || 5448 || 26654 || 9196 || 267 || 620 || 84 || 9301 || 0 || 4670 || 0 || 327 || 0 || 12688 || 69255

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 1100 || 3659 || 394 || 167 || 620 || 6 || 8279 || 0 || 4670 || 0 || 327 || 0 || 7632 || 26854

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 0 || 0 || 0 || 0 || 63 || 0 || 0 || 0 || 0 || 0 || 0 || 63

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 53 || 0 || 78 || 115 || 0 || 0 || 0 || 0 || 0 || 0 || 246

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 47 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 47

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 276 || 0 || 0 || 0 || 0 || 0 || 0 || 276

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 53 || 768 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2518 || 3339

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 546 || 0 || 0 || 0 || 0 || 0 || 456 || 0 || 0 || 0 || 0 || 0 || 75 || 1077

8.i. || Other toxicological or safety evaluations || 3749 || 22227 || 8802 || 0 || 0 || 0 || 112 || 0 || 0 || 0 || 0 || 0 || 2463 || 37353

8.j. || TOTAL || 5448 || 26654 || 9196 || 267 || 620 || 84 || 9301 || 0 || 4670 || 0 || 327 || 0 || 12688 || 69255

[1] N.B. Two corrections were identified after the data submission: 1) The 39 goats should be corrected to 13 goats. The detailed information in Table 4 should be corrected from 26 goats in Column 4.5 and 13 goats in Column 4.6 to zero goats in Column 4.5 and 13 goats in Column 4.6; 2) 2 pigs listed in Column 4.6 should be moved to Column 4.5.

COMMISSION STAFF WORKING DOCUMENT

Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

PART B III: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

TABLE OF CONTENTS

FRANCE.................................................................................................................................... 6

ITALY...................................................................................................................................... 15

CYPRUS.................................................................................................................................. 24

LATVIA................................................................................................................................... 29

LITHUANIA............................................................................................................................ 35

LUXEMBOURG..................................................................................................................... 44

HUNGARY.............................................................................................................................. 48

MALTA.................................................................................................................................... 57

THE NETHERLANDS............................................................................................................ 60

FRANCE

Statistical data submitted

The statistical data were submitted by the 'Ministère de l’Enseignement Supérieur et de la Recherche' (Ministry for Higher Education and Research).

Comments of the French authorities

This study was realized by the IsoCL Company (formerly Eficom Marketudes) for the Research and Higher Education Ministry.

In France, 2.2 million animals were used for scientific purposes in 2010, whereas 2.3 million were used in 2007. It appears that the number of animals used showed a steady state since 1999 with about 2.2 million. It represents a decrease of 40% in comparison with the figures of the first statistical study in 1990.

1,326,274 of the animals used were mice (60%). Fish accounted for 354,039 (16%) of the animals used, rats for 252,589 (11%), and rabbits for 125,913 (6%).

Cool-blooded animals (fish, amphibian and reptiles) accounted for 357,392 (16%) of the animals used.

Non-human primates accounted for 1,810 animals, 0.08% of the animals used, a reduction of 34% compared with 2007. Most of the non-human primates used were cercopithecoidea (86%) and more precisely Macaca cynomolgus (70%). Similarly to previous years, no apes were used for scientific purposes.

Since 2007, rodents (1,622,840) showed a reduction of 20%, whereas rabbits (125,913) and fish (354,039) presented an increase of 31% and 1650%, respectively.

Concerning the purpose, 1,103,214 animals (50%) were used for research purposes: 598,532 animals (27%) were used for fundamental biology studies and 504,682 (23%) were used for research and development and production and quality control relating to human medicine, dentistry and veterinary medicine. 403,426 animals (18%) were used for production and quality control of products and devices for human medicine and dentistry.

Toxicological or other safety evaluations used 78,041 animals (3.5%).

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 1 326 274 || 1 193 758 || 20 682 || 39 110 || 72 724 || 914

1.b. || Rats (Rattus norvegicus) || 252 589 || 244 910 || 674 || 1 030 || 5 975 || 2 132

1.c. || Guinea-Pigs (Cavia porcellus) || 35 543 || 31 181 || 3 857 || 410 || 95 || 0

1.d. || Hamsters (Mesocricetus ) || 8 210 || 6 805 || 243 || 0 || 1 162 || 0

1.e. || Other Rodents (other Rodentia) || 224 || 0 || 0 || 0 || 0 || 0

1.f. || Rabbits (Oryctolagus cuniculus) || 125 913 || 125 912 || 0 || 1 || 0 || 1 102

1.g. || Cats (Felis catus) || 569 || 479 || 69 || 0 || 21 || 130

1.h. || Dogs (Canis familiaris) || 3 032 || 1 840 || 373 || 129 || 690 || 825

1.i. || Ferrets (Mustela putorius furo) || 351 || 0 || 0 || 0 || 351 || 72

1.j. || Other Carnivores (other Carnivora) || 0 || 0 || 0 || 0 || 0 || 0

1.k. || Horses, donkeys and cross breds (Equidae) || 373 || 0 || 0 || 0 || 0 || 0

1.l. || Pigs (Sus) || 7 364 || 0 || 0 || 0 || 0 || 0

1.m. || Goats (Capra) || 710 || 0 || 0 || 0 || 0 || 0

1.n. || Sheep (Ovis) || 5 491 || 0 || 0 || 0 || 0 || 0

1.o. || Cattle (Bos) || 2 362 || 0 || 0 || 0 || 0 || 0

1.p. || Prosimians (Prosimia) || 83 || 83 || 0 || 0 || 0 || 83

1.q. || New World Monkeys (Ceboidea) || 163 || 160 || 3 || 0 || 0 || 156

1.r. || Old World Monkeys (Cercopithecoidea) || 1 564 || 666 || 63 || 0 || 835 || 514

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 2 || 0 || 0 || 0 || 0 || 0

1.u. || Quail (Coturnix coturnix) || 122 || 122 || 0 || 0 || 0 || 0

1.v. || Other birds (other Aves) || 71 821 || 0 || 0 || 0 || 0 || 0

1.w. || Reptiles (Reptilia) || 74 || 0 || 0 || 0 || 0 || 0

1.x. || Amphibians (Amphibia) || 3 279 || 0 || 0 || 0 || 0 || 0

1.y. || Fish (Pisces) || 354 039 || || || || ||

1.z. || TOTAL || 2 200 152 || 1 605 916 || 25 964 || 40 680 || 81 853 || 5 928

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 547 843 || 347 485 || 312 483 || 13 527 || 22 074 || 2 879 || 10 722 || 69 261 || 1 326 274

2.b. || Rats || 45 681 || 130 052 || 3 638 || 163 || 41 799 || 152 || 10 105 || 20 999 || 252 589

2.c. || Guinea-Pigs || 464 || 4 816 || 25 829 || 750 || 2 609 || 0 || 75 || 1 000 || 35 543

2.d. || Hamsters || 567 || 3 361 || 0 || 1 416 || 542 || 0 || 80 || 2 244 || 8 210

2.e. || Other Rodents || 118 || 100 || 0 || 0 || 0 || 0 || 6 || 0 || 224

2.f. || Rabbits || 1 343 || 6 922 || 53 613 || 1 015 || 3 733 || 8 || 424 || 58 855 || 125 913

2.g. || Cats || 40 || 317 || 0 || 132 || 68 || 0 || 0 || 12 || 569

2.h. || Dogs || 125 || 1 012 || 0 || 375 || 1 483 || 0 || 6 || 31 || 3 032

2.i. || Ferrets || 36 || 288 || 4 || 0 || 20 || 0 || 3 || 0 || 351

2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.k. || Horses, donkeys and cross breds || 3 || 96 || 94 || 5 || 0 || 0 || 10 || 165 || 373

2.l. || Pigs || 136 || 1 759 || 0 || 681 || 245 || 4 || 1 951 || 2 588 || 7 364

2.m. || Goats || 78 || 35 || 0 || 0 || 0 || 7 || 0 || 590 || 710

2.n. || Sheep || 18 || 510 || 10 || 808 || 161 || 0 || 5 || 3 979 || 5 491

2.o. || Cattle || 3 || 443 || 0 || 108 || 239 || 0 || 19 || 1 550 || 2 362

2.p. || Prosimians || 83 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 83

2.q. || New World Monkeys || 31 || 125 || 0 || 0 || 6 || 0 || 0 || 1 || 163

2.r. || Old World Monkeys || 110 || 484 || 86 || 0 || 811 || 0 || 0 || 73 || 1 564

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2

2.u. || Quail || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 122

2.v. || Other birds || 294 || 3 818 || 7 669 || 38 277 || 45 || 0 || 58 || 21 660 || 71 821

2.w. || Reptiles || 74 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 74

2.x. || Amphibians || 1 016 || 12 || 0 || 0 || 0 || 0 || 2 238 || 13 || 3 279

2.y. || Fish || 345 || 3 047 || 0 || 0 || 4 206 || 0 || 418 || 346 023 || 354 039

2.z. || TOTAL || 598 532 || 504 682 || 403 426 || 57 257 || 78 041 || 3 050 || 26 120 || 529 044 || 2 200 152

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 9 604 || 3 122 || 1 765 || 0 || 0 || 52 || 0 || 872 || 6 659 || 22 074

3.b. || Rats || 15 019 || 5 979 || 4 235 || 0 || 40 || 70 || 54 || 756 || 15 646 || 41 799

3.c. || Guinea-Pigs || 914 || 750 || 150 || 0 || 0 || 0 || 0 || 0 || 795 || 2 609

3.d. || Hamsters || 254 || 73 || 21 || 0 || 0 || 0 || 0 || 0 || 194 || 542

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 1 043 || 397 || 212 || 0 || 0 || 0 || 0 || 0 || 2 081 || 3 733

3.g. || Cats || 68 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 68

3.h. || Dogs || 693 || 88 || 0 || 0 || 0 || 0 || 0 || 0 || 702 || 1 483

3.i. || Ferrets || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.l. || Pigs || 112 || 0 || 0 || 0 || 0 || 0 || 0 || 3 || 130 || 245

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 21 || 140 || 0 || 161

3.o. || Cattle || 233 || 0 || 0 || 0 || 0 || 0 || 6 || 0 || 0 || 239

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 6

3.r. || Old World Monkeys || 242 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 569 || 811

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.v. || Other birds || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 45

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 86 || 2 049 || 0 || 0 || 0 || 0 || 0 || 0 || 2 071 || 4 206

3.z. || TOTAL || 28 333 || 12 458 || 6 383 || 0 || 40 || 122 || 81 || 1 771 || 28 853 || 78 041

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 94 767 || 142 675 || 178 443 || 261 176 || 221 146 || 898 207

4.b. || Rats || 38 018 || 78 662 || 4 392 || 53 274 || 1 539 || 175 885

4.c. || Guinea-Pigs || 652 || 281 || 26 || 4 028 || 293 || 5 280

4.d. || Hamsters || 506 || 0 || 72 || 1 109 || 2 241 || 3 928

4.e. || Other Rodents || 0 || 0 || 0 || 80 || 138 || 218

4.f. || Rabbits || 1 438 || 184 || 79 || 6 483 || 89 || 8 273

4.g. || Cats || 0 || 19 || 0 || 44 || 294 || 357

4.h. || Dogs || 68 || 41 || 1 || 286 || 741 || 1 137

4.i. || Ferrets || 0 || 0 || 0 || 273 || 51 || 324

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 99 || 99

4.l. || Pigs || 544 || 29 || 0 || 549 || 777 || 1 899

4.m. || Goats || 0 || 0 || 0 || 31 || 89 || 120

4.n. || Sheep || 170 || 0 || 0 || 69 || 289 || 528

4.o. || Cattle || 4 || 0 || 0 || 3 || 439 || 446

4.p. || Prosimians || 0 || 58 || 0 || 25 || 0 || 83

4.q. || New World Monkeys || 0 || 0 || 0 || 156 || 0 || 156

4.r. || Old World Monkeys || 343 || 12 || 0 || 194 || 45 || 594

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 2 || 0 || 0 || 2

4.u. || Quail || 0 || 0 || 0 || 122 || 0 || 122

4.v. || Other birds || 0 || 0 || 0 || 299 || 3 813 || 4 112

4.w. || Reptiles || 0 || 0 || 0 || 24 || 50 || 74

4.x. || Amphibians || 36 || 40 || 0 || 67 || 885 || 1 028

4.y. || Fish || 0 || 0 || 0 || 3 127 || 265 || 3 392

4.z. || TOTAL || 136 546 || 222 001 || 183 015 || 331 419 || 233 283 || 1 106 264

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 24 926 || 49 841 || 2 162 || 0 || 223 452 || 25 629 || 326 010 ||

5.b. || Rats || 3 282 || 243 || 0 || 0 || 274 || 2 || 3 801 ||

5.c. || Guinea-Pigs || 0 || 3 064 || 0 || 280 || 23 235 || 0 || 26 579 ||

5.d. || Hamsters || 0 || 1 416 || 0 || 0 || 0 || 0 || 1 416 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 488 || 27 006 || 0 || 0 || 2 338 || 24 796 || 54 628 ||

5.g. || Cats || 0 || 132 || 0 || 0 || 0 || 0 || 132 ||

5.h. || Dogs || 118 || 257 || 0 || 0 || 0 || 0 || 375 ||

5.i. || Ferrets || 0 || 0 || 0 || , || 4 || 0 || 4 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 99 || 0 || 0 || 0 || 0 || 99 ||

5.l. || Pigs || 0 || 681 || 0 || 0 || 0 || 0 || 681 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 818 || 0 || 0 || 0 || 0 || 818 ||

5.o. || Cattle || 0 || 108 || 0 || 0 || 0 || 0 || 108 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 86 || 0 || 86 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 0 || 45 916 || 0 || 0 || 0 || 30 || 45 946 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.z. || TOTAL || 28 814 || 129 581 || 2 162 || 280 || 249 389 || 50 457 || 460 683 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 7 193 || 3 680 || 0 || 4 092 || 5 029 || 2 080 || 22 074 ||

6.b. || Rats || 10 268 || 3 372 || 162 || 9 058 || 16 064 || 2 875 || 41 799 ||

6.c. || Guinea-Pigs || 610 || 954 || 0 || 745 || 163 || 137 || 2 609 ||

6.d. || Hamsters || 21 || 62 || 0 || 174 || 285 || 0 || 542 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 873 || 684 || 250 || 1 336 || 469 || 121 || 3 733 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 68 || 0 || 68 ||

6.h. || Dogs || 270 || 28 || 0 || 428 || 757 || 0 || 1 483 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 20 || 0 || 20 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.l. || Pigs || 0 || 0 || 0 || 120 || 125 || 0 || 245 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 21 || 0 || 0 || 0 || 0 || 140 || 161 ||

6.o. || Cattle || 6 || 8 || 0 || 0 || 225 || 0 || 239 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 6 || 0 || 6 ||

6.r. || Old World Monkeys || 170 || 0 || 0 || 348 || 270 || 23 || 811 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.v. || Other birds || 0 || 0 || 0 || 0 || 45 || 0 || 45 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 0 || 0 || 0 || 2 071 || 2 049 || 86 || 4 206 ||

6.z. || TOTAL || 19 432 || 8 788 || 412 || 18 372 || 25 575 || 5 462 || 78 041 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 364 || 1 593 || 2 575 || 28 || 2 307 || 0 || 5 996 || 2 226 || 702 || 220 || 0 || 0 || 6 063 || 22 074

7.b. || Rats || 102 || 2 195 || 2 652 || 0 || 0 || 0 || 10 494 || 1 273 || 2 579 || 1 633 || 1 089 || 0 || 19 782 || 41 799

7.c. || Guinea-Pigs || 0 || 13 || 0 || 0 || 1 130 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 466 || 2 609

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 265 || 0 || 0 || 0 || 0 || 0 || 277 || 542

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 260 || 348 || 0 || 295 || 16 || 0 || 424 || 0 || 0 || 0 || 2 390 || 3 733

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 68 || 68

7.h. || Dogs || 0 || 0 || 78 || 0 || 0 || 0 || 563 || 0 || 0 || 0 || 0 || 0 || 842 || 1 483

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20 || 20

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.l. || Pigs || 0 || 0 || 15 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 230 || 245

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 161 || 161

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 239 || 239

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 6

7.r. || Old World Monkeys || 0 || 0 || 31 || 0 || 0 || 0 || 216 || 0 || 0 || 0 || 0 || 0 || 564 || 811

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 45 || 45

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 0 || 0 || 86 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 049 || 2 071 || 4 206

7.z. || TOTAL || 466 || 3 801 || 5 697 || 376 || 3 437 || 295 || 17 550 || 3 499 || 3 705 || 1 853 || 1 089 || 2 049 || 34 224 || 78 041

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 226 || 1 053 || 5 657 || 85 || 864 || 40 || 8 426 || 1 701 || 1 120 || 1 330 || 447 || 0 || 7 384 || 28 333

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 1 596 || 0 || 160 || 750 || 144 || 5 085 || 1 798 || 664 || 70 || 142 || 2 049 || 0 || 12 458

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 211 || 0 || 116 || 1 823 || 96 || 0 || 0 || 840 || 371 || 0 || 0 || 2 926 || 6 383

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 40

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 70 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 52 || 122

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 54 || 0 || 0 || 27 || 81

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 153 || 0 || 0 || 0 || 0 || 1 267 || 0 || 0 || 28 || 0 || 0 || 323 || 1 771

8.i. || Other toxicological or safety evaluations || 240 || 718 || 0 || 15 || 0 || 15 || 2 772 || 0 || 1 081 || 0 || 500 || 0 || 23 512 || 28 853

8.j. || TOTAL || 466 || 3 801 || 5 697 || 376 || 3 437 || 295 || 17 550 || 3 499 || 3 705 || 1 853 || 1 089 || 2 049 || 34 224 || 78 041

ITALY

Statistical data submitted

The statistical data were submitted by Ministry of Health, Directorate General for Animal Health and Veterinary Medicinal Products, Office VI, Animal Welfare.

Comments of the Italian authorities

The data collected have been used for the ‘EU harmonised statistical tables’ produced by the competent national EU authorities for 1997.

In general the trend of an overall decrease in the numbers of the animals used for experiments has been confirmed and from 1999 the numbers have been consistently under 1 million animals.

This said, there has been a significant increase in percentage terms in the use of mice (+ 2.01) and fish (+ 5.01) with regard to 2008.

The tables also show data on the animals used for in vitro studies (euthanized to remove organs, tissues and cells).

88.99 %        of the species of animals used were rodents or rabbits.

53.78 %        of animals were used in basic biological studies.

33.87 %        of animals were used for research and development, for the production and quality control of products and appliances for human medicine, orthodontics and veterinary medicine.

7.82 %          of animals were used in toxicological studies.

4.53 %          of animals were used to diagnose illnesses, for teaching and other purposes.

In general a decrease has been noted in the number of animals used for the production and quality control of products and appliances for human medicine, orthodontics and veterinary medicine and for toxicological studies (- 4.22% with regard to 2008).

Article 24 of Directive 86/609/EEC, which was transposed into Italian law with Legislative Decree No 116/92, has allowed the introduction of stricter measures which concern, in particular, the use of non-human primates, dogs and cats as stipulated in Article 3(2) of the above-mentioned Legislative Decree: 'as regards non-human primates, dogs and cats, the authorisation referred to in Article 8(1)(b) is also required.'

However the use of non-human primates, dogs and cats is permitted only after obtaining specific prior authorisation from the Ministry of Health.

All this has resulted in non-human primates, dogs and cats accounting overall for 0.11% of the total animals used.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || || 515946 || 486030 || 13639 || 117 || 16160

1.b. || Rats (Rattus norvegicus) || || 155136 || 153134 || 1067 || 0 || 935

1.c. || Guinea-Pigs (Cavia porcellus) || || 13784 || 11155 || 2629 || 0 || 0

1.d. || Hamsters (Mesocricetus ) || || 517 || 517 || 0 || 0 || 0

1.e. || Other Rodents (other Rodentia) || || 1946 || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || || 8392 || 7847 || 545 || 0 || 0

1.g. || Cats (Felis catus) || || 0 || 0 || 0 || 0 || 0

1.h. || Dogs (Canis familiaris) || || 408 || 214 || 154 || 0 || 40

1.i. || Ferrets (Mustela putorius furo) || || 0 || 0 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || || 0 || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || 34 || || || ||

1.l. || Pigs (Sus) || || 2486 || || || ||

1.m. || Goats (Capra) || || 34 || || || ||

1.n. || Sheep (Ovis) || || 243 || || || ||

1.o. || Cattle (Bos) || || 27 || || || ||

1.p. || Prosimians (Prosimia) || || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || || 79 || 68 || 11 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || || 371 || 40 || 291 || 2 || 38

1.s. || Apes (Hominoidea) || || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || || 184 || || || ||

1.u. || Quail (Coturnix coturnix) || || 4 || 4 || 0 || 0 || 0

1.v. || Other birds (other Aves) || || 29305 || || || ||

1.w. || Reptiles (Reptilia) || || 239 || || || ||

1.x. || Amphibians (Amphibia) || || 894 || || || ||

1.y. || Fish (Pisces) || || 51786 || || || ||

1.z. || TOTAL || 864318 || 781815 || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 307552 || 112340 || 35049 || 1821 || 29226 || 25026 || 25 || 4907 || 515946

2.b. || Rats || 60920 || 23858 || 53323 || 880 || 14109 || 857 || 639 || 550 || 155136

2.c. || Guinea-Pigs || 1206 || 2812 || 2671 || 518 || 6531 || 21 || 0 || 25 || 13784

2.d. || Hamsters || 327 || 28 || 0 || 0 || 161 || 0 || 0 || 1 || 517

2.e. || Other Rodents || 92 || 493 || 0 || 0 || 0 || 1361 || 0 || 0 || 1946

2.f. || Rabbits || 556 || 398 || 4681 || 659 || 1918 || 161 || 0 || 19 || 8392

2.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.h. || Dogs || 0 || 49 || 0 || 0 || 359 || 0 || 0 || 0 || 408

2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.k. || Horses, donkeys and cross breds || 23 || 0 || 0 || 0 || 0 || 8 || 0 || 3 || 34

2.l. || Pigs || 319 || 350 || 7 || 840 || 453 || 1 || 473 || 43 || 2486

2.m. || Goats || 3 || 3 || 0 || 0 || 0 || 28 || 0 || 0 || 34

2.n. || Sheep || 108 || 109 || 0 || 0 || 18 || 0 || 0 || 8 || 243

2.o. || Cattle || 5 || 0 || 0 || 20 || 2 || 0 || 0 || 0 || 27

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 68 || 0 || 0 || 11 || 0 || 0 || 0 || 79

2.r. || Old World Monkeys || 19 || 55 || 35 || 0 || 262 || 0 || 0 || 0 || 371

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 184 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 184

2.u. || Quail || 4 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 4

2.v. || Other birds || 3694 || 664 || 5 || 19778 || 4124 || 956 || 0 || 84 || 29305

2.w. || Reptiles || 238 || 0 || 0 || 0 || 0 || 0 || 0 || 1 || 239

2.x. || Amphibians || 894 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 894

2.y. || Fish || 44307 || 1660 || 0 || 1600 || 3986 || 0 || 0 || 233 || 51786

2.z. || TOTAL || 420451 || 142887 || 95771 || 26116 || 61160 || 28419 || 1137 || 5874 || 781815

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contaminants in the general environment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total

3.a. || Mice || 5390 || 0 || 90 || 0 || 0 || 0 || 160 || 0 || 23586 || 29226

3.b. || Rats || 10041 || 603 || 2228 || 0 || 0 || 311 || 0 || 0 || 926 || 14109

3.c. || Guinea-Pigs || 5992 || 468 || 0 || 0 || 0 || 0 || 0 || 0 || 71 || 6531

3.d. || Hamsters || 153 || 0 || 0 || 8 || 0 || 0 || 0 || 0 || 0 || 161

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 1812 || 69 || 21 || 0 || 0 || 0 || 0 || 4 || 12 || 1918

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 359 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 359

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.l. || Pigs || 309 || 0 || 0 || 0 || 0 || 0 || 144 || 0 || 0 || 453

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 18 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 18

3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 2

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11

3.r. || Old World Monkeys || 262 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 262

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.v. || Other birds || 3620 || 0 || 0 || 0 || 0 || 0 || 504 || 0 || 0 || 4124

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 310 || 0 || 1866 || 0 || 0 || 0 || 0 || 1810 || 0 || 3986

3.z. || TOTAL || 28277 || 1140 || 4205 || 8 || 0 || 311 || 808 || 1814 || 24597 || 61160

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 17852 || 53875 || 88910 || 124413 || 17426 || 302476

4.b. || Rats || 3670 || 27783 || 5572 || 18448 || 606 || 56079

4.c. || Guinea-Pigs || 58 || 376 || 0 || 3330 || 0 || 3764

4.d. || Hamsters || 28 || 90 || 0 || 158 || 0 || 276

4.e. || Other Rodents || 0 || 0 || 0 || 1197 || 749 || 1946

4.f. || Rabbits || 122 || 43 || 3 || 545 || 179 || 892

4.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0

4.h. || Dogs || 15 || 24 || 140 || 82 || 0 || 261

4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0

4.l. || Pigs || 73 || 0 || 9 || 165 || 1 || 248

4.m. || Goats || 0 || 0 || 0 || 0 || 31 || 31

4.n. || Sheep || 14 || 0 || 2 || 59 || 33 || 108

4.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 57 || 0 || 11 || 0 || 68

4.r. || Old World Monkeys || 4 || 10 || 42 || 50 || 0 || 106

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 5 || 5

4.u. || Quail || 0 || 0 || 0 || 0 || 4 || 4

4.v. || Other birds || 0 || 0 || 0 || 0 || 120 || 120

4.w. || Reptiles || 0 || 0 || 0 || 0 || 99 || 99

4.x. || Amphibians || 0 || 41 || 0 || 7 || 0 || 48

4.y. || Fish || 0 || 0 || 0 || 21151 || 120 || 21271

4.z. || TOTAL || 21836 || 82299 || 94678 || 169616 || 19373 || 387802

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 3477 || 13930 || 0 || 100 || 14863 || 4500 || 36870 ||

5.b. || Rats || 72 || 4662 || 0 || 0 || 49469 || 0 || 54203 ||

5.c. || Guinea-Pigs || 536 || 203 || 0 || 0 || 2450 || 0 || 3189 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 363 || 4063 || 0 || 0 || 914 || 0 || 5340 ||

5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.l. || Pigs || 121 || 692 || 0 || 0 || 34 || 0 || 847 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.o. || Cattle || 0 || 20 || 0 || 0 || 0 || 0 || 20 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 35 || 0 || 35 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 1249 || 18534 || 0 || 0 || 0 || 0 || 19783 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 1600 || 0 || 0 || 0 || 0 || 0 || 1600 ||

5.z. || TOTAL || 7418 || 42104 || 0 || 100 || 67765 || 4500 || 121887 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 21297 || 3702 || 10 || 0 || 4212 || 5 || 29226 ||

6.b. || Rats || 3640 || 7086 || 0 || 0 || 2961 || 422 || 14109 ||

6.c. || Guinea-Pigs || 93 || 4962 || 30 || 0 || 1444 || 2 || 6531 ||

6.d. || Hamsters || 0 || 150 || 0 || 0 || 11 || 0 || 161 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 136 || 1409 || 0 || 0 || 311 || 62 || 1918 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 227 || 132 || 0 || 0 || 0 || 0 || 359 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.l. || Pigs || 0 || 453 || 0 || 0 || 0 || 0 || 453 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 18 || 0 || 0 || 0 || 0 || 18 ||

6.o. || Cattle || 2 || 0 || 0 || 0 || 0 || 0 || 2 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 11 || 0 || 0 || 0 || 0 || 11 ||

6.r. || Old World Monkeys || 51 || 0 || 0 || 0 || 211 || 0 || 262 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.v. || Other birds || 0 || 4124 || 0 || 0 || 0 || 0 || 4124 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 240 || 3476 || 0 || 0 || 0 || 270 || 3986 ||

6.z. || TOTAL || 25686 || 25523 || 40 || 0 || 9150 || 761 || 61160 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino-genicity || 7.8 Develop-mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 320 || 5089 || 11864 || 0 || 0 || 0 || 733 || 0 || 0 || 182 || 36 || 0 || 11002 || 29226

7.b. || Rats || 24 || 405 || 5618 || 6 || 0 || 0 || 4390 || 0 || 493 || 92 || 2710 || 0 || 371 || 14109

7.c. || Guinea-Pigs || 0 || 5 || 116 || 0 || 6410 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6531

7.d. || Hamsters || 0 || 0 || 0 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 150 || 161

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 5 || 0 || 234 || 351 || 0 || 117 || 54 || 0 || 34 || 0 || 4 || 0 || 1119 || 1918

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 249 || 0 || 0 || 0 || 107 || 0 || 0 || 0 || 0 || 0 || 3 || 359

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.l. || Pigs || 0 || 0 || 187 || 3 || 0 || 0 || 80 || 0 || 0 || 0 || 0 || 0 || 183 || 453

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 18 || 18

7.o. || Cattle || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11

7.r. || Old World Monkeys || 0 || 0 || 99 || 0 || 0 || 0 || 145 || 0 || 0 || 0 || 0 || 0 || 18 || 262

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.v. || Other birds || 0 || 0 || 3365 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 759 || 4124

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 760 || 0 || 2136 || 0 || 0 || 0 || 1050 || 0 || 0 || 0 || 0 || 0 || 40 || 3986

7.z. || TOTAL || 1109 || 5499 || 23881 || 371 || 6410 || 117 || 6559 || 0 || 527 || 274 || 2750 || 0 || 13663 || 61160

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta-genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 329 || 402 || 12418 || 314 || 5942 || 78 || 5248 || 0 || 218 || 152 || 856 || 0 || 2320 || 28277

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 90 || 91 || 36 || 468 || 33 || 0 || 0 || 0 || 0 || 422 || 0 || 0 || 1140

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 82 || 2149 || 21 || 0 || 6 || 100 || 0 || 289 || 90 || 1468 || 0 || 0 || 4205

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8 || 8

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 36 || 25 || 0 || 0 || 0 || 0 || 0 || 0 || 32 || 0 || 0 || 218 || 311

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 160 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 648 || 808

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 760 || 0 || 0 || 0 || 0 || 0 || 1050 || 0 || 0 || 0 || 4 || 0 || 0 || 1814

8.i. || Other toxicological or safety evaluations || 20 || 4729 || 9198 || 0 || 0 || 0 || 161 || 0 || 20 || 0 || 0 || 0 || 10469 || 24597

8.j. || TOTAL || 1109 || 5499 || 23881 || 371 || 6410 || 117 || 6559 || 0 || 527 || 274 || 2750 || 0 || 13663 || 61160

CYPRUS

Statistical data submitted

The statistical data were submitted by Veterinary Services of the Republic of Cyprus.

Comments of the Cypriot authorities

None

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 1328 || 1301 || 10 || || 17 ||

1.b. || Rats (Rattus norvegicus) || 0 || || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || ||

1.g. || Cats (Felis catus) || 0 || || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || || || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || || || || || ||

1.o. || Cattle (Bos) || || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 1328 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 1139 || 108 || || || || || 81 || || 1328

2.b. || Rats || || || || || || || || || 0

2.c. || Guinea-Pigs || || || || || || || || || 0

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || || || || || || || || || 0

2.g. || Cats || || || || || || || || || 0

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || || || || || || || || || 0

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || || || || || || || || || 0

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || || || || 0

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 1139 || 108 || 0 || 0 || 0 || 0 || 81 || 0 || 1328

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || || 211 || 183 || 157 || || 551

4.b. || Rats || || || || || || 0

4.c. || Guinea-Pigs || || || || || || 0

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || || || || || || 0

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || || || || || 0

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || || 0

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || || 0

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 0 || 211 || 183 || 157 || 0 || 551

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || || || 0 ||

5.b. || Rats || || || || || || || 0 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || || || || || || 0 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

LATVIA

Statistical data submitted

The statistical data were submitted by the State Food and Veterinary Service.

Comments of Latvian authorities

None

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 6300 || 6300 || || || ||

1.b. || Rats (Rattus norvegicus) || 4020 || 4020 || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || ||

1.g. || Cats (Felis catus) || 0 || || || || ||

1.h. || Dogs (Canis familiaris) || 9 || || 9 || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || || || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || || || || || ||

1.o. || Cattle (Bos) || || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 10329 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 1200 || 2111 || 2989 || || || || || || 6300

2.b. || Rats || 1370 || 527 || 2123 || || || || || || 4020

2.c. || Guinea-Pigs || || || || || || || || || 0

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || || || || || || || || || 0

2.g. || Cats || || || || || || || || || 0

2.h. || Dogs || || 9 || || || || || || || 9

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || || || || || || || || || 0

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || || || || || || || || || 0

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || || || || 0

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 2570 || 2647 || 5112 || 0 || 0 || 0 || 0 || 0 || 10329

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total

3.a. || Mice || || || || || || || || || || 0

3.b. || Rats || || || || || || || || || || 0

3.c. || Guinea-Pigs || || || || || || || || || || 0

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || || || || || || || || || || 0

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || || || || || || || || || || 0

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 854 || 1587 || 291 || 579 || || 3311

4.b. || Rats || 605 || 1002 || || 290 || || 1897

4.c. || Guinea-Pigs || || || || || || 0

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || || || || || || 0

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || 9 || || 9

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || || || || || 0

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || || 0

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || || 0

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 1459 || 2589 || 291 || 878 || 0 || 5217

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || 2989 || || || || || 2989 ||

5.b. || Rats || || 2123 || || || || || 2123 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || || || || || || 0 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 0 || 5112 || 0 || 0 || 0 || 0 || 5112 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

 

LITHUANIA

Statistical data submitted

The statistical data have been submitted by the Animal Health and Welfare Department of the State Food and Veterinary Service of the Republic of Lithuania.

Comments of Lithuanian authorities

The legal basis for the collection of statistics on the number and use of vertebrate animals for experimental and other scientific purposes in Lithuania is provided by:

The State Food and Veterinary Service Director Decree No B1-639 (Government Gazette 2009, No  8-287) on the protection of animals used for experimental and other scientific purposes, in accordance with Council Directive 86/609/EEC and European Convention on the protection of animals used for experimental and other scientific purposes.

The total number of animals used in experiments in Lithuania in 2011 was 4,067.

Rodents accounted for 88,64% of all animals used – 3,605 animals (2,131 mice – accounting for 59,11 %, 1,297 rats - accounting for 35,98 %, 177 guinea pigs – accounting for 4,91 %).

Rabbits represent 6,74 % (274 animals).

Cold-blooded animals (amphibians) represented 3,66 % of the animals used – 149 animals, of which 100 % were used for education and training purposes.

Pigs accounted for 0,5 % of the animals used (19 animals), of which 52,63 % were used for research and development of products and devices for human medicine and dentistry and for veterinary medicine, 47,37 % for diagnosis of disease purposes.

Birds accounted for 0,5 % (20 animals), of which 100% were used for research and development of products and devices for  human medicine and dentistry and for veterinary medicine.

No primates were used.

No animals have been used for cosmetics testing.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 2131 || 2131 || || || ||

1.b. || Rats (Rattus norvegicus) || 1297 || 1297 || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 177 || 177 || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 274 || 274 || || || ||

1.g. || Cats (Felis catus) || 0 || || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || 19 || || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || || || || || ||

1.o. || Cattle (Bos) || || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 20 || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || 149 || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 4067 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 TABLE 2:    NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 574 || 1014 || 25 || || 200 || 309 || 9 || || 2131

2.b. || Rats || 670 || 506 || || || 26 || 90 || 5 || || 1297

2.c. || Guinea-Pigs || 55 || 110 || || || 7 || || 5 || || 177

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || 53 || 206 || || || 7 || 2 || 6 || || 274

2.g. || Cats || || || || || || || || || 0

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || || 10 || || || || 9 || || || 19

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || || || || || || || || || 0

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || 20 || || || || || || || 20

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || 149 || || 149

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 1352 || 1866 || 25 || 0 || 240 || 410 || 174 || 0 || 4067

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total

3.a. || Mice || || || || || || || 200 || || || 200

3.b. || Rats || || || || || || || 26 || || || 26

3.c. || Guinea-Pigs || || || || || || || 7 || || || 7

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || || || || || || || 7 || || || 7

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || || || || || || || || || || 0

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 240 || 0 || 0 || 240

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || || || 300 || 400 || || 700

4.b. || Rats || || || || || || 0

4.c. || Guinea-Pigs || || || || || || 0

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || || || || || || 0

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || || || || || 0

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || || 0

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || || 0

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || 43 || || 43

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 0 || 0 || 300 || 443 || 0 || 743

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 25 || || || || || || 25 ||

5.b. || Rats || || || || || || || 0 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || || || || || || 0 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 25 || 0 || 0 || 0 || 0 || 0 || 25 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || || 200 || || || || 200 ||

6.b. || Rats || || || 26 || || || || 26 ||

6.c. || Guinea-Pigs || || || 7 || || || || 7 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || || 7 || || || || 7 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || || || 0 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || || || 0 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || || || || || || 0 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || || 0 ||

6.y. || Fish || || || || || || || 0 ||

6.z. || TOTAL || 0 || 0 || 240 || 0 || 0 || 0 || 240 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino-genicity || 7.8 Develop-mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || || || || || || || || || || || || 200 || 200

7.b. || Rats || || || || || || || || || || || || || 26 || 26

7.c. || Guinea-Pigs || || || || || || || || || || || || || 7 || 7

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || || || || || || || || || || || 7 || 7

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || || || || || || || || || || || || 0

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || || 0

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || || || || || || || || 0

7.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 240 || 240

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || || || || || || || || || || || 200 || 200

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || 26 || 26

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || 7 || 7

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || 7 || 7

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || || || || || || || || || || || || || || 0

8.j. || TOTAL || || || || || || || || || || || || || || 0

LUXEMBOURG

Statistical data submitted

The statistical data were submitted by the 'Ministère de l’Agriculture, de la viticulture et du développement rural. Administration des Services Vétérinaires' (Ministry of Agriculture, viticulture and rural development. Administration of Veterinary Services).

Comments of Luxembourg authorities

None

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 470 || 470 || || || ||

1.b. || Rats (Rattus norvegicus) || 32 || 32 || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || ||

1.g. || Cats (Felis catus) || 0 || || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || || || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || || || || || ||

1.o. || Cattle (Bos) || || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 502 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 470 || || || || || || || || 470

2.b. || Rats || 32 || || || || || || || || 32

2.c. || Guinea-Pigs || || || || || || || || || 0

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || || || || || || || || || 0

2.g. || Cats || || || || || || || || || 0

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || || || || || || || || || 0

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || || || || || || || || || 0

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || || || || 0

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 502 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 502

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 100 || 50 || 280 || 40 || || 470

4.b. || Rats || 20 || 12 || || || || 32

4.c. || Guinea-Pigs || || || || || || 0

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || || || || || || 0

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || || || || || 0

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || || 0

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || || 0

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 120 || 62 || 280 || 40 || 0 || 502

HUNGARY

Statistical data submitted

The statistical data were submitted by the Ministry of Rural Development.

Comments of the Hungarian authorities

The total number of animals used for experimental and other scientific purposes in 2011 was 276.179 which represents a 9,4% decrease compared to the same figure of 2008.

The use of other rodents, goats and reptiles fell to zero. The decrease was considerable in the number of cattle (94,6%), horses and donkeys (77,5%), hamsters (59%), amphibians (38,7%), rats (20,7%), and sheep (20%).

On the other hand the use of fish more than doubled and eighteen times as many quals were used than in 2008.

The trend of monkeys turned in the past few years: no new world monkey were used, but the number of old world monkeys grew.

Compared to 2008 no rabbits, but cats were re-used.

The amount of animals used for production and quality control of products and devices for veterinary medicine (more than doubled) and for toxicological and other safety evaluations (almost doubled) were increased , but a lot less (half) were used to education and training.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 143755 || 104761 || 38678 || 316 || 0 || 0

1.b. || Rats (Rattus norvegicus) || 70873 || 56330 || 13520 || 1023 || 0 || 0

1.c. || Guinea-Pigs (Cavia porcellus) || 9228 || 9101 || 81 || 46 || 0 || 0

1.d. || Hamsters (Mesocricetus ) || 88 || 88 || 0 || 0 || 0 || 0

1.e. || Other Rodents (other Rodentia) || 0 || 0 || 0 || 0 || 0 || 0

1.f. || Rabbits (Oryctolagus cuniculus) || 7567 || 7233 || 13 || 321 || 0 || 0

1.g. || Cats (Felis catus) || 34 || 25 || 9 || 0 || 0 || 20

1.h. || Dogs (Canis familiaris) || 675 || 370 || 144 || 161 || 0 || 88

1.i. || Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 0 || 0 || 0 || 0 || 0 || 0

1.k. || Horses, donkeys and cross breds (Equidae) || 9 || 0 || 0 || 0 || 0 || 0

1.l. || Pigs (Sus) || 1278 || 79 || 2 || 0 || 0 || 0

1.m. || Goats (Capra) || 0 || 0 || 0 || 0 || 0 || 0

1.n. || Sheep (Ovis) || 160 || 0 || 0 || 0 || 0 || 0

1.o. || Cattle (Bos) || 5 || 0 || 0 || 0 || 0 || 0

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 7 || 7 || 0 || 0 || 0 || 0

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0

1.u. || Quail (Coturnix coturnix) || 235 || 235 || 0 || 0 || 0 || 0

1.v. || Other birds (other Aves) || 36304 || 0 || 0 || 0 || 0 || 0

1.w. || Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0

1.x. || Amphibians (Amphibia) || 725 || 0 || 0 || 0 || 0 || 0

1.y. || Fish (Pisces) || 5236 || 2142 || 0 || 0 || 0 || 0

1.z. || TOTAL || 276179 || 26269 || 7891 || 1577 || 0 || 0

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 34512 || 69495 || 15833 || 2992 || 15649 || 3175 || 829 || 1270 || 143755

2.b. || Rats || 22398 || 32540 || 111 || 0 || 12961 || 20 || 2123 || 720 || 70873

2.c. || Guinea-Pigs || 436 || 781 || 858 || 1508 || 5398 || 0 || 169 || 78 || 9228

2.d. || Hamsters || 88 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 88

2.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.f. || Rabbits || 2128 || 772 || 221 || 1077 || 3052 || 110 || 207 || 0 || 7567

2.g. || Cats || 14 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 34

2.h. || Dogs || 228 || 89 || 0 || 0 || 340 || 0 || 18 || 0 || 675

2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.k. || Horses, donkeys and cross breds || 0 || 8 || 0 || 0 || 1 || 0 || 0 || 0 || 9

2.l. || Pigs || 885 || 101 || 0 || 252 || 39 || 0 || 1 || 0 || 1278

2.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.n. || Sheep || 6 || 37 || 0 || 112 || 0 || 0 || 0 || 5 || 160

2.o. || Cattle || 2 || 0 || 0 || 0 || 3 || 0 || 0 || 0 || 5

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.r. || Old World Monkeys || 7 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 7

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.u. || Quail || 0 || 0 || 0 || 0 || 235 || 0 || 0 || 0 || 235

2.v. || Other birds || 5177 || 1485 || 0 || 27725 || 30 || 15 || 146 || 1726 || 36304

2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.x. || Amphibians || 125 || 0 || 0 || 0 || 0 || 0 || 600 || 0 || 725

2.y. || Fish || 374 || 0 || 0 || 0 || 4198 || 100 || 564 || 0 || 5236

2.z. || TOTAL || 66380 || 105328 || 17023 || 33666 || 41906 || 3420 || 4657 || 3799 || 276179

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 10608 || 560 || 921 || 0 || 0 || 0 || 0 || 139 || 3421 || 15649

3.b. || Rats || 3909 || 958 || 269 || 0 || 0 || 0 || 0 || 219 || 7606 || 12961

3.c. || Guinea-Pigs || 3854 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 1524 || 5398

3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 1941 || 144 || 0 || 0 || 0 || 0 || 0 || 0 || 967 || 3052

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 196 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 144 || 340

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1

3.l. || Pigs || 37 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 39

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.o. || Cattle || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 235 || 235

3.v. || Other birds || 30 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 0 || 252 || 342 || 0 || 0 || 0 || 0 || 1720 || 1884 || 4198

3.z. || TOTAL || 20579 || 1934 || 1532 || 0 || 0 || 0 || 0 || 2078 || 15783 || 41906

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 993 || 61386 || 6711 || 15545 || 2316 || 86951

4.b. || Rats || 3537 || 33058 || 563 || 5954 || 0 || 43112

4.c. || Guinea-Pigs || 46 || 0 || 0 || 176 || 68 || 290

4.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0

4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0

4.f. || Rabbits || 518 || 13 || 0 || 174 || 198 || 903

4.g. || Cats || 0 || 0 || 0 || 0 || 9 || 9

4.h. || Dogs || 177 || 0 || 0 || 16 || 0 || 193

4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 1 || 1

4.l. || Pigs || 0 || 0 || 0 || 17 || 58 || 75

4.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0

4.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0

4.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 0 || 15 || 566 || 581

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 0 || 0 || 100 || 0 || 100

4.y. || Fish || 0 || 0 || 0 || 0 || 304 || 304

4.z. || TOTAL || 5271 || 94457 || 7274 || 21997 || 3520 || 132519

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 14094 || 4471 || 0 || 210 || 50 || 0 || 18825 ||

5.b. || Rats || 111 || 0 || 0 || 0 || 0 || 0 || 111 ||

5.c. || Guinea-Pigs || 215 || 2151 || 0 || 0 || 0 || 0 || 2366 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 13 || 1233 || 0 || 52 || 0 || 0 || 1298 ||

5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.l. || Pigs || 0 || 252 || 0 || 0 || 0 || 0 || 252 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 112 || 0 || 0 || 0 || 0 || 112 ||

5.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 0 || 27355 || 0 || 370 || 0 || 0 || 27725 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.z. || TOTAL || 14433 || 35574 || 0 || 632 || 50 || 0 || 50689 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 1155 || 11809 || 0 || 90 || 2112 || 483 || 15649 ||

6.b. || Rats || 466 || 5317 || 0 || 186 || 6903 || 89 || 12961 ||

6.c. || Guinea-Pigs || 0 || 1308 || 0 || 531 || 3559 || 0 || 5398 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 13 || 2154 || 0 || 0 || 885 || 0 || 3052 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 16 || 99 || 0 || 81 || 144 || 0 || 340 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 1 || 0 || 0 || 0 || 0 || 1 ||

6.l. || Pigs || 0 || 20 || 0 || 0 || 2 || 17 || 39 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.o. || Cattle || 0 || 3 || 0 || 0 || 0 || 0 || 3 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 235 || 0 || 235 ||

6.v. || Other birds || 0 || 30 || 0 || 0 || 0 || 0 || 30 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 1284 || 1094 || 0 || 20 || 1800 || 0 || 4198 ||

6.z. || TOTAL || 2934 || 21835 || 0 || 908 || 15640 || 589 || 41906 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 8746 || 0 || 2189 || 0 || 2574 || 0 || 0 || 0 || 0 || 269 || 0 || 0 || 1871 || 15649

7.b. || Rats || 3915 || 0 || 3008 || 0 || 0 || 0 || 2606 || 0 || 96 || 364 || 2008 || 0 || 964 || 12889

7.c. || Guinea-Pigs || 631 || 0 || 1291 || 0 || 1822 || 0 || 1582 || 0 || 0 || 0 || 0 || 0 || 72 || 5398

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 1866 || 377 || 0 || 328 || 0 || 0 || 0 || 0 || 362 || 0 || 119 || 3052

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 148 || 0 || 0 || 0 || 176 || 0 || 0 || 0 || 0 || 0 || 16 || 340

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1

7.l. || Pigs || 0 || 0 || 37 || 0 || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 39

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.o. || Cattle || 0 || 0 || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 155 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 80 || 235

7.v. || Other birds || 0 || 0 || 30 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 2327 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 712 || 1159 || 4198

7.z. || TOTAL || 15774 || 0 || 8573 || 377 || 4396 || 328 || 4366 || 0 || 96 || 633 || 2370 || 712 || 4281 || 41906

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 9377 || 0 || 6655 || 19 || 395 || 0 || 2630 || 0 || 96 || 0 || 488 || 0 || 919 || 20579

8.b. || Products/substances used or intended to be used mainly in agriculture || 1043 || 0 || 388 || 97 || 95 || 97 || 0 || 0 || 0 || 0 || 124 || 0 || 90 || 1934

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 0 || 772 || 0 || 0 || 0 || 0 || 418 || 0 || 342 || 0 || 1532

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 1220 || 0 || 130 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 370 || 358 || 2078

8.i. || Other toxicological or safety evaluations || 4134 || 0 || 1400 || 261 || 3134 || 231 || 1736 || 0 || 0 || 215 || 1758 || 0 || 2914 || 15783

8.j. || TOTAL || 15774 || 0 || 8573 || 377 || 4396 || 328 || 4366 || 0 || 96 || 633 || 2370 || 712 || 4281 || 41906

MALTA

Statistical data submitted

The data were submitted by the Ministry for Resources and Rural Affairs, Veterinary and Phytosanitary Regulation Department.

Comments of Malta authorities

None

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 0 || || || || ||

1.b. || Rats (Rattus norvegicus) || 0 || || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || 0 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || ||

1.g. || Cats (Felis catus) || 0 || || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || 0 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 0 || || || || ||

1.l. || Pigs (Sus) || 0 || || || || ||

1.m. || Goats (Capra) || 0 || || || || ||

1.n. || Sheep (Ovis) || 0 || || || || ||

1.o. || Cattle (Bos) || 0 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || 10 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 0 || || || || ||

1.w. || Reptiles (Reptilia) || 0 || || || || ||

1.x. || Amphibians (Amphibia) || 0 || || || || ||

1.y. || Fish (Pisces) || 0 || || || || ||

1.z. || TOTAL || 10 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2 TABLE 2:    NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || || || || || || || || || 0

2.b. || Rats || || || || || || || || || 0

2.c. || Guinea-Pigs || || || || || || || || || 0

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || || || || || || || || || 0

2.g. || Cats || || || || || || || || || 0

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || || || || || || || || || 0

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || || || || || || || || || 0

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || 10 || || || || || || || || 10

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || || || || 0

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 10

 

THE NETHERLANDS

Statistical data submitted

The statistical data were prepared, quality assured and submitted by the 'Nederlandse Voedsel en Waren Autoriteit' (Netherlands Food and Consumer Product Safety Authority).

Comments of the Dutch authorities

On 5 February 1997, the revised version of the Experiments on Animals Act (1977) entered into force.

The provisions of the European Directive on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (86/609/EEC) have been implemented.

In addition, among others the following provisions have been issued:

- Animal experiments using LD50/LC50 methods are prohibited. However, for acute dermal and acute respiratory toxicity tests a general exemption is granted, due to the lack of validated alternative methods.

- Animal experiments for new or existing cos­metics are prohibited.

- Since 2003 animal experiments on great apes are prohibited.

- Every animal experi­ment to be performed has to be recommen­ded by a recognised ethical review commit­tee. Such a committee com­prises at least se­ven me­m­bers, one of whom is the chair­per­son. In addition, such a committee comprises in equal numbers experts in the fields of animal experiments, experts in the field of alternative methods, experts in the field of animal welfare and protection and experts in the field of ethical assessment. At least two of these experts are not involved in the con­duct of experiments on animals. The chairperson and at least two members are not in the employ of any licence holder applying to the committee. The animal welfare officer is involved already at an early stage in the review of experiments and acts as a permanent advisor for the ethical review commit­tee. At this moment 23 ethical review committees are recognized.

Licenses to perform animal experiments are issued by the Minister of Public Health, Welfare and Sport to a natural or legal person who is a mandated representative of an establishment for animal use. So licensed, those people are responsible for assur­ing that the legal requirements are complied with. The welfare of the experi­mental animals is supervised by a qualified veterinarian or another compet­ent person in charge of the licensee.

A Standing Committee advises the Minister on the admi­nistra­tion of the Act and other related issues. The Committee consists of experts in the field of animal experimenta­tion, laboratory animal science and animal welfare.

The enforcement of the Act has been commissioned to the Netherlands Food and Consumer Product Safety Authority.

The creation of transgenic animals

In 2011, for the creation of transgenic animals, 12,251 animals (11,494 mice, 546 rats, 48 other birds and 163 fish) were used.

Breeding of animals which had a fenotype with harmful effect

In 2011 there were 11,890 animals used for breeding which had a fenotype with harmful effects. Concerning 11,015 genetically altered mice, 172 genetically altered rats and 703 mice without a genetical modification

Collection of data

72 establishments completed the 2011 regist­ration form.

These establishments can be categorized as follows:

a) Univer­si­t­ies and university hospitals                                                               15

b) Pub­lic health research institutes                                                                         4

c) Agricultural and veterinary research institutes                                                  3

d) Other research institutes                                                                                    4

e) Industries and companies                                                                                38

f) Schools for vocational training                                                                          6

g) Breeders                                                                                                            2

The killing of an animal without any previous intervention

In the Netherlands, the killing of an animal without any previous intervention in the framework of research or testing, e.g. for organ/blood collecti­on, is con­side­red to be an experiment. The rationale of this is that the Inspectorate must have the power to super­vise the killing of laboratory animals.

This is in contrast to the Council of Europe Convention ETS 123 and Directive 86/609/EEC, where the use of an animal for an experimental or other scientific purpose is not considered an experiment if the least painful method of killing accepted in modern practice  (‘humane’ methods’) is used.

In 2011, 67,196 animals were killed without previous intervention.

Re-use of the animals (in 2011, 8,077 animals) is included as well in the Dutch statistics

Total number of animals used

In 2011, according to the EU Tables, the total number of animals used was 514,617.

This is 3,2% (16,314) more than the number of animals used in 2010 (498,303).

The total number of genetically modified animals that was used was 93,349. When split up into species, the numbers of genetically modified animals used are: 89,704 mice, 419 rats, 200 rabbits and 3,026 fish.

Discomfort 

General

Data has to be registered after an experiment has been performed. This includes data on the degree of discom­fort; i.e. experienced discomfort.

As a consequence of the animal experiments performed in 2008:

· 36,35% of the animals experienced minor discomfort;

· 29,30% of the animals experienced minor/moderate discomfort;

· 21,67% of the animals experienced moderate discomfort;

· 8,98% of the animals experienced moderate/severe discomfort;

· 3,68% of the animals experienced severe discomfort; and

· 0.02% of the animals experienced very severe discomfort.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 237 784 || 202 725 || 31 817 || || 3 242 ||

1.b. || Rats (Rattus norvegicus) || 98 881 || 57 765 || 41 029 || || 87 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 5 493 || 3 191 || 2 287 || || 15 ||

1.d. || Hamsters (Mesocricetus ) || 3 632 || 3 476 || 156 || || 0 ||

1.e. || Other Rodents (other Rodentia) || 979 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 6 293 || 1 614 || 4 651 || || 28 || 138

1.g. || Cats (Felis catus) || 174 || 103 || 0 || || 71 || 22

1.h. || Dogs (Canis familiaris) || 692 || 415 || 149 || || 128 || 289

1.i. || Ferrets (Mustela putorius furo) || 852 || 0 || 666 || || 186 || 14

1.j. || Other Carnivores (other Carnivora) || 430 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 2 371 || || || || ||

1.l. || Pigs (Sus) || 14 686 || || || || ||

1.m. || Goats (Capra) || 284 || || || || ||

1.n. || Sheep (Ovis) || 2 600 || || || || ||

1.o. || Cattle (Bos) || 2 383 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 22 || 0 || 0 || || 22 || 1

1.r. || Old World Monkeys (Cercopithecoidea) || 184 || 73 || 20 || || 91 || 111

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || || 0 || 0

1.t. || Other Mammals (other Mammalia) || 41 || || || || ||

1.u. || Quail (Coturnix coturnix) || 68 || 68 || 0 || || 0 ||

1.v. || Other birds (other Aves) || 99 354 || || || || ||

1.w. || Reptiles (Reptilia) || 133 || || || || ||

1.x. || Amphibians (Amphibia) || 1 247 || || || || ||

1.y. || Fish (Pisces) || 36 034 || || || || ||

1.z. || TOTAL || 514 617 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 166 354 || 30 471 || 4 930 || 14 372 || 5 229 || 9 380 || 7 048 || || 237 784

2.b. || Rats || 28 621 || 4 886 || 28 937 || 5 802 || 27 619 || || 3 016 || || 98 881

2.c. || Guinea-Pigs || 505 || 524 || 829 || 3 465 || 116 || || 54 || || 5 493

2.d. || Hamsters || 432 || 245 || || 2 916 || || || 39 || || 3 632

2.e. || Other Rodents || 699 || 280 || || || || || || || 979

2.f. || Rabbits || 498 || 402 || 366 || 1 973 || 2 872 || 28 || 154 || || 6 293

2.g. || Cats || 49 || || || 38 || || || 87 || || 174

2.h. || Dogs || 164 || 101 || || 183 || 152 || || 92 || || 692

2.i. || Ferrets || 282 || 497 || 58 || || || || 15 || || 852

2.j. || Other Carnivores || 121 || || || 309 || || || || || 430

2.k. || Horses, donkeys and cross breds || 24 || 194 || 101 || 2 030 || || || 22 || || 2 371

2.l. || Pigs || 8 925 || 3 387 || 6 || 1 671 || 43 || || 654 || || 14 686

2.m. || Goats || 139 || 137 || || 1 || || || 7 || || 284

2.n. || Sheep || 274 || 273 || 1 900 || 26 || || || 127 || || 2 600

2.o. || Cattle || 586 || 883 || 237 || 307 || || || 370 || || 2 383

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || 5 || 17 || || || || || || || 22

2.r. || Old World Monkeys || 39 || 145 || || || || || || || 184

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || 39 || 2 || || || || || || || 41

2.u. || Quail || 68 || || || || || || || || 68

2.v. || Other birds || 65 293 || 11 532 || 22 || 21 180 || || 281 || 1 046 || || 99 354

2.w. || Reptiles || 133 || || || || || || || || 133

2.x. || Amphibians || 127 || || || || 1 120 || || || || 1 247

2.y. || Fish || 31 967 || || || || 3 580 || || 487 || || 36 034

2.z. || TOTAL || 305 344 || 53 976 || 37 386 || 54 273 || 40 731 || 9 689 || 13 218 || 0 || 514 617

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total

3.a. || Mice || 3 020 || 80 || 1 985 || || || 144 || || || || 5 229

3.b. || Rats || 7 127 || 6 150 || 14 093 || 28 || || 200 || || || 21 || 27 619

3.c. || Guinea-Pigs || 67 || || 49 || || || || || || || 116

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 1 783 || || 1 089 || || || || || || || 2 872

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || 152 || || || || || || || || || 152

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || 43 || || || || || || || || || 43

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || 1 120 || || 1 120

3.y. || Fish || || || || || || || || 3 372 || 208 || 3 580

3.z. || TOTAL || 12 192 || 6 230 || 17 216 || 28 || 0 || 344 || 0 || 4 492 || 229 || 40 731

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 18 898 || 17 365 || 52 091 || 71 800 || 11 253 || 171 407

4.b. || Rats || 3 625 || 11 731 || 1 350 || 9 474 || 139 || 26 319

4.c. || Guinea-Pigs || 0 || 55 || 0 || 391 || 430 || 876

4.d. || Hamsters || 0 || 0 || 0 || 168 || 245 || 413

4.e. || Other Rodents || 0 || 0 || 0 || 288 || 0 || 288

4.f. || Rabbits || 230 || 0 || 164 || 411 || 54 || 859

4.g. || Cats || 0 || 0 || 0 || 0 || 42 || 42

4.h. || Dogs || 68 || 0 || 0 || 43 || 154 || 265

4.i. || Ferrets || 0 || 0 || 0 || 779 || 0 || 779

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 10 || 184 || 194

4.l. || Pigs || 421 || 0 || 32 || 188 || 3 737 || 4 378

4.m. || Goats || 33 || 0 || 0 || 147 || 34 || 214

4.n. || Sheep || 10 || 0 || 0 || 271 || 266 || 547

4.o. || Cattle || 0 || 0 || 0 || 19 || 969 || 988

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 1 || 0 || 17 || 0 || 18

4.r. || Old World Monkeys || 0 || 0 || 0 || 169 || 0 || 169

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 10 || 0 || 10

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 100 || 373 || 26 516 || 26 989

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0

4.y. || Fish || 0 || 4 162 || 119 || 936 || 184 || 5 401

4.z. || TOTAL || 23 285 || 33 314 || 53 856 || 85 494 || 44 207 || 240 156

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || 1 320 || || 1 864 || 11 596 || 4 522 || 19 302 ||

5.b. || Rats || || 4 354 || || 684 || 29 053 || 648 || 34 739 ||

5.c. || Guinea-Pigs || || 190 || || 250 || 2 034 || 1 820 || 4 294 ||

5.d. || Hamsters || || || || || 2 916 || || 2 916 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || 1 || || 70 || 1 892 || 376 || 2 339 ||

5.g. || Cats || || || || || 38 || || 38 ||

5.h. || Dogs || || || || || 168 || 15 || 183 ||

5.i. || Ferrets || || || || || || 58 || 58 ||

5.j. || Other Carnivores || || || || || || 309 || 309 ||

5.k. || Horses, donkeys and cross breds || || || || || 82 || 2 049 || 2 131 ||

5.l. || Pigs || || || || || 1 290 || 387 || 1 677 ||

5.m. || Goats || || || || || || 1 || 1 ||

5.n. || Sheep || || || || || 2 || 1 924 || 1 926 ||

5.o. || Cattle || 25 || || || 4 || 104 || 411 || 544 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || 18 381 || 2 821 || 21 202 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 25 || 5 865 || 0 || 2 872 || 67 556 || 15 341 || 91 659 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || || || 5 || 3 598 || 1 626 || 5 229 ||

6.b. || Rats || || || || 80 || 27 346 || 193 || 27 619 ||

6.c. || Guinea-Pigs || || || || || 114 || 2 || 116 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || || || || 2 863 || 9 || 2 872 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || 152 || || 152 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || 33 || 10 || 43 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || || || || || || 0 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || 1 120 || || 1 120 ||

6.y. || Fish || || || || || 3 072 || 508 || 3 580 ||

6.z. || TOTAL || 0 || 0 || 0 || 85 || 38 298 || 2 348 || 40 731 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino-genicity || 7.8 Develop- mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || 1 525 || 210 || || 2 577 || || || || || 877 || || || 40 || 5 229

7.b. || Rats || || 617 || 5 173 || 179 || || || 968 || 610 || 10 211 || 83 || 9 479 || || 299 || 27 619

7.c. || Guinea-Pigs || || || 63 || || 49 || || || || || || || || 4 || 116

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || 109 || 162 || || 136 || 170 || || || || 1 177 || || 1 118 || 2 872

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || 99 || || || || 40 || || || || || || 13 || 152

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || 29 || || || || || || || || || || 14 || 43

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || 1 120 || || || || || || || || || || || 1 120

7.y. || Fish || 570 || 288 || 605 || || || || 2 117 || || || || || || || 3 580

7.z. || TOTAL || 570 || 2 430 || 7 408 || 341 || 2 626 || 136 || 3 295 || 610 || 10 211 || 960 || 10 656 || 0 || 1 488 || 40 731

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta-genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 1 657 || 2 789 || 100 || 1 255 || 48 || 610 || || 783 || 103 || 3 447 || || 1 400 || 12 192

8.b. || Products/substances used or intended to be used mainly in agriculture || || 16 || 455 || || || || 200 || 610 || || || 4 913 || || 36 || 6 230

8.c. || Products/substances used or intended to be used mainly in industry || || 465 || 2 383 || 241 || 1 347 || 88 || 200 || || 9 428 || 716 || 2 296 || || 52 || 17 216

8.d. || Products/substances used or intended to be used mainly in the household || || 4 || 24 || || || || || || || || || || || 28

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || 32 || || 24 || || 168 || || || 120 || || || || 344

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 570 || 288 || 1 725 || || || || 1 909 || || || || || || || 4 492

8.i. || Other toxicological or safety evaluations || || || || || || || 208 || || || 21 || || || || 229

8.j. || TOTAL || 570 || 2 430 || 7 408 || 341 || 2 626 || 136 || 3 295 || 610 || 10 211 || 960 || 10 656 || 0 || 1 488 || 40 731

COMMISSION STAFF WORKING DOCUMENT

Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

PART B IV: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

TABLE OF CONTENTS

AUSTRIA................................................................................................................................... 5

POLAND.................................................................................................................................. 18

PORTUGAL............................................................................................................................. 29

ROMANIA............................................................................................................................... 37

SLOVENIA.............................................................................................................................. 37

SLOVAKIA............................................................................................................................. 37

FINLAND................................................................................................................................ 37

SWEDEN................................................................................................................................. 37

UNITED KINGDOM.............................................................................................................. 37

AUSTRIA

Statistical data submitted

The statistical data were submitted by the 'Bundesministerium für Wissenschaft und Forschung' (Federal Ministry of Science and Research).

Comments of the Austrian authorities

Slight increase of animal numbers by 2.1% compared to previous year. 85% of animals used are mice and rats. Internationally Compared Low Animal Numbers in Austria. Rise in animal numbers primarily for R&D and production and quality control of pharmaceuticals. No great apes used, No animal experiments for cosmetics. In long term comparison reduction in animal numbers of 61% since 1990. Statistics in EU-wide standardized form.

After 2 years of decrease, the number of animals used in procedures in Austria during 2011 has risen again for the first time. The increase in 2011 is 2.1% as compared to 2010, however the numbers are still lower than in previous years (7,9 % lower than in 2009 and 13,2 % lower than in 2008). The animal use statistics for 2011 shows that in total 191,288 animals were used in procedures in Austria.

Compared to previous years, this total number lies within the range of variation of the last years, yet is still well below the number of the earliest years. Relative to 1990 (the year statistics were recorded for the first time, in which year 482,166 animals were used in procedures) the number of animals is reduced by about 61%.

Development of the numbers of animals used since 1990.

Breakdown according to areas of competence.

A breakdown of the numbers according to areas of competence for administration of the Animal Experiments Law ranks them as follows:

Health (BMG: Federal Ministry of Health - primarily R & D for pharmaceuticals, production and quality control of pharmaceuticals and medicinal products, animal health products) is placed first with 116,613 (61 %) animals, before

Science and Research (BMWF: Federal Ministry of Science and Research: universities, Austrian Academy of Sciences, etc. - primarily basic research, in particular health related research) which is second with 68.024 (35 %) animals,

Industry (BMWFJ: Federal Ministry of Economy, Family and Youth - primarily basic research) comes in third with 4.807 (3 %) animals and

Environmental Protection and Agriculture (BMLFUW: Federal Ministry of Agriculture, Forestry, Environment and Water Management - primarily safety testing of chemicals and protection of the environment) is last with 1.884 (1 %) animals used.

Predominantly mice and rats are used as experimental animals

Of the total number of 191.288 animals used in procedures in Austria during 2011 were:

           

162.179                       84,78%                        mice and rats

15.633                         8,17%                          rabbits

4.006                           2,09%                          guinea pigs

3.797                           1,98%                          agricultural animals

3.267                           1,71%                          birds

1.940                           1,01%                          fish

201                              0,11%                          small animals (hamsters, ferrets, other rodents)

176                              0,09%                          amphibia and reptiles

89                                0,05%                          dogs and cats

 

 

Animal Tests for Humans and Animals

The number of animals used in procedures in 2011 - with 85% (162,179) predominantly mice and rats – is generally due to increased biomedical research in Austria as well as businesses active in biomedical, pharmaceutical and biological research and production. This research and development was directed to production and quality control of human and veterinary pharmaceuticals and medicinal products manufactured for the international market and for combating severe diseases such as cancer or cardiovascular diseases.

A significant part was also devoted to the development, production and quality control of vaccines for the international market, in particular vaccines (testing of charges) for which there was a demand from health authorities all over the world. The major part of rabbits and guinea pigs was used for these purposes.

In scientific and basic research the aims were inter alia improvement of the knowledge in the area of cancer research and development of effective therapies with reduced side effects or stress for the patients. Fundamental and applied research was conducted on cardiovascular diseases (myocardial infarction and its consequences) and neurological disorders (e.g. Alzheimer, Parkinson and prion-related diseases). 

Increased biomedical research as well as the development of pharmaceuticals and medicinal products requires animal tests - as a first step and precondition for clinical testing on humans – in the interest of health and safety of humans and animals. The same is also true for quality control of pharmaceuticals and medicinal products.

Last but not least, animal tests are also required for animal health, meaning that for the development of veterinary pharmaceuticals it is necessary to conduct clinical studies on animal patients, and animal tests are similarly necessary for the development of diagnostic and therapeutic measures for animals. The major part of agricultural animals was used for these purposes.

No animal experiments for cosmetics

In accordance with the legal prohibition of animal experiments for cosmetics (§ 3 Abs. 5 Tierversuchsgesetz) in force since 1999 there were naturally no animal experiments carried out for cosmetics.

No great apes used

It is particularly gratifying that in 2011 in Austria no animal experiments on great apes were carried out, in accordance with the legal prohibition of animal experiments on great apes which is in force since January 1, 2006 (BGBl. I, Nr. 162/2005). This also reflects a general trend in Europe to restrict such experiments as far as possible and to avoid them altogether according to the best available science.

Statistics in EU-wide standardized form

In accordance with the amended Animal Experiments Law (BGBl. I, Nr. 169/1999) and the Ordinance on Animal Use Statistics (BGBl. II Nr. 199/2000) the Animal Use Statistics 2011 provides the statistical data in a standardized form and gives details about the origin of the animals, the purposes for which they were used (basic research, R&D for medicines and medicinal products, for quality control, etc.). 

Internationally Compared Low Animal Numbers in Austria

The number of animals used in procedures in Austria contributed less than 1.9 % to the total number of 12.0 million vertebrate animals used in Europe, as can be seen from the EU-wide animal use statistics for 2008 (the last year for which the European Commission  compiled such a statistics). In international comparison, the figures of animal numbers in Austria still remain low. These comparatively low numbers of animals are due to at least three interconnected developments in relation to animals experiments:

1. Application of „3R“

Firstly, scientists, researchers and users themselves apply the principles of the „3R“(Reduction, Refinement, Replacement) - which also guide the Austrian Animal Experiments Law - to the widest possible extent, as well as using alternatives.

2. Restrictive authorization practice for projects

Second, all authorities issue permits for projects very restrictively in accordance with the strict provisions of the Animal Experiments Law and the Ordinance on Animal Experiments, which allow animal experiments only under very restrictive conditions and stipulate that projects may only be permitted, if no other satisfactory methods are available to achieve the aim without using live animals.

3. Support for research on Alternative Methods to Animal Testing

Finally, public financial support for developing and promoting alternative methods contributes to motivation of users and researches:

3.1. Financial support for research projects aimed at developing alternative methods, totalling more than 2,562 Mio. EUR for 29 projects, as well as promoting the use of alternative methods nationally and internationally,

3.2. National Award for Alternative Methods, i.e. a specific award publicly recognizing scientific achievements in the area of alternative methods.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 153153 || 43464 || 106502 || 44 || 3143 ||

1.b. || Rats (Rattus norvegicus) || 9026 || 4593 || 4433 || 0 || 0 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 3797 || 1432 || 2365 || 0 || 0 ||

1.d. || Hamsters (Mesocricetus ) || 125 || 0 || 125 || 0 || 0 ||

1.e. || Other Rodents (other Rodentia) || 64 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 15633 || 12718 || 2899 || 0 || 16 || 20

1.g. || Cats (Felis catus) || 14 || 12 || 2 || 0 || 0 || 8

1.h. || Dogs (Canis familiaris) || 75 || 0 || 0 || 0 || 75 || 0

1.i. || Ferrets (Mustela putorius furo) || 12 || 0 || 12 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 0 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 128 || || || || ||

1.l. || Pigs (Sus) || 1553 || || || || ||

1.m. || Goats (Capra) || 60 || || || || ||

1.n. || Sheep (Ovis) || 683 || || || || ||

1.o. || Cattle (Bos) || 1582 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 0 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 1940 || || || || ||

1.w. || Reptiles (Reptilia) || 0 || || || || ||

1.x. || Amphibians (Amphibia) || 176 || || || || ||

1.y. || Fish (Pisces) || 3267 || || || || ||

1.z. || TOTAL || 191288 || || || || ||

Note 1:       Column 1.5 concerns only those Member countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 58092 || 44836 || 45925 || 0 || 1523 || 1186 || 969 || 622 || 153153

2.b. || Rats || 4977 || 2656 || 144 || 0 || 966 || 18 || 215 || 50 || 9026

2.c. || Guinea-Pigs || 31 || 293 || 2331 || 0 || 1142 || 0 || 0 || 0 || 3797

2.d. || Hamsters || 49 || 0 || 76 || 0 || 0 || 0 || 0 || 0 || 125

2.e. || Other Rodents || 64 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 64

2.f. || Rabbits || 100 || 331 || 14539 || 6 || 624 || 0 || 27 || 6 || 15633

2.g. || Cats || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 12 || 14

2.h. || Dogs || 20 || 0 || 0 || 0 || 0 || 6 || 19 || 30 || 75

2.i. || Ferrets || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 0 || 12

2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.k. || Horses, donkeys and cross breds || 118 || 0 || 0 || 0 || 0 || 0 || 0 || 10 || 128

2.l. || Pigs || 301 || 979 || 0 || 0 || 28 || 29 || 216 || 0 || 1553

2.m. || Goats || 18 || 2 || 0 || 0 || 0 || 0 || 0 || 40 || 60

2.n. || Sheep || 109 || 2 || 0 || 0 || 0 || 70 || 50 || 452 || 683

2.o. || Cattle || 180 || 4 || 0 || 0 || 0 || 44 || 140 || 1214 || 1582

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.v. || Other birds || 1192 || 602 || 4 || 0 || 0 || 6 || 136 || 0 || 1940

2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.x. || Amphibians || 176 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 176

2.y. || Fish || 3008 || 0 || 0 || 0 || 221 || 0 || 38 || 0 || 3267

2.z. || TOTAL || 68435 || 49719 || 63019 || 6 || 4504 || 1359 || 1810 || 2436 || 191288

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contaminants in the general environment which do not appear in other columns || 3.10 Other toxicological or safety evaluations || 3.11 Total

3.a. || Mice || 1099 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 424 || 1523

3.b. || Rats || 242 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 724 || 966

3.c. || Guinea-Pigs || 128 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1014 || 1142

3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 474 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 150 || 624

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.l. || Pigs || 28 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 98 || 221

3.z. || TOTAL || 1971 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 2410 || 4504

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 4578 || 8013 || 22611 || 49401 || 24 || 84627

4.b. || Rats || 378 || 1586 || 1269 || 3624 || 4 || 6861

4.c. || Guinea-Pigs || 6 || 5 || 0 || 363 || 0 || 374

4.d. || Hamsters || 49 || 0 || 0 || 76 || 0 || 125

4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0

4.f. || Rabbits || 18 || 27 || 1 || 820 || 8 || 874

4.g. || Cats || 0 || 0 || 0 || 0 || 14 || 14

4.h. || Dogs || 0 || 0 || 0 || 0 || 11 || 11

4.i. || Ferrets || 0 || 0 || 0 || 12 || 0 || 12

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0

4.l. || Pigs || 180 || 0 || 1 || 349 || 474 || 1004

4.m. || Goats || 0 || 0 || 0 || 2 || 0 || 2

4.n. || Sheep || 18 || 0 || 0 || 16 || 9 || 43

4.o. || Cattle || 4 || 0 || 0 || 0 || 204 || 208

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 0 || 30 || 1570 || 1600

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 10 || 0 || 0 || 0 || 10

4.y. || Fish || 1152 || 0 || 0 || 1115 || 210 || 2477

4.z. || TOTAL || 6383 || 9641 || 23882 || 55808 || 2528 || 98242

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 0 || 5706 || 0 || 0 || 40219 || 0 || 45925 ||

5.b. || Rats || 104 || 0 || 0 || 0 || 0 || 40 || 144 ||

5.c. || Guinea-Pigs || 0 || 181 || 0 || 0 || 2125 || 25 || 2331 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 76 || 0 || 76 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 0 || 7459 || 0 || 0 || 6912 || 174 || 14545 ||

5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 0 || 0 || 0 || 0 || 4 || 0 || 4 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.z. || TOTAL || 104 || 13346 || 0 || 0 || 49336 || 239 || 63025 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 0 || 1045 || 0 || 0 || 478 || 0 || 1523 ||

6.b. || Rats || 0 || 32 || 0 || 0 || 934 || 0 || 966 ||

6.c. || Guinea-Pigs || 0 || 54 || 0 || 0 || 1088 || 0 || 1142 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 0 || 260 || 0 || 7 || 357 || 0 || 624 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 28 || 28 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 0 || 0 || 0 || 0 || 221 || 0 || 221 ||

6.z. || TOTAL || 0 || 1391 || 0 || 7 || 3078 || 28 || 4504 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 0 || 0 || 945 || 0 || 0 || 0 || 34 || 0 || 0 || 424 || 0 || 0 || 120 || 1523

7.b. || Rats || 0 || 532 || 32 || 0 || 0 || 0 || 402 || 0 || 0 || 0 || 0 || 0 || 0 || 966

7.c. || Guinea-Pigs || 0 || 0 || 54 || 0 || 1088 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1142

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 23 || 107 || 30 || 0 || 108 || 22 || 0 || 0 || 0 || 0 || 0 || 334 || 624

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.l. || Pigs || 0 || 0 || 0 || 28 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 0 || 98 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 0 || 221

7.z. || TOTAL || 0 || 653 || 1138 || 58 || 1088 || 108 || 458 || 0 || 0 || 424 || 0 || 123 || 454 || 4504

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 0 || 23 || 1138 || 28 || 74 || 0 || 266 || 0 || 0 || 0 || 0 || 0 || 442 || 1971

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 0 || 123

8.i. || Other toxicological or safety evaluations || 0 || 630 || 0 || 30 || 1014 || 108 || 192 || 0 || 0 || 424 || 0 || 0 || 12 || 2410

8.j. || TOTAL || 0 || 653 || 1138 || 58 || 1088 || 108 || 458 || 0 || 0 || 424 || 0 || 123 || 454 || 4504

POLAND

Statistical data submitted

The statistical data were submitted by the Ministry of Science and Higher Education, Warsaw.

Comments of the Polish authorities

In Poland the Ministry of Science and Higher Education is responsible for gathering the statistical data on the use of animals for scientific purposes and sending the to the European Commission.

The first report on number of animals used for scientific purposes in Poland passed to EC concerned 2005. Since then, the number of animals used for scientific purposes is maintained at a stable level – an average of about 250,000 animals per year.

In 2011 282,160 animals were used for scientific purposes in Poland. Report on number of animals used for scientific purposes was submitted in 2012 to the Ministry of Science and Higher Education by 94 authorized experimental units. The largest group of animals used for research constitutes fish, mice and rats.

The following table and graph present a comparison of the species of animals used for scientific purposes in 2011 compared to 2010.

2011 || 2010

Species || Number         Percentage  || Species || Number        Percentage 

Mice || 95 115 || 33,70 % || Mice || 88 040 || 38,66 %

Rats || 38 171 || 13,53 % || Rats || 49 050 || 21,54 %

Guinea-Pigs || 8943 || 3,17 % || Guinea-Pigs || 7 626 || 3,35 %

Other Rodents || 11 710 || 4,15 % || Other Rodents || 10 069 || 4,42 %

Other birds || 13 615 || 5,88 % || Other birds || 16 151 || 7 %

Fish || 100 275 || 35,54 % || Fish || 42 467 || 18,65 %

Other animals || 13 899 || 4,92 % || Other animals || 14  274 || 6,26 %

The increase in 2011 of used fish, mice and rats for scientific purposes is due to increased number of experiments carried out on animals in Poland. It is correlated with establishing in 2011 new financing research agency (National Centre for Research) funding research grants for basic research.

The primary purpose for which animals were used in experiments in 2011 is biological studies of fundamental nature. For this kind of research 72.91 % of animals were used from all animals used for scientific purposes in 2011. A large group of animals used for scientific purposes in 2011 constitutes animals used in projects for research and development of products and devices for human medicine and density and for veterinary medicine (9.7% of all animals used for scientific purposes in 2011) and concerning production and quality control of products and devices for human medicine and density (5.8 % of animals used for scientific purposes in 2011). For other categories of research 9.85 % of animals were used. For the purposes of education and training 4,877 animals were used in 2011 representing 1.73%.

The below graph shows the usage of animals in 2011 in Poland by a particular purpose of research.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 95 115 || 91577 || 1551 || 1319 || 668 ||

1.b. || Rats (Rattus norvegicus) || 38 171 || 30451 || 522 || 7173 || 25 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 8943 || 8839 || 104 || 0 || 0 ||

1.d. || Hamsters (Mesocricetus ) || 278 || 278 || 0 || 0 || 0 ||

1.e. || Other Rodents (other Rodentia) || 11710 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 2198 || 2186 || 0 || 0 || 12 || 527

1.g. || Cats (Felis catus) || 480 || 480 || 0 || 0 || 0 || 0

1.h. || Dogs (Canis familiaris) || 229 || 187 || 0 || 0 || 42 || 0

1.i. || Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 2149 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 766 || || || || ||

1.l. || Pigs (Sus) || 1147 || || || || ||

1.m. || Goats (Capra) || 396 || || || || ||

1.n. || Sheep (Ovis) || 379 || || || || ||

1.o. || Cattle (Bos) || 3489 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 594 || || || || ||

1.u. || Quail (Coturnix coturnix) || 1247 || 1247 || 0 || 0 || 0 ||

1.v. || Other birds (other Aves) || 13615 || || || || ||

1.w. || Reptiles (Reptilia) || 15 || || || || ||

1.x. || Amphibians (Amphibia) || 964 || || || || ||

1.y. || Fish (Pisces) || 100275 || || || || ||

1.z. || TOTAL || 282160 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 57785 || 15787 || 9500 || 2529 || 3611 || 4340 || 1222 || 341 || 95115

2.b. || Rats || 23112 || 8013 || 1342 || 400 || 3288 || 1523 || 307 || 186 || 38171

2.c. || Guinea-Pigs || 86 || 2248 || 4453 || 932 || 916 || 300 || 0 || 8 || 8943

2.d. || Hamsters || 272 || 0 || 0 || 0 || 0 || 0 || 6 || 0 || 278

2.e. || Other Rodents || 11264 || 0 || 0 || 0 || 0 || 230 || 216 || 0 || 11710

2.f. || Rabbits || 501 || 465 || 757 || 26 || 255 || 25 || 155 || 14 || 2198

2.g. || Cats || 23 || 4 || 0 || 0 || 0 || 390 || 63 || 0 || 480

2.h. || Dogs || 72 || 0 || 0 || 0 || 0 || 97 || 60 || 0 || 229

2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.j. || Other Carnivores || 1142 || 0 || 0 || 0 || 0 || 457 || 550 || 0 || 2149

2.k. || Horses, donkeys and cross breds || 738 || 0 || 0 || 0 || 0 || 13 || 15 || 0 || 766

2.l. || Pigs || 661 || 136 || 0 || 62 || 149 || 84 || 55 || 0 || 1147

2.m. || Goats || 250 || 0 || 0 || 0 || 0 || 0 || 106 || 40 || 396

2.n. || Sheep || 277 || 67 || 0 || 0 || 0 || 15 || 20 || 0 || 379

2.o. || Cattle || 2658 || 64 || 0 || 110 || 0 || 412 || 215 || 30 || 3489

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 541 || 0 || 0 || 0 || 0 || 53 || 0 || 0 || 594

2.u. || Quail || 453 || 0 || 0 || 0 || 10 || 0 || 4 || 780 || 1247

2.v. || Other birds || 9195 || 580 || 334 || 2176 || 0 || 535 || 449 || 346 || 13615

2.w. || Reptiles || 12 || 0 || 0 || 0 || 0 || 0 || 3 || 0 || 15

2.x. || Amphibians || 214 || 0 || 0 || 0 || 0 || 0 || 750 || 0 || 964

2.y. || Fish || 96484 || 0 || 0 || 0 || 1630 || 1000 || 681 || 480 || 100275

2.z. || TOTAL || 205740 || 27364 || 16386 || 6235 || 9859 || 9474 || 4877 || 2225 || 282160

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total

3.a. || Mice || 757 || 160 || 0 || 0 || 0 || 110 || 0 || 0 || 2584 || 3611

3.b. || Rats || 433 || 458 || 33 || 0 || 0 || 680 || 0 || 150 || 1534 || 3288

3.c. || Guinea-Pigs || 489 || 266 || 33 || 0 || 0 || 0 || 0 || 0 || 128 || 916

3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 173 || 46 || 36 || 0 || 0 || 0 || 0 || 0 || 0 || 255

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 149 || 0 || 149

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 10

3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.y. || Fish || 0 || 1207 || 423 || 0 || 0 || 0 || 0 || 0 || 0 || 1630

3.z. || TOTAL || 1852 || 2147 || 525 || 0 || 0 || 790 || 0 || 299 || 4246 || 9859

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 1408 || 29588 || 7893 || 8254 || 1830 || 48973

4.b. || Rats || 1748 || 13374 || 824 || 4663 || 295 || 20904

4.c. || Guinea-Pigs || 33 || 72 || 0 || 28 || 0 || 133

4.d. || Hamsters || 0 || 0 || 62 || 0 || 300 || 362

4.e. || Other Rodents || 0 || 286 || 0 || 30 || 0 || 316

4.f. || Rabbits || 0 || 12 || 40 || 305 || 5 || 362

4.g. || Cats || 0 || 0 || 4 || 0 || 56 || 60

4.h. || Dogs || 0 || 0 || 7 || 0 || 110 || 117

4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 941 || 941

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 24 || 24

4.l. || Pigs || 66 || 0 || 0 || 82 || 50 || 198

4.m. || Goats || 0 || 0 || 0 || 100 || 0 || 100

4.n. || Sheep || 0 || 0 || 21 || 30 || 21 || 72

4.o. || Cattle || 0 || 0 || 0 || 40 || 140 || 180

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 118 || 118

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 640 || 0 || 0 || 360 || 1000

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0

4.y. || Fish || 0 || 0 || 0 || 0 || 1058 || 1058

4.z. || TOTAL || 3255 || 43972 || 8851 || 13532 || 5308 || 74918

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 2292 || 2692 || 0 || 505 || 0 || 6540 || 12029 ||

5.b. || Rats || 165 || 506 || 0 || 716 || 0 || 355 || 1742 ||

5.c. || Guinea-Pigs || 194 || 5101 || 0 || 90 || 0 || 0 || 5385 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 580 || 110 || 0 || 0 || 0 || 93 || 783 ||

5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.l. || Pigs || 2 || 60 || 0 || 0 || 0 || 0 || 62 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 110 || 110 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 334 || 1136 || 0 || 0 || 0 || 1040 || 2510 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 0 || 0 || 0 || || 0 || 0 ||

5.z. || TOTAL || 3567 || 9605 || 0 || 1311 || 0 || 8138 || 22621 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 108 || 1757 || 30 || 390 || 0 || 1326 || 3611 ||

6.b. || Rats || 0 || 1032 || 736 || 525 || 0 || 995 || 3288 ||

6.c. || Guinea-Pigs || 0 || 916 || 0 || 0 || 0 || 0 || 916 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 0 || 255 || 0 || 0 || 0 || 0 || 255 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.l. || Pigs || 0 || 0 || 0 || 149 || 0 || 0 || 149 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 10 || 0 || 0 || 0 || 0 || 10 ||

6.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 0 || 0 || 0 || 0 || 1630 || 0 || 1630 ||

6.z. || TOTAL || 108 || 3970 || 766 || 1064 || 1630 || 2321 || 9859 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcinogenicity || 7.8 Develop- mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 153 || 0 || 876 || 0 || 0 || 0 || 558 || 0 || 0 || 0 || 0 || 0 || 2024 || 3611

7.b. || Rats || 160 || 0 || 737 || 549 || 0 || 0 || 1125 || 0 || 256 || 0 || 0 || 0 || 461 || 3288

7.c. || Guinea-Pigs || 0 || 340 || 0 || 0 || 570 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 916

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 0 || 154 || 0 || 39 || 0 || 0 || 0 || 0 || 0 || 0 || 62 || 255

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 149 || 149

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 10

7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.y. || Fish || 1238 || 0 || 0 || 0 || 0 || 0 || 313 || 0 || 0 || 0 || 0 || 79 || 0 || 1630

7.z. || TOTAL || 1561 || 340 || 1613 || 703 || 570 || 39 || 1996 || 0 || 256 || 0 || 0 || 79 || 2702 || 9859

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcinogenicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 96 || 0 || 628 || 360 || 242 || 0 || 8 || 0 || 0 || 0 || 0 || 0 || 518 || 1852

8.b. || Products/substances used or intended to be used mainly in agriculture || 994 || 0 || 42 || 82 || 266 || 23 || 371 || 0 || 160 || 0 || 0 || 0 || 209 || 2147

8.c. || Products/substances used or intended to be used mainly in industry || 390 || 0 || 11 || 22 || 54 || 16 || 0 || 0 || 0 || 0 || 0 || 0 || 32 || 525

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 640 || 0 || 0 || 0 || 0 || 0 || 150 || 790

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 290 || 7 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 299

8.i. || Other toxicological or safety evaluations || 81 || 50 || 925 || 237 || 8 || 0 || 977 || 0 || 96 || 0 || 0 || 79 || 1793 || 4246

8.j. || TOTAL || 1561 || 340 || 1613 || 703 || 570 || 39 || 1996 || 0 || 256 || 0 || 0 || 79 || 2702 || 9859

PORTUGAL

Statistical data submitted

The statistical data were submitted by the 'Ministério da Agricultura, Desenvolvimento, Mar, Ambiente e Ordenamento do Território – Direcção Geral de Alimentação e Veterinária – Direcção de Serviços de Protecção Animal' (Ministry of Agriculture, Sea, Environment and Spatial Planning – General Direction of Feed and Veterinary – Directorate for Animal Protection).

Comments of the Portuguese authorities

1. Total number of animals used by species

In 2011, the total number of animals used for experimental and other scientific purposes in Portugal was 46,556.

Compared to the data of 2008, where the total number of used animals was 50888, it means that with regard to 2008 it was a decrease on the use of animals of 8,51%.

Mice are the most commonly used species representing 52,41% of the total number of animals.

The second most used group of animals was Rats (24,25%).

The third most used group is represented by the Cold-blooded animals (20,68%) and the fourth by the group of Artio and Perissodactyla with 1,29%.

Rodents with Rabbits represent 77,06% of the total number of animals used.

Non-human primates, as it has been used to happen in Portugal, continued to not being used.

Comparison with the data of the previous report (data of 2008)

The percentages of classes of animals used in 2008 (50,888 animals) and in 2011 (46,556 animals) are represented in the following table:

Class of animals || 2008 (%) || 2011 (%)

Mice || 78,23 || 52,41

Rats || 12,91 || 24,25

Guinea-pigs || 0,30 || 0,009

Hamsters and other rodents || 0,06 || 0,17

Rabbits || 0,19 || 0,22

Cold-blooded animals || 7,47 || 20,68

Quail and other birds || 0,31 || 0,93

Artio Perissodactyla || 0,52 || 1,29

Carnivors || 0,00 || 0,043

In 2011, looking at the data by groups of animals, the percentage of rodents and rabbits suffered a decrease, from 91,69% in 2008 to 77,06% in 2011 due to a decrease on mouse use. The noticed decrease on mouse use was the reflection of two circumstances:

several institutions were improving their establishments or moved to new facilities that had been built and therefore the use of animals was stopped. there was a substantial increase on the use of cold-blooded animals, from 7,47% in 2008, to 20,68% in 2011, mainly due to the increase on the use of fish models.

Among the group of the Cold-blooded animals, Fish were the most used animals to being used followed by the use of amphibians.

Within the Artiodactyla, Pigs were once again the most used animals (78,74%).

2.  Number of animals used by purposes of experiments

In 2011, the percentage of animals (total 46,556) used by purposes of experiments was the following:

· 87,92% of animals were used in “Fundamental biology”;

· 2,39% in “Research and development for human medicine, veterinary medicine, dentistry”;

· 0,21% in “Production and quality control of products and devices in human medicine and dentistry and veterinary medicine”;

· 2,32% in “Toxicological and other safety evaluation”;

· 2,80% in “Diagnosis of disease”;

· 3,22% in “Education and training”;

· 1,14% in “Other purposes”.

Referring to the use of species versus experimental purposes, the highest amount of use of Mice, Rats and Fish is in “Fundamental biology” and the highest second amount of use of Fish is in “Toxicological and other safety evaluation”.

Comparison with the data of the previous report (data of 2008)

From 2008 to 2011, there was only a decrease in the percentage of animals in two categories: “Research and development for human medicine, veterinary medicine, dentistry” and “Other purposes”, with the most significant decrease of 7,35% in the percentage of animals that were used for “Research and development for human medicine, veterinary medicine, dentistry”.

The percentage of animals used in the rest of the other categories increased, for example:

The most significant increase in 2011 was in the percentage of animals that were used for “Fundamental biology” which increased 4,1% (from 83,82%, in 2008, to 87,92%, in 2011).

The percentage of animals used for “Toxicological and other safety evaluation” increased from 0,61% to 2,32% and the percentage of animals used for “Education and training” increased from 1,83% to 3,22%.

3.  Number of animals used for “Toxicological and safety evaluation” by type of products

In 2011, the use of animals in “Toxicological and other safety evaluation” represents only 2,32%, which only refers to 1079 animals (28 mice, 102 rats and 949 fish), from the total of 46,556 animals that were used for experimental purposes in Portugal.

“Potential or actual contaminants in the general environment which do not appear in other columns” represents 53,29% of all the animals used for “Toxicological and other safety evaluation”. The other percentages of uses in this category are the following:

· “Products/substances or devices for human medicine and dentistry and for veterinary medicine” represent 13,35%.

· “Products/substances used or intended to be used mainly in agriculture” represent 18,63%.

· “Other toxicological or safety evaluations” represent 14,74%.

Comparison with the data of the previous report (data of 2008)

Compared to the data of 2008, in 2011 there was an increase on the use of animals in “Toxicological and other safety evaluation”.

The percentage of animals used for “Toxicological and other safety evaluation” increased from 0,61% to 2,32% (from 310 to 1,079 animals).

The data of 2011 refers to more two categories of products than the ones that had been tested in 2008.

Animals used to test “Products/substances or devices for human medicine and dentistry and for veterinary medicine” and “Products/substances used or intended to be used mainly in agriculture” were represented in 2011 but not in 2008.

“Potential or actual contaminants in the general environment which do not appear in other columns” represented, in 2008, 61,29% of the animals used for “Toxicological and other safety evaluation” and, in 2011, 53,29%;

“Other toxicological or safety evaluations” represented 38,71% in 2008 while, in 2011, 14,74%, which means that there was a decrease in 2011.

As in 2008, in 2011 the other groups of products/substances were not tested which means that, for example, there were no animals used for the purpose of evaluating the safety of Cosmetics or Additives in food for animal consumption.

4.  Number of animals used for the study of diseases

In 2011, the number of animals used for the “Studies on humans and animals diseases” was 20,973, which represents 45,05% of the total number of animals (46,556 animals) that were used.

The percentages of animals per type of diseases were:

· 1,79% in “Human cardiovascular diseases”;

· 25,50% in “Human nervous and mental disorder's;

· 5,63% in “Human cancer (excl. evaluation of carcino hazards)”;

· 65,72% in “Other human diseases”;

· 1,36% in “Specific animal diseases”.

The percentage of the number of animals used for studies of human diseases represents 98,64% (20,687 animals) of the total number of animals used for all studies of diseases (20,973 animals).

In 2011, the number of animals used to study animal diseases was only 286 (1,36%) while in 2008, that number had been 568 (3,85%), which means that in 2011, there was decrease in the use of animals for the study of animal diseases.

5.  Number of animals used for “Toxicological and other safety evaluations” by the types of tests

As referred previously, in 2011, the use of animals in “Toxicological and other safety evaluation” represents only 2,32%, which only refers to 1,079 animals, of a total of 46,556 animals that were used for experimental purposes in Portugal.

Comparison with the data of the previous report (data of 2008)

The percentages of animals used in toxicity tests for “Toxicological and other safety evaluation” in 2008 (310 animals) and in 2011 (1,079 animals) are represented in the following table:

Type of tests || 2008 (%) || 2011 (%)

Acute and sub-acute toxicity testing methods (including limit test) || 0 || 35,87

Irritation/sensitization tests || 0 || 0

Sub-chronic and chronic toxicity || 0 || 0

Mutagenicity and Carcinogenicity || 38,71 || 14,74

Reproductive and developmental toxicity || 0 || 0

Toxicity of aquatic vertebrates not included in other columns || 0 || 49,40

Other tests || 61,29 || 0

In 2011 there was an increase on the uses of tests compared to data of 2008, and the biggest increase (49,40%) occurred on the uses of “Toxicity of aquatic vertebrates not included in other columns”.

6.  Type of toxicity tests carried out for “Toxicological and other safety evaluations” of products

As pointed out previously, in 2011, the use of animals in “Toxicological and other safety evaluation” represents only 2,32%, which only refers to 1,079 animals, of a total of 46,556 animals that were used for experimental purposes in Portugal.

Comparison with the data of the previous report (data of 2008)

The numbers of animals used for “Toxicological and other safety evaluation” per types of products in 2008 (310 animals) and in 2011 (1079 animals) are represented in the following tables:

Types of products || 2008 (%) || 2011 (%)

Products/substances or devices for human medicine and dentistry and for veterinary medicine || 38,71 || 13,35

Products/ substances used or intended to be used mainly in agriculture || 0 || 18,63

Potential or actual contaminants in the general environment which do not appear in other columns || 61,29 || 53,29

Other toxicological or safety evaluations || 0 || 14,74

In 2011, the number of animals used to test “Products/substances or devices for human medicine and dentistry and for veterinary medicine” were 144 animals distributed in “LD50, LC50” and in “Other lethal methods”.

In 2011, in comparision to 2008, there was an increase of the number of animals used to test “Products/substances used or intended to be used mainly in agriculture” from 0% in 2008, to 18,63%, in 2011. All the animals were used in “Non lethal clinical signs methods”.

Related to the “Potential or actual contaminants in the general environment which do not appear in other columns”, in 2011 there was a decrease of 8%, compared the 2008, from 61,29%, in 2008, to 53,29%, in 2011. The tests that were performed in this category, were “Other lethal methods” and “Toxicity to aquatic vertebrates not included in other columns”.

 

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 24399 || 17341 || 5023 || || 2035 || 60

1.b. || Rats (Rattus norvegicus) || 11290 || 6784 || 4153 || || 353 || 24

1.c. || Guinea-Pigs (Cavia porcellus) || 4 || || 4 || || || 4

1.d. || Hamsters (Mesocricetus ) || 6 || || 6 || || ||

1.e. || Other Rodents (other Rodentia) || 74 || || || || 24 ||

1.f. || Rabbits (Oryctolagus cuniculus) || 102 || 90 || || || 12 ||

1.g. || Cats (Felis catus) || || || || || ||

1.h. || Dogs (Canis familiaris) || 20 || 20 || || || ||

1.i. || Ferrets (Mustela putorius furo) || || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || 474 || || || || ||

1.m. || Goats (Capra) || 99 || || || || ||

1.n. || Sheep (Ovis) || 29 || || || || ||

1.o. || Cattle (Bos) || || || || || ||

1.p. || Prosimians (Prosimia) || || || || || ||

1.q. || New World Monkeys (Ceboidea) || || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || || || || || ||

1.s. || Apes (Hominoidea) || || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || || || || || ||

1.v. || Other birds (other Aves) || 433 || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || 25 || || || || ||

1.y. || Fish (Pisces) || 9601 || || || || ||

1.z. || TOTAL || 46556 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 22005 || 558 || || || 28 || 1217 || 518 || 73 || 24399

2.b. || Rats || 10081 || 453 || || || 102 || 88 || 543 || 23 || 11290

2.c. || Guinea-Pigs || || || || || || || 4 || || 4

2.d. || Hamsters || || || || || || || || 6 || 6

2.e. || Other Rodents || 74 || || || || || || || || 74

2.f. || Rabbits || 16 || || || || || || 21 || 65 || 102

2.g. || Cats || || || || || || || || ||

2.h. || Dogs || || 20 || || || || || || || 20

2.i. || Ferrets || || || || || || || || ||

2.j. || Other Carnivores || || || || || || || || ||

2.k. || Horses, donkeys and cross breds || || || || || || || || ||

2.l. || Pigs || || 60 || || || || || 370 || 44 || 474

2.m. || Goats || || || 99 || || || || || || 99

2.n. || Sheep || || 24 || || || || || 5 || || 29

2.o. || Cattle || || || || || || || || ||

2.p. || Prosimians || || || || || || || || ||

2.q. || New World Monkeys || || || || || || || || ||

2.r. || Old World Monkeys || || || || || || || || ||

2.s. || Apes || || || || || || || || ||

2.t. || Other Mammals || || || || || || || || ||

2.u. || Quail || || || || || || || || ||

2.v. || Other birds || 113 || || || || || || || 320 || 433

2.w. || Reptiles || || || || || || || || ||

2.x. || Amphibians || 25 || || || || || || || || 25

2.y. || Fish || 8616 || || || || 949 || || 36 || || 9601

2.z. || TOTAL || 40930 || 1115 || 99 || 0 || 1079 || 1305 || 1497 || 531 || 46556

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || || || || || || || || || 28 || 28

3.b. || Rats || || || || || || || || || 102 || 102

3.c. || Guinea-Pigs || || || || || || || || || ||

3.d. || Hamsters || || || || || || || || || ||

3.e. || Other Rodents || || || || || || || || || ||

3.f. || Rabbits || || || || || || || || || ||

3.g. || Cats || || || || || || || || || ||

3.h. || Dogs || || || || || || || || || ||

3.i. || Ferrets || || || || || || || || || ||

3.j. || Other Carnivores || || || || || || || || || ||

3.k. || Horses, donkeys and cross breds || || || || || || || || || ||

3.l. || Pigs || || || || || || || || || ||

3.m. || Goats || || || || || || || || || ||

3.n. || Sheep || || || || || || || || || ||

3.o. || Cattle || || || || || || || || || ||

3.p. || Prosimians || || || || || || || || || ||

3.q. || New World Monkeys || || || || || || || || || ||

3.r. || Old World Monkeys || || || || || || || || || ||

3.s. || Apes || || || || || || || || || ||

3.t. || Other Mammals || || || || || || || || || ||

3.u. || Quail || || || || || || || || || ||

3.v. || Other birds || || || || || || || || || ||

3.w. || Reptiles || || || || || || || || || ||

3.x. || Amphibians || || || || || || || || || ||

3.y. || Fish || 144 || 201 || || || || || || 575 || 29 || 949

3.z. || TOTAL || 144 || 201 || || || || || || 575 || 159 || 1079

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || || 2335 || 856 || 12162 || 202 || 15555

4.b. || Rats || 372 || 2989 || 324 || 1597 || 12 || 5294

4.c. || Guinea-Pigs || || || || || ||

4.d. || Hamsters || || || || || ||

4.e. || Other Rodents || || 24 || || || || 24

4.f. || Rabbits || 4 || || || || 12 || 16

4.g. || Cats || || || || || ||

4.h. || Dogs || || || || || ||

4.i. || Ferrets || || || || || ||

4.j. || Other Carnivores || || || || || ||

4.k. || Horses, donkeys and cross breds || || || || || ||

4.l. || Pigs || || || || || 60 || 60

4.m. || Goats || || || || 24 || || 24

4.n. || Sheep || || || || || ||

4.o. || Cattle || || || || || ||

4.p. || Prosimians || || || || || ||

4.q. || New World Monkeys || || || || || ||

4.r. || Old World Monkeys || || || || || ||

4.s. || Apes || || || || || ||

4.t. || Other Mammals || || || || || ||

4.u. || Quail || || || || || ||

4.v. || Other birds || || || || || ||

4.w. || Reptiles || || || || || ||

4.x. || Amphibians || || || || || ||

4.y. || Fish || || || || || ||

4.z. || TOTAL || 376 || 5348 || 1180 || 13783 || 286 || 20973

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || || || ||

5.b. || Rats || || || || || || || ||

5.c. || Guinea-Pigs || || || || || || || ||

5.d. || Hamsters || || || || || || || ||

5.e. || Other Rodents || || || || || || || ||

5.f. || Rabbits || || || || || || || ||

5.g. || Cats || || || || || || || ||

5.h. || Dogs || || || || || || || ||

5.i. || Ferrets || || || || || || || ||

5.j. || Other Carnivores || || || || || || || ||

5.k. || Horses, donkeys and cross breds || || || || || || || ||

5.l. || Pigs || || || || || || || ||

5.m. || Goats || || 99 || || || || || 99 ||

5.n. || Sheep || || || || || || || ||

5.o. || Cattle || || || || || || || ||

5.p. || Prosimians || || || || || || || ||

5.q. || New World Monkeys || || || || || || || ||

5.r. || Old World Monkeys || || || || || || || ||

5.s. || Apes || || || || || || || ||

5.t. || Other Mammals || || || || || || || ||

5.u. || Quail || || || || || || || ||

5.v. || Other birds || || || || || || || ||

5.w. || Reptiles || || || || || || || ||

5.x. || Amphibians || || || || || || || ||

5.y. || Fish || || || || || || || ||

5.z. || TOTAL || || 99 || || || || || 99 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || 28 || || || || || 28 ||

6.b. || Rats || || 102 || || || || || 102 ||

6.c. || Guinea-Pigs || || || || || || || ||

6.d. || Hamsters || || || || || || || ||

6.e. || Other Rodents || || || || || || || ||

6.f. || Rabbits || || || || || || || ||

6.g. || Cats || || || || || || || ||

6.h. || Dogs || || || || || || || ||

6.i. || Ferrets || || || || || || || ||

6.j. || Other Carnivores || || || || || || || ||

6.k. || Horses, donkeys and cross breds || || || || || || || ||

6.l. || Pigs || || || || || || || ||

6.m. || Goats || || || || || || || ||

6.n. || Sheep || || || || || || || ||

6.o. || Cattle || || || || || || || ||

6.p. || Prosimians || || || || || || || ||

6.q. || New World Monkeys || || || || || || || ||

6.r. || Old World Monkeys || || || || || || || ||

6.s. || Apes || || || || || || || ||

6.t. || Other Mammals || || || || || || || ||

6.u. || Quail || || || || || || || ||

6.v. || Other birds || || || || || || || ||

6.w. || Reptiles || || || || || || || ||

6.x. || Amphibians || || || || || || || ||

6.y. || Fish || || 949 || || || || || 949 ||

6.z. || TOTAL || || 1079 || || || || || 1079 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || || || || || || || 28 || || || || || || 28

7.b. || Rats || || || || || || || || 102 || || || || || || 102

7.c. || Guinea-Pigs || || || || || || || || || || || || || ||

7.d. || Hamsters || || || || || || || || || || || || || ||

7.e. || Other Rodents || || || || || || || || || || || || || ||

7.f. || Rabbits || || || || || || || || || || || || || ||

7.g. || Cats || || || || || || || || || || || || || ||

7.h. || Dogs || || || || || || || || || || || || || ||

7.i. || Ferrets || || || || || || || || || || || || || ||

7.j. || Other Carnivores || || || || || || || || || || || || || ||

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || ||

7.l. || Pigs || || || || || || || || || || || || || ||

7.m. || Goats || || || || || || || || || || || || || ||

7.n. || Sheep || || || || || || || || || || || || || ||

7.o. || Cattle || || || || || || || || || || || || || ||

7.p. || Prosimians || || || || || || || || || || || || || ||

7.q. || New World Monkeys || || || || || || || || || || || || || ||

7.r. || Old World Monkeys || || || || || || || || || || || || || ||

7.s. || Apes || || || || || || || || || || || || || ||

7.t. || Other Mammals || || || || || || || || || || || || || ||

7.u. || Quail || || || || || || || || || || || || || ||

7.v. || Other birds || || || || || || || || || || || || || ||

7.w. || Reptiles || || || || || || || || || || || || || ||

7.x. || Amphibians || || || || || || || || || || || || || ||

7.y. || Fish || 96 || 90 || 201 || || || || || || || 29 || || 533 || || 949

7.z. || TOTAL || 96 || 90 || 201 || || || || || 130 || || 29 || || 533 || || 1079

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 96 || 48 || || || || || || || || || || || || 144

8.b. || Products/substances used or intended to be used mainly in agriculture || || || 201 || || || || || || || || || || || 201

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || ||

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || ||

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || ||

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || ||

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || ||

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || 42 || || || || || || || || || || 533 || || 575

8.i. || Other toxicological or safety evaluations || || || || || || || || 130 || || 29 || || || || 159

8.j. || TOTAL || 96 || 90 || 201 || || || || || 130 || || 29 || || 533 || || 1079

ROMANIA

Statistical data submitted

The data were submitted by the Directorate, National Sanitary Veterinary and Food Safety Authority.

Comments of Romania authorities

None

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 44575 || 44575 || || || || 1483

1.b. || Rats (Rattus norvegicus) || 5161 || 5161 || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 6607 || 6607 || || || || 824

1.d. || Hamsters (Mesocricetus ) || 263 || 263 || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 2195 || 2195 || || || || 444

1.g. || Cats (Felis catus) || 0 || || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 14 || 14 || || || ||

1.l. || Pigs (Sus) || 2 || 2 || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || 131 || 131 || || || || 11

1.o. || Cattle (Bos) || 3 || 3 || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || 9 || 9 || || || ||

1.v. || Other birds (other Aves) || 1196 || 1196 || || || || 12

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 60156 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 1448 || 2620 || 8243 || 8008 || 5358 || 17559 || 140 || 1189 || 44565

2.b. || Rats || 952 || 263 || || || 345 || 3266 || 150 || || 5171

2.c. || Guinea-Pigs || || 56 || 2622 || 148 || 671 || 1447 || 1663 || || 6607

2.d. || Hamsters || 263 || || || || || || || || 263

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || || 65 || 1409 || 80 || 69 || 526 || 5 || 41 || 2195

2.g. || Cats || || || || || || || || || 0

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || 2 || 9 || 3 || || || || || 14

2.l. || Pigs || || || || 2 || || || || || 2

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || || || 112 || 2 || || || || 17 || 131

2.o. || Cattle || || || 3 || || || || || || 3

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || 9 || || || 9

2.v. || Other birds || || 66 || || 747 || || 286 || || 97 || 1196

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 2663 || 3072 || 12398 || 8990 || 6443 || 23093 || 1958 || 1344 || 60156

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 4783 || || 35 || 40 || 40 || 25 || || || 295 || 5218

3.b. || Rats || 50 || 80 || || 115 || 10 || 25 || || || 205 || 485

3.c. || Guinea-Pigs || 671 || || || || || || || || || 671

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 69 || || || || || || || || || 69

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || || || || || || || || || || 0

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 5573 || 80 || 35 || 155 || 50 || 50 || 0 || 0 || 500 || 6443

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 259 || 236 || 300 || 443 || 1620 || 2858

4.b. || Rats || 56 || 430 || 250 || 221 || || 957

4.c. || Guinea-Pigs || || || || 25 || 4 || 29

4.d. || Hamsters || 103 || 30 || || 120 || || 253

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || 3 || || || || 1 || 4

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || || || || || 0

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || || 0

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || || 0

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 421 || 696 || 550 || 809 || 1625 || 4101

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || || 16251 || 16251 ||

5.b. || Rats || || || || || || || ||

5.c. || Guinea-Pigs || || || || || || 2770 || 2770 ||

5.d. || Hamsters || || || || || || || ||

5.e. || Other Rodents || || || || || || || ||

5.f. || Rabbits || || || || || || 1489 || 1489 ||

5.g. || Cats || || || || || || || ||

5.h. || Dogs || || || || || || || ||

5.i. || Ferrets || || || || || || || ||

5.j. || Other Carnivores || || || || || || || ||

5.k. || Horses, donkeys and cross breds || || || || || || 12 || 12 ||

5.l. || Pigs || || || || || || 2 || 2 ||

5.m. || Goats || || || || || || || ||

5.n. || Sheep || || || || || || 114 || 114 ||

5.o. || Cattle || || || || || || 3 || 3 ||

5.p. || Prosimians || || || || || || || ||

5.q. || New World Monkeys || || || || || || || ||

5.r. || Old World Monkeys || || || || || || || ||

5.s. || Apes || || || || || || || ||

5.t. || Other Mammals || || || || || || || ||

5.u. || Quail || || || || || || || ||

5.v. || Other birds || || || || || || 747 || 747 ||

5.w. || Reptiles || || || || || || || ||

5.x. || Amphibians || || || || || || || ||

5.y. || Fish || || || || || || || ||

5.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 21388 || 21388 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || || || || || 5358 || 5358 ||

6.b. || Rats || || || || || || 345 || 345 ||

6.c. || Guinea-Pigs || || || || || || 671 || 671 ||

6.d. || Hamsters || || || || || || || ||

6.e. || Other Rodents || || || || || || || ||

6.f. || Rabbits || || || || || || 69 || 69 ||

6.g. || Cats || || || || || || || ||

6.h. || Dogs || || || || || || || ||

6.i. || Ferrets || || || || || || || ||

6.j. || Other Carnivores || || || || || || || ||

6.k. || Horses, donkeys and cross breds || || || || || || || ||

6.l. || Pigs || || || || || || || ||

6.m. || Goats || || || || || || || ||

6.n. || Sheep || || || || || || || ||

6.o. || Cattle || || || || || || || ||

6.p. || Prosimians || || || || || || || ||

6.q. || New World Monkeys || || || || || || || ||

6.r. || Old World Monkeys || || || || || || || ||

6.s. || Apes || || || || || || || ||

6.t. || Other Mammals || || || || || || || ||

6.u. || Quail || || || || || || || ||

6.v. || Other birds || || || || || || || ||

6.w. || Reptiles || || || || || || || ||

6.x. || Amphibians || || || || || || || ||

6.y. || Fish || || || || || || || ||

6.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 6443 || 6443 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 480 || 161 || 70 || 30 || 30 || 30 || 38 || || || || || || 4510 || 5349

7.b. || Rats || 90 || 105 || || || || || 4 || || || || || || 145 || 344

7.c. || Guinea-Pigs || || || || || || || 12 || || || || || || 669 || 681

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || || || || || || || || || || || 69 || 69

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || || || || || || || || || || || || 0

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || || 0

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || || || || || || || || 0

7.z. || TOTAL || 570 || 266 || 70 || 30 || 30 || 30 || 54 || 0 || 0 || 0 || 0 || 0 || 5393 || 6443

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 320 || 25 || 70 || 30 || 30 || 30 || 50 || || || || || || 5028 || 5583

8.b. || Products/substances used or intended to be used mainly in agriculture || 80 || || || || || || || || || || || || || 80

8.c. || Products/substances used or intended to be used mainly in industry || 15 || 20 || || || || || || || || || || || || 35

8.d. || Products/substances used or intended to be used mainly in the household || 40 || 115 || || || || || || || || || || || || 155

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 25 || 25 || || || || || || || || || || || || 50

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 25 || 25 || || || || || || || || || || || || 50

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || 65 || 56 || || || || || 4 || || || || || || 365 || 490

8.j. || TOTAL || 570 || 266 || 70 || 30 || 30 || 30 || 54 || 0 || 0 || 0 || 0 || 0 || 5393 || 6443

SLOVENIA

Statistical data submitted

The statistical data were submitted by the Veterinary Administration of the Republic of Slovenia (VARS).

Comments of Slovenian authorities

Commentary to the Annual Report on the Use of Animals in Procedures in 2011.

Veterinary Administration of the Republic of Slovenia (VARS) is the competent authority in the Republic of Slovenia for drawing up the Annual Report on the Use of Animals in Procedures, based on the Animal Protection Act (ZZZiv-UPB2, UL RS 43/2007). Procedures may be performed by establishments only, which have been authorised by VARS (25 user establishments) for conducting procedures on animals. Each user establishment designates an animal welfare expert, who collects data on the annual use of animals within the establishment in the form of 8 EU tables, which are submitted to VARS. VARS prepares a collective Annual Report on the Use of Animals in Procedures, which is made accessible to the public as information of public character.

As procedure on animals shall be regarded the use of animals for the experimental or other scientific purposes, which may cause pain, suffering, distress or lasting harm to the animals, and other measures, which may lead to or bring about a birth of an animal under such circumstances. In the Republic of Slovenia, procedures on animals are prohibited for the ethically unacceptable targets, as testing of weapons of war, cosmetic preparations, tobacco or alcohol products, or for procedures where the musculature paralysing agents are used without the appropriate anaesthesia. Use of animals for the educational purposes has been restricted, as procedures may be conducted only in the form of presentations to the students of veterinary medicine and of human medicine, provided that no alternative teaching aid (film, image, model, preparation etc) is at disposal.

In 2011, a total of 11,874 animals were used in procedures, which is by 4.54 % less animals as compared to 2008, where a total of 12,438 animals were used. A major portion constitute the laboratory rodents with 97.47 %, followed by rabbits with 1.97 %, fish with 0.35 %, and other animals (pigs, horses, sheep) with 0.20 % .

Laboratory rodents and rabbits originate from the Slovenian approved breeding establishments (28.07 %) and from the other EU Member States (the remaining portion). Other animals – rearing animals - originate from the agricultural holdings, where the animal owners give their consent in writing to the use of such animals in procedures.

Most animals were used in the applied research for the development, generation and control of quality of products and means intended for use in human medicine, dentistry and veterinary medicine, and to a lesser extent, for the assessment of toxicity (90.67 %). Only 8.00 % of the animals were used in baseline research studies, 0.60 % for the education and training purposes, 0.08 % for diagnosing diseases, and the remaining 0.65 % for other non-defined purposes of use.

Rabbits were reused in series of procedures within the applicable procedures for the identification of quality of products intended for use in human medicine, dentistry and veterinary medicine.

Pigs were used in the education of students of veterinary medicine and in the training of surgeons in human medicine. Seven horses were used in the research study of identifying the impacts of Vitamin E and Coenzyme Q10 on the oxidative stress within a certain physical activity of the recreational horses, 4 castrated male ovine animals were used in obtaining the ruminal fluid (juice) by operative insertion of a fistula for the nutritional research purposes, and 42 fish in their natural habitat were used for the telemetric monitoring purposes in the Sava River basin.

By the adoption of relevant legislation, and taking into account the 3R principle, and through an implemented control system, the use of animals in procedures has decreased over the recent five years, on the average to around 12,700 animals, where the laboratory rodents with over 95.00 % constitute a major portion. Non-human primates are not used in procedures, and neither the carnivores within the recent five years. Through the well-qualified staff involved in procedures on animals within the past 5-year period in Slovenia, the responsibility for and attitude towards the animals of the researchers have improved, which is reflected in the accurate keeping of procedure protocols, the careful selection of methods and in the subsequent precise implementation of procedures. In decreasing the number of animals used in procedures, in pharmaceutical industry in particular, the validated alternative methods and/or the use of cell cultures and tissues have had an important role.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 11133 || 3004 || 8129 || || ||

1.b. || Rats (Rattus norvegicus) || 393 || 250 || 143 || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 48 || 48 || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || 0 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 234 || 13 || 221 || || || 209

1.g. || Cats (Felis catus) || 0 || || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || 0 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 7 || || || || ||

1.l. || Pigs (Sus) || 13 || || || || ||

1.m. || Goats (Capra) || 0 || || || || ||

1.n. || Sheep (Ovis) || 4 || || || || ||

1.o. || Cattle (Bos) || 0 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || 0 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 0 || || || || ||

1.w. || Reptiles (Reptilia) || 0 || || || || ||

1.x. || Amphibians (Amphibia) || 0 || || || || ||

1.y. || Fish (Pisces) || 42 || || || || ||

1.z. || TOTAL || 11874 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 664 || 1962 || 7957 || 195 || || 10 || 30 || 28 || 10846

2.b. || Rats || 232 || 247 || || || 183 || || 18 || || 680

2.c. || Guinea-Pigs || 48 || || || || || || || || 48

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || || || 222 || || || || 12 || || 234

2.g. || Cats || || || || || || || || || 0

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || 7 || 7

2.l. || Pigs || 2 || || || || || || 11 || || 13

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || 4 || || || || || || || || 4

2.o. || Cattle || || || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || || || || 0

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || 42 || 42

2.z. || TOTAL || 950 || 2209 || 8179 || 195 || 183 || 10 || 71 || 77 || 11874

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || || || || || || || || || || 0

3.b. || Rats || 183 || || || || || || || || || 183

3.c. || Guinea-Pigs || || || || || || || || || || 0

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || || || || || || || || || || 0

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || || || || || || || || || || 0

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 183 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 183

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || || 253 || 1842 || 224 || || 2319

4.b. || Rats || 18 || 55 || || 342 || || 415

4.c. || Guinea-Pigs || || || || || || 0

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || || || || || || 0

4.g. || Cats || || || || || || 0

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || || || 2 || || 2

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || || || 0

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || || || 0

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 18 || 308 || 1842 || 568 || 0 || 2736

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || 8152 || || || || || 8152 ||

5.b. || Rats || || || || || || || 0 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || 222 || || || || || 222 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 0 || 8374 || 0 || 0 || 0 || 0 || 8374 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || || || || || || 0 ||

6.b. || Rats || || 183 || || || || || 183 ||

6.c. || Guinea-Pigs || || || || || || || 0 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || || || || || || 0 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || || || 0 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || || || 0 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || || || || || || 0 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || || 0 ||

6.y. || Fish || || || || || || || 0 ||

6.z. || TOTAL || 0 || 183 || 0 || 0 || 0 || 0 || 183 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || || || || || || || || || || || || || 0

7.b. || Rats || || 40 || || || || || || || || 143 || || || || 183

7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || || || || || || || || || || || || 0

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || || || || || || || || || || || || 0

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || || 0

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || || || || || || || || 0

7.z. || TOTAL || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 143 || 0 || 0 || 0 || 183

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 40 || || || || || || || || 143 || || || || 183

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || || || || || || || || || || || || || || 0

8.j. || TOTAL || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 143 || 0 || 0 || 0 || 183

SLOVAKIA

Statistical data submitted

The statistical data were submitted by the State Veterinary and Food Administration of the Slovak Republic.

Comments of Slovakian authorities

The State Veterinary and Food Administration of the Slovak Republic (hereinafter referred to as the „SVFA SR“) is a competent authority of the Slovak Republic in the matter of protection of animals used for experimental purposes. The SVFA SR approves in compliance with Article 6 paragraph 2 letter i) point 2 and 3 of Act No 39/2007 Coll. on Veterinary Care as amended (hereinafter referred to as „Act 39/2007 Coll“.), the performance of experiments on animals and breeding, supplying and experimental establishments. The original Ordinance of the Government of the Slovak Republic No 289/2003 Coll. by which the Directive 86/609/EEC was transposed into the legal order of the Slovak Republic, was amended in compliance with Commission recommendations 2007/526/EC of 18.06.2007, that concerned the accommodation and care of animals  used for experimental and other scientific purposes. On 1 February 2009 a new Ordinance of the Government of the Slovak Republic No 23/2009 Coll. entered into force (hereinafter referred to as the „Ordinance of the Government of the SR No 23/2009 Coll“.), in which the requirements for the protection of animals used for experimental or other scientific purposes are specified in detail. In this Ordinance the transitional period for harmonizing the requirements in respect of accommodation and care of animals from the year 2009 till 31.12.2013 was indicated.

The SVFA SR manages, directs, coordinates and controls 40 District Veterinary and Food Administrations (hereinafter referred to as the „DVFA“). All employees of the veterinary administration working in the field of animal protection are veterinarians participating in execution of controls in establishments. The controls are performed based on the methodical instructions and checklists worked out by the competent authority in compliance with requirements laid down in Ordinance of the Government of the SR No 23/2009 Coll. and in Act No 39/2007 Coll.

Approval of establishments:

All kinds of establishments are approved by the SVFA SR based on the application submitted by applicants and results from the control carried out directly in the establishment. By the control performed in the establishment the compliance with the observance of requirements laid down in Ordinance of the Government of the SR No 23/2009 Coll. are judged. In the establishment, mainly the control of applicant´s documents, control of records kept by an  applicant and  physical control of the establishment are performed.

All controls performed in establishments are non-discriminatory.  They are performed for the purpose of approval of the establishment, control of already approved establishments carried out for the purpose of compliance with requirements laid down in Ordinance of the Government of SR No 23/2009 Coll. or a control is performed on an impulse.

Totally, 24 establishments asked the SVFA SR for the approval of its establishment for keeping animals and performance of experiments on animals according to requirements laid down in Ordinance of the Government of the SR No 23/2009 Coll. In one approved establishment an additional approval of new premises– quarantine was carried out. One establishment fulfilled the requirements laid down in Ordinance of the Government of SR No 23/2009 Coll. during the execution of the control, for this reason it was not necessary to carry out the subsequent control.

Kinds and numbers of controls performed in establishments for the year 2011 in the Slovak Republic

Kind of the control || Number of controls

Judgement of suitability of the establishment for carrying out experiments || 25

Subsequent control || 23

Totally performed controls || 48

The SVFA SR after having issued the decision on approval of the establishment shall issue an official number to the respective establishment under which the establishment is kept in the lists of approved supplying, breeding and user establishments in the Slovak Republic on the website of the SVFA SR  www.svssr.sk. In compliance with paragraph 11 Article 39 of Act No 39/2007 Coll.  In the Slovak Republic is possible to breed the animals for the purpose of their usage in experiments only in approved breeding and supplying establishments. According to the Act, it is possible to perform the experiments on animals only in approved experimental establishments.

In the year 2011, the SVFA SR registered totally 66 approved establishments. Out of this, there were 53 experimental establishments, 10 experimental establishments bred animals for their own need, 2 breeding establishments and 1 supplying establishment. Compared to the year 2008, in which the report was given for individual Member States, the number of approved establishments was changed. Out of the total number of 75 approved establishments, the number decreased to 66 approved establishments. The changes concern mainly the number of experimental and breeding establishments.  Since the year 2009, several establishments submitted an application for cancellation of its approval.  It was due to the cancellation of the establishment itself, or change in respect of activity of the establishment. Many establishments were not able to fulfil the requirements concerning the care and accommodation of animals laid down in Ordinance of the Government of the SR No 23/2009 Coll. In the year 2011, some establishments e.g. of the Slovak Academy of Sciences divided according to kept animal species. It means, that one establishment has also 3 official numbers of approval according to animal species used in experiments.

Total number of approved establishments in the Slovak Republic in the year 2011.

Kind of establishment || Number of establishments

Experimental establishment || 53

Experimental establishment with breeding of animals for own use || 10

Breeding establishment || 2

Supplying establishment || 1

Total || 66

Approval of experiments:

In the Slovak Republic it is possible to use the animals only in approved experiments in approved experimental establishment.

The SVFA SR approves the experiments performed on animals based on the application for approval of an experiment, submitted by an applicant– approved experimental establishment. An application must be completed by the applicant in compliance with Article 8 of Ordinance of the Government of the SR No 23/2009. It must contain all the prescribed data concerning the used animals, mainly their species, number and origin, manner of their marking in the experiment, used anaesthesia within an experiment, performance of the experiment with indication of the aim, purpose of the experiment  and expected results. In an application the name of  a contracting veterinarian, a person submitting an experiment and person responsible for the care of animals are indicated. The document on the existence of the relevant alternative method to the submitted experiment shall be attached to each experiment. The applicant shall find out and search in internationally checked registers of alternative method the relevant alternative to the submitted experiment. A detailed specification of the manner of observance of principles 3R shall be attached to the application. An applicant shall submit the experiment first for the assessment to the ethic commission which shall be established according to the Act in each experimental establishment. The ethic commission is comprised of minimum 5 members, out of which 1/3 must not be dependent from the experimental establishment. The ethic commission on the submitted project of an experiment, shall assess the observance of principles 3R, existence of alternative method contrary to the submitted experiment, justification of each experiment, purpose and its aim, use of the animals in the experiment, caused pain. An applicant may submit his/her project of an experiment for approval by the SVFA SR only after recommendation for submission, issued by the ethic commission.

The SVFA SR has in compliance with Act No. 71/1967 Coll. on Administrative Proceedings (Administrative Codex) minimum 30 days for assessment of an application for approval of the experiment.  The SVFA SR, as a competent authority, may by the DECISION APPROVE, REFUSE, SUSPEND the performance of the experiment or may STOP an ADMINISTRATIVE PROCEEDINGS. The SVFA SR upon approval of experiments must observe the rules of the personal data protection and protection of data with signs of trade secret or intellectual property indicated in an application for approval of the experiment.

Since 01.01.2011, the SVFA SR approved experiments only to those establishments which were approved in compliance with requirements laid down in Ordinance of the Government of the SR No 23/2009 Coll. Therefore, the number of approved experiments for the year 2011 decreased, because not all registered establishments were still approved in compliance with new requirements laid down in Ordinance of the Government of the SR No 23/2009 Coll.

Survey on the number of approved experiments and on the number of interruptions of administrative proceedings:

Year || 2009 || 2010 || 2011 ||

Approval of experiment || 115 || 176 || 103 ||

Appeal for removal of deficiencies || 48 || 25 || 34 ||

Commentary to completed tables:

To the Table 1 Most of used animals originate from domestic approved breeding establishments or approved experimental establishments with breeding of animals for own use. The animals which originated from foreign suppliers or breeders originated from the EU Member States, mainly from the Czech Republic, Hungary, Germany, Poland or France. An increased number of animals repeatedly used in experiments (domestic rabbit 82 animals, 150 domestic fowl) is for the reason of an increased performance of experiments to order for the purpose of manufacture, development of substances intended for disease diagnostics. The hyperimmune sera from which the antibodies were purified, were obtained from immunized animals.

To the Table 2 The SVFA SR approved 103 experiments using experimental animals, stopped 34 administrative proceedings within experiment approval for the year 2011. The total number of animals used in experiments does not represent entirely the number of used animals for the year 2011. It is for the reason that into the indicated number of used animals in the year 2011 also animals are included, which were used from experiments approved already in the year 2009, 2010, 2011. In the Slovak Republic, the experiments are approved for the period of 3 years. In the column 2.8. the number of animals are indicated which were used within preparation of exepriments - so called pilot studies for performance of the experiment. The animals were used for the introduction of new surgical methods being used in the course of performance of experiments concerning demanding surgical interventions and other handling of animals. The pilot studies were approved by the competent authority as experiments. The usage of animals to obtain the necessary skills of persons performing the experiments – training of persons – the SVFA SR approved as a pre-experiment within the performance of the experiment. In the column 2.9 the numbers of animals used as a live collection for maintenance of viruses, parasites and breeding of ticks or animals used for preparation of primocultures are indiated. Each preparation of a collection was approved as a separate experiment.

To the Table 3. In the column 3.2 the animals were used for evaluation of products and substances for human medicine (testing of new medicines, medical devices, surgical supplies – suitability of new polymers in treatment of hernia). In the column 3.4 the numbers of animals are indicated which are used for the control of various chemical substances and substances e.g. for evaluation of human risk of amines, NH3, aldehydes, amides, alkylamides, nitrosamines as independent substances and their combinations, substances used as additive for slowing down or stopping the growth of microorganisms in paint substances, in fibres from plastic products or substances which are a part of fuel oils, lubricants and substances used in rubber industry. The orders for re-testing of the same substance produced in various batches were done in several establishments. In some cases, whole series of standard toxicological safety tests were carried out with the same substance, based on the EU legislation e.g. REACH. In the column 3.8 the animals were used for the purpose of testing the substance used in food industry as a supplement of food in a form of enterosolvent pellets of microcrystalline cellulose, either independent or enriched by lactose, or an influence of chosen feed additives was controlled. In the column 3.10 the numbers of animals are indicated with the aim to validate in in vivo experiments on animals findings of alternative in vitro experiments characterizing the toxicological profile of nanoelemens which will be perspectively used in further experiments for a toxicological evaluation of substances.

To the Table 4 Explanation to the column 4.5. The animals were used for the purpose of investigation of immune systems, infectious diseases and metabolism disorders in humans and in the column 4.6 in animals.

To the Table No 5 In the Slovak Republic the experiments upon animals are performed in compliance with the valid national legislation, in which the legal acts of the European Communities and the European Union are incorporated. In the column 5.3 the experiments are performed in compliance with the valid legislation of the European Pharmacopoeia. In the column 5.7 the methods for the control of human products/substances were used that were created by the experimental establishment as a modified method based on the approved pharmacopoeial methods or as a new individual method.

To the Table 6 The Slovak Republic has adopted the legislation in the field of medicines and medical devices e.g. Act No 362/2011 Coll. on Medicines and Medical Devices and on change and supplement of some acts, in the field of chemical substances and preparations the Act No 163/2001 Coll. on Chemical Substances and Preparations, we have adopted the Decree of the Ministry of Economy No 2/2005 Annex 5 Part B Methods B for testing of substances according to OECD methods that are conformable to OECD methods. The acts are elaborated and prepared in compliance with the EU legislation according to which the individual preparations, products are tested. In the column 6.3 the numbers of animals used in compliance with the European Pharmacopoeia are indicated.

To the Table 7 In the column 7.2.1. the tests were performed mainly by methods OECD TG 402, 423, 425. In the column 7.2.3 mainly the tests of the control of the product quality, tests of wholesomeness and efficiency according to the Slovak Pharmacopoeia 1 and the European Pharmacopoeia 6 were carried out.

In compliance with the Ordinance of the Government of the Slovak Republic No 23/2009 Coll. each approved establishment shall be obliged, in order to maintain its approval, to submit yearly to the SVFA SR a notification on the number of used animals for the respective year. The notification shall be submitted according to the specimen presented in the Ordinance of the Government. The approved establishments shall be obliged to keep records on the number of used GMO animals in the experiment. Based on the collected data, the SVFA SR shall yearly work out a notification about the activity of the SVFA SR in which the numbers of approved establishments, the numbers of approved and refused experiments as well as the numbers and species of used animals in the experiment for the respective year are published.

The competent authority performs consulting services for public in the field of animal welfare, organizes trainings for employees of approved establishments the purpose of which is interpretation of the valid legislation of the Slovak Republic in the field of animal welfare, it organizes seminars and lectures in respect of the protection of experimental animals used for experimental purposes.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 8747 || 6560 || 2187 || 0 || 0 || 0

1.b. || Rats (Rattus norvegicus) || 5327 || 3943 || 1384 || 0 || 0 || 0

1.c. || Guinea-Pigs (Cavia porcellus) || 645 || 329 || 316 || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || 17 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 299 || 237 || 62 || || || 82

1.g. || Cats (Felis catus) || 10 || 10 || || || ||

1.h. || Dogs (Canis familiaris) || 0 || || || || ||

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || || || || || ||

1.l. || Pigs (Sus) || 84 || || || || ||

1.m. || Goats (Capra) || || || || || ||

1.n. || Sheep (Ovis) || 14 || || || || || 5

1.o. || Cattle (Bos) || 0 || || || || || 1

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || || || || || ||

1.u. || Quail (Coturnix coturnix) || 88 || 88 || || || ||

1.v. || Other birds (other Aves) || 486 || || || || || 150

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 15717 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 4333 || 1561 || 0 || 403 || 188 || 2215 || 47 || 0 || 8747

2.b. || Rats || 3311 || 695 || 0 || 0 || 633 || 0 || 300 || 388 || 5327

2.c. || Guinea-Pigs || || 507 || || || || 100 || || 38 || 645

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || 17 || || || || || || || || 17

2.f. || Rabbits || 78 || 114 || 15 || 65 || 15 || 12 || || || 299

2.g. || Cats || 10 || || || || || || || || 10

2.h. || Dogs || || || || || || || || || 0

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || || || || || || || || || 0

2.k. || Horses, donkeys and cross breds || || || || || || || || || 0

2.l. || Pigs || 2 || 82 || || || || || || || 84

2.m. || Goats || || || || || || || || || 0

2.n. || Sheep || 5 || 9 || || || || || || || 14

2.o. || Cattle || || 0 || || || || || || || 0

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || || || || || || || || || 0

2.u. || Quail || 88 || || || || || || || || 88

2.v. || Other birds || 108 || || 45 || 216 || 90 || || || 27 || 486

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 7952 || 2968 || 60 || 684 || 926 || 2327 || 347 || 453 || 15717

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 188 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 188

3.b. || Rats || 275 || 0 || 118 || 0 || 0 || 0 || 90 || 0 || 150 || 633

3.c. || Guinea-Pigs || || || || || || || || || || 0

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 15 || || || || || || || || || 15

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || || || || || || || || || || 0

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || 90 || || || || || || || || || 90

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || || || 0

3.z. || TOTAL || 568 || 0 || 118 || 0 || 0 || 0 || 90 || 0 || 150 || 926

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 403 || 141 || 2019 || 3531 || 2015 || 8109

4.b. || Rats || 1586 || 914 || 297 || 1209 || || 4006

4.c. || Guinea-Pigs || || || || 607 || || 607

4.d. || Hamsters || || || || || || 0

4.e. || Other Rodents || 17 || || || || || 17

4.f. || Rabbits || || 60 || || 144 || || 204

4.g. || Cats || || || || 10 || || 10

4.h. || Dogs || || || || || || 0

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || || 2 || || 47 || 35 || 84

4.m. || Goats || || || || || || 0

4.n. || Sheep || || || || 9 || 5 || 14

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || 88 || || 88

4.v. || Other birds || || || || 108 || || 108

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 2006 || 1117 || 2316 || 5753 || 2055 || 13247

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 0 || 403 || 0 || 0 || 0 || 0 || 403 ||

5.b. || Rats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || 65 || || || || 15 || 80 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || 216 || || || || 45 || 261 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 0 || 684 || 0 || 0 || 0 || 60 || 744 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 0 || 188 || 0 || 0 || 0 || 0 || 188 ||

6.b. || Rats || 220 || 413 || 0 || 0 || 0 || 0 || 633 ||

6.c. || Guinea-Pigs || || || || || || || 0 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || 15 || || || || || 15 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || || || 0 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || || || 0 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || 90 || || || || || 90 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || || 0 ||

6.y. || Fish || || || || || || || 0 ||

6.z. || TOTAL || 220 || 706 || 0 || 0 || 0 || 0 || 926 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || || 20 || || || || 120 || || || 48 || || || || 188

7.b. || Rats || 55 || || || || || || 90 || || 220 || || 268 || || || 633

7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || || || 3 || 12 || || || || || || || || 15

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || || || || || || || || || || || || 0

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || || 0

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || 90 || || || || || || || || || || || 90

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || || || || || || || || 0

7.z. || TOTAL || 55 || 0 || 110 || 0 || 3 || 12 || 210 || 0 || 220 || 48 || 268 || 0 || 0 || 926

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 55 || || 110 || || 3 || 12 || 120 || || 70 || 48 || 150 || || || 568

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || 118 || || || 118

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || 90 || || || || || || || 90

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0

8.i. || Other toxicological or safety evaluations || || || || || || || || || 150 || || || || ||

8.j. || TOTAL || 55 || || 110 || 0 || 3 || 12 || 210 || 0 || 220 || 48 || 268 || 0 || 0 || 926

FINLAND

Statistical data submitted

The statistical data were collected by the Regional State Administrative Agency of Southern Finland and submitted by the Ministry of Agriculture and Forestry.

Comments of Finnish authorities

In 2011, a total of 136,043 experimental animals were used in Finland. From the year 2008 with 138,600 animals, no significant changes have been seen in the numbers of animals used or reasons for their use. 

Of all experimental animals used 68% were mice (73,503 animals) and rats (18,586 animals). Fish accounted for about 23% (30,766 animals) of the total use. There has been a continuous slight decrease in the use of rats and rabbits from year to year since 2008. The increased numbers of cats (454 animals) and dogs (2,805 animals) resulted from the research projects studying the genetic diseases of these species with blood samplings from pet animals. Besides these projects, 51 dogs and 0 cats and were used in experiments.

As in previous years, a major part of the animals (75%) were used for biological studies of a fundamental nature or for research and development of human and veterinary medicine (20%).

The most important human diseases studied in Finland with animals were the nervous and mental disorders, indicating the major role of research groups in universities and private sector focusing on this research area.

The use for toxicological and other safety evaluations was 1% of the total use, rats and fish being the species used. The use of animals for education and training was also minimal, 1% of the total number of animals used.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 73503 || 50985 || 21512 || 32 || 974 ||

1.b. || Rats (Rattus norvegicus) || 18586 || 5208 || 12680 || || 698 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 11 || || 11 || || ||

1.d. || Hamsters (Mesocricetus ) || 201 || 30 || 28 || || 143 ||

1.e. || Other Rodents (other Rodentia) || 2682 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 357 || 96 || 261 || || || 28

1.g. || Cats (Felis catus) || 454 || 454 || || || ||

1.h. || Dogs (Canis familiaris) || 2805 || 2755 || 50 || || || 16

1.i. || Ferrets (Mustela putorius furo) || 0 || || || || ||

1.j. || Other Carnivores (other Carnivora) || 656 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 23 || || || || ||

1.l. || Pigs (Sus) || 681 || || || || ||

1.m. || Goats (Capra) || 40 || || || || ||

1.n. || Sheep (Ovis) || 684 || || || || ||

1.o. || Cattle (Bos) || 63 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || || || || ||

1.q. || New World Monkeys (Ceboidea) || 0 || || || || ||

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || ||

1.s. || Apes (Hominoidea) || 0 || || || || ||

1.t. || Other Mammals (other Mammalia) || 17 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || || || || ||

1.v. || Other birds (other Aves) || 4426 || || || || ||

1.w. || Reptiles (Reptilia) || 15 || || || || ||

1.x. || Amphibians (Amphibia) || 73 || || || || ||

1.y. || Fish (Pisces) || 30766 || || || || ||

1.z. || TOTAL || 136043 || 59528 || 34542 || 32 || 1815 || 44

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 55762 || 16869 || || || 81 || 40 || 711 || 40 || 73503

2.b. || Rats || 8172 || 9438 || || || 479 || || 497 || || 18586

2.c. || Guinea-Pigs || 11 || || || || || || || || 11

2.d. || Hamsters || 60 || 141 || || || || || || || 201

2.e. || Other Rodents || 2680 || || || || || || 2 || || 2682

2.f. || Rabbits || 205 || 109 || || || 31 || 12 || || || 357

2.g. || Cats || 454 || || || || || || || || 454

2.h. || Dogs || 2753 || 24 || || || 28 || || || || 2805

2.i. || Ferrets || || || || || || || || || 0

2.j. || Other Carnivores || 656 || || || || || || || || 656

2.k. || Horses, donkeys and cross breds || 22 || || || || || || 1 || || 23

2.l. || Pigs || 214 || 83 || 210 || || || 15 || 79 || 80 || 681

2.m. || Goats || 40 || || || || || || || || 40

2.n. || Sheep || 13 || || 650 || || || 20 || 1 || || 684

2.o. || Cattle || 25 || 12 || || 24 || || 1 || 1 || || 63

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || || || || || || || || || 0

2.r. || Old World Monkeys || || || || || || || || || 0

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || 17 || || || || || || || || 17

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || 912 || 9 || || 3095 || || 8 || 18 || 384 || 4426

2.w. || Reptiles || 15 || || || || || || || || 15

2.x. || Amphibians || 73 || || || || || || || || 73

2.y. || Fish || 29894 || || || || 720 || || 152 || || 30766

2.z. || TOTAL || 101978 || 26685 || 860 || 3119 || 1339 || 96 || 1462 || 504 || 136043

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 81 || || || || || || || || || 81

3.b. || Rats || 261 || || 140 || || || || || || 78 || 479

3.c. || Guinea-Pigs || || || || || || || || || || 0

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 31 || || || || || || || || || 31

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || 28 || || || || || || || || || 28

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || || || 0

3.y. || Fish || || || || || || || || 720 || || 720

3.z. || TOTAL || 401 || 0 || 140 || 0 || 0 || 0 || 0 || 720 || 78 || 1339

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 7268 || 20901 || 5422 || 7391 || || 40982

4.b. || Rats || 1555 || 10484 || 1409 || 1353 || || 14801

4.c. || Guinea-Pigs || || || || || || 0

4.d. || Hamsters || || || 143 || || || 143

4.e. || Other Rodents || || || || || || 0

4.f. || Rabbits || 121 || || || 145 || || 266

4.g. || Cats || || || || || 454 || 454

4.h. || Dogs || 22 || || 2 || || 2753 || 2777

4.i. || Ferrets || || || || || || 0

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || || 0

4.l. || Pigs || 284 || || || 20 || || 304

4.m. || Goats || || || || || || 0

4.n. || Sheep || 1 || || || 29 || || 30

4.o. || Cattle || || || || || 67 || 67

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || || || 0

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || 2 || 17 || 19

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || || || || || || 0

4.y. || Fish || || || || 8960 || || 8960

4.z. || TOTAL || 9251 || 31385 || 6976 || 17900 || 3291 || 68803

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || || || 0 ||

5.b. || Rats || || || || || || || 0 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || || || || || || 0 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || 210 || 210 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || 650 || 650 ||

5.o. || Cattle || 24 || || || || || || 24 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || 3095 || 3095 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 24 || 0 || 0 || 0 || 0 || 3955 || 3979 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || 6 || || || || 75 || 81 ||

6.b. || Rats || 261 || 140 || || || || 78 || 479 ||

6.c. || Guinea-Pigs || || || || || || || 0 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || 3 || || || || 28 || 31 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || 28 || || || || || || 28 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || || || 0 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || || || || || || 0 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || || 0 ||

6.y. || Fish || || || || || || 720 || 720 ||

6.z. || TOTAL || 289 || 149 || 0 || 0 || 0 || 901 || 1339 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || || 6 || 75 || || || || || || || || || || || 81

7.b. || Rats || || || 293 || || || || || || 100 || || || || 86 || 479

7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || 3 || || || 28 || || || || || || || || 31

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || 28 || || || || || || || || || || || 28

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || || || || || || || || || || || || 0

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || || || || || || 0

7.y. || Fish || || || || || || || 90 || || || || 630 || || || 720

7.z. || TOTAL || 0 || 6 || 399 || 0 || 0 || 28 || 90 || 0 || 100 || 0 || 630 || 0 || 86 || 1339

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 6 || 347 || || || 28 || || || || || || || 20 || 401

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || 40 || || || || || || 100 || || || || || 140

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || 90 || || || || 630 || || || 720

8.i. || Other toxicological or safety evaluations || || || 12 || || || || || || || || || || 66 || 78

8.j. || TOTAL || 0 || 6 || 399 || 0 || 0 || 28 || 90 || 0 || 100 || 0 || 630 || 0 || 86 || 1339

SWEDEN

Statistical data submitted

The statistical data were submitted by the Board of Agriculture.

Comments of Swedish authorities

According to the EU definition (Directive 86/609/EEC), the number of laboratory animals used during 2011 in Sweden was 296,684 including reused animals and 271,041 excluding reused animals. This is a decrease compared to the 501,499 animals (including reused animals) reported for 2008 mostly explained by the fact that tagged fish are no longer, starting 2009, included in these statistics. During 2011, the number of fish used for this purpose was 120,500. Apart from that, the figures for 2011 also reflect well the minor fluctuation that has been seen during the last 5 years in the number of laboratory animals used in Sweden.

From 1990 until 2002, the mean number of laboratory animals used in Sweden was about 315,000 with the highest number 1994 (approximately 351,000) and the lowest 1997 (approximately 267,000). From 2003-2008, however, there has been an increase in the number of animals used due to the fact that tagging of fish for assessment studies have been included. Apart from fish, mice and rats are the animals predominately used in animal experimentation in Sweden. During the last 10 years the trend has been an increase in the use of mice whereas the use of rats, rabbits and guinea pigs has decreased. The increased use of mice as laboratory animals is most probably due to the increased use of transgenic technique(s).

Specific use of animals

As in previous years, most laboratory animals used during 2011 were used for fundamental biological research.

Only 3.5% of the animals were used in toxicological research, and the most common animals used in toxicological research were rats, mice and fish.

Swedish definition

According to Swedish legislation, all use of animals with a scientific purpose is defined as animal experimentation. Sweden therefore also collects statistical data on for example animals used in behaviour studies, feeding trials and animals being killed for the use of their tissues and organs. During 2011, 412,629 animals were reported being used for these purposes. In addition, Sweden also keeps statistical records of fish used in assessment studies. In this category, during 2011 approximately 7,734,200 fish were caught by trawling or netting, whereas 120,500 fish were tagged.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 185913 || 136491 || 46206 || || 3216 ||

1.b. || Rats (Rattus norvegicus) || 35202 || 7559 || 27545 || || 98 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 1151 || 747 || 404 || || ||

1.d. || Hamsters (Mesocricetus ) || 881 || 0 || 881 || || ||

1.e. || Other Rodents (other Rodentia) || 1483 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 710 || 675 || 35 || 0 || || 6

1.g. || Cats (Felis catus) || 34 || 0 || 0 || 34 || || 0

1.h. || Dogs (Canis familiaris) || 530 || 447 || 33 || 2 || 48 || 133

1.i. || Ferrets (Mustela putorius furo) || 76 || 76 || 0 || 0 || || 0

1.j. || Other Carnivores (other Carnivora) || 256 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 107 || || || || ||

1.l. || Pigs (Sus) || 2277 || || || || ||

1.m. || Goats (Capra) || 13 || || || || ||

1.n. || Sheep (Ovis) || 285 || || || || ||

1.o. || Cattle (Bos) || 370 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0

1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 7 || 7

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 1625 || || || || ||

1.u. || Quail (Coturnix coturnix) || 0 || 0 || 0 || 0 || 0 ||

1.v. || Other birds (other Aves) || 2804 || || || || ||

1.w. || Reptiles (Reptilia) || 0 || || || || ||

1.x. || Amphibians (Amphibia) || 1216 || || || || ||

1.y. || Fish (Pisces) || 36108 || || || || ||

1.z. || TOTAL || 271041 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 129685 || 50027 || 2 || || 531 || 1008 || 567 || 4093 || 185913

2.b. || Rats || 16700 || 14564 || 6 || || 2888 || 340 || 471 || 233 || 35202

2.c. || Guinea-Pigs || 158 || 824 || || || || || 50 || 119 || 1151

2.d. || Hamsters || 14 || 758 || || || 90 || || 19 || || 881

2.e. || Other Rodents || 1483 || || || || || || || || 1483

2.f. || Rabbits || 330 || 365 || 4 || || 2 || || 3 || 6 || 710

2.g. || Cats || 20 || || || || || || || 14 || 34

2.h. || Dogs || 81 || 59 || || || 284 || 104 || 2 || || 530

2.i. || Ferrets || 76 || || || || || || 33 || || 109

2.j. || Other Carnivores || 256 || || || || || || || || 256

2.k. || Horses, donkeys and cross breds || 51 || || || || || 10 || || 13 || 74

2.l. || Pigs || 1124 || 271 || || || || 208 || 582 || 92 || 2277

2.m. || Goats || 0 || || || || || || || 13 || 13

2.n. || Sheep || 64 || || || || || || || 221 || 285

2.o. || Cattle || 9 || 74 || || || || 6 || 280 || 1 || 370

2.p. || Prosimians || 0 || || || || || || || || 0

2.q. || New World Monkeys || 0 || || || || || || || || 0

2.r. || Old World Monkeys || 0 || || || || || || || || 0

2.s. || Apes || 0 || || || || || || || || 0

2.t. || Other Mammals || 1617 || || || || || || || 8 || 1625

2.u. || Quail || 0 || || || || || || || || 0

2.v. || Other birds || 2358 || 216 || 60 || || || 130 || || 40 || 2804

2.w. || Reptiles || 0 || || || || || || || || 0

2.x. || Amphibians || 536 || || || || 680 || || || || 1216

2.y. || Fish || 10790 || || || || 9369 || 31 || 5020 || 10898 || 36108

2.z. || TOTAL || 165352 || 67158 || 72 || 0 || 13844 || 1837 || 7027 || 15751 || 271041

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 530 || || || || || || || 1 || || 531

3.b. || Rats || 2837 || || || || || || || 51 || || 2888

3.c. || Guinea-Pigs || || || || || || || || || || 0

3.d. || Hamsters || 90 || || || || || || || || || 90

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 2 || || || || || || || || || 2

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || 284 || || || || || || || || || 284

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || || || || || || || || || || 0

3.m. || Goats || || || || || || || || || || 0

3.n. || Sheep || || || || || || || || || || 0

3.o. || Cattle || || || || || || || || || || 0

3.p. || Prosimians || || || || || || || || || || 0

3.q. || New World Monkeys || || || || || || || || || || 0

3.r. || Old World Monkeys || || || || || || || || || || 0

3.s. || Apes || || || || || || || || || || 0

3.t. || Other Mammals || || || || || || || || || || 0

3.u. || Quail || || || || || || || || || || 0

3.v. || Other birds || || || || || || || || || || 0

3.w. || Reptiles || || || || || || || || || || 0

3.x. || Amphibians || || || || || || || || 680 || || 680

3.y. || Fish || 2533 || || || || || || || 5356 || 1480 || 9369

3.z. || TOTAL || 6276 || 0 || 0 || 0 || 0 || 0 || 0 || 6088 || 1480 || 13844

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 16401 || 48508 || 29123 || 79082 || 1689 || 174803

4.b. || Rats || 2991 || 17328 || 788 || 9837 || || 30944

4.c. || Guinea-Pigs || 40 || 463 || || 479 || || 982

4.d. || Hamsters || 745 || || || 27 || || 772

4.e. || Other Rodents || || || || 99 || 824 || 923

4.f. || Rabbits || 254 || 54 || 2 || 389 || || 699

4.g. || Cats || || 20 || || || || 20

4.h. || Dogs || 54 || || || 5 || 185 || 244

4.i. || Ferrets || || 76 || || || || 76

4.j. || Other Carnivores || || || || || || 0

4.k. || Horses, donkeys and cross breds || || || || || 61 || 61

4.l. || Pigs || 416 || 8 || 1 || 559 || 271 || 1255

4.m. || Goats || || || || || || 0

4.n. || Sheep || 37 || || || 27 || 80 || 144

4.o. || Cattle || || || || || || 0

4.p. || Prosimians || || || || || || 0

4.q. || New World Monkeys || || || || || || 0

4.r. || Old World Monkeys || || || || || || 0

4.s. || Apes || || || || || || 0

4.t. || Other Mammals || || || || 20 || || 20

4.u. || Quail || || || || || || 0

4.v. || Other birds || || || || 1015 || 1318 || 2333

4.w. || Reptiles || || || || || || 0

4.x. || Amphibians || 75 || 31 || || 430 || || 536

4.y. || Fish || 0 || || 274 || 60 || 1378 || 1712

4.z. || TOTAL || 21013 || 66488 || 30188 || 92029 || 5806 || 215524

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || || 2 || 2 ||

5.b. || Rats || || || || || || 6 || 6 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || 4 || || || || || || 4 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || 60 || 60 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 4 || 0 || 0 || 0 || 0 || 68 || 72 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || || || || || 530 || 1 || 531 ||

6.b. || Rats || || || || || 2837 || 51 || 2888 ||

6.c. || Guinea-Pigs || || || || || || || 0 ||

6.d. || Hamsters || || || || || 90 || || 90 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || || || || 2 || || 2 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || 284 || || 284 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || || || 0 ||

6.m. || Goats || || || || || || || 0 ||

6.n. || Sheep || || || || || || || 0 ||

6.o. || Cattle || || || || || || || 0 ||

6.p. || Prosimians || || || || || || || 0 ||

6.q. || New World Monkeys || || || || || || || 0 ||

6.r. || Old World Monkeys || || || || || || || 0 ||

6.s. || Apes || || || || || || || 0 ||

6.t. || Other Mammals || || || || || || || 0 ||

6.u. || Quail || || || || || || || 0 ||

6.v. || Other birds || || || || || || || 0 ||

6.w. || Reptiles || || || || || || || 0 ||

6.x. || Amphibians || || || || || || 680 || 680 ||

6.y. || Fish || 651 || || || || 1508 || 7210 || 9369 ||

6.z. || TOTAL || 651 || 0 || 0 || 0 || 5251 || 7942 || 13844 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || || || || 196 || || || || 200 || || 1 || || || || 134 || 531

7.b. || Rats || || || 1099 || || || || 463 || || 184 || 448 || 75 || || 619 || 2888

7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0

7.d. || Hamsters || || || 80 || || || || || || || || || || 10 || 90

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || || || || || || || || || || || 2 || 2

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || 74 || || || || 207 || || || || || || || 281

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || 3 || 3

7.l. || Pigs || || || || || || || || || || || || || || 0

7.m. || Goats || || || || || || || || || || || || || || 0

7.n. || Sheep || || || || || || || || || || || || || || 0

7.o. || Cattle || || || || || || || || || || || || || || 0

7.p. || Prosimians || || || || || || || || || || || || || || 0

7.q. || New World Monkeys || || || || || || || || || || || || || || 0

7.r. || Old World Monkeys || || || || || || || || || || || || || || 0

7.s. || Apes || || || || || || || || || || || || || || 0

7.t. || Other Mammals || || || || || || || || || || || || || || 0

7.u. || Quail || || || || || || || || || || || || || || 0

7.v. || Other birds || || || || || || || || || || || || || || 0

7.w. || Reptiles || || || || || || || || || || || || || || 0

7.x. || Amphibians || || || || || || || || || 500 || || || 180 || || 680

7.y. || Fish || || 28 || || || || || || || 4798 || || 1969 || 2574 || || 9369

7.z. || TOTAL || 0 || 28 || 1449 || 0 || 0 || 0 || 870 || 0 || 5483 || 448 || 2044 || 2754 || 768 || 13844

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 28 || 1449 || || || || 819 || || 1529 || 448 || 1235 || || 768 || 6276

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0

8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || 51 || || 3954 || || 809 || 1274 || || 6088

8.i. || Other toxicological or safety evaluations || || || || || || || || || || || || 1480 || || 1480

8.j. || TOTAL || 0 || 28 || 1449 || 0 || 0 || 0 || 870 || 0 || 5483 || 448 || 2044 || 2754 || 768 || 13844

UNITED KINGDOM

Statistical data submitted

The United Kingdom statistical data for 2011 were prepared, quality assured and submitted by the Home Office.

Within the United Kingdom (UK), Great Britain (GB) and Northern Ireland (NI) publish separate, annual statistical reports based largely on the number of procedures started rather than numbers of animals used. The 2011 data collection process was 100% complete.

In accord with our established practice the UK figures presented here have been recompiled from the original data in terms of animal numbers for the classes of animal use recorded in the EU statistical tables. It should be noted that the UK also regulates, and the UK domestic statistical reports enumerate, animals bred for the maintenance of colonies of genetically modified or harmful mutant animals, and that category of animal use largely accounts for the differences in the figures in the original GB & NI publications and those in this EU report.

Comments of United Kingdom authorities

In the UK, just over 2.05 million animals were used for the first time in procedures started in 2011, a fall of 216,426 (-10%) on the number reported for 2008. The decrease was largely accounted for by decreases in numbers of rats (-90,852), fish (-63,730), mice (-56,323) and guinea pigs (-17,736) along with an increase in the use of other birds  (+37,775).

1,828,672 (89%) of the animals used (2,050,458) were mice (56%), fish (20%) or rats (12%).

Cold-blooded animals (fish, amphibia, and reptiles) accounted for 425,240  (21%) of the animals used.

Cats, dogs, equidae and non-human primates are accorded special protection in the UK and collectively amounted to 4,877 animals, 0.2% of the animals used, a reduction of 3228 (-40%) compared with 2008.

Non-human primates accounted for 1,459 animals, 0.07% of animals used, a decrease of 1895 animals (-56%) compared with 2008 (there was a fall in the numbers of new world monkeys and old world monkeys used).

1,425,640 animals (70%) were used for fundamental biological studies, research and development and production and quality control relating to human medicine, dentistry and veterinary medicine.

Toxicological or other safety evaluation used 229,674 animals (11%), a decrease of 55,214 since 2008.

There was a decrease in the number of toxicology and other safety evaluation experiments carried out in 2011 not to satisfy any regulatory requirements (45,546), down 48,639 compared with 2008, largely due to decreases in such use of fish (-47,084).

146,505 animals (7%) were used for the production and quality control of products and devices for human medicine, dentistry or veterinary medicine, 29,857 less than in 2008. This decrease was accounted for by a decrease in the number of mice (-16,669) and fish (-15,393).

Approximately 43% of animals used received some form of anaesthesia, compared to approximately 40% in 2008 (for the other animals the use of anaesthesia would have been deemed to increase the severity of the procedure.

As in 2008 no animals were used in 2011 to evaluate the safety of either cosmetic products or cosmetic ingredients.

No animals were used in 2011 for monoclonal antibody production using the ascites method.

TABLE 1:      NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN

Origin versus species

1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals

1.a. || Mice (Mus musculus) || 1155920 || 1143119 || 5171 || 33 || 7597 ||

1.b. || Rats (Rattus norvegicus) || 252437 || 251420 || 593 || 1 || 423 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 11514 || 7788 || 3726 || 0 || 0 ||

1.d. || Hamsters (Mesocricetus ) || 2003 || 1546 || 457 || 0 || 0 ||

1.e. || Other Rodents (other Rodentia) || 3243 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 11920 || 11049 || 799 || 0 || 72 || 2042

1.g. || Cats (Felis catus) || 172 || 62 || 97 || 0 || 13 || 75

1.h. || Dogs (Canis familiaris) || 2872 || 2205 || 375 || 0 || 292 || 731

1.i. || Ferrets (Mustela putorius furo) || 552 || 552 || 0 || 0 || 0 || 139

1.j. || Other Carnivores (other Carnivora) || 742 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 374 || || || || ||

1.l. || Pigs (Sus) || 4370 || || || || ||

1.m. || Goats (Capra) || 117 || || || || ||

1.n. || Sheep (Ovis) || 9556 || || || || ||

1.o. || Cattle (Bos) || 4310 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 244 || 244 || 0 || 0 || 0 || 103

1.r. || Old World Monkeys (Cercopithecoidea) || 1215 || 340 || 48 || 0 || 827 || 375

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals(other Mammalia) || 771 || || || || ||

1.u. || Quail (Coturnix coturnix) || 34 || 34 || 0 || 0 || 0 ||

1.v. || Other birds (other Aves) || 162852 || || || || ||

1.w. || Reptiles (Reptilia) || 383 || || || || ||

1.x. || Amphibians (Amphibia) || 4542 || || || || ||

1.y. || Fish (Pisces) || 420315 || || || || ||

1.z. || TOTAL || 2050458 || || || || ||

Note 1:       Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

Note 2:       Only the white boxes need to be completed.

Note 3:       The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

TABLE 2:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total

2.a. || Mice || 684033 || 86787 || 99881 || 12961 || 54212 || 4493 || 903 || 212650 || 1155920

2.b. || Rats || 79959 || 55152 || 3005 || 0 || 99255 || 6 || 1165 || 13895 || 252437

2.c. || Guinea-Pigs || 2283 || 1567 || 4354 || 1112 || 1274 || 94 || 100 || 730 || 11514

2.d. || Hamsters || 883 || 222 || 0 || 118 || 470 || 0 || 0 || 310 || 2003

2.e. || Other Rodents || 2316 || 214 || 0 || 0 || 230 || 0 || 0 || 483 || 3243

2.f. || Rabbits || 1174 || 427 || 1744 || 1520 || 5287 || 1402 || 14 || 352 || 11920

2.g. || Cats || 125 || 13 || 0 || 0 || 23 || 0 || 0 || 11 || 172

2.h. || Dogs || 125 || 158 || 65 || 25 || 2421 || 0 || 0 || 78 || 2872

2.i. || Ferrets || 285 || 0 || 24 || 4 || 0 || 9 || 13 || 217 || 552

2.j. || Other Carnivores || 557 || 0 || 0 || 19 || 0 || 0 || 0 || 166 || 742

2.k. || Horses, donkeys and cross breds || 67 || 23 || 0 || 46 || 50 || 36 || 0 || 152 || 374

2.l. || Pigs || 1404 || 170 || 24 || 910 || 852 || 0 || 0 || 1010 || 4370

2.m. || Goats || 33 || 0 || 3 || 3 || 6 || 69 || 0 || 3 || 117

2.n. || Sheep || 6059 || 48 || 412 || 398 || 161 || 1204 || 0 || 1274 || 9556

2.o. || Cattle || 2497 || 220 || 0 || 967 || 102 || 120 || 0 || 404 || 4310

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 125 || 0 || 79 || 0 || 27 || 0 || 0 || 13 || 244

2.r. || Old World Monkeys || 77 || 85 || 17 || 0 || 994 || 0 || 0 || 42 || 1215

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 751 || 0 || 0 || 0 || 0 || 0 || 0 || 20 || 771

2.u. || Quail || 34 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 34

2.v. || Other birds || 14559 || 30 || 59 || 10778 || 4945 || 1873 || 0 || 130608 || 162852

2.w. || Reptiles || 383 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 383

2.x. || Amphibians || 4086 || 0 || 0 || 0 || 419 || 0 || 0 || 37 || 4542

2.y. || Fish || 330979 || 1225 || 0 || 7977 || 58946 || 0 || 0 || 21188 || 420315

2.z. || TOTAL || 1132794 || 146341 || 109667 || 36838 || 229674 || 9306 || 2195 || 383643 || 2050458

TABLE 3:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Products versus species

3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total

3.a. || Mice || 32882 || 5789 || 5364 || 0 || 0 || 0 || 0 || 0 || 10177 || 54212

3.b. || Rats || 64995 || 12431 || 12433 || 0 || 0 || 0 || 0 || 704 || 8692 || 99255

3.c. || Guinea-Pigs || 1260 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 14 || 1274

3.d. || Hamsters || 390 || 0 || 80 || 0 || 0 || 0 || 0 || 0 || 0 || 470

3.e. || Other Rodents || 0 || 48 || 0 || 0 || 0 || 0 || 0 || 0 || 182 || 230

3.f. || Rabbits || 3511 || 1008 || 646 || 0 || 0 || 0 || 0 || 0 || 122 || 5287

3.g. || Cats || 23 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 23

3.h. || Dogs || 2224 || 65 || 0 || 0 || 0 || 0 || 0 || 0 || 132 || 2421

3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.k. || Horses, donkeys and cross breds || 50 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 50

3.l. || Pigs || 451 || 5 || 0 || 0 || 0 || 0 || 0 || 0 || 396 || 852

3.m. || Goats || 0 || 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6

3.n. || Sheep || 145 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 16 || 161

3.o. || Cattle || 83 || 19 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 102

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 27 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 27

3.r. || Old World Monkeys || 775 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 219 || 994

3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.v. || Other birds || 3184 || 1433 || 0 || 0 || 0 || 0 || 0 || 64 || 264 || 4945

3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 400 || 19 || 419

3.y. || Fish || 44796 || 1965 || 668 || 0 || 0 || 0 || 0 || 11205 || 312 || 58946

3.z. || TOTAL || 154796 || 22769 || 19191 || 0 || 0 || 0 || 0 || 12373 || 20545 || 229674

TABLE 4:      NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES

Main categories versus species

4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total

4.a. || Mice || 49326 || 133047 || 165534 || 652881 || 15108 || 1015896

4.b. || Rats || 12368 || 63367 || 3205 || 137521 || 121 || 216582

4.c. || Guinea-Pigs || 666 || 280 || 0 || 9234 || 1112 || 11292

4.d. || Hamsters || 0 || 32 || 32 || 1606 || 127 || 1797

4.e. || Other Rodents || 1696 || 124 || 0 || 710 || 60 || 2590

4.f. || Rabbits || 820 || 226 || 0 || 7494 || 1599 || 10139

4.g. || Cats || 0 || 6 || 0 || 119 || 47 || 172

4.h. || Dogs || 93 || 0 || 0 || 2364 || 262 || 2719

4.i. || Ferrets || 0 || 38 || 0 || 497 || 4 || 539

4.j. || Other Carnivores || 19 || 0 || 0 || 538 || 23 || 580

4.k. || Horses, donkeys and cross breds || 1 || 0 || 0 || 102 || 271 || 374

4.l. || Pigs || 222 || 104 || 6 || 1946 || 2060 || 4338

4.m. || Goats || 10 || 0 || 0 || 95 || 5 || 110

4.n. || Sheep || 92 || 30 || 0 || 8081 || 1056 || 9259

4.o. || Cattle || 14 || 0 || 0 || 2603 || 1677 || 4294

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 8 || 79 || 0 || 157 || 0 || 244

4.r. || Old World Monkeys || 10 || 22 || 0 || 977 || 0 || 1009

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 13 || 0 || 738 || 20 || 771

4.u. || Quail || 0 || 0 || 0 || 34 || 0 || 34

4.v. || Other birds || 929 || 1617 || 0 || 13945 || 143157 || 159648

4.w. || Reptiles || 0 || 0 || 0 || 383 || 0 || 383

4.x. || Amphibians || 0 || 29 || 80 || 3977 || 0 || 4086

4.y. || Fish || 108 || 12363 || 5692 || 314547 || 19975 || 352685

4.z. || TOTAL || 66382 || 211377 || 174549 || 1160549 || 186684 || 1799541

TABLE 5:      NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || 190 || 3843 || 0 || 359 || 107628 || 822 || 112842 ||

5.b. || Rats || 77 || 680 || 0 || 0 || 2147 || 101 || 3005 ||

5.c. || Guinea-Pigs || 120 || 541 || 0 || 199 || 4606 || 0 || 5466 ||

5.d. || Hamsters || 0 || 118 || 0 || 0 || 0 || 0 || 118 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 0 || 0 || 0 || 0 || 3254 || 10 || 3264 ||

5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.h. || Dogs || 0 || 0 || 0 || 0 || 90 || 0 || 90 ||

5.i. || Ferrets || 0 || 0 || 0 || 0 || 28 || 0 || 28 ||

5.j. || Other Carnivores || 19 || 0 || 0 || 0 || 0 || 0 || 19 ||

5.k. || Horses, donkeys and cross breds || 0 || 40 || 0 || 0 || 6 || 0 || 46 ||

5.l. || Pigs || 26 || 393 || 0 || 0 || 515 || 0 || 934 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 6 || 0 || 6 ||

5.n. || Sheep || 52 || 141 || 0 || 4 || 613 || 0 || 810 ||

5.o. || Cattle || 0 || 562 || 0 || 0 || 405 || 0 || 967 ||

5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 79 || 0 || 79 ||

5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 17 || 0 || 17 ||

5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.v. || Other birds || 944 || 437 || 0 || 0 || 9456 || 0 || 10837 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 0 || 3296 || 0 || 0 || 0 || 4681 || 7977 ||

5.z. || TOTAL || 1428 || 10051 || 0 || 562 || 128850 || 5614 || 146505 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

|| 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 6:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Regulatory requirements versus species

6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total ||

6.a. || Mice || 39 || 4181 || 46 || 221 || 47335 || 2390 || 54212 ||

6.b. || Rats || 170 || 220 || 0 || 272 || 95038 || 3555 || 99255 ||

6.c. || Guinea-Pigs || 4 || 58 || 0 || 22 || 1054 || 136 || 1274 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 470 || 0 || 470 ||

6.e. || Other Rodents || 4 || 0 || 0 || 0 || 191 || 35 || 230 ||

6.f. || Rabbits || 0 || 1051 || 0 || 36 || 3977 || 223 || 5287 ||

6.g. || Cats || 0 || 15 || 0 || 0 || 8 || 0 || 23 ||

6.h. || Dogs || 0 || 35 || 0 || 0 || 2293 || 93 || 2421 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.k. || Horses, donkeys and cross breds || 0 || 32 || 0 || 0 || 18 || 0 || 50 ||

6.l. || Pigs || 2 || 389 || 0 || 38 || 423 || 0 || 852 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 6 || 0 || 6 ||

6.n. || Sheep || 0 || 20 || 0 || 69 || 72 || 0 || 161 ||

6.o. || Cattle || 0 || 8 || 0 || 0 || 94 || 0 || 102 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 14 || 13 || 27 ||

6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 987 || 7 || 994 ||

6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.v. || Other birds || 591 || 1844 || 0 || 0 || 2246 || 264 || 4945 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 419 || 0 || 419 ||

6.y. || Fish || 858 || 7994 || 0 || 1137 || 10127 || 38830 || 58946 ||

6.z. || TOTAL || 1668 || 15847 || 46 || 1795 || 164772 || 45546 || 229674 ||

Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

|| 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol.

|| 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an

|| 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be

|| 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium.

Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

|| 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine

TABLE 7:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus species

7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total

|| || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

7.a. || Mice || 1180 || 4443 || 7857 || 0 || 1306 || 0 || 1945 || 1806 || 355 || 2166 || 156 || 0 || 32998 || 54212

7.b. || Rats || 1948 || 3203 || 27072 || 0 || 0 || 0 || 10847 || 2032 || 2987 || 4766 || 34214 || 0 || 12186 || 99255

7.c. || Guinea-Pigs || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1152 || 1274

7.d. || Hamsters || 0 || 0 || 40 || 0 || 0 || 0 || 96 || 0 || 0 || 0 || 0 || 0 || 334 || 470

7.e. || Other Rodents || 182 || 4 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 44 || 230

7.f. || Rabbits || 0 || 0 || 178 || 987 || 0 || 692 || 45 || 0 || 1795 || 0 || 162 || 0 || 1428 || 5287

7.g. || Cats || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 21 || 23

7.h. || Dogs || 0 || 0 || 1244 || 0 || 0 || 0 || 840 || 0 || 0 || 0 || 95 || 0 || 242 || 2421

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.k. || Horses, donkeys and cross breds || 0 || 0 || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 18 || 50

7.l. || Pigs || 0 || 0 || 124 || 8 || 0 || 0 || 104 || 0 || 0 || 0 || 0 || 0 || 616 || 852

7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 6

7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 0 || 0 || 0 || 0 || 0 || 131 || 161

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 102 || 102

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 13 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 14 || 27

7.r. || Old World Monkeys || 0 || 0 || 539 || 0 || 0 || 0 || 228 || 0 || 0 || 0 || 0 || 0 || 227 || 994

7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.v. || Other birds || 368 || 182 || 594 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 556 || 0 || 3245 || 4945

7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.x. || Amphibians || 0 || 0 || 400 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 19 || 419

7.y. || Fish || 5488 || 2228 || 8870 || 0 || 0 || 0 || 4032 || 0 || 0 || 0 || 1280 || 0 || 37048 || 58946

7.z. || TOTAL || 9288 || 10060 || 46965 || 995 || 1306 || 692 || 18167 || 3838 || 5137 || 6932 || 36463 || 0 || 89831 || 229674

TABLE 8:      NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS

Types of tests versus products

8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total

|| || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || ||

8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 122 || 1616 || 35252 || 181 || 308 || 8 || 14003 || 2502 || 4520 || 5285 || 22153 || 0 || 68846 || 154796

8.b. || Products/substances used or intended to be used mainly in agriculture || 1865 || 3105 || 3980 || 518 || 40 || 414 || 1629 || 1336 || 433 || 0 || 2785 || 0 || 6664 || 22769

8.c. || Products/substances used or intended to be used mainly in industry || 511 || 802 || 3183 || 292 || 898 || 266 || 771 || 0 || 88 || 1299 || 7515 || 0 || 3566 || 19191

8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 4224 || 1147 || 4294 || 0 || 0 || 0 || 540 || 0 || 0 || 0 || 1384 || 0 || 784 || 12373

8.i. || Other toxicological or safety evaluations || 2566 || 3390 || 256 || 4 || 60 || 4 || 1224 || 0 || 96 || 348 || 2626 || 0 || 9971 || 20545

8.j. || TOTAL || 9288 || 10060 || 46965 || 995 || 1306 || 692 || 18167 || 3838 || 5137 || 6932 || 36463 || 0 || 89831 || 229674

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