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 requiremen