EN EN EN EN EN EUROPEAN COMMISSION Brussels, 30.9.2010 SEC(2010) 1107 final VOL B - Part I ([II], [III]) COMMISSION STAFF WORKING DOCUMENT DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union COM(2010) 511 final EN 2 EN Important notice This is a document of the Commission services and cannot be considered binding to this institution in any way. EN 3 EN VOL B - Part I: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES EN 4 EN TABLE OF CONTENTS BELGIUM.................................................................................................................................. 5 BULGARIA ............................................................................................................................. 20 CZECH REPUBLIC ................................................................................................................ 30 DENMARK.............................................................................................................................. 39 GERMANY.............................................................................................................................. 48 ESTONIA................................................................................................................................. 58 IRELAND ................................................................................................................................ 67 GREECE .................................................................................................................................. 76 SPAIN ...................................................................................................................................... 86 EN 5 EN BELGIUM Statistical data submitted The statistical data have been submitted by the “SPF Santé Publique, Sécurité de la Chaine Alimentaire et Environnement” (Federal Public Service of Public Health, Food Chain Safety and Environment). Comments of the Belgian authorities 1. LABORATORIES Every year, all laboratories in Belgium that use animals for experimental purposes must provide statistical information on the number of animals used the previous year. In 2008, 389 laboratories were approved as regards the use of animals for experimental purposes and they all provided their statistical data. A quarter of these laboratories had not used any animals for experimental purposes in 2008. 2. NUMBER OF ANIMALS USED IN EXPERIMENTS In all 725370 animals were used. Rodents and rabbits accounted for 93%, fish, reptiles and amphibians for 4% and birds for 2% of the total number of animals used. Dogs, cats and primates accounted respectively for 0,10%, 0,01% and 0,005% of the animals used in 2008 (Figure 1: Breakdown of species used in experiments) Rongeurs - Knaagdieren 87% Primates - Apen 0,005% Animaux agricoles Landbouw dieren 0,58% Oiseaux - Vogels 2% Chiens/Chats - Honden/Katten 0,12% Autres animaux à sang chaud - Andere w armbloed dieren 0,07% Lapins - Konijnen 6% Animaux à sang froid Koudbloed dieren 4% Figure 1: Breakdown of species used in experiments EN 6 EN A comparison of the absolute figures for 2008 with those for 2007 (Table 1: Trend in the number of animals used in experiments) shows an overall decrease of 54,490 animals (-7%). This decrease concerns mainly rodents (-53,454; -8%) and fish (-12,489; -31%). However, for some species there has been a marked increase. These are rabbits (+7,301; +21%), mainly used in certain therapeutic polyclonal antibody development programmes, and birds (+4,622; +36%) which were used in 2008 for food tests on poultry. The number of monkeys remained stable and limited in 2008 (41 animals) and in 2007 (38 animals). These primates are used for vaccine quality control tests and for studies of human diseases (neurophysiology). EN 7 EN Table 1: Table 1: Trend in the number of animals used in experiments 2008 2007 2006 2005 2004 Mice 480.681 518.208 516.148 488.125 482.810 Rats 108.580 116.991 104.272 106.483 119.193 Guinea pigs 36.554 43.499 38.542 39.530 38.781 Hamsters 2.124 1.882 1.614 1.874 1.688 Other rodents 1.055 1.908 1.627 2.260 3.921 Rabbits 42.025 34.724 30.518 21.159 18.577 Total rodents and rabbits 671.019 717.212 692.721 659.431 664.970 Cats 78 46 107 81 184 Dogs 788 747 1.207 1.295 1.014 Ferrets 324 336 234 154 102 Other carnivores 0 0 0 0 0 Total carnivores 1.190 1.129 1.548 1.530 1.300 Horses, donkeys and cross-breeds 62 103 108 108 65 Pigs 2.969 2.657 2.022 1.876 2.272 Goats 195 122 116 157 125 Sheep 356 291 295 445 495 Cattle 657 616 758 944 982 Total ungulates 4.239 3.789 3.299 3.530 3.939 Prosimians 0 0 0 0 0 New world monkeys 0 0 0 0 7 Old world monkeys 41 38 196 449 579 Apes 0 0 0 0 0 Total primates 41 38 196 449 586 Other mammals 151 124 88 59 44 Total mammals 676.640 722.292 697.852 664.999 670.839 Quails 431 18 35 425 350 Other birds 17.151 12.942 16.127 13.266 10.492 Total birds 17.582 12.960 16.162 13.691 10.842 Reptiles 374 256 121 1.44 129 Amphibians 2.388 3477 3.516 6.177 6.362 Fish 28.386 40.875 39.064 33.965 20.574 Total cold-blooded animals 31.148 44.608 42.701 40.286 27.065 TOTAL ANIMALS 725.370 779.860 756.715 718.976 708.746 The headings in the statistical tables have remained unchanged since 1999. Taking 1999 as a reference year, figure 2 (figure 2: Trend in the number of animals used since 1999) shows that the number of animals used in Belgian laboratories has been relatively stable since then. In 2008 the figure was 8% lower than in 1999. However, the number of animals has been increasing slightly each year since 2000. This trend must be seen in the context of the high level of research in Belgium, as the increase is essentially due to the rise in the number of animals used in basic research (+34,8% between 2000 and 2008). EN 8 EN 790.089 651.504 655.217 695.091 676.564 708.746 718.976 756.715 779.860 200720062005200420032002200120001999 2008 725.370 0 100000 200000 300000 400000 500000 600000 700000 800000 900000 Figure 2: Trend in the number of animals used since 1999 3. EXPERIMENTS CARRIED OUT In descending order, animals were used mainly to research and develop products and devices used in human and veterinary medicine (32% of the animals used), in basic research studies (30%) and in tests on the production and quality control of such products and devices (30%) (Figure 3: Breakdown of the experimental fields). As regards production and quality control tests, 99% of the animals were used to comply with statutory requirements. EN 9 EN QC 30% Diagnostic - Diagnose 1% Toxicologie 3% Formation - Opleiding 3% Biol.fond. - Fund. Biol. 30% R&D 32% Autres - Overige 1% Figure 3: Breakdown of the experimental fields The following diagram (Figure 4: Breakdown of experimental fields by the animals most used) shows that of all the species, rodents are the most used. Rodents account for 82% of animals used for basic research, 94% of animals used for research and development tests on products and devices used in human and veterinary medicine and 84% of animals used for tests on the production and quality control of medical products and devices. Fish account for 11% of the animals used in basic research. Toxicology and safety tests account for 3% of the animals used in experiments in 2008; 85% of the animals used in toxicology tests were used in safety trials required by law (Figure 5: Proportion of quality control and toxicology tests imposed by law). Rodents account for 91% of all the animals used in toxicology tests. The other species used are mainly rabbits (5%) and dogs (2,8%). EN 10 EN Biologiefondamentale R&D QC Toxicologie Diagnostic Formation Autres Rongeurs OiseauxAnimaux à sang froid Lapins 0 50000 100000 150000 200000 250000 Figure 4: Breakdown of experimental fields by the animals most used 98,96% 1,04% 85,41% 14,59% 0,00% 25,00% 50,00% 75,00% 100,00% Reglem. Non/ Niet Reglem. Reglem. Non/ Niet Reglem. Qualité Contrôle / Kw aliteit Controle Toxicologie Figure 5: Proportion of quality control and toxicology tests imposed by law EN 11 EN Provenance of animals used in experiments In 2008, 89,7% of the animals used for experimental purposes came from approved suppliers in Belgium, other countries of the European Union or members of the Council of Europe and 2,9% came from establishments outside these territories. The other species of animal that are not reared solely for the purposes of agricultural experiments come from establishments that meet the current legal requirements for commercial establishments. The number of animals reused in certain experiments was 0,16% of the total number of animals used in 2008. EN 12 EN 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) 480681 141865 317570 2367 18879 1.b. Rats (Rattus norvegicus) 108580 19139 88029 116 1296 1.c. Guinea-Pigs (Cavia porcellus) 36554 4648 29865 2041 0 1.d. Hamsters (Mesocricetus ) 2124 724 289 1074 37 1.e. Other Rodents (other Rodentia) 1055 1.f. Rabbits (Oryctolagus cuniculus) 42025 38836 3189 0 0 589 1.g. Cats (Felis catus) 78 31 47 0 0 48 1.h. Dogs (Canis familiaris) 788 47 289 0 452 483 1.i. Ferrets (Mustela putorius furo) 324 0 185 0 139 0 1.j. Other Carnivores (other Carnivora) 0 1.k. Horses, donkeys and cross breds (Equidae) 62 1.l. Pigs (Sus) 2969 1.m. Goats (Capra) 195 1.n. Sheep (Ovis) 356 1.o. Cattle (Bos) 657 1.p. Prosimians (Prosimia) 0 0 0 0 0 0 1.q. New World Monkeys (Ceboidea) 0 0 0 0 0 5 1.r. Old World Monkeys (Cercopithecoidea) 41 0 12 0 29 28 1.s. Apes (Hominoidea) 0 0 0 0 0 0 1.t. Other Mammals (other Mammalia) 151 1.u. Quail (Coturnix coturnix) 431 431 0 0 0 1.v. Other birds (other Aves) 17151 1.w. Reptiles (Reptilia) 374 1.x. Amphibians (Amphibia) 2388 1.y. Fish (Pisces) 28386 1.z. TOTAL 725370 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 EN 13 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 155149 155327 138227 2445 8950 8282 10086 2215 480681 2.b. Rats 20692 59947 11668 697 12705 246 2266 359 108580 2.c. Guinea-Pigs 388 3531 29243 647 153 0 2583 9 36554 2.d. Hamsters 377 0 2 1653 30 0 62 0 2124 2.e. Other Rodents 391 660 0 0 0 0 4 0 1055 2.f. Rabbits 1441 5293 3389 30388 1213 4 251 46 42025 2.g. Cats 27 33 0 18 0 0 0 0 78 2.h. Dogs 49 38 0 18 682 1 0 0 788 2.i. Ferrets 12 312 0 0 0 0 0 0 324 2.j. Other Carnivores 0 0 0 0 0 0 0 0 0 2.k. Horses, donkeys and cross breds 25 2 0 0 0 0 35 0 62 2.l. Pigs 1309 486 0 1097 0 2 11 64 2969 2.m. Goats 53 142 0 0 0 0 0 0 195 2.n. Sheep 183 161 0 4 0 0 8 0 356 2.o. Cattle 130 85 0 374 44 0 19 5 657 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 11 0 29 0 0 1 0 0 41 2.s. Apes 0 0 0 0 0 0 0 0 0 2.t. Other Mammals 95 32 24 0 0 0 0 0 151 2.u. Quail 431 0 0 0 0 0 0 0 431 2.v. Other birds 10729 5855 0 87 0 0 0 480 17151 2.w. Reptiles 374 0 0 0 0 0 0 0 374 2.x. Amphibians 553 1500 0 0 108 0 227 0 2388 2.y. Fish 23406 265 0 0 66 0 3116 1533 28386 2.z. TOTAL 215825 233669 182582 37428 23951 8536 18668 4711 725370 EN 14 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 6754 0 0 0 0 0 0 0 2196 8950 3.b. Rats 11310 0 45 0 0 0 0 0 1350 12705 3.c. Guinea-Pigs 153 0 0 0 0 0 0 0 0 153 3.d. Hamsters 30 0 0 0 0 0 0 0 0 30 3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 3.f. Rabbits 1213 0 0 0 0 0 0 0 0 1213 3.g. Cats 0 0 0 0 0 0 0 0 0 0 3.h. Dogs 682 0 0 0 0 0 0 0 0 682 3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 3.l. Pigs 0 0 0 0 0 0 0 0 0 0 3.m. Goats 0 0 0 0 0 0 0 0 0 0 3.n. Sheep 0 0 0 0 0 0 0 0 0 0 3.o. Cattle 0 0 0 0 0 0 0 0 44 44 3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 3.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 3.s. Apes 0 0 0 0 0 0 0 0 0 0 3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 3.u. Quail 0 0 0 0 0 0 0 0 0 0 3.v. Other birds 0 0 0 0 0 0 0 0 0 0 3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 3.x. Amphibians 0 108 0 0 0 0 0 0 0 108 3.y. Fish 0 0 66 0 0 0 0 0 0 66 3.z. TOTAL 20142 108 111 0 0 0 0 0 3590 23951 EN 15 EN 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 6291 65749 42230 136336 3178 253784 4.b. Rats 1652 37145 1426 33261 106 73590 4.c. Guinea-Pigs 428 95 0 1805 67 2395 4.d. Hamsters 15 0 18 322 0 355 4.e. Other Rodents 0 640 0 320 76 1036 4.f. Rabbits 152 9 3 322 181 667 4.g. Cats 0 0 0 31 3 34 4.h. Dogs 202 0 0 56 0 258 4.i. Ferrets 0 0 0 312 12 324 4.j. Other Carnivores 0 0 0 0 0 0 4.k. Horses, donkeys and cross breds 0 0 0 0 36 36 4.l. Pigs 271 8 0 245 440 964 4.m. Goats 42 0 0 101 28 171 4.n. Sheep 145 0 0 0 3 148 4.o. Cattle 0 0 0 0 66 66 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 12 0 12 4.s. Apes 0 0 0 0 0 0 4.t. Other Mammals 3 6 5 4 61 79 4.u. Quail 0 400 0 0 0 400 4.v. Other birds 0 0 0 0 7881 7881 4.w. Reptiles 0 0 0 0 43 43 4.x. Amphibians 20 0 0 0 0 20 4.y. Fish 0 0 0 0 2111 2111 4.z. TOTAL 9221 104052 43682 173127 14292 344374 EN 16 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 0 13396 0 17081 109778 417 140672 5.b. Rats 0 752 0 2135 7635 1843 12365 5.c. Guinea-Pigs 0 1609 0 4708 23573 0 29890 5.d. Hamsters 0 579 0 0 1074 2 1655 5.e. Other Rodents 0 0 0 0 0 0 0 5.f. Rabbits 0 1960 0 1049 30766 2 33777 5.g. Cats 0 18 0 0 0 0 18 5.h. Dogs 0 18 0 0 0 0 18 5.i. Ferrets 0 0 0 0 0 0 0 5.j. Other Carnivores 0 0 0 0 0 0 0 5.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 5.l. Pigs 0 1097 0 0 0 0 1097 5.m. Goats 0 0 0 0 0 0 0 5.n. Sheep 0 4 0 0 0 0 4 5.o. Cattle 13 361 0 0 0 0 374 5.p. Prosimians 0 0 0 0 0 0 0 5.q. New World Monkeys 0 0 0 0 0 0 0 5.r. Old World Monkeys 0 0 0 0 29 0 29 5.s. Apes 0 0 0 0 0 0 0 5.t. Other Mammals 0 0 0 0 0 24 24 5.u. Quail 0 0 0 0 0 0 0 5.v. Other birds 0 87 0 0 0 0 87 5.w. Reptiles 0 0 0 0 0 0 0 5.x. Amphibians 0 0 0 0 0 0 0 5.y. Fish 0 0 0 0 0 0 0 5.z. TOTAL 13 19881 0 24973 172855 2288 220010 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 17 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 626 1113 0 0 5268 1943 8950 6.b. Rats 61 76 0 1350 9775 1443 12705 6.c. Guinea-Pigs 0 104 0 0 49 0 153 6.d. Hamsters 0 0 0 0 30 0 30 6.e. Other Rodents 0 0 0 0 0 0 0 6.f. Rabbits 0 183 0 0 1030 0 1213 6.g. Cats 0 0 0 0 0 0 0 6.h. Dogs 0 0 0 0 682 0 682 6.i. Ferrets 0 0 0 0 0 0 0 6.j. Other Carnivores 0 0 0 0 0 0 0 6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 6.l. Pigs 0 0 0 0 0 0 0 6.m. Goats 0 0 0 0 0 0 0 6.n. Sheep 0 0 0 0 0 0 0 6.o. Cattle 0 0 0 44 0 0 44 6.p. Prosimians 0 0 0 0 0 0 0 6.q. New World Monkeys 0 0 0 0 0 0 0 6.r. Old World Monkeys 0 0 0 0 0 0 0 6.s. Apes 0 0 0 0 0 0 0 6.t. Other Mammals 0 0 0 0 0 0 0 6.u. Quail 0 0 0 0 0 0 0 6.v. Other birds 0 0 0 0 0 0 0 6.w. Reptiles 0 0 0 0 0 0 0 6.x. Amphibians 0 0 0 0 0 108 108 6.y. Fish 0 0 0 66 0 0 66 6.z. TOTAL 687 1476 0 1460 16834 3494 23951 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 18 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 471 9 2068 0 0 0 553 821 0 202 1611 0 3215 8950 7.b. Rats 0 301 4533 0 0 0 1611 1428 0 1236 2151 0 1445 12705 7.c. Guinea-Pigs 0 0 27 0 104 0 0 0 0 0 0 0 22 153 7.d. Hamsters 0 0 0 0 0 0 0 0 0 0 0 0 30 30 7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.f. Rabbits 0 0 306 156 9 0 0 0 0 0 610 0 132 1213 7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.h. Dogs 0 0 409 0 0 0 82 0 0 0 0 0 191 682 7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.l. Pigs 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.o. Cattle 0 0 0 0 0 0 12 0 0 0 22 0 10 44 7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.v. Other birds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.x. Amphibians 0 0 0 0 0 0 108 0 0 0 0 0 0 108 7.y. Fish 66 0 0 0 0 0 0 0 0 0 0 0 0 66 7.z. TOTAL 537 310 7343 156 113 0 2366 2249 0 1438 4394 0 5045 23951 EN 19 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates 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 471 283 7020 156 113 0 1786 2228 0 853 4372 0 2860 20142 8.b. Products/substances used or intended to be used mainly in agriculture 0 0 0 0 0 0 108 0 0 0 0 0 0 108 8.c. Products/substances used or intended to be used mainly in industry 66 27 18 0 0 0 0 0 0 0 0 0 0 111 8.d. Products/substances used or intended to be used mainly in the household 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.i. Other toxicological or safety evaluations 0 0 305 0 0 0 472 21 0 585 22 0 2185 3590 8.j. TOTAL 537 310 7343 156 113 0 2366 2249 0 1438 4394 0 5045 23951 EN 20 EN BULGARIA Statistical data submitted The statistical data have been submitted by the National Veterinary Service. Comments of the Bulgaria authorities The National Veterinary Service (NVS) is the competent authority on animal welfare matters (AW) in Bulgaria. An organizational and implementation principle is that the AW requirements on the matters concerning animals used for experimental purposes must be performed by the 28 regional veterinary services (RVS) within the NVS. The requirements of Directive 86/609/EEC have been transposed into the national legislation, namely in Ordinance № 15 on the minimum requirements for protection and welfare of laboratory animals and the requirements to the establishments using, breeding and/or supplying such animals (in force since 01.05.2006; published in SG No. 17 of 24 February 2006) and in the Law for Veterinary Activities. In Bulgaria, experiments involving usage of live animals are carried out only where it is not possible to apply any alternative method(s) of the same purpose and result. The use of experimental animals is permitted only in establishments, that are authorized as being in compliance with the requirements laid down in Article 153 (1) of the Law on Veterinary Activity and which have official permit signed by the NVS Director-General. The NVS Director-General would issue the above mentioned permit on the basis of an ethical assessment and a positive opinion from the Animal Ethics Commission with NVS. The Animal Ethics Commission has been established as a permanently operating consultative body with the NVS Director-General. This Commission includes the following staff: 1. An official veterinary officer representing NVS; 2. A veterinarian representing the Faculties of Veterinary Medicine; 3. A physician of toxicological specialization representing Ministry of Health; 4. A scientist or researcher of biological specialization representing Bulgarian Academy of Sciences; 5. An environmental expert representing Ministry of Environment and Water; 6. A zoologist representing the Biology Faculty at Sofia University; 7. A physician representing the Medical University in Sofia; 8. Two representatives of NGOs operating in the field of AW and protection of animals; 9. A lawyer representing the Ministry of Agriculture and Food; 10. A veterinarian representing the Ministry of Agriculture and Food. The following experiments have been carried out in 2008 : -Biological studies of a fundamental nature -Research and development of products and devices for human medicine and dentistry and for veterinary medicine (R&D) - Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine (T&S evaluations) EN 21 EN - Studies and Diagnosis of Human and Animal disease (S&D of disease) - Education and training (E&T) Experiments/2008 Biological studies - 21% R&D - 35% S&D od disease - 8% E&T - 24% T&S evaluations - 12% Species use in percentage in Bulgaria Species use in percentage in Bulgaria Mice -49,9% Rats -13,85% Guinea-Pigs - 11,8% Hamsters- 0,56% Rabbits- 2,5% Cats - 0,03% Dogs - 0,05% Horses - 0,05% Pigs - 0,42% Goats - 0,25% Sheep - 0,77% Cattle - 0,39% Other birds - 4,54% Amphibians - 14,74% Fish - 0,15% The total number of animals used for experimental purposes was 32,581 in 2008 (mostly mice and hamsters). There have not been any non-human primates used for experimental purposes. Experiments not permitted in Bulgaria: 1. for educational purposes, which cause death of animals; in educational establishments animal experiments shall be replaced by other methods for visualizing the subject taught in all cases where the use of animals might be replaced by other methods and if the aim is not to provide the students with specific practical skills. 2. if the result can be achieved with any method not involving the use of live animal(s); 3. if they use stray and/or domestic dogs or cats as experimental animals. EN 22 EN 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) 16265 15820 445 1.b. Rats (Rattus norvegicus) 4513 3124 1389 1.c. Guinea-Pigs (Cavia porcellus) 3845 3807 38 1.d. Hamsters (Mesocricetus ) 182 112 70 1.e. Other Rodents (other Rodentia) 1.f. Rabbits (Oryctolagus cuniculus) 813 807 6 1.g. Cats (Felis catus) 11 11 1.h. Dogs (Canis familiaris) 15 13 2 1.i. Ferrets (Mustela putorius furo) 0 1.j. Other Carnivores (other Carnivora) 1.k. Horses, donkeys and cross breds (Equidae) 17 1.l. Pigs (Sus) 137 1.m. Goats (Capra) 80 1.n. Sheep (Ovis) 250 1.o. Cattle (Bos) 126 1.p. Prosimians (Prosimia) 0 1.q. New World Monkeys (Ceboidea) 0 1.r. Old World Monkeys (Cercopithecoidea) 0 1.s. Apes (Hominoidea) 0 1.t. Other Mammals (other Mammalia) 1.u. Quail (Coturnix coturnix) 0 1.v. Other birds (other Aves) 1477 1.w. Reptiles (Reptilia) 1.x. Amphibians (Amphibia) 4800 1.y. Fish (Pisces) 50 1.z. TOTAL 32581 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 EN 23 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 6197 108 7050 264 1964 682 16265 2.b. Rats 237 684 529 30 1080 1953 4513 2.c. Guinea-Pigs 4 634 2057 54 1000 96 3845 2.d. Hamsters 178 4 182 2.e. Other Rodents 0 2.f. Rabbits 37 24 393 60 62 13 216 8 813 2.g. Cats 5 3 4 2 14 2.h. Dogs 2 10 12 2.i. Ferrets 0 2.j. Other Carnivores 0 2.k. Horses, donkeys and cross breds 17 17 2.l. Pigs 24 10 10 93 137 2.m. Goats 20 60 80 2.n. Sheep 16 46 15 173 250 2.o. Cattle 16 110 126 2.p. Prosimians 0 2.q. New World Monkeys 0 2.r. Old World Monkeys 0 2.s. Apes 0 2.t. Other Mammals 0 2.u. Quail 0 2.v. Other birds 239 16 30 920 224 48 1477 2.w. Reptiles 0 2.x. Amphibians 200 4600 4800 2.y. Fish 50 50 2.z. TOTAL 7130 1596 10074 1341 4110 268 8054 8 32581 EN 24 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 1900 64 1964 3.b. Rats 1080 1080 3.c. Guinea-Pigs 1000 1000 3.d. Hamsters 0 3.e. Other Rodents 0 3.f. Rabbits 62 62 3.g. Cats 4 4 3.h. Dogs 0 3.i. Ferrets 0 3.j. Other Carnivores 0 3.k. Horses, donkeys and cross breds 0 3.l. Pigs 0 3.m. Goats 0 3.n. Sheep 0 3.o. Cattle 0 3.p. Prosimians 0 3.q. New World Monkeys 0 3.r. Old World Monkeys 0 3.s. Apes 0 3.t. Other Mammals 0 3.u. Quail 0 3.v. Other birds 0 3.w. Reptiles 0 3.x. Amphibians 0 3.y. Fish 0 3.z. TOTAL 4046 0 0 0 0 64 0 0 0 4110 EN 25 EN 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 480 1800 2280 4.b. Rats 40 50 85 175 4.c. Guinea-Pigs 4 4 4.d. Hamsters 100 8 108 4.e. Other Rodents 0 4.f. Rabbits 4 2 13 19 4.g. Cats 0 4.h. Dogs 0 4.i. Ferrets 0 4.j. Other Carnivores 0 4.k. Horses, donkeys and cross breds 0 4.l. Pigs 0 4.m. Goats 0 4.n. Sheep 15 15 4.o. Cattle 16 16 4.p. Prosimians 0 4.q. New World Monkeys 0 4.r. Old World Monkeys 0 4.s. Apes 0 4.t. Other Mammals 0 4.u. Quail 0 4.v. Other birds 9 254 263 4.w. Reptiles 0 4.x. Amphibians 0 4.y. Fish 0 4.z. TOTAL 48 0 630 1904 298 2880 EN 26 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 7314 7314 5.b. Rats 30 529 559 5.c. Guinea-Pigs 2054 57 2111 5.d. Hamsters 0 5.e. Other Rodents 0 5.f. Rabbits 10 443 453 5.g. Cats 5 5 5.h. Dogs 3 3 5.i. Ferrets 0 5.j. Other Carnivores 0 5.k. Horses, donkeys and cross breds 0 5.l. Pigs 10 10 20 5.m. Goats 0 5.n. Sheep 0 5.o. Cattle 0 5.p. Prosimians 0 5.q. New World Monkeys 0 5.r. Old World Monkeys 0 5.s. Apes 0 5.t. Other Mammals 0 5.u. Quail 0 5.v. Other birds 30 920 950 5.w. Reptiles 0 5.x. Amphibians 0 5.y. Fish 0 5.z. TOTAL 43 10776 0 0 0 596 11415 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 27 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 150 1700 64 50 1964 6.b. Rats 200 780 980 6.c. Guinea-Pigs 100 1000 1100 6.d. Hamsters 0 6.e. Other Rodents 0 6.f. Rabbits 60 2 62 6.g. Cats 4 4 6.h. Dogs 0 6.i. Ferrets 0 6.j. Other Carnivores 0 6.k. Horses, donkeys and cross breds 0 6.l. Pigs 0 6.m. Goats 0 6.n. Sheep 0 6.o. Cattle 0 6.p. Prosimians 0 6.q. New World Monkeys 0 6.r. Old World Monkeys 0 6.s. Apes 0 6.t. Other Mammals 0 6.u. Quail 0 6.v. Other birds 0 6.w. Reptiles 0 6.x. Amphibians 0 6.y. Fish 0 6.z. TOTAL 250 2960 70 0 0 830 4110 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 28 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 1864 100 1964 7.b. Rats 900 130 50 1080 7.c. Guinea-Pigs 1000 1000 7.d. Hamsters 0 7.e. Other Rodents 0 7.f. Rabbits 60 2 62 7.g. Cats 4 4 7.h. Dogs 0 7.i. Ferrets 0 7.j. Other Carnivores 0 7.k. Horses, donkeys and cross breds 0 7.l. Pigs 0 7.m. Goats 0 7.n. Sheep 0 7.o. Cattle 0 7.p. Prosimians 0 7.q. New World Monkeys 0 7.r. Old World Monkeys 0 7.s. Apes 0 7.t. Other Mammals 0 7.u. Quail 0 7.v. Other birds 0 7.w. Reptiles 0 7.x. Amphibians 0 7.y. Fish 0 7.z. TOTAL 3824 130 150 2 0 0 0 0 0 0 0 0 4 4110 EN 29 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates 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 3760 130 150 2 4 4046 8.b. Products/substances used or intended to be used mainly in agriculture 0 8.c. Products/substances used or intended to be used mainly in industry 0 8.d. Products/substances used or intended to be used mainly in the household 0 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 0 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 64 64 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 0 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 0 8.i. Other toxicological or safety evaluations 0 8.j. TOTAL 3824 130 150 2 0 0 0 0 0 0 0 0 4 4110 EN 30 EN CZECH REPUBLIC Statistical data submitted The statistical data have been submitted by the “Central Commission for Animal Welfare (Ústřední komise pro ochranu zvířat)”. Comments of the Czech authorities Protection of animals and animal welfare in the Czech Republic (CR) is the responsibility of the Ministry of Agriculture (Ministerstvo zemědělství). The Central Commission for Animal Welfare (Ústřední komise pro ochranu zvířat) has changed to the technical advisory board of the Minister of Agriculture. The animal welfare activities are implemented pursuant to Act No. 246/1992 Coll., on the protection of animals against cruelty, as amended. The supervision of these matters has been the responsibility of the Regional Veterinary Administrations’ inspectors in 13 regions of the CR and the Municipal Veterinary Administration in Prague. Altogether 132 inspections of experiments on animals were carried out in 2008, involving 77,694 animals. In 2 cases a penalty was imposed due to detected shortcomings. Note: The Czech tables below, which were used for calculating the EU totals in the Sixth Report, do not include animals used by the Czech Academy of Sciences (CAS) due to the death of the responsible person at the time of data collection. However, these additional animals are included in the comments below. In CAS 49,667 animals (32,995 mice, 10,106 rats, 733 guinea pigs, 56 other rodents, 299 pigs, 2,178 birds, 3,300 fish) were used and should be added to the tables provided below. Therefore, in 2008 a total of 350,380 animals were used for experimental and other scientific purposes in the CR. It should be pointed out that 40,58% of it is represented by ringed birds (142,200 birds) since pursuant to the relevant Czech legislation even bird ringing is an experiment. Of the remaining 208,180 animals used for experimental and scientific purposes only 0,02% were cats (45 cats), 0,26% dogs (552 dogs), 0,04% monkeys (80 monkeys), while no apes were used. Rodents and rabbits (62,39%, i.e. 129,887 animals) and fish (27,93%, i.e. 58,136 fish) represent the prevailing majority of animals used. In the last couple of years the number of experimental animals used in the CR was approximately the same (approximately 220,000 animals excluding ringed birds). Fluctuations in numbers, if any, are caused by experiments using fish and poultry because these experiments are usually conducted on a large group of animals (a flock in houses or stock in water reservoirs). The use of alternative methods to experiments on animals has been pushed through in the CR. Persons who manage, control and conduct experiments on animals are obliged to seek in the registers of validated alternative methods such methods which are applicable to their experiment. In the experimental project the applicant shall declare in writing that no validated alternative method can be applied for the given purpose. The training courses for persons who manage, control and conduct experiments on animals comprise also teaching of alternative methods to experiments on animals. EN 31 EN 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) 54776 51832 2888 56 1.b. Rats (Rattus norvegicus) 21531 20600 931 1.c. Guinea-Pigs (Cavia porcellus) 1902 1902 1.d. Hamsters (Mesocricetus ) 251 251 1.e. Other Rodents (other Rodentia) 1233 1.f. Rabbits (Oryctolagus cuniculus) 6304 6263 14 27 47 1.g. Cats (Felis catus) 45 15 30 1.h. Dogs (Canis familiaris) 552 478 30 44 18 1.i. Ferrets (Mustela putorius furo) 122 122 1.j. Other Carnivores (other Carnivora) 45 1.k. Horses, donkeys and cross breds (Equidae) 378 1.l. Pigs (Sus) 2013 1.m. Goats (Capra) 174 1.n. Sheep (Ovis) 1148 1.o. Cattle (Bos) 799 1.p. Prosimians (Prosimia) 0 1.q. New World Monkeys (Ceboidea) 0 1.r. Old World Monkeys (Cercopithecoidea) 80 80 59 1.s. Apes (Hominoidea) 0 1.t. Other Mammals (other Mammalia) 1774 1.u. Quail (Coturnix coturnix) 0 1.v. Other birds (other Aves) 148722 1.w. Reptiles (Reptilia) 1012 1.x. Amphibians (Amphibia) 3016 1.y. Fish (Pisces) 54836 1.z. TOTAL 300713 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 EN 32 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 14326 9138 2019 15795 703 6172 550 6073 54776 2.b. Rats 9878 4523 133 1260 3270 3 2359 105 21531 2.c. Guinea-Pigs 169 545 39 905 132 35 77 1902 2.d. Hamsters 14 180 57 251 2.e. Other Rodents 1125 83 25 1233 2.f. Rabbits 918 467 122 3533 202 217 780 65 6304 2.g. Cats 30 15 45 2.h. Dogs 44 335 18 151 2 2 552 2.i. Ferrets 118 4 122 2.j. Other Carnivores 9 36 45 2.k. Horses, donkeys and cross breds 19 30 306 13 10 378 2.l. Pigs 1146 208 468 100 8 83 2013 2.m. Goats 32 23 119 174 2.n. Sheep 108 100 250 65 625 1148 2.o. Cattle 54 29 332 4 162 184 34 799 2.p. Prosimians 0 2.q. New World Monkeys 0 2.r. Old World Monkeys 80 80 2.s. Apes 0 2.t. Other Mammals 1774 1774 2.u. Quail 0 2.v. Other birds 146422 594 506 746 54 371 29 148722 2.w. Reptiles 958 54 1012 2.x. Amphibians 2915 101 3016 2.y. Fish 16894 90 37402 300 150 54836 2.z. TOTAL 196805 16336 2313 23328 42710 7207 5048 6966 300713 EN 33 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 553 8 155 45 761 3.b. Rats 947 405 1825 54 3231 3.c. Guinea-Pigs 71 100 171 3.d. Hamsters 0 3.e. Other Rodents 0 3.f. Rabbits 142 24 60 2 12 240 3.g. Cats 0 3.h. Dogs 151 151 3.i. Ferrets 0 3.j. Other Carnivores 0 3.k. Horses, donkeys and cross breds 0 3.l. Pigs 8 100 108 3.m. Goats 0 3.n. Sheep 0 3.o. Cattle 4 4 3.p. Prosimians 0 3.q. New World Monkeys 0 3.r. Old World Monkeys 0 3.s. Apes 0 3.t. Other Mammals 210 210 3.u. Quail 0 3.v. Other birds 349 48 397 3.w. Reptiles 0 3.x. Amphibians 0 3.y. Fish 305 677 1945 549 422 523 32066 950 37437 3.z. TOTAL 2518 1384 4085 549 422 625 0 32177 950 42710 EN 34 EN 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 185 181 6411 10073 2945 19795 4.b. Rats 2629 1865 1996 1901 2803 11194 4.c. Guinea-Pigs 12 135 147 4.d. Hamsters 52 52 4.e. Other Rodents 35 35 4.f. Rabbits 134 60 118 281 593 4.g. Cats 0 4.h. Dogs 39 2 2 42 85 4.i. Ferrets 122 122 4.j. Other Carnivores 0 4.k. Horses, donkeys and cross breds 7 7 4.l. Pigs 102 3 537 642 4.m. Goats 147 147 4.n. Sheep 18 250 37 305 4.o. Cattle 114 114 4.p. Prosimians 0 4.q. New World Monkeys 0 4.r. Old World Monkeys 31 49 80 4.s. Apes 0 4.t. Other Mammals 10 10 4.u. Quail 0 4.v. Other birds 212 1641 1853 4.w. Reptiles 0 4.x. Amphibians 0 4.y. Fish 1925 1925 4.z. TOTAL 3138 2048 8479 12927 10514 37106 EN 35 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 5884 11930 17814 5.b. Rats 67 1260 66 1393 5.c. Guinea-Pigs 180 741 921 5.d. Hamsters 0 5.e. Other Rodents 0 5.f. Rabbits 88 3490 3578 5.g. Cats 15 15 5.h. Dogs 18 18 5.i. Ferrets 0 5.j. Other Carnivores 0 5.k. Horses, donkeys and cross breds 292 14 306 5.l. Pigs 46 422 468 5.m. Goats 0 5.n. Sheep 3 97 100 5.o. Cattle 332 332 5.p. Prosimians 0 5.q. New World Monkeys 0 5.r. Old World Monkeys 0 5.s. Apes 0 5.t. Other Mammals 0 5.u. Quail 0 5.v. Other birds 48 458 100 606 5.w. Reptiles 0 5.x. Amphibians 0 5.y. Fish 90 90 5.z. TOTAL 6698 18777 0 66 0 100 25641 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 36 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 511 192 703 6.b. Rats 2755 41 474 3270 6.c. Guinea-Pigs 100 32 132 6.d. Hamsters 0 6.e. Other Rodents 0 6.f. Rabbits 171 12 19 202 6.g. Cats 0 6.h. Dogs 151 151 6.i. Ferrets 0 6.j. Other Carnivores 0 6.k. Horses, donkeys and cross breds 0 6.l. Pigs 100 100 6.m. Goats 0 6.n. Sheep 0 6.o. Cattle 0 6.p. Prosimians 0 6.q. New World Monkeys 0 6.r. Old World Monkeys 0 6.s. Apes 0 6.t. Other Mammals 0 6.u. Quail 0 6.v. Other birds 670 670 6.w. Reptiles 0 6.x. Amphibians 0 6.y. Fish 24468 9179 3835 37482 6.z. TOTAL 28156 9264 0 0 0 5290 42710 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 37 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 506 155 42 703 7.b. Rats 337 718 12 679 387 115 532 490 3270 7.c. Guinea-Pigs 10 116 6 132 7.d. Hamsters 0 7.e. Other Rodents 0 7.f. Rabbits 97 19 26 60 202 7.g. Cats 0 7.h. Dogs 15 80 56 151 7.i. Ferrets 0 7.j. Other Carnivores 0 7.k. Horses, donkeys and cross breds 0 7.l. Pigs 100 100 7.m. Goats 0 7.n. Sheep 0 7.o. Cattle 0 7.p. Prosimians 0 7.q. New World Monkeys 0 7.r. Old World Monkeys 0 7.s. Apes 0 7.t. Other Mammals 0 7.u. Quail 0 7.v. Other birds 670 670 7.w. Reptiles 0 7.x. Amphibians 0 7.y. Fish 33782 3700 37482 7.z. TOTAL 34134 506 718 107 302 32 759 0 387 115 532 3700 1418 42710 EN 38 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates 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 255 506 68 35 11 477 138 1028 2518 8.b. Products/substances used or intended to be used mainly in agriculture 750 400 12 12 210 1384 8.c. Products/substances used or intended to be used mainly in industry 1067 318 39 255 21 270 387 95 532 975 126 4085 8.d. Products/substances used or intended to be used mainly in the household 549 549 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 422 422 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 625 625 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 0 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 30421 20 45 1637 54 32177 8.i. Other toxicological or safety evaluations 950 950 8.j. TOTAL 33464 506 718 107 302 32 759 625 387 115 577 3700 1418 42710 EN 39 EN DENMARK Statistical data submitted The statistical data have been submitted by the “Dyreforsøgstilsynet” (Animal Experiments Inspectorate). Comments of Danish authorities None EN 40 EN 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) 168164 119674 44406 337 3747 1.b. Rats (Rattus norvegicus) 75850 42343 30618 687 2202 1.c. Guinea-Pigs (Cavia porcellus) 5343 703 4640 0 0 1.d. Hamsters (Mesocricetus ) 4 4 0 0 0 1.e. Other Rodents (other Rodentia) 1760 1.f. Rabbits (Oryctolagus cuniculus) 2931 758 1044 0 1129 140 1.g. Cats (Felis catus) 154 0 17 4 133 0 1.h. Dogs (Canis familiaris) 271 0 250 0 21 39 1.i. Ferrets (Mustela putorius furo) 117 97 20 0 0 0 1.j. Other Carnivores (other Carnivora) 101 1.k. Horses, donkeys and cross breds (Equidae) 54 1.l. Pigs (Sus) 6863 1.m. Goats (Capra) 107 1.n. Sheep (Ovis) 88 1.o. Cattle (Bos) 939 1.p. Prosimians (Prosimia) 0 0 0 0 0 0 1.q. New World Monkeys (Ceboidea) 0 0 0 0 0 0 1.r. Old World Monkeys (Cercopithecoidea) 0 0 0 0 0 0 1.s. Apes (Hominoidea) 0 0 0 0 0 0 1.t. Other Mammals (other Mammalia) 243 1.u. Quail (Coturnix coturnix) 0 0 0 0 0 1.v. Other birds (other Aves) 2820 1.w. Reptiles (Reptilia) 221 1.x. Amphibians (Amphibia) 293 1.y. Fish (Pisces) 31245 1.z. TOTAL 297568 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 EN 41 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 53293 82439 11900 155 4923 2932 1096 11426 168164 2.b. Rats 15346 45628 3244 0 7269 833 2628 902 75850 2.c. Guinea-Pigs 207 2017 1695 25 1311 76 12 0 5343 2.d. Hamsters 4 0 0 0 0 0 0 0 4 2.e. Other Rodents 62 1698 0 0 0 0 0 0 1760 2.f. Rabbits 357 1808 447 4 218 2 42 53 2931 2.g. Cats 123 0 0 0 0 10 0 21 154 2.h. Dogs 1 119 0 0 130 21 0 0 271 2.i. Ferrets 97 20 0 0 0 0 0 0 117 2.j. Other Carnivores 62 39 0 0 0 0 0 0 101 2.k. Horses, donkeys and cross breds 15 13 7 0 0 0 19 0 54 2.l. Pigs 2245 1862 0 43 648 102 1029 934 6863 2.m. Goats 0 93 0 0 0 0 0 14 107 2.n. Sheep 5 38 26 6 0 0 13 0 88 2.o. Cattle 616 124 0 18 0 131 50 0 939 2.p. Prosimians 0 0 0 0 0 0 0 0 0 2.q. New World Monkeys 0 0 0 0 0 0 0 0 0 2.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 2.s. Apes 0 0 0 0 0 0 0 0 0 2.t. Other Mammals 233 0 0 0 0 0 10 0 243 2.u. Quail 0 0 0 0 0 0 0 0 0 2.v. Other birds 2604 111 2 84 6 13 0 0 2820 2.w. Reptiles 198 23 0 0 0 0 0 0 221 2.x. Amphibians 92 65 0 0 0 136 0 0 293 2.y. Fish 5939 16602 0 0 8443 0 261 0 31245 2.z. TOTAL 81499 152699 17321 335 22948 4256 5160 13350 297568 EN 42 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 2845 0 537 0 0 62 0 439 1040 4923 3.b. Rats 4515 74 0 1346 0 120 0 127 1087 7269 3.c. Guinea-Pigs 1260 0 0 0 0 24 0 0 27 1311 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 215 0 0 0 0 3 0 0 0 218 3.g. Cats 0 0 0 0 0 0 0 0 0 0 3.h. Dogs 130 0 0 0 0 0 0 0 0 130 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 648 0 0 0 0 0 0 0 0 648 3.m. Goats 0 0 0 0 0 0 0 0 0 0 3.n. Sheep 0 0 0 0 0 0 0 0 0 0 3.o. Cattle 0 0 0 0 0 0 0 0 0 0 3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 3.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 3.s. Apes 0 0 0 0 0 0 0 0 0 0 3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 3.u. Quail 0 0 0 0 0 0 0 0 0 0 3.v. Other birds 0 0 0 0 0 0 0 0 6 6 3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 3.y. Fish 0 0 493 0 0 0 7950 0 0 8443 3.z. TOTAL 9613 74 1030 1346 0 209 7950 566 2160 22948 EN 43 EN 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 2802 59758 13426 35581 1150 112717 4.b. Rats 2075 34100 823 19699 40 56737 4.c. Guinea-Pigs 269 1700 0 194 0 2163 4.d. Hamsters 0 0 0 0 0 0 4.e. Other Rodents 0 1416 0 282 24 1722 4.f. Rabbits 199 0 1129 757 21 2106 4.g. Cats 0 0 0 0 85 85 4.h. Dogs 21 39 0 80 0 140 4.i. Ferrets 0 20 0 97 0 117 4.j. Other Carnivores 0 0 0 0 0 0 4.k. Horses, donkeys and cross breds 0 0 0 0 15 15 4.l. Pigs 471 179 0 1869 111 2630 4.m. Goats 0 0 87 6 0 93 4.n. Sheep 0 0 0 0 0 0 4.o. Cattle 0 0 0 79 36 115 4.p. Prosimians 0 0 0 0 0 0 4.q. New World Monkeys 0 0 0 0 0 0 4.r. Old World Monkeys 0 0 0 0 0 0 4.s. Apes 0 0 0 0 0 0 4.t. Other Mammals 0 0 0 0 130 130 4.u. Quail 0 0 0 0 0 0 4.v. Other birds 64 0 0 0 240 304 4.w. Reptiles 0 0 0 0 0 0 4.x. Amphibians 0 151 0 0 0 151 4.y. Fish 0 8165 0 0 1180 9345 4.z. TOTAL 5901 105528 15465 58644 3032 188570 EN 44 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 155 14 0 0 11870 16 12055 5.b. Rats 0 2408 0 0 836 0 3244 5.c. Guinea-Pigs 25 0 0 0 1310 385 1720 5.d. Hamsters 0 0 0 0 0 0 0 5.e. Other Rodents 0 0 0 0 0 0 0 5.f. Rabbits 4 0 0 28 22 397 451 5.g. Cats 0 0 0 0 0 0 0 5.h. Dogs 0 0 0 0 0 0 0 5.i. Ferrets 0 0 0 0 0 0 0 5.j. Other Carnivores 0 0 0 0 0 0 0 5.k. Horses, donkeys and cross breds 0 0 0 0 0 7 7 5.l. Pigs 43 0 0 0 0 0 43 5.m. Goats 0 0 0 0 0 0 0 5.n. Sheep 6 0 0 0 0 26 32 5.o. Cattle 18 0 0 0 0 0 18 5.p. Prosimians 0 0 0 0 0 0 0 5.q. New World Monkeys 0 0 0 0 0 0 0 5.r. Old World Monkeys 0 0 0 0 0 0 0 5.s. Apes 0 0 0 0 0 0 0 5.t. Other Mammals 0 0 0 0 0 0 0 5.u. Quail 0 0 0 0 0 0 0 5.v. Other birds 84 0 0 0 0 2 86 5.w. Reptiles 0 0 0 0 0 0 0 5.x. Amphibians 0 0 0 0 0 0 0 5.y. Fish 0 0 0 0 0 0 0 5.z. TOTAL 335 2422 0 28 14038 833 17656 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 45 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 667 0 0 0 2366 1890 4923 6.b. Rats 98 0 0 50 4502 2619 7269 6.c. Guinea-Pigs 0 0 0 72 1188 51 1311 6.d. Hamsters 0 0 0 0 0 0 0 6.e. Other Rodents 0 0 0 0 0 0 0 6.f. Rabbits 0 0 0 0 216 2 218 6.g. Cats 0 0 0 0 0 0 0 6.h. Dogs 0 0 0 0 130 0 130 6.i. Ferrets 0 0 0 0 0 0 0 6.j. Other Carnivores 0 0 0 0 0 0 0 6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 6.l. Pigs 0 0 0 0 648 0 648 6.m. Goats 0 0 0 0 0 0 0 6.n. Sheep 0 0 0 0 0 0 0 6.o. Cattle 0 0 0 0 0 0 0 6.p. Prosimians 0 0 0 0 0 0 0 6.q. New World Monkeys 0 0 0 0 0 0 0 6.r. Old World Monkeys 0 0 0 0 0 0 0 6.s. Apes 0 0 0 0 0 0 0 6.t. Other Mammals 0 0 0 0 0 0 0 6.u. Quail 0 0 0 0 0 0 0 6.v. Other birds 6 0 0 0 0 0 6 6.w. Reptiles 0 0 0 0 0 0 0 6.x. Amphibians 0 0 0 0 0 0 0 6.y. Fish 493 0 0 0 0 7950 8443 6.z. TOTAL 1264 0 0 122 9050 12512 22948 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 46 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 0 0 1955 0 931 0 382 0 0 658 45 0 952 4923 7.b. Rats 0 0 1146 0 0 0 3146 0 0 174 2372 0 431 7269 7.c. Guinea-Pigs 0 0 1223 0 0 0 0 0 0 0 0 0 88 1311 7.d. Hamsters 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.f. Rabbits 0 0 46 19 0 3 39 0 0 0 109 0 2 218 7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.h. Dogs 0 0 0 0 0 0 126 0 0 0 0 0 4 130 7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.l. Pigs 0 0 8 12 0 0 600 0 0 0 28 0 0 648 7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.v. Other birds 0 0 6 0 0 0 0 0 0 0 0 0 0 6 7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.y. Fish 199 7950 0 0 0 0 0 0 0 0 0 294 0 8443 7.z. TOTAL 199 7950 4384 31 931 3 4293 0 0 832 2554 294 1477 22948 EN 47 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates 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 125 0 4027 31 407 0 4366 0 0 148 401 0 108 9613 8.b. Products/substances used or intended to be used mainly in agriculture 0 0 0 0 0 0 18 0 0 0 56 0 0 74 8.c. Products/substances used or intended to be used mainly in industry 199 0 0 0 188 0 294 0 0 0 45 0 304 1030 8.d. Products/substances used or intended to be used mainly in the household 0 0 0 0 0 0 0 0 0 0 1016 0 330 1346 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 0 0 0 0 0 3 120 0 0 0 0 0 86 209 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 0 7950 0 0 0 0 0 0 0 0 0 0 0 7950 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 0 0 0 0 0 0 0 0 0 566 0 0 0 566 8.i. Other toxicological or safety evaluations 0 0 21 0 336 0 0 0 0 118 1041 0 644 2160 8.j. TOTAL 324 7950 4048 31 931 3 4798 0 0 832 2559 0 1472 22948 EN 48 EN GERMANY Statistical data submitted The statistical data have been submitted by the "Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft" (Federal Ministry for Consumer protection, Food and Agriculture). Comments of German authorities The German Government's aim is to reduce to an unavoidable minimum the number of animals used for experimental and other scientific purposes. In the current state of the art, however, despite the increased use of alternative methods it is not yet possible to dispense with animal experiments entirely. This applies to medical research in particular. Within the EU, Germany is making a major contribution towards the development of test methods which do not involve animal experiments. A leading part in this process is played both by the Federal Ministry of Education and Research, with its scheme to promote the development of methods to replace animal experiments and by the Central Office for the registration and assessment of methods replacing and supplementing animal experiments, which this year is celebrating its 20th anniversary. Compared with the previous year, in 2008 in Germany the number of vertebrates used for experimental and other scientific purposes increased by 2,1% to 2,021,782. Whereas the number of mice used increased by 135,459 the number of fish used fell by 95,565. At almost 87%, rodents constitute the largest group of animals used in experiments. In particular, mice account for 65% and rats for 19%. The next largest groups comprise rabbits at 4,8%, fish at 3,3% and birds at 2,8%. All other species taken together account for 2,2% of the animals used. Compared with the previous year, the number of Old World monkeys, New World monkeys and prosimians fell by 152 to 2,263. The largest proportion of these animals (1,858) was used for toxicological tests and other safety tests on products and appliances for human, dental and veterinary medicine. Apes were not used. Compared with 2007, the number of dogs and cats used fell by 340; the total number corresponded roughly to the numbers for 2000 to 2006. For basic biological research the number of fish used fell by 88,760 and the number of rats by 18,122. By contrast, the number of mice rose by 41,775 and the number of amphibians by 5,676. In total, 68,519 fewer animals were used in basic biological research (-7,3%). For the research and development of products and for the manufacture and/or quality control of products for human, dental and veterinary medicine, 858,395 animals were used – an increase of 122,052 compared with the previous year. By contrast, in 2007, 97,770 fewer animals were used than in 2006. In the years 2001 to 2005 the number of animals used for these purposes was likewise within this range. For toxicological tests and other safety tests on products and appliances for human, dental and veterinary medicine, 8,432 more animals were required than in 2007. EN 49 EN For products or substances used primarily in cosmetics or toiletries, no toxicological tests were carried out on animals in 2008 in Germany. The proportion of animals used for research into human or animal diseases fell in 2008 compared with the previous year from 58,5% to 56,1%. 24,6% of the animals were used for legally required experiments in the manufacture or quality control of products for human, dental or veterinary medicine and/or for toxicological safety tests. Their proportion therefore increased by 5,0%. EN 50 EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin versus species 1.1 Species 1.2 Total 1.3 Animals coming from registered breeding or supplying establishments within the reporting country 1.4 Animals coming from elsewhere in the EC 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) 1.6 Animals coming from other origins 1.7 Re-used animals 1.a. Mice (Mus musculus) 1.314.493 1.167.335 129.636 10.760 6.762 1.b. Rats (Rattus norvegicus) 390.853 305.309 79.003 5.395 1.146 1.c. Guinea-Pigs (Cavia porcellus) 35.870 35.624 246 0 0 1.d. Hamsters (Mesocricetus ) 7.061 6.782 149 0 130 1.e. Other Rodents (other Rodentia) 8.392 1.f. Rabbits (Oryctolagus cuniculus) 97.938 97.313 621 4 0 9.076 1.g. Cats (Felis catus) 798 246 294 0 258 303 1.h. Dogs (Canis familiaris) 4.450 1.911 1.536 0 1.003 1.081 1.i. Ferrets (Mustela putorius furo) 55 11 44 0 0 0 1.j. Other Carnivores (other Carnivora) 410 1.k. Horses, donkeys and cross breds (Equidae) 584 1.l. Pigs (Sus) 12.361 1.m. Goats (Capra) 531 1.n. Sheep (Ovis) 4.638 1.o. Cattle (Bos) 6.252 1.p. Prosimians (Prosimia) 543 0 543 0 0 0 1.q. New World Monkeys (Ceboidea) 305 252 48 5 0 63 1.r. Old World Monkeys (Cercopithecoidea) 1.415 102 205 0 1.108 396 1.s. Apes (Hominoidea) 0 0 0 0 0 0 1.t. Other Mammals (other Mammalia) 541 1.u. Quail (Coturnix coturnix) 1.803 1.803 0 0 0 1.v. Other birds (other Aves) 53.986 1.w. Reptiles (Reptilia) 192 1.x. Amphibians (Amphibia) 10.815 1.y. Fish (Pisces) 67.496 1.z. TOTAL 2.021.782 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 EN 51 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 723.037 273.935 148.754 41.668 75.985 7.855 26.200 17.059 1.314.493 2.b. Rats 74.880 180.418 51.412 10.468 53.312 1.609 16.248 2.506 390.853 2.c. Guinea-Pigs 936 6.002 16.870 3.700 6.623 18 616 1.105 35.870 2.d. Hamsters 2.036 2.822 16 1.331 40 52 295 469 7.061 2.e. Other Rodents 3.497 3.934 0 0 0 17 391 553 8.392 2.f. Rabbits 2.453 5.387 50.713 1.809 4.483 791 196 32.106 97.938 2.g. Cats 79 547 39 10 98 0 13 12 798 2.h. Dogs 193 1.003 0 939 1.935 189 161 30 4.450 2.i. Ferrets 42 0 0 2 0 0 1 10 55 2.j. Other Carnivores 15 0 0 311 0 80 0 4 410 2.k. Horses, donkeys and cross breds 346 121 0 2 0 75 39 1 584 2.l. Pigs 2.633 5.918 29 447 352 693 2.079 210 12.361 2.m. Goats 225 271 11 2 4 10 2 6 531 2.n. Sheep 692 1.150 2.151 116 3 167 216 143 4.638 2.o. Cattle 4.295 528 22 436 33 622 282 34 6.252 2.p. Prosimians 0 0 0 0 543 0 0 0 543 2.q. New World Monkeys 49 91 0 0 147 0 0 18 305 2.r. Old World Monkeys 43 91 0 0 1.168 2 10 101 1.415 2.s. Apes 0 0 0 0 0 0 0 0 0 2.t. Other Mammals 495 6 4 0 0 0 7 29 541 2.u. Quail 0 0 0 0 1.786 0 17 0 1.803 2.v. Other birds 7.095 29.863 307 11.714 885 2.245 462 1.415 53.986 2.w. Reptiles 151 21 0 0 0 0 20 0 192 2.x. Amphibians 9.477 234 0 0 4 0 1.064 36 10.815 2.y. Fish 34.405 2.730 0 40 23.853 2.421 3.571 476 67.496 2.z. TOTAL 867.074 515.072 270.328 72.995 171.254 16.846 51.890 56.323 2.021.782 EN 52 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 61.040 4.146 10.375 0 0 0 0 217 207 75.985 3.b. Rats 33.080 8.284 11.425 16 0 0 0 239 268 53.312 3.c. Guinea-Pigs 3.613 1.449 1.482 0 0 0 0 0 79 6.623 3.d. Hamsters 40 0 0 0 0 0 0 0 0 40 3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 3.f. Rabbits 2.861 952 633 0 0 0 0 0 37 4.483 3.g. Cats 88 0 0 0 0 0 0 0 10 98 3.h. Dogs 1.902 20 8 0 0 0 0 0 5 1.935 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 352 0 0 0 0 0 0 0 0 352 3.m. Goats 0 4 0 0 0 0 0 0 0 4 3.n. Sheep 3 0 0 0 0 0 0 0 0 3 3.o. Cattle 33 0 0 0 0 0 0 0 0 33 3.p. Prosimians 543 0 0 0 0 0 0 0 0 543 3.q. New World Monkeys 147 0 0 0 0 0 0 0 0 147 3.r. Old World Monkeys 1.168 0 0 0 0 0 0 0 0 1.168 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 1.786 0 0 0 0 0 0 0 1.786 3.v. Other birds 182 577 0 0 0 0 44 0 82 885 3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 3.x. Amphibians 0 0 0 0 0 0 0 0 4 4 3.y. Fish 3.855 14.681 2.367 0 0 0 80 2.870 0 23.853 3.z. TOTAL 108.907 31.899 26.290 16 0 0 124 3.326 692 171.254 EN 53 EN 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 60.950 105.707 107.646 388.614 5.404 668.321 4.b. Rats 16.279 26.241 4.369 87.061 1.014 134.964 4.c. Guinea-Pigs 130 47 0 4.271 239 4.687 4.d. Hamsters 387 825 98 2.531 45 3.886 4.e. Other Rodents 0 814 0 2.623 1.439 4.876 4.f. Rabbits 758 106 304 2.413 194 3.775 4.g. Cats 0 40 0 0 527 567 4.h. Dogs 3 0 75 84 765 927 4.i. Ferrets 0 0 0 35 0 35 4.j. Other Carnivores 0 0 0 2 80 82 4.k. Horses, donkeys and cross breds 0 0 0 43 294 337 4.l. Pigs 447 7 10 2.170 2.359 4.993 4.m. Goats 0 29 0 203 10 242 4.n. Sheep 59 48 0 528 919 1.554 4.o. Cattle 9 21 0 79 4.603 4.712 4.p. Prosimians 0 0 0 0 0 0 4.q. New World Monkeys 0 21 0 26 0 47 4.r. Old World Monkeys 4 16 0 80 0 100 4.s. Apes 0 0 0 0 0 0 4.t. Other Mammals 0 44 0 42 0 86 4.u. Quail 0 0 0 0 0 0 4.v. Other birds 118 48 0 2.239 7.706 10.111 4.w. Reptiles 0 10 0 0 47 57 4.x. Amphibians 224 56 0 468 0 748 4.y. Fish 1.768 958 131 3.913 5.368 12.138 4.z. TOTAL 81.136 135.038 112.633 497.425 31.013 857.245 EN 54 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 0 174.107 0 850 11.320 4.145 190.422 5.b. Rats 0 61.747 0 0 0 133 61.880 5.c. Guinea-Pigs 0 19.743 0 512 0 315 20.570 5.d. Hamsters 0 1.347 0 0 0 0 1.347 5.e. Other Rodents 0 0 0 0 0 0 0 5.f. Rabbits 0 42.765 0 0 8.697 1.060 52.522 5.g. Cats 0 39 0 0 0 10 49 5.h. Dogs 0 217 0 0 680 42 939 5.i. Ferrets 0 2 0 0 0 0 2 5.j. Other Carnivores 0 311 0 0 0 0 311 5.k. Horses, donkeys and cross breds 0 2 0 0 0 0 2 5.l. Pigs 0 436 0 0 0 40 476 5.m. Goats 0 0 0 0 2 11 13 5.n. Sheep 0 0 0 0 58 2.209 2.267 5.o. Cattle 0 412 0 0 0 46 458 5.p. Prosimians 0 0 0 0 0 0 0 5.q. New World Monkeys 0 0 0 0 0 0 0 5.r. Old World Monkeys 0 0 0 0 0 0 0 5.s. Apes 0 0 0 0 0 0 0 5.t. Other Mammals 0 0 0 0 0 4 4 5.u. Quail 0 0 0 0 0 0 0 5.v. Other birds 0 1.005 0 0 10.158 858 12.021 5.w. Reptiles 0 0 0 0 0 0 0 5.x. Amphibians 0 0 0 0 0 0 0 5.y. Fish 0 40 0 0 0 0 40 5.z. TOTAL 0 302.173 0 1.362 30.915 8.873 343.323 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 55 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 153 55.706 0 537 16.213 3.376 75.985 6.b. Rats 110 27.852 10 16 21.608 3.716 53.312 6.c. Guinea-Pigs 0 4.117 0 0 2.503 3 6.623 6.d. Hamsters 0 40 0 0 0 0 40 6.e. Other Rodents 0 0 0 0 0 0 0 6.f. Rabbits 0 3.515 0 0 891 77 4.483 6.g. Cats 14 74 0 0 0 10 98 6.h. Dogs 36 777 0 0 1.093 29 1.935 6.i. Ferrets 0 0 0 0 0 0 0 6.j. Other Carnivores 0 0 0 0 0 0 0 6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 6.l. Pigs 0 205 0 0 135 12 352 6.m. Goats 0 0 0 0 4 0 4 6.n. Sheep 0 0 0 0 0 3 3 6.o. Cattle 0 33 0 0 0 0 33 6.p. Prosimians 0 543 0 0 0 0 543 6.q. New World Monkeys 0 0 0 0 147 0 147 6.r. Old World Monkeys 0 0 0 0 1.168 0 1.168 6.s. Apes 0 0 0 0 0 0 0 6.t. Other Mammals 0 0 0 0 0 0 0 6.u. Quail 0 320 0 0 1.466 0 1.786 6.v. Other birds 0 320 0 0 483 82 885 6.w. Reptiles 0 0 0 0 0 0 0 6.x. Amphibians 0 0 0 0 0 4 4 6.y. Fish 1.270 8.128 0 0 12.847 1.608 23.853 6.z. TOTAL 1.583 101.630 10 553 58.558 8.920 171.254 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 56 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 28.611 8.594 12.390 70 9.944 0 1.804 1.068 0 6.227 0 0 7.277 75.985 7.b. Rats 2.510 5.884 18.972 25 0 0 5.704 0 3.393 3.974 5.647 0 7.203 53.312 7.c. Guinea-Pigs 0 0 843 0 5.653 0 0 0 0 0 15 0 112 6.623 7.d. Hamsters 0 0 0 0 0 0 0 0 0 0 0 0 40 40 7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.f. Rabbits 28 18 171 925 0 479 0 0 925 0 1.426 0 511 4.483 7.g. Cats 0 0 24 0 0 0 62 0 0 0 0 0 12 98 7.h. Dogs 0 339 747 0 0 0 639 0 0 0 0 0 210 1.935 7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.l. Pigs 0 11 88 0 0 0 34 0 0 0 0 0 219 352 7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 4 4 7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 3 3 7.o. Cattle 0 0 16 0 0 0 0 0 0 0 0 0 17 33 7.p. Prosimians 0 0 261 0 0 0 143 0 0 0 0 0 139 543 7.q. New World Monkeys 0 0 36 0 0 0 47 0 64 0 0 0 0 147 7.r. Old World Monkeys 0 0 184 0 0 0 750 0 176 0 58 0 0 1.168 7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.u. Quail 459 217 0 0 0 0 0 0 0 0 176 0 934 1.786 7.v. Other birds 204 0 205 0 0 0 0 0 0 0 0 0 476 885 7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.x. Amphibians 0 0 0 0 0 0 0 0 4 0 0 0 0 4 7.y. Fish 2.446 326 0 0 0 0 294 0 0 0 129 19.443 1.215 23.853 7.z. TOTAL 34.258 15.389 33.937 1.020 15.597 479 9.477 1.068 4.562 10.201 7.451 19.443 18.372 171.254 EN 57 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates not included in other columns 8.12 Other 8.13 Total 8.2.1. LD50, LC50 8.2.2 Other lethal methods 8.2.3 Non lethal clinical signs methods 8.a. Products/substances or devices for human medicine and dentistry and for veterinary medicine 28.654 12.043 26.171 497 5.551 3 7.274 1.008 1.551 4.218 4.786 3.412 13.739 108.907 8.b. Products/substances used or intended to be used mainly in agriculture 3.244 2.572 2.680 367 2.793 372 974 0 1.072 1.271 725 11.884 3.945 31.899 8.c. Products/substances used or intended to be used mainly in industry 2.046 566 4.671 156 7.177 91 1.209 60 1.935 4.322 1.928 1.895 234 26.290 8.d. Products/substances used or intended to be used mainly in the household 16 0 0 0 0 0 0 0 0 0 0 0 0 16 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 0 0 0 0 0 0 0 0 0 0 0 80 44 124 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 289 208 239 0 0 0 20 0 0 0 12 2.172 386 3.326 8.i. Other toxicological or safety evaluations 9 0 176 0 76 13 0 0 4 390 0 0 24 692 8.j. TOTAL 34.258 15.389 33.937 1.020 15.597 479 9.477 1.068 4.562 10.201 7.451 19.443 18.372 171.254 EN 58 EN ESTONIA Statistical data submitted The statistical data have been submitted by the Animal Welfare and Zootechnics bureau of the Ministry of Agriculture Comments of Estonian authorities Estonia has 7 approved experimental animal breeding and user establishments. Four of them are active by the University of Tartu. Commission of the authorization of the animal testing permits first started in August 2004. During the period 2005-2008 there have been issued over a 100 licenses for conducting animal experiments in Estonia. Most of the experiments have been conducted at the University of Tartu. The majority of laboratory animals used are from authorized breeding establishments in Estonia. The most of experiments have been carried out in the fields of biological studies of a fundamental nature and research and development of products and devices for human medicine. In the field of biological studies, the majority of experiments involved the investigation of human diseases (nervous and mental illnesses, various forms of cancer). The authorization and licensing animal testing and conducting animal experiments is regulated by national and EU legislation. EN 59 EN 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) 28754 11779 13137 3838 1.b. Rats (Rattus norvegicus) 5268 2058 3210 0 0 1.c. Guinea-Pigs (Cavia porcellus) 22 22 1.d. Hamsters (Mesocricetus ) 120 120 1.e. Other Rodents (other Rodentia) 0 1.f. Rabbits (Oryctolagus cuniculus) 630 0 630 0 0 0 1.g. Cats (Felis catus) 0 1.h. Dogs (Canis familiaris) 0 1.i. Ferrets (Mustela putorius furo) 0 1.j. Other Carnivores (other Carnivora) 0 1.k. Horses, donkeys and cross breds (Equidae) 0 1.l. Pigs (Sus) 1.m. Goats (Capra) 0 1.n. Sheep (Ovis) 1.o. Cattle (Bos) 0 1.p. Prosimians (Prosimia) 0 1.q. New World Monkeys (Ceboidea) 0 1.r. Old World Monkeys (Cercopithecoidea) 0 1.s. Apes (Hominoidea) 0 1.t. Other Mammals (other Mammalia) 1.u. Quail (Coturnix coturnix) 0 1.v. Other birds (other Aves) 1.w. Reptiles (Reptilia) 1.x. Amphibians (Amphibia) 1.y. Fish (Pisces) 1.z. TOTAL 34794 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 EN 60 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 24323 4291 100 40 28754 2.b. Rats 2870 2398 5268 2.c. Guinea-Pigs 22 22 2.d. Hamsters 15 105 120 2.e. Other Rodents 0 2.f. Rabbits 510 120 630 2.g. Cats 0 2.h. Dogs 0 2.i. Ferrets 0 2.j. Other Carnivores 0 2.k. Horses, donkeys and cross breds 0 2.l. Pigs 0 2.m. Goats 0 2.n. Sheep 0 2.o. Cattle 0 2.p. Prosimians 0 2.q. New World Monkeys 0 2.r. Old World Monkeys 0 2.s. Apes 0 2.t. Other Mammals 0 2.u. Quail 0 2.v. Other birds 0 2.w. Reptiles 0 2.x. Amphibians 0 2.y. Fish 0 2.z. TOTAL 27718 6914 100 0 40 22 0 0 34794 EN 61 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 40 40 3.b. Rats 0 3.c. Guinea-Pigs 0 3.d. Hamsters 0 3.e. Other Rodents 0 3.f. Rabbits 0 3.g. Cats 0 3.h. Dogs 0 3.i. Ferrets 0 3.j. Other Carnivores 0 3.k. Horses, donkeys and cross breds 0 3.l. Pigs 0 3.m. Goats 0 3.n. Sheep 0 3.o. Cattle 0 3.p. Prosimians 0 3.q. New World Monkeys 0 3.r. Old World Monkeys 0 3.s. Apes 0 3.t. Other Mammals 0 3.u. Quail 0 3.v. Other birds 0 3.w. Reptiles 0 3.x. Amphibians 0 3.y. Fish 0 3.z. TOTAL 0 0 0 0 0 40 0 0 0 40 EN 62 EN 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 621 11357 10124 6512 28614 4.b. Rats 510 3412 1346 5268 4.c. Guinea-Pigs 22 22 4.d. Hamsters 120 120 4.e. Other Rodents 0 4.f. Rabbits 630 630 4.g. Cats 0 4.h. Dogs 0 4.i. Ferrets 0 4.j. Other Carnivores 0 4.k. Horses, donkeys and cross breds 0 4.l. Pigs 0 4.m. Goats 0 4.n. Sheep 0 4.o. Cattle 0 4.p. Prosimians 0 4.q. New World Monkeys 0 4.r. Old World Monkeys 0 4.s. Apes 0 4.t. Other Mammals 0 4.u. Quail 0 4.v. Other birds 0 4.w. Reptiles 0 4.x. Amphibians 0 4.y. Fish 0 4.z. TOTAL 1131 14769 10124 8608 22 34654 EN 63 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 100 100 5.b. Rats 0 5.c. Guinea-Pigs 0 5.d. Hamsters 0 5.e. Other Rodents 0 5.f. Rabbits 0 5.g. Cats 0 5.h. Dogs 0 5.i. Ferrets 0 5.j. Other Carnivores 0 5.k. Horses, donkeys and cross breds 0 5.l. Pigs 0 5.m. Goats 0 5.n. Sheep 0 5.o. Cattle 0 5.p. Prosimians 0 5.q. New World Monkeys 0 5.r. Old World Monkeys 0 5.s. Apes 0 5.t. Other Mammals 0 5.u. Quail 0 5.v. Other birds 0 5.w. Reptiles 0 5.x. Amphibians 0 5.y. Fish 0 5.z. TOTAL 0 0 0 0 100 0 100 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 64 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 40 40 6.b. Rats 0 6.c. Guinea-Pigs 0 6.d. Hamsters 0 6.e. Other Rodents 0 6.f. Rabbits 0 6.g. Cats 0 6.h. Dogs 0 6.i. Ferrets 0 6.j. Other Carnivores 0 6.k. Horses, donkeys and cross breds 0 6.l. Pigs 0 6.m. Goats 0 6.n. Sheep 0 6.o. Cattle 0 6.p. Prosimians 0 6.q. New World Monkeys 0 6.r. Old World Monkeys 0 6.s. Apes 0 6.t. Other Mammals 0 6.u. Quail 0 6.v. Other birds 0 6.w. Reptiles 0 6.x. Amphibians 0 6.y. Fish 0 6.z. TOTAL 0 0 0 0 40 0 40 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 65 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 40 40 7.b. Rats 0 7.c. Guinea-Pigs 0 7.d. Hamsters 0 7.e. Other Rodents 0 7.f. Rabbits 0 7.g. Cats 0 7.h. Dogs 0 7.i. Ferrets 0 7.j. Other Carnivores 0 7.k. Horses, donkeys and cross breds 0 7.l. Pigs 0 7.m. Goats 0 7.n. Sheep 0 7.o. Cattle 0 7.p. Prosimians 0 7.q. New World Monkeys 0 7.r. Old World Monkeys 0 7.s. Apes 0 7.t. Other Mammals 0 7.u. Quail 0 7.v. Other birds 0 7.w. Reptiles 0 7.x. Amphibians 0 7.y. Fish 0 7.z. TOTAL 0 0 40 0 0 0 0 0 0 0 0 0 0 40 EN 66 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates not included in other columns 8.12 Other 8.13 Total 8.2.1. LD50, LC50 8.2.2 Other lethal methods 8.2.3 Non lethal clinical signs methods 8.a. Products/substances or devices for human medicine and dentistry and for veterinary medicine 0 8.b. Products/substances used or intended to be used mainly in agriculture 0 8.c. Products/substances used or intended to be used mainly in industry 0 8.d. Products/substances used or intended to be used mainly in the household 0 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 0 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 40 40 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 0 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 0 8.i. Other toxicological or safety evaluations 0 8.j. TOTAL 0 40 0 0 0 0 0 0 0 0 0 0 0 40 EN 67 EN IRELAND Statistical data submitted The statistical data for Ireland have been provided by the Department of Health and Children. Comments of Irish authorities A total of 112,835 animals were used. This represents an increase of 197% compared to 2005. 259 new licences were issued in 2008. This is an increase of 51% compared to 2005. Rodents accounted for 74% of all animals used which compares to 67% in 2005. Fish accounted for 20% of all animals. No non-human primates were used. This was in accordance with Ireland’s policy not to licence for the use of non-human primates. Of the animals used, 24% (26,609) were bred in registered breeding establishments in Ireland while 55% (62,003) came from other Member States in the EC. Universities and Colleges accounted for 24% (27,198) of all animals used in scientific procedures. Regulatory requirements (52,325) and studies related to human and animal diseases (40,233) accounted for 82% of all animals used in scientific procedures. Animals Used for Selected Purposes 10% of animals (10,908) were involved in studies specific to animal diseases. Of the 224 pigs used in 2005, 88% (196) were involved in studies on human and animal diseases. 295 cats were used, 98 of which were used in toxicology and other safety evaluations. 557 dogs were used, 105 of which were used in toxicology and other safety evaluations. 59% (120) of rabbits used were for the study of human or animal diseases. 144 horses were used, a decrease of 45 since 2005. 69% of the horses used were for EC legislation including European Pharmacopoeia requirements. Toxicological and other Safety Evaluations No animals were used in the testing of cosmetic products. This was in accordance with Ireland’s policy not to licence procedures involving the testing of cosmetics. Toxicological and other safety evaluations accounted for 46% (52,065) of animals used which compares with 18% in 2005. 99% of the animals used in toxicological and other safety evaluations were mice. EN 68 EN 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) 71.224 12.271 57.264 1.009 680 1.b. Rats (Rattus norvegicus) 11.741 4.396 4.423 2.880 42 1.c. Guinea-Pigs (Cavia porcellus) 91 59 32 0 0 1.d. Hamsters (Mesocricetus ) 68 4 64 0 0 1.e. Other Rodents (other Rodentia) 1.f. Rabbits (Oryctolagus cuniculus) 204 6 198 0 0 0 1.g. Cats (Felis catus) 295 295 0 0 0 16 1.h. Dogs (Canis familiaris) 557 547 10 0 0 198 1.i. Ferrets (Mustela putorius furo) 1.j. Other Carnivores (other Carnivora) 1.k. Horses, donkeys and cross breds (Equidae) 144 1.l. Pigs (Sus) 224 1.m. Goats (Capra) 1.n. Sheep (Ovis) 456 1.o. Cattle (Bos) 4.019 1.p. Prosimians (Prosimia) 1.q. New World Monkeys (Ceboidea) 1.r. Old World Monkeys (Cercopithecoidea) 1.s. Apes (Hominoidea) 1.t. Other Mammals (other Mammalia) 32 1.u. Quail (Coturnix coturnix) 1.v. Other birds (other Aves) 582 1.w. Reptiles (Reptilia) 1.x. Amphibians (Amphibia) 1.y. Fish (Pisces) 23.198 1.z. TOTAL 112.835 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 EN 69 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 15.813 2.487 0 0 51.456 426 14 1.028 71.224 2.b. Rats 6.750 4.506 0 0 243 57 12 173 11.741 2.c. Guinea-Pigs 32 0 0 0 59 0 0 0 91 2.d. Hamsters 4 64 0 0 0 0 0 0 68 2.e. Other Rodents 0 2.f. Rabbits 6 114 0 0 84 0 0 0 204 2.g. Cats 0 197 0 0 98 0 0 0 295 2.h. Dogs 0 442 0 0 105 0 0 10 557 2.i. Ferrets 0 2.j. Other Carnivores 0 2.k. Horses, donkeys and cross breds 21 0 0 99 0 3 13 8 144 2.l. Pigs 175 21 0 12 16 0 0 0 224 2.m. Goats 0 2.n. Sheep 282 2 0 10 0 120 42 0 456 2.o. Cattle 3.563 29 0 139 0 90 12 186 4.019 2.p. Prosimians 0 2.q. New World Monkeys 0 2.r. Old World Monkeys 0 2.s. Apes 0 2.t. Other Mammals 0 32 0 0 0 0 0 0 32 2.u. Quail 0 2.v. Other birds 201 287 0 0 4 90 0 0 582 2.w. Reptiles 0 2.x. Amphibians 0 2.y. Fish 3.019 1.400 0 0 0 0 0 18.779 23.198 2.z. TOTAL 29.866 9.581 0 260 52.065 786 93 20.184 112.835 EN 70 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 12 0 0 0 0 51.444 51.456 3.b. Rats 243 243 3.c. Guinea-Pigs 0 0 0 0 0 59 59 3.d. Hamsters 0 3.e. Other Rodents 0 3.f. Rabbits 84 84 3.g. Cats 98 0 0 0 0 0 98 3.h. Dogs 105 0 0 0 0 0 105 3.i. Ferrets 0 3.j. Other Carnivores 0 3.k. Horses, donkeys and cross breds 0 3.l. Pigs 16 0 0 0 0 0 16 3.m. Goats 0 3.n. Sheep 0 3.o. Cattle 0 3.p. Prosimians 0 3.q. New World Monkeys 0 3.r. Old World Monkeys 0 3.s. Apes 0 3.t. Other Mammals 0 3.u. Quail 4 0 0 0 0 0 4 3.v. Other birds 0 3.w. Reptiles 0 3.x. Amphibians 0 3.y. Fish 0 3.z. TOTAL 235 0 0 0 0 0 0 0 51.830 52.065 EN 71 EN 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 770 5.534 2.374 9.030 1.018 18.726 4.b. Rats 1.525 7.778 42 1.840 128 11.313 4.c. Guinea-Pigs 0 0 0 32 0 32 4.d. Hamsters 0 0 0 64 4 68 4.e. Other Rodents 0 4.f. Rabbits 49 0 0 69 2 120 4.g. Cats 0 0 0 0 197 197 4.h. Dogs 0 0 0 4 438 442 4.i. Ferrets 0 4.j. Other Carnivores 0 4.k. Horses, donkeys and cross breds 24 24 4.l. Pigs 94 43 0 59 196 4.m. Goats 0 4.n. Sheep 2 0 0 0 402 404 4.o. Cattle 0 0 0 0 3.682 3.682 4.p. Prosimians 0 4.q. New World Monkeys 0 4.r. Old World Monkeys 0 4.s. Apes 0 4.t. Other Mammals 32 32 4.u. Quail 0 4.v. Other birds 12 2 1 563 578 4.w. Reptiles 0 4.x. Amphibians 0 4.y. Fish 60 0 0 0 4.359 4.419 4.z. TOTAL 2.512 13.312 2.461 11.040 10.908 40.233 EN 72 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 0 5.b. Rats 0 5.c. Guinea-Pigs 0 5.d. Hamsters 0 5.e. Other Rodents 0 5.f. Rabbits 0 5.g. Cats 0 5.h. Dogs 0 5.i. Ferrets 0 5.j. Other Carnivores 0 5.k. Horses, donkeys and cross breds 0 99 0 0 0 0 99 5.l. Pigs 12 0 0 0 0 0 12 5.m. Goats 0 5.n. Sheep 0 10 0 0 0 0 10 5.o. Cattle 0 91 0 0 0 48 139 5.p. Prosimians 0 5.q. New World Monkeys 0 5.r. Old World Monkeys 0 5.s. Apes 0 5.t. Other Mammals 0 5.u. Quail 0 5.v. Other birds 0 5.w. Reptiles 0 5.x. Amphibians 0 5.y. Fish 0 5.z. TOTAL 12 200 0 0 0 48 260 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 73 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 0 5.106 0 0 46.328 22 51.456 6.b. Rats 15 0 0 0 228 0 243 6.c. Guinea-Pigs 0 0 0 0 59 0 59 6.d. Hamsters 0 6.e. Other Rodents 0 6.f. Rabbits 0 0 0 0 84 0 84 6.g. Cats 83 15 0 0 0 0 98 6.h. Dogs 57 48 0 0 0 0 105 6.i. Ferrets 0 6.j. Other Carnivores 0 6.k. Horses, donkeys and cross breds 0 6.l. Pigs 16 0 0 0 0 0 16 6.m. Goats 0 6.n. Sheep 0 6.o. Cattle 0 6.p. Prosimians 0 6.q. New World Monkeys 0 6.r. Old World Monkeys 0 6.s. Apes 0 6.t. Other Mammals 0 6.u. Quail 0 6.v. Other birds 4 0 0 0 0 0 4 6.w. Reptiles 0 6.x. Amphibians 0 6.y. Fish 0 6.z. TOTAL 175 5.169 0 0 46.699 22 52.065 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 74 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 42.721 1.866 0 0 0 0 0 0 0 0 0 0 6.869 51.456 7.b. Rats 0 0 0 0 0 0 0 0 15 0 0 0 228 243 7.c. Guinea-Pigs 0 0 0 0 0 0 0 0 0 0 0 0 59 59 7.d. Hamsters 0 7.e. Other Rodents 0 7.f. Rabbits 0 0 0 0 0 0 0 0 0 0 0 84 84 7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 98 98 7.h. Dogs 0 0 0 0 0 0 0 0 0 0 0 105 105 7.i. Ferrets 0 7.j. Other Carnivores 0 7.k. Horses, donkeys and cross breds 0 7.l. Pigs 0 0 0 0 0 0 0 0 0 0 0 0 16 16 7.m. Goats 0 7.n. Sheep 0 7.o. Cattle 0 7.p. Prosimians 0 7.q. New World Monkeys 0 7.r. Old World Monkeys 0 7.s. Apes 0 7.t. Other Mammals 0 7.u. Quail 0 7.v. Other birds 0 0 0 0 0 0 0 0 0 0 0 0 4 4 7.w. Reptiles 0 7.x. Amphibians 0 7.y. Fish 0 7.z. TOTAL 42.721 1.866 0 0 0 0 0 0 15 0 0 0 7.463 52.065 EN 75 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates 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 12 0 0 0 0 0 0 0 0 0 0 0 223 235 8.b. Products/substances used or intended to be used mainly in agriculture 8.c. Products/substances used or intended to be used mainly in industry 8.d. Products/substances used or intended to be used mainly in the household 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 8.i. Other toxicological or safety evaluations 1.866 0 0 0 0 0 0 0 15 0 0 0 49.949 51.830 8.j. TOTAL 1.878 0 0 0 0 0 0 0 15 0 0 0 50.172 52.065 EN 76 EN GREECE Statistical data submitted The statistical data have been submitted by the “ΥΠΟΥΡΓΕΙΟ ΓΕΩΡΓΙΑΣ ΓΕΝΙΚΗ ∆/ΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ” (Ministry of Rural Development and Food, Directorate for Veterinary Care, Drugs & Practice). Comments of Greek authorities The legal basis for the collection of statistics on the number and use of vertebrate animals for experimental and other scientific purposes in Greece is provided by: • Presidential Decree No 160/91 (Government Gazette I 64) on the protection of animals used for experimental and other scientific purposes, in accordance with Council Directive 86/609/EEC, and • Law No 2015/92 (Government Gazette I 30) approving the European Convention on the protection of animals used for experimental and other scientific purposes. For the collection of statistics relating to 2008 use was made of the tables, data and glossary of terms set out in European Commission document EL/11/97/04100000 W00 - 24-6-1997. The Ministry of Rural Development and Food, Directorate-General for Veterinary Affairs, Directorate for Veterinary Care, Drugs & Practice sent them directly to the educational establishments (universities and technological colleges), research centres, healthcare institutions and businesses and pharmaceutical companies which use vertebrate animals for experimental and other scientific purposes. These documents were not sent to cosmetics manufacturers for the year in question, as our department was informed that no cosmetics company uses animals for experimental purposes in Greece. The total number of animals used in experiments in Greece in 2008 was 28021. Of these, 86,36% (24198 animals) were rodents (19,786 mice – accounting for 81,77%, 4,367 rats accounting for 18,05%, 45 guinea pigs - accounting for 0,18%), 32,82% of which were used to study fundamental biological characteristics, 15,2% for research and development of medical, dental and veterinary products and appliances, 0,24% to control the production and quality of medical and dental products and appliances, 31,67% for toxicological and other safety studies, 16,02% for diagnosing illnesses, 2,5% for education and training purposes and, finally, 1,52% for other purposes. Rabbits accounted for 5,34% of the animals used: (1,498 animals, of which 31 had already been used) of which 36,18% were used to study fundamental biological characteristics, 48,86% for research and development of medical, dental and veterinary products and appliances, 3,67% to control the production and quality of veterinary products and appliances, 2,67% for toxicological studies, 2,67% for diagnosing illnesses, 5,87% for education and training purposes and 0,06% for other purposes. Fish accounted for 4,28% of the animals used (1200 animals), and were used to study fundamental biological characteristics. EN 77 EN Pigs accounted for 2,26% of the animals used (624 animals) of which 14,58% were used to study fundamental biological characteristics, 47,27% for research and development of medical, dental and veterinary products and appliances, 2,24% to control the production and quality of medical and dental products and appliances, and 35,89% for education and training purposes. Amphibians accounted for 0,71% of the animals used (200 animals) of which 100% were used for education and training purposes. Other birds accounted for 0,31% of the animals used (88 animals), of which 57,95% were used to study fundamental biological characteristics, 34% for diagnosing illnesses, 6,81% for education and training purposes, and 1,13% for other purposes. Bovines accounted for 0,25% of the animals used (72 animals), and were used for education and training purposes. Sheep accounted for 0,4% of the animals used (68 animals) of which 51,47% were used for diagnosing illnesses, 47,05% for education and training purposes, and 1,47% for other purposes. Dogs accounted for 0,18% of the animals used (44 animals) of which 88,63% were used for research and development of medical, dental and veterinary products and appliances and 11,36% for education and training purposes. Goats accounted for 0,09% of the animals used (24 animals), of which 75% were used for diagnosing illnesses and 25% for education and training purposes Cats accounted for 0,01% of the animals used (4 animals), and were used for research and development of medical, dental and veterinary products and appliances. Finally, only one (1) equid was used, for education and training purposes. It is apparent from the above data that the two main categories of experiments conducted in Greece are on the one hand, research and development of medical, dental and veterinary products and appliances and on the other, the study of fundamental biological characteristics. It is apparent from the above data and from the tables that in 2008 the four categories of tests which used most animals were biological studies, followed by toxicological and other safety studies, research and development of medical, dental and veterinary products, and the diagnosis of illnesses. The main species used were rodents, fish, and rabbits. EN 78 EN 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) 19786 19493 206 87 1.b. Rats (Rattus norvegicus) 4367 4332 20 15 1.c. Guinea-Pigs (Cavia porcellus) 45 21 24 1.d. Hamsters (Mesocricetus ) 0 1.e. Other Rodents (other Rodentia) 1.f. Rabbits (Oryctolagus cuniculus) 1498 1467 31 1.g. Cats (Felis catus) 4 4 1.h. Dogs (Canis familiaris) 44 34 10 1.i. Ferrets (Mustela putorius furo) 0 1.j. Other Carnivores (other Carnivora) 1.k. Horses, donkeys and cross breds (Equidae) 1 1.l. Pigs (Sus) 624 1.m. Goats (Capra) 24 1.n. Sheep (Ovis) 68 1.o. Cattle (Bos) 72 1.p. Prosimians (Prosimia) 0 1.q. New World Monkeys (Ceboidea) 0 1.r. Old World Monkeys (Cercopithecoidea) 0 1.s. Apes (Hominoidea) 0 1.t. Other Mammals (other Mammalia) 1.u. Quail (Coturnix coturnix) 0 1.v. Other birds (other Aves) 88 1.w. Reptiles (Reptilia) 1.x. Amphibians (Amphibia) 200 1.y. Fish (Pisces) 1200 1.z. TOTAL 28021 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 EN 79 EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species 2.2 Biological studies of a fundamenta l 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 6274 2271 7197 3574 172 298 19786 2.b. Rats 1670 1408 60 468 264 427 70 4367 2.c. Guinea-Pigs 40 5 45 2.d. Hamsters 0 2.e. Other Rodents 0 2.f. Rabbits 542 732 55 40 40 88 1 1498 2.g. Cats 4 4 2.h. Dogs 39 5 44 2.i. Ferrets 0 2.j. Other Carnivores 0 2.k. Horses, donkeys and cross breds 1 1 2.l. Pigs 91 295 14 224 624 2.m. Goats 18 6 24 2.n. Sheep 35 32 1 68 2.o. Cattle 72 72 2.p. Prosimians 0 2.q. New World Monkeys 0 2.r. Old World Monkeys 0 2.s. Apes 0 2.t. Other Mammals 0 2.u. Quail 0 2.v. Other birds 51 30 6 1 88 2.w. Reptiles 0 2.x. Amphibians 200 200 2.y. Fish 1200 1200 2.z. TOTAL 9828 4749 74 55 7705 4001 1238 371 28021 EN 80 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 120 7077 7197 3.b. Rats 430 12 26 468 3.c. Guinea-Pigs 0 3.d. Hamsters 0 3.e. Other Rodents 0 3.f. Rabbits 40 40 3.g. Cats 0 3.h. Dogs 0 3.i. Ferrets 0 3.j. Other Carnivores 0 3.k. Horses, donkeys and cross breds 0 3.l. Pigs 0 3.m. Goats 0 3.n. Sheep 0 3.o. Cattle 0 3.p. Prosimians 0 3.q. New World Monkeys 0 3.r. Old World Monkeys 0 3.s. Apes 0 3.t. Other Mammals 0 3.u. Quail 0 3.v. Other birds 0 3.w. Reptiles 0 3.x. Amphibians 0 3.y. Fish 0 3.z. TOTAL 590 12 0 0 0 0 0 26 7077 7705 EN 81 EN 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 1838 1756 1196 2512 207 7509 4.b. Rats 570 447 40 1138 11 2206 4.c. Guinea-Pigs 40 40 4.d. Hamsters 0 4.e. Other Rodents 0 4.f. Rabbits 489 18 625 31 1163 4.g. Cats 0 4.h. Dogs 0 4.i. Ferrets 0 4.j. Other Carnivores 0 4.k. Horses, donkeys and cross breds 0 4.l. Pigs 237 122 359 4.m. Goats 18 18 4.n. Sheep 35 35 4.o. Cattle 0 4.p. Prosimians 0 4.q. New World Monkeys 0 4.r. Old World Monkeys 0 4.s. Apes 0 4.t. Other Mammals 0 4.u. Quail 0 4.v. Other birds 30 30 4.w. Reptiles 0 4.x. Amphibians 0 4.y. Fish 1000 200 1200 4.z. TOTAL 4134 2421 1236 4397 372 12560 EN 82 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 0 5.b. Rats 60 60 5.c. Guinea-Pigs 0 5.d. Hamsters 0 5.e. Other Rodents 0 5.f. Rabbits 55 55 5.g. Cats 0 5.h. Dogs 0 5.i. Ferrets 0 5.j. Other Carnivores 0 5.k. Horses, donkeys and cross breds 0 5.l. Pigs 14 14 5.m. Goats 0 5.n. Sheep 0 5.o. Cattle 0 5.p. Prosimians 0 5.q. New World Monkeys 0 5.r. Old World Monkeys 0 5.s. Apes 0 5.t. Other Mammals 0 5.u. Quail 0 5.v. Other birds 0 5.w. Reptiles 0 5.x. Amphibians 0 5.y. Fish 0 5.z. TOTAL 0 129 0 0 0 0 129 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 83 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 120 7077 7197 6.b. Rats 38 430 468 6.c. Guinea-Pigs 0 6.d. Hamsters 0 6.e. Other Rodents 0 6.f. Rabbits 40 40 6.g. Cats 0 6.h. Dogs 0 6.i. Ferrets 0 6.j. Other Carnivores 0 6.k. Horses, donkeys and cross breds 0 6.l. Pigs 0 6.m. Goats 0 6.n. Sheep 0 6.o. Cattle 0 6.p. Prosimians 0 6.q. New World Monkeys 0 6.r. Old World Monkeys 0 6.s. Apes 0 6.t. Other Mammals 0 6.u. Quail 0 6.v. Other birds 0 6.w. Reptiles 0 6.x. Amphibians 0 6.y. Fish 0 6.z. TOTAL 38 590 0 0 7077 0 7705 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 84 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 7077 120 7197 7.b. Rats 12 26 430 468 7.c. Guinea-Pigs 0 7.d. Hamsters 0 7.e. Other Rodents 0 7.f. Rabbits 40 40 7.g. Cats 0 7.h. Dogs 0 7.i. Ferrets 0 7.j. Other Carnivores 0 7.k. Horses, donkeys and cross breds 0 7.l. Pigs 0 7.m. Goats 0 7.n. Sheep 0 7.o. Cattle 0 7.p. Prosimians 0 7.q. New World Monkeys 0 7.r. Old World Monkeys 0 7.s. Apes 0 7.t. Other Mammals 0 7.u. Quail 0 7.v. Other birds 0 7.w. Reptiles 0 7.x. Amphibians 0 7.y. Fish 0 7.z. TOTAL 0 7077 12 0 0 0 0 0 0 26 0 0 590 7705 EN 85 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates 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 590 590 8.b. Products/substances used or intended to be used mainly in agriculture 12 12 8.c. Products/substances used or intended to be used mainly in industry 0 8.d. Products/substances used or intended to be used mainly in the household 0 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 0 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 0 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 0 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 26 26 8.i. Other toxicological or safety evaluations 7077 7077 8.j. TOTAL 0 7077 12 0 0 0 0 0 0 26 0 0 590 7705 EN 86 EN SPAIN Statistical data submitted The Statistical data have been provided by the: "Ministerio de Agricultura, Pesca y Alimentación, Subdirección General de Ordenacion de explotaciones" (Ministry of Agriculture, Fisheries and Food, Sub-directorate of Management of Developments). Comments of Spanish authorities The statistical information was put together by the Ministry of the Environment and the Rural and Marine Environment (MARM) on the basis of data it had collected itself or received from the individual Autonomous Communities. 220 establishments are registered for 2009. The number of establishments has remained at around the same level for the past few years. The MARM is currently changing its system for registering holdings, suppliers and users of animals for scientific purposes so that they will be included in the REGA database (register of livestock holdings). As regards the trend in the past few years in the number of animals used within the scope of Directive 86/609/EEC, while the total has gone down, there has been an increase in the use for research purposes of 'non-traditional' species, such as farm animals. The tables on the use of animals and the possible regulatory requirements show an increase in the number of animals used in the production and quality control of medical, dental or veterinary products, greater pressure from EU regulation and a fall in the use of animals to meet the requirements of 'other rules'. Finally, there has been a fall in the number of animals used for training purposes. EN 87 EN 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) 543680 467820 67595 41 8224 1.b. Rats (Rattus norvegicus) 175325 147505 27397 0 423 275 1.c. Guinea-Pigs (Cavia porcellus) 12620 9601 3019 0 0 1.d. Hamsters (Mesocricetus ) 1262 1138 113 0 11 1.e. Other Rodents (other Rodentia) 251 1.f. Rabbits (Oryctolagus cuniculus) 19626 18651 873 0 102 396 1.g. Cats (Felis catus) 100 73 0 0 27 0 1.h. Dogs (Canis familiaris) 1046 990 43 0 13 1 1.i. Ferrets (Mustela putorius furo) 287 14 0 0 273 0 1.j. Other Carnivores (other Carnivora) 5 1.k. Horses, donkeys and cross breds (Equidae) 90 1.l. Pigs (Sus) 15121 902 1.m. Goats (Capra) 372 20 1.n. Sheep (Ovis) 2386 3 1.o. Cattle (Bos) 1091 1.p. Prosimians (Prosimia) 0 0 0 0 0 1.q. New World Monkeys (Ceboidea) 8 0 8 0 0 1.r. Old World Monkeys (Cercopithecoidea) 517 362 152 3 0 1.s. Apes (Hominoidea) 0 0 0 0 0 1.t. Other Mammals (other Mammalia) 28 1.u. Quail (Coturnix coturnix) 138 81 0 0 57 1.v. Other birds (other Aves) 52104 1.w. Reptiles (Reptilia) 1.x. Amphibians (Amphibia) 704 1.y. Fish (Pisces) 71098 1.z. TOTAL 897859 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 EN 88 EN 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 268703 136072 16012 19904 63052 20338 6665 12934 543680 2.b. Rats 63513 65305 2311 9750 8810 11256 8305 6075 175325 2.c. Guinea-Pigs 149 4537 868 3370 3566 102 28 0 12620 2.d. Hamsters 564 409 0 0 156 119 14 0 1262 2.e. Other Rodents 206 10 0 0 0 0 0 35 251 2.f. Rabbits 1247 3658 879 5318 6765 488 232 1039 19626 2.g. Cats 48 17 0 4 0 0 0 31 100 2.h. Dogs 65 389 0 176 349 6 44 17 1046 2.i. Ferrets 14 241 0 0 32 0 0 0 287 2.j. Other Carnivores 5 0 0 0 0 0 0 0 5 2.k. Horses, donkeys and cross breds 0 0 0 90 0 0 0 0 90 2.l. Pigs 841 2428 0 903 4925 329 2013 3682 15121 2.m. Goats 52 37 27 0 0 0 125 131 372 2.n. Sheep 186 1070 50 812 78 44 124 22 2386 2.o. Cattle 154 472 0 304 58 0 103 0 1091 2.p. Prosimians 0 0 0 0 0 0 0 0 0 2.q. New World Monkeys 8 0 0 0 0 0 0 0 8 2.r. Old World Monkeys 16 74 0 0 427 0 0 0 517 2.s. Apes 0 0 0 0 0 0 0 0 0 2.t. Other Mammals 0 0 0 16 0 12 0 0 28 2.u. Quail 57 57 0 0 24 0 0 0 138 2.v. Other birds 664 4113 344 4991 35297 30 42 6623 52104 2.w. Reptiles 0 0 0 0 0 0 0 0 0 2.x. Amphibians 661 0 0 0 0 0 13 30 704 2.y. Fish 52521 5780 0 0 940 400 152 11305 71098 2.z. TOTAL 389674 224669 20491 45638 124479 33124 17860 41924 897859 EN 89 EN 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 contaminents in the general environment which do not appear in other columns 3.10 Other toxicological or safety evaluations 3.11 Total 3.a. Mice 19644 0 0 0 126 0 1023 557 41702 63052 3.b. Rats 6570 170 296 120 124 0 0 0 1530 8810 3.c. Guinea-Pigs 3530 0 32 0 0 0 0 0 4 3566 3.d. Hamsters 156 0 0 0 0 0 0 0 0 156 3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 3.f. Rabbits 6298 43 272 42 110 0 0 0 0 6765 3.g. Cats 0 0 0 0 0 0 0 0 0 0 3.h. Dogs 254 52 0 0 0 0 0 0 43 349 3.i. Ferrets 32 0 0 0 0 0 0 0 0 32 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 791 0 0 0 0 0 4134 0 0 4925 3.m. Goats 0 0 0 0 0 0 0 0 0 0 3.n. Sheep 78 0 0 0 0 0 0 0 0 78 3.o. Cattle 58 0 0 0 0 0 0 0 0 58 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 427 0 0 0 0 0 0 0 0 427 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 24 0 0 0 0 0 0 0 24 3.v. Other birds 1268 0 0 0 0 0 34029 0 0 35297 3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 3.y. Fish 0 0 504 0 0 0 0 286 150 940 3.z. TOTAL 39106 289 1104 162 360 0 39186 843 43429 124479 EN 90 EN 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 15692 36425 85628 48186 7331 193262 4.b. Rats 11159 33110 2520 58447 586 105822 4.c. Guinea-Pigs 0 234 60 4687 298 5279 4.d. Hamsters 51 103 349 68 175 746 4.e. Other Rodents 0 231 0 10 0 241 4.f. Rabbits 6 6 0 1989 2541 4542 4.g. Cats 4 9 0 3 0 16 4.h. Dogs 47 0 45 88 94 274 4.i. Ferrets 0 0 0 241 0 241 4.j. Other Carnivores 27 0 0 4 5 36 4.k. Horses, donkeys and cross breds 0 0 0 0 86 86 4.l. Pigs 352 5 3 906 2592 3858 4.m. Goats 20 0 0 8 0 28 4.n. Sheep 26 36 24 170 873 1129 4.o. Cattle 0 0 0 0 606 606 4.p. Prosimians 0 0 0 3 0 3 4.q. New World Monkeys 0 3 0 0 0 3 4.r. Old World Monkeys 0 59 0 15 8 82 4.s. Apes 0 0 0 0 0 0 4.t. Other Mammals 0 0 0 0 12 12 4.u. Quail 0 0 0 57 0 57 4.v. Other birds 0 0 0 20 7325 7345 4.w. Reptiles 0 0 0 0 0 0 4.x. Amphibians 0 5 130 382 0 517 4.y. Fish 200 500 485 23378 4866 29429 4.z. TOTAL 27584 70726 89244 138662 27398 353614 EN 91 EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus species 5.1 Species 5.2 National legislation specific to a single EC Member State 1) 5.3 EC legislation including European Pharmacopoeia (requirements) 5.4 Member Country of Council of Europe (but not EC) legislation 2) 5.5 Other legislation 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 5.7 No regulatory requirements 5.8 Total 5.a. Mice 0 33234 0 403 0 2279 35916 5.b. Rats 0 11278 0 655 128 0 12061 5.c. Guinea-Pigs 0 3344 0 731 0 163 4238 5.d. Hamsters 0 0 0 0 0 0 0 5.e. Other Rodents 0 0 0 0 0 0 0 5.f. Rabbits 0 5337 0 0 16 844 6197 5.g. Cats 4 0 0 0 0 0 4 5.h. Dogs 176 0 0 0 0 0 176 5.i. Ferrets 0 0 0 0 0 0 0 5.j. Other Carnivores 0 0 0 0 0 0 0 5.k. Horses, donkeys and cross breds 0 90 0 0 0 0 90 5.l. Pigs 0 507 0 0 130 266 903 5.m. Goats 0 27 0 0 0 0 27 5.n. Sheep 0 749 54 0 0 59 862 5.o. Cattle 26 278 0 0 0 0 304 5.p. Prosimians 0 0 0 0 0 0 0 5.q. New World Monkeys 0 0 0 0 0 0 0 5.r. Old World Monkeys 0 0 0 0 0 0 0 5.s. Apes 0 0 0 0 0 0 0 5.t. Other Mammals 0 16 0 0 0 0 16 5.u. Quail 0 0 0 0 0 0 0 5.v. Other birds 0 3496 0 1321 0 518 5335 5.w. Reptiles 0 0 0 0 0 0 0 5.x. Amphibians 0 0 0 0 0 0 0 5.y. Fish 0 0 0 0 0 0 0 5.z. TOTAL 206 58356 54 3110 274 4129 66129 Examples: 5.2 – France is testing due to a UK (or FR) specific requirement Note: columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 5.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 5.4 - Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 5.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 5.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 92 EN TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory requirements versus species 6.1 Species 6.2 National legislation specific to a single EC Member State 1) 6.3 EC legislation including European Pharmacopoeia (requirements) 6.4 Member Country of Council of Europe (but not EC) legislation 2) 6.5 Other legislation 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 6.7 No regulatory requirements 6.8 Total 6.a. Mice 1147 18053 30 0 40120 3702 63052 6.b. Rats 290 2934 0 244 4286 1056 8810 6.c. Guinea-Pigs 0 434 84 288 2752 8 3566 6.d. Hamsters 80 76 0 0 0 0 156 6.e. Other Rodents 0 0 0 0 0 0 0 6.f. Rabbits 100 764 0 218 5547 136 6765 6.g. Cats 0 0 0 0 0 0 0 6.h. Dogs 0 30 0 0 284 35 349 6.i. Ferrets 0 32 0 0 0 0 32 6.j. Other Carnivores 0 0 0 0 0 0 0 6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 6.l. Pigs 0 329 0 0 4585 11 4925 6.m. Goats 0 0 0 0 0 0 0 6.n. Sheep 0 28 0 0 44 6 78 6.o. Cattle 0 0 0 0 58 0 58 6.p. Prosimians 0 0 0 0 0 0 0 6.q. New World Monkeys 0 0 0 0 0 0 0 6.r. Old World Monkeys 0 75 0 0 352 0 427 6.s. Apes 0 0 0 0 0 0 0 6.t. Other Mammals 0 0 0 0 0 0 0 6.u. Quail 24 0 0 0 0 0 24 6.v. Other birds 0 1 0 0 34029 1267 35297 6.w. Reptiles 0 0 0 0 0 0 0 6.x. Amphibians 0 0 0 0 0 0 0 6.y. Fish 504 150 0 0 286 0 940 6.z. TOTAL 2145 22906 114 750 92343 6221 124479 Examples: 6.2 – France is testing due to a UK (or FR) specific requirement Note: columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 6.3 - UK is testing according to EC legislation not to the body which has issued the actual test method, guideline or protocol. 6.4 – Spain is testing due to a Norwegian requirement Example: a test required by French legislation and carried out in Belgium according to an 6.5 – Poland is testing due to a US specific requirement ISO protocol must be coded as a national (FR) legislative requirement and be 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) entered into column 6.2 in the tables submitted by Belgium. Footnotes: 1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine EN 93 EN TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus species 7.1 Species 7.2 Acute and sub-acute toxicity testing methods (including limit test) 7.3 Skin irritation 7.4 Skin sensitisatio n 7.5 Eye irritation 7.6 Subchronic and chronic toxicity 7.7 Carcino- genicity 7.8 Develop- mental toxicity 7.9 Muta- genicit y 7.10 Repro- ductive toxicity 7.11 Toxicity to aquatic vertebrates not included in other columns 7.12 Other 7.13 Total 7.2.1. LD50, LC50 7.2.2 Other lethal methods 7.2.3 Non lethal clinical signs methods 7.a. Mice 6991 39161 908 56 298 0 840 0 0 0 0 0 14798 63052 7.b. Rats 246 398 949 290 76 0 2593 0 0 0 437 0 3821 8810 7.c. Guinea-Pigs 0 303 24 0 326 0 0 0 0 0 0 0 2913 3566 7.d. Hamsters 16 0 0 0 0 0 80 0 0 0 0 0 60 156 7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.f. Rabbits 22 0 143 397 0 248 0 0 94 0 69 0 5792 6765 7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.h. Dogs 0 0 0 0 0 0 276 0 0 0 0 0 73 349 7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 32 32 7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.l. Pigs 0 0 0 40 0 0 119 0 0 0 0 0 4766 4925 7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 78 78 7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 58 58 7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.r. Old World Monkeys 18 0 0 0 0 0 405 0 0 0 0 0 4 427 7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.u. Quail 0 24 0 0 0 0 0 0 0 0 0 0 0 24 7.v. Other birds 0 0 0 0 0 0 0 0 0 0 0 0 35297 35297 7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7.y. Fish 0 0 0 0 0 0 0 213 504 0 0 0 223 940 7.z. TOTAL 7293 39886 2024 783 700 248 4313 213 598 0 506 0 67915 124479 EN 94 EN TABLE 8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types of tests versus products 8.1 Products 8.2 Acute and sub-acute toxicity testing methods (including limit test) 8.3 Skin irritation 8.4 Skin sensitisatio n 8.5 Eye irritation 8.6 Sub- chronic and chronic toxicity 8.7 Carcino genicity 8.8 Develop- mental toxicity 8.9 Muta- genicit y 8.10 Repro- ductive toxicity 8.11 Toxicity to aquatic vertebrates 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 2082 2797 1788 416 602 62 3942 94 506 26817 39106 8.b. Products/substances used or intended to be used mainly in agriculture 39 105 141 4 289 8.c. Products/substances used or intended to be used mainly in industry 28 236 75 98 113 50 504 1104 8.d. Products/substances used or intended to be used mainly in the household 139 23 162 8.e. Products/substances used or intended to be used mainly as cosmetics or toiletries 60 202 48 50 360 8.f. Products/substances used or intended to be used mainly as additives in food for human consumption 0 8.g. Products/substances used or intended to be used mainly as additives in food for animal consumption 1023 38163 39186 8.h. Potential or actual contaminants in the general environment which do not appear in other columns 557 213 73 843 8.i. Other toxicological or safety evaluations 4594 35797 180 2858 43429 8.j. TOTAL 7293 39886 2024 783 700 248 4313 213 598 0 506 0 67915 124479