COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
Date: 2013-12-05
Institutions: European Commission
Subjects: EU statistics, animal experimentation, animal welfare, data collection, protection of animals, scientific research

EUROPEAN 
COMMISSION 

Brussels, 19.3.2014  
SWD(2013) 497 final/2 

PART 4/5 

CORRIGENDUM: 
Annule et remplace le document SWD (2013) 497 final du 05.12.2013 
Concerne:  les données du tableau nr 1, page 16 

COMMISSION STAFF WORKING DOCUMENT 

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

{COM(2013) 859 final}

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COMMISSION STAFF WORKING DOCUMENT 

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

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PART B III: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE 
MEMBER STATES

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TABLE OF CONTENTS 

FRANCE.....................................................................................................................................6 

ITALY.......................................................................................................................................15 

CYPRUS ...................................................................................................................................24 

LATVIA....................................................................................................................................29 

LITHUANIA.............................................................................................................................35 

LUXEMBOURG ......................................................................................................................44 

HUNGARY...............................................................................................................................48 

MALTA ....................................................................................................................................57 

THE NETHERLANDS.............................................................................................................60 

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FRANCE  

Statistical data submitted 

The  statistical  data  were  submitted  by  the  'Ministère  de  l’Enseignement  Supérieur  et  de  la 
Recherche' (Ministry for Higher Education and Research). 

Comments of the French authorities 

This study was realized by the IsoCL Company (formerly Eficom Marketudes) for the Research and 
Higher Education Ministry. 

In France, 2.2 million animals were used for scientific purposes in 2010, whereas 2.3 million were 
used  in  2007.  It  appears  that  the  number  of  animals  used  showed  a  steady  state  since  1999  with 
about  2.2  million.  It  represents  a  decrease  of  40%  in  comparison  with  the  figures  of  the  first 
statistical study in 1990.  

1,326,274 of the animals used were mice (60%). Fish accounted for 354,039 (16%) of the animals 
used, rats for 252,589 (11%), and rabbits for 125,913 (6%). 

Cool-blooded  animals  (fish,  amphibian  and  reptiles)  accounted  for  357,392  (16%)  of  the  animals 
used. 

Non-human primates accounted for 1,810 animals, 0.08% of the animals used, a reduction of 34% 
compared with 2007. Most of the non-human primates used were cercopithecoidea (86%) and more 
precisely Macaca cynomolgus (70%). Similarly to previous years, no apes were used for scientific 
purposes. 

Since  2007,  rodents  (1,622,840)  showed  a  reduction  of  20%,  whereas  rabbits  (125,913)  and  fish 
(354,039) presented an increase of 31% and 1650%, respectively. 

Concerning the purpose, 1,103,214 animals (50%) were used for research purposes: 598,532 animals 
(27%)  were  used  for  fundamental  biology  studies  and  504,682  (23%)  were  used  for  research  and 
development  and  production  and  quality  control  relating  to  human  medicine,  dentistry  and 
veterinary  medicine.  403,426  animals  (18%)  were  used  for  production  and  quality  control  of 
products and devices for human medicine and dentistry. 

Toxicological or other safety evaluations used 78,041 animals (3.5%). 

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

1.1 
Species 

Origin versus 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 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

1 326 274 
252 589 
35 543 
8 210 
224 
125 913 
569 
3 032 
351 
0 
373 
7 364 
710 
5 491 
2 362 
83 
163 
1 564 
0 
2 
122 
71 821 
74 
3 279 
354 039 
2 200 152 

1 193 758 
244 910 
31 181 
6 805 
0 
125 912 
479 
1 840 
0 
0 
0 
0 
0 
0 
0 
83 
160 
666 
0 
0 
122 
0 
0 
0 

1 605 916 

20 682 
674 
3 857 
243 
0 
0 
69 
373 
0 
0 
0 
0 
0 
0 
0 
0 
3 
63 
0 
0 
0 
0 
0 
0 

25 964 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 
39 110 
1 030 
410 
0 
0 
1 
0 
129 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

40 680 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

72 724 
5 975 
95 
1 162 
0 
0 
21 
690 
351 
0 
0 
0 
0 
0 
0 
0 
0 
835 
0 
0 
0 
0 
0 
0 

81 853 

914 
2 132 
0 
0 
0 
1 102 
130 
825 
72 
0 
0 
0 
0 
0 
0 
83 
156 
514 
0 
0 
0 
0 
0 
0 

5 928 

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list 

of those countries has to be used when filling in this column. 

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

Note 3: 

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

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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.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

547 843 
45 681 
464 
567 
118 
1 343 
40 
125 
36 
0 

3 

136 
78 
18 
3 
83 
31 
110 
0 
2 
122 
294 
74 
1 016 
345 
598 532 

EN 

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) 
347 485 
130 052 
4 816 
3 361 
100 
6 922 
317 
1 012 
288 
0 

96 

1 759 
35 
510 
443 
0 
125 
484 
0 
0 
0 
3 818 
0 
12 
3 047 
504 682 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

22 074 
41 799 
2 609 
542 
0 
3 733 
68 
1 483 
20 
0 

0 

245 
0 
161 
239 
0 
6 
811 
0 
0 
0 
45 
0 
0 
4 206 
78 041 

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 

312 483 
3 638 
25 829 
0 
0 
53 613 
0 
0 
4 
0 

94 

0 
0 
10 
0 
0 
0 
86 
0 
0 
0 
7 669 
0 
0 
0 
403 426 

13 527 
163 
750 
1 416 
0 
1 015 
132 
375 
0 
0 

5 

681 
0 
808 
108 
0 
0 
0 
0 
0 
0 
38 277 
0 
0 
0 
57 257 

8 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

2 879 
152 
0 
0 
0 
8 
0 
0 
0 
0 

0 

4 
7 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 050 

10 722 
10 105 
75 
80 
6 
424 
0 
6 
3 
0 

10 

1 951 
0 
5 
19 
0 
0 
0 
0 
0 
0 
58 
0 
2 238 
418 
26 120 

69 261 
20 999 
1 000 
2 244 
0 
58 855 
12 
31 
0 
0 

165 

2 588 
590 
3 979 
1 550 
0 
1 
73 
0 
0 
0 
21 660 
0 
13 
346 023 
529 044 

1 326 274 
252 589 
35 543 
8 210 
224 
125 913 
569 
3 032 
351 
0 

373 

7 364 
710 
5 491 
2 362 
83 
163 
1 564 
0 
2 
122 
71 821 
74 
3 279 
354 039 
2 200 152 

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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.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

9 604 
15 019 
914 
254 
0 
1 043 
68 
693 
20 
0 
0 
112 
0 
0 
233 
0 
0 
242 
0 
0 
0 
45 
0 
0 
86 
28 333 

3 122 
5 979 
750 
73 
0 
397 
0 
88 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 049 
12 458 

1 765 
4 235 
150 
21 
0 
212 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6 383 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

EN 

0 
40 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
40 

9 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
52 
70 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
122 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
0 
54 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
21 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
81 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

872 
756 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 
0 
140 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 771 

6 659 
15 646 
795 
194 
0 
2 081 
0 
702 
0 
0 
0 
130 
0 
0 
0 
0 
6 
569 
0 
0 
0 
0 
0 
0 
2 071 
28 853 

3.11 
Total 

22 074 
41 799 
2 609 
542 
0 
3 733 
68 
1 483 
20 
0 
0 
245 
0 
161 
239 
0 
6 
811 
0 
0 
0 
45 
0 
0 
4 206 
78 041 

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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.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
Pigs 
4.l. 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

94 767 
38 018 
652 
506 
0 
1 438 
0 
68 
0 
0 
0 
544 
0 
170 
4 
0 
0 
343 
0 
0 
0 
0 
0 
36 
0 
136 546 

142 675 
78 662 
281 
0 
0 
184 
19 
41 
0 
0 
0 
29 
0 
0 
0 
58 
0 
12 
0 
0 
0 
0 
0 
40 
0 
222 001 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 
178 443 
4 392 
26 
72 
0 
79 
0 
1 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
0 
0 
183 015 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

261 176 
53 274 
4 028 
1 109 
80 
6 483 
44 
286 
273 
0 
0 
549 
31 
69 
3 
25 
156 
194 
0 
0 
122 
299 
24 
67 
3 127 
331 419 

221 146 
1 539 
293 
2 241 
138 
89 
294 
741 
51 
0 
99 
777 
89 
289 
439 
0 
0 
45 
0 
0 
0 
3 813 
50 
885 
265 
233 283 

4.7 
Total 

898 207 
175 885 
5 280 
3 928 
218 
8 273 
357 
1 137 
324 
0 
99 
1 899 
120 
528 
446 
83 
156 
594 
0 
2 
122 
4 112 
74 
1 028 
3 392 
1 106 264 

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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.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

5.2  
National legislation 
specific to a single EC 
Member State 
1) 
24 926 
3 282 
0 
0 
0 
488 
0 
118 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
28 814 

5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 
49 841 
243 
3 064 
1 416 
0 
27 006 
132 
257 
0 
0 
99 
681 
0 
818 
108 
0 
0 
0 
0 
0 
0 
45 916 
0 
0 
0 
129 581 

5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 
2 162 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 162 

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 

0 
0 
280 
0 
0 
0 
0 
0 
,  
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
280 

223 452 
274 
23 235 
0 
0 
2 338 
0 
0 
4 
0 
0 
0 
0 
0 
0 
0 
0 
86 
0 
0 
0 
0 
0 
0 
0 
249 389 

25 629 
2 
0 
0 
0 
24 796 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
30 
0 
0 
0 
50 457 

326 010 
3 801 
26 579 
1 416 
0 
54 628 
132 
375 
4 
0 
99 
681 
0 
818 
108 
0 
0 
86 
0 
0 
0 
45 946 
0 
0 
0 
460 683 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 - Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Swiss  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep.,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

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  

11 

EN 

Footnotes: 

EN 

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

Regulatory requirements versus species 

6.8 
Total 

6.1 
Species 

6.5 
Other legislation 

6.7 
No regulatory 
requirements 

6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
TOTAL 
6.z. 
Examples: 

6.2  
National legislation 
specific to a single EC 
Member State 
1) 
7 193 
10 268 
610 
21 
0 
873 
0 
270 
0 
0 
0 
0 
0 
21 
6 
0 
0 
170 
0 
0 
0 
0 
0 
0 
0 
19 432 

6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 
3 680 
3 372 
954 
62 
0 
684 
0 
28 
0 
0 
0 
0 
0 
0 
8 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8 788 
6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Norwegian requirement 
6.5 – Poland is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Swiss  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep.,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 
0 
162 
0 
0 
0 
250 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
412 

22 074 
41 799 
2 609 
542 
0 
3 733 
68 
1 483 
20 
0 
0 
245 
0 
161 
239 
0 
6 
811 
0 
0 
0 
45 
0 
0 
4 206 
78 041 

5 029 
16 064 
163 
285 
0 
469 
68 
757 
20 
0 
0 
125 
0 
0 
225 
0 
6 
270 
0 
0 
0 
45 
0 
0 
2 049 
25 575 

4 092 
9 058 
745 
174 
0 
1 336 
0 
428 
0 
0 
0 
120 
0 
0 
0 
0 
0 
348 
0 
0 
0 
0 
0 
0 
2 071 
18 372 

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

2 080 
2 875 
137 
0 
0 
121 
0 
0 
0 
0 
0 
0 
0 
140 
0 
0 
0 
23 
0 
0 
0 
0 
0 
0 
86 
5 462 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

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  

12 

EN 

Footnotes: 

EN 

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

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 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

364 
102 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
466 

1 593 
2 195 
13 
0 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 801 

7.2.3 
Non lethal 
clinical signs 
methods 
2 575 
2 652 
0 
0 
0 
260 
0 
78 
0 
0 

0 

15 
0 
0 
0 
0 
0 
31 
0 
0 
0 
0 
0 
0 
86 
5 697 

28 
0 
0 
0 
0 
348 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
376 

EN 

2 307 
0 
1 130 
0 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 437 

13 

0 
0 
0 
0 
0 
295 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
295 

5 996 
10 494 
0 
265 
0 
16 
0 
563 
0 
0 

0 

0 
0 
0 
0 
0 
0 
216 
0 
0 
0 
0 
0 
0 
0 
17 550 

2 226 
1 273 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 499 

702 
2 579 
0 
0 
0 
424 
0 
0 
0 
0 

220 
1 633 
0 
0 
0 
0 
0 
0 
0 
0 

0 
1 089 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 705 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 853 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 089 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 049 
2 049 

6 063 
19 782 
1 466 
277 
0 
2 390 
68 
842 
20 
0 

22 074 
41 799 
2 609 
542 
0 
3 733 
68 
1 483 
20 
0 

0 

0 

230 
0 
161 
239 
0 
6 
564 
0 
0 
0 
45 
0 
0 
2 071 
34 224 

245 
0 
161 
239 
0 
6 
811 
0 
0 
0 
45 
0 
0 
4 206 
78 041 

EN 

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

8.1 
Products 

Types of tests versus 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 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.12 
Other 

8.13 
Total 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

226 

1 053 

5 657 

85 

864 

40 

8 426 

1 701 

1 120 

1 330 

447 

0 

7 384 

28 333 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

0 

0 

0 

0 

0 

0 

0 

240 

466 

1 596 

211 

0 

0 

70 

0 

153 

718 

0 

0 

0 

40 

0 

0 

0 

0 

160 

750 

144 

5 085 

1 798 

664 

70 

142 

2 049 

0 

12 458 

116 

1 823 

96 

0 

0 

0 

0 

0 

15 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 267 

0 

0 

0 

0 

0 

15 

2 772 

0 

0 

0 

0 

0 

0 

0 

840 

371 

0 

0 

0 

0 

0 

0 

0 

0 

54 

28 

0 

0 

0 

0 

0 

0 

1 081 

0 

500 

0 

0 

0 

0 

0 

0 

0 

2 926 

6 383 

0 

0 

0 

40 

52 

122 

27 

81 

323 

1 771 

23 512 

28 853 

3 801 

5 697 

376 

3 437 

295 

17 550 

3 499 

3 705 

1 853 

1 089 

2 049 

34 224 

78 041 

EN 

14 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ITALY  

Statistical data submitted  

The statistical data were submitted by Ministry of Health, Directorate General for Animal Health and 
Veterinary Medicinal Products, Office VI, Animal Welfare. 

Comments of the Italian authorities  

The  data  collected  have  been  used  for  the  ‘EU  harmonised  statistical  tables’  produced  by  the 
competent national EU authorities for 1997. 

In general the trend of an overall decrease in the numbers of the animals used for experiments has been 
confirmed and from 1999 the numbers have been consistently under 1 million animals. 

This said, there has been a significant increase in percentage terms in the use of mice (+ 2.01) and fish 
(+ 5.01) with regard to 2008. 

The tables also show data on the animals used for in vitro studies (euthanized to remove organs, tissues 
and cells). 

88.99 %       of the species of animals used were rodents or rabbits. 

53.78 %      of animals were used in basic biological studies. 

33.87 %      of animals were used for research and development, for the production and quality control 

of products and appliances for human medicine, orthodontics and veterinary medicine. 

7.82 %        of animals were used in toxicological studies. 

4.53 %        of animals were used to diagnose illnesses, for teaching and other purposes. 

In  general  a  decrease  has  been  noted  in  the  number  of  animals  used  for  the  production  and  quality 
control of products and appliances for human medicine, orthodontics and veterinary medicine and for 
toxicological studies (- 4.22% with regard to 2008). 

Article 24 of Directive 86/609/EEC, which was transposed into Italian law with Legislative Decree No 
116/92, has allowed the introduction of stricter measures which concern, in particular, the use of non-
human primates, dogs and cats as stipulated in Article 3(2) of the above-mentioned Legislative Decree: 
'as regards non-human primates, dogs and cats, the authorisation referred to in Article 8(1)(b) is 
also required.' 

However  the  use  of  non-human  primates,  dogs  and  cats  is  permitted  only  after  obtaining  specific 
prior authorisation from the Ministry of Health. 

All  this  has  resulted  in  non-human  primates,  dogs  and  cats  accounting  overall  for  0.11%  of  the  total 
animals used. 

EN 

15 

   EN 

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

Origin versus species 

           1.1   Spieces        

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.b.     Rats (Rattus norvegicus) 
1.c.     Guinea-Pigs (Cavia porcellus) 
1.d.     Hamsters (Mesocricetus ) 
1.e.     Other Rodents (other Rodentia) 
1.f.     Rabbits (Oryctolagus cuniculus) 
1.g.     Cats (Felis catus) 
1.h.     Dogs (Canis familiaris) 
1.i.      Ferrets (Mustela putorius furo) 
1.j.     Other Carnivores (other Carnivora) 
1.k.    Horses, donkeys and cross breds (Equidae) 
1.l.     Pigs (Sus) 
1.m.   Goats (Capra) 
1.n.    Sheep (Ovis) 
1.o.    Cattle (Bos) 
1.p.     Prosimians (Prosimia) 
1.q.     New World Monkeys (Ceboidea) 
1.r.     Old World Monkeys (Cercopithecoidea) 
1.s.    Apes (Hominoidea) 
1.t.     Other Mammals (other Mammalia) 
1.u.    Quail (Coturnix coturnix) 
1.v.    Other birds (other Aves) 
1.w.    Reptiles (Reptilia) 
1.x.     Amphibians (Amphibia) 
1.y.     Fish (Pisces) 

1.z.     TOTAL 

515946 
155136 
13784 
517 
1946 
8392 
0 
408 
0 
0 
34 
2486 
34 
243 
27 
0 
79 
371 
0 
184 
4 
29305 
239 
894 
51786 

781815 

486030 
153134 
11155 
517 

7847 
0 
214 
0 

0 
68 
40 
0 

4 

13639 
1067 
2629 
0 

545 
0 
154 
0 

0 
11 
291 
0 

0 

117 
0 
0 
0 

0 
0 
0 
0 

0 
0 
2 
0 

0 

16160 
935 
0 
0 

0 
0 
40 
0 

0 
0 
38 
0 

0 

726 
0 
26 
0 

0 
43 
18 
0 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the Council  of  Europe which,  at  the  beginning  of  the  reporting period,  are Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

16 

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.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

307552 
60920 
1206 
327 
92 
556 
0 
0 
0 
0 

23 
319 
3 
108 
5 
0 
0 
19 
0 
184 
4 
3694 
238 
894 
44307 
420451 

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) 

112340 
23858 
2812 
28 
493 
398 
0 
49 
0 
0 

0 
350 
3 
109 
0 
0 
68 
55 
0 
0 
0 
664 
0 
0 
1660 
142887 

EN 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

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) 

29226 
14109 
6531 
161 
0 
1918 
0 
359 
0 
0 

0 
453 
0 
18 
2 
0 
11 
262 
0 
0 
0 
4124 
0 
0 
3986 
61160 

25026 
857 
21 
0 
1361 
161 
0 
0 
0 
0 

8 
1 
28 
0 
0 
0 
0 
0 
0 
0 
0 
956 
0 
0 
0 
28419 

25 
639 
0 
0 
0 
0 
0 
0 
0 
0 

0 
473 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1137 

4907 
550 
25 
1 
0 
19 
0 
0 
0 
0 

3 
43 
0 
8 
0 
0 
0 
0 
0 
0 
0 
84 
1 
0 
233 
5874 

515946 
155136 
13784 
517 
1946 
8392 
0 
408 
0 
0 

34 
2486 
34 
243 
27 
0 
79 
371 
0 
184 
4 
29305 
239 
894 
51786 
781815 

35049 
53323 
2671 
0 
0 
4681 
0 
0 
0 
0 

0 
7 
0 
0 
0 
0 
0 
35 
0 
0 
0 
5 
0 
0 
0 
95771 

1821 
880 
518 
0 
0 
659 
0 
0 
0 
0 

0 
840 
0 
0 
20 
0 
0 
0 
0 
0 
0 
19778 
0 
0 
1600 
26116 

17 

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.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

5390 
10041 
5992 
153 
0 
1812 
0 
359 
0 
0 
0 
309 
0 
18 
0 
0 
11 
262 
0 
0 
0 
3620 
0 
0 
310 
28277 

0 
603 
468 
0 
0 
69 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1140 

90 
2228 
0 
0 
0 
21 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1866 
4205 

0 
0 
0 
8 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
0 
311 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
311 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
160 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
144 
0 
0 
0 
0 
0 
0 
0 
0 
0 
504 
0 
0 
0 
808 

3.11 
Total 

3.10 
Other toxico-
logical or 
safety 
evaluations 

3.9 
Potential or 
actual 
contaminants in 
the general 
environment 
which do not 
appear in other 
columns 

0 
0 
0 
0 
0 
4 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1810 
1814 

23586 
926 
71 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
24597 

29226 
14109 
6531 
161 
0 
1918 
0 
359 
0 
0 
0 
453 
0 
18 
2 
0 
11 
262 
0 
0 
0 
4124 
0 
0 
3986 
61160 

EN 

18 

EN 

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

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 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
Pigs 
4.l. 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

17852 
3670 
58 
28 
0 
122 
0 
15 
0 
0 
0 
73 
0 
14 
0 
0 
0 
4 
0 
0 
0 
0 
0 
0 
0 
21836 

53875 
27783 
376 
90 
0 
43 
0 
24 
0 
0 
0 
0 
0 
0 
0 
0 
57 
10 
0 
0 
0 
0 
0 
41 
0 
82299 

88910 
5572 
0 
0 
0 
3 
0 
140 
0 
0 
0 
9 
0 
2 
0 
0 
0 
42 
0 
0 
0 
0 
0 
0 
0 
94678 

124413 
18448 
3330 
158 
1197 
545 
0 
82 
0 
0 
0 
165 
0 
59 
0 
0 
11 
50 
0 
0 
0 
0 
0 
7 
21151 
169616 

17426 
606 
0 
0 
749 
179 
0 
0 
0 
0 
0 
1 
31 
33 
0 
0 
0 
0 
0 
5 
4 
120 
99 
0 
120 
19373 

302476 
56079 
3764 
276 
1946 
892 
0 
261 
0 
0 
0 
248 
31 
108 
0 
0 
68 
106 
0 
5 
4 
120 
99 
48 
21271 
387802 

EN 

19 

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 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

3477 
72 
536 
0 
0 
363 
0 
0 
0 
0 
0 
121 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1249 
0 
0 
1600 
7418 

13930 
4662 
203 
0 
0 
4063 
0 
0 
0 
0 
0 
692 
0 
0 
20 
0 
0 
0 
0 
0 
0 
18534 
0 
0 
0 
42104 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

4500 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4500 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

14863 
49469 
2450 
0 
0 
914 
0 
0 
0 
0 
0 
34 
0 
0 
0 
0 
0 
35 
0 
0 
0 
0 
0 
0 
0 
67765 

100 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
100 

36870 
54203 
3189 
0 
0 
5340 
0 
0 
0 
0 
0 
847 
0 
0 
20 
0 
0 
35 
0 
0 
0 
19783 
0 
0 
1600 
121887 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

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 

20 

EN 

Footnotes: 

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 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
TOTAL 
6.z. 
Examples: 

21297 
3640 
93 
0 
0 
136 
0 
227 
0 
0 
0 
0 
0 
0 
2 
0 
0 
51 
0 
0 
0 
0 
0 
0 
240 
25686 

3702 
7086 
4962 
150 
0 
1409 
0 
132 
0 
0 
0 
453 
0 
18 
0 
0 
11 
0 
0 
0 
0 
4124 
0 
0 
3476 
25523 

10 
0 
30 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
40 

5 
422 
2 
0 
0 
62 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
270 
761 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

4212 
2961 
1444 
11 
0 
311 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
211 
0 
0 
0 
0 
0 
0 
0 
9150 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

29226 
14109 
6531 
161 
0 
1918 
0 
359 
0 
0 
0 
453 
0 
18 
2 
0 
11 
262 
0 
0 
0 
4124 
0 
0 
3986 
61160 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Norwegian requirement 
6.5 – Poland is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

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 

21 

EN 

Footnotes: 

EN 

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

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 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino-
genicity 

7.8 
Develop-
mental 
toxicity 

7.9 
Muta-
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

320 
24 
0 
0 
0 
5 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
760 
1109 

5089 
405 
5 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5499 

11864 
5618 
116 
0 
0 
234 
0 
249 
0 
0 

0 
187 
0 
0 
2 
0 
11 
99 
0 
0 
0 
3365 
0 
0 
2136 
23881 

0 
6 
0 
11 
0 
351 
0 
0 
0 
0 

0 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
371 

EN 

0 
0 
6410 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6410 

22 

0 
0 
0 
0 
0 
117 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
117 

733 
4390 
0 
0 
0 
54 
0 
107 
0 
0 

0 
80 
0 
0 
0 
0 
0 
145 
0 
0 
0 
0 
0 
0 
1050 
6559 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
493 
0 
0 
0 
34 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
527 

182 
92 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
274 

36 
2710 
0 
0 
0 
4 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2750 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

11002 
371 
0 
150 
0 
1119 
0 
3 
0 
0 

0 
183 
0 
18 
0 
0 
0 
18 
0 
0 
0 
759 
0 
0 
40 
13663 

29226 
14109 
6531 
161 
0 
1918 
0 
359 
0 
0 

0 
453 
0 
18 
2 
0 
11 
262 
0 
0 
0 
4124 
0 
0 
3986 
61160 

EN 

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

8.1 
Products 

Types of tests versus 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 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta-
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

329 

402 

12418 

314 

5942 

0 

0 

0 

0 

0 

0 

760 

20 

90 

82 

0 

0 

36 

160 

0 

91 

2149 

0 

0 

25 

0 

0 

4729 

9198 

36 

21 

0 

0 

0 

0 

0 

0 

468 

0 

0 

0 

0 

0 

0 

0 

78 

33 

6 

0 

0 

0 

0 

0 

0 

5248 

0 

100 

0 

0 

0 

0 

1050 

161 

1109 

5499 

23881 

371 

6410 

117 

6559 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

218 

152 

856 

0 

0 

422 

289 

90 

1468 

0 

0 

0 

0 

0 

20 

0 

0 

32 

0 

0 

0 

0 

0 

0 

0 

4 

0 

0 

0 

0 

0 

0 

2320 

28277 

0 

0 

8 

0 

1140 

4205 

8 

0 

0 

218 

311 

0 

648 

808 

0 

0 

1814 

0 

10469 

24597 

527 

274 

2750 

0 

13663 

61160 

EN 

23 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CYPRUS 

Statistical data submitted 

The statistical data were submitted by Veterinary Services of the Republic of Cyprus. 

Comments of the Cypriot authorities 

None 

EN 

24 

   EN 

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

1.1 
Species 

Origin versus 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 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

1301 

10 

17 

1328 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

1328 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the Council  of  Europe which,  at  the  beginning  of  the  reporting period,  are  Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

25 

EN 

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

2.1 
Species 

Purpose versus 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 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

1139 

108 

81 

1139 

108 

0 

0 

0 

0 

81 

0 

1328 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1328 

EN 

26 

EN 

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

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 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

211 

183 

157 

0 

211 

183 

157 

0 

551 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
551 

EN 

27 

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 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

0 

0 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 - Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Swiss  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep.,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example: a test required by French legislation and carried out in Belgium according to an 

0 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

0 

0 

0 

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  

28 

EN 

Footnotes: 

EN 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LATVIA 

Statistical data submitted 

The statistical data were submitted by the State Food and Veterinary Service. 

Comments of Latvian authorities  

None 

EN 

29 

   EN

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

1.1 
Species 

Origin versus 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 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

6300 
4020 

9 

6300 
4020 
0 
0 

0 
0 
9 
0 

0 
0 
0 
0 

0 

10329   

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the Council  of  Europe which,  at  the  beginning  of  the  reporting period,  are Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

30 

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 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

1200 
1370 

2111 
527 

2989 
2123 

9 

2570 

2647 

5112 

0 

0 

0 

0 

0 

6300 
4020 
0 
0 
0 
0 
0 
9 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
10329 

EN 

31 

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 contami-
nants in the 
general envi-
ronment which 
do not appear in 
other columns 

3.11 
Total 

3.10 
Other toxico-
logical or 
safety 
evaluations 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

EN 

32 

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 

854 
605 

1587 
1002 

4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 

291 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

579 
290 

9 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
Pigs 
4.l. 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

1459 

2589 

291 

878 

0 

3311 
1897 
0 
0 
0 
0 
0 
9 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5217 

EN 

33 

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 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

2989 
2123 

0 

5112 

2989 
2123 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5112 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

0 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

0 

0 

0 

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 

34 

EN 

Footnotes: 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LITHUANIA 

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  Animal  Health  and  Welfare 
Department of the State Food and Veterinary Service of the Republic of Lithuania. 

Comments of Lithuanian authorities 

The  legal  basis  for  the  collection  of  statistics  on  the  number  and  use  of  vertebrate 
animals for experimental and other scientific purposes in Lithuania is provided by: 

The  State  Food  and  Veterinary  Service  Director  Decree  No  B1-639  (Government 
Gazette  2009, No    8-287)  on  the  protection  of  animals  used  for  experimental  and 
other  scientific  purposes,  in  accordance  with  Council  Directive  86/609/EEC  and 
European  Convention  on  the  protection  of  animals  used  for  experimental  and  other 
scientific purposes. 

The total number of animals used in experiments in Lithuania in 2011 was 4,067. 

Rodents  accounted  for  88,64%  of  all  animals  used  –  3,605  animals  (2,131  mice  – 
accounting  for  59,11  %,  1,297  rats  -  accounting  for  35,98  %,  177  guinea  pigs  – 
accounting for 4,91 %). 

Rabbits represent 6,74 % (274 animals). 

Cold-blooded  animals  (amphibians)  represented  3,66  %  of  the  animals  used  –  149 
animals, of which 100 % were used for education and training purposes.  

Pigs accounted for 0,5 % of the animals used  (19  animals),  of which 52,63  % were 
used for research and development of products and devices for human medicine and 
dentistry and for veterinary medicine, 47,37 % for diagnosis of disease purposes.  

Birds accounted for 0,5 % (20 animals), of which 100% were used for research and 
development  of  products  and  devices  for    human  medicine  and  dentistry  and  for 
veterinary medicine.  

No primates were used. 

No animals have been used for cosmetics testing. 

EN 

35 

   EN

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

1.1 
Species 

Origin versus 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 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

2131 
1297 
177 

274 

2131 
1297 
177 
0 

274 
0 
0 
0 

19 

0 
0 
0 
0 

0 
20 

149 

4067

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated 

list of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

36 

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 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

25 

200 
26 
7 

309 
90 

7 

2 

9 
5 
5 

6 

9 

574 
670 
55 

53 

1014 
506 
110 

206 

10 

20 

1352 

1866 

25 

0 

240 

410 

149 

174 

0 

2131 
1297 
177 
0 
0 
274 
0 
0 
0 
0 

0 
19 
0 
0 
0 
0 
0 
0 
0 
0 
0 
20 
0 
149 
0 
4067 

EN 

37 

EN 

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

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 

Products versus species 

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 

3.11 
Total 

3.10 
Other toxico-
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami-
nants in the 
general envi-
ronment which 
do not appear in 
other columns 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
200 
26 
7 

7 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

200 
26 
7 
0 
0 
7 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
240 

0 

0 

0 

0 

0 

0 

240 

0 

0 

EN 

38 

EN 

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

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 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
Pigs 
4.l. 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

300 

400 

0 

0 

300 

43 

443 

0 

700 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
43 
0 
743 

EN 

39 

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 

5.2  
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) 

25 

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 

5.1 
Species 

5.a.  Mice 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

25 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
25 

25 

0 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

0 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

0 

0 

0 

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 

40 

EN 

Footnotes: 

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 

200 
26 
7 

7 

6.a.  Mice 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
TOTAL 
6.z. 
Examples: 

200 
26 
7 
0 
0 
7 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
240 

0 

0 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Norwegian requirement 
6.5 – Poland is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

0 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

Note: 

240 

0 

0 

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 

41 

EN 

Footnotes: 

EN 

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

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 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino-
genicity 

7.8 
Develop-
mental 
toxicity 

7.9 
Muta-
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

200 
26 
7 

7 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

240 

200 
26 
7 
0 
0 
7 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
240 

EN 

42 

EN 

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

8.1 
Products 

Types of tests versus 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 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

EN 

43 

200 

200 

26 

7 

7 

26 

7 

0 

0 

7 

0 

0 

0 

0 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LUXEMBOURG  

Statistical data submitted 

The statistical data were submitted by the 'Ministère de l’Agriculture, de la viticulture 
et  du  développement  rural.  Administration  des  Services  Vétérinaires'  (Ministry  of 
Agriculture,  viticulture  and  rural  development.  Administration  of  Veterinary 
Services). 

Comments of Luxembourg authorities  

None

EN 

44 

   EN

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

1.1 
Species 

Origin versus 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 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

470 
32 

470 
32 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

502   

Note 1:  Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list 

of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

45 

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 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

470 
32 

502 

0 

0 

0 

0 

0 

0 

0 

470 
32 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
502 

EN 

46 

EN 

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

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 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

100 
20 

50 
12 

280 

40 

120 

62 

280 

40 

0 

470 
32 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
502 

EN 

47 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HUNGARY 

Statistical data submitted 

The statistical data were submitted by the Ministry of Rural Development. 

Comments of the Hungarian authorities 

The  total  number  of  animals  used  for  experimental  and  other  scientific  purposes  in  2011  was 
276.179 which represents a 9,4% decrease compared to the same figure of 2008. 

The  use  of  other  rodents,  goats  and  reptiles  fell  to  zero.  The  decrease  was  considerable  in  the 
number of cattle (94,6%), horses and donkeys (77,5%), hamsters (59%), amphibians (38,7%), rats 
(20,7%), and sheep (20%). 

On the other hand the use of fish more than doubled and eighteen times as many quals were used 
than in 2008. 

The  trend  of  monkeys  turned  in  the  past  few  years:  no  new  world  monkey  were  used,  but  the 
number of old world monkeys grew. 

Compared to 2008 no rabbits, but cats were re-used. 

The  amount  of  animals  used  for  production  and  quality  control  of  products  and  devices  for 
veterinary medicine (more than doubled) and for toxicological and other safety evaluations (almost 
doubled) were increased , but a lot less (half) were used to education and training. 

EN 

48 

   EN 

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

1.1 
Species 

Origin versus 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 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

143755 
70873 
9228 
88 
0 
7567 
34 
675 
0 
0 
9 
1278 
0 
160 
5 
0 
0 
7 
0 
0 
235 
36304 
0 
725 
5236 
276179

104761 
56330 
9101 
88 
0 
7233 
25 
370 
0 
0 
0 
79 
0 
0 
0 
0 
0 
7 
0 
0 
235 
0 
0 
0 
2142 

26269 

38678 
13520 
81 
0 
0 
13 
9 
144 
0 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

7891 

316 
1023 
46 
0 
0 
321 
0 
161 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

1577 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 
0 
0 
0 
0 
0 
20 
88 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the Council  of  Europe which,  at  the  beginning  of  the  reporting period,  are Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

49 

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.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

34512 
22398 
436 
88 
0 
2128 
14 
228 
0 
0 

0 
885 
0 
6 
2 
0 
0 
7 
0 
0 
0 
5177 
0 
125 
374 
66380 

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) 

69495 
32540 
781 
0 
0 
772 
20 
89 
0 
0 

8 
101 
0 
37 
0 
0 
0 
0 
0 
0 
0 
1485 
0 
0 
0 
105328 

EN 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

3175 
20 
0 
0 
0 
110 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
100 
3420 

829 
2123 
169 
0 
0 
207 
0 
18 
0 
0 

0 
1 
0 
0 
0 
0 
0 
0 
0 
0 
0 
146 
0 
600 
564 
4657 

1270 
720 
78 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
5 
0 
0 
0 
0 
0 
0 
0 
1726 
0 
0 
0 
3799 

143755 
70873 
9228 
88 
0 
7567 
34 
675 
0 
0 

9 
1278 
0 
160 
5 
0 
0 
7 
0 
0 
235 
36304 
0 
725 
5236 
276179 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

15649 
12961 
5398 
0 
0 
3052 
0 
340 
0 
0 

1 
39 
0 
0 
3 
0 
0 
0 
0 
0 
235 
30 
0 
0 
4198 
41906 

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 

15833 
111 
858 
0 
0 
221 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
17023 

2992 
0 
1508 
0 
0 
1077 
0 
0 
0 
0 

0 
252 
0 
112 
0 
0 
0 
0 
0 
0 
0 
27725 
0 
0 
0 
33666 

50 

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.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

10608 
3909 
3854 
0 
0 
1941 
0 
196 
0 
0 
1 
37 
0 
0 
3 
0 
0 
0 
0 
0 
0 
30 
0 
0 
0 
20579 

560 
958 
20 
0 
0 
144 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
252 
1934 

921 
269 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
342 
1532 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.7 
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 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.8 
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 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

3.11 
Total 

3.10 
Other toxico- 
logical or 
safety 
evaluations 

3.9 
Potential or 
actual contami- 
nents in the 
general envi- 
ronment which 
do not appear in 
other columns 

139 
219 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1720 
2078 

3421 
7606 
1524 
0 
0 
967 
0 
144 
0 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
235 
0 
0 
0 
1884 
15783 

15649 
12961 
5398 
0 
0 
3052 
0 
340 
0 
0 
1 
39 
0 
0 
3 
0 
0 
0 
0 
0 
235 
30 
0 
0 
4198 
41906 

EN 

51 

EN 

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

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 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

993 
3537 
46 
0 
0 
518 
0 
177 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5271 

61386 
33058 
0 
0 
0 
13 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
94457 

6711 
563 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
7274 

15545 
5954 
176 
0 
0 
174 
0 
16 
0 
0 
0 
17 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
100 
0 
21997 

2316 
0 
68 
0 
0 
198 
9 
0 
0 
0 
1 
58 
0 
0 
0 
0 
0 
0 
0 
0 
0 
566 
0 
0 
304 
3520 

86951 
43112 
290 
0 
0 
903 
9 
193 
0 
0 
1 
75 
0 
0 
0 
0 
0 
0 
0 
0 
0 
581 
0 
100 
304 
132519 

EN 

52 

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 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

14094 
111 
215 
0 
0 
13 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
14433 

4471 
0 
2151 
0 
0 
1233 
0 
0 
0 
0 
0 
252 
0 
112 
0 
0 
0 
0 
0 
0 
0 
27355 
0 
0 
0 
35574 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

210 
0 
0 
0 
0 
52 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
370 
0 
0 
0 
632 

50 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
50 

18825 
111 
2366 
0 
0 
1298 
0 
0 
0 
0 
0 
252 
0 
112 
0 
0 
0 
0 
0 
0 
0 
27725 
0 
0 
0 
50689 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 - Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Swiss  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep.,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

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  

53 

EN 

Footnotes: 

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 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
TOTAL 
6.z. 
Examples: 

1155 
466 
0 
0 
0 
13 
0 
16 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1284 
2934 

11809 
5317 
1308 
0 
0 
2154 
0 
99 
0 
0 
1 
20 
0 
0 
3 
0 
0 
0 
0 
0 
0 
30 
0 
0 
1094 
21835 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

483 
89 
0 
0 
0 
0 
0 
0 
0 
0 
0 
17 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
589 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

2112 
6903 
3559 
0 
0 
885 
0 
144 
0 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
235 
0 
0 
0 
1800 
15640 

90 
186 
531 
0 
0 
0 
0 
81 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
20 
908 

15649 
12961 
5398 
0 
0 
3052 
0 
340 
0 
0 
1 
39 
0 
0 
3 
0 
0 
0 
0 
0 
235 
30 
0 
0 
4198 
41906 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Norwegian requirement 
6.5 – Poland is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Swiss  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep.,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

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  

54 

EN 

Footnotes: 

EN 

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

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 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino- 
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta- 
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

7.2.3 
Non lethal 
clinical signs 
methods 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

8746 
3915 
631 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
155 
0 
0 
0 
2327 
15774 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

2189 
3008 
1291 
0 
0 
1866 
0 
148 
0 
0 

1 
37 
0 
0 
3 
0 
0 
0 
0 
0 
0 
30 
0 
0 
0 
8573 

0 
0 
0 
0 
0 
377 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
377 

EN 

2574 
0 
1822 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4396 

55 

0 
0 
0 
0 
0 
328 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
328 

0 
2606 
1582 
0 
0 
0 
0 
176 
0 
0 

0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4366 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
96 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
96 

269 
364 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
633 

0 
2008 
0 
0 
0 
362 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2370 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
712 
712 

1871 
964 
72 
0 
0 
119 
0 
16 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
80 
0 
0 
0 
1159 
4281 

15649 
12889 
5398 
0 
0 
3052 
0 
340 
0 
0 

1 
39 
0 
0 
3 
0 
0 
0 
0 
0 
235 
30 
0 
0 
4198 
41906 

EN 

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

8.1 
Products 

Types of tests versus 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 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta- 
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

6655 

19 

395 

0 

2630 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

9377 

1043 

0 

0 

0 

0 

0 

1220 

4134 

15774 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

388 

97 

95 

772 

0 

0 

0 

0 

0 

97 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

261 

377 

3134 

231 

1736 

4396 

328 

4366 

0 

0 

0 

0 

0 

130 

1400 

8573 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

96 

0 

0 

0 

0 

0 

0 

0 

0 

0 

418 

0 

0 

0 

0 

0 

488 

0 

919 

20579 

124 

0 

90 

1934 

0 

0 

0 

0 

0 

0 

342 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1532 

0 

0 

0 

0 

370 

358 

2078 

0 

215 

1758 

0 

2914 

15783 

96 

633 

2370 

712 

4281 

41906 

EN 

56 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MALTA 

Statistical data submitted 

The  data  were  submitted  by  the  Ministry  for  Resources  and  Rural  Affairs,  Veterinary  and 
Phytosanitary Regulation Department. 

Comments of Malta authorities 

None 

EN 

57 

   EN 

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

1.1 
Species 

Origin versus 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 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
10 
0 
0 
0 
0 
0 
10 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the Council  of  Europe which,  at  the  beginning  of  the  reporting period,  are Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

58 

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 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

10 

10 

0 

0 

0 

0 

0 

0 

0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
10 
0 
0 
0 
0 
0 
10 

EN 

59 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THE NETHERLANDS  

Statistical data submitted 

The statistical data were prepared, quality assured and submitted by the 'Nederlandse Voedsel 
en Waren Autoriteit' (Netherlands Food and Consumer Product Safety Authority). 

Comments of the Dutch authorities  

On 5 February 1997, the revised version of the Experiments on Animals Act (1977) entered 
into force.  

The  provisions  of  the  European  Directive  on  the  approximation  of  laws,  regulations  and 
administrative provisions of the Member States regarding the protection of animals used for 
experimental and other scientific purposes (86/609/EEC) have been implemented.  

In addition, among others the following provisions have been issued: 

-  Animal experiments using LD50/LC50 methods are prohibited. However, for acute dermal 
and  acute  respiratory  toxicity  tests  a  general  exemption  is  granted,  due  to  the  lack  of 
validated alternative methods. 

-  Animal experiments for new or existing cosmetics are prohibited. 
-  Since 2003 animal experiments on great apes are prohibited. 
-  Every animal experiment to be performed has to be recommended by a recognised ethical 
review committee. Such a committee comprises at least seven members, one of whom is 
the chairperson. In addition, such a committee comprises in equal numbers experts in the 
fields  of  animal  experiments,  experts  in  the  field  of  alternative  methods,  experts  in  the 
field  of  animal  welfare  and  protection  and  experts  in  the  field  of  ethical  assessment.  At 
least two of these experts are not involved in the conduct of experiments on animals. The 
chairperson and at least two members are not in the employ of any licence holder applying 
to the committee. The animal welfare officer is involved already at an early stage in the 
review of experiments and acts as a permanent advisor for the ethical review committee. 
At this moment 23 ethical review committees are recognized.  

Licenses to perform animal experiments are issued by the Minister of Public Health, Welfare 
and Sport to a natural or legal person who is a mandated representative of an establishment 
for  animal  use.  So  licensed,  those  people  are  responsible  for  assuring  that  the  legal 
requirements are complied with. The welfare of the experimental animals is supervised by a 
qualified veterinarian or another competent person in charge of the licensee. 

A  Standing  Committee  advises  the  Minister  on  the  administration  of  the  Act  and  other 
related  issues.  The  Committee  consists  of  experts  in  the  field  of  animal  experimentation, 
laboratory animal science and animal welfare. 

The enforcement of the Act has been commissioned to the Netherlands Food and Consumer 
Product Safety Authority.  

The creation of transgenic animals 
In  2011,  for  the  creation  of  transgenic  animals,  12,251  animals  (11,494  mice,  546  rats,  48 
other birds and 163 fish) were used.  

Breeding of animals which had a fenotype with harmful effect 

EN 

60 

   EN 

 
 
In  2011  there  were  11,890  animals  used  for  breeding  which  had  a  fenotype  with  harmful 
effects. Concerning 11,015 genetically altered mice, 172 genetically altered rats and 703 mice 
without a genetical modification 

Collection of data  
72 establishments completed the 2011 registration form.  

These establishments can be categorized as follows: 

a)  Universities and university hospitals 
b)  Public health research institutes 
c)  Agricultural and veterinary research institutes 
d)  Other research institutes 
e)  Industries  and companies  
f)  Schools for vocational training 
g)  Breeders   

15 
  4 
  3 
  4 
38 
  6 
  2 

The killing of an animal without any previous intervention 

In  the  Netherlands,  the  killing  of  an  animal  without  any  previous  intervention  in  the 
framework  of  research  or  testing,  e.g.  for  organ/blood  collection,  is  considered  to  be  an 
experiment. The rationale of this is that the Inspectorate must have the power to supervise the 
killing of laboratory animals.  

This is in contrast to the Council of Europe Convention ETS 123 and Directive 86/609/EEC, 
where the use of an animal for an experimental or other scientific purpose is not considered an 
experiment  if  the  least  painful  method  of  killing  accepted  in  modern  practice    (‘humane’ 
methods’) is used. 

In 2011, 67,196 animals were killed without previous intervention. 

Re-use of the animals (in 2011, 8,077 animals) is included as well in the Dutch statistics 

Total number of animals used 

In 2011, according to the EU Tables, the total number of animals used was 514,617. 

This is 3,2% (16,314) more than the number of animals used in 2010 (498,303). 

The total number of genetically  modified animals  that  was  used  was  93,349.  When  split  up 
into species, the numbers of genetically modified animals used are: 89,704 mice, 419 rats, 200 
rabbits and 3,026 fish. 

Discomfort   

General 

Data has to be registered after an experiment has been performed. This includes data on the 
degree of discomfort; i.e. experienced discomfort. 

As a consequence of the animal experiments performed in 2008: 

• 

• 

36,35% of the animals experienced minor discomfort; 

29,30% of the animals experienced minor/moderate discomfort; 

EN 

61 

   EN 

 
  
 
 
 
• 

• 

• 

• 

21,67% of the animals experienced moderate discomfort; 

8,98% of the animals experienced moderate/severe discomfort; 

3,68% of the animals experienced severe discomfort; and 

0.02% of the animals experienced very severe discomfort. 

EN 

62 

   EN 

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

1.1 
Species 

Origin versus 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 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 

Rats (Rattus norvegicus) 
Guinea-Pigs (Cavia porcellus) 
Hamsters (Mesocricetus ) 
Other Rodents (other Rodentia) 
Rabbits (Oryctolagus cuniculus) 
Cats (Felis catus) 
Dogs (Canis familiaris) 
Ferrets (Mustela putorius furo) 
Other Carnivores (other Carnivora) 
Horses, donkeys and cross breds (Equidae) 
Pigs (Sus) 

1.a.  Mice (Mus musculus) 
1.b. 
1.c. 
1.d. 
1.e. 
1.f. 
1.g. 
1.h. 
1.i. 
1.j. 
1.k. 
1.l. 
1.m.  Goats (Capra) 
1.n. 
1.o. 
1.p. 
1.q. 
1.r. 
1.s. 
1.t. 
1.u. 
1.v. 
1.w. 
1.x. 
1.y. 
1.z. 

Sheep (Ovis) 
Cattle (Bos) 
Prosimians (Prosimia) 
New World Monkeys (Ceboidea) 
Old World Monkeys (Cercopithecoidea) 
Apes (Hominoidea) 
Other Mammals (other Mammalia) 
Quail (Coturnix coturnix) 
Other birds (other Aves) 
Reptiles (Reptilia) 
Amphibians (Amphibia) 
Fish (Pisces) 
TOTAL 

202 725 
57 765 
3 191 
3 476 

1 614 
103 
415 
0 

0 
0 
73 
0 

68 

31 817 
41 029 
2 287 
156 

4 651 
0 
149 
666 

0 
0 
20 
0 

0 

237 784 
98 881 
5 493 
3 632 
979 
6 293 
174 
692 
852 
430 
2 371 
14 686 
284 
2 600 
2 383 
0 
22 
184 
0 
41 
68 
99 354 
133 
1 247 
36 034 
514 617   

3 242 
87 
15 
0 

28 
71 
128 
186 

0 
22 
91 
0 

0 

138 
22 
289 
14 

0 
1 
111 
0 

Note 1:  Column  1.5  concerns  only  those  Member  Countries  of  the Council  of  Europe which,  at  the  beginning  of  the  reporting period,  are Parties  to  the  Convention  ETS  123.  Thus  an 

updated list of those countries has to be used when filling in this column. 

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

Note 3: 

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

EN 

63 

EN 

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

Purpose versus species 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

2.a.  Mice 
Rats 
2.b. 
Guinea-Pigs 
2.c. 
Hamsters 
2.d. 
Other Rodents 
2.e. 
Rabbits 
2.f. 
Cats 
2.g. 
Dogs 
2.h. 
Ferrets 
2.i. 
Other Carnivores 
2.j. 
Horses,  donkeys  and  cross 
2.k. 
breds 
Pigs 

2.l. 
2.m.  Goats 
Sheep 
2.n. 
Cattle 
2.o. 
Prosimians 
2.p. 
New World Monkeys 
2.q. 
Old World Monkeys 
2.r. 
Apes 
2.s. 
Other Mammals 
2.t. 
Quail 
2.u. 
Other birds 
2.v. 
Reptiles 
2.w. 
Amphibians 
2.x. 
Fish 
2.y. 
TOTAL 
2.z. 

166 354 
28 621 
505 
432 
699 
498 
49 
164 
282 
121 
24 

8 925 
139 
274 
586 

5 
39 

39 
68 
65 293 
133 
127 
31 967 
305 344 

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 

4 930 
28 937 
829 

366 

58 

101 

6 

1 900 
237 

14 372 
5 802 
3 465 
2 916 

1 973 
38 
183 

309 
2 030 

1 671 
1 
26 
307 

2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 

5 229 
27 619 
116 

2 872 

152 

43 

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) 

30 471 
4 886 
524 
245 
280 
402 

101 
497 

194 

3 387 
137 
273 
883 

17 
145 

2 

9 380 

28 

7 048 
3 016 
54 
39 

154 
87 
92 
15 

22 

654 
7 
127 
370 

237 784 
98 881 
5 493 
3 632 
979 
6 293 
174 
692 
852 
430 

2 371 
14 686 
284 
2 600 
2 383 
0 
22 
184 
0 
41 
68 
99 354 
133 
1 247 
36 034 
514 617 

11 532 

22 

21 180 

281 

1 046 

53 976 

37 386 

54 273 

1 120 
3 580 
40 731 

9 689 

487 
13 218 

0 

EN 

64 

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 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 

3.9 
Potential or 
actual contami-
nants in the 
general envi-
ronment which 
do not appear in 
other columns 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
144 
200 

3.11 
Total 

3.10 
Other toxico-
logical or 
safety 
evaluations 

21 

80 
6 150 

1 985 
14 093 
49 

1 089 

28 

3 020 
7 127 
67 

1 783 

152 

43 

3.a.  Mice 
Rats 
3.b. 
Guinea-Pigs 
3.c. 
Hamsters 
3.d. 
Other Rodents 
3.e. 
Rabbits 
3.f. 
Cats 
3.g. 
Dogs 
3.h. 
Ferrets 
3.i. 
Other Carnivores 
3.j. 
Horses, donkeys and cross breds 
3.k. 
3.l. 
Pigs 
3.m.  Goats 
Sheep 
3.n. 
Cattle 
3.o. 
Prosimians 
3.p. 
New World Monkeys 
3.q. 
Old World Monkeys 
3.r. 
Apes 
3.s. 
Other Mammals 
3.t. 
Quail 
3.u. 
Other birds 
3.v. 
Reptiles 
3.w. 
Amphibians 
3.x. 
Fish 
3.y. 
TOTAL 
3.z. 

12 192 

6 230 

17 216 

28 

0 

344 

0 

1 120 
3 372 
4 492 

208 
229 

5 229 
27 619 
116 
0 
0 
2 872 
0 
152 
0 
0 
0 
43 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 120 
3 580 
40 731 

EN 

65 

EN 

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

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 

Main categories versus species 

4.a.  Mice 
Rats 
4.b. 
Guinea-Pigs 
4.c. 
Hamsters 
4.d. 
Other Rodents 
4.e. 
Rabbits 
4.f. 
Cats 
4.g. 
Dogs 
4.h. 
Ferrets 
4.i. 
Other Carnivores 
4.j. 
Horses, donkeys and cross breds 
4.k. 
4.l. 
Pigs 
4.m.  Goats 
Sheep 
4.n. 
Cattle 
4.o. 
Prosimians 
4.p. 
New World Monkeys 
4.q. 
Old World Monkeys 
4.r. 
Apes 
4.s. 
Other Mammals 
4.t. 
Quail 
4.u. 
Other birds 
4.v. 
Reptiles 
4.w. 
Amphibians 
4.x. 
Fish 
4.y. 
TOTAL 
4.z. 

18 898 
3 625 
0 
0 
0 
230 
0 
68 
0 
0 
0 
421 
33 
10 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
23 285 

17 365 
11 731 
55 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 
0 
4 162 
33 314 

52 091 
1 350 
0 
0 
0 
164 
0 
0 
0 
0 
0 
32 
0 
0 
0 
0 
0 
0 
0 
0 
0 
100 
0 
0 
119 
53 856 

71 800 
9 474 
391 
168 
288 
411 
0 
43 
779 
0 
10 
188 
147 
271 
19 
0 
17 
169 
0 
10 
0 
373 
0 
0 
936 
85 494 

11 253 
139 
430 
245 
0 
54 
42 
154 
0 
0 
184 
3 737 
34 
266 
969 
0 
0 
0 
0 
0 
0 
26 516 
0 
0 
184 
44 207 

171 407 
26 319 
876 
413 
288 
859 
42 
265 
779 
0 
194 
4 378 
214 
547 
988 
0 
18 
169 
0 
10 
0 
26 989 
0 
0 
5 401 
240 156 

EN 

66 

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 
Rats 
5.b. 
Guinea-Pigs 
5.c. 
Hamsters 
5.d. 
Other Rodents 
5.e. 
Rabbits 
5.f. 
Cats 
5.g. 
Dogs 
5.h. 
Ferrets 
5.i. 
Other Carnivores 
5.j. 
Horses, donkeys and cross breds 
5.k. 
5.l. 
Pigs 
5.m.  Goats 
Sheep 
5.n. 
Cattle 
5.o. 
Prosimians 
5.p. 
New World Monkeys 
5.q. 
Old World Monkeys 
5.r. 
Apes 
5.s. 
Other Mammals 
5.t. 
Quail 
5.u. 
Other birds 
5.v. 
Reptiles 
5.w. 
Amphibians 
5.x. 
Fish 
5.y. 
5.z. 
TOTAL 
Examples: 

1 320 
4 354 
190 

1 

25 

25 

5 865 

1 864 
684 
250 

70 

4 

11 596 
29 053 
2 034 
2 916 

1 892 
38 
168 

82 
1 290 

2 
104 

4 522 
648 
1 820 

376 

15 
58 
309 
2 049 
387 
1 
1 924 
411 

18 381 

2 821 

19 302 
34 739 
4 294 
2 916 
0 
2 339 
38 
183 
58 
309 
2 131 
1 677 
1 
1 926 
544 
0 
0 
0 
0 
0 
0 
21 202 
0 
0 
0 
91 659 

5.2 – France is testing due to a UK (or FR) specific requirement 
5.3 - UK is testing according to EC legislation 
5.4 – Spain is testing due to a Norwegian requirement 
5.5 – Poland is testing due to a US specific requirement 
5.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

15 341 
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 
a test required by French legislation and carried out in Belgium according to an 
ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 5.2 in the tables submitted by Belgium. 

Example: 

67 556 

Note: 

2 872 

0 

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 

67 

EN 

Footnotes: 

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 
Rats 
6.b. 
Guinea-Pigs 
6.c. 
Hamsters 
6.d. 
Other Rodents 
6.e. 
Rabbits 
6.f. 
Cats 
6.g. 
Dogs 
6.h. 
Ferrets 
6.i. 
Other Carnivores 
6.j. 
Horses, donkeys and cross breds 
6.k. 
6.l. 
Pigs 
6.m.  Goats 
Sheep 
6.n. 
Cattle 
6.o. 
Prosimians 
6.p. 
New World Monkeys 
6.q. 
Old World Monkeys 
6.r. 
Apes 
6.s. 
Other Mammals 
6.t. 
Quail 
6.u. 
Other birds 
6.v. 
Reptiles 
6.w. 
Amphibians 
6.x. 
Fish 
6.y. 
TOTAL 
6.z. 
Examples: 

5 
80 

3 598 
27 346 
114 

2 863 

152 

1 626 
193 
2 

9 

33 

10 

5 229 
27 619 
116 
0 
0 
2 872 
0 
152 
0 
0 
0 
43 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 120 
3 580 
40 731 

1 120 
3 072 
38 298 

0 

0 

508 
2 348 
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and 
not to the body which has issued the actual test method, guideline or protocol. 

85 

0 

6.2 – France is testing due to a UK (or FR) specific requirement 
6.3 - UK is testing according to EC legislation 
6.4 – Spain is testing due to a Norwegian requirement 
6.5 – Poland is testing due to a US specific requirement 
6.6  –  Germany  is  testing  due  to  a  Czech  requirement  (also  an  EC 
requirement) 
1)  EC  Member  States:  Austria,  Belgium,  Bulgaria,  Cyprus,  Czech  Rep,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania, 

ISO protocol must be coded as a national (FR) legislative requirement and be 
entered into column 6.2 in the tables submitted by Belgium. 

Example:  a test required by French legislation and carried out in Belgium according to an 

Note: 

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 

68 

EN 

Footnotes: 

EN 

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

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 
Sub- 
chronic and 
chronic 
toxicity 

7.7 
Carcino-
genicity 

7.8 
Develop- 
mental 
toxicity 

7.9 
Muta-
genicit
y 

7.10 
Repro-
ductive 
toxicity 

Types of tests versus species 

7.12 
Other 

7.13 
Total 

7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

7.a.  Mice 
Rats 
7.b. 
Guinea-Pigs 
7.c. 
Hamsters 
7.d. 
Other Rodents 
7.e. 
Rabbits 
7.f. 
Cats 
7.g. 
Dogs 
7.h. 
Ferrets 
7.i. 
Other Carnivores 
7.j. 
Horses,  donkeys  and  cross 
7.k. 
breds 
Pigs 

7.l. 
7.m.  Goats 
Sheep 
7.n. 
Cattle 
7.o. 
Prosimians 
7.p. 
New World Monkeys 
7.q. 
Old World Monkeys 
7.r. 
Apes 
7.s. 
Other Mammals 
7.t. 
Quail 
7.u. 
Other birds 
7.v. 
Reptiles 
7.w. 
Amphibians 
7.x. 
Fish 
7.y. 
TOTAL 
7.z. 

7.2.1. 
LD50, 
LC50 

7.2.2 
Other lethal 
methods 

1 525 
617 

7.2.3 
Non lethal 
clinical signs 
methods 

210 
5 173 
63 

179 

2 577 

49 

968 

610 

10 211 

877 
83 

9 479 

109 

162 

136 

99 

29 

170 

40 

1 177 

40 
299 
4 

1 118 

13 

14 

570 
570 

288 
2 430 

1 120 
605 
7 408 

341 

2 626 

136 

2 117 
3 295 

610 

10 211 

960 

10 656 

0 

1 488 

EN 

69 

5 229 
27 619 
116 
0 
0 
2 872 
0 
152 
0 
0 

0 
43 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 120 
3 580 
40 731 

EN 

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

8.1 
Products 

Types of tests versus 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 

8.7 
Carcino 
genicity 

8.8 
Develop- 
mental 
toxicity 

8.9 
Muta-
genicit
y 

8.10 
Repro-
ductive 
toxicity 

8.6 
Sub- 
chronic 
and 
chronic 
toxicity 

8.12 
Other 

8.13 
Total 

8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

Products/substances  or  devices 
for 
human  medicine  and  dentistry  and  for 
veterinary medicine 
Products/substances used or intended to 
be used mainly in agriculture 
Products/substances used or intended to 
be used mainly in industry 
Products/substances used or intended to 
be used mainly in the household 
Products/substances used or intended to 
be  used  mainly  as  cosmetics  or 
toiletries 
Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 
Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 
Potential  or  actual  contaminants  in  the 
general  environment  which  do  not 
appear in other columns 
toxicological 

safety 

or 

8.i.  Other 

evaluations 
TOTAL 

8.j. 

1 657 

2 789 

100 

1 255 

48 

610 

783 

103 

3 447 

1 400 

12 192 

16 

455 

200 

610 

4 913 

36 

6 230 

465 

2 383 

241 

1 347 

88 

200 

9 428 

716 

2 296 

52  17 216 

4 

24 

32 

24 

168 

120 

570 

288 

1 725 

1 909 

208 

21 

28 

0 

344 

0 

4 492 

229 

570 

2 430 

7 408 

341 

2 626 

136 

3 295 

610 

10 211 

960  10 656 

0 

1 488  40 731 

EN 

70 

EN