Commission staff working document - Annex to the: Report from the Commission to the Council and the European Parliament - Fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union  - Part III {COM (2007) 675 final}
Date: 2007-11-05
Institutions: European Commission
Subjects: EU statistics, animal experimentation, animal welfare, impact study, report, scientific research

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.11.2007 
SEC(2007) 1455 

PART III 

COMMISSION STAFF WORKING DOCUMENT 

Annex to the:  

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT  

Fifth 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 (2007) 675 final}

EN 

   EN 

 
 
 
 
 
 
 
Important notice 

This Report is a document of the Commission services and cannot be considered binding to 
this institution in any way.

EN 

2 

   EN 

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

EN 

3 

   EN 

 
TABLE OF CONTENTS 

ITALY ........................................................................................................................................5 

LATVIA ...................................................................................................................................14 

LITHUANIA ............................................................................................................................25 

LUXEMBOURG ......................................................................................................................36 

MALTA ....................................................................................................................................40 

THE NETHERLANDS ............................................................................................................41 

POLAND ..................................................................................................................................55 

PORTUGAL .............................................................................................................................65 

FINLAND.................................................................................................................................80 

SLOVENIA ..............................................................................................................................89 

SLOVAKIA............................................................................................................................100 

SWEDEN................................................................................................................................114 

UNITED KINGDOM .............................................................................................................126 

EN 

4 

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ITALY  

Statistical data submitted 

The statistical data have been submitted by the Ministry of Health – Department for public veterinary 
health food and animal safety, Directorate-General for animal health and veterinary medicines, Office X 

Comments of Italian authorities  

The  collected  data  are  entered  in  the  “harmonised  EU  statistical  tables”  agreed  by  the  competent 
national authorities of the EU in 1997. 

They generally confirm the downward trend in the total number of animals used in experiments, which 
has remained below the one million mark since 1999. 

93.61% of the animals used were rodents and rabbits. 

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

44.08% 

of the animals were used in basic biological studies. 

27.42% 

of  the  animals  were  used  in  the  research  and  development  of  products  and 

devices for human medicine, dentistry and veterinary medicine. 

15.38% 

of  the  animals  were  used  in  the  production  and  quality  control  of  products  and 

devices for human medicine, dentistry and veterinary medicine.  

8.9% 

of the animals were used in toxicological studies. 

4.22%  

of the animals were used for diagnosis of disease, education and other purposes. 

98.67% 
study animal diseases. 

of  the  animals  were  used  to  study  human  diseases,  while  1.33%  were  used  to 

Article 24  of  Directive  86/609/EEC  has  allowed  tighter  rules  to  be  introduced  into  Italian  law, 
particularly regarding the use of non-human primates, cats and dogs, as may be seen from Article 3(2) 
of Legislative Decree 116/92, which states that “with regard to non-human primates, cats and dogs, 
the authorisation stipulated by Article 8(1)(b) is also required.” 

Special attention was also paid to the use of horses in experiments. 

All in all, this means that horses, non-human primates, cats and dogs together account for 0.17% of all 
animals used. 

Cats are used in experiments in Italy only in investigations of diseases affecting cats themselves. Since 
2003 no animals have been used to test finished cosmetic products. 

Signed:Prof. Sergio Papalia 

Director, Office  

EN 

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 

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 

516400 
276681 
6879 
1473 

9842 
0 
601 
0 

0 
12 
7 
0 

0 

6073 
2758 
4613 
0 

74 
30 
0 
0 

0 
5 
343 
0 

0 

97 
4 
15 
0 
0 
0 
0 
93 
0 

0 
0 
3 
0 

0 

12044 
331 
26 
64 
0 
0 
0 
370 
0 

0 
0 
42 
0 
0 
0 

351 
0 
68 
0 

0 
87 
85 
0 
0 
0 

534614 
279774 
11533 
1537 
2303 
9916 
30 
1064 
0 
0 
63 
2579 
20 
584 
1174 
0 
17 
395 
0 
68 
0 
31697 
378 
4636 
14584 
896966 

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 

6 

EN 

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

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. 

292138 
79546 
1778 
1092 
400 
1766 
0 
12 
0 
0 
34 

758 
13 
187 
1024 
0 
9 
20 
0 
58 
0 
6915 
348 
4495 
4820 
395413 

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) 

146808 
83690 
4040 
76 
1043 
1228 
30 
59 
0 
0 
3 

405 
4 
257 
62 
0 
8 
11 
0 
0 
0 
2519 
0 
30 
5674 
245947 

EN 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

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) 

34518 
30818 
1444 
57 
0 
1626 
0 
993 
0 
0 
0 

333 
0 
14 
0 
0 
0 
327 
0 
0 
0 
6102 
0 
42 
3520 
79794 

24245 
1115 
53 
312 
860 
38 
0 
0 
0 
0 
0 

0 
1 
0 
10 
0 
0 
0 
0 
0 
0 
3 
0 
69 
0 
26706 

403 
317 
15 
0 
0 
0 
0 
0 
0 
0 
0 

249 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
984 

5197 
2125 
12 
0 
0 
208 
0 
0 
0 
0 
2 

745 
2 
0 
4 
0 
0 
0 
0 
0 
0 
1522 
30 
0 
260 
10107 

534614 
279774 
11533 
1537 
2303 
9916 
30 
1064 
0 
0 
63 

2579 
20 
584 
1174 
0 
17 
395 
0 
68 
0 
31697 
378 
4636 
14584 
896966 

26561 
81993 
3740 
0 
0 
4195 
0 
0 
0 
0 
24 

18 
0 
51 
1 
0 
0 
37 
0 
0 
0 
15 
0 
0 
0 
116635 

4744 
170 
451 
0 
0 
855 
0 
0 
0 
0 
0 

71 
0 
75 
73 
0 
0 
0 
0 
10 
0 
14621 
0 
0 
310 
21380 

7 

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. 

12523 
20550 
959 
57 
0 
1479 
0 
929 
0 
0 
0 
313 
0 
12 
0 
0 
0 
327 
0 
0 
0 
6082 
0 
0 
255 
43486 

69 
288 
70 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
427 

290 
2424 
397 
0 
0 
129 
0 
64 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3304 

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 

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 

8 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
390 
766 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1156 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
182 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
182 

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 

2782 
4830 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3265 
10877 

18282 
1960 
18 
0 
0 
18 
0 
0 
0 
0 
0 
20 
0 
2 
0 
0 
0 
0 
0 
0 
0 
20 
0 
42 
0 
20362 

34518 
30818 
1444 
57 
0 
1626 
0 
993 
0 
0 
0 
333 
0 
14 
0 
0 
0 
327 
0 
0 
0 
6102 
0 
42 
3520 
79794 

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. 

13061 
7290 
632 
100 
0 
378 
0 
6 
0 
0 
0 
165 
0 
11 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
21643 

61492 
49905 
966 
659 
986 
195 
0 
141 
0 
0 
0 
2 
0 
0 
0 
0 
12 
3 
0 
0 
0 
0 
0 
131 
0 
114492 

113322 
9863 
0 
144 
0 
19 
0 
268 
0 
0 
0 
0 
0 
40 
0 
0 
0 
125 
0 
0 
0 
0 
0 
0 
221 
124002 

132766 
37583 
2891 
12 
196 
1030 
0 
49 
0 
0 
0 
103 
0 
18 
7 
0 
0 
6 
0 
0 
0 
22 
0 
451 
0 
175134 

4449 
196 
189 
6 
727 
120 
30 
6 
0 
0 
0 
25 
0 
32 
0 
0 
0 
0 
0 
0 
0 
70 
0 
0 
0 
5850 

325090 
104837 
4678 
921 
1909 
1742 
30 
470 
0 
0 
0 
295 
0 
101 
7 
0 
12 
134 
0 
0 
0 
92 
0 
582 
221 
441121 

EN 

9 

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 

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 

Regulatory requirements versus 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: 

4176 
425 
1326 
0 
0 
1112 
0 
0 
0 
0 
24 
50 
0 
119 
57 
0 
0 
0 
0 
10 
0 
1607 
0 
0 
0 
8906 

7816 
1789 
29 
0 
0 
3297 
0 
0 
0 
0 
0 
39 
0 
7 
17 
0 
0 
0 
0 
0 
0 
13029 
0 
0 
0 
26023 

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 

3868 
1712 
206 
0 
0 
181 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
310 
6277 
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. 

15405 
78237 
2630 
0 
0 
460 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
37 
0 
0 
0 
0 
0 
0 
0 
96769 

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

31305 
82163 
4191 
0 
0 
5050 
0 
0 
0 
0 
24 
89 
0 
126 
74 
0 
0 
37 
0 
10 
0 
14636 
0 
0 
310 
138015 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  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: 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

10 

EN 

Footnotes: 

EN 

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

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 

Regulatory requirements versus species 

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. 
6.z. 
TOTAL 
Examples: 

23592 
8821 
199 
0 
0 
110 
0 
137 
0 
0 
0 
20 
0 
2 
0 
0 
0 
0 
0 
0 
0 
4840 
0 
42 
3450 
41213 

6728 
8374 
491 
48 
0 
555 
0 
272 
0 
0 
0 
313 
0 
12 
0 
0 
0 
0 
0 
0 
0 
1262 
0 
0 
0 
18055 

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 

549 
323 
0 
0 
0 
87 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
70 
1029 
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. 

3259 
12359 
754 
9 
0 
874 
0 
584 
0 
0 
0 
0 
0 
0 
0 
0 
0 
327 
0 
0 
0 
0 
0 
0 
0 
18166 

390 
941 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1331 

34518 
30818 
1444 
57 
0 
1626 
0 
993 
0 
0 
0 
333 
0 
14 
0 
0 
0 
327 
0 
0 
0 
6102 
0 
42 
3520 
79794 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

11 

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. 

1201 
667 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2035 
3903 

11332 
960 
0 
0 
0 
0 
0 
4 
0 
0 
0 

0 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 
0 
12297 

6873 
8144 
37 
48 
0 
400 
0 
285 
0 
0 
0 

134 
0 
2 
0 
0 
0 
93 
0 
0 
0 
4840 
0 
0 
170 
21026 

234 
0 
97 
0 
0 
147 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1000 
0 
0 
0 
1478 

EN 

71 
0 
1222 
0 
0 
5 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1298 

12 

0 
0 
0 
0 
0 
38 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
38 

1298 
7813 
84 
0 
0 
64 
0 
657 
0 
0 
0 

92 
0 
0 
0 
0 
0 
158 
0 
0 
0 
0 
0 
0 
1100 
11266 

3596 
4807 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8403 

155 
1619 
0 
0 
0 
514 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
42 
0 
2330 

589 
420 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1009 

389 
1352 
0 
0 
0 
264 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2005 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
215 
215 

8780 
5036 
4 
9 
0 
194 
0 
47 
0 
0 
0 

107 
0 
12 
0 
0 
0 
75 
0 
0 
0 
262 
0 
0 
0 
14526 

34518 
30818 
1444 
57 
0 
1626 
0 
993 
0 
0 
0 

333 
0 
14 
0 
0 
0 
327 
0 
0 
0 
6102 
0 
42 
3520 
79794 

EN 

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

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

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.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 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

1317 

1673 

16992 

1444 

759 

29 

9240 

1433 

1519 

712 

1688 

185 

6495 

43486 

0 

0 

0 

0 

0 

0 

0 

58 

0 

0 

0 

40 

1053 

0 

0 

1006 

182 

0 

2035 

400 

128 

551 

9984 

1807 

0 

34 

0 

0 

0 

0 

0 

0 

70 

468 

0 

0 

0 

0 

0 

1 

0 

9 

0 

0 

0 

0 

0 

0 

0 

466 

0 

0 

150 

0 

0 

0 

0 

0 

0 

0 

1100 

6970 

0 

0 

317 

769 

297 

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 

427 

150 

3304 

0 

0 

0 

0 

0 

1156 

0 

182 

30 

214 

10877 

0 

7667 

20362 

310 

0 

42 

evaluations 
TOTAL 

8.j. 

3903 

12297 

21026 

1478 

1298 

38 

11266 

8403 

2330 

1009 

2005 

215 

14526 

79794 

EN 

13 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LATVIA 

Statistical data submitted 

The statistical data have been submitted by the Ministry of Agriculture – State Food 
and veterinary service 

Comments of Latvian authorities  

None 

EN 

14 

   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 

10480 
2376 
297 

166 

10480 
2376 
297 
0 

166 
0 
0 
0 

0 
0 
0 
0 

0 

13319 

13319 

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 

15 

EN 

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

Purpose versus species 

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

90 

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

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 

2.3 
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) 

3068 
1105 

2800 
613 

2352 
265 
57 

121 

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. 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

766 
177 

1494 
126 
240 

45 

10480 
2376 
297 
0 
0 
166 
0 
0 
0 
0 
0 

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

EN 

16 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.z. 

TOTAL 

2795 

4173 

3413 

0 

90 

1905 

943 

0 

13319 

EN 

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 

3.7 
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. 

90 

0 

0 

0 

0 

0 

0 

0 

0 

90 

0 
90 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
90 

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. 
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. 

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 

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 

2800 
613 

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. 
Pigs 
5.l. 
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: 

Footnotes: 

EN 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

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: 

3413 

0 

0 

20 

EN 

2800 
613 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3413 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

21 

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. 
6.z. 
TOTAL 
Examples: 

90 

0 
90 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
90 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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 

90 
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: 

0 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

22 

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. 

90 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

90 

0 

0 

0 
90 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
90 

EN 

23 

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 

8.2.1. 
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. 

for 
Products/substances  or  devices 
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 

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 

90 

90 

0 

0 

0 

0 

0 

0 

0 

0 

evaluations 
TOTAL 

8.j. 

EN 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

90 

0 

0 

90 

24 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LITHUANIA 

Statistical data submitted 

The statistical data  have  been  submitted by the State Food and Veterinary service – 
Animal welfare department - Siesiku 19 LT-2010 Vilnius 

Comments of Lithuanian authorities  

None 

EN 

25 

   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 

5116 
493 

158 

5116 
493 
0 
0 

158 
0 
0 
0 

0 
0 
0 
0 

0 

5767 

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 

26 

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 

2.4 
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 

2.3 
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) 

1773 
323 

96 

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. 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

2583 

430 
50 

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

330 
120 

62 

5116 
493 
0 
0 
0 
158 
0 
0 
0 
0 
0 

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

EN 

27 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.z. 

TOTAL 

2192 

0 

0 

0 

512 

2583 

480 

0 

5767 

EN 

28 

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. 

330 
120 

62 

62 

450 

0 

0 

0 

0 

0 

0 

0 

330 
120 
0 
0 
0 
62 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
512 

EN 

29 

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. 

2583 

0 

0 

0 

2583 

0 

2583 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2583 

EN 

30 

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. 
Pigs 
5.l. 
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: 

Footnotes: 

EN 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

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 

31 

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 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

32 

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. 
6.z. 
TOTAL 
Examples: 

330 
120 

62 

0 

512 

330 
120 
0 
0 
0 
62 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
512 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

0 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

33 

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 

7.2.3 
Non lethal 
clinical signs 
methods 

100 
60 

230 
60 

62 

0 

0 

160 

0 

0 

0 

0 

0 

0 

0 

0 

0 

352 

EN 

34 

330 
120 
0 
0 
0 
62 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
512 

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.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

for 
Products/substances  or  devices 
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 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

160 

62 

62 

290 

450 

0 

0 

0 

0 

0 

0 

0 

evaluations 
TOTAL 

8.j. 

EN 

0 

0 

160 

0 

0 

0 

0 

0 

0 

0 

0 

0 

352 

512 

35 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LUXEMBOURG  

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  “Ministère  de  l’Agriculture,  de  la 
viticulture  et  du  developpement  rural.  Administration  des  Services  Vétérinaires” 
(Ministry  of  Agriculture,  viticulture  and  rural  development.  Administration  of 
Veterinary Services) 

Comments of Luxembourg authorities  

Comments on statistical data on the use of laboratory animals in the Grand Duchy of 
Luxembourg in 2005 

To DG Environment D.1. 

-  2  experimentation  projects  were  registered  in  Luxembourg  in  2005  compared  to  1 
project in 2004. 

- In comparison with 2004, a 62% decrease in the number of laboratory animals used 
has been recorded (280 more mice, but 500 fewer chicks and 1 800 fewer cotton rats). 

-  Responsibility  for  monitoring  animal  welfare lies with a veterinary inspector, who 
carries out at least 2 inspections per year per requested experimentation project. 

- Detection infrastructure and the handling of laboratory animals comply with animal 
welfare requirements. 

- The experiments are intended for: 

a) an immunological study of the protective efficiency and the antigenicity of antigens 
to improve vaccination strategies and diagnostic procedures for specific diseases; 

b) projects relating to immunology and immunodeficiency. 

Director of the Veterinary 

Services Administration 

Dr Arthur Besch 

Remark: 
Please note that only relevant EU tables containing data are included in this report. No 
uses of animals were reported in Tables 3-8. 

EN 

36 

   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 

3280 
720 
100 

20 

3280 
720 
100 
0 

20 
0 
0 
0 

0 
0 
0 
0 

0 

4120 

4120 

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 

37 

EN 

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

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

280 
320 

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. 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

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) 

2.3 
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) 

3000 
400 
100 

20 

3280 
720 
100 
0 
0 
20 
0 
0 
0 
0 
0 

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

EN 

38 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.z. 

TOTAL 

600 

3520 

0 

0 

0 

0 

0 

0 

4120 

EN 

39 

EN 

 
  
MALTA 

No animals were used in Malta in 2005 for experimental or other scientific purposes. 

EN 

40 

   EN 

 
THE NETHERLANDS  

Statistical data submitted 

The statistical data have been submitted by the “Keuringsdienst van Waren, Ministerie voor 
Volksgezondheid,  Welzijn  en  Sport”  (Inspectorate  for  Goods,  Ministry  for  Public  Health, 
Welfare and Sports 

Comments of the Dutch authorities  

National vs EU statistics 

Since the first national report was published in 1978 the total number of animal experiments 
has  never  been  as  low  as  in  2005.  After  a  faster  decline  the  first  10-15  years  the  decrease 
slowed  down  the  last  10  years.  However  the  overall  tendency  still  seems  to  be  decreasing 
though in a slower pace. 

The  national  statistics  are  published  annually  including  the  eight  tables  constructed  in 
accordance with the EU system. The latest reports can be found at www.vwa.nl. The Dutch 
national statistics differ slightly form the Dutch EU-contribution. The numbers in the national 
statistics are higher due to the following: 

1. 
In addition to the EU statistics, killing animals solely for harvesting tissues or organs 
is considered to be an experiment and contributes to the statistics. In 2005 a total number of 
55.144  animals  (i.e.  7%  of  the  total  number  of  animals  used)  were  killed  for  this  purpose, 
without  any  procedures  or  techniques  connected  with  the  experiment  performed  on  them 
before their death. 

2. 
Furthermore  the  Dutch  statistics  are  based  on  the  number  of  experiments  performed 
and not so much on the number of animals involved. Therefore re-use is included as well. It 
clearly influences the statistics, hence each and every time the animal was used will contribute 
to  the  total  number  of  experiments.  In  2005  28.717  animal  experiments  were  conducted  on 
animals that had already been used. These animals were not included in the EU statistics. 

The national statistics include 19 tables relating species to different topics. Like e.g. origin of 
the  animal,  type  of  experiment,  severity  score,  mandatory  testing,  anaesthesia,  pain 
alleviation, etc. Furthermore 14 tables on type of experiment versus species and their origin, 
safety testing and special techniques, etc are published. Special tables are made per university 
(hospital and academia alike) 15 in total and 2 tables on research performed for the ministry 
of Defence. 

Severity scoring 

All animal experiments have to go through a procedure of ethical reviewing prior to the start 
of  the  experiment.  Part  of  the  ethical  reviewing  is  assessing  by  the  responsible  researcher, 
proposed expected severity score. During the experiment the animals are closely watched also 
to  assess  the  actually  experienced  discomfort,  harm,  distress,  etc.  The  experienced  severity 
score is the one that is registered. The Dutch law recognises 6 severity bands:  

- minor (35.5% of the experiments in 2005) 

EN 

41 

   EN 

 
- minor/moderate (29.2% of the experiments in 2005) 

- moderate (22.0% of the experiments in 2005) 

- moderate/severe (8.8% of the experiments in 2005) 

- severe (4.5% of the experiments in 2005) 

- very severe (0.1% of the experiments in 2005) 

Primates 

In 2005 327 primates were used (50 new world primates and 277 old world primates) for the 
first time, which is 0.62%. A further 5 new world primates and 372 old world primates were 
re-used,  taking  the  total  number  of  animal  experiments  conducted  on  primates  op  to  704 
(0.11% of the total number of animal experiments). 

Since  2003  it  has  been  prohibited  to  perform  animal  experiments  on  great  apes  (behaviour-
studies consisting solely of observing the animals in their normal surroundings and which do 
not  include  any  discomfort,  harm,  distress,  etc.  is  not  considered  to  be  an  experiment. 
Therefore  these  studies  are  exempted  from  the  prohibition).  In  2004  the  last  6  experiments 
were conducted on chimpanzees, hence in 2005 no experiments on great apes were performed 
nor will there be any in the foreseeable future. 

Inspectorate and inspections 

The Food and Consumer Product Safety Authority (VWA) is responsible for enforcement of 
the  legislation  concerning  laboratory  animal  welfare.  The  VWA  conducted  a  total  of  554 
inspections  in  2005  of  which  approximately  40%  was  unannounced  beforehand.  These 
inspections clearly showed that the regulations with direct regard to the welfare of the animals 
were in general well abided by.  

In several cases infringements were detected. Depending on the severity of the infringement 
appropriate  action  was  taken.  In  six  cases  the  licence-holder  received  a  written  warning 
including  a  deadline  for  solving  the  problem.  These  licence-holders  were  told  to  solve  the 
indicated infringement before a certain date. In every case the problems were solved when the 
inspector  re-visited  the  licence-holder  after  the  notified  deadline.  These  infringements 
consisted of: 

- housing of animals; 

- entering remarks in a so-called welfare diary (which has to be present at the animal room to 
be used for recording all relevant welfare remarks); 

- handling of and caring for the animals by not yet licensed personnel; 

-  conducting  experiments  on  animals  not  bred/delivered  by  a  licensed  breeder  without  an 
exoneration by the VWA 

- Conducting an experiment not according to the project plan, which had received a positive 
advice of the ethical review committee. 

EN 

42 

   EN 

 
Comparing 2005 with 2004 

In 2005 fewer experiments were conducted than in 2004. Nearly half of the drop in number of 
animal  experiments  was  due  to  a  lower  number  of  chicken  experiments.  This  still  was  the 
result  of  the  aftermath  of  the  Avian  Influenza  outbreak  in  2003.  Many  projects  were 
postponed  in  2003  due  to  the  restrictions  on  transport  of  animals  and  eggs,  hence  a  low 
number of chickens appeared in the 2003 statistics. In 2004 making up leeway led to a steep 
increase  in  use  of  chickens.  In  2005  the  situation  was  back  to  normal,  thus  the  number 
dropped to normal levels.  

Type of experiments 

Most animal experiments were conducted for developing, producing, checking or verifying of 
sera,  vaccines,  drugs,  medical  or  veterinary  products  (47.3%).  Fundamental  research  was 
responsible for 44.2% of the total number of animal experiments. Potentially harming effects 
of  substances  covered  5.1%,  diagnostic  procedures  1.4%  and  education  and  training  2.0%. 
(These percentages are all based on the national statistics, hence including re-use and organ 
harvesting.) 

Licence holding establishments 

A  licence  to  perform  animal  experiments  is  obliged  in  order  to  perform  any  experiment.  In 
2005  a  total  of  80  licence-holding  establishments  were  registered  by  VWA.  Three  new 
licences were issued and one licence was terminated on request of the licence-holder.  

In  order  to  be  allowed  to  breed  an/or  deliver  laboratory  animals  a  licence  is  mandatory  as 
well. In 2005 41 establishments were licensed to breed a/o deliver laboratory animals. Most of 
which also have a licence to perform animal experiments. 

EN 

43 

   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 

240048 
116608 
7479 
5322 
3089 
8251 
334 
1049 
256 
151 
1705 
9853 
328 
2667 
4410 
0 
50 
277 
0 
13 
152 
111081 
7 
3231 
14838 
531199 

228666 
111973 
4319 
4961 
1798 
7556 
233 
528 
21 
0 
541 
4113 
114 
184 
2602 
0 
32 
223 
0 
0 
0 
15137 
2 
2877 
6906 
392786 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
540 
0 
0 
3 
0 
0 
0 
0 
0 
0 
26 
0 
0 
683 
1252 

7733 
4423 
3150 
357 
1167 
665 
30 
98 
50 
0 
0 
65 
0 
10 
81 
0 
18 
35 
0 
0 
152 
0 
0 
7 
1250 
19291 

3649 
212 
10 
4 
124 
30 
71 
423 
185 
151 
1164 
5135 
214 
2473 
1724 
0 
0 
19 
0 
13 
0 
95918 
5 
347 
5999 
117870 

5695 
3357 
46 
13 
521 
663 
14 
194 
0 
0 
858 
63 
65 
152 
429 
0 
5 
185 
0 
0 
0 
603 
0 
0 
119 
12982 

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 

44 

EN 

 
  
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.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. 

143937 
34904 
609 
811 
197 
751 
129 
166 
136 
151 
2 

5336 
221 
211 
2930 
0 
13 
196 
0 
0 
0 
34618 
6 
3151 
7919 

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) 

47957 
20931 
1553 
94 
2781 
1211 
33 
157 
108 
0 
163 

2482 
43 
194 
875 
0 
23 
71 
0 
13 
0 
28022 
0 
0 
739 

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

6114 
23100 
429 
45 
0 
3920 
6 
401 
0 
0 
0 

56 
0 
0 
0 
0 
14 
0 
0 
0 
152 
24 
0 
0 
5384 

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 

14519 
32029 
1223 
5 
0 
88 
0 
0 
0 
0 
65 

82 
0 
2179 
53 
0 
0 
10 
0 
0 
0 
333 
0 
0 
280 

16107 
2769 
3621 
4356 
0 
2222 
83 
287 
0 
0 
1473 

1725 
0 
74 
322 
0 
0 
0 
0 
0 
0 
47775 
0 
0 
0 

46 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

8704 
0 
3 
0 
0 
15 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
3 
0 
0 
0 

2710 
2875 
41 
11 
111 
44 
83 
38 
12 
0 
2 

172 
64 
9 
230 
0 
0 
0 
0 
0 
0 
306 
1 
80 
516 

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 

240048 
116608 
7479 
5322 
3089 
8251 
334 
1049 
256 
151 
1705 

9853 
328 
2667 
4410 
0 
50 
277 
0 
13 
152 
111081 
7 
3231 
14838 

EN 

 
  
2.z. 

TOTAL 

236394 

107450 

50866 

80814 

39645 

8725 

7305 

0 

531199 

EN 

47 

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. 

2819 
6140 
276 
45 
0 
2554 
6 
301 
0 
0 
0 
0 
0 
0 
0 
0 
14 
0 
0 
0 
0 
0 
0 
0 
0 
12155 

92 
5574 
0 
0 
0 
885 
0 
100 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
152 
24 
0 
0 
350 
7177 

2382 
8389 
131 
0 
0 
371 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
180 
11453 

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 

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 

48 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
322 
1558 
19 
0 
0 
6 
0 
0 
0 
0 
0 
56 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1961 

3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 
0 
479 
0 
0 
0 
104 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
583 

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 

247 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4854 
5101 

252 
960 
3 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1215 

6114 
23100 
429 
45 
0 
3920 
6 
401 
0 
0 
0 
56 
0 
0 
0 
0 
14 
0 
0 
0 
152 
24 
0 
0 
5384 
39645 

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. 

15137 
3922 
0 
0 
0 
340 
0 
68 
0 
0 
0 
277 
89 
13 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
19846 

13750 
8641 
24 
19 
0 
5 
1 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5 
0 
0 
0 
0 
0 
0 
0 
0 
22445 

48651 
2910 
0 
125 
0 
28 
0 
0 
0 
0 
0 
21 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
7 
0 
51742 

77344 
29959 
1794 
588 
2781 
1181 
24 
52 
152 
0 
0 
511 
142 
162 
61 
0 
27 
201 
0 
13 
0 
482 
0 
0 
271 
115745 

12479 
50 
145 
76 
0 
212 
69 
178 
71 
0 
165 
3673 
2 
230 
1265 
0 
0 
0 
0 
0 
0 
33870 
1 
0 
933 
53419 

167361 
45482 
1963 
808 
2781 
1766 
94 
298 
223 
0 
165 
4482 
233 
405 
1326 
0 
32 
201 
0 
13 
0 
34352 
1 
7 
1204 
263197 

EN 

49 

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. 
Pigs 
5.l. 
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: 

Footnotes: 

EN 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8 
7 
0 
0 
0 
0 
0 
0 
40 
0 
0 
0 
55 

11126 
3650 
1139 
0 
0 
34 
13 
0 
0 
0 
0 
127 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
16089 

0 
0 
7 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
26 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
33 

2803 
593 
1464 
7 
0 
280 
18 
138 
0 
0 
1402 
423 
0 
2219 
171 
0 
0 
10 
0 
0 
0 
11044 
0 
0 
280 
20852 
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. 

14929 
30483 
2234 
4354 
0 
1996 
52 
149 
0 
0 
136 
1248 
0 
26 
161 
0 
0 
0 
0 
0 
0 
37024 
0 
0 
0 
92792 

1768 
72 
0 
0 
0 
0 
0 
0 
0 
0 
0 
9 
0 
0 
10 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1859 

30626 
34798 
4844 
4361 
0 
2310 
83 
287 
0 
0 
1538 
1807 
0 
2253 
375 
0 
0 
10 
0 
0 
0 
48108 
0 
0 
280 
131680 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

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: 

50 

EN 

 
  
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

51 

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. 
6.z. 
TOTAL 
Examples: 

0 
86 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
321 
407 

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 

1905 
1581 
29 
0 
0 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
14 
0 
0 
0 
0 
24 
0 
0 
1233 
4792 
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. 

4125 
21161 
400 
45 
0 
3914 
0 
401 
0 
0 
0 
56 
0 
0 
0 
0 
0 
0 
0 
0 
152 
0 
0 
0 
3830 
34084 

84 
272 
0 
0 
0 
0 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
362 

6114 
23100 
429 
45 
0 
3920 
6 
401 
0 
0 
0 
56 
0 
0 
0 
0 
14 
0 
0 
0 
152 
24 
0 
0 
5384 
39645 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

52 

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. 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
152 
0 
0 
0 
1278 
1430 

10 
1009 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
535 
1554 

839 
3818 
18 
45 
0 
140 
6 
169 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1713 
6748 

0 
611 
0 
0 
0 
330 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
941 

EN 

2077 
0 
290 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2367 

53 

0 
0 
0 
0 
0 
167 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
167 

134 
3242 
23 
0 
0 
24 
0 
224 
0 
0 
0 

56 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
790 
4493 

236 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
236 

0 
6661 
0 
0 
0 
60 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
804 
7525 

2435 
471 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2906 

0 
4852 
0 
0 
0 
1719 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
6571 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
264 
264 

383 
2436 
98 
0 
0 
1480 
0 
8 
0 
0 
0 

0 
0 
0 
0 
0 
14 
0 
0 
0 
0 
24 
0 
0 
0 
4443 

6114 
23100 
429 
45 
0 
3920 
6 
401 
0 
0 
0 

56 
0 
0 
0 
0 
14 
0 
0 
0 
152 
24 
0 
0 
5384 
39645 

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 

0 

119 

3200 

228 

419 

6 

1469 

8.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

for 
Products/substances  or  devices 
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 

152 

144 

0 

0 

0 

0 

74 

826 

0 

0 

0 

0 

0 

0 

68 

0 

1 134 

535 

1713 

0 

0 

0 

6 

57 

66 

12 

1761 

653 

1759 

146 

0 

0 

3 

0 

0 

0 

0 

0 

79 

0 

0 

44 

0 

0 

3 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1275 

1600 

961 

0 

2878 

12155 

5338 

26 

843 

108 

830 

4179 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

157 

7177 

183 

11453 

0 

0 

0 

0 

0 

231 

165 

0 

262 

1961 

0 

0 

423 

0 

0 

583 

446 

864 

0 

0 

1150 

160 

404 

28 

804 

219 

0 

208 

0 

0 

0 

0 

264 

0 

5101 

0 

963 

1215 

evaluations 
TOTAL 

8.j. 

EN 

1430 

1554 

6748 

941 

2367 

167 

4493 

236 

7525 

2906 

6571 

264 

4443 

39645 

54 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
POLAND  

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  Ministry  of  Science  and  Higher 
Education, Department of Scientific Research. 

Comments of the Polish authorities  

In accordance with Directive 86/609/EEC regarding the protection of animals used for 
experimental  and  other  scientific  purposes,  animal  experiments  in  Poland  are 
regulated  by  the  Experiments  on  Animals  Act  (Act  of  21  January  2005  on 
experiments  on  live  animals,  Dz.U.  Nr  33,  poz.  289).  The  Minister  of  Science  and 
Higher Education is responsible for enforcing the act.  

Every  animal  experiment  to  be  performed  has  to  be  recommended  by  a  recognized 
ethical  review  committee  (Local  Commission  for  Ethics  in  Animal  Experiments 
(LKE)).  At  the  moment  18  ethical  review  committees  are  recognized.  They  are 
supervised  by  National  Commission  for  Ethics  in  Animal  Experiments  (KKE). 
Members of KKE and LKE are independent on public administration institutions and 
user  establishments.  Licenses  to  perform  animal  experiments  in  individual  user 
establishments  are  issued  by  the  Minister  of  Science  and  Higher  Education  after 
receiving positive National Commission’s (KKE) opinion.  

The data on the use of experimental animals in Poland in 2005 was collected for the 
first time, so the number of animals used cannot be compared with the figures for the 
preceding years. The data collected comply with the procedure agreed by the Member 
States  and  the  Commission  of  the  European  Communities  pursuant  to  Article  26  of 
Directive 86/609/EEC. 

The total number of animals used in experiments in Poland in 2005 was 358,829. 

No animals were re-used.  

Rodents accounted for 56,6% of all animals used – 202,983 animals.  

No primates were used.  

Cold-blooded animals (fish and amphibians) represented 15,7% of the animals used – 
56,292 animals. 

For  the  species  which  should  be  obtained  from  registered  breeding  or  supplying 
establishments  within  Poland,  over  95%  of  animals  listed  were  so  sourced  and  less 
than 4,5% were sourced outside of EC or Council of Europe member countries. 

53,23 % of the animals were used in biological studies. 

EN 

55 

   EN

 
31,67  %  of  the  animals  were  used  in  the  research,  development,  production  and 
quality control of products and devices for human medicine, dentistry and veterinary 
medicine. 

6,18 % of the animals were used in toxicological studies. 

8,93  %  of  the  animals  were  used  for  diagnosis  of  disease,  education  and  other 
purposes. 

No  animals  were  used  in  the  testing  of  cosmetics  products.  Using  animals  for  the 
purpose of testing of cosmetics products is prohibited by Polish law. 

Poland was also asked to provide some feed back to the following specific question:  

Question: 
Could PL provide some background information which could explain 
the reasons for the significant use of other carnivores, other mammals, cattle, other 
rodents,  quails,  horses  etc.,  pigs  and  other  birds  in  comparison  to  other  Member 
States? 

Almost 80% of 'other rodents' used for experiments in Poland are conducted at one of 
the  largest  academic  centres,  which  collaborates  with  international  universities  and 
research institutes. Many experiments within the framework of international research 
projects  are  performed  in  Poland.  It  is  important  to  emphasize  that  these  research 
studies  chiefly  concern  environmental  research  and  the  procedures  used  in  these 
studies  have  the  lowest  level  of  invasiveness.  The  other  20%  are  used  for 
environmental research much of which is unique to Poland and Central Europe. 

Other carnivores are used in environmental studies, the study of endangered species 
and the process of re-introducing indigenous species to Poland (eg, wolves, bears etc).  

The number of horses, donkeys and crossbreeds used in experiments is higher than in 
other  Member  States  due  to  the  Polish  tradition  of  horse-breeding.  These  include 
studying new breeding programmes, assessment of transport conditions and nutrition, 
for example. 

Poland produces a large amount of pork, beef and milk, therefore scientific research 
on pigs and cows is undertaken to maintain and improve the quality of these products.  

Use of other mammals is necessary because agriculture is a big industry in Poland and 
animal testing is needed to monitor the effects of modern farming on the environment. 
These experiments involve mainly boars, bats and European bison.  

Quails are used for toxicology tests for national as well as European companies. Other 
birds are also used for toxicological tests of pharmacological substances (required by 
Polish  law),  and  ecological  field  studies  on  bird  populations  and  the  influence  of 
agriculture on the bird population. 

EN 

56 

   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 

119158 
50988 
10731 
194 

2879 
67 
419 
14 

0 
0 
0 
0 

1470 

2772 
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

790 
32 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

3772 
538 
32 
49 

222 
54 
199 
5 

0 
0 
0 
0 

0 

0 
0 
0 
0 

0 
0 
0 
0 

126492 
51558 
10763 
243 
10826 
3101 
121 
618 
19 
6970 
681 
7358 
130 
2023 
13834 
0 
0 
0 
0 
5061 
1470 
61148 
121 
13216 
43076 
358829 

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 

57 

EN 

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

2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

Purpose versus species 

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) 

2.3 
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) 

2.7 
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. 

45285 
33154 
579 
138 
10250 
754 
24 
319 
5 
6970 
611 

6978 
60 
1796 
12969 
0 
0 
0 
0 
5058 
1033 
17194 
80 
12200 
35536 
190993 

28377 
4018 
0 
31 
0 
68 
0 
9 
0 
0 
0 

8 
6 
61 
40 
0 
0 
0 
0 
0 
0 
40126 
0 
0 
0 
72744 

20196 
5754 
7158 
0 
0 
1174 
45 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
472 
0 
0 
0 
34799 

EN 

13370 
3709 
1557 
0 
356 
147 
0 
29 
0 
0 
5 

20 
0 
72 
88 
0 
0 
0 
0 
0 
372 
120 
0 
0 
2315 
22160 

14217 
3877 
444 
70 
20 
233 
0 
133 
0 
0 
30 

13 
36 
0 
48 
0 
0 
0 
0 
0 
0 
302 
0 
0 
300 
19723 

860 
767 
21 
4 
34 
72 
2 
77 
0 
0 
35 

19 
27 
63 
53 
0 
0 
0 
0 
3 
65 
529 
41 
1016 
515 
4203 

511 
174 
8 
0 
166 
214 
0 
30 
0 
0 
0 

320 
1 
31 
595 
0 
0 
0 
0 
0 
0 
1647 
0 
0 
4410 
8107 

126492 
51558 
10763 
243 
10826 
3101 
121 
618 
19 
6970 
681 

7358 
130 
2023 
13834 
0 
0 
0 
0 
5061 
1470 
61148 
121 
13216 
43076 
358829 

3676 
105 
996 
0 
0 
439 
50 
21 
14 
0 
0 

0 
0 
0 
41 
0 
0 
0 
0 
0 
0 
758 
0 
0 
0 
6100 

58 

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. 

665 

31 

28 
6 

6 

9186 
1450 
1459 

126 

8 

24 
460 
98 

28 
9 

5 

372 

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 

4020 
975 

100 
128 

300 

29 

72 

3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 
40 

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

20 

80 

120 

13370 
3709 
1557 
0 
356 
147 
0 
29 
0 
0 
5 
20 
0 
72 
88 
0 
0 
0 
0 
0 
372 
120 
0 
0 
2315 
22160 

200 
12429 

2079 
3075 

699 

37 

0 

60 

200 

36 
665 

4995 

EN 

59 

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. 

37604 
16646 
4 

389 

7473 
550 

5 

9 

2924 
3110 

60 

8 
45 

4 

10829 
6604 

70 
20 
228 
18 

21 

152 

6151 

54643 

8037 

17942 

3546 
86 
444 

9 
148 

35 
36 
40 
5 
42 
135 

490 

500 
5516 

62376 
26996 
448 
70 
409 
293 
27 
157 
0 
35 
44 
85 
5 
67 
135 
0 
0 
0 
0 
0 
0 
642 
0 
0 
500 
92289 

EN 

60 

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 

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 

Regulatory requirements versus species 

705 
129 
20 

16 

2398 
318 
10 

501 
8 

4680 

903 

200 

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: 

8615 
5412 
5813 

300 
11 

41 

7474 

1408 

596 
76 
21 
14 

1230 

10819 

20192 

23872 
5859 
8154 
0 
0 
1613 
95 
21 
14 
0 
0 
0 
0 
0 
41 
0 
0 
0 
0 
0 
0 
1230 
0 
0 
0 
40899 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  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 

5783 
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: 

3235 

870 

0 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

61 

EN 

Footnotes: 

EN 

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

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 

Regulatory requirements versus species 

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. 
6.z. 
TOTAL 
Examples: 

3818 
1836 

8 

5662 

8290 
1357 
1557 

147 

29 

5 

372 

2279 
14036 

20 

1242 
516 

356 

20 

72 
80 

120 

13370 
3709 
1557 
0 
356 
147 
0 
29 
0 
0 
5 
20 
0 
72 
88 
0 
0 
0 
0 
0 
372 
120 
0 
0 
2315 
22160 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

36 
2442 
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. 

20 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

62 

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 
Carcinog
enicity 

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 

7370 

420 

306 
165 

56 

7.2.3 
Non lethal 
clinical signs 
methods 

152 
385 
756 

313 

60 

72 

36 

364 
1651 

300 

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. 

180 

2179 
2886 

7790 

1293 

132 

313 

36 

2315 

0 

351 

0 

36 
665 

100 
100 

6279 

EN 

63 

316 

371 

29 

35 

37 

192 

5178 
821 
8 

39 

5 

20 

88 

120 

13370 
3709 
1557 
0 
356 
147 
0 
29 
0 
0 
5 

20 
0 
72 
88 
0 
0 
0 
0 
0 
372 
120 
0 
0 
2315 
22160 

EN 

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

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.7 
Carcinog
enicity 

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.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 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

531 

7750 

946 

123 

215 

24 

711 

316 

100 

1713 

12429 

2302 

33 

20 

21 

315 

11 

3 

3 

3 

98 

224 

198 

6 

3 

3 

416 

147 

40 

5 

3075 

699 

37 

0 

20 

60 

200 

200 

528 

654 

35 

102 

665 

4341 

4995 

evaluations 
TOTAL 

8.j. 

2886 

7790 

1293 

132 

313 

36 

2315 

0 

351 

0 

665 

100 

6279 

22160 

EN 

64 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PORTUGAL  

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  “Ministério  da  Agricultura, 
Desenvolvimento  Rural  e  das  Pescas  –  Direcção  Geral  de  Veterinária”  (Ministry  of 
Agriculture,  Rural  Development  and  Fisheries  –  General  Direction  of  Veterinary  – 
Directorate for Animal Medicines and Products, Animal Welfare and Feed) 

Comments of Portuguese authorities  

1. 

Total number of animals used by species 

In  2005,  the  total  number  of  animals  used  for  experimental  and  other  scientific 
purposes in Portugal was 41621. 

Compared to the data of 2002, where the total number of used animals was 44577, it 
means that with regard to 2005 it was a slight decrease on the use of animals of 6,6%.  

As  in  the  previous  report,  Mice  are  the  most  commonly  used  species  representing 
68,04% of the total number of animals. 

The second most used group of animals was Rats (16,32%), the third is represented by 
the  cold-blooded  animals  (11,53%)  and  the  fourth  by  the  rabbits  with  1,43%.  The 
group  of  Artio  and  Perissodactyla  represent  1,11%  of  the  total  number  of  animals 
used and Carnivors represent only 0,09%.  

Rodents with rabbits represent 87,01% of the total number of animals used. 

As in other previous reports, in Portugal, non-human primates were not used. 

Comparison with the data of the previous report (data of 2002) 

The  percentages  of  classes  of  animals  used  in  2002  (44577  animals)  and  in  2005 
(41621 animals) are represented in the following table: 

of 

2002 

2005 

Class 
animals (%) 

Mice 

Rats  

Guinea-pigs 

Hamsters 
other rodents 

and 

Rabbits 

Cold-blooded 
animals 

EN 

68,04 

16,32 

0,91 

0,31 

1,43 

11,53 

62 

27,6 

1,42 

0,21 

2,04 

5,38 

65 

   EN

 
Quail  and  other 
birds 

Artio 
Perissodactyla 

Carnivors 

0,44 

0,88 

0,08 

0,27 

1,11 

0,09 

Looking  at  the  data  by  groups  of  species,  the  two  major  increases  that  happened  in 
2005 are in the use of Cold-blooded animals and of Mice.  

On the other hand, the biggest decrease was in the use of Rats.  

The percentage of Rabbits decreased in 2005 but the percentage of Hamsters slightly 
increased. 

Among  the  group  of  the  Cold-blooded  animals,  the  general  increase  was  due  to  the 
increase  on  the  use  of  Fish,  as  the  numbers  of  Reptiles  and  Amphibians  both 
decreased. 

The use of Birds decreased too and this decrease was due to the reduction on the use 
of Quail but also on Other Birds too. 

The use of Artio and Perisodactyla animals increased in 2005. The species that its use 
decreased among this group was only Goats but all the others increased.  

2. 

Number of animals used by purposes of experiments 

In 2005, the percentage of animals (total 41621) used by purposes of experiments was 
the following: 

78,78% of animals were used in Fundamental biology; 

6,78%  in  Research  and  development  for  human  medicine,  veterinary  medicine, 
dentistry; 

5,09% in Production and quality control of products and devices in human medicine 
and dentistry (1,72%) and veterinary medicine (3,37%); 

3,02% in Education and training; 

2,68% in Diagnosis of disease; 

2,26% in Toxicological and other safety evaluation; 

1,39% in Other purposes; 

Referring  to  the  use  of  species versus experimental  purposes,  the  highest  amount  of 
use of Mice and of Rats is in Fundamental biology and in Research and development 
for human medicine, veterinary medicine, dentistry.  

Comparison with the data of the previous report (data of 2002). 

The  most  significant  increase  in  2005  is  the  number  of  animals  that  were  used  for 
Fundamental biology, which increased from 64,11% in 2002, to 78,78% in 2005. 

EN 

66 

   EN

 
The other increase that occurred was in the percentage of animals used in Production 
and quality control of products and devices in human medicine and dentistry, which 
increased from 0,8% in 2002, to 1,72% in 2005. 

The use of animals in the rest of the other categories decreased, for example:  

The  percentage  of  animals  used  for  Toxicological  and  other  safety  evaluation 
decreased from 2,92% to 2,26% (from 1301 to 939 animals); 

The percentage of animals used for Education and training decreased from 4,78% to 
3,02% (from 2132 to 1258 animals); 

The percentage of animals used for Other purposes decreased from 2,41% to 1,39% 
(from 1075 to 577 animals) 

Number  of  animals  used  for  Toxicological  and  safety  evaluation  by  type 

1. 
of products 

In  2005,  the  use  of  animals  in  Toxicological  and  other  safety  evaluation  represents 
only 2,26%, which only refers to 939 animals, of a total of 41621 animals that were 
used for experimental purposes in Portugal. 

Products  or  devices  for  human  medicine  and  dentistry  and  for  veterinary  medicine 
represents  52,08% of the animal used for Toxicological and other safety evaluation; 
Potential  or  actual  contaminants  in  the  general  environment  which  do  not  appear  in 
other  columns  represents  21,30%  and  Other  toxicological  or  safety  evaluations 
represent 26,62%.  

Comparison with the data of the previous report (data of 2002). 

Compared to the data of 2002, in 2005 there was a decrease on the use of animals in 
Toxicological  and  other  safety  evaluation.  The  percentage  of  animals  used  for 
Toxicological and other safety evaluation decreased from 2,92% to 2,26% (from 1301 
to 939 animals). 

The data of 2002 refers to the same category of products that were tested in 2005.  

Products  or  devices  for  human  medicine  and  dentistry  and  for  veterinary  medicine 
represented,  in  2002,  20,67%  of  the  animal  used  for  Toxicological  and  other  safety 
evaluation; Potential or actual contaminants in the general environment which do not 
appear  in  other  columns  represented  12,45%  and  Other  toxicological  or  safety 
evaluations represent 66,88%.  

As  in  2002,  in  2005  the  other  groups  of  products/substances  were  not  tested  which 
means that, for example, there were no animals used for the purpose of evaluating the 
safety of Cosmetics or Additives in food for animal consumption. 

In  Portugal,  in  2005,  there  happened  a  decrease  in  the  number  of  animals  used  for 
Other  toxicological  or  safety  evaluation  compared  to  2002.  In  2002,  the  number  of 
animals used were 870 (66,88%) and in 2005, 250 (26,62%). 

2. 

Number of animals used for the study of diseases 

In 2005, the number of animals used for the Studies on humans and animals diseases 
was 19372, which represents 46,54% of the total number of animals (41621 animals) 
that were used. 

EN 

67 

   EN

 
The percentages of animals per type of diseases were: 

3,28% in Human cardiovascular diseases; 

24,89% in Human nervous and mental disorders; 

2,28% in Human cancer (excl. evaluation of carcino hazards); 

68,15% in Other human diseases; 

1,40% in Specific animal diseases. 

The  percentage  of  the  number  of  animals  used  for  studies  of  human  diseases 
represents 98,6% (19101 animals) of the total number of animals used for all studies 
of diseases (19372 animals). 

In 2005, the number of animals used to study animal diseases was only 271 (1,40%) 
while  in  2002,  that  number  had  been  1922,  which  means  that  in  2005,  there  was  a 
decrease on the use of animals for the study of animal diseases.  

In general terms, the proportion of animals used for the studies of diseases showed a 
slight change when compared to the 2002 data.  

In 2005, Cold-blooded animals were not used to study any diseases 

Number of animals used for Toxicological and other safety evaluations by 

3. 
the types of tests 

As pointed out earlier, in 2005, the use of animals in Toxicological and other safety 
evaluation  represents  only  2,26%,  which  only  refers  to  939  animals,  of  a  total  of 
41621 animals that were used for experimental purposes in Portugal. 

Comparison with the data of the previous report (data of 2002). 

The  percentages  of  animals  used  in  toxicity  tests  for  Toxicological  and  other  safety 
evaluation  in  2002  (1301  animals)  and  in  2005  (939  animals)  are represented in the 
following table: 

Type of tests (%) 

and 

Acute 
sub-acute 
toxicity  testing  methods 
(including limit test) 

2002 

14,37 

2005 

37,6 

Irritation/sensitization 
tests  

6,53 

27,8 

Sub-chronic  and  chronic 
toxicity 

0 

Mutagenicity 
carcinogenicity 

and 

8,84 

Reproductive 
developmental toxicity 

and 

49,19 

0 

32 

0 

EN 

68 

   EN

 
Toxicity 
aquatic 
of 
vertebrates  not  included 
in other columns 

0 

0 

Other 

21,1 

2,7 

In  2005,  the  biggest  percentage  of  use  of  animals  is  due  to  acute  and  sub-acute 
toxicity, which represents 37,6% and means that there was an increase of this type of 
tests related to the previous report (data 2002). 

The use of animals used for Reproductive and developmental toxicity tests decreased 
from 49,19% in 2002, to 0% in 2005. 

Contrary to what happened for the 25 Member States, the use of animals in 2005 for 
“Other tests” decreased from 21,1% in 2002, to 2,7% in 2005. 

Type of toxicity tests carried out for Toxicological and other safety evaluations 

4. 
of products 

As pointed out earlier, in 2005, the use of animals in Toxicological and other safety 
evaluation  represents  only  2,26%,  which  only  refers  to  939  animals,  of  a  total  of 
41621 animals that were used for experimental purposes in Portugal. 

Comparison with the data of the previous report (data of 2002) 

The numbers of animals used for Toxicological and other safety evaluation per types 
of products in 2002 (1301 animals) and in 2005 (939 animals) are represented in the 
following tables: 

Types of products (%) 

2002 

2005 

269 

689 

162 

0 

or 
Products/substances 
devices 
human 
for 
medicine  and  dentistry 
and 
veterinary 
medicine 

for 

in 

or 

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

toxicological  or 

Other 
safety evaluations 

870 

250 

In 2005, the number of animals used to test Products/substances or devices for human 
medicine and dentistry and for veterinary medicine were the following:  

300 animals in Carcinogenicity and Mutagenicity (in 2002, they were 100 animals); 

EN 

69 

   EN

 
261 animals in Irritation/sensitisation tests (in 2002, they were 85 animals); 

103 animals in Acute and sub-acute toxicity testing methods (including limit test) (in 
2002, they were 40 animals). 

25 animals in Other tests (in 2002, they were 44 animals). 

In  2005,  the  number  of  animals  used  in  the  category  Other  toxicological  or  safety 
evaluations  were  250  animals  in  Acute  and  sub-acute  toxicity  testing  methods 
(including limit test) (in 2002, they were 230 animals in Acute and sub-acute toxicity 
testing  methods  (including  limit  test)  and  640  animals  in  Reproductive  and 
developmental toxicity tests). 

EN 

70 

   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 

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 

19975 
2362 
102 
18 

349 

5838 
4236 

111 

28318 
6793 
379 
129 

594 

36 

8 
113 
4 
290 
45 

1 

112 

51 
4748 
41621 

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

49 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

2456 
195 
277 

245 

36 

50 

20 

10 

1 

12 

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 

71 

EN 

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

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. 

23396 
4249 
65 

3 

33 

272 
37 

6 

4728 
32789 

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) 

1075 
1612 

115 

19 

1 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

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) 

994 
113 
8 

1 

440 
200 
2 

261 

36 

700 

15 

977 

110 

245 

4 

69 

471 
561 
25 

25 

8 

78 
4 
8 
8 

50 
20 
1258 

265 
58 
169 
14 

25 

2 

6 

37 

1 

577 

28318 
6793 
379 
129 

594 

36 

8 

113 
4 
290 
45 

1 

112 

51 
4748 
41621 

2822 

715 

1405 

939 

1116 

EN 

72 

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. 

190 

2 

261 

36 

489 

250 

200 

440 

2 

261 

36 

200 

250 

939 

EN 

73 

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. 

66 
459 

111 

2126 
2696 

12509 
658 
2 
14 

436 
3 

2 

247 

2 

4 

15384 
3816 
2 
125 

4 

4 

636 

4822 

441 

13202 

271 

19372 

19 

18 

37 

EN 

74 

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 

700 

1677 

40 

977 

110 

220 

4 

69 

1380 

40 

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. 
Pigs 
5.l. 
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: 

Footnotes: 

EN 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

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 

700 
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: 

75 

EN 

110 

260 

4 

69 

2120 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

76 

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 

100 

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. 
6.z. 
TOTAL 
Examples: 

25 
200 

315 

2 

261 

36 

225 

614 

440 
200 
2 

261 

36 

939 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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 

100 
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: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

77 

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 

7.2.3 
Non lethal 
clinical signs 
methods 

100 

215 

2 

36 

261 

200 

100 

25 

440 
200 
2 

261 

36 

100 

217 

36 

261 

200 

100 

25 

939 

EN 

78 

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.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. 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

103 

261 

200 

100 

25 

689 

100 

100 

150 

253 

261 

200 

100 

25 

939 

250 

EN 

79 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FINLAND  

Statistical data submitted 

The statistical data have been submitted by the “ Maa – ja metsätalousministeriö Elintarvike- 
ja terveysosasto” (Ministry of Agriculture and Forestry, Veterinary and Food Department). 

Comments of Finnish authorities  

Report from Finland 2005 

In year 2005, 256826 experimental animals were used in Finland. Fish were used 20 % more 
than  in  2004.  The  total  amount  of  animals  of  other  species  used  in  experiments  remained 
essentially unchanged from the previous year. 

Due to the increase in fish use there was a 6 % increase in the total number of experimental 
animals in 2005 in comparison to 2004. In recent years fish use has varied greatly from more 
than 500 000 in years 2001 and 2002 to 78 000 in year 2004 causing a great yearly variation 
in total number of experimental animals used in Finland.  

The number of mice used in 2005 was 19 % higher than the yearly average in 2000-2004, but 
of rats 12% lower, respectively. Of all experimental animals used 60 % were rodents, and 93 
% of fish are excluded from the total, respectively. No cats were used in Finland in 2005, but 
the  number  of  dogs  used  was  increasing  third  year  in  row,  the  number  being  103  in  2005 
which is 60 % higher than the average yearly use of previous 5 years. Cattle was in 2005 used 
also increasingly in comparison to previous 5 years. In other species no tendency was seen. 

No cats, monkeys and reptiles were reported used as experimental animals in Finland in 2005. 

Major  part  (87  %)  of  the  animals  were  used  for  biological  studies  of  a  fundamental  nature. 
Animal use in 2005 for human and veterinary medicine research and quality control was 9,3 
%,  for  toxicological  and  other  safety  evaluations  0,9  %,  for  diagnosis  of  disease  0,2  %,  for 
education  and  training  1,8  %  and  other  uses  0,9  %  of  the  total  number  of  experimental 
animals  used,  respectively.  No  major  differences  in  comparison  to  the  previous  year  were 
observed. 

Preparations for a revision of the Finnish legislation concerning use of experimental animals 
proceeded to final drafts during year 2005 and was planned to be passed in 2006. 

Ministry  of  Agriculture  and  Forestry  funded  Finnish  research  for  studies  to  replace  existing 
techniques using experimental animals with alternative methods with 27 000 € in year 2005. 

EN 

80 

   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 

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

247 

1.6 
Animals coming from 
other origins 

1.7 
Re-used animals 

343 
124 

1 

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 

120636 
28358 
563 
126 
3187 
1214 
0 
103 
80 
5 
125 
1471 
73 
445 
455 
0 
0 
0 
0 
972 
0 
5773 
0 
20 
93220 
256826 

87684 
10869 

6 

500 
0 
8 
80 
0 
125 

455 
0 
0 
0 
0 
0 
0 
890 
0 

32362 
17365 
563 
120 

714 

95 

10 

100617 

51229 

247 

468 

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 

81 

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 

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

585 
1374 
79 

75 

56 

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) 

7761 
11885 
352 

467 

47 

15 

141 
4 
43 

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 

100 
100 
24 

54 

203 

380 

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. 

2.j. 
2.k. 

Other Carnivores 
Horses,  donkeys  and  cross 
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. 

111502 
13749 

126 
3187 
514 

80 

5 
110 

445 

22 
277 

972 

2515 

90011 
223515 

8 

2209 

20723 

861 

2209 

72 
2241 

317 
360 

25 
17 

1 

581 
791 
24 

82 
442 
84 

85 

18 

600 

82 
69 

178 

41 

1000 

20 
2820 
4691 

2226 

120636 
28358 
563 
126 
3187 
1214 
0 
103 
80 

5 
125 

1471 
73 
445 
455 
0 
0 
0 
0 
972 
0 
5773 
0 
20 
93220 
256826 

EN 

82 

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. 

265 
758 
79 

75 

56 

320 
616 

1233 

0 

0 

0 

0 

0 

0 

72 
72 

936 

585 
1374 
79 
0 
0 
75 
0 
56 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
72 
2241 

EN 

83 

EN 

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

Main categories versus species 

4.1 
Species 

4.2  
Human cardiovascular 
diseases 

4.3 
Human nervous and 
mental disorders 

4.5 
Other human diseases 

4.6 
Studies specific to animal 
diseases 

4.7 
Total 

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

8652 
266 

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. 

6400 
9683 

15 

12 

3629 
3408 
332 

195 

75 

218 

18885 
4118 

120 

362 

39 

7857 

16110 

8918 

23524 

37566 
17475 
332 
120 
0 
572 
0 
87 
0 
0 
0 
218 
0 
61 
6 
0 
0 
0 
0 
6 
0 
8 
0 
0 
385 
56836 

22 
6 

6 

8 

385 
427 

EN 

84 

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 

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 

Regulatory requirements versus 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: 

20 

80 

4 

171 

380 

100 
24 

50 

32 

2209 

100 
100 
24 
0 
0 
54 
0 
0 
0 
0 
0 
203 
0 
380 
0 
0 
0 
0 
0 
0 
0 
2209 
0 
0 
0 
3070 

0 

84 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  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 

2415 
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: 

551 

20 

0 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

85 

EN 

Footnotes: 

EN 

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

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 

Regulatory requirements versus species 

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. 
6.z. 
TOTAL 
Examples: 

40 

55 
127 

8 

56 

40 

246 

96 

490 
1151 
79 

67 

585 
1374 
79 
0 
0 
75 
0 
56 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
72 
2241 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

72 
168 
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. 

1787 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

86 

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 

7.2.3 
Non lethal 
clinical signs 
methods 

375 
520 

40 
17 

8 

56 

100 

170 
737 
79 

67 

0 

0 

895 

0 

0 

0 

121 

0 

0 

0 

100 

72 
72 

1053 

585 
1374 
79 
0 
0 
75 
0 
56 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
72 
2241 

EN 

87 

EN 

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

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

895 

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 

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 

121 

100 

957 

2073 

0 

0 

0 

0 

0 

0 

72 

72 

96 

96 

evaluations 
TOTAL 

8.j. 

0 

0 

895 

0 

0 

0 

121 

0 

0 

0 

100 

72 

1053 

2241 

EN 

88 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLOVENIA 

Statistical data submitted 

The statistical data have been submitted by the "Veterinary Administration of the 
Republic of Slovenia" 

Comments of Slovenian authorities  

The Slovenian national legislation on the protection of experimental animals has been 
harmonised  with  the  relevant  EU  legislation.  Experimental  animals  have  been 
regulated  under  the  Protection  of  Animals  Act  (UPB-1,  UL  RS1  20/04),  under  the 
Rules on conditions for experiments on animals (UL RS 88/06), and under the Rules 
on the Ethical Commission for experiments on animals (UL RS 84/00). 

On the basis of annual reports submitted by organisations conducting experiments on 
animals, the Veterinary Administration of the Republic of Slovenia (VARS) has been 
keeping statistical records including the data on quantities and species of animals used 
in  experiments  and  types  of  experiments  as  laid  down  in  Article  24  (2)  of  the 
Protection of Animals Act. Each user organisation employs an animal welfare expert, 
who is responsible for compiling on a specifically prescribed form a collective annual 
report on experiments conducted during the year and for submitting the report by the 
end  of  February  to  VARS.  The  form  envisaged  for  annual  reporting  includes  eight 
tables  and  as  Annex  5  constitutes  an  integral  part  of  the  Rules  on  conditions  for 
experiments on animals. 

In  the  Republic  of  Slovenia,  data  on  the  use  of  animals  in  experiments  have  been 
collected  since  1992.  In  the  period  1992  –  1996,  the  collective  number  of  animals 
used  in  experiments  ranged  on  average  up  to  33,000  animals,  in  the  period  1997  – 
1999 up to 21,000 animals, in the period 2000 – 2001 up to 16,000 animals, and in the 
period 2002 – 2004 on average up to 13,500 animals. In the light of the above it may 
be  stated  with  certainty  that  the  use  of  animals  in  experiments  in  the  Republic  of 
Slovenia has been showing a downward trend.  

In  2005,  a  collective  number  of  animals  used  for  experimental  and  other  scientific 
purposes totalled 11,991 animals. As compared to 2004, where 13,538 animals were 
used in experiments, the number of animals used in experiments in 2005 decreased by 
1,547 animals (11.4 %). This collective number of animals mostly included laboratory 
rodents (mice, rats) and rabbits.  

In  2005,  11,344  laboratory  rodents  were  used,  amounting  to  94.6  %  of  all 
experimental  animals  used,  whilst  more  laboratory  rodents  were  used  in  2004,  i.e. 
12,145 animals or 89.7 % of all experimental animals used. In 2005, 533 rabbits were 
used in experiments, amounting to 8.5 % less rabbits as compared to 2004. In 2005, a 
collective  number  of  114  other  animals  were  used,  including  in  particular  sheep, 
birds, pigs and a horse.  

1 

UL RS – Uradni list Republike Slovenija – Official Gazette of the Republic of Slovenia 

EN 

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It is evident from Table 1 showing the number and species of animals used in relation 
to their place of origin that nearly all laboratory experimental animals in 2005 came 
from breeding organisations established within the Republic of Slovenia. Mostly used 
were  laboratory  rodents  (94.6  %).  From  the  collective  number  of  experimental 
animals, the animals reused in experiments included the rabbits and dogs.  

As regards animals used in experiments for selected purposes as shown in Table 2, in 
2005, most animals were used in pharmaceutical industry in the Republic of Slovenia. 
For  the  purposes  of  research  and  development  of  products  and  devices  for  human 
medicine,  and  for  dentistry  and  veterinary  medicine,  for  the  production  and  quality 
control  of  products  and  devices  for  human  and  veterinary  medicine,  and  for 
toxicological and other safety evaluations, a total of 9,420 animals, or 78.5 % of all 
animals used (94 % laboratory rodents, 5.4 % rabbits and 0.4 % sheep), were used in 
such experiments in 2005.  

Table 3 shows that a total of 1,054 animals were used in the toxicological and other 
safety  evaluations.  A  total  of  1,009  animals  (975  laboratory  rodents  and  34  sheep) 
were  used  for  testing  products/substances  or  devices  for  human  medicine,  dentistry 
and veterinary medicine, and 45 rabbits for other toxicological or safety evaluations. 

Table 7 details the use of animals in the toxicological and other safety evaluations. In 
2005,  965  laboratory  rodents  were  used  in  the  acute  and  sub-acute  toxicity  testing 
methods, or in LD 50 and LC 50 determination, and 10 laboratory rats, 45 rabbits and 
34 sheep in other toxicological and safety evaluations. 

Table  8  shows  that  965  animals  were  used  in  the  toxicological  and  other  safety 
evaluations  for  products/substances  or  devices  for  human  medicine,  dentistry  and 
veterinary  medicine,  and  34  animals  for  other  purposes  of  toxicological  or  safety 
evaluations,  whilst  55  animals  were  used  in  tests  of  reproduction  toxicity  of 
products/substances intended for use in agriculture. 

Quality control of products and devices for human medicine, dentistry and veterinary 
medicine, and toxicological and other safety evaluations of substances are conducted 
the  requirements  of  relevant 
in  accordance  with 
Pharmacopoeias, and in accordance with the international regulations. 

the  applicable 

legislation, 

Table 5 shows that in accordance with EU legislation, including the requirements of 
the European Pharmacopoeia, 5,916 animals in total were used in the production and 
quality  control  of  products  and  devices  for  human  medicine  and  dentistry  and  for 
veterinary  medicine,  which  amounts  to  49.3  %  of  all  experimental  animals  used  in 
2005. Laboratory rodents and rabbits were used for these purposes. 

The  institutes  and  laboratories  of  the  faculties  of  human  medicine,  veterinary 
medicine,  biology  and  zootechnics  use  animals  in  the  baseline  biological  research 
studies and/or in the research and development studies, and a total of 1,888 animals 
were used for these purposes in 2005, which amounts to 15.7 % of all animals used, 
including in particular laboratory rodents (98.9 %), some dogs, sheep and birds. 

In  2005,  animals  were  used  to  a  lesser  extent  for  diagnosing  diseases  (3.1  %), 
educational and training purposes (2.3 %), and other purposes (0.1 %).  

EN 

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Table 4 shows the number and species of animals used in experiments for studies of 
diseases  in  humans  and  in  animals.  A  total  of  1,786  animals  were  used  for  these 
purposes, all for studies of diseases in humans. A total of 735 animals were used for 
studies  of  nervous  and  mental  disorders  in  humans,  422  animals  for  studies  of 
cardiovascular  diseases,  and  629  animals  for  studies  of  other  diseases.  Laboratory 
rodents were used predominantly, and some rabbits and sheep. 

the 

An important role in decreasing the number of animals used in experiments plays in 
particular the legislation, and the substitution of animals by alternative methods where 
so  required  by  law,  the  requirement  for  specific  authorisations  of  experiments, 
appropriate  staff 
institutes  and 
training,  successful  cooperation  between 
researchers at the national and international levels, as well as the active involvement 
of  animal  protection  and  welfare  societies.  A  further  important  contribution  to 
decreasing the number of animals used in experiments is the responsibility on the part 
of researchers and their improved attitude towards experimental animals as the plans 
and protocols of experiments are more precise and detailed, methods more carefully 
selected  and  experiments  more  precisely  conducted.  Further  important  factors  in 
decreasing  the  number  of  animals  used  in  experiments  particularly  in  the 
pharmaceutical  industry  include  the  interstate/international  recognition  of  results 
obtained  in  experiments  on  animals,  the  improved  biometric  methods,  improved 
initial  research  phases  of  new  substances  and  the  use  of  cell  cultures,  tissues  or 
smaller groups of animals.  

Dr. Dragica Ornik, 

Inspector – Counsellor 

Dr. Vida Čadonič Špelič, 

Chief Veterinary Officer 

EN 

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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 

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 

5 

8556 
2727 
38 

533 

15 

466 

6 

8556 
2732 
38 
0 
18 
533 
0 
15 
0 
0 
1 
16 
0 
57 
0 
0 
0 
0 
0 
0 
0 
22 
3 
0 
0 
11991 

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 

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2.1 
Species 

2.2  
Biological 
studies of a 
fundamenta
l nature 

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

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) 

2157 
293 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

Purpose versus species 

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) 

4467 
743 

466 

240 

478 
497 

45 

334 

9 

16 
1 

34 

18 

16 

6 

104 
112 
7 

2 
21 

2 

1 

16 

15 
3 

8556 
2732 
38 

18 
533 

15 

1 

16 

57 

22 
3 

760 
1087 
22 

7 

5 

7 

1888 

2450 

5676 

240 

1054 

378 

283 

22 

11991 

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. 

EN 

93 

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

3.1 
Species 

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. 

3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 

478 
497 

34 

1009 

Products versus species 

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 

45 

478 
497 

45 

34 

45 

1054 

EN 

94 

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. 

99 
323 

735 

426 
157 
22 

16 

8 

525 
1215 
22 

16 

8 

422 

735 

629 

1786 

EN 

95 

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 

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 

Regulatory requirements versus 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: 

4707 
743 

466 

4707 
743 

466 

5916 

5916 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  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: 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

96 

EN 

Footnotes: 

EN 

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

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 

Regulatory requirements versus species 

478 
487 

0 

10 

45 

34 

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. 
6.z. 
TOTAL 
Examples: 

478 
497 
0 
0 
45 
0 
0 
0 
0 
0 
0 
0 
34 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1054 

0 

965 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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 

89 
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: 

0 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

97 

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 

7.2.3 
Non lethal 
clinical signs 
methods 

478 
487 

10 

45 

34 

965 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

89 

478 
497 
0 
0 
0 
45 
0 
0 
0 
0 
0 

0 
0 
34 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1054 

EN 

98 

EN 

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

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

965 

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 

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 

34 

999 

55 

55 

0 

0 

0 

0 

0 

0 

0 

evaluations 
TOTAL 

8.j. 

965 

0 

0 

0 

0 

0 

0 

0 

0 

0 

55 

0 

34 

1054 

EN 

99 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLOVAKIA 

Statistical data submitted 

The statistical data have been submitted by the State Veterinary and Food 
Administration of the Slovak Republic, Botanická 17, 842 13 Bratislava 

Comments of Slovakian authorities  

National  comments  to  the  statistical  evaluation  of  data  concerning  the  number  of 
experimental animals used in experiments in the year 2005 in the Slovak Republic. 

The  State  Veterinary  and  Food  Administration  of  the  Slovak  Republic  (hereinafter 
"SVFA  SR")  as  a competent  authority  of  the  Slovak  Republic  in  the  matter  of 
approval of establishments for breeding and use of animals for experimental and other 
scientific  purposes is comprised of 8 Regional Veterinary and Food Administrations 
(hereinafter RVFA) and 40 District Veterinary and Food Administrations (hereinafter 
DVFA). All the workers of the veterinary administration in the field of animal welfare 
are veterinarians.  

The SVFA SR approves in compliance with Article 6 of the Act No.488/2002 Coll. on 
Veterinary Care and on Amendment to Some Laws as later amended ( hereinafter Act 
No.  488/2002  Coll.)  and  in  compliance  with  Article  7  and  Article  13  and  17  of  the 
Ordinance  of  the  Government  of  Slovak  Republic  No.  289/2003  Coll.,  laying  down 
requirements  for  the  protection  of  animals  used  for  experimental  purposes  or  other 
scientific purposes as later amended (hereinafter "Ordinance of the Government of the 
Slovak  Republic  No.  289/2003  Coll.".),  experimental,  breeding  and  supplying 
establishments  and  all  the  experiments  performed  using  animals.  Each  approved 
establishment is kept by the SVFA SR on the list of approved establishments on the 
website  of  SVFA  SR  www.svssr.sk.  in  compliance  with  Article  37  of  the  Act  No. 
488/2002 Coll. 

Approval  of  all  kinds  of  establishments  is  performed  by  the  SVFA  SR  based  on 
affirmative  standpoint  on  assessment  of  the suitability  of  establishment  for  housing, 
breeding,  care  and  the  use  of  animals  for  experiments,  issued  by  the  RVFA)  in 
compliance with Article 12 and 16 of the Ordinance of the Government of the Slovak 
Republic  No.289/2003  Coll.  The  RVFA  issues  a  standpoint  based  on  results  of  a 
control  performed  directly  in  the  establishment  for  the  purpose  of  assessment  of 
observance  of  requirements  for  approved  establishment,  which  are  laid  down  in  the 
Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. Controls of 
establishments  are  performed  by  veterinarians  -  RVFA  animal  welfare  inspectors. 
Animal welfare inspectors shall be obliged, in compliance with Article 7 of the Act 
488/2002  Coll.  and  Article  21  of  the  Ordinance  of  the  Government  of  the  Slovak 
Republic  No.  289/2003  Coll.  to  perform  minimum  once  a  year  non-discriminatory 
controls  of  all  approved  establishments  for  the  purpose  of  control  of  observance  of 
requirements for approved establishment which are laid down in the Ordinance of the 
Government  of  the  Slovak  Republic  No.  289/2003  Coll.  The  SVFA  SR,  as  a 
competent  authority,  trained  theoretically  and  also  practically  all  the  animal  welfare 

EN 

100 

   EN

 
inspectors  for  the  performance  of  the  control.  Controls  are  performed  based  on 
methodical  instructions  and  check  lists  worked  out  by  the  competent  authority  in 
compliance with requirements laid down in the Ordinance of the Government of the 
Slovak Republic No. 289/2003 Coll. and in the Act 488/2002 Coll. 

The SVFA SR approved in the year 2005, based on applicant’s applications a total of 
7  new  experimental  establishments, 1  breeding  establishment  for  breeding  of 
experimental animals. 

Total number of establishments in the Slovak Republic in the year 2005 

Kind of establishment 

Number 

Experimental establishment 

Experimental establishment with breeding 
of animals for own use 

Breeding establishment 

Supplying establishment 

Total: 

43 

20 

7 

1 

71 

The  SVFA  SR  approves  the  experiments  performed  upon  animals  based  on  the 
application  for  approval  of  the  experiment  submitted  by  an  applicant  -  approved 
experimental establishment. Each application for approval of an experiment shall be 
submitted  by  an  applicant  in  compliance  with  Article  20  of  the  Ordinance  of  the 
Government of the Slovak Republic No. 289/2003 Coll. in order to be judged by the 
ETHIC  COMMISSION.  Each  approved  experimental  establishment  shall  have 
established  its  own  ethic  commission  comprised  of  minimum  5  members,  out  of 
which  1/3  must  not  be  dependent  from  the  experimental  establishment.  Ethic 
commission,  on  the  submitted  project  of  an  experiment,  shall  assess  justification  of 
each experiment, use of the animals in the experiment and specification of species and 
number of animals in the experiment. An applicant may submit his/her project of an 
experiment for approval by the SVFA SR only after recommendation for submission, 
issued by the ethic commission. The SVFA SR has in compliance with the Act No. 
71/1967  Coll.  On  Administrative  Proceedings  (Administrative  Codex)  minimum  30 
days for assessment of an application for approval of the experiment. The SVFA SR. 
as  a  competent  authority  shall  issue  a  decision  by  which  the  performance  of  the 
experiment may be approved or refused. In approval of the experiment, the SVFA SR 
shall  assess  the  conformity  of  purpose  of  the  experiment  (3R),  methods  of 
performance  of  the  experiment,  origin  of  experimental  animals,  handling,  care  and 
housing  of  experimental  animals  with  provision  laid  down  in  the  Ordinance  of  the 
Government  No.  289/2003  Coll.,  in  compliance  with  the  valid  legislation  in  the 
Slovak Republic and in the European Union. The SVFA SR established, based on the 
Article 8 of the Ordinance of the Government of the Slovak Republic No. 289/2003 
Coll. advisory body of the chief veterinary officer the members of which are scientific 
workers  in  the  said  branch.  The  SVFA  SR  in  case  of  the  need  of  professional 
consultation concerning the aim of the experiment, the need of use of the animals in 

EN 

101 

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the experiment and the number of used animals shall ask the members of the advisory 
body for opinion - to the submitted application for approval of the experiment- with 
observance  of  rules  of  personal  data  protection  and  protection  of  data  with  signs  of 
trade secret or intellectual property. 

To  the  Table  No.  1  most  of  experimental  animals  originate  in  domestic  breeding 
establishments  or  in  experimental  establishments  with  breeding  of  animals  for  own 
use.  As  far  as  foreign  suppliers  are  concerned,  the  animals  originate  mainly  in  the 
Czech Republic, Hungary, Germany, Poland and France. 

To  the  Table  No.  2  The  SVFA  SR  approved  273  experiments  with  use  of 
experimental animals and suspended the proceeding in 10 applications for approval of 
the experiment in the year 2005. The total number of used animals does not reflect the 
number  of  approved  experiments,  because  in  number  of  used  experimental  animals 
also the animals are included which were used in the year 2005 from the experiments, 
approved in the year 2003, 2004 for the period of 2-3 years. In the column 2.8, in total 
7 experiments as pre-experiments for introduction of surgical methods and practices 
in the course of performance of main experiments were approved. 

Number of approved experiments in the Slovak Republic for the year 2005 

Dividing  of  experiments  based  on  the  Table  No.2  (number  of  animals  used  in  the 
experiment  for  a  various  purpose)  from  the  statistical  notification  of  the  number  of 
used animals  

Kind  of  experiment–  purpose  of  the 
experiment 

Number of experiments performed 

2.2. Basic research 

2.3.  Research  and  development  of 
products and devices for human medicine 
and veterinary medicine and dentistry  

2.4.  Production  and  control  of  quality  of 
products and devices for human medicine 
and dentistry 

2.5.  Production  and  control  of  quality  of 
products  and  devices 
for  veterinary 
medicine 

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

2.7. Disease diagnostics 

70 

79 

5 

10 

62 

25 

EN 

102 

   EN

 
2.8. Education and training 

2.9. Other 

Total 

7 

15 

273 

To  the  Table  No.3  In  the  column  3.2  most  animals  were  used  for  evaluation  of 
products and substances for human medicine. In the column 3.3 the animal was used 
for  control  of  products/substances  used  in  agriculture-  mainly  pesticide,  herbicide 
products. In the column 3.4 the animals used for control of various chemical products/ 
substances being a part of oils, lubricants and rude materials are indicated. 

To  the  Table  No.  4  Explanation  to  the  column  4.5.  Animals  were  used  for  the 
purpose  of  investigation  of  immune  systems,  infectious  diseases,  and  metabolism 
disorders in man and in the column 4.6 in animals. 

To  the  Table  No.  5  In  the  Slovak  Republic  the  experiments  upon  animals  are 
performed in compliance with the valid Slovak legislation, in which the legal acts of 
the  European  Communities  and  the  European  Union  are  incorporated.  The 
experiments  are  performed  in  compliance  with  the  valid  legislation  of  the  European 
Pharmacopoeia, in the column 5.5 the experiments were performed according to the 
valid national legislation e.g. STN EN ISO standards. In the column 5.7 the methods 
in  control  of  human  products/substances  were  used  that  were  created  by  the 
experimental  establishment  as  a  modified  method  based  on 
the  approved 
pharmacopoeial methods or as a new individual method. 

To the Table No. 6 The Slovak Republic has elaborated the valid legislation for the 
control  of  drugs  -  Act  No.  140/1998  Coll.  Act  On  Medicinal  Products  and  Medical 
Devices as amended, for the control of chemical substances and preparations the Act 
No. 163/2001 Coll. On Chemical Substances and Preparations, Decree of the Ministry 
of  Economy  No.  2/2005  Annex  5  Part  B  Methods  B,  that  are  analogous  to  OECD 
methods.  In  the  column  6.3  the  number  of  animals  used  in  compliance  with  the 
European  Pharmacopoeia  are  indicated,  in  the  column  6.4  a  total  of  4  rabbits  were 
used  in  the  experiment  of  eye  irritation  in  control  of  a  substance  used  mainly  in 
agriculture. 

To the Table No. 7 In the column7.2.1. the animals were used only in limit test. Tests 
were  performed  mainly  by  methods  OECD  TG  402,  403.  In  the  column  7.2.2.  the 
tests  OECD  TG  423,  B.1  tris  were  performed.  In  the  column  7.2.3  mainly  tests  in 
compliance with OECD TG 407, 420, tolerance studies were performed. 

In  compliance  with  Article  17  para  4  of  the  Ordinance  of  the  Government  of  the 
Slovak Republic No. 289/2003 Coll. each approved establishment shall be obliged, in 
order to maintain the approval, to submit yearly by the end of January for the previous 
year to the SVFA SR a notification on the form according to the specimen laid down 
in the Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. on the 
number  of  used  animals.  Approved  establishments  shall  be  obliged  to  keep  records 
about  the  number of  used  GMO  animals in the experiment.  Based on collected data 
the SVFA SR shall yearly work out a notification about the activity of the SVFA SR 
in  which  the  numbers  of  approved  establishments  and  approved  or  refused 

EN 

103 

   EN

 
experiments as well as numbers and species of used animals in the experiment for the 
respective year are published.  

Controls  of  establishments  are  performed  by  veterinarians  -  RVFA  animal  welfare 
inspectors. Animal welfare inspectors shall be obliged, in compliance with Article 7 
of the Act 488/2002 Coll. And Article 21 of the Ordinance of the Government of the 
Slovak  Republic  No.  289/2003  Coll.  to  perform  minimum  once  a  year  non-
discriminatory  controls  of  all  approved  establishments  for  the  purpose  of  control  of 
observance of requirements for approved establishment indicated in the Ordinance of 
the  Government  of  the  Slovak  Republic  No.  289/2003  Coll.  The  SVFA,  as  a 
competent  authority,  has  trained  theoretically  and  also  practically  all  the  animal 
welfare  inspectors  for  performance  of  the  control.  Controls  are  performed  based  on 
methodical  instructions  and  check  lists  worked  out  by  the  competent  authority  in 
compliance  with  requirements  indicated  in  the  Ordinance  of  the  Government  of  the 
Slovak Republic No. 289/2003 Coll. and in the Act 488/2002 Coll. 

Control of animal welfare in approved establishments is performed by animal welfare 
inspectors – veterinarians in compliance with Article 8 para 3 letter b) and Article 21 
of the Act No. 488/2002 Coll. and of the Ordinance of the Government of the Slovak 
Republic  No.  289/2003  Coll.  Controls  of  animal  welfare  are  non-discriminatory, 
performed  minimum  once  a  year  in  each  approved  establishment.  The  competent 
authority trained all the inspectors for performance of animal welfare inspection and 
worked  out  the  methodical  instruction  according  to  which  the  animal  welfare 
inspections  are  performed.  The  purpose  of  animal  welfare  control  in  approved 
establishments  is  a  control  of  observance  of  requirements  laid  down  in  the  Act  No. 
488/2002  Coll,  Ordinance  of  the  Government  of  the  Slovak  Republic  No.  289/2003 
Coll. Animal welfare inspectors shall control conformity of the test performance in an 
approved experimental establishment with a decision issued by the SVFA SR on the 
approval  of  the  experiment.  Finding  of  infringements  laid  down  in  the  Act  No. 
488/2002  Coll.,  Article  21  and  44  and  in  the  Ordinance  of  the  Government  of  the 
Slovak Republic No. 289/2003 Coll. is classified as an administrative delict for which 
a penalty may be imposed on a legal or natural person in compliance with Article 45 
of the Act No. 488/2002 Coll. 

The SVFA SR performs theoretical and practical trainings of all workers of veterinary 
administration in performance of control with regard to housing, care and protection 
of experimental animals. 

The competent authority performs consulting services for public in the field of animal 
welfare,  organizes  trainings  for  workers  of  approved  establishments  the  purpose  of 
which is interpretation of the valid legislation of the Slovak Republic in the field of 
animal  welfare.  The  SVFA  SR  organizes  also  seminars  and  lectures  aimed  at 
protection  of  experimental  animals  used  for  experimental  purposes.  In  compliance 
with  the  Article  35  of  the  Act.  No.  488/2002  Coll.  the  animal  owner,  keeper  and 
dealer shall be obliged to educate demonstrably the persons handling the animals so 
that  such  persons  must  avoid  from  any  acts  that  might  cause  injury  or  any  other 
damage to the health of animals or unnecessary suffering thereof.  

Prof. Jozef Bíreš, DVM, DrSc 

EN 

104 

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Chief Veterinary Officer 

EN 

105 

   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 

51 

5729 
1768 
80 

150 

6 

126 

9246 
4942 
514 

632 

251 

14975 
6761 
594 
0 

782 
0 
6 
0 

0 
0 
0 
0 

251 

23369

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 

106 

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 

2.3 
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) 

2433 
341 
122 

39 

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 

117 

116 

161 

482 

91 

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

440 
1015 
84 

159 

6 

3766 
292 

100 
50 
3 

222 
206 
17 

178 

3 

18 

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. 

7415 
4857 
252 

133 

251 

14975 
6761 
594 
0 
0 
782 
0 
6 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
251 
0 
0 
0 
23369 

12908 

2935 

394 

573 

1704 

4236 

156 

463 

EN 

107 

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 

6 

75 

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 

3 

50 
121 

120 
514 

270 
296 
84 

66 

6 

10 

71 

9 

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. 

440 
1015 
84 
0 
0 
159 
0 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1704 

722 

181 

705 

0 

0 

6 

84 

0 

6 

EN 

108 

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. 

29 
1944 
38 

2787 
1573 

59 

623 
181 

8 

1497 

8677 
1792 
336 

283 

251 

2011 

4419 

812 

11339 

1497 

13613 
5490 
374 
0 
0 
350 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
251 
0 
0 
0 
20078 

EN 

109 

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 

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 

Regulatory requirements versus species 

460 

107 

77 

116 

62 

5 

140 

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: 

599 
0 
116 
0 
0 
252 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
967 

0 

567 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  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 

202 
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: 

193 

0 

5 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

110 

EN 

Footnotes: 

EN 

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

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 

Regulatory requirements versus species 

120 
669 

89 

6 

320 
346 
84 

66 

4 

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. 
6.z. 
TOTAL 
Examples: 

440 
1015 
84 
0 
0 
159 
0 
6 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1704 

884 

816 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

4 

0 

0 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

111 

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 

7.2.3 
Non lethal 
clinical signs 
methods 

100 
6 

60 
285 

218 

16 

222 
4 

43 

6 

159 
80 

100 

88 

160 

120 
25 

12 

106 

345 

275 

234 

239 

88 

100 

0 

0 

160 

0 

0 

157 

440 
1015 
84 
0 
0 
159 
0 
6 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1704 

EN 

112 

EN 

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

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

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 

50 

50 

6 

320 

89 

11 

80 

160 

12 

722 

25 

8 

46 

124 

147 

14 

145 

19 

69 

100 

54 

30 

19 

181 

120 

705 

0 

0 

6 

84 

0 

6 

6 

evaluations 
TOTAL 

8.j. 

106 

345 

275 

234 

239 

88 

100 

0 

0 

160 

0 

0 

157 

1704 

EN 

113 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SWEDEN  

Statistical data submitted 

The  statistical  data  have  been  submitted  by  the  National  Board  for  Laboratory 
Animals. 

Comments of Swedish authorities  

Additional comments and remarks  on the  Swedish statistical records over used 
laboratory animals 2005. 

The  deadline  for  submitting  the  statistical  records  covering  the  use  of  laboratory 
animals during 2005 to the EU commission was in July 2006. Most researchers were 
prompt  and  submitted  their  reports  in  March,  although  some  were  as  late  as  May- 
June despite several reminders from the Swedish Animal Welfare Agency (SAWA). 

Electronical statistical form and database 

During  2006  SAWA  has  developed  an  electronically  statistical  reporting  form  that 
will give the researcher a possibility to submit the statistical records electronically to a 
computer  base.  SAWA’s  goal  is  that  this  will  make  it  easier  for  the  researcher  to 
submit  the  statistical  records  and  also  that  it  will  give  the  authority  an  excellent 
opportunity to handle, analyze and present the statistical records more easily. 

86/609/EEC Directive 

According  to  the  EU  definition  (directive  86/609/EEC)  the  number  of  laboratory 
animals used during 2005 in Sweden reached about 505 600. This is approx. a 12 % 
increase  (about  58  000  animals)  compared  to  2004.  Three  kinds  of  animals  were 
predominately  used  in  animal  experimentation,  the  mice,  the  rat  and  fish.  Indeed, 
these three groups comprised about 90 % of all laboratory animals used during 2005. 
The  increase  in  the  use  of  mice  is  probably  due  to  increased  use  of  genetically 
modified  animals.  The  large  number  of  fish  used  is  mainly  explained  by  tagging  of 
fish in assessment studies. The increase in the use of mice as a laboratory animal is an 
ongoing trend that has been consistent during the last 10 year period.  

Whereas, a clear decrease can be seen in the use of guinea pigs and rabbits throughout 
the 1990s, this may be due to new techniques of producing antibodies, using in vitro 
production instead of whole animals.  

Diagram 1.  

Illustrating the use of laboratory animals in Sweden during 2005 according to the EU 
directive. Sorted in different reporting categories.  

EN 

114 

   EN

 
39%

44%

17%

universities

Pharm aceuticalc
om panies

Other
authauritiess

Specific use of animals 

As  in  previous  years  most  laboratory  animals  were  used  in  either  fundamental 
biological research (43%) or in development of product/devices (17%) used in human 
or  veterinary  medicine.  During  2005,  3%  of  the  animals  were  used  in  toxicological 
research,  and  finally,  less  than  1%  of  the  total  numbers  of  laboratory  animals  were 
used  for  diagnosing  diseases.  The  most  common  animals  used  in  toxicological 
research are mice, rats and fish and to lesser extent dogs and rabbits. Mammals were 
mostly  used  in  experiments  concerning  products/substances  or  devices  relating  to 
human  medicine,  dentistry  and  veterinary  medicine,  fish  are  mainly  used  in  the 
evaluation of hazardous environmental substances. 

Reused animals 

During 2005, 209 animals were reused in experiments according to the EU directive. 
This  is  a  slight  increase  compared  to  2004  when  168  animals  were  reused.  Of  the 
animals reused approx. 90 % were dogs (150 animals). To a much lesser extent old 
world monkeys and rabbits were reused, 28 and 31 respectively.  

Tendencies in Sweden 

From  1990  until  2002  the  mean  number  of  laboratory  animals  used  in  Sweden  was 
about 315 000 with the highest number 1994 (approx. 351 000) and the lowest 1997 
(267 000). From 2003-2005 there has been a large increase in the number of animals 
used.  This  is  mainly  due  to  the  fact  that  tagging  of  fish  for  assessment  studies  has 
been included as an animal experiment. After discussions with the Swedish Board of 
Fisheries,  SAWA  decided  to  include  tagging  of  fish  as  an  animal  experiment.  The 
mean number during 2003-2005 is about 489 000 animals where the mean number of 
tagged fish is approx. 160 000. 

The  reasons  behind  these  fluctuations  during  the  last  decade  are  hard  to  speculate 
about. It may just be due to natural fluctuations and/or reflect the status of high or low 
economy in Sweden. However, one clear tendency is the decrease of rats throughout 
the  1990s.  In  1990  approx.  160  000  rats  were  used  according  to  the  EU  directive. 
Whereas, during the year 2005 the number of rats in experiments is down to 83 000, 
an almost 50 % decrease. On the other hand, the use of mice as laboratory animals has 

EN 

115 

   EN

 
 
increased  throughout  the  1990s;  this  rise  is  probably  due  to  the  increased  use  of 
transgenic technique(s).  

Swedish definition 

Apart from the information, Sweden also collects its own statistical data on other use 
of  laboratory  animals.  According  to  Swedish  legislation  all  use  of  animals,  which 
have a scientific purpose, should be recorded. Therefore, this statistical data includes 
all animals  used in  behaviour  studies,  feeding  trials or  animals being  euthanized  for 
the use of their tissues and organs. During 2005 about 767 000 animals were reported 
according  to  this  definition.  The  dominating  animals  were  bird,  mice,  rats,  fish  and 
pigs. This is an increase with nearly 208 000 animals compared with the figures in the 
year 2004 and is mainly due to increased use of birds and fish. The increase in birds is 
due  to  a  large  behavioural  study  on  hens  and  the  use  of  roosters,  i.e.  comb  from 
roosters for the production of hyaloronic acids. The reason behind the increase in fish 
is that the Swedish Board of Fisheries performed a large feeding study with the goal 
of increasing the survival of fish released from hatcheries. 

Fish assessment 

Apart from the categories described above, Sweden also collects statistical records on 
fish used in assessment studies. That is fish that are  caught by trawling, netting etc. 
During 2005 the number of fish in this category was approx. 6 356 000  

Diagram  2.  The  use  of  laboratory  animals  in  Sweden  according  to  86/609/EEC 
directive 40% (approx. 505 000) and the Swedish definition 60% (approx. 767 000) 

40%

Sw edish
definition

EU Directives

60%

Transgenic animals 

The  Swedish  statistical  records  do  not  separate  the  use  of  transgenic  animals  from 
other  laboratory  animals.  In  agreement  with  EU  directive,  Sweden  does  not  regard 
breeding of transgenic stocks as an experiment in it self. However, it is regarded as an 
experiment when transgenic animals are used in experiments or when new transgenic 
strains are created. 

Conclusions 

EN 

116 

   EN

 
 
The  overall  impression  is  that  the  use  of  laboratory  animals  according  to  the  EU 
directive  shows  an  increase  when  comparing  the  year  2005  with  the  numbers  used 
during 2004. The effect(s) is most obviously when comparing the use of animals by 
the  universities  and  other  authorities.  This  is  probably  due  to  the  fact  that  the  new 
animal  facilities  where  ready  and  in  full  operation  during  2005  and  of  course  the 
tagging  of  fish.  During  the  same  period  the  Swedish  pharmaceutical  industries  also 
show a slight  increase in the use of laboratory animals (approx: 7000 animals). The 
reason  behind  these  fluctuations  difficult  speculate  about  it  may  just  be  a  fact  of 
natural fluctuations. 

EN 

117 

   EN

 
1.1 
Species 

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. 

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) 

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 

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

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) 

152 004 

51 536 
1 923 
63 

1 690 
175 
1 035 
47 

0 
12 
1 
0 

0 

58 954 

31 692 
91 
104 

422 
0 
47 
0 

0 
0 
18 
0 

0 

0
0 
0 
0 

0 
0 
0 
0 

0 
0 
0 
0 

0 

2 769 

93 
0 
0 

0 
45 
84 
0 

0 
0 
44 
0 

0 

28 
0 
150 
0 

0 
0 
31 
0 

213 727 

83 321 
2 014 
167 
1 269 
2 112 
220 
1 166 
47 
163 
650 
2 722 
23 
256 
727 
0 
12 
63 
0 
639 
0 
7 838 
0 
5 496 
183 049 
505 681 

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 

118 

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. 

152 796 
47 396 
578 
53 
401 
1 053 
138 
370 
47 
71 
13 

1 495 
0 
132 
315 
0 
0 
52 
0 
489 
0 
5 689 
0 
5 419 
3 146 
219 653 

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) 

54 941 
30 220 
956 
104 
868 
472 
9 
317 
0 
0 
0 

241 
0 
27 
33 
0 
0 
11 
0 
0 
0 
245 
0 
77 
0 
88 521 

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 

68 
80 
443 
0 
0 
46 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
0 
652 

54 
0 
17 
0 
0 
2 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
73 

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

2 246 
4 460 
0 
0 
0 
347 
0 
441 
0 
0 
0 

0 
0 
0 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
8 667 
16 173 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

65 
0 
0 
0 
0 
2 
51 
15 
0 
0 
7 

260 
0 
0 
29 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
429 

1 128 
943 
6 
10 
0 
35 
0 
3 
0 
0 
570 

375 
0 
1 
340 
0 
0 
0 
0 
0 
0 
1 011 
0 
0 
577 
4 999 

2 429 
222 
14 
0 
0 
155 
22 
20 
0 
92 
60 

351 
23 
96 
10 
0 
0 
0 
0 
150 
0 
878 
0 
0 
170 659 
175 181 

213 727 
83 321 
2 014 
167 
1 269 
2 112 
220 
1 166 
47 
163 
650 

2 722 
23 
256 
727 
0 
12 
63 
0 
639 
0 
7 838 
0 
5 496 
183 049 
505 681 

EN 

119 

EN 

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

3.1 
Species 

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. 

Products versus 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 

1 042 
4 460 

347 

441 

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 

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

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 

159 
0 

1 045 
0 

0 

0 

0 

0 

0 

0 

0 

0 

12 

0 

0 

0 

0 

0 

0 

0 

0 

0 
6 302 

300 
300 

0 
0 

0 
0 

0 
0 

0 
0 

0 
0 

8 367 
8 526 

0 
1 045 

3.11 
Total 

2 246 
4 460 
0 
0 
0 
347 
0 
441 
0 
0 
0 
0 
0 
0 
0 
0 
12 
0 
0 
0 
0 
0 
0 
0 
8 667 
16 173 

EN 

120 

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. 

33 843 
2 877 
0 
0 
0 
22 
0 
0 
0 
0 
0 
0 
0 
17 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
36 759 

27 196 
6 771 
344 
66 
77 
373 
0 
128 
0 
0 
0 
534 
0 
0 
10 
0 
0 
1 
0 
0 
0 
0 
0 
30 
0 
35 530 

30 212 
27 216 
485 
0 
0 
115 
52 
18 
33 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
87 
0 
58 218 

81 523 
39 155 
760 
91 
1 192 
900 
0 
145 
14 
0 
0 
978 
0 
40 
0 
0 
0 
56 
0 
0 
0 
80 
0 
0 
1 020 
125 954 

19 919 
0 
17 
0 
0 
2 
145 
392 
0 
0 
0 
370 
0 
0 
358 
0 
0 
0 
0 
0 
0 
545 
0 
0 
1 000 
22 748 

192 693 
76 019 
1 606 
157 
1 269 
1 412 
197 
683 
47 
0 
0 
1 882 
0 
57 
368 
0 
0 
57 
0 
0 
0 
625 
0 
117 
2 020 
279 209 

EN 

121 

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 

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 

Regulatory requirements versus 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: 

80 

68 

406 

42 

54 

54 

6 

15 

122 
80 
460 
0 
0 
48 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
15 
0 
0 
0 
725 

0 

80 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  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 

129 
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: 

516 

0 

0 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

122 

EN 

Footnotes: 

EN 

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

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 

Regulatory requirements versus species 

1 404 

2 246 
4 460 

347 

441 

12 

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. 
6.z. 
TOTAL 
Examples: 

842 
4 460 

347 

441 

7 510 
13 600 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

1 157 
2 561 
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. 

12 

8 667 
16 173 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

123 

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. 
7.b. 
7.c. 
7.d. 
7.e. 
7.f. 
7.g. 
7.h. 
7.i. 
7.j. 
7.k. 

Rats 
Guinea-Pigs 
Hamsters 
Other Rodents 
Rabbits 
Cats 
Dogs 
Ferrets 
Other Carnivores 
Horses,  donkeys  and  cross 
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 

265 

7.2.3 
Non lethal 
clinical signs 
methods 

462 
3 229 

36 

383 

165 
405 

165 

263 

51 

48 

339 
232 

2 246 
4 460 

347 

441 

18 

1 045 

35 
113 

200 

40 

12 

0 

265 

4 110 

0 

1 045 

0 

200 

200 

3 570 
3 998 

570 

2 850 
2 949 

2 112 
2 112 

135 
724 

8 667 
16 173 

EN 

124 

EN 

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

8.1 
Products 

8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 

8.3 
Skin 
irritation 

8.4 
Skin 
sensitisatio
n 

8.5 
Eye 
irritation 

Types of tests versus products 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

265 

4 110 

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 

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 

165 

200 

428 

446 

99 

589 

6 302 

300 

1 045 

300 

0 

0 

0 

1 045 

0 

35 

3 570 

124 

2 550 

2 112 

135 

8 526 

0 

evaluations 
TOTAL 

8.j. 

0 

265 

4 110 

0 

0 

0 

200 

200 

3 998 

570 

3 994 

2 112 

724  16 173 

EN 

125 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
UNITED KINGDOM  

Statistical data submitted 

The  United  Kingdom  statistical  data  for  2005  were  prepared,  quality  assured  and 
submitted by the "Home Office".  

Within  the  United  Kingdom  (UK),  Great  Britain  (GB)  and  Northern  Ireland  (NI) 
publish separate, annual statistical reports based largely on the number of procedures 
started  rather  than  numbers  of  animals  used.The  2005  data  collection  process  was 
100% complete.  

In  accord  with  our  established  practice  the  UK  figures  presented  here  have  been 
recompiled  from  the  original  data  in  terms  of  animal  numbers  for  the  classes  of 
animal use recorded in the EU statistical tables. It should be noted that the UK also 
regulates,  and  the  UK  domestic  statistical  reports  enumerate,  animals  bred  for  the 
maintenance of colonies of genetically modified or harmful mutant animals, and that 
category  of  animal  use  largely  accounts  for  the  differences  in  the  figures  in  the 
original GB & NI publications and those in this EU report. 

Comments of United Kingdom authorities  

In the UK, just over 1.87 million animals were used for the first time in procedures 
started in 2005, a rise of 57,000 on the number reported for 2002.  

1,463,565 (78%) of the animals used were mice and rats. 

Cold-blooded  animals  (fish,  amphibia,  and  reptiles)  accounted  for  203,173  animals, 
11% of the animals used. 

Cats,  dogs,  equidae  and  non-human  primates  are  accorded  special  protection  in  the 
UK  and  collectively  amounted  to  9,104  animals,  0.5%  of  the  animals  used  –  a 
reduction of 841 compared with 2002. 

Non-human primates accounted for 3,115 animals, 0.16% of animals used – 58 fewer 
than in 2002. 

99%  of  the  animals  that  must  be  sourced  from  approved  breeders  or  suppliers 
originated from UK registered breeding or supplying establishments. Less than 0.5% 
were sourced outside of EC or Council of Europe member countries. 

974,046  animals  (52%)  were  used  for  fundamental  biological  studies,  research  and 
development relating to human medicine, dentistry and veterinary medicine. 

Toxicological or other safety evaluation used 248,610 animals (13%) – a reduction of 
73,323 since 2002. 

EN 

126 

   EN

 
There  was  a  marked  reduction  in  the  number  of  animals  used  to  satisfy  national 
legislation  specific  to  a  single  member  state,  with  the  majority  of  the  animal  use 
(72%) being to fulfil multinational regulatory requirements. 

110,384  animals  (6%)  were  used  for  the  production  and  quality  control  of  products 
and devices for human medicine, dentistry or veterinary medicine – over 45,000 fewer 
than in 2002. 

Approximately 40% of animals used received some form of anaesthesia. For the other 
animals the use of anaesthesia would have been deemed to increase the severity of the 
procedure. 

As in 2002 no animals were used to evaluate the safety of either cosmetic products or 
cosmetic ingredients. 

No animals were used in 2005 for monoclonal antibody production using the ascites 
method.

EN 

127 

   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 

1 048 052 
408 104 
28 918 
2 219 

15 063 
205 
4 294 
970 

- 
501 
135 
- 

140 

690 
1 183 
- 
1 256 

410 
103 
194 
- 

- 
108 
6 
- 

- 

40 
- 
- 
271 

2 
- 
- 
- 

- 
34 
- 
- 

- 

3 282 
2 214 
- 
- 

48 
- 
885 
34 

- 
- 
2 331 
- 

- 

2 315  
175  
907  
18  

-  
148  
590  
-  

1 052 064 
411 501 
28 918 
3 746 
8 216 
15 523 
308 
5 373 
1 004 
938 
308 
4 127 
274 
11 772 
6 306 
- 
643 
2 472 
- 
2 541 
140 
114 860 
84 
10 585 
192 504 
1 874 207 

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 

128 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EN 

129 

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. 

55 660  
115 092  
3 235  
1 656  
5 266  
1 488  
237  
119  
172  
502  
38  

2 046  
233  
5 681  
4 312  
-  
114  
89  
-  
1 937  
140  
29 119  
 70  
8 943  
106 445  

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) 

92 488 
143 212 
11 578 
30 
2 794 
768 
71 
748 
94 
- 
31 

445 
6 
136 
523 
- 
86 
110 
- 
- 
- 
687 
- 
- 
2 275 

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

81 113 
110 005 
2 890 
1 304 
 40 
8 456 
- 
4 248 
- 
- 
25 

541 
3 
 223 
 345 
- 
334 
2 257 
- 
15 
- 
4 000 
 12 
- 
32 799 

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 

63 461 
4 061 
7 396 
60 
- 
338 
- 
4 
6 
- 
- 

36 
- 
- 
- 
- 
8 
- 
- 
- 
- 
- 
- 
- 
- 

18 280 
- 
1 273 
480 
 - 
990 
- 
- 
- 
- 
50 

716 
- 
 169 
 718 
- 
- 
- 
- 
- 
- 
5 746 
- 
- 
6 592 

130 

2.7 
Diagnosis of 
disease 

2.8 
Education and 
training 

2.9 
Other 

2.10 
Total 

8 016 
10 
448 
- 
- 
1 737 
- 
15 
35 
- 
68 

- 
11 
408 
9 
- 
16 

- 
- 
 - 
2 470 
 - 
 - 
163 

896 
1 427 
118 
- 
2 
32 
- 
- 
13 
- 
8 

- 
- 
5 
- 
- 
- 
- 
- 
- 
- 
6 
- 
- 
- 

432 150 
37 694 
1 980 
216 
114 
1 714 
- 
39 
684 
436 
88 

343 
21 
5 150 
399 
- 
85 
16 
- 
589 
- 
72 832 
2 
1 642 
44 230 

1 052 064  
411 501  
28 918  
3 746  
8 216  
15 523  
 308  
5 373  
1 004  
938  
308  

4 127  
274  
11 772  
6 306  
-  
643  
2 472  
-  
2 541  
140  
114 860  
84  
10 585  
192 504  

EN 

 
  
 
2.z. 

TOTAL 

642 594  

256 082 

75 370 

35 014 

248 610 

13 406 

2 507 

600624 

1 874 207  

EN 

131 

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. 

49965 
70890 
2366 
721 
- 
5378 
- 
4012 
- 
- 
25 
409 
- 
213 
297 
- 
297 
1961 
- 
15 
- 
1240 
- 
- 
3326 
141115 

3335 
18134 
120 
551 
40 
1120 
- 
91 
- 
- 
- 
90 
3 
10 
48 
- 
- 
- 
- 
- 
- 
2620 
- 
- 
6579 
32741 

6955 
10621 
128 
16 
- 
1742 
- 
3 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
4398 
23863 

21 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
21 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 

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 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 

3.11 
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 
324 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
131 
- 
- 
16109 
16567 

20834 
10036 
276 
16 
- 
216 
- 
142 
- 
- 
- 
42 
- 
- 
- 
- 
37 
296 
- 
- 
- 
9 
12 
- 
2387 
34303 

81113 
110005 
2890 
1304 
40 
8456 
- 
4248 
- 
- 
25 
541 
3 
223 
345 
- 
334 
2257 
- 
15 
- 
4000 
12 
- 
32799 
248610 

EN 

132 

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. 

22260 
16176 
975 
- 
38 
1005 
- 
466 
102 
2 
- 
278 
31 
116 
135 
- 
33 
41 
- 
240 
- 
1377 
- 
472 
- 
43747 

99729 
145474 
1884 
740 
4517 
99 
98 
3 
140 
- 
12 
62 
- 
474 
1788 
- 
50 
76 
- 
182 
140 
5456 
70 
53 
3282 
264329 

86802 
5694 
- 
76 
85 
63 
- 
10 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
745 
- 
93475 

459327 
187929 
23963 
1707 
3470 
9944 
139 
4502 
749 
500 
94 
2205 
232 
6244 
2398 
- 
547 
2097 
- 
1697 
- 
25010 
12 
7673 
105746 
846185 

22392 
1464 
1564 
639 
- 
1337 
71 
280 
- 
403 
192 
1543 
8 
4864 
1914 
- 
- 
- 
- 
15 
- 
80509 
- 
- 
25538 
142733 

690510 
356737 
28386 
3162 
8110 
12448 
308 
5261 
991 
905 
298 
4088 
271 
11698 
6235 
- 
630 
2214 
- 
2134 
140 
112352 
82 
8943 
134566 
1390469 

EN 

133 

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. 
Pigs 
5.l. 
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: 

Footnotes: 

EN 

1924 
- 
5711 
- 
- 
116 
- 
- 
- 
- 
- 
24 
- 
- 
49 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
7824 

6000 
1920 
1399 
480 
- 
- 
- 
- 
- 
- 
- 
716 
- 
98 
265 
- 
- 
- 
- 
- 
- 
68 
- 
- 
2621 
13567 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 

7107 
1574 
300 
60 
- 
10 
- 
4 
6 
- 
- 
12 
- 
- 
52 
- 
8 
- 
- 
- 
- 
493 
- 
- 
- 
9626 
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. 

66574 
567 
1137 
- 
- 
1202 
- 
- 
- 
- 
50 
- 
- 
71 
352 
- 
- 
- 
- 
- 
- 
5185 
- 
- 
3971 
79109 

136 
- 
122 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
258 

81741 
4061 
8669 
540 
- 
1328 
- 
4 
6 
- 
50 
752 
- 
169 
718 
- 
8 
- 
- 
- 
- 
5746 
- 
- 
6592 
110384 

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 Hungarian requirement 
5.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 

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: 

134 

EN 

 
  
 
 
 
 
 
 
 
2)  Member  Countries  of  Council  of  Europe  (non-EC):  Albania,  Andorra,  Bulgaria,  Croatia,  Cyprus,  Czech  Rep.,  Estonia,  Hungary,  Iceland,  Latvia,  Liechtenstein,  Lithuania, 

Malta, Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

EN 

135 

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. 
6.z. 
TOTAL 
Examples: 

566 
1000 
4 
- 
- 
29 
- 
- 
- 
- 
- 
- 
- 
- 
4 
- 
- 
- 
- 
- 
- 
50 
12 
- 
3581 
5246 

8683 
3862 
165 
- 
- 
2114 
- 
24 
- 
- 
- 
181 
- 
36 
151 
- 
- 
- 
- 
15 
- 
950 
- 
- 
7148 
23329 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 

12939 
8985 
389 
282 
40 
112 
- 
173 
- 
- 
- 
55 
- 
6 
12 
- 
37 
50 
- 
- 
- 
172 
- 
- 
5816 
29068 
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. 

57004 
92289 
2076 
1022 
- 
5662 
- 
4051 
- 
- 
25 
305 
3 
181 
178 
- 
297 
2207 
- 
- 
- 
2306 
- 
- 
15110 
182716 

1921 
3869 
256 
- 
- 
539 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
522 
- 
- 
1144 
8251 

81113 
110005 
2890 
1304 
40 
8456 
- 
4248 
- 
- 
25 
541 
3 
223 
345 
- 
334 
2257 
- 
15 
- 
4000 
12 
- 
32799 
248610 

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 Hungarian requirement 
6.5 – Sweden 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, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom 
2)  Member Countries of Council of Europe (non-EC): Albania, Andorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, Malta, 

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: 

Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine 

136 

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 

7.2.1. 
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. 

6784 
3636 
217 
- 
- 
- 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
920 
- 
- 
9192 
20749 

384 
2309 
- 
- 
- 
12 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
13 
- 
- 
- 
- 
140 
- 
- 
7157 
10015 

7497 
30789 
86 
482 
- 
532 
- 
2279 
- 
- 
- 

52 
- 
24 
39 
- 
112 
1035 
- 
- 
- 
400 
- 
- 
6963 
50290 

6 
- 
12 
- 
- 
1302 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
1320 

EN 

- 
- 
- 
- 
- 
837 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
837 

4424 
11778 
- 
- 
- 
244 
- 
1541 
- 
- 
- 

- 
- 
- 
- 
- 
155 
838 
- 
- 
- 
- 
- 
- 
752 
19732 

7549 
8654 
- 
- 
- 
- 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
16203 

769 
4556 
- 
- 
- 
3141 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
8466 

3247 
5565 
- 
- 
- 
- 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
226 
9038 

- 
25216 
- 
- 
- 
123 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
710 
26049 

2496 
- 
278 
- 
- 
- 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
2774 

137 

7.12 
Other 

7.13 
Total 

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

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 

47957 
17502 
2297 
822 
40 
2265 
- 
428 
- 
- 
25 

489 
3 
199 
306 
- 
54 
384 
- 
15 
- 
2540 
12 
- 
7799 
83137 

81113 
110005 
2890 
1304 
40 
8456 
- 
4248 
- 
- 
25 

541 
3 
223 
345 
- 
334 
2257 
- 
15 
- 
4000 
12 
- 
32799 
248610 

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.a. 

8.b. 

8.c. 

8.d. 

8.e. 

8.f. 

8.g. 

8.h. 

for 
Products/substances  or  devices 
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 

8.2.1. 
LD50, 
LC50 

8.2.2 
Other lethal 
methods 

8.2.3 
Non lethal 
clinical signs 
methods 

- 

383 

32535 

103 

428 

18 

16045 

14662 

7260 

5558 

14797 

- 

49326 

141115 

3213 

2703 

7461 

2288 

1824 

7050 

280 

937 

365 

240 

2214 

1377 

832 

839 

7915 

1775 

579 

577 

60 

264 

1720 

2357 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

4268 

3927 

2504 

10980 

1178 

740 

- 

- 

- 

- 

- 

- 

21 

- 

- 

- 

- 

185 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

226 

980 

896 

104 

110 

695 

- 

20749 

10015 

50290 

1320 

2774 

837 

19732 

16203 

8466 

9038 

26049 

138 

- 

- 

- 

- 

- 

- 

- 

- 

- 

5302 

32741 

4432 

23863 

- 

- 

- 

- 

21 

- 

- 

- 

4662 

16567 

19415 

34303 

83137 

248610 

EN