EN    EN  COMMISSION OF THE E UROPEAN 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 Nu mber of Animals used for Experimental and 
other Scientific Purposes in the Member States of the European Union 
 
 
{COM (2007) 675 final}
 
EN 2   EN Important notice 
This Report is a document of the Commission serv ices and cannot be considered binding to 
this institution in any way.
 
EN 3   EN PART B II: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE 
MEMBER STATES 
 
EN 4   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 5   EN ITALY  
Statistical data submitted 
The statistical data have been submitted by the Ministry of Health  – Department for public veterinary 
health food and animal safety, Direct orate-General for animal health a nd 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, den tistry and veterinary medicine. 
 15.38% of the animals were used in the production and quality control of products and 
devices for human medicine, dentis try 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% of the animals were used to study human diseases, while 1.33%  were used to 
study animal diseases. 
Article 24 of Directive 86/609/EEC has allowed tight er 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 inves tigations of diseases affecting cats themselves. Since 
2003 no animals have been used to test finished cosmetic products. 
Signed:Prof. Sergio Papalia  
Director, Office  
 
EN 6   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 534614 516400 6073 97 12044  
1.b. Rats ( Rattus norvegicus ) 279774 276681 2758 4 331  
1.c. Guinea-Pigs ( Cavia porcellus ) 11533 6879 4613 15 26  
1.d. Hamsters ( Mesocricetus ) 1537 1473 0 0 64  
1.e. Other Rodents (other Rodentia ) 2303   0 0  
1.f. Rabbits ( Oryctolagus cuniculus ) 9916 9842 74 0 0 351 
1.g. Cats ( Felis catus ) 30 0 30 0 0 0 
1.h. Dogs ( Canis familiaris ) 1064 601 0 93 370 68 
1.i. Ferrets ( Mustela putorius furo ) 0 0 0 0 0 0 
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 63      
1.l. Pigs ( Sus) 2579      
1.m. Goats ( Capra ) 20      
1.n. Sheep ( Ovis)  584      
1.o. Cattle ( Bos) 1174      
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 17 12 5 0 0 87 
1.r. Old World Monkeys ( Cercopithecoidea ) 395 7 343 3 42 85 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 68    0 0 
1.u. Quail ( Coturnix coturnix)  0 0 0 0 0 0 
1.v. Other birds (other Aves ) 31697      
1.w. Reptiles ( Reptilia ) 378      
1.x. Amphibians ( Amphibia ) 4636      
1.y. Fish ( Pisces ) 14584      
1.z. TOTAL 896966      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 7   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 292138 146808 26561 4744 34518 24245 403 5197 534614 
2.b. Rats 79546 83690 81993 170 30818 1115 317 2125 279774 
2.c. Guinea-Pigs 1778 4040 3740 451 1444 53 15 12 11533 
2.d. Hamsters 1092 76 0 0 57 312 0 0 1537 
2.e. Other Rodents 400 1043 0 0 0 860 0 0 2303 
2.f. Rabbits 1766 1228 4195 855 1626 38 0 208 9916 
2.g. Cats 0 30 0 0 0 0 0 0 30 
2.h. Dogs 12 59 0 0 993 0 0 0 1064 
2.i. Ferrets 0 0 0 0 0 0 0 0 0 
2.j. Other Carnivores 0 0 0 0 0 0 0 0 0 
2.k. Horses, donkeys and cross 
breds 34 3 24 0 0 0 0 2 63 
2.l. Pigs 758 405 18 71 333 0 249 745 2579 
2.m. Goats 13 4 0 0 0 1 0 2 20 
2.n. Sheep 187 257 51 75 14 0 0 0 584 
2.o. Cattle 1024 62 1 73 0 10 0 4 1174 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 9 8 0 0 0 0 0 0 17 
2.r. Old World Monkeys 20 11 37 0 327 0 0 0 395 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 58 0 0 10 0 0 0 0 68 
2.u. Quail 0 0 0 0 0 0 0 0 0 
2.v. Other birds 6915 2519 15 14621 6102 3 0 1522 31697 
2.w. Reptiles 348 0 0 0 0 0 0 30 378 
2.x. Amphibians 4495 30 0 0 42 69 0 0 4636 
2.y. Fish 4820 5674 0 310 3520 0 0 260 14584 
2.z. TOTAL 395413 245947 116635 21380 79794 26706 984 10107 896966 
 
EN 8   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual 
contaminants in 
the general 
environment 
which do not 
appear in other 
columns 3.10 
Other toxico-
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 12523 69 290 0 0 390 182 2782 18282 34518 
3.b. Rats 20550 288 2424 0 0 766 0 4830 1960 30818 
3.c. Guinea-Pigs 959 70 397 0 0 0 0 0 18 1444 
3.d. Hamsters 57 0 0 0 0 0 0 0 0 57 
3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 
3.f. Rabbits 1479 0 129 0 0 0 0 0 18 1626 
3.g. Cats 0 0 0 0 0 0 0 0 0 0 
3.h. Dogs 929 0 64 0 0 0 0 0 0 993 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 313 0 0 0 0 0 0 0 20 333 
3.m. Goats 0 0 0 0 0 0 0 0 0 0 
3.n. Sheep 12 0 0 0 0 0 0 0 2 14 
3.o. Cattle 0 0 0 0 0 0 0 0 0 0 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.r. Old World Monkeys 327 0 0 0 0 0 0 0 0 327 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 0 0 0 0 0 0 0 0 0 
3.v. Other birds 6082 0 0 0 0 0 0 0 20 6102 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 42 42 
3.y. Fish 255 0 0 0 0 0 0 3265 0 3520 
3.z. TOTAL 43486 427 3304 0 0 1156 182 10877 20362 79794 
 
EN 9   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 13061 61492 113322 132766 4449 325090 
4.b. Rats 7290 49905 9863 37583 196 104837 
4.c. Guinea-Pigs 632 966 0 2891 189 4678 
4.d. Hamsters 100 659 144 12 6 921 
4.e. Other Rodents 0 986 0 196 727 1909 
4.f. Rabbits 378 195 19 1030 120 1742 
4.g. Cats 0 0 0 0 30 30 
4.h. Dogs 6 141 268 49 6 470 
4.i. Ferrets 0 0 0 0 0 0 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 0 0 0 0 
4.l. Pigs 165 2 0 103 25 295 
4.m. Goats 0 0 0 0 0 0 
4.n. Sheep 11 0 40 18 32 101 
4.o. Cattle 0 0 0 7 0 7 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 0 12 0 0 0 12 
4.r. Old World Monkeys 0 3 125 6 0 134 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 0 0 0 0 0 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 0 0 0 22 70 92 
4.w. Reptiles 0 0 0 0 0 0 
4.x. Amphibians 0 131 0 451 0 582 
4.y. Fish 0 0 221 0 0 221 
4.z. TOTAL 21643 114492 124002 175134 5850 441121 
 
EN 10   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 4176 7816 0 40 15405 3868 31305 
5.b. Rats 425 1789 0 0 78237 1712 82163 
5.c. Guinea-Pigs 1326 29 0 0 2630 206 4191 
5.d. Hamsters 0 0 0 0 0 0 0 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 1112 3297 0 0 460 181 5050 
5.g. Cats 0 0 0 0 0 0 0 
5.h. Dogs 0 0 0 0 0 0 0 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 24 0 0 0 0 0 24 
5.l. Pigs 50 39 0 0 0 0 89 
5.m. Goats 0 0 0 0 0 0 0 
5.n. Sheep 119 7 0 0 0 0 126 
5.o. Cattle 57 17 0 0 0 0 74 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 37 0 37 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 10 0 0 0 0 0 10 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 1607 13029 0 0 0 0 14636 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 310 310 
5.z. TOTAL 8906 26023 0 40 96769 6277 138015 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 11   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 23592 6728 0 390 3259 549 34518 
6.b. Rats 8821 8374 0 941 12359 323 30818 
6.c. Guinea-Pigs 199 491 0 0 754 0 1444 
6.d. Hamsters 0 48 0 0 9 0 57 
6.e. Other Rodents 0 0 0 0 0 0 0 
6.f. Rabbits 110 555 0 0 874 87 1626 
6.g. Cats 0 0 0 0 0 0 0 
6.h. Dogs 137 272 0 0 584 0 993 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 20 313 0 0 0 0 333 
6.m. Goats 0 0 0 0 0 0 0 
6.n. Sheep 2 12 0 0 0 0 14 
6.o. Cattle 0 0 0 0 0 0 0 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 0 0 0 
6.r. Old World Monkeys 0 0 0 0 327 0 327 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 0 0 0 0 0 0 
6.v. Other birds 4840 1262 0 0 0 0 6102 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 42 0 0 0 0 0 42 
6.y. Fish 3450 0 0 0 0 70 3520 
6.z. TOTAL 41213 18055 0 1331 18166 1029 79794 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 12   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino-
genicity 7.8 
Develop-
mental 
toxicity 7.9 
Muta-
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 1201 11332 6873 234 71 0 1298 3596 155 589 389 0 8780 34518 
7.b. Rats 667 960 8144 0 0 0 7813 4807 1619 420 1352 0 5036 30818 
7.c. Guinea-Pigs 0 0 37 97 1222 0 84 0 0 0 0 0 4 1444 
7.d. Hamsters 0 0 48 0 0 0 0 0 0 0 0 0 9 57 
7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.f. Rabbits 0 0 400 147 5 38 64 0 514 0 264 0 194 1626 
7.g. Cats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.h. Dogs 0 4 285 0 0 0 657 0 0 0 0 0 47 993 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 0 134 0 0 0 92 0 0 0 0 0 107 333 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.n. Sheep 0 0 2 0 0 0 0 0 0 0 0 0 12 14 
7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.r. Old World Monkeys 0 1 93 0 0 0 158 0 0 0 0 0 75 327 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.v. Other birds 0 0 4840 1000 0 0 0 0 0 0 0 0 262 6102 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 42 0 0 0 0 42 
7.y. Fish 2035 0 170 0 0 0 1100 0 0 0 0 215 0 3520 
7.z. TOTAL 3903 12297 21026 1478 1298 38 11266 8403 2330 1009 2005 215 14526 79794 
 
EN 13   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta-
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 1317 1673 16992 1444 759 29 9240 1433 1519 712 1688 185 6495 43486 
8.b. Products/substances used or intended to 
be used mainly in agriculture 0 0 40 0 70 0 0 0 0 0 317 0 0 427 
8.c. Products/substances used or intended to 
be used mainly in industry 0 58 1053 34 468 9 466 0 769 297 0 0 150 3304 
8.d. Products/substances used or intended to 
be used mainly in the household 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 0 0 1006 0 0 0 150 0 0 0 0 0 0 1156 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 0 182 0 0 0 0 0 0 0 0 0 0 0 182 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 2035 400 128 0 0 0 1100 6970 0 0 0 30 214 10877 
8.i. Other toxicological or safety 
evaluations 551 9984 1807 0 1 0 310 0 42 0 0 0 7667 20362 
8.j. TOTAL 3903 12297 21026 1478 1298 38 11266 8403 2330 1009 2005 215 14526 79794 
 
EN 14   ENLATVIA 
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 15   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 10480 10480     
1.b. Rats ( Rattus norvegicus ) 2376 2376     
1.c. Guinea-Pigs ( Cavia porcellus ) 297 297     
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia )       
1.f. Rabbits ( Oryctolagus cuniculus ) 166 166     
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 0      
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora )       
1.k. Horses, donkeys and cross breds ( Equidae )       
1.l. Pigs ( Sus)       
1.m. Goats ( Capra )       
1.n. Sheep ( Ovis)        
1.o. Cattle ( Bos)       
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia )       
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves )       
1.w. Reptiles ( Reptilia )       
1.x. Amphibians ( Amphibia )       
1.y. Fish ( Pisces )       
1.z. TOTAL 13319 13319     
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, 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 b oxes need to be completed.  
Note 3:  The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
 
EN 16   EN TABLE 2: NUMBER OF ANIMALS USED IN  EXPERIMENTS FOR SELECTED PURPOSES  
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 2352 3068 2800   1494 766  10480 
2.b. Rats 265 1105 613  90 126 177  2376 
2.c. Guinea-Pigs 57     240   297 
2.d. Hamsters         0 
2.e. Other Rodents         0 
2.f. Rabbits 121     45   166 
2.g. Cats         0 
2.h. Dogs         0 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds         0 
2.l. Pigs         0 
2.m. Goats         0 
2.n. Sheep         0 
2.o. Cattle         0 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals         0 
2.u. Quail         0 
2.v. Other birds         0 
2.w. Reptiles         0 
2.x. Amphibians         0 
2.y. Fish         0 
 
EN 17   EN 2.z. TOTAL 2795 4173 3413 0 90 1905 943 0 13319 
 
EN 18   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami-
nants in the 
general envi-
ronment which 
do not appear in 
other columns 3.10 
Other toxico-
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice          0  
3.b. Rats         90 90 
3.c. Guinea-Pigs          0  
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits          0  
3.g. Cats          0  
3.h. Dogs          0  
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle          0  
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail          0  
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish          0  
3.z. TOTAL 0 0 0 0 0 0 0 0 90 90 
 
EN 19   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice      0 
4.b. Rats      0 
4.c. Guinea-Pigs      0 
4.d. Hamsters      0 
4.e. Other Rodents      0 
4.f. Rabbits      0 
4.g. Cats      0 
4.h. Dogs      0 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs      0 
4.m. Goats      0 
4.n. Sheep      0 
4.o. Cattle      0 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail      0 
4.v. Other birds      0 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish      0 
4.z. TOTAL 0 0 0 0 0 0 
 
EN 20   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     2800  2800 
5.b. Rats     613  613 
5.c. Guinea-Pigs       0  
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits       0  
5.g. Cats       0  
5.h. Dogs       0  
5.i. Ferrets       0  
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds       0  
5.l. Pigs       0  
5.m. Goats       0  
5.n. Sheep       0  
5.o. Cattle       0  
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds       0  
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 0 0 0 0 3413 0 3413 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 21   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 22   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Regulatory requirements versus species 
6.1 
Species 6.2  
National legislation 
specific to a single EC 
Member State 
1) 6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 6.5 
Other legislation 6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 6.7 
No regulatory 
requirements 6.8 
Total 
6.a. Mice       0  
6.b. Rats      90 90 
6.c. Guinea-Pigs       0  
6.d. Hamsters       0  
6.e. Other Rodents       0  
6.f. Rabbits       0  
6.g. Cats       0  
6.h. Dogs       0  
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats       0  
6.n. Sheep       0  
6.o. Cattle       0  
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail       0  
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish       0  
6.z. TOTAL 0 0 0 0 0 90 90 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 23   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino- 
genicity 7.8 
Develop-
mental 
toxicity 7.9 
Muta-
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice              0  
7.b. Rats           90   90 
7.c. Guinea-Pigs              0  
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits              0  
7.g. Cats              0  
7.h. Dogs              0  
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep              0  
7.o. Cattle              0  
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail              0  
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish              0  
7.z. TOTAL 0 0 0 0 0 0 0 0 0 0 90 0 0 90 
 
EN 24   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine           90   90 
8.b. Products/substances used or intended to 
be used mainly in agriculture              0  
8.c. Products/substances used or intended to 
be used mainly in industry              0  
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption              0  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns              0  
8.i. Other toxicological or safety 
evaluations              0  
8.j. TOTAL 0 0 0 0 0 0 0 0 0 0 90 0 0 90 
 
EN 25   ENLITHUANIA 
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 26   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 5116 5116     
1.b. Rats ( Rattus norvegicus ) 493 493     
1.c. Guinea-Pigs ( Cavia porcellus ) 0      
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia )       
1.f. Rabbits ( Oryctolagus cuniculus ) 158 158     
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 0      
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora )       
1.k. Horses, donkeys and cross breds ( Equidae )       
1.l. Pigs ( Sus)       
1.m. Goats ( Capra )       
1.n. Sheep ( Ovis)        
1.o. Cattle ( Bos)       
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia )       
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves )       
1.w. Reptiles ( Reptilia )       
1.x. Amphibians ( Amphibia )       
1.y. Fish ( Pisces )       
1.z. TOTAL 5767      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 27   EN TABLE 2: NUMBER OF ANIMALS USED IN  EXPERIMENTS FOR SELECTED PURPOSES  
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 1773    330 2583 430  5116 
2.b. Rats 323    120  50  493 
2.c. Guinea-Pigs         0 
2.d. Hamsters         0 
2.e. Other Rodents         0 
2.f. Rabbits 96    62    158 
2.g. Cats         0 
2.h. Dogs         0 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds         0 
2.l. Pigs         0 
2.m. Goats         0 
2.n. Sheep         0 
2.o. Cattle         0 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals         0 
2.u. Quail         0 
2.v. Other birds         0 
2.w. Reptiles         0 
2.x. Amphibians         0 
2.y. Fish         0 
 
EN 28   EN 2.z. TOTAL 2192 0 0 0 512 2583 480 0 5767 
 
EN 29   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami-
nants in the 
general envi-
ronment which 
do not appear in 
other columns 3.10 
Other toxico-
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice  330        330 
3.b. Rats  120        120 
3.c. Guinea-Pigs          0  
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits 62         62 
3.g. Cats          0  
3.h. Dogs          0  
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle          0  
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail          0  
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish          0  
3.z. TOTAL 62 450 0 0 0 0 0 0 0 512 
 
EN 30   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice    2583  2583 
4.b. Rats      0 
4.c. Guinea-Pigs      0 
4.d. Hamsters      0 
4.e. Other Rodents      0 
4.f. Rabbits      0 
4.g. Cats      0 
4.h. Dogs      0 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs      0 
4.m. Goats      0 
4.n. Sheep      0 
4.o. Cattle      0 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail      0 
4.v. Other birds      0 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish      0 
4.z. TOTAL 0 0 0 2583 0 2583 
 
EN 31   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION  AND QUALITY CONTROL OF  PRODUCTS AND DEVICES FOR 
HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 
Regulatory requirements versus species 
5.1 
Species 5.2  
National legislation 
specific to a single EC 
Member State 
1) 5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 5.5 
Other legislation 5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 5.7 
No regulatory 
requirements 5.8 
Total 
5.a. Mice       0  
5.b. Rats       0  
5.c. Guinea-Pigs       0  
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits       0  
5.g. Cats       0  
5.h. Dogs       0  
5.i. Ferrets       0  
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds       0  
5.l. Pigs       0  
5.m. Goats       0  
5.n. Sheep       0  
5.o. Cattle       0  
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds       0  
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 0 0 0 0 0 0 0 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 32   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 33   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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  330     330 
6.b. Rats  120     120 
6.c. Guinea-Pigs       0  
6.d. Hamsters       0  
6.e. Other Rodents       0  
6.f. Rabbits  62     62 
6.g. Cats       0  
6.h. Dogs       0  
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats       0  
6.n. Sheep       0  
6.o. Cattle       0  
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail       0  
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish       0  
6.z. TOTAL 0 512 0 0 0 0 512 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 34   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino-
genicity 7.8 
Develop-
mental 
toxicity 7.9 
Muta-
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice   100          230 330 
7.b. Rats   60          60 120 
7.c. Guinea-Pigs              0  
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits             62 62 
7.g. Cats              0  
7.h. Dogs              0  
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep              0  
7.o. Cattle              0  
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail              0  
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish              0  
7.z. TOTAL 0 0 160 0 0 0 0 0 0 0 0 0 352 512 
 
EN 35   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine             62 62 
8.b. Products/substances used or intended to 
be used mainly in agriculture   160          290 450 
8.c. Products/substances used or intended to 
be used mainly in industry              0  
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption              0  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns              0  
8.i. Other toxicological or safety 
evaluations              0  
8.j. TOTAL 0 0 160 0 0 0 0 0 0 0 0 0 352 512 
 
EN 36   ENLUXEMBOURG  
Statistical data submitted 
The statistical data have been submitted by the “ Ministère de l’Ag riculture, 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 register ed 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 welf are lies with a veterinary inspector, who 
carries out at least 2 inspections per y ear 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 a nd the antigenicity of antigens 
to improve vaccination strategies and dia gnostic procedures for specific diseases; 
b) projects relating to i mmunology and immunodeficiency. 
Director of the Veterinary Services Administration Dr Arthur Besch 
Remark: 
Please note that only relevant EU tables containing data ar e included in this report. No 
uses of animals were re ported in Tables 3-8. 
 
EN 37   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 3280 3280     
1.b. Rats ( Rattus norvegicus ) 720 720     
1.c. Guinea-Pigs ( Cavia porcellus ) 100 100     
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia )       
1.f. Rabbits ( Oryctolagus cuniculus ) 20 20     
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 0      
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora )       
1.k. Horses, donkeys and cross breds ( Equidae )       
1.l. Pigs ( Sus)       
1.m. Goats ( Capra )       
1.n. Sheep ( Ovis)        
1.o. Cattle ( Bos)       
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia )       
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves )       
1.w. Reptiles ( Reptilia )       
1.x. Amphibians ( Amphibia )       
1.y. Fish ( Pisces )       
1.z. TOTAL 4120 4120     
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 38   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 280 3000       3280 
2.b. Rats 320 400       720 
2.c. Guinea-Pigs  100       100 
2.d. Hamsters         0 
2.e. Other Rodents         0 
2.f. Rabbits  20       20 
2.g. Cats         0 
2.h. Dogs         0 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds         0 
2.l. Pigs         0 
2.m. Goats         0 
2.n. Sheep         0 
2.o. Cattle         0 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals         0 
2.u. Quail         0 
2.v. Other birds         0 
2.w. Reptiles         0 
2.x. Amphibians         0 
2.y. Fish         0 
 
EN 39   EN 2.z. TOTAL 600 3520 0 0 0 0 0 0 4120 
 
EN 40   EN MALTA 
No animals were used in Malta in 2005 for experimental or other scientific purposes. 
 
EN 41   EN THE NETHERLANDS  
Statistical data submitted 
The statistical data have been submitted by the “ Keuringsdienst van Wa ren, Ministerie voor 
Volksgezondheid, Welzijn en Sport ” (Inspectorate for Goods, Mi nistry 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 pub lished annually including the ei ght 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 Du tch EU-contribution. The nu mbers in the national 
statistics are higher due to the following: 
1. In addition to the EU statistics, killing an imals solely for harvesting tissues or organs 
is considered to be an experiment and contribut es 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 connect ed with the experiment performed on them 
before their death. 
2. Furthermore the Dutch statistics are base d on the number of experiments performed 
and not so much on the number of animals involv ed. 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 anim als were not included in  the EU statistics. 
The national statistics include 19 tables relating species to differe nt topics. Like e.g. origin of 
the animal, type of experiment, severity sc ore, mandatory testing, anaesthesia, pain 
alleviation, etc. Furthermore 14 ta bles on type of experiment ve rsus species and their origin, 
safety testing and special techniques, etc are publ ished. Special tables ar e 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 pro cedure of ethical reviewing prior to the start 
of the experiment. Part of the ethical review ing is assessing by the responsible researcher, 
proposed expected severity score. During the ex periment the animals are closely watched also 
to assess the actually experienced  discomfort, harm, distress, et c. The experienced severity 
score is the one that is registered. Th e Dutch law recognises 6 severity bands:  
- minor (35.5% of the experiments in 2005) 
 
EN 42   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 wo rld 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 an imal 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 th e 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 c onducted a total of 554 
inspections in 2005 of which approximate ly 40% was unannounced beforehand. These 
inspections clearly showed that th e 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 th e 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 afte r the notified deadline. These infringements 
consisted of: 
- housing of animals; - entering remarks in a so-called welfare diary (whi ch has to be present at  the animal room to 
be used for recording all relevant welfare remarks); 
- handling of and caring for the an imals by not yet licensed personnel; 
- conducting experiments on anim als 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 43   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 rest rictions on transport of an imals 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 situ ation 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 an imal experiments. Potentially harming effects 
of substances covered 5.1%, diagnostic pro cedures 1.4% and educat ion and training 2.0%. 
(These percentages are all based on the nationa l statistics, hence incl uding re-use and organ 
harvesting.) 
Licence holding establishments A licence to perform animal experiments is oblig ed in order to perform any experiment. In 
2005 a total of 80 licence-holding establishmen ts were registered by VWA. Three new 
licences were issued and one licence was term inated on request of the licence-holder.  
In order to be allowed to br eed 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 44   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 240048 228666 0 7733 3649 5695 
1.b. Rats ( Rattus norvegicus ) 116608 111973 0 4423 212 3357 
1.c. Guinea-Pigs ( Cavia porcellus ) 7479 4319 0 3150 10 46 
1.d. Hamsters ( Mesocricetus ) 5322 4961 0 357 4 13 
1.e. Other Rodents (other Rodentia ) 3089 1798 0 1167 124 521 
1.f. Rabbits ( Oryctolagus cuniculus ) 8251 7556 0 665 30 663 
1.g. Cats ( Felis catus ) 334 233 0 30 71 14 
1.h. Dogs ( Canis familiaris ) 1049 528 0 98 423 194 
1.i. Ferrets ( Mustela putorius furo ) 256 21 0 50 185 0 
1.j. Other Carnivores (other Carnivora ) 151 0 0 0 151 0 
1.k. Horses, donkeys and cross breds ( Equidae ) 1705 541 0 0 1164 858 
1.l. Pigs ( Sus) 9853 4113 540 65 5135 63 
1.m. Goats ( Capra ) 328 114 0 0 214 65 
1.n. Sheep ( Ovis)  2667 184 0 10 2473 152 
1.o. Cattle ( Bos) 4410 2602 3 81 1724 429 
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 50 32 0 18 0 5 
1.r. Old World Monkeys ( Cercopithecoidea ) 277 223 0 35 19 185 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 13 0 0 0 13 0 
1.u. Quail ( Coturnix coturnix)  152 0 0 152 0 0 
1.v. Other birds (other Aves ) 111081 15137 26 0 95918 603 
1.w. Reptiles ( Reptilia ) 7 2 0 0 5 0 
1.x. Amphibians ( Amphibia ) 3231 2877 0 7 347 0 
1.y. Fish ( Pisces ) 14838 6906 683 1250 5999 119 
1.z. TOTAL 531199 392786 1252 19291 117870 12982 
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, are Parties to the Convention  ETS 123. Thus an updated list 
of those countries has to be us ed when filling in  this column. 
Note 2: Only the white b oxes need to be completed.  
Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2  
 
EN 45   EN 
 
EN 46   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 143937 47957 14519 16107 6114 8704 2710 0 240048 
2.b. Rats 34904 20931 32029 2769 23100 0 2875 0 116608 
2.c. Guinea-Pigs 609 1553 1223 3621 429 3 41 0 7479 
2.d. Hamsters 811 94 5 4356 45 0 11 0 5322 
2.e. Other Rodents 197 2781 0 0 0 0 111 0 3089 
2.f. Rabbits 751 1211 88 2222 3920 15 44 0 8251 
2.g. Cats 129 33 0 83 6 0 83 0 334 
2.h. Dogs 166 157 0 287 401 0 38 0 1049 
2.i. Ferrets 136 108 0 0 0 0 12 0 256 
2.j. Other Carnivores 151 0 0 0 0 0 0 0 151 
2.k. Horses, donkeys and cross 
breds 2 163 65 1473 0 0 2 0 1705 
2.l. Pigs 5336 2482 82 1725 56 0 172 0 9853 
2.m. Goats 221 43 0 0 0 0 64 0 328 
2.n. Sheep 211 194 2179 74 0 0 9 0 2667 
2.o. Cattle 2930 875 53 322 0 0 230 0 4410 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 13 23 0 0 14 0 0 0 50 
2.r. Old World Monkeys 196 71 10 0 0 0 0 0 277 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 0 13 0 0 0 0 0 0 13 
2.u. Quail 0 0 0 0 152 0 0 0 152 
2.v. Other birds 34618 28022 333 47775 24 3 306 0 111081 
2.w. Reptiles 6 0 0 0 0 0 1 0 7 
2.x. Amphibians 3151 0 0 0 0 0 80 0 3231 
2.y. Fish 7919 739 280 0 5384 0 516 0 14838 
 
EN 47   EN 2.z. TOTAL 236394 107450 50866 80814 39645 8725 7305 0 531199 
 
EN 48   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami-
nants in the 
general envi-
ronment which 
do not appear in 
other columns 3.10 
Other toxico-
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 2819 92 2382 0 0 322 0 247 252 6114 
3.b. Rats 6140 5574 8389 0 0 1558 479 0 960 23100 
3.c. Guinea-Pigs 276 0 131 0 0 19 0 0 3 429 
3.d. Hamsters 45 0 0 0 0 0 0 0 0 45 
3.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 
3.f. Rabbits 2554 885 371 0 0 6 104 0 0 3920 
3.g. Cats 6 0 0 0 0 0 0 0 0 6 
3.h. Dogs 301 100 0 0 0 0 0 0 0 401 
3.i. Ferrets 0 0 0 0 0 0 0 0 0 0 
3.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 
3.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 0 0 0 
3.l. Pigs 0 0 0 0 0 56 0 0 0 56 
3.m. Goats 0 0 0 0 0 0 0 0 0 0 
3.n. Sheep 0 0 0 0 0 0 0 0 0 0 
3.o. Cattle 0 0 0 0 0 0 0 0 0 0 
3.p. Prosimians 0 0 0 0 0 0 0 0 0 0 
3.q. New World Monkeys 14 0 0 0 0 0 0 0 0 14 
3.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 
3.s. Apes 0 0 0 0 0 0 0 0 0 0 
3.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 
3.u. Quail 0 152 0 0 0 0 0 0 0 152 
3.v. Other birds 0 24 0 0 0 0 0 0 0 24 
3.w. Reptiles 0 0 0 0 0 0 0 0 0 0 
3.x. Amphibians 0 0 0 0 0 0 0 0 0 0 
3.y. Fish 0 350 180 0 0 0 0 4854 0 5384 
3.z. TOTAL 12155 7177 11453 0 0 1961 583 5101 1215 39645 
 
EN 49   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 15137 13750 48651 77344 12479 167361 
4.b. Rats 3922 8641 2910 29959 50 45482 
4.c. Guinea-Pigs 0 24 0 1794 145 1963 
4.d. Hamsters 0 19 125 588 76 808 
4.e. Other Rodents 0 0 0 2781 0 2781 
4.f. Rabbits 340 5 28 1181 212 1766 
4.g. Cats 0 1 0 24 69 94 
4.h. Dogs 68 0 0 52 178 298 
4.i. Ferrets 0 0 0 152 71 223 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 0 0 165 165 
4.l. Pigs 277 0 21 511 3673 4482 
4.m. Goats 89 0 0 142 2 233 
4.n. Sheep 13 0 0 162 230 405 
4.o. Cattle 0 0 0 61 1265 1326 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 0 5 0 27 0 32 
4.r. Old World Monkeys 0 0 0 201 0 201 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 0 0 13 0 13 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 0 0 0 482 33870 34352 
4.w. Reptiles 0 0 0 0 1 1 
4.x. Amphibians 0 0 7 0 0 7 
4.y. Fish 0 0 0 271 933 1204 
4.z. TOTAL 19846 22445 51742 115745 53419 263197 
 
EN 50   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS AND DEVICES FOR HUMAN 
MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE 
Regulatory requirements versus species 
5.1 
Species 5.2  
National legislation 
specific to a single EC 
Member State 
1) 5.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 5.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 5.5 
Other legislation 5.6 
Any combination of  
5.2/ 5.3/ 5.4/ 5.5 5.7 
No regulatory 
requirements 5.8 
Total 
5.a. Mice 0 11126 0 1768 14929 2803 30626 
5.b. Rats 0 3650 0 72 30483 593 34798 
5.c. Guinea-Pigs 0 1139 7 0 2234 1464 4844 
5.d. Hamsters 0 0 0 0 4354 7 4361 
5.e. Other Rodents 0 0 0 0 0 0 0 
5.f. Rabbits 0 34 0 0 1996 280 2310 
5.g. Cats 0 13 0 0 52 18 83 
5.h. Dogs 0 0 0 0 149 138 287 
5.i. Ferrets 0 0 0 0 0 0 0 
5.j. Other Carnivores 0 0 0 0 0 0 0 
5.k. Horses, donkeys and cross breds 0 0 0 0 136 1402 1538 
5.l. Pigs 0 127 0 9 1248 423 1807 
5.m. Goats 0 0 0 0 0 0 0 
5.n. Sheep 8 0 0 0 26 2219 2253 
5.o. Cattle 7 0 26 10 161 171 375 
5.p. Prosimians 0 0 0 0 0 0 0 
5.q. New World Monkeys 0 0 0 0 0 0 0 
5.r. Old World Monkeys 0 0 0 0 0 10 10 
5.s. Apes 0 0 0 0 0 0 0 
5.t. Other Mammals 0 0 0 0 0 0 0 
5.u. Quail 0 0 0 0 0 0 0 
5.v. Other birds 40 0 0 0 37024 11044 48108 
5.w. Reptiles 0 0 0 0 0 0 0 
5.x. Amphibians 0 0 0 0 0 0 0 
5.y. Fish 0 0 0 0 0 280 280 
5.z. TOTAL 55 16089 33 1859 92792 20852 131680 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 51   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 52   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Regulatory requirements versus species 
6.1 
Species 6.2  
National legislation 
specific to a single EC 
Member State 
1) 6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 6.5 
Other legislation 6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 6.7 
No regulatory 
requirements 6.8 
Total 
6.a. Mice 0 0 0 84 4125 1905 6114 
6.b. Rats 86 0 0 272 21161 1581 23100 
6.c. Guinea-Pigs 0 0 0 0 400 29 429 
6.d. Hamsters 0 0 0 0 45 0 45 
6.e. Other Rodents 0 0 0 0 0 0 0 
6.f. Rabbits 0 0 0 0 3914 6 3920 
6.g. Cats 0 0 0 6 0 0 6 
6.h. Dogs 0 0 0 0 401 0 401 
6.i. Ferrets 0 0 0 0 0 0 0 
6.j. Other Carnivores 0 0 0 0 0 0 0 
6.k. Horses, donkeys and cross breds 0 0 0 0 0 0 0 
6.l. Pigs 0 0 0 0 56 0 56 
6.m. Goats 0 0 0 0 0 0 0 
6.n. Sheep 0 0 0 0 0 0 0 
6.o. Cattle 0 0 0 0 0 0 0 
6.p. Prosimians 0 0 0 0 0 0 0 
6.q. New World Monkeys 0 0 0 0 0 14 14 
6.r. Old World Monkeys 0 0 0 0 0 0 0 
6.s. Apes 0 0 0 0 0 0 0 
6.t. Other Mammals 0 0 0 0 0 0 0 
6.u. Quail 0 0 0 0 152 0 152 
6.v. Other birds 0 0 0 0 0 24 24 
6.w. Reptiles 0 0 0 0 0 0 0 
6.x. Amphibians 0 0 0 0 0 0 0 
6.y. Fish 321 0 0 0 3830 1233 5384 
6.z. TOTAL 407 0 0 362 34084 4792 39645 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 53   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino-
genicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta-
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 0 10 839 0 2077 0 134 236 0 2435 0 0 383 6114 
7.b. Rats 0 1009 3818 611 0 0 3242 0 6661 471 4852 0 2436 23100 
7.c. Guinea-Pigs 0 0 18 0 290 0 23 0 0 0 0 0 98 429 
7.d. Hamsters 0 0 45 0 0 0 0 0 0 0 0 0 0 45 
7.e. Other Rodents 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.f. Rabbits 0 0 140 330 0 167 24 0 60 0 1719 0 1480 3920 
7.g. Cats 0 0 6 0 0 0 0 0 0 0 0 0 0 6 
7.h. Dogs 0 0 169 0 0 0 224 0 0 0 0 0 8 401 
7.i. Ferrets 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.j. Other Carnivores 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.k. Horses, donkeys and cross 
breds 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.l. Pigs 0 0 0 0 0 0 56 0 0 0 0 0 0 56 
7.m. Goats 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.n. Sheep 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.o. Cattle 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.p. Prosimians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.q. New World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 14 14 
7.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.s. Apes 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.t. Other Mammals 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.u. Quail 152 0 0 0 0 0 0 0 0 0 0 0 0 152 
7.v. Other birds 0 0 0 0 0 0 0 0 0 0 0 0 24 24 
7.w. Reptiles 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.x. Amphibians 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
7.y. Fish 1278 535 1713 0 0 0 790 0 804 0 0 264 0 5384 
7.z. TOTAL 1430 1554 6748 941 2367 167 4493 236 7525 2906 6571 264 4443 39645 
 
EN 54   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta-
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 0 119 3200 228 419 6 1469 0 1275 1600 961 0 2878 12155 
8.b. Products/substances used or intended to 
be used mainly in agriculture 152 74 6 57 66 12 446 0 5338 26 843 0 157 7177 
8.c. Products/substances used or intended to 
be used mainly in industry 144 826 1761 653 1759 146 864 0 108 830 4179 0 183 11453 
8.d. Products/substances used or intended to 
be used mainly in the household 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries 0 0 0 0 0 0 0 0 0 0 0 0 0 0 
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 0 0 68 3 79 3 1150 0 0 231 165 0 262 1961 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption 0 0 0 0 0 0 160 0 0 0 423 0 0 583 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 1 134 535 1713 0 0 0 404 28 804 219 0 264 0 5101 
8.i. Other toxicological or safety 
evaluations 0 0 0 0 44 0 0 208 0 0 0 0 963 1215 
8.j. TOTAL 1430 1554 6748 941 2367 167 4493 236 7525 2906 6571 264 4443 39645 
 
EN 55   ENPOLAND  
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 purpos es, 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 responsib le for enforcing the act.  
Every animal experiment to be performed has to be recommended by a recognized 
ethical review committee (Local Commissi on for Ethics in Animal Experiments 
(LKE)). At the moment 18  ethical review committees are recognized. They are 
supervised by National Commission for Et hics in Animal Experiments (KKE). 
Members of KKE and LKE are independent on public administration institutions and 
user establishments. Licenses  to perform animal experi ments 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 anim als 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 Europ ean 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 br eeding or supplying 
establishments within Pola nd, 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 56   EN31,67 % of the animals were used in th e research, development, production and 
quality control of products and devices for human medicine, dentis try and veterinary 
medicine. 
6,18 % of the animals were used in toxicological studies. 8,93 % of the animals were used for dia gnosis 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 othe r birds in comparison to other Member 
States? 
Almost 80% of 'other rodents' used for expe riments in Poland are conducted at one of 
the largest academic centres, which collaborat es with internati onal universities and 
research institutes. Many experiments within  the framework of international research 
projects are performed in Poland. It is im portant to emphasize that these research 
studies chiefly concern environmental res earch 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 sp ecies to Poland (eg, wolves, bears etc).  
The number of horses, donkeys and crossbreed s used in experiment s is higher than in 
other Member States due to the Polish tr adition of horse-br eeding. These include 
studying new breeding programmes, assessmen t of transport conditions and nutrition, 
for example. 
Poland produces a large amount of pork, beef and milk, therefore sc ientific 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 e ffects 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 subs tances (required by 
Polish law), and ecological field studies on bird populations and the influence of 
agriculture on th e bird population. 
 
EN 57   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 126492 119158 2772 790 3772  
1.b. Rats ( Rattus norvegicus ) 51558 50988 0 32 538  
1.c. Guinea-Pigs ( Cavia porcellus ) 10763 10731 0 0 32  
1.d. Hamsters ( Mesocricetus ) 243 194 0 0 49  
1.e. Other Rodents (other Rodentia ) 10826      
1.f. Rabbits ( Oryctolagus cuniculus ) 3101 2879 0 0 222 0 
1.g. Cats ( Felis catus ) 121 67 0 0 54 0 
1.h. Dogs ( Canis familiaris ) 618 419 0 0 199 0 
1.i. Ferrets ( Mustela putorius furo ) 19 14 0 0 5 0 
1.j. Other Carnivores (other Carnivora ) 6970      
1.k. Horses, donkeys and cross breds ( Equidae ) 681      
1.l. Pigs ( Sus) 7358      
1.m. Goats ( Capra ) 130      
1.n. Sheep ( Ovis)  2023      
1.o. Cattle ( Bos) 13834      
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 0 0 0 0 0 0 
1.r. Old World Monkeys ( Cercopithecoidea ) 0 0 0 0 0 0 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 5061      
1.u. Quail ( Coturnix coturnix)  1470 1470 0 0 0  
1.v. Other birds (other Aves ) 61148      
1.w. Reptiles ( Reptilia ) 121      
1.x. Amphibians ( Amphibia ) 13216      
1.y. Fish ( Pisces ) 43076      
1.z. TOTAL 358829      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes need to be completed.  
Note 3: The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2  
 
EN 58   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 45285 28377 20196 3676 13370 14217 860 511 126492 
2.b. Rats 33154 4018 5754 105 3709 3877 767 174 51558 
2.c. Guinea-Pigs 579 0 7158 996 1557 444 21 8 10763 
2.d. Hamsters 138 31 0 0 0 70 4 0 243 
2.e. Other Rodents 10250 0 0 0 356 20 34 166 10826 
2.f. Rabbits 754 68 1174 439 147 233 72 214 3101 
2.g. Cats 24 0 45 50 0 0 2 0 121 
2.h. Dogs 319 9 0 21 29 133 77 30 618 
2.i. Ferrets 5 0 0 14 0 0 0 0 19 
2.j. Other Carnivores 6970 0 0 0 0 0 0 0 6970 
2.k. Horses, donkeys and cross 
breds 611 0 0 0 5 30 35 0 681 
2.l. Pigs 6978 8 0 0 20 13 19 320 7358 
2.m. Goats 60 6 0 0 0 36 27 1 130 
2.n. Sheep 1796 61 0 0 72 0 63 31 2023 
2.o. Cattle 12969 40 0 41 88 48 53 595 13834 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 0 0 0 0 0 0 0 0 0 
2.r. Old World Monkeys 0 0 0 0 0 0 0 0 0 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 5058 0 0 0 0 0 3 0 5061 
2.u. Quail 1033 0 0 0 372 0 65 0 1470 
2.v. Other birds 17194 40126 472 758 120 302 529 1647 61148 
2.w. Reptiles 80 0 0 0 0 0 41 0 121 
2.x. Amphibians 12200 0 0 0 0 0 1016 0 13216 
2.y. Fish 35536 0 0 0 2315 300 515 4410 43076 
2.z. TOTAL 190993 72744 34799 6100 22160 19723 4203 8107 358829 
 
EN 59   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami-
nants in the 
general envi-
ronment which 
do not appear in 
other columns 3.10 
Other toxico-
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 9186 24    40  100 4020 13370 
3.b. Rats 1450 460 665 31    128 975 3709 
3.c. Guinea-Pigs 1459 98        1557 
3.d. Hamsters          0  
3.e. Other Rodents  28 28     300  356 
3.f. Rabbits 126 9 6 6      147 
3.g. Cats          0  
3.h. Dogs        29  29 
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds  5        5 
3.l. Pigs      20    20 
3.m. Goats          0  
3.n. Sheep        72  72 
3.o. Cattle 8      80   88 
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail  372        372 
3.v. Other birds       120   120 
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish 200 2079      36  2315 
3.z. TOTAL 12429 3075 699 37 0 60 200 665 4995 22160 
 
EN 60   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 2924 37604 7473 10829 3546 62376 
4.b. Rats 3110 16646 550 6604 86 26996 
4.c. Guinea-Pigs  4   444 448 
4.d. Hamsters    70  70 
4.e. Other Rodents  389  20  409 
4.f. Rabbits 60  5 228  293 
4.g. Cats    18 9 27 
4.h. Dogs   9  148 157 
4.i. Ferrets      0 
4.j. Other Carnivores     35 35 
4.k. Horses, donkeys and cross breds 8    36 44 
4.l. Pigs 45    40 85 
4.m. Goats     5 5 
4.n. Sheep 4   21 42 67 
4.o. Cattle     135 135 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail      0 
4.v. Other birds    152 490 642 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish     500 500 
4.z. TOTAL 6151 54643 8037 17942 5516 92289 
 
EN 61   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 7474 8615  705 2398 4680 23872 
5.b. Rats  5412  129 318  5859 
5.c. Guinea-Pigs 1408 5813  20 10 903 8154 
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits 596 300  16 501 200 1613 
5.g. Cats 76 11   8  95 
5.h. Dogs 21      21 
5.i. Ferrets 14      14 
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds       0  
5.l. Pigs       0  
5.m. Goats       0  
5.n. Sheep       0  
5.o. Cattle  41     41 
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds 1230      1230 
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 10819 20192 0 870 3235 5783 40899 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 62   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 3818 8290  20  1242 13370 
6.b. Rats 1836 1357    516 3709 
6.c. Guinea-Pigs  1557     1557 
6.d. Hamsters       0  
6.e. Other Rodents      356 356 
6.f. Rabbits  147     147 
6.g. Cats       0  
6.h. Dogs  29     29 
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds  5     5 
6.l. Pigs      20 20 
6.m. Goats       0  
6.n. Sheep      72 72 
6.o. Cattle 8     80 88 
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail  372     372 
6.v. Other birds      120 120 
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish  2279    36 2315 
6.z. TOTAL 5662 14036 0 20 0 2442 22160 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 63   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcinog
enicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta-
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 306 7370 152    364      5178 13370 
7.b. Rats 165  385    1651  316  371  821 3709 
7.c. Guinea-Pigs  420 756 60 313        8 1557 
7.d. Hamsters              0  
7.e. Other Rodents 56      300       356 
7.f. Rabbits    72  36       39 147 
7.g. Cats              0  
7.h. Dogs           29   29 
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds             5  5  
7.l. Pigs             20 20 
7.m. Goats              0  
7.n. Sheep         35  37   72 
7.o. Cattle             88 88 
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail 180          192   372 
7.v. Other birds             120 120 
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish 2179          36 100  2315 
7.z. TOTAL 2886 7790 1293 132 313 36 2315 0 351 0 665 100 6279 22160 
 
EN 64   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcinog
enicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 531 7750 946 123 215 24 711  316   100 1713 12429 
8.b. Products/substances used or intended to 
be used mainly in agriculture 2302  21 3 98 6 224    416  5 3075 
8.c. Products/substances used or intended to 
be used mainly in industry 33  315 3  3 198    147   699 
8.d. Products/substances used or intended to 
be used mainly in the household 20  11 3  3        37 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption  40           20 60 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption             200 200 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns       528  35  102   665 
8.i. Other toxicological or safety 
evaluations       654      4341 4995 
8.j. TOTAL 2886 7790 1293 132 313 36 2315 0 351 0 665 100 6279 22160 
 
EN 65   ENPORTUGAL  
Statistical data submitted 
The statistical data have been submitte d by the “Ministério da Agricultura, 
Desenvolvimento Rural e das Pescas – Direcç ão Geral de Veterinária” (Ministry of 
Agriculture, Rural Development and Fisher ies – General Directi on of Veterinary – 
Directorate for Animal Medicines a nd 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 to tal 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 th e 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 represen t 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 Port ugal, 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 an imals) and in 2005 
(41621 animals) are represente d in the following table: 
Class of 
animals (%) 2002 2005 
Mice 62 68,04 
Rats  27,6 16,32 
Guinea-pigs 1,42 0,91 
Hamsters and 
other rodents 0,21 0,31 
Rabbits 2,04 1,43 
Cold-blooded 
animals 5,38 11,53 
 
EN 66   ENQuail and other 
birds 0,44 0,27 
Artio 
Perissodactyla 0,88 1,11 
Carnivors 0,08 0,09 
Looking at the data by groups of species, th e 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 increa se 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 de crease 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 Goat s 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 de vices 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 speci es versus experimental pur poses, the highest amount of 
use of Mice and of Rats is in Fundamental  biology and in Research and development 
for human medicine, veterina ry 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 67   ENThe other increase that occurr ed was in the percentage of animals used in Production 
and quality control of products  and devices in human medi cine and dentistry, which 
increased from 0,8% in 2002, to 1,72% in 2005. 
The use of animals in the rest of the ot her categories decreased, for example:  
The percentage of animals used for T oxicological and other safety evaluation 
decreased from 2,92% to 2,26% (from 1301 to 939 animals); 
The percentage of animals used for Edu cation and training d ecreased from 4,78% to 
3,02% (from 2132 to 1258 animals); 
The percentage of animals used for Othe r purposes decreased from 2,41% to 1,39% 
(from 1075 to 577 animals) 
1. Number of animals used for Toxicologi cal and safety evaluation by type 
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 a nd dentistry and for veterinary medicine 
represents 52,08% of the anim al used for Toxicological an d other safety evaluation; 
Potential or actual contaminants in the ge neral environment which do not appear in 
other columns represents 21,30% and Other toxicological or sa fety evaluations 
represent 26,62%.  
Comparison with the data of the previous report (data of 2002) . 
Compared to the data of 2002, in 2005 ther e was a decrease on the use of animals in 
Toxicological and other safety evaluati on. 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 categor y of products that we re tested in 2005.  
Products or devices for human medicine a nd dentistry and for veterinary medicine 
represented, in 2002, 20,67% of the animal us ed 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 pr oducts/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 decr ease in the number of animals used for 
Other toxicological or safety evaluati on 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 to tal number of animals (41621 animals) 
that were used. 
 
EN 68   ENThe percentages of animals pe r type of diseases were: 
3,28% in Human cardiovascular diseases; 24,89% in Human nervous and mental disorders; 2,28% in Human cancer (excl. ev aluation 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 animal s) 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 fo r the study of animal diseases.  
In general terms, the proportion of animals us ed 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 
3. Number of animals used for Toxicologi cal and other safety evaluations by 
the types of tests  
As pointed out earlier, in 2005, the use of an imals 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 Toxicologi cal and other safety 
evaluation in 2002 (1301 animals) and in 2005  (939 animals) are represented in the 
following table: 
Type of tests (%) 2002 2005 
Acute and sub-acute 
toxicity testing methods (including limit test) 14,37 37,6 
Irritation/sensitization 
tests  6,53 27,8 
Sub-chronic and chronic 
toxicity 0 0 
Mutagenicity and 
carcinogenicity 8,84 32 
Reproductive and 
developmental toxicity 49,19 0 
 
EN 69   ENToxicity of aquatic 
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 pr evious report (data 2002). 
The use of animals used for Reproductive a nd developmental toxicity tests decreased 
from 49,19% in 2002, to 0% in 2005. 
Contrary to what happened for the 25 Memb er States, the use of animals in 2005 for 
“Other tests” decreased from 21,1% in 2002, to 2,7% in 2005. 
4. Type of toxicity tests carried out for Toxicological and other safety evaluations 
of products  
As pointed out earlier, in 2005, the use of an imals 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 Toxicologi cal 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 
Products/substances or 
devices for human medicine and dentistry and for veterinary medicine 269 689 
Potential or actual 
contaminants in the general environment which do not appear in other columns 162 0 
Other toxicological or 
safety evaluations 870 250 
In 2005, the number of animals used to test Products/substances or devices for human 
medicine and dentistry and for veteri nary medicine were the following:  
300 animals in Carcinogenicity and Mutage nicity (in 2002, they were 100 animals); 
 
EN 70   EN261 animals in Irritation/sensitisation tests (in 2002, they were 85 animals); 
103 animals in Acute and sub-acu te 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 an imals in Acute and sub-acute toxicity 
testing methods (includi ng limit test) and 640 anim als in Reproductive and 
developmental toxicity tests). 
 
EN 71   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 28318 19975 5838 49 2456 50 
1.b. Rats ( Rattus norvegicus ) 6793 2362 4236  195  
1.c. Guinea-Pigs ( Cavia porcellus ) 379 102   277  
1.d. Hamsters ( Mesocricetus ) 129 18 111    
1.e. Other Rodents (other Rodentia )       
1.f. Rabbits ( Oryctolagus cuniculus ) 594 349   245 20 
1.g. Cats ( Felis catus )       
1.h. Dogs ( Canis familiaris ) 36    36 10 
1.i. Ferrets ( Mustela putorius furo )       
1.j. Other Carnivores (other Carnivora )       
1.k. Horses, donkeys and cross breds ( Equidae ) 8      
1.l. Pigs ( Sus) 113      
1.m. Goats ( Capra ) 4      
1.n. Sheep ( Ovis)  290      
1.o. Cattle ( Bos) 45      
1.p. Prosimians ( Prosimia )       
1.q. New World Monkeys ( Ceboidea )       
1.r. Old World Monkeys ( Cercopithecoidea )       
1.s. Apes ( Hominoidea )       
1.t. Other Mammals (other Mammalia ) 1      
1.u. Quail ( Coturnix coturnix)        
1.v. Other birds (other Aves ) 112      
1.w. Reptiles ( Reptilia )      12 
1.x. Amphibians ( Amphibia ) 51    1  
1.y. Fish ( Pisces ) 4748      
1.z. TOTAL 41621      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, are Parties to the Convention ETS 123. Thus an updated list 
of those countries has to be us ed when filling in  this column. 
Note 2: Only the white b oxes 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 72   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 23396 1075 700 977 440 994 471 265 28318 
2.b. Rats 4249 1612   200 113 561 58 6793 
2.c. Guinea-Pigs 65   110 2 8 25 169 379 
2.d. Hamsters  115      14 129 
2.e. Other Rodents          
2.f. Rabbits 3 19 15 245 261 1 25 25 594 
2.g. Cats          
2.h. Dogs     36    36 
2.i. Ferrets          
2.j. Other Carnivores          
2.k. Horses, donkeys and cross 
breds       8  8 
2.l. Pigs 33      78 2 113 
2.m. Goats       4  4 
2.n. Sheep 272   4   8 6 290 
2.o. Cattle 37      8  45 
2.p. Prosimians          
2.q. New World Monkeys          
2.r. Old World Monkeys          
2.s. Apes          
2.t. Other Mammals  1       1 
2.u. Quail          
2.v. Other birds 6   69    37 112 
2.w. Reptiles          
2.x. Amphibians       50 1 51 
2.y. Fish 4728      20  4748 
2.z. TOTAL 32789 2822 715 1405 939 1116 1258 577 41621 
 
EN 73   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami- 
nants in the 
general envi- 
ronment which 
do not appear in 
other columns 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 190        250 440 
3.b. Rats        200   
3.c. Guinea-Pigs 2         2 
3.d. Hamsters           
3.e. Other Rodents           
3.f. Rabbits 261         261 
3.g. Cats           
3.h. Dogs 36         36 
3.i. Ferrets           
3.j. Other Carnivores           
3.k. Horses, donkeys and cross breds           
3.l. Pigs           
3.m. Goats           
3.n. Sheep           
3.o. Cattle           
3.p. Prosimians           
3.q. New World Monkeys           
3.r. Old World Monkeys           
3.s. Apes           
3.t. Other Mammals           
3.u. Quail           
3.v. Other birds           
3.w. Reptiles           
3.x. Amphibians           
3.y. Fish           
3.z. TOTAL 489       200 250 939 
 
EN 74   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 66 2126 436 12509 247 15384 
4.b. Rats 459 2696 3 658  3816 
4.c. Guinea-Pigs    2  2 
4.d. Hamsters 111   14  125 
4.e. Other Rodents       
4.f. Rabbits       
4.g. Cats       
4.h. Dogs       
4.i. Ferrets       
4.j. Other Carnivores       
4.k. Horses, donkeys and cross breds       
4.l. Pigs   2  2 4 
4.m. Goats       
4.n. Sheep     4 4 
4.o. Cattle       
4.p. Prosimians       
4.q. New World Monkeys       
4.r. Old World Monkeys       
4.s. Apes       
4.t. Other Mammals       
4.u. Quail       
4.v. Other birds    19 18 37 
4.w. Reptiles       
4.x. Amphibians       
4.y. Fish       
4.z. TOTAL 636 4822 441 13202 271 19372 
 
EN 75   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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 977     700 1677 
5.b. Rats        
5.c. Guinea-Pigs 110      110 
5.d. Hamsters        
5.e. Other Rodents        
5.f. Rabbits 220 40     260 
5.g. Cats        
5.h. Dogs        
5.i. Ferrets        
5.j. Other Carnivores        
5.k. Horses, donkeys and cross breds        
5.l. Pigs        
5.m. Goats        
5.n. Sheep 4      4 
5.o. Cattle        
5.p. Prosimians        
5.q. New World Monkeys        
5.r. Old World Monkeys        
5.s. Apes        
5.t. Other Mammals        
5.u. Quail        
5.v. Other birds 69      69 
5.w. Reptiles        
5.x. Amphibians        
5.y. Fish        
5.z. TOTAL 1380 40    700 2120 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 76   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 77   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Regulatory requirements versus species 
6.1 
Species 6.2  
National legislation 
specific to a single EC 
Member State 
1) 6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 6.5 
Other legislation 6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 6.7 
No regulatory 
requirements 6.8 
Total 
6.a. Mice 25 315    100 440 
6.b. Rats 200      200 
6.c. Guinea-Pigs  2     2 
6.d. Hamsters        
6.e. Other Rodents        
6.f. Rabbits  261     261 
6.g. Cats        
6.h. Dogs  36     36 
6.i. Ferrets        
6.j. Other Carnivores        
6.k. Horses, donkeys and cross breds        
6.l. Pigs        
6.m. Goats        
6.n. Sheep        
6.o. Cattle        
6.p. Prosimians        
6.q. New World Monkeys        
6.r. Old World Monkeys        
6.s. Apes        
6.t. Other Mammals        
6.u. Quail        
6.v. Other birds        
6.w. Reptiles        
6.x. Amphibians        
6.y. Fish        
6.z. TOTAL 225 614    100 939 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 78   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino- 
genicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta- 
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 100 215        100   25 440 
7.b. Rats        200      200 
7.c. Guinea-Pigs  2            2 
7.d. Hamsters               
7.e. Other Rodents               
7.f. Rabbits      261        261 
7.g. Cats               
7.h. Dogs   36           36 
7.i. Ferrets               
7.j. Other Carnivores               
7.k. Horses, donkeys and cross 
breds               
7.l. Pigs               
7.m. Goats               
7.n. Sheep               
7.o. Cattle               
7.p. Prosimians               
7.q. New World Monkeys               
7.r. Old World Monkeys               
7.s. Apes               
7.t. Other Mammals               
7.u. Quail               
7.v. Other birds               
7.w. Reptiles               
7.x. Amphibians               
7.y. Fish               
7.z. TOTAL 100 217 36   261  200  100   25 939 
 
EN 79   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine  103    261  200  100   25 689 
8.b. Products/substances used or intended to 
be used mainly in agriculture               
8.c. Products/substances used or intended to 
be used mainly in industry               
8.d. Products/substances used or intended to 
be used mainly in the household               
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries               
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption               
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption               
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns               
8.i. Other toxicological or safety 
evaluations 100 150            250 
8.j. TOTAL 100 253    261  200  100   25 939 
 
EN 80   EN FINLAND  
Statistical data submitted 
The statistical data have been submitted by the “ Maa – ja metsätalousmini steriö Elintarvike- 
ja terveysosasto ” (Ministry of Agriculture and Forest ry, Veterinary and Food Department). 
Comments of Finnish authorities  
Report from Finland 2005 
In year 2005, 256826 experimental animals were us ed in Finland. Fish were used 20 % more 
than in 2004. The total amount of  animals of other species us ed 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 vari ed 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 av erage in 2000-2004, but 
of rats 12% lower, respectively. Of all experimental animals used 60 % were rodents, and 93 % of fish are excluded from th e total, respectively. No cats we re 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 us ed as experimental an imals in Finland in 2005. 
Major part (87 %) of the animal s were used for biological studi es 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 evaluatio ns 0,9 %, for diagnosis of disease 0,2 %, for 
education and training 1,8 % an d other uses 0,9 % of the to tal number of experimental 
animals used, respectively. No major differences  in comparison to the previous year were 
observed. 
Preparations for a revision of the Finnish legi slation concerning use of experimental animals 
proceeded to final drafts during year 2005 and was planned to be passed in 2006. 
Ministry of Agriculture and Fo restry funded Finnish research for studies to replace existing 
techniques using experimental animals with alternative methods with 27 000 € in year 2005. 
 
EN 81   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 120636 87684 32362 247 343  
1.b. Rats ( Rattus norvegicus ) 28358 10869 17365  124  
1.c. Guinea-Pigs ( Cavia porcellus ) 563  563    
1.d. Hamsters ( Mesocricetus ) 126 6 120    
1.e. Other Rodents (other Rodentia ) 3187      
1.f. Rabbits ( Oryctolagus cuniculus ) 1214 500 714    
1.g. Cats ( Felis catus ) 0 0     
1.h. Dogs ( Canis familiaris ) 103 8 95    
1.i. Ferrets ( Mustela putorius furo ) 80 80     
1.j. Other Carnivores (other Carnivora ) 5 0   1  
1.k. Horses, donkeys and cross breds ( Equidae ) 125 125     
1.l. Pigs ( Sus) 1471      
1.m. Goats ( Capra ) 73      
1.n. Sheep ( Ovis)  445      
1.o. Cattle ( Bos) 455 455     
1.p. Prosimians ( Prosimia ) 0 0     
1.q. New World Monkeys ( Ceboidea ) 0 0     
1.r. Old World Monkeys ( Cercopithecoidea ) 0 0     
1.s. Apes ( Hominoidea ) 0 0     
1.t. Other Mammals (other Mammalia ) 972 0     
1.u. Quail ( Coturnix coturnix)  0 0     
1.v. Other birds (other Aves ) 5773 890 10    
1.w. Reptiles ( Reptilia ) 0 0     
1.x. Amphibians ( Amphibia ) 20      
1.y. Fish ( Pisces ) 93220      
1.z. TOTAL 256826 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 perio d, 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 b oxes 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 82   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 111502 7761 100  585 25 581 82 120636 
2.b. Rats 13749 11885 100  1374 17 791 442 28358 
2.c. Guinea-Pigs  352 24  79  24 84 563 
2.d. Hamsters 126        126 
2.e. Other Rodents 3187        3187 
2.f. Rabbits 514 467 54  75 1 85 18 1214 
2.g. Cats         0 
2.h. Dogs  47   56    103 
2.i. Ferrets 80       80 
2.j. Other Carnivores 5        5 
2.k. Horses, donkeys and cross 
breds 110 15       125 
2.l. Pigs 445 141 203    82 600 1471 
2.m. Goats  4     69  73 
2.n. Sheep 22 43 380      445 
2.o. Cattle 277      178  455 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals 972        972 
2.u. Quail         0 
2.v. Other birds 2515 8  2209   41 1000 5773 
2.w. Reptiles         0 
2.x. Amphibians       20  20 
2.y. Fish 90011    72 317 2820  93220 
2.z. TOTAL 223515 20723 861 2209 2241 360 4691 2226 256826 
 
EN 83   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami- 
nants in the 
general envi- 
ronment which 
do not appear in 
other columns 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 265        320 585 
3.b. Rats 758        616 1374 
3.c. Guinea-Pigs 79         79 
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits 75         75 
3.g. Cats          0  
3.h. Dogs 56         56 
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle          0  
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail          0  
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish        72  72 
3.z. TOTAL 1233 0 0 0 0 0 0 72 936 2241 
 
EN 84   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 3629 6400 8652 18885  37566 
4.b. Rats 3408 9683 266 4118  17475 
4.c. Guinea-Pigs 332     332 
4.d. Hamsters    120  120 
4.e. Other Rodents      0 
4.f. Rabbits 195 15  362  572 
4.g. Cats      0 
4.h. Dogs 75 12    87 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs 218     218 
4.m. Goats      0 
4.n. Sheep    39 22 61 
4.o. Cattle     6 6 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals     6 6 
4.u. Quail      0 
4.v. Other birds     8 8 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish     385 385 
4.z. TOTAL 7857 16110 8918 23524 427 56836 
 
EN 85   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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  80 20    100 
5.b. Rats      100 100 
5.c. Guinea-Pigs      24 24 
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits  4    50 54 
5.g. Cats       0  
5.h. Dogs       0  
5.i. Ferrets       0  
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds       0  
5.l. Pigs     171 32 203 
5.m. Goats       0  
5.n. Sheep     380  380 
5.o. Cattle       0  
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds      2209 2209 
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 0 84 20 0 551 2415 3070 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 86   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Regulatory requirements versus species 
6.1 
Species 6.2  
National legislation 
specific to a single EC 
Member State 
1) 6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 6.5 
Other legislation 6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 6.7 
No regulatory 
requirements 6.8 
Total 
6.a. Mice 40 55   490  585 
6.b. Rats  127   1151 96 1374 
6.c. Guinea-Pigs     79  79 
6.d. Hamsters       0  
6.e. Other Rodents       0  
6.f. Rabbits  8   67  75 
6.g. Cats       0  
6.h. Dogs  56     56 
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats       0  
6.n. Sheep       0  
6.o. Cattle       0  
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail       0  
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish      72 72 
6.z. TOTAL 40 246 0 0 1787 168 2241 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 87   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino- 
genicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta- 
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice   375    40      170 585 
7.b. Rats   520    17    100  737 1374 
7.c. Guinea-Pigs             79 79 
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits       8      67 75 
7.g. Cats              0  
7.h. Dogs       56       56 
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep              0  
7.o. Cattle              0  
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail              0  
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish            72  72 
7.z. TOTAL 0 0 895 0 0 0 121 0 0 0 100 72 1053 2241 
 
EN 88   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine   895    121    100  957 2073 
8.b. Products/substances used or intended to 
be used mainly in agriculture              0  
8.c. Products/substances used or intended to 
be used mainly in industry              0  
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption              0  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns            72  72 
8.i. Other toxicological or safety 
evaluations             96 96 
8.j. TOTAL 0 0 895 0 0 0 121 0 0 0 100 72 1053 2241 
 
EN 89   ENSLOVENIA 
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 pr otection of experimental animals has been 
harmonised with the relevant EU legisl ation. 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 anim als (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 Admi nistration 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 orga nisation employs an animal welfare expert, 
who is responsible for compiling on a specifi cally 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 e nvisaged for annual reporting includes eight 
tables and as Annex 5 constitutes an inte gral part of the Ru les 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 animal s. 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 co mpared to 2004, where 13,538 animals were 
used in experiments, the nu mber of animals used in e xperiments 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 la boratory 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, amounti ng to 8.5 % less ra bbits as compared to 2004. In 2005, a 
collective number of 114 other animals we re 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 90   ENIt 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 with in the Republic of Slovenia. Mostly used 
were laboratory rodents ( 94.6 %). From the collective number of experimental 
animals, the animals reused in expe riments included the rabbits and dogs.  
As regards animals used in experiment s for selected purposes as shown in Table 2 , in 
2005, most animals were used in pharmaceutic al 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 de vices 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 anim als (975 laboratory r odents 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 toxico logical and other safety evaluations. In 
2005, 965 laboratory rodents were used in th e acute and sub-acute toxicity testing 
methods, or in LD 50 and LC  50 determination, and 10 labor atory rats, 45 rabbits and 
34 sheep in other toxicologi cal and safety evaluations. 
Table 8  shows that 965 animals were used in  the toxicological and other safety 
evaluations for products/substances or de vices for human medi cine, dentistry and 
veterinary medicine, and 34 animals for other purposes of  toxicological or safety 
evaluations, whilst 55 animals were used  in tests of repr oduction toxicity of 
products/substances intended for use in agriculture. 
Quality control of products and devices for human medicine, dentis try and veterinary 
medicine, and toxicological a nd other safety evaluations of substances are conducted 
in accordance with the applicable legi slation, the requirements of relevant 
Pharmacopoeias, and in accordance w ith the international regulations. 
Table 5  shows that in accordance with EU le gislation, including the requirements of 
the European Pharmacopoeia, 5,916 animals in  total were used in the production and 
quality control of products and devices fo r 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 me dicine, veterinary 
medicine, biology and zootechnics use animal s 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, wh ich amounts to 15.7 % of all animals used, 
including in particular la boratory rodents (98.9 %), so me dogs, sheep and birds. 
In 2005, animals were used to a lesser extent for diagnosi ng diseases (3.1 %), 
educational and training purposes (2.3  %), and other purposes (0.1 %).  
 
EN 91   ENTable 4 shows the number and species of an imals 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 hum ans. A total of 735 animals were used for 
studies of nervous and mental disorder s in humans, 422 animals for studies of 
cardiovascular diseases, and 629 animals fo r studies of other diseases. Laboratory 
rodents were used predominantly, and some rabbits and sheep. 
An important role in decreasing the number of animals used in experiments plays in 
particular the legislation, and the substitu tion of animals by alternative methods where 
so required by law, the requirement for specific authorisations  of experiments, 
appropriate staff training, successful cooperation between the institutes and 
researchers at the national and international levels, as well as the active involvement 
of animal protection and we lfare societies. A further important contribution to 
decreasing the number of animals used in e xperiments is the res ponsibility on the part 
of researchers and their improved attitude to wards experimental animals as the plans 
and protocols of experiments are more prec ise 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 intersta te/international recognition of results 
obtained in experiments on animals, th e 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 92   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 8556 8556     
1.b. Rats ( Rattus norvegicus ) 2732 2727 5    
1.c. Guinea-Pigs ( Cavia porcellus ) 38 38     
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia ) 18      
1.f. Rabbits ( Oryctolagus cuniculus ) 533 533    466 
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 15 15    6 
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora ) 0      
1.k. Horses, donkeys and cross breds ( Equidae ) 1      
1.l. Pigs ( Sus) 16      
1.m. Goats ( Capra ) 0      
1.n. Sheep ( Ovis)  57      
1.o. Cattle ( Bos) 0      
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia ) 0      
1.u. Quail ( Coturnix coturnix)  0      
1.v. Other birds (other Aves ) 22      
1.w. Reptiles ( Reptilia ) 3      
1.x. Amphibians ( Amphibia ) 0      
1.y. Fish ( Pisces ) 0      
1.z. TOTAL 11991      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 93   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 760 2157 4467 240 478 334 104 16 8556 
2.b. Rats 1087 293 743  497  112  2732 
2.c. Guinea-Pigs 22     9 7  38 
2.d. Hamsters          
2.e. Other Rodents      16 2  18 
2.f. Rabbits   466  45 1 21  533 
2.g. Cats          
2.h. Dogs 7      2 6 15 
2.i. Ferrets          
2.j. Other Carnivores          
2.k. Horses, donkeys and cross 
breds       1  1 
2.l. Pigs       16  16 
2.m. Goats          
2.n. Sheep 5    34 18   57 
2.o. Cattle          
2.p. Prosimians          
2.q. New World Monkeys          
2.r. Old World Monkeys          
2.s. Apes          
2.t. Other Mammals          
2.u. Quail          
2.v. Other birds 7      15  22 
2.w. Reptiles       3  3 
2.x. Amphibians          
2.y. Fish          
2.z. TOTAL 1888 2450 5676 240 1054 378 283 22 11991 
 
EN 94   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami- 
nants in the 
general envi- 
ronment which 
do not appear in 
other columns 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 478         478 
3.b. Rats 497         497 
3.c. Guinea-Pigs           
3.d. Hamsters           
3.e. Other Rodents           
3.f. Rabbits         4 5  4 5  
3.g. Cats           
3.h. Dogs           
3.i. Ferrets           
3.j. Other Carnivores           
3.k. Horses, donkeys and cross breds           
3.l. Pigs           
3.m. Goats           
3.n. Sheep 34         34 
3.o. Cattle           
3.p. Prosimians           
3.q. New World Monkeys           
3.r. Old World Monkeys           
3.s. Apes           
3.t. Other Mammals           
3.u. Quail           
3.v. Other birds           
3.w. Reptiles           
3.x. Amphibians           
3.y. Fish           
3.z. TOTAL 1009        45 1054 
 
EN 95   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 99   426  525 
4.b. Rats 323 735  157  1215 
4.c. Guinea-Pigs    22  22 
4.d. Hamsters       
4.e. Other Rodents    16  16 
4.f. Rabbits       
4.g. Cats       
4.h. Dogs       
4.i. Ferrets       
4.j. Other Carnivores       
4.k. Horses, donkeys and cross breds       
4.l. Pigs       
4.m. Goats       
4.n. Sheep    8  8 
4.o. Cattle       
4.p. Prosimians       
4.q. New World Monkeys       
4.r. Old World Monkeys       
4.s. Apes       
4.t. Other Mammals       
4.u. Quail       
4.v. Other birds       
4.w. Reptiles       
4.x. Amphibians       
4.y. Fish       
4.z. TOTAL 422 735  629  1786 
 
EN 96   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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  4707     4707 
5.b. Rats  743     743 
5.c. Guinea-Pigs        
5.d. Hamsters        
5.e. Other Rodents        
5.f. Rabbits  466     466 
5.g. Cats        
5.h. Dogs        
5.i. Ferrets        
5.j. Other Carnivores        
5.k. Horses, donkeys and cross breds        
5.l. Pigs        
5.m. Goats        
5.n. Sheep        
5.o. Cattle        
5.p. Prosimians        
5.q. New World Monkeys        
5.r. Old World Monkeys        
5.s. Apes        
5.t. Other Mammals        
5.u. Quail        
5.v. Other birds        
5.w. Reptiles        
5.x. Amphibians        
5.y. Fish        
5.z. TOTAL  5916     5916 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 97   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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  478     478 
6.b. Rats  487   0 10 497 
6.c. Guinea-Pigs       0  
6.d. Hamsters       0  
6.e. Other Rodents      45 45 
6.f. Rabbits       0  
6.g. Cats       0  
6.h. Dogs       0  
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats      34 34 
6.n. Sheep       0  
6.o. Cattle       0  
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail       0  
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish       0  
6.z. TOTAL 0 965 0 0 0 89 1054 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 98   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino- 
genicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta- 
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 478             478 
7.b. Rats 487            10 497 
7.c. Guinea-Pigs              0  
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits             45 45 
7.g. Cats              0  
7.h. Dogs              0  
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep             34 34 
7.o. Cattle              0  
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail              0  
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish              0  
7.z. TOTAL 965 0 0 0 0 0 0 0 0 0 0 0 89 1054 
 
EN 99   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 965            34 999 
8.b. Products/substances used or intended to 
be used mainly in agriculture           55   55 
8.c. Products/substances used or intended to 
be used mainly in industry              0  
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption              0  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns              0  
8.i. Other toxicological or safety 
evaluations              0  
8.j. TOTAL 965 0 0 0 0 0 0 0 0 0 55 0 34 1054 
 
EN 100   ENSLOVAKIA 
Statistical data submitted 
The statistical data have been submitted by the  State Veterinary and Food 
Administration of the Slovak Republ ic, Botanická 17, 842 13 Bratislava 
Comments of Slovakian authorities  
National comments to the statistical evalua tion of data concerning the number of 
experimental animals used in experiments in the year 2005 in the Slovak Republic. 
The State Veterinary and Food Administratio n 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 admi nistration in the fiel d 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 "Ordinan ce of the Government of the 
Slovak Republic No. 289/2003 Coll.".), ex perimental, breeding and supplying 
establishments and all the experiments pe rformed 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 establ ishment for housing, 
breeding, care and the use of animals fo r experiments, issued by the RVFA) in 
compliance with Article 12 and 16 of the Or dinance 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 establ ishment for the purpose of assessment of 
observance of requirements for approved esta blishment, which are laid down in the 
Ordinance of the Government of the Sl ovak 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 Ordina nce of the Government of the Slovak 
Republic No. 289/2003 Coll. to perform mi nimum once a year non-discriminatory 
controls of all approved establishments fo r the purpose of contro l of observance of 
requirements for approved establishment whic h are laid down in th e Ordinance of the 
Government of the Slovak Republic N o. 289/2003 Coll. The SVFA SR, as a 
competent authority, trained theoretically a nd also practically all the animal welfare 
 
EN 101   ENinspectors for the performance of the co ntrol. Controls are performed based on 
methodical instructions and check lists wo rked 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 th e year 2005, based on applicant’ s applications a total of 
7 new experimental establishments, 1 breeding establishmen t for breeding of 
experimental animals.  
Total number of establishments in the Slovak Republic in the year 2005  
Kind of establishment Number 
Experimental establishment 43 
Experimental establishment with breeding 
of animals for own use 20 
Breeding establishment 7 
Supplying establishment 1 
Total: 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 applicatio n 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 experi mental establishment shall have 
established its own ethic commission comp rised 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 expe riment. The SVFA SR. 
as a competent authority shall issue a d ecision 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 purpos e of the experiment (3R), methods of 
performance of the experiment, origin of  experimental animals, handling, care and 
housing of experimental animals with provi sion laid down in th e Ordinance of the 
Government No. 289/2003 Coll., in complian ce with the valid legislation in the 
Slovak Republic and in the European Uni on. The SVFA SR established, based on the 
Article 8 of the Ordinance of the Gove rnment of the Slovak Republic No. 289/2003 
Coll. advisory body of the chief veterinary o fficer 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 experi ment, the need of use of the animals in 
 
EN 102   ENthe experiment and the number of used anim als shall ask the members of the advisory 
body for opinion - to the submitted application for approval of the experiment- with 
observance of rules of persona l data protection and protecti on 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 establ ishments 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 num ber 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 intr oduction 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 notificati on of the number of 
used animals  
Kind of experiment– purpose of the 
experiment Number of experiments performed 
2.2. Basic research 70 
2.3. Research and development of 
products and devices for human medicine and veterinary medicine and dentistry  79 
2.4. Production and control of quality of 
products and devices for human medicine and dentistry 5 
2.5. Production and control of quality of 
products and devices for veterinary medicine 10 
2.6. Toxicological a nd other safety 
evaluations including evaluation of safety 
of products and devices for human and veterinary medicine and dentistry 62 
2.7. Disease diagnostics 25 
 
EN 103   EN2.8. Education and training 7 
2.9. Other 15 
Total 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 pe sticide, herbicide 
products. In the column 3.4 the animals used for control of various  chemical products/ 
substances being a part of oils, lubric ants 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 system s, 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 Slov ak 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 legislati on of the European 
Pharmacopoeia, in the column 5.5 the expe riments were performed according to the 
valid national legisl ation e.g. STN EN ISO standards.  In the column 5.7 the methods 
in control of human produc ts/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 chem ical substances and preparations the Act 
No. 163/2001 Coll. On Chemical Substances an d Preparations, Decree of the Ministry 
of Economy No. 2/2005 Annex 5 Part B Me thods 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 substa nce 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 OE CD TG 402, 403. In the column 7.2.2. the 
tests OECD TG 423, B.1 tris were performe d. In the column 7.2.3 mainly tests in 
compliance with OECD TG 407, 420, to lerance 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 y early by the end of January for the previous 
year to the SVFA SR a notif ication 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 establis hments 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 wo rk out a notificatio n about the activity of the SVFA SR 
in which the numbers of approved es tablishments and approved or refused 
 
EN 104   ENexperiments 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 sha ll 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 es tablishments for the purpose of control of 
observance of requirements for approved esta blishment indicated in the Ordinance of 
the Government of the Slovak Repub lic No. 289/2003 Coll. The SVFA, as a 
competent authority, has trained theoretica lly and also practically all the animal 
welfare inspectors for performance of the c ontrol. Controls are performed based on 
methodical instructions and check lists wo rked 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 esta blishments is perfor med 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 Ordi nance of the Government of the Slovak 
Republic No. 289/2003 Coll. Controls of an imal welfare are non-discriminatory, 
performed minimum once a year in each approved establishment. The competent authority trained all the inspectors for pe rformance 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 Governme nt 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 natu ral person in compliance with Article 45 
of the Act No. 488/2002 Coll.  
The SVFA SR performs theoretic al and practical trainings of  all workers of veterinary 
administration in performance of control with regard to housi ng, 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 legislat ion 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. th e animal owner, keeper and 
dealer shall be obliged to educate demonstrably the persons handling the animals so that such persons must avoid from any ac ts that might cause injury or any other 
damage to the health of animals or unnecessary suffering thereof.  
Prof. Jozef Bíreš, DVM, DrSc 
 
EN 105   ENChief Veterinary Officer 
 
EN 106   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 14975 9246  5729   
1.b. Rats ( Rattus norvegicus ) 6761 4942 51 1768   
1.c. Guinea-Pigs ( Cavia porcellus ) 594 514  80   
1.d. Hamsters ( Mesocricetus ) 0      
1.e. Other Rodents (other Rodentia )       
1.f. Rabbits ( Oryctolagus cuniculus ) 782 632  150  126 
1.g. Cats ( Felis catus ) 0      
1.h. Dogs ( Canis familiaris ) 6   6   
1.i. Ferrets ( Mustela putorius furo ) 0      
1.j. Other Carnivores (other Carnivora )       
1.k. Horses, donkeys and cross breds ( Equidae )       
1.l. Pigs ( Sus)       
1.m. Goats ( Capra )       
1.n. Sheep ( Ovis)        
1.o. Cattle ( Bos)       
1.p. Prosimians ( Prosimia ) 0      
1.q. New World Monkeys ( Ceboidea ) 0      
1.r. Old World Monkeys ( Cercopithecoidea ) 0      
1.s. Apes ( Hominoidea ) 0      
1.t. Other Mammals (other Mammalia )       
1.u. Quail ( Coturnix coturnix)  251 251     
1.v. Other birds (other Aves )       
1.w. Reptiles ( Reptilia )       
1.x. Amphibians ( Amphibia )       
1.y. Fish ( Pisces )       
1.z. TOTAL 23369      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 107   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 7415 2433 117 482 440 3766 100 222 14975 
2.b. Rats 4857 341   1015 292 50 206 6761 
2.c. Guinea-Pigs 252 122 116  84  3 17 594 
2.d. Hamsters         0 
2.e. Other Rodents         0 
2.f. Rabbits 133 39 161 91 159 178 3 18 782 
2.g. Cats         0 
2.h. Dogs     6    6 
2.i. Ferrets         0 
2.j. Other Carnivores         0 
2.k. Horses, donkeys and cross 
breds         0 
2.l. Pigs         0 
2.m. Goats         0 
2.n. Sheep         0 
2.o. Cattle         0 
2.p. Prosimians         0 
2.q. New World Monkeys         0 
2.r. Old World Monkeys         0 
2.s. Apes         0 
2.t. Other Mammals         0 
2.u. Quail         0 
2.v. Other birds 251        251 
2.w. Reptiles         0 
2.x. Amphibians         0 
2.y. Fish         0 
2.z. TOTAL 12908 2935 394 573 1704 4236 156 463 23369 
 
EN 108   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami- 
nants in the 
general envi- 
ronment which 
do not appear in 
other columns 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 270 50 120       440 
3.b. Rats 296 121 514   6 75  3 1015 
3.c. Guinea-Pigs 84         84 
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits 66 10 71    9  3 159 
3.g. Cats          0  
3.h. Dogs 6         6 
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle          0  
3.p. Prosimians          0  
3.q. New World Monkeys          0  
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail          0  
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish          0  
3.z. TOTAL 722 181 705 0 0 6 84 0 6 1704 
 
EN 109   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 29 2787 623 8677 1497 13613 
4.b. Rats 1944 1573 181 1792  5490 
4.c. Guinea-Pigs 38   336  374 
4.d. Hamsters      0 
4.e. Other Rodents      0 
4.f. Rabbits  59 8 283  350 
4.g. Cats      0 
4.h. Dogs      0 
4.i. Ferrets      0 
4.j. Other Carnivores      0 
4.k. Horses, donkeys and cross breds      0 
4.l. Pigs      0 
4.m. Goats      0 
4.n. Sheep      0 
4.o. Cattle      0 
4.p. Prosimians      0 
4.q. New World Monkeys      0 
4.r. Old World Monkeys      0 
4.s. Apes      0 
4.t. Other Mammals      0 
4.u. Quail      0 
4.v. Other birds    251  251 
4.w. Reptiles      0 
4.x. Amphibians      0 
4.y. Fish      0 
4.z. TOTAL 2011 4419 812 11339 1497 20078 
 
EN 110   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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  460  77  62 599 
5.b. Rats       0  
5.c. Guinea-Pigs    116   116 
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits  107   5 140 252 
5.g. Cats       0  
5.h. Dogs       0  
5.i. Ferrets       0  
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds       0  
5.l. Pigs       0  
5.m. Goats       0  
5.n. Sheep       0  
5.o. Cattle       0  
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds       0  
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 0 567 0 193 5 202 967 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 111   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Regulatory requirements versus species 
6.1 
Species 6.2  
National legislation 
specific to a single EC 
Member State 
1) 6.3 
EC legislation 
including European 
Pharmacopoeia 
(requirements) 6.4 
Member Country of Council 
of Europe (but not EC) 
legislation 
2) 6.5 
Other legislation 6.6 
Any combination of  
6.2/ 6.3/ 6.4/ 6.5 6.7 
No regulatory 
requirements 6.8 
Total 
6.a. Mice 120 320     440 
6.b. Rats 669 346     1015 
6.c. Guinea-Pigs  84     84 
6.d. Hamsters       0  
6.e. Other Rodents       0  
6.f. Rabbits 89 66 4    159 
6.g. Cats       0  
6.h. Dogs 6      6 
6.i. Ferrets       0  
6.j. Other Carnivores       0  
6.k. Horses, donkeys and cross breds       0  
6.l. Pigs       0  
6.m. Goats       0  
6.n. Sheep       0  
6.o. Cattle       0  
6.p. Prosimians       0  
6.q. New World Monkeys       0  
6.r. Old World Monkeys       0  
6.s. Apes       0  
6.t. Other Mammals       0  
6.u. Quail       0  
6.v. Other birds       0  
6.w. Reptiles       0  
6.x. Amphibians       0  
6.y. Fish       0  
6.z. TOTAL 884 816 4 0 0 0 1704 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 112   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino- 
genicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta- 
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 100 60        160   120 440 
7.b. Rats 6 285 222 218 159  100      25 1015 
7.c. Guinea-Pigs   4  80         84 
7.d. Hamsters              0  
7.e. Other Rodents              0  
7.f. Rabbits   43 16  88       12 159 
7.g. Cats              0  
7.h. Dogs   6           6 
7.i. Ferrets              0  
7.j. Other Carnivores              0  
7.k. Horses, donkeys and cross 
breds              0  
7.l. Pigs              0  
7.m. Goats              0  
7.n. Sheep              0  
7.o. Cattle              0  
7.p. Prosimians              0  
7.q. New World Monkeys              0  
7.r. Old World Monkeys              0  
7.s. Apes              0  
7.t. Other Mammals              0  
7.u. Quail              0  
7.v. Other birds              0  
7.w. Reptiles              0  
7.x. Amphibians              0  
7.y. Fish              0  
7.z. TOTAL 106 345 275 234 239 88 100 0 0 160 0 0 157 1704 
 
EN 113   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine 50 320 89 11 80     160   12 722 
8.b. Products/substances used or intended to 
be used mainly in agriculture 50 25 8 46 14 19       19 181 
8.c. Products/substances used or intended to 
be used mainly in industry   124 147 145 69 100      120 705 
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption 6              6  
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption   54 30          84 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns              0  
8.i. Other toxicological or safety 
evaluations             6  6  
8.j. TOTAL 106 345 275 234 239 88 100 0 0 160 0 0 157 1704 
 
EN 114   ENSWEDEN  
Statistical data submitted 
The statistical data have been submitted by the National Board for Laboratory 
Animals. 
Comments of Swedish authorities  
Additional comments and rem arks 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 wa s in July 2006. Most researchers were 
prompt and submitted their reports in Marc h, 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 electroni cally statistical reporting form that 
will give the researcher a possibility to subm it the statistical record s 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 presen t the statistical r ecords more easily. 
86/609/EEC Directive 
According to the EU definition (direct ive 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 experimenta tion, 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 th e 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 guin ea pigs and rabbits throughout 
the 1990s, this may be due to new tec hniques 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 differe nt reporting categories.  
 
EN 115   EN17%44%39%universities
Pharmaceuticalc
ompanies
Other
authauritiess
 
Specific use of animals 
As in previous years most laboratory an imals were used in either fundamental 
biological research (43%) or in development of product/de vices (17%) used in human 
or veterinary medicine. Du ring 2005, 3% of the animals we re 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 pr oducts/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 labo ratory 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 la rge 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. Af ter discussions with the Swedish Board of 
Fisheries, SAWA decided to include taggi ng 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 fluctuati ons and/or reflect the status of high or low 
economy in Sweden. However, one clear te ndency 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 116   ENincreased throughout the 1990s; this rise is probably due to the increased use of 
transgenic technique(s).  
Swedish definition 
Apart from the information, Sweden also co llects its own statistical data on other use 
of laboratory animals. According to Swedis h legislation all use of animals, which 
have a scientific purpose, should be recorde d. Therefore, this statistical data includes 
all animals used in behaviour studies, feedi ng trials or animals being euthanized for 
the use of their tissues and organs. Du ring 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 w ith nearly 208 000 animals compar ed 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 a nd 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 pe rformed a large feedi ng study with the goal 
of increasing the survival of fi sh released from hatcheries. 
Fish assessment 
Apart from the categories described above, Sw eden 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 animal s in Sweden according to 86/609/EEC 
directive 40% (approx. 505 000) and the Sw edish definition 60% (approx. 767 000) 
60%40%Sw edish
definition
EU Dir ec tiv es
 
Transgenic animals 
The Swedish statistical record s 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 117   ENThe overall impression is that the use of  laboratory animals according to the EU 
directive shows an increase when compari ng 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 fu ll operation during 2005 and of course the 
tagging of fish. During the same period th e Swedish pharmaceutical industries also 
show a slight increase in the use of laboratory animal s (approx: 7000 animals). The 
reason behind these fluctuations difficult sp eculate about it may ju st be a fact of 
natural fluctuations. 
 
EN 118   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from registered 
breeding or supplying 
establishments within the reporting 
country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 213 727 152 004 58 954 0 2 769  
1.b. Rats ( Rattus norvegicus ) 83 321 51 536 31 692 0 93  
1.c. Guinea-Pigs ( Cavia porcellus ) 2 014 1 923 91 0 0  
1.d. Hamsters ( Mesocricetus ) 167 63 104 0 0  
1.e. Other Rodents (other Rodentia ) 1 269      
1.f. Rabbits ( Oryctolagus cuniculus ) 2 112 1 690 422 0 0 28 
1.g. Cats ( Felis catus ) 220 175 0 0 45 0 
1.h. Dogs ( Canis familiaris ) 1 166 1 035 47 0 84 150 
1.i. Ferrets ( Mustela putorius furo ) 47 47 0 0 0 0 
1.j. Other Carnivores (other Carnivora ) 163      
1.k. Horses, donkeys and cross breds ( Equidae ) 650      
1.l. Pigs ( Sus) 2 722      
1.m. Goats ( Capra ) 23      
1.n. Sheep ( Ovis)  256      
1.o. Cattle ( Bos) 727      
1.p. Prosimians ( Prosimia ) 0 0 0 0 0 0 
1.q. New World Monkeys ( Ceboidea ) 12 12 0 0 0 0 
1.r. Old World Monkeys ( Cercopithecoidea ) 63 1 18 0 44 31 
1.s. Apes ( Hominoidea ) 0 0 0 0 0 0 
1.t. Other Mammals (other Mammalia ) 639      
1.u. Quail ( Coturnix coturnix)  0 0 0 0 0  
1.v. Other birds (other Aves ) 7 838      
1.w. Reptiles ( Reptilia ) 0      
1.x. Amphibians ( Amphibia ) 5 496      
1.y. Fish ( Pisces ) 183 049      
1.z. TOTAL 505 681      
Note 1: Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 119   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 152 796 54 941 68 54 2 246 65 1 128 2 429 213 727 
2.b. Rats 47 396 30 220 80 0 4 460 0 943 222 83 321 
2.c. Guinea-Pigs 578 956 443 17 0 0 6 14 2 014 
2.d. Hamsters 53 104 0 0 0 0 10 0 167 
2.e. Other Rodents 401 868 0 0 0 0 0 0 1 269 
2.f. Rabbits 1 053 472 46 2 347 2 35 155 2 112 
2.g. Cats 138 9 0 0 0 51 0 22 220 
2.h. Dogs 370 317 0 0 441 15 3 20 1 166 
2.i. Ferrets 47 0 0 0 0 0 0 0 47 
2.j. Other Carnivores 71 0 0 0 0 0 0 92 163 
2.k. Horses, donkeys and cross 
breds 13 0 0 0 0 7 570 60 650 
2.l. Pigs 1 495 241 0 0 0 260 375 351 2 722 
2.m. Goats 0 0 0 0 0 0 0 23 23 
2.n. Sheep 132 27 0 0 0 0 1 96 256 
2.o. Cattle 315 33 0 0 0 29 340 10 727 
2.p. Prosimians 0 0 0 0 0 0 0 0 0 
2.q. New World Monkeys 0 0 0 0 12 0 0 0 12 
2.r. Old World Monkeys 52 11 0 0 0 0 0 0 63 
2.s. Apes 0 0 0 0 0 0 0 0 0 
2.t. Other Mammals 489 0 0 0 0 0 0 150 639 
2.u. Quail 0 0 0 0 0 0 0 0 0 
2.v. Other birds 5 689 245 15 0 0 0 1 011 878 7 838 
2.w. Reptiles 0 0 0 0 0 0 0 0 0 
2.x. Amphibians 5 419 77 0 0 0 0 0 0 5 496 
2.y. Fish 3 146 0 0 0 8 667 0 577 170 659 183 049 
2.z. TOTAL 219 653 88 521 652 73 16 173 429 4 999 175 181 505 681 
 
EN 120   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami- 
nants in the 
general envi- 
ronment which 
do not appear in 
other columns 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 1 042 0 0 0 0 0 0 159 1 045 2 246 
3.b. Rats 4 460 0 0 0 0 0 0 0 0 4 460 
3.c. Guinea-Pigs          0  
3.d. Hamsters          0  
3.e. Other Rodents          0  
3.f. Rabbits 347 0 0 0 0 0 0 0 0 347 
3.g. Cats          0  
3.h. Dogs 441 0 0 0 0 0 0 0 0 441 
3.i. Ferrets          0  
3.j. Other Carnivores          0  
3.k. Horses, donkeys and cross breds          0  
3.l. Pigs          0  
3.m. Goats          0  
3.n. Sheep          0  
3.o. Cattle          0  
3.p. Prosimians          0  
3.q. New World Monkeys 12 0 0 0 0 0 0 0 0 12 
3.r. Old World Monkeys          0  
3.s. Apes          0  
3.t. Other Mammals          0  
3.u. Quail          0  
3.v. Other birds          0  
3.w. Reptiles          0  
3.x. Amphibians          0  
3.y. Fish 0 300 0 0 0 0 0 8 367 0 8 667 
3.z. TOTAL 6 302 300 0 0 0 0 0 8 526 1 045 16 173 
 
EN 121   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 33 843 27 196 30 212 81 523 19 919 192 693 
4.b. Rats 2 877 6 771 27 216 39 155 0 76 019 
4.c. Guinea-Pigs 0 344 485 760 17 1 606 
4.d. Hamsters 0 66 0 91 0 157 
4.e. Other Rodents 0 77 0 1 192 0 1 269 
4.f. Rabbits 22 373 115 900 2 1 412 
4.g. Cats 0 0 52 0 145 197 
4.h. Dogs 0 128 18 145 392 683 
4.i. Ferrets 0 0 33 14 0 47 
4.j. Other Carnivores 0 0 0 0 0 0 
4.k. Horses, donkeys and cross breds 0 0 0 0 0 0 
4.l. Pigs 0 534 0 978 370 1 882 
4.m. Goats 0 0 0 0 0 0 
4.n. Sheep 17 0 0 40 0 57 
4.o. Cattle 0 10 0 0 358 368 
4.p. Prosimians 0 0 0 0 0 0 
4.q. New World Monkeys 0 0 0 0 0 0 
4.r. Old World Monkeys 0 1 0 56 0 57 
4.s. Apes 0 0 0 0 0 0 
4.t. Other Mammals 0 0 0 0 0 0 
4.u. Quail 0 0 0 0 0 0 
4.v. Other birds 0 0 0 80 545 625 
4.w. Reptiles 0 0 0 0 0 0 
4.x. Amphibians 0 30 87 0 0 117 
4.y. Fish 0 0 0 1 020 1 000 2 020 
4.z. TOTAL 36 759 35 530 58 218 125 954 22 748 279 209 
 
EN 122   EN TABLE 5: NUMBER OF ANIMALS USED IN PRODUCTION AN D QUALITY CONTROL OF PRO DUCTS 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     68 54 122 
5.b. Rats  80     80 
5.c. Guinea-Pigs     406 54 460 
5.d. Hamsters       0  
5.e. Other Rodents       0  
5.f. Rabbits     42 6 48 
5.g. Cats       0  
5.h. Dogs       0  
5.i. Ferrets       0  
5.j. Other Carnivores       0  
5.k. Horses, donkeys and cross breds       0  
5.l. Pigs       0  
5.m. Goats       0  
5.n. Sheep       0  
5.o. Cattle       0  
5.p. Prosimians       0  
5.q. New World Monkeys       0  
5.r. Old World Monkeys       0  
5.s. Apes       0  
5.t. Other Mammals       0  
5.u. Quail       0  
5.v. Other birds      15 15 
5.w. Reptiles       0  
5.x. Amphibians       0  
5.y. Fish       0  
5.z. TOTAL 0 80 0 0 516 129 725 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 123   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 842     1 404 2 246 
6.b. Rats 4 460      4 460 
6.c. Guinea-Pigs        
6.d. Hamsters        
6.e. Other Rodents        
6.f. Rabbits 347      347 
6.g. Cats        
6.h. Dogs 441      441 
6.i. Ferrets        
6.j. Other Carnivores        
6.k. Horses, donkeys and cross breds        
6.l. Pigs        
6.m. Goats        
6.n. Sheep        
6.o. Cattle        
6.p. Prosimians        
6.q. New World Monkeys     12   
6.r. Old World Monkeys        
6.s. Apes        
6.t. Other Mammals        
6.u. Quail        
6.v. Other birds        
6.w. Reptiles        
6.x. Amphibians        
6.y. Fish 7 510     1 157 8 667 
6.z. TOTAL 13 600    12 2 561 16 173 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 124   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino- 
genicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta- 
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a.    462  1 045  35 200  165   339 2 246 
7.b. Rats  265 3 229    113  165 405 51  232 4 460 
7.c. Guinea-Pigs               
7.d. Hamsters               
7.e. Other Rodents               
7.f. Rabbits   36      263  48   347 
7.g. Cats               
7.h. Dogs   383    40      18 441 
7.i. Ferrets               
7.j. Other Carnivores               
7.k. Horses, donkeys and cross 
breds               
7.l. Pigs               
7.m. Goats               
7.n. Sheep               
7.o. Cattle               
7.p. Prosimians               
7.q. New World Monkeys       1 2         
7.r. Old World Monkeys               
7.s. Apes               
7.t. Other Mammals               
7.u. Quail               
7.v. Other birds               
7.w. Reptiles               
7.x. Amphibians               
7.y. Fish         3 570  2 850 2 112 135 8 667 
7.z. TOTAL 0 265 4 110 0 1 045 0 200 200 3 998 570 2 949 2 112 724 16 173 
 
EN 125   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine  265 4 110    165 200 428 446 99  589 6 302 
8.b. Products/substances used or intended to 
be used mainly in agriculture           300   300 
8.c. Products/substances used or intended to 
be used mainly in industry              0  
8.d. Products/substances used or intended to 
be used mainly in the household              0  
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries              0  
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption           1 045   1 045 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption              0  
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns       35  3 570 124 2 550 2 112 135 8 526 
8.i. Other toxicological or safety 
evaluations              0  
8.j. TOTAL 0 265 4 110 0 0 0 200 200 3 998 570 3 994 2 112 724 16 173 
 
EN 126   ENUNITED 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 Br itain (GB) and Northern Ireland (NI) 
publish separate, annual statis tical 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 establis hed practice the UK figures presented here have been 
recompiled from the original data in term s 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 modi fied 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 anim als, 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 sour ced from approved breeders or suppliers 
originated from UK registered breeding or  supplying establishments. Less than 0.5% 
were sourced outside of EC or C ouncil of Europe member countries. 
974,046 animals (52%) were used for fundament al 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 127   ENThere was a marked reduction in the number of animals used to satisfy national 
legislation specific to a single member stat e, with the majority of the animal use 
(72%) being to fulfil multinational regulatory requirements. 
110,384 animals (6%) were used for the prod uction and quality co ntrol 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 b een 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 monoc lonal antibody production using the ascites 
method.
 
EN 128   EN TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN 
Origin versus species 
1.1 
Species 1.2  
Total 1.3 
Animals coming from 
registered breeding or supplying 
establishments within the 
reporting country 1.4 
Animals coming from 
elsewhere in the EC 1.5 
Animals coming from 
Member Countries of the 
Council of Europe which are 
parties to the Convention ETS 
123 (excluding EC Member 
States) 1.6 
Animals coming from 
other origins 1.7 
Re-used animals 
1.a. Mice ( Mus musculus ) 1 052 064 1 048 052 690 40 3 282  
1.b. Rats ( Rattus norvegicus ) 411 501 408 104 1 183 - 2 214  
1.c. Guinea-Pigs ( Cavia porcellus ) 28 918 28 918 - - -  
1.d. Hamsters ( Mesocricetus ) 3 746 2 219 1 256 271 -  
1.e. Other Rodents (other Rodentia ) 8 216      
1.f. Rabbits ( Oryctolagus cuniculus ) 15 523 15 063 410 2 48 2 315  
1.g. Cats ( Felis catus ) 308 205 103 - - 175  
1.h. Dogs ( Canis familiaris ) 5 373 4 294 194 - 885 907  
1.i. Ferrets ( Mustela putorius furo ) 1 004 970 - - 34 18  
1.j. Other Carnivores (other Carnivora ) 938      
1.k. Horses, donkeys and cross breds ( Equidae ) 308      
1.l. Pigs ( Sus) 4 127      
1.m. Goats ( Capra ) 274      
1.n. Sheep ( Ovis)  11 772      
1.o. Cattle ( Bos) 6 306      
1.p. Prosimians ( Prosimia ) - - - - - -  
1.q. New World Monkeys ( Ceboidea ) 643 501 108 34 - 148  
1.r. Old World Monkeys ( Cercopithecoidea ) 2 472 135 6 - 2 331 590  
1.s. Apes ( Hominoidea ) - - - - - -  
1.t. Other Mammals(other Mammalia ) 2 541      
1.u. Quail ( Coturnix coturnix)  140 140 - - -  
1.v. Other birds (other Aves ) 114 860      
1.w. Reptiles ( Reptilia ) 84      
1.x. Amphibians ( Amphibia ) 10 585      
1.y. Fish ( Pisces ) 192 504      
1.z. TOTAL 1 874 207      
Note 1: Column 1.5 concerns only those Member Countries of the Co uncil of Europe which, at the beginning of the reporting perio d, 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 b oxes 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 129   EN 
 
EN 130   EN TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES 
Purpose versus species 
2.1 
Species 2.2  
Biological 
studies of a 
fundamenta
l nature 2.3 
Research and 
development of 
products and 
devices for human 
medicine and 
dentistry and for 
veterinary 
medicine 
(excluding 
toxicological and 
other safety 
evaluations 
counted in column 
2.6) 2.4 
Production and 
quality control of 
products and 
devices for 
human medicine 
and dentistry 2.5 
Production and 
quality control of 
products and 
devices for 
veterinary 
medicine 2.6 
Toxicological 
and other safety 
evaluations 
(including 
safety 
evaluation of 
products and 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine) 2.7 
Diagnosis of 
disease 2.8 
Education and 
training 2.9 
Other 2.10 
Total 
2.a. Mice 55 660  92 488 63 461 18 280 81 113 8 016 896 432 150 1 052 064  
2.b. Rats 115 092  143 212 4 061 - 110 005 10 1 427 37 694 411 501  
2.c. Guinea-Pigs 3 235  11 578 7 396 1 273 2 890 448 118 1 980 28 918  
2.d. Hamsters 1 656  30 60 480 1 304 - - 216 3 746  
2.e. Other Rodents 5 266  2 794 -  -  40 - 2 114 8 216  
2.f. Rabbits 1 488  768 338 990 8 456 1 737 32 1 714 15 523  
2.g. Cats 237  71 - - - - - -  308  
2.h. Dogs 119  748 4 - 4 248 15 - 39 5 373  
2.i. Ferrets 172  94 6 - - 35 13 684 1 004  
2.j. Other Carnivores 502  - - - - - - 436 938  
2.k. Horses, donkeys and cross 
breds 38  31 - 50 25 68 8 88 308  
2.l. Pigs 2 046  445 36 716 541 - - 343 4 127  
2.m. Goats 233  6 - - 3 11 - 21 274  
2.n. Sheep 5 681  136 -  169  223 408 5 5 150 11 772  
2.o. Cattle 4 312  523 -  718  345 9 - 399 6 306  
2.p. Prosimians -  - - - - - - - -  
2.q. New World Monkeys 114  86 8 - 334 16 - 85 643  
2.r. Old World Monkeys 89  110 - - 2 257  - 16 2 472  
2.s. Apes -  - - - - - - - -  
2.t. Other Mammals 1 937  - - - 15 - - 589 2 541  
2.u. Quail 140  - - - -  - - - 140  
2.v. Other birds 29 119  687 - 5 746 4 000 2 470 6 72 832 114 860  
2.w. Reptiles  70  - - -  12  - - 2 84  
2.x. Amphibians 8 943  - - - -  - - 1 642 10 585  
2.y. Fish 106 445  2 275 - 6 592 32 799 163 - 44 230 192 504  
 
EN 131   EN 2.z. TOTAL 642 594  256 082 75 370 35 014 248 610 13 406 2 507 600624 1 874 207  
 
EN 132   EN TABLE 3: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Products versus species 
3.1 
Species 3.2  
Products/ 
substances or 
devices for 
human 
medicine and 
dentistry and 
for veterinary 
medicine 3.3 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
agriculture 3.4 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
industry 3.5 
Products/ 
substances 
used or 
intended to 
be used 
mainly in 
the 
household 3.6 
Products/ 
substances 
used or 
intended to 
be used 
mainly as 
cosmetics 
or toiletries 3.7 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
human 
consumption 3.8 
Products/ 
substances 
used or 
intended to be 
used mainly 
as additives in 
food for 
animal 
consumption 3.9 
Potential or 
actual contami- 
nants in the 
general envi- 
ronment which 
do not appear in 
other columns 3.10 
Other toxico- 
logical or 
safety 
evaluations 3.11 
Total 
3.a. Mice 49965 3335 6955 21 - - - 3 20834 81113 
3.b. Rats 70890 18134 10621 - - - - 324 10036 110005 
3.c. Guinea-Pigs 2366 120 128 - - - - - 276 2890 
3.d. Hamsters 721 551 16 - - - - - 16 1304 
3.e. Other Rodents - 40 - - - - - - - 40 
3.f. Rabbits 5378 1120 1742 - - - - - 216 8456 
3.g. Cats - - - - - - - - - - 
3.h. Dogs 4012 91 3 - - - - - 142 4248 
3.i. Ferrets - - - - - - - - - - 
3.j. Other Carnivores - - - - - - - - - - 
3.k. Horses, donkeys and cross breds 25 - - - - - - - - 25 
3.l. Pigs 409 90 - - - - - - 42 541 
3.m. Goats - 3 - - - - - - - 3 
3.n. Sheep 213 10 - - - - - - - 223 
3.o. Cattle 297 48 - - - - - - - 345 
3.p. Prosimians - - - - - - - - - - 
3.q. New World Monkeys 297 - - - - - - - 37 334 
3.r. Old World Monkeys 1961 - - - - - - - 296 2257 
3.s. Apes - - - - - - - - - - 
3.t. Other Mammals 15 - - - - - - - - 15 
3.u. Quail - - - - - - - - - - 
3.v. Other birds 1240 2620 - - - - - 131 9 4000 
3.w. Reptiles - - - - - - - - 12 12 
3.x. Amphibians - - - - - - - - - - 
3.y. Fish 3326 6579 4398 - - - - 16109 2387 32799 
3.z. TOTAL 141115 32741 23863 21 - - - 16567 34303 248610 
 
EN 133   EN TABLE 4: NUMBER OF ANIMALS USED IN EXPERIME NTS FOR STUDIES ON HUM AN AND ANIMAL DISEASES 
Main categories versus species 
4.1 
Species 4.2  
Human cardiovascular 
diseases 4.3 
Human nervous and 
mental disorders 4.4 
Human cancer (excluding 
evaluations of carcinogenic 
hazards or risks) 4.5 
Other human diseases 4.6 
Studies specific to animal 
diseases 4.7 
Total 
4.a. Mice 22260 99729 86802 459327 22392 690510 
4.b. Rats 16176 145474 5694 187929 1464 356737 
4.c. Guinea-Pigs 975 1884 - 23963 1564 28386 
4.d. Hamsters - 740 76 1707 639 3162 
4.e. Other Rodents 38 4517 85 3470 - 8110 
4.f. Rabbits 1005 99 63 9944 1337 12448 
4.g. Cats - 98 - 139 71 308 
4.h. Dogs 466 3 10 4502 280 5261 
4.i. Ferrets 102 140 - 749 - 991 
4.j. Other Carnivores 2 - - 500 403 905 
4.k. Horses, donkeys and cross breds - 12 - 94 192 298 
4.l. Pigs 278 62 - 2205 1543 4088 
4.m. Goats 31 - - 232 8 271 
4.n. Sheep 116 474 - 6244 4864 11698 
4.o. Cattle 135 1788 - 2398 1914 6235 
4.p. Prosimians - - - - - - 
4.q. New World Monkeys 33 50 - 547 - 630 
4.r. Old World Monkeys 41 76 - 2097 - 2214 
4.s. Apes - - - - - - 
4.t. Other Mammals 240 182 - 1697 15 2134 
4.u. Quail - 140 - - - 140 
4.v. Other birds 1377 5456 - 25010 80509 112352 
4.w. Reptiles - 70 - 12 - 82 
4.x. Amphibians 472 53 745 7673 - 8943 
4.y. Fish - 3282 - 105746 25538 134566 
4.z. TOTAL 43747 264329 93475 846185 142733 1390469 
 
EN 134   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 1924 6000 - 136 66574 7107 81741 
5.b. Rats - 1920 - - 567 1574 4061 
5.c. Guinea-Pigs 5711 1399 - 122 1137 300 8669 
5.d. Hamsters - 480 - - - 60 540 
5.e. Other Rodents - - - - - - - 
5.f. Rabbits 116 - - - 1202 10 1328 
5.g. Cats - - - - - - - 
5.h. Dogs - - - - - 4 4 
5.i. Ferrets - - - - - 6 6 
5.j. Other Carnivores - - - - - - - 
5.k. Horses, donkeys and cross breds - - - - 50 - 50 
5.l. Pigs 24 716 - - - 12 752 
5.m. Goats - - - - - - - 
5.n. Sheep - 98 - - 71 - 169 
5.o. Cattle 49 265 - - 352 52 718 
5.p. Prosimians - - - - - - - 
5.q. New World Monkeys - - - - - 8 8 
5.r. Old World Monkeys - - - - - - - 
5.s. Apes - - - - - - - 
5.t. Other Mammals - - - - - - - 
5.u. Quail - - - - - - - 
5.v. Other birds - 68 - - 5185 493 5746 
5.w. Reptiles - - - - - - - 
5.x. Amphibians - - - - - - - 
5.y. Fish - 2621 - - 3971 - 6592 
5.z. TOTAL 7824 13567 - 258 79109 9626 110384 
Examples: 5.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 5.2 - 5. 5 refer to the legislation imp osing that the test be carried out and 
 5.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 5.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 5.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 5.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 5.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 
EN 135   EN  2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenstein, Lithuania, 
Malta, Moldova, Norway, Poland, Romania, Ru ssia, San Marino, Slovakia, Slovenia, Switz erland, ‘the former Yugoslav Rep. of Mace donia’, Turkey, Ukraine 
 
EN 136   EN TABLE 6: NUMBER OF ANIMALS USED IN TOXI COLOGICAL 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 566 8683 - 1921 57004 12939 81113 
6.b. Rats 1000 3862 - 3869 92289 8985 110005 
6.c. Guinea-Pigs 4 165 - 256 2076 389 2890 
6.d. Hamsters - - - - 1022 282 1304 
6.e. Other Rodents - - - - - 40 40 
6.f. Rabbits 29 2114 - 539 5662 112 8456 
6.g. Cats - - - - - - - 
6.h. Dogs - 24 - - 4051 173 4248 
6.i. Ferrets - - - - - - - 
6.j. Other Carnivores - - - - - - - 
6.k. Horses, donkeys and cross breds - - - - 25 - 25 
6.l. Pigs - 181 - - 305 55 541 
6.m. Goats - - - - 3 - 3 
6.n. Sheep - 36 - - 181 6 223 
6.o. Cattle 4 151 - - 178 12 345 
6.p. Prosimians - - - - - - - 
6.q. New World Monkeys - - - - 297 37 334 
6.r. Old World Monkeys - - - - 2207 50 2257 
6.s. Apes - - - - - - - 
6.t. Other Mammals - 15 - - - - 15 
6.u. Quail - - - - - - - 
6.v. Other birds 50 950 - 522 2306 172 4000 
6.w. Reptiles 12 - - - - - 12 
6.x. Amphibians - - - - - - - 
6.y. Fish 3581 7148 - 1144 15110 5816 32799 
6.z. TOTAL 5246 23329 - 8251 182716 29068 248610 
Examples: 6.2 – France is testing due to a UK (or FR) specific  requirement Note: columns 6.2 - 6. 5 refer to the legislation imp osing that the test be carried out and 
 6.3 - UK is testing according to EC legislation  not to the bo dy which has issued the actual te st method, guidel ine or protoco l. 
 6.4 – Spain is testing due to a Hungarian requirement Example: a test required by French legislation and carried out in Belgiu m according to an 
 6.5 – Sweden is testing due to a US specific requirement  ISO protocol must be coded as a national (FR) legislative requiremen t and be 
 6.6 – Germany is testing due to  a Czech requirement (also an EC 
requirement)  entered into column 6.2 in the tables submitted by Belgium. 
Footnotes: 1) EC Member States: Austria, Belgium, Denmark, Finl and, France, Germany, Greece, Ir eland, Italy, Luxembourg, Nether lands, Portugal, Spain, Sw eden, United Kingdom 
 2) Member Countries of Council of Europe (non-EC): Albania, A ndorra, Bulgaria, Croatia, Cyprus, Czech Rep., Estonia, Hungary, Iceland, Latvia, Liechtenst ein, Lithuania, Malta, 
Moldova, Norway, Poland, Romania, Russia, San Marino, Slovakia, Slovenia, Switzerland,  ‘the former Yugoslav Rep. of Macedonia’,  Turkey, Ukraine 
 
EN 137   EN TABLE 7: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus species 
7.1 
Species 7.2 
Acute and sub-acute toxicity testing methods 
(including limit test) 
 7.3 
Skin 
irritation 7.4 
Skin 
sensitisatio
n 7.5 
Eye 
irritation 7.6 
Sub- 
chronic and 
chronic 
toxicity 7.7 
Carcino- 
genicity 7.8 
Develop- 
mental 
toxicity 7.9 
Muta- 
genicit
y 7.10 
Repro-
ductive 
toxicity 7.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 7.12 
Other 7.13 
Total 
  7.2.1. 
LD50, 
LC50 7.2.2 
Other lethal 
methods 7.2.3 
Non lethal 
clinical signs 
methods            
7.a. Mice 6784 384 7497 6 2496 - 4424 7549 769 3247 - - 47957 81113 
7.b. Rats 3636 2309 30789 - - - 11778 8654 4556 5565 25216 - 17502 110005 
7.c. Guinea-Pigs 217 - 86 12 278 - - - - - - - 2297 2890 
7.d. Hamsters - - 482 - - - - - - - - - 822 1304 
7.e. Other Rodents - - - - - - - - - - - - 40 40 
7.f. Rabbits - 12 532 1302 - 837 244 - 3141 - 123 - 2265 8456 
7.g. Cats - - - - - - - - - - - - - - 
7.h. Dogs - - 2279 - - - 1541 - - - - - 428 4248 
7.i. Ferrets - - - - - - - - - - - - - - 
7.j. Other Carnivores - - - - - - - - - - - - - - 
7.k. Horses, donkeys and cross 
breds - - - - - - - - - - - - 25 25 
7.l. Pigs - - 52 - - - - - - - - - 489 541 
7.m. Goats - - - - - - - - - - - - 3 3 
7.n. Sheep - - 24 - - - - - - - - - 199 223 
7.o. Cattle - - 39 - - - - - - - - - 306 345 
7.p. Prosimians - - - - - - - - - - - - - - 
7.q. New World Monkeys - 13 112 - - - 155 - - - - - 54 334 
7.r. Old World Monkeys - - 1035 - - - 838 - - - - - 384 2257 
7.s. Apes - - - - - - - - - - - - - - 
7.t. Other Mammals - - - - - - - - - - - - 15 15 
7.u. Quail - - - - - - - - - - - - - - 
7.v. Other birds 920 140 400 - - - - - - - - - 2540 4000 
7.w. Reptiles - - - - - - - - - - - - 12 12 
7.x. Amphibians - - - - - - - - - - - - - - 
7.y. Fish 9192 7157 6963 - - - 752 - - 226 710 - 7799 32799 
7.z. TOTAL 20749 10015 50290 1320 2774 837 19732 16203 8466 9038 26049 - 83137 248610 
 
EN 138   EN TABLE 8: NUMBER OF ANIMALS USED IN TOXI COLOGICAL AND OTHER SAFETY EVALUATIONS 
Types of tests versus products 
8.1 
Products 8.2 
Acute and sub-acute toxicity testing 
methods (including limit test) 
 8.3 
Skin 
irritation 8.4 
Skin 
sensitisatio
n 8.5 
Eye 
irritation 8.6 
Sub- 
chronic 
and 
chronic 
toxicity 8.7 
Carcino 
genicity 8.8 
Develop- 
mental 
toxicity 8.9 
Muta- 
genicit
y 8.10 
Repro-
ductive 
toxicity 8.11 
Toxicity 
to aquatic 
vertebra-
tes not 
included 
in other 
columns 8.12 
Other 8.13 
Total 
  8.2.1. 
LD50, 
LC50 8.2.2 
Other lethal 
methods 8.2.3 
Non lethal 
clinical signs 
methods            
8.a. Products/substances or devices for 
human medicine and dentistry and for 
veterinary medicine - 383 32535 103 428 18 16045 14662 7260 5558 14797 - 49326 141115 
8.b. Products/substances used or intended to 
be used mainly in agriculture 3213 2703 7461 280 365 240 2214 1377 832 839 7915 - 5302 32741 
8.c. Products/substances used or intended to 
be used mainly in industry 2288 1824 7050 937 1775 579 577 60 264 1720 2357 - 4432 23863 
8.d. Products/substances used or intended to 
be used mainly in the household - - - - 21 - - - - - - - - 21 
8.e. Products/substances used or intended to 
be used mainly as cosmetics or 
toiletries - - - - - - - - - - - - - - 
8.f. Products/substances used or intended to 
be used mainly as additives in food for 
human consumption - - - - - - - - - - - - - - 
8.g. Products/substances used or intended to 
be used mainly as additives in food for 
animal consumption - - - - - - - - - - - - - - 
8.h. Potential or actual contaminants in the 
general environment which do not 
appear in other columns 4268 3927 2504 - - - - - - 226 980 - 4662 16567 
8.i. Other toxicological or safety 
evaluations 10980 1178 740 - 185 - 896 104 110 695 - - 19415 34303 
8.j. TOTAL 20749 10015 50290 1320 2774 837 19732 16203 8466 9038 26049 - 83137 248610