Source: EURLEX
Language: en
Format: md

EN

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|  | EUROPEAN COMMISSION |

Brussels, 30.9.2010

SEC(2010) 1107 final

VOL B - Part II ([I], [III])

COMMISSION STAFF WORKING DOCUMENT

DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
  

  
Accompanying document to the
  
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
  

  
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

COM(2010) 511 final

Important notice

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

VOL B - Part II: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

TABLE OF CONTENTS

FRANCE
   5

ITALY
   14

CYPRUS
   23

LATVIA
   28

LITHUANIA
   35

LUXEMBOURG
   35

HUNGARY
   35

MALTA
   35

THE NETHERLANDS
   35

FRANCE

Statistical data submitted

The statistical data have been submitted by the “Ministère de la Recherche et des Nouvelles Technologies” (Ministry for Research and New Technologies).

Comments of the French authorities

This study was realized by the EFICOM Markétudes Company for the Research and Higher Education Ministry.

The number of animals used in France shows a steady state since 1999 with about 2.5 million. It represents a decrease of 30% in comparison with the figures of the first statistical study in 1990. In 2007, a slight increasing tendency could be observed which led to values similar to the 1997 figures. Since 1999, the amount of rodents used is stable (2.1 million). Even if some animal groups are more often used (the number of birds and rabbits has doubled and the number of fish has increased by 37%), there is a reverse tendency for other species (the amount of dogs has decreased by 15%). The use of non human primates is steady from 1999, probably because of their incompressible scientific interests.

Concerning the results of the survey, when significant differences were revealed between 2007 and previous years, some verification was done in order to identify the origin of these sudden evolutions. These differences could always be explained by: either new activity, for example the production of therapeutic antibodies giving an explanation to rabbits increase observed since 2004, or the opening or the closure of laboratories. The other variations were not significant and supported the figures provided by experimental centres and laboratories.

This study showed that the public sector used half (47%) of the total amount of animals, of which 80% is for basic research and education. On the other hand, the private sector used the remaining 53%, of which 40% are dedicated to research and development, 37% to production and control, and 6% to toxicological evaluations.

Similar to the numbers observed in 2004, the present study shows that there are about 450 centres for animal experimentation (this number can vary depending on juridical conventions that link laboratories to these centres).

It represents a third of the figure established in 1990. This decrease in the number of experimental centres shows that laboratories are merged or clustered in order to share centralized installations and competent staff. The « disappearance » of 900 experimental animal houses shows the pressure brought by the animal protection associations and the concerned authorities for fifteen years. It was supported by very significant investments to come up to the current sanitary, ethic and scientific expectations. Of course, this diminution did not obviously result in a proportional decrease of the number of animals, but it sets practices that warrant respect and well-being to animals.

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) | 1.561.809 | 1.423.488 | 47.564 | 2.534 | 88.223 |  |
| 1.b. | Rats (Rattus norvegicus) | 392.773 | 367.102 | 16.411 | 10 | 9.250 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 46.030 | 41.952 | 3.895 | 0 | 183 |  |
| 1.d. | Hamsters (Mesocricetus ) | 12.063 | 10.271 | 959 | 0 | 833 |  |
| 1.e. | Other Rodents (other Rodentia) | 3.594 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 96.427 | 96.169 | 5 | 0 | 253 | 430 |
| 1.g. | Cats (Felis catus) | 1.848 | 1.391 | 245 | 3 | 209 | 644 |
| 1.h. | Dogs (Canis familiaris) | 4.131 | 2.928 | 262 | 0 | 941 | 805 |
| 1.i. | Ferrets (Mustela putorius furo) | 800 | 591 | 0 | 0 | 209 | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 0 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 652 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 8.768 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 1.159 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 3.573 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 3.206 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 718 | 718 | 0 | 0 | 0 | 33 |
| 1.q. | New World Monkeys (Ceboidea) | 233 | 213 | 20 | 0 | 0 | 135 |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 1.797 | 610 | 262 | 0 | 925 | 244 |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. | Other Mammals (other Mammalia) | 0 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 1.548 | 48 | 1.500 | 0 | 0 |  |
| 1.v. | Other birds (other Aves) | 156.814 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 758 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 9.451 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 20.228 |  |  |  |  |  |
| 1.z. | TOTAL | 2.328.380 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 585.129 | 429.558 | 279.987 | 45.522 | 50.866 | 12.308 | 18.947 | 139.492 | 1.561.809 |
| 2.b. | Rats | 80.421 | 182.333 | 5.161 | 13.121 | 47.447 | 697 | 14.196 | 49.397 | 392.773 |
| 2.c. | Guinea-Pigs | 739 | 3.705 | 30.748 | 2.230 | 7.317 | 2 | 274 | 1.015 | 46.030 |
| 2.d. | Hamsters | 1.590 | 2.618 | 0 | 6.414 | 21 | 10 | 4 | 1.406 | 12.063 |
| 2.e. | Other Rodents | 941 | 1.690 | 0 | 0 | 0 | 0 | 918 | 45 | 3.594 |
| 2.f. | Rabbits | 3.348 | 6.202 | 50.152 | 7.147 | 7.737 | 125 | 799 | 20.917 | 96.427 |
| 2.g. | Cats | 138 | 790 | 0 | 544 | 24 | 0 | 3 | 349 | 1.848 |
| 2.h. | Dogs | 354 | 1.072 | 0 | 732 | 1.834 | 0 | 8 | 131 | 4.131 |
| 2.i. | Ferrets | 0 | 162 | 8 | 0 | 237 | 0 | 13 | 380 | 800 |
| 2.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.k. | Horses, donkeys and cross breds | 196 | 139 | 83 | 20 | 0 | 0 | 75 | 139 | 652 |
| 2.l. | Pigs | 470 | 2.860 | 0 | 2.545 | 434 | 23 | 241 | 2.195 | 8.768 |
| 2.m. | Goats | 330 | 41 | 3 | 19 | 29 | 0 | 18 | 719 | 1.159 |
| 2.n. | Sheep | 1.331 | 638 | 27 | 655 | 205 | 0 | 56 | 661 | 3.573 |
| 2.o. | Cattle | 310 | 541 | 0 | 298 | 84 | 140 | 30 | 1.803 | 3.206 |
| 2.p. | Prosimians | 568 | 0 | 0 | 0 | 0 | 150 | 0 | 0 | 718 |
| 2.q. | New World Monkeys | 63 | 77 | 0 | 0 | 0 | 0 | 0 | 93 | 233 |
| 2.r. | Old World Monkeys | 184 | 198 | 139 | 0 | 1.128 | 0 | 0 | 148 | 1.797 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 1.548 | 0 | 1.548 |
| 2.v. | Other birds | 2.821 | 7.491 | 9.280 | 86.122 | 5.251 | 1.400 | 6.593 | 37.856 | 156.814 |
| 2.w. | Reptiles | 758 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 758 |
| 2.x. | Amphibians | 5.013 | 52 | 0 | 0 | 179 | 0 | 4.207 | 0 | 9.451 |
| 2.y. | Fish | 5.836 | 200 | 0 | 0 | 2.954 | 0 | 7.643 | 3.595 | 20.228 |
| 2.z. | TOTAL | 690.540 | 640.367 | 375.588 | 165.369 | 125.747 | 14.855 | 55.573 | 260.341 | 2.328.380 |

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 23.187 | 3.441 | 2.074 | 0 | 704 | 0 | 0 | 3.776 | 17.684 | 50.866 |
| 3.b. | Rats | 26.440 | 6.006 | 3.375 | 159 | 0 | 0 | 0 | 1.499 | 9.968 | 47.447 |
| 3.c. | Guinea-Pigs | 4.468 | 608 | 1.755 | 0 | 38 | 0 | 0 | 0 | 448 | 7.317 |
| 3.d. | Hamsters | 0 | 0 | 21 | 0 | 0 | 0 | 0 | 0 | 0 | 21 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 5.247 | 563 | 481 | 0 | 43 | 0 | 0 | 0 | 1.403 | 7.737 |
| 3.g. | Cats | 24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 |
| 3.h. | Dogs | 1.160 | 104 | 0 | 0 | 0 | 0 | 0 | 0 | 570 | 1.834 |
| 3.i. | Ferrets | 237 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 237 |
| 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 | 404 | 0 | 0 | 0 | 0 | 0 | 0 | 30 | 0 | 434 |
| 3.m. | Goats | 21 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 29 |
| 3.n. | Sheep | 205 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 205 |
| 3.o. | Cattle | 84 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 84 |
| 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 | 930 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 198 | 1.128 |
| 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 | 25 | 0 | 0 | 0 | 0 | 0 | 5.000 | 0 | 226 | 5.251 |
| 3.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.x. | Amphibians | 179 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 179 |
| 3.y. | Fish | 0 | 1.457 | 0 | 0 | 300 | 0 | 0 | 1.047 | 150 | 2.954 |
| 3.z. | TOTAL | 62.611 | 12.179 | 7.706 | 159 | 1.085 | 0 | 5.000 | 6.360 | 30.647 | 125.747 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 60.574 | 232.877 | 180.979 | 333.623 | 218.942 | 1.026.995 |
| 4.b. | Rats | 45.947 | 84.717 | 15.812 | 106.175 | 10.800 | 263.451 |
| 4.c. | Guinea-Pigs | 479 | 312 | 190 | 2.639 | 826 | 4.446 |
| 4.d. | Hamsters | 434 | 708 | 0 | 1.042 | 2.034 | 4.218 |
| 4.e. | Other Rodents | 300 | 1.774 | 60 | 191 | 306 | 2.631 |
| 4.f. | Rabbits | 1.197 | 2 | 123 | 6.710 | 1.643 | 9.675 |
| 4.g. | Cats | 0 | 31 | 0 | 60 | 837 | 928 |
| 4.h. | Dogs | 114 | 133 | 13 | 499 | 667 | 1.426 |
| 4.i. | Ferrets | 0 | 0 | 0 | 162 | 0 | 162 |
| 4.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 335 | 335 |
| 4.l. | Pigs | 736 | 0 | 0 | 547 | 2.070 | 3.353 |
| 4.m. | Goats | 0 | 10 | 0 | 6 | 355 | 371 |
| 4.n. | Sheep | 140 | 62 | 0 | 97 | 1.670 | 1.969 |
| 4.o. | Cattle | 0 | 0 | 0 | 0 | 991 | 991 |
| 4.p. | Prosimians | 0 | 40 | 0 | 308 | 370 | 718 |
| 4.q. | New World Monkeys | 0 | 4 | 0 | 115 | 21 | 140 |
| 4.r. | Old World Monkeys | 0 | 20 | 0 | 362 | 0 | 382 |
| 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 | 120 | 0 | 0 | 11.592 | 11.712 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 758 | 758 |
| 4.x. | Amphibians | 0 | 52 | 2.399 | 658 | 1.956 | 5.065 |
| 4.y. | Fish | 900 | 250 | 0 | 930 | 3.956 | 6.036 |
| 4.z. | TOTAL | 110.821 | 321.112 | 199.576 | 454.124 | 260.129 | 1.345.762 |

  

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 | | | 2.709 | 71.121 | 371 | | 407 | 244.482 | 6.419 | 325.509 |
| 5.b. | Rats | | | 4.053 | 194 | 405 | | 12.732 | 383 | 515 | 18.282 |
| 5.c. | Guinea-Pigs | | | 0 | 5.042 | 0 | | 32 | 27.904 | 0 | 32.978 |
| 5.d. | Hamsters | | | 0 | 6.414 | 0 | | 0 | 0 | 0 | 6.414 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 10 | 37.019 | 0 | | 0 | 3.859 | 16.411 | 57.299 |
| 5.g. | Cats | | | 0 | 536 | 0 | | 8 | 0 | 0 | 544 |
| 5.h. | Dogs | | | 0 | 732 | 0 | | 0 | 0 | 0 | 732 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 8 | 0 | 8 |
| 5.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 20 | 0 | | 0 | 83 | 0 | 103 |
| 5.l. | Pigs | | | 0 | 2.454 | 0 | | 91 | 0 | 0 | 2.545 |
| 5.m. | Goats | | | 19 | 0 | 0 | | 0 | 3 | 0 | 22 |
| 5.n. | Sheep | | | 189 | 466 | 0 | | 0 | 27 | 0 | 682 |
| 5.o. | Cattle | | | 0 | 298 | 0 | | 0 | 0 | 0 | 298 |
| 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 | 139 | 0 | 139 |
| 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 | | | 0 | 86.034 | 0 | | 80 | 9.280 | 8 | 95.402 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 6.980 | 210.330 | 776 | | 13.350 | 286.168 | 23.353 | 540.957 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 6.960 | 13.193 | 658 | | 2.783 | 20.930 | 6.342 | 50.866 |
| 6.b. | Rats | | | 8.250 | 5.748 | 79 | | 9.219 | 20.712 | 3.439 | 47.447 |
| 6.c. | Guinea-Pigs | | | 286 | 2.516 | 0 | | 0 | 4.515 | 0 | 7.317 |
| 6.d. | Hamsters | | | 21 | 0 | 0 | | 0 | 0 | 0 | 21 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 260 | 1.314 | 0 | | 1.405 | 4.734 | 24 | 7.737 |
| 6.g. | Cats | | | 0 | 24 | 0 | | 0 | 0 | 0 | 24 |
| 6.h. | Dogs | | | 53 | 191 | 0 | | 723 | 867 | 0 | 1.834 |
| 6.i. | Ferrets | | | 211 | 0 | 0 | | 26 | 0 | 0 | 237 |
| 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 | | | 55 | 18 | 0 | | 149 | 212 | 0 | 434 |
| 6.m. | Goats | | | 29 | 0 | 0 | | 0 | 0 | 0 | 29 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 205 | 0 | 205 |
| 6.o. | Cattle | | | 0 | 84 | 0 | | 0 | 0 | 0 | 84 |
| 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 | 190 | 0 | | 732 | 198 | 8 | 1.128 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 0 | 25 | 0 | | 5.000 | 0 | 226 | 5.251 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 179 | 0 | 179 |
| 6.y. | Fish | | | 82 | 0 | 0 | | 0 | 1.457 | 1.415 | 2.954 |
| 6.z. | TOTAL | | | 16.207 | 23.303 | 737 | | 20.037 | 54.009 | 11.454 | 125.747 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 1.455 | 7.107 | 9.877 | 648 | 1.733 | 0 | 12.298 | 2.524 | 730 | 139 | 0 | 0 | 14.355 | 50.866 |
| 7.b. | Rats | 36 | 1.169 | 5.128 | 12 | 1.290 | 78 | 16.839 | 5.287 | 2.075 | 1.547 | 4.489 | 0 | 9.497 | 47.447 |
| 7.c. | Guinea-Pigs | 0 | 0 | 36 | 0 | 6.584 | 0 | 0 | 0 | 0 | 0 | 86 | 0 | 611 | 7.317 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 21 | 0 | 0 | 0 | 21 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 0 | 0 | 349 | 1.059 | 0 | 377 | 568 | 0 | 669 | 0 | 965 | 0 | 3.750 | 7.737 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 | 24 |
| 7.h. | Dogs | 0 | 0 | 461 | 0 | 0 | 0 | 1.106 | 0 | 0 | 0 | 18 | 0 | 249 | 1.834 |
| 7.i. | Ferrets | 0 | 0 | 211 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 26 | 237 |
| 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 | 84 | 0 | 294 | 434 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 29 | 29 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 205 | 205 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 84 | 84 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 80 | 0 | 0 | 0 | 864 | 0 | 0 | 0 | 0 | 0 | 184 | 1.128 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5.251 | 5.251 |
| 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 | 179 | 179 |
| 7.y. | Fish | 1.907 | 0 | 0 | 0 | 0 | 0 | 890 | 0 | 0 | 0 | 0 | 82 | 75 | 2.954 |
| 7.z. | TOTAL | 3.398 | 8.276 | 16.142 | 1.719 | 9.607 | 455 | 32.621 | 7.811 | 3.474 | 1.707 | 5.642 | 82 | 34.813 | 125.747 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 1.965 | 5.233 | 9.654 | 638 | 4.460 | 170 | 14.646 | 3.293 | 1.141 | 1.480 | 5.211 | 0 | 14.720 | 62.611 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 1.430 | 310 | 0 | 100 | 608 | 88 | 5.944 | 2.682 | 867 | 0 | 150 | 0 | 0 | 12.179 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 0 | 1.378 | 665 | 942 | 1.673 | 182 | 230 | 246 | 626 | 101 | 60 | 0 | 1.603 | 7.706 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 0 | 0 | 0 | 0 | 0 | 0 | 159 | 0 | 0 | 0 | 0 | 0 | 0 | 159 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 300 | 0 | 43 | 39 | 699 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.085 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5.000 | 5.000 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 0 | 2.600 | 0 | 0 | 0 | 0 | 2.014 | 0 | 0 | 890 | 327 | 82 | 447 | 6.360 |
| 8.i. | Other toxicological or safety evaluations | 221 | 3.397 | 589 | 0 | 0 | 6 | 3.792 | 2.604 | 300 | 0 | 1.902 | 0 | 17.836 | 30.647 |
| 8.j. | TOTAL | 3.916 | 12.918 | 10.951 | 1.719 | 7.440 | 450 | 26.785 | 8.825 | 2.934 | 2.471 | 7.650 | 82 | 39.606 | 125.747 |

ITALY

Statistical data submitted

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

Comments of the Italian authorities

None

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) | 553000 | 528861 | 12593 | 223 | 11323 |  |
| 1.b. | Rats (Rattus norvegicus) | 230347 | 224605 | 5077 | 0 | 665 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 13875 | 9924 | 3951 | 0 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 717 | 604 | 36 | 0 | 77 |  |
| 1.e. | Other Rodents (other Rodentia) | 1235 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 9706 | 9061 | 645 | 0 | 0 | 603 |
| 1.g. | Cats (Felis catus) | 26 | 0 | 0 | 0 | 26 | 0 |
| 1.h. | Dogs (Canis familiaris) | 943 | 720 | 70 | 0 | 153 | 52 |
| 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) | 46 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 3607 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 41 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 469 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 462 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.q. | New World Monkeys (Ceboidea) | 18 | 11 | 7 | 0 | 0 | 53 |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 344 | 182 | 107 | 2 | 53 | 72 |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. | Other Mammals (other Mammalia) | 151 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 249 | 4 | 0 | 0 | 245 |  |
| 1.v. | Other birds (other Aves) | 32241 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 454 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 2432 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 13955 |  |  |  |  |  |
| 1.z. | TOTAL | 864318 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 311807 | 143156 | 26423 | 2300 | 34150 | 21911 | 10 | 13243 | 553000 |
| 2.b. | Rats | 86363 | 55681 | 67788 | 205 | 17730 | 1340 | 159 | 1081 | 230347 |
| 2.c. | Guinea-Pigs | 2710 | 2170 | 3521 | 397 | 4751 | 30 | 0 | 296 | 13875 |
| 2.d. | Hamsters | 227 | 258 | 0 | 0 | 145 | 87 | 0 | 0 | 717 |
| 2.e. | Other Rodents | 160 | 215 | 0 | 0 | 0 | 860 | 0 | 0 | 1235 |
| 2.f. | Rabbits | 1628 | 1140 | 4538 | 305 | 2009 | 6 | 0 | 80 | 9706 |
| 2.g. | Cats | 26 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 26 |
| 2.h. | Dogs | 20 | 46 | 0 | 0 | 877 | 0 | 0 | 0 | 943 |
| 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 | 31 | 0 | 15 | 0 | 0 | 0 | 0 | 0 | 46 |
| 2.l. | Pigs | 1350 | 1174 | 15 | 84 | 435 | 0 | 344 | 205 | 3607 |
| 2.m. | Goats | 37 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 41 |
| 2.n. | Sheep | 171 | 190 | 62 | 12 | 23 | 0 | 0 | 11 | 469 |
| 2.o. | Cattle | 270 | 134 | 0 | 6 | 9 | 2 | 0 | 41 | 462 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.q. | New World Monkeys | 0 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 18 |
| 2.r. | Old World Monkeys | 12 | 41 | 51 | 0 | 238 | 0 | 0 | 2 | 344 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 104 | 0 | 0 | 47 | 0 | 0 | 0 | 0 | 151 |
| 2.u. | Quail | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 245 | 249 |
| 2.v. | Other birds | 7393 | 3565 | 12 | 12736 | 6621 | 1081 | 0 | 833 | 32241 |
| 2.w. | Reptiles | 454 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 454 |
| 2.x. | Amphibians | 2346 | 20 | 0 | 0 | 0 | 66 | 0 | 0 | 2432 |
| 2.y. | Fish | 6049 | 400 | 0 | 2518 | 2018 | 0 | 0 | 2970 | 13955 |
| 2.z. | TOTAL | 421162 | 208211 | 102425 | 18611 | 69006 | 25383 | 513 | 19007 | 864318 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual 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 | 8016 | 80 | 208 | 0 | 0 | 54 | 169 | 4082 | 21541 | 34150 |
| 3.b. | Rats | 14149 | 254 | 1142 | 0 | 0 | 205 | 0 | 0 | 1980 | 17730 |
| 3.c. | Guinea-Pigs | 4408 | 87 | 215 | 0 | 0 | 0 | 0 | 0 | 41 | 4751 |
| 3.d. | Hamsters | 145 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 145 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 1896 | 9 | 41 | 0 | 0 | 0 | 0 | 0 | 63 | 2009 |
| 3.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.h. | Dogs | 877 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 877 |
| 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 | 147 | 0 | 0 | 0 | 0 | 0 | 288 | 0 | 0 | 435 |
| 3.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.n. | Sheep | 23 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 23 |
| 3.o. | Cattle | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 |
| 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 | 238 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 238 |
| 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 | 5691 | 450 |  |  |  |  | 480 | 0 | 0 | 6621 |
| 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 | 210 | 0 | 158 | 0 | 0 | 0 | 0 | 1650 | 0 | 2018 |
| 3.z. | TOTAL | 35809 | 880 | 1764 | 0 | 0 | 259 | 937 | 5732 | 23625 | 69006 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 17719 | 72970 | 123899 | 130189 | 7073 | 351850 |
| 4.b. | Rats | 6348 | 42732 | 4325 | 33482 | 545 | 87432 |
| 4.c. | Guinea-Pigs | 380 | 326 | 0 | 2366 | 182 | 3254 |
| 4.d. | Hamsters | 20 | 21 | 50 | 357 | 0 | 448 |
| 4.e. | Other Rodents | 0 | 244 | 0 | 297 | 654 | 1195 |
| 4.f. | Rabbits | 82 | 262 | 54 | 1410 | 13 | 1821 |
| 4.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.h. | Dogs | 12 | 0 | 0 | 17 | 0 | 29 |
| 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 | 31 | 31 |
| 4.l. | Pigs | 163 | 0 | 8 | 170 | 110 | 451 |
| 4.m. | Goats | 0 | 0 | 0 | 0 | 3 | 3 |
| 4.n. | Sheep | 31 | 0 | 0 | 42 | 16 | 89 |
| 4.o. | Cattle | 7 | 0 | 0 | 2 | 2 | 11 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 0 | 18 | 0 | 0 | 0 | 18 |
| 4.r. | Old World Monkeys | 0 | 2 | 0 | 41 | 0 | 43 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 0 | 0 | 0 | 0 | 6 | 6 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 249 | 249 |
| 4.v. | Other birds | 0 | 0 | 0 | 0 | 1358 | 1358 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 86 | 86 |
| 4.x. | Amphibians | 0 | 101 | 0 | 241 | 66 | 408 |
| 4.y. | Fish | 0 | 0 | 1629 | 66 | 3268 | 4963 |
| 4.z. | TOTAL | 24762 | 116676 | 129965 | 168680 | 13662 | 453745 |

  

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 | | | 6375 | 7376 | 0 | | 100 | 13027 | 1845 | 28723 |
| 5.b. | Rats | | | 241 | 1730 | 0 | | 0 | 64208 | 1814 | 67993 |
| 5.c. | Guinea-Pigs | | | 657 | 627 | 0 | | 0 | 2634 | 0 | 3918 |
| 5.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 344 | 3773 | 0 | | 0 | 714 | 12 | 4843 |
| 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 | | | 15 | 0 | 0 | | 0 | 0 | 0 | 15 |
| 5.l. | Pigs | | | 99 | 0 | 0 | | 0 | 0 | 0 | 99 |
| 5.m. | Goats | | | 1 | 0 | 0 | | 0 | 0 | 0 | 1 |
| 5.n. | Sheep | | | 65 | 0 | 0 | | 0 | 0 | 9 | 74 |
| 5.o. | Cattle | | | 6 | 0 | 0 | | 0 | 0 | 0 | 6 |
| 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 | 51 | 0 | 51 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 13 | 34 | 0 | | 0 | 0 | 0 | 47 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 853 | 11895 | 0 | | 0 | 0 | 0 | 12748 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 2170 | 0 | 0 | | 0 | 348 | 0 | 2518 |
| 5.z. | TOTAL | | | 10839 | 25435 | 0 | | 100 | 80982 | 3680 | 121036 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 19994 | 4665 | 0 | | 0 | 9102 | 389 | 34150 |
| 6.b. | Rats | | | 2093 | 5724 | 0 | | 0 | 9557 | 356 | 17730 |
| 6.c. | Guinea-Pigs | | | 104 | 3731 | 0 | | 0 | 916 | 0 | 4751 |
| 6.d. | Hamsters | | | 0 | 122 | 0 | | 0 | 23 | 0 | 145 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 6 | 1389 | 0 | | 0 | 566 | 48 | 2009 |
| 6.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.h. | Dogs | | | 176 | 305 | 0 | | 0 | 396 | 0 | 877 |
| 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 | 435 | 0 | | 0 | 0 | 0 | 435 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 23 | 0 | | 0 | 0 | 0 | 23 |
| 6.o. | Cattle | | | 0 | 9 | 0 | | 0 | 0 | 0 | 9 |
| 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 | 238 | 0 | 238 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 0 | 6171 | 0 | | 0 | 0 | 450 | 6621 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 1650 | 158 | 0 | | 0 | 0 | 210 | 2018 |
| 6.z. | TOTAL | | | 24023 | 22732 | 0 | | 0 | 20798 | 1453 | 69006 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino-genicity | 7.8  Develop-mental toxicity | 7.9  Muta-genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 590 | 5698 | 7128 | 110 | 0 | 0 | 5666 | 77 | 177 | 344 | 743 | 0 | 13617 | 34150 |
| 7.b. | Rats | 104 | 453 | 3884 | 38 | 2 | 0 | 10261 | 2 | 507 | 363 | 717 | 0 | 1399 | 17730 |
| 7.c. | Guinea-Pigs | 0 | 0 | 23 | 80 | 4630 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 18 | 4751 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 145 | 145 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 0 | 0 | 371 | 250 | 0 | 90 | 130 | 0 | 235 | 0 | 0 | 0 | 933 | 2009 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.h. | Dogs | 0 | 0 | 179 | 0 | 0 | 0 | 681 | 0 | 0 | 0 | 0 | 0 | 17 | 877 |
| 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 | 56 | 0 | 0 | 0 | 40 | 0 | 0 | 0 | 0 | 0 | 339 | 435 |
| 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 | 23 | 23 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 9 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 57 | 0 | 0 | 0 | 122 | 0 | 0 | 0 | 0 | 0 | 59 | 238 |
| 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 | 4595 | 1020 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1006 | 6621 |
| 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 | 930 | 0 | 368 | 0 | 0 | 0 | 720 | 0 | 0 | 0 | 0 | 0 | 0 | 2018 |
| 7.z. | TOTAL | 1624 | 6151 | 16661 | 1498 | 4632 | 90 | 17620 | 79 | 919 | 707 | 1460 | 0 | 17565 | 69006 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta-genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 184 | 350 | 12772 | 1469 | 4330 | 69 | 11879 | 79 | 625 | 513 | 701 | 0 | 2838 | 35809 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 0 | 120 | 65 | 3 | 87 | 6 | 0 | 0 | 0 | 0 | 100 | 0 | 499 | 880 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 0 | 224 | 361 | 26 | 215 | 15 | 200 | 0 | 244 | 194 | 189 | 0 | 96 | 1764 |
| 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 | 35 | 0 | 0 | 0 | 174 | 0 | 50 | 0 | 0 | 0 | 0 | 259 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 169 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 768 | 937 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 930 | 0 | 0 | 0 | 0 | 0 | 3099 | 0 | 0 | 0 | 470 | 0 | 1233 | 5732 |
| 8.i. | Other toxicological or safety evaluations | 510 | 5288 | 3428 | 0 | 0 | 0 | 2268 | 0 | 0 | 0 | 0 | 0 | 12131 | 23625 |
| 8.j. | TOTAL | 1624 | 6151 | 16661 | 1498 | 4632 | 90 | 17620 | 79 | 919 | 707 | 1460 | 0 | 17565 | 69006 |

CYPRUS

Statistical data submitted

The statistical data have been submitted by “Veterinary Services of the Republic of Cyprus”.

Remark: Cyprus reported data only in tables 1, 2, 4 and 5. The remaining tables are not applicable.

Comments of the Cypriot authorities

At present only rodents (mice) are used in animal experimentation in Cyprus. The use of experimental mice concentrates mainly on the generation and use of genetically modified mice to study basic biological processes like:

Development of the central nervous system and early development of the mouse embryo.

Generation of mouse models of inherited diseases or diseases with a genetic component and study of disease progression. These include haemoglobinopathies and neurodegenerative diseases.

Testing of genetically engineered molecules as putative anti-neoplastic agents on genetically immuno-compromised animals, challenged with carcinogenic cells.

Testing of modified forms of natural vitamins as potential antioxidants on induced models of diabetes.

Use of mice to study the effect of various agents on heart physiology.

The Veterinary Services are satisfied that the animals are kept in a very rigorously monitored, pathogen-free environment (monitored according to FELASA guidelines). No outbreak of all pathogens tested has been observed. We are also satisfied that the principles of the three Rs are duly adhered to.

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) | 2114 | 2114 |  |  |  |  |
| 1.b. | Rats (Rattus norvegicus) | 0 |  |  |  |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 0 |  |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 0 |  |  |  |  |  |
| 1.g. | Cats (Felis catus) | 0 |  |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 0 |  |  |  |  |  |
| 1.i. | Ferrets (Mustela putorius furo) | 0 |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) |  |  |  |  |  |  |
| 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 | 2114 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 1701 |  | 320 |  |  |  | 93 |  | 2114 |
| 2.b. | Rats |  |  |  |  |  |  |  |  | 0 |
| 2.c. | Guinea-Pigs |  |  |  |  |  |  |  |  | 0 |
| 2.d. | Hamsters |  |  |  |  |  |  |  |  | 0 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits |  |  |  |  |  |  |  |  | 0 |
| 2.g. | Cats |  |  |  |  |  |  |  |  | 0 |
| 2.h. | Dogs |  |  |  |  |  |  |  |  | 0 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  | 0 |
| 2.l. | Pigs |  |  |  |  |  |  |  |  | 0 |
| 2.m. | Goats |  |  |  |  |  |  |  |  | 0 |
| 2.n. | Sheep |  |  |  |  |  |  |  |  | 0 |
| 2.o. | Cattle |  |  |  |  |  |  |  |  | 0 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals |  |  |  |  |  |  |  |  | 0 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds |  |  |  |  |  |  |  |  | 0 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  | 0 |
| 2.y. | Fish |  |  |  |  |  |  |  |  | 0 |
| 2.z. | TOTAL | 1701 | 0 | 320 | 0 | 0 | 0 | 93 | 0 | 2114 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice |  | 205 | 70 | 165 |  | 440 |
| 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 | 205 | 70 | 165 | 0 | 440 |

  

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 | | |  |  |  | |  |  | 320 | 320 |
| 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 | 320 | 320 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

LATVIA

Statistical data submitted

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

Comments of Latvian authorities

None

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) | 6912 | 6912 |  |  |  |  |
| 1.b. | Rats (Rattus norvegicus) | 2407 | 2407 |  |  |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 32 | 32 |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 48 | 48 |  |  |  |  |
| 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 | 9399 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 1032 | 1952 | 2710 |  |  | 668 | 550 |  | 6912 |
| 2.b. | Rats | 325 | 460 | 1037 |  |  | 280 | 305 |  | 2407 |
| 2.c. | Guinea-Pigs |  |  |  |  | 32 |  |  |  | 32 |
| 2.d. | Hamsters |  |  |  |  |  |  |  |  | 0 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits |  |  | 48 |  |  |  |  |  | 48 |
| 2.g. | Cats |  |  |  |  |  |  |  |  | 0 |
| 2.h. | Dogs |  |  |  |  |  |  |  |  | 0 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  | 0 |
| 2.l. | Pigs |  |  |  |  |  |  |  |  | 0 |
| 2.m. | Goats |  |  |  |  |  |  |  |  | 0 |
| 2.n. | Sheep |  |  |  |  |  |  |  |  | 0 |
| 2.o. | Cattle |  |  |  |  |  |  |  |  | 0 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals |  |  |  |  |  |  |  |  | 0 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds |  |  |  |  |  |  |  |  | 0 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  | 0 |
| 2.y. | Fish |  |  |  |  |  |  |  |  | 0 |
| 2.z. | TOTAL | 1357 | 2412 | 3795 | 0 | 32 | 948 | 855 | 0 | 9399 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami-nants in the general envi-ronment which do not appear in other columns | 3.10  Other toxico-logical or safety evaluations | 3.11  Total |
| 3.a. | Mice |  |  |  |  |  |  |  |  |  | 0 |
| 3.b. | Rats |  |  |  |  |  |  |  |  |  | 0 |
| 3.c. | Guinea-Pigs | 32 |  |  |  |  |  |  |  |  | 32 |
| 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 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 32 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 995 | 634 | 1353 | 548 | 122 | 3652 |
| 4.b. | Rats | 394 | 195 | 360 | 116 |  | 1065 |
| 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 | 1389 | 829 | 1713 | 664 | 122 | 4717 |

  

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 | | |  |  |  | |  | 2710 |  | 2710 |
| 5.b. | Rats | | |  |  |  | |  | 1037 |  | 1037 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | |  |  |  | |  | 48 |  | 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 | | |  |  |  | |  |  |  | 0 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 0 | 0 | 0 | | 0 | 3795 | 0 | 3795 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | |  |  |  | |  |  |  | 0 |
| 6.b. | Rats | | |  |  |  | |  |  |  |  |
| 6.c. | Guinea-Pigs | | |  |  |  | |  | 32 |  | 32 |
| 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 | 32 | 0 | 32 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino-  genicity | 7.8  Develop-mental toxicity | 7.9  Muta-genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.b. | Rats |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 7.c. | Guinea-Pigs |  |  |  | 32 |  |  |  |  |  |  |  |  |  | 32 |
| 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 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 32 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine |  |  |  | 32 |  |  |  |  |  |  |  |  |  | 32 |
| 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 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 32 |

LITHUANIA

Statistical data submitted

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

Comments of Lithuanian authorities

The legal basis for the collection of statistics on the number and use of vertebrate animals for experimental and other scientific purposes in Lithuania is provided by the State Food and Veterinary Service Director Decree No B1-639 (Government Gazette 2009-01-22, No 8-287) on the protection of animals used for experimental and other scientific purposes, in accordance with Council Directive 86/609/EEC and European Convention on the protection of animals used for experimental and other scientific purposes

The total number of animals used in experiments in Lithuania in 2008 was 5,582 of which 100% animals came from registered breeding or supplying establishments within the reporting country.

Rodents accounted for 91,61% of all animals used – 5,114 animals (3,827 mice – accounting for 68,56%, 1,194 rats - accounting for 21,39%, 93 guinea pigs – accounting for 1,67%)

A further 3,56% (199 animals) were rabbits.

Cold-blooded animals (fish and amphibians) represented 2,67% of the animals used, 149 animals, of which 28,86% were used for research and development of medical, dental and veterinary products and appliances, 71,14% for education and training purposes.

Pigs accounted for 1,43% of the animals used (80 animals), of which 37,5% were used for research and development of medical, dental and veterinary products and appliances, 62,5% for education and training purposes.

Birds accounted for 0,71% (40 animals), of which 100% were used for research and development of medical, dental and veterinary products and appliances.

No animals were re-used.

No primates were used.

No animals were used in the testing of cosmetic products.

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) | 3827 | 3827 |  |  |  |  |
| 1.b. | Rats (Rattus norvegicus) | 1194 | 1194 |  |  |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 93 | 93 |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 199 | 199 |  |  |  |  |
| 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) | 80 |  |  |  |  |  |
| 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) | 40 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 149 |  |  |  |  |  |
| 1.y. | Fish (Pisces) |  |  |  |  |  |  |
| 1.z. | TOTAL | 5582 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
  
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 718 | 1367 | 525 |  | 1213 |  | 4 |  | 3827 |
| 2.b. | Rats | 44 | 1070 | 33 |  | 26 |  | 21 |  | 1194 |
| 2.c. | Guinea-Pigs | 41 | 40 |  | 5 | 7 |  |  |  | 93 |
| 2.d. | Hamsters |  |  |  |  |  |  |  |  | 0 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits | 8 | 148 |  | 5 | 7 |  | 31 |  | 199 |
| 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 |  | 30 |  |  |  |  | 50 |  | 80 |
| 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 |  | 40 |  |  |  |  |  |  | 40 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  | 43 |  |  |  |  | 106 |  | 149 |
| 2.y. | Fish |  |  |  |  |  |  |  |  | 0 |
| 2.z. | TOTAL | 811 | 2738 | 558 | 10 | 1253 | 0 | 212 | 0 | 5582 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami-nants in the general envi-ronment which do not appear in other columns | 3.10  Other toxico-logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 239 |  |  |  |  |  | 200 |  | 774 | 1213 |
| 3.b. | Rats |  |  |  |  |  |  | 26 |  |  | 26 |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  | 7 |  |  | 7 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits |  |  |  |  |  |  | 7 |  |  | 7 |
| 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 | 239 | 0 | 0 | 0 | 0 | 0 | 240 | 0 | 774 | 1253 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 189 |  | 300 | 1496 | 100 | 2085 |
| 4.b. | Rats | 22 |  | 33 | 959 | 100 | 1114 |
| 4.c. | Guinea-Pigs | 39 |  |  | 22 | 20 | 81 |
| 4.d. | Hamsters |  |  |  |  |  | 0 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits | 30 | 24 |  | 82 | 20 | 156 |
| 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 | 30 |  |  |  |  | 30 |
| 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 |  |  |  | 20 | 20 | 40 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  | 43 |  |  |  | 43 |
| 4.y. | Fish |  |  |  |  |  | 0 |
| 4.z. | TOTAL | 310 | 67 | 333 | 2579 | 260 | 3549 |

  

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 | | | 525 |  |  | |  |  |  | 525 |
| 5.b. | Rats | | | 33 |  |  | |  |  |  | 33 |
| 5.c. | Guinea-Pigs | | | 5 |  |  | |  |  |  | 5 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | | 5 |  |  | |  |  |  | 5 |
| 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 | | | 568 | 0 | 0 | | 0 | 0 | 0 | 568 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. |  | | | 1013 | 200 |  | |  |  |  | 1213 |
| 6.b. |  | | |  | 26 |  | |  |  |  | 26 |
| 6.c. |  | | |  | 7 |  | |  |  |  | 7 |
| 6.d. |  | | |  |  |  | |  |  |  | 0 |
| 6.e. |  | | |  |  |  | |  |  |  | 0 |
| 6.f. |  | | |  | 7 |  | |  |  |  | 7 |
| 6.g. |  | | |  |  |  | |  |  |  | 0 |
| 6.h. |  | | |  |  |  | |  |  |  | 0 |
| 6.i. |  | | |  |  |  | |  |  |  | 0 |
| 6.j. |  | | |  |  |  | |  |  |  | 0 |
| 6.k. |  | | |  |  |  | |  |  |  | 0 |
| 6.l. |  | | |  |  |  | |  |  |  | 0 |
| 6.m. |  | | |  |  |  | |  |  |  | 0 |
| 6.n. |  | | |  |  |  | |  |  |  | 0 |
| 6.o. |  | | |  |  |  | |  |  |  | 0 |
| 6.p. |  | | |  |  |  | |  |  |  | 0 |
| 6.q. |  | | |  |  |  | |  |  |  | 0 |
| 6.r. |  | | |  |  |  | |  |  |  | 0 |
| 6.s. |  | | |  |  |  | |  |  |  | 0 |
| 6.t. |  | | |  |  |  | |  |  |  | 0 |
| 6.u. |  | | |  |  |  | |  |  |  | 0 |
| 6.v. |  | | |  |  |  | |  |  |  | 0 |
| 6.w. |  | | |  |  |  | |  |  |  | 0 |
| 6.x. |  | | |  |  |  | |  |  |  | 0 |
| 6.y. |  | | |  |  |  | |  |  |  | 0 |
| 6.z. |  | | | 1013 | 240 | 0 | | 0 | 0 | 0 | 1253 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino-genicity | 7.8  Develop-mental toxicity | 7.9  Muta-genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 172 |  |  |  |  |  |  |  |  | 246 |  | 200 | 595 | 1213 |
| 7.b. | Rats |  |  |  |  |  |  |  |  |  |  |  | 26 |  | 26 |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  | 7 |  | 7 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |  | 7 |  | 7 |
| 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 | 172 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 246 | 0 | 240 | 595 | 1253 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 172 |  |  |  |  |  |  |  |  |  |  |  | 67 | 239 |
| 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 |  |  |  |  |  |  |  |  |  |  |  |  | 240 | 240 |
| 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 |  |  |  |  |  |  |  |  |  | 246 |  |  | 528 | 774 |
| 8.j. | TOTAL | 172 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 246 | 0 | 0 | 835 | 1253 |

LUXEMBOURG

Statistical data submitted

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

Remark: Luxembourg reported data only in tables 1, 2 and 4 with the remaining tables not applicable.

Comments of Luxembourg authorities

None

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) | 430 | 430 |  |  |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 100 | 100 |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) | 0 |  |  |  |  |  |
| 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) | 0 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 0 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 0 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 0 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 0 |  |  |  |  |  |
| 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) | 0 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 0 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 0 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 0 |  |  |  |  |  |
| 1.z. | TOTAL | 3830 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice |  | 3280 |  |  |  |  |  |  | 3280 |
| 2.b. | Rats |  | 430 |  |  |  |  |  |  | 430 |
| 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 |
| 2.z. | TOTAL | 0 | 3830 | 0 | 0 | 0 | 0 | 0 | 0 | 3830 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice |  |  |  |  | 3280 | 3280 |
| 4.b. | Rats |  |  |  |  | 430 | 430 |
| 4.c. | Guinea-Pigs |  |  |  |  | 100 | 100 |
| 4.d. | Hamsters |  |  |  |  |  | 0 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits |  |  |  |  | 20 | 20 |
| 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 | 3830 | 3830 |

HUNGARY

Statistical data submitted

The statistical data have been submitted by the Ministry of Agriculture and Rural Development.

Comments of the Hungarian authorities

None

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) | 158799 | 129817 | 26099 | 1131 | 1752 |  |
| 1.b. | Rats (Rattus norvegicus) | 89375 | 73336 | 15248 | 340 | 451 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 9743 | 6064 | 3669 | 10 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 215 | 215 | 0 | 0 | 0 |  |
| 1.e. | Other Rodents (other Rodentia) | 356 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 8134 | 7560 | 14 | 360 | 200 | 598 |
| 1.g. | Cats (Felis catus) | 40 | 40 | 0 | 0 | 0 |  |
| 1.h. | Dogs (Canis familiaris) | 686 | 412 | 12 | 262 | 0 | 65 |
| 1.i. | Ferrets (Mustela putorius furo) | 0 |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) | 0 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 40 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 1193 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 92 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 200 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 93 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) | 5 | 5 |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 1 | 1 |  |  |  |  |
| 1.s. | Apes (Hominoidea) | 0 |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) | 16 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 13 | 13 |  |  |  |  |
| 1.v. | Other birds (other Aves) | 32554 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 108 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 1182 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 2077 |  |  |  |  |  |
| 1.z. | TOTAL | 304922 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 50186 | 57384 | 23136 | 0 | 13495 | 3935 | 5706 | 4957 | 158799 |
| 2.b. | Rats | 24239 | 60144 | 0 | 0 | 2809 | 15 | 2143 | 25 | 89375 |
| 2.c. | Guinea-Pigs | 2304 | 629 | 3699 | 774 | 2006 | 0 | 235 | 96 | 9743 |
| 2.d. | Hamsters | 214 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 215 |
| 2.e. | Other Rodents | 356 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 356 |
| 2.f. | Rabbits | 1360 | 2183 | 0 | 618 | 3620 | 66 | 287 | 0 | 8134 |
| 2.g. | Cats | 6 | 34 | 0 | 0 | 0 | 0 | 0 | 0 | 40 |
| 2.h. | Dogs | 352 | 59 | 7 | 0 | 240 | 0 | 23 | 5 | 686 |
| 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 | 0 | 0 | 0 | 0 | 0 | 0 | 40 | 0 | 40 |
| 2.l. | Pigs | 399 | 292 | 0 | 159 | 156 | 130 | 57 | 0 | 1193 |
| 2.m. | Goats | 2 | 0 | 0 | 0 | 0 | 50 | 40 | 0 | 92 |
| 2.n. | Sheep | 10 | 26 | 0 | 82 | 0 | 0 | 82 | 0 | 200 |
| 2.o. | Cattle | 6 | 4 | 0 | 2 | 30 | 51 | 0 | 0 | 93 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.q. | New World Monkeys | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| 2.r. | Old World Monkeys | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 0 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 16 |
| 2.u. | Quail | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 |
| 2.v. | Other birds | 7558 | 8158 | 0 | 13390 | 462 | 10 | 576 | 2400 | 32554 |
| 2.w. | Reptiles | 0 | 50 | 0 | 0 | 0 | 0 | 58 | 0 | 108 |
| 2.x. | Amphibians | 120 | 0 | 0 | 0 | 0 | 0 | 1062 | 0 | 1182 |
| 2.y. | Fish | 345 | 0 | 0 | 0 | 1126 | 100 | 506 | 0 | 2077 |
| 2.z. | TOTAL | 87476 | 128979 | 26842 | 15025 | 23944 | 4357 | 10816 | 7483 | 304922 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 11093 | 0 | 0 | 0 | 0 | 0 | 288 | 0 | 2114 | 13495 |
| 3.b. | Rats | 1129 | 0 | 0 | 0 | 0 | 78 | 0 | 0 | 1602 | 2809 |
| 3.c. | Guinea-Pigs | 1236 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 770 | 2006 |
| 3.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 3428 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 192 | 3620 |
| 3.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.h. | Dogs | 240 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 240 |
| 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 | 122 | 0 | 0 | 0 | 0 | 0 | 0 | 34 | 0 | 156 |
| 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 | 30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 30 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.v. | Other birds | 462 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 462 |
| 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 | 126 | 0 | 0 | 0 | 0 | 0 | 1000 | 0 | 1126 |
| 3.z. | TOTAL | 17740 | 126 | 0 | 0 | 0 | 78 | 288 | 1034 | 4678 | 23944 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 886 | 69114 | 8615 | 27448 | 5442 | 111505 |
| 4.b. | Rats | 2564 | 72436 | 1777 | 7621 | 0 | 84398 |
| 4.c. | Guinea-Pigs | 72 | 314 | 0 | 2482 | 65 | 2933 |
| 4.d. | Hamsters | 0 | 109 | 0 | 83 | 22 | 214 |
| 4.e. | Other Rodents | 0 | 290 | 0 | 66 | 0 | 356 |
| 4.f. | Rabbits | 447 | 613 | 0 | 1782 | 767 | 3609 |
| 4.g. | Cats | 0 | 30 | 0 | 0 | 10 | 40 |
| 4.h. | Dogs | 390 | 21 | 0 | 0 | 0 | 411 |
| 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 | 194 | 0 | 0 | 0 | 627 | 821 |
| 4.m. | Goats | 2 | 0 | 0 | 0 | 50 | 52 |
| 4.n. | Sheep | 0 | 0 | 0 | 0 | 36 | 36 |
| 4.o. | Cattle | 0 | 0 | 0 | 0 | 61 | 61 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 5 | 0 | 0 | 0 | 0 | 5 |
| 4.r. | Old World Monkeys | 1 | 0 | 0 | 0 | 0 | 1 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 16 | 0 | 0 | 0 | 0 | 16 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 13 | 13 |
| 4.v. | Other birds | 0 | 0 | 0 | 0 | 15726 | 15726 |
| 4.w. | Reptiles | 0 | 50 | 0 | 0 | 0 | 50 |
| 4.x. | Amphibians | 0 | 120 | 0 | 0 | 0 | 120 |
| 4.y. | Fish | 0 | 0 | 0 | 0 | 445 | 445 |
| 4.z. | TOTAL | 4577 | 143097 | 10392 | 39482 | 23264 | 220812 |

  

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 | | | 9363 | 13523 | 0 | | 0 | 250 | 0 | 23136 |
| 5.b. | Rats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.c. | Guinea-Pigs | | | 586 | 3887 | 0 | | 0 | 0 | 0 | 4473 |
| 5.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 40 | 578 | 0 | | 0 | 0 | 0 | 618 |
| 5.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.h. | Dogs | | | 7 | 0 | 0 | | 0 | 0 | 0 | 7 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.l. | Pigs | | | 0 | 159 | 0 | | 0 | 0 | 0 | 159 |
| 5.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.n. | Sheep | | | 6 | 76 | 0 | | 0 | 0 | 0 | 82 |
| 5.o. | Cattle | | | 0 | 2 | 0 | | 0 | 0 | 0 | 2 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 11 | 13379 | 0 | | 0 | 0 | 0 | 13390 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 10013 | 31604 | 0 | | 0 | 250 | 0 | 41867 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 60 | 12533 | 0 | | 0 | 460 | 442 | 13495 |
| 6.b. | Rats | | | 152 | 1657 | 0 | | 0 | 910 | 90 | 2809 |
| 6.c. | Guinea-Pigs | | | 0 | 1236 | 0 | | 0 | 770 | 0 | 2006 |
| 6.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 550 | 2878 | 0 | | 0 | 192 | 0 | 3620 |
| 6.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.h. | Dogs | | | 110 | 66 | 58 | | 6 | 0 | 0 | 240 |
| 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 | | | 81 | 67 | 8 | | 0 | 0 | 0 | 156 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.o. | Cattle | | | 0 | 30 | 0 | | 0 | 0 | 0 | 30 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 0 | 462 | 0 | | 0 | 0 | 0 | 462 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 1000 | 126 | 0 | | 0 | 0 | 0 | 1126 |
| 6.z. | TOTAL | | | 1953 | 19055 | 66 | | 6 | 2332 | 532 | 23944 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 3307 | 4492 | 3194 | 0 | 0 | 0 | 160 | 0 | 0 | 323 | 0 | 0 | 2019 | 13495 |
| 7.b. | Rats | 30 | 26 | 1200 | 0 | 85 | 0 | 400 | 24 | 190 | 30 | 218 | 0 | 606 | 2809 |
| 7.c. | Guinea-Pigs | 0 | 0 | 976 | 0 | 420 | 0 | 490 | 0 | 120 | 0 | 0 | 0 | 0 | 2006 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 0 | 0 | 3420 | 41 | 4 | 28 | 0 | 0 | 127 | 0 | 0 | 0 | 0 | 3620 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 0 | 0 | 0 | 0 | 0 |
| 7.h. | Dogs | 0 | 0 | 108 | 0 | 0 | 0 | 132 | 0 | 0 | 0 | 0 | 0 | 0 | 240 |
| 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 | 77 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 0 | 0 | 59 | 156 |
| 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 | 30 | 30 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.v. | Other birds | 72 | 0 | 390 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 462 |
| 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 | 626 | 0 | 0 |  | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 500 | 0 | 1126 |
| 7.z. | TOTAL | 4035 | 4518 | 9365 | 41 | 509 | 28 | 1202 | 24 | 437 | 353 | 218 | 500 | 2714 | 23944 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 3374 | 4492 | 6997 | 41 | 509 | 28 | 1202 | 0 | 437 | 353 | 218 | 0 | 89 | 17740 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 126 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 126 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 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 | 26 | 28 | 0 | 0 | 0 | 0 | 24 | 0 | 0 | 0 | 0 | 0 | 78 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 288 | 288 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 500 | 0 | 34 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 500 | 0 | 1034 |
| 8.i. | Other toxicological or safety evaluations | 35 | 0 | 2306 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2337 | 4678 |
| 8.j. | TOTAL | 4035 | 4518 | 9365 | 41 | 509 | 28 | 1202 | 24 | 437 | 353 | 218 | 500 | 2714 | 23944 |

MALTA

Statistical data submitted

The data were submitted by the Ministry of Resources and Rural Affairs

Comments of Malta authorities

None

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) | 50 |  | 50 |  |  |  |
| 1.b. | Rats (Rattus norvegicus) | 44 |  | 44 |  |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 0 |  |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 0 |  |  |  |  |  |
| 1.g. | Cats (Felis catus) | 0 |  |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 0 |  |  |  |  |  |
| 1.i. | Ferrets (Mustela putorius furo) | 0 |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) |  |  |  |  |  |  |
| 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) | 600 |  |  |  |  |  |
| 1.z. | TOTAL | 694 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
  
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice |  | 50 |  |  |  |  |  |  | 50 |
| 2.b. | Rats |  |  | 44 |  |  |  |  |  | 44 |
| 2.c. | Guinea-Pigs |  |  |  |  |  |  |  |  | 0 |
| 2.d. | Hamsters |  |  |  |  |  |  |  |  | 0 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits |  |  |  |  |  |  |  |  | 0 |
| 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 |  |  |  |  | 600 |  |  |  | 600 |
| 2.z. | TOTAL | 0 | 50 | 44 | 0 | 600 | 0 | 0 | 0 | 694 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami-nants in the general envi-ronment which do not appear in other columns | 3.10  Other toxico-logical or safety evaluations | 3.11  Total |
| 3.a. | Mice |  |  |  |  |  |  |  |  |  | 0 |
| 3.b. | Rats |  |  |  |  |  |  |  |  |  | 0 |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits |  |  |  |  |  |  |  |  |  | 0 |
| 3.g. | Cats |  |  |  |  |  |  |  |  |  | 0 |
| 3.h. | Dogs |  |  |  |  |  |  |  |  |  | 0 |
| 3.i. | Ferrets |  |  |  |  |  |  |  |  |  | 0 |
| 3.j. | Other Carnivores |  |  |  |  |  |  |  |  |  | 0 |
| 3.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  | 0 |
| 3.l. | Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.m. | Goats |  |  |  |  |  |  |  |  |  | 0 |
| 3.n. | Sheep |  |  |  |  |  |  |  |  |  | 0 |
| 3.o. | Cattle |  |  |  |  |  |  |  |  |  | 0 |
| 3.p. | Prosimians |  |  |  |  |  |  |  |  |  | 0 |
| 3.q. | New World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.s. | Apes |  |  |  |  |  |  |  |  |  | 0 |
| 3.t. | Other Mammals |  |  |  |  |  |  |  |  |  | 0 |
| 3.u. | Quail |  |  |  |  |  |  |  |  |  | 0 |
| 3.v. | Other birds |  |  |  |  |  |  |  |  |  | 0 |
| 3.w. | Reptiles |  |  |  |  |  |  |  |  |  | 0 |
| 3.x. | Amphibians |  |  |  |  |  |  |  |  |  | 0 |
| 3.y. | Fish | 600 |  |  |  |  |  |  |  |  | 600 |
| 3.z. | TOTAL | 600 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 600 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice |  | 50 |  |  |  | 50 |
| 4.b. | Rats |  |  | 44 |  |  | 44 |
| 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 | 50 | 44 | 0 | 0 | 94 |

  

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 | | | 44 |  |  | |  |  |  | 44 |
| 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 | | |  |  |  | |  |  |  |  |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | |  |  |  | |  |  |  | 0 |
| 6.b. | Rats | | |  |  |  | |  |  |  | 0 |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | |  |  |  | |  |  |  | 0 |
| 6.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 6.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 6.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 6.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 6.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 6.l. | Pigs | | |  |  |  | |  |  |  | 0 |
| 6.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 6.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 6.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 6.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 6.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 6.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 6.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 6.v. | Other birds | | |  |  |  | |  |  |  | 0 |
| 6.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 6.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 6.y. | Fish | | | 600 |  |  | |  |  |  | 600 |
| 6.z. | TOTAL | | | 600 | 0 | 0 | | 0 | 0 | 0 | 600 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino-genicity | 7.8  Develop- mental toxicity | 7.9  Muta-genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.b. | Rats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.h. | Dogs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.i. | Ferrets |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.j. | Other Carnivores |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.l. | Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.m. | Goats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.n. | Sheep |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.o. | Cattle |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.p. | Prosimians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.q. | New World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.s. | Apes |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.t. | Other Mammals |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.u. | Quail |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.v. | Other birds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.w. | Reptiles |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.x. | Amphibians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.y. | Fish | 600 |  |  |  |  |  |  |  |  |  |  |  |  | 600 |
| 7.z. | TOTAL | 600 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 600 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta-genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 600 |  |  |  |  |  |  |  |  |  |  |  |  | 600 |
| 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 | 600 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 600 |

THE NETHERLANDS

Statistical data submitted

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

The statistical data were prepared, quality assured and submitted by the Voedsel en Waren Autoriteit, (Dutch Food and Consumer Product Safety Authority

Comments of the Dutch authorities

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

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

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

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

Animal experiments for new or existing cosmetics are prohibited.

Since 2003 animal experiments on great apes are prohibited.

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

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

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

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

The creation of transgenic animals

Within the framework of the Animal Health and Welfare Act (1992) a system of licensing has entered into force with respect to experiments aiming at a genetic modification of animals. A national committee on ethical evaluation of genetic modification of animals, called the Committee on Animal Biotechnology will advise the Minister of Agriculture, Nature Management and Fisheries on the ethical aspects of the creation and the use of transgenic animals in general and on the admissibility of proposed projects.

In addition, such projects have to be evaluated within the framework of the Experiments of Animals Act and the Environmental Conservation Act.

The Inspectorate of the Food and Consumer Product Safety Authority is in charge of the supervision of these licences to create genetically modified animals.

In 2008 12,186 animals (12,052 mice, 72 rats and 62 fish) were used for the creation of transgenic animals.

Collection of data

87 establishments completed the 2008 registration form.

These establishments can be categorized as follows:

|  |  |  |
| --- | --- | --- |
| a) | Universities and university hospitals | 15 |
| b) | Other hospitals, regional public health laboratories | 1 |
| c) | Public health research institutes | 8 |
| d) | Agricultural and veterinary research institutes | 8 |
| e) | Other research institutes | 4 |
| f) | Industries and companies | 40 |
| g) | Schools for vocational training | 8 |
| h) | Breeders | 3 |

The killing of an animal without any previous intervention & re-use of animals

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

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

In 2008, 60,391 animals were killed without previous intervention.

Re-use of the animals (in 2008 17,220 animals) is included as well in the Dutch statistics.

  

Total number of animals used

In 2008, according to the EU Tables, the total number of animals used was 501,056.

This is 1,6% (10,060) less than the number of animals used in 2007 (513,423).

The total number of genetically modified animals that was used was 83,097. When split up into species, the numbers of genetically modified animals used are: 81,089 mice, 284 rats, 81 rabbits, 225 amphibians and 1,418 fish.

In 2008 the number of animals used for toxicological and other safety evaluation was decreased with 24,7% (13,431) compared to the number used in 2007.

Discomfort

General

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

As a consequence of the animal experiments performed in 2008:

33,66% of the animals experienced minor discomfort;

28,52% of the animals experienced minor/moderate discomfort;

25,05% of the animals experienced moderate discomfort;

9,11% of the animals experienced moderate/severe discomfort;

3,63% of the animals experienced severe discomfort and

0,03% of the animals experienced very severe discomfort.

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) | 237681 | 228113 | 8160 | 0 | 1408 | 2164 |
| 1.b. | Rats (Rattus norvegicus) | 105780 | 105300 | 231 | 0 | 249 | 2716 |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 6062 | 2939 | 3123 | 0 | 0 | 130 |
| 1.d. | Hamsters (Mesocricetus ) | 3358 | 3077 | 281 | 0 | 0 | 54 |
| 1.e. | Other Rodents (other Rodentia) | 2439 | 1642 | 73 | 0 | 724 | 0 |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 7418 | 6755 | 646 | 0 | 17 | 109 |
| 1.g. | Cats (Felis catus) | 253 | 100 | 0 | 0 | 153 | 23 |
| 1.h. | Dogs (Canis familiaris) | 1244 | 464 | 208 | 0 | 572 | 268 |
| 1.i. | Ferrets (Mustela putorius furo) | 472 | 0 | 193 | 0 | 279 | 20 |
| 1.j. | Other Carnivores (other Carnivora) | 10 | 0 | 0 | 0 | 10 | 0 |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 2562 | 3 | 0 | 0 | 2559 | 164 |
| 1.l. | Pigs (Sus) | 11729 | 4192 | 216 | 0 | 7321 | 125 |
| 1.m. | Goats (Capra) | 229 | 52 | 0 | 0 | 177 | 80 |
| 1.n. | Sheep (Ovis) | 3486 | 67 | 0 | 0 | 3419 | 470 |
| 1.o. | Cattle (Bos) | 2236 | 232 | 35 | 0 | 1969 | 187 |
| 1.p. | Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.q. | New World Monkeys (Ceboidea) | 73 | 73 | 0 | 0 | 0 | 8 |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 82 | 62 | 16 | 0 | 4 | 202 |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. | Other Mammals (other Mammalia) | 202 | 0 | 0 | 0 | 202 | 7 |
| 1.u. | Quail (Coturnix coturnix) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.v. | Other birds (other Aves) | 90890 | 12995 | 472 | 0 | 77423 | 4119 |
| 1.w. | Reptiles (Reptilia) | 121 | 100 | 0 | 0 | 21 | 28 |
| 1.x. | Amphibians (Amphibia) | 870 | 785 | 0 | 0 | 85 | 482 |
| 1.y. | Fish (Pisces) | 23859 | 8518 | 126 | 0 | 15215 | 270 |
| 1.z. | TOTAL | 501056 | 0 | 0 | 0 | 0 | 0 |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 152304 | 40617 | 5624 | 15653 | 7522 | 8859 | 7102 | 0 | 237681 |
| 2.b. | Rats | 31930 | 15348 | 28320 | 2700 | 23284 | 0 | 4198 | 0 | 105780 |
| 2.c. | Guinea-Pigs | 488 | 373 | 767 | 4181 | 183 | 0 | 70 | 0 | 6062 |
| 2.d. | Hamsters | 444 | 330 | 0 | 2539 | 30 | 0 | 15 | 0 | 3358 |
| 2.e. | Other Rodents | 2222 | 217 | 0 | 0 | 0 | 0 | 0 | 0 | 2439 |
| 2.f. | Rabbits | 727 | 393 | 16 | 1653 | 4543 | 5 | 81 | 0 | 7418 |
| 2.g. | Cats | 0 | 45 | 0 | 85 | 44 | 0 | 79 | 0 | 253 |
| 2.h. | Dogs | 157 | 285 | 11 | 187 | 519 | 0 | 85 | 0 | 1244 |
| 2.i. | Ferrets | 28 | 414 | 0 | 0 | 0 | 0 | 30 | 0 | 472 |
| 2.j. | Other Carnivores | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 |
| 2.k. | Horses, donkeys and cross breds | 65 | 377 | 110 | 2007 | 0 | 0 | 3 | 0 | 2562 |
| 2.l. | Pigs | 5138 | 3693 | 3 | 2283 | 188 | 0 | 424 | 0 | 11729 |
| 2.m. | Goats | 135 | 50 | 0 | 0 | 0 | 0 | 44 | 0 | 229 |
| 2.n. | Sheep | 133 | 639 | 2576 | 85 | 0 | 0 | 53 | 0 | 3486 |
| 2.o. | Cattle | 248 | 1012 | 129 | 598 | 0 | 0 | 249 | 0 | 2236 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.q. | New World Monkeys | 28 | 45 | 0 | 0 | 0 | 0 | 0 | 0 | 73 |
| 2.r. | Old World Monkeys | 21 | 61 | 0 | 0 | 0 | 0 | 0 | 0 | 82 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 202 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 202 |
| 2.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.v. | Other birds | 51806 | 17171 | 4 | 20684 | 0 | 395 | 830 | 0 | 90890 |
| 2.w. | Reptiles | 108 | 0 | 0 | 0 | 0 | 0 | 13 | 0 | 121 |
| 2.x. | Amphibians | 788 | 0 | 0 | 0 | 0 | 0 | 82 | 0 | 870 |
| 2.y. | Fish | 19503 | 0 | 0 | 0 | 3383 | 0 | 973 | 0 | 23859 |
| 2.z. | TOTAL | 266485 | 81070 | 37560 | 52655 | 39696 | 9259 | 14331 | 0 | 501056 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami-nants in the general envi-ronment which do not appear in other columns | 3.10  Other toxico-logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 3224 | 201 | 1499 | 0 | 0 | 2598 | 0 | 0 | 0 | 7522 |
| 3.b. | Rats | 5838 | 4193 | 11700 | 48 | 0 | 1286 | 177 | 0 | 42 | 23284 |
| 3.c. | Guinea-Pigs | 134 | 0 | 49 | 0 | 0 | 0 | 0 | 0 | 0 | 183 |
| 3.d. | Hamsters | 30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 30 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 2222 | 634 | 1681 | 0 | 0 | 6 | 0 | 0 | 0 | 4543 |
| 3.g. | Cats | 44 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 44 |
| 3.h. | Dogs | 471 | 48 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 519 |
| 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 | 26 | 0 | 0 | 0 | 0 | 0 | 162 | 0 | 0 | 188 |
| 3.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 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 | 353 | 0 | 365 | 0 | 0 | 0 | 0 | 2665 | 0 | 3383 |
| 3.z. | TOTAL | 12342 | 5076 | 15294 | 48 | 0 | 3890 | 339 | 2665 | 42 | 39696 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 16595 | 13267 | 47276 | 84369 | 11454 | 172961 |
| 4.b. | Rats | 4070 | 11472 | 1554 | 20855 | 46 | 37997 |
| 4.c. | Guinea-Pigs | 0 | 98 | 0 | 463 | 40 | 601 |
| 4.d. | Hamsters | 0 | 9 | 0 | 263 | 240 | 512 |
| 4.e. | Other Rodents | 0 | 27 | 0 | 619 | 0 | 646 |
| 4.f. | Rabbits | 369 | 5 | 56 | 476 | 38 | 944 |
| 4.g. | Cats | 0 | 0 | 0 | 6 | 39 | 45 |
| 4.h. | Dogs | 61 | 0 | 0 | 28 | 269 | 358 |
| 4.i. | Ferrets | 0 | 0 | 0 | 355 | 87 | 442 |
| 4.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 37 | 350 | 387 |
| 4.l. | Pigs | 293 | 0 | 36 | 263 | 3784 | 4376 |
| 4.m. | Goats | 106 | 0 | 0 | 75 | 4 | 185 |
| 4.n. | Sheep | 32 | 0 | 0 | 271 | 467 | 770 |
| 4.o. | Cattle | 0 | 0 | 0 | 129 | 997 | 1126 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 0 | 9 | 0 | 64 | 0 | 73 |
| 4.r. | Old World Monkeys | 0 | 0 | 0 | 72 | 0 | 72 |
| 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 | 1160 | 39694 | 40854 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.y. | Fish | 0 | 148 | 210 | 1003 | 95 | 1456 |
| 4.z. | TOTAL | 21526 | 25035 | 49132 | 110508 | 57604 | 263805 |

  

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 | 2725 | 0 | | 1978 | 15087 | 1487 | 21277 |
| 5.b. | Rats | | | 0 | 4000 | 0 | | 758 | 26194 | 68 | 31020 |
| 5.c. | Guinea-Pigs | | | 0 | 543 | 0 | | 160 | 2400 | 1845 | 4948 |
| 5.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 2539 | 0 | 2539 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 0 | 1 | 0 | | 0 | 1582 | 86 | 1669 |
| 5.g. | Cats | | | 27 | 0 | 0 | | 0 | 58 | 0 | 85 |
| 5.h. | Dogs | | | 22 | 0 | 0 | | 0 | 165 | 11 | 198 |
| 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 | 60 | 2057 | 2117 |
| 5.l. | Pigs | | | 0 | 0 | 0 | | 0 | 1610 | 676 | 2286 |
| 5.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.n. | Sheep | | | 2 | 0 | 0 | | 0 | 10 | 2649 | 2661 |
| 5.o. | Cattle | | | 16 | 0 | 0 | | 6 | 359 | 346 | 727 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 75 | 0 | 60 | | 0 | 15474 | 5079 | 20688 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 142 | 7269 | 60 | | 2902 | 65538 | 14304 | 90215 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 4 | 0 | 0 | | 0 | 6870 | 648 | 7522 |
| 6.b. | Rats | | | 77 | 0 | 0 | | 0 | 22654 | 553 | 23284 |
| 6.c. | Guinea-Pigs | | | 4 | 0 | 0 | | 0 | 57 | 122 | 183 |
| 6.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 30 | 0 | 30 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 0 | 0 | 0 | | 0 | 4540 | 3 | 4543 |
| 6.g. | Cats | | | 0 | 0 | 0 | | 0 | 44 | 0 | 44 |
| 6.h. | Dogs | | | 0 | 0 | 0 | | 0 | 519 | 0 | 519 |
| 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 | 13 | 175 | 188 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.o. | Cattle | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 77 | 0 | 0 | | 0 | 2898 | 408 | 3383 |
| 6.z. | TOTAL | | | 162 | 0 | 0 | | 0 | 37625 | 1909 | 39696 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino-genicity | 7.8  Develop- mental toxicity | 7.9  Muta-genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 0 | 251 | 396 | 0 | 2020 | 0 | 40 | 106 | 2293 | 1026 | 360 | 0 | 1030 | 7522 |
| 7.b. | Rats | 0 | 960 | 4486 | 391 | 0 | 0 | 3231 | 0 | 7844 | 553 | 4512 | 0 | 1307 | 23284 |
| 7.c. | Guinea-Pigs | 0 | 0 | 114 | 18 | 49 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 183 |
| 7.d. | Hamsters | 0 | 0 | 0 | 22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 30 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 0 | 0 | 508 | 249 | 0 | 186 | 428 | 0 | 0 | 0 | 2084 | 0 | 1088 | 4543 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 44 | 44 |
| 7.h. | Dogs | 0 | 0 | 227 | 0 | 0 | 0 | 250 | 0 | 0 | 0 | 0 | 0 | 42 | 519 |
| 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 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 175 | 188 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.y. | Fish | 1198 | 421 | 1344 | 119 | 0 | 0 | 301 | 0 | 0 | 0 | 0 | 0 | 0 | 3383 |
| 7.z. | TOTAL | 1198 | 1632 | 7088 | 799 | 2069 | 186 | 4250 | 106 | 10137 | 1579 | 6956 | 0 | 3696 | 39696 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta-genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 0 | 0406 | 03.645 | 0182 | 0832 | 028 | 02.490 | 0106 | 0 | 0673 | 0994 | 0 | 02.986 | 12342 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 0 | 034 | 0390 | 030 | 044 | 03 | 0120 | 0 | 0703 | 0184 | 03.568 | 0 | 0 | 5076 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 0365 | 0749 | 01.833 | 0465 | 01.193 | 0152 | 0288 | 0 | 07.141 | 0375 | 02.227 | 0 | 0506 | 15294 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 0 | 016 | 032 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 48 |
| 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 | 06 | 0120 | 03 | 0 | 03 | 0951 | 0 | 02.293 | 0305 | 0167 | 0 | 042 | 3890 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 077 | 0 | 0 | 0 | 0100 | 0 | 0 | 0 | 0 | 0 | 0162 | 339 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 0833 | 0421 | 0991 | 0119 | 0 | 0 | 0301 | 0 | 0 | 0 | 0 | 0 | 0 | 2665 |
| 8.i. | Other toxicological or safety evaluations | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 042 | 0 | 0 | 0 | 42 |
| 8.j. | TOTAL | 1198 | 1632 | 7088 | 799 | 2069 | 186 | 4250 | 106 | 10137 | 1579 | 6956 | 0 | 3696 | 39696 |

[Top](#document1)

EN

|  |  |
| --- | --- |
|  | EUROPEAN COMMISSION |

Brussels, 30.9.2010

SEC(2010) 1107 final

 

COMMISSION STAFF WORKING DOCUMENT

  

Accompanying document to the
  
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
  

  
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

COM(2010) 511 final

COMMISSION STAFF WORKING DOCUMENT

  

Accompanying document to the
  
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
  

  
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

TABLE OF CONTENTS

I.INTRODUCTION4

II.DATA SUBMITTED AND GENERAL ASSESSMENT6

II.1.Data submitted by the Member States6

II.2.General assessment6

II.3.Structure of the Report8

PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2008
   9

III.1.Results of EU Table 1: Species and number of animals9

III.2.Results of EU Table 1: Origin of animals used16

III.3.Results of EU Table 2: Purposes of the experiments19

III.4.Results of EU Table 3: Toxicological and safety evaluation by type of product/endpoint23

III.5.Results of EU Table 4: Animals used for studies of diseases26

III.6.Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine31

III.7.Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations34

III.8.Results of EU Table 7: Animals used in toxicity tests for toxicological and other safety evaluations37

III.9.Results of EU Table 8: Type of toxicity tests carried out for toxicological and other safety evaluations of products41

I.INTRODUCTION

The objective of this report is to present to the Council and the European Parliament, in accordance with Article 26 of Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes
[1](#footnote1)
, the statistical data on the number of animals used for experimental and other scientific purposes in the Member States of the EU.

The first two statistical reports drafted in accordance with the provisions of the above mentioned directive which were published in 1994
[2](#footnote2)
 and 1999
[3](#footnote3)
, covering data on experimental animals collected in 1991 and 1996 respectively in the Member States, allowed only a limited amount of statistical analysis due to the absence of a consistent system of reporting the data. In 1997 an agreement was reached between the Commission and the competent authorities of the Member States to submit data for future reports using a format of eight harmonized tables. The third and fourth statistical reports published in 2003
[4](#footnote4)
 and 2005
[5](#footnote5)
 covering data collected in 1999 and 2002 were based on these agreed harmonized tables. This allowed a much wider interpretation of the results on the use of experimental animals in the EU. In spite of the progress made in the content of these two statistical reports, it ought to be stressed that there were some inconsistencies in the data submitted by the Member States and also that in all cases except the report of 2003, one Member State collected data from another year. The Fifth Statistical Report, published in 2007
[6](#footnote6)
, contained for the first time data collected in the 10 Member States which joined the EU in 2004. In the Sixth Statistical Report the complete set of standardized tables provided by all 27 Member States were successfully evaluated, although comparison of the results with previous reports was essentially qualitative owing to the addition of data from the new Member States.

This Report includes data submitted by Romania and Bulgaria, which joined the EU in 2007. It gives an overview of the number of animals used in the Member States for experimental purposes for the year 2008 with the exception of one Member State which provided data from 2007.

The Commission Staff Working Document accompanies the Report from the Commission to the Council and the European Parliament – Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union. The report summarizes the data and conclusions presented in this Staff Working Document.

II.DATA SUBMITTED AND GENERAL ASSESSMENT

II.1.Data submitted by the Member States 

All 27 Member States submitted the data in the agreed EU format.

A quality control check on the set of data submitted for 2008 has been carried out and is essentially governed by four criteria based on certain relationships between the data in the different tables.

–The first of these relationships is the total number of animals used by species, column 1.2 of EU table 1, which is broken down into purposes of experiments in EU table 2. Thus, the totals of the Tables 1 and 2 should be identical.

–The second relationship concerns column 2.6 of EU table 2 'animals used for toxicological and other safety evaluation' which is broken down into types of products/endpoints in EU table 3; into Regulatory requirements in EU table 6; and into types of toxicological tests in EU table 7. Therefore, the total of column 2.6 must be equal to the totals of tables 3, 6, 7 and in addition table 8 'type of tests versus products' respectively.

–The third relationship is that the sum of column 2.4 and 2.5 of EU table 2 must be equal to the total of EU table 5.

–In the fourth relationship, the total of EU table 3 should be equal to the total of table 8.

The last criterion has shown obvious weaknesses when tested on the tables provided by the Member States and has lead to include an additional 5th quality check criterion.

–Fifth: each individual total in the total line of table 3 must be equal to each individual total in the total column of table 8 as the column headings are identical.

For this Sixth report all the above quality criteria have been fulfilled by the Member States. It is therefore considered that the data provided by the Member States affords a consistent base for a sound statistical analysis of all eight EU tables.

II.2.General assessment

Each Member State is requested, pursuant to Articles 13 of Directive 86/609/EEC, to submit to the Commission the statistical data on the animals used for experimental and other scientific purposes. The data for this report covers the year 2008 with the exception of France which provided data from 2007.

Council Resolution 86/C331/02 of the representatives of the Governments of the Member States of the European Communities, meeting within the Council of 24 November 1986 regarding the protection of animals used for experimental and other scientific purposes
[7](#footnote7)
 allows the use of animals in experiments for education and training, but where the purposes of such experiments are not covered by the Directive, Member States will according to the Resolution apply national provisions which are no less severe than those of the Directive. Therefore, a number of Member States have also included animals covered by the Resolution in the report.

The first part of this report aims at providing a comprehensive overview on the numbers of animals used for various experimental purposes in the Community in 2008. The purposes of the use of animals have been analysed, and some of these purposes have been broken down further into more precise parameters. It also considers different legislative requirements regarding the use of experimental animals and the type of testing carried out on different species.

As the two newest Member States, Bulgaria and Romania, have submitted data for the first time, it is in principle not possible to draw accurate quantitative conclusions on the evolution of the use of animals for experimental purposes in the EU by comparing data with those of the previous reports. However, as their total use amounts to less than 1% of the total number of animals used in 2008, some comparisons in trends have been attempted, and significant changes in use have been highlighted in the report.

The second part of this report provides the individual data from the Member States together with their respective comments and interpretations.

In the EU, the total number of animals used for experimental and other scientific purposes in 2008 in the Member States amounts to just over 12 million (with data from France from 2007).

As in previous reports rodents together with rabbits represent more than 80% of the total number of animals used in the EU. Mice are by far the most commonly used species accounting for 59% of the total use, followed by rats with 17%.

The second most used group of animals was, as in previous years, cold-blooded animals which represent almost 10%. The third largest group of animals used was birds with a little over 6% of the total use.

As stated in the previous two statistical reports no Great Apes were used in experiments in the EU in 2008.

II.3.Structure of the Report

The report is divided into two parts:

A
   A global compilation and overview for the European Union of the statistical data of the Member States for 2008.
   

A consolidated table has been computed on the basis of the data submitted by the Member States for each EU table and is presented at the end of each chapter. Each table is illustrated by a graphical presentation to give a more readable overview of the EU situation.

Similarly to results of the Report of 2005, for which France submitted statistical data for 2004, the data analysed for this Report includes statistical data from the year 2007 from France. Therefore, the totals used in this report are a mixture of years. Comparisons were nevertheless made on this basis since no other data were available.

The reader is invited to take note that the numbering of tables and graphical presentation in Part A of the report are linked to the numbers of the EU tables and not to the numbering of the chapters of the report.
   

B
   The data submitted by each Member State with a summary of the Member State’s comments.
   

PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2008

III.1.Results of EU Table 1: Species and number of animals

Two types of information can be drawn from the data submitted by the Member States in EU Table 1. The first relates to the total number of animals subdivided into 25 species used by the Member States. The second type of information relates to the place of origin of the animals used for experimental or other scientific purposes.

III.1.1.The data on the total number of animals used in the MS

Table 1.1 of this report presents the consolidated data on the number of animals used for experimental purposes, by species, submitted by 27 Member States. Whereas in previous years Malta had not used animals for scientific purposes, in 2008 this country reported animal use for the first time.

The total number of animals used in 2008 in the 27 Member States amounts to 12.0 million animals. It is important to note that the number of animals used in the new Member States who joined the EU in 2008 (Bulgaria and Romania) represents not even 1,0% of the total number of animals used in the EU 27.

III.1.2.Treatment and interpretation of the data of Table 1.1

In order to present an overall evaluation and subsequently a graphical analysis, animal species were grouped. The result of this exercise is presented in Table 1.2 at the end of this chapter. This grouping in Table 1.2 allows an overview of the species used and is illustrated in Figure 1.1.

It should also be pointed out that re-used animals are not included in the figures so that animals are not counted twice.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58002.jpg)

Rodents together with rabbits represent more than 80% of the total number of animals used. Mice (59,3%) and rats (17,6%) are by far the most commonly used species.

The second most used group is represented by cold-blooded animals namely reptiles, amphibians and fish at 9,6%.

Birds is the next highest animal group used for experimental purposes at 6,3%.

The Artiodactyla and Perissodactyla group including horses, donkeys and crossbreeds (Perrissodactyla), pigs, goats, sheep and cattle (Artiodactyla) represents 1,4% of the total number of animals used in the Member States.

Carnivores represent 0,3% of the total number of animals used and non-human primates represent 0,08% of the animals used in 2008.

III.1.3.Comparison with the data of the previous reports

In this chapter, and the following chapters where comparisons are addressed, the reader is invited to take note of the fact that in 1996, in 2002, in 2005 and for this report France has reported data respectively for 1997, 2001, 2004 and 2007 which does not allow a rigorous comparison between data reported for each year. Nevertheless, assuming that fluctuations in the annual numbers of animals used per species in a country are limited, it is possible to make semi-quantitative estimates of the observed trends by comparing changes in proportions of use, expressed as a percentage.

  

Comparison between proportions of classes of animals used in 1996, 1999, 2002, 2005 and 2008

|  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- |
| Class of species | 1996(\*) | 1999 | 2002(\*\*) | 2005(\*\*\*) | 2008(\*\*\*\*) |
| % Rodents-rabbits | 81,3 | 86,9 | 78,0 | 77,5 | 82,2, |
| % Cold-blooded animals | 12,9 | 6,6 | 15,4 | 15, | 9,6 |
| % Birds |  | 4,7 | 5 | 5,4 | 6,4 |
| % Artio and Perissodactyla |  | 1,2 | 1,2 | 1,1 | 1,4 |

(\*) 14 Member States reporting for 1996, one for 1997

(\*\*) 14 Member States reporting for 2002, one for 2001

(\*\*\*) 24 Member States reporting for 2005, one for 2004

(\*\*\*\*) 27 Member States reporting for 2008, one for 2007

Overall, the percentage of rodents and rabbits shows some fluctuation, but remains close to 80%. For cold-blooded animals the proportion used in 1996, in 2002 and 2005 is between 10 to 15%. In 2008 the use of cold-blooded animals has dropped considerably to below 10%. However, in 1999 a much lower percentage of 6,6% was observed.

Birds representing the third largest percentage of animals used, seems to be in constant increase over the years from 4 to 6,4%. The group of horses, donkeys and cross-bred animals (artiodactyla) and pigs, goats, sheep and cattle (perissodactyla) fluctuates at around 1%.

Contrary to what would have been expected, the effect of the inclusion of the data of new Member States since 2005 i.e. Bulgaria and Romania, did not lead to an increase in the total number of animals, on the contrary, there is a decrease of more than 116,500 animals.

Table 1.0 contains a comparison of the change that has taken place since 2008 for each species, expressed in number of animals per species, between EU 27 (data from 2008) and EU 25 (data from 2005) (first three columns) and in percentage per species (fourth column). The second half is a comparison between EU 25 (data of 2008 without Romania and Bulgaria)

  

Table 1.0 : Changes in species number and proportion between 2005 and 2008

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Species | Number of animals  in EU 25       2005 | Number of animals  in EU 27   2008 | Change since 2005 | % change by species | Change since 2005 | Number of animals  EU 25  2008  excl. RO,BG | % change by species |
| 1.a    Mice (Mus musculus) | 6430346 | 7122188 | 691842 | 9,71 | 630992 | 7061338 | 8,94 |
| 1.b    Rats (Rattus norvegicus) | 2336032 | 2121727 | -214305 | -10,10 | -223989 | 2112043 | -10,61 |
| 1.c    Guinea-Pigs (Cavia porcellus) | 257307 | 220985 | -36322 | -16,44 | -46774 | 210533 | -22,22 |
| 1.d    Hamsters (Mesocricetus ) | 31535 | 32739 | 1204 | 3,68 | 759 | 32294 | 2,35 |
| 1.e    Other Rodents (other Rodentia) | 64474 | 39506 | -24968 | -63,20 | -24968 | 39506 | -63,20 |
| 1.f    Rabbits (Oryctolagus cuniculus) | 312681 | 333213 | 20532 | 6,16 | 17514 | 330195 | 5,30 |
| 1.g    Cats (Felis catus) | 3898 | 4088 | 190 | 4,65 | 179 | 4077 | 4,39 |
| 1.h    Dogs (Canis familiaris) | 24119 | 21315 | -2804 | -13,16 | -2819 | 21300 | -13,23 |
| 1.i    Ferrets (Mustela putorius furo) | 2690 | 3208 | 518 | 16,15 | 518 | 3208 | 16,15 |
| 1.j    Other Carnivores | 8711 | 2853 | -5858 | -205,33 | -5858 | 2853 | -205,33 |
| 1.k    Horses, donkeys and cross breds (Equidae) | 5312 | 5976 | 664 | 11,11 | 633 | 5945 | 10,65 |
| 1.l    Pigs (Sus) | 66305 | 92813 | 26508 | 28,56 | 26369 | 92674 | 28,45 |
| 1.m    Goats (Capra) | 2146 | 3840 | 1694 | 44,11 | 1614 | 3760 | 42,93 |
| 1.n    Sheep (Ovis) | 30021 | 30190 | 169 | 0,56 | -212 | 29809 | -0,71 |
| 1.o    Cattle (Bos) | 36271 | 33952 | -2319 | -6,83 | -2448 | 33823 | -7,24 |
| 1.p    Prosimians (Prosimia) | 677 | 1261 | 584 | 46,31 | 584 | 1261 | 46,31 |
| 1.q    New World Monkeys (Ceboidea) | 1564 | 904 | -660 | -73,01 | -660 | 904 | -73,01 |
| -1.r    Old World Monkeys (Cercopithecoidea) | 8208 | 7404 | -804 | -10,86 | -804 | 7404 | -10,86 |
| 1.s    Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t    Other Mammals (other Mammalia) | 9950 | 5704 | -4246 | -74,44 | -4246 | 5704 | -74,44 |
| 1.u    Quail (Coturnix coturnix) | 9246 | 9626 | 380 | 3,95 | 371 | 9617 | 3,86 |
| 1.v    Other birds (other Aves) | 649813 | 754485 | 104672 | 13,87 | 101999 | 751812 | 13,57 |
| 1.w    Reptiles (Reptilia) | 2477 | 4101 | 1624 | 39,60 | 1624 | 4101 | 39,60 |
| 1.x    Amphibians (Amphibia) | 74620 | 61789 | -12831 | -20,77 | -17631 | 56989 | -30,94 |
| 1.y    Fish (Pisces) | 1749178 | 1087155 | -662023 | -60,89 | -662073 | 1087105 | -60,90 |
| 1.z    TOTAL | 12117583 | 12001022 | -116561 | -0,97 | -209328 | 11908255 | -1,76 |

There is an increase in the number of mice used since 2005 of 691,842 which is 9,71% of the total number of mice used in 2008 and a decrease for rats and fish. The largest change in 2008, increase in the use of mice, is almost entirely compensated for by the decrease in the use of fish.

The total number of pigs, goats, prosimians, and reptiles has increased by between 28 - 46%.

The total number of rats, guinea-pigs, other rodents, dogs, cattle and other mammals as well as amphibians and fish used has decreased substantially since the last report. When expressed in percentages these decreases range from more than 70% to around 10%.

The largest percentile change has, however, been noted in the decrease of the use of other carnivores. However, these species are not used in great numbers (from 8,711 to 2,853). There is also a large decrease of 75% in the total number of 'other mammals'.

It is also worth noting the large decrease in the use of new world monkeys of 73% as well as a decrease of 11% of old world monkeys. Prosimian use overall, however, has increased by 46%.

For species used in greater numbers, significant increases occurred in 2008 for mice, rabbits, pigs and 'other birds' where percentage changes ranged from 5% to 28%.

The following animals which are normally used in fewer numbers show an increase in use: ferrets (16%), horses, donkeys and cross-breeds (11%), goats (44%) and reptiles (39%).

As in 2002 and 2005, no great apes were used for experimental or other scientific purposes in 2008.

Member States provided examples of the type of species covered by category 'other' as follows:

Other rodents: gerbils, old world jerboas (Jaculus jaculus); chinchillas, beavers, ground squirrels, hamsters, grey dwarf hamsters (Cricetulus migratorius) and different species of mice.

Other carnivores: wild-life species used for zoological and ecological studies e.g. foxes, badgers, seals, otters and fitchew.

Other mammals: boars, bats and shrews, llamas, moles, European bison and red deer.

Other birds: mainly Japanese Quail (coturnix japonica) and bob-white quail, poultry species, and zebra finches, canaries, parakeets, parrots and farmed avian species for example, chickens.

In the three columns in the second half of the table, the addition of data from Bulgaria, Romania has virtually no effect on the proportional changes between the species.

Romania has little effect on the proportional changes between the species ranging from no change to very marginal variations per species. However, there is a net decrease of guinea pigs – 4%, and 10% for amphibians, when data from Bulgaria and Romania are excluded.

Table 1.1: Total number of animals used for experimental purposes in the EU Member States

Data of 2008 (\*)

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Species | AT | BE | BG | CY | CZ | DK | ET | FI | FR | DE | EL | HU | IE | IT | LV | LT | LU | MT | NL | PL | PT | RO | SP | SK | SL | SE | UK | Totals |
| 1a. Mice | 177544 | 480681 | 16265 | 2114 | 54776 | 168164 | 28754 | 78446 | 1561809 | 1314493 | 19786 | 158799 | 71224 | 553000 | 6912 | 3827 | 3280 | 50 | 237681 | 123897 | 39811 | 44585 | 543680 | 6942 | 10313 | 203112 | 1212243 | 7122188 |
| 1b. Rats | 9928 | 108580 | 4513 | 0 | 21531 | 75850 | 5268 | 26058 | 392773 | 390853 | 4367 | 89375 | 11741 | 230347 | 2407 | 1194 | 430 | 44 | 105780 | 45824 | 6571 | 5171 | 175325 | 9692 | 1675 | 53141 | 343289 | 2121727 |
| 1c. Guinea-Pigs | 3284 | 36554 | 3845 | 0 | 1902 | 5343 | 22 | 215 | 46030 | 35870 | 45 | 9743 | 91 | 13875 | 32 | 93 | 100 | 0 | 6062 | 6495 | 152 | 6607 | 12620 | 982 | 7 | 1766 | 29250 | 220985 |
| 1d. Hamsters | 693 | 2124 | 182 | 0 | 251 | 4 | 120 | 302 | 12063 | 7061 | 0 | 215 | 68 | 717 | 0 | 0 | 0 | 0 | 3358 | 312 | 29 | 263 | 1262 | 0 | 0 | 864 | 2851 | 32739 |
| 1e.Other Rodents | 47 | 1055 |  |  | 1233 | 1760 | 0 | 3142 | 3594 | 8392 |  | 356 |  | 1235 |  |  | 0 |  | 2439 | 11966 |  |  | 251 | 45 | 0 | 2033 | 1958 | 39506 |
| 1f. Rabbits | 18761 | 42025 | 813 | 0 | 6304 | 2931 | 630 | 814 | 96427 | 97938 | 1498 | 8134 | 204 | 9706 | 48 | 199 | 20 | 0 | 7418 | 3086 | 99 | 2205 | 19626 | 679 | 307 | 1332 | 12009 | 333213 |
| 1g. Cats | 2 | 78 | 11 | 0 | 45 | 154 | 0 |  | 1848 | 798 | 4 | 40 | 295 | 26 | 0 | 0 | 0 | 0 | 253 | 83 |  | 0 | 100 | 18 | 0 | 149 | 184 | 4088 |
| 1h. Dogs | 41 | 788 | 15 | 0 | 552 | 271 | 0 | 54 | 4131 | 4450 | 44 | 686 | 557 | 943 | 0 | 0 | 0 | 0 | 1244 | 230 |  | 0 | 1046 | 4 | 0 | 1982 | 4277 | 21315 |
| 1i. Ferrets | 14 | 324 | 0 | 0 | 122 | 117 | 0 |  | 800 | 55 | 0 | 0 |  | 0 | 0 | 0 | 0 | 0 | 472 | 0 |  | 0 | 287 | 0 | 0 | 39 | 978 | 3208 |
| 1j.Other Carnivores | 0 | 0 |  |  | 45 | 101 | 0 | 761 | 0 | 410 |  | 0 |  | 0 |  |  | 0 |  | 10 | 520 |  |  | 5 |  | 0 | 53 | 948 | 2853 |
| .k. horses, donkeys & cross-breeds | 47 | 62 | 17 |  | 378 | 54 | 0 | 37 | 652 | 584 | 1 | 40 | 144 | 46 |  |  | 0 |  | 2562 | 529 | 6 | 14 | 90 |  | 0 | 423 | 290 | 5976 |
| 1l. Pigs | 5086 | 2969 | 137 |  | 2013 | 6863 |  | 819 | 8768 | 12361 | 624 | 1193 | 224 | 3607 |  | 80 | 0 |  | 11729 | 11742 | 222 | 2 | 15121 | 22 | 3 | 1973 | 7255 | 92813 |
| 1m. Goats | 39 | 195 | 80 |  | 174 | 107 | 0 |  | 1159 | 531 | 24 | 92 |  | 41 |  |  | 0 |  | 229 | 300 |  |  | 372 | 5 | 0 | 5 | 487 | 3840 |
| 1n. Sheep | 142 | 356 | 250 |  | 1148 | 88 |  | 571 | 3573 | 4638 | 68 | 200 | 456 | 469 |  |  | 0 |  | 3486 | 2217 | 28 | 131 | 2386 | 9 | 4 | 152 | 9818 | 30190 |
| 1o. Cattle | 574 | 657 | 126 |  | 799 | 939 | 0 | 300 | 3206 | 6252 | 72 | 93 | 4019 | 462 |  |  | 0 |  | 2236 | 7540 | 10 | 3 | 1091 |  | 0 | 1379 | 4194 | 33952 |
| 1p. Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 718 | 543 | 0 | 0 |  | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 0 | 0 | 0 | 0 | 0 | 0 | 1261 |
| 1q.N W Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 233 | 305 | 0 | 5 |  | 18 | 0 | 0 | 0 | 0 | 73 | 0 |  | 0 | 8 | 0 | 0 | 0 | 262 | 904 |
| 1r.O W Monkeys | 0 | 41 | 0 | 0 | 80 | 0 | 0 |  | 1797 | 1415 | 0 | 1 |  | 344 | 0 | 0 | 0 | 0 | 82 | 0 |  | 0 | 517 | 0 | 0 | 35 | 3092 | 7404 |
| 1s. Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 0 | 0 | 0 | 0 |  | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ..t.Other Mammals | 0 | 151 |  |  | 1774 | 243 |  | 84 | 0 | 541 |  | 16 | 32 | 151 |  |  | 0 |  | 202 | 1246 |  |  | 28 | 21 | 0 | 263 | 952 | 5704 |
| 1u. Quail | 14 | 431 | 0 | 0 | 0 | 0 | 0 |  | 1548 | 1803 | 0 | 13 |  | 249 | 0 | 0 | 0 | 0 | 0 | 5100 |  | 9 | 138 | 120 | 0 | 201 | 0 | 9626 |
| 1v. Other birds | 1367 | 17151 | 1477 |  | 148722 | 2820 |  | 5568 | 156814 | 53986 | 88 | 32554 | 582 | 32241 |  | 40 | 0 |  | 90890 | 27391 | 160 | 1196 | 52104 | 696 | 129 | 3432 | 125077 | 754485 |
| 1w. Reptiles | 17 | 374 |  |  | 1012 | 221 |  | 317 | 758 | 192 |  | 108 |  | 454 |  |  | 0 |  | 121 | 248 |  |  |  |  | 0 | 170 | 109 | 4101 |
| 1x. Amphibians | 277 | 2388 | 4800 |  | 3016 | 293 |  | 34 | 9451 | 10815 | 200 | 1182 |  | 2432 |  | 149 | 0 |  | 870 | 1221 |  |  | 704 |  | 0 | 641 | 23316 | 61789 |
| 1y. Fish | 2579 | 28386 | 50 |  | 54836 | 31245 |  | 21078 | 20228 | 67496 | 1200 | 2077 | 23198 | 13955 |  |  | 0 | 600 | 23859 | 25941 | 3800 |  | 71098 | 25 | 0 | 211459 | 484045 | 1087155 |
| 1z.TOTAL | 220456 | 725370 | 32581 | 2114 | 300713 | 297568 | 34794 | 138600 | 2328380 | 2021782 | 28021 | 304922 | 112835 | 864318 | 9399 | 5582 | 3830 | 694 | 501056 | 275888 | 50888 | 60186 | 897859 | 19260 | 12438 | 484604 | 2266884 | 12001022 |

(\*) France is reporting for 2007

Table 1.2: Classes of animals used for experimental purposes in the EU Member States

Data of 2008 (\*)

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Species | AT | BE | BG | CY | CZ | DK | ET | FI | FR | DE | EL | HU | IE | IT | LV | LT | LU | MT | NL | PL | PT | RO | SP | SK | SL | SE | UK | Totals |
| Mice | 177544 | 480681 | 16265 | 2114 | 54776 | 168164 | 28754 | 78446 | 1561809 | 1314493 | 19786 | 158799 | 71224 | 553000 | 6912 | 3827 | 3280 | 50 | 237681 | 123897 | 39811 | 44585 | 543680 | 6942 | 10313 | 203112 | 1212243 | 7122188 |
| Rats | 9928 | 108580 | 4513 | 0 | 21531 | 75850 | 5268 | 26058 | 392773 | 390853 | 4367 | 89375 | 11741 | 230347 | 2407 | 1194 | 430 | 44 | 105780 | 45824 | 6571 | 5171 | 175325 | 9692 | 1675 | 53141 | 343289 | 2121727 |
| Guinea-Pigs | 3284 | 36554 | 3845 | 0 | 1902 | 5343 | 22 | 215 | 46030 | 35870 | 45 | 9743 | 91 | 13875 | 32 | 93 | 100 | 0 | 6062 | 6495 | 152 | 6607 | 12620 | 982 | 7 | 1766 | 29250 | 220985 |
| Hamsters + other rodents | 740 | 3179 | 182 | 0 | 1484 | 1764 | 120 | 3444 | 15657 | 15453 | 0 | 571 | 68 | 1952 | 0 | 0 | 0 | 0 | 5797 | 12278 | 29 | 263 | 1513 | 45 | 0 | 2897 | 4809 | 72245 |
| Rabbits | 18761 | 42025 | 813 | 0 | 6304 | 2931 | 630 | 814 | 96427 | 97938 | 1498 | 8134 | 204 | 9706 | 48 | 199 | 20 | 0 | 7418 | 3086 | 99 | 2205 | 19626 | 679 | 307 | 1332 | 12009 | 333213 |
| Cold-blooded animals (1) | 2873 | 31148 | 4850 | 0 | 58864 | 31759 | 0 | 21429 | 30437 | 78503 | 1400 | 3367 | 23198 | 16841 | 0 | 149 | 0 | 600 | 24850 | 27410 | 3800 | 0 | 71802 | 25 | 0 | 212270 | 507470 | 1153045 |
| Birds (2) | 1381 | 17582 | 1477 | 0 | 148722 | 2820 | 0 | 5568 | 158362 | 55789 | 88 | 32567 | 582 | 32490 | 0 | 40 | 0 | 0 | 90890 | 32491 | 160 | 1205 | 52242 | 816 | 129 | 3633 | 125077 | 764111 |
| Artio+perissodactyla (3) | 5888 | 4239 | 610 | 0 | 4512 | 8051 | 0 | 1727 | 17358 | 24366 | 789 | 1618 | 4843 | 4625 | 0 | 80 | 0 | 0 | 20242 | 22328 | 266 | 150 | 19060 | 36 | 7 | 3932 | 22044 | 166771 |
| Carnivores | 57 | 1190 | 26 | 0 | 764 | 643 | 0 | 815 | 6779 | 5713 | 48 | 726 | 852 | 969 | 0 | 0 | 0 | 0 | 1979 | 833 | 0 | 0 | 1438 | 22 | 0 | 2223 | 6387 | 31464 |
| Prosimians+monkeys  +apes | 0 | 41 | 0 | 0 | 80 | 0 | 0 | 0 | 2748 | 2263 | 0 | 6 | 0 | 362 | 0 | 0 | 0 | 0 | 155 | 0 | 0 | 0 | 525 | 0 | 0 | 35 | 3354 | 9569 |
| Other mammals | 0 | 151 |  |  | 1774 | 243 |  | 84 | 0 | 541 |  | 16 | 32 | 151 |  |  | 0 |  | 202 | 1246 |  |  | 28 | 21 | 0 | 263 | 952 | 5704 |
|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| TOTAL | 220456 | 725370 | 32581 | 2114 | 300713 | 297568 | 34794 | 138600 | 2328380 | 2021782 | 28021 | 304922 | 112835 | 864318 | 9399 | 5582 | 3830 | 694 | 501056 | 275888 | 50888 | 60186 | 897859 | 19260 | 12438 | 484604 | 2266884 | 12001022 |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Species % | AT | BE | BG | CY | CZ | DK | ET | FI | FR | DE | EL | HU | | IE | IT | LV | LT | LU | MT | NL | PL | PT | RO | SP | SK | SL | SE | UK | Totals |
| Mice | 80,53 | 66,27 | 49,92 | 100,00 | 18,22 | 56,51 | 82,64 | 56,60 | 67,08 | 65,02 | 70,61 | 52,08 | | 63,12 | 63,98 | 73,54 | 68,56 | 85,64 | 7,20 | 47,44 | 44,91 | 78,23 | 74,08 | 60,55 | 36,04 | 82,92 | 41,91 | 53,48 | 59,35 |
| Rats | 4,50 | 14,97 | 13,85 | 0,00 | 7,16 | 25,49 | 15,14 | 18,80 | 16,87 | 19,33 | 15,58 | 29,31 | | 10,41 | 26,65 | 25,61 | 21,39 | 11,23 | 6,34 | 21,11 | 16,61 | 12,91 | 8,59 | 19,53 | 50,32 | 13,47 | 10,97 | 15,14 | 17,68 |
| Guinea-Pigs | 1,49 | 5,04 | 11,80 | 0,00 | 0,63 | 1,80 | 0,06 | 0,16 | 1,98 | 1,77 | 0,16 | 3,20 | | 0,08 | 1,61 | 0,34 | 1,67 | 2,61 | 0,00 | 1,21 | 2,35 | 0,30 | 10,98 | 1,41 | 5,10 | 0,06 | 0,36 | 1,29 | 1,84 |
| Hamsters + other rodents | 0,34 | 0,44 | 0,56 | 0,00 | 0,49 | 0,59 | 0,34 | 2,48 | 0,67 | 0,76 | 0,00 | 0,19 | | 0,06 | 0,23 | 0,00 | 0,00 | 0,00 | 0,00 | 1,16 | 4,45 | 0,06 | 0,44 | 0,17 | 0,23 | 0,00 | 0,60 | 0,21 | 0,60 |
| Rabbits | 8,51 | 5,79 | 2,50 | 0,00 | 2,10 | 0,98 | 1,81 | 0,59 | 4,14 | 4,84 | 5,35 | 2,67 | | 0,18 | 1,12 | 0,51 | 3,57 | 0,52 | 0,00 | 1,48 | 1,12 | 0,19 | 3,66 | 2,19 | 3,53 | 2,47 | 0,27 | 0,53 | 2,78 |
| Cold-blooded animals (1) | 1,30 | 4,29 | 14,89 | 0,00 | 19,57 | 10,67 | 0,00 | 15,46 | 1,31 | 3,88 | 5,00 | 1,10 | | 20,56 | 1,95 | 0,00 | 2,67 | 0,00 | 86,46 | 4,96 | 9,94 | 7,47 | 0,00 | 8,00 | 0,13 | 0,00 | 43,80 | 22,39 | 9,61 |
| Birds (2) | 0,63 | 2,42 | 4,53 | 0,00 | 49,46 | 0,95 | 0,00 | 4,02 | 6,80 | 2,76 | 0,31 | 10,68 | | 0,52 | 3,76 | 0,00 | 0,72 | 0,00 | 0,00 | 18,14 | 11,78 | 0,31 | 2,00 | 5,82 | 4,24 | 1,04 | 0,75 | 5,52 | 6,37 |
| Artio+perissodactyla (3) | 2,67 | 0,58 | 1,87 | 0,00 | 1,50 | 2,71 | 0,00 | 1,25 | 0,75 | 1,21 | 2,82 | 0,53 | | 4,29 | 0,54 | 0,00 | 1,43 | 0,00 | 0,00 | 4,04 | 8,09 | 0,52 | 0,25 | 2,12 | 0,19 | 0,06 | 0,81 | 0,97 | 1,39 |
| Carnivores | 0,03 | 0,16 | 0,08 | 0,00 | 0,25 | 0,22 | 0,00 | 0,59 | 0,29 | 0,28 | 0,17 | 0,24 | | 0,76 | 0,11 | 0,00 | 0,00 | 0,00 | 0,00 | 0,39 | 0,30 | 0,00 | 0,00 | 0,16 | 0,11 | 0,00 | 0,46 | 0,28 | 0,26 |
| Prosimians+monkeys+  apes | 0,00 | 0,01 | 0,00 | 0,00 | 0,03 | 0,00 | 0,00 | 0,00 | 0,12 | 0,11 | 0,00 | 0,00 | | 0,00 | 0,04 | 0,00 | 0,00 | 0,00 | 0,00 | 0,03 | 0,00 | 0,00 | 0,00 | 0,06 | 0,00 | 0,00 | 0,01 | 0,15 | 0,08 |
| Other mammals | 0,00 | 0,02 | 0,00 | 0,00 | 0,59 | 0,08 | 0,00 | 0,06 | 0,00 | 0,03 | 0,00 | 0,01 | | 0,03 | 0,02 | 0,00 | 0,00 | 0,00 | 0,00 | 0,04 | 0,45 | 0,00 | 0,00 | 0,00 | 0,11 | 0,00 | 0,05 | 0,04 | 0,05 |
| Mice |  |  |  |  |  |  |  |  |  |  |  |  | |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| TOTAL | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| FR(\*) France reporting for 2007 | | | | | | | | | | | | |
| (1) reptiles + amphibians + fish | | | | | | | | | | | | |
| (2) Quails and other birds | | | | | | | | | | | | |
| (3) Horses, donkeys, and cross breeds + pigs + goats and sheep +cattle | | | | | | | | | | | | |
| (4) Cats + dogs + ferrets + other carnivores | | | | | | | | | | | | |

III.2.Results of EU Table 1: Origin of animals used

III.2.1.The data on the origin of the species

The consolidated results of EU Table 1 on the origin of some selected species used for experimental purposes in the 27 Member States are reported in Table 1.3 at the end of this chapter. The consolidated table 1.3 only indicates species for which the origin must be reported.

In addition, EU Table 1.3 contains information on the number of animals re-used in experiments.

III.2.2.Treatment and interpretation of the data

The data of column 1.3 and 1.4 of Table 1.3 of this report have been grouped to represent animals coming from the European Union.

Figure 1.2 represents the percentage of animals from the reported origin versus the species.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58003.jpg)

The chart shows clearly that the majority of the species originated from EU countries. However, certain species such as cats, dogs and ferrets and old world monkeys are also of non-European origin.

III.2.3.Comparison with data of the previous report

The general pattern on the origin of the species is quite similar to that observed in previous reports. It should be noted however, that for the first time in 2005 the prosimians were all of EU origin and remain so for this report. A similar trend can also be observed with the new world monkeys where almost all originate from either EU Member States or countries which are a party to the Council of Europe Convention ETS 123. Finally, also old world monkeys coming from the EU increased from about 26% in 2005 to more than 50% in 2008. On the other hand the number of cats of EU origin also increased whereas dogs and ferrets of non-European origin have remained unchanged since the last report.

Table 1.3: Number of animals used in relation to their place of origin

Data of 2008 (\*)

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1Species | 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) | 7122188 | 6042205 | 900230 | | 21382 | | 158371 | | 3768 | |
| 1.b. Rats (Rattus norvegicus) | 2121727 | 1761785 | 329385 | | 9844 | | 20713 | | 3035 | |
| 1.c. Guinea-Pigs (Cavia porcellus) | 220985 | 161973 | 56167 | | 2051 | | 792 | | 962 | |
| 1.d. Hamsters (Mesocricetus ) | 32739 | 24999 | 5476 | | 1074 | | 1190 | | 54 | |
| 1.f. Rabbits (Oryctolagus cuniculus) | 333213 | 315006 | 14753 | | 364 | | 3087 | | 15958 | |
| 1.g. Cats (Felis catus) | 4088 | 2306 | 726 | | 14 | | 1042 | | 1181 | |
| 1.h. Dogs (Canis familiaris) | 21315 | 12467 | 2885 | | 309 | | 5654 | | 4178 | |
| 1.i. Ferrets (Mustela putorius furo) | 3208 | 1847 | 442 | | 0 | | 919 | | 64 | |
| 1.p. Prosimians (Prosimia) | 1261 | 718 | 543 | | 0 | | 0 | | 33 | |
| 1.q. New World Monkeys (Ceboidea) | 904 | 816 | 83 | | 5 | | 0 | | 346 | |
| 1.r. Old World Monkeys (Cercopithecoidea) | 7404 | 3213 | 850 | | 5 | | 3336 | | 1509 | |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | | 0 | | 0 | | 0 | |
| 1.u. Quail (Coturnix coturnix) | 9626 | 7824 | 1500 | | 0 | | 302 | | 0 | |
| 1.z. TOTAL | 9878658 | 8335159 | 1313040 | | 35048 | | 195406 | |  | |
|  |  |  |  | |  | |  | |  | |
| \* France: data of 2007 |  |  |  | |  | |  | |  | |
|  |  |  |  | |  | |  | |  | |
| Note 1: Column 1.5 concerns only those member countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling this column | | | | | | | | | | |
| Note 2: Only species for which the origin has to be reported are included in this table | | | |  | |  | |  | |  |
| Note 3: The number of re-used animals in column 1.7 should be excluded from the total in column 1.2. | | | | | |  | |  | |  |

III.3.Results of EU Table 2: Purposes of the experiments

III.3.1.The data on purposes of the experiments

The consolidated data on purposes of the experiments of the 27 Member States are presented in Table 2.1 at the end of this chapter.

III.3.2.Treatment and interpretation of the data

Table 2.2 presents the results of the consolidated data of the purposes of the procedures carried out in the 27 Member States in 2008. In order to facilitate the presentation of results some species and some purposes were grouped in Table 2.2.

The percentage of the number of animals used for selected purposes is presented in Figure 2.1.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58004.jpg)

More than 60% of animals were used in research and development for human medicine, veterinary medicine, dentistry and in fundamental biological studies.

Production and quality control of products and devices in human medicine, veterinary medicine and dentistry required the use of 14,9% of the total number of animals.

Toxicological and other safety evaluation represents 8,7% of the total number of animals used for experimental purposes.

Other purposes of procedures represents 12% of the total number of animals and covers a wide range of experiments such as virology, immunology for production of monoclonal and polyclonal antibodies, physiology of foetal-maternal interaction in mouse gene transgensis, oncological treatment, pharmaceutical research and development, combined drug testing and genetics.

III.3.3.Comparison with the data of the previous report

The comparison aims to detect changes in trends rather than draw formal conclusions. The most significant change that has taken place since 2005 is that the number of animals used for research and development for human medicine, dentistry and veterinary medicine has dropped sharply from 31% to 22,8% (in terms of animal numbers the decrease is from 3,746,028 to 2,733,706). To be noted in particular is the significant reduction of more than 800,000 cold-blooded animals since the last report of 2005. On the other hand, the percentage of animals used for fundamental biological research has increased from 33% to 38% (that is, from 4,035,470 to 4,575,054) as well as for 'other purposes', from 8% to 12%. It should be underlined that both fundamental biology and research and development in human and veterinary medicine are the areas using by far the highest number of animals for experimental purposes in the EU.

The number of animals used for toxicological and other safety evaluation has remained virtually unchanged since the last report and amounts to 8,7% of the total number of animals used for experimental purposes in the EU. This represents 1,042,153 animals.

In general the number of animals used for production and quality control of devices for medicine, veterinary medicine and dentistry has also remained unchanged since 2005. However, regarding the use by species, the use of mice and rabbits has increased substantially for production and quality control of products and devices for human medicine and dentistry. One Member State indicated that funding had been made available for pre-clinical trials for human medicine, which lead to an increase in use of experimental animals.

Another Member State using a large number of rabbits for production and quality control of veterinary medicine indicated that the laboratory responsible for that increase had reported the data in the wrong column, that is, they should have been reported under production and quality control of human medicine and dentistry rather than for products and devices for veterinary medicine. The increase was due to the production of polyclonal antibodies to improve transplant in human medicine. However, it was no longer possible to correct the error in the consolidated report.

Regarding increases in other purposes of use, there is a substantial increase in the use of mice, pigs and birds for 'fundamental biological research' and in 'other experiments'.

Several Member States confirmed that the increase in the use of mice for fundamental biological research is attributed to the new research possibilities offered by the transgenic species. These animal models are being used both for human and animal health studies. An increase was also reported for the purpose of experiments in anatomy and developmental biology, physiology, genetics and cancer research, and for immunology and microbiology.

There are several reasons for the increase in the use of pigs in ‘fundamental biological’ and also in ‘other studies’. One Member State using a large number of pigs for fundamental biological studies and for other procedures indicated that in recent years funding for projects relating to cardiovascular research has increased significantly. The same applies in the case of experimental surgery which is taking place in many hospitals in the same Member State. Another area using an increased number of pigs relates to pig disease studies, including for example the observation of vaccine effectiveness. It was reported that the increase was also due to fundamental research on pigs’ enzymes and digestive functions, and because the tissues and organs of transgenic pigs are used for transplants in humans.

The large number of birds used for fundamental biological research in one Member State was due to a campaign of bird ringing. The increase of the number of birds used for 'other experiments' was reported to be due to parasitology/immunology studies and to the development of genetically modified birds.

Table 2.2: Number of animals used for selected purposes versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Species | Biological studies of a fundamental nature | Research,development and quality control of products and devices for human medicine and dentistry and for veterinary medicine | Toxicological and other safety evaluations (including safety evaluation of products) | Diagnosis of disease | Education and training | Other | Total |
| Mice | 3080775 | 2624856 | 398199 | 137578 | 82606 | 798174 | 7122188 |
| Rats | 595542 | 1060290 | 294683 | 22997 | 59412 | 88803 | 2121727 |
| Other rodents | 44240 | 195427 | 33858 | 3145 | 7826 | 8734 | 293230 |
| Rabbits | 17813 | 212618 | 39987 | 3376 | 3326 | 56093 | 333213 |
| Carnivores | 4804 | 11378 | 11964 | 1360 | 515 | 1443 | 31464 |
| Artio+perissodactyla | 55080 | 56359 | 8996 | 4620 | 13134 | 28582 | 166771 |
| Prosimians+monkeys+apes | 1213 | 1260 | 6507 | 153 | 10 | 426 | 9569 |
| Other mammals | 5279 | 177 | 0 | 12 | 25 | 211 | 5704 |
| Birds | 292895 | 247618 | 53477 | 8415 | 11444 | 150262 | 764111 |
| Cold-blooded animals | 477413 | 113766 | 194482 | 3651 | 29159 | 334574 | 1153045 |
| TOTAL | 4575054 | 4523749 | 1042153 | 185307 | 207457 | 1467302 | 12001022 |

Figure 2.2 presents the number of animals used for selected purposes by classes of species.

The highest number of mice and rats is attributed to fundamental biological studies and research, development and quality control of products and devices for medicine, dentistry and veterinary medicine. It is noteworthy that a high number of cold-blooded animals have been used for 'other purposes' as well as for 'biological studies of a fundamental nature'.

One can observe a significant reduction in the use of cold-blooded animals for research and development of devices for human and veterinary medicine and for dentistry since the last report of 2005.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58005.jpg)

Table 2.1: Number of animals used in experiments for selected purposes 
  
Purposes versus species
  
data of 2008\*

|  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1.Species | 2.2.Biological studies of a fundamental nature | 2.3. Research and development of products and devices for human medicine and dentistry and for veterinary medicine(excluding toxicological and other safety evaluations counted in column 2.6) | 2.4. Production and quality control of products and devices for human medicine and dentistry | 2.5. Production and quality control of products and devices for veterinary medicine | 2.6. Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine | 2.7. Diagnosis of disease | 2.8. Education and training | 2.9. Other | 2.10. Total |
| 1.a. Mice (Mus musculus) | 3080775 | 1597381 | 856048 | 171427 | 398199 | 137578 | 82606 | 798174 | 7122188 |
| 1.b. Rats (Rattus norvegicus) | 595542 | 840909 | 181140 | 38241 | 294683 | 22997 | 59412 | 88803 | 2121727 |
| 1.c. Guinea-Pigs (Cavia porcellus) | 10632 | 44344 | 103852 | 17265 | 31883 | 1940 | 5804 | 5265 | 220985 |
| 1.d. Hamsters (Mesocricetus ) | 6994 | 8041 | 376 | 12513 | 1580 | 278 | 520 | 2437 | 32739 |
| 1.e. Other Rodents (other Rodentia) | 26614 | 9006 | 30 | 0 | 395 | 927 | 1502 | 1032 | 39506 |
| 1.f. Rabbits (Oryctolagus cuniculus) | 17813 | 29764 | 131031 | 51823 | 39987 | 3376 | 3326 | 56093 | 333213 |
| 1.g. Cats (Felis catus) | 560 | 1738 | 57 | 679 | 322 | 124 | 97 | 514 | 4091 |
| 1.h. Dogs (Canis familiaris) | 1814 | 4405 | 157 | 2070 | 11077 | 1111 | 362 | 316 | 21312 |
| 1.i. Ferrets (Mustela putorius furo) | 551 | 1287 | 564 | 8 | 269 | 45 | 56 | 428 | 3208 |
| 1.j. Other Carnivores (other Carnivora) | 1879 | 75 | 0 | 338 | 296 | 80 | 0 | 185 | 2853 |
| 1.k. Horses, donkeys and cross breds (Equidae) | 1402 | 728 | 224 | 2559 | 22 | 239 | 489 | 313 | 5976 |
| 1.l. Pigs (Sus) | 23531 | 22799 | 423 | 9001 | 8065 | 1452 | 8134 | 19408 | 92813 |
| 1.m. Goats (Capra) | 1098 | 721 | 93 | 26 | 43 | 90 | 422 | 1347 | 3840 |
| 1.n. Sheep (Ovis) | 9727 | 4098 | 6020 | 2149 | 409 | 1616 | 1243 | 4928 | 30190 |
| 1.o. Cattle (Bos) | 19322 | 3990 | 214 | 3314 | 457 | 1223 | 2846 | 2586 | 33952 |
| 1.p. Prosimians (Prosimia) | 568 | 0 | 0 | 0 | 543 | 150 | 0 | 0 | 1261 |
| 1.q. New World Monkeys (Ceboidea) | 235 | 235 | 33 | 0 | 270 | 0 | 0 | 131 | 904 |
| 1.r. Old World Monkeys (Cercopithecoidea) | 410 | 761 | 231 | 0 | 5694 | 3 | 10 | 295 | 7404 |
| 1.s. Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. Other Mammals (other Mammalia) | 5279 | 86 | 28 | 63 | 0 | 12 | 25 | 211 | 5704 |
| 1.u. Quail (Coturnix coturnix) | 5520 | 57 | 0 | 0 | 2170 | 9 | 1575 | 295 | 9626 |
| 1.v. Other birds (other Aves) | 287375 | 77748 | 10593 | 159220 | 51307 | 8406 | 9869 | 149967 | 754485 |
| 1.w. Reptiles (Reptilia) | 3781 | 94 | 0 | 0 | 0 | 0 | 147 | 79 | 4101 |
| 1.x. Amphibians (Amphibia) | 32780 | 1914 | 0 | 0 | 291 | 202 | 12213 | 14389 | 61789 |
| 1.y. Fish (Pisces) | 440852 | 83525 | 20418 | 7815 | 194191 | 3449 | 16799 | 320106 | 1087155 |
| 1.z. TOTAL | 4575054 | 2733706 | 1311532 | 478511 | 1042153 | 185307 | 207457 | 1467302 | 12001022 |

(\*) France is reporting for 2007

III.4.Results of EU Table 3: Toxicological and safety evaluation by type of product/endpoint

III.4.1.The data on toxicological and safety evaluation by type of product/endpoint

The consolidated table giving the number of animals used for toxicological and other safety evaluation of products (EU Table 3) in 27 Member States in 2008 is presented in Table 3.1 at the end of this chapter. In table 3.1 the number of animals used for toxicological or other safety evaluation is broken down into types of products for which testing was required.

The percentage of the number of animals used for different types of product is presented in Figure 3.

III.4.2.Treatment and interpretation of the data

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58006.jpg)

The number of animals used for toxicological and other safety evaluation for different products or environmental test schemes amounts to 1,042,153, which represents 8,7% of the total number of animals used for experimental purposes in 2008 (see Table 2.1, column 2.6).

Toxicological or other safety evaluations are split up according to the type of sector for which they are intended. The percentage of animals used for toxicological evaluation of three groups of products/substances, i.e. additives in food for human consumption, cosmetics and household products, is very small (1,18%) when compared to the other product groups.

Products or devices used for human medicine, veterinary medicine and dentistry represents 50,8% of the animals used for toxicological or other safety evaluations.

The group of products/substances falling under the scrutiny of Member States authorities concerned with safety of health and of the environment by chemical products, such as industrial chemicals and pesticides, used 15% of the animals for toxicological and other safety evaluations.

There is a clear decrease in the number of animals used for toxicological tests for products intended for industry, for agriculture and for potential contaminants of the environment. The decrease ranges respectively from above 96,000 to about 82,000; from below 98,000 to about 74,000 and from above 84,000 to about 65,000 in comparison to the data submitted in the 2005 statistical report.

There is also a significant decrease in the number of animals used for testing of products for cosmetics and toiletries ranging from 5,500 to just below 2,000 (a 65% drop). This change has to be seen in light of the legal requirement to phase out animal testing for cosmetics in the EU where a ban on testing has been applicable since 2009 for all human health effects with the exception of three toxicological end-points: repeated-dose toxicity, reproductive toxicity and toxicokinetics. The year 2013 is the deadline for a marketing ban for cosmetics tested for these remaining specific health effects.

There is however also a significant increase since 2005 in the number of animals used for tests for additives in food for animal consumption (from 34,225 to 54,164). This may reflect the animal feed sanitary concerns expressed in the EU after the discovery of harmful contaminants in such products over the last 10 years.

It should also be noted that in comparison to the 2005 report, there is a significant increase in the number of animals used for ‘other’ toxicological or safety evaluation (ranging from around 180,000 to about 220,000). Member States reported that this particular use of animals concerned new methods and tests, such as tests on transmission of microcystins on embryonic membrane, bioassays, toxicity evaluation for humans via the environment, and control of safety of toys.

Table 3.1: Number of animals used in toxicological and other safety evaluation
  
Products versus species

Data of 2008\*

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1.Species | 3.2. Products/ substances or devices for human medicine and dentistry and for veterinary medicine | 3.3. Products/ substances used or intended to be used mainly in agriculture | 3.4.Products/ substances used or intended to be used mainly in industry | 3.5.Products/ substances used or intended to be used mainly in the household | 3.6.Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7.Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8.Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9.Potential or actual contaminants in the general environment which do not appear in other columns | 3.10.Other toxicological or safety evaluations | 3.11.Total |
| 1.a.    Mice (Mus musculus) | 188227 | 10129 | 20249 | 1922 | 880 | 2818 | 1680 | 9433 | 162919 | 398257 |
| 1.b.    Rats (Rattus norvegicus) | 187283 | 31421 | 41562 | 1709 | 174 | 2764 | 303 | 2932 | 26496 | 294644 |
| 1.c.    Guinea-Pigs (Cavia porcellus) | 23152 | 2830 | 3679 | 0 | 38 | 24 | 7 | 0 | 2192 | 31922 |
| 1.d.    Hamsters (Mesocricetus ) | 1559 | 0 | 21 | 0 | 0 | 0 | 0 | 0 | 0 | 1580 |
| 1.e.    Other Rodents (other Rodentia) | 0 | 164 | 0 | 0 | 0 | 0 | 0 | 204 | 27 | 395 |
| 1.f.    Rabbits (Oryctolagus cuniculus) | 30516 | 2696 | 4453 | 50 | 153 | 11 | 7 | 12 | 2127 | 40025 |
| 1.g.    Cats (Felis catus) | 312 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 322 |
| 1.h.    Dogs (Canis familiaris) | 9888 | 340 | 16 | 0 | 0 | 0 | 0 | 0 | 833 | 11077 |
| 1.i.    Ferrets (Mustela putorius furo) | 269 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 269 |
| 1.j.    Other Carnivores (other Carnivore) | 296 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 296 |
| 1.k.    Horses, donkeys and cross breds (Equidae) | 22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 22 |
| 1.l.    Pigs (Sus) | 3169 | 90 | 0 | 0 | 0 | 100 | 4584 | 64 | 66 | 8073 |
| 1.m.    Goats (Capra) | 21 | 14 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 43 |
| 1.n.    Sheep (Ovis) | 408 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 409 |
| 1.o.    Cattle (Bos) | 409 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 44 | 457 |
| 1.p.    Prosimians (Prosimia) | 543 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 543 |
| 1.q.    New World Monkeys (Ceboidea) | 200 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 70 | 270 |
| 1.r.    Old World Monkeys (Cercopithecoidea) | 5121 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 573 | 5694 |
| 1.s.    Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t.    Other Mammals (other Mammalia) | 0 | 210 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 210 |
| 1.u.    Quail (Coturnix coturnix) | 64 | 2110 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2174 |
| 1.v.    Other birds (other Aves) | 8838 | 2116 | 30 | 0 | 0 | 0 | 39553 | 97 | 320 | 50954 |
| 1.w.    Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x.    Amphibians (Amphibia) | 179 | 108 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 291 |
| 1.y.    Fish (Pisces) | 69021 | 21915 | 12416 | 601 | 722 | 523 | 8030 | 53062 | 27936 | 194226 |
| 1.z.    TOTAL | 529497 | 74147 | 82426 | 4282 | 1967 | 6240 | 54164 | 65812 | 223618 | 1042153 |

(\*) France reporting for 2007

III.5.Results of EU Table 4: Animals used for studies of diseases 

III.5.1.The data on animals used for studies of diseases

The consolidated table of results on animals used for studies of diseases (EU Table 4) in the 27 Member States is presented in Table 4.1 at the end of this chapter.

III.5.2.Treatment and interpretation of the data

Table 4.1 gives the number of animals used per type of studies on diseases.

In 2008 the number of animals used for the study of both animal and human diseases represented about 6,322,000 animals which is more than half (52%) the total number of animals used for experimental purposes in the EU.

Figure 4.1 presents the percentage of animals used in studies per type of diseases.

The proportion of animals used for studies of human diseases represents more than 90% of the total number of animals used for all disease studies.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58007.jpg)

Overall in 2008 there is a 50% decrease in the number of animals used for studies on specific animal diseases - from 1,329,000 to 614,000. In particular, a significant change occurred in the use of cold-blooded species where figures decreased from around 954,000 animals in 2005 to 43,914 in 2008.

Interesting to note is that despite the overall decrease, the use of mice increased substantially in 2008. Around 35% of the increase (about 681,000) can be attributed to different studies of diseases (see also observations under chapter III.3.3).

Some Member States confirmed that the increase of the use of animals in general, or mice in particular in table 4, is also reported under several headings of table 2, such as fundamental biological research and research and development of products for human and veterinary medicine and even production and control process for human and veterinary medicine. For the 2008 data one Member States indicated, however, that the increase of use of mice was primarily attributed to fundamental biological research.

It should be remembered that the studies on specific animal diseases are important in light of epidemic diseases affecting animals such as in the case of foot and mouth disease, swine fever and more recently avian flew. However, animals have also been used in studies on genetic diseases. According to 2008 data there has been more than a 50% reduction in animals used for studies on animal diseases. This could be because there have been no new significant animal disease epidemics in 2008 or in the preceding years.

The above observation is not necessarily reflected in the use of all species in particular for the use of mice and other birds by some Member States.

Regarding the specific animal diseases studies linked to the increase in the number of birds, Member States reported studies on bird flu, Gumboro disease and bronchitis including studies on quality and safety of vaccines.

Table 4.1: Number of animals used in experiments for studies on human and animal diseases

Main category of diseases versus species
   
  
Data of 2008 \*

|  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
| 4.1 Species | 4.2 Human cardiovascular diseases | 4.3 Human nervous and mental disorders | 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5 Other human diseases | 4.6 Studies specific to animal diseases | 4.7 Total |
| 1.a.    Mice (Mus musculus) | 249486 | 858612 | 803038 | 1883499 | 292772 | 4087407 |
| 1.b.    Rats (Rattus norvegicus) | 125904 | 489630 | 43336 | 600979 | 16909 | 1276758 |
| 1.c.    Guinea-Pigs (Cavia porcellus) | 2856 | 5004 | 262 | 47326 | 3252 | 58700 |
| 1.d.    Hamsters (Mesocricetus ) | 1940 | 2986 | 791 | 6751 | 3104 | 15572 |
| 1.e.    Other Rodents (other Rodentia) | 673 | 6737 | 239 | 5093 | 4617 | 17359 |
| 1.f.    Rabbits (Oryctolagus cuniculus) | 5373 | 1386 | 1781 | 28138 | 6983 | 43661 |
| 1.g.    Cats (Felis catus) | 14 | 169 | 0 | 126 | 1930 | 2239 |
| 1.h.    Dogs (Canis familiaris) | 1233 | 207 | 144 | 4544 | 3810 | 9938 |
| 1.i.    Ferrets (Mustela putorius furo) | 20 | 184 | 0 | 2153 | 105 | 2462 |
| 1.j.    Other Carnivores (other Carnivore) | 72 | 0 | 0 | 468 | 411 | 951 |
| 1.k.    Horses, donkeys and cross breds (Equidae) | 3 | 0 | 0 | 154 | 1614 | 1771 |
| 1.l.    Pigs (Sus) | 4638 | 417 | 100 | 9589 | 17299 | 32043 |
| 1.m.    Goats (Capra) | 170 | 39 | 87 | 478 | 1014 | 1788 |
| 1.n.    Sheep (Ovis) | 597 | 601 | 24 | 8065 | 6833 | 16120 |
| 1.o.    Cattle (Bos) | 243 | 36 | 0 | 2860 | 13756 | 16895 |
| 1.p.    Prosimians (Prosimia) | 0 | 40 | 0 | 311 | 370 | 721 |
| 1.q.    New World Monkeys (Ceboidea) | 7 | 101 | 0 | 419 | 21 | 548 |
| 1.r.    Old World Monkeys (Cercopithecoidea) | 111 | 261 | 6 | 3173 | 8 | 3559 |
| 1.s.    Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t.    Other Mammals (other Mammalia) | 29 | 55 | 5 | 887 | 449 | 1425 |
| 1.u.    Quail (Coturnix coturnix) | 0 | 400 | 0 | 177 | 413 | 990 |
| 1.v.    Other birds (other Aves) | 4769 | 4563 | 47 | 21365 | 194727 | 225471 |
| 1.w.    Reptiles (Reptilia) | 0 | 90 | 0 | 0 | 934 | 1024 |
| 1.x.    Amphibians (Amphibia) | 362 | 603 | 2886 | 10852 | 2022 | 16725 |
| 1.y.    Fish (Pisces) | 5841 | 57964 | 2458 | 381109 | 40958 | 488330 |
| 1.z.    TOTAL | 404341 | 1430085 | 855204 | 3018516 | 614311 | 6322457 |

France reporting for 2007

Table 4.2: Number of animals used in studies of diseases by classes of animals

  

|  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
| Classes of animals | Human Cardiovascular diseases | Human nervous and mental disorder | Human cancer (excl. evaluation of carcino. hazards) | Other human diseases | Specific animal diseases | Total |
| Mice | 249486 | 858612 | 803038 | 1883499 | 292772 | 4087407 |
| Rats | 125904 | 489630 | 43336 | 600979 | 16909 | 1276758 |
| Guinea-Pigs | 2856 | 5004 | 262 | 47326 | 3252 | 58700 |
| Other rodents | 2613 | 9723 | 1030 | 11844 | 7721 | 32931 |
| Rabbits | 5373 | 1386 | 1781 | 28138 | 6983 | 43661 |
| Carnivores | 1339 | 560 | 144 | 7291 | 6256 | 15590 |
| Artio + Perrisodactyla | 5651 | 1093 | 211 | 21146 | 40516 | 68617 |
| Prosimians+Monkeys+Apes | 118 | 402 | 6 | 3903 | 399 | 4828 |
| Other Mammals | 29 | 55 | 5 | 887 | 449 | 1425 |
| Birds | 4769 | 4963 | 47 | 21542 | 195140 | 226461 |
| Cold-blooded animals | 6203 | 58657 | 5344 | 391961 | 43914 | 506079 |
| TOTAL | 404341 | 1430085 | 855204 | 3018516 | 614311 | 6322457 |
|  |  |  |  |  |  |  |
| Classes of animals% | Human Cardiovascular diseases | Human nervous and mental disorder | Human cancer (excl. evaluation of carcino. hazards) | Other human diseases | Specific animal diseases | Total |
| Mice | 6,10 | 21,01 | 19,65 | 46,08 | 7,16 | 100,00 |
| Rats | 9,86 | 38,35 | 3,39 | 47,07 | 1,32 | 100,00 |
| Guinea-Pigs | 4,87 | 8,52 | 0,45 | 80,62 | 5,54 | 100,00 |
| Other rodents | 7,93 | 29,53 | 3,13 | 35,97 | 23,45 | 100,00 |
| Rabbits | 12,31 | 3,17 | 4,08 | 64,45 | 15,99 | 100,00 |
| Carnivores | 8,59 | 3,59 | 0,92 | 46,77 | 40,13 | 100,00 |
| Artio + Perrisodactyla | 8,24 | 1,59 | 0,31 | 30,82 | 59,05 | 100,00 |
| Prosimians+Monkeys+Apes | 2,44 | 8,33 | 0,12 | 80,84 | 8,26 | 100,00 |
| Other Mammals | 2,04 | 3,86 | 0,35 | 62,25 | 31,51 | 100,00 |
| Birds | 2,11 | 2,19 | 0,02 | 9,51 | 86,17 | 100,00 |
| Cold-blooded animals | 1,23 | 11,59 | 1,06 | 77,45 | 8,68 | 100,00 |

Species of Table 4.1 were grouped into classes of animals and presented in Table 4.2. The relative percentage of animals per class of species used in studies by type of disease has been calculated and is also presented in the lower part of Table 4.2.

Figure 4.2 presents the proportion of animals used by classes per type of studies of diseases.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58008.jpg)

The top of each bar shows the relative percentage of animals used for studies on specific animal diseases. Significant numbers of both artiodactyla and perissodactyla and birds are used for this purpose. Member States reported that it is still current practice to test vaccines on these species. However, in some Member States only birds are used if the infection concerns bird species.

The data on the use of most species for all types of studies on both human and animal diseases show a great similarity to the data of 2005. However, there is a substantial decrease in the use of ‘other mammals’ for studies of human diseases in particular 'other human diseases', whereas the opposite is observed for cold-blooded animals which have been more widely used in studies on human diseases rather than animal diseases.

III.6.Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine

III.6.1.The data on animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine

The consolidated table for the 27 Member States reporting the origin of the regulatory requirements in relation to animals used for the production and quality control of products for human medicine and dentistry and for veterinary medicine (EU Table 5) is presented in Table 5.1 at the end of this chapter.

III.6.2.Treatment and interpretation of the data

The number of animals used in tests for the production and quality control of products for human medicine and dentistry and for veterinary medicine represents 14,9% of the total number of animals used for experimental purposes. Figure 5 gives the percentages of the animals used to satisfy the different regional regulatory requirements in this area.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58009.jpg)

The largest proportion of animals in this area (47%) was used to satisfy requirements from several pieces of legislation (from national, the EU, the Council of Europe member country legislation, and from legislation outside of the EU (Fig 5)). The testing carried out to satisfy EU legislation including the European Pharmacopoeia covered 41,1% of the animals used in this area.

In comparison to the report of 2005 there is a net decrease in the number of animals used to satisfy simultaneously several pieces of legislation. On the other hand there is a net increase of tests carried out for the European legislation (including the European Pharmacopoeia).

Consequently, there is a net decrease in the number of animals used to satisfy national legislation, which is an encouraging trend showing an attempt to move towards EU harmonisation of regulatory requirements.

Table 5.1: Number of animals used in the production and quality control of products and devices for human medicine and dentistry and for veterinary medicine

Regulatory requirements versus species

Data of 2008 \*

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1. Species | 5.2. National legislation specific to a single EC Member State1 | 5.3. EC legislation including European Pharmacopoeia (requirements) | 5.4. Member Country of Council of Europe (but not EC) legislation2) | 5.5. Other legislation | 5.6. Any combination of 5.2/ 5.3/ 5.4/ 5.5 | 5.7. No regulatory requirements | 5.8. Total |
| 1.a.    Mice (Mus musculus) | 33233 | 359722 | 371 | 21567 | 569279 | 43303 | 1027475 |
| 1.b.    Rats (Rattus norvegicus) | 5107 | 86403 | 405 | 16406 | 105741 | 5319 | 219381 |
| 1.c.    Guinea-Pigs (Cavia porcellus) | 2519 | 43916 | 0 | 6494 | 62550 | 5615 | 121094 |
| 1.d.    Hamsters (Mesocricetus ) | 0 | 8916 | 0 | 358 | 3613 | 2 | 12889 |
| 1.e.    Other Rodents (other Rodentia) | 0 | 0 | 0 | 0 | 30 | 0 | 30 |
| 1.f.    Rabbits (Oryctolagus cuniculus) | 851 | 107271 | 0 | 1077 | 53039 | 20539 | 182777 |
| 1.g.    Cats (Felis catus) | 43 | 614 | 0 | 8 | 58 | 10 | 733 |
| 1.h.    Dogs (Canis familiaris) | 208 | 985 | 0 | 0 | 982 | 55 | 2230 |
| 1.i.    Ferrets (Mustela putorius furo) | 0 | 2 | 0 | 0 | 522 | 48 | 572 |
| 1.j.    Other Carnivores (other Carnivore) | 27 | 311 | 0 | 0 | 0 | 0 | 338 |
| 1.k.    Horses, donkeys and cross breds (Equidae) | 307 | 225 | 0 | 0 | 164 | 2087 | 2783 |
| 1.l.    Pigs (Sus) | 518 | 5436 | 0 | 91 | 2385 | 994 | 9424 |
| 1.m.    Goats (Capra) | 68 | 27 | 0 | 3 | 10 | 11 | 119 |
| 1.n.    Sheep (Ovis) | 805 | 1523 | 54 | 5 | 703 | 5079 | 8169 |
| 1.o.    Cattle (Bos) | 139 | 2500 | 0 | 6 | 414 | 469 | 3528 |
| 1.p.    Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.q.    New World Monkeys (Ceboidea) | 0 | 0 | 0 | 0 | 33 | 0 | 33 |
| 1.r.    Old World Monkeys (Cercopithecoidea) | 0 | 0 | 0 | 0 | 231 | 0 | 231 |
| 1.s.    Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t.    Other Mammals (other Mammalia) | 13 | 50 | 0 | 0 | 0 | 28 | 91 |
| 1.u.    Quail (Coturnix coturnix) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.v.    Other birds (other Aves) | 1887 | 117540 | 60 | 1676 | 41194 | 7556 | 169913 |
| 1.w.    Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x.    Amphibians (Amphibia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.y.    Fish (Pisces) | 2260 | 1430 | 0 | 0 | 406 | 24137 | 28233 |
| 1.z.    TOTAL | 47985 | 736871 | 890 | 47691 | 841354 | 115252 | 1790043 |

(\*) France reporting for 2007

|  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- |
| Examples: | 5.2 - France is testing due to a UK (or FR) specific requirement | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out |
|  | 5.3 - UK is testing according to EC legislation | | |  | and not to the body which has issued the actual test method, guideline or protocol |
|  | 5.4 - Spain is testing due to a Norwegian requirement | | | Example: | a test required by French legislation and carried out in Belgium according to an |
|  | 5.5 – Poland is testing due to a US specific requirement | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be |
|  | 5.6 - Germany is testing due to a Swiss requirement (also an EC requirement) | | |  | entered into column 5.2 in the tables submitted by Belgium. |
|  |  | | |  |  |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of Macedonia' Turkey, Ukraine | | | |

III.7.Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations

III.7.1.The data on the origin of regulatory requirements for animals used in toxicological and other safety evaluations 

The consolidated table for the 27 Member States reporting data on animals used in toxicological and other safety evaluations in relation to the origin of regulatory requirements (EU Table 6) is presented in Table 6.1 at the end of this chapter.

III.7.2.Treatment and interpretation of the data

The use of animals for the regulatory requirements of different regions in the area of toxicological or other safety evaluation presented in Figure 6 follows a similar pattern to that of the use of animals used for regulatory purposes in human medicine, dentistry and in veterinary medicine in different regions, presented in the Figure 5 in the previous chapter.

As pointed out earlier, the number of animals used in toxicological or other safety evaluation represents 8,7% of the total number of animals used for experimental purposes in the EU.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58010.jpg)

Animals used to simultaneously satisfy regulatory requirements from several pieces of legislation covered almost half of the animals used in this area (50%). The testing required under EU legislation including the European Pharmacopoeia accounts for the second highest percentage in this area, namely 24%.

The increase of the numbers of animals used for toxicological and other safety evaluations since the last report is relatively low and represents about 15,800 animals.

In comparison to the last report there is a net slight decrease in the proportion of animals used to simultaneously satisfy several pieces of regional legislation from 54% to nearly 50%.

However, there is a substantial increase in the proportion of animals used for no regulatory requirements. In order to explain what is meant by the term 'no regulatory requirements', some Member States gave as an example projects using in-house methods to verify the safety and efficacy of veterinary biologicals and medicinal products using animals, and carried out according to a company’s standards. The results may be accepted by that Member State national authority, although not required by legislation.

The testing carried out in 2008 to satisfy national legislation specific to a single Member State showed a decrease of about 7,500 animals which represents roughly a 1,2% decrease compared to the last report.

   Table 6.1:
   Number of animals used in toxicological and other safety evaluations

Regulatory requirements versus species

Data of 2008\*

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1. Species | 6.2. National legislation specific to a single EC Member State1) | 6.3. EC legislation including European Pharmacopoeia (requirements) | 6.4. Member Country of Council of Europe (but not EC) legislation2) | 6.5. Other legislation | 6.6. Any combination of 5.2/ 5.3/ 5.4/ 5.5 | 6.7. No regulatory requirements | 6.8.Total |
| 1.a.    Mice (Mus musculus) | 35721 | 129353 | 752 | 5034 | 198942 | 28397 | 398199 |
| 1.b.    Rats (Rattus norvegicus) | 17191 | 51343 | 89 | 11496 | 194371 | 20093 | 294583 |
| 1.c.    Guinea-Pigs (Cavia porcellus) | 660 | 14723 | 84 | 390 | 15166 | 960 | 31983 |
| 1.d.    Hamsters (Mesocricetus ) | 101 | 238 | 0 | 0 | 1106 | 135 | 1580 |
| 1.e.    Other Rodents (other Rodentia) | 204 | 0 | 0 | 0 | 191 | 0 | 395 |
| 1.f.    Rabbits (Oryctolagus cuniculus) | 1179 | 12694 | 2 | 1744 | 23426 | 942 | 39987 |
| 1.g.    Cats (Felis catus) | 97 | 126 | 4 | 0 | 85 | 10 | 322 |
| 1.h.    Dogs (Canis familiaris) | 626 | 1421 | 58 | 769 | 8023 | 180 | 11077 |
| 1.i.    Ferrets (Mustela putorius furo) | 211 | 32 | 0 | 26 | 0 | 0 | 269 |
| 1.j.    Other Carnivores (other Carnivore) | 296 | 0 | 0 | 0 | 0 | 0 | 296 |
| 1.k.    Horses, donkeys and cross breds (Equidae) | 0 | 0 | 0 | 0 | 1 | 21 | 22 |
| 1.l.    Pigs (Sus) | 172 | 1177 | 8 | 181 | 6102 | 425 | 8065 |
| 1.m.    Goats (Capra) | 29 | 0 | 0 | 0 | 14 | 0 | 43 |
| 1.n.    Sheep (Ovis) | 2 | 75 | 0 | 0 | 322 | 10 | 409 |
| 1.o.    Cattle (Bos) | 10 | 226 | 0 | 44 | 173 | 0 | 453 |
| 1.p.    Prosimians (Prosimia) | 0 | 543 | 0 | 0 | 0 | 0 | 543 |
| 1.q.    New World Monkeys (Ceboidea) | 0 | 0 | 0 | 0 | 246 | 24 | 270 |
| 1.r.    Old World Monkeys (Cercopithecoidea) | 0 | 265 | 0 | 732 | 4599 | 98 | 5694 |
| 1.s.    Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t.    Other Mammals (other Mammalia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u.    Quail (Coturnix coturnix) | 24 | 680 | 0 | 0 | 1466 | 0 | 2170 |
| 1.v.    Other birds (other Aves) | 10 | 7406 | 0 | 5000 | 36017 | 2798 | 51231 |
| 1.w.    Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x.    Amphibians (Amphibia) | 0 | 0 | 0 | 0 | 179 | 112 | 291 |
| 1.y.    Fish (Pisces) | 32582 | 29413 | 0 | 1517 | 27071 | 103688 | 194271 |
| 1.z.    TOTAL | 89115 | 249715 | 997 | 26933 | 517500 | 157893 | 1042153 |

(\*)France is reporting for 2007

|  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- |
| Examples: | 6.2 - France is testing due to a UK (or FR) specific requirement | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and not to the body which has issued the actual test method, guideline or protocol |
|  | 6.3 - UK is testing according to EC legislation | | |  |  |
|  | 6.4 - Spain is testing due to a Norwegian requirement | | | Example: | a test required by French legislation and carried out in Belgium according to an |
|  | 6.5 – Poland is testing due to a US specific requirement | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be |
|  | 6.6 - Germany is testing due to a Swiss requirement (also an EC requirement) | | |  | entered into column 6.2 in the tables submitted by Belgium. |
|  |  | | |  |  |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of Macedonia' Turkey, Ukraine | | | |

III.8.Results of EU Table 7: Animals used in toxicity tests for toxicological and other safety evaluations

III.8.1.The data on animals used in toxicity test for toxicological and other safety evaluations

The consolidated table for the 27 Member States reporting on animals used in toxicity tests for the purpose of toxicological and other safety evaluations of products (EU Table 7) is presented in Table 7.1 at the end of this chapter.

III.8.2.Treatment and interpretation of the data

For the convenience of the presentation of results some of the toxicity tests of Table 7.1 have been grouped according to systemic and local toxicity and CMR (carcinogenicity, mutagenicity and toxicity to reproduction) effects in Table 7.2. A graph showing the percentage of animals used per toxicity test groups in 2008 is presented in Figure 7.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58011.jpg)

As pointed out in the previous chapter, the number of animals used in toxicological and other safety evaluations represents 8,7% of the total number of animals used for experimental purposes.

In Figure 7 the largest percentage (almost 45%) of use of animals in toxicological and other safety evaluations is due to acute and sub-acute toxicity tests. Also taking into account sub-chronic and chronic toxicity, the percentage of animals used in short and long term systemic toxicity testing accounts for 55% in this area.

13,7% of animals were used for testing carcinogenicity, mutagenicity and toxicity to reproduction. Another important category of use of animals in 2008 is for 'other tests' with 24%. Breaking down further the category 'other', Member States reported testing in areas such as biological screening for pharmaceutical, healthcare and veterinary products. This includes neurotoxicity, toxicokinetics, testing of biological evaluation of medical devices: Intracutaneous testing of reactivity in rabbits, studies into the penetration of nanoparticles through tissue and their biocompatibility, studies into the evaluation of sensitization potential of dyestuffs used in the textile industry and pharmacological studies included in safety tests.

By looking both in numbers and relative percentages of use of animals in comparison to the previous reports there are two noticeable changes:

There is a continuous increase over the last three reports of the proportion of animals used for acute and sub-acute tests, ranging from 36% - 42% to almost 45% respectively. This represents in animal numbers an increase of more than 37,000 animals since the last report. Member States attributed the increase in part to several phases in new product development and new legislation, for example requiring that all generic substances should be tested.

On the other hand one can observe a steady decrease over the last three reports of the animals used for reproductive toxicity testing from: 12% to 10% and to 9% respectively. This demonstrates a saving since the 2005 report of 8,650 animals.

A general decrease in the number of animals used for regulatory toxicological evaluation could be attributed to the use of alternative methods according to some Member States. However, others have suggested that replacement methods have a much greater impact on research and development than on regulatory requirements.

Table 7.1: Number of animals used in toxicological and other safety evaluations

Type of tests versus species

Data of 2008\*

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1. Species | 7.2. Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3. Skin irritation | 7.4. Skin sensitisation | 7.5. Eye irritation | 7.6. Sub- chronic and chronic toxicity | 7.7. Carcino- genicity | 7.8. Develop- mental toxicity | 7.9. Muta- genicity | 7.10. Repro-ductive toxicity | 7.11. Toxicity to aquatic vertebra-tes not included in other columns | 7.12. Other | 7.13. Total |
|  | 7.2.1. LD50, LC50 | 7.2.2. Other lethal methods | 7.2.3. Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 1.a.    Mice (Mus musculus) | 87440 | 87455 | 46654 | 926 | 16742 | 30 | 27173 | 10375 | 3744 | 12858 | 2759 | 200 | 101843 | 398199 |
| 1.b.    Rats (Rattus norvegicus) | 7060 | 12651 | 74924 | 768 | 1465 | 78 | 54915 | 10219 | 20263 | 14043 | 51314 | 26 | 46957 | 294683 |
| 1.c.    Guinea-Pigs (Cavia porcellus) | 1000 | 303 | 3363 | 140 | 20198 | 6 | 618 | 0 | 120 | 0 | 101 | 7 | 6027 | 31883 |
| 1.d.    Hamsters (Mesocricetus ) | 16 | 0 | 343 | 22 | 0 | 0 | 310 | 0 | 0 | 21 | 0 | 0 | 868 | 1580 |
| 1.e.    Other Rodents (other Rodentia) | 27 | 0 | 0 | 0 | 0 | 0 | 204 | 0 | 0 | 0 | 0 | 0 | 164 | 395 |
| 1.f.    Rabbits (Oryctolagus cuniculus) | 110 | 38 | 5875 | 4200 | 32 | 2105 | 1240 | 0 | 6047 | 0 | 5349 | 7 | 14984 | 39987 |
| 1.g.    Cats (Felis catus) | 0 | 0 | 24 | 0 | 0 | 0 | 62 | 0 | 0 | 0 | 0 | 0 | 236 | 322 |
| 1.h.    Dogs (Canis familiaris) | 15 | 339 | 4637 | 0 | 0 | 0 | 4582 | 0 | 0 | 0 | 20 | 0 | 1484 | 11077 |
| 1.i.    Ferrets (Mustela putorius furo) | 0 | 0 | 211 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 58 | 269 |
| 1.j.    Other Carnivores (other Carnivore) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 296 | 296 |
| 1.k.    Horses, donkeys and cross breds (Equidae) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 22 | 22 |
| 1.l.    Pigs (Sus) | 0 | 11 | 535 | 115 | 0 | 0 | 937 | 0 | 0 | 0 | 112 | 0 | 6355 | 8065 |
| 1.m.    Goats (Capra) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 43 | 43 |
| 1.n.    Sheep (Ovis) | 0 | 0 | 36 | 0 | 0 | 0 | 34 | 0 | 0 | 0 | 0 | 0 | 339 | 409 |
| 1.o.    Cattle (Bos) | 0 | 0 | 60 | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 22 | 0 | 359 | 453 |
| 1.p.    Prosimians (Prosimia) | 0 | 0 | 261 | 0 | 0 | 0 | 143 | 0 | 0 | 0 | 0 | 0 | 139 | 543 |
| 1.q.    New World Monkeys (Ceboidea) | 0 | 0 | 65 | 0 | 0 | 0 | 71 | 0 | 64 | 0 | 0 | 0 | 70 | 270 |
| 1.r.    Old World Monkeys (Cercopithecoidea) | 18 | 0 | 1735 | 0 | 0 | 0 | 2861 | 0 | 176 | 0 | 58 | 0 | 846 | 5694 |
| 1.s.    Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t.    Other Mammals (other Mammalia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u.    Quail (Coturnix coturnix) | 819 | 241 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 176 | 0 | 934 | 2170 |
| 1.v.    Other birds (other Aves) | 456 | 135 | 5937 | 1020 | 0 | 65 | 0 | 0 | 0 | 0 | 108 | 0 | 43510 | 51231 |
| 1.w.    Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x.    Amphibians (Amphibia) | 0 | 0 | 0 | 0 | 0 | 0 | 108 | 0 | 4 | 0 | 0 | 0 | 179 | 291 |
| 1.y.    Fish (Pisces) | 50983 | 70000 | 5110 | 119 | 0 | 0 | 9735 | 213 | 868 | 0 | 3796 | 24857 | 28590 | 194271 |
| 1.z.    TOTAL | 147944 | 171173 | 149770 | 7310 | 38437 | 2284 | 103005 | 20807 | 31286 | 26922 | 63815 | 25097 | 254303 | 1042153 |

(\*) France reporting for 2007

Table 7.2: Grouping of certain type of tests on animals of table 7.1
   

|  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1. Species | Acute and sub-acute toxicity testing methods (including limit test) | Irritation /sensitization tests | Sub- chronic and chronic toxicity | Mutagenicity and carcinogenicity | Reproductive and developmental toxicity | Toxicity to aquatic vertebrates not included in other columns | other | Total |
| 1.a.    Mice (Mus musculus) | 221549 | 17698 | 27173 | 23233 | 6503 | 200 | 101843 | 398199 |
| 1.b.    Rats (Rattus norvegicus) | 94635 | 2311 | 54915 | 24262 | 71577 | 26 | 46957 | 294683 |
| 1.c.    Guinea-Pigs (Cavia porcellus) | 4666 | 20344 | 618 | 0 | 221 | 7 | 6027 | 31883 |
| 1.d.    Hamsters (Mesocricetus ) | 359 | 22 | 310 | 21 | 0 | 0 | 868 | 1580 |
| 1.e.    Other Rodents (other Rodentia) | 27 | 0 | 204 | 0 | 0 | 0 | 164 | 395 |
| 1.f.    Rabbits (Oryctolagus cuniculus) | 6023 | 6337 | 1240 | 0 | 11396 | 7 | 14984 | 39987 |
| 1.g.    Cats (Felis catus) | 24 | 0 | 62 | 0 | 0 | 0 | 236 | 322 |
| 1.h.    Dogs (Canis familiaris) | 4991 | 0 | 4582 | 0 | 20 | 0 | 1484 | 11077 |
| 1.i.    Ferrets (Mustela putorius furo) | 211 | 0 | 0 | 0 | 0 | 0 | 58 | 269 |
| 1.j.    Other Carnivores (other Carnivore) | 0 | 0 | 0 | 0 | 0 | 0 | 296 | 296 |
| 1.k.    Horses, donkeys and cross breds (Equidae) | 0 | 0 | 0 | 0 | 0 | 0 | 22 | 22 |
| 1.l.    Pigs (Sus) | 546 | 115 | 937 | 0 | 112 | 0 | 6355 | 8065 |
| 1.m.    Goats (Capra) | 0 | 0 | 0 | 0 | 0 | 0 | 43 | 43 |
| 1.n.    Sheep (Ovis) | 36 | 0 | 34 | 0 | 0 | 0 | 339 | 409 |
| 1.o.    Cattle (Bos) | 60 | 0 | 12 | 0 | 22 | 0 | 359 | 453 |
| 1.p.    Prosimians (Prosimia) | 261 | 0 | 143 | 0 | 0 | 0 | 139 | 543 |
| 1.q.    New World Monkeys (Ceboidea) | 65 | 0 | 71 | 0 | 64 | 0 | 70 | 270 |
| 1.r.    Old World Monkeys (Cercopithecoidea) | 1753 | 0 | 2861 | 0 | 234 | 0 | 846 | 5694 |
| 1.s.    Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t.    Other Mammals (other Mammalia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u.    Quail (Coturnix coturnix) | 1060 | 0 | 0 | 0 | 176 | 0 | 934 | 2170 |
| 1.v.    Other birds (other Aves) | 6528 | 1085 | 0 | 0 | 108 | 0 | 43510 | 51231 |
| 1.w.    Reptiles (Reptilia) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.x.    Amphibians (Amphibia) | 0 | 0 | 108 | 0 | 4 | 0 | 179 | 291 |
| 1.y.    Fish (Pisces) | 126093 | 119 | 9735 | 213 | 4664 | 24857 | 28590 | 194271 |
| 1.z.    TOTAL | 468887 | 48031 | 103005 | 47729 | 95101 | 25097 | 254303 | 1042153 |

III.9.Results of EU Table 8: Type of toxicity tests carried out for toxicological and other safety evaluations of products

III.9.1.The data on type of toxicity tests carried out for toxicological and other safety evaluations of products

The consolidated table for the type of toxicity tests carried out for toxicological or other safety evaluations of products for the 27 Member States reporting (EU table 8) is presented in table 8.1 of this report. The data in table 8 have been subjected to a further quality criteria check developed by the Commission. The data provided by all Member States for this report were coherent.

III.9.2.Treatment and interpretation of the data

As pointed out earlier, animals used in toxicological and other safety evaluation represent 8,7% of the total number of animals used for experimental purposes.

In order to facilitate the interpretation of the results some types of toxicity testing have been grouped and the results can be found in consolidated table 8.2 at the end of this chapter. Figure 8 gives the proportion of animals used for toxicity and other safety evaluation by types of products.

The treatment and interpretation of the data on animals used for toxicity tests with regard to the type of products was done for the first time in the Fifth Statistical Report. However, because the graph in that report represented more the relative importance of tests within a type of product rather than the proportion of animals used per type of test for the different products, the graph was modified accordingly for this report.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_51.xhtml.58012.jpg)

Figure 8 shows that the majority of animals tested in acute/sub-acute toxicity are intended for the purpose of human medicine, dentistry and veterinary medicine. This is followed by tests carried out for other toxicological or safety evaluation and then for agriculture and industrial products.

Products intended for medicine, dentistry and veterinary medicine require the highest proportion of animals for the different types of tests i.e. approximately 50%. The next highest proportion is for ‘other’ toxicological evaluations, above 20%, followed by animals used in tests for products for agriculture and industry each above 7%.

Table 8.1:
   Number of animals used in toxicological and other safety evaluations

Type of tests versus products

Data of 2008\*

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1. Products | 8.2. Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3. Skin irritation | 8.4. Skin sensitisation | 8.5. Eye irritation | 8.6. Sub- chronic and chronic toxicity | 8.7. Carcino- genicity | 8.8. Develop- mental toxicity | 8.9. Muta- genicity | 8.10. Repro-ductive toxicity | 8.11. Toxicity to aquatic vertebra-tes not included in other columns | 8.12. Other | 8.13. Total |
|  | 8.2.1. LD50, LC50 | 8.2.2. Other lethal methods | 8.2.3. Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine | 43643 | 85795 | 116481 | 3732 | 17719 | 506 | 62442 | 15063 | 12314 | 14286 | 37079 | 3917 | 116640 | 529617 |
| 8.b. Products/ substances used or intended to be used mainly in agriculture | 9066 | 4192 | 4987 | 724 | 4252 | 581 | 10089 | 3590 | 3120 | 2224 | 11578 | 11884 | 7860 | 74147 |
| 8.c. Products/ substances used or intended to be used mainly in industry | 5263 | 4832 | 12483 | 2368 | 11129 | 1001 | 8324 | 306 | 11475 | 6490 | 8863 | 2870 | 7022 | 82426 |
| 8.d. Products/ substances used or intended to be used mainly in the household | 617 | 1636 | 50 | 143 | 0 | 27 | 159 | 0 | 0 | 114 | 1016 | 0 | 520 | 4282 |
| 8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries | 822 | 207 | 98 | 87 | 699 | 54 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1967 |
| 8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption | 64 | 112 | 213 | 3 | 0 | 6 | 1421 | 649 | 3157 | 320 | 167 | 0 | 128 | 6240 |
| 8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption | 0 | 9142 | 177 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 0 | 80 | 44665 | 54164 |
| 8.h. Potential or actual contaminants in the general environment which do not appear in other columns | 37714 | 6243 | 2206 | 119 | 0 | 0 | 6294 | 213 | 85 | 1502 | 4111 | 4713 | 3410 | 66610 |
| 8.i. Other toxicological or safety evaluations | 10080 | 60404 | 7909 | 173 | 1797 | 94 | 8004 | 2625 | 319 | 2937 | 3176 | 1234 | 123948 | 222700 |
| 8.j. TOTAL | 107269 | 172563 | 144604 | 7349 | 35596 | 2269 | 96833 | 22446 | 30470 | 27873 | 65990 | 24698 | 304193 | 1042153 |

(\*) France reporting for 2007

Table 8.2: Number of animals used in toxicological and other safety evaluation per types of products

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1. Products | Acute and sub-acute toxicity testing methods (including limit test) | Irritation/sensitization tests | Sub- chronic and chronic toxicity | carcinogenicity, Mutagenicity and Reprotox. | Toxicity to aquatic vertebrates not included in other columns | Other | Total |
| 8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine | 245919 | 21957 | 62442 | 78742 | 3917 | 116640 | 529617 |
| 8.b. Products/ substances used or intended to be used mainly in agriculture | 18245 | 5557 | 10089 | 20512 | 11884 | 7860 | 74147 |
| 8.c. Products/ substances used or intended to be used mainly in industry | 22578 | 14498 | 8324 | 27134 | 2870 | 7022 | 82426 |
| 8.d. Products/ substances used or intended to be used mainly in the household | 2303 | 170 | 159 | 1130 | 0 | 520 | 4282 |
| 8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries | 1127 | 840 | 0 | 0 | 0 | 0 | 1967 |
| 8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption | 389 | 9 | 1421 | 4293 | 0 | 128 | 6240 |
| 8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption | 9319 | 0 | 100 | 0 | 80 | 44665 | 54164 |
| 8.h. Potential or actual contaminants in the general environment which do not appear in other columns | 46163 | 119 | 6294 | 5911 | 4713 | 3410 | 66610 |
| 8.i. Other toxicological or safety evaluations | 78393 | 2064 | 8004 | 9057 | 1234 | 123948 | 222700 |
| 8.j. TOTAL | 424436 | 45214 | 96833 | 146779 | 24698 | 304193 | 1042153 |

:   [(1)](#footnoteref1)
    OJ L 358, 18.12.1986, p.1.
:   [(2)](#footnoteref2)
    COM (94) 195 final
:   [(3)](#footnoteref3)
    COM (1999) 191 final
:   [(4)](#footnoteref4)
    COM (2003) 19 final
:   [(5)](#footnoteref5)
    COM (2005) 7 final
:   [(6)](#footnoteref6)
    COM (2007) 675 final
:   [(7)](#footnoteref7)
    OJ C 331, 23.12.86, p. 2.

[Top](#document2)

EN

|  |  |
| --- | --- |
|  | EUROPEAN COMMISSION |

Brussels, 30.9.2010

SEC(2010) 1107 final

VOL B - Part I ([II], [III])

COMMISSION STAFF WORKING DOCUMENT

DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
  

  
Accompanying document to the
  
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
  

  
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

COM(2010) 511 final

Important notice

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

VOL B - Part I: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

TABLE OF CONTENTS

BELGIUM
   5

BULGARIA
   20

CZECH REPUBLIC
   30

DENMARK
   39

GERMANY
   48

ESTONIA
   58

IRELAND
   67

GREECE
   76

SPAIN
   86

BELGIUM

Statistical data submitted

The statistical data have been submitted by the “SPF Santé Publique, Sécurité de la Chaine Alimentaire et Environnement” (Federal Public Service of Public Health, Food Chain Safety and Environment).

Comments of the Belgian authorities

1.Laboratories

Every year, all laboratories in Belgium that use animals for experimental purposes must provide statistical information on the number of animals used the previous year.

In 2008, 389 laboratories were approved as regards the use of animals for experimental purposes and they all provided their statistical data. A quarter of these laboratories had not used any animals for experimental purposes in 2008.

2.Number of animals used in experiments

In all 725370 animals were used. Rodents and rabbits accounted for 93%, fish, reptiles and amphibians for 4% and birds for 2% of the total number of animals used.

Dogs, cats and primates accounted respectively for 0,10%, 0,01% and 0,005% of the animals used in 2008 (Figure 1: Breakdown of species used in experiments)

![](./../../../resource.html?uri=comnat:sec2010_1107en01_52.xhtml.59002.jpg)

   Figure 1:
   Breakdown of species used in experiments

A comparison of the absolute figures for 2008 with those for 2007 (Table 1: Trend in the number of animals used in experiments) shows an overall decrease of 54,490 animals (-7%).

This decrease concerns mainly rodents (-53,454; -8%) and fish (-12,489; -31%). However, for some species there has been a marked increase. These are rabbits (+7,301; +21%), mainly used in certain therapeutic polyclonal antibody development programmes, and birds (+4,622; +36%) which were used in 2008 for food tests on poultry. The number of monkeys remained stable and limited in 2008 (41 animals) and in 2007 (38 animals). These primates are used for vaccine quality control tests and for studies of human diseases (neurophysiology).

  

Table 1:
   Table 1: Trend in the number of animals used in experiments

|  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- |
|  | 2008 | 2007 | 2006 | 2005 | 2004 |
| Mice | 480.681 | 518.208 | 516.148 | 488.125 | 482.810 |
| Rats | 108.580 | 116.991 | 104.272 | 106.483 | 119.193 |
| Guinea pigs | 36.554 | 43.499 | 38.542 | 39.530 | 38.781 |
| Hamsters | 2.124 | 1.882 | 1.614 | 1.874 | 1.688 |
| Other rodents | 1.055 | 1.908 | 1.627 | 2.260 | 3.921 |
| Rabbits | 42.025 | 34.724 | 30.518 | 21.159 | 18.577 |
| Total rodents and rabbits | 671.019 | 717.212 | 692.721 | 659.431 | 664.970 |
| Cats | 78 | 46 | 107 | 81 | 184 |
| Dogs | 788 | 747 | 1.207 | 1.295 | 1.014 |
| Ferrets | 324 | 336 | 234 | 154 | 102 |
| Other carnivores | 0 | 0 | 0 | 0 | 0 |
| Total carnivores | 1.190 | 1.129 | 1.548 | 1.530 | 1.300 |
| Horses, donkeys and cross-breeds | 62 | 103 | 108 | 108 | 65 |
| Pigs | 2.969 | 2.657 | 2.022 | 1.876 | 2.272 |
| Goats | 195 | 122 | 116 | 157 | 125 |
| Sheep | 356 | 291 | 295 | 445 | 495 |
| Cattle | 657 | 616 | 758 | 944 | 982 |
| Total ungulates | 4.239 | 3.789 | 3.299 | 3.530 | 3.939 |
| Prosimians | 0 | 0 | 0 | 0 | 0 |
| New world monkeys | 0 | 0 | 0 | 0 | 7 |
| Old world monkeys | 41 | 38 | 196 | 449 | 579 |
| Apes | 0 | 0 | 0 | 0 | 0 |
| Total primates | 41 | 38 | 196 | 449 | 586 |
| Other mammals | 151 | 124 | 88 | 59 | 44 |
| Total mammals | 676.640 | 722.292 | 697.852 | 664.999 | 670.839 |
| Quails | 431 | 18 | 35 | 425 | 350 |
| Other birds | 17.151 | 12.942 | 16.127 | 13.266 | 10.492 |
| Total birds | 17.582 | 12.960 | 16.162 | 13.691 | 10.842 |
| Reptiles | 374 | 256 | 121 | 1.44 | 129 |
| Amphibians | 2.388 | 3477 | 3.516 | 6.177 | 6.362 |
| Fish | 28.386 | 40.875 | 39.064 | 33.965 | 20.574 |
| Total cold-blooded animals | 31.148 | 44.608 | 42.701 | 40.286 | 27.065 |
| TOTAL ANIMALS | 725.370 | 779.860 | 756.715 | 718.976 | 708.746 |

The headings in the statistical tables have remained unchanged since 1999. Taking 1999 as a reference year, figure 2 (figure 2: Trend in the number of animals used since 1999) shows that the number of animals used in Belgian laboratories has been relatively stable since then. In 2008 the figure was 8% lower than in 1999.

However, the number of animals has been increasing slightly each year since 2000. This trend must be seen in the context of the high level of research in Belgium, as the increase is essentially due to the rise in the number of animals used in basic research (+34,8% between 2000 and 2008).

![](./../../../resource.html?uri=comnat:sec2010_1107en01_52.xhtml.59003.jpg)

Figure 2:
   Trend in the number of animals used since 1999

3.Experiments carried out

In descending order, animals were used mainly to research and develop products and devices used in human and veterinary medicine (32% of the animals used), in basic research studies (30%) and in tests on the production and quality control of such products and devices (30%) (Figure 3: Breakdown of the experimental fields).

As regards production and quality control tests, 99% of the animals were used to comply with statutory requirements.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_52.xhtml.59004.jpg)

   Figure 3: Breakdown of the experimental fields

The following diagram (Figure 4: Breakdown of experimental fields by the animals most used) shows that of all the species, rodents are the most used. Rodents account for 82% of animals used for basic research, 94% of animals used for research and development tests on products and devices used in human and veterinary medicine and 84% of animals used for tests on the production and quality control of medical products and devices. Fish account for 11% of the animals used in basic research.

Toxicology and safety tests account for 3% of the animals used in experiments in 2008; 85% of the animals used in toxicology tests were used in safety trials required by law (Figure 5: Proportion of quality control and toxicology tests imposed by law).

Rodents account for 91% of all the animals used in toxicology tests. The other species used are mainly rabbits (5%) and dogs (2,8%).

![](./../../../resource.html?uri=comnat:sec2010_1107en01_52.xhtml.59005.jpg)

Figure 4: Breakdown of experimental fields by the animals most used

![](./../../../resource.html?uri=comnat:sec2010_1107en01_52.xhtml.59006.jpg)

Figure 5: Proportion of quality control and toxicology tests imposed by law

  

Provenance of animals used in experiments

In 2008, 89,7% of the animals used for experimental purposes came from approved suppliers in Belgium, other countries of the European Union or members of the Council of Europe and 2,9% came from establishments outside these territories. The other species of animal that are not reared solely for the purposes of agricultural experiments come from establishments that meet the current legal requirements for commercial establishments. The number of animals reused in certain experiments was 0,16% of the total number of animals used in 2008.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 480681 | 141865 | 317570 | 2367 | 18879 |  |
| 1.b. | Rats (Rattus norvegicus) | 108580 | 19139 | 88029 | 116 | 1296 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 36554 | 4648 | 29865 | 2041 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 2124 | 724 | 289 | 1074 | 37 |  |
| 1.e. | Other Rodents (other Rodentia) | 1055 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 42025 | 38836 | 3189 | 0 | 0 | 589 |
| 1.g. | Cats (Felis catus) | 78 | 31 | 47 | 0 | 0 | 48 |
| 1.h. | Dogs (Canis familiaris) | 788 | 47 | 289 | 0 | 452 | 483 |
| 1.i. | Ferrets (Mustela putorius furo) | 324 | 0 | 185 | 0 | 139 | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 0 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 62 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 2969 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 195 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 356 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 657 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.q. | New World Monkeys (Ceboidea) | 0 | 0 | 0 | 0 | 0 | 5 |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 41 | 0 | 12 | 0 | 29 | 28 |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. | Other Mammals (other Mammalia) | 151 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 431 | 431 | 0 | 0 | 0 |  |
| 1.v. | Other birds (other Aves) | 17151 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 374 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 2388 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 28386 |  |  |  |  |  |
| 1.z. | TOTAL | 725370 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 155149 | 155327 | 138227 | 2445 | 8950 | 8282 | 10086 | 2215 | 480681 |
| 2.b. | Rats | 20692 | 59947 | 11668 | 697 | 12705 | 246 | 2266 | 359 | 108580 |
| 2.c. | Guinea-Pigs | 388 | 3531 | 29243 | 647 | 153 | 0 | 2583 | 9 | 36554 |
| 2.d. | Hamsters | 377 | 0 | 2 | 1653 | 30 | 0 | 62 | 0 | 2124 |
| 2.e. | Other Rodents | 391 | 660 | 0 | 0 | 0 | 0 | 4 | 0 | 1055 |
| 2.f. | Rabbits | 1441 | 5293 | 3389 | 30388 | 1213 | 4 | 251 | 46 | 42025 |
| 2.g. | Cats | 27 | 33 | 0 | 18 | 0 | 0 | 0 | 0 | 78 |
| 2.h. | Dogs | 49 | 38 | 0 | 18 | 682 | 1 | 0 | 0 | 788 |
| 2.i. | Ferrets | 12 | 312 | 0 | 0 | 0 | 0 | 0 | 0 | 324 |
| 2.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.k. | Horses, donkeys and cross breds | 25 | 2 | 0 | 0 | 0 | 0 | 35 | 0 | 62 |
| 2.l. | Pigs | 1309 | 486 | 0 | 1097 | 0 | 2 | 11 | 64 | 2969 |
| 2.m. | Goats | 53 | 142 | 0 | 0 | 0 | 0 | 0 | 0 | 195 |
| 2.n. | Sheep | 183 | 161 | 0 | 4 | 0 | 0 | 8 | 0 | 356 |
| 2.o. | Cattle | 130 | 85 | 0 | 374 | 44 | 0 | 19 | 5 | 657 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.r. | Old World Monkeys | 11 | 0 | 29 | 0 | 0 | 1 | 0 | 0 | 41 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 95 | 32 | 24 | 0 | 0 | 0 | 0 | 0 | 151 |
| 2.u. | Quail | 431 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 431 |
| 2.v. | Other birds | 10729 | 5855 | 0 | 87 | 0 | 0 | 0 | 480 | 17151 |
| 2.w. | Reptiles | 374 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 374 |
| 2.x. | Amphibians | 553 | 1500 | 0 | 0 | 108 | 0 | 227 | 0 | 2388 |
| 2.y. | Fish | 23406 | 265 | 0 | 0 | 66 | 0 | 3116 | 1533 | 28386 |
| 2.z. | TOTAL | 215825 | 233669 | 182582 | 37428 | 23951 | 8536 | 18668 | 4711 | 725370 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 6754 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2196 | 8950 |
| 3.b. | Rats | 11310 | 0 | 45 | 0 | 0 | 0 | 0 | 0 | 1350 | 12705 |
| 3.c. | Guinea-Pigs | 153 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 153 |
| 3.d. | Hamsters | 30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 30 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 1213 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1213 |
| 3.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.h. | Dogs | 682 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 682 |
| 3.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.l. | Pigs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 44 | 44 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.x. | Amphibians | 0 | 108 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 108 |
| 3.y. | Fish | 0 | 0 | 66 | 0 | 0 | 0 | 0 | 0 | 0 | 66 |
| 3.z. | TOTAL | 20142 | 108 | 111 | 0 | 0 | 0 | 0 | 0 | 3590 | 23951 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 6291 | 65749 | 42230 | 136336 | 3178 | 253784 |
| 4.b. | Rats | 1652 | 37145 | 1426 | 33261 | 106 | 73590 |
| 4.c. | Guinea-Pigs | 428 | 95 | 0 | 1805 | 67 | 2395 |
| 4.d. | Hamsters | 15 | 0 | 18 | 322 | 0 | 355 |
| 4.e. | Other Rodents | 0 | 640 | 0 | 320 | 76 | 1036 |
| 4.f. | Rabbits | 152 | 9 | 3 | 322 | 181 | 667 |
| 4.g. | Cats | 0 | 0 | 0 | 31 | 3 | 34 |
| 4.h. | Dogs | 202 | 0 | 0 | 56 | 0 | 258 |
| 4.i. | Ferrets | 0 | 0 | 0 | 312 | 12 | 324 |
| 4.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 36 | 36 |
| 4.l. | Pigs | 271 | 8 | 0 | 245 | 440 | 964 |
| 4.m. | Goats | 42 | 0 | 0 | 101 | 28 | 171 |
| 4.n. | Sheep | 145 | 0 | 0 | 0 | 3 | 148 |
| 4.o. | Cattle | 0 | 0 | 0 | 0 | 66 | 66 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.r. | Old World Monkeys | 0 | 0 | 0 | 12 | 0 | 12 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 3 | 6 | 5 | 4 | 61 | 79 |
| 4.u. | Quail | 0 | 400 | 0 | 0 | 0 | 400 |
| 4.v. | Other birds | 0 | 0 | 0 | 0 | 7881 | 7881 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 43 | 43 |
| 4.x. | Amphibians | 20 | 0 | 0 | 0 | 0 | 20 |
| 4.y. | Fish | 0 | 0 | 0 | 0 | 2111 | 2111 |
| 4.z. | TOTAL | 9221 | 104052 | 43682 | 173127 | 14292 | 344374 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | | 0 | 13396 | 0 | | 17081 | 109778 | 417 | 140672 |
| 5.b. | Rats | | | 0 | 752 | 0 | | 2135 | 7635 | 1843 | 12365 |
| 5.c. | Guinea-Pigs | | | 0 | 1609 | 0 | | 4708 | 23573 | 0 | 29890 |
| 5.d. | Hamsters | | | 0 | 579 | 0 | | 0 | 1074 | 2 | 1655 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 0 | 1960 | 0 | | 1049 | 30766 | 2 | 33777 |
| 5.g. | Cats | | | 0 | 18 | 0 | | 0 | 0 | 0 | 18 |
| 5.h. | Dogs | | | 0 | 18 | 0 | | 0 | 0 | 0 | 18 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.l. | Pigs | | | 0 | 1097 | 0 | | 0 | 0 | 0 | 1097 |
| 5.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.n. | Sheep | | | 0 | 4 | 0 | | 0 | 0 | 0 | 4 |
| 5.o. | Cattle | | | 13 | 361 | 0 | | 0 | 0 | 0 | 374 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 29 | 0 | 29 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 24 | 24 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 0 | 87 | 0 | | 0 | 0 | 0 | 87 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 13 | 19881 | 0 | | 24973 | 172855 | 2288 | 220010 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 626 | 1113 | 0 | | 0 | 5268 | 1943 | 8950 |
| 6.b. | Rats | | | 61 | 76 | 0 | | 1350 | 9775 | 1443 | 12705 |
| 6.c. | Guinea-Pigs | | | 0 | 104 | 0 | | 0 | 49 | 0 | 153 |
| 6.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 30 | 0 | 30 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 0 | 183 | 0 | | 0 | 1030 | 0 | 1213 |
| 6.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.h. | Dogs | | | 0 | 0 | 0 | | 0 | 682 | 0 | 682 |
| 6.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.l. | Pigs | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.o. | Cattle | | | 0 | 0 | 0 | | 44 | 0 | 0 | 44 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 108 | 108 |
| 6.y. | Fish | | | 0 | 0 | 0 | | 66 | 0 | 0 | 66 |
| 6.z. | TOTAL | | | 687 | 1476 | 0 | | 1460 | 16834 | 3494 | 23951 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 471 | 9 | 2068 | 0 | 0 | 0 | 553 | 821 | 0 | 202 | 1611 | 0 | 3215 | 8950 |
| 7.b. | Rats | 0 | 301 | 4533 | 0 | 0 | 0 | 1611 | 1428 | 0 | 1236 | 2151 | 0 | 1445 | 12705 |
| 7.c. | Guinea-Pigs | 0 | 0 | 27 | 0 | 104 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 22 | 153 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 30 | 30 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 0 | 0 | 306 | 156 | 9 | 0 | 0 | 0 | 0 | 0 | 610 | 0 | 132 | 1213 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.h. | Dogs | 0 | 0 | 409 | 0 | 0 | 0 | 82 | 0 | 0 | 0 | 0 | 0 | 191 | 682 |
| 7.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.l. | Pigs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 22 | 0 | 10 | 44 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 108 | 0 | 0 | 0 | 0 | 0 | 0 | 108 |
| 7.y. | Fish | 66 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 66 |
| 7.z. | TOTAL | 537 | 310 | 7343 | 156 | 113 | 0 | 2366 | 2249 | 0 | 1438 | 4394 | 0 | 5045 | 23951 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 471 | 283 | 7020 | 156 | 113 | 0 | 1786 | 2228 | 0 | 853 | 4372 | 0 | 2860 | 20142 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 0 | 0 | 0 | 0 | 0 | 0 | 108 | 0 | 0 | 0 | 0 | 0 | 0 | 108 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 66 | 27 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 111 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.i. | Other toxicological or safety evaluations | 0 | 0 | 305 | 0 | 0 | 0 | 472 | 21 | 0 | 585 | 22 | 0 | 2185 | 3590 |
| 8.j. | TOTAL | 537 | 310 | 7343 | 156 | 113 | 0 | 2366 | 2249 | 0 | 1438 | 4394 | 0 | 5045 | 23951 |

BULGARIA

Statistical data submitted

The statistical data have been submitted by the National Veterinary Service.

Comments of the Bulgaria authorities

The National Veterinary Service (NVS) is the competent authority on animal welfare matters (AW) in Bulgaria. An organizational and implementation principle is that the AW requirements on the matters concerning animals used for experimental purposes must be performed by the 28 regional veterinary services (RVS) within the NVS. The requirements of Directive 86/609/EEC have been transposed into the national legislation, namely in Ordinance № 15 on the minimum requirements for protection and welfare of laboratory animals and the requirements to the establishments using, breeding and/or supplying such animals (in force since 01.05.2006; published in SG No. 17 of 24 February 2006) and in the Law for Veterinary Activities.

In Bulgaria, experiments involving usage of live animals are carried out only where it is not possible to apply any alternative method(s) of the same purpose and result.

The use of experimental animals is permitted only in establishments, that are authorized as being in compliance with the requirements laid down in Article 153 (1) of the Law on Veterinary Activity and which have official permit signed by the NVS Director-General. The NVS Director-General would issue the above mentioned permit on the basis of an ethical assessment and a positive opinion from the Animal Ethics Commission with NVS. The Animal Ethics Commission has been established as a permanently operating consultative body with the NVS Director-General. This Commission includes the following staff:

1. An official veterinary officer representing NVS; 
  
2. A veterinarian representing the Faculties of Veterinary Medicine; 
  
3. A physician of toxicological specialization representing Ministry of Health; 
  
4. A scientist or researcher of biological specialization representing Bulgarian Academy of Sciences; 
  
5. An environmental expert representing Ministry of Environment and Water; 
  
6. A zoologist representing the Biology Faculty at Sofia University; 
  
7. A physician representing the Medical University in Sofia; 
  
8. Two representatives of NGOs operating in the field of AW and protection of animals; 
  
9. A lawyer representing the Ministry of Agriculture and Food; 
  
10. A veterinarian representing the Ministry of Agriculture and Food.

The following experiments have been carried out in 2008 :

-Biological studies of a fundamental nature

-Research and development of products and devices for human medicine and dentistry and for veterinary medicine (R&D)

- Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine (T&S evaluations)

- Studies and Diagnosis of Human and Animal disease (S&D of disease)

- Education and training (E&T)

![](./../../../resource.html?uri=comnat:sec2010_1107en01_52.xhtml.59007.jpg)

Species use in percentage in Bulgaria

![](./../../../resource.html?uri=comnat:sec2010_1107en01_52.xhtml.59008.jpg)

The total number of animals used for experimental purposes was 32,581 in 2008 (mostly mice and hamsters). There have not been any non-human primates used for experimental purposes.

Experiments not permitted in Bulgaria:

1. for educational purposes, which cause death of animals; in educational establishments animal experiments shall be replaced by other methods for visualizing the subject taught in all cases where the use of animals might be replaced by other methods and if the aim is not to provide the students with specific practical skills.

2. if the result can be achieved with any method not involving the use of live animal(s);

3. if they use stray and/or domestic dogs or cats as experimental animals.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 16265 | 15820 |  |  | 445 |  |
| 1.b. | Rats (Rattus norvegicus) | 4513 | 3124 |  |  | 1389 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 3845 | 3807 |  |  | 38 |  |
| 1.d. | Hamsters (Mesocricetus ) | 182 | 112 |  |  | 70 |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 813 | 807 |  |  | 6 |  |
| 1.g. | Cats (Felis catus) | 11 | 11 |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 15 | 13 |  |  | 2 |  |
| 1.i. | Ferrets (Mustela putorius furo) | 0 |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) |  |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 17 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 137 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 80 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 250 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 126 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) | 0 |  |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 0 |  |  |  |  |  |
| 1.s. | Apes (Hominoidea) | 0 |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) |  |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 0 |  |  |  |  |  |
| 1.v. | Other birds (other Aves) | 1477 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 4800 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 50 |  |  |  |  |  |
| 1.z. | TOTAL | 32581 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 6197 | 108 | 7050 | 264 | 1964 |  | 682 |  | 16265 |
| 2.b. | Rats | 237 | 684 | 529 | 30 | 1080 |  | 1953 |  | 4513 |
| 2.c. | Guinea-Pigs | 4 | 634 | 2057 | 54 | 1000 |  | 96 |  | 3845 |
| 2.d. | Hamsters | 178 |  |  |  |  |  | 4 |  | 182 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits | 37 | 24 | 393 | 60 | 62 | 13 | 216 | 8 | 813 |
| 2.g. | Cats |  |  | 5 | 3 | 4 |  | 2 |  | 14 |
| 2.h. | Dogs | 2 |  |  |  |  |  | 10 |  | 12 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds |  |  |  |  |  |  | 17 |  | 17 |
| 2.l. | Pigs |  | 24 | 10 | 10 |  |  | 93 |  | 137 |
| 2.m. | Goats | 20 | 60 |  |  |  |  |  |  | 80 |
| 2.n. | Sheep | 16 | 46 |  |  |  | 15 | 173 |  | 250 |
| 2.o. | Cattle |  |  |  |  |  | 16 | 110 |  | 126 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals |  |  |  |  |  |  |  |  | 0 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds | 239 | 16 | 30 | 920 |  | 224 | 48 |  | 1477 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians | 200 |  |  |  |  |  | 4600 |  | 4800 |
| 2.y. | Fish |  |  |  |  |  |  | 50 |  | 50 |
| 2.z. | TOTAL | 7130 | 1596 | 10074 | 1341 | 4110 | 268 | 8054 | 8 | 32581 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 1900 |  |  |  |  | 64 |  |  |  | 1964 |
| 3.b. | Rats | 1080 |  |  |  |  |  |  |  |  | 1080 |
| 3.c. | Guinea-Pigs | 1000 |  |  |  |  |  |  |  |  | 1000 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 62 |  |  |  |  |  |  |  |  | 62 |
| 3.g. | Cats | 4 |  |  |  |  |  |  |  |  | 4 |
| 3.h. | Dogs |  |  |  |  |  |  |  |  |  | 0 |
| 3.i. | Ferrets |  |  |  |  |  |  |  |  |  | 0 |
| 3.j. | Other Carnivores |  |  |  |  |  |  |  |  |  | 0 |
| 3.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  | 0 |
| 3.l. | Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.m. | Goats |  |  |  |  |  |  |  |  |  | 0 |
| 3.n. | Sheep |  |  |  |  |  |  |  |  |  | 0 |
| 3.o. | Cattle |  |  |  |  |  |  |  |  |  | 0 |
| 3.p. | Prosimians |  |  |  |  |  |  |  |  |  | 0 |
| 3.q. | New World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.s. | Apes |  |  |  |  |  |  |  |  |  | 0 |
| 3.t. | Other Mammals |  |  |  |  |  |  |  |  |  | 0 |
| 3.u. | Quail |  |  |  |  |  |  |  |  |  | 0 |
| 3.v. | Other birds |  |  |  |  |  |  |  |  |  | 0 |
| 3.w. | Reptiles |  |  |  |  |  |  |  |  |  | 0 |
| 3.x. | Amphibians |  |  |  |  |  |  |  |  |  | 0 |
| 3.y. | Fish |  |  |  |  |  |  |  |  |  | 0 |
| 3.z. | TOTAL | 4046 | 0 | 0 | 0 | 0 | 64 | 0 | 0 | 0 | 4110 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice |  |  | 480 | 1800 |  | 2280 |
| 4.b. | Rats | 40 |  | 50 | 85 |  | 175 |
| 4.c. | Guinea-Pigs | 4 |  |  |  |  | 4 |
| 4.d. | Hamsters |  |  | 100 | 8 |  | 108 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits | 4 |  |  | 2 | 13 | 19 |
| 4.g. | Cats |  |  |  |  |  | 0 |
| 4.h. | Dogs |  |  |  |  |  | 0 |
| 4.i. | Ferrets |  |  |  |  |  | 0 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds |  |  |  |  |  | 0 |
| 4.l. | Pigs |  |  |  |  |  | 0 |
| 4.m. | Goats |  |  |  |  |  | 0 |
| 4.n. | Sheep |  |  |  |  | 15 | 15 |
| 4.o. | Cattle |  |  |  |  | 16 | 16 |
| 4.p. | Prosimians |  |  |  |  |  | 0 |
| 4.q. | New World Monkeys |  |  |  |  |  | 0 |
| 4.r. | Old World Monkeys |  |  |  |  |  | 0 |
| 4.s. | Apes |  |  |  |  |  | 0 |
| 4.t. | Other Mammals |  |  |  |  |  | 0 |
| 4.u. | Quail |  |  |  |  |  | 0 |
| 4.v. | Other birds |  |  |  | 9 | 254 | 263 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  |  |  |  |  | 0 |
| 4.y. | Fish |  |  |  |  |  | 0 |
| 4.z. | TOTAL | 48 | 0 | 630 | 1904 | 298 | 2880 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | |  | 7314 |  | |  |  |  | 7314 |
| 5.b. | Rats | | |  | 30 |  | |  |  | 529 | 559 |
| 5.c. | Guinea-Pigs | | |  | 2054 |  | |  |  | 57 | 2111 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | | 10 | 443 |  | |  |  |  | 453 |
| 5.g. | Cats | | |  | 5 |  | |  |  |  | 5 |
| 5.h. | Dogs | | | 3 |  |  | |  |  |  | 3 |
| 5.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 5.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 5.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 5.l. | Pigs | | |  | 10 |  | |  |  | 10 | 20 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 5.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 5.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 5.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 5.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 5.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 5.v. | Other birds | | | 30 | 920 |  | |  |  |  | 950 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 43 | 10776 | 0 | | 0 | 0 | 596 | 11415 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 150 | 1700 | 64 | |  |  | 50 | 1964 |
| 6.b. | Rats | | |  | 200 |  | |  |  | 780 | 980 |
| 6.c. | Guinea-Pigs | | | 100 | 1000 |  | |  |  |  | 1100 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | |  | 60 | 2 | |  |  |  | 62 |
| 6.g. | Cats | | |  |  | 4 | |  |  |  | 4 |
| 6.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 6.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 6.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 6.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 6.l. | Pigs | | |  |  |  | |  |  |  | 0 |
| 6.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 6.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 6.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 6.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 6.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 6.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 6.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 6.v. | Other birds | | |  |  |  | |  |  |  | 0 |
| 6.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 6.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 6.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 6.z. | TOTAL | | | 250 | 2960 | 70 | | 0 | 0 | 830 | 4110 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 1864 |  | 100 |  |  |  |  |  |  |  |  |  |  | 1964 |
| 7.b. | Rats | 900 | 130 | 50 |  |  |  |  |  |  |  |  |  |  | 1080 |
| 7.c. | Guinea-Pigs | 1000 |  |  |  |  |  |  |  |  |  |  |  |  | 1000 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits | 60 |  |  | 2 |  |  |  |  |  |  |  |  |  | 62 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  | 4 | 4 |
| 7.h. | Dogs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.i. | Ferrets |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.j. | Other Carnivores |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.l. | Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.m. | Goats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.n. | Sheep |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.o. | Cattle |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.p. | Prosimians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.q. | New World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.s. | Apes |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.t. | Other Mammals |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.u. | Quail |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.v. | Other birds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.w. | Reptiles |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.x. | Amphibians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.y. | Fish |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.z. | TOTAL | 3824 | 130 | 150 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4110 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 3760 | 130 | 150 | 2 |  |  |  |  |  |  |  |  | 4 | 4046 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.c. | Products/substances used or intended to be used mainly in industry |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.d. | Products/substances used or intended to be used mainly in the household |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 64 |  |  |  |  |  |  |  |  |  |  |  |  | 64 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.i. | Other toxicological or safety evaluations |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.j. | TOTAL | 3824 | 130 | 150 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4110 |

CZECH REPUBLIC

Statistical data submitted

The statistical data have been submitted by the “Central Commission for Animal Welfare (Ústřední komise pro ochranu zvířat)”.

Comments of the Czech authorities

Protection of animals and animal welfare in the Czech Republic (CR) is the responsibility of the Ministry of Agriculture (Ministerstvo zemědělství). The Central Commission for Animal Welfare (Ústřední komise pro ochranu zvířat) has changed to the technical advisory board of the Minister of Agriculture. The animal welfare activities are implemented pursuant to Act No. 246/1992 Coll., on the protection of animals against cruelty, as amended. The supervision of these matters has been the responsibility of the Regional Veterinary Administrations’ inspectors in 13 regions of the CR and the Municipal Veterinary Administration in Prague.

Altogether 132 inspections of experiments on animals were carried out in 2008, involving 77,694 animals. In 2 cases a penalty was imposed due to detected shortcomings.

Note: The Czech tables below, which were used for calculating the EU totals in the Sixth Report, do not include animals used by the Czech Academy of Sciences (CAS) due to the death of the responsible person at the time of data collection. However, these additional animals are included in the comments below.

In CAS 49,667 animals (32,995 mice, 10,106 rats, 733 guinea pigs, 56 other rodents, 299 pigs, 2,178 birds, 3,300 fish) were used and should be added to the tables provided below.

Therefore, in 2008 a total of 350,380 animals were used for experimental and other scientific purposes in the CR. It should be pointed out that 40,58% of it is represented by ringed birds (142,200 birds) since pursuant to the relevant Czech legislation even bird ringing is an experiment.

Of the remaining 208,180 animals used for experimental and scientific purposes only 0,02% were cats (45 cats), 0,26% dogs (552 dogs), 0,04% monkeys (80 monkeys), while no apes were used. Rodents and rabbits (62,39%, i.e. 129,887 animals) and fish (27,93%, i.e. 58,136 fish) represent the prevailing majority of animals used.

In the last couple of years the number of experimental animals used in the CR was approximately the same (approximately 220,000 animals excluding ringed birds). Fluctuations in numbers, if any, are caused by experiments using fish and poultry because these experiments are usually conducted on a large group of animals (a flock in houses or stock in water reservoirs).

The use of alternative methods to experiments on animals has been pushed through in the CR. Persons who manage, control and conduct experiments on animals are obliged to seek in the registers of validated alternative methods such methods which are applicable to their experiment. In the experimental project the applicant shall declare in writing that no validated alternative method can be applied for the given purpose.

The training courses for persons who manage, control and conduct experiments on animals comprise also teaching of alternative methods to experiments on animals.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 54776 | 51832 | 2888 |  | 56 |  |
| 1.b. | Rats (Rattus norvegicus) | 21531 | 20600 | 931 |  |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 1902 | 1902 |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 251 | 251 |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) | 1233 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 6304 | 6263 | 14 |  | 27 | 47 |
| 1.g. | Cats (Felis catus) | 45 | 15 | 30 |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 552 | 478 | 30 |  | 44 | 18 |
| 1.i. | Ferrets (Mustela putorius furo) | 122 | 122 |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) | 45 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 378 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 2013 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 174 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 1148 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 799 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) | 0 |  |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 80 | 80 |  |  |  | 59 |
| 1.s. | Apes (Hominoidea) | 0 |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) | 1774 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 0 |  |  |  |  |  |
| 1.v. | Other birds (other Aves) | 148722 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 1012 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 3016 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 54836 |  |  |  |  |  |
| 1.z. | TOTAL | 300713 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 14326 | 9138 | 2019 | 15795 | 703 | 6172 | 550 | 6073 | 54776 |
| 2.b. | Rats | 9878 | 4523 | 133 | 1260 | 3270 | 3 | 2359 | 105 | 21531 |
| 2.c. | Guinea-Pigs | 169 | 545 | 39 | 905 | 132 | 35 | 77 |  | 1902 |
| 2.d. | Hamsters | 14 | 180 |  |  |  |  | 57 |  | 251 |
| 2.e. | Other Rodents | 1125 |  |  |  |  |  | 83 | 25 | 1233 |
| 2.f. | Rabbits | 918 | 467 | 122 | 3533 | 202 | 217 | 780 | 65 | 6304 |
| 2.g. | Cats |  | 30 |  | 15 |  |  |  |  | 45 |
| 2.h. | Dogs | 44 | 335 |  | 18 | 151 | 2 | 2 |  | 552 |
| 2.i. | Ferrets |  | 118 |  |  |  | 4 |  |  | 122 |
| 2.j. | Other Carnivores | 9 | 36 |  |  |  |  |  |  | 45 |
| 2.k. | Horses, donkeys and cross breds | 19 | 30 |  | 306 |  |  | 13 | 10 | 378 |
| 2.l. | Pigs | 1146 | 208 |  | 468 | 100 | 8 | 83 |  | 2013 |
| 2.m. | Goats | 32 | 23 |  |  |  |  | 119 |  | 174 |
| 2.n. | Sheep | 108 |  |  | 100 |  | 250 | 65 | 625 | 1148 |
| 2.o. | Cattle | 54 | 29 |  | 332 | 4 | 162 | 184 | 34 | 799 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  | 80 |  |  |  |  |  |  | 80 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals | 1774 |  |  |  |  |  |  |  | 1774 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds | 146422 | 594 |  | 506 | 746 | 54 | 371 | 29 | 148722 |
| 2.w. | Reptiles | 958 |  |  |  |  |  | 54 |  | 1012 |
| 2.x. | Amphibians | 2915 |  |  |  |  |  | 101 |  | 3016 |
| 2.y. | Fish | 16894 |  |  | 90 | 37402 | 300 | 150 |  | 54836 |
| 2.z. | TOTAL | 196805 | 16336 | 2313 | 23328 | 42710 | 7207 | 5048 | 6966 | 300713 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 553 | 8 | 155 |  |  |  |  | 45 |  | 761 |
| 3.b. | Rats | 947 | 405 | 1825 |  |  |  |  | 54 |  | 3231 |
| 3.c. | Guinea-Pigs | 71 |  | 100 |  |  |  |  |  |  | 171 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 142 | 24 | 60 |  |  | 2 |  | 12 |  | 240 |
| 3.g. | Cats |  |  |  |  |  |  |  |  |  | 0 |
| 3.h. | Dogs | 151 |  |  |  |  |  |  |  |  | 151 |
| 3.i. | Ferrets |  |  |  |  |  |  |  |  |  | 0 |
| 3.j. | Other Carnivores |  |  |  |  |  |  |  |  |  | 0 |
| 3.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  | 0 |
| 3.l. | Pigs |  | 8 |  |  |  | 100 |  |  |  | 108 |
| 3.m. | Goats |  |  |  |  |  |  |  |  |  | 0 |
| 3.n. | Sheep |  |  |  |  |  |  |  |  |  | 0 |
| 3.o. | Cattle |  | 4 |  |  |  |  |  |  |  | 4 |
| 3.p. | Prosimians |  |  |  |  |  |  |  |  |  | 0 |
| 3.q. | New World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.s. | Apes |  |  |  |  |  |  |  |  |  | 0 |
| 3.t. | Other Mammals |  | 210 |  |  |  |  |  |  |  | 210 |
| 3.u. | Quail |  |  |  |  |  |  |  |  |  | 0 |
| 3.v. | Other birds | 349 | 48 |  |  |  |  |  |  |  | 397 |
| 3.w. | Reptiles |  |  |  |  |  |  |  |  |  | 0 |
| 3.x. | Amphibians |  |  |  |  |  |  |  |  |  | 0 |
| 3.y. | Fish | 305 | 677 | 1945 | 549 | 422 | 523 |  | 32066 | 950 | 37437 |
| 3.z. | TOTAL | 2518 | 1384 | 4085 | 549 | 422 | 625 | 0 | 32177 | 950 | 42710 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 185 | 181 | 6411 | 10073 | 2945 | 19795 |
| 4.b. | Rats | 2629 | 1865 | 1996 | 1901 | 2803 | 11194 |
| 4.c. | Guinea-Pigs |  |  | 12 | 135 |  | 147 |
| 4.d. | Hamsters |  |  |  | 52 |  | 52 |
| 4.e. | Other Rodents |  |  |  |  | 35 | 35 |
| 4.f. | Rabbits | 134 |  | 60 | 118 | 281 | 593 |
| 4.g. | Cats |  |  |  |  |  | 0 |
| 4.h. | Dogs | 39 | 2 |  | 2 | 42 | 85 |
| 4.i. | Ferrets |  |  |  | 122 |  | 122 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds |  |  |  |  | 7 | 7 |
| 4.l. | Pigs | 102 |  |  | 3 | 537 | 642 |
| 4.m. | Goats |  |  |  |  | 147 | 147 |
| 4.n. | Sheep | 18 |  |  | 250 | 37 | 305 |
| 4.o. | Cattle |  |  |  |  | 114 | 114 |
| 4.p. | Prosimians |  |  |  |  |  | 0 |
| 4.q. | New World Monkeys |  |  |  |  |  | 0 |
| 4.r. | Old World Monkeys | 31 |  |  | 49 |  | 80 |
| 4.s. | Apes |  |  |  |  |  | 0 |
| 4.t. | Other Mammals |  |  |  | 10 |  | 10 |
| 4.u. | Quail |  |  |  |  |  | 0 |
| 4.v. | Other birds |  |  |  | 212 | 1641 | 1853 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  |  |  |  |  | 0 |
| 4.y. | Fish |  |  |  |  | 1925 | 1925 |
| 4.z. | TOTAL | 3138 | 2048 | 8479 | 12927 | 10514 | 37106 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | | 5884 | 11930 |  | |  |  |  | 17814 |
| 5.b. | Rats | | | 67 | 1260 |  | | 66 |  |  | 1393 |
| 5.c. | Guinea-Pigs | | | 180 | 741 |  | |  |  |  | 921 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | | 88 | 3490 |  | |  |  |  | 3578 |
| 5.g. | Cats | | |  | 15 |  | |  |  |  | 15 |
| 5.h. | Dogs | | |  | 18 |  | |  |  |  | 18 |
| 5.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 5.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 292 | 14 |  | |  |  |  | 306 |
| 5.l. | Pigs | | | 46 | 422 |  | |  |  |  | 468 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | | 3 | 97 |  | |  |  |  | 100 |
| 5.o. | Cattle | | |  | 332 |  | |  |  |  | 332 |
| 5.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 5.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 5.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 5.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 5.v. | Other birds | | | 48 | 458 |  | |  |  | 100 | 606 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | | 90 |  |  | |  |  |  | 90 |
| 5.z. | TOTAL | | | 6698 | 18777 | 0 | | 66 | 0 | 100 | 25641 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 511 |  |  | |  |  | 192 | 703 |
| 6.b. | Rats | | | 2755 | 41 |  | |  |  | 474 | 3270 |
| 6.c. | Guinea-Pigs | | | 100 | 32 |  | |  |  |  | 132 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | | 171 | 12 |  | |  |  | 19 | 202 |
| 6.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 6.h. | Dogs | | | 151 |  |  | |  |  |  | 151 |
| 6.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 6.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 6.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 6.l. | Pigs | | |  |  |  | |  |  | 100 | 100 |
| 6.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 6.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 6.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 6.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 6.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 6.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 6.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 6.v. | Other birds | | |  |  |  | |  |  | 670 | 670 |
| 6.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 6.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 6.y. | Fish | | | 24468 | 9179 |  | |  |  | 3835 | 37482 |
| 6.z. | TOTAL | | | 28156 | 9264 | 0 | | 0 | 0 | 5290 | 42710 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  | 506 |  |  | 155 |  |  |  |  |  |  |  | 42 | 703 |
| 7.b. | Rats | 337 |  | 718 |  | 12 |  | 679 |  | 387 | 115 | 532 |  | 490 | 3270 |
| 7.c. | Guinea-Pigs |  |  |  | 10 | 116 | 6 |  |  |  |  |  |  |  | 132 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  | 97 | 19 | 26 |  |  |  |  |  |  | 60 | 202 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.h. | Dogs | 15 |  |  |  |  |  | 80 |  |  |  |  |  | 56 | 151 |
| 7.i. | Ferrets |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.j. | Other Carnivores |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.l. | Pigs |  |  |  |  |  |  |  |  |  |  |  |  | 100 | 100 |
| 7.m. | Goats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.n. | Sheep |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.o. | Cattle |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.p. | Prosimians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.q. | New World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.s. | Apes |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.t. | Other Mammals |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.u. | Quail |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.v. | Other birds |  |  |  |  |  |  |  |  |  |  |  |  | 670 | 670 |
| 7.w. | Reptiles |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.x. | Amphibians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.y. | Fish | 33782 |  |  |  |  |  |  |  |  |  |  | 3700 |  | 37482 |
| 7.z. | TOTAL | 34134 | 506 | 718 | 107 | 302 | 32 | 759 | 0 | 387 | 115 | 532 | 3700 | 1418 | 42710 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 255 | 506 |  | 68 | 35 | 11 | 477 |  |  |  |  | 138 | 1028 | 2518 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 750 |  | 400 |  | 12 |  | 12 |  |  |  |  |  | 210 | 1384 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 1067 |  | 318 | 39 | 255 | 21 | 270 |  | 387 | 95 | 532 | 975 | 126 | 4085 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 549 |  |  |  |  |  |  |  |  |  |  |  |  | 549 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 422 |  |  |  |  |  |  |  |  |  |  |  |  | 422 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption |  |  |  |  |  |  |  | 625 |  |  |  |  |  | 625 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 30421 |  |  |  |  |  |  |  |  | 20 | 45 | 1637 | 54 | 32177 |
| 8.i. | Other toxicological or safety evaluations |  |  |  |  |  |  |  |  |  |  |  | 950 |  | 950 |
| 8.j. | TOTAL | 33464 | 506 | 718 | 107 | 302 | 32 | 759 | 625 | 387 | 115 | 577 | 3700 | 1418 | 42710 |

DENMARK

Statistical data submitted

The statistical data have been submitted by the “Dyreforsøgstilsynet” (Animal Experiments Inspectorate).

Comments of Danish authorities

None

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 168164 | 119674 | 44406 | 337 | 3747 |  |
| 1.b. | Rats (Rattus norvegicus) | 75850 | 42343 | 30618 | 687 | 2202 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 5343 | 703 | 4640 | 0 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 4 | 4 | 0 | 0 | 0 |  |
| 1.e. | Other Rodents (other Rodentia) | 1760 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 2931 | 758 | 1044 | 0 | 1129 | 140 |
| 1.g. | Cats (Felis catus) | 154 | 0 | 17 | 4 | 133 | 0 |
| 1.h. | Dogs (Canis familiaris) | 271 | 0 | 250 | 0 | 21 | 39 |
| 1.i. | Ferrets (Mustela putorius furo) | 117 | 97 | 20 | 0 | 0 | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 101 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 54 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 6863 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 107 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 88 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 939 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.q. | New World Monkeys (Ceboidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. | Other Mammals (other Mammalia) | 243 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 0 | 0 | 0 | 0 | 0 |  |
| 1.v. | Other birds (other Aves) | 2820 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 221 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 293 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 31245 |  |  |  |  |  |
| 1.z. | TOTAL | 297568 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 53293 | 82439 | 11900 | 155 | 4923 | 2932 | 1096 | 11426 | 168164 |
| 2.b. | Rats | 15346 | 45628 | 3244 | 0 | 7269 | 833 | 2628 | 902 | 75850 |
| 2.c. | Guinea-Pigs | 207 | 2017 | 1695 | 25 | 1311 | 76 | 12 | 0 | 5343 |
| 2.d. | Hamsters | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| 2.e. | Other Rodents | 62 | 1698 | 0 | 0 | 0 | 0 | 0 | 0 | 1760 |
| 2.f. | Rabbits | 357 | 1808 | 447 | 4 | 218 | 2 | 42 | 53 | 2931 |
| 2.g. | Cats | 123 | 0 | 0 | 0 | 0 | 10 | 0 | 21 | 154 |
| 2.h. | Dogs | 1 | 119 | 0 | 0 | 130 | 21 | 0 | 0 | 271 |
| 2.i. | Ferrets | 97 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 117 |
| 2.j. | Other Carnivores | 62 | 39 | 0 | 0 | 0 | 0 | 0 | 0 | 101 |
| 2.k. | Horses, donkeys and cross breds | 15 | 13 | 7 | 0 | 0 | 0 | 19 | 0 | 54 |
| 2.l. | Pigs | 2245 | 1862 | 0 | 43 | 648 | 102 | 1029 | 934 | 6863 |
| 2.m. | Goats | 0 | 93 | 0 | 0 | 0 | 0 | 0 | 14 | 107 |
| 2.n. | Sheep | 5 | 38 | 26 | 6 | 0 | 0 | 13 | 0 | 88 |
| 2.o. | Cattle | 616 | 124 | 0 | 18 | 0 | 131 | 50 | 0 | 939 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 233 | 0 | 0 | 0 | 0 | 0 | 10 | 0 | 243 |
| 2.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.v. | Other birds | 2604 | 111 | 2 | 84 | 6 | 13 | 0 | 0 | 2820 |
| 2.w. | Reptiles | 198 | 23 | 0 | 0 | 0 | 0 | 0 | 0 | 221 |
| 2.x. | Amphibians | 92 | 65 | 0 | 0 | 0 | 136 | 0 | 0 | 293 |
| 2.y. | Fish | 5939 | 16602 | 0 | 0 | 8443 | 0 | 261 | 0 | 31245 |
| 2.z. | TOTAL | 81499 | 152699 | 17321 | 335 | 22948 | 4256 | 5160 | 13350 | 297568 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 2845 | 0 | 537 | 0 | 0 | 62 | 0 | 439 | 1040 | 4923 |
| 3.b. | Rats | 4515 | 74 | 0 | 1346 | 0 | 120 | 0 | 127 | 1087 | 7269 |
| 3.c. | Guinea-Pigs | 1260 | 0 | 0 | 0 | 0 | 24 | 0 | 0 | 27 | 1311 |
| 3.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 215 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 218 |
| 3.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.h. | Dogs | 130 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 130 |
| 3.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.l. | Pigs | 648 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 648 |
| 3.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| 3.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.y. | Fish | 0 | 0 | 493 | 0 | 0 | 0 | 7950 | 0 | 0 | 8443 |
| 3.z. | TOTAL | 9613 | 74 | 1030 | 1346 | 0 | 209 | 7950 | 566 | 2160 | 22948 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 2802 | 59758 | 13426 | 35581 | 1150 | 112717 |
| 4.b. | Rats | 2075 | 34100 | 823 | 19699 | 40 | 56737 |
| 4.c. | Guinea-Pigs | 269 | 1700 | 0 | 194 | 0 | 2163 |
| 4.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.e. | Other Rodents | 0 | 1416 | 0 | 282 | 24 | 1722 |
| 4.f. | Rabbits | 199 | 0 | 1129 | 757 | 21 | 2106 |
| 4.g. | Cats | 0 | 0 | 0 | 0 | 85 | 85 |
| 4.h. | Dogs | 21 | 39 | 0 | 80 | 0 | 140 |
| 4.i. | Ferrets | 0 | 20 | 0 | 97 | 0 | 117 |
| 4.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 15 | 15 |
| 4.l. | Pigs | 471 | 179 | 0 | 1869 | 111 | 2630 |
| 4.m. | Goats | 0 | 0 | 87 | 6 | 0 | 93 |
| 4.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.o. | Cattle | 0 | 0 | 0 | 79 | 36 | 115 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 0 | 0 | 0 | 0 | 130 | 130 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.v. | Other birds | 64 | 0 | 0 | 0 | 240 | 304 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.x. | Amphibians | 0 | 151 | 0 | 0 | 0 | 151 |
| 4.y. | Fish | 0 | 8165 | 0 | 0 | 1180 | 9345 |
| 4.z. | TOTAL | 5901 | 105528 | 15465 | 58644 | 3032 | 188570 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | | 155 | 14 | 0 | | 0 | 11870 | 16 | 12055 |
| 5.b. | Rats | | | 0 | 2408 | 0 | | 0 | 836 | 0 | 3244 |
| 5.c. | Guinea-Pigs | | | 25 | 0 | 0 | | 0 | 1310 | 385 | 1720 |
| 5.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 4 | 0 | 0 | | 28 | 22 | 397 | 451 |
| 5.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.h. | Dogs | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 7 | 7 |
| 5.l. | Pigs | | | 43 | 0 | 0 | | 0 | 0 | 0 | 43 |
| 5.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.n. | Sheep | | | 6 | 0 | 0 | | 0 | 0 | 26 | 32 |
| 5.o. | Cattle | | | 18 | 0 | 0 | | 0 | 0 | 0 | 18 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 84 | 0 | 0 | | 0 | 0 | 2 | 86 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 335 | 2422 | 0 | | 28 | 14038 | 833 | 17656 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 667 | 0 | 0 | | 0 | 2366 | 1890 | 4923 |
| 6.b. | Rats | | | 98 | 0 | 0 | | 50 | 4502 | 2619 | 7269 |
| 6.c. | Guinea-Pigs | | | 0 | 0 | 0 | | 72 | 1188 | 51 | 1311 |
| 6.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 0 | 0 | 0 | | 0 | 216 | 2 | 218 |
| 6.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.h. | Dogs | | | 0 | 0 | 0 | | 0 | 130 | 0 | 130 |
| 6.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.l. | Pigs | | | 0 | 0 | 0 | | 0 | 648 | 0 | 648 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.o. | Cattle | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 6 | 0 | 0 | | 0 | 0 | 0 | 6 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 493 | 0 | 0 | | 0 | 0 | 7950 | 8443 |
| 6.z. | TOTAL | | | 1264 | 0 | 0 | | 122 | 9050 | 12512 | 22948 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 0 | 0 | 1955 | 0 | 931 | 0 | 382 | 0 | 0 | 658 | 45 | 0 | 952 | 4923 |
| 7.b. | Rats | 0 | 0 | 1146 | 0 | 0 | 0 | 3146 | 0 | 0 | 174 | 2372 | 0 | 431 | 7269 |
| 7.c. | Guinea-Pigs | 0 | 0 | 1223 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 88 | 1311 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 0 | 0 | 46 | 19 | 0 | 3 | 39 | 0 | 0 | 0 | 109 | 0 | 2 | 218 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.h. | Dogs | 0 | 0 | 0 | 0 | 0 | 0 | 126 | 0 | 0 | 0 | 0 | 0 | 4 | 130 |
| 7.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.l. | Pigs | 0 | 0 | 8 | 12 | 0 | 0 | 600 | 0 | 0 | 0 | 28 | 0 | 0 | 648 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.v. | Other birds | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
| 7.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.y. | Fish | 199 | 7950 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 294 | 0 | 8443 |
| 7.z. | TOTAL | 199 | 7950 | 4384 | 31 | 931 | 3 | 4293 | 0 | 0 | 832 | 2554 | 294 | 1477 | 22948 |

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 125 | 0 | 4027 | 31 | 407 | 0 | 4366 | 0 | 0 | 148 | 401 | 0 | 108 | 9613 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 0 | 0 | 0 | 0 | 0 | 0 | 18 | 0 | 0 | 0 | 56 | 0 | 0 | 74 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 199 | 0 | 0 | 0 | 188 | 0 | 294 | 0 | 0 | 0 | 45 | 0 | 304 | 1030 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1016 | 0 | 330 | 1346 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 0 | 0 | 0 | 0 | 0 | 3 | 120 | 0 | 0 | 0 | 0 | 0 | 86 | 209 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 7950 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7950 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 566 | 0 | 0 | 0 | 566 |
| 8.i. | Other toxicological or safety evaluations | 0 | 0 | 21 | 0 | 336 | 0 | 0 | 0 | 0 | 118 | 1041 | 0 | 644 | 2160 |
| 8.j. | TOTAL | 324 | 7950 | 4048 | 31 | 931 | 3 | 4798 | 0 | 0 | 832 | 2559 | 0 | 1472 | 22948 |

GERMANY

Statistical data submitted

The statistical data have been submitted by the "Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft" (Federal Ministry for Consumer protection, Food and Agriculture).

Comments of German authorities

The German Government's aim is to reduce to an unavoidable minimum the number of animals used for experimental and other scientific purposes. In the current state of the art, however, despite the increased use of alternative methods it is not yet possible to dispense with animal experiments entirely. This applies to medical research in particular.

Within the EU, Germany is making a major contribution towards the development of test methods which do not involve animal experiments. A leading part in this process is played both by the Federal Ministry of Education and Research, with its scheme to promote the development of methods to replace animal experiments and by the Central Office for the registration and assessment of methods replacing and supplementing animal experiments, which this year is celebrating its 20th anniversary.

Compared with the previous year, in 2008 in Germany the number of vertebrates used for experimental and other scientific purposes increased by 2,1% to 2,021,782. Whereas the number of mice used increased by 135,459 the number of fish used fell by 95,565.

At almost 87%, rodents constitute the largest group of animals used in experiments. In particular, mice account for 65% and rats for 19%.

The next largest groups comprise rabbits at 4,8%, fish at 3,3% and birds at 2,8%. All other species taken together account for 2,2% of the animals used.

Compared with the previous year, the number of Old World monkeys, New World monkeys and prosimians fell by 152 to 2,263. The largest proportion of these animals (1,858) was used for toxicological tests and other safety tests on products and appliances for human, dental and veterinary medicine. Apes were not used.

Compared with 2007, the number of dogs and cats used fell by 340; the total number corresponded roughly to the numbers for 2000 to 2006.

For basic biological research the number of fish used fell by 88,760 and the number of rats by 18,122. By contrast, the number of mice rose by 41,775 and the number of amphibians by 5,676. In total, 68,519 fewer animals were used in basic biological research (-7,3%).

For the research and development of products and for the manufacture and/or quality control of products for human, dental and veterinary medicine, 858,395 animals were used – an increase of 
  
122,052 compared with the previous year. By contrast, in 2007, 97,770 fewer animals were used than in 2006. In the years 2001 to 2005 the number of animals used for these purposes was likewise within this range.

For toxicological tests and other safety tests on products and appliances for human, dental and veterinary medicine, 8,432 more animals were required than in 2007.

For products or substances used primarily in cosmetics or toiletries, no toxicological tests were carried out on animals in 2008 in Germany.

The proportion of animals used for research into human or animal diseases fell in 2008 compared with the previous year from 58,5% to 56,1%.

24,6% of the animals were used for legally required experiments in the manufacture or quality control of products for human, dental or veterinary medicine and/or for toxicological safety tests. Their proportion therefore increased by 5,0%.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 1.314.493 | 1.167.335 | 129.636 | 10.760 | 6.762 |  |
| 1.b. | Rats (Rattus norvegicus) | 390.853 | 305.309 | 79.003 | 5.395 | 1.146 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 35.870 | 35.624 | 246 | 0 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 7.061 | 6.782 | 149 | 0 | 130 |  |
| 1.e. | Other Rodents (other Rodentia) | 8.392 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 97.938 | 97.313 | 621 | 4 | 0 | 9.076 |
| 1.g. | Cats (Felis catus) | 798 | 246 | 294 | 0 | 258 | 303 |
| 1.h. | Dogs (Canis familiaris) | 4.450 | 1.911 | 1.536 | 0 | 1.003 | 1.081 |
| 1.i. | Ferrets (Mustela putorius furo) | 55 | 11 | 44 | 0 | 0 | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 410 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 584 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 12.361 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 531 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 4.638 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 6.252 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 543 | 0 | 543 | 0 | 0 | 0 |
| 1.q. | New World Monkeys (Ceboidea) | 305 | 252 | 48 | 5 | 0 | 63 |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 1.415 | 102 | 205 | 0 | 1.108 | 396 |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. | Other Mammals (other Mammalia) | 541 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 1.803 | 1.803 | 0 | 0 | 0 |  |
| 1.v. | Other birds (other Aves) | 53.986 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 192 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 10.815 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 67.496 |  |  |  |  |  |
| 1.z. | TOTAL | 2.021.782 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 723.037 | 273.935 | 148.754 | 41.668 | 75.985 | 7.855 | 26.200 | 17.059 | 1.314.493 |
| 2.b. | Rats | 74.880 | 180.418 | 51.412 | 10.468 | 53.312 | 1.609 | 16.248 | 2.506 | 390.853 |
| 2.c. | Guinea-Pigs | 936 | 6.002 | 16.870 | 3.700 | 6.623 | 18 | 616 | 1.105 | 35.870 |
| 2.d. | Hamsters | 2.036 | 2.822 | 16 | 1.331 | 40 | 52 | 295 | 469 | 7.061 |
| 2.e. | Other Rodents | 3.497 | 3.934 | 0 | 0 | 0 | 17 | 391 | 553 | 8.392 |
| 2.f. | Rabbits | 2.453 | 5.387 | 50.713 | 1.809 | 4.483 | 791 | 196 | 32.106 | 97.938 |
| 2.g. | Cats | 79 | 547 | 39 | 10 | 98 | 0 | 13 | 12 | 798 |
| 2.h. | Dogs | 193 | 1.003 | 0 | 939 | 1.935 | 189 | 161 | 30 | 4.450 |
| 2.i. | Ferrets | 42 | 0 | 0 | 2 | 0 | 0 | 1 | 10 | 55 |
| 2.j. | Other Carnivores | 15 | 0 | 0 | 311 | 0 | 80 | 0 | 4 | 410 |
| 2.k. | Horses, donkeys and cross breds | 346 | 121 | 0 | 2 | 0 | 75 | 39 | 1 | 584 |
| 2.l. | Pigs | 2.633 | 5.918 | 29 | 447 | 352 | 693 | 2.079 | 210 | 12.361 |
| 2.m. | Goats | 225 | 271 | 11 | 2 | 4 | 10 | 2 | 6 | 531 |
| 2.n. | Sheep | 692 | 1.150 | 2.151 | 116 | 3 | 167 | 216 | 143 | 4.638 |
| 2.o. | Cattle | 4.295 | 528 | 22 | 436 | 33 | 622 | 282 | 34 | 6.252 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 543 | 0 | 0 | 0 | 543 |
| 2.q. | New World Monkeys | 49 | 91 | 0 | 0 | 147 | 0 | 0 | 18 | 305 |
| 2.r. | Old World Monkeys | 43 | 91 | 0 | 0 | 1.168 | 2 | 10 | 101 | 1.415 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 495 | 6 | 4 | 0 | 0 | 0 | 7 | 29 | 541 |
| 2.u. | Quail | 0 | 0 | 0 | 0 | 1.786 | 0 | 17 | 0 | 1.803 |
| 2.v. | Other birds | 7.095 | 29.863 | 307 | 11.714 | 885 | 2.245 | 462 | 1.415 | 53.986 |
| 2.w. | Reptiles | 151 | 21 | 0 | 0 | 0 | 0 | 20 | 0 | 192 |
| 2.x. | Amphibians | 9.477 | 234 | 0 | 0 | 4 | 0 | 1.064 | 36 | 10.815 |
| 2.y. | Fish | 34.405 | 2.730 | 0 | 40 | 23.853 | 2.421 | 3.571 | 476 | 67.496 |
| 2.z. | TOTAL | 867.074 | 515.072 | 270.328 | 72.995 | 171.254 | 16.846 | 51.890 | 56.323 | 2.021.782 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 61.040 | 4.146 | 10.375 | 0 | 0 | 0 | 0 | 217 | 207 | 75.985 |
| 3.b. | Rats | 33.080 | 8.284 | 11.425 | 16 | 0 | 0 | 0 | 239 | 268 | 53.312 |
| 3.c. | Guinea-Pigs | 3.613 | 1.449 | 1.482 | 0 | 0 | 0 | 0 | 0 | 79 | 6.623 |
| 3.d. | Hamsters | 40 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 40 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 2.861 | 952 | 633 | 0 | 0 | 0 | 0 | 0 | 37 | 4.483 |
| 3.g. | Cats | 88 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 98 |
| 3.h. | Dogs | 1.902 | 20 | 8 | 0 | 0 | 0 | 0 | 0 | 5 | 1.935 |
| 3.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.l. | Pigs | 352 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 352 |
| 3.m. | Goats | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| 3.n. | Sheep | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| 3.o. | Cattle | 33 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 33 |
| 3.p. | Prosimians | 543 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 543 |
| 3.q. | New World Monkeys | 147 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 147 |
| 3.r. | Old World Monkeys | 1.168 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.168 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 0 | 1.786 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.786 |
| 3.v. | Other birds | 182 | 577 | 0 | 0 | 0 | 0 | 44 | 0 | 82 | 885 |
| 3.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 |
| 3.y. | Fish | 3.855 | 14.681 | 2.367 | 0 | 0 | 0 | 80 | 2.870 | 0 | 23.853 |
| 3.z. | TOTAL | 108.907 | 31.899 | 26.290 | 16 | 0 | 0 | 124 | 3.326 | 692 | 171.254 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 60.950 | 105.707 | 107.646 | 388.614 | 5.404 | 668.321 |
| 4.b. | Rats | 16.279 | 26.241 | 4.369 | 87.061 | 1.014 | 134.964 |
| 4.c. | Guinea-Pigs | 130 | 47 | 0 | 4.271 | 239 | 4.687 |
| 4.d. | Hamsters | 387 | 825 | 98 | 2.531 | 45 | 3.886 |
| 4.e. | Other Rodents | 0 | 814 | 0 | 2.623 | 1.439 | 4.876 |
| 4.f. | Rabbits | 758 | 106 | 304 | 2.413 | 194 | 3.775 |
| 4.g. | Cats | 0 | 40 | 0 | 0 | 527 | 567 |
| 4.h. | Dogs | 3 | 0 | 75 | 84 | 765 | 927 |
| 4.i. | Ferrets | 0 | 0 | 0 | 35 | 0 | 35 |
| 4.j. | Other Carnivores | 0 | 0 | 0 | 2 | 80 | 82 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 43 | 294 | 337 |
| 4.l. | Pigs | 447 | 7 | 10 | 2.170 | 2.359 | 4.993 |
| 4.m. | Goats | 0 | 29 | 0 | 203 | 10 | 242 |
| 4.n. | Sheep | 59 | 48 | 0 | 528 | 919 | 1.554 |
| 4.o. | Cattle | 9 | 21 | 0 | 79 | 4.603 | 4.712 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 0 | 21 | 0 | 26 | 0 | 47 |
| 4.r. | Old World Monkeys | 4 | 16 | 0 | 80 | 0 | 100 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 0 | 44 | 0 | 42 | 0 | 86 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.v. | Other birds | 118 | 48 | 0 | 2.239 | 7.706 | 10.111 |
| 4.w. | Reptiles | 0 | 10 | 0 | 0 | 47 | 57 |
| 4.x. | Amphibians | 224 | 56 | 0 | 468 | 0 | 748 |
| 4.y. | Fish | 1.768 | 958 | 131 | 3.913 | 5.368 | 12.138 |
| 4.z. | TOTAL | 81.136 | 135.038 | 112.633 | 497.425 | 31.013 | 857.245 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | | 0 | 174.107 | 0 | | 850 | 11.320 | 4.145 | 190.422 |
| 5.b. | Rats | | | 0 | 61.747 | 0 | | 0 | 0 | 133 | 61.880 |
| 5.c. | Guinea-Pigs | | | 0 | 19.743 | 0 | | 512 | 0 | 315 | 20.570 |
| 5.d. | Hamsters | | | 0 | 1.347 | 0 | | 0 | 0 | 0 | 1.347 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 0 | 42.765 | 0 | | 0 | 8.697 | 1.060 | 52.522 |
| 5.g. | Cats | | | 0 | 39 | 0 | | 0 | 0 | 10 | 49 |
| 5.h. | Dogs | | | 0 | 217 | 0 | | 0 | 680 | 42 | 939 |
| 5.i. | Ferrets | | | 0 | 2 | 0 | | 0 | 0 | 0 | 2 |
| 5.j. | Other Carnivores | | | 0 | 311 | 0 | | 0 | 0 | 0 | 311 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 2 | 0 | | 0 | 0 | 0 | 2 |
| 5.l. | Pigs | | | 0 | 436 | 0 | | 0 | 0 | 40 | 476 |
| 5.m. | Goats | | | 0 | 0 | 0 | | 0 | 2 | 11 | 13 |
| 5.n. | Sheep | | | 0 | 0 | 0 | | 0 | 58 | 2.209 | 2.267 |
| 5.o. | Cattle | | | 0 | 412 | 0 | | 0 | 0 | 46 | 458 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 4 | 4 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 0 | 1.005 | 0 | | 0 | 10.158 | 858 | 12.021 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 40 | 0 | | 0 | 0 | 0 | 40 |
| 5.z. | TOTAL | | | 0 | 302.173 | 0 | | 1.362 | 30.915 | 8.873 | 343.323 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 153 | 55.706 | 0 | | 537 | 16.213 | 3.376 | 75.985 |
| 6.b. | Rats | | | 110 | 27.852 | 10 | | 16 | 21.608 | 3.716 | 53.312 |
| 6.c. | Guinea-Pigs | | | 0 | 4.117 | 0 | | 0 | 2.503 | 3 | 6.623 |
| 6.d. | Hamsters | | | 0 | 40 | 0 | | 0 | 0 | 0 | 40 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 0 | 3.515 | 0 | | 0 | 891 | 77 | 4.483 |
| 6.g. | Cats | | | 14 | 74 | 0 | | 0 | 0 | 10 | 98 |
| 6.h. | Dogs | | | 36 | 777 | 0 | | 0 | 1.093 | 29 | 1.935 |
| 6.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.l. | Pigs | | | 0 | 205 | 0 | | 0 | 135 | 12 | 352 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 4 | 0 | 4 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 3 | 3 |
| 6.o. | Cattle | | | 0 | 33 | 0 | | 0 | 0 | 0 | 33 |
| 6.p. | Prosimians | | | 0 | 543 | 0 | | 0 | 0 | 0 | 543 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 147 | 0 | 147 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 1.168 | 0 | 1.168 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 320 | 0 | | 0 | 1.466 | 0 | 1.786 |
| 6.v. | Other birds | | | 0 | 320 | 0 | | 0 | 483 | 82 | 885 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 4 | 4 |
| 6.y. | Fish | | | 1.270 | 8.128 | 0 | | 0 | 12.847 | 1.608 | 23.853 |
| 6.z. | TOTAL | | | 1.583 | 101.630 | 10 | | 553 | 58.558 | 8.920 | 171.254 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 28.611 | 8.594 | 12.390 | 70 | 9.944 | 0 | 1.804 | 1.068 | 0 | 6.227 | 0 | 0 | 7.277 | 75.985 |
| 7.b. | Rats | 2.510 | 5.884 | 18.972 | 25 | 0 | 0 | 5.704 | 0 | 3.393 | 3.974 | 5.647 | 0 | 7.203 | 53.312 |
| 7.c. | Guinea-Pigs | 0 | 0 | 843 | 0 | 5.653 | 0 | 0 | 0 | 0 | 0 | 15 | 0 | 112 | 6.623 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 40 | 40 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 28 | 18 | 171 | 925 | 0 | 479 | 0 | 0 | 925 | 0 | 1.426 | 0 | 511 | 4.483 |
| 7.g. | Cats | 0 | 0 | 24 | 0 | 0 | 0 | 62 | 0 | 0 | 0 | 0 | 0 | 12 | 98 |
| 7.h. | Dogs | 0 | 339 | 747 | 0 | 0 | 0 | 639 | 0 | 0 | 0 | 0 | 0 | 210 | 1.935 |
| 7.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.l. | Pigs | 0 | 11 | 88 | 0 | 0 | 0 | 34 | 0 | 0 | 0 | 0 | 0 | 219 | 352 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 |
| 7.o. | Cattle | 0 | 0 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 | 33 |
| 7.p. | Prosimians | 0 | 0 | 261 | 0 | 0 | 0 | 143 | 0 | 0 | 0 | 0 | 0 | 139 | 543 |
| 7.q. | New World Monkeys | 0 | 0 | 36 | 0 | 0 | 0 | 47 | 0 | 64 | 0 | 0 | 0 | 0 | 147 |
| 7.r. | Old World Monkeys | 0 | 0 | 184 | 0 | 0 | 0 | 750 | 0 | 176 | 0 | 58 | 0 | 0 | 1.168 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 459 | 217 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 176 | 0 | 934 | 1.786 |
| 7.v. | Other birds | 204 | 0 | 205 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 476 | 885 |
| 7.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 4 |
| 7.y. | Fish | 2.446 | 326 | 0 | 0 | 0 | 0 | 294 | 0 | 0 | 0 | 129 | 19.443 | 1.215 | 23.853 |
| 7.z. | TOTAL | 34.258 | 15.389 | 33.937 | 1.020 | 15.597 | 479 | 9.477 | 1.068 | 4.562 | 10.201 | 7.451 | 19.443 | 18.372 | 171.254 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 28.654 | 12.043 | 26.171 | 497 | 5.551 | 3 | 7.274 | 1.008 | 1.551 | 4.218 | 4.786 | 3.412 | 13.739 | 108.907 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 3.244 | 2.572 | 2.680 | 367 | 2.793 | 372 | 974 | 0 | 1.072 | 1.271 | 725 | 11.884 | 3.945 | 31.899 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 2.046 | 566 | 4.671 | 156 | 7.177 | 91 | 1.209 | 60 | 1.935 | 4.322 | 1.928 | 1.895 | 234 | 26.290 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 16 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 80 | 44 | 124 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 289 | 208 | 239 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 12 | 2.172 | 386 | 3.326 |
| 8.i. | Other toxicological or safety evaluations | 9 | 0 | 176 | 0 | 76 | 13 | 0 | 0 | 4 | 390 | 0 | 0 | 24 | 692 |
| 8.j. | TOTAL | 34.258 | 15.389 | 33.937 | 1.020 | 15.597 | 479 | 9.477 | 1.068 | 4.562 | 10.201 | 7.451 | 19.443 | 18.372 | 171.254 |

ESTONIA

Statistical data submitted

The statistical data have been submitted by the Animal Welfare and Zootechnics bureau of the Ministry of Agriculture

Comments of Estonian authorities

Estonia has 7 approved experimental animal breeding and user establishments. Four of them are active by the University of Tartu.

Commission of the authorization of the animal testing permits first started in August 2004. During the period 2005-2008 there have been issued over a 100 licenses for conducting animal experiments in Estonia. Most of the experiments have been conducted at the University of Tartu.

The majority of laboratory animals used are from authorized breeding establishments in Estonia.

The most of experiments have been carried out in the fields of biological studies of a fundamental nature and research and development of products and devices for human medicine.

In the field of biological studies, the majority of experiments involved the investigation of human diseases (nervous and mental illnesses, various forms of cancer).

The authorization and licensing animal testing and conducting animal experiments is regulated by national and EU legislation.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 28754 | 11779 | 13137 |  | 3838 |  |
| 1.b. | Rats (Rattus norvegicus) | 5268 | 2058 | 3210 | 0 | 0 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 22 |  | 22 |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 120 |  | 120 |  |  |  |
| 1.e. | Other Rodents (other Rodentia) | 0 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 630 | 0 | 630 | 0 | 0 | 0 |
| 1.g. | Cats (Felis catus) | 0 |  |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 0 |  |  |  |  |  |
| 1.i. | Ferrets (Mustela putorius furo) | 0 |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) | 0 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 0 |  |  |  |  |  |
| 1.l. | Pigs (Sus) |  |  |  |  |  |  |
| 1.m. | Goats (Capra) | 0 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) |  |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 0 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) | 0 |  |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 0 |  |  |  |  |  |
| 1.s. | Apes (Hominoidea) | 0 |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) |  |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 0 |  |  |  |  |  |
| 1.v. | Other birds (other Aves) |  |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) |  |  |  |  |  |  |
| 1.y. | Fish (Pisces) |  |  |  |  |  |  |
| 1.z. | TOTAL | 34794 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 24323 | 4291 | 100 |  | 40 |  |  |  | 28754 |
| 2.b. | Rats | 2870 | 2398 |  |  |  |  |  |  | 5268 |
| 2.c. | Guinea-Pigs |  |  |  |  |  | 22 |  |  | 22 |
| 2.d. | Hamsters | 15 | 105 |  |  |  |  |  |  | 120 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits | 510 | 120 |  |  |  |  |  |  | 630 |
| 2.g. | Cats |  |  |  |  |  |  |  |  | 0 |
| 2.h. | Dogs |  |  |  |  |  |  |  |  | 0 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  | 0 |
| 2.l. | Pigs |  |  |  |  |  |  |  |  | 0 |
| 2.m. | Goats |  |  |  |  |  |  |  |  | 0 |
| 2.n. | Sheep |  |  |  |  |  |  |  |  | 0 |
| 2.o. | Cattle |  |  |  |  |  |  |  |  | 0 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals |  |  |  |  |  |  |  |  | 0 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds |  |  |  |  |  |  |  |  | 0 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  | 0 |
| 2.y. | Fish |  |  |  |  |  |  |  |  | 0 |
| 2.z. | TOTAL | 27718 | 6914 | 100 | 0 | 40 | 22 | 0 | 0 | 34794 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice |  |  |  |  |  | 40 |  |  |  | 40 |
| 3.b. | Rats |  |  |  |  |  |  |  |  |  | 0 |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits |  |  |  |  |  |  |  |  |  | 0 |
| 3.g. | Cats |  |  |  |  |  |  |  |  |  | 0 |
| 3.h. | Dogs |  |  |  |  |  |  |  |  |  | 0 |
| 3.i. | Ferrets |  |  |  |  |  |  |  |  |  | 0 |
| 3.j. | Other Carnivores |  |  |  |  |  |  |  |  |  | 0 |
| 3.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  | 0 |
| 3.l. | Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.m. | Goats |  |  |  |  |  |  |  |  |  | 0 |
| 3.n. | Sheep |  |  |  |  |  |  |  |  |  | 0 |
| 3.o. | Cattle |  |  |  |  |  |  |  |  |  | 0 |
| 3.p. | Prosimians |  |  |  |  |  |  |  |  |  | 0 |
| 3.q. | New World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.s. | Apes |  |  |  |  |  |  |  |  |  | 0 |
| 3.t. | Other Mammals |  |  |  |  |  |  |  |  |  | 0 |
| 3.u. | Quail |  |  |  |  |  |  |  |  |  | 0 |
| 3.v. | Other birds |  |  |  |  |  |  |  |  |  | 0 |
| 3.w. | Reptiles |  |  |  |  |  |  |  |  |  | 0 |
| 3.x. | Amphibians |  |  |  |  |  |  |  |  |  | 0 |
| 3.y. | Fish |  |  |  |  |  |  |  |  |  | 0 |
| 3.z. | TOTAL | 0 | 0 | 0 | 0 | 0 | 40 | 0 | 0 | 0 | 40 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 621 | 11357 | 10124 | 6512 |  | 28614 |
| 4.b. | Rats | 510 | 3412 |  | 1346 |  | 5268 |
| 4.c. | Guinea-Pigs |  |  |  |  | 22 | 22 |
| 4.d. | Hamsters |  |  |  | 120 |  | 120 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits |  |  |  | 630 |  | 630 |
| 4.g. | Cats |  |  |  |  |  | 0 |
| 4.h. | Dogs |  |  |  |  |  | 0 |
| 4.i. | Ferrets |  |  |  |  |  | 0 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds |  |  |  |  |  | 0 |
| 4.l. | Pigs |  |  |  |  |  | 0 |
| 4.m. | Goats |  |  |  |  |  | 0 |
| 4.n. | Sheep |  |  |  |  |  | 0 |
| 4.o. | Cattle |  |  |  |  |  | 0 |
| 4.p. | Prosimians |  |  |  |  |  | 0 |
| 4.q. | New World Monkeys |  |  |  |  |  | 0 |
| 4.r. | Old World Monkeys |  |  |  |  |  | 0 |
| 4.s. | Apes |  |  |  |  |  | 0 |
| 4.t. | Other Mammals |  |  |  |  |  | 0 |
| 4.u. | Quail |  |  |  |  |  | 0 |
| 4.v. | Other birds |  |  |  |  |  | 0 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  |  |  |  |  | 0 |
| 4.y. | Fish |  |  |  |  |  | 0 |
| 4.z. | TOTAL | 1131 | 14769 | 10124 | 8608 | 22 | 34654 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

   Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | |  |  |  | |  | 100 |  | 100 |
| 5.b. | Rats | | |  |  |  | |  |  |  | 0 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | |  |  |  | |  |  |  | 0 |
| 5.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 5.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 5.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 5.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 5.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 5.l. | Pigs | | |  |  |  | |  |  |  | 0 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 5.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 5.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 5.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 5.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 5.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 5.v. | Other birds | | |  |  |  | |  |  |  | 0 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 0 | 0 | 0 | | 0 | 100 | 0 | 100 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | |  |  |  | |  | 40 |  | 40 |
| 6.b. | Rats | | |  |  |  | |  |  |  | 0 |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | |  |  |  | |  |  |  | 0 |
| 6.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 6.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 6.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 6.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 6.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 6.l. | Pigs | | |  |  |  | |  |  |  | 0 |
| 6.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 6.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 6.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 6.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 6.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 6.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 6.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 6.v. | Other birds | | |  |  |  | |  |  |  | 0 |
| 6.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 6.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 6.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 6.z. | TOTAL | | | 0 | 0 | 0 | | 0 | 40 | 0 | 40 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  |  | 40 |  |  |  |  |  |  |  |  |  |  | 40 |
| 7.b. | Rats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.h. | Dogs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.i. | Ferrets |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.j. | Other Carnivores |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.l. | Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.m. | Goats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.n. | Sheep |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.o. | Cattle |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.p. | Prosimians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.q. | New World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.s. | Apes |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.t. | Other Mammals |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.u. | Quail |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.v. | Other birds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.w. | Reptiles |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.x. | Amphibians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.y. | Fish |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.z. | TOTAL | 0 | 0 | 40 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 40 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.c. | Products/substances used or intended to be used mainly in industry |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.d. | Products/substances used or intended to be used mainly in the household |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption |  | 40 |  |  |  |  |  |  |  |  |  |  |  | 40 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.i. | Other toxicological or safety evaluations |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.j. | TOTAL | 0 | 40 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 40 |

IRELAND

Statistical data submitted

The statistical data for Ireland have been provided by the Department of Health and Children.

Comments of Irish authorities

A total of 112,835 animals were used. This represents an increase of 197% compared to 2005.

259 new licences were issued in 2008. This is an increase of 51% compared to 2005.

Rodents accounted for 74% of all animals used which compares to 67% in 2005.

Fish accounted for 20% of all animals.

No non-human primates were used. This was in accordance with Ireland’s policy not to licence for the use of non-human primates.

Of the animals used, 24% (26,609) were bred in registered breeding establishments in Ireland while 55% (62,003) came from other Member States in the EC.

Universities and Colleges accounted for 24% (27,198) of all animals used in scientific procedures.

Regulatory requirements (52,325) and studies related to human and animal diseases (40,233) accounted for 82% of all animals used in scientific procedures.

Animals Used for Selected Purposes

10% of animals (10,908) were involved in studies specific to animal diseases. Of the 224 pigs used in 2005, 88% (196) were involved in studies on human and animal diseases.

295 cats were used, 98 of which were used in toxicology and other safety evaluations.

557 dogs were used, 105 of which were used in toxicology and other safety evaluations.

59% (120) of rabbits used were for the study of human or animal diseases.

144 horses were used, a decrease of 45 since 2005. 69% of the horses used were for EC legislation including European Pharmacopoeia requirements.

Toxicological and other Safety Evaluations

No animals were used in the testing of cosmetic products. This was in accordance with Ireland’s policy not to licence procedures involving the testing of cosmetics.

Toxicological and other safety evaluations accounted for 46% (52,065) of animals used which compares with 18% in 2005.

99% of the animals used in toxicological and other safety evaluations were mice.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 71.224 | 12.271 | 57.264 | 1.009 | 680 |  |
| 1.b. | Rats (Rattus norvegicus) | 11.741 | 4.396 | 4.423 | 2.880 | 42 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 91 | 59 | 32 | 0 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 68 | 4 | 64 | 0 | 0 |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 204 | 6 | 198 | 0 | 0 | 0 |
| 1.g. | Cats (Felis catus) | 295 | 295 | 0 | 0 | 0 | 16 |
| 1.h. | Dogs (Canis familiaris) | 557 | 547 | 10 | 0 | 0 | 198 |
| 1.i. | Ferrets (Mustela putorius furo) |  |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) |  |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 144 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 224 |  |  |  |  |  |
| 1.m. | Goats (Capra) |  |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 456 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 4.019 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) |  |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) |  |  |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) |  |  |  |  |  |  |
| 1.s. | Apes (Hominoidea) |  |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) | 32 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) |  |  |  |  |  |  |
| 1.v. | Other birds (other Aves) | 582 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) |  |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 23.198 |  |  |  |  |  |
| 1.z. | TOTAL | 112.835 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 15.813 | 2.487 | 0 | 0 | 51.456 | 426 | 14 | 1.028 | 71.224 |
| 2.b. | Rats | 6.750 | 4.506 | 0 | 0 | 243 | 57 | 12 | 173 | 11.741 |
| 2.c. | Guinea-Pigs | 32 | 0 | 0 | 0 | 59 | 0 | 0 | 0 | 91 |
| 2.d. | Hamsters | 4 | 64 | 0 | 0 | 0 | 0 | 0 | 0 | 68 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits | 6 | 114 | 0 | 0 | 84 | 0 | 0 | 0 | 204 |
| 2.g. | Cats | 0 | 197 | 0 | 0 | 98 | 0 | 0 | 0 | 295 |
| 2.h. | Dogs | 0 | 442 | 0 | 0 | 105 | 0 | 0 | 10 | 557 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds | 21 | 0 | 0 | 99 | 0 | 3 | 13 | 8 | 144 |
| 2.l. | Pigs | 175 | 21 | 0 | 12 | 16 | 0 | 0 | 0 | 224 |
| 2.m. | Goats |  |  |  |  |  |  |  |  | 0 |
| 2.n. | Sheep | 282 | 2 | 0 | 10 | 0 | 120 | 42 | 0 | 456 |
| 2.o. | Cattle | 3.563 | 29 | 0 | 139 | 0 | 90 | 12 | 186 | 4.019 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals | 0 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 32 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds | 201 | 287 | 0 | 0 | 4 | 90 | 0 | 0 | 582 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  | 0 |
| 2.y. | Fish | 3.019 | 1.400 | 0 | 0 | 0 | 0 | 0 | 18.779 | 23.198 |
| 2.z. | TOTAL | 29.866 | 9.581 | 0 | 260 | 52.065 | 786 | 93 | 20.184 | 112.835 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 12 | 0 |  | 0 |  | 0 |  | 0 | 51.444 | 51.456 |
| 3.b. | Rats |  |  |  |  |  |  |  |  | 243 | 243 |
| 3.c. | Guinea-Pigs | 0 | 0 |  | 0 |  | 0 |  | 0 | 59 | 59 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits |  |  |  |  |  |  |  |  | 84 | 84 |
| 3.g. | Cats | 98 | 0 |  | 0 |  | 0 |  | 0 | 0 | 98 |
| 3.h. | Dogs | 105 | 0 |  | 0 |  | 0 |  | 0 | 0 | 105 |
| 3.i. | Ferrets |  |  |  |  |  |  |  |  |  | 0 |
| 3.j. | Other Carnivores |  |  |  |  |  |  |  |  |  | 0 |
| 3.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  | 0 |
| 3.l. | Pigs | 16 | 0 |  | 0 |  | 0 |  | 0 | 0 | 16 |
| 3.m. | Goats |  |  |  |  |  |  |  |  |  | 0 |
| 3.n. | Sheep |  |  |  |  |  |  |  |  |  | 0 |
| 3.o. | Cattle |  |  |  |  |  |  |  |  |  | 0 |
| 3.p. | Prosimians |  |  |  |  |  |  |  |  |  | 0 |
| 3.q. | New World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.s. | Apes |  |  |  |  |  |  |  |  |  | 0 |
| 3.t. | Other Mammals |  |  |  |  |  |  |  |  |  | 0 |
| 3.u. | Quail | 4 | 0 |  | 0 |  | 0 |  | 0 | 0 | 4 |
| 3.v. | Other birds |  |  |  |  |  |  |  |  |  | 0 |
| 3.w. | Reptiles |  |  |  |  |  |  |  |  |  | 0 |
| 3.x. | Amphibians |  |  |  |  |  |  |  |  |  | 0 |
| 3.y. | Fish |  |  |  |  |  |  |  |  |  | 0 |
| 3.z. | TOTAL | 235 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 51.830 | 52.065 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 770 | 5.534 | 2.374 | 9.030 | 1.018 | 18.726 |
| 4.b. | Rats | 1.525 | 7.778 | 42 | 1.840 | 128 | 11.313 |
| 4.c. | Guinea-Pigs | 0 | 0 | 0 | 32 | 0 | 32 |
| 4.d. | Hamsters | 0 | 0 | 0 | 64 | 4 | 68 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits | 49 | 0 | 0 | 69 | 2 | 120 |
| 4.g. | Cats | 0 | 0 | 0 | 0 | 197 | 197 |
| 4.h. | Dogs | 0 | 0 | 0 | 4 | 438 | 442 |
| 4.i. | Ferrets |  |  |  |  |  | 0 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds |  |  |  |  | 24 | 24 |
| 4.l. | Pigs | 94 |  | 43 | 0 | 59 | 196 |
| 4.m. | Goats |  |  |  |  |  | 0 |
| 4.n. | Sheep | 2 | 0 | 0 | 0 | 402 | 404 |
| 4.o. | Cattle | 0 | 0 | 0 | 0 | 3.682 | 3.682 |
| 4.p. | Prosimians |  |  |  |  |  | 0 |
| 4.q. | New World Monkeys |  |  |  |  |  | 0 |
| 4.r. | Old World Monkeys |  |  |  |  |  | 0 |
| 4.s. | Apes |  |  |  |  |  | 0 |
| 4.t. | Other Mammals |  |  |  |  | 32 | 32 |
| 4.u. | Quail |  |  |  |  |  | 0 |
| 4.v. | Other birds | 12 |  | 2 | 1 | 563 | 578 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  |  |  |  |  | 0 |
| 4.y. | Fish | 60 | 0 | 0 | 0 | 4.359 | 4.419 |
| 4.z. | TOTAL | 2.512 | 13.312 | 2.461 | 11.040 | 10.908 | 40.233 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | |  |  |  | |  |  |  | 0 |
| 5.b. | Rats | | |  |  |  | |  |  |  | 0 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | |  |  |  | |  |  |  | 0 |
| 5.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 5.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 5.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 5.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 99 | 0 | | 0 | 0 | 0 | 99 |
| 5.l. | Pigs | | | 12 | 0 | 0 | | 0 | 0 | 0 | 12 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | | 0 | 10 | 0 | | 0 | 0 | 0 | 10 |
| 5.o. | Cattle | | | 0 | 91 | 0 | | 0 | 0 | 48 | 139 |
| 5.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 5.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 5.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 5.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 5.v. | Other birds | | |  |  |  | |  |  |  | 0 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 12 | 200 | 0 | | 0 | 0 | 48 | 260 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 0 | 5.106 | 0 | | 0 | 46.328 | 22 | 51.456 |
| 6.b. | Rats | | | 15 | 0 | 0 | | 0 | 228 | 0 | 243 |
| 6.c. | Guinea-Pigs | | | 0 | 0 | 0 | | 0 | 59 | 0 | 59 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | | 0 | 0 | 0 | | 0 | 84 | 0 | 84 |
| 6.g. | Cats | | | 83 | 15 | 0 | | 0 | 0 | 0 | 98 |
| 6.h. | Dogs | | | 57 | 48 | 0 | | 0 | 0 | 0 | 105 |
| 6.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 6.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 6.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 6.l. | Pigs | | | 16 | 0 | 0 | | 0 | 0 | 0 | 16 |
| 6.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 6.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 6.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 6.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 6.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 6.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 6.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 6.v. | Other birds | | | 4 | 0 | 0 | | 0 | 0 | 0 | 4 |
| 6.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 6.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 6.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 6.z. | TOTAL | | | 175 | 5.169 | 0 | | 0 | 46.699 | 22 | 52.065 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 42.721 | 1.866 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6.869 | 51.456 |
| 7.b. | Rats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 0 | 0 | 0 | 228 | 243 |
| 7.c. | Guinea-Pigs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 59 | 59 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 0 | 0 | 84 | 84 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 0 | 0 | 98 | 98 |
| 7.h. | Dogs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |  | 0 | 0 | 105 | 105 |
| 7.i. | Ferrets |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.j. | Other Carnivores |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.l. | Pigs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 16 | 16 |
| 7.m. | Goats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.n. | Sheep |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.o. | Cattle |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.p. | Prosimians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.q. | New World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.s. | Apes |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.t. | Other Mammals |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.u. | Quail |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 |
| 7.w. | Reptiles |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.x. | Amphibians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.y. | Fish |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.z. | TOTAL | 42.721 | 1.866 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 0 | 0 | 0 | 7.463 | 52.065 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 223 | 235 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.c. | Products/substances used or intended to be used mainly in industry |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.d. | Products/substances used or intended to be used mainly in the household |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.i. | Other toxicological or safety evaluations | 1.866 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 0 | 0 | 0 | 49.949 | 51.830 |
| 8.j. | TOTAL | 1.878 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 0 | 0 | 0 | 50.172 | 52.065 |

GREECE

Statistical data submitted

The statistical data have been submitted by the “ΥΠΟΥΡΓΕΙΟ ΓΕΩΡΓΙΑΣ ΓΕΝΙΚΗ Δ/ΝΣΗ ΚΤΗΝΙΑΤΡΙΚΗΣ” (Ministry of Rural Development and Food, Directorate for Veterinary Care, Drugs & Practice).

Comments of Greek authorities

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

Presidential Decree No 160/91 (Government Gazette I 64) on the protection of animals used for experimental and other scientific purposes, in accordance with Council Directive 86/609/EEC, and

Law No 2015/92 (Government Gazette I 30) approving the European Convention on the protection of animals used for experimental and other scientific purposes.

For the collection of statistics relating to 2008 use was made of the tables, data and glossary of terms set out in European Commission document EL/11/97/04100000 W00 - 24-6-1997. The Ministry of Rural Development and Food, Directorate-General for Veterinary Affairs, Directorate for Veterinary Care, Drugs & Practice sent them directly to the educational establishments (universities and technological colleges), research centres, healthcare institutions and businesses and pharmaceutical companies which use vertebrate animals for experimental and other scientific purposes. These documents were not sent to cosmetics manufacturers for the year in question, as our department was informed that no cosmetics company uses animals for experimental purposes in Greece.

The total number of animals used in experiments in Greece in 2008 was 28021.

Of these, 86,36% (24198 animals) were rodents (19,786 mice – accounting for 81,77%, 4,367 rats - accounting for 18,05%, 45 guinea pigs - accounting for 0,18%), 32,82% of which were used to study fundamental biological characteristics, 15,2% for research and development of medical, dental and veterinary products and appliances, 0,24% to control the production and quality of medical and dental products and appliances, 31,67% for toxicological and other safety studies, 16,02% for diagnosing illnesses, 2,5% for education and training purposes and, finally, 1,52% for other purposes.

Rabbits accounted for 5,34% of the animals used: (1,498 animals, of which 31 had already been used) of which 36,18% were used to study fundamental biological characteristics, 48,86% for research and development of medical, dental and veterinary products and appliances, 3,67% to control the production and quality of veterinary products and appliances, 2,67% for toxicological studies, 2,67% for diagnosing illnesses, 5,87% for education and training purposes and 0,06% for other purposes.

Fish accounted for 4,28% of the animals used (1200 animals), and were used to study fundamental biological characteristics.

Pigs accounted for 2,26% of the animals used (624 animals) of which 14,58% were used to study fundamental biological characteristics, 47,27% for research and development of medical, dental and veterinary products and appliances, 2,24% to control the production and quality of medical and dental products and appliances, and 35,89% for education and training purposes.

Amphibians accounted for 0,71% of the animals used (200 animals) of which 100% were used for education and training purposes.

Other birds accounted for 0,31% of the animals used (88 animals), of which 57,95% were used to study fundamental biological characteristics, 34% for diagnosing illnesses, 6,81% for education and training purposes, and 1,13% for other purposes.

Bovines accounted for 0,25% of the animals used (72 animals), and were used for education and training purposes.

Sheep accounted for 0,4% of the animals used (68 animals) of which 51,47% were used for diagnosing illnesses, 47,05% for education and training purposes, and 1,47% for other purposes.

Dogs accounted for 0,18% of the animals used (44 animals) of which 88,63% were used for research and development of medical, dental and veterinary products and appliances and 11,36% for education and training purposes.

Goats accounted for 0,09% of the animals used (24 animals), of which 75% were used for diagnosing illnesses and 25% for education and training purposes

Cats accounted for 0,01% of the animals used (4 animals), and were used for research and development of medical, dental and veterinary products and appliances.

Finally, only one (1) equid was used, for education and training purposes.

It is apparent from the above data that the two main categories of experiments conducted in Greece are on the one hand, research and development of medical, dental and veterinary products and appliances and on the other, the study of fundamental biological characteristics.

It is apparent from the above data and from the tables that in 2008 the four categories of tests which used most animals were biological studies, followed by toxicological and other safety studies, research and development of medical, dental and veterinary products, and the diagnosis of illnesses. The main species used were rodents, fish, and rabbits.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 19786 | 19493 | 206 |  | 87 |  |
| 1.b. | Rats (Rattus norvegicus) | 4367 | 4332 | 20 |  | 15 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 45 | 21 |  |  | 24 |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 1498 | 1467 |  |  | 31 |  |
| 1.g. | Cats (Felis catus) | 4 | 4 |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 44 | 34 | 10 |  |  |  |
| 1.i. | Ferrets (Mustela putorius furo) | 0 |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) |  |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 1 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 624 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 24 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 68 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 72 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) | 0 |  |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 0 |  |  |  |  |  |
| 1.s. | Apes (Hominoidea) | 0 |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) |  |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 0 |  |  |  |  |  |
| 1.v. | Other birds (other Aves) | 88 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 200 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 1200 |  |  |  |  |  |
| 1.z. | TOTAL | 28021 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
  
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 6274 | 2271 |  |  | 7197 | 3574 | 172 | 298 | 19786 |
| 2.b. | Rats | 1670 | 1408 | 60 |  | 468 | 264 | 427 | 70 | 4367 |
| 2.c. | Guinea-Pigs |  |  |  |  |  | 40 | 5 |  | 45 |
| 2.d. | Hamsters |  |  |  |  |  |  |  |  | 0 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits | 542 | 732 |  | 55 | 40 | 40 | 88 | 1 | 1498 |
| 2.g. | Cats |  | 4 |  |  |  |  |  |  | 4 |
| 2.h. | Dogs |  | 39 |  |  |  |  | 5 |  | 44 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds |  |  |  |  |  |  | 1 |  | 1 |
| 2.l. | Pigs | 91 | 295 | 14 |  |  |  | 224 |  | 624 |
| 2.m. | Goats |  |  |  |  |  | 18 | 6 |  | 24 |
| 2.n. | Sheep |  |  |  |  |  | 35 | 32 | 1 | 68 |
| 2.o. | Cattle |  |  |  |  |  |  | 72 |  | 72 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals |  |  |  |  |  |  |  |  | 0 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds | 51 |  |  |  |  | 30 | 6 | 1 | 88 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  | 200 |  | 200 |
| 2.y. | Fish | 1200 |  |  |  |  |  |  |  | 1200 |
| 2.z. | TOTAL | 9828 | 4749 | 74 | 55 | 7705 | 4001 | 1238 | 371 | 28021 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 120 |  |  |  |  |  |  |  | 7077 | 7197 |
| 3.b. | Rats | 430 | 12 |  |  |  |  |  | 26 |  | 468 |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 40 |  |  |  |  |  |  |  |  | 40 |
| 3.g. | Cats |  |  |  |  |  |  |  |  |  | 0 |
| 3.h. | Dogs |  |  |  |  |  |  |  |  |  | 0 |
| 3.i. | Ferrets |  |  |  |  |  |  |  |  |  | 0 |
| 3.j. | Other Carnivores |  |  |  |  |  |  |  |  |  | 0 |
| 3.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  | 0 |
| 3.l. | Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.m. | Goats |  |  |  |  |  |  |  |  |  | 0 |
| 3.n. | Sheep |  |  |  |  |  |  |  |  |  | 0 |
| 3.o. | Cattle |  |  |  |  |  |  |  |  |  | 0 |
| 3.p. | Prosimians |  |  |  |  |  |  |  |  |  | 0 |
| 3.q. | New World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  | 0 |
| 3.s. | Apes |  |  |  |  |  |  |  |  |  | 0 |
| 3.t. | Other Mammals |  |  |  |  |  |  |  |  |  | 0 |
| 3.u. | Quail |  |  |  |  |  |  |  |  |  | 0 |
| 3.v. | Other birds |  |  |  |  |  |  |  |  |  | 0 |
| 3.w. | Reptiles |  |  |  |  |  |  |  |  |  | 0 |
| 3.x. | Amphibians |  |  |  |  |  |  |  |  |  | 0 |
| 3.y. | Fish |  |  |  |  |  |  |  |  |  | 0 |
| 3.z. | TOTAL | 590 | 12 | 0 | 0 | 0 | 0 | 0 | 26 | 7077 | 7705 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 1838 | 1756 | 1196 | 2512 | 207 | 7509 |
| 4.b. | Rats | 570 | 447 | 40 | 1138 | 11 | 2206 |
| 4.c. | Guinea-Pigs |  |  |  |  | 40 | 40 |
| 4.d. | Hamsters |  |  |  |  |  | 0 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits | 489 | 18 |  | 625 | 31 | 1163 |
| 4.g. | Cats |  |  |  |  |  | 0 |
| 4.h. | Dogs |  |  |  |  |  | 0 |
| 4.i. | Ferrets |  |  |  |  |  | 0 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds |  |  |  |  |  | 0 |
| 4.l. | Pigs | 237 |  |  | 122 |  | 359 |
| 4.m. | Goats |  |  |  |  | 18 | 18 |
| 4.n. | Sheep |  |  |  |  | 35 | 35 |
| 4.o. | Cattle |  |  |  |  |  | 0 |
| 4.p. | Prosimians |  |  |  |  |  | 0 |
| 4.q. | New World Monkeys |  |  |  |  |  | 0 |
| 4.r. | Old World Monkeys |  |  |  |  |  | 0 |
| 4.s. | Apes |  |  |  |  |  | 0 |
| 4.t. | Other Mammals |  |  |  |  |  | 0 |
| 4.u. | Quail |  |  |  |  |  | 0 |
| 4.v. | Other birds |  |  |  |  | 30 | 30 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  |  |  |  |  | 0 |
| 4.y. | Fish | 1000 | 200 |  |  |  | 1200 |
| 4.z. | TOTAL | 4134 | 2421 | 1236 | 4397 | 372 | 12560 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | |  |  |  | |  |  |  | 0 |
| 5.b. | Rats | | |  | 60 |  | |  |  |  | 60 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | |  | 55 |  | |  |  |  | 55 |
| 5.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 5.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 5.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 5.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 5.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 5.l. | Pigs | | |  | 14 |  | |  |  |  | 14 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 5.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 5.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 5.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 5.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 5.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 5.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 5.v. | Other birds | | |  |  |  | |  |  |  | 0 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 0 | 129 | 0 | | 0 | 0 | 0 | 129 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | |  | 120 |  | |  | 7077 |  | 7197 |
| 6.b. | Rats | | | 38 | 430 |  | |  |  |  | 468 |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | |  | 40 |  | |  |  |  | 40 |
| 6.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 6.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 6.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 6.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 6.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  |  | 0 |
| 6.l. | Pigs | | |  |  |  | |  |  |  | 0 |
| 6.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 6.n. | Sheep | | |  |  |  | |  |  |  | 0 |
| 6.o. | Cattle | | |  |  |  | |  |  |  | 0 |
| 6.p. | Prosimians | | |  |  |  | |  |  |  | 0 |
| 6.q. | New World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.r. | Old World Monkeys | | |  |  |  | |  |  |  | 0 |
| 6.s. | Apes | | |  |  |  | |  |  |  | 0 |
| 6.t. | Other Mammals | | |  |  |  | |  |  |  | 0 |
| 6.u. | Quail | | |  |  |  | |  |  |  | 0 |
| 6.v. | Other birds | | |  |  |  | |  |  |  | 0 |
| 6.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 6.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 6.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 6.z. | TOTAL | | | 38 | 590 | 0 | | 0 | 7077 | 0 | 7705 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  | 7077 |  |  |  |  |  |  |  |  |  |  | 120 | 7197 |
| 7.b. | Rats |  |  | 12 |  |  |  |  |  |  | 26 |  |  | 430 | 468 |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |  |  | 40 | 40 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.h. | Dogs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.i. | Ferrets |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.j. | Other Carnivores |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.l. | Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.m. | Goats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.n. | Sheep |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.o. | Cattle |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.p. | Prosimians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.q. | New World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.r. | Old World Monkeys |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.s. | Apes |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.t. | Other Mammals |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.u. | Quail |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.v. | Other birds |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.w. | Reptiles |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.x. | Amphibians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.y. | Fish |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.z. | TOTAL | 0 | 7077 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 26 | 0 | 0 | 590 | 7705 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine |  |  |  |  |  |  |  |  |  |  |  |  | 590 | 590 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  |  | 12 |  |  |  |  |  |  |  |  |  |  | 12 |
| 8.c. | Products/substances used or intended to be used mainly in industry |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.d. | Products/substances used or intended to be used mainly in the household |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns |  |  |  |  |  |  |  |  |  | 26 |  |  |  | 26 |
| 8.i. | Other toxicological or safety evaluations |  | 7077 |  |  |  |  |  |  |  |  |  |  |  | 7077 |
| 8.j. | TOTAL | 0 | 7077 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 26 | 0 | 0 | 590 | 7705 |

SPAIN

Statistical data submitted

The Statistical data have been provided by the: "Ministerio de Agricultura, Pesca y Alimentación, Subdirección General de Ordenacion de explotaciones" (Ministry of Agriculture, Fisheries and Food, Sub-directorate of Management of Developments).

Comments of Spanish authorities

The statistical information was put together by the Ministry of the Environment and the Rural and Marine Environment (MARM) on the basis of data it had collected itself or received from the individual Autonomous Communities.

220 establishments are registered for 2009. The number of establishments has remained at around the same level for the past few years.

The MARM is currently changing its system for registering holdings, suppliers and users of animals for scientific purposes so that they will be included in the REGA database (register of livestock holdings).

As regards the trend in the past few years in the number of animals used within the scope of Directive 86/609/EEC, while the total has gone down, there has been an increase in the use for research purposes of 'nontraditional' species, such as farm animals.

The tables on the use of animals and the possible regulatory requirements show an increase in the number of animals used in the production and quality control of medical, dental or veterinary products, greater pressure from EU regulation and a fall in the use of animals to meet the requirements of 'other rules'.

Finally, there has been a fall in the number of animals used for training purposes.

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

Origin versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1  Species | | 1.2  Total | 1.3  Animals coming from registered breeding or supplying establishments within the reporting country | 1.4  Animals coming from elsewhere in the EC | 1.5  Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) | 1.6  Animals coming from other origins | 1.7  Re-used animals |
| 1.a. | Mice (Mus musculus) | 543680 | 467820 | 67595 | 41 | 8224 |  |
| 1.b. | Rats (Rattus norvegicus) | 175325 | 147505 | 27397 | 0 | 423 | 275 |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 12620 | 9601 | 3019 | 0 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 1262 | 1138 | 113 | 0 | 11 |  |
| 1.e. | Other Rodents (other Rodentia) | 251 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 19626 | 18651 | 873 | 0 | 102 | 396 |
| 1.g. | Cats (Felis catus) | 100 | 73 | 0 | 0 | 27 | 0 |
| 1.h. | Dogs (Canis familiaris) | 1046 | 990 | 43 | 0 | 13 | 1 |
| 1.i. | Ferrets (Mustela putorius furo) | 287 | 14 | 0 | 0 | 273 | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 5 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 90 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 15121 |  |  |  |  | 902 |
| 1.m. | Goats (Capra) | 372 |  |  |  |  | 20 |
| 1.n. | Sheep (Ovis) | 2386 |  |  |  |  | 3 |
| 1.o. | Cattle (Bos) | 1091 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 |  |
| 1.q. | New World Monkeys (Ceboidea) | 8 | 0 | 8 | 0 | 0 |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 517 | 362 | 152 | 3 | 0 |  |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 |  |
| 1.t. | Other Mammals (other Mammalia) | 28 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 138 | 81 | 0 | 0 | 57 |  |
| 1.v. | Other birds (other Aves) | 52104 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 704 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 71098 |  |  |  |  |  |
| 1.z. | TOTAL | 897859 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 268703 | 136072 | 16012 | 19904 | 63052 | 20338 | 6665 | 12934 | 543680 |
| 2.b. | Rats | 63513 | 65305 | 2311 | 9750 | 8810 | 11256 | 8305 | 6075 | 175325 |
| 2.c. | Guinea-Pigs | 149 | 4537 | 868 | 3370 | 3566 | 102 | 28 | 0 | 12620 |
| 2.d. | Hamsters | 564 | 409 | 0 | 0 | 156 | 119 | 14 | 0 | 1262 |
| 2.e. | Other Rodents | 206 | 10 | 0 | 0 | 0 | 0 | 0 | 35 | 251 |
| 2.f. | Rabbits | 1247 | 3658 | 879 | 5318 | 6765 | 488 | 232 | 1039 | 19626 |
| 2.g. | Cats | 48 | 17 | 0 | 4 | 0 | 0 | 0 | 31 | 100 |
| 2.h. | Dogs | 65 | 389 | 0 | 176 | 349 | 6 | 44 | 17 | 1046 |
| 2.i. | Ferrets | 14 | 241 | 0 | 0 | 32 | 0 | 0 | 0 | 287 |
| 2.j. | Other Carnivores | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| 2.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 90 | 0 | 0 | 0 | 0 | 90 |
| 2.l. | Pigs | 841 | 2428 | 0 | 903 | 4925 | 329 | 2013 | 3682 | 15121 |
| 2.m. | Goats | 52 | 37 | 27 | 0 | 0 | 0 | 125 | 131 | 372 |
| 2.n. | Sheep | 186 | 1070 | 50 | 812 | 78 | 44 | 124 | 22 | 2386 |
| 2.o. | Cattle | 154 | 472 | 0 | 304 | 58 | 0 | 103 | 0 | 1091 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.q. | New World Monkeys | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 |
| 2.r. | Old World Monkeys | 16 | 74 | 0 | 0 | 427 | 0 | 0 | 0 | 517 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 0 | 0 | 0 | 16 | 0 | 12 | 0 | 0 | 28 |
| 2.u. | Quail | 57 | 57 | 0 | 0 | 24 | 0 | 0 | 0 | 138 |
| 2.v. | Other birds | 664 | 4113 | 344 | 4991 | 35297 | 30 | 42 | 6623 | 52104 |
| 2.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.x. | Amphibians | 661 | 0 | 0 | 0 | 0 | 0 | 13 | 30 | 704 |
| 2.y. | Fish | 52521 | 5780 | 0 | 0 | 940 | 400 | 152 | 11305 | 71098 |
| 2.z. | TOTAL | 389674 | 224669 | 20491 | 45638 | 124479 | 33124 | 17860 | 41924 | 897859 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 19644 | 0 | 0 | 0 | 126 | 0 | 1023 | 557 | 41702 | 63052 |
| 3.b. | Rats | 6570 | 170 | 296 | 120 | 124 | 0 | 0 | 0 | 1530 | 8810 |
| 3.c. | Guinea-Pigs | 3530 | 0 | 32 | 0 | 0 | 0 | 0 | 0 | 4 | 3566 |
| 3.d. | Hamsters | 156 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 156 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 6298 | 43 | 272 | 42 | 110 | 0 | 0 | 0 | 0 | 6765 |
| 3.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.h. | Dogs | 254 | 52 | 0 | 0 | 0 | 0 | 0 | 0 | 43 | 349 |
| 3.i. | Ferrets | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 32 |
| 3.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.l. | Pigs | 791 | 0 | 0 | 0 | 0 | 0 | 4134 | 0 | 0 | 4925 |
| 3.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.n. | Sheep | 78 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 78 |
| 3.o. | Cattle | 58 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 58 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.r. | Old World Monkeys | 427 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 427 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 0 | 24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 |
| 3.v. | Other birds | 1268 | 0 | 0 | 0 | 0 | 0 | 34029 | 0 | 0 | 35297 |
| 3.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.y. | Fish | 0 | 0 | 504 | 0 | 0 | 0 | 0 | 286 | 150 | 940 |
| 3.z. | TOTAL | 39106 | 289 | 1104 | 162 | 360 | 0 | 39186 | 843 | 43429 | 124479 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 15692 | 36425 | 85628 | 48186 | 7331 | 193262 |
| 4.b. | Rats | 11159 | 33110 | 2520 | 58447 | 586 | 105822 |
| 4.c. | Guinea-Pigs | 0 | 234 | 60 | 4687 | 298 | 5279 |
| 4.d. | Hamsters | 51 | 103 | 349 | 68 | 175 | 746 |
| 4.e. | Other Rodents | 0 | 231 | 0 | 10 | 0 | 241 |
| 4.f. | Rabbits | 6 | 6 | 0 | 1989 | 2541 | 4542 |
| 4.g. | Cats | 4 | 9 | 0 | 3 | 0 | 16 |
| 4.h. | Dogs | 47 | 0 | 45 | 88 | 94 | 274 |
| 4.i. | Ferrets | 0 | 0 | 0 | 241 | 0 | 241 |
| 4.j. | Other Carnivores | 27 | 0 | 0 | 4 | 5 | 36 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 86 | 86 |
| 4.l. | Pigs | 352 | 5 | 3 | 906 | 2592 | 3858 |
| 4.m. | Goats | 20 | 0 | 0 | 8 | 0 | 28 |
| 4.n. | Sheep | 26 | 36 | 24 | 170 | 873 | 1129 |
| 4.o. | Cattle | 0 | 0 | 0 | 0 | 606 | 606 |
| 4.p. | Prosimians | 0 | 0 | 0 | 3 | 0 | 3 |
| 4.q. | New World Monkeys | 0 | 3 | 0 | 0 | 0 | 3 |
| 4.r. | Old World Monkeys | 0 | 59 | 0 | 15 | 8 | 82 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 0 | 0 | 0 | 0 | 12 | 12 |
| 4.u. | Quail | 0 | 0 | 0 | 57 | 0 | 57 |
| 4.v. | Other birds | 0 | 0 | 0 | 20 | 7325 | 7345 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.x. | Amphibians | 0 | 5 | 130 | 382 | 0 | 517 |
| 4.y. | Fish | 200 | 500 | 485 | 23378 | 4866 | 29429 |
| 4.z. | TOTAL | 27584 | 70726 | 89244 | 138662 | 27398 | 353614 |

  

TABLE 5:
   NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 5.1  Species | | | | 5.2  National legislation specific to a single EC Member State  1) | 5.3  EC legislation including European Pharmacopoeia  (requirements) | 5.4  Member Country of Council of Europe (but not EC) legislation  2) | | 5.5  Other legislation | 5.6  Any combination of  5.2/ 5.3/ 5.4/ 5.5 | 5.7  No regulatory requirements | 5.8  Total |
| 5.a. | Mice | | | 0 | 33234 | 0 | | 403 | 0 | 2279 | 35916 |
| 5.b. | Rats | | | 0 | 11278 | 0 | | 655 | 128 | 0 | 12061 |
| 5.c. | Guinea-Pigs | | | 0 | 3344 | 0 | | 731 | 0 | 163 | 4238 |
| 5.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 0 | 5337 | 0 | | 0 | 16 | 844 | 6197 |
| 5.g. | Cats | | | 4 | 0 | 0 | | 0 | 0 | 0 | 4 |
| 5.h. | Dogs | | | 176 | 0 | 0 | | 0 | 0 | 0 | 176 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 90 | 0 | | 0 | 0 | 0 | 90 |
| 5.l. | Pigs | | | 0 | 507 | 0 | | 0 | 130 | 266 | 903 |
| 5.m. | Goats | | | 0 | 27 | 0 | | 0 | 0 | 0 | 27 |
| 5.n. | Sheep | | | 0 | 749 | 54 | | 0 | 0 | 59 | 862 |
| 5.o. | Cattle | | | 26 | 278 | 0 | | 0 | 0 | 0 | 304 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 16 | 0 | | 0 | 0 | 0 | 16 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 0 | 3496 | 0 | | 1321 | 0 | 518 | 5335 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 206 | 58356 | 54 | | 3110 | 274 | 4129 | 66129 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 1147 | 18053 | 30 | | 0 | 40120 | 3702 | 63052 |
| 6.b. | Rats | | | 290 | 2934 | 0 | | 244 | 4286 | 1056 | 8810 |
| 6.c. | Guinea-Pigs | | | 0 | 434 | 84 | | 288 | 2752 | 8 | 3566 |
| 6.d. | Hamsters | | | 80 | 76 | 0 | | 0 | 0 | 0 | 156 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 100 | 764 | 0 | | 218 | 5547 | 136 | 6765 |
| 6.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.h. | Dogs | | | 0 | 30 | 0 | | 0 | 284 | 35 | 349 |
| 6.i. | Ferrets | | | 0 | 32 | 0 | | 0 | 0 | 0 | 32 |
| 6.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.l. | Pigs | | | 0 | 329 | 0 | | 0 | 4585 | 11 | 4925 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 28 | 0 | | 0 | 44 | 6 | 78 |
| 6.o. | Cattle | | | 0 | 0 | 0 | | 0 | 58 | 0 | 58 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.r. | Old World Monkeys | | | 0 | 75 | 0 | | 0 | 352 | 0 | 427 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 24 | 0 | 0 | | 0 | 0 | 0 | 24 |
| 6.v. | Other birds | | | 0 | 1 | 0 | | 0 | 34029 | 1267 | 35297 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 504 | 150 | 0 | | 0 | 286 | 0 | 940 |
| 6.z. | TOTAL | | | 2145 | 22906 | 114 | | 750 | 92343 | 6221 | 124479 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 6991 | 39161 | 908 | 56 | 298 | 0 | 840 | 0 | 0 | 0 | 0 | 0 | 14798 | 63052 |
| 7.b. | Rats | 246 | 398 | 949 | 290 | 76 | 0 | 2593 | 0 | 0 | 0 | 437 | 0 | 3821 | 8810 |
| 7.c. | Guinea-Pigs | 0 | 303 | 24 | 0 | 326 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2913 | 3566 |
| 7.d. | Hamsters | 16 | 0 | 0 | 0 | 0 | 0 | 80 | 0 | 0 | 0 | 0 | 0 | 60 | 156 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 22 | 0 | 143 | 397 | 0 | 248 | 0 | 0 | 94 | 0 | 69 | 0 | 5792 | 6765 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.h. | Dogs | 0 | 0 | 0 | 0 | 0 | 0 | 276 | 0 | 0 | 0 | 0 | 0 | 73 | 349 |
| 7.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 32 | 32 |
| 7.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.l. | Pigs | 0 | 0 | 0 | 40 | 0 | 0 | 119 | 0 | 0 | 0 | 0 | 0 | 4766 | 4925 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 78 | 78 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 58 | 58 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 18 | 0 | 0 | 0 | 0 | 0 | 405 | 0 | 0 | 0 | 0 | 0 | 4 | 427 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 0 | 24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 24 |
| 7.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 35297 | 35297 |
| 7.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.y. | Fish | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 213 | 504 | 0 | 0 | 0 | 223 | 940 |
| 7.z. | TOTAL | 7293 | 39886 | 2024 | 783 | 700 | 248 | 4313 | 213 | 598 | 0 | 506 | 0 | 67915 | 124479 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 2082 | 2797 | 1788 | 416 | 602 | 62 | 3942 |  | 94 |  | 506 |  | 26817 | 39106 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  | 39 |  | 105 |  |  | 141 |  |  |  |  |  | 4 | 289 |
| 8.c. | Products/substances used or intended to be used mainly in industry |  | 28 | 236 | 75 | 98 | 113 | 50 |  | 504 |  |  |  |  | 1104 |
| 8.d. | Products/substances used or intended to be used mainly in the household |  |  |  | 139 |  | 23 |  |  |  |  |  |  |  | 162 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 60 | 202 |  | 48 |  | 50 |  |  |  |  |  |  |  | 360 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption |  | 1023 |  |  |  |  |  |  |  |  |  |  | 38163 | 39186 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 557 |  |  |  |  |  |  | 213 |  |  |  |  | 73 | 843 |
| 8.i. | Other toxicological or safety evaluations | 4594 | 35797 |  |  |  |  | 180 |  |  |  |  |  | 2858 | 43429 |
| 8.j. | TOTAL | 7293 | 39886 | 2024 | 783 | 700 | 248 | 4313 | 213 | 598 | 0 | 506 | 0 | 67915 | 124479 |

[Top](#document3)

EN

|  |  |
| --- | --- |
|  | EUROPEAN COMMISSION |

Brussels, 30.9.2010

SEC(2010) 1107 final

VOL B - Part III ([I], [II], [IV])

COMMISSION STAFF WORKING DOCUMENT

DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
  
  
Accompanying document to the
  
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT 
  

  
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

COM(2010) 511 final

  

Important notice

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

VOL B - Part III: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

TABLE OF CONTENTS

AUSTRIA
   5

POLAND
   19

PORTUGAL
   28

ROMANIA
   42

AUSTRIA

Statistical data submitted

The statistical data have been submitted by the “Bundesministerien für Gesundheit und Frauen- Land und Forstwirtshaft, Umwelt und Wasserwirtschaft – Wirtschaft und Arbeit - Bildung, Wissenschaft und Kultur” (Federal Ministries for Health and Women -Agriculture Forestry, the Environment and Water Mangement – Economic Affairs and Labour - Education, Science and Culture).

Comments from the Austrian authorities

The number of animals used in procedures in Austria during 2008 has risen by 11,4% as compared to 2007. However, relative to international figures the Austrian number still remains low. The animal use statistics for 2008 show that in total 220,456 animals were used in procedures in Austria.

Compared to previous years, this total number lies within the range of variation of the last years, yet is still well below the number of the earliest years. Relative to 1990 (the year statistics were recorded for the first time, in which year 482,166 animals were used in procedures) the number of animals is reduced by about 55%. No great apes were used in 2008. No animals have been used for cosmetics testing. The statistics have been presented in the EU-wide standardized format.

  

Development of the numbers of animals used since 1990

![](./../../../resource.html?uri=comnat:sec2010_1107en01_54.xhtml.61002.jpg)

Breakdown according to areas of competence

A breakdown of the numbers according to areas of competence for administration of the Animal Experiments Law ranks them as follows:

Health (BMG: Federal Ministry of Health - primarily R&D for pharmaceuticals, production and quality control of pharmaceuticals and medicinal products, animal health products) is placed first with 155,161 (70,3%) animals. Second is Science and Research (BMWF: Federal Ministry of Science and Research: universities, Austrian Academy of Sciences, etc. - primarily basic research, in particular health related research) with 58,971 (26,8%) animals. Environmental Protection and Agriculture (BMLFUW: Federal Ministry of Agriculture, Forestry, Environment and Water Management - primarily safety testing of chemicals and protection of the environment) follows with 3,872 (1,8%) animals and Industry (BMWFJ: Federal Ministry of Economy, Family and Youth - primarily basic research) is last with 2,452 (1,1%) animals used.

![](./../../../resource.html?uri=comnat:sec2010_1107en01_54.xhtml.61003.jpg)
![](./../../../resource.html?uri=comnat:sec2010_1107en01_54.xhtml.61004.jpg)

Predominantly mice and rats are used as experimental animals

Of the total number of 220,456 animals used in procedures in Austria during 2008 were:

|  |  |  |
| --- | --- | --- |
| 187.472 | 85,0% | mice and rats |
| 18.761 | 8,5% | rabbits |
| 3.284 | 1,5% | guinea pigs |
| 5.888 | 2,7% | agricultural animals |
| 1.381 | 0,6% | birds |
| 2.579 | 1,2% | fish |
| 754 | 0,3% | small animals (hamsters, ferrets, other rodents) |
| 294 | 0,1% | amphibia and reptiles |
| 41 |  | dogs |
| 2 |  | cats |

![](./../../../resource.html?uri=comnat:sec2010_1107en01_54.xhtml.61005.jpg)

  

Animal Tests for Humans and Animals

The number of animals used in procedures in 2008 - with 85% (187,472) predominantly mice and rats – is generally due to increased biomedical research in Austria as well as businesses active in biomedical, pharmaceutical and biological research and production. This research and development was directed to production and quality control of human and veterinary pharmaceuticals and medicinal products manufactured for the international market and for combating severe diseases such as cancer or cardiovascular diseases.

A significant part was also devoted to the development, production and quality control of vaccines for the international market, in particular vaccines for which there was a demand from health authorities all over the world.

In scientific and basic research the aims were inter alia improvement of the knowledge in the area of cancer research and development of effective therapies with reduced side effects or stress for the patients. Fundamental and applied research was conducted on cardiovascular diseases (myocardial infarction and its consequences) and neurological disorders (Alzheimer, Parkinson and prion-related diseases).

Increased biomedical research as well as the development of pharmaceuticals and medicinal products requires animal tests - as a first step and precondition for clinical testing on humans – in the interest of health and safety of humans and animals. The same is also true for quality control of pharmaceuticals and medicinal products.

Last but not least, animal tests are also required for animal health, meaning that for the development of veterinary pharmaceuticals it is necessary to conduct clinical studies on animal patients, and animal tests are similarly necessary for the development of diagnostic and therapeutic measures for animals.

Animal Test with Minimal Pain on Healthy Cattle for the Health of Agricultural Animals

An example of the fact that animal tests with minimal pain are sometimes necessary to improve the health of animals is provided by the number of cattle which appear in the 2008 Statistics due to a research project of the Federal Ministry of Agriculture, Forestry, Environment and Water Management dealing with “Full pastoral farming of dairy cattle under alpine production conditions”. In this research project merely blood samples were taken from healthy cows in agricultural productions units in order to investigate how the conversion to low-input pastoral farming affects fertility and animal health, milk production and quality and to find out which consequences for the output of the farm and for the environment might arise from the conversion.

No animal experiments for cosmetics

In accordance with the legal prohibition of animal experiments for cosmetics (§ 3 Abs. 5 Tierversuchsgesetz) in force since 1999 there were naturally no animal experiments carried out for cosmetics.

No great apes used

It is particularly gratifying that in 2008 in Austria no animal experiments on great apes were carried out, in accordance with the legal prohibition of animal experiments on great apes which has been in force since January 1, 2006 (BGBl. I, Nr. 162/2005). This also reflects a general trend in Europe to restrict such experiments as far as possible and to avoid them altogether according to the best available science.

Statistics in EU-wide standardized format

In accordance with the amended Animal Experiments Law (BGBl. I, Nr. 169/1999) and the Ordinance on Animal Use Statistics (BGBl. II Nr. 199/2000) the Animal Use Statistics 2008 requires the use of eight statistical tables which should contain data in a standardized format and give details on, inter alia, the origin of the animals, the purposes for which they were used (basic research, R&D for medicines and medicinal products, for quality control, etc.).

Internationally Compared Low Animal Numbers in Austria

The number of animals used in procedures in Austria contributed less than 1,5% to the total number of 12.1 million vertebrate animals used in Europe, as can be seen from the EU-wide animal use statistics for 2005 (the last year for which the European Commission compiled such a statistical report). When comparing at an international level, the figures of animal numbers in Austrian still remain low. These comparatively low numbers of animals are due to at least three interconnected developments in relation to animals experiments:

1. Application of „3R“

Firstly, scientists, researchers and users themselves apply the principles of the „3R“(Replacement, Reduction, Refinement) - which also guide the Austrian Animal Experiments Law - to the widest possible extent, as well as using alternatives.

2. Restrictive authorization practice for projects

Second, all authorities issue permits for projects very restrictively in accordance with the strict provisions of the Animal Experiments Law and the Ordinance on Animal Experiments, which allow animal experiments only under very restrictive conditions and stipulate that projects may only be permitted, if no other satisfactory methods are available to achieve the aim without using live animals.

3. Support for research on Alternative Methods to Animal Testing

Finally, public financial support for developing and promoting alternative methods contributes to motivation of users and researches:

3.1. Financial support for research projects aimed at developing alternative methods, totalling more than 2,562m EUR for 29 projects, as well as promoting the use of alternative methods nationally and internationally,

3.2. National Award for Alternative Methods, i.e. a specific award publicly recognizing scientific achievements in the area of alternative methods.

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) | 177544 | 41.468 | 133.479 | 116 | 2.481 | 61 |
| 1.b. | Rats (Rattus norvegicus) | 9928 | 4.140 | 5.652 | 0 | 136 | 20 |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 3284 | 737 | 2.547 | 0 | 0 | 0 |
| 1.d. | Hamsters (Mesocricetus ) | 693 | 0 | 693 | 0 | 0 | 0 |
| 1.e. | Other Rodents (other Rodentia) | 47 | 0 | 20 | 0 | 27 | 0 |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 18761 | 14.886 | 3.857 | 0 | 18 | 0 |
| 1.g. | Cats (Felis catus) | 2 | 0 | 2 | 0 | 0 | 0 |
| 1.h. | Dogs (Canis familiaris) | 41 | 6 | 13 | 0 | 22 | 22 |
| 1.i. | Ferrets (Mustela putorius furo) | 14 | 0 | 0 | 0 | 14 | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 47 | 16 | 20 | 0 | 11 | 20 |
| 1.l. | Pigs (Sus) | 5086 | 4889 | 6 | 0 | 191 | 0 |
| 1.m. | Goats (Capra) | 39 | 35 | 0 | 0 | 4 | 0 |
| 1.n. | Sheep (Ovis) | 142 | 98 | 0 | 0 | 44 | 23 |
| 1.o. | Cattle (Bos) | 574 | 539 | 14 | 0 | 21 | 4 |
| 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) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.u. | Quail (Coturnix coturnix) | 14 | 14 | 0 | 0 | 0 | 0 |
| 1.v. | Other birds (other Aves) | 1367 | 548 | 119 | 0 | 700 | 77 |
| 1.w. | Reptiles (Reptilia) | 17 | 0 | 0 | 0 | 17 | 0 |
| 1.x. | Amphibians (Amphibia) | 277 | 19 | 0 | 0 | 258 | 20 |
| 1.y. | Fish (Pisces) | 2579 | 1880 | 65 | 0 | 634 | 0 |
| 1.z. | TOTAL | 220456 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 44.234 | 76.102 | 51.086 | 0 | 3.420 | 1.083 | 713 | 906 | 177544 |
| 2.b. | Rats | 4.106 | 3.036 | 68 | 0 | 2.352 | 0 | 366 | 0 | 9928 |
| 2.c. | Guinea-Pigs | 211 | 522 | 1.618 | 0 | 925 | 0 | 8 | 0 | 3284 |
| 2.d. | Hamsters | 0 | 185 | 358 | 0 | 150 | 0 | 0 | 0 | 693 |
| 2.e. | Other Rodents | 47 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 47 |
| 2.f. | Rabbits | 143 | 520 | 17.276 | 14 | 726 | 0 | 82 | 0 | 18761 |
| 2.g. | Cats | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| 2.h. | Dogs | 0 | 14 | 0 | 0 | 0 | 0 | 12 | 15 | 41 |
| 2.i. | Ferrets | 0 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 14 |
| 2.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.k. | Horses, donkeys and cross breds | 35 | 0 | 0 | 0 | 0 | 12 | 0 | 0 | 47 |
| 2.l. | Pigs | 1.730 | 2.665 | 0 | 0 | 63 | 125 | 382 | 121 | 5086 |
| 2.m. | Goats | 0 | 1 | 3 | 0 | 0 | 0 | 35 | 0 | 39 |
| 2.n. | Sheep | 46 | 17 | 5 | 0 | 0 | 0 | 74 | 0 | 142 |
| 2.o. | Cattle | 334 | 14 | 0 | 0 | 0 | 5 | 176 | 45 | 574 |
| 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.u. | Quail | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 14 |
| 2.v. | Other birds | 1.174 | 84 | 14 | 0 | 0 | 12 | 83 | 0 | 1367 |
| 2.w. | Reptiles | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 17 |
| 2.x. | Amphibians | 277 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 277 |
| 2.y. | Fish | 2.053 | 0 | 0 | 0 | 416 | 60 | 0 | 50 | 2579 |
| 2.z. | TOTAL | 54423 | 83174 | 70428 | 14 | 8052 | 1297 | 1931 | 1137 | 220456 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contaminants in the general environment which do not appear in other columns | 3.10  Other toxicological or safety evaluations | 3.11  Total |
| 3.a. | Mice | 2.720 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 700 | 3420 |
| 3.b. | Rats | 824 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.528 | 2352 |
| 3.c. | Guinea-Pigs | 250 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 675 | 925 |
| 3.d. | Hamsters | 150 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 150 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.f. | Rabbits | 580 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 146 | 726 |
| 3.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.h. | Dogs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 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 | 63 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 63 |
| 3.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.y. | Fish | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 132 | 284 | 416 |
| 3.z. | TOTAL | 4587 | 0 | 0 | 0 | 0 | 0 | 0 | 132 | 3333 | 8052 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 3.871 | 4.726 | 21.735 | 48.038 | 103 | 78473 |
| 4.b. | Rats | 893 | 598 | 1.683 | 3.482 | 27 | 6683 |
| 4.c. | Guinea-Pigs | 108 | 92 | 0 | 546 | 0 | 746 |
| 4.d. | Hamsters | 0 | 358 | 0 | 185 | 0 | 543 |
| 4.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.f. | Rabbits | 94 | 14 | 2 | 841 | 0 | 951 |
| 4.g. | Cats | 0 | 0 | 0 | 0 | 2 | 2 |
| 4.h. | Dogs | 0 | 0 | 0 | 0 | 35 | 35 |
| 4.i. | Ferrets | 0 | 0 | 0 | 14 | 0 | 14 |
| 4.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 24 | 24 |
| 4.l. | Pigs | 275 | 10 | 0 | 200 | 154 | 639 |
| 4.m. | Goats | 0 | 0 | 0 | 1 | 0 | 1 |
| 4.n. | Sheep | 9 | 0 | 0 | 38 | 4 | 51 |
| 4.o. | Cattle | 0 | 0 | 0 | 0 | 344 | 344 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.v. | Other birds | 0 | 0 | 0 | 149 | 541 | 690 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.x. | Amphibians | 7 | 6 | 6 | 0 | 0 | 19 |
| 4.y. | Fish | 1.794 | 0 | 0 | 0 | 60 | 1854 |
| 4.z. | TOTAL | 7051 | 5804 | 23426 | 53494 | 1294 | 91069 |

  

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 | 7.019 | 0 | | 0 | 44.067 | 0 | 51086 |
| 5.b. | Rats | | | 60 | 8 | 0 | | 0 | 0 | 0 | 68 |
| 5.c. | Guinea-Pigs | | | 0 | 236 | 0 | | 0 | 1.382 | 0 | 1618 |
| 5.d. | Hamsters | | | 0 | 0 | 0 | | 358 | 0 | 0 | 358 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 26 | 11.078 | 0 | | 0 | 6.172 | 14 | 17290 |
| 5.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.h. | Dogs | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.l. | Pigs | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.m. | Goats | | | 0 | 0 | 0 | | 3 | 0 | 0 | 3 |
| 5.n. | Sheep | | | 0 | 0 | 0 | | 5 | 0 | 0 | 5 |
| 5.o. | Cattle | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 4 | 0 | 0 | | 10 | 0 | 0 | 14 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 90 | 18.341 | 0 | | 376 | 51.621 | 14 | 70442 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 0 | 2596 | 0 | | 0 | 824 | 0 | 3420 |
| 6.b. | Rats | | | 0 | 212 | 0 | | 0 | 2045 | 95 | 2352 |
| 6.c. | Guinea-Pigs | | | 0 | 104 | 0 | | 0 | 821 | 0 | 925 |
| 6.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 150 | 0 | 150 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.f. | Rabbits | | | 20 | 271 | 0 | | 0 | 435 | 0 | 726 |
| 6.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.h. | Dogs | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.l. | Pigs | | | 0 | 0 | 0 | | 0 | 0 | 63 | 63 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.o. | Cattle | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 132 | 0 | 0 | | 0 | 284 | 0 | 416 |
| 6.z. | TOTAL | | | 152 | 3183 | 0 | | 0 | 4559 | 158 | 8052 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 0 | 36 | 1670 | 0 | 522 | 0 | 0 | 0 | 0 | 266 | 0 | 0 | 926 | 3420 |
| 7.b. | Rats | 0 | 1124 | 136 | 12 | 0 | 0 | 629 | 0 | 0 | 0 | 0 | 0 | 451 | 2352 |
| 7.c. | Guinea-Pigs | 0 | 0 | 80 | 0 | 695 | 0 | 126 | 0 | 0 | 0 | 0 | 0 | 24 | 925 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 150 | 0 | 0 | 0 | 0 | 0 | 0 | 150 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.f. | Rabbits | 0 | 20 | 18 | 74 | 0 | 89 | 75 | 0 | 0 | 0 | 0 | 0 | 450 | 726 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.h. | Dogs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 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 | 63 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 63 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.y. | Fish | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 416 | 0 | 416 |
| 7.z. | TOTAL | 0 | 1180 | 1904 | 149 | 1217 | 89 | 980 | 0 | 0 | 266 | 0 | 416 | 1851 | 8052 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 224 | 1.904 | 63 | 20 | 17 | 420 | 0 | 0 | 88 | 0 | 0 | 1.851 | 4587 | 224 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.i. | Other toxicological or safety evaluations | 0 | 956 | 0 | 86 | 1.197 | 72 | 560 | 0 | 0 | 178 | 0 | 284 | 0 | 3333 |
| 8.j. | TOTAL | 0 | 1180 | 1904 | 149 | 1217 | 89 | 980 | 0 | 0 | 266 | 0 | 416 | 1851 | 8052 |

POLAND

Statistical data submitted

The statistical data have been submitted by the Ministry of Science and Higher Education Warsaw.

Comments of the Polish authorities

None

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) | 123897 | 122068 | 705 | 227 | 897 |  |
| 1.b. | Rats (Rattus norvegicus) | 45824 | 44646 | 61 | 150 | 967 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 6495 | 6495 | 0 | 0 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 312 | 280 | 0 | 0 | 32 |  |
| 1.e. | Other Rodents (other Rodentia) | 11966 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 3086 | 2804 | 0 | 0 | 282 | 137 |
| 1.g. | Cats (Felis catus) | 83 | 21 | 0 | 0 | 62 | 0 |
| 1.h. | Dogs (Canis familiaris) | 230 | 9 | 0 | 0 | 221 | 18 |
| 1.i. | Ferrets (Mustela putorius furo) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 520 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 529 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 11742 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 300 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 2217 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 7540 |  |  |  |  |  |
| 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) | 1246 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 5100 | 5100 | 0 | 0 | 0 |  |
| 1.v. | Other birds (other Aves) | 27391 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 248 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 1221 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 25941 |  |  |  |  |  |
| 1.z. | TOTAL | 275888 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 61614 | 2649 | 12230 | 4911 | 7243 | 2855 | 1620 | 30775 | 123897 |
| 2.b. | Rats | 33700 | 1277 | 1703 | 0 | 4845 | 2519 | 891 | 889 | 45824 |
| 2.c. | Guinea-Pigs | 26 | 0 | 5309 | 323 | 815 | 0 | 9 | 13 | 6495 |
| 2.d. | Hamsters | 186 | 100 | 0 | 0 | 0 | 10 | 6 | 10 | 312 |
| 2.e. | Other Rodents | 11526 | 0 | 0 | 0 | 204 | 50 | 106 | 80 | 11966 |
| 2.f. | Rabbits | 718 | 167 | 853 | 587 | 358 | 65 | 171 | 167 | 3086 |
| 2.g. | Cats | 0 | 0 | 13 | 0 | 1 | 9 | 0 | 60 | 83 |
| 2.h. | Dogs | 25 | 0 | 0 | 0 | 0 | 180 | 0 | 25 | 230 |
| 2.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.j. | Other Carnivores | 510 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 520 |
| 2.k. | Horses, donkeys and cross breds | 309 | 0 | 0 | 0 | 0 | 130 | 65 | 25 | 529 |
| 2.l. | Pigs | 3118 | 16 | 10 | 0 | 20 | 40 | 107 | 8431 | 11742 |
| 2.m. | Goats | 147 | 0 | 48 | 0 | 0 | 0 | 33 | 72 | 300 |
| 2.n. | Sheep | 1374 | 0 | 0 | 0 | 0 | 0 | 244 | 599 | 2217 |
| 2.o. | Cattle | 6380 | 0 | 60 | 0 | 0 | 0 | 1070 | 30 | 7540 |
| 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 | 1238 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 1246 |
| 2.u. | Quail | 4730 | 0 | 0 | 0 | 360 | 0 | 10 | 0 | 5100 |
| 2.v. | Other birds | 21006 | 88 | 524 | 0 | 97 | 222 | 650 | 4804 | 27391 |
| 2.w. | Reptiles | 246 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 248 |
| 2.x. | Amphibians | 697 | 0 | 0 | 0 | 0 | 0 | 524 | 0 | 1221 |
| 2.y. | Fish | 11022 | 0 | 0 | 0 | 3748 | 168 | 33 | 10970 | 25941 |
| 2.z. | TOTAL | 158572 | 4297 | 20750 | 5821 | 17691 | 6248 | 5549 | 56960 | 275888 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami-nants in the general envi-ronment which do not appear in other columns | 3.10  Other toxico-logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 2571 | 347 | 0 | 0 | 0 | 0 | 0 | 0 | 4325 | 7243 |
| 3.b. | Rats | 1397 | 472 | 230 | 0 | 0 | 920 | 0 | 897 | 929 | 4845 |
| 3.c. | Guinea-Pigs | 489 | 280 | 46 | 0 | 0 | 0 | 0 | 0 | 0 | 815 |
| 3.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 204 | 0 | 204 |
| 3.f. | Rabbits | 177 | 129 | 44 | 8 | 0 | 0 | 0 | 0 | 0 | 358 |
| 3.g. | Cats | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| 3.h. | Dogs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 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 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 |
| 3.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.u. | Quail | 60 | 300 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 360 |
| 3.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 97 | 0 | 97 |
| 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 | 1127 | 2260 | 169 | 52 | 0 | 0 | 0 | 140 | 0 | 3748 |
| 3.z. | TOTAL | 5822 | 3808 | 489 | 60 | 0 | 920 | 0 | 1338 | 5254 | 17691 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 1041 | 44644 | 7545 | 7020 | 1703 | 61953 |
| 4.b. | Rats | 1985 | 7400 | 493 | 7393 | 30 | 17301 |
| 4.c. | Guinea-Pigs | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.d. | Hamsters | 0 | 0 | 176 | 40 | 0 | 216 |
| 4.e. | Other Rodents | 154 | 440 | 0 | 50 | 70 | 714 |
| 4.f. | Rabbits | 0 | 0 | 0 | 455 | 0 | 455 |
| 4.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.h. | Dogs | 0 | 0 | 9 | 0 | 180 | 189 |
| 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 | 130 | 130 |
| 4.l. | Pigs | 40 | 0 | 0 | 87 | 0 | 127 |
| 4.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.n. | Sheep | 0 | 0 | 0 | 24 | 0 | 24 |
| 4.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.v. | Other birds | 0 | 1800 | 0 | 12 | 292 | 2104 |
| 4.w. | Reptiles | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.x. | Amphibians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.y. | Fish | 0 | 0 | 0 | 0 | 260 | 260 |
| 4.z. | TOTAL | 3220 | 54284 | 8223 | 15081 | 2665 | 83473 |

  

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 | | | 7974 | 5575 | 0 | | 590 | 257 | 2745 | 17141 |
| 5.b. | Rats | | | 549 | 1062 | 0 | | 60 | 32 | 0 | 1703 |
| 5.c. | Guinea-Pigs | | | 745 | 4658 | 0 | | 195 | 0 | 34 | 5632 |
| 5.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.f. | Rabbits | | | 305 | 348 | 0 | | 0 | 647 | 140 | 1440 |
| 5.g. | Cats | | | 12 | 1 | 0 | | 0 | 0 | 0 | 13 |
| 5.h. | Dogs | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.j. | Other Carnivores | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.l. | Pigs | | | 0 | 0 | 0 | | 0 | 10 | 0 | 10 |
| 5.m. | Goats | | | 48 | 0 | 0 | | 0 | 0 | 0 | 48 |
| 5.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.o. | Cattle | | | 60 | 0 | 0 | | 0 | 0 | 0 | 60 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.v. | Other birds | | | 524 | 0 | 0 | | 0 | 0 | 0 | 524 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.z. | TOTAL | | | 10217 | 11644 | 0 | | 845 | 946 | 2919 | 26571 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 2445 | 3920 | 0 | | 0 | 0 | 878 | 7243 |
| 6.b. | Rats | | | 2135 | 2462 | 0 | | 0 | 70 | 178 | 4845 |
| 6.c. | Guinea-Pigs | | | 66 | 749 | 0 | | 0 | 0 | 0 | 815 |
| 6.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.e. | Other Rodents | | | 204 | 0 | 0 | | 0 | 0 | 0 | 204 |
| 6.f. | Rabbits | | | 30 | 298 | 0 | | 0 | 0 | 30 | 358 |
| 6.g. | Cats | | | 0 | 1 | 0 | | 0 | 0 | 0 | 1 |
| 6.h. | Dogs | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 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 | 0 | 0 | | 0 | 0 | 0 | 20 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.n. | Sheep | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.o. | Cattle | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 360 | 0 | | 0 | 0 | 0 | 360 |
| 6.v. | Other birds | | | 0 | 0 | 0 | | 0 | 0 | 97 | 97 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 100 | 2598 | 0 | | 0 | 0 | 1050 | 3748 |
| 6.z. | TOTAL | | | 5000 | 10388 | 0 | | 0 | 70 | 2233 | 17691 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcinogenicity | 7.8  Develop- mental toxicity | 7.9  Muta-genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 280 | 0 | 664 | 0 | 0 | 0 | 384 | 0 | 0 | 0 | 0 | 0 | 5915 | 7243 |
| 7.b. | Rats | 584 | 0 | 881 | 0 | 0 | 0 | 859 | 0 | 1692 | 0 | 545 | 0 | 284 | 4845 |
| 7.c. | Guinea-Pigs | 0 | 0 | 0 | 0 | 546 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 269 | 815 |
| 7.d. | Hamsters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.e. | Other Rodents | 0 | 0 | 0 | 0 | 0 | 0 | 204 | 0 | 0 | 0 | 0 | 0 | 0 | 204 |
| 7.f. | Rabbits | 0 | 0 | 15 | 182 | 0 | 86 | 0 | 0 | 25 | 0 | 0 | 0 | 50 | 358 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| 7.h. | Dogs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.l. | Pigs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 20 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.n. | Sheep | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.o. | Cattle | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.r. | Old World Monkeys | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.t. | Other Mammals | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.u. | Quail | 360 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 360 |
| 7.v. | Other birds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 97 | 97 |
| 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 | 3326 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 232 | 90 | 3748 |
| 7.z. | TOTAL | 4550 | 0 | 1560 | 182 | 546 | 86 | 1447 | 0 | 1717 | 0 | 645 | 232 | 6726 | 17691 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcinogenicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 1307 | 0 | 1078 | 53 | 274 | 6 | 381 | 0 | 447 | 0 | 391 | 367 | 1518 | 5822 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 2670 | 0 | 0 | 62 | 251 | 56 | 241 | 0 | 146 | 0 | 283 | 0 | 99 | 3808 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 139 | 0 | 47 | 18 | 16 | 10 | 101 | 0 | 34 | 0 | 88 | 0 | 36 | 489 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 52 | 0 | 0 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 60 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 0 | 0 | 0 | 0 | 0 | 0 | 106 | 0 | 814 | 0 | 0 | 0 | 0 | 920 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 0 | 381 | 0 | 0 | 0 | 0 | 860 | 0 | 0 | 0 | 0 | 0 | 97 | 1338 |
| 8.i. | Other toxicological or safety evaluations | 577 | 0 | 743 | 84 | 0 | 0 | 556 | 0 | 0 | 187 | 0 | 0 | 3107 | 5254 |
| 8.j. | TOTAL | 4745 | 381 | 1868 | 221 | 541 | 76 | 2245 | 0 | 1441 | 187 | 762 | 367 | 4857 | 17691 |

PORTUGAL

Statistical data submitted

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

Comments of the Portuguese authorities

1. Total number of animals used by species

In 2008, the total number of animals used for experimental and other scientific purposes in Portugal was 50,888.

Compared to the data of 2005, where the total number of used animals was 41,621, it means that with regard to 2008 there was an increase in the use of animals of 22,26%.

Mice are the most commonly used species representing 78,23% of the total number of animals.

The second most used group of animals was Rats (12,91%).

The third most used group is represented by the Cold-blooded animals (7,47%) and the fourth by the group of Artio and Perissodactyla with 0,52%.

Rodents with Rabbits represent 91,69% of the total number of animals used.

The Carnivors were not used in 2008 and, as in other previous reports, in Portugal, Non-human primates continued to not being used.

Comparison with the data of the previous report (data of 2005)

The percentages of classes of animals used in 2005 (41,621 animals) and in 2008 (50,888 animals) are represented in the following table:

|  |  |  |
| --- | --- | --- |
| Class of animals (%) | 2005 | 2008 |
| Mice | 68,04 | 78,23 |
| Rats | 16,32 | 12,91 |
| Guinea-pigs | 0,91 | 0,30 |
| Hamsters and other rodents | 0,31 | 0,06 |
| Rabbits | 1,43 | 0,19 |
| Cold-blooded animals | 11,53 | 7,47 |
| Quail and other birds | 0,27 | 0,31 |
| Artio Perissodactyla | 1,11 | 0,52 |
| Carnivors | 0,09 | 0,00 |

In 2008, looking at the data by groups of animals, the percentage of all of them decreased. However the largest increase occurred, again, in mice and a slight increase in the Birds group (quail and other birds). The biggest decrease occurred in the use of cold-blooded animals (4,06%) followed in descending order, by the use of rats (3.41%) and in rabbits (1,24%).

Within the group of cold-blooded animals, fish were the only animals used.

Within the Artiodactyla, Pigs were the most used animals (61,67%).

2. Number of animals used by purposes of experiments

In 2008, the percentage of animals (total 50,888) used by purposes of experiments was the following:

83,82% of animals were used in “Fundamental biology”;

9,74% in “Research and development for human medicine, veterinary medicine, dentistry”;

0% in “Production and quality control of products and devices in human medicine and dentistry and veterinary medicine”;

0,61% in “Toxicological and other safety evaluation”;

1,44% in “Diagnosis of disease”;

1,83% in “Education and training”;

2,55% in “Other purposes”;

Referring to the use of species versus experimental purposes, the highest amount of use of mice and of rats is in “fundamental biology” and in “research and development for human medicine, veterinary medicine, dentistry”.

Comparison with the data of the previous report (data of 2005)

The most significant increase in 2008 is the number of animals that were used for “Fundamental biology”, which increased from 78,78%, in 2005, to 83,82%, in 2008.

The other increases that occurred were in the percentage of animals used in “Research and development for human medicine, veterinary medicine, dentistry” which increased from 6,78%, in 2005, to 9,74%, in 2008, and in “Other purposes” which increased from 1,39% in 2005, to 2,55% in 2008.

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

The percentage of animals used for “Production and quality control of products and devices in human medicine and dentistry and veterinary medicine” was the biggest decrease in 2008 as no animal was used for this purpose, compared to 2005 in which 5,09% of all animals were used to this same purpose.

The percentage of animals used for “Toxicological and other safety evaluation” decreased from 2,26% to 0,61%.

The percentage of animals used for “Education and training” decreased from 3,02% to 0,61%.

3. Number of animals used for “Toxicological and safety evaluation” by type of products

In 2008, the use of animals in “Toxicological and other safety evaluation” represents only 0,61%, which only refers to 310 animals (mice), of a total of 50,888 animals that were used for experimental purposes in Portugal.

“Potential or actual contaminants in the general environment which do not appear in other columns” represents 61,30% of the animals used for “Toxicological and other safety evaluation” and “Other toxicological or safety evaluations” represent 38,70%.

Comparison with the data of the previous report (data of 2005)

Compared to the data of 2005, in 2008 there was a decrease in the use of animals in “Toxicological and other safety evaluation”.

The percentage of animals used for “Toxicological and other safety evaluation” decreased from 2,26% to 0,61% (from 939 to 310 animals).

The data of 2008 refers to the same category of products that had been tested in 2005, except for the category of “Products/substances or devices for human medicine and dentistry and for veterinary medicine” where no animals were used in 2008.

“Potential or actual contaminants in the general environment which do not appear in other columns” represented, in 2005, 21,29% of the animals used for “Toxicological and other safety evaluation” and, in 2008, 61,30%; “Other toxicological or safety evaluations” represented 26,62% in 2005 while, in 2008, 38,70%, which means that there was an increase in 2008.

As in 2005, in 2008 the other groups of products/substances were not tested which means that, for example, there were no animals used for the purpose of evaluating the safety of cosmetics or additives in food for animal consumption.

4. Number of animals used for the study of diseases

In 2008, the number of animals used for the “Studies on human and animal diseases” was 14,753, which represents 29% of the total number of animals (50,888 animals) that were used.

The percentages of animals per type of diseases were:

2,70% in “Human cardiovascular diseases”;

15,66% in “Human nervous and mental disorders”;

2,22% in “Human cancer (excl. evaluation of carcino hazards)”;

75,57% in “Other human diseases”;

3,85% in “Specific animal diseases”.

The percentage of the number of animals used for studies of human diseases represents 96,15% (14,185 animals) of the total number of animals used for all studies of diseases (14,753 animals).

In 2008, the number of animals used to study animal diseases was only 568 (3.85%) while in 2005, that number had been 271 (1.40%), which means that in 2008, there was an increase on the use of animals for the study of animal diseases.

5. Number of animals used for “Toxicological and other safety evaluations” by the types of tests

As referred previously, in 2008, the use of animals in “Toxicological and other safety evaluation” represents only 0,61%, which only refers to 310 animals, of a total of 50,888 animals that were used for experimental purposes in Portugal.

Comparison with the data of the previous report (data of 2005)

The percentages of animals used in toxicity tests for “Toxicological and other safety evaluation” in 2005 (939 animals) and in 2008 (310 animals) are represented in the following table:

|  |  |  |
| --- | --- | --- |
| Type of tests  (%) | 2005 | 2008 |
| Acute and sub-acute toxicity testing methods (including limit test) | 37,6 | 0 |
| Irritation/sensitization tests | 27,8 | 0 |
| Sub-chronic and chronic toxicity | 0 | 0 |
| Mutagenicity and Carcinogenicity | 32 | 38,71 |
| Reproductive and developmental toxicity | 0 | 0 |
| Toxicity of aquatic vertebrates not included in other columns | 0 | 0 |
| Other tests | 2,7 | 61,29 |

In 2008, the uses of animals in toxicity tests only fell into the categories of “Carcinogenicity” and “Other tests” which means that there was a decrease in the other uses of tests compared to data of 2005, i.e., “Acute and sub-acute toxicity testing methods (including the 'limit test')” and “Irritation/sensitization tests” the percentage of which decreased to 0%.

6. Type of toxicity tests carried out for “Toxicological and other safety evaluations” of products

As pointed out previously, in 2008, the use of animals in “Toxicological and other safety evaluation” represents only 0,61%, which only refers to 310 animals, of a total of 50,888 animals that were used for experimental purposes in Portugal.

Comparison with the data of the previous report (data of 2005)

The numbers of animals used for “Toxicological and other safety evaluation” per types of products in 2005 (939 animals) and in 2008 (310 animals) are represented in the following tables:

|  |  |  |
| --- | --- | --- |
| Types of products  (%) | 2005 | 2008 |
| Products/substances or devices for human medicine and dentistry and for veterinary medicine | 689 | 120 |
| Potential or actual contaminants in the general environment which do not appear in othe columns | 0 | 190 |
| Other toxicological or safety evaluations | 250 | 0 |

In 2008, the number of animals used to test “Products/substances or devices for human medicine and dentistry and for veterinary medicine” were 120 animals in “Carcinogenicity” (in 2005, they were 200 animals);

In 2008, in comparision to 2005, there was an increase of the number of animals used to test “Potential or actual contaminants in the general environment which do not appear in other columns” from zero animals, in 2005, to 190, in 2008.

In 2008, there were no animals used to fill the category “Other toxicological or safety evaluations” which represent a decrease compared to 2005.

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) | 39811 | 29109 | 9094 |  | 1608 | 60 |
| 1.b. | Rats (Rattus norvegicus) | 6571 | 1463 | 4819 |  | 289 | 24 |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 152 | 137 | 15 |  |  | 8 |
| 1.d. | Hamsters (Mesocricetus ) | 29 | 27 | 2 |  |  |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 99 | 94 | 5 |  |  |  |
| 1.g. | Cats (Felis catus) |  |  |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) |  |  |  |  |  | 10 |
| 1.i. | Ferrets (Mustela putorius furo) |  |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) |  |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 6 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 222 |  |  |  |  |  |
| 1.m. | Goats (Capra) |  |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 28 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 10 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) |  |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) |  |  |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) |  |  |  |  |  |  |
| 1.s. | Apes (Hominoidea) |  |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) |  |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) |  |  |  |  |  |  |
| 1.v. | Other birds (other Aves) | 160 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) |  |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 3800 |  |  |  |  |  |
| 1.z. | TOTAL | 50888 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 33487 | 4272 |  |  | 310 | 646 | 196 | 900 | 39811 |
| 2.b. | Rats | 5255 | 665 |  |  |  | 89 | 492 | 70 | 6571 |
| 2.c. | Guinea-Pigs |  | 15 |  |  |  |  | 8 | 129 | 152 |
| 2.d. | Hamsters | 20 |  |  |  |  |  |  | 9 | 29 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits | 69 | 3 |  |  |  |  | 15 | 12 | 99 |
| 2.g. | Cats |  |  |  |  |  |  |  |  |  |
| 2.h. | Dogs |  |  |  |  |  |  |  |  |  |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  |  |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  |  |
| 2.k. | Horses, donkeys and cross breds |  |  |  |  |  |  | 6 |  | 6 |
| 2.l. | Pigs | 4 |  |  |  |  |  | 198 | 20 | 222 |
| 2.m. | Goats |  |  |  |  |  |  |  |  |  |
| 2.n. | Sheep | 20 |  |  |  |  |  | 8 |  | 28 |
| 2.o. | Cattle |  |  |  |  |  |  | 10 |  | 10 |
| 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 |  |  |  |  |  |  |  | 160 | 160 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  |  |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  |  |
| 2.y. | Fish | 3800 |  |  |  |  |  |  |  | 3800 |
| 2.z. | TOTAL | 42655 | 4955 | 0 | 0 | 310 | 735 | 933 | 1300 | 50888 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nants in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice |  |  |  |  |  |  |  | 190 | 120 | 310 |
| 3.b. | Rats |  |  |  |  |  |  |  |  |  |  |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |
| 3.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |
| 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 |  |  |  |  |  |  |  |  |  |  |
| 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 |  |  |  |  |  |  |  | 190 | 120 | 310 |

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 31 | 1443 | 262 | 10022 | 568 | 12326 |
| 4.b. | Rats | 327 | 868 | 65 | 928 |  | 2188 |
| 4.c. | Guinea-Pigs |  |  |  | 129 |  | 129 |
| 4.d. | Hamsters |  |  |  | 27 |  | 27 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits | 40 |  |  | 41 |  | 81 |
| 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.m. | Goats |  |  |  |  |  |  |
| 4.n. | Sheep |  |  |  |  |  |  |
| 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 | 398 | 2311 | 327 | 11149 | 568 | 14753 |

  

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 | | |  |  |  | |  |  |  |  |
| 5.b. | Rats | | |  |  |  | |  |  |  |  |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  |  |  |
| 5.d. | Hamsters | | |  |  |  | |  |  |  |  |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  |  |
| 5.f. | Rabbits | | |  |  |  | |  |  |  |  |
| 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 | | |  |  |  | |  |  |  |  |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | |  | 190 |  | |  | 120 |  | 310 |
| 6.b. | Rats | | |  |  |  | |  |  |  |  |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  |  |  |
| 6.d. | Hamsters | | |  |  |  | |  |  |  |  |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  |  |
| 6.f. | Rabbits | | |  |  |  | |  |  |  |  |
| 6.g. | Cats | | |  |  |  | |  |  |  |  |
| 6.h. | Dogs | | |  |  |  | |  |  |  |  |
| 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 | | |  | 190 |  | |  | 120 |  | 310 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  |  |  |  |  |  |  | 120 |  |  |  |  | 190 | 310 |
| 7.b. | Rats |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 7.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 7.h. | Dogs |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 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 |  |  |  |  |  |  |  | 120 |  |  |  |  | 190 | 310 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine |  |  |  |  |  |  |  | 120 |  |  |  |  |  | 120 |
| 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 |  |  |  |  |  |  |  |  |  |  |  |  | 190 | 190 |
| 8.i. | Other toxicological or safety evaluations |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| 8.j. | TOTAL |  |  |  |  |  |  |  | 120 |  |  |  |  | 190 | 310 |

ROMANIA

Statistical data submitted

International Relations and Community Programme Directorate, National Sanitary Veterinary and Food Safety Authority

Comments of Romania authorities

None

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) | 44585 | 44349 |  |  | 236 | 1483 |
| 1.b. | Rats (Rattus norvegicus) | 5171 | 4834 |  |  | 337 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 6607 | 6060 |  |  | 547 | 824 |
| 1.d. | Hamsters (Mesocricetus ) | 263 | 263 |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) |  |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 2205 | 1755 |  |  | 450 | 444 |
| 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) | 14 | 14 |  |  |  |  |
| 1.l. | Pigs (Sus) | 2 | 2 |  |  |  |  |
| 1.m. | Goats (Capra) |  |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 131 | 131 |  |  |  | 11 |
| 1.o. | Cattle (Bos) | 3 | 3 |  |  |  |  |
| 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) | 9 | 9 |  |  |  |  |
| 1.v. | Other birds (other Aves) | 1196 | 943 |  |  | 253 | 12 |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) |  |  |  |  |  |  |
| 1.y. | Fish (Pisces) |  |  |  |  |  |  |
| 1.z. | TOTAL | 60186 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 1448 | 2620 | 8243 | 8008 | 5378 | 17559 | 140 | 1189 | 44585 |
| 2.b. | Rats | 952 | 263 |  |  | 540 | 3266 | 150 |  | 5171 |
| 2.c. | Guinea-Pigs |  | 56 | 2622 | 148 | 671 | 1447 | 1663 |  | 6607 |
| 2.d. | Hamsters | 263 |  |  |  |  |  |  |  | 263 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits |  | 65 | 1409 | 80 | 79 | 526 | 5 | 41 | 2205 |
| 2.g. | Cats |  |  |  |  |  |  |  |  | 0 |
| 2.h. | Dogs |  |  |  |  |  |  |  |  | 0 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds |  | 2 | 9 | 3 |  |  |  |  | 14 |
| 2.l. | Pigs |  |  |  | 2 |  |  |  |  | 2 |
| 2.m. | Goats |  |  |  |  |  |  |  |  | 0 |
| 2.n. | Sheep |  |  | 112 | 2 |  |  |  | 17 | 131 |
| 2.o. | Cattle |  |  | 3 |  |  |  |  |  | 3 |
| 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 |  |  |  |  |  | 9 |  |  | 9 |
| 2.v. | Other birds |  | 66 |  | 747 |  | 286 |  | 97 | 1196 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  | 0 |
| 2.y. | Fish |  |  |  |  |  |  |  |  | 0 |
| 2.z. | TOTAL | 2663 | 3072 | 12398 | 8990 | 6668 | 23093 | 1958 | 1344 | 60186 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nants in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 4808 |  | 50 | 170 | 50 |  |  |  | 300 | 5378 |
| 3.b. | Rats | 50 | 370 | 50 | 20 | 50 |  |  |  |  | 540 |
| 3.c. | Guinea-Pigs | 671 |  |  |  |  |  |  |  |  | 671 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 79 |  |  |  |  |  |  |  |  | 79 |
| 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 | 5608 | 370 | 100 | 190 | 100 | 0 | 0 | 0 | 300 | 6668 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 259 | 236 | 300 | 443 | 1620 | 2858 |
| 4.b. | Rats | 56 | 430 | 250 | 221 |  | 957 |
| 4.c. | Guinea-Pigs |  |  |  | 25 | 4 | 29 |
| 4.d. | Hamsters | 103 | 40 |  | 120 |  | 263 |
| 4.e. | Other Rodents |  |  |  |  |  | 0 |
| 4.f. | Rabbits | 3 |  |  |  | 1 | 4 |
| 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 | 421 | 706 | 550 | 809 | 1625 | 4111 |

  

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 | | |  |  |  | |  |  | 16251 | 16251 |
| 5.b. | Rats | | |  |  |  | |  |  |  | 0 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  | 2770 | 2770 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | |  |  |  | |  |  | 1489 | 1489 |
| 5.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 5.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 5.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 5.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 5.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  | 12 | 12 |
| 5.l. | Pigs | | |  |  |  | |  |  | 2 | 2 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | |  |  |  | |  |  | 114 | 114 |
| 5.o. | Cattle | | |  |  |  | |  |  | 3 | 3 |
| 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 | | |  |  |  | |  |  | 747 | 747 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 0 | 0 | 0 | | 0 | 0 | 21388 | 21388 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | |  |  |  | |  |  | 5378 | 5378 |
| 6.b. | Rats | | |  |  |  | |  |  | 540 | 540 |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  | 671 | 671 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | |  |  |  | |  |  | 79 | 79 |
| 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 | 6668 | 6668 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 40 | 1842 | 82 | 30 | 30 | 30 | 1682 |  |  |  |  |  | 1642 | 5378 |
| 7.b. | Rats | 370 | 20 |  |  |  |  | 5 |  |  |  |  |  | 145 | 540 |
| 7.c. | Guinea-Pigs |  |  |  |  | 669 |  | 2 |  |  |  |  |  |  | 671 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |  |  | 79 | 79 |
| 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 | 410 | 1862 | 82 | 30 | 699 | 30 | 1689 | 0 | 0 | 0 | 0 | 0 | 1866 | 6668 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 320 | 50 | 70 | 30 | 30 | 30 | 50 |  |  |  |  |  | 5028 | 5608 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  |  |  |  |  |  |  |  |  |  |  |  | 370 | 370 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 50 |  | 50 |  |  |  |  |  |  |  |  |  |  | 100 |
| 8.d. | Products/substances used or intended to be used mainly in the household |  |  |  |  |  |  |  |  |  |  |  |  | 190 | 190 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 40 | 5 | 55 |  |  |  |  |  |  |  |  |  |  | 100 |
| 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 |  |  |  |  |  |  |  |  |  |  |  |  | 300 | 300 |
| 8.j. | TOTAL | 410 | 55 | 175 | 30 | 30 | 30 | 50 | 0 | 0 | 0 | 0 | 0 | 5888 | 6668 |

[Top](#document4)

EN

|  |  |
| --- | --- |
|  | EUROPEAN COMMISSION |

Brussels, 30.9.2010

SEC(2010) 1107 final

VOL B - Part IV ([I], [II], [III])

COMMISSION STAFF WORKING DOCUMENT

DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
  
  
Accompanying document to the
  
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT 
  

  
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

COM(2010) 511 final

  

Important notice

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

VOL B - Part IV: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

TABLE OF CONTENTS

SLOVENIA
   5

SLOVAKIA
   16

FINLAND
   28

SWEDEN
   37

UNITED KINGDOM
   47

SLOVENIA

Statistical data submitted

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

Comments of Slovenian authorities

In the Republic of Slovenia, data on the use of animals in experiments are collected on the basis of Article 24 of the Animal Protection Act (ZZZiv-UPB2; UL RS 43/2007). Competent administrative authority for data collection is the Veterinary Administration of the Republic of Slovenia (VARS), a body within the Ministry of Agriculture, Forestry and Food. Organisations using animals in experiments prepare annual statistical reports in the form of tables required by the Rules on conditions for experiments on animals (UL RS 88/2006, 81/2009). These Rules are requiring data presentation on the number, species and origin of animals used in experiments, the number and species of animals used in experiments as to the purpose of use, including details on the use of animals in experiments for the human and animal disease study purposes, for manufacturing and assessing the quality of products and preparations intended for human medicine, dentistry and veterinary medicine, and toxicological testing. Data collection takes place for every calendar year in the form of eight EU tables, which have been harmonised within the EU as to form and scope. Animals actually involved in experiments within the data collection year only shall be presented in the tables. As required by the Animal Protection Act, the final statistical data on the number and species of animals used in experiments and on the types of experiments on animals have been made available to the public as information of public character ever since 2000.

As defined in the Protection of Animals Act, an experiment on an animal means a procedure on a live animal for experimental or other scientific purposes, which may cause pain, suffering, distress or lasting harm to the animal. An experiment on an animal includes other actions, which do or may lead to a birth of an animal in the circumstances as referred to above. The least painful methods of killing or the identification of animals shall not be regarded as experiments. An experiment commences, when an animal is prepared for use in an experiment for the first time, and ends at the point, where any subsequent observation is unnecessary. The use of animals shall be deemed an experiment in cases also, where anaesthetics, analgesics or other methods are used to prevent the suffering, distress or lasting harm to the animals. Before an experiment on animals may commence, the expert on animal welfare within the organisation conducting the experiment shall check whether an adequate animal species has been selected, and whether the test or method has been selected that requires the use of a minimum number of animals, animals with the lowest level of neurophysiological sensitivity, and which will cause the least pain, suffering or lasting harm, and yield satisfactory results. Scientific and research or educational procedures on organs, tissues and carcasses of animals, which had preliminarily been put to death using the required methods, shall not be defined as experiments on animals.

Experiments on animals shall be conducted by organisations only, which have been approved for conducting experiments on animals and duly authorised by VARS. Where in the search for results there are no other satisfactory scientific methods at hand, which would not require the use of animals in experiments, the use of animals shall be authorised for the following purposes: development, manufacture, and testing of quality, effectiveness and safety of medicinal products, foodstuffs and other substances or products for the purposes of avoiding, preventing, diagnosing or treating diseases, disorders and other anomalies or their effects on humans, animals or plants, and for the assessment, detection, remedy or improvement of physiological state in humans, animals and plants. Animals may further be used in experiments for the purposes of protecting the environment, in baseline research studies and, to a limited extent, for the educational and training purposes. VARS may authorise such experiments, provided that they are conducted within the higher education organisations and in accordance with the regulations governing higher education, or within the research organisations and in accordance with the regulations governing the research activities, and which are crucial for obtaining the expertise required by medical doctors in conducting surgery on humans, or by veterinary doctors in conducting surgery on animals, and provided that objectives attainable through experiments cannot be achieved through other teaching aids (videos, figures, models, preparations, etc.). Experiments for ethically inadmissible purposes, as testing of weapons, cosmetic preparations, tobacco or alcohol products, or for tests using muscle paralysing substances and conducted without anaesthesia shall be prohibited.

Where an experiment is absolutely necessary and all other requirements are complied with, VARS may grant an authorisation for conducting the particular experiment or a sequence of experiments on animals to the user organisation and to the particular experiment leader and staff involved, within a limited period of time. The Authorisation shall specify inter alia the purpose of use of animals and the species, number and origin of animals authorised for use in the experiment. In its reasoning, the Authorisation shall list the conditions which shall be complied with before the experiment may commence. Experiments on animals shall not be conducted in cases where there is another acceptable, feasible and scientifically satisfactory and proven method available that does not require the use of animals. Animal species, which shall be reared as laboratory animals in the approved laboratory-animal rearing establishments, and which may be used in experiments, shall include: the mouse (Mus musculus), rat (Rattus norvegicus), guinea pig (Cavia porcellus), golden hamster (Mesocricetus auratus), rabbit (Oryctolagus cuniculus), dog (Canis familiaris), cat (Felis catus), quail (Coturnix coturnix) and non-human primates. Experiments on farmed animals, dogs and cats shall be authorised in cases only, where the purpose of experiment cannot be attained through experiments on other animal species. In exceptional cases, where an experiment is absolutely necessary in order to conserve an animal species, and where the animal in question is the only appropriate one for conducting the experiment, or where such an animal cannot be raised, the authorisation for experiment may be granted by VARS even if such an animal does not come from an organised and registered rearing establishment. Experiments on abandoned animals shall be prohibited.

In 2008, the total number of animals used for experimental and other scientific purposes amounted to 12,438 animals. Most used were laboratory rodents, i.e. 96,4%, and there follow rabbits with 2,5%, birds with 1,0%, and other animals with 0,06%. All laboratory rodents and rabbits used originate from the approved rearing establishments, where one half of approved rearing establishments are situated nationally and the other half in the other EU Member States. Most rodents were used in pharmaceutical industry within the applied research projects for the manufacture and quality control of products and devices intended for human medicine, dentistry and veterinary medicine and, to a lesser extent, within their research and development for the assessment of toxicity. Less rodents were used in biological studies of a fundamental nature. Only a minor number of laboratory rodents and rabbits were used for other purposes, such as educational purposes, other non-defined purposes of use, and for diagnosing diseases. Rabbits were the more frequently used animals in sequences of experiments within the scope of experiments required for the assessment of quality of products intended for human medicine, dentistry and veterinary medicine. As regards farmed animals, three pigs originating from an agricultural holding were used in experiments, based on a preliminary consensus obtained from the animal keeper/breeder, for the educational purposes and training of surgeons in human medicine.

In the Republic of Slovenia, the mean of animals used in experiments in the recent 5 years amounts to around 12,700 animals. Most used are laboratory rodents with around 95%. In the past 2 years, no cats or dogs were used in experiments. Non-human primates are not used in experiments in the Republic of Slovenia. On adoption of relevant legislation and taking into account the 3R principles, and conducting official controls, the use of animals in experiments has decreased. Following the specific training of staff involved in experiments on animals, the responsibility of researchers has increased, and their attitude towards animals used in experiments improved, which is reflected in the accurate experiment protocols, careful selection of methods and subsequent consistent implementation of experiments. The use of validated alternative methods and/or cell cultures and tissues has played an important part in decreasing the number of animals used in experiments particularly in pharmaceutical industry.

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) | 10313 | 4974 | 5339 |  |  |  |
| 1.b. | Rats (Rattus norvegicus) | 1675 | 1142 | 533 |  |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 7 | 7 |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) | 0 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 307 | 29 | 278 |  |  | 278 |
| 1.g. | Cats (Felis catus) | 0 |  |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 0 |  |  |  |  |  |
| 1.i. | Ferrets (Mustela putorius furo) | 0 |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) | 0 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 0 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 3 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 0 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 4 |  |  |  |  |  |
| 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) | 129 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 0 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 0 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 0 |  |  |  |  |  |
| 1.z. | TOTAL | 12438 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 763 | 3009 | 5742 | 285 | 446 | 2 | 36 | 30 | 10313 |
| 2.b. | Rats | 542 | 173 | 434 |  | 512 |  | 14 |  | 1675 |
| 2.c. | Guinea-Pigs | 7 |  |  |  |  |  |  |  | 7 |
| 2.d. | Hamsters |  |  |  |  |  |  |  |  | 0 |
| 2.e. | Other Rodents |  |  |  |  |  |  |  |  | 0 |
| 2.f. | Rabbits |  |  | 292 |  | 3 |  | 12 |  | 307 |
| 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 |  |  |  |  |  |  | 3 |  | 3 |
| 2.m. | Goats |  |  |  |  |  |  |  |  | 0 |
| 2.n. | Sheep | 4 |  |  |  |  |  |  |  | 4 |
| 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 | 3 |  |  | 126 |  |  |  |  | 129 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  | 0 |
| 2.y. | Fish |  |  |  |  |  |  |  |  | 0 |
| 2.z. | TOTAL | 1319 | 3182 | 6468 | 411 | 961 | 2 | 65 | 30 | 12438 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nants in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 50 |  |  |  |  |  |  |  | 396 | 446 |
| 3.b. | Rats | 512 |  |  |  |  |  |  |  |  | 512 |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 3 |  |  |  |  |  |  |  |  | 3 |
| 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 | 565 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 396 | 961 |

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice |  | 20 | 2764 | 268 | 366 | 3418 |
| 4.b. | Rats |  | 199 | 3 | 197 | 102 | 501 |
| 4.c. | Guinea-Pigs |  |  |  | 7 |  | 7 |
| 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 | 219 | 2767 | 472 | 468 | 3926 |

  

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 | | |  | 6027 |  | |  |  |  | 6027 |
| 5.b. | Rats | | |  | 434 |  | |  |  |  | 434 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | |  | 292 |  | |  |  |  | 292 |
| 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 | | |  |  |  | |  |  | 126 | 126 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 0 | 6753 | 0 | | 0 | 0 | 126 | 6879 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 314 |  |  | |  | 50 | 82 | 446 |
| 6.b. | Rats | | |  | 512 |  | |  |  |  | 512 |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | |  |  |  | |  |  | 3 | 3 |
| 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 | | | 314 | 512 | 0 | | 0 | 50 | 85 | 961 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  | 364 |  |  |  |  |  |  |  |  |  |  | 82 | 446 |
| 7.b. | Rats | 250 |  |  |  |  |  | 260 |  |  | 2 |  |  |  | 512 |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  | 3 |  |  |  |  |  |  |  |  |  | 3 |
| 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 | 250 | 364 | 0 | 3 | 0 | 0 | 260 | 0 | 0 | 2 | 0 | 0 | 82 | 961 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 250 | 50 |  | 3 |  |  | 260 |  |  | 2 |  |  |  | 565 |
| 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 |  | 314 |  |  |  |  |  |  |  |  |  |  | 82 | 396 |
| 8.j. | TOTAL | 250 | 364 | 0 | 3 | 0 | 0 | 260 | 0 | 0 | 2 | 0 | 0 | 82 | 961 |

SLOVAKIA

Statistical data submitted

The statistical data have been submitted by the State Veterinary and Food Administration of the Slovak Republic.

Comments of Slovakian authorities

The State Veterinary and Food Administration of the Slovak Republic (hereinafter “SVFA SR“) is a competent authority in the Slovak Republic in the area of protection of animals used for experimental purposes. The SVFA SR approves in compliance with Article 6(2) letter i), (3) and (4) of the Act No. 39/2007 Coll. on Veterinary Care and on Amendment to Some Laws as later amended (Act No. 299/2009 Coll.), (hereinafter „Act No. 39/2007 Coll.“) and in compliance with Articles 8, 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 experimental, breeding and supplying establishments and all the experiments performed using animals. Each approved establishment is kept by the SVFA SR on the list of approved establishments on the website of SVFA SR www.svssr.sk in compliance with Article 39 of the Act No. 39/2007 Coll.

The SVFA SR is comprised of 8 Regional Veterinary and Food Administrations (hereinafter RVFA) and 40 District Veterinary and Food Administrations (hereinafter DVFA). All the employees of the veterinary administration in the field of animal welfare are veterinarians.

All kinds of establishments are approved by the SVFA SR based on results on assessment of the suitability of establishment in accordance with requirements of the Ordinance of the Government of Slovak Republic No. 289/2003 Coll. Animal welfare inspectors shall be obliged, in compliance with Articles 6, 7 and 8 of the Act 39/2007 Coll. to perform non-discriminatory controls of all approved establishments. The SVFA SR, as a competent authority, trained both theoretically and practically all the animal welfare inspectors (RVFA, DVFA) for the performance of the control. Controls are performed according to methodical instructions and checklists worked out by the competent authority in compliance with requirements laid down in the Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. and in the Act 39/2007 Coll.

Based on applicant’s applications in the year 2008, the SVFA SR approved totally 3 new experimental establishments, from that 1 breeding establishment for breeding of experimental animals and 2 establishments for carrying out projects. 3 establishments were subjects of control due to increased number of animals in single-use capacity and another 3 establishments were subjects of control due to use of a new species of an experimental animal.

  

Total number of establishments in the Slovak Republic in the year 2008

|  |  |
| --- | --- |
| Kind of establishment | Number |
| Experimental establishment | 46 |
| Experimental establishment with breeding of animals for own use | 20 |
| Breeding establishment | 8 |
| Supplying establishment | 1 |
| Total: | 75 |

The SVFA SR approves the experiments performed upon animals based on the application for approval of the experiment submitted by an applicant - approved experimental establishment. Each application for approval of an experiment shall be submitted by an applicant in compliance with Article 20 of the Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. in order to be judged by the Ethic Commission. Each approved experimental establishment shall have founded its own ethic commission comprised of minimum 5 members, out of which 1/3 must not be dependent from the experimental establishment. Ethic commission, on the submitted project of an experiment, shall assess observance of 3R, existence of alternative method contrary to presented project, justification of each experiment, use of the animals in the experiment and specification of species and number of animals in the experiment. An applicant may submit his/her project of an experiment for approval by the SVFA SR only after recommendation for submission, issued by the ethic commission. The SVFA SR has in compliance with the Act No. 71/1967 Coll. on Administrative Proceedings (Administrative Codex) minimum 30 days for assessment of an application for approval of the experiment. The SVFA SR as a competent authority shall issue a decision by which the performance of the experiment and administrative proceeding may be approved, refused, suspended or stopped. The SVFA SR in case of the need of professional consultation concerning the aim of the experiment, the need of use of the animals in the experiment and the number of used animals shall ask the members of the advisory body for their opinion – to the submitted application for approval of the experiment – with observance of rules of personal data protection and protection of trade secret data or intellectual property.

Table No. 1: Most of experimental animals originate in domestic breeding establishments or in experimental establishments with breeding of animals for use within that establishment. As far as foreign suppliers are concerned, the animals originate mainly from the EU Member States (Czech Republic, Hungary, Germany, Poland and France) as well as from countries are signatories to ETS 123. The number of 25 fish marked in column 1.6 as "animals coming from other origins" was entered incorrectly – these fish originate from the Slovak republic. We do apologise incorrect information being provided.

Table No. 2: The SVFA SR approved 273 experiments with use of experimental animals; stopped the proceeding in 4 applications; refused 5 applications for approval of the experiment and suspended the proceeding in 36 applications in the year 2008. The total number of 19,260 animals used does not reflect the number of approved experiments in the year 2008, because within the total of the number of animals used are included also the animals which were used in the year 2008 from the experiments approved in the year 2005, 2006, 2007 and 2008. Number of animals used in preparatory studies for performed projects is listed in the column 2.8. Animals were used for introduction of new surgical methods practised during projects. Some preparatory studies were approved as individual projects. Numbers of animals used for training of persons involved in projects were approved as pre-experiment within the project in some cases.

Table No. 3: Most animals indicated in the column 3.2 were used for evaluation of products and substances for human medicine (testing of new drugs, medical supplies, surgical supplies – collagen surgical implants). In the column 3.3 the animals were used for control of products/substances used in agriculture – mainly pesticide, herbicide, rodenticide products, growth stimulators for plants and biocide substances. In the column 3.4 the animals used for control of various chemical products/ substances being a part of oils, lubricants and rubber industry materials are indicated. The orders for re-test of the same substance produced in various batches were done in several establishments. In some cases, whole series of standard toxicological safety tests were carried out with the same substance, depending on EU legislation (REACH).

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

Table No. 5: In the Slovak Republic the experiments on animals are performed in compliance with the valid Slovak legislation, in which the legal acts of the European Communities and the European Union are incorporated. The experiments are performed in compliance with the valid legislation of the European Pharmacopoeia in the column 5.3 while in the column 5.7 the methods in control of human products/substances were used that were created by the experimental establishment as a modified method based on the approved pharmacopoeia methods or as a new individual method.

Table No. 6: The Slovak Republic has elaborated the valid legislation for the control of drugs – Act No. 140/1998 Coll. – Act On Medicinal Products and Medical Devices as amended; for the control of chemical substances and preparations the Act No. 163/2001 Coll. on Chemical Substances and Preparations; Decree of the Ministry of Economy No. 2/2005 Annex 5 Part B Methods B, that are conformable to OECD methods. In the column 6.3 the number of animals used in compliance with the European Pharmacopoeia are indicated, in the column 6.7 a total of 4 rabbits and 70 mice were used in product quality testing: testing of efficiency on and harm to animals. These projects are usually carried out mainly according to European Pharmacopoeia 4 and Slovak Pharmacopoeia but this single project was performed in accordance with obligatory safety control test described in producer’s documentation.

Table No. 7: In the column 7.2.1. the animals were used only in the 'limit test'. Tests were performed mainly by OECD methods TG 402 and 403 while in the column 7.2.2. the OECD tests TG 423, B.1 tris were performed. In the column 7.2.3 mainly tests in compliance with OECD TG 407, 420 and tolerance studies were performed; in the column 7.12 were animals used in studies for determination of minimal lethal and maximal non-lethal dose of certain substance (food additive); determination of MDT minimal comparative dose of certain substances; harvesting of hepatic S9 fraction for testing of metabolic activation in vitro genotoxicity.

In compliance with Article 17 paragraph 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 its authorisation, to submit yearly by the end of January for the previous year to the SVFA SR a notification on the number of animals used according to the specimen laid down in the Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. Approved establishments shall be obliged to keep records about the number of GMO animals used in procedures. Based on collected data the SVFA SR shall work out on an annual basis a notification concerning the activity of the SVFA SR in which the numbers of approved establishments and approved or refused experiments, as well as numbers and species of used animals in the experiment for the respective year are published.

The purpose of inspections in approved establishments is to control the observance of requirements indicated in the Act No. 39/2007 Coll., in the Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. and the compliance of the performed project in approved establishment with the project authorisation issued by SVFA SR. Finding of infringements laid down in the Act No. 39/2007 Coll. and in the Ordinance of the Government of the Slovak Republic No. 289/2003 Coll. is classified as an administrative delict for which a penalty may be imposed on a legal or natural person in compliance with the Act No. 39/2007 Coll.

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

The competent authority performs consulting services for the public in the field of animal welfare, organizes trainings for employees of approved establishments the purpose of which is interpretation of the valid legislation of the Slovak Republic in the field of animal welfare. The SVFA SR organizes also seminars and lectures aimed at protection of experimental animals used for experimental purposes. The owner, keeper and dealer of an animal – in compliance with the Article 37 of the Act. No. 39/2007 Coll. – shall be obliged to educate demonstrably the persons handling the animals so that such persons must avoid any acts that might cause injury or any other damage to the health of animals or unnecessary suffering thereof.

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) | 6942 | 5229 | 1713 |  |  |  |
| 1.b. | Rats (Rattus norvegicus) | 9692 | 6767 | 2789 | 136 |  |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 982 | 536 | 446 |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 0 |  |  |  |  |  |
| 1.e. | Other Rodents (other Rodentia) | 45 | 45 |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 679 | 646 | 33 |  |  |  |
| 1.g. | Cats (Felis catus) | 18 |  | 18 |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 4 |  | 4 |  |  |  |
| 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) | 22 | 22 |  |  |  | 1 |
| 1.m. | Goats (Capra) | 5 | 5 |  |  |  |  |
| 1.n. | Sheep (Ovis) | 9 | 9 |  |  |  |  |
| 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) | 21 | 21 |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 120 | 120 |  |  |  |  |
| 1.v. | Other birds (other Aves) | 696 | 438 | 258 |  |  |  |
| 1.w. | Reptiles (Reptilia) |  |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) |  |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 25 |  |  |  | 25 |  |
| 1.z. | TOTAL | 19260 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 1199 | 2007 |  | 280 | 610 | 2716 | 80 | 50 | 6942 |
| 2.b. | Rats | 4284 | 2734 | 60 |  | 1371 |  | 25 | 1218 | 9692 |
| 2.c. | Guinea-Pigs | 176 | 344 |  |  | 421 |  |  | 41 | 982 |
| 2.d. | Hamsters |  |  |  |  |  |  |  |  | 0 |
| 2.e. | Other Rodents | 45 |  |  |  |  |  |  |  | 45 |
| 2.f. | Rabbits | 478 | 60 | 66 | 16 | 24 |  |  | 35 | 679 |
| 2.g. | Cats | 18 |  |  |  |  |  |  |  | 18 |
| 2.h. | Dogs |  |  |  |  | 4 |  |  |  | 4 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores |  |  |  |  |  |  |  |  | 0 |
| 2.k. | Horses, donkeys and cross breds |  |  |  |  |  |  |  |  | 0 |
| 2.l. | Pigs | 12 | 10 |  |  |  |  |  |  | 22 |
| 2.m. | Goats |  |  |  |  |  |  |  | 5 | 5 |
| 2.n. | Sheep | 9 |  |  |  |  |  |  |  | 9 |
| 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 | 21 |  |  |  |  |  |  |  | 21 |
| 2.u. | Quail | 120 |  |  |  |  |  |  |  | 120 |
| 2.v. | Other birds | 208 |  |  | 333 | 155 |  |  |  | 696 |
| 2.w. | Reptiles |  |  |  |  |  |  |  |  | 0 |
| 2.x. | Amphibians |  |  |  |  |  |  |  |  | 0 |
| 2.y. | Fish |  |  |  |  | 25 |  |  |  | 25 |
| 2.z. | TOTAL | 6570 | 5155 | 126 | 629 | 2610 | 2716 | 105 | 1349 | 19260 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nants in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 507 | 103 |  |  |  |  |  |  |  | 610 |
| 3.b. | Rats | 40 | 50 | 941 |  |  | 155 | 100 | 85 |  | 1371 |
| 3.c. | Guinea-Pigs | 15 | 406 |  |  |  |  |  |  |  | 421 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 12 | 12 |  |  |  |  |  |  |  | 24 |
| 3.g. | Cats |  |  |  |  |  |  |  |  |  | 0 |
| 3.h. | Dogs | 4 |  |  |  |  |  |  |  |  | 4 |
| 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 | 155 |  |  |  |  |  |  |  |  | 155 |
| 3.w. | Reptiles |  |  |  |  |  |  |  |  |  | 0 |
| 3.x. | Amphibians |  |  |  |  |  |  |  |  |  | 0 |
| 3.y. | Fish |  |  |  |  |  |  |  |  | 25 | 25 |
| 3.z. | TOTAL | 733 | 571 | 941 | 0 | 0 | 155 | 100 | 85 | 25 | 2610 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice |  | 115 | 1439 | 2411 | 1957 | 5922 |
| 4.b. | Rats | 2426 | 1822 | 584 | 2149 | 37 | 7018 |
| 4.c. | Guinea-Pigs |  |  |  | 520 |  | 520 |
| 4.d. | Hamsters |  |  |  |  |  | 0 |
| 4.e. | Other Rodents |  | 25 |  |  | 20 | 45 |
| 4.f. | Rabbits |  | 12 |  | 511 | 15 | 538 |
| 4.g. | Cats |  |  |  | 18 |  | 18 |
| 4.h. | Dogs |  |  |  |  |  | 0 |
| 4.i. | Ferrets |  |  |  |  |  | 0 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds |  |  |  |  |  | 0 |
| 4.l. | Pigs |  |  |  |  | 22 | 22 |
| 4.m. | Goats |  |  |  |  |  | 0 |
| 4.n. | Sheep |  |  |  | 9 |  | 9 |
| 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 |  |  |  | 21 |  | 21 |
| 4.u. | Quail |  |  |  | 120 |  | 120 |
| 4.v. | Other birds |  |  |  | 88 | 120 | 208 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  |  |  |  |  | 0 |
| 4.y. | Fish |  |  |  |  |  | 0 |
| 4.z. | TOTAL | 2426 | 1974 | 2023 | 5847 | 2171 | 14441 |

  

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 | | |  | 200 |  | |  |  | 80 | 280 |
| 5.b. | Rats | | | 60 |  |  | |  |  |  | 60 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | | 10 |  |  | |  |  | 72 | 82 |
| 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 | | | 258 | 60 |  | |  |  | 15 | 333 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 328 | 260 | 0 | | 0 | 0 | 167 | 755 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | |  | 540 |  | |  |  | 70 | 610 |
| 6.b. | Rats | | | 412 | 959 |  | |  |  |  | 1371 |
| 6.c. | Guinea-Pigs | | |  | 421 |  | |  |  |  | 421 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | | 12 | 8 |  | |  |  | 4 | 24 |
| 6.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 6.h. | Dogs | | |  | 4 |  | |  |  |  | 4 |
| 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 | | |  | 155 |  | |  |  |  | 155 |
| 6.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 6.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 6.y. | Fish | | | 25 |  |  | |  |  |  | 25 |
| 6.z. | TOTAL | | | 449 | 2087 | 0 | | 0 | 0 | 74 | 2610 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 21 |  | 220 |  | 35 |  |  |  |  | 334 |  |  |  | 610 |
| 7.b. | Rats |  | 144 | 287 |  |  |  | 560 |  | 85 | 15 |  |  | 280 | 1371 |
| 7.c. | Guinea-Pigs |  |  | 15 |  | 406 |  |  |  |  |  |  |  |  | 421 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  | 4 | 6 |  | 14 |  |  |  |  |  |  |  | 24 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.h. | Dogs |  |  |  |  |  |  |  |  |  |  |  |  | 4 | 4 |
| 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 |  |  | 90 |  |  | 65 |  |  |  |  |  |  |  | 155 |
| 7.w. | Reptiles |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.x. | Amphibians |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.y. | Fish |  | 25 |  |  |  |  |  |  |  |  |  |  |  | 25 |
| 7.z. | TOTAL | 21 | 169 | 616 | 6 | 441 | 79 | 560 | 0 | 85 | 349 | 0 | 0 | 284 | 2610 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 21 |  | 329 |  |  | 73 | 40 |  |  | 266 |  |  | 4 | 733 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  | 50 |  |  | 441 |  |  |  |  | 68 |  |  | 12 | 571 |
| 8.c. | Products/substances used or intended to be used mainly in industry |  | 54 | 157 | 6 |  | 6 | 450 |  |  |  |  |  | 268 | 941 |
| 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 |  | 40 | 30 |  |  |  | 70 |  |  | 15 |  |  |  | 155 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption |  |  | 100 |  |  |  |  |  |  |  |  |  |  | 100 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns |  |  |  |  |  |  |  |  | 85 |  |  |  |  | 85 |
| 8.i. | Other toxicological or safety evaluations |  | 25 |  |  |  |  |  |  |  |  |  |  |  | 25 |
| 8.j. | TOTAL | 21 | 169 | 616 | 6 | 441 | 79 | 560 | 0 | 85 | 349 | 0 | 0 | 284 | 2610 |

FINLAND

Statistical data submitted

The data were submitted by the Ministry of Agriculture and Forestry

Comments of Finnish authorities

The years 2006-2008 have been a transition period after the new Act and Decree on Animal Experimentation for Finland (2006) came into force, and the national Animal Experiment Board took over the responsibility of granting authorisation for all the experiments with vertebrate animals in Finland. The number of animals used yearly in experiments has been reduced throughout these 3 years, partly due to change in authorisation practices.

In 2008 a total of 138,600 experimental animals were used in Finland, which is 17% less than in 2007. Of all experimental animals used 78% were rodents, and 74% mice (about 78,500 animals used) and rats (26,000, respectively). Fish accounted for about 21,000 animals, and birds other than quails about 5,500 animals. The use of other species was at the level 30 – 850 animals.

There was a decrease in the number of mice used in experiments in 2008 (-22%) in comparison to the previous year. Also use of rats was slightly decreased (-9%). The change was, however, at least partly due to change in authorisation practices.

When compared to year 2005, the total number of animals used was dropped from 256,826 (163,606 without fish) to 138,600 (117,522 without fish), which is 46% reduction (28% without fish). Here also, the reduction is mainly due to the change in authorisation practices.

As in previous years, a major part of the animals (77%) was used for biological studies of a fundamental nature (2005: 87%, 2007: 82%). Animal use in 2008 for human and veterinary medicine research and quality control was 20% (2005: 9,3%, 2007: 15%), for toxicological and other safety evaluations 1,1 % (2005: 0,9, 2007: 1,2 %), for diagnosis of disease 0,1 % (2005: 0,2%, 2007: 0,24%), for education and training 1,0 % (2005: 1,8%, 2007: 0,89%) and other uses 1,00 % (2005: 0,9%, 2007: 0,48%) of the total number of experimental animals used.

The national Animal Experiment Board evaluated and was responsible for granting authorisation for all the experiments with vertebrate animals in Finland. The Board works on two levels: the local level in the form of four local subcommittees having the authority to grant an experiment when unanimous. In case of disagreement the decision is taken by the full national Board. In 2008 a total of 362 authorisations were granted by the Board: 287 for new experiment and 75 for changes in ongoing experiment.

In 2008 the Ministry of Agriculture and Forestry provided 40,000€ to the Finnish research community for studies to replace existing techniques using experimental animals with alternative methods.

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) | 78446 | 56285 | 18160 | 2464 | 1537 |  |
| 1.b. | Rats (Rattus norvegicus) | 26058 | 7989 | 16756 | 25 | 1288 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 215 | 4 | 211 |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 302 |  | 302 |  |  |  |
| 1.e. | Other Rodents (other Rodentia) | 3142 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 814 | 250 | 564 |  |  | 32 |
| 1.g. | Cats (Felis catus) |  |  |  |  |  |  |
| 1.h. | Dogs (Canis familiaris) | 54 |  | 54 |  |  |  |
| 1.i. | Ferrets (Mustela putorius furo) |  |  |  |  |  |  |
| 1.j. | Other Carnivores (other Carnivora) | 761 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 37 | 37 |  |  |  |  |
| 1.l. | Pigs (Sus) | 819 |  |  |  |  |  |
| 1.m. | Goats (Capra) |  |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 571 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 300 |  |  |  |  |  |
| 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) | 84 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) |  |  |  |  |  |  |
| 1.v. | Other birds (other Aves) | 5568 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 317 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 34 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 21078 |  |  |  |  |  |
| 1.z. | TOTAL | 138600 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 66628 | 11186 | 30 |  | 20 | 89 | 426 | 67 | 78446 |
| 2.b. | Rats | 12548 | 12317 |  |  | 608 | 34 | 382 | 169 | 26058 |
| 2.c. | Guinea-Pigs | 16 | 195 |  |  |  |  |  | 4 | 215 |
| 2.d. | Hamsters | 24 | 278 |  |  |  |  |  |  | 302 |
| 2.e. | Other Rodents | 3072 | 70 |  |  |  |  |  |  | 3142 |
| 2.f. | Rabbits | 518 | 248 |  |  | 12 | 10 | 10 | 16 | 814 |
| 2.g. | Cats |  |  |  |  |  |  |  |  | 0 |
| 2.h. | Dogs |  | 8 |  |  | 43 |  |  | 3 | 54 |
| 2.i. | Ferrets |  |  |  |  |  |  |  |  | 0 |
| 2.j. | Other Carnivores | 761 |  |  |  |  |  |  |  | 761 |
| 2.k. | Horses, donkeys and cross breds | 33 |  |  | 3 |  |  | 1 |  | 37 |
| 2.l. | Pigs | 267 | 149 | 318 |  |  |  | 39 | 46 | 819 |
| 2.m. | Goats |  |  |  |  |  |  |  |  | 0 |
| 2.n. | Sheep | 18 | 29 | 520 |  |  |  |  | 4 | 571 |
| 2.o. | Cattle | 19 | 10 |  |  |  |  | 203 | 68 | 300 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals | 84 |  |  |  |  |  |  |  | 84 |
| 2.u. | Quail |  |  |  |  |  |  |  |  | 0 |
| 2.v. | Other birds | 4779 |  |  | 265 |  |  | 54 | 470 | 5568 |
| 2.w. | Reptiles | 317 |  |  |  |  |  |  |  | 317 |
| 2.x. | Amphibians | 7 |  |  |  |  |  | 27 |  | 34 |
| 2.y. | Fish | 17344 |  |  | 2215 | 798 |  | 185 | 536 | 21078 |
| 2.z. | TOTAL | 106435 | 24490 | 868 | 2483 | 1481 | 133 | 1327 | 1383 | 138600 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nents in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 20 |  |  |  |  |  |  |  |  | 20 |
| 3.b. | Rats | 608 |  |  |  |  |  |  |  |  | 608 |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.d. | Hamsters |  |  |  |  |  |  |  |  |  | 0 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 12 |  |  |  |  |  |  |  |  | 12 |
| 3.g. | Cats |  |  |  |  |  |  |  |  |  | 0 |
| 3.h. | Dogs | 43 |  |  |  |  |  |  |  |  | 43 |
| 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 |  |  |  |  |  |  |  |  | 798 | 798 |
| 3.z. | TOTAL | 683 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 798 | 1481 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 2935 | 12967 | 5328 | 8799 |  | 30029 |
| 4.b. | Rats | 3842 | 6958 | 1009 | 4938 | 1 | 16748 |
| 4.c. | Guinea-Pigs | 184 | 9 |  |  |  | 193 |
| 4.d. | Hamsters | 227 | 51 |  |  |  | 278 |
| 4.e. | Other Rodents |  | 70 | 24 |  |  | 94 |
| 4.f. | Rabbits | 463 |  | 41 | 201 |  | 705 |
| 4.g. | Cats |  |  |  |  |  | 0 |
| 4.h. | Dogs |  |  |  |  | 8 | 8 |
| 4.i. | Ferrets |  |  |  |  |  | 0 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds |  |  |  |  |  | 0 |
| 4.l. | Pigs | 305 |  |  | 52 |  | 357 |
| 4.m. | Goats |  |  |  |  |  | 0 |
| 4.n. | Sheep | 18 |  |  | 11 |  | 29 |
| 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 |  |  |  |  | 647 | 647 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians |  |  |  |  |  | 0 |
| 4.y. | Fish |  |  |  |  | 2715 | 2715 |
| 4.z. | TOTAL | 7974 | 20055 | 6402 | 14001 | 3371 | 51803 |

  

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 | | | 30 |  |  | |  |  |  | 30 |
| 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 | | |  |  |  | |  |  | 3 | 3 |
| 5.l. | Pigs | | | 318 |  |  | |  |  |  | 318 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | | 520 |  |  | |  |  |  | 520 |
| 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 | | |  |  |  | | 265 |  |  | 265 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  | 2215 | 2215 |
| 5.z. | TOTAL | | | 868 | 0 | 0 | | 265 | 0 | 2218 | 3351 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 - Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 20 |  |  | |  |  |  | 20 |
| 6.b. | Rats | | | 608 |  |  | |  |  |  | 608 |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 6.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | | 12 |  |  | |  |  |  | 12 |
| 6.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 6.h. | Dogs | | | 43 |  |  | |  |  |  | 43 |
| 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 | | |  |  |  | |  |  | 798 | 798 |
| 6.z. | TOTAL | | | 683 | 0 | 0 | | 0 | 0 | 798 | 1481 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice |  |  |  |  |  |  | 20 |  |  |  |  |  |  | 20 |
| 7.b. | Rats | 19 |  |  |  |  |  | 304 |  |  |  |  |  | 285 | 608 |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.d. | Hamsters |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  |  |  |  |  |  |  |  |  |  |  | 12 | 12 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.h. | Dogs |  |  |  |  |  |  | 43 |  |  |  |  |  |  | 43 |
| 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 |  |  |  |  |  |  |  |  |  |  | 798 |  |  | 798 |
| 7.z. | TOTAL | 19 | 0 | 0 | 0 | 0 | 0 | 367 | 0 | 0 | 0 | 798 | 0 | 297 | 1481 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 19 |  |  |  |  |  | 367 |  |  |  |  |  | 297 | 683 |
| 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 |  |  |  |  |  |  |  |  |  |  | 798 |  |  | 798 |
| 8.i. | Other toxicological or safety evaluations |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 8.j. | TOTAL | 19 | 0 | 0 | 0 | 0 | 0 | 367 | 0 | 0 | 0 | 798 | 0 | 297 | 1481 |

SWEDEN

Statistical data submitted

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

Comments of Swedish authorities

The Swedish Board of Agriculture hereby submits comments on the statistical data regarding the use of laboratory animals in Sweden for 2008.

According to the EU definition (directive 86/609/EEC), the number of laboratory animals used during 2008 in Sweden was 501,499 including reused animals and 484,604 excluding reused animals. This is a small decrease compared to the 505,600 animals reported for 2005 and reflects well the minor fluctuation in the number of laboratory animals used in Sweden that has been seen during the last 5 years.

From 1990 until 2002, the mean number of laboratory animals used in Sweden was about 315,000 with the highest number 1994 (approximately 351,000) and the lowest 1997 (approximately 267,000). From 2003-2008, however, there has been an increase in the number of animals used due to the fact that tagging of fish for assessment studies have been included. During 2008, the number of fish used for this purpose was 200,243. Apart from fish, mice and rats are the animals predominately used in animal experimentation in Sweden. During the last 10 years the trend has been an increase in the use of mice whereas the use of rats, rabbits and guinea pigs has decreased. The increased use of mice as laboratory animals is most probably due to the increased use of transgenic technique(s).

![](./../../../resource.html?uri=comnat:sec2010_1107en01_55.xhtml.62002.jpg)

  

Specific use of animals

As in previous years, most laboratory animals used during 2008 were used for fundamental biological research. The large proportion of animals used for other purposes can be explained by the tagging of fish in assessment studies.

Only 2% of the animals were used in toxicological research, and the most common animals used in toxicological research were rats, mice and fish.

Swedish definition

According to Swedish legislation, all use of animals with a scientific purpose is defined as animal experimentation. Sweden therefore also collects statistical data on for example animals used in behaviour studies, feeding trials and animals being killed for the use of their tissues and organs. During 2008, 528,663 animals were reported being used for these purposes. In addition, Sweden also keeps statistical records on fish used in assessment studies, caught by trawling, netting etc. During 2008 the number of fish in this category was approximately 6,806,700.

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) | 203112 | 197709 | 2763 |  | 2640 |  |
| 1.b. | Rats (Rattus norvegicus) | 53141 | 25727 | 27348 |  | 66 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 1766 | 1766 |  |  |  |  |
| 1.d. | Hamsters (Mesocricetus ) | 864 |  | 864 |  |  |  |
| 1.e. | Other Rodents (other Rodentia) | 2033 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 1332 | 1332 |  |  |  | 13 |
| 1.g. | Cats (Felis catus) | 149 |  | 21 | 7 | 121 |  |
| 1.h. | Dogs (Canis familiaris) | 1982 | 450 | 36 | 47 | 1449 | 222 |
| 1.i. | Ferrets (Mustela putorius furo) | 39 | 39 |  |  |  | 0 |
| 1.j. | Other Carnivores (other Carnivora) | 53 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 423 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 1973 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 5 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 152 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 1379 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 |  |  |  |  |  |
| 1.q. | New World Monkeys (Ceboidea) | 0 |  |  |  |  |  |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 35 |  |  |  | 35 | 11 |
| 1.s. | Apes (Hominoidea) | 0 |  |  |  |  |  |
| 1.t. | Other Mammals (other Mammalia) | 263 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 201 | 201 |  |  |  |  |
| 1.v. | Other birds (other Aves) | 3432 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 170 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 641 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 211459 |  |  |  |  |  |
| 1.z. | TOTAL | 484604 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

  

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 127301 | 64066 | 140 | 516 | 2305 | 1685 | 689 | 6410 | 203112 |
| 2.b. | Rats | 22531 | 24299 | 0 | 10 | 5225 | 70 | 486 | 520 | 53141 |
| 2.c. | Guinea-Pigs | 276 | 1455 | 12 | 14 | 0 | 0 | 5 | 4 | 1766 |
| 2.d. | Hamsters | 6 | 661 | 0 | 0 | 135 | 0 | 62 | 0 | 864 |
| 2.e. | Other Rodents | 2033 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2033 |
| 2.f. | Rabbits | 309 | 401 | 11 | 1 | 371 | 0 | 16 | 223 | 1332 |
| 2.g. | Cats | 32 | 0 | 0 | 0 | 0 | 105 | 0 | 12 | 149 |
| 2.h. | Dogs | 548 | 175 | 0 | 0 | 546 | 701 | 12 | 0 | 1982 |
| 2.i. | Ferrets | 39 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 39 |
| 2.j. | Other Carnivores | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 53 | 53 |
| 2.k. | Horses, donkeys and cross breds | 253 | 0 | 0 | 8 | 0 | 0 | 162 | 0 | 423 |
| 2.l. | Pigs | 951 | 265 | 0 | 0 | 0 | 0 | 757 | 0 | 1973 |
| 2.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 5 |
| 2.n. | Sheep | 19 | 40 | 0 | 12 | 0 | 0 | 53 | 28 | 152 |
| 2.o. | Cattle | 135 | 856 | 0 | 3 | 0 | 0 | 276 | 109 | 1379 |
| 2.p. | Prosimians |  |  |  |  |  |  |  |  | 0 |
| 2.q. | New World Monkeys |  |  |  |  |  |  |  |  | 0 |
| 2.r. | Old World Monkeys | 0 | 35 | 0 | 0 | 0 | 0 | 0 | 0 | 35 |
| 2.s. | Apes |  |  |  |  |  |  |  |  | 0 |
| 2.t. | Other Mammals | 208 | 0 | 0 | 0 | 0 | 0 | 0 | 55 | 263 |
| 2.u. | Quail | 151 | 0 | 0 | 0 | 0 | 0 | 0 | 50 | 201 |
| 2.v. | Other birds | 401 | 45 | 60 | 43 | 0 | 146 | 0 | 2737 | 3432 |
| 2.w. | Reptiles | 170 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 170 |
| 2.x. | Amphibians | 641 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 641 |
| 2.y. | Fish | 6852 | 1671 | 0 | 0 | 1370 | 0 | 42 | 201524 | 211459 |
| 2.z. | TOTAL | 162856 | 93969 | 223 | 607 | 9952 | 2707 | 2560 | 211730 | 484604 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nants in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 636 |  |  | 1620 |  |  |  | 49 |  | 2305 |
| 3.b. | Rats | 5225 |  |  |  |  |  |  |  |  | 5225 |
| 3.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  | 0 |
| 3.d. | Hamsters | 135 |  |  |  |  |  |  |  |  | 135 |
| 3.e. | Other Rodents |  |  |  |  |  |  |  |  |  | 0 |
| 3.f. | Rabbits | 371 |  |  |  |  |  |  |  |  | 371 |
| 3.g. | Cats |  |  |  |  |  |  |  |  |  | 0 |
| 3.h. | Dogs | 546 |  |  |  |  |  |  |  |  | 546 |
| 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 |  | 250 |  |  |  |  |  | 1060 | 60 | 1370 |
| 3.z. | TOTAL | 6913 | 250 | 0 | 1620 | 0 | 0 | 0 | 1109 | 60 | 9952 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 30075 | 33514 | 29932 | 89604 | 1627 | 184752 |
| 4.b. | Rats | 4439 | 20559 | 1365 | 17804 | 28 | 44195 |
| 4.c. | Guinea-Pigs | 88 | 1070 | 0 | 583 | 16 | 1757 |
| 4.d. | Hamsters | 636 | 0 | 0 | 31 | 0 | 667 |
| 4.e. | Other Rodents | 57 | 0 | 0 | 10 | 1966 | 2033 |
| 4.f. | Rabbits | 201 | 99 | 9 | 412 | 1 | 722 |
| 4.g. | Cats | 0 | 16 | 0 | 0 | 107 | 123 |
| 4.h. | Dogs | 90 | 12 | 0 | 73 | 1221 | 1396 |
| 4.i. | Ferrets | 0 | 39 | 0 | 0 | 0 | 39 |
| 4.j. | Other Carnivores |  |  |  |  |  | 0 |
| 4.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 69 | 69 |
| 4.l. | Pigs | 467 | 65 | 0 | 430 | 145 | 1107 |
| 4.m. | Goats |  |  |  |  |  | 0 |
| 4.n. | Sheep | 40 | 0 | 0 | 17 | 14 | 71 |
| 4.o. | Cattle | 1 | 0 | 0 | 0 | 859 | 860 |
| 4.p. | Prosimians |  |  |  |  |  | 0 |
| 4.q. | New World Monkeys |  |  |  |  |  | 0 |
| 4.r. | Old World Monkeys | 0 | 6 | 6 | 23 | 0 | 35 |
| 4.s. | Apes |  |  |  |  |  | 0 |
| 4.t. | Other Mammals | 0 | 0 | 0 | 0 | 208 | 208 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 151 | 151 |
| 4.v. | Other birds | 2 | 0 | 45 | 218 | 203 | 468 |
| 4.w. | Reptiles |  |  |  |  |  | 0 |
| 4.x. | Amphibians | 15 | 36 | 0 | 590 | 0 | 641 |
| 4.y. | Fish | 0 | 0 | 0 | 0 | 1676 | 1676 |
| 4.z. | TOTAL | 36111 | 55416 | 31357 | 109795 | 8291 | 240970 |

  

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 | | |  |  |  | |  | 140 | 516 | 656 |
| 5.b. | Rats | | |  |  |  | |  |  | 10 | 10 |
| 5.c. | Guinea-Pigs | | |  |  |  | |  |  | 26 | 26 |
| 5.d. | Hamsters | | |  |  |  | |  |  |  | 0 |
| 5.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 5.f. | Rabbits | | |  |  |  | |  |  | 12 | 12 |
| 5.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 5.h. | Dogs | | |  |  |  | |  |  |  | 0 |
| 5.i. | Ferrets | | |  |  |  | |  |  |  | 0 |
| 5.j. | Other Carnivores | | |  |  |  | |  |  |  | 0 |
| 5.k. | Horses, donkeys and cross breds | | |  |  |  | |  |  | 8 | 8 |
| 5.l. | Pigs | | |  |  |  | |  |  |  | 0 |
| 5.m. | Goats | | |  |  |  | |  |  |  | 0 |
| 5.n. | Sheep | | |  |  |  | |  |  | 12 | 12 |
| 5.o. | Cattle | | |  |  |  | |  |  | 3 | 3 |
| 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 | | |  |  |  | |  |  | 103 | 103 |
| 5.w. | Reptiles | | |  |  |  | |  |  |  | 0 |
| 5.x. | Amphibians | | |  |  |  | |  |  |  | 0 |
| 5.y. | Fish | | |  |  |  | |  |  |  | 0 |
| 5.z. | TOTAL | | | 0 | 0 | 0 | | 0 | 140 | 690 | 830 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 1620 |  |  | |  | 636 | 49 | 2305 |
| 6.b. | Rats | | |  |  |  | |  | 5225 |  | 5225 |
| 6.c. | Guinea-Pigs | | |  |  |  | |  |  |  | 0 |
| 6.d. | Hamsters | | |  |  |  | |  |  | 135 | 135 |
| 6.e. | Other Rodents | | |  |  |  | |  |  |  | 0 |
| 6.f. | Rabbits | | |  |  |  | |  |  | 371 | 371 |
| 6.g. | Cats | | |  |  |  | |  |  |  | 0 |
| 6.h. | Dogs | | |  |  |  | |  | 546 |  | 546 |
| 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 | | | 870 |  |  | |  |  | 500 | 1370 |
| 6.z. | TOTAL | | | 2490 | 0 | 0 | | 0 | 6407 | 1055 | 9952 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. |  |  | 1620 |  |  |  |  |  |  |  | 170 |  |  | 515 | 2305 |
| 7.b. | Rats |  |  | 2399 |  |  |  |  |  | 132 | 655 | 206 |  | 1833 | 5225 |
| 7.c. | Guinea-Pigs |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.d. | Hamsters |  |  | 135 |  |  |  |  |  |  |  |  |  |  | 135 |
| 7.e. | Other Rodents |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.f. | Rabbits |  |  | 34 |  |  |  |  |  | 337 |  |  |  |  | 371 |
| 7.g. | Cats |  |  |  |  |  |  |  |  |  |  |  |  |  | 0 |
| 7.h. | Dogs |  |  | 486 |  |  |  |  |  |  |  |  |  | 60 | 546 |
| 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 |  |  |  |  |  |  |  |  |  |  | 1180 | 190 |  | 1370 |
| 7.z. | TOTAL | 0 | 1620 | 3054 | 0 | 0 | 0 | 0 | 0 | 469 | 825 | 1386 | 190 | 2408 | 9952 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine |  |  | 3054 |  |  |  |  |  | 469 | 825 | 206 |  | 2359 | 6913 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture |  |  |  |  |  |  |  |  |  |  | 250 |  |  | 250 |
| 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 |  | 1620 |  |  |  |  |  |  |  |  |  |  |  | 1620 |
| 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 |  |  |  |  |  |  |  |  |  |  | 870 | 190 | 49 | 1109 |
| 8.i. | Other toxicological or safety evaluations |  |  |  |  |  |  |  |  |  |  | 60 |  |  | 60 |
| 8.j. | TOTAL | 0 | 1620 | 3054 | 0 | 0 | 0 | 0 | 0 | 469 | 825 | 1386 | 190 | 2408 | 9952 |

UNITED KINGDOM

Statistical data submitted

The United Kingdom statistical data for 2008 were prepared, quality assured and submitted by the "Home Office".

Within the United Kingdom (UK), Great Britain (GB) and Northern Ireland (NI) publish separate, annual statistical reports based largely on the number of procedures started rather than numbers of animals used.

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

Comments of United Kingdom authorities

In the UK, just over 2.26 million animals were used for the first time in procedures started in 2008, a rise of 393,000 (+21%) on the number reported for 2005. The increase was largely accounted for by increases in numbers of fish (+292,000) and mice (+160,000) along with a fall in the use of rats (-68,000).

2,039,577 (90%) of the animals used were mice (53%), rats (15%) or fish (21%).

Cold-blooded animals (fish, amphibia, and reptiles) accounted for 507,470 (22%) of the animals used.

Cats, dogs, equidae and non-human primates are accorded special protection in the UK and collectively amounted to 8,105 animals, 0,4% of the animals used – a reduction of 999 compared with 2005.

Non-human primates accounted for 3,354 animals, 0,15% of animals used, very slightly less as a percentage but 239 more as an absolute number than in 2005. (although there was a fall in the numbers of new world monkeys used, there was a larger rise in the number of old world monkeys used)

1,172,936, animals (52%) were used for fundamental biological studies, research and development and production and quality control relating to human medicine, dentistry and veterinary medicine.

Toxicological or other safety evaluation used 284,888 animals (13%) – an increase of 36,278 since 2005.

There was a marked increase in the number of toxicology and other safety evaluation experiments carried out in 2008 not to satisfy any regulatory requirements (94,185), up 65,117 compared with 2005 (29,068) in 2005, largely due to an increases in such use of fish (+80,098).

176,362 animals (8%) were used for the production and quality control of products and devices for human medicine, dentistry or veterinary medicine – almost 66,000 more than in 2005. This increase was accounted for almost entirely by an increase in the number of mice (+48,000) and fish (+17,000).

Approximately 40% of animals used received some form of anaesthesia, hardly changed from 2005. For the other animals the use of anaesthesia would have been deemed to increase the severity of the procedure.

As in 2005 no animals were used in 2008 to evaluate the safety of either cosmetic products or cosmetic ingredients.

No animals were used in 2008 for monoclonal antibody production using the ascites method.

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) | 1212243 | 1.206.713 | 1.809 | 173 | 3.548 |  |
| 1.b. | Rats (Rattus norvegicus) | 343289 | 341.897 | 785 | 105 | 502 |  |
| 1.c. | Guinea-Pigs (Cavia porcellus) | 29250 | 28.762 | 488 | 0 | 0 |  |
| 1.d. | Hamsters (Mesocricetus ) | 2851 | 1.247 | 1.604 | 0 | 0 |  |
| 1.e. | Other Rodents (other Rodentia) | 1.958 |  |  |  |  |  |
| 1.f. | Rabbits (Oryctolagus cuniculus) | 12009 | 9.297 | 2.140 | 0 | 572 | 3.066 |
| 1.g. | Cats (Felis catus) | 184 | 79 | 52 | 0 | 53 | 147 |
| 1.h. | Dogs (Canis familiaris) | 4277 | 3.458 | 58 | 0 | 761 | 896 |
| 1.i. | Ferrets (Mustela putorius furo) | 978 | 973 | 0 | 0 | 5 | 44 |
| 1.j. | Other Carnivores (other Carnivora) | 948 |  |  |  |  |  |
| 1.k. | Horses, donkeys and cross breds (Equidae) | 290 |  |  |  |  |  |
| 1.l. | Pigs (Sus) | 7.255 |  |  |  |  |  |
| 1.m. | Goats (Capra) | 487 |  |  |  |  |  |
| 1.n. | Sheep (Ovis) | 9.818 |  |  |  |  |  |
| 1.o. | Cattle (Bos) | 4.194 |  |  |  |  |  |
| 1.p. | Prosimians (Prosimia) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.q. | New World Monkeys (Ceboidea) | 262 | 262 | 0 | 0 | 0 | 82 |
| 1.r. | Old World Monkeys (Cercopithecoidea) | 3092 | 1.814 | 96 | 0 | 1.182 | 497 |
| 1.s. | Apes (Hominoidea) | 0 | 0 | 0 | 0 | 0 | 0 |
| 1.t. | Other Mammals(other Mammalia) | 952 |  |  |  |  |  |
| 1.u. | Quail (Coturnix coturnix) | 0 | 0 | 0 | 0 | 0 |  |
| 1.v. | Other birds (other Aves) | 125.077 |  |  |  |  |  |
| 1.w. | Reptiles (Reptilia) | 109 |  |  |  |  |  |
| 1.x. | Amphibians (Amphibia) | 23.316 |  |  |  |  |  |
| 1.y. | Fish (Pisces) | 484.045 |  |  |  |  |  |
| 1.z. | TOTAL | 2266884 |  |  |  |  |  |

Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.

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

Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2

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

Purpose versus species

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2.1  Species | | 2.2  Biological studies of a fundamental nature | 2.3  Research and development of products and devices for human medicine and dentistry and for veterinary medicine  (excluding toxicological and other safety evaluations counted in column 2.6) | 2.4  Production and quality control of products and devices for human medicine and dentistry | 2.5  Production and quality control of products and devices for veterinary medicine | 2.6  Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) | 2.7  Diagnosis of disease | 2.8  Education and training | 2.9  Other | 2.10  Total |
| 2.a. | Mice | 374.109 | 88.038 | 115.790 | 13.721 | 56.951 | 13.683 | 829 | 549.122 | 1212243 |
| 2.b. | Rats | 92.466 | 115.862 | 7.135 | 0 | 100.777 | 419 | 1.386 | 25.244 | 343289 |
| 2.c. | Guinea-Pigs | 1.753 | 17.474 | 4.784 | 492 | 1.911 | 168 | 115 | 2.553 | 29250 |
| 2.d. | Hamsters | 828 | 31 | 0 | 576 | 873 | 0 | 0 | 543 | 2851 |
| 2.e. | Other Rodents | 931 | 512 | 30 | 0 | 191 | 0 | 0 | 294 | 1958 |
| 2.f. | Rabbits | 996 | 611 | 427 | 230 | 7.431 | 1.018 | 12 | 1.284 | 12009 |
| 2.g. | Cats | 61 | 41 | 0 | 0 | 53 | 0 | 0 | 29 | 184 |
| 2.h. | Dogs | 4 | 381 | 139 | 0 | 3.662 | 11 | 0 | 80 | 4277 |
| 2.i. | Ferrets | 319 | 6 | 556 | 6 | 0 | 41 | 12 | 38 | 978 |
| 2.j. | Other Carnivores | 507 | 0 | 0 | 27 | 296 | 0 | 0 | 118 | 948 |
| 2.k. | Horses, donkeys and cross breds | 54 | 44 | 0 | 21 | 22 | 19 | 0 | 130 | 290 |
| 2.l. | Pigs | 1.652 | 403 | 24 | 948 | 728 | 0 | 0 | 3.500 | 7255 |
| 2.m. | Goats | 65 | 0 | 1 | 4 | 10 | 12 | 0 | 395 | 487 |
| 2.n. | Sheep | 5.120 | 52 | 491 | 253 | 100 | 985 | 0 | 2.817 | 9818 |
| 2.o. | Cattle | 2.808 | 152 | 0 | 804 | 195 | 4 | 0 | 231 | 4194 |
| 2.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.q. | New World Monkeys | 82 | 4 | 33 | 0 | 123 | 0 | 0 | 20 | 262 |
| 2.r. | Old World Monkeys | 122 | 181 | 12 | 0 | 2.733 | 0 | 0 | 44 | 3092 |
| 2.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.t. | Other Mammals | 825 | 0 | 0 | 0 | 0 | 0 | 0 | 127 | 952 |
| 2.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2.v. | Other birds | 22.221 | 201 | 16 | 6.472 | 1.783 | 2.168 | 154 | 92.062 | 125077 |
| 2.w. | Reptiles | 30 | 0 | 0 | 0 | 0 | 0 | 0 | 79 | 109 |
| 2.x. | Amphibians | 8.993 | 0 | 0 | 0 | 0 | 0 | 0 | 14.323 | 23316 |
| 2.y. | Fish | 230.664 | 54.477 | 20.418 | 2.952 | 107.049 | 0 | 117 | 68.368 | 484045 |
| 2.z. | TOTAL | 744610 | 278470 | 149856 | 26506 | 284888 | 18528 | 2625 | 761401 | 2266884 |

  

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

Products versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3.1  Species | | 3.2  Products/ substances or devices for human  medicine and dentistry and for veterinary medicine | 3.3  Products/ substances used or intended to be used mainly in agriculture | 3.4  Products/ substances used or intended to be used mainly in industry | 3.5  Products/ substances used or intended to be used mainly in the household | 3.6  Products/ substances used or intended to be used mainly as cosmetics or toiletries | 3.7  Products/ substances used or intended to be used mainly as additives in food for human consumption | 3.8  Products/ substances used or intended to be used mainly as additives in food for animal consumption | 3.9  Potential or actual contami- nants in the general envi- ronment which do not appear in other columns | 3.10  Other toxico- logical or safety evaluations | 3.11  Total |
| 3.a. | Mice | 38.288 | 1.803 | 5.351 | 132 | 0 | 0 | 0 | 78 | 11.299 | 56951 |
| 3.b. | Rats | 73.139 | 11.131 | 10.533 | 0 | 0 | 0 | 0 | 5 | 5.969 | 100777 |
| 3.c. | Guinea-Pigs | 1.822 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 89 | 1911 |
| 3.d. | Hamsters | 873 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 873 |
| 3.e. | Other Rodents | 0 | 164 | 0 | 0 | 0 | 0 | 0 | 0 | 27 | 191 |
| 3.f. | Rabbits | 5.658 | 330 | 1.241 | 0 | 0 | 0 | 0 | 0 | 202 | 7431 |
| 3.g. | Cats | 53 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 53 |
| 3.h. | Dogs | 3.323 | 116 | 8 | 0 | 0 | 0 | 0 | 0 | 215 | 3662 |
| 3.i. | Ferrets | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.j. | Other Carnivores | 296 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 296 |
| 3.k. | Horses, donkeys and cross breds | 22 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 22 |
| 3.l. | Pigs | 600 | 62 | 0 | 0 | 0 | 0 | 0 | 0 | 66 | 728 |
| 3.m. | Goats | 0 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 |
| 3.n. | Sheep | 99 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 100 |
| 3.o. | Cattle | 195 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 195 |
| 3.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 3.q. | New World Monkeys | 53 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 70 | 123 |
| 3.r. | Old World Monkeys | 2.358 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 375 | 2733 |
| 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 | 706 | 1.041 | 30 | 0 | 0 | 0 | 0 | 0 | 6 | 1783 |
| 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 | 62.571 | 2.464 | 6.349 | 0 | 0 | 0 | 0 | 10.146 | 25.519 | 107049 |
| 3.z. | TOTAL | 190056 | 17121 | 23512 | 132 | 0 | 0 | 0 | 10229 | 43838 | 284888 |

  

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

Main categories versus species

|  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1  Species | | 4.2  Human cardiovascular diseases | 4.3  Human nervous and mental disorders | 4.4  Human cancer (excluding evaluations of carcinogenic hazards or risks) | 4.5  Other human diseases | 4.6  Studies specific to animal diseases | 4.7  Total |
| 4.a. | Mice | 25.167 | 85.363 | 101.726 | 500.412 | 17.182 | 729850 |
| 4.b. | Rats | 16.152 | 95.146 | 2.713 | 189.881 | 75 | 303967 |
| 4.c. | Guinea-Pigs | 675 | 707 | 0 | 26.420 | 1.333 | 29135 |
| 4.d. | Hamsters | 67 | 762 | 0 | 1.438 | 584 | 2851 |
| 4.e. | Other Rodents | 162 | 766 | 155 | 625 | 27 | 1735 |
| 4.f. | Rabbits | 656 | 216 | 0 | 8.292 | 1.201 | 10365 |
| 4.g. | Cats | 10 | 43 | 0 | 8 | 123 | 184 |
| 4.h. | Dogs | 254 | 0 | 2 | 3.613 | 91 | 3960 |
| 4.i. | Ferrets | 20 | 125 | 0 | 815 | 6 | 966 |
| 4.j. | Other Carnivores | 45 | 0 | 0 | 462 | 326 | 833 |
| 4.k. | Horses, donkeys and cross breds | 3 | 0 | 0 | 74 | 213 | 290 |
| 4.l. | Pigs | 161 | 143 | 0 | 2.523 | 4.289 | 7116 |
| 4.m. | Goats | 0 | 0 | 0 | 78 | 399 | 477 |
| 4.n. | Sheep | 77 | 455 | 0 | 6.608 | 2.342 | 9482 |
| 4.o. | Cattle | 226 | 15 | 0 | 2.571 | 1.379 | 4191 |
| 4.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.q. | New World Monkeys | 2 | 46 | 0 | 214 | 0 | 262 |
| 4.r. | Old World Monkeys | 75 | 158 | 0 | 2.519 | 0 | 2752 |
| 4.s. | Apes | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.t. | Other Mammals | 10 | 5 | 0 | 810 | 0 | 825 |
| 4.u. | Quail | 0 | 0 | 0 | 0 | 0 | 0 |
| 4.v. | Other birds | 4.573 | 2.595 | 0 | 17.237 | 98.894 | 123299 |
| 4.w. | Reptiles | 0 | 30 | 0 | 0 | 0 | 30 |
| 4.x. | Amphibians | 96 | 33 | 351 | 8.513 | 0 | 8993 |
| 4.y. | Fish | 119 | 47.743 | 3 | 351.819 | 8.674 | 408358 |
| 4.z. | TOTAL | 48550 | 234351 | 104950 | 1124932 | 137138 | 1649921 |

  

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 | | | 218 | 6161 | 0 | | 158 | 116191 | 6783 | 129511 |
| 5.b. | Rats | | | 0 | 1440 | 0 | | 0 | 5288 | 407 | 7135 |
| 5.c. | Guinea-Pigs | | | 321 | 1432 | 0 | | 156 | 3347 | 20 | 5276 |
| 5.d. | Hamsters | | | 0 | 576 | 0 | | 0 | 0 | 0 | 576 |
| 5.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 30 | 0 | 30 |
| 5.f. | Rabbits | | | 9 | 132 | 0 | | 0 | 516 | 0 | 657 |
| 5.g. | Cats | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.h. | Dogs | | | 0 | 0 | 0 | | 0 | 137 | 2 | 139 |
| 5.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 514 | 48 | 562 |
| 5.j. | Other Carnivores | | | 27 | 0 | 0 | | 0 | 0 | 0 | 27 |
| 5.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 21 | 0 | 21 |
| 5.l. | Pigs | | | 0 | 337 | 0 | | 0 | 635 | 0 | 972 |
| 5.m. | Goats | | | 0 | 0 | 0 | | 0 | 5 | 0 | 5 |
| 5.n. | Sheep | | | 14 | 121 | 0 | | 0 | 608 | 1 | 744 |
| 5.o. | Cattle | | | 0 | 726 | 0 | | 0 | 55 | 23 | 804 |
| 5.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 33 | 0 | 33 |
| 5.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 12 | 0 | 12 |
| 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 | | | 0 | 206 | 0 | | 0 | 6282 | 0 | 6488 |
| 5.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 5.y. | Fish | | | 0 | 1390 | 0 | | 0 | 58 | 21922 | 23370 |
| 5.z. | TOTAL | | | 589 | 12521 | 0 | | 314 | 133732 | 29206 | 176362 |
| Examples: | | 5.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 5.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 5.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 5.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 5.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Regulatory requirements versus species

|  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1  Species | | | | 6.2  National legislation specific to a single EC Member State  1) | 6.3  EC legislation including European Pharmacopoeia  (requirements) | 6.4  Member Country of Council of Europe (but not EC) legislation  2) | | 6.5  Other legislation | 6.6  Any combination of  6.2/ 6.3/ 6.4/ 6.5 | 6.7  No regulatory requirements | 6.8  Total |
| 6.a. | Mice | | | 37 | 9718 | 0 | | 1714 | 42538 | 2944 | 56951 |
| 6.b. | Rats | | | 97 | 2510 | 0 | | 617 | 92799 | 4754 | 100777 |
| 6.c. | Guinea-Pigs | | | 0 | 272 | 0 | | 30 | 1504 | 105 | 1911 |
| 6.d. | Hamsters | | | 0 | 0 | 0 | | 0 | 873 | 0 | 873 |
| 6.e. | Other Rodents | | | 0 | 0 | 0 | | 0 | 191 | 0 | 191 |
| 6.f. | Rabbits | | | 18 | 1955 | 0 | | 121 | 5191 | 146 | 7431 |
| 6.g. | Cats | | | 0 | 12 | 0 | | 0 | 41 | 0 | 53 |
| 6.h. | Dogs | | | 0 | 0 | 0 | | 40 | 3506 | 116 | 3662 |
| 6.i. | Ferrets | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.j. | Other Carnivores | | | 296 | 0 | 0 | | 0 | 0 | 0 | 296 |
| 6.k. | Horses, donkeys and cross breds | | | 0 | 0 | 0 | | 0 | 1 | 21 | 22 |
| 6.l. | Pigs | | | 0 | 123 | 0 | | 32 | 509 | 64 | 728 |
| 6.m. | Goats | | | 0 | 0 | 0 | | 0 | 10 | 0 | 10 |
| 6.n. | Sheep | | | 2 | 24 | 0 | | 0 | 73 | 1 | 100 |
| 6.o. | Cattle | | | 10 | 70 | 0 | | 0 | 115 | 0 | 195 |
| 6.p. | Prosimians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.q. | New World Monkeys | | | 0 | 0 | 0 | | 0 | 99 | 24 | 123 |
| 6.r. | Old World Monkeys | | | 0 | 0 | 0 | | 0 | 2643 | 90 | 2733 |
| 6.s. | Apes | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.t. | Other Mammals | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.u. | Quail | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.v. | Other birds | | | 0 | 272 | 0 | | 0 | 1505 | 6 | 1783 |
| 6.w. | Reptiles | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.x. | Amphibians | | | 0 | 0 | 0 | | 0 | 0 | 0 | 0 |
| 6.y. | Fish | | | 1311 | 9074 | 0 | | 1451 | 9299 | 85914 | 107049 |
| 6.z. | TOTAL | | | 1771 | 24030 | 0 | | 4005 | 160897 | 94185 | 284888 |
| Examples: | | 6.2 – France is testing due to a UK (or FR) specific requirement | | | | Note: | columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and | | | | | |
|  | | 6.3 - UK is testing according to EC legislation | | | |  | not to the body which has issued the actual test method, guideline or protocol. | | | | | |
|  | | 6.4 – Spain is testing due to a Norwegian requirement | | | | Example: | a test required by French legislation and carried out in Belgium according to an | | | | | |
|  | | 6.5 – Poland is testing due to a US specific requirement | | | |  | ISO protocol must be coded as a national (FR) legislative requirement and be | | | | | |
|  | | 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) | | | |  | entered into column 6.2 in the tables submitted by Belgium. | | | | | |
| Footnotes: | | 1) | EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom | | | | | | | | | |
|  | | 2) | Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine | | | | | | | | | |

  

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

Types of tests versus species

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1  Species | | 7.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 7.3  Skin irritation | 7.4  Skin sensitisation | 7.5  Eye irritation | 7.6  Sub- chronic and chronic toxicity | 7.7  Carcino- genicity | 7.8  Develop- mental toxicity | 7.9  Muta- genicity | 7.10  Repro-ductive toxicity | 7.11  Toxicity to aquatic vertebra-tes not included in other columns | 7.12  Other | 7.13  Total |
|  |  | 7.2.1.  LD50, LC50 | 7.2.2  Other lethal methods | 7.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 7.a. | Mice | 917 | 8.832 | 5.962 | 12 | 1.074 | 0 | 3.344 | 5.659 | 544 | 2.923 | 0 | 0 | 27.684 | 56951 |
| 7.b. | Rats | 1.674 | 2.042 | 30.143 | 0 | 0 | 0 | 7.834 | 3.478 | 3.943 | 5.353 | 29.488 | 0 | 16.822 | 100777 |
| 7.c. | Guinea-Pigs | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.909 | 1911 |
| 7.d. | Hamsters | 0 | 0 | 208 | 0 | 0 | 0 | 80 | 0 | 0 | 0 | 0 | 0 | 585 | 873 |
| 7.e. | Other Rodents | 27 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 164 | 191 |
| 7.f. | Rabbits | 0 | 0 | 490 | 740 | 0 | 479 | 0 | 0 | 3.635 | 0 | 86 | 0 | 2.001 | 7431 |
| 7.g. | Cats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 53 | 53 |
| 7.h. | Dogs | 0 | 0 | 2.020 | 0 | 0 | 0 | 1.167 | 0 | 0 | 0 | 2 | 0 | 473 | 3662 |
| 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 | 296 | 296 |
| 7.k. | Horses, donkeys and cross breds | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 22 | 22 |
| 7.l. | Pigs | 0 | 0 | 293 | 0 | 0 | 0 | 68 | 0 | 0 | 0 | 0 | 0 | 367 | 728 |
| 7.m. | Goats | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 10 |
| 7.n. | Sheep | 0 | 0 | 36 | 0 | 0 | 0 | 34 | 0 | 0 | 0 | 0 | 0 | 30 | 100 |
| 7.o. | Cattle | 0 | 0 | 44 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 151 | 195 |
| 7.p. | Prosimians | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 7.q. | New World Monkeys | 0 | 0 | 29 | 0 | 0 | 0 | 24 | 0 | 0 | 0 | 0 | 0 | 70 | 123 |
| 7.r. | Old World Monkeys | 0 | 0 | 1.414 | 0 | 0 | 0 | 720 | 0 | 0 | 0 | 0 | 0 | 599 | 2733 |
| 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 | 180 | 135 | 651 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 108 | 0 | 709 | 1783 |
| 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 | 5.903 | 61.278 | 3.398 | 0 | 0 | 0 | 7.530 | 0 | 364 | 0 | 1.589 | 0 | 26.987 | 107049 |
| 7.z. | TOTAL | 8701 | 72287 | 44690 | 752 | 1074 | 479 | 20801 | 9137 | 8486 | 8276 | 31273 | 0 | 78932 | 284888 |

  

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

Types of tests versus products

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1  Products | | 8.2  Acute and sub-acute toxicity testing methods (including limit test) | | | 8.3  Skin irritation | 8.4  Skin sensitisation | 8.5  Eye irritation | 8.6  Sub- chronic and chronic toxicity | 8.7  Carcino genicity | 8.8  Develop- mental toxicity | 8.9  Muta- genicity | 8.10  Repro-ductive toxicity | 8.11  Toxicity to aquatic vertebra-tes not included in other columns | 8.12  Other | 8.13  Total |
|  |  | 8.2.1.  LD50, LC50 | 8.2.2  Other lethal methods | 8.2.3  Non lethal clinical signs methods |  |  |  |  |  |  |  |  |  |  |  |
| 8.a. | Products/substances or devices for human medicine and dentistry and for veterinary medicine | 72 | 59231 | 37822 | 51 | 556 | 9 | 12862 | 8229 | 7550 | 4867 | 19293 | 0 | 39514 | 190056 |
| 8.b. | Products/substances used or intended to be used mainly in agriculture | 846 | 1067 | 1440 | 57 | 16 | 56 | 2531 | 908 | 332 | 701 | 6446 | 0 | 2721 | 17121 |
| 8.c. | Products/substances used or intended to be used mainly in industry | 1331 | 1806 | 4127 | 641 | 314 | 411 | 5232 | 0 | 604 | 1403 | 3794 | 0 | 3849 | 23512 |
| 8.d. | Products/substances used or intended to be used mainly in the household | 0 | 0 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 114 | 0 | 0 | 0 | 132 |
| 8.e. | Products/substances used or intended to be used mainly as cosmetics or toiletries | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.f. | Products/substances used or intended to be used mainly as additives in food for human consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.g. | Products/substances used or intended to be used mainly as additives in food for animal consumption | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 8.h. | Potential or actual contaminants in the general environment which do not appear in other columns | 4184 | 2633 | 942 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1589 | 0 | 881 | 10229 |
| 8.i. | Other toxicological or safety evaluations | 2268 | 7550 | 341 | 3 | 188 | 3 | 176 | 0 | 0 | 1191 | 151 | 0 | 31967 | 43838 |
| 8.j. | TOTAL | 8701 | 72287 | 44690 | 752 | 1074 | 479 | 20801 | 9137 | 8486 | 8276 | 31273 | 0 | 78932 | 284888 |

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