Source: EURLEX
Language: en
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*|*

# 52013SC0497R(01)

**COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union /\* SWD/2013/0497 final/2 \*/**

  

COMMISSION STAFF WORKING DOCUMENT

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

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

TABLE OF CONTENTS

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

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

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

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

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

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

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

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

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

FRANCE

Statistical data submitted

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

Comments of the French authorities

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

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

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

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

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

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

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

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

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) || 1 326 274 || 1 193 758 || 20 682 || 39 110 || 72 724 || 914

1.b. || Rats (Rattus norvegicus) || 252 589 || 244 910 || 674 || 1 030 || 5 975 || 2 132

1.c. || Guinea-Pigs (Cavia porcellus) || 35 543 || 31 181 || 3 857 || 410 || 95 || 0

1.d. || Hamsters (Mesocricetus ) || 8 210 || 6 805 || 243 || 0 || 1 162 || 0

1.e. || Other Rodents (other Rodentia) || 224 || 0 || 0 || 0 || 0 || 0

1.f. || Rabbits (Oryctolagus cuniculus) || 125 913 || 125 912 || 0 || 1 || 0 || 1 102

1.g. || Cats (Felis catus) || 569 || 479 || 69 || 0 || 21 || 130

1.h. || Dogs (Canis familiaris) || 3 032 || 1 840 || 373 || 129 || 690 || 825

1.i. || Ferrets (Mustela putorius furo) || 351 || 0 || 0 || 0 || 351 || 72

1.j. || Other Carnivores (other Carnivora) || 0 || 0 || 0 || 0 || 0 || 0

1.k. || Horses, donkeys and cross breds (Equidae) || 373 || 0 || 0 || 0 || 0 || 0

1.l. || Pigs (Sus) || 7 364 || 0 || 0 || 0 || 0 || 0

1.m. || Goats (Capra) || 710 || 0 || 0 || 0 || 0 || 0

1.n. || Sheep (Ovis) || 5 491 || 0 || 0 || 0 || 0 || 0

1.o. || Cattle (Bos) || 2 362 || 0 || 0 || 0 || 0 || 0

1.p. || Prosimians (Prosimia) || 83 || 83 || 0 || 0 || 0 || 83

1.q. || New World Monkeys (Ceboidea) || 163 || 160 || 3 || 0 || 0 || 156

1.r. || Old World Monkeys (Cercopithecoidea) || 1 564 || 666 || 63 || 0 || 835 || 514

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t. || Other Mammals (other Mammalia) || 2 || 0 || 0 || 0 || 0 || 0

1.u. || Quail (Coturnix coturnix) || 122 || 122 || 0 || 0 || 0 || 0

1.v. || Other birds (other Aves) || 71 821 || 0 || 0 || 0 || 0 || 0

1.w. || Reptiles (Reptilia) || 74 || 0 || 0 || 0 || 0 || 0

1.x. || Amphibians (Amphibia) || 3 279 || 0 || 0 || 0 || 0 || 0

1.y. || Fish (Pisces) || 354 039 || || || || ||

1.z. || TOTAL || 2 200 152 || 1 605 916 || 25 964 || 40 680 || 81 853 || 5 928

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

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

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

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 || 547 843 || 347 485 || 312 483 || 13 527 || 22 074 || 2 879 || 10 722 || 69 261 || 1 326 274

2.b. || Rats || 45 681 || 130 052 || 3 638 || 163 || 41 799 || 152 || 10 105 || 20 999 || 252 589

2.c. || Guinea-Pigs || 464 || 4 816 || 25 829 || 750 || 2 609 || 0 || 75 || 1 000 || 35 543

2.d. || Hamsters || 567 || 3 361 || 0 || 1 416 || 542 || 0 || 80 || 2 244 || 8 210

2.e. || Other Rodents || 118 || 100 || 0 || 0 || 0 || 0 || 6 || 0 || 224

2.f. || Rabbits || 1 343 || 6 922 || 53 613 || 1 015 || 3 733 || 8 || 424 || 58 855 || 125 913

2.g. || Cats || 40 || 317 || 0 || 132 || 68 || 0 || 0 || 12 || 569

2.h. || Dogs || 125 || 1 012 || 0 || 375 || 1 483 || 0 || 6 || 31 || 3 032

2.i. || Ferrets || 36 || 288 || 4 || 0 || 20 || 0 || 3 || 0 || 351

2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.k. || Horses, donkeys and cross breds || 3 || 96 || 94 || 5 || 0 || 0 || 10 || 165 || 373

2.l. || Pigs || 136 || 1 759 || 0 || 681 || 245 || 4 || 1 951 || 2 588 || 7 364

2.m. || Goats || 78 || 35 || 0 || 0 || 0 || 7 || 0 || 590 || 710

2.n. || Sheep || 18 || 510 || 10 || 808 || 161 || 0 || 5 || 3 979 || 5 491

2.o. || Cattle || 3 || 443 || 0 || 108 || 239 || 0 || 19 || 1 550 || 2 362

2.p. || Prosimians || 83 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 83

2.q. || New World Monkeys || 31 || 125 || 0 || 0 || 6 || 0 || 0 || 1 || 163

2.r. || Old World Monkeys || 110 || 484 || 86 || 0 || 811 || 0 || 0 || 73 || 1 564

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2

2.u. || Quail || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 122

2.v. || Other birds || 294 || 3 818 || 7 669 || 38 277 || 45 || 0 || 58 || 21 660 || 71 821

2.w. || Reptiles || 74 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 74

2.x. || Amphibians || 1 016 || 12 || 0 || 0 || 0 || 0 || 2 238 || 13 || 3 279

2.y. || Fish || 345 || 3 047 || 0 || 0 || 4 206 || 0 || 418 || 346 023 || 354 039

2.z. || TOTAL || 598 532 || 504 682 || 403 426 || 57 257 || 78 041 || 3 050 || 26 120 || 529 044 || 2 200 152

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 || 9 604 || 3 122 || 1 765 || 0 || 0 || 52 || 0 || 872 || 6 659 || 22 074

3.b. || Rats || 15 019 || 5 979 || 4 235 || 0 || 40 || 70 || 54 || 756 || 15 646 || 41 799

3.c. || Guinea-Pigs || 914 || 750 || 150 || 0 || 0 || 0 || 0 || 0 || 795 || 2 609

3.d. || Hamsters || 254 || 73 || 21 || 0 || 0 || 0 || 0 || 0 || 194 || 542

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 1 043 || 397 || 212 || 0 || 0 || 0 || 0 || 0 || 2 081 || 3 733

3.g. || Cats || 68 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 68

3.h. || Dogs || 693 || 88 || 0 || 0 || 0 || 0 || 0 || 0 || 702 || 1 483

3.i. || Ferrets || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20

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 || 112 || 0 || 0 || 0 || 0 || 0 || 0 || 3 || 130 || 245

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 21 || 140 || 0 || 161

3.o. || Cattle || 233 || 0 || 0 || 0 || 0 || 0 || 6 || 0 || 0 || 239

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 || 6 || 6

3.r. || Old World Monkeys || 242 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 569 || 811

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 || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 45

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 || 86 || 2 049 || 0 || 0 || 0 || 0 || 0 || 0 || 2 071 || 4 206

3.z. || TOTAL || 28 333 || 12 458 || 6 383 || 0 || 40 || 122 || 81 || 1 771 || 28 853 || 78 041

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 || 94 767 || 142 675 || 178 443 || 261 176 || 221 146 || 898 207

4.b. || Rats || 38 018 || 78 662 || 4 392 || 53 274 || 1 539 || 175 885

4.c. || Guinea-Pigs || 652 || 281 || 26 || 4 028 || 293 || 5 280

4.d. || Hamsters || 506 || 0 || 72 || 1 109 || 2 241 || 3 928

4.e. || Other Rodents || 0 || 0 || 0 || 80 || 138 || 218

4.f. || Rabbits || 1 438 || 184 || 79 || 6 483 || 89 || 8 273

4.g. || Cats || 0 || 19 || 0 || 44 || 294 || 357

4.h. || Dogs || 68 || 41 || 1 || 286 || 741 || 1 137

4.i. || Ferrets || 0 || 0 || 0 || 273 || 51 || 324

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 99 || 99

4.l. || Pigs || 544 || 29 || 0 || 549 || 777 || 1 899

4.m. || Goats || 0 || 0 || 0 || 31 || 89 || 120

4.n. || Sheep || 170 || 0 || 0 || 69 || 289 || 528

4.o. || Cattle || 4 || 0 || 0 || 3 || 439 || 446

4.p. || Prosimians || 0 || 58 || 0 || 25 || 0 || 83

4.q. || New World Monkeys || 0 || 0 || 0 || 156 || 0 || 156

4.r. || Old World Monkeys || 343 || 12 || 0 || 194 || 45 || 594

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 2 || 0 || 0 || 2

4.u. || Quail || 0 || 0 || 0 || 122 || 0 || 122

4.v. || Other birds || 0 || 0 || 0 || 299 || 3 813 || 4 112

4.w. || Reptiles || 0 || 0 || 0 || 24 || 50 || 74

4.x. || Amphibians || 36 || 40 || 0 || 67 || 885 || 1 028

4.y. || Fish || 0 || 0 || 0 || 3 127 || 265 || 3 392

4.z. || TOTAL || 136 546 || 222 001 || 183 015 || 331 419 || 233 283 || 1 106 264

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 || 24 926 || 49 841 || 2 162 || 0 || 223 452 || 25 629 || 326 010 ||

5.b. || Rats || 3 282 || 243 || 0 || 0 || 274 || 2 || 3 801 ||

5.c. || Guinea-Pigs || 0 || 3 064 || 0 || 280 || 23 235 || 0 || 26 579 ||

5.d. || Hamsters || 0 || 1 416 || 0 || 0 || 0 || 0 || 1 416 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 488 || 27 006 || 0 || 0 || 2 338 || 24 796 || 54 628 ||

5.g. || Cats || 0 || 132 || 0 || 0 || 0 || 0 || 132 ||

5.h. || Dogs || 118 || 257 || 0 || 0 || 0 || 0 || 375 ||

5.i. || Ferrets || 0 || 0 || 0 || , || 4 || 0 || 4 ||

5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.k. || Horses, donkeys and cross breds || 0 || 99 || 0 || 0 || 0 || 0 || 99 ||

5.l. || Pigs || 0 || 681 || 0 || 0 || 0 || 0 || 681 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 818 || 0 || 0 || 0 || 0 || 818 ||

5.o. || Cattle || 0 || 108 || 0 || 0 || 0 || 0 || 108 ||

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 || 86 || 0 || 86 ||

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 || 45 916 || 0 || 0 || 0 || 30 || 45 946 ||

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 || 28 814 || 129 581 || 2 162 || 280 || 249 389 || 50 457 || 460 683 ||

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 || 7 193 || 3 680 || 0 || 4 092 || 5 029 || 2 080 || 22 074 ||

6.b. || Rats || 10 268 || 3 372 || 162 || 9 058 || 16 064 || 2 875 || 41 799 ||

6.c. || Guinea-Pigs || 610 || 954 || 0 || 745 || 163 || 137 || 2 609 ||

6.d. || Hamsters || 21 || 62 || 0 || 174 || 285 || 0 || 542 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 873 || 684 || 250 || 1 336 || 469 || 121 || 3 733 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 68 || 0 || 68 ||

6.h. || Dogs || 270 || 28 || 0 || 428 || 757 || 0 || 1 483 ||

6.i. || Ferrets || 0 || 0 || 0 || 0 || 20 || 0 || 20 ||

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 || 120 || 125 || 0 || 245 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 21 || 0 || 0 || 0 || 0 || 140 || 161 ||

6.o. || Cattle || 6 || 8 || 0 || 0 || 225 || 0 || 239 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 6 || 0 || 6 ||

6.r. || Old World Monkeys || 170 || 0 || 0 || 348 || 270 || 23 || 811 ||

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 || 45 || 0 || 45 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 0 || 0 || 0 || 2 071 || 2 049 || 86 || 4 206 ||

6.z. || TOTAL || 19 432 || 8 788 || 412 || 18 372 || 25 575 || 5 462 || 78 041 ||

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 || 364 || 1 593 || 2 575 || 28 || 2 307 || 0 || 5 996 || 2 226 || 702 || 220 || 0 || 0 || 6 063 || 22 074

7.b. || Rats || 102 || 2 195 || 2 652 || 0 || 0 || 0 || 10 494 || 1 273 || 2 579 || 1 633 || 1 089 || 0 || 19 782 || 41 799

7.c. || Guinea-Pigs || 0 || 13 || 0 || 0 || 1 130 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 466 || 2 609

7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 265 || 0 || 0 || 0 || 0 || 0 || 277 || 542

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 0 || 0 || 260 || 348 || 0 || 295 || 16 || 0 || 424 || 0 || 0 || 0 || 2 390 || 3 733

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 68 || 68

7.h. || Dogs || 0 || 0 || 78 || 0 || 0 || 0 || 563 || 0 || 0 || 0 || 0 || 0 || 842 || 1 483

7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20 || 20

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 || 15 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 230 || 245

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 || 161 || 161

7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 239 || 239

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 || 6 || 6

7.r. || Old World Monkeys || 0 || 0 || 31 || 0 || 0 || 0 || 216 || 0 || 0 || 0 || 0 || 0 || 564 || 811

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 || 45 || 45

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 || 86 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 049 || 2 071 || 4 206

7.z. || TOTAL || 466 || 3 801 || 5 697 || 376 || 3 437 || 295 || 17 550 || 3 499 || 3 705 || 1 853 || 1 089 || 2 049 || 34 224 || 78 041

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 || 226 || 1 053 || 5 657 || 85 || 864 || 40 || 8 426 || 1 701 || 1 120 || 1 330 || 447 || 0 || 7 384 || 28 333

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 1 596 || 0 || 160 || 750 || 144 || 5 085 || 1 798 || 664 || 70 || 142 || 2 049 || 0 || 12 458

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 211 || 0 || 116 || 1 823 || 96 || 0 || 0 || 840 || 371 || 0 || 0 || 2 926 || 6 383

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 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 40

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

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 || 54 || 0 || 0 || 27 || 81

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 153 || 0 || 0 || 0 || 0 || 1 267 || 0 || 0 || 28 || 0 || 0 || 323 || 1 771

8.i. || Other toxicological or safety evaluations || 240 || 718 || 0 || 15 || 0 || 15 || 2 772 || 0 || 1 081 || 0 || 500 || 0 || 23 512 || 28 853

8.j. || TOTAL || 466 || 3 801 || 5 697 || 376 || 3 437 || 295 || 17 550 || 3 499 || 3 705 || 1 853 || 1 089 || 2 049 || 34 224 || 78 041

ITALY

Statistical data
submitted

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

Comments of the Italian authorities

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

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

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

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

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

53.78 %        of animals were used in basic
biological studies.

33.87 %        of animals were used for research and
development, for the production and quality control of products and appliances
for human medicine, orthodontics and veterinary medicine.

7.82 %          of animals were used in toxicological
studies.

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

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

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

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

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

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

Origin
versus species

           1.1   Spieces       || 1.2    Total ||  1.3     Animals coming from registered breeding or supplying establishments within the reporting country || 1.4     Animals coming from elsewhere in the EC ||  1.5    Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6      Animals coming from other origins || 1.7      Re-used animals

1.a.      Mice (Mus musculus) || 515946 || 486030 || 13639 || 117 || 16160 ||

1.b.     Rats (Rattus norvegicus) || 155136 || 153134 || 1067 || 0 || 935 ||

1.c.     Guinea-Pigs (Cavia porcellus) || 13784 || 11155 || 2629 || 0 || 0 ||

1.d.     Hamsters (Mesocricetus ) || 517 || 517 || 0 || 0 || 0 ||

1.e.     Other Rodents (other Rodentia) || 1946 || || || || ||

1.f.     Rabbits (Oryctolagus cuniculus) || 8392 || 7847 || 545 || 0 || 0 || 726

1.g.     Cats (Felis catus) || 0 || 0 || 0 || 0 || 0 || 0

1.h.     Dogs (Canis familiaris) || 408 || 214 || 154 || 0 || 40 || 26

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) || 34 || || || || ||

1.l.     Pigs (Sus) || 2486 || || || || ||

1.m.   Goats (Capra) || 34 || || || || ||

1.n.    Sheep (Ovis) || 243 || || || || ||

1.o.    Cattle (Bos) || 27 || || || || ||

1.p.     Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0

1.q.     New World Monkeys (Ceboidea) || 79 || 68 || 11 || 0 || 0 || 43

1.r.     Old World Monkeys (Cercopithecoidea) || 371 || 40 || 291 || 2 || 38 || 18

1.s.    Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0

1.t.     Other Mammals (other Mammalia) || 184 || || || || ||

1.u.    Quail (Coturnix coturnix) || 4 || 4 || 0 || 0 || 0 ||

1.v.    Other birds (other Aves) || 29305 || || || || ||

1.w.    Reptiles (Reptilia) || 239 || || || || ||

1.x.     Amphibians (Amphibia) || 894 || || || || ||

1.y.     Fish (Pisces) || 51786 || || || || ||

1.z.     TOTAL || 781815 || || || || ||

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 || 307552 || 112340 || 35049 || 1821 || 29226 || 25026 || 25 || 4907 || 515946

2.b. || Rats || 60920 || 23858 || 53323 || 880 || 14109 || 857 || 639 || 550 || 155136

2.c. || Guinea-Pigs || 1206 || 2812 || 2671 || 518 || 6531 || 21 || 0 || 25 || 13784

2.d. || Hamsters || 327 || 28 || 0 || 0 || 161 || 0 || 0 || 1 || 517

2.e. || Other Rodents || 92 || 493 || 0 || 0 || 0 || 1361 || 0 || 0 || 1946

2.f. || Rabbits || 556 || 398 || 4681 || 659 || 1918 || 161 || 0 || 19 || 8392

2.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.h. || Dogs || 0 || 49 || 0 || 0 || 359 || 0 || 0 || 0 || 408

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 || 23 || 0 || 0 || 0 || 0 || 8 || 0 || 3 || 34

2.l. || Pigs || 319 || 350 || 7 || 840 || 453 || 1 || 473 || 43 || 2486

2.m. || Goats || 3 || 3 || 0 || 0 || 0 || 28 || 0 || 0 || 34

2.n. || Sheep || 108 || 109 || 0 || 0 || 18 || 0 || 0 || 8 || 243

2.o. || Cattle || 5 || 0 || 0 || 20 || 2 || 0 || 0 || 0 || 27

2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.q. || New World Monkeys || 0 || 68 || 0 || 0 || 11 || 0 || 0 || 0 || 79

2.r. || Old World Monkeys || 19 || 55 || 35 || 0 || 262 || 0 || 0 || 0 || 371

2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.t. || Other Mammals || 184 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 184

2.u. || Quail || 4 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 4

2.v. || Other birds || 3694 || 664 || 5 || 19778 || 4124 || 956 || 0 || 84 || 29305

2.w. || Reptiles || 238 || 0 || 0 || 0 || 0 || 0 || 0 || 1 || 239

2.x. || Amphibians || 894 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 894

2.y. || Fish || 44307 || 1660 || 0 || 1600 || 3986 || 0 || 0 || 233 || 51786

2.z. || TOTAL || 420451 || 142887 || 95771 || 26116 || 61160 || 28419 || 1137 || 5874 || 781815

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 || 5390 || 0 || 90 || 0 || 0 || 0 || 160 || 0 || 23586 || 29226

3.b. || Rats || 10041 || 603 || 2228 || 0 || 0 || 311 || 0 || 0 || 926 || 14109

3.c. || Guinea-Pigs || 5992 || 468 || 0 || 0 || 0 || 0 || 0 || 0 || 71 || 6531

3.d. || Hamsters || 153 || 0 || 0 || 8 || 0 || 0 || 0 || 0 || 0 || 161

3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.f. || Rabbits || 1812 || 69 || 21 || 0 || 0 || 0 || 0 || 4 || 12 || 1918

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 359 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 359

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 || 309 || 0 || 0 || 0 || 0 || 0 || 144 || 0 || 0 || 453

3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.n. || Sheep || 18 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 18

3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 2

3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.q. || New World Monkeys || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11

3.r. || Old World Monkeys || 262 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 262

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 || 3620 || 0 || 0 || 0 || 0 || 0 || 504 || 0 || 0 || 4124

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 || 310 || 0 || 1866 || 0 || 0 || 0 || 0 || 1810 || 0 || 3986

3.z. || TOTAL || 28277 || 1140 || 4205 || 8 || 0 || 311 || 808 || 1814 || 24597 || 61160

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 || 17852 || 53875 || 88910 || 124413 || 17426 || 302476

4.b. || Rats || 3670 || 27783 || 5572 || 18448 || 606 || 56079

4.c. || Guinea-Pigs || 58 || 376 || 0 || 3330 || 0 || 3764

4.d. || Hamsters || 28 || 90 || 0 || 158 || 0 || 276

4.e. || Other Rodents || 0 || 0 || 0 || 1197 || 749 || 1946

4.f. || Rabbits || 122 || 43 || 3 || 545 || 179 || 892

4.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0

4.h. || Dogs || 15 || 24 || 140 || 82 || 0 || 261

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 || 73 || 0 || 9 || 165 || 1 || 248

4.m. || Goats || 0 || 0 || 0 || 0 || 31 || 31

4.n. || Sheep || 14 || 0 || 2 || 59 || 33 || 108

4.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 57 || 0 || 11 || 0 || 68

4.r. || Old World Monkeys || 4 || 10 || 42 || 50 || 0 || 106

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 0 || 5 || 5

4.u. || Quail || 0 || 0 || 0 || 0 || 4 || 4

4.v. || Other birds || 0 || 0 || 0 || 0 || 120 || 120

4.w. || Reptiles || 0 || 0 || 0 || 0 || 99 || 99

4.x. || Amphibians || 0 || 41 || 0 || 7 || 0 || 48

4.y. || Fish || 0 || 0 || 0 || 21151 || 120 || 21271

4.z. || TOTAL || 21836 || 82299 || 94678 || 169616 || 19373 || 387802

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 || 3477 || 13930 || 0 || 100 || 14863 || 4500 || 36870 ||

5.b. || Rats || 72 || 4662 || 0 || 0 || 49469 || 0 || 54203 ||

5.c. || Guinea-Pigs || 536 || 203 || 0 || 0 || 2450 || 0 || 3189 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 363 || 4063 || 0 || 0 || 914 || 0 || 5340 ||

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 || 121 || 692 || 0 || 0 || 34 || 0 || 847 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.o. || Cattle || 0 || 20 || 0 || 0 || 0 || 0 || 20 ||

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 || 35 || 0 || 35 ||

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 || 1249 || 18534 || 0 || 0 || 0 || 0 || 19783 ||

5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.y. || Fish || 1600 || 0 || 0 || 0 || 0 || 0 || 1600 ||

5.z. || TOTAL || 7418 || 42104 || 0 || 100 || 67765 || 4500 || 121887 ||

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 || 21297 || 3702 || 10 || 0 || 4212 || 5 || 29226 ||

6.b. || Rats || 3640 || 7086 || 0 || 0 || 2961 || 422 || 14109 ||

6.c. || Guinea-Pigs || 93 || 4962 || 30 || 0 || 1444 || 2 || 6531 ||

6.d. || Hamsters || 0 || 150 || 0 || 0 || 11 || 0 || 161 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 136 || 1409 || 0 || 0 || 311 || 62 || 1918 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 227 || 132 || 0 || 0 || 0 || 0 || 359 ||

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 || 453 || 0 || 0 || 0 || 0 || 453 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 18 || 0 || 0 || 0 || 0 || 18 ||

6.o. || Cattle || 2 || 0 || 0 || 0 || 0 || 0 || 2 ||

6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.q. || New World Monkeys || 0 || 11 || 0 || 0 || 0 || 0 || 11 ||

6.r. || Old World Monkeys || 51 || 0 || 0 || 0 || 211 || 0 || 262 ||

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 || 4124 || 0 || 0 || 0 || 0 || 4124 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 240 || 3476 || 0 || 0 || 0 || 270 || 3986 ||

6.z. || TOTAL || 25686 || 25523 || 40 || 0 || 9150 || 761 || 61160 ||

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 || 320 || 5089 || 11864 || 0 || 0 || 0 || 733 || 0 || 0 || 182 || 36 || 0 || 11002 || 29226

7.b. || Rats || 24 || 405 || 5618 || 6 || 0 || 0 || 4390 || 0 || 493 || 92 || 2710 || 0 || 371 || 14109

7.c. || Guinea-Pigs || 0 || 5 || 116 || 0 || 6410 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6531

7.d. || Hamsters || 0 || 0 || 0 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 150 || 161

7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.f. || Rabbits || 5 || 0 || 234 || 351 || 0 || 117 || 54 || 0 || 34 || 0 || 4 || 0 || 1119 || 1918

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 249 || 0 || 0 || 0 || 107 || 0 || 0 || 0 || 0 || 0 || 3 || 359

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 || 187 || 3 || 0 || 0 || 80 || 0 || 0 || 0 || 0 || 0 || 183 || 453

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 || 18 || 18

7.o. || Cattle || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2

7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.q. || New World Monkeys || 0 || 0 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11

7.r. || Old World Monkeys || 0 || 0 || 99 || 0 || 0 || 0 || 145 || 0 || 0 || 0 || 0 || 0 || 18 || 262

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 || 3365 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 759 || 4124

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 || 760 || 0 || 2136 || 0 || 0 || 0 || 1050 || 0 || 0 || 0 || 0 || 0 || 40 || 3986

7.z. || TOTAL || 1109 || 5499 || 23881 || 371 || 6410 || 117 || 6559 || 0 || 527 || 274 || 2750 || 0 || 13663 || 61160

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 || 329 || 402 || 12418 || 314 || 5942 || 78 || 5248 || 0 || 218 || 152 || 856 || 0 || 2320 || 28277

8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 90 || 91 || 36 || 468 || 33 || 0 || 0 || 0 || 0 || 422 || 0 || 0 || 1140

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 82 || 2149 || 21 || 0 || 6 || 100 || 0 || 289 || 90 || 1468 || 0 || 0 || 4205

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 || 8 || 8

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 || 36 || 25 || 0 || 0 || 0 || 0 || 0 || 0 || 32 || 0 || 0 || 218 || 311

8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 160 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 648 || 808

8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 760 || 0 || 0 || 0 || 0 || 0 || 1050 || 0 || 0 || 0 || 4 || 0 || 0 || 1814

8.i. || Other toxicological or safety evaluations || 20 || 4729 || 9198 || 0 || 0 || 0 || 161 || 0 || 20 || 0 || 0 || 0 || 10469 || 24597

8.j. || TOTAL || 1109 || 5499 || 23881 || 371 || 6410 || 117 || 6559 || 0 || 527 || 274 || 2750 || 0 || 13663 || 61160

CYPRUS

Statistical data submitted

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

Comments of the Cypriot 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) || 1328 || 1301 || 10 || || 17 ||

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 || 1328 || || || || ||

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

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

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

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 || 1139 || 108 || || || || || 81 || || 1328

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 || 1139 || 108 || 0 || 0 || 0 || 0 || 81 || 0 || 1328

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 || || 211 || 183 || 157 || || 551

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 || 211 || 183 || 157 || 0 || 551

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

Regulatory requirements versus
species

5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total ||

5.a. || Mice || || || || || || || 0 ||

5.b. || Rats || || || || || || || 0 ||

5.c. || Guinea-Pigs || || || || || || || 0 ||

5.d. || Hamsters || || || || || || || 0 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || || || || || || 0 ||

5.g. || Cats || || || || || || || 0 ||

5.h. || Dogs || || || || || || || 0 ||

5.i. || Ferrets || || || || || || || 0 ||

5.j. || Other Carnivores || || || || || || || 0 ||

5.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

5.l. || Pigs || || || || || || || 0 ||

5.m. || Goats || || || || || || || 0 ||

5.n. || Sheep || || || || || || || 0 ||

5.o. || Cattle || || || || || || || 0 ||

5.p. || Prosimians || || || || || || || 0 ||

5.q. || New World Monkeys || || || || || || || 0 ||

5.r. || Old World Monkeys || || || || || || || 0 ||

5.s. || Apes || || || || || || || 0 ||

5.t. || Other Mammals || || || || || || || 0 ||

5.u. || Quail || || || || || || || 0 ||

5.v. || Other birds || || || || || || || 0 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation 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 were submitted by the 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) || 6300 || 6300 || || || ||

1.b. || Rats (Rattus norvegicus) || 4020 || 4020 || || || ||

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) || 9 || || 9 || || ||

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 || 10329 || || || || ||

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

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

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

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 || 1200 || 2111 || 2989 || || || || || || 6300

2.b. || Rats || 1370 || 527 || 2123 || || || || || || 4020

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 || || 9 || || || || || || || 9

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 || 2570 || 2647 || 5112 || 0 || 0 || 0 || 0 || 0 || 10329

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 || || || || || || || || || || 0

3.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

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 || 854 || 1587 || 291 || 579 || || 3311

4.b. || Rats || 605 || 1002 || || 290 || || 1897

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 || || || || 9 || || 9

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 || 1459 || 2589 || 291 || 878 || 0 || 5217

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 || || 2989 || || || || || 2989 ||

5.b. || Rats || || 2123 || || || || || 2123 ||

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 || 5112 || 0 || 0 || 0 || 0 || 5112 ||

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

LITHUANIA

Statistical
data submitted

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

Comments of
Lithuanian authorities

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

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

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

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

Rabbits represent 6,74
% (274 animals).

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

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

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

No primates
were used.

No animals have
been used for cosmetics testing.

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) || 2131 || 2131 || || || ||

1.b. || Rats (Rattus norvegicus) || 1297 || 1297 || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 177 || 177 || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 274 || 274 || || || ||

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) || 19 || || || || ||

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) || 20 || || || || ||

1.w. || Reptiles (Reptilia) || || || || || ||

1.x. || Amphibians (Amphibia) || 149 || || || || ||

1.y. || Fish (Pisces) || || || || || ||

1.z. || TOTAL || 4067 || || || || ||

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

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

Note 3:       The number of re-used animals in column
1.7 should be excluded from the total in the column 1.2
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 || 574 || 1014 || 25 || || 200 || 309 || 9 || || 2131

2.b. || Rats || 670 || 506 || || || 26 || 90 || 5 || || 1297

2.c. || Guinea-Pigs || 55 || 110 || || || 7 || || 5 || || 177

2.d. || Hamsters || || || || || || || || || 0

2.e. || Other Rodents || || || || || || || || || 0

2.f. || Rabbits || 53 || 206 || || || 7 || 2 || 6 || || 274

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 || || 10 || || || || 9 || || || 19

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 || || 20 || || || || || || || 20

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || 149 || || 149

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 1352 || 1866 || 25 || 0 || 240 || 410 || 174 || 0 || 4067

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 || || || || || || || 200 || || || 200

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 || 0 || 0 || 0 || 0 || 0 || 0 || 240 || 0 || 0 || 240

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 || || || 300 || 400 || || 700

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 || || || || 43 || || 43

4.y. || Fish || || || || || || 0

4.z. || TOTAL || 0 || 0 || 300 || 443 || 0 || 743

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 || 25 || || || || || || 25 ||

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 || 25 || 0 || 0 || 0 || 0 || 0 || 25 ||

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 || || || 200 || || || || 200 ||

6.b. || Rats || || || 26 || || || || 26 ||

6.c. || Guinea-Pigs || || || 7 || || || || 7 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || || 7 || || || || 7 ||

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 || 240 || 0 || 0 || 0 || 240 ||

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 || || || || || || || || || || || || || 200 || 200

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 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 240 || 240

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 || || || || || || || || || || || || || 200 || 200

8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || 26 || 26

8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || 7 || 7

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 || || || || || || || || || || || || || 7 || 7

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

LUXEMBOURG

Statistical data submitted

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

Comments of Luxembourg authorities

None

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) || 470 || 470 || || || ||

1.b. || Rats (Rattus norvegicus) || 32 || 32 || || || ||

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 || 502 || || || || ||

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

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

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

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 || 470 || || || || || || || || 470

2.b. || Rats || 32 || || || || || || || || 32

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 || 502 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 502

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 || 100 || 50 || 280 || 40 || || 470

4.b. || Rats || 20 || 12 || || || || 32

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 || 120 || 62 || 280 || 40 || 0 || 502

HUNGARY

Statistical data submitted

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

Comments of the Hungarian authorities

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

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

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

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

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

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

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) || 143755 || 104761 || 38678 || 316 || 0 || 0

1.b. || Rats (Rattus norvegicus) || 70873 || 56330 || 13520 || 1023 || 0 || 0

1.c. || Guinea-Pigs (Cavia porcellus) || 9228 || 9101 || 81 || 46 || 0 || 0

1.d. || Hamsters (Mesocricetus ) || 88 || 88 || 0 || 0 || 0 || 0

1.e. || Other Rodents (other Rodentia) || 0 || 0 || 0 || 0 || 0 || 0

1.f. || Rabbits (Oryctolagus cuniculus) || 7567 || 7233 || 13 || 321 || 0 || 0

1.g. || Cats (Felis catus) || 34 || 25 || 9 || 0 || 0 || 20

1.h. || Dogs (Canis familiaris) || 675 || 370 || 144 || 161 || 0 || 88

1.i. || Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0

1.j. || Other Carnivores (other Carnivora) || 0 || 0 || 0 || 0 || 0 || 0

1.k. || Horses, donkeys and cross breds (Equidae) || 9 || 0 || 0 || 0 || 0 || 0

1.l. || Pigs (Sus) || 1278 || 79 || 2 || 0 || 0 || 0

1.m. || Goats (Capra) || 0 || 0 || 0 || 0 || 0 || 0

1.n. || Sheep (Ovis) || 160 || 0 || 0 || 0 || 0 || 0

1.o. || Cattle (Bos) || 5 || 0 || 0 || 0 || 0 || 0

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) || 7 || 7 || 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) || 235 || 235 || 0 || 0 || 0 || 0

1.v. || Other birds (other Aves) || 36304 || 0 || 0 || 0 || 0 || 0

1.w. || Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0

1.x. || Amphibians (Amphibia) || 725 || 0 || 0 || 0 || 0 || 0

1.y. || Fish (Pisces) || 5236 || 2142 || 0 || 0 || 0 || 0

1.z. || TOTAL || 276179 || 26269 || 7891 || 1577 || 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 || 34512 || 69495 || 15833 || 2992 || 15649 || 3175 || 829 || 1270 || 143755

2.b. || Rats || 22398 || 32540 || 111 || 0 || 12961 || 20 || 2123 || 720 || 70873

2.c. || Guinea-Pigs || 436 || 781 || 858 || 1508 || 5398 || 0 || 169 || 78 || 9228

2.d. || Hamsters || 88 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 88

2.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.f. || Rabbits || 2128 || 772 || 221 || 1077 || 3052 || 110 || 207 || 0 || 7567

2.g. || Cats || 14 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 34

2.h. || Dogs || 228 || 89 || 0 || 0 || 340 || 0 || 18 || 0 || 675

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 || 8 || 0 || 0 || 1 || 0 || 0 || 0 || 9

2.l. || Pigs || 885 || 101 || 0 || 252 || 39 || 0 || 1 || 0 || 1278

2.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.n. || Sheep || 6 || 37 || 0 || 112 || 0 || 0 || 0 || 5 || 160

2.o. || Cattle || 2 || 0 || 0 || 0 || 3 || 0 || 0 || 0 || 5

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 || 7 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 7

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 || 235 || 0 || 0 || 0 || 235

2.v. || Other birds || 5177 || 1485 || 0 || 27725 || 30 || 15 || 146 || 1726 || 36304

2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

2.x. || Amphibians || 125 || 0 || 0 || 0 || 0 || 0 || 600 || 0 || 725

2.y. || Fish || 374 || 0 || 0 || 0 || 4198 || 100 || 564 || 0 || 5236

2.z. || TOTAL || 66380 || 105328 || 17023 || 33666 || 41906 || 3420 || 4657 || 3799 || 276179

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 || 10608 || 560 || 921 || 0 || 0 || 0 || 0 || 139 || 3421 || 15649

3.b. || Rats || 3909 || 958 || 269 || 0 || 0 || 0 || 0 || 219 || 7606 || 12961

3.c. || Guinea-Pigs || 3854 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 1524 || 5398

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 || 1941 || 144 || 0 || 0 || 0 || 0 || 0 || 0 || 967 || 3052

3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

3.h. || Dogs || 196 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 144 || 340

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 || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1

3.l. || Pigs || 37 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 39

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 || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3

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 || 235 || 235

3.v. || Other birds || 30 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30

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 || 252 || 342 || 0 || 0 || 0 || 0 || 1720 || 1884 || 4198

3.z. || TOTAL || 20579 || 1934 || 1532 || 0 || 0 || 0 || 0 || 2078 || 15783 || 41906

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 || 993 || 61386 || 6711 || 15545 || 2316 || 86951

4.b. || Rats || 3537 || 33058 || 563 || 5954 || 0 || 43112

4.c. || Guinea-Pigs || 46 || 0 || 0 || 176 || 68 || 290

4.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0

4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0

4.f. || Rabbits || 518 || 13 || 0 || 174 || 198 || 903

4.g. || Cats || 0 || 0 || 0 || 0 || 9 || 9

4.h. || Dogs || 177 || 0 || 0 || 16 || 0 || 193

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 || 1 || 1

4.l. || Pigs || 0 || 0 || 0 || 17 || 58 || 75

4.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0

4.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0

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 || 0 || 0 || 15 || 566 || 581

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 0 || 0 || 100 || 0 || 100

4.y. || Fish || 0 || 0 || 0 || 0 || 304 || 304

4.z. || TOTAL || 5271 || 94457 || 7274 || 21997 || 3520 || 132519

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 || 14094 || 4471 || 0 || 210 || 50 || 0 || 18825 ||

5.b. || Rats || 111 || 0 || 0 || 0 || 0 || 0 || 111 ||

5.c. || Guinea-Pigs || 215 || 2151 || 0 || 0 || 0 || 0 || 2366 ||

5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.f. || Rabbits || 13 || 1233 || 0 || 52 || 0 || 0 || 1298 ||

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 || 252 || 0 || 0 || 0 || 0 || 252 ||

5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

5.n. || Sheep || 0 || 112 || 0 || 0 || 0 || 0 || 112 ||

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 || 0 || 27355 || 0 || 370 || 0 || 0 || 27725 ||

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 || 14433 || 35574 || 0 || 632 || 50 || 0 || 50689 ||

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 || 1155 || 11809 || 0 || 90 || 2112 || 483 || 15649 ||

6.b. || Rats || 466 || 5317 || 0 || 186 || 6903 || 89 || 12961 ||

6.c. || Guinea-Pigs || 0 || 1308 || 0 || 531 || 3559 || 0 || 5398 ||

6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.f. || Rabbits || 13 || 2154 || 0 || 0 || 885 || 0 || 3052 ||

6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.h. || Dogs || 16 || 99 || 0 || 81 || 144 || 0 || 340 ||

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 || 1 || 0 || 0 || 0 || 0 || 1 ||

6.l. || Pigs || 0 || 20 || 0 || 0 || 2 || 17 || 39 ||

6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.o. || Cattle || 0 || 3 || 0 || 0 || 0 || 0 || 3 ||

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 || 235 || 0 || 235 ||

6.v. || Other birds || 0 || 30 || 0 || 0 || 0 || 0 || 30 ||

6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 ||

6.y. || Fish || 1284 || 1094 || 0 || 20 || 1800 || 0 || 4198 ||

6.z. || TOTAL || 2934 || 21835 || 0 || 908 || 15640 || 589 || 41906 ||

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 || 8746 || 0 || 2189 || 0 || 2574 || 0 || 0 || 0 || 0 || 269 || 0 || 0 || 1871 || 15649

7.b. || Rats || 3915 || 0 || 3008 || 0 || 0 || 0 || 2606 || 0 || 96 || 364 || 2008 || 0 || 964 || 12889

7.c. || Guinea-Pigs || 631 || 0 || 1291 || 0 || 1822 || 0 || 1582 || 0 || 0 || 0 || 0 || 0 || 72 || 5398

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 || 1866 || 377 || 0 || 328 || 0 || 0 || 0 || 0 || 362 || 0 || 119 || 3052

7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

7.h. || Dogs || 0 || 0 || 148 || 0 || 0 || 0 || 176 || 0 || 0 || 0 || 0 || 0 || 16 || 340

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 || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1

7.l. || Pigs || 0 || 0 || 37 || 0 || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 39

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 || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3

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 || 155 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 80 || 235

7.v. || Other birds || 0 || 0 || 30 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30

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 || 2327 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 712 || 1159 || 4198

7.z. || TOTAL || 15774 || 0 || 8573 || 377 || 4396 || 328 || 4366 || 0 || 96 || 633 || 2370 || 712 || 4281 || 41906

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 || 9377 || 0 || 6655 || 19 || 395 || 0 || 2630 || 0 || 96 || 0 || 488 || 0 || 919 || 20579

8.b. || Products/substances used or intended to be used mainly in agriculture || 1043 || 0 || 388 || 97 || 95 || 97 || 0 || 0 || 0 || 0 || 124 || 0 || 90 || 1934

8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 0 || 772 || 0 || 0 || 0 || 0 || 418 || 0 || 342 || 0 || 1532

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 || 1220 || 0 || 130 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 370 || 358 || 2078

8.i. || Other toxicological or safety evaluations || 4134 || 0 || 1400 || 261 || 3134 || 231 || 1736 || 0 || 0 || 215 || 1758 || 0 || 2914 || 15783

8.j. || TOTAL || 15774 || 0 || 8573 || 377 || 4396 || 328 || 4366 || 0 || 96 || 633 || 2370 || 712 || 4281 || 41906

MALTA

Statistical data submitted

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

Comments of Malta authorities

None

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) || 0 || || || || ||

1.b. || Rats (Rattus norvegicus) || 0 || || || || ||

1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || ||

1.d. || Hamsters (Mesocricetus ) || 0 || || || || ||

1.e. || Other Rodents (other Rodentia) || 0 || || || || ||

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) || 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) || 10 || || || || ||

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 || 10 || || || || ||

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

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

Note 3:       The number of re-used animals in column
1.7 should be excluded from the total in the column 1.2
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 || || || || || || || || || 0

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 || 10 || || || || || || || || 10

2.u. || Quail || || || || || || || || || 0

2.v. || Other birds || || || || || || || || || 0

2.w. || Reptiles || || || || || || || || || 0

2.x. || Amphibians || || || || || || || || || 0

2.y. || Fish || || || || || || || || || 0

2.z. || TOTAL || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 10

THE NETHERLANDS

Statistical data submitted

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

Comments of the Dutch authorities

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

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

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

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

-
Animal experiments for new or existing cos­metics
are prohibited.

-
Since 2003 animal experiments on great apes are
prohibited.

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

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

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

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

The
creation of transgenic animals

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

Breeding of animals which had a fenotype
with harmful effect

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

Collection of data

72 establishments completed the 2011
regist­ration form.

These establishments can be categorized as follows:

a) Univer­si­t­ies and university hospitals                                                               15

b) Pub­lic health research institutes                                                                        
4

c) Agricultural and veterinary research institutes                                                 
3

d) Other research institutes                                                                                   
4

e) Industries and companies                                                                                38

f) Schools for vocational training                                                                         
6

g) Breeders                                                                                                            2

The killing of an animal without any
previous intervention

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

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

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

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

Total number of animals used

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

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

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

Discomfort

General

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

As a consequence of the animal experiments
performed in 2008:

·
36,35% of the animals experienced minor
discomfort;

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

·
21,67% of the animals experienced moderate
discomfort;

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

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

·
0.02% of the animals experienced very severe
discomfort.

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) || 237 784 || 202 725 || 31 817 || || 3 242 ||

1.b. || Rats (Rattus norvegicus) || 98 881 || 57 765 || 41 029 || || 87 ||

1.c. || Guinea-Pigs (Cavia porcellus) || 5 493 || 3 191 || 2 287 || || 15 ||

1.d. || Hamsters (Mesocricetus ) || 3 632 || 3 476 || 156 || || 0 ||

1.e. || Other Rodents (other Rodentia) || 979 || || || || ||

1.f. || Rabbits (Oryctolagus cuniculus) || 6 293 || 1 614 || 4 651 || || 28 || 138

1.g. || Cats (Felis catus) || 174 || 103 || 0 || || 71 || 22

1.h. || Dogs (Canis familiaris) || 692 || 415 || 149 || || 128 || 289

1.i. || Ferrets (Mustela putorius furo) || 852 || 0 || 666 || || 186 || 14

1.j. || Other Carnivores (other Carnivora) || 430 || || || || ||

1.k. || Horses, donkeys and cross breds (Equidae) || 2 371 || || || || ||

1.l. || Pigs (Sus) || 14 686 || || || || ||

1.m. || Goats (Capra) || 284 || || || || ||

1.n. || Sheep (Ovis) || 2 600 || || || || ||

1.o. || Cattle (Bos) || 2 383 || || || || ||

1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || || 0 || 0

1.q. || New World Monkeys (Ceboidea) || 22 || 0 || 0 || || 22 || 1

1.r. || Old World Monkeys (Cercopithecoidea) || 184 || 73 || 20 || || 91 || 111

1.s. || Apes (Hominoidea) || 0 || 0 || 0 || || 0 || 0

1.t. || Other Mammals (other Mammalia) || 41 || || || || ||

1.u. || Quail (Coturnix coturnix) || 68 || 68 || 0 || || 0 ||

1.v. || Other birds (other Aves) || 99 354 || || || || ||

1.w. || Reptiles (Reptilia) || 133 || || || || ||

1.x. || Amphibians (Amphibia) || 1 247 || || || || ||

1.y. || Fish (Pisces) || 36 034 || || || || ||

1.z. || TOTAL || 514 617 || || || || ||

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 || 166 354 || 30 471 || 4 930 || 14 372 || 5 229 || 9 380 || 7 048 || || 237 784

2.b. || Rats || 28 621 || 4 886 || 28 937 || 5 802 || 27 619 || || 3 016 || || 98 881

2.c. || Guinea-Pigs || 505 || 524 || 829 || 3 465 || 116 || || 54 || || 5 493

2.d. || Hamsters || 432 || 245 || || 2 916 || || || 39 || || 3 632

2.e. || Other Rodents || 699 || 280 || || || || || || || 979

2.f. || Rabbits || 498 || 402 || 366 || 1 973 || 2 872 || 28 || 154 || || 6 293

2.g. || Cats || 49 || || || 38 || || || 87 || || 174

2.h. || Dogs || 164 || 101 || || 183 || 152 || || 92 || || 692

2.i. || Ferrets || 282 || 497 || 58 || || || || 15 || || 852

2.j. || Other Carnivores || 121 || || || 309 || || || || || 430

2.k. || Horses, donkeys and cross breds || 24 || 194 || 101 || 2 030 || || || 22 || || 2 371

2.l. || Pigs || 8 925 || 3 387 || 6 || 1 671 || 43 || || 654 || || 14 686

2.m. || Goats || 139 || 137 || || 1 || || || 7 || || 284

2.n. || Sheep || 274 || 273 || 1 900 || 26 || || || 127 || || 2 600

2.o. || Cattle || 586 || 883 || 237 || 307 || || || 370 || || 2 383

2.p. || Prosimians || || || || || || || || || 0

2.q. || New World Monkeys || 5 || 17 || || || || || || || 22

2.r. || Old World Monkeys || 39 || 145 || || || || || || || 184

2.s. || Apes || || || || || || || || || 0

2.t. || Other Mammals || 39 || 2 || || || || || || || 41

2.u. || Quail || 68 || || || || || || || || 68

2.v. || Other birds || 65 293 || 11 532 || 22 || 21 180 || || 281 || 1 046 || || 99 354

2.w. || Reptiles || 133 || || || || || || || || 133

2.x. || Amphibians || 127 || || || || 1 120 || || || || 1 247

2.y. || Fish || 31 967 || || || || 3 580 || || 487 || || 36 034

2.z. || TOTAL || 305 344 || 53 976 || 37 386 || 54 273 || 40 731 || 9 689 || 13 218 || 0 || 514 617

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 || 3 020 || 80 || 1 985 || || || 144 || || || || 5 229

3.b. || Rats || 7 127 || 6 150 || 14 093 || 28 || || 200 || || || 21 || 27 619

3.c. || Guinea-Pigs || 67 || || 49 || || || || || || || 116

3.d. || Hamsters || || || || || || || || || || 0

3.e. || Other Rodents || || || || || || || || || || 0

3.f. || Rabbits || 1 783 || || 1 089 || || || || || || || 2 872

3.g. || Cats || || || || || || || || || || 0

3.h. || Dogs || 152 || || || || || || || || || 152

3.i. || Ferrets || || || || || || || || || || 0

3.j. || Other Carnivores || || || || || || || || || || 0

3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0

3.l. || Pigs || 43 || || || || || || || || || 43

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 || || || || || || || || 1 120 || || 1 120

3.y. || Fish || || || || || || || || 3 372 || 208 || 3 580

3.z. || TOTAL || 12 192 || 6 230 || 17 216 || 28 || 0 || 344 || 0 || 4 492 || 229 || 40 731

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 || 18 898 || 17 365 || 52 091 || 71 800 || 11 253 || 171 407

4.b. || Rats || 3 625 || 11 731 || 1 350 || 9 474 || 139 || 26 319

4.c. || Guinea-Pigs || 0 || 55 || 0 || 391 || 430 || 876

4.d. || Hamsters || 0 || 0 || 0 || 168 || 245 || 413

4.e. || Other Rodents || 0 || 0 || 0 || 288 || 0 || 288

4.f. || Rabbits || 230 || 0 || 164 || 411 || 54 || 859

4.g. || Cats || 0 || 0 || 0 || 0 || 42 || 42

4.h. || Dogs || 68 || 0 || 0 || 43 || 154 || 265

4.i. || Ferrets || 0 || 0 || 0 || 779 || 0 || 779

4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0

4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 10 || 184 || 194

4.l. || Pigs || 421 || 0 || 32 || 188 || 3 737 || 4 378

4.m. || Goats || 33 || 0 || 0 || 147 || 34 || 214

4.n. || Sheep || 10 || 0 || 0 || 271 || 266 || 547

4.o. || Cattle || 0 || 0 || 0 || 19 || 969 || 988

4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0

4.q. || New World Monkeys || 0 || 1 || 0 || 17 || 0 || 18

4.r. || Old World Monkeys || 0 || 0 || 0 || 169 || 0 || 169

4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0

4.t. || Other Mammals || 0 || 0 || 0 || 10 || 0 || 10

4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0

4.v. || Other birds || 0 || 0 || 100 || 373 || 26 516 || 26 989

4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0

4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0

4.y. || Fish || 0 || 4 162 || 119 || 936 || 184 || 5 401

4.z. || TOTAL || 23 285 || 33 314 || 53 856 || 85 494 || 44 207 || 240 156

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 || || 1 320 || || 1 864 || 11 596 || 4 522 || 19 302 ||

5.b. || Rats || || 4 354 || || 684 || 29 053 || 648 || 34 739 ||

5.c. || Guinea-Pigs || || 190 || || 250 || 2 034 || 1 820 || 4 294 ||

5.d. || Hamsters || || || || || 2 916 || || 2 916 ||

5.e. || Other Rodents || || || || || || || 0 ||

5.f. || Rabbits || || 1 || || 70 || 1 892 || 376 || 2 339 ||

5.g. || Cats || || || || || 38 || || 38 ||

5.h. || Dogs || || || || || 168 || 15 || 183 ||

5.i. || Ferrets || || || || || || 58 || 58 ||

5.j. || Other Carnivores || || || || || || 309 || 309 ||

5.k. || Horses, donkeys and cross breds || || || || || 82 || 2 049 || 2 131 ||

5.l. || Pigs || || || || || 1 290 || 387 || 1 677 ||

5.m. || Goats || || || || || || 1 || 1 ||

5.n. || Sheep || || || || || 2 || 1 924 || 1 926 ||

5.o. || Cattle || 25 || || || 4 || 104 || 411 || 544 ||

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 || || || || || 18 381 || 2 821 || 21 202 ||

5.w. || Reptiles || || || || || || || 0 ||

5.x. || Amphibians || || || || || || || 0 ||

5.y. || Fish || || || || || || || 0 ||

5.z. || TOTAL || 25 || 5 865 || 0 || 2 872 || 67 556 || 15 341 || 91 659 ||

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 || || || || 5 || 3 598 || 1 626 || 5 229 ||

6.b. || Rats || || || || 80 || 27 346 || 193 || 27 619 ||

6.c. || Guinea-Pigs || || || || || 114 || 2 || 116 ||

6.d. || Hamsters || || || || || || || 0 ||

6.e. || Other Rodents || || || || || || || 0 ||

6.f. || Rabbits || || || || || 2 863 || 9 || 2 872 ||

6.g. || Cats || || || || || || || 0 ||

6.h. || Dogs || || || || || 152 || || 152 ||

6.i. || Ferrets || || || || || || || 0 ||

6.j. || Other Carnivores || || || || || || || 0 ||

6.k. || Horses, donkeys and cross breds || || || || || || || 0 ||

6.l. || Pigs || || || || || 33 || 10 || 43 ||

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 || || || || || 1 120 || || 1 120 ||

6.y. || Fish || || || || || 3 072 || 508 || 3 580 ||

6.z. || TOTAL || 0 || 0 || 0 || 85 || 38 298 || 2 348 || 40 731 ||

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 || || 1 525 || 210 || || 2 577 || || || || || 877 || || || 40 || 5 229

7.b. || Rats || || 617 || 5 173 || 179 || || || 968 || 610 || 10 211 || 83 || 9 479 || || 299 || 27 619

7.c. || Guinea-Pigs || || || 63 || || 49 || || || || || || || || 4 || 116

7.d. || Hamsters || || || || || || || || || || || || || || 0

7.e. || Other Rodents || || || || || || || || || || || || || || 0

7.f. || Rabbits || || || 109 || 162 || || 136 || 170 || || || || 1 177 || || 1 118 || 2 872

7.g. || Cats || || || || || || || || || || || || || || 0

7.h. || Dogs || || || 99 || || || || 40 || || || || || || 13 || 152

7.i. || Ferrets || || || || || || || || || || || || || || 0

7.j. || Other Carnivores || || || || || || || || || || || || || || 0

7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0

7.l. || Pigs || || || 29 || || || || || || || || || || 14 || 43

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 || || || 1 120 || || || || || || || || || || || 1 120

7.y. || Fish || 570 || 288 || 605 || || || || 2 117 || || || || || || || 3 580

7.z. || TOTAL || 570 || 2 430 || 7 408 || 341 || 2 626 || 136 || 3 295 || 610 || 10 211 || 960 || 10 656 || 0 || 1 488 || 40 731

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 || || 1 657 || 2 789 || 100 || 1 255 || 48 || 610 || || 783 || 103 || 3 447 || || 1 400 || 12 192

8.b. || Products/substances used or intended to be used mainly in agriculture || || 16 || 455 || || || || 200 || 610 || || || 4 913 || || 36 || 6 230

8.c. || Products/substances used or intended to be used mainly in industry || || 465 || 2 383 || 241 || 1 347 || 88 || 200 || || 9 428 || 716 || 2 296 || || 52 || 17 216

8.d. || Products/substances used or intended to be used mainly in the household || || 4 || 24 || || || || || || || || || || || 28

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 || || || 32 || || 24 || || 168 || || || 120 || || || || 344

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 || 570 || 288 || 1 725 || || || || 1 909 || || || || || || || 4 492

8.i. || Other toxicological or safety evaluations || || || || || || || 208 || || || 21 || || || || 229

8.j. || TOTAL || 570 || 2 430 || 7 408 || 341 || 2 626 || 136 || 3 295 || 610 || 10 211 || 960 || 10 656 || 0 || 1 488 || 40 731

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