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Document 52010SC1107
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
/* SEC/2010/1107 final */
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EUROPEAN COMMISSION |
Brussels, 30.9.2010
SEC(2010) 1107 final
VOL B - Part II ([I], [III])
COMMISSION STAFF WORKING DOCUMENT
DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COM(2010) 511 final
Important notice
This is a document of the Commission services and cannot be considered binding to this institution in any way.
VOL B - Part II: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
TABLE OF CONTENTS
FRANCE 5
ITALY 14
CYPRUS 23
LATVIA 28
LITHUANIA 35
LUXEMBOURG 35
HUNGARY 35
MALTA 35
THE NETHERLANDS 35
FRANCE
Statistical data submitted
The statistical data have been submitted by the “Ministère de la Recherche et des Nouvelles Technologies” (Ministry for Research and New Technologies).
Comments of the French authorities
This study was realized by the EFICOM Markétudes Company for the Research and Higher Education Ministry.
The number of animals used in France shows a steady state since 1999 with about 2.5 million. It represents a decrease of 30% in comparison with the figures of the first statistical study in 1990. In 2007, a slight increasing tendency could be observed which led to values similar to the 1997 figures. Since 1999, the amount of rodents used is stable (2.1 million). Even if some animal groups are more often used (the number of birds and rabbits has doubled and the number of fish has increased by 37%), there is a reverse tendency for other species (the amount of dogs has decreased by 15%). The use of non human primates is steady from 1999, probably because of their incompressible scientific interests.
Concerning the results of the survey, when significant differences were revealed between 2007 and previous years, some verification was done in order to identify the origin of these sudden evolutions. These differences could always be explained by: either new activity, for example the production of therapeutic antibodies giving an explanation to rabbits increase observed since 2004, or the opening or the closure of laboratories. The other variations were not significant and supported the figures provided by experimental centres and laboratories.
This study showed that the public sector used half (47%) of the total amount of animals, of which 80% is for basic research and education. On the other hand, the private sector used the remaining 53%, of which 40% are dedicated to research and development, 37% to production and control, and 6% to toxicological evaluations.
Similar to the numbers observed in 2004, the present study shows that there are about 450 centres for animal experimentation (this number can vary depending on juridical conventions that link laboratories to these centres).
It represents a third of the figure established in 1990. This decrease in the number of experimental centres shows that laboratories are merged or clustered in order to share centralized installations and competent staff. The « disappearance » of 900 experimental animal houses shows the pressure brought by the animal protection associations and the concerned authorities for fifteen years. It was supported by very significant investments to come up to the current sanitary, ethic and scientific expectations. Of course, this diminution did not obviously result in a proportional decrease of the number of animals, but it sets practices that warrant respect and well-being to animals.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
1.561.809 |
1.423.488 |
47.564 |
2.534 |
88.223 |
|
|
1.b. |
Rats (Rattus norvegicus) |
392.773 |
367.102 |
16.411 |
10 |
9.250 |
|
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
46.030 |
41.952 |
3.895 |
0 |
183 |
|
|
1.d. |
Hamsters (Mesocricetus ) |
12.063 |
10.271 |
959 |
0 |
833 |
|
|
1.e. |
Other Rodents (other Rodentia) |
3.594 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
96.427 |
96.169 |
5 |
0 |
253 |
430 |
|
1.g. |
Cats (Felis catus) |
1.848 |
1.391 |
245 |
3 |
209 |
644 |
|
1.h. |
Dogs (Canis familiaris) |
4.131 |
2.928 |
262 |
0 |
941 |
805 |
|
1.i. |
Ferrets (Mustela putorius furo) |
800 |
591 |
0 |
0 |
209 |
0 |
|
1.j. |
Other Carnivores (other Carnivora) |
0 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
652 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
8.768 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
1.159 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
3.573 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
3.206 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
718 |
718 |
0 |
0 |
0 |
33 |
|
1.q. |
New World Monkeys (Ceboidea) |
233 |
213 |
20 |
0 |
0 |
135 |
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
1.797 |
610 |
262 |
0 |
925 |
244 |
|
1.s. |
Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. |
Other Mammals (other Mammalia) |
0 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
1.548 |
48 |
1.500 |
0 |
0 |
|
|
1.v. |
Other birds (other Aves) |
156.814 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
758 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
9.451 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
20.228 |
|
|
|
|
|
|
1.z. |
TOTAL |
2.328.380 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
585.129 |
429.558 |
279.987 |
45.522 |
50.866 |
12.308 |
18.947 |
139.492 |
1.561.809 |
|
2.b. |
Rats |
80.421 |
182.333 |
5.161 |
13.121 |
47.447 |
697 |
14.196 |
49.397 |
392.773 |
|
2.c. |
Guinea-Pigs |
739 |
3.705 |
30.748 |
2.230 |
7.317 |
2 |
274 |
1.015 |
46.030 |
|
2.d. |
Hamsters |
1.590 |
2.618 |
0 |
6.414 |
21 |
10 |
4 |
1.406 |
12.063 |
|
2.e. |
Other Rodents |
941 |
1.690 |
0 |
0 |
0 |
0 |
918 |
45 |
3.594 |
|
2.f. |
Rabbits |
3.348 |
6.202 |
50.152 |
7.147 |
7.737 |
125 |
799 |
20.917 |
96.427 |
|
2.g. |
Cats |
138 |
790 |
0 |
544 |
24 |
0 |
3 |
349 |
1.848 |
|
2.h. |
Dogs |
354 |
1.072 |
0 |
732 |
1.834 |
0 |
8 |
131 |
4.131 |
|
2.i. |
Ferrets |
0 |
162 |
8 |
0 |
237 |
0 |
13 |
380 |
800 |
|
2.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.k. |
Horses, donkeys and cross breds |
196 |
139 |
83 |
20 |
0 |
0 |
75 |
139 |
652 |
|
2.l. |
Pigs |
470 |
2.860 |
0 |
2.545 |
434 |
23 |
241 |
2.195 |
8.768 |
|
2.m. |
Goats |
330 |
41 |
3 |
19 |
29 |
0 |
18 |
719 |
1.159 |
|
2.n. |
Sheep |
1.331 |
638 |
27 |
655 |
205 |
0 |
56 |
661 |
3.573 |
|
2.o. |
Cattle |
310 |
541 |
0 |
298 |
84 |
140 |
30 |
1.803 |
3.206 |
|
2.p. |
Prosimians |
568 |
0 |
0 |
0 |
0 |
150 |
0 |
0 |
718 |
|
2.q. |
New World Monkeys |
63 |
77 |
0 |
0 |
0 |
0 |
0 |
93 |
233 |
|
2.r. |
Old World Monkeys |
184 |
198 |
139 |
0 |
1.128 |
0 |
0 |
148 |
1.797 |
|
2.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
1.548 |
0 |
1.548 |
|
2.v. |
Other birds |
2.821 |
7.491 |
9.280 |
86.122 |
5.251 |
1.400 |
6.593 |
37.856 |
156.814 |
|
2.w. |
Reptiles |
758 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
758 |
|
2.x. |
Amphibians |
5.013 |
52 |
0 |
0 |
179 |
0 |
4.207 |
0 |
9.451 |
|
2.y. |
Fish |
5.836 |
200 |
0 |
0 |
2.954 |
0 |
7.643 |
3.595 |
20.228 |
|
2.z. |
TOTAL |
690.540 |
640.367 |
375.588 |
165.369 |
125.747 |
14.855 |
55.573 |
260.341 |
2.328.380 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns |
3.10 Other toxico- logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
23.187 |
3.441 |
2.074 |
0 |
704 |
0 |
0 |
3.776 |
17.684 |
50.866 |
|
3.b. |
Rats |
26.440 |
6.006 |
3.375 |
159 |
0 |
0 |
0 |
1.499 |
9.968 |
47.447 |
|
3.c. |
Guinea-Pigs |
4.468 |
608 |
1.755 |
0 |
38 |
0 |
0 |
0 |
448 |
7.317 |
|
3.d. |
Hamsters |
0 |
0 |
21 |
0 |
0 |
0 |
0 |
0 |
0 |
21 |
|
3.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.f. |
Rabbits |
5.247 |
563 |
481 |
0 |
43 |
0 |
0 |
0 |
1.403 |
7.737 |
|
3.g. |
Cats |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
|
3.h. |
Dogs |
1.160 |
104 |
0 |
0 |
0 |
0 |
0 |
0 |
570 |
1.834 |
|
3.i. |
Ferrets |
237 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
237 |
|
3.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.l. |
Pigs |
404 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
0 |
434 |
|
3.m. |
Goats |
21 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
0 |
29 |
|
3.n. |
Sheep |
205 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
205 |
|
3.o. |
Cattle |
84 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
84 |
|
3.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.r. |
Old World Monkeys |
930 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
198 |
1.128 |
|
3.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.v. |
Other birds |
25 |
0 |
0 |
0 |
0 |
0 |
5.000 |
0 |
226 |
5.251 |
|
3.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.x. |
Amphibians |
179 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
179 |
|
3.y. |
Fish |
0 |
1.457 |
0 |
0 |
300 |
0 |
0 |
1.047 |
150 |
2.954 |
|
3.z. |
TOTAL |
62.611 |
12.179 |
7.706 |
159 |
1.085 |
0 |
5.000 |
6.360 |
30.647 |
125.747 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
60.574 |
232.877 |
180.979 |
333.623 |
218.942 |
1.026.995 |
|
4.b. |
Rats |
45.947 |
84.717 |
15.812 |
106.175 |
10.800 |
263.451 |
|
4.c. |
Guinea-Pigs |
479 |
312 |
190 |
2.639 |
826 |
4.446 |
|
4.d. |
Hamsters |
434 |
708 |
0 |
1.042 |
2.034 |
4.218 |
|
4.e. |
Other Rodents |
300 |
1.774 |
60 |
191 |
306 |
2.631 |
|
4.f. |
Rabbits |
1.197 |
2 |
123 |
6.710 |
1.643 |
9.675 |
|
4.g. |
Cats |
0 |
31 |
0 |
60 |
837 |
928 |
|
4.h. |
Dogs |
114 |
133 |
13 |
499 |
667 |
1.426 |
|
4.i. |
Ferrets |
0 |
0 |
0 |
162 |
0 |
162 |
|
4.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
335 |
335 |
|
4.l. |
Pigs |
736 |
0 |
0 |
547 |
2.070 |
3.353 |
|
4.m. |
Goats |
0 |
10 |
0 |
6 |
355 |
371 |
|
4.n. |
Sheep |
140 |
62 |
0 |
97 |
1.670 |
1.969 |
|
4.o. |
Cattle |
0 |
0 |
0 |
0 |
991 |
991 |
|
4.p. |
Prosimians |
0 |
40 |
0 |
308 |
370 |
718 |
|
4.q. |
New World Monkeys |
0 |
4 |
0 |
115 |
21 |
140 |
|
4.r. |
Old World Monkeys |
0 |
20 |
0 |
362 |
0 |
382 |
|
4.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.v. |
Other birds |
0 |
120 |
0 |
0 |
11.592 |
11.712 |
|
4.w. |
Reptiles |
0 |
0 |
0 |
0 |
758 |
758 |
|
4.x. |
Amphibians |
0 |
52 |
2.399 |
658 |
1.956 |
5.065 |
|
4.y. |
Fish |
900 |
250 |
0 |
930 |
3.956 |
6.036 |
|
4.z. |
TOTAL |
110.821 |
321.112 |
199.576 |
454.124 |
260.129 |
1.345.762 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
2.709 |
71.121 |
371 |
407 |
244.482 |
6.419 |
325.509 |
||||
|
5.b. |
Rats |
4.053 |
194 |
405 |
12.732 |
383 |
515 |
18.282 |
||||
|
5.c. |
Guinea-Pigs |
0 |
5.042 |
0 |
32 |
27.904 |
0 |
32.978 |
||||
|
5.d. |
Hamsters |
0 |
6.414 |
0 |
0 |
0 |
0 |
6.414 |
||||
|
5.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.f. |
Rabbits |
10 |
37.019 |
0 |
0 |
3.859 |
16.411 |
57.299 |
||||
|
5.g. |
Cats |
0 |
536 |
0 |
8 |
0 |
0 |
544 |
||||
|
5.h. |
Dogs |
0 |
732 |
0 |
0 |
0 |
0 |
732 |
||||
|
5.i. |
Ferrets |
0 |
0 |
0 |
0 |
8 |
0 |
8 |
||||
|
5.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
20 |
0 |
0 |
83 |
0 |
103 |
||||
|
5.l. |
Pigs |
0 |
2.454 |
0 |
91 |
0 |
0 |
2.545 |
||||
|
5.m. |
Goats |
19 |
0 |
0 |
0 |
3 |
0 |
22 |
||||
|
5.n. |
Sheep |
189 |
466 |
0 |
0 |
27 |
0 |
682 |
||||
|
5.o. |
Cattle |
0 |
298 |
0 |
0 |
0 |
0 |
298 |
||||
|
5.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
139 |
0 |
139 |
||||
|
5.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.v. |
Other birds |
0 |
86.034 |
0 |
80 |
9.280 |
8 |
95.402 |
||||
|
5.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.y. |
Fish |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.z. |
TOTAL |
6.980 |
210.330 |
776 |
13.350 |
286.168 |
23.353 |
540.957 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
6.960 |
13.193 |
658 |
2.783 |
20.930 |
6.342 |
50.866 |
||||
|
6.b. |
Rats |
8.250 |
5.748 |
79 |
9.219 |
20.712 |
3.439 |
47.447 |
||||
|
6.c. |
Guinea-Pigs |
286 |
2.516 |
0 |
0 |
4.515 |
0 |
7.317 |
||||
|
6.d. |
Hamsters |
21 |
0 |
0 |
0 |
0 |
0 |
21 |
||||
|
6.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.f. |
Rabbits |
260 |
1.314 |
0 |
1.405 |
4.734 |
24 |
7.737 |
||||
|
6.g. |
Cats |
0 |
24 |
0 |
0 |
0 |
0 |
24 |
||||
|
6.h. |
Dogs |
53 |
191 |
0 |
723 |
867 |
0 |
1.834 |
||||
|
6.i. |
Ferrets |
211 |
0 |
0 |
26 |
0 |
0 |
237 |
||||
|
6.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.l. |
Pigs |
55 |
18 |
0 |
149 |
212 |
0 |
434 |
||||
|
6.m. |
Goats |
29 |
0 |
0 |
0 |
0 |
0 |
29 |
||||
|
6.n. |
Sheep |
0 |
0 |
0 |
0 |
205 |
0 |
205 |
||||
|
6.o. |
Cattle |
0 |
84 |
0 |
0 |
0 |
0 |
84 |
||||
|
6.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.r. |
Old World Monkeys |
0 |
190 |
0 |
732 |
198 |
8 |
1.128 |
||||
|
6.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.v. |
Other birds |
0 |
25 |
0 |
5.000 |
0 |
226 |
5.251 |
||||
|
6.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.x. |
Amphibians |
0 |
0 |
0 |
0 |
179 |
0 |
179 |
||||
|
6.y. |
Fish |
82 |
0 |
0 |
0 |
1.457 |
1.415 |
2.954 |
||||
|
6.z. |
TOTAL |
16.207 |
23.303 |
737 |
20.037 |
54.009 |
11.454 |
125.747 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino- genicity |
7.8 Develop- mental toxicity |
7.9 Muta- genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
1.455 |
7.107 |
9.877 |
648 |
1.733 |
0 |
12.298 |
2.524 |
730 |
139 |
0 |
0 |
14.355 |
50.866 |
|
7.b. |
Rats |
36 |
1.169 |
5.128 |
12 |
1.290 |
78 |
16.839 |
5.287 |
2.075 |
1.547 |
4.489 |
0 |
9.497 |
47.447 |
|
7.c. |
Guinea-Pigs |
0 |
0 |
36 |
0 |
6.584 |
0 |
0 |
0 |
0 |
0 |
86 |
0 |
611 |
7.317 |
|
7.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
21 |
0 |
0 |
0 |
21 |
|
7.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.f. |
Rabbits |
0 |
0 |
349 |
1.059 |
0 |
377 |
568 |
0 |
669 |
0 |
965 |
0 |
3.750 |
7.737 |
|
7.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
24 |
|
7.h. |
Dogs |
0 |
0 |
461 |
0 |
0 |
0 |
1.106 |
0 |
0 |
0 |
18 |
0 |
249 |
1.834 |
|
7.i. |
Ferrets |
0 |
0 |
211 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
26 |
237 |
|
7.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.l. |
Pigs |
0 |
0 |
0 |
0 |
0 |
0 |
56 |
0 |
0 |
0 |
84 |
0 |
294 |
434 |
|
7.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
29 |
29 |
|
7.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
205 |
205 |
|
7.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
84 |
84 |
|
7.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.r. |
Old World Monkeys |
0 |
0 |
80 |
0 |
0 |
0 |
864 |
0 |
0 |
0 |
0 |
0 |
184 |
1.128 |
|
7.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5.251 |
5.251 |
|
7.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
179 |
179 |
|
7.y. |
Fish |
1.907 |
0 |
0 |
0 |
0 |
0 |
890 |
0 |
0 |
0 |
0 |
82 |
75 |
2.954 |
|
7.z. |
TOTAL |
3.398 |
8.276 |
16.142 |
1.719 |
9.607 |
455 |
32.621 |
7.811 |
3.474 |
1.707 |
5.642 |
82 |
34.813 |
125.747 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
1.965 |
5.233 |
9.654 |
638 |
4.460 |
170 |
14.646 |
3.293 |
1.141 |
1.480 |
5.211 |
0 |
14.720 |
62.611 |
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
1.430 |
310 |
0 |
100 |
608 |
88 |
5.944 |
2.682 |
867 |
0 |
150 |
0 |
0 |
12.179 |
|
8.c. |
Products/substances used or intended to be used mainly in industry |
0 |
1.378 |
665 |
942 |
1.673 |
182 |
230 |
246 |
626 |
101 |
60 |
0 |
1.603 |
7.706 |
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
0 |
0 |
0 |
0 |
0 |
159 |
0 |
0 |
0 |
0 |
0 |
0 |
159 |
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
300 |
0 |
43 |
39 |
699 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.085 |
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5.000 |
5.000 |
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
0 |
2.600 |
0 |
0 |
0 |
0 |
2.014 |
0 |
0 |
890 |
327 |
82 |
447 |
6.360 |
|
8.i. |
Other toxicological or safety evaluations |
221 |
3.397 |
589 |
0 |
0 |
6 |
3.792 |
2.604 |
300 |
0 |
1.902 |
0 |
17.836 |
30.647 |
|
8.j. |
TOTAL |
3.916 |
12.918 |
10.951 |
1.719 |
7.440 |
450 |
26.785 |
8.825 |
2.934 |
2.471 |
7.650 |
82 |
39.606 |
125.747 |
ITALY
Statistical data submitted
The statistical data have been submitted by the Ministry of Health – Department for public veterinary health food and animal safety, Directorate-General for animal health and veterinary medicines, Office X
Comments of the Italian authorities
None
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
553000 |
528861 |
12593 |
223 |
11323 |
|
|
1.b. |
Rats (Rattus norvegicus) |
230347 |
224605 |
5077 |
0 |
665 |
|
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
13875 |
9924 |
3951 |
0 |
0 |
|
|
1.d. |
Hamsters (Mesocricetus ) |
717 |
604 |
36 |
0 |
77 |
|
|
1.e. |
Other Rodents (other Rodentia) |
1235 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
9706 |
9061 |
645 |
0 |
0 |
603 |
|
1.g. |
Cats (Felis catus) |
26 |
0 |
0 |
0 |
26 |
0 |
|
1.h. |
Dogs (Canis familiaris) |
943 |
720 |
70 |
0 |
153 |
52 |
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.j. |
Other Carnivores (other Carnivora) |
0 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
46 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
3607 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
41 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
469 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
462 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.q. |
New World Monkeys (Ceboidea) |
18 |
11 |
7 |
0 |
0 |
53 |
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
344 |
182 |
107 |
2 |
53 |
72 |
|
1.s. |
Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. |
Other Mammals (other Mammalia) |
151 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
249 |
4 |
0 |
0 |
245 |
|
|
1.v. |
Other birds (other Aves) |
32241 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
454 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
2432 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
13955 |
|
|
|
|
|
|
1.z. |
TOTAL |
864318 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
311807 |
143156 |
26423 |
2300 |
34150 |
21911 |
10 |
13243 |
553000 |
|
2.b. |
Rats |
86363 |
55681 |
67788 |
205 |
17730 |
1340 |
159 |
1081 |
230347 |
|
2.c. |
Guinea-Pigs |
2710 |
2170 |
3521 |
397 |
4751 |
30 |
0 |
296 |
13875 |
|
2.d. |
Hamsters |
227 |
258 |
0 |
0 |
145 |
87 |
0 |
0 |
717 |
|
2.e. |
Other Rodents |
160 |
215 |
0 |
0 |
0 |
860 |
0 |
0 |
1235 |
|
2.f. |
Rabbits |
1628 |
1140 |
4538 |
305 |
2009 |
6 |
0 |
80 |
9706 |
|
2.g. |
Cats |
26 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
26 |
|
2.h. |
Dogs |
20 |
46 |
0 |
0 |
877 |
0 |
0 |
0 |
943 |
|
2.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.k. |
Horses, donkeys and cross breds |
31 |
0 |
15 |
0 |
0 |
0 |
0 |
0 |
46 |
|
2.l. |
Pigs |
1350 |
1174 |
15 |
84 |
435 |
0 |
344 |
205 |
3607 |
|
2.m. |
Goats |
37 |
3 |
0 |
1 |
0 |
0 |
0 |
0 |
41 |
|
2.n. |
Sheep |
171 |
190 |
62 |
12 |
23 |
0 |
0 |
11 |
469 |
|
2.o. |
Cattle |
270 |
134 |
0 |
6 |
9 |
2 |
0 |
41 |
462 |
|
2.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.q. |
New World Monkeys |
0 |
18 |
0 |
0 |
0 |
0 |
0 |
0 |
18 |
|
2.r. |
Old World Monkeys |
12 |
41 |
51 |
0 |
238 |
0 |
0 |
2 |
344 |
|
2.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.t. |
Other Mammals |
104 |
0 |
0 |
47 |
0 |
0 |
0 |
0 |
151 |
|
2.u. |
Quail |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
245 |
249 |
|
2.v. |
Other birds |
7393 |
3565 |
12 |
12736 |
6621 |
1081 |
0 |
833 |
32241 |
|
2.w. |
Reptiles |
454 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
454 |
|
2.x. |
Amphibians |
2346 |
20 |
0 |
0 |
0 |
66 |
0 |
0 |
2432 |
|
2.y. |
Fish |
6049 |
400 |
0 |
2518 |
2018 |
0 |
0 |
2970 |
13955 |
|
2.z. |
TOTAL |
421162 |
208211 |
102425 |
18611 |
69006 |
25383 |
513 |
19007 |
864318 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contaminants in the general environment which do not appear in other columns |
3.10 Other toxico-logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
8016 |
80 |
208 |
0 |
0 |
54 |
169 |
4082 |
21541 |
34150 |
|
3.b. |
Rats |
14149 |
254 |
1142 |
0 |
0 |
205 |
0 |
0 |
1980 |
17730 |
|
3.c. |
Guinea-Pigs |
4408 |
87 |
215 |
0 |
0 |
0 |
0 |
0 |
41 |
4751 |
|
3.d. |
Hamsters |
145 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
145 |
|
3.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.f. |
Rabbits |
1896 |
9 |
41 |
0 |
0 |
0 |
0 |
0 |
63 |
2009 |
|
3.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.h. |
Dogs |
877 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
877 |
|
3.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.l. |
Pigs |
147 |
0 |
0 |
0 |
0 |
0 |
288 |
0 |
0 |
435 |
|
3.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.n. |
Sheep |
23 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
23 |
|
3.o. |
Cattle |
9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
|
3.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.r. |
Old World Monkeys |
238 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
238 |
|
3.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.v. |
Other birds |
5691 |
450 |
480 |
0 |
0 |
6621 |
||||
|
3.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.y. |
Fish |
210 |
0 |
158 |
0 |
0 |
0 |
0 |
1650 |
0 |
2018 |
|
3.z. |
TOTAL |
35809 |
880 |
1764 |
0 |
0 |
259 |
937 |
5732 |
23625 |
69006 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
17719 |
72970 |
123899 |
130189 |
7073 |
351850 |
|
4.b. |
Rats |
6348 |
42732 |
4325 |
33482 |
545 |
87432 |
|
4.c. |
Guinea-Pigs |
380 |
326 |
0 |
2366 |
182 |
3254 |
|
4.d. |
Hamsters |
20 |
21 |
50 |
357 |
0 |
448 |
|
4.e. |
Other Rodents |
0 |
244 |
0 |
297 |
654 |
1195 |
|
4.f. |
Rabbits |
82 |
262 |
54 |
1410 |
13 |
1821 |
|
4.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.h. |
Dogs |
12 |
0 |
0 |
17 |
0 |
29 |
|
4.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
31 |
31 |
|
4.l. |
Pigs |
163 |
0 |
8 |
170 |
110 |
451 |
|
4.m. |
Goats |
0 |
0 |
0 |
0 |
3 |
3 |
|
4.n. |
Sheep |
31 |
0 |
0 |
42 |
16 |
89 |
|
4.o. |
Cattle |
7 |
0 |
0 |
2 |
2 |
11 |
|
4.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.q. |
New World Monkeys |
0 |
18 |
0 |
0 |
0 |
18 |
|
4.r. |
Old World Monkeys |
0 |
2 |
0 |
41 |
0 |
43 |
|
4.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.t. |
Other Mammals |
0 |
0 |
0 |
0 |
6 |
6 |
|
4.u. |
Quail |
0 |
0 |
0 |
0 |
249 |
249 |
|
4.v. |
Other birds |
0 |
0 |
0 |
0 |
1358 |
1358 |
|
4.w. |
Reptiles |
0 |
0 |
0 |
0 |
86 |
86 |
|
4.x. |
Amphibians |
0 |
101 |
0 |
241 |
66 |
408 |
|
4.y. |
Fish |
0 |
0 |
1629 |
66 |
3268 |
4963 |
|
4.z. |
TOTAL |
24762 |
116676 |
129965 |
168680 |
13662 |
453745 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
6375 |
7376 |
0 |
100 |
13027 |
1845 |
28723 |
||||
|
5.b. |
Rats |
241 |
1730 |
0 |
0 |
64208 |
1814 |
67993 |
||||
|
5.c. |
Guinea-Pigs |
657 |
627 |
0 |
0 |
2634 |
0 |
3918 |
||||
|
5.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.f. |
Rabbits |
344 |
3773 |
0 |
0 |
714 |
12 |
4843 |
||||
|
5.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.h. |
Dogs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.k. |
Horses, donkeys and cross breds |
15 |
0 |
0 |
0 |
0 |
0 |
15 |
||||
|
5.l. |
Pigs |
99 |
0 |
0 |
0 |
0 |
0 |
99 |
||||
|
5.m. |
Goats |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
||||
|
5.n. |
Sheep |
65 |
0 |
0 |
0 |
0 |
9 |
74 |
||||
|
5.o. |
Cattle |
6 |
0 |
0 |
0 |
0 |
0 |
6 |
||||
|
5.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
51 |
0 |
51 |
||||
|
5.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.t. |
Other Mammals |
13 |
34 |
0 |
0 |
0 |
0 |
47 |
||||
|
5.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.v. |
Other birds |
853 |
11895 |
0 |
0 |
0 |
0 |
12748 |
||||
|
5.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.y. |
Fish |
2170 |
0 |
0 |
0 |
348 |
0 |
2518 |
||||
|
5.z. |
TOTAL |
10839 |
25435 |
0 |
100 |
80982 |
3680 |
121036 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
19994 |
4665 |
0 |
0 |
9102 |
389 |
34150 |
||||
|
6.b. |
Rats |
2093 |
5724 |
0 |
0 |
9557 |
356 |
17730 |
||||
|
6.c. |
Guinea-Pigs |
104 |
3731 |
0 |
0 |
916 |
0 |
4751 |
||||
|
6.d. |
Hamsters |
0 |
122 |
0 |
0 |
23 |
0 |
145 |
||||
|
6.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.f. |
Rabbits |
6 |
1389 |
0 |
0 |
566 |
48 |
2009 |
||||
|
6.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.h. |
Dogs |
176 |
305 |
0 |
0 |
396 |
0 |
877 |
||||
|
6.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.l. |
Pigs |
0 |
435 |
0 |
0 |
0 |
0 |
435 |
||||
|
6.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.n. |
Sheep |
0 |
23 |
0 |
0 |
0 |
0 |
23 |
||||
|
6.o. |
Cattle |
0 |
9 |
0 |
0 |
0 |
0 |
9 |
||||
|
6.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
238 |
0 |
238 |
||||
|
6.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.v. |
Other birds |
0 |
6171 |
0 |
0 |
0 |
450 |
6621 |
||||
|
6.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.y. |
Fish |
1650 |
158 |
0 |
0 |
0 |
210 |
2018 |
||||
|
6.z. |
TOTAL |
24023 |
22732 |
0 |
0 |
20798 |
1453 |
69006 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino-genicity |
7.8 Develop-mental toxicity |
7.9 Muta-genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
590 |
5698 |
7128 |
110 |
0 |
0 |
5666 |
77 |
177 |
344 |
743 |
0 |
13617 |
34150 |
|
7.b. |
Rats |
104 |
453 |
3884 |
38 |
2 |
0 |
10261 |
2 |
507 |
363 |
717 |
0 |
1399 |
17730 |
|
7.c. |
Guinea-Pigs |
0 |
0 |
23 |
80 |
4630 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
18 |
4751 |
|
7.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
145 |
145 |
|
7.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.f. |
Rabbits |
0 |
0 |
371 |
250 |
0 |
90 |
130 |
0 |
235 |
0 |
0 |
0 |
933 |
2009 |
|
7.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.h. |
Dogs |
0 |
0 |
179 |
0 |
0 |
0 |
681 |
0 |
0 |
0 |
0 |
0 |
17 |
877 |
|
7.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.l. |
Pigs |
0 |
0 |
56 |
0 |
0 |
0 |
40 |
0 |
0 |
0 |
0 |
0 |
339 |
435 |
|
7.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
23 |
23 |
|
7.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
9 |
|
7.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.r. |
Old World Monkeys |
0 |
0 |
57 |
0 |
0 |
0 |
122 |
0 |
0 |
0 |
0 |
0 |
59 |
238 |
|
7.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.v. |
Other birds |
0 |
0 |
4595 |
1020 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1006 |
6621 |
|
7.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.y. |
Fish |
930 |
0 |
368 |
0 |
0 |
0 |
720 |
0 |
0 |
0 |
0 |
0 |
0 |
2018 |
|
7.z. |
TOTAL |
1624 |
6151 |
16661 |
1498 |
4632 |
90 |
17620 |
79 |
919 |
707 |
1460 |
0 |
17565 |
69006 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta-genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
184 |
350 |
12772 |
1469 |
4330 |
69 |
11879 |
79 |
625 |
513 |
701 |
0 |
2838 |
35809 |
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
0 |
120 |
65 |
3 |
87 |
6 |
0 |
0 |
0 |
0 |
100 |
0 |
499 |
880 |
|
8.c. |
Products/substances used or intended to be used mainly in industry |
0 |
224 |
361 |
26 |
215 |
15 |
200 |
0 |
244 |
194 |
189 |
0 |
96 |
1764 |
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
0 |
35 |
0 |
0 |
0 |
174 |
0 |
50 |
0 |
0 |
0 |
0 |
259 |
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
169 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
768 |
937 |
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
930 |
0 |
0 |
0 |
0 |
0 |
3099 |
0 |
0 |
0 |
470 |
0 |
1233 |
5732 |
|
8.i. |
Other toxicological or safety evaluations |
510 |
5288 |
3428 |
0 |
0 |
0 |
2268 |
0 |
0 |
0 |
0 |
0 |
12131 |
23625 |
|
8.j. |
TOTAL |
1624 |
6151 |
16661 |
1498 |
4632 |
90 |
17620 |
79 |
919 |
707 |
1460 |
0 |
17565 |
69006 |
CYPRUS
Statistical data submitted
The statistical data have been submitted by “Veterinary Services of the Republic of Cyprus”.
Remark: Cyprus reported data only in tables 1, 2, 4 and 5. The remaining tables are not applicable.
Comments of the Cypriot authorities
At present only rodents (mice) are used in animal experimentation in Cyprus. The use of experimental mice concentrates mainly on the generation and use of genetically modified mice to study basic biological processes like:
Development of the central nervous system and early development of the mouse embryo.
Generation of mouse models of inherited diseases or diseases with a genetic component and study of disease progression. These include haemoglobinopathies and neurodegenerative diseases.
Testing of genetically engineered molecules as putative anti-neoplastic agents on genetically immuno-compromised animals, challenged with carcinogenic cells.
Testing of modified forms of natural vitamins as potential antioxidants on induced models of diabetes.
Use of mice to study the effect of various agents on heart physiology.
The Veterinary Services are satisfied that the animals are kept in a very rigorously monitored, pathogen-free environment (monitored according to FELASA guidelines). No outbreak of all pathogens tested has been observed. We are also satisfied that the principles of the three Rs are duly adhered to.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
2114 |
2114 |
|
|||
|
1.b. |
Rats (Rattus norvegicus) |
0 |
|
||||
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
0 |
|
||||
|
1.d. |
Hamsters (Mesocricetus ) |
0 |
|
||||
|
1.e. |
Other Rodents (other Rodentia) |
|
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
0 |
|||||
|
1.g. |
Cats (Felis catus) |
0 |
|||||
|
1.h. |
Dogs (Canis familiaris) |
0 |
|||||
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
|||||
|
1.j. |
Other Carnivores (other Carnivora) |
|
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
|
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
|
|
|
|
|
|
|
1.m. |
Goats (Capra) |
|
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
|
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
|
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|||||
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
|||||
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
0 |
|||||
|
1.s. |
Apes (Hominoidea) |
0 |
|||||
|
1.t. |
Other Mammals (other Mammalia) |
|
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
|
||||
|
1.v. |
Other birds (other Aves) |
|
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
|
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
|
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
|
|
|
|
|
|
|
1.z. |
TOTAL |
2114 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
1701 |
320 |
93 |
2114 |
|||||
|
2.b. |
Rats |
0 |
||||||||
|
2.c. |
Guinea-Pigs |
0 |
||||||||
|
2.d. |
Hamsters |
0 |
||||||||
|
2.e. |
Other Rodents |
0 |
||||||||
|
2.f. |
Rabbits |
0 |
||||||||
|
2.g. |
Cats |
0 |
||||||||
|
2.h. |
Dogs |
0 |
||||||||
|
2.i. |
Ferrets |
0 |
||||||||
|
2.j. |
Other Carnivores |
0 |
||||||||
|
2.k. |
Horses, donkeys and cross breds |
0 |
||||||||
|
2.l. |
Pigs |
0 |
||||||||
|
2.m. |
Goats |
0 |
||||||||
|
2.n. |
Sheep |
0 |
||||||||
|
2.o. |
Cattle |
0 |
||||||||
|
2.p. |
Prosimians |
0 |
||||||||
|
2.q. |
New World Monkeys |
0 |
||||||||
|
2.r. |
Old World Monkeys |
0 |
||||||||
|
2.s. |
Apes |
0 |
||||||||
|
2.t. |
Other Mammals |
0 |
||||||||
|
2.u. |
Quail |
0 |
||||||||
|
2.v. |
Other birds |
0 |
||||||||
|
2.w. |
Reptiles |
0 |
||||||||
|
2.x. |
Amphibians |
0 |
||||||||
|
2.y. |
Fish |
0 |
||||||||
|
2.z. |
TOTAL |
1701 |
0 |
320 |
0 |
0 |
0 |
93 |
0 |
2114 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
205 |
70 |
165 |
440 |
||
|
4.b. |
Rats |
0 |
|||||
|
4.c. |
Guinea-Pigs |
0 |
|||||
|
4.d. |
Hamsters |
0 |
|||||
|
4.e. |
Other Rodents |
0 |
|||||
|
4.f. |
Rabbits |
0 |
|||||
|
4.g. |
Cats |
0 |
|||||
|
4.h. |
Dogs |
0 |
|||||
|
4.i. |
Ferrets |
0 |
|||||
|
4.j. |
Other Carnivores |
0 |
|||||
|
4.k. |
Horses, donkeys and cross breds |
0 |
|||||
|
4.l. |
Pigs |
0 |
|||||
|
4.m. |
Goats |
0 |
|||||
|
4.n. |
Sheep |
0 |
|||||
|
4.o. |
Cattle |
0 |
|||||
|
4.p. |
Prosimians |
0 |
|||||
|
4.q. |
New World Monkeys |
0 |
|||||
|
4.r. |
Old World Monkeys |
0 |
|||||
|
4.s. |
Apes |
0 |
|||||
|
4.t. |
Other Mammals |
0 |
|||||
|
4.u. |
Quail |
0 |
|||||
|
4.v. |
Other birds |
0 |
|||||
|
4.w. |
Reptiles |
0 |
|||||
|
4.x. |
Amphibians |
0 |
|||||
|
4.y. |
Fish |
0 |
|||||
|
4.z. |
TOTAL |
0 |
205 |
70 |
165 |
0 |
440 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
320 |
320 |
|||||||||
|
5.b. |
Rats |
0 |
||||||||||
|
5.c. |
Guinea-Pigs |
0 |
||||||||||
|
5.d. |
Hamsters |
0 |
||||||||||
|
5.e. |
Other Rodents |
0 |
||||||||||
|
5.f. |
Rabbits |
0 |
||||||||||
|
5.g. |
Cats |
0 |
||||||||||
|
5.h. |
Dogs |
0 |
||||||||||
|
5.i. |
Ferrets |
0 |
||||||||||
|
5.j. |
Other Carnivores |
0 |
||||||||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
5.l. |
Pigs |
0 |
||||||||||
|
5.m. |
Goats |
0 |
||||||||||
|
5.n. |
Sheep |
0 |
||||||||||
|
5.o. |
Cattle |
0 |
||||||||||
|
5.p. |
Prosimians |
0 |
||||||||||
|
5.q. |
New World Monkeys |
0 |
||||||||||
|
5.r. |
Old World Monkeys |
0 |
||||||||||
|
5.s. |
Apes |
0 |
||||||||||
|
5.t. |
Other Mammals |
0 |
||||||||||
|
5.u. |
Quail |
0 |
||||||||||
|
5.v. |
Other birds |
0 |
||||||||||
|
5.w. |
Reptiles |
0 |
||||||||||
|
5.x. |
Amphibians |
0 |
||||||||||
|
5.y. |
Fish |
0 |
||||||||||
|
5.z. |
TOTAL |
0 |
0 |
0 |
0 |
0 |
320 |
320 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
LATVIA
Statistical data submitted
The statistical data have been submitted by the Ministry of Agriculture – State Food and veterinary service
Comments of Latvian authorities
None
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
6912 |
6912 |
|
|||
|
1.b. |
Rats (Rattus norvegicus) |
2407 |
2407 |
|
|||
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
32 |
32 |
|
|||
|
1.d. |
Hamsters (Mesocricetus ) |
0 |
|
||||
|
1.e. |
Other Rodents (other Rodentia) |
|
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
48 |
48 |
||||
|
1.g. |
Cats (Felis catus) |
0 |
|||||
|
1.h. |
Dogs (Canis familiaris) |
0 |
|||||
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
|||||
|
1.j. |
Other Carnivores (other Carnivora) |
|
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
|
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
|
|
|
|
|
|
|
1.m. |
Goats (Capra) |
|
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
|
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
|
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|||||
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
|||||
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
0 |
|||||
|
1.s. |
Apes (Hominoidea) |
0 |
|||||
|
1.t. |
Other Mammals (other Mammalia) |
|
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
|
||||
|
1.v. |
Other birds (other Aves) |
|
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
|
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
|
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
|
|
|
|
|
|
|
1.z. |
TOTAL |
9399 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
1032 |
1952 |
2710 |
668 |
550 |
6912 |
|||
|
2.b. |
Rats |
325 |
460 |
1037 |
280 |
305 |
2407 |
|||
|
2.c. |
Guinea-Pigs |
32 |
32 |
|||||||
|
2.d. |
Hamsters |
0 |
||||||||
|
2.e. |
Other Rodents |
0 |
||||||||
|
2.f. |
Rabbits |
48 |
48 |
|||||||
|
2.g. |
Cats |
0 |
||||||||
|
2.h. |
Dogs |
0 |
||||||||
|
2.i. |
Ferrets |
0 |
||||||||
|
2.j. |
Other Carnivores |
0 |
||||||||
|
2.k. |
Horses, donkeys and cross breds |
0 |
||||||||
|
2.l. |
Pigs |
0 |
||||||||
|
2.m. |
Goats |
0 |
||||||||
|
2.n. |
Sheep |
0 |
||||||||
|
2.o. |
Cattle |
0 |
||||||||
|
2.p. |
Prosimians |
0 |
||||||||
|
2.q. |
New World Monkeys |
0 |
||||||||
|
2.r. |
Old World Monkeys |
0 |
||||||||
|
2.s. |
Apes |
0 |
||||||||
|
2.t. |
Other Mammals |
0 |
||||||||
|
2.u. |
Quail |
0 |
||||||||
|
2.v. |
Other birds |
0 |
||||||||
|
2.w. |
Reptiles |
0 |
||||||||
|
2.x. |
Amphibians |
0 |
||||||||
|
2.y. |
Fish |
0 |
||||||||
|
2.z. |
TOTAL |
1357 |
2412 |
3795 |
0 |
32 |
948 |
855 |
0 |
9399 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns |
3.10 Other toxico-logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
0 |
|||||||||
|
3.b. |
Rats |
0 |
|||||||||
|
3.c. |
Guinea-Pigs |
32 |
32 |
||||||||
|
3.d. |
Hamsters |
0 |
|||||||||
|
3.e. |
Other Rodents |
0 |
|||||||||
|
3.f. |
Rabbits |
0 |
|||||||||
|
3.g. |
Cats |
0 |
|||||||||
|
3.h. |
Dogs |
0 |
|||||||||
|
3.i. |
Ferrets |
0 |
|||||||||
|
3.j. |
Other Carnivores |
0 |
|||||||||
|
3.k. |
Horses, donkeys and cross breds |
0 |
|||||||||
|
3.l. |
Pigs |
0 |
|||||||||
|
3.m. |
Goats |
0 |
|||||||||
|
3.n. |
Sheep |
0 |
|||||||||
|
3.o. |
Cattle |
0 |
|||||||||
|
3.p. |
Prosimians |
0 |
|||||||||
|
3.q. |
New World Monkeys |
0 |
|||||||||
|
3.r. |
Old World Monkeys |
0 |
|||||||||
|
3.s. |
Apes |
0 |
|||||||||
|
3.t. |
Other Mammals |
0 |
|||||||||
|
3.u. |
Quail |
0 |
|||||||||
|
3.v. |
Other birds |
0 |
|||||||||
|
3.w. |
Reptiles |
0 |
|||||||||
|
3.x. |
Amphibians |
0 |
|||||||||
|
3.y. |
Fish |
0 |
|||||||||
|
3.z. |
TOTAL |
32 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
32 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
995 |
634 |
1353 |
548 |
122 |
3652 |
|
4.b. |
Rats |
394 |
195 |
360 |
116 |
1065 |
|
|
4.c. |
Guinea-Pigs |
0 |
|||||
|
4.d. |
Hamsters |
0 |
|||||
|
4.e. |
Other Rodents |
0 |
|||||
|
4.f. |
Rabbits |
0 |
|||||
|
4.g. |
Cats |
0 |
|||||
|
4.h. |
Dogs |
0 |
|||||
|
4.i. |
Ferrets |
0 |
|||||
|
4.j. |
Other Carnivores |
0 |
|||||
|
4.k. |
Horses, donkeys and cross breds |
0 |
|||||
|
4.l. |
Pigs |
0 |
|||||
|
4.m. |
Goats |
0 |
|||||
|
4.n. |
Sheep |
0 |
|||||
|
4.o. |
Cattle |
0 |
|||||
|
4.p. |
Prosimians |
0 |
|||||
|
4.q. |
New World Monkeys |
0 |
|||||
|
4.r. |
Old World Monkeys |
0 |
|||||
|
4.s. |
Apes |
0 |
|||||
|
4.t. |
Other Mammals |
0 |
|||||
|
4.u. |
Quail |
0 |
|||||
|
4.v. |
Other birds |
0 |
|||||
|
4.w. |
Reptiles |
0 |
|||||
|
4.x. |
Amphibians |
0 |
|||||
|
4.y. |
Fish |
0 |
|||||
|
4.z. |
TOTAL |
1389 |
829 |
1713 |
664 |
122 |
4717 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
2710 |
2710 |
|||||||||
|
5.b. |
Rats |
1037 |
1037 |
|||||||||
|
5.c. |
Guinea-Pigs |
0 |
||||||||||
|
5.d. |
Hamsters |
0 |
||||||||||
|
5.e. |
Other Rodents |
0 |
||||||||||
|
5.f. |
Rabbits |
48 |
48 |
|||||||||
|
5.g. |
Cats |
0 |
||||||||||
|
5.h. |
Dogs |
0 |
||||||||||
|
5.i. |
Ferrets |
0 |
||||||||||
|
5.j. |
Other Carnivores |
0 |
||||||||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
5.l. |
Pigs |
0 |
||||||||||
|
5.m. |
Goats |
0 |
||||||||||
|
5.n. |
Sheep |
0 |
||||||||||
|
5.o. |
Cattle |
0 |
||||||||||
|
5.p. |
Prosimians |
0 |
||||||||||
|
5.q. |
New World Monkeys |
0 |
||||||||||
|
5.r. |
Old World Monkeys |
0 |
||||||||||
|
5.s. |
Apes |
0 |
||||||||||
|
5.t. |
Other Mammals |
0 |
||||||||||
|
5.u. |
Quail |
0 |
||||||||||
|
5.v. |
Other birds |
0 |
||||||||||
|
5.w. |
Reptiles |
0 |
||||||||||
|
5.x. |
Amphibians |
0 |
||||||||||
|
5.y. |
Fish |
0 |
||||||||||
|
5.z. |
TOTAL |
0 |
0 |
0 |
0 |
3795 |
0 |
3795 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
0 |
||||||||||
|
6.b. |
Rats |
|||||||||||
|
6.c. |
Guinea-Pigs |
32 |
32 |
|||||||||
|
6.d. |
Hamsters |
0 |
||||||||||
|
6.e. |
Other Rodents |
0 |
||||||||||
|
6.f. |
Rabbits |
0 |
||||||||||
|
6.g. |
Cats |
0 |
||||||||||
|
6.h. |
Dogs |
0 |
||||||||||
|
6.i. |
Ferrets |
0 |
||||||||||
|
6.j. |
Other Carnivores |
0 |
||||||||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
6.l. |
Pigs |
0 |
||||||||||
|
6.m. |
Goats |
0 |
||||||||||
|
6.n. |
Sheep |
0 |
||||||||||
|
6.o. |
Cattle |
0 |
||||||||||
|
6.p. |
Prosimians |
0 |
||||||||||
|
6.q. |
New World Monkeys |
0 |
||||||||||
|
6.r. |
Old World Monkeys |
0 |
||||||||||
|
6.s. |
Apes |
0 |
||||||||||
|
6.t. |
Other Mammals |
0 |
||||||||||
|
6.u. |
Quail |
0 |
||||||||||
|
6.v. |
Other birds |
0 |
||||||||||
|
6.w. |
Reptiles |
0 |
||||||||||
|
6.x. |
Amphibians |
0 |
||||||||||
|
6.y. |
Fish |
0 |
||||||||||
|
6.z. |
TOTAL |
0 |
0 |
0 |
0 |
32 |
0 |
32 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino- genicity |
7.8 Develop-mental toxicity |
7.9 Muta-genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
0 |
|||||||||||||
|
7.b. |
Rats |
||||||||||||||
|
7.c. |
Guinea-Pigs |
32 |
32 |
||||||||||||
|
7.d. |
Hamsters |
0 |
|||||||||||||
|
7.e. |
Other Rodents |
0 |
|||||||||||||
|
7.f. |
Rabbits |
0 |
|||||||||||||
|
7.g. |
Cats |
0 |
|||||||||||||
|
7.h. |
Dogs |
0 |
|||||||||||||
|
7.i. |
Ferrets |
0 |
|||||||||||||
|
7.j. |
Other Carnivores |
0 |
|||||||||||||
|
7.k. |
Horses, donkeys and cross breds |
0 |
|||||||||||||
|
7.l. |
Pigs |
0 |
|||||||||||||
|
7.m. |
Goats |
0 |
|||||||||||||
|
7.n. |
Sheep |
0 |
|||||||||||||
|
7.o. |
Cattle |
0 |
|||||||||||||
|
7.p. |
Prosimians |
0 |
|||||||||||||
|
7.q. |
New World Monkeys |
0 |
|||||||||||||
|
7.r. |
Old World Monkeys |
0 |
|||||||||||||
|
7.s. |
Apes |
0 |
|||||||||||||
|
7.t. |
Other Mammals |
0 |
|||||||||||||
|
7.u. |
Quail |
0 |
|||||||||||||
|
7.v. |
Other birds |
0 |
|||||||||||||
|
7.w. |
Reptiles |
0 |
|||||||||||||
|
7.x. |
Amphibians |
0 |
|||||||||||||
|
7.y. |
Fish |
0 |
|||||||||||||
|
7.z. |
TOTAL |
0 |
0 |
0 |
32 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
32 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
32 |
32 |
||||||||||||
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
0 |
|||||||||||||
|
8.c. |
Products/substances used or intended to be used mainly in industry |
0 |
|||||||||||||
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
|||||||||||||
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
|||||||||||||
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
|||||||||||||
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
|||||||||||||
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
0 |
|||||||||||||
|
8.i. |
Other toxicological or safety evaluations |
0 |
|||||||||||||
|
8.j. |
TOTAL |
0 |
0 |
0 |
32 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
32 |
LITHUANIA
Statistical data submitted
The statistical data have been submitted by the Animal Health and Welfare Department of the State Food and Veterinary Service of the Republic of Lithuania.
Comments of Lithuanian authorities
The legal basis for the collection of statistics on the number and use of vertebrate animals for experimental and other scientific purposes in Lithuania is provided by the State Food and Veterinary Service Director Decree No B1-639 (Government Gazette 2009-01-22, No 8-287) on the protection of animals used for experimental and other scientific purposes, in accordance with Council Directive 86/609/EEC and European Convention on the protection of animals used for experimental and other scientific purposes
The total number of animals used in experiments in Lithuania in 2008 was 5,582 of which 100% animals came from registered breeding or supplying establishments within the reporting country.
Rodents accounted for 91,61% of all animals used – 5,114 animals (3,827 mice – accounting for 68,56%, 1,194 rats - accounting for 21,39%, 93 guinea pigs – accounting for 1,67%)
A further 3,56% (199 animals) were rabbits.
Cold-blooded animals (fish and amphibians) represented 2,67% of the animals used, 149 animals, of which 28,86% were used for research and development of medical, dental and veterinary products and appliances, 71,14% for education and training purposes.
Pigs accounted for 1,43% of the animals used (80 animals), of which 37,5% were used for research and development of medical, dental and veterinary products and appliances, 62,5% for education and training purposes.
Birds accounted for 0,71% (40 animals), of which 100% were used for research and development of medical, dental and veterinary products and appliances.
No animals were re-used.
No primates were used.
No animals were used in the testing of cosmetic products.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
3827 |
3827 |
|
|
|
|
|
1.b. |
Rats (Rattus norvegicus) |
1194 |
1194 |
|
|
|
|
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
93 |
93 |
|
|
|
|
|
1.d. |
Hamsters (Mesocricetus ) |
0 |
|
|
|
|
|
|
1.e. |
Other Rodents (other Rodentia) |
|
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
199 |
199 |
|
|
|
|
|
1.g. |
Cats (Felis catus) |
0 |
|
|
|
|
|
|
1.h. |
Dogs (Canis familiaris) |
0 |
|
|
|
|
|
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
|
|
|
|
|
|
1.j. |
Other Carnivores (other Carnivora) |
|
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
|
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
80 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
|
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
|
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
|
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|
|
|
|
|
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
|
|
|
|
|
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
0 |
|
|
|
|
|
|
1.s. |
Apes (Hominoidea) |
0 |
|
|
|
|
|
|
1.t. |
Other Mammals (other Mammalia) |
|
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
|
|
|
|
|
|
1.v. |
Other birds (other Aves) |
40 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
|
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
149 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
|
|
|
|
|
|
|
1.z. |
TOTAL |
5582 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
718 |
1367 |
525 |
|
1213 |
|
4 |
|
3827 |
|
2.b. |
Rats |
44 |
1070 |
33 |
|
26 |
|
21 |
|
1194 |
|
2.c. |
Guinea-Pigs |
41 |
40 |
|
5 |
7 |
|
|
|
93 |
|
2.d. |
Hamsters |
|
|
|
|
|
|
|
|
0 |
|
2.e. |
Other Rodents |
|
|
|
|
|
|
|
|
0 |
|
2.f. |
Rabbits |
8 |
148 |
|
5 |
7 |
|
31 |
|
199 |
|
2.g. |
Cats |
|
|
|
|
|
|
|
|
0 |
|
2.h. |
Dogs |
|
|
|
|
|
|
|
|
0 |
|
2.i. |
Ferrets |
|
|
|
|
|
|
|
|
0 |
|
2.j. |
Other Carnivores |
|
|
|
|
|
|
|
|
0 |
|
2.k. |
Horses, donkeys and cross breds |
|
|
|
|
|
|
|
|
0 |
|
2.l. |
Pigs |
|
30 |
|
|
|
|
50 |
|
80 |
|
2.m. |
Goats |
|
|
|
|
|
|
|
|
0 |
|
2.n. |
Sheep |
|
|
|
|
|
|
|
|
0 |
|
2.o. |
Cattle |
|
|
|
|
|
|
|
|
0 |
|
2.p. |
Prosimians |
|
|
|
|
|
|
|
|
0 |
|
2.q. |
New World Monkeys |
|
|
|
|
|
|
|
|
0 |
|
2.r. |
Old World Monkeys |
|
|
|
|
|
|
|
|
0 |
|
2.s. |
Apes |
|
|
|
|
|
|
|
|
0 |
|
2.t. |
Other Mammals |
|
|
|
|
|
|
|
|
0 |
|
2.u. |
Quail |
|
|
|
|
|
|
|
|
0 |
|
2.v. |
Other birds |
|
40 |
|
|
|
|
|
|
40 |
|
2.w. |
Reptiles |
|
|
|
|
|
|
|
|
0 |
|
2.x. |
Amphibians |
|
43 |
|
|
|
|
106 |
|
149 |
|
2.y. |
Fish |
|
|
|
|
|
|
|
|
0 |
|
2.z. |
TOTAL |
811 |
2738 |
558 |
10 |
1253 |
0 |
212 |
0 |
5582 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns |
3.10 Other toxico-logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
239 |
|
|
|
|
|
200 |
|
774 |
1213 |
|
3.b. |
Rats |
|
|
|
|
|
|
26 |
|
|
26 |
|
3.c. |
Guinea-Pigs |
|
|
|
|
|
|
7 |
|
|
7 |
|
3.d. |
Hamsters |
|
|
|
|
|
|
|
|
|
0 |
|
3.e. |
Other Rodents |
|
|
|
|
|
|
|
|
|
0 |
|
3.f. |
Rabbits |
|
|
|
|
|
|
7 |
|
|
7 |
|
3.g. |
Cats |
|
|
|
|
|
|
|
|
|
0 |
|
3.h. |
Dogs |
|
|
|
|
|
|
|
|
|
0 |
|
3.i. |
Ferrets |
|
|
|
|
|
|
|
|
|
0 |
|
3.j. |
Other Carnivores |
|
|
|
|
|
|
|
|
|
0 |
|
3.k. |
Horses, donkeys and cross breds |
|
|
|
|
|
|
|
|
|
0 |
|
3.l. |
Pigs |
|
|
|
|
|
|
|
|
|
0 |
|
3.m. |
Goats |
|
|
|
|
|
|
|
|
|
0 |
|
3.n. |
Sheep |
|
|
|
|
|
|
|
|
|
0 |
|
3.o. |
Cattle |
|
|
|
|
|
|
|
|
|
0 |
|
3.p. |
Prosimians |
|
|
|
|
|
|
|
|
|
0 |
|
3.q. |
New World Monkeys |
|
|
|
|
|
|
|
|
|
0 |
|
3.r. |
Old World Monkeys |
|
|
|
|
|
|
|
|
|
0 |
|
3.s. |
Apes |
|
|
|
|
|
|
|
|
|
0 |
|
3.t. |
Other Mammals |
|
|
|
|
|
|
|
|
|
0 |
|
3.u. |
Quail |
|
|
|
|
|
|
|
|
|
0 |
|
3.v. |
Other birds |
|
|
|
|
|
|
|
|
|
0 |
|
3.w. |
Reptiles |
|
|
|
|
|
|
|
|
|
0 |
|
3.x. |
Amphibians |
|
|
|
|
|
|
|
|
|
0 |
|
3.y. |
Fish |
|
|
|
|
|
|
|
|
|
0 |
|
3.z. |
TOTAL |
239 |
0 |
0 |
0 |
0 |
0 |
240 |
0 |
774 |
1253 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
189 |
|
300 |
1496 |
100 |
2085 |
|
4.b. |
Rats |
22 |
|
33 |
959 |
100 |
1114 |
|
4.c. |
Guinea-Pigs |
39 |
|
|
22 |
20 |
81 |
|
4.d. |
Hamsters |
|
|
|
|
|
0 |
|
4.e. |
Other Rodents |
|
|
|
|
|
0 |
|
4.f. |
Rabbits |
30 |
24 |
|
82 |
20 |
156 |
|
4.g. |
Cats |
|
|
|
|
|
0 |
|
4.h. |
Dogs |
|
|
|
|
|
0 |
|
4.i. |
Ferrets |
|
|
|
|
|
0 |
|
4.j. |
Other Carnivores |
|
|
|
|
|
0 |
|
4.k. |
Horses, donkeys and cross breds |
|
|
|
|
|
0 |
|
4.l. |
Pigs |
30 |
|
|
|
|
30 |
|
4.m. |
Goats |
|
|
|
|
|
0 |
|
4.n. |
Sheep |
|
|
|
|
|
0 |
|
4.o. |
Cattle |
|
|
|
|
|
0 |
|
4.p. |
Prosimians |
|
|
|
|
|
0 |
|
4.q. |
New World Monkeys |
|
|
|
|
|
0 |
|
4.r. |
Old World Monkeys |
|
|
|
|
|
0 |
|
4.s. |
Apes |
|
|
|
|
|
0 |
|
4.t. |
Other Mammals |
|
|
|
|
|
0 |
|
4.u. |
Quail |
|
|
|
|
|
0 |
|
4.v. |
Other birds |
|
|
|
20 |
20 |
40 |
|
4.w. |
Reptiles |
|
|
|
|
|
0 |
|
4.x. |
Amphibians |
|
43 |
|
|
|
43 |
|
4.y. |
Fish |
|
|
|
|
|
0 |
|
4.z. |
TOTAL |
310 |
67 |
333 |
2579 |
260 |
3549 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
525 |
|
|
|
|
|
525 |
||||
|
5.b. |
Rats |
33 |
|
|
|
|
|
33 |
||||
|
5.c. |
Guinea-Pigs |
5 |
|
|
|
|
|
5 |
||||
|
5.d. |
Hamsters |
|
|
|
|
|
|
0 |
||||
|
5.e. |
Other Rodents |
|
|
|
|
|
|
0 |
||||
|
5.f. |
Rabbits |
5 |
|
|
|
|
|
5 |
||||
|
5.g. |
Cats |
|
|
|
|
|
|
0 |
||||
|
5.h. |
Dogs |
|
|
|
|
|
|
0 |
||||
|
5.i. |
Ferrets |
|
|
|
|
|
|
0 |
||||
|
5.j. |
Other Carnivores |
|
|
|
|
|
|
0 |
||||
|
5.k. |
Horses, donkeys and cross breds |
|
|
|
|
|
|
0 |
||||
|
5.l. |
Pigs |
|
|
|
|
|
|
0 |
||||
|
5.m. |
Goats |
|
|
|
|
|
|
0 |
||||
|
5.n. |
Sheep |
|
|
|
|
|
|
0 |
||||
|
5.o. |
Cattle |
|
|
|
|
|
|
0 |
||||
|
5.p. |
Prosimians |
|
|
|
|
|
|
0 |
||||
|
5.q. |
New World Monkeys |
|
|
|
|
|
|
0 |
||||
|
5.r. |
Old World Monkeys |
|
|
|
|
|
|
0 |
||||
|
5.s. |
Apes |
|
|
|
|
|
|
0 |
||||
|
5.t. |
Other Mammals |
|
|
|
|
|
|
0 |
||||
|
5.u. |
Quail |
|
|
|
|
|
|
0 |
||||
|
5.v. |
Other birds |
|
|
|
|
|
|
0 |
||||
|
5.w. |
Reptiles |
|
|
|
|
|
|
0 |
||||
|
5.x. |
Amphibians |
|
|
|
|
|
|
0 |
||||
|
5.y. |
Fish |
|
|
|
|
|
|
0 |
||||
|
5.z. |
TOTAL |
568 |
0 |
0 |
0 |
0 |
0 |
568 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
1013 |
200 |
|
|
|
|
1213 |
|||||
|
6.b. |
|
26 |
|
|
|
|
26 |
|||||
|
6.c. |
|
7 |
|
|
|
|
7 |
|||||
|
6.d. |
|
|
|
|
|
|
0 |
|||||
|
6.e. |
|
|
|
|
|
|
0 |
|||||
|
6.f. |
|
7 |
|
|
|
|
7 |
|||||
|
6.g. |
|
|
|
|
|
|
0 |
|||||
|
6.h. |
|
|
|
|
|
|
0 |
|||||
|
6.i. |
|
|
|
|
|
|
0 |
|||||
|
6.j. |
|
|
|
|
|
|
0 |
|||||
|
6.k. |
|
|
|
|
|
|
0 |
|||||
|
6.l. |
|
|
|
|
|
|
0 |
|||||
|
6.m. |
|
|
|
|
|
|
0 |
|||||
|
6.n. |
|
|
|
|
|
|
0 |
|||||
|
6.o. |
|
|
|
|
|
|
0 |
|||||
|
6.p. |
|
|
|
|
|
|
0 |
|||||
|
6.q. |
|
|
|
|
|
|
0 |
|||||
|
6.r. |
|
|
|
|
|
|
0 |
|||||
|
6.s. |
|
|
|
|
|
|
0 |
|||||
|
6.t. |
|
|
|
|
|
|
0 |
|||||
|
6.u. |
|
|
|
|
|
|
0 |
|||||
|
6.v. |
|
|
|
|
|
|
0 |
|||||
|
6.w. |
|
|
|
|
|
|
0 |
|||||
|
6.x. |
|
|
|
|
|
|
0 |
|||||
|
6.y. |
|
|
|
|
|
|
0 |
|||||
|
6.z. |
1013 |
240 |
0 |
0 |
0 |
0 |
1253 |
|||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino-genicity |
7.8 Develop-mental toxicity |
7.9 Muta-genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
172 |
|
|
|
|
|
|
|
|
246 |
|
200 |
595 |
1213 |
|
7.b. |
Rats |
|
|
|
|
|
|
|
|
|
|
|
26 |
|
26 |
|
7.c. |
Guinea-Pigs |
|
|
|
|
|
|
|
|
|
|
|
7 |
|
7 |
|
7.d. |
Hamsters |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.e. |
Other Rodents |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.f. |
Rabbits |
|
|
|
|
|
|
|
|
|
|
|
7 |
|
7 |
|
7.g. |
Cats |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.h. |
Dogs |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.i. |
Ferrets |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.j. |
Other Carnivores |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.k. |
Horses, donkeys and cross breds |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.l. |
Pigs |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.m. |
Goats |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.n. |
Sheep |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.o. |
Cattle |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.p. |
Prosimians |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.q. |
New World Monkeys |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.r. |
Old World Monkeys |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.s. |
Apes |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.t. |
Other Mammals |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.u. |
Quail |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.v. |
Other birds |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.w. |
Reptiles |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.x. |
Amphibians |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.y. |
Fish |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
7.z. |
TOTAL |
172 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
246 |
0 |
240 |
595 |
1253 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
172 |
|
|
|
|
|
|
|
|
|
|
|
67 |
239 |
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
8.c. |
Products/substances used or intended to be used mainly in industry |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
8.d. |
Products/substances used or intended to be used mainly in the household |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
|
|
|
|
|
|
|
|
|
|
|
|
240 |
240 |
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
|
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
8.i. |
Other toxicological or safety evaluations |
|
|
|
|
|
|
|
|
|
246 |
|
|
528 |
774 |
|
8.j. |
TOTAL |
172 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
246 |
0 |
0 |
835 |
1253 |
LUXEMBOURG
Statistical data submitted
The statistical data have been submitted by the “Ministère de l’Agriculture, de la viticulture et du developpement rural. Administration des Services Vétérinaires” (Ministry of Agriculture, viticulture and rural development. Administration of Veterinary Services)
Remark: Luxembourg reported data only in tables 1, 2 and 4 with the remaining tables not applicable.
Comments of Luxembourg authorities
None
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
3280 |
3280 |
|
|||
|
1.b. |
Rats (Rattus norvegicus) |
430 |
430 |
|
|||
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
100 |
100 |
|
|||
|
1.d. |
Hamsters (Mesocricetus ) |
0 |
|
||||
|
1.e. |
Other Rodents (other Rodentia) |
0 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
20 |
20 |
||||
|
1.g. |
Cats (Felis catus) |
0 |
|||||
|
1.h. |
Dogs (Canis familiaris) |
0 |
|||||
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
|||||
|
1.j. |
Other Carnivores (other Carnivora) |
0 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
0 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
0 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
0 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
0 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
0 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|||||
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
|||||
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
0 |
|||||
|
1.s. |
Apes (Hominoidea) |
0 |
|||||
|
1.t. |
Other Mammals (other Mammalia) |
0 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
|
||||
|
1.v. |
Other birds (other Aves) |
0 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
0 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
0 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
0 |
|
|
|
|
|
|
1.z. |
TOTAL |
3830 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
3280 |
3280 |
|||||||
|
2.b. |
Rats |
430 |
430 |
|||||||
|
2.c. |
Guinea-Pigs |
100 |
100 |
|||||||
|
2.d. |
Hamsters |
0 |
||||||||
|
2.e. |
Other Rodents |
0 |
||||||||
|
2.f. |
Rabbits |
20 |
20 |
|||||||
|
2.g. |
Cats |
0 |
||||||||
|
2.h. |
Dogs |
0 |
||||||||
|
2.i. |
Ferrets |
0 |
||||||||
|
2.j. |
Other Carnivores |
0 |
||||||||
|
2.k. |
Horses, donkeys and cross breds |
0 |
||||||||
|
2.l. |
Pigs |
0 |
||||||||
|
2.m. |
Goats |
0 |
||||||||
|
2.n. |
Sheep |
0 |
||||||||
|
2.o. |
Cattle |
0 |
||||||||
|
2.p. |
Prosimians |
0 |
||||||||
|
2.q. |
New World Monkeys |
0 |
||||||||
|
2.r. |
Old World Monkeys |
0 |
||||||||
|
2.s. |
Apes |
0 |
||||||||
|
2.t. |
Other Mammals |
0 |
||||||||
|
2.u. |
Quail |
0 |
||||||||
|
2.v. |
Other birds |
0 |
||||||||
|
2.w. |
Reptiles |
0 |
||||||||
|
2.x. |
Amphibians |
0 |
||||||||
|
2.y. |
Fish |
0 |
||||||||
|
2.z. |
TOTAL |
0 |
3830 |
0 |
0 |
0 |
0 |
0 |
0 |
3830 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
3280 |
3280 |
||||
|
4.b. |
Rats |
430 |
430 |
||||
|
4.c. |
Guinea-Pigs |
100 |
100 |
||||
|
4.d. |
Hamsters |
0 |
|||||
|
4.e. |
Other Rodents |
0 |
|||||
|
4.f. |
Rabbits |
20 |
20 |
||||
|
4.g. |
Cats |
0 |
|||||
|
4.h. |
Dogs |
0 |
|||||
|
4.i. |
Ferrets |
0 |
|||||
|
4.j. |
Other Carnivores |
0 |
|||||
|
4.k. |
Horses, donkeys and cross breds |
0 |
|||||
|
4.l. |
Pigs |
0 |
|||||
|
4.m. |
Goats |
0 |
|||||
|
4.n. |
Sheep |
0 |
|||||
|
4.o. |
Cattle |
0 |
|||||
|
4.p. |
Prosimians |
0 |
|||||
|
4.q. |
New World Monkeys |
0 |
|||||
|
4.r. |
Old World Monkeys |
0 |
|||||
|
4.s. |
Apes |
0 |
|||||
|
4.t. |
Other Mammals |
0 |
|||||
|
4.u. |
Quail |
0 |
|||||
|
4.v. |
Other birds |
0 |
|||||
|
4.w. |
Reptiles |
0 |
|||||
|
4.x. |
Amphibians |
0 |
|||||
|
4.y. |
Fish |
0 |
|||||
|
4.z. |
TOTAL |
0 |
0 |
0 |
0 |
3830 |
3830 |
HUNGARY
Statistical data submitted
The statistical data have been submitted by the Ministry of Agriculture and Rural Development.
Comments of the Hungarian authorities
None
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
158799 |
129817 |
26099 |
1131 |
1752 |
|
|
1.b. |
Rats (Rattus norvegicus) |
89375 |
73336 |
15248 |
340 |
451 |
|
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
9743 |
6064 |
3669 |
10 |
0 |
|
|
1.d. |
Hamsters (Mesocricetus ) |
215 |
215 |
0 |
0 |
0 |
|
|
1.e. |
Other Rodents (other Rodentia) |
356 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
8134 |
7560 |
14 |
360 |
200 |
598 |
|
1.g. |
Cats (Felis catus) |
40 |
40 |
0 |
0 |
0 |
|
|
1.h. |
Dogs (Canis familiaris) |
686 |
412 |
12 |
262 |
0 |
65 |
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
|||||
|
1.j. |
Other Carnivores (other Carnivora) |
0 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
40 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
1193 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
92 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
200 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
93 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|||||
|
1.q. |
New World Monkeys (Ceboidea) |
5 |
5 |
||||
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
1 |
1 |
||||
|
1.s. |
Apes (Hominoidea) |
0 |
|||||
|
1.t. |
Other Mammals (other Mammalia) |
16 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
13 |
13 |
|
|||
|
1.v. |
Other birds (other Aves) |
32554 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
108 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
1182 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
2077 |
|
|
|
|
|
|
1.z. |
TOTAL |
304922 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
50186 |
57384 |
23136 |
0 |
13495 |
3935 |
5706 |
4957 |
158799 |
|
2.b. |
Rats |
24239 |
60144 |
0 |
0 |
2809 |
15 |
2143 |
25 |
89375 |
|
2.c. |
Guinea-Pigs |
2304 |
629 |
3699 |
774 |
2006 |
0 |
235 |
96 |
9743 |
|
2.d. |
Hamsters |
214 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
215 |
|
2.e. |
Other Rodents |
356 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
356 |
|
2.f. |
Rabbits |
1360 |
2183 |
0 |
618 |
3620 |
66 |
287 |
0 |
8134 |
|
2.g. |
Cats |
6 |
34 |
0 |
0 |
0 |
0 |
0 |
0 |
40 |
|
2.h. |
Dogs |
352 |
59 |
7 |
0 |
240 |
0 |
23 |
5 |
686 |
|
2.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
40 |
0 |
40 |
|
2.l. |
Pigs |
399 |
292 |
0 |
159 |
156 |
130 |
57 |
0 |
1193 |
|
2.m. |
Goats |
2 |
0 |
0 |
0 |
0 |
50 |
40 |
0 |
92 |
|
2.n. |
Sheep |
10 |
26 |
0 |
82 |
0 |
0 |
82 |
0 |
200 |
|
2.o. |
Cattle |
6 |
4 |
0 |
2 |
30 |
51 |
0 |
0 |
93 |
|
2.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.q. |
New World Monkeys |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
|
2.r. |
Old World Monkeys |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|
2.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.t. |
Other Mammals |
0 |
16 |
0 |
0 |
0 |
0 |
0 |
0 |
16 |
|
2.u. |
Quail |
13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
13 |
|
2.v. |
Other birds |
7558 |
8158 |
0 |
13390 |
462 |
10 |
576 |
2400 |
32554 |
|
2.w. |
Reptiles |
0 |
50 |
0 |
0 |
0 |
0 |
58 |
0 |
108 |
|
2.x. |
Amphibians |
120 |
0 |
0 |
0 |
0 |
0 |
1062 |
0 |
1182 |
|
2.y. |
Fish |
345 |
0 |
0 |
0 |
1126 |
100 |
506 |
0 |
2077 |
|
2.z. |
TOTAL |
87476 |
128979 |
26842 |
15025 |
23944 |
4357 |
10816 |
7483 |
304922 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns |
3.10 Other toxico- logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
11093 |
0 |
0 |
0 |
0 |
0 |
288 |
0 |
2114 |
13495 |
|
3.b. |
Rats |
1129 |
0 |
0 |
0 |
0 |
78 |
0 |
0 |
1602 |
2809 |
|
3.c. |
Guinea-Pigs |
1236 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
770 |
2006 |
|
3.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.f. |
Rabbits |
3428 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
192 |
3620 |
|
3.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.h. |
Dogs |
240 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
240 |
|
3.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.l. |
Pigs |
122 |
0 |
0 |
0 |
0 |
0 |
0 |
34 |
0 |
156 |
|
3.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.o. |
Cattle |
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
|
3.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.v. |
Other birds |
462 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
462 |
|
3.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.y. |
Fish |
0 |
126 |
0 |
0 |
0 |
0 |
0 |
1000 |
0 |
1126 |
|
3.z. |
TOTAL |
17740 |
126 |
0 |
0 |
0 |
78 |
288 |
1034 |
4678 |
23944 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
886 |
69114 |
8615 |
27448 |
5442 |
111505 |
|
4.b. |
Rats |
2564 |
72436 |
1777 |
7621 |
0 |
84398 |
|
4.c. |
Guinea-Pigs |
72 |
314 |
0 |
2482 |
65 |
2933 |
|
4.d. |
Hamsters |
0 |
109 |
0 |
83 |
22 |
214 |
|
4.e. |
Other Rodents |
0 |
290 |
0 |
66 |
0 |
356 |
|
4.f. |
Rabbits |
447 |
613 |
0 |
1782 |
767 |
3609 |
|
4.g. |
Cats |
0 |
30 |
0 |
0 |
10 |
40 |
|
4.h. |
Dogs |
390 |
21 |
0 |
0 |
0 |
411 |
|
4.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.l. |
Pigs |
194 |
0 |
0 |
0 |
627 |
821 |
|
4.m. |
Goats |
2 |
0 |
0 |
0 |
50 |
52 |
|
4.n. |
Sheep |
0 |
0 |
0 |
0 |
36 |
36 |
|
4.o. |
Cattle |
0 |
0 |
0 |
0 |
61 |
61 |
|
4.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.q. |
New World Monkeys |
5 |
0 |
0 |
0 |
0 |
5 |
|
4.r. |
Old World Monkeys |
1 |
0 |
0 |
0 |
0 |
1 |
|
4.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.t. |
Other Mammals |
16 |
0 |
0 |
0 |
0 |
16 |
|
4.u. |
Quail |
0 |
0 |
0 |
0 |
13 |
13 |
|
4.v. |
Other birds |
0 |
0 |
0 |
0 |
15726 |
15726 |
|
4.w. |
Reptiles |
0 |
50 |
0 |
0 |
0 |
50 |
|
4.x. |
Amphibians |
0 |
120 |
0 |
0 |
0 |
120 |
|
4.y. |
Fish |
0 |
0 |
0 |
0 |
445 |
445 |
|
4.z. |
TOTAL |
4577 |
143097 |
10392 |
39482 |
23264 |
220812 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
9363 |
13523 |
0 |
0 |
250 |
0 |
23136 |
||||
|
5.b. |
Rats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.c. |
Guinea-Pigs |
586 |
3887 |
0 |
0 |
0 |
0 |
4473 |
||||
|
5.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.f. |
Rabbits |
40 |
578 |
0 |
0 |
0 |
0 |
618 |
||||
|
5.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.h. |
Dogs |
7 |
0 |
0 |
0 |
0 |
0 |
7 |
||||
|
5.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.l. |
Pigs |
0 |
159 |
0 |
0 |
0 |
0 |
159 |
||||
|
5.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.n. |
Sheep |
6 |
76 |
0 |
0 |
0 |
0 |
82 |
||||
|
5.o. |
Cattle |
0 |
2 |
0 |
0 |
0 |
0 |
2 |
||||
|
5.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.v. |
Other birds |
11 |
13379 |
0 |
0 |
0 |
0 |
13390 |
||||
|
5.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.y. |
Fish |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.z. |
TOTAL |
10013 |
31604 |
0 |
0 |
250 |
0 |
41867 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
60 |
12533 |
0 |
0 |
460 |
442 |
13495 |
||||
|
6.b. |
Rats |
152 |
1657 |
0 |
0 |
910 |
90 |
2809 |
||||
|
6.c. |
Guinea-Pigs |
0 |
1236 |
0 |
0 |
770 |
0 |
2006 |
||||
|
6.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.f. |
Rabbits |
550 |
2878 |
0 |
0 |
192 |
0 |
3620 |
||||
|
6.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.h. |
Dogs |
110 |
66 |
58 |
6 |
0 |
0 |
240 |
||||
|
6.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.l. |
Pigs |
81 |
67 |
8 |
0 |
0 |
0 |
156 |
||||
|
6.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.o. |
Cattle |
0 |
30 |
0 |
0 |
0 |
0 |
30 |
||||
|
6.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.v. |
Other birds |
0 |
462 |
0 |
0 |
0 |
0 |
462 |
||||
|
6.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.y. |
Fish |
1000 |
126 |
0 |
0 |
0 |
0 |
1126 |
||||
|
6.z. |
TOTAL |
1953 |
19055 |
66 |
6 |
2332 |
532 |
23944 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino- genicity |
7.8 Develop- mental toxicity |
7.9 Muta- genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
3307 |
4492 |
3194 |
0 |
0 |
0 |
160 |
0 |
0 |
323 |
0 |
0 |
2019 |
13495 |
|
7.b. |
Rats |
30 |
26 |
1200 |
0 |
85 |
0 |
400 |
24 |
190 |
30 |
218 |
0 |
606 |
2809 |
|
7.c. |
Guinea-Pigs |
0 |
0 |
976 |
0 |
420 |
0 |
490 |
0 |
120 |
0 |
0 |
0 |
0 |
2006 |
|
7.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.f. |
Rabbits |
0 |
0 |
3420 |
41 |
4 |
28 |
0 |
0 |
127 |
0 |
0 |
0 |
0 |
3620 |
|
7.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
7.h. |
Dogs |
0 |
0 |
108 |
0 |
0 |
0 |
132 |
0 |
0 |
0 |
0 |
0 |
0 |
240 |
|
7.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.l. |
Pigs |
0 |
0 |
77 |
0 |
0 |
0 |
20 |
0 |
0 |
0 |
0 |
0 |
59 |
156 |
|
7.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
30 |
|
7.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.v. |
Other birds |
72 |
0 |
390 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
462 |
|
7.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.y. |
Fish |
626 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
500 |
0 |
1126 |
|
|
7.z. |
TOTAL |
4035 |
4518 |
9365 |
41 |
509 |
28 |
1202 |
24 |
437 |
353 |
218 |
500 |
2714 |
23944 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
3374 |
4492 |
6997 |
41 |
509 |
28 |
1202 |
0 |
437 |
353 |
218 |
0 |
89 |
17740 |
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
126 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
126 |
|
8.c. |
Products/substances used or intended to be used mainly in industry |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
26 |
28 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
78 |
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
288 |
288 |
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
500 |
0 |
34 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
500 |
0 |
1034 |
|
8.i. |
Other toxicological or safety evaluations |
35 |
0 |
2306 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2337 |
4678 |
|
8.j. |
TOTAL |
4035 |
4518 |
9365 |
41 |
509 |
28 |
1202 |
24 |
437 |
353 |
218 |
500 |
2714 |
23944 |
MALTA
Statistical data submitted
The data were submitted by the Ministry of Resources and Rural Affairs
Comments of Malta authorities
None
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
50 |
50 |
|
|||
|
1.b. |
Rats (Rattus norvegicus) |
44 |
44 |
|
|||
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
0 |
|
||||
|
1.d. |
Hamsters (Mesocricetus ) |
0 |
|
||||
|
1.e. |
Other Rodents (other Rodentia) |
|
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
0 |
|||||
|
1.g. |
Cats (Felis catus) |
0 |
|||||
|
1.h. |
Dogs (Canis familiaris) |
0 |
|||||
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
|||||
|
1.j. |
Other Carnivores (other Carnivora) |
|
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
|
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
|
|
|
|
|
|
|
1.m. |
Goats (Capra) |
|
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
|
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
|
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|||||
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
|||||
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
0 |
|||||
|
1.s. |
Apes (Hominoidea) |
0 |
|||||
|
1.t. |
Other Mammals (other Mammalia) |
|
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
|
||||
|
1.v. |
Other birds (other Aves) |
|
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
|
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
|
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
600 |
|
|
|
|
|
|
1.z. |
TOTAL |
694 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
50 |
50 |
|||||||
|
2.b. |
Rats |
44 |
44 |
|||||||
|
2.c. |
Guinea-Pigs |
0 |
||||||||
|
2.d. |
Hamsters |
0 |
||||||||
|
2.e. |
Other Rodents |
0 |
||||||||
|
2.f. |
Rabbits |
0 |
||||||||
|
2.g. |
Cats |
0 |
||||||||
|
2.h. |
Dogs |
0 |
||||||||
|
2.i. |
Ferrets |
0 |
||||||||
|
2.j. |
Other Carnivores |
0 |
||||||||
|
2.k. |
Horses, donkeys and cross breds |
0 |
||||||||
|
2.l. |
Pigs |
0 |
||||||||
|
2.m. |
Goats |
0 |
||||||||
|
2.n. |
Sheep |
0 |
||||||||
|
2.o. |
Cattle |
0 |
||||||||
|
2.p. |
Prosimians |
0 |
||||||||
|
2.q. |
New World Monkeys |
0 |
||||||||
|
2.r. |
Old World Monkeys |
0 |
||||||||
|
2.s. |
Apes |
0 |
||||||||
|
2.t. |
Other Mammals |
0 |
||||||||
|
2.u. |
Quail |
0 |
||||||||
|
2.v. |
Other birds |
0 |
||||||||
|
2.w. |
Reptiles |
0 |
||||||||
|
2.x. |
Amphibians |
0 |
||||||||
|
2.y. |
Fish |
600 |
600 |
|||||||
|
2.z. |
TOTAL |
0 |
50 |
44 |
0 |
600 |
0 |
0 |
0 |
694 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns |
3.10 Other toxico-logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
0 |
|||||||||
|
3.b. |
Rats |
0 |
|||||||||
|
3.c. |
Guinea-Pigs |
0 |
|||||||||
|
3.d. |
Hamsters |
0 |
|||||||||
|
3.e. |
Other Rodents |
0 |
|||||||||
|
3.f. |
Rabbits |
0 |
|||||||||
|
3.g. |
Cats |
0 |
|||||||||
|
3.h. |
Dogs |
0 |
|||||||||
|
3.i. |
Ferrets |
0 |
|||||||||
|
3.j. |
Other Carnivores |
0 |
|||||||||
|
3.k. |
Horses, donkeys and cross breds |
0 |
|||||||||
|
3.l. |
Pigs |
0 |
|||||||||
|
3.m. |
Goats |
0 |
|||||||||
|
3.n. |
Sheep |
0 |
|||||||||
|
3.o. |
Cattle |
0 |
|||||||||
|
3.p. |
Prosimians |
0 |
|||||||||
|
3.q. |
New World Monkeys |
0 |
|||||||||
|
3.r. |
Old World Monkeys |
0 |
|||||||||
|
3.s. |
Apes |
0 |
|||||||||
|
3.t. |
Other Mammals |
0 |
|||||||||
|
3.u. |
Quail |
0 |
|||||||||
|
3.v. |
Other birds |
0 |
|||||||||
|
3.w. |
Reptiles |
0 |
|||||||||
|
3.x. |
Amphibians |
0 |
|||||||||
|
3.y. |
Fish |
600 |
600 |
||||||||
|
3.z. |
TOTAL |
600 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
600 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
50 |
50 |
||||
|
4.b. |
Rats |
44 |
44 |
||||
|
4.c. |
Guinea-Pigs |
0 |
|||||
|
4.d. |
Hamsters |
0 |
|||||
|
4.e. |
Other Rodents |
0 |
|||||
|
4.f. |
Rabbits |
0 |
|||||
|
4.g. |
Cats |
0 |
|||||
|
4.h. |
Dogs |
0 |
|||||
|
4.i. |
Ferrets |
0 |
|||||
|
4.j. |
Other Carnivores |
0 |
|||||
|
4.k. |
Horses, donkeys and cross breds |
0 |
|||||
|
4.l. |
Pigs |
0 |
|||||
|
4.m. |
Goats |
0 |
|||||
|
4.n. |
Sheep |
0 |
|||||
|
4.o. |
Cattle |
0 |
|||||
|
4.p. |
Prosimians |
0 |
|||||
|
4.q. |
New World Monkeys |
0 |
|||||
|
4.r. |
Old World Monkeys |
0 |
|||||
|
4.s. |
Apes |
0 |
|||||
|
4.t. |
Other Mammals |
0 |
|||||
|
4.u. |
Quail |
0 |
|||||
|
4.v. |
Other birds |
0 |
|||||
|
4.w. |
Reptiles |
0 |
|||||
|
4.x. |
Amphibians |
0 |
|||||
|
4.y. |
Fish |
0 |
|||||
|
4.z. |
TOTAL |
0 |
50 |
44 |
0 |
0 |
94 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
0 |
||||||||||
|
5.b. |
Rats |
44 |
44 |
|||||||||
|
5.c. |
Guinea-Pigs |
0 |
||||||||||
|
5.d. |
Hamsters |
0 |
||||||||||
|
5.e. |
Other Rodents |
0 |
||||||||||
|
5.f. |
Rabbits |
0 |
||||||||||
|
5.g. |
Cats |
0 |
||||||||||
|
5.h. |
Dogs |
0 |
||||||||||
|
5.i. |
Ferrets |
0 |
||||||||||
|
5.j. |
Other Carnivores |
0 |
||||||||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
5.l. |
Pigs |
0 |
||||||||||
|
5.m. |
Goats |
0 |
||||||||||
|
5.n. |
Sheep |
0 |
||||||||||
|
5.o. |
Cattle |
0 |
||||||||||
|
5.p. |
Prosimians |
0 |
||||||||||
|
5.q. |
New World Monkeys |
0 |
||||||||||
|
5.r. |
Old World Monkeys |
0 |
||||||||||
|
5.s. |
Apes |
0 |
||||||||||
|
5.t. |
Other Mammals |
0 |
||||||||||
|
5.u. |
Quail |
0 |
||||||||||
|
5.v. |
Other birds |
0 |
||||||||||
|
5.w. |
Reptiles |
0 |
||||||||||
|
5.x. |
Amphibians |
0 |
||||||||||
|
5.y. |
Fish |
0 |
||||||||||
|
5.z. |
TOTAL |
|||||||||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
0 |
||||||||||
|
6.b. |
Rats |
0 |
||||||||||
|
6.c. |
Guinea-Pigs |
0 |
||||||||||
|
6.d. |
Hamsters |
0 |
||||||||||
|
6.e. |
Other Rodents |
0 |
||||||||||
|
6.f. |
Rabbits |
0 |
||||||||||
|
6.g. |
Cats |
0 |
||||||||||
|
6.h. |
Dogs |
0 |
||||||||||
|
6.i. |
Ferrets |
0 |
||||||||||
|
6.j. |
Other Carnivores |
0 |
||||||||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
6.l. |
Pigs |
0 |
||||||||||
|
6.m. |
Goats |
0 |
||||||||||
|
6.n. |
Sheep |
0 |
||||||||||
|
6.o. |
Cattle |
0 |
||||||||||
|
6.p. |
Prosimians |
0 |
||||||||||
|
6.q. |
New World Monkeys |
0 |
||||||||||
|
6.r. |
Old World Monkeys |
0 |
||||||||||
|
6.s. |
Apes |
0 |
||||||||||
|
6.t. |
Other Mammals |
0 |
||||||||||
|
6.u. |
Quail |
0 |
||||||||||
|
6.v. |
Other birds |
0 |
||||||||||
|
6.w. |
Reptiles |
0 |
||||||||||
|
6.x. |
Amphibians |
0 |
||||||||||
|
6.y. |
Fish |
600 |
600 |
|||||||||
|
6.z. |
TOTAL |
600 |
0 |
0 |
0 |
0 |
0 |
600 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino-genicity |
7.8 Develop- mental toxicity |
7.9 Muta-genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
0 |
|||||||||||||
|
7.b. |
Rats |
0 |
|||||||||||||
|
7.c. |
Guinea-Pigs |
0 |
|||||||||||||
|
7.d. |
Hamsters |
0 |
|||||||||||||
|
7.e. |
Other Rodents |
0 |
|||||||||||||
|
7.f. |
Rabbits |
0 |
|||||||||||||
|
7.g. |
Cats |
0 |
|||||||||||||
|
7.h. |
Dogs |
0 |
|||||||||||||
|
7.i. |
Ferrets |
0 |
|||||||||||||
|
7.j. |
Other Carnivores |
0 |
|||||||||||||
|
7.k. |
Horses, donkeys and cross breds |
0 |
|||||||||||||
|
7.l. |
Pigs |
0 |
|||||||||||||
|
7.m. |
Goats |
0 |
|||||||||||||
|
7.n. |
Sheep |
0 |
|||||||||||||
|
7.o. |
Cattle |
0 |
|||||||||||||
|
7.p. |
Prosimians |
0 |
|||||||||||||
|
7.q. |
New World Monkeys |
0 |
|||||||||||||
|
7.r. |
Old World Monkeys |
0 |
|||||||||||||
|
7.s. |
Apes |
0 |
|||||||||||||
|
7.t. |
Other Mammals |
0 |
|||||||||||||
|
7.u. |
Quail |
0 |
|||||||||||||
|
7.v. |
Other birds |
0 |
|||||||||||||
|
7.w. |
Reptiles |
0 |
|||||||||||||
|
7.x. |
Amphibians |
0 |
|||||||||||||
|
7.y. |
Fish |
600 |
600 |
||||||||||||
|
7.z. |
TOTAL |
600 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
600 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta-genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
600 |
600 |
||||||||||||
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
0 |
|||||||||||||
|
8.c. |
Products/substances used or intended to be used mainly in industry |
0 |
|||||||||||||
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
|||||||||||||
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
|||||||||||||
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
|||||||||||||
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
|||||||||||||
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
0 |
|||||||||||||
|
8.i. |
Other toxicological or safety evaluations |
0 |
|||||||||||||
|
8.j. |
TOTAL |
600 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
600 |
THE NETHERLANDS
Statistical data submitted
The statistical data have been submitted by the “Keuringsdienst van Waren, Ministerie voor Volksgezondheid, Welzijn en Sport” (Inspectorate for Goods, Ministry for Public Health, Welfare and Sports
The statistical data were prepared, quality assured and submitted by the Voedsel en Waren Autoriteit, (Dutch Food and Consumer Product Safety Authority
Comments of the Dutch authorities
On 5 February 1997, the revised version of the Experiments on Animals Act (1977) entered into force.
The provisions of the European Directive on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (86/609/EEC) have been implemented.
In addition, among others the following provisions have been issued:
Animal experiments using LD50/LC50 methods are prohibited. However, for acute dermal and acute respiratory toxicity tests a general exemption is granted, due to the lack of validated alternative methods.
Animal experiments for new or existing cosmetics are prohibited.
Since 2003 animal experiments on great apes are prohibited.
Every animal experiment to be performed has to be recommended by a recognised ethical review committee. Such a committee comprises at least seven members, one of whom is the chairperson. In addition, such a committee comprises in equal numbers experts in the fields of animal experiments, experts in the field of alternative methods, experts in the field of animal welfare and protection and experts in the field of ethical assessment. At least two of these experts are not involved in the conduct of experiments on animals. The chairperson and at least two members are not in the employment of any licence holder applying to the committee. The animal welfare officer is involved already at an early stage in the review of experiments and acts as a permanent advisor for the ethical review committee. At this moment 23 ethical review committees are recognized.
Licenses to perform animal experiments are issued by the Minister of Public Health, Welfare and Sport to a natural or legal person who is a mandated representative of an establishment for animal use. So licensed, those people are responsible for assuring that the legal requirements are complied with. The welfare of the experimental animals is supervised by a qualified veterinarian or another competent person in charge of the licensee.
A Standing Committee advises the Minister on the administration of the Act and other related issues. The Committee consists of experts in the field of animal experimentation, laboratory animal science and animal welfare.
The enforcement of the Act has been commissioned to the Food and Consumer Product Safety Authority.
The creation of transgenic animals
Within the framework of the Animal Health and Welfare Act (1992) a system of licensing has entered into force with respect to experiments aiming at a genetic modification of animals. A national committee on ethical evaluation of genetic modification of animals, called the Committee on Animal Biotechnology will advise the Minister of Agriculture, Nature Management and Fisheries on the ethical aspects of the creation and the use of transgenic animals in general and on the admissibility of proposed projects.
In addition, such projects have to be evaluated within the framework of the Experiments of Animals Act and the Environmental Conservation Act.
The Inspectorate of the Food and Consumer Product Safety Authority is in charge of the supervision of these licences to create genetically modified animals.
In 2008 12,186 animals (12,052 mice, 72 rats and 62 fish) were used for the creation of transgenic animals.
Collection of data
87 establishments completed the 2008 registration form.
These establishments can be categorized as follows:
|
a) |
Universities and university hospitals |
15 |
|
b) |
Other hospitals, regional public health laboratories |
1 |
|
c) |
Public health research institutes |
8 |
|
d) |
Agricultural and veterinary research institutes |
8 |
|
e) |
Other research institutes |
4 |
|
f) |
Industries and companies |
40 |
|
g) |
Schools for vocational training |
8 |
|
h) |
Breeders |
3 |
The killing of an animal without any previous intervention & re-use of animals
In the Netherlands, the killing of an animal without any previous intervention in the framework of research or testing, e.g. for organ/blood collection, is considered to be an experiment. The rationale of this is that the Inspectorate must have the power to supervise the killing of laboratory animals.
This is in contrast to the Council of Europe Convention ETS 123 and Directive 86/609/EEC, where the use of an animal for an experimental or other scientific purpose is not considered an experiment if the least painful method of killing accepted in modern practice (‘humane’ methods’) is used.
In 2008, 60,391 animals were killed without previous intervention.
Re-use of the animals (in 2008 17,220 animals) is included as well in the Dutch statistics.
Total number of animals used
In 2008, according to the EU Tables, the total number of animals used was 501,056.
This is 1,6% (10,060) less than the number of animals used in 2007 (513,423).
The total number of genetically modified animals that was used was 83,097. When split up into species, the numbers of genetically modified animals used are: 81,089 mice, 284 rats, 81 rabbits, 225 amphibians and 1,418 fish.
In 2008 the number of animals used for toxicological and other safety evaluation was decreased with 24,7% (13,431) compared to the number used in 2007.
Discomfort
General
Data has to be registered after an experiment has been performed. This includes data on the degree of discomfort; i.e. experienced discomfort.
As a consequence of the animal experiments performed in 2008:
33,66% of the animals experienced minor discomfort;
28,52% of the animals experienced minor/moderate discomfort;
25,05% of the animals experienced moderate discomfort;
9,11% of the animals experienced moderate/severe discomfort;
3,63% of the animals experienced severe discomfort and
0,03% of the animals experienced very severe discomfort.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
237681 |
228113 |
8160 |
0 |
1408 |
2164 |
|
1.b. |
Rats (Rattus norvegicus) |
105780 |
105300 |
231 |
0 |
249 |
2716 |
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
6062 |
2939 |
3123 |
0 |
0 |
130 |
|
1.d. |
Hamsters (Mesocricetus ) |
3358 |
3077 |
281 |
0 |
0 |
54 |
|
1.e. |
Other Rodents (other Rodentia) |
2439 |
1642 |
73 |
0 |
724 |
0 |
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
7418 |
6755 |
646 |
0 |
17 |
109 |
|
1.g. |
Cats (Felis catus) |
253 |
100 |
0 |
0 |
153 |
23 |
|
1.h. |
Dogs (Canis familiaris) |
1244 |
464 |
208 |
0 |
572 |
268 |
|
1.i. |
Ferrets (Mustela putorius furo) |
472 |
0 |
193 |
0 |
279 |
20 |
|
1.j. |
Other Carnivores (other Carnivora) |
10 |
0 |
0 |
0 |
10 |
0 |
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
2562 |
3 |
0 |
0 |
2559 |
164 |
|
1.l. |
Pigs (Sus) |
11729 |
4192 |
216 |
0 |
7321 |
125 |
|
1.m. |
Goats (Capra) |
229 |
52 |
0 |
0 |
177 |
80 |
|
1.n. |
Sheep (Ovis) |
3486 |
67 |
0 |
0 |
3419 |
470 |
|
1.o. |
Cattle (Bos) |
2236 |
232 |
35 |
0 |
1969 |
187 |
|
1.p. |
Prosimians (Prosimia) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.q. |
New World Monkeys (Ceboidea) |
73 |
73 |
0 |
0 |
0 |
8 |
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
82 |
62 |
16 |
0 |
4 |
202 |
|
1.s. |
Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. |
Other Mammals (other Mammalia) |
202 |
0 |
0 |
0 |
202 |
7 |
|
1.u. |
Quail (Coturnix coturnix) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.v. |
Other birds (other Aves) |
90890 |
12995 |
472 |
0 |
77423 |
4119 |
|
1.w. |
Reptiles (Reptilia) |
121 |
100 |
0 |
0 |
21 |
28 |
|
1.x. |
Amphibians (Amphibia) |
870 |
785 |
0 |
0 |
85 |
482 |
|
1.y. |
Fish (Pisces) |
23859 |
8518 |
126 |
0 |
15215 |
270 |
|
1.z. |
TOTAL |
501056 |
0 |
0 |
0 |
0 |
0 |
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
152304 |
40617 |
5624 |
15653 |
7522 |
8859 |
7102 |
0 |
237681 |
|
2.b. |
Rats |
31930 |
15348 |
28320 |
2700 |
23284 |
0 |
4198 |
0 |
105780 |
|
2.c. |
Guinea-Pigs |
488 |
373 |
767 |
4181 |
183 |
0 |
70 |
0 |
6062 |
|
2.d. |
Hamsters |
444 |
330 |
0 |
2539 |
30 |
0 |
15 |
0 |
3358 |
|
2.e. |
Other Rodents |
2222 |
217 |
0 |
0 |
0 |
0 |
0 |
0 |
2439 |
|
2.f. |
Rabbits |
727 |
393 |
16 |
1653 |
4543 |
5 |
81 |
0 |
7418 |
|
2.g. |
Cats |
0 |
45 |
0 |
85 |
44 |
0 |
79 |
0 |
253 |
|
2.h. |
Dogs |
157 |
285 |
11 |
187 |
519 |
0 |
85 |
0 |
1244 |
|
2.i. |
Ferrets |
28 |
414 |
0 |
0 |
0 |
0 |
30 |
0 |
472 |
|
2.j. |
Other Carnivores |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
|
2.k. |
Horses, donkeys and cross breds |
65 |
377 |
110 |
2007 |
0 |
0 |
3 |
0 |
2562 |
|
2.l. |
Pigs |
5138 |
3693 |
3 |
2283 |
188 |
0 |
424 |
0 |
11729 |
|
2.m. |
Goats |
135 |
50 |
0 |
0 |
0 |
0 |
44 |
0 |
229 |
|
2.n. |
Sheep |
133 |
639 |
2576 |
85 |
0 |
0 |
53 |
0 |
3486 |
|
2.o. |
Cattle |
248 |
1012 |
129 |
598 |
0 |
0 |
249 |
0 |
2236 |
|
2.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.q. |
New World Monkeys |
28 |
45 |
0 |
0 |
0 |
0 |
0 |
0 |
73 |
|
2.r. |
Old World Monkeys |
21 |
61 |
0 |
0 |
0 |
0 |
0 |
0 |
82 |
|
2.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.t. |
Other Mammals |
202 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
202 |
|
2.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.v. |
Other birds |
51806 |
17171 |
4 |
20684 |
0 |
395 |
830 |
0 |
90890 |
|
2.w. |
Reptiles |
108 |
0 |
0 |
0 |
0 |
0 |
13 |
0 |
121 |
|
2.x. |
Amphibians |
788 |
0 |
0 |
0 |
0 |
0 |
82 |
0 |
870 |
|
2.y. |
Fish |
19503 |
0 |
0 |
0 |
3383 |
0 |
973 |
0 |
23859 |
|
2.z. |
TOTAL |
266485 |
81070 |
37560 |
52655 |
39696 |
9259 |
14331 |
0 |
501056 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns |
3.10 Other toxico-logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
3224 |
201 |
1499 |
0 |
0 |
2598 |
0 |
0 |
0 |
7522 |
|
3.b. |
Rats |
5838 |
4193 |
11700 |
48 |
0 |
1286 |
177 |
0 |
42 |
23284 |
|
3.c. |
Guinea-Pigs |
134 |
0 |
49 |
0 |
0 |
0 |
0 |
0 |
0 |
183 |
|
3.d. |
Hamsters |
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
|
3.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.f. |
Rabbits |
2222 |
634 |
1681 |
0 |
0 |
6 |
0 |
0 |
0 |
4543 |
|
3.g. |
Cats |
44 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
44 |
|
3.h. |
Dogs |
471 |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
519 |
|
3.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.l. |
Pigs |
26 |
0 |
0 |
0 |
0 |
0 |
162 |
0 |
0 |
188 |
|
3.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.y. |
Fish |
353 |
0 |
365 |
0 |
0 |
0 |
0 |
2665 |
0 |
3383 |
|
3.z. |
TOTAL |
12342 |
5076 |
15294 |
48 |
0 |
3890 |
339 |
2665 |
42 |
39696 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
16595 |
13267 |
47276 |
84369 |
11454 |
172961 |
|
4.b. |
Rats |
4070 |
11472 |
1554 |
20855 |
46 |
37997 |
|
4.c. |
Guinea-Pigs |
0 |
98 |
0 |
463 |
40 |
601 |
|
4.d. |
Hamsters |
0 |
9 |
0 |
263 |
240 |
512 |
|
4.e. |
Other Rodents |
0 |
27 |
0 |
619 |
0 |
646 |
|
4.f. |
Rabbits |
369 |
5 |
56 |
476 |
38 |
944 |
|
4.g. |
Cats |
0 |
0 |
0 |
6 |
39 |
45 |
|
4.h. |
Dogs |
61 |
0 |
0 |
28 |
269 |
358 |
|
4.i. |
Ferrets |
0 |
0 |
0 |
355 |
87 |
442 |
|
4.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
37 |
350 |
387 |
|
4.l. |
Pigs |
293 |
0 |
36 |
263 |
3784 |
4376 |
|
4.m. |
Goats |
106 |
0 |
0 |
75 |
4 |
185 |
|
4.n. |
Sheep |
32 |
0 |
0 |
271 |
467 |
770 |
|
4.o. |
Cattle |
0 |
0 |
0 |
129 |
997 |
1126 |
|
4.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.q. |
New World Monkeys |
0 |
9 |
0 |
64 |
0 |
73 |
|
4.r. |
Old World Monkeys |
0 |
0 |
0 |
72 |
0 |
72 |
|
4.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.v. |
Other birds |
0 |
0 |
0 |
1160 |
39694 |
40854 |
|
4.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.y. |
Fish |
0 |
148 |
210 |
1003 |
95 |
1456 |
|
4.z. |
TOTAL |
21526 |
25035 |
49132 |
110508 |
57604 |
263805 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
0 |
2725 |
0 |
1978 |
15087 |
1487 |
21277 |
||||
|
5.b. |
Rats |
0 |
4000 |
0 |
758 |
26194 |
68 |
31020 |
||||
|
5.c. |
Guinea-Pigs |
0 |
543 |
0 |
160 |
2400 |
1845 |
4948 |
||||
|
5.d. |
Hamsters |
0 |
0 |
0 |
0 |
2539 |
0 |
2539 |
||||
|
5.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.f. |
Rabbits |
0 |
1 |
0 |
0 |
1582 |
86 |
1669 |
||||
|
5.g. |
Cats |
27 |
0 |
0 |
0 |
58 |
0 |
85 |
||||
|
5.h. |
Dogs |
22 |
0 |
0 |
0 |
165 |
11 |
198 |
||||
|
5.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
60 |
2057 |
2117 |
||||
|
5.l. |
Pigs |
0 |
0 |
0 |
0 |
1610 |
676 |
2286 |
||||
|
5.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.n. |
Sheep |
2 |
0 |
0 |
0 |
10 |
2649 |
2661 |
||||
|
5.o. |
Cattle |
16 |
0 |
0 |
6 |
359 |
346 |
727 |
||||
|
5.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.v. |
Other birds |
75 |
0 |
60 |
0 |
15474 |
5079 |
20688 |
||||
|
5.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.y. |
Fish |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.z. |
TOTAL |
142 |
7269 |
60 |
2902 |
65538 |
14304 |
90215 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
4 |
0 |
0 |
0 |
6870 |
648 |
7522 |
||||
|
6.b. |
Rats |
77 |
0 |
0 |
0 |
22654 |
553 |
23284 |
||||
|
6.c. |
Guinea-Pigs |
4 |
0 |
0 |
0 |
57 |
122 |
183 |
||||
|
6.d. |
Hamsters |
0 |
0 |
0 |
0 |
30 |
0 |
30 |
||||
|
6.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.f. |
Rabbits |
0 |
0 |
0 |
0 |
4540 |
3 |
4543 |
||||
|
6.g. |
Cats |
0 |
0 |
0 |
0 |
44 |
0 |
44 |
||||
|
6.h. |
Dogs |
0 |
0 |
0 |
0 |
519 |
0 |
519 |
||||
|
6.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.l. |
Pigs |
0 |
0 |
0 |
0 |
13 |
175 |
188 |
||||
|
6.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.y. |
Fish |
77 |
0 |
0 |
0 |
2898 |
408 |
3383 |
||||
|
6.z. |
TOTAL |
162 |
0 |
0 |
0 |
37625 |
1909 |
39696 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Czech requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino-genicity |
7.8 Develop- mental toxicity |
7.9 Muta-genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
0 |
251 |
396 |
0 |
2020 |
0 |
40 |
106 |
2293 |
1026 |
360 |
0 |
1030 |
7522 |
|
7.b. |
Rats |
0 |
960 |
4486 |
391 |
0 |
0 |
3231 |
0 |
7844 |
553 |
4512 |
0 |
1307 |
23284 |
|
7.c. |
Guinea-Pigs |
0 |
0 |
114 |
18 |
49 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
183 |
|
7.d. |
Hamsters |
0 |
0 |
0 |
22 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
30 |
|
7.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.f. |
Rabbits |
0 |
0 |
508 |
249 |
0 |
186 |
428 |
0 |
0 |
0 |
2084 |
0 |
1088 |
4543 |
|
7.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
44 |
44 |
|
7.h. |
Dogs |
0 |
0 |
227 |
0 |
0 |
0 |
250 |
0 |
0 |
0 |
0 |
0 |
42 |
519 |
|
7.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.l. |
Pigs |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
175 |
188 |
|
7.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.y. |
Fish |
1198 |
421 |
1344 |
119 |
0 |
0 |
301 |
0 |
0 |
0 |
0 |
0 |
0 |
3383 |
|
7.z. |
TOTAL |
1198 |
1632 |
7088 |
799 |
2069 |
186 |
4250 |
106 |
10137 |
1579 |
6956 |
0 |
3696 |
39696 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta-genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
0 |
0406 |
03.645 |
0182 |
0832 |
028 |
02.490 |
0106 |
0 |
0673 |
0994 |
0 |
02.986 |
12342 |
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
0 |
034 |
0390 |
030 |
044 |
03 |
0120 |
0 |
0703 |
0184 |
03.568 |
0 |
0 |
5076 |
|
8.c. |
Products/substances used or intended to be used mainly in industry |
0365 |
0749 |
01.833 |
0465 |
01.193 |
0152 |
0288 |
0 |
07.141 |
0375 |
02.227 |
0 |
0506 |
15294 |
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
016 |
032 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
06 |
0120 |
03 |
0 |
03 |
0951 |
0 |
02.293 |
0305 |
0167 |
0 |
042 |
3890 |
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
0 |
077 |
0 |
0 |
0 |
0100 |
0 |
0 |
0 |
0 |
0 |
0162 |
339 |
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
0833 |
0421 |
0991 |
0119 |
0 |
0 |
0301 |
0 |
0 |
0 |
0 |
0 |
0 |
2665 |
|
8.i. |
Other toxicological or safety evaluations |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
042 |
0 |
0 |
0 |
42 |
|
8.j. |
TOTAL |
1198 |
1632 |
7088 |
799 |
2069 |
186 |
4250 |
106 |
10137 |
1579 |
6956 |
0 |
3696 |
39696 |
EN
|
|
EUROPEAN COMMISSION |
Brussels, 30.9.2010
SEC(2010) 1107 final
COMMISSION STAFF WORKING DOCUMENT
Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COM(2010) 511 final
COMMISSION STAFF WORKING DOCUMENT
Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
TABLE OF CONTENTS
I.INTRODUCTION4
II.DATA SUBMITTED AND GENERAL ASSESSMENT6
II.1.Data submitted by the Member States6
II.2.General assessment6
II.3.Structure of the Report8
PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2008 9
III.1.Results of EU Table 1: Species and number of animals9
III.2.Results of EU Table 1: Origin of animals used16
III.3.Results of EU Table 2: Purposes of the experiments19
III.4.Results of EU Table 3: Toxicological and safety evaluation by type of product/endpoint23
III.5.Results of EU Table 4: Animals used for studies of diseases26
III.6.Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine31
III.7.Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations34
III.8.Results of EU Table 7: Animals used in toxicity tests for toxicological and other safety evaluations37
III.9.Results of EU Table 8: Type of toxicity tests carried out for toxicological and other safety evaluations of products41
I.INTRODUCTION
The objective of this report is to present to the Council and the European Parliament, in accordance with Article 26 of Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes 1 , the statistical data on the number of animals used for experimental and other scientific purposes in the Member States of the EU.
The first two statistical reports drafted in accordance with the provisions of the above mentioned directive which were published in 1994 2 and 1999 3 , covering data on experimental animals collected in 1991 and 1996 respectively in the Member States, allowed only a limited amount of statistical analysis due to the absence of a consistent system of reporting the data. In 1997 an agreement was reached between the Commission and the competent authorities of the Member States to submit data for future reports using a format of eight harmonized tables. The third and fourth statistical reports published in 2003 4 and 2005 5 covering data collected in 1999 and 2002 were based on these agreed harmonized tables. This allowed a much wider interpretation of the results on the use of experimental animals in the EU. In spite of the progress made in the content of these two statistical reports, it ought to be stressed that there were some inconsistencies in the data submitted by the Member States and also that in all cases except the report of 2003, one Member State collected data from another year. The Fifth Statistical Report, published in 2007 6 , contained for the first time data collected in the 10 Member States which joined the EU in 2004. In the Sixth Statistical Report the complete set of standardized tables provided by all 27 Member States were successfully evaluated, although comparison of the results with previous reports was essentially qualitative owing to the addition of data from the new Member States.
This Report includes data submitted by Romania and Bulgaria, which joined the EU in 2007. It gives an overview of the number of animals used in the Member States for experimental purposes for the year 2008 with the exception of one Member State which provided data from 2007.
The Commission Staff Working Document accompanies the Report from the Commission to the Council and the European Parliament – Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union. The report summarizes the data and conclusions presented in this Staff Working Document.
II.DATA SUBMITTED AND GENERAL ASSESSMENT
II.1.Data submitted by the Member States
All 27 Member States submitted the data in the agreed EU format.
A quality control check on the set of data submitted for 2008 has been carried out and is essentially governed by four criteria based on certain relationships between the data in the different tables.
–The first of these relationships is the total number of animals used by species, column 1.2 of EU table 1, which is broken down into purposes of experiments in EU table 2. Thus, the totals of the Tables 1 and 2 should be identical.
–The second relationship concerns column 2.6 of EU table 2 'animals used for toxicological and other safety evaluation' which is broken down into types of products/endpoints in EU table 3; into Regulatory requirements in EU table 6; and into types of toxicological tests in EU table 7. Therefore, the total of column 2.6 must be equal to the totals of tables 3, 6, 7 and in addition table 8 'type of tests versus products' respectively.
–The third relationship is that the sum of column 2.4 and 2.5 of EU table 2 must be equal to the total of EU table 5.
–In the fourth relationship, the total of EU table 3 should be equal to the total of table 8.
The last criterion has shown obvious weaknesses when tested on the tables provided by the Member States and has lead to include an additional 5th quality check criterion.
–Fifth: each individual total in the total line of table 3 must be equal to each individual total in the total column of table 8 as the column headings are identical.
For this Sixth report all the above quality criteria have been fulfilled by the Member States. It is therefore considered that the data provided by the Member States affords a consistent base for a sound statistical analysis of all eight EU tables.
II.2.General assessment
Each Member State is requested, pursuant to Articles 13 of Directive 86/609/EEC, to submit to the Commission the statistical data on the animals used for experimental and other scientific purposes. The data for this report covers the year 2008 with the exception of France which provided data from 2007.
Council Resolution 86/C331/02 of the representatives of the Governments of the Member States of the European Communities, meeting within the Council of 24 November 1986 regarding the protection of animals used for experimental and other scientific purposes 7 allows the use of animals in experiments for education and training, but where the purposes of such experiments are not covered by the Directive, Member States will according to the Resolution apply national provisions which are no less severe than those of the Directive. Therefore, a number of Member States have also included animals covered by the Resolution in the report.
The first part of this report aims at providing a comprehensive overview on the numbers of animals used for various experimental purposes in the Community in 2008. The purposes of the use of animals have been analysed, and some of these purposes have been broken down further into more precise parameters. It also considers different legislative requirements regarding the use of experimental animals and the type of testing carried out on different species.
As the two newest Member States, Bulgaria and Romania, have submitted data for the first time, it is in principle not possible to draw accurate quantitative conclusions on the evolution of the use of animals for experimental purposes in the EU by comparing data with those of the previous reports. However, as their total use amounts to less than 1% of the total number of animals used in 2008, some comparisons in trends have been attempted, and significant changes in use have been highlighted in the report.
The second part of this report provides the individual data from the Member States together with their respective comments and interpretations.
In the EU, the total number of animals used for experimental and other scientific purposes in 2008 in the Member States amounts to just over 12 million (with data from France from 2007).
As in previous reports rodents together with rabbits represent more than 80% of the total number of animals used in the EU. Mice are by far the most commonly used species accounting for 59% of the total use, followed by rats with 17%.
The second most used group of animals was, as in previous years, cold-blooded animals which represent almost 10%. The third largest group of animals used was birds with a little over 6% of the total use.
As stated in the previous two statistical reports no Great Apes were used in experiments in the EU in 2008.
II.3.Structure of the Report
The report is divided into two parts:
A A global compilation and overview for the European Union of the statistical data of the Member States for 2008.
A consolidated table has been computed on the basis of the data submitted by the Member States for each EU table and is presented at the end of each chapter. Each table is illustrated by a graphical presentation to give a more readable overview of the EU situation.
Similarly to results of the Report of 2005, for which France submitted statistical data for 2004, the data analysed for this Report includes statistical data from the year 2007 from France. Therefore, the totals used in this report are a mixture of years. Comparisons were nevertheless made on this basis since no other data were available.
The reader is invited to take note that the numbering of tables and graphical presentation in Part A of the report are linked to the numbers of the EU tables and not to the numbering of the chapters of the report.
B
The data submitted by each Member State with a summary of the Member State’s comments.
PART A: COMPILATION AND OVERVIEW OF THE DATA OF 2008
III.1.Results of EU Table 1: Species and number of animals
Two types of information can be drawn from the data submitted by the Member States in EU Table 1. The first relates to the total number of animals subdivided into 25 species used by the Member States. The second type of information relates to the place of origin of the animals used for experimental or other scientific purposes.
III.1.1.The data on the total number of animals used in the MS
Table 1.1 of this report presents the consolidated data on the number of animals used for experimental purposes, by species, submitted by 27 Member States. Whereas in previous years Malta had not used animals for scientific purposes, in 2008 this country reported animal use for the first time.
The total number of animals used in 2008 in the 27 Member States amounts to 12.0 million animals. It is important to note that the number of animals used in the new Member States who joined the EU in 2008 (Bulgaria and Romania) represents not even 1,0% of the total number of animals used in the EU 27.
III.1.2.Treatment and interpretation of the data of Table 1.1
In order to present an overall evaluation and subsequently a graphical analysis, animal species were grouped. The result of this exercise is presented in Table 1.2 at the end of this chapter. This grouping in Table 1.2 allows an overview of the species used and is illustrated in Figure 1.1.
It should also be pointed out that re-used animals are not included in the figures so that animals are not counted twice.
Rodents together with rabbits represent more than 80% of the total number of animals used. Mice (59,3%) and rats (17,6%) are by far the most commonly used species.
The second most used group is represented by cold-blooded animals namely reptiles, amphibians and fish at 9,6%.
Birds is the next highest animal group used for experimental purposes at 6,3%.
The Artiodactyla and Perissodactyla group including horses, donkeys and crossbreeds (Perrissodactyla), pigs, goats, sheep and cattle (Artiodactyla) represents 1,4% of the total number of animals used in the Member States.
Carnivores represent 0,3% of the total number of animals used and non-human primates represent 0,08% of the animals used in 2008.
III.1.3.Comparison with the data of the previous reports
In this chapter, and the following chapters where comparisons are addressed, the reader is invited to take note of the fact that in 1996, in 2002, in 2005 and for this report France has reported data respectively for 1997, 2001, 2004 and 2007 which does not allow a rigorous comparison between data reported for each year. Nevertheless, assuming that fluctuations in the annual numbers of animals used per species in a country are limited, it is possible to make semi-quantitative estimates of the observed trends by comparing changes in proportions of use, expressed as a percentage.
Comparison between proportions of classes of animals used in 1996, 1999, 2002, 2005 and 2008
|
|
1996(*) |
1999 |
2002(**) |
2005(***) |
2008(****) |
|
% Rodents-rabbits |
81,3 |
86,9 |
78,0 |
77,5 |
82,2, |
|
% Cold-blooded animals |
12,9 |
6,6 |
15,4 |
15, |
9,6 |
|
% Birds |
4,7 |
5 |
5,4 |
6,4 |
|
|
% Artio and Perissodactyla |
1,2 |
1,2 |
1,1 |
1,4 |
(*) 14 Member States reporting for 1996, one for 1997
(**) 14 Member States reporting for 2002, one for 2001
(***) 24 Member States reporting for 2005, one for 2004
(****) 27 Member States reporting for 2008, one for 2007
Overall, the percentage of rodents and rabbits shows some fluctuation, but remains close to 80%. For cold-blooded animals the proportion used in 1996, in 2002 and 2005 is between 10 to 15%. In 2008 the use of cold-blooded animals has dropped considerably to below 10%. However, in 1999 a much lower percentage of 6,6% was observed.
Birds representing the third largest percentage of animals used, seems to be in constant increase over the years from 4 to 6,4%. The group of horses, donkeys and cross-bred animals (artiodactyla) and pigs, goats, sheep and cattle (perissodactyla) fluctuates at around 1%.
Contrary to what would have been expected, the effect of the inclusion of the data of new Member States since 2005 i.e. Bulgaria and Romania, did not lead to an increase in the total number of animals, on the contrary, there is a decrease of more than 116,500 animals.
Table 1.0 contains a comparison of the change that has taken place since 2008 for each species, expressed in number of animals per species, between EU 27 (data from 2008) and EU 25 (data from 2005) (first three columns) and in percentage per species (fourth column). The second half is a comparison between EU 25 (data of 2008 without Romania and Bulgaria)
Table 1.0 : Changes in species number and proportion between 2005 and 2008
|
Species |
Number of animals
2005 |
Number of animals
2008 |
Change since 2005 |
% change by species |
Change since 2005 |
Number of animals
2008 excl. RO,BG |
% change by species |
|
1.a Mice (Mus musculus) |
6430346 |
7122188 |
691842 |
9,71 |
630992 |
7061338 |
8,94 |
|
1.b Rats (Rattus norvegicus) |
2336032 |
2121727 |
-214305 |
-10,10 |
-223989 |
2112043 |
-10,61 |
|
1.c Guinea-Pigs (Cavia porcellus) |
257307 |
220985 |
-36322 |
-16,44 |
-46774 |
210533 |
-22,22 |
|
1.d Hamsters (Mesocricetus ) |
31535 |
32739 |
1204 |
3,68 |
759 |
32294 |
2,35 |
|
1.e Other Rodents (other Rodentia) |
64474 |
39506 |
-24968 |
-63,20 |
-24968 |
39506 |
-63,20 |
|
1.f Rabbits (Oryctolagus cuniculus) |
312681 |
333213 |
20532 |
6,16 |
17514 |
330195 |
5,30 |
|
1.g Cats (Felis catus) |
3898 |
4088 |
190 |
4,65 |
179 |
4077 |
4,39 |
|
1.h Dogs (Canis familiaris) |
24119 |
21315 |
-2804 |
-13,16 |
-2819 |
21300 |
-13,23 |
|
1.i Ferrets (Mustela putorius furo) |
2690 |
3208 |
518 |
16,15 |
518 |
3208 |
16,15 |
|
1.j Other Carnivores |
8711 |
2853 |
-5858 |
-205,33 |
-5858 |
2853 |
-205,33 |
|
1.k Horses, donkeys and cross breds (Equidae) |
5312 |
5976 |
664 |
11,11 |
633 |
5945 |
10,65 |
|
1.l Pigs (Sus) |
66305 |
92813 |
26508 |
28,56 |
26369 |
92674 |
28,45 |
|
1.m Goats (Capra) |
2146 |
3840 |
1694 |
44,11 |
1614 |
3760 |
42,93 |
|
1.n Sheep (Ovis) |
30021 |
30190 |
169 |
0,56 |
-212 |
29809 |
-0,71 |
|
1.o Cattle (Bos) |
36271 |
33952 |
-2319 |
-6,83 |
-2448 |
33823 |
-7,24 |
|
1.p Prosimians (Prosimia) |
677 |
1261 |
584 |
46,31 |
584 |
1261 |
46,31 |
|
1.q New World Monkeys (Ceboidea) |
1564 |
904 |
-660 |
-73,01 |
-660 |
904 |
-73,01 |
|
-1.r Old World Monkeys (Cercopithecoidea) |
8208 |
7404 |
-804 |
-10,86 |
-804 |
7404 |
-10,86 |
|
1.s Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t Other Mammals (other Mammalia) |
9950 |
5704 |
-4246 |
-74,44 |
-4246 |
5704 |
-74,44 |
|
1.u Quail (Coturnix coturnix) |
9246 |
9626 |
380 |
3,95 |
371 |
9617 |
3,86 |
|
1.v Other birds (other Aves) |
649813 |
754485 |
104672 |
13,87 |
101999 |
751812 |
13,57 |
|
1.w Reptiles (Reptilia) |
2477 |
4101 |
1624 |
39,60 |
1624 |
4101 |
39,60 |
|
1.x Amphibians (Amphibia) |
74620 |
61789 |
-12831 |
-20,77 |
-17631 |
56989 |
-30,94 |
|
1.y Fish (Pisces) |
1749178 |
1087155 |
-662023 |
-60,89 |
-662073 |
1087105 |
-60,90 |
|
1.z TOTAL |
12117583 |
12001022 |
-116561 |
-0,97 |
-209328 |
11908255 |
-1,76 |
There is an increase in the number of mice used since 2005 of 691,842 which is 9,71% of the total number of mice used in 2008 and a decrease for rats and fish. The largest change in 2008, increase in the use of mice, is almost entirely compensated for by the decrease in the use of fish.
The total number of pigs, goats, prosimians, and reptiles has increased by between 28 - 46%.
The total number of rats, guinea-pigs, other rodents, dogs, cattle and other mammals as well as amphibians and fish used has decreased substantially since the last report. When expressed in percentages these decreases range from more than 70% to around 10%.
The largest percentile change has, however, been noted in the decrease of the use of other carnivores. However, these species are not used in great numbers (from 8,711 to 2,853). There is also a large decrease of 75% in the total number of 'other mammals'.
It is also worth noting the large decrease in the use of new world monkeys of 73% as well as a decrease of 11% of old world monkeys. Prosimian use overall, however, has increased by 46%.
For species used in greater numbers, significant increases occurred in 2008 for mice, rabbits, pigs and 'other birds' where percentage changes ranged from 5% to 28%.
The following animals which are normally used in fewer numbers show an increase in use: ferrets (16%), horses, donkeys and cross-breeds (11%), goats (44%) and reptiles (39%).
As in 2002 and 2005, no great apes were used for experimental or other scientific purposes in 2008.
Member States provided examples of the type of species covered by category 'other' as follows:
Other rodents: gerbils, old world jerboas (Jaculus jaculus); chinchillas, beavers, ground squirrels, hamsters, grey dwarf hamsters (Cricetulus migratorius) and different species of mice.
Other carnivores: wild-life species used for zoological and ecological studies e.g. foxes, badgers, seals, otters and fitchew.
Other mammals: boars, bats and shrews, llamas, moles, European bison and red deer.
Other birds: mainly Japanese Quail (coturnix japonica) and bob-white quail, poultry species, and zebra finches, canaries, parakeets, parrots and farmed avian species for example, chickens.
In the three columns in the second half of the table, the addition of data from Bulgaria, Romania has virtually no effect on the proportional changes between the species.
Romania has little effect on the proportional changes between the species ranging from no change to very marginal variations per species. However, there is a net decrease of guinea pigs – 4%, and 10% for amphibians, when data from Bulgaria and Romania are excluded.
Table 1.1: Total number of animals used for experimental purposes in the EU Member States
Data of 2008 (*)
|
Species |
AT |
BE |
BG |
CY |
CZ |
DK |
ET |
FI |
FR |
DE |
EL |
HU |
IE |
IT |
LV |
LT |
LU |
MT |
NL |
PL |
PT |
RO |
SP |
SK |
SL |
SE |
UK |
Totals |
|
1a. Mice |
177544 |
480681 |
16265 |
2114 |
54776 |
168164 |
28754 |
78446 |
1561809 |
1314493 |
19786 |
158799 |
71224 |
553000 |
6912 |
3827 |
3280 |
50 |
237681 |
123897 |
39811 |
44585 |
543680 |
6942 |
10313 |
203112 |
1212243 |
7122188 |
|
1b. Rats |
9928 |
108580 |
4513 |
0 |
21531 |
75850 |
5268 |
26058 |
392773 |
390853 |
4367 |
89375 |
11741 |
230347 |
2407 |
1194 |
430 |
44 |
105780 |
45824 |
6571 |
5171 |
175325 |
9692 |
1675 |
53141 |
343289 |
2121727 |
|
1c. Guinea-Pigs |
3284 |
36554 |
3845 |
0 |
1902 |
5343 |
22 |
215 |
46030 |
35870 |
45 |
9743 |
91 |
13875 |
32 |
93 |
100 |
0 |
6062 |
6495 |
152 |
6607 |
12620 |
982 |
7 |
1766 |
29250 |
220985 |
|
1d. Hamsters |
693 |
2124 |
182 |
0 |
251 |
4 |
120 |
302 |
12063 |
7061 |
0 |
215 |
68 |
717 |
0 |
0 |
0 |
0 |
3358 |
312 |
29 |
263 |
1262 |
0 |
0 |
864 |
2851 |
32739 |
|
1e.Other Rodents |
47 |
1055 |
1233 |
1760 |
0 |
3142 |
3594 |
8392 |
356 |
1235 |
0 |
2439 |
11966 |
251 |
45 |
0 |
2033 |
1958 |
39506 |
|||||||||
|
1f. Rabbits |
18761 |
42025 |
813 |
0 |
6304 |
2931 |
630 |
814 |
96427 |
97938 |
1498 |
8134 |
204 |
9706 |
48 |
199 |
20 |
0 |
7418 |
3086 |
99 |
2205 |
19626 |
679 |
307 |
1332 |
12009 |
333213 |
|
1g. Cats |
2 |
78 |
11 |
0 |
45 |
154 |
0 |
1848 |
798 |
4 |
40 |
295 |
26 |
0 |
0 |
0 |
0 |
253 |
83 |
0 |
100 |
18 |
0 |
149 |
184 |
4088 |
||
|
1h. Dogs |
41 |
788 |
15 |
0 |
552 |
271 |
0 |
54 |
4131 |
4450 |
44 |
686 |
557 |
943 |
0 |
0 |
0 |
0 |
1244 |
230 |
0 |
1046 |
4 |
0 |
1982 |
4277 |
21315 |
|
|
1i. Ferrets |
14 |
324 |
0 |
0 |
122 |
117 |
0 |
800 |
55 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
472 |
0 |
0 |
287 |
0 |
0 |
39 |
978 |
3208 |
|||
|
1j.Other Carnivores |
0 |
0 |
45 |
101 |
0 |
761 |
0 |
410 |
0 |
0 |
0 |
10 |
520 |
5 |
0 |
53 |
948 |
2853 |
||||||||||
|
.k. horses, donkeys & cross-breeds |
47 |
62 |
17 |
378 |
54 |
0 |
37 |
652 |
584 |
1 |
40 |
144 |
46 |
0 |
2562 |
529 |
6 |
14 |
90 |
0 |
423 |
290 |
5976 |
|||||
|
1l. Pigs |
5086 |
2969 |
137 |
2013 |
6863 |
819 |
8768 |
12361 |
624 |
1193 |
224 |
3607 |
80 |
0 |
11729 |
11742 |
222 |
2 |
15121 |
22 |
3 |
1973 |
7255 |
92813 |
||||
|
1m. Goats |
39 |
195 |
80 |
174 |
107 |
0 |
1159 |
531 |
24 |
92 |
41 |
0 |
229 |
300 |
372 |
5 |
0 |
5 |
487 |
3840 |
||||||||
|
1n. Sheep |
142 |
356 |
250 |
1148 |
88 |
571 |
3573 |
4638 |
68 |
200 |
456 |
469 |
0 |
3486 |
2217 |
28 |
131 |
2386 |
9 |
4 |
152 |
9818 |
30190 |
|||||
|
1o. Cattle |
574 |
657 |
126 |
799 |
939 |
0 |
300 |
3206 |
6252 |
72 |
93 |
4019 |
462 |
0 |
2236 |
7540 |
10 |
3 |
1091 |
0 |
1379 |
4194 |
33952 |
|||||
|
1p. Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
718 |
543 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1261 |
|||
|
1q.N W Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
233 |
305 |
0 |
5 |
18 |
0 |
0 |
0 |
0 |
73 |
0 |
0 |
8 |
0 |
0 |
0 |
262 |
904 |
|||
|
1r.O W Monkeys |
0 |
41 |
0 |
0 |
80 |
0 |
0 |
1797 |
1415 |
0 |
1 |
344 |
0 |
0 |
0 |
0 |
82 |
0 |
0 |
517 |
0 |
0 |
35 |
3092 |
7404 |
|||
|
1s. Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
..t.Other Mammals |
0 |
151 |
1774 |
243 |
84 |
0 |
541 |
16 |
32 |
151 |
0 |
202 |
1246 |
28 |
21 |
0 |
263 |
952 |
5704 |
|||||||||
|
1u. Quail |
14 |
431 |
0 |
0 |
0 |
0 |
0 |
1548 |
1803 |
0 |
13 |
249 |
0 |
0 |
0 |
0 |
0 |
5100 |
9 |
138 |
120 |
0 |
201 |
0 |
9626 |
|||
|
1v. Other birds |
1367 |
17151 |
1477 |
148722 |
2820 |
5568 |
156814 |
53986 |
88 |
32554 |
582 |
32241 |
40 |
0 |
90890 |
27391 |
160 |
1196 |
52104 |
696 |
129 |
3432 |
125077 |
754485 |
||||
|
1w. Reptiles |
17 |
374 |
1012 |
221 |
317 |
758 |
192 |
108 |
454 |
0 |
121 |
248 |
0 |
170 |
109 |
4101 |
||||||||||||
|
1x. Amphibians |
277 |
2388 |
4800 |
3016 |
293 |
34 |
9451 |
10815 |
200 |
1182 |
2432 |
149 |
0 |
870 |
1221 |
704 |
0 |
641 |
23316 |
61789 |
||||||||
|
1y. Fish |
2579 |
28386 |
50 |
54836 |
31245 |
21078 |
20228 |
67496 |
1200 |
2077 |
23198 |
13955 |
0 |
600 |
23859 |
25941 |
3800 |
71098 |
25 |
0 |
211459 |
484045 |
1087155 |
|||||
|
1z.TOTAL |
220456 |
725370 |
32581 |
2114 |
300713 |
297568 |
34794 |
138600 |
2328380 |
2021782 |
28021 |
304922 |
112835 |
864318 |
9399 |
5582 |
3830 |
694 |
501056 |
275888 |
50888 |
60186 |
897859 |
19260 |
12438 |
484604 |
2266884 |
12001022 |
(*) France is reporting for 2007
Table 1.2: Classes of animals used for experimental purposes in the EU Member States
Data of 2008 (*)
|
Species |
AT |
BE |
BG |
CY |
CZ |
DK |
ET |
FI |
FR |
DE |
EL |
HU |
IE |
IT |
LV |
LT |
LU |
MT |
NL |
PL |
PT |
RO |
SP |
SK |
SL |
SE |
UK |
Totals |
|
Mice |
177544 |
480681 |
16265 |
2114 |
54776 |
168164 |
28754 |
78446 |
1561809 |
1314493 |
19786 |
158799 |
71224 |
553000 |
6912 |
3827 |
3280 |
50 |
237681 |
123897 |
39811 |
44585 |
543680 |
6942 |
10313 |
203112 |
1212243 |
7122188 |
|
Rats |
9928 |
108580 |
4513 |
0 |
21531 |
75850 |
5268 |
26058 |
392773 |
390853 |
4367 |
89375 |
11741 |
230347 |
2407 |
1194 |
430 |
44 |
105780 |
45824 |
6571 |
5171 |
175325 |
9692 |
1675 |
53141 |
343289 |
2121727 |
|
Guinea-Pigs |
3284 |
36554 |
3845 |
0 |
1902 |
5343 |
22 |
215 |
46030 |
35870 |
45 |
9743 |
91 |
13875 |
32 |
93 |
100 |
0 |
6062 |
6495 |
152 |
6607 |
12620 |
982 |
7 |
1766 |
29250 |
220985 |
|
Hamsters + other rodents |
740 |
3179 |
182 |
0 |
1484 |
1764 |
120 |
3444 |
15657 |
15453 |
0 |
571 |
68 |
1952 |
0 |
0 |
0 |
0 |
5797 |
12278 |
29 |
263 |
1513 |
45 |
0 |
2897 |
4809 |
72245 |
|
Rabbits |
18761 |
42025 |
813 |
0 |
6304 |
2931 |
630 |
814 |
96427 |
97938 |
1498 |
8134 |
204 |
9706 |
48 |
199 |
20 |
0 |
7418 |
3086 |
99 |
2205 |
19626 |
679 |
307 |
1332 |
12009 |
333213 |
|
Cold-blooded animals (1) |
2873 |
31148 |
4850 |
0 |
58864 |
31759 |
0 |
21429 |
30437 |
78503 |
1400 |
3367 |
23198 |
16841 |
0 |
149 |
0 |
600 |
24850 |
27410 |
3800 |
0 |
71802 |
25 |
0 |
212270 |
507470 |
1153045 |
|
Birds (2) |
1381 |
17582 |
1477 |
0 |
148722 |
2820 |
0 |
5568 |
158362 |
55789 |
88 |
32567 |
582 |
32490 |
0 |
40 |
0 |
0 |
90890 |
32491 |
160 |
1205 |
52242 |
816 |
129 |
3633 |
125077 |
764111 |
|
Artio+perissodactyla (3) |
5888 |
4239 |
610 |
0 |
4512 |
8051 |
0 |
1727 |
17358 |
24366 |
789 |
1618 |
4843 |
4625 |
0 |
80 |
0 |
0 |
20242 |
22328 |
266 |
150 |
19060 |
36 |
7 |
3932 |
22044 |
166771 |
|
Carnivores |
57 |
1190 |
26 |
0 |
764 |
643 |
0 |
815 |
6779 |
5713 |
48 |
726 |
852 |
969 |
0 |
0 |
0 |
0 |
1979 |
833 |
0 |
0 |
1438 |
22 |
0 |
2223 |
6387 |
31464 |
|
Prosimians+monkeys +apes |
0 |
41 |
0 |
0 |
80 |
0 |
0 |
0 |
2748 |
2263 |
0 |
6 |
0 |
362 |
0 |
0 |
0 |
0 |
155 |
0 |
0 |
0 |
525 |
0 |
0 |
35 |
3354 |
9569 |
|
Other mammals |
0 |
151 |
1774 |
243 |
84 |
0 |
541 |
16 |
32 |
151 |
0 |
202 |
1246 |
28 |
21 |
0 |
263 |
952 |
5704 |
|||||||||
|
TOTAL |
220456 |
725370 |
32581 |
2114 |
300713 |
297568 |
34794 |
138600 |
2328380 |
2021782 |
28021 |
304922 |
112835 |
864318 |
9399 |
5582 |
3830 |
694 |
501056 |
275888 |
50888 |
60186 |
897859 |
19260 |
12438 |
484604 |
2266884 |
12001022 |
|
Species % |
AT |
BE |
BG |
CY |
CZ |
DK |
ET |
FI |
FR |
DE |
EL |
HU |
IE |
IT |
LV |
LT |
LU |
MT |
NL |
PL |
PT |
RO |
SP |
SK |
SL |
SE |
UK |
Totals |
|
|
Mice |
80,53 |
66,27 |
49,92 |
100,00 |
18,22 |
56,51 |
82,64 |
56,60 |
67,08 |
65,02 |
70,61 |
52,08 |
63,12 |
63,98 |
73,54 |
68,56 |
85,64 |
7,20 |
47,44 |
44,91 |
78,23 |
74,08 |
60,55 |
36,04 |
82,92 |
41,91 |
53,48 |
59,35 |
|
|
Rats |
4,50 |
14,97 |
13,85 |
0,00 |
7,16 |
25,49 |
15,14 |
18,80 |
16,87 |
19,33 |
15,58 |
29,31 |
10,41 |
26,65 |
25,61 |
21,39 |
11,23 |
6,34 |
21,11 |
16,61 |
12,91 |
8,59 |
19,53 |
50,32 |
13,47 |
10,97 |
15,14 |
17,68 |
|
|
Guinea-Pigs |
1,49 |
5,04 |
11,80 |
0,00 |
0,63 |
1,80 |
0,06 |
0,16 |
1,98 |
1,77 |
0,16 |
3,20 |
0,08 |
1,61 |
0,34 |
1,67 |
2,61 |
0,00 |
1,21 |
2,35 |
0,30 |
10,98 |
1,41 |
5,10 |
0,06 |
0,36 |
1,29 |
1,84 |
|
|
Hamsters + other rodents |
0,34 |
0,44 |
0,56 |
0,00 |
0,49 |
0,59 |
0,34 |
2,48 |
0,67 |
0,76 |
0,00 |
0,19 |
0,06 |
0,23 |
0,00 |
0,00 |
0,00 |
0,00 |
1,16 |
4,45 |
0,06 |
0,44 |
0,17 |
0,23 |
0,00 |
0,60 |
0,21 |
0,60 |
|
|
Rabbits |
8,51 |
5,79 |
2,50 |
0,00 |
2,10 |
0,98 |
1,81 |
0,59 |
4,14 |
4,84 |
5,35 |
2,67 |
0,18 |
1,12 |
0,51 |
3,57 |
0,52 |
0,00 |
1,48 |
1,12 |
0,19 |
3,66 |
2,19 |
3,53 |
2,47 |
0,27 |
0,53 |
2,78 |
|
|
Cold-blooded animals (1) |
1,30 |
4,29 |
14,89 |
0,00 |
19,57 |
10,67 |
0,00 |
15,46 |
1,31 |
3,88 |
5,00 |
1,10 |
20,56 |
1,95 |
0,00 |
2,67 |
0,00 |
86,46 |
4,96 |
9,94 |
7,47 |
0,00 |
8,00 |
0,13 |
0,00 |
43,80 |
22,39 |
9,61 |
|
|
Birds (2) |
0,63 |
2,42 |
4,53 |
0,00 |
49,46 |
0,95 |
0,00 |
4,02 |
6,80 |
2,76 |
0,31 |
10,68 |
0,52 |
3,76 |
0,00 |
0,72 |
0,00 |
0,00 |
18,14 |
11,78 |
0,31 |
2,00 |
5,82 |
4,24 |
1,04 |
0,75 |
5,52 |
6,37 |
|
|
Artio+perissodactyla (3) |
2,67 |
0,58 |
1,87 |
0,00 |
1,50 |
2,71 |
0,00 |
1,25 |
0,75 |
1,21 |
2,82 |
0,53 |
4,29 |
0,54 |
0,00 |
1,43 |
0,00 |
0,00 |
4,04 |
8,09 |
0,52 |
0,25 |
2,12 |
0,19 |
0,06 |
0,81 |
0,97 |
1,39 |
|
|
Carnivores |
0,03 |
0,16 |
0,08 |
0,00 |
0,25 |
0,22 |
0,00 |
0,59 |
0,29 |
0,28 |
0,17 |
0,24 |
0,76 |
0,11 |
0,00 |
0,00 |
0,00 |
0,00 |
0,39 |
0,30 |
0,00 |
0,00 |
0,16 |
0,11 |
0,00 |
0,46 |
0,28 |
0,26 |
|
|
Prosimians+monkeys+ apes |
0,00 |
0,01 |
0,00 |
0,00 |
0,03 |
0,00 |
0,00 |
0,00 |
0,12 |
0,11 |
0,00 |
0,00 |
0,00 |
0,04 |
0,00 |
0,00 |
0,00 |
0,00 |
0,03 |
0,00 |
0,00 |
0,00 |
0,06 |
0,00 |
0,00 |
0,01 |
0,15 |
0,08 |
|
|
Other mammals |
0,00 |
0,02 |
0,00 |
0,00 |
0,59 |
0,08 |
0,00 |
0,06 |
0,00 |
0,03 |
0,00 |
0,01 |
0,03 |
0,02 |
0,00 |
0,00 |
0,00 |
0,00 |
0,04 |
0,45 |
0,00 |
0,00 |
0,00 |
0,11 |
0,00 |
0,05 |
0,04 |
0,05 |
|
|
Mice |
|
||||||||||||||||||||||||||||
|
TOTAL |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
|
|
FR(*) France reporting for 2007 |
|||||||||||||||||||||||||||||
|
(1) reptiles + amphibians + fish |
|||||||||||||||||||||||||||||
|
(2) Quails and other birds |
|||||||||||||||||||||||||||||
|
(3) Horses, donkeys, and cross breeds + pigs + goats and sheep +cattle |
|||||||||||||||||||||||||||||
|
(4) Cats + dogs + ferrets + other carnivores |
|||||||||||||||||||||||||||||
III.2.Results of EU Table 1: Origin of animals used
III.2.1.The data on the origin of the species
The consolidated results of EU Table 1 on the origin of some selected species used for experimental purposes in the 27 Member States are reported in Table 1.3 at the end of this chapter. The consolidated table 1.3 only indicates species for which the origin must be reported.
In addition, EU Table 1.3 contains information on the number of animals re-used in experiments.
III.2.2.Treatment and interpretation of the data
The data of column 1.3 and 1.4 of Table 1.3 of this report have been grouped to represent animals coming from the European Union.
Figure 1.2 represents the percentage of animals from the reported origin versus the species.
The chart shows clearly that the majority of the species originated from EU countries. However, certain species such as cats, dogs and ferrets and old world monkeys are also of non-European origin.
III.2.3.Comparison with data of the previous report
The general pattern on the origin of the species is quite similar to that observed in previous reports. It should be noted however, that for the first time in 2005 the prosimians were all of EU origin and remain so for this report. A similar trend can also be observed with the new world monkeys where almost all originate from either EU Member States or countries which are a party to the Council of Europe Convention ETS 123. Finally, also old world monkeys coming from the EU increased from about 26% in 2005 to more than 50% in 2008. On the other hand the number of cats of EU origin also increased whereas dogs and ferrets of non-European origin have remained unchanged since the last report.
Table 1.3: Number of animals used in relation to their place of origin
Data of 2008 (*)
|
1.1Species |
1.2. Total |
1.3. Animals coming from registered breeding or supplying establishments within the reporting country |
1.4. Animals coming from elsewhere in the EC |
1.5. Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6. Animals coming from other origins |
1.7. Re-used animals |
||||
|
1.a. Mice (Mus musculus) |
7122188 |
6042205 |
900230 |
21382 |
158371 |
3768 |
||||
|
1.b. Rats (Rattus norvegicus) |
2121727 |
1761785 |
329385 |
9844 |
20713 |
3035 |
||||
|
1.c. Guinea-Pigs (Cavia porcellus) |
220985 |
161973 |
56167 |
2051 |
792 |
962 |
||||
|
1.d. Hamsters (Mesocricetus ) |
32739 |
24999 |
5476 |
1074 |
1190 |
54 |
||||
|
1.f. Rabbits (Oryctolagus cuniculus) |
333213 |
315006 |
14753 |
364 |
3087 |
15958 |
||||
|
1.g. Cats (Felis catus) |
4088 |
2306 |
726 |
14 |
1042 |
1181 |
||||
|
1.h. Dogs (Canis familiaris) |
21315 |
12467 |
2885 |
309 |
5654 |
4178 |
||||
|
1.i. Ferrets (Mustela putorius furo) |
3208 |
1847 |
442 |
0 |
919 |
64 |
||||
|
1.p. Prosimians (Prosimia) |
1261 |
718 |
543 |
0 |
0 |
33 |
||||
|
1.q. New World Monkeys (Ceboidea) |
904 |
816 |
83 |
5 |
0 |
346 |
||||
|
1.r. Old World Monkeys (Cercopithecoidea) |
7404 |
3213 |
850 |
5 |
3336 |
1509 |
||||
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
1.u. Quail (Coturnix coturnix) |
9626 |
7824 |
1500 |
0 |
302 |
0 |
||||
|
1.z. TOTAL |
9878658 |
8335159 |
1313040 |
35048 |
195406 |
|||||
|
* France: data of 2007 |
||||||||||
|
Note 1: Column 1.5 concerns only those member countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling this column |
||||||||||
|
Note 2: Only species for which the origin has to be reported are included in this table |
||||||||||
|
Note 3: The number of re-used animals in column 1.7 should be excluded from the total in column 1.2. |
||||||||||
III.3.Results of EU Table 2: Purposes of the experiments
III.3.1.The data on purposes of the experiments
The consolidated data on purposes of the experiments of the 27 Member States are presented in Table 2.1 at the end of this chapter.
III.3.2.Treatment and interpretation of the data
Table 2.2 presents the results of the consolidated data of the purposes of the procedures carried out in the 27 Member States in 2008. In order to facilitate the presentation of results some species and some purposes were grouped in Table 2.2.
The percentage of the number of animals used for selected purposes is presented in Figure 2.1.
More than 60% of animals were used in research and development for human medicine, veterinary medicine, dentistry and in fundamental biological studies.
Production and quality control of products and devices in human medicine, veterinary medicine and dentistry required the use of 14,9% of the total number of animals.
Toxicological and other safety evaluation represents 8,7% of the total number of animals used for experimental purposes.
Other purposes of procedures represents 12% of the total number of animals and covers a wide range of experiments such as virology, immunology for production of monoclonal and polyclonal antibodies, physiology of foetal-maternal interaction in mouse gene transgensis, oncological treatment, pharmaceutical research and development, combined drug testing and genetics.
III.3.3.Comparison with the data of the previous report
The comparison aims to detect changes in trends rather than draw formal conclusions. The most significant change that has taken place since 2005 is that the number of animals used for research and development for human medicine, dentistry and veterinary medicine has dropped sharply from 31% to 22,8% (in terms of animal numbers the decrease is from 3,746,028 to 2,733,706). To be noted in particular is the significant reduction of more than 800,000 cold-blooded animals since the last report of 2005. On the other hand, the percentage of animals used for fundamental biological research has increased from 33% to 38% (that is, from 4,035,470 to 4,575,054) as well as for 'other purposes', from 8% to 12%. It should be underlined that both fundamental biology and research and development in human and veterinary medicine are the areas using by far the highest number of animals for experimental purposes in the EU.
The number of animals used for toxicological and other safety evaluation has remained virtually unchanged since the last report and amounts to 8,7% of the total number of animals used for experimental purposes in the EU. This represents 1,042,153 animals.
In general the number of animals used for production and quality control of devices for medicine, veterinary medicine and dentistry has also remained unchanged since 2005. However, regarding the use by species, the use of mice and rabbits has increased substantially for production and quality control of products and devices for human medicine and dentistry. One Member State indicated that funding had been made available for pre-clinical trials for human medicine, which lead to an increase in use of experimental animals.
Another Member State using a large number of rabbits for production and quality control of veterinary medicine indicated that the laboratory responsible for that increase had reported the data in the wrong column, that is, they should have been reported under production and quality control of human medicine and dentistry rather than for products and devices for veterinary medicine. The increase was due to the production of polyclonal antibodies to improve transplant in human medicine. However, it was no longer possible to correct the error in the consolidated report.
Regarding increases in other purposes of use, there is a substantial increase in the use of mice, pigs and birds for 'fundamental biological research' and in 'other experiments'.
Several Member States confirmed that the increase in the use of mice for fundamental biological research is attributed to the new research possibilities offered by the transgenic species. These animal models are being used both for human and animal health studies. An increase was also reported for the purpose of experiments in anatomy and developmental biology, physiology, genetics and cancer research, and for immunology and microbiology.
There are several reasons for the increase in the use of pigs in ‘fundamental biological’ and also in ‘other studies’. One Member State using a large number of pigs for fundamental biological studies and for other procedures indicated that in recent years funding for projects relating to cardiovascular research has increased significantly. The same applies in the case of experimental surgery which is taking place in many hospitals in the same Member State. Another area using an increased number of pigs relates to pig disease studies, including for example the observation of vaccine effectiveness. It was reported that the increase was also due to fundamental research on pigs’ enzymes and digestive functions, and because the tissues and organs of transgenic pigs are used for transplants in humans.
The large number of birds used for fundamental biological research in one Member State was due to a campaign of bird ringing. The increase of the number of birds used for 'other experiments' was reported to be due to parasitology/immunology studies and to the development of genetically modified birds.
Table 2.2: Number of animals used for selected purposes versus species
|
Species |
Biological studies of a fundamental nature |
Research,development and quality control of products and devices for human medicine and dentistry and for veterinary medicine |
Toxicological and other safety evaluations (including safety evaluation of products) |
Diagnosis of disease |
Education and training |
Other |
Total |
|
Mice |
3080775 |
2624856 |
398199 |
137578 |
82606 |
798174 |
7122188 |
|
Rats |
595542 |
1060290 |
294683 |
22997 |
59412 |
88803 |
2121727 |
|
Other rodents |
44240 |
195427 |
33858 |
3145 |
7826 |
8734 |
293230 |
|
Rabbits |
17813 |
212618 |
39987 |
3376 |
3326 |
56093 |
333213 |
|
Carnivores |
4804 |
11378 |
11964 |
1360 |
515 |
1443 |
31464 |
|
Artio+perissodactyla |
55080 |
56359 |
8996 |
4620 |
13134 |
28582 |
166771 |
|
Prosimians+monkeys+apes |
1213 |
1260 |
6507 |
153 |
10 |
426 |
9569 |
|
Other mammals |
5279 |
177 |
0 |
12 |
25 |
211 |
5704 |
|
Birds |
292895 |
247618 |
53477 |
8415 |
11444 |
150262 |
764111 |
|
Cold-blooded animals |
477413 |
113766 |
194482 |
3651 |
29159 |
334574 |
1153045 |
|
TOTAL |
4575054 |
4523749 |
1042153 |
185307 |
207457 |
1467302 |
12001022 |
Figure 2.2 presents the number of animals used for selected purposes by classes of species.
The highest number of mice and rats is attributed to fundamental biological studies and research, development and quality control of products and devices for medicine, dentistry and veterinary medicine. It is noteworthy that a high number of cold-blooded animals have been used for 'other purposes' as well as for 'biological studies of a fundamental nature'.
One can observe a significant reduction in the use of cold-blooded animals for research and development of devices for human and veterinary medicine and for dentistry since the last report of 2005.
Table 2.1: Number of animals used in experiments for selected purposes
Purposes versus species
data of 2008*
|
2.1.Species |
2.2.Biological studies of a fundamental nature |
2.3. Research and development of products and devices for human medicine and dentistry and for veterinary medicine(excluding toxicological and other safety evaluations counted in column 2.6) |
2.4. Production and quality control of products and devices for human medicine and dentistry |
2.5. Production and quality control of products and devices for veterinary medicine |
2.6. Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine |
2.7. Diagnosis of disease |
2.8. Education and training |
2.9. Other |
2.10. Total |
|
1.a. Mice (Mus musculus) |
3080775 |
1597381 |
856048 |
171427 |
398199 |
137578 |
82606 |
798174 |
7122188 |
|
1.b. Rats (Rattus norvegicus) |
595542 |
840909 |
181140 |
38241 |
294683 |
22997 |
59412 |
88803 |
2121727 |
|
1.c. Guinea-Pigs (Cavia porcellus) |
10632 |
44344 |
103852 |
17265 |
31883 |
1940 |
5804 |
5265 |
220985 |
|
1.d. Hamsters (Mesocricetus ) |
6994 |
8041 |
376 |
12513 |
1580 |
278 |
520 |
2437 |
32739 |
|
1.e. Other Rodents (other Rodentia) |
26614 |
9006 |
30 |
0 |
395 |
927 |
1502 |
1032 |
39506 |
|
1.f. Rabbits (Oryctolagus cuniculus) |
17813 |
29764 |
131031 |
51823 |
39987 |
3376 |
3326 |
56093 |
333213 |
|
1.g. Cats (Felis catus) |
560 |
1738 |
57 |
679 |
322 |
124 |
97 |
514 |
4091 |
|
1.h. Dogs (Canis familiaris) |
1814 |
4405 |
157 |
2070 |
11077 |
1111 |
362 |
316 |
21312 |
|
1.i. Ferrets (Mustela putorius furo) |
551 |
1287 |
564 |
8 |
269 |
45 |
56 |
428 |
3208 |
|
1.j. Other Carnivores (other Carnivora) |
1879 |
75 |
0 |
338 |
296 |
80 |
0 |
185 |
2853 |
|
1.k. Horses, donkeys and cross breds (Equidae) |
1402 |
728 |
224 |
2559 |
22 |
239 |
489 |
313 |
5976 |
|
1.l. Pigs (Sus) |
23531 |
22799 |
423 |
9001 |
8065 |
1452 |
8134 |
19408 |
92813 |
|
1.m. Goats (Capra) |
1098 |
721 |
93 |
26 |
43 |
90 |
422 |
1347 |
3840 |
|
1.n. Sheep (Ovis) |
9727 |
4098 |
6020 |
2149 |
409 |
1616 |
1243 |
4928 |
30190 |
|
1.o. Cattle (Bos) |
19322 |
3990 |
214 |
3314 |
457 |
1223 |
2846 |
2586 |
33952 |
|
1.p. Prosimians (Prosimia) |
568 |
0 |
0 |
0 |
543 |
150 |
0 |
0 |
1261 |
|
1.q. New World Monkeys (Ceboidea) |
235 |
235 |
33 |
0 |
270 |
0 |
0 |
131 |
904 |
|
1.r. Old World Monkeys (Cercopithecoidea) |
410 |
761 |
231 |
0 |
5694 |
3 |
10 |
295 |
7404 |
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. Other Mammals (other Mammalia) |
5279 |
86 |
28 |
63 |
0 |
12 |
25 |
211 |
5704 |
|
1.u. Quail (Coturnix coturnix) |
5520 |
57 |
0 |
0 |
2170 |
9 |
1575 |
295 |
9626 |
|
1.v. Other birds (other Aves) |
287375 |
77748 |
10593 |
159220 |
51307 |
8406 |
9869 |
149967 |
754485 |
|
1.w. Reptiles (Reptilia) |
3781 |
94 |
0 |
0 |
0 |
0 |
147 |
79 |
4101 |
|
1.x. Amphibians (Amphibia) |
32780 |
1914 |
0 |
0 |
291 |
202 |
12213 |
14389 |
61789 |
|
1.y. Fish (Pisces) |
440852 |
83525 |
20418 |
7815 |
194191 |
3449 |
16799 |
320106 |
1087155 |
|
1.z. TOTAL |
4575054 |
2733706 |
1311532 |
478511 |
1042153 |
185307 |
207457 |
1467302 |
12001022 |
(*) France is reporting for 2007
III.4.Results of EU Table 3: Toxicological and safety evaluation by type of product/endpoint
III.4.1.The data on toxicological and safety evaluation by type of product/endpoint
The consolidated table giving the number of animals used for toxicological and other safety evaluation of products (EU Table 3) in 27 Member States in 2008 is presented in Table 3.1 at the end of this chapter. In table 3.1 the number of animals used for toxicological or other safety evaluation is broken down into types of products for which testing was required.
The percentage of the number of animals used for different types of product is presented in Figure 3.
III.4.2.Treatment and interpretation of the data
The number of animals used for toxicological and other safety evaluation for different products or environmental test schemes amounts to 1,042,153, which represents 8,7% of the total number of animals used for experimental purposes in 2008 (see Table 2.1, column 2.6).
Toxicological or other safety evaluations are split up according to the type of sector for which they are intended. The percentage of animals used for toxicological evaluation of three groups of products/substances, i.e. additives in food for human consumption, cosmetics and household products, is very small (1,18%) when compared to the other product groups.
Products or devices used for human medicine, veterinary medicine and dentistry represents 50,8% of the animals used for toxicological or other safety evaluations.
The group of products/substances falling under the scrutiny of Member States authorities concerned with safety of health and of the environment by chemical products, such as industrial chemicals and pesticides, used 15% of the animals for toxicological and other safety evaluations.
There is a clear decrease in the number of animals used for toxicological tests for products intended for industry, for agriculture and for potential contaminants of the environment. The decrease ranges respectively from above 96,000 to about 82,000; from below 98,000 to about 74,000 and from above 84,000 to about 65,000 in comparison to the data submitted in the 2005 statistical report.
There is also a significant decrease in the number of animals used for testing of products for cosmetics and toiletries ranging from 5,500 to just below 2,000 (a 65% drop). This change has to be seen in light of the legal requirement to phase out animal testing for cosmetics in the EU where a ban on testing has been applicable since 2009 for all human health effects with the exception of three toxicological end-points: repeated-dose toxicity, reproductive toxicity and toxicokinetics. The year 2013 is the deadline for a marketing ban for cosmetics tested for these remaining specific health effects.
There is however also a significant increase since 2005 in the number of animals used for tests for additives in food for animal consumption (from 34,225 to 54,164). This may reflect the animal feed sanitary concerns expressed in the EU after the discovery of harmful contaminants in such products over the last 10 years.
It should also be noted that in comparison to the 2005 report, there is a significant increase in the number of animals used for ‘other’ toxicological or safety evaluation (ranging from around 180,000 to about 220,000). Member States reported that this particular use of animals concerned new methods and tests, such as tests on transmission of microcystins on embryonic membrane, bioassays, toxicity evaluation for humans via the environment, and control of safety of toys.
Table 3.1: Number of animals used in toxicological and other safety evaluation
Products versus species
Data of 2008*
|
3.1.Species |
3.2. Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3. Products/ substances used or intended to be used mainly in agriculture |
3.4.Products/ substances used or intended to be used mainly in industry |
3.5.Products/ substances used or intended to be used mainly in the household |
3.6.Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7.Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8.Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9.Potential or actual contaminants in the general environment which do not appear in other columns |
3.10.Other toxicological or safety evaluations |
3.11.Total |
|
1.a. Mice (Mus musculus) |
188227 |
10129 |
20249 |
1922 |
880 |
2818 |
1680 |
9433 |
162919 |
398257 |
|
1.b. Rats (Rattus norvegicus) |
187283 |
31421 |
41562 |
1709 |
174 |
2764 |
303 |
2932 |
26496 |
294644 |
|
1.c. Guinea-Pigs (Cavia porcellus) |
23152 |
2830 |
3679 |
0 |
38 |
24 |
7 |
0 |
2192 |
31922 |
|
1.d. Hamsters (Mesocricetus ) |
1559 |
0 |
21 |
0 |
0 |
0 |
0 |
0 |
0 |
1580 |
|
1.e. Other Rodents (other Rodentia) |
0 |
164 |
0 |
0 |
0 |
0 |
0 |
204 |
27 |
395 |
|
1.f. Rabbits (Oryctolagus cuniculus) |
30516 |
2696 |
4453 |
50 |
153 |
11 |
7 |
12 |
2127 |
40025 |
|
1.g. Cats (Felis catus) |
312 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
322 |
|
1.h. Dogs (Canis familiaris) |
9888 |
340 |
16 |
0 |
0 |
0 |
0 |
0 |
833 |
11077 |
|
1.i. Ferrets (Mustela putorius furo) |
269 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
269 |
|
1.j. Other Carnivores (other Carnivore) |
296 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
296 |
|
1.k. Horses, donkeys and cross breds (Equidae) |
22 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
|
1.l. Pigs (Sus) |
3169 |
90 |
0 |
0 |
0 |
100 |
4584 |
64 |
66 |
8073 |
|
1.m. Goats (Capra) |
21 |
14 |
0 |
0 |
0 |
0 |
0 |
8 |
0 |
43 |
|
1.n. Sheep (Ovis) |
408 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
409 |
|
1.o. Cattle (Bos) |
409 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
44 |
457 |
|
1.p. Prosimians (Prosimia) |
543 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
543 |
|
1.q. New World Monkeys (Ceboidea) |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
70 |
270 |
|
1.r. Old World Monkeys (Cercopithecoidea) |
5121 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
573 |
5694 |
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. Other Mammals (other Mammalia) |
0 |
210 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
210 |
|
1.u. Quail (Coturnix coturnix) |
64 |
2110 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2174 |
|
1.v. Other birds (other Aves) |
8838 |
2116 |
30 |
0 |
0 |
0 |
39553 |
97 |
320 |
50954 |
|
1.w. Reptiles (Reptilia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.x. Amphibians (Amphibia) |
179 |
108 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
291 |
|
1.y. Fish (Pisces) |
69021 |
21915 |
12416 |
601 |
722 |
523 |
8030 |
53062 |
27936 |
194226 |
|
1.z. TOTAL |
529497 |
74147 |
82426 |
4282 |
1967 |
6240 |
54164 |
65812 |
223618 |
1042153 |
(*) France reporting for 2007
III.5.Results of EU Table 4: Animals used for studies of diseases
III.5.1.The data on animals used for studies of diseases
The consolidated table of results on animals used for studies of diseases (EU Table 4) in the 27 Member States is presented in Table 4.1 at the end of this chapter.
III.5.2.Treatment and interpretation of the data
Table 4.1 gives the number of animals used per type of studies on diseases.
In 2008 the number of animals used for the study of both animal and human diseases represented about 6,322,000 animals which is more than half (52%) the total number of animals used for experimental purposes in the EU.
Figure 4.1 presents the percentage of animals used in studies per type of diseases.
The proportion of animals used for studies of human diseases represents more than 90% of the total number of animals used for all disease studies.
Overall in 2008 there is a 50% decrease in the number of animals used for studies on specific animal diseases - from 1,329,000 to 614,000. In particular, a significant change occurred in the use of cold-blooded species where figures decreased from around 954,000 animals in 2005 to 43,914 in 2008.
Interesting to note is that despite the overall decrease, the use of mice increased substantially in 2008. Around 35% of the increase (about 681,000) can be attributed to different studies of diseases (see also observations under chapter III.3.3).
Some Member States confirmed that the increase of the use of animals in general, or mice in particular in table 4, is also reported under several headings of table 2, such as fundamental biological research and research and development of products for human and veterinary medicine and even production and control process for human and veterinary medicine. For the 2008 data one Member States indicated, however, that the increase of use of mice was primarily attributed to fundamental biological research.
It should be remembered that the studies on specific animal diseases are important in light of epidemic diseases affecting animals such as in the case of foot and mouth disease, swine fever and more recently avian flew. However, animals have also been used in studies on genetic diseases. According to 2008 data there has been more than a 50% reduction in animals used for studies on animal diseases. This could be because there have been no new significant animal disease epidemics in 2008 or in the preceding years.
The above observation is not necessarily reflected in the use of all species in particular for the use of mice and other birds by some Member States.
Regarding the specific animal diseases studies linked to the increase in the number of birds, Member States reported studies on bird flu, Gumboro disease and bronchitis including studies on quality and safety of vaccines.
Table 4.1: Number of animals used in experiments for studies on human and animal diseases
Main category of diseases versus species
Data of 2008 *
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
1.a. Mice (Mus musculus) |
249486 |
858612 |
803038 |
1883499 |
292772 |
4087407 |
|
1.b. Rats (Rattus norvegicus) |
125904 |
489630 |
43336 |
600979 |
16909 |
1276758 |
|
1.c. Guinea-Pigs (Cavia porcellus) |
2856 |
5004 |
262 |
47326 |
3252 |
58700 |
|
1.d. Hamsters (Mesocricetus ) |
1940 |
2986 |
791 |
6751 |
3104 |
15572 |
|
1.e. Other Rodents (other Rodentia) |
673 |
6737 |
239 |
5093 |
4617 |
17359 |
|
1.f. Rabbits (Oryctolagus cuniculus) |
5373 |
1386 |
1781 |
28138 |
6983 |
43661 |
|
1.g. Cats (Felis catus) |
14 |
169 |
0 |
126 |
1930 |
2239 |
|
1.h. Dogs (Canis familiaris) |
1233 |
207 |
144 |
4544 |
3810 |
9938 |
|
1.i. Ferrets (Mustela putorius furo) |
20 |
184 |
0 |
2153 |
105 |
2462 |
|
1.j. Other Carnivores (other Carnivore) |
72 |
0 |
0 |
468 |
411 |
951 |
|
1.k. Horses, donkeys and cross breds (Equidae) |
3 |
0 |
0 |
154 |
1614 |
1771 |
|
1.l. Pigs (Sus) |
4638 |
417 |
100 |
9589 |
17299 |
32043 |
|
1.m. Goats (Capra) |
170 |
39 |
87 |
478 |
1014 |
1788 |
|
1.n. Sheep (Ovis) |
597 |
601 |
24 |
8065 |
6833 |
16120 |
|
1.o. Cattle (Bos) |
243 |
36 |
0 |
2860 |
13756 |
16895 |
|
1.p. Prosimians (Prosimia) |
0 |
40 |
0 |
311 |
370 |
721 |
|
1.q. New World Monkeys (Ceboidea) |
7 |
101 |
0 |
419 |
21 |
548 |
|
1.r. Old World Monkeys (Cercopithecoidea) |
111 |
261 |
6 |
3173 |
8 |
3559 |
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. Other Mammals (other Mammalia) |
29 |
55 |
5 |
887 |
449 |
1425 |
|
1.u. Quail (Coturnix coturnix) |
0 |
400 |
0 |
177 |
413 |
990 |
|
1.v. Other birds (other Aves) |
4769 |
4563 |
47 |
21365 |
194727 |
225471 |
|
1.w. Reptiles (Reptilia) |
0 |
90 |
0 |
0 |
934 |
1024 |
|
1.x. Amphibians (Amphibia) |
362 |
603 |
2886 |
10852 |
2022 |
16725 |
|
1.y. Fish (Pisces) |
5841 |
57964 |
2458 |
381109 |
40958 |
488330 |
|
1.z. TOTAL |
404341 |
1430085 |
855204 |
3018516 |
614311 |
6322457 |
France reporting for 2007
Table 4.2: Number of animals used in studies of diseases by classes of animals
|
Classes of animals |
Human Cardiovascular diseases |
Human nervous and mental disorder |
Human cancer (excl. evaluation of carcino. hazards) |
Other human diseases |
Specific animal diseases |
Total |
|
Mice |
249486 |
858612 |
803038 |
1883499 |
292772 |
4087407 |
|
Rats |
125904 |
489630 |
43336 |
600979 |
16909 |
1276758 |
|
Guinea-Pigs |
2856 |
5004 |
262 |
47326 |
3252 |
58700 |
|
Other rodents |
2613 |
9723 |
1030 |
11844 |
7721 |
32931 |
|
Rabbits |
5373 |
1386 |
1781 |
28138 |
6983 |
43661 |
|
Carnivores |
1339 |
560 |
144 |
7291 |
6256 |
15590 |
|
Artio + Perrisodactyla |
5651 |
1093 |
211 |
21146 |
40516 |
68617 |
|
Prosimians+Monkeys+Apes |
118 |
402 |
6 |
3903 |
399 |
4828 |
|
Other Mammals |
29 |
55 |
5 |
887 |
449 |
1425 |
|
Birds |
4769 |
4963 |
47 |
21542 |
195140 |
226461 |
|
Cold-blooded animals |
6203 |
58657 |
5344 |
391961 |
43914 |
506079 |
|
TOTAL |
404341 |
1430085 |
855204 |
3018516 |
614311 |
6322457 |
|
Classes of animals% |
Human Cardiovascular diseases |
Human nervous and mental disorder |
Human cancer (excl. evaluation of carcino. hazards) |
Other human diseases |
Specific animal diseases |
Total |
|
Mice |
6,10 |
21,01 |
19,65 |
46,08 |
7,16 |
100,00 |
|
Rats |
9,86 |
38,35 |
3,39 |
47,07 |
1,32 |
100,00 |
|
Guinea-Pigs |
4,87 |
8,52 |
0,45 |
80,62 |
5,54 |
100,00 |
|
Other rodents |
7,93 |
29,53 |
3,13 |
35,97 |
23,45 |
100,00 |
|
Rabbits |
12,31 |
3,17 |
4,08 |
64,45 |
15,99 |
100,00 |
|
Carnivores |
8,59 |
3,59 |
0,92 |
46,77 |
40,13 |
100,00 |
|
Artio + Perrisodactyla |
8,24 |
1,59 |
0,31 |
30,82 |
59,05 |
100,00 |
|
Prosimians+Monkeys+Apes |
2,44 |
8,33 |
0,12 |
80,84 |
8,26 |
100,00 |
|
Other Mammals |
2,04 |
3,86 |
0,35 |
62,25 |
31,51 |
100,00 |
|
Birds |
2,11 |
2,19 |
0,02 |
9,51 |
86,17 |
100,00 |
|
Cold-blooded animals |
1,23 |
11,59 |
1,06 |
77,45 |
8,68 |
100,00 |
Species of Table 4.1 were grouped into classes of animals and presented in Table 4.2. The relative percentage of animals per class of species used in studies by type of disease has been calculated and is also presented in the lower part of Table 4.2.
Figure 4.2 presents the proportion of animals used by classes per type of studies of diseases.
The top of each bar shows the relative percentage of animals used for studies on specific animal diseases. Significant numbers of both artiodactyla and perissodactyla and birds are used for this purpose. Member States reported that it is still current practice to test vaccines on these species. However, in some Member States only birds are used if the infection concerns bird species.
The data on the use of most species for all types of studies on both human and animal diseases show a great similarity to the data of 2005. However, there is a substantial decrease in the use of ‘other mammals’ for studies of human diseases in particular 'other human diseases', whereas the opposite is observed for cold-blooded animals which have been more widely used in studies on human diseases rather than animal diseases.
III.6.Results of EU Table 5: Animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine
III.6.1.The data on animals used in production and quality control of products for human medicine and dentistry and for veterinary medicine
The consolidated table for the 27 Member States reporting the origin of the regulatory requirements in relation to animals used for the production and quality control of products for human medicine and dentistry and for veterinary medicine (EU Table 5) is presented in Table 5.1 at the end of this chapter.
III.6.2.Treatment and interpretation of the data
The number of animals used in tests for the production and quality control of products for human medicine and dentistry and for veterinary medicine represents 14,9% of the total number of animals used for experimental purposes. Figure 5 gives the percentages of the animals used to satisfy the different regional regulatory requirements in this area.
The largest proportion of animals in this area (47%) was used to satisfy requirements from several pieces of legislation (from national, the EU, the Council of Europe member country legislation, and from legislation outside of the EU (Fig 5)). The testing carried out to satisfy EU legislation including the European Pharmacopoeia covered 41,1% of the animals used in this area.
In comparison to the report of 2005 there is a net decrease in the number of animals used to satisfy simultaneously several pieces of legislation. On the other hand there is a net increase of tests carried out for the European legislation (including the European Pharmacopoeia).
Consequently, there is a net decrease in the number of animals used to satisfy national legislation, which is an encouraging trend showing an attempt to move towards EU harmonisation of regulatory requirements.
Table 5.1: Number of animals used in the production and quality control of products and devices for human medicine and dentistry and for veterinary medicine
Regulatory requirements versus species
Data of 2008 *
|
5.1. Species |
5.2. National legislation specific to a single EC Member State1 |
5.3. EC legislation including European Pharmacopoeia (requirements) |
5.4. Member Country of Council of Europe (but not EC) legislation2) |
5.5. Other legislation |
5.6. Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7. No regulatory requirements |
5.8. Total |
|
1.a. Mice (Mus musculus) |
33233 |
359722 |
371 |
21567 |
569279 |
43303 |
1027475 |
|
1.b. Rats (Rattus norvegicus) |
5107 |
86403 |
405 |
16406 |
105741 |
5319 |
219381 |
|
1.c. Guinea-Pigs (Cavia porcellus) |
2519 |
43916 |
0 |
6494 |
62550 |
5615 |
121094 |
|
1.d. Hamsters (Mesocricetus ) |
0 |
8916 |
0 |
358 |
3613 |
2 |
12889 |
|
1.e. Other Rodents (other Rodentia) |
0 |
0 |
0 |
0 |
30 |
0 |
30 |
|
1.f. Rabbits (Oryctolagus cuniculus) |
851 |
107271 |
0 |
1077 |
53039 |
20539 |
182777 |
|
1.g. Cats (Felis catus) |
43 |
614 |
0 |
8 |
58 |
10 |
733 |
|
1.h. Dogs (Canis familiaris) |
208 |
985 |
0 |
0 |
982 |
55 |
2230 |
|
1.i. Ferrets (Mustela putorius furo) |
0 |
2 |
0 |
0 |
522 |
48 |
572 |
|
1.j. Other Carnivores (other Carnivore) |
27 |
311 |
0 |
0 |
0 |
0 |
338 |
|
1.k. Horses, donkeys and cross breds (Equidae) |
307 |
225 |
0 |
0 |
164 |
2087 |
2783 |
|
1.l. Pigs (Sus) |
518 |
5436 |
0 |
91 |
2385 |
994 |
9424 |
|
1.m. Goats (Capra) |
68 |
27 |
0 |
3 |
10 |
11 |
119 |
|
1.n. Sheep (Ovis) |
805 |
1523 |
54 |
5 |
703 |
5079 |
8169 |
|
1.o. Cattle (Bos) |
139 |
2500 |
0 |
6 |
414 |
469 |
3528 |
|
1.p. Prosimians (Prosimia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.q. New World Monkeys (Ceboidea) |
0 |
0 |
0 |
0 |
33 |
0 |
33 |
|
1.r. Old World Monkeys (Cercopithecoidea) |
0 |
0 |
0 |
0 |
231 |
0 |
231 |
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. Other Mammals (other Mammalia) |
13 |
50 |
0 |
0 |
0 |
28 |
91 |
|
1.u. Quail (Coturnix coturnix) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.v. Other birds (other Aves) |
1887 |
117540 |
60 |
1676 |
41194 |
7556 |
169913 |
|
1.w. Reptiles (Reptilia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.x. Amphibians (Amphibia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.y. Fish (Pisces) |
2260 |
1430 |
0 |
0 |
406 |
24137 |
28233 |
|
1.z. TOTAL |
47985 |
736871 |
890 |
47691 |
841354 |
115252 |
1790043 |
(*) France reporting for 2007
|
Examples: |
5.2 - France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out |
|||
|
5.3 - UK is testing according to EC legislation |
and not to the body which has issued the actual test method, guideline or protocol |
|||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||
|
5.6 - Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of Macedonia' Turkey, Ukraine |
|||||
III.7.Results of EU harmonized Table 6: Origin of regulatory requirements for animals used in toxicological and other safety evaluations
III.7.1.The data on the origin of regulatory requirements for animals used in toxicological and other safety evaluations
The consolidated table for the 27 Member States reporting data on animals used in toxicological and other safety evaluations in relation to the origin of regulatory requirements (EU Table 6) is presented in Table 6.1 at the end of this chapter.
III.7.2.Treatment and interpretation of the data
The use of animals for the regulatory requirements of different regions in the area of toxicological or other safety evaluation presented in Figure 6 follows a similar pattern to that of the use of animals used for regulatory purposes in human medicine, dentistry and in veterinary medicine in different regions, presented in the Figure 5 in the previous chapter.
As pointed out earlier, the number of animals used in toxicological or other safety evaluation represents 8,7% of the total number of animals used for experimental purposes in the EU.
Animals used to simultaneously satisfy regulatory requirements from several pieces of legislation covered almost half of the animals used in this area (50%). The testing required under EU legislation including the European Pharmacopoeia accounts for the second highest percentage in this area, namely 24%.
The increase of the numbers of animals used for toxicological and other safety evaluations since the last report is relatively low and represents about 15,800 animals.
In comparison to the last report there is a net slight decrease in the proportion of animals used to simultaneously satisfy several pieces of regional legislation from 54% to nearly 50%.
However, there is a substantial increase in the proportion of animals used for no regulatory requirements. In order to explain what is meant by the term 'no regulatory requirements', some Member States gave as an example projects using in-house methods to verify the safety and efficacy of veterinary biologicals and medicinal products using animals, and carried out according to a company’s standards. The results may be accepted by that Member State national authority, although not required by legislation.
The testing carried out in 2008 to satisfy national legislation specific to a single Member State showed a decrease of about 7,500 animals which represents roughly a 1,2% decrease compared to the last report.
Table 6.1: Number of animals used in toxicological and other safety evaluations
Regulatory requirements versus species
Data of 2008*
|
6.1. Species |
6.2. National legislation specific to a single EC Member State1) |
6.3. EC legislation including European Pharmacopoeia (requirements) |
6.4. Member Country of Council of Europe (but not EC) legislation2) |
6.5. Other legislation |
6.6. Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
6.7. No regulatory requirements |
6.8.Total |
|
1.a. Mice (Mus musculus) |
35721 |
129353 |
752 |
5034 |
198942 |
28397 |
398199 |
|
1.b. Rats (Rattus norvegicus) |
17191 |
51343 |
89 |
11496 |
194371 |
20093 |
294583 |
|
1.c. Guinea-Pigs (Cavia porcellus) |
660 |
14723 |
84 |
390 |
15166 |
960 |
31983 |
|
1.d. Hamsters (Mesocricetus ) |
101 |
238 |
0 |
0 |
1106 |
135 |
1580 |
|
1.e. Other Rodents (other Rodentia) |
204 |
0 |
0 |
0 |
191 |
0 |
395 |
|
1.f. Rabbits (Oryctolagus cuniculus) |
1179 |
12694 |
2 |
1744 |
23426 |
942 |
39987 |
|
1.g. Cats (Felis catus) |
97 |
126 |
4 |
0 |
85 |
10 |
322 |
|
1.h. Dogs (Canis familiaris) |
626 |
1421 |
58 |
769 |
8023 |
180 |
11077 |
|
1.i. Ferrets (Mustela putorius furo) |
211 |
32 |
0 |
26 |
0 |
0 |
269 |
|
1.j. Other Carnivores (other Carnivore) |
296 |
0 |
0 |
0 |
0 |
0 |
296 |
|
1.k. Horses, donkeys and cross breds (Equidae) |
0 |
0 |
0 |
0 |
1 |
21 |
22 |
|
1.l. Pigs (Sus) |
172 |
1177 |
8 |
181 |
6102 |
425 |
8065 |
|
1.m. Goats (Capra) |
29 |
0 |
0 |
0 |
14 |
0 |
43 |
|
1.n. Sheep (Ovis) |
2 |
75 |
0 |
0 |
322 |
10 |
409 |
|
1.o. Cattle (Bos) |
10 |
226 |
0 |
44 |
173 |
0 |
453 |
|
1.p. Prosimians (Prosimia) |
0 |
543 |
0 |
0 |
0 |
0 |
543 |
|
1.q. New World Monkeys (Ceboidea) |
0 |
0 |
0 |
0 |
246 |
24 |
270 |
|
1.r. Old World Monkeys (Cercopithecoidea) |
0 |
265 |
0 |
732 |
4599 |
98 |
5694 |
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. Other Mammals (other Mammalia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.u. Quail (Coturnix coturnix) |
24 |
680 |
0 |
0 |
1466 |
0 |
2170 |
|
1.v. Other birds (other Aves) |
10 |
7406 |
0 |
5000 |
36017 |
2798 |
51231 |
|
1.w. Reptiles (Reptilia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.x. Amphibians (Amphibia) |
0 |
0 |
0 |
0 |
179 |
112 |
291 |
|
1.y. Fish (Pisces) |
32582 |
29413 |
0 |
1517 |
27071 |
103688 |
194271 |
|
1.z. TOTAL |
89115 |
249715 |
997 |
26933 |
517500 |
157893 |
1042153 |
(*)France is reporting for 2007
|
Examples: |
6.2 - France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and not to the body which has issued the actual test method, guideline or protocol |
|||
|
6.3 - UK is testing according to EC legislation |
||||||
|
6.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||
|
6.6 - Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of Macedonia' Turkey, Ukraine |
|||||
III.8.Results of EU Table 7: Animals used in toxicity tests for toxicological and other safety evaluations
III.8.1.The data on animals used in toxicity test for toxicological and other safety evaluations
The consolidated table for the 27 Member States reporting on animals used in toxicity tests for the purpose of toxicological and other safety evaluations of products (EU Table 7) is presented in Table 7.1 at the end of this chapter.
III.8.2.Treatment and interpretation of the data
For the convenience of the presentation of results some of the toxicity tests of Table 7.1 have been grouped according to systemic and local toxicity and CMR (carcinogenicity, mutagenicity and toxicity to reproduction) effects in Table 7.2. A graph showing the percentage of animals used per toxicity test groups in 2008 is presented in Figure 7.
As pointed out in the previous chapter, the number of animals used in toxicological and other safety evaluations represents 8,7% of the total number of animals used for experimental purposes.
In Figure 7 the largest percentage (almost 45%) of use of animals in toxicological and other safety evaluations is due to acute and sub-acute toxicity tests. Also taking into account sub-chronic and chronic toxicity, the percentage of animals used in short and long term systemic toxicity testing accounts for 55% in this area.
13,7% of animals were used for testing carcinogenicity, mutagenicity and toxicity to reproduction. Another important category of use of animals in 2008 is for 'other tests' with 24%. Breaking down further the category 'other', Member States reported testing in areas such as biological screening for pharmaceutical, healthcare and veterinary products. This includes neurotoxicity, toxicokinetics, testing of biological evaluation of medical devices: Intracutaneous testing of reactivity in rabbits, studies into the penetration of nanoparticles through tissue and their biocompatibility, studies into the evaluation of sensitization potential of dyestuffs used in the textile industry and pharmacological studies included in safety tests.
By looking both in numbers and relative percentages of use of animals in comparison to the previous reports there are two noticeable changes:
There is a continuous increase over the last three reports of the proportion of animals used for acute and sub-acute tests, ranging from 36% - 42% to almost 45% respectively. This represents in animal numbers an increase of more than 37,000 animals since the last report. Member States attributed the increase in part to several phases in new product development and new legislation, for example requiring that all generic substances should be tested.
On the other hand one can observe a steady decrease over the last three reports of the animals used for reproductive toxicity testing from: 12% to 10% and to 9% respectively. This demonstrates a saving since the 2005 report of 8,650 animals.
A general decrease in the number of animals used for regulatory toxicological evaluation could be attributed to the use of alternative methods according to some Member States. However, others have suggested that replacement methods have a much greater impact on research and development than on regulatory requirements.
Table 7.1: Number of animals used in toxicological and other safety evaluations
Type of tests versus species
Data of 2008*
|
7.1. Species |
7.2. Acute and sub-acute toxicity testing methods (including limit test) |
7.3. Skin irritation |
7.4. Skin sensitisation |
7.5. Eye irritation |
7.6. Sub- chronic and chronic toxicity |
7.7. Carcino- genicity |
7.8. Develop- mental toxicity |
7.9. Muta- genicity |
7.10. Repro-ductive toxicity |
7.11. Toxicity to aquatic vertebra-tes not included in other columns |
7.12. Other |
7.13. Total |
||
|
|
7.2.1. LD50, LC50 |
7.2.2. Other lethal methods |
7.2.3. Non lethal clinical signs methods |
|
|
|
|
|
|
|
|
|
|
|
|
1.a. Mice (Mus musculus) |
87440 |
87455 |
46654 |
926 |
16742 |
30 |
27173 |
10375 |
3744 |
12858 |
2759 |
200 |
101843 |
398199 |
|
1.b. Rats (Rattus norvegicus) |
7060 |
12651 |
74924 |
768 |
1465 |
78 |
54915 |
10219 |
20263 |
14043 |
51314 |
26 |
46957 |
294683 |
|
1.c. Guinea-Pigs (Cavia porcellus) |
1000 |
303 |
3363 |
140 |
20198 |
6 |
618 |
0 |
120 |
0 |
101 |
7 |
6027 |
31883 |
|
1.d. Hamsters (Mesocricetus ) |
16 |
0 |
343 |
22 |
0 |
0 |
310 |
0 |
0 |
21 |
0 |
0 |
868 |
1580 |
|
1.e. Other Rodents (other Rodentia) |
27 |
0 |
0 |
0 |
0 |
0 |
204 |
0 |
0 |
0 |
0 |
0 |
164 |
395 |
|
1.f. Rabbits (Oryctolagus cuniculus) |
110 |
38 |
5875 |
4200 |
32 |
2105 |
1240 |
0 |
6047 |
0 |
5349 |
7 |
14984 |
39987 |
|
1.g. Cats (Felis catus) |
0 |
0 |
24 |
0 |
0 |
0 |
62 |
0 |
0 |
0 |
0 |
0 |
236 |
322 |
|
1.h. Dogs (Canis familiaris) |
15 |
339 |
4637 |
0 |
0 |
0 |
4582 |
0 |
0 |
0 |
20 |
0 |
1484 |
11077 |
|
1.i. Ferrets (Mustela putorius furo) |
0 |
0 |
211 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
58 |
269 |
|
1.j. Other Carnivores (other Carnivore) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
296 |
296 |
|
1.k. Horses, donkeys and cross breds (Equidae) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
22 |
|
1.l. Pigs (Sus) |
0 |
11 |
535 |
115 |
0 |
0 |
937 |
0 |
0 |
0 |
112 |
0 |
6355 |
8065 |
|
1.m. Goats (Capra) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
43 |
43 |
|
1.n. Sheep (Ovis) |
0 |
0 |
36 |
0 |
0 |
0 |
34 |
0 |
0 |
0 |
0 |
0 |
339 |
409 |
|
1.o. Cattle (Bos) |
0 |
0 |
60 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
22 |
0 |
359 |
453 |
|
1.p. Prosimians (Prosimia) |
0 |
0 |
261 |
0 |
0 |
0 |
143 |
0 |
0 |
0 |
0 |
0 |
139 |
543 |
|
1.q. New World Monkeys (Ceboidea) |
0 |
0 |
65 |
0 |
0 |
0 |
71 |
0 |
64 |
0 |
0 |
0 |
70 |
270 |
|
1.r. Old World Monkeys (Cercopithecoidea) |
18 |
0 |
1735 |
0 |
0 |
0 |
2861 |
0 |
176 |
0 |
58 |
0 |
846 |
5694 |
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. Other Mammals (other Mammalia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.u. Quail (Coturnix coturnix) |
819 |
241 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
176 |
0 |
934 |
2170 |
|
1.v. Other birds (other Aves) |
456 |
135 |
5937 |
1020 |
0 |
65 |
0 |
0 |
0 |
0 |
108 |
0 |
43510 |
51231 |
|
1.w. Reptiles (Reptilia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.x. Amphibians (Amphibia) |
0 |
0 |
0 |
0 |
0 |
0 |
108 |
0 |
4 |
0 |
0 |
0 |
179 |
291 |
|
1.y. Fish (Pisces) |
50983 |
70000 |
5110 |
119 |
0 |
0 |
9735 |
213 |
868 |
0 |
3796 |
24857 |
28590 |
194271 |
|
1.z. TOTAL |
147944 |
171173 |
149770 |
7310 |
38437 |
2284 |
103005 |
20807 |
31286 |
26922 |
63815 |
25097 |
254303 |
1042153 |
(*) France reporting for 2007
Table 7.2: Grouping of certain type of tests on animals of table 7.1
|
7.1. Species |
Acute and sub-acute toxicity testing methods (including limit test) |
Irritation /sensitization tests |
Sub- chronic and chronic toxicity |
Mutagenicity and carcinogenicity |
Reproductive and developmental toxicity |
Toxicity to aquatic vertebrates not included in other columns |
other |
Total |
|
1.a. Mice (Mus musculus) |
221549 |
17698 |
27173 |
23233 |
6503 |
200 |
101843 |
398199 |
|
1.b. Rats (Rattus norvegicus) |
94635 |
2311 |
54915 |
24262 |
71577 |
26 |
46957 |
294683 |
|
1.c. Guinea-Pigs (Cavia porcellus) |
4666 |
20344 |
618 |
0 |
221 |
7 |
6027 |
31883 |
|
1.d. Hamsters (Mesocricetus ) |
359 |
22 |
310 |
21 |
0 |
0 |
868 |
1580 |
|
1.e. Other Rodents (other Rodentia) |
27 |
0 |
204 |
0 |
0 |
0 |
164 |
395 |
|
1.f. Rabbits (Oryctolagus cuniculus) |
6023 |
6337 |
1240 |
0 |
11396 |
7 |
14984 |
39987 |
|
1.g. Cats (Felis catus) |
24 |
0 |
62 |
0 |
0 |
0 |
236 |
322 |
|
1.h. Dogs (Canis familiaris) |
4991 |
0 |
4582 |
0 |
20 |
0 |
1484 |
11077 |
|
1.i. Ferrets (Mustela putorius furo) |
211 |
0 |
0 |
0 |
0 |
0 |
58 |
269 |
|
1.j. Other Carnivores (other Carnivore) |
0 |
0 |
0 |
0 |
0 |
0 |
296 |
296 |
|
1.k. Horses, donkeys and cross breds (Equidae) |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
22 |
|
1.l. Pigs (Sus) |
546 |
115 |
937 |
0 |
112 |
0 |
6355 |
8065 |
|
1.m. Goats (Capra) |
0 |
0 |
0 |
0 |
0 |
0 |
43 |
43 |
|
1.n. Sheep (Ovis) |
36 |
0 |
34 |
0 |
0 |
0 |
339 |
409 |
|
1.o. Cattle (Bos) |
60 |
0 |
12 |
0 |
22 |
0 |
359 |
453 |
|
1.p. Prosimians (Prosimia) |
261 |
0 |
143 |
0 |
0 |
0 |
139 |
543 |
|
1.q. New World Monkeys (Ceboidea) |
65 |
0 |
71 |
0 |
64 |
0 |
70 |
270 |
|
1.r. Old World Monkeys (Cercopithecoidea) |
1753 |
0 |
2861 |
0 |
234 |
0 |
846 |
5694 |
|
1.s. Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. Other Mammals (other Mammalia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.u. Quail (Coturnix coturnix) |
1060 |
0 |
0 |
0 |
176 |
0 |
934 |
2170 |
|
1.v. Other birds (other Aves) |
6528 |
1085 |
0 |
0 |
108 |
0 |
43510 |
51231 |
|
1.w. Reptiles (Reptilia) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.x. Amphibians (Amphibia) |
0 |
0 |
108 |
0 |
4 |
0 |
179 |
291 |
|
1.y. Fish (Pisces) |
126093 |
119 |
9735 |
213 |
4664 |
24857 |
28590 |
194271 |
|
1.z. TOTAL |
468887 |
48031 |
103005 |
47729 |
95101 |
25097 |
254303 |
1042153 |
III.9.Results of EU Table 8: Type of toxicity tests carried out for toxicological and other safety evaluations of products
III.9.1.The data on type of toxicity tests carried out for toxicological and other safety evaluations of products
The consolidated table for the type of toxicity tests carried out for toxicological or other safety evaluations of products for the 27 Member States reporting (EU table 8) is presented in table 8.1 of this report. The data in table 8 have been subjected to a further quality criteria check developed by the Commission. The data provided by all Member States for this report were coherent.
III.9.2.Treatment and interpretation of the data
As pointed out earlier, animals used in toxicological and other safety evaluation represent 8,7% of the total number of animals used for experimental purposes.
In order to facilitate the interpretation of the results some types of toxicity testing have been grouped and the results can be found in consolidated table 8.2 at the end of this chapter. Figure 8 gives the proportion of animals used for toxicity and other safety evaluation by types of products.
The treatment and interpretation of the data on animals used for toxicity tests with regard to the type of products was done for the first time in the Fifth Statistical Report. However, because the graph in that report represented more the relative importance of tests within a type of product rather than the proportion of animals used per type of test for the different products, the graph was modified accordingly for this report.
Figure 8 shows that the majority of animals tested in acute/sub-acute toxicity are intended for the purpose of human medicine, dentistry and veterinary medicine. This is followed by tests carried out for other toxicological or safety evaluation and then for agriculture and industrial products.
Products intended for medicine, dentistry and veterinary medicine require the highest proportion of animals for the different types of tests i.e. approximately 50%. The next highest proportion is for ‘other’ toxicological evaluations, above 20%, followed by animals used in tests for products for agriculture and industry each above 7%.
Table 8.1: Number of animals used in toxicological and other safety evaluations
Type of tests versus products
Data of 2008*
|
8.1. Products |
8.2. Acute and sub-acute toxicity testing methods (including limit test) |
8.3. Skin irritation |
8.4. Skin sensitisation |
8.5. Eye irritation |
8.6. Sub- chronic and chronic toxicity |
8.7. Carcino- genicity |
8.8. Develop- mental toxicity |
8.9. Muta- genicity |
8.10. Repro-ductive toxicity |
8.11. Toxicity to aquatic vertebra-tes not included in other columns |
8.12. Other |
8.13. Total |
||
|
|
8.2.1. LD50, LC50 |
8.2.2. Other lethal methods |
8.2.3. Non lethal clinical signs methods |
|
|
|
|
|
|
|
|
|
|
|
|
8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
43643 |
85795 |
116481 |
3732 |
17719 |
506 |
62442 |
15063 |
12314 |
14286 |
37079 |
3917 |
116640 |
529617 |
|
8.b. Products/ substances used or intended to be used mainly in agriculture |
9066 |
4192 |
4987 |
724 |
4252 |
581 |
10089 |
3590 |
3120 |
2224 |
11578 |
11884 |
7860 |
74147 |
|
8.c. Products/ substances used or intended to be used mainly in industry |
5263 |
4832 |
12483 |
2368 |
11129 |
1001 |
8324 |
306 |
11475 |
6490 |
8863 |
2870 |
7022 |
82426 |
|
8.d. Products/ substances used or intended to be used mainly in the household |
617 |
1636 |
50 |
143 |
0 |
27 |
159 |
0 |
0 |
114 |
1016 |
0 |
520 |
4282 |
|
8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries |
822 |
207 |
98 |
87 |
699 |
54 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1967 |
|
8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption |
64 |
112 |
213 |
3 |
0 |
6 |
1421 |
649 |
3157 |
320 |
167 |
0 |
128 |
6240 |
|
8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption |
0 |
9142 |
177 |
0 |
0 |
0 |
100 |
0 |
0 |
0 |
0 |
80 |
44665 |
54164 |
|
8.h. Potential or actual contaminants in the general environment which do not appear in other columns |
37714 |
6243 |
2206 |
119 |
0 |
0 |
6294 |
213 |
85 |
1502 |
4111 |
4713 |
3410 |
66610 |
|
8.i. Other toxicological or safety evaluations |
10080 |
60404 |
7909 |
173 |
1797 |
94 |
8004 |
2625 |
319 |
2937 |
3176 |
1234 |
123948 |
222700 |
|
8.j. TOTAL |
107269 |
172563 |
144604 |
7349 |
35596 |
2269 |
96833 |
22446 |
30470 |
27873 |
65990 |
24698 |
304193 |
1042153 |
(*) France reporting for 2007
Table 8.2: Number of animals used in toxicological and other safety evaluation per types of products
|
8.1. Products |
Acute and sub-acute toxicity testing methods (including limit test) |
Irritation/sensitization tests |
Sub- chronic and chronic toxicity |
carcinogenicity, Mutagenicity and Reprotox. |
Toxicity to aquatic vertebrates not included in other columns |
Other |
Total |
|
8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
245919 |
21957 |
62442 |
78742 |
3917 |
116640 |
529617 |
|
8.b. Products/ substances used or intended to be used mainly in agriculture |
18245 |
5557 |
10089 |
20512 |
11884 |
7860 |
74147 |
|
8.c. Products/ substances used or intended to be used mainly in industry |
22578 |
14498 |
8324 |
27134 |
2870 |
7022 |
82426 |
|
8.d. Products/ substances used or intended to be used mainly in the household |
2303 |
170 |
159 |
1130 |
0 |
520 |
4282 |
|
8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries |
1127 |
840 |
0 |
0 |
0 |
0 |
1967 |
|
8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption |
389 |
9 |
1421 |
4293 |
0 |
128 |
6240 |
|
8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption |
9319 |
0 |
100 |
0 |
80 |
44665 |
54164 |
|
8.h. Potential or actual contaminants in the general environment which do not appear in other columns |
46163 |
119 |
6294 |
5911 |
4713 |
3410 |
66610 |
|
8.i. Other toxicological or safety evaluations |
78393 |
2064 |
8004 |
9057 |
1234 |
123948 |
222700 |
|
8.j. TOTAL |
424436 |
45214 |
96833 |
146779 |
24698 |
304193 |
1042153 |
EN
|
|
EUROPEAN COMMISSION |
Brussels, 30.9.2010
SEC(2010) 1107 final
VOL B - Part I ([II], [III])
COMMISSION STAFF WORKING DOCUMENT
DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COM(2010) 511 final
Important notice
This is a document of the Commission services and cannot be considered binding to this institution in any way.
VOL B - Part I: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES
TABLE OF CONTENTS
BELGIUM 5
BULGARIA 20
CZECH REPUBLIC 30
DENMARK 39
GERMANY 48
ESTONIA 58
IRELAND 67
GREECE 76
SPAIN 86
BELGIUM
Statistical data submitted
The statistical data have been submitted by the “SPF Santé Publique, Sécurité de la Chaine Alimentaire et Environnement” (Federal Public Service of Public Health, Food Chain Safety and Environment).
Comments of the Belgian authorities
1.Laboratories
Every year, all laboratories in Belgium that use animals for experimental purposes must provide statistical information on the number of animals used the previous year.
In 2008, 389 laboratories were approved as regards the use of animals for experimental purposes and they all provided their statistical data. A quarter of these laboratories had not used any animals for experimental purposes in 2008.
2.Number of animals used in experiments
In all 725370 animals were used. Rodents and rabbits accounted for 93%, fish, reptiles and amphibians for 4% and birds for 2% of the total number of animals used.
Dogs, cats and primates accounted respectively for 0,10%, 0,01% and 0,005% of the animals used in 2008 (Figure 1: Breakdown of species used in experiments)
Figure 1: Breakdown of species used in experiments
A comparison of the absolute figures for 2008 with those for 2007 (Table 1: Trend in the number of animals used in experiments) shows an overall decrease of 54,490 animals (-7%).
This decrease concerns mainly rodents (-53,454; -8%) and fish (-12,489; -31%). However, for some species there has been a marked increase. These are rabbits (+7,301; +21%), mainly used in certain therapeutic polyclonal antibody development programmes, and birds (+4,622; +36%) which were used in 2008 for food tests on poultry. The number of monkeys remained stable and limited in 2008 (41 animals) and in 2007 (38 animals). These primates are used for vaccine quality control tests and for studies of human diseases (neurophysiology).
Table 1: Table 1: Trend in the number of animals used in experiments
|
2008 |
2007 |
2006 |
2005 |
2004 |
|
|
Mice |
480.681 |
518.208 |
516.148 |
488.125 |
482.810 |
|
Rats |
108.580 |
116.991 |
104.272 |
106.483 |
119.193 |
|
Guinea pigs |
36.554 |
43.499 |
38.542 |
39.530 |
38.781 |
|
Hamsters |
2.124 |
1.882 |
1.614 |
1.874 |
1.688 |
|
Other rodents |
1.055 |
1.908 |
1.627 |
2.260 |
3.921 |
|
Rabbits |
42.025 |
34.724 |
30.518 |
21.159 |
18.577 |
|
Total rodents and rabbits |
671.019 |
717.212 |
692.721 |
659.431 |
664.970 |
|
Cats |
78 |
46 |
107 |
81 |
184 |
|
Dogs |
788 |
747 |
1.207 |
1.295 |
1.014 |
|
Ferrets |
324 |
336 |
234 |
154 |
102 |
|
Other carnivores |
0 |
0 |
0 |
0 |
0 |
|
Total carnivores |
1.190 |
1.129 |
1.548 |
1.530 |
1.300 |
|
Horses, donkeys and cross-breeds |
62 |
103 |
108 |
108 |
65 |
|
Pigs |
2.969 |
2.657 |
2.022 |
1.876 |
2.272 |
|
Goats |
195 |
122 |
116 |
157 |
125 |
|
Sheep |
356 |
291 |
295 |
445 |
495 |
|
Cattle |
657 |
616 |
758 |
944 |
982 |
|
Total ungulates |
4.239 |
3.789 |
3.299 |
3.530 |
3.939 |
|
Prosimians |
0 |
0 |
0 |
0 |
0 |
|
New world monkeys |
0 |
0 |
0 |
0 |
7 |
|
Old world monkeys |
41 |
38 |
196 |
449 |
579 |
|
Apes |
0 |
0 |
0 |
0 |
0 |
|
Total primates |
41 |
38 |
196 |
449 |
586 |
|
Other mammals |
151 |
124 |
88 |
59 |
44 |
|
Total mammals |
676.640 |
722.292 |
697.852 |
664.999 |
670.839 |
|
Quails |
431 |
18 |
35 |
425 |
350 |
|
Other birds |
17.151 |
12.942 |
16.127 |
13.266 |
10.492 |
|
Total birds |
17.582 |
12.960 |
16.162 |
13.691 |
10.842 |
|
Reptiles |
374 |
256 |
121 |
1.44 |
129 |
|
Amphibians |
2.388 |
3477 |
3.516 |
6.177 |
6.362 |
|
Fish |
28.386 |
40.875 |
39.064 |
33.965 |
20.574 |
|
Total cold-blooded animals |
31.148 |
44.608 |
42.701 |
40.286 |
27.065 |
|
TOTAL ANIMALS |
725.370 |
779.860 |
756.715 |
718.976 |
708.746 |
The headings in the statistical tables have remained unchanged since 1999. Taking 1999 as a reference year, figure 2 (figure 2: Trend in the number of animals used since 1999) shows that the number of animals used in Belgian laboratories has been relatively stable since then. In 2008 the figure was 8% lower than in 1999.
However, the number of animals has been increasing slightly each year since 2000. This trend must be seen in the context of the high level of research in Belgium, as the increase is essentially due to the rise in the number of animals used in basic research (+34,8% between 2000 and 2008).
Figure 2: Trend in the number of animals used since 1999
3.Experiments carried out
In descending order, animals were used mainly to research and develop products and devices used in human and veterinary medicine (32% of the animals used), in basic research studies (30%) and in tests on the production and quality control of such products and devices (30%) (Figure 3: Breakdown of the experimental fields).
As regards production and quality control tests, 99% of the animals were used to comply with statutory requirements.
Figure 3: Breakdown of the experimental fields
The following diagram (Figure 4: Breakdown of experimental fields by the animals most used) shows that of all the species, rodents are the most used. Rodents account for 82% of animals used for basic research, 94% of animals used for research and development tests on products and devices used in human and veterinary medicine and 84% of animals used for tests on the production and quality control of medical products and devices. Fish account for 11% of the animals used in basic research.
Toxicology and safety tests account for 3% of the animals used in experiments in 2008; 85% of the animals used in toxicology tests were used in safety trials required by law (Figure 5: Proportion of quality control and toxicology tests imposed by law).
Rodents account for 91% of all the animals used in toxicology tests. The other species used are mainly rabbits (5%) and dogs (2,8%).
Figure 4: Breakdown of experimental fields by the animals most used
Figure 5: Proportion of quality control and toxicology tests imposed by law
Provenance of animals used in experiments
In 2008, 89,7% of the animals used for experimental purposes came from approved suppliers in Belgium, other countries of the European Union or members of the Council of Europe and 2,9% came from establishments outside these territories. The other species of animal that are not reared solely for the purposes of agricultural experiments come from establishments that meet the current legal requirements for commercial establishments. The number of animals reused in certain experiments was 0,16% of the total number of animals used in 2008.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
480681 |
141865 |
317570 |
2367 |
18879 |
|
|
1.b. |
Rats (Rattus norvegicus) |
108580 |
19139 |
88029 |
116 |
1296 |
|
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
36554 |
4648 |
29865 |
2041 |
0 |
|
|
1.d. |
Hamsters (Mesocricetus ) |
2124 |
724 |
289 |
1074 |
37 |
|
|
1.e. |
Other Rodents (other Rodentia) |
1055 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
42025 |
38836 |
3189 |
0 |
0 |
589 |
|
1.g. |
Cats (Felis catus) |
78 |
31 |
47 |
0 |
0 |
48 |
|
1.h. |
Dogs (Canis familiaris) |
788 |
47 |
289 |
0 |
452 |
483 |
|
1.i. |
Ferrets (Mustela putorius furo) |
324 |
0 |
185 |
0 |
139 |
0 |
|
1.j. |
Other Carnivores (other Carnivora) |
0 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
62 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
2969 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
195 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
356 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
657 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
0 |
0 |
0 |
0 |
5 |
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
41 |
0 |
12 |
0 |
29 |
28 |
|
1.s. |
Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. |
Other Mammals (other Mammalia) |
151 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
431 |
431 |
0 |
0 |
0 |
|
|
1.v. |
Other birds (other Aves) |
17151 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
374 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
2388 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
28386 |
|
|
|
|
|
|
1.z. |
TOTAL |
725370 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
155149 |
155327 |
138227 |
2445 |
8950 |
8282 |
10086 |
2215 |
480681 |
|
2.b. |
Rats |
20692 |
59947 |
11668 |
697 |
12705 |
246 |
2266 |
359 |
108580 |
|
2.c. |
Guinea-Pigs |
388 |
3531 |
29243 |
647 |
153 |
0 |
2583 |
9 |
36554 |
|
2.d. |
Hamsters |
377 |
0 |
2 |
1653 |
30 |
0 |
62 |
0 |
2124 |
|
2.e. |
Other Rodents |
391 |
660 |
0 |
0 |
0 |
0 |
4 |
0 |
1055 |
|
2.f. |
Rabbits |
1441 |
5293 |
3389 |
30388 |
1213 |
4 |
251 |
46 |
42025 |
|
2.g. |
Cats |
27 |
33 |
0 |
18 |
0 |
0 |
0 |
0 |
78 |
|
2.h. |
Dogs |
49 |
38 |
0 |
18 |
682 |
1 |
0 |
0 |
788 |
|
2.i. |
Ferrets |
12 |
312 |
0 |
0 |
0 |
0 |
0 |
0 |
324 |
|
2.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.k. |
Horses, donkeys and cross breds |
25 |
2 |
0 |
0 |
0 |
0 |
35 |
0 |
62 |
|
2.l. |
Pigs |
1309 |
486 |
0 |
1097 |
0 |
2 |
11 |
64 |
2969 |
|
2.m. |
Goats |
53 |
142 |
0 |
0 |
0 |
0 |
0 |
0 |
195 |
|
2.n. |
Sheep |
183 |
161 |
0 |
4 |
0 |
0 |
8 |
0 |
356 |
|
2.o. |
Cattle |
130 |
85 |
0 |
374 |
44 |
0 |
19 |
5 |
657 |
|
2.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.r. |
Old World Monkeys |
11 |
0 |
29 |
0 |
0 |
1 |
0 |
0 |
41 |
|
2.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.t. |
Other Mammals |
95 |
32 |
24 |
0 |
0 |
0 |
0 |
0 |
151 |
|
2.u. |
Quail |
431 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
431 |
|
2.v. |
Other birds |
10729 |
5855 |
0 |
87 |
0 |
0 |
0 |
480 |
17151 |
|
2.w. |
Reptiles |
374 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
374 |
|
2.x. |
Amphibians |
553 |
1500 |
0 |
0 |
108 |
0 |
227 |
0 |
2388 |
|
2.y. |
Fish |
23406 |
265 |
0 |
0 |
66 |
0 |
3116 |
1533 |
28386 |
|
2.z. |
TOTAL |
215825 |
233669 |
182582 |
37428 |
23951 |
8536 |
18668 |
4711 |
725370 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns |
3.10 Other toxico- logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
6754 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2196 |
8950 |
|
3.b. |
Rats |
11310 |
0 |
45 |
0 |
0 |
0 |
0 |
0 |
1350 |
12705 |
|
3.c. |
Guinea-Pigs |
153 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
153 |
|
3.d. |
Hamsters |
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
|
3.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.f. |
Rabbits |
1213 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1213 |
|
3.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.h. |
Dogs |
682 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
682 |
|
3.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.l. |
Pigs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
44 |
44 |
|
3.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.x. |
Amphibians |
0 |
108 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
108 |
|
3.y. |
Fish |
0 |
0 |
66 |
0 |
0 |
0 |
0 |
0 |
0 |
66 |
|
3.z. |
TOTAL |
20142 |
108 |
111 |
0 |
0 |
0 |
0 |
0 |
3590 |
23951 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
6291 |
65749 |
42230 |
136336 |
3178 |
253784 |
|
4.b. |
Rats |
1652 |
37145 |
1426 |
33261 |
106 |
73590 |
|
4.c. |
Guinea-Pigs |
428 |
95 |
0 |
1805 |
67 |
2395 |
|
4.d. |
Hamsters |
15 |
0 |
18 |
322 |
0 |
355 |
|
4.e. |
Other Rodents |
0 |
640 |
0 |
320 |
76 |
1036 |
|
4.f. |
Rabbits |
152 |
9 |
3 |
322 |
181 |
667 |
|
4.g. |
Cats |
0 |
0 |
0 |
31 |
3 |
34 |
|
4.h. |
Dogs |
202 |
0 |
0 |
56 |
0 |
258 |
|
4.i. |
Ferrets |
0 |
0 |
0 |
312 |
12 |
324 |
|
4.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
36 |
36 |
|
4.l. |
Pigs |
271 |
8 |
0 |
245 |
440 |
964 |
|
4.m. |
Goats |
42 |
0 |
0 |
101 |
28 |
171 |
|
4.n. |
Sheep |
145 |
0 |
0 |
0 |
3 |
148 |
|
4.o. |
Cattle |
0 |
0 |
0 |
0 |
66 |
66 |
|
4.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.r. |
Old World Monkeys |
0 |
0 |
0 |
12 |
0 |
12 |
|
4.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.t. |
Other Mammals |
3 |
6 |
5 |
4 |
61 |
79 |
|
4.u. |
Quail |
0 |
400 |
0 |
0 |
0 |
400 |
|
4.v. |
Other birds |
0 |
0 |
0 |
0 |
7881 |
7881 |
|
4.w. |
Reptiles |
0 |
0 |
0 |
0 |
43 |
43 |
|
4.x. |
Amphibians |
20 |
0 |
0 |
0 |
0 |
20 |
|
4.y. |
Fish |
0 |
0 |
0 |
0 |
2111 |
2111 |
|
4.z. |
TOTAL |
9221 |
104052 |
43682 |
173127 |
14292 |
344374 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
0 |
13396 |
0 |
17081 |
109778 |
417 |
140672 |
||||
|
5.b. |
Rats |
0 |
752 |
0 |
2135 |
7635 |
1843 |
12365 |
||||
|
5.c. |
Guinea-Pigs |
0 |
1609 |
0 |
4708 |
23573 |
0 |
29890 |
||||
|
5.d. |
Hamsters |
0 |
579 |
0 |
0 |
1074 |
2 |
1655 |
||||
|
5.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.f. |
Rabbits |
0 |
1960 |
0 |
1049 |
30766 |
2 |
33777 |
||||
|
5.g. |
Cats |
0 |
18 |
0 |
0 |
0 |
0 |
18 |
||||
|
5.h. |
Dogs |
0 |
18 |
0 |
0 |
0 |
0 |
18 |
||||
|
5.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.l. |
Pigs |
0 |
1097 |
0 |
0 |
0 |
0 |
1097 |
||||
|
5.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.n. |
Sheep |
0 |
4 |
0 |
0 |
0 |
0 |
4 |
||||
|
5.o. |
Cattle |
13 |
361 |
0 |
0 |
0 |
0 |
374 |
||||
|
5.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
29 |
0 |
29 |
||||
|
5.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
24 |
24 |
||||
|
5.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.v. |
Other birds |
0 |
87 |
0 |
0 |
0 |
0 |
87 |
||||
|
5.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.y. |
Fish |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.z. |
TOTAL |
13 |
19881 |
0 |
24973 |
172855 |
2288 |
220010 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
626 |
1113 |
0 |
0 |
5268 |
1943 |
8950 |
||||
|
6.b. |
Rats |
61 |
76 |
0 |
1350 |
9775 |
1443 |
12705 |
||||
|
6.c. |
Guinea-Pigs |
0 |
104 |
0 |
0 |
49 |
0 |
153 |
||||
|
6.d. |
Hamsters |
0 |
0 |
0 |
0 |
30 |
0 |
30 |
||||
|
6.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.f. |
Rabbits |
0 |
183 |
0 |
0 |
1030 |
0 |
1213 |
||||
|
6.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.h. |
Dogs |
0 |
0 |
0 |
0 |
682 |
0 |
682 |
||||
|
6.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.l. |
Pigs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.o. |
Cattle |
0 |
0 |
0 |
44 |
0 |
0 |
44 |
||||
|
6.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
108 |
108 |
||||
|
6.y. |
Fish |
0 |
0 |
0 |
66 |
0 |
0 |
66 |
||||
|
6.z. |
TOTAL |
687 |
1476 |
0 |
1460 |
16834 |
3494 |
23951 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino- genicity |
7.8 Develop- mental toxicity |
7.9 Muta- genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
471 |
9 |
2068 |
0 |
0 |
0 |
553 |
821 |
0 |
202 |
1611 |
0 |
3215 |
8950 |
|
7.b. |
Rats |
0 |
301 |
4533 |
0 |
0 |
0 |
1611 |
1428 |
0 |
1236 |
2151 |
0 |
1445 |
12705 |
|
7.c. |
Guinea-Pigs |
0 |
0 |
27 |
0 |
104 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
153 |
|
7.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
30 |
|
7.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.f. |
Rabbits |
0 |
0 |
306 |
156 |
9 |
0 |
0 |
0 |
0 |
0 |
610 |
0 |
132 |
1213 |
|
7.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.h. |
Dogs |
0 |
0 |
409 |
0 |
0 |
0 |
82 |
0 |
0 |
0 |
0 |
0 |
191 |
682 |
|
7.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.l. |
Pigs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
22 |
0 |
10 |
44 |
|
7.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
108 |
0 |
0 |
0 |
0 |
0 |
0 |
108 |
|
7.y. |
Fish |
66 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
66 |
|
7.z. |
TOTAL |
537 |
310 |
7343 |
156 |
113 |
0 |
2366 |
2249 |
0 |
1438 |
4394 |
0 |
5045 |
23951 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
471 |
283 |
7020 |
156 |
113 |
0 |
1786 |
2228 |
0 |
853 |
4372 |
0 |
2860 |
20142 |
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
0 |
0 |
0 |
0 |
0 |
0 |
108 |
0 |
0 |
0 |
0 |
0 |
0 |
108 |
|
8.c. |
Products/substances used or intended to be used mainly in industry |
66 |
27 |
18 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
111 |
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.i. |
Other toxicological or safety evaluations |
0 |
0 |
305 |
0 |
0 |
0 |
472 |
21 |
0 |
585 |
22 |
0 |
2185 |
3590 |
|
8.j. |
TOTAL |
537 |
310 |
7343 |
156 |
113 |
0 |
2366 |
2249 |
0 |
1438 |
4394 |
0 |
5045 |
23951 |
BULGARIA
Statistical data submitted
The statistical data have been submitted by the National Veterinary Service.
Comments of the Bulgaria authorities
The National Veterinary Service (NVS) is the competent authority on animal welfare matters (AW) in Bulgaria. An organizational and implementation principle is that the AW requirements on the matters concerning animals used for experimental purposes must be performed by the 28 regional veterinary services (RVS) within the NVS. The requirements of Directive 86/609/EEC have been transposed into the national legislation, namely in Ordinance № 15 on the minimum requirements for protection and welfare of laboratory animals and the requirements to the establishments using, breeding and/or supplying such animals (in force since 01.05.2006; published in SG No. 17 of 24 February 2006) and in the Law for Veterinary Activities.
In Bulgaria, experiments involving usage of live animals are carried out only where it is not possible to apply any alternative method(s) of the same purpose and result.
The use of experimental animals is permitted only in establishments, that are authorized as being in compliance with the requirements laid down in Article 153 (1) of the Law on Veterinary Activity and which have official permit signed by the NVS Director-General. The NVS Director-General would issue the above mentioned permit on the basis of an ethical assessment and a positive opinion from the Animal Ethics Commission with NVS. The Animal Ethics Commission has been established as a permanently operating consultative body with the NVS Director-General. This Commission includes the following staff:
1. An official veterinary officer representing NVS;
2. A veterinarian representing the Faculties of Veterinary Medicine;
3. A physician of toxicological specialization representing Ministry of Health;
4. A scientist or researcher of biological specialization representing Bulgarian Academy of Sciences;
5. An environmental expert representing Ministry of Environment and Water;
6. A zoologist representing the Biology Faculty at Sofia University;
7. A physician representing the Medical University in Sofia;
8. Two representatives of NGOs operating in the field of AW and protection of animals;
9. A lawyer representing the Ministry of Agriculture and Food;
10. A veterinarian representing the Ministry of Agriculture and Food.
The following experiments have been carried out in 2008 :
-Biological studies of a fundamental nature
-Research and development of products and devices for human medicine and dentistry and for veterinary medicine (R&D)
- Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine (T&S evaluations)
- Studies and Diagnosis of Human and Animal disease (S&D of disease)
- Education and training (E&T)
Species use in percentage in Bulgaria
The total number of animals used for experimental purposes was 32,581 in 2008 (mostly mice and hamsters). There have not been any non-human primates used for experimental purposes.
Experiments not permitted in Bulgaria:
1. for educational purposes, which cause death of animals; in educational establishments animal experiments shall be replaced by other methods for visualizing the subject taught in all cases where the use of animals might be replaced by other methods and if the aim is not to provide the students with specific practical skills.
2. if the result can be achieved with any method not involving the use of live animal(s);
3. if they use stray and/or domestic dogs or cats as experimental animals.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
16265 |
15820 |
445 |
|
||
|
1.b. |
Rats (Rattus norvegicus) |
4513 |
3124 |
1389 |
|
||
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
3845 |
3807 |
38 |
|
||
|
1.d. |
Hamsters (Mesocricetus ) |
182 |
112 |
70 |
|
||
|
1.e. |
Other Rodents (other Rodentia) |
|
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
813 |
807 |
6 |
|||
|
1.g. |
Cats (Felis catus) |
11 |
11 |
||||
|
1.h. |
Dogs (Canis familiaris) |
15 |
13 |
2 |
|||
|
1.i. |
Ferrets (Mustela putorius furo) |
0 |
|||||
|
1.j. |
Other Carnivores (other Carnivora) |
|
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
17 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
137 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
80 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
250 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
126 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|||||
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
|||||
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
0 |
|||||
|
1.s. |
Apes (Hominoidea) |
0 |
|||||
|
1.t. |
Other Mammals (other Mammalia) |
|
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
|
||||
|
1.v. |
Other birds (other Aves) |
1477 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
|
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
4800 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
50 |
|
|
|
|
|
|
1.z. |
TOTAL |
32581 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
6197 |
108 |
7050 |
264 |
1964 |
682 |
16265 |
||
|
2.b. |
Rats |
237 |
684 |
529 |
30 |
1080 |
1953 |
4513 |
||
|
2.c. |
Guinea-Pigs |
4 |
634 |
2057 |
54 |
1000 |
96 |
3845 |
||
|
2.d. |
Hamsters |
178 |
4 |
182 |
||||||
|
2.e. |
Other Rodents |
0 |
||||||||
|
2.f. |
Rabbits |
37 |
24 |
393 |
60 |
62 |
13 |
216 |
8 |
813 |
|
2.g. |
Cats |
5 |
3 |
4 |
2 |
14 |
||||
|
2.h. |
Dogs |
2 |
10 |
12 |
||||||
|
2.i. |
Ferrets |
0 |
||||||||
|
2.j. |
Other Carnivores |
0 |
||||||||
|
2.k. |
Horses, donkeys and cross breds |
17 |
17 |
|||||||
|
2.l. |
Pigs |
24 |
10 |
10 |
93 |
137 |
||||
|
2.m. |
Goats |
20 |
60 |
80 |
||||||
|
2.n. |
Sheep |
16 |
46 |
15 |
173 |
250 |
||||
|
2.o. |
Cattle |
16 |
110 |
126 |
||||||
|
2.p. |
Prosimians |
0 |
||||||||
|
2.q. |
New World Monkeys |
0 |
||||||||
|
2.r. |
Old World Monkeys |
0 |
||||||||
|
2.s. |
Apes |
0 |
||||||||
|
2.t. |
Other Mammals |
0 |
||||||||
|
2.u. |
Quail |
0 |
||||||||
|
2.v. |
Other birds |
239 |
16 |
30 |
920 |
224 |
48 |
1477 |
||
|
2.w. |
Reptiles |
0 |
||||||||
|
2.x. |
Amphibians |
200 |
4600 |
4800 |
||||||
|
2.y. |
Fish |
50 |
50 |
|||||||
|
2.z. |
TOTAL |
7130 |
1596 |
10074 |
1341 |
4110 |
268 |
8054 |
8 |
32581 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns |
3.10 Other toxico- logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
1900 |
64 |
1964 |
|||||||
|
3.b. |
Rats |
1080 |
1080 |
||||||||
|
3.c. |
Guinea-Pigs |
1000 |
1000 |
||||||||
|
3.d. |
Hamsters |
0 |
|||||||||
|
3.e. |
Other Rodents |
0 |
|||||||||
|
3.f. |
Rabbits |
62 |
62 |
||||||||
|
3.g. |
Cats |
4 |
4 |
||||||||
|
3.h. |
Dogs |
0 |
|||||||||
|
3.i. |
Ferrets |
0 |
|||||||||
|
3.j. |
Other Carnivores |
0 |
|||||||||
|
3.k. |
Horses, donkeys and cross breds |
0 |
|||||||||
|
3.l. |
Pigs |
0 |
|||||||||
|
3.m. |
Goats |
0 |
|||||||||
|
3.n. |
Sheep |
0 |
|||||||||
|
3.o. |
Cattle |
0 |
|||||||||
|
3.p. |
Prosimians |
0 |
|||||||||
|
3.q. |
New World Monkeys |
0 |
|||||||||
|
3.r. |
Old World Monkeys |
0 |
|||||||||
|
3.s. |
Apes |
0 |
|||||||||
|
3.t. |
Other Mammals |
0 |
|||||||||
|
3.u. |
Quail |
0 |
|||||||||
|
3.v. |
Other birds |
0 |
|||||||||
|
3.w. |
Reptiles |
0 |
|||||||||
|
3.x. |
Amphibians |
0 |
|||||||||
|
3.y. |
Fish |
0 |
|||||||||
|
3.z. |
TOTAL |
4046 |
0 |
0 |
0 |
0 |
64 |
0 |
0 |
0 |
4110 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
480 |
1800 |
2280 |
|||
|
4.b. |
Rats |
40 |
50 |
85 |
175 |
||
|
4.c. |
Guinea-Pigs |
4 |
4 |
||||
|
4.d. |
Hamsters |
100 |
8 |
108 |
|||
|
4.e. |
Other Rodents |
0 |
|||||
|
4.f. |
Rabbits |
4 |
2 |
13 |
19 |
||
|
4.g. |
Cats |
0 |
|||||
|
4.h. |
Dogs |
0 |
|||||
|
4.i. |
Ferrets |
0 |
|||||
|
4.j. |
Other Carnivores |
0 |
|||||
|
4.k. |
Horses, donkeys and cross breds |
0 |
|||||
|
4.l. |
Pigs |
0 |
|||||
|
4.m. |
Goats |
0 |
|||||
|
4.n. |
Sheep |
15 |
15 |
||||
|
4.o. |
Cattle |
16 |
16 |
||||
|
4.p. |
Prosimians |
0 |
|||||
|
4.q. |
New World Monkeys |
0 |
|||||
|
4.r. |
Old World Monkeys |
0 |
|||||
|
4.s. |
Apes |
0 |
|||||
|
4.t. |
Other Mammals |
0 |
|||||
|
4.u. |
Quail |
0 |
|||||
|
4.v. |
Other birds |
9 |
254 |
263 |
|||
|
4.w. |
Reptiles |
0 |
|||||
|
4.x. |
Amphibians |
0 |
|||||
|
4.y. |
Fish |
0 |
|||||
|
4.z. |
TOTAL |
48 |
0 |
630 |
1904 |
298 |
2880 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
7314 |
7314 |
|||||||||
|
5.b. |
Rats |
30 |
529 |
559 |
||||||||
|
5.c. |
Guinea-Pigs |
2054 |
57 |
2111 |
||||||||
|
5.d. |
Hamsters |
0 |
||||||||||
|
5.e. |
Other Rodents |
0 |
||||||||||
|
5.f. |
Rabbits |
10 |
443 |
453 |
||||||||
|
5.g. |
Cats |
5 |
5 |
|||||||||
|
5.h. |
Dogs |
3 |
3 |
|||||||||
|
5.i. |
Ferrets |
0 |
||||||||||
|
5.j. |
Other Carnivores |
0 |
||||||||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
5.l. |
Pigs |
10 |
10 |
20 |
||||||||
|
5.m. |
Goats |
0 |
||||||||||
|
5.n. |
Sheep |
0 |
||||||||||
|
5.o. |
Cattle |
0 |
||||||||||
|
5.p. |
Prosimians |
0 |
||||||||||
|
5.q. |
New World Monkeys |
0 |
||||||||||
|
5.r. |
Old World Monkeys |
0 |
||||||||||
|
5.s. |
Apes |
0 |
||||||||||
|
5.t. |
Other Mammals |
0 |
||||||||||
|
5.u. |
Quail |
0 |
||||||||||
|
5.v. |
Other birds |
30 |
920 |
950 |
||||||||
|
5.w. |
Reptiles |
0 |
||||||||||
|
5.x. |
Amphibians |
0 |
||||||||||
|
5.y. |
Fish |
0 |
||||||||||
|
5.z. |
TOTAL |
43 |
10776 |
0 |
0 |
0 |
596 |
11415 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
150 |
1700 |
64 |
50 |
1964 |
||||||
|
6.b. |
Rats |
200 |
780 |
980 |
||||||||
|
6.c. |
Guinea-Pigs |
100 |
1000 |
1100 |
||||||||
|
6.d. |
Hamsters |
0 |
||||||||||
|
6.e. |
Other Rodents |
0 |
||||||||||
|
6.f. |
Rabbits |
60 |
2 |
62 |
||||||||
|
6.g. |
Cats |
4 |
4 |
|||||||||
|
6.h. |
Dogs |
0 |
||||||||||
|
6.i. |
Ferrets |
0 |
||||||||||
|
6.j. |
Other Carnivores |
0 |
||||||||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
6.l. |
Pigs |
0 |
||||||||||
|
6.m. |
Goats |
0 |
||||||||||
|
6.n. |
Sheep |
0 |
||||||||||
|
6.o. |
Cattle |
0 |
||||||||||
|
6.p. |
Prosimians |
0 |
||||||||||
|
6.q. |
New World Monkeys |
0 |
||||||||||
|
6.r. |
Old World Monkeys |
0 |
||||||||||
|
6.s. |
Apes |
0 |
||||||||||
|
6.t. |
Other Mammals |
0 |
||||||||||
|
6.u. |
Quail |
0 |
||||||||||
|
6.v. |
Other birds |
0 |
||||||||||
|
6.w. |
Reptiles |
0 |
||||||||||
|
6.x. |
Amphibians |
0 |
||||||||||
|
6.y. |
Fish |
0 |
||||||||||
|
6.z. |
TOTAL |
250 |
2960 |
70 |
0 |
0 |
830 |
4110 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino- genicity |
7.8 Develop- mental toxicity |
7.9 Muta- genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
1864 |
100 |
1964 |
|||||||||||
|
7.b. |
Rats |
900 |
130 |
50 |
1080 |
||||||||||
|
7.c. |
Guinea-Pigs |
1000 |
1000 |
||||||||||||
|
7.d. |
Hamsters |
0 |
|||||||||||||
|
7.e. |
Other Rodents |
0 |
|||||||||||||
|
7.f. |
Rabbits |
60 |
2 |
62 |
|||||||||||
|
7.g. |
Cats |
4 |
4 |
||||||||||||
|
7.h. |
Dogs |
0 |
|||||||||||||
|
7.i. |
Ferrets |
0 |
|||||||||||||
|
7.j. |
Other Carnivores |
0 |
|||||||||||||
|
7.k. |
Horses, donkeys and cross breds |
0 |
|||||||||||||
|
7.l. |
Pigs |
0 |
|||||||||||||
|
7.m. |
Goats |
0 |
|||||||||||||
|
7.n. |
Sheep |
0 |
|||||||||||||
|
7.o. |
Cattle |
0 |
|||||||||||||
|
7.p. |
Prosimians |
0 |
|||||||||||||
|
7.q. |
New World Monkeys |
0 |
|||||||||||||
|
7.r. |
Old World Monkeys |
0 |
|||||||||||||
|
7.s. |
Apes |
0 |
|||||||||||||
|
7.t. |
Other Mammals |
0 |
|||||||||||||
|
7.u. |
Quail |
0 |
|||||||||||||
|
7.v. |
Other birds |
0 |
|||||||||||||
|
7.w. |
Reptiles |
0 |
|||||||||||||
|
7.x. |
Amphibians |
0 |
|||||||||||||
|
7.y. |
Fish |
0 |
|||||||||||||
|
7.z. |
TOTAL |
3824 |
130 |
150 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
4110 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
3760 |
130 |
150 |
2 |
4 |
4046 |
||||||||
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
0 |
|||||||||||||
|
8.c. |
Products/substances used or intended to be used mainly in industry |
0 |
|||||||||||||
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
|||||||||||||
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
|||||||||||||
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
64 |
64 |
||||||||||||
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
|||||||||||||
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
0 |
|||||||||||||
|
8.i. |
Other toxicological or safety evaluations |
0 |
|||||||||||||
|
8.j. |
TOTAL |
3824 |
130 |
150 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
4110 |
CZECH REPUBLIC
Statistical data submitted
The statistical data have been submitted by the “Central Commission for Animal Welfare (Ústřední komise pro ochranu zvířat)”.
Comments of the Czech authorities
Protection of animals and animal welfare in the Czech Republic (CR) is the responsibility of the Ministry of Agriculture (Ministerstvo zemědělství). The Central Commission for Animal Welfare (Ústřední komise pro ochranu zvířat) has changed to the technical advisory board of the Minister of Agriculture. The animal welfare activities are implemented pursuant to Act No. 246/1992 Coll., on the protection of animals against cruelty, as amended. The supervision of these matters has been the responsibility of the Regional Veterinary Administrations’ inspectors in 13 regions of the CR and the Municipal Veterinary Administration in Prague.
Altogether 132 inspections of experiments on animals were carried out in 2008, involving 77,694 animals. In 2 cases a penalty was imposed due to detected shortcomings.
Note: The Czech tables below, which were used for calculating the EU totals in the Sixth Report, do not include animals used by the Czech Academy of Sciences (CAS) due to the death of the responsible person at the time of data collection. However, these additional animals are included in the comments below.
In CAS 49,667 animals (32,995 mice, 10,106 rats, 733 guinea pigs, 56 other rodents, 299 pigs, 2,178 birds, 3,300 fish) were used and should be added to the tables provided below.
Therefore, in 2008 a total of 350,380 animals were used for experimental and other scientific purposes in the CR. It should be pointed out that 40,58% of it is represented by ringed birds (142,200 birds) since pursuant to the relevant Czech legislation even bird ringing is an experiment.
Of the remaining 208,180 animals used for experimental and scientific purposes only 0,02% were cats (45 cats), 0,26% dogs (552 dogs), 0,04% monkeys (80 monkeys), while no apes were used. Rodents and rabbits (62,39%, i.e. 129,887 animals) and fish (27,93%, i.e. 58,136 fish) represent the prevailing majority of animals used.
In the last couple of years the number of experimental animals used in the CR was approximately the same (approximately 220,000 animals excluding ringed birds). Fluctuations in numbers, if any, are caused by experiments using fish and poultry because these experiments are usually conducted on a large group of animals (a flock in houses or stock in water reservoirs).
The use of alternative methods to experiments on animals has been pushed through in the CR. Persons who manage, control and conduct experiments on animals are obliged to seek in the registers of validated alternative methods such methods which are applicable to their experiment. In the experimental project the applicant shall declare in writing that no validated alternative method can be applied for the given purpose.
The training courses for persons who manage, control and conduct experiments on animals comprise also teaching of alternative methods to experiments on animals.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
54776 |
51832 |
2888 |
56 |
|
|
|
1.b. |
Rats (Rattus norvegicus) |
21531 |
20600 |
931 |
|
||
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
1902 |
1902 |
|
|||
|
1.d. |
Hamsters (Mesocricetus ) |
251 |
251 |
|
|||
|
1.e. |
Other Rodents (other Rodentia) |
1233 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
6304 |
6263 |
14 |
27 |
47 |
|
|
1.g. |
Cats (Felis catus) |
45 |
15 |
30 |
|||
|
1.h. |
Dogs (Canis familiaris) |
552 |
478 |
30 |
44 |
18 |
|
|
1.i. |
Ferrets (Mustela putorius furo) |
122 |
122 |
||||
|
1.j. |
Other Carnivores (other Carnivora) |
45 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
378 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
2013 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
174 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
1148 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
799 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
|||||
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
|||||
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
80 |
80 |
59 |
|||
|
1.s. |
Apes (Hominoidea) |
0 |
|||||
|
1.t. |
Other Mammals (other Mammalia) |
1774 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
|
||||
|
1.v. |
Other birds (other Aves) |
148722 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
1012 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
3016 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
54836 |
|
|
|
|
|
|
1.z. |
TOTAL |
300713 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
14326 |
9138 |
2019 |
15795 |
703 |
6172 |
550 |
6073 |
54776 |
|
2.b. |
Rats |
9878 |
4523 |
133 |
1260 |
3270 |
3 |
2359 |
105 |
21531 |
|
2.c. |
Guinea-Pigs |
169 |
545 |
39 |
905 |
132 |
35 |
77 |
1902 |
|
|
2.d. |
Hamsters |
14 |
180 |
57 |
251 |
|||||
|
2.e. |
Other Rodents |
1125 |
83 |
25 |
1233 |
|||||
|
2.f. |
Rabbits |
918 |
467 |
122 |
3533 |
202 |
217 |
780 |
65 |
6304 |
|
2.g. |
Cats |
30 |
15 |
45 |
||||||
|
2.h. |
Dogs |
44 |
335 |
18 |
151 |
2 |
2 |
552 |
||
|
2.i. |
Ferrets |
118 |
4 |
122 |
||||||
|
2.j. |
Other Carnivores |
9 |
36 |
45 |
||||||
|
2.k. |
Horses, donkeys and cross breds |
19 |
30 |
306 |
13 |
10 |
378 |
|||
|
2.l. |
Pigs |
1146 |
208 |
468 |
100 |
8 |
83 |
2013 |
||
|
2.m. |
Goats |
32 |
23 |
119 |
174 |
|||||
|
2.n. |
Sheep |
108 |
100 |
250 |
65 |
625 |
1148 |
|||
|
2.o. |
Cattle |
54 |
29 |
332 |
4 |
162 |
184 |
34 |
799 |
|
|
2.p. |
Prosimians |
0 |
||||||||
|
2.q. |
New World Monkeys |
0 |
||||||||
|
2.r. |
Old World Monkeys |
80 |
80 |
|||||||
|
2.s. |
Apes |
0 |
||||||||
|
2.t. |
Other Mammals |
1774 |
1774 |
|||||||
|
2.u. |
Quail |
0 |
||||||||
|
2.v. |
Other birds |
146422 |
594 |
506 |
746 |
54 |
371 |
29 |
148722 |
|
|
2.w. |
Reptiles |
958 |
54 |
1012 |
||||||
|
2.x. |
Amphibians |
2915 |
101 |
3016 |
||||||
|
2.y. |
Fish |
16894 |
90 |
37402 |
300 |
150 |
54836 |
|||
|
2.z. |
TOTAL |
196805 |
16336 |
2313 |
23328 |
42710 |
7207 |
5048 |
6966 |
300713 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns |
3.10 Other toxico- logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
553 |
8 |
155 |
45 |
761 |
|||||
|
3.b. |
Rats |
947 |
405 |
1825 |
54 |
3231 |
|||||
|
3.c. |
Guinea-Pigs |
71 |
100 |
171 |
|||||||
|
3.d. |
Hamsters |
0 |
|||||||||
|
3.e. |
Other Rodents |
0 |
|||||||||
|
3.f. |
Rabbits |
142 |
24 |
60 |
2 |
12 |
240 |
||||
|
3.g. |
Cats |
0 |
|||||||||
|
3.h. |
Dogs |
151 |
151 |
||||||||
|
3.i. |
Ferrets |
0 |
|||||||||
|
3.j. |
Other Carnivores |
0 |
|||||||||
|
3.k. |
Horses, donkeys and cross breds |
0 |
|||||||||
|
3.l. |
Pigs |
8 |
100 |
108 |
|||||||
|
3.m. |
Goats |
0 |
|||||||||
|
3.n. |
Sheep |
0 |
|||||||||
|
3.o. |
Cattle |
4 |
4 |
||||||||
|
3.p. |
Prosimians |
0 |
|||||||||
|
3.q. |
New World Monkeys |
0 |
|||||||||
|
3.r. |
Old World Monkeys |
0 |
|||||||||
|
3.s. |
Apes |
0 |
|||||||||
|
3.t. |
Other Mammals |
210 |
210 |
||||||||
|
3.u. |
Quail |
0 |
|||||||||
|
3.v. |
Other birds |
349 |
48 |
397 |
|||||||
|
3.w. |
Reptiles |
0 |
|||||||||
|
3.x. |
Amphibians |
0 |
|||||||||
|
3.y. |
Fish |
305 |
677 |
1945 |
549 |
422 |
523 |
32066 |
950 |
37437 |
|
|
3.z. |
TOTAL |
2518 |
1384 |
4085 |
549 |
422 |
625 |
0 |
32177 |
950 |
42710 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
185 |
181 |
6411 |
10073 |
2945 |
19795 |
|
4.b. |
Rats |
2629 |
1865 |
1996 |
1901 |
2803 |
11194 |
|
4.c. |
Guinea-Pigs |
12 |
135 |
147 |
|||
|
4.d. |
Hamsters |
52 |
52 |
||||
|
4.e. |
Other Rodents |
35 |
35 |
||||
|
4.f. |
Rabbits |
134 |
60 |
118 |
281 |
593 |
|
|
4.g. |
Cats |
0 |
|||||
|
4.h. |
Dogs |
39 |
2 |
2 |
42 |
85 |
|
|
4.i. |
Ferrets |
122 |
122 |
||||
|
4.j. |
Other Carnivores |
0 |
|||||
|
4.k. |
Horses, donkeys and cross breds |
7 |
7 |
||||
|
4.l. |
Pigs |
102 |
3 |
537 |
642 |
||
|
4.m. |
Goats |
147 |
147 |
||||
|
4.n. |
Sheep |
18 |
250 |
37 |
305 |
||
|
4.o. |
Cattle |
114 |
114 |
||||
|
4.p. |
Prosimians |
0 |
|||||
|
4.q. |
New World Monkeys |
0 |
|||||
|
4.r. |
Old World Monkeys |
31 |
49 |
80 |
|||
|
4.s. |
Apes |
0 |
|||||
|
4.t. |
Other Mammals |
10 |
10 |
||||
|
4.u. |
Quail |
0 |
|||||
|
4.v. |
Other birds |
212 |
1641 |
1853 |
|||
|
4.w. |
Reptiles |
0 |
|||||
|
4.x. |
Amphibians |
0 |
|||||
|
4.y. |
Fish |
1925 |
1925 |
||||
|
4.z. |
TOTAL |
3138 |
2048 |
8479 |
12927 |
10514 |
37106 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
5884 |
11930 |
17814 |
||||||||
|
5.b. |
Rats |
67 |
1260 |
66 |
1393 |
|||||||
|
5.c. |
Guinea-Pigs |
180 |
741 |
921 |
||||||||
|
5.d. |
Hamsters |
0 |
||||||||||
|
5.e. |
Other Rodents |
0 |
||||||||||
|
5.f. |
Rabbits |
88 |
3490 |
3578 |
||||||||
|
5.g. |
Cats |
15 |
15 |
|||||||||
|
5.h. |
Dogs |
18 |
18 |
|||||||||
|
5.i. |
Ferrets |
0 |
||||||||||
|
5.j. |
Other Carnivores |
0 |
||||||||||
|
5.k. |
Horses, donkeys and cross breds |
292 |
14 |
306 |
||||||||
|
5.l. |
Pigs |
46 |
422 |
468 |
||||||||
|
5.m. |
Goats |
0 |
||||||||||
|
5.n. |
Sheep |
3 |
97 |
100 |
||||||||
|
5.o. |
Cattle |
332 |
332 |
|||||||||
|
5.p. |
Prosimians |
0 |
||||||||||
|
5.q. |
New World Monkeys |
0 |
||||||||||
|
5.r. |
Old World Monkeys |
0 |
||||||||||
|
5.s. |
Apes |
0 |
||||||||||
|
5.t. |
Other Mammals |
0 |
||||||||||
|
5.u. |
Quail |
0 |
||||||||||
|
5.v. |
Other birds |
48 |
458 |
100 |
606 |
|||||||
|
5.w. |
Reptiles |
0 |
||||||||||
|
5.x. |
Amphibians |
0 |
||||||||||
|
5.y. |
Fish |
90 |
90 |
|||||||||
|
5.z. |
TOTAL |
6698 |
18777 |
0 |
66 |
0 |
100 |
25641 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
511 |
192 |
703 |
||||||||
|
6.b. |
Rats |
2755 |
41 |
474 |
3270 |
|||||||
|
6.c. |
Guinea-Pigs |
100 |
32 |
132 |
||||||||
|
6.d. |
Hamsters |
0 |
||||||||||
|
6.e. |
Other Rodents |
0 |
||||||||||
|
6.f. |
Rabbits |
171 |
12 |
19 |
202 |
|||||||
|
6.g. |
Cats |
0 |
||||||||||
|
6.h. |
Dogs |
151 |
151 |
|||||||||
|
6.i. |
Ferrets |
0 |
||||||||||
|
6.j. |
Other Carnivores |
0 |
||||||||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
||||||||||
|
6.l. |
Pigs |
100 |
100 |
|||||||||
|
6.m. |
Goats |
0 |
||||||||||
|
6.n. |
Sheep |
0 |
||||||||||
|
6.o. |
Cattle |
0 |
||||||||||
|
6.p. |
Prosimians |
0 |
||||||||||
|
6.q. |
New World Monkeys |
0 |
||||||||||
|
6.r. |
Old World Monkeys |
0 |
||||||||||
|
6.s. |
Apes |
0 |
||||||||||
|
6.t. |
Other Mammals |
0 |
||||||||||
|
6.u. |
Quail |
0 |
||||||||||
|
6.v. |
Other birds |
670 |
670 |
|||||||||
|
6.w. |
Reptiles |
0 |
||||||||||
|
6.x. |
Amphibians |
0 |
||||||||||
|
6.y. |
Fish |
24468 |
9179 |
3835 |
37482 |
|||||||
|
6.z. |
TOTAL |
28156 |
9264 |
0 |
0 |
0 |
5290 |
42710 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino- genicity |
7.8 Develop- mental toxicity |
7.9 Muta- genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
506 |
155 |
42 |
703 |
||||||||||
|
7.b. |
Rats |
337 |
718 |
12 |
679 |
387 |
115 |
532 |
490 |
3270 |
|||||
|
7.c. |
Guinea-Pigs |
10 |
116 |
6 |
132 |
||||||||||
|
7.d. |
Hamsters |
0 |
|||||||||||||
|
7.e. |
Other Rodents |
0 |
|||||||||||||
|
7.f. |
Rabbits |
97 |
19 |
26 |
60 |
202 |
|||||||||
|
7.g. |
Cats |
0 |
|||||||||||||
|
7.h. |
Dogs |
15 |
80 |
56 |
151 |
||||||||||
|
7.i. |
Ferrets |
0 |
|||||||||||||
|
7.j. |
Other Carnivores |
0 |
|||||||||||||
|
7.k. |
Horses, donkeys and cross breds |
0 |
|||||||||||||
|
7.l. |
Pigs |
100 |
100 |
||||||||||||
|
7.m. |
Goats |
0 |
|||||||||||||
|
7.n. |
Sheep |
0 |
|||||||||||||
|
7.o. |
Cattle |
0 |
|||||||||||||
|
7.p. |
Prosimians |
0 |
|||||||||||||
|
7.q. |
New World Monkeys |
0 |
|||||||||||||
|
7.r. |
Old World Monkeys |
0 |
|||||||||||||
|
7.s. |
Apes |
0 |
|||||||||||||
|
7.t. |
Other Mammals |
0 |
|||||||||||||
|
7.u. |
Quail |
0 |
|||||||||||||
|
7.v. |
Other birds |
670 |
670 |
||||||||||||
|
7.w. |
Reptiles |
0 |
|||||||||||||
|
7.x. |
Amphibians |
0 |
|||||||||||||
|
7.y. |
Fish |
33782 |
3700 |
37482 |
|||||||||||
|
7.z. |
TOTAL |
34134 |
506 |
718 |
107 |
302 |
32 |
759 |
0 |
387 |
115 |
532 |
3700 |
1418 |
42710 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
255 |
506 |
68 |
35 |
11 |
477 |
138 |
1028 |
2518 |
|||||
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
750 |
400 |
12 |
12 |
210 |
1384 |
||||||||
|
8.c. |
Products/substances used or intended to be used mainly in industry |
1067 |
318 |
39 |
255 |
21 |
270 |
387 |
95 |
532 |
975 |
126 |
4085 |
||
|
8.d. |
Products/substances used or intended to be used mainly in the household |
549 |
549 |
||||||||||||
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
422 |
422 |
||||||||||||
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
625 |
625 |
||||||||||||
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
|||||||||||||
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
30421 |
20 |
45 |
1637 |
54 |
32177 |
||||||||
|
8.i. |
Other toxicological or safety evaluations |
950 |
950 |
||||||||||||
|
8.j. |
TOTAL |
33464 |
506 |
718 |
107 |
302 |
32 |
759 |
625 |
387 |
115 |
577 |
3700 |
1418 |
42710 |
DENMARK
Statistical data submitted
The statistical data have been submitted by the “Dyreforsøgstilsynet” (Animal Experiments Inspectorate).
Comments of Danish authorities
None
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
168164 |
119674 |
44406 |
337 |
3747 |
|
|
1.b. |
Rats (Rattus norvegicus) |
75850 |
42343 |
30618 |
687 |
2202 |
|
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
5343 |
703 |
4640 |
0 |
0 |
|
|
1.d. |
Hamsters (Mesocricetus ) |
4 |
4 |
0 |
0 |
0 |
|
|
1.e. |
Other Rodents (other Rodentia) |
1760 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
2931 |
758 |
1044 |
0 |
1129 |
140 |
|
1.g. |
Cats (Felis catus) |
154 |
0 |
17 |
4 |
133 |
0 |
|
1.h. |
Dogs (Canis familiaris) |
271 |
0 |
250 |
0 |
21 |
39 |
|
1.i. |
Ferrets (Mustela putorius furo) |
117 |
97 |
20 |
0 |
0 |
0 |
|
1.j. |
Other Carnivores (other Carnivora) |
101 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
54 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
6863 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
107 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
88 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
939 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.q. |
New World Monkeys (Ceboidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.s. |
Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. |
Other Mammals (other Mammalia) |
243 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
0 |
0 |
0 |
0 |
0 |
|
|
1.v. |
Other birds (other Aves) |
2820 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
221 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
293 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
31245 |
|
|
|
|
|
|
1.z. |
TOTAL |
297568 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
53293 |
82439 |
11900 |
155 |
4923 |
2932 |
1096 |
11426 |
168164 |
|
2.b. |
Rats |
15346 |
45628 |
3244 |
0 |
7269 |
833 |
2628 |
902 |
75850 |
|
2.c. |
Guinea-Pigs |
207 |
2017 |
1695 |
25 |
1311 |
76 |
12 |
0 |
5343 |
|
2.d. |
Hamsters |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
|
2.e. |
Other Rodents |
62 |
1698 |
0 |
0 |
0 |
0 |
0 |
0 |
1760 |
|
2.f. |
Rabbits |
357 |
1808 |
447 |
4 |
218 |
2 |
42 |
53 |
2931 |
|
2.g. |
Cats |
123 |
0 |
0 |
0 |
0 |
10 |
0 |
21 |
154 |
|
2.h. |
Dogs |
1 |
119 |
0 |
0 |
130 |
21 |
0 |
0 |
271 |
|
2.i. |
Ferrets |
97 |
20 |
0 |
0 |
0 |
0 |
0 |
0 |
117 |
|
2.j. |
Other Carnivores |
62 |
39 |
0 |
0 |
0 |
0 |
0 |
0 |
101 |
|
2.k. |
Horses, donkeys and cross breds |
15 |
13 |
7 |
0 |
0 |
0 |
19 |
0 |
54 |
|
2.l. |
Pigs |
2245 |
1862 |
0 |
43 |
648 |
102 |
1029 |
934 |
6863 |
|
2.m. |
Goats |
0 |
93 |
0 |
0 |
0 |
0 |
0 |
14 |
107 |
|
2.n. |
Sheep |
5 |
38 |
26 |
6 |
0 |
0 |
13 |
0 |
88 |
|
2.o. |
Cattle |
616 |
124 |
0 |
18 |
0 |
131 |
50 |
0 |
939 |
|
2.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.t. |
Other Mammals |
233 |
0 |
0 |
0 |
0 |
0 |
10 |
0 |
243 |
|
2.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.v. |
Other birds |
2604 |
111 |
2 |
84 |
6 |
13 |
0 |
0 |
2820 |
|
2.w. |
Reptiles |
198 |
23 |
0 |
0 |
0 |
0 |
0 |
0 |
221 |
|
2.x. |
Amphibians |
92 |
65 |
0 |
0 |
0 |
136 |
0 |
0 |
293 |
|
2.y. |
Fish |
5939 |
16602 |
0 |
0 |
8443 |
0 |
261 |
0 |
31245 |
|
2.z. |
TOTAL |
81499 |
152699 |
17321 |
335 |
22948 |
4256 |
5160 |
13350 |
297568 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns |
3.10 Other toxico- logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
2845 |
0 |
537 |
0 |
0 |
62 |
0 |
439 |
1040 |
4923 |
|
3.b. |
Rats |
4515 |
74 |
0 |
1346 |
0 |
120 |
0 |
127 |
1087 |
7269 |
|
3.c. |
Guinea-Pigs |
1260 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
27 |
1311 |
|
3.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.f. |
Rabbits |
215 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
218 |
|
3.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.h. |
Dogs |
130 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
130 |
|
3.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.l. |
Pigs |
648 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
648 |
|
3.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.v. |
Other birds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
6 |
|
3.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.y. |
Fish |
0 |
0 |
493 |
0 |
0 |
0 |
7950 |
0 |
0 |
8443 |
|
3.z. |
TOTAL |
9613 |
74 |
1030 |
1346 |
0 |
209 |
7950 |
566 |
2160 |
22948 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
2802 |
59758 |
13426 |
35581 |
1150 |
112717 |
|
4.b. |
Rats |
2075 |
34100 |
823 |
19699 |
40 |
56737 |
|
4.c. |
Guinea-Pigs |
269 |
1700 |
0 |
194 |
0 |
2163 |
|
4.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.e. |
Other Rodents |
0 |
1416 |
0 |
282 |
24 |
1722 |
|
4.f. |
Rabbits |
199 |
0 |
1129 |
757 |
21 |
2106 |
|
4.g. |
Cats |
0 |
0 |
0 |
0 |
85 |
85 |
|
4.h. |
Dogs |
21 |
39 |
0 |
80 |
0 |
140 |
|
4.i. |
Ferrets |
0 |
20 |
0 |
97 |
0 |
117 |
|
4.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
15 |
15 |
|
4.l. |
Pigs |
471 |
179 |
0 |
1869 |
111 |
2630 |
|
4.m. |
Goats |
0 |
0 |
87 |
6 |
0 |
93 |
|
4.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.o. |
Cattle |
0 |
0 |
0 |
79 |
36 |
115 |
|
4.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.t. |
Other Mammals |
0 |
0 |
0 |
0 |
130 |
130 |
|
4.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.v. |
Other birds |
64 |
0 |
0 |
0 |
240 |
304 |
|
4.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.x. |
Amphibians |
0 |
151 |
0 |
0 |
0 |
151 |
|
4.y. |
Fish |
0 |
8165 |
0 |
0 |
1180 |
9345 |
|
4.z. |
TOTAL |
5901 |
105528 |
15465 |
58644 |
3032 |
188570 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
155 |
14 |
0 |
0 |
11870 |
16 |
12055 |
||||
|
5.b. |
Rats |
0 |
2408 |
0 |
0 |
836 |
0 |
3244 |
||||
|
5.c. |
Guinea-Pigs |
25 |
0 |
0 |
0 |
1310 |
385 |
1720 |
||||
|
5.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.f. |
Rabbits |
4 |
0 |
0 |
28 |
22 |
397 |
451 |
||||
|
5.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.h. |
Dogs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
7 |
7 |
||||
|
5.l. |
Pigs |
43 |
0 |
0 |
0 |
0 |
0 |
43 |
||||
|
5.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.n. |
Sheep |
6 |
0 |
0 |
0 |
0 |
26 |
32 |
||||
|
5.o. |
Cattle |
18 |
0 |
0 |
0 |
0 |
0 |
18 |
||||
|
5.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.v. |
Other birds |
84 |
0 |
0 |
0 |
0 |
2 |
86 |
||||
|
5.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.y. |
Fish |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.z. |
TOTAL |
335 |
2422 |
0 |
28 |
14038 |
833 |
17656 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
|||||
|
6.a. |
Mice |
667 |
0 |
0 |
0 |
2366 |
1890 |
4923 |
||||
|
6.b. |
Rats |
98 |
0 |
0 |
50 |
4502 |
2619 |
7269 |
||||
|
6.c. |
Guinea-Pigs |
0 |
0 |
0 |
72 |
1188 |
51 |
1311 |
||||
|
6.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.f. |
Rabbits |
0 |
0 |
0 |
0 |
216 |
2 |
218 |
||||
|
6.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.h. |
Dogs |
0 |
0 |
0 |
0 |
130 |
0 |
130 |
||||
|
6.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.l. |
Pigs |
0 |
0 |
0 |
0 |
648 |
0 |
648 |
||||
|
6.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.v. |
Other birds |
6 |
0 |
0 |
0 |
0 |
0 |
6 |
||||
|
6.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
6.y. |
Fish |
493 |
0 |
0 |
0 |
0 |
7950 |
8443 |
||||
|
6.z. |
TOTAL |
1264 |
0 |
0 |
122 |
9050 |
12512 |
22948 |
||||
|
Examples: |
6.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
6.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
6.4 – Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
6.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 6.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus species
|
7.1 Species |
7.2 Acute and sub-acute toxicity testing methods (including limit test) |
7.3 Skin irritation |
7.4 Skin sensitisation |
7.5 Eye irritation |
7.6 Sub- chronic and chronic toxicity |
7.7 Carcino- genicity |
7.8 Develop- mental toxicity |
7.9 Muta- genicity |
7.10 Repro-ductive toxicity |
7.11 Toxicity to aquatic vertebra-tes not included in other columns |
7.12 Other |
7.13 Total |
|||
|
7.2.1. LD50, LC50 |
7.2.2 Other lethal methods |
7.2.3 Non lethal clinical signs methods |
|||||||||||||
|
7.a. |
Mice |
0 |
0 |
1955 |
0 |
931 |
0 |
382 |
0 |
0 |
658 |
45 |
0 |
952 |
4923 |
|
7.b. |
Rats |
0 |
0 |
1146 |
0 |
0 |
0 |
3146 |
0 |
0 |
174 |
2372 |
0 |
431 |
7269 |
|
7.c. |
Guinea-Pigs |
0 |
0 |
1223 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
88 |
1311 |
|
7.d. |
Hamsters |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.f. |
Rabbits |
0 |
0 |
46 |
19 |
0 |
3 |
39 |
0 |
0 |
0 |
109 |
0 |
2 |
218 |
|
7.g. |
Cats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.h. |
Dogs |
0 |
0 |
0 |
0 |
0 |
0 |
126 |
0 |
0 |
0 |
0 |
0 |
4 |
130 |
|
7.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.l. |
Pigs |
0 |
0 |
8 |
12 |
0 |
0 |
600 |
0 |
0 |
0 |
28 |
0 |
0 |
648 |
|
7.m. |
Goats |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.o. |
Cattle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.v. |
Other birds |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
|
7.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7.y. |
Fish |
199 |
7950 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
294 |
0 |
8443 |
|
7.z. |
TOTAL |
199 |
7950 |
4384 |
31 |
931 |
3 |
4293 |
0 |
0 |
832 |
2554 |
294 |
1477 |
22948 |
TABLE 8:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Types of tests versus products
|
8.1 Products |
8.2 Acute and sub-acute toxicity testing methods (including limit test) |
8.3 Skin irritation |
8.4 Skin sensitisation |
8.5 Eye irritation |
8.6 Sub- chronic and chronic toxicity |
8.7 Carcino genicity |
8.8 Develop- mental toxicity |
8.9 Muta- genicity |
8.10 Repro-ductive toxicity |
8.11 Toxicity to aquatic vertebra-tes not included in other columns |
8.12 Other |
8.13 Total |
|||
|
8.2.1. LD50, LC50 |
8.2.2 Other lethal methods |
8.2.3 Non lethal clinical signs methods |
|||||||||||||
|
8.a. |
Products/substances or devices for human medicine and dentistry and for veterinary medicine |
125 |
0 |
4027 |
31 |
407 |
0 |
4366 |
0 |
0 |
148 |
401 |
0 |
108 |
9613 |
|
8.b. |
Products/substances used or intended to be used mainly in agriculture |
0 |
0 |
0 |
0 |
0 |
0 |
18 |
0 |
0 |
0 |
56 |
0 |
0 |
74 |
|
8.c. |
Products/substances used or intended to be used mainly in industry |
199 |
0 |
0 |
0 |
188 |
0 |
294 |
0 |
0 |
0 |
45 |
0 |
304 |
1030 |
|
8.d. |
Products/substances used or intended to be used mainly in the household |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1016 |
0 |
330 |
1346 |
|
8.e. |
Products/substances used or intended to be used mainly as cosmetics or toiletries |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8.f. |
Products/substances used or intended to be used mainly as additives in food for human consumption |
0 |
0 |
0 |
0 |
0 |
3 |
120 |
0 |
0 |
0 |
0 |
0 |
86 |
209 |
|
8.g. |
Products/substances used or intended to be used mainly as additives in food for animal consumption |
0 |
7950 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7950 |
|
8.h. |
Potential or actual contaminants in the general environment which do not appear in other columns |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
566 |
0 |
0 |
0 |
566 |
|
8.i. |
Other toxicological or safety evaluations |
0 |
0 |
21 |
0 |
336 |
0 |
0 |
0 |
0 |
118 |
1041 |
0 |
644 |
2160 |
|
8.j. |
TOTAL |
324 |
7950 |
4048 |
31 |
931 |
3 |
4798 |
0 |
0 |
832 |
2559 |
0 |
1472 |
22948 |
GERMANY
Statistical data submitted
The statistical data have been submitted by the "Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft" (Federal Ministry for Consumer protection, Food and Agriculture).
Comments of German authorities
The German Government's aim is to reduce to an unavoidable minimum the number of animals used for experimental and other scientific purposes. In the current state of the art, however, despite the increased use of alternative methods it is not yet possible to dispense with animal experiments entirely. This applies to medical research in particular.
Within the EU, Germany is making a major contribution towards the development of test methods which do not involve animal experiments. A leading part in this process is played both by the Federal Ministry of Education and Research, with its scheme to promote the development of methods to replace animal experiments and by the Central Office for the registration and assessment of methods replacing and supplementing animal experiments, which this year is celebrating its 20th anniversary.
Compared with the previous year, in 2008 in Germany the number of vertebrates used for experimental and other scientific purposes increased by 2,1% to 2,021,782. Whereas the number of mice used increased by 135,459 the number of fish used fell by 95,565.
At almost 87%, rodents constitute the largest group of animals used in experiments. In particular, mice account for 65% and rats for 19%.
The next largest groups comprise rabbits at 4,8%, fish at 3,3% and birds at 2,8%. All other species taken together account for 2,2% of the animals used.
Compared with the previous year, the number of Old World monkeys, New World monkeys and prosimians fell by 152 to 2,263. The largest proportion of these animals (1,858) was used for toxicological tests and other safety tests on products and appliances for human, dental and veterinary medicine. Apes were not used.
Compared with 2007, the number of dogs and cats used fell by 340; the total number corresponded roughly to the numbers for 2000 to 2006.
For basic biological research the number of fish used fell by 88,760 and the number of rats by 18,122. By contrast, the number of mice rose by 41,775 and the number of amphibians by 5,676. In total, 68,519 fewer animals were used in basic biological research (-7,3%).
For the research and development of products and for the manufacture and/or quality control of products for human, dental and veterinary medicine, 858,395 animals were used – an increase of
122,052 compared with the previous year. By contrast, in 2007, 97,770 fewer animals were used than in 2006. In the years 2001 to 2005 the number of animals used for these purposes was likewise within this range.
For toxicological tests and other safety tests on products and appliances for human, dental and veterinary medicine, 8,432 more animals were required than in 2007.
For products or substances used primarily in cosmetics or toiletries, no toxicological tests were carried out on animals in 2008 in Germany.
The proportion of animals used for research into human or animal diseases fell in 2008 compared with the previous year from 58,5% to 56,1%.
24,6% of the animals were used for legally required experiments in the manufacture or quality control of products for human, dental or veterinary medicine and/or for toxicological safety tests. Their proportion therefore increased by 5,0%.
TABLE 1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN
Origin versus species
|
1.1 Species |
1.2 Total |
1.3 Animals coming from registered breeding or supplying establishments within the reporting country |
1.4 Animals coming from elsewhere in the EC |
1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) |
1.6 Animals coming from other origins |
1.7 Re-used animals |
|
|
1.a. |
Mice (Mus musculus) |
1.314.493 |
1.167.335 |
129.636 |
10.760 |
6.762 |
|
|
1.b. |
Rats (Rattus norvegicus) |
390.853 |
305.309 |
79.003 |
5.395 |
1.146 |
|
|
1.c. |
Guinea-Pigs (Cavia porcellus) |
35.870 |
35.624 |
246 |
0 |
0 |
|
|
1.d. |
Hamsters (Mesocricetus ) |
7.061 |
6.782 |
149 |
0 |
130 |
|
|
1.e. |
Other Rodents (other Rodentia) |
8.392 |
|
|
|
|
|
|
1.f. |
Rabbits (Oryctolagus cuniculus) |
97.938 |
97.313 |
621 |
4 |
0 |
9.076 |
|
1.g. |
Cats (Felis catus) |
798 |
246 |
294 |
0 |
258 |
303 |
|
1.h. |
Dogs (Canis familiaris) |
4.450 |
1.911 |
1.536 |
0 |
1.003 |
1.081 |
|
1.i. |
Ferrets (Mustela putorius furo) |
55 |
11 |
44 |
0 |
0 |
0 |
|
1.j. |
Other Carnivores (other Carnivora) |
410 |
|
|
|
|
|
|
1.k. |
Horses, donkeys and cross breds (Equidae) |
584 |
|
|
|
|
|
|
1.l. |
Pigs (Sus) |
12.361 |
|
|
|
|
|
|
1.m. |
Goats (Capra) |
531 |
|
|
|
|
|
|
1.n. |
Sheep (Ovis) |
4.638 |
|
|
|
|
|
|
1.o. |
Cattle (Bos) |
6.252 |
|
|
|
|
|
|
1.p. |
Prosimians (Prosimia) |
543 |
0 |
543 |
0 |
0 |
0 |
|
1.q. |
New World Monkeys (Ceboidea) |
305 |
252 |
48 |
5 |
0 |
63 |
|
1.r. |
Old World Monkeys (Cercopithecoidea) |
1.415 |
102 |
205 |
0 |
1.108 |
396 |
|
1.s. |
Apes (Hominoidea) |
0 |
0 |
0 |
0 |
0 |
0 |
|
1.t. |
Other Mammals (other Mammalia) |
541 |
|
|
|
|
|
|
1.u. |
Quail (Coturnix coturnix) |
1.803 |
1.803 |
0 |
0 |
0 |
|
|
1.v. |
Other birds (other Aves) |
53.986 |
|
|
|
|
|
|
1.w. |
Reptiles (Reptilia) |
192 |
|
|
|
|
|
|
1.x. |
Amphibians (Amphibia) |
10.815 |
|
|
|
|
|
|
1.y. |
Fish (Pisces) |
67.496 |
|
|
|
|
|
|
1.z. |
TOTAL |
2.021.782 |
|
|
|
|
|
Note 1:Column 1.5 concerns only those Member Countries of the Council of Europe which, at the beginning of the reporting period, are Parties to the Convention ETS 123. Thus an updated list of those countries has to be used when filling in this column.
Note 2:Only the white boxes need to be completed.
Note 3:The number of re-used animals in column 1.7 should be excluded from the total in the column 1.2
TABLE 2:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES
Purpose versus species
|
2.1 Species |
2.2 Biological studies of a fundamental nature |
2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) |
2.4 Production and quality control of products and devices for human medicine and dentistry |
2.5 Production and quality control of products and devices for veterinary medicine |
2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) |
2.7 Diagnosis of disease |
2.8 Education and training |
2.9 Other |
2.10 Total |
|
|
2.a. |
Mice |
723.037 |
273.935 |
148.754 |
41.668 |
75.985 |
7.855 |
26.200 |
17.059 |
1.314.493 |
|
2.b. |
Rats |
74.880 |
180.418 |
51.412 |
10.468 |
53.312 |
1.609 |
16.248 |
2.506 |
390.853 |
|
2.c. |
Guinea-Pigs |
936 |
6.002 |
16.870 |
3.700 |
6.623 |
18 |
616 |
1.105 |
35.870 |
|
2.d. |
Hamsters |
2.036 |
2.822 |
16 |
1.331 |
40 |
52 |
295 |
469 |
7.061 |
|
2.e. |
Other Rodents |
3.497 |
3.934 |
0 |
0 |
0 |
17 |
391 |
553 |
8.392 |
|
2.f. |
Rabbits |
2.453 |
5.387 |
50.713 |
1.809 |
4.483 |
791 |
196 |
32.106 |
97.938 |
|
2.g. |
Cats |
79 |
547 |
39 |
10 |
98 |
0 |
13 |
12 |
798 |
|
2.h. |
Dogs |
193 |
1.003 |
0 |
939 |
1.935 |
189 |
161 |
30 |
4.450 |
|
2.i. |
Ferrets |
42 |
0 |
0 |
2 |
0 |
0 |
1 |
10 |
55 |
|
2.j. |
Other Carnivores |
15 |
0 |
0 |
311 |
0 |
80 |
0 |
4 |
410 |
|
2.k. |
Horses, donkeys and cross breds |
346 |
121 |
0 |
2 |
0 |
75 |
39 |
1 |
584 |
|
2.l. |
Pigs |
2.633 |
5.918 |
29 |
447 |
352 |
693 |
2.079 |
210 |
12.361 |
|
2.m. |
Goats |
225 |
271 |
11 |
2 |
4 |
10 |
2 |
6 |
531 |
|
2.n. |
Sheep |
692 |
1.150 |
2.151 |
116 |
3 |
167 |
216 |
143 |
4.638 |
|
2.o. |
Cattle |
4.295 |
528 |
22 |
436 |
33 |
622 |
282 |
34 |
6.252 |
|
2.p. |
Prosimians |
0 |
0 |
0 |
0 |
543 |
0 |
0 |
0 |
543 |
|
2.q. |
New World Monkeys |
49 |
91 |
0 |
0 |
147 |
0 |
0 |
18 |
305 |
|
2.r. |
Old World Monkeys |
43 |
91 |
0 |
0 |
1.168 |
2 |
10 |
101 |
1.415 |
|
2.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.t. |
Other Mammals |
495 |
6 |
4 |
0 |
0 |
0 |
7 |
29 |
541 |
|
2.u. |
Quail |
0 |
0 |
0 |
0 |
1.786 |
0 |
17 |
0 |
1.803 |
|
2.v. |
Other birds |
7.095 |
29.863 |
307 |
11.714 |
885 |
2.245 |
462 |
1.415 |
53.986 |
|
2.w. |
Reptiles |
151 |
21 |
0 |
0 |
0 |
0 |
20 |
0 |
192 |
|
2.x. |
Amphibians |
9.477 |
234 |
0 |
0 |
4 |
0 |
1.064 |
36 |
10.815 |
|
2.y. |
Fish |
34.405 |
2.730 |
0 |
40 |
23.853 |
2.421 |
3.571 |
476 |
67.496 |
|
2.z. |
TOTAL |
867.074 |
515.072 |
270.328 |
72.995 |
171.254 |
16.846 |
51.890 |
56.323 |
2.021.782 |
TABLE 3:
NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Products versus species
|
3.1 Species |
3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine |
3.3 Products/ substances used or intended to be used mainly in agriculture |
3.4 Products/ substances used or intended to be used mainly in industry |
3.5 Products/ substances used or intended to be used mainly in the household |
3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries |
3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption |
3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption |
3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns |
3.10 Other toxico- logical or safety evaluations |
3.11 Total |
|
|
3.a. |
Mice |
61.040 |
4.146 |
10.375 |
0 |
0 |
0 |
0 |
217 |
207 |
75.985 |
|
3.b. |
Rats |
33.080 |
8.284 |
11.425 |
16 |
0 |
0 |
0 |
239 |
268 |
53.312 |
|
3.c. |
Guinea-Pigs |
3.613 |
1.449 |
1.482 |
0 |
0 |
0 |
0 |
0 |
79 |
6.623 |
|
3.d. |
Hamsters |
40 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
40 |
|
3.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.f. |
Rabbits |
2.861 |
952 |
633 |
0 |
0 |
0 |
0 |
0 |
37 |
4.483 |
|
3.g. |
Cats |
88 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
98 |
|
3.h. |
Dogs |
1.902 |
20 |
8 |
0 |
0 |
0 |
0 |
0 |
5 |
1.935 |
|
3.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.l. |
Pigs |
352 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
352 |
|
3.m. |
Goats |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
|
3.n. |
Sheep |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
|
3.o. |
Cattle |
33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
33 |
|
3.p. |
Prosimians |
543 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
543 |
|
3.q. |
New World Monkeys |
147 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
147 |
|
3.r. |
Old World Monkeys |
1.168 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.168 |
|
3.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.u. |
Quail |
0 |
1.786 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.786 |
|
3.v. |
Other birds |
182 |
577 |
0 |
0 |
0 |
0 |
44 |
0 |
82 |
885 |
|
3.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
|
3.y. |
Fish |
3.855 |
14.681 |
2.367 |
0 |
0 |
0 |
80 |
2.870 |
0 |
23.853 |
|
3.z. |
TOTAL |
108.907 |
31.899 |
26.290 |
16 |
0 |
0 |
124 |
3.326 |
692 |
171.254 |
TABLE 4:
NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL DISEASES
Main categories versus species
|
4.1 Species |
4.2 Human cardiovascular diseases |
4.3 Human nervous and mental disorders |
4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) |
4.5 Other human diseases |
4.6 Studies specific to animal diseases |
4.7 Total |
|
|
4.a. |
Mice |
60.950 |
105.707 |
107.646 |
388.614 |
5.404 |
668.321 |
|
4.b. |
Rats |
16.279 |
26.241 |
4.369 |
87.061 |
1.014 |
134.964 |
|
4.c. |
Guinea-Pigs |
130 |
47 |
0 |
4.271 |
239 |
4.687 |
|
4.d. |
Hamsters |
387 |
825 |
98 |
2.531 |
45 |
3.886 |
|
4.e. |
Other Rodents |
0 |
814 |
0 |
2.623 |
1.439 |
4.876 |
|
4.f. |
Rabbits |
758 |
106 |
304 |
2.413 |
194 |
3.775 |
|
4.g. |
Cats |
0 |
40 |
0 |
0 |
527 |
567 |
|
4.h. |
Dogs |
3 |
0 |
75 |
84 |
765 |
927 |
|
4.i. |
Ferrets |
0 |
0 |
0 |
35 |
0 |
35 |
|
4.j. |
Other Carnivores |
0 |
0 |
0 |
2 |
80 |
82 |
|
4.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
43 |
294 |
337 |
|
4.l. |
Pigs |
447 |
7 |
10 |
2.170 |
2.359 |
4.993 |
|
4.m. |
Goats |
0 |
29 |
0 |
203 |
10 |
242 |
|
4.n. |
Sheep |
59 |
48 |
0 |
528 |
919 |
1.554 |
|
4.o. |
Cattle |
9 |
21 |
0 |
79 |
4.603 |
4.712 |
|
4.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.q. |
New World Monkeys |
0 |
21 |
0 |
26 |
0 |
47 |
|
4.r. |
Old World Monkeys |
4 |
16 |
0 |
80 |
0 |
100 |
|
4.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.t. |
Other Mammals |
0 |
44 |
0 |
42 |
0 |
86 |
|
4.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
|
4.v. |
Other birds |
118 |
48 |
0 |
2.239 |
7.706 |
10.111 |
|
4.w. |
Reptiles |
0 |
10 |
0 |
0 |
47 |
57 |
|
4.x. |
Amphibians |
224 |
56 |
0 |
468 |
0 |
748 |
|
4.y. |
Fish |
1.768 |
958 |
131 |
3.913 |
5.368 |
12.138 |
|
4.z. |
TOTAL |
81.136 |
135.038 |
112.633 |
497.425 |
31.013 |
857.245 |
TABLE 5:
NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE
Regulatory requirements versus species
|
5.1 Species |
5.2 National legislation specific to a single EC Member State 1) |
5.3 EC legislation including European Pharmacopoeia (requirements) |
5.4 Member Country of Council of Europe (but not EC) legislation 2) |
5.5 Other legislation |
5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 |
5.7 No regulatory requirements |
5.8 Total |
|||||
|
5.a. |
Mice |
0 |
174.107 |
0 |
850 |
11.320 |
4.145 |
190.422 |
||||
|
5.b. |
Rats |
0 |
61.747 |
0 |
0 |
0 |
133 |
61.880 |
||||
|
5.c. |
Guinea-Pigs |
0 |
19.743 |
0 |
512 |
0 |
315 |
20.570 |
||||
|
5.d. |
Hamsters |
0 |
1.347 |
0 |
0 |
0 |
0 |
1.347 |
||||
|
5.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.f. |
Rabbits |
0 |
42.765 |
0 |
0 |
8.697 |
1.060 |
52.522 |
||||
|
5.g. |
Cats |
0 |
39 |
0 |
0 |
0 |
10 |
49 |
||||
|
5.h. |
Dogs |
0 |
217 |
0 |
0 |
680 |
42 |
939 |
||||
|
5.i. |
Ferrets |
0 |
2 |
0 |
0 |
0 |
0 |
2 |
||||
|
5.j. |
Other Carnivores |
0 |
311 |
0 |
0 |
0 |
0 |
311 |
||||
|
5.k. |
Horses, donkeys and cross breds |
0 |
2 |
0 |
0 |
0 |
0 |
2 |
||||
|
5.l. |
Pigs |
0 |
436 |
0 |
0 |
0 |
40 |
476 |
||||
|
5.m. |
Goats |
0 |
0 |
0 |
0 |
2 |
11 |
13 |
||||
|
5.n. |
Sheep |
0 |
0 |
0 |
0 |
58 |
2.209 |
2.267 |
||||
|
5.o. |
Cattle |
0 |
412 |
0 |
0 |
0 |
46 |
458 |
||||
|
5.p. |
Prosimians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
||||
|
5.u. |
Quail |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.v. |
Other birds |
0 |
1.005 |
0 |
0 |
10.158 |
858 |
12.021 |
||||
|
5.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
|
5.y. |
Fish |
0 |
40 |
0 |
0 |
0 |
0 |
40 |
||||
|
5.z. |
TOTAL |
0 |
302.173 |
0 |
1.362 |
30.915 |
8.873 |
343.323 |
||||
|
Examples: |
5.2 – France is testing due to a UK (or FR) specific requirement |
Note: |
columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and |
|||||||||
|
5.3 - UK is testing according to EC legislation |
not to the body which has issued the actual test method, guideline or protocol. |
|||||||||||
|
5.4 - Spain is testing due to a Norwegian requirement |
Example: |
a test required by French legislation and carried out in Belgium according to an |
||||||||||
|
5.5 – Poland is testing due to a US specific requirement |
ISO protocol must be coded as a national (FR) legislative requirement and be |
|||||||||||
|
5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) |
entered into column 5.2 in the tables submitted by Belgium. |
|||||||||||
|
Footnotes: |
1) |
EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
||||||||||
|
2) |
Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine |
|||||||||||
TABLE 6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS
Regulatory requirements versus species
|
6.1 Species |
6.2 National legislation specific to a single EC Member State 1) |
6.3 EC legislation including European Pharmacopoeia (requirements) |
6.4 Member Country of Council of Europe (but not EC) legislation 2) |
6.5 Other legislation |
6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 |
6.7 No regulatory requirements |
6.8 Total |
||||
|
6.a. |
Mice |
153 |
55.706 |
0 |
537 |
16.213 |
3.376 |
75.985 |
|||
|
6.b. |
Rats |
110 |
27.852 |
10 |
16 |
21.608 |
3.716 |
53.312 |
|||
|
6.c. |
Guinea-Pigs |
0 |
4.117 |
0 |
0 |
2.503 |
3 |
6.623 |
|||
|
6.d. |
Hamsters |
0 |
40 |
0 |
0 |
0 |
0 |
40 |
|||
|
6.e. |
Other Rodents |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
6.f. |
Rabbits |
0 |
3.515 |
0 |
0 |
891 |
77 |
4.483 |
|||
|
6.g. |
Cats |
14 |
74 |
0 |
0 |
0 |
10 |
98 |
|||
|
6.h. |
Dogs |
36 |
777 |
0 |
0 |
1.093 |
29 |
1.935 |
|||
|
6.i. |
Ferrets |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
6.j. |
Other Carnivores |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
6.k. |
Horses, donkeys and cross breds |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
6.l. |
Pigs |
0 |
205 |
0 |
0 |
135 |
12 |
352 |
|||
|
6.m. |
Goats |
0 |
0 |
0 |
0 |
4 |
0 |
4 |
|||
|
6.n. |
Sheep |
0 |
0 |
0 |
0 |
0 |
3 |
3 |
|||
|
6.o. |
Cattle |
0 |
33 |
0 |
0 |
0 |
0 |
33 |
|||
|
6.p. |
Prosimians |
0 |
543 |
0 |
0 |
0 |
0 |
543 |
|||
|
6.q. |
New World Monkeys |
0 |
0 |
0 |
0 |
147 |
0 |
147 |
|||
|
6.r. |
Old World Monkeys |
0 |
0 |
0 |
0 |
1.168 |
0 |
1.168 |
|||
|
6.s. |
Apes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
6.t. |
Other Mammals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
6.u. |
Quail |
0 |
320 |
0 |
0 |
1.466 |
0 |
1.786 |
|||
|
6.v. |
Other birds |
0 |
320 |
0 |
0 |
483 |
82 |
885 |
|||
|
6.w. |
Reptiles |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
|
6.x. |
Amphibians |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
|||
|
6.y. |
Fish |
1.270 | |||||||||