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

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

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

Products/substances used or intended to be used mainly as cosmetics or toiletries

Products/substances used or intended to be used mainly in the household

Products/substances used or intended to be used mainly in industry

Products/substances used or intended to be used mainly in agriculture

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

Potential or actual contami-nants in the general envi-ronment which do not appear in other columns

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

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

Products/ substances used or intended to be used mainly as cosmetics or toiletries

Products/ substances used or intended to be used mainly in the household

Products/ substances used or intended to be used mainly in industry

Products/ substances used or intended to be used mainly in agriculture

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

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

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

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

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

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.

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

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

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

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.

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.

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

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

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

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 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.

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

These establishments can be categorized as follows:

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

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

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.

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

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.

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.

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.

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.

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

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.

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

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

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

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

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

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

Products/substances used or intended to be used mainly as cosmetics or toiletries

Products/substances used or intended to be used mainly in the household

Products/substances used or intended to be used mainly in industry

Products/substances used or intended to be used mainly in agriculture

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

Potential or actual contami-nants in the general envi-ronment which do not appear in other columns

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

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

Products/ substances used or intended to be used mainly as cosmetics or toiletries

Products/ substances used or intended to be used mainly in the household

Products/ substances used or intended to be used mainly in industry

Products/ substances used or intended to be used mainly in agriculture

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

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

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

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

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

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.

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

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

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

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

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

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

Products/substances used or intended to be used mainly as cosmetics or toiletries

Products/substances used or intended to be used mainly in the household

Products/substances used or intended to be used mainly in industry

Products/substances used or intended to be used mainly in agriculture

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

Potential or actual contami- nents in the general envi- ronment which do not appear in other columns

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

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

Products/ substances used or intended to be used mainly as cosmetics or toiletries

Products/ substances used or intended to be used mainly in the household

Products/ substances used or intended to be used mainly in industry

Products/ substances used or intended to be used mainly in agriculture

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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.

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

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

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

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)

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

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

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

Products/substances used or intended to be used mainly as cosmetics or toiletries

Products/substances used or intended to be used mainly in the household

Products/substances used or intended to be used mainly in industry

Products/substances used or intended to be used mainly in agriculture

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

Potential or actual contami-nants in the general envi-ronment which do not appear in other columns

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

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

Products/ substances used or intended to be used mainly as cosmetics or toiletries

Products/ substances used or intended to be used mainly in the household

Products/ substances used or intended to be used mainly in industry

Products/ substances used or intended to be used mainly in agriculture

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

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

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

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

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

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.

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

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

No animals were used in the testing of cosmetic products.

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

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.

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.

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%)

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.

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

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

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

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

Products/substances used or intended to be used mainly as cosmetics or toiletries

Products/substances used or intended to be used mainly in the household

Products/substances used or intended to be used mainly in industry

Products/substances used or intended to be used mainly in agriculture

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

Potential or actual contami-nants in the general envi-ronment which do not appear in other columns

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

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

Products/ substances used or intended to be used mainly as cosmetics or toiletries

Products/ substances used or intended to be used mainly in the household

Products/ substances used or intended to be used mainly in industry

Products/ substances used or intended to be used mainly in agriculture

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

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

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

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

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

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.

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

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

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

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

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

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.

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

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

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.

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

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

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

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

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:

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

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

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

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

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

Products/substances used or intended to be used mainly as cosmetics or toiletries

Products/substances used or intended to be used mainly in the household

Products/substances used or intended to be used mainly in industry

Products/substances used or intended to be used mainly in agriculture

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

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

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

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

Products/ substances used or intended to be used mainly as cosmetics or toiletries

Products/ substances used or intended to be used mainly in the household

Products/ substances used or intended to be used mainly in industry

Products/ substances used or intended to be used mainly in agriculture

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

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

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

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

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

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.

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

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

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

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

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

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

Products/substances used or intended to be used mainly as cosmetics or toiletries

Products/substances used or intended to be used mainly in the household

Products/substances used or intended to be used mainly in industry

Products/substances used or intended to be used mainly in agriculture

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

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

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and

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

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

ISO protocol must be coded as a national (FR) legislative requirement and be

a test required by French legislation and carried out in Belgium according to an

not to the body which has issued the actual test method, guideline or protocol.

columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and

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

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

Potential or actual contami- nents in the general envi- ronment which do not appear in other columns

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

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

Products/ substances used or intended to be used mainly as cosmetics or toiletries

Products/ substances used or intended to be used mainly in the household

Products/ substances used or intended to be used mainly in industry

Products/ substances used or intended to be used mainly in agriculture

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

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

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

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

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

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.

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

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

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.

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).

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.

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.

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.

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

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

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

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

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





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, 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 and 1999, 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 and 2005 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, 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 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



Class of species 1996(*) 1999 2002(**) 2005(***) 2008(****) % Rodents-rabbits 81,3 86,9 78,0 77,5 82,2, % Cold-blooded animals 12,9 6,6 15,4 15, 9,6 % Birds 4,7 5 5,4 6,4 % Artio and Perissodactyla 1,2 1,2 1,1 1,4 (*) 14 Member States reporting for 1996, one for 1997 (**) 14 Member States reporting for 2002, one for 2001

(***) 24 Member States reporting for 2005, one for 2004 (****) 27 Member States reporting for 2008, one for 2007 Overall, the percentage of rodents and rabbits shows some fluctuation, but remains close to 80%. For cold-blooded animals the proportion used in 1996, in 2002 and 2005 is between 10 to 15%. In 2008 the use of cold-blooded animals has dropped considerably to below 10%. However, in 1999 a much lower percentage of 6,6% was observed. Birds representing the third largest percentage of animals used, seems to be in constant increase over the years from 4 to 6,4%. The group of horses, donkeys and cross-bred animals (artiodactyla) and pigs, goats, sheep and cattle (perissodactyla) fluctuates at around 1%. Contrary to what would have been expected, the effect of the inclusion of the data of new Member States since 2005 i.e. Bulgaria and Romania, did not lead to an increase in the total number of animals, on the contrary, there is a decrease of more than 116,500 animals. Table 1.0 contains a comparison of the change that has taken place since 2008 for each species, expressed in number of animals per species, between EU 27 (data from 2008) and EU 25 (data from 2005) (first three columns) and in percentage per species (fourth column). The second half is a comparison between EU 25 (data of 2008 without Romania and Bulgaria)



Table 1.0 : Changes in species number and proportion between 2005 and 2008 Species Number of animals

in EU 25

2005 Number of animals

in EU 27

2008 Change since 2005 % change by species Change since 2005 Number of animals

EU 25 2008 excl. RO,BG % change by species 1.a Mice (Mus musculus) 6430346 7122188 691842 9,71 630992 7061338 8,94 1.b Rats (Rattus norvegicus) 2336032 2121727 -214305 -10,10 -223989 2112043 -10,61 1.c Guinea-Pigs (Cavia porcellus) 257307 220985 -36322 -16,44 -46774 210533 -22,22 1.d Hamsters (Mesocricetus ) 31535 32739 1204 3,68 759 32294 2,35 1.e Other Rodents (other Rodentia) 64474 39506 -24968 -63,20 -24968 39506 -63,20 1.f Rabbits (Oryctolagus cuniculus) 312681 333213 20532 6,16 17514 330195 5,30 1.g Cats (Felis catus) 3898 4088 190 4,65 179 4077 4,39 1.h Dogs (Canis familiaris) 24119 21315 -2804 -13,16 -2819 21300 -13,23 1.i Ferrets (Mustela putorius furo) 2690 3208 518 16,15 518 3208 16,15 1.j Other Carnivores 8711 2853 -5858 -205,33 -5858 2853 -205,33 1.k Horses, donkeys and cross breds (Equidae) 5312 5976 664 11,11 633 5945 10,65 1.l Pigs (Sus) 66305 92813 26508 28,56 26369 92674 28,45 1.m Goats (Capra) 2146 3840 1694 44,11 1614 3760 42,93 1.n Sheep (Ovis) 30021 30190 169 0,56 -212 29809 -0,71 1.o Cattle (Bos) 36271 33952 -2319 -6,83 -2448 33823 -7,24 1.p Prosimians (Prosimia) 677 1261 584 46,31 584 1261 46,31 1.q New World Monkeys (Ceboidea) 1564 904 -660 -73,01 -660 904 -73,01 -1.r Old World Monkeys (Cercopithecoidea) 8208 7404 -804 -10,86 -804 7404 -10,86 1.s Apes (Hominoidea) 0 0 0 0 0 0 0 1.t Other Mammals (other Mammalia) 9950 5704 -4246 -74,44 -4246 5704 -74,44 1.u Quail (Coturnix coturnix) 9246 9626 380 3,95 371 9617 3,86 1.v Other birds (other Aves) 649813 754485 104672 13,87 101999 751812 13,57 1.w Reptiles (Reptilia) 2477 4101 1624 39,60 1624 4101 39,60 1.x Amphibians (Amphibia) 74620 61789 -12831 -20,77 -17631 56989 -30,94 1.y Fish (Pisces) 1749178 1087155 -662023 -60,89 -662073 1087105 -60,90 1.z TOTAL 12117583 12001022 -116561 -0,97 -209328 11908255 -1,76 There is an increase in the number of mice used since 2005 of 691,842 which is 9,71% of the total number of mice used in 2008 and a decrease for rats and fish. The largest change in 2008, increase in the use of mice, is almost entirely compensated for by the decrease in the use of fish. The total number of pigs, goats, prosimians, and reptiles has increased by between 28 - 46%. The total number of rats, guinea-pigs, other rodents, dogs, cattle and other mammals as well as amphibians and fish used has decreased substantially since the last report. When expressed in percentages these decreases range from more than 70% to around 10%. The largest percentile change has, however, been noted in the decrease of the use of other carnivores. However, these species are not used in great numbers (from 8,711 to 2,853). There is also a large decrease of 75% in the total number of 'other mammals'. It is also worth noting the large decrease in the use of new world monkeys of 73% as well as a decrease of 11% of old world monkeys. Prosimian use overall, however, has increased by 46%. For species used in greater numbers, significant increases occurred in 2008 for mice, rabbits, pigs and 'other birds' where percentage changes ranged from 5% to 28%. The following animals which are normally used in fewer numbers show an increase in use: ferrets (16%), horses, donkeys and cross-breeds (11%), goats (44%) and reptiles (39%). As in 2002 and 2005, no great apes were used for experimental or other scientific purposes in 2008. Member States provided examples of the type of species covered by category 'other' as follows: Other rodents: gerbils, old world jerboas (Jaculus jaculus); chinchillas, beavers, ground squirrels, hamsters, grey dwarf hamsters (Cricetulus migratorius) and different species of mice. Other carnivores: wild-life species used for zoological and ecological studies e.g. foxes, badgers, seals, otters and fitchew. Other mammals: boars, bats and shrews, llamas, moles, European bison and red deer.

Other birds: mainly Japanese Quail (coturnix japonica) and bob-white quail, poultry species, and zebra finches, canaries, parakeets, parrots and farmed avian species for example, chickens. In the three columns in the second half of the table, the addition of data from Bulgaria, Romania has virtually no effect on the proportional changes between the species. Romania has little effect on the proportional changes between the species ranging from no change to very marginal variations per species. However, there is a net decrease of guinea pigs – 4%, and 10% for amphibians, when data from Bulgaria and Romania are excluded. able 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