Protection of animals used for experimental purposes
ACT
Council 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 [See amending acts].
SUMMARY
Directive 86/609/EEC
Some disparities existed between the national laws in force for the protection of animals used for certain experimental purposes. These disparities had to be harmonised in order to ensure the smooth functioning of the common market.
This Directive applies to the use of animals for the following purposes:
- the development, manufacture and quality, effectiveness and safety testing of drugs, foodstuffs and other substances or products:
- in treating diseases or health problems in man, animals or plants;
- in treating physiological conditions in man, animals or plants;
- the protection of the natural environment in the interests of man or animal.
Each Member State must prohibit the use of endangered species for experimental purposes. The use of such animals may only be permitted in specific cases:
- if the aim of the experiment/research in question is the preservation of the species concerned;
- if this species seems to be the only one suitable for the biomedical purpose.
As far as the care and accommodation of animals is concerned, Member States must ensure that:
- all animals are provided with hygienic living conditions;
- any restriction on the animal's normal behaviour is limited to the absolute minimum;
- the physical conditions in which animals are kept are checked;
- the well-being of the animal is observed by a competent person to prevent any suffering;
- any unnecessary suffering is eliminated as soon as possible.
Each Member State must designate the authorities responsible for verifying that this Directive is implemented.
Where it is planned to subject an animal to an experiment in which it will, or may, experience pain which is likely to be prolonged, that experiment must be specifically declared and justified to, or specifically authorised by, the authority. The authority will take appropriate judicial or administrative action if it is not satisfied that the experiment is of sufficient importance for the essential needs of man or animal.
The authority in each Member State will collect and periodically make publicly available the following statistical information on the use of animals for experimental purposes:
- the number and kinds of animals used in experiments;
- the number of animals, by selected categories, used in experiments;
- the number of animals, by selected categories, used in experiments required by legislation.
Member States are invited to inform the Commission of the measures taken in the area of the protection of animals used for certain experimental purposes and to provide a suitable summary of statistical information.
Experiments must only take place if there is no alternative method that does not entail the use of animals. Animals involved must be those with the lowest degree of neuro-physiological sensitivity. (emphasis added)
Persons who carry out experiments or take part in them must be scientifically competent and have the appropriate education and training.
Breeding, supplier and user establishments must be approved by the competent authorities. Furthermore, these establishments must keep a record of all the details concerning the animals (the number and species of animals sold or supplied, the dates on which they are sold or supplied, the name and address of the recipient, etc.) for a minimum of three years.
User establishments must be designed in such a way as to allow optimum results to be obtained with the minimum degree of suffering for the animals.
Any animal taken to a breeding, supplier or user establishment must be provided with an identification mark in the least painful manner possible.
Animals used must be given a local or general anaesthetic. When an anaesthetic is not possible, analgesics may be given instead.
After an experiment, the animal must be given medical care aimed at its recovery. In the event that the well-being of the animal cannot be guaranteed, it must be killed by a humane method as soon as possible.
At the end of the experiment, the competent authority may decide to release the animal on the condition that this does not present a danger to public health or to the well-being of the animal.
In order to avoid any risk of duplication in experiments, Member States must accept to mutually recognise their scientific results.
The Member States and the Commission should encourage research in order to find other scientific methods that provide the same level of information without entailing the use or suffering of animals. (emphasis added)
Directive 2003/65/EC
The technical annexes to Directive 86/609/EEC which include guidelines for accommodation and care of animals must be updated as the scientific data on which they are based is out of date. To facilitate the revision of the annexes, in place of the codecision procedure hitherto in force, this Directive introduces the regulatory committee procedure, which is far simpler and faster.
REFERENCES
| Act | Entry into force - Date of expiry | Deadline for transposition in the Member States | Official Journal |
| Directive 86/609/EEC | 28.11.1986 | 4.11.1989 | OJ L 358 of 18.12.1986 |
| Amending act(s) | Entry into force | Deadline for transposition in the Member States | Official Journal |
| Directive 2003/65/EC | 16.9.2003 | 15.9.2004 | OJ L 230 of 16.9.2003 |
RELATED ACTS
Proposal for a Directive of the European Parliament and of the Council of 5 November 2008 on the protection of animals used for scientific purposes [COM (2008) 543 final – Not published in the Official Journal].
This Proposal adds to Directive 86/609/EEC regarding the protection of animals used for experimental and other scientific purposes by introducing new measures aiming to improve the protection and well-being of animals used for experiments. The Proposal will in particular encourage alternative methods rather than those involving live animals and provides a solid basis for the application of the principle of the Three Rs (Replacement, Reduction and Refinement) in animal experiments. The Proposal repeals Directive 86/609/EEC.
Codecision procedure (COD/2008/0211).
This recommendation updates the guidelines for the accommodation and care of animals used for experimental and other scientific purposes. It aims to take account, in particular, of decisions taken by the parties to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes, as approved by Council Decision 1999/575/EC.
Statistical reports
In accordance with Articles 13 and 26 of Directive 86/609/EEC, each Member State must provide the Commission with certain statistical information concerning the use of animals for experimental purposes and other scientific purposes.
This report presents the data from 2005, with the exception of France which gathered its data in 2004. It is the first such report to cover the ten Member States which joined the EU on 1 May 2004. The number of animals used in 2005 totalled 12.1 million, with 8.6% of the animals used in the EU coming from the countries which joined in 2004. Malta stated that no experiments on animals had been carried out on its territory. As in previous years, rodents and rabbits were the most commonly used species (78%), followed by fish.
Fourth Commission 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(2005) 7 final – not published in the Official Journal].
This report is based on data from 2002, with the exception of France which gathered its data in 2001. The report highlights that, for the first time, all Member States used standard statistical tables ("EU tables"). Moreover, the data collected now cover all procedures and their aims. The number of animals used in 2002 totalled 10.7 million, of which most were rodents and rabbits, but with a significant increase in the use of fish.
The report is based on the data for 1999. The difference compared with the previous reports is that the data forwarded by the Member States on this occasion cover a broader range of procedures and purposes. This enabled far more accurate and complete tables to be compiled at Union level.
The report notes a downward trend in the use of animals for experimental and other scientific purposes. In 1999, 9.8 million animals were used. As in previous years, rodents and rabbits were used most.
Second Commission report to the Council and to the European Parliament on statistics concerning the number of animals used for experimental purposes and for other scientific purposes in the Member States of the European Union [COM(1999) 191 final – not published in the Official Journal].
First Commission report to the Council and to the European Parliament on statistics concerning the number of animals used for experimental purposes or for other scientific purposes [COM(94) 195 final – not published in the Official Journal].
The first report concerns 1991. The data shown in the summary table for the whole of the European Union relate to 1990, 1991 and 1992. Belgium and Luxembourg did not provide data.
The European Convention for the protection of vertebrate animals used for experimental or other scientific purposes
Council Decision 1999/575/EC of 23 March 1998 on the conclusion of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes [Official Journal L 222 of 24.8.1999].
The Community supports any actions whose main objective is the well-being of animals used for experimental purposes. For this reason, the Community will intensify its efforts to develop substitute scientific methods in order to meet its objective of reducing the number of animals used for experimental purposes.
Council Decision 2003/584/EC of 22 July 2003 concerning the conclusion of the Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes [Official Journal L 198, 6.8.2003].
The Protocol sets out a simplified procedure for amending the technical appendices to the Convention to allow it to reflect the latest scientific and technical developments and research results within the fields covered.
