Protection of animals used for experimental purposes
The European Union has established a framework to protect animals used for experimental or scientific purposes by ensuring that they are adequately cared for and that no unnecessary pain or suffering is inflicted.
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].
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.
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.
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.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
OJ L 358 of 18.12.1986
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
OJ L 230 of 16.9.2003