Protection of laboratory animals
The European Union (EU) wishes to put an end to experiments on animals by replacing such experiments with substitute methods. However, in the absence of the latter, the Commission is adopting measures aimed at improving the situation of animals which are still used for experiments, in accordance with the rule that tests on animals must be replaced, reduced and refined.
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.
Each year, some 12 million animals are used for scientific purposes. At present, the European Union (EU) is unable to ban the use of animals in safety tests and biomedical research. However, in order to protect laboratory animals and enable research to advance further, the EU is taking measures aimed at limiting animal testing and imposing minimal requirements concerning the housing of animals and the care they receive.
The scope of this Directive extends to animals used in basic research, education and training. It applies to all live non-human vertebrate animals and also to certain invertebrates which are likely to feel pain (cuttlefish, octopus, etc.).
The use of non-human primates is subject to restrictions and the use of great apes (chimpanzees, bonobos, gorillas and orangutans) is forbidden. Great apes may be used only in exceptional circumstances in order to ensure the survival of the species or in the case of an unexpected outbreak of a life-threatening or debilitating disease in human beings.
Fields subject to animal testing
Animal testing can be authorised only in procedures for which the purpose is:
- basic research;
- translational or applied research concerning:
- the avoidance, prevention, diagnosis or treatment of disease or abnormalities in human beings, animals or plants;
- the assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants;
- the welfare of animals and the improvement of stock breeding for agricultural purposes;
- the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs, etc. for any of the aims above;
- environmental protection and biodiversity;
- higher education or vocational training.
The use of animals for experimental purposes is authorised in cases where no satisfactory substitute method exists, in accordance with the rule that tests on animals must be replaced, reduced and refined. Projects involving experiments on animals are assessed by the competent authority. No project may begin until it has received a positive assessment from the competent authority. This assessment must demonstrate that the use of animals is justified and that the expected advantages outweigh the harm caused to the animals.
The number of animals used in a project must be reduced to a minimum without however compromising the objectives of the project. The living conditions and methods employed in the procedures must prevent as far as possible any pain, suffering or distress to the animals.
Animals used for experimental purposes must receive appropriate care and treatment. They must be housed in cages which are big enough for them and in an environment which is adapted to each species, in accordance with the standards listed in Annex III to the Directive.
The methods of killing must limit the pain, suffering and distress felt by the animals. Animals may be killed only by a person with the required skills in the establishment of the breeder, supplier or user, in accordance with the methods listed in Annex IV to the Directive.
The only authorised procedures are those which have been approved as part of a project. They are classified according to their degree of severity in accordance with Annex VIII to the Directive. They must be carried out under anaesthetia or using another method (analgesia, etc.) except if that is not appropriate or if anaesthetia is judged to be more traumatic to the animal than the procedure itself. As far as possible, the life of the animal must be spared. The procedures are designed to result in the death of as few animals as possible and to reduce the duration and intensity of suffering.
Reusing an animal is a way of reducing the total number of laboratory animals. Before reusing an animal, the severity of the cumulated procedures, the health of the animal and the opinion of the veterinarian must be taken into account.
At the end of a procedure, the veterinarian or a competent person shall decide if the animal can be kept alive. Animals kept alive shall receive appropriate care and accommodation as defined in Annex III.
Breeders, suppliers and users and their establishments must be authorised by a competent authority and registered with it.
Authorised establishments must have installations and equipment adapted to the species of animals housed and the performance of the procedures (where they are carried out).
Each animal introduced into an establishment must be provided with an identification mark and registered in the animal records (including information on the number, species, origin, date of sale, date of acquisition, etc.). These records are kept for five years and made available to the public.
Furthermore, each dog, cat and non-human primate must have an individual history file containing relevant reproductive, veterinary and social information on the individual animal and the projects in which it has been used.
The competent authorities carry out regular inspections of all breeders, suppliers and users and their establishments in order to ensure compliance with the requirements of this Directive.
The frequency of inspections is determined by the risks specific to each establishment. However, at least one third of the establishments of users are inspected each year and an appropriate proportion of the inspections shall be carried out without prior warning.
Breeders, suppliers and users of non-human primates are inspected at least once a year.
This Directive replaces Directive 86/609/EC from 1 January 2013.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
OJ L 276 of 20.10.2010