WHAT IS THE AIM OF THE DIRECTIVE?
- Directive 2010/63/EU sets out measures designed to protect animals used for scientific purposes, including animals used in basic and applied research, particularly for producing medical products for humans and animals and for the safety and efficacy testing of products and substances.
- It also introduces protective measures for animals used for the purposes of higher education and vocational training.
- The directive represents an important step towards the final goal of the full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible.
- It replaces and repeals Directive 86/609/EEC.
KEY POINTS
To protect laboratory animals and enable research to advance further, these measures aim at limiting animal testing to an absolute minimum and setting up compulsory standards concerning the use, housing and care of the animals. High animal welfare standards benefit both the animals and science.
Scope
- The directive applies to all live, non-human vertebrate animals and also to certain invertebrates which are likely to feel pain (cuttlefish, octopuses, etc.).
- The use for testing of non-human primates is subject to restrictions, and the use of great apes (chimpanzees, bonobos, gorillas and orangutans) is forbidden.
Fields subject to animal testing
Animal testing is authorised only in procedures for which the purpose is:
- basic research;
- translational and applied research aimed at preventing, diagnosing or treating human or animal diseases;
- the development, manufacture or testing of the quality, effectiveness and safety of drugs, food and animal feed, chemicals, etc.;
- protecting the natural environment in the interests of human or animal health;
- research directed at species conservation;
- higher education or training;
- forensic investigation.
Evaluation of projects involving experimentation on animals
- The use of animals for experimental purposes is authorised in cases where no satisfactory substitute method exists.
- Projects involving experiments on live animals must be assessed by the competent authority. They may not begin until they have received a positive assessment demonstrating that the use of animals is justified and that the expected advantages outweigh the harm caused to the animal, taking into account ethical considerations.
- The number of animals used in a project must be reduced to a minimum, without compromising the objectives of the project.
- The living conditions and methods used in the procedures must minimise any unnecessary pain, suffering or distress to the animals.
Animal welfare
- Animals used for experimental purposes must receive appropriate care and treatment.
- Establishments should ensure the following.
- Animals are housed in cages which are big enough for them and in an environment which is adapted to their species, in accordance with the standards listed in Annex III to the directive.
- Social animals are housed together in cages, and enrichment techniques are used to increase the animals’ range of activities, particularly encouraging physical exercise, exploration and cognitive activities in line with their natural behaviour.
- An animal welfare body is set up to provide advice on animal-welfare issues and on new ways to replace, reduce and refine animal use (this is known as the three Rs principle). This body should include the person responsible for the welfare of the animals and be advised by a designated veterinarian. Their work is supported by national committees set up in each EU Member State for the protection of the animals used.
- 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 and in accordance with the methods listed in Annex IV to the directive.
- More generally, all individuals who interact with the animals should have the appropriate training and practice and should have their competence assessed before working without supervision.
Procedures
- The only authorised procedures are those which have been approved as part of an authorised project.
- Procedures are:
- classified according to their degree of severity, based on Annex VIII to the directive;
- to be carried out under anaesthesia or using another method, such as analgesia, except if it is not appropriate or if anaesthesia 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 deaths 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 actual 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 must decide if the animal can be kept alive. Animals kept alive must receive appropriate care and accommodation as defined in Annex III.
Authorisation
- Breeders, suppliers and users, and their establishments, must be authorised by a competent authority and must be registered with it.
- Authorised establishments must have installations and equipment adapted to the species of animals housed and, where procedures are carried out, to the performance of the procedures.
- They should have records in which they note all new knowledge on the animals, their origin and their purpose. These records are kept for 5 years and made available to the public.
- In addition, each dog, cat and non-human primate must have an individual identification and history file containing relevant reproductive, veterinary and social information, including the projects in which it has been used.
Inspections
- 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 a proportion of these are inspected without prior warning.
- Breeders, suppliers and users of non-human primates are inspected at least once a year.
Transparency
- Every year, Member States must collect and make publicly available statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures.
- In addition, Member States must publish non-technical project summaries (NTSs) of authorised projects within 6 months from the authorisation. NTSs must not breach the anonymity of the users.
- Member States may require these summaries to specify whether a project is to undergo a retrospective assessment and by what deadline. In such a case, they must ensure that the summary is updated with the results of the assessment.
- The European Commission has established two open-access databases containing Member States’ annual statistical data (the animal use reporting EU system statistical database) and NTSs (the animal use reporting EU system NTS database).
Reporting
- Member States must, by 10 November 2023, and every 5 years thereafter, send the information on the directive’s implementation to the Commission and submit and publish it in the format set out in Implementing Decision (EU) 2020/569. No more than 6 months later, the Commission must publish and regularly update an EU-wide overview on the basis of the data.
- Member States must collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures. They must submit these statistics to the Commission by 10 November of the following year at the latest and in a format set out by the Commission. The Commission will publish an annual summary report of the statistical data submitted by the Member States.
Amendments
Annexes III and IV have been amended by Delegated Directive (EU) 2024/1262. The amendments concern mainly zebra fish, passerine birds and cephalopods.
FROM WHEN DO THE RULES APPLY?
Directive 2010/63/EU had to be transposed into national law by 10 November 2012. These rules have applied since 1 January 2013.
Amending Delegated Directive (EU) 2024/1262 has to be transposed into national law by 4 December 2025. The rules apply from 4 December 2026.
BACKGROUND
For further information, see:
MAIN DOCUMENT
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 (OJ L 276, 20.10.2010, pp. 33–79).
Successive amendments to Directive 2010/63/EU have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Delegated Directive (EU) 2024/1262 of 13 March 2024 amending Directive 2010/63/EU of the European Parliament and of the Council as regards the requirements for establishments and for the care and accommodation of animals, and as regards the methods of killing animals (OJ L, 2024/1262, 15.5.2024).
Commission Implementing Decision (EU) 2020/569 of 16 April 2020 establishing a common format and information content for the submission of the information to be reported by Member States pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes and repealing Commission Implementing Decision 2012/707/EU (OJ L 129, 24.4.2020, pp. 16–50).
Commission Recommendation 2007/526/EC of 18 June 2007 on guidelines for the accommodation and care of animals used for experimental and other scientific purposes (OJ L 197, 30.7.2007, pp. 1–89).
