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Summaries of EU Legislation

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Protection of laboratory animals

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Protection of laboratory animals

The European Union (EU)'s ultimate objective is 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.


In order to protect laboratory animals and enable research to advance further, the EU is taking measures aimed at limiting animal testing and imposing compulsory standards concerning the housing of animals and the care they receive.


The main objective of the Directive is to set out measures designed to protect animals used for scientific purposes, especially basic or applied research, particularly for the production of medical products, It also aims to establish protective measures for animals used for educational purposes.

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 orang-utans) is forbidden.

Fields subject to animal testing

Animal testing can be authorised only in procedures for which the purpose is:

  • basic research;
  • translational and applied research aimed at the prevention, prophylaxis, diagnosis or treatment of human or animal diseases;:
  • the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs, etc. for any of the aims above;
  • protection of the natural environment in the interests of human or animal health;
  • research directed at species conservation;
  • higher education or training;
  • forensic investigations.

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 animals are 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 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 minimise any unnecessary pain, suffering or distress to the animals.

Animal welfare

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. It is preferable to house animals in groups and for enrichment techniques to be used in order to increase the range of activities possible for the animal, particularly encouraging physical exercise, manoeuvring, exploration and cognitive activities.

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. Generally, all individuals who interact with the animals should have the appropriate training and practice while being observed by a supervisor who can attest to their skills.


The only authorised procedures are those which have been approved as part of an approved project. They are classified according to their degree of severity, based on Annex VIII to the Directive. They must be carried out under anaesthesia or using another method (analgesia, etc.) except if that 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 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).

They should possess records in which they register all developments in information on the animals, their origin and purpose. 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 identification and 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, which replaces directive 86/609/EEC from 1 January 2013, is registered in the context of an EU policy which is aimed at limiting experimentation on animals as far as possible and eliminating it completely if it is not strictly necessary. Experimentation on animals for the production of cosmetic products, which is not covered by this Directive, has therefore been completely forbidden since 2009 (Regulation (EC) No 1223/2009).



Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2010/63/EU



OJ L 276 of 20.10.2010


Commission Recommendation of 18 June 2007 on guidelines for the accommodation and care of animals used for experimental and other scientific purposes (2007/526/EC) [Official Journal L 197 of 30.07.2007].

2012/707/EU: Commission Implementing Decision of 14 November 2012 establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes [Official Journal L 320 of 17.11.2012].

2014/11/EU: Commission Implementing Decision of 20 December 2013 correcting Annex II to Implementing Decision 2012/707/EU establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes [Official Journal L 10 of 15.1.2014].

Last updated: 05.06.2014