Directive 2010/63 - Protection of animals used for scientific purposes - Main contents

Summary of Legislation
Legislative text

1. Summary of Legislation

Protection of laboratory animals

SUMMARY OF:

Directive 2010/63/EU on protecting animals used for scientific purposes

WHAT IS THE AIM OF THE DIRECTIVE?

It sets out measures designed to protect animals used for scientific purposes, especially basic or applied research, particularly for the production of medical products.

It also introduces protective measures for animals used for educational purposes.

It replaces and repeals Directive 86/609/EEC.

KEY POINTS

In order 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 their use, housing and care. 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, octopus, etc.).The use for testing 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 testingAnimal testing is authorised only in procedures for which the purpose is:

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basic research;
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translational and applied research aimed at the prevention, diagnosis or treatment of human or animal diseases;
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the development, manufacture or testing of the quality, effectiveness and safety of drugs, food and animal feed, chemicals, etc. for any of the aims above;
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protecting the natural environment in the interests of human or animal health;
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research directed at species conservation;
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higher education or training;
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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 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 however 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:

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receive appropriate care and treatment;
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be housed in cages big enough for them and in an environment adapted to each species, in accordance with the standards listed in the directive’s Annex III.

Establishments should ensure:

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animals are 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;
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social animals should be housed in cages and‘enrichment’ techniques are used to increase the range of activities possible for the animal, particularly encouraging physical exercise, exploration and cognitive activities in line with their natural behaviour;
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they set up an animal welfare body to provide advice on animal-welfare issues and on new ways to ‘replace, reduce and refine’ the animal use (known as the ‘Three Rs’ principle). This body should include the person responsible for the welfare of animals and be advised by a designated veterinarian. Their work is supported by national committees set up in each EU country for the protection of 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, in accordance with the methods listed in the directive’s Annex IV.

More generally, all individuals who interact with the animals should have the appropriate training and practice and should have had their competence assessed before working without supervision.

ProceduresThe only authorised procedures are those which have been approved as part of an authorised project.

Procedures are:

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classified according to their degree of severity, based on the directive’s Annex VIII;
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to 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 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 the performance of the procedures (where they are carried out).They should have records in which they register all developments in information on the animals, their origin and purpose. These records are kept for 5 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.

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 without prior warning.Breeders, suppliers and users of non-human primates are inspected at least once a year.

Transparency

To ensure a better understanding of where and how animals are used, every year, EU countries 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. This may be in the form of non-technical summaries of authorised projects which do not breach the anonymity of the users.

FROM WHEN DOES THE DIRECTIVE APPLY?

It entered into force on 9 November 2010 and had to apply in the EU countries from 1 January 2013.

BACKGROUND

The EU's ultimate objective is to put an end to experiments on animals by replacing such experiments with a substitute, non-animal, approaches. However, given current scientific knowledge, it is not yet feasible to replace all animal experiments. For this reason, the legislation seeks to ensure that the situation of animals which are still used for experiments is improved and in accordance with the rule that tests on animals must be replaced, reduced and refined wherever possible.

For more information, see:

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Animals in scientific research (European Commission).

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)

2. Legislative text

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 Text with EEA relevance

Contents

1.

Summary of Legislation

2.

Legislative text