EU Directive 2010/63/EU on the protection of animals used for scientific purposes

See also this more general page on Legislation.

The text of Directive 2010/63/EU and many resources about its use are available at: ec.europa.eu/animals-in-science, including the consolidated version.
This website includes sections on:

• Legislation and implementation
• The Three Rs and alternative approaches
• Statistics on the use of animals in experiments in the EU, including the ALURES statistical database for detailed datamining
• Opinions of EU Expert Committees on the use of animals in experiments
• Related topics within animal science and welfare
• Posters and guidance documents (see below for links to the individual guidance documents)
• Questions and answers on the legal understanding of specific provisions of the Directive
• Links, among others to the networks established under the Directive
• National Contact Points (NCP) for each member state (Proceedings of the biannual NCP meetings from 2017)
• National contacts for the PARERE network
• National Committees for each member state
• Voluntary progress reports from member states

The Directive 2010/63, which Norway has transposed, is part of efforts to achieve 'the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so'. To that end, it 'seeks to facilitate and promote the advancement of alternative approaches. It also seeks to ensure a high level of protection for animals that still need to be used in procedures' (Recital 10).

There is a glossary of terms in the Commission's summary report on the statistics of animal use (2020 version, section III.4).
More information about the numbers of animals used in education, research and testing in the EU and Norway is available here.

When do fish larvae become old enough to be protected by the legislation? According to the EU Directive, this is when the fish becomes an 'independently feeding larval form'. The time for this has not been defined more exactly in EU or Norwegian legislation or guidance. However, in the case of zebrafish, it is common to set day 5 post fertilisation ("dpf 5"), i.e. an age of 120 hours, as the boundary, based on scientific studies of fish development.  See also the pages on legislation for fish research.

Norway implemented most of the Directive through national legislation on 1 July 2015, and then via the European Economic Area Agreement (EØS-avtalen) on 1 August 2016 (see the Norwegian-language version of this page). The Three Rs are implicitly mentioned in the Directive as an obligation for all those involved in the use of animals for scientific purposes.

FELASA categories A-D and EU categories a-d

The EU Directive includes a new definition of the categories of personnel who are involved in animal research. The functions are:

• a: those carrying out procedures on animals
• b: those designing procedures and projects
• c: those taking care of animals
• d: those killing animals

These functions must not be confused with the old FELASA categories A-D, which were very different.

The Directive includes the following Annexes

• Annex I: ​List of animals referred to in Article 10 (animals bred for use in procedures)
• Annex II:​ List of non-human primates and dates referred to in the second subparagraph of Article 10(1) 
• Annex III: Requirements for establishments and for the care and accommodation of animals*
• Annex IV: Methods of killing animals*
• Annex V: List of elements referred to in Article 23(3) (requirements for education, training and competence)
• Annex VI: Lists of elements referred to in Article 37(1)(c) (Non-Technical Project Summaries)
• Annex VII: Duties and tasks of the Union Reference Laboratory
• Annex VIII: Severity classification of procedures

*A revision of the requirements for zebrafish in Annexes III & IV, and for passerine birds in Annex III, was published in October 2023 and came into force on 4 June 2024.

Guidance documents
The Member States have endorsed the following:

• EU guidance document on animal welfare bodies and national committees
• EU guidance document on non-technical project summaries
• EU guidance document on inspections and enforcement
• EU guidance document on genetically altered animals
• EU guidance document on project evaluation and retrospective assessment
• EU guidance document on severity assessment framework
• EU guidance document on education and training framework 

A description of the EU protection of farm animals (which are often used in research), and the concept of The Five Freedoms, is available here.

The Commission has written (link no longer available):

'The aim of the new Directive is to strengthen legislation, and improve the welfare of those animals still needed to be used, as well as to firmly anchor the principle of the Three Rs, to Replace, Reduce and Refine the use of animals, in EU legislation.

The Directive is firmly based on the principle of the Three Rs, to replace, reduce and refine the use of animals used for scientific purposes.

The scope is now wider and includes foetuses of mammalian species in their last trimester of development and cephalopods, as well as animals used for the purposes of basic research, higher education and training.

It lays down minimum standards for housing and care, regulates the use of animals through a systematic project evaluation requiring inter alia assessment of pain, suffering distress and lasting harm caused to the animals.

It requires regular risk-based inspections and improves transparency through measures such as publication of non-technical project summaries and retrospective assessment.

The development, validation and implementation of alternative methods is promoted through measures such as establishment of a Union reference laboratory for the validation of alternative methods supported by laboratories within Member States and requiring Member States to promote alternative methods at national level.'

Documents of relevance to the implementation of the Directive 

The EU has had specific legislation covering the use of animals for scientific purposes since 1986. On 22 September 2010 the EU adopted Directive 2010/63/EU which updates and replaces the 1986 Directive 86/609/EEC on the protection of animals used for scientific purposes (a comparison of 86/609/EEC and 2010/63/EU). The Directive took full effect in the EU on 1 January 2013.

When the Lisbon Treaty came into force in 2009, it introduced the recognition that animals are sentient beings, by amending the Treaty on the Functioning of the European Union (TFEU).

Directive 2010/63 was amended in 2019 by Regulation (EU) 2019/1010 (see Article 6 of the Regulation, which amends Articles 43 and 54 of the Directive, and deletes Article 57) to incorporate ambitious goals for reporting and transparency to help progress towards the ultimate goal of total replacement of animal use: Member States shall 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.

Article 58 of the Directive required the Commission to review it by 10 November 2017. This process is described here and the Report is available here.

Commission Implementing Decision 2020/569/EU (16 April 2020) established a common format and information content for submissions from Member States in compliance with the Annexes in the Directive. This includes a template for the Non-Technical Project Summaries referred to in Article 43(1) and their updates, and the submission of statistical data. This Decision repealed an earlier Decision (2012/707/EU).

The journal Laboratory Animals has published ESLAV/ECLAM/LAVA/EVERI recommendations for the roles, responsibilities and training of the laboratory animal veterinarian and the designated veterinarian under Directive 2010/63/EU. These provide professional guidance on the role and postgraduate training of laboratory animal veterinarians, who may be working as designates veterinarians under the Directive.

European Citizens Initiatives (ECI)

An ECI entitled Stop Vivisection to abrogate the Directive resulted in a public meeting, entitled Non-Animal Approaches - the Way Forward, for the stakeholders which was held in Brussels on 6-7 December 2016 (Conference Report). The Commission's response to the Initiative can be read here.

Another ECI, Save Cruelty Free Cosmetics, was registered in 2021 and validated in January 2023 (see the Eurogroup for animals website). It also includes petitions to commit to changes in the EU chemicals legislation and a legislative proposal plotting a roadmap to phase-out all animal testing in the EU before the end of the current legislative term.

Links to other relevant EU websites

• European Chemicals Agency (ECHA)
• European Medicines Agency (EMA)
• European Food Safety Authority (EFSA)
• Cosmetics regulation
• REACH regulation (see also ECHA)
• Pesticides
• Biocides
• Pharmaceutical strategy for Europe