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Legislation for the protection of animals used for scientific purposes

Horizontal legislation on the protection of animals used for scientific purposes

Directive 2010/63/EU

Directive 2010/63/EU revising Directive 86/609/EEC on the protection of animals used for scientific purposes was adopted on 22 September 2010. 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.

Consolidated Commission Implementing Decision 2012/707/EU as corrected by Decision 2014/11/EU

This Decision sets out a common format for submitting information on the use of animals for scientific purposes as referred to in paragraphs 1, 2, and 3 of Article 54 of Directive 2010/63/EU. The new system will allow the Commission to assess effectiveness of the implementation of the legislation and help ensure consistency in its application. The first data under the new statistical reporting format will be collected from 1 January 2014. The Seventh Statistical Report will follow the format of all previous reports.

Recommendation 2007/526/EC

The Recommendation (adopted on 18 June 2007) introduces guidelines for the accommodation and care of animals used for experimental and other scientific purposes. This Recommendation compliments Annex III of Directive 2010/63/EU, which is based on provisions found therein, and sets down firm rules on requirements for accommodation and care of experimental animals. It also aligns EC legislation with the revised Council of Europe guidelines (Appendix A of Convention ETS 123), on accommodation and care of laboratory animals.

Other related legislation

Council Decision 1999/575/EC

This Decision makes the European Community party to the Council of Europe Convention ETS 123 on the protection of animals used for experimental and other scientific purposes. The contents of the Convention are practically identical to that of Directive 86/609/EEC.

Council Decision 2003/584/EC

Linked to the Council Decision 1999/575/EC (above), this Decision 'ratifies', on behalf of the Community, the possibility of updating the appendices of the Council of Europe Convention ETS 123 in a more simplified manner, known as a 'protocol of amendment'. The provisions contained in the Appendices to the Convention are of a technical nature and should reflect the latest scientific and technical developments and results in the research within the fields covered. Therefore a simplified procedure to revise these provisions is needed.

Repealed legislation

Directive 86/609/EEC

Directive 86/609/EEC is replaced by Directive 2010/63/EU on the protection of animals used for scientific purposes with effect from 1 January 2013 with the exception of Article 13, which shall be repealed with effect from 10 May 2013. The old Directive introduced for the first time legal provisions in the EU to harmonise national provisions covering the welfare of animals used for experimental and scientific purposes

Directive 2003/65/EC

This Directive amended 86/609/EEC by introducing the comitology procedure into the Directive. This allowed the Directive’s annexes to be updated more swiftly to be brought into line with the latest scientific and technical developments within the field.

Link to the archived pages on the Revision of Directive 86/609/EEC