Directive 2010/63/EU as amended by Regulation (EU) 2019/1010
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.
Regulation (EU) 2019/1010 on the alignment of reporting obligations in the field of legislation related to the environment, adopted on 5 June 2019, amends in its Article 6 Directive 2010/63/EU to improve transparency and reporting obligations. It amends Articles 43 and 54 of the Directive by foreseeing a central, open access EU database for the publication of Non-technical Project Summaries, and for some Member States, the publication of the results of Retrospective Assessment of projects. Furthermore, it provides a central, open access EU database for the publication of annual statistics.
This Decision sets out a common format for submitting information to the Commission as provided in Articles 43 and 54 of Directive 2010/63/EU. Article 43 requires the submission of non-technical project summaries of projects authorised from 1.1.2021 onward to an open access EU database. Some Member States require these to be updated by the results of retrospective assessment as provided in Article 39 of the Directive. Article 54 requires Member States to report on the implementation of the Directive, submit annual statistical data on the use of animals for scientific purposes and report on exemptions granted to Annex IV killing methods under Article 6(4)(a). The next Member State implementation reports are due in November 2023. The first data sets under the revised statistical reporting requirements will cover the year 2021 and submitted to the Commission by 11 November 2022 for publication by the Commission in 2023.
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.
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.
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.
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
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.