This Commission report responds to the provisions of Article 58 of Directive 2010/63 / EU on the protection of animals used for scientific purposes which requires a review of the Directive by 10 November 2017 at the latest. The purpose of the review is to determine whether the objectives of the Directive are achieved fulfilled, whether it is fit for its purpose or needs updating given the latest scientific and ethical developments.
Although it is still too early to assess many aspects of its performance against the policy objectives, the Directives framework is generally considered to be a sound basis for the regulation of animals used for scientific purposes. Therefore, no changes to the Directive are proposed at this stage.
Positive effects and problems noted: early indications are that the implementation of the Directive will deliver some of the changes and expected results. For example, stakeholders consider that the creation of animal welfare bodies is an effective requirement as it already contributes positively to the improvement of use practices.
Other positive effects were reported, including: (i) raised standards in care, accommodation and research practices; (ii) increased awareness of the three Rs (replacing and reducing the use of animals for scientific purposes and refining the care provided to them); (iii) the promotion of the culture of care; (iv) the growing recognition in the research community of the link between animal welfare and good science; and (v) greater transparency.
Areas identified by stakeholders as needing further attention and progress include the efficiency and consistency of project evaluation and authorisation processes as well as access to, and quality and transparency of information on the use of animals.
In addition, four key issues hindering a more rapid uptake of alternatives were identified: lack of knowledge; insufficient communication/spreading of information; acceptability, and cost.
Use of non-human primates: with the aim of ending capture of non-human primates from the wild for both scientific and breeding purposes, the Directive allows, after an appropriate transition period, the use only of non-human primates that are the offspring of animals which have been bred in captivity or that are sourced from self-sustaining colonies.
On the basis of the Article 10 feasibility study, there is no justification to prolong the transitional period set out in Annex II (November 2022) for the use of second and/or higher generation purpose-bred non-human primates. However, the reporting categories in Commission Implementing Decision 2012/707/EU will be amended to require inter alia systematic reporting of the generation of non-human primates used, including when acquired from self-sustaining colonies.
Lastly, once sufficient scientific evidence is available, Annex III on care and accommodation will need to be amended to incorporate standards for cephalopods and to provide more details for some groups of species.
Annex IV should be amended to provide appropriate killing methods in for cephalopods, and to align existing methods with latest the scientific knowledge on the basis of annual reports by Member States, where appropriate
Factual information on practical implementation of the Directive by Member States is not due until 2018. National statistical data were published for the first time in 2015, but trends of animal use at EU level will not be known before 2019. Information on retrospective assessments of projects will become available from 2019.
Therefore, a full REFIT evaluation of the Directive will be undertaken after 2019 when better information is available.