No changes to EU Directive proposed in European Commission review
The European Commission has today (Friday 10 November 2017) published a report in response to Article 58 of Directive 2010/63/EU that requires a review of the Directive by today’s date. Two documents are available – a 145 page Staff Working Document (SWD), which is a comprehensive overview of stakeholder responses to the Commission’s consultation, and a shorter 10 page Report which summarises the detailed information in the SWD.
In 2010, the EU adopted Directive 2010/63/EU on the protection of animals used for scientific purposes, updating and replacing Directive 86/609/EEC. All uses of live animals for research, education, or testing must be carried out in compliance with this Directive.
The Directive’s three key objectives are to:
- Ensure efficient functioning of the EU internal market and enhance competitiveness and innovation of the EU research industry through the creation of a level playing field.
- Ensure high standards of welfare for animals used for scientific purposes.
- Improve transparency to the general public of the performance of research establishments in terms of animal use and welfare.
The review published today aims to assess how well the Directive's objectives are being achieved and whether it is fit for purpose or needs updating given the latest scientific and ethical developments. The review takes into account advances in the development of non-animal alternatives, in particular those replacing non-human primates. It also incorporates conclusions from a feasibility study on the progress towards using second and/or higher generation non-human primates, as required under Article 10.
UAR was pleased to see that its work on improving openness about animal research, and in particular the Concordat on Openness on Animal Research in the UK, is highlighted in the Staff Working Document as an example of progress towards meeting the Directive’s third key objective.
The main conclusions of the Report are that:
The majority of stakeholders consider the Directive to be relevant and necessary for creating a level playing field within the EU and achieving the animal welfare objectives and standards.
Therefore no amendments to the Directive are proposed at this stage.
However, harmonisation as an objective of the Directive is not yet considered to be reaching its potential. It is clear from the report that there are still significant differences in implementation across the Member States.
It is too early to carry out a full review of the implementation of the Directive.
The legally required completion date for this review comes quite early, and the report can only give preliminary indications of progress, problem areas, and good practice. A full evaluation of the Directive will be undertaken after 2019, once information on the practical implementation of the Directive by Member States; national statistical data for trends of animal use at EU level, and information on retrospective assessments of projects become available.
No phasing-out timetable for the use of non-human primates is proposed.
When it was published, the Directive stipulated that there should be an appropriate transition period, after which non-human primates could only be used for research if they were the offspring of animals bred in captivity (F2/F2+), or sourced from self-sustaining colonies. The aim of this requirement was to end the capture of non-human primates from the wild for both scientific and breeding purposes.
The current deadline in the Directive Annex II is set at November 2022, apart from for Marmosets which have been required to be F2/F2+ since January 2013. Article 10 requires a feasibility study to assess the appropriateness of Annex II deadlines, and to propose amendments, where appropriate.
The Article 10 feasibility study suggests that there is no justification to prolong the transitional period set out in Annex II 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.
Article 10 of Directive 2010/63/EU: .."For the purposes of this Article a ‘self-sustaining colony’ means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans."..
Standards for cephalopods will be incorporated 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 for cephalopods, and to align existing methods with the latest scientific knowledge on the basis of annual reports by Member States, where appropriate.
Last edited: 8 March 2022 10:31