EU on the protection of animals used for scientific purposes - Main contents

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier	COM(2017)631 - Report in accordance with Article 58 of Directive 2010/63/EU on the protection of animals used for scientific purposes.
document	COM(2017)631
date	November 8, 2017

Annex II is set at November 2022, apart from 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 key findings and conclusions of the feasibility study are presented below.

The majority of the species used within EU are already available as F2/F2+.

The main species of concern is the Cynomolgus macaque whose global supply of F2/F2+ animals already now comfortably exceeds the current and projected EU demand. However, the additional five years (2017-2022) are needed to complete the transition, including Herpes B-virus-free animals from suppliers in Mauritius who are not yet able to fulfil the scientific demand with F2/F2+ animals.

Considering the current and projected EU demand of the relevant species and their supply from EU and non-EU countries, the impacts of the transition on science, animal welfare and health, the feasibility study does not support altering the dates set out in Annex II of the Directive.

However, to facilitate accurate reporting that allows measuring the progress towards the Directive goals, Commission Implementing Decision 2012/707/EU should be adjusted to obtain annual information on the generation of non-human primates supplied also from self-sustaining colonies.

5. Conclusions

The timing of this review in the early stages of the Directive's implementation makes it premature to assess many aspects of its performance against policy objectives. However, it is clear that the majority of stakeholders consulted for this review 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. Furthermore, and drawing from the conclusions of the SCHEER ⁸ report ⁹ , no phasing-out timetable for the use of non-human primates is proposed, however, the European Commission will request regular updates to the SCHEER opinion to closely monitor progress.

On the basis of the Article 10 feasibility study, 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.

Finally, 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.

(1)

SWD(2017) 353

(2)

http://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/project_evaluation/en.pdf

(3)

http://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/education_training/en.pdf

(4)

http://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/education_training/en.pdf

(5)

http://ec.europa.eu/environment/chemicals/lab_animals/3r/advance_en.htm

(6)

Annex II to Staff Working Document SWD(2017) 353

(7)

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."..

(8)

Scientific Committee on Health, Environment and Emerging Risks

(9)

https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_o_004.pdf