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Implementation, interpretation and terminology of Directive 2010/63/EU

The following documents are intended as guidance to assist Member States and others affected by this Directive to arrive at a common understanding of the provisions contained in the Directive. All comments should be considered only within the context of Directive 2010/63/EU on the protection of animals used for scientific purposes.

Only the Court of Justice of the European Union is entitled to interpret EU law with legally binding authority.

Questions & Answers on the legal understanding

The Commission has been asked a number of questions concerning the legal understanding of specific provisions of the Directive. For the benefit of all those affected by the Directive, these questions are collated in the following

Q&A Document

Consensus documents

The National Contact Points (NCP) of the Member States responsible for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes and the Commission agreed to discuss a number of articles contained in the Directive with a view to finding a common approach throughout the EU.

The NCP and the Commission referred some elements of the Directive to specific Expert Working Group (EWG) meetings. The outcome of the EWG meetings, reflecting the collective and invaluable input from Member States' and main stakeholder organisations' experts, was submitted to the NCP for endorsement.

The consensus on the understanding of the elements discussed at the NCP meetings are presented below to promote uniform implementation and application of the Directive. It is important to note that some of these documents may present "work in progress" (indicated as such). However, it was felt important to inform all those affected by the Directive as soon as progress is made.

 

SUBJECT MATTER

Related Articles

CONTENTS OF THE DOCUMENT

Document status

Animal Welfare Bodes and National Committees

pdf

26
27
49

Guidance and principles of good practise on the design and functioning of Animal Welfare Bodies and National Committees for the protection of animals used for scientific purposes

- endorsed by NCP
on 9-10.10.2014

Education and training

pdf

23
24
25
(34)
(38)

Education and training framework with a modular Learning Outcome-based training structure, principles and criteria for supervision, competence assessment, continued professional development and for a mutual approval/accreditation of courses

- updates endorsed
on 23-24.1. and 18-19.9.2013 and on 19-20.2.2014

- endorsed by NCP
on 22-23.3.2012

Genetically altered animals

pdf

 

1(2)
3(1)
4(3)
17(1)

The principles of creation, establishment and maintenance of genetically altered animal lines and how these are considered within project authorisation and statistical reporting

- corrigendum endorsed
on 23-24.1.2013

- update endorsed
on 11-12.7.2012

- endorsed by NCP
on 22-23.3.2012

Inspections and enforcement

pdf

34
60

Guidance and principles of good practise on the planning and execution of an effective inspection and enforcement programme

- endorsed by NCP
on 9-10.10.2014

Non-technical project summaries

pdf

43

Guidance on the drafting and publication of non-technical project summaries including a template and an illustrative example - endorsed by NCP on 23-24.1.2013

Project Evaluation/
Retrospective Assessment

pdf

37
38
39

Guidance for performance of Project Evaluation including harm-benefit assessment and Retrospective Assessment of projects - endorsed by NCP on 18-19.9.2013

Severity assessment

pdf

4(3)
15(1)
16(1)(d)
54(2)

The severity assessment framework from project planning, monitoring and assessing the severity through to final assignment of actual severity

- endorsed by NCP
on 11-12.7.2012

Severity assessment – illustrative examples

pdf

idem as above

Illustrative examples of practical application of the severity assessment process

- endorsed by NCP
on 23-24.1.2013

Various articles in the Directive

pdf

1(5)
3
16
40
41

Practices that are exempted from the scope; understanding of definitions for a procedure and project; use, re-use and continued use; multiple generic projects and complex or multi-disciplinary projects

- endorsed by NCP
on 6-7.10. 2011