aiming for better science

1 ANIMAL welfare BODIES AND NATIONAL COMMITTEESDIRECTIVE 2010/63/EUON PROTECTION OF ANIMALS USED FOR SCIENTIFIC PURPOSESC aring for animals aiming for better science Novo NordiskEnvironment 1 National Competent Authorities for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes A working document on Animal welfare Bodies and National Committees to fulfil the requirements under the Directive Brussels, 9-10 October 2014 The Commission established an Expert Working Group (EWG) to prepare guidance on Animal welfare Bodies and National Committees to fulfil the requirements under Articles 26, 27 and 49 of Directive 2010/63/EU on the protection of animals used for scientific purposes. All Members States and main stakeholder organisations were invited to nominate experts to participate in the work.

2 The EWG met on 11-12 June 2014. The objectives of the EWG were to develop guidance and principles of good practice with respect to the requirements of the Directive for Animal welfare Bodies and National Committees to facilitate the implementation of the Directive. This document is the result of the work of the EWG meetings, discussions with the Member States as well as legal input from the Commission. It was endorsed by the National Competent Authorities for the implementation of Directive 2010/63/EU at their meeting of 9-10 October 2014. Disclaimer: The following is intended as guidance to assist the Member States and others affected by Directive 2010/63/EU on the protection of animals used for scientific purposes to arrive at a common understanding of the provisions contained in the Directive and to facilitate its implementation.

3 All comments should be considered within the context of this Directive 2010/63/EU. It provides some suggestions on how the requirements of the Directive may be met. The content of the document does not impose additional obligations beyond those laid out in the Directive. Only the Court of Justice of the European Union is entitled to interpret EU law with legally binding authority. 2 The table of contents Introduction .. 3 The related articles of Directive 2010/63/EU .. 4 Animal welfare Bodies .. 5 Benefits of an effective Animal welfare Body .. 5 Structure, composition and competencies required of Animal welfare Bodies .. 6 Meeting the Animal welfare Body requirements in small breeders, users and suppliers .. 9 Delivering the tasks of the Animal welfare Body .. 10 Fostering a Culture of Care.

4 16 Achieving an effective Animal welfare Body .. 18 National Committees .. 22 Benefits of an effective National Committee .. 22 Composition and structures of the National 23 What do Animal welfare Bodies expect of a National Committee? .. 23 Delivering the tasks of a National Committee .. 24 Ensuring an effective National 27 Facilitating information exchange at EU level .. 27 3 Introduction The objective of this document is to provide information to all those involved in the oversight of and in the care and use of animals used in scientific procedures on how the requirements of the Directive with regard to the structure and function of the Animal welfare Body (AWB) (Articles 26 and 27) and the National Committee (Article 49) may be met. The Directive states that animal welfare considerations should be given the highest priority in the context of animal keeping, breeding and use.

5 One of the mechanisms of the Directive to achieve this aim is the creation of an AWB in each establishment (with potential exemption for small establishments which may fulfil the tasks of an AWB in other ways). AWBs provide internal oversight and guidance on the day-to-day application of the Three Rs, monitors the work in progress and reviews the outcomes of the work, and may have a positive role in the preparation of a project proposal. It is important for public confidence and to ensure a level playing field for all those involved in matters related to the acquisition, breeding, accommodation, care and use of animals within each Member State, that there is a coherent approach to project evaluation and the application of the Three Rs. Member States should have the necessary structures and tools to deliver these objectives, utilising the National Committee as appropriate.

6 Both the AWBs and the National Committees play a fundamental role in establishing and maintaining an appropriate climate of care, often called in practice, and subsequently referred to in this document as, a "culture of care", among the animal user community. Although the AWB may have input to the project application process, the evaluation of projects is an entirely separate requirement under the Directive. Guidance on Project Evaluation and Retrospective Assessment was developed by an earlier EWG and this was endorsed by the National Competent Authorities for the implementation of Directive 2010/63/EU at their meeting of September 20131. This guidance document is not intended to replicate or reproduce information contained in the Project Evaluation and Retrospective Assessment Guidance document.

7 1 4 The related articles of Directive 2010/63/EU Animal welfare Body Recital 31 "Animal- welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Breeders, suppliers and users should therefore have an animal- welfare body in place with the primary task of focusing on giving advice on animal- welfare issues. The body should also follow the development and outcome of projects at establishment level, foster a climate of care and provide tools for the practical application and timely implementation of recent technical and scientific developments in relation to the principles of replacement, reduction and refinement, in order to enhance the life-time experience of the animals.

8 The advice given by the animal- welfare body should be properly documented and open to scrutiny during inspections." Article 26 Animal- welfare body "1. Member States shall ensure that each breeder, supplier and user sets up an animal- welfare body. 2. The animal- welfare body shall include at least the person or persons responsible for the welfare and care of the animals and, in the case of a user, a scientific member. The animal- welfare body shall also receive input from the designated veterinarian or the expert referred to in Article 25. 3. Member States may allow small breeders, suppliers and users to fulfil the tasks laid down in Article 27(1) by other means." Article 27 - Tasks of the animal- welfare body "1. The animal- welfare body shall, as a minimum, carry out the following tasks: (a) advise the staff dealing with animals on matters related to the welfare of animals, in relation to their acquisition, accommodation, care and use; (b) advise the staff on the application of the requirement of replacement, reduction and refinement, and keep it informed of technical and scientific developments concerning the application of that requirement; (c) establish and review internal operational processes as regards monitoring, reporting and follow-up in relation to the welfare of animals housed or used in the establishment.

9 (d) follow the development and outcome of projects, taking into account the effect on the animals used, and identify and advise as regards elements that further contribute to replacement, reduction and refinement; and (e) advise on rehoming schemes, including the appropriate socialisation of the animals to be rehomed. 5 2. Member States shall ensure that the records of any advice given by the animal- welfare body and decisions taken regarding that advice are kept for at least 3 years. The records shall be made available to the competent authority upon request." National Committees Recital 48 "There is a need to ensure a coherent approach to project evaluation and review strategies at national level. Member States should establish national committees for the protection of animals used for scientific purposes to give advice to the competent authorities and animal- welfare bodies in order to promote the principles of replacement, reduction and refinement.

10 A network of national committees should play a role in the exchange of best practice at the level of the Union." Article 49 - National committees for the protection of animals used for scientific purposes "1. Each Member State shall establish a national committee for the protection of animals used for scientific purposes. It shall advise the competent authorities and animal- welfare bodies on matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practice. 2. The national committees referred to in paragraph 1 shall exchange information on the operation of animal- welfare bodies and project evaluation and share best practice within the Union." Animal welfare Bodies Benefits of an effective Animal welfare Body An effective AWB has many benefits for both animals and science and for the staff working with animals.