CHAPTER VAVOIDANCE OF DUPLICATION AND ALTERNATIVE APPROACHES

Article 46Avoidance of duplication of procedures

Each Member State shall accept data from other Member States that are generated by procedures recognised by the legislation of the Union, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment.

Article 47Alternative approaches

1

The Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field.

2

Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies.

3

After consulting the Member States, the Commission shall set the priorities for those validation studies and allocate the tasks between the laboratories for carrying out those studies.

4

Member States shall, at national level, ensure the promotion of alternative approaches and the dissemination of information thereon.

5

Member States shall nominate a single point of contact to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation.

6

The Commission shall take appropriate action with a view to obtaining international acceptance of alternative approaches validated in the Union.

Article 48Union Reference Laboratory

1

The Union Reference Laboratory and its duties and tasks shall be those referred to in Annex VII.

2

The Union Reference Laboratory may collect charges for the services it provides that do not directly contribute to the further advancement of replacement, reduction and refinement.

3

Detailed rules necessary for the implementation of paragraph 2 of this Article and Annex VII may be adopted in accordance with the regulatory procedure referred to in Article 56(3).

Article 49National 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.