Regulation (EC) No 882/2004 of the European Parliament and of the Council (repealed)Dangos y teitl llawn

TITLE III REFERENCE LABORATORIES

Article 32 Community reference laboratories

1. The Community reference laboratories for feed and food referred to in Annex VII shall be responsible for:

(a) providing national reference laboratories with details of analytical methods, including reference methods;

(b) coordinating application by the national reference laboratories of the methods referred to in (a), in particular by organising comparative testing and by ensuring an appropriate follow-up of such comparative testing in accordance with internationally accepted protocols, when available;

(c) coordinating, within their area of competence, practical arrangements needed to apply new analytical methods and informing national reference laboratories of advances in this field;

(d) conducting initial and further training courses for the benefit of staff from national reference laboratories and of experts from developing countries;

(e) providing scientific and technical assistance to the Commission, especially in cases where Member States contest the results of analyses;

(f) collaborating with laboratories responsible for analysing feed and food in third countries.

2. The Community reference laboratories in the animal health sector shall be responsible for:

(a) coordinating the methods employed in the Member States for diagnosing diseases;

(b) assisting actively in the diagnosis of disease outbreaks in Member States by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies;

(c) facilitating the initial or further training of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community;

(d) collaborating, as regards methods of diagnosing animal diseases falling within their competence, with the competent laboratories in third countries where those diseases are prevalent:

(e) conducting initial and further training courses for the benefit of staff from national reference laboratories and of experts from developing countries;

3. Article 12(2) and (3) shall apply to Community reference laboratories.

4. Community reference laboratories shall fulfil the following requirements. They must:

(a) have suitably qualified staff with adequate training in diagnostic and analytical techniques applied in their area of competence;

(b) possess the equipment and products needed to carry out the tasks assigned to them;

(c) have an appropriate administrative infrastructure;

(d) ensure that their staff respect the confidential nature of certain subjects, results or communications;

(e) have sufficient knowledge of international standards and practices;

(f) have available, if appropriate, an updated list of available reference substances and reagents and an updated list of manufacturers and suppliers of such substances and reagents;

(g) take account of research activities at national and Community level;

(h) have trained personnel available for emergency situations occurring within the Community.

5. Other Community reference laboratories relevant to the areas referred to in Article 1 may be included in Annex VII in accordance with the procedure referred to in Article 62(3). In accordance with the same procedure, Annex VII may be updated.

6. Additional responsibilities and tasks for Community reference laboratories may be laid down in accordance with the procedure referred to in Article 62(3).

7. Community reference laboratories may be granted a Community financial contribution in accordance with Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(1).

8. Community reference laboratories may be subject to Community controls to verify compliance with the requirements of this Regulation. If these controls find that a laboratory is not complying with those requirements or tasks for which they have been designated, necessary measures may be taken in accordance with the procedure referred to in Article 62(3).

9. Paragraphs 1 to 7 shall apply without prejudice to more specific rules, and in particular Chapter VI of Regulation (EC) No 999/2001 and Article 14 of Directive 96/23/EC.

Article 33 National reference laboratories

1. Member States shall arrange for the designation of one or more national reference laboratories for each Community reference laboratory referred to in Article 32. A Member State may designate a laboratory situated in another Member State or European Free Trade Association (EFTA) Member and a single laboratory may be the national reference laboratory for more than one Member State.

2. These national reference laboratories shall:

(a) collaborate with the Community reference laboratory in their area of competence;

(b) coordinate, for their area of competence, the activities of official laboratories responsible for the analysis of samples in accordance with Article 11;

(c) where appropriate, organise comparative tests between the official national laboratories and ensure an appropriate follow-up of such comparative testing;

(d) ensure the dissemination to the competent authority and official national laboratories of information that the Community reference laboratory supplies;

(e) provide scientific and technical assistance to the competent authority for the implementation of coordinated control plans adopted in accordance with Article 53;

(f) be responsible for carrying out other specific duties provided for in accordance with the procedure referred to in Article 62(3), without prejudice to existing additional national duties.

3. Article 12(2) and (3) shall apply to national reference laboratories.

4. Member States shall communicate the name and address of each national reference laboratory to the Commission, the relevant Community reference laboratory and other Member States.

5. Member States that have more than one national reference laboratory for a Community reference laboratory must ensure that these laboratories work closely together, so as to ensure efficient coordination between them, with other national laboratories and with the Community reference laboratory.

6. Additional responsibilities and tasks for national reference laboratories may be laid down in accordance with the procedure referred to in Article 62(3).

7. Paragraphs 1 to 5 shall apply without prejudice to more specific rules and in particular Chapter VI of Regulation (EC) No 999/2001 and Article 14 of Directive 96/23/EC.

(1)

OJ L 224, 18.8.1990, p. 19. Decision as last amended by Regulation (EC) No 806/2003.