TITLE IIIREFERENCE LABORATORIES

Article 32Community 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 field38.

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 33National 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.