X1TITLE IIIREFERENCE LABORATORIES

Annotations:
Editorial Information

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.

F15

Other Community reference laboratories relevant to the areas referred to in Article 1 may be included in Annex VII by the Commission. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 62(4). In accordance with the same procedure, Annex VII may be updated.

F16

Additional responsibilities and tasks for Community reference laboratories may be laid down by the Commission. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 62(4).

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 field36.

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.