Regulation (EC) No 2160/2003 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER VI U.K. LABORATORIES

Article 11 U.K. Reference laboratories

1. Community reference laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I, column 1, shall be designated in accordance with the procedure referred to in Article 14(2).

[F1 2. The responsibilities and tasks of the Community reference laboratories, in particular with regard to coordination of their activities and those of the national reference laboratories, shall 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 14(3).]

3. Member States shall designate national reference laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I, column 1. The names and addresses of laboratories shall be communicated to the Commission.

[F1 4. Certain responsibilities and tasks of the national reference laboratories, in particular with regard to coordination of their activities and those of the relevant laboratories in the Member States designated under Article 12(1)(a), 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 14(3).]

Textual Amendments

F1 Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.

Article 12 U.K. Approval of laboratories, quality requirements and approved testing methods

1. Laboratories participating in control programmes pursuant to Articles 5 and 7 shall, for the purposes of analysing samples to test for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1:

(a) be designated by the competent authority; and

(b) apply quality assurance systems that conform to the requirements of the current EN/ISO standard at the latest within 24 months of entry into force of this Regulation or within 24 months of the addition of new zoonoses or zoonotic agents to Annex I, column 1.

2. Laboratories shall regularly participate in collaborative testing organised or coordinated by the national reference laboratory.

3. Testing for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1, shall be carried out using the methods and protocols recommended by international standardisation bodies, as reference methods.

Alternative methods may be used if they have been validated in accordance with internationally recognised rules and offer equivalent results to those obtained by the relevant reference method.

[F1 Where necessary, other methods for testing may be approved 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 14(3).]

Textual Amendments

F1 Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.