Regulation (EU) 2017/625 of the European Parliament and of the CouncilDangos y teitl llawn

Article 93 Designation of European Union reference laboratories

1. The Commission shall, by means of implementing acts, designate European Union reference laboratories in the cases where a decision has been taken to establish such a laboratory in accordance with Article 92.

2. The designations provided for in paragraph 1 shall:

(a) follow a public selection process; and

(b) be limited in time and with a minimum period of five years, or reviewed regularly.

3. European Union reference laboratories shall:

(a) operate in accordance with standard EN ISO/IEC 17025 and be accredited in accordance with that standard by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008. The scope of that accreditation:

(i)

shall include all the methods of laboratory analysis, test or diagnosis required to be used by the laboratory when it operates as a European Union reference laboratory;

(ii)

may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods;

(iii)

may be defined in a flexible manner, so as to allow the scope of the accreditation to include modified versions of the methods used by the European Union reference laboratory when the accreditation was granted or new methods in addition to those methods, on the basis of the laboratory's own validations without a specific assessment, prior to the use of those modified or new methods, by the national accreditation body of the Member State where the European Union reference laboratory is located;

(b) be impartial, free from any conflict of interest, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as European Union reference laboratories;

(c) have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques applied in their area of competence, and support staff as appropriate;

(d) possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them;

(e) ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work;

(f) be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and

(g) where relevant, be equipped to comply with relevant biosecurity standards.

4. By way of derogation from point (a) of paragraph 3 of this Article, for the area governed by the rules referred to in point (g) of Article 1(2), the Commission may designate official laboratories, designated as such by the competent authorities on the basis of a derogation adopted pursuant to Article 41, as European Union reference laboratories irrespective of whether they fulfil the conditions provided for in point (a) of paragraph 3 of this Article.

5. By way of derogation from paragraphs 1 and 2 of this Article, the laboratories referred to in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 and the first paragraph of the Article 21 of Regulation (EC) No 1831/2003 shall be the European Union reference laboratories having the responsibilities and performing the tasks referred to in Article 94 of this Regulation in the areas respectively of:

(a) GMOs and genetically modified food and feed; and

(b) feed additives.

6. The confidentiality obligations of staff, referred to in Article 8, shall apply mutatis mutandis to staff of the European Union reference laboratories.