Designation of official laboratories
Article 37
1. The competent authorities shall designate official laboratories to carry out the laboratory analyses, tests and diagnoses on samples taken during official controls and other official activities, in the Member State in whose territory those competent authorities operate or in another Member State or a third country that is a Contracting Party to the Agreement on the European Economic Area. 2. Competent authorities may designate as an official laboratory a laboratory located in another Member State or third country that is a Contracting Party to the Agreement on the European Economic Area, subject to compliance with the following conditions: (a) appropriate arrangements are in place under which the competent authorities are enabled to perform the audits and inspections referred to in Article 39(1) or delegate the performance of such audits and inspections to the competent authorities of the Member State or third country that is a Contracting Party to the Agreement on the European Economic Area where the laboratory is located; and (b) that laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located. 3. The designation of an official laboratory shall be in writing and shall include a detailed description of: (a) the tasks that the laboratory carries out as an official laboratory; (b) the conditions under which it carries out the tasks referred to in point (a); and (c) the arrangements necessary to ensure efficient and effective coordination and collaboration between the laboratory and the competent authorities. 4. The competent authorities may only designate as an official laboratory a laboratory which: (a) has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples; (b) has a sufficient number of suitably qualified, trained and experienced staff; (c) ensures that the tasks conferred upon it as set out in paragraph 1 are performed impartially and which is free from any conflict of interest as regards the exercise of its tasks as an official laboratory; (d) can deliver in a timely manner the results of the analysis, test or diagnosis carried out on the samples taken during official controls and other official activities; and (e) operates in accordance with the standard EN ISO/IEC 17025 and is accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008. 5. The scope of the accreditation of an official laboratory as referred to in point (e) of paragraph 4: (a) shall include those methods of laboratory analysis, test or diagnosis required to be used by the laboratory for analyses, tests or diagnoses, when it operates as an official laboratory; (b) may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods; (c) may be defined in a flexible manner, so as to allow the scope of accreditation to include modified versions of the methods used by the official 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 by the national accreditation body prior to the use of those modified or new methods. 6. Where no official laboratory designated in the Union or in a third country that is a Contracting Party to the Agreement on the European Economic Area in accordance with paragraph 1 has the expertise, equipment, infrastructure and staff necessary to perform new or particularly uncommon laboratory analyses, tests or diagnoses, the competent authorities may request a laboratory or diagnostic centre which does not comply with one or more of the requirements set out in paragraphs 3 and 4 to carry out those analyses, tests and diagnoses.