Regulation (EU) 2017/625 of the European Parliament and of the CouncilShow full title

Article 40 Derogations from the condition for the mandatory accreditation for certain official laboratories

1. By way of derogation from point (e) of Article 37(4), competent authorities may designate the following as official laboratories irrespective of whether they fulfil the condition provided for in that point:

(a) laboratories:

(i)

whose sole activity is the detection of Trichinella in meat;

(ii)

that only use the methods of detection of Trichinella referred to in Article 6 of Commission Implementing Regulation (EU) 2015/1375(1);

(iii)

that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 37(1) and accredited in accordance with the standard EN ISO/IEC 17025 for the use of the methods referred to in point (ii) of this point; and

(iv)

that participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories for the methods they use for the detection of Trichinella;

(b) laboratories which only carry out analyses, tests or diagnoses in the context of other official activities, provided that they:

(i)

only use the methods of laboratory analysis, test and diagnosis referred to in Article 34(1) and point (a) or (b) of Article 34(2);

(ii)

carry out the analyses, tests or diagnoses under the supervision of the competent authorities or of the national reference laboratories in relation to the methods they use;

(iii)

participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories in relation to the methods they use; and

(iv)

have a quality assurance system in place to ensure sound and reliable results from the methods for laboratory analysis, test and diagnosis used.

2. Where the methods used by the laboratories referred to in point (b) of paragraph 1 of this Article require confirmation of the result of the laboratory analysis, test or diagnosis, the confirmatory laboratory analysis, test or diagnosis shall be carried out by an official laboratory which complies with the requirements set out in point (e) of Article 37(4).

3. The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.

(1)

Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on official controls for Trichinella in meat (OJ L 212, 11.8.2015, p. 7).