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

Article 34 Methods used for sampling, analyses, tests and diagnoses

1. Methods used for sampling and for laboratory analyses, tests and diagnoses during official controls and other official activities shall comply with Union rules establishing those methods or the performance criteria for those methods.

2. In the absence of the Union rules as referred to in paragraph 1, and in the context of official controls and other official activities, official laboratories shall use one of the following methods according to the suitability for their specific analytical, testing and diagnostic needs:

(a) available methods complying with relevant internationally recognised rules or protocols including those that the European Committee for Standardisation (CEN) has accepted; or

relevant methods developed or recommended by the European Union reference laboratories and validated in accordance with internationally accepted scientific protocols;

(b) in the absence of the suitable rules or protocols, as referred to in point (a), methods which comply with relevant rules established at national level, or, if no such rules exist, relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or

relevant methods developed and validated with inter or intra-laboratory methods validation studies in accordance with internationally accepted scientific protocols.

3. Where laboratory analyses, tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2 of this Article exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 37(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols.

4. Wherever possible, methods used for laboratory analyses shall be characterised by the relevant criteria set out in Annex III.

5. Samples shall be taken, handled and labelled in such a way as to ensure their legal, scientific and technical validity.

6. The Commission may, by means of implementing acts, lay down rules on:

(a) the methods to be used for sampling and for laboratory analyses, tests and diagnoses;

(b) performance criteria, analysis, test or diagnosis parameters, measurement uncertainty and procedures for the validation of those methods;

(c) the interpretation of analytical, testing and diagnostic results.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).