Article 1 · Commission Implementing Regulation (EU) 2024/2052

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Article 1 #

Implementing Regulation (EU) 2021/808 is amended as follows:

(1)Article 1 is replaced by the following:‘Article 1Subject matter and scopeThis Regulation lays down rules concerning the methods of analysis used for sampling and for laboratory analyses in relation to residues of pharmacologically active substances in the frame of national plans as defined in Article 3 of Commission Implementing Regulation (EU) 2022/1646^note. It also lays down rules for the interpretation of analytical results of these laboratory analyses.This Regulation applies to official controls aimed at verifying compliance with the requirements on the presence of residues of pharmacologically active substances.^note

(2)in Article 2, the second subparagraph is amended as follows:

(a)point (36) is replaced by the following:

(36)“reproducibility” means precision under conditions, where test results are obtained with the same method on identical test items in different laboratories with different operators using different equipment^note;

^note

(b)point (47) is replaced by the following:

(47)“units” means those units described in ISO 80000-1:2022^note and Council Directive 80/181/EEC^note;

^note^note

(3)in Article 3, in point (4), after the first subparagraph, a second subparagraph is added, as follows:‘When deviations from the criteria established in Tables 1 and 2 of Annex I have been observed during validation, impact of those deviations on the outcome of the validation shall be analysed in a documented traceable manner.’;

(4)in Article 7, the third paragraph is deleted;

(5)Annex I to Implementing Regulation (EU) 2021/808 is amended in accordance with the Annex to this Regulation.

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