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: 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 that laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.