2.

The Member State concerned shall communicate to the applicant a detailed statement of the grounds for seeking a derogation pursuant to paragraph 1 and shall seek to reach an agreement with the applicant on the proposed derogation. If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall inform the Commission. In that case, the Commission: may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned; shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 82(3). The Commission’s decision shall be addressed to the Member State concerned and the Commission shall inform the applicant thereof. The Member State concerned shall take necessary measures to comply with the Commission’s decision within 30 days of its notification.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.