(a)

paragraphs 3 and 4 are replaced by the following: ‘3. An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (the “Agency”) in accordance with Annex V. 4. The Agency shall: If the volume and the complexity of the application is such that the Agency cannot comply with the 45 day time limit referred to in the first subparagraph, point (d), the Agency shall inform the applicant of any extension of the time limit and of the reasons therefor, as soon as possible, and in any case before the end of that time limit. The Agency may extend the 60 day time limit referred to in the first subparagraph, point (d)(ii), if the volume and the complexity of the application is such that that time limit cannot be complied with and provided that the applicant submits a reasoned request for an extension before the expiry of the 60 day time limit. The Agency shall decide on such extension within 5 working days of the request. If the applicant does not complete the application, in accordance with Annex V, with the elements identified as missing by the Agency, within the time limit set in accordance with the first subparagraph, point (d)(ii), and the second and third subparagraphs, of this Article, the Agency shall reject the application. The Agency shall establish and communicate to the applicant without delay the date when the application is considered complete.’ ; acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application; upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs; verify that the application contains all the elements set out in Annex V; if necessary and within 45 days of receipt of the application: request the applicant to complete the application; and set an appropriate time limit of maximum 60 days for completion of the application. make the application and any supplementary information supplied by the applicant available to Member States; make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete; invite interested parties to submit information within 3 months of making the application available in accordance with point (f).

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.