(1)

Article 5 is amended as follows: 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). the following paragraph is inserted: ‘4a. Once the Agency considers the application to be complete, it shall request the opinion of the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 (the “Committee for Socioeconomic Analysis”). The Agency shall also request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006 (the “Committee for Risk Assessment”), in the case of an application for a new exemption, or where otherwise considered appropriate. The Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment: Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (d). The Agency shall send the final opinions of the Committees to the Commission within 12 months of the date on which the Agency considers the application to be complete. The Agency shall identify which parts of those opinions, including any attachments thereto are to be made publicly available on its website. The Agency shall make those parts, and any requests made in accordance with the second subparagraph, point (d), available to the public on its website. For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.’ ; shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency; shall assess whether the criteria in Article 5(1), point (a), are met; shall provide clear guidance to the Commission on granting, renewing or revoking an exemption; may request the applicant or third parties to submit, within a specified period, additional information; upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication; shall adopt their final opinions, taking into account the comments from the applicant. paragraph 5 is replaced by the following: ‘5. An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within 9 months of receipt of the opinions from the Agency pursuant to paragraph 4a, fourth subparagraph. The existing exemption shall remain valid until a decision on the application for renewal is adopted by the Commission.’ ; paragraph 8 is replaced by the following: ‘8. The Agency shall, in agreement with the Commission, establish a harmonised format for the applications as referred to in paragraph 3 as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any application to the Agency shall be made using that harmonised format and submission tools made available by the Agency.’ ; the following paragraph is added: ‘9. The Commission shall publish guidelines to facilitate the harmonised application of this Article.’ ;

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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.