(b)

Directive (EU) 2025/2456 of the European Parliament and of the Council of 26 November 2025 amending Directive 2011/65/EU as regards the reattribution of scientific and technical tasks to the European Chemicals Agency (Text with EEA relevance) · European Union

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.

← (g) · All articles · (a) →

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