Regulation (EU) 2025/2455 CHAPTER VIII — DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 27–Article 29 · 3 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Amendment of Annexes I, II, III and V

Article 27

1. In order to ensure that Annex I lists all relevant Union legal acts pursuant to which chemicals data are generated or submitted to the Agencies or to the Commission, and in order to keep the common data platform up to date, as soon as new Union legal acts pursuant to which chemicals data are generated or submitted enter into force, or an existing Union legal act is amended to introduce provisions on the generation or submission of data, the Commission shall adopt delegated acts in accordance with Article 28 to amend Annex I by adding those Union legal acts to that Annex, where the Union legal act concerned did not amend Annex I accordingly. 2. The Commission is empowered to adopt delegated acts in accordance with Article 28 to amend Annex II to this Regulation by adding new reference values derived under Union law on medicinal products, taking into account advances in digitalisation and interoperability as well as the values’ relevance for other chemicals policy and regulatory areas. 3. In order to ensure that Annex III lists all Union legal acts pursuant to which regulatory processes on chemicals or groups of chemicals are undertaken by competent authorities of the Member States, the ECHA, the EEA, the EFSA, EU-OSHA or the Commission, and in order to keep the common data platform up to date, as soon as new Union legal acts pursuant to which new regulatory processes are established enter into force, or an existing Union legal act is amended to establish new regulatory processes, the Commission shall adopt delegated acts in accordance with Article 28 to amend Annex III by adding those Union legal acts to that Annex, where the Union legal act concerned did not amend Annex III accordingly. 4. The Commission shall adopt delegated acts in accordance with Article 28, where necessary to keep Annex V as complete as possible, and to keep the common data platform up to date, to amend Annex V by adding (a) any new Union legal act pursuant to which data on chemicals in articles or products are generated or submitted, as soon as it enters into force, unless it contains a provision adding that act to Annex V; (b) any existing Union legal act listed in Annex I which is amended in such a way that data on chemicals in articles or products are generated or submitted pursuant to it, as soon as the respective amending act enters into force, unless the amending act contains a provision adding that act to Annex V; or (c) any existing Union legal act listed in Annex I for which it has become apparent from further verification that data on chemicals in articles or products are generated or submitted pursuant to it.

Exercise of the delegation

Article 28

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3(4) and Article 27 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each five-year period. 3. The delegation of power referred to in Article 3(4) and Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3(4) or Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

Committee procedure

Article 29

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

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