Regulation 2024/2865 - Amendment of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures - Main contents
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Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2024/2865 |
| Regdoc number | PE(2023)108 |
| Original proposal | COM(2022)748  |
| CELEX number i | 32024R2865 |
| Document | 23-10-2024; Date of signature |
|---|---|
| Signature | 23-10-2024 |
| Effect | 10-12-2024; Entry into force Date pub. +20 See Art 2.1 01-07-2026; Application Partial application See Art 2.2 01-01-2027; Application Partial application See Art 2.3 |
| Deadline | 30-06-2026; See Art 2.4 31-12-2026; See Art 2.5 |
| End of validity | 31-12-9999 |
Official Journal of the European Union |
EN L series |
2024/2865 |
20.11.2024 |
REGULATION (EU) 2024/2865 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 October 2024
amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
In order to keep pace with globalisation, technological developments and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3). While under Regulation (EC) No 1272/2008 it is assumed that all economic operators in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore necessary to require that there be a supplier established in the Union which ensures that the substance or the mixture in question meets the requirements set out in Regulation (EC) No 1272/2008 when it is being placed on the market, including via distance sales, such as via online market places. Such provision, together with requirements in Regulations (EU) 2019/1020 (4), (EU) 2022/2065 (5) and (EU) 2023/988 (6) of the European Parliament and of the Council, would improve compliance with and enforcement of Regulation (EC) No 1272/2008 and thereby ensure a high level of protection of human health and the environment. In order to avoid situations where a consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in Regulation (EC) No 1272/2008 acts in the course of an industrial or professional activity. |
(2) |
Substances containing more than one constituent are complex substances. From a toxicological point of view, substances containing more than one constituent are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (7), which aims to minimise animal testing, data on substances containing more than one constituent are to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance are normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents are available, substances containing more than one constituent should be evaluated and classified following the same classification rules as mixtures. |
(3) |
Scientific data on certain substances containing more than one constituent extracted from plants have indicated that specific constituents considered in an isolated way can have hazard properties that might not be expressed in the substance as a whole. Therefore, in order to allow time for a scientific evaluation of the appropriateness of requiring substances containing more than one constituent extracted from plants to follow the rules on classification of substances containing more than one... |
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