European Commission Updates List of Harmonised Classification and Labelling

On 5 January 2024, the European Commission took a significant step to improve the regulatory landscape by adopting a Delegated Regulation (2024/197) for an adaptation to technical progress within Regulation (EC) 1272/2008. This regulation, commonly known as the CLP Regulation, deals specifically with the classification, labelling, and packaging of substances and mixtures. The regulation came into force on 25 January 2024.

The main objective of the Delegated Regulation is to make important updates to Table 3 of Part 3 of Annex VI to the CLP Regulation, which contains the list of harmonised classification and labelling (CLH) of hazardous substances. The proposed changes include the introduction of 28 new entries and the revision of 24 existing entries. The complete list is available here. The scientific assessment of these substances has been carried out in collaboration between the European Chemicals Agency (ECHA), its Committee for Risk Assessment (RAC) and the Member States authorities for decision-making at the Commission.

This proposed updates demonstrates the European Commission's commitment to keeping abreast of scientific and technical progress. The updates will play a crucial role in streamlining the harmonised classification and labelling processes and promoting consistency across the European Union. Manufacturers, importers, and downstream users are urged to stay informed about these proposed changes, as the new classifications will apply from 1 September 2025.

Harmonised classification and labelling

Manufacturers, importers, or downstream users are required to (self-)classify and label hazardous substances and mixtures in order to ensure a high level of protection for human health and the environment.

For substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) and respiratory sensitisers classification and labelling should be harmonised across the EU to guarantee appropriate risk management. This is achieved through harmonised classification and labelling (CLH).

The harmonised classifications are listed in Annex VI to the Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP) Regulation. All manufacturers, importers, and downstream users of such substances should apply the harmonised classifications.

Proposals for CLH can be made for substances not currently listed in Annex VI to CLP. For substances with an existing harmonised classification changes may be made due to new information, scientific or technical developments, changes in classification criteria or re-evaluation of existing data.