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Harmonised classifications

The CLP also includes provisions for harmonised classification of substances. These apply for hazards of highest concern and for other substances on a case-by-case basis and aim at harmonising classification and labelling across the EU.

Proposals for the harmonised classification and labelling of a substance for highest concerns comprise proposals for inclusion in as well as for updating of Annex VI to CLP, for:

  1. respiratory sensitisation;
  2. mutagenicity;
  3. carcinogenicity;
  4. reproductive toxicity;
  5. endocrine disruption for human health and/or environment;
  6. persistent bioaccumulation and toxic (PBT) or very persistent, very bioaccumulative (vPvB) properties.

Only the EU Commission and Member States can propose a revision of an existing entry or when a substance is an active substance in biocidal or plant protection products.

Manufacturers, importers and downstream users can also submit such proposals but only if there is no existing entry in Part 3 of Annex VI to the CLP Regulation for such a substance in relation to the hazard class or differentiation covered by the proposal (Article 37(2)). On the other hand, if a manufacturer, importer or downstream user has new information which may lead to a change in the harmonised classification and labelling of a substance; he must contact and submit a proposal to the Competent Authority in one of the Member States in which the substance is placed on the market (CLP Article 37(6)).

More information on the submission of CLH dossiers can be found here : https://echa.europa.eu/regulations/clp/harmonised-classification-and-labelling 

Once a CLH dossier has been submitted, it will be examined by the Risk Assessment Committee (RAC) that will issue an Opinion, within 18 months of receipt of the proposal. RAC will examine the available evidence for all proposed hazard classes and may consider another category more appropriate for the classification of the substance after having examined the available information.

A crucial step for industry is the public consultation on the CLH proposal. It lasts 60 days and is a unique time window foreseen in the process to submit comments and additional information. In case additional information is submitted, it is strongly recommended to also update registration dossiers with this information.

A visual summarising the CLH process can be found on the ECHA website:

CLH Process

Ongoing consultations can be found here: https://echa.europa.eu/web/guest/harmonised-classification-and-labelling-consultation 

RAC’s opinions are published on ECHA's website https://echa.europa.eu/registry-of-clh-intentions-until-outcome together with the background document and the response to comments submitted during the Public Consultation.

The Opinion will be forwarded to the Commission. If the Commission finds that the proposed harmonised classification and labelling is appropriate, it will submit a draft decision concerning the inclusion of that substance in Part 3 of Annex VI to CLP.

After its inclusion, all manufacturers, importers and users of the substance in the EU shall classify the substance accordingly.

More information on the Committee for Risk Assessment (RAC) can be found here:https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment 

 

Last page update: 7 August 2025