The CLP also includes provisions for harmonised classification of substances to be applied directly. Proposals for the harmonised classification and labelling of a substance should comprise proposals for inclusion in as well as for updating of Annex VI to CLP and should normally be made if that substance fulfils the classification criteria for (CLP Article 36):
- respiratory sensitisation, category 1
- germ cell mutagenicity, categories 1A, 1B or 2
- carcinogenicity, categories 1A, 1B or 2; or
- reproductive toxicity, categories 1A, 1B or 2.
New entries in Annex VI for these endpoints can be proposed by the Member States. 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)).
Member States, manufacturers, importers and downstream users might also submit proposals for a harmonised classification to the Agency which refer to other substance properties if justification is provided demonstrating the need for harmonised classification and labelling at Community level.
More information on the submission of CLH dossiers can be found here : https://echa.europa.eu/web/guest/support/clh
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 45 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.
The slides in annex summarise the process and possible inputs.
Ongoing consultations can be found here: http://echa.europa.eu/web/guest/harmonised-classification-and-labelling-consultation
RAC’s opinions are published on ECHA's website 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 should classify the substance accordingly. See scheme .
More information on RAC can be found here: http://echa.europa.eu/web/guest/meetings-of-the-rac
Last page update: 1 October 2018