Harmonised classification and labelling
Certain situations require that the classification of a substance is harmonised and made obligatory at Community level to ensure an adequate risk management throughout the European Community.
This could happen in three situations:
- Where the substance is either carcinogenic, mutagenic, toxic for reproduction or a respiratory sensitiser.
- When the substance is an active substance in biocidal or plant protection products.
- When it is justified that a classification at EU level is needed.
Member States, manufacturers, importers and downstream users may propose the classification and labelling of a substance to be harmonised across the European Union.
The intention to prepare a harmonised classification and labelling proposal is made public on the registry of intentions to allow interested parties to prepare their contribution to the process.
The harmonised classification dossier includes information on the manufacture and uses of the substances, its hazards and a justification that action is needed at Community level. The report must contain sufficient information to make an independent assessment of various physical, toxicological and ecotoxicological hazards based on the information presented.
After receiving the proposal, ECHA organises a public consultation period for 45 days. After this time, ECHA forwards all comments received to the Member State or those companies who had submitted the proposal and invites them to provide their view on the comments.
Risk Assessment Committee
The proposal, the comments and the views of the dossier submitters will be forwarded to ECHA's Risk Assessment Committee (RAC). The committee, comprising experts from the Member States, will issue a scientific opinion on the proposal, which ECHA will forward to the European Commission.
The Commission, assisted by the REACH Regulatory Committee involving representatives of the Member States, will then decide on the proposed classification and labelling of the substance concerned.
Information on Chemicals
Please note that the Data Submission Manual will be published after discussions on the CLH report format are finalised and not "soon after August 2014" as indicated in the Guidance on the preparation of dossiers for Harmonised Classification and Labelling.