Harmonised classification and labelling procedure

Manufacturers, importers or downstream users have to (self)classify and label hazardous substances and mixtures to ensure a high level of protection of human health and the environment.

For hazards of highest concern (carcinogenicity, mutagenicity, reproductive toxicity (CMR) and respiratory sensitisers) and for other substances on a case-by-case basis, classification and labelling should be harmonised throughout the EU to ensure an adequate risk management. This is done through harmonised classification and labelling (CLH).

Harmonised classifications are listed in Annex VI to the CLP Regulation and should be applied by all manufacturers, importers or downstream users of such substances and of mixtures containing such substances.

CLH can be proposed for substances without a current entry in Annex VI to CLP, or to those with an existing harmonised classification, which would need to be changed either due to availability of new information, new scientific or technical developments, changes in the classification criteria or based on the re-evaluation of existing data.

A Member State competent authority (MSCA), or a manufacturer, importer and downstream user of a substance can submit a CLH proposal to ECHA. This could happen in three situations:

  • Where a substance is either CMR or a respiratory sensitiser
  • When it is justified that a classification for a substance at EU level is needed for other hazard classes
  • To add one or more new hazard classes to an existing entry (under the conditions above)

Only MSCAs may propose:

  • A revision of an existing harmonised entry, for any substance that is under the scope of the CLP Regulation
  • When a substance is an active substance in biocidal or plant protection products

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