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Harmonised Classification and Labelling (CLH)

The need for safety has made it a necessity for manufacturers, downstream users, and importers to classify and label any substance or mixture that is considered hazardous. This will help ensure that human health and the environment are well protected.

The classification and labelling of hazardous substances that are considered dangerous to a large extent including mutagenicity, carcinogenicity, reproductive toxicity (CMR), and respiratory sensitisers, as well as other several other substances ought to be harmonised all through the EU. This will help in ensuring that risk is well managed to a suitable level. The best way to achieve this is through harmonised classification and labelling (CLH).

Furthermore, harmonised classifications are listed in Annex VI to the CLP Regulation. The harmonised classifications approach applies to all manufacturers, downstream users, or importers of these substances as well as certain mixtures that contain the substances.

In addition, it is possible to propose CLH for certain substance, even if these sustances are a current entry in Annex VI to CLP. CLH can also be proposed to sustances with existing harmonised classification, although, there may be a need to modify them as a result of a new information, new technical or scientific developments, and variations in the classification criteria. The changes can also occur if the current data on available is re-evaluated.

ECHA offers stakeholders like a Member State competent authority (MSCA), an importer, manufacturer, and downstream user of a substance, the opportunity of submitting a CLH proposal to them. This can occur from any of the three conditions listed below:

  • The substance is either a respiratory sensitiser or CMR.
  • It is justified that other hazard classes are dependent on the classification for the substance at EU level.
  • A situation whereby there is need to include additional hazard classes to an existing entry.

Only MSCAs can propose:

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

The steps involved in the CLH process include:

  • CLHintention
  • Dossier submission
  • Accordancecheck
  • Publicconsultation
  • RACopiniondevelopment
  • AdoptedRACopinion
  • Inclusionin AnnexVI
  • Resubmission