CLH Dossier Preparation

The CLP Regulation specifies that Member State Competent Authorities (MSCAs) as well as manufacturers, importers or downstream users may submit proposals for harmonised classification and labelling (CLH proposals) of substances to the European Chemicals Agency (ECHA) (Article 37, CLP).

Manufacturers, importers and downstream users may propose CLH for those substances

  • which are not active substances in biocidal products or plant protection products, and
  • provided that 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)).

Such proposals would normally pertain to any of the carcinogenicity, germ cell mutagenicity and reproductive toxicity (CMR) or respiratory sensitisers hazard classes (and differentiation(s) within the hazard class where applicable), but also to any other hazard classes or differentiations on a case-by-case basis if justification for action at EU level is provided in the proposal (Article 36(1) and (3), CLP). CLH proposals must be submitted to ECHA in the form of a dossier (hereinafter referred to as ‘CLH dossier’) prepared in accordance with the requirements of the CLP Regulation (see Section 3.3). The provisions of Title V of the CLP Regulation on the harmonisation of classification and labelling also apply to active substances in plant protection products (PPP) and biocidal products (BP), regulated by Regulation (EC) No 1107/2009 (the PPPR) and Regulation (EU) No 528/2012 (BPR), respectively (Article 36(2), CLP). With regard to these substances, the harmonisation of classification and labelling should normally apply to all hazard classes.

Our service with regard to CLH

  • Preparation of the CLH-report with and without IUCLID
Dr Michael Cleuvers Director Products & Markets
+49 214 20658-0 +49 214 20658-200 send mail

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