Guidance on the preparation of dossiers for harmonised classification and labelling
Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (the CLP Regulation) entered into force on 20 January 2009. Title V of the CLP Regulation contains provisions for submission of proposals for harmonised classification & labelling. 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). 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)5 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. The hazard classes and categories in this document refer to those specified in the CLP Regulation. CLH dossiers received by ECHA after 1 January 2014 should not contain a classification proposal according to DSD. Until 1 June 2015, substances must also be classified according to the criteria in the Dangerous Substances Directive (DSD) (Article 61, CLP). However, considering the time it takes from submission of a CLH dossier until the Committee for Risk Assessment (RAC) forms an opinion on the proposed classification and the Commission includes the classification in an entry in Part 3, Annex VI, CLP, the opinions adopted by RAC will only cover classification according to the CLP Regulation.