ECHA Guidance on Preparation of Harmonized Classification and Labeling Dossier

The European Commission Regulation, (EC) No. 1272/2008 introduces in all countries of the EU a new system of classifying and labeling of chemicals and mixtures based on the UN’s Globally Harmonized System (GHS). It seeks to have the industry identify the hazards associated with the chemicals and mixtures they produce and communicate these hazards to other users in the supply chain for safe handling.

Under the regulation, the industry is required to assume a standard classification and labeling of chemicals and mixtures. This is more critical where more than one company is producing the same chemical and subsequently assumes a different classification and labeling. It is only logical that every chemical, irrespective of the production site, should have a standard hazard classification and labeling.

The regulation allows the industry to make proposals on the classification and labeling standards which can then be used by other players to achieve uniformity. To make such proposals, the ECHA published guidance to the industry on the preparation of dossiers for harmonized classification and labeling. The proposals can cover the hazard classes of carcinogenicity, germ cell mutagenicity, reproductive toxicity (CMR) or respiratory sensitisers (RS).

According to the ECHA guidance, proposals for harmonisation of classification and labelling of substances is governed by the Article 37 of the CLP Regulation, which provides that:

  • A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.
  • A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.
  • Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of a substance in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2).

Having outlined who can submit a harmonized classification and labeling proposal, the guidance lays down the substances for which such proposals can be submitted- only those substances that meet the conditions set out in the Annex I of the CLP Regulation:

  • Carcinogenicity, Category 1A, 1B or 2;
  • Germ cell mutagenicity, Category 1A, 1B or 2;
  • Reproductive toxicity, Category 1A, 1B or 2;
  • Respiratory sensitisation, Category 1

Once a company has identified a need for submitting a proposal, the guidance document outlines the stages of the proposal preparation, beginning with identification of the initial concern, and ending with inclusion in Annex VI of the CLP Regulation.

Certain conditions can trigger the preparation of a harmonized classification and labeling (HCL) dossier. If a Member State Competent Authority (MSCA)carries a substance evaluation, based on the REACH regulation and concludes that the substance is CMR or RS, then a HCL dossier can be prepared. Other conditions as captured in the guidance include if a MSCA:

  • Discovers that new information on an already classified substance is available,
  • Receives information from a risk assessment carried out by a regulatory body outside the EU which concludes that the substance is a CMR or RS or that classification and labelling in another hazard class and/or differentiation may be justified
  • Receives information from someone in industry who is about to start manufacture of a substance that may be a CMR or RS substance, but who does not intend to submit a proposal for harmonised classification and labelling

It is important the industry understands their obligations under the CLP Regulation including submission of an HCL proposal to the agency for a smooth path to compliance and to help consolidate chemical hazard information. This is vital for clear communication throughout the supply chain and for the safety of human health and the environment.

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