Production of CLH Dossiers for Harmonised Classification and Labelling

The CLP Regulation (EC) No. 1272/2008 implements the UN Globally Harmonised System (GHS) for chemical hazard classification in the EU, replacing the old Dangerous Substances Directive. Under REACH (1907/2006), the Biocides Regulation (528/2012), and the Plant Protection Products Regulation (1107/2009), the vast majority of chemicals (excluding pharmaceuticals) are now assessed for classification under CLP in Europe.

In the EU, severe classifications, such as Category 1 classifications for carcinogenicity, mutagenicity, or reproductive effects (the “CMRs”), have "downstream" consequences which may severely limit the use of products.

The process of harmonising GHS classifications under CLP in Europe is well underway, and any decisions made now may be relevant to chemical registration in many other areas of the globe as GHS classifications are also relevant worldwide.

Exponent regularly assists clients with classification issues and can provide the following services:

  • Advise, at an early stage, if downstream restrictions may arise;
  • Advise on strategy including review of legislative status and requirements and the further consideration of supporting data to determine whether proposed classifications are appropriate;
  • Prepare and submit IUCLID technical dossiers and harmonised classification and labelling (CLH) proposals;
  • Support clients during early discussions with the Member State Competent Authority (MSCA) and potentially provide expert technical advice at relevant EU meetings.

Under CLP, the MSCA and/or industry may submit proposals for the CLH of a substance to the European Chemicals Agency (ECHA). A CLH may be proposed for three different scenarios:

  • For an industrial chemical if it is a Category 1A, 1B, or 2 carcinogen, mutagen, or reproductive toxin, or a Category 1 respiratory sensitiser; or
  • For a biocide or pesticide active substance (proposed by MSCA only); or
  • To revise or remove the current classification and labelling of a chemical (proposed by MSCA only).

As such, manufacturers, importers, and downstream users may propose a harmonized classification and labelling 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)).

To propose a harmonized classification and labelling, a CLH dossier must be prepared. There are two parts to the process:

  1. Technical dossier: studies covering the appropriate areas for classification must be summarised in IUCLID 5. The following areas must be covered:

    • Physico-chemical properties: explosive properties, oxidising properties, flammability.
    • Environmental fate: ready biodegradability.
    • Ecotoxicology: acute aquatic studies.
    • Toxicology: acute toxicity, irritation, sensitisation, repeat dose toxicity, carcinogenicity, mutagenicity, toxicity to reproduction, developmental toxicity; and any mechanistic studies and human experience relevant to classification.

  2. CLH report: this summarises the relevant information from the technical dossier, enabling the proposed classification and labelling to be assessed independently of the technical dossier, or the studies themselves.

The technical dossier is prepared by either using the original study reports or, if available, an existing substance dossier in the appropriate format.

Once completed, the technical dossier and CLH report are assessed by ECHA’s Risk Assessment Committee (RAC). Following a public consultation period, the RAC will discuss the proposed classification and labelling and issue their opinion within 18 months of the proposal being submitted. This RAC opinion is then considered by the European Commission who will make the final decision on implementation of the recommendation.

Exponent can help clients prepare CLH dossiers by completing the technical dossier in IUCLID using original study reports or an available biocide/pesticide active substance dossier. This dossier will be completed in line with expected quality requirements. We can also complete the CLH report, either after completion of the technical dossier, or using an existing technical dossier; ensuring that the proposed CLH is as robust as possible.

In addition, Exponent has a successful record providing effective support at technical committees such as the RAC; and can assist in devising data collection strategies to address a proposed classification, or a potential classification issue.



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