Submission of CLH dossiers

Who can submit CLH intentions and dossiers?

Member State competent authorities (MSCAs) may propose:

  • a new harmonised classification and labelling (CLH),
  • a revision of an existing CLH, for any substance that is under the scope of the CLP Regulation (Article 37(1)) or
  • CLH for active substances in biocidal products or plant protection products

Manufacturers, importers or downstream users may propose CLH for those substances:

  • which are not active substances in biocidal products or plant protection products
  • 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)).

Important: Manufacturers, importers or downstream users are required to have a REACH-IT account to submit a CLH intention or dossier.

 

Before preparing and submitting a CLH dossier

Before preparing a CLH dossier, please check the Registry of Intentions. It contains a list of substances for which the Agency has already received an intention for a CLH dossier submission.

A CLH dossier for the same substance should preferably not be submitted by two or more parties. Anyone with relevant information about the substance may bring this to the attention of the party submitting a CLH dossier during the early stages of the process, or provide such information during the public consultation.

The substances currently undergoing public consultation can be found on the ‘Harmonised Classification and Labelling consultations’ page.

A CLH intention is sent through a specific webform, which is also used to submit CLH dossiers and Response to Comments documents. Following the submission of the CLH intention, dossier submitters can contact ECHA at classification (at) echa.europa.eu if they need support, or if details of the dossier have to be discussed.

 

Preparing a CLH dossier in IUCLID format

The CLH dossier contains a technical dossier in IUCLID format and an attached CLH report. Further details on the contents of the technical dossier and the CLH report can be found in the Guidance on the preparation of CLH dossiers and in the CLH report format template. These documents give an overview of what to consider and how to prepare a CLH dossier. 

The CLH report should contain enough information to be a stand-alone document that will be published on ECHA’s website during the public consultation. It should not however contain any confidential information. 

Content of the CLH dossier

The CLH dossier should contain:

  • the identity of the substance,
  • the proposed CLH (including specific concentration limits or M-factors, if appropriate),
  • a scientific justification for the proposal,
  • and detailed study summaries of the relevant studies.

The dossier also needs to contain a justification that action is needed at EU level if hazard classes other than carcinogenicity, mutagenicity, reproductive toxicity (CMR) and respiratory sensitisation are proposed, unless the substance is an active substance in biocidal products or plant protection products.

The CLH report should be in the format provided by ECHA. Besides the CLH report, an Annex to the CLH report can also be prepared, which may be compiled from draft assessment reports (DARs), competent authority reports (CARs) and/or other sources.

This annex is used to present study references, detailed study summaries and results

 

How to submit a CLH dossier?

The CLH dossier should be prepared with the latest version of IUCLID and submitted to ECHA using the specific webform. Manufacturers, importers or downstream users must have a REACH-IT account before submitting a dossier, as some fields in the webform require information from the REACH-IT account. Guidance documents listed on this page offer more information on the preparation of CLH dossiers.

 

Any fees to be paid?

Where a CLH of a substance is proposed by a manufacturer, importer or downstream user for hazard classes other than CMR or respiratory sensitisation, it must be accompanied by a fee.

The fees are dependent on the company size. Small and medium-sized enterprises (SMEs) can benefit from a reduced fee. Details on the fees are outlined in Commission Regulation (EU) No 440/2010 (Fee Regulation).

Step-by-step instructions for assessing the company size category are available on the ECHA website on the page "SME fees under REACH and CLP".

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