Submission of CLH dossiers
Who can submit a CLH proposal?
Member State competent authorities may propose
- a new harmonised classification and labelling (CLH), or
- a revision of an existing CLH, for any substance that is under the scope of the CLP Regulation (Article 37(1) ).
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)).
Important: Manufacturers, importers and downstream users are required to have a REACH-IT account to submit a CLH intention or dossier.
Before submitting a CLH proposal, it is recommended to check the Registry of Intentions (RoI), which 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 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 proposal during the early stages of the process, or provide such information during the public consultation of the dossier.
The substances currently undergoing public consultation can be found on the Harmonised classification and labelling current consultations page.
The Registry of Intentions provides information on the planned submissions of CLH dossiers.
Following the submission of the CLH intention, dossier submitters can contact ECHA at classification (at) echa.europa.eu should they require support, or if details of the dossier need to be discussed.
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 supporting documentation: Guidance on the preparation of CLH dossiers and CLH report format (both undergoing revision). These documents give an overview of what to consider and how to prepare the CLH dossier. Before the publication of the revised Guidance and Data Submission Manual on the submission of CLH dossiers, you are encouraged to contact the Classification Unit using the following address: classification (at) echa.europa.eu
The CLH report should not contain any confidential information. It should also contain enough information to be a stand-alone document that will be published on the ECHA website.
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 other hazard classes than carcinogenicity, mutagenicity and 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.
The CLH dossier should be prepared with the latest version of IUCLID and submitted to ECHA using the specific webform below. Manufacturers, importers and downstream users are required to have a REACH-IT account before proceeding with the submission of the dossier, as some fields in the webform require information from the REACH-IT account. Guidance documents listed on this page are available and 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".
An online tool ("GHS converter") in German and English that helps SMEs to familiarise themselves with GHS/CLP is provided by Berufsgenossenschaft Rohstoffe und chemische Industrie (BG RCI) on their website.
This tool has not been validated at European level and there is no guarantee on the correctness of the classification and labelling details provided by the tool.
- Introductory Guidance on the CLP Regulation [PDF] [EN]
- Guidance on the Application of the CLP Criteria [PDF] [EN]
- Guidance on the preparation of dossiers for harmonised classification and labelling [PDF] [EN]
- Guidance on labelling and packaging in accordance with the CLP Regulation [PDF] [EN]
- Guidance on Classification and Labelling notification [PDF] [EN]
- CLH report format