Submission of CLH dossiers
- Getting started
- Testing methods and alternatives
Dossier Submission Tools
- Registration Process
- Notifying substances in articles
- Submitting downstream user notification of authorised uses
- Submitting a downstream user report for unsupported uses
- Submitting a downstream user report for classification differences
- How to submit and update your C&L notification
- Requesting an alternative chemical name in mixtures
- SPC Editor
- R4BP 3
- ECHA Cloud Services
- Interact Portal
- System-to-system submission service
- National Helpdesks
- Practical examples of exposure scenarios
- Practical examples of chemical safety reports
- Small and Medium-sized Enterprises (SMEs)
- Recommendations to registrants
- 1. Your registration obligations
- 2. Finding your co-registrants
- 3. Get organised with your co-registrants
4. Assessing hazard and risk
- Information requirements: 1 to 10 tonnes per year
- Information requirements: 10 to 100 tonnes per year
- Information requirements: 100 to 1000 tonnes per year
- Information requirements: 1000 tonnes or above per year
- Adaptations to the standard information requirements
- How to avoid unnecessary testing on animals
- Strategy for gathering your data
- 5. Creating your registration dossier
- 6. Submitting your registration dossier
- 7. Keeping your dossier up to date
- Why is it important to get it right?
- What is a substance?
- What is not a substance?
- How to characterise and identify your substance
- Four steps to successful substance identification
- Sector-specific support for substance identification
- How to change your substance identifier
- Substances of very high concern identification
How to apply for authorisation
- Are you affected by authorisation?
- Develop an application strategy
- Start preparing your application
- Notify ECHA and request a teleconference based information session
- Finalise your application
- Submit your application
- Engage during the opinion development
- Fulfil your obligations
- Submit a review report if you still need to use the substance
- Ask ECHA about authorisation applications
- Socio-economic analysis in REACH
- Submission of CLH dossiers
- Mixture classification
UK withdrawal from the EU
- Know your role
- Advice to companies
- Procurement and contracts
- ECHA accounts and EU Login
Technical completeness check
- Validation assistant
- Manual verification
- Failures and rejections
- Questions and answers
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 a CLH dossier, please check the ‘Registry of CLH Intentions until outcome’. 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 consultation.
The substances currently undergoing 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.
The CLH dossier consists of the CLH report and any other supporting information. The CLH report should be prepared according to the CLH report format template available on the ECHA website. Please note that there are also specific templates for the preparation of CLH dossiers for biocidal active substances and plant protection products.
The CLH report should contain enough information to be a stand-alone document that will be published on ECHA’s website during the 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
The CLH dossier should be 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".
- 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]
- CLH report format
- Impurities and (degree of) purity in CLP and in the CLH process [PDF][EN]
- Practical guide: How to submit a CLH dossier [PDF][EN]