The aim of having a harmonised classification of certain substances is to guarantee the protection of human health as well as the environment from those hazards that matter most. What is harmonised classification and Labelling (CLH)?
The CLP Regulation requires all substances to be classified, and labelled if hazardous. This is generally done by the manufacturer or importer of a substance/mixture. However, certain situations require that the classification of a substance is harmonised and made mandatory at community level to ensure adequate risk management throughout the European Union. This is could happen:
- When the substance is either carcinogenic, mutagenic, toxic for reproduction (CMR) or a respiratory sensitiser;
- When the substance is an active substance in biocidal or plant protection products;
- When it is justified that a classification at EU level is needed.
All classified substances by the European Commission are gathered together in a harmonised classification table (annex VI of CLP) and included in the C&L inventory.
All previously harmonised classifications from the previous legislation, the Dangerous Substances Directive (DSD), have been converted into CLP harmonised classifications.
The producer’s and importer’s responsibilities with regards to the harmonised classification
If a company wishes to place a product on the market, it must verify if the substance(s) contained in their product has a harmonised classification. If a harmonised classification and labelling exists, it is mandatory for the suppliers of the respective substance or mixture to apply this harmonised classification and labelling.
There are no harmonised classifications for mixtures as they are to be exclusively classified by the supplier.
Proposal to harmonise the classification of a substance
It is possible for a company or Member State to propose a harmonised classification and labelling of a substance across the European Union. The interested party who wants to propose a harmonised classification shall publish its intention to prepare a dossier in order for interested parties to draft their comments.
The harmonised classification and labelling dossier must contain the following information to be completed:
- Manufacturer information;
- The possible use(s) of the substance;
- The hazards related to the substance;
- Justifications explaining why action needs to be taken on the community level;
- Sufficient physical, toxicological and ecotoxicological hazard information.
You can find a link to ECHA’s website explaining in further detail the procedure to prepare a CLH dossier.
After receiving the proposal for the harmonised classification and labelling, ECHA will undertake a consultation phase which will last 45 days to allow interested stakeholders to submit their comments.
After this period, ECHA forwards all comments received to the Member State or to the company which has made the proposal, and invites them to defend their view on the comments.
The Risk Assessment Committee (RAC) of ECHA then reviews the proposal, the comments and the view of the dossier submitters, and finally will issue a scientific opinion on the proposal. This opinion will be forwarded by ECHA to the European Commission.
It is the European Commission which will finally decide on the proposed harmonised classification and labelling of the substance concerned. For that, the European Commission is assisted by REACH Regulatory committee involving representatives of the Member States.
- Table of harmonised entries in Annex VI to CLP
- C&L inventory
- ECHA webpage on harmonised classification and labelling
- ECHA webpage on CLH dossiers
- ECHA Question & Answer on Annex VI CLP
- Introductory Guidance on the CLP Regulation (section 21)
- Guidance on the preparation of dossiers for Harmonised Classification and Labelling