Manufacturers, importers or downstream users will (self)classify and label hazardous substances and mixtures in order to ensure the protection of human health and the environment.
To ensure an adequate risk management for hazards like carcinogenicity, mutagenicity, reproductive toxicity (CMR) and respiratory sensitizers, classification and labelling should be harmonized throughout the EU. This is done through harmonized classification and labelling (CLH), that are listed in Annex VI to the CLP Regulation.
The CLH can be proposed for substances that do not have an entry in Annex VI of the CLP, or for substances with an existing harmonized classification that needs to be modified due to the availability of new information or the emergence of new scientific or technical developments, or for substances that need to be reevaluated based on existing data.
The CLH proposals can be submitted to ECHA by either a state competent authority (MSCA) or a manufacturer, importer, and downstream user.
The CLH process get initiated when ECHA receives an intention to prepare a CLH dossier by an MSCA or manufacturer, importer or downstream user. After the receival of intention, a substance identity check is performed, after which ECHA publishes the intentions on the Registry of Intentions on its website.
The CLH is designed to prevent situations in which two or more parties submit proposals for the same substance at the same time. During the early stages of the process, anyone can provide information relevant to the proposed risk classification for a substance or provide that information during the consultation process.
Interested parties can follow the progress of a proposal through the CLH process, starting from the notification of the intention to the adoption of the opinion of the Committee for Risk Assessment (RAC). The advance notice allows interested parties to prepare and plan for future comments.
Those who know something about the identity or hazard properties of a substance are encouraged to provide this information to the dossier submitter during the early stages of the process, or at the very least during the consultation phase.
The status of an opinion adopted by RAC is indicated as ‘Opinion Adopted’.
Recently two intentions have been received for:
