Authorisation process
Authorisation process
Phase I: Substances of very high concern (SVHC)
Registry of SVHC intentions until outcome
Member States or ECHA (at the request of the European Commission) inform all interested parties of their intention to propose the substance for identification as a substance of very high concern (SVHC).
Preparing the SVHC dossier
The proposal, which must be prepared according to the requirements given in Annex XV to REACH, should include two main parts:
Part I
provides the data and justification for identifying the substance as a substance of very high concern (SVHC).
Part II
includes further information relevant for the follow-up process (the uses, volumes and possible alternatives to the substance).
Learn moreThe proposal (Annex XV dossier) for identifying the substance as an SVHC is submitted to ECHA. There are two submission windows per year for SVHC dossiers.
ECHA will assess the proposal according to Annex XV to REACH, and if the dossier passes the accordance check, the proposal will be published on ECHA’s website. Learn more
Consultation
After the proposal is published, interested parties are invited to submit comments or provide further information during the consultation period (45 days from the date of publication).
Comments provided are normally considered non-confidential and will be made available to the public on ECHA’s website after the end of the consultation period.
Confidential information can also be submitted (with a justification), and will only be shared with the Member State Committee (where the case is referred to the committee).
The Member State who submitted the SVHC proposal or ECHA will prepare responses to any comments received.
Consultations occur twice per year. The focus of the SVHC consultation is on substance identity and hazard properties. Comments received on uses, and volumes per use, exposure, alternatives and risks will be taken into account in later steps of the authorisation process.
Adding substances to the Candidate List
If no comments challenging the identification are received, the substance is included directly in the Candidate List.
When comments are received that provide new information or challenge the basis for identifying the substance as an SVHC, both the proposal and the comments are referred to the Member State Committee (MSC) for agreement.
If the committee does not reach a unanimous agreement, the matter is referred to the European Commission for final decision making.