Authorisation process
Authorisation process
Phase II: Recommendation for inclusion in the Authorisation List
Phase II takes about one to one and a half years and consists of the following steps:
Prioritisation
ECHA regularly assesses the substances from the Candidate List to determine which ones should be included in the Authorisation List as a priority.
This prioritisation is based primarily on information in registration dossiers on uses and volumes of the substance in the scope of authorisation. It also takes into account information received during the SVHC consultation or other sources, if relevant.
Priority is given to substances with :
Additional aspects relevant for the recommendation can be considered.
Learn moreDraft recommendation
Based on the prioritisation, a number of substances are proposed in the draft recommendation. For each substance, the draft recommendation includes:
The sunset date from which the placing on the market and use of a substance is prohibited, unless an authorisation is granted or the use is exempt from authorisation.
The latest application date by which applications must be received if the applicant wants to continue placing the substance on the market or using it after the sunset date.
Review periods for certain uses, if any.
Uses exempted from the authorisation requirement, if any.
Consultation
ECHA’s draft recommendation is submitted for consultation, which typically runs for three months once every one to one and a half years.
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Comments are invited on:
- Uses in the scope of authorisation and respective volumes.
- Latest application and sunset dates, complexity of supply chains and review periods.
- Uses that should be exempted.
The comments are published at the end of the consultation. Responses to the comments are provided with the final recommendation.
MSC opinion
The Member State Committee provides an opinion on the draft recommendation to ECHA, taking into account the comments received during the consultation.
Recommendation and inclusion in the Authorisation List
ECHA finalises the recommendation, taking into account the MSC opinion and the comments received during the consultation. The recommendation is then submitted by ECHA to the European Commission.
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The European Commission decides on the substances to be included in the Authorisation List and on the final entries (sunset date, latest application date, review period, exemptions).
The European Commission decision is published in the Official Journal and the Authorisation List is updated on ECHA’s website.
A substance cannot be used without authorisation after the ‘sunset date’.