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Guidance on the preparation of an application for authorization
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Authorization List

Authorization

The authorization process applies for substances of very high concern (SVHC) that are placed on the Authorization List (REACH Annex XIV). SVHC that are included on the Candidate List go through a prioritization procedure to determine which will be included on Annex XIV. The authorization process is intended to ensure that these substances are properly controlled and progressively replace by suitable alternatives.

A substance on the Authorization List cannot be placed on the market or used after its designated sunset date. Unless specific exceptions apply, a substance on the Authorization List may be placed on the market only if an authorization has been granted for a specific use, or the use has been exempted from authorization.

 

Authorization List.

Manufacturers, importers or downstream users of a substance on the Authorization List may prepare and submit applications for authorization.

  • Authorization requires demonstrating that risks associated with use of a substance are adequately controlled or that the socio-economic benefits outweigh the risks.
  • An application includes a specification of the use applied for, a Chemical Safety Report, and analysis of alternatives, a substitution plan, and may include a socio-economic analysis.

 

Risk Assessment.

The ECHA Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) review the application. The committees prepare their draft opinions within 10 months of receipt of the application. The RAC and SEAC send their opinions to the European Commission, which prepares the draft decision.

  • Applicants have the opportunity to comment on the draft opinions before the opinions and authorization decision are finalized.
  • The whole process takes well over a year.

 

European Commission.

If the European Commission authorizes the use of the substance, the holder of the authorization must comply with its requirements.

  • The holders of the authorization must update the Safety Data Sheet and include the authorization number on the label.
  • Downstream users may use chemicals that have been authorized by a party further up the supply chain, but must comply with the conditions set out in the authorization and notify ECHA of their use of the substance.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.