Chemicals that are covered by an entry on Annex XIV of the REACH Regulation may only be used if the use is covered by an authorization or the use is outside the scope of the authorization (e.g. intermediate use). Annex XIV is known as the Authorisation List and currently there are 54 entries on the List. New entries are added based on recommendations from ECHA. The “pull” list for potential new entries is the “Candidate List”. This is a list of chemicals that have “SVHC” status. All chemicals that have SVHC status are potential candidates for inclusion on the Authorization List.
If you are a user of a chemical covered by an entry on the Authorisation List, your use will need to be covered by an authorisation. Authorisation means permission to continue using a chemical on the Authorization List for a time limited period for a specific use by specific users. The procedure for getting this permission is known as “application for authorisation”.
The application process is complex. To prepare the application reports, you will need to have expertise available to you in chemicals risk assessment, socio-economic analysis and knowledge on the alternative chemicals or technologies available for your specific use. Authorisation will only be granted if your application is complete, demonstrates that the risks coming your continued use are controlled, quantified and minimized and suitable alternatives are not available to you. For chemicals where adequate control cannot be demonstrated (e.g. non-threshold carcinogens), a socio-economic analysis must be submitted that demonstrates that the benefits from your continued use outweigh the monetized risks to your workers, humans via the environment, etc. as relevant for your case.
Our Authorisation Team here at REACHLaw has the expertise to help you prepare your application. We offer a full range of authorization services from giving advice to preparing the full application for you
Who can apply for Authorisation?
Manufacturers, importers, Only Representatives (ORs) and downstream users can apply and hold Authorisations for their own uses or for uses down their supply chain. It is important to note that the rules regarding who can be the Authorisation holder may have the potential to cause supply disruptions if there are missing links in the supply chain.
The REACHLaw Authorisation Team
Our Authorisation Team can help you navigate the application process from scoping to see if your specific use could be an exempted use, advise you on the application strategy to take, collect all the necessary information to prepare the application reports, prepare them following the ECHA guidance and submit them to ECHA via their IT system. Post submission, the team can assist you answering questions from the ECHA committees during their assessment of your application, respond to comments made on your application in the public consultation and comment on the Opinion of the ECHA committees if needed.