Authorisation Under the REACh Regulation (Annex XIV)

What is Authorisation under REACH?

The Authorisation process ensures risks posed by substances of very high concern (SVHCs) currently in use are properly managed and progressively replaced by safer alternatives. This happens through a two-step regulatory process involving the Candidate List and the Authorisation List.

The Candidate List contains substances identified as being of very high concern to human and/or environmental health. Once added to the list, the use of these substances by companies manufacturing, importing or using them (as stand-alone substances, mixtures or in articles) in concentrations greater than the 0.1 percent weight by weight threshold are obliged to provide the recipient of the article or the consumer with necessary information about safe usage.

Substances on the Candidate are then considered for inclusion in the Authorisation List. Once on the Authorisation List, a substance cannot legally be placed on the European Union (EU) market, or used after its sunset date, unless a manufacturer, importer or downstream user is granted a specific authorisation for that use, or if the use is exempted from authorisation, as per Annex IV of the REACH Regulation.

How do I make an application for Authorisation under the REACH Regulation?

Manufacturers, importers and downstream users can apply for specific authorisation to place a substance present on the Authorisation List (a substance of very high concern, or SVHC) on the market, or to use it in production. An application must include, at minimum, a chemical safety report, an evaluation of any available alternatives to that substance, and a plan detailing the eventual replacement of that substance over time. Authorisations are granted if the applicant demonstrates the hazards of using the SVHC can be mitigated adequately.

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