Authorised Substances

Authorised substances are those listed in Annex XIII of REACH, which are in the process of being removed from the EU market.  For more details, see https://ttenvironmenta.wpengine.com/clp-knowledgebase/authorisation-list/ .

Authorised substance –placing on the market

If you are selling or reselling an Authorised substance, where on its own or in a mixture, you will need to:

• make sure that you, or your supplier hold a valid Authorisation, for details of the application process, see https://echa.europa.eu/regulations/reach/authorisation/applications-for-authorisation .
• inform your downstream users that the substance has been Authorised
• place the Authorised substance number on the product label
• include the Authorisation number, and information relating to Authorisation (such as uses advised against) in the SDS, and once updated, issue it to all relevant recipients

Note that applying for an Authorisation is an expensive and time-consuming process, and expert advice is likely to be required to help prepare an application.  Stringent conditions for handling any Authorised substance are likely to be imposed, and Authorisations are only valid for a certain number of years, as the principle behind Authorisation is to ban the substance from the EU market, and the idea is to allow its use temporarily while industry looks for a substitute.

Authorised substance – downstream user

If you are a downstream user of an Authorised substance, either by itself or (more likely) within a mixture , you should be notified of this fact by your supplier.  You are obliged to:

1. Check that the label for the product has an Authorisation Number (format REACH/xx/xx/x)
2. Check that the safety data sheet you receive from your supplier has an Authorisation Number (format REACH/xx/xx/x)  (note that if you are an industrial or professional user, and the substance or mixture is not classified as hazardous under CLP, you can request an SDS from your supplier)
3. Comply with the conditions described in the SDS
4. Notify ECHA, using REACH-IT, within 3 months of the first delivery of the substance to you after the Authorisation decision has been published by the European Commission, see https://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use

Your REACH-IT notification should include:

• name and contact details for your company
• authorisation number
• number of staff using the substance
• typical annual volume
• specific information required in the authorisation