Authorization of SVHC substances

REACH knowledge base – Authorisation of SVHC substances

REACH introduced restrictions on the use of certain substances of very high concern (SVHCs). These substances may only be used for the uses specified in Annex XIV, or for other uses only if authorisation has been granted to the manufacturer/importer or downstream user.

The aim of the REACH Regulation is to phase out the use of these substances by placing pressure on industry and encouraging the replacement of these substances with safer alternatives.

In light of this, all manufacturers, importers and downstream users submitting an application for authorisation should analyse the availability of alternatives and assess their risks, as well as the technical and economic feasibility of substitution.

General rules for the authorisation of SVHC substances

• Applications for authorisation must be submitted to the Agency.
• An application for authorisation may be submitted by the manufacturer, importer and/or downstream user of the substance. An application may be submitted by one or more persons.
• An application may be submitted for one substance or for a group of substances specified in Section 1.5 of Annex XI, and it may be submitted for one or more uses. Applications may be submitted for the applicant’s own use and/or for uses for which the applicant intends to place the substance on the market.

Rules on the use of SVHC substances

• if authorisation has been granted for the given use
• if the given use is exempt from the authorisation requirement under Article 58 of REACH
• if the date specified under Article 58 has not yet been reached, or
• if an application has been submitted at least 18 months before the deadline
• if the downstream user of the substance has been granted authorisation for that use
• if an upstream actor in the supply chain has been granted authorisation for that use
• in mixtures, if the concentration does not reach the threshold for classification

Sunset date

The use of the substance on its own, in mixtures or in articles may be continued until the so-called “sunset date” is reached. The sunset date is specified in Annex XIV.

After the sunset date, the substance may be used only if the supplier has applied for authorisation for that use and the decision is still pending, or if we have our own authorisation for that use.

Obligations of authorisation holders

Authorisation holders and downstream users, including downstream users who use the substance in a mixture, must place the authorisation number on the label before placing the substance—or the mixture containing the substance—on the market for an authorised use. This must be done without delay once the authorisation number has been made publicly available.

Recommended article(s) in connection with SVHC substances:

Candidate List of SVHC substances