Authorization of SVHC substances

REACH knowledge base – Authorization of SVHC substances

REACH introduced restrictions on the use of certain “substances of very high concern”. These substances may only be used for uses specified in Annex XIV or for other purposes only when it has been authorized by the manufacturer/importer or downstream user.

The intention of the REACH Regulation is to put an end on the use of these substances by putting “pressure” on the industry, and make them to replace these substances with new, less hazardous ones.

In the light of all these, all manufacturers, importers and downstream users submitting an application for authorization should analyze the availability of alternatives and examine their risks and the technical and economic feasibility of the substitution.

 General rules of the authorization of SVHC substances

• Applications for authorization should be submitted to the Agency.
• The application for authorization can be submitted by the manufacturer, importer and/or downstream user of the substance. The application can be submitted by one or more persons.
• The application can be submitted for one substance or for a group of substances specified in Section 1.5 of Annex XI and it can be submitted for one or more uses. Applications can 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 usability of SVHC substances

• if it has a license for the given use
• if the given use is exempted from the restriction based on Article 58 of REACH
• if the date specified in Article 58 has not been reached, or
• if an application has been submitted 18 months before the deadline
• if the downstream user of the substance got a license for that use
• if a former member of the supply chain got a license for that use
• in mixtures, if its concentration does not reach the threshold for “classification”

Sunset date

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

After reaching the sunset date, the substance may be used only if the supplier has requested permission for the use of the substance, but the decision is still pending, or if we have our own license for the use.

Obligations of the license holders

License holders and downstream users, including downstream users who use the substance for a mixture, shall put the license number on the label before placing the substance – or the mixture containing the substance – on the market for an authorized use.  This should be immediately done as soon as the license number has been made publicly available.

Recommended article(s) in connection with SVHC substances:

SVHC substances candidate list