Authorisation is required for the use of substances of very high concern (SVHCs) (REACH, Title VIII). Without authorisation, you may neither use these substances, nor place them on the market for use. Authorisation is always specific to the use of a substance, i.e. a substance requiring authorisation may be used and/or placed on the market only for the uses for which it is explicitly authorised.

Manufacture of an SVHC does not require authorisation.

Substances of very high concern (SVHCs)

Substances with the following hazardous properties can be identified as SVHCs:

  • Category 1A and 1B CMR* substances
  • Persistent, bioaccumulative and toxic substances (PBTs)
  • Very persistent and very bioaccumulative substances (vPvBs)
  • Substances for which there is scientific evidence of probable serious effects to human health or the environment which are of equally high concern as those of the other substances listed (such as substances having endocrine disrupting properties)

*carcinogenic, mutagenic and reprotoxic (REACH, Article 57 and Annex XIV)

The substances subject to authorisation are listed in Annex XIV of the REACH Regulation.

Inclusion of substances in Annex XIV is a two-step process:

  1. Inclusion of a substance in the candidate list
  2. Inclusion of the substance in Annex XIV of the REACH Regulation

Candidate list

ECHA includes all substances in the candidate list that can be considered for inclusion in Annex XIV of the REACH Regulation. The list of candidates is continually updated.

Duties of suppliers of substances on the candidate list

Should a substance be added to the candidate list and you are a supplier of it or of articles containing it, its inclusion immediately gives rise to obligations for you. You are required to:

  • provide a safety data sheet (REACH, Article 31);
  • provide information on safe use (REACH, Article 33);
  • respond to requests for information from consumers within 45 days (REACH, Article 33);
  • submit registration of articles to ECHA should they contain substances on the candidate list above a certain tonnage threshold (REACH, Article 7)

Annex XIV

Annex XIV of the REACH Regulation lists all substances subject to authorisation. The European Commission determines which substances on the candidate list are to be included in Annex XIV.

All new entries of SVHCs in Annex XIV are assigned an expiry date. After this date you may neither use the substance concerned without authorisation nor place it on the market without authorisation, unless your intended use of the substance subject to authorisation is explicitly exempted from authorisation in Annex XIV.

Authorisation procedure

You must submit an application for authorisation to ECHA no later than 18 months before the deadline specified in Annex XIV. Note that applications for authorisation may be submitted to ECHA only within defined quarterly submission periods.

The templates required for the application for authorisation can be downloaded from the ECHA website.

Obligations for holders of authorisations and downstream users

Where an approval is granted by the European Commission, it applies exclusively to one or more uses.

As the holder of the authorisation you are required to update the safety data sheet (e.g. include the identified authorised uses) and apply labels showing the authorisation number before placing the substance or a mixture containing the substance on the market.

If you are a downstream user of an authorised substance, you may use it only under the conditions for which an authorisation has been granted. As a downstream user you are obliged to notify ECHA of your use within three months of taking delivery of the substance for the first time.