Substances of very high concern must be authorized. These include:

  • Category 1 and 2 CMR substances*
  • Persistent, bioaccumulative and toxic (PBT) substances
  • Very persistent and very bioaccumulative (vPvB) substances
  • Substances for which there is scientific evidence of probable serious effects to human health or the environment and which present a risk equivalent to the level of concern raised by the other substances listed (e.g. substances with endocrine disrupting properties).

*Carcinogenic, mutagenic or reprotoxic
(REACH Regulation, Article 57 and Annex XIV)

For these substances, a list (Annex XIV of the REACH Regulation) is generated in which the substances subject to the authorization requirement are listed and assigned a date. Once the deadline stated in the list has passed, the substance concerned may neither be placed on the market, nor used, without authorization. Certain applications of a substance may be exempted from the authorization requirement. An application for authorization should be submitted no later than 18 months prior to the deadline stated in Annex XIV.

Where granted, authorization applies solely to one or more applications. Following the granting of authorization, a downstream user may use a substance only under the conditions for which the authorization was granted. Downstream users must notify the Agency of their application within three months of the first delivery of the substance.

The first step towards inclusion of a substance in Annex XIV of the REACH Regulation is the inclusion of the substance concerned in a "candidate list" at the ECHA (European Chemicals Agency) in Helsinki. The inclusion of a substance in the candidate list gives rise to immediate obligations for companies.