Authorisation

The authorisation procedure aims to assure that the risks from Substances of Very High Concern are properly controlled and that these substances are progressively replaced by suitable alternatives while ensuring the good functioning of the EU internal market.

Substances with the following hazard properties may be identified as Substances of Very High Concern (SVHCs):

  • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) No 1272/2008 (CMR substances)
  • Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH (Annex XIII)
  • Substances identified on a case-by-case basis, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances

After a two-step regulatory process, SVHCs may be included in the Authorisation List and become subject to authorisation. These substances cannot be placed on the market or used after a given date, unless an authorisation is granted for their specific use, or the use is exempted from authorisation.

Manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation.