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Authorisation

REACH aims to ensure that the risks resulting from the use of substances of very high concern (SVHCs) are properly controlled while ensuring a good functioning of the internal market and that these substances are progressively replaced where alternatives are technically and economically feasible.

The Authorisation process consists of 3 distinctive phases:

  • Phase 1: selection of substances for the candidate list, i.e. Substances of Very High Concern
  • Phase 2: Recommendations for inclusion in the Authorisation list
  • Phase 3: Applications for Authorisation (AfA)

More information: https://echa.europa.eu/authorisation-process 

SVHC: Candidate substances for authorisation

The first step is when a Member State or ECHA at the request of the Commission proposes a substance to be identified as a Substance of Very High Concern (SVHC). SVHCs identification focuses on:

  • CMRs (substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) N° 1272/2008 (CLP regulation),
  • PBTs (substances that are Persistent, Bioaccumulative or Toxic for the Environment), according to REACH (Annex XIII)
  • vPvBs (substances that are very Persistent and very Bioaccumulative) or according to REACH (Annex XIII)
  • Substances on a case-by-case basis that cause an equivalent level of concern (such as endocrine disruptors (EDs) or sensitisers).

The ambition is to have all currently known SVHCs included in the candidate list by 2020.

The intention to propose a substance as a SVHC is published in the Registry of Intentions (RoI) before the proposal is submitted by the Member State or ECHA at the request of the Commission. The proposal follows the principles outlined in Annex XV of REACH.

The SVHC identification process includes a Public Consultation (45 days).  If no comments are received, the substance is directly included in the Candidate List. When comments are received challenging the identification or providing new data, the Member States Committee is asked to agree to the identification (need for unanimous agreement). https://echa.europa.eu/substances-of-very-high-concern-identification-explained

Once a substance is identified as SVHC, it is included in the Candidate List. The inclusion in the Candidate List requires suppliers of the substance to:

  • supply a safety data sheet
  • communicate on safe uses
  • respond to consumers in 45 days
  • notify ECHA if the article they produce contains a SVHC in quantities > 1 ton per producer / importer per year and if the substance is present in those articles at a concentration > 0.1% (w/w)

Prioritisation for inclusion in the authorisation list (Annex XIV)

SVHCs may be included in the Authorisation List (Annex XIV of REACH) as a priority and become subject to authorisation. This means that these substances cannot be placed on the market or used after a given date, called the sunset date (SD), unless authorisation is granted for their specific use, or the use is exempted from authorisation.

Regarding the prioritisation process: REACH requires ECHA to recommend from the Candidate List priority substances for inclusion in Annex XIV, considering the comments received during the Public Consultation and the opinion of the Member States Committee. The EU Commission decides on the entries in Annex XIV. Prioritisation is based on information on the intrinsic properties wide dispersive use or high volumes. It is of key relevance for substances within the metals industry, such as As203, CrVI, Cd, borates,...

More information can be found here:https://echa.europa.eu/recommendations-for-inclusion-in-the-authorisation-list   

ECHA’s recommendation also includes the latest application data, review periods for certain uses and uses exempted from authorisation.

For both industry and EU/ national authorities, authorisation has been a ‘hot issue’, requiring capacity building and further information gathering. Please note that the authorisation process considered as very burdensome is discussed in the context of the REACH Revision (2025-2026)

More information can be found here: https://echa.europa.eu/regulations/reach/authorisation/recommendation-for-inclusion-in-the-authorisation-list  

Authorisation applications

The manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation for given uses. Before the latest application date (LAD), they have to apply for an authorisation for each of their uses, provided none of them is exempted.

Authorisation will be granted only to applicants that are able to demonstrate that:

  • in case of a threshold substance, the risks to human health and the environment for their uses are adequately controlled or
  • in case of a non-threshold substance, the socio-economic benefits of continued use outweigh the risks, and no suitable alternative substances or technologies are available.
    Depending on the application route, the application for an authorisation requires a Socio-Economic Analysis or an extended proof of adequate control and in both cases an assessment of alternatives.

Further information on the authorisation process and application, and more specifically on metals in this context, can be found on the Members’ webpages.

Useful information on the authorisation process and the strategy to apply can be found on the ECHA webpage: https://echa.europa.eu/applying-for-authorisation  

Last page update: 7 August 2025