Authorisation

The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.

The route to authorisation starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC.

Substances with the following hazard properties may be identified as SVHCs:

 

  • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.
  • Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII.
  • Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.

The SVHC identification process includes a 45-day public consultation. Once a substance is identified as an SVHC, it is included in the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance, such as:

  • supplying a safety data sheet
  • communicating on safe use
  • responding to consumer requests within 45 days and
  • notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).

Adding SVHCs to the Candidate List

The intention to propose a substance for identification as an SVHC is published in the registry of intentions before the proposal is submitted, to inform industry and other stakeholders in advance of the submission.

The proposal is prepared according to Annex XV to REACH and includes two main parts. The first one provides the data and justification for identifying the substance as an SVHC. The second part, examined during the follow-up steps after the identification, includes information on volumes on the EU market, the uses and possible alternatives to the substance.

After publication of the proposal, anyone can comment on it or provide further information during the 45-day consultation. Comments can be made on the properties of the substance, its uses and alternatives.

If no comments challenging the identification are received, the substance is included directly in the Candidate List. Comments on uses and alternatives are collected and used at a later stage of the process, i.e. during the recommendation of substances for inclusion in the Authorisation List.

When comments are received that provide new information or challenge the basis for the identification as an SVHC, both the proposal and the comments are referred to the Member State Committee (MSC) to agree on the identification of the substance as an SVHC.

If the committee reaches a unanimous agreement, the substance is added to the Candidate List. If the committee does not reach a unanimous agreement, the matter is referred to the Commission.

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