REACH Substances of Very High Concern

REACH Substances of Very High Concern (SVHCs) are chemicals that pose a serious threat to human health and the environment, as evaluated by the European Chemical Agency (ECHA). They are regulated through the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), a European Union law instated in 2007. The SVHC designation aims to replace dangerous substances with less dangerous alternatives over time, as these become available. SVHCs include substances classified as carcinogenic, mutagenic, or toxic for reproduction, as well as those labeled as persistent, bioaccumulative, and toxic (PBT), or very persistent and very bioaccumulative (vPvB) in REACH Annex XIII.1

In order for a substance to be identified as a SVHC, an EU member state or the ECHA must submit a proposal. A SVHC proposal provides data and justification for the claim, according to REACH Annex XV. Once a substance is recognized as hazardous, a second part of the dossier must include information on its presence in the EU market, its uses, and possible safer alternatives. When a substance is classified as a SVHC it is also added to the Candidate List, which mandates that suppliers and manufacturers supply a safety data sheet, communicate safe use practices, respond to consumer queries within 45 days, and notify ECHA if any product contains significant quantities of a SVHC (above 1 tonne per producer/importer per year) and if the SVHC can be found in the product at concentrations above 0.1% (w/w). After a proposal’s publication there is a 45-day consultation period, during which comments are accepted and reviewed. Proposals with no comments are automatically added to the Candidate List. If comments on a proposal challenge the basis for the inclusion of the substance as a SVHC, the Member State Committee must review them before adding the substance to the Candidate List.2 A substance on the Candidate List is then subject to REACH regulations – if their products contain more than 0.1% (w/w), manufacturers and importers must present customers with a notification and instructions on safe use.3

  1. Chemical Inspection Regulation Service
  2. Chemical Inspection Regulation Service
  3. Intertek

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