What is a SVHC?
SVHC stands for “Substance of Very High Concern”. Substances may be identified as SVHCs when they:
- meet the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.
- are Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to REACH Annex XIII.
- cause an equivalent level of concern as CMR or PBT/vPvB substances, based on scientific evidence. Examples include substances which have endocrine disrupting properties. These substances are identified as SVHC on a case-by-case basis.
Who decides whether a substance is a SVHC?
Any Member State of the EU, or the European Chemicals Agency (ECHA) itself (upon request of the Commission), may propose the identification of a substance as an SVHC. Anyone may react to this proposal during a subsequent 45-day public consultation period. The final decision on the SVHC status of the substance is taken by ECHA’s Member State Committee – or, if the Member States cannot reach an agreement, by the European Commission. Once a substance is identified as an SVHC, it is included in the Candidate List” (of SVHCs for Authorisation).
What happens when a substance is identified as a SVHC?
Inclusion of a substance in the Candidate List affects its (downstream) suppliers:
- SVHC suppliers must: supply Safety Data Sheets for their substances.
- Mixture suppliers must: upon request of the customer, provide Safety Data Sheets for products that do not meet the criteria for CLP classification as hazardous, but contain at least one substance listed in the Candidate list in an individual concentration of ≥ 0,1 % by weight (for non-gaseous mixtures).
- Article suppliers must: notify ECHA if their article 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). They also must provide their customers with sufficient information to allow safe use of articles which contain more than 0.1% (w/w) of a SVHC, and upon request, to consumers within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
Further, REACH stimulates the gradual substitution of SVHCs by less dangerous substances or technologies, where technically and economically feasible. To this end, the substances on the Candidate List are frequently assessed by ECHA to determine which ones should be included in the Authorisation List.
Update: As of 5 January 2021, companies supplying articles containing SVHCs in a concentration above 0.1% (w/w) on the EU market have to submit information on these articles to the SCIP database. The SCIP notification obligations complement the abovementioned REACH communication and notification obligations for Candidate List substances in articles.
The Chemical Compliance Coach can help you to scan your products for substances on the Candidate List. Further, we can compile Safety Data Sheets for your products, or assist you with your REACH or SCIP notifications. Contact us for more information.