In terms of REACH compliance, SVHC refers specifically to those substances that meet the hazard categories mentioned AND that have been placed by the Commission on the Candidate List of substances considered for authorization.
SVHC is a substance meeting one or more of the following criteria:
- Class 1 or 2 carcinogen, mutagen, or toxic for reproduction (CMR)
- Substance which is PBT (persistent, bio-accumulative and toxic) or vPvB (very persistent and very bio-accumulative) in accordance with Annex III of REACH
- Other substances for which there is evidence of equivalent degree of concern (e.g. endocrine disruptors)
It is inclusion of substances in the Candidate List that triggers additional duties for manufacturers, importers and users like notification of SVHC's in Articles. Article 33(1) of the REACH Regulation states that manufacturers and importers of articles are required to notify their customers of the presence of any Substances of Very High Concern (SVHC) in their products exceeding 0.1% by weight and provide instructions on safe use of the product within 45 days upon request from consumers or customers.
- Notification of SVHC present in an article with a concentration above 0.1% (w/w) and the total amount of the SVHC exceeds 1 tonne per annum per producer or importer.
- Communication on guidance of safe uses through SDS for articles containing a SVHC with a concentration above 0.1% (w/w).
- The Candidate List is also the basis for the Authorisation process under REACH. Substances included in the Candidate List will progressively be put forward for inclusion in the Authorisation List (Annex XIV of the REACH Regulation). Substances that will be included in the Authorisation List cannot be manufactured or imported in the EU from a specific date set by the Commission (the ‘sunset date’), except if the companies have obtained an Authorisation for their specific use(s). This Authorisation can either be granted because the risks are controlled or because the socioeconomic benefits outweigh the risks. The aim of Authorisation is to ensure that the risks from substances of very high concern are properly controlled and that these substances are progressively substituted by alternative substances or technologies.
A socio-economic analysis along with possible alternative substances as potential substitutes is required for authorization.
- SVHC Testing & Assessment can be performed at our certified business partners where a testing report will be provided indicating a presence and concentration of SVHC substance in a product and along with necessary REACH compliant declarations.