SVHC is the abbreviation for "Substances of Very High Concern".
An SVHC substance will usually meet one or more of the following criteria:
• It is classified as a category 1A or 1B carcinogen, mutagen or reproductive toxicant under regulation EC 1272/2008 (The Classification, Labelling and Packaging Regulation)
• It is considered to be Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) in the environment
• It has other intrinsic properties that give rise to concerns of effects to human health or the environment of a similar level of concern to substances that meet the first two criteria. The regulation gives, as an example, substances with endocrine disrupting properties.
A substance identified as SVHC is likely to follow the process that leads to Authorization
The timetable for this process will depend on ECHA's priorities that have regard to its properties, volumes and uses.
Occasionally ECHA will instead impose restrictions on the use of the substance. To date, it has only taken this course of action when the substance has adverse reproductive properties but test data demonstrates the existence of a "no effect" level. This is a level or concentration below which adverse effects do not occur.
The authorization process begins when the substance is proposed and included on the Candidate List :
A member state prepares an Annex XV dossier that proposes and justifies addition of the substance to the Candidate List. This is published on the ECHA website. Proposals are published twice per year, in April and October. There follows a 60 days opportunity to comment. In practice, only comments on intrinsic properties are taken into account and substances meeting the criteria are almost certain to be forwarded for inclusion on the Candidate List. It does, however, provide an opportunity to ensure that ECHA has up-to-date information on tonnages and uses.
We advise that companies that produce or import a substance that meets the criteria for an SVHC should regularly check the list. We also suggest checking the registry of intentions to discover if a member state intends to prepare an Annex XV dossier.
When a proposal is published, the process runs to a strict timetable for all parties involved (ECHA, member states and the Commission) and must be completed within 325 days.
Several obligations arise when a substance appears on the candidate list:
• Suppliers must update their Safety Data Sheets to advise their downstream users that the substance has been included on the Candidate List.
• Suppliers of articles containing the substance at levels >0.1% must advise downstream users that the article contains the substance and, if necessary, provide information on safe use. If the article contains the substance at a lower level, they must provide the same information on request.
• Producers or importers of articles containing the substance at levels >0.1% and in quantities totaling >1tpa must notify ECHA of the fact.
They are exempt from this requirement if there is no release of the substance at any point in the life cycle, including the waste stage. It is not necessary to inform ECHA but the decision should be documented and retained on file.
Adding a substance to the Candidate List also has a commercial impact. We advise that companies that use the substance should immediately contact their suppliers to confirm if it will continue to be available. We also advise them to investigate alternative substances in the event that it is selected for further investigation.
Substances on the Candidate List will be prioritized by ECHA for further attention. ECHA uses a scoring system to identify priority substances to take forward to the Authorization process. This takes into account the intrinsic hazard, the uses and the tonnage produced and imported. There is no time limit for a decision to proceed to the next stage of authorization.
Stage 2 of the process leading to Authorization starts with a further proposal being published for consultation on the ECHA website.
This starts another fixed timetable beginning with a public consultation that runs for 90 days for submissions by industry and other interested parties. This proposal will include the proposed phase out period (‘sunset dates’) for non-authorized uses and the date by which Authorization applications must be received (along with an application fee!). The publication will include uses exempt from authorization (if any) and review dates for authorized uses.
After the consultation window closes, the member states and Commission will consider the results of the consultation and to agree the final Annex XV entry. This should be completed 330 days after the close of the public consultation.
If you would like further information or guidance on what you should be doing, please contact us via our Contact page.