SVHC stands for 'Substance of Very High Concern'
In general terms an SVHC is a substance meeting one or more of the following criteria:
Note that there are over 1000 substances that potentially fulfil these criteria. However...
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 authorisation.
It is inclusion of substances in the 'Candidate List' that triggers additional duties for manufacturers, importers and users. Currently containing 173 substances, the list will continue to be regularly updated, and is expected to ultimately grow to around 400 substances. REACH imposes specific controls on SVHCs over and above those that apply to other chemicals.
Communicating information on SVHCs in articles
Any supplier* of an article containing a SVHC on the 'Candidate List' in a concentration above 0.1 % (w/w) has the duty to provide the recipient of the article with sufficient information to allow safe use of the article. This information also needs to be provided to consumers within 45 days of a request.
*Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain (e.g. a retailer) placing an article on the market.
Notifying the ECHA of SVHCs in articles
Producers and importers of articles may have to notify the ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present above 0.1% (w/w) and its quantities in the produced/imported articles are above 1 tonne in total per year per company. If you import or produce several articles containing the same SVHC you need to consider the total tonnage, which is calculated by adding the tonnages of the substance for each article that contains the substance at 0.1% (w/w) or higher.
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.
Any company supplying "articles" is affected by REACH. This includes retailers, manufacturers and distributors of consumer products and suppliers of parts/components to these markets. Examples of market affected are retail, automotive, electronics, white goods, etc.
The major issue for these "article suppliers" is how to determine whether any of the Candidate List SVHCs are present in their products and at what level. This task is made more difficult by the continuous expansion of the Candidate List. SVHCs have been shown to be contained in a range of consumer products, including shoes, clothing, toys, electronics etc., but manufacturers and retailers are not always aware of their presence. If you want to find out how your products might be affected, and what the likelihood is of them containing any of the current or proposed SVHCs, The REACH Centre can help. Our Business Impact Assessment can help you get to grips with the regulation and prepare your compliance action plan. You may also need to test some of your products for presence of SVHCs. The REACH Centre offers a high quality Testing Service with free testing strategy advice. For more on these services click here.
What substances are on the Candidate List? Currently there are 173 substances, but their number will increase over time. To help you keep track of the Candidate List, the table below show an up-to-date list of substances included. To ensure you get the latest regulatory updates including new SVHCs on the Candidate List direct to your email, why not sign up for our free Chemtrac alerts by filling in the signup box on the left?
Total 173 substances, last update 12 January 2017
Member States or the Commission can nominate a substance for inclusion in the Candidate List by submitting an Annex XV dossier. After a 45-day consultation period during which interested parties can comment on the dossiers, the proposed SVHCs go through a final procedure whereby the Member States and the Commission decide on whether to include them on the Candidate List. The table below shows an up-to-date list of substances which are currently under consultation.
Before submission of the Annex XV dossier, the substance is notified to the Registry of Intentions in order to give companies advance warning of the possible inclusion of the new substance on the Candidate List.
The table below shows which substances are currently on the Registry of Intentions.
Having advance warning of proposed new SVHCs will allow your company to prepare for Candidate List updates and associated obligations.