In general terms, Substances of very high concern (SVHC) are substances that have hazards with serious consequences, e.g. They cause cancer, or they have other hazardous properties and/or remain in the environment for a long time with their amounts in animals gradually building up.
SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 (“the REACH Regulation”) and include substances which are:
- CMR (Carcinogenic, Mutagenic or toxic to Reproduction) -substances meeting the criteria for classification as carcinogenic. Mutagenic or as toxic to reproduction category 1 or 2 in accordance with Directive 67/548/
- PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative) – substances which are persistent. Bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII REACH Regulation
- Substances with scientific evidence of harm to humans or the environment. These include endocrine disruptors, persistent toxic substances, and those not meeting Annex XIII criteria.
The identification of substances as Substances of Very High Concern and its inclusion in the Candidate List, published on ECHA web site, is the first step in the procedure concerning authorisation.
Companies have legal obligations resulting from the inclusion of the substances in the Candidate List from the date of inclusion:
® For substance – From 28 October 2008, EU & EEA suppliers of a substance have to provide a safety data sheet to their customers when the substance is on the Candidate
® For preparations – From October 28, 2008, EU and EEA suppliers must provide safety data sheets, on request, for preparations not classified as dangerous under Directive 1999/45/EC. This applies if the preparation contains at least one substance from the Candidate List, with an individual concentration of at least 0.1% (w/w) for non-gaseous preparations and 0.2% by volume for gaseous preparations.
® For articles – From 28 October 2008, EU & EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) must provide sufficient information, available to them, to their customers and on request to a consumer within 45 days of the receipt of this request. This information must ensure safe use of the article and, as a minimum, include the name of the substance.
– From 1 June 2011, EU and EEA producers or importers of articles have to notify ECHA. If their article contains a substance on the Candidate List. This rule is relevant when the substance exceeds 0.1% (w/w) and annual article quantities surpass 1 tonne per company.
As a second step, ECHA has to prepare for each prioritised substance a draft recommendation for inclusion in Annex XIV. (Authorisation List) specifying the date from which the use of the substance is prohibited unless an authorisation is granted. (i.e. the “Sunset Date”). The application date by which applications for authorisation must be received and uses or categories of uses exempted from the authorisation requirement if any. Decisions to include substances in Annex XIV will be based upon recommendations from ECHA, taking into account the opinion of the Member State Committee.
How to comply with the obligations for substances listed in candidate list for the products?
From 28 October 2008, EU & EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) must provide sufficient information, available to them, to their customers and on request to a consumer within 45 days of the receipt of this request. This information must ensure safe use of the article and, as a minimum, include the name of the substance.
From 1 June 2011, EU and EEA producers or importers of articles have to notify 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.
Important points to Article 33
- Obligations under Article 33 are determined according to annual production volume of substance unlike the obligations for substances listed in the candidate list according to article 7.2 (notification)
- Responsibilities to provide information is for all links in the supply chain not just the manufacturer and importer as in the case of notification)
- The obligation to inform recipients begins when ECHA publishes a candidate list of highly concerning substances on its website.
- Article 33 pertains to items made or brought in post-listing, and extends to pre-listing items in stock at suppliers.
How you can obtain information?
Article suppliers will be obliged to determine Candidate list substances in articles, as per Article 33. Typically, manufacturers are aware of their articles’ composition. However, this doesn’t necessarily imply knowledge of detailed substance and preparation composition in the articles they sell. MSDS contain information about the presence of substances which are already classified as dangerous, but not the exact concentrations of the substances. Relevant information can be gathered by up and down communicating trough the supply chain.
Communication up the supply chain
To meet the articles supplier’s obligations under article 33 they will have to actively ask their suppliers /manufacturers for information.
Some of the options are below:
- They will monitor all update the candidate list and every time request the supplier /manufacturer for information about new substances published in the candidate list.
- Request the supplier to monitor all update of candidate list and ask the supplier for the information in the case of positive findings
- Ask the supplier for detailed composition of substance and preparation in articles
- Provide tests to detect substances in the candidate list, though it takes time for chemical analysis.
Communication down the supply chain
Suppliers must inform recipients about substances from the candidate list if they exceed 0.1% w/w in the article.
Below are some of the main ways how to communicate information down the supply chain:
- Follow update the candidate list and each change communicate with customers. (Whether products contain or not the substance of very high concern listed in candidate listed list)
- Proactively notify customers about ongoing candidate list updates, promptly sharing new information when it’s available.
- Answer all customer questions on request.
Article 33.2. Request suppliers with candidate list substances to provide free, requested article information within 45 days to customers.
Some important information to this article:
- Obligation to respond to consumer demand to products supplied after the publication of the list.
- Suppliers who furnish items post-list publication must respond to consumer requests.
- Customers who received the product can ask the supplier for information; others cannot make the request.
- In articles tied to batch numbers, precision is vital to avoid inaccuracies; provide exact indications for clarity.