Substances of Very High Concern (SVHC)
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 for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfill the criteria set out in Annex XIII REACH Regulation
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 28 October 2008, EU and EEA suppliers of a preparation not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the preparation contains at least one substance on the Candidate List and its individual concentration is at least 0.1% (w/w) for non gaseous preparations and at least 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 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.
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
Þ 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)
Þ Obligations to provide information is for all links in the supply chain not just the manufacturer and importer as in the case of notification)
Þ Obligation to provide information to the recipient for the articles start as soon as it is on the ECHA website is published a candidate list of substances of very high concern
Þ Article 33 applies only to articles manufactured or imported after the publication of the candidate list, but also to those produced or imported before that date and are kept in stock at the supplier at the time of publication of the list.
How you can obtain information?
Article suppliers will be obliged for Candidate list substances determination in articles according to article 33. Usually the manufacturer know what they articles are composed from. This does not necessarily mean that they know the detailed composition of substances and preparations in the articles they sell. SMDS 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 test for the presence of the substances listed in the candidate list (disadvantage is the time required chemical analysis)
Communication down the supply chain
The suppliers of article will have to inform also the recipients about substances from the candidate list of more than 0.1% w/w. contain in 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
- Actively inform customers that your company monitor updates the candidate list and you will inform them as soon as you get available information
- Answer all customer questions on request
Article 33.2 ask for that any supplier of the articles containing the substance from the candidate list have to provide to customers on their request sufficient information of the article free of charge within 45 days.
Some important information to this article:
- Obligation to respond to consumer demand to products supplied after the publication of the list
- Only those suppliers who supply the articles after publication of the list are required to respond to consumer request.
- Only customers to whom the product has been supplied can request the supplier for information
- For articles where the composition is dependent on the batch number is necessary to provide a precise indication of the article to avoid providing inaccurate information