On 19 December 2012, the European Chemicals Agency (ECHA) updated the Candidate list with 54 substances of very high concern (SVHC). This results in a total of 138 identified SVHCs. The declared goal of the European Commission was to have 136 SVHCs on the list by end 2012. The number of substances added in 2012 was double the number added in the previous years.
Which substances can be identified as SVHCs?
Three types of substances can be added to the list:
- Carcinogens, mutagens, substances which are toxic for reproduction (CMRs) category 1A and 1B according to Regulation EC/1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation);
- Persistent, bioaccumulative and toxic substances (PBT), very persistent and very bioaccumulative substances (vPvB) in accordance with Annex XIII to the REACH Regulation; and
- Substances, identified on a case-by-case basis, for which there is scientific evidence of probable serious effects to human health or the environment (e.g. endocrine disruptors).
Detailed records have been submitted to add another 145 chemicals, and reports are being prepared for another 18 chemicals. It can be expected that ECHA will include 30 to 40 new SVHCs annually on the Candidate list, bringing the total number 10 around 500 substances by 2020.
Enhesa reviewed the 138 substances in function of their use in products. Paints and plastics are on top of the list with more than 40 substances each which can be found in them. For plastic articles the number even doubled. Next are electric equipment and metal articles with more than 25 substances. The following table 1 summarizes the results.
Table 1: Main Uses Impacted by Nr of Substances (28 Jun 2012 > 19 Dec 2012)
Obligations for companies triggered by the inclusion of a SVHC in the Candidate List
Industry should prepare timely to changes in the Candidate list, as it might also have an impact on its supply chain and the availability of some substances. Once a substance has been identified as SVHC and included in the Candidate list, it automatically triggers several information obligations for companies. There is no publication in the Official Journal of the European Union required.
1 Information obligations on SVHC
Suppliers of substances on the Candidate List have to provide their customers with a safety data sheet (SDS) from the date of the
inclusion of the substance in the list.
2 Information obligations on SVHC in mixtures
Suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet. This obligation applies if the mixtures contain at least one substance on the Candidate List and its individual concentration is at least 0.1% (w/w) for non-gaseous mixtures and at least 0.2% by volume for gaseous mixtures.
3 Information obligations on SVHC in articles
3.1 Information of Buyers
Suppliers of an article containing a substance included in the Candidate List of SVHC in a concentration above 0.1 % weight by weight (w/w) must provide the recipient of the article with sufficient information, available to the supplier, to allow the safe use of the article. This information must include, as a minimum, the name of that substance. There is no tonnage trigger for this obligation (this also applies below one metric ton/year) and there are no exemptions foreseen from this obligation for the reasons that exposure can be exempted (Article 7(3) of the REACH Regulation) or that the substance is already registered for this use (Article 7(6) of the REACH Regulation).
3.2 Consumer Requests
Upon request, suppliers have to provide information available to them that is necessary to ensure the safe use of an article. Suppliers must provide this information to consumers within 45 days of the request, and free of charge.
3.3 ECHA Notification
Producers or importers of articles must notify ECHA if their article contains a SVHC on the Candidate List in quantities totaling over one ton per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w). A notification is not required where the producer or importer of an article can exclude exposure of humans and the environment during the use and disposal of the article. However, the producer or importer must still supply appropriate instructions to the recipient of the article. Also, notification is not required where the substance has already been registered for that use. The notification needs to be made by 19 June 2013 for SVHC added to the list on 19 December 2012. On 1 September 2012, 219 notifications have been received related to 20 of the substances on the list (see Table 2).
Table 2: SVHC Notifications Received By ECHA
From the Candidate List to the Authorization List
Prepare for potential authorization if a substance cannot be phased out, once an SVHC from the Candidate list is added to the Authorization List. After the inclusion of a SVHC in the Candidate List, it might be prioritized for inclusion also into Annex XIV to the REACH Regulation (Authorization List). However, not all SVHC on the Candidate List will be included in the Authorization List. If a SVHC has been added to the Authorization List, companies have to apply for an authorization by the application date set for all uses not exempt from the authorization requirement.
The European Commission grants the authorization if the applicant can demonstrate that the risks from the use of the substance are adequately controlled, or that the socio-economic benefits outweigh the risks and that, no alternative substances or technologies are available. Downstream users can only use substances for authorized uses.
After the sunset date set in Annex XIV of the REACH Regulation, only companies holding an authorization can place on the market and/or use a substances included therein.
Enhesa Fact Sheet on SVHC
Enhesa maintains a Fact Sheet for industry of all SVHC on the Candidateand the Authorization List together withtheir uses.
You will find all relevant dates related to business'obligations with regard to the:
- Candidate List;
- Authorization List together with exemptions from the authorization requirement, if any;
- Main uses of SVHC grouped into industrial uses and article categories;
- An overview of Notifications on Use received thus far by ECHA;
- An overview of the number of SVHC added over time; and
- If you are looking for additional scientific information, we provide you the link to the relevant scientific dossiers which are available from the website of the European Chemicals Agency (ECHA).
The overview can be used by all actors inthe supply chain to identify at a glance the substances and products impacted by the Candidate and Authorization List. Interested to get the full overview? Contact Enhesa at mailto:firstname.lastname@example.org?subject=”SVHC Fact Sheet (SAP Community)” for a copy of the SVHC Fact Sheet.