What is SVHC?
According to EU REACH regulation, substances that may have serious and often irreversible effects on human health and the environment can be identified as Substances of Very High Concern (SVHCs). If a substance is identified as SVHC, it will be added to the Candidate List for eventual inclusion in the Authorisation List.
To be identified as an SVHC, a substance needs to fulfil one or more of the following criteria:
1. Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B.
2. Substances that are persistent, bioaccumulative and toxic (PBTs).
3. Substances that are very persistent and very bioaccumulative (vPvBs).
4. Substances for which there is scientific evidence of probable serious effects on human health or the environment, such as endocrine disruptors.
In general, the Candidate List is updated twice a year (usually in June and December each year). There are 205 substances on the Candidate List (last updated: 25 February 2020), you can find the full list on ECHA’s website: https://echa.europa.eu/candidate-list-table
Obligation of SVHC
Companies may have legal obligations resulting from the inclusion of substances in the Candidate List. These obligations, which are effective from the date of inclusion, refer not only to the listed substances on their own or in mixtures but also to their presence in articles.
• Safety Data Sheet for substances on their own and substances in mixtures
• Notification to ECHA for SVHC in articles
• Duty to communicate safe use information or respond to customer requests
Notification of SVHC in Articles
Producers and importers have to notify to ECHA the substances listed on the Candidate List which are present in their articles, if both the following conditions are met:
• The substance is present in their relevant articles above a concentration of 0.1% weight by weight.
• The substance is present in these relevant articles in quantities totalling over one tonne per year.
Exemptions: There are two cases where notification is not required.
• The producer or importer of an article can exclude the exposure of humans and the environment to the substance during normal or reasonably foreseeable conditions of use of the article, including its disposal. In these cases, the producers and importers will give appropriate instructions to the recipient of the article.
• The substance has already been registered by a manufacturer or importer in the EU for that use.
Deadline: Companies have to notify no later than six months after the inclusion of the substance in the Candidate List.
• One notification should concern one substance on the Candidate List. If articles contain more than one of the Candidate List substances, you need to submit a separate notification for each substance. If several articles contain the same substance, you need to include them all in one notification.
• Once an article, always an article. The 0.1% trigger limit applies to each article within an assembled object or complex object.
• Prepare the notification dossier including substance identification, classification, tonnage, use information, etc., and submit it to ECHA via REACH-IT.
• Non-EU producers of articles can appoint Only Representatives to fulfil all REACH obligations of the importers of their articles in the EU.
Communication in the Supply Chain
Directly after a substance is included in the Candidate List, suppliers of articles that contain such a substance in a concentration above 0.1% have to inform their customers:
• Applies to all suppliers of articles that contain more than 0.1% of any substance on the Candidate List;
• Requires the supplier to provide recipients of the article with sufficient information to allow safe use of the article. As a minimum, the name of the substance has to be provided;
• Requires the supplier to provide such information to consumers on request, within 45 days from the date of the request, free of charge.
• Only Representative (OR) Service
• EU REACH Compliance Service for Consumer Articles
• Registration Service for Intentionally Released Substances in Articles
• Notification of SVHC to ECHA
• SVHC Assessment Report/ SVHC Compliance Report
• SDS and Label Service
• Training and Consultation