Substances on the market may present a danger to human health and the environment. Regulatory agencies evaluate substances and identify if they are a risk. In some cases, placing substances onto the REACH Candidate List for Substances of Very High Concern (SVHC) for Authorisation is necessary. Once on the Candidate List, actors in the market must comply with specific regulatory obligations.
Substances that meet the following criteria may be added to the candidate list:
- Classification in the hazard class carcinogenicity category 1A or 1B;
- Classification in the hazard class germ cell mutagenicity category 1A or 1B;
- Classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development;
- Persistent, bioaccumulative and toxic (PBT);
- Very persistent and very bioaccumulative (vPvB); and
- Substances 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 fulfil the criteria of points above.
Process for adding substances to the Candidate List
- Member States or ECHA inform interested parties of their intention to propose a substance for identification as an SVHC
- The intention is published in the registry of intentions, on ECHA’s website
- The Member State or ECHA prepares an SVHC dossier in accordance with Annex XV
- The Annex XV dossier is submitted to ECHA
- ECHA assesses the dossier according to Annex XV
- If the dossier passes the accordance check it will be published on ECHA’s website
- Interested parties are invited to submit comments during a 45 day consultation period
- If no comments are received then the substance is included directly on the Candidate List
- If comments challenge the Annex XV proposal then the information is referred to the Member State Committee (MSC) for review
- If the MSC does not reach an unanimous agreement then the matter is referred to the European Commission for final decision
- Defra Secretary of State, Welsh ministers, Scottish ministers and Health and Safety Executive (HSE) put a substance forward for inclusion on the Candidate List
- HSE prepare a dossier on, and consult on, the proposed addition to the Candidate List
- HSE (with the Environment Agency (EA) advising on environmental matters) decide on whether to add a substance to the Candidate List
Requirements for substances on the candidate list
Adding a substance to the Candidate List triggers new compliance requirements for duty holders that import and supply substances, mixtures and articles.
Substances and mixtures
- Suppliers of substances on the Candidate List, either on their own or in mixtures, must provide a safety data sheet (SDS) [REACH Article 31(1)].
- Importers of articles containing an SVHC in concentrations greater than 0.1% w/w (weight by weight), and the total imported volume of the SVHC exceeds 1 ton per year, must notify the Agency. This notification must be made within 6 months of the substance being added to the candidate list [REACH Article 7(2)].
- Suppliers of articles to professionals that contain an SVHC in concentrations greater than 0.1% w/w must inform the recipient with the substance name, at the very least [REACH Article 33(1)].
- Suppliers of articles to consumers that contain an SVHC in concentrations greater than 0.1% w/w must respond within 45 days of a request [REACH Article 33(2)].
- European Economic Area only – Importers and producers of articles must notify ECHA if their products contain substances of very high concern in a concentration above 0.1 % w/ [Waste Framework Directive]. This information will then be added to the Substances of Concern in Products (SCIP) database.
What about REACH authorisation?
SVHCs are candidates for the REACH authorisation list. Substances on the authorisation list cannot be used or placed on the market after the sunset date unless an authorisation is granted by the European Commission or an exemption applies. Although it is named the Candidate List for Substances of Very High Concern (SVHC) for Authorisation, not all substances placed on the Candidate List will end up on the authorisation list.
How to manage obligations and risks
- Monitor changes to the Candidate List (EU REACH and UK REACH);
- Identify if SVHCs are contained within in your products;
- If so, determine and complete all compliance actions; and
- Prepare to take further action if the substance is added to the authorisation list.
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