On 17 January 2022, the European Chemicals Agency (ECHA) added four new substances of very high concern (SVHC) to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation Candidate List. The Candidate List now contains 223 SVHCs due to their effects on humans and the environment.
With these additional SVHCs added to the Candidate List, companies that are manufacturing or importing products in the EU now have a legal obligation to ensure that none of their mixtures, articles or substances contain items included on the List. Any organisation that was previously not obligated to submit ‘Substances of Concern In articles, as such or in complex objects (Products)’ (SCIP) notifications, now potentially faces a significant undertaking to ensure regulatory compliance.
The four new substances are:
- 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol (CAS: 119-47-1)
- tris(2-methoxyethoxy)vinylsilane (CAS: 1067-53-4)
- (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC) (CAS: N/A)
- S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate (CAS: 255881-94-8)
What should organisations do if they use an SVHC on the Candidate List?
If your mixture contains any of the SVHCs present on the Candidate List in more than 1% weight by weight (w/w) (or 0.1 w/w% on request, including if the overall mixture is non-hazardous), you need to update your safety data sheets (SDS). If you need any help with SDS authoring to maintain compliance, get in touch with us or visit here for more information.
Any manufacturers, importers or suppliers of articles with Candidate List substances that exceed a concentration of 0.1 w/w% must submit notifications to the ECHA’s SCIP database within six months from inclusion of the SVHC on to the List. Suppliers have the additional responsibility of providing sufficient information to their customers and consumers to allow safe use of their articles that contain a SVHC.
Companies should be ready to submit the following information:
- Substance identifiers.
- Name, concentration and location of the SVHC in the article.
- Safe-use information for the articles.
- Waste management advice according to the requirements for SCIP notifications, which was published in October 2020.
How can NCEC help?
The SCIP database is proving to be an unpredictable and complex legal requirement. Substances currently on the Candidate List are subject to assessment and review to establish appropriate future action, which may include inclusion on the ECHA ‘Authorisation List’ followed by use restrictions.
NCEC’s horizon scanning and compliance reporting service can identify whether your substances appear on any of relevant regulatory lists, including, but not limited to, the five REACH Lists, and provides the results in a clear, easy-to-read report. We have an extensive and regularly updated database that is used to monitor the status of your product portfolio, providing you with the most recent developments regarding your substances and enabling your company to become fully compliant. A check against our database can help you better understand the composition of your products and enable you to be ready to submit your notifications.
Our regulatory team can support your organisation to make informed decisions to enable compliance with continual changing regulations. Our in-depth knowledge of the global supply chain means we are ideally placed to assist you in understanding your obligations worldwide and prepare for any future changes.
If you require any further assistance regarding the SCIP database, how to make submissions to this database, need more information on how we can assist you in monitoring your product portfolio across various databases or have any other regulatory enquiry, contact us using the form on the right or email us at [email protected].
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