On 8 July 2021, the European Chemicals Agency (ECHA) added eight 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 219 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 face a significant undertaking to ensure regulatory compliance.
The eight new substances are:
- 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers.
- Orthoboric acid, sodium salt (13840-56-7).
- 2,2-bis(bromomethyl)propane1,3-diol (BMP); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA); 2,3-dibromo-1-propanol (2,3-DBPA).
- Glutaral (111-30-8).
- Medium-chain chlorinated paraffins (MCCP) (unknown or variable composition, complex reaction products (UVCB) substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17).
- Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP).
- 1,4-dioxane (123-91-1).
- 4,4'-(1-methylpropylidene)bisphenol (77-40-7).
Any manufacturers, importers or suppliers of articles with Candidate List substances that exceed a concentration of 0.1% (weight by weight) must submit notifications to the ECHA’s SCIP database within 6 months from inclusion of the SVHC onto 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:
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. This action may include inclusion onto the ECHA ‘Authorisation List’ followed by use restrictions. NCEC maintains an extensive database in conjunction with the ECHA lists – now updated with the newly added SVHCs on the Candidate List – and can offer tailored support and guidance for your product submissions. 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 help you make informed decisions to enable compliance with the ever-changing regulatory landscape. 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 or any other regulatory legislation, please do not hesitate to contact us using the form on the right hand side or email us at [email protected].
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