The first of two biannual updates to the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation was issued on January 17, expanding the Candidate List of substances of very high concern (SVHCs) with four new substances.
Companies manufacturing, importing, or distributing in the EU have a duty to communicate the presence of any listed SVHC above the 0.1 percent weight over weight (w/w) threshold to downstream consumers. Substances on the Candidate List may be selected for further restriction by the European Chemicals Agency (ECHA).
New REACH Compliance SVHCs
The four new SVHCs for REACH compliance are:
- 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol (DBMC) (EC: 204-327-1, CAS: 119-47-1)
- tris(2-methoxyethoxy)vinylsilane (EC: 213-934-0, CAS: 1067-53-4)
- 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 (DPM) (EC: 401-850-9, CAS: 255881-94-8)
- (±)-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). A full listing of all specific substances (individual CAS numbers) within this Substance Group can be obtained by looking up the current REACH Candidate List.
The inclusion of both DBMC and DPM has potentially significant impacts for complex manufacturers due to their widespread use as lubricants, adhesives, and greases. The substance tris(2-methoxyethoxy)vinylsilane is also used in manufacturing to make rubbers, plastics, or sealants, but is likely less widely used than DBMC and DPM. Used in cosmetics, 4-MBC may also be a concern for some companies.
Know your requirements and stay ahead of penalties, lost market access, and reputational damage caused by non-compliance. Download our eBook, The REACH Handbook: Your Guide to SVHC Compliance.
REACH Consequences for Companies
Companies in scope of the REACH Regulation must now examine their supply chains for these substances. The presence of any SVHC in an article, either on its own or in a mixture, will trigger obligations to communicate with downstream consumers and provide instructions for the safe use of the product.
Manufacturers and importers of articles have six months from the date of the announcement (July 17, 2022) to meet their obligations.
The REACH Regulation isn’t the only hurdle companies will have to clear. The EU Waste Framework Directive requires companies doing business in the EU to submit complex dossiers to the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database when their products contain SVHCs. The new substances will require either new dossiers for the database or the revision of existing dossiers for parts containing the substance.
Future REACH Compliance Expansion
The REACH Regulation will expand again, likely in July. One substance that may be in the next batch of SVHCs is resorcinol (EC: 203-585-2, CAS: 108-46-3). The substance, used frequently as a partner in resins, received much debate, but didn’t make the final list.
There’s a significant political and social push to manufacture safer products by eliminating substances known to cause environmental harm or damage human health. A recent European Chemicals Agency (ECHA) enforcement study found almost 80 percent of checked products didn’t meet REACH requirements. The investigation resulted in over 5,000 enforcement actions.
How Assent Helps With REACH Compliance
Compliance with REACH, SCIP database obligations, and other product compliance legislation in the EU requires a deep view of your manufacturing process. Assent helps complex manufacturers continuously map their supply chain so they can identify what parts and subparts need attention and can take action sooner. Faster action means less risk and happier customers.
Assent’s REACH solution updates automatically alongside the regulation, so manufacturers can have confidence their programs remain up to date. Assent’s platform is powered by people, including a global team of regulatory experts who are on hand to answer questions and help focus programs. You can read more about our REACH solution here. If you have any questions, please contact our experts.
