In August 2024, the European Chemicals Agency (ECHA) launched a public consultation on a proposal to add six new substances to the Substances of Very High Concern (SVHC) Candidate List under the EU REACH Regulation. If approved, the number of entries on the Candidate List would reach 247, increasing obligations for affected industries. The consultation, published on August 30, 2024, remains open for comments until October 14, 2024.
Current Status of the SVHC List:
As of June 27, 2024, the REACH SVHC Candidate List contains 241 entries. Inclusion of new substances places immediate regulatory responsibilities on companies that use these substances in their products above the specified thresholds. These obligations include customer notifications and required submissions to the SCIP (Substances of Concern in Products) Database.
Newly Proposed SVHCs and Their Properties:
ECHA’s proposal includes six substances, flagged for their potentially hazardous characteristics, including reproductive toxicity, persistence, bioaccumulation, toxicity (PBT), very persistent, very bioaccumulative (vPvB) properties, and endocrine-disrupting effects.
These substances are:
- 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
- O,O,O-triphenyl phosphorothioate
- Octamethyltrisiloxane
- Perfluamine
- Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives
- Tris(4-nonylphenyl, branched and linear) phosphite
The Impact of New SVHC Inclusions:
If a substance is officially identified as an SVHC, it is added to the Candidate List, which serves as a stepping stone to possible inclusion on the Authorisation List. When a substance is on the Authorisation List, companies must seek authorisation from the European Commission for continued use; otherwise, its use is restricted or prohibited.
Immediate Obligations for Companies:
For suppliers, the addition of new SVHCs triggers several requirements:
- Customer Notifications: Suppliers of articles containing more than 0.1% (weight by weight) of an SVHC must inform their customers and consumers, providing safety information and a safety data sheet.
- SCIP Database Submissions: Importers and manufacturers of articles must notify ECHA within six months if their products contain a Candidate List substance.
Benefits of Compliance:
Identifying and addressing SVHCs helps companies proactively manage potential risks associated with hazardous substances, aligning with EU’s stringent environmental and public health standards. Proactive compliance not only supports legal requirements but also bolsters customer trust and brand reputation, as consumers increasingly prioritize sustainable, safe products.
Compliance XL provides comprehensive consulting services for REACH compliance, including support with REACH declarations and SVHC data management. Our services include maintaining supplier certificates and declarations to ensure up-to-date compliance records, simplifying the ongoing obligations companies face as they adapt to regulatory updates.
As the regulatory landscape evolves, understanding and adhering to REACH requirements is essential. Compliance XL is committed to helping companies stay ahead of regulatory changes, ensuring smooth operations and compliance. Reach out to learn how we can assist with your REACH compliance strategy and data management needs.
FAQs:
1.Who needs to comply with REACH?
Companies or individuals that import, manufacture, use or place substances, mixtures or articles on the EU market must be compliant with the REACH regulation.
2.How can companies ensure compliance with REACH?
Companies can ensure compliance by registering their substances with ECHA, maintaining up to date SDS, keeping detailed records, and staying informed about regulatory changes.
