2025-01-28 - Five Substances Added and an Update to EU REACH SVHC List - CDX Web
News
The European Chemicals Agency (ECHA) has recently expanded the Substances of Very High Concern (SVHC) Candidate List under the EU REACH Regulation. This update includes the addition of five new substances and a modification to an existing entry, bringing the total number of entries on the EU REACH SVHC Candidate List to 247. Importantly, the Compliance Data Exchange (CDX) system has been updated to reflect these latest additions to the ECHA Candidate List of Substances of Very High Concern (SVHC).
The following five substances have been added to the SVHC Candidate List:
| Substance Name | EC Number | CAS Number | Reason for Proposing | Examples of Uses |
|---|---|---|---|---|
| 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid | 701-118-1 | 2156592-54-8 | Toxic for reproduction (Article 57c) | Lubricants, greases, release products and metal working fluids |
| O,O,O-triphenyl phosphorothioate | 209-909-9 | 597-82-0 | Persistent, bioaccumulative and toxic, PBT (Article 57d) | Lubricants and greases |
| Octamethyltrisiloxane | 203-497-4 | 107-51-7 | Very persistent, very bioaccumulative, vPvB (Article 57e) | Manufacture and/or formulation of: cosmetics, personal/health care products, pharmaceuticals, washing and cleaning products, coating and non-metal surface treatment and in sealants and adhesives |
| Perfluamine | 206-420-2 | 338-83-0 | Very persistent, very bioaccumulative, vPvB (Article 57e) | Manufacture of electrical, electronic and optical equipment and machinery and vehicles |
| Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives | 421-820-9 | 192268-65-8 | Persistent, bioaccumulative and toxic, PBT (Article 57d) | Additives in lubricants and hydraulic fluids |
The following existing entry on the SVHC Candidate List has been updated:
| Substance Name | EC Number | CAS Number | Reason for Proposing | Examples of Uses |
|---|---|---|---|---|
| Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) | - | - | Endocrine disrupting properties (Article 57(f) – environment) | Polymers, adhesives, sealants and coatings |
Implications for Companies
The inclusion of these substances in the SVHC Candidate List and their addition to the CDX system have immediate consequences for companies:
- CDX System Update: The CDX system now includes these new substances for data collection and analysis purposes.
- Customer Notification: Companies must inform their customers about the presence of these substances in their products above the 0.1% weight by weight threshold.
- SCIP Database Submissions: Notifications to ECHA through submissions to the SCIP Database are required.
- Supply Chain Communication: Suppliers must provide information on safe use to their customers.
- REACH Obligations Review: Companies using these substances in their products or supply chains must review their obligations under the REACH regulation.
- Safety Data Sheet Updates: Safety Data Sheets for mixtures containing these substances should be updated accordingly.
Next Steps for CDX Users
To ensure compliance with the updated SVHC list, CDX users should:
- Review existing Material Data Sheets (MDS), especially those with Full Material Disclosure (FMD), to verify the presence of the newly added substances.
- For products without FMD, contact suppliers to confirm whether articles provided contain any of the new substances above 0.1% weight by weight.
- Update product information and notifications in the CDX system as necessary.
Companies are advised to stay informed about regulatory updates and take necessary actions to maintain compliance and product safety. The CDX Team remains committed to enhancing the system to meet evolving regulatory requirements and will continue to provide updates to support comprehensive compliance solutions for users.