The European Commission has published a draft proposal to amend Annex XVII of the EU REACH Regulation (EC) No 1907/2006, aiming to align existing restriction entries with new harmonised hazard classifications introduced under the EU Classification, Labelling and Packaging (CLP) Regulation in 2024 and 2025.
The proposed amendment focuses on expanding controls for Carcinogenic, Mutagenic, and Toxic for Reproduction (CMR) substances, reinforcing the EU’s long-standing objective of minimising human exposure to substances of very high concern, particularly in consumer and professional applications.
Under the EU chemicals framework, substances classified as CMR Category 1A or 1B under CLP are typically considered for restriction under REACH Annex XVII, especially where risks to human health cannot be sufficiently controlled through other regulatory measures.
Expansion of CMR Lists under Draft REACH Annex XVII Update
The draft amendment proposes to add and update several CMR substances across multiple hazard categories to ensure Annex XVII reflects the latest scientific and toxicological assessments.
| CMR Category | Hazard Classification | Substance Name | EC No. | CAS No. | Notes |
|---|---|---|---|---|---|
| Carcinogenic | Category 1A | Vinyl fluoride | 200-832-6 | 75-02-5 | Newly classified under CLP; proposed for Annex XVII alignment |
| Carcinogenic | Category 1B | Multi-walled carbon tubes / carbon nanotubes | — | — | Applies to specific size and shape criteria |
| Carcinogenic | Category 1B | Acetone oxime | 204-820-1 | 127-06-0 | Industrial intermediate |
| Carcinogenic | Category 1B | Benthiavalicarb-isopropyl | — | 177406-68-7 | Mainly used as a fungicide |
| Carcinogenic | Category 1B | 1,4-Dichloro-2-nitrobenzene | 201-923-3 | 89-61-2 | Chemical intermediate |
| Carcinogenic | Category 1B | Trimethyl phosphate | 208-144-8 | 512-56-1 | Also classified under mutagenicity |
| Carcinogenic | Category 1B | Barium chromate | 233-660-5 | 10294-40-3 | Chromium-containing compound |
| Carcinogenic | Category 1B | 1,1-Dichloroethylene (Vinylidene chloride) | 200-864-0 | 75-35-4 | Used in polymer production |
| Mutagenic | Category 1B | N,N′-Methylenediacrylamide | 203-750-9 | 110-26-9 | Cross-linking agent |
| Mutagenic | Category 1B | Trimethyl phosphate | 208-144-8 | 512-56-1 | Dual CMR classification |
| Reprotoxic | Category 1B | Trimethyl borate | 204-468-9 | 121-43-7 | Boron compound |
| Reprotoxic | Category 1B | Perboric acid & related borate salts | — | — | Group entry covering multiple substances |
Purpose and Regulatory Context
The proposal is technical and alignment-driven, rather than a standalone risk-management restriction. Its objectives are to:
- Synchronise REACH Annex XVII with updated CLP classifications
- Ensure newly classified CMR 1A and 1B substances are adequately regulated
- Maintain a high and consistent level of protection for workers, consumers, and vulnerable populations
Next Steps and Timeline
- The draft amendment is currently open for public consultation
- The Commission may revise the proposal following stakeholder feedback
- Once adopted, it will be published in the Official Journal of the EU
- Entry into force: 20 days after publication
- Application dates: May vary by substance, allowing transition periods where necessary
Implications for Industry
If adopted, companies may face significant compliance impacts, including:
- New placing-on-the-market restrictions
- Non-compliance risks for mixtures and articles exceeding concentration limits
- Increased need for reformulation, substitution, and risk assessment
- Enhanced supply-chain communication, including SDS updates
Early portfolio screening and proactive compliance planning will be critical to minimise regulatory and business risks.
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