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On January 9, 2026, the European Commission released a draft regulation to amend Annex XVII of REACH Regulation (EC) No 1907/2006, introducing significant updates to restrictions on carcinogenic, mutagenic, and reprotoxic (CMR) substances available to the general public. The draft regulation is currently open for public feedback until February 6, 2026.
The proposed amendments respond to recent harmonized classifications established under the CLP Regulation (EC) No 1272/2008. Two Commission Delegated Regulations—(EU) 2024/2564 and (EU) 2025/1222—have introduced new harmonized classifications for substances as CMR categories 1A and 1B, necessitating corresponding updates to REACH restrictions.
Entries 28, 29, and 30 in Annex XVII currently prohibit the placing on the market and use of CMR category 1A and 1B substances for supply to the general public when concentrations meet or exceed specified limits.
Key Substances Added to Restriction Lists
The regulation adds multiple substances across different CMR categories:
Carcinogens Category 1A (Appendix 1):
Fluoroethylene (EC No. 200-832-6, CAS No. 75-02-5)
Carcinogens Category 1B (Appendix 2):
Multi-walled carbon nanotubes (MWC(N)T) with specific dimensional parameters
Acetone oxime (EC No. 204-820-1, CAS No. 127-06-0)
Benthiavalicarb-isopropyl (CAS No. 177406-68-7)
1,4-dichloro-2-nitrobenzene (EC No .201-923-3, CAS No. 89-61-2)
Trimethyl phosphate (EC No. 208-144-8, CAS No. 512-56-1)
Barium chromate (EC No. 233-660-5, CAS No. 10294-40-3)
1,1-dichloroethylene/vinylidene chloride (EC No. 200-864-0, CAS No. 75-35-4)
Germ Cell Mutagens Category 1B (Appendix 4):
N,N'-methylenediacrylamide (EC No. 203-750-9, CAS No. 110-26-9)
Trimethyl phosphate
Reproductive Toxicants Category 1B (Appendix 6):
Trimethyl borate (EC No. 204-468-9, CAS No. 121-43-7)
Multiple sodium perborate compounds with various hydration states
Reaction mass of 1,3-dioxan-5-ol and 1,3- dioxolan-4-ylmethanol
2-(dimethylamino)-2-[(4-methylphenyl) methyl]- 1-[4-(morpholin-4-yl)phenyl]butan-1-one (EC No. 438-340-0, CAS No. 119344-86-4)
Sodium 3-(allyloxy)-2- hydroxypropanesulphonate (EC No. 258-004-5, CAS No. 52556-42-0)
Tert-butyl 2-ethylperoxyhexanoate （EC No. 221-110-7, CAS No. 3006-82-4)
Dinitrogen oxide (EC No. 233-032-0, CAS No. 10024-97-2)
Trimethyl phosphate
2-bromo-3,3,3-trifluoroprop-1-ene (CAS No. 1514-82-5)
2,3-epoxypropyl isopropyl ether (EC No. 223-672-9, CAS No. 4016-14-2)
α,α'-propylenedinitrilodi-o-cresol (EC No. 202-374-2, CAS No. 94-91-7)
Specific esters, methacrylates, and sulfonated fatty acid salts (potassium)
Under Appendix 11, the regulation introduces a notable derogation for dinitrogen oxide, recognizing its authorized use as food additive E 942 under Regulation (EC) No. 1333/2008.
Permitted uses include:
Cartridges containing the substance (maximum 24 ml volume) for use as a food additive, with restrictions limiting sales to 120 ml total volume per individual per day, sales limited to individual 18 years or older.
Aerosol dispensers for food products where the substance serves as a propellant
Food products prepared with dinitrogen oxide as a food additive
The regulation will enter into force 20 days after publication in the Official Journal of the European Union. However, for substances classified under Delegated Regulation (EU) 2025/1222, it shall apply from February 1, 2027.
The draft regulation and its Annex can be accessed here.
