On December 5, 2024, the European Commission revised the Carcinogenic, Mutagenic, or toxic to Reproduction (CMR) substances list within REACH's Annex XVII (Regulation (EC) No 1907/2006), introducing three key changes.
- Public Sale and Use Restrictions: The updated regulation strictly bans the public sale and use of Category 1A or 1B carcinogens, germ cell mutagens, or reproductive toxins, as detailed in Articles 28, 29, and 30 of Regulations (EC) No 1272/2008 and 1907/2006. It also imposes stringent controls on the concentration of these substances in mixtures.
- Annex XVII Appendices Expansion: The regulation adds substances to Appendices 2, 4, and 6 of Annex XVII, reflecting the inclusion of newly classified Category 1B CMR substances.
- Isopropylbenzene Use Exemptions: According to Regulation (EU) 2023/1132, from December 1, 2023, isopropylbenzene is not to be marketed or used in aviation fuel at concentrations of 0.1% w/w or higher for non-professional pilots. However, this does not apply to automotive fuel for non-professional drivers. Given the similarities between non-professional drivers and small aircraft pilots, and the fewer number of the latter, isopropylbenzene in aviation fuel is exempt from restrictions in Articles 28, 29, and 30 of Annex XVII to Regulation (EC) No 1907/2006.
These changes will become effective 20 days after publication and will be fully implemented by September 1, 2025. Despite the formal enforcement of the new Category 1B CMR substances provisions starting from September 1, 2025, the European Union urges operators to act proactively.
Annex XVII is amended as follows:
The following substances are to be incorporated into Appendix 2.
| Substances | Index No | EC No | CAS No |
| ‘diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea | 006-015-00-9 | 206-354-4 | 330-54-1’ |
| ‘2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A | 604-074-00-0 | 201-236-9 | 79-94-7’ |
| ‘N,N-dimethyl-p-toluidine | 612-296-00-4 | 202-805-4 | 99-97-8’ |
| ‘4-nitrosomorpholine | 613-346-00-8 | - | 59-89-2’ |
| ‘4-methylimidazole | 613-349-00-4 | 212-497-3 | 822-36-6’ |
The following substance is to be incorporated into Appendix 4.
| Substance | Index No | EC No | CAS No |
| ‘dimethyl propylphosphonate | 015-208-00-7 | 242-555-3 | 18755-43-6’ |
The following substances are to be incorporated into Appendix 6.
| Substances | Index No | EC No | CAS No |
| ‘diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide | 015-203-00-X | 278-355-8 | 75980-60-8’ |
| ‘benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate | 015-204-00-5 | 479-100-5 | 577705-90-9’ |
| ‘benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) | 015-205-00-0 | 278-305-5 | 75768-65-9’ |
| ‘reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1) | 015-206-00-6 | - | -’ |
| ‘dimethyl propylphosphonate | 015-208-00-7 | 242-555-3 | 18755-43-6’ |
| ‘dibutyltin maleate | 050-034-00-5 | 201-077-5 | 78-04-6’ |
| ‘dibutyltin oxide | 050-035-00-0 | 212-449-1 | 818-08-6’ |
| ‘reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane | 603-244-00-1 | - | -’ |
| ‘4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF | 604-099-00-7 | 216-036-7 | 1478-61-1’ |
| ‘1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.; | 612-298-00-5 | 273-227-8 | 68953-84-4’ |
| ‘4-methylimidazole | 613-349-00-4 | 212-497-3 | 822-36-6’ |
The following substances are to be incorporated into Appendix 11.
| Substances | Derogations |
|
‘2. Cumene CAS No 98-82-8 EC No 202-704-5 |
As a substance on its own or as a constituent of other substances in either of the following:
|
You can freely access the EU CMR substances list via the provided link on ChemRadar through
https://www.chemradar.com/tools/cis/inv/6593b44205b53d5bc391a5c8?utm_medium=gcis&utm_campaign=cis
