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On December 5, 2024, European Commission released a draft act to introduce several carcinogenic, germ cell mutagenic, or reproductive toxic (CMR) substances under Annex XVII to Regulation (EC) No 1907/2006.
Under EU REACH, entries 28, 29 and 30 of Annex XVII (Restriction List) has prohibited the placing on the market and use, for supply to the general public, of substances that are classified as CMR categories 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP Regulation).
This amendment aligns with the new classification of substances as CMR in Regulation (EC) No 1272/2008 as amended by Commission Delegated Regulation (EU) 2024/197.
Therefore, Appendices 2, 4 and 6 to Annex XVII are proposed to be amended as follows:
1. In Appendix 2, the following entries are inserted:
| Substances | Indenx 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 |
2. In Appendix 4, the following entries are inserted:
| Substances | Indenx No. | EC No. | CAS No. |
| dimethyl propylphosphonate | 015-208-00-7 | 242-555-3 | 330-54-1 |
3. In Appendix 6, the following entries are inserted:
| Substances | Indenx 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 | - | - |
| reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1) | 015-207-00-1 | - | - |
| 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 |
In addition, since entries 28, 29, and 30 of Annex XVII do not apply to several fuels and oil products, derogations for cumene are introduced in Appendix 11 as follows:
| 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:
|
This Regulation shall enter into force 20 days after its publication in Official Journal of the European Union. The restriction on the newly added CMR substances will apply from September 1, 2025.
The draft act can be accessed here.
