EU Approved Amendment to Add New CMR Substances (Entries 28, 29 and 30) of Annex XVII to REACH Regulation
| Targeted audience | EU/EEA manufacturers, EU/EEA importers and their upstream providers |
| Products concerned | Consumer products (substances, mixtures) |
| Key industries concerned with this insight | Paints, adhesives |
| Application date | 1 September 2025 |
| Main content or requirements | On 11 August 2025, the European Commission amended the REACH Regulation by adding 16 CMR substances to Appendices 2,4 and 6 of Annex XVII Entries 28, 29 and 30. Their content limits in substances and mixtures are 0.1% each (0.3% for reproductive toxicants) by default |
| Reference |
On 11 August 2025, the European Commission published Regulation (EU) 2025/1731 to approve adding 16 CMR substances to Appendices 2,4 and 6 of Annex XVII Entries 28, 29 and 30 of the EU REACH Regulation (EC) No 1907/2006. The amendment shall apply from 1 September 2025.
Entries 28, 29 and 30 of Annex XVII to REACH Regulation prohibit the placing on the market and use, for supply to the general public, of substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A or 1B, and listed in appendices 1 to 6 to that annex and of mixtures containing such substances above specified concentrations.
New entries shall be added in Appendices 2, 4 and 6 of Annex XVII of the EU REACH Regulation, as follows:
Appendix 2 (Entry 28 - Carcinogens: Category 1B) - Content limit: 0.1%
| Substances | EC No | CAS No |
| Diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea | 206-354-4 | 330-54-1 |
| 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol (tetrabromobisphenol-A, TBBPA) | 201-236-9 | 79-94-7 |
| N,N-Dimethyl-p-toluidine | 202-805-4 | 99-97-8 |
| 4-Nitrosomorpholine | -- | 59-89-2 |
| 4-Methylimidazole | 212-497-3 | 822-36-6 |
(The content limit for 4-nitrosomorpholine is 0.001%)
Appendix 4 (Entry 29 - Germ cell mutagens: Category 1B) - Content limit: 0.1%
| Substances | EC No | CAS No |
| Dimethyl propylphosphonate | 242-555-3 | 18755-43-6 |
Appendix 6 (Entry 30 - Reproductive toxicants: Category 1B) - Content limit: 0.3%
| Substances | EC No | CAS No |
| Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide | 278-355-8 | 75980-60-8 |
| Benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate | 479-100-5 | 577705-90-9 |
| Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) | 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) | -- | -- |
| 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) | -- | -- |
| Dimethyl propylphosphonate | 242-555-3 | 18755-43-6 |
| Dibutyltin maleate | 201-077-5 | 78-04-6 |
| Dibutyltin oxide | 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 | -- | -- |
| 4,4'-[2,2,2-Trifluoro-1-(trifluoromethyl)ethylidene]diphenol (bisphenol AF, BPAF) | 216-036-7 | 1478-61-1 |
| 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs. | 273-227-8 | 68953-84-4 |
| 4-Methylimidazole | 212-497-3 | 822-36-6 |
The substance cumene (CAS No. 98-82-8) is exempted when it is present as a substance on its own or as a constituent of other substances in kerosene or gasoline aviation fuel under certain conditions.
Note:
EU REACH Annex XVII: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles
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