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On June 8, 2023, European Commission announced to add 24 entries of CMR substances to Annex XVII to Regulation (EC) No 1907/2006. The list of substances was published in Commission Regulation (EU) 2023/1132 on the Official Journal of the European Union on June 9. The amendment will come into force on December 1, 2023.
As required by Annex XVII, any substances classified as categories 1A or 1B carcinogenic, mutagenic or reproductive toxicant (CMRs) will be prohibited from being placed on the market, used, or supplied to the general public. This restriction applies to substances listed in Appendices 1 to 6 of Appendix XVII and to mixtures containing substances above specified concentration.
The details of the amendments are shown below:
1. In Appendix 2: Add 4 carcinogenic substances (category 1A) as follows:
| Substances | Index No | EC No | CAS No |
| Divanadium pentaoxide; vanadium pentoxide | 023-001-00-8 | 215-239-8 | 1314-62-1 |
| Cumene | 601-024-00-X | 202-704-5 | 98-82-8 |
| 2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol | 603-243-00-6 | 253-057-0 | 36483-57-5; 1522-92-5 |
| Benzophenone | 606-153-00-5 | 204-337-6 | 119-61-9 |
2. In Appendix 6: Add 20 reproductive toxic substances (category 1B) as follows:
| Substances | Index No | EC No | CAS No |
| Ammonium bromide | 035-005-00-7 | 235-183-8 | 12124-97-9 |
| Dibutyltin bis(2-ethylhexanoate) | 050-032-00-4 | 220-481-2 | 2781-10-4 |
| Dibutyltin di(acetate) | 050-033-00-X | 213-928-8 | 1067-33-0 |
| Tellurium | 052-001-00-0 | 236-813-4 | 13494-80-9 |
| Tellurium dioxide | 052-002-00-6 | 231-193-1 | 7446-07-3 |
| Barium diboron tetraoxide | 056-005-00-3 | 237-222-4 | 13701-59-2 |
| 2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether | 603-107-00-6 | 203-906-6 | 111-77-3 |
| 2,4,6-tri-tert-butylphenol | 604-097-00-6 | 211-989-5 | 732-26-3 |
| 4,4'-sulphonyldiphenol; bisphenol S | 604-098-00-1 | 201-250-5 | 80-09-1 |
| 2-ethylhexanoic acid and its salts, with the exception of those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008 | 607-230-00-6 | - | - |
| Pentapotassium 2,2',2",2"’,2""-(ethane-1,2-diylnitrilo)pentaacetate | 607-734-00-6 | 404-290-3 | 7216-95-7 |
| N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid) | 607-735-00-1 | 200-652-8 | 67-43-6 |
| Pentasodium(carboxylatomethyl)iminobis (ethylenenitrilo)tetraacetate | 607-736-00-7 | 205-391-3 | 140-01-2 |
| Perfluoroheptanoic acid; tridecafluoroheptanoic acid | 607-761-00-3 | 206-798-9 | 375-85-9 |
| 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts | 607-763-00-4 | - | - |
| 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid | 607-764-00-X | - | 2156592-54-8 |
| 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid | 607-765-00-5 | - | - |
| Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione | 613-342-00-6 | 200-385-7 | 58-55-9 |
| N-(2-nitrophenyl)phosphoric triamide | 616-238-00-9 | 477-690-9 | 874819-71-3 |
| Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [> 78 % syn isomers < 15 % anti isomers relative content]; isopyrazam | 616-240-00-X | - | 881685-58-1 |
The regulation can be accessed here.
