In April 2021, the European Commission has proposed Commission Regulation (EU) to add new CMR substances to Appendix 2,4 and 6 of Annex XVII to REACH Regulation (EC) No 1907/2006.
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 Appendix 2, 4 and 6 of Annex XVII of EU REACH Regulation, as followings:
Appendix 2 (Entry 28 – Carcinogens: Category 1B)
| Substances | Index No | EC No | CAS No | Proposed Effective date |
| silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) | 014-048-00-5 | 206-991-8 |
409-21-2 308076-74-6 |
1 March 2022 |
| dibenzo[def,p]chrysene; dibenzo[a,l]pyrene | 601-092-00-0 | 205-886-4 | 191-30-0 | 1 March 2022 |
| tetrafluoroethylene | 602-110-00-X | 204-126-9 | 116-14-3 | To be determined |
| 1,4-dioxane | 603-024-00-5 | 204-661-8 | 123-91-1 | To be determined |
| m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether | 603-065-00-9 | 202-987-5 | 101-90-6 | 1 March 2022 |
| 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide | 603-066-00-4 | 203-437-7 | 106-87-6 | To be determined |
| 2,2-bis(bromomethyl)propane-1,3-diol | 603-240-00-X | 221-967-7 | 3296-90-0 | 1 March 2022 |
| sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N- (hydroxymethyl)glycinate] | 607-746-00-1 | 274-357-8 | 70161-44-3 | 1 March 2022 |
| butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime | 616-014-00-0 | 202-496-6 | 96-29-7 | 1 March 2022 |
| N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 616-230-00-5 | 213-103-2 | 924-42-5 | 1 March 2022 |
Appendix 4 (Entry 29 – Germ cell mutagens: Category 1B)
| Substances | Index No | EC No | CAS No | Proposed Effective date |
| 2,2-bis(bromomethyl)propane-1,3-diol | 603-240-00-X | 221-967-7 | 3296-90-0 | 1 March 2022 |
| N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 616-230-00-5 | 213-103-2 | 924-42-5 | 1 March 2022 |
Appendix 6 (Entry 30 – Reproductive toxicants: Category 1B)
| Substances | Index No | EC No | CAS No | Proposed Effective date |
| mancozeb (ISO); manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt | 006-076-00-1 | - | 8018-01-7 | To be determined |
| tris(2-methoxyethoxy)vinylsilane; 6-(2- methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane | 014-050-00-6 | 213-934-0 | 1067-53-4 | 1 March 2022 |
| dichlorodioctylstannane | 050-021-00-4 | 222-583-2 | 3542-36-7 | 1 March 2022 |
|
dioctyltin dilaurate; [1]
stannane,dioctyl-,bis(coco acyloxy) derivs. [2] |
050-031-00-9 |
222-883-3 [1] 293-901-5 [2] |
3648-18-8 [1] 91648-39-4 [2] |
1 March 2022 |
| 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4- vinylcyclohexene diepoxide | 603-066-00-4 | 203-437-7 | 106-87-6 | To be determined |
| ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4- triazol-1-ylmethyl)cyclopentanol | 603-237-00-3 | - |
125225-28-7 115850-69-6 115937-89-8 |
1 March 2022 |
| bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme | 603-238-00-9 | 205-594-7 | 143-24-8 | 1 March 2022 |
| 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC] | 604-095-00-5 | 204-327-1 | 119-47-1 | To be determined |
| 2-(4-tert-butylbenzyl)propionaldehyde | 605-041-00-3 | 201-289-8 | 80-54-6 | 1 March 2022 |
| diisooctyl phthalate | 607-740-00-9 | 248-523-5 | 27554-26-3 | 1 March 2022 |
| 2-methoxyethyl acrylate | 607-744-00-0 | 221-499-3 | 3121-61-7 | 1 March 2022 |
| dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine | 613-102-00-0 | 404-200-2 | 110488-70-5 | To be determined |
| 1,2,4-triazole | 613-111-00-X | 206-022-9 | 288-88-0 | To be determined |
| pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc | 613-333-00-7 | 236-671-3 | 13463-41-7 | 1 March 2022 |
| flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one | 613-334-00-2 | 262-661-3 | 61213-25-0 | 1 March 2022 |
| 3-methylpyrazole | 613-339-00-X | 215-925-7 | 1453-58-3 | To be determined |
| bis(α,α-dimethylbenzyl) peroxide | 617-006-00-X | 201-279-3 | 80-43-3 | 1 March 2022 |
Note:
Annex XVII: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles
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