EU Approved Amendments to Add New CMR Substances (Entries 28, 29 and 30) in Annex XVII to REACH Regulation
On 14 December 2021, the European Commission has published Commission Regulation (EU) 2021/2204 to approve adding new CMR substances to appendices 2,4 and 6 of Annex XVII entries 28, 29 and 30 to REACH Regulation (EC) No 1907/2006. The amendment shall enter into force on 3 January 2022.
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 EU REACH Regulation, as followings:
Appendix 2 (Entry 28 – Carcinogens: Category 1B)
| Substances |
Index No |
EC No |
CAS No |
Apply 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 |
17 December 2022 |
| 1,4-dioxane |
603-024-00-5 |
204-661-8 |
123-91-1 |
17 December 2022 |
| 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 |
17 December 2022 |
| 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 |
Apply 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 |
Apply Date |
| mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt |
006-076-00-1 |
- |
8018-01-7 |
17 December 2022 |
| 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 |
17 December 2022 |
| 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 |
17 December 2022 |
| 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 |
17 December 2022 |
| 1,2,4-triazole |
613-111-00-X |
206-022-9 |
288-88-0 |
17 December 2022 |
| 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 |
17 December 2022 |
| bis(α,α-dimethylbenzyl) peroxide |
617-006-00-X |
201-279-3 |
80-43-3 |
1 March 2022 |
Note:
REACH Annex XVII: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles
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