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The European Commission has published Regulation (EU) 2018/675 to amend Annex XVII of REACH Regulation (EC) No 1907/2006 as regards substances that are classified as carcinogenic, mutagenic and toxic to reproduction (CMR). All the amendments to Entries 28, 29, 30, and Appendices 2, 4, 6 of Annex XVII have been approved as proposed. The regulation shall apply from 1 December 2018, except the addition of the substance “formaldehyde … %” to Appendix 2 shall apply from 24 May 2018. Here are the highlights of the amendment:
1.Column 1 of entries 28 to 30 of Annex XVII is replaced by the following:
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28. Substances which are classified as carcinogen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 1 or Appendix 2, respectively.
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29. Substances which are classified as germ cell mutagen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 3 or Appendix 4, respectively.
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30. Substances which are classified as reproductive toxicant category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 5 or Appendix 6, respectively.
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2. In Appendix 2 (for Entry 28 - Carcinogens belonging to category 1B or 2), the following entries are ｉｎｓｅｒｔed in the table:
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Substances
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Index No
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EC No
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CAS No
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Notes
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2,3-epoxypropyl methacrylate;
glycidyl methacrylate
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607-123-00-4
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203-441-9
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106-91-2
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cadmium carbonate
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048-012-00-5
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208-168-9
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513-78-0
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cadmium hydroxide; cadmium dihydroxide
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048-013-00-0
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244-168-5
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21041-95-2
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cadmium nitrate;
cadmium dinitrate
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048-014-00-6
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233-710-6
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10325-94-7
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formaldehyde ...%
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605-001-00-5
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200-001-8
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50-00-0
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anthraquinone
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606-151-00-4
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201-549-0
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84-65-1
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N,N’-methylenedimorpholine;
N,N’-methylenebismorpholine;
[formaldehyde released from N,N’-methylenebismorpholine];
[MBM]
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607-721-00-5
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227-062-3
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5625-90-1
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reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2);
[formaldehyde released from 3,3’-methylenebis[5-methyloxazolidine];
formaldehyde released from oxazolidin];
[MBO]
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612-290-00-1
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-
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-
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reaction products of paraformaldehyde with 2-hydroxypropylamine (ratio 1:1);
[formaldehyde released from α,α,α-trimethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol];
[HPT]
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612-291-00-7
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-
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-
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methylhydrazine
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612-292-00-2
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200-471-4
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60-34-4
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3. In Appendix 4 (for Entry 29 - Mutagens belonging to category 1B or 2), the following entries are ｉｎｓｅｒｔed in the table:
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Substances
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Index No
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EC No
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CAS No
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Notes
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cadmium carbonate
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048-012-00-5
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208-168-9
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513-78-0
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cadmium hydroxide; cadmium dihydroxide
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048-013-00-0
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244-168-5
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21041-95-2
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cadmium nitrate;
cadmium dinitrate
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048-014-00-6
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233-710-6
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10325-94-7
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4. In Appendix 6 (for Entry 30 - Reproductive toxicants belonging to category 1B or 2), the following entries are ｉｎｓｅｒｔed in the table:
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Substances
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Index No
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EC No
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CAS No
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Notes
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2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
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606-041-00-6
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400-600-6
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71868-10-5
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2,3-epoxypropyl methacrylate;
glycidyl methacrylate
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607-123-00-4
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203-441-9
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106-91-2
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cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
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650-032-00-X
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-
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94361-06-5
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dibutyltin dilaurate; dibutyl[bis(dodecanoyloxy)]stannane
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050-030-00-3
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201-039-8
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77-58-7
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nonadecafluorodecanoic acid; [1]
ammonium nonadecafluorodecanoate; [2]
sodium nonadecafluorodecanoate [3]
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607-720-00-X
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[1]206-400-3
[2]221-470-5
[3] -
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335-76-2 [1]
3108-42-7 [2]
3830-45-3 [3]
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triadimenol (ISO); (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol;
α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol
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613-322-00-7
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259-537-6
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55219-65-3
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quinolin-8-ol;
8-hydroxyquinoline
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613-324-00-8
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205-711-1
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148-24-3
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thiacloprid (ISO);
(Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide;
{(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide
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613-325-00-3
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-
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111988-49-9
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carbetamide (ISO);
(R)-1-(ethylcarbamoyl)ethyl carbanilate; (2R)-1-(ethylamino)-1-oxopropan-2-yl phenylcarbamate
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616-223-00-7
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240-286-6
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16118-49-3
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Note:
CLP Regulation (EC) No 1272/2008: Regulation on on classification, labelling and packaging of substances and mixtures
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