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Commission Regulation (EU) 2018/675 of 2 May 2018 amending the Appendices to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards CMR substances (Text with EEA relevance)

In forceVersion 2018-05-02from 2018-05-24
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Contents
  1. Preamble
    1. Article 1
    2. Article 2
  3. ANNEX
  4. ANNEX

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, and in particular Articles 68(2) and 131 thereof,

Whereas:

(1) Entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the placing on the market or use for supply to the general public of substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A or 1B, and of mixtures containing such substances in specified concentrations. The substances concerned are listed in Appendices 1 to 6 to that Annex.

(2) Substances are classified as CMR in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council and are listed in Part 3 of Annex VI to that Regulation.

(3) Since Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006 were last updated to reflect new classifications of substances as CMR under Regulation (EC) No 1272/2008, Part 3 of Annex VI to the latter has been amended by Commission Regulation (EU) 2017/776.

(4) Regulation (EU) 2017/776 also makes changes to titles and numbering in Part 3 of Annex VI to Regulation (EC) No 1272/2008, which necessitate modification of the references to that Regulation in column 1 of entries 28 to 30 of Annex XVII to Regulation (EC) No 1907/2006.

(5) The substance formaldehyde was classified as a carcinogen category 1B by Commission Regulation (EU) No 605/2014; however the Commission chose to omit it from the last updating exercise pending the outcome of an ongoing examination of all its uses by the European Chemicals Agency, with a view to a possible specific restriction. In the meeting of the committee established under Article 133(1) of Regulation (EC) No 1907/2006, held on 16 March 2017, the majority of Member States expressed a preference to include formaldehyde in entry 28 of Annex XVII to REACH notwithstanding any further specific proposal to restrict the substance, and the Commission agreed to do so at the next available opportunity.

(6) As operators may apply the harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008 at an earlier date, they should be able to apply the provisions of this Regulation earlier, on a voluntary basis.

(7) Regulation (EC) No 1907/2006 should be amended accordingly.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Article 1

Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex.

Article 2

1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2. It shall apply from 1 December 2018 except that, to the extent that paragraph 2 of the Annex applies to the substance formaldehyde … %, that paragraph shall apply from the date of entry into force.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 2 May 2018. For the Commission The President Jean-Claude Juncker

ANNEX

(1) Column 1 of entries 28 to 30 is replaced by the following: 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. 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. 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. (2) In Appendix 2, the following entries are inserted in the table in order of the index numbers set out therein: 2,3-epoxypropyl methacrylate; glycidyl methacrylate 607-123-00-4 203-441-9 106-91-2 cadmium carbonate 048-012-00-5 208-168-9 513-78-0 cadmium hydroxide; cadmium dihydroxide 048-013-00-0 244-168-5 21041-95-2 cadmium nitrate; cadmium dinitrate 048-014-00-6 233-710-6 10325-94-7 formaldehyde … % 605-001-00-5 200-001-8 50-00-0 anthraquinone 606-151-00-4 201-549-0 84-65-1 N,N′-methylenedimorpholine; N,N′-methylenebismorpholine; [formaldehyde released from N,N′-methylenebismorpholine]; [MBM] 607-721-00-5 227-062-3 5625-90-1 reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2); [formaldehyde released from 3,3′-methylenebis[5-methyloxazolidine]; formaldehyde released from oxazolidin]; [MBO] 612-290-00-1 — — 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] 612-291-00-7 — — methylhydrazine 612-292-00-2 200-471-4 60-34-4 (3) In Appendix 4, the following entries are inserted in the table in order of the index numbers set out therein: cadmium carbonate 048-012-00-5 208-168-9 513-78-0 cadmium hydroxide; cadmium dihydroxide 048-013-00-0 244-168-5 21041-95-2 cadmium nitrate; cadmium dinitrate 048-014-00-6 233-710-6 10325-94-7 (4) In Appendix 6, the following entries are inserted in the table in order of the index numbers set out therein: 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one 606-041-00-6 400-600-6 71868-10-5 2,3-epoxypropyl methacrylate; glycidyl methacrylate 607-123-00-4 203-441-9 106-91-2 cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol 650-032-00-X — 94361-06-5 dibutyltin dilaurate; dibutyl[bis(dodecanoyloxy)]stannane 050-030-00-3 201-039-8 77-58-7 nonadecafluorodecanoic acid; [1] ammonium nonadecafluorodecanoate; [2] sodium nonadecafluorodecanoate [3] 607-720-00-X 206-400-3 [1] 221-470-5 [2] [3] 335-76-2 [1] 3108-42-7 [2] 3830-45-3 [3] 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 613-322-00-7 259-537-6 55219-65-3 quinolin-8-ol; 8-hydroxyquinoline 613-324-00-8 205-711-1 148-24-3 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 613-325-00-3 — 111988-49-9 carbetamide (ISO); (R)-1-(ethylcarbamoyl)ethyl carbanilate; (2R)-1-(ethylamino)-1-oxopropan-2-yl phenylcarbamate 616-223-00-7 240-286-6 16118-49-3 Anx. annex. Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:

ANNEX

Annex XVII to Regulation (EC) No 1907/2006 is amended as follows: (1) Column 1 of entries 28 to 30 is replaced by the following: 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. 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. 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. (2) In Appendix 2, the following entries are inserted in the table in order of the index numbers set out therein: 2,3-epoxypropyl methacrylate; glycidyl methacrylate 607-123-00-4 203-441-9 106-91-2 cadmium carbonate 048-012-00-5 208-168-9 513-78-0 cadmium hydroxide; cadmium dihydroxide 048-013-00-0 244-168-5 21041-95-2 cadmium nitrate; cadmium dinitrate 048-014-00-6 233-710-6 10325-94-7 formaldehyde … % 605-001-00-5 200-001-8 50-00-0 anthraquinone 606-151-00-4 201-549-0 84-65-1 N,N′-methylenedimorpholine; N,N′-methylenebismorpholine; [formaldehyde released from N,N′-methylenebismorpholine]; [MBM] 607-721-00-5 227-062-3 5625-90-1 reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2); [formaldehyde released from 3,3′-methylenebis[5-methyloxazolidine]; formaldehyde released from oxazolidin]; [MBO] 612-290-00-1 — — 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] 612-291-00-7 — — methylhydrazine 612-292-00-2 200-471-4 60-34-4 (3) In Appendix 4, the following entries are inserted in the table in order of the index numbers set out therein: cadmium carbonate 048-012-00-5 208-168-9 513-78-0 cadmium hydroxide; cadmium dihydroxide 048-013-00-0 244-168-5 21041-95-2 cadmium nitrate; cadmium dinitrate 048-014-00-6 233-710-6 10325-94-7 (4) In Appendix 6, the following entries are inserted in the table in order of the index numbers set out therein: 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one 606-041-00-6 400-600-6 71868-10-5 2,3-epoxypropyl methacrylate; glycidyl methacrylate 607-123-00-4 203-441-9 106-91-2 cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol 650-032-00-X — 94361-06-5 dibutyltin dilaurate; dibutyl[bis(dodecanoyloxy)]stannane 050-030-00-3 201-039-8 77-58-7 nonadecafluorodecanoic acid; [1] ammonium nonadecafluorodecanoate; [2] sodium nonadecafluorodecanoate [3] 607-720-00-X 206-400-3 [1] 221-470-5 [2] [3] 335-76-2 [1] 3108-42-7 [2] 3830-45-3 [3] 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 613-322-00-7 259-537-6 55219-65-3 quinolin-8-ol; 8-hydroxyquinoline 613-324-00-8 205-711-1 148-24-3 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 613-325-00-3 — 111988-49-9 carbetamide (ISO); (R)-1-(ethylcarbamoyl)ethyl carbanilate; (2R)-1-(ethylamino)-1-oxopropan-2-yl phenylcarbamate 616-223-00-7 240-286-6 16118-49-3

(1) Column 1 of entries 28 to 30 is replaced by the following: 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. 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. 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.

(2) In Appendix 2, the following entries are inserted in the table in order of the index numbers set out therein: 2,3-epoxypropyl methacrylate; glycidyl methacrylate 607-123-00-4 203-441-9 106-91-2 cadmium carbonate 048-012-00-5 208-168-9 513-78-0 cadmium hydroxide; cadmium dihydroxide 048-013-00-0 244-168-5 21041-95-2 cadmium nitrate; cadmium dinitrate 048-014-00-6 233-710-6 10325-94-7 formaldehyde … % 605-001-00-5 200-001-8 50-00-0 anthraquinone 606-151-00-4 201-549-0 84-65-1 N,N′-methylenedimorpholine; N,N′-methylenebismorpholine; [formaldehyde released from N,N′-methylenebismorpholine]; [MBM] 607-721-00-5 227-062-3 5625-90-1 reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2); [formaldehyde released from 3,3′-methylenebis[5-methyloxazolidine]; formaldehyde released from oxazolidin]; [MBO] 612-290-00-1 — — 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] 612-291-00-7 — — methylhydrazine 612-292-00-2 200-471-4 60-34-4

(3) In Appendix 4, the following entries are inserted in the table in order of the index numbers set out therein: cadmium carbonate 048-012-00-5 208-168-9 513-78-0 cadmium hydroxide; cadmium dihydroxide 048-013-00-0 244-168-5 21041-95-2 cadmium nitrate; cadmium dinitrate 048-014-00-6 233-710-6 10325-94-7

(4) In Appendix 6, the following entries are inserted in the table in order of the index numbers set out therein: 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one 606-041-00-6 400-600-6 71868-10-5 2,3-epoxypropyl methacrylate; glycidyl methacrylate 607-123-00-4 203-441-9 106-91-2 cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol 650-032-00-X — 94361-06-5 dibutyltin dilaurate; dibutyl[bis(dodecanoyloxy)]stannane 050-030-00-3 201-039-8 77-58-7 nonadecafluorodecanoic acid; [1] ammonium nonadecafluorodecanoate; [2] sodium nonadecafluorodecanoate [3] 607-720-00-X 206-400-3 [1] 221-470-5 [2] [3] 335-76-2 [1] 3108-42-7 [2] 3830-45-3 [3] 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 613-322-00-7 259-537-6 55219-65-3 quinolin-8-ol; 8-hydroxyquinoline 613-324-00-8 205-711-1 148-24-3 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 613-325-00-3 — 111988-49-9 carbetamide (ISO); (R)-1-(ethylcarbamoyl)ethyl carbanilate; (2R)-1-(ethylamino)-1-oxopropan-2-yl phenylcarbamate 616-223-00-7 240-286-6 16118-49-3

Versions

  1. 2018-05-02

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