EU Approved Commission Regulation to Amend Annex XVII to REACH Regulation (EC) No 1907/2006 Regard the Entries and the Testing Methods of Azocolourants
On 16 December 2020, the European Commission has published Commission Regulation (EU) 2020/2096 to amend Annex XVII to REACH Regulation (EC) No 1907/2006. The amendments shall enter in force on 5 January 2021, unless specified in individual substance. The following are the highlight of the amendments:
Amendments to Entry 3 (Liquid substances or mixtures which are regarded as dangerous)
- The Risk Phase ¡°R65¡± shall be deleted in this entry (point 3 and 5 of the restrictions).
- The restrictions in point 6 and 7 shall be deleted.
Amendments to Entries 28, 29 and 30 (Substances which are classified as carcinogen category 1A or 1B, germ cell mutagen category 1A or 1B and reproductive toxicant category 1A or 1B)
The devices covered by Regulation (EU) 2017/45 shall not apply to the restrictions of these entries.
Amendments to Appendix 2 (Entry 28 ¨C Carcinogens: Category 1B)
The following entries shall be added in the table:
| Substances | Index No | EC No | CAS No | Effective date |
| cobalt | 027-001-00-9 | 231-158-0 | 7440-48-4 | 1 October 2021 |
| benzo[rst]pentaphene | 601-090-00-X | 205-877-5 | 189-55-9 | 1 October 2021 |
| dibenzo[b,def]chrysene; dibenzo[a,h]pyrene | 601-091-00-5 | 205-878-0 | 189-64-0 | 1 October 2021 |
| 1,2-dihydroxybenzene; pyrocatechol | 604-016-00-4 | 204-427-5 | 120-80-9 | 5 July 2021 |
| acetaldehyde; ethanal | 605-003-00-6 | 200-836-8 | 75-07-0 | 5 July 2021 |
| spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate | 607-730-00-4 | - | 148477-71-8 | 5 July 2021 |
Amendments to Appendix 5 (Entry 30 ¨C Reproductive toxicants: Category 1A)
The following entry shall be added in the table:
| Substances | Index No | EC No | CAS No | Effective date |
| methylmercuric chloride | 080-012-00-0 | 204-064-2 | 115-09-3 | 1 October 2021 |
Amendments to Appendix 6 (Entry 30 ¨C Reproductive toxicants: Category 1B)
The following entry shall be added in the table:
| Substances | Index No | EC No | CAS No | Effective date |
| cobalt | 027-001-00-9 | 231-158-0 | 7440-48-4 | 1 October 2021 |
| ethylene oxide; oxirane | 603-023-00-X | 200-849-9 | 75-21-8 | 1 October 2021 |
| ethanol, 2,2'-iminobis-, N-(C13-15 branched and linear alkyl) derivs. | 603-236-00-8 | 308-208-6 | 97925-95-6 | 1 October 2021 |
| 2-benzyl-2-dimethylamino-4¡¯-morpholinobutyrophenone | 606-047-00-9 | 404-360-3 | 119313-12-1 | 5 July 2021 |
| diisohexyl phthalate | 607-737-00-2 | 276-090-2 | 71850-09-4 | 1 October 2021 |
| propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl}-1H-1,2,4-triazole | 613-205-00-0 | 262-104-4 | 60207-90-1 | 5 July 2021 |
| 1-vinylimidazole | 613-328-00-X | 214-012-0 | 1072-63-5 | 5 July 2021 |
| halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6dimethoxypyrimidin-2yl)carbamoyl]sulfamoyl}-1-methyl1H-pyrazole-4-carboxylate | 613-329-00-5 | - | 100784-20-1 | 1 October 2021 |
| 2-methylimidazole | 613-330-00-0 | 211-765-7 | 693-98-1 | 1 October 2021 |
| dibutylbis(pentane-2,4-dionato-O,O')tin | 650-056-00-0 | 245-152-0 | 22673-19-4 | 1 October 2021 |
Amendments to Appendix 10 (Entry 43 - Azocolourants - List of testing methods)
The following testing standards shall be updated:
| Current testing standard | Updated testing standard |
| EN ISO 17234-1:2010 Leather - Chemical tests for the determination of certain azo colorants in dyed leathers - Part 1: Determination of certain aromatic amines derived from azo colorants | EN ISO 17234-1:2015 Leather - Chemical tests for the determination of certain azo colorants in dyed leathers - Part 1: Determination of certain aromatic amines derived from azo colorants |
| EN 14362-1:2012 Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres | EN ISO 14362-1:2017 Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres |
| EN 14362-3:2012 Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene | EN ISO 14362-3:2017 Textiles - Methods for determination of certain aromatic amines derived from azo colorants - Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene |
Amendments to Entry 46 ((a) Nonylphenol, (b) Nonylphenol ethoxylates)
The references to CAS number and EC number in paragraph (a) of column 1 are deleted.
Besides, the following entries shall be deleted:
- Entry 22 (Pentachlorophenol)
- Entry 67 (Bis(pentabromophenyl)ether (decabromodiphenyl ether; decaBDE))
- Entry 68 (Perfluorooctanoic acid (PFOA) and its salts) from 4 July 2020.