In April 2020, theEuropean Commission has proposed Commission Regulation to amend Annex XVII toREACH Regulation (EC) No 1907/2006. These amendments have not been effectiveyet. The following are the highlight of the amendments:
Amendments to Entry3 (Liquid substances or mixtures which are regarded as dangerous)
1. The Risk Phase “R65” shall be deleted in this entry (point 3, 5 and 7 ofthe restrictions).
2. The restriction concerning the dossier prepared by the EuropeanChemicals Agency in point 6 shall be deleted.
Amendments to Entry22 (Pentachlorophenol)
This entry shall be deleted.
Amendments toEntries 28, 29 and 30 (Substances which are classified as carcinogen category1A or 1B, germ cell mutagen category 1A or 1B and reproductive toxicantcategory 1A or 1B)
The devices covered by Regulation (EU) 2017/45 shall not apply to therestrictions of these entries.
Note:
Regulation (EU) 2017/45: Regulation on medical devices
Amendments to Entry67 (Bis(pentabromophenyl)ether (decabromodiphenyl ether; decaBDE))
This entry shall be deleted.
Amendments to Entry68 (Perfluorooctanoic acid (PFOA) and its salts)
This entry shall be deleted.
Amendments toAppendix 2 (Entry 28 – Carcinogens: Category 1B)
The following entries shall be added in the table:
|
Substances |
Index No |
EC No |
CAS No |
|
cobalt |
027-001-00-9 |
231-158-0 |
7440-48-4 |
|
benzo[rst]pentaphene |
601-090-00-X |
205-877-5 |
189-55-9 |
|
dibenzo[b,def]chrysene; dibenzo[a,h]pyrene |
601-091-00-5 |
205-878-0 |
189-64-0 |
|
1,2-dihydroxybenzene; pyrocatechol |
604-016-00-4 |
204-427-5 |
120-80-9 |
|
acetaldehyde; ethanal |
605-003-00-6 |
200-836-8 |
75-07-0 |
|
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 |
Amendments toAppendix 5 (Entry 30 – Reproductive toxicants: Category 1A)
The following entry shall be added in the table:
|
Substances |
Index No |
EC No |
CAS No |
|
methylmercuric chloride |
080-012-00-0 |
204-064-2 |
115-09-3 |
Amendments toAppendix 6 (Entry 30 – Reproductive toxicants: Category 1B)
The following entry shall be added in the table:
|
Substances |
Index No |
EC No |
CAS No |
|
cobalt |
027-001-00-9 |
231-158-0 |
7440-48-4 |
|
ethylene oxide; oxirane |
603-023-00-X |
200-849-9 |
75-21-8 |
|
ethanol, 2,2'-iminobis-, N-(C13-15 branched and linear alkyl) derivs. |
603-236-00-8 |
308-208-6 |
97925-95-6 |
|
2-benzyl-2-dimethylamino-4’-morpholinobutyrophenone |
606-047-00-9 |
404-360-3 |
119313-12-1 |
|
diisohexyl phthalate |
607-737-00-2 |
276-090-2 |
71850-09-4 |
|
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 |
|
1-vinylimidazole |
613-328-00-X |
214-012-0 |
1072-63-5 |
|
halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6dimethoxypyrimidin-2yl)carbamoyl]sulfamoyl}-1-methyl1H-pyrazole-4-carboxylate |
613-329-00-5 |
- |
100784-20-1 |
|
2-methylimidazole |
613-330-00-0 |
211-765-7 |
693-98-1 |
|
dibutylbis(pentane-2,4-dionato-O,O')tin |
650-056-00-0 |
245-152-0 |
22673-19-4 |
Amendments toAppendix 10 (Entry 43 — Azocolourants — List of testing methods)
The following testing standards shall be updated:
|
Current testing standard |
Proposed 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 |
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