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 |
