EUROPE | ECHA updates the List of restricted substances under REACH Annex XVII

Eurofins newsflash Chemical

Europe

ECHA updates the List of restricted substances under REACH Annex XVII

On 16^th December 2020, the European Union (EU) published Regulation (EU) No 2020/2096, which updated Annex XVII of REACH. Summarized below are the main updates on the restricted substances included:

Entry number	Substance name	EC number	CAS number	Reason for inclusion	Start applying date
3	Liquid substances or mixtures fulfilling the criteria for some hazard classes or categories^[1] set out in Annex I to Regulation (EC) No 1272/2008	-	-	References to labelling with R65 in paragraphs 3 and 5 that were set out according to the repealed Directive 67/548/EEC (DSD) has been deleted and therefore substitute by H304 to align it with Regulation (EC) No 1272/2008 (CLP)	05/01/2021
3		-	-	Paragraphs 6 and 7 were deleted since ECHA concluded that there is no need to propose an amendment of this restriction	05/01/2021
Entry 22	Pentachlorophenol and its salts and esters	201-778-6 and its salts and esters	87-86-5	Deleted from Annex XVII to REACH since more severe restrictions are laid down for these substances in POP Recast Regulation (EU) 2019/1021 on Persistent Organic Pollutants	05/01/2021
Entry 67	Bis(pentabromophenyl)ether (decabromodiphenyl ether; decaBDE)	214-604-9	1163-19-5		05/01/2021
Entry 68	Perfluorooctanoic acid (PFOA) and its salts	206-397-9	335-67-1		04/07/2020
Entries 28, 29 and 30	Substances which are classified as carcinogen, germ cell mutagen and reproductive toxicant categories 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendices 1 or 2, 3 or 4 and 5 or 6, respectively.	-	-	For Entry 28: - New entries are inserted in Appendix 2^[2] to align them with CLP Regulation For Entry 30: - New entry is inserted in Appendix 5²to align it with CLP Regulation - New entries are inserted in Appendix 6²to align them with CLP Regulation	05/07/2021 or 01/10/2021 depending on the new substances listed in the specific Appendices.
				A new exemption is added in Point (f): devices covered by Regulation (EU) 2017/745 Medical devices are exempted from the restriction since it is covered by Regulation (EU) 2017/745 to avoid double regulation	05/01/2021
				For Entry 28: - The titles of Appendix 1 and 2 are replaced by the following respectively: ‘Entry 28 – Carcinogens: Category 1A’ and ‘Entry 28 – Carcinogens: Category 1B’ according to CLP Regulation For Entry 29: - The titles of Appendix 3 and 4 are replaced by the following respectively: ‘Entry 29 – Germ cell mutagens: Category 1 A’ and ‘Entry 29 – Germ cell mutagens: Category 1 B’ according to CLP Regulation For Entry 30: - The titles of Appendix 5 and 6 are replaced by the following respectively: ‘Entry 30 – Reproductive toxicants: Category 1 A’ and ‘Entry 30 – Reproductive toxicants: Category 1 B’ according to CLP	05/01/2021
Entry 43	Azocolourants and Azodyes	-	-	More up-to-date testing methods for azocolourants according to table for Appendix 10 below are included	05/01/2021
Entry 46	(a) Nonylphenol	246-672-0	25154-52-3	References to CAS number and EC numbers in paragraph (a) of column 1 are deleted in order to cover all isomers by this entry	05/01/2021

[1] For any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1.

[2] Substances classified as CMR and listed in Appendices 1 to 6 to that Annex and of mixtures containing such substances above specified concentrations shall be prohibited to place on the market and use for supply to the general public.

Appendix 10 Entry 43 – Azocolourants – List of testing methods
European standardization organisation	Reference and title of the harmonized standard	Reference of the superseded standard
CEN	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 ISO 17234-1:2010
CEN	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 14362-1:2012
CEN	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	EN 14362-3:2012

For consulting all updates, go to the official version/publication here.