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EU REACH: Various Entries of Annex XVII Are Updated

DECEMBER 2020 - ELECTRICAL AND ELECTRONICS, HARDLINES, SOFTLINES, TOYS AND CHILDREN'S PRODUCTS

On 16 December 2020, the Official Journal of European Union (OJEU) published Regulation (EU) No 2020/20961, which amended various entries of Annex XVII to REACH Regulation.

The new Regulation amended some of REACH Annex XVII restrictions. Entries 22 (pentachlorophenol and its salts and esters (PCP), 67 (decabromodiphenyl ether (DecaBDE)) and 68 (perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds) are deleted from Annex XVII, because these restricted substances have been incorporated into POPs Regulation (EU) 2019/1021. The amendments also include the update of harmonized testing methods for demonstration of compliance of azo dyes under entry 43 of Annex XVII of REACH. Majority of the amendments will apply from 5 January 2021, except entries 28-30 and 68. 

Please see tables below for the amendment highlights.

Table 1. Relevant entries and highlights of amendments

Entry  Substances Amendment
Entry 3 Liquid substances or mixtures
  • Labelling with R65 is deleted as Directive 67/548/EEC has been repealed;
  • Request to ECHA for amendment of this entry is deleted
Entry 22 Pentachlorophenol and its salts and esters This entry is deleted from Annex XVII as the substances have been incorporated into POPs Regulation (EU) 2019/1021.
Entry 28-30 Carcinogenic, mutagenic or reproductive toxic (CMR) substances  
  • New classification of substances applied;
  • A new exemption for medical devices covered by Regulation (U) 2017/745 is included;
  • Some new substances are included into the Appendix 1-6.
The amendment will apply from 5 July 2021 or 1 October 2021 depending on the substances listed. 
Entry 43 Azo dyes The testing methods in Appendix 10 are updated. See Table 2 for details.
Entry 46 Nonylphenol, Nonylphenol ethoxylates CAS number and EC number for nonylphenol are deleted as this entry should cover all isomers of nonylphenol
Entry 67  Decabromodiphenyl ether (DecaBDE) This entry is deleted from Annex XVII as the substances have been incorporated into POPs Regulation (EU) 2019/1021.
Entry 68 Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds  

This entry is deleted from Annex XVII as the substances have been incorporated into POPs Regulation (EU)2019/1021.

This applied from 4 July 2020.

Table 2. Amendment of testing methods for azo dyes in Appendix 10
 
European standardisation organisation Reference and title of the harmonised standard 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 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 CEN ISO/TS 17234:2003
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

 

[1]  Regulation (EU) No 2020/2096

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