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EU Proposes to Revise REACH

SafeGuardSElectrical Medical Devices, EE Restricted Substances, DIY Tools and Hardware, HG Restricted Substances, Home Furnishings and Houseware, Sports and Leisure, Footwear and Leather Products, Home Textiles, SL Restricted Substances, Jewelry Bags and AccessoriesMay 04, 2020

The EU has informed the WTO of its intention to revise Annex XVII of REACH. The provisions in the draft amendment will be implemented in phases.

On April 23, 2020, the World Trade Organization (WTO) circulated a proposal from the European Union (EU) announcing its intention to revise Annex XVII of REACH ‘Restrictions on the manufacturing, placing on the market and use of certain dangerous substances, mixtures and articles’. The draft regulation and Annex, attached to WTO document number 20-3204, contain several important changes:

  • Deleting three entries:
    • Entries 22 (pentachlorophenol, PCP) and 67 (decabromodiphenyl ether, DecaBDE) as these are now regulated under Regulation (EU) 2019/1021 on persistent organic pollutants (POP Recast)
    • Entry 68 (perfluorooctanoic acid (PFOA) and its salts, and PFOA-related substances) as this will be regulated under POP Recast by amendment
  • Editorial changes in language to align with Regulation (EC) 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation), including hazard statements
  • Exempting devices falling under Regulation (EU) 2017/745 (medical devices) from entries 28 to 30 on carcinogenic, mutagenic or reproductive category 1A and 1B substances (CMR category 1A and 1B substances)
  • Adding CMR category 1A and/or 1B substances to entries 28 to 30 to align with the CLP Regulation, including cobalt, two polycyclic aromatic hydrocarbons (PAHs) and diisohexyl phthalate (DIHP)
  • Deleting CAS and EC numbers for entry 46 (nonylphenol, NP) as the intention was to cover all isomers of NP
  • Replacing the list of harmonized standards in Appendix 10 for demonstrating compliance with azo colorants

According to the WTO document, there are two important proposed dates:

  • Q4 of 2020 for date of adoption
  • 20 days from publication in the Official Journal of the EU for date of entry into force. The provisions will be implemented in phases

Highlights of the list of standards for presumption of conformity with azo colorants under Appendix 10 to Annex XVII of REACH are summarized in Table 1.

WTO Document Number 20-3204, APRIL 23, 2020
Appendix 10 to Annex XVII of Regulation (EC) 1907/2006 ‘REACH’
EntryHarmonized StandardSuperseded Standard
1EN 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
2EN ISO 17234-2:2011
Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 2: Determination of 4-aminoazobenzene
CEN ISO/TS 17234:2003
3EN 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 fibers
EN 14362-1:2012
4EN 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

Table 1

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