The EU has revised Annex XVII of REACH. The provisions will be implemented in phases, starting January 5, 2021.
On December 16, 2020 the European Union (EU) published Regulation (EU) 2020/2096 to revise Annex XVII of Regulation (EC) 1907/2006 on Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH, consolidated version to August 2020) in relation to ‘Restrictions on the manufacturing, placing on the market and use of certain dangerous substances, mixtures and articles’.
The new law contains several important changes. It:
- Deletes entries 22 (pentachlorophenol (PCP, its salts and esters)), 67 (decabromodiphenyl ether, Deca-BDE) and 68 (perfluorooctanoic acid (PFOA) and its salts, and PFOA-related substances) as these are now regulated under Regulation (EU) 2019/1021 on persistent organic pollutants (POP Recast Regulation, consolidated version to September 2020)
- Edits the language to align with Regulation (EC) 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version to November 2020), including hazard statements
- Exempts 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)
- Adds CMR category 1A and/or 1B substances to entries 28 to 30 to align with the CLP Regulation, including cobalt, three polycyclic aromatic hydrocarbons (PAHs) and diisohexyl phthalate (DIHP)
- Deletes CAS and EC numbers for entry 46 (nonylphenol, NP) as the scope covers all isomers of NP
- Replaces the list of harmonized standards in Appendix 10 for demonstrating compliance with azo colorants
According to the latest amendment, the provisions are implemented in several phases:
- July 2020 for deleting entry 68 to Annex XVII of REACH (PFOA and its salts, and PFOA-related substances)
- July 5, 2021 and October 1, 2021 for provisions in Points (8)(b), (11)(b) and (12)(b) under Article 2
- January 5, 2021 for provisions other than those mentioned above
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.
| REGULATION (EU) 2020/2096 AMENDING ANNEX XVII OF REACH APPENDIX 10 ‘ENTRY 43 – AZOCOLORANTS – LIST OF TESTING METHODS’ | ||
|---|---|---|
| Entry | Harmonized Standard | Superseded Standard |
| 1 | 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 |
| 2 | EN 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 |
| 3 | 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 fibers | EN 14362-1:2012 |
| 4 | 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 |
Table 1
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