The European Union (EU) has published Regulation (EU) 2020/2096, which makes several changes to Annex XVII of Regulation (EC) 1907/2006 on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
Published on December 16, 2020, the new law relates to ‘Restrictions on the manufacturing, placing on the market and use of certain dangerous substances, mixtures and articles’. Among the changes brought in by Regulation (EU) 2020/2096, stakeholders should be aware:
- Entries deleted:
- 22 – pentachlorophenol (PCP, its salts and esters)
- 67 – decabromodiphenyl ether (Deca-BDE)
- 68 – perfluorooctanoic acid (PFOA) and its salts, and PFOA-related substances (these are now regulated under Regulation (EU) 2019/1021 on persistent organic pollutants (POP Recast Regulation)
- Language edited to align with Regulation (EC) 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation), including hazard statements
- Devices falling under Regulation (EU) 2017/745 (Medical Devices) are exempted from entries 28 to 30 on carcinogenic, mutagenic or reproductive category 1A and 1B substances (CMR category 1A and 1B substances)
- CMR category 1A and/or 1B substances are added to entries 28 to 30 to align with the CLP Regulation, including cobalt, three polycyclic aromatic hydrocarbons (PAHs) and diisohexyl phthalate (DIHP)
- CAS and EC numbers deleted from entry 46 (nonylphenol, NP) as the scope covers all isomers of NP
- List of harmonized standards in Appendix 10 for demonstrating
compliance with azo colorants replaced. Harmonized standards include:
- 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 17234-1:2011 Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 2: Determination of 4-aminoazobenzene
- 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 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
Stakeholders should be aware of the following dates:
- July 2020 – deletion of entry 68 to Annex XVII of REACH (PFOA and its salts, and PFOA-related substances)
- July 5, 2021 and October 1, 2021 – provisions in Points (8)(b), (11)(b) and (12)(b) under Article 2 implemented
- January 5, 2021 – provisions not mentioned above implemented
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