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)
- 22 – pentachlorophenol (PCP, its salts and esters)
- 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
- EN ISO 17234-1:2015 Leather – Chemical tests for the determination
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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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