The European Union (EU) has published a draft regulation to revise Annex XVII of REACH (Registration, Evaluation, Authorization and Restriction of Chemicals). Annex XVII relates to restrictions on the manufacturing, placing onto the market, and use of certain dangerous substances, mixtures, and articles.
The proposed changes include the deletion of the following entries:
• 22 – pentachlorophenol (PCP)
• 67 – decabromodiphenyl ether (DecaBDE)
• 68 – perfluorooctanoic acid (PFOA) and its salts, and PFOA-related substances
Entries 22 and 67 are now regulated under Regulation (EU) 2019/2021 on persistent organic pollutants (POP Recast), and Entry 68 will be regulated under the POP Recast by amendment.
Other important changes include:
• 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. The updated list includes:
o 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
o EN ISO 17234-2:2011 – Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 2: Determination of 4-aminoazobenzene
o 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
o 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
The EU’s draft regulation was circulated by the World Trade Organization (WTO) on April 23, 2020, attached to WTO document number 20-3204. If accepted, the proposal will be adopted in Q4 with a date of entry into force 20 days after publication in the Official Journal of the EU. Its provisions will be implemented in phases.
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