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NEA newsletter-202310

Latest Progress in Environmental Protection Laws and Regulations, Product Recall Case, and Experts Q&A

Germany withdraws EU-wide BP-wide restrictions on BPS
Germany has withdrawn its proposal on EU group restriction of bisphenols (BPA, BPB, BPS, BPF and BPAF) following comments to the six-month public consultation. The first time a dossier submitter has taken such action. The German Federal Institute for Occupational Safety and Health (BAuA) acted before ECHA's committees prepared their opinions. BAuA is expected to submit an updated proposal once it has considered information collected during the consultation and "reworked the scope", according to an ECHA announcement on 30 August. Once amended, BAuA will resubmit the proposal to ECHA. The dossier will be subjected to a new consultation and scrutiny by the Risk Assessment Committee (RAC) and the Socioeconomic Analysis Committee (SEAC). BAuA has not given ECHA a timetable for resubmission.

The proposed restriction faced opposition from various quarters following its release.

  • Producers of polycarbonates and textiles complained in February that the lower concentration limits are not feasible for their sectors because of more frequent tests and higher associated costs.
  • The plastics recycling sector said it could hit particularly hard by testing costs, which could reach €15,000 per model of finished article.
UK Proposes Revision to GB CLP Regulation on Substances and Mixtures
On August 24, 2023, the World Trade Organization (WTO) announced a proposal from the United Kingdom (UK) Government to revise its Great Britain (GB) mandatory classification and labelling list (GB MCL list), an important directory for the classification and labelling of substances and mixtures for GB-based manufacturers, importers, downstream users and distributors supplying the GB market.
The proposed revision, attached to WTO document 23-5712 and notified under G/TBT/N/GBR/67, contains several important changes to the GB MCL list. It:
  • Adds and revises 26 entries of substances, including the introduction of bisphenol AF (BPAF, CAS 1478-61-1) – a reprotoxic cate-gory 1B substance.
  • Adds new entry for '2-ethylhexanoic acid and its salts with the exception of those specified elsewhere in this list' with a note indicating, in part, that the classification for the hazard class(es) in this entry is based only on the hazardous properties of the part of the substance which is common to all substances in the entry.
According to the WTO notification, it is expected the draft amendment will be:
  • Adopted in Q1 of 2024
  • Enter into force in Q1 of 2024
  • Become a legal requirement in Q3 of 2025
Transition period ends for REACH restriction on diisocyanates
On 4 August 2020, the European Union issued (EU) 2020/1149, adding a restriction to Article 74 for diisocyanates (substances with the structure O=C=N-R-N=C=O, where R is an aliphatic or aromatic structural unit of unspecified length). Diisocyanates is mainly used to make polyurethane products, such as rigid and flexible foams, coatings, adhesives, sealants and elastomers. Diisocyanates shall not be used as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 August 2023, unless:
(a) the concentration of diisocyanates individually and in combination is less than 0,1 % by weight, or (b) the employer or self-employed ensures that industrial or professional user(s) have successfully completed training on the safe use of diisocyanates prior to the use of the sub-stance(s) or mixture(s).

NGOs push US EPA to ban harmful substances in plastic

Environmental groups have urged the US EPA to harness its TSCA authorities to collect information on chemicals in plastic manufacturing and prohibit the use of those determined to be harmful. The NGO input addresses the agency's national strategy to prevent plastic pollution which was drafted 2023 spring. The document outlines non-binding ways to stop plastic-related environmental contamination by 2040 — in line with ongoing global efforts to establish a treaty to end plastic pollution. Dozens of groups have called on the agency to go further and use TSCA to prohibit the use of concerning substances in the plastics sector, compel manufacturers to report on and test them, and comprehensively account for cumulative risks and exposures to the community.

The Netherlands adds more than 80 entries to national SVHC list
The Dutch National Institute for Public Health and the Environment (RIVM) has added more than 80 entries for individual or groups of chemicals to its substances of very high concern (ZZS) list. It is the second review of the list this year, carried out on 24 August, and includes the following additions: 
  • bis(4-chlorophenyl)sulfone;
  • diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide;
  • hydrocarbons, C10-C13, aromatics, <1% naphthalene;
  • disodium 4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo] naphthalene-2,7-disulfonate;
  • 3-bromobiphenyl;
  • 4,4'-dibromobiphenyl;
  • 4-bromobiphenyl;
  • nonabromo-1,1'-biphenyl;
  • tetrabromo(tetrabromophenyl)benzene.

The ZZS list contains chemicals meeting the criteria of REACH article 57 on substances to be included on the authorisation list (Annex XIV) and those under other EU regulations and UN conventions.

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