On April 6 2022, ECHA and the Member States have assessed a group of 148 bisphenols and recommended that more than 30 bisphenols need to be restricted due to their potential hormonal or reprotoxic effects.
Many bisphenols are known endocrine disrupters both for human health and the environment and may lead to exposures to both professionals and consumers.
Bisphenols are mostly used as intermediates in the manufacture of polymers or polymer resins, such as polycarbonate plastics and epoxy resins and hardeners. They are also used in thermal paper, inks and coatings, adhesives, textiles, paper or in board. As they are widely used, a group restriction has been identified as the best way to manage the risks of 34 bisphenols.
Three bisphenols (bisphenol A, bisphenol B and 2,2-bis (4’-hydroxyphenyl)-4-methylpentane) have already been identified as substances of very high concern (SVHCs). However, for many group members, more data needs to be generated before potential endocrine-disrupting and reprotoxic properties can be confirmed.
German authorities are already preparing a proposal to restrict the use of bisphenol A and other bisphenols with endocrine-disrupting properties for the environment. Once it is clearer which bisphenols the German proposal will cover, ECHA and the European Commission will consider any further needs for regulatory action on bisphenols.
What is Group Assessment?
To speed up the identification of chemicals that need regulatory action, authorities may decide to address them in groups of structurally related substances rather than as single substances.
This grouping approach:
- Brings consistency and improves the coherence of regulatory work.
- Makes it faster to identify substances that need regulatory action as well as those for which no further action is needed at this stage.
- Supports informed substitution by industry. Substances registered for intermediate uses only, or those not currently registered but which could be potential substitutes for known substances of concern, are also identified early on.
Germany’s proposal to restrict bisphenol A and structurally-related bisphenols
A) Restricting the use as an additive and the content in articles (0.02% by weight).
B) Restricting content of residues (unreacted monomer) in articles – also for imported goods (0.02% by weight).
C) Restricting the use of mixtures with content of 0.02% by weight for industrial and professional uses where strictly controlled conditions cannot be assured, e.g. in non-automated processes and for consumer uses.
D) Introducing release rates for BPA from articles (products and subassemblies) during service life (weathering, leaching due to cleaning action) preventing release into the environment and/or (direct) migration to organisms.
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