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Bisphenol B, an endocrine disruptor for humans and the environment

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News of 09/03/2021

Some countries outside the European Union use bisphenol B as an alternative to bisphenol A, a substance whose endocrine-disrupting properties are now widely recognised. However, bisphenol B has similar, or even slightly greater, endocrine-disrupting properties. Following the identification of these properties, ANSES is proposing to identify bisphenol B as a substance of very high concern under the European REACh Regulation, like bisphenol A. The purpose of this classification is to prevent the industrial usage of this chemical on the European continent as a replacement for bisphenol A, and to require importers of consumer goods to declare its presence in concentrations exceeding a threshold of 0.1%.


Bisphenol B, an endocrine disruptor for humans and the environment 

ANSES assessed the endocrine-disrupting potential of bisphenol B as part of the French national endocrine disruptor strategy. Based on the scientific data available, ANSES has established that this substance meets all the hazard criteria necessary for it to be defined as an endocrine disruptor according to the WHO definition and the 2013 recommendations of the European Commission, namely:

  • Endocrine activity: bisphenol B has an oestrogenic action in that it increases the production of oestrogens – female hormones – and activates oestrogen receptors;
  • Harmful effects by altering the male reproductive system: lower daily sperm production, a reduction in the relative weight of the male reproductive organs;
  • A biologically plausible link between endocrine activity and the adverse effects above. 

These effects, which are observed consistently in rodents and fish, are similar or even slightly greater at an equivalent dose, than those of bisphenol A, already identified in Europe as an endocrine disruptor. Bisphenol B can thus have serious effects on human health and alter species stability in the environment. 
In addition, the effects of exposure to bisphenol B could be cumulated with those of other bisphenols with similar properties, such as bisphenols A and S, to which humans and the environment may also be exposed. The analogy with bisphenol A, which has been studied far more extensively, points to the likelihood of bisphenol B inducing other effects, on female reproduction or metabolism for example, and impacting a significant number of species in the environment.


Preventing the undesirable replacement of bisphenol A by bisphenol B

Bisphenol B is currently used as an alternative for some uses of bisphenol A and bisphenol S in a number of countries, particularly in the United States, where it has been registered as an indirect additive used in certain food-contact coatings and polymers. Although not registered under the REACh Regulation for manufacture or use as a chemical in Europe, it has been found in biological samples from European populations as well as in environmental media in China. 

The endocrine-disrupting properties of bisphenol B are of sufficient concern within the definition of the REACh Regulation for ANSES to propose identifying it as a substance of very high concern (SVHC).

The purpose of this identification is to prevent the development of the use or manufacture of bisphenol B as a replacement for bisphenol A. It will also require importers of consumer goods to declare its presence in concentrations exceeding a threshold of 0.1%.
The identification dossier proposed by ANSES is available for public consultation on the website of the European Chemicals Agency (ECHA) until 23 April. 
This approach may also be extended to other bisphenols whose chemical structures and effects are similar to those of bisphenols A and B