EU Health Bodies at Odds on Safe Levels of Bisphenol A, Industry Awaits Decision

Europe: The European Food Safety Authority (EFSA) has proposed a significant reduction in the safe level of Bisphenol A (BPA) to 0.2ng/kg of body weight per day, compared to the 4µg level set in 2015. BPA is used to make polycarbonate plastics and Epoxy resins commonly found in food containers and drinks cans but has been identified as an endocrine disruptor. The EFSA assessed a 'vast' number of papers, including 800 published since 2013, identifying potential harmful effects on the immune system based on both animal and human observational studies. The European Medicines Agency (EMA) has stated that it requires further evidence before considering such a reduction.

The EFSA's panel on food contact materials, enzymes and processing aids highlighted a research study that observed an increase in Th17 white blood cells in mice's spleens. This could potentially result in autoimmune disorders and allergic lung inflammation. The study's critical effect was found at a dose of 8.2ng/kg of body weight per day, with additional health effects seen at lower doses. The EFSA experts took interspecies differences and human variability into account and applied an uncertainty factor of 50, which lowered the exposure level to 0.2ng/kg body weight.

The European Medicines Agency (EMA) does not support the proposal of lowering the safe exposure level for Bisphenol-A (BPA). The agency questions the evidence of a causal link between BPA, an increase in white blood cells, and asthma, and it also scrutinizes the extrapolation of data from animal studies to humans, used by the European Food Safety Authority (EFSA). As the EFSA's advice is reviewed by the European Commission, lawmakers will decide whether to implement more restrictions on BPA in food contact materials.

The European Commission is set to revise their regulations on food contact materials after an assessment revealed that proposed safe levels of Bisphenol A (BPA) are so low that routine enforcement would be challenging due to the limitations of available analytical methods. As a result, the question of whether the proposed limit amounts to a de-facto ban on BPA is debatable. The assessment has also prompted the commission to include BPA, along with over 140 other Bisphenols on the EU market, in their restriction’s roadmap announced last year, which aims to ban these substances.

Proposals by the Commission cover only five Bisphenols, including widely used BPA and its substitute, BPF. However, the main uses of these chemicals are exempted. According to recent scientific findings, these Bisphenols possess similar properties. Therefore, the Commission will propose a restriction for the whole group to prevent any regrettable substitutions.

There are ongoing risk assessments of Bisphenols. The UK’s Food Standards Agency is scrutinizing tetra-methyl Bisphenol F Diglycidyl Ether (TMBPF-DGE), an alternative to BPA in can coatings. The agency's recommendation is expected later this year.