After re-evaluating the potential health risks of bisphenol A (BPA) in plastics used in food contact products such as packaging, the European Food Safety Authority (EFSA, Parma, Italy; www.efsa.europa.eu) is considering drastically cutting its guidance for the tolerable daily intake (TDI) of the substance by a factor of 100,000. The material can be found in polycarbonate and epoxy resins.

A draft scientific opinion from the agency’s Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) would establish a new TDI recommendation of 0.04 ng/kg of body weight. The proposal is on the EFSA website and open for comments until 22 February 2022. A 24 January meeting of technical experts was held to discuss the change, the results of which are also due to be presented on the website.

EFSA’s new guideline updates its controversial 2015 risk assessment that set a temporary TDI for BPA at 4 µg/kg of body weight. The EU body said the proposed change follows an evaluation of studies published between 2013 and 2018 that point to adverse effects the additive can have on the immune system.

“The new studies helped us address important uncertainties about BPA’s toxicity,” said Claude Lambré, the CEP panel’s chair. Animal studies, the experts found, showed a rise in the number of T-cells, which play a key role in cellular immune mechanisms and could lead to the development of allergic lung inflammation.

Prior to revising its guidance, EFSA said it published and tested the safety protocols in 2017 and in 2019, leveraging the work of the CLARITY-BPA project developed in the US by the National Institute of Environmental Health Sciences (NIEHS) and the Food and Drug Administration (FDA, www.fda.gov), in cooperation with the National Toxicology Program (NTP). It also consulted with the European Chemicals Agency (ECHA, Helsinki; www.echa.europa.eu) and national scientific advisory bodies in EU member states.

BPA’s role as a possible endocrine disruptor has been under observation worldwide for over a decade, but EFSA, supported by plastics industry organisations, was long reluctant to consider dropping its recommended TDI. In 2006, the agency set the threshold at 50 µg/kg of body weight, reconfirming this in 2008 and 2010 (see Plasteurope.com of 07.10.2010). While the advisory panel at the time acknowledged studies suggesting possible adverse effects on animals at doses well below existing recommendations, it said the research had “many shortcomings.”

The panel similarly identified “likely adverse effects” of BPA on the liver, kidney and mammary gland in humans; however, in early 2014 EFSA said it still believed the risks were “manageable” (see Plasteurope.com of 22.01.2014). With the health agency firmly on the fence, the EU Commission nevertheless banned the use of the chemical in baby bottles in 2011.

The EU is still well ahead of the US in cutting acceptable BPA levels in food and other applications, reports show. In 1988, the FDA set the safe daily exposure level at 50 µg/kg of body weight, where it remains.

Commenting on EFSA’s proposal, Pete Myers, chief scientist for Environmental Health Sciences, publisher of the journal Environmental Health News, said the divide between regulators in Europe and the US regarding BPA’s toxicity “is going to provoke major challenges in trade and commerce, along with fundamental questions about what US regulators are doing.”

In a year-long investigation, the journal said it found that the FDA “has stacked the deck against findings from independent scientists studying BPA and other compounds substituted in products claimed to be BPA-free.” Among other things, it said the research showed that FDA and industry scientists “continue to use decades-old study methods that fail to detect effects known to be associated with BPA.”