On April 19, 2023, the European Food Safety Authority (EFSA) published its final Scientific Opinion on bisphenol A (BPA, 80-05-7), correcting its earlier draft Scientific Opinion from 2015 (FPF reported). In this latest risk assessment report, EFSA concludes that “there is a health concern from dietary BPA exposure” because “dietary exposures in all age groups exceeded the TDI [tolerable daily intake] by two to three orders of magnitude.” This finding is based on a new TDI of 0.2 ng/kg bodyweight (bw) per day, established by the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP).
In the assessment from 2015, EFSA’s CEP Panel had recommended a temporary TDI (t-TDI) of 4000 ng/kg bw/day (or, 4µg/kg bw/d), based on the available but, at the time, uncertain knowledge. Following extensive work on establishing the safety of BPA carried out in the United States under the BPA CLARITY program in 2020 (FPF reported), EFSA re-evaluated the available science on BPA and its health impacts from dietary exposure. In December 2021, EFSA published a draft Scientific Opinion setting the TDI of BPA at 0.04 ng/kg/day based on its impacts on the immune system (FPF reported). The TDI EFSA has now published is 5 times higher but still a 20 000-fold decrease from the t-TDI established in 2015.
It is unclear how the new TDI will be reflected in European Union regulations on food contact materials (FCMs). The EU Commission is revising its FCM regulations (FPF reported also here), but a new regulatory proposal is not expected to be ready until late 2024 or early 2025. Currently, the use of BPA in FCMs is authorized for plastics, varnishes, and coatings with a specific migration limit (SML) of 0.05 mg/kg food, excluding FCMs intended for infants where BPA is not allowed to be used (FPF reported). This SML was based on the t-TDI, but also took other exposure sources than FCMs into account.
Reference
EFSA CEP Panel (April 19, 2023). “Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs.” EFSA Journal
EFSA (April 19, 2023). “Bisphenol A in food is a health risk.”
Read more
EFSA and the European Medicines Agency (April 19, 2023). “Report on divergent views between EFSA and EMA on EFSA’s updated bisphenol A assessment.” EFSA (pdf).
EFSA and the German Federal Institute for Risk Assessment (April 19, 2023). “Report on diverging views between EFSA and BfR on EFSA updated bisphenol A assessment.” EFSA (pdf).
Emma Davies (April 20, 2023). “Germany’s federal risk assessment body rejects Efsa’s safe limit for BPA.” Chemical Watch
Tom Neltner and Maricel Miffini (April 19, 2023). “European Food Safety Authority reaffirms that BPA uses for food are not safe. Where is FDA?” Environmental Defense Fund
Cailey Gleeson (April 26, 2023). “US FDA studying Efsa assessment that lowers BPA safe limit.” Chemical Watch
