European Food Safety Authority (EFSA)

On April 19, 2023, the European Food Safety Authority (EFSA) released its revised final report on BPA safety titled “Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs.” The report was prepared by EFSA’s panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids.

EFSA’s 2015 assessment on BPA concluded: “there is no health concern for any age group from dietary exposure and low health concern from aggregated exposure.” In the 2023 final opinion, EFSA reversed its previous position and “concluded that there is a health concern from dietary BPA exposure.” The final opinion uses a different approach than what was previously used by EFSA, and does not take all available and relevant evidence into account–a significant difference from established weight of evidence approaches used by risk assessment authorities around the world.

The 2015 report set the temporary Tolerable Daily Intake (t-TDI), the estimated exposure limit for BPA that can be consumed over a lifetime without appreciable risk, to 4 micrograms (4 millionths of a gram) per kilogram of body weight per day, while this final report sets it at 0.2 nanograms per kilogram of body weight per day.

EFSA’s new position is at odds with other scientific conclusions.

In fact, EFSA’s final report is in contrast to diverging opinions of the European Medicines Agency (EMA) and the German Federal Institute for Risk Assessment (BfR) that were published shortly after. Both authorities point at key shortcomings of the EFSA opinion on BPA, and as a result they do not support the newly derived TDI.

Furthermore, in 2018, the U.S. Food and Drug Administration (FDA) published its findings from the CLARITY Core Study, the largest study ever conducted to study the full range of potential health effects from exposure to BPA and found no adverse health effects from BPA at typical consumer exposure levels. Other agencies from around the world have published similar conclusions on BPA, including Health Canada, the Food Standards Australia New Zealand, and the Japanese National Institute of Advanced Industrial Science and Technology.

BPA is one of the most widely studied chemicals used today. EFSA’s new opinion is contradicted by the weight of scientific evidence presented by various international regulatory bodies.

Click here to read recent commentary published in the Society of Toxicology’s Toxicological Sciences journal in which the authors note, “The EFSA hazard assessment review process is not scientifically sound and has led to a conclusion that there are low-dose effects based on very few, lower quality experimental animal studies. These effects and the conclusions drawn are not sufficiently supported by the totality of the available evidence, which includes multiple high quality studies not considered in EFSA’s recent review.”