Re�evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs
EFSA Journal · 36 authors
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This EFSA re-evaluation of bisphenol A (BPA) established a new tolerable daily intake (TDI) of 0.2 ng/kg bw per day, a 20,000-fold reduction from the previous temporary TDI of 4 µg/kg bw per day. The critical effect was an increase in Th17 cell percentage in mice, with a benchmark dose lower confidence limit (BMDL) of 8.2 ng/kg bw per day (human equivalent dose). The Panel concluded that dietary BPA exposure exceeds the new TDI by two to three orders of magnitude for all age groups, raising a health concern.
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**Background:** Bisphenol A (BPA) is a monomer used in polycarbonate plastics and epoxy resins for food contact materials. In 2015, EFSA established a temporary tolerable daily intake (t-TDI) of 4 µg/kg bw per day, concluding no health concern from dietary exposure. The European Commission mandated EFSA to re-evaluate BPA risks and establish a full TDI based on new evidence, including the US NTP CLARITY-BPA study.
**Methods:** The re-evaluation followed a systematic protocol with critical appraisal and weight of evidence (WoE) assessment. Literature from 1 January 2013 to 15 October 2018 was considered (extended to 21 July 2021 for genotoxicity). A total of 810 studies were appraised or narratively reviewed. Health outcome categories (HOCs) included general toxicity, immunotoxicity, metabolic effects, neurotoxicity, reproductive/developmental toxicity, cardiotoxicity, carcinogenicity, and genotoxicity. Benchmark dose (BMD) analysis was performed for endpoints rated Likely or Very Likely. A structured uncertainty analysis using expert knowledge elicitation quantified the combined impact of uncertainties.
**Key Results:** The Panel identified the immune system as the most sensitive target. The critical effect was an increase in Th17 cell percentage in mice (Luo et al., 2016). After conversion to human equivalent dose (HED), the lowest BMDL was 8.2 ng/kg bw per day. Other endpoints with BMDLs only slightly higher (up to 7-fold) included ovarian follicle ratio, sperm motility, and uric acid. Likely effects were also identified for allergic lung inflammation, cellular immunity, inflammation, uric acid, neuromorphology, nervous system functionality, behaviour, female reproductive toxicity, male reproductive toxicity, and uterus histology. The uncertainty analysis showed a 57-73% probability (averaged across experts) that the true lowest BMD for relevant/adverse effects is below the reference point of 8.2 ng/kg bw per day. An additional uncertainty factor of 2 was applied. The overall uncertainty factor was 50 (2.5 for interspecies toxicodynamics × 10 for intraspecies variability × 2 for additional uncertainties), yielding a TDI of 0.2 ng/kg bw per day. BPA was not considered a genotoxic hazard via a direct DNA mechanism, allowing a health-based guidance value to be established.
**Clinical Implications:** The new TDI of 0.2 ng/kg bw per day is 20,000-fold lower than the 2015 t-TDI. Dietary exposure estimates from 2015 exceed this TDI by two to three orders of magnitude for all age groups. The Panel concluded there is a health concern from dietary BPA exposure for the entire general population. This assessment did not include an updated exposure analysis, but the magnitude of exceedance is considered sufficient to warrant concern despite this uncertainty.