In 2015, EFSA established a temporary tolerable daily intake (t-TDI) for BPA of 4 μg/kg body weight (bw) per day. In 2016, the European Commission mandated EFSA to re-evaluate the risks to public health from the presence of BPA in foodstuffs and to establish a tolerable daily intake (TDI). For this re-evaluation, a pre-established protocol was used that had undergone public consultation. The CEP Panel concluded that it is Unlikely to Very Unlikely that BPA presents a genotoxic hazard through a direct mechanism. Taking into consideration the evidence from animal data and support from human observational studies, the immune system was identified as most sensitive to BPA exposure. An effect on Th17 cells in mice was identified as the critical effect; these cells are pivotal in cellular immune mechanisms and involved in the development of inflammatory conditions, including autoimmunity and lung inflammation. A reference point (RP) of 8.2 ng/kg bw per day, expressed as human equivalent dose, was identified for the critical effect. Uncertainty analysis assessed a probability of 57–73% that the lowest estimated Benchmark Dose (BMD) for other health effects was below the RP based on Th17 cells. In view of this, the CEP Panel judged that an additional uncertainty factor (UF) of 2 was needed for establishing the TDI. Applying an overall UF of 50 to the RP, a TDI of 0.2 ng BPA/kg bw per day was established. Comparison of this TDI with the dietary exposure estimates from the 2015 EFSA opinion showed that both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude. Even considering the uncertainty in the exposure assessment, the exceedance being so large, the CEP Panel concluded that there is a health concern from dietary BPA exposure.

Lambre, C., Barat Baviera, J. M., Bolognesi, C., Chesson, A., Cocconcelli, P. S., Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Riviere, G., Silano, V., Steffensen, I. -., Tlustos, C., Vernis, L., Zorn, H., Batke, M., Bignami, M., Corsini, E., Fitzgerald, R., Gundert-Remy, U., Halldorsson, T., Hart, A., Ntzani, E., Scanziani, E., Schroeder, H., Ulbrich, B., Waalkens-Berendsen, D., Woelfle, D., Al Harraq, Z., Baert, K., Carfi, M., Castoldi, A. F., Croera, C., Van Loveren, H., Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs, <<EFSA JOURNAL>>, 2023; 21 (4): N/A-N/A. [doi:10.2903/j.efsa.2023.6857] [https://hdl.handle.net/10807/258721]

Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs

Cocconcelli, Pier Sandro;Silano, Vittorio;
2023

Abstract

In 2015, EFSA established a temporary tolerable daily intake (t-TDI) for BPA of 4 μg/kg body weight (bw) per day. In 2016, the European Commission mandated EFSA to re-evaluate the risks to public health from the presence of BPA in foodstuffs and to establish a tolerable daily intake (TDI). For this re-evaluation, a pre-established protocol was used that had undergone public consultation. The CEP Panel concluded that it is Unlikely to Very Unlikely that BPA presents a genotoxic hazard through a direct mechanism. Taking into consideration the evidence from animal data and support from human observational studies, the immune system was identified as most sensitive to BPA exposure. An effect on Th17 cells in mice was identified as the critical effect; these cells are pivotal in cellular immune mechanisms and involved in the development of inflammatory conditions, including autoimmunity and lung inflammation. A reference point (RP) of 8.2 ng/kg bw per day, expressed as human equivalent dose, was identified for the critical effect. Uncertainty analysis assessed a probability of 57–73% that the lowest estimated Benchmark Dose (BMD) for other health effects was below the RP based on Th17 cells. In view of this, the CEP Panel judged that an additional uncertainty factor (UF) of 2 was needed for establishing the TDI. Applying an overall UF of 50 to the RP, a TDI of 0.2 ng BPA/kg bw per day was established. Comparison of this TDI with the dietary exposure estimates from the 2015 EFSA opinion showed that both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude. Even considering the uncertainty in the exposure assessment, the exceedance being so large, the CEP Panel concluded that there is a health concern from dietary BPA exposure.
2023
Inglese
Lambre, C., Barat Baviera, J. M., Bolognesi, C., Chesson, A., Cocconcelli, P. S., Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Riviere, G., Silano, V., Steffensen, I. -., Tlustos, C., Vernis, L., Zorn, H., Batke, M., Bignami, M., Corsini, E., Fitzgerald, R., Gundert-Remy, U., Halldorsson, T., Hart, A., Ntzani, E., Scanziani, E., Schroeder, H., Ulbrich, B., Waalkens-Berendsen, D., Woelfle, D., Al Harraq, Z., Baert, K., Carfi, M., Castoldi, A. F., Croera, C., Van Loveren, H., Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs, <<EFSA JOURNAL>>, 2023; 21 (4): N/A-N/A. [doi:10.2903/j.efsa.2023.6857] [https://hdl.handle.net/10807/258721]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/258721
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