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Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10113887/ https://www.ncbi.nlm.nih.gov/pubmed/37089179 http://dx.doi.org/10.2903/j.efsa.2023.6857 |
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author | Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Chesson, Andrew Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Silano (until 21 December 2020†), Vittorio Steffensen, Inger‐Lise Tlustos, Christina Vernis, Laurence Zorn, Holger Batke, Monika Bignami, Margherita Corsini, Emanuela FitzGerald, Rex Gundert‐Remy, Ursula Halldorsson, Thorhallur Hart, Andrew Ntzani, Evangelia Scanziani, Eugenio Schroeder, Henri Ulbrich, Beate Waalkens‐Berendsen, Dina Woelfle, Detlef Al Harraq, Zainab Baert, Katleen Carfì, Maria Castoldi, Anna F Croera, Cristina Van Loveren, Henk |
author_facet | Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Chesson, Andrew Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Silano (until 21 December 2020†), Vittorio Steffensen, Inger‐Lise Tlustos, Christina Vernis, Laurence Zorn, Holger Batke, Monika Bignami, Margherita Corsini, Emanuela FitzGerald, Rex Gundert‐Remy, Ursula Halldorsson, Thorhallur Hart, Andrew Ntzani, Evangelia Scanziani, Eugenio Schroeder, Henri Ulbrich, Beate Waalkens‐Berendsen, Dina Woelfle, Detlef Al Harraq, Zainab Baert, Katleen Carfì, Maria Castoldi, Anna F Croera, Cristina Van Loveren, Henk |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10113887 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-101138872023-04-20 Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Chesson, Andrew Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Silano (until 21 December 2020†), Vittorio Steffensen, Inger‐Lise Tlustos, Christina Vernis, Laurence Zorn, Holger Batke, Monika Bignami, Margherita Corsini, Emanuela FitzGerald, Rex Gundert‐Remy, Ursula Halldorsson, Thorhallur Hart, Andrew Ntzani, Evangelia Scanziani, Eugenio Schroeder, Henri Ulbrich, Beate Waalkens‐Berendsen, Dina Woelfle, Detlef Al Harraq, Zainab Baert, Katleen Carfì, Maria Castoldi, Anna F Croera, Cristina Van Loveren, Henk EFSA J Scientific Opinion 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. John Wiley and Sons Inc. 2023-04-19 /pmc/articles/PMC10113887/ /pubmed/37089179 http://dx.doi.org/10.2903/j.efsa.2023.6857 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Chesson, Andrew Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Silano (until 21 December 2020†), Vittorio Steffensen, Inger‐Lise Tlustos, Christina Vernis, Laurence Zorn, Holger Batke, Monika Bignami, Margherita Corsini, Emanuela FitzGerald, Rex Gundert‐Remy, Ursula Halldorsson, Thorhallur Hart, Andrew Ntzani, Evangelia Scanziani, Eugenio Schroeder, Henri Ulbrich, Beate Waalkens‐Berendsen, Dina Woelfle, Detlef Al Harraq, Zainab Baert, Katleen Carfì, Maria Castoldi, Anna F Croera, Cristina Van Loveren, Henk Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs |
title | Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs |
title_full | Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs |
title_fullStr | Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs |
title_full_unstemmed | Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs |
title_short | Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs |
title_sort | re‐evaluation of the risks to public health related to the presence of bisphenol a (bpa) in foodstuffs |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10113887/ https://www.ncbi.nlm.nih.gov/pubmed/37089179 http://dx.doi.org/10.2903/j.efsa.2023.6857 |
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