Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs: Executive summary

Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Alfred Francois Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Franz Roland, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá,, Detlef Wölfle , Holger ZornEFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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Abstract

This opinion describes the assessment of the risks to public health associated with bisphenol A (BPA) exposure. Exposure was assessed for various groups of the human population in three different ways: (1) external (by diet, drinking water, inhalation, and dermal contact to cosmetics and thermal paper); (2) internal exposure to total BPA (absorbed dose of BPA, sum of conjugated and unconjugated BPA); and (3) aggregated (from diet, dust, cosmetics and thermal paper), expressed as oral human equivalent dose (HED) referring to unconjugated BPA only. The estimated BPA dietary intake was highest in infants and toddlers (up to 0.875 µg/kg bw per day). Women of childbearing age had dietary exposures comparable to men of the same age (up to 0.388 µg/kg bw per day). The highest aggregated exposure of 1.449 µg/kg bw per day was estimated for adolescents. Biomonitoring data were in line with estimated internal exposure to total BPA from all sources. BPA toxicity was evaluated by
a weight of evidence approach. “Likely” adverse effects in animals on kidney and mammary gland underwent benchmark dose (BMDL10) response modelling. A BMDL10 of 8 960 µg/kg bw per day was calculated for changes in the mean relative kidney weight in a two generation toxicity study in mice. No BMDL10 could be calculated for mammary gland effects. Using data on toxicokinetics, this BMDL10 was converted to an HED of 609 µg/kg bw per day. The CEF Panel applied a total uncertainty factor of 150 (for inter- and intra-species differences and uncertainty in mammary gland, reproductive, neurobehavioural, immune and metabolic system effects) to establish a temporary Tolerable Daily Intake (t-TDI) of 4 µg/kg bw per day. By comparing this t-TDI with the exposure estimates, the CEF Panel concluded that there is no health concern for any age group from dietary exposure or from aggregated exposure. The CEF Panel noted considerable uncertainty in the exposure estimates for non-dietary sources, whilst the uncertainty around dietary estimates was relatively low.
Original languageEnglish
Pages3978
Number of pages23
Volume13
No.1
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - 25 Mar 2015

Bibliographical note

Adopted 11 December 2014

Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Franz Roland, Vittorio
Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn.

Acknowledgement: The Panel wishes to thank the members of the Working Groups on BPA Exposure and Toxicology: Claire Beausoleil, Diane Benford, Emma Bradley, Anne Lise Brantsaeter, Gemma Calamandrei, Daniel Doerge, Paul Fowler, Peter Greaves (until July 2012), Ursula Gundert-Remy, Andrew David Hart, Edel Holene, Trine Husøy, Catherine Leclercq (until July 2013), Inger Therese Laugsand Lillegaard, Wim Mennes, Ralph Pirow, Maria de Fátima Tavares Poças, Iona Pratt (deceased in February 2014), Josef Rudolf Schlatter, Catherine Simoneau, Wout Slob, Jacqueline Van Engelen, Henk Van Loveren, Natalie Von Götz, Detlef Wölfle and Rudolf Antonius Woutersen for the preparatory work on this scientific opinion and the hearing experts: Jan Alexander, Pasquale Mosesso and Alfonso Siani, and EFSA staff: Davide Arcella, Anna F. Castoldi, Cristina Croera and Anne Theobald for the support provided to this scientific opinion.

Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2015. Scientific Opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs: Executive summary. EFSA Journal 2015;13(1):3978, 22 pp. doi:10.2903/j.efsa.2015.3978

Keywords

  • bisphenol A
  • BPA
  • exposure
  • toxicity
  • health risks
  • TDI
  • food contact materials

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