Scientific Opinion on Bisphenol A: evaluation of a study investigating its neurodevelopmental toxicity, review of recent scientific literature on its toxicity and advice on the Danish risk assessment of Bisphenol A

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Acknowledgements

The Panel wishes to thank the members of the Working Groups on Bisphenol A: David Bell (resigned on 15 January 2010), Wilfried Bursch, Berit Granum, Ulla Hass (her participation was limited to the evaluation of the Stump study until 26 March 2010), Edel Holene, Trine Husøy, Alberto Mantovani, Wim Mennes, Unni Cecilie Nygaard, Terry Parker, Ulrike Reuter, Emanuela Testai, Rosemary Waring, Detlef Wölfle for the preparatory work on this scientific opinion and EFSA staff: Anna F. Castoldi, Saghir Bashir, Laura Ciccolallo, Cristina Croera, Tomas Oberg, Roberta Pinalli Anne Theobald and Didier Verloo for the support provided to this scientific opinion.

Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2010; 8(9):1829 [116 pp.].
doi
10.2903/j.efsa.2010.1829
Panel members at the time of adoption
Arturo Anadón, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertlé, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldrá, Rosemary Waring, Detlef Wölfle.
Minority Opinion
Part of this Opinion is not shared by a member of the Panel, Catherine Leclercq, who expressed a Minority Opinion related to parts II and IV (Overall conclusions) of this opinion.
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2009-00864
EFSA-Q-2010-01023
EFSA-Q-2010-00709
Adopted
23 September 2010
Published
30 September 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Bisphenol A (BPA) is used in the manufacture of plastics, to produce reusable drinking bottles, infant feeding bottles and other food storage containers. EFSA was asked to evaluate a dietary developmental neurotoxicity study in rats (Stump, 2009) and recent scientific literature (2007-2010) in terms of relevance for the risk assessment of BPA. The impact of these studies on the current Tolerable Daily Intake (TDI) of 0.05 mg BPA/kg body weight (b.w.)/day as set by EFSA in 2006 was assessed. Advice on the Danish risk assessment underlying the Danish ban of BPA in food contact materials for infants aged 0-3 years is included. Overall, based on this comprehensive evaluation of recent toxicity data, the Panel on food contact materials, enzymes, flavourings and processing aids (CEF) concluded that no new study could be identified, which would call for a revision of the current TDI. This TDI is based on the No-Observed-Adverse-Effect-Level (NOAEL) of 5 mg/kg b.w./day from a multi-generation reproductive toxicity study in rats, and the application of an uncertainty factor of 100. This factor is regarded as conservative based on all information on BPA toxicokinetics. The Panel noted that some studies conducted on developing animals have suggested other BPA-related effects of possible toxicological relevance, in particular biochemical changes in brain, immune-modulatory effects and enhanced susceptibility to breast tumours. These studies had several shortcomings. At present the relevance of these findings for human health cannot be assessed. Should any new relevant data become available in the future, the Panel will reconsider this opinion. A minority opinion is expressed by a Panel member and presented in an Annex to this opinion.

Keywords
Bisphenol A, BPA, CAS No. 00080-05-7, developmental toxicity, neurobehaviour, low dose effects.
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Number of Pages
116