Toxicokinetics of Bisphenol A - Scientific Opinion of the Panel on Food additives, Flavourings, Processing aids and Materials in Contact with Food (AFC)


Food additives, flavourings, processing aids and materials in contact with food (AFC)
Panel Members
Fernando Aguilar, Herman Autrup, Sue Barlow, Laurence Castle, Riccardo Crebelli, Wolfgang Dekant, Karl-Heinz Engel, Natalie Gontard, David Gott, Sandro Grilli, Rainer Gürtler, John Chr. Larsen, Catherine Leclercq, Jean-Charles Leblanc, F. Xavier Malcata, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Ivonne Rietjens, Paul Tobback, Fidel Toldrá.

The European Food Safety Authority wishes to thank Jean-Lou Dorne and Detlef Woelfle for
their assistance in the preparation of this opinion.

Opinion of the Scientific Committee/Scientific Panel
Question Number
9 July 2008
23 July 2008
European Food Safety Authority (EFSA), Parma, Italy
Article (61.48 KB)61.48 KB

The Panel has been asked to reconsider the possible age-dependent toxicokinetics of BPA in animals and humans and their implication for hazard and risk assessment of BPA in food. The Panel concluded that the exposure of a human fetus to free BPA would be negligible due to the maternal capacity for conjugation whereas the fetal rat would be exposed to free BPA from the maternal circulation. Taking account of data in human neonates on compounds structurally related to BPA which undergo glucuronidation/sulphation, the Panel considers that there is sufficient capacity in the neonate

 to conjugate BPA at doses below 1 mg/kg bw (the Panel noted that exposures at the TDI of 0.05 mg/kg bw are 20 fold lower than this).
Therefore, the Panel concluded that there is sufficient capacity for biotransformation of BPA to hormonally inactive conjugates in neonatal humans at exposures to BPA that were considered in the EFSA opinion of 2006 and the European Union Risk Assessment Report (EC, 2003, 2008).

In addition, the Panel notes that because of the metabolic differences described, exposure to free BPA in adult, fetal and neonatal rats will be greater than in humans and that rats would therefore be more susceptible to BPA-induced toxic effects than humans on a equivalent dose basis.

The Panel therefore considers that its previous risk assessment based on the overall NOAEL for effects in rats and using a default uncertainty factor of 100 can be considered as conservative for humans. The Panel concluded that the differences in age-dependent toxicokinetics of BPA in animals and humans would have no implication for the EFSA 2006 risk assessment of BPA.

Bisphenol A, BPA, 2,2-bis(4-hydroxyphenyl)propane, 4,4’-isopropylidendiphenol, CAS no. 80-05-7, toxicokinetics, neonate, glucuronidation