The Panel wishes to thank the members of the Working Group on BPA Toxicology: Claire Beausoleil, Diane Benford, Anne Lise Brantsaeter, Gemma Calamandrei, Daniel Doerge, Paul Fowler, Peter Greaves (until July 2012), Ursula Gundert-Remy, Andrew David Hart, Edel Holene, Trine Husøy, Wim Mennes, Ralph Pirow, Iona Pratt (deceased in February 2014), Josef Rudolf Schlatter, Wout Slob, Maria de Fàtima Tavares Poças, Henk Van Loveren, Natalie Von Goetz, Rudolf Antonius Woutersen and Detlef Wölfle for the preparatory work on this scientific opinion and the hearing experts: Jan Alexander, Pasquale Mosesso and Alfonso Siani, and EFSA staff: Anna F. Castoldi, Cristina Croera, Anne Theobald, Davide Arcella, José Cortinas Abrahantes and Johanna Kleine for the support provided to this scientific opinion.
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 and low health concern 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.