Feb 9 2007
The European Food Safety Authority (EFSA) has today announced its opinion on dietary exposure to the chemical bisphenol A (BPA). People are exposed to BPA in food through its use in certain plastic and other materials that are used in products such as bottles and cans. EFSA’s scientific AFC Panel[1], has concluded that the setting of a full rather than a temporary Tolerable Daily Intake (TDI) is now appropriate, following an extensive review, including all available new data from the last five years. People’s dietary exposure to BPA, including that of infants and children, is estimated to be well below the new TDI.
The re-evaluation of BPA focused on effects on reproduction and the endocrine (hormonal) system, about which there has been much scientific debate. Having considered both the pre-2002 and new studies available, the Panel concluded that the no-observed-adverse-effect level (NOAEL) of 5 milligram/kg body weight/day identified in the previous evaluation in 2002, remains valid. The Panel also concluded that reports of low-dose endocrine effects of BPA in rodents did not demonstrate such activity in ways that were robust or reproducible.
New studies have shown significant differences between humans and rodents, such as the fact that people metabolise and excrete BPA from their system far more quickly than rodents, further limiting the relevance of low-dose effects of BPA reported in some rodent studies for human risk assessment. Studies have also shown that mice are particularly sensitive to oestrogens. Given that BPA is a weak oestrogen, the absence of adverse effects at 5 milligram/kg body weight and below in a new robust study on mice and two generations of their offspring adds further confidence to the risk assessment.
The AFC considered the strength of the scientific evidence now available and the remaining uncertainties and included an uncertainty factor of 100 into its calculations to reach the TDI, which is common scientific practice. On this basis the Panel established a full TDI of 0.05 milligram/kg body weight. The previous temporary TDI, set in 2002, included an uncertainty factor of 500, but this has been reduced due to the substantial scientific evidence now available.