EFSA draft opinion on the risks from BPA
The European Food Safety Authority (EFSA) in 2013 launched a two-stage public consultation on its draft opinion on the possible risks to public health from bisphenol A (BPA).
The first stage of the consultation looked at EFSA’s updated and comprehensive assessment of consumer exposure to BPA in Europe. EFSA’s scientific experts provisionally concluded that for all population groups diet is the major source of exposure to BPA and exposure is lower than previously estimated by EFSA.
The second stage of the consultation, which ended on 13 March 2014, looked at its assessment of the potential human health risks of BPA and recommendation that the current tolerable daily intake (TDI) be lowered.
Once EFSA publishes its opinion on BPA – following consideration of comments received from these consultations – the Food Standards Agency will consider, along with the European Commission and EU member states, whether action is necessary to protect consumers.
What are the Food Standard Agency’s conclusions on the European Food Safety Authority’s (EFSA) draft opinion the risks from BPA?
The FSA supports the approach taken by EFSA and its conclusion that on the balance of evidence, at current levels of exposure there is no appreciable health risk.
The FSA will consider its advice and position on BPA in light of the final EFSA Opinion. It will work with other EU member states and the European Commission to consider if any further risk management measures are required and to ensure a harmonised and proportionate risk based approach to managing the issue across the European Union.
The National Toxicology Programme (NTP) is conducting a long-term study in rats involving prenatal as well as postnatal exposure to BPA. This study will clarify whether the changes in the mammary gland seen in some studies will result in an increased incidence of tumours in humans.
The assessment is expected within the next 4 years.
If BPA is banned in polycarbonate infant feeding bottles why can’t we do the same for BPA in other food contact materials?
EFSA’s comprehensive review gives us a sound evidence base for decision-making, and does not suggest a need to ban BPA in other food contact materials.
Does reducing the Tolerable Daily Intake (TDI) temporarily to 5 ug/kg body weight a day, (down from the current 50 ug/kg) suggest that there is an issue with BPA?
This is an example of adjustment in light of new scientific evidence. But the estimated exposure is still lower than the reduced TDI.
Does the EFSA opinion take account of the non-monotonic dose/ low dose effect of BPA? Some recent scientific studies show evidence of potential adverse effects of BPA at low levels.
EFSA considered the phenomenon of non-monotonic dose response (NMDR) and concluded that there was insufficient evidence for it occurring. The reports in relation to observations at low doses have been assessed and taken into account by EFSA in its weight of evidence approach.
EFSA has said there are still continuing uncertainties over the risks posed by BPA. Does this represent a health risk to humans?
No, EFSA has considered this in its draft opinion and has set the TDI taking account of those uncertainties. It proposed the Tolerable Daily Intake (TDI) should be set on a temporary basis pending the outcome of research from the US National Toxicology Program (NTP) which will address the main uncertainties about the potential health effects of BPA.
Given that the main source of uncertainty is the observations of proliferation or altered differentiation in the mammary gland; should this not be grounds for concern for women?
No, EFSA has set the temporary TDI (t-TDI) at a level which takes into account these effects.
If there are still uncertainties as reported in the EFSA opinion, should the FSA not ban BPA on precautionary grounds
No because the TDI has been set taking account of the uncertainties