No consumer health risk from bisphenol A exposure.
EFSA’s comprehensive re-evaluation of bisphenol A (BPA) exposure and toxicity concludes that BPA poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels. Exposure from the diet or from a combination of sources (diet, dust, cosmetics and thermal paper) is considerably under the safe level (the “tolerable daily intake” or TDI).
Although new data and refined methodologies have led EFSA’s experts to considerably reduce the safe level of BPA from 50 micrograms per kilogram of body weight per day (µg/kg of bw/day) to 4 µg/kg of bw/day, the highest estimates for dietary exposure and for exposure from a combination of sources (called “aggregated exposure” in EFSA’s opinion) are three to five times lower than the new TDI.
Uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems have been quantified and factored in to the calculation of the TDI. In addition, the TDI is temporary pending the outcome of a long-term study in rats, which will help to reduce these uncertainties.
EFSA´s scientific opinion consists of 3 parts. These are available here.
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Refined assessment of BPA toxicity
After weighing up a significant body of new scientific information on its toxic effects, the CEF Panel concluded that high doses of BPA (hundreds of times above the TDI) are likely to adversely affect the kidney and liver. It may also cause effects on the mammary gland in animals.
Studies indicating BPA as the cause of other health effects were less conclusive.“Effects on the reproductive, nervous, immune, metabolic and cardiovascular systems, as well as in the development of cancer are not considered likely at present but they could not be excluded on the available evidence. So, they add to the overall uncertainty about BPA-related hazards and therefore have been considered in the assessment.
The Panel also assessed the possibility that BPA results in unexpected responses to different doses, e.g. adverse effects that are only induced by low BPA doses (known as ‘non-monotonic dose-response’ or NMDR relationships). The experts concluded that the available data do not provide evidence of such relationships for the health effects considered.
Exposure: dietary picture clearer, non-dietary less certain
In 2006, when EFSA last assessed dietary exposure to BPA, fewer data were available and EFSA’s experts were required to make several conservative assumptions about consumption and the levels of BPA in food. “With significantly more and better data we have updated and more accurately estimated dietary exposure to BPA for all population groups, said Dr Husøy. “As a result, we now know that dietary exposure is four to fifteen times lower than previously estimated by EFSA, depending on the age group.”
For the first time, EFSA has also considered exposure to BPA from non-dietary sources. There is a lack of supporting data on dermal exposure – for example, how much BPA the body absorbs through skin by touching thermal paper – which really increases the uncertainty of estimates from thermal paper and cosmetics.
Quantifying and factoring in uncertainties
EFSA’s experts used new methodologies to take account of the uncertainties regarding potential health effects, exposure estimates and evaluation of risks for humans. By analysing each uncertainty one by one and combining expert judgement the Panel was able to quantify these uncertainties and to factor them in to its risk assessment and derivation of the TDI.
EFSA will reconsider the temporary TDI when the results of long-term research by the US National Toxicology Program are available for evaluation in two to three years. This research is expected to address many of the remaining uncertainties about BPA’s toxic effects.
