EFSA's scientific experts have provisionally concluded that for all population groups diet is the major source of exposure to bisphenol A (BPA) and exposure is lower than previously estimated by EFSA. BPA is a chemical compound used in food contact materials such as packaging as well as in other consumer products. This is the Authority's first review of exposure to BPA since 2006 and the first to cover both dietary and non-dietary sources (including thermal paper and environmental sources such as air and dust). As part of a two-stage process of its full risk assessment, EFSA is now seeking feedback on this draft assessment of consumer exposure to BPA. During a later phase, EFSA will publicly consult on the second part of its draft opinion, focussing on its assessment of the potential human health risks of BPA.
New data resulting from an EFSA call for data led to a considerable refinement of exposure estimates compared to 2006. For infants and toddlers (aged 6 months-3 years) average exposure from the diet is estimated to amount to 375 nanograms per kilogram of body weight per day (ng/kg bw/day) whereas for the population above 18 years of age (including women of child-bearing age) the figure is up to 132 ng/kg bw/day. By comparison, these estimates are less than 1% of the current Tolerable Daily Intake (TDI) for BPA (0.05 milligrams/kg bw/day) established by EFSA in 2006.
For all population groups above three years of age thermal paper was the second most important source of BPA after the diet (potentially accounting for up to 15% of total exposure in some population groups).
Among other key findings, scientists found dietary exposure to BPA to be the highest among children aged three to ten (explainable by their higher food consumption on a body weight basis). Canned food and non-canned meat and meat products were identified as major contributors to dietary BPA exposure for all age groups.
To derive these exposure estimates, experts on EFSA's Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) applied two approaches: exposure modelling and analysis of human biomonitoring data (from urine samples).
Exposure modelling involves the assessment of exposure to BPA through food and non-food sources (thermal paper, air, dust, toys, cosmetics, dental sealants) and routes (diet, inhalation and skin contact) in the EU population. This method allows for the estimation of exposure from all sources which could be identified and quantified individually.
Urinary biomonitoring data (that is, levels of BPA found in the urine) were used to corroborate the Panel's estimates of overall BPA exposure and to ensure no major source of exposure was missed.
The Panel's draft opinion includes analysis of possible uncertainties in the exposure assessment. The estimates of dietary exposure based on the data on occurrence of BPA in food and EFSA's Comprehensive European Food Consumption Database are considered robust. However, there are uncertainties regarding exposure from thermal paper and more data are needed especially related to BPA skin absorption and cash receipt handling habits in order to provide a refined estimate of exposure through this source.
Public consultation and ongoing work
All stakeholders and interested parties will be able to provide their comments on the draft exposure assessment from 25 July to 15 September 2013. EFSA decided on a two-stage public consultation in the interests of transparency and in line with the Authority's willingness to consult with all stakeholders before conclusion of its full risk assessment.
BPA is used in the manufacture of polycarbonate (PC) plastics, epoxy resins and other polymeric materials, and also for certain paper products (e.g. thermal paper). PC is used for food and liquid containers such as tableware (plates and mugs), microwave ovenware, cookware, reservoirs for water dispensers and non-food applications such as toys and pacifiers with PC shields. BPA-based epoxyphenolic resins are used as protective linings for food and beverage cans and as a coating on residential drinking water storage tanks. BPA is also used in a number of non food-related applications, e.g. epoxy-resin based paints, medical devices, surface coatings, printing inks and flame retardants.
EFSA completed its full risk assessment of BPA as a food contact material in 2006 and set a Tolerable Daily Intake (TDI) of 0.05 mg/kg bw/day (or 50,000 ng/kg bw/day) for this substance. The TDI is an estimate of the amount of a substance, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable risk. In its 2006 risk assessment EFSA also evaluated intakes of BPA through food and drink, for adults, infants and children and found that they were all well below the TDI. EFSA has updated its scientific advice on BPA several times since 2006, most recently updating its risk assessment in 2011. However, exposure assessment was not considered in these previous updates.
In February 2012, following further consideration of new scientific studies, the CEF Panel decided to undertake a full re-evaluation of the human risks associated with exposure to BPA through the diet, also taking into consideration the contribution of non-dietary sources to the overall exposure to BPA. For this purpose all the available data and scientific studies on occurrence data of BPA in food and non-food sources published since EFSA's 2006 Opinion have been reviewed. Besides exposure, the Panel is carrying out a full assessment of the potential human health risks of BPA, including further evaluation of the possible relevance for human health of some BPA-related effects observed in test animals at low dose levels.
Comparison of BPA dietary exposure estimates from 2006 and 2013:
- For infants (up to 3 months) dietary exposure is estimated to be some 30 times lower than previously stated (135 ng/kg bw/day in 2013 compared to 4,000 ng/kg bw/day in 2006).
- For adults (including women of child-bearing age) the 2013 estimate is approximately 11 times lower than in 2006 (up to 132 ng/kg bw/day in 2013 compared to 1,500 ng/kg bw/day in 2006).
Table 23 (page 68 of the current draft opinion) provides an overview of exposure to BPA from all sources. Table 33 (page 107) includes the estimates for 2006 and 2013 as well as BPA estimates from other exposure assessments (including those by the French food safety agency - Anses and by FAO/WHO).