EFSA did revise 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 (scientific opinion can be found here).
However, the highest estimates for dietary exposure and for exposure from various sources are three to five times lower than the new tolerable daily intake (TDI).
EFSA will reconsider this temporary TDI when the results of long-term research by the US National Toxicology Program are available in two to three years.
Member Countries respond
FoodQualityNews gives you a taste of the reaction, including a call to withdraw the ban on BPA in France and a comparison of the EFSA group doing the assessment to a little boy with his finger in a leaking dam.
ANSES, the French Agency for Food, Environmental and Occupational Health and Safety, met with EFSA officials in December – see the minutes from this meeting here.
The French Senate banned the use of BPA in all food and drink packaging since the start of the year.
ANSES said there were certain differences between it and EFSA in how uncertainties were accounted for and in the interpretation of available studies.
One difference was that while both considered BPA effects on the mammary gland critical, ANSES drew conclusions from this while EFSA said it could not.
The Swedish Food Federation (Livsmedelsföretagen), which has 800 member companies in the food industry, welcomed the decision.
The group said it hoped it is taken into account when forming the regulation in Sweden. An independent consultation that was published last week made two recommendations as the country investigates the issue.
One was to ban BPA in receipts immediately and the other was to phase it out by 2020 in food contact materials but no legislation was proposed either way.
Sweden banned BPA in varnishes and coatings used in food packaging intended for children under the age of three in 2013.
The polycarbonate/Bisphenol A group of PlasticsEurope called for the French restriction to be withdrawn and called it ‘disproportionate’.
“The fact that any realistic exposure to BPA is well below even the conservative safety threshold established by EFSA shows that blanket restrictions being applied at national level, in particular in France, are unjustified and should be withdrawn,” said Jasmin Bird of the PC/BPA-group.
“This EFSA conclusion on BPA should be used as the basis for consistent and harmonised European food safety regulation, and should be respected by all EU Member States.”
Steven G. Hentges, of the American Chemistry Council (ACC)’s Polycarbonate/BPA Global Group said EFSA’s conclusion is similar to that of the US Food and Drug Administration (FDA).
“The safe exposure limit for BPA, known as a Tolerable Daily Intake, was conservatively set to include uncertainties about potential health effects of BPA," he said.
“Notably, to address a controversial claim that BPA can cause health effects at very low doses, EFSA’s experts established scientific criteria to evaluate studies that reported unexpected responses at low doses.
“Based on these criteria, the experts concluded that “the available data do not provide evidence that BPA results in non-monotonic dose-response relationships.”
Dr John Rost, chair of The North American Metal Packaging Alliance (NAMPA), said it provides still more substantiation that current uses of BPA in food packaging are safe.
“Given that Europe is the birthplace of the Precautionary Principle, this announcement takes on even more prominence, as Europe’s leading food safety body reassures consumers that BPA exposure from foods is not a health concern.”
The British Plastics Federation (BPF) said the panel used a weight-of-evidence approach to all relevant studies on BPA, and a more refined methodology to set the tolerable daily intake (TDI).
Sarah Plant, public and industrial affairs manager at the BPF, said: “The Bisphenol A issue has become highly politicised in recent years and in some countries has become divorced from the reality and nature of its use. The EFSA’s ruling on the safety of BPA provides a solid endorsement which should set consumers’ minds at ease.”
The Food and Drink Federation (FDF) welcomed the opinion and said it should be the basis for regulatory decisions.
It urged the European Commission and Member States to ensure national measures are based on science.
However, Breast Cancer UK urged consumers to “exercise caution” and continue to avoid unnecessary exposure to the hormone disrupting chemical BPA.
Lynn Ladbrook, chief executive of Breast Cancer UK, said the decision was a ‘missed opportunity for breast cancer prevention’.
“There are now many studies that suggest that BPA can have effects at very low levels and this was EFSA’s opportunity to call for tougher safety measures that prohibit the use of BPA in food and drinks packaging," she said.
“Instead , EFSA’s announcement could lull the public into a misguided sense of security when it comes to exposures to the hormone disrupting chemicals like BPA.”
It is important to note EFSA accepts there are “uncertainties” surrounding potential health effects on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems, it added.
Chem Trust said it is unclear why the abstract states there is “no health concern” from real world exposure, yet the summary said “health concern is low” which does not seem to be the same thing at all.
Gwynne Lyons, policy director at Chem Trust said it was at least glad to see the TDI has been reduced but added it likely that this will again need to be reduced in future.
“We still deplore the fact that the reported low dose effects on the mammary gland have not played a greater role in the risk assessment, as it certainly seems more likely to us that the mammary gland rather than the kidney would be the most important target of an estrogenic substance, like BPA.
“This EFSA group doing the assessment of the toxicity of BPA are like the little boy with his finger in the leaking dam, in that they will likely soon be swept away in a flood of new studies.
“Nevertheless, even now, with such remaining uncertainties relating to both the effects and internal exposure, it is difficult to conclude that BPA is unambiguously safe.”