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News

EFSA proposes slashing exposure limits for BPA

03/05/2023 - Press release , François-Xavier Branthôme

The European Food Safety Authority (EFSA) has proposed a tolerable daily intake for the widely used substance bisphenol-A which is 20,000 times lower than the current threshold, drawing criticism from industry and some regulators.

Dietary exposure to bisphenol A (BPA) is a health concern for consumers across all age groups, EFSA’s scientific experts have concluded in a new re-evaluation. In an extensive assessment of the scientific evidence, and after input from a public consultation, EFSA’s experts identified potentially harmful health effects on the immune system.
The European Commission and national authorities will discuss appropriate regulatory measures to follow up on EFSA’s advice.

BPA is a chemical substance used in combination with other chemicals to manufacture certain plastics and resins. BPA is used for example in polycarbonate plastic, a transparent and rigid type of plastic used to make water dispensers, food storage containers and reusable beverage bottles. The substance is also used to produce epoxy resins found in protective coatings and linings for food and beverage cans and vats.

Chemicals such as BPA used in foodstuff containers can migrate in very small amounts to the food and drinks they contain, so EFSA’s scientists regularly review their safety, considering new data.

Vast dataset
Dr. Claude Lambre, Chair of EFSA’s Panel on Food Contact Materials, Enzymes and Processing Aids, said: “Our scientists have examined the safety of BPA in great detail over the years since our first full risk assessment of the substance in 2006.
“For this re-evaluation, we scrutinized a vast quantity of scientific publications, including over 800 new studies published since January 2013. This has allowed us to address important uncertainties about BPA’s toxicity.
“In the studies, we observed an increase in the percentage of a type of white blood cell, called T helper, in the spleen. They play a key role in our cellular immune mechanisms and an increase of this kind could lead to the development of allergic lung inflammation and autoimmune disorders,” he said.
The Panel also took into account other potentially harmful health effects on the reproductive, developmental and metabolic systems that were identified in the risk assessment.

Systematic approach
Dr. Henk Van Loveren, Chair of EFSA’s working group for the re-evaluation of BPA, said: “To assess the large number of studies published since 2013 - the cut-off point for our previous assessment in 2015 - we applied a systematic and transparent approach. We developed upfront a protocol for selecting and appraising all the evidence with the input of stakeholders and Member State competent authorities.
“Our findings are the result of an intense evaluation process that has lasted several years and which we finalized using the input we gathered from a two-month public consultation launched in December 2021,” he added.

Lower intake threshold
Compared to their previous assessment in 2015, EFSA’s expert Panel significantly lowered the tolerable daily intake (TDI) for BPA, the amount that can be ingested daily over a lifetime without presenting an appreciable health risk.
In 2015, experts set a temporary TDI due to uncertainties in the evidence, highlighting the need for additional data on the toxicological effects of BPA.
This new re-evaluation addressed most of these gaps and remaining uncertainties were taken into account when setting the TDI.

EFSA’s scientists established a TDI of 0.2 nanograms (0.2 billionths of a gram) per kilogram of body weight per day, replacing the previous temporary level of 4 micrograms (4 millionths of a gram) per kilogram of body weight per day.
The newly established TDI is around 20,000 times lower.

Exposure to BPA
By comparing the new TDI with estimates of dietary exposure to BPA, EFSA experts concluded that consumers with both average and high exposure to BPA in all age groups exceeded the new TDI, indicating health concerns.
Although the expert Panel used the exposure estimates from their assessment in 2015, EFSA acknowledges that restrictions brought in by EU legislators after 2015 on some uses of the substance may have reduced dietary intake. This means that the scenario is conservative.
Several variables can influence the overall health risk for an individual, including other stressors on the human body, genetics and nutrition.

Criticism of EFSA's methodology
As well as consulting on the draft scientific assessment, EFSA consulted publicly in 2017 on the protocol describing the proposed methodology.
The scientists also discussed the methodology and findings with other scientific bodies to clarify and/or resolve differences that emerged such as the use of ‘intermediate endpoints’, which are early signals that indicate the potential development of adverse health effects.

The results of EFSA's re-evaluation is a blow Europe's plastics industry, who attempted to reverse the ECHAs 2021 decision identifying BPA as a substance of concern. The attempts were rejected by the Court of Justice, who confirmed that BPA should be listed a “substance of very high concern”.
But it is the approach used by EFSA to derive its new TDI for BPA that the plastics sector takes issue with. The stance follows Germany's Federal institute for Risk Assessment (BfR) opinion, issued on the same day, criticizing EFSAs assessment.
"The BfR does not support the new TDI derived by EFSA due to several scientific and methodologic divergences. For example, there is currently no evidence that the observed relative increases in the levels of Th17 cells trigger any adverse effects on the mice studied, and the relevance on the results to human health is questionable," noted BfR.

The European Medicines Agency (EMA) has also presented its different views on the methodology of the EFSA re-evaluation.
Based on BfR's analysis of the scientific data on toxicological effects from gastrointestinal exposure to BPA, the BfR has derived a TDI value of 0.2 micrograms (200 nanograms) per kg of body weight per day. This value is 20 times lower than EFSA's previous provisional TDI, and 1,000 times higher than EFSA's new TDI.
Trade association Plastics Europe's polycarbonate/bisphenol A group said it was “highly concerned” to see a “controversial approach” used to derive the new TDI for BPA.
"This approach has been strongly criticized by several competent authorities, as well as by industry. These diverging views have not been sufficiently built into the final EFSA conclusion.
"The final opinion is suffering from serious scientific weaknesses and results in an over-conservative TDI," noted the group. "Therefore, it cannot be used as such for risk management measures. Any risk management measures based on this conservative TDI also beyond food contact, must take into account all its weaknesses."

In this context, EFSA have published joint reports summarizing discussions with the European Medicines Agency (EMA) and the German Federal Institute for Risk Assessment (BfR).
Discussions such as these with our partners and stakeholders help the further development of risk assessment methodologies that are used for our safety assessments, taking into account the latest scientific knowledge and understanding of potential risks.

Next steps
EU decision-makers, namely the European Commission and Member State representatives, are responsible for setting limits on the amount of a chemical that may migrate from food packaging into food.

EFSA’s scientific advice on BPA will now inform discussions among EU lawmakers on the appropriate regulatory measures to take to protect consumers.

Some complementary data
To access joint reports, click here.

Sources: efsa.europa.eu, endseurope.com, foodnavigator.com

Bisphenol A: EFSA draft opinion proposes lowering the tolerable daily intake

02/02/2022 See details

FDA: BPA is safe

28/02/2018 See details

Stricter BPA regulation to apply from September

27/02/2018 See details

EU expresses \"high concern\" for bisphenol A

18/09/2017 See details

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