EFSA poised to slash daily exposure limits for bisphenol A as EU court confirms it as ‘substance of very high concern’

22-Dec-2021 - Last updated on 22-Dec-2021 at 10:55 GMT

Image: Getty/Sally Anscombe

The European Food Safety Authority (EFSA) is to re-evaluate the risks of bisphenol A (BPA) in food as the Court of Justice of the EU confirms the chemical must be listed as a “substance of very high concern” for its hormone-disrupting properties on the human body.

EFSA is proposing to “considerably lower” the tolerable daily intake (TDI) of BPA -- a chemical used to make plastics -- compared to its previous assessment in 2015. EFSA’s conclusions on BPA are explained in a draft scientific opinion that is open for public consultation until 8 February 2022. All interested parties are encouraged to contribute to the consultation.

In its 2015 risk assessment of BPA, EFSA set a temporary TDI of 4 micrograms per kilogram of body weight per day. In its draft re-evaluation of BPA, EFSA’s expert Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) has now established a TDI of 0.04 nanograms per kilogram of body weight per day, dramatically cutting the daily exposure limits by a factor of 100,000.

According to the EFSA, the lowering of the TDI is a result of the assessment of studies that have emerged in the literature since 2013 until 2018, particularly those which indicate adverse effects of BPA on the immune system.

For example, in animal studies, an increase was observed in the number of “T-helper” cells, a type of white blood cell which play a key role in cellular immune mechanisms and which when raised can lead to the development of allergic lung inflammation.

By comparing the new TDI with estimates of consumer exposure to BPA in the diet, EFSA concludes that those with both average and high exposure to BPA in all age groups exceed the new TDI, indicating health concerns.

A systematic approach

Dr Claude Lambré, Chair of the CEP Panel of experts, said: “This updated draft is the result of a thorough assessment over several years. We have used a systematic approach for selecting and appraising the available evidence. The new scientific studies that have emerged in literature have helped us address important uncertainties about BPA’s toxicity.”

BPA is a chemical that is used to manufacture polycarbonate plastic, which may be used to make certain food contact materials such as water dispensers or articles for food production. BPA is also used to produce epoxy resins to form protective coatings and linings for food and beverage cans. Small amounts of BPA can migrate from food contact materials into foods and beverages.

BPA is already banned in the EU for some products – such as baby bottles. France has banned BPA in all food packaging, containers and utensils.

EFSA previously assessed the safety of BPA for use in food contact materials in 2006 and 2015. At the time of EFSA’s latest assessment, experts were only able to set a temporary TDI due to uncertainties and highlighted the need to fill data gaps.

Court ruling upholds BPA concerns

Yesterday (Dec 21), the Court of Justice of the EU also rejected attempts by PlasticsEurope to reverse the decision of the European Chemicals Agency (ECHA) to identify BPA as hazardous for the endocrine system – and therefore of very high concern.

The court confirmed that BPA – must be listed as a “substance of very high concern” for its hormone-disrupting properties on the human body.

Following scientific work done by the French authorities, the ECHA identified BPA as hazardous for the endocrine system.
With the ruling, the Court rejected the final attempt by lobby group PlasticsEurope to reverse ECHA’s decision – so BPA will stay on the official list of substances of very high concern. PlasticsEurope cannot appeal this judgment.

Alice Bernard, in-house lawyer at environmental law charity ClientEarth, intervener in the case, said: “BPA is one of the most studied chemicals and its hormone-disrupting properties for humans are well-documented. The Court confirmed that ECHA’s decision to flag BPA as a ‘substance of very high concern’ was legal and grounded in science. ECHA and the French authorities should be praised – this is not only a victory for public health, but also shows that public authorities can and should resist to industry pressures.

“We know there are still many hormone-disrupting chemicals not yet recognised as such under EU law. It’s up to the EU Commission and national public authorities to initiate actions to fill the gaps. This judgment undoubtedly strengthens their hand and needs to be a catalyst for further action. The industry needs to invest in alternatives rather than spend resources in fighting much-needed regulation in court.”

This judgement was also applauded by the Center for International Environmental Law (CIEL), which called it “an important step towards recognizing that plastics are a global health crisis hiding in plain sight”.

Sian Sutherland Co-Founder of A Plastic Planet, another campaigner, said in a tweet: “This is a huge step towards plastic manufacturers and users realising their material is harmful to human health. And now to ensure big plastic doesn’t just switch to the bisphenol alternatives that are BPA by another name.”