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

The European Food Safety Authority (EFSA) has re-evaluated the risks of bisphenol A (BPA) in food and proposes to considerably lower the tolerable daily intake (TDI) 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.

The TDI is an estimate of the amount of a substance (expressed on a kilogram body weight basis) that can be ingested daily over a lifetime without appreciable risk. 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, published today, EFSA’s expert Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) has established a TDI of 0.04 nanograms per kilogram of body weight per day. The lowering of the TDI results from 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. In animal studies, an increase was observed in the number of «T-helper» cells, a type of white blood cells 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.»

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.

EFSA’s experts conducted extensive preparatory work for this new evaluation, including the publication and testing of the hazard assessment protocol in 2017 and in 2019.

Have your say!

EFSA invites all interested parties to submit feedback on its draft opinion via the dedicated consultation page. The deadline for comments is 8 February 2022.

EFSA - European Food Safety Authority