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Bisphenol A – new EFSA assessment cuts safe exposure level, calls for more research (updated)

The European Food Safety Authority (EFSA) have today published the opinion of their CEF scientific panel [1] on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs.

[See end of this blog item for a challenge to the EFSA assessment from the National Food Institute at the Technical University of Denmark]

In this opinion they have cut their estimate of the safe exposure level (temporary Tolerable Daily Intake (t-TDI)) to 4 micro g/kg body weight per day, down from the 5 micro g/kg body weight per day that was calculated in the draft opinion at the start of 2014.

This is more than 10x lower than the 50 micro g/kg body weight per day TDI established by EFSA in 2006/7, showing how new research on BPA is leading to reductions in the dose thought to be toxic.

The EFSA opinion also includes an examination of exposure to BPA though food and through non-dietary sources, such as dust and till receipts (i.e. an estimate of real world exposure), and “the CEF Panel noted that there is a considerable uncertainty in the exposure estimate for the non- dietary sources“. They also conclude that “ health concern for BPA is low at the estimated levels of exposure” when real world exposures are added, in contrast to claiming ‘no health concern’ when looking only at exposures from food. It’s worth noting that this exposure assessment doesn’t include exposure from medical devices. [Updatethe relevant EU scientific committee for medical devices has now recommended “that, where practicable, medical devices that do not leach BPA should be used“].

There is a surprising difference between how the abstract and the summary of this executive summary document describe the conclusions of the study:

Abstract (our highlighting):

“By comparing this t-TDI with the exposure estimates, the CEF Panel concluded that there is no health concern for any age group from dietary exposure or from aggregated exposure. The CEF Panel noted considerable uncertainty in the exposure estimates for non-dietary sources, whilst the uncertainty around dietary estimates was relatively low.”

Summary (page 22 – our highlighting):

“The CEF Panel concludes that the dietary exposure to BPA for the highest exposed groups, which includes infants, children and adolescents, is below the t-TDI of 4 micro g/kg bw per day, indicating that there is no health concern for BPA at the estimated levels of exposure. These conclusions also apply to prenatally exposed children and to the elderly.

In addition, the CEF Panel concludes that the central estimates for aggregated exposure to BPA via the dietary and non-dietary sources (dust, toys, cosmetics and thermal paper) for the highest exposed groups, which includes infants, children and adolescents, is also below the t-TDI of 4 micro g/kg bw per day, indicating that the health concern for BPA is low at the estimated levels of exposure. However, the CEF Panel noted that there is a considerable uncertainty in the exposure estimate for the non- dietary sources.”

It is unclear why that abstract states that there is “no health concern” from aggregated (=real world) exposure, yet the summary states that “health concern is low” – which does not seem to be the same thing at all. [Update: Following a letter from CHEM Trust, EFSA corrected the abstract – but not the press release]

The EFSA press release echoes the text in the abstract rather than the summary (our emphasis):

No consumer health risk from bisphenol A exposure, Press Release,21 January 2015

EFSA’s comprehensive re-evaluation of bisphenol A (BPA) exposure and toxicity concludes that BPA poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels. Exposure from the diet or from a combination of sources (diet, dust, cosmetics and thermal paper) is considerably under the safe level (the “tolerable daily intake” or TDI)….”

This raises questions as to whether EFSA is trying to spin the results of this assessment, rather than reflecting the reality of what the panel found.

The issue of aggregate exposure is particularly interesting given that uncertainty over the non-dietary sources meant that:

Upper bounds for the uncertainty of high but not average aggregate exposure estimates to BPA exceed the t-TDI .. The wide uncertainty intervals are caused by uncertainty about the magnitude of external exposure to BPA from thermal paper, about the proportion of the amount of BPA which is absorbed through the skin, and about the choice of … model for converting dermal exposures to oral equivalents.”

Or to put it another way, because we don’t know enough about non dietary exposure, it is possible that some people could have exposure that exceeds the temporary tolerable daily intake.

Unsurprisingly, the assessment also calls for more research into bisphenol A, including skin absorption; reproductive, neurobehavioural, immunological and metabolic endpoints; and into non-monotonic dose responses to BPA.

Gwynne Lyons, Policy Director at CHEM Trust said:

we are at least glad to see that the Tolerable Daily Intake has been reduced by an order of magnitude since 2006, and CHEM Trust considers it is likely that this will again need to be reduced in future.  As was the case with the neurotoxic substance lead, it often takes time for the full toxicity of any substance to be unravelled.”

the final assessment of the toxicity of BPA is largely  a regurgitation of the earlier draft assessment, but with a bit more transparency in how decisions were derived.  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. CHEM Trust would now like to see that exposures are further reduced, particularly including those of pregnant women, young children and children around puberty.”

CHEM Trust had already submitted comments to a draft of this assessment.

ENDS Europe have covered the BPA opinion and CHEM Trust’s comment, as have Food Quality News and Chemical Watch.

Update, 15th February

ENDS Europe are reporting that the French Government are under increasing pressure (including from the UK Government) over their proposal to ban BPA in till receipts. CHEM Trust are quoted:

But Gwynne Lyons of NGO ChemTrust said there were many uncertainties in EFSA’s risk assessment, meaning France is “totally justified” to continue with its regulation with a view to protecting public health.

Update, 24th February

The National Food Institute at the Technical University of Denmark has challenged the new EFSA limit, arguing that it is too high:

The National Food Institute’s scientists evaluate that EFSA’s new TDI does not adequately protect against endocrine disrupting effects. One reason is that EFSA does not apply an appropriate uncertainty factor. Moreover the researchers find that EFSA in establishing the new TDI has not sufficiently taken data from animal studies showing effects on female mammary gland, the male reproductive system, and brain development and function into account.

According to the National Food Institute’s calculations the new TDI should be 0.7 micrograms per kilogram body weight per day or lower to be sufficiently protective against endocrine disrupting effects

…comparison of the exposure to the TDI recommended by the National Food Institute shows that humans with a high exposure may exceed the safe limit. Their intake can come from food, cash receipts and cosmetics

This is less than a fifth of the EFSA suggested limit. They also point out that this analysis – like almost every analysis of the safety of chemicals – ignores some key factors:

Neither EFSA’s nor the National Food Institute’s risk assessment takes into account that there can be increased risk caused by bisphenol A if present in a chemical cocktail with other environmental chemicals that have similar effects to bisphenol A. This means that the risk in both cases may be underestimated.

Update, March 5th

[1]  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)