EFSA identifies ‘key limitations’ in BPA studies and stands by TDI

By Joseph James Whitworth contact

- Last updated on GMT

Evidence is too limited that BPA affects human immune system – EFSA

Related tags: Immune system, European union

The European Food Safety Authority (EFSA) has said limitations in the design and conduct of two studies on BPA means they cannot be used to draw any conclusions for human health.

The agency said the data was too variable for setting a new tolerable daily intake (TDI) for bisphenol A (BPA).

A report from the Dutch National Institute for Public Health and the Environment (RIVM​) cited two studies by Ménard et al and recommended EFSA re-evaluate safety thresholds.

Limitations in studies design and conduct

The studies were unpublished when EFSA last evaluated BPA in 2015.

They suggested food intolerance and reduced resistance (impaired immune response) to parasitic infection in rats exposed to 5 µg of BPA per kg bw/day. The doses were administered perinatally (i.e. before and just after birth).

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) said factors such as use of a single dose for the majority of the tests prevents meaningful assessment of their relevance for human health.

It added that for the only effect tested at three BPA doses, when plotted on a graph, the data results are so scattered and variable that they do not allow identification of a reference point for the immunotoxicity of BPA and cannot be used to set a TDI.

Dr Fleur van Broekhuizen, lead author of the RIVM report, said: “RIVM welcomes EFSA's confirmation of our assessment that BPA might affect the immune system. We look forward to the outcome of EFSA’s next review of scientific evidence on BPA.” 

EFSA said the work confirms a previous conclusion that BPA might affect the immune system in animals.

PlasticsEurope welcomes decision

PlasticsEurope said the EFSA opinion of 2015 took remaining uncertainties into account by introducing an additional uncertainty factor when deriving the current TDI.

“Given the clear results of today’s opinion by EFSA, the European Union can now move forward swiftly with the new draft regulation on BPA based on the EFSA opinion of 2015 – there should be no further delay,”​ said Jasmin Bird of the Polycarbonate/Bisphenol A Group.

The trade association, with members including BASF, Borealis, Evonik, Braskem, Covestro, Solvay and SABIC Europe, said calls by the European Parliament for a ban of BPA in food contact materials​ are ‘clearly disproportionate’ and ‘unjustified’ given the EFSA opinion.

The vote was part of an amendment from the Greens group to a draft implementation report on regulation of FCMs.

The BPA Coalition said the amendment shows members of the European Parliament have decided they know more about the impact of FCMs on human health than EFSA.

“[The] ban on BPA in food contacts called for by MEPs in October is misleading, as it discredits the work of Europe’s expert toxicologists and scientists, creates and exacerbates problems of trust in public agencies such as EFSA, and undermines other important legislative efforts.”

EFSA will review its temporary TDI of 4 micrograms per kilogram of body weight (µg/kg bw/day) after evaluating scientific evidence on BPA toxicity published since 2012.

This will start next year and EFSA promised to consult on how to search, review and integrate scientific evidence not included in the previous assessment before the re-evaluation begins.

The TDI was reduced from 50 to 4 µg/kg bw/day on a temporary basis pending results from the US National Toxicology Program expected in 2017.

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