Bisphenol A immune system safety to be reviewed

EFSA is setting up a working group of international experts to evaluate new scientific evidence on the potential effects of bisphenol A (BPA) on the immune system. EFSA is conducting the review following publication of a report that raises concerns about the effects of BPA on the immune system of fetuses and young children.

The report by the Dutch National Institute for Public Health and the Environment (RIVM), critically examines two studies describing pre- and perinatal effects of BPA on the immune system by Menard et al. (2014) that were unpublished when EFSA reviewed the available scientific literature for its 2014 risk assessment of BPA.

The report recommends supporting research on alternatives to BPA and advising consumers to reduce their exposure to BPA from food and other sources.

EFSA accepted a request from the Dutch Ministry of Health to examine the results of the RIVM report and specifically will review the toxicity of BPA on the immune system in light of this new evidence. EFSA’s expert Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) aims to issue a statement in the next few months.

Temporary safe level

In December 2014, EFSA’s CEF Panel reduced the tolerable daily intake (TDI) for BPA from 50 micrograms per kilogram of body weight per day (µg/kg bw/day) to 4 µg/kg bw/day.

The TDI was made temporary to account for uncertainty about the possible effects of BPA on the mammary gland, reproductive, neurological, immune and metabolic systems in laboratory animals.

The overall weight of scientific evidence did not allow EFSA’s experts to conclude whether or not these effects would occur in animals and humans and be harmful. To account for the gaps in current knowledge about these possible effects, an additional uncertainty factor was applied.

EFSA to re-evaluate BPA in 2017-2018

By setting a temporary TDI, EFSA committed to the re-evaluation of BPA when a two-year study by the U.S. National Toxicology Program becomes available in 2017.

In addition to its review of the RIVM report, EFSA has begun to prepare for this upcoming evaluation of the hazards of BPA by developing a “scientific protocol” for a structured literature search and a transparent review of all the new scientific evidence not included in EFSA’s previous assessment. Procurement is underway for the collection and extraction of data on BPA toxicology from scientific studies published since 2012.

EFSA will consult publicly on the protocol, which is a predefined written procedural method for the collection, extraction and appraisal of data, by early 2017. Stakeholders from public authorities, academia and civil society will be able to have their say on EFSA’s planned approach before work begins. The final scientific opinion is scheduled for completion in 2018.

Background

The two studies reviewed in the RIVM report are:

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