Bisphenol A immune system safety to be reviewed

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 (2014) that were unpublished when EFSA reviewed the available scientific literature for its 2014 risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. of BPA.

The report recommends supporting research on alternatives to BPA and advising consumers to reduce their exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. 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 The potential of a substance to cause harm to a living organism. 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.

• Mandate on RIVM report on Bisphenol A: evaluation of developmental immunotoxicity results
• RIVM Report: Bisphenol A Part 2. Recommendations for risk management

Temporary safe level

In December 2014, EFSA’s CEF Panel reduced the tolerable daily intake An estimate of the amount of a substance in food or drinking water which is not added deliberately (e.g contaminants) and which can be consumed over a lifetime without presenting an appreciable risk to health.  ( TDI The tolerable daily intake (TDI) is an estimate of the amount of a substance in food or drinking water which is not added deliberately (e.g contaminants) and which can be consumed over a lifetime without presenting an appreciable risk to health. ) 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 Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment. 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 Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. is scheduled for completion in 2018.

Background

The two studies reviewed in the RIVM report are:

• Menard, S. et al. (2014) Perinatal exposure to a low dose of bisphenol A impaired systemic cellular immune response and predisposes young rats to intestinal parasitic infection
• Menard, S. et al. (2014) Food intolerance at adulthood after perinatal exposure to the endocrine disruptor bisphenol A