The European Food Safety Authority (EFSA) has temporarily lowered the tolerable daily intake (TDI) of bisphenol A (BPA) pending the outcome of US research.
EFSA said that the tolerable daily intake (TDI) should be lowered from 50 micrograms per kilogram of body weight per day to 5 micrograms, in the first of a two part assessment.
The US National Toxicology Program (NTP) is aiming to address uncertainties about the health effects of BPA but a publishing date of the research is unknown.
EFSA said that the health risk is low because the highest estimates for combined oral and non-oral exposure are 3-5 times lower than the temporary TDI, depending on the age group.
The agency added much of the science underpinning the conclusions is still developing and the draft opinion contains a number of uncertainties.
The verdict comes after the agency held a consultation on the draft opinion of the consumer exposure.
EFSA’s scientific experts provisionally concluded that diet is the major source of exposure, which is lower than previously estimated.
More than 450 studies were reviewed relating to potential health hazards associated with BPA and that exposure is likely to affect the kidney and liver, and cause effects on the mammary gland.
The opinion considers the possible effects on the reproductive, nervous, immune, metabolic and cardiovascular systems, as well as in the development of cancer.
While an association between BPA and these other effects is not considered likely at present, EFSA concludes they may be of potential concern and add to the uncertainty about the risks of the substance.
Not a concern
Members of the Polycarbonate/BPA and Epoxy Resin groups of PlasticsEurope said EFSA’s opinion confirms that the chemical is not a concern for human health.
“This is consistent with the findings of other regulatory agencies across the globe, such as the recent US Food and Drug Administration, which concluded in March 2013 that “BPA is safe at the very low levels that occur in some foods”, and also with EFSA´s earlier assessments of BPA.
“The panel concluded that the exposure even for the highest exposed groups in the population is well below the t-TDI of 5 μg/kg bw per day, indicating that the health concern for BPA is low at the current level of exposure.”
Part 2 of the assessment
Part two will consult on the human health aspects of its risk assessment with public comment possible until 13 March 2014.
EFSA will publish its final scientific opinion after considering both parts of their assessments reports and comments, expected later this year.
“When EFSA publishes its opinion on BPA – following consideration of comments received from these consultations – the Food Standards Agency will consider, along with the European Commission and EU member states, whether action is necessary to protect consumers,” said the UK Food Standards Agency.
Steven G. Hentges, Ph.D. of ACC’s Polycarbonate/BPA Global Group, said the findings reaffirm that consumer exposure to BPA poses a low health risk.
“The overall conclusion was based on a thorough and cautious scientific approach. The expert panel noted that its safe limit, known as a tolerable daily intake, was ‘very conservatively derived,’ and the highest potential consumer exposure was used to assess risks.
“The conclusions of EFSA and FDA are supported by extensive research funded and conducted by US government laboratories. For example, the US Environmental Protection Agency has funded recent, robust research conducted by scientists at FDA, the Centers for Disease Control and Prevention and the government’s Pacific Northwest National Laboratory.”
The North American Metal Packaging Alliance (NAMPA) welcomed the EFSA opinion concluding BPA is not a health concern.
"As one of the world’s leading authorities on food safety, the EFSA draft opinion should offer reassurance to consumers that even with a lowered safety level, the use of BPA in metal packaging does not pose a risk to people of any age,” said Dr John M. Rost, NAMPA chairman.