BPA review supports FDA position on safety

The National Toxicology Program (NTP) released a pre-peer review draft report​​ on findings of the two-year rodent study examining potential effects of BPA on health.

A peer-review meeting is planned for 26 April and will be open to the public.

The study, by scientists at the US Food and Drug Administration’s National Center for Toxicological Research (NCTR) and the National Institute of Environmental Health Sciences (NIEHS), is part of the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA).

Final CLARITY-BPA conclusions are expected in 2019.

FDA: BPA is safe​

The Food and Drug Administration (FDA) said an initial review supports its position that authorized uses of BPA in food containers and packaging continue to be safe for consumers.

“Overall, the study found “minimal effects” for the BPA-dosed groups of rodents,” ​said Stephen Ostroff, deputy commissioner for foods and veterinary medicine at FDA.

“The report also builds upon the already extensive data collected in the FDA’s 2014 assessment of the safety of BPA.​

“The report did identify some areas that may merit further research, such as the increase in occurrence of mammary gland tumors at one of the five doses, in one of the groups. But the significance of these findings will be assessed through the peer review process.”​

The draft report only includes data from the NCTR core study designed to look at the effects of several different doses of BPA evaluating chronic and early life exposure in two different groups of rodents.

Doses ranged from low - that would be comparable to typical human exposures - to those that vastly exceed exposures.

A variety of endpoints were evaluated including growth, weight and tumor development.

BPA produced minimal effects distinguishable from background in the study, particularly below 25,000 µg BPA/kg bw/day.

Many statistically significant BPA effects were not dose-responsive or only occurred in one dose group, suggesting normal biological variation.

The American Chemistry Council (ACC) said results ‘strongly support’ the safety of BPA.

“The results of the CLARITY Core study once again demonstrate that BPA is safe at the very low levels to which people are typically exposed​,” said Steven G. Hentges, Polycarbonate/BPA Global Group of the ACC.

“This study is the largest study ever conducted on BPA, and the results indicate that BPA has very little potential to cause health effects even when people are exposed to it throughout their lives.”​

Impact elsewhere​

Hentges said it looks forward to updated safety conclusions from regulatory authorities worldwide who have been awaiting the study results.

“Based substantially on the compelling body of US government research already available, government bodies around the world have clearly stated that BPA is safe as currently used in food contact materials.”​

Jasmin Bird, spokesperson of the Polycarbonate/BPA-group of PlasticsEurope, said: "This largest ever study conducted on the topic indicates that BPA has very little potential to cause health effects even when people are exposed to it throughout their lives."​

The European Food Safety Authority (EFSA) is to start work on re-evaluating BPA later this year due to new studies and scientific data to address remaining uncertainties.

A temporary Tolerable Daily Intake (t-TDI) of 4 μg/kg bw per day was set during the last evaluation.

The European Commission recently set regulation, which applies from 6 September 2018, to tighten restrictions on use of BPA in food contact materials (FCMs).

The migration limit has been strengthened 12-fold from 0.6 mg/kg to 0.05 mg/kg in food contact plastics.

The substance will also be prohibited in food contact varnished or coated materials for infants and young children.