5 December 2007
IFC’s position:
No changes in feeding practices for infants are recommended. Parents and health professionals can be assured infant formula is safe and nutritious.
Food & Drug Administration’s (FDA) position:
According to the FDA’s Mitchell Cheeseman, Ph.D., deputy director of the Office of Food Additive Safety, “We do not have a reason at this point to change our opinion that bisphenol A is safe.” 6 Thus, the FDA upholds their previous position that BPA is safe for humans. Additionally, BPA has been used in consumer products for over 50 years. In that time, there has been no evidence that BPA is harmful to humans, either as the result of dietary intake or industrial worker exposures.”
Background:
Bisphenol A is a substance used in the production of certain polycarbonate (clear) plastic products, including baby bottles, plastic wrap, and metal can coatings.
Based on numerous safety tests, the FDA permits the use of bisphenol A (BPA) in clear plastics for all types of foods including infant formula. Regarding baby bottles, one 1997 FDA study concluded that, under conditions of typical consumer use, there was no migration of BPA from the bottle into its contents; the methodology had a detection limit of 2 parts per billion.1
Recently, a consumer group has made allegations of BPA’s potential health threat to infants consuming baby formula from plastic bottles and canned containers. These allegations are largely based on research suggesting that BPA may increase the potential for adverse reproductive and developmental effects when fed to laboratory animals. The Environmental Working Group (EWG), through an independent laboratory, found BPA in 55 of 97 cans of food tested, some of which were infant formula. The EWG tested 6 cans of milk- and soy-based infant formulas from two different infant formula manufacturers and BPA was detected in 2 of the cans.2 The BPA concentration of the can contents ranged from non-detectable (ND) to 17.1 parts per billion (ppb)-far below what is considered potentially harmful to humans.3 These findings were not published in a peer-reviewed journal, nor was the methodology clearly presented in the report.
In 2006, The European Food Safety Authority (EFSA) reviewed the large number of BPA studies in animals (including the same “low-dose” studies cited by the EWG as evidence of harm) and found that the levels of BPA described by the EWG report are safe.3 A key finding from this EFSA review is that humans clear BPA from the body more rapidly than do rats or mice, thereby considerably lowering the potential for toxicity. This factor must be appropriately considered when attempting to extrapolate the results of animal toxicology studies to humans. The current United States Environmental Protection Agency (EPA) oral reference dose (RfD) for the safe intake of BPA is 50 mg/kg body weight/day, which is in agreement with the European Food Safety Authority’s Tolerable Daily Intake (TDI).3, 4 Given that only one out of three formula cans in the EWG study contained a measurable amount of BPA and that the highest level reported would translate into an intake of 2.4 mg/kg body weight/day for the reference infant mentioned in their report (which is 20 times less than the RfD/TDI of the EPA and EFSA respectively), the risk of adverse health effects from these levels of BPA is minimal.
In August 2007, the National Toxicology Program-Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) held an Expert Panel meeting to discuss and draft an Expert Panel Report on BPA. BPA was non-detectable in almost all studies of plastic bottles and non-detectable to very low in two of the three studies of canned infant formula being considered by the Expert Panel.5 With respect to infants and children, the NTP-CERHR two page provisional summary concluded that:
*There is “some concern that exposure to BPA causes neural and behavioral effects.”
*There is “minimal concern that exposure to BPA potentially causes accelerations in puberty.”
The criteria was based on a five point scale, with a ranking of five reflecting the most serious threat and a ranking of zero reflecting a negligible threat. The evidence supporting the conclusion of “some concern” scored three out of five points and the evidence supporting the conclusion of “minimal concern” was given one out of five points by the panel.
References Cited:
1 Biles, JE et al. Determination of bisphenol-A in reusable polycarbonate food-contact plastics and migration to food-stimulating liquids. Journal of Agricultural and Food Chemistry. 1997; 45: 3541-3544.
2 The Environmental Working Group unpublished results. Bisphenol A: Toxic Plastics Chemical in Canned Food: A Survey of Bisphenol A in U.S. Canned Foods. 2007
3 European Food Safety Authority. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to
2,2-BIS (4-HYDROXYPHENYL)PROPANE (Bisphenol A). The EFSA Journal. 2006; 428: 1-75.
4 The United States Environmental Protection Agency Integrated Risk Information System. Bisphenol A. (CASRN 80-05-7) 1993
5 National Toxicology Program Center for the Evaluation of Risks to Human Reproduction Expert Panel: Draft Report: Evaluation of Bisphenol A. August 2007.
6 Merle, R and Mui, YQ. "For Parents, Bottle Safety Still Unclear: Plastic's Harm Isn't Proven, But Toy Recalls Stir Fears.” The Washintgon Post 22 Aug. 2007, natl. ed.:D01.