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International Formula Council (IFC) Supports Sound Science as Criteria for the Use of Bisphenol A (BPA)

IFC’s* position:
Media attention on the use of bisphenol A (BPA) in food packaging has raised some questions regarding infant formula.  The safety of BPA is supported by the U.S. Food & Drug Administration (FDA), European Food Safety Authority (EFSA), U.S. Environmental Protection Agency (EPA), and the Japanese National Institute for Advanced Industrial Science and Technology.  Government and scientific bodies worldwide have reviewed the science on BPA and none have banned or restricted its use; all support the conclusion that BPA is not a risk to human health.  Based on these reviews, no changes in feeding practices for infants are recommended.

BPA is used in food packaging to make polycarbonate plastic and epoxy can coatings.  These materials have been extensively studied and are approved for use in direct contact with food by national and international regulatory bodies and have been used safely in food contact applications for over 50 years.  BPA is not an ingredient in infant formula; it is only present in trace amounts in some of the packaging of canned foods, such as infant formula.

Regarding infants, a recent review performed by the EFSA Expert Panel, which “gave special attention to infants and children,” noted that infants would need to consume hundreds of times the amount of BPA found in canned food to approach any safety concerns.¹

As an industry, members of the IFC take all safety issues very seriously.  Our research and development programs are targeted to produce the highest quality of infant formula products available.  When new information becomes available on substances like BPA, we support bringing the information forward through the accepted process of scientific peer review and evaluation.  This helps ensure that it is evaluated with consideration to existing science and that policies are driven by sound science.

Parents and health professionals can be assured infant formula is safe and nutritious.

U.S. 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.”²  Thus, the FDA upholds its 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.

European Food Safety Authority (EFSA) and the U.S. Environmental Protection Agency’s (EPA) positions:
In 2006, EFSA reviewed the large number of BPA studies in animals and found that the levels of BPA currently used in packaging are safe.¹  EFSA found that the potential BPA exposure of infants and children is well below the level that is considered safe to ingest daily over the course of a lifetime.  The current EPA oral reference dose (RfD) for the safe intake of BPA is 50 µg/kg body weight/day, which is in agreement with EFSA’s Tolerable Daily Intake (TDI).^1,3  

Japanese National Institute for Advanced Industrial Science and Technology’s position:
Also in 2006, a comprehensive risk assessment was completed by the Japanese government, which found that “current exposure levels of BPA will not pose any unacceptable risk to human health.”⁴  The panel concluded that it was unnecessary to prohibit or restrict the use of BPA.  The assessment was conducted by scientists at the National Institute of Advanced Industrial Science and Technology, a public research organization affiliated with the Japanese Ministry of Economy, Trade, and Industry.

Background:
BPA is a substance used in the production of epoxy resins and certain polycarbonate (clear) plastic products, plastic wrap, and metal can coatings. 

Based on numerous safety tests, the FDA permits the use of BPA in clear plastics and metal can coatings for all types of foods including infant formula. 

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 final report concluded that:

• There is a "minimal" concern for acceleration of puberty in infants and children due to a lack of reproducibility of low dose effects of BPA, the absence of toxicity in those low-dose-affected tissues at high doses, and the uncertain adversity of the reported effects.
• There is "some" concern for neural and behavioral effects in infants and children since the overall findings suggest that BPA may be associated with neural changes in the brain and behavioral alterations related to sexual dimorphism in rodents.
• More longitudinal studies in humans are needed that use the appropriate route of exposure (oral) and examine conjugated BPA and its other metabolites, as they occur in humans.

Recently, a consumer group has made allegations of BPA’s potential health threat to infants consuming baby formula from plastic bottles and from metal containers coated with epoxy resins.  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.  However, humans metabolize and excrete BPA from the body more rapidly than do rats or mice, thereby considerably reducing the potential for any harmful effects.¹

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. ⁶  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.  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.^1,3 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 µg/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. Furthermore, these findings were not published in a peer-reviewed journal, nor was the methodology clearly presented in the report.

Parents and health professionals can be assured that the U.S. infant formula industry is committed to providing products that are safe and nutritious for infants and young children and will continue to evaluate scientific findings as they become available.

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*The IFC is an association of manufacturers and marketers of formulated nutrition products, e.g., infant formulas and adult nutritionals, whose members are based predominantly in North America.  IFC members are: Abbott Nutrition; Mead Johnson Nutritionals; Nestle Nutrition - USA; and Wyeth Nutrition.

References Cited:
1 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. http://www.efsa.europa.eu/en/science/afc/afc_opinions/bisphenol_a.html

2 Merle, R and Mui, YQ. "For Parents, Bottle Safety Still Unclear: Plastic's Harm Isn't Proven, But Toy Recalls Stir Fears.”  The Washington Post 22 Aug. 2007, natl. ed.:D01.

3 The United States Environmental Protection Agency Integrated Risk Information System.  Bisphenol A. (CASRN 80-05-7) 1993; http://www.epa.gov/IRIS/subst/0356.htm

4 Japanese National Institute of Advanced Industrial Science and Technology Research Center for Chemical Risk Management; Bisphenol A Risk Assessment Document.
http://unit.aist.go.jp/riss/crm/mainmenu/e_1-10.html

5 National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction.  NTP-CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Bisphenol A.  November 2007. 
http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPAFinalEPVF112607.pdf

6 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. www.ewg.org/book/export/html/20928

More Information on BPA

European Food Safety Authority: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_BisphenolAFAQs.htm

North American Metal Packaging Alliance (pdf)

Bisphenol-A Web site: http://www.bisphenol-a.org/index.html

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