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BPA and Liquid Infant Formula Packaging

in
For Immediate Release
January 15, 2010
Marisa Salcines
Mardi Mountford
info@infantformula.org
(404) 252-3663

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IFC Statement on BPA and Liquid Infant Formula Packaging

International Formula Council Statement on BPA and Liquid Infant Formula Packaging

On January 15, the U.S. Food and Drug Administration (FDA) reaffirmed the safety of BPA for use in all food contact applications, noting studies employing standardized toxicology tests support safety at current low levels of human exposure. However, FDA agreed with the National Toxicology Program (NTP) that recent studies employing novel approaches designed to test for subtle effects have raised “some concern” about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children, and so is working with NTP to carry out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA. 

FDA reiterated BPA is safe in all of its current uses and noted that families should not change their infant feeding practices, including the use of infant formula. FDA added “the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.”
 
The infant formula industry takes all potential safety concerns very seriously, and we support science-based efforts to produce infant formula products of the highest possible quality. When new information becomes available on substances like BPA, we support bringing that information forward through the accepted process of scientific peer review and evaluation. In the meantime, the International Formula Council* (IFC) and its members remain committed to working in collaboration with government and regulatory authorities to protect the health and safety of infants worldwide.
 
The U.S. Food and Drug Administration (FDA), the California Environmental Protection Agency’s Office of the Environment and Health Hazard Assessment, the Canadian government, the European Food Safety Authority, Food Standards Australia New Zealand, the Japanese National Institute for Advanced Industrial Science and Technology and others have consistently stated that there is no health risk associated with the trace amounts of BPA that potentially can be detected in infant formula. 
 
The primary focus of the IFC and its member companies is and will always remain the health and welfare of infants and children around the world. The product we manufacture, infant formula, is the most highly regulated food in the world. While the scientific evidence continues to support the safety of BPA, the infant formula industry is partnering with our food packaging suppliers to minimize trace levels of BPA that may be contained in current packaging. Simultaneously, we are working with the packaging industry as well as the FDA and the Canadian government to aggressively research and identify possible alternatives to current packaging.
 
Each of these steps takes time.  Switching to alternative packaging is not a simple process and could take years. Just as packaging suppliers must work with regulators to identify, certify and make commercially available alternatives to the current epoxy-lined metal cans, our industry must also go through a number of steps to ensure that any new packaging materials continue to provide at least the same level of quality and safety provided by our current packaging.
 
Today’s infant formula packaging provides critical protection to maintain the quality of both the container and the nutrients for a given period of time (known as shelf life) that has been well established over years of testing. Specifically, the current epoxy liners in metal infant formula cans protect the product from the metal can and from other environmental factors. These protections are critical in preventing corrosion or environmental contamination, as well as ensuring nutrient stability, product quality and aesthetic features such as flavor and aroma – throughout the product’s shelf life. The FDA requires that all of these factors must be accounted for before a manufacturer can utilize an alternative package. Additionally, in order to fully evaluate how well the packaging protects the product, chemical tests of product ingredients must be conducted over the course of the intended shelf life to ensure that the nutrient levels declared on the label are accurate. Although we would like to speed up these processes, it is important to note that shelf life testing may require years to fully complete.
 
Once a package is found to be viable, the process doesn’t stop there. Commercialization of new packaging materials means infant formula manufacturers must modify their production lines in a variety of ways - exactly how those modifications may occur will depend on individual manufacturing processes. All manufacturers would have to make some form of change. Any packaging alternatives will be subject to ongoing safety and quality evaluations as required by law (i.e., the Infant Formula Act).
 
In addition to minimizing potential BPA migration into infant formula products and seeking suitable alternatives to current packaging, we have encouraged the FDA and the Canadian government to explore establishing (1) a uniform acceptable level of BPA in infant formula products and (2) a validated testing method for BPA, and they are addressing these issues. To help the public interpret the data, FDA should define a level of concern for quantifiable BPA levels to provide meaningful guidance to consumers and manufacturers on the safety of food products. A standard BPA test method with defined detection and quantification limits is necessary to improve consumer understanding and to assist suppliers and retailers to manage packaging transitions. The public remains concerned and confused about this issue largely because of conflicting reports about studies assessing the safety of BPA. We support efforts to identify an available alternative to current packaging. However, in the interim, a clearly defined safety level and testing method would provide important information to the public that current packaging is safe – and is in accordance with limits set by national and international regulatory agencies while suitable alternative packaging is being developed.
 
In summary, IFC and its members support all efforts being conducted by food packaging suppliers and regulatory agencies both to minimize potential BPA migration into infant formula products and to identify suitable alternatives to current packaging. IFC also supports the thorough assessment approach currently utilized by FDA and numerous world-wide regulatory agencies (e.g., Canada, Europe, and
Japan). This standard, multi-step, evidence-based scientific review process to establish a sound risk assessment is based on well-defined criteria, and continues to support the safety of BPA.
 
Parents and health professionals can be assured infant formula is safe and nutritious.
*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 Nutrition; Nestlé Infant Nutrition; and Pfizer Nutrition.