[ Back to EurekAlert! ] Public release date: 11-Jan-2010
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia

Quality and safety of infant formulas, functional foods enhanced by new standards

Rockville, Md., January 11, 2010 — New standards to help ensure the quality and enhance the safety of key ingredients widely used in infant formulas and a variety of functional foods are being proposed for inclusion in the Food Chemicals Codex (FCC), an internationally recognized compendium of quality standards for food ingredients. The proposed standards are for three nucleotides, present in breast milk and commonly added to infant formula, and two docosahexaenoic acid (DHA) oils, essential omega 3 fatty acids present in fish and often added to both infant formula and a host of functional foods. The proposed standards are now available for public review and comment by industry and consumer representatives.

The standards will be incorporated into a future edition of the FCC, published by the U.S. Pharmacopeial Convention (USP), following a three-month period in which the scientific nonprofit organization will accept public comments on the proposals and consider any suggested modifications. FCC standards are voluntary industry standards that help ensure an ingredient's quality for consumers as well as for food manufacturers who purchase the ingredient for use in their products. Specifically, these quality standards are used to assess the identity, purity and impurities of an ingredient—allowing purchasers to feel confident that it is reasonably free of harmful contaminants, is consistent from one batch to the next and is, in essence, what it claims to be, i.e, it has not been diluted with water or otherwise tampered with through the addition or substitution of other, less-expensive ingredients.

Nucleotides are present in higher doses in human milk than in cow-based infant formulas—and are thus routinely added to infant formulas today. The three new nucleotide standards proposed for FCC inclusion are for Disodium 5'-Uridylate, 5'-Adenylic Acid and 5'-Cytidylic Acid. In addition to designating the identity, purity and impurities of the ingredients, the three new FCC standards include validated test methods that provide an accurate and repeatable means of measuring the ingredients' components, and corresponding reference materials, which are authenticated chemical specimens that ensure compliance to an FCC written standard. No such standards with validated test methods and corresponding reference materials currently exist for these ingredients within any food compendium.

"Consumers deserve to know the product they are feeding their infants contains ingredients that are pure and of high quality—as do manufacturers who seek to provide the best possible product to their customers," said James Griffiths, Ph.D., vice president of food, dietary supplement and excipient standards for USP. "These standards will serve to help advance the quality of these key ingredients."

The new standards being proposed for DHA oils are for DHA Algal Oil, Crypthecodinium Type and DHA Algal Oil, Schizochytrium Type. The first is used in infant formulas as well as for a wide variety of other products considered "functional foods" such as soy milk and yogurts; the second is used for functional foods but not in infant formula. No other food compendium contains standards for these two ingredients. Supplementing formulas with DHA as well as arachidonic acid (ARA) is supported by the World Health Organization at levels of 0.35 percent and 0.7 percent, respectively. U.S. infant formula manufacturers began to offer formulas containing DHA and ARA in 2002.

"In the modern manufacturing environment, food companies procure the ingredients they use in their finished products from facilities all over the world," Dr. Griffiths noted. "Within this highly competitive atmosphere in which suppliers seek to provide the most economical ingredients for purchase, the existence of and adherence to quality standards for ingredients can be a significant protection in guarding against substandard ingredients—and one of the safety nets for the food supply."

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Invitation to Comment

As part of its open and transparent process, proposed new and revised FCC standards are open to any interested parties via the FCC Forum—the online mechanism through which USP accepts public comment on standards to be included in the FCC. Manufacturers, consumers and others are encouraged to visit www.usp.org/fcc/forum/ to review these new standards and provide scientific feedback. These comments will be considered by USP's Food Ingredients Expert Committee, a group of independent scientific experts that oversees FCC standards. Comments will be accepted through March 31, 2010, and final standards will be published August 31, 2010.

For more information, please visit www.usp.org/fcc/.

USP—Advancing Public Health Since 1820

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are recognized and used worldwide. For more information about USP visit http://www.usp.org.



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