Food Safety

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

New standards are being considered for the Food Chemicals Codex.


To help ensure the quality and enhance the safety of key ingredients widely used in infant formulas and a variety of functional foods, new standards are being proposed for inclusion in the (FCC). 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 functional foods). The proposed standards are now available for review and comment by industry and consumer representatives.

The standards will be incorporated into a future edition of the FCC, published by the US 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’s industry standards help ensure an ingredient’s quality for consumers as well as for food manufacturers who purchase the ingredient for use in their products.

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 repeatable means of measuring the ingredients’ components.

The new standards being proposed for DHA oils are for DHA algal oil, Crypthecodinium Type and DHA algal oil, Schizachyrium 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. US infant formula manufacturers began to offer formulas containing DHA and ARA in 2002.

Proposed new and revised FCC standards are open to any interested parties via the FCC Forum. Manufacturers, consumers and others are encouraged to visit the FCC Forum to review the new standards and provide scientific feedback. 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, and final standards will be published August 31.

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