Quality and Safety of Infant Formulas, Functional Foods Enhanced by New Standards for Nucleotides, DHA Oils

ROCKVILLE, Maryland, January 13 - 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 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 USP will accept public comments on the proposals and consider
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.

Nucleotides are routinely added to infant formulas today. The three new
nucleotide standards proposed are for Disodium 5'-Uridylate, 5'-Adenylic Acid
and 5'-Cytidylic Acid. The three 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.

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 ingredients.

"In the modern manufacturing environment, food companies procure the
ingredients they use in their finished products from facilities all over the
world," said James Griffiths, Ph.D., USP vice president of food, dietary
supplement and excipient standards. "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."

Proposed FCC standards are open to any interested parties via the online
FCC Forum. Manufacturers and others are encouraged to visit
www.usp.org/fcc/forum/. Comments will be accepted through March 31, 2010, and
final standards will be published August 31, 2010.

The seventh edition of the FCC will publish in February 2010. For more
information, visit www.usp.org/fcc/.

Francine Pierson of U.S. Pharmacopeial Convention, +1-301-816-8588; fp at usp.org