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Critical quality considerations for probiotics offered in new draft FCC standards

Rockville, Md. -- With strong consumer interest in probioticsand new manufacturer innovations for incorporating these ingredients into a broader array of food productsnew standards to help ensure the quality of probiotic food ingredients are being proposed for public review and comment. The draft standards, which will be included in the Food Chemicals Codex (FCC), offer comprehensive information that is essential when utilizing probiotics as food ingredients, including testing to confirm the identity upon which probiotic product safety and health claims are based. Published by the U.S. Pharmacopeial Convention (USP), FCC is an international compendium of quality specifications for food ingredients.

Essential quality specifications such as identification and enumeration (microbe count), as well as intended uses in food, safety, regulatory status and purity of probiotics and other microbial food cultures, are included in the new FCC Appendix, titled Microbial Food Cultures Including Probiotics. These specifications are available in the latest FCC Forum, the free-access, online vehicle through which proposed FCC standards are published for public review and comment (see

Proper identification with probiotics is important because safety studies are most often based on the genus/species or strain level, so it is critical that manufacturers know exactly which microorganism they are incorporating into their food product to ensure safety. Identification also is important in supporting purported health claims. Given that many different strains of microorganisms are cultured and have been tested and used in foods, any supporting studies for justifying health claims are at the specific strain level. For any claimed health benefit, manufacturers should be able to confirm that what they are using in a probiotic food product is indeed the strain tested. Enumeration is similarly important because any claimed health effects supported by study trial data would also be specific to the level of intake.

Future standards development work at USP will potentially include individual monograph (written) standards for specific probiotic strains, combined with more prescriptive details for identification and enumeration of the microorganisms of interest.

"Testing for identity is difficult with probiotics, and this is a key area where public standards provided in the Food Chemicals Codex can be of significant value across the food, nutritional and consumer products industries," said Praveen Tyle, Ph.D., USP's chief science officer. "These are standards that all parties can use. With more manufacturers incorporating probiotics in products beyond yogurts based on rising consumer interest, scrutiny of health claims will grow, as will global sourcing of ingredients. We believe additional measures for determining identity and overall quality will be useful in protecting consumers and manufacturers alike."

The latest FCC Forum includes other proposed standards for public review, including:

Steviol GlycosidesNew standards for the popular natural stevia sweeteners. A monograph for high-purity Rebaudioside A already exists in FCC, but the new Steviol Glycosides monograph covers a broader range of stevia-derived ingredients including mixtures of different steviol glycosides, which are being increasingly utilized in foods and beverages. An important component of the standard is a newly developed method capable of separating and measuring all nine glycosideswhich has been difficult in the past. USP will have seven reference standards available to support the monograph in the near future.

BenzoatesModernized standards for three benzoates to help address concerns about economically motivated adulteration. Widely used as preservatives, the three ingredientscalcium benzoate, potassium benzoate and sodium benzoatewere modernized with more specific identification tests and/or assay tests. In sourcing commercially available samples of calcium benzoate, USP laboratory staff was able to detect the adulteration of a commercial sample of allegedly pure calcium benzoate with calcium propionate by using the modernized monograph's purity criteria. This is the goal of modernizing such monographsto create effective tools to deal with the threat of economically motivated adulteration by better specifying what should be present without testing for specific known adulterants ( i.e., what shouldn't be in an ingredient).

Infant Formula, Flavoring IngredientsContinuing a commitment to develop monographs for infant formula ingredients, proposed FCC standards are available for chromic chloride and sodium selenate anhydroussources of minerals chromium and selenium, respectively, used in baby formula. This follows the addition of a variety of infant formula ingredients in the FCC over the past several years, including a focus on all micronutrients used in these products. For these infant formula ingredients, no known standards exist in any other compendium. Also included in the latest FCC Forum are 11 flavoring agents used in foodsanother area where public monographs and/or reference standards are needed.

Contact: Francine Pierson
US Pharmacopeia

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