Probiotic Monograph Will Be First Ever for Food Chemicals Codex


The monograph is specific to the Bacillus Coagulans GBI-30, 6086 bacterial strain.

The first-ever probiotic monograph for the Food Chemicals Codex is now in draft form and accepting public comments. This is the first new FCC monograph the U.S. Pharmacopeial Convention (USP; Rockville, MD) has proposed in 2014. Once finalized, it will publish in the FCC’s ninth edition.

Manufacturers and industry members have until March 31, 2014, to comment on the newly proposed monograph via the FCC Forum. FCC monographs set ingredient-specific quality standards to guide food manufacturers.

The probiotic monograph is specific to the probiotic strain Bacillus coagulans GBI-30, 6086. (Cleveland-based probiotic ingredient supplier Ganeden Labs markets its patented Ganeden BC30 Bacillus coagulans GBI-30, 6086, ingredient.) This Gram-positive bacterial strain is increasingly used in food products in recent years because its spore-forming nature can withstand rigorous food processing conditions such as heat, compared to other bacterial strains. So far, the strain has been used in a variety of food products, including baked goods, coffee and tea, dairy products, and pasta. In 2012, it became the first Bacillus bacterial strain to receive FDA’s GRAS notification. Bacillus coagulans GBI-30, 6086, shows digestive and immune health benefits in clinical tests.

USP says this is the first proposed FCC monograph for a probiotic type of microbial food culture.

USP has also proposed a new identification tool for skim milk powder to address market adulteration with nitrogen-rich chemicals such as melamine. The new tool tightly defines the amount of non-protein nitrogen skim milk powders should contain.

USP is also developing new reference standards for skim milk powder, includingUSP Skim Milk Powder and USP Skim Milk Powder with Melamine – Level D. “USP Skim Milk Powder with Melamine – Level D is the first reference standard in the history of USP that was produced by intentionally spiking liquid milk with a specific level of melamine before spray-drying the milk to produce a milk powder containing a specified amount of melamine. This production process of this reference standard has been designed to mimic as closely as possible the way skim milk powder is expected to have been illegally adulterated,” USP says. USP says its reference standards also protect against other future adulterants besides melamine.

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