USP proposes monograph on specific bacillus coagulans probiotic strain

By Hank Schultz

- Last updated on GMT

Related tags Melamine Milk

USP proposes monograph on specific bacillus coagulans probiotic strain
For the first time, the United States Pharmacopoeia is proposing a monograph on a probiotic organism as a food ingredient in the latest series of draft monographs put forward for inclusion in the Food Chemicals Codex.


The monograph pertains to the specific strain, in this case Ganeden’s proprietary strain of bacillus coagulans branded as GanedenBC30. This is the first proposed FCC monograph for a probiotic type of microbial food culture. According to the USP statement, “Bacillus coagulans GBI-30, 6086 is a Gram-positive, spore-forming bacterium, classified as a probiotic for its purported support to good digestive and immune health, and was the first bacillus to receive a GRAS (Generally Recognized as Safe) notification in 2012 from the U.S Food and Drug Administration (FDA). It can be used in a variety of foods, including baked goods and baking mixes, breakfast cereals, coffee and tea, dairy products, grain products and pastas, among others.

“Because of the unique characteristics of food ingredients comprised of live microorganisms, the proposed monograph is specific to the strain level and represents only food ingredients that are labeled as this specific strain of Bacillus coagulans,”​ the statement added.

“USP has been wanting to do a general probiotic monograph for a while,” ​ Mike Bush, vice president of Ganeden, told NutraIngredients-USA. “As far as we know, we were the only company participating in the full submission.”

“This is important because it is independently validated but, more importantly, published. It just takes it one step further to allow us to further characterize the organism. It became obvious very early that any kind of health claims are attached to a strain and not a species,”​ Bush said.

Melamine in milk

In addition to the probiotic monograph, USP is proposing a monograph that will help testers find melamine contamination in skim milk powder.  Melamine spiking can give an artificially high protein reading. The method, called Non-Protein Nitrogen Determination for Skim Milk Powder is a simple identification tool that selectively measures and tightly defines the amount of non-protein nitrogen that authentic skim milk powders should contain, thereby excluding materials that are intentionally adulterated with nitrogen-rich chemicals like melamine.

USP says it is developing new reference standards to support the monograph, including USP Skim Milk Powder, and USP Skim Milk Powder with Melamine – Level D. These USP reference standards will be employed as a system suitability reference standard to verify that the method is performing correctly.

USP Reference Standards for food ingredients are highly-characterized physical specimens used to help guarantee their identification and quality. USP Reference Standards for food ingredients are closely tied with the documentary standards published in the FCC.

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. USP says 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.

Both reference standards are the first in a series of new tools that are being developed by USP’s Skim Milk Powder Advisory Group aimed at protecting the food supply from economic adulteration with not only melamine and other known milk adulterants, but also new, yet unknown, adulterants that may be used in the future.

In addition to the above monographs, USP is also releasing a draft version of a monograph covering chromium picolinate and chromium chloride.  The proposed monographs be viewed on the FCC Forum​ and are open for  a 90-day comment period, which ends on March 31, 2014.

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