Bacillus Strain Granted GRAS Status

CLEVELANDGaneden Biotech® has been granted GRAS status for its GanedenBC30® (Bacillus coagulans GBI-30, 6086), a spore-forming probiotic ingredient, for use in various food and beverage applications. GanedenBC30 is the first Bacillus strain to receive GRAS status.

GanedenBC30 safeguards the cell's genetic material from the heat and pressure of the manufacturing process. It easily incorporates into products, overcomes shelf-life challenges and withstands the acid and bile to which it's exposed during digestive transit.

GanedenBC30 is a probiotic intended for use in a wide variety of foods including, baked goods and baking mixes; beverages; cereals; gum; coffees and teas; condiments and relishes; confections and frostings; dairy product analogs; fats and oils; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, pudding and fillings; grain products and pastas; hard candy and cough drops; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candies; soups and soup mixes; sugars; and sweet sauces, toppings and syrups.

In 2007, Ganeden Biotech reached a self-affirmed GRAS determination for GanedenBC30,  which allowed it to sell to the food market. In 2010, it reaffirmed the status and later submitted the claim to FDA in 2011 with the guidance of the AIBMR Life Sciences, Inc. GanedenBC30 is currently found in more than 60 foods and numerous beverage categories including, baked goods, soup mixes, drink mixes, prepared foods, dairy, confectionery products and nutrition bars.

Click here for FDAs Response Letter GRAS Notice No. GRN 000399.