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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 831

Bacillus subtilis DE111

Intended Use: Ingredient in cows-milk and soy-based non-exempt infant formula for term infants at a maximum level of 2 x 10^8 colony forming units (CFU)/100 mL and in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fats and oils; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; soft/hard candy and cough drops; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk and milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soups and soup mixes;1 sugar; and sweet sauces, toppings, and syrups at levels from 1 x 10^6 to 1 x 10^10 CFU/serving.
Basis: Scientific procedures
Notifier: Deerland Probiotics and Enzymes
Notifier Address: 3800 Cobb International Blvd
Kennesaw, GA 30152
GRAS Notice (releasable information): GRN 831 with amendments (in PDF) (6.4 MB)
Date of closure: Aug 13, 2019
Date of FDA’s corrected letter: Oct 7, 2019
FDA's Letter: FDA has no questions (in PDF) (73 KB)