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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 601

Bacillus coagulans SBC37-01 spore preparation

Intended Use: Intended for use as an ingredient in the following food categories: 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; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; 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 candy; soups and soup mixes; sugar; and sweet sauces, toppings, and syrups at a maximum level of approximately 2 x 109 colony forming units (CFU)/serving (reference amounts customarily consumed, 21CFR 101.12).
Basis: Scientific procedures
Notifier: Sabinsa Corporation
Notifier Address: 750 Innovation Circle, Payson, UT 84651
Date of filing: Oct 5, 2015
GRAS Notice (releasable information): GRN 601 (in PDF) (10.3 MB)
Date of closure: Apr 28, 2016
FDA's Letter: FDA has no questions