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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 864

Bacillus coagulans SNZ 1969 spore preparation

Intended Use: As an ingredient in non-exempt infant formulas for term infants, at levels up to 2 x 108 colony forming units (CFU) per 100 mL infant formula, as consumed.
Basis: Scientific procedures
Notifier: Sanzyme Biologics Pvt. Ltd.
Notifier Address: Plot No. 13, Sagar Society, Banjara Hills, Road Number 2 Hyderabad 500 034, Telengana
GRAS Notice (releasable information): GRN 864 with amendments (in PDF) (8.3 MB)
Date of closure: Feb 6, 2020
FDA's Letter: FDA has no questions (in PDF) (560 kB)