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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 454

Bifidobacterium breve M-16V

Intended Use: As an ingredient in non-exempt powdered term infant formulas (milk- or soy-based) and exempt powdered term infant formula containing partially-hydrolyzed milk or soy proteins, at levels up to 108 colony forming units per gram of infant formula powder
Basis: Scientific procedures
Notifier: Morinaga Milk Industry Co., Ltd
Notifier Address: 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384, JAPAN
Date of filing: Jan 22, 2013
GRAS Notice (releasable information): GRN 454 (in PDF) (16.6 MB)
Date of closure: Sep 27, 2013
FDA's Letter: FDA has no questions