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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1003

Bifidobacterium longum subsp. infantis M-63

Intended Use: Intended for use as an ingredient in non-exempt cow milk- and soy-based infant formula for term infants at a level up to 1 x 108 colony forming units (CFU)/g of powdered formula, and in certain conventional foods in the following categories at a level up to 1.25 x 1010 CFU per serving: breads and baked goods; ready-to-eat and hot breakfast cereals; fruit juices, nectars, and blends; dairy products and dairy substitutes; candy; condiment sauces; gelatin desserts; peanut and other nut butters and spreads; snack foods; and infant and toddler foods.
Basis: Scientific procedures
Notifier: Morinaga Milk Industry Co., Ltd
Notifier Address: 33-1, Shiba 5-Chome, Minato-ku
Tokyo 108-8384
JAPAN
GRAS Notice (releasable information): GRN 1003 with amendments (in PDF) (2.3 MB)
Date of closure: Apr 26, 2022
FDA's Letter: FDA has no questions (in PDF) (75 kB)

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