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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 875

Bifidobacterium animalis subsp. lactis AD011

Intended Use: Intended for use as a food ingredient in non-exempt term infant formula (milk-, soy-, and whey-based); and foods (dairy products/dairy-based foods and dairy substitutes, including fermented milk including butter milk and kefir; flavored milk beverage mixes; dried milk powder; imitation milk and yogurt; powdered baby cereals and foods; meal replacement and nutritional drink mix powders; and powdered sugar substitutes) for the general population. Powdered non-exempt term infant formulas (milk-, soy-, or whey-based) will contain up to 108 colony forming units (CFU) of B. lactis AD011 per gram of powdered formulas; and the other foods will contain up to 1010 CFU B. lactis AD011 per serving.
Basis: Scientific procedures
Notifier: BIFIDO CO., LTD.
Notifier Address: 23-16, Nonggongdanji gil, Hongcheon-eup
Hongcheon-gun, Gangwon-do,25117
Republic of Korea
GRAS Notice (releasable information): GRN 875 (in PDF) (2.8 MB)
Date of closure: Oct 30, 2019
FDA's Letter: At the notifier's request, FDA ceased to evaluate this notice (in PDF) (258 kB)
Resubmitted as GRN No.: 952