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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 951

3-fucosyllactose

Intended Use: Intended for use as an ingredient in cow milk-based and soy-based non-exempt infant formula for term infants and formula intended for young children aged 1-3 years at a level of 0.04 g/serving (0.44 g/L) as consumed; juices, drinks, and foods for infants and young children under 3 years of age at levels ranging from 0.03 to 0.09 g/serving (0.44 to 4.4 g/kg); cereal and nutrition bars; enhanced and fortified waters; energy and sport drinks and mixes; breakfast cereals; milk substitutes; yogurts; fermented milk, flavored milk, and mixes; smoothies; milk-based meal replacement beverages; fruit juices and nectars (including fruit-based beverages); vegetable juices; and in oral and enteral tube feeding formulas at levels ranging from 0.07 to 0.88 g/serving (0.26 to 8.8 g/kg).
Basis: Scientific procedures
Notifier: Danisco, USA
Notifier Address: DuPont Experimental Station - E320
200 Powder Mill Road
Wilmington, DE 19803
GRAS Notice (releasable information): GRN 951 with amendments (in PDF) (5.7 MB)
Date of closure: Aug 12, 2021
FDA's Letter: FDA has no questions (in PDF) (272 kB)
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