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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 987

2'-fucosyllactose

Intended Use: Intended for use as an ingredient in nonexempt infant formula for term infants at a maximum level of 2.4 g/L of formula, as consumed; in toddler formulas and meal replacement drinks for children ages 1 – 3 years at a maximum level of 2.4 g/L, as consumed; in infant and toddler foods at maximum levels of 10.0 g/L in drinks, 10.9 g/kg in ready-to-eat cereals and desserts, 12 g/kg in processed cereal-based food and other foods, and 57 g/kg in dry snacks; in beverages (sports and “energy” drinks, flavored waters, fruit juices and drinks, milk drinks, dairy analogs, and milk-based meal replacements) at maximum levels ranging from 0.8-6 g/L; in oral nutritional supplements and enteral tube feeding products at a level of 20 g/L; and in the following foods, at maximum levels ranging from 4.8-80 g/kg: breakfast cereals; frozen dairy desserts; puddings, fillings, mousses; yogurt and non-dairy analogs; meal replacement and snack bars; syrups; and jams and jellies.
Basis: Scientific procedures
Notifier: Amyris, Inc.
Notifier Address: 5885 Hollis Street, Suite 100
Emeryville, CA 94608
FDA's Letter: Pending

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