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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1091

2'-fucosyllactose

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants and formula intended for young children (>12 months) at up to 2.4 g/L; foods intended for infants and young children at up to 57 g/kg, drinks for young children at up to 10 g/L; in non-alcoholic beverages (sports and "energy drinks", enhanced and fortified waters, fruit juices and nectars, fruit-flavored drinks, vegetable juices, milk, flavored milk, milk substitutes, smoothies and meal replacements, and nutritional drinks for pregnant women) at up to 6.0 g/L; in oral nutritional supplements and enteral tube feeding products at 20 g/L; and in the following food categories at maximum levels in the range of 7.0 to 80 g/kg: hot cereals; ready-to-eat cereals; cereal and granola bars; buttermilk; flavored milks; yogurts; frozen dairy desserts; puddings, custards, and mousses; fruit fillings; cereal and granola bars (including meal-replacement bars); jams, jellies, fruit preserves and fruit butters; yogurt (including non-dairy yogurt); and syrups used to flavor milk beverages.
Basis: Scientific procedures
Notifier: Inbiose N.V.
Notifier Address: Technologiepark 82 - bus 41
B-9052 Zwijnaarde
Belgium
GRAS Notice (releasable information): GRN 1091 with amendments (in PDF) (2.1 MB)
Date of closure: Dec 1, 2023
FDA's Letter: FDA has no questions (in PDF) (272 kB)
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