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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1051

2'-fucosyllactose

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 2.4 g/L of formula as consumed; in toddler formulas intended for children ages 1-3 years at a level of 2.4 g/L, as consumed; in other infant and toddler foods at maximum levels of 10.0 g/L in drinks, 10.9-12 g/kg in hot cereals, desserts, and other infant foods, and 57 g/kg in dry snacks; in non-alcoholic beverages (sports and “energy” drinks, flavored waters, soft drinks, fruit juices and drinks, vegetable juices, milk, dairy analogs, meal replacements, and protein drinks) at maximum levels ranging from 0.8-6 g/L; in oral nutritional supplements and enteral tube feeding products at 20 g/L; in coffee and tea at levels from 5-10 g/L; in chewing gum and sugar substitutes at 300 g/kg; in beverage whiteners at 600 g/kg; and in the following foods, at maximum levels ranging from 4.8-80 g/kg in baked goods and baking mixes; breakfast cereals; dairy product analogs (cream substitutes, frozen desserts, yogurt-type foods); frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; meal-replacement and snack bars; jams and jellies; yogurt; canned fruits and fruit-based desserts; and syrups.
Basis: Scientific procedures
Notifier: Kyowa Hakko Bio Co., Ltd.
Notifier Address: 1-9-2, Otemachi, Choyoda-ku
Tokyo, 100-0004
Japan
FDA's Letter: Pending

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