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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1157

2'-fucosyllactose

Intended Use: Intended for use as an ingredient in milk- and soy-based, non-exempt infant formula for term infants at up to 2.4 g/L of formula as consumed; in formula intended for young children (> 12 months 3 years) and meal replacement drinks for young children ages 1 3 years at up to 2.4 g/L, as consumed; in foods intended for infants and young children: up to 10.0 g/L in yogurt and juice drinks, 10.9 g/kg in cereals and desserts, and 57 g/kg in dry snacks; in sports and "energy" drinks, flavored water, fruit juices and drinks, milk drinks, dairy alternatives, milk-based meal replacements, and nutritional drinks for pregnant women at maximum levels in the range of 0.8-6 g/L; and in the following food categories at maximum levels in the range of 4.8-80 g/kg: breakfast cereals; frozen dairy desserts; puddings, custards, mousses, and fruit fillings; yogurt; meal replacement and snack bars; syrups; and jams, jellies, fruit preserves, and fruit butters.
Basis: Scientific procedures
Notifier: Synaura Biotechnology (Shanghai) Co., Ltd.
Notifier Address: Floor l-2, Building 2, Lane 500
Furong Hua Road, Pudong New Area
Shanghai
China
FDA's Letter: Pending
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