GRAS Notices
-
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, 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; enhanced or fortified waters; soft drinks; fruit juices, nectars and drinks; vegetable juices and nectars; milk; buttermilk; dairy analogs; meal replacements; and nutritional drinks for pregnant women) at maximum levels ranging from 1.2-12 g/L; in oral nutritional supplements and enteral tube feeding products at 20 g/L; in coffee and tea at 10 g/L; in sugar substitutes at 300 g/kg; in powdered beverage whiteners at 600 g/kg; in liquid beverage whiteners at 80 g/L; and in the following foods, at maximum levels ranging from 7-80 g/kg in gluten free breads and baked goods; breakfast cereals; frozen dairy desserts; puddings, custards, and mousses; fruit fillings; meal-replacement and snack bars; jams, jellies, preserves, and fruit butters; yogurt; and syrups used to flavor milk beverages. |
|---|---|
| Basis: | Scientific procedures |
| Notifier: | Kyowa Hakko Bio Co., Ltd. |
| Notifier Address: |
1-9-2, Otemachi, Choyoda-ku Tokyo, 100-0004 Japan |
| GRAS Notice (releasable information): | GRN 1051 (in PDF) (18 MB) |
| Part 2: | GRN 1051 part 2 amendments (in PDF) (4.9MB) |
| Date of closure: | Nov 21, 2023 |
| FDA's Letter: | FDA has no questions (in PDF) (298 kB) |
-
