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
• 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)