GRAS Notices

GRN No. 1053

Intended Use:	Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 0.40 g/L of formula as consumed; in toddler formulas at a level of 0.50 g/L, as consumed; in infant and toddler drinks at 2.1 g/L and in hot cereals, desserts, dry snacks and other infant and toddler foods at 2.3 12 g/kg; in non-alcoholic beverages (sports and energy drinks, flavored waters, soft drinks, coffee and tea, fruit juices and drinks, vegetable juices, milk, milk substitutes, meal replacements, and protein drinks) at 0.25 12.5 g/L; in oral nutritional and enteral tube feeding products at 4.1 g/L; in chewing gum and sugar substitutes at 62 g/kg; in beverage whiteners and cream substitutes at 125 g/kg; and in baked goods and baking mixes; breakfast cereals; frozen dairy desserts; fruit and water ices; gelatins, puddings, and fillings; cereal and granola bars (including meal-replacement bars); jams and jellies; yogurt (including non-dairy yogurt); canned fruits; fruit-based desserts; and syrups at 1.0 17.0 g/kg.
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 1053 with Amendments (in PDF) (15.4 MB)
Date of closure:	May 12, 2023
FDA's Letter:	FDA Has No Questions (in PDF) (266 kB)