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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1053

6'-sialyllactose sodium salt

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 0.50 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 supplements 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
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)