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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1052

3'-sialyllactose sodium salt

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 0.24 g/L of formula as consumed; in toddler formulas1 at a level of 0.24 g/L, as consumed; in infant and toddler drinks at 0.15 – 1.0 g/L and in hot cereals, desserts, dry snacks and other infant and toddler foods at 1.1 – 5.7 g/kg; in non-alcoholic beverages (sports and “energy” drinks, flavored waters, soft drinks, fruit juices and drinks, vegetable juices, milk, milk substitutes, meal replacements, and protein drinks at 0.12 – 6.0 g/L; in oral nutritional supplements and enteral tube feeding products at 2.0 g/L; in coffee and tea at 1.0 g/L; in chewing gum and sugar substitutes at 30 g/kg; in beverage whiteners and cream substitutes at 60 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 and fruit-based desserts; and syrups at 0.48 – 8.0 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 1052 in PDF (14 MB)
FDA's Letter: Pending