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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 and formulas for young children (>12 months) at a level of 0.24 g/L, as consumed; in drinks for infants and young children at 0.15-1.0 g/L; in hot cereals, desserts, dry snacks, and other foods for infants and young children at 1.1-5.7 g/kg; in non-alcoholic beverages (sports and "energy drinks", fortified and flavored waters, soft drinks, coffee and tea, fruit juices and nectars, fruit-flavored drinks, vegetable juices and nectars, milk, flavored milk, buttermilk, milk substitutes, meal replacements, and protein drinks) at 0.126.0 g/L; in oral nutritional supplements and enteral tube feeding products (≥11 years and older) at 2.0 g/L; in chewing gum at 30 g/kg; in table-top sweeteners at 30 g/kg; in beverage whiteners and cream substitutes at 60 g/kg; and in breads and baked goods; 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); evaporated and condensed milk; canned fruits; fruit-based desserts; and syrups at 0.12-8.0 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 with amendments (in PDF) (12.6 MB)
Date of closure: Apr 18, 2023
FDA's Letter: FDA has no questions (in PDF) (292 kB)