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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 881

6'-sialyllactose sodium salt

Intended Use: Ingredient at levels up to 0.4 g/L in non-exempt infant formula for term infants; 1 0.3 g/L in beverages and formula for young children (>12 months of age); 2.5 g/kg in foods for infants and young children; 5 g/kg in yogurt; 0.5 g/L in buttermilk and fluid milk (flavored and unflavored); 1 g/L in meal replacement drinks; 10 g/kg in meal replacement bars; 5 g/kg in cereal and granola bars; and 0.5 g/L in soft drinks, fruit-based drinks, sports drinks, energy drinks, and enhanced waters.
Basis: Scientific procedures
Notifier: Glycom A/S
Notifier Address: 2970 Kogle Allé 4
Hørsholm, Denmark
GRAS Notice (releasable information): GRN 881 with amendments (in PDF) (4.6 MB)
Date of closure: Feb 24, 2020
Date of FDA’s corrected letter: Apr 13, 2020
FDA's Letter: FDA has no questions (in PDF) (562 kB)