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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 833

Lacto-N-tetraose

Intended Use: Ingredient at levels up to 0.8 g/L in non-exempt, cows milk-based infant formula for term infants; 0.6 g/L in drinks for young children (including toddler formulas); 5 g/kg in foods for infants and young children (including toddler foods); 10 g/kg in yogurt; 1 g/L in fluid milk (flavored and unflavored); 2 g/L in meal replacement drinks; 20 g/kg in meal replacement bars; 10 g/kg in cereal and granola bars; and 1 g/L in soft drinks, fruit-based -ades, sports drinks, energy drinks, and enhanced waters.
Basis: Scientific procedures
Notifier: Glycom A/S
Notifier Address: Kogle Allé 4
2970 Hørsholm
Denmark
GRAS Notice (releasable information): GRN 833 with amendments (in PDF) (11 MB)
Date of closure: Oct 7, 2019
Date of FDA’s corrected letter: Apr 13, 2020
FDA's Letter: FDA has no questions (in PDF) (702 kB)
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