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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1037

3-fucosyllactose

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants at a level up to 0.75 g/L as consumed; formula and drinks for young children (>12 months) at levels up to 0.90 g/L as consumed; foods for infants and young children at levels up to 6.25 g/kg; and in the following foods at maximum levels ranging from 1.25 to 25 g/kg: meal replacement and nutritional beverages; “sports”, “isotonic”, and “energy” drinks, soft drinks, and “enhanced” or “fortified” water; meal replacement bars; cereal and nutrition bars; unflavored and flavored milk; buttermilk; yogurt drinks and beverages containing live microorganisms; yogurt; and fruit drinks and ades.
Basis: Scientific procedures
Notifier: Glycom A/S
Notifier Address: Kogle Allé 4
2970 Hørsholm
Denmark
GRAS Notice (releasable information): GRN 1037 with amendments (in PDF) (7 MB)
Date of closure: Nov 7, 2022
FDA's Letter: FDA has no questions (in PDF) (287 kB)
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