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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 815

2'-fucosyllactose and difucosyllactose

Intended Use: For use as an ingredient in non-exempt infant formulas for term infants at a maximum level of 1.6 grams per liter (g/L); in toddler formula and in other drinks for young children (between 1 and 3 years of age) at 1.2 g/L; in other foods for infants and young children at 10 grams per kilogram (g/kg); and, in beverages and beverage bases, grain products and pastas, milk (whole and skim), and milk products that are conventional food products used by the general population, at levels ranging from 2 to 40 g/kg.
Basis: Scientific procedures
Notifier: Glycom A/S
Notifier Address: Kogle Allé 4
Hørsholm, Denmark
GRAS Notice (releasable information): GRN 815 (in PDF) (3.3 MB)
Date of closure: Aug 20, 2019
FDA's Letter: FDA has no questions (in PDF) (183 KB)
Additional correspondence: May 7, 2020
Correction Letter (in PDF) (57 kB)
Additional correspondence 2: May 7, 2020
Corrected response letter (in PDF) (620 kB)
Additional correspondence 3: Sep 11, 2020
Correction letter (in PDF) (322 kB)
Additional correspondence 4: Sep 11, 2020
Corrected response letter (in PDF) (657 kB)

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