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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 650

2'-O-fucosyllactose

Intended Use: For use in term infant formula at a maximum level of 2,400 milligrams (mg)/Liter. Also intended for use in baby foods and drinks for young children, beverages and beverages bases, dairy product analogs, grain products and pastas, milk (whole and skim), milk products, processed fruits and juices, and processed vegetables and juices at maximum levels ranging from 0.084 to 2.04 grams/serving
Basis: Scientific procedures
Notifier: Glycom A/S
Notifier Address: Diplomvej 373, DK-2800 Kongens. Lyngby, Denmark
Date of filing: May 26, 2016
GRAS Notice (releasable information): GRN 650 (in PDF) (5.9 MB)
Date of closure: Nov 23, 2016
FDA's Letter: FDA has no questions
Additional correspondence: Sep 9, 2020
Supplemental Letter (in PDF) (530 kB)
Additional correspondence: Sep 11, 2020
Supplemental Letter (in PDF) (532 kB)
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