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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 546

2'-O-fucosyllactose

Intended Use: Intended for use in term infant formula at a maximum level of 2,400 milligrams (mg)/Liter. Also intended for use in baked goods and baking mixes, beverages and beverages bases, coffee and tea, dairy product analogs, infant and toddler foods, grain products and pastas, milk (whole and skim), processed fruits and juices, processed vegetables and juices, and sugar substitutes at maximum levels ranging from 0.084 to 2.4 grams/serving.
Basis: Scientific Procedures
Notifier: Glycom A/S
Notifier Address: Diplomvej 373DK-2800 Kgs. LyngbyDenmark
Date of filing: Oct 10, 2014
GRAS Notice (releasable information): GRN 546 (in PDF) (1.1 MB)
Date of closure: Sep 16, 2015
Date of FDA’s corrected letter: Sep 24, 2014
FDA's Letter: FDA has no questions
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