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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 659

Lacto-N-neotetraose

Intended Use: Ingredient in nonexempt infant formulas for term infants at a maximum use level of 600 milligrams (mg)/liter (L) and in beverages and beverage bases, dairy product analogs, milk (whole and skim), milk products, processed fruits and juices, grain products and pastas, infant foods, and toddler foods (including follow-on formulas) at use levels ranging from 0.02 to 3 grams (g)/serving.
Basis: Scientific procedures
Notifier: Glycom A/S
Notifier Address: Diplomvej 373, DK-2800 Kgs. Lyngby, Denmark
Date of filing: Aug 10, 2016
GRAS Notice (releasable information): GRN 659 with supplements (in PDF) (3.3 MB)
Date of closure: Nov 23, 2016
FDA's Letter: FDA has no questions
Additional correspondence: Dec 22, 2021
Supplemental Letter (in PDF) (267 kB)
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