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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 735

2'-Fucosyllactose

Intended Use: Ingredient in milk-and soy-based, non-exempt infant formulas for term infants and in toddler formulas at a maximum level of 2.4 g/L of formula as consumed; infant and toddler foods at levels of 0.24-1.2 g/serving; and in the following food categories at levels of 0.28-1.2 g/serving: beverages and beverage bases; breakfast cereals; dairy product analogs; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain products and pastas; jams and jellies; milk and milk products; processed fruits and fruit juices; and sweet sauces, toppings, and syrups.
Basis: Scientific procedures
Notifier: Glycosyn, LLC and Friesland Campina Domo B.V.
Notifier Address: 890 Winter Street
Suite 208
Waltham, MA 02451
GRAS Notice (releasable information): GRN 735 part 1 (in PDF) (15 MB)
  Part 2: GRN 735 part 2 (in PDF) (14 MB)
  Part 3: GRN 735 part 3 (in PDF) (10 MB)
  Part 4: GRN 735 part 4 (in PDF) (15 MB)
  Part 5: GRN 735 part 5 (in PDF) (11.8 MB)
Date of closure: Apr 6, 2018
FDA's Letter: FDA has no questions (in PDF) (103 kB)
Additional correspondence: Apr 30, 2020
Supplemental Letter (in PDF) (176 kB)
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