GRN No. 1099

3-fucosyllactose

• Intended Use: Intended for use as an ingredient in cow milk-, soy-, and partially hydrolyzed protein-based, non-exempt infant formulas for term infants up to 0.9 g/L of formula (as consumed); formula intended for young children aged 1 to 3 years up to 1.2 g/L of formula (as consumed); other drinks and foods for infants and young children under 3 years of age that include yogurt and juice beverages up to 0.44 g/kg and hot cereals, crackers, pretzels, cookies, and snack items up to 4.4 g/kg; cereal, granola, energy, protein, and meal replacement bars; enhanced and fortified waters; sports, isotonic and energy drinks; breakfast cereals; fermented milk, flavored milk and mixes; smoothies, yogurts, meal replacement beverages (milk- and non-milk based), and milk substitutes; fruit juices and nectars; fruit-flavored beverages and vegetable juices; and gummy candies at maximum levels ranging from 0.26 to 8.8 g/kg; and in oral and enteral tube feeding formulas (11 years and older) up to 6.6 g/L (as consumed).
• Basis: Scientific procedures
• Notifier: Chr. Hansen A/S
• Notifier Address: Boege Allé 10-12; 2970 Hoersholm; Denmark
• GRAS Notice (releasable information): GRN 1099 with amendments (in PDF) (2.6 MB)
• Date of closure: Aug 29, 2023
• FDA's Letter: FDA has no questions (in PDF) (292 kB)