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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1169

6'-sialyllactose sodium salt

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 0.34 g/L of formula as consumed; in formula intended for young children (ages 1-3 years) at a level of 0.34 g/L as consumed; in yogurt and juice drinks for infants and young children at 1.8 g/L and in hot cereals, desserts, dry snacks, and other foods intended for infants and young children at 1.96 10.25 g/kg; in non-alcoholic beverages (sports, isotonic, and energy drinks; enhanced or fortified waters; soft drinks; coffee and tea; fruit nectars, juices, and drinks; vegetable nectars and juices; milk, flavored milk drinks, buttermilk, evaporated and condensed milk, and milk substitutes; meal replacements; nutritional drinks for pregnant women; and protein drinks) and in oral nutritional drinks and enteral tube feeding products (for ages 11 years and older); at levels up to 10.68 g/L; and in the following food categories for use at levels up to 106.77 g/kg: baked goods and baking mixes; hot cereals; ready-to-eat breakfast cereals; frozen dairy desserts; fruit and water ices; puddings and fillings; cereal and granola bars; protein and meal-replacement bars; jams, jellies, preserves, and fruit butters; yogurt (including non-dairy yogurt); canned fruits; fruit-based desserts; and syrups (for flavoring milk beverages); chewing gum and sugar substitutes; and beverage whiteners and cream substitutes.
Basis: Scientific procedures
Notifier: GeneChem, Inc.
Notifier Address: Migun Techno World II, A-201
187 Techno 2-ro, Yuseong-gu
34025, Daejeon
Republic of Korea
GRAS Notice (releasable information): GRN 1169 (in PDF) (14.7 MB)
  Part 2: GRN 1169 Appendices - part 1 (in PDF) (15.7 MB)
  Part 3: GRN 1169 Appendices - part 2 (in PDF) (12.3 MB)
  Part 4: GRN 1169 Appendices - part 3 (in PDF) (12.3 MB)
Date of closure: Oct 7, 2024
FDA's Letter: At the notifier's request, FDA ceased to evaluate this notice (in PDF) (235 kB)
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