GRAS Notices
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GRN No. 815
2'-fucosyllactose and difucosyllactose
| Intended Use: | For use as an ingredient in non-exempt infant formulas for term infants at a maximum level of 1.6 grams per liter (g/L); in toddler formula and in other drinks for young children (between 1 and 3 years of age) at 1.2 g/L; in other foods for infants and young children at 10 grams per kilogram (g/kg); and, in beverages and beverage bases, grain products and pastas, milk (whole and skim), and milk products that are conventional food products used by the general population, at levels ranging from 2 to 40 g/kg. |
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| Basis: | Scientific procedures |
| Notifier: | Glycom A/S |
| Notifier Address: |
Kogle Allé 4 Hørsholm, Denmark |
| GRAS Notice (releasable information): | GRN 815 (in PDF) (3.3 MB) |
| Date of closure: | Aug 20, 2019 |
| Date of FDA’s corrected letter: | Sep 11, 2020 |
| FDA's Letter: | FDA has no questions (in PDF) (250 kB) |
| Additional correspondence: | May 7, 2020 |
| Correction Letter (in PDF) (193 kB) | |
| Additional correspondence: | Sep 11, 2020 |
| Correction letter (in PDF) (132 kB) |
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