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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1035

Lacto-N-fucopentaose I with 2'-fucosyllactose

Intended Use: Intended for use as an ingredient in non-exempt infant formula for term infants at use levels providing up to 0.8 g LNFP-I/L infant formula as consumed. LNFP-I/2'-FL is also intended for use as an ingredient in other foods at use levels providing LNFP-I up to the maximum levels specified.
Basis: Scientific procedures
Notifier: Glycom A/S
Notifier Address: Kogle Allé 4
2970 Hørsholm
GRAS Notice (releasable information): GRN 1035 with amendments (in PDF) (14.9 MB)
Date of closure: Jan 19, 2023
Date of FDA’s corrected letter: Mar 1, 2023
FDA's Letter: FDA has no questions (in PDF) (288 kB)
Additional correspondence: Mar 1, 2023
Correction Letter (in PDF) (138 kB)