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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1162

Fungal oil (≥38% arachidonic acid (ARA)) from Mortierella alpina FJRK-MA01

Intended Use: Intended for use as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt infant formula for pre-term and low birthweight infants, at a level of 0.75% and 0.50% (w/w) of total fatty acids for term and pre-term or low-birthweight infants, respectively, and in combination with a safe and suitable source of docosahexaenoic acid (DHA) at a ratio ranging from 2:1 to 1:1 of ARA to DHA.
Basis: Scientific procedures
Notifier: Runke Bioengineering (Fujian) Co., Ltd.
Notifier Address: West of No. 552 Rd.
Jindu Industrial Clusters Zone, Zhaoan, Zhangzhou
Fujian Province 363500
GRAS Notice (releasable information): GRN 1162 (in PDF) (13.5 MB)
Date of closure: Feb 8, 2024
FDA's Letter: At the notifier's request, FDA ceased to evaluate this notice (in PDF) (236 kB)