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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1115

Fungal oil (≥40% arachidonic acid (ARA)) from Mortierella alpina strain AF

Intended Use: Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants at levels providing up to 0.75% of fat as ARA and in exempt infant formula for pre-term infants at levels providing up to 0.4% of fat as ARA. Hubei Fuxing states that M. alpina oil will be used in combination with a safe and suitable source of docosahexaenoic acid (DHA) at a ratio ranging from 1:1 to 2:1 ARA:DHA.
Basis: Scientific procedures
Notifier: Hubei Fuxing Biotechnology Co., Ltd.
Notifier Address: No. 18 Fuxing Ave
Chenhu Town, Hanchuan City 431608, Hubei Province
China
GRAS Notice (releasable information): GRN 1115 with amendments (in PDF) (13.1 MB)
Date of closure: Sep 18, 2023
FDA's Letter: FDA has no questions (in PDF) (256 kB)
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