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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1259

Fungal oil (≥40% arachidonic acid (ARA)) from Mortierella alpina strain TKA-1

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 fatty acids as ARA and in exempt infant formula for pre-term infants at levels providing up to 0.40% of fatty acids as ARA. ATK Biotech 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: ATK Biotech Co., Ltd.
Notifier Address: 109 Husong Road, Shitan Industrial Park
Shizi Town, Quanjiao County, Chuzhou City
CHINA
GRAS Notice (releasable information): GRN 1259 (in PDF) (7.4 MB)
FDA's Letter: Pending
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