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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1008

Algal oil (≥35% docosahexaenoic acid) from Aurantiochytrium limacinum TKD-1

Intended Use: Intended for use as an ingredient in cow milk- and soy-based, non-exempt and exempt infant formula for term and pre-term infants, respectively, at a maximum level of 0.5% of total fat as DHA in combination with a safe and suitable source of arachidonic acid, and as an ingredient in the same food categories as those currently listed in 21 CFR 184.1472(a)(3) (Menhaden oil) at use levels that are no more than 29% of the levels specified for menhaden oil in that regulation.
Basis: Scientific procedures
Notifier: ATK Biotech Co., Ltd.
Notifier Address: 109 Husong Road
Shitan Industrial Park
Shizi Town, Quanjiao County
Chuzhou City
FDA's Letter: Pending