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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1008

Algal oil (≥45% docosahexaenoic acid) from Aurantiochytrium limacinum TKD-1

Intended Use: For use as an ingredient in the same food categories as those listed in 21 CFR 184.1472(a)(3) (Menhaden oil) at use levels that are no more than 18% of the levels specified for menhaden oil in that regulation. ATK Biotech states that if algal oil (≥45% DHA) is blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be no more than 1.5 g of DHA/person (p)/d and no more than 3.0 g/p/d of DHA and EPA combined. Algal oil (≥45% DHA) also will be used 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% (w/w) of total fat as DHA in combination with a safe and suitable source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 of DHA to ARA.
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 1008 with amendments (in PDF) (2.1 MB)
Date of closure: Feb 25, 2022
FDA's Letter: FDA has no questions (in PDF) (166 kB)

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