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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1236

Algal oil (≥40% docosahexaenoic acid) from Aurantiochytrium limacinum H Sc-01

Intended Use: Intended 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 25% of the levels specified for menhaden oil in that regulation. Shaanxi states that if algal oil (≥40% DHA) is blended with another source of DHA or eicosapentaenoic acid (EPA), the use levels will result in dietary exposure that is 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 (≥40% DHA) is also intended for use as an ingredient in milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt infant formula for pre-term infants, 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: Shaanxi Healthful Bioengineering Co., Ltd.
Notifier Address: C1-C5 Building, Torch Industrial Park
Yangling Demonstration Zone, Shaanxi Province
CHINA
GRAS Notice (releasable information): GRN 1236 with amendments (in PDF) (9.5 MB)
Date of closure: Jun 10, 2025
FDA's Letter: FDA has no questions (240 kB)
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