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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 934

Algal oil (≥35% docosahexanoic acid (DHA)) derived from Schizochytrium sp. strain CABIO-A-2

Intended Use: Intended for use as an ingredient, at up to 5.8 % (w/w) in food categories as listed in 21 CFR 184.1472(a)(3), and at up to 0.5% (w/w) of fatty acids as DHA in non-exempt infant formula for term infants. and for use as an ingredient in cow milk- and soy-based, 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 ARA at a ratio ranging from 1:1 to 1:2 DHA:ARA.
Basis: Scientific procedures
Notifier: CABIO Biotech (Wuhan) Co., Ltd.
Notifier Address: Wuhan Pharmacy Park, Jiangxia Avenue
Jiangxia Economic Development Zone Wuhan, Wuhan
CHINA
GRAS Notice (releasable information): GRN 934 (in PDF) (2.0 MB)
Date of closure: Jul 20, 2021
FDA's Letter: FDA has no questions (in PDF) (214 kB)
Additional correspondence: Aug 8, 2025
Supplemental Letter (in PDF) (219 kB)
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