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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 933

Algal oil (≥36% docosahexaenoic acid) from Schizochytrium sp. strain DHF

Intended Use: Intended for use as an ingredient in the same food categories as those currently listed in 21 CFR 184.1472(a)(3) (Menhaden oil),1 at use levels of algal oil (≥36% DHA) that are no more than 27.78% of the levels specified for menhaden oil in that regulation. Hubei Fuxing also intends to use algal oil (≥36% DHA) as an ingredient in exempt and non-exempt, soy-, whey-, cow’s milk-, amino acid-, and extensively hydrolyzed protein-based infant formula for pre-term, low birth weight, and term infants at a maximum level of 0.5% 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: Hubei Fuxing BioTechnology, Co., Ltd.
Notifier Address: Floor 11th, Bldg. 23
Yinhu Enterprise Zone, Baishazhou Ave
Hongshan District, Hubei Province
GRAS Notice (releasable information): GRM 933 (in PDF) (3.6 MB)
FDA's Letter: Pending