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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: For use as an ingredient in the same food categories as those currently listed in 21 CFR 184.1472(a)(3) (Menhaden oil),* 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, and as the sole added source of DHA in any given food category, and if blended with another source of DHA or eicosapentaenoic acid (EPA), the total dietary exposure to DHA will be no more than 1.5 g/person (p)/day (d) and no more than 3.0 g/p/d of DHA and EPA combined. Hubei Fuxing also intends to use algal oil (≥36% DHA) as an ingredient in cow milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, exempt and non-exempt 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.

* Hubei Fuxing states that algal oil (≥36% DHA) is not intended for use in products under the U.S. Department of Agricultures jurisdiction or in products defined in 21 CFR 170.3(n)(13).
Basis: Scientific procedures
Notifier: Hubei Fuxing BioTechnology, Co., Ltd.
Notifier Address: Floor 11th, Bldg. 23
Yinhu Enterprise Zone, Baishazhou Ave
Hongshan District, Hubei Province
CHINA
GRAS Notice (releasable information): GRM 933 with amendments (in PDF) (5.1 MB)
Date of closure: Nov 13, 2020
FDA's Letter: FDA has no questions (in PDF) (757 kB)

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