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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 860

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

Intended Use: 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 27.775% 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-, cows milk-, amino acid-, and hydrolyzed protein-based infant formula for pre-term 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
Notifier Address: Floor 11th, Bldg.23, Yinhu Enterprise Zone, Baishazhou Ave.
Hongshan District, Hubei Province
GRAS Notice (releasable information): GRN 860 (in PDF) (8.6 MB)
Date of closure: Sep 3, 2019
FDA's Letter: At the notifier's request, FDA ceased to evaluate this notice (in PDF) (59 KB)