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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 1156

Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. FJRK-SCH3

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 28.57% of the levels specified for menhaden oil in that regulation. Runke states that if algal oil (≥35% DHA) is blended with another source of DHA or eicosapentaenoic acid (EPA), the levels will be 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 (≥35% DHA) also will be used as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant formula for term infants and exempt infant formula for pre-term and low birthweight 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: Runke Bioengineering (Fujian) Co., Ltd.
Notifier Address: West of No. 552 Rd.
Jindu Industrial Clusters Zone, Zhaoan, Zhangzhou
Fujian Province 363500
GRAS Notice (releasable information): GRN 1156 (in PDF) (7.9 MB)
Date of closure: Feb 8, 2024
FDA's Letter: At the notifier's request, FDA ceased to evaluate this notice (in PDF) (204 kB)