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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1185

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)1 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) is also intended for use as an ingredient in cow milk-, goat milk-, soy-, amino acid-, and extensively hydrolyzed protein-based, non-exempt infant
Basis: Scientific procedures
Notifier: Runke Bioengineering (Fujian) Co., Ltd.
Notifier Address: West of No. 552 Rd., Jindu Industrial Clusters Zone, Zhao'an
Zhangzhou, Fujian Province, 363500
China
GRAS Notice (releasable information): GRN 1185 (in PDF) (8.4 MB)
FDA's Letter: Pending
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