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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 862

Algal oil (40% docosahexaenoic acid) from Schizochytrium sp. strain ONC-T18

Intended Use: Algal oil is intended for use in milk- and soy-based non-exempt infant formula for term infants and milk- and soy-based exempt infant formula for pre-term infants at levels up to 0.5% (w/w) of total fat as DHA with the provision that algal oil will be used in infant formula 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. The oil formulation is intended for use in the food categories listed in 21 CFR 184.1472(a)(3) at up to 25% of the levels specified and the powder formulation is intended for use in the food categories listed in 21 CFR 184.1472(a)(3), excluding those products under USDA jurisdiction, at up to 100% of the levels specified; and, with the provision that if algal oil 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)/day (d) and no more than 3.0 g/p/d of DHA and EPA combined.
Basis: Scientific procedures
Notifier: BASF Corporation
Notifier Address: 100 Park Avenue
Florham Park, NJ 07932
GRAS Notice (releasable information): GRN 862 with amendments (in PDF) (18.2 MB)
Date of closure: Jun 15, 2020
FDA's Letter: FDA has no questions (in PDF) (748 kB)

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