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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1313

Algal oil (≥35% docosahexaenoic acid) from Schizochytrium limacinum CCAP A2

Intended Use: Intended for use as an ingredient in the same food categories listed in 21 CFR 184.1472(a)(3) (Menhaden oil) at levels up to 20% of the levels specified for menhaden oil in that regulation. HuveNutra states that if algal oil (≥35% DHA) is blended with another source of DHA or eicosapentaenoic acid (EPA), the total dietary exposure will be no more than 1.5 g DHA/person (p)/d and no more than 3.0 g/p/d of DHA and EPA combined. HuveNutra also intends to use algal oil (≥35% DHA) as an ingredient in cow milk-, goat milk-, and soy-based, non-exempt infant formula for term infants and in exempt infant formula for pre-term 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 2:1 ARA to DHA. HuveNutra also states that algal oil (≥35% DHA) is not intended for use in products under the U.S. Department of Agricultures jurisdiction.
Basis: Scientific procedures
Notifier: Huve Nutraceuticals Ltd
Notifier Address: 3a Nikaly Haytov Street
5th Floor, Sofia 1113
BULGARIA
GRAS Notice (releasable information): GRN 1313 (in PDF) (1.9 MB)
FDA's Letter: Pending
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