Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

GRAS Notices
  • Print
  • Share
  • E-mail
-

GRN No. 1217

Algal oil (≥40% docosahexaenoic acid) from Aurantiochytrium limacinum CCAP A1

Intended Use: Intended for use as an ingredient in the 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 (≥40% DHA) is blended with another source of DHA or eicosapentaenoic acid (EPA), the total dietary exposure 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. HuveNutra also intends to use algal oil (≥40% DHA) as an ingredient in 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 source of arachidonic acid (ARA) at a ratio ranging from 1:1 to 1:2 DHA to ARA.
Basis: Scientific procedures
Notifier: Huve Nutraceuticals Ltd
Notifier Address: 3a Nikaly Haytov Street
5th Floor, Sofia 1113
Bulgaria
FDA's Letter: Pending
-
-