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. 1301

Algal oil (≥45% docosahexaenoic acid from Schizochytrium sp. “JDW-108”)

Intended Use: Intended for use as an ingredient in the food categories listed in 21 CFR 184.1472(a)(3) (Menhaden oil) at use levels that are no more than 22.22% of the levels specified for menhaden oil in that regulation (excluding use in products under the jurisdiction of the United States Department of Agriculture(USDA)). NovoSana states that algal oil (≥45% DHA) will be used as the sole source of DHA in any given food category, and if algal oil (≥45% DHA) is blended with a source of 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. NovoSana also intends to use algal oil (≥45% DHA) as an ingredient in non-exempt infant formula for term infants and exempt infant formula for preterm 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 DHA to ARA.
Basis: Scientific procedures
Notifier: NovoSana (Taicang) Co., Ltd.
Notifier Address: No. 9 Changzhou Road, Taicang Economic Development Zone, Taicang, Suzhou
Jiangsu Province 215400
CHINA
FDA's Letter: Pending
-
-