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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 776

Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. strain FCC-1324

Intended Use: Ingredient in non-exempt and exempt infant formulas for term and pre-term infants at use levels up to 0.5% (wt/wt) of fatty acids as DHA 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.
Basis: Scientific procedures
Notifier: Fermentalg
Notifier Address: 4 Rue Riviere
33500 Libourne
GRAS Notice (releasable information): GRN 776 part 1 (in PDF) (2 MB)
  Part 2: GRN 776 part 2 (in PDF) (1.6 MB)
Date of closure: Oct 26, 2018
FDA's Letter: FDA has no questions (in PDF) (573 kB)