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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 963

Fungal oil (≥40% arachidonic acid) from Mortierella alpina

Intended Use: Intended for use as an ingredient in cow milk-and soy-based non-exempt infant formulas for term infants at levels providing up to 0.75% of fat as arachidonic acid (ARA) and in exempt infant formula for pre-term infants at levels providing up to 0.4% of fat as ARA, in combination with a safe and suitable source of docosahexaenoic acid (DHA) at a ratio ranging from 1:1 to 2:1 ARA:DHA.
Basis: Scientific procedures
Notifier: BASF Corporation
Notifier Address: 100 Park Avenue
Florham Park, NJ 07932
GRAS Notice (releasable information): GRN 963 (in PDF) (17.3 MB)
  Part 2: GRN 963 amendments (1.2 MB)
Date of closure: Oct 19, 2021
FDA's Letter: FDA has no questions (in PDF) (429 kB)