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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 636

Phosphatidylserine derived from sunflower lecithin

Intended Use: Nutrient and as an alternative to other sunflower PS sources at levels up to 100 milligrams (mg) per serving in dairy product analogs (imitation milk and soy milk), grain products (nutritional bars: breakfast, granola, and protein), milk products (flavored milk and milk drinks, excluding fluid milk, milk-based meal replacements, and yogurt), and processed fruits and fruit juices (fruit flavored drinks); at levels of 50 mg per serving in breakfast cereals and milk (fluid: regular, filled, buttermilk, and dry reconstituted); and at levels up to 300 mg per day in medical foods.  
Basis: Scientific procedures
Notifier: ECA Healthcare, Inc.
Notifier Address: 1017 North Building, 1839 Qixin Rd, Shanghai, 201101, China
Date of filing: Mar 29, 2016
GRAS Notice (releasable information): GRN 636 (in PDF) (1.7 MB)
Date of closure: Jul 1, 2016
FDA's Letter: At the notifier's request, FDA ceased to evaluate this notice
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