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