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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 438

Substance: Plant stanol esters
Intended Use: As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals; cheeses, coffee and tea, dairy product analogs, fats and oils, grain products and pastas, gravies and sauces, milk, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, soft candy, and soups and soup mixes at a level ranging between 0.5 to 2.0 grams plant stanols per serving (provided as plant stanol esters). Use in gravies, sauces, soup and soup mixes under USDA's jurisdiction is excluded.
Basis: Scientific procedures
Notifier: Raiso Nutrition Ltd., Benecol Division
P.O. Box 101 (Raisiokaari 55)
Date of filing: Aug 1, 2012
GRAS Notice (releasable information): 438
Date of closure / FDA's Letter: Jan 16, 2013
FDA has no questions