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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 542

Substance: Lutein
Intended Use: Intended for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, infant and toddler foods (other than infant formula), milk products, processed fruits and fruit juices, soft candy, hard candy, and soups and soup mixes at use levels of 0.3 to 3 mg lutein equivalent/serving.
Basis: Scientific Procedures
Notifier: INNOBIO Limited
No. 49, DDA, Dalian, Liaoning 116600, China
Date of filing: Sep 29, 2014
GRAS Notice (releasable information): GRN 542 (in PDF) (2.8 MB)
Date of closure: Mar 16, 2015
FDA's Letter: FDA has no questions; some uses may require a color additive listing

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