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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 591

Streptococcus salivarius K12

Intended Use: For use as an ingredient in baby, infant, and toddler food (excluding infant formula), baked goods and baking mixes, beverage and beverage bases, breakfast cereals, cheeses, chewing gum, dairy product analogs, frozen dairy desserts and mixes, gelatins, puddings and fillings, grain products and pastas, hard candy, milk, whole and skim; milk products, nuts and nut products, processed fruits and fruit juices, soft candy, sweet sauces, toppings and syrups, and medical foods, at levels up to 20 milligrams per serving (providing a minimum of 2x109 colony forming units (CFU) per serving).
Basis: Scientific procedures
Notifier: BLIS Technologies Ltd.
Notifier Address: 10 Birch Street, P.O. Box 5804, Dunedin, New Zealand
Date of filing: Aug 5, 2015
GRAS Notice (releasable information): GRN 591 (in PDF) (2.9 MB)
Date of closure: Jan 25, 2016
Date of FDA’s corrected letter: Jun 5, 2019
FDA's Letter: FDA has no questions (in PDF) (340 kB)
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