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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1600

Pure Bioscience, Inc.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: A solution of silver dihydrogen citrate stabilized with sodium lauryl sulfate and citric acid.
Notifier: Pure Bioscience, Inc.
Manufacturer/Supplier: Pure Bioscience, Inc.
Intended Use: As an antimicrobial solution applied by spray or dip on fruits and vegetables intended for processing (see Limitations/Specifications).
Limitations/Specifications: For use at levels up to 30 ppm silver dihydrogen citrate in the spray or dip applied to fruits and vegetables intended for processing. The FCS is not intended for use on any citrus fruit nor is it for use on grapes intended for winemaking. The FCS is not for use in combination with any other silver containing antimicrobial.
Effective Date: Jan 7, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 613 kb)
FDA Decision: Finding of No Significant Impact (FONSI)

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