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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. 1470

KAY Chemical Company, a Division of Ecolab, 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: Hypochlorous acid (CAS Reg. No. 7790-92-3) electrolytically generated in dilute solution.
REPLACES FCN 692
Notifier: Sterilox Food Safety/Div. of PuriCore
Manufacturer/Supplier: KAY Chemical Company, a Division of Ecolab, Inc.
Intended Use: For use as an antimicrobial agent in solutions used to re-hydrate fresh and fresh-cut fruits and vegetables.
Limitations/Specifications: On-site generation of the FCS solution will occur at least every 24 hours. The concentration of available free chlorine will not exceed 60 ppm, and the FCS solution will be replaced if the concentration falls below 25 ppm available free chlorine. Fresh and fresh-cut produce may be treated with the FCS solution by soaking for 90 seconds to 10 minutes or by spraying. After treatment, the produce will be allowed to drain for no less than 10 minutes before it is placed on display or consumed.
Effective Date: Jan 1, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 805 kb)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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