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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. 807

Xyrex Ltd.

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: Mixture of sodium chlorite (CAS Reg. No. 7758-19-2) and sodium chloride (CAS Reg. No. 7647-14-5).
Notifier: Xyrex Ltd.
Manufacturer/Supplier: Xyrex Ltd.
Intended Use: As an antimicrobial agent in water and ice that are used to rinse, wash, thaw, transport, or store seafood in accordance with current industry standards of good manufacturing practice.
Limitations/Specifications: The FCS is produced by diluting an aqueous solution of sodium chlorite at pH 12-13 with water to achieve an actual at use concentration of 12.5 to 25 ppm sodium chlorite. Any seafood that is intended to be consumed raw shall be subjected to a potable water rinse prior to consumption.
Effective Date: Jun 5, 2008
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 100 kB)
FDA Decision: Finding of No Significant Impact (FONSI)