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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. 450

Bio-cide International, 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: An aqueous solution of sodium chlorite and chlorine dioxide containing up to 1200 mg/kg sodium chlorite and up to 30 mg/kg chlorine dioxide.
Notifier: Bio-cide International, Inc.
Manufacturer: Bio-cide International, Inc.
Intended Use: As an antimicrobial agent in the processing of red meat, red meat parts and organs, and on processed, comminuted, and formed meat products as a component of a dip or a spray.
Limitations/Specifications*: The additive is produced by mixing an aqueous solution of sodium chlorite with any generally recognized as safe acid to achieve a pH in the range of 2.2 to 3.0, then further diluting this solution with a pH elevating agent such that the resultant sodium chlorite concentration does not exceed 1200 mg/kg, and the chlorine dioxide concentration does not exceed 30 mg/kg. The pH of the use solution is between 5.0 and 7.5.
Effective Date: Nov 4, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (2.14 MB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement