Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2198
Bioionix, 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). |
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Notifier: | Bioionix, Inc. |
Manufacturer/Supplier: | Bioionix, Inc. |
Intended Use: | For single use as an antimicrobial agent in an aqueous solution in the production and preparation of whole or cut meat and poultry; processed and preformed meat and poultry; fish and seafood; fruits and vegetables; plant-based proteins used as meat substitutes; shell eggs and cheese, except in contact with infant formula and human milk (see Limitations/Specifications). |
Limitations/Specifications: |
The FCS will be manufactured by a device on-site and the concentration of available free chlorine at the point-of use of the FCS will not exceed 60 ppm for any process but is limited to a maximum 6 ppm for cheese salt brining. The aqueous solution containing the FCS may be used in processing facilities as follows:
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Effective Date: | Apr 28, 2022 |
National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 1.3 MB) |
FDA Decision: | Finding of No Significant Impact (FONSI) & EA Revision Sheet (in PDF, 257 kB) |
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