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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. 1911

Xgenex, LLC

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 mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethane 1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Xgenex, LLC
Manufacturer/Supplier: Xgenex, LLC
Intended Use: As an antimicrobial agent in process water and ice used in the production, processing, and preparation of meat.
Limitations/Specifications*: The components of the FCS mixture will not exceed 2000 ppm PAA, 950 ppm HP, and 57 ppm HEDP in process water and ice that contacts whole or cut meat carcasses, parts, trim, and organs.
Effective Date: Dec 6, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF)

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