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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. 1638

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 (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-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: The intended use of the FCS is as an antimicrobial agent for use in: 1) process water or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, hides, parts, trim, and organs as defined in 21 CFR 170.3 (n)(17)(29); 2) process water applied as a spray, wash, rinse, dip, chiller water, post-main chiller, secondary processing, pre-air chiller dip tanks and post-main water chiller systems as finishing chillers, low-temperature (e.g., less than 40°F) immersion baths, or scald water for poultry carcasses, parts and pieces, and skin on or off and organs; 3) process water, ice, or brine used for washing, rinsing, or cooling of processed and pre-formed meat and poultry products as defined in 21 CFR 170.3(n)(17)(18)(29)(34); 4) process water or ice used to commercially prepare fish and seafood; and 5) process water that contacts fruits and vegetables in a food processing facility.
Limitations/Specifications: The components of the FCS mixture will not exceed: 1) 460 ppm peroxyacetic acid, 220 ppm hydrogen peroxide, and 30 ppm HEDP on whole or cut meat (primarily as a spray); 2) 230 ppm peroxyacetic acid, 110 ppm hydrogen peroxide, and 15 ppm HEDP on processed and preformed meat and poultry; 3) 2000 ppm peroxyacetic acid, 950 ppm hydrogen peroxide, and 113 ppm HEDP on whole or cut poultry; 4) 230 ppm peroxyacetic acid, 110 ppm hydrogen peroxide, and 15 ppm HEDP on fish and seafood; 5) 350 ppm peroxyacetic acid, 165 ppm hydrogen peroxide, and 23 ppm HEDP on fruits and vegetables.
Effective Date: Jun 21, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 235 kB)
FDA Decision: Finding of No Significant Impact (FONSI)