Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 1284
Diversey, Inc. and Cryovac, 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 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), water, and optionally, sulfuric acid (CAS Reg. No. 7664-93-9). |
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| Notifier: | Diversey, Inc. and Cryovac, Inc. |
| Manufacturer/Supplier: | Diversey, Inc. and Cryovac, Inc. |
| Intended Use: | As an antimicrobial agent for use in: 1) process water or ice used for washing, rinsing, storing, or cooling whole or cut meat, including carcasses, parts, trim, and organs; 2) process water, ice, or brine used for washing, rinsing, storing, or cooling of processed and pre-formed meat as defined in 21 CFR 170.3(n)(29) and poultry as defined in 21 CFR 170.3(n)(34); 3) process water applied as a spray, wash, rinse, dip, chiller water, low-temperature (e.g., less than 40°F) immersion baths, or scald water for poultry carcasses, parts, and organs; 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: | In whole or cut meat (primarily as a spray), the components of the FCS mixture will not exceed 400 ppm peroxyacetic acid, 280 ppm hydrogen peroxide, and 20 ppm HEDP. In processed and preformed meat and poultry, the components of the FCS mixture will not exceed 230 ppm peroxyacetic acid, 280 ppm hydrogen peroxide, and 14 ppm HEDP. In whole or cut poultry, the components of the FCS mixture will not exceed 2000 ppm peroxyacetic acid and 136 ppm HEDP. In fish and seafood, the components of the FCS mixture will not exceed 230 ppm peroxyacetic acid, 280 ppm hydrogen peroxide, and 14 ppm HEDP. In fruits and vegetables, the components of the FCS mixture will not exceed 80 ppm peroxyacetic acid, 120 ppm hydrogen peroxide, and 10 ppm HEDP. |
| Effective Date: | Sep 10, 2013 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 733 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
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