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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. 1501

Arkema Inc. and Biosafe Systems

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 (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Arkema Inc.
Manufacturer/Supplier: Arkema Inc. and Biosafe Systems
Intended Use: As an antimicrobial to control microorganisms in process water and ice used in the production and preparation of poultry, shell eggs, meat, processed and pre-formed meat and poultry, fish and seafood, and fruits and vegetables.
Limitations/Specifications: The components of the FCS mixture will not exceed: (1) 2000 ppm peroxyacetic acid (PAA), 933 ppm hydrogen peroxide (HP), and 120 ppm 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) in spray, wash, rinse, dip, chiller water, low-temperature (e.g., less than 40°F) immersion baths, scald water for whole or cut poultry carcasses, parts, trim, skin on or off, and organs, and shell egg washes; (2) 400 ppm PAA, 187 ppm HP, and 24 ppm HEDP in process water or ice used for washing, rinsing, storing, or cooling whole or cut meat, including carcasses, parts, trim, and organs; (3) 230 ppm PAA, 107 ppm HP, and 14 ppm HEDP in 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); (4) 230 ppm PAA, 107 ppm HP, and 14 ppm HEDP in process water or ice used during commercial preparation of fish and seafood; and (5) 80 ppm PAA, 37 ppm HP, and 5 ppm HEDP in process water for washing or chilling fruits and vegetables in food processing facilities.
Effective Date: Mar 21, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 3.8 Mb)
FDA Decision: Finding of No Significant Impact (FONSI)

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