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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. 1362

Eltron Research & Development, LLC
BioSafe Systems 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), glycerol (CAS Reg. No. 56-81-5), and optionally acetic acid (CAS Reg. No. 64-19-7) or sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Eltron Research & Development, LLC
Manufacturer/Supplier: Eltron Research & Development, LLC
BioSafe Systems LLC
Intended Use: As an antimicrobial agent on meat, poultry, fish and seafood, and fruits and vegetables that are not raw agricultural commodities.
Limitations/Specifications: The FCS will be added to process water or ice applied to (1)  meat carcasses, parts, trim, and organs at a level not to exceed 400 ppm peroxyacetic acid and 280 ppm hydrogen peroxide; (2) poultry parts, organs, and carcasses at a level not to exceed 1000 ppm peroxyacetic acid and 700 ppm hydrogen peroxide; (3) fish and seafood at a level not to exceed 190 ppm peroxyacetic acid and 140 ppm hydrogen peroxide; (4) fruits and vegetables that are not raw agricultural commodities at a level not to exceed 80 ppm peroxyacetic acid and 60 ppm hydrogen peroxide.
Effective Date: Feb 25, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 9.43 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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