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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. 1554

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), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 02809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: BioSafe Systems, LLC
Manufacturer/Supplier: BioSafe Systems, LLC
Intended Use: As an antimicrobial to control microorganisms in process water and ice used in the production and preparation of fruits and vegetables.
Limitations/Specifications: The components of the FCS mixture will not exceed 350 ppm peroxyacetic acid , 117 ppm hydrogen peroxide, 10 ppm HEDP in process water for washing or chilling fruits and vegetables in food processing facilities
Effective Date: Oct 27, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 574 kb)
FDA Decision: Finding of No Significant Impact (FONSI)