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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. 1810

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), 1-hydroxyethylidine-1, 1-disphosphonic acid (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 766-93-9).
Notifier: BioSafe Systems LLC
Manufacturer/Supplier: BioSafe Systems LLC
Intended Use: As an antimicrobial in process water, brine, and ice used in the production and preparation of whole or cut meat.
Limitations/Specifications: The components of the FCS mixture will not exceed 1800 ppm peroxyacetic acid (PAA), 675 ppm hydrogen peroxide (HP), and 51.4 ppm 1-hydroxyethylidine-1, 1-disphosphonic acid (HEDP) in process water, brine, or ice used for washing, rinsing, or cooling whole or cut meat, including carcasses, parts, trim, and organs.
Effective Date: Nov 30, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 130 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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