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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. 1639

Biosan 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-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Biosan LLC
Manufacturer/Supplier: Biosan LLC
Intended Use: As an antimicrobial agent in process water, brine, and ice used in the production and preparation poultry, meat, processed and pre-formed meat and poultry, 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), 120 ppm HEDP and 0.5 ppm DPA in spray, wash, rinse, dip, chiller water, low-temperature (e.g., less than 40°F) immersion baths, or scald water for whole or cut poultry carcasses, parts, trim, and organs; (2) 400 ppm PAA, 187 ppm HP, 24 ppm HEDP, and 0.5 ppm DPA in process water, ice, or brine used for washing, rinsing, or cooling of whole or cut meat, including carcasses, parts, trim, and organs; (3) 230 ppm PAA, 107 ppm HP, 14 ppm HEDP, and 0.1 ppm DPA in process water, ice, or brine used for washing, rinsing, 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); and (4) 80 ppm PAA, 37 ppm HP, 5 ppm HEDP, and 0.25 ppm DPA in process water for washing or chilling fruits and vegetables in food processing facilities.
Effective Date: Jun 3, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (201 kB)
FDA Decision: Finding of No Significant Impact (FONSI)