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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. 2036

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 (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-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). REPLACES FCN 1639
Notifier: Biosan LLC
Manufacturer/Supplier: Biosan LLC
Intended Use: As an antimicrobial agent used:
  1. in process water, ice or brine used in washing, rinsing, scalding, or cooling whole or cut meat and poultry carcasses, parts, trim, and organs.
  2. in process water, ice, or brine used in washing, rinsing, or cooling processed and preformed meat and poultry products.
  3. in process water or ice for washing, rinsing, chilling or processing fruits and vegetables in food processing facilities.
  4. in process water and ice used to commercially prepare fish and seafood.
  5. in brines, sauces, and marinades applied either on the surface or injected into processed or unprocessed, cooked, or uncooked, whole or cut poultry parts or pieces.
  6. in surface sauces and in marinades applied on processed and preformed meat and poultry products.
  7. alone or in combination with other processes in the commercial sterilization of aseptic filling systems and glass and plastic food packaging and their enclosures prior to filling, except for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging (see Limitations/Specifications).
Limitations/Specifications: The components of the FCS will not exceed:
  1. 2000 ppm PAA, 1474 ppm HP, 121.5 ppm HEDP, and 1.64 ppm DPA in process water, ice, or brine used in washing, rinsing, scalding, or cooling whole or cut meat carcasses, parts, trim, and organs.
  2. 2000 ppm PAA, 1474 ppm, HP, 136 ppm HEDP, and 4 ppm DPA in process water, ice, or brine used in washing, rinsing, scalding, or cooling whole or cut poultry carcasses, parts, trim, and organs.
  3. 495 ppm PAA, 365 ppm HP, 33.5 ppm HEDP, and 0.44 ppm DPA in process water, ice, or brine used in washing, rinsing, or cooling processed and pre-formed meat products.
  4. 495 ppm PAA, 365 ppm HP, 29 ppm HEDP, and 0.44 ppm DPA in process water, ice, or brine used in washing, rinsing, or cooling processed and pre-formed poultry products.
  5. 500 ppm PAA, 1000 ppm HP, 34 ppm HEDP, and 0.68 ppm DPA in process water or ice used in washing, rinsing, chilling or processing fruits and vegetables in food processing facilities.
  6. 230 ppm PAA, 280 ppm HP, 15 ppm HEDP, and 0.38 ppm DPA in process water and ice used to commercially prepare fish and seafood.
  7. 50 ppm PAA, 33 pm HP, 8 ppm HEDP, and 0.1 ppm DPA in brines, sauces, and marinades applied either on the surface or injected into processed or unprocessed, cooked, or uncooked, whole or cut poultry parts or pieces.
  8. 50 ppm PAA, 33 pm HP, 8 ppm HEDP, and 0.1 ppm DPA in surface sauces and in marinades applied on processed and preformed meat and poultry products.
  9. 4500 ppm PAA, 6600 ppm HP, 180 ppm HEDP, and 9 ppm DPA when applied to aseptic filling systems and glass and plastic food packaging and their enclosures prior to filling. If the FCS mixture is applied at a rate exceeding 0.0175 milliliters treatment solution per ounce container capacity, the FCS mixture must be drained from the container and rinsed with sterile water and drained again. FDAs review of the use of the FCS to sterilize aseptic filling systems is limited to the extent that the FCS residues may transfer from the non-food contact surfaces of the aseptic filling system to food packaging materials. The FCS is not for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Apr 2, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 554 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 133 kB)

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