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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. 2046

Ecolab Inc.

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-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9). REPLACES FCNs 1968, 1745, 1495, 1236, 1096, 921 and 140
Notifier: Ecolab Inc.
Manufacturer/Supplier: Ecolab Inc.
Intended Use: As an antimicrobial agent used in:
  1. process water, ice, or brine used in the production, processing, and preparation of poultry, meat, processed and pre-formed meat and poultry, fruits, vegetables, fish, seafood, shell eggs, and hard-boiled,peeled eggs.
  2. brines, marinades, and sauces applied on the surface or injected into processed or unprocessed, cooked or uncooked, whole or cut, meat and poultry.
  3. surface sauces and marinades applied on processed and pre-formed meat and poultry products.
  4. the commercial sterilization of aseptic filling systems and food packaging 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, 136 ppm HEDP, and 6.7 ppm DPA in process water, ice, or brine applied as a wash, spray, dip, rinse, chiller water, low-temperature (less than 40°F) immersion bath, or scald water for whole or cut poultry, including carcasses, parts, trim, and organs.
  2. 495 ppm PAA, 1180 ppm HP, 29 ppm HEDP, and 0.44 ppm DPA in process water, ice, or brine for washing, rinsing, or cooling processed and pre-formed poultry.
  3. 2000 ppm PAA, 1474 ppm HP, 121.5 ppm HEDP, and 6.7 ppm DPA in process water, ice, or brine applied as a wash, spray, dip, rinse, chiller water, low-temperature (less than 40°F) immersion bath, or scald water for whole or cut meat, including carcasses, parts, trim, and organs.
  4. 495 ppm PAA, 1180 ppm HP, 33.5 ppm HEDP, and 0.44 ppm DPA in process water, ice, or brine for washing, rinsing, or cooling processed and pre-formed meat.
  5. 500 ppm PAA, 1000 ppm HP, 34 ppm HEDP, and 2 ppm DPA in process water or ice used for washing, rinsing, chilling, or processing fruits and vegetables in food processing facilities.
  6. 230 ppm PAA, 280 ppm HP, 15 ppm HEDP, and 0.8 ppm DPA in process water, ice, or brine used during commercial preparation of fish and seafood in food processing facilities.
  7. 2000 ppm PAA, 947 ppm HP, 120 ppm HEDP, and 6.7 ppm DPA in wash water for shell eggs in food processing facilities.
  8. 2000 ppm PAA, 1447 ppm HP, 85 ppm HEDP, and 6.7 ppm DPA in spray, wash, dip, rinse, mist, or chiller water of hard-boiled, peeled eggs.
  9. 50 ppm PAA, 33 ppm HP, 8 ppm HEDP, and 0.1 ppm DPA in brines, marinades, and sauces applied to the surface or injected into processed or unprocessed, cooked or uncooked, whole or cut, meat and poultry.
  10. 50 ppm PAA, 33 ppm HP, 8 ppm HEDP, and 0.1 ppm DPA in surface sauces and marinades applied on processed and pre-formed meat and poultry products.
  11. 4500 ppm PAA, 6600 ppm HP, 600 ppm HEDP, and 9 ppm DPA in the commercial sterilization of aseptic filling systems and food packaging prior to filling. The surfaces of food packaging will be drained, rinsed, and drained again following application of the FCS mixture.
FDAs review of the use of the FCS in 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: Jul 21, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 873 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 158 kB)

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