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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. 2352

Clean Chemistry 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), sodium acetate (CAS Reg. No. 127-09-3), and glycerol (CAS Reg. No. 56-81-5).
Notifier: Clean Chemistry Inc.
Manufacturer/Supplier: Clean Chemistry Inc.
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. during the tempering and before milling of grains of wheat, corn, and rice;
  6. in water for washing shell eggs;
  7. in spray, wash, dip, rinse, mist, or chiller water for hard boiled, peeled eggs;
  8. in liquid, pasteurized whey used in the production of whey protein concentrate;
  9. in wash water used to manufacture lactose;
  10. 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;
  11. in surface sauces and in marinades applied on processed and preformed meat and poultry products;
  12. alone or in combination with other processes in the commercial sterilization of aseptic filling systems and glass and plastic food packaging and their closures prior to filling,
except for use in contact with infant formula and human milk, on food packaging used in contact with infant formula and human milk, or aseptic filling equipment used to fill food packaging used in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The components of the FCS will not exceed:
  1. 2000 ppm PAA and 44.4 ppm HP in spray, wash, rinse, dip, chill, and scald process water, ice, or brine used in the production, processing, and preparation of whole or cut meat and poultry carcasses, parts, trim, and organs;
  2. 495 ppm PAA and 11 ppm HP in process water, ice, or brine used for washing, rinsing, or cooling of processed and preformed meat and poultry;
  3. 600 ppm PAA and 13.3 ppm HP in process water or ice for washing, rinsing, chilling or processing fruits and vegetables in food processing facilities;
  4. 230 ppm PAA and 5.1 ppm HP in process water and ice used to commercially prepare fish and seafood;
  5. 6000 ppm PAA and 133.3 ppm HP when applied during the tempering and before milling of grains of wheat, corn, and rice applied at a level not to exceed 3% by weight of the grain;
  6. 2000 ppm PAA and 44.4 ppm HP in water for washing shell eggs;
  7. 2000 ppm PAA and 44.4 ppm HP in spray, wash, dip, rinse, mist, or chiller water for hard boiled, peeled eggs;
  8. 15 ppm PAA and 0.33 ppm HP in liquid, pasteurized whey used in the production of whey protein concentrate;
  9. 30 ppm PAA and 0.67 ppm HP in wash water used to manufacture lactose;
  10. 50 ppm PAA and 1.1 ppm HP 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;
  11. 50 ppm PAA and 1.1 ppm HP in surface sauces and in marinades applied on processed and preformed meat and poultry products;
  12. 4500 ppm PAA and 100 ppm HP when applied to aseptic filling systems and glass and plastic food packaging and their closures prior to filling. The FCS is not for use in contact with infant formula and human milk.

The FCS is also not for use on food packaging used in contact with infant formula and 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: Feb 14, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 235 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 177 kB)
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