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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. 1783

Eltron Research & Development, LLC
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), glycerol (CAS Reg. No. 56-81-5), and optionally acetic acid (CAS Reg. No. 64-19-7) or sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Eltron Research & Development, LLC
Manufacturer/Supplier: Eltron Research & Development, LLC
BioSafe Systems LLC
Intended Use: As an antimicrobial to control microorganisms in process water used during the commercial preparation of processed meat and poultry, fish and seafood, and fruits and vegetables that are not raw agricultural commodities.
Limitations/Specifications: The FCS will be added to process water as a spray, dip, ice chiller water or scald water for washing, rinsing, or cooling meat, poultry, fish and seafood, and fruits and vegetables that are not raw agricultural commodities. Final at-use concentrations of peroxyacetic acid and hydrogen peroxide are limited to:
  1. 1800 ppm peroxyacetic acid and 1215 ppm hydrogen peroxide in water for whole and cut meat carcasses, parts, trim, and organs;
  2. 2000 ppm peroxyacetic acid and 1474 ppm hydrogen peroxide in water for whole or cut poultry carcasses, parts, trim, and organs;
  3. 230 ppm peroxyacetic acid and 165 ppm hydrogen peroxide in water for fish and seafood; and
  4. 350 ppm peroxyacetic acid and 525 ppm hydrogen peroxide in water for fruits and vegetables that are not raw agricultural commodities.
Effective Date: Sep 8, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.7 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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