FCN No. 1799

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 (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).
• Notifier: Biosan, LLC
• Manufacturer/Supplier: Biosan, LLC
• Intended Use: As an antimicrobial agent in: (1) process water or ice used to commercially prepare fish and seafood; (2) brines, sauces, and marinades applied either on the surface or injected into processed or unprocessed, cooked or uncooked whole or cut poultry, and (3) surface sauces and marinades applied on processed and preformed meat and poultry products as described in 21 CFR 170.3(n)(29) and (34).
• Limitations/Specifications: The components of the FCS mixture will not exceed:
  1. 230 ppm peroxyacetic acid, 110 ppm hydrogen peroxide, and 15 ppm 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) on fish and seafood;
  2. 50 ppm peroxyacetic acid, 18 ppm hydrogen peroxide, and 6 ppm as HEDP on processed or unprocessed, cooked or uncooked whole or cut poultry; and
  3. 50 ppm peroxyacetic acid, 18 ppm hydrogen peroxide, and 6 ppm as HEDP on processed and preformed meat and poultry.
• Effective Date: Sep 13, 2017
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 606 kB)
• FDA Decision: Finding of No Significant Impact (FONSI)

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*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.

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