FCN No. 1919

Enviro Tech Chemical Services, 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: 2,6-Pyridinedicarboxylic acid (dipicolinic acid) (CAS Reg. No. 499-83-2).
• Notifier: Enviro Tech Chemical Services, Inc.
• Manufacturer/Supplier: Enviro Tech Chemical Services, Inc.
• Intended Use: To stabilize peroxyacid equilibrium mixtures during storage (i.e. before dilution with water and subsequent food-contact use, except for use in contact with infant formula or human milk (see Limitations/Specifications)).
• Limitations/Specifications: To be used in peroxyacetic acid solutions authorized in effective Food Contact Notifications with the following limitations in use level for:
  1. meat carcasses, parts, trim, and organs at a maximum use level of 1.64 ppm
  2. poultry carcasses, parts, trim, and organs at a maximum use level of 4.00 ppm
  3. processed and preformed meat and poultry at a maximum use level of 0.44 ppm
  4. fruits and vegetables in food processing facilities at a maximum use level of 0.68 ppm
  5. fish and seafood at a maximum use level of 0.38 ppm
  6. brines, sauces, and marinades at a maximum use level of 0.10 ppm, and
  7. the commercial sterilization of aseptic filling systems, glass and plastic food packaging and their enclosures prior to filling at a maximum use level of 9.0 ppm. If the peroxyacetic acid solution is applied at a rate exceeding 0.0175 milliliters treatment solution per ounce container capacity, the solution must be drained from the container and rinsed with sterile water and drained again.
  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: Dec 28, 2018
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 356 kB)
• FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 114 kB)

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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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