FCN No. 2322

Agri-Neo 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 solution 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), sulfuric acid (CAS Reg. No. 7664-93-9), and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4). REPLACES FCN 2100
• Notifier: Agri-Neo Inc.
• Manufacturer/Supplier: Agri-Neo Inc.
• Intended Use: As an antimicrobial agent for use as a spray on (1) seeds for sprouting (alfalfa, clover, broccoli, flax, and chia), edible seeds (chia, flax, hemp, millet hulled, pumpkin, sesame, sunflower kernel, and quinoa), and nuts (almond, cashew, walnut, Brazil nuts, hazelnuts, macadamia and pecans), and (2) pulses (peas, beans, lentils, and chickpeas), soybeans, and all herbs and spices, except for use in contact with infant formula and human milk (see Limitations/Specifications).
• Limitations/Specifications: The components of the FCS on:
  1. seeds and nuts will not exceed 229 parts per million (ppm) peroxyacetic acid, 1043 ppm hydrogen peroxide, 388 ppm acetic acid, 48 ppm sulfuric acid, and 25 ppm HEDP;
  2. pulses (peas, beans, lentils, and chickpeas), soybeans, and all herbs and spices will not exceed 459 parts per million (ppm) peroxyacetic acid, 2459 ppm hydrogen peroxide, 1117 ppm acetic acid, 99 ppm sulfuric acid, and 59 ppm HEDP.
  The FCS will be applied in the preparing, packing, or holding of the food for commercial purposes, consistent with the FD&C Act section 201(q)(1)(B)(i). The treated seeds for sprouting are intended to be consumed as sprouts. The treated edible seeds may be consumed directly or further processed into flour, protein, or oil. The treated edible nuts are intended to be consumed as nuts. The treated pulses may be consumed directly. The treated soybeans may be consumed directly or further processed into flour, isolate, meal, or oil. The treated herbs and spices may be consumed directly. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
• Effective Date: Feb 15, 2024
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 638 kB)
• FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 152 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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