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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. 2186

Clarentis Technologies 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: Hypochlorous acid (CAS Reg. No. 7790?92?3).
Notifier: Clarentis Technologies LLC
Manufacturer/Supplier: Clarentis Technologies LLC
Intended Use: For single use as an antimicrobial agent in solutions used to rehydrate fresh and fresh-cut fruits and vegetables in food processing facilities, except in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The concentrated FCS solution will be stored for no more than six months before use. In the diluted solution, the concentration of free available chlorine will not exceed 60 ppm, and the FCS solution will be replaced if the concentration falls below 25 ppm available free chlorine. Fresh and fresh-cut produce may be treated with the FCS solution by soaking for a minimum of 90 seconds or by spraying. After treatment, the produce will be allowed to drain for no less than 10 minutes before it is placed on display or consumed. 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: Apr 26, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.0 MB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 255 kB)

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