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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. 2262

Seriously Clean Ltd.

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: Seriously Clean Ltd.
Manufacturer/Supplier: Seriously Clean Ltd.
Intended Use: For use as an antimicrobial agent in an aqueous solution in the production and preparation of fish and seafood; fruits and vegetables; and shell eggs, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS solutions will be stored for no more than six months before use. The concentration of available free chlorine in the diluted solution will not exceed 60 parts per million (ppm). The diluted solution containing the FCS may be used in processing facilities and retail food establishments as follows:
  1. in process water or ice for washing, rinsing, rehydrating, or cooling fruits, and vegetables;
  2. in ice for cooling whole or cut fish and seafood; and
  3. in process water for washing or rinsing shell eggs;
When used to process fruits, vegetables, and fish and seafood products intended to be consumed raw, the treatment will be followed by either a 10-minute drain step or a potable water rinse to remove, to the extent possible, residues of the FCS. 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: Jan 25, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1 MB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 233 kB)

*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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