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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. 2210

Hydrite Chemical Co.

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 (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Hydrite Chemical Co.
Manufacturer/Supplier: Hydrite Chemical Co.
Intended Use: As an antimicrobial agent used alone or in combination with other processes in the commercial sterilization of aseptic filling systems and glass and plastic food packaging and their closures prior to filling, except for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging (see Limitations/Specifications).
Limitations/Specifications: The components of the FCS will not exceed 4500 ppm PAA, 6600 ppm HP, 240 ppm HEDP, and 9 ppm DPA when used in the commercial sterilization of aseptic filling systems and glass and plastic food packaging and their closures prior to filling. If the FCS mixture is applied at a rate exceeding 0.0175 milliliters treatment solution per ounce container capacity, the FCS mixture must be drained from the container and rinsed with sterile water and drained again. 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: Apr 6, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.0 MB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 222 kB)

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