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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. 2096

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 (AA) (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 (SA) (CAS Reg. No. 7664-93-9). REPLACES FCN 2059
Notifier: Hydrite Chemical Co.
Manufacturer/Supplier: Hydrite Chemical Co.
Intended Use: As an antimicrobial agent used 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 in the commercial sterilization of aseptic filling systems and food packaging and their closures prior to filling. The surfaces of food packaging and their closures will be drained, rinsed, and drained again following application of the FCS mixture. FDA’s 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 26, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 216 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 134 kB)

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