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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. 1851

Enviro Tech Chemical Services, 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 mixture 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), 1-hydroxyethylidene-1,1-disphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).
Notifier: Enviro Tech Chemical Services, Inc.
Manufacturer/Supplier: Enviro Tech Chemical Services, Inc.
Intended Use: As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of aseptic filling systems and glass and plastic food packaging and their enclosures 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 mixture will not exceed 4500 ppm peroxyacetic acid, 6600 ppm hydrogen peroxide, and 180 ppm HEDP. 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. FDAs review of the use of the FCS to sterilize 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: Apr 1, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 560 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 124 kB)

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