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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. 1278


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 catalase (CAS Reg. No. 9001-15-2), glycerol (CAS Reg. No. 56-81-5), sodium citrate dihydrate (CAS Reg. No. 6132-04-3), sodium formate (CAS Reg. No.114-53-7), and 1,2-benziothiazolin-3-one (CAS Reg. No. 9001-05-2).
Notifier: Ecolab
Manufacturer/Supplier: Ecolab
Intended Use: As an adjuvant to antimicrobial solutions for use in commercial sterilization of aseptic filling systems and packaging prior to filling.
Limitations/Specifications: 1. The application rate will be a maximum of 13 ppm catalase in mixtures applied to polymeric food packaging containers (e.g., bottles and closures) for liquid and semi-solid flowable foods.; 2. Following the application of the FCS, the surfaces of the polymeric food packaging will be drained, rinsed with sterile water, and drained again.
Effective Date: Jul 3, 2013
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 417 kB)
FDA Decision: Finding of No Significant Impact (FONSI)