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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. 921

Ecolab, 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: A mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,1-diphosphonic acid, with or without a catalase enzyme adjuvant solution.
Notifier: Ecolab, Inc.
Manufacturer: Ecolab, Inc.
Intended Use: As an antimicrobial additive that may be used alone or in combination with other processes in the commercial sterilization of asceptic filling systems and packaging prior to filling.
Limitations/Specifications*: 1) The composition of the food-contact substance mixture will not exceed 600 parts per million (by weight) 1-hydroxyethylidine-1,1-diphosphonic acid, with or without 12 parts per million (by weight) of the active catalase enzyme. 2) The surfaces of the polymeric food packaging will be drained, rinsed, and drained again following the application of the food-contact substance mixture.
Effective Date: Nov 12, 2009
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.60 MB)
FDA Decision: Finding of No Significant Impact (FONSI)