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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. 535

Sinanen Zeomic Company, Ltd.

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 type of zeolite in which silver, copper and ammonium ions have been exchanged for sodium ions.
Notifier: Sciessent LLC
Manufacturer/Supplier: Sinanen Zeomic Company, Ltd.
Intended Use: To control microorganisms that may grow on the article and to thereby preserve the article.
Limitations/Specifications: The maximum percentage of the FCS in the article is 5 percent by weight. The silver content of the modified zeolite shall not exceed 5 percent by weight. The FCS will be used in repeat-use articles in contact with all types of food (I-IX) under Conditions of Use A through H as described in Tables 1 and 2, respectively.
Effective Date: Nov 11, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo