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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. 773

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: Zeolite A (CAS Reg. No. 68989-22-0) in which silver and ammonium ions have been exchanged for sodium ions.
Notifier: Sciessent LLC
Manufacturer: Sinanen Zeomic Company, Ltd.
Intended Use: As an antimicrobial agent used to preserve food-contact polymers.
Limitations/Specifications*: The finished polymers contain the FCS at not more than 5 percent by weight. The silver content shall 1) not exceed 0.125 percent by weight in polymers to be used in aseptic packaging, 2) not exceed 0.05 percent by weight in single-use polymers other than aseptic packaging , and 3) not exceed 0.25 percent by weight in repeat-use polymers. The finished polymers are intended to contact all types of food under Conditions of Use A through H as described in Table 2.
Effective Date: Jan 22, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo