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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. 47

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 in which silver, zinc and ammonium ions have been exchanged for sodium ions. The silver content of the modified zeolite shall not exceed 2.5 percent by weight.
Notifier: Sinanen Zeomic Company, Ltd.
Manufacturer/Supplier: Sinanen Zeomic Company, Ltd.
Intended Use: As an antimicrobial agent to supplement the sterilization of aseptic food-contact polymers.
Limitations/Specifications: The FCS will be used at levels not to exceed 5 percent by weight of the finished polymer. 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: Jun 9, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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