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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 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 Company, Ltd.
Manufacturer: Sinanen Company, Ltd.
Intended Use: As an antimicrobial additive in all types of food-contact polymers.
Limitations/Specifications*: Maximum use level of 5 percent by weight of the 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)
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