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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. 697

Cosmo Advanced Material 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 and zinc ions have been exchanged for sodium ions.
Notifier: Cosmo Advanced Material Company, Ltd.
Manufacturer: Cosmo Advanced Material Company, Ltd.
Intended Use: As an antimicrobial agent used to preserve food contact polymers intended for repeat use articles.
Limitations/Specifications*: The silver content of the FCS shall not exceed 5.0 percent by weight. The finished, repeat-use polymer may contain up to 5.0 percent by weight of the FCS and contact all food types under Conditions of Use A through H as described in Table 2.
Effective Date: Apr 27, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo