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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. 248

Kanebo Chemical Industries, 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: Silver zinc glass, of nominal composition silver (0.47 percent +/- 0.1 percent)-zinc (21 percent +/- 2.0 percent)-aluminum-boron phosphate (=/> 76.4 percent) glass.
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: Kanebo Chemical Industries, Ltd.
Intended Use: The food contact substance (FCS) will be used as an antimicrobial agent in all types of food-contact polymers.
Limitations/Specifications: The FCS will be used in contact with all types of food at levels not to exceed 3.0 percent by weight of the finished polymers. The silver content of the FCS shall not exceed 0.57 percent by weight.
Effective Date: Aug 16, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo