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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. 193

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 zeolite, a mixture of silver-magnesium-zinc-calcium phosphate sodium alumino silicate, zinc oxide (CAS Reg. No. 1314-13-2), and hydrotalcite (CAS Reg. No. 12304-65-3).
Notifier: Ciba Specialty Chemicals Corp.
Manufacturer/Supplier: Kanebo Chemical Industries, Ltd.
Intended Use: The 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 foods at levels not to exceed 3.0 percent by weight of the finished polymers, in which the silver content of the FCS shall not exceed 0.55 percent by weight.
Effective Date: Mar 6, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo