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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. 434

Ishizuka Glass Co., 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-magnesium-calcium-phosphate-borate-glass.
Notifier: Ishizuka Glass Co., Ltd.
Manufacturer: Ishizuka Glass Co., Ltd.
Intended Use: As an antimicrobial agent in all polymers.
Limitations/Specifications*: For use only at levels not to exceed 1 percent by weight of the finished article, in which the silver content of the finished article shall not exceed 0.03 percent by weight, under Conditions of Use A through H.
Effective Date: Oct 12, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo