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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. 1981

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-zinc-aluminum-calcium-sodium-borate-phosphate glass.
Notifier: Ishizuka Glass Co., Ltd.
Manufacturer/Supplier: Ishizuka Glass Co., Ltd.
Intended Use: As an antimicrobial agent in all types of food contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: For use only at levels not to exceed 3 percent by weight of the finished article in which the silver content of the finished article shall not exceed 0.045 percent by weight, under Conditions of Use A through H as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 5, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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