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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. 1965

The Nikka Whisky Distilling 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: Aluminum silicon silver oxide with sodium zeolite Y (CAS Re. No. 308081-05-2).
Notifier: The Nikka Whisky Distilling Co., Ltd.
Manufacturer/Supplier: The Nikka Whisky Distilling Co., Ltd.
Intended Use: For repeated use in filtering of distilled alcoholic beverages.
Limitations/Specifications: The FCS may only be used in filtration systems used during the whiskey manufacturing process at a maximum temperature of 40°C.
Effective Date: May 28, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo