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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. 1397

Pall Corporation

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: Copolymer of polyethylene glycol dimethacrylate, trimethylolpropane trimethacrylate and 2-hydroxyethyl methacrylate.
Notifier: Smithers Pira
Manufacturer/Supplier: Pall Corporation
Intended Use: Use as repeat microbial filter intended to clarify beer and wine.
Limitations/Specifications: The FCS will be used in a membrane cartridge for filtration of beer and wine. The membrane cartridge is to be manufactured and used as specified in the submission.
Effective Date: Mar 25, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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