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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. 1509

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: The FCS is intended for repeat use as a microbial filter.
Limitations/Specifications: The FCS will be used in membrane cartridges in filters for bottled water. Permitted uses for infant formula: The FCS may be used in filters for bottled water intended for use in the preparation of infant formula.
Effective Date: Feb 19, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo