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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. 1403

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: To be used in repeat-use membrane filtration of beer and water for microbial removal and clarification, except for use in filtration of water used in processing infant formula (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used in a membrane cartridge for filtration of beer and water. The membrane cartridge is to be manufactured and used as specified in the submission. The FCS is not for use in filtration of water for use in processing infant formula. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Apr 11, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo