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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. 1532

Nestlé Infant Nutrition and Sartorius Stedim Biotech GmbH

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: Acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone (CAS Reg. No. 25086-89-9)
Notifier: Nestlé Nutrition U.S.
Manufacturer/Supplier: Nestlé Infant Nutrition and Sartorius Stedim Biotech GmbH
Intended Use: To serve as a pore forming agent in the production of microporous poly(1,4-phenylenether-sulfone) membranes
Limitations/Specifications: The finished membrane is intended to filter water only in contact with powdered infant formula and powdered toddler beverages at ambient temperature to a maximum temperature of 45° C.
Effective Date: May 15, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 908 kb)
FDA Decision: Finding of No Significant Impact (FONSI)