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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. 1609

GE Healthcare Bio-Sciences AB

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: Agarose, polymer with 2-(chloromethyl)oxirane, 2-hydroxy-3-(2-propen-1-yloxy)propyl ether, polymer with 1-ethenyl-2-pyrrolidinone, graft (CAS Reg. No. 1613113-98-6).
Notifier: GE Healthcare Bio-Sciences AB
Manufacturer/Supplier: GE Healthcare Bio-Sciences AB
Intended Use: As a repeat-use chromatography medium for selective adsorption of undesirable haze and particulate forming polyphenols in beer.
Limitations/Specifications: The FCS may be used under process conditions between pH 4 to 7 and temperatures below 5 °C. Cleaning at 20 °C may take place at pH 14 and is limited to 500 hours over the service lifetime. Sanitation with hot water may take place at 85 ºC and is limited to 250 hours over the service lifetime. The FCS is not for use at acidic pH ≤ 3.
Effective Date: Jan 26, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.5 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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