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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. 531

GE Healthcare

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 (chloromethyl)oxirane, 2-hydroxy-3-(2-hydroxy-3-(trimethylammonio)propoxy)propyl ethers, sulfate salts (CAS Reg. No. 846053-13-2).
Notifier: GE Healthcare
Manufacturer/Supplier: GE Healthcare
Intended Use: As an ion exchange resin.
Limitations/Specifications: For repeated use in extracting individual proteins or substances present in similar low concentrations from liquid, water-based food materials, such as milk, whey, fruit juice, beer and wine. For continuous use, the process conditions will be between pH 3 and 12 and temperatures below 40°C. Use at pH 12 up to 40°C is limited to a maximum of 2000 hours over the resin lifetime. Cleaning at 20°C may take place at up to pH 14, cleaning at 40°C conducted at up to pH 13.7, and cleaning at 60°C conducted at up to pH 13.3.
Effective Date: Oct 26, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo