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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. 443

Amersham Biosciences

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(3-sulfopropoxy)propyl ethers, sodium salts (CAS Reg. No. 676618-71-6).
Notifier: Amersham Biosciences
Manufacturer/Supplier: Amersham Biosciences
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. The process conditions include pH 3-14 and temperatures 5-60°C.
Effective Date: Sep 29, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo