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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

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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:  GE Healthcare
Intended Use:  As an ion exchange resin.
Effective Date:  10/26/2005
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.
Environmental Impact Decisions:  Environmental Decisions Site