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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. 45

Life Technologies, Inc.

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: Two quaternary amine (QAE) cellulose ion exchange resins (IXRs): (1) high substitution QAE cellulose IXR (1.5-2.5 milliequivalents quaternary ammonium per dry g of resin); and (2) high protein capacity QAE cellulose IXR (1.0-1.5 milliequivalents quaternary ammonium per dry g resin). Both IXRs consist of a base matrix of regenerated cellulose, cross-linked and alkylated with epichlorohydrin and propylene oxide. Dimethyl hydroxyethyl ammonium groups are added to the polymer to provide binding sites.
Notifier: Life Technologies, Inc.
Manufacturer/Supplier: Life Technologies, Inc.
Intended Use: For use in the isolation and purification of protein concentrates and isolates from aqueous process streams for food processing.
Limitations/Specifications*: The amount of epichlorohydrin plus propylene oxide employed in manufacture of the resins does not exceed 400 percent by weight of the starting quantity of cellulose. The resins comply with the requirements listed in 21 CFR 173.25(c) and 21 CFR 173.25(d)(2)(ii). The resins shall be used only in the pH range from 2 to 10. The temperatures of water and food passing through the resins shall not exceed 50°C.
Effective Date: Jun 10, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)