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U.S. Department of Health and Human Services

Inventory of Environmental Impact Decisions for Food Contact Substance Notifications
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FCN No. 45

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.
Environmental Assessment NEPA Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
FCN Premarket Authorization Issued: FCN description

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