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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. 435

Cellresin Technologies, LLC Equistar Chemicals, LP

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: Poly(ethylene-maleic anhydride) grafted cyclodextrin(s).
Notifier: Cellresin Technologies, LLC Equistar Chemicals, LP
Manufacturer: Cellresin Technologies, LLC Equistar Chemicals, LP
Intended Use: For use as an adjuvant in the manufacture of polymer beverage container closures and beverage and food container seals.
Limitations/Specifications*: The FCS is intended to be blended with polymers compliant with 21 CFR 177.1210 (Closures with sealing gaskets for food containers) and/or appropriate effective FCNs to form finished beverage container closures and beverage and food container seals. The maximum concentration of the FCS will not exceed 2.0 percent by weight of the cyclodextrins and 15 percent by weight of maleic-anhydride-polyethylene copolymer in the finished closure. The finished food-contact closures may contact beverages of food types I, II, VI-A, and VI-B identified in Table 3 of 21 CFR 177.1210(c) and under Conditions of Use C through G identified in Table 2.
Effective Date: Sep 14, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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