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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. 484

NOVA Chemicals 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: Isobutylene-butene copolymer (CAS Reg. No. 9044-17-1).
Notifier: NOVA Chemicals Inc.
Manufacturer: NOVA Chemicals Inc.
Intended Use: For use as a process aid in the manufacture of styrene-maleic anhydride copolymers complying with 21 CFR 177.1820(b)(2).
Limitations/Specifications*: Molecular weight (range): 150-6500. Viscosity (range): 200-235 cST (100°C). Maximum bromine value: 90. At levels not to exceed 4 percent by weight of styrene-maleic anhydride resins used to fabricate non-film food-contact articles. The FCS is primarily intended for single-service applications. The FCS will be used in contact with: (1) refrigerated or frozen food (Conditions of Use F and G); (2) refrigerated or frozen food that may be microwave reheated; (3) takeout food items that have been hot filled; and (4) aqueous and acidic foods for use as components of food processing machinery at temperatures not to exceed 100°C for up to five minutes.
Effective Date: Apr 6, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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