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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. 1104

TOPAS Advanced Polymers, Inc. and TOPAS Advanced Polymers GmbH

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: Bicyclo[2.2.1]hept-2-ene, polymer with ethene (CAS Reg. No. 26007-43-2).
Notifier: TOPAS Advanced Polymers, Inc. and TOPAS Advanced Polymers GmbH
Manufacturer: TOPAS Advanced Polymers, Inc. and TOPAS Advanced Polymers GmbH
Intended Use: As a basic polymer in the production of articles that may contact food.
Limitations/Specifications*: The FCS contains 3 - 12 mole-percent norbornene and may contact food types I, II, IV-B. VI-A, VI-B, VI-C (up to 15 percent alcohol), VII-B, and VIII under Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: Sep 21, 2011
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.26 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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