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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. 405

TOPAS Advanced Polymers GmbH
Polyplastics USA, Inc., and
Polyplastics Co., Ltd.

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: Ethylene-2-norbornene copolymer (CAS Reg. No. 26007-43-2). The CAS nomenclature is bicyclo{2.2.1} hept-2-ene, polymer with ethene.
Notifier: TOPAS Advanced Polymers, Inc. and TOPAS Advanced Polymers GmbH
Manufacturer/Supplier: TOPAS Advanced Polymers GmbH
Polyplastics USA, Inc., and
Polyplastics Co., Ltd.
Intended Use: As a basic polymer used in the production of articles intended to contact food.
Limitations/Specifications: Ethylene-2-norbornene copolymer (density 1.02+0.04 g/cm3) may contain not less than 20 but no more than 70 mole percent of polymer units derived from norbornene in contact with all food types under conditions of use A through H.
Effective Date: May 20, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 507 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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