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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. 75

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: 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: TOPAS Advanced Polymers, Inc. and TOPAS Advanced Polymers GmbH
Intended Use: To manufacture films, sheets, and articles made therefrom for food-contact applications; not for use in making bottles.
Limitations/Specifications*: Ethylene-2-norbornene copolymer (density 1.02+0.04 g/cm3) may contain not less than 30 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. Manufacture, purification and specifications as described in this notification.
Effective Date: Aug 22, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (538 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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