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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. 919

Lion Copolymer, LLC

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-propylene-ethylidene norbornene-dicyclopentadiene elastomer
Notifier: Lion Copolymer, LLC
Manufacturer/Supplier: Lion Copolymer, LLC
Intended Use: For use in rubber articles intended for repeat use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food.
Limitations/Specifications: The FCS shall contain no more than 5 weight-percent of total polymer units derived from 5-ethylidene-2-norbornene and no more than 0.8 weight-percent of polymer units derived from dicyclopentadiene. The FCS may be used subject to the provisions of 21 CFR 177.2600(c)(4)(i) and must meet the specifications in 177.2600, paragraphs (b) and (d) through (g).
Effective Date: Dec 16, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo