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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. 1163

PolyOne Corporation
Nanocor® 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: Montmorillonite (CAS Reg. No.1318-93-0) surface treated with quaternary ammonium compounds bis(hydrogenated tallow alkyl)dimethyl, chlorides (CAS Reg. No. 61789-80-8).
Notifier: PolyOne Corporation
Nanocor® Inc.
Manufacturer: PolyOne Corporation
Nanocor® Inc.
Intended Use: As a peelable sealing structure in food-contact films.
Limitations/Specifications*: For use at levels not to exceed 15 wt-% in polymeric films, and the film layers containing the FCS has a thickness not to exceed 2 mils. The finished article may contact all food types under Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: May 29, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (1.9 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
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