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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. 665

Gruppo Mossi & Ghisolfi M&G Polymers USA 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: Hexanedioic acid, polymer with 1,3-benzenedimethanamine (CAS Reg No. 25718-70-1), meeting the analytical specifications in 21 CFR 177.1500(b) item 10.2, when tested by the method given in 21 CFR 177.1500(d).
Notifier: Gruppo Mossi & Ghisolfi
Manufacturer: Gruppo Mossi & Ghisolfi M&G Polymers USA LLC
Intended Use: For use as a modifier of ethylene phthalate polymers complying with 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN.
Limitations/Specifications*: The FCS will be used at a level not to exceed 5 weight percent of the finished food-contact article. The modified polymer may be used to manufacture wine containers for use under the Conditions of Use C through G and in contact with Food Types VI-C (alcohol content to 15 percent) as described in Tables 1 and 2.
Effective Date: Jan 10, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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