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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. 817

Far Eastern New Century Corporation APG Polytech 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, and used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2).
Notifier: Gruppo Mossi & Ghisolfi
Manufacturer/Supplier: Far Eastern New Century Corporation APG Polytech LLC
Intended Use: The FCS will be used as a modifier of ethylene phthalate polymers regulated under 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN, including those modified with 1,3-benzenedicarboxylic acid, 5-sulfo-, monolithium salt according to FCN 546.
Limitations/Specifications: The FCS will be used at a level up to 5 weight percent of the finished food-contact article in conjunction with up to 0.015 weight percent cobalt neodecanoate (measured as cobalt) of the finished food-contact article. The modified polymers may be used in the manufacture of containers for contact with food types I, II, VI-A, VI-B, and VI-C (alcohol content up to 15 percent), except for carbonated soft drinks and water, under Conditions of Use C through G as described in Tables 1 and 2.
Effective Date: Jul 29, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo