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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. 1101

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).
Notifier: Gruppo Mossi & Ghisolfi
Manufacturer: Gruppo Mossi & Ghisolfi
M&G Polymers USA, LLC
Intended Use: For use as a modifier in 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 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 resulting PET may be used in contact with food types III, IVA, IVB, V, VIIA, VIIB, VIII, and IX under Conditions of Use C through G, as described in Tables 1 and 2, and according to other applicable limitations/specifications as appropriate.
Effective Date: Aug 30, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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