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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. 1077

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: 2,5-Furandione, polymer with 1,3-butadiene (CAS Reg. No. 25655-35-0).
Notifier: Gruppo Mossi & Ghisolfi
Manufacturer: Gruppo Mossi & Ghisolfi
M&G Polymers USA, LLC
Intended Use: For use as a modifier in polyethylene terephthalate (PET) polymers complying with 21 CFR 177.1630 and ethylene phthalate polymers that are the subject of an effective FCN.
Limitations/Specifications*: The FCS may be used in PET such that the 2,5-furandione, polymer with 1,3-butadiene is present at a level not to exceed 0.11 weight-percent reacted with hexanedioic acid, polymer with 1,3-benzenedimethylamine (meeting with the analytical specifications set forth in 21 CFR 177.1500(b) item 10.2) present at a level not to exceed 4.89 weight-percent in conjunction with cobalt neodecanoate present at a level not to exceed 0.015 weight-percent (measured as cobalt). The resulting PET may be used in contact with all food types (or according to other applicable limitations/specifications as appropriate) except for carbonated soft drinks and water, under Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: Aug 9, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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