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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. 1841

Mitsubishi Gas Chemical Company, Inc.
MGC Advanced Polymers, 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: Hexanedioic acid polymer with 1,3-benzenedimethanamine (CAS Reg. No. 25718-70-1).
Notifier: Mitsubishi Gas Chemical Company, Inc.
Manufacturer/Supplier: Mitsubishi Gas Chemical Company, Inc.
MGC Advanced Polymers, Inc.
Intended Use: As the basic polymer in the manufacture of articles intended to contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: Articles containing the FCS may be used in contact with all types of food under Conditions of Use A through H, as described in Tables 1 and 2, respectively. The FCS may contain optional adjuvants permitted for use in nylon resins complying with 21 CFR 177.1500, subject to the prescribed limitations and specifications in the authorizing regulation or notification. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 23, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 254 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 105 kB)

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