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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. 2181

Mitsubishi Gas Chemical Co., 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: 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (CAS Reg. No. 28628-75-3).
Notifier: Mitsubishi Gas Chemical Co., Inc.
Manufacturer/Supplier: Mitsubishi Gas Chemical Co., Inc.
Intended Use: As the non-food-contact layer in applications in which the food-contact layer is a polymer authorized for the intended use, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: Multilayer structures containing the FCS may be used in contact with all foods, except those containing more than 15 percent alcohol, under Conditions of Use A through H, as described in Tables 1 and 2. The FCS may contain 10-55 mole percent of isophthalic acid-1,3-benzenedimethanamine polymer units. The non-food-contact layer of the FCS will be separated from food by an adhesive tie layer having a thickness of no less than 5 µm and a food-contact layer having a thickness of no less than 25 µm. The food contact layer may consist of polypropylene homopolymer or any authorized polymer with equivalent or better barrier properties. The FCS is not for use in contact with infant formula or human milk. Such uses were not a part of the intended use of the substance in the FCN.
Effective Date: Mar 23, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 822 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 179 kB)

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