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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. 2135

Mitsubishi Chemical Corporation

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: 1,4-butanediol-polytetramethylene glycol-dimethyl terephthalate block copolymer (CAS Reg. No. 106465-17-2), reaction products with maleic anhydride.
Notifier: Mitsubishi Chemical Corporation
Manufacturer/Supplier: Mitsubishi Chemical Corporation
Intended Use: For use as an adhesive layer and as a food-contact heat seal layer in multilayer food packaging structures, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at a maximum thickness of 50 microns in contact with all food types under conditions of use A through H as described in Tables 1 and 2. The FCS is not intended 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: Sep 4, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 201 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 129 kB)

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