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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. 2127

Mitsubishi Engineering-Plastics 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: Poly(tetramethylene terephthalate)(CAS Reg. No. 24968-12-5 and 26062-94-2) as manufactured from terephthalic acid and 1,4-butanediol.
Notifier: Mitsubishi Engineering-Plastics Corporation
Manufacturer/Supplier: Mitsubishi Engineering-Plastics Corporation
Intended Use: For use as a base polymer used in the manufacture of single- and repeat-use food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is for use 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: Jun 5, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 233 kB)
FDA Decision: Finding of No Significant Impact (FONSI) & EA Revision Sheet (in PDF, 134 kB)

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