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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. 1135

Mitsubishi Gas Chemical Company, 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: 1,4-benzenedicarboxylic acid, polymer with 1,2-ethanediol and β,β,β',β',-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS Reg. No. 102070-64-4).
Notifier: Mitsubishi Gas Chemical Company, Inc.
Manufacturer: Mitsubishi Gas Chemical Company, Inc.
Intended Use: As the basic polymer in the manufacture of films, coatings, and molded articles having a maximum thickness of 5 mm for single-use and repeated-use food-contact applications.
Limitations/Specifications*: The FCS may be used (a) in contact with all food types under Conditions of Use C through G as set forth in Tables 1 and 2. Where the spiro glycol content constitutes < 30 mol% total glycol units in the polyester; and (b) in contact with all food types under Conditions of Use B through H as set forth in Tables 1 and 2, where the spiro glycol content constitutes between 30 mol% to 50 mol% total glycol units in the polyester.
Effective Date: Apr 20, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (34 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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