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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. 870

Mitsubishi Gas Chemical

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) meeting the specifications in 21 CFR 177.1500 (b), item 10.2, when tested by the methods given in 21 CFR 177.1500 (c).
Notifier: Mitsubishi Gas Chemical
Manufacturer: Mitsubishi Gas Chemical
Intended Use: As a modifier for polyethylene terephthalate (PET) polymers.
Limitations/Specifications*: (a) At levels not to exceed 30 percent by weight of the modified PET in contact with food types I, II, IV-B, VI-A, VI-B, VII-B and VIII and under Conditions of Use C through G, as described in Tables 1 and 2, respectively. Chloroform soluble extractives shall not exceed 0.08 mg/cm2 (0.5 mg/inch2) of food-contact surface of the modified PET article when exposed to water at 95°C (203°F) for 1 hour followed by 49°C (120°F) for 24 hours. (b) At levels not to exceed 10 percent by weight of the modified PET in contact with foods containing greater than 8 percent ethanol, food type VI-C, at temperatures not exceeding 71°C (160°F). Chloroform soluble extractives shall not exceed 0.08 mg/cm2 (0.5 mg/inch2) of food-contact surface of the modified PET article when exposed to 50 percent ethanol at 71°C (160°F) for 1 hour followed by 49°C (120°F) for 24 hours.
Effective Date: Apr 7, 2009
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (412 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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