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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. 847

Indorama Ventures USA Inc. and its stewarded affiliates around the world
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: Nylon MXD-6 (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) meeting the analytical specifications in 21 CFR 177.1500(b), item 10.2 and used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0).
Notifier: Indorama Ventures USA Inc. and its stewarded affiliates around the world
Mitsubishi Gas Chemical Company, Inc.
Manufacturer: Indorama Ventures USA Inc. and its stewarded affiliates around the world
Mitsubishi Gas Chemical Company, Inc.
Intended Use: The FCS will be used as a modifier for polyethylene terephthalate copolyesters as described in Food-Contact Notification No. 72 and Food-Contact Notification No. 498.
Limitations/Specifications*: The FCS is intended for use at levels up to 5 weight percent by weight of the finished food-contact article, in conjunction with up to 0.015 weight percent cobalt stearate (measured as cobalt) of the finished food-contact article, in contact with Food Types I, II, IV-B, VI-A, VI-B, and VI-C (up to 15 percent alcohol), VII-B and VIII, except for carbonated soft drinks, as described in Sections 176.170(c), Table 1, under Conditions of Use C through G, as described in Table 2.
Effective Date: Dec 16, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32 (i) and (j)
FDA Decision: Categorical Exclusion Memo
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