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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. 902

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 (CAS Reg. No. 25718-70-1) (also known as hexanedioic acid, polymer with 1,3-benzenedimethanamine) meeting the analytical specifications in 21 CFR 177.1500(b) item 10.1 and used in conjunction with either cobalt stearate (CAS Reg. No. 13586-84-0) or cobalt acetate (CAS Reg. No. 71-48-7).
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 of polyethylene terephthalate copolyesters described in FCN 72 and FCN 498.
Limitations/Specifications*: Nylon MXD-6 may be used at a level not to exceed 5 weight percent of the finished food-contact article in conjunction with either cobalt stearate or cobalt acetate used at a level not to exceed 0.015 weight percent (measured as cobalt) of the finished food-contact article. The finished food contact article may be used in contact with food types I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol), VII-B, and VIII, except for carbonated soft drinks, under Conditions of Use C through G.
Effective Date: Sep 9, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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