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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. 849

Plastipak Packaging, 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 cobalt neodecanoate (CAS Reg. No. 27253-31-2).
Notifier: Plastipak Packaging, Inc.
Manufacturer/Supplier: Plastipak Packaging, Inc.
Intended Use: The FCS will be used as a modifier of ethylene phthalate/naphthalate polymers and copolymers, excluding those modified with organic anhydrides.
Limitations/Specifications: Nylon MXD-6 will be used at a level not to exceed 3 weight percent of the finished food-contact article in conjunction with cobalt neodecanoate used at a level not to exceed 0.02 weight percent (measured as Cobalt) of the finished food-contact article. The modified polymers may be used in the manufacture of containers for contact with food types I, II, IV-B, VI-A, and VI-B as described in Table 1, except for carbonated soft drinks and water, under use conditions C through G as described in Table 2
Effective Date: Feb 27, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo