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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. 769

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: N,N'-bis(phenylmethyl)hexanediamide (CAS Reg. No. 25344-24-5) used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2).
Notifier: Plastipak Packaging, Inc.
Manufacturer: Plastipak Packaging, Inc.
Intended Use: As a modifier of ethylene phthalate/naphthalate polymers and copolymers excluding those modified with organic anhydrides.
Limitations/Specifications*: The FCS 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 0.0075 weight percent (measured as cobalt) of the finished food contact article. Finished food-contact articles containing the FCS may be used in the manufacture of containers for contact with food types I, II, VI-A (alcohol content up to 15 percent) and VI-B, except carbonated beverages and water, under Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: Jan 15, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo