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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. 135

Indorama Ventures
Xylenes & PTA LLC

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: Dimethyl 2,6-naphthalenedicarboxylate (NDC, CAS Reg. No. 840-65-3) or 2,6-naphthalenedicarboxylic acid (NDA, CAS Reg. No. 1141-38-4).
Notifier: BP Amoco Chemical Company
Manufacturer/Supplier: Indorama Ventures
Xylenes & PTA LLC
Intended Use: As a chemically bound component in poly(ethylene terephthalate-isophthalate-2,6-naphthalate) (PET/I/N) copolymers. The PET/I/N copolymers will be used to manufacture articles or films intended for single serve or repeat use at temperatures up to and including Conditions of Use C through H as described in Table 2, in contact with food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII as defined in Table 1.
Limitations/Specifications*: The finished PET/I/N copolymers will incorporate not more than 2.5 mole percent (3.1 weight percent) of polymer units derived from ethylene 2,6-naphthalate.
Effective Date: May 30, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo