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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. 1146

Indorama Ventures USA LLC and its Steward Affiliates Around the World

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) (CAS Reg. No.25718-70-1) meeting the analytical specifications in 21 CFR 177.1500(b), item 10.2.
Notifier: INVISTA Resins & Fibers GmbH
Manufacturer/Supplier: Indorama Ventures USA LLC and its Steward Affiliates Around the World
Intended Use: The FCS will be used as a modifier for polyethylene terephthalate (PET), including copolyesters.
Limitations/Specifications: The FCS may be used at levels up to 5 percent by weight of the finished food contact article, for use in contact with Food Types I, II, IV-B, VI-A, VI-B, VI-C (up to 15% alcohol), VII-B, and VIII under Conditions of Use C through G as described in Tables 1 and 2.
Effective Date: Apr 7, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo