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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. 1085

UBE Industries, Ltd.

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: Hexanedioic acid, polymer with 12-aminododecanoic acid, hexahydro-2H-azepin-2-one, and 1,6-hexanediamine (CAS Reg. No. 40959-29-3).
Notifier: UBE America, Inc.
Manufacturer/Supplier: UBE Industries, Ltd.
Intended Use: As a component of multi-layer laminate food-contact articles used in contact with all types of food.
Limitations/Specifications: The FCS will be used without limitation on use level or thickness, in non food-contact layers of multilayer films for various single- and repeated-use food-contact applications. The FCS will be separated from food by a polymer layer without limitation on thickness. The FCS will be a component of articles in contact with all foods under Conditions of Use B through H, as described in Table 2. Adjuvant substances permitted for use in nylon polymers complying with 21 CFR 177.1500 may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.
Effective Date: Jul 7, 2011
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 686 kB)
FDA Decision: Finding of No Significant Impact (FONSI)