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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. 1354

UBE Engineering Plastics S.A.
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 hexahydro-2H-azepin-2-one and 1,6-hexanediamine [Nylon 6/66] (CAS Reg. No. 24993-04-2).
Notifier: UBE Corporation Europe S.A.
Manufacturer/Supplier: UBE Engineering Plastics S.A.
UBE Industries, Ltd.
Intended Use: As a component of films intended to contact food.
Limitations/Specifications: The FCS may be used in contact with all food types under Conditions of Use A through H and J (for dual-ovenable containers), as described in Tables 1 and 2. The films will have a maximum thickness of 1 mi (0.001 inch) of the FCS. The FCS may be used in cook-inbag/packaging film applications and in multi-layer film applications at temperatures up to 375°F for 4 hours. Adjuvant substances permitted for use in Nylon 6/66 polymers may be used in the copolymer, subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation or notification.
Effective Date: Feb 19, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 841 kB)
FDA Decision: Finding of No Significant Impact (FONSI)