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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. 903

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: 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 in non food-contact layers separated from food by a polymer layer having a thickness of at least 20 micrometers (μm). For use as a component of articles in contact with all food under Conditions of Use B through H as described in Tables 1 and 2.
Effective Date: Sep 15, 2009
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (110 kB)
FDA Decision: Finding of No Significant Impact (FONSI)