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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. 34

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: Nylon 6/12 resins manufactured by the copolymerization of at least 80 weight percent of epsilon-caprolactam and no more than 20 weight percent of ω-aminododecanoic acid. (CAS Reg. No. 25191-04-2)
Notifier: UBE Industries, Ltd.
Manufacturer/Supplier: UBE Industries, Ltd.
Intended Use: For use in the manufacture of multilaminate packaging films and not for use in direct contact with food.
Limitations/Specifications: The finished resins may safely be used with: non-alcoholic foods at temperatures not to exceed 100°C (212°F); Laminate structures with authorized food-contact materials yield no more than 0.15 milligram of epsilon-caprolactam and 0.04 milligram for both ω-laurolactam and ω-aminododecanoic acid per square inch when extracted with water at 100°C (212°F) for 5 hours (complying with 177.1395).
Effective Date: May 21, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 556 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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