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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. 1008

Toyobo Company, 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: Cyclohexylamine (CAS Reg. No. 108-91-8).
Notifier: Toyobo Company, Ltd.
Manufacturer: Toyobo Company, Ltd.
Intended Use: As a chain-terminating agent used in the manufacture of Nylon 6.
Limitations/Specifications*: The FCS may be used at a level not to exceed 0.1 weight percent of finished Nylon 6 film. Finished Nylon 6 film manufactured with the FCS may not exceed 25 μm (1 mil) thickness for use in contact with all foods under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Oct 8, 2010
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (195 kB)
FDA Decision: Finding of No Significant Impact (FONSI)