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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. 1068

Unitika, 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: Fatty acids, coco, sesquiesters with polyethylene glycol (CAS Reg. No. 61791-04-6).
Notifier: Unitika, LTD
Manufacturer/Supplier: Unitika, LTD
Intended Use: An antistatic agent for use in the manufacture of Nylon 6 film.
Limitations/Specifications: The FCS may be used at a level not to exceed 0.04 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: May 11, 2011
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 127 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement

*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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