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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. 1012

Sanyo Chemical Industries, Ltd.
Toyotsu Chemiplas Corporation

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: Dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly(oxy-1,2-ethanediyl) and 1-propene (CAS Reg. No. 287916-86-3).
Notifier: Toyota Tsusho Corporation (TTC)
Manufacturer/Supplier: Sanyo Chemical Industries, Ltd.
Toyotsu Chemiplas Corporation
Intended Use: As an antistatic agent for polypropylene films in contact with all food types.
Limitations/Specifications: For use in a coextruded layered composition, in which one layer (no greater than 4 micron thickness) containing no more than 10 percent of the food contact substance, is no more than 20 percent of the total weight of the food contact composition. The concentration of the food contact substance in the finished food contact article is no greater than 2.0 percent. A food contact article containing the food contact substance may be used in contact with all food types under Conditions of Use B through G as described in Table 2.
Effective Date: Jan 13, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo