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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. 839

Sanyo Chemical 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: 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
Manufacturer: Sanyo Chemical Industries, Ltd.
Intended Use: As an antistatic agent in polymer films, compliant with existing authorizations.
Limitations/Specifications*: For use at levels not to exceed 20 weight percent of the finished article in contact with non-fatty, dry foods (i.e., Food Type VIII) under Conditions of Use E through G, as described in Tables 1 and 2.
Effective Date: Nov 21, 2008
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (132 kB)
FDA Decision: Finding of No Significant Impact (FONSI)