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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. 1157

Mitsubishi Rayon 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: Poly(N-vinylformamide), 10-90 percent hydrolyzed hydrochloride salts. The FCS is specifically known as one of the following:
a) formamide, N-ethenyl-, polymer with ethanamine, hydrochloride (CAS Reg. No. 111616-55-8) or
b) formamide, ethenyl-, homopolymer, hydrolyzed, hydrochlorides (CAS Reg. No. 183815-54-5).
Notifier: Mitsubishi Rayon America, Inc.
Manufacturer: Mitsubishi Rayon Company, Ltd.
Intended Use: For use only as strengthening agents, fixing agents, or retention aids prior to the sheetforming operation in the manufacture of paper and paperboard.
Limitations/Specifications*: The FCS will be used at a level not to exceed 1.5 percent resin by weight of the finished dry paper or paperboard.
Effective Date: May 16, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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