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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. 566

Solenis LLC

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), 20-100 percent hydrolyzed, chloride or sulfate salts. The FCS is specifically known as one of the following: 1. formamide, N-ethenyl-, polymer with ethanamine, hydrochloride (CAS Reg. No. 111616-55-8) 2. formamide, N-ethenyl-, polymer with ethanamine sulfate (CAS Reg. No. 117985-59-8) 3. formamide, ethenyl-, homopolymer, hydrolyzed, hydrochlorides, (CAS Reg. No. 183815-54-5).
Notifier: Hercules Incorporated
Manufacturer/Supplier: Solenis LLC
Intended Use: As strengthening agents, fixing agents, or retention aids prior to the sheet-forming operation in the manufacture of paper and paperboard.
Limitations/Specifications: For use at a level not to exceed 1.5 percent by weight of the finished paper and paperboard.
Effective Date: Mar 15, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo