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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. 182

BASF AG/BASF 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: Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared by reacting hexanedioic acid, 1,2-ethanediamine, N-(2-aminoethyl)-1,3-propanediamine, N,N''-1,2-ethanediylbis-1,3-propanediamine, (chloromethyl)oxirane, ethyleneimine(aziridine), and polyethylene glycol, and partly neutralized with sulfuric acid (CAS Reg. No. 167678-43-5) or formic acid (CAS Reg. No. 114133-44-7).
Notifier: BASF Corporation
Manufacturer: BASF AG/BASF Corporation
Intended Use: For use as a retention aid employed prior to the sheet-forming operation in the manufacture of paper and paperboard.
Limitations/Specifications*: For use at a level not to exceed 0.12 percent resin by weight of the finished dry paper or paperboard.
Effective Date: Jan 17, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo