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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. 1553

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: 2-Propen-1-aminium, N,N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with ethanedial and 2-propenamide (CAS Reg. No. 32555-39-8).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As a dry- and wet-strength agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard in contact with all food types, except for use in infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at levels not to exceed 1.0 percent by weight of the dry fibers in the finished paper and paperboard. The finished articles may be used under Conditions of Use A through H. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 9, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 8.3 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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