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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. 1599

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: 1-Propanaminium, N,N,N-trimethyl-3-[(1-oxo-2-propen-1-yl)amino]-, chloride (1:1), polymer with ethenamine and 2-propenamide, hydrochloride (CAS Reg. No. 1659307-53-5).
Notifier: Solenis LLC
Manufacturer/Supplier: Solenis LLC
Intended Use: As a dry strength agent employed prior to the sheet-forming operation in the manufacture of uncoated paper that will be used in contact with all food types, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a level not to exceed 0.4 weight percent of the finished paper on a dry basis. 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: Jan 6, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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