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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. 1672

SEIKO PMC 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: Benzenemethanaminium, N,N-dimethyl-N-[2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl]-, chloride (1:1), polymer with 2-(dimethylamino)ethyl 2-methyl-2-propenoate, N,N-dimethyl-N-[2-[(1-oxo-2-propen-1-yl)oxy]ethyl]benzenemethanaminium chloride (1:1), 2-methylenebutanedioic acid, 2-propenamide and N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethanaminium chloride (1:1), cross-linked with dialkylacrylamide and alkylenebisacrylamide, as identified in the notification.
Notifier: SEIKO PMC Corporation
Manufacturer/Supplier: SEIKO PMC Corporation
Intended Use: The FCS is intended for use as a dry strength agent added prior to the sheet forming process in the manufacture of paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is for use at levels not to exceed 0.5% by dry weight of the finished paper and paperboard in contact with all food types under Conditions of Use A through H and J as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 31, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo