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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. 1976

Arakawa Chemical Industries, Ltd.

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: Copolymers of acrylamide, 2-(dimethylamino)ethyl methacrylate, itaconic acid, benzyl[2-(methacryloyloxy)ethyl](dimethyl)ammonium chloride, and benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride, optionally crosslinked with hexahydro-1,3,5-tris(1-oxoallyl)-1,3,5-triazine.
Notifier: Arakawa Chemical Industries, Ltd.
Manufacturer/Supplier: Arakawa Chemical Industries, Ltd.
Intended Use: 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 may be used 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: May 31, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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