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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. 1797

Harima Chemicals, Inc.
Plasmine Technology, Inc.

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, diallyldimethylammonium chloride, 2-methylenebutanedioic acid and propenoic acid. REPLACES FCN 1592
Notifier: Harima Chemicals, Inc.
Plasmine Technology, Inc.
Manufacturer/Supplier: Harima Chemicals, Inc.
Plasmine Technology, Inc.
Intended Use: For use as a wet and dry strength agent, retention and/or drainage aid to be added prior to the sheet forming process, and as a pitch control agent added prior to the sheet forming process/or to pulp in the pulping process immediately prior to sheet forming in the manufacture of paper and paperboard, except for use in contact with infant formula and human milk (see Limitations and Specifications).
Limitations/Specifications: The FCS should not exceed 30 pounds per ton by dry weight of the finished paper and paperboard. The FCS may be used in contact with all types of food under Conditions of Use A through H, as described in Tables 1 and 2, respectively. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 30, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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