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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. 2050

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: Copolymer of acrylamide, 2-methacryloxyethyltrimethylammonium chloride, itaconic acid, and N,N'-methylenebis(acrylamide) (CAS Reg. No. 214495-32-6).
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, as a retention and/or drainage aid added prior to the sheet forming process in the manufacture of paper and paperboard, 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, intended to contact food, including powdered infant formula (see Limitations/ Specifications).
Limitations/Specifications: The FCS should not exceed 30 lbs/ton dry weight of the finished paper and paperboard in food-contact paper and paperboard. The FCS may be used in contact with all types of food, including powdered infant formula under Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Jun 17, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 681 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 105 kB)

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