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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. 1592

Plasmine Technology, Inc./Harima Chemicals, 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
Notifier: Plasmine Technology, Inc./Harima Chemicals, Inc.
Manufacturer: Plasmine Technology, Inc./Harima Chemicals, Inc.
Intended Use: For use as a wet and dry strength agent added prior to the sheet forming process in the manufacture of paper and paperboard at levels up to 30 pounds per ton by dry weight of the finished paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations and Specifications).
Limitations/Specifications*: The FCS may be used in contact with all types of food in applications for which the FCS is technically suitable 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 breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 9, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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