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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. 2039

Buckman Laboratories, 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: Diallyldimethylammonium chloride polymer with acrylamide (CAS Reg. No. 26590-05-6) produced by copolymerizing up to 5 weight percent of acrylamide and up to 95 weight percent of diallyldimethylammonium chloride.
Notifier: Buckman Laboratories, Inc.
Manufacturer/Supplier: Buckman Laboratories, Inc.
Intended Use: For use as a charge and pitch control aid, coagulant, or drainage aid to be added prior to the sheet forming process in the manufacture of food contact paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS should not exceed 3 kg/short 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 (21 CFR 176.170(c)), respectively. 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: Jun 20, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo