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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. 871

Buckman Laboratories International, 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, reaction product with glyoxal, produced by copolymerizing from 20 to 90 weight percent of acrylamide and 10 to 80 weight percent of diallyldimethylammonium chloride, which is then cross-linked with not more than 30 weight percent of glyoxal.
Notifier: Buckman Laboratories International, Inc.
Manufacturer: Buckman Laboratories International, Inc.
Intended Use: As a dry and wet strength additive added prior to the sheet-forming operation in the manufacture of paper and paperboard at a level not to exceed 2% by weight of the dry fibers in the finished paper and paperboard.
Limitations/Specifications*: For use in contact with food types III, IV-A, V, VII-A, and IX and under Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Apr 9, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo