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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. 628

Clariant Corporation

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: Introduction into interstate commerce and delivery for introduction into interstate commerce voluntarily ceased by the manufacturer
Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate (CAS Reg. No. 479029-28-2).
Notifier: Clariant Corporation
Manufacturer: Clariant Corporation
Intended Use: For use as an oil and grease repellent in the manufacture of paper and paperboard.
Limitations/Specifications*: Introduction into interstate commerce and delivery for introduction into interstate commerce voluntarily ceased by the manufacturer
The FCS may be added during the paper making process: (1) to the pulp slurry (wet-end) at a level not to exceed 0.5 weight percent of dry, finished paper, for use in contact with food under Conditions of Use A through H, as described in Table 2 or (2) at the size press at a level not to exceed 0.7 weight percent of dry, finished paper, for use in contact with food under Conditions of Use C through G, as described in Table 2.
Effective Date: Oct 10, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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