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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. 1099


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: 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate, and poly(oxy-1,2-ethanediyl), α-(2-methyl-1-oxo-2-propenyl)-ω-hydroxy-, C16-18-alkyl ether.
Notifier: BASF SE
Manufacturer/Supplier: BASF SE
Intended Use: Used as a thickener in clay and calcium carbonate coatings applied to paper and paperboard.
Limitations/Specifications: The maximum use level of the FCS in clay and calcium carbonate coatings is 0.4 percent by weight of the dry coating. Coatings containing the FCS may contact with all food types under Conditions of Use C through G, as described in Table 2.
Effective Date: Aug 30, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo