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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. 778

Coatex S.A.S., Coatex Inc., Coatex B.V.

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 α-(2-methyl-1-oxo-2-propenyl)-ω-methoxypoly(oxy-1,2-ethanediyl) and 2-propenoic acid, graft, sodium salt (CAS Reg. No. 381686-36-8).
Notifier: Coatex S.A.S.
Manufacturer/Supplier: Coatex S.A.S., Coatex Inc., Coatex B.V.
Intended Use: For use as an adjuvant for coatings applied to food-contact paper and paperboard, as described in the notification.
Limitations/Specifications: The FCS may be used at levels not to exceed 167 ug/in2 of the finished paper and paperboard. The finished paper and paperboard may contact all food types under Conditions of Use C through G as described in Table 2.
Effective Date: Feb 22, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo