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Authorization for Food Contact Use of Two Substances Proposed to be Withdrawn

Friday, April 29, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting comments through June 28 on a petition to withdraw authorization for the use of the following perfluoroalkyl-containing substances as oil and water repellants for paper and paperboard in contact with aqueous and fatty foods because these uses have been intentionally and permanently abandoned.

- ammonium bis (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, containing not more than 15 percent ammonium mono (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, where the alkyl group is more than 95 percent C8 and the salts have a fluorine content of 50.2 percent to 52.8 percent as determined on a solids basis

- perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265-81-1) containing 35 to 40 weight percent fluorine, produced by the copolymerization of ethanaminium, N,N,Ntrimethyl-2-[(2-methyl-1-oxo-2-propenyl)-oxy]-, chloride; 2-propenoic acid, 2-methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl ester; and 2-propenoic acid, 2[[(heptadecafluoro-octyl)sulfonyl]methyl amino]ethyl ester

The petitioner said it believes it was the sole and exclusive domestic and international manufacturer of these two substances for the abandoned uses, that it does not currently manufacture them for food contact use in the U.S., and that it does not intend to manufacture or import, nor does it maintain an inventory for sale or distribution of, these substances for use in food contact applications in the U.S. in the future.

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