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Food Contact Use of Two Substances No Longer Authorized

Tuesday, November 22, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a final rule amending the food additive regulations to withdraw authorization for the use of the following two perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods, effective Nov. 22.  

- 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,N-trimethyl-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 FDA explains that the described uses for these substances have been intentionally and permanently abandoned. 

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