On November 22, 2016 the U.S. Food and Drug Administration (FDA) issued a final rule prohibiting the use of “two specific perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods.”
The two substances are: 1) Ammonium bis (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, containing not more than 15% ammonium mono (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, where the alkyl group is more than 95% C8 and the salts have a fluorine content of 50.2% to 52.8% as determined on a solids basis; and 2) perfluoroalkyl acrylate copolymer (CAS 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.
This final rule was issued in response to a petition filed by Keller and Heckman LLP on behalf of chemical company 3M in April 2016. The petition asked the FDA to amend the food additive regulations and no longer provide for the use of the two substances “because these uses have been intentionally and permanently abandoned.” In 1968, 1970, 1972, and 1987 3M submitted several petitions to the FDA, who authorized certain uses of both perfluorinated compounds under 21 CFR 176.170.
Already in January 2016, the FDA published a final rule prohibiting the use of three perfluorinated substances as oil and water repellents for paper and paperboard in contact with food (FPF reported). The rule came in response to a petition filed by nine public interested groups in January 2015 (FPF reported).
Federal Register (November 22, 2016). “Indirect food additives: Paper and paperboard components.”
Kelly Franklin (November 22, 2016). “US FDA revokes food contact authorisation for two PFCs.” Chemical Watch