FDA Removes Clearance for the Use of PFCs in Food Packaging Based on Abandonment
The U.S. Food and Drug Administration (FDA) has amended the food additive regulations to no longer authorize the use of two perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods based on the abandonment of these uses. The two PFCs are:
- 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; and
- 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.
This current action amends Title 21 of the Code of Federal Regulations (C.F.R.) Section 176.170 to no longer permit the use of the two substances listed above. FDA took this action in response to a petition submitted on behalf of 3M Corporation. In the petition, 3M stated that, to the best of its knowledge, it was the sole domestic and international manufacturer of the two substances, and that their use had been permanently abandoned by industry in the U.S. market. In a November 22, 2016 Federal Register notice, FDA emphasized that its action in amending this regulation is not based on a safety evaluation; rather, it is based on abandonment.