Two were withdrawn by BASF Corporation and E. I. DuPont de Nemours & Co and Clariant withdrew one substance, with the graseproofing agents expected to be out of the markerplace within a year.
Perfluorinated greaseproofing agents are coatings on paper wrappers, paperboard and containers that come into contact with food.
Removed from market
In a document to manufacturers the FDA said: “FDA’s assessment of the available data on these types of compounds has indicated the need to consider factors in addition to those traditionally considered by the Agency at similar exposure levels.
“These include additional possible toxic endpoints (e.g., effects on pre- and post-natal development and reproductive health and function), perfluorinated carbon chain lengths, and appropriate animal models.
“…consumer exposure to the FCS is expected to rapidly decrease, and FDA estimates that little to no additional exposure will occur one year after the cessation of initial introduction.”
The FDA said it will conduct a market survey of food packaging to ensure that these compounds are no longer used in material that comes in contact with human or animal food.
Substance description
BASF Corporation withdrew “3-cyclohexene-1-carboxylic acid, 6-[(di-2-propenylamino) carbonyl]-, sodium salt, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, ammonium salts (CAS Reg. No. 392286-82-7)” and “Glycine, N,N-bis[2-hydroxy-3-(2-propenyloxy)propyl]-, monosodium salt, reaction products with ammonium hydroxide and pentafluoroiodoethane-tetrafluoroethylene telomer (CAS Reg. No. 220459-70-1)”.
E.I. DuPont de Nemours & Co will no longer sell “Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 247047-61-6)” and “Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid (CAS Reg. No. 870465-08-0)”
Clariant agreed to withdraw “Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate (CAS Reg. No. 479029-28-2)”.
Following recent studies the FDA raised safety concerns with one type of perfluorinated chemicals, known as C8 compounds, and initiated a comprehensive review of the available data.
