Perfluorinated chemicals voluntarily withdrawn due to safety concerns - FDA

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.

Two were withdrawn by BASF Corporation and E. I. DuPont de Nemours & Co and Clariant withdrew one substance, with the graseproofing agents expected to be out of the markerplace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)”.

FoodProductionDaily.com reported in May on an independent science panel finding a “probable link​” to kidney and testicular cancer associated to C-8P or perfluorooctanoic acid (PFOA) which had been emitted into the air and water supply from a DuPont plant in West Virginia.