In its presentation when the proposed restriction of PFAS was announced earlier this year, the ECHA said the definition of PFAS was based on its chemical structure.
It said the "forever chemicals" — as they are known because they stay in the environment for years — are known for their persistence, and that potentially leads to harmful effects in humans and in the environment.
There are an estimated 230,000 metric tons of PFAS placed on the market every year, according to the ECHA, and there are some PFASs that were found to be carcinogens or cause harm to unborn children and have a detrimental effect on organs. PFOA and PFOS, for example, are no longer produced in the U.S.
The authors of the proposed restriction, which is in the comment stage until Sept. 25, said the measure was made purposely broad for a number of reasons, including that PFAS can be found almost everywhere.
"There are concerns growing about the whole group of PFAS, not just those on which we have good knowledge," a presenter said when the measure was unveiled. "... With this restriction we are putting forward, we want to address the problem on a large scale. We think it's way more efficient to do this in a group approach. Address it all now in one go, rather than the prior ones that were done one by one."
Those in the rubber industry who are making or using FKMs and other fluoropolymers disagree with this assessment.
The nonpolymers have ended up in drinking water, said Phil Mahoney, director of engineering services for sealing device firm A.W. Chesterton and chair of government affairs and the PFAS task force for the Fluid Sealing Association.
"The fluoropolymers and fluoroelastomers are regarded as safe," he said. "They are large molecules. They don't pass through cell membranes. They are 'forever chemicals' in the sense they all are, because it's hard to break that carbon-fluorine bond.
"... The problem is society is hearing about PFAS, and assuming that all of these are bad. Our argument is we have data to show that these are not the problems," he said.
Mahoney didn't pull any punches in calling the ECHA's proposal to ban all PFAS as "ludicrous."
And A.W. Chesterton — who also does business in Europe — says it has a vested interest in how that measure progresses.
"There are other chemicals we use in processing like benzene, chlorine, other dangerous materials," he said. "They are not biopersistent, but the point being that they are dangerous and we do regulate those."
William Heslip, regulatory compliance stewardship manager for Freudenberg-NOK Sealing Technology, said most industry associations from the U.S. and Europe are pushing back hard in the broad approach taken with the proposed PFAS ban, which is proceeding under the EU's REACH Regulation. During the April webinar, one person asked why there was no separation between polymeric and non-polymeric PFAS.
"In that instance, they said they are aware of these concerns, but to them the polymers, even though they don't migrate or pose as high of a risk from a health hazard or environmental hazard standpoint, they still last a very long time," Heslip said. "So they still wanted them on the restriction list because of that.
"They aren't the ones who make the final decision, but they are the ones who brought forth the issue and are trying to have it turn into law. If it went through as proposed, the impact would be immeasurable."
As the ECHA proposal takes its slow slog through the regulatory process, it is imperative that those in the FKM and fluoropolymer sector remind those considering the ban that it really is a question of definition, according to Konrad Saur, Trelleborg Sealing Solutions vice president of innovation and technology.
The restriction proposal is painting everything that has a fully fluorinated carbon, including fluorocarbons, with the same broad brush. But he said FKMs are inert and are used in highly demanding applications that involve extreme temperatures, high pressure and aggressive media because they don't degrade.
"I think we have to be very frank, that some of these lower molecular weight PFASs are really worrying substances," Saur said. "There is evidence that they have adverse environmental effects. There is scientific research that suggest evidence of adverse human health impacts. We should not negate that.
"But we should not draw the umbrella too big, because really, chemically we're talking about different profiles of chemicals."