Companies exporting virtually any product to the European Union must know if their goods have PFAS and weigh in on the region’s new proposed phaseout of those chemicals, which could greatly affect many US companies, attorneys said.
The potential breadth of the restriction that the European Chemical Agency (ECHA) proposed on Feb. 7 is “staggering,” said Lawrence Culleen, a partner with Arnold & Porter Kaye Scholer LLP who specializes in chemical regulations.
The proposed requirements could affect the production and distribution of chemicals, mixtures of chemicals, and manufactured products, he said.
Affected business may need to reexamine the composition and design of thousands of products ranging from camping gear to more complex articles such as mobile phones, computers, automobiles, wind turbines, and more, Culleen said.
The restriction would have “enormous impact on any company doing business in or with the EU,” said John Gardella, who chairs CMBG3 Law LLC’s PFAS, Environmental, Risk Management & Consulting, and ESG practice groups.
A public meeting that ECHA will hold on April 5 to discuss its proposal “will be of critical importance” to US companies, Culleen said. ECHA is accepting public comments on its proposal for six months beginning March 22.
It’s essential to comment within the first month of the consultation beginning, said Ales Bartl, a partner specializing in chemical laws in Keller and Heckman LLP’s Brussels office.
Two committees whose opinions will help shape the final restrictions will pay attention to those initial comments, Bartl said during a webinar the law firm held on Tuesday about the proposed restriction. Additional comments can then be filed during the remaining consultation, he said.
The final restriction, expected in 2025, will likely be challenged in court, Bartl said. But the legal challenge wouldn’t suspend the restrictions, he said.
Europe’s proposed PFAS ban also is likely to spur more and broader US state bans and prompt additional PFAS-control legislation on Capitol Hill, said Herbert Estreicher, a partner in Keller and Heckman’s Washington office.
ECHA is proposing the ban as part of the European Union’s REACH, or Registration, Evaluation, Authorization and Restriction of Chemicals, regulation.
The ban would cover chemicals and mixtures, along with articles having 25 parts per billion (ppb) or more of particular PFAS or 250 ppb of a combination of PFAS. Total fluorine measurements, which indicate PFAS but don’t directly identify the chemicals, also can be used to trigger additional information and a possible ban.
PFAS would generally be phased out beginning 18 months after the rule is finalized. The bans would transition in through a range of derogations, or time periods, that would allow the chemicals to be phased out over periods of either five or 12 years.
PFAS in some products, like food packaging consumers use, would be banned even if their use is allowed under other regulations, Bartl said.
ECHA also seeks data for some uses of PFAS to decide whether and how long a phaseout period to offer, he said.
Companies that continue to make or use PFAS under a derogation would have to regularly report information such as the amount they place on the European market, Bartl said.
Per- and polyfluoroalkyl substances (PFAS) are widely used in many different industries, because they give products special elasticity, corrosion resistance, weather resistance, and other properties.
But most PFAS persist in the environment for years or decades, ECHA said. That persistence combined with the possibility that they may build up in the food chain, be harmful to people or the environment, and contribute to global warming justifies a broad restriction of the entire group,the European agency said.
“Consequently, if releases of PFASs are not minimised, humans and other organisms will be exposed to progressively increasing amounts of PFASs until such levels are reached where effects become inevitable. In such an event these exposures are practically irreversible as it is technically extremely difficult, if at all possible, to remove PFASs from the environment,” the proposal said.
ECHA defined PFAS broadly by their chemical structure to include thousands of chemicals. Only a few, such as trifluoromethanol, trifluoromethylamine, and difluoromethanediol, would be exempted, because they are unstable compounds that spontaneously decompose, according to one of the restriction’s many annexes.
Biocides, called pesticides in the US, along with human and veterinary medicines, also would be exempted from the restriction.
PFAS used in specialized fire fighting suppressants, called aqueous film-forming foam (AFFF) are being phased out through a separate restriction.
Companies and trade associations should pay close attention to brackets ECHA used to propose many phaseout periods, Culleen said. The brackets are ECHA’s way of saying it needs more information to decide how long the phaseout period should be, he said.
If the agency doesn’t receive needed information “no derogation will be proposed,” the rule said. That means the ban could apply immediately or that the time proposed for a phaseout could be revised.
Deadlines to eliminate PFAS in hernia meshes, certain contact lenses, coatings for metered dose inhalers, and packaging for sterilized medical devices are among the bracketed sections of ECHA’s rule, although the agency said it’s considering starting phaseouts 13 1/2 years after the restriction enters into force.
Companies, working through their trade associations, should take advantage of the multiple public comment opportunities ECHA and its committees will offer, reach out to the European Commission, and discuss concerns with member states, Bartl said.
Industries should request a 32-month instead of 18-month transition period to prepare for the phaseouts, seek additional derogations, and comment on situations where alternative chemicals aren’t available, he said. “There’s a need for solid data” on issues including risks PFAS may not pose and socioeconomic impacts of the bans, Bartl said.
The American Chemistry Council, which represents chemical manufacturers, said it needed a few weeks to digest ECHA’s 1,981-page proposal and discuss it with member companies. The council expects to work with other trade associations, including ones representing the many industries that rely on fluoropolymers, as it develops comments, said Shawn Swearingen, a director with the council who works on PFAS.
If finalized the proposal would be one of the broadest chemical restrictions ever enacted, and one that would treat all the chemicals similar despite significant differences, the council said by email.
Solvay, a multinational chemical company based in Belgium, is developing ways to make fluoropolymers without PFAS production aids, said Peter Boelaert, a Solvay spokesman. Production aids can more easily get into the environment than fluoropolymers.
ECHA’s restriction would have tremendous impacts on the market, said Sarah Doll, national director for Safer States, which tracks state chemical legislation. It’s valuable for an entire international region to be proposing controls that amplify what individual US states like California, Maine, and Colorado have done by banning PFAS in textiles and other products, she said.
—With assistance from Stephen Gardner.
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