Article by Pat Rizzuto (Bloomberg Law)
“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.
ECHA’s Feb. 7 proposed 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.
The restrictions generally would begin about 18 months after the rule is finalized—expected in 2025. 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.
But many other deadlines apply to different types of PFAS and uses of them. For example, certain PFAS that help produce fluoropolymers, large, bulky molecules that are used to coat and protect many types of equipment, textiles, and other goods, wouldn’t begin to be phased out until 6 1/2 years after the restriction enters into force.
PFAS used in highly specialized industrial cleaning fluids and a many refrigerants wouldn’t begin to be phased out until 13 1/2 years after the restriction enters into force.
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 as part of the REACH, or Registration, Evaluation, Authorization and Restriction of Chemicals, regulation, 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,’ said the proposal.
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.
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.
Hugo Vincent Duran, a spokesman for Plastics Europe and its Fluoropolymers Product Group, told Bloomberg Law on Feb. 7 that the group stands by an open letter released last month in which the two groups joined 21 automobile, motorcycle, and other trade associations asked for fluoropolymers to be exempted from the restriction.
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.”