The deadline for adding public commentary or requesting exemptions to proposed restrictions around PFAS in the EU is coming to a close on September 25, 2023.
Earlier this year, five national authorities submitted a proposal to the European Chemicals Agency (ECHA) requesting PFAS (per- and polyfluoroalkyl substances) be added to REACH. This proposal, if adopted, would be one of the most comprehensive changes to REACH since it was entered into force in June 2007. It would potentially ban all PFAS usage, which includes over 10,000 different substances.
The proposal comes after a sweeping three-year study by authorities from the five aforementioned countries, which found PFAS posed risks to humans and environments. The proposal states:
“PFASs are, or ultimately transform into, persistent substances, leading to irreversible environmental exposure and accumulation. Due to their water solubility and mobility, contamination of surface, ground- and drinking water and soil has occurred in the EU as well as globally and will continue. It has been proven very difficult and extremely costly to remove PFASs when released to the environment. In addition, some PFASs have been documented as toxic and/or bioaccumulative substances, both with respect to human health as well as the environment. Without taking action, their concentrations will continue to increase, and their toxic and polluting effects will be difficult to reverse.”
The dossier submitted consider two distinct restriction options:
The initial proposal was submitted to the ECHA on January 13, 2023. On March 22, the ECHA opened the proposal up to public commentary. Hundreds of comments have since been submitted by individuals and companies alike from around the world.
Some feature individuals who are happy to see proactive measures to safeguard human and environmental health and safety concerns. Many others request exemptions of certain substances, especially fluoropolymers, from additional regulation.
This window for public commentary on Annex XV will close on September 25, 2023, 23:59 Helsinki time, after which the ECHA committees will adopt their opinions and submit them to the European Commission.
Interested parties will need to submit comments using a form on the ECHA website. Comments can be submitted anonymously or with company and name information included. It is up to the individual to remove any identifying information from the comments.
The ECHA recommends submissions do the following:
More information on how to submit a comment can be found here: cad38c27-ede8-2268-00c6-939ea066743c (europa.eu)
Here are some of the comments already submitted by companies and individuals on the suggested restrictions:
“The European Chips Act wants to ensure that [Europe] is able to produce computer chips on a large enough scale to become [independent] from Asia. Production of computer chips requires ultra pure water and ultra pure chemicals. There is no way around using pipes, fittings, valves, and vessels made from PVDF, ECTFE, PFA, and PTFE in this industry.” - Individual, Austria
“We are also a manufacturer of shrink tubes and coating systems made of fluoroplastics for industrial applications, which are used in every conceivable industry. From the baker or butcher who provides his lighting with splinter protection to protect his products, to the sensor manufacturer who wants to significantly increase the life cycle of his electronic components, to the engineer who wants the ideal material for aerospace projects that can withstand all extreme requirements and at the same time has hardly any weight. Fluoroplastics such as PTFE, FEP, PFA and the 35 other materials in this group are unfortunately indispensable and irreplaceable due to their properties.- Dennis Olschowka, ESZ W. Becker GmbH, Germany
“Fluoropolymers should be exempted from all regulatory activities under the REACH restriction. Fluoropolymers can be classified as PFAS based on their molecular structure. However, their toxicological and ecotoxicological profile is essentially different from the majority of PFAS substances...The stability of fluoropolymers can be directly translated into unique and durable performance properties in many applications. For the new megatrends such as green hydrogen, 5G data transmission or e-mobility, fluoropolymers represent the suitable basis on which these innovations become possible in the first place.” - Individual, Austria
“PFAS are high technologie polymeres which are irreplaceable in our products, as there are no alternatives for these properties…PFAS is mandatory to fulfill the function of our pumps. PFAS are used as a coating in the pump and the mechanical and chemical function cannot be substituted by another product.” - Leistritz Pumpen GmbH, Germany
“Our objection is to exclude Fluoropolymers completely of this regulation, as they are polymers of low concern according to OECD scheme.” - Lenzing Plastics GmbH & Co KG
“Due to the outstanding performance of PTFE in terms of biocompatibility and long term stability with excellent long term data, PTFE is used in class 3 permanent implants (artificial heart valves) without any leachables or emissions in use phase.” - Lenzing Plastics GmbH & Co KG, Austria
“Our company Atolli Oy is providing low carbon footprint (LCA) pipelines, seals, valves, vessels for chemical and process industry. When building these pipelines, we are using semi finished products made out of PVDF, ECTFE, FEP, PFA and PTFE. These products have app. 5-10 times more lifetime and several times lower carbon footprint (LCA), than metal or any other alternative material in use. These pipelines are in use of chemical industry, battery industry, food and drug industry etc…Our target is to exclude fluoropolymers semi finished products from all regulatory activities under the REACH restrictions.” - Atolli OY, Finland
“In my view, this general ban does not sufficiently take into account the use of fluoropolymers, within the manufacturing processes of the (chemical) industry. To have highly stable and technically tight compounds is necessary to avoid diffuse emissions (of hazardous substances) to meet current emission restrictions for chemical plants. The fluorinated polymers are urgently needed here precisely because of their material properties (long-term stability, resistance to abrasive media, inert surfaces, ...) to achieve technically tight connections and as inliners for equipment (pipes, containers), a replacement is not available for every type of application.” - Individual, Germany
“An undifferentiated ban will inevitably have negative effects on existential future projects of mankind (energy transition, electrification in the automotive industry, chemical process industry, etc.).” - Individual, Germany
“In industrial inkjet printers, PTFE, ECTFE, PFA, ETFE, and FKM are used in wetted parts such as pipes, valves, and ink pumps through which printing ink passes. The reason is their chemical resistance to printing inks. Use of PTFE, ECTFE, PFA, ETFE, and FKM is essential and cannot be substituted.” - Company, AJapan
“In light of the fact that 90% of the materials we use are fluoropolymers or fluoroelastomers, many of which are qualified as compatible for food, pharmaceutical, and medical use, and there are currently no equally valid alternatives, we would like to understand if there is a possibility of excluding these substances (PTFE, FKM, FFKM, FEP) from the list of PFAS…Such restriction could lead to a total shutdown of our company.” - CAAST S.p.A, Japan
“...we haven't got an alternative product to replace our Fluoropolymer coatings…” -PPG, Turkey
“THE INCLUSION OF POLYMERS PTFE,FEP,FFKM,FKM,FEPM IN THE ABOVE MENTIONED LEGISLATION IS UNNECESSARY. THESE MATERIALS ARE USED IN SEALING PRODUCTS IN INDUSTRY WORLDWIDE WITH NO ALTERNATIVES.” - Company, United Kingdom
“Further a limitation of fluoropolymers will increase risk and negative impact on the EU society related to safety for humans and environment ( i.e. not achieving transportation CO2 emission legislations and CO2 targets in case of alternative materials (if possible) and designs over the lifetime of a product / application.” - Company, Norway
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