EU Regulations on PFAS: Implications for PTFE on Seal Manufacturers
1. Introduction:
1.1 The Growing Concern Over PFAS and EU Regulatory Response
Per- and Polyfluoroalkyl Substances (PFAS) represent a vast and diverse group of synthetic chemicals, that have been widely utilized across numerous industries and consumer products due to their unique properties.1 These properties, including exceptional resistance to water, grease, and stains, have made them invaluable in applications ranging from non-stick cookware and food packaging to water-repellent textiles and firefighting foams. However, the remarkable stability of PFAS, which contributes to their desirable properties, has also led to increasing global concern.2 These substances are often referred to as “forever chemicals” because they persist in the environment for exceptionally long periods and have the potential to accumulate in living organisms, raising significant concerns about their long-term environmental and health impacts.2
In response to these growing concerns, the European Union (EU) has taken a proactive stance in addressing the risks associated with PFAS through its comprehensive chemicals legislation.5 The European Commission has explicitly committed to taking action on PFAS through these legislative tools and other measures, with a stated aim of phasing out their use within the EU unless their use is deemed essential.10
This indicates that industries that rely on PFAS, such as companies which manufacture seals using PTFE (a type of PFAS), will likely face increasing pressure to adapt their practices and transition towards safer and more sustainable alternatives.
1.2 Understanding Fluorosurfactants
Fluorosurfactants constitute a distinct and important subgroup within the larger family of PFAS.2 Common examples of fluorosurfactants include perfluorosulfonic acids (PFSAs), such as the well-known perfluorooctanesulfonic acid (PFOS), and perfluorocarboxylic acids (PFCAs), like perfluorooctanoic acid (PFOA) and perfluorononanoic acid (PFNA).2 The unique combination of exceptional chemical stability and potent surface activity has rendered fluorosurfactants indispensable in a wide array of industrial applications.44
2. The Genesis of the PFAS Regulations
2.1 Key Regulatory Bodies
The European Commission has explicitly stated its dedication to phasing out PFAS within the EU, allowing for exceptions only where their use is considered indispensable.10 The European Chemicals Agency (ECHA) is tasked with evaluating proposals for restricting substances like PFAS and providing scientific and technical opinions to the Commission, which then informs policy decisions.10
2.2 Scientific Evidence and Key Findings
The regulatory drive behind the EU’s PFAS regulations is firmly grounded in a substantial body of scientific evidence that has highlighted the adverse health effects associated with exposure to various PFAS.2 Studies have linked PFAS exposure to a range of health issues, including decreased fertility, developmental delays in children, an increased risk of certain cancers (such as kidney, testicular, liver, and pancreatic cancers), thyroid disease, ulcerative colitis, and negative impacts on the immune and hormone systems.2 Furthermore, there is overwhelming evidence of widespread environmental contamination of drinking water sources, surface waters, groundwater, soil, and air due to the remarkable persistence and mobility of many PFAS.2 These chemicals have been detected even in remote and seemingly pristine environments like Antarctica, highlighting their capacity for long-range transport and global distribution.2
3. Current Status of the PFAS Regulations (April 2025)
3.1 Proposed Universal Restriction
A significant development in the EU’s approach to PFAS regulation is the ambitious proposal submitted in February 2023 by five EU Member States – Denmark, Germany, the Netherlands, Norway, and Sweden – to the European Chemicals Agency (ECHA).3 This proposal calls for a comprehensive restriction on the manufacture, use, and placing on the market of all PFAS under the REACH Regulation, aiming to cover an estimated 10,000 of these chemicals.13 The proposal is currently undergoing a rigorous, multi-year evaluation by ECHA’s Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC), which are meticulously assessing the potential impacts of the proposed restrictions across a wide range of industries.13 Provisional conclusions have been reached for several key sectors, including fluorinated gases, transport, and energy.26 The anticipated timelines for this evaluation involve RAC and SEAC concluding their assessment of the restrictions by industry in
2026, followed by a final decision from the European Commission and EU member countries in 2027, with a potential entry into force of the restriction in 2028 or 2029.13 However, it is important to note that some sources suggest the final decision might face delays beyond 2025 due to the complexity of the analysis and ongoing discussions.30 The restriction proposal outlines different options for implementation, including a full ban with an 18-month transition period without any derogations, as well as a ban with potential derogation periods of 5 or 12 years for specific uses where viable alternatives are not yet available.13 Furthermore, alternative options are being considered, such as conditional authorisations for the continued use of PFAS in sectors deemed critical, such as batteries, fuel cells, medical devices, and semiconductors.16
3.2 Existing Bans and Restrictions
While the universal restriction proposal is under evaluation, the EU has already implemented a significant number of regulations targeting specific PFAS. Under the POPs Regulation, several well-known fluorosurfactants are subject to bans and strict limits. Perfluorooctane sulfonic acid (PFOS) and its derivatives have been banned with a maximum limit of 10 parts per million (ppm).5 Perfluorooctanoic acid (PFOA), its salts, and related compounds have been banned since July 2020.5 More recently, Perfluorohexane sulfonic acid (PFHxS), its salts, and related compounds were added to the POPs Regulation in August 2023, with a stringent limit of 25 parts per billion (ppb).5 The REACH Regulation also imposes restrictions on various PFAS. Perfluorinated carboxylic acids (C9-C14 PFCAs), their salts, and related substances have been restricted since February 2023, with maximum limits of 25 ppb for the sum of C9-C14 PFCAs and their salts, and 260 ppb for the sum of C9-C14 PFCA-related substances.5 Additionally, Undecafluorohexanoic acid (PFHxA), its salts, and related substances are slated for restriction in April and October 2026, with limits set at 25 ppb for the sum of PFHxA and its salts, and 1000 ppb for the sum of PFHxA related substances.5 Furthermore, certain PFAS, including Perfluoroheptanoic acid (PFHpA), PFHxS, Perfluorobutane sulfonic acid (PFBS), and GenX, have been identified as “Substances of Very High Concern” (SVHC) and added to the candidate list under REACH, signaling a high level of concern and the potential for future restrictions.3 Beyond specific substance restrictions, the Drinking Water Directive sets EU-wide limit values for PFAS in drinking water at 0.1 micrograms per liter (μg/L) for the sum of 20 individual PFAS and 0.5 μg/L for the total concentration of PFAS, with Member States required to ensure compliance by January 2026.4 The EU Regulation 2022/2388 establishes maximum levels for specific PFAS, including PFOS and PFOA, in various food products such as eggs, fish, meat, and seafood, and has been in effect
since January 2023.1 In addition to these EU-wide measures, some Member States have taken their own regulatory actions. For example, France has implemented a national ban on the manufacture, import, export, and marketing of products containing PFAS in items like clothing, footwear, cosmetics, and ski wax, effective from January 1, 2026, with a broader restriction planned for all textile products by 2030 unless deemed necessary for essential uses.25 This existing framework of bans and restrictions demonstrates a phased approach by the EU to address the risks posed by PFAS, with the ongoing evaluation of the universal restriction indicating a potential move towards even more comprehensive measures in the future. The varying levels of regulation at both the EU and national levels highlight the complexity of the current landscape for industries utilizing these chemicals.
3.3 Table of Currently Restricted PFAS
4. PTFE: A Carrier of PFAS
While PTFE in its final, high-molecular-weight form is generally considered non-toxic and safe for its intended uses due to its inherent inertness and stability 58, environmental concerns do exist regarding the potential for the release of PFAS during its production, processing, and disposal.58 The use of fluorosurfactants (such as PFOAs) during PTFE manufacturing can lead to the release of these persistent chemicals into the environment.59 Additionally, the processing of PTFE at high temperatures, such as during sintering, can potentially release fluorinated compounds.58 Furthermore, the disposal of PTFE-containing products, particularly through incineration, has been shown to generate other PFAS, contributing to the overall environmental burden.58 Therefore, a comprehensive assessment of the environmental implications of PTFE must consider all stages of its lifecycle, from the raw materials and processing aids used in its production to its eventual disposal.
5. Exploring Alternatives to PFAS in Seal Manufacturing
5.1 Potential Alternative Materials
The increasing regulatory scrutiny on PFAS is prompting industries to actively explore and identify potential alternative materials for various applications, including the manufacturing of seals for valves, pumps, and even demanding applications like earth-moving trucks.83 When considering alternatives, it is crucial to evaluate their ability to meet the critical performance requirements of seals, such as chemical resistance to a wide range of fluids, the ability to withstand specific temperature ranges and pressures, a suitable coefficient of friction for proper sealing function, and long-term durability, including resistance to wear and a sufficient lifespan.83 Cost-effectiveness is also a significant factor in material selection. Some potential alternative materials being explored include: High-Performance Polymers such as Polyaryletherketones (PAEKs) like PEEK, PEK, and PEKK, which are known for their exceptional resistance to high temperatures and various chemicals 90; Polyimides (PI) like Meldin HT, which offer excellent thermal stability and mechanical properties, making them suitable for demanding environments 85; and Polyphenylene Sulfide (PPS), which provides good chemical resistance and high-temperature performance.90 Ultra-High Molecular Weight Polyethylene (UHMW PE), such as materials marketed under the name ESKABASE, offers good wear resistance and chemical inertness, although its suitability may be limited to applications with temperatures below 100°C.90 The industry is also witnessing the development of Next-Generation Elastomers, including advanced formulations of EPDM, HNBR, and VMQ (silicone rubber), which are being engineered as PFAS-free alternatives for specific sealing applications.91 High-Performance Polyurethane, such as Freudenberg’s “98 AU 30500,” is another alternative that offers excellent wear and media resistance, particularly for hydraulic sealing systems.92 Metal Seals, constructed from various metals like stainless steel, Inconel, and other nickel alloys, provide exceptional performance in extremely high-temperature and high-pressure environments and exhibit compatibility with a broad range of aggressive chemicals.85 Lastly, Graphite-Filled PTFE, while still containing PTFE, is sometimes used in specific sealing applications where the addition of graphite can modify its properties to enhance performance.71 The availability of this diverse range of non-fluorinated materials suggests that viable alternatives to PFAS exist for many seal manufacturing applications. However, the selection of the most appropriate material will depend on a thorough evaluation of the specific performance requirements and operating conditions of the intended application.
5.2 PFAS Surfactant-Free Grades as Alternatives
It is important to confirm that “PFAS surfactant-free grades” of PTFE and potentially other fluoropolymers are indeed being actively developed and marketed as alternatives to traditional PFAS-containing materials.44 These grades are significant because they aim to retain the highly desirable performance attributes of fluoropolymers, such as their exceptional chemical resistance and low coefficient of friction.44 At the same time, they address the growing environmental and regulatory concerns that are associated with the use of fluorosurfactants in the production of traditional fluoropolymers.44 By eliminating or significantly reducing the use of these problematic processing aids, surfactant-free grades offer a direct alternative within the fluoropolymer family. This allows companies to potentially maintain their existing material specifications and manufacturing processes with minimal disruption, while still taking a crucial step towards reducing their reliance on fluorosurfactants, which are under increasing scrutiny.44 However, it is essential to reiterate that the base polymer in these “surfactant-free” grades is still a PFAS, and therefore, their long-term regulatory status might still be subject to future developments and broader regulations targeting the entire class of these chemicals.
6. Challenges with Alternatives
While alternatives like PFAS surfactant-free grades and materials from other chemical families exist, they don’t always offer a direct, one-to-one replacement for the unique properties of materials like PTFE, FKM, and FFKM.
Here are some of the challenges involved if comprehensive PFAS regulations come into action:
- Performance Limitations of Alternatives: Non-PFAS alternatives, such as next-generation EPDM, HNBR, VMQ compounds, or even high-performance polymers like PEEK and polyimides, might not match the combined high temperature resistance, chemical inertness, and low friction coefficient that fluorinated materials offer. This means that for certain demanding applications, especially in industries like aerospace, chemical processing, and some areas of automotive, current alternatives might not provide the same level of reliability and durability.
- Need for Multiple Variants: The versatility of fluorinated polymers has made them a universal material for a wide range of applications. Without them, industries might need to select several different material variants depending on the specific product and operating conditions, increasing complexity and potentially costs.
- Cost Considerations: In some cases, like non-fluorinated firefighting foams, larger volumes of the alternative might be needed to achieve similar performance to PFAS-based products, potentially increasing costs. Similarly, some high-performance non-fluorinated polymers can be more expensive than traditional fluoropolymers.
- Limited Direct Substitutes: For certain critical applications, particularly those requiring a unique combination of extreme properties, technically and economically feasible alternatives might not yet exist. The sealing industry itself estimates that only about 20% of current PFAS-containing products have the potential to be substituted with non-PFAS alternatives.
- Validation and Testing: Any transition to new materials requires extensive testing and validation to ensure they meet the stringent performance and safety standards of the applications they are intended for. This process can be time-consuming and resource-intensive.
- Impact on Existing Equipment and Processes: Industries that have relied on PFAS for a long time might face challenges in adapting their existing equipment and manufacturing processes to accommodate new materials.
Considering these challenges, many in the industry believe that a complete ban on all PFAS without carefully considered derogations for essential uses could lead to significant losses in material properties, performance, and product longevity in critical sectors. While the development of alternatives, including surfactant-free grades, is a positive step, it seems that we may not yet be fully ready for a complete ban on all PFAS across all applications, especially where high-performance sealing solutions are required. A more nuanced regulatory approach that considers essential uses and allows for a transition period for innovation and adoption of alternatives might be necessary.
7. Conclusion: Navigating the Future of PFAS Regulations and Industrial Adaptation
In conclusion, the regulatory landscape for PFAS within the European Union is dynamic and becoming increasingly stringent. Industries that utilize these chemicals must navigate this evolving environment proactively. One must adopt a forward-thinking approach to understanding and preparing for the future of PFAS regulations, emphasizing the importance of both diligent compliance and proactive innovation in the pursuit of safer and more environmentally responsible industrial practices.
