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FPP4EU and PFAS REACH restriction

  1. FPP4EU and PFAS REACH restriction Patricia Muñoz FPP4EU Sector Group Manager The European Chemical Industry Council, AISBL – Rue Belliard, 40 - 1040 Brussels – Belgium Transparency Register n°64879142323-90 8 March 2023
  2. Who are we Universal PFAS restriction PFAS and PFAS applications Call for action The Collaboration Platform
  3. Who are we Universal PFAS restriction PFAS and PFAS applications Call for action The Collaboration Platform
  4. 4 There are theoretically hundreds or even millions of PFAS molecules Substances that contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I atom attached to it). Note: This includes among others short and long chain PFAS, fluoropolymers and F-Gases. PFAS definition
  10. HEALTH
  11. HEALTH
  22. Industrial settings
  23. Industrial settings
  24. PFAS materials used in factories 24
  25. Who are we Universal PFAS restriction PFAS and PFAS applications Call for action The Collaboration Platform
  26. Vision – in a nutshell We understand and support the need for balanced regulatory action on PFAS. We seek to aid EU policymakers in achieving the ambitions set out in the EU Green Deal. Aim is to come jointly to a final regulatory measure which: • is science-informed, implementable, and enforceable; • enables the EU to meet its Green Deal, economic and other policy objectives. Our plans: • obtain common understanding of what a PFAS restriction under REACH may look like, • collaborate and engage in constructive dialogues with all EU stakeholders, • support further research and data generation to fill potential data gaps. Introducing FluoroProducts and PFAS for Europe 26
  27. Who are we? Membership Represents producers, importers and users of the many potential substances that fall within the broad definition of PFAS. 27
  28. How are we organized? Grouping Sub team Advocacy/Comms Working Group (Eco)Toxicology Working Group Technical Working Group Management Committee Collaboration Platform 28
  29. Who are we Universal PFAS restriction PFAS and PFAS applications Call for action The Collaboration Platform
  30. • Objective of the Universal PFAS (U-PFAS) restriction Starting point​ is a BAN on PFAS: Regularity option 1: no derogations and​ a transition period of​ 18 months Regulatory option 2: some use-specific derogations • Justification by the 5 Competent Authorities:  Persistence is key for justifying the restriction in terms of risk, all PFAS are persistent by themselves or degrade to other persistent PFAS  There are other concerns (mobility, toxicity, ….) that vary among PFASs  Emissions need to be addressed: estimated emissions of about 4.4 million tones over 30 years if no action taken • Scope Very broad, includes fluoropolymers, perfluoropolyethers, F-gases and side-chain fluorinated polymers. Some PFAS deemed non persistent are excluded The U-PFAS restriction proposal 30
  31. • An unprecedent restriction that imposes a ban on the manufacturing, placing on the market and use of PFAS, together with a ban on placing on the market of mixtures or articles containing PFAS above a specific concentration level, and includes use specific derogations.​ • PFAS used in industry settings are included in the scope. 31 The U-PFAS restriction proposal If a use is not derogated = banned 18m after Entry into Force (EiF)
  32. Three main types of derogations: • Exclusion (time-unlimited derogation) for active substances in biocidal, plant protection and human & veterinary medicinal products (with a reporting obligation). • Evidence-based time-limited derogations (6.5 or 13.5 years after EiF): cover specific uses in food contact materials, medical devices, membranes in fuel cells, refrigerants, insulating materials, textiles, etc. • Time-limited derogations (6.5 or 13.5 years after EiF) with a weak base evidence: cover inter alia certain uses of PFAS in textiles (incl. PPE), very specific industrial uses, engineered fluids for medical devices, transport applications, etc. The U-PFAS restriction proposal 32
  33. • Plant production​ products, biocides ​and human & veterinary medicines active substances derogated, but ​no derogation for ​intermediates, ​processing aids. • 46 time-limited derogations on very specific uses. Most of them covering industrial and professional uses, medical devices, textiles (PPE) and refrigerants. • Consumer uses e.g. cosmetics, home and electronic appliances, textiles ( besides PPE) etc. are banned with few exceptions. • The objective of the proposal submitted by the competent authorities is to ban the manufacture, production, use and import of PFAS in EU. Conclusions and impact 33
  34.  The U-PFAS restriction The proposal of the dossier submitters will ban an unprecedent number of PFAS uses We have compared the proposal with a study done on the uses of PFAS and only 3% of those uses will be covered by the derogations Impact: Glüge report and the derogations proposed in the U-PFAS Restriction proposal 279 48 11 11 349 NON-EXHAUSTIVE USES IDENTIFIED IN GLÜGE NOT EXPLICITLY COVERED POTENTIALLY PARTIALLY COVERED POTENTIALLY COVERED UNKNOWN 34
  35. Page 35 * Assuming the earliest possible timeline. The restriction proposal – indicative timeline Dossier Preparation WE ARE HERE Political process 5 CA submits dossier 13 January 6-month public consultation 22 March ‘23 – 22 Sep ’23 ECHA sends compiled opinions to COM ~ Q2 ‘24 60-day public consultation on SEAC DO Dec ’23- Feb ’24? RAC & SEAC Plenary RAC-64: 15 March SEAC-58: 10 March RAC & SEAC Plenary (RAC opinion and SEAC draft opinion*) RAC-67: Late Nov SEAC-61: Late Nov – Early Dec ECHA publishes dossier 7 February RAC & SEAC Plenary RAC-65: Early Jun SEAC-59: Early – Mid Jun RAC & SEAC Plenary RAC-66: Mid Sep SEAC-60: Early – Mid Sep SEAC adopts final opinion* SEAC-62: Early – Mid March RAC opinion development SEAC opinion development Publication in OJ ~ Q4 ’25 or Q1 ‘26 EiF Following EU Commission proposal, scrutiny by EP & Council ECHA & COM process (18-24 months) 5 CA RoI Jul ‘21 Last updated: Feb 2023 COM adoption ~ Q4 ’24 or Q1 ‘25 5 CA extension of submission date Feb ‘22 Public Consultation Period REACH Committee ECHA process RAC-65 REST WG Mid May RAC-66 REST WG Late Aug RAC-67 REST WG Early Nov 2023 2024 22 May Intermediate deadlines for specific points 22 July • RAC plenary is typically held for one week, and SEAC is for two weeks. • RAC working groups are organised to clarify some topics and used to sort out issues. Main discussions are more and more taking place in the working groups and less in plenary - presence of experts is recommended. 22 September
  36. Who are we PFAS REACH restriction PFAS and PFAS applications Call for action The Collaboration Platform
  37. FPP4EU covers a complex sector We are dealing with hundreds of substances with diverging properties, used in many applications across an extended value chain. 37
  38. Collaboration Platform 101 Members including AFEMs 10 countries Biggest representation in BE, DE, FR OUR DOWNSTREAM USERS COVER THE MAJORITY OF INDUSTRIAL ECOSYSTEMS Collaboration Platform: membership (members and observers) 38
  39. We organise meetings to discuss the potential impact of the restriction on different sectors, in compliance with competition law; We organise workshops where regulators are invited to explain the proposal and its potential consequences for the industry; We exchange relevant information focused on the U-PFAS restriction including the understanding the restriction process and the parties' proposals; 39 Collaboration Platform
  40.  We collect examples of PFAS used throughout different value chains in the EU – Case studies.  We only work in non-exhaustive specific example lists’ form; never claiming that no alternative exists and never favouring one substance over another!  We aim to open the doors for individual sectors to defend their own cases. Collaboration Platform 40
  41. 41
  42. Who are we Universal PFAS restriction PFAS and PFAS applications Call for action The Collaboration Platform
  43. Call for action: we invite you to… 43 Participation is free of charge! Join our Collaboration Platform!
  44. Page 44 Call for action: we invite you to… Collect data on • (non-)availability of alternatives to PFAS • realistic emission control measures Analyse • where the restriction may have an impact (incl. equipment used onsite) • current emission control measures Feed data into public consultations on • (non-)availability of alternatives • cost impact* • initiatives to reduce emissions Contact us • on the lengthy and complex process • on the complex PFAS file * Cost impact typically includes • producer surplus losses • employment losses • consumer surplus losses • welfare losses
  45. Selected case studies of PFAS applications Stefanos Geros EU Policy & Advocacy Advisor The European Chemical Industry Council, AISBL – Rue Belliard, 40 - 1040 Brussels – Belgium Transparency Register n°64879142323-90 8 March 2023
  46. • Heat Pumps: A future-proof solution for sustainable heating and cooling; • The EU has committed to reach climate neutrality by 2050; • Decarbonisation of the heating and cooling sector a key element of Europe’s climate strategy; • Could help avoid up to 570 million tons of CO2 emissions from fossil fuels until 2050; • F-Gases are used in the refrigeration cycle. Renewable energy 46
  47. • PFAS in pharmaceutical drugs to battle cancer; • The API Sorafenib has been proven to be effective against kidney, renal, pelvic, thyroid, hepatocellular (HCC) and liver cancer; • It slows down cancer cell growth and prevents blood supply to cancer tissue; • Approximately 2.5 to 5 million doses of Sorafenib are applied per year in Europe; • PFAS also used in the production process of medication and vaccines. Medical sector 47
  48. • PFAS are used throughout the food sector; • Proper lubrication of ovens reduces wear of the equipment; • High temperature stability and lubricity; • Help companies prolong the lifetime of their production equipment; • Food gases are used to naturally preserve food products and prolong expiration dates; • F-Gases used in industrial refrigerators. Food sector 48
  49. • PFAS used in different car parts; • Lithium-ion traction batteries and fuel cells rely significantly on fluoropolymers; • Fluorinated gases (F-gases) are used for cooling and heating the cabin; • Fluoropolymers and fluorotelomers are crucial for vehicles’ safety, power electronics and infotainment systems; • Lubrication of numerous components within a vehicle. Automotive 49
  50. More case studies on 50
  51. For any questions please contact: Patricia Muñoz FPP4EU Sector Group Manager THANK YOU ! The European Chemical Industry Council, AISBL – Rue Belliard, 40 - 1040 Brussels – Belgium Transparency Register n°64879142323-90 8 March 2023

Notes de l'éditeur

  1. The current leading technology in electric vehicles are lithium-ion traction batteries and fuel cells, which rely significantly on fluoropolymers. They provide important performance and safety attributes that guarantee lithium-ion batteries ‘safety, high energy density, power delivery and longer lifespan.  F-gases with very low Global Warming Potential are used for cooling and heating in the cabin as well as for cooling the battery.  Fluoropolymers and fluorotelomers are crucial for vehicles’ safety, power electronics and infotainment systems, among others, they are used in semiconductors, membranes and technical textiles.
  2. Data centres used for storage or data processing rely heavily on PFAS. By immersing IT hardware in data centres in a non-conductive fluorochemical liquid, the need for chiller-based air cooling is eliminated. Fluoropolymers and fluorotelomers are key in semiconductor manufacturing, protecting the wafer from getting burned during the etching process. Expanded polytetrafluoroethylene (ePTFE) membranes safeguard built-in speakers and microphones.
  3. Active pharmaceutical ingredients (API) in medicinal products containing fluorine play a key role in modern day cancer therapy. PFAS in the form of fluoropolymers and fluororubbers are used in laboratory equipment as these materials are characterised by high resistance levels against chemicals and extreme purity. PFAS are also used in vacuum technology, a method required in all areas of science and technology, in many production processes and research.
  4. F-Gases possess unique characteristics that enable heat pumps to operate despite the complexity of the parameters that need to be taken into account.  Lithium-ion batteries rely heavily on PFAS.  Fluorochemicals are present in the electrolyte to function as a conductive salt and as performance enhancing additives. The oxidation stability of fluorinated polymers enables their use in cathode materials, and are also fit for purpose for future materials which are more sustainable, less expensive, and less dependent on critical raw materials such as cobalt.  Polytetrafluoroethylene (PTFE) and Fluorinated ethylene propylene (FEP) are materials of choice for sealing components used in the production, transport and storage of green hydrogen.
  5. Plane engines can heat up to such levels that sealants are exposed to temperatures of over 200°C. (Per-)Fluoroelastomers are currently the only elastomeric compounds resilient enough to withstand the extreme thermal, mechanical and media exposure. Electrical cables need to be flexible and resistant to high as well as low temperatures in planes, which can go as low as -70°C. PFAS are used in this application due to their exceptional electrical and resistance properties, fire and flame retardancy, retention under a wide range of temperatures, and exposure to specialty fuels that may be chemically aggressive.
  6.  It is important that the lubricants used in baking ovens have high temperature stability and lubricity. Lubricants based on PFAS are designed for extended life-time or even for-life lubrication. They help companies prolong the lifetime of their own technical products as well as their production equipment. Hydrofluorocarbons (HFCs) and Hydrofluoroolefins (HFOs) are widely used F-Gases in commercial refrigeration, since they are highly energy efficient, and are characterised by low levels of toxicity and flammability. These F-Gases allow the refrigeration cycle, meaning the transfer of heat from one place to another, to work in a safe and energy efficient manner. System performance and energy efficiency can potentially have a far greater effect than the Global Warming Potential of the refrigerant itself.
  7. When constructed with other components, such as textiles and flame-resistant technologies, the resulting ePTFE-based fabrics provide advanced thermal and mechanical properties needed to protect against the hazards for the electric arc flashes. The benefits of arc-rated protective ePTFE-based fabrics made using fluoropolymers and other fluoromaterials are multiple. They safeguard the health and wellbeing of the wearer by providing waterproof, windproof, and breathable benefits and in addition highly functioning, protective characteristics. Note: This case study is also featured at the end of the presentation so maybe skip this part and present it later.
  8. Spray polyurethane foam (SPF) is a foam insulation with blowing agents that enable the foam to expand and harden during application, effectively sealing any cracks, joints, or seams. HFOs (Hydrofluoroolefins) act as blowing agents in the production of insulation foams. HFOs have unique physical properties enabling energy efficiency innovations for a range of different applications and can play an integral part in achieving the goals of the European Green Deal.
  9. PFAS are used in a wide range of applications within industrial settings. From filtration and separation media used in high performance air and liquid applications, to coatings used in pipes and expansion joints. PFAS are used in pipes, expansion joints, vessels, and fittings extensively in the chemical processing industry, with the objective to protect equipment from direct contact at high temperatures (up to 230°C) and very aggressive media. Polytetrafluoroethylene (PTFE) based materials are essential components of highly reliable sealing mechanisms such as gaskets, which fill the space between interconnected machines or storage containers, allowing the use and transportation of hazardous chemicals.