Document DN1XD1K7xwm7r65RnRzvN8rM

Specific Informa on Requests. 6: Missing Uses Annual tonnage (and emissions). The EFCTC estimates that the total European market for all fluoropolymers, including PTFE and PFA, was around 14,500 metric tons in 2020. Our estimated breakdown by industry sector of PTFE and PFA use in terms of PTFE / PFA fluoropolymer lined pipework and associated equipment is as follows; Semiconductor: 44% Pharmaceutical manufacture: 24% Fine chemicals manufacture: 22% Bulk chemicals manufacture: 6% Water treatment: 2% Oil and gas - downstream product manufacture: 2% Key func onali es provided by Fluoropolymers. The principal reason for using PTFE / PFA fluoropolymer lined pipework and associated equipment is the corrosion resistance of the fluoropolymer linings. This near universal corrosion resistance of the linings, allows customers to handle individual chemicals, mixtures of chemicals and different chemicals in series, without the need to change pipework when switching chemicals to be handled. This allows mul3-use manufacturing and processing plants to be built and avoids the necessity for duplicate produc3on lines to handle different chemistries which would be the case for all of the possible alterna3ve lining materials (i.e. glass lined steel, or exo3c metallic pipework such as 3tanium, Hastelloy, Incoloy, Inconel, and tantalum). PTFE / PFA fluoropolymer lined pipework and associated equipment is: Much more cost compe33ve than exo3c metallic alterna3ves which can be 5-10 3mes more expensive than PTFE / PFA fluoropolymer lined products. Exo3c metallic alterna3ves are also not as resistant to the variety of chemicals, temperatures and concentra3ons as fluoropolymers. PTFE / PFA fluoropolymer lined products are much easier to clean (very important for batch manufacturing plants) and so allow quick, efficient change-over of product processes. PTFE / PFA fluoropolymer lined products are mechanically more robust than glass lined pipework (very important if pipework has to be disassembled for cleaning). Number of companies in the sector es mated to be affected by the restric on. Within Europe, we have es3mated that over 3,000 companies use PTFE / PFA fluoropolymer lined products in various industries, including chemical processing, pharmaceu3cals, and food and beverage produc3on, among others. The availability, technical and economic feasibility, hazards and risks of alterna3ves for the relevant use, including informa3on on the extent (in terms of market shares) to which alterna3ve-based products are already offered on the EU market and whether any shortages in the supply of relevant alterna3ves are expected. 1 At present there are no alterna3ve materials that provide the crucial performance range achieved by exis3ng PTFE / PFA fluoropolymer lined pipework and associated equipment. Some of the non- fluoropolymer alterna3ves researched could be economically beneficial except that the opera3onal cost resul3ng from leakage, replacement and increased maintenance requirements from an inferior material would by far exceed any saving. Furthermore, alterna3ve materials are technically unsuitable in many required applica3ons. The alterna3ves listed below as replacement for PTFE / PFA fluoropolymer lined pipework and associated equipment do not possess the universal range of proper3es to be a suitable direct replacement, especially when their mechanical proper3es and their func3on differ depending upon their loca3on and purpose within the process in which they are being used. Increased Waste: The loss of fluoropolymers for manufacturing lining and sealing materials would require a significant increase in the number of pipes, valves, seals and gaskets manufactured for maintenance replacement parts due to the fact that the listed alterna3ve materials do not achieve the same range of substance compa3bility and durable life expectancy. This would inherently raise the risk of leakages caused by inadvertently fi?ng incompa3ble products to different processes as well as significantly increase the waste streams produced by frequent repurposing of the produc3on plant. Fundamentally, many industries would not be able to cope with this drama3c change. It might cause a reduc3on in produc3on capacity and an increase in costs and the reloca3on of manufacturing and processing business to outside of the impacted countries (the EU). PTFE, ETFE, PVDF, PFA, FEP, FKM, FFKM Although there are alterna3ve non-PFAS materials each with capabili3es of temperature and chemical compa3bility, none has the unique combina3on of temperature range and chemical compa3bility of PTFE and similar fluoropolymer materials. To restrict the en3re range of fluoropolymer materials irrespec3ve of its solid form and use, would severely disrupt the pharmaceu3cal, chemical, food and water industries and in some instances would curtail some opera3ons. The altera3ve materials are incompa3ble with some applica3ons such as the transport of cryogenic liquified gases, chlorine, anhydrous hydrogen fluoride, hydrofluoric acid solu3ons, hydrochloric acid and sulfuric acid, to name a few. At a prac3cal level, lined pipework and associated products tend to look very similar in appearance. The tradi3onal `milky white' colouring associated with PTFE and PFA lined equipment is the almost iden3cal to that of the less resilient lined products which could lead to confusion and errors in installa3on/replacement leading to product contamina3on, system failure and leakage of chemicals due to incorrect usage. Ultra-High-Molecular-Weight Polyethylene "UHMWPE" Ultra-High-Molecular-Weight Polyethylene "UHMWPE" has been researched as a possible alterna3ve to a PTFE / PFA fluoropolymer lined pipework and associated equipment. However, it is only able to reduce corrosion resistance at lower temperatures. The temperature, chemical resistance range and rigidity UHMWPE (par3cularly at elevated temperature) is insufficient as direct replacement PTFE / PFA fluoropolymer lined pipework. 2 `Exo c metal' lining materials: An alterna3ve to products being lined with PTFE / PFA fluoropolymers is the use of so called `exo3c metal' linings. However, there are both prac3cal and economic issues associated with this `alterna3ve'. Cost: 5 - 10 3me more expensive - which can make some industries not cost compe33ve. Longevity: For a single use/individual chemical exo3c metals can be used, but if handling combina3ons of product at varying temperatures they may not be suitable. This means that there is always a possibility that the wrong chemical can be transported in a par3cular pipe which may give rise to contamina3on of product, the environment and poten3al risk to health and life. Availability: Many exo3c metallics are in short supply and oFen mined in inhospitable and/or poli3cally unstable countries with liGle or no Health and safety legisla3on. Environmental damage: Exo3c metals must be mined, transported, refined and, processed which can have a significant environmental impact. This is par3cularly true when the raw materials are mined in less developed na3ons where environmental protec3on legisla3on is less well developed than in the EU. Persistence: For these materials to handle the opera3ng condi3ons, they are inherently persistent in the environment. Risks: In most cases, exo3c metallic op3ons do not provide the almost universal chemical resistance provided by fluoropolymer lined products. This can lead to: o shorter lifespans of products (increased replacement costs) o increased maintenance costs (addi3onal monitoring of products to ensure that they are s3ll fit for purpose), o an increased risk of catastrophic failure, par3cularly if an unsuitable chemical is put through the pipework, (poten3ally leading to release of hazardous chemicals into the environment, damage to surrounding process plant, injury to plant personnel, and possibly the wider public, depending upon the nature of the failure). In addi3on to technical risks, there are market risks. At present many of the exo3c metallic alloys considered are difficult to purchase (lack of availability, fluctua3ng prices, long lead 3mes), making the construc3on of a process plant using them problema3c as well as cost uncompe33ve. Glass lined steel piping: Glass lined piping is also considered as an alterna3ve to the use of PTFE / PFA fluoropolymers. However, again there are similar prac3cal and economic issues associated with this `alterna3ve'. o Longevity: For a single use/individual glass lined pipework can be used, but if handling combina3ons of product at varying temperatures they may not be suitable. This means that there is always a possibility that the wrong chemical can be transported in a par3cular pipe which may give rise to contamina3on of product, the environment and poten3al risk to health and life. o Persistence: For these materials to handle the opera3ng condi3ons, they are inherently persistent in the environment. o Risks: In most cases, glass lined piping op3ons do not provide the almost universal chemical resistance provided by fluoropolymer lined products. This can lead to: shorter lifespans of products (increased replacement costs) increased maintenance costs (addi3onal monitoring of products to ensure that they are s3ll fit for purpose), an increased risk of catastrophic failure, 3 par3cularly if an unsuitable chemical is put through the pipework, (poten3ally leading to release of hazardous chemicals into the environment, damage to surrounding process plant, injury to plant personnel, and possibly the wider public, depending upon the nature of the failure). Robustness: Glass lined pipework is less mechanically robust than PTFE / PFA fluoropolymer lined pipework, making damage during ini3al installa3on or disassembly and reassembly for cleaning more likely Polypropylene, Silicone, PVC (tank lining suggested alterna ves) PVC-U has a temperature range of 0C to +60C which is too low for most process industries. PVC-U is also not resistant to many chemicals including aroma3c and chlorinated hydrocarbons or chlorine. Addi3onally, PVC-U may not be suitable due to the poten3al to emit corrosive/poisonous chlorine gas which can cause chloride stress corrosion cracking in austeni3c stainless steels, which is the material used for many pipes and valves. PVC also contains SVHC which is likely to be restricted by other environmental regula3ons. Polypropylene Polypropylene has a slightly wider temperature range of -10C to +80C but s3ll not sufficient to sa3sfy most of the associated industry applica3ons. Polypropylene has a wide chemical resistance at ambient temperature, but its chemical resistance significantly reduces with increased temperature par3cularly with strong inorganic acids. Elastomeric compounds Some Silicone grades have a temperature range of -55C to +300C and can be used within sealing elements in certain applica3ons but are not resistant to many of the chemicals used in produc3on including most solvents and hydrochloric or hydrofluoric acids. The lack of hardness also restricts the use of these material for some sealing elements. Elastomeric compounds such as silicone, nitrile, and neoprene, can also be regarded as bio- accumula3ve and toxic to the environment. For cases in which alterna3ves are not yet available, informa3on on the status of R&D processes for finding suitable alterna3ves, including the extent of R&D ini3a3ves in terms of 3me and/or financial investments, the likelihood of successful comple3on, the 3me expected to be required for subs3tu3on (including any relevant cer3fica3on or regulatory approvals) and the major challenges encountered with alterna3ves which were considered but subsequently disregarded. At present we are unaware of any poten3al alterna3ves currently under development, but not yet available. For cases in which subs3tu3on is technically and economically feasible but more 3me is required to subs3tute: At present we are unaware of any poten3al alterna3ves currently under development, but not yet available. For cases in which subs3tu3on is not technically or economically feasible, informa3on on what the socio-economic impacts would be for companies, consumers, and other affected actors. If available, please provide the annual value of EU sales and profits of the relevant sector, and employment numbers for the sector. 4 Pharmaceu cal manufacture: Whilst pharmaceu3cals as a product do not contain PTFE / PFA fluoropolymers as discussed in this response, PTFE / PFA fluoropolymer lined products are necessary for their produc3on. Pharmaceu3cal companies tend to be large mul3na3onal organisa3ons, producing high value products in facili3es that are expensive to build and maintain. A ban on the use of PTFE / PFA fluoropolymers in such plants will make their opera3on significantly more costly. Consequen3ally, if fluoropolymers are banned in the EU, it is likely that these companies will simply move their produc3on to alterna3ve geographical loca3ons, leading to a significant loss of manufacturing capacity, skilled employment, and intellectual property from the EU, also significantly damaging the EU's preparedness for future pandemics. Non-European pharmaceu3cal companies are already well established but will be even more dominant if PTFE & PFA are banned. It is eminently possible that due to the likely transi3on of manufacturing from the EU, exis3ng shortages on medicine across Europe will get even worse. 5