Document 91V088D4BpvEz0dyVekL3LDdD

NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) September 18, 2023 The general comment to the Restriction report on Per- and polyfluoroalkyl substances (PFAS) We, NIPPON ELECTRIC CONTROL EQUIPMENT INDUSTRIES ASSOCIATION ( NECA ) , would like to express the gratitude of having the opportunity of stating our opinion to the general comment to the Restriction report on Per- and polyfluoroalkyl substances (PFAS). https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/72301/term EU Commissions, ECHA and the industries not only in the EU but also outside the EU have made a great effort to reduce the hazardous substances over 15 years. We also would like to express deep respect to the efforts. The contact person of this comment: Name: Masatoshi Tsuruoka Organisation: NIPPON ELECTRIC CONTROL EQUIPMENT INDUSTRIES ASSOCIATION ( NECA) Email: @neca.jp 0 Introduction 0.1 On board with the purpose of EU REACH Regulation The REACH Regulation has been carrying out the great role of contributing to human health by reducing the exposure risk to hazardous substances. This Regulation with foresight has been expanding globally due to the advantages and benefits to the Society. We fully understand the importance of the REACH Regulation which shall be respected and has been contributed to the REACH through our technologies. We also have highlighted the contribution to the safety, human health, and the environment through electric and electronic equipment. 0.2 Reasons for Submission of comments If the current proposed restrictions would be applied, we will not be able to put our products on the EU market without some derogation, exclusion or exemption. As described in Sections 1.1 and 1.2, our products support the social infrastructure of NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) the EU and have a "critical" aspect that differs from general consumer products. Numerous alternative materials have been reported for PFASs that are being restricted, but unfortunately none are applicable for our product applications. As we have shown in some cases in section 1.2.2, if our products cannot be put on the EU market at all, it could have a significant negative impact on the environment and human health in the EU. In order to continue to achieve the protection of the environment and human health that EU REACH aims to achieve, we would like to submit this opinion in the hope that the content of this opinion will be considered. 1 Products handled by this organization 1.1 What are our organization & Examples of products manufactured by its member companies 1.1.1 About NECA NIPPON ELECTRIC CONTROL EQUIPMENT INDUSTRIES ASSOCIATION (NECA) was established in 1964 and promoting the growth of the electric control equipment fields such as Relays, Switches, Sensors, PLC/FA System Equipment and others, Safety Control Equipment. Our website provides further information on our recent news and activities: https://www.neca.or.jp/en/ 1.1.2 Product of NECA <Relays> Relays use electrical signals to open or close contacts, and consist of electric coils and contacts. Variations include solid-state non-contact relays and relays incorporating timers and counters that provide measurement functionalities. <Switches> Switches allow users to directly power on and off system and equipment by hand, finger or foot by opening and closing the contacts to toggle electrical signals. These switches act as an interface between human and machine, allowing the user to take control such as starting up an operation. NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) <Sensors> Sensors that toggle electrical signals or generate an output, by physical contact or non-physical contact based on changes in light or magnetism to detect the presence of an object, its location, color, temperature, or rotational angle. <PLC/FA System Equipment> Programmable logic controllers, programmable display equipment, and FA (Factory Automation) system equipment such as ID systems, image processing systems, and temperature control devices that perform control and monitoring functions based on pre-programmed settings. <Safety Control Equipment> Emergency stop device, safety light curtains, safety relay, safety PLC, are control devices and I/O devices that conform to safety standards, designed for use in control circuits that ensure compliance with safety regulations for equipment and facilities. <Other Control Equipment> Equipment for transmitting electrical signals such as connectors and terminal, display and monitoring equipment such as revolving beacon and panel meters, and other control equipment such as power supply and solenoids for control functions. 1.2 Features of our parts and products 1.2.1 How to be used As described in Section 1.1, our parts and products are mainly assembled into industrial monitoring and control instruments, medical devices including in vitro diagnostic, factory automation to manufacture various type of products etc. typical business sector is, for example, automotive, medical, semiconductor, chemical, research and development etc that we say EEE Specialist equipment,. In addition, the parts and products are applied in business to business and safety and quality requirement are so severe. NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) 1.2.2 Critical for social infrastructures We would like to emphasize strongly that our parts and products are essential in the social infrastructure and industrial automation business. It is shown as several examples in the below. <Case-1: Sensor> Various triggers to monitor and control are essential in industrial factory automation, any infrastructures etc. Various sensors for temperature, position, pressure etc are the key components to detect the triggers. Quality and safety requirements for the sensors are to be robust and secured. <Case-2: Controller with surrounding parts and products> Monitoring and control are essential in industrial factory automation, any infrastructures etc. Various parts such as relay, power supply, programmable logic circuit, breaker etc and various products such as industrial robot, scanner etc are also essential. Quality and safety requirements are also to be robust and secured. 1.2.3 Our B to B customer situation: Low volume of production, long-life, long supply chain Our parts and products are mainly assembled into Industrial monitoring and control instruments and medical device including in vitro diagnostic, we say EEE Specialist equipment, as mentioned before. Their products have the features that are made in small numbers, are produced for long periods without modification or changes and have to be reliable and need long term test for reliability. The instruments would have been replaced typically after 7-10 years or more from the release of the products.1 The supply chains are very long and take time to eliminate restricted substances from the supply chain. 1 Dr Paul Goodman, Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 - Final Report, ERA Technology, 2006 Page 27-34 https://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) Table 1 Table comparison of industrial test equipment with mobile phones2 Table 5-4 Amount of EEE (tons) put on the EU market, per year and product category, "Support for the Evaluation of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Final Report" shows the percentage of category 8 and 9 products is only 3.5 of all amount of electric and electronic equipment (EEE) (tons) put on the EU market (see the below).3 The picture is produced from Table 5-4 Amount of EEE (tons) put on the EU market, per year and product category, Support for the Evaluation of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Final Report, p.147 https://op.europa.eu/en/publication-detail/-/publication/5b807311-9d93-11ebb85c-01aa75ed71a1/language-en 2 Dr Paul Goodman, Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 - Final Report, ERA Technology, 2006 Page 34 Table 2 https://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf 3 Table 5-4 Amount of EEE (tons) put on the EU market, per year and product category, Support for the Evaluation of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Final Report, p.147 https://op.europa.eu/en/publication-detail/-/publication/5b807311-9d93-11eb-b85c01aa75ed71a1/language-en NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) 1.2.4 Exemption for spare (repair) parts are necessary for our users, mainly EEE Specialist equipment manufacturers Spare parts are necessary to guarantee the expected lifetime (more than 20 years) of our users' instruments. Especially since instruments are required high performance and high reliability, we would like to emphasize that the same spare parts are required to supply from our users for long years as mentioned above. According to the principles of "Right to repair" and "Repair as produced", exemption for spare (repair) parts are to be properly considered. 1.2.5 Long development cycle in our users Products of our users, mainly EEE Specialist equipment manufacturers, are required to be highly reliable because they are manufactured for a long period of time without modification. Along with this, long-term reliability tests are required. If there is a certification request, a longer period is required to obtain it. As a result, development cycles are longer compared to other consumer products. An example of development process is below: - Searching of parts and materials: 1-2 years - Reliability test: performance test of the product: 1-2 years - Device design: 0.5-1 year - Develop the production line /buy new production equipment: 1-2 years - Create Technical Documentation: 0.5 year - Training at the production site: a few months - Production management (information to customers): 0.5-1 year - Third-party certification: 1 year without clinical trial a few years or more with clinical trial or customer approvals NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) 1.3 Current status of PFAS applications and alternative technologies Parts and products in NECA are assembled into other products or system in variety types of business field such as shown below: Classification Social infrastructure Industry automation, Process automation, Factory automation Semiconductor manufacturing Automotive vehicle Medical equipment Example Traffic monitoring and control including train and high speed motorway, automated teller machine, automated distribution system, automated ticket gate, analytical instrument, measurement instrument, tele communication, building management system, etc Robot for the automation, automated inspection instrument for something such as PCB, (Printed Circuit Board), equipment and protective system intended for use in potentially explosive atmosphere, monitoring and control instrument for the automation etc To be made input from the business sectors The impact of potential PFAS restriction on the semiconductor section by SIA PFAS consortium is better to understand the examples. (*1) To be made input from the business sectors To be made input from the business sectors (*1) https://www.semiconductors.org/wp-content/uploads/2023/04/Impact-of-a- Potential-PFAS-Restriction-on-the-Semiconductor-Sector-04_14_2023.pdf The examples of application like the table above in NECA's customer are attached in Appendix 1, that includes uses and substitutions of specialist equipment. In addition, the examples of NECA's parts and products are attached in Appendix 2, that includes essential application NECA have strongly requested from NECA's customer. NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) 2 Suggestions and requests from us 2.1 The long grace period and extension are required If the alternatives are become available in the future, a long grace period is required until PFAS become restricted The instruments are made in small numbers, are produced for long periods without modification or changes, have to be reliable and need long term test for reliability. The instruments would have been replaced typically after 7-10 years or more from the release of the products.4 The supply chains are very long and take time to eliminated restricted substances from the supply chain. If the electric and electronic equipment mentioned above cannot use PFAS anymore and PFASs are to be substituted, the long grace period is required in order to test the product to comply with the safety requirements defined with IEC and other safety standards, and obtain the re-certificates according to the requirements. An example of substitution process is below: - Testing of alternative materials: 1-2 years - Reliability test: performance test of the product: 1-2 years - Device design change: 0.5-1 year - Change the production line /buy new production equipment: 1-2 years - Create Technical Documentation: 0.5 year - Training at the production site: a few months 4 Dr Paul Goodman, Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 - Final Report, ERA Technology, 2006 Page 27-34 https://ec.europa.eu/environment/pdf/waste/weee/era_study_final_report.pdf NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) - Production management (information to customers): 0.5-1 year - Third-party certification: 1 year without clinical trial a few years or more with clinical trial or customer approvals As mentioned above, even if an alternative is found, the replacement takes a long time. EEE specialist equipment therefore needs a longer transition period. If " Testing of alternative materials: 1-2 years " and " Reliability test: performance test of the product: 1-2 years " prove unusable to EEE specialist equipment, the process starts over. Then, it is not possible to predict when the replacement will be completed. It is necessary to check the status of alternative materials at regular intervals and extend the transition period if no alternative materials have been found. Our equipment also uses general electronic circuit components (see application information in Japan 4EE Opinion COM Part 21, No. 4543, and comments to be submitted). In other words, it may use common parts with general consumer EEE. In this case, even if a replacement part for general consumer EEE is found, it may not be applicable as a replacement part for EEE specialist equipment. As mentioned above, performance and reliability requirements are high for EEE specialist equipment, so even if you try to apply replacement parts for general consumer EEE to EEE specialist equipment, there is a possibility that they will not pass various tests. In that case, too, the extension of the transition period is necessary. 2.2 The derogation of spare (repair) parts are required The exclusion of the spare (repair) parts which are used for EEE Specialist Equipment placing on the EU market before the entry into force is required. As explained in the 1.2.4, EEE specialist equipment requires the same spare parts for the life of the product as when first evaluated. If spare parts were not derogated and its equipment had already been in EU market, to repair that equipment after entry into force, only spare parts will become to be design changed. These changes to spare parts can affect to some conformance of related directives and regulations for its EEE. It means the re-evaluation is necessary. The evaluation process is equivalent with that of new products. It would be against the EU green objectives, as expressed in the EU Circular Economy Action Plan, to prematurely end the service life. It is not feasible and is not efficient. Therefore, the derogation for spare(repair) parts are allowed with EU RoHS Directive. It is also related to "Right to repair" and "Repair as produced" principles. We hope the derogation for spare(repair) parts in REACH Regulation would be set. NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) 2.3 Reasonable implementation of Reporting Requirement for EEE Specialist Equipment in case of exempted Although reporting requirements have been proposed for PFASs used in exempt applications, it is recommended that existing mechanisms be used as several similar reporting requirements have already been implemented in other regulations. It also reduces the administrative burden. For example, gases within the PFAS group are subject to the F-gas Regulation, which already has reporting requirements. (https://climate.ec.europa.eu/eu-action/fluorinated-greenhouse-gases/f-gas-portalhfc-licensing-system-quota-allocation-authorisation-and-reporting_en) PFASs are widely used in EEE Specialist equipment. SVHCs in articles are collected in order to meet the obligation of Article 33 of REACH regulation. Information on the uses of chemical substances which are classified with CLP regulation is also collected for chemical products and products which are subject to MDR, in order to meet the obligation of communication on hazardous substances. The following describes the current status of information transmission through the supply chain regarding PFASs. Not all PFASs are designated as SVHC or classified under the CLP regulations. Therefore, we have not obtained the information on use of PFASs. The minimum threshold specified in the Regulations is 0.1%. We cannot obtain the information on uses as the units of ppb as proposed. Our supply chains are very long and take time to obtain the information on the uses from the supply chain. As mentioned above, it is very difficult to obtain information on all PFASs. However, regarding SVHC and CLP classified substances that have been recognized as hazardous or toxic, the information can be collected through the existing communication flow, so this is the most feasible method. PFASs that are found to be harm or toxic will automatically follow the above information transfer flow and will be transferred to the EU regulatory authorities. NECA as of September 18, 2023 Nippon Electric Control Equipment Industries Association ( NECA ) 2.4 Reference Materials should be excluded from the scope As proposed in this consultation, reference materials should be excluded from the scope. Reference materials and substances used in scientific research and development are necessary for the analysis of PFAS. Without these, precise analysis is not possible. Therefore, reference materials for its analysis should be excluded from the scope. Appendix 1 Uses and substitutions of Specialist Equipment This document is the appendix 1 of the general comment to the Restriction report on Per- and polyfluoroalkyl substances (PFAS) From NIPPON ELECTRIC ASSOCIATION (NECA) CONTROL EQUIPMENT INDUSTRIES submitted on 18. September 2023 1 / 111 Table of content The characteristics and functions of PFAS ............................................................................. 3 Summary.................................................................................................................................. 3 Chemical resistance ............................................................................................................... 3 Ozone resistance .................................................................................................................... 3 Repellency from water and oil / non-adhesion.................................................................... 4 Heat resistance ....................................................................................................................... 5 Electric insulation ................................................................................................................... 5 Low friction, self lubrication.................................................................................................. 6 Gas barrier properties/Gas permeation properties............................................................. 7 Low refractive index ............................................................................................................... 9 Weatherability ......................................................................................................................... 9 Durability ................................................................................................................................11 Resistance to creep / Compression set ..............................................................................11 Uses of PFAS in Specialist Equipment .................................................................................. 13 Summary................................................................................................................................ 13 Electric wires and insulation ............................................................................................... 13 Heat shrink tubing ................................................................................................................ 19 Sealing materials .................................................................................................................. 19 Plumbing................................................................................................................................ 28 Valves ..................................................................................................................................... 37 Pumps .................................................................................................................................... 45 Coating/Lining....................................................................................................................... 46 Membrane filters ................................................................................................................... 63 Optical coating ...................................................................................................................... 68 Heat medium ......................................................................................................................... 79 Lubricating oil ....................................................................................................................... 79 Medical uses.......................................................................................................................... 83 Others..................................................................................................................................... 91 2 / 111 The characteristics and functions of PFAS Summary PFASs have many functions. The characteristics and functions of PFAS which are mainly used in Specialist equipment are described in this section. PFAS has excellent properties such as, chemical resistance, electric insulation, heat resistance, repellency from water and oil, non-adhesion, weatherability, and others. PFASs are used where multiple of these properties are required simultaneously. We recognize that the ability to provide these various properties in a single material is the most important property of PFAS, and at present we do not have information on any other substance with this function other than PFAS. Chemical resistance Fluoropolymers are composed of CF bonds, one of the strongest single bonds, and exhibit superior resistance to solvents, acids, alkalis, etc. compared to other general-purpose resins. Table 1 Chemical resistance of fluoropolymers 1 Priority from general material "D" A+ABCD Product Chemical resistance Polar Non polar Alkarine Acid solvent solvent Amine Fuel Oil Fluoropolymer Fluoropolymer films PTFE A+ A+ A+ A+ A+ A+ A+ Fluoro coatings PFA Polymer additives FEP A A A A A A A CPT ETFE EFEP A A A B B A A PCTFE Fluoroelastomer B B C A B A A Fluorinated oil A+ A+ A+ A+ A+ A+ A+ Ozone resistance Ozone is known to degrade plastic materials in two ways: A: Substances with double bonds (C=C) in their structures (such as natural rubber, chloroprene rubber, butadiene rubber, etc.) undergo decomposition in which ozone reacts with the double bonds to produce ketones, when they come into contact with ozone. B: When ozone exists in water, peroxy radicals are generated. Non-fluorine materials (eg polyethylene, polypropylene, etc.) deteriorate even if they do not have double bonds. Fluoropolymers does not have decomposition pathways such as A and B even if it comes into contact with ozone, so it can be used for a long time without deterioration. 1 https://www.daikinchemicals.com/solutions/technical-challenges/chemical-resistance.html Last accessed on 8 September, 2023 3 / 111 Table 2 Comparison of ozone resistance properties of plastics Thermoplastic resin Ozone Resistance Soft vinyl chloride PVC Rigid vinyl chloride PVC Vinylidene chloride resin PVdC ABS ABS Polyethylene PE Nylon N Acrylic resin PMMA Fluoropolymer resin PTFE Phenolic resin PF Melamine resin PVC Furan resin FF Epoxy resin EP Unsaturated polyester resin UP Repellency from water and oil / non-adhesion Since the fluoropolymers have a small polarizability, the intermolecular force is small. Because of its characteristics, fluoropolymers have repellency and non-adhere properties on the surface. In general, the repellency from various liquids is evaluated by the contact angle, and the larger the contact angle, the higher the repellency. Contact angle Figure 1 Contact angles with water Adhesion energy refers to the amount of work required to pull a liquid contacting a solid away from the solid. The larger the contact angle, the smaller the adhesion energy. It means that a 4 / 111 liquid in contact with a small adhesion energy solid easy to separate from the solid.2 Table 3 Surface properties of various plastics and metals Material name Contact angle with water (o) PTFE 114 FEP 115 Silicone resin 90~110 Paraffin 105~106 PE 88 PCTFE 83 PA 77 Phenolic resin 60 Copper(electropolishing) 9.6 Aluminium(electropolishing) 4.6 Adhesion energy (dyn/cm) 43.1 42.0 47.8~72.7 52.7~53.8 75.2 - 97.7 109.0 144.2 145.0 This characteristic is sometimes called "mold releasability". It can also be expressed as antifouling because it does not easy to adhere. Heat resistance Fluoropolymers have high heat resistance as follows. They have higher heat resistance compared to other general-use resins. Table 4 The heat resistance of Fluoropolymer 3 Heat resistance : maximum operating temperature (C) PTFE 260 Fluoropolymers PFA FEP ETFE 260 205 150 PCTFA 120 PVdF 120 Other general-use resins PP PVC 100 60 Electric insulation When the dielectric constant is low, the insulation in electrical components can be made thinner, leading to downsizing and weight reduction of the equipment. In applications where downsizing and weight reduction are necessary, it is an essential feature. 2 Japan Fluoropolymers Industry Association(2020)Fluoropolymers Handbook14th edition. Page 34 3 DAIKIN INDUSTRIES, LTD. (2009)Daikin Fluoropolymers HandbookPage 4 5 / 111 Table 5 The dielectric constants of various resins Dielectric constant Dielectric constant PTFE PVC 46 Fluoropolymer FEP PFA 2.1 Non-fluoropolymer PEEK TPI (Thermoplastic Polyimide) 3.24.5 2.83.2 ETFE 2.32.8 Polyolefin 2.34 Fluorine rubber FKM FEPM 34 2.53.5 Non-fluorine rubber Silicone rubber EPDM 3.210 2.53.5 Low friction, self lubrication Friction coefficient of fluorine resin is lower than that of other resins. It is because polarizability (Mobility of electrons in an electric field) of C-F bonding is low (0.68) and the intermolecular force is weak. (Reference: polarizability of C-Cl bonding is 2.59) 4 Table 6 Comparison of friction coefficient among PTFE and other materials5 Types of plastic Plastic / Plastic Plastic / Steel Steel / Plastic PTFE 0.04 0.04 0.10 PE 0.10 0.15 0.20 PS 0.50 *) 0.30 0.35 PMMA 0.80 *) 0.50 *) 0.45 *) *) indicates occurrence of stick-slip motion. Measurement condition: Bowden-Laden type measurement equipment, load: 9.8-39.2N, sliding speed: 0.01cm/s Plastic/Steel indicates sample material/pin material PE: polyethylene PS: polystyrene PMMA: polymethylmethacrylate As an example of low friction, Table8 shows friction coefficient of PTFE. Table 7 Comparison of static friction coefficient among PFA, PTFE and FEP6 Type Coefficient of static friction ASTM test method - Measurement condition Against polished steel Unit PFA PTEF FEP - 0.05 0.02 0.05 One of the characteristics related to friction is "self lubrication". The molecules of PTFE separate from molding of PTFE due to friction. The molecules in crystals of PTFE separate easily because intermolecular forces are weak. PTFE moves and attaches to the friction mating surface and 4 Japan Fluoropolymers Industry Association(2020)Fluoropolymers Handbook14th edition. Page 9 5 Japan Fluoropolymers Industry Association(2020)Fluoropolymers Handbook14th edition. Page 24 6 DAIKIN INDUSTRIES, LTD. (2009)Daikin Fluoropolymers HandbookPage 53 6 / 111 generates friction between them. It lowers friction coefficient. 7 Gas barrier properties/Gas permeation properties Fluoropolymer film are less steam permeability. steam permeability (g/m2/d) Figure 2 The degree of steam permeability 8 7 Japan Fluoropolymers Industry Association(2020) Fluoropolymers Handbook14th edition. Page 24 8 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 109 7 / 111 Fluorine elastomers are less atmospheric (nitrogen, oxygen) permeability. Table 8 Comparison of gas permeability of elastomer9 Material Temperature degree He H2 O2 N2 Celsius Vinyl methyl silicone 25 rubber VMQ 50 N/A 400 400 200 570 500 280 Ethylene propylene 25 rubber EPDM 50 16.5 5.90 N/A N/A 46.6 13.7 Perfluoro-elastomer FFKM 25 10.3 8.25 2.5 8.1 Styrene butadiene 25 17.5 30.5 13 4.8 rubber SBR 50 42 74 34.5 14.5 Vinylidene fluoride fluororubber binary FKM 25 2.95 4.6 1.0 0.8 Vinylidene fluoride fluororubber Ternary FKM 25 2.64 4.13 1.7 0.7 Chloroprene Rubber 25 CR 50 nitril-butadiene 25 rubber Mid-high NBR 50 nitril-butadiene 25 rubber High NBR 50 butyl rubber 25 IIR 50 10,/,sec,atm 10.3 3.0 0.89 N/A 28.5 10.1 3.55 9.32 12.1 2.94 0.81 23.4 33.7 10.5 3.58 5.2 5.42 0.73 0.18 14.2 17.0 3.5 1.08 6.4 5.5 0.99 0.25 17.3 17.2 4.03 1.27 Table 9 Gas Permeability of FEP film10 Property N2 O2 Gas permeability H2 Gas Permeability coefficient CO2 CH4 C2H4 Water-vapor permeability Water Absorption Standard Test method ASTM D1434 JIS Z0208 ASTM D570 CO2 1600 1550 79.2 183 28.7 94 195 CH N/A N/A 3.3 N/A 3.9 0.6 1.6 0.4 19.5 2.5 56.5 9.8 23.5 N/A 67.9 5.67 N/A 22.4 3.94 0.6 14.3 3.2 Unit /satm g/24h 24h C2H2 N/A N/A C3H8 10000 or more 91.2 246 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 18.9 26.9 68.3 78.3 8.25 11.2 19.8 33.1 1.28 N/A 5.82 FEP film 12010-10 37010-10 1,08010-10 97010-10 6610-10 4410-10 1.6 <0.01 9 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 78 10 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 78 8 / 111 Fluoropolymers permeate small molecular gases, such as oxygen and nitrogen, conversely, large molecular gases do not permeate. Fluoropolymer properties are used in permeate membranes for measurement and analysis. Table 10 Comparison of gas permeability of various materials11 Gas N2 O2 CO2 CH4 CH3 CH C2H4 FEP 1.210-8 3.710-8 9.710-8 0.6610-8 0.6610-8 0.1110-8 0.4810-8 Gas Permeability PTFE 1.110-8 3.210-8 8.910-8 Low Density Polyethylene 0.7410-8 2.210-8 9.610-8 2.210-8 5.210-8 7.210-8 Temperature: 25 degree Celsius(77F) Units: cm3 (ST P) cm/cm2atm Low refractive index Amorphous fluoropolymer resin has high transmittance. This is utilized for optical components and optical fibers. Wavelength (nm) Figure 3 Comparison of transmittance 11 Weatherability Fluoropolymer resin has high weatherability and can be used outdoors. It does not react to sunlight such as ultraviolet rays. It is not susceptible to oxidizing effects of atmospheric oxygen and other substances (see "chemical resistance"). It can be used in a wide temperature range from low to high (see "heat resistance"). It has high water repellency and does not absorb 11 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 80 9 / 111 water, so it is not affected by humidity changes. It can be said that fluoropolymer resin has high weather resistance because it has the above points. Table 11 Fluoropolymer resin weatherability comparison 12 Fluoropolymer resin PTFE PFA FEP ETFE PCTFE Weatherability Excellent, Good Not very good Needs attention Not good PVdF General resin PP PVC Regarding the graph below, it can be seen from the accelerated weatherability test with the Sunshine Weather Meter that the gloss retention rate decreases by no more than 10% even after 4000 hours of exposure. 13 Fluoropolymer resin paint Gloss retention rate of paint film (%) Acrylic silicone paint Urethane paint Exposure time by weather meter(h) Figure 4 Accelerated weatherability test of paint 12 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 4 13 https://www.kyoeishoji.co.jp/business/chemical/fusso_toryo.html translated from the document in Japanese. Last accessed on 21 July, 2023 10 / 111 Tensile strength (MPa) Figure 5 Outdoor exposure test Comparison of tensile strength between ETFE and other materials 14 Durability It means that it can be used for a long time. Due to its high chemical resistance and high weatherability, PFAS can achieve high durability. Resistance to creep / Compression set When a constant load is applied to a polymeric material, creep occurs, in which deformation progresses over time. Similarly, compression set occurs where the deformation does not recover when the force is removed. Both properties are known to be correlated. When rubber materials are used in elastic applications such as packings or diaphragms, it is required to minimize the effects of both properties. Experimental examples of "30% creep time (Hour)" for major rubber materials are shown below. Creep is known to be worse at higher temperatures, Experiments have shown that FKM and silicon exhibit good properties. Table 12 Stress relaxation and creep properties of various vulcanized rubbers NR SBR CR NBR IIR FKM Silicon 50 degree Celsius 190 1250 4200 3900 70 degree Celsius 103 203 550 380 100 degree Celsius 3.8 14 45 41 2.7 1650 120 degree Celsius 7.4 12.2 305 1550 150 degree Celsius 180 190 Quoted from the journal of "the Society of Rubber Science and Technology, Japan", 1960(Vol33), P882-892, "Stress relaxation and creep properties of various vulcanized rubbers". 14 https://www.taiyokogyo.co.jp/feature/etfe_film.html translated from the document in Japanese. Last accessed on 21 July, 2023 11 / 111 Examples of compression set test results are shown below. In general, it is difficult to quantitatively compare materials because the measured values differ depending on the compounding and hardness of the rubber. Here, the compression set of the materials was compared by comparing the minimum value of each material in the database. FKM and silicon showed relatively good properties, showing the same tendency as creep. Table 13 Compression set of each material (The minimum value) NR SBR CR NBR IIR EPDM FKM Silicon Compression set JISK6301 100 degree Celsius70h Min 20 Min 23 Min 9 Min 23 Min 11 Min 6 The minimum value of each material was quoted from the data described in "Material Database / Organic Materials" (1989), The Nikkan Kogyo Shimbun". 12 / 111 Uses of PFAS in Specialist Equipment Summary PFAS are a very important group of substances for Specialist Equipment, which depends on these uses to maintain safety, as they are highly effective in chemical resistance, Repellency from water and oil, and electric insulation. PFAS polymer resins are two to ten times more expensive than other commodity plastics. There is no use other than where the equipment does not work without the use of PFAS. General electronics components are not covered in this document. However, since our equipment also uses common electronic circuit parts, we also use parts common to information equipment and general consumer EEE. For usage and non-substitutable information for such parts, please refer to Japan 4EE Opinion RCOM21, No.4543 and additional Opinion Information and Non-Substitutable Information to be submitted in September 2023. Semiconductors are also used in our products. Many PFASs are used in semiconductors and semiconductor manufacturing equipment. Comments on most of the items in this section have been submitted by industry associations that specialize in the respective items. We hope that dossier submitters consider the manufacturer's opinions. Electric wires and insulation An electric wire is a linear member for transmitting electricity. Metal, which is a good conductor, is used for the part that transmits electricity, and plastic resin that has electric insulation is used around the wire in order to block the influence on anything other than the transmission destination of electricity. Conductor Figure 6 Sheath Polyvinyl chloride is generally used for covering parts where plastic resin is used, which is called as sheath, but PTFE, PFA, FTPE, etc. are selected depending on the suitability of use and electric insulation requirements. Since these are more expensive than polyvinyl chloride, they are used only when it is difficult to use other materials such as polyvinyl chloride. PFAS functions required by PFAS wires and availability of alternatives Wires using PFAS for coating have high electrical insulation when the coating is thin (100 m or 13 / 111 less). PFAS also has a high heat resistance of 150-200C. In addition, PFAS wires can be used even when there are chemicals around the device because PFAS has chemical resistance. Examples of devices equipped with electric wire and insulation: Medical cables of probe cable for ultrasound diagnostic equipment Photo 3 Photo 1 Photo 2 Cross-sectional view of one coaxial wire Photo 4 Figure 7 The ultrasonic diagnostic device is shown in Photo 1 and consists of an image analysis unit and a cable with a transducer. The cable with transducer shown in Photo 2 is composed of about 200 coaxial wires in order to transmit and receive about 200 signals. The inside of the red circle cable in Photo 2 is as shown in Photo 3. Photo 4 shows a cross-sectional view of one of Photo 3. The performance required for these coaxial wires is (electric insulation / low dielectric constant), heat resistance, and extrusion suitability. PFA/FEP is used as a material that satisfies these three elements. Table14 shows the comparison results with the alternative candidate material PEEK. In order to obtain a diagnostic image with high accuracy, the attenuation of coaxial wire must be 2 dB / m or less in terms of the size shown in Table14, and the required performance is not satisfied unless PFA/FEP is applied. In order to satisfy the attenuation, it is necessary to reduce the capacitance, and for this 14 / 111 purpose, the dielectric constant must be 2.1 or less. The cross-sectional view of one coaxial wire is shown in Photo 4, and the red arrow part is the insulating layer and the green arrow part is the outer skin layer. Both layers require thickness control of 0.05 mmt or less, and PEEK cannot be controlled, especially for the outer layer because it does not stretch. In order to evenly cover the outer layer without destroying the shield layer, stretching is necessary. PEEK meets only heat resistance requirements. Table 14 Comparison with alternative candidate material PEEK Board terminals of Luminance meter The luminance meter uses PFAS for the optical sensing substrate, which handles currents as extremely small as a few pA (10-12 A). Since the extremely small current output from the optical sensor is measured and used, even if a tiny amount of current leaks out from the original path onto the substrate, it is a critical error factor. Since leakage current values must be controlled to be sufficiently smaller than pA units, electronic components are wired floating off the substrate, as shown in the following figure 8. However, since it is inevitable that the soldered part comes in contact with the substrate, a PTFE terminal with high insulation properties is used as a prop for connection (connection prop), and soldering is performed there to ensure high insulation to the substrate. Then, leakage current generation is controlled. Without PTFE terminal, the product doesn't satisfy its function. Figure 8 15 / 111 In circuits that handle very small currents at the several pA level, leakage current must be controlled as described above, and the connecting pillar must have very high insulation (about 1015) under all environmental conditions (temperature, humidity, etc.). Surgical power cord Silicone case External Figure 9 Figure 10 Adhesive tape The surgical treatment tool shown in the above figure has a structure in which the tip of the treatment part can be rotate. The power supply cord twists according to the rotation of the treatment part. Since the resistance and hardness of the rotation of the tip treatment tool due to this twist greatly hinder the operation of the surgeon, it is essential to maintain the flexibility of the cord in surgical treatment tools especially which need delicate operation. It is necessary to maintain electric insulation between each bundled cord, but the flexibility is not maintained when it becomes thicker. So it is essential that each cord is covered with PFA. In addition, since surgical devices conduct high-frequency currents, they are affected by the capacitance between each cord. In addition to suppressing changes in capacitance due to changes in the position of the cord internally, the suppression tape for regulating the position of each cord must have flexibility with the function of preventing the increase of capacitance between cords by autoclave, which is a sterilization process, and it is essential to be EPTFE. RF- generators Inside Figure 11 16 / 111 RF- generators electrical insulation of patient treatment circuit to mains and other electrical circuits [RF = radio frequency current] RF- generators used in the transformer for wire insulation so it is inside the generators . It is used in wire and tubes.Electric insulating and non-adhesion are required. All electrical tests according to IEC 60601-2-2 have to be repeated. It is a high risk that leakage current limits cannot be kept PI and PEEK is not flexible enough. PET chemical resistance is to low, not sufficient heat resistance. US(Ultra Sonic)- generators also used it. Cable for Sapphire Capacitance Diaphragm Gauge The components use electric insulation with PFAS. Temperature sensor for control Heater board connection cable and thermistor There is no fluorine-free material with equivalent heat resistance. 17 / 111 thermal insulation cap thermal insulation case ->Contains Fluororubber(FKM) Sensor <--> Board connection cable ->Sheath, insulator, etc. contain Perfluoroalkoxy alkane(PFA) Temperature sensor for control ->Heat shrink tubing, cable coating, etc. contain Perfluoroalkoxy alkane(PFA,PFE) Heater board connection cable and thermistor ->Thermistor heat shrink tubing, cable coating, etc. contain Perfluoroalkoxy alkane(PFA,TFE,PTFE) Figure 12 Temperature sensor (thermocouple) A thermocouple is a temperature sensor that measures using the principle that a thermoelectromotive force is generated by connecting the tip of a metal wire made of different materials and the temperature difference between the tip and the other end. Temperature sensors can measure a wide range of objects, including acids, alkalis, and organic solvents, and can also measure a wide range of temperatures, including applications that measure chemicals at 100C or higher. The thermocouple wires are coated with FEP and PFA to ensure accurate measurement without negative effects from chemicals or high temperatures. There is no material other than fluoropolymers that combines chemical resistance and heat resistance to realize such applications, and it is difficult to replace them. 18 / 111 Temperature measurement (connection) part Coating Wire Coated temperature sensor wire Figure 13 Heat shrink tubing By putting a thin and long object to be covered in a tube, heating it, and shrinking the tube, the object is covered. It prevents parts from coming off or falling off, and strengthens the covered part. Fluoropolymer resin heat-shrink tubing is thin but has high electric insulation performance. PTFE and PFA are used as fluoropolymer resins. Functions of PFAS required by heat-shrinkable tubing and availability of alternatives: Fluoropolymer resin heat-shrink tubing is thin but has high electric insulation performance. It can be used in applications where there is not enough space for electric insulation, and there is no alternative material available for applications that require tight spaces. Examples of the products which incorporate heat shrinking tubes: Thermistor protection for Sapphire Capacitance Diaphragm Gauge Components corresponding to a heater operating temperature of MAX 250C. For the picture of this products, please see the explanation in electric wires and insulation. Fluoropolymer resin is used in the heat-shrinkable tube to protect the thermistor. There is no fluorine-free material with equivalent heat resistance. Sealing materials Parts description: Packings, gaskets, and O-rings Packings and gaskets exist to connect and seal by placing/placing them between parts. As an example, they are used in piping and pipe connections. Gases and liquids that pass through pipes leak out through the smallest gaps, and packing gaskets exist to prevent this. Packing in the narrow sense is used for power system parts, and those used for non-moving parts are called gaskets. Various innovations have been made in molding and realizing 19 / 111 functions, such as spiral gaskets made of alternating layers of thin metal strips and PTFE sheets, and wrapped gaskets made of 0.4~0.8 mm hot PTFE, covering gaskets of metal or other materials. Those with a circular/round cross section are called O-rings. In addition to PTFE, fluoropolymer rubbers such as FKM and FFKM are also used for this application. Figure 14 Packings, gaskets, O-rings Bearings A bearing reduces friction between two parts to make movement smoother. Bearings are classified into radial bearings, thrust bearings, and linear bearings, depending on whether rotational or linear motion is involved. A bush is also a type of bearing. Fluoropolymer bearings such as PTFE have a low coefficient of friction and can maintain a constant torque within various tolerances, while minimizing rattling and noise. In particular, PTFE must be used for bearings near chemical fluids such as acids, alkalis, organic solvents, and ozone, and for food contact applications, where oil is not preferred. Rotating shaft Brush Case Turbine Water or Air Figure 15 Bearing used for the rotating shaft sliding part of the sensor cleaning brush Sealing tape Sealing tape, made of PTFE material, is an adhesive tape used to secure parts within equipment. It is employed to fasten parts that could pose safety risks if dislodged, as well as to seal mounting parts. Additionally, the tape serves as a filler to address gaps in the joints or 20 / 111 connections of pipes for flowing liquids or gases, such as water pipes, air pipes, and hydraulic pipes. Notably, the tape can establish liquid- or gas-tight connections with tapered pipe threads by directly filling the voids between the threads. Figure 16 The functions of sealing materials of PFAS and alternatives Functions of PFAS Required by Sealing Materials and the Feasibility of Alternatives to PFAS Required Functions for Sealing Materials Liquids and gases flowing in pipes, or near parts, often consist of strong acids, alkalis, or organic solvents. Therefore, the sealing materials used must be resistant to these chemicals. Fluoropolymer is highly resistant to such chemicals, and additionally, it is ozone-resistant, making it an ideal choice when ozone is present in the piping. If the liquid or gas in the piping, or the equipment itself, operates at high temperatures, PTFE or PFA are good options due to their high heat resistance of up to 260C, a limit higher than other resins. FFKM and FKM rubbers also exhibit high heat resistance, withstanding temperatures up to 250-300C. For applications where sealing materials, such as gaskets, are used on sliding surfaces, where lubricating oil is unsuitable (particularly in contact with food), or where play and noise must be avoided, sealing materials must also possess low friction and self lubrication properties. In the restriction report on seal tape, paste-like sealing materials are mentioned as alternative materials. However, if these sealing materials contain hydrocarbon substances, reactive functional groups may decompose. This could pose a risk of contamination in the surrounding area due to the produced decomposition products. For sealing tape used for equipment operating in clean environments, where such contamination is unacceptable, paste-like sealing materials cannot be used as alternatives. 21 / 111 As a sealing material that combines outstanding chemical resistance, ozone resistance, heat resistance, water and oil repellency, low friction, self-lubrication, and cleanliness, there is no substitute for fluoropolymers. The substitution of fluoropolymers with other materials poses a significant challenge. Non fluorine elastomers might be considered as potential replacements for fluorine rubbers like FKM rubber. However, their heat resistance, low friction, and chemical resistance do not measure up to those of fluorine-rubbers like FKM rubber. Therefore, substituting fluorine -rubbers with non fluorine elastomers is unfeasible. Examples of the products which uses sealing materials Pressure Transmitter Pressure transmitters are measuring instruments mainly used in factories and plants. It measures pressure for process fluids such as liquids, gases and steam and outputs analog or digital signals corresponding to the measurement results. It is also used to measure flow rate and liquid level based on measured pressure. The process fluid to be measured has various characteristics such as temperature, pressure, and properties. If the sealing performance is not maintained, not only correct measurement results not be obtained, but the factory or plant may stop. In addition, if the process fluid is high temperature, extremely low temperature, or toxic or corrosive, the outflow of the fluid may cause great damage to the surrounding environment and workers, so the sealing performance is very important. Many sealing materials that use PFAS materials have excellent heat resistance and chemical resistance, and it is considered difficult to replace them when considering the above safety assurance. O-Ring - It is used for sealing the mating part of the product. Figure 17 Wetted O-RING Gasket - Seal a product and pipe fittings. Fluid leak prevention. 22 / 111  Collar Gasket Gasket usage example Figure 18 Adjustment seal between two prisms for projector (PTFE adhesive tape) A projector is a device that uses light to project an image. They use high intensity light to form a clearer image. High-intensity light generates heat, so heat-resistant components are required. In addition, the device requires very delicate adjustment to form an image. To create the gap for adjustment, PTFE tape is used, which has high heat resistance, high chemical resistance, and excellent sliding properties. The prism unit for the projector consists of two types of prisms, and PTFE tape is used between the two prisms to allow position and spacing adjustment after manufacturing. PTFE tape is used with the adhesive to bond around the optical path between the two prisms to prevent dust, and the water-repellent effect of PTFE allows air to pass through but prevents water from entering. 23 / 111 Since projectors are used indoors and outdoors, they must be able to withstand temperature changes. The dimensions of glass change slightly with temperature, but if a tape with low slipperiness is used, the lens will be damaged by friction. So, slipperiness is necessary. Slipping between the tape and the prism glass prevents the prism glass from being scratched when the prism posture is adjusted (assembly process) or when it is vibrated from the external environment (during projector movement or transportation vibration). There is no other material other than PTFE that has heat resistance, chemical resistance, and excellent sliding properties. PTFE tape is used between two types of prisms Figure 19 Image of light path inside the projector Required specifications Environmental humidity 40 degree Celsius/90% Heat resistance: about 100 degree Celsius (GB lasers, laser phosphors, and xenon lamps are used as light sources, resulting in high temperatures inside the equipment. Higher brightness requires more light sources, resulting in higher temperatures inside the equipment. Therefore, higher temperature heat resistance is required. Without heat resistance, the tape would fire or emit smoke.) Chemical resistance/ Organic solvent resistance (IPA, ethanol, acetone, etc.) (Organic solvents are used in the production process, especially for cleaning prisms. Because PTFE tape is bonded to the prism, the tape must also be chemical resistant.) High sliding properties /Low friction properties static friction coefficient Approx. 0.12 Polyester mesh cloth with PFAS coating is placed at the air outflow inlet and outlet in the lens 24 / 111 barrel, which changes in volume due to lens focusing and zooming. By sealing with the cloth, it allows air to pass through but prevent water and dust from entering the barrel. Junction unit for vacuum environment / O-ring for seal for air and vacuum environment Optical Junction unit for vacuum enviroment is used for a photoelectric sensor that enables detection inside a vacuum chamber by transmitting light from a fiber amplifier through a fiber unit. The optical coupler is provided with sealing ability to pass the detection light through the wall of the vacuum device. The O-ring for sealing are made of fluorine rubber to keep high temperature , high seal and high cleanliness VACUUM CHAMBER Enlarged view VACUUM CHAMBER Junction unit Figure 20 Optical junction unit for vacuum To keep high temperature, high seal, and high cleanliness in a vacuum environment, materials other than fluorocarbon rubber are not appropriate. O-rings are used as sealing parts to prevent external leakage at joints between different parts. Mass Flow Controller / Mass Flow Meter O-rings are used as sealing parts to prevent external leakage at joints between different parts. 25 / 111 cross section Example of use in joints between fitting parts and mass flow controllers Example of use for joints between flange parts and body parts Figure 21 Mass flow controller usage example FKM is used for various gases with excellent heat resistance, chemical resistance, ozone resistance, etc., especially when using flammable oxygen gas, it is used due to its high heat resistance and ozone resistance, and the alternative product is a special rubber material, but it becomes a fluorine-based rubber material and the use of fluorine-based substances is unavoidable. If fluorine-based materials are not used, safety is significantly impaired. endoscope reprocessor The endoscope reprocessors use a variety of chemical solutions such as acids, alkalis, and alcohols to clean and disinfect the endoscopes after use. Some of these solutions may cause health hazards such as chemical burns if they come into direct contact with the human body, and sealing materials in the endoscpe reprocessor are required to have chemical resistance to withstand these chemical solutions and prevent leakage. Therefore, fluoropolymers such as PTFE, FKM, FFKM, and FEPM, which have high chemical resistance to various chemical solutions, are used for sealing materials such as packing, gaskets, O-ring and sealing tape. Other substances such as EPDM and silicone are not sufficiently resistant to these solutions, especially the peracetic acid used for endoscopes disinfection, because these substances deteriorate in a short period of time. Therefore, it is impossible to substitute other substances. 26 / 111 Endoscope O-ring Figure 22 A medical device that is inserted into the body through the oral cavity to observe and treat the inside of a lumen. FKM is necessary because the O-ring provided in the sliding part must have chemical resistance and low friction. Chemical resistance is a property necessary for sterilization, disinfection, and cleaning after use to prevent infection. As a sterilization method, there is a method using gas such as EOG or hydrogen peroxide, and the sterilization gas penetrates the interior of the product, so chemical resistance is a necessary characteristic even for internal parts. The sterilization methods that can be used are limited depending on the region, and it is not enough for a product to be compatible with just one, but it is necessary to have resistance to all sterilization methods. There is no material with chemical resistance equivalent to that of FKM and low friction. Computed Radiography (CR) for Non-Destructive Testing CR generates an X-ray image by converting the X-ray information recorded on an imaging plate (IP), a type of X-ray detector used in X-ray photography, into an electrical signal by exciting it with a laser beam. The durable life of a CR is about 6 years. In order to achieve this, it must be durable enough to withstand 540,000 times of IP conveyance (calculated from the assumed frequency of use of CR). In order to achieve this durability, the sliding and wear resistance of PTFE are essential, and there is no material that has the same sliding and wear resistance as PTFE. 27 / 111 IP Figure 23 Plumbing Plumbing is any system that convey fluids or energy for any application. Pipes, tubes, joints, fittings, are used for plumbing. Fluoropolymer resins, such as, PTFE, PFA, PVDF, are used. Some international standards mention uses of fluoropolymer resins for plumbing. 15 Tubes (not heat shrink tubes) Tubes are used for convey fluids to the places. Figure 24 Joints / fittings Joints / fittings are components to connect tubes to units and/or tubes to tubes. Figure 25 15 Example of international standards: ISO 12039:2019 mentions that the sampling line shall be made of PTFE, PFA. 28 / 111 The functions and alternatives which plumbing requires: The material of plumbing is determined by the types of fluids flowing through tubes. Fluoropolymers can be used as piping for fluids in the temperature range of -10C to 200C (PTFE) and about -40C to 160C (PFA), including acids, alkalis, organic solvents, ozone, and oils. Fluoropolymers (PTFE, PFA, PVDF) are the only plumbing materials that can be used when the fluids of flowing the tubes meets one or more of these characteristics. Fluoropolymer resins are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of chemical resistance/ cleanliness, repellency from water and oil, and heat resistance. Examples of the products which incorporate plumbing: Magnetic Flowmeter An Electromagnetic Flowmeter is a type of flow meter that applies a magnetic field in the perpendicular direction to the flow of the measured fluid. As a result of the flow and the magnetic field, an electromotive force is generated in directions perpendicular to both the flow and the magnetic field. This electromotive force is extracted by a pair of electrodes, and the output signal is sent to a converter. The electromagnetic flow meter is a flow meter that applies Faraday's law of electromagnetic induction to moving objects. Electromotive force (E) Excitation current Excitating coil Lining Velocity: V Measurement fluid Pipe Electromotive force: E Electrode Pipe inner diameter: D Magnetic field (Magnetic flux density: B) Figure 26 The resin lining, known as lining, is applied to pipes (metal piping), and materials such as PFA and PTFE are used. The purposes of this lining are as follows: Electrical insulation: The lining ensures electrical insulation between the measured fluid and the electrodes or the pipe, preventing electrical short-circuiting of the signal electromotive force. 29 / 111 Chemical resistance: The lining provides resistance to chemical substances such as acids and alkalis when the measured fluid contains them. This prevents corrosion and degradation caused by the fluid's characteristics and the environment, thereby improving the accuracy and reliability of the measurement. Wear protection: The lining plays a role in protecting the pipe from internal friction and impacts. It reduces wear and damage caused by solid particles and abrasives in the fluid, maintaining measurement performance over an extended period of use. Heat resistance: The lining exhibits stable performance even in high-temperature environments. It resists degradation when exposed to high-temperature fluids and environments, ensuring consistency and reliability in the measurements. NOx measuring equipment For accurate measurement, dehumidify the sample with a dryer unit before measuring. It is dehumidified by the Flemion tube of the dryer unit, but it is necessary to purge dry gas around the Flemion tube. Cover the Flemion tube with a PFA tube, purging dry gas in between. Also, PFA tubes are used to connect the dryer unit and piping. Since NOx is highly adsorbable, PTFE, which does not easily adsorb, is used as a sampling tube. Used to connect flow sensor and PTFE tube. Differential scanning calorimeter Tubes to flow the liquid nitrogen below -196 degrees C. Flexible pipes made of metals other than resin cannot be used because of possible cracking due to cold embrittlement. In addition, because metals have high thermal conductivity, there is a greater risk of low-temperature burns during unintended contact and frost due to their high thermal conductivity. PEEKLess flexible. Tubes with an inner diameter of 16 mm are commercially unavailable. Inductively Coupled Plasma Mass Spectrometer (ICP-MS) To suck the liquid sample To flow the sample for the nebulize Chemical resistance against xylene, Kerosene, MIBK, DMF Total Organic Carbon analyzer(TOC) Oxides of nitrogen analyzer Tube to flow the ozone gas. ozone gas 30 / 111 Tubes and contacts must be airtight Micro flow rate liquid flow meter Flow path Figure 27 Fluororesin fitting Characteristics of PFA,PTFE Inert to many chemicals Resistance to aging Less additives Soft Easy to process Benefits of using PFA,PTFE Semiconductor manufacturing process is required high level chemical controls, due to chemical contamination makes negative influences on quality of products. PTFE and PFA which are inert to various chemicals and also include low additives, are suitable materials for flow paths in semiconductor manufacturing process. Impact of prohibition using PFA,PTFE It will be impossible to keep miniaturization technology used in current semiconductor manufacturing process. To avoid this problem would require a great deal of effort and technical innovation. 31 / 111 Endoscope Nozzles for water and air Light Figure 28 Treatment tool Hole for suction or treatment tools to exit A medical device that is inserted into the body from the oral cavity to observe and treat the inside of the lumen. A flow path of an air and water supply for passing water, air, or the like through a tip, a flow path of a forceps for inserting a treatment tool, and a flow path of a suction for sucking a body fluid or the like need to follow a complicated lumen shape. Among flexible materials, chemical resistance, low friction, heat resistance, and non-adhesion are required, and PTFE and PFA are used. Flexibility is a property necessary for insertion into complex lumens. Chemical resistance are necessary characteristics for disinfection and cleaning to prevent infection after use.It is a necessary characteristic for resistance to body fluids such as stomach acid. Low friction is a characteristic necessary for inserting a treatment tool for collecting tissue and performing surgery in the lumen, from the operation part to the tip. Heat resistance is a necessary characteristic to perform autoclave sterilization at 136 . Non-adhesiveness is a characteristic necessary for mucosa and the like not to stick in the flow path when inserting into a living body or sucking. PE can be mentioned as an alternative material, but it cannot be substituted because it is inferior in chemical resistance and heat resistance, so the quality of sterilization, disinfection, and cleaning is reduced, and the risk of infection increases. In addition to these properties, biocompatibility is required. Biocompatibility means that the risk of toxicity such as allergic reactions, chronic toxicity, and genotoxicity is small. Due to the chemical properties of fluorine compounds, the effect on living organisms is small, the purity of the material is high and the possibility of containing impurities is low, and the durability against chemical treatment is excellent and the possibility of unexpected deterioration is low. When alternative materials other than PFAS, only bench test evaluation cannot adequately evaluate safety, and based on ISO 10993-1, biologically safe such as cytotoxicity, sensitization, irritant or intradermal reaction, systemic toxicity, subchronic toxicity, genotoxicity, implantation, 32 / 111 hemocompatibility, etc. are evaluated again. * Hereafter, the above idea is used for application examples for biometric contact points. Figure 29 In addition, The exteriors that contain these flow paths and other components inside and are inserted into the body also require chemical resistance, low friction, heat resistance, and nonadhesion in a flexible material, and PVDF (polyvinylidene fluoride) is used. The reasons for the need for each characteristic are the same as above. Insulating tubes for surgical treatment tools In surgical procedures, high-frequency currents are applied to cauterize tissues and prevent bleeding. In order to cauterize only the intended portion, especially in the treatment tool called bipolar, a two-pole electrode is provided in the treatment tool. Therefore, pipes and rod-shaped members (ultrasonic drive members) serve as electrical paths, but heat shrinkable tubes by FEP are indispensable for insulating pipes and rod-shaped members and preventing short circuits in the electrical path between the two poles. In addition, in order to stabilize ultrasonic vibration, a function to attenuate unnecessary vibration is also essential. Figure 30 33 / 111 This is due to the chemical resistance, heat resistance, electrical insulation, and low frction required for surgical treatment tools. In addition to these properties, biocompatibility is required. See "Biocompatibility" in the endoscope section of "Plumbing" for details. Bipolar surgical RF instruments PFA CAS: 30525-89-4 Figure 31 Arc resistance to RF- plasma; Cleanability of surfaces; safe dielectric strength at small layer thickness; Non- Slip- Stick effect for movement; low friction for moving parts (after cleaning cycles- grease would be removed); heat resistance for steam cleaning and disinfection; high chemical resistance for cleaning and disinfection (Peroxide, etc.) PI is not flexible, has high slip- stick behavior PEEK will burn down under RF- plasma (arc) PET chemical resistance is to low, slip- stick behavior, non sufficient heat resistance There is no hazard and exposure risk. All materials in contact are controlled via ISO 10993. This product is single used All Cleaning disinfection tests have to be requalified, since low surface energy of PFA is unmatched it can be estimated that cleaning procedures have to be harsher in the future Endoscopic treatment tool Figure 32 34 / 111 A medical device for performing endoscopic procedures. In order to insert into the channel of the endoscope inserted into the body, it is necessary to follow the complex shape, and among flexible materials, PTFE and PFA are used because of their acid resistance, low friction, heat resistance, and non-adhesiveness requirements. Flexibility is a property necessary for insertion into complex lumens. Acid resistance is a necessary characteristic for resistance to body fluids such as stomach acid. Low friction is a characteristic necessary for insertion into the endoscope channel to the distal end. Heat resistance is a necessary property in devices that use high-frequency energy to prevent damage to the device or/and endscopes during treatment. Non-adhesiveness is a characteristic necessary for mucosa and the like not to stick in the flow path when inserted into a living body or sucked. PE can be mentioned as an alternative material, but since it is inferior at least in low friction, the treatment property is reduced due to the deterioration of insertability, so it cannot be substituted. In addition to these properties, biocompatibility is required. See "Biocompatibility" in the endoscope section of "Plumbing" for details. 1. Description : Fluoropolymers for use in medical devices Endoscope Applications 2. PFAS substance(s) used: name and CAS number (If known): PFAS substances including but not limited, Poly(1,1,2,2-tetrafluoroethylene), CAS # 9002-84-0 Perfluoro-alkoxy polymer, CAS # 26655-00-5 Copolymer of hexafluoropropylene and tetrafluoroethylene CAS # 25067-11-2 3. It is well known that C-F bonding energy is much higher energy than C-C bonding energy, the unique crystal structure of fluoropolymers, lower surface energy, hydrophobic as well. Due to its unique microstructure structure, and repellency from water, fluoropolymers have been used in medical device , such as endoscope with many benefits, including but not limited, 1. excellent biocompatibility, biostability, and patient safety history. 2.resistant to chemical, enzyme, and microbiological attacks while eliminating biodegradation issues. 3. low friction allows moving parts to slide with ease, generating less heat, and undergoing less wear and tear. 4. low surface energy or hydrophobic makes it non-adhesion material combined with its moisture barrier and chemical resistance, makes it a valuable polymer for medical device industry especially for patient safety with reusable endoscope application which involves cleaning and disinfecting the devices so that they can be reused. 35 / 111 4. These unique chemical-physical characteristics of fluoropolymers make medical devices safer to use for patients. However, the unique properties of fluoropolymers make them difficult to replicate with other non-fluoropolymers. For instance, To the best practices in polymer industry, the alternative materials for fluloropolymers are proposed as follows: Chlorotrifluoroethylene (E-CTFE), Ethylene Tetrafluoroethylene (ETFE), and so on and so furth. However, the proposed alternative materials are still under the umbrella of 2021 OECD definition of PFAS "Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it)" Silicone rubber could be proposed as an alternative substances for certain applications but not suitable for endoscope application because of its higher on coefficient of friction, especially to tackle a surgical procedure with difficulty anatomy conditions. Fuel Cell Performance Testing Equipment Fuel cells generate electricity and heat through a chemical reaction between hydrogen and oxygen. Fuel cell performance testing equipment evaluates the performance and durability of fuel cells. Fuel cells contribute to carbon neutrality by improving energy efficiency and reducing CO2 emissions. The following characteristics are required for the piping of the fuel cell performance testing equipment. - The piping serves as a flow path for alkaline substances used as materials for hydrogen and acidic substances produced as a result of the reaction. (Chemical resistance) - Since the polymer membrane used in the fuel cells requires wet condition, water vapor is added to the hydrogen. The flow path is heated to approximately 150C to prevent condensation of water vapor in the piping. (Heat resistance) - Hydrogen in the exhaust gas after the reaction may be reused, which requires an additional supply of hydrogen, resulting in large pressure changes inside the piping. Therefore, the piping needs to be strong. (Durability). In case of condensation in the piping, the concentration of water vapor added to hydrogen cannot be maintained at the required level and normal operation will be disturbed. In addition, a transparent pipe with chemical resistance may be used as a liquid level gauge to check the liquid level in the tank where the alkali solution is stored. For these reasons, the fuel cell performance testing equipment needs to be made of transparent, chemical (acid, alkali) resistant, heat resistant, and durable materials. Currently, 36 / 111 PTFE and PFA are the only such materials available, and they are difficult to replace. Piping Flange Packing Tank Liquid level gauge Figure 33 Valves Valves are general for equipment with a movable mechanism that can open and close flow paths in order to go through, stop, and control the flow of fluids. They are used in a wide variety of products, from relatively small devices with flow paths and valves to large-scale manufacturing processes and chemical plants. There are many types of valves. Some valves, which are often incorporated in specialist equipment, are discussed. They are not exhaustive. The functions and alternatives which valves require: The chemical resistance against acids, alkalis, organic solvents oils, and ozone, which flows through valves, is essentially required. Valves, which opens and close frequently required the property of low friction, repellency from water and oils, non-adhesion. Any failure of valves can cause serious accidents. therefore, the durability of fluoropolymer resin is required for valves PTFE and other fluoropolymer resins are frequently used. Fluoropolymer resins, such as, PTFE are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of valves. - Solenoid valve A solenoid valve is electromehanically operated. One of the operations is to open and close a valve using the principle that when an electric current is applied to an electromagnet (solenoid), an iron piece called a plunger is attracted and released when the electric current is cut off. Diaphragms divide into a valve compartment that opens and closes flow paths and 37 / 111 a functioning compartment that drives. Fluoropolymer resins, such as, PTFE, FKM, FFKM, and FEPM, are frequently used for flow paths, diaphragms, and sealing materials in solenoid valves. Solenoid valves have wide variety of types, such as, liner action, pilot operated, the combination of liner action and pilot operated. - Ball valves A ball valve opens and closes a flow path by rotating a hollow ball. In automatic valves, an electric motor is used to rotate the ball. A large cross-sectional area of the flow path can be obtained, and the resistance of the path can be kept low. Fluoropolymer resins, such as, PTFE, are frequently used Stem Ball Figure 34 Sheet - Check valve A check valve is installed on gas or liquid piping where the fluid back pressure closes the valve plug to prevent reverse flow. A check valve is called as non-return valve, reflux valve, retention valve, foot valve, or one-way valve There are disc check valves that blocks backflow by closing the O-ring valve with a disc and duckbill check valves that uses a valve plug shaped like a duck's beak. Fluorinated materials such as PTFE, FKM, FFKM and FEPM are used for the valve plug and the sealing materials of the housing. Figure 35 38 / 111 - Relief valves/safety valves A relief valve is a valve that automatically releases pressure when excessive pressure occurs in the pipes. A spring keeps the valve plug such as O-rings or diaphragms closed, and it opens (released) when a pressure exceeding the spring force occurs. Fluorinated materials such as PTFE, FKM, FFKM and FEPM are used for the valve plug and the sealing materials of the housing. Primary side Spring Pressure adjustment bolt Diaphragm Flow direction (atmospheric release) Figure 36 39 / 111 Examples of the products which incorporates valves Mass Flow Controller Elemental analysis is a method of complete combustion of organic compound samples, and high-purity oxygen gas and argon gas are introduced. (see below) Figure 37 The switching valve of the mass flow controller is a diaphragm type, and PTFE is used to provide flexibility to withstand repeated operation and durability against oxygen gases. PTFE is difficult to find replacement. Because it is highly non-adhesion and the substance does not stick to it like other fluoropolymers, and it has overwhelmingly low friction and excellent durability compared to other resins. Control valve of mass Flow Controller Mass flow controllers are used for flow control of various industrial gases. PTFE is used as the material of the valve body of the flow control valve of mass flow controller. See part (10) in the figure38 below (the right is a partial enlarged view). Performance requirements for materials. Heat resistant to withstand operation from -10C to +60C. Chemical resistance to withstand components contained in combustible gases. Resistant to ozone gas. 40 / 111 Cross-sectional view of the product Cross-sectional view of the valve Figure 38 Enlarged vie Mass flow controller for semiconductor manufacturing Mass flow controller for semiconductor manufacturing PFA coating is applied to the valve that functions to accurately supply the amount of etching gas in the etching equipment for semiconductor manufacturing. When the valve is closed, it must be tightly closed and impermeable to gas. Low friction is necessary because it must not wear out even with the impact of continuous opening and closing of the valve. The friction ecoefficiency of silicone is low, and silicone cannot be used for this application. Fluoride ion measuring equipment This equipment is mainly used to measure the concentration of fluoride ions in factory 41 / 111 wastewater. Fluoride ions are detected by an ion electrode, and the concentration can be monitored continuously by sending the sample to the flow cell holding the ion electrode with a liquid sending pump. The sample water is an aqueous solution such as factory wastewater. Various ionic components and insoluble solids are included depending on the type of production. Used as a switching valve for the solution feed channel The valve is used as a switching valve for the solution feeding flow path, and the body and diaphragm valve are PTFE solenoid valves. NOx measuring equipment NOx meter utilizes chemiluminescence generated in the process that NO and ozone react to produce NO2. Since the emission intensity is proportionally related to NO concentration, NO concentration is obtained by measuring the emission intensity. Since NO2 does not emit light, it is converted into NO by a converter, and NOx(NO+NO2) is measured, and then NO2 concentration is obtained from the difference between NOx density and NO density. So the NOx meter requires switching between the NO measurement line and the NOx measurement line. Also, during calibration, it is necessary to switch between the sample line and the calibration line. Since NOx has high adsorptivity, PTFE is required for NOx passing part, and therefore, a solenoid valve is used for switching. The NOx meter requires switching between the NO measurement line and the NO2 measurement line. Also, during calibration, it is necessary to switch between the sample line and the calibration line. A solenoid valve is used for switching. Control valves Control valves are used in a variety of different markets that controls fluid flows in plumbing installed in air conditioning system of building, and Industrial plants, for example petrochemical and power plant. 42 / 111 Control Valve for industrial plant rotary motion Plug up and down motion Valve Seat Seat Ring Control Valve for HVAC ball Figure 39 Examples of control valve products PTFE seat ring is a component of control valves that has a function of stopping the flow by contacting with the plug when it is fully closed. In general, the friction coefficient of PTFE (0.1 or less) is approximately 1/5 that of metal (approximately 0.5), and the torque required to rotate the plug is approximately 1/5 in proportion to the friction coefficient. Add that, corrosive and high temperature fluid flows through control valves. So, excellent chemical and heat resistance are required to control valves. PTFE fills all of characteristics aforementioned. Furthermore, it has proven track record of long-term use in various fields. Material for scraper rings in industrial control valves Stem Scraper Ring Valve Seat Bonnet Gasket Upper Cage Plug Lower Cage Seat Gasket Figure 40 43 / 111 The PTFE scraper ring scrapes off the fluid adhering to the cage of the control valve and prevents sticking of the plug and cage. Industrial control valves are used to control corrosive fluids such as chemicals, and are required to have performance that can withstand the control of corrosive fluids. On the other hand, in identifying corrosive fluids, there are many fluids that are difficult to determine physical properties such as intermediates of chemical substances, and materials that have a wide range of chemical resistance are required. In order to control corrosive fluids with industrial control valves, scraper rings made of PTFE are required in the flow passages where corrosive fluids come into contact. Other polymer materials, such as rubber and resin, might be able to substitute for PTFE as the material of scraper rings. However, it is considered that the alternative materials are not suitable, because they do not have enough resistance to various chemicals of chemical plants. Lining and throttling mechanism materials for industrial control valves. Aperture mechanism Figure 41 valve linings Industrial control valves are installed in pipes of various industrial plants, that are used to control flow of fluids. Industrial control valves are used to control corrosive fluids such as chemicals. Industrial control valves are required to be able to withstand the control of corrosive fluids at high temperatures (approximately 140C). In order to control corrosive fluids with industrial control valves, main body linings and throttle mechanisms made of PFA, ETFE and PTFE are required in the flow passages where corrosive fluids come into contact. Depending on the fluid used, PFA and ETFE are used in the body lining, and PTFE is used in the throttle mechanism. It is possible that other polymer materials such as rubber and resin can be used as alternative materials for body lining and throttle mechanism using PFA, ETFE, and PTFE. 44 / 111 However, alternative materials have poor resistance to a wide variety of chemicals in industrial chemical plants and cannot withstand corrosive fluids. If it is assumed that metal materials such as chromium and nickel alloys will be substituted, it is necessary to periodically stop the equipment and check the corrosion status of the control valves connected to the pipes. When corrosion occurs, fluid control becomes impossible, so it is necessary to replace the industrial control valve itself. endoscope reprocessor The endoscope reprocessors use a variety of chemical solutions such as acids, alkalis, and alcohols to clean and disinfect the endoscopes after use. Various valves such as solenoid valves, ball valves, check valves, and relief valves are used to switch the solutions and control the flow. If the performance of the valve is degraded or broken, the cleaning and disinfection of the endoscope may be inadequate, leading to crossinfection. Therefore, fluoropolymers such as PTFE, FKM, FFKM, and FEPM, which have high chemical resistance to various chemical solutions, are used for the valve discs, diaphragms, and sealing materials between housings in each valve. Other substances such as EPDM and silicone are not sufficiently resistant to these solutions, especially the peracetic acid used for endoscopes disinfection, because these substances deteriorate in a short period of time. Therefore, it is impossible to substitute other substances. Pumps Discharge Process Suction Process Valve Diaphragm Valve Figure 42 Explanation on Pumps 16 A pump is a device that transfers, pumps, and stirs liquids and gases under the action of pressure. It is divided into two types according to the difference in structure: non-positive displacement pumps and positive displacement pumps. Non-positive displacement pumps are pumps that impart energy to liquids by rotating impellers, and include centrifugal pumps, propeller pumps, and viscous pumps. A positive displacement pump is a pump that pressurizes and energizes a 16 https://www.monotaro.com/note/cocomite/525/ 45 / 111 liquid that is within a certain volume, and there are plunger pumps, diaphragm pumps, gear pumps, etc. In pumps, fluorine rubber such as FKM, FFKM, and FEPM is used for the sealing members and diaphragms of the housing. PTFE is used for the impeller bearings. PFAS functions which pumps require and alternatives Pumps used to transfer fluids such as acids, alkalis, organic solvents, oils, and ozone require high chemical resistance for each member in contact with the fluid. Especially in the case of diaphragms, durability that can withstand repeated bending are also required. Fluorine materials such as FKM, FFKM, and FEPM are used as materials to satisfy these requirements, and it is difficult to replace them with other materials. In the case of bearings, low friction, self-lubrication, and wear resistance are also required. Fluorine materials such as PTFE are used as materials to satisfy these requirements, and it is difficult to replace them with other materials. Examples of the products which incorporate pumps endoscope reprocessor The endoscope reprocessors use a variety of chemical solutions such as acids, alkalis, and alcohols to clean and disinfect the endoscopes after use. And the endoscope reprocessors use internal pumps to deliver these solutions to the outer surfaces and channels of the endoscope.If the performance of the pump deteriorates or breaks down, the cleaning and disinfection of the endoscope may be insufficient, leading to crossinfection. Therefore, fluoropolymers such as PTFE, FKM, FFKM, and FEPM, which have high chemical resistance to various chemical solutions, are used for sealing materials, diaphragms, and bearings in these pumps. Other substances such as EPDM, silicone and POM don't have sufficient chemical resistance to these solutions, especially to the peracetic acid solution which used to disinfect endoscopes, because these substances deteriorate in a short period of time. Therefore, it is impossible to substitute other substances. Coating/Lining Part Description A surface treatment in which the surface or inner surface of a base material is covered with a fluoropolymer is called a coating or lining. A relatively thick covering is often referred to as a lining, while a thin covering is often referred to as a coating. There are various methods such as molding, bonding a sheet to the base material, bonding powder, or covering with a liquid. Fluoropolymers used include PTFE, PFA, PCTFE, FEP, and ETFE. Metal plating and surface treatment containing fluoropolymer resins are used to adhere to metals. 46 / 111 Coatings and linings are applied to parts in contact with fluids. The parts include the inner surface of the piping and parts in contact with the fluid. Coatings may be applied to areas where water repellency to water and oil, low friction, self lubrication, and non-adhesion are desired. Examples of coating / lining Pipe Connection flange Lining Figure 43 Piping inner surface Figure 44 Coating and lining section of parts (diaphragm) in contact with fluid PFAS functionality required by coating/lining and possible substitutions By covering the surface with a fluoropolymer, PFAS gains chemical resistance/cleanliness and mold-releasing properties that the base material does not have. Coatings and linings in contact with fluids can withstand corrosion and operate stably without maintenance for long periods of time (10 years). For example, fluorine coatings and linings on low-hardness rubber materials provide both high flexibility and chemical resistance. When the fluid is a powder, it is difficult for the fluid to adhere to the coating/lining area due to non-adhesion of fluoropolymers. Coatings for instruments and tools for analysis and measurement 47 / 111 Analysis and measuring instruments are required to have chemical resistance because they may analyse and measure any kinds of chemical substances, including strong acids, strong alkalis, organic solvents, and oils, as samples. For correct analysis and measurement, no specimens or reference materials should remain in instruments or pipettes, tubes, etc. If residues remain, subsequent analysis and measurement will not be accurate. In order to prevent residues from remaining, coating should be applied to the areas where the specimens and reference materials are likely to remain. The fluoropolymer resins have the functions, such as, repellency from water and oils, and non adhesion. These functions can prevent residues from remaining, which resulting in accurate analysis and measurement. Examples of Parts and Equipment Using Lining and Coating There are a great many devices that coat base materials that come in contact with fluids. Lining for fluid contact parts of electromagnetic flowmeters and pressure transmitters Equipment around piping such as electromagnetic flowmeters and pressure transmitters cannot maintain their performance without fluoropolymer resin linings and coatings in order to withstand various fluids such as acids and alkalis. Linings using ETFE or PFA can operate stably for 10 years without maintenance. Accidents may occur if the equipment continues to operate with the fluid flowing through the piping without noticing that it has been corroded by the fluid. In order to maintain the work environment and safety management, it is necessary to use fluoropolymers that can be safely used for a long period of time without replacement for devices that pass corrosive fluids. Surface coating of the rubber roller (see photo below) that feeds the film in the thermal developing section of the laser imager A laser imager is a device that outputs various image data (general radiography, CT, MRI, etc.) taken by an X-ray machine onto DRY film, and doctors use these medical images to diagnose patients. The film with the image data output is fed by rollers. Image data is output by thermal processing (temperature 126C), so the rollers must be heat resistant. In addition, the material generated during thermal processing adheres to the rollers, causing image defects, feeding failures, and other problems, so releasability is necessary. Therefore, fluoropolymer coated rollers with heat resistance and releasability are required. Defects in the image may result in misdiagnosis or oversight. 48 / 111 Film ejection port Cooling feed unit Thermal process unit Supply tray1 Supply tray2 Supply tray3 Deodorant filter Exposure unit Scanning unit Position control unit Feed unit Feed unit Figure 45 Coating in the chemiluminescence cell of the nitrogen detector Elemental analysis is a method of complete combustion of organic compound samples, introducing high-purity oxygen gas and argon gas. In order to observe luminescence from chemicals which were introduced into the cell of the detector, anti-reflection and anticorrosion properties are necessary. Fluoropolymer resin materials are required as coating materials in cells with low refractive index and chemical resistance. In the nitrogen detector, the nitrogen compound in the sample is combusted and oxidized and reacted with ozone gas in the cell. Therefore, ozone resistance is required in the cell. 49 / 111 Figure 46 CLD Nitrogen Diagram On the other hand, in the sulfur detector, when the sulfur compound in the sample is combusted and oxidized, most of it becomes SO2 . When the generated SO2 is irradiated with ultraviolet light (190-230 nm) of a xenon lamp in the cell, fluorescence is emitted. Therefore, the inside of the cell is required durability against ultraviolet rays. Fluoropolymer materials meet each required specification at a high level. They are practically non-fungible. Please see the diagram of Mass flowmeter of UVFL diagram. Imaging Plate (IP) for Non-Destructive Testing and Medical Image Diagnosis IP consists of a 350m-thick polyethylene terephthalate (PET) material with excellent flatness and flexibility, coated with a special phosphor that produces photoluminescence. When an Xray is taken, the radiation passing through the object to be inspected is temporarily stored in this "phosphor layer" in the form of electronic energy distributed over the entire surface in proportion to the dose. The surface (white side) of the IP has a transparent "front protective layer" that prevents dirt and scratches from the "phosphor layer", and the back side has a "back protection layer" that covers the layer (black) that has a light blocking. Fluoropolymer is used for "front protective layer". X-ray information recorded in IP is read by Computed Radiography (CR) and CR generates Xray image. After reading with CR, the X-ray information recorded in IP can be erased by irradiating white light and can be used repeatedly. As IP is conveyed repeatedly within the CR, there is a risk that the surface will become dirty or scratched. 50 / 111 Dirt and scratches on the surface of the IP will cause defects in X-ray images, making accurate inspections and diagnoses impossible. Therefore, the surface of IP is required to be antifouling and low-friction. Fluoropolymer is the only material that satisfies the following property (antifouling, low-friction) and manufacturing suitability for coating. surface back side Figure 47 front protective layer Phosphor layer undercoat layer PET base back protective layer 51 / 111 Figure 48 Figure 49 52 / 111 Figure 50 Environment-resistant photoelectric switch with built-in amplifier. The Housing coated with black fluorocarbon resin. Fittings for fixing built-in parts Figure 51 External View/ Detection of workpiece seating in machine tool Improved corrosion resistance of housing The housing of Environment-resistant photoelectric switch is made of zinc die-cast. Zinc die-casting has advantages such as high fluidity, easy dimensional accuracy, low molding temperature, and long service life of metal mold, but it has low chemical resistance. 53 / 111 Therefore, it cannot be used in machine tools and automobile parts machining lines, which are users of this switch, unless corrosion resistance is improved by painting and plating. Water-soluble coolant (basic) is often used in machine tools and automobile parts machining lines, and zinc die-cast housing is highly likely to be corroded unless surface treatment such as painting is performed (Figure 51). Switch Figure 52 Confirmation of Existence of Tool in Machine Tool Prevention of crevice corrosion and dissimilar metal contact corrosion The H2B housing is assembled with a metal stopper (SUS plate (zinc plated)) (Figure 51) and attached to an accessory SUS bracket or the mounting surface of the user side (metal, resin, etc., materials cannot be specified) (Figure 52). Therefore, it is necessary that the metal surface of the housing is not exposed in order to prevent electrolytic corrosion due to gap corrosion and contact between different metals. The former model number of this switch had adopted acrylic coating, but it was changed to fluorine coating due to low resistance to water-soluble coolant. The surface of the housing must be free from exposed metal. Therefore, coating by coating is necessary instead of plating. For the same reason, coating is necessary even if the housing is changed to a highly chemical resistant metal material such as SUS. There are concerns about the following impacts due to the unavailability of this technology Affects machining with machine tools that use water-soluble coolant and parts machining and production on automotive parts production lines 54 / 111  There is no alternative technology. When a switch without fluorine coating is used, corrosion of the switch causes contamination of corrosion products (foreign matter) into parts, generation of rust in processed parts, and increase of stoppage period of machine tools and production lines due to increase of sensor replacement frequency. For the above-mentioned reasons, the prohibition of coatings with fluorine-based paints should be exempted indefinitely from this restriction because of the economic burden due to the increased frequency of replacement and the serious degradation to the finished product. In terms of disposal, restrictions should not be applied as coatings by fluorinated paints generally lead to a reduction in waste. Spatter-guarded proximity switch Part of the housing of the spatter-guarded proximity switch used in a welding environment. CapFluoropolymer resin PFA sensing surface HousingCoated with fluoropolymer resin. Housing Cap Figure 53 Spatter-guarded proximity switch The following features can be obtained by using Fluoropolymer resin. CapIt can withstand the heat of welding spatter. It is difficult for spatter to stick. HousingIt is difficult for spatter to stick. 55 / 111 Endoscope(Coating) Figure 54 A guidewire used to secure the insertion route of the treatment tool when performing procedures for periods that are difficult to approach, such as the pancreatic bile duct. By coating fluoropolymer resin on the surface of a substrate such as metal, it acquires acid resistance, low friction, and non-adhesiveness that cannot be possessed by the base material alone. Biocompatibility and chemical resistance are also important characteristics for use as medical devices. Chemical resistance is a necessary characteristic for resistance to body fluids such as stomach acid. Low friction is a characteristic necessary for smoothly guiding the treatment tool and inserting the treatment tool into the target site. Non-adhesion is a characteristic necessary for the mucous membrane and the like to not stick when inserted into a living body. There is no coating material other than fluoropolymer resin that satisfies all of these properties. Aliphatic urethane has poor low friction, and the necessary quality cannot be ensured, such as deterioration of treatment performance due to deterioration of insertability. In addition, there is a method of using a gas such as EOG or hydrogen peroxide as a sterilization method, and since it is exposed to sterile gas, chemical resistance is a necessary characteristic. There is no material that has chemical resistance equivalent to fluoropolymer resin and has low friction. In addition to these properties, biocompatibility is required. See "Biocompatibility" in the endoscope section of "Plumbing" for details. Endoscope A medical device that is inserted into the body from the oral cavity to observe and treat the inside of the lumen. 56 / 111 Coating fluoropolymer Figure 55 By coating fluoropolymer (PTFE etc.) on the surface of base materials such as resin or rubber , chemical resistance, acid resistance, alkali resistance, heat resistance, low friction, and nonadhesiveness that cannot be possessed by the base material alone are acquired. In addition, flexibility is a necessary characteristic for insertion into complex lumens. Chemical resistance , acid and alkali resistance are necessary characteristics for disinfection and cleaning to prevent infection after use. Acid resistance is a characteristic that is also necessary for resistance to body fluids such as stomach acid. Low friction is a characteristic necessary for smooth insertion into the lumen to reduce pain. Heat resistance is a necessary characteristic to perform autoclave sterilization at 136 C. Non-adhesiveness is a characteristic necessary for the mucous membrane and the like to not stick when inserted into a living body. There is no coating material other than fluoropolymer that satisfies all of these properties. Aliphatic urethane has poor heat resistance, chemical resistance, and low friction, and the quality of sterilization, disinfection, and cleaning decreases, increases the risk of infection, and increases patient pain. For example, in hydrogen peroxide sterilization, which is currently becoming mainstream, it has been confirmed that the coating surface easily deteriorates, and coating peeling occurs in less than half the cases compared to fluorine-based coatings. As a sterilization method for endoscopes, there is a method of using gases such as EOG and hydrogen peroxide, and since sterile gas also penetrates the inside of the product, chemical resistance is a necessary characteristic even for internal parts. Sterilization methods are limited by the methods that can be used depending on the region, and it is not enough to be able to correspond to any one as a product, but it is necessary to be resistant to all sterilization methods. Furthermore, in metal mechanical parts such as O-rings provided on sliding parts and curved operation wires built-in, in addition to chemical resistance, low friction is required to reduce friction between members, so similarly, coatings containing fluoropolymer such as PTFE and PTFE-Ni plating are required. For example, when the coating of the operation wire 57 / 111 is replaced with a non-PFAS member such as boron nitride, carbon, and silicone, which are general coating agents, the frictional resistance between the members increases, and the bending operation of the endoscope requires 2~5 times greater traction force than the fluorinated coating. In addition, there is molybdenum disulfide as another non-PFAS material, but although the lubrication performance is relatively excellent, it is difficult to replace it due to the risk of toxic substances generated in hydrogen peroxide sterilization. As described above, PFAS materials are indispensable because there is no material having chemical resistance equivalent to fluoropolymer and low friction. In addition to these properties, biocompatibility is required. See "Biocompatibility" in the endoscope section of "Plumbing" for details. 1. Description : Fluoropolymers for use in medical devices Surgical Guidewire Applications Figure 56 2. PFAS substance(s) used: name and CAS number (If known): PFAS substances, including but not limited, Poly(1,1,2,2-tetrafluoroethylene), CAS # 9002-84-0 Perfluoro-alkoxy polymer, CAS # 26655-00-5 Copolymer of hexafluoropropylene and tetrafluoroethylene CAS # 25067-11-2 3. It is well known that C-F bonding energy is much higher energy than C-C bonding energy, the unique crystal structure of fluoropolymers. lower surface energy, hydrophobic as well. Due to the unique microstructure structure, and hydrophobic characteristics, fluoropolymers have been used in medical device, such as endoscope with many benefits, including but not limited, i. excellent biocompatibility, biostability, and patient safety history. ii.resistant to chemical, enzyme, and microbiological attacks while eliminating biodegradation issues. iii. low coefficient of friction allows moving parts to slide with ease, loading device effectively as well. iv. low surface energy or hydrophobic makes it nonstick material combined with its moisture barrier and chemical resistance, makes it a valuable polymer for medical device especially for physician to tackle a surgical procedure with difficulty anatomy conditions. 58 / 111 4. These unique chemical-physical characteristics of fluoropolymers make medical devices safer to use for patients. However, the unique properties of fluoropolymers make them difficult to replicate with other non-fluoropolymers. For instance, to the best practices in polymer industry, the alternative materials for fluloropolymers are proposed as follows: Chlorotrifluoroethylene (E-CTFE), Ethylene Tetrafluoroethylene (ETFE), and so on and so furth. However, the proposed alternative materials are still under the umbrella of 2021 OECD definition of PFAS "Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it)" Coating of surgical instruments The tissue gripping part consists of two parts. (Electrode member in contact with tissue and jaw holding electrode member) gripping part Figure 57 jaw holding member electrode Figure 58 59 / 111 Electrode member Figure 59 Since the tissue gripping surface of the electrode part is a part where burnt tissue tends to stick very easily because of the high-frequency current being passed through it, it is especially essential for gripping surface to be non-sticking. This is because if they don't have the nonstickness, the bleeding that has been stopped will be re-bleeding due to the operation when releasing the adhesion, which is very dangerous. In addition to chemical resistance, heat resistance, electrical insulation, and low friction required for surgical treatment tools, Ni-PTFE plating is essential because mechanical properties that can withstand heat, pressure, and mechanical damage when assembling pads are required at a particularly high level and have electrical conductivity. In order to prevent unnecessary energy from acting on the living body, the outer surface of the jaw does not conduct electricity (has insulating properties) and becomes hot due to the heat generated during treatment, so it is very important to be non-adhesion like the electrode part. PFA coating is indispensable for biocompatibility, chemical resistance, heat resistance, electrical insulation, and low friction required for surgical treatment tools. In addition to these properties, biocompatibility is required. See "Biocompatibility" in the endoscope section of "Plumbing" for details. Flame arrestor (sintered metal) surface Figure 60 60 / 111 Sintered metal flame arrestor is used to prevent the internal gas sensor element from becoming an ignition source. Surrounding gas reaches the sensor element through fine gaps in the sintered metal, but when water is adsorbed on the sintered metal, the flow path of the gas narrows. Therefore, in order to prevent water adsorption and corrosion on sintered metal, a fluorine coating is applied for the purpose of adding repellency from water and chemical resistance. - Inside the metal nipple Figure 61 Fluorine coating is applied to the inside of the metal nipple which is part of the gas flow path for the purpose of adding non adhesion in order to prevent the gas concentration from decreasing due to the adsorption of highly adsorptive gases. Repellency from water The flame arrester (sintered metal) is given water repellency by applying a fluorine coating to prevent clogging due to water adsorption and corrosion. Non-adhesion Fluorine coating is applied to parts of metal pipes that cannot be used due to insufficient strength of fluoropolymer resin pipes, such as when it is necessary to cut threads to fix them. Chemical resistance Fluorine coating is applied to the parts used in the gas flow path to provide chemical resistance. Fluorine coating can be used in acids, alkalis, organic solvents, ozone, and oils. Fuel Cell Performance Testing Equipment:Coating of tank Fuel cells generate electricity and heat through a chemical reaction between hydrogen and oxygen. Fuel cell performance testing equipment evaluates the performance and durability of fuel cells. Fuel cells contribute to carbon neutrality by improving energy efficiency and reducing CO2 emissions. The Fuel cell performance testing equipment supplies hydrogen obtained from an alkaline substance to the fuel cell. It stores the alkaline liquid to obtain hydrogen in a stainless steel tank, which cannot be used for a long period of time because the stainless steel is corroded by 61 / 111 the alkali. Therefore, the tank surface is protected by coating with PTFE. Moreover, hydrogen gas used for fuel cell is necessary to add water vapor. The tanks for to control the dew point of the added water vapor can reach temperatures above 150C. Thus the coating material must be heat resistant. So far, PTFE is the only material which has both chemical and heat resistance. Piping Flange Packing Coating Tank Solution Figure 62 Temperature sensor Contact type temperature sensors can measure temperature by contacting the object to be measured and reaching to the same temperature. The sensor measures the temperature using the element itself or an element inserted into a protective tube for strength. Temperature sensors can measure a wide range of objects, including acids, alkalis, and organic solvents, and can also measure a wide range of temperatures, including applications that measure chemicals at 100C or higher. Therefore, sensor elements, wires themselves, and protective tubes are coated with FEP or PFA to eliminate the adverse effects of chemicals and high temperatures and realize accurate measurement. There is no material other than fluoropolymers that combines chemical resistance and heat resistance to realize such applications, and it is difficult to replace them. 62 / 111 Protective tube Coating Element Coating Wire Element(internal) Figure 63 Fluorine-coated temperature sensor Membrane filters Membrane filters are to remove and separate specific substances or objects from fluids. A wide variety of materials are used. If fluorine compounds are necessary, PTFE, FEP, ETPE and PFA are frequently used. Membrane Dissolved oxygen electrode Electrolyte Electrochemical gas sensor Figure 64 Measurement method of pH meter and diagram of membrane filter Measurement method of pH meter and diagram of membrane filter 1. Gas components in the sample are go into the electrode through the membrane. 2. The pH of the internal solution changes according to the amount of the gas taken in, and the change of pH is read by a glass pH electrode. 63 / 111 3. The pH change of the internal solution is converted to gas concentration in the sample. The following properties are required for the membrane used in this application. There is currently no other material that possesses these properties at a level that can be used in products. Gas permeability Membrane must have sufficient gas permeability even under conditions of no pressure. Chemical resistance Membrane must have sufficient chemical resistance that will not deteriorate after immersion in various samples. Repellency from water Repellency from water is required in order not to permeable water. PVC, glass and PEEK are too high much gas barrier property to separate gases. PE is weak for acids. Glass is melt down by hydrogen fluoride and some gases. Fluorine compounds such as PFAS are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of membrane filters. PTFE filter used in the ozone decomposition catalyst unit of NOx measuring equipment A NOx meter needs to generate ozone to measure NOx by the chemiluminescence method. For accurate measurements, ozone is generated in excess of NOx in the sample. An ozone decomposition catalyst is used to decompose ozone remaining after NOx measurement, and a PTFE filter is used to remove the catalyst powder. PTFE filter is a filter with little adsorption and decomposition. Use is recommended in the Environmental Air Constant Monitoring Practices Promotion Manual. It also has better ozoneresistance than PVC and PE and is less priced than PEEK. PTFE porous membrane Electrochemical gas sensor Figure 65 PTFE porous membrane Electrochemical gas sensor 64 / 111 1. Electrochemical gas sensor is constituted by a working electrode formed on a PTFE porous membrane, a reference electrode, a counter electrode, electrolyte and a housing which is holding other components. 2. Every electrode is connected to a potentiostat circuit and the working electrode is implied fixed potential to that of the reference electrode. 3. The PTFE porous membrane is in contact with atmosphere which may contain intended gas to be detected. 4. The gas to be detected goes through by diffusion in the membrane and reaches the interface of the working electrode and the electrolyte. 5. The gas is electrochemically oxidized or reduced. 6. The oxidized or reduced reaction involves transfer of electrons between chemical species and the working electrode, hence current flows in the circuit. 7. The current is measured to determine the concentration of the gas to be detected. The following properties are required for the membrane used in this application. There is currently no other material that possesses these properties at a level that can be used in products. Gas permeability The membrane must have gas permeability at atmospheric pressure. Water resistance The membrane must have sufficient water resistance not to leak electrolyte. Corrosion resistance The membrane must have corrosion resistance. Examples of corrosive gases are NOx, SOx, halogen and halogen halide. Heat resistance The membrane must have sufficient heat resistance over 150 degree Celsius to coat electrocatalyst. Non-adsorptive The membrane must have sufficient non-adsoptive. If the gas to be detected is adsoabed on the membrane, the gas can't go through the membrane, or it takes time to go through the membrane. 65 / 111 Galvanic oxygen sensor Figure 66 Galvanic oxygen sensor 1. Oxygen gas in the sample reaches through the membrane into the sensor. 2. The oxygen gas taken in is reductively decomposed at the cathode. A current flows according to the oxygen amount taken in. 3. The current is read as a voltage through a resistor such as a thermistor. The following properties are required for the diaphragm used in this application. Gas permeability The gas to be measured is taken into the electrode. This measurement is not possible without sufficient oxygen permeability even under conditions of no pressure. Among fluorine compounds, FEP has superior oxygen permeability compared to other polymer membranes. Chemical Resistance FEP is used in environments where it is in constant contact with various gases (acids, alkalis, organic solvents, etc.). The membrane filter does not deteriorate in these environments, does not elute components of the membrane filter when in contact with any sample, and must be resistant to chemicals. Water repellency and water resistance The membrane filter must be hydrophobic and water resistant to prevent water from permeating into the electrode. The material must not change after 10 years of exposure test as a material. 66 / 111 Other examples Endoscope(Electrical Contact Unit) PFAS components are used inside Figure 67 In the electrical contact unit of the endoscope, ePTFE sheet is used for parts that require ventilation while waterproofing. When connecting watertight with a plug and receptacle, an air escape path is secured inside. Otherwise, high pressure will occur between the plug and the receptacle, causing poor work or damage. Since the air escape path at this time is connected to the inside of the product, waterproof performance is required as a protection of the electric parts. Therefore, by utilizing the porous structure of ePTFE, it is waterproof and moderately breathable. There is no substitute material that is resistant to deterioration by chemicals and gases and is both waterproof and breathable. Endoscope Reprocessor Figure 68 Air filter Filter for air delivery. Filters out airborne bacteria and microscopic debris. 67 / 111 After cleaning and disinfection the endoscope, a PTFE membrane filter is used as an air filter for compressed air to remove water from the endoscope channels. The filter must have filter sterilization properties (pore size of 0.2 m) to prevent recontamination of the endoscope after cleaning and disinfection. It must have biocompatibility so that there is no risk of toxicity if debris remains the endoscope and is used in the patient. Furthermore, for sterilization of the air filter itself, it is necessary to have heat resistance and chemical resistance that can withstand autoclaves and EtO. And it is necessary to have repellency from water so that moisture in the air that condenses during compression does not adhere to the endoscope. Fluoropolymers such as PTFE are used as materials that satisfy these characteristics. and there is no substitute materials Figure 69 A PTFE filter is used as a ventilation filter for disinfectant bottles such as peracetic acid solutions. Since the peracetic acid disinfectant generates peracetic acid gas over time, the gas need to be released by the PTFE filter that is moisture-permeable and waterproof with a porous structure to prevent bursting the bottle . In addition, this filter is required to have high chemical resistance to prevent deterioration by the internal disinfectant. PTFE are used as materials that satisfy these characteristics, and there is no substitute materials. Optical coating A water-repellent coating layer which contains Perfluoroalkyl or perfluoropolyether compounds is formed with a thickness of less than tens of nm on the outermost surface of coating layers of the ophthalmic lens surfaces. The water repellent coating provides superior properties such as water repellency, oil repellency, lubricity, smoothness and chemical resistance to the ophthalmic lens. These properties improve prevention of water discoloration on anti-reflection coatings, scratch resistance, ease of wiping off stains (fingerprints, sebum, etc.) on the lens surface and maintainability. As the results, these high performances enable to extend substantially the product life of lenses. 68 / 111 And the water-repellent coating layer is coated on anti-reflection coating layers to eliminate the ghost and flare phenomena in lens optical systems. The one of valuable features is having both properties of low refractive index (n<=1.40) and high transparency of the coating layer which composed of perfluoroalkyl or perfluoropolyether compounds. *1 Ghosting/flare: Reflected light generated on the lens surface is repeatedly reflected in complex ways, resulting in the appearance of light images that are not actually there. The higher the reflectivity of the lens surface, the more likely it is to appear. *2 Anti-reflection coating: A film with a function to reduce reflected light. In ophthalmic lenses, reflection is reduced by alternately layering materials with different refractive indices to utilize light interference. *3 Low refractive index: Since the lower the refractive index of the film of the top surface layer of an antireflection coating, the greater the effect of reducing reflections from the lens surface, a film material with a lower refractive index is required. The refractive index of general glass is 1.52, and the refractive index of base materials for eyeglass lenses is 1.50~1.90 (including plastic and glass). Figure 70 Functions of PFAS that required for lens coating and their alternatives. 69 / 111 Ophthalmic lenses Ophthalmic lenses are daily exposed to sunlight, rain, sweat, and washed with detergents. So, high level repellency from water and oil are required for the coating of ophthalmic lenses. PFASbased coatings are widely used because of their excellent weatherability, low friction, and repellency from water and oil. The water-repellent coatings have been developed since the 1980s, but it is still very difficult to achieve the target performances with non-fluorine compounds. Even after more than 30 years effort, no coating without PFAS, which can pass abrasion resistance, chemical resistance, and weather resistance tests assuming everyday use, has been developed yet. As the proposal alternatives, silicone-based water repellents are representative material, though they can achieve fluorine-based equivalents in terms of contact angle to water, they have not been able to achieve fluorine-based equivalents in terms of contact angle to oil, chemical resistance, and low refractive index. Test results Performance comparison of fluorine-based perfluorinated polyether water-repellent coating and silicone-based polydimethylsiloxane water-repellent coating Table 15 Contact angle Scratch resistance Chemical resistance To water H2O To oil (Oleic acid C18H34O2 Steel wool load 500g 50 round-trip After 6hr dipping in alkaliNaOH aq. pH:11 After 6hr dipping in acidHNO3 aq. pH:1 Perfluorinated polyether 108 80 Good Good Good Polydimethylsiloxane 104 52 Bad Bad Bad 70 / 111 Details Pictures of appearance after scratch test perfluorinated polyether polydimethylsiloxane Contact angle change in chemical resistance test Table 16 Contact angle change in chemical resistance test Alkali Water Oleic acid Perfluorinated Before 108 80 polyether After 105 70 Before 105 52 Polydimethylsiloxane After 42 40 Water 108 104 105 48 Acid Oleic acid 80 70 52 31 Water repellent effect by coating Without coating With Coating Figure 71 Difference among lens with coating and without coating 17 17 Cannon optron https://optron.canon/ja/evaporation/pickup01.html accessed on 31 May 2023. 71 / 111 Period required for replacement: About 1.5 to 2 years, if a non-fluorine material with PFASequivalent performance is produced. Volume of PFAS to be placed on the EU market : car camera 0.32g/year Amount of PFAS entering in the EU as water-repellent coating materials on ophthalmic lenses The amount of PFAS entering the EU as water-repellent coatings on ophthalmic lenses is estimated to be 300 kg/year*1. The amount of PFAS entering the EU through water coating*2 is much smaller (1 ppm to 2 ppm) than the total amount of PFAS entering the EU through all applications (140,000 to 310,000 ton/year). <Explanation for estimating the amount of PFAS entering the EU as water-repellent coating materials of ophthalmic lenses> The amount of PFAS entered in the EU as ophthalmic lenses was calculated from the product of the annual sales volume of eyeglass lenses in the EU and the amount of PFAS coated as hydrophobic coating film per lens. 1. Hypothesis Assume that all vision corrective spectacle lenses sold in the EU have a hydrophobic coating on both sides. 2. Estimate 1) Annual sales volume of eyeglass lenses in the EU 200,000,000 pcs/year (200 million pcs/year) *1,*2 2) Amount of PFAS per lens (both sides) ** 1.5 x 10-3 g/pcs 3) Amount of PFAS entering the EU through spectacle lenses 1) 2) = 300 kg/year 4) Total amount of PFAS entering the EU 140,000 to 310,000 tons/year *3 5) PFAS content ratio by spectacle lens 9.7E-072.1E-06 (1ppm2ppm) **The net PFAS amount a is the solid content coated as the water-repellent coatings on both sides of the lens, excluding the solvent. Assuming that the total amount a is deposited on the total number of lenses b that are put in. The amount of PFAS per lens is calculated as a/b. 72 / 111 Therefore, The PFASs amount entering in EU countries as water-repellent coating materials for ophthalmic lenses is much smaller than that entered in EU as other industrial application. 3. Reference *1 WORLD LENS AND FRAME DEMAND STUDY 2022, SWV https://www.ewintelligence.com/world-lens-and-frame-demand-study-2022/98489.article *2 Spectacle Lenses - Europe https://www.statista.com/outlook/cmo/eyewear/spectacle-lenses/europe *3 ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION, P.22/224, Socio-economic analysis, "For the EU, this resulted in an estimated amount of 140 000 to 310 000 t of PFASs introduced to the market in 2020," https://echa.europa.eu/documents/10162/f605d4b5-7c17-7414-8823-b49b9fd43aea Examples of devices with lenses PFAS is mainly used for outdoor sensors, lenses of surveillance cameras, etc., and protective panels on the surface of smartphones and other devices. Without the use of PFAS, it would not be possible to meet the required specification of water contact angle (100 or more). As a result, the visibility of the image will be poor, and the function of the sensor or surveillance camera will not be established. Examples Anti-fog and anti-smudge coating for endoscope tip lenses Figure 72 MaterialOrganofluorine compound It is an organic fluorine compound and has good hydrophilicity and water repellency, so it is highly effective in preventing dirt and water droplet adhesion. Inorganic MgF2 and SiO2 are 73 / 111 used as lens coatings, but they have insufficient hydrophilicity and repellency from water, and dirt and water droplets stick to the lens during diagnosis, hindering diagnosis. Anti-reflective coating material for endoscopes Material4,5-Difluoro-2,2-bis(trifluoromethyl)-1,3-dioxole,polymer with Tetrafluoroethylene CAS RNo37626-13-4 Since it is a fluorine resin and has good elasticity, it has high chemical resistance and heat resistance even when coated on the WLO resin lens part. Inorganic materials such as MgF2 and SiO2 are used as lens coatings, but their elasticity is insufficient, and in reflow resistance and reusable endoscope resistance tests, coating cracks occur on the WLO resin lens, resulting in defects. Optical fibers are embedded inside the endoscope to transmit illumination light and images of the inside of the body. As shown in the figure below, an optical fiber consists of a core and cladding made of multi-component glass, with a coating containing PFAS (fluorinated silane coupling agent) on the outside. Figure 73 A PFAS coating is applied to the fiber surface to ensure chemical resistance to withstand disinfection and sterilization of the endoscope, and sliding to reduce friction between members that occurs during pulling and bending operations. As a substitute, when non-PFAS materials such as boron nitride, carbon, and silicone, which are general lubricants, are used, the frictional resistance between the fibers and other materials increases when the endoscope is repeatedly bent, and more than half of the fibers break. In the worst case, there is a risk that all the fibers break and the illumination light will not reach the body cavity during the use of the endoscope, resulting in a loss of observation, which is extremely dangerous. Molybdenum disulfide is another non-PFAS lubricant, which has relatively good lubrication performance, but it is difficult to replace molybdenum disulfide because of the risk of generating toxic substances in hydrogen peroxide sterilization, which is now becoming mainstream. 74 / 111 Fiber unit for Measurement use Fluorine resin With FEP and PFA Figure 74 Structure This is a step index type multimode fiber (using the refractive index difference between core and clad). Fluorine resin is used for the clad. No alternative material has been proposed by the manufacturer at present. In this type of fiber, the basic optical characteristics of the fiber are determined by the refractive index difference between core material and clad material, and the material is selected by the manufacturer in consideration of the manufacturing method. Users use commercially available fiber. FEP is used for the clad and jacket, and PFA is used for the jacket and outer coating. Liquid level detection Detection method and part of use PFA PFA Purpose and materials used The tip detection part is made of PFA, and the tube material which may come into contact with liquid is also covered with PFA, a material which is easily fused with the tip. Principle using PFA characteristics Use refractive index difference between PFA and liquid In order to make the tip small and non-electric, a commercially available plastic optical fiber cable is used for guiding the detection light, and fluorine resin (specific material is not disclosed by the manufacturer) is also used as the clad material. It uses the difference in refractive index between liquid and liquid. Detection principle It utilizes the return light difference due to the refractive index difference (hereinafter referred to as n) between the material of the tip cone and the external contact material. Without liquid : In a state of lower refractive index than PFA (n 75 / 111 Leak detection PFA 1.35) (air n 1), most of the light emitted from the projection is reflected by the inner surface of the cone and returns to the light receiving portion to enter. Liquid : The liquid has a large refractive index equal to or higher than that of PFA (water n 1.33, ethyl alcohol n 1.36), and the amount of light that is substantially transmitted through the conical surface and returns to the light receiving portion decreases. The presence or absence of liquid is determined by this light amount difference. The detection head and cable, which may come into contact with liquid, PFA coverare covered with PFA. Use refractive index difference between PFA and liquid Chemical resistance Transparent examPFpAle PFA The detection head and cable, which may come into contact with liquid, are covered with PFA. Detection principle is the same as "liquid level detection" Sealing performance is ensured by fusing the tip of the PFA detection head and the tube. PFA Figure 75 Due to the housing made of PFA resin, this fiber unit has higher stability against organic solvents than other products. The following characteristics can be obtained by using PFA resin for the fiber unit. 76 / 111 - This fiber unit functions stably for the detection of organic solvents. - There is no alternative to this function This leakage sensor is used for the following applications. - Liquid leakage detection in semiconductor wafer cleaning and developing processes - Detection of tank leakage There are concerns about the following effects due to the unavailability of this technology : - Cleaning and development of a semiconductor wafer using an organic solvent cannot be carried out safely. For the above reasons, the prohibition of PFA resin in leakage sensors affects safety and should be exempted from this restriction indefinitely. Optical fiber for data communication (End products: LC, LCMS, protein sequencer protein sequencer, ICPMS, ICP, GC) VDF plastic is used for the clad of optical fiber.VDF plastic has a lower refractive index than that of PMMA which is used for the core, and VDF is clear plastic. https://www.pofeska.com/index.html Its use is for data communication between devices. LED with a wavelength of 660 nm is used for the light emitting device for transmission. https://www.broadcom.com/products/fiber-optic-modules-components/industrial/industrialcontrol-general-purpose/650nm/hfbr-1532etz Figure 76 Even if there is an alternative material that meets some of the properties, we believe that it is almost impossible to cover all the properties, including optical, mechanical and environmental properties. 77 / 111 Medical Fiber Optics 1.Fluoropolymers used in medical optical fibers for medical devices Applications PFAS POF Figure 77 2. PFAS substance(s) used: name and CAS number (If known): PFAS substances, including but not limited, Poly(1,1,2,2-tetrafluoroethylene), CAS # 9002-84-0 Perfluoro-alkoxy polymer, CAS # 26655-00-5 Copolymer of hexafluoropropylene and tetrafluoroethylene CAS # 25067-11-2 Poly(ethene-co-tetrafluoroethene CAS # 25038-71-5 3. It is well known that C-F bonding energy is much higher energy than C-C bonding energy, the unique crystal structure of fluoropolymers, lower surface energy, hydrophobic as well. Due to the unique microstructure structure, fluoropolymers have been used in medical device, such as endoscope with many benefits, including but not limited, i. excellent biocompatibility, biostability, and patient safety history. ii.resistant to chemical, enzyme, and microbiological attacks while eliminating biodegradation issues. iii. low co-efficient of friction allows moving parts to slide with ease, loading device effectively as well. iv. low refractive index (RI), 1.3 1.4, makes it valuable low refractive index polymer for optical fiber application used in medical device, in which cladding materials have to be lower refractive index than core materials in order to meet total internal reflection specification through Snell's law. 4. These unique chemical-physical characteristics of fluoropolymers make medical devices safer to use for patients. However, the unique properties of fluoropolymers make them difficult to replicate with other non-fluoropolymers. For instance, to the best practices in polymer industry, the alternative materials of fluloropolymers for Polymer Optical Fiber (POF) applications are proposed as follows: Chlorotrifluoroethylene (E-CTFE), Ethylene Tetrafluoroethylene (ETFE), and so on and so furth. However, the proposed alternative 78 / 111 materials are still under the umbrella of 2021 OECD definition of PFAS "Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it)" Silicone rubber, RI about 1.4 at 819 nm, could be proposed as an alternative substances for limited POF applications but POF need another jacket layer with lower RI materials such as fluoropolymers beyond its limitation mechanical behavior for medical optical fiber applications. Heat medium Refrigerators, compressors, centrifuges Refrigerators are used for the units require temperature control, and pretreatment for measurement and analysis. Fluorinated gases are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of refrigerators, such as, thermodynamic efficiency, surface tension, electrical insulation, inactivity, heat conductivity, and a wide range of operating temperature. HFCs as F-gas will be restricted by the EU F-gas regulation and international treaties. HFCs will be replaced by organic fluorine compounds that their GWP are smaller than carbon dioxide. In that case, the substituted organic fluorine compounds (GWP>1) will be further substituted. A succession of substitutions in a short period shortens the lifetime of specialist equipment, which is originally long-life. Refrigerators, compressors, centrifuges are used as units of specialist equipment, the derogation as spare parts should be considered. Specialist equipment cannot be repaired, it will be discarded and its lifetime will be shortened. Refrigerants must not leak from the unit, the units that uses refrigerants such as refrigerators, compressors, and centrifuges requires the sealing materials mentioned in this document. 5(f), (g), and (h) of proposal wordings are written in Annex A of the restriction report. Specialist equipment with a long Lifetime cannot be sufficient grace periods. The grace periods should be examined. Lubricating oil Lubricating oil is used to control friction and wear of metal contacting parts when machines are combined to rotate, reciprocate, or otherwise operate. In addition to suppressing friction and wear, this oil also suppresses corrosion and frictional heat, and its sealing and cleaning properties allow the machine to operate smoothly. Lubricating oil formulated with PFAS have the following characteristics Low friction: Reduces the adverse effects of friction on the lifetime and performance of components. Heat resistance: Resistance to chemical changes even when used in high-temperature environments. Resistance to ignition. 79 / 111 Weatherability: Excellent oxidation stability and resistance to adverse effects of oxygen. Not decomposed by moisture. Chemical resistance: Resistant to chemicals such as acids and alkalis. Chemical resistance/cleanliness: Almost no deterioration of rubber and plastic materials. There is no other lubricant besides fluorinated synthetic lubricants that can satisfy all of the above characteristics. Lubricant oils in the products. Mass Flow Controller / Mass Flow Meter Mass flow controllers and mass flow meters are used for flow control and flow measurement of various industrial gases. Lubricating oil is applied to joint screws and O-rings to prevent screw galling and improve the assembly of O-rings. Figure 78 screw Ordinary grease and oil cannot be used because they may become a source of ignition when flammable oxygen gas is used, so their safety is significantly impaired. Computed Radiography (CR) for Non-Destructive Testing PTFE is used for the coating of parts inside the solenoid of the lock mechanism of the IP loading part of CR. The durable life of CR is about 6 years. In order to achieve this, it must be durable enough to withstand 540,000 times of IP loading from the assumed frequency of use of CR. PTFE's low friction property is essential, and replacing it with nickel plating reduces the durability to about 1/6, reducing the durable life of the equipment from 6 years to 1 year. 80 / 111 IP Figure 79 Pressure Transmitter 1)Measuring Principal A pressure transmitter consists of a barrier diaphragm that contacts the process pressure, a center diaphragm that protects the sensor, and a sensor that detects the pressure. If there is a difference in pressure on each barrier diaphragm, the fill fluid that carries the pressure creates a pressure difference on either side of the sensor, which distorts the sensor and changes its resistance. Measure the pressure by converting the resistance change of the sensor. 81 / 111 Standard type High Pressure Sensor Low Pressure Center Diaphragm Remote type Barrier Diaphragm Yellow and orange area mean fill fluid Pressure Figure 80 In addition to the following items, the properties required for the fill fluid include fluidity even at low temperatures, low viscosity, and nonflammability. The only fill fluid that offers all of these is the fluorinated fill fluid, and there is no alternative. The diaphragms that come into contact with process fluids may be damaged due to corrosion or abrasion during use. When broken, the fill fluid comes into direct contact with the process fluid, but otherwise does not leak into the environment. This product is a WEEE target model and is in a controlled state for disposal. 82 / 111 Since the fill fluid is in direct contact with the sensor, high electrical insulation performance is required. PCTFE can use up to 120 degree Celsius, Perfluoropolytrimethyleneoxide can use up to 260 degree Celsius. Stable against strong corrosive acids and alkalis. Does not react with chlorine and oxygen even under high temperature and pressure. Surface tension:2628N/m Silicon oil: Most likely fill fluid but reacts with chlorine and oxygen at high temperatures and pressures, and in the worst cases explodes. Coding for sliding rubber parts of industrial controllers A PTFE-coated lubricant is applied to the outer circumference of the packing to make it easier to separate the front bezel from the case. Since the housing is made of resin, there is a risk of solvent cracking, and grease cannot be used. Figure 81 Overall product Figure 82 Packing installation explanatory diagram Medical uses Medical device implants Description : Fluoropolymers for use in medical devices Implants Applications ENT -Myringotomy Ventilation Tube Application 83 / 111 Figure 83 PFAS substance(s) used: name and CAS number (If known): PFAS including but not limited, Poly(1,1,2,2-tetrafluoroethylene), CAS # 9002-84-0 Perfluoro-alkoxy polymer, CAS # 26655-00-5 Copolymer of hexafluoropropylene and tetrafluoroethylene CAS # 25067-11-2 Poly(ethene-co-tetrafluoroethene CAS # 25038-71-5 It is well known that C-F bonding energy is much higher energy than C-C bonding energy, the unique crystal structure of fluoropolymers, low surface energy, hydrophobic as well. Due to its unique microstructure structure, and hydrophobic characteristics, fluoropolymers have been used in medical device , such as implants with many benefits, including but not limited, i. excellent biocompatibility, biostability, and patient safety history. ii.resistant to chemical, enzyme, and microbiological attacks while eliminating biodegradation issues makes it a 84 / 111 valuable polymer for some implants applications. These unique chemical-physical characteristics of fluoropolymers make medical devices safer to use for patients. However, the unique properties of fluoropolymers make them difficult to replicate with other non-fluoropolymers. For example, to the best practices in polymer industry, the alternative materials for fluloropolymers are proposed as follows: Chlorotrifluoroethylene (E-CTFE), Ethylene Tetrafluoroethylene (ETFE), and so on and so furth. However, the proposed alternative materials are still under the umbrella of 2021 OECD definition of PFAS "Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it)" Silicone rubber could be proposed as an alternative substances for implants applications but with certain limitation beyond its mechanical properties. Medical devices inserted into the living body Medical devices inserted into the body need to be covered with rubber or resin material to protect the outer surface of the drive unit, and FKM or fluororesin (PVDF, etc.) is used in areas where chemical resistance, biocompatibility, heat resistance, and non-adhesiveness are required. Chemical resistance is necessary for disinfection and cleaning after use to prevent infection. Biocompatibility is necessary for medical devices to be inserted into the body. Heat resistance is necessary for autoclave sterilization at 136 degree Celsius. Non-adhesiveness is necessary to prevent adhesion of mucous membranes and other substances that adhere to the device when it is inserted into the body. Figure 84 Thermoplastic polyurethane (TPU) is an alternative material, but it cannot be substituted because it has poor chemical resistance and heat resistance, so the quality of sterilization, disinfection, and cleaning decreases, and the risk of infection increases. In the inside of the driving part, grease mixed with PTFE and graphite fluoride are used to ensure low friction while having chemical resistance and heat resistance. As a sterilization method, there is a method using gases such as EOG and hydrogen peroxide, and since sterile gas also penetrates the inside of the product, chemical resistance is a necessary characteristic 85 / 111 even for internal parts. Sterilization methods are limited by the methods that can be used depending on the region, and it is not enough to be able to correspond to any one as a product, but it is necessary to be resistant to all sterilization methods. In grease which does not contain PTFE as a thickener, it cannot be sterilized because of insufficient chemical resistance. In addition, molybdenum disulfide can be mentioned as an alternative to graphite fluoride, but this is also inferior in chemical resistance, so it cannot be sterilized and cannot be substituted. PTFE sheet Figure 85 Since the fluorine material has excellent low friction and non-adhesion while having chemical resistance, PTFE sheets are used between the sliding parts of the drive unit. Since there is no material other than fluorine having similar properties, change to alternative materials is not possible. Solvent for cleaning and draining endoscope lens components Figure 86 HFE, the fluorinated composite material has good drying properties, no heat resistance, and low surface tension, so it has high particle removal ability. Non-flammable drying technologies include rotational drying and hot air drying using water as a solvent, but dry stains are likely to occur on the lens surface and are insufficient, and if they are incorporated into the product 86 / 111 as they are, endoscopic image defects will occur and diagnosis will be hindered. Description : Fluoropolymers for use in medical devices Endoscope Applications PFAS substance(s) used: name and CAS number (If known): PFAS including but not limited, fluorocarbon elastomers (FKM) Fluorocarbon elastomers, such as Fluorocarbon elastomers(FKM) , are the unique elastomers developed, which have been used in medical device such as endoscope with many benefits, including but not limited: i. fluorocarbon elastomers have a wide working temperature range from -26C to 205C, which is critical for high temperature sterilization applications, such as steam sterilization, dry heat sterilization, which are current standard sterilization practices in hospital. ii. fluorocarbon elastomers have a wide range of chemical resistance, which is critical for low temperature sterilization applications, such as hydrogen peroxide gas plasma sterilization, high level disinfection, and other liquid chemicals for cleaning. iii. fluorocarbon elastomers have excellent aging characteristics, which is very important for shelf time of medical device products. Resectoscopes including electrodes to resect tissue (tumor or BPH) PTFE CAS: 9002-84-0 Figure 87 Figure 87 Arc resistance to RF- plasma; Cleanability of surfaces; safe dielectric strength at small layer thickness; Non- Slip- Stick effect for movement; low friction for mounting in and on pipes and rods; low friction for moving parts (after cleaning cycles- grease would be removed); high temperature resistance for steam cleaning and disinfection; high chemical resistance for cleaning and disinfection (Peroxide, etc.) There is no hazard and exposure risk. All materials in contact are controlled via ISO 10993. 87 / 111 This product is single used -PI is not flexible, has high slip- stick behavior -PEEK will burn down under RF- plasma (arc) -PET chemical resistance is to low, slip- stick behavior, non sufficient thermal stability -All Cleaning disinfection tests have to be requalified, since low surface energy of PTFE is unmatched it can be estimated that cleaning procedures have to be harsher in the future. Pad It is essential for ultrasonic surgical device to have the pad which conacts with ultrasonic probes that are vibrating at high speeds. Figure 88 During surgery, the tissue is sandwiched between the pad and the ultrasound probe, and the tissue is incised without bleeding due to the frictional heat and friction action caused by ultrasonic friction. During the incision of the tissue and after the incision is completed, the ultrasonic probe and the pad come into contact with the ultrasonic vibrating at high speed. In order to reduce the frictional heat generated at this time, it is necessary that the pad has low friction. In addition, even if the friction is low, the ultrasonic probe vibrates at high speed, so high wear resistance is required. In addition, a large amount of heat is generated due to friction. Since this is a surgical treatment tool, it is essential to have chemical resistance (acid and alkali resistance), heat resistance, and electrical insulation. The PTFE is the only material that can withstand that's friction and heat, so PTFE is indispensable. (If it is another member, it will melt easily and become unusable immediately.) In addition to these properties, biocompatibility is required. See "Biocompatibility" in the endoscope section of "Plumbing" for details. 88 / 111 Probe holder Probes Suppress exists to prevent pipe and ultrasonic probe that is vibrating at high speed from being destroyed and forming unintended electrical paths by coming into contact with each other. Figure 89 By performing surgery from a small port, it is necessary to reduce the burden on the patient by reducing the wound created on the patient's outer surface during surgery, and it is necessary to make it thin as a surgical treatment tool. As a result of thinning, the rigidity is weakened, so if the equipment is accidentally twisted with the tissue in between, the probe may deflect and come into contact with the pipe. In order to prevent this, it is necessary to be able to withstand wear and heat generation due to contact with a probe that vibrates at high speed, and it is essential to be able to withstand heat resistance, slipperiness, and wear resistance. In addition, the viewpoints of biocompatibility, chemical resistance (acid and alkali resistance), mechanical physical properties, flame retardancy, and electrical insulation required for energy surgical treatment tools are also essential. In particular, moldability is important to maintain the fineness of equipment, and PFA is indispensable. In addition to these properties, biocompatibility is required. See "Biocompatibility" in the endoscope section of "Plumbing" for details. Monopolar and bipolar surgical RF instruments with Halar coating ECTFE CAS: 25101-45-5 89 / 111 Figure 90 In below picture PFAS is used for coating for insulation Figure 91 Arc resistance to RF- plasma; Cleanability of surfaces; safe dielectric strength at small layer thickness; Non- Slip- Stick effect for movement; low friction for mounting in and on pipes and rods; low friction for moving parts (after cleaning cycles- grease would be removed); high 90 / 111 temperature resistance for steam cleaning and disinfection; high chemical resistance for cleaning and disinfection (Peroxide, etc.) PI is not flexible, has high slip- stick behavior PEEK will burn down under RF- plasma (arc) PET chemical resistance is to low, slip- stick behavior, non sufficient thermal stability All Cleaning disinfection tests have to be requalified, since low surface energy of ECTFE is unmatched it can be estimated that cleaning procedures have to be harsher in the future Others Solvent for oil content analyzer Solvent for oil content analyzer is chlorotrifluoroethylene (CAS RN 9002-83-9). (hereinafter "specific chlorotrifluoroethylene solvent") Solvent extraction-nondispersive infrared absorption method is used for oil content measurement. The light from the light source enters the cell filled with the oil-extracted solvent. After that, an interference filter introduces only the absorption wavelength range (3.4 to 3.5 m) attributed to stretching vibration between carbon-hydrogen bonds (C-H) into a detector (pyrosensor). As the oil content in the oil extracting solvent increases, the light transmitted through the cell is decreased, and the current value generated by the pyroelectric effect decreases. The oil content can be calculated using this current value. Infrared absorption method for oil content analysis is standardized in ASTM standard D7066-4. Sample cell Pyroelectric sensor Light source Reference cell Light source window Chopper Interference filter Figure 92 Oil content analyzer bench structure Extraction of oil from solid samples is performed by immersion as shown in the figure below. 91 / 111 Figure 93 Method for extracting oil from solid samples Functions of PFAS required by solvent for oil content analyzer and substitutability The oil content is quantified by Beer-Lambert law using absorption attributed to carbonhydrogen stretching vibration at 3.4 to 3.5 m (2941 to 2857 cm-1). Therefore, the extraction solvent must not have absorption in this wavelength range. Chlorotrifluoroethylene has no carbon-hydrogen bond (C-H) in its molecular structure and has no absorption at 3.4 to 3.5 m, so it is suitable as a solvent for oil content measurement using the solvent extractionnondispersive infrared absorption method. Figure 94 IR spectrum of oil Existing solvents used for cleaning parts and general reagents that do not have carbonhydrogen bond (C-H) in their molecular structures were verified, but it could not be adopted because it did not meet the following performance requirements. Influence of infrared absorption From the principle of the analyzer, it is necessary to have no absorption higher than that of the specific chlorotrifluoroethylene solvent in the wavelength range of 3.4 to 3.5 m (2941 to 2857 cm-1). 92 / 111  Safety The specific chlorotrifluoroethylene solvent is not listed in the Montreal Protocol and the Kigali Amendment and are not classified in the EU CLP Regulation Hazard Classification. With a boiling point of 134C and a vapor pressure of 1.33 (kPa), it does not easily volatilize during use, so it can be used with normal ventilated environment. Similar safety and operability are required for alternative material. Analyzer performance cannot be achieved The measurement range of the oil content analyzer is 0-200 mg/L. The light source and the detector are designed and adjusted to achieve the specified performance in the range of 0200 mg/L when measured using the specific chlorotrifluoroethylene solvent. Therefore, as with the influence of infrared absorption, a low absorption rate equivalent to that of the specific chlorotrifluoroethylene solvent is required for measurement in the analyzer range of 0-200 mg/L Table17 comparison of solvents Composition Name Specific Chloro trifluoro ethylene Chlorotrifluoroethylene polymer 1-bromo propane + stabilizer aliphatic hydro carbon + ester (CAS RN) 9002-83-9 Boiling point degree 134 Celsius 106-94-5 stabilizer: unknown 48 unknown 174 Classification of EU CLP Regulation Not Classified Montreal Protocol and Kigali Amendment Absorption around 3.4- 3.5 m KB value 400 mg oil solubility Alternative? Not applicable Small 31 Possible - Not applicable Not applicable Large Large 13 - - Unsuitable Unsuitable Decane Decane 124-18-5 172 Not Classified Not applicable Large - Unsuitable Undecane Undecane 1120-21-4 196 Not Classified Not applicable Large - Unsuitable 1-bromo propane 1-bromopropane 106-94-5 71 Flam. Liq. 2 Skin Irrit. 2 Eye Irrit. 2 STOT SE 3 STOT SE 3 STOT RE 2 Repr. 1B Not applicable Large 121 Unsuitable Trichloroethylene Trichloroethylene 79-01-6 87 Skin Irrit. 2 Eye Irrit. 2 STOT SE 3 Muta. 2 Carc. 1B Aquatic Chronic 3 Not applicable Large 130 Possible Unsuitable tetrachloroethylene tetrachloroethylene 127-18-4 121 Carc. 2 Aquatic Chronic 2 Not applicable Middle 90 Possible Unsuitable 93 / 111 Solvent PFAS Release Risk Using: With a boiling point of 134C and a vapor pressure of 1.33 (kPa), it does not easily volatilize during use. And the specific chlorotrifluoroethylene solvent is not listed in the Montreal Protocol and the Kigali Amendment and are not classified in the EU CLP Regulation Hazard Classification, so safe to use. After use: Only the oil can be removed from used specific chlorotrifluoroethylene solvent with a dedicated equipment and can be reused Existence and Possibility of Alternatives: There is no alternative solvent that can ensure the same performance and safety as the current one. Period required for substitution when a substitute material is developed: 4-5 years Solvent: There is no alternative solvent that can ensure the same performance and safety as the current one. X-ray Film for Non-Destructive Testing Figure 95 X-ray film for non-destructive testing is widely used for the following inspections. Pipelines, Aircraft engines, Nuclear power plants, Bridges, Structures, Fine ceramic parts, Electronic parts, Castings, Welds The following properties of PFAS are essential for X-ray films, and PFAS (particularly fluorosurfactants) is the only material that can provide these properties with a single material, and at present there are no substitutes. Surfactant Strong hydrophobicity of the perfluoroalkyl group is required in the coating manufacturing process. 94 / 111 By using a perfluoroalkyl group as the hydrophobic group of the surfactant, the surface activity is strengthened, and the surface tension of the coating liquid is lowered, thereby improving the coating performance. Antistatic agent In order to achieve the performance required for X-ray films for NDT, the strong electronegativity of fluorine atoms is necessary. Due to the strong electronegativity of the fluorine atom, perfluoroalkyl groups tend to be negatively charged. The gelatin used in the film is naturally prone to positive charging, and PFAS is used as a material to lower it to the negative side in order to adjust this to an appropriate charging characteristic (charging series). Proper electrification makes the film less likely to be charged with static electricity during Xray photography, reducing the risk of blackening (image defects) due to discharge. <Example of application Pipeline inspection Aircraft and engine inspection Nuclear power plants Bridges Structures Fine ceramic parts Electronic components Castings Welded parts (Technical Explanation of Non-Substitutability) Controls the surface tension of the coating solution as a coating aid. Stabilizes dispersion of hydrophobic functional materials as an emulsion dispersing agent. As a conductive material, it adjusts the electrostatic charge of the coating film and suppresses statics. As a lubricant, it imparts slipperiness to the surface of the material. Adding anti-fouling property to the surface as a surface modifier PFAS (especially F element surfactant) is the only compound that can provide many of these functions in a single material, and there are no alternative candidates at this time. 95 / 111 Limit switch button, housing and rubber seal 1Internal switch button 2Painting the housing 3Used for each rubber seal of limit switch Figure 96 Although the exterior coating can be changed to other coatings, fluorine is the lowest and most suitable for internal sliding properties. Slidingplunger and housing Sliding: internal switch button and internal switch cover Addition of fluorine improves slidability. Table 18 18 Dynamic friction coefficient (ud) Heatresistant( degree Celsius) Fluoropolymer PTFE 0.09 260 Resin PE 0.13 70-110 POM 0.18 80-120 The retention of seals at high temperatures is superior to other rubbers. Switching to silicone rubber is difficult to adopt because of the risk of contact failure. In addition, it is often used for applications such as cutting fluid that damage silicon rubber, so it cannot be used. 18 https://www.y-skt.co.jp/magazine/coating/lowfriction/ 96 / 111 High-Speed Impact Testing Machines Rubber ring for cushion To absorb shock Figure 97 Strength, shock absorption capacity (speed 20 m/sec) It is used in a thermostatic bath. It must withstand temperatures between -40 and 150 degrees Celsius. Liquid leak sensor Liquid tank Liquid leak sensor The sensor housing is made of PFA resin. Figure 98 97 / 111 Schematic diagram of sensor structure The sensor housing cover, case and tube are made of PFA resin. Figure 99 Due to the housing made of PFA resin, this leakage sensor has higher stability against organic solvents than other products. The following characteristics can be obtained by using PFA resin for the leakage sensor. - This leakage sensor functions stably for the detection of organic solvents. This leakage sensor is used for the following applications. - Liquid leakage detection in semiconductor wafer cleaning and developing processes - Detection of tank leakage There are concerns about the following effects due to the unavailability of this technology : - Cleaning and development of a semiconductor wafer using an organic solvent cannot be carried out safely. Reserver for adding pressure Ultrasound Probe In ultrasonic probes, when the acoustic coupling medium expands as a result of temperature changes, the internal pressure of the medium chamber may increase excessively. It results in damage to the sealing part of the medium chamber and possible air bubble contamination. Resin is used as the material that makes up the media chamber because of its acoustic properties. Even if the media chamber is sufficiently sealed, during long-term use, the pressure inside the media chamber gradually decreases due to elongation caused by the creep phenomenon of the resin. As a result, the pressure inside the media chamber becomes lower than the external pressure, and air may permeate through the resin that constitutes the media chamber. If air bubbles are introduced into the media chamber, they become reflectors of ultrasound waves, which inhibits ultrasound transmission and reception. As a result, the ultrasound image is degraded. 98 / 111 In this type of ultrasonic probe, it is necessary to adjust the pressure in the media chamber to suppress the generation of bubbles, and fluorine rubber, which has low permeability to gases and liquids, is used to achieve this objective. Cross-sectional view of an ultrasonic probe coupling liquid Reserver for adding pressure Image of Reserver for adding pressure (A)adding pressure (B) unpressurized Figure 100 Period required for replacement: About 1 years, if a non-fluorine material with PFAS-equivalent performance is produced. Mold release coating for the injection molding of plastic lenses In the injection molding of plastic lenses and lens unit housings, we use a mold release coating on the surface of the mold to prevent the plastic from sticking to the mold during removal from the mold (mold release) after filling the mold with plastic. Thereby, it can improve moldability. The type of PFAS for the release coating is not disclosed due to confidential information. If this release film is not coated, the yield of the molding process will be less than 10%. The reasons why release coating is especially necessary for plastic lenses and lens unit housings are as follows. 1. Effect on lens optical performance If the next injection molding is performed with plastic adhering to the mold, the part of the molded product corresponding to the part of the mold to which the plastic has adhered will be transferred in the shape of the adhered plastic, creating a dent in the molded product. Especially in the case of lenses, if even a part of the lens is dented, optical performance is 99 / 111 greatly affected and the product becomes defective. 2. Decreased production efficiency When resin adheres to the mold, molding must be stopped and the adhered resin removed from the mold. If this frequency is high, production efficiency will decrease. Plastic lenses also tend to adhere, mainly because of the following reasons: 2-1. Since the required shape accuracy is very strict, the pressure to transfer to the mold must be high. As a result, the resin tends to stick to the mold during mold release more than other plastic parts. 2-2. Dirty mold surfaces due to continuous molding make it easy for resin to adhere to the surface. Standard white calibration plate (Colorimeters) Colorimeters, which measure and quantify color, are widely used for quality control of "color" of products and materials in various industries, such as automobiles, information appliance (IA), cosmetics, and apparel, to improve management efficiency and quality. A high-performance colorimeter measures the reflectance at each wavelength (360 to 740 nm for visible light) by spectroscopy of the light reflected from the object being measured at each wavelength. To obtain accurate measured color values, it is necessary to calibrate the measurements when starting up the colorimeter and in some cases once every few hours, and a white calibration plate is used for this purpose. A white calibration plate is a standard reflector with a pre-valued reflectance, which must have a reflectance of at least 95% (ideally 100%) at all measurement wavelengths. Crystalline PTFE is used as the standard reflective calibration plate. PFAS functions required by standard reflective calibration plates and the possibility of alternatives White calibration plates (standard reflectors) need lots of requirements as follows; high reflectance (95% or higher) in all visible light ranges as described above, as well as material stability, such as stability under various conditions of use, suppression of surface degradation (decrease in reflectance) due to light exposure and aging, and no change in reflectance due to cleaning using chemical products (e.g. silicone solvent). 100 / 111 Figure101 UV Reflectance Comparison 19 Most of the white reflective calibration plates used in current products are made of leaded ceramics. Lead is an exempted use (category 9, 13b) of the RoHS Directive, but this is expected to expire soon. After the expectation, we have searched for an alternative for a long time, and PTFE is the only material that satisfies the requirements. There are currently no alternatives to PTFE, except for leaded ceramics, which will be regulated by the RoHS Directive. Cutting parts (Example of finished products: diaphragm galvanic oxygen sensors, oxygen detectors) It is a part manufactured by cutting a block of resin. Because it is a small-lot production product, it is produced by cutting that does not require mold costs. Another reason for cutting is that there are places where sealing properties are required. Here, I will touch on the machined parts used in the casing of the galvanic oxygen sensor. There are various materials, but we will describe the case where PTFE and PFA, which have higher chemical resistance, are used. Figure 102 Example of Fluoroplastic Cutting Parts 19https://www.thorlabs.co.jp/newgrouppage9.cfm?objectgroup_id=13871#:~:text=%E3%83%9D%E3%83%AA%E3%83%86 %E3%83%88%E3%83%A9%E3%83%95%E3%83%AB%E3%82%AA%E3%83%AD%E3%82%A8%E3%83%81%E3%8 3%AC%E3%83%B3(PTFE,%E3%82%88%E3%82%8A%E3%82%82%E5%84%AA%E3%82%8C%E3%81%A6%E3%81 %84%E3%81%BE%E3%81%99%E3%80%82 last accessed on June 11 2023 101 / 111 Please see "Membrane filters" for galvanic oxygen sensors Fluoropolymer casing are required when parts require chemical resistance. There is a need to measure oxygen concentration even in places where acids, alkalis, and organic solvents are always present. In this application, it is necessary to have chemical resistance such that it does not deteriorate even when it comes into contact with various gases (acids, alkalis, organic solvents), does not elute components even when it comes in contact with any sample. Also, as a material, it is necessary to have weather resistance properties such as not changing in a 10-year exposure test and not softening or deforming in the surrounding environment of 40 to 70 C. If you try to perform the same function with other materials, for example, phenolic resins and polyamide resins can be mentioned as resins that are resistant to acetone as a general organic solvent, but phenolic resins are resistant to strong alkalis. Polyamide-based resins cannot be used as a substitute because they do not have durability against strong acids. Sapphire Capacitance Diaphragm Gauge Components corresponding to a heater operating temperature of MAX 250C For the picture of this products, please see the explanation in electric wires and insulation. Components compatible with gauge head operating temperature of MAX 250C LEMO connector Board connection cable Cable jacket and dielectric contain Perfluoroalkoxy alkane(PFA) Sensor, Temperature sensor for control Board connection cable Sheath, insulator, etc. contain Perfluoroalkoxy alkane(PFA) Figure 103 102 / 111 Humidity element for humidity sensor and dew point temperature sensor Sector "Electronics and semiconductors (Annex E.2.11.)" "Construction products (E.2.13.)" Sub uses :Monitoring and control instruments Heating, Ventilation and Air Conditioning(HVAC) Polymeric PFAS /Fluorinated polyimide Generic name for the final product: Humidity sensor, Dew point temperature sensor Common name for application parts: Humidity element Detailed application description: The humidity sensor chip used for a humidity sensor and a dew point temperature sensor measures humidity by capacitance change between electrodes sandwiching the moisture sensitive film. The thickness of the moisture sensitive film is several m. Schematic diagram of sensor chip structure Polymer moisture-sensitive membrane is made of fluorinated polyimide Figure 104 This humidity sensor is used for the following purposes Humidity sensor installed in an environment in which condensation appears on the sensor itself, such as inside the HVAC duct and the outside air intake section. The following features can be obtained by using fluoride polyimide for humidity sensor The humidity sensor works stably for a long period in an environment where the sensor is condensed (100% humidity). Nothing to replace this function. The humidity sensor has higher stability under high temperature, high humidity and condensation than other products due to the humidity sensitive membrane using fluorinated polyimide. The prohibition of this technology is concerned about the following effects. 103 / 111  It won't be able to properly measure and control humidity on HVAC system in an environment in which condensation appears on the sensor itself. Other polymer materials such as methyl methacrylate resin (PMMA), polyimide, polysulfone, etc. can be candidates as alternative technologies and materials. However alternative technology requires replacement of the sensor every time condensation occurs. For example, it is known that condensation appears on a humidity sensor which is inserted into an outside air intake duct several times a year depending on the weather. Humidity sensors without moisture sensitive membrane using fluorinated polyimide for this application will require replacement at least once a year. Moisture sensitive membranes using fluorinated polyimide can withstand at least 8 years of use. Performance requirements for materials (PFAS) Heat-resistant:180 degree Celsius as a humidity sensitive element Repellency from water:Electrical insulation in condensing environments Chemical resistance:Resistant to organic solvent atmosphere Alternative Considerations:No substitute material Required derogation period13.5 years or more Valve for air volume and room pressure control Materials for ensuring sliding, corrosion resistance, chemical resistance, and solvent resistance for air volume valves. Use sector: "Medical devices (Annex E.2.9.)", "Construction products (E.2.13.)" sub-uses: Control valve, Heating, Ventilation and Air Conditioning(HVAC) PFA26655-00-5 PTFE9002-84-0 PVDF24937-79-9 ETFE25038-71-5 Generic name for the final product: Valve for air volume and room pressure control Common name for application parts: Body, Pivot arm, S-link, Shaft, Spring, Cone, Brackets, Seal), Tap, e-crip), Bush, Slider, Sleeve, Cap, Bolt Detailed application description The two main applications of valves are below. (1) To be installed as a local exhaust ventilation system to prevent workers from being exposed to substances harmful to the human body, such as in chemical manufacturers and biotechnology research laboratories. For example, when a worker opens or closes the door of the local exhaust device (red dotted 104 / 111 frame in Figure ), the differential pressure across the valve suddenly changes, but by taking advantage of the good sliding property, the valve can be instantly changed to the appropriate valve opening position to maintain exhaust at a constant air volume. In addition, since valves must control fluids containing various chemicals and solvents, they must be resistant to corrosion, chemicals, and solvents. Flexible hood Arm hood Chemical storage bottle cabinet Ventilated sink Sink hood photo from the website of Dalton Corp, and AS ONE Corp. Figure 105 Example of air volume control in a chemical/ Other exhaust applications (2) The device is installed in hospital rooms and wards as a negative-positive pressure control device to secure hospital beds for patients with infectious diseases and to protect healthcare workers from infection risk. Even when the differential pressure across the valve suddenly changes due to the opening and closing of the hospital room entrance door, etc., the air supply and exhaust valves respond instantly by taking advantage of their good sliding characteristics and change to the appropriate opening position, thereby always maintaining the pressure difference between the room and outside. Figure 106 Image of negative and positive pressure control in a hospital room 105 / 111 The parts used in valves that include candidates for regulation are below. Seal,Tap Bush Figure 107 Valve image Slider Bolt E-crip Sleeve Ca Figure 108 Slider assembly (1) For valves that do not require corrosion resistance, chemical resistance, or solvent resistance, parts (Slider, Sleeve, Cap) containing PTFE should be used to ensure sliding properties. (2)Valves that require corrosion resistance, chemical resistance, and solvent resistance use the following parts to ensure the above three functions and sliding properties. Parts containing PTFE (Slider, Sleeve, Cap, Bush, Seal, Tap) Parts containing PFA (Shaft, Spring) Parts containing PVDF or ETFE (Body, Pivot arm, S-link, Cone, E-crip, Bolt) Technical Description of Essential Uses As mentioned above in "Detailed application description", valves must have the sliding property required to respond instantly to sudden disturbances, and the corrosion, chemical, and solvent resistance required to control fluids containing various chemicals and solvents. 106 / 111 Therefore, it is necessary to place parts containing PTFE, PFA, PVDF, and ETFE for mechanisms that need to ensure sliding properties and for channel parts that are in contact with the control fluid. (1) Ensure sliding properties Other polymeric materials may be used as an alternative to PTFE for ensuring sliding properties. However, since there is no material with lower sliding resistance than PTFE, the sliding resistance force will increase and the sliding performance required for valves cannot be ensured. (2) Ensure sliding properties, corrosion resistance, chemical resistance, and solvent resistance Other polymeric materials, such as rubber and resin, may be used as alternatives to PFA, PTFE, PVDF, and ETFE for the purpose of ensuring the above four functions. However, the alternative materials cannot ensure the sliding properties, corrosion resistance, chemical resistance, and solvent resistance required for valves due to the deterioration of sliding properties as described in (1) and the lack of resistance to various chemicals and solvents. The following effects are feared as a result of the unavailability of these technologies. The inability to use PFA, PTFE, PVDF, and ETFE for valves will make it impossible to carry out normal operations at chemical manufacturers, biotechnology research facilities, hospitals, and other facilities. This will have a profound impact on the production and supply of medicines, the progress of research in biotechnology, and isolated medical treatment, including coronas. For the above reasons, the prohibition of the use of parts containing PFA, PTFE, PVDF, and ETFE in valves should be exempted from this restriction in terms of ensuring safety for the human body. In terms of disposal, the restriction should not be applied to valves containing PFA, PTFE, PVDF, and ETFE, since these components can be used until the product reaches its original service life, leading to a reduction of waste in general. Performance requirements for materials (PFAS) Heat-resistantHeat-resistant max93 degree Celsius Chemical resistanceResistant to chemicals, solvents and corrosive fluids Sliding performance:Wear resistance due to sliding, sliding performance Non-adhesion:Non-adhesion of foreign matter 107 / 111 Mechanical parts for sliding or releasing applications used in "Specialist equipment" Fluoropolymers with excellent low friction, and self-lubrication and mon-adhesion. properties are often used in mechanisms that require sliding with plastic and metal parts or releasing from sticky materials.. The following common characteristics are related to the reason why fluoropolymers are particularly selected for "Specialist equipment". 1) Some final products handled by "Specialist equipment" require use in special environments. For example, in facility environments where foods, liquids, powders, etc. are handled, consideration must be given to high temperature, high humidity, generation of dust, or hygiene management. 2) Equipment used in social infrastructure such as factories is required to have performance such as automatic operation, trouble-free operation, easy preparation and setup changes. This enables us to provide society with high-quality, low-cost products and services. 3) When handling products with equipment, it is required to minimize the impact on product quality, such as damage or adhesion of foreign matter. From the above, the mechanical parts for sliding applications used in " Specialist equipment " are required to have the following properties. Repellency from water and oil / non-adhesion Low friction, self lubrication Heat resistance Chemical resistance (Acid resistance, Alkali resistance, Oil resistance, Ozon resistance) Table19 summarizes the performance of major alternative materials with respect to the required performance. 108 / 111 Table19 Material Material or Coating Low Coefficient friction of friction Repellency Contact from water angle of and oil water [deg] adhesion energy [dyne/cm] Oil Contained in resistance food Acid Contained in resistance food Alkali Contained in resistance detergents, etc. Ozon Special resistance cleaning Heat Hot food resistance PTFE Material/ Coating 0.04 114 43.1 POM Material 0.2~0.3 Equivalent to PA66 * Non-adhesion and Repellency from water and oil are HDPE Material/ Coating 0.2~0.3 88 75.2 ~ ~ according to the PA66 Material/ Coating 0.18~0.4 77 97.7 ~ above-mentioned property table. Others are summarized by the author of this section based on multiple documents. Appropriate materials are selected and used according to the required performance that varies depending on the work environment and target product. From the table, PFAS shows good properties with respect to water/oil repellency and heat resistance. Cases where PFAS is used as an irreplaceable material include, for example, use in environments where food and liquids are handled, as well as guide parts or blade surface coatings where adhesion is undesirable. Instrument example (Packaging machine for food industries) Figure 109 Heating pressure bar with knife of packaging machine (with PTFE Coating) 109 / 111 Food Contact Parts of Measuring Instruments The following performances are required for the food contact parts of measuring instruments for pre-packaging food. 1) Conformity with (EC) No 1935/2004, (EU) No 10/2011, etc. is required for safety when materials used are exposed to the body through food. 2) For the purpose of reducing food waste and cleaning burden, and ensuring supply by automating production, it is required that food does not adhere easily. There are two technical approaches to the anti-adhesion performance of 2). The first is "a) reducing the contact area with food" and the other is "b) using water- and oil-repellent, nonadhesive materials." The Table summarizes the performance of the main means currently in practical use considering the operating environment conditions. Each means is provided in the form of material or coating. Table20 Technical approach Means Material Repellency from water and oil Nonadhesion (for hard foods) Nonadhesion (for soft foods) Oil resistance Acid resistance Alkali resistance Ozon resistance Heat resistance Durability or Coating Does not adhere to water or oil Food does not remain on equipment. Contained in food Contained in food Contained in detergents, etc. Special cleaning Hot food Hard to wear (1)contact area Stainless steel embossed structure Material Oil hardens and accumulates. ~ ~ (2) water- and oil-repellent, non-adhesive materials PFAS(PTFE,PFA) Ceramic HDPE Material/Coating Coating ~ Material ~ ~ ~ 110 / 111 *PFAS and PE are according to the above-mentioned property table. SUS and ceramics are summarized by the author of this section based on multiple documents. In terms of technology in the practical stage, PFAS is superior in all items except durability. Since the required performance differs depending on the type of food and the factory environment, means other than PFAS may be selected. However, it is clear from the above table that substitution is not possible in all cases, which is the reason why exclusion is necessary. Also, the determination of substitutability must be tried in all cases using actual food in a real working environment, which is why the substitution period is necessary. Instrument example (Weigher for food industries) Example of oil accumulation (Food contact part is a flat stainless steel without coating) Example of stainless steel embossed structure Figure 110 111 / 111 Appendix 2 Essential Application This document is the appendix 2 of the general comment to the Restriction report on Per- and polyfluoroalkyl substances (PFAS) From NIPPON ELECTRIC CONTROL EQUIPMENT INDUSTRIES ASSOCIATION (NECA) submitted on 18. September 2023 Appendix 2 Essential Application 1. Safety switches...................................................................................................................................................... 2 2. Safety switches / Microswitch / Limit switch ........................................................................................................... 3 3. Safety switches...................................................................................................................................................... 4 4. Push-button switch / Microswitch / Limit switch...................................................................................................... 5 5. Push-button switch / Microswitch / Limit switch...................................................................................................... 6 6. Limit switch .......................................................................................................................................................... 7 7. Proximity switch ................................................................................................................................................... 9 8. Proximity switch ................................................................................................................................................. 10 9. Environment-resistant photoelectric switch with built-in amplifier .......................................................................... 13 10. External protection of liquid leak sensor................................................................................................................ 16 11. External protection of fiber unit for Measurement use ............................................................................................ 18 12. Hermetic seal for optical junction unit for vacuum environment .............................................................................. 21 13. Vibration Sensor .................................................................................................................................................. 23 14. Connector Cable .................................................................................................................................................. 25 15. Pressure Sensors .................................................................................................................................................. 28 16. Sapphire Capacitance Diaphragm Gauge ............................................................................................................... 29 17. Coating and protective covering for diaphragm of industrial pressure transmitter ..................................................... 31 18. Displacement measurement sensor ........................................................................................................................ 33 19. Displacement measurement sensor ........................................................................................................................ 35 20. Safety Sensor ...................................................................................................................................................... 38 21. Relay .................................................................................................................................................................. 40 22. Safety relay unit .................................................................................................................................................. 41 23. Safety Relay........................................................................................................................................................ 42 24. Programmable Logic Controller / Programmable Display ....................................................................................... 44 25. Terminal with communication function / Programmable display.............................................................................. 45 26. Image processing system...................................................................................................................................... 46 27. Coding for sliding rubber parts of industrial controllers .......................................................................................... 51 28. Temperature sensor.............................................................................................................................................. 52 29. Humidity sensor .................................................................................................................................................. 53 30. Safety controller .................................................................................................................................................. 55 31. Switching power supply / Transformer .................................................................................................................. 57 32. Measuring pipe lining material for industrial electromagnetic flowmeters ................................................................ 58 33. Fill Fluid for chlorine or oxygen pressure measurement.......................................................................................... 60 34. Mass Flow Controller seal .................................................................................................................................... 62 35. Mass Flow Controller lubricant oil ........................................................................................................................ 63 36. Control valve of mass flow controller.................................................................................................................... 64 37. Fittings for micro-flow rate liquid flow meter for semiconductor manufacturing process........................................... 66 38. Control valve seat ring ......................................................................................................................................... 68 39. Material for scraper rings in industrial control valves ............................................................................................. 70 40. Lining and throttling mechanism materials for industrial control valves ................................................................... 72 41. Valve for air volume and room pressure control ..................................................................................................... 74 42. RFID tag and antenna .......................................................................................................................................... 77 43. Ionizer ................................................................................................................................................................ 78 1 1. Safety switches Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Emergency stop pushbutton switch / A1201 Safety switches / A1202 Safety limit switches / A2401 9002-84-0, 69991-67-9, 60164-51-4, 1623-05-8, 25038-02-2 and more PTFE [Poly(tetrafluoroethylene)] PFPE [Perfluoropolyether] Same as above application Plunger, Cam, Contact 1. Sliding parts of internal switch 2. Contact coating Contact Plunger Cam Technical Description of Essential Uses Switches require mechanical durability and high reliability, so the sliding parts are coated with a fluorine-based lubricant to reduce frictional resistance. And it is used in coatings to protect contacts from dirt, reduce frictional resistance, and maintain high reliability. The technically difficult points of substitution are as follows. Abrasion powder is generated when resin/metal parts mechanically slide. Adhesion of abrasion powder to the contacts reduces the reliability of the contacts. Decrease in stability of Switch operation due to increased friction of sliding parts. 2 2. Safety switches / Microswitch / Limit switch Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Push-button switch / A1101 to A1104 Classification of NECA Microswitch / A2101 Limit switch / A2102 CAS RN 1-Propene, 1,1,2,3,3,3-hexafluoro-, oxidized, polymd. 69991-67-9 Regulated candidate PFPE (Perfluoropolyether) substance name Generic name for the Same as above application final product Common name for Plunger application parts Detailed application Sliding parts of internal switch description Plunger Technical Description of Essential Uses Switches require mechanical durability and high reliability, so the sliding parts are coated with a fluorine-based lubricant to reduce frictional resistance. The technically difficult points of substitution are as follows. Abrasion powder is generated when resin/metal parts mechanically slide. Adhesion of abrasion powder to the contacts reduces the reliability of the contacts. Decrease in stability of Switch operation due to increased friction of sliding parts. 3 3. Safety switches Essential Application Main use sector Application/ Classification of NECA Application CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Emergency stop pushbutton switch / A1201 Safety switches / A1202 Safety limit switches / A2401 Safety switches 9011-17-0 FKM [1,1-Difluorethylene-hexafluorpropene polymer] Same as above application O-ring < Sliding / Seal parts of internal switches > O-ring Technical Description of Essential Uses Switches use rubber parts such as O-rings to ensure a protective structure. The technically difficult points of substitution are as follows. High oil resistance and chemical resistance are required. Harmful outgassing must not occur at the contact. 4 4. Push-button switch / Microswitch / Limit switch Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Push-button switch / A1101 to A1104 Classification of NECA Microswitch / A2101 Limit switch / A2102 CAS RN 9002-84-0 Polymer of 1,1,2,2-tetrafluoroethene 9002-83-9 Ethene, 1-chloro-1,2,2-trifluoro-, homopolymer 163702-08-7 Methyl perfluorobuthyl ether 69991-61-3 Ethene, 1,1,2,2-tetrafluoro-, oxidized, polymd. Regulated candidate Fluorine grease / PAO grease / Fluororesin substance name Generic name for the Same as above application final product Common name for Fluorine grease / PAO grease / Fluororesin application parts Detailed application Used for the sliding part inside the switch description Grease Technical Description of Essential Uses In order to ensure high durability, the switch applies grease to the sliding parts of the parts. Resin parts with excellent slidability are sometimes used. The technically difficult points of substitution are as follows. If grease is not applied, parts will be seized and high durability cannot be achieved. High heat resistance and chemical resistance are required depending on the usage environment of the customer. Harmful outgas must not be generated at the contact. 5 5. Push-button switch / Microswitch / Limit switch Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Push-button switch / A1101 to A1104 Classification of NECA Microswitch / A2101 Limit switch / A2102 CAS RN <THV> 116-14-3 Ethene, tetrafluoro- 25067-11-2 Polymer of 1,1,2,3,3,3-hexafluoroprop-1-ene / 1,1,2,2-tetrafluoroethene 25190-89-0 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and 1,1,2,2- tetrafluoroethene < O-ring > 9011-17-0 1,1-Difluorethylene-hexafluorpropene polymer Regulated candidate [Cable] THV substance name [O-ring] FKM fluorine rubber Generic name for the Same as above application final product Common name for Cable / O-ring application parts Detailed application 1. Used for the cable of Switch description 2. Used for the O-ring of Seal parts << Schematic Cross-sectional View >> Cable 1) Cable Fluororesin, which is less likely to be deteriorated by either 7-insoluble or water-soluble cutting oils, is used for the cable sheath. This prevents penetration of cutting oils into the cable. 2) O-ring HNBR+ fluorine rubber kneading, which is less likely to be deteriorated by either waterinsoluble or water-soluble cutting oils, is used for the O-ring. This prevents penetration of cutting oils into the connector. In addition, fluorine coating on the O-ring improves assembly and slidability. 6 6. Limit switch Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Limit switch / A2102 9002-84-0 75-38-7 Polymeric PFAS / PTFE, FKM Limit switch Internal switch button (PTFE) Painting the housing (PTFE) Rubber seal (FKM) 1. Internal switch button 2. Painting the housing 3. Used for each rubber seal of limit switch Technical Description of Essential Uses Although the exterior coating can be changed to other coatings, fluorine is the lowest and most suitable for internal sliding properties. Sliding : plunger and housing Sliding: internal switch button and internal switch cover Addition of fluorine improves slidability. Dynamic friction coefficient (ud) Heat-resistant(C) Fluoropolymer PTFE 0.09 260 Resin PE 0.13 70-110 POM 0.18 80-120 The retention of seals at high temperatures is superior to other rubbers. 7 Figure: Heat resistance of various rubbers (after aging for 24 hours at each temperature) Figure: Seal performance retention of various rubbers (%) at 150C Refer: https://www.packing.co.jp/GOMU/GOMU1/fkm.htm Sliding performance chemical resistance Heat-resistant Seal retention performance at high temperature Required derogation period Socio-economic impact Switching to silicone rubber is difficult to adopt because of the risk of contact failure. In addition, it is often used for applications such as cutting fluid that damage silicon rubber, so it cannot be used. Wear resistance due to sliding, sliding performance. Resistance to water-soluble coolants (basic) used in machine tools and automotive parts processing lines Heat resistance that can withstand continuous use in a 120C environment The ability to maintain the seal under the conditions of 120C 13.5 years or more Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 8 7. Proximity switch Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Proximity switch / A2201 Unidentified Fluororesin PFA Fluororesin coating Spatter-guarded proximity switch Cap Housing Part of the housing of the spatter-guarded proximity switch used in a welding environment. Cap : Fluororesin PFA sensing surface Housing : Coated with fluororesin. Housing Cap Spatter-guarded proximity switch Technical Description of Essential Uses Heat-resistant No-adhesion Required derogation period Socio-economic impact The following features can be obtained by using Fluororesin. Cap : It can withstand the heat of welding spatter. By making spatter less likely to adhere, reducing malfunctions and improving maintainability Housing : It is difficult for spatter to stick. Heat resistant temperature: about 260C Prevention of adhesion of welding spatter 13.5 years or more Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 9 8. Proximity switch Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Proximity sensor / A2201 9002-84-0, 26655-00-5, 25190-89-0, 116-14-3 Polymer of 1,1,2,2-tetrafluoroethene Polymer of 1,1,1,2,2,3,3-heptafluoro-3 -[(1,2,2-trifluorovinyl)oxy]propane / 1,1,2,2-tetrafluoroethene 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1, difluoroethane and 1,1,2,2-tetrafluoroethene Ethene, tetrafluoroSame as above application As its usage differs by product series of Proximity Sensors, categorized into 1 to 3. (1) Oil resistance 1-1 : Parts connecting cable, 1-2 : Cable sheath (2) Spatter resistance 2-1 : Cap, 2-2 : Case, 2-3 : Clamping nuts (3) Chemical resistance 3-1 : Case, 3-2 : Cable clamp, 3-3 : Clamping nuts Detailed application description (1) Oil resistance Proximity Sensor 1-1:Parts connecting cable 1-2:Cable sheath The product is mainly used in the processes of cutting and polishing parts in automobile industry, and fluorine coating is used to prevent the joint of sensor cables and sensor from being degraded by cutting oil. 1-1 Parts connecting cable and sensor: Fluororesin parts which connects the cable and sensor 1-2 Cable sheath: Cable which sheath is made of fluororesin 10 (2) Spatter-resistant Proximity Sensor 2-1:Cap 2-3:Clamping nuts 2-2:Case The product is mainly used in the welding process in the automobile industry, and fluorine coating is used for the outer parts to prevent spatters (molten iron) from adhering to the sensor. 2-1 Cap: Fluororesin parts 2-2 Case: Metal parts with fluororesin coating 2-3 Clamping nuts: Metal parts with fluororesin coating (3) Chemical-resistant Proximity Sensor 3-1:Case 3-3:Clamping nuts 3-2:Cable clamp Technical Description of Essential Uses Fluororesin coating is used for the outer parts to prevent applicable part from corroding by detergent for equipment cleaning in the production processes of food, pharmaceutical, and cosmetics industries. 3-1 Case: Fluororesin parts 3-2 Cable clamp: Fluororesin parts 3-3 Clamping nuts: Clamping nuts made of fluororesin (1) Oil-resistance Proximity Sensor Proximity Sensors are usually installed inside of cutting and polishing machines and subject to spillage of cutting oil on a constant basis. PVC and PUR cables are not resistant enough under such environment. There is no material that can substitute fluorine which has excellent cutting oil resistance and flexibility. 11 (2) Spatter-resistant Proximity Sensor Proximity Sensors are usually installed near welding machines and used in environment where spatters scatter and adheres to the Sensor. In such environment, there is coating such as silicone coating for outer case and clamping nuts; however, since spatter resistance is lower, the failure cycle of the Sensors becomes faster, and it decreases our customer's productivity. In terms of the cap, in addition to spatter resistance, special chemical surface finishing is performed to join the resin filled inside in the production process of the Sensors. There is no alternative material for fluorine including this processing. (3) Chemical-resistant Proximity Sensor Oil resistance Flexibility Spatter resistance Chemical resistance Equipment which Proximity Sensors are installed is cleaned using detergent for hygienic management. Since detergent is poured on the Proximity Sensors during equipment cleaning, resistant to such detergent is required. Fluorine used for outer parts is required to have corrosion resistance, chemical resistance and heat resistance. Additionally, special chemical surface finishing is performed to join the resin filled inside in the production process of the Sensors. There is no alternative material for fluorine including this processing. (1) Oil resistance which oil does not penetrate inside the Sensor in the internal acceleration test (Dipping in water-soluble cutting oil with 55 degrees C for 2000 hours) is required. For cables, penetration must be within about 0.3mm. (1) As cable is bent to wire to equipment, flexibility which can be bent at 25mm of bend radius is required. Young's modulus of approximately 200 MPa (2) Oil/water repellency that does not allow malfunction of the Sensors when spatters adhere to the Sensors due to degradation of the coating in the test using actual product which applies spatters is required. Continuous use temperature: Approximately 220C or higher, and contact angle with water is approximately 100 to 110 (3) Chemical resistance that corrosion and degradation do not occur even when exposed to detergent and chemical solutions is required. Typical evaluation conditions are as follows. NaOH concentration 1.5% 70C 240 hours H3PO4 concentration 1.5% 70C 240 hours H2O2 concentration 6.5% 70C 240 hours 12 9. Environment-resistant photoelectric switch with built-in amplifier Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Environment-resistant photoelectric switch with built-in amplifier / A2202 Classification of NECA CAS RN Regulated candidate substance name Unidentified Polymeric PFAS paint / PTFE, FEP Generic name for the Environment-resistant photoelectric switch with built-in amplifier. final product Common name for Housing made of zinc alloy coated with fluorocarbon resin. application parts Detailed application description The Housing coated with fluorocarbon resin. Fittings for fixing built-in parts Fig.1 External view Water-soluble coolant switch switch Fig. 2 Detection of workpiece seating in machine tool The housing of the environment-resistant photoelectric switch is coated with fluorine paint (Fig. 1). There are two purposes of fluoride coating. 1. Improved corrosion resistance of housing The housing of Environment-resistant photoelectric switch is made of zinc die-cast. Zinc 13 die-casting has advantages such as high fluidity, easy dimensional accuracy, low molding temperature, and long service life of metal mold, but it has low corrosion resistance. Therefore, it cannot be used in machine tools and automobile parts machining lines, which are users of this switch, unless corrosion resistance is improved by painting and plating. Water-soluble coolant (basic) is often used in machine tools and automobile parts machining lines, and zinc die-cast housing is highly likely to be corroded unless surface treatment such as painting is performed (Fig. 2). switch Fig. 3 Confirmation of Existence of Tool in Machine Tool 2. Prevention of crevice corrosion and dissimilar metal contact corrosion The housing is assembled with a metal stopper (SUS plate (zinc plated)) (Fig. 1) and attached to an accessory SUS bracket or the mounting surface of the user side (metal, resin, etc., materials cannot be specified) (Fig. 3). Therefore, it is necessary that the metal surface of the housing is not exposed in order to prevent electrolytic corrosion due to gap corrosion and contact between different metals. Technical Description of Essential Uses The former model number of this switch had adopted acrylic coating, but it was changed to fluorine coating due to low resistance to water-soluble coolant. The surface of the housing must be free from exposed metal. Therefore, coating by coating is necessary instead of plating. For the same reason, coating is necessary even if the housing is changed to a highly corrosion resistant metal material such as SUS. There are concerns about the following impacts due to the unavailability of this technology 14  Affects machining with machine tools that use water-soluble coolant and parts machining and production on automotive parts production lines There is no alternative technology. When a switch without fluorine coating is used, corrosion of the switch causes contamination of corrosion products (foreign matter) into parts, generation of rust in processed parts, and increase of stoppage period of machine tools and production lines due to increase of sensor replacement frequency. chemical resistance Required derogation period Socio-economic impact For the above-mentioned reasons, the prohibition of coatings with fluorine-based paints should be exempted indefinitely from this restriction because of the economic burden due to the increased frequency of replacement and the serious degradation to the finished product. In terms of disposal, restrictions should not be applied as coatings by fluorinated paints generally lead to a reduction in waste. Resistance to water-soluble coolants (basic) used in machine tools and automotive parts processing lines 13.5 years or more Note: This application should have the same derogation period as petroleum and mining. Problem with the safety of the worker. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 15 10. External protection of liquid leak sensor Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ External protection of liquid leak sensor / A2202 Classification of NECA CAS RN Regulated candidate substance name 26655-00-5 Polymeric PFAS / PFA Generic name for the Liquid leak sensor final product Common name for housing application parts Detailed application description This leakage sensor is used for the following applications. - Liquid leakage detection in semiconductor wafer cleaning and developing processes - Detection of tank leakage Liquid tank Liquid leak sensor The sensor housing is made of PFA resin. Schematic diagram of sensor structure The sensor housing cover, case and tube are made of PFA resin. 16 Technical Description of Essential Uses Due to the housing made of PFA resin, this leakage sensor has higher stability against organic solvents than other products. The following characteristics can be obtained by using PFA resin for the leakage sensor. - This leakage sensor functions stably for the detection of organic solvents. - There is no alternative to this function This leakage sensor is used for the following applications. - Liquid leakage detection in semiconductor wafer cleaning and developing processes - Detection of tank leakage There are concerns about the following effects due to the unavailability of this technology : - Cleaning and development of a semiconductor wafer using an organic solvent cannot be carried out safely. Chemical resistance Cleanliness performance Required derogation period Socio-economic impact For the above reasons, the prohibition of PFA resin in leakage sensors affects safety and should be exempted from this restriction indefinitely. Resistant to chemicals and solvents fluids Cleanliness performance without elution and volatilization of components from components 13.5 years or more Note: This application should have the same derogation period as semiconductor manufacturing processes. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. Yield deterioration in the semiconductor manufacturing process 17 11. External protection of fiber unit for Measurement use Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ External protection of fiber unit for Measurement use / A2202 Classification of NECA CAS RN 25067-11-2 26655-00-5 Regulated candidate Polymeric PFAS / substance name FEP, PFA Generic name for the Fiber unit final product Common name for housing and tube application parts Detailed application description Fiber unit with chemical Liquid detection This sensor is used for the following applications. Liquid leakage detection in semiconductor wafer cleaning and developing processes Detection of tank leakage Passage detection in places where there is a possibility of contact with chemical liquid [Be included in the component] : Parts that are in an inseparable composite state at the time of purchase Plastic Optical Fiber Used as a component of the following fiber unit Fluorine resin With FEP and PFA Structure This is a step index type multimode fiber (using the refractive index difference between core and clad). Fluorine resin is used for the clad. No alternative material has been proposed by the manufacturer at present. In this type of fiber, the basic optical characteristics of the fiber are determined by the refractive index difference between core material and clad material, and the material is selected by the manufacturer in consideration of the manufacturing method. Users use commercially available fiber. FEP is used for the clad and jacket, and PFA is used for the jacket and outer coating. [Products : fiber units] Detection method and part of use Purpose and materials used Principle using PFA characteristics Liquid level detection The tip detection part is Use refractive index difference PFA made of PFA, and the tube between PFA and liquid material which may come PFA into contact with liquid is also covered with PFA, a material which is easily fused with the tip. In order to make the tip Detector is PFA No Liquid (Incoming Light) With Liquid (Light Shielding) Detection part small and non-electric, a commercially available It uses the difference in refractive index between liquid and liquid. plastic optical fiber cable is 18 Leak detection Chemical resistance PFA PFA cover Transparent example PFA PFA used for guiding the detection light, and fluorine resin (specific material is not disclosed by the manufacturer) is also used as the clad material. The detection head and cable, which may come into contact with liquid, are covered with PFA. Detection principle It utilizes the return light difference due to the refractive index difference (hereinafter referred to as n) between the material of the tip cone and the external contact material. Without liquid : In a state of lower refractive index than PFA (n ~ 1.35) (air n ~ 1), most of the light emitted from the projection is reflected by the inner surface of the cone and returns to the light receiving portion to enter. Liquid : The liquid has a large refractive index equal to or higher than that of PFA (water n ~ 1.33, ethyl alcohol n ~ 1.36), and the amount of light that is substantially transmitted through the conical surface and returns to the light receiving portion decreases. The presence or absence of liquid is determined by this light amount difference. Use refractive index difference between PFA and liquid The detection head and cable, which may come into contact with liquid, are covered with PFA. Detection principle is the same as "liquid level detection" Sealing performance is ensured by fusing the tip of the PFA detection head and the tube. PFA Technical Description of Essential Uses Due to the housing made of PFA resin, this fiber unit has higher stability against organic solvents than other products. The following characteristics can be obtained by using PFA resin for the fiber unit. 19 - This fiber unit functions stably for the detection of organic solvents. - There is no alternative to this function This leakage sensor is used for the following applications. - Liquid leakage detection in semiconductor wafer cleaning and developing processes - Detection of tank leakage There are concerns about the following effects due to the unavailability of this technology : - Cleaning and development of a semiconductor wafer using an organic solvent cannot be carried out safely. Chemical resistance Cleanliness performance Required derogation period Socio-economic impact For the above reasons, the prohibition of PFA resin in leakage sensors affects safety and should be exempted from this restriction indefinitely. Resistant to chemicals and solvents fluids Cleanliness performance without elution and volatilization of components from components 13.5 years or more Note: This application should have the same derogation period as semiconductor manufacturing processes. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. Yield deterioration in the semiconductor manufacturing process 20 12. Hermetic seal for optical junction unit for vacuum environment Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Hermetic seal for optical junction unit for vacuum environment / A2202 Classification of NECA CAS RN Regulated candidate substance name Unidentified Polymeric PFAS / Fluorocarbon rubber Generic name for the Junction unit for vacuum environment final product Common name for O-ring application parts Detailed application Optical junction unit for vacuum environment are used for photoelectric sensors that enable description detection in vacuum chambers in the semiconductor and LCD manufacturing processes. Junction unit for vacuum environment is used for a photoelectric sensor that enables detection inside a vacuum chamber by transmitting light from a fiber amplifier through a fiber unit. PFAS is used in O-ring for seal for air and vacuum environment. The optical coupler is provided with sealing ability to pass the detection light through the wall of the vacuum device. The O-ring for sealing is made of fluorine rubber to keep high temperature, high seal and high cleanliness. VACUUM CHAMBER Enlarged view VACUUM CHAMBER Junction unit Fig. Optical junction unit for vacuum 21 Technical Description of Essential Uses Heat-resistant Cleanliness performance Required derogation period Socio-economic impact To keep high temperature, high seal, and high cleanliness in a vacuum environment, materials other than fluorocarbon rubber are not appropriate. Heat resistance to withstand 200C Cleanliness performance without elution and volatilization of components from components 13.5 years or more Note: This application should have the same derogation period as semiconductor manufacturing processes. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. Yield deterioration in the semiconductor manufacturing process 22 13. Vibration Sensor Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Vibration Sensor / A2299 Unidentified Cable : THV, ETFE, PTFE O-ring : FKM, HNBR FH-11-65 Sealing rubber : FH-11-65 Same as above application Oil-resistant cable, O-ring, Sealing rubber (1) Used in the cable for Vibration Sensor (2) Used in the sealing between the housing case and wires (3) Used in the sealing between the housing case and base Oil-resistant cable Sealing rubber O-ring 23 Technical Description of Essential Uses (1) Cable Fluororesin which has resistance to both water-insoluble and water-soluble cutting oil is used in the cable sheath. This prevents the cutting oil from penetrating inside of the cable. (2) Sealing rubber Fluororesin which has resistance to both water-insoluble and water-soluble cutting oil is used in the sealing rubber. This prevents the cutting oil from penetrating inside of the cable. (3) O-ring Fluororesin which has resistance to both water-insoluble and water-soluble cutting oil is used in the O-ring. This prevents the cutting oil from penetrating inside of the cable. 24 14. Connector Cable Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Connector Cable / A2299 Unidentified [Cable] THV, ETFE, PTFE, Soft fluoropolymer [O-ring] FKM, HNBR + fluororubber Circular Connector Cable 1. Cable 2. O-ring 1.Used for the cable of both Socket Connector Cable and Plug Connector Cable 2.Used for the O-ring of Socket Connector Cable << Exterior photo >> Socket Connector Cable Plug Connector Cable << Schematic Cross-sectional View >> 3) Cable Fluororesin, which is less likely to be deteriorated by either water-insoluble or watersoluble cutting oils, is used for the cable sheath. This prevents penetration of cutting oils into the cable. 25 4) O-ring HNBR+ fluorine rubber kneading, which is less likely to be deteriorated by either waterinsoluble or water-soluble cutting oils, is used for the O-ring. This prevents penetration of cutting oils into the connector. << Product usage examples >> Used in combination with proximity sensors for cylinder detection in machine tools, etc. Water-soluble coolant Proximity sensor Connector Cable Technical Description of Essential Uses 1.Cable Fluorine cable is used to maintain oil resistance. It is difficult to substitute anything other than fluorine. 2. O-ring Fluororubber is used to maintain oil and adhesive resistance. It is difficult to substitute anything other than fluorine. Chemical resistance Water repellency / oil resistance We have a track record of being used in the customer's on-site environment (acidic and alkaline atmosphere). As a robust component product, we do not guarantee it, but the catalog shows that it does not deteriorate for more than 4 years of oil resistance. 26 << Catalog >> 27 15. Pressure Sensors Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Medical devices (Annex E.2.9.) Electronics and semiconductors (Annex E.2.11.) etc. Pressure Sensors / A2301 9011-17-0 FKM (fluororubber) Pressure Sensors O-ring Guard plate for switches FKM (fluororubber) is used as the material for the O-rings and guard plate for switches to prevent the liquid being measured from entering the inside of the product. O-ring Guard plate for switches O-ring OO-ring Technical Description of Essential Uses As this is a general-purpose senser, substances to be measured are not known. Therefore, FKM (fluororubber) which has excellent characteristics such as oil resistance, chemical resistance, and solvent resistance and is well-balanced between workability and cost is used. 28 16. Sapphire Capacitance Diaphragm Gauge Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Sapphire Capacitance Diaphragm Gauge / A2301 Classification of NECA CAS RN Unidentified Regulated candidate Polymeric PFAS / substance name FKM, PFA, TFE, PTFE Generic name for the Sapphire Capacitance Diaphragm Gauge final product Common name for Thermal insulation and Cable application parts Detailed application description The sapphire capacitance diaphragm gauge is used in deposition equipment and etching equipment in the semiconductor manufacturing process. Integrated Model Components corresponding to a heater operating temperature of MAX 250C thermal insulation cap thermal insulation case Contains Fluororubber(FKM) Sensor Board connection cable Sheath, insulator, etc. contain Perfluoroalkoxy alkane (PFA) Temperature sensor for control Heat shrink tubing, cable coating, etc. contain Perfluoroalkoxy alkane (PFA, PFE) Heater board connection cable and thermistor Thermistor heat shrink tubing, cable coating, etc. contain Perfluoroalkoxy alkane (PFA, TFE, PTFE) Heater board connection cable Thermistor 29 Separated Model Components compatible with gauge head operating temperature of MAX 250C LEMO connector Board connection cable Cable jacket and dielectric contain Perfluoroalkoxy alkane (PFA) Sensor, Temperature sensor for control Board connection cable Sheath, insulator, etc. contain Perfluoroalkoxy alkane (PFA) Technical Description of Essential Uses Heat-resistant Required derogation period Socio-economic impact There is no fluorine-free material with equivalent heat resistance. Heat resistance to withstand 250C 13.5 years or more Note: This application should have the same derogation period as semiconductor manufacturing processes. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. Yield deterioration in the semiconductor manufacturing process 30 17. Coating and protective covering for diaphragm of industrial pressure transmitter Essential Application Main use sector Energy sector (Annex E.2.12.) Petroleum and mining (Annex E.2.15.) etc. Application/ Coating and protective covering for diaphragm of industrial pressure transmitter / A2301 Classification of NECA CAS RN FEP : 25067-11-2 PFA : 26655-00-5 PCTFE : 25038-89-5 PTFE : 9002-84-0 Regulated candidate Polymeric PFAS / FEP, PFA, PCTFE, PTFE substance name Generic name for the Industrial pressure transmitter final product Common name for Diaphragm, Flange application parts Detailed application description Pressure transmitter Diaphragm/wetted parts coating Technical Description of Essential Uses Industrial pressure transmitters are instruments used for measuring pressure in pipes and tanks, particularly in applications that require flow or liquid level measurement. They are commonly utilized in various large-scale equipment, such as industrial chemical plants. Industrial pressure transmitters are used to measure corrosive fluids such as chemicals. The measurement of corrosive fluids such as chemicals accounts for 10% of all industrial pressure transmitter applications. Industrial pressure transmitters are required to have the performance to withstand the measurement of these corrosive fluids. To measure corrosive fluids with industrial pressure transmitters, coatings and protective films such as FEP are required on the parts that come into contact with corrosive fluids. As an alternative to coatings such as FEP, there is a possibility that resin coatings such as epoxy can be used. However, substitute materials are poorly resistant to various chemicals in industrial chemical plants and cannot withstand corrosive fluids. 31  With alternative technologies and materials, the pressure transmitter itself connected to the piping must be replaced periodically by shutting down the facility or every time corrosion of the wetted parts occurs, which could be as early as every few months. Pressure transmitters with diaphragm coatings and protective films using FEP etc. can operate stably for at least 10 years without replacement. There are concerns about the following impacts due to the unavailability of this technology The unavailability of FEP etc. for diaphragm coatings and protective coatings for industrial pressure transmitters will affect the production and supply of chemical products by significantly reducing production efficiency in plants producing corrosive fluids such as chemicals Chemical resistance Required derogation period Socio-economic impact For the above reasons, the prohibition of coating and protective films of diaphragms by FEP etc. on industrial pressure transmitters should be exempted indefinitely from this restriction because of the economic burden caused by the increased frequency of replacement due to equipment shutdown. From the viewpoint of disposal, restrictions should not be applied because the diaphragm coating and protective film of FEP etc. for industrial pressure transmitters allow the pressure transmitter to be used until it reaches its original service life, which generally leads to a reduction in waste. Corrosion resistance with corrosive fluids 13.5 years or more Note: This application should have the same derogation period as petroleum and mining. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 32 18. Displacement measurement sensor Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Displacement measurement sensor / A2302 Classification of NECA CAS RN 647-42-7 Regulated candidate 3,3,4,4,5,5,6,6,7,7,8,8,8-Tridecafluorooctanol substance name Generic name for the Same as above application final product Common name for Diffractive Lens application parts Detailed application Fig. 1 shows the appearance of the displacement measurement sensor. This sensor is a description displacement sensor based on the chromatic confocal method, and the material that is targeted for regulation this time is used in the diffractive lens, which is the core optical component of this sensor. Fig. 2 shows an outline of the optical system inside the housing. A diffractive lens can diffract white light, and the light beam angle can be changed for each wavelength. And this precisely conversion (wavelength to angle) directly affects the performance of the sensor. *The chromatic confocal method: One of the principle of the displacement measurement that white light is irradiated to the object to be measured by changing the focus position for each color (wavelength), and only the focused wavelength light is received as reflected light, and the height is determined. housing Objective lens Fig.1 the appearance of the displacement measurement sensor 33 diffractive lens housing Objective lens Fig.2 an outline of the optical system inside the housing Technical Description of Essential Uses Without using a diffractive lens, the principle of measurement of this sensor cannot be worked. For the displacement measurement sensor based on the chromatic confocal method, it is essential for using the diffraction lens to change the focus position on the object to be measured for each wavelength. So, it is extremely difficult to realize a sensor of this method without using a diffractive lens. Low friction / Wear resistance Heat-resistant Light fastness / Weather fastness Low refractive index Other characteristics Alternative material The diffractive surface cannot be molded without using this material. Diffractive lens controls the direction of light by means of a diffraction phenomenon caused by extremely fine and complicated structures of nm (nano meter) order on the optical surface. It is extremely difficult to replace the material of the diffractive lens, because it is a dedicated material designed in consideration of the moldability of diffractive surface, releasability, refractive index, Abbe number, phase information, the long-term reliability and so on. Adhere cellophane tape (Nichiban No.405) to the diffractive surface and instantly remove it in the vertical direction. After repeating the operation three times, the resin layer should not peel off. High temperature and high humidity: No deterioration after left at 65C, RH85%, 1000H Low temperature storage: No deterioration after 1000 hours storage at -15C Thermal shock: -15C to 60C No deterioration after 100 cycles Wavelength 400 to 700nm, 1mW, no deterioration after 7 years or more irradiation Refractive index designed value +/- 0.001 accuracy Improved releasability during molding None *As described in the non-substitution explanation above. 34 19. Displacement measurement sensor Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Displacement measurement sensor / A2302 Classification of NECA CAS RN 647-42-7 Regulated candidate 3,3,4,4,5,5,6,6,7,7,8,8,8-Tridecafluorooctanol substance name Generic name for the Same as above application final product Common name for Hybrid lens application parts Detailed application Fig. 1 shows the appearance of the displacement sensor. The sensor is a triangulation-based description displacement sensor, and the material that is targeted for regulation this time is used in the light-projecting lens and the light-receiving lens, which are the core optical components of this sensor. Fig. 2 shows an outline of the optical system inside the housing. The light emitted from the semiconductor laser is condensed on the surface of the object to be measured by the projection lens, and the reflected light from the object to be measured forms an image on the light receiving element via the light receiving lens. The height is measured by changing the imaging position on the light receiving element according to the distance from the housing surface to the object to be measured. The quality of collected light through the projection lens and receiving lens are extremely important factor that determine the performance in this type of the displacement measurement sensor. A dedicated lens design is required to improve these light collection qualities. Of these, the aberration of the optical system (lens) is important as a design index for improving the light collection quality. Reducing aberrations improves the quality of light collection of the lens. There are two main ways to reduce aberrations. (1) Use an aspherical lens (2) Combine multiple spherical lenses. If (2) is selected, the size of the optical system becomes large, which leads to an increase in housing size and cost. So, the aspherical lens is used in this sensor. As the name suggests, an aspherical lens has a complex aspherical shape rather than a spherical surface. In order to realize this complex shape, the material that is targeted for regulation this time is necessary. 35 projection window light receiving window housing Fig.1 the appearance of the displacement sensor Semiconductor laser light receiving element projection lens Projection window light receiving lens light receiving window housing Fig.2 an outline of the optical system inside the housing Technical Description of Essential Uses The aspherical shape cannot be molded without using this material. Aspherical lens reduces lens aberration by forming an optical surface into a complex curved shape represented by a polynomial. Realization of this complex shape requires advanced molding technology and material properties customized for this application. Design information of the aspherical surface (material refractive index, Abbe number, curved surface shape, etc.) and moldability (especially, if it is not included the materials, the releasability deteriorates and the desired shape cannot be obtained), and it is extremely difficult to replace it with other materials because it is a dedicated material designed in consideration of long-term reliability in the environment where the displacement sensor is used. Low friction / Wear resistance Adhere cellophane tape (Nichiban No.405) to the diffractive surface and instantly remove it in the vertical direction. After repeating the operation three times, the resin layer should not 36 Heat-resistant Light fastness / Weather fastness Low refractive index Other characteristics Alternative material peel off. High temperature and high humidity: No deterioration after 70C, RH95%, 1000H Low temperature storage: No deterioration after 1000 hours storage at -15C Thermal shock: -15C to 70C No deterioration after 100 cycles Wavelength 660+/-20nm,1mw, no deterioration after 7 years or more irradiation Refractive index designed value +/- 0.001 accuracy Improved releasability during molding None *As described in the non-substitution explanation above. 37 20. Safety Sensor Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Safety Sensor / A2402 113114-19-5, 116-14-3, 1478-61-1, 25038-71-5, 25190-89-0, 27029-05-6, 9002-84-0 - Fluorinated polymer of 2,2,3,3-tetrafluorooxetane - Tetrafluoroethylene - Bisphenol AF - Ethene, 1,1,2,2-tetrafluoro-, polymer with ethene - Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and 1,1,2,2tetrafluoroethene - 1-Propene, polymer with 1,1,2,2-tetrafluoroethene - PTFE Same as above application Cable sheath, Insulator, Tape, Gasket, O-ring, Sponge Cable wish Connector Safety Sensor Cable sheath Insulator Tape Gasket O-ring Sponge To ensure environmental resistance, the parts that make up the cables of the safety sensor and the parts that make up the protective structure are used. 38 Technical Description of Essential Uses Water repellency/ oil repellency Difficulty in replacing In some cases, the safety sensor is installed near the extraction port of the processing machine and is exposed to oil mist. In harsh environments, NBR and other materials are not sufficient, and it has become difficult to substitute materials other than fluorine processed materials as materials that are resistant to cutting oil. No failure even in a coolant-contaminated environment. When substituted with NBR or H-NBR, the physical properties change with cutting oil, causing cutting oil penetration and insufficient sealing pressure in the seal rubber. 39 21. Relay Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Electronics and semiconductors (Annex E.2.11.) etc. Relay / B1101 Unidentified PFPE [Perfluoropolyether] Relay Indicator, Armature + Yoke 1. Sliding parts of internal relay Indicator Armature + Yoke Sliding part Technical Description of Essential Uses Since relays are required to have high mechanical durability and high reliability, sliding parts are coated with a fluorine-based lubricant for the purpose of reducing frictional resistance. The technically difficult points of substitution are as follows. Because relay has contacts structure, contact reliability is reduced due to abrasion powder generated when plastic or metal parts mechanically operate. Decrease in stability of relay operation due to increased friction of sliding parts. Fluorinated lubricants are commonly used in several relays because they can be easily diluted with similar fluorinated solvents and can be applied evenly and easily dried. 40 22. Safety relay unit Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Safety relay unit / B1202 69991-67-9, 60164-51-4, 1623-05-8, 25038-02-2 and more PFPE [Perfluoropolyether] Same as above application Safety relay Safety relay unit Safety relay Internal Sliding points Card It is used to reduce frictional resistance on the sliding part (card) of the safety relay built into the safety relay unit to achieve high mechanical durability and reliability. Technical Description of Essential Uses Low friction/wear resistant Remarks The technically difficult points of substitution are as follows. Fluorinated lubricants are commonly used in several relays because they can be easily diluted with similar fluorinated solvents and can be applied evenly and easily dried. Because relay has contacts structure, contact reliability is reduced due to abrasion powder generated when plastic or metal parts mechanically operate. Decrease in stability of relay operation due to increased friction of sliding parts. When parts slide, there is no generation of abrasion powder that causes poor contact of contacts. Since this product relies on the built-in safety relay, please also refer to the application material for the safety relay. 41 23. Safety Relay Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Safety Relay / B1201 69991-67-9, 60164-51-4, 1623-05-8, 25038-02-2 and more PFPE [Perfluoropolyether] Same as above application Card, Contact 1. Sliding parts of internal relay 2. Contact coating Card <Internal structure> Sliding points Contact Technical Description of Essential Uses Since relays are required to have high mechanical durability and high reliability, sliding parts are coated with a fluorine-based lubricant for the purpose of reducing frictional resistance. And it is used in coatings to protect contacts from dirt, reduce frictional resistance, and maintain high reliability. The technically difficult points of substitution are as follows. Because relay has contacts structure, contact reliability is reduced due to abrasion powder generated when plastic or metal parts mechanically operate. Decrease in stability of relay operation due to increased friction of sliding parts. 42  Fluorinated lubricants are commonly used in several relays because they can be easily diluted with similar fluorinated solvents and can be applied evenly and easily dried. 43 24. Programmable Logic Controller / Programmable Display Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Programmable Logic Controller / B2101 Classification of NECA Programmable Display / B2201, B2299 CAS RN Unidentified Regulated candidate PFPE (Perfluoropolyether) substance name Generic name for the Same as above application final product Common name for Relay / B1101 application parts Safety Relay / B1201 Detailed application description Programmable Logic Controller Relay Internal Internal Technical Description of Essential Uses It is used to reduce frictional resistance on the sliding part of the relay built into the programmable logic controller to achieve high mechanical durability and reliability. Since relays are required to have high mechanical durability and high reliability, sliding parts are coated with a fluorine-based lubricant for the purpose of reducing frictional resistance. Remarks The technically difficult points of substitution are as follows. Because relay has contacts structure, contact reliability is reduced due to abrasion powder generated when plastic or metal parts mechanically operate. Decrease in stability of relay operation due to increased friction of sliding parts. Fluorinated lubricants are commonly used in several relays because they can be easily diluted with similar fluorinated solvents and can be applied evenly and easily dried. Since this product relies on the built-in relay, please also refer to the application material for the relay. 44 25. Terminal with communication function / Programmable display Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ Terminal with communication function / B2301 Classification of NECA Programmable display / B2201 CAS RN Unidentified Regulated candidate Fluororubber substance name Generic name for the Same as above application final product Common name for O-ring, Waterproof packing application parts Detailed application A waterproof structure is created by sandwiching it between two housings and crushing it description with the upper and lower housings. Some oil-resistant products use fluororubber to improve oil resistance and chemical resistance. Housing Waterproof packing O-ring Technical Description of Essential Uses Fluorine is generally used in products that improve chemical resistance, water repellency, and oil resistance. 45 26. Image processing system Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Image processing system / B2401 Classification of NECA CAS RN Unidentified Regulated candidate PFAS substance name Generic name for the final Image processing system product Common name for 1: Control board protection coating for image processing system application parts 2: Tube for wire protection of image processing system (2,3) 3: Coating for surface plate protection of image processing system (4) 4: Coating to ensure optical system functions of image processing system (5,8,9,10) 5: Packing to ensure the airtightness and water resistance of the image processing system (6,9) 6: Porous PTFE membrane to prevent condensation in image processing system (7) 7: Thermal radiation sheets for image processing system (11) Detailed application 1: Coating for maintaining the environmental resistance of the image processing system description substrate. Substrate protective coating to protect against special environments (water droplets, foreign matter, gas). Cited from: https://www.arbrown.com/products/humiseal/ 2: Tube for wire protection of image processing system -Shrink tubing for internal fan cable protection 46 -Insulation and protection of various electric wires and parts, waterproof/drip-proof/anticorrosion, and mechanical protection. Cited from: https://ja.nc-net.or.jp/company/92714/product/detail/99785/ 3: Coating to maintain the optical environmental resistance of image processing system A coating that has water and oil repellency properties and allows fingerprints, sweat, sebum, and other stains to be easily wiped off. Increases contact angle and retains water and oil repellency. optical plates* *A resin material that protects the inside of the sensor and transmits light. Cited from: Water repellency/stain resistance (tokaioptical.com) 4: AR coating for smart image sensors Coating to reduce light reflection and increase transmittance No coating Single layer coating Multilayer coating ca. 4% ca. 4% ca. 1.5% ca. 1.5% ca. 0.2% ca. 0.2% Transmittance=ca.92% Trans.=ca.97% Trans.=ca.9.6% Reflectance=ca. 8% Reflectance=ca. 3% Reflectance=ca.0.4% Cited from: https://coating.nidek.co.jp/article/information/type/a37 (nidek.co.jp) 47 -Half Mirror with water and dirt repellent coating (Transmittance 50%, Reflectance 50%) This coating has water and oil repellent properties and can easily wipe off fingerprints, sweat, sebum, and other contaminants. It has a high contact angle and possesses water and oil repellency. Appearance Cross-sectional drawing -Coating that suppresses reflection on the surface of bandpass filters and infrared cut filters used in 3D vision sensors, cameras, etc. Light Anti-reflection mechanism Surface reflection Two saves cancel each other out /Coating /Board Back reflection Reflection of refracted 5: Packing to ensure the airtightness and water resistance of the image processing system -Packing for waterproof IP67 security of smart image sensor Packing of Rear Packing of Hood lighting Packing of Hood Cover 48 -Packing to ensure the waterproof specification (IP67) of the 3D vision sensor 6: Porous PTFE membrane to prevent condensation in image processing system It has a porous membrane and achieves both "waterproof/dustproof" and "breathability/moisture permeability". Cited from: https://www.nitto.com/jp/ja/products/temish_search/about/ SEM Photo Prevent rain, water and dust from entering Water vapor passes through Temish micropores 7: Thermal radiation sheets for image processing system A resin sheet with thermal conductivity. By encapsulating a highly thermally conductive filler in a flexible resin sheet whose main ingredient is acrylic or silicon resin, the resin sheet, which originally does not have thermal conductivity, is given thermal conductivity. By installing it in close contact with the heat-generating parts mounted on electronic equipment, etc., it absorbs heat efficiently and dissipates heat away from the heatgenerating parts, thereby preventing malfunctions and failures of the equipment. Appearance Technical Description of Essential Uses 1: A coating that protects equipment from water droplets, foreign matter, gas, and dirt in the usage environment and ensures functionality cannot maintain alternative characteristics. 2: Equivalent insulation and protection, waterproof/drip-proof, corrosion-resistant, and mechanical protection equivalent to the current performance are required. 49 3: Since lighting equipment such as FL lighting is installed near the workpiece, it is necessary to ensure the lighting characteristics with an anti-fouling coating, and alternative characteristics cannot be maintained. Fluorine-based resin is often the main component in general antifouling coatings. It is possible to change to a product that does not contain PFAS as long as it does not affect the function/performance. 4: Window plates, optical lenses, liquid lenses, and IR cut filter coatings for maintaining environmental resistance cannot maintain alternative characteristics. The main ingredients are inorganic compounds such as MgF2 and SO2, but it is unknown whether they contain PFAS. If it does not affect the optical properties (transmittance, reflectance, wavelength components, etc.), it is possible to change to materials that do not contain PFAS. 5: Since the optical system of the image processing apparatus is installed near the object to be inspected, it is necessary to use highly airtight and water-resistant packing to maintain its function. The main component is rubber. 6: Fluororesin porous membrane. It combines the durability of fluororesin with the breathability of a microporous membrane structure. Fluororesin porous membrane. It combines the durability of fluororesin with the breathability of a microporous membrane structure. The PTFE porous membrane has hundreds of millions of micropores per 1cm2 and exhibits both waterproof and dustproof properties and high breathability at the same time. PTFE resin has excellent properties such as heat resistance, chemical resistance, and non-dusting properties, making it difficult to maintain alternative properties. Heat-resistant Light fastness/ Weather fastness Flame resistance Effect on reflectance/transmittance Substitution 7: In order to maintain the processing performance of the image processing system, a high heat dissipation capability is required, and alternative characteristics cannot be maintained. 2: 125 degree Celsius (Equal to or better than the current situation.) 4: 200 / 200 degree Celsius 4: No functional deterioration in the range from UV light to infrared light (300nm to 2000nm) 2: Flame resistance VW-1 or higher 4: Effect on reflectance/transmittance is within 0.3 Substitution unknown 50 27. Coding for sliding rubber parts of industrial controllers Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Coding for sliding rubber parts of industrial controllers / B2402 Classification of NECA CAS RN Regulated candidate substance name 9002-84-0 Polymeric PFAS / PTFE Generic name for the Industrial controller final product Common name for Packing application parts Detailed application A PTFE-coated lubricant is applied to the outer circumference of the packing to make it description easier to separate the front bezel from the case. Since the housing is made of resin, there is a risk of solvent cracking, and grease cannot be used. Fig.1 Overall product Fig.2 Packing installation explanatory diagram Technical Description of Essential Uses Coating durability Sliding performance Chemical stability The film does not peel off when applied to rubber parts. (Good adhesion) Good lubricity and no effect on plastics. (No solvent cracks occur) Coatings on rubber parts do not degrade over time Sliding performance for mounting and dismounting No impact on plastic cases due to chemical stability (no volatiles or leachables) 51 28. Temperature sensor Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Electronics and semiconductors (Annex E.2.11.) etc. Temperature sensor / B2499 Unidentified 1. Conductor coating / FEP 2. Protective tube / FEP 3. FEP tube /FEP 4. Coating /FEP, PFA Temperature sensor 1. Conductor coating 2. Protective tube 3. FEP tube 4. Coating 1. Used in the coating for the thermocouple wires 2. Protection of the swage part 3. Protection of the sheath 4. Used in the fluorine coating for protective tube and sheath Technical Description of Essential Uses 1. Conductor coating It is used to ensure heat resistance, moisture resistance and chemical resistance; however, there is no substitutable parts. 2. Protective tube It is used to ensure heat resistance, moisture resistance and chemical resistance; however, there is no substitutable parts. 3. FEP tube It is used to ensure heat resistance, moisture resistance and chemical resistance; however, there is no substitutable parts. 4. Coating It is used to ensure heat resistance, moisture resistance and chemical resistance; however, there is no substitutable parts. 52 29. Humidity sensor Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Electronics and semiconductors (Annex E.2.11.) Construction products (E.2.13.) etc. Humidity sensor / B2499 Unidentified Polymeric PFAS / Fluorinated polyimide Humidity sensor, Dew point temperature sensor Humidity element The humidity sensor chip used for a humidity sensor and a dew point temperature sensor measures humidity by capacitance change between electrodes sandwiching the moisture sensitive film. The thickness of the moisture sensitive film is several m. Schematic diagram of sensor chip structure Polymer moisture-sensitive membrane is made of fluorinated polyimide Technical Description of Essential Uses This humidity sensor is used for the following purposes Humidity sensor installed in an environment in which condensation appears on the sensor itself, such as inside the HVAC duct and the outside air intake section. The following features can be obtained by using fluoride polyimide for humidity sensor The humidity sensor works stably for a long period in an environment where the sensor is condensed (100% humidity). Nothing to replace this function. The humidity sensor has higher stability under high temperature, high humidity and organic solvent atmosphere than other products due to the humidity sensitive membrane using fluorinated polyimide. The prohibition of this technology is concerned about the following effects. 53  It won't be able to properly measure and control humidity on HVAC system in an environment in which condensation appears on the sensor itself. Other polymer materials such as methyl methacrylate resin (PMMA), polyimide, polysulfone, etc. can be candidates as alternative technologies and materials. Alternative technology requires replacement of the sensor every time condensation occurs. For example, it is known that condensation appears on a humidity sensor which is inserted into an outside air intake duct several times a year depending on the weather. Humidity sensors without moisture sensitive membrane using fluorinated polyimide for this application will require replacement at least once a year. Moisture sensitive membranes using fluorinated polyimide can withstand at least 8 years of use. Heat-resistant Light fastness/ Weather fastness Water-repellent Required derogation period Socio-economic impact For the reasons mentioned above, the ban on fluorinated polyimide in humidity sensors should be exempted indefinitely because of the economic burden of increased replacement frequency. From the point of view of disposal, the use of fluorinated polyimide in the humidity sensor should not be restricted as it generally leads to waste reduction. 180C as a humidity sensitive film Weather fastness: 100%RH Electrical insulation in condensing environments 13.5 years or more Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 54 30. Safety controller Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Safety controller / B2601 69991-67-9, 60164-51-4, 1623-05-8, 25038-02-2 and more PFPE [Perfluoropolyether] Same as above application Card Contact Safety relay unit Safety relay <Internal structure> Card - Sliding points Contact It is used to reduce frictional resistance on the sliding part (card) of the safety controller built into the safety relay unit to achieve high mechanical durability and reliability. And it is used in coatings to protect contacts from dirt, reduce frictional resistance, and maintain high reliability. Technical Description of Essential Uses The technically difficult points of substitution are as follows. Fluorinated lubricants are commonly used in several relays because they can be easily diluted with similar fluorinated solvents and can be applied evenly and easily dried. Because relay has contacts structure, contact reliability is reduced due to abrasion powder generated when plastic or metal parts mechanically operate. Decrease in stability of relay operation due to increased friction of sliding parts. 55 Low friction/wear resistant When parts slide, there is no generation of abrasion powder that causes poor contact of contacts. 56 31. Switching power supply / Transformer Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application Switching power supply / Transformer CAS RN 9002-84-0, 26655-00-5, 25038-71-5 Regulated candidate PTFE [Polymer of 1,1,2,2-tetrafluoroethene] substance name PFA [Tetrafluoroethylene-co-perfluoro (Alkyl vinyl ether)] ETFE [Polyethene-co-tetrafluoroethene] Generic name for the final product Same as above application Common name for Insulation Wire application parts Non-heat shrinkable Tube Detailed application 1. Used for the cable of Switching power supply/ Transformer description 2. Used for tube of Seal parts << Schematic Cross-sectional View >> Cable Tube 1. Insulated wires ETFE or PFA insulated wires are used for transformers installed in power supply equipment, and the main component is ETFE or PFA. ETFE and PFA resin have a low dielectric constant and a high heat resistance of 200C, so the wire coating can be made thinner. It is essential for miniaturization and weight reduction of equipment. 2. Non heat shrink tubing The transformer installed in the power supply equipment uses non-heat shrinkable polytetrafluoroethylene (PTFE) tube, and the main component is PTFE. Even though the PTFE tube is thin, it has high insulation performance and heat resistance. There is no alternative material that can be used in applications where there is not enough space for insulation and meets the requirements in tight spaces. 57 32. Measuring pipe lining material for industrial electromagnetic flowmeters Essential Application Main use sector Energy sector (Annex E.2.12.) Petroleum and mining (Annex E.2.15.) etc. Application/ Measuring pipe lining material for industrial electromagnetic flowmeters / C1699 Classification of NECA CAS RN ETFE : 25038-71-5 PFA : 26655-00-5 Regulated candidate Polymeric PFAS / substance name ETFE, PFA Generic name for the Industrial electromagnetic flow meter final product Common name for Measuring pipe application parts Detailed application description Connection flange Measuring pipe Lining Technical Description of Essential Uses Industrial electromagnetic flowmeters are inserted into pipes that require measurement and are used as part of large-scale equipment such as industrial chemical plants. Industrial electromagnetic flowmeters measure corrosive fluids such as chemicals as an application. The measurement of corrosive fluids such as chemicals is 30% of the applications of industrial electromagnetic flowmeters. Industrial electromagnetic flowmeter is required to have performance that can withstand the measurement of corrosive fluid. In order to measure corrosive fluids with industrial electromagnetic flowmeters, PFA and ETFE measurement pipe linings are required in the flow path where the corrosive fluids come into contact. Other polymeric materials, such as rubber and resin, may be used as substitutes for the lining of measuring pipes with PFA and ETFE. However, the alternative materials have poor resistance to various chemicals in industrial chemical plants 58 and cannot withstand corrosive fluids. In alternative technologies and materials, it is necessary to replace the industrial electromagnetic flowmeter itself because the electromagnetic flowmeter itself connected to the pipe is stopped and the corrosion status is periodically checked, and when corrosion occurs, the flow measurement cannot be performed. Electromagnetic flowmeters using ETFE and PFA measuring pipe linings can operate stably for at least 10 years without confirmation. There are concerns about the following impacts due to the unavailability of this technology Production efficiency in production plants for corrosive fluids such as chemicals will drop significantly due to the inability to use lining materials for measuring pipes using PFA and ETFE for industrial electromagnetic flowmeters. This affects the production and supply of chemical products. For the above reasons, the prohibition of lining of measuring pipes by PFA and ETFE in industrial electromagnetic flowmeters should be exempted indefinitely from this restriction due to the economic burden caused by the increase in the frequency of periodic checks and replacements due to equipment shutdowns. Heat-resistant Chemical resistance Wear resistance No-adhesion Required derogation period Socio-economic impact From the viewpoint of disposal, restrictions should not be applied because the use of PFA and ETFE lining of measuring pipes in industrial electromagnetic flowmeters allows the electromagnetic flowmeter to be used until it reaches its original service life, which generally leads to a reduction in waste. Must withstand fluids up to 160C No corrosion from corrosive fluids Less wear from abrasive slurry fluids Less sticking with sticky slurry fluids 13.5 years or more Note: This application should have the same derogation period as petroleum and mining. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 59 33. Fill Fluid for chlorine or oxygen pressure measurement Essential Application Main use sector Energy sector (Annex E.2.12.) Petroleum and mining (Annex E.2.15.) etc. Application/ Fill Fluid for chlorine or oxygen pressure measurement / C1699 Classification of NECA Application CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Fill Fluid for chlorine or oxygen pressure measurement 79-38-9/9002-83-9/113114-19-5 PFAS-based lubricant oil / PCTFE / Perfluoropolytrimethyleneoxide Industrial Pressure Transmitter Fill Fluid for chlorine or oxygen pressure measurement Pressure Transmitter 1) Measuring Principal A pressure transmitter consists of a barrier diaphragm that contacts the process pressure, a center diaphragm that protects the sensor, and a sensor that detects the pressure. If there is a difference in pressure on each barrier diaphragm, the fill fluid that carries the pressure creates a pressure difference on either side of the sensor, which distorts the sensor and changes its resistance. Measure the pressure by converting the resistance change of the sensor. Standard type Remote type Barrier High Pressure Sensor Pressure Low Pressure Center Yellow and orange area mean fill fluid Technical Description of Essential Uses In addition to the following items, the properties required for the fill fluid include fluidity even at low temperatures, low viscosity, and nonflammability. The only fill fluid that offers all of these is the fluorinated fill fluid, and there is no alternative. In addition to the following items, the properties required for the fill fluid include fluidity even at low temperatures, low viscosity, and nonflammability. The only fill fluid that offers 60 Heat-resistant chemical resistance chemical stability electrical insulation Required derogation period Socio-economic impact all of these is the fluorinated fill fluid, and there is no alternative. The diaphragms that come into contact with process fluids may be damaged due to corrosion or abrasion during use. When broken, the fill fluid comes into direct contact with the process fluid, but otherwise does not leak into the environment. This product is a WEEE target model and is in a controlled state for disposal. Silicon oil is the most likely alternative, but it reacts with chlorine and oxygen at high temperatures and pressures and explodes in the worst case. Sealed liquid is required to have heat resistance. Stable against strong corrosive acids and alkalis. Does not react with chlorine and oxygen even under high temperature and pressure. Since the fill fluid is in direct contact with the sensor, high electrical insulation performance is required. 13.5 years or more Note: This application should have the same derogation period as petroleum and mining. Problem with the safety of the worker. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 61 34. Mass Flow Controller seal Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Mass Flow Controller seal / C1699 Classification of NECA CAS RN Unidentified Regulated candidate Fluorine rubber / substance name FKM Generic name for the Mass Flow Controller final product Mass Flow Meter Piping joints used for measurement and control equipment Common name for O-ring application parts Detailed application O-rings are used as sealing parts to prevent external leakage at joints between different parts. description <Mass flow controller usage example> cross section Example of use in joints between fitting Example of use for joints between flange parts and body parts Technical Description of Essential Uses FKM is used for various gases with excellent heat resistance, chemical resistance, ozone resistance, etc., especially when using flammable oxygen gas, it is used due to its high heat resistance and ozone resistance, and the alternative product is a special rubber material, but it becomes a fluorine-based rubber material and the use of fluorine-based substances is unavoidable. Heat-resistant Chemical resistance Ozone resistance Required derogation period Socio-economic impact If fluorine-based materials are not used, safety is significantly impaired. The flexibility of rubber does not change from -10C to +60C Chemical resistance to withstand components contained in combustible gases Resistant to ozone gas 13.5 years or more Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 62 35. Mass Flow Controller lubricant oil Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Mass Flow Controller lubricant oil / C1699 Classification of NECA CAS RN Regulated candidate substance name Unidentified PFAS-based lubricant oil / PFPE (Perfluoropolyether) Generic name for the Mass Flow Controller final product Mass Flow Meter Piping joints used for measurement and control equipment Common name for lubricant application parts Detailed application Mass flow controllers and mass flow meters are used for flow control and flow measurement of description various industrial gases. Lubricating oil is applied to joint screws and O-rings to prevent screw galling and improve the assembly of O-rings. screw Technical Description of Essential Uses Chemical stability Required derogation period Socio-economic impact Ordinary grease and oil cannot be used because they may become a source of ignition when flammable oxygen gas is used, so their safety is significantly impaired. Chemical stability that does not react to combustion-supporting gases such as oxygen 13.5 years or more Problem with the safety of the worker. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 63 36. Control valve of mass flow controller Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Control valve of mass flow controller / C1699 Classification of NECA CAS RN 9002-84-0 Regulated candidate Polymeric PFAS / substance name PTFE Generic name for the Mass Flow Controller final product Common name for Control valve application parts Detailed application Mass flow controllers are used for flow control of various industrial gases. description PTFE is used as the material of the valve body of the flow control valve of mass flow controller. See part (10) in the figure below (the right is a partial enlarged view). Cross-sectional view of the product Cross-sectional view of the valve Enlarged view 64 Technical Description of Essential Uses Heat-resistant Chemical resistance Ozone resistance Required derogation period Socio-economic impact PTFE has high corrosion resistance and heat resistance. As an alternative, rubber materials will be used, but it will be fluorine-based rubber materials and the use of fluorine-based substances is unavoidable. Heat resistant to withstand operation from -10C to +60C Chemical resistance to withstand components contained in combustible gases Resistant to ozone gas 13.5 years or more Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 65 37. Fittings for micro-flow rate liquid flow meter for semiconductor manufacturing process Essential Application Main use sector Electronics and semiconductors (Annex E.2.11.) etc. Application/ Fittings for micro-flow rate liquid flow meter for semiconductor manufacturing process / Classification of NECA C1699 Application CAS RN Fittings for micro-flow rate liquid flow meter for semiconductor manufacturing process 26655-00-5 9002-84-0 Regulated candidate Polymeric PFAS / substance name PFA, PTFE Generic name for the Micro flow rate liquid flow meter final product Common name for Fitting application parts Detailed application description Micro flow liquid flow meters are used to measure micro flow rates of fluids used in semiconductor manufacturing processes. If impurities are mixed in the fluid used in the semiconductor manufacturing process, it will adversely affect the yield of semiconductor production. The liquid flow path inside the micro flow rate liquid flowmeter is composed of a quartz glass tube that does not elute into the fluid. Fluororesin is used for the fitting of the micro flow rate liquid flow meter. Micro flow rate liquid flow meter Fluororesin fitting Flow path Fitting Technical Description of Essential Uses Semiconductor manufacturing process is required high level chemical controls, due to chemical contamination makes negative influences on quality of products. PTFE and PFA which are inert to various chemicals and also include low additives, are suitable materials for flow paths in semiconductor manufacturing process. Impact of prohibition using PFA, PTFE It will be impossible to keep miniaturization technology used in current semiconductor manufacturing process. 66 Chemical resistance Cleanliness performance Required derogation period Socio-economic impact To avoid this problem would require a great deal of effort and technical innovation. Resistant to chemicals and solvents fluids Cleanliness performance without elution and volatilization of components from components 13.5 years or more Note: This application should have the same derogation period as semiconductor manufacturing processes. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. Yield deterioration in the semiconductor manufacturing process 67 38. Control valve seat ring Essential Application Main use sector Energy sector (Annex E.2.12.) Petroleum and mining (Annex E.2.15.) etc. Application/ Control valve seat ring / C1699 Classification of NECA CAS RN 9002-84-0 Regulated candidate Polymeric PFAS / substance name PTFE Generic name for the Control valve final product Common name for Seat ring application parts Detailed application Control valves are used in a variety of different markets that controls fluid flows in plumbing description installed in air conditioning system of building, and Industrial plants, for example petrochemical and power plant. Seat ring is a component of control valves that has a function of stopping the flow by contacting with the plug when it is fully closed. fig1. Control Valve for rotary motion Plug up and down motion Valve Seat Seat Ring Technical Description of Essential Uses fig2. Control Valve for HVAC ball In case of the control valve in fig1, the tight contact load with the PTFE seat ring is generally lower than the contact load with metal seat ring. In case of the control valve fig2, the ball rotates to control flow while sliding with the seat ring. By using the PTFE for the seat ring, it makes possible to reduce operation torque of ball because of low friction. Hence it is enough to operate control valves with PTFE seat ring by downsized actuator. As the results, the downsizing of actuators contributes to reduce usage of metal materials and consumption of energy for the valve operation. 68 In general, the friction coefficient of PTFE (0.1 or less) is approximately 1/5 that of metal (approximately 0.5), and the torque required to rotate the plug is approximately 1/5 in proportion to the friction coefficient. Add that, corrosive and high temperature fluid flows through control valves. So, excellent chemical and heat resistance are required to control valves. PTFE fills all of characteristics aforementioned. Furthermore, it has proven track record of long-term use in various fields. It is extremely difficult to use alternate materials simultaneously satisfy the requirements of heat resistance, chemical resistance, sliding performance and seal performance. Heat-resistant chemical resistance Sliding performance Seal performance Required derogation period Socio-economic impact Hence it is hard to replace PTFE. Heat resistance that can withstand high temperatures of 230C Resistant to water control chemicals and steam containing chemicals Wear resistance due to sliding, sliding performance. High sealing performance with low clamping force 13.5 years or more Note: This application should have the same derogation period as petroleum and mining. Upsizing of equipment. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 69 39. Material for scraper rings in industrial control valves Essential Application Main use sector Energy sector (Annex E.2.12.) Petroleum and mining (Annex E.2.15.) etc. Application/ Material for scraper rings in industrial control valves / C1699 Classification of NECA CAS RN Regulated candidate substance name 9002-84-0 Polymeric PFAS / PTFE Generic name for the Industrial Control valve final product Common name for VALVE SCRAPER RING application parts Detailed application description Stem Bonnet Gasket Scraper Ring Upper Cage Valve Seat Plug Lower Cage Seat Gasket Technical Description of Essential Uses Industrial control valves are installed in pipes of various industrial plants, that are used to control flow of fluids. Scraper Rings can scrape fluid attached on a cage of the control valve. Scraper Rings have functions to prevent plug-cage sticking. Industrial control valves control corrosive fluids such as chemicals depend on facilities, therefore they must be able to use for the corrosive fluids. However, it is difficult to identify some corrosive fluid because we can hardly grasp intermediate substances produced by chemical reactions in the chemical production process. Therefore, it is necessary that the control valves have wide range of chemical resistance. PTFE scraper rings are indispensable parts contacted with corrosive fluid for control flow of the fluid. Other polymer materials, such as rubber and resin, might be able to substitute for PTFE as the material of scraper rings. However, it is considered that the alternative materials are not suitable, because they do not have enough resistance to various chemicals of chemical plants. If PTFE substitutes for the alternative material, the control valves and other facilities are regularly stopped to maintain to check corrosive status. Then if corroded parts are found, they should exchange new parts. 70 If use of PTFE scraper ring is prohibited, following influence is concerned. - Productivity of the plants manufacturing the corrosive fluid such as chemicals will decrease markedly, thereby influencing production of chemical products. - Prohibition of PTFE scraper ring will cause increase of maintenance number, thereby increasing economic load and industrial waste from the maintenances. Heat-resistant chemical resistance Wear resistance No-adhesion Required derogation period Socio-economic impact For above reasons, Prohibition of PTFE scraper ring should be exempt from this restriction indefinitely. Heat resistance that can withstand high-temperature fluids of 230C Corrosion resistance with corrosive fluids Less wear from abrasive slurry fluids Less sticking with sticky slurry fluids 13.5 years or more Note: This application should have the same derogation period as petroleum and mining. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 71 40. Lining and throttling mechanism materials for industrial control valves Essential Application Main use sector Energy sector (Annex E.2.12.) Petroleum and mining (Annex E.2.15.) etc. Application/ Classification of NECA Lining and throttling mechanism materials for industrial control valves / C1699 CAS RN 25038-71-5 26655-00-5 Regulated candidate substance name 9002-84-0 Polymeric PFAS / ETFE, PFA, PTFE Generic name for the final product Industrial Control valve Common name for application parts VALVE BODY Detailed application description Industrial control valves are installed in pipes of various industrial plants, that are used to control flow of fluids. Industrial control valves are used to control corrosive fluids such as chemicals. Aperture mechanism valve linings Technical Description of Essential Uses Industrial control valves are required to be able to withstand the control of corrosive fluids at high temperatures. In order to control corrosive fluids with industrial control valves, main body linings and throttle mechanisms made of PFA, ETFE and PTFE are required in the flow passages where corrosive fluids come into contact. It is possible that other polymer materials such as rubber and resin can be used as alternative materials for body lining and throttle mechanism using PFA, ETFE, and PTFE. However, alternative materials have poor resistance to a wide variety of chemicals in industrial chemical plants and cannot withstand corrosive fluids. If it is assumed that metal materials such as chromium and nickel alloys will be substituted, it is necessary to periodically stop the equipment and check the corrosion status of the control valves connected to the pipes. When corrosion occurs, fluid control becomes impossible, so it is necessary to replace the industrial control valve itself. 72 The use of PFA, ETFE, and PTFE as lining and throttling mechanism materials for industrial control valves may cause the following concerns: The production efficiency in plants handling corrosive fluids, such as chemicals, may significantly decrease, thereby impacting the production and supply of chemical products. For above reasons, Prohibition of PTFE scraper ring should be exempt from this restriction indefinitely. Heat-resistant chemical resistance Wear resistance No-adhesion Required derogation period Socio-economic impact In terms of disposal, the restriction should not be applied to valves containing PFA, ETFE, and PTFE since these components can be used until the product reaches its original service life, leading to a reduction of waste in general. Heat resistance that can withstand high-temperature fluids of 140C Corrosion resistance with corrosive fluids Less wear from abrasive slurry fluids Less sticking with sticky slurry fluids 13.5 years or more Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 73 41. Valve for air volume and room pressure control Essential Application Main use sector Medical devices (Annex E.2.9.) Construction products (Annex E.2.13.) etc. Application/ Classification of NECA Materials for ensuring slidability, corrosion resistance, chemical resistance, and solvent resistance for airflow valves / C1699 CAS RN 26655-00-5 Regulated candidate substance name 9002-84-0 24937-79-9 25038-71-5 Polymeric PFAS / PFA, PTFE, PVDF, ETFE Generic name for the final product Valve for air volume and room pressure control Common name for application parts Detailed application description Body, Pivot arm, S-link, Shaft, Spring, Cone, Brackets, Seal, Tap, e-crip, Bush, Slider, Sleeve, Cap, Bolt The two main applications of valves are below. (1) To be installed as a local exhaust ventilation system to prevent workers from being exposed to substances harmful to the human body, such as in chemical manufacturers and biotechnology research laboratories. For example, when a worker opens or closes the door of the local exhaust device (red dotted frame in Fig.1), the differential pressure across the valve suddenly changes, but by taking advantage of the good sliding property, the valve can be instantly changed to the appropriate valve opening position to maintain exhaust at a constant air volume. In addition, since valves must control fluids containing various chemicals and solvents, they must be resistant to corrosion, chemicals, and solvents. Flexible hood Arm hood Chemical storage bottle cabinet Ventilated sink Sink hood Fig.1 Example of air volume control in a chemical Fig.2 Other exhaust applications (2) The device is installed in hospital rooms and wards as a negative-positive pressure control device to secure hospital beds for patients with infectious diseases and to protect healthcare workers from infection risk. Even when the differential pressure across the valve suddenly changes due to the opening and closing of the hospital room entrance door, etc., the air supply and exhaust valves respond instantly by taking advantage of their good sliding characteristics and change to the appropriate opening position, thereby always maintaining the pressure difference between the room and outside. 74 Fig.3 Image of negative and positive pressure control in a hospital room The parts used in valves that include candidates for regulation are below. SealTap Bush Fig.4 Valve image Slider Bolt E-crip Sleeve Cap Fig.5 Slider assembly (1) For valves that do not require corrosion resistance, chemical resistance, or solvent resistance, parts (Slider, Sleeve, Cap) containing PTFE should be used to ensure sliding properties. (2) Valves that require corrosion resistance, chemical resistance, and solvent resistance use the following parts to ensure the above three functions and sliding properties. Parts containing PTFE (Slider, Sleeve, Cap, Bush, Seal, Tap) Parts containing PFA (Shaft, Spring) Parts containing PVDF or ETFE (Body, Pivot arm, S-link, Cone, E-crip, Bolt) 75 Technical Description of Essential Uses Heat-resistant chemical resistance Sliding performance No-adhesion Required derogation period Socio-economic impact As mentioned above in ``Detailed application description'', valves must have the sliding property required to respond instantly to sudden disturbances, and the corrosion, chemical, and solvent resistance required to control fluids containing various chemicals and solvents. Therefore, it is necessary to place parts containing PTFE, PFA, PVDF, and ETFE for mechanisms that need to ensure sliding properties and for channel parts that are in contact with the control fluid. (1) Ensure sliding properties Other polymeric materials may be used as an alternative to PTFE for ensuring sliding properties. However, since there is no material with lower sliding resistance than PTFE, the sliding resistance force will increase and the sliding performance required for valves cannot be ensured. (2) Ensure sliding properties, corrosion resistance, chemical resistance, and solvent resistance Other polymeric materials, such as rubber and resin, may be used as alternatives to PFA, PTFE, PVDF, and ETFE for the purpose of ensuring the above four functions. However, the alternative materials cannot ensure the sliding properties, corrosion resistance, chemical resistance, and solvent resistance required for valves due to the deterioration of sliding properties as described in (1) and the lack of resistance to various chemicals and solvents. The following effects are feared as a result of the unavailability of these technologies. The inability to use PFA, PTFE, PVDF, and ETFE for valves will make it impossible to carry out normal operations at chemical manufacturers, biotechnology research facilities, hospitals, and other facilities. This will have a profound impact on the production and supply of medicines, the progress of research in biotechnology, and isolated medical treatment, including coronas. For the above reasons, the prohibition of the use of parts containing PFA, PTFE, PVDF, and ETFE in valves should be exempted from this restriction in terms of ensuring safety for the human body. In terms of disposal, the restriction should not be applied to valves containing PFA, PTFE, PVDF, and ETFE, since these components can be used until the product reaches its original service life, leading to a reduction of waste in general. Heat-resistant max 93C Resistant to chemicals, solvents and corrosive fluids Wear resistance due to sliding, sliding performance No-adhesion of foreign matter 13.5 years or more Problem with the supplying specific pharmaceuticals. Problem with the safety of the biohazard test. Problem with the safety of pandemic countermeasures. Shorter operational lifetime. Increased frequency and costs of maintenance. Increased operational downtimes. 76 42. RFID tag and antenna Essential Application Main use sector Metal plating and manufacture of metal products (Annex E.2.4.) Electronics and semiconductors (Annex E.2.11.) etc. Application/ RFID tag and antenna / C1699 Classification of NECA CAS RN 2655-00-5, 31784-04-0 Regulated candidate PFA (perfluoroalkoxy alkane) substance name Generic name for the RFID tag and antenna final product Common name for Cover application parts Detailed application description White part is resin cover Technical Description of Essential Uses For chemical and spatter resistance, fluoroplastic-coated covers are attached to the tags and antennas. These RFID tags and antennas are specially designed for use in environments where chemicals are used or spatter flies from welding, etc. They are difficult to replace in order to maintain durability. 77 43. Ionizer Essential Application Main use sector Application/ Classification of NECA CAS RN Regulated candidate substance name Generic name for the final product Common name for application parts Detailed application description Electronics and semiconductors (Annex E.2.11.) etc. Ionizer / C1699 Unidentified Teflon Ionizer Air tube A tube to send ionized air to the nozzle Technical Description of Essential Uses Since electrical discharge causes increased concentration of ozone, an ozone-resistant air tube is required. 78