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Ref. Ares(2024)2544971 - 08/04/2024 PFAS and EEE Specialist equipment Participants: (JBCE (JBCE (JBCE (JEMIMA) (JAIMA) ) ) ) 23rd June 2023 Agenda Introduction of associations Characteristics of spcialist equipment PFAS in spcialist equipment Introduction of the associations 3 Who is JBCE Created in 1999, JBCE (Japan Business Council in Europe) is a leading European organisation representing the interests of 100 multinational companies of Japanese parentage active in Europe. We work closely with the EU Institutions to strengthen both the political and trade relationship between the EU and Japan and to develop a policy framework that supports fruitful and responsible business conduct. We work closely with the EU Institutions to strengthen both the political and trade relationship between the EU and Japan and to develop a policy framework that supports fruitful and responsible business conduct. Building a new era of cooperation between the European Union (EU) and Japan is the core of our activities, which we perform under several committees focusing on: Corporate Policy, Corporate Social Responsibility, Digital Innovation, Environment & Energy, Standards and Conformity, and Trade. Mission of JBCE Build a bridge between Japan and the EU, enhancing Europe's understanding of Japanese companies and their contribution to the European economy Contribute to EU public policy by sharing our members' expertise with decisionmakers across sectors Promote a favorable and predictable environment in which Japanese companies of all sectors can compete for sustainable growth in Europe Introduction of Coalition of Cat.8&9 JAIMA (The Japan Analytical Instruments Manufacturers' Association) JEMIMA (Japan Electric Measuring Instruments Manufacturers' Association) JFMDA (The Japan Federation of Medical Devices Associations) JIMA (Japan Inspection Instruments Manufacturers' Association) JMIF (Japan Measuring Instruments Federation) NECA (NIPPON ELECTRIC CONTROL EQUIPMENT INDUSTRIES ASSOCIATION) SEAJ (Semiconductor Equipment Association of Japan) JEMA (The Japan Electrical Manufacturers' Association) JMC (Japan Machinery Center for Trade and Investment) JEITA(Japan Electronics & Information Technology Industries Association) 7 JEMIMA Japan Electric Measuring Instruments Manufacturers'Association https://www.jemima.or.jp/ An association of manufacturers of electric measuring instruments Established in 1948 Regular members 80 companies Supporting members 27 companies, 13 organisations JEMIMA explanation https://www.jemima.or.jp/about/pamphlet.html 8 Categories and Products of Electric Measuring Instruments Electric measuring instruments measure quantities and sizes of substances and phenomena,, and are grouped into following 8 categories. 9 Overview of JAIMA Name Japan Analytical Instruments Manufacturers' Association (JAIMA) Representative Established YearAugust 18, 1960 (June 2023~) Regular Members98 Companies Manufacturers of analytical instruments Associate Members66 Companies Traders and distributers of analytical instruments JAIMA product range Laboratory instruments (GC, LC, MS, IR, IC, Thermal, UV, XRF, XRD, SEM,TEM, NMR, PSA, pH...) Environmental analyzers (Air and water pollution monitoring) Process analyzers Clinical test instruments and systems (Clinical chemistry, immunology and Hematology) Biotechnology Characteristics of specialist equipment 12 What is specialist equipment ? Contributing to safety of the society, human health, and the environment 13 Specialist equipment is often safety critical Defibrillators -> Death likely if not functioning Balance to measure medicine -> wrong dose can be fatal for patients. X-ray apparatus -> wrong dose can harm patient / must be accurate. Pollutant monitoring -> impact environment and human health Smoke detectors -> minimize damage caused by fire Product lifetime is long Consumer Products (ex. Mobile Phone) Specialist equipment (ex. Total Organic Carbon Analyser ) Lifetime: 4 to 5 years Replace with new one in 2 - 5 years up to 20 -25 years 7 to 10 years Spare parts are important Repairs are necessary to prolong the lifetime of Electrical and Electric Equipment Original spare parts are needed to ensure the original performance (i.e. safety and durability) This aligns with "Right to repair" and "Repair as produced" RoHS Directive 4.4* allows the use of spare parts for the repair If spare parts are not derogated Repairable EEE and stocked spare parts become waste Long-life EEE cannot fulfill expected lifetime (ex. 20 years) * EURLex 02011L006520160715 EN EURLex (europa.eu) Different Product Diversity characteristics Number of sales/year Consumer Products (ex. Mobile phone) 257 million** Specialist equipment (ex. Test equipment) 0.13 million* Number of current ca. 10**** models/ manufacturer 1600*** *source: https://www.statista.com/outlook/15020100/102/mobilephones/europe?currency=eur#marketarpu **source: eurostat, Sold production, exports and imports by PRODCOM list (NACE Rev.2) - annual data, Jan.Dec.2018, 26516200 - Machines and appliances for testing the mechanical properties of materials *** source: ERA Report 20060383 - Final Report **** source: https://en.wikipedia.org/wiki/List of Android smartphones 18 PFAS in specialist equipment 21 PFAS: various properties A material fulfilling several properties is required. Chemical resistance (ex. acid, ozone,...), inertness Pressure resistance Resistant to low/high temperature (>260C) Flame retardant Elasticity Low friction Non-adhesion Electrical insulation Low boiling point Fine difference in properties have a significant impact on the performance of the equipment and measurement results. Lack of analytical methods general lack of analysis methods applicable to the broad range of substances and matrices in which PFAS are used. - Reference materials are not available for all PFAS. - Available standards are limited (ex. PFAS in water, in soil) - No established analysis method is known for PFAS in complex articles such as Electric and Electrical Equipment. -> the enforcement of such a broad PFAS restriction is not feasible Key Messages Specialist equipment are often critical for our society. Adequate derogations are necessary because of lack of altenatives. (extension etc.) Existence of alternative substances does not automatically means that final products can be produced with altenatives. (saftey, reliablibity etc.) Adequate transition period is necessary. (reliability testing etc.) Spare parts: the "repair as produced" principle should be introduced. Lack of analysis methods Thank you