Document ppzG8qpa2JgZbOn1KERE3bDM6

PFAS: The challenge for highly regulated and essential sectors 6 December 2022 Holland House Brussels (& Online) Organized by Programme 9h00 Opening remarks, , FIPRA 9h15 Panel discussion (10min/speaker): 9h55 Panel debate & Q&A session 10h40 Concluding remarks, Jan Ahlskog, FIPRA 10h45 Coffee & Networking session 4.PFAS- A CHALLENGE C'chemsec INTERNATIONAL CHEMICAL SECRETARIAT ChemSec, PFAS , December 2022 WHAT WE DO AT CHEMSEC Drive the political discussion on hazardous chemicals Challenge companies to improve their chemicals management Develop online tools to help companies switch to safer chemicals Inform investors about risks and opportunities in the chemical industry THE URGENCY Scientific reports show the urgent need for change Overstepping the planetary boundaries Business as usual is not an option EU regulations good start but not enough Substitution has not occurred at the expected pace The most harmful chemicals needs to be phased out in all but "essential uses" OPPORTUNITIES WITH ESSENTIAL USE Better protection of human health and the environment Making the regulation more efficient Using public resources for the most important cases Focus on substation for the most harmful chemicals Incentive for innovation and substitution IT'S NOT ABOUT THE IMPORTANCE OF SPECIFIC PRODUCTS - BUT ABOUT WHEN WE CAN ACCEPT VERY HAZARDOUS SUBSTANCES HOW TO DECIDE WHAT IS ESSENTIAL USE AND WHAT IS NOT Necessary for health and safety" and "critical for society. Clarified by: "Severe health issues" and "basic conditions for human life and health". Is the chemical (for example PFAS) essential for the function of the product? Are alterantives available? - 2RP LA , 3 Ea yg BDBy2 Ld Pa<i i[& ade 2 = Rs = LX TS =i : : N DyOR iy NE 0a. f E Rd) =; -- ARy = a +R p " a, A : 2) x : &5 -: E -. Ea 04 : [D> Q. i be od AER TTY TTS Lo =. y " - y =J + N . AN 2 3 THANK YOU FOR LISTENING! - - - -ow --_ ....._ -i - ..- --1 ... LIIii7 ......- -- 3.`-- -' . ,...- ' ' =..= ..... , A_-_ =Illr=. - - .. ..r. a ..--- ... TM, _ NIW --. _ - - .mmr me - PFAS in the Pharmaceutical Industry - FIPRA Discussion 6 Dec 2022 11 Use of PFAS in (Bio)-Pharmaceutical Production Industrial use with control of materials over the full Life Cycle Active Ingredients (API) and Medical Devices are regulated separately Primary packaging is part of the marketing authorization Regulations must be conflict free in overlapping areas 12 The OECD PFAS Definition OECD 2018: -CnF2n-, n 3 or -CnF2nOCmF2m-, n and m 1 OECD 2021: -CF3 or -CF2- OECD 2018 OECD 2021: Why was the scope expanded? The intention of the revision of the PFAS definition is not to expand the PFAS universe, but to comprehensively reflect it ... to have a general PFAS definition that is coherent and consistent across compounds from the chemical structure point of view and is easily implementable for distinguishing between PFASs and non-PFASs, also by non-experts. The term "PFASs" is a broad, general, non-specific term, which does not inform whether a compound is harmful or not, but only communicates that the compounds under this term share the same trait for having a fully fluorinated methyl or methylene carbon moiety." The decision to broaden the definition ... is not connected to decisions on how PFASs should be grouped in regulatory and voluntary actions. [OECD Report] Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical Guidance - PFAS Central 13 PFAS Risk vs Benefit Risk through PFAS Use Substances with intrinsic harmful properties (e.g. persistent and also mobile/toxic, endocrine disrupting or CMR). In API, being a PFAS or not does not determine persistence or bioaccumulative properties Emissions of PFAS in Production, during Use or End of Product Life PFAS Use where Risks are Controlled Products subject to regulations other than REACH such as pharmaceuticals or animal health products, where data is available and safety / environmental risk assessments were conducted Production and manufacturing materials that do not become product components, such as fluoropolymers in industrial use Materials where emissions are properly controlled over the full life cycle, which may include production materials, but also other machinery or aviation equipment 14 Substitution Replacing a chemical with a safer alternative is just one way of looking at substitution More often, basic innovation phases out harmful chemicals or other hazards Restricting substances based on structure, regardless of properties and/or risk, severely impacts R&D in all technology sectors Implosion Risk X-rays Lead Heavy High Voltage Circularity Issues Hg ( LED) PFAS Moisture Sensitive Lifetime Inefficient CRT TFT OLED Image Source: Wikipedia 15 Conclusion: What To Look For in a Simple, Applicable and Efficient Restriction Include Proportional measures addressing the problem ,,emission of harmful substances to the environment" Criteria to identify ,,Harmful PFAS" Derogations for demonstrated low/controlled emissions of PFAS over the full Life Cycle Essential Use derogations on a case-by-case basis as a last resort Exclude Undefined terminology and avoidable complexity, leading to uncertainty in implementation. Unclear requirements create effort in the industry and the authorities without benefit, slowing down substitution and other beneficial developments. REACH aspects overlapping with pharmaceutical regulations, or those of medical devices or veterinary products Impact on EU manufacture of pharmaceutical materials Negative impact on innovation or research 16 European Semiconductor Industry Association PFAS in the semiconductor industry , ESIA ESIA ESIA Members unec embracing a better life Z. Melexis life.augmented BOSCH -2 FONDAZIONE BRUNO KESSLER Fachverband der ELektro- und ELektronikindustrie I fine infel, Ni Fraunhofer MIKROELUMME leti CeDtech GlobalFoundries LFOUf V -=..ee Solutions for great visions icron nexperia Np .-eNES/15 ATDK TEXAS INSTRUMENTS )(fa b ZVEI Die Elektroindustrie The voice of the semiconductor industry in Europe Represent the interests of the European-based semiconductor industry and advocate for its international competitiveness most R&D-intensive sector highly-developed global supply chain fierce competition & price fluctuation short innovation cycles multiplier for growth, electronics boost innovation global market estimated at $ 556 billion in 2021 (+26.2% yoy) Europe strongest market for automotive (29%) EU ca. 10% of global market direct employment 200.000 indirect up to 1.000.000 ESIA is member of the World Semiconductor Council (WSC) PFAS use by the semiconductor industry Constituent of specialty process chemistry formulations (photolithography, chamber cleaning/etching, and other mixtures) Direct criticality > 13 types of distinct uses / material functionalities Semiconductor manufacturing equipment (HTFs) Fluoropolymer articles in manufacturing equipment and chemical distribution systems (filters, tubing, linings, o-rings, etc.) Fluoropolymers in articles (component, wire, cables, printed circuit boards, batteries, insulators, capacitors, etc.) Factory infrastructure `Fabs' Fluoropolymer articles in water purification, chemical delivery and waste management systems (tank and duct linings, pipes, etc.) EU restriction Challenges and impacts PFAS containing specialty formulations are a prerequisite for semiconductor manufacturing in Europe Industry transition from PFOA & PFOS to short-chain PFAS specialty formulations (process chemistries) Industry will remove PFHxA according to regulatory timeline Broad current draft scope of EU restriction Global industry sector with a global supply chain Semiconductors are crucial for countless applications (manufacturing, healthcare, transport, etc.) Context of EU Chips Act Growth expectation Double global market share from 10% today to at least 20% in 2030 Strengthen EU's research and technology leadership on small and fast chips More than 43 billion of policy-driven investment until 2030 Tightening environmental regulations PFAS restriction F-Gas Regulation Questions? Thank you for your attention! http://www.eusemiconductors.eu/ Twitter : @eSemiconductor LinkedIn: European Semiconductor Industry Association Medical devices sector: On the phasing out of SoC and sustaining EU innovation Global Sustainable Chemicals Lead - Siemens Healthineers 24 MEDICAL IMAGING and THERAPY DEVICES: an introduction The Medical Technology sector, plays an essential role for the running of hospitals, clinics to the benefit of society, improving healthcare through early detection, screening, prevention, and treatment. Medical technology is among the most innovative in the world. In the EU, healthcare drives patenting activity, givin g the EU a decisive competitive position globally. Particle therapy installation Magnetic resonance Computer tomography X-RAY Complex, globally competitive products with long design cycles COMPLEXITY AT ALL LEVELS Typical MRI unit weighs approx. 10 tons 3,600 assemblies 27,000 sub-assemblies 120,000 component parts More than 1,000,000 "articles" Typical extended supply chain: 5 - 7 levels About 11,000 suppliers distributed in the world 10 different languages INNOVATION/SUBSTITUTION IS A COMPLEX AND LONG PROCESS Long design cycles 7 years design cycle for imaging 20 years for IVDs 11 years for radiation therapy 10 years of market availability Since the `70s, only 5 generations of PET scanners High value devices, low unit sales numbers Limited purchasing leverage even on 1st level suppliers Regulatory The Medical Device Regulation (MDR) 2017/745 is one of the most complex legislations in Europe Very high costs for substitution 400 millions per company to re-design MRIs to accommodate new lead-free chips 100s millions to remove 5g per year from x-ray tube bearings Substituting PFAS in the medical device sector Analysis of Alternatives Identified uses undergo case-by-case analysis of potential alternatives Alternative materials lead to potential changes to manufacturing + design Rigorous testing, uncertainty as to result Elapsed time will depend on technical feasibility > process starts again if tested alternative is not successful Why we need a solution Medical devices being removed from the market as redesign is not possible Medical devices being removed from the market due to non compliance of suppliers far-away in the supply chain Many PFAS are not on any regulatory list and are non-hazardous, no legal obligation to communicate in the supply chain A cost/effective solution for PFAS: the "Legacy Device Approach" CRITICAL 1. Exclusion of legacy devices (to include manufacturing process) (avoids diverting resources from R&D of innovative medical technologies) WITH 2. Long transition times (to substitute, to collect evidence of no alternatives) 3. Long validity of derogation (where justified) (to look for alternatives and validate them) WITH 4. Possibility to ask for derogations after the end of the transition period (time is needed to test alternatives and, if conclusion is none is available, submit a derogation request) A possible cost/effective solution for PFAS : the "Legacy Device Approach" New Restriction 2018 2019 2020 2021 Already adopted by RoHS successfully across several exemptions Questions? http://www.cocir.org www.linkedin.com/company/cocir/ www.twitter.com/COCIR