Document DMmeOOE95rbjJ4XbVo1dY90Do

France, Ministry of Ecological Transition Directorate General of Risk Prevention PFAS Restriction Proposal and medical imaging and RT devices Brussels, 02/11/2023 In June, I contacted you addressing the proposed "Restriction on the manufacture, placing on the market and use of PFAS". The proposal does not provide any exemptions specific to medical imaging and radiotherapy equipment, including those devices that form an essential component of modern imaging or radiotherapy procedures. In the meantime, COCIR has submitted two contributions to the public consultation on the Annex XV restriction report. Part I presents technical justifications and a socio-economic impact assessment for an extended derogation to substitute the many applications of PFAS in medical devices. Part II analyses in detail PFAS usage currently identified by offering case studies highlighting the complexity of finding alternatives, often unavailable for years. The PFAS most commonly used are fluoropolymers. Additionally, COCIR provides its estimate of PFAS tonnage used in Europe and showcases the impacts of a no-derogation scenario on healthcare from a socio-economic point of view. Please find a summary of the two submissions in the attached document. Medical imaging and radiotherapy devices are already subject to stringent regulation under EU Regulation 2017/745 (MDR), prioritizing patient safety, extensive testing, clinical evidence, and risk management systems in product certification. Substitution under MDR is a lengthy process due to the complexity of devices and the extensive testing and certification requirements. Thus, without an extended derogation, COCIR anticipates a potentially dire situation not only for the industrial sector, involving the loss of the entire EU market. What is more, without an extended derogation, potentially millions of patients may not have access to examinations and treatment within the EU. COCIR recommends a 13.5-year derogation for key medical devices, ensuring at the same time no limitations on contrast agent production. We also propose a review mechanism for extending derogations with a 3 to 3.5-year evaluation process for specific applications. We kindly ask for your support in acknowledging the mentioned concerns, to ensure the continued availability of medical imaging and radiotherapy technologies for the healthcare sector in EU/EEA countries. Please do not hesitate to contact us with any questions you may have. Yours sincerely, COCIR Secretary General BluePoint Building - 80 Bd A. Reyers - B-1030 BRUSSELS, Tel.: +32 (0) 2 706 89 61, 1 http://www.cocir.org/ Transparency Register: 05366537746-69, VAT: 478.589.387 SUMMARY NOTE Part I & II of the Submission to the uPFAS public consultation This document provides a summary of the two submissions by COCIR (the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries) to the public consultation on the universal PFAS restriction proposal. Part I of the COCIR submission (June 2023) provides detailed technical justifications for an extended derogation and includes a socio-economic impact assessment of the proposal. It primarily focuses on medical imaging and radiotherapy equipment, as well as other crucial medical devices integral to them. Part II of the COCIR submission (September 2023) analyses in detail the uses of PFAS so far identified by manufacturers of medical imaging devices, with several case studies showing the technical complexity of identifying and testing alternatives, which in many cases will not be available for years. Part II also provides an updated estimation of the tonnage used by the sector in Europe and an extended socio-economic assessment of the impact of a no-derogation scenario. Without a derogation, COCIR expects an almost dramatic scenario for the industrial sector with the loss of the entire EU market coupled with hundreds of millions of lost examinations and treatment for patients in the EU. COCIR members support the PFAS proposal's objectives and aim to phase out hazardous PFAS in all applicable situations where suitable alternatives exist for maintaining clinical performance and to control and reduce PFAS emissions during continued use. Nonetheless, replacing PFAS in medical devices is challenging due to the many unique properties of PFAS, as well as regulatory constraints associated with this highly regulated sector. While some components can be substituted once PFASfree versions are available, redesign may be necessary if drop-in alternatives are unavailable or inferior. COCIR anticipates potential substitution within 13.5 years, but this timeline relies on all suppliers providing PFAS-free components by 2026/2027, which COCIR considers unlikely. COCIR members have been actively assessing PFAS use since last autumn, but this process is expected to take at least three more years due to the complexity of supply chains and difficulties in identifying PFAS in sub-supplier materials, exacerbated by the absence of a CAS number list in the restriction proposal. PFAS are commonly used as flame-resistant polymers in various applications, including many electrical components in medical imaging and radiotherapy devices. PFAS are also found in printed circuit boards, lubricants, adhesives, and polycarbonate materials commonly employed in medical devices. PFAS's unique properties make finding alternatives challenging. Currently, according to suppliers, there are mostly no substitutes available that match PFAS in terms of performance and compliance with safety standards. COCIR members must ensure that any potential substitutes do not lead to unintended consequences for patient health and safety or the environment. COCIR's best estimate of used quantity is approximately 26.3 tonnes of PFAS per year as a result of placing new medical imaging and radiotherapy equipment on the market, almost all fluoropolymers. BluePoint Building - 80 Bd A. Reyers - B-1030 BRUSSELS, Tel.: +32 (0) 2 706 89 61, 2 http://www.cocir.org/ Transparency Register: 05366537746-69, VAT: 478.589.387 Technical aspects The PFAS restriction presents a complex challenge for the medical imaging and radiotherapy sectors. In navigating this issue, some of the most critical technical aspects that must be considered are: Identifying and assessing PFAS applications in a complex global supply chain with thousands of suppliers is a time-consuming task, with the testing of alternatives contingent on finding both PFAS and substitute materials. The integration of PFAS-free components into new designs is dependent on their availability, which typically occurs shortly before derogations expire. This delay can significantly impact the development timelines of medical imaging and radiotherapy equipment. Companies face resource limitations, with a scarcity of specialized technicians and engineers, making simultaneous redesigns of multiple product models challenging. Some applications may lack suitable alternatives that provide the same clinical performance within the expected timeframe, potentially requiring derogation extensions. Despite advanced substance tracking tools, unidentified PFAS uses may still be discovered late in the substitution process, posing additional challenges for companies and healthcare providers. Medical imaging and radiotherapy devices are subject to stringent regulation under EU Regulation 2017/745 (MDR), emphasizing patient safety, extensive testing, clinical evidence, and risk management systems in product certification. Societal impacts Without an extended derogation, the following consequences are likely: Most medical imaging and radiotherapy devices will be discontinued, resulting in reduced healthcare access for hundreds of millions of patients until at least 2040. Normalizing device availability and improving access to critical healthcare would likely take additional time after 2040. Over a 15-year period, COCIR estimates a potential decrease of 1 to 6 billion imaging examinations due to the disposal of unrepairable older devices and a lack of new ones. This translates to an annual average of approximately 90 to 400 million fewer examinations. Reduced availability would negatively impact tens of millions of cancer patients, potentially affecting their outcomes until at least 2040. A 13.5-year derogation could reduce these numbers considerably. The recent surge in cancer cases is going to exacerbate the crisis. Impacts on the economy EU Manufacturers face a loss of competitiveness compared to those outside the EU, possibly resulting in: Job losses will be more than 100.000 when including factories, refurbishers, and suppliers. The costs of redesign will reach several billions of euros. Revenue loss of 10 billion euros and potential business closures for EU-based manufacturers. Component disposal costs for parts of approximately 100 million euros. Suppliers' costs are difficult to estimate but, based on RoHS experience, could be substantial, as 32 billion euros were estimated for replacing six substances. PFAS emissions from the use phase and end-of-life BluePoint Building - 80 Bd A. Reyers - B-1030 BRUSSELS, Tel.: +32 (0) 2 706 89 61, 3 http://www.cocir.org/ Transparency Register: 05366537746-69, VAT: 478.589.387  Manufacturing and use: Devices operate at ambient temperatures in hospitals with negligible PFAS emissions, as they mostly contain non-volatile PFAS in polymers form (with some minor application of lubricants and adhesives). PFAS decomposition does not occur under standard use conditions. Disposal and recycling: COCIR members adhere to the Waste Electrical and Electronic Equipment (WEEE) Directive (2012/19/EU) for equipment disposal. Their equipment is metal-rich and typically recycled within the EU, following EU waste regulations, including the Industrial Emissions Directive (2010/75/EU). The recycling process does not involve volatile PFAS like hydrofluorocarbons, thus preventing emissions during collection, storage, dismantling, and sorting of scrap materials. Incineration: High-temperature incineration effectively destroys all PFAS, as confirmed by recent studies. Well-run incineration processes do not result in harmful PFAS emissions. Derogation needs COCIR recommends at least a 13.5-yearderogation for medical imaging and radiotherapy devices, as well as other devices that are required to perform imaging and radiotherapy procedures. It must also be ensured that the PFAS restriction does not limit the production of contrast agents that are critical to most imaging procedures. A review mechanism should allow for extension of the derogation for uses where alternatives will be unavailable. We propose to set a 3 to 3.5-year evaluation and amendment process for extending derogations to specific applications. The "repair as produced principle" is crucial to maintaining and servicing existing medical imaging and radiotherapy equipment in EU hospitals and clinics. The Medical Device Regulation prohibits the use of non-validated spare parts, making it impossible to repair installed devices even if PFAS-free parts could be developed. In alignment with the EU's Circular Economy Policy, the PFAS restriction should permit the continued leasing, resale, or lending of equipment placed on the market before EIF. Refurbishment of medical devices also requires a derogation from the current proposal to continue ensuring affordability and sustainability in healthcare. Evidence from the RoHS Directive, particularly Exemptions 31a and 47, demonstrates that reusing spare parts is environmentally superior to manufacturing new parts, aligning with the principles of circularity. BluePoint Building - 80 Bd A. Reyers - B-1030 BRUSSELS, Tel.: +32 (0) 2 706 89 61, 4 http://www.cocir.org/ Transparency Register: 05366537746-69, VAT: 478.589.387