Document EqRzGBOgnx4K98OgMMaOOV8b4

PFAS: The challenge for highly regulated and essential sectors (FI0]ILSL PP) Event summary FIPRA | chemsec efsia SIA Soci Introduction Over the last few years, PFAS (per- and polyfluoroalkyl substances) have becomea global concern and a priority under the European Union's Green Deal goal to achieve a Toxic-Free environment. Restricting PFASeffectiviesflayrfrom easy. Challeningtehse implementatiofn PFAS reguflindaoptposiitioonnfrsom PFAS produancdeusrerss,politcal objections, economic challenges, anda ackof consasetointsgsrouupisng and scientific-based hazard qualification. This hybrid event, organised on December 6, 2022, in Brussels, hosted key stakeholders from the industry and NGOs to discuss the associated human health and environmental risks whilst ensuring the continued availabilityof services andproductsessential tothe wellbeingor welfare ofsociety regulated essential sectors, and what we cal the "PFAS challenge". Thereis no doubt that with everytthhaitnhags been written, said or published on PFAS in many countries around the EU, there are different waysofdealing with those chemicals Now, four Member States with Norway are working on a REACH restriction proposfoaral categoryof chemicals called PEAS. When we look at the EU PFAS restriction proposal, soon to be published in January, it will create aprecedent for the frst time for placing such a large classofchemicals through a restriction process There is no doubt thatothertopics will have a big impact-we have been hearing or participating to many events about the Chemicals Strategy for Sustainability (CSS), discussed essential uses, generic risk assessment, grouping of chemicals, as well as discussions between Members States and the Commission on various platforms such as CARACAL and the Rome Council. Those initiatives are linked in many different ways, although we will have to wait to understand the full implications until the REACH revision proposal is published, and eventually adopted. Meanwhile, the PFAS proposal, following the current REACH restriction process, and given the extraordinary number of substances and uses, is not a minor exercise. Panel discussion chemsec ChemSec is a Swedish NGO founded by national governments and private charity funds. For the last 20 years, their goal has been to drive political discussion on the most harmful chemicals, supporting companies in their work towards substituting these chemicals in all but essential uses. Tools already developed include the "SIN List", and ChemSec Marketplace as initiatives to help companies find ways to substitute harmful chemicals, and work with policymakers, as well as investors in the context of the ChemScore, the chemicals ranking of companies that aims to strengthen transparency and face up substitution plans on PFAS. Many scientific reports shtheo urgw ent need for change. PFAS are present inourdrinking water and our blood. Other recent reports state that we are overstepping planetary boundaries when it comes to chemicals, meaning that "business as usual" is not an option anymore. wEshsiecnhtiwaillusleesadatroe aanbeotptpeorrtpurnoitetcyttioonfoocfuhsutmheanPFhAeSaltbhananodn twhiedeendviisrpeornsmievnetc.oWnesucmaenrfuosceuss on important cases and phase out for the restof the uses. I's not about the importance of specific products -- it is rather about when we can accept very hazardous substances. Essential Use concept needs to be clearly defined for the industry in order to differentiate the "nice-tohave" from the "critical need" In this context, the PFAS movement, started by ChemSec with other NGOs, consists of more than 200 companiesinfavour ofa broad and strict PFAS restriction, all committed to phase out PFAS. { { Essential Use concept needs to be clearly defined for the industry, in order to differentiate the "nice-to-have"from the "critical need". 9 9 se3 a FL8 ii i THi 0 LHl O SR 8 LL age SBBREtR & Bg SE efpix,a acai eee The European aFpehdearrartiaocnsoafiePhiamrbmaocsenuytiocalpInrdustrieEsuraonpde Associations (EFPIA) iIntnhedpohraermawcheeurtolil cmaalrslFAtSecsaencbetfovuindeitntChoenmvaensofvecrrBingarocressdof in APIs (active pharmaceutical ingredients part of the final product), medical devices (regulated by sectoral regulation) and primary packaging (tackled by the marketing authorization of specific countries). F-Gases also constitute a part of the PFAS restriction, currently used in refrigerants, propellants, and inhalative substances. PFAS have many definitions, the most important one being the OECD one, used by ECHA for the restriction proposal used in fire-fighting foams. The 2018 definition was broadened in 2021 to include shorter-chain molecules, meaning that the scope has been largely expanded, from hundreds of molecules to thousands of molecules. However, what OECD did not do is describe a group of chemicals withsimilaror iedecntoicnal prropoevrdtieenstthheadt eisrftitofnorwasnreoguolantmoreychredsttriocdtieonc.oIrt smeoannhsowthaPtFAtShHe should be grouped for regulatory actions. TGaePrsaEptAiSendsgr)itcoSttuiiconhng'sarmeexepcetcotenpdahloocuonpaaonqadttiheneaplSyuohlp5oteopfrtpsshreoerpEteAr,iSoonwclhi,echsnadrseoetcoibteee ederrrtesctelioenrreaooffembbrorolsctteoahdeussrtyoncoansnidtersmdia oncoon nemepceeds noPloemd a rn such as fluoropolymers in industrial uses should also be exempted as they do not become product components. Regarding substitution, a better approach would be improving the products. A simple, applicable, and efficient restriction should -------- include proportional measures to address the problem A simple, applicable, and efficient of emissions of harmful substances in the i a environment. Derogations should be available for restriction should include demonstrated low or controlled emissions of PFAS over proportional measures to address the Cthe frul feecycale, ass wealel a eseserntnial uses derogations on problemof Jemissions `of harmful . substances in the environment, which TSlhaee mmaiindnnusgtdrydoerrorgmemcieoommrsm.sendets ilagvoaindinogsf tcuneodenrfinseed iambpluines)fiPnIdiAngacnrditreersitartioctitdehneteifeys een REACH sve regains he ava that matter 99 TpShhoarmumatacceesutpcioecarsltprea sogupslaeatssionaban.sdhomrualiddevbee0lIimvkpeiwaicdstespaovnoieededcn, hte-- hbeyeeEUsmaenufatchteu-- wree ooff Panel discussion ESIA, the European Semiconductor Association, represents a very research-intensive industry with a sophisticated global supply chain, characterised by a fierce competition and price fluctuations as well as short innovation cycles. Semiconductors are found everywhere, enabling the functioning of a broad range of essential products for society. EU accounts for 10% of the global production and the industry employs more than 200.000 people in the EU. waste management batteries). PFAS have many uses in the semiconductor industry, the most important part being the process chemistry for photolithography (e. g. chamber cleaning). They are also used in the manufacturing equipment and chemical distribution systems (especially in fluoropolymer articles for filtering, tubing and linings). PFAS are also found in the facility infrastructures, in water purification, chemical delivery systems and systems and finally, in the products (e. g. wires, cables, circuit boards, The PFAS restriction is a big challenge for the industry as they are widely used and essential for the processes outlined above. Unfortunately, the current state-of-play does not allow to cover the manufacturing without PFAS. The industry, though, remains aware of the environmental impacts of PFAS and started to transit from PFOA and PFOS substances to shortchain PFAS, and will remove PFHxA according to the regulatory timeline. There is great concern regarding the broad scope of the current draft restriction, which needs to take into account the global supply chain of the industry. The challenge faced by the industry is increased due to the expected rapid growth in EU production in the context of the EU Chips Act, with a market share twice as big in 2030 compared to now (from 10% today to 20% in 2030). It is envisaged that doubling the market share will require a fourfold increase of production given that other regions of the world aren't sleeping (e. g. US Chips Act). This market growth also expects that EU's research and technology leadership on small and fast chips will be strengthened and requires more than 43 billions of policy-driven investment until 2030. The industry is pulled in two directions with tight environmental restrictions linked to PFAS and F-gases on one hand, and the need for a fast market growth in the EU on the other. The industry is pulled in two different directions with tight environmental restrictions [...] on one hand, and the need for a fast market growth in the EU on the other. pont tines ~%0 CayOCtIiRs @os" SCTeOrcCtIaorRdmiaesitsnhleeytmcraemddeiioacsgasotmcaiwgatiainosgn rapenapdrrsersamednatoittnhgreaaposypedcleivfeiiccfeossre)tghmeernutnonfitngheofmoedricgalsdetvoitchees aTnodmtereoaftmvenit.n,Thpe Weidisca osechsnoloSgryovngdhseonnyy SiutsshcteioEnUscirseaenimngos phreevemnotn,k idnenocvaiticvoemipnetthtevwaoproldr.tiIon ntgheabEaUl,lhyealthcare drives patenting activity, giving the EU a `The PFAS restriction is very complex for the sector. Medical imaging and radiotherapy mdeovdicaess ecamnbwueiegsh.uputkosi10tuttonosn, rmeapdreeosfenatnsehxatlraeonrgdienaorty ohirgyh fnourmtbheerHogfhamssmebmeblrioefs parts and components but also because we are dealing with multi-level supply chains. (23,000 suppliers around the world, and a language barrier that complexifies the process of phasing out a substance). Medical imaging and radiotherapy are high-value devices M`weidthilcoawDuanictesaRleegsunlautmiboenr(sMOtRha)t,aalnsoe hfavte tomocosmpcloymwpilteh lseectgoiraolnlsegiisnlEautiroonpleike the onetime usec dRE esigen cycomlfemsiolafnE osurpdeerviccoems.panTiheescosrtedofessiugbsntidteuvtiicoens its uvebryehirghs, saonmdeatcicmeoeusntosnwlfyoar however related to R&D resources, exacerbated by the PFAS restriction. Substituting identified uses of PFAS requires a case-by-case analysis of potent alternatives, aprocessthat can takeyears for the efficiency of alterntoabteviervifeiesd. TAletqeurinraetsifviegomraotvesritaasltsinlge,adwitho upnocteenrtaiianltychosantgoetshetoesmatn.ufWaictthuoriuntg parnadctidceasligsno,viaonnd we see a serious risk that medical devices will be from the market (as redesign is not possible, andas suppliers far-awayin the supply chain would pose uncontrollable risks of non-compliance). -- The legacy approach does not eThre mporoupossewhdilesoelxuctliuoa ndinigs lceaglalecdy tohneesaMTlhi eigsamcy pn devaincde oExpesmipsttiiionnaasskiwnegfsoere athbelanket Tdpreacchstnioclaodlgaiseorsli.utnigoTnh,eealslreeoagdasycyafdaoopppmtreoRdaGucDnhdeordfoitehsevRneotHaScoDniasriedscttiev1e [im1poifwrtevanfcoecoufspohmasm!ienwgpourtoPdFAsS. king fora slanket vempten os we see th imporance of ONY = iflegacy devices are pThaansiongn otuhte PreFdAeSsigbnutofshaifdtinmgodtehelsf.ocusleongedesdievgincerastwheer erxecslouudrecde,s wtoefcoacnususoenoduerveRl&opDing excluded, we can ure our RED resources to fects 0 gutainable newproducts without developing sustainable new products without anyofthese " Taktet them. Derogetons fo nwt products wold be asked enly aver she aration harmful chemicals present. Transition times will be needed ~~@1Y'ofthesechemicals present. to collect evidence on alternatives and their substitution ~~ E------------ potential, with a long validityofderogattocionotinnuse the search for alternatives and period in case technical feasibility of known substitutes is not possible and inorder to properly explore and test other alternatives. Panel debate and Q&A session How do you see a broad PFAS restriction proposal to work in practice and to go through a erxeissttrsi?ction process as it currently *The poliwtical momentum around PFAS allows tviosifbiilnidtywaaryosuntdo tfhiendisasuree,stmraikctiinogn,itscole|atrhwineknteheadt helps. twill be complex, it will be complicated, but A fons ) A groupof substancesfoorspecificsecA torsforH which arestriction might havea toughimpact. Andonthe other hand, we take a general approach. Restricting critical areas i maybe not the best way 0-0. In'the end, it wil be a politcal decision." 22 Such restriction could work fits verysimple. fit is complicated from the start, complex derogation processes and unclear environmental impacts, and sLectaors,iitwill lii kely failfads CdS) aIfwmeuchhavbeeattneorn-sipteurafteicotn rtehsatrnichtaiovnintghaat wroerstkrsi,ctiitoins that doesnt work. Having a simple framework that [ENR PRET 1 don't think anyone would disagree that we need to phase out PFASfrom our society. What we need isto ensure there i balance and that we don't do t at the cost of healthcare. We need to find ways of doing t ina targeted approach and in the simplest way we can, using simple tools There is currently no easyway for essential ses to apply for continued use of substances subject to restrictions or authorisations. There must be a better way, either by ensuring that we catch all essential usesorthatwehavevehiclesto ensure we don'ttake essential usesoff the market. je How would a process with a smaller scope of uses as well as a more limited number of PFAS look like? Asolution would tobeto look at specific PFAS according totheir properties.Differentapproaches includetackling pPaFtOAcaannbde cPoFnOsSi,desrheodrtasatnhde mmoesdtiuhmarmcfhualinprsoupbesrttiaensc.es u git ni those groups cannot be regulated in one Lio makessenseto focus on the most harmful chemicals, because this is where the benefits would be the biggest, butwhat should beFcoonsidered isthe actual emissions. rinsioes accounttheprecautionaryprinciple,wethink yo most persistent chemicals should be included in yo criction, Ifwe have informtahattisoomneofthem do not have harmful properties, we can then have a tdhisecpuascsti.onW.eBuntesldettsotnaotkereapcetaitonthneows,aamnedmPiFsAtaSkies3fvreormy good example. We could have derogations for specific product groups where there are essential uses. But we would like to see HS Mr] hayabilannkget approach. I {x-rays noed 10-20years tofind alternatives,that's ine, ts he kev issuesfe orthis restriction. eit jr [RP RST We agree on the need to phase out the group in a precautionary approach. However, we think the restriction should focus on the industry usesratherthan the substances themselves. Inthissense the legacy approach allows continued usesofPFAS witha trict control, while allocating resources in finding alternatives Br fe "ECHA should exempt pharmaceuticalsas there are sectoral legislation and initiatives that mitigate the environmental impact of APIs, and this is nat only related to PFAS. If we don't keep those two Gsieparratledy, there will be a lot of unnecessary Merck KGaA Crm and the PFAS restrictionis awayto covtehre whole. S 2 IPFASE , and our fi `essential uses where we need PFAS, but we would like th o see ie nnovath ion and substitution, because we i - ies fron ka gv -inAfroerpmreedstehnattattihveeroefatrheecfluuorroprolnyeomaenlrtsetirnndlautsiytvrey avafiortlhesaechbemilcales. This emphasizes the importance in restrictions to lookat differentgroups eae CT 22 Arpresferomnantimaalhtealithsvecetor explained di a hhhr hefalothwf ithinm enviarsevoerynthimnRgiesEpnarttof thesame ecosystem (e.g. zoonoses). Asanimal pharmaceuticalsare essential to society, ltwouldbe recommended to take a step-by-staesp well asplace-by-placeapproach on PFASinour PEA A Commission representative asked how to devise "arestricton that, s effecatnditvhaet is broadyet nottoo broad", EFPIAspeaker suggested a simpler PFAS restrictionframework, withreporting requiarseammidedlnepotinst, explainingthata non-perfect restrictionthatworksis much better than having a restrictionthatdoesn't work. Questions? Contact us at events@fipra.com