Document 3kXQ3e2gqBZjQwYkRn7r5wED

PFAS: The challenge for highly regulated and ih =| pr Hear Ko Assoc ~ i % Programme y FT RE (F137 ohag Panel discussion (z0min/speaker) " Ree 0 (YET 5 European Semiconductor Industry Association (ESIA) i | Siemens Healthineers, COCIR ghss Panel debate & Q&A session 10h40 Concluding remarks, 10h45 Coffee & Networking session RIN {EET; [B MING Aj N\\i/ KpFas. A CHALLENGE = To R oO)4 Sd Vv jo . 1] 0 4 WHAT WE DO AT CHEMSEC + Drive the political discussion on hazardous chemicals + tChheailrlcehnegmeiccoalmspamnaineasgteomiemnptrove Develop online tools to help companies switch to safer ferytei Inform investors about risks and opportunities in the chemical industry pA @; \ a. rr i Wl. A &'chemsec \| rr a \ V7) ~v A" L THE URGENCY + Scientific reports show the urgent need for change Obvoeurnsdtaerpipeisng the planetary + 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" 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 chemsec gs EF ds . ge FON) Ne SUE chemsec J ; PE chemsec : oo !y " x. ~ 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? EE EEE Ri ] ea9 " TTT TTT TTTTa T TTE TTT Nee) RE a(ANTI2) Eo os x : pz& 3 Ros = 2) > & P Wl NED ; ORE & ORE Ld PD), ee. +2 . 2 A 24 5 BN 2 Fo L od sr 2 %) 4 4 x > (A ; E ANT C yy > LI Fa B: A * 2 L THANK YOU FOR LISTENING . effpiXk a European Federation of Pharmaceutical Induas ndt Assroci iateios ns I PFAS in the Pharmaceutical Industry i CEH: z Nb an ma PE romain PC 3 FVee 6 Dec 2022 [OA 4 ve = efpia SFC UseofPFAS in (Bio-Pharmaceutical Production EEE Eig | PAS in IndustrialUse,notpartof theproduct y PChreamsicparlocoerss IPanrtteirlmAe7dLiate Material Molecule] 7 oIfmnadutseustorevvreiirtitahhclonustlrol TFT mT mIEENS 2% PY PFAS API Drug aSrubpsrtoadnuccet iAcfteivCeycilnegredients (30) 2 [and Medica Devices are a= regulated separately pmspar or DFAS ContainingoCoated Subition Tmpovsble (1 ==oexs)[authooPfrrtiimhzaeramyatrpikaoectnkiangging is part RawMataretsriaolrs prEoadumcoinorn Manufactur0ing9 | aareat F! = I.egultons must .be REmaindomngh roee e Sodsns n rnbgne re|s [bees || packaging Cronosrsa ara cor nfiTatpprin nege.in prasrepor ME TTrEadWuLctSioSn or [1] Jr BReRfAriSgetrhaanttsa,rperoFp-elGlaasnts, EAnalyx ticaleChemmicalp s a t Sth 5 pIanhyalnadtievenS0ub5smtacnrcecs.ron efpia SFC The OECD PFAS Definition + omc + OECD2021-8,or Fy mimes @03 g" + OECD 2018. OECD 202: Why was the scope expanded? The hinatvegntnioncorftahe PrEeASidn fof tnhe PtEAhdeafaiNniton'sanndtCtooenxapnantdcthresPAcSomupnoivuenrdsse,rboumtntecocmhpermeichaelrsriavceiynreeflpecotnt + oTfhveiteewrman`dPisSeaSsiilsy.ibmrpoleamde,ngteanbelreaf,onrodrisstpienlgufiischitnegrbm,etwwiecenhPdFoAcSsnsoatndinnfoonr-mPwFhAeSts,hearlsocboymnpoon-uenxdpesrtsh.armfulornat, but only communicates that the compounds under this term share the same trait for having a fully fluorinated methyl or Tmohneedthdvyeolcleiansmieaocrnaytroabcobtnrioomnaosdi.eetny.t"he defini. snot comncted to decions onHow FASs shodbegrouped in regulatory * s[nOdECpDrRaepcoartGuRiedcaonncienPgETASeCrenmtiranloolfogthyeUnivers of Pr. and pfctl Substances Recommendations efpia SFC PFAS Risk vs Benefit * Riskthough PAAS Use + Substances with intrinsic harmful propeties 4 persistent and ls obleou, endocrine diupting or CMI In AP, beinga PEAS notdoesnot determine persistance or bosccumulativeproprtes + Emissioonsf PEAS in Production, during Use or Endof Produet Life Pra Usewhere Risks areContralied + Proucs sujet toregulaotthieortnhasn REACH such a pharmaceuticals o animalhaltproducts, wheredata Is valablean sey emiriosk anssmesseetsnwretconaduclted + Prouction and manufcturing materials that donot become product component, such as foropolymers in Industrial use + Materials where emisions re propery controlled ver the fll fe cee which may nce production materials, butalo other macohraviiatinoneequirpmeynt efpia SFC Substitution Replacing chemicalwith safe alternative s Just oneway of lookin at substitution + More often, basic innovationphases ut harmful chemicals or othr hazards + Restricting substances based on structure, regarofdprlopeerstiess and/or ris, severely impacts R&D in all technology sectors RIimspklosioxnrays Lead HiVoglhtage Heawy neficnt CCirculhoa Hg (+10) Pras sMeonissittuirvee Lifetime ar wr ote efpia SFC Conclusion: What To Look For in a Simple, Applicable and Efficient Restriction + include + proportional measures addressithneg problem emisosfhiaromfnul substancestothe environment + Creat deni, HarmulprAS" + Derogations for demonstrated low/controlled emissionofs PFAS over the full Life Cycle + Essential Use derogtions on acaseby-case basi a a lat resort + exude + Undefined terminology an avoidable complet, leading to unceiritmpalemienntattioyn. Unclear requirementscreate effort inthe industry and the authorities without benef, slowing down substitution and other beneficial developments. - REACH aspects overlappingwith pharmaceutical regulations,o those of medical devices or veterinary products + Impacton EU manufactureof pharmaceumtatierciaalls Negative impact on innovation or resesech otra Se SIA PFAS in the semiconductor industry WeIcso < SIA `mec ESIA Members Gomer BC EE ne Cinfineon. intel BE D Rus MelexisTM qficron nexperia NMD Renesas swsitec &7 eto ene Xfob ZVeE slA pect, The voice of the semiconductor industry in Europe iRnetperrensaetinotnatlhecoimnpteerteisttisvoefnetshse European-based semiconductor industry and advocate for its + 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 Europe strongest market for automotive (29%) (+26.2% yoy) Eu + ca. 10% of global market + idnidriercetcteumpptlooyme1n.t0002.0000.0000 + ESIA is member of the World Semiconductor Council (WSC) _ SENN ca : = $3 Es IA n Ii [/ \ AlAl ! SN y / ) 13, 4 NLS 4 ESIA PFAS use by the semiconductor industry + Constituent of specialty process chemistry + Dement formulations (photolithography, chamber cleaning/etching, and other mixtures) + T>o1n3ctoypneasioefsdistinct use/s material + Semiconductor manufacturing equipment (HTFs) + Fa luoropm olymaenrdae crthiecmliecsn ailndmsatniu: bfuacttiuorning. `systems (filters, tubing, linings, o-rings, etc.) + iFeu, coler,opripinnteaodrcilreesyat(bmcooamerpdar,nesn, teres, mtators, capacitors, oe.) S FR -- s -- Chemica dlery and waste management `systems (tank and duct linings, pipes, etc.) ESIA Te 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.) SIA Context of EU Chips Act e ee--------, 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 SIA Questions? Thank you for your attention! http://www.eusemiconductors.eu/ Twitter : @eSemiconductor LinkedIn: European Semiconductor Industry Association 00Q os: AdbaucingHealtheare Medical devices sector: On the phasing out of SoC and sustaining EU innovation COCIDROfl MEDICAL IMAGING and oo THERAPY DEVICES: _ _ an introduction pa a E Bae erlponer ru 7 By EEen Sngprevniors o*N,ah J p`= proemenangfym Ek =) SieE dedi competiive poskion f ees [4 rr [ <= = Computer -- tomsglaphy Fad) a aa .%0 Complex, gl.obally compe: titive products with long design cycles 0 Soodor (T COMPLEX6I0T0YaAsTsE AoLmLiLeEsVELS + 227o0,r,0e00t00h0sacunbo-m1ap6s0os0enm.eb0nl0ti0peasarrttsicles" SThou I110e00SahyenCdRsTtoteedvnoaworld eowdeiopoimi epmsesmn on glev opis sE oma Regulatory amatcompetlim--niF--rtos ICNONMOPVLAETXIOANN/DSULBOSNTGITPURTOICOENSISS A Lon2gpevaeennsrsgisndofeprrtiveoesnvteonorthmearagpiyng overs of maker ala ey a00ccocmooomrnmstearsctoemopvaonywrltooereu-odtensign Wil to + Sr ----T--i" Sasringy oo) [eeI=l:] Substituting PFAS in the Soc medical device sector AnalysisofAlternatives. reese sr051 + Identified uses undergo case-by-case analysis of potential alternatives *Rigorous testing, uncertainty storest + Etelsatpesdeadtteimmeatwivlel dsenpoetndsuocncteescfhnlical feasibility >process starts again if Why we needa solution * Medical devices being removed from the market as redesign is not possible * Msepdiicealsdfeavircaewsabyeiinngthreesmuopvpeldy fcrhoimnthe market due to non compliance of + Many PFAS are not on any regulatory lst and are non-hazardous, no legal obligation to communicate in thesupply chain wl [i--] [i =J prem as= it] |] | - (| i | g ] eSAtE 4 = } mraz0 = Brey o Hs e Ty fr - Bry e esses 1 Yi . Bs [re |coci A cost/effective solution for PFAS: the "Legacy Device Approach" CRITICAL 1. E(txocilnculsuideonmaonfuflaecgtuarciyngdpervoicecsess) (avoids diverting resources from RED of innovative medical technologies) WITH 2. Long transition times (to substitute, to collect evidence of no alternatives) 3. (Ltoolnoogk vfoarlaildtietrnyoatfivedsearnodgavatliiodante(twhheemr)e justified) WITH 4. Possibility to ask for derogations after the endof the t(triamnesiistnieoendpedertiootdest alternatives and, f conclusion is none is available, suubbmmiittaa dedreorgaotgiaotnion rreeqquuest) 0 Wee] oer A possible cost/effective solution for PFAS :: the ""Legacy DeviiceApproach " B bria 7ewb 3 BSe EA fa bbe win7 -- --------) a Already adopted by RoHS successfully across several exemptions co 0 or HH oh aia o dkl e dankje (raci* as obri: gado = Siggygo raion =m Questions? http://www.cocir.org lin] `www.linkedin.com/company/cocir/ [7] www.twitter.com/COCIR