Document y4455d5pYBRk8DxQLZRMg13V

et ti re European Chemicals Agency 00121 Helsinki Submited by e-mail Tessa -__" 3 May 2023 Product Safety I, R, Fax +4969 4109-612710 Contribution to the Consultation regarding the "Restriction on the manufacture, placing on the market and use of PFASs" Dear Sir or Madam, this paper is submitted on behalf of the companies AllessaProduktion GmbH, WeylChem Hachst GmbH and WeylChem InnoTec GmbH in contribution of the consultation regarding the "Restriction on the manufacture, placing on the market and use of PFASs". The companies all are partof the WeylChem Group of Companies. `The companies are, among other activities, manufacturer, importer, downstream- and end-user of PFAS intermediates, `active ingredients and chemical end products and articles. We manufacture and import PFAS-Intermediates,at the time being only such with one CF3-Group atan aromatic ring, for further synthesisofother substances. `The other substances may also be intermediates, which are either further processed on site or at the site of a third party. `They may also be directly exported. `Someofthe intermediates are processed in the synthoefasctiivse ingredients for agrochemicals (like Luna, Zorvec, Orondis, Plenaris, Lumisena and others) or pharmaceuticals (Fluoxetine, Mefloquine, Leflunomide, Nulitamide, Dutasteride, Bicalutamide, Aprepitant, Celecoxib, Fiproni, Fluazinam, Penthiopyrad, Picoxystrobin, Fluridone, Norflurazon, Sorafenib, Trifluridin and more). PFAS are also used as intermediates or chemical end products in the `manufacturing of novel batteries as power storage in electro mobility or for renewable energy as well as for the `manufacturing of modern electronic high tech devices, such as display technology. `Some of them are produced in low tonnage bands or are stil in R&D-stage. Most ofthe products require a sophisticated `multistep-synthesis, with several PFAS asonsite intermediates.Thisfact gives the illusionof ahighernumber and tonnage: of PFAS, while in fact tis a significant lower number of substances, which will really are brought to market. Intermediates are in the current draft definitively not specifically exempted from the planned restriction. If this will not be `changed, thenas aconsequence also the manufacturing of respective active ingredients, final products, articles etc.will get lost in Europe and will be manufactured outside the EU. Not even such products, which are foreseen as exempted, `will thenbekept in the EU, because the required raw materials maynot even be imported. We are also end-user of Fluoropolymers (PTFE, PVDF...) in our production equipment. We use PFAS-containing R A EErT A nCn Eroy teene ---- `teaqnukisp.m)enatn,dem.ga.nypioptehse,r.vaAllvoetso,fpcuhmepmsi,casleeaqlsu,ipPeFmAeSn-tcionattheedcrheeamcitocrasl,ieqnuidpmueisnsdtetstoitgralnleyydfmoardemulotfiPpuFrApSose(e.ugs.e.AbThseorrebfeorrse,. 2. ssetael,s,bceocaatuinsgesmefc.omosuftshttealpsorobceessseelescnteedefdohisghulcyhcuosreroasinvdeccohveemriacawlisdleierasnuglefourficapapnlidcahtyidornosc.hlTohriisc aucsied,isscorluvceinatlsfworhiocuhr prevent usage of other polymers and high temperature resistance. cFhleumoircoaplolpyrmoedrusctairoenussceoduladsnsoetalbseadnodnetoaptraoltewcitnhoonu-tfstihsetsaentmamtaertiearlisa.ls,Thfiseisnctleu,desb,y omreaenxsamopflei,nagl ocrhlcooraitniatnigonMaonsdt bromination, al reactions in which hydrochloric acid or other aggressive substances, solventsorgases are used or formed or where higher temperatures are needed. TDhueeretfoorhei,ghegd.emaalmnodsstoalnl ethxehatuisgthtaniespsiopfessyasntdemsscrtuobbaevrosidareemimsasdioensofatnhdesleeamkast,eroitahlesrocruratelnetaystanvaeidaoblrecomaatteerdiawlistchan eonalsylybechceocnksiedderbeydlaoskisnugbstaitttuhteesmtaotearivaelryprloipmeirttedy eaxntdenatppalnidcaatrioenaltanbloeslsasvapiearbsliestoenntinien tfhreomenmvainrounfmaecnttu.reTrhsisofcsaenlbse, `hsouscehs,eqduriupmmse,ntcoeavteinngmsoarned, nteirssi.s eAvsenthmeonreewcGiefrimcaon TaAc-hLiuelvtehwaisthiogthhteernadvatihleabrleequmiarteemreinat.s regarding emissions fom Ishfolrutortoepromlcylmoesrusrielolfomtanbey emxaneumfpatcetdurfirnogmfthaecireesstriicntitohneatinedaussttryunvtilsruietsabulletanmduspterbmeitpeosdsailbtleerntaoticvoenstianrueefotuhnedu,steheonf oipnevreasltimnegntpsaritns,awhsihocrhtatrienealarnedadwyoiunsltdalalelds,ofeonrtianldepfrinoidtuectiimoen,dboewcnatuismeerseopflamcoinngthtshetmo wyietahrosut(fnrecsepsesciitaylweoquulidpmceonstt).huNgoe company can handle that. That would also exceed the capacities of the disposal and recycing industry as well as most manufacturoefr ahem, WIfatvheeuosfedoef-nsduucshtrmaatleirziaailosnisevneor.loTnhgiesrwpielramfiftecet wlilthboruatnacnhyessuobfsiintduutsetsryavaanidabnloettjhusetn tthhee EphUarwmilacfeaucteictahle maonsdtcmhaesmsiicvael industries. Thhiigsh-aplesrofaoprpmlainecsteomaftuetruiraeltse,cchlniomlaotgeiea,ndsuhcehataspeunerrgsyyssttoermasg,eealnedirboatmtoebriyltteyc,hnmoelcohgayn,imcaoldeenmgienleeecrtionngicesfca,nad diwspellayas,s lpohnagremracbeeuatviaciallabslea.ndRc&rDoponprtohteecftiione.odfEvPeAn SREwiDllwnilol lboenige,rbbeecraeuqsuieremda,nbyeecqauuispemtehnttwainldtshyenttheatkiecpbluaicdeiinngfbilrodcckosuwrililrneos infuture, "The socio-economic impact wil be extreme in Europe, which then wil be full dependent on foreign countries with al eInnvtihteoonpmpeonstiatle,atns pgooliintgcatloiemtpliractahteironwotrissewitlhlaanvbee.ttAen,dbeacllatuhissewtihletmaakjeorpiltaycoefiktnhownno baelneefmiatloirvetsheuseunavlilyrosnhmoewntpaotorale.r performance, higher aftrion and owe durabilty, which ads to shorter maintenance intervals, system falures and higher waste volumes. Fcormopmleateplsyycrheocloongsiidcearledp.oinOtbvoifouvsielwy,, tihnisEudrraofpteroenguelactainonnios laolnrgeeardybedesvuarsetatthiantg.onIen'vsesitnmveensttmpernotjsecwtislapraeypoofsftwphoenendthoer floodgates are open to such arbitrariness. Wiseavfauilllaybaleg,resehotuhladt PbFeAsSu,bstwihtiuctehd.haHvoewebveeern,shhioswmnutsotbbeevderoynehaornmftuhleabnadsifsrofwhaincihnadivsiudiutaalblceasaendbyeqcuaisvaeldeenctiastioenmaotrifvoer smal groofsuubstpancses and banon an enti iass with many defined applications, like thousands of substances in case of PFOAs and firefighting foams, and countess applications and arts. but nobty a blanket In addifon, atemalives the are jauvsaiifaibclaei,onussihnogulsdcieexnptliaiicnaleyxascotulnydwshtyuditehse. individual substance Otherwise, he fatal or group suspicion should arses be banned and that chemicals what policy swoainttsmutsotigbneorbeasnnceed"nt nanodteaccoonnofmidiecnfcaecdtnsspoirirng aeppraooafcshc.onoTvheirnsiewniscleoleradpoulsibcaaclkextopetdhieenDcayr.k"AgWees.doTrhtaktnsowexaancyttlhyintgh,e message of this daft a 2 Emissions n the end-otfe phase: RinegAra.rd1i7ngatnhde1P8FAoSf-RnEtAerCmHe.diTahteesentdh-eomfainfuefapchtausreinigtahnednuesxet treaakcetsipolnascteepu,ndwehrerteiitt yis ctootnatlrlyolceodncsounmdietdioinnsthas sspynutihaetseids of another substance. national and European Emissions fe waste water, ai regulations and the permissions emissions, waste of the authorities. are minimized and controled according 10 the oIfntthheeceansdeoofffaecipvheaisenigsrceondsiifdeoernrtethdesfoargraipcpurltouvraallsaancdcoprhdairnmgacteoutthiecsael rinedguusltartiieosn,sthe isk management and the estimation iTnhsemamlalnuqfuaacntiuireesd sanudblsotranacreesatfoRre&lDe-csttroangiec.deBveiccaeuss,deitshpelsaeyssuabnsdtabncaes taraetrteolilenmoarunrucfiaocmtepuarnseydfaorctuhesttoimmeerbse,inwgeprhoadeucneod iwnhfeonrmraetiaocnhianbgoutthetcheomemnedrcoifatlhescIafle,cycilfet.heMroessttilcitkieolny most ges of these in fore. substances will no longerbe manufactured in the EU 3 Emissions in the end-of-ife hase (Recying and deposition): `"aTnhde Ghaenmdainnyg.ofTwhaestseamseraepgpulliaetsedtocowmapsrteehemnasniavgeelmyebnyt,lawwaasntde risecsyucbijnegc,t twoasextteendsiisvpeoswaalsatnedlewgaisstaetosnhiipnmbeontthsEaucrroopses national borders. Ofcourse, tis #5 apes to al waste containing PFAS. WiansdtuesticroynnthaaiznainrgdoPusFAwSasttheatincciannenroattorbse(SrAeVc)y.cleTd,heesfpfeicciieanlcyy of9s.ucnhors-ypsotleymmseriincGePrFmAaSn,yisanidncEiunerroapteedsivnetrhyehicghhe,rneivceanl mmiunneircailpiazledsyasntdelmosr eamcihiteevdeawselHlFoavnedr C9O02%. dTehsterurcetqiuoinreomfesnutcshofcwoamsptoeunledgsi.slaItniotnhaesned prlealnattse,dtahreeafsuoofrloapowlaylmieerasdyareensfuulrley aathilghlelveevlesloofftphreotweacsttioenhfioerpaerochpyle(faunrtdhetrheuseenvaisraonpmreondtuoc,r rtheepahraantdilionngfoanrdeudsies,porseaclycolfinmga,teortihaelrfroewcsovceornytoairndiinsgpoPsaFlA)S.. Sofcrsaupcphepdroecqeusispmisenmtormeatdhaonf1P.F5A00S-Cc.oaUtneddeorrsiunchedcosnedeitliohniss, ihs enoPrmFaAlSlycroenctyecnlteid lbybtehedestseteolyienddusctormyp.leTtheelyt.emperature 5 Proposed derogatons - Tonnage and emissions: N`wohniceh omfetahnesptrhoaptomsaendufdaecrtourgiantgioonr iismpaoprptliwcialbnleo floorngoeurrbuesepso.ssTihbleeifftluhoerorpeostlryimcetriosn(iPsTsFeEt,inPfVoDrFc.e... are not exempted, bNeo pdreorodguacteidowniftohrininttheerEmLed.iaTtheast iwsilfolrsesoeeanf,ecwthiprcohdumcetasn,sw,hitchhasaellsoaprreodouctsb, owjhfidecerhogaarcteimotnasd,eifkreotmhethacetmivceainngnroedlieonntgse.r 6. Missing uses -- Analysis of atematves and socio-economic analysis t"Thheecursae,asthientteerrmme"idnitaernmtedhieatsey"ntchaensibseoffoaunncdthtehrreseub(s)tianmcees,sbnuottncootnsinidceornetdexi! tohf dreerosgtacttiioonn. drTahfte. oInnltyhedemraoignatpiaont ooff Afl,uowrhoicchomcpoonucnedmssamsainnutfearcmteudriiantgesainsdfouusneds,atthpeagtee6m5iasnudsceodrtnwiiccees, sbuubtstalasnocenso,tiwnhiccohntaerxetewxiptihcatydenrootgPaFtAioSn. oIrn APnFneAxS: iinntteerrmmeeddiiaatteess.,itThhairsdlmyakcaensbeiacslseaurmtehdattohbavitoiusslhyapipmeponretdanatccuisdeesntoaflPFAS were not considered. In the case of the dTehraogaistiaonssevweerreegaapppiincatbhleeproorponsoat.l,Tshiantcewotuilsdwoauffledctepahdartmoactoetuatlilcoasls oufseasll (PaFctAiSvepirnogdruecdtiieonnts,indEeuvriocepse)naosmwaetllteasif Iafgtrhoechfienmailcparlosduacntdooftthheer susyenst.hetSiocmreouotfesisucahmsoulbesctualnecewisthhaateCFo3lgyroounpe,CtFh3e-ngrtohuisp,muofsttenbeboiuntnrdodtuocaend aatraonmyaseipngin the tchhies.miTchaelresyinsthoebsviiso.usIlymingohtpboe tshatsiniof2sbmuubilsitlisttutetpiyosnynohfetsh'esisneevremreadliaPtFeAs.S intermediatesmustbe manufactured t achieve 4 (Stofmueotriommeesthaaneprsoutiepchtioornicgracoiudp) imsuasntimbpeorutsanetdprinottechteiosnygnrthoeuspiasnodfpraoncoetshseirngchaeimdincalorgsaunbisctasnycnet.hesiTsh.eThTirsfastueb-sGtraonucpe and the intermediates made from t aso are not exempled, which would ininge even the manufacturing of non-PFAS compounds. "There is also no derogaion or substances, which are produced solelyforexport outside the EU, e.9. as intermediates or monomers. TEuhreopues.e aTrsimsoinsommoesrt ifkaellsyonnootttehxaetmipmtpeodr,tawnth,icbhewcaouusleatsheo lperaoddu0c:tiotnotoafl bsuacnhofstuhbestmaanncuefsacatlurreiandgoyftfalkueosrpolpaocleymweirdseliyn outside the EL Adesvidceesscribneodtaebxoevmpettehde. mTshtatismpaolrstoantthegaapppliis,catthiaotntvhiethustehoeflfolwuesotroepnovliyrmoenrmsenitnaelqiumippamcetn,tboefcathueseprtohceeesqsuiinpdmuesntrtyisfainxdeidn and enclosed in the instalment and used for many years. At the end of the ive cycle, it may be recycledor disposed as waste according to applicable legislation. Conclusion: "ETuirsopre.estTihceonr,esfutliwngerseoctoioc-oemcoenonmticfdoracmeaugnechcaanngehdar,dlaysbethqeuapnottiefniteidalatnodcwaiulsepelramsatinnegndtlaymaangde stiogtnihfiecnatnrte riendduucsetythien `neeceodneodmifcorptohweepruropfoEsueroopfee.colTohgeicadlacmoangveerasfifoenctasndalimnotshteailghstecatgoarisnsofcltihmeateecocnhoanmgye,.iUnrcgleundtilnyg nteheosdeedthiantveasrtemeunrtgesnvtilly pcerrotdauicntlys sbuechquaesstpihoanmedacveevrtyiccarlisc,alcyhemuincdaelrs,suhcighh-ftreachm,eweolrekctrcointdyitsitoonrsa.geThteechindoelaogofy abrnidngoitnhgerpsrobdauccktitoonEoufrsoepnesitihveen an completely be abandoned. We therefore demand 1 Manufacturing and production in the EU must continue o be possible. Import and use of PFAS intermediates are essentaforthe manufacturingofifrent end products, eg. active ingredients and other derogated products. Especily fuoropolymers are important or the entire chemical and pharmaceutical industy as integrated parts of the production equipment, devices and machines. 2 Resilence in the EU must be ensured. EIutrsovpeeryunldikelrytthheatcopnrdoidtuicotnioofntshiiessrewsitlichtaonv.e tItombe subhuetesndsouwrtneadndthaitnvEeusrtompeen'tssdienpneenwdepnlcaensonwiilmpnoortlsonisgenrotbeinmcaretaeseidn and that the European economy is protected. Important considerations here are both the availabilty of products and the preservation ofjobs 3 "The useoffluoropolymers in the chemical process industry should generallybeexempted. "reTlhieesproonpofsleudrroeptoilcytmienr,minattsceurrirenfotrfowrhmi,chwilthienreevitaarbelycsuhruetndtoywnnosiganlilfeimcaatnitvepsa.rtsTohfisEunroolpeo'nslychaefmieccasl itnhdeusptrryo,cewshsiecsh assosiated vith the producton of fuoropolymers, but amost the entre chemical production including al downstream manuacturing processes inother sectors as well. 5 " Functional systems must be able o continue operators. oIfitmem.bueIntsmaaktennynctaoseasthcerceatorheatcuwueranernittnlgyannodamlaliemnatteinvaesn.ce materia mustbemadeavaiable ver asufficiently long period s. `Sale handing and transport conions must be guarantee cTohnedituisoens.of Ihtomsuess,t vbaelveenssourrecdoatthiangsthmardesetiocftiPonFAdSoecsannoatlshoavbeeainmyponretgaanttivwehseanfettryanseploartteidngefpfreocdtuscwtsheunndgeorocdesrtaarien transported on oad, ai, paneoships. 6 holistic approach is required when it comes to evaluating atematives. SPaFfeAlSy.oTfhleenehvaalvueataidovnaonftaageersatiivteesmmsusoftecnonesrigdyercoanlsuvmapritaibolne,s einncvliurdoinnmgednutraalbiptryo,tecetnieorng,yplaanndt rseasfeoluyrcoercoocncsuupmapttiioonna,l cwoansdtiet,iohnsa,ztahredpoaunstsprcoapnerntoitesc,onftci.nueAlfsooopeecroanto.mic factors must be taken into account, because without competive 7 Research, development and imovaton must continfoubee possile in Europe. PInFoArSddeterofikiefeopn iinnnotvhaeticoonntdeexvteloofprmeesnetasrcihn Eaunrdopdee,vietlmoupsmtebnet pboustsiabllseotioncporondutctitaonnusdeeprsoucbessst-aonrcieesnttehdaraelsleuanrdcehratnhde development (PPORD). This requires a secic exemption fom PPORD inthe restiton proposal. Kind Regards Allessa GmbH, Product Safety onbehalfof AllessaProdukton GmbH, WeylChem Hochst GibH and WeylChem InnoTec GmbH HOre.aGdilobferPtrBoidluecb Safety