Document 6B5j1rveyezjQqOLawoYp93y9

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CroplLife BN set esauosnoszons POSITION PAPER RR Sy Persistence scientific assessment and risk management safeguards under the Pesticide authorisation framework Executive summary + SPeMsSti,ciadnedacwthiivcehianrgereedvieanltusstmeedetaisn"gpebrysicshteanntc"eunthdeorintithiealpPrFoAvSisstroiucfotutnrhasel pdeesfitniictiidoen apurtohporoiszeadtiboyn fvraanmetwhoorukghartehiotrtohalbloivceosnfduosneodt wmiot Ttrheevveorrycchoenmsiecravlast,ivTehpeeyrsdiostdaengcreatdveasihnahleds.envionment + Before approval, pesticide active ingrelents aro thoroughly evaluated against POP and PBT mcoeertitahaesPpOPaoafntdrhePBsTtacnrdiaterrdiar,otghuelaatovray dleuciasoitfonothmneaksiunbgmiutnedderdRateagpualcatkiaogne11w0i7l/u2s0t09t.oIpftahnedydnoo + aRuetghuolraitsiaotnion11c0a7n/2b0e0g9ivreenq.uires a thorough evaluationofdegradation in diferent envionmenal xmpatorriicmeosntaanldguuinddeolrineasf.erOolnyt ietnhvoiernovnmiernotnamlenatnadl rcihskmaatscsacsosnmdeinttosnsbaascecdorodnintghestoe dinatteamcaotinofniaml safe uso at ace ingredientas wel2lproduct ove, approvalwilbo ranted. + aIhnastuheprteoxvcinetspitooinrosenqrautlheaiscttaastrdeedqiouetfiorunesnaalintmdimaceaid,piaaattneedd eerfvefpeeoncrttsoinisgdenuotfifsiseudpocahreftceeanrfnfcaedepcpltsraopvapanrldo,vaRplersgouvalisastiaioonpnsre1cha1au0tt7i/oa2nl0ao0rw9y + Wmietahsutrheen,owtransparoncy rogulaton, all safety lated datawilbomadeavaibtolthee genoral ppuabrltiecsa.ndthescientificcommunityfo active substa--anlcoweinsg further scrbuytintiornostyod + Croannsgiedoofrirneggutlhaetocroymopprtoihonesnsbivoe pdraet-aarenqupiorsetm-eanptsp,rohvae,sthicpsaiutihcoirdiezaatuitohnorciristaetriiao,nafnrdamtehweorwkidies cpornospiodseerdedPFtoA.SadReEqAuaCtHelRyesatdidctrieosns. he concems regarding porsisience hal are benind the Appr+"ovallfacnritaeriiae: substance u the cs reriaofa persistent organic pollutant (POtcPann)ot be approved + aTsheapefsatteicaidned (cbueth-aofvfiocrriteorfiosnclivoe osuakbtfsiterasntd)c.es in the envionment is compared o conservative persistence criteria. Compounds re dented a `persiisttoeynat the acceplaie degradationf + I5f0a%n (acDiveTis5nuwba0stte)arnc(e40is-6p0erdsaiysst)e,nts.oilbiaonsdccsuemduilmaetnvte,(1a2n0d-1t8o0xidcay(sP)B.T) it cannot bo approved as a paesCtaicniddied.alIofforpeSrusbissttietnuttiaonnd(aCISh):ribnithoisaccacseutmhueolarpatprtooecval(PiB foorrPTon)lyt c7anybeaorasutahnodriazledproondluyactss containing suaCcSahr sub1j.2espcecital assessment or akematives uring theapprovalprocess at national level (leading to substitution). Dina'tsoal,reaquqiureamesnytsst:emtshearsegwuelllat2oryaisasreossstmeanbtsirhequainreesptirmaotvioinoospfeiGrLosiPnstsetundciee.s allowing standard protocols +" Emxeptearbiomleinstmalindastoalun(adeerrobliacboarnatdorayncaeornodbiiocnsmemtuasbtoliashmiayasndbesporovpihdoteodlyasbios)utadnedgraindatwaitoenr,anidn i`nwaitreirs/sIedinmevnt esysstbetymsm,ieaagnndsauonftdQereSAtdhRe ccoanldciutliaotnisoonsf.hydrolysis and aqueous photolysis. Degradation FGrropaLfonEScuecroioonpipsoefht|h9eRoBuuensiGneeusmsCaorud|t1o04B0rBorsueslse|lrs|oBpikogouu|uBpmEar0o44p7i6s1e8s8r7o1sRsa.y |wewcorfgoepgtaieloPoeurcsrpoen.ssu Tel6+635152507F2ax 4322663 1380 PosR+InROMaelTst2udies. al significant metabolites must be dentfied (those which excoed either 5% 1or811102%02o1f + tIhiethaepplalbieDdTcSo0mpinousnodl,ofdethpeenad.inogroannythmeajstourdmyetlypaeb)l.te exceeds 60 days (at 20C), the degradation myeuasrt,bthefaurctchuemruilnavteisotnigiantesdoiinmfuiesltd dbiessiinpvaetsitoingattuecdibsy,lIonhgo-teDrmTfeudndstourdfieesdocromndoidteiloncsalecxuclaeteidonss.onIen + aThdetiloabndpaotsatofogristthaetaicotnivmeonsiutbosrtianngcceanmubsotrbeqeuigreenderbaytaeudtihnoartsl.east four soils and in two aquatic sthyestdoamtsa.sTehse alroedmdoartoa emxutesntsibvoe,geannedrattyepidcaaltlyaamlsioniimnudumdoef dfoeugrratdeasttiiontsdaaacrforsosmEaudrdoipteio.nGalenEeUraaln,d + nInona-dEdiUtosno,lst(he.eg.lfarboomrNfoiretdh ADmTerSi0ca)v.aluos aro used for exposure assossments, io. Prodicted EfonrvitrheonamceinitvealsuCbonscteanntcreatainodnsall(PmEaCj)ornmestoalb,oglriotuesn.dwTahteerc,alscuurlfaatcieonwsataerre adnodnesewdiithmepnhtysaircoalclaykublaasteedd, mreegcahradniinsgtiscolmoadnedlwseaatnhderthceonudsietioofnsp)rferdoemfiancerdosresalEiusrtiocpew.orTsht-ecaPsEeCevnavliureosnmfeunltlalconssciednearripooste(n6ti5a.l + aEcxcpuomsuulraetioofnn.on-target organisms fo the relevant PEC must nt resul in an unacceplabe risk 0 hose oorrggaanniissmmss.aTchreosrsiskalastsroepshsimcelnevteslsbaansdeuosnesexatpepnrsoipvreieaftfeecstadfaotlay ffoacrtaorrsan(ggeaonfaarqaluyatbioctawnodetnor1e0satnidl + T10h0e).reRsiuslktsasosfaaoscsmoomnptrsehaeronsdiovneosfeoarrtchho aocfttivhoessucbiesnttainicceesraastuworlel aarsefoirncalllumdaejdoirnmtohteabaoultthoorsi.zation ddoastsai)era,ndanedffaellctrseloefvaantcopumbploiushnedd mduastat wbiethcroengsairdder0edexinpotshuerreis(kinacslsudeisnsgmee.ngt..adTdhietosnaalmedeigsratduaetifoonr monitoring data: All avalable monitoring mustbecolleced and presented in the authorization dossier. `Gui+dancEexpdeorcimuemnetnatlss:tuadviaeislaalbefoaltloEwUthleevaelppbruotproifatteen OcoEmCpDlegmueindteleidnebsyannadtigonuaildagnuciedadnocceuomne:nts + Modeling studies follow EFSA guidance documents which also describe the scenarios to be used RFoilslkowimnagnthaegaeppmreovnatl osfaafnegacutaivredisngurenddieenrt aRteEgUullaotvei,oon 1t1he07a/ut2h0or0i9sation of a product in EU Member aSuttahtoersi,titehsesRheoguulldathieornepbroevaidneysnseewvecraolncmeercnheamneirsgimnsg.allowing forthe proper monitoring and rapid reaction of + pArsinsctiaplteedthinaAerntisculrees1 stuhbesptraonvciessioonrsporfoRdeugcutlsaptliaocned11o0n7/th2e00m9arakreetudnodenroptiandnveedrsbeylytahffpercetctahuetihoenaalrtyh of humans, animals or the environment. inclucing situations where scientific unceriainty about risks. pexriistnsc.i'Fuorfth0e2r.0d2e.t2a0l00i.s given in the `Communicaion from (heCommission ontheprecautionary. + TRahpepeovratleuuartiMonemsybsetremSolfaAtelss caolnrdeuacdtys.invtohlevemsainnumeevraoluuastiaocntorisn wchoincjhunicntciroenasweitthhethoevercaol-lRsacprpuotirntyo:uar TMheemnbetrheStEatuer.opAelaonthFeorosdMeSmafbeetry AStuattheosratseswewlilasortghanpiusebiac apreeerabrleevtioewcoomfmtehinstwoonrktiasnedvaplruaotdiuocne. ordendiocnat-eadpcponrcoluvosfaialonss.ubBsatsaencde,onbtahseedEFoSnAavCaoinlcalbuesiiosnktmhaenEaUgeCmoemnmtisosptiioonnsw.ilSurcehcormemceonmmdeanpdpartoivoanl + wAirltifclie 4n(6ba) vsleotltseyodutondebtyaaelldErUeqMuiermebmeenrtsSt0atebse.met, among others, to avoid unacceptable effects on + tAhretieclnevi6roanllmoewns.to grant approval with conditions and restrictions to limit the use of plant protection + pArrtoidculcets14osretosmmpaoxsiemurimskpmeirtiiogdastinoontmeexacseeudriensga1n5dymeoanristfoorrinagp.proval afer which a ul review is again + Arerqtuiicrleed2.U1npdreorvisdpeescisapelcdiefriocgmateiaosnus,reasrteovrieevwiaefwearnaemxaisxtiinmguampporfovayleaartsasnyrteiqmueir.eA Member State cmoannirtoerqiunegstdastuach reietwo te Commission in the ight of new scientific and technical knowledge and + PinroedaucchtsMecomnbteairniSntgataens raeuctehiovriinsgedanacatpipvleiicnagnrtesdipernotdulcstodonseseidert:oabdediatpopnralovsecidenitnidfiivciidunaflolrymaatfitoenrwnaeredds to be provided also to saisy national specific requirements (e.g. NL. and water protection: DK and fPrearmseiwsotronkce scent assessment and isk management safeguards under th Pesticide authorisation 213 poseiLpoersseisnt2ence). Member States can alo impose speci exposure miligaton measures of msoanri1t1o2r0i2n1g + rAetqiucilroem2e4ntlsa.ys down conditions of a limited approval period if the conditions of a "candidate for csounbtsetxuttoofna"taormeamieitv,e.tgr.eaplemresnitstmeenctehoadnsdtwoixtichitayemxocreeedaicncgephlaebleelorviaskntprhorfeis,hotlhdesleeve`lcsa.nAdgiadiantsets hfeo.r SSutbastteitsutairoen'remquaiyrebdetorecsatircyteodulinaucsoemporardaiisvcoentaisnsueesdsemnelnretlyt.halAcwceoirgdhisnguptotAhretircilseks50a,ndEUbenMeefmitbseorf + Autsiecsloor2en9tisreetsprooudtucrtesq.uAicrceomrednitngslyt.o baeutmhoerlisfaotiopnlsanmtapyrotbeectaimoennpdreodduocrtswiitnhedarcawhn.EU Member State + UfonldleowrinAgraticrleev3i6ewaofMethmbaecrtivSetastuebcsatnanrceeucsoentaautihnoerdistahteiroeninofataEpUlanltovper.otection product authorised in ahnuomtahneroMreamnibmearl Shteaatletfotr tchoenseindveirrsontmheanttt.he product in question tl poses an unacceptable risk fo + UapnpdiecratiArotnifclceer4t3ainarMeqeumibreermenSttsataorecannotrmeeftu.se the renewal of an authorisation after review of an + AmeMaenmtbaenrySmtoarteeorcnaenwwciothndcreamwsaenmaeurtghoer(iAsrattiicolen atany 4). time if f considers the requirements are not + ASpupglgiecsatnststhaereproobdluicgtednounldoenrgerArctoicmlpeli5e6s (w0itrheepxoirsttitnogErUequMiermembeentrs.StaEtUesMaenmybenrewStiantfeosrmmaatiyonadtohpatt itnhteeerinmviprroontmeecnitv.e measures, amend or withdraw the authorisation to avoid any unexpected effect on + aEmseurbgsetnanccyemiesaiskuelryestoacroenaslistotfeoraesseeernou(sArrtiisck,lean69d)tshahtosuuchimimsekdicaatnenoEtUbelecveolntaacitnieodn sbaetinsefaecdtoerdilyif + bTyhemeEaunrospoefanmeCaosmumriessstiaoknenibs yalstoheemMpeomwbeerredStfaotea(cst)ocnonlcseronwend.in cases of extreme urgency (Article + 7I0n)t.erim protective measures are also possible at Member State level should a rapid response be needed (Article 71) aFdudrtihnegratno etxhteraelleamyeerntosf spcrrouvtiidneydbbyyharvegiunlgattihoena1p1pl0i7c1a2t0i0o9n,dotshseieTrrafnorspaanreacniciyveReignugrleadtiieonnt 2m0a19d/1a3v6a1ilibslaelsfoo tRheegupluabtilonatihtehelebveeglionfniancgceosfsthbeyvaaclaudaetmiiocns,prootcheesrs.reCguoluaptloersd awnildh tthheeppuubbllicictocounnsduelrtlaytiinognsscfioernteisfeiecndabtya hiils reinforce the scrutiny and ensure all extemal contributions are considered in the scien evaluation process. Risk management safeguards under the Water Framework Directive (Directive 2Th0e00p/ur6p0o/sEeoCf)this Directive sto estaabflraimeswohrk for the proteocfdtifieroennt types of surface waters. aspnedcigircoumndewaatserutoorrpetrhosetecptraongrdesesnihvaenrceethde purootfcedcittsicoinhaarongdensi,mepmriosvseimoennstaonfdthle aoqusoalfiscpreeinovsriryosnumbesnttantcreosugash. wel+as tAhtipcolleludtiroenqoufirgersouEnUdwMateemrb.er States o implement the necessary measures fo prevent deterioration of the status of all (hazardous) proiy swuabtsetranbocdeisesm.ayWbiteh ctehaeseadiomrtophparosgereosustively reduce poluion, emissions from + UofndwaetreArrsttiactlues,8wEhUicMhedmibsteirngSutiastheess sbheatllweeennsuproeintthaenedstfaubsleisshomueronctfesparsosgtraadmimnfAeorrstitchleem1o0n,itoring + Adretvieclloep1e1d adnedscrreigbuelsartlhyebe`PrreopogrrtaemdmteootfhemEeaUsuCroemsm'isisniwohni.cChanuasteiosnaolf pcoonlitrolnphraovgera0msbehaavsese(sosebed: aNnodmbmeerasuStraetsestakaerne troecqouinrreodl ttohesree.viWehwerpeermmointi,toardijnugsotrmoofnfietrodraitnag ipnrdiocgartaemrseaasnodn ftoarkceonacdedrint,ioEnaUl + mNoetaasluirsessuteossmtoapydebtoersioolravteidonb.y individual EU Member States (Article 12) and may be reported 0 the + TEhUeCEoUmmPiasrsiiaomnenatndanadnythoethEeUr ECoUunMceimlbaerre mSatantdeawtietdhtao raedcoopmtmsepnedciaftiicomnefoasuirsersesaoglauitnisont.pollution of water as outlined in Article 16. These measures have {0 be included in the national programmes of + TDihreecEivUe,Cotommaidjsussiton insewrelgyuliadrelntyifuipeddattihnrgeaths oflsptololfuipornio,rietqyusiufbisntgaEncUesM,ermebleatredSttoatAenn{0eaxdaXptofthheiis programmes of measures fo these changes. fPraarmseiwtoornkce scenic assessment an risk management safeguards under the Pesicide auhorisaon a3