council direct ec march amend annex vi direct eec plant protect product micro organ text eea relev council european union regard treati establish european commun regard council direct ec juli place plant protect product market articl thereof regard propos commiss accord direct eec member state ensur plant protect product authoris compli requir provid direct direct eec establish uniform principl pursuant member state carri evalu plant protect product view authoris uniform principl laid member state evalu authoris chemic plant protect product equival principl member state appli evalu authoris plant protect product micro organ lai addit uniform principl type plant protect product requir dossier submit applic authoris plant protect product micro organ includ direct eec commiss direct eec lai uniform principl evalu dossier plant protect product micro organ base data requir provis direct protect water includ provis relat monitor prejudic member state oblig direct concern council direct eec june qualiti requir surfac water intend abstract drink water member state eec decemb protect groundwat pollut caus danger substanc ec novemb qualiti water intend human consumpt direct ec european parliament council octob establish framework commun action field water polici provis direct genet modifi organ prejudic member state oblig direct ec european parliament council march deliber releas environ genet modifi organ scientif committe plant provid opinion direct opinion account direct eec amend adopt direct articl annex vi direct eec amend accord annex direct articl member state bring forc law regul administr provis compli direct immedi forward commiss text measur correl tabl measur direct member state adopt measur refer direct accompani refer occas offici public method make refer laid member state member state commun commiss text main provis nation law adopt field cover direct articl direct enter forc twentieth dai public offici journal european union articl direct address member state brussel march council presid boden oj direct amend commiss direct ec oj oj oj direct repeal direct ec oj oj direct repeal direct ec oj direct amend regul ec european parliament council oj oj direct amend decis ec oj oj direct amend regul ec oj annex annex vi amend titl quot uniform principl evalu authoris plant protect product quot replac quot part uniform principl evalu authoris chemic plant protect product quot part ad part quot part ii uniform principl evalu authoris plant protect product micro organ quot content introduct evalu gener principl specif principl ident ident micro organ plant protect product ident plant protect product biolog physic chemic technic properti biolog properti micro organ plant protect product physic chemic technic properti plant protect product inform qualiti control product micro organ plant protect product qualiti control plant protect product efficaci identif detect quantif method analyt method plant protect product analyt method determin residu impact human anim health effect human anim health aris plant protect product effect human anim health aris residu fate behaviour environ effect exposur target organ conclus propos decis make gener principl specif principl ident biolog technic properti inform efficaci identif detect quantif method impact human anim health effect human anim health aris plant protect product effect human anim health aris residu fate behaviour environ effect target organ introduct principl develop part ii annex aim ensur evalu decis regard authoris plant protect product provid microbi plant protect product result implement requir articl direct member state high level protect human anim health environ evalu applic grant authoris member state ensur dossier microbi plant protect product suppli accord requir annex iiib latest time finalis evalu purpos decis make prejudic relev provis articl direct ensur data submit accept term quantiti qualiti consist reliabl suffici permit proper evalu dossier evalu relev justif submit applic suppli data account annex iib data activ substanc consist micro organ includ virus plant protect product submit purpos inclus micro organ concern annex result evalu data prejudic relev provis articl direct consider relev technic scientif inform possess regard perform plant protect product potenti advers effect plant protect product compon metabolit toxin specif principl evalu refer made annex iib data understood data refer point data inform provid suffici permit complet evalu propos applic evalu decis made propos take account justif provid benefit subsequ clarif member state reject applic grant authoris data gap finalis evalu make reliabl decis propos process evalu decis make member state cooper applic order resolv question dossier quickli identifi earli stage addit studi proper evalu dossier amend propos condit plant protect product modifi natur composit order ensur full satisfact requir annex direct member state reason decis month receiv technic complet dossier technic complet dossier satisfi requir annex iiib judgement made compet author member state evalu decis make process base scientif principl prefer recognis intern level made benefit expert advic microbi plant protect product viabl viabl micro organ includ virus formul substanc relev metabolit toxin produc growth residu growth medium microbi contamin micro organ relev metabolit toxin plant protect product residu growth medium microbi contamin present evalu member state account guidanc document note stand committe food chain anim health scfcah genet modifi micro organ direct ec european parliament council march deliber releas environ genet modifi organ account evalu complet framework direct provid account definit explan microbiolog term antibiosi relationship speci speci activ harm product toxin harm speci antigen substanc result come contact cell induc state sensit immun respons latent period dai week react demonstr antibodi immun cell sensitis subject vivo vitro antimicrobi antimicrobi agent antimicrobi refer natur occur semi synthet synthet substanc exhibit antimicrobi activ kill inhibit growth micro organ antibiot refer substanc produc deriv micro organ anticoccidi refer substanc activ coccidia singl cell protozoan parasit cfu coloni form unit cell grow form singl visibl coloni colonis prolifer persist micro organ environ extern skin intern bodi surfac intestin lung colonis micro organ persist longer period expect specif organ popul micro organ declin slower rate normal clearanc steadi popul grow popul colonis relat harmless function micro organ pathogen micro organ occurr effect ecolog nich uniqu environment posit occupi speci perceiv term actual physic space occupi function perform commun ecosystem host anim includ human plant harbour nourish organ parasit host specif rang host speci colonis microbi speci strain host specif micro organ colonis advers effect small number host speci host specif micro organ colonis advers effect broad rang host speci infect introduct entri pathogen micro organ suscept host patholog effect diseas organ enter bodi host cell reproduc form infect unit simpli ingest pathogen impli infect infect capabl transmit infect infect characterist micro organ infect suscept host invas entri micro organ host bodi actual penetr integu gut epitheli cell quot primari invas quot properti pathogen micro organ multipl abil micro organ reproduc increas number infect mycotoxin fungal toxin viabl micro organ micro organ capabl replic transfer genet materi viabl residu residu capabl replic transfer genet materi pathogen abil micro organ diseas inflict damag host pathogen diseas combin toxic invas ii toxic colonis abil invas pathogen diseas result abnorm reaction host defenc system symbiosi type interact organ organ live intim associ favour organ viabl micro organ micro organ capabl replic transfer genet materi viabl residu residu capabl replic transfer genet materi viroid class infecti agent consist small strand rna protein rna code protein translat replic host cell enzym viroid plant diseas virul measur degre diseas produc abil micro organ sever diseas produc measur dosag inoculum size requir specif degre pathogen measur experiment median lethal dose ld median infect dose id evalu object evalu identifi assess scientif basi experi reach case case basi potenti advers effect human anim health environ microbi plant protect product evalu carri order identifi risk manag measur identifi recommend suitabl measur due abil micro organ replic clear differ chemic micro organ plant protect product hazard aris necessarili natur present chemic relat capac micro organ persist multipli environ micro organ consist wide rang organ uniqu characterist differ micro organ account evalu micro organ plant protect product ideal function cell factori work directli spot target organ harm understand mode action crucial step evalu process toxic studi biolog properti micro organ relationship plant anim human pathogen mode action analyt method basi inform metabolit consid possibl relev potenti exposur metabolit assess order decid relev gener principl regard current scientif technic knowledg member state evalu inform provid accord requir annex iib iiib identifi hazard aris assess signific make judgement risk human anim environ assess perform term efficaci phytotox pathogen plant protect product authoris sought qualiti methodolog test standardis test method evalu characterist method assess relev repres sensit specif reproduc interlaboratori valid predict interpret result evalu member state consider element uncertainti inform obtain evalu order ensur chanc fail detect advers effect underestim import reduc minimum decis make process examin identifi critic decis point item data uncertainti lead fals classif risk evalu made base data estim reflect realist condit plant protect product repeat evalu take account potenti uncertainti critic data rang condit occur result realist worst case approach determin initi evalu significantli member state evalu microbi plant protect product applic authoris made member state inform evalu micro organ account member state account fact formul impact characterist plant protect product compar micro organ evalu applic grant authoris member state propos practic condit purpos dose manner frequenc time applic natur composit plant protect product member state account principl integr pest control evalu member state agricultur plant health environment includ climat condit area specif principl section provid calcul model evalu plant protect product model make estim relev process involv take account realist paramet assumpt submit evalu refer point reliabl valid measur carri circumst relev model relev condit area support detail indic model calcul estim provid explan input model detail deriv data requir annex iib iiib guidanc inform submit procedur prepar evalu dossier guidanc respect specif principl member state implement principl evalu data inform submit support applic prejudic gener principl prescrib section ident ident micro organ plant protect product ident micro organ establish ensur data provid check ident micro organ strain level plant protect product ident micro organ evalu strain level micro organ mutant genet modifi organ specif differ strain speci record occurr rest stage record deposit strain internation recognis cultur collect check ident plant protect product member state evalu detail quantit qualit inform provid composit plant protect product micro organ relev metabolit toxin residu growth medium formul microbi contamin present biolog physic chemic technic properti biolog properti micro organ plant protect product origin strain relev natur habitat includ indic natur background level life cycl possibl surviv colonis reproduct dispers evalu prolifer indigen micro organ short growth period level continu background micro organ abil micro organ adapt environ evalu member state account principl depend condit avail substrat growth metabol micro organ switch express phenotyp trait microbi strain adapt environ surviv multipli adapt strain adapt strain select advantag form major popul number gener rapid multipl micro organ lead higher frequenc mutat mutat promot surviv environ mutant strain domin properti virus chang rapidli includ virul inform genet stabil micro organ environment condit propos evalu inform micro organ capac transfer genet materi organ inform stabil encod trait mode action micro organ evalu detail role metabolit toxin mode action evalu identifi minim effect concentr activ metabolit toxin establish inform mode action valuabl tool identifi potenti risk aspect consid evalu antibiosi induct plant resist interfer virul pathogen target organ endophyt growth root colonis competit ecolog nich nutrient habitat parasitis invertebr pathogen order evalu effect target organ inform micro organ host specif evalu take account characterist properti abil micro organ pathogen target organ human anim target organ assess relationship plant anim human pathogen speci genu activ contamin micro organ assess pathogen virul strongli relat host speci determin bodi temperatur physiolog environ host condit health condit immun statu multipl human depend abil micro organ grow bodi temperatur host micro organ grow metabol activ temperatur human bodi temperatur pathogen human rout entri micro organ host oral inhal skin wound critic factor microbi speci diseas entri skin damag oral rout micro organ produc antibiosi substanc normal interfer microbi commun resist antimicrobi agent import human veterinari medicin assess possibl transfer gene code resist antimicrobi agent evalu physic chemic technic properti plant protect product depend natur micro organ formul type technic properti plant protect product evalu shelf life storag stabil prepar evalu take account composit growth micro organ contamin micro organ product metabolit toxin member state evalu physic chemic properti plant protect product retent characterist storag consider suitabl food agricultur organis unit nation fao specif exist physic chemic properti address specif suitabl fao specif exist relev physic chemic properti formul refer manual develop fao world health organis specif pesticid propos label claim includ requir recommend prepar plant protect product adjuv tank mix propos label includ indic compat prepar plant protect product tank mix plant protect product adjuv physic chemic compat tank mix biolog compat demonstr tank mixtur shown plant protect product mixtur perform expect antagon occur inform qualiti control product micro organ plant protect product qualiti assur criteria propos product micro organ evalu evalu criteria relat process control good manufactur practic oper practic process flow clean practic microbi monitor hygien condit account ensur good qualiti micro organ qualiti stabil puriti micro organ address qualiti control system qualiti control plant protect product qualiti assur criteria propos evalu plant protect product metabolit toxin produc growth residu growth medium evalu possibl occurr contamin micro organ evalu efficaci propos concern control protect organ member state evalu possibl organ harm agricultur plant health environment includ climat condit area propos member state evalu signific damag loss inconveni occur agricultur plant health environment includ climat condit area propos plant protect product member state evalu efficaci data provid annex iiib plant protect product regard degre control extent effect desir regard relev experiment condit choic crop cultivar agricultur environment includ climat condit accept efficaci data inform time applic presenc densiti harm organ develop stage crop organ amount microbi plant protect product requir label amount adjuv ad frequenc time applic type applic equip special clean measur applic equip member state evalu perform plant protect product rang agricultur plant health environment includ climat condit encount practic area propos effect integr control includ evalu consider paid level consist durat effect sought relat dose comparison suitabl refer product product exist untreat control relev effect yield reduct loss storag term quantiti qualiti comparison suitabl refer product product exist untreat control suitabl refer product exist member state evalu perform plant protect product determin consist defin benefit agricultur plant health environment includ climat condit encount practic area propos member state evalu degre advers effect treat crop plant protect product propos condit comparison relev suitabl refer product product exist untreat control evalu consider inform efficaci data ii relev inform plant protect product natur plant protect product dose method applic number time applic incompat crop treatment iii relev inform micro organ includ biolog properti mode action surviv host specif evalu includ natur frequenc level durat observ phytotox phytopathogen effect agricultur plant health environment includ climat condit affect ii differ main cultivar regard sensit phytotox phytopathogen effect iii part treat crop plant product phytotox phytopathogen effect observ iv advers impact yield treat crop plant product term quantiti qualiti advers impact treat plant plant product propag term viabil germin sprout root establish vi micro organ dissemin advers impact adjac crop plant protect product label includ requir plant protect product plant protect product adjuv tank mix member state make evalu refer point relat inform suppli tank mix plant protect product label includ recommend plant protect product plant protect product adjuv tank mix member state evalu appropri mix condit data micro organ signific relev metabolit toxin degrad reaction product formul persist soil plant substanc signific quantiti plant protect product propos condit member state evalu degre advers effect subsequ crop propos plant protect product intend effect vertebr member state evalu mechan effect obtain observ effect behaviour health target anim intend effect kill target anim evalu time obtain death anim condit death occur relev inform provid annex iib result evalu thereof includ toxicolog studi relev inform plant protect product provid annex iiib includ toxicolog studi efficaci data identif detect quantif method member state evalu analyt method propos post registr control monitor purpos viabl viabl compon formul residu treat crop suffici valid requir pre authoris method post authoris monitor method method consid suitabl post authoris monitor identifi analyt method plant protect product viabl compon member state evalu analyt method propos identifi quantifi toxicolog ecotoxicolog environment signific viabl compon result micro organ present impur formul includ eventu result breakdown reaction product thereof specif linear propos method precis repeat propos method import interfer accuraci propos method concentr limit quantif propos method viabl compon member state evalu method propos quantifi identifi specif strain concern method discrimin strain close relat strain specif propos method precis repeat propos method import interfer quantifi propos method analyt method determin residu viabl residu member state evalu analyt method propos identifi quantifi toxicolog ecotoxicolog environment signific viabl residu result micro organ includ eventu result breakdown reaction product thereof evalu consider inform analyt method provid annex iib iiib result evalu thereof inform account specif linear propos method precis repeat propos method reproduc independ laboratori valid propos method import interfer accuraci propos method concentr limit quantif propos method viabl residu member state evalu method propos identifi specif strain concern method discrimin strain close relat strain evalu consider inform analyt method provid annex iib iiib result evalu thereof inform account specif propos method precis repeat propos method import interfer quantifi propos method impact human anim health impact human anim health evalu member state account principl due abil micro organ replic clear differ chemic micro organ plant protect product hazard aris necessarili natur present chemic relat capac micro organ persist multipli environ pathogen micro organ human target anim infect micro organ abil micro organ colonis toxic metabolit toxin toxic residu growth medium contamin formul import endpoint assess advers effect aris plant protect product colonis infect toxic compris complex set interact micro organ host endpoint resolv easili independ endpoint combin endpoint import aspect micro organ assess abil persist multipli host indic colonis infect abil produc advers advers effect host indic infect pathogen toxic complex biolog issu account evalu hazard risk present plant protect product human anim assess pathogen infect potenti exposur deem low risk assess purpos acut toxic studi includ dose high dose expect exposur practic condit effect human anim health aris plant protect product member state evalu oper exposur micro organ toxicolog relev compound plant protect product metabolit toxin residu growth medium contamin formul occur propos condit includ dose applic method climat condit realist data exposur level data suitabl valid calcul model european harmonis gener exposur databas plant protect product evalu consider inform medic data toxic infect pathogen studi provid annex iib result evalu thereof tier test permit evalu made micro organ respect abil persist grow host abil effect reaction host paramet absenc abil persist multipli host absenc abil produc advers advers effect host includ fast complet clearanc bodi activ immun system histopatholog replic temperatur mammalian bodi temperatur paramet case assess acut studi exist human data assess repeat dose studi evalu base relev paramet tier test lead assess effect occup exposur take account intens durat exposur includ exposur due repeat practic toxic metabolit toxin assess demonstr test anim expos metabolit toxin ii relev inform micro organ metabolit toxin residu growth medium contamin formul plant protect product biolog physic chemic properti surviv micro organ bodi temperatur human anim ecolog nich behaviour micro organ metabolit toxin applic iii toxicolog studi provid annex iiib iv relev inform provid annex iiib composit prepar natur prepar size design type packag field natur crop target method applic includ handl load mix plant protect product exposur reduct measur recommend protect cloth recommend maximum applic rate minimum sprai applic volum state label number time applic basi inform mention end point establish singl repeat oper exposur intend persist growth micro organ host advers effect observ observ expect effect contamin includ contamin micro organ observ expect effect relev metabolit toxin indic colonis host advers effect indic toxic infect observ take account exposur scenario acut repeat exposur test evalu made type applic method applic equip propos plant protect product type size contain take account mix load oper applic plant protect product clean routin mainten applic equip relev authoris plant protect product area envisag activ substanc give rise residu account account replic micro organ expect exposur assess highli specul absenc presenc potenti colonis possibl effect oper test dose level provid annex iib iiib assess regard measur estim level human exposur risk assess prefer quantit includ consider mode action biolog physic chemic properti micro organ substanc formul member state examin inform relat natur characterist packag propos refer aspect type packag dimens capac size open type closur strength leakproof resist normal transport handl resist compat content member state examin natur characterist protect cloth equip propos refer aspect obtain suitabl effect eas wear take account physic stress climat condit resist compat plant protect product member state evalu possibl exposur human worker expos applic plant protect product enter worker bystand anim micro organ toxicolog relev compound plant protect product propos condit evalu consider inform medic data toxic infect pathogen studi provid annex iib result evalu thereof tier test permit evalu made micro organ respect abil persist grow host abil effect reaction host paramet absenc abil persist multipli host absenc abil produc advers advers effect host includ rapid complet clearanc bodi activ immun system histopatholog inabl replic mammalian bodi temperatur paramet case assess acut studi exist human data assess repeat dose studi evalu base relev paramet tier test lead assess effect occup exposur take account intens durat exposur includ exposur due repeat practic toxic metabolit toxin assess demonstr test anim expos metabolit toxin relev inform micro organ metabolit toxin residu growth medium contamin formul plant protect product biolog physic chemic properti surviv micro organ bodi temperatur human anim ecolog nich behaviour micro organ metabolit toxin applic toxicolog studi provid annex iiib relev inform plant protect product provid annex iiib entri period wait period precaut protect human anim method applic sprai maximum applic rate minimum sprai applic volum composit prepar excess remain plant plant product treatment take account influenc factor temperatur uv light ph presenc substanc activ worker expos effect human anim health aris residu evalu viabl viabl residu address separ virus viroid consid viabl residu capabl transfer genet materi strictli speak live viabl residu member state evalu possibl exposur human anim viabl residu degrad product food chain due occurr residu edibl part treat crop inform account stage develop micro organ viabl residu produc develop stage life cycl micro organ typic environment condit attent paid assess likelihood surviv multipl micro organ crop food feed consequ likelihood product viabl residu stabil relev viabl residu includ effect factor temperatur uv light ph presenc substanc experiment studi show relev viabl residu transloc plant data propos good agricultur practic includ number time applic maximum applic rate minimum sprai applic volum propos pre harvest interv envisag withhold period storag period case post harvest addit data applic provid annex iiib relev authoris plant protect product area envisag residu natur occurr viabl residu edibl plant part consequ natur occur micro organ member state evalu toxic viabl residu degrad product regard specif inform provid accord annex iib iiib viabl residu degrad product consid toxicolog relev human anim exposur consid neglig actual level edibl part treat crop determin take consider analyt method viabl residu growth curv micro organ optim condit product format viabl residu relev moment anticip harvest time viabl residu member state evalu possibl exposur human anim viabl residu food chain due occurr residu edibl part treat crop inform account likelihood surviv persist multipl micro organ crop food feed develop stage life cycl micro organ address inform ecolog nich inform fate behaviour part environ natur occurr micro organ relat micro organ data propos good agricultur practic includ number time applic maximum applic rate minimum sprai applic volum propos pre harvest interv envisag withhold period storag period case post harvest addit data applic provid annex iiib relev authoris plant protect product area envisag micro organ result residu member state evalu specif inform abil viabl residu persist grow host abil residu effect reaction host inform account medic data toxic infect pathogen studi provid annex iib result evalu thereof develop stage life cycl micro organ typic environment condit treat crop mode action micro organ biolog properti micro organ host specif develop stage life cycl micro organ address event viabl residu consid toxicolog relev human anim exposur consid neglig actual level edibl part treat crop determin take consider analyt method viabl residu growth curv micro organ optim condit possibl extrapol data crop fate behaviour environ biocomplex ecosystem interact microbi commun concern account inform origin properti specif micro organ residu metabolit toxin intend form basi assess environment fate behaviour mode action micro organ consider assess made fate behaviour relev metabolit produc micro organ assess made environment compart trigger basi criteria section iv annex iib assess environment fate behaviour plant protect product member state regard aspect environ includ biota potenti persist multipl micro organ assess environment compart justifi micro organ reach specif compart mobil micro organ residu metabolit toxin consid member state evalu possibl contamin ground water surfac water drink water propos condit plant protect product assess member state pai attent potenti advers effect human groundwat contamin activ substanc appli region vulner condit drink water abstract area member state evalu risk aquat compart possibl exposur aquat organ establish micro organ give rise risk potenti multipl establish environ long last perman impact microbi commun predat evalu consider inform biolog properti micro organ surviv micro organ environ ecolog nich natur background level micro organ indigen inform fate behaviour part environ relev inform potenti interfer analyt system control qualiti drink water provid council direct ec novemb qualiti water intend human consumpt relev authoris plant protect product area envisag activ substanc rise residu member state evalu possibl exposur organ atmospher plant protect product propos condit possibl exist evalu risk atmospher transport short rang long rang micro organ atmospher account member state evalu possibl exposur organ terrestri compart plant protect product propos condit possibl exist evalu risk aris terrestri compart micro organ give rise risk potenti multipl establish environ long last perman impact microbi commun predat evalu consider inform biolog properti micro organ surviv micro organ environ ecolog nich natur background level micro organ indigen inform fate behaviour part environ relev authoris plant protect product area envisag activ substanc rise residu effect exposur target organ inform ecolog micro organ effect environ assess exposur level effect relev metabolit toxin assess environment risk plant protect product take account normal level exposur micro organ environ bodi organ member state evalu possibl exposur target organ propos condit possibl exist evalu risk aris target organ concern applic assess infect pathogen justifi target organ expos assess possibl exposur inform consider surviv micro organ respect compart ecolog nich natur background level micro organ indigen inform fate behaviour part environ relev authoris plant protect product area envisag activ substanc give rise residu member state evalu possibl exposur effect terrestri wildlif domest bird mammal terrestri vertebr micro organ give rise risk potenti infect multipli avian mammalian host system identifi risk chang due formul plant protect product assess take account inform micro organ mode action biolog properti studi mammalian toxic pathogen infect studi avian toxic pathogen infect plant protect product give rise toxic effect due action toxin formul assess effect inform consider studi mammalian toxic studi avian toxic inform fate behaviour part environ mortal sign intox observ test evalu includ calcul toxic exposur ratio base quotient ld estim exposur express mg kg bodi weight member state evalu possibl exposur effect aquat organ micro organ give rise risk potenti infect multipli aquat organ identifi risk chang due formul plant protect product assess take account inform micro organ mode action biolog properti studi toxic pathogen infect plant protect product give rise toxic effect due action toxin formul assess effect inform consider studi toxic aquat organ inform fate behaviour part environ mortal sign intox observ test evalu includ calcul toxic exposur ratio base quotient ec noec estim exposur member state evalu possibl exposur effect bee micro organ give rise risk potenti infect multipli bee identifi risk chang due formul plant protect product assess take account inform micro organ mode action biolog properti studi toxic pathogen infect plant protect product give rise toxic effect due action toxin formul assess effect inform consider studi toxic bee inform fate behaviour part environ mortal sign intox observ test evalu includ calcul hazard quotient base quotient dose ha ld μg bee member state evalu possibl exposur effect arthropod bee micro organ give rise risk potenti infect multipli arthropod bee identifi risk chang due formul plant protect product assess take account inform micro organ mode action biolog properti studi toxic pathogen infect honeybe arthropod plant protect product give rise toxic effect due action toxin formul assess effect inform consider studi toxic arthropod inform fate behaviour part environ data biolog primari screen mortal sign intox observ test evalu includ calcul toxic exposur ratio base quotient er effect rate estim exposur member state evalu possibl exposur effect earthworm micro organ give rise risk potenti infect multipli earthworm identifi risk chang due formul plant protect product assess take account inform micro organ mode action biolog properti studi earthworm toxic pathogen infect plant protect product give rise toxic effect due action toxin formul assess effect inform consider studi earthworm toxic inform fate behaviour part environ mortal sign intox observ test evalu includ calcul toxic exposur ratio base quotient lc estim exposur express mg kg dry weight soil member state evalu possibl exposur effect soil micro organ micro organ give rise risk potenti interfer nitrogen carbon mineralis soil identifi risk chang due formul plant protect product assess take account inform micro organ mode action biolog properti experiment data requir justifi proper risk assess perform inform member state evalu impact exot indigen micro organ target micro organ predat plant protect product propos condit experiment data requir justifi proper risk assess perform inform plant protect product give rise toxic effect due action toxin formul assess effect inform consider inform fate behaviour part environ inform biolog primari screen conclus propos member state draw conclus inform test measur limit risk aris member state justifi propos classif label plant protect product decis make gener principl member state impos condit restrict authoris grant natur sever condit restrict select basi natur extent expect advantag risk aris member state ensur decis grant authoris account agricultur plant health environment includ climat condit area envisag consider result specif condit restrict authoris grant area member state question member state ensur authoris amount term rate number applic minimum achiev desir effect higher amount result unaccept risk human anim health environ authoris amount differenti agricultur plant health environment includ climat condit area authoris grant rate number applic give rise undesir effect develop resist member state ensur decis respect principl integr pest control plant protect product intend condit principl reli evalu base data limit number repres speci member state ensur plant protect product long term repercuss abund divers target speci issu authoris member state ensur label plant protect product fulfil requir articl direct inform protect user requir commun legisl worker protect specifi condit restrict plant protect product refer point authoris mention particular articl direct articl direct ec european parliament council approxim law regul administr provis member state relat classif packag label danger prepar issu authoris member state ensur propos packag accord provis direct ec ensur procedur destruct plant protect product procedur neutralis advers effect plant protect product accident dispers procedur decontamin destruct packag accord relev regulatori provis authoris grant requir refer point satisfi specif decis make requir refer point fulli satisfi authoris grant advantag plant protect product propos condit outweigh advers effect restrict plant protect product relat complianc requir refer point mention label advantag term advantag compat integr control measur organ farm facilit strategi minimis risk develop resist reduc risk oper consum reduc contamin environ reduc impact target speci authoris grant requir provid annex member state virtu articl defin prefer close cooper applic measur improv perform plant protect product defin close cooper applic measur reduc exposur occur plant protect product member state inform applic measur identifi invit applic provid supplementari data inform demonstr perform potenti risk aris chang condit member state ensur practic micro organ consid authoris applic account relev knowledg inform literatur time submiss micro organ genet modifi defin direct ec authoris grant evalu conduct accord direct ec submit requir articl direct relev decis compet author accord direct ec provid accord articl direct authoris grant plant protect product genet modifi organ authoris grant provis direct ec part organ releas environ authoris grant relev metabolit toxin expect concern human health environ form micro organ microbi contamin present plant protect product shown amount present accept level propos member state ensur adequ qualiti control measur appli ensur ident micro organ content plant protect product measur includ hazard analysi critic control point haccp system equival system specif principl specif principl appli prejudic gener principl refer section ident authoris grant member state ensur micro organ concern deposit internation recognis cultur collect access number micro organ identifi name speci level characteris strain level inform micro organ wild type spontan induc mutant genet modifi organ biolog technic properti suffici inform permit assess minimum maximum content micro organ materi manufactur plant protect product plant protect product content compon formul plant protect product contamin micro organ deriv product process extent defin member state ensur level contamin organ control accept level addit physic natur state plant protect product prefer quot catalogu pesticid formul type intern code system croplif intern technic monograph edit quot authoris grant stage develop microbi plant protect product appar basi build resist transfer resist mechan interfer effect anti microbi agent human anim medicin inform authoris grant full inform provid continu qualiti control product method product process plant protect product occurr spontan major characterist micro organ absenc presenc contamin organ consid qualiti assur criteria product techniqu ensur uniform plant protect product extent efficaci perform authoris grant propos includ recommend control protect organ consid harm basi experi acquir scientif evid normal agricultur plant health environment includ climat condit area propos intend effect consid benefici condit level consist durat control protect intend effect similar result suitabl refer product suitabl refer product exist plant protect product shown give defin benefit term level consist durat control protect intend effect agricultur plant health environment includ climat condit area propos relev yield respons plant protect product reduct loss storag quantit qualit similar result suitabl refer product suitabl refer product exist plant protect product shown give consist defin quantit qualit benefit term yield respons reduct loss storag agricultur plant health environment includ climat condit area propos conclus perform prepar valid area member state authoris condit propos propos label specifi prepar intend circumst light infest soil type grow condit propos label claim includ requir prepar plant protect product adjuv tank mix mixtur achiev desir effect compli principl refer point propos label claim includ recommend prepar plant protect product adjuv tank mix member state accept recommend justifi evid develop resist pathogen plant protect product member state decid submit resist manag strategi address adequ suffici plant protect product viabl micro organ authoris control vertebr speci intend effect vertebr control obtain unnecessari suffer unnecessari pain anim absenc unaccept effect plant plant product relev phytotox effect treat plant plant product propos label limit reduct yield harvest due phytotox effect obtain plant protect product reduct compens advantag enhanc qualiti treat plant plant product unaccept advers effect qualiti treat plant plant product case advers effect process propos label claim prepar appli crop process purpos unaccept advers effect treat plant plant product propag reproduct effect viabil germin sprout root establish propos label claim prepar appli plant plant product propag reproduct unaccept impact succeed crop propos label claim crop affect grown treat crop unaccept impact adjac crop propos label claim prepar appli sensit adjac crop present propos label claim includ requir prepar plant protect product adjuv tank mix mixtur compli principl refer point propos instruct clean applic equip practic effect appli eas ensur remov residu trace plant protect product subsequ damag identif detect quantif method method propos reflect latest techniqu method post authoris monitor involv commonli reagent equip authoris grant adequ method suffici qualiti identifi quantifi micro organ viabl compon toxin impur formul plant protect product case plant protect product micro organ recommend method capabl identifi determin content authoris grant adequ method post registr control monitor viabl viabl residu method analysi plant plant product foodstuff plant anim origin feedingstuff toxicolog relev residu occur residu consid relev maximum residu level mrl wait entri safeti period precaut requir soil water air bodi tissu toxicolog ecotoxicolog environment relev residu occur impact human anim health effect human anim health aris plant protect product authoris grant basi inform provid dossier appear micro organ pathogen human target anim propos condit authoris grant micro organ plant protect product micro organ recommend condit includ realist worst case scenario colonis advers effect human anim make decis authoris microbi plant protect product member state effect human popul profession user profession user human expos directli indirectli environ work anim micro organ regard potenti sensitis establish mean relev inform risk sensitis take account immuno compromis sensit individu authoris grant protect cloth suitabl glove worn plant protect product micro organ inhal propos condit requir addit item protect cloth equip propos condit requir item protect cloth authoris grant item effect accord relev commun provis readili obtain user feasibl condit plant protect product take account climat condit authoris grant transfer genet materi micro organ organ lead advers effect human anim health includ resist therapeut substanc plant protect product properti mishandl misus lead high degre risk subject restrict restrict size packag formul type distribut manner plant protect product classifi toxic authoris profession user wait entri safeti period precaut establish colonis advers effect bystand worker expos applic plant protect product expect wait entri safeti period precaut establish colonis advers effect anim expect wait entri period precaut ensur colonis advers effect expect realist special precautionari measur prescrib condit authoris complianc council direct ec april protect health safeti worker risk relat chemic agent work direct ec european parliament council septemb protect worker risk relat exposur biolog agent work experiment data inform relev recognit symptom infect pathogen effect aid therapeut measur provid consid condit authoris complianc direct ec european parliament council april protect worker risk relat exposur carcinogen mutagen work condit authoris complianc council direct eec novemb minimum health safeti requir worker person protect equip workplac effect human anim health aris residu authoris grant suffici inform plant protect product micro organ decid harm effect human anim health aris exposur micro organ residu trace metabolit toxin remain plant plant product authoris grant viabl residu viabl residu occur reflect minimum quantiti plant protect product achiev adequ control good agricultur practic appli manner includ pre harvest interv withhold period storag period viabl residu toxin harvest slaughter storag reduc minimum fate behaviour environ authoris grant inform unaccept advers environment effect due fate behaviour plant protect product environ authoris grant contamin ground water surfac water drink water expect result plant protect product propos condit interfer analyt system control qualiti drink water provid direct ec authoris grant contamin groundwat expect result plant protect product propos condit contraven exce whichev lower paramet maximum permiss concentr laid direct ec paramet maximum permiss concentr laid compon plant protect product relev metabolit toxin accord direct ec european parliament council octob establish framework commun action field water polici paramet micro organ maximum concentr laid commiss compon plant protect product relev metabolit toxin includ micro organ annex basi data toxicolog data concentr laid concentr accept daili intak adi laid micro organ includ annex scientif demonstr relev field condit lower paramet concentr contraven exceed authoris grant contamin surfac water expect result plant protect product propos condit exce surfac water area envisag intend extract drink water paramet valu establish accord council direct eec june qualiti requir surfac water intend abstract drink water member state exce paramet valu compon plant protect product relev metabolit toxin establish accord direct ec impact deem unaccept target speci includ anim relev requir provid point propos instruct plant protect product includ procedur clean applic equip likelihood accident contamin surfac water reduc minimum authoris grant transfer genet materi micro organ organ lead unaccept effect environ authoris grant suffici inform persist competit micro organ relev secondari metabolit toxin crop environment condit prevail intend authoris grant expect micro organ relev metabolit toxin persist environ concentr consider higher natur background level take account repeat applic year robust risk assess risk accumul plateau concentr accept effect target organ member state ensur inform suffici permit decis unaccept effect target speci flora fauna due exposur plant protect product micro organ intend member state pai special attent effect benefici organ biolog control organ plai import role integr control possibl bird target terrestri vertebr expos authoris grant micro organ pathogen bird target terrestri vertebr case toxic effect due compon plant protect product relev metabolit toxin toxic exposur ratio basi acut ld long term toxic exposur ratio establish risk assess field condit unaccept effect occur directli indirectli plant protect product propos condit possibl aquat organ expos authoris grant micro organ pathogen aquat organ case toxic effect due compon plant protect product relev metabolit toxin toxic exposur ratio case acut toxic ec daphnia fish long term chronic toxic alga ec daphnia noec fish noec establish risk assess field condit unaccept impact viabil expos speci occur directli indirectli plant protect product propos condit possibl bee expos authoris grant micro organ pathogen bee case toxic effect due compon plant protect product relev metabolit toxin hazard quotient oral contact exposur honeybe greater establish risk assess field condit unaccept effect honeybe larva honeybe behaviour coloni surviv develop plant protect product propos condit possibl arthropod bee expos authoris grant micro organ pathogen arthropod bee case toxic effect due compon plant protect product relev metabolit toxin establish risk assess field condit unaccept impact organ plant protect product propos condit claim select propos integr pest manag system substanti data possibl earthworm expos authoris grant micro organ pathogen earthworm case toxic effect due compon plant protect product relev metabolit toxin acut toxic exposur ratio long term toxic exposur ratio establish risk assess field condit earthworm popul risk plant protect product propos condit possibl target soil micro organ expos authoris grant nitrogen carbon mineralis process laboratori studi affect dai establish risk assess field condit unaccept impact microbi commun plant protect product propos condit take account abil micro organ multipli oj direct amend regul ec oj definit quot genet modifi quot direct ec oj direct amend regul ec european parliament council oj oj direct amend direct ec oj oj oj oj oj oj direct amend decis ec oj direct repeal direct ec oj