commiss direct ec march amend council direct eec place plant protect product market text eea relev commiss european commun regard treati establish european commun regard council direct eec juli place plant protect product market amend commiss direct ec articl thereof annex ii iii direct eec set requir dossier submit applic inclus activ substanc annex direct author plant protect product annex ii iii direct eec applic precis detail requir inform circumst condit technic protocol data gener provis introduc order permit applic prepar file introduc precis regard data requir ecotoxicolog studi activ substanc provid part point annex ii direct eec introduc precis regard data requir ecotoxicolog studi plant protect product provid part point annex iii direct eec measur provid direct accord opinion stand committe plant health adopt direct articl direct eec amend part annex ii point ecotoxicolog studi activ substanc replac annex hereto part annex iii point ecotoxicolog studi summari evalu point replac annex ii hereto articl member state bring forc law regul administr provis compli direct march immedi inform commiss thereof member state adopt measur refer direct accompani refer time offici public procedur refer adopt member state articl direct enter forc april articl direct address member state brussel march commiss ritt bjerregaard member commiss oj oj annex ecotoxicolog studi introduct inform provid prepar activ substanc suffici permit assess impact target speci flora fauna risk exposur activ substanc metabolit degrad reaction product environment signific impact result singl prolong repeat exposur revers irrevers ii inform provid activ substanc relev inform provid prepar suffici decid activ substanc includ annex condit restrict inclus annex permit evalu short long term risk target speci popul commun process classifi activ substanc hazard precaut protect target speci hazard symbol indic danger relev risk safeti phrase protect environ mention packag contain iii report potenti advers effect found routin ecotoxicolog investig undertak report requir compet author addit studi investig probabl mechan involv assess signific effect biolog data inform relev assess ecotoxicolog profil activ substanc report iv inform fate behaviour environ gener submit accord point residu level plant gener submit accord point central assess impact target speci inform natur prepar manner defin natur extent potenti exposur toxicokinet toxicolog studi inform submit accord point provid essenti inform toxic vertebr speci mechan involv relev test design data analys statist method full detail statist analysi report point estim confid interv exact valu state signific signific test substanc vi detail descript specif materi provid point provid test activ substanc materi specif manufactur prepar author radiolabel materi vii studi conduct activ substanc produc laboratori pilot plant product system studi repeat activ substanc manufactur justifi test materi essenti purpos ecotoxicolog test assess case uncertainti bridg studi submit serv basi decis repetit studi viii case studi dose extend period dose prefer singl batch activ substanc stabil permit studi impli dose relationship dose advers effect report ix feed studi averag achiev dose report includ dose mg kg bodi weight dose diet util test compound distribut uniformli diet conduct separ studi metabolit degrad reaction product product constitut relev risk target organ effect evalu result relat activ substanc studi perform inform point account test organ xi order facilit assess signific test result obtain includ estim intrins toxic factor affect toxic strain record origin relev speci toxic test effect bird acut oral toxic aim test test provid ld valu lethal threshold dose time cours respons recoveri noel includ relev gross patholog find circumst requir effect activ substanc bird investig activ substanc intend sole includ prepar exclus enclos space glasshous food storag practic test condit acut oral toxic activ substanc quail speci japanes quail coturnix coturnix japonica bobwhit quail colinu virginianu mallard duck ana platyrhyncho determin highest dose test exce mg kg bodi weight test guidelin setac procedur assess environment fate ecotox pesticid short term dietari toxic aim test test provid short term dietari toxic lc valu lowest lethal concentr llc observ effect concentr noec time cours respons recoveri includ relev gross patholog find circumst requir dietari dai toxic activ substanc bird investig speci studi accord provis point report acut oral noel amp le mg kg bodi weight short term noec amp lt mg kg food test perform speci test condit speci studi quail speci mallard duck speci test relat speci test test guidelin test carri accord oecd method subchron toxic reproduct aim test test provid subchron toxic reproduct toxic activ substanc bird societi environment toxicolog chemistri setac procedur assess environment fate ecotox pesticid isbn circumst requir subchron reproduct toxic activ substanc bird investig justifi continu repeat exposur adult exposur nest site breed season occur test guidelin test carri accord oecd method effect aquat organ data test refer point submit activ substanc expect plant protect product reach surfac water propos condit data requir provis annex vi direct eec classif activ substanc data report support analyt data concentr test substanc test media acut toxic fish aim test test provid acut toxic lc detail observ effect circumst requir test carri test condit acut toxic activ substanc determin rainbow trout oncorhynchu mykiss warm water fish speci test metabolit degrad reaction product perform speci sensit speci test activ substanc test guidelin test carri accord annex commiss direct eec adapt technic progress time direct eec approxim law regul administr provis relat classif label danger substanc method chronic toxic fish circumst requir chronic toxic studi carri justifi continu repeat exposur fish occur suitabl microsom mesocosm studi expert judgment requir decid test perform activ substanc indic concern relat toxic activ substanc fish potenti exposur applic seek agreement compet author type test perform fish earli life stage toxic test bioconcentr factor bcf ec activ substanc amp lt mg fish life cycl test case bioconcentr factor greater tan elimin activ substanc depur phase dai lower substanc stabl water sediment dt amp gt dai perform chronic toxic test juvenil fish fish earli life stage toxic test fish life cycl test perform likewis perform fish earli life stage toxic test fish life cycl test perform chronic toxic test juvenil fish aim test test provid effect growth threshold level lethal effect observ effect noec detail observ effect oj test condit test conduct juvenil rainbow trout exposur dai activ substanc data effect growth behaviour gener fish earli life stage toxic test aim test test provid effect develop growth behaviour noec detail observ effect fish earli life stage test guidelin test carri accord oecd method fish life cycl test aim test test provid effect reproduct parent viabil filial gener test condit perform studi applic seek agreement compet author type condit studi perform bioconcentr fish aim test test provid steadi state bioconcentr factor uptak rate constant depur rate constant calcul test compound relev confid limit circumst requir bioconcentr potenti activ substanc metabolit degrad reaction product partit fatti tissu log pow amp ge point relev indic bioconcentr investig report justifi exposur lead bioconcentr occur test guidelin test carri accord oecd method acut toxic aquat invertebr aim test test provid hour acut toxic activ substanc express median effect concentr ec immobil highest concentr caus immobil circumst requir acut toxic determin daphnia prefer daphnia magna plant protect product activ substanc intend directli surfac water addit data report repres speci group aquat insect aqaut crustacean speci relat daphnia aquat gastropod mollusc test guidelin test carri accord direct eec method chronic toxic aquat invertebr aim test test provid ec valu effect immobil reproduct highest concentr effect martal reproduct occur noec detail observ effect circumst requir test daphnia repres aquat insect speci aquat gastropod mollusc speci carri justifi continu repeat exposur occur test condit test daphnia continu dai test guidelin test carri accord oecd method part ii effect algal growth aim test test procid ec valu growth growth rate noec valu detail observ effect circumst requir effect algal growth activ substanc report herbicid test speci taxonom group perform test guidelin test carri accord direct eec method effect sediment dwell organ aim test test measur effect surviv develop includ effect emerg adult chironomu relev ec valu noec valu circumst requir environment fate behaviour data requir point report activ substanc partit persist aquat sediment expert judgement decid acut chronic sediment toxic test requir expert judgement account effect sediment dwell invertebr compar aquat invertebr toxic ec data point predict level activ substanc sediment data annex iii point test condit perform studi applic seek agreement compet author type condit studi perform aquat plant test aquat plant perform herbicid perform studi applic seek agreement compet author type condit studi perform effect arthropod bee acut toxic aim test test provid acut oral contact ld activ substanc circumst requir potenti impact bee investig prepar activ substanc exclus situat bee expos food storag enclos space system seed dress system prepar applic soil system dip treatment transplant crop bulb wound seal heal treatment rodenticid bait glasshous pollin test guidelin test carri accord eppo guidelin bee brood feed test aim test test provid suffici inform evalu risk plant protect product honeybe larva circumst requir test carri activ substanc act insect growth regul justifi bee brood expos test guidelin test carri accord icpbr method oomen de riujter van der steen method honeybe brood feed test insect growth regul insecticid eppo bulletin volum pp arethropod aim test test provid suffici inform evalu toxic mortal subleth effect activ substanc select arthropod speci circumst requir effect target terrestri arthropod predat parasitoid harm organ investig inform obtain speci potenti toxic target speci inhabit environ inform requir activ substanc prepar activ substanc exclus situat target arthropod expos food storag enclos space wound seal heal treatment rodenticid bait test condit test perform initi laboratori artifici substrat glass plate quartz sand advers effect predict studi case realist substrat sensit standard speci parasitoid predatori mite aphidiu rhopalosiphi typhlodromu pyri test addit addit speci test relev intend substanc repres major function group ground dwell predat foliag dwell predat effect observ speci relev propos product test carri extend laboratori semi field level select relev test speci follow propos outlin setac guidanc document regulatori test procedur pesticid target arthropod test conduct rate equival highest rate field applic recommend test guidelin relev test guidelin satisfi requir test includ setac guidanc document regulatori test procedur pesticid target arthropod effect earthworm acut toxic aim test test provid lc activ substanc earthworm highest concentr caus mortal lowest concentr caus mortal includ observ morpholog behaviour effect workshop european standard characterist benefici regulatori test escort march isbn circumst requir effect earthworm investig prepar activ substanc appli soil contamin soil test guidelin test carri accord commiss direct eec adapt technic progress ninth time council direct eec approxim law regul administr provis relat classif packag label danger substanc part toxic earthworm artifici soil test subleth effect aim test test provid noec effect growth reproduct behaviour circumst requir basi propos manner prepar activ substanc basi fate behaviour soil dt amp gt dai continu repeat exposur earthworm activ substanc signific quantiti metabolit degrad reaction product anticip expert judgement requir decid subleth test test condit test carri eisenia foetida effect soil target micro organ aim test test provid suffici data evalu impact activ substanc soil microbi activ term nitrogen transform carbon miner circumst requir test carri prepar activ substanc appli soil contamin soil practic condit case activ substanc intend prepar soil steril studi design measur rate recoveri treatment test condit soil freshli sampl agricultur soil site soil treat previou year substanc substanti alter divers level microbi popul present transitori manner test guidelin setac procedur assess environment fate ecotox pesticid effect target organ flora fauna believ risk summari data preliminari test assess biolog activ dose rang find posit neg provid inform respect impact target speci flora fauna provid critic assess relev potenti impact target speci effect biolog method sewag treatment effect biolog method sewag treatment report plant protect product activ substanc give rise advers effect sewag treatment plant oj annex ii ecotoxicolog studi introduct inform provid activ substanc suffici permit assess impact target speci flora fauna plant protect product propos impact result singl prolong repeat exposur revers irrevers ii inform provid plant protect product relev inform provid activ substanc suffici hazard symbol indic danger relev risk safeti phrase protect environ mention packag contain permit evalu short long term risk target speci popul commun process permit evalu special precaut protect target speci iii report potenti advers effect found routin ecotoxicolog investig undertak report addit studi investig mechan involv assess signific effect iv gener data relat impact target speci requir author plant protect product submit evalu inclus activ substanc annex inform fate behaviour environ gener submit accord point residu level plant gener submit accord point central assess impact target speci inform natur extent potenti actual exposur final pec estim adapt group organ take consider biologi sensit speci toxicolog studi inform submit accord point provid essenti inform toxic vertebr speci relev test design data analys statist method full detail statist analysi report point estim confid interv exact valu state signific signific vi studi impli dose relationship dose advers effect report vii exposur data decid studi perform data obtain accord provis annex iii point estim exposur organ relev inform plant protect product activ substanc account approach estim provid eppo council europ scheme environment risk assess relev paramet provid section appear data plant protect product toxic activ substanc toxic data plant protect product calcul relev toxic exposur ratio viii context influenc impur ecotoxicolog behaviour essenti studi submit detail descript specif materi provid point provid ix order facilit assess signific test result obtain strain relev speci toxic test oepp eppo decis make scheme environment risk assess plant protect product bulletin oepp eppo bulletin bulletin effect bird effect bird investig possibl bird expos directli indirectli rule enclos space wound heal treatment acut toxic exposur ratio tera short term dietari toxic exposur ratio terst long term dietari toxic exposur ratio terlt report tera ld mg kg bodi weight et mg kg bodi weight terst lc mg kg food et mg kg food terlt noec mg kg food et mg kg food et estim theoret exposur case pellet granul treat seed amount pellet granul seed report proport ld particl gram particl size shape pellet granul report case bait concentr bait mg kg report acut oral toxic aim test test provid ld valu lethal threshold dose time cours respons recoveri noel includ relev gross patholog find circumst requir acut oral toxic prepar report tera terst activ substanc bird result mammal test give evid significantli higher toxic prepar compar activ substanc justifi bird expos plant protect product test condit studi conduct sensit speci identifi studi provid annex ii point supervis cage field trial aim test test provid suffici data evalu natur extent risk practic condit circumst requir tera terst amp gt evid risk studi activ substanc reproduct studi test requir case expert judgement decid carri studi expert judgement account relev forag behaviour repel altern food actual residu content food persist compound veget degrad formul product treat produc amount predat food accept bait granul treat seed possibl bioconcentr tera terst amp le terlt amp le cage field trial conduct report final assess basi studi point test condit perform studi applic seek agreement compet author type condit studi perform accept bait granul treat seed bird aim test test provid suffici data evalu possibl consumpt protect product plant product treat circumst requir case seed dress pellet bait prepar granul tera amp le accept palat test conduct effect secondari poison expert judgment requir decid effect secondari poison investig effect aquat organ effect aquat speci investig possibl aquat speci expos rule tera terlt report tera acut lc mg realist worst case pecsw initi short term mg terlt chronic noec mg long term pecsw mg acut toxic fish aquat invertebr effect algal growth circumst requir principl test carri speci group aquat organ refer annex ii point fish aquat invertebr alga case plant protect product contamin water inform permit conclud group sensit test sensit speci relev group perform test perform acut toxic plant protect product predict basi data activ substanc case formul activ substanc formul solvent emulg surfact dispers fertil increas toxic comparison activ substanc intend includ direct applic water suitabl studi refer point test condit test guidelin relev provis paragraph annex ii point appli microcosm mesocom studi aim test test provid suffici data evalu essenti impact aquat organ field condit circumst requir tera amp le terlt amp le expert judgment decid microcosm mesocom studi judgment account result addit data requir provis annex ii point point test condit perform studi applic seek agreement compet author specif aim studi perform type condit studi perform studi includ highest exposur rate direct applic drift drainag run durat studi suffici permit evalu effect test guidelin guidelin includ setac guidanc document test procedur pesticid freshwat mesocosm workshop huntingdon juli freshwat field test hazard assess chemic european workshop freshwat field test ewofft residu data fish aim test test provid suffici data evalu potenti occurr residu fish circumst requir gener data bioconcentr studi fish bioconcentr observ studi perform accord annex ii point expert judgement requir decid long term microcosm mesocosm studi carri order establish maximum residu encount test guidelin setac guidanc document test procedur pesticid freshwat mesocosm workshop huntingdon juli addit studi studi refer annex ii point requir plant protect product extrapol data obtain studi activ substanc effect terrestri vertebr bird effect wild vertebr speci investig justifi terrestri vertebr bird expos directli indirectli tera terst terlt report tera ld mg kg bodi weight et mg kg bodi weight terst subchron noel mg kg food et mg kg food terlt chronic noel mg kg food et mg kg food et estim theoret exposur principl evalu sequenc assess risk speci similar bird practic perform test studi conduct accord requir annex ii point annex iii point provid requir inform aim test test provid suffici inform evalu natur extent risk terrestri vertebr bird practic condit circumst requir tera terst amp gt evid risk studi test requir case expert judgment decid carri studi expert judgment account relev forag behaviour repel altern food actual residu content food persist compound veget degrad formul product treat produc amount predat food accept bait granul treat seed possibl bioconcentr tera terst amp le terlt amp le cage field trial studi report test condit perform studi applic seek agreement compet author type condit studi perform effect secondari poison investig effect bee effect bee investig product exclus situat bee expos food storag enclos space system seed dress system prepar applic soil system dip treatment transplant crop bulb wound seal heal treatment rodenticid bait glasshous pollin hazard quotient oral contact exposur qho qhc report qho dose oral ld ìg bee qhc dose contact ld ìg bee dose maximum applic rate author sought activ substanc hectar acut oral contact toxic aim test test provid ld valu oral contact exposur circumst requir test requir product activ substanc toxic formul reliabl predict lower formul test provis annex ii point point test guidelin test carri eppo guidelin residu test aim test test provid suffici inform evalu risk forag bee residu trace plant protect product remain crop circumst requir qhc amp ge expert judgment requir decid effect residu determin evid signific residu trace remain crop affect forag bee suffici inform cage tunnel field test test condit median lethal time lt hour hour exposur residu leav ag hour determin report lt hour test requir cage test aim test test provid suffici inform evalu risk plant protect product bee surviv behaviour circumst requir qho qhc amp lt test requir signific effect observ bee brood feed test indic indirect effect delai action modif bee behaviour case cage field test carri qho qhc amp gt cage field test requir field test conduct report accord point conduct cage test cage test conduct report test condit test carri healthi bee bee treat varroacid wait week coloni test guidelin test conduct accord eppo guidelin field test aim test test provid suffici inform evalu risk plant protect product bee behaviour coloni surviv develop circumst requir field test conduct basi expert judgement take account propos manner fate behaviour activ substanc signific effect observ cage test test condit test carri healthi honeybe coloni similar natur strength bee treat varroacid wait week coloni test conduct condit repres propos special effect larval toxic long residu effect disori effect bee identifi field test requir investig specif method test guidelin test conduct accord eppo guidelin tunnel test aim test test provid suffici inform evalu impact bee result feed contamin honei dew flower circumst requir investig effect cage field trial tunnel test carri case plant protect product intend control aphid suck insect test condit test carri healthi bee bee treat varroacid wait week coloni test guidelin test carri accord eppo guidelin effect arthropod bee effect plant protect product target terrestri arthropod predat parasitoid harm organ investig inform obtain speci potenti toxic target speci inhabit environ laboratori extend laboratori semi field test aim test test provid suffici inform evalu toxic plant protect product select arthropod speci relev intend product circumst requir test requir sever toxic amp gt effect organ compar control predict relev data plant protect product exclus situat target arthropod expos food storag enclos space wound seal heal treatment rodenticid bait test requir signific effect organ comparison control report laboratori test maximum recommend dose conduct accord requir annex ii point effect test speci consid signific exce threshold valu defin eppo scheme environment risk assess speci specif threshold valu defin respect test guidelin test requir product activ substanc toxic formul reliabl predict lower formul test provis annex ii point point basi propos manner basi fate behaviour continu repeat exposur anticip signific chang propos arabl crop orchard speci relev previous test increas recommend applic rate previous test annex ii test condit signific effect observ studi perform accord requir annex ii point case chang arabl crop orchard toxic addit relev speci investig report relev speci test annex ii point mixtur formul toxic initi assess sensit speci identifi studi perform threshold valu exceed effect remain enabl comparison made significantli toxic speci relev propos test test conduct rate equival maximum rate applic author sought sequenti test approach adopt laboratori extend laboratori semi field applic season product appli recommend applic rate inform studi perform accord annex ii point basi propos manner basi fate behaviour continu repeat exposur anticip product appli time season applic dai expert judgment requir examin test requir initi laboratori test reflect propos pattern test perform laboratori semi field condit test laboratori realist substrat plant materi natur soil carri field test test guidelin relev test guidelin satisfi requir test includ setac guidanc document regulatori test procedur pesticid target arthropod field test aim test test provid suffici inform evalu risk plant protect product arthropod field condit circumst requir signific effect laboratori semi field exposur basi propos manner basi fate behaviour continu repeat exposur anticip expert judgement requir examin extens test permit accur risk assess test condit test conduct repres agricultur condit accord propos recommend result realist worst case studi toxic standard includ test test guidelin relev test guidelin satisfi requir test includ setac guidanc document regulatori test procedur pesticid target arthropod effect earthworm soil target macro organ believ risk effect earthworm impact earthworm report justifi earthworm expos directli indirectli tera terlt report tera lc mg kg realist worst case pec initi short term mg kg terlt noec mg kg long term pec mg kg acut toxic test aim test test provid lc highest concentr caus mortal lowest concentr caus mortal includ observ morpholog behaviour effect circumst requir studi requir product activ substanc toxic formul reliabl predict formul test provis annex ii point point test guidelin test conduct accord oecd method test subleth effect aim test test provid noec effect growth reproduct behaviour circumst requir studi requir product activ substanc toxic formul reliabl predict formul test provis annex ii point point increas recommend applic rate previous test test condit provis paragraph annex ii point appli field studi aim test test provid suffici data evalu effect earthworm field condit circumst requir terlt amp lt field studi determin effect practic field condit conduct report expert judgment requir decid residu content earthworm investig test condit field select reason earthworm popul test carri maximum propos applic rate toxic refer product includ test effect soil target macro organ aim test test provid suffici data evalu impact plant protect product macro organ contribut breakdown dead plant anim organ matter circumst requir test requir accord annex iii point evid dt valu dai natur manner plant protect product exposur occur data studi activ substanc perform accord provis annex ii point risk soil macrofauna earthworm soil microflora impact organ matter breakdown investig report dt valu determin field dissip studi point amp gt dai effect soil target micro organ laboratori test aim test test provid suffici data evalu impact plant protect product soil microbi activ term nitrogen transform carbon miner circumst requir dt valu determin field dissip studi point amp gt dai impact soil target micro organ investig laboratori test test requir studi perform accord provis annex ii point deviat control valu term metabol activ microbi biomass dai amp lt data relev natur properti prepar author test guidelin setac procedur assess environment fate ecotox pesticid addit test aim test test provid suffici data evalu impact plant protect product field condit microbi activ circumst requir end dai measur activ deviat control laboratori test test laboratori glass field data biolog primari screen summari form summari data preliminari test assess biolog activ dose rang find posit neg inform respect impact target speci flora fauna provid critic assess relev potenti impact target speci summari evalu point summari evalu data present point carri guidanc compet author member state format summari evalu includ detail critic assess data context relev evalu decis make criteria guidelin refer risk environ target speci aris extent qualiti reliabl data base issu address predict distribut fate environ time cours involv identifi target speci popul risk predict extent potenti exposur evalu short long term risk target speci popul commun process evalu risk fish kill fatal larg vertebr terrestri predat effect popul commun level identif precaut avoid minim contamin environ protect target speci