commiss direct ec octob 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 author plant protect product applic annex ii iii precis detail requir inform circumst condit technic protocol data gener provis introduc order permit applic prepar file introduc precis regard data requir residu treat product food feed activ substanc provid section part annex ii introduc precis regard data requir residu treat product food feed plant protect product provid section part annex iii measur provid direct accord opinion stand committe plant health adopt direct articl direct eec amend part annex ii section head residu treat product food feed replac annex hereto part annex iii section head data exposur text insert measur exposur plant protect product air breath area oper bystand worker requir measur procedur annex ii council direct eec novemb protect worker risk relat exposur chemic physic biolog agent work account oj part annex iii section head residu treat product food feed replac annex ii hereto articl member state bring forc law regul administr provis compli direct novemb immedi inform commiss thereof member state adopt measur refer direct accompani refer time offici public procedur refer adopt member state articl direct enter forc dai public offici journal european commun articl direct address member state brussel octob commiss franz fischler member commiss oj oj annex section part annex ii direct eec replac residu treat product food feed introduct inform provid provid prepar activ substanc suffici permit evalu made risk man aris residu activ substanc relev metabolit degrad reaction product remain food addit inform provid suffici permit decis made activ substanc includ annex condit restrict inclus annex ii detail descript specif materi provid section point provid iii studi perform guidanc regulatori test procedur residu plant protect product food iv relev data analyz statist method full detail statist analysi report stabil residu storag perform studi stabil residu storag provid sampl frozen gener hour sampl compound volatil labil data requir sampl extract analys dai sampl month case radio label materi studi radio label substanc carri repres substratet prefer sampl treat crop anim incur residu altern aliquot prepar control sampl spike amount chemic storag normal storag condit degrad storag signific chang storag condit store sampl prior analysi repeat studi unsatisfactori storag condit detail inform respect sampl prepar storag condit temperatur durat sampl extract submit storag stabil data sampl extract requir sampl analys hour extract metabol distribut express residu plant aim test object studi provid estim total termin residu relev portion crop harvest treatment propos identifi major compon total termin residu distribut residu relev crop part quantifi major compon residu establish effici extract procedur compon decid definit express residu circumst requir studi perform justifi residu remain plant plant product food feedingstuff guidanc develop test condit metabol studi involv crop categori crop plant protect product activ substanc question wide rang crop categori categori fruit envisag studi carri crop justifi metabol occur case envisag categori crop studi repres relev categori purpos crop consid fall categori root veget leafi crop fruit puls oilse cereal studi crop categori result rout degrad similar categori studi need expect metabol occur metabol studi account properti activ substanc intend method applic evalu result studi submit point path uptak leav root distribut residu relev part crop harvest emphasi edibl part man anim activ substanc relev metabolit crop explain inform mode action physico chemic properti activ substanc help assess trial data metabol distribut express residu livestock aim test object studi identifi major compon total termin residu edibl anim product quantifi rate degrad excret total residu anim product milk egg excreta distribut residu relev edibl anim product quantifi major compon residu show effici extract procedur compon gener data decis livestock feed studi provid point made decid definit express residu circumst requir metabol studi anim lactat rumin goat cow lai poultri requir pesticid lead signific residu livestock feed amp ge mg kg total diet receiv special case activ substanc accumul appar metabol pathwai differ significantli rat compar rumin pig studi conduct expect intak pig signific residu trial aim test object studi quantifi highest residu level treat crop harvest outload store propos good agricultur practic gap determin rate declin plant protect product deposit circumst requir studi perform plant protect product appli plant plant product food feedingstuff residu soil substrat plant extrapol adequ data crop residu trial data submit annex ii dossier plant protect product author sought moment introduct dossier inclus activ substanc annex test condit supervis trial correspond propos critic gap test condit account highest residu aris maximum number propos applic maximum envisag quantiti shortest pre harvest interv withhold period storag period remain repres realist worst case condit activ substanc suffici data gener submit confirm pattern determin hold region rang condit encount region concern recommend establish supervis trial programm factor climat differ exist product area differ product method outdoor versu glasshous season product type formul account gener compar set condit trial carri minimum grow season except fulli justifi precis number trial difficult determin advanc preliminari evalu trial result minimum data requir appli compar establish product area climat method grow season product assum variabl climat compar minimum trial repres propos grow area requir major crop minor crop trial repres propos grow area requir due inher higher level homogen residu aris post harvest treatment protect crop trial grow season accept post harvest treatment principl minimum trial requir carri prefer locat cultivar set trial carri applic method store type worst case residu situat identifi number studi grow season perform reduc justifi residu level plant plant product lower limit determin signific part consum crop present time applic half supervis residu trial report includ data show effect time level residu present residu declin studi justifi consum crop affect applic plant protect product propos condit livestock feed studi aim test object studi determin residu product anim origin result residu feedingstuff fodder crop circumst requir feed studi requir signific residu amp ge mg kg total diet receiv special case activ substanc accumul occur crop part crop trim wast fed anim metabol studi signific residu mg kg limit determin higher mg kg occur edibl anim tissu take account residu level potenti feedingstuff obtain dose rate separ feed studi lactat rumin lai poultri submit appear metabol studi submit accord provis point metabol pathwai differ significantli pig compar rumin pig feed studi conduct expect intak pig signific test condit gener feed administ dosag expect residu level time time expect residu level set dose theoret feed ration compil effect industri process household prepar circumst requir decis carri process studi depend import process product human anim diet level residu plant plant product process physico chemic properti activ substanc relev metabolit possibl degrad product toxicolog signific found process plant plant product process studi signific analyt determin residu occur plant plant product process total theoret maximum daili intak tmdi adi addit process studi requir plant plant product eaten raw ined portion citru banana kiwi fruit data distribut residu peel pulp requir quot signific residu quot gener refer residu mg kg pesticid concern high acut toxic low adi consider conduct process studi determin residu mg kg studi effect natur residu requir simpl physic oper involv chang temperatur plant plant product involv wash trim press effect natur residu aim test object studi establish breakdown reaction product aris residu raw product process requir separ risk assess test condit depend level chemic natur residu raw commod set repres hydrolysi situat simul relev process oper investig effect process hydrolysi investig properti activ substanc metabolit toxicolog signific degrad product occur result process studi conduct radio label form activ substanc effect residu level aim test main object studi determin quantit distribut residu intermedi end product estim transfer factor enabl realist estim made dietari intak residu test condit process studi repres household process actual industri process instanc carri core set quot balanc studi quot repres common process relev plant plant product signific residu justif select made repres process es technolog process studi correspond close actual condit practic balanc sheet made mass balanc residu intermedi end product investig draw balanc sheet concentr reduct residu individu product recogn transfer factor determin process plant product plai import part diet quot balanc studi quot signific transfer residu process product occur quot follow studi quot determin residu concentr dilut factor carri residu succeed crop aim test object studi permit evalu residu succeed crop circumst requir data gener accord annex ii section point annex iii section point show signific residu gt appli activ substanc total unchang activ substanc relev metabolit degrad product remain soil plant materi straw organ materi sow plant time succeed crop lead residu limit determin succeed crop harvest consider residu situat includ consider natur residu succeed crop involv theoret estim level residu likelihood residu succeed crop exclud metabol distribut studi carri field trial test condit theoret estim residu succeed crop full detail justif metabol distribut studi field trial carri repres crop chosen repres normal agricultur practic propos maximum residu level mrl residu definitiona full justif propos mrl provid includ relev full detail statist analysi judg compound includ residu definit account toxicolog signific compound amount present practic analyt method propos post registr control monitor purpos propos pre harvest interv envisag withhold period storag period case post harvest full justif propos provid estim potenti actual exposur diet mean consider calcul realist predict dietari intak step wise fashion lead increasingli realist predict intak relev sourc exposur residu aris medicin veterinari drug account summari evalu residu behaviour summari evalu data present section carri guidanc compet author member state format summari evalu includ detail critic assess data context relev evalu decis make criteria guidelin refer risk man anim aris extent qualiti reliabl data base toxicolog signific mammalian metabolit address schemat diagram prepar metabol pathwai plant anim explan distribut chemic involv annex ii section part annex iii direct eec replac residu treat product food feed introduct provis annex ii section introduct appli metabol distribut express residu plant livestock aim test object studi provid estim total termin residu relev portion crop harvest treatment propos quantifi rate degrad excret total residu anim product milk egg excreta identifi major compon total termin residu crop edibl anim product distribut residu relev crop part relev edibl anim product quantifi major compon residu show effici extract procedur compon gener data decis livestock feed studi provid point made decid definit express residu circumst requir supplementari metabol studi perform extrapol data obtain activ substanc accord requir annex ii section point case crop livestock data submit framework inclus activ substanc annex amend condit inclus annex expect metabol occur test condit provis provid paragraph annex ii section point appli residu trial aim test object studi quantifi highest residu level treat crop harvest outload store propos good agricultur practic gap determin rate declin pesticid deposit circumst requir supplementari residu trial perform extrapol data obtain activ substanc accord requir annex ii section point case special formul special applic method crop data submit framework inclus activ substanc annex amend condit inclus annex test condit provis provid paragraph annex ii section point appli livestock feed studi aim test object studi determin residu product anim origin result residu feedingstuff fodder crop circumst requir supplementari feed studi purpos assess maximum residu level product anim origin requir extrapol data obtain activ substanc accord requir annex ii section point case addit fodder crop author lead increas intak residu livestock data submit framework inclus activ substanc annex amend condit inclus annex test condit provis provid paragraph annex ii section point appli effect industri process household prepar aim test main object studi establish breakdown reaction product aris residu raw product process requir separ risk assess determin quantit distribut residu intermedi end product estim transfer factor enabl realist estim made dietari intak residu circumst requir supplementari studi perform extrapol data obtain activ substanc accord requir annex ii section point case crop data submit framework inclus activ substanc annex amend condit inclus annex test condit provis provid paragraph annex ii section point appli residu succeed crop aim test object studi permit evalu residu succeed crop circumst requir supplementari studi requir extrapol data obtain activ substanc accord requir annex ii section point case special formul special applic method crop data submit framework inclus activ substanc annex amend condit inclus annex test condit provis provid paragraph annex ii section point appli propos maximum residu level mrl residu definit full justif propos mrl provid includ relev full detail statist analysi metabol studi submit accord provis point residu definit chang take account actual residu definit judgement outlin paragraph annex ii section point evalu activ substanc propos pre harvest interv envisag withhold period storag period case post harvest usesa full justif propos provid estim potenti actual exposur diet mean consider calcul realist predict dietari intak step wise fashion lead increasingli realist predict intak relev sourc exposur residu aris medicin veterinari drug account summari evalu residu behaviour summari evalu data present section carri guidanc compet author member state format summari evalu includ detail critic assess data context relev evalu decis make criteria guidelin refer risk man anim aris extent qualiti reliabl data base metabol data submit toxicolog signific mammalian metabolit address schemat diagram prepar metabol pathwai plant anim explan distribut chemic involv metabol data submit