commiss direct ec juli 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 annex ii iii applic precis detail requir inform circumst condit technic protocol data gener provis introduc order permit applic prepar file introduc detail regard data requir analyt method activ substanc provid section part annex ii introduc detail regard data requir analyt method 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 analyt method replac annex hereto part annex iii section head analyt method replac annex ii hereto articl member state bring forc law regul administr provis compli direct april immedi inform commiss thereof member state adopt measur refer direct accompani refer time offici public procedur refer adopt member state articl direct enter forc articl direct address member state brussel juli commiss franz fischler member commiss oj oj annex analyt method introduct provis section cover analyt method requir post registr control monitor purpos analyt method gener data requir direct purpos applic provid justif method separ guidanc develop method basi requir defin method post registr control monitor purpos descript method provid includ detail equip materi condit practic method emploi simplest approach involv minimum cost requir commonli equip section appli gt tabl gt request sampl provid analyt standard pure activ substanc ii sampl activ substanc manufactur iii analyt standard relev metabolit compon includ residu definit iv sampl refer substanc relev impur method analysi activ substanc manufactur point definit appli specif specif abil method distinguish analyt measur substanc ii linear linear defin abil method rang obtain accept linear correl result concentr analyt sampl iii accuraci accuraci method defin degre determin analyt sampl correspond accept refer iso iv precis precis defin close agreement independ test result obtain prescrib condit repeat precis repeat condit condit independ test result obtain method ident test materi laboratori oper equip short interv time reproduc requir activ substanc manufactur definit reproduc iso method full provid determin pure activ substanc activ substanc manufactur dossier submit support inclus annex direct eec applic exist cipac method report method provid determin signific relev impur addit stabil activ substanc manufactur specif linear accuraci repeat specif method submit demonstr report addit extent interfer substanc present activ substanc manufactur isom impur addit determin interfer due compon identifi systemat error assess accuraci method propos determin pure activ substanc activ substanc manufactur explan provid interfer occur contribut total quantiti determin degre interfer method determin impur demonstr linear propos method rang determin report determin pure activ substanc calibr rang extend highest lowest nomin content analyt relev analyt solut duplic calibr determin made concentr altern concentr singl measur accept report submit includ equat calibr line correl coeffici repres properli label document analysi chromatogram accuraci requir method determin pure activ substanc signific relev impur activ substanc manufactur repeat determin pure activ substanc principl minimum determin made rel standard deviat rsd report outlier identifi method dixon grubb test discard outlier discard fact explan reason occurr individu outlier attempt method determin residu method capabl determin activ substanc relev metabolit method relev repres matrix specif precis recoveri limit determin experiment determin report principl residu method propos multi residu method standard multi residu method assess report suitabl residu determin residu method propos multi residu method compat method altern method propos requir result excess number method individu compound quot common moieti method quot accept section definit appli specif specif abil method distinguish analyt measur substanc ii precis precis defin close agreement independ test result obtain prescrib condit repeat precis repeat condit condit independ test result obtain method ident test materi laboratori oper equip short interv time reproduc definit reproduc relev public iso gener practic residu analyt method reproduc context direct defin valid repeat recoveri repres matric repres level laboratori independ initi valid studi independ laboratori compani independ laboratori valid iii recoveri percentag amount activ substanc relev metabolit origin ad sampl matrix detect level analyt iv limit determin limit determin refer limit quantif defin lowest concentr test accept recoveri obtain rel standard deviat prefer amp le justifi case lower higher recoveri rate higher rel standard deviat accept residu plant plant product foodstuff plant anim origin feedingstuff method submit suitabl determin compon includ residu definit submit provis section point order enabl member state determin complianc establish mrl determin dislodg residu specif method enabl compon includ residu definit determin addit confirmatori method repeat determin report replic analyt portion test prepar common field treat sampl incur residu altern replic analyt portion test prepar common untreat sampl aliquot fortifi requir level result independ laboratori valid report limit determin includ individu recoveri determin report rel standard deviat rel standard deviat fortif level experiment determin report residu soil method analysi soil parent compound relev metabolit submit specif method enabl parent compound relev metabolit determin addit confirmatori method repeat recoveri limit determin includ individu recoveri determin report rel standard deviat rel standard deviat fortif level experiment determin report propos limit determin exce concentr concern regard exposur target organ phytotox effect propos limit determin exce mg kg residu water includ drink water ground water surfac water method analysi water parent compound relev metabolit submit specif method enabl parent compound relev metabolit determin addit confirmatori method repeat recoveri limit determin includ individu recoveri determin report rel standard deviat rel standard deviat fortif level experiment determin report drink water propos limit determin exce ìg surfac water propos limit determin exce concentr impact target organ deem unaccept requir annex vi residu air method analysi air activ substanc relev metabolit form shortli applic submit justifi exposur oper worker bystand occur specif method enabl parent compound relev metabolit determin addit confirmatori method repeat recoveri limit determin includ individu recoveri determin report rel standard deviat rel standard deviat fortif level experiment determin report propos limit determin account relev health base limit valu relev exposur level residu bodi fluid tissu activ substanc classifi toxic highli toxic analyt method submit specif method enabl parent compound relev metabolit determin addit confirmatori method repeat recoveri limit determin includ individu recoveri determin report rel standard deviat rel standard deviat fortif level experiment determin report annex ii analyt method introduct provis section cover analyt method requir post registr control monitor purpos analyt method gener data requir direct purpos applic provid justif method separ guidanc develop method basi requir defin method post registr control monitor purpos descript method provid includ detail equip materi condit practic method emploi simplest approach involv minimum cost requir commonli equip section appli gt tabl gt request sampl provid sampl prepar ii analyt standard pure activ substanc iii sampl activ substanc manufactur iv analyt standard relev metabolit compon includ residu definit sampl refer substanc relev impur definit annex ii section point method analysi prepar method full provid determin activ substanc prepar case prepar activ substanc method capabl determin presenc provid combin method submit technic reason state applic exist cipac method report method provid determin prepar relev impur composit prepar basi theoret consider impur form manufactur process degrad storag requir method determin formul constitu formul prepar submit specif linear accuraci repeat specif method submit demonstr report addit extent interfer substanc present prepar determin interfer due compon identifi systemat error assess accuraci method propos explan provid interfer occur contribut total quantiti determin linear propos method rang determin report calibr rang extend highest lowest nomin content analyt relev analyt solut prepar duplic calibr determin made concentr altern concentr singl measur accept report submit includ equat calibr line correl coeffici repres properli label document analysi chromatogram accuraci requir method determin pure activ substanc relev impur prepar repeat principl minimum determin made rel standard deviat rsd report outlier identifi method dixon grubb test discard outlier discard fact explan reason occurr individu outlier attempt analyt method determin residu analyt method determin residu submit justifi method submit requir annex ii section point appli provis provid annex ii section point appli