commiss regul ec august lai detail rule implement stage programm work refer articl council direct eec amend regul ec 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 subparagraph articl thereof commiss undertak programm work gradual examin activ substanc market year date notif direct eec period year stage programm laid commiss regul eec decemb lai detail rule implement stage programm work refer articl council direct eec place plant protect product market amend regul ec stage ongo stage work laid commiss regul ec februari lai detail rule implement stage work programm refer articl council direct eec ongo stage work provid regul ec addit number activ substanc cover stage programm produc wish secur inclus activ substanc annex direct eec provid detail inform relat current stage complet dossier endpoint undertaken provid full data packag stage work programm articl regul ec specifi detail provis submiss complet dossier time limit submiss fee regim activ substanc concern establish commiss regul adopt accord subparagraph articl direct eec regul ec european parliament council januari creat european food safeti author efsa ensur commun access high qualiti independ effici scientif technic support order achiev high level health protect relat legisl safeti food feed provid efsa role programm work activ substanc scope involv defin order ensur dossier receiv member state manag activ substanc evalu divid group separ time limit submiss dossier initi stage suffici notifi provid list test studi rapporteur member state order permit member state establish full data packag submit time limit data time limit complet evalu activ substanc timet provid direct eec decis immedi includ substanc concern annex direct authoris product activ substanc withdrawn member state relationship produc member state commiss efsa oblig implement programm laid take account experi gain stage programm close cooper parti involv scrupul respect time limit laid ensur effici programm strict time limit element stage work programm set order ensur finalis accept time period cooper notifi ceas imposs continu evalu effici evalu termin order ensur relev inform potenti danger effect activ substanc residu consid technic scientif inform submit relev time limit person consider evalu defin oblig notifi regard format time period recipi author inform submit task evalu distribut compet author member state activ substanc rapporteur member state design rapporteur member state assess complet check provid notifi examin evalu inform submit present efsa result evalu make recommend commiss decis regard activ substanc concern member state send draft report evalu efsa draft report prepar rapporteur member state peer review efsa submit stand committe food chain anim health order avoid duplic work experi involv vertebr anim produc encourag submit collect dossier notif submiss dossier prerequisit possibl inclus activ substanc annex direct eec place plant protect product market subject provis articl direct oper submit notif inform stage evalu process requir continu market plant protect product activ substanc evalu procedur establish regul prejudic procedur action undertaken framework commun legisl council direct eec prohibit place market plant protect product activ substanc amend act access austria finland sweden inform commiss show requir satisfi anti microbi class human veterinari medicin purpos plant protect discourag substanc concern regul kasugamycin streptomycin fall categori pend eventu decis inclus annex continu restrict permit essenti purpos evalu inform anti microbi resist requir regul prejudic commun oblig methyl bromid montreal protocol case appar imbal respons born member state rapporteur assess evalu replac member state origin design rapporteur activ substanc member state ensur proper resourc stage programm work fee paid member state handl evalu dossier addit fee paid evalu notif pursuant articl regul ec regul ec provid activ substanc cover stage work programm time limit submiss full data packag latest regul provid detail provis submiss complet dossier establish stage order organis work programm effici submit full data packag shortli full dossier submit ensur activ substanc full data packag remain market list data submit full data packag submit except case request regul ec amend measur provid regul accord opinion stand committe food chain anim health adopt regul articl subject matter scope regul lai detail rule implement stage programm work refer articl direct eec respect continu evalu activ substanc notifi regul ec articl subparagraph direct eec appli substanc list annex regul long procedur provid regul regard substanc finalis regul appli prejudic review member state activ substanc annex pursuant renew authoris accord articl direct eec review commiss pursuant articl direct eec assess carri direct eec articl definit purpos regul definit direct eec appli definit appli quot notifi quot mean natur legal person submit notif accord term regul ec list annex ii quot committe quot mean stand committe food chain anim health refer articl direct eec quot data list quot mean list data submit full data packag quot full data packag quot mean inform result studi suffici satisfi requir annex ii iii direct eec relat limit rang repres activ substanc concern articl member state author member state alloc respons implement oblig programm work refer articl direct eec author author member state design nation author refer annex iii coordin ensur contact notifi member state commiss european food safeti author efsa pursuant regul member state inform detail design coordin nation author commiss efsa design coordin nation author member state modif thereof articl measur case imbal assess evalu refer articl appar imbal respons born work member state rapporteur decid accord procedur provid articl direct eec replac member state origin design rapporteur activ substanc member state case origin rapporteur member state inform notifi concern transfer newli design rapporteur member state correspond inform receiv rapporteur member state activ substanc concern origin member state return notifi fee refer articl part refer paragraph thereof newli design rapporteur member state requir notifi pai fee refer articl part refer paragraph thereof articl withdraw replac notifi notifi decid end particip programm work activ substanc immedi inform rapporteur member state commiss efsa notifi substanc concern decis give reason notifi end particip fail fulfil oblig regul procedur provid articl termin dossier notifi agre produc notifi replac purpos particip programm work regul notifi produc inform rapporteur member state commiss efsa common declar agre produc replac origin notifi carri notifi duti pursuant articl ensur notifi substanc concern inform time produc case jointli liabl origin notifi fee remain payabl relat notifi applic regim establish member state pursuant articl inform submit remain rapporteur member state commiss efsa articl submiss check data list latest notifi submit relev rapporteur member state data list activ substanc list annex submit copi efsa activ substanc list annex notif notifi concern reason step submit data list collect data list submit notifi concern mention effort made reason notifi particip activ substanc notifi notifi notifi studi involv vertebr anim detail attempt made avoid duplic test give applic reason conduct duplic studi data list prepar format accord procedur provid articl direct eec full data packag defin articl regul ec notifi written request rapporteur member state commiss notifi provid delai part data packag full data packag request rapporteur member state examin data list submit establish full data packag submit activ substanc rapporteur member state consid full data packag submit rapporteur member state request notifi submit delai full data packag check complet rapporteur member state report result check commiss latest month receipt data list activ substanc rapporteur member state consid full data packag inform commiss delai accord procedur provid articl direct eec decid full data packag consid full data packag activ substanc commiss decid provid fourth subparagraph articl direct eec includ activ substanc concern annex direct eec commiss inform notifi full data packag activ substanc notifi submit dossier refer articl time limit articl articl submiss dossier notifi submit relev rapporteur member state summari dossier refer paragraph complet dossier refer paragraph novemb latest activ substanc list annex part novemb latest activ substanc list annex part activ substanc list annex notif notifi concern reason step submit dossier collect dossier submit notifi concern mention effort made reason notifi particip activ substanc notifi notifi notifi studi involv vertebr anim detail attempt made avoid duplic test give applic reason conduct duplic studi summari dossier includ copi notif case joint applic made produc copi notif made accord articl regul ec person design produc concern respons joint dossier process dossier accord regul limit rang repres activ substanc respect data submit notifi dossier demonstr prepar requir set articl direct eec inclus activ substanc annex direct eec met point annex ii direct eec summari result studi trial person institut carri trial ii point annex iii direct eec summari result studi trial person institut carri trial relev assess criteria refer articl direct eec prepar repres refer subparagraph take account data gap inform annex ii dossier result propos limit rang repres activ substanc lead restrict inclus annex direct eec iii activ substanc list annex part studi fulli complet evid studi commiss requir articl regul ec undertak submit latest checklist fill notifi demonstr dossier complet complet dossier physic individu test studi report inform refer paragraph evid refer paragraph iii work progress member state defin number copi format summari complet dossier submit notifi defin format dossier member state account recommend made accord procedur provid articl direct eec dossier part relev time limit rapporteur member state inform commiss efsa month give justif delai provid notifi basi inform transmit rapporteur member state accord paragraph commiss determin notifi demonstr delai submiss dossier caus forc majeur case establish time limit submiss dossier fulfil requir paragraph accord procedur provid articl direct eec commiss decid provid fourth subparagraph articl direct eec includ annex direct eec activ substanc dossier submit establish time limit articl submiss inform parti person wish submit inform contribut evalu regard potenti danger effect activ substanc residu human anim health environ rapporteur member state novemb latest substanc list annex part novemb latest substanc list annex part rapporteur member state submit inform receiv efsa articl complet check dossier activ substanc design rapporteur member state examin dossier refer articl assess checklist provid notifi rapporteur member state latest month receipt dossier activ substanc report efsa commiss complet dossier efsa assess report submit rapporteur member state report commiss complet dossier activ substanc dossier consid complet rapporteur member state perform evalu refer articl efsa inform rapporteur member state commiss month receipt member state report complet dossier complet activ substanc dossier complet provid articl iii report confirm date dossier complet date evalu refer articl begin activ substanc rapporteur member state efsa dossier complet mean articl commiss month receipt report rapporteur member state efsa refer report committe accord procedur provid articl direct eec decid dossier consid complet mean articl commiss decid provid fourth subparagraph articl direct eec includ annex direct eec activ substanc complet dossier submit prescrib time limit articl evalu rapporteur member state rapporteur member state evalu report activ substanc dossier determin complet accord articl activ substanc evalu report complet dossier dossier check ident impur activ substanc rapporteur member state consider inform potenti danger effect dossier submit notifi parti accord provis articl send draft report assess dossier efsa quickli latest month dossier determin complet draft assess report submit format recommend accord procedur provid articl direct eec time rapporteur member state make recommend commiss includ activ substanc annex direct eec state condit inclus includ activ substanc annex direct eec state reason inclus rapporteur member state includ draft assess report refer test studi report point annex ii annex iii direct eec reli assess refer made form list test studi report includ titl author date studi test report date public standard test studi conduct holder claim made holder notifi data protect mention notifi sourc activ substanc dossier consid complet conclud activ substanc compar mean articl direct eec prejudic articl direct eec submiss studi accept studi articl regul ec rapporteur member state request notifi submit data clarifi dossier rapporteur member state set time limit inform provid time limit affect time limit submiss report refer paragraph rapporteur member state start examin dossier consult expert efsa request addit technic scientif inform member state assist evalu rapporteur member state perform evalu rapporteur member state rapporteur member state request notifi submit updat summari dossier efsa member state request commiss time rapporteur draft assess report efsa member state commiss efsa request rapporteur member state notifi send updat complet dossier part thereof evid rapporteur member state unabl compli time limit paragraph submiss draft assess report efsa inform commiss efsa give reason delai activ substanc reassign member state accord procedur provid articl direct eec articl evalu efsa receiv updat summari dossier draft assess report refer articl efsa dai acknowledg receipt report rapporteur member state except case draft assess report fulfil requir format recommend commiss commiss agre efsa rapporteur member state period resubmiss amend report period exce month efsa circul rapporteur draft assess report member state organis consult expert includ rapporteur member state efsa consult notifi activ substanc annex report part report relev activ substanc prejudic articl direct eec submiss studi accept studi refer articl regul ec rapporteur member state agreement efsa request notifi submit period data consid rapporteur member state efsa clarifi dossier efsa make specif request consult person inform refer subparagraph articl element thereof accept confidenti accord articl direct eec activ substanc content pure activ substanc manufactur materi list data requir consider inclus activ substanc annex direct eec contain rapporteur report finalis efsa draft assess report element thereof accept confidenti accord articl direct eec efsa evalu rapporteur draft assess report deliv opinion activ substanc expect meet safeti requir direct eec commiss latest year receipt rapporteur member state draft assess report efsa give opinion option claim meet safeti requir commiss efsa agre schedul deliveri opinion order facilit plan work commiss efsa agre format opinion efsa submit articl present draft direct draft decis latest month receipt efsa opinion refer articl commiss submit draft review report prejudic propos submit view amend annex direct eec basi finalis review report submit committe draft direct includ activ substanc annex direct eec set condit includ time limit inclus draft decis address member state withdraw authoris plant protect product activ substanc pursuant fourth subparagraph articl direct eec activ substanc includ annex direct eec mention reason inclus direct decis adopt accord procedur provid articl direct eec articl finalis review report commiss submit draft direct draft decis accord articl time submit conclus committe examin format finalis review report note summari record meet finalis review report exclud part refer confidenti inform contain dossier determin accord articl direct eec made public consult articl suspens time limit respect substanc list annex commiss submit propos total prohibit direct eec time limit provid regul suspend decis propos council decid total prohibit substanc annex direct eec procedur regul termin articl measur member state member state basi inform contain dossier refer articl report activ substanc refer articl envisag take action withdraw market restrict sever plant protect product substanc inform commiss efsa member state notifi give reason intend action articl interim progress report member state provid commiss efsa report progress evalu activ substanc rapporteur report made novemb activ substanc mention annex part novemb annex part articl fee member state establish regim oblig notifi pai fee charg administr treatment evalu dossier purpos member state requir payment fee charg submiss dossier ensur amount fee charg establish transpar manner view correspond real cost examin administr treatment dossier exclud member state provid scale fix charg base averag cost calcul total fee ensur fee charg receiv accord instruct organis member state list annex iv incom fee charg financ exclus cost incur member state evalu administr treatment dossier member state rapporteur financ gener action implement oblig member state result articl requir part fee charg cover cost rapporteur member state oblig result articl articl paid time submiss data list refer articl part refund circumst articl charg tax levi fee articl prejudic member state right maintain introduc extent permit treati charg tax levi fee regard authoris place market control activ substanc plant protect product fee provid articl articl temporari measur case case basi commiss temporari measur provid subparagraph articl direct eec addit technic evid provid demonstr essenti activ substanc effici altern articl amend regul ec regul ec amend articl replac quot articl evalu dossier rapporteur member state efsa rapporteur member state evalu report activ substanc dossier determin complet accord articl activ substanc evalu report complet dossier dossier check ident impur activ substanc rapporteur member state consider inform potenti danger effect dossier submit notifi parti accord provis articl send draft report assess dossier european food safeti author efsa quickli latest month dossier determin complet draft assess report submit format recommend accord procedur provid articl direct time rapporteur member state make recommend commiss includ activ substanc annex direct state condit inclus includ activ substanc annex direct state reason inclus rapporteur member state includ draft assess report refer test studi report point annex ii annex iii direct reli assess refer made form list test studi report includ titl author date studi test report date public standard test studi conduct holder claim made holder notifi data protect mention notifi sourc activ substanc dossier consid complet conclud activ substanc compar mean articl direct prejudic articl direct submiss studi accept studi refer articl indent rapporteur member state request notifi submit data clarifi dossier rapporteur member state set time limit inform provid time limit affect time limit submiss report refer paragraph rapporteur member state start examin consult expert efsa request addit technic scientif inform member state assist evalu rapporteur member state perform evalu rapporteur member state rapporteur member state request notifi submit updat summari dossier efsa member state request commiss time rapporteur draft assess report efsa member state efsa commiss request rapporteur member state notifi send updat complet dossier part thereof evid rapporteur member state unabl compli time limit paragraph submiss draft assess report efsa inform commiss efsa give reason delai member state provid commiss efsa report progress evalu activ substanc rapporteur report made april receiv updat summari dossier draft assess report refer paragraph efsa dai acknowledg receipt report rapporteur member state except case draft assess report fulfil requir format recommend commiss commiss agre efsa rapporteur member state period resubmiss amend report period exce month efsa circul rapporteur draft assess report member state organis consult expert includ rapporteur member state efsa consult notifi activ substanc annex report part report relev activ substanc prejudic articl direct submiss studi accept rapporteur member state agreement efsa request notifi submit period data consid rapporteur member state efsa clarifi dossier efsa make specif request consult person inform refer subparagraph paragraph element thereof accept confidenti accord articl direct activ substanc content pure activ substanc manufactur materi list data requir consider inclus activ substanc annex direct contain rapporteur report finalis efsa draft assess report element thereof accept confidenti accord articl direct efsa evalu rapporteur draft assess report deliv opinion activ substanc expect meet safeti requir direct commiss latest year receipt rapporteur member state draft assess report efsa give opinion option claim meet safeti requir commiss efsa agre schedul deliveri opinion order facilit plan work commiss efsa agre format opinion efsa submit latest month receipt efsa opinion refer paragraph commiss submit draft review report prejudic propos submit view amend annex direct eec basi finalis review report submit committe draft direct includ activ substanc annex direct set condit includ time limit inclus draft decis address member state withdraw authoris plant protect product activ substanc pursuant fourth subparagraph articl direct activ substanc includ annex direct mention reason inclus direct decis adopt accord procedur provid articl direct commiss submit draft direct draft decis accord paragraph time submit conclus committe examin format finalis review report note summari record meet finalis review report exclud part refer confidenti inform contain dossier determin accord articl direct made public consult quot articl sentenc replac quot time limit submiss list studi full data packag latest quot articl sentenc replac quot member state withdraw juli authoris plant protect product activ substanc admiss notif submit authoris plant protect product activ substanc list studi submit full data packag withdrawn deadlin refer decis inclus activ substanc concern quot annex part relat activ substanc tolclofo methyl quot netherland quot replac quot sweden quot articl entri forc regul enter forc seventh dai public offici journal european commun regul bind entireti directli applic member state brussel august commiss margot wallström member commiss oj oj oj oj oj oj oj opinion scientif steer committe anti microbi resist annex list activ substanc column rapporteur member state column notifi produc code identif column part gt tabl gt part gt tabl gt annex ii list notifi code identif name address gt tabl gt annex iii coordin author member state detail websit http www europa eu int comm food fs ph ps pro index en htm austria bundesamt für ernährungssicherheit landwirtschaftlich untersuchungen und forschung wein spargelfeldstraß wien belgium ministèr de class moyenn de agricultur servic qualité de matièr premièr analys wtc étage boulevard bolivar bruxel denmark ministri environ energi danish environment protect agenc pesticid divis strandgad dk copenhagen germani biologisch bundesanstalt für land und forstwirtschaft bba abteilung für pflanzenschutzmittel und anwendungstechnik ap messeweg braunschweig greec hellen republ ministri agricultur gener director plant produc director plant produc protect depart pesticid hippokrat street gr athen spain ministerio de agricultura pesca alimentación dirección gener de agricultura subdirección gener de medio de producción agrícola ciudad de barcelona madrid finland kasvintuotannon tarkastuskesku torjunta aineet pl fin helsinki franc ministèr de agricultur de aliment de la pêche de affair rural sou direct de la qualité de la protect de végétaux bureau de la réglement de la mise sur le marché de intrant rue de vaugirard pari cedex ireland pesticid control servic depart agricultur food abbotstown laboratori complex abbotstown castleknock dublin ireland itali ministero della salut direzion general della sanità pubblica veterinaria degli alimenti della nutrizion piazza marconi roma luxembourg administr de servic techniqu de agricultur servic de la protect de végétaux boît postal rout esch luxembourg netherland colleg voor de toelat van bestrijdingsmiddelen postbu ae wageningen nederland portug direcção geral de protecção da cultura quinta marquê oeira sweden kemikalieinspektionen box solna unit kingdom pesticid safeti director depart environ food rural affair mallard hous king pool peasholm green york yo px unit kingdom annex iv organis member state contact detail payment fee refer articl fee paid austria bundesamt für ernährungssicherheit landwirtschaftlich untersuchungen und forschung wein spargelfeldstraß wien belgium fond budgétair de matièr premièr ministèr de class moyenn de agricultur inspect générale de matièr premièr produit transformé wtc boulevard bolivar bruxel account number banqu de la post denmark ministri environ energi danish environment protect agenc strandgad dk copenhagen germani biologisch bundesanstalt für land und forstwirtschaft abteilung für pflanzenschutzmittel und anwendungstechnik messeweg braunschweig greec hellen republ ministri agricultur gener director plant produc director plant produc protect depart pesticid hippokrat street gr athen spain ministerio de agricultura pesca alimentación dirección gener de agricultura subdirección gener de medio de producción agrícola ciudad de barcelona madrid finland kasvintuotannon tarkastuskesku torjunta aineet pl fin helsinki bank account leonia bank plc psp bfihh franc ministèr de agricultur de la pêche bureau de la réglement de produit antiparasitair rue de vaugirard pari cedex ireland pesticid control servic depart agricultur food rural develop abbotstown laboratori complex abbotstown castleknock dublin ireland itali tesoreria provincial dello stato di viterbo post current account number luxembourg administr de servic techniqu de agricultur boît postal luxembourg netherland colleg voor de toelat van bestrijdingsmiddelen postbu ae wageningen nederland portug direcção geral de protecção da cultura quinta marquê oeira account number bank caixa geral de depósito sweden kemikalieinspektionen box solna nation giro account unit kingdom pesticid safeti director depart environ food rural affair mallard hous king pool peasholm green york yo px unit kingdom