commiss regul ec decemb lai detail rule implement fourth stage programm work refer articl council direct eec text eea relev commiss european commun regard treati establish european commun regard council direct eec juli place plant protect product market subparagraph articl thereof direct eec commiss undertak programm work period year programm work notif direct gradual examin activ substanc market year date notif direct commiss regul eec decemb lai detail rule implement stage programm work refer articl council direct eec place plant protect product market stage programm work ongo commiss regul ec februari lai detail rule implement stage work programm refer articl council direct eec stage programm work ongo regul ec stage programm work addit number activ substanc cover stage programm commiss regul ec august lai detail rule implement stage programm work refer articl council direct eec amend regul ec stage programm work stage ongo commiss regul ec june lai detail rule implement fourth stage programm work refer articl council direct eec fourth stage work ongo produc wish support inclus activ substanc cover stage annex direct eec undertaken provid inform reason access czech republ estonia cypru latvia lithuania hungari malta poland slovenia slovakia provid opportun produc member state notifi interest particip stage programm work substanc cover stage organis review substanc market member state includ stage programm work procedur establish regul prejudic procedur action undertaken framework commun legisl council direct eec decemb prohibit place market plant protect product activ substanc inform commiss show requir satisfi regul ec european parliament council januari lai gener principl requir food law establish european food safeti author lai procedur matter food safeti 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 relationship produc member state commiss efsa oblig implement programm work laid take account experi gain stage programm work object separ risk assess risk manag organis work effici close cooper produc member state commiss efsa scrupul respect time limit laid ensur effici programm work strict time limit element fourth stage programm set order ensur finalis accept time period activ substanc dossier requir limit short deadlin submiss dossier order opportun inform provid time frame complet review programm order avoid duplic work experi involv vertebr anim produc encourag submit collect dossier defin oblig produc regard format time period nation author efsa inform submit activ substanc cover stage programm work produc small volum specialist purpos import organ low input farm system expect constitut low risk term human environment protect commiss identifi progress report european parliament council evalu activ substanc plant protect product submit accord articl council direct eec place plant protect product market special measur adopt relat low risk compound modifi approach requir stage programm work reduc risk larg number activ substanc withdrawn econom reason group activ substanc format requir inform submit develop activ substanc previou stage programm work interest consist commun legisl ensur measur provid regul coher measur direct ec european parliament council februari place biocid product market notif submiss dossier prerequisit possibl inclus activ substanc annex direct eec place plant protect product market subject provis articl direct person submit notif inform stage evalu process requir continu market plant protect product activ substanc evalu order ensur relev inform potenti danger effect activ substanc residu consid technic scientif inform submit relev time limit person consider evalu cooper notifi ceas imposs continu evalu effici evalu activ substanc termin member state take task evalu distribut compet author member state activ substanc rapporteur member state design rapporteur member state assess complet checklist provid notifi examin evalu inform submit present efsa result evalu make recommend commiss decis regard activ substanc concern group activ substanc rapporteur member state close cooper rapporteur member state group group identifi lead rapporteur coordin cooper rapporteur member state send draft assess report evalu activ substanc efsa draft assess report peer review efsa submit commiss case appar imbal respons born member state rapporteur evalu assess replac member state origin design rapporteur activ substanc member state ensur proper resourc stage programm work fee paid member state handl evalu dossier draft assess report efsa consult propos measur measur provid regul accord opinion stand committe food chain anim health adopt regul chapter subject matter scope definit design member state author articl subject matter scope regul lai detail rule implement fourth stage programm work refer subparagraph articl direct eec programm work respect continu evalu activ substanc notifi regul ec rule cover activ substanc market czech republ estonia cypru latvia lithuania hungari malta poland slovenia slovakia includ stage programm work cover regul ec articl paragraph articl direct eec appli activ substanc list annex regul long procedur provid regul regard substanc finalis regul appli prejudic review member state activ substanc list annex regul pursuant renew authoris accord articl direct eec review commiss accord articl direct eec assess carri direct eec articl definit purpos regul definit set articl direct eec articl regul ec appli definit appli quot notifi quot mean natur legal person submit notif accord regul ec list annex ii regul ii articl regul quot rapporteur member state quot mean rapporteur member state activ substanc set annex quot summari dossier quot mean dossier inform requir articl summari result test studi refer paragraph quot complet dossier quot mean dossier inform requir articl result test studi report refer summari dossier full articl design member state author member state design author author carri oblig member state defin regul nation author list annex iii coordin ensur contact notifi member state commiss european food safeti author efsa accord regul member state give detail design coordin nation author commiss efsa design coordin nation author member state inform modif thereof chapter ii notif produc member state activ substanc articl notif produc member state produc member state refer articl regul wish secur inclus annex direct eec activ substanc list annex regul notifi detail set annex regul commiss notifi substanc rapporteur member state latest month date entri forc regul produc make notif paragraph fulfil oblig produc notifi set regul activ substanc notifi produc member state submit notif activ substanc list annex regul accord paragraph permit particip programm work collect notifi activ substanc includ member state notifi accord paragraph articl notif receiv activ substanc list annex regul member state declar interest support inclus activ substanc annex direct eec notifi commiss rapporteur member state notif submit month date commiss inform member state notif submit activ substanc member state submit notif treat produc purpos evalu activ substanc concern commiss decid provid fourth subparagraph articl direct eec includ annex direct activ substanc refer annex regul notif submit accord paragraph articl decis state reason inclus member state withdraw authoris plant protect product activ substanc period prescrib decis chapter iii condit submiss dossier activ substanc submiss inform parti articl submiss dossier notifi activ substanc list annex notifi notifi concern reason step submit dossier substanc collect dossier submit notifi detail effort made reason notifi particip submiss dossier activ substanc notifi notifi notifi studi involv vertebr anim give detail attempt made avoid duplic test give applic reason conduct duplic studi articl submiss dossier rapporteur member state notifi submit dossier activ substanc dossier rapporteur member state dossier includ copi notif case collect notif made produc refer articl includ copi notif made accord articl regul ec articl regul ii person design produc concern respons collect notif act contact point procedur limit rang repres activ substanc respect data submit notifi dossier demonstr prepar requir set articl direct eec inclus activ substanc annex direct met request rapporteur member state provid articl circul updat summari dossier relev updat complet dossier part thereof notifi latest month date receipt request articl dossier activ substanc submit direct ec derog articl activ substanc notifi direct ec notifi submit copi dossier submit direct ec addit inform refer annex ii iii direct eec justifi inclus activ substanc annex direct refer fall scope direct articl dossier activ substanc submit regul ec dossier submit regul ec person submit dossier submit dossier submit regul refer dossier submit regul ec addit inform refer annex ii iii direct eec justifi inclus activ substanc annex direct refer fall scope regul articl specif condit submiss dossier activ substanc list part annex dossier concern activ substanc list part annex addit inform requir articl articl notifi submit inform activ substanc plant protect product applic inform risk human anim health environ includ search literatur identifi data base search search term assess report oecd countri ongo test studi fulli complet inform test studi project date complet dossier physic individu test studi report inform refer paragraph member state number copi dossier submit notifi act rapporteur receiv copi articl format dossier account recommend made accord procedur refer articl direct eec articl specif condit submiss dossier activ substanc list part annex dossier concern activ substanc list part annex notifi submit dossier summari dossier notifi includ summarydossi inform requir articl articl regul point annex ii part part direct eec point annex iii part part direct summari result test studi person institut carri test studi checklist fill notifi demonstr dossier complet accord articl regul test studi refer paragraph articl relev assess criteria refer articl direct eec prepar take account fact data gap dossier inform requir annex ii direct eec result propos limit rang repres activ substanc lead restrict inclus annex direct eec complet dossier physic individu test studi report inform refer point subparagraph paragraph member state number copi format summari complet dossier submit notifi defin format complet summari dossier member state account recommend made accord procedur refer articl direct eec articl submiss inform parti natur legal person wish submit relev inform contribut evalu activ substanc list annex regard potenti danger effect substanc residu human anim health environ relev time limit set articl inform submit rapporteur member state efsa request rapporteur member state person submit inform member state latest month date receipt request articl time limit submiss dossier notifi submit dossier relev rapporteur member state june latest activ substanc list part annex novemb latest activ substanc list part annex articl submiss dossier notifi submit dossier part thereof relev time limit set articl rapporteur member state inform commiss efsa month date expiri time limit give justif delai provid notifi basi inform submit rapporteur member state accord paragraph commiss determin notifi demonstr delai submiss dossier caus forc majeur case establish time limit submiss dossier fulfil relev requir articl regul accord procedur refer articl direct eec commiss decid provid fourth subparagraph articl direct eec includ annex direct activ substanc dossier submit time limit provid articl regul subparagraph paragraph articl decis state reason inclus member state withdraw authoris plant protect product activ substanc period prescrib decis articl replac withdraw notifi notifi decid end particip programm work activ substanc immedi inform rapporteur member state commiss efsa notifi activ 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 relev provis 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 notifi activ substanc end particip programm work member state choos act notifi purpos particip programm work member state wish act notifi inform rapporteur member state commiss efsa latest month date inform notifi decid end particip replac origin notifi carri notifi duti pursuant relev provis articl inform submit remain rapporteur member state commiss efsa chapter iv evalu dossier articl gener condit evalu dossier prejudic articl rapporteur member state evalu dossier submit prejudic articl direct eec rapporteur member state accept submiss studi evalu provid articl regul rapporteur member state request notifi submit data clarifi dossier rapporteur member state set time limit inform provid time limit affect time limit submiss draft assess report rapporteur member state efsa provid articl articl rapporteur member state start evalu dossier consult expert efsa request addit technic scientif inform member state assist evalu notifi seek specif advic rapporteur member state articl cooper member state rapporteur member state cooper evalu group set annex organis cooper effect effici rapporteur member state identifi group annex quot lead rapporteur quot lead organis cooper organis provis advic notifi concern matter gener interest member state concern articl specif condit evalu activ substanc list part annex affect time limit submiss draft assess report provid articl rapporteur member state evalu inform identifi articl subsequ provid notifi articl complet check dossier substanc list part annex rapporteur member state assess checklist provid notifi accord articl rapporteur member state latest month date receipt dossier activ substanc report commiss complet dossier activ substanc dossier consid complet rapporteur member state perform evalu refer articl commiss inform rapporteur member state month date receipt report rapporteur member state complet dossier complet activ substanc rapporteur member state commiss dossier complet mean articl commiss month date receipt report rapporteur member state complet refer report stand committe food chain anim health accord procedur refer 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 time limit provid articl regul paragraph articl articl specif condit evalu dossier substanc list part annex activ substanc list part annex regul evalu direct ec evalu account relev purpos regul activ substanc evalu stage programm work refer articl direct eec evalu account relev purpos regul rapporteur member state evalu report activ substanc dossier determin complet accord articl dossier activ substanc determin complet check ident impur activ substanc dossier compar ident impur activ substanc dossier consid complet record view point draft assess report rapporteur member state consider inform potenti danger effect dossier submit notifi parti accord articl articl gener condit draft assess report draft assess report submit format recommend accord procedur refer articl direct eec 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 notifi provid updat dossier date request articl specif condit draft assess report recommend commiss activ substanc list part annex rapporteur member state send draft assess report efsa quickli month date expiri time limit provid articl latest rapporteur member state includ draft assess report refer test studi point annex ii part part direct eec point annex iii part part 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 time rapporteur member state send assess report efsa provid paragraph make recommend commiss includ activ substanc annex direct eec state propos condit inclus condit includ time limit inclus ii state inform requir addit inform includ test studi refer articl regul probabl timet provis inform includ activ substanc annex direct eec state propos reason inclus addit condit inclus propos paragraph articl rapporteur member state identifi propos limit rang repres mention dossier inform miss dossier requir member state confirmatori inform grant authoris articl direct eec plant protect product activ substanc articl specif condit draft assess report recommend commiss activ substanc list part annex rapporteur member state send draft assess report efsa quickli latest month date dossier determin complet accord articl rapporteur member state includ draft assess report refer test studi point annex ii part part direct eec point annex iii part part 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 time rapporteur member state send assess report efsa provid paragraph make recommend commiss includ activ substanc annex direct eec state reason inclus includ activ substanc annex direct eec state reason inclus articl replac rapporteur member state rapporteur member state inform commiss efsa clear unabl compli time limit set articl submiss draft assess report efsa give reason delai decid replac rapporteur member state activ substanc member state assess evalu provid articl appar imbal respons born work member state rapporteur clear member state unabl fulfil oblig regul replac decid accord procedur refer articl direct eec decid replac rapporteur member state origin rapporteur member state immedi decis inform notifi concern transfer newli design rapporteur member state correspond inform receiv rapporteur member state activ substanc concern origin member state return notifi part fee refer articl newli design rapporteur member state requir payment fee accord articl articl evalu efsa efsa dai date receipt draft assess report provid articl articl regul check compli format recommend accord procedur refer articl direct eec except case draft assess report fulfil requir commiss agre efsa rapporteur member state period resubmiss amend report exce month efsa circul draft assess report member state commiss organis consult expert includ rapporteur member state efsa consult notifi activ substanc refer annex draft assess report part thereof relev activ substanc prejudic articl direct eec submiss studi accept efsa receipt draft assess report refer paragraph articl rapporteur member state agreement efsa request notifi submit time limit data consid rapporteur member state efsa clarifi dossier efsa make specif request consult person draft assess report element thereof accept confidenti accord articl direct eec list data requir evalu inclus activ substanc annex direct eec finalis efsa efsa evalu draft assess report submit evalu commiss activ substanc expect meet requir articl direct eec latest year date receiv dossier notifi articl regul draft assess report check complianc accord paragraph articl efsa give evalu option claim meet requir articl direct eec data requir identifi commiss efsa agre schedul submiss evalu order facilit plan work commiss efsa agre format evalu chapter present draft direct draft decis activ substanc finalis review report articl present draft direct draft decis commiss present draft review report latest month date receipt efsa evalu provid articl prejudic propos submit view amend annex direct eec basi finalis review report provid articl regul commiss present stand committe food chain anim health draft direct includ activ substanc annex direct eec state condit inclus condit includ time limit inclus draft decis address member state pursuant fourth subparagraph articl direct eec includ activ substanc annex direct eec state reason inclus requir member state withdraw authoris plant protect product activ substanc direct decis adopt accord procedur refer articl direct eec addit condit inclus propos paragraph commiss identifi inform miss dossier requir member state grant authoris articl direct eec articl finalis review report conclus stand committe food chain anim health exclud part refer confidenti inform contain dossier determin accord articl direct eec made publicli chapter vi suspens time limit measur member state interim progress report articl suspens time limit respect activ substanc list annex regul commiss present propos total prohibit draft council act base articl direct eec time limit provid regul suspend council consid propos council adopt amend annex direct eec requir total prohibit activ substanc procedur regul termin activ substanc articl measur member state member state basi inform contain dossier refer articl draft assess report activ substanc refer articl intend take action withdraw activ substanc market restrict sever plant protect product activ substanc inform commiss efsa member state notifi give reason intend action articl interim progress report member state submit commiss efsa report progress evalu activ substanc rapporteur report submit novemb activ substanc list part annex novemb activ substanc list part annex chapter vii fee charg articl fee activ substanc list annex member state establish regim oblig notifi pai fee charg administr treatment evalu dossier incom fee charg financ exclus cost incur rapporteur member state financ gener activ member state result oblig articl member state establish amount fee charg refer paragraph transpar manner exce real cost examin administr treatment dossier gener activ member state result oblig articl member state provid scale fix charg base averag cost calcul total fee fee charg paid accord procedur establish author member state list annex iv articl charg tax levi fee articl prejudic member state right maintain introduc extent permit commun law charg tax levi fee regard authoris place market control activ substanc plant protect product fee charg provid articl chapter viii temporari final provis 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 entri forc regul enter forc seventh dai public offici journal european union regul bind entireti directli applic member state brussel decemb commiss marko kyprian member commiss oj direct amend commiss direct ec oj oj regul amend regul ec oj oj regul amend regul ec oj oj regul amend regul ec oj oj oj direct amend regul ec oj oj regul amend regul ec final oj direct amend regul ec oj annex annex annex annex annex