direct ec european parliament council march deliber releas environ genet modifi organ repeal council direct eec european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur laid articl treati light joint text approv concili committe decemb report commiss review council direct eec april deliber releas environ genet modifi organ adopt decemb identifi number area improv need clarif scope direct eec definit direct eec amend amend made direct desir reason clariti rationalis provis question recast live organ releas environ larg small amount experiment purpos commerci product reproduc environ cross nation frontier affect member state effect releas environ irrevers protect human health environ requir due attent control risk deliber releas environ genet modifi organ gmo treati action commun relat environ base principl prevent action approxim law member state deliber releas environ gmo ensur safe develop industri product utilis gmo precautionari principl account draft direct account implement respect ethic principl recognis member state import member state consider ethic aspect gmo deliber releas market product comprehens transpar legisl framework ensur public consult commiss member state prepar measur inform measur implement direct place market cover import product consist gmo cover direct import commun compli provis make gmo import handl bulk quantiti agricultur commod regard place market purpos direct content direct duli take account intern experi field intern trade commit respect requir cartagena protocol biosafeti convent biolog divers case juli commiss context ratif protocol submit propos implement guidanc implement provis relat definit place market direct provid regulatori committe defin quot genet modifi organ quot purpos direct human be consid organ provis direct prejudic nation legisl field environment liabil commun legisl field complement rule cover liabil type environment damag area european union end commiss undertaken bring forward legisl propos environment liabil end cover damag gmo direct appli organ obtain techniqu genet modif convention number applic long safeti record establish harmonis procedur criteria case case evalu potenti risk aris deliber releas gmo environ case case environment risk assess carri prior releas due account potenti cumul long term effect interact gmo environ establish common methodolog carri environment risk assess base independ scientif advic establish common object monitor gmo deliber releas place market product monitor potenti cumul long term effect consid compulsori part monitor plan member state commiss ensur systemat independ research potenti risk involv deliber releas place market gmo conduct resourc secur research member state commun accord budgetari procedur independ research access relev materi respect intellectu properti right issu antibiot resist gene consider conduct risk assess gmo gene deliber releas gmo research stage case step develop product deriv gmo introduct gmo environ carri quot step step quot principl mean contain gmo reduc scale releas increas gradual step step evalu earlier step term protect human health environ step gmo product intend deliber releas consid place market subject satisfactori field test research develop stage ecosystem affect implement direct carri close liaison implement relev instrument council direct eec juli place plant protect product market context compet author concern implement direct instrument commiss nation level coordin action environment risk assess part risk manag label monitor inform public safeguard claus direct point refer gmo product authoris commun legisl provid specif environment risk assess carri accord principl set annex ii basi inform annex iii prejudic addit requir laid commun legisl mention requir risk manag label monitor inform public safeguard claus equival laid direct end provid cooper commun member state bodi mention direct purpos implement establish commun authoris procedur place market gmo product intend product involv deliber releas organ environ commiss invit conduct studi assess option improv consist effici framework focus centralis authoris procedur place market gmo commun sector legisl monitor requir adapt product concern part direct appli product cover council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product provid includ environment risk assess equival provid direct person undertak deliber releas environ gmo place market gmo product intend product involv deliber releas environ submit notif nation compet author notif technic dossier inform includ full environment risk assess safeti emerg respons case product precis instruct condit propos label packag notif deliber releas gmo carri consent compet author obtain notifi withdraw dossier stage administr procedur laid direct administr procedur end dossier withdrawn reject notif place market gmo product compet author prejudic submiss notif gmo compet author agreement reach end mediat period object remain reject notif confirm neg assess report prejudic futur decis base notif gmo compet author interest smooth function direct member state avail provis exchang inform experi recours safeguard claus direct order ensur presenc gmo product consist genet modifi organ appropri identifi word quot product genet modifi organ quot label accompani document system design committe procedur assign uniqu identifi gmo take account relev develop intern fora ensur traceabl stage place market gmo product authoris part direct introduc direct oblig implement monitor plan order trace identifi direct indirect delai unforeseen effect human health environ gmo product market member state accord treati measur monitor inspect offici servic gmo product market mean sought provid possibl facilit control gmo retriev event sever risk comment public consider draft measur submit regulatori committe compet author give consent satisfi releas safe human health environ administr procedur grant consent place market gmo product made effici transpar time consent grant fix period product consent grant fix period streamlin procedur appli renew consent exist consent grant direct eec renew order avoid dispar consent grant direct pursuant direct order full account condit consent direct renew requir transit period exist consent grant direct eec remain unaffect consent renew revis condit origin consent includ relat monitor time limit consent provis made consult relev scientif committe establish commiss decis ec matter impact human health environ system exchang inform contain notif establish direct eec continu import follow close develop gmo product gmo product market product properli authoris direct member state prohibit restrict imped place market gmo product compli requir direct safeguard procedur provid case risk human health environ commiss european group ethic scienc technolog consult view obtain advic ethic issu gener natur deliber releas place market gmo consult prejudic compet member state ethic issu member state consult committe establish view obtain advic ethic implic biotechnolog measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss inform exchang set direct cover experi gain consider ethic aspect order increas effect implement provis adopt direct provid penalti appli member state includ event releas place market contrari provis direct result neglig report issu year commiss take account inform provid member state separ chapter socioeconom advantag disadvantag categori gmo authoris place market due account interest farmer consum regulatori framework biotechnolog review identifi feasibl improv consist effici framework procedur adapt optimis effici option achiev consid adopt direct part gener provis articl object accord precautionari principl object direct approxim law regul administr provis member state protect human health environ carri deliber releas environ genet modifi organ purpos place market commun place market genet modifi organ product commun articl definit purpos direct quot organ quot mean biolog entiti capabl replic transfer genet materi quot genet modifi organ gmo quot mean organ except human be genet materi alter occur natur mate natur recombin term definit genet modif occur techniqu list annex part techniqu list annex part consid result genet modif quot deliber releas quot mean intent introduct environ gmo combin gmo specif contain measur limit contact provid high level safeti gener popul environ quot place market quot mean make parti return payment free charg oper regard place market make genet modifi microorgan activ regul council direct eec april contain genet modifi microorgan includ cultur collect make gmo microorgan refer indent exclus activ stringent contain measur limit contact provid high level safeti gener popul environ measur base principl contain laid direct eec make gmo exclus deliber releas compli requir laid part direct quot notif quot mean submiss inform requir direct compet author member state quot notifi quot mean person submit notif quot product quot mean prepar consist gmo combin gmo market quot environment risk assess quot mean evalu risk human health environ direct indirect delai deliber releas place market gmo pose carri accord annex ii articl exempt direct appli organ obtain techniqu genet modif list annex direct appli carriag genet modifi organ rail road inland waterwai sea air articl gener oblig member state accord precautionari principl ensur measur avoid advers effect human health environ aris deliber releas place market gmo gmo deliber releas market conform part part person submit notif part part carri environment risk assess inform carri environment risk assess laid annex iii member state commiss ensur gmo gene express resist antibiot medic veterinari treatment consider carri environment risk assess view identifi phase antibiot resist marker gmo advers effect human health environ phase place decemb case gmo market part decemb case gmo authoris part member state commiss ensur potenti advers effect human health environ occur directli indirectli gene transfer gmo organ accur assess case case basi assess conduct accord annex ii take account environment impact natur organ introduc receiv environ member state design compet author author respons compli requir direct compet author examin notif part part complianc requir direct assess provid paragraph member state ensur compet author organis inspect control measur ensur complianc direct event releas gmo place market product authoris member state concern ensur measur termin releas place market initi remedi action inform public commiss member state member state measur ensur traceabl line requir laid annex iv stage place market gmo authoris part part deliber relas gmo purpos place market articl articl appli medicin substanc compund human consist gmo combin gmo provid deliber releas purpos market authoris commun legisl specif environment risk assess accord annex ii basi type inform annex iii prejudic addit requir provid legisl explicit consent prior releas monitor plan accord relev part annex iii view detect effect gmo gmo human health environ manner requir relat treatment item inform inform public inform result releas exchang inform equival contain direct measur accord therewith assess risk environ present substanc compound carri coordin nation commun author mention direct procedur ensur conform specif environment risk assess equival provis direct provid legisl refer direct articl standard authoris procedur prejudic articl person undertak deliber releas gmo combin gmo submit notif compet author member state territori releas place notif refer paragraph includ technic dossier suppli inform annex iii carri environment risk assess deliber releas gmo combin gmo gener inform includ inform personnel train ii inform relat gmo iii inform relat condit releas potenti receiv environ iv inform interact gmo environ plan monitor accord relev part annex iii order identifi effect gmo human health environ vi inform control remedi method wast treatment emerg respons plan vii summari dossier environment risk assess conclus requir annex ii section bibliograph refer indic method notifi refer data result notif previous submit notifi provid inform data result confidenti notifi agreement write submit addit inform consid relev compet author accept releas gmo combin gmo site site purpos defin period notifi singl notif compet author acknowledg date receipt notif consid observ member state made accord articl respond write notifi dai receipt notif indic satisfi notif complianc direct releas proce indic releas fulfil condit direct notif reject purpos calcul dai period refer paragraph account period time compet author await inform request notifi carri public inquiri consult accord articl public inquiri consult prolong dai period refer paragraph dai compet author request inform simultan give reason notifi proce releas receiv written consent compet author conform condit requir consent member state ensur materi deriv gmo deliber releas accord part market accord part articl differenti procedur suffici experi obtain releas gmo ecosystem gmo concern meet criteria set annex compet author submit commiss reason propos applic differenti procedur type gmo initi latest dai receipt compet author propos commiss forward propos compet author dai present observ time make propos public dai make comment consult relev scientif committe dai give opinion decis propos accord procedur laid articl decis establish minimum amount technic inform annex iii evalu forese risk releas inform relat gmo inform relat condit releas potenti receiv environ inform interact gmo environ environment risk assess decis dai date commiss propos receipt compet author propos dai period account period time commiss await observ compet author comment public opinion scientif committe provid paragraph decis paragraph provid notifi proce releas receiv written consent compet author notifi proce releas conform condit requir consent decis paragraph provid releas gmo combin gmo site site purpos defin period notifi singl notif prejudic paragraph commiss decis ec novemb establish simplifi procedur deliber releas environ genet modifi plant pursuant articl council direct eec continu appli member state decid make procedur establish decis accord paragraph releas gmo territori inform commiss thereof articl handl modif inform event modif unintend chang deliber releas gmo combin gmo consequ regard risk human health environ compet author written consent inform risk notif examin compet author member state author written consent notifi immedi measur protect human health environ inform compet author advanc modif unintend chang inform revis measur notif inform compet author refer paragraph signific consequ regard risk human health environ circumst paragraph compet author evalu inform make public requir notifi modifi condit suspend termin deliber releas inform public thereof articl consult inform public member state prejudic provis articl consult public group propos deliber releas member state lai arrang consult includ reason time period order give public group opportun express opinion prejudic provis articl member state make public inform part releas gmo territori commiss make public inform contain system exchang inform pursuant articl articl report notifi releas complet releas interv laid consent basi result environment risk assess notifi send compet author result releas respect risk human health environ refer kind product notifi intend notifi stage format present result establish accord procedur laid articl articl exchang inform compet author commiss commiss set system exchang inform contain notif compet author send commiss dai receipt summari notif receiv articl format summari establish modifi accord procedur laid articl commiss latest dai receipt forward summari member state dai present observ commiss directli request member state permit receiv copi full notif compet author relev member state compet author inform commiss final decis complianc articl includ relev reason reject notif result releas receiv accord articl releas gmo refer articl year member state send list gmo releas territori list notif reject commiss forward compet author member state part place market gmo product articl sector legisl articl appli gmo product authoris commun legisl specif environment risk assess carri accord principl set annex ii basi inform annex iii prejudic addit requir provid commun legisl mention requir risk manag label monitor inform public safeguard claus equival laid direct council regul eec concern articl direct appli gmo product authoris regul provid specif environment risk assess carri accord principl set annex ii direct basi type inform annex iii direct prejudic relev requir risk assess risk manag label monitor inform public safeguard claus provid commun legisl medicin product human veterinari procedur ensur risk assess requir risk manag label monitor inform public safeguard claus equival laid direct introduc regul european parliament council futur sector legisl base provis regul make refer direct regul enter forc gmo product authoris commun legisl market accept place market accord direct evalu request place market gmo refer paragraph bodi establish commun direct member state purpos implement direct consult articl notif procedur gmo combin gmo product market notif submit compet author member state gmo market time compet author acknowledg date receipt notif immedi forward summari dossier refer paragraph compet author member state commiss compet author delai examin notif accord paragraph notifi addit inform notif accord paragraph latest send assess report accord articl compet author forward copi notif commiss dai receipt forward compet author member state notif inform requir annex iii iv inform account divers site gmo product includ inform data result obtain research development releas impact releas human health environ environment risk assess conclus requir annex ii section condit place market product includ specif condit handl refer articl propos period consent exce ten year plan monitor accord annex vii includ propos time period monitor plan time period propos period consent propos label compli requir laid annex iv label state gmo present word quot product genet modifi organ quot label accompani document propos packag compris requir laid annex iv summari dossier format summari establish accord procedur laid articl basi result releas notifi part substant reason scientif ground notifi consid place market gmo product pose risk human health environ propos compet author provid part inform requir annex iv section notifi includ notif inform data result releas gmo combin gmo previous notifi carri notifi insid commun notifi refer data result notif previous submit notifi submit addit inform consid relev provid inform data result confidenti notifi agreement write order gmo combin gmo purpos notif separ notif submit inform regard risk gmo human health environ written consent grant notifi immedi measur protect human health environ inform compet author thereof addit notifi revis inform condit notif articl assess report receipt acknowledg notif accord articl compet author examin complianc direct dai receipt notif compet author prepar assess report send notifi subsequ withdraw notifi prejudic submiss notif compet author case refer paragraph send report inform refer paragraph inform base report commiss dai receipt forward compet author member state case refer paragraph compet author send report inform refer paragraph inform base report commiss earlier dai send assess report notifi dai receipt notif commiss dai receipt forward report compet author member state assess report gmo question market condit gmo question market assess report establish accord guidelin laid annex vi purpos calcul dai period refer paragraph period time compet author await inform request notifi account compet author state reason request inform articl standard procedur case refer articl compet author commiss inform make comment present reason object place market gmo question period dai date circul assess report comment reason object repli forward commiss immedi circul compet author compet author commiss discuss outstand issu aim arriv agreement dai date circul assess report period time inform notifi await account purpos calcul final dai period arriv agreement reason state request inform case refer articl compet author prepar report decid gmo market notif reject decis state reason compet author prepar report decid product market absenc reason object member state commiss dai date circul assess report refer articl outstand issu resolv dai period refer paragraph compet author prepar report give consent write place market transmit notifi inform member state commiss thereof dai consent maximum period ten year start date consent issu purpos approv gmo progeni gmo intend market seed relev commun provis period consent end latest ten year date inclus plant varieti gmo offici nation catalogu plant varieti accord council direct eec eec case forest reproduct materi period consent end latest ten year date inclus basic materi gmo offici nation regist basic materi accord council direct ec articl criteria inform gmo compet author commiss initi make propos criteria inform requir met notif derog articl place market type gmo product criteria inform requir requir summari adopt consult relev scientif committe accord procedur laid articl criteria inform requir ensur high level safeti human health environ base scientif evid safeti experi gain releas compar gmo requir set articl replac adopt procedur set articl articl appli procedur laid articl decis criteria inform requir refer paragraph initi commiss make propos public public make comment commiss dai commiss forward comment analysi committe set pursuant articl articl renew consent derog articl procedur set paragraph appli renew consent grant part octob consent grant direct eec place market gmo product octob latest month expiri consent consent refer paragraph octob consent refer paragraph notifi articl submit notif compet author receiv origin notif copi consent place market gmo report result monitor carri articl case consent refer paragraph report submit monitor carri inform regard risk product human health environ propos amend complement condit origin consent inter alia condit futur monitor time limit consent compet author acknowledg date receipt notif notif accord paragraph delai forward copi notif assess report commiss dai receipt forward compet author member state send assess report notifi assess report gmo remain market condit gmo remain market compet author commiss inform make comment present reason object period dai date circul assess report comment reason object repli forward commiss immedi circul compet author case paragraph absenc reason object member state commiss dai date circul assess report compet author prepar report transmit notifi final decis write inform member state commiss thereof dai valid consent gener rule exce ten year limit extend specif reason compet author commiss discuss outstand issu aim arriv agreement dai date circul assess report outstand issu resolv dai period refer paragraph compet author prepar report transmit notifi final decis write inform member state commiss thereof dai valid consent limit notif renew consent accord paragraph notifi continu place gmo market condit consent final decis notif articl commun procedur case object case object rais maintain compet author commiss accord articl decis adopt publish dai accord procedur laid articl decis inform articl purpos calcul dai period period time commiss await inform request notifi seek opinion scientif committe consult accord articl account commiss state reason request inform inform compet author request notifi period time commiss await opinion scientif committe exce dai period time council take act accord procedur laid articl account favour decis compet author prepar report give consent write place market renew consent transmit notifi inform member state commiss thereof dai public notif decis articl consent prejudic requir commun legisl written consent place market gmo product product notif commun specif condit environ geograph area stipul condit strictli adher notifi proce place market receiv written consent compet author accord articl conform condit requir consent written consent refer articl case explicitli scope consent includ ident gmo market product uniqu identifi period valid consent condit place market product includ specif condit handl packag gmo product condit protect ecosystem environ geograph area prejudic articl notifi make control sampl compet author request label requir complianc requir laid annex iv label state gmo present word quot product genet modifi organ quot label document accompani product product gmo monitor requir accord annex vii includ oblig report commiss compet author time period monitor plan oblig person sell product user inter alia case gmo grown level inform deem locat member state measur ensur written consent decis refer articl applic made access public condit written consent decis applic compli articl monitor handl inform place market gmo product notifi ensur monitor report carri condit consent report monitor submit commiss compet author member state basi report accord consent framework monitor plan consent compet author receiv origin notif adapt monitor plan monitor period inform user sourc regard risk gmo human health environ written consent notifi immedi measur protect human health environ inform compet author thereof addit notifi revis inform condit notif inform compet author consequ risk gmo human health environ circumst paragraph immedi forward inform commiss compet author member state avail provis articl inform written consent inform consent compet author dai receipt inform forward assess report indic condit consent amend consent termin commiss dai receipt forward compet author member state comment reason object place market gmo propos amend condit consent dai circul assess report forward commiss immedi forward compet author compet author commiss discuss outstand issu aim arriv agreement dai date circul assess report absenc reason object member state commiss dai date circul inform outstand issu resolv dai compet author prepar report amend consent propos transmit amend consent notifi inform member state commiss thereof dai ensur transpar result monitor carri part direct made publicli articl label member state measur ensur stage place market label packag gmo market product compli relev requir written consent refer articl product adventiti technic unavoid trace authoris gmo exclud minimum threshold establish product label provis paragraph threshold level establish product concern procedur laid articl articl free circul prejudic articl member state prohibit restrict imped place market gmo product compli requir direct articl safeguard claus member state result addit inform made date consent affect environment risk assess reassess exist inform basi addit scientif knowledg detail ground gmo product properli notifi receiv written consent direct constitut risk human health environ member state provision restrict prohibit sale gmo product territori member state ensur event sever risk emerg measur suspens termin place market appli includ inform public member state immedi inform commiss member state action articl give reason decis suppli review environment risk assess indic condit consent amend consent termin addit inform decis base decis matter dai accord procedur laid articl purpos calcul dai period period time commiss await inform request notifi seek opinion scientif committe consult account period time commiss await opinion scientif committe consult exce dai likewis period time council take act accord procedur laid articl account articl inform public prejudic articl receipt notif accord articl commiss immedi make public summari refer articl commiss make public assess report case refer articl public make comment commiss dai commiss immedi forward comment compet author prejudic articl gmo receiv written consent place market place market reject product direct assess report carri gmo opinion scientif committe consult made public product gmo gmo contain part final provis articl confidenti commiss compet author divulg parti confidenti inform notifi exchang direct protect intellectu properti right relat data receiv notifi inform notif submit direct disclosur harm competit positionand treat confidenti verifi justif case compet author consult notifi decid inform confidenti inform notifi decis case inform submit articl confidenti gener descript gmo gmo address notifi purpos releas locat releas intend method plan monitor gmo gmo emerg respons environment risk assess reason notifi withdraw notif compet author commiss respect confidenti inform suppli articl label gmo refer articl subparagraph gmo made oper refer articl subparagraph subject adequ label requir accord relev section annex iv order provid clear inform label accompani document presenc gmo effect word quot product genet modifi organ quot label accompani document condit implement paragraph duplic creat inconsist exist label provis laid exist commun legisl determin accord procedur laid articl account label provis establish member state accord commun legisl articl adapt annex technic progress section annex ii annex iii vi section annex vii adapt technic progress accord procedur laid articl articl consult scientif committe case object risk gmo human health environ rais compet author commiss maintain accord articl assess report refer articl gmo market relev scientif committe consult commiss initi request member state object relev scientif committe consult commiss initi request member state matter direct advers effect human health environ administr procedur laid direct affect paragraph articl consult committe ethic prejudic compet member state ethic issu commiss initi request european parliament council consult committe creat view obtain advic ethic implic biotechnolog european group ethic scienc technolog ethic issu gener natur consult place request member state consult conduct clear rule open transpar public access outcom access public administr procedur provid direct affect paragraph articl committe procedur commiss assist committe refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month committe adopt rule procedur articl exchang inform report member state commiss meet regularli exchang inform experi acquir regard prevent risk relat releas place market gmo inform exchang cover experi gain implement articl subparagraph environment risk assess monitor issu consult inform public guidanc implement articl subparagraph provid committe establish articl commiss establish regist purpos record inform genet modif gmo mention point annex iv prejudic articl regist includ part access public detail arrang oper regist decid accord procedur laid articl prejudic paragraph point annex iv member state establish public regist locat releas gmo part record member state establish regist record locat gmo grown part inter alia effect gmo environ monitor accord provis articl prejudic provis articl locat notifi compet author made public manner deem compet author accord nation provis year member state send commiss report measur implement provis direct report includ factual report experi gmo market product direct year commiss publish summari base report refer paragraph commiss send european parliament council year report experi member state gmo market direct submit report commiss time submit specif report oper part part includ assess implic account divers european ecosystem complement regulatori framework field feasibl option improv consist effici framework includ centralis commun authoris procedur arrang final decis make commiss suffici experi accumul implement part differenti procedur justifi provis implicit consent procedur part justifi applic differenti procedur socioeconom implic deliber releas place market gmo commiss send european parliament council year report ethic issu refer articl report accompani propos view amend direct articl implement cartagena protocol biosafeti commiss invit bring forward case juli legisl propos implement detail cartagena protocol biosafeti propos complement amend provis direct propos includ measur implement procedur laid cartagena protocol accord protocol requir commun export ensur requir advanc inform agreement procedur set articl cartagena protocol fulfil articl penalti member state determin penalti applic breach nation provis adopt pursuant direct penalti effect proportion dissuas articl transposit member state bring forc law regul administr provis compli direct octob forthwith inform commiss thereof member state adopt measur refer direct accompani refer occas offici public method make refer laid member state member state commun commiss text main provis domest law adopt field cover direct articl pend notif notif place market gmo product receiv pursuant direct eec respect procedur direct complet octob subject provis direct januari notifi complement notif accord direct articl repeal direct eec repeal octob refer made repeal direct constru made direct read accord correl tabl annex viii articl direct enter forc dai public offici journal european commun articl direct address member state brussel march european parliament fontain presid council pagrotski presid oj oj opinion european parliament februari oj council common posit decemb oj decis european parliament april oj decis european parliament februari decis council februari oj direct amend commiss direct ec oj oj direct amend commiss direct ec oj oj regul amend commiss regul ec oj oj oj oj direct amend direct ec oj oj council direct eec septemb common catalogu varieti agricultur plant speci oj direct amend direct ec oj council direct eec septemb market veget seed oj direct amend direct ec council direct ec decemb market forest reproduct materi oj annex techniqu refer articl part techniqu genet modif refer articl inter alia recombin nucleic acid techniqu involv format combin genet materi insert nucleic acid molecul produc mean organ viru bacteri plasmid vector system incorpor host organ natur occur capabl continu propag techniqu involv direct introduct organ herit materi prepar organ includ micro inject macro inject micro encapsul cell fusion includ protoplast fusion hybridis techniqu live cell combin herit genet materi form fusion cell mean method occur natur part techniqu refer articl consid result genet modif condit involv recombin nucleic acid molecul genet modifi organ made techniqu method exclud annex vitro fertilis natur process conjug transduct transform polyploidi induct annex techniqu refer articl techniqu method genet modif yield organ exclud direct condit involv recombin nucleic acid molecul genet modifi organ produc techniqu method list mutagenesi cell fusion includ protoplast fusion plant cell organ exchang genet materi tradit breed method annex ii principl environment risk assess annex describ gener term object achiev element consid gener principl methodolog perform environment risk assess refer articl supplement guidanc note develop accord procedur laid articl guidanc note complet octob view contribut common understand term quot direct indirect delai quot implement annex prejudic guidanc respect extent indirect effect account term quot direct effect quot refer primari effect human health environ result gmo occur causal chain event quot indirect effect quot refer effect human health environ occur causal chain event mechan interact organ transfer genet materi manag observ indirect effect delai quot effect quot refer effect human health environ observ period releas gmo effect direct indirect quot delai effect quot refer effect human health environ observ period releas gmo appar direct indirect effect stage termin releas gener principl environment risk assess analysi quot cumul long term effect quot relev releas place market carri quot cumul long term effect quot refer accumul effect consent human health environ includ inter alia flora fauna soil fertil soil degrad organ materi feed food chain biolog divers anim health resist problem relat antibiot object object case case basi identifi evalu potenti advers effect gmo direct indirect delai human health environ deliber releas place market gmo conduct view identifi risk manag method gener principl accord precautionari principl gener principl perform identifi characterist gmo potenti advers effect compar present modifi organ deriv situat carri scientif sound transpar manner base scientif technic data carri case case basi mean requir inform vari depend type gmo concern intend potenti receiv environ take account gmo environ inform gmo effect human health environ readdress order determin risk chang determin amend risk manag methodolog characterist gmo releas depend case account relev technic scientif detail characterist recipi parent organ genet modif inclus delet genet materi relev inform vector donor gmo intend releas includ scale potenti receiv environ interact inform releas similar organ organ similar trait interact similar environ assist step draw conclus refer articl point address identif characterist advers effect characterist gmo link genet modif result advers effect human health environ identifi comparison characterist gmo modifi organ condit releas assist identifi potenti advers effect aris genet modif import discount potenti advers effect basi occur potenti advers effect gmo vari case case includ diseas human includ allergen toxic effect item ii ii annex iii annex iii diseas anim plant includ toxic allergen effect item ii ii annex iii annex iii effect dynam popul speci receiv environ genet divers popul item iv annex iii alter suscept pathogen facilit dissemin infecti diseas creat reservoir vector compromis prophylact therapeut medic veterinari plant protect treatment transfer gene confer resist antibiot human veterinari medicin item ii ii iv annex iii effect biogeochemistri biogeochem cycl carbon nitrogen recycl soil decomposit organ materi item ii iv annex iii annex iii advers effect occur directli indirectli mechan includ spread gmo environ transfer insert genet materi organ organ genet modifi phenotyp genet instabl interact organ manag includ applic agricultur practic evalu potenti consequ advers effect occur magnitud consequ potenti advers effect evalu evalu assum advers effect occur magnitud consequ influenc environ gmo intend releas manner releas evalu likelihood occurr identifi potenti advers effect major factor evalu likelihood probabl advers effect occur characterist environ gmo intend releas manner releas estim risk pose identifi characterist gmo estim risk human health environ pose identifi characterist gmo potenti advers effect made state art combin likelihood advers effect occur magnitud consequ occur applic manag strategi risk deliber releas market gmo risk assess identifi risk requir manag manag risk manag strategi defin determin risk gmo evalu risk gmo made take account risk manag strategi propos conclus potenti environment impact releas place market gmo basi carri accord principl methodolog outlin section inform point list section includ notif view assist draw conclus potenti environment impact releas place market gmo case gmo higher plant likelihood gmo persist invas natur habitat condit propos releas select advantag disadvantag confer gmo likelihood realis condit propos releas potenti gene transfer speci condit propos releas gmo select advantag disadvantag confer speci potenti delai environment impact direct indirect interact gmo target organ applic potenti delai environment impact direct indirect interact gmo target organ includ impact popul level competitor prei host symbiont predat parasit pathogen delai effect human health result potenti direct indirect interact gmo person work come contact vicin gmo releas delai effect anim health consequ feed food chain result consumpt gmo product deriv intend anim feed delai effect biogeochem process result potenti direct indirect interact gmo target target organ vicin gmo releas delai direct indirect environment impact specif techniqu manag gmo gmo case genet modifi higher plant gmhp likelihood gmhp persist recipi parent plant agricultur habitat invas natur habitat select advantag disadvantag confer gmhp potenti gene transfer sexual compat plant speci condit plant gmhp select advantag disadvantag confer plant speci potenti delai environment impact result direct indirect interact gmhp target organ predat parasitoid pathogen applic delai environment impact result direct indirect interact gmhp target organ take account organ interact target organ includ impact popul level competitor herbivor symbiont applic parasit pathogen delai effect human health result potenti direct indirect interact gmhp person work come contact vicin gmhp releas delai effect anim health consequ feed food chain result consumpt gmo product deriv intend anim feed delai effect biogeochem process result potenti direct indirect interact gmo target target organ vicin gmo releas delai direct indirect environment impact specif cultiv manag harvest techniqu gmhp gmhp annex iii inform requir notif notif refer part part direct includ inform set annex point includ appli case expect individu notif address subset consider individu situat level detail requir respons subset consider vari natur scale propos releas futur develop genet modif necessit adapt annex technic progress develop guidanc note annex differenti inform requir type gmo singl cell organ fish insect gmo develop vaccin suffici experi notif releas gmo gain commun descript method refer standardis internation recognis method mention dossier bodi bodi respons carri studi annex iii appli releas type genet modifi organ higher plant annex iii appli releas genet modifi higher plant term quot higher plant quot mean plant belong taxonom group spermatophyta gymnosperma angiosperma annex iii inform requir notif releas genet modifi organ higher plant gener inform address notifi compani institut qualif experi respons scientist titl project ii inform relat gmo characterist donor recipi parent organ scientif taxonomi name usual strain phenotyp genet marker degre related donor recipi parent organ descript identif detect techniqu sensit reliabl quantit term specif detect identif techniqu descript geograph distribut natur habitat organ includ inform natur predat prei parasit competitor symbiont host organ transfer genet materi occur natur condit verif genet stabil organ factor affect patholog ecolog physiolog trait classif hazard exist commun rule protect human health environ gener time natur ecosystem sexual asexu reproduct cycl inform surviv includ season abil form surviv structur pathogen infect toxigen virul allergen carrier vector pathogen vector host rang includ target organ activ latent virus provirus abil colonis organ antibiot resist potenti antibiot human domest organ prophylaxi therapi involv environment process primari product nutrient turnov decomposit organ matter respir natur indigen vector sequenc frequenc mobilis specif presenc gene confer resist histori previou genet modif characterist vector natur sourc vector sequenc transposon vector code genet segment construct gmo make introduc vector insert function gmo frequenc mobilis insert vector genet transfer capabl method determin inform degre vector limit dna requir perform intend function characterist modifi organ inform relat genet modif method modif method construct introduc insert recipi delet sequenc descript insert vector construct puriti insert unknown sequenc inform degre insert sequenc limit dna requir perform intend function method criteria select sequenc function ident locat alter insert delet nucleic acid segment question refer harm sequenc inform final gmo descript genet trait phenotyp characterist trait characterist express longer express structur amount vector donor nucleic acid remain final construct modifi organ stabil organ term genet trait rate level express genet materi method sensit measur activ express protein descript identif detect techniqu includ techniqu identif detect insert sequenc vector sensit reliabl quantit term specif detect identif techniqu histori previou releas gmo consider human health anim health plant health toxic allergen effect gmo metabol product ii comparison modifi organ donor recipi parent organ pathogen iii capac colonis iv organ pathogen human immunocompet diseas caus mechan pathogen includ invas virul communic infect dose host rang possibl alter possibl surviv human host presenc vector mean dissemin biolog stabil antibiot resist pattern allergen avail therapi product hazard iii inform relat condit releas receiv environ inform releas descript propos deliber releas includ purpos foreseen product foreseen date releas time plan experi includ frequenc durat releas prepar site previou releas size site method releas quantiti gmo releas disturb site type method cultiv mine irrig activ worker protect measur releas post releas treatment site techniqu foreseen elimin inactiv gmo end experi inform result previou releas gmo scale ecosystem inform environ site wider environ geograph locat grid refer site case notif part site releas foreseen area product physic biolog proxim human signific biota proxim signific biotop protect area drink water suppli climat characterist region affect geograph geolog pedolog characterist flora fauna includ crop livestock migratori speci descript target target ecosystem affect comparison natur habitat recipi organ propos site releas plan develop land region influenc environment impact releas iv inform relat interact gmo environ characterist affect surviv multipl dissemin biolog featur affect surviv multipl dispers predict environment condit affect surviv multipl dissemin wind water soil temperatur ph sensit specif agent interact environ predict habitat gmo studi behaviour characterist gmo ecolog impact carri simul natur environ microcosm growth room greenhous genet transfer capabl postreleas transfer genet materi gmo organ affect ecosystem postreleas transfer genet materi indigen organ gmo likelihood postreleas select lead express unexpect undesir trait modifi organ measur emploi ensur verifi genet stabil descript genet trait prevent minimis dispers genet materi method verifi genet stabil rout biolog dispers potenti mode interact dissemin agent includ inhal ingest surfac contact burrow descript ecosystem gmo dissemin potenti excess popul increas environ competit advantag gmo relat unmodifi recipi parent organ identif descript target organ applic anticip mechan result interact releas gmo target organ applic identif descript target organ advers affect releas gmo anticip mechan identifi advers interact likelihood postreleas shift biolog interact host rang predict interact target organ environ includ competitor prei host symbiont predat parasit pathogen predict involv biogeochem process potenti interact environ inform monitor control wast treatment emerg respons plan monitor techniqu method trace gmo monitor effect specif identifi gmo distinguish donor recipi parent organ sensit reliabl monitor techniqu techniqu detect transfer donat genet materi organ durat frequenc monitor control releas method procedur avoid minimis spread gmo site releas design area method procedur protect site intrus unauthoris individu method procedur prevent organ enter site wast treatment type wast gener expect amount wast descript treatment envisag emerg respons plan method procedur control gmo case unexpect spread method decontamin area affect erad gmo method dispos sanit plant anim soil expos spread method isol area affect spread plan protect human health environ case occurr undesir effect annex iii inform requir notif releas genet modifi higher plant gmhp gymnosperma angiosperma gener inform address notifi compani institut qualif experi respons scientist titl project inform relat recipi parent plant complet famili genu speci subspeci cultivar breed line common inform reproduct mode reproduct ii specif factor affect reproduct iii gener time sexual compat cultiv wild plant speci includ distribut europ compat speci surviv abil form structur surviv dormanc specif factor affect surviv dissemin wai extent estim viabl pollen seed declin distanc dissemin specif factor affect dissemin geograph distribut plant case plant speci grown member state descript natur habitat plant includ inform natur predat parasit competitor symbiont potenti interact relev gmo plant organ ecosystem grown includ inform toxic effect human anim organ inform relat genet modif descript method genet modif natur sourc vector size sourc donor organ intend function constitu fragment region intend insert inform relat genet modifi plant descript trait characterist introduc modifi inform sequenc insert delet size structur insert method characteris includ inform part vector introduc gmhp carrier foreign dna remain gmhp case delet size function delet region copi number insert locat insert plant cell integr chromosom chloroplast mitochondria maintain integr form method determin inform express insert inform development express insert lifecycl plant method characteris part plant insert express root stem pollen inform genet modifi plant differ recipi plant mode rate reproduct dissemin surviv genet stabil insert phenotyp stabil gmhp chang abil gmhp transfer genet materi organ inform toxic allergen harm effect human health aris genet modif inform safeti gmhp anim health toxic allergen harm effect aris genet modif gmhp intend anim feedstuff mechan interact genet modifi plant target organ applic potenti interact gmhp target organ result genet modif potenti interact abiot environ descript detect identif techniqu genet modifi plant inform previou releas genet modifi plant applic inform relat site releas notif submit pursuant articl locat size releas site descript releas site ecosystem includ climat flora fauna presenc sexual compat wild rel cultiv plant speci proxim offici recognis biotop protect area affect inform relat releas notif submit pursuant articl purpos releas foreseen date durat releas method genet modifi plant releas method prepar manag releas site prior postreleas includ cultiv practic harvest method approxim number plant plant inform control monitor postreleas wast treatment plan notif submit pursuant articl precaut distanc sexual compat plant speci wild rel crop measur minimis prevent dispers reproduct organ gmhp pollen seed tuber descript method postreleas treatment site descript postreleas treatment method genet modifi plant materi includ wast descript monitor plan techniqu descript emerg plan method procedur protect site annex iv addit inform annex describ gener term addit inform provid case notif place market inform label requir gmo product market gmo exempt articl subparagraph supplement guidanc note descript product intend develop accord procedur laid articl label exempt organ requir articl met provid recommend restrict inform provid notif place market gmo product addit annex iii propos commerci name product name gmo contain specif identif code notifi identifi gmo consent commerci name provid compet author full address person establish commun respons place market manufactur import distributor full address supplier control sampl descript product gmo product intend differ manag gmo compar similar genet modifi product highlight descript geograph area type environ product intend commun includ estim scale area intend categori user product industri agricultur skill trade consum public larg inform genet modif purpos place regist modif organ detect identif gmo product facilit post market control inspect inform includ lodg sampl gmo genet materi compet author detail nucleotid sequenc type inform identifi gmo product progeni methodolog detect identifi gmo product includ experiment data demonstr specif methodolog inform confidenti reason publicli access part regist identifi propos label label accompani document includ summaris form commerci product statement quot product genet modifi organ quot gmo inform refer point label access inform publicli access part regist inform provid notif relev addit point accord articl direct measur case unintend releas misus specif instruct recommend storag handl specif instruct carri monitor report notifi requir compet author compet author effect inform advers effect instruct consist annex vii part propos restrict approv gmo product purpos propos packag estim product import commun propos addit label includ summaris form inform refer point annex criteria applic differenti procedur articl criteria refer articl set taxonom statu biologi mode reproduct pollin abil cross relat speci pathogenec modifi recipi organ suffici knowledg safeti human health environ parent recipi organ environ releas inform interact relev risk assess involv parent recipi organ organ experiment releas ecosystem inform demonstr insert genet materi characteris inform construct vector system sequenc genet materi carrier dna genet modif involv delet genet materi extent delet suffici inform genet modif enabl identif gmo progeni releas gmo present addit increas risk human health environ condit experiment releas present releas parent recipi organ capac spread environ invad unrel ecosystem capac transfer genet materi organ environ result advers effect annex vi guidelin assess report assess report provid articl includ identif characterist recipi organ relev assess gmo question identif risk human health environ result releas environ recipi modifi organ descript result genet modif modifi organ assess genet modif characteris suffici purpos evalu risk human health environ identif risk human health environ aris releas gmo question compar releas modifi organ base environment risk assess carri accord annex ii conclus gmo question market product condit gmo question market view compet author commiss sought specif issu aspect conclus address propos risk manag monitor plan propos case conclud gmo market compet author give reason conclus annex vii monitor plan annex describ gener term object achiev gener principl design monitor plan refer articl supplement guidanc note develop accord procedur laid articl guidanc note complet octob object object monitor plan confirm assumpt occurr impact potenti advers effect gmo correct identifi occurr advers effect gmo human health environ anticip gener principl monitor refer articl take place consent place gmo market interpret data collect monitor consid light exist environment condit activ environ observ assess consid establish consequ gmo result environment factor place gmo market experi data gain monitor experiment releas gmo assist design post market monitor regim requir place market gmo product design monitor plan design monitor plan detail case case basi take account account characterist gmo characterist scale intend rang relev environment condit gmo expect releas incorpor gener surveil unanticip advers effect case specif monitor focus advers effect identifi case specif monitor carri suffici time period detect direct delai indirect effect identifi surveil make establish routin surveil practic monitor agricultur cultivar plant protect veterinari medic product explan relev inform collect establish routin surveil practic made consent holder provid facilit observ systemat manner releas gmo receiv environ interpret observ respect safeti human health environ identifi notifi user carri task monitor plan requir respons ensur monitor plan set place carri appropri ensur rout consent holder compet author inform observ advers effect human health environ time point interv report result monitor give consider mechan identifi confirm observ advers effect human health environ enabl consent holder compet author measur protect human health environ annex viii correl tabl gt tabl gt commiss declar articl amend commiss note agreement legisl relat recit articl basi amend date propos present implement cartagena protocol content propos respect initi commiss state accept bound provis articl time content futur propos commiss confirm commit comprehens examin potenti implic present propos view full implement cartagena protocol commiss declar respect amend view facilit oblig member state measur ensur traceabl label stage place market gmo authoris accord part revis direct eec commiss reaffirm intent present year propos purpos addit commiss time regard result meet expert member state novemb affirm intent present propos aim provid traceabl product deriv gmo supplement label regim accord white paper food safeti