commiss decis juli establish guidanc note supplement annex ii direct ec european parliament council deliber releas environ genet modifi organ repeal council direct eec notifi document number text eea relev ec commiss european commun regard treati establish european commun regard direct ec european parliament council march deliber releas environ genet modifi organ repeal council direct eec paragraph annex ii thereto direct ec member state commiss ensur potenti advers effect human health environ occur directli indirectli gene transfer genet modifi organ hereinaft gmo organ accur assess case case basi accord annex ii direct articl articl direct ec notif releas place market gmo includ environment risk assess conclus potenti environment impact releas place market gmo accord annex ii direct annex ii direct ec supplement note provid detail guidanc object element gener principl methodolog environment risk assess refer annex measur provid decis accord opinion committe establish articl direct ec adopt decis articl guidanc note set annex decis supplement annex ii direct ec articl decis address member state brussel juli commiss margot wallström member commiss oj annex guidanc note object element gener principl methodolog environment risk assess refer annex ii direct ec introduct environment risk assess era defin articl direct ec quot evalu risk human health environ direct indirect delai deliber releas place market gmo pose quot gener oblig direct articl requir member state commiss ensur potenti advers effect human health environ occur directli indirectli accur assess case case basi take account environment impact natur organ introduc receiv environ era carri accord annex ii direct refer part thereof annex ii describ gener term object achiev element consid gener principl methodolog perform era take account impact human health environ natur organ introduc receiv environ notifi submit notif includ era deliber releas articl place market articl guidanc note supplement annex ii direct ec outlin object principl methodolog era order assist notifi facilit perform compet author comprehens era direct ec make process era transpar gener public step era set chapter object accord annex ii direct ec object era case case basi identifi evalu potenti advers effect gmo direct indirect delai human health environ deliber releas place market gmo era conduct view identifi risk manag method era cover deliber releas part place market part refer direct ec place market necessarili includ deliber releas environ intent introduct market agricultur product consist gmo food feed process case era includ notif process gener differ era deliber releas place market due differ exist data time scale area addit guidanc note cover gmo includ microorgan plant anim gmo deliber releas market higher plant chang futur era serv basi identifi risk manag method focus monitor chapter case case assess cover gmo concern gmo gmo assess environ gmo releas site site assess region region assess applic futur develop genet modif make adapt annex ii guidanc note technic progress differenti inform requir type gmo singl cell organ fish insect gmo develop vaccin suffici experi notif releas gmo commun annex iii fourth paragraph chapter risk assess antibiot resist marker gene specif issu guidanc item recommend quot effect categori quot gmo human health environ annex ii direct ec interest common interpret definit direct term illustr quot direct effect quot refer primari effect human health environ result gmo occur causal chain event direct effect bt toxin target organ pathogen effect gm microorgan human health quot indirect effect quot refer effect human health environ occur causal chain event mechan interact organ transfer genet materi manag observ indirect effect delai reduc target popul insect affect popul insect develop multipl resist system effect requir assess long term interact indirect effect reduct usag pesticid quot effect quot refer effect human health environ observ period releas gmo effect direct indirect death insect forag transgen plant pest resist trait induct allergi suscept human due exposur gmo quot delai effect quot refer effect human health environ observ period releas gmo appar direct indirect effect stage termin releas establish invas behaviour gmo gener deliber releas import gmo live long time genet modifi tree speci hybrid close rel transgen crop invas natur ecosystem delai effect difficult determin appar long term measur monitor detect effect gener principl accord precautionari principl era base gener principl identifi characterist gmo potenti advers effect compar present modifi organ deriv situat baselin receiv environ includ organ interact variat determin harm characterist gmo identifi baselin serv point refer futur compar case veget propag crop compar analysi includ parent speci gener transgen line case crop reproduc sexual compar includ isogen line crop develop back cross import case substanti equival test control simpli reli comparison origin parent materi exist data suffici baselin defin refer comparison baselin depend consider extent receiv environ includ biotic abiot factor natur preserv habitat agricultur farmland contamin land combin environ era carri scientif sound transpar manner base scientif technic data evalu potenti advers effect base scientif technic data common methodolog identif gather interpret relev data data measur test addit scientif sound model procedur provid miss data era era account uncertainti level scientif uncertainti result characterist scientif method variabl chosen measur made sampl model causal relationship emploi scientif uncertainti aris controversi exist data lack relev data uncertainti relat qualit quantit element analysi level knowledg data baselin reflect level uncertainti provid notifi assess uncertainti includ lack data knowledg gap standard deviat complex comparison scientif uncertainti current practic era result definit answer question consid lack data potenti long term effect avail data low case risk manag safeguard consid accord precautionari principl order prevent advers effect human health environ gener principl era includ result adequ research potenti risk involv deliber releas place market gmo document compar experi step step approach step begin experi contain system deliber releas place market data step collect earli procedur simul environment condit contain system give result relev deliber releas behaviour microorgan simul microcosm behaviour plant simul greenhous extent gmo market relev data deliber releas provid type environ gmo era carri case case basi mean requir inform vari depend type gmo concern intend potenti receiv environ take account inter alia gmo environ era case case principl broad rang individu characterist organ gmo gmo environ site site region region huge varieti environment effect genet modifi microorgan small size unknown interact plant higher plant food feed tree potenti longev anim insect small size high potenti overcom barrier saltwat fish high distribut potenti broad rang environment characterist site specif region specif account support case case assess classifi region data habitat area reflect aspect receiv environ relev gmo botan data occurr wild rel gmo plant agricultur natur habitat europ notifi account potenti harm interact gmo relev gmo deliber releas market past includ repeat releas gmo plant protect product repeat releas compar occasion releas time high background level gmo perman environ inform gmo effect human health environ era address order determin risk chang determin amend risk manag case inform irrespect measur era assess chang term authoris gmo releas place market adjust risk manag measur chapter inform aris research monitor plan relev experi era monitor close link era basi monitor plan focu advers effect human health environ requir monitor plan deliber releas gmo part accord relev part annex iii place market gmo part accord annex vii part monitor includ gener surveil plai import role provid data long term potenti advers effect gmo monitor result confirm era lead evalu era gener principl era 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 flora fauna soil fertil soil degrad organ materi feed food chain biolog divers anim health resist problem relat antibiot potenti cumul long term effect era account issu long term interact gmo receiv environ characterist gmo import long term basi repeat deliber releas place market long period gmo deliber releas market past inform requir long term effect instanc multipl herbicid resist adequ research partli framework monitor plan provid import data assess cumul long term effect guidanc item recommend methodolog characterist gmo releas era 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 era prior deliber releas gmo combin gmo part place market part direct notif includ inform set annex iiia iiib direct inform gmo donor recipi vector condit releas environ interact gmo environ monitor gmo submit compet author member state releas place market place time notif technic dossier inform includ full era accord articl articl direct amount detail need substanti point depend import era notifi provid bibliograph refer method inform recipi donor vector genet modif gmo basi inform request annex iiia iiib direct independ environ gmo experiment releas market condit experiment releas market inform basi identifi potenti harm characterist potenti hazard gmo knowledg experi gain releas similar gmo provid import inform potenti hazard releas question inform intend releas receiv environ interact request annex iiia iiib direct relat environ gmo releas condit includ scale releas inform determin extent potenti harm characterist gmo step analysi era draw conclus era refer articl direct ec point address main step era gt pic file quot en tif quot gt quot hazard quot harm characterist defin potenti organ harm advers effect human health environ quot risk quot combin magnitud consequ hazard occur likelihood consequ occur step 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 gmo import discount potenti advers effect basi occur potenti advers effect gmo vari case case includ diseas human includ allergen toxic effect diseas anim plant includ toxic allergen effect effect dynam popul speci receiv environ genet divers popul 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 effect biogeochemistri biogeochem cycl carbon nitrogen recycl soil decomposit organ materi exampl potenti advers effect annex iiia iiib direct ec identifi hazard harm characterist advers effect relat gene gene interest deliber introduc gmo protein express gene addit advers effect pleiotrop effect gener result method creat transgen locat construct genom gmo transgen insert transgen transfer recipi transgen transfer gmo potenti interact transgen account potenti epigenet regulatori effect import defin hazard accur case hazard head set hazard identifi purpos era specif case potenti advers effect human health allergen toxigen identifi consid separ era hazard present gmo present regard inher properti hazard give rise likelihood step neg consequ consequ turn order magnitud step final individu hazard summaris gmo stage era hazard introduc result genet modif advers effect step scientif basi step era stage critic identifi potenti hazard specif level scientif uncertainti account stage advers effect occur directli indirectli mechan includ spread gmo environ distribut pathwai show potenti pathwai distribut gmo potenti hazard environ human toxic inhal toxic microorgan toxic protein potenti gmo spread environ depend biolog fit gmo design perform environ interest express trait lead increas competit natur environ qualit quantit chang composit ingredi gmo resist natur select pressur diseas abiot stress heat cold salt product anti microbi substanc microorgan condit deliber releas place market area releas scale number gmo releas likelihood deliber releas place market unintent releas environ gmo process pathwai dispers viabl materi seed spore wind water anim environment consider site specif region specif site site region region assess classifi data habitat area reflect aspect receiv environ relev gmo botan data occurr crossabl wild rel gmo plant agricultur natur habitat europ import assess length time individu gmo specif number gmo speci gener surviv readi dissemin establish varieti habitat consider reproduct surviv dormant form includ plant viabil pollen seed veget structur microorgan viabil spore surviv form potenti microorgan enter viabl cultiv state spread potenti vari consider depend speci genet modif receiv environ plant cultiv desert fish cultiv sea transfer insert genet materi organ organ genet modifi hazard result advers effect gene transfer speci speci vertic horizont gene transfer speed extent gene transfer speci sexual compat case higher organ depend reproduct properti gmo includ modifi sequenc condit releas environment consider climat wind differ reproduct biologi agricultur practic avail potenti cross partner transport pollin vector insect bird anim gener avail host parasit occurr specif advers effect gene transfer link number gmo releas larg field transgen plant complet potenti gene transfer small field proport basi qualit quantit inform exist potenti cross partner recipi plant relev distanc import higher plant anim distinct made gene transfer close relat distantli relat unrel speci case microorgan horizont gene transfer plai import role genet materi easi transfer close relat organ plasmid phage potenti rapid growth rate microorgan enabl gene transfer high level compar higher organ transfer transgen lead mix popul gmo gene plant combin time give rise complex pattern long term advers effect complex transgen materi transfer popul gene stack case method genet modif chang potenti gene transfer case integr plasmid viral vector method genet modif decreas potenti gene transfer chloroplast transform gene transfer result persist introduc genet materi natur popul gmo potenti gene transfer necessarili intrins risk chang capac surviv establish advers effect depend genet materi insert speci receiv environ includ potenti recipi phenotyp genet instabl extent genet stabil lead phenotyp stabil result hazard consid instabl genet modif case result revers wild type phenotyp case consid transgen plant line transgen subsequ segreg process result transgen divid progeni plant transgen phenotyp attenu mutant due instabl construct mutat revert virul duplic transgen lead gene silenc copi number high insert transpos element result phenotyp due inactiv transgen insert mobil genet element level transgen express import low express toxic substanc genet instabl regulatori element result higher transgen express phenotyp instabl result interact environ cultiv effect environment agronom factor express transgen consid era transgen express limit compart gmo plant tissu instabl regul result express transgen entir organ context regulatori signal promot plai import role consid express transgen time life cycl organ specif environment condit consid specif infertil transgen introduc gmo make infertil prevent transfer spread transgen instabl infertil transgen result reactiv fertil plant allow spread transgen advers affect stabil transgen primari gmo progeni import long term effect interact organ exchang genet materi pollen interact organ includ gmo carefulli assess take account complex multitroph interact directli hazard interact advers effect includ exposur human farmer consum exposur anim competit natur resourc soil area water light displac natur popul organ deliveri toxic substanc growth pattern gener biolog fit enhanc genet modif gmo invad environ replac exist speci occurr specif advers effect proportion link scale releas manag includ applic agricultur practic relev manag procedur unavoid consequ deliber releas gmo assess basi exist procedur farm manag relat sow plant grow harvest transport crop plant small larg field time crop rotat cultiv plant speci year fourth year diseas pest control type dose insecticid plant antibiot anim altern measur resist manag type dose herbicid herbicid toler plant chang biolog control bt protein impact virus isol land agricultur aquat agricultur system isol distanc plant cultiv qualiti isol fish farm agricultur practic farm gmo transgen farm includ organ farm manag agricultur system isol distanc natur habitat gmo plant area step evalu potenti consequ advers effect occur magnitud consequ potenti advers effect evalu likelihood potenti harm characterist occur chapter step evalu magnitud consequ import part risk assess magnitud extent consequ potenti hazard gmo deliber releas market realis magnitud relat baselin influenc genet construct advers effect identifi number gmo releas scale environ gmo releas condit releas includ control measur combin advers effect identifi consequ organ popul speci ecosystem expos gmo evalu requir detail knowledg environ gmo releas site region method releas consequ rang quot neglig quot insignific limit quot high quot signific advers effect possibl lead long term perman advers effect quantit term magnitud express quot high quot quot moder quot quot low quot quot neglig quot case identifi advers effect environ case risk advers effect assess quot neglig quot insignific suggest illustr qualit exampl broad sens intend definit exclus give indic consider account weigh consequ quot high level consequ quot signific number speci organ includ endang benefici speci short long term includ reduct complet erad speci lead neg effect function ecosystem connect ecosystem readili revers recoveri ecosystem place slow quot moder consequ quot signific popul densiti organ chang result total erad speci signific effect endang benefici speci transient substanti popul includ revers long term effect provid neg effect function ecosystem quot low level consequ quot signific popul densiti organ result total erad popul speci organ neg effect function ecosystem organ affect endang benefici speci short long term quot neglig consequ quot signific caus popul environ ecosystem exampl reflect potenti advers effect gmo popul case effect individu organ singl hazard advers effect fact magnitud individu advers effect advers effect singl hazard human health agricultur natur habitat vari potenti consequ summaris cover ecolog entiti affect speci popul trophic level ecosystem includ potenti effect level uncertainti step evalu likelihood occurr identifi potenti advers effect major factor evalu likelihood probabl advers effect occur characterist environ gmo intend releas manner releas magnitud consequ hazard chapter step evalu likelihood advers effect occur import part assess risk step estim advers effect occur case likelihood frequenc address step evalu potenti consequ advers effect occur hazard number gmo receiv environ condit releas import defin likelihood climat geograph soil demograph condit type flora fauna potenti receiv environ import consider capabl surviv assess proport gmo surviv intend risk manag measur propos deliber releas place market gene transfer probabl number event extent transfer occur consid gmo pathogen toxic characterist proport target organ environ affect assess likelihood occurr effect depend specif risk manag measur prevent risk occur pollen dispers imposs due destruct infloresc advers effect identifi rel likelihood consequ assess quantit express term quot high quot quot moder quot quot low quot quot neglig quot exampl reflect potenti advers effect gmo popul case effect individu organ singl hazard advers effect likelihood individu advers effect advers effect singl hazard human health agricultur natur habitat vari likelihood summaris cover ecolog entiti affect speci popul trophic level ecosystem includ measur potenti effect level uncertainti step 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 basi conclus reach step estim risk advers effect made hazard identifi step quantit evalu evalu hazard magnitud consequ quot high quot quot moder quot quot low quot quot neglig quot likelihood advers effect quot high quot quot moder quot quot low quot quot neglig quot hazard advers effect magnitud likelihood individu advers effect gmo consid case case basi gener attempt quantifi made carefulli case high magnitud consequ advers effect combin neglig likelihood occur result rang high risk neglig risk result depend circumst case weight factor notifi set justifi record era uncertainti identifi risk possibl includ document relat assumpt extrapol made level era scientif assess viewpoint uncertainti limit mitig measur conclus deriv data era base quantifi outcom result era qualit era result rel compar gm refer instanc qualit step applic manag strategi risk deliber releas market gmo era identifi risk requir measur manag risk manag strategi defin appli risk manag consider view prevent modifi releas prefer risk neglig genet element advers effect undefin avoid gene construct process genet element prefer remov gmo stage prior deliber releas place market account step risk manag control identifi risk cover uncertainti safeguard measur proportion level risk level uncertainti relev data stage risk manag adapt line data reduc risk manag measur achiev end risk gene toxic insect insert crop plant transfer relat plant speci suitabl control measur includ spatial tempor isol relat speci chang releas site area exposur specif risk plant speci manag strategi includ isol measur relev stage handl gmo includ wide rang measur includ mean isol reproduct physic biolog barrier clean machin contain contact gmo detail risk manag procedur depend gmo type scale deliber releas place market type gmo genet modifi microorgan higher annual plant higher long life plant anim gmo singl multipl modif kind gmo gener type habitat biogeochem statu climat avail inter interspecif cross partner centr origin connect habitat type agricultur habitat agricultur forestri aquat cultur rural area size site number gmo type natur habitat statu preserv area clear statement implic risk manag term adjust experi condit place market consequ reduct risk achiev step determin risk gmo evalu risk gmo made take account risk manag strategi propos basi step step final evalu made risk includ magnitud likelihood advers effect gmo base combin risk individu advers effect includ cumul effect gmo final evalu express form summari risk deliber releas place market includ uncertainti conclus potenti environment impact releas place market gmo basi era carri accord gener principl methodolog outlin section inform point list section annex ii direct ec includ notif view assist draw conclus potenti environment impact releas place market gmo futur develop plant area give guidanc inform includ notif review adapt review adapt era era view static regularli review updat chang account relev data accord articl direct ec review effect effici accuraci era risk manag take account data research deliber releas monitor data depend level uncertainti determin era review era risk manag adapt upgrad review adapt era guidanc futur develop genet modif make adapt technic progress annex ii guidanc note differenti inform requir type gmo singl cell organ fish insect gmo develop vaccin suffici experi notif releas gmo commun annex iii fourth paragraph review adapt era guidanc account adapt technic progress develop guidanc base experi suffici releas gmo ecosystem accord criteria set annex articl direct experi scientif evid relat safeti human health environ connect place market gmo articl text ital directli annex ii direct ec