council direct ec octob amend direct eec contain genet modifi micro organ council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur laid articl treati mean treati action commun relat environ base principl prevent action object preserv protect improv environ protect human health contain genet modifi micro organ gmm classifi relat risk present human health environ classif line intern practic base assess risk order ensur high level protect contain protect measur appli contain correspond classif contain case uncertainti contain protect measur higher classif appli stringent measur justifi data measur adopt control dispos materi contain gmm gmm dispos provis specif contain measur limit contact gener popul environ fall scope present direct commun legisl council direct eec april deliber releas environ genet modifi organ appli exempt pursuant direct entail exempt pursuant commun legisl appli direct eec activ involv gmm principl good microbiolog practic good occup safeti hygien appli accord relev commun legisl contain protect measur appli contain review period peopl emploi contain consult accord requir relev commun legisl council direct eec novemb protect worker risk relat exposur biolog agent work seventh individu direct mean articl direct eec weak identifi direct eec administr procedur notif requir link risk contain direct eec permit suffici adapt technic progress technic part direct adapt technic progress implement direct eec benefit addit list gmm safe human health environ gmm meet criteria order establish safeti account pace biotechnolog advanc natur criteria develop limit scope list council defin revis criteria consider experi knowledg risk contain gmm direct eec amend adopt direct articl direct eec amend articl replac articl purpos direct quot micro organ quot microbiolog entiti cellular cellular capabl replic transfer genet materi includ virus viroid anim plant cell cultur quot genet modifi micro organ quot gmm micro organ genet materi alter occur natur mate natur recombin term definit genet modif occur techniqu list annex part ii techniqu list annex part consid result genet modif quot contain quot activ micro organ genet modifi gmm cultur store transport destroi dispos specif contain measur limit contact gener popul environ quot accid quot incid involv signific unintend releas gmm contain present delai hazard human health environ quot user quot natur legal person respons contain gmm quot notif quot present requisit inform compet author member state articl prejudic articl direct appli genet modif obtain techniqu method list annex ii part contain involv type gmm meet criteria list annex ii part establish safeti human health environ type gmm list annex ii part articl articl articl appli transport gmm road rail inland waterwai sea air direct appli storag cultur transport destruct dispos gmm market accord council direct eec april deliber releas environ genet modifi organ pursuant commun legisl specif environment risk assess similar laid direct provid contain accord condit consent place market oj direct amend commiss direct ec oj articl member state ensur measur avoid advers effect human health environ aris contain gmm end user carri assess contain risk human health environ contain incur minimum element assess procedur set annex iii section assess refer paragraph result final classif contain class appli procedur set annex iii result assign contain level accord articl gt tabl gt doubt class propos contain stringent protect measur appli suffici evid agreement compet author justifi applic stringent measur assess refer paragraph account question dispos wast effluent safeti measur implement order protect human health environ record assess refer paragraph user made form compet author part notif pursuant articl request articl user appli extent paragraph annex iv measur appli gener principl contain protect measur set annex iv class contain workplac environment exposur gmm lowest practic level high level safeti ensur assess refer articl contain protect measur appli review period forthwith contain measur appli longer adequ class assign contain longer correct reason suspect assess longer judg light scientif technic knowledg articl premis time contain user requir submit compet author commenc notif inform list annex part articl notif refer articl subsequ class contain proce notif user gmm class contain requir record assess refer articl made compet author request articl subsequ class contain carri premis notifi accord articl notif inform list annex part submit premis subject previou notif carri class higher class contain consent requir satisfi class contain proce immedi notif applic request decis formal authoris compet author decis made maximum dai notif premis subject previou notif carri class higher class contain class contain absenc indic contrari compet author proce dai submiss notif refer paragraph earlier agreement compet author articl subsequ class class contain carri premis notifi accord articl notif inform list annex part submit class higher class contain proce prior consent compet author commun decis write latest dai submiss notif case premis subject previou notif carri class higher class contain consent requir satisfi higher class contain intend proce latest dai submiss notif case articl member state design author author compet implement measur adopt applic direct receiv acknowledg notif refer articl compet author examin conform notif requir direct accuraci complet inform correct assess refer articl class contain suitabl contain protect measur wast manag emerg respons measur compet author user provid inform modifi condit propos contain amend class assign contain case compet author requir contain propos begin progress suspend termin compet author approv basi inform obtain modifi condit contain limit time contain permit subject specif condit purpos calcul period refer articl period time compet author await inform request notifi accord paragraph carri public inquiri consult accord articl account articl user awar relev inform modifi contain signific consequ risk pose compet author inform notif pursuant articl modifi inform subsequ compet author signific consequ risk pose contain compet author requir user modifi condit suspend termin contain articl member state consid provid public consult aspect propos contain prejudic articl articl compet author ensur contain commenc emerg plan drawn contain failur contain measur lead danger delai human premis environ emerg plan drawn commun legisl inform emerg plan includ relev safeti measur appli suppli manner request bodi author liabl affect accid inform updat interv made publicli member state concern time make member state concern basi consult framework bilater relat inform dissemin nation articl member state measur ensur event accid user requir inform immedi compet author articl provid inform circumst accid ident quantiti gmm concern inform assess effect accid health gener popul environ measur inform pursuant paragraph member state requir ensur measur immedi alert member state affect accid collect inform full analysi accid make recommend avoid similar accid futur limit effect thereof articl member state requir consult member state affect event accid propos implement emerg plan inform commiss accid scope direct give detail circumst accid ident quantiti gmm concern respons measur effect analysi accid includ recommend limit effect avoid similar accid futur commiss consult member state establish procedur exchang inform pursuant paragraph set dispos member state regist accid scope direct includ analysi accid experi gain measur avoid similar accid futur articl replac articl member state send commiss end year summari report class class contain notifi year pursuant articl includ descript purpos risk contain year member state send commiss summari report experi direct time june year commiss publish summari base report refer paragraph time june commiss publish gener statist inform implement direct relat matter long inform harm competit posit user articl disclosur affect item mention articl council direct eec june freedom access inform environ notifi inform notif submit pursuant direct treat confidenti verifi justif case compet author decid consult notifi inform confidenti inform notifi decis case inform submit articl confidenti gener characterist gmm address notifi locat class contain measur contain evalu forese effect harm effect human health environ commiss compet author divulg parti inform decid confidenti paragraph notifi provid pursuant direct protect intellectu properti right relat data receiv reason notifi withdraw notif compet author respect confidenti inform suppli oj articl amend adapt annex ii part annex iii technic progress adapt annex ii part decid accord procedur laid articl articl insert articl decemb annex ii part list criteria inclus type gmm annex ii part adopt council act qualifi major propos commiss amend annex ii part adopt council act qualifi major propos commiss annex replac annex shown annex hereto articl member state bring forc law regul administr provis compli direct month date entri forc forthwith inform commiss thereof member state adopt provis refer direct accompani refer occas offici public method make refer laid member state member state commun commiss text main provis nation law adopt field cover direct articl direct enter forc dai public offici journal european commun articl direct address member state luxembourg octob council presid schüssel oj oj oj opinion european parliament march oj council common posit decemb oj decis european parliament june oj oj direct amend commiss direct ec oj oj direct amend commiss direct ec oj oj direct amend commiss direct ec oj annex annex 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 micro organ herit materi prepar micro organ includ micro inject macro inject micro encapsul cell fusion hybridis techniqu live cell combin herit genet materi form fusion cell mean method occur natur part techniqu refer articl ii consid result genet modif condit involv recombin nucleic acid molecul gmm made techniqu method techniqu method exclud annex ii part vitro fertilis natur process conjug transduct transform polyploidi induct annex ii part techniqu method genet modif yield micro organ exclud direct condit involv recombin nucleic acid molecul gmm produc techniqu method list mutagenesi cell fusion includ protoplast fusion prokaryot speci exchang genet materi physiolog process cell fusion includ protoplast fusion cell eukaryot speci includ product hybridoma plant cell fusion clone consist remov nucleic acid sequenc cell organ reinsert part nucleic acid synthet equival prior enzym mechan step cell speci cell phylogenet close relat speci exchang genet materi natur physiolog process result micro organ diseas human anim plant clone includ recombin vector extend histori safe micro organ part criteria establish safeti gmm human health environ complet accord procedur articl part type gmm meet criteria list part complet accord procedur articl annex iii principl assess refer articl annex describ gener term element consid procedur perform assess refer articl supplement section guidanc note develop commiss accord procedur set articl guidanc note complet june element assess consid potenti harm effect diseas human includ allergen toxic effect diseas anim plant deleteri effect due imposs treat diseas provid effect prophylaxi deleteri effect due establish dissemin environ deleteri effect due natur transfer insert genet materi organ assess refer articl base identif potenti harm effect recipi micro organ ii genet materi insert origin donor organ iii vector iv donor micro organ long donor micro organ oper result gmm characterist activ sever potenti harm effect likelihood potenti harm effect realis procedur stage assess process identifi harm properti recipi donor micro organ harm properti vector insert materi includ alter recipi exist properti gener gmm show characterist consid inclus class defin articl recipi parent micro organ diseas human anim plant appli anim plant environ expos ii natur vector insert endow gmm phenotyp diseas human anim plant deleteri effect environ iii gmm diseas human anim plant deleteri effect environ order obtain inform implement process user firstli account relev commun legisl council direct eec intern nation classif scheme nih revis due scientif knowledg technic progress consid scheme concern natur micro organ base abil micro organ diseas human anim plant sever transmiss diseas caus direct eec classifi micro organ biolog agent class risk basi potenti effect healthi human adult class risk guidanc categoris contain activ class risk refer articl user consider classif scheme refer plant anim pathogen establish nation basi abovement classif scheme give provision indic risk class activ set contain control measur hazard identif process carri accord paragraph lead identif level risk gmm select contain protect measur made basi level risk gmm consider characterist environ expos environ expos gmm biota advers affect micro organ contain activ ii characterist activ scale natur iii standard oper inocul anim gmm equip gener aerosol consider item iii activ increas reduc leav unalt level risk gmm identifi paragraph analysi carri final lead assign activ class articl final classif contain confirm review complet assess refer articl appli anim plant environ expos oj direct amend commiss direct ec oj annex iv contain protect measur gener principl tabl present normal minimum requir measur level contain contain achiev good work practic train contain equip special instal design activ involv gmm principl good microbiolog practic principl good occup safeti hygien appli workplac environment exposur gmm lowest practic level ii exercis engin control measur sourc supplement person protect cloth equip iii test adequ maintain control measur equip iv test presenc viabl process organ primari physic contain provid train personnel vi establish biolog safeti committe subcommitte requir vii formul implement local code practic safeti personnel requir viii displai biohazard sign ix provid wash decontamin facil personnel adequ record xi prohibit eat drink smoke appli cosmet store food human consumpt work area xii prohibit mouth pipet xiii provid written standard oper procedur ensur safeti xiv effect disinfect disinfect procedur case spillag gmm xv provid safe storag contamin laboratori equip materi titl tabl indic tabl present minimum requir laboratori activ tabl present addit modif tabl glasshous growth room activ involv gmm tabl present addit modif tabl activ anim involv gmm tabl ii present minimum requir activ laboratori activ case appli combin measur tabl tabl ii level case user agreement compet author appli specif contain level combin specif level tabl quot option quot mean user appli measur case case basi subject assess refer articl member state implement annex incorpor addit gener principl paragraph tabl sake clariti requir gt tabl gt tabl contain protect measur glasshous growth room term quot glasshous quot quot growth room quot refer structur wall roof floor design princip grow plant control protect environ provis tabl appli addit modif gt tabl gt gt tabl gt gt tabl gt annex part inform requir notif refer articl user includ respons supervis safeti inform train qualif person respons supervis safeti detail biolog committe subcommitte address gener descript premis descript natur work undertaken class contain class contain summari assess refer articl inform wast manag part inform requir notif refer articl date submiss notif refer articl person respons supervis safeti inform train qualif recipi donor parent micro organ applic host vector system sourc intend function genet materi involv modif ident characterist gmm purpos contain includ expect result approxim cultur volum descript contain protect measur appli includ inform wast manag includ wast gener treatment final form destin summari assess refer articl inform compet author evalu emerg respons plan requir articl part inform requir notif refer articl date submiss notif refer articl person respons supervis safeti inform train qualif recipi parent micro organ host vector system applic sourc intend function genet materi involv modif ident characterist gmm cultur volum descript contain protect measur appli includ inform wast manag includ type form wast gener treatment final form destin purpos contain includ expect result descript part instal inform accid prevent emerg respons plan specif hazard aris locat instal prevent measur appli safeti equip alarm system contain method procedur plan verifi continu effect contain measur descript inform provid worker inform compet author evalu emerg respons plan requir articl copi assess refer articl