commiss regul ec april detail rule implement regul ec european parliament council applic authoris genet modifi food feed notif exist product adventiti technic unavoid presenc genet modifi materi benefit favour risk evalu text eea relev commiss european commun regard treati establish european commun regard regul ec european parliament council septemb genet modifi food feed articl thereof consult european food safeti author accord articl regul ec regul ec lai commun procedur authoris supervis genet modifi food feed label food feed provid detail rule applic authoris submit accord regul ec addit regul ec european food safeti author author publish detail guidanc assist applic prepar present applic notabl inform data provid order demonstr product compli criteria refer articl regul order ensur smooth transit regim provid regul ec transit measur laid regul request notif product fall scope commun legisl subject implement rule provid detail rule prepar present notif exist product submit commiss regul ec product market commun april rule facilit task oper prepar applic authoris prepar notif exist product author evalu applic verifi notif scope regul ec includ food consist produc genet modifi organ gmo genet modifi plant micro organ interest consist commun legisl scope present regul cover exist food consist produc genet modifi plant micro organ scope regul ec cover feed includ feed addit defin council direct eec novemb addit feed stuff consist produc gmo genet modifi plant micro organ scope present regul cover exist feed includ feed addit consist produc genet modifi plant micro organ scope regul ec cover process aid includ enzym process aid scope present regul similarli cover exist process aid regul ec detail rule adopt implement transit measur adventiti technic unavoid presenc genet modifi materi benefit favour risk evalu interest consist commun legisl rule clarifi genet modifi materi cover transit measur threshold appli regul appli matter urgenc regul ec appli april measur provid regul accord opinion stand committe food chain anim health adopt regul chapter applic authoris articl chapter detail rule applic authoris submit accord articl regul ec includ applic submit commun legisl transform supplement accord articl regul section requir applic authoris genet modifi food feed articl prejudic articl articl regul ec take account guidanc european food safeti author author provid articl regul applic authoris submit accord articl regul ec applic compli requir paragraph articl articl regul suppli inform requir articl articl regul ec applic identifi product cover accord articl regul applic limit food feed verifi justif explain authoris cover accord articl regul ec applic state part applic consid confidenti verifi justif accord articl regul ec confidenti part submit separ document applic suppli inform requir articl articl regul ec inform includ applic notifi biosafeti clear hous cartagena protocol biosafeti convent biolog divers cartagena protocol approv council decis ec applic notifi includ inform compli annex ii cartagena protocol notifi biosafeti clear hous commiss provid articl regul ec separ identifi document paragraph appli applic food feed produc genet modifi organ gmo ingredi produc gmo articl applic includ monitor plan refer articl articl regul ec take account council decis ec suppli inform requir articl articl regul ec propos label compli requir annex iv direct ec european parliament council suppli inform requir articl articl regul ec propos uniqu identifi gmo question develop accord commiss regul ec propos label offici commun languag propos specif label need accord articl articl regul ec descript method detect sampl event specif identif transform event provid articl articl regul ec accord annex regul propos post market monitor food human consumpt feed anim consumpt provid articl articl regul ec characterist product concern verifi justif effect post market monitor point paragraph appli applic food feed produc gmo ingredi produc gmo articl sampl food feed control sampl submit accord articl articl regul ec accord requir set annex ii regul applic accompani inform place refer materi develop accord annex ii found summari provid accord articl articl regul ec present easili comprehens legibl form part consid confidenti section transform request notif applic accord regul ec articl request submit articl regul ec european parliament council transform applic regul ec accord articl regul nation compet author member state request submit delai applic submit complet dossier accord articl regul ec nation compet author acknowledg receipt inform suppli applic accord paragraph dai date receipt acknowledg state date receipt inform inform author delai make request inform suppli applic accord paragraph author applic make author initi assess report provid articl regul ec comment object made member state commiss articl regul author inform member state commiss delai request articl regul ec transform applic regul ec make applic supplementari inform suppli applic make summari dossier refer articl regul ec public date receipt applic purpos articl regul ec date receipt author inform refer point paragraph articl transform applic process applic articl regul ec articl notif product includ feed submit articl direct ec transform applic regul ec accord articl regul nation compet author mean direct ec member state notif submit delai notifi submit complet dossier accord articl regul ec nation compet author acknowledg receipt inform suppli notifi accord paragraph dai date receipt acknowledg state date receipt inform inform author delai make notif inform suppli notifi accord paragraph author applic make author assess report provid articl direct ec author inform member state commiss delai notif articl direct ec transform applic regul ec make applic supplementari inform suppli notifi make summari dossier refer articl regul ec public date receipt applic purpos articl regul ec date receipt author inform refer point paragraph articl transform applic process applic articl regul ec articl request submit articl council direct eec product produc gmo transform applic regul ec accord articl regul commiss applic delai submit complet dossier accord articl regul ec applic send complet dossier member state commiss commiss acknowledg receipt inform suppli applic accord paragraph dai date receipt acknowledg state date receipt inform inform author delai make request inform suppli applic accord paragraph author applic make author dossier provid articl direct eec author make supplementari inform suppli applic member state commiss summari dossier refer articl regul ec public date receipt applic purpos articl regul ec date receipt author inform refer point paragraph articl transform applic process applic articl regul ec section supplement request direct eec applic regul ec articl request submit articl direct eec product refer articl regul ec supplement applic regul ec accord articl regul member state act rapporteur applic delai submit separ applic authoris accord articl regul ec applic process applic articl regul ec chapter ii notif exist product articl chapter requir prepar present notif exist product submit commiss accord articl regul ec appli exist product cover scope regul market commun prior april section gener requir notif product market april articl notif submit accord articl regul ec identifi product cover notif take account articl regul ec includ relev inform studi includ independ peer review studi demonstr product compli requir provid articl regul ec part notif consid confidenti verifi justif part submit separ document includ method detect sampl identif transform event accord annex regul accord articl regul ec provid sampl food feed control sampl accord annex regul ii inform place refer materi develop accord annex ii regul found notif refer paragraph submit commiss octob section addit requir notif product market april articl addit requir articl notif gmo market accord part council direct eec part direct ec includ copi relev consent grant direct date public offici journal european union decis grant consent direct eec direct ec consid date product market notifi verifi proof market date articl addit requir articl notif food produc gmo market accord articl regul ec includ copi origin notif letter commiss date letter commiss forward origin notif member state consid date product market notifi verifi proof market date articl addit requir articl notif genet modifi food market accord articl regul ec includ copi authoris food date authoris product effect regul ec consid date market notifi verifi proof product market date articl addit requir articl notif feed produc gmo market accord articl direct eec includ copi authoris commun level applic authoris grant member state date authoris product effect accord direct eec consid date market notifi verifi proof product market date articl addit requir articl notif feed consist produc gmo authoris accord direct eec includ identif feed addit cover number ec number applic laid articl direct eec copi authoris date authoris product effect direct eec consid date market notifi verifi proof product market date articl addit requir articl notif feed produc gmo lawfulli market commun cover articl gmo notifi authoris anim feed part direct ec refer notif evalu submit articl direct ec includ declar product market april articl addit requir articl notif food feed produc gmo lawfulli market commun cover articl includ declar product market april chapter iii transit measur adventiti technic unavoid presenc genet modifi materi benefit favour risk evalu articl purpos implement articl regul ec commiss april publish list genet modifi materi benefit favour opinion commun scientif committe author date applic authoris reject accord relev commun legisl list distinguish materi respect commiss inform interest parti detect method publicli indic detect method made includ materi respect commiss inform detect method publicli interest parti time inform commiss detect method materi refer point subparagraph publicli indic detect method list refer paragraph maintain commiss amend list result grant authoris reject applic authoris materi includ list accord relev commun legisl notif commiss accord articl regul ec materi includ list lawfulli market commun april adopt commiss measur accord articl regul ec inform receiv commiss detect method respect materi includ list publicli inform amend brought list compil annex list articl threshold provid articl regul ec appli genet modifi materi includ part list refer articl present regul lower threshold establish accord articl regul ec list threshold provid articl regul ec appli food ingredi consid individu food consist singl ingredi feed feed compos chapter iv final provis articl regul enter forc dai public offici journal european union appli april regul bind entireti directli applic member state brussel april commiss david byrn member commiss oj oj direct amend regul ec oj oj oj oj oj oj oj oj annex method valid introduct purpos implement articl regul ec annex technic provis type inform detect method provid applic need verifi precondit fit method includ inform method method test carri applic guidanc document refer annex produc commun refer laboratori crl made crl method accept criteria method perform requir compil european network gmo laboratori engl document entitl quot definit minimum perform requir analyt method gmo test quot made crl quot method accept criteria quot criteria fulfil prior initi method valid crl quot method perform requir quot defin minimum perform criteria method demonstr complet valid studi carri crl internation accept technic provis order certifi method valid fit purpos enforc regul ec crl establish regul ec assist engl evalu provid inform complet fit purpos method accept criteria recommend engl account inform provid method consid adequ fulfil method accept criteria crl initi valid process method valid process carri crl internation accept technic provis crl engl provid inform oper procedur valid process make document crl assist engl evalu result obtain valid studi fit purpos method perform requir account inform method method refer methodolog step need analys relev materi accord articl regul ec materi includ method dna extract subsequ quantif polymeras chain reaction pcr system case process extract pcr techniqu equival constitut method applic provid inform method document refer engl recognis modular method principl applic allow refer exist method modul instanc dna extract method matrix case applic provid experiment data hous valid method modul successfulli appli context applic authoris applic demonstr method fulfil requir method event specif function gmo gm base product consid function appli event authoris method appli unequivoc detect identif quantif demonstr select target transgen authoris event convent counterpart case gm plant test includ close relat event relev case limit detect test specif principl appli product consist gmo plant method applic sampl food feed control sampl refer materi refer articl regul ec method develop take document consider gener requir definit draft european standard pren iso nucleic acid extract pren iso quantit nucleic acid base method draft european standard pren iso protein base method adopt european standard en iso qualit nucleic acid base method draft european standard pren iso purpos implement articl regul ec applic provid case applic authoris cover gmo product consist gmo product produc gmo event specif quantit detect method gm materi addit case applic authoris cover product produc gmo genet modifi materi detect event specif quantit detect method food feed produc gmo applic provid complet detail descript method point address scientif basi overview principl method work dna molecular biologi base real time pcr inform provid recommend provid refer relev scientif public scope method indic matrix process food raw materi type sampl percentag rang method appli oper characterist method requir equip applic method mention regard analysi se sampl prepar inform specif aspect crucial applic method mention protocol applic provid complet optimis protocol method protocol present detail requir transfer appli method independ laboratori recommend protocol templat obtain crl protocol includ detail analyt test work condit instruct rule materi need includ estim amount storag handl instruct equip need includ main equip pcr system centrifug small item micropipett reaction tube indic size step oper protocol instruct data record programm set paramet includ predict model alik need interpret result make infer full detail instruct correct applic model provid inform method test carri applic applic provid relev data method optimis test carri data result present perform paramet recommend engl refer summari test carri main result data includ outlier provid crl engl continu provid technic provis format data inform provid demonstr robust method inter laboratori transfer mean method test laboratori independ laboratori develop method import pre condit success valid method inform requir method develop method optimis primer pair test case pcr base test justif propos primer pair select stabil test experiment result test method varieti provid specif applic submit full sequenc insert base pair host flank sequenc need establish event specif detect method crl enter data molecular databas run homolog search crl posit assess specif propos method test report valu obtain perform indic inform test provid particip laboratori time analysi outlin experiment design includ detail number run sampl replic descript laboratori sampl size qualiti date sampl posit neg control refer materi plasmid alik descript approach analys test result outlier point observ test refer relev literatur technic provis test sampl food feed control sampl view implement articl regul ec applic inform section annex provid sampl food feed control sampl type amount crl specif applic authoris annex ii refer materi refer materi refer articl regul ec produc accord internation accept technic provis iso guid iso guid gener requir compet refer materi produc refer materi prefer certifi case certif accord iso guid verif assign method properli valid iso iec uncertainti estim gum iso guid express uncertainti measur gum major characterist internation accept technic provis terminolog refer materi rm materi substanc properti valu suffici homogen establish calibr apparatu assess measur method assign valu materi certifi refer materi crm refer materi accompani certif properti valu certifi procedur establish traceabl accur realis unit properti valu express certifi accompani uncertainti state level confid gm rm contain gm rm contain bottl vial ampoul tight state amount materi sampl homogen stabil commut gm rm assur packag purpos label good aspect qualiti homogen test bottl homogen examin bottl heterogen account estim rm uncertainti requir appli statist signific bottl variat present case method variat actual calcul bottl variat whichev larger includ uncertainti stabil test stabil posit demonstr statist extrapol gm rm shelf life state uncertainti uncertainti relat demonstr part estim rm uncertainti assign valu valid limit time subject stabil monitor batch characteris method verif certif appli metrolog valid condit properli technic valid precis accuraci compat target uncertainti set measur traceabl state refer accompani uncertainti statement particip laboratori requir compet execut task achiev traceabl requir state refer estim measur uncertainti place suffici qualiti assur system final storag avoid posterior degrad sampl store condit design final storag gm rm measur start transport door door keep time storag condit demonstr influenc assign valu establish certif crm certif complement certif report establish inform relev need user certif report made gm crm distribut certifi valu traceabl state refer accompani expand uncertainti statement valid entir shelf life gm crm