commiss decis januari amend decis eec guidelin classif refer articl council direct eec contain genet modifi micro organ text eea relev ec commiss european commun regard treati establish european commun regard council direct eec april contain genet modifi micro organ amend direct ec articl thereof purpos direct eec genet modifi micro organ classifi group criteria annex ii provid guidelin drawn classif consequ commiss establish decis eec guidelin interpret annex ii direct eec result experi consid adapt technic progress criteria classif set annex ii revis guidelin classif provis decis receiv favour opinion committe member state repres accord procedur laid articl direct eec adopt decis articl annex decis eec replac annex hereto articl decis address member state brussel januari commiss ritt bjerregaard member commiss oj oj oj annex guidelin classif genet modifi micro organ group articl direct eec classif gmm group guidelin interpret criteria establish annex ii direct eec develop compet author detail guidelin aim specif case criteria iii refer immunocompet human healthi anim plant criterion annex ii guidelin decid recipi parent micro organ diseas anim plant consider environ expos recipi parent micro organ virul strain acknowledg pathogen speci consid diseas satisfi criterion annex ii provid virul strain establish record safeti laboratori industri advers effect human anim plant health ii strain stabli defici genet materi determin virul stabl mutat suffici reduc virul essenti remov virul determin pathogen attent paid toxin gene plasmid phageborn virul determin harm adventiti agent occas case case evalu need criterion ii annex ii guidelin vector insert gene express activ protein transcript virul determin toxin level form endow genet modifi micro organ phenotyp diseas human anim plant case vector insert sequenc involv express harm trait micro organ endow gmm phenotyp diseas human anim plant advers effect environ vector insert transmiss poorli mobiliz case type oper special consider vector transmiss function transpos sequenc poorli mobiliz decid vector insert endow genet modifi micro organ phenotyp diseas human anim plant advers effect environ import ensur vector insert character limit size genet sequenc requir perform intend function criterion iii annex ii guidelin decid gentic modifi micro organ advers effect environ diseas anim plant consider environ expos gmm case type oper addit criterion iii consider genet modifi micro organ transfer resist marker micro organ transfer compromis diseas treatment genet modifi micro organ safe industri set recipi parent micro organ characterist limit surviv gene transfer gmm includ group advers effect environ meet condit annex ii construct singl prokaryot recipi includ indigen plasmid transposon virus singl eukaryot recipi includ chloroplast mitochondria plasmid exclud virus consist genet sequenc speci exchang sequenc physiolog process decid gmm includ group consid exclud direct provis annex take account clone mean remov nucleic acid cell organ reinsert part nucleic acid enzym chemic mechan step cell type cell line cell phylogenet close relat speci natur exchang genet materi donor speci