commiss recommend juli scientif aspect present inform support applic place market food food ingredi prepar initi assess report regul ec european parliament council text eea relev ec commiss european commun regard treati establish european commun regard regul ec european parliament council januari food food ingredi articl thereof order protect public health food food ingredi subject singl safeti assess commun procedur market commun recommend scientif aspect inform support applic place market food food ingredi facilit task econom oper prepar applic recommend present inform prepar initi assess report compet food assess bodi member state facilit evalu applic scientif committe food made recommend inform support applic present inform prepar initi assess report applic experi assess food food ingredi present limit recommend area constant review account scientif inform work relev intern organ member state consult recommend framework stand committe foodstuff recommend prepar applic place market food food ingredi econom oper follow recommend scientif aspect inform support applic set annex part econom oper ensur inform support applic refer point present accord recommend set annex part ii member state ensur initi assess report drawn compet food assess bodi pursuant articl regul ec prepar accord recommend set annex part iii brussel juli commiss martin bangemann member commiss oj annex part recommend scientif aspect inform support applic place market food food ingredi tabl content page introduct categori food food ingredi identifi regul ec kei issu assess food food ingredi nf gener consider genet modifi organ gmo substanti equival composit analysi intak nutrit consider affect toxicolog test anim toxicolog requir implic nf human nutrit microorgan food allergen potenti assess marker gene scientif classif food assess wholesom class pure chemic simpl mixtur gm sourc class complex nf gm sourc class gm plant product class gm anim product class gm microorgan product class food produc process identif essenti inform assess wholesom specif nf ii effect product process appli nf iii histori organ sourc nf iv effect genet modif properti host organ genet stabil gmo nf sourc vi specif express genet materi vii transfer genet materi gmo page viii abil gmm surviv colon human gut ix anticip intak extent nf inform previou human exposur nf sourc xi nutrit inform nf xii microbiolog inform nf xiii toxicolog inform nf review recommend refer glossari tabl associ categor commun regul food food ingredi scf recommend tabl ii index structur scheme class nf scheme xiii introduct made food put market produc process tradit ingredi implic consum safeti nutrit requir consider inform need issu relat aspect present issu food safeti relat food consider world wide world health organ organ econom cooper develop oecd nation intern bodi address gener specif aspect relev wholesom food number report outlin philosophi develop field refer part develop regul ec food food ingredi european commiss ask scientif committe food scf develop recommend scientif aspect inform support applic place market food food ingredi ii present inform iii prepar initi assess report report cover task categori food food ingredi identifi regul ec regul ec european parliament council januari food food ingredi regul ec appli place market food food ingredi hitherto human consumpt signific degre commun fall categori food food ingredi consist genet modifi organ mean council direct eec food food ingredi produc genet modifi organ food food ingredi intention modifi primari molecular structur food food ingredi consist isol microorgan fungi alga food food ingredi consist isol plant food ingredi isol anim food food ingredi obtain tradit propag breed practic histori safe food food food ingredi appli product process process rise signific composit structur food food ingredi affect nutrit metabol level undesir substanc regul appli food addit fall scope council direct eec flavour foodstuff fall scope council direct eec extract solvent product foodstuff fall scope council direct eec kei issu assess food food ingredi nf gener consider food complex mixtur macro microconstitu provid energi nutrient contribut human tradition regard natur benefici product safeti nutrit question regulatori approach food safeti reflect attitud focus food addit process aid contamin natur industri origin food hitherto systemat subject nutrit toxicolog evalu rare case acut toxic effect report human solanin cyanogen glycosid case anim studi human experi suggest advers effect raw food materi raw soya flour impli nutrit evalu individu food diet perform nutrit evalu basi safeti assess individu food hand food addit permit food subject exhaust toxicolog evalu food toxic compound includ mutagen carcinogen chronic diseas human dietari element etiolog agre advers effect diet health relat pattern nutrient intak exact mechan involv ill health due chronic exposur constitu tradit food recent attent aspect role modifi toxic effect anticarcinogen natur present food assess wholesom food includ food food ingredi nf present number scientif challeng convent toxicolog evalu method appli food food present difficulti encount test food addit contamin vivo vitro amount food incorpor diet anim feed studi perturb nutrit balanc make convent safeti factor inappropri risk assess manag product intend food major food ingredi tradit metabol pharmacokinet studi directli applic complex chemic mixtur food mutagen vitro test food requir special techniqu cautiou interpret result altern approach test assess wholesom food major food ingredi need ultim strategi combin nutrit toxicolog test extend initi test vitro vivo studi anim model studi human need genet modifi organ gmo council direct eec eec amend commiss direct ec set inform requir safeti contain genet modifi microorgan gmm safeti deliber releas genet modifi organ gmo requir direct relev gmo cover regul ec food food ingredi fulfil basic inform requir need safeti assess nf present recommend specif focu aspect relev human food safeti issu substanti equival concept substanti equival introduc oecd refer food produc modern biotechnolog terminolog oecd concept substanti equival embodi idea exist organ food food sourc serv basi comparison assess safeti human consumpt food food compon modifi food food compon found substanti equival exist food food compon treat manner respect safeti keep mind establish substanti equival safeti nutrit assess approach compar potenti food convent counterpart applic principl substanti equival extend evalu food sourc process substanti equival nf compar term safeti convent counterpart substanti equival establish food food compon includ introduc chang establish food food compon specif chang introduc nf found substanti equival exist food food compon impli unsaf nf evalu basi uniqu composit properti establish substanti equival analyt exercis assess rel wholesom nf compar exist food food compon dynam element continu modif food requir basi comparison evolv recent nf compar nf necessarili tradit counterpart comparison simpl task lengthi depend experi natur nf consider technic approach establish substanti equival differ anim plant microorgan chemic food ingredi process address detail class recommend composit analysi analyt studi composit nf crucial import establish substanti equival prerequisit nutrit toxicolog assess method appli standard valid ensur qualiti consist data analys data present base sound scientif principl tailor natur nf investig focu determin content critic nutrient macro micronutri critic toxic anti nutrit factor inher present process deriv intak consumpt pattern show major chang nf includ diet affect human nutrit statu predict event surveil programm accompani market nf programm encompass inform condit process prepar effect replac food food compon dietari import surveil reveal factor rais concern wholesom reapprais accept nf requir nutrit consider affect toxicolog test anim evalu crucial import interpret carefulli advers effect anim studi distinguish toxic effect due nutrit imbal experiment diet nutrit toxicolog aspect close integr assess nf knowledg nutrit properti nf energi protein content bioavail micronutri need prerequisit toxicolog test programm design anim feed studi maximum level dietari incorpor achiev caus nutrit imbal highest dose level lowest dose level compar anticip role human diet predict usag level consum intak high applic tradition calcul safeti factor emploi safeti assess creat difficulti design convent anim feed studi adequ dietari incorpor level ensur clearanc human anticip consumpt level compens inabl emploi adequ safeti factor subchron chronic anim feed studi requir supplement absorpt metabol studi anim eventu human holist scientif interpret wholesom assess data case case basi provid accept justif safeti factor nf lower tradition safeti assess toxicolog requir principl toxicolog requir nf consid case case basi establish provis toxicolog data scenario consid substanti equival establish accept tradit food food ingredi case test need substanti equival establish singl specif trait nf case assess safeti focu specif trait partial total substanti equival establish case wholesom food macronutri assess combin nutrit toxicolog approach substanti equival tradit counterpart establish wholesom assess account knowledg ident chemic structur physico chemic properti nf aspect sourc composit potenti intak base propos gener diet potenti exposur vulner popul group effect process greater predict dietari exposur extens requir toxicolog test programm implic nf human nutrit assess nutrit implic expect customari normal intak maximum level consumpt evalu guid apprais relev literatur composit analys comparison substanti equival need data investig anim model nf expect import role diet human nutrit assess data need attent paid physiolog characterist metabol requir group infant children pregnant lactat women elderli chronic diseas diabet mellitu malabsorpt inform need long term short term effect eat nf inform deriv combin nutrit safeti post market surveil addition consider address effect specif concern nutrit qualiti long term effect fat replac metabol fat solubl vitamin microorgan food microorgan produc food food ingredi food addit long tradit safe food ferment kill ferment product consum aliv definit microorgan tradit food product europ substanti equival counterpart europ assess relev criteria contain limit fermentor remain aliv food kill process potenti colon mammalian gut potenti toxigen pathogen mammal genet engin appli genet modif emploi consider potenti transfer genet materi gmm vii relev safeti assess gmm origin newli introduc materi vector regulatori element foreign gene includ target marker gene case consid homolog system clone genet element involv deriv strain taxonom speci heterolog system donor organ genet element belong taxonom speci recipi gener segreg horizont stabil construct interest clone organ concept substanti equival applic case heterolog system safeti gene product relat effect food effect trait properti microorgan food ingest gut assess implic horizont gene transfer gut analyz evalu allergen potenti potenti occurr allerg reaction protein constitu nf explor gener principl assess immunolog reactiv individu react tradit food counterpart test vitro vivo nf approach rais ethic issu account protein express gene drive sourc food allergi sera peopl confirm allergi sourc subject specif immunolog test western blot radioallergosorb test rast vitro test neg vivo skin prick test clinic supervis doubl blind placebo control challeng peopl perform studi compli relev element ethic principl guidelin good clinic practic good laboratori practic number factor serv indic potenti allergen protein sequenc epitop homolog allergen heat stabil sensit ph digest gastrointestin proteas detect amount plasma molecular weight addit evid emerg pre market human result report worker sensit approach need assess potenti allergen nf human present state knowledg allergen food gm sourc includ consider allergen potenti donor recipi organ assess marker gene marker gene tag identifi select cell plant microorgan transform successfulli genet modif suppos plai role final product nf marker gene present frequent plant confer resist antibiot increas toler herbicid confer heavi metal toler phenotyp biochem select requir evalu safeti marker gene basic similar applic safeti evalu foreign gene assess plant marker gene product encod method analyz quantifi marker gene express product food potenti toxicolog nutrit effect relat function marker gene potenti horizont gene transfer gut microorgan marker gene microorgan gene confer antibiot resist assess relat host organ biolog contain establish genet construct possibl colon human gut gmo relationship efficaci antimicrobi acquir resist foreseen list approv marker gene develop base evalu primari effect host organ secondari effect host depend factor insert site host dna assess case case basi reason suppos potenti secondari effect greater marker gene insert gene scientif classif food assess wholesom food food ingredi fall scope regul ec food food ingredi divers section facilit safeti nutrit evalu class nf identifi differ complex issu address purpos recommend term plant cover seawe term anim includ fish shellfish term microorgan encompass bacteria fungi includ yeast micro alga virus plasmid scope guidelin class pure chemic simpl mixtur gm sourc class compris food food compon singl chemic defin substanc mixtur obtain plant anim microorgan genet modifi class identifi sourc nf histori food commun sourc nf histori food commun class complex nf gm sourc class compris complex nf deriv sourc genet modifi intact plant anim microorgan food food compon complex carbohydr fat protein substanc collect dietari fibr includ class identifi sourc nf histori food commun sourc nf histori food commun class gm plant product gm plant consum directli unprocess food process food food ingredi includ pure chemic class nf includ food food ingredi class identifi host plant genet modif histori food sourc food commun compar condit prepar intak host plant genet modif histori food sourc food commun compar condit prepar intak class gm anim product gm anim consum directli unprocess food process food food ingredi includ pure chemic product directli produc gm anim egg milk consum process unprocess class nf includ food food ingredi class identifi host anim genet modif histori food sourc food commun compar condit prepar intak host anim genet modif histori food sourc food commun compar condit prepar intak class gm microorgan product live gm microorgan food product product food ingredi class includ nf produc gm microorgan live cell nf consum class identifi host microorgan genet modif histori food sourc food commun compar condit prepar intak host microorgan genet modif histori food sourc food commun compar condit prepar intak class food produc process class compris food food ingredi subject process food product process food product encompass type heat process thermal preserv method process chill freez product dehydr product applic process catalyz enzym scope regul ec result product consid nf process result chemic composit structur food food ingredi affect nutrit metabol level undesir substanc associ class categor regul ec food food ingredi outlin tabl identif essenti inform assess wholesom section structur scheme provid identifi type inform requir establish safeti class nf recogn formalist approach cover adequ nf scheme provid guidanc inform relev assess submit propos omit inform dossier request scheme scientif justif result investig relev safeti assess carri report assess nf focu novelti se chemic microbiolog contamin nf specif relat novelti address recommend similarli presenc microbi toxin microbi viral infect agent consid consequ novelti identif essenti inform assess guid divis class chapter alloc nf class class attach tabl ii determin structur scheme xiii consult provid inform requir support safeti nutrit evalu inform request structur scheme detail specif nf specif origin composit nf need ensur ident product test evalu product market design specif paramet relev character product safeti nutrit point view consid paramet includ speci taxon chemic composit relat nutrit properti antinutrit toxicolog concern taxonom ident establish referenc internation accept principl deviat principl explain inform avail refer materi submit ii effect product process appli nf principl scheme appli nf process product descript technic detail suffici detail permit distinct exist process ii predict potenti process introduc physic chemic biolog food impact essenti nutrit toxicolog microbiolog paramet final product assess technolog address organ inorgan residu contamin deriv apparatu equip chemic physic biolog aid process critic aspect product process relat nf ensur final product process compli specif scheme hygien paramet includ assess nf cover direct eec assess focu food product result process case case basi ultim aim assess evalu process wider sens test assess conceiv food process combin impli broader strategi repres relev food class process food process compar untreat counterpart counterpart process relat tradit manner iii histori organ sourc nf novelti food plant food anim food microorgan relat guidelin defin novelti european food suppli speci taxon plant anim microorgan gener recognis diet commun countri nation dietari record speci taxon consid full descript need assess futur role european food suppli includ inform past present plant anim microorgan product food suppli part world inform includ past present method obtain raw materi food rais harvest slaughter captur procedur ferment prepar descript transport storag condit tradit role diet locat commun iv effect genet modif properti host organ inform gather scheme focus effect genet modif properti gmo compar host organ differenti intend unintend effect case special attent nutrit toxicolog microbiolog impact food gm plant principl evalu gm plant product similar valid gm plant product safeti evalu gm plant simpler task evalu gm plant modifi organ tradit food plant alter occur mean precis defin process genet modif case safeti assess focu result genet modif genet modif result phenotyp composit consequ modif defin test genet modifi plant design express natur occur insecticid encod gene deriv organ resist insect pest toxicolog profil introduc insecticid compon determin safeti modif chemic composit evalu standard toxicolog procedur includ assess potenti allergen addit secondari effect posit effect consider effect insert event insert mutat genom rearrang influenc outcom genet modif knowledg normal toxin product plant effect growth cultur condit gm plant subject knowledg gene product appear final food essenti reason appli nutrition import compon food plant essenti step safeti evalu character parent food organ character molecular level natur genet modif includ insert posit copi number biochem express level establish substanti equival parent food organ deriv chemic phenotyp analysi substanti equival establish convent safeti studi specif chemic occur food due phenotyp involv product gene safeti inher natur toxin present alter amount potenti allergen compon address gm anim gener principl establish safeti evalu gm plant appli gm anim safeti assess initi address establish substanti equival parent organ gm organ focuss primari secondari effect genet modif process modif direct chang globulin cow milk human type globulin assess fish genet modifi produc antifreez protein safeti chemic modif evalu convent toxicolog strategi includ assess allergen aspect gm microorgan complianc provis set gm plant gm anim parent microorgan subject genet modif priori recogn microorgan tradit food ferment commun pathogen biolog advantag human intestin commens tradition product organ food includ food addit technic aid simplifi evalu procedur case genet modif parent microorgan assess genet stabil gmo nf sourc question genet stabil relat structur local mainten introduc genet materi gene express gmo vi specif express genet materi scheme relat factor involv regul gene express instanc organ tissu specif condit repress activ vii transfer genet materi gmo base current knowledg consider gene transfer gmo human gut focu microorgan horizont gene transfer microorgan establish consid food safeti assess aspect biolog contain transfer genet materi gm microorgan human gut microflora possibl address aspect experiment set anim vitro gut model assess food safeti consequ gene transfer natur gene product frequenc transfer level express transform gut microorgan account transfer gene plant microorgan theoret possibl consequ event consid viii abil gmm surviv colonis human gut genet modif facilit surviv passag intestin colon human gut antagonist synergist effect composit intestin flora occur influenc human health experiment data requir respect properti gmo live gmm food attent focu capabl surviv colon gastrointestin tract maintain genom stabil assess vitro vivo gut model mimick human situat close need aspect relat pathogen gastrointestin immun special consider ix anticip intak extent nf project anticip intak need evalu dietari nutrit signific nf assess natur draw inform natur nf anticip base properti fat replac inform previou human exposur nf sourc document previou nf sourc commun nf sourc nf part world import establish baselin assess histori food commun guarante nf safe consum commun inform deal aspect tradit handl prepar plant anim microorgan prevent misus advers short long term health effect due inher antinutrit toxic factor case precaut reflect region cultur habit xi nutrit inform nf assess includ systemat review nf composit prepar role expect diet assess review relev publish materi enabl apprais substanti equival tradit food food compon substanti equival establish preliminari assess made anim model establish aspect nutrit qualiti full nutrit assess human subject studi base defin hypothes clear nutrit metabol outcom relev nf dietari context anticip consum group nutrit consequ assess normal maximum level consumpt nutrient composit data account effect storag process cook effect antinutrit factor inhibit miner absorpt bioavail nutrit diet assess number involv studi group ensur studi adequ statist power studi compli relev element ethic principl guidelin good clinic practic good laboratori practic circumst envisag plan provid post market surveil long term effect nf xii microbiolog inform nf addit toxicolog nutrit safeti wholesom nf embrac microbiolog safeti gener intention sourc organ nf recognis pathogen toxigen microorgan genet stabil affect desir properti normal intestin flora examin nf includ character microorgan present analysi metabolit xiii toxicolog inform nf scheme cover set toxicolog inform need assess nf rang scenario extend food substanti equival establish food substanti equival establish requir nutrit toxicolog test program substanti equival tradit counterpart establish safeti assess base case case evalu element consider toxic analyt identifi individu chemic compon toxic studi vitro vivo includ mutagen studi reproduct teratogen studi long term feed studi tier approach case case basi studi potenti allergen case microconstitu isol food compon differ identifi characterist tradit food defin product obtain genet modifi organ restrict test product substanc nf case test properti margin nutrit implic laboratori anim tradit toxicolog approach appli establish safeti defin chemic substanc test safeti similarli food addit util convent method safeti evalu scf report impli convent toxicolog test procedur appli tier sequenc involv initi mutagen studi feed studi rodent speci exhaust investig relev toxicolog paramet warrant structur exposur consider addit investig undertaken cover usual toxicolog endpoint includ metabol toxicokinet chronic toxic carcinogen reproduct function teratogen possibl neurotox immunotox macroconstitu nf substanti equival tradit counterpart requir test programm depend toxicolog concern rais gener programm includ dai feed studi rodent speci special attent paid choic dose avoid problem nutrit imbal constraint requir conduct toxicolog studi interpret result potenti mutagen investig vitro mutagen studi cover usual major endpoint special technic problem encount test macroconstitu vitro mutagen test system effect nf constitu growth medium test cell test organ unrel mutagen case feed studi speci investig effect composit intestin flora need chronic toxic carcinogen studi allergen potenti investig review recommend area food develop rapidli scienc technolog make enorm advanc countri intern organis elabor procedur guidelin safeti assess food scf review recommend light experi gain applic scientif develop field refer intern food biotechnolog council ifbc biotechnolog food assur safeti food produc genet modif reg tox pharm report joint fao consult strategi assess safeti food produc biotechnolog geneva guidelin assess food process acnfp london nordic work group food toxicolog risk assess nnt food biotechnolog novelti safeti control aspect food made biotechnolog nord copenhagen statement polici food deriv plant varieti depart health human servic food drug administr feder regist guidelin food food addit produc recombin dna techniqu japan kok evalu strategi food safeti assess genet modifi agricultur product report rikilt dlo wageningen safeti evalu food deriv modern biotechnolog concept principl oecd pari report workshop health aspect marker gene genet modifi plant geneva netherland food nutrit council advisori report biotechnolog hagu juli panel food committe medic aspect food polici nutrit assess food process hmso london thoma myer ed biotechnolog safeti assess raven press york aquat biotechnolog food safeti oecd document pari guidelin safeti assess food food director health protect branch canada advisori committe food process acnfp report antibiot resist marker genet modifi food organ maff public london juli advisori committe food process acnfp annual report maff public london report workshop applic principl substanti equival safeti evalu food food compon plant deriv modern biotechnolog geneva jone ed proceed intern symposium biosafeti result field test genet modifi plant microorgan univers california oakland ca engel takeoka teranishi ed genet modifi food safeti aspect american chemic societi symposium seri washington dc safeti assess food guidelin prepar ilsi europ food task forc oecd workshop food safeti evalu food safeti evalu oecd document health effect marker gene genet engin food plant temanord nordic council minist copenhagen glossari glossari intend explain term scf recommend provid precis scientif definit gt tabl gt gt tabl gt gt tabl gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt gt refer graphic gt part ii recommend scientif aspect present inform support applic place market food food ingredi introduct part scf recommend assess food recommend scientif aspect inform support applic place market food food ingredi nf present part recommend scientif aspect present inform summar uniform structur applic facilit scientif evalu gener scheme emphasis part recommend formalist approach adequ cover nf scheme develop consid rigid checklist provid guidanc underli philosophi major principl recommend reflect applic place nf market box illustr logic flow gt start graphic gt gener descript nf includ technic data categor regul ec alloc nf scf class class identif essenti inform requir consult structur scheme decis tree provis data requir evalu conclus applic gt end graphic gt inform packag submit applic present order head administr data section includ inform address applic manufactur nf person respons dossier gener descript order ensur food food ingredi intend market fall scope regul ec food food ingredi data provid enabl categor articl regul ec facilit assess procedur scf reclassifi divers categori defin legisl similar term safeti consider major class class defin chapter scf recommend assess food part refer part nf alloc class class tabl part scientif justif alloc identif essenti inform requir tabl ii part determin scheme xiii essenti provid data permit safeti nutrit evalu nf consult structur scheme decis tree structur scheme xiii elabor part consult data assembl scheme lead decis tree set question assist decid data applic suffici inform sought reapprais logic scheme dossier box inform lead provid detail propos omit inform request scheme scientif justif inform consid relev assess submit evalu conclus applic conclus drawn applic evalu total inform assembl present cover kei issu relev nf chapter part summari applic summari provid suitabl circul member state foreseen articl regul ec part iii recommend scientif aspect prepar initi assess report applic place market food food ingredi introduct regul ec food food ingredi stipul articl person respons place product commun market submit request action member state product market time provis articl member state prepar initi assess report part scf recommend assess food present recommend scientif aspect inform support applic place market food food ingredi nf part ii summaris recommend scientif aspect present inform experi assess safeti food gain appli procedur nation intern bodi author practic purpos achiev compar assess nation author uniform report scientif apprais detail requir type nf provid part regard product produc genet modif sourc protein specif recommend safeti test made class nf current state knowledg case case approach ensur risk adequ address part iii intend provid guidanc task recommend scientif aspect prepar initi assess report compet author member state structur initi assess report gener consider underli assess nf set part section initi assess report confin human food safeti nf prepar proce phase check complet applic present accord part ii apprais appropri interpret evalu applic data submit assess data submit execut summari conclus recommend check complet applic present accord part ii initi assess report provid statement submiss administr technic detail present order laid part ii section inform set part section data submit differ request part ii present order requir applic explan review apprais appropri interpret evalu applic data submit adequaci data argument relat interpret evalu applic assess opinion provid event disagr interpret evalu nation assess author applic pertin reason fulli assess report substanti equival assess purpos comparison final product accept standard safeti furnish import element initi assess report includ compet author opinion applic claim substanti equival substanti equival tradit counterpart claim guidanc relev discuss part section consult substanti equival tradit counterpart establish nf regard wholesom toxicolog nutrition accept diet manner compar counterpart replac counterpart judg compar nf counter part limit measur natur divers convent counterpart account substanti equival defin trait claim substanti equival defin trait establish assess focu trait evalu case case basi case requir data match need safeti evalu food addit substanti equival claim substanti equival tradit food food ingredi claim nf requir extens test detail outlin part special consider food substanti equival exist food data evalu nf requir consider target specif defin trait nf inform provid applic assess light origin method product complex nf role diet popul larg group nutrit assess special attent paid expect consumpt level nf potenti nutrit impact part section xi check effect consumpt nf total dietari intak nutrient pri popul refer intak accept rang intak establish assess specif popul group compet author evalu document anim model human metabol studi includ clinic observ long term short term effect nf human nutrit consid attent paid occurr unexpect advers interfer dietari constitu relev biomark assess microorgan food nf live microorgan scrutini author confirm applic adequ data safeti microorgan data submit categoris principl substanti equival part assess toxic allergen evalu address data toxic allergen defin trait nf entir nf inform assess wholesom nf discuss part section xiii applic scrutin adequaci data present opinion data formul process product process evalu basi concept substanti equival part ii assess data submit execut summari conclus recommend assess report includ opinion adequaci complet data provid compet author prepar execut summari assess report accompani statement conclus recommend includ condit market addit benefit claim applic pitfal discuss briefli refer biotechnolog food safeti report joint fao consult pag unu guidelin jona paper oj oj oj oj oj oj oj oj