council direct april fix guidelin assess product anim nutrit eec council european commun regard treati establish european econom commun regard council direct eec june product anim nutrit articl thereof regard propos commiss direct eec product belong group examin basi dossier forward offici member state commiss dossier make verifi product question compli gener principl laid direct respect inclus product annex found provid dossier compil accord common guidelin defin principl scientif data make identifi character product concern studi order evalu nutrit properti biolog effect guidelin applic date direct eec enter forc guidelin intend primarili gener guid depend natur product condit extent studi order evalu properti effect vari guidelin drawn basi present scientif technic knowledg adapt develop sphere adopt direct articl member state prescrib dossier product list point annex direct eec compil accord guidelin set annex hereto articl member state bring forc law regul administr provis order compli direct juli latest forthwith inform commiss thereof articl direct address member state luxembourg april council presid kiechl oj annex guidelin assess product anim nutrit gener aspect quot guidelin quot constitut guid intend establish dossier product list item annex direct eec obtain cultur micro organ admit sourc protein anim nutrit dossier enabl assess product base present state knowledg ensur complianc fundament principl laid permit subject articl abovement direct studi outlin document requir addit inform request gener rule inform establish ident micro organ composit cultur medium manufactur process characterist present condit method determin nutrit properti product provid appli inform assess toler product target speci risk man environ result directli indirectli product toxicolog studi requir purpos depend natur product anim speci concern metabol product laboratori anim document provid includ detail report present order number propos guidelin accompani summari omiss propos studi justifi public quot refer attach observ term quot product quot guidelin refer proteinac product state present feedingstuff compon feedingstuff modif manufactur process condit product requir notif addit document assess present studi micro organ cultur medium manufactur process characterist product presentationand condit method determin ii studi nutrit properti product iii studi biolog consequ product anim nutrit iv relev studi section micro organ cultur medium manufactur process characterist product present condit method determin micro organ classif proven morpholog biolog properti genet manipul innocu surviv ferment environment consequ constanc puriti strain cultiv method check criteria cultur medium manufactur process composit substrat ad substanc manufactur dessic purif process devit process micro organ method check constanc composit cultur product detect anychem physic biolog contamin product technic process prepar characterist product physic physico chemic properti macro micro morpholog particl size densiti specif weight hygroscop solubl electrostat properti chemic composit characterist content moistur crude protein crude fat crude cellulos crude ash carbohydr limit ofvari content content total ammonium amid nitrat nitrit nitrogen nucleic acid protein qualitativeand quantit composit total free amino acid purin pyrimidin base qualit quantit composit total lipid fatti acid saponifi matter lipidsolubl pigment phospholipid composit carbohydr fraction qualit quantit composit inorgan compon qualit quantit composit vitamin qualit quantit composit constitu addit residu substrateand solvent potenti harm residu metabol substrat culturemedium manufactur process microbiolog contamin product behaviour stabil product mix feedingstuff current storag present condit propos name market product propos formul market product intend product anim nutrit intend concentr completefeedingstuff intend quantiti daili ration anim speciesconcern method determin qualit quantit method determin product complet andcomplementari feedingstuff nb descript method accompani inform specif sensit limit detect margin error interfer substanc sampl product propos present section ii studi nutrit properti product assess protein chemic biochem microbiolog studi studi laboratori anim compar refer protein studi target speci studi perform target speci comparison controlgroup receiv condit nutrit balanc diet current containingequival amount protein nitrogen rumin total nitrogen protein energi supplement product ration proposedcondit physiolog stage anim grow period pregnanc lai influenc product propos condit growth rate feed convers rate morbid mortal optimum nutrit level incorpor product ration effect product propos condit technolog organolept oroth qualiti edibl product anim origin experiment condit studi target speci give detail descript test perform provid data speci breed ag sex anim identif procedur number test control group number anim group number largeenough statist analysi suitabl statist paramet level incorpor product qualit quantit composit ration andit analysi locat experi physiolog state anim health condit rear condit reflect practic commun exact durat test date analys perform advers effect occur experi time appear section iii studi biolog consequ product anim nutrit studi outlin section intend permit assess safeti product target speci risk man environ result directli indirectli toxicolog studi requir purpos depend natur product anim speci concern metabol product laboratori anim studi target speci studi perform target speci comparison controlgroup receiv condit nutrit balanc diet current containingequival amount protein nitrogen rumin total nitrogen maximum incorpor rate product daili ration produc adverseeffect effect product fertil reproduct effect ingest product propos condit micro organ theflora alimentari tract colon pathogen alimentari tract investig propos condit residu product substrat cultur medium solvent contamin edibl product anim origin investig propos condit residu product substrat cultur medium solvent contamin excreta studi laboratori anim metabol fate product anim absorpt accumul biotransform elimin mutagen investig potenti mutagen due contamin mycotoxin andbacteria residu product substrat cultur medium solvent includ vitroscreen test metabol activ system toxicolog studi studi perform comparison control group receiv thesam condit nutrit balanc diet current equival amount ofprotein nitrogen toxic effect investig elucid mechan andto ascertain result nutrit imbal overdosag productin diet subchron toxic dai gener studi carri anim speci rodent product administ daili ration level incorpor theseshould chosen determin effect level level show adverseeffect anim group adequ number subject sex controlgroup includ relev biolog data record interv data growthrat feed consumpt haematolog urin analysi biochem paramet mortal organ weight gross patholog histopatholog major organ tissu result bepres detail includ statist assess chronic toxic gener chronic toxic studi carri anim speci beinga rodent product admininst daili ration level ofincorpor experi extend minimum year rat week inmic anim group adequ number subject sex controlgroup includ biolog examin mention point carri prefer asmal satellit group anim group separ depend main group atappropri interv experi surviv anim end theexperi carcinogen assess carcinogen attent paid time appear thehistolog type observ tumour incid effect incid oftumour incid progress diseas assess refer controlgroup paragraph result present detail asposs includ statist assess studi reproduct studi extend filial gener combin withembryotox includ teratogen studi attent paid fertil fecund observ post natal develop litter method isscientif justifi produc measur result relai toxic beprovid experiment condit studi laboratori anim give detail descript test perform provid data speci breed strain sex anim number test control group number anim group number largeenough statist analysi suitabl statist paramet level incorpor product qualit quantit composit ration andit analysi gener rear condit period test exact durat test date examin perform rate time death test group clinic symptom patholog alter occur experi time oftheir appear studi environ depend natur residu product substrat cultur medium solvent contamin excreta target speci data fate residu manur soil andwat effect soil biologi plant growth aquat life requir section iv relev studi depend natur condit product data allerg effect irrit skin mucu membran ey respiratori digest tract requir assess risk handl product prevent