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1、-1-PRINCIPLESFORTHERISKANALYSISOFFOODSDERIVEDFROMMODERNBIOTECHNOLOGYCAC/GL44-2003SECTION1-INTRODUCTION1.Formanyfoods,theleveloffoodsafetygenerallyacceptedbythesocietyreflectsthehistoryoftheirsafeconsumptionbyhumans.Itisrecognisedthatinmanycasestheknowledgerequiredtoman
2、agetherisksassociatedwithfoodshasbeenacquiredinthecourseoftheirlonghistoryofuse.Foodsaregenerallyconsideredsafe,providedthatcareistakenduringdevelopment,primaryproduction,processing,storage,handlingandpreparation.2.Thehazardsassociatedwithfoodsaresubjectedtotheriskanal
3、ysisprocessoftheCodexAlimentariusCommissiontoassesspotentialrisksand,ifnecessary,todevelopapproachestomanagetheserisks.Theconductofriskanalysisis1guidedbygeneraldecisionsoftheCodexAlimentariusCommissionaswellastheCodexWorkingPrinciplesforRisk2Analysis.3.Whileriskanalys
4、ishasbeenusedoveralongperiodoftimetoaddresschemicalhazards(e.g.residuesofpesticides,contaminants,foodadditivesandprocessingaids),anditisbeingincreasinglyusedtoaddressmicrobiologicalhazardsandnutritionalfactors,theprincipleswerenotelaboratedspecificallyforwholefoods.4.T
5、heriskanalysisapproachcan,ingeneralterms,beappliedtofoodsincludingfoodsderivedfrommodernbiotechnology.However,itisrecognisedthatthisapproachmustbemodifiedwhenappliedtoawholefoodratherthantoadiscretehazardthatmaybepresentinfood.5.Theprinciplespresentedinthisdocumentshou
6、ldbereadinconjunctionwiththeCodexWorkingPrinciplesforRiskAnalysistowhichtheseprinciplesaresupplemental.6.Whereappropriate,theresultsofariskassessmentundertakenbyotherregulatoryauthoritiesmaybeusedtoassistintheriskanalysisandavoidduplicationofwork.SECTION2–SCOPEANDDEFIN
7、ITIONS7.ThepurposeofthesePrinciplesistoprovideaframeworkforundertakingriskanalysisonthesafetyandnutritionalaspectsoffoodsderivedfrommodernbiotechnology.Thisdocumentdoesnotaddressenvironmental,ethical,moral3andsocio-economicaspectsoftheresearch,development,productionand
8、marketingofthesefoods.8.ThedefinitionsbelowapplytothesePrinciples:“ModernBiotechnology”meanstheapplicationof:i)Invitr
