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1、CAC/GL44-2003Page1of4PRINCIPLESFORTHERISKANALYSISOFFOODSDERIVEDFROMMODERNBIOTECHNOLOGYCAC/GL44-2003SECTION1-INTRODUCTION1.Formanyfoods,theleveloffoodsafetygenerallyacceptedbythesocietyreflectsthehistoryoftheirsafeconsumptionbyhumans.Itisrecognisedthatinmanycasestheknow
2、ledgerequiredtomanagetherisksassociatedwithfoodshasbeenacquiredinthecourseoftheirlonghistoryofuse.Foodsaregenerallyconsideredsafe,providedthatcareistakenduringdevelopment,primaryproduction,processing,storage,handlingandpreparation.2.Thehazardsassociatedwithfoodsaresubj
3、ectedtotheriskanalysisprocessoftheCodexAlimentariusCommissiontoassesspotentialrisksand,ifnecessary,todevelopapproachestomanagetheserisks.The1conductofriskanalysisisguidedbygeneraldecisionsoftheCodexAlimentariusCommission(CAC)as2wellastheCodexWorkingPrinciplesforRiskAna
4、lysis.3.Whileriskanalysishasbeenusedoveralongperiodoftimetoaddresschemicalhazards(e.g.residuesofpesticides,contaminants,foodadditivesandprocessingaids),anditisbeingincreasinglyusedtoaddressmicrobiologicalhazardsandnutritionalfactors,theprincipleswerenotelaboratedspecif
5、icallyforwholefoods.4.Theriskanalysisapproachcan,ingeneralterms,beappliedtofoodsincludingfoodsderivedfrommodernbiotechnology.However,itisrecognisedthatthisapproachmustbemodifiedwhenappliedtoawholefoodratherthantoadiscretehazardthatmaybepresentinfood.5.Theprinciplespres
6、entedinthisdocumentshouldbereadinconjunctionwiththeCodexWorkingPrinciplesforRiskAnalysistowhichtheseprinciplesaresupplemental.6.Whereappropriate,theresultsofariskassessmentundertakenbyotherregulatoryauthoritiesmaybeusedtoassistintheriskanalysisandavoidduplicationofwork
7、.SECTION2–SCOPEANDDEFINITIONS7.ThepurposeofthesePrinciplesistoprovideaframeworkforundertakingriskanalysisonthesafetyandnutritionalaspectsoffoodsderivedfrommodernbiotechnology.Thisdocumentdoesnotaddressnvironmental,ethical,moralandsocio-economicaspectsoftheresearch,deve
8、lopment,productionand3marketingofthesefoods.8.ThedefinitionsbelowapplytothesePrinciples:1ThesedecisionsincludetheStat