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1、CAC/GL45Page1of14DRAFTGUIDELINEFORTHECONDUCTOFFOODSAFETYASSESSMENTOFFOODSDERIVEDFROMRECOMBINANT-DNAPLANTSCAC/GL45-2003SECTION1-SCOPE1.ThisGuidelinesupportsthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Itaddressessafetyandnutritionalaspectsoffoodsconsisting
2、of,orderivedfrom,plantsthathaveahistoryofsafeuseassourcesoffood,andthathavebeenmodifiedbymodernbiotechnologytoexhibitneworalteredexpressionoftraits.2.Thisdocumentdoesnotaddressanimalfeedoranimalsfedwiththefeed.Thisdocumentalsodoesnotaddressenvironmentalrisks.3.TheCodexprinciples
3、ofriskanalysis,particularlythoseforriskassessment,areprimarilyintendedtoapplytodiscretechemicalentitiessuchasfoodadditivesandpesticideresidues,oraspecificchemicalormicrobialcontaminantthathaveidentifiablehazardsandrisks;theyarenotintendedtoapplytowholefoodsassuch.Indeed,fewfoods
4、havebeenassessedscientificallyinamannerthatwouldfullycharacteriseallrisksassociatedwiththefood.Further,manyfoodscontainsubstancesthatwouldlikelybefoundharmfulifsubjectedtoconventionalapproachestosafetytesting.Thus,amorefocusedapproachisrequiredwherethesafetyofawholefoodisbeingco
5、nsidered.4.Thisapproachisbasedontheprinciplethatthesafetyoffoodsderivedfromnewplantvarieties,includingrecombinant-DNAplants,isassessedrelativetotheconventionalcounterparthavingahistoryofsafeuse,takingintoaccountbothintendedandunintendedeffects.Ratherthantryingtoidentifyeveryhaza
6、rdassociatedwithaparticularfood,theintentionistoidentifyneworalteredhazardsrelativetotheconventionalcounterpart.5.ThissafetyassessmentapproachfallswithintheriskassessmentframeworkasdiscussedinSection3ofthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Ifanewor
7、alteredhazard,nutritionalorotherfoodsafetyconcernisidentifiedbythesafetyassessment,theriskassociatedwithitwouldfirstbeassessedtodetermineitsrelevancetohumanhealth.Followingthesafetyassessmentandifnecessaryfurtherriskassessment,thefoodwouldbesubjectedtoriskmanagementconsideration
8、sinaccordancewiththePrinciplesfortheRiskAnalysi
