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1、-1-GUIDELINEFORTHECONDUCTOFFOODSAFETYASSESSMENTOFFOODSDERIVEDFROMRECOMBINANT-DNAPLANTSCAC/GL45-2003SECTION1-SCOPE1.ThisGuidelinesupportsthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Itaddressessafetyandnutritionalaspectsoffoodsconsistingof,orderivedfrom
2、,plantsthathaveahistoryofsafeuseassourcesoffood,andthathavebeenmodifiedbymodernbiotechnologytoexhibitneworalteredexpressionoftraits.2.Thisdocumentdoesnotaddressanimalfeedoranimalsfedwiththefeed.Thisdocumentalsodoesnotaddressenvironmentalrisks.3.TheCodexprinciplesofriskanalysi
3、s,particularlythoseforriskassessment,areprimarilyintendedtoapplytodiscretechemicalentitiessuchasfoodadditivesandpesticideresidues,oraspecificchemicalormicrobialcontaminantthathaveidentifiablehazardsandrisks;theyarenotintendedtoapplytowholefoodsassuch.Indeed,fewfoodshavebeenas
4、sessedscientificallyinamannerthatwouldfullycharacteriseallrisksassociatedwiththefood.Further,manyfoodscontainsubstancesthatwouldlikelybefoundharmfulifsubjectedtoconventionalapproachestosafetytesting.Thus,amorefocusedapproachisrequiredwherethesafetyofawholefoodisbeingconsidere
5、d.4.Thisapproachisbasedontheprinciplethatthesafetyoffoodsderivedfromnewplantvarieties,includingrecombinant-DNAplants,isassessedrelativetotheconventionalcounterparthavingahistoryofsafeuse,takingintoaccountbothintendedandunintendedeffects.Ratherthantryingtoidentifyeveryhazardas
6、sociatedwithaparticularfood,theintentionistoidentifyneworalteredhazardsrelativetotheconventionalcounterpart.5.ThissafetyassessmentapproachfallswithintheriskassessmentframeworkasdiscussedinSection3ofthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnology.Ifanewora
7、lteredhazard,nutritionalorotherfoodsafetyconcernisidentifiedbythesafetyassessment,theriskassociatedwithitwouldfirstbeassessedtodetermineitsrelevancetohumanhealth.Followingthesafetyassessmentandifnecessaryfurtherriskassessment,thefoodwouldbesubjectedtoriskmanagementconsiderati
8、onsinaccordancewiththePrinciplesfortheRiskAnalysisofFoodsDerivedfrom
