CAC GL 46-2003GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT

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1、-1-GUIDELINEFORTHECONDUCTOFFOODSAFETYASSESSMENTOFFOODSPRODUCEDUSINGRECOMBINANT-DNAMICROORGANISMSCAC/GL46-2003SECTION1–SCOPE1.ThisGuidelinesupportsthePrinciplesfortheRiskAnalysisofFoodsDerivedfromModernBiotechnologyand1addressessafetyandnutritionalasp

2、ectsoffoodsproducedthroughtheactionsofrecombinant-DNAmicroorganisms.Therecombinant-DNAmicroorganismsthatareusedtoproducethesefoodsaretypicallyderivedusingthetechniquesofmodernbiotechnologyfromstrainsthathaveahistoryofsafe,purposefuluseinfoodproductio

3、n.However,in2instanceswheretherecipientstrainsdonothaveahistoryofsafeusetheirsafetywillhavetobeestablished.Suchfoodandfoodingredientsmaycontainviableornon-viablerecombinant-DNAmicroorganismsormaybeproducedbyfermentationusingrecombinant-DNAmicroorgani

4、smsfromwhichtherecombinant-DNAmicroorganismsmayhavebeenremoved.2.Recognizingthatthefollowingissuesmayhavetobeaddressedbyotherbodiesorotherinstruments,thisdocumentdoesnotaddress:•safetyofmicroorganismsusedinagriculture(forplantprotection,biofertilizer

5、s,inanimalfeedorfoodderivedfromanimalsfedthefeedetc.);•risksrelatedtoenvironmentalreleasesofrecombinant-DNAmicroorganismsusedinfoodproduction;•safetyofsubstancesproducedbymicroorganismsthatareusedasadditivesorprocessingaids,including3enzymesforuseinf

6、oodproduction;•specificpurportedhealthbenefitsorprobioticeffectsthatmaybeattributedtotheuseofmicroorganismsinfood;or•issuesrelatingtothesafetyoffoodproductionworkershandlingrecombinant-DNAmicroorganisms.3.Avarietyofmicroorganismsusedinfoodproductionh

7、avealonghistoryofsafeusethatpredatesscientificassessment.Fewmicroorganismshavebeenassessedscientificallyinamannerthatwouldfullycharacterizeallpotentialrisksassociatedwiththefoodtheyareusedtoproduce,including,insomeinstances,theconsumptionofviablemicr

8、oorganisms.Furthermore,theCodexprinciplesofriskanalysis,particularlythoseforriskassessment,areprimarilyintendedtoapplytodiscretechemicalentitiessuchasfoodadditivesandpesticideresidues,orspecificchemicalormicrobialcontaminantsthathaveidentifiablehazar