SafetyassessmentoffoodenzymeproducedwithGMM WenjingZhaiSafetyandRegulatoryAffairs,Novozymes2016-07-13,BeijingEnzymesolutions酶制Enzymesolutions酶制劑的解決方案無處不紡

食品和飲紙漿和造

生物

動物健康和營 農(nóng)皮 污水處CO2reductionsobtainedbyusingenzymesinvariousTextile/紡織品1100kgTextile/紡織品1100kgPertonoffabric/每噸織Animalfeed/動物飼料80kgPertonoffeed/每噸飼Detergent/洗滌劑100kg

PerkgenzymeCereals/谷物食Cereals/谷物食品110kgAgriculture/農(nóng)業(yè)15kgAgriculture/農(nóng)業(yè)15kgBeverage/飲料25kgPapermaking/造紙150kgPertonofpulp/Leather/皮革100kgPertonofhide/Cosmetics/化妝品190kgCosmetics/化妝品190kgPertonoffattyacidester/每噸脂Margarine/人造奶油23kgCO2Vegetableoil/植物油44kg230kg拉奶Pertonofmozzarella/每拉奶Regulatoryrequirementscanbedividedinto3OverallfoodNofurtherrestrictionsonenzymeusemeetgeneralfoodsafety Enzymetypeandproductionstrain肯定列表涵蓋Approvalofeachproductrequired基于4Safetyevaluationbasedonthenatureof基于活動類型的安全評估分 “Deliberate

“Contained 轉(zhuǎn)“GMfoodand轉(zhuǎn)Deliberateof指令轉(zhuǎn)“GMfoodand轉(zhuǎn)Deliberateof指令轉(zhuǎn)食labelingofGMOsandfoodandfeedproductsproducedfromGMOsDependingonthetypeofproductandactivitydifferentrulesapply按照產(chǎn)品類型和活動可能適用以下一個或若干 modifiedFoodand“Contained指令A(yù)tAtpresent,thereare59authorizedtypesofGMOsforfoodandfeedintheEU目前，歐盟共批準了5910cotton30maize4oilseedrape,12soybeans1sugarbeetand2microbialbiomassesforfeed10Onlyoneofthese(maizeMON810isauthorizedforcultivationintheEU其中只有一種被批準在歐盟種植（MON810玉米 modifiedFoodand GMOsforfoodand TheregulationsetstheprocedureforthescientificassessmentandauthorizationofGMOsandGMfoodandfeed.該 TheassessmentprocedurescoverboththeGMOitselfandthefoodandfeedderivatives評 TheEUriskassessmentfollowsinternationallyacceptedguidelinesdevelopedbyCodexAlimentarius(WHO/FAO歐盟的風(fēng)險評估遵循國際公認和食品 RiskassessmentiscarriedoutbytheEuropeanFoodSafetyAuthorityEFSA風(fēng)險評估由歐轉(zhuǎn)“GMfoodand轉(zhuǎn)“GMfoodandguidelines轉(zhuǎn)Deliberaterelease指令轉(zhuǎn)食labelingofGMOsandfoodandfeedproductsproducedfromGMOs Systemforassessingcase-by-casetheenvironmentalrisksassociatedwithreleasingGMOs ConcerningthetraceabilityandlabellingofGMOsandthetraceabilityoffoodandfeedproductsfromGMOs WhichproductsfallunderthescopeoftheGMFoodandFeedregulation(1829/2003)何種產(chǎn)品應(yīng)適用于轉(zhuǎn) Thetextofthelawsays

LeadingtotheconclusionFood*Food*andfeed*producedbyusingageneticallymodifiedmicro-organism(GMM)whichiskeptundercontainedconditionsandisnotpresentinthefinalproductarenotincludedinthescopethe利用轉(zhuǎn)微生物發(fā)酵生產(chǎn)的食品*和飼料*，本本飼料。區(qū)別在于來自轉(zhuǎn)的成分是否存在于食品或飼料ThisRegulationshouldcoverfoodandfeedproducedaGMObutnotfoodandfeed‘with’aGMO.Thedeterminingcriterioniswhetherornotmaterialderivedfromt modifiedsourcematerialispresentinthefoodorinthefeed.終產(chǎn)品，則不適用于1829/2003。這些食品和飼料應(yīng)被視作利用轉(zhuǎn)微生物生產(chǎn)的，而不是來自轉(zhuǎn)微生物的。微生物發(fā)酵生產(chǎn)的食品和飼料（ 2004年9月歐盟會

**includingfoodandfeedingredientssuchasLocalenvironmentalapprovalis需要當(dāng)?shù)氐腃oversanyactivityinvolvingGeneticallyModifiedMicroorganisms(GMMs)undercontainmenttolimitcontactoftheseorganismswiththeenvironment包含所有涉及在封閉條件下使用轉(zhuǎn) Suchactivitiesincludetheprocessofgeneticmodification,theuse,storage,transport,destructionanddisposalofGMmicroorganisms以上活 TheactivitiesareclassifiedinfourlevelswithassignedcontainmentCompaniesplanningtocommencesuchactivitiesmustnotifyitsnationalauthoritiesTheauthoritiesverifythattheinstallationisappropriatefortheactivityandthattheworkdoesnotposeanydangertohumanhealth(theworker)andtheenvironment預(yù)從事相關(guān)活動的公司必須向所在國主管機Aseticallymodifiedproducerorganismisunder‘containeduse’Aseticallymodifiedproducerorganismisunder‘containeduse’conditionsandnotracesoftheistobefoundinthefinal轉(zhuǎn) 轉(zhuǎn) TheTheenzymefeedorfoodproductisnotconsideredtobeaGMOproductanddoesnotneedapprovalundertheGMOrules Feedenzyme飼料 ProductapprovalProductapprovalisrequiredundertheEU1332/2008onfoodenzymes食品酶需要按照歐（1332/2008）進行批ProductapprovalisrequiredundertheEUFeedRegulation1831/2003飼料酶需要按照歐盟飼料添加（1831/2003）進行批或Safetyassessmentof酶制劑的以FIAP的數(shù)據(jù)要

一般批準程FIAPFoodImprovementAgentsPackage)食品改良劑3elementsinFIAPdossiersRiskassessmentbyGMdossierby 申報材料–RiskmanagementbyEU

Sand)FIAPDossier–RiskEnzymeCharacterizationandSpecifications酶的特征和標準ProductionMicroorganismManufacturingProcessPurposeandUseoftheEnzyme酶SafetyEvaluation安全數(shù)據(jù)和安全邊FIAPDossier–GMFIAP申報材料– 申報材料部

Category1:ChemicallydefinedpurifiedcompoundsandtheirmixturesinwhichbothGMMsandnewlyintroducedgeneshave Category2:ComplexproductsinwhichbothGMMsandnewlyintroducedgenesarenolongerpresent(e.g.cell Category3:ProductsderivedfromGMMsinwhichGMMscapableofmultiplicationoroftransferringgenesarenotpresent,butinwhichnewlyintroducedgenesarestillpresent(e.g.heat-inactivatedstartercultures);類別3：產(chǎn)品來生自轉(zhuǎn) Category4ProductsconsistingoforcontainingGMMscapableofmultiplicationoroftransferringgenes(e.glivestarterculturesfor 微intheproduct證明產(chǎn)品中不物Informationonthepossiblepresenceof的微intheproduct證明產(chǎn)品中不物Informationonthepossiblepresenceof的信Env.riskassessment環(huán)境風(fēng)險評估EnvironmentalexposureoftheGMMisnegligibleprovidedthatnoviableGMMsandbinantgenesoriginatingfromthemare Allergenicity致敏性（與已知過敏源（和素）的序列比較分析Nutritionalassessment(basicallyonlyfor類產(chǎn)品外數(shù)據(jù)Toxicology毒理學(xué)信息（天亞慢性Descriptionofproduct產(chǎn)品說明和使用方Composition產(chǎn)品的組Physicalproperties產(chǎn)品的物理特Inforelatingtoproductpreparation與最終產(chǎn)品有關(guān)的信息DemonstrationoftheabsenceoftheInforelatingtoproductionprocess與生DetaileddescriptionofproductionInforelatingtoGMM(stability,identificationanddetectiontechniques,etc) eticDescriptionof述Characteristicsoftherecipientorparentalmicroorganism(taxonomy,geneticstability,historyCharacteristicsoftheoriginoftheinsertedsequences(donororganism(s)) Daterequiredforeach對各類 微生物及其產(chǎn)品的數(shù)據(jù)要Category類別Category類別不Category類別Category類別III.Microorganism受體或親本生物體的特1.Scientificname,taxonomyandothernamesXXXXIII.2PhenotypicandgeneticmarkersXXXXIII.3.DegreeofrelatednessbetweenrecipientIII.4.DescriptionofidentificationandXXIII. XIII.6.OrganismswithwhichtransferofXXIII.materialisknowntooccurunderconditionsandpresenceofindigenousmobileelementsDaterequiredforeach對各類 微生物及其產(chǎn)品的數(shù)據(jù)要Category類別

Category類別

Category類別

Category類別

Informationon eticstabilityofrecipientmicroorganism關(guān)于受體微生物遺傳穩(wěn)定性的

III.Pathogenicity,ecologicaland III.Descriptionofitshistoryofuse使用記錄說 III.Historyofpreviousgeneticmodifications之前的 III.Characteristicsoftheoriginofthe III.sequences(donor 序 的特（供體微生物1DNAfromdefineddonororganisms從規(guī)定的供體生XXXXIII.2SyntheticDNA合成XXXXIII.3.NucleicacidsdirectlyextractedfromXXXXIII. 描III.1CharacteristicsofthevectorXXXXIII.2.Informationrelatingtoteticmodification與XXXXIII.Daterequiredforeach對各類 微生物及其產(chǎn)品的數(shù)據(jù)要Category類別Category類別Category類別Category類別InformationrelatingtotheGMMandcomparisonoftheGMMwithanIII.Comparator與GMM及其適宜對比物的1.Descriptionofgenetictrait(s)orphenotypiccharacteristicsand,inparticular,anynewXXXXIII.andcharacteristicswhiaybeexpressedornolongerexpressed遺傳性狀或表型特征，以2Structureandamountofanyvectorand/ordonornucleicacidremainingintheGMMXXXXIII.3.StabilityoftetictraitsintheGMM轉(zhuǎn)微生物中的遺傳性狀穩(wěn)定XXXIII.4.RateandlevelofexpressionofthenewgeneticmaterialandactivityoftheexpressedXXIII.5DescriptionofidentificationanddetectiontechniquesXXXXIII.6.Informationontheabilitytotransfergeneticmaterialtootherorganisms有關(guān)能夠?qū)⑽镔|(zhì)XXIII.7.HistoryofprevioususesorenvironmentalreleasesoftheGMM,whenappropriateXXIII.8SafetyforhumansandanimalsXXXDaterequiredforeach對各類 微生物及其產(chǎn)品的數(shù)據(jù)要Category類別Category類別Category類別Category類別章、Informationrelatingtotheproductionprocess與生XXXXIII.InformationrelatingtotheproductIII.process與產(chǎn)品程序相關(guān)的信1.DemonstrationoftheabsenceoftheGMMinXXXIII.2.InformationontheinactivationoftheGMMcellsXXIII.evaluationofthepresenceofremaining3.Informationonthepossiblepresence XXXIII.Descriptionoftheproduct產(chǎn)品說明III.1DesignationoftheproductXXXIII.2.IntendeduseandmodeofactionXXXIII.式3CompositionXXXIII.4PhysicalpropertiesXXXIII.Daterequiredforeach對各類 微生物及其產(chǎn)品的