快速消费品-食品-饮料-化妆品-研发工作

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MaturitasInthepasttwodecades,therehasbeenanexponentialincreaseintheuseofmedicinalherbalproductsaroundtheworld.Invariouscountries,theseproductsareclassifiedandpromotedasfoods,notpharmaceuticals,whichfacilitatetheiravailabilityontheinternationalmarketwithoutrequiringamedicalprescription.Sinceolderadults(OAs)areanimportantandgrowingsectorofthepopulationinmanycountries,itisimportanttoknowtheprevalenceoftheirherbalproductuse,sincemanyOAtakeherbsalongwithdiversequantitiesofprescriptionandoverthecountermedications.Forthisreason,itisimportanttobeawareofthepossibilitiesofhealthcomplicationsduetotheconcomitantuseofdiversemedicationsandherbs.OAareanespeciallyvulnerablepopulation,sincemanyofthehumanbody'sphysiologicalactivities,suchasrenalandhepaticdetoxificationandclearanceusuallydecreasewithage.Additionally,informationoncertainherbalproductsiseithermisleading,orsimplyunavailable.Theseproductsmayindeedbeatherapeuticoption,butsomecanbeusedproperlyonlyundertheguidanceofahealthprofessional.ThoseOAtakingcombinationsofvariousmedicationsandherbalsupplementsarealsomoreatrisktoexperiencesomesortofherb–druginteractions.ThispublicationreviewsselectedarticlesrelatedtotheuseofherbalproductsbyOAsandmentionsthevariouspatternsofuseandhealthimplicationsoftheconcomitantuseofherbalproductsandprescriptionmedications.Thistopiciscurrentlynotfullyunderstoodandfurtherresearchiswarranted.ArticleOutline..9.

FoodPolicyCanadianregulationshavedifferentrulesforfoodsandnaturalhealthproducts(NHPs)regardingallowablehealthclaims,requirementsforuseinclinicaltrialsandgoodmanufacturingstandardsandlabelingrequirements.Howtheserulesapplytoproductsatthefood–NHPinterfaceisoftenunclear.Thispaperdescribestheregulatoryenvironmentandexplorestwoproductexamples–probioticyogurtandgreentea–toillustratetheissue.Inaddition,resultsfromaqualitativestudyofNHP/foodresearchershighlightstheconfusionandfrustrationofthoseworkinginthefield.InterimagreementsbetweentheNHPandFoodsDirectorateofHealthCanadaregardingproductsreviewsprovideatemporaryresponsebutregulatoryamendments,accompaniedbyclearguidancetostakeholders,areneeded.ArticleOutline

JournalofAdolescentHealthPurposeTodescribetheprevalenceofherbalproductuseinadolescentsandtheassociationbetweenherbalproductuseandtobacco,alcohol,andotherdruguse.MethodsThe1999MonroeCounty,NewYorkYouthRiskBehaviorSurveyprovideddataonarandomsampleof2,006highschoolstudents.Herbalproductusewasdefinedbylifetimeuseof“herbalorothernaturalproducts—tofeelbetter,orperformbetterinsportsorschool.”Bivariateanalysesusingχ2testsandlogisticregressionswereusedtodescribetheindependentassociationsbetweenResultsOverall,28.6%reportedusingherbalproducts.Herbalproductuseincreasedwithage(24.5%of9thgradersto29.9%of12thgraders;p<.04)andvariedbyethnicity(33%ofHispanics,30.9%ofCaucasians,28.8%ofAsians,NativeAmericans,orPacificIslanders,and12.1%ofAfricanAmericans;p<.001),butnotbygender.Aftercontrollingforgender,grade,andethnicity,logisticregressionmodelsshowedherbalproductusetobeassociatedwithlifetimeuseof:cigarettes(OR=2.2;95%CI=1.8–2.8),alcohol(OR=3.5;2.5–4.9),marijuana(OR=2.2;1.8–2.7),andotherdrugs(oddsratiosfrom4.4to14.5).Allpvalueswere<.001.ConclusionsOverone-quarterofhighschoolstudentsreportherbalproductuse,andthisuseisassociatedwithdruguse.Healthcareprovidersshouldinquireaboutadolescents’herbalproductuse,anddisclosureshouldpromptanin-depthsubstanceusehistory.ArticleOutline

JournalofEthnopharmacologyGraphicalabstractExtractsof21plantspeciesusedtomakeImbizaephuzwato,aZuluherbalmixturewereeachinvestigatedfortheirpharmacologicalproperties.Severalplantspeciesdemonstratedgoodactivitieswhich,ifsupportedbyotherconfirmatorytests,justifytheirinclusioninthemakeupofImbizaephuzwatoherbalmixtureaswellastheiruseintraditionalmedicine.

JournalofAllergyandClinicalImmunology

Graphicalabstract10,455articlesfoundfor:pub-date>2003andtak(((HealthfoodR&Dprojects)or(Cooperationprojectsinresearchinstitutions)or(Herbalhealthproducts)or(AppliedResearchandEvaluation)or(Smalltest)ortestor(trialproduction))and((IndustrySeminar)or(Managementandintelligence)orMedicineordrugsor(AnalyticalChemistry)or(FoodSpecialty)))18articlesfoundfor:pub-date>1999andtak(((HealthfoodR&Dprojects)or(Cooperationprojectsinresearchinstitutions)or(Herbalhealthproducts)or(AppliedResearchandEvaluation))and((Smalltest)ortestor(trialproduction))and((IndustrySeminar)or(Managementandintelligence)orMedicineordrugsor(AnalyticalChemistry)or(FoodSpecialty)))

FoodandChemicalToxicologyInthisreportthevariouselementsofthesafetyandnutritionalassessmentprocedureforgeneticallymodified(GM)plantderivedfoodandfeedarediscussed,inparticularthepotentialandlimitationsofanimalfeedingtrialsforthesafetyandnutritionaltestingofwholeGMfoodandfeed.ThegeneralprinciplesfortheriskassessmentofGMplantsandderivedfoodandfeedarefollowed,asdescribedintheEFSAguidancedocumentoftheEFSAScientificPanelonGeneticallyModifiedOrganisms.InSection1themandate,scopeandgeneralprinciplesforriskassessmentofGMplantderivedfoodandfeedarediscussed.ProductsunderconsiderationarefoodandfeedderivedfromGMplants,suchasmaize,soybeans,oilseedrapeandcotton,modifiedthroughtheintroductionofoneormoregenescodingforagronomicinputtraitslikeherbicidetoleranceand/orinsectresistance.FurthermoreGMplantderivedfoodandfeed,whichhavebeenobtainedthroughextensivegeneticmodificationstargetedatspecificalterationsofmetabolicpathwaysleadingtoimprovednutritionaland/orhealthcharacteristics,suchasricecontainingβ-carotene,soybeanswithenhancedoleicacidcontent,ortomatowithincreasedconcentrationofflavonoids,areconsidered.ThesafetyassessmentofGMplantsandderivedfoodandfeedfollowsacomparativeapproach,i.e.thefoodandfeedarecomparedwiththeirnon-GMcounterpartsinordertoidentifyintendedandunintended(unexpected)differenceswhichsubsequentlyareassessedwithrespecttotheirpotentialimpactontheenvironment,safetyforhumansandanimals,andnutritionalquality.Keyelementsoftheassessmentprocedurearethemolecular,compositional,phenotypicandagronomicanalysisinordertoidentifysimilaritiesanddifferencesbetweentheGMplantanditsnearisogeniccounterpart.Thesafetyassessmentisfocussedon(i)thepresenceandcharacteristicsofnewlyexpressedproteinsandothernewconstituentsandpossiblechangesinthelevelofnaturalconstituentsbeyondnormalvariation,andonthecharacteristicsoftheGMfoodandfeed,and(ii)thepossibleoccurrenceofunintended(unexpected)effectsinGMplantsduetogeneticmodification.InordertoidentifytheseeffectsacomparativephenotypicandmolecularanalysisoftheGMplantanditsnearisogeniccounterpartiscarriedout,inparallelwithatargetedanalysisofsinglespecificcompounds,whichrepresentimportantmetabolicpathwaysintheplantlikemacroandmicronutrients,knownanti-nutrientsandtoxins.Significantdifferencesmaybeindicativeoftheoccurrenceofunintendedeffects,whichrequirefurtherinvestigation.Section2providesanoverviewofstudiesperformedforthesafetyandnutritionalassessmentofwholefoodandfeed.Extensiveexperiencehasbeenbuiltupinrecentdecadesfromthesafetyandnutritionaltestinginanimalsofirradiatedfoods,novelfoodsandfruitandvegetables.TheseapproachesarealsorelevantforthesafetyandnutritionaltestingofwholeGMfoodandfeed.ManyfeedingtrialshavebeenreportedinwhichGMfoodslikemaize,potatoes,rice,soybeansandtomatoeshavebeenfedtoratsormiceforprolongedperiods,andparameterssuchasbodyweight,feedconsumption,bloodchemistry,organweights,histopathologyetchavebeenmeasured.ThefoodandfeedunderinvestigationwerederivedfromGMplantswithimprovedagronomiccharacteristicslikeherbicidetoleranceand/orinsectresistance.Themajorityoftheseexperimentsdidnotindicateclinicaleffectsorhistopathologicalabnormalitiesinorgansortissuesofexposedanimals.Insomecasesadverseeffectswerenoted,whichweredifficulttointerpretduetoshortcomingsinthestudies.ManystudieshavealsobeencarriedoutwithfeedderivedfromGMplantswithagronomicinputtraitsintargetanimalspeciestoassessthenutritivevalueofthefeedandtheirperformancepotential.Studiesinsheep,pigs,broilers,lactatingdairycows,andfish,comparingtheinvivobioavailabilityofnutrientsfromarangeofGMplantswiththeirnearisogeniccounterpartandcommercialvarieties,showedthattheywerecomparablewiththosefornearisogenicnon-GMlinesandcommercialvarieties.InSection3toxicologicalinvivo,insilico,andinvitrotestmethodsarediscussedwhichmaybeappliedforthesafetyandnutritionalassessmentofspecificcompoundspresentinfoodandfeedorofwholefoodandfeedderivedfromGMplants.Moreoverthepurpose,potentialandlimitationsofthe90-dayrodentfeedingtrialforthesafetyandnutritionaltestingofwholefoodandfeedhavebeenexamined.Methodsforsingleandrepeateddosetoxicitytesting,reproductiveanddevelopmentaltoxicitytestingandimmunotoxicitytesting,asdescribedinOECDguidelinetestsforsinglewell-definedchemicalsarediscussedandconsideredtobeadequateforthesafetytestingofsinglesubstancesincludingnewproductsinGMfoodandfeed.VariousinsilicoandinvitromethodsmaycontributetothesafetyassessmentofGMplantderivedfoodandfeedandcomponentsthereof,like(i)insilicosearchesforsequencehomologyand/orstructuralsimilarityofnovelproteinsortheirdegradationproductstoknowntoxicorallergenicproteins,(ii)simulatedgastricandintestinalfluidsinordertostudythedigestivestabilityofnewlyexpressedproteinsandinvitrosystemsforanalysisofthestabilityofthenovelproteinunderheatorotherprocessingconditions,and(iii)invitrogenotoxicitytestmethodsthatscreenforpointmutations,chromosomalaberrationsandDNAdamage/repair.Thecurrentperformanceofthesafetyassessmentofwholefoodsismainlybasedontheprotocolsforlow-molecular-weightchemicalssuchaspharmaceuticals,industrialchemicals,pesticides,foodadditivesandcontaminants.Howeverwithoutadaptation,theseprotocolshavelimitationsfortestingofwholefoodandfeed.Thisprimarilyresultsfromthefactthatdefinedsinglesubstancescanbedosedtolaboratoryanimalsatverylargemultiplesoftheexpectedhumanexposure,thusgivingalargemarginofsafety.Incontrastfoodstuffsarebulky,leadtosatiationandcanonlybeincludedinthedietatmuchlowermultiplesofexpectedhumanintakes.Whentestingwholefoods,thepossiblehighestconcentrationoftheGMfoodandfeedinthelaboratoryanimaldietmaybelimitedbecauseofnutritionalimbalanceofthediet,orbythepresenceofcompoundswithaknowntoxicologicalprofile.Theaimofthe90-daysrodentfeedingstudywiththewholeGMfoodandfeedistoassesspotentialunintendedeffectsoftoxicologicaland/ornutritionalrelevanceandtoestablishwhethertheGMfoodandfeedisassafeandnutritiousasitstraditionalcomparatorratherthandeterminingqualitativeandquantitativeintrinsictoxicityofdefinedfoodconstituents.ThedesignofthestudyshouldbeadaptedfromtheOECD90-dayrodenttoxicitystudy.Theprecisestudydesignhastotakeintoaccountthenatureofthefoodandfeedandthecharacteristicsofthenewtrait(s)andtheirintendedroleintheGMfoodandfeed.A90-dayanimalfeedingtrialhasalargecapacity(sensitivityandspecificity)todetectpotentialtoxicologicaleffectsofsinglewelldefinedcompounds.Thiscanbeconcludedfromdatareportedonthetoxicologyofawiderangeofindustrialchemicals,pharmaceuticals,foodsubstances,environmental,andagriculturalchemicals.Itispossibletomodelthesensitivityoftheratsubchronicfeedingstudyforthedetectionofhypotheticallyincreasedamountofcompoundssuchasanti-nutrients,toxicantsorsecondarymetabolites.WithrespecttothedetectionofpotentialunintendedeffectsinwholeGMfoodandfeed,itisunlikelythatsubstancespresentinsmallamountsandwithalowtoxicpotentialwillresultinanyobservable(unintended)effectsina90-dayrodentfeedingstudy,astheywouldbebelowtheno-observed-effect-levelandthusofunlikelyimpacttohumanhealthatnormalintakelevels.Laboratoryanimalfeedingstudiesof90-daysdurationappeartobesufficienttopickupadverseeffectsofdiversecompoundsthatwouldalsogiveadverseeffectsafterchronicexposure.Thisconclusionisbasedonliteraturedatafromstudiesinvestigatingwhethertoxicologicaleffectsareadequatelyidentifiedin3-monthsubchronicstudiesinrodents,bycomparingfindingsat3and24monthsforarangeofdifferentchemicals.The90-dayrodentfeedingstudyisnotdesignedtodetecteffectsonreproductionordevelopmentotherthaneffectsonadultreproductiveorganweightsandhistopathology.Analysesofavailabledataindicatethat,forawiderangeofsubstances,reproductiveanddevelopmentaleffectsarenotpotentiallymoresensitiveendpointsthanthoseexaminedinsubchronictoxicitytests.Shouldtherebestructuralalertsforreproductive/developmentaleffectsorotherindicationsfromdataavailableonaGMfoodandfeed,thenthesetestsshouldbeconsidered.Byrelatingtheestimateddailyintake,ortheoreticalmaximumdailyintakepercapitaforagivenwholefood(orthesumofitsindividualcommercialconstituents)tothatconsumedonaverageperratperdayinthesubchronic90-dayfeedingstudy,itispossibletoestablishthemarginofexposure(safetymargin)forconsumers.ResultsobtainedfromtestingGMfoodandfeedinrodentsindicatethatlarge(atleast100-fold)‘safety’marginsexistbetweenanimalexposurelevelswithoutobservedadverseeffectsandestimatedhumandailyintake.ResultsoffeedingstudieswithfeedderivedfromGMplantswithimprovedagronomicproperties,carriedoutinawiderangeoflivestockspecies,arediscussed.Thestudiesdidnotshowanybiologicallyrelevantdifferencesintheparameterstestedbetweencontrolandtestanimals.ThestudieshaveshownthattargetedcompositionalanalysisisthecornerstoneforthesafetyassessmentofGMplantsmodifiedforagronomicinputtraits,andoncecompositionalequivalencehasbeenestablished,feedingstudieswithlivestockspeciesaddlittletotheirsafetyassessment.ExamplesofmodelsforlivestockfeedingstudieswithGMplantswithincreasedconcentrationofdesirablenutrientsareprovided.Suchstudiesshouldbeconductedonacase-by-casebasistoestablishthenutritionalbenefits.Possibleeffectsofthenewfeedresourceonanimalperformance,animalhealth,efficacy,andacceptabilityofthenewfeedingredientshouldbeinvestigated,andtimespansforsuchstudiesshouldbedeterminedonacase-by-casebasis.ThefeasibilityandlimitationsofhumanstudieswithfoodsderivedfromGMplantsarediscussed,aswellasthepotentialandlimitationsofpost-marketmonitoringtodetectunintendedeffectsofthesefoods.Post-marketmonitoringisnotasubstituteforathoroughpre-marketriskassessment.InSection4standardsfortestsamplepreparation,testmaterials,dietformulationandanalysisareevaluated.Specificattentionispaidtothechoiceofcontroldietsandcomparators,dietarystability,andnutritionalbalancingofdiets.Whentestingwholefoods,itisdesirabletoobtainthehighestconcentrationpossibleoftheGMfoodandfeedinthelaboratoryanimaldietwithoutcausingnutritionalimbalance.Normalpracticeistouseaminimumoftwotestdoselevelsandnegativecontrolwithwhichtocreatenutritionallyequivalentbalanceddietsinacomparativeprotocol.ItisrecommendedtoincludearelevantnumberofcommercialvarietiesascontroldietstodemonstratethebiologicalrangeoftheparameterswhicharemeasuredinordertoassessthebiologicalrelevanceofstatisticallysignificantdifferencesbetweentheGMplantanditscounterpart.ThechoiceofthecomparatorforGMfoodandfeedtestingiscrucial,andcanbefoundintheparental(nearisogenic)line.Formodifiedmacronutrientsacomparatoristheunmodifiedformofthemacronutrient.ForinvestigatingGMfoodandfeedwithenhancednutritionalproperties,choicesforcontroldietsshouldbemadeonacase-by-casebasis.Section5providesinformationonthecollection,analysisandinterpretationofdataandfindingsobtainedfromanimalfeedingstudies.DatagenerationforthepredictionofsafetyandnutritionalvalueofGMplantderivedfoodandfeedmustbeofhighqualityinordertoperformaproperhazardidentificationandriskassessment.ThisshouldbebasedontheuseofstandardisedstudydesignsconductedtotheprinciplesofGoodLaboratoryPractise,incorporatingrandomqualityassuranceauditsofallphasesofthestudy.Expertdataevaluationandanalysisarecriticalforestablishinganyassociationbetweenexposureandoutcome.Thisinvolvesspecialistsfromabroadrangeofscientificdisciplinessuchastoxicologists,haematologists,clinicalbiochemists,pathologists,humanandanimalnutritionistsandalsobiostatisticians.Oneofthepivotalrequirementsindataanalysisistodistinguishthoseeffectswhicharepotentiallytreatmentrelatedfromspuriousoccurrencesortheresultofnormalindividualbiologicalvariation.Ifdifferencesexistbetweentestandcontrol,comparisontohistoricalcontroldatafromthesamelaboratoryaswellaspublisheddataforthestrain,sexandageoftheanimalbeinginvestigatedishelpful,aswellasdataobtainedwithcommercialreferencelines.InSection6strategiesareoutlinedforthesafetyandnutritionalassessmentofGMplantderivedfoodandfeed.Thegenerationofstudiesforpre-marketassessmentofthesafetyandnutritionalpropertiesoffoodandfeedfromGMplantsshouldfollowastructuredapproachwithstepwisedevelopmentandconsiderationofthedataobtainedateachstepinordertoformulatethequestionstobeaskedandansweredatthenextstep(seeFig.3).Hazardsrelatedtotheintendedgeneticmodificationsareevaluatedapplyinginsilico,invitroandinvivosafetystudiesofnewlyexpressedprotein(s),newlyformedmetabolites,andofnaturalsubstanceswhoselevelsmayhavebeenalteredasaresultofgeneinsertion.GuidelineshavebeendevelopedbyOECDdescribingdetailedprotocolsforthesafetytestingofthesesubstancesinfoodandfeed.Adetailedtestingstrategyshouldbedesignedbasedonthepriorknowledgeregardingthebiologyoftheseproducts,sothattherelevantendpointsaremeasuredintheindividualtest.TestingofthesafetyandnutritionalvalueofthewholeGMplantorderivedfoodandfeedshouldbeconsideredwherethemolecular,compositional,phenotypic,agronomicandotheranalyseshavedemonstrateddifferencesbetweentheGMplantderivedfoodandfeedandtheirconventionalcounterpart,apartfromtheinsertedtrait(s),orifthereareanyindicationsorremaininguncertaintiesforthepotentialoccurrenceofunintendedeffects.Insuchacase,thetestingprogramshouldincludeatleasta90-dayrodentfeedingstudy.InthecontextofthesafetyandnutritionalassessmentofGMplantderivedfoodandfeed,theadapted90-dayrodentfeedingstudy,iftriggeredbytheoutcomeofthemolecular,compositional,phenotypicoragronomicanalysis,functionsasasentinelstudydesignedtoassesspotentialunintendedeffectsoftoxicologicaland/ornutritionalrelevanceratherthandeterminingqualitativeandquantitativeintrinsictoxicityofdefinedfoodconstituents.Inthesituationwheremolecular,compositional,phenotypic,agronomicandotheranalyseshavedemonstratedequivalencebetweentheGMplantderivedfoodandfeedandtheirnearisogeniccounterpart,exceptfortheinsertedtrait(s),anddonotindicatetheoccurrenceofunintendedeffects,experienceswithGMplantsmodifiedforagronomicinputtraitshavedemonstratedthattheperformanceof90-dayfeedingtrialswithrodentsorfeedingtrialswithtargetanimalspecieshaveprovidedlittleifanythingtotheoverallsafetyassessment(exceptforaddedconfirmationofsafety).Theuseof90-daysstudiesinrodentsshouldbeconsideredforthedetectionofpossibleunintendedeffectsinfoodandfeedderivedfromGMplantswhichhavebeenmoreextensivelymodifiedinordertocopewithenvironmentalstressconditionslikedroughtorhighsaltconditions,orGMplantswithqualityoroutputtraitswiththepurposetoimprovehumanoranimalnutritionand/orhealth.Ninety-daystudieswithrodentsarenormallyofsufficientdurationfortheidentificationofgeneraltoxicologicaleffectsofcompoundsthatwouldalsogiveadverseeffectsafterchronicexposure.Ingeneral,longterm,chronictoxicitytestingofwholeGMfoodandfeedisnotexpectedtogenerateinformationadditionaltowhatisalreadyknownfrominsilico/invitrotestingandfromsubchronictesting.IncaseswherestructuralalertsorotherinformationisavailableaboutthepossiblyalteredoccurrenceoffoodcomponentsintheGMfoodandfeedcomparedtoitscounterpart,theperformanceofspecifictoxicologicaltesting,e.g.chronic,reproductive,etc.,shouldbeconsideredcase-by-case,butpreferentiallyonlyforthesinglesubstanceofconcern.Livestockfeedingstudieswithtargetanimalspeciesshouldbeconductedonacase-by-casebasistoestablishthenutritionalbenefitsthatmightbeexpectedfromGMplantswithclaimednutritional/healthbenefits.Possibleeffectsofthenewfeedresourceonanimalperformance,animalhealth,efficacy,andacceptabilityofthenewfeedingredientshouldbeinvestigated,andtimespansforsuchstudiesshouldbedeterminedonacase-by-casebasis.Thereisaneedforamoreuniformapproachtothedesignandanalysisofanimalfeedingtrials,andinparticularforappropriatestatisticalanalysisofdata.Theprocessofdatainterpretationrequiresextensiveprofessionalexperienceofthefield,togetherwithathoroughunderstandingoftheconceptofcausality.Oneofthepivotalrequirementsistodistinguishthoseeffectswhicharepotentiallytreatmentrelatedfromspuriousoccurrencesorresultfromnormalindividualbiologicalvariation.Post-marketmonitoringisnotasubstituteforathoroughpre-marketriskassessment,neithershoulditbeconsideredasaroutineneed.Knowledgegainedthroughpost-marketmonitoringmightatbestdescribeonlybroadpatternsofhumannutritionalexposure.IngeneralitcannotberelieduponasatechniqueformonitoringadverseeventsorotherhealthoutcomesrelatedtotheconsumptionofGMplantderivedfoodandfeed.Itcanbeanticipatedthatinthefuturethepredictivevalueofa90-dayrodentfeedingstudiesusedforthesafetyassessmentofwholefoodandfeedwillbeenhancedbytheintegrationofnewtechnologiesliketranscriptomics,proteomicsandmetabolomicsintotheexperimentalriskassessmentapproach.Moreover,theuseof‘profiling’technologiesmayalsofacilitateanon-targetedapproachincompositionalanalysisinordertoaidthedetectionofunintendedeffectsinGMplantderivedfoodandfeedduetothegeneticmodification.Thesetechnologiesarestillunderdevelopment,andneedvalidationbeforetheycanbeusedforroutinesafetyassessmentpurposes.InSection7conclusionsandrecommendationsarepresentedon:•ThecomparativeapproachtosafetyandnutritionaltestingoffoodandfeedderivedfromGMplants.•InsilicoandinvitrotoolsavailableforsafetyandnutritionaltestingofGMplantderivedfoodandfeed.•TestingofdefinedsinglesubstancesfromGMplantderivedfoodandfeedininvivostudies.•TestingofwholeGMplantderivedfoodandfeedinanimalfeedingstudies.•Importanceofastructuredapproachfordevelopmentofdataforthepre-marketsafetyandnutritionaltestingofGMplantderivedfoodandfeed.•Roleofpost-marketmonitoring.ArticleOutline....................................................................................................

GacetaSanitariaIntroductionAdvancesingenomicanalysistechnologieshaveledtothedevelopmentofnewdiagnostictestswithclinicalapplication.Therefore,asinotherdiagnosticfields,awarenessofthemethodologicallimitationsofgeneticinvestigationwillfacilitatetheapplicationoftheresults.Methods44articleswhichstudiedthediagnosticaccuracyofgenetic,molecularandproteomictests,andpublishedinJAMA,Lancet,NewEnglandJournalofMedicine,CancerResearchyClinicalCancerResearchfrom2002toJune2005wereanalysed.24methodologicalcriteriaoftheSTARDguide(StandardsforReportingofDiagnosticAccuracy)wereapplied.Results