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TheconsolidationoffoodcontaminantsstandardsinChinaYiShao,JunWang,XiaoChen,YongningWuKeyLaboratoryofFoodSafetyRiskAssessment,MinistryofHealth,ChinaNationalCentreforFoodSafetyRiskAssessment,Beijing,ChinaNationalInstituteofNutritionandFoodSafety,ChineseCenterforDiseaseControlandPrevention,Beijing,ChinaarticleinfoArticlehistory:Received10December2013Receivedinrevisedform10March2014Accepted14March2014 Correspondingauthor.Tel.:860152165589;fax:860152165489.E-mailaddress:wuyongning@cfsa.net.cn(Y.Wu). ContentslistsavailableatFoodControljournalhomepage:www.elsevier.com/locate/foodcont http://dx.doi.org/10.1016/j.foodcont.2014.03.0170956-7135/2014ElsevierLtd.Allrightsreserved. FoodControl43(2014)213216 TherewereparticularsafetyconcernsinChina.FromMarch2010,surveydataontheactuallevelsofthesecontaminantsinfoodwerecollectedfromawiderangeofsources,includingChinafoodcontaminantsmonitoringsystemandtotaldietstudy.Thesedatawereusedtoestimatepotentialdietaryexposuretoeachcontaminant,whichtogetherwithextensivere-viewsofthetoxicologydata,wasusedtoassesstheriskassociatedwithexposuretoeachofthecontaminants.OneoutcomeoftheconsolidationisthatalltheregulatorylimitsforcontaminantsinfoodsarenowincludedintheGeneralStandardforContaminantsinFoods(GB2762-2012).3.PrinciplesandcriteriaforestablishingmaximumlevelsforcontaminantsinfoodsThegeneralprincipleinthecontrolofcontaminantsinfoodisthatthelevelsshouldbesafeandkeptaslowasreasonablyachievable(ALARA),withoutremovingthefoodfromthefoodsupply.TheALARAprincipleforcontaminantswasadoptedbytheCodexAlimentariusCommission(Codex,1996).Thisisbasedonthepremisethatcontaminantshavenointendedfunctioninfoodandtheirassociatedhealthriskmaynotyetbefullyunderstood.TheprinciplesforestablishingaMListhemagnitudeofthepotentialriskofpublichealthandsafety,aswellasthecapacityofalegallyenforceablestandardtoserveaneffectiveriskmanagementfunction.MLsshouldbesetatastrictlevelwhichisreasonablyachievablebyfollowinggoodagricultural,sheryandmanufacturingpracticesandtakingintoaccounttheriskrelatedtotheconsumptionofthefood(Codex,1995).Inmostcases,con-taminantsarefoundacrossanumberoffoods,andthereforethehealthriskmustbeassessedwiththetotaldietaryexposuretothecontaminant.MListhenestablishedifthereispotentialforadversehealtheffectsattheanticipatedlevelsoftotaldietaryexposure,orifthereispotentialforthelevelsofexposuretoincreasetounsafelevelsintheabsenceofothercontrols.ThismeansthatMLsarenotnecessaryforallkindsoffoods,andonlyforthoseinwhichthecontaminantmaybefoundinamountsthataresignicantforthetotalexposureofconsumer.Forexample,inChinariceconsump-tioncontributes50%tototaldietaryexposureofcadmium.There-fore,ifkeepcadmiumcontentinricelowenough,theriskofcadmiumexposurecouldbecontrolledwell.InChina,thecriteriaforselectingfoodcategoriesthatcontributecantlytototaldietaryexposureofacontaminantareasfollows:a)Foodsforwhichexposuretothecontaminantcontributesapproximately10%ormoreofthetolerableintake(e.g.PTDI,PTWI,orPTMI)inoneofthegeographicregion;or,b)Foodsforwhichexposuretothecontaminantcontributesapproximately5%ormoreofthetolerableintakeintwoormoreofthegeographicregion;or,c)Foodsthatmayhaveasignicantimpactonexposureforspe-cgroupsofconsumers,althoughexposuremaynotexceed5%ofthetolerableintakeinanygeographicregion.Thesewouldbeconsideredonacase-by-casebasis.Forsomecontaminantswithoutthetolerableintakevalue,thefoodcategoriesshouldbeselectedbyusingavailabledietaryintakedataandpotentialhealthrisks.Inthisconsolidation,ifwithoutsatisfactoryscienticdata,ChinawouldprefertoconsiderthefoodcategoriesthatCACorothercountrieshavesetMLs.Inmostcases,contaminationoccursintherawagriculturalproduceratherthaninprocessedfoods,andtherefore,MLsarenormallysetforrawagriculturalproductsonly(Peteretal.,2003Unlesstheprocessedfoodinvolveddehydrationorseparationoffoodcomponents,thelevelofcontaminantswouldnotincreaseordecreaseduringprocessing.MLsaresetforallprimarycommod-ities,whichprovid
e,ormaypotentiallyprovide,asignicontributiontothetotaldietaryexposuretothecontaminant.WherethesettingofaMLfortheprimarycommodityisjudgedtobeineffective,aMLmaybesetfornominatedprocessedfoods(e.g.,theMLforleadinpreservedegg).MLsforeachfoodcategoryaredeterminedbyanappropriaterisk-assessmentprocedureusingChinacontaminantmonitoringdataandfoodconsumptiondata.TheMLshouldalsobereasonablyachievablethroughsoundprimaryproductionandnaturalresourcemanagementpractices.AndaccordingtotheWorldTradeOrgani-sSanitaryandPhytosanitary(SPS)agreement,MLsofcon-taminantsshouldnotbesetatlevelslowerthaninternationalnormsunlessthereisaparticularidentiedpublichealthandsafetyconcernwithinChina,forexample,theMLsforcadmiuminrice.4.Outcomes4.1.ApplicationprinciplesForabetterinterpretationofthestandardduringapplication,thecriteriaforestablishingMLsanditsimplementationweredescribedintheGeneralStandardforContaminantsinFoods(GB2762-2012)astheapplicationprinciplesofthestandard.Thereareveapplicationprinciplesasfollowing:a)NomatterwhethertherearecontaminantsMLssetornot,foodbusinessoperatorsshouldtakemeasurestocontrolthelevelofcontaminantsinfoodaslowaspossible.b)MLsareonlysetforthecontaminantswhicharepotentialforadversehealtheffectsandonlyforthosefoodsinwhichthecontaminantmaybefoundinamountsthataresigniforthetotalexposureofconsumer.c)Thefoodcategorizationdescription(intheAnnexofthestan-dard)isusedtodenethescopeofMLsandonlyforthisstan-dard.WhenaMLappliedtoafoodcategory,thenthefoodunderthecategoryareallapplicable,exceptasotherwisespecid)Themaximumlevelshallbecalculatedfortheedibleportionofthefoodthatisordinarilyconsumed,exceptasotherwisee)WhenapplyingtheMLssetouttofoodstuffswhicharedried,changesoftheconcentrationofthecontaminantcausedbydryingshouldbetakenintoaccount.Thespecicconversionfactorsforthedryingshouldbedeterminedfromtheanalysisofthefood,theinformationprovidedbythefoodbusinessoperator,orgenerallyaccepteddata.4.2.InorganiccontaminantsTheMLsforlead,cadmium,arsenic,mercury,nickel,tin,chro-mium,nitrateandnitriteinavarietyoffoodcommoditiesareremainedinthenewgeneralstandard.MLswerediscontinuedforseleniumanduorineonthebasisthatthepotentialhealthriskstotheconsumerfromdietaryexposuretothesesubstancesarelow.Inviewofaluminuminourproductsmainlycausedbythe Table1Listofcontaminantsconsideredinthereform.uorine,aluminum,rare-earthmetals,lead,arsenic,mercury,cadmium,nickel,tin,chromium,nitrateandnitriteBenzo(a)pyrene,nitrosamine,polychlorinatedbiphenyls(PCBs),chloropropanolY.Shaoetal./FoodControl43(2014)213216214 intentionaluseofaluminum-containingfoodadditives,MLforaluminuminourproductsintheMaximumLevelsofContami-nantsinFoods(GB2762-2005)wasdiscontinued.Sincethehealthrisksofrare-earthmetalsstillneedtobefurtherassessed,theMListemporarilyretained,butnotincludedinthenewgeneralstandard,becausethesearenotcontaminants.Commoditiesthatcontributesubstantiallytothedietaryexpo-surefromtheseinorganiccontaminantsoveralifetimeofexposurewereidentiedbydietarymodelingtechniques,andMLswereestablishedbasedontheriskassessment.Forexample,theriskassessmentformercuryindicatesthatmercuryfromfruits,bever-agesandalcoholicdrinkstheonlycontributetolessthan5%ofprovisionaltolerableweeklyintakeofmercury.Therefore,thereisnotnecessarytosetMLsofmercuryforthosecommodities(asshowedinTable2).However,theprincipleisnotsuitableforlead.Atthe73rdmeetingofJECFA,thePTWIoflead(25g/kgbw)wasdrawnanditwasconcludedthatitwasnotpossibletoestablishanewPTWIthatwouldbeconsideredtobehealthprotective.TheJECFACommitteeconcludedthat,inpopulationswithprolongeddietaryexposurestoleadthatareatthehigherendoftherangesedabove,measuresshouldbetakentoidentifymajorcontributingsourcesandfoodsand,ifappropriate,toidentifymethodsofreducingdietaryexposurethatarecommensuratewiththelevelofriskreduction(JECFA,2011).CodexAlimentariushadalsoproposedtorevisetheMLsforleadinsomecommoditiestoreducetheexposureoflead(CodexCommitteeonContaminantsinFoods,2014
).AccordingtothestudyinChina(He,Wang,&Zhang,2009;Li,Liu,Liu,&Wu,2012),thedietaryexposureinChineseTotalDietStudyandthebloodleadlevelsofchildreninChinawerecantlyhigherthanthatindevelopedcountrieswhichshowsthatleadpollutiontotheenvironmentisstillserious.Therefore,althoughthecontributionofsomefoodcategoriestoleadexposurewaslow,inordertobettercontrolthedietaryexposureoflead,almostallthefoodthatpossiblycontributestothedietaryexposureofleadweresetMLsasshowedinTable34.3.OrganiccontaminantsFororganiccontaminants,MLsforbenzo(a)pyrene,nitrosamineinmeatproductsandaquaticproducts,polychlorinatedbiphenyls(PCBs)inaquaticanimalsandaquaticproducts,andchlor-opropanolsinliquidcondimentscontainingacid-hydrolyzedvegetableproteinareretained.NoMLshavebeenestablishedatthisstageforacrylamideordioxins,becauseofinsufcientdatatodeterminewhetherthereisarisktopublichealthatthecurrentlevelsofexposure.Ariskassessmentonthesecontaminantswillbeundertakenwhenmoredatabecomeavailable. Table2ListofMLsestablishedformercuryinthenewstandard.CommodityMaximumlevel(mg/kg)Aquaticanimalsandproducts(excludingshandproducts)0.5(methylmercury)shandproducts1.0(totalmercury)Rice,huskedrice,polishedrice,maize,maizemeal,wheat,wheat0.02(totalmercury)Vegetables0.01(totalmercury)Ediblefungiandediblefungiproduct0.1(totalmercury)Meatoflivestock0.05(totalmercury)Rawmilk,pasteurizedmilk,sterilizedmilk,fermentedmilk,modiedmilk0.01(totalmercury)Egg0.05(totalmercury)Salt0.1(totalmercury)Mineralwater0.001mg/L(totalmercury)Cannedcomplementaryfoodsforinfantsandyoungchildren0.02(totalmercury) Table3ListofMLsestablishedforleadinthenewstandard.CommodityMaximumlevel(mg/kg)Cerealsandcerealsproduct(excludingoatmeal,gluten,ricepuddingcans,stufngricenoodleproducts)Oatmeal,gluten,ricepuddingcans,stufngricenoodleproducts0.5Vegetables(excludingbrassicas,leafyvegetables,legumesandpotato)Brassicas,leafyvegetables0.3Legumesandpotato0.2Vegetableproducts1.0Fruit(excludingberriesandothersmallfruits)0.1Berriesandothersmallfruits0.2Fruitproduct1.0Ediblefungiandediblefungiproduct1.0Pulses0.2Pulseproducts(excludingsoybeanmilk)0.5Soybeanmilk0.05Algaeandalgaeproducts(excludingspirulinaandspirulinaproducts)1.0(dryNutsandseeds(excludingcoffeebeans)0.2Coffeebeans0.5Meatoflivestock0.2Ediblevisceraoflivestock0.5Meatproducts0.5Aquaticanimals(excludingsh,crustaceansandbivalves)1.0(excludingFishandcrustaceans0.5Bivalves1.5Aquaticproducts(excludingjellyshproducts)1.0shproducts2.0Rawmilk,pasteurizedmilk,sterilizedmilk,fermentedmilk,modiedmilkMilkpowders,non-demineralizedwheypowders0.5Othermilkproducts0.3Eggsandeggproducts(excludingpreservedeggs,sausageswithpreservedegg)Preservedeggs,sausageswithpreservedegg0.5Ediblefatsandoilsandtheirproducts0.1Condiment(excludingsalt,spices)1.0Salt2.0Spices3.0Sugarsandstarchsugars0.5Starches0.2Starchproducts0.5Bakeryproduct0.5Packageddrinkingwater0.01mg/LFruitjuices(excludingconcentratedfruitjuices)0.05mg/LConcentratedfruitjuices0.5mg/LProteinbeverages(excludingmilkbeverages)0.3mg/LMilkbeverages0.05mg/LCarbonateddrinks,teadrinks0.3mg/LSoliddrinks1.0Otherdrinks0.3mg/LAlcoholicbeverages(excludingdistilledliquorsandyellowricewine)Distilledliquorsandyellowricewine0.5Cocoaproducts,chocolateandchocolateproducts,candy0.5Frozendrinks0.3Infantandyoungchildrenformula0.15(powder0.02(readytouse)Cereal-basedcomplementaryfoodsforinfantsandyoungchildrenwithoutsh,liverorvegetableCereal-basedcomplementaryfoodsforinfantsandyoungchildrenwithsh,liverorvegetableCannedcomplementaryfoodsforinfantsandyoungchildrenwithoutaquaticorliverCannedcomplementaryfoodsforinfantsandyoungchildrenwithaquaticorliverJelly0.5Puffedfood0.5Tea5.0Drychrysanthemum5.0Broadleafhollyleaf2.0Honey1.0Pollen0.5Y.Shaoetal./FoodControl43(2014)213216215 4.4.ThefoodcategorysystemAfoodcategorysystemisneededfortheconsolidationpractice,inordertoensurethecompletecoverageofallfoodsandtheac-curacyofdietaryexposureestimate.ItwasnotedthattheGeneralSta
ndardforContaminantsandToxinsinFoodandFeed(CODEXSTAN193-1995)hadadoptedafoodcategorizationsystembasedCAC/MISC4ClassicationofFoodsandAnimalFeed.ToensureitsconsistencywiththeCodexclassicationsystemandalsoitsapplicabilitytotheChinafoodsupplyandregulatorysystem,anewfoodcategorysystemwasdevelopedforthecontaminantsstandard.TheGeneralStandardforContaminantsinFoods(GB2762-2012)incorporatedthefoodcategorysystemasitsAnnexfoodcategorizationdescriptionTable4).Thefoodcategorysys-temclassiedfoodsintogroupsand/orsub-groupsforthepurposeofestablishinggroupmaximumlimitsforcommoditieswithsimilarcontaminationcharacteristics,ratherthanitsmarketrep-resentation.Forexample,inChinapeanutbutterisinthecondi-mentcategory,butinthefoodcategorysystemofthenewstandard,itwasinthecategoryofnutsandseedsproduct.ThisensuresthatMLsforcontaminantsmayrepresentedinthestandardonthebasisofthedistributionruleofcontaminantsinfood.5.ConclusionsThenewtheGeneralStandardforContaminantsinFoods(GB2762-2012)waspromulgatedbytheMinistryofHealthonNovember2012andimplementedsinceJune2013.Thenewstandardcovers13contaminantsandmorethan20foodcategories.IncomparisonwiththecontaminantsMLsscatteredinvariescommoditystandardsinthepast,thenewstandardservesasasinglereferenceforallcontaminantsinallfoods,whichcouldbeusedeasilybyregulatoryagencies,industryandconsumers.Withtheexperienceintheconsolidationofstandardsforcon-taminantsinfoods,Chinahasrecentlylaunchedanambitiousprogrammetoconsolidatemorethan5000existingfoodstandardsintoonesinglemandatorynationalfoodsafetystandardsystem,whichisexpectedtocompletebytheendof2015.Bythattime,Chinawillformauniquesetofmandatorynationalfoodstandards,inwhichalmostallthecontaminantsMLswouldberegulatedintheGeneralStandardforContaminantsinFoods(GB2762-2012).Therefore,thestandardisveryimportantforthefoodsafetyriskmanagementinChina,andwillbeconstantlyrevisedandimprovedonthebasisoftheriskassessmentandtheeffectivenessofstandardimplementation.ReferencesCodex.(1995).CodexStandard193-1995thegeneralstandardforcontaminantsandtoxinsinfoodandfeed.CodexAlimentariusCommissionCodex.(1996).Codexriskassessmentandmanagementprocedures:MethodstoensurepublicsafetywhiledevelopingtheCodexGeneralStandardforcontaminantsandtoxinsinfood.CodexAlimentariusCommissionCX/FAC96/15Codex.(2013).CodexAlimentariusCommissionproceduralmanual(Twenty-rstedi-.TheSecretariatoftheJointFAO/WHOFoodStandardsProgramme,FAO,CodexCommitteeonContaminantsinFoods.(2014).Proposeddraftrevisionofthemaximumlevelsforleadinselectedcommoditiesinthegeneralstandardforcontaminantsandtoxinsinfoodandfeed(CODEXSTAN193-1995).CodexCom-mitteeonContaminantsinFoods,8thsession,CX/CF14/8/5JECFA.(2011).Evaluationofcertainfoodadditivesandcontaminants(Seventy-thirdreportoftheJointFAO/WHOExpertCommitteeonFoodAdditives).WHOTechnicalReportSeries,No.960He,K.,Wang,S.,&Zhang,J.(2009).BloodleadlevelsofchildrenanditstrendinScienceoftheTotalEnvironment,407(13),3986Li,X.,Liu,Q.,Liu,L,&Wu,Y.(2012).ApplicationofthedatafromChinaTotalDietStudytoassessthedistributionofleadexposureindifferentage-genderpop-ulationgroups.JournalofHygieneResearch,41(3),379Peter,A.,Janis,B.,Patricia,F.,Lynda,G.,Lisa,K.,Glenn,S.,etal.(2003).Reviewoftheregulationsforcontaminantsandnaturaltoxicants.FoodControl,14(6),383TheNationalPeoplesCongressofthePeoplesRepublicofChina.(2009).SafetyLawofthePeoplesRepublicofChina.The7thsessionofthe11thstandingcommitteeoftheNationalPeoplesCongressofthePeoplesRepublicofChina,February(pp.811)Wu,Y.,&Chen,Y.(2013).Editorial:foodsafetyinChina.JournalofEpidemiology&CommunityHealth,67,478479 Table4AnexamplethefoodcategorysystemdevelopedforGB2762-2012.FreshfruitFruitandfruitproductsBerriesandothersmallfruitsOtherfruits(includingsugarcane)FruitproductsCannedfruitsDriedfruitsPreservedfruitswithvinegar,oilorsaltJamandjellyCandiedfruits(includinghawrolls)FermentedfruitsCookedorfriedfruitsFruitdessertOtherfruitproductsY.Shaoetal./FoodControl43(2014)2132162