食品和飼料中污染物和毒素標準

GENERALSTANDARDFORCONTAMINANTSANDTOXINSINFOODANDFEEDCXS193-1995

Adoptedin1995

Revisedin1997,2006,2008,2009

Amendedin2010,2012,2013,2014,2015,2016,2017,2018,2019

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1.1SCOPE

ThisStandardcontainsthemainprincipleswhicharerecommendedbytheCodexAlimentariusindealingwithcontaminantsandtoxinsinfoodandfeedandliststhemaximumlevelsandassociatedsamplingplansofcontaminantsandnaturaltoxicantsinfoodandfeedwhicharerecommendedbytheCodexAlimentariusCommission(CAC)tobeappliedtocommoditiesmovingininternationaltrade.

ThisStandardincludesonlymaximumlevelsofcontaminantsandnaturaltoxicantsinfeedincaseswherethecontaminantinfeedcanbetransferredtofoodofanimaloriginandcanberelevantforpublichealth.

1.2DEFINITIONOFTERMS

1.2.1General

ThedefinitionsforthepurposeoftheCodexAlimentarius,asmentionedintheProceduralManualoftheCodexAlimentariusCommission,areapplicabletotheGeneralStandardforContaminantsandToxinsinFoodandFeed(GSCTFF)andonlythemostimportantonesarerepeatedhere.Somenewdefinitionsareintroduced,wherethisseemswarrantedtoobtainoptimalclarity.Whenreferenceismadetofoods,thisalsoappliestoanimalfeed,inthosecaseswherethisisappropriate.

1.2.2Contaminant

CodexAlimentariusdefinesacontaminantasfollows:

“Anysubstancenotintentionallyaddedtofoodorfeedforfoodproducinganimals,whichispresentinsuchfoodorfeedasaresultoftheproduction(includingoperationscarriedoutincrophusbandry,animalhusbandryandveterinarymedicine),manufacture,processing,preparation,treatment,packing,packaging,transportorholdingofsuchfoodorfeed,orasaresultofenvironmentalcontamination.Thetermdoesnotincludeinsectfragments,rodenthairsandotherextraneousmatter”.

ThisStandardappliestoanysubstancethatmeetsthetermsoftheCodexdefinitionforacontaminant,includingcontaminantsinfeedforfood-producinganimals,except:

1)Contaminantshavingonlyfoodandfeedqualitysignificance(e.g.copper),butnopublichealthsignificance,inthefood(s)giventhatthestandardselaboratedwithintheCommitteeonContaminantsinFoods(CCCF)hastheobjectivetoprotectpublichealth.

2)Pesticideresidues,asdefinedbytheCodexdefinitionthatarewithinthetermsofreferenceoftheCommitteeonPesticideResidues(CCPR).

3)Residuesofveterinarydrugs,asdefinedbytheCodexdefinition,andresiduesoffeedadditives(*),thatarewithinthetermsofreferenceoftheCommitteeonResiduesofVeterinaryDrugsinFoods(CCRVDF).

4)Microbialtoxins,suchasbotulinumtoxinandstaphylococcusenterotoxin,andmicroorganismsthatarewithinthetermsofreferenceoftheCommitteeonFoodHygiene(CCFH).

5)ResiduesofprocessingaidsthatarewithinthetermsofreferenceoftheCommitteeonFoodAdditives(CCFA)(**).

(*)FeedadditivesasdefinedintheCodeofPracticeonGoodAnimalFeeding(CXC54-2004):“Any

intentionallyaddedingredientnotnormallyconsumedasfeedbyitself,whetherornotithasnutritionalvalue,whichaffectsthecharacteristicsoffeedoranimalproducts.

Residuesoffeedadditivesincludetheparentcompoundsand/ortheirmetabolitesinanyedibleportionoftheanimalproductandincluderesiduesofassociatedimpuritiesofthefeedadditiveconcerned.

(**)Processingaidsareanysubstanceormaterial,notincludingapparatusorutensils,andnotconsumedasafoodingredientbyitself,intentionallyusedintheprocessingofrawmaterials,foodsoritsingredients,tofulfilacertaintechnologicalpurposeduringtreatmentorprocessingandwhichmayresultinthenon-intentionalbutunavoidablepresenceofresiduesorderivativesinthefinalproduct.

1.2.3NaturaltoxinsincludedinthisStandard

TheCodexdefinitionofacontaminantimplicitlyincludesnaturallyoccurringtoxicantsincludingtoxicmetabolitesofcertainmicrofungithatarenotintentionallyaddedtofoodandfeed(mycotoxins).

Toxinsthatareproducedbyalgaeandthatmaybeaccumulatedinedibleaquaticorganismssuchasshellfish(phycotoxins)arealsoincludedinthisStandard.Mycotoxinsandphycotoxinsarebothsubclassesofcontaminants.

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Endogenousnaturaltoxicants,suchase.g.solanineinpotatoes,thatareimplicitconstituentsoffoodandfeedresultingfromagenus,speciesorstrainordinarilyproducinghazardouslevelsofatoxicmetabolite(s),i.e.phytotoxinsarenotgenerallyconsideredwithinthescopeofthisStandard.Theyare,however,withinthetermsofreferenceofCCCFandwillbedealtwithonacase-by-casebasis.

1.2.4Maximumlevelandrelatedterms1

TheCodexmaximumlevel(ML)foracontaminantinafoodorfeedcommodityisthemaximumconcentrationofthatsubstancerecommendedbytheCodexAlimentariusCommissiontobelegallypermittedinthatcommodity.

1.3PRINCIPLESREGARDINGCONTAMINANTSINFOODANDFEED

1.3.1General

Contaminationoffoodandfeedmayposearisktohuman(and/oranimalhealth).Moreover,insomecasestheymayalsohaveanegativeimpactonthequalityofthefoodorfeed.Foodandfeedcanbecomecontaminatedbyvariouscausesandprocesses.

ContaminantlevelsinfoodandfeedshallbeaslowasreasonablyachievablethroughbestpracticesuchasGoodAgriculturalPractice(GAP)andGoodManufacturingPractice(GMP)followinganappropriateriskassessment.Thefollowingactionsmayservetopreventortoreducecontaminationoffeedandfood2:

●Preventingfoodandfeedcontaminationatthesource,e.g.byreducingenvironmentalpollution.

●Applyingappropriatetechnologycontrolmeasure(s)infoodandfeedproduction,manufacture,processing,preparation,treatment,packing,packaging,transportorholding.

●Applyingmeasuresaimedatdecontaminationofcontaminatedfeedorfoodandmeasurestopreventcontaminatedfeedorfoodtobemarketedforconsumption.

ToensurethatadequateactionistakentoreducecontaminationoffoodandfeedaCodeofPracticeshallbeelaboratedcomprisingsourcerelatedmeasuresandGoodManufacturingPracticeaswellasGoodAgriculturalPracticeinrelationtothespecificcontaminationproblem.

Thedegreeofcontaminationoffoodandfeedandtheeffectofactionstoreducecontaminationshallbeassessedbymonitoring,surveyprogramsandmorespecializedresearchprograms,wherenecessary.

Whenthereareindicationsthathealthhazardsmaybeinvolvedwithconsumptionoffoodthatiscontaminated,itisnecessarythatariskassessmentshouldbeundertaken.Whenhealthconcernscanbesubstantiated,ariskmanagementmeasuremustbeapplied,basedonathoroughevaluationofthesituationandconsiderationofarangeofriskmanagementoptions.Dependingontheassessmentoftheproblemsandthepossiblesolutions,itmaybenecessarytoestablishMLsorothermeasurestocontrolthecontaminationoffoodandfeed.Inspecialcases,specificadviceondietaryrecommendationsmayalsohavetobeconsideredtocomplementotherregulatorymeasures,whenthemeasuresarenotsufficientlyadequatetoprotectpublichealthandsafety.

Nationalmeasuresregardingfoodandfeedcontaminationshouldavoidthecreationofunnecessarybarrierstointernationaltradeinfoodandfeedcommodities.ThepurposeoftheGSCTFFistoprovideguidanceaboutpossibleapproachestoeliminateorreducethecontaminationproblemandtopromoteinternationalharmonizationthroughrecommendations,whichinturnmaypreventtradebarriersanddisputes.

Forallcontaminants,whichmaybepresentinmorethanonefeedorfooditem,abroadapproachshallbeapplied,consideringallrelevantinformationthatisavailable,fortheassessingofrisksandfordevelopingrecommendationsandcontrolmeasures,includingthesettingofmaximumlevels.

1Forthecontaminantsradionuclides,acrylonitrileandvinylchloridemonomeraCodexguidelinelevel(GL)has

beenestablished.

ACodexguidelinelevel(GL)isthemaximumlevelofasubstanceinafoodorfeedcommoditywhichisrecommendedbytheCodexAlimentariusCommissiontobeacceptableforcommoditiesmovingininternationaltrade.WhentheGLisexceeded,governmentsshoulddecidewhetherandunderwhatcircumstancesthefoodshouldbedistributedwithintheirterritoryorjurisdiction.

BecausetheCommissionhasdecidedthatthepreferredformatofaCodexstandardinfoodorfeedisamaximumlevel,thepresentexistingorproposedguidelinelevelsshallbereviewedfortheirpossibleconversiontoamaximumlevelafterariskassessmentperformedbyJECFA,ifappropriate.

2Inaddition,referenceismadetotheCodeofPracticeforsourceDirectedmeasurestoreducecontaminationof

foodwithchemicals(CXC49-2001)andtheCodeofPracticeonGoodAnimalFeeding(CXC54-2004).

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1.3.2Principlesforestablishingmaximumlevelsinfoodandfeed

MLsshallonlybesetforfoodinwhichthecontaminantmaybefoundinamountsthataresignificantforthetotalexposureoftheconsumer,takingintoconsiderationthePolicyoftheCommitteeonContaminantsinFoodsforExposureAssessmentofContaminantsandToxinsinFoodsorFoodGroups

(SectionIVoftheProceduralManual).

Themaximumlevelsshallbesetinsuchawaythattheconsumerisadequatelyprotected.Atthesametimetheotherlegitimatefactorsneedtobeconsidered.ThiswillbeperformedinaccordancewiththeWorkingPrinciplesforRiskAnalysisforFoodSafetyforApplicationbyGovernments.

TheprinciplesofGoodManufacturingPracticeandGoodAgriculturalPracticeasdefinedbyCodexshallbeused.Maximumlevelsshallbebasedonsoundscientificprinciplesleadingtolevels,whichareacceptableworldwide,sothatthereisnounjustifiedbarriertointernationaltrade.MLsshallbeclearlydefinedwithrespecttostatusandintendeduse.

1.3.3Specificcriteria

Thefollowingcriteriashould(notpreventingtheuseofotherrelevantcriteria)beconsideredwhendevelopingMLsand/orothermeasuresinconnectionwiththeGeneralStandardforContaminantsandToxinsinFoodandFeed(FurtherdetailsaboutthesecriteriaaregiveninAnnexI).

Toxicologicalinformation

●identificationofthetoxicsubstance(s);

●metabolismbyhumansandanimals,asappropriate;

●toxicokineticsandtoxicodynamicsincludinginformationonpossiblecarry-overofthetoxicsubstancefromfeedtoedibleanimaltissue/products;

●informationaboutacuteandlong-termtoxicityandotherrelevanttoxicitydata;and

●integratedtoxicologicalexpertadviceregardingtheacceptabilityandsafetyofintakelevelsofcontaminants,includinginformationonanypopulationgroupswhichareespeciallyvulnerable.

Analyticaldata

●validatedqualitativeandquantitativedataonrepresentativesamples;and

●appropriatesamplingprocedures.

Intakedata

●presenceinfoodofdietarysignificanceforthecontaminant;

●presenceinfoodthatarewidelyconsumed;

●presenceinfeedandfeedcomponents;

●foodintakedataforaverageandmostexposed/highconsumergroups;

●resultsfromtotaldietstudies;

●calculatedcontaminantintakedatafromfoodconsumptionmodels;

●dataonintakebysusceptiblegroups;and

●dataonintakebyfoodproducinganimals.

Technologicalconsiderations

●Informationaboutcontaminationprocesses,technologicalpossibilities,productionandmanufacturingpracticesandeconomicaspectsrelatedtocontaminantlevelmanagementandcontrol.

Riskassessmentandriskmanagementconsiderations(cf.WorkingPrinciplesforRiskAnalysisforFoodSafetyforApplicationbyGovernments)

●riskmanagementoptionsandconsiderations;

●considerationofpossiblemaximumlevelsinfoodandfeedbasedonthecriteriamentionedabove;and

●considerationofalternativesolutions.

1.4FORMATOFTHEGENERALSTANDARDFORCONTAMINANTSINFOODANDFEED

AfulldescriptionoftheformatisprovidedinAnnexII.

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AnnexI

CRITERIAFORTHEESTABLISHMENTOFMAXIMUMLEVELSINFOODANDFEEDIntroduction

InthisAnnexcriteriaarementionedregardinginformation,whichisconsiderednecessaryforevaluatingcontaminantproblemsinfoodandfeedandfortheestablishmentofmaximumlevels.ThecriteriamentionedhereareelaboratedinmoredetailthaninSection1.3.3ofthePreamble.Onlythoseaspectsthatneedfurtherclarificationaredetailed;however,criteriaoraspectsthatarenotspecificallydetailedhereshouldnotberuledoutintheevaluationprocess.

Toxicologicalinformation

Integratedtoxicologicalexpertadviceregardingasafe/tolerableintakelevelofacontaminantisessentialwhendecisionsaboutmaximumlevelsinfoodsareconsidered.ArecommendationfromtheJointFAO/WHOExpertCommitteeonFoodAdditives(JECFA)regardingthemaximumallowableortolerableintake,basedonafullevaluationofanadequatetoxicologicaldatabase,shouldbethemainbasisfordecisionsbyCodexmembers.Inurgentcases,itmaybepossibletorelyonlessdevelopedevaluationsfromJECFAorontoxicologicalexpertadvicefromotherinternationalornationalbodies.

Whentoxicologicalinformationispresentedinrelationtoproposalsformaximumlevelsforcontaminantsinfoodandfeed,informationaboutthefollowingaspectsisdesirable:

●identificationofthetoxicsubstance(s);

●metabolisminhumansandanimals,asappropriate;

●toxicokineticsandtoxicodynamicsincludinginformationonpossiblecarry-overofthecontaminantfromfeedtoedibleanimaltissue/products;

●informationaboutacuteandlong-termtoxicityinanimalsandhumans,includingepidemiologicaldataonhumansandotherrelevanttoxicitydata;

●conclusionsandadviceoftoxicologicalexpert(s)(groups),withreferences,includinginformationonespeciallyvulnerablepopulationgroupsoranimals.

Analyticaldata

Validatedqualitativeandquantitativeanalyticaldataonrepresentativesamplesshouldbesupplied.Informationontheanalyticalandsamplingmethodsusedandonthevalidationoftheresultsisdesirable.Astatementontherepresentativenessofthesamplesforthecontaminationoftheproductingeneral(e.g.onanationalbasis)shouldbeadded.Theportionofthecommoditythatwasanalyzedandtowhichthecontaminantcontentisrelatedshouldbeclearlystatedandpreferablyshouldbeequivalenttothedefinitionofthecommodityforthispurposeortoexistingrelatedcontaminantregulation.

Informationonappropriatesamplingproceduresshouldbesupplied.Specialattentiontothisaspectisnecessaryinthecaseofcontaminantsthatmaynotbehomogeneouslydistributedintheproduct(e.g.mycotoxinsinsomecommodities).

Intakedata

Itisdesirabletohaveinformationaboutthecontaminantconcentrationsinthosefoodsorfoodgroupsthat(together)areresponsibleforatleasthalfandpreferably80%ormoreofthetotaldietaryintakeofthecontaminant,bothforconsumerswithaverageandhighconsumptionpatterns.

Informationaboutthepresenceofthecontaminantinfoodsthatarewidelyconsumed(staplefoods)isdesirableinordertobeabletomakeasatisfactoryassessmentofthecontaminantintakeandofrisksassociatedwithfoodtrade.

Forthecontaminants,whichcanbepresentinfoodofanimaloriginasaconsequenceofthecarry-overfromfeed,informationaboutthepresenceofthecontaminantinthefeedandfeedcomponentsshouldbegiven.Furthermore,theintakeofcontaminantsbythedifferentfoodproducinganimalsandtheresultinglevelsofthecontaminantinthefoodofanimaloriginshouldbeestimated.

Foodconsumptiondataforaverage,mostexposed(highconsumers)andsusceptibleconsumergroupsaredesirableforevaluationsof(potential)intakeofcontaminants.Thisproblem,however,hastobeaddresseddifferentlyonanationalandonaninternationalscale.Itisthereforeimportanttohaveinformationaboutbothaverageandhighconsumptionpatternsregardingawidevarietyoffoodstuffs,sothatforeverycontaminantthemostexposedconsumergroupsmaybeidentifiedforeverycontaminant.Detailedinformationabouthighconsumptionpatternsisdesirable,bothregardinggroupidentificationcriteria(e.g.ageorsexdifferences,vegetarianorregionaldietarycustoms,etc.)andstatisticalaspects.

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Dietaryintakeofcontaminants:ReferenceismadetotheGuidelinesfortheStudyofDietaryIntakeofChemicalContaminants(WHO,1985-

/offset/WHO_OFFSET_87.pdf)

.Itisimportanttosupplyallrelevantdetails,suchasthetypeofstudy(duplicatediet,totaldietormarketbasketstudy,selectivestudy),andstatisticaldetails.Calculatedcontaminantintakedatafromfoodconsumptionmodelsmayalsobeuseful.Whenresultsaboutfoodgroupsandabouteffectsofpreparationandcookingetc.areavailable,theseshouldalsobesupplied.

Technologicalconsiderations

Informationaboutthesourceofthecontaminantandthewayinwhichthefoodandfeediscontaminated,possiblyincludinginformation,ifavailable,aboutcontaminationbeingpresentinpartsonlyoftheproduct,isessentialforassessingthepossibilitiestocontrolthecontaminationprocessandtobeabletoguaranteeadesiredproductsafetyandquality.WherepossibleSource-relatedmeasuresshouldbeproposed.GoodManufacturingPractice(GMP)and/orGoodAgriculturalPractice(GAP)shouldalsobeadaptedtocontrolacontaminationproblem.Whenthisispossible,maximumlevelsmaybebasedonGMPorGAPconsiderationstoestablishatalevelaslowasreasonablyachievableandnecessarytoprotecttheconsumer.Considerationsregardingthetechnologicalpossibilitiestocontrolacontaminationproblem,e.g.bycleaning,shouldalsobeconsideredwhenaprimaryriskassessmentmodel(theoreticalmaximumdailyintake)showspossibleintakesexceedingthetoxicologicalreferencevalue.Insuchacasethepossibilitiesoflowercontaminationlevelsneedfurthercarefulexamination.Thenadetailedstudyaboutalltheaspectsinvolvedisnecessary,sothatdecisionsaboutmaximumlevelscanbebasedonathoroughevaluationofboththepublichealthargumentsandthepotentialproblemwithcomplyingwiththeproposedstandard.

Riskassessmentandriskmanagementconsiderations

RiskassessmentandriskmanagementareconductedinaccordancewiththeWorkingPrinciplesforRiskAnalysisforFoodSafetyforApplicationbyGovernments(CXG62-2007).

Establishmentofmaximumlevels

Incaseitisdecidedthat,onthebasisoftheoutcomeoftheriskassessment,thereisnoneedtoestablishamaximumleveltoprotectpublichealthasthelevelofhazard/riskdoesnotposeapublichealthproblem,thisshouldbecommunicatedinatransparentandaccessiblemanner(e.g.byusingthefullformatasprovidedforScheduleIandtomentionintheboxofMaximumlevel“notnecessary”).

Theestablishmentofmaximumlevels(MLs)ofcontaminantsinfoodandfeedinvolvesseveralprinciples,someofwhichhavealreadybeenmentionedinthisPreamble.Brieflystated,thefollowingcriteriawillhelpinmaintainingaconsistentpolicyinthismatter:

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●MLsshouldbesetonlyforthosecontaminantsthatpresentbothasignificantrisktopublichealthandaknownorexpectedproblemininternationaltrade.

●MLsshouldbesetonlyforfoodthatissignificantforthetotalexposureoftheconsumertothecontaminant.Whenidentifyingthesignificanceofcertainfoodsinthetotalexposuretothecontaminant,thecriteriacontainedinSection3ofthePolicyoftheCommitteeonContaminantsinFoodsforExposureAssessmentofContaminantsandToxinsinFoodsorFoodGroups(SectionIVoftheProceduralManual)shouldbeconsulted.

●MLsshouldbesetaslowasreasonablyachievableandatlevelsnecessarytoprotecttheconsumer.Providingitisacceptablefromthetoxicologicalpointofview,MLsshouldbesetatalevelwhichis(slightly)higherthanthenormalrangeofvariationinlevelsinfoodandfeedthatareproducedwithcurrentadequatetechnologicalmethods,inordertoavoidunduedisruptionsoffoodandfeedproductionandtrade.Wherepossible,MLsshouldbebasedonGMPand/orGAPconsiderationsinwhichthehealthconcernshavebeenincorporatedasaguidingprincipletoachievecontaminantlevelsaslowasreasonablyachievableandnecessarytoprotecttheconsumer.Foodsthatareevidentlycontaminatedbylocalsituationsorprocessingconditionsthatcanbeavoidedbyreasonablyachievablemeansshallbeexcludedinthisevaluation,unlessahigherMLcanbeshowntobeacceptablefromapublichealthpointofviewandsignificanteconomicaspectsareatstake.

●ProposalsforMLsinproductsshouldbebasedondatafromvariouscountriesandsources,encompassingthemainproductionareas/processesofthoseproducts,asfarastheyareengagedininternationaltrade.Whenthereisevidencethatcontaminationpatternsaresufficientlyunderstoodandwillbecomparableonaglobalscale,morelimiteddatamaybeenough.

●MLsmaybesetforproductgroupswhensufficientinformationisavailableaboutthecontaminationpatternforthewholegroup,orwhenthereareotherargumentsthatextrapolationisappropriate.

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●NumericalvaluesforMLsshouldpreferablyberegularfiguresinageometricscale(0.01,0.02,0.05,0.1,0.2,0.5,1,2,5etc.),unlessthismayposeproblemsintheacceptabilityoftheMLs.

●MLsshouldapplytorepresentativesamplesperlot.Ifnecessary,appropriatemethodsofsamplingshouldbespecified.

●MLsshouldnotbelowerthanalevelwhichcanbeanalyzedwithmethodsofanalysisthatcanreadilybesetupandappliedinfoodandfeedcontrollaboratories,unlesspublichealthconsiderationsnecessitatealowerMLwhichcanonlybecontrolledbymeansofamoreelaborateandsensitivemethodofanalysiswithanadequatelowerdetectionlimit.Inallcases,avalidatedmethodofanalysisshouldbeavailablewithwhichaMLcanbecontrolled.

●ThecontaminantasitshouldbeanalyzedandtowhichtheMLappliesshouldbeclearlydefined.Thedefinitionmayincludeimportantmetaboliteswhenthisisappropriatefromananalyticalortoxicologicalpointofview.Itmayalsobeaimedatindicatorsubstanceswhicharechosenfromagroupofrelatedcontaminants.

●TheproductasitshouldbeanalyzedandtowhichtheMLapplies,shouldbeclearlydefined.Ingeneral,MLsaresetonprimaryproducts.MLsshouldingeneralpreferablybeexpressedasalevelofthecontaminantrelatedtotheproductasitis,onafreshweightbasis.Insomecases,however,theremaybevalidargumentstopreferexpressiononadryweightbasis(thismightbeinparticularthecaseforcontaminantsinfeed)oronafatweightbasis(thismightbeinparticularthecaseforfatsolublecontaminants).Preferablytheproductshouldbedefinedasitmovesintrade,withprovisionswherenecessaryfortheremovalofinediblepartsthatmightinterferewiththepreparationandtheanalysisofthesample.TheproductdefinitionsusedbyCCPRandcontainedintheClassificationofFoodandFeed(CXM4-1989)mayserveasguidanceonthissubject;otherproductdefinitionsshouldonlybeusedforspecifiedreasons.Forcontaminantpurposes,however,analysisandconsequentlyMLsshouldpreferablybeonthebasisoftheediblepartoftheproduct.

Forfat-solublecontaminants,whichmayaccumulateinanimalproducts,provisionsshouldbeappliedregardingtheapplicationoftheMLtoproductswithvariousfatcontent(comparabletotheprovisionsforfatsolublepesticides).

●GuidanceisdesirableregardingthepossibleapplicationofMLsestablishedforprimaryproductstoprocessedproductsandmulti-ingredientproducts.Whenproductsareconcentrated,driedordiluted,useoftheconcentrationordilutionfactorisgenerallyappropriateinordertobeabletoobtainaprimaryjudgementofthecontaminantlevelsintheseprocessedproducts.Themaximumcontaminantconcentrationinamulti-ingredientfoodandfeedcanlikewisebecalculatedfromthecompositionofthefoodandfeed.Informationregardingthebehaviorofthecontaminantduringprocessing(e.g.washing,peeling,extraction,cooking,dryingetc.)ishoweverdesirabletogivemoreadequateguidance.Whencontaminantlevelsareconsistentlydifferentinprocessedproductsrelatedtotheprimaryproductsfromwhichtheyarederived,andsufficientinformationisavailableaboutthecontaminationpattern,itmaybeappropriatetoestablishseparatemaximumlevelsfortheseprocessedproducts.Thisalsoapplieswhencontaminationmayoccurduringprocessing.Ingeneral,however,MLsshouldpreferablybesetforprimaryagriculturalproductsandmaybeappliedtoprocessed,derivedandmulti-ingredientfoodandfeedbyusingappropriateconversionfactors.Whenthesefactorsaresufficientlyknown,theyshouldbementionedinthesuffixtothemaximumlevelfollowingtheformatoflistofMLsasdefinedinAnnexII.

●MLsshouldpreferablynotbesethigherthanisacceptableinaprimary(theoreticalmaximumintakeandriskestimation)approachoftheiracceptabilityfromapublichealthpointofview.WhenthisposesproblemsinrelationtoothercriteriaforestablishingMLs,furtherevaluationsarenecessaryregardingthepossibilitiestoreducethecontaminantlevels,e.g.byimprovingGAPand/orGMPconditions.Whenthisdoesnotbringasatisfactorysolution,furtherrefinedriskassessmentandcontaminantriskmanagementevaluationswillhavetobemadeinordertotrytoreachagreementaboutanacceptableML.

Procedureforriskassessmentinrelationto(proposed)MLs

Itismoredifficulttocontrolfoodandfeedcontaminationproblemsthaninthecaseoffoodadditivesandpesticideresidues.ProposedMLswillinevitablybeinfluencedbythissituation.InordertopromoteacceptanceofCodexMLs,itisthereforeimportantthatassessmentsoftheimpactofthoseMLsondietaryexposurea