CACMISC 5-1993, Amended 2003 GLOSSARY OF TERMS AND

CAC/MISC5-1993Page1of4GLOSSARYOFTERMSANDDEFINITIONS(ResiduesofVeterinaryDrugsinFoods)(CAC/MISC5-1993,Amended2003)FOREWORDTheGlossaryofTermsandDefinitionshasbeenelaboratedbytheCodexCommitteeonResiduesofVeterinaryDrugsinFoods(CCRVDF)withaviewtowardsprovidinginformationandguidancetotheCommittee,andisintendedforinternalCodexuseonly.TheGlossaryisintendedtobeanopenlistwhichissubjecttoreviewbytheCCRVDFinordertoupdate,modifyoraddtothelistofterms.RelevanttermselaboratedbyotherCodexCommitteesareincluded.AttentionisdrawntotheNotesfollowing.1.AcceptableDailyIntake(ADI):AnestimatebyJECFAoftheamountofaveterinarydrug,expressedonabodyweightbasis,thatcanbeingesteddailyoveralifetimewithoutappreciablehealthrisk(standardman=60kg)(SeeNote3).2.BioavailableResidues:Thoseresiduesthatcanbeshown,bymeansofanappropriatemethod(e.g.Gallo-Torresmethod)tobeabsorbedintosystemiccirculationwhenfedtolaboratoryanimals(SeeNote3).3.BoundResidue:Residuesderivedfromthecovalentbindingoftheparentdrugorametaboliteofthedrugandacellularbiologicalsolubleorinsolublemacromolecule.Theseresiduesarenotextractablefromthemacromoleculebyexhaustiveextraction,denaturationorsolubilizationtechniques.Theydonotresultfromtheincorporationofmetabolized,radiolabelledfragmentsofthedrugintoendogenouscompounds,orthesamemacromoleculebynormalbiosyntheticpathways.InformationconcerningthecalculationofboundresiduesmaybefoundinAnnex3ofthe34thReportofJECFA(pages58-61,WHOTRS788).4.Egg1Thefreshedibleportionofthespheroidbodyproducedbyfemalebirds,especiallydomesticfowl.PortionofthecommoditytowhichtheMRLapplies:Theedibleportionoftheeggincludingtheyolkandeggwhiteafterremovaloftheshell5.ExtractableResidue:Thoseresiduesextractedfromtissuesorbiologicalfluidsbymeansofaqueousacidicorbasicmedia,organicsolventsand/orhydrolysiswithenzymes(e.g.sulfataseorglucuronidase)tohydrolyzeconjugates.Theextractionconditionsmustbesuchthatthecompoundsofinterestarenotdestroyed(SeeNote2).6.Fat1:Thelipid-basedtissuethatistrimmablefromananimalcarcassorcutsfromananimalcarcass.Itmayincludesubcutaneous,omentalorperirenalfat.Itdoesnotincludeinterstitialorintramuscularcarcassfatormilkfat.PortionofthecommoditytowhichtheMRLapplies:Thewholecommodity.Forfat-solublecompoundsthefatisanalysedandMRLsapplytothefat.Forthosecompoundswherethetrimmablefatisinsufficienttoprovideasuitabletestsample,thewholecommodity(muscleandfatbutwithoutbone)isanalysedandtheMRLappliestothewholecommodity(e.g.,rabbitmeat).1Amendmentadoptedbythe26thSessionoftheCodexAlimentariusCommission.CAC/MISC5-1993Page2of47.Fish:Meansanyofthecold-bloodedaquaticvertebrateanimalscommonlyknownassuch.ThisincludesPisces,ElasmobranchsandCyclostomes.Aquaticmammals,invertebrateanimalsandamphibiansarenotincluded.Itshouldbenoted,however,thatthistermmayalsoapplytocertaininvertebrates,particularlyCephalopods.8.GoodPracticeintheUseofVeterinaryDrugs(GPVD):Istheofficialrecommendedorauthorizedusageincludingwithdrawalperiods,approvedbynationalauthorities,ofveterinarydrugsunderpracticalconditions(SeeNote1).9.MarkerResidue:Aresiduewhoseconcentrationdecreasesinaknownrelationshiptotheleveloftotalresiduesintissues,eggs,milkorotheranimaltissues.Aspecificquantitativeanalyticalmethodformeasuringtheconcentrationoftheresiduewiththerequiredsensitivitymustbeavailable(SeeNote3).10.MaximumResidueLimitforVeterinaryDrugs(MRLVD):Isthemaximumconcentrationofresidueresultingfromtheuseofaveterinarydrug(expressedinmg/kgorìg/kgonafreshweightbasis)thatisrecommendedbytheCodexAlimentariusCommissiontobelegallypermittedorrecognizedasacceptableinoronafood(SeeNote1).ItisbasedonthetypeandamountofresidueconsideredtobewithoutanytoxicologicalhazardforhumanhealthasexpressedbytheAcceptableDailyIntake(ADI),oronthebasisofatemporaryADIthatutilizesanadditionalsafetyfactor.Italsotakesintoaccountotherrelevantpublichealthrisksaswellasfoodtechnologicalaspects.WhenestablishinganMRL,considerationisalsogiventoresiduesthatoccurinfoodofplantoriginand/ortheenvironment.Furthermore,theMRLmaybereducedtobeconsistentwithgoodpracticesintheuseofveterinarydrugsandtotheextentthatpracticalanalyticalmethodsareavailable.11.Meat:Theediblepartofanymammal.12.Milk1:Milkisthenormalmammarysecretionofmilkinganimalsobtainedfromoneormoremilkingswithouteitheradditiontoitorextractionfromit,intendedforconsumptionasliquidmilkorforfurtherprocessing.PortionofthecommoditytowhichtheMRLapplies:CodexMRLsforfat-solublecompoundsinmilkareexpressedonawholecommoditybasis.13.Muscle1:Muscleistheskeletaltissueofananimalcarcassorcutsofthesetissuesfromananimalcarcassthatcontainsinterstitialandintramuscularfat.Themusculartissuemayalsoincludebone,connectivetissue,tendonsaswellasnervesandlymphnodesinnaturalportions.Itdoesnotincludeedibleoffalortrimmablefat.PortionofthecommoditytowhichtheMRLapplies:Thewholecommoditywithoutbones.14.Non-ExtractableResidues(SeeNote2):Theseresiduesareobtainedbysubtractingtheextractableresiduesfromthetotalresiduesandcomprise:i)Residuesofthedrugincorporatedthroughnormalmetabolicpathwaysintoendogenouscompounds(e.g.aminoacids,proteins,nucleicacid)