欧盟与中国植物药标准的比较研究

©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.:2008212210:(19822),(),,,,.,(,):,,;,,,:;;;:R288:B:100820805(2009)0521286203WTO,WTO/TBT(AgreementonTechnicalBarrierstoTradeoftheWorldTradeOr2ganization),3[1]WTO/TBT,,,,,,,:NutritionBusinessJournal(NBJ)180[2];[3],,[4],70,32%[5],2[6],20042004/24/EC,,1,(MA),,[7],2007,36(theConventionontheElaborationofaEuropeanPhar2macopoeia),620082012011.1[8]4:(Traditionalherbalmedicinalproduct)(Herbalsubstance)(Herbalpreparation)(Herbalmedicinalproduct)[9]:(herbaldrug)(herbalextract)(herbaldrugspreparation)(herbaltea)4,[10]1.1.1,,,,(),,,[11],,2005,,,,,,(Rhubarb),Rheumpalma2tumL.RheumtanguticumMaximexBalfRheumofficinaleBaill,RheumpalmatumL.RheumofficinaleBaillon1.1.2,,(herbaldrugspreparation)(Herbalpreparation),(),,;,,,200531,,,,,1.1.3,68212009205LISHIZHENMEDICINEANDMATERIAMEDICARESEARCH2009VOL.20NO.5©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.[12],,,(herbaltea),,(herbalmedicinalproducts),,,,,,,2002,,2005(),,,,,,,,:,;,;,,,,[11]1.2,,,,,:,(foreignmat2ter)(lossondrying);;,:(totalash)(ashinsolubleinhydrochloricacid)(extractablematter)(swellingindex)(bitternessvalue);(water);,(pesticideresidues)(heavymetal);;,1.2.1,,,2%(),,,,1.2.21997FAOWHO[13]WHO[14],,116/mgkg-1Regulation(EC)No396/2005/mgkg-1Alachlor()0.020.05AldrinandDieldrin(sumof)()0.050.02Azinphos-menthyl()1.00.1Bromopropylate()3.00.5Chlordane(sumofcis-,trans-andOxyth2lordane)()0.050.02Chlorfenvinphos()0.50.05Chlorpyrifos()0.20.5/0.1Chlorpyrifos-methyl()0.10.2/0.1Cypermethrin(andisomers)()1.00.1DDT(p,p’-DDT,o,p’-DDT,p,p’-DDEandp,p’-TDE)1.00.5/0.2Deltamethrin()0.50.05Diazinon()0.50.02Dichlorvos()1.00.02Dithiocarbametes(asCS2)()2.00.1Endosulfan(sumofisomersandEndosulfansulphate)()3.00.5/0.1Endrin()0.050.1Ethion()2.00.02Fenitrothion()0.50.5/0.02Fenvalerate()1.51.0Fonofos()0.05--Heptachlor(sumofHeptachlorandHepta2chlorepoxide)()0.050.1/0.02Hexachlorobenzene()0.10.02Hexachlorocyclohexaneisomers(otherthang)()0.30.02Lindane(g-Hexachlorocyclohexane)()0.61.0/0.05Malathion()1.0--Methidathion()0.20/5/0.1Parathion()0.50.1Parathion-methyl()0.20.05Permethrin()1.00.1Phosalone()0.10.1Piperonylbutoxide()3.0--Pirimiphos-methyl()4.00.3/0.05Pyrethrins(sumof)()3.00.5Quintozene(sumofquintozene,pentachloroan2ilineandmethylpentachlorophenylsulphide)()1.00.1/0.052005202223Regulation(EC)No396/2005(Maximumpes2ticidelevelsforfoodproductsforhumanconsumptionandanimalfeedingstuffs)[15](themaximumresiduelevels,MRLs),(Direc2tive76/895/EEC,Directive86/362/EEC,Directive86/363/EEC,Directive90/642/EEC),2008209201Regulation(EC)No396/2005Regulation(EC)No178/2006,,,[16],390,16.034,,1%7821LISHIZHENMEDICINEANDMATERIAMEDICARESEARCH2009VOL.20NO.52009205©1994-2009ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.:103cfu/gcfu/ml,102cfu/gcfu/ml;(1g1ml),22(,103cfug-1cfu/ml)()104cfu/gcfuml-1107cfu/gcfu/ml105cfu/gcfu/ml102cfu/gcfu/ml105cfu/gcfu/ml104cfu/gcfu/ml102cfu/gcfu/ml;102cfu/gcfu/ml103cfu/gcfu/ml;(10g10ml)(1g1ml)(1g1ml)(10g10ml)(1g1ml),,20072012007210,2009201[17],,3,,,,[1820]1.2.4,,2g/kgB1,B1,B2,G1G24g/kg2,,,,,,,,,,,,,,,,1/101%,,,,,,,,,,,:[1]Technicelbarrierstotrade[EB/OL].[2]TheGlobalNutritionIndustryVI[J].NutritionBusinessJournal,2007,12,(5/6):1.[3].()[J].,2004,(10):4,46.[4](2006-2020).(20062020)[EB/OL].[5]RobertRiedl.OverviewoftheGlobalHerbMarketplace.NativeFoodandEssentialOilsconvention,14th-16thAugust2003:.[6],.152007[J].,2008,10(02):41.[7][8][9]TheEuropeanMedicineAgency.EuropeanPharmacopoera6.0th[EB/OL].[10].[S].:,2005.[11][12].[J].,2004,26(4):195.[13]Qualitycontrolmethodsformedicinalplantmaterials.Geneva,WorldHealthOrganization,1998.[14]Guidelinesforpredictingdietaryintakeofpesticideresidues,2ndrev.ed.Geneva,WorldHealthOrganization,1997(unpublisheddocumentWHO/FSF/FOS/97.7;availablefromFoodSafety,WHO,1211Ge2neva27,Switzerland).[15]Regulation(EC)No396/2005[EB/OL].[16]theEuropeanPharmacopoeia6thsupplement6.2.[EB/OL]TheEu2popeanMedicineAgency.[17]PROJECTEDTIMETABLEFORPUBLICATIONANDIMPLEMENTA2TIONOFTEXTSSIGNEDOFFBYTHEPHARMACOPOEIALDIS2CUSSIONGROUP(PDG),PHARMEUROPAVol.20,No.1,Janu2ary2008,165.[18],,.[J].,2005,6(3):148.[19],,.[J].,2002,3(1):15.[20],,.20002005[J].,2007,26(10):1211.88212009205LISHIZHENMEDICINEANDMATERIAMEDICARESEARCH2009VOL.20NO.5