进口饲料饲料添加剂申报指南.docx
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进口饲料饲料添加剂申报指南
进口饲料、饲料添加剂申报指南
ApplicationGuidelinesfor
RegistrationofImportedFeedsandFeedAdditives
NationalFeedIndustryOffice
April,2004
Address:
NationalFeedIndustryOffice,MinistryofAgriculture
No.11,NongzhanguanNanli,Beijing,P.R.ofChina.100026
Tel:
8610-64192831
Fax:
8610-64192869
Introduction
FeedsandFeedAdditivesAdministrationRegulationandAdministrativeMeasuresfortheRegistrationofImportedFeedsandFeedAdditivesspecifythatforeignenterprisesshallapplytotheMinistryofAgricultureofthePeople'sRepublicofChina(MOA)toobtainproductregistrationlicensefortheirfeedandfeedadditiveproductsiftheyaretobeplaceonthemarketforthefirsttimewithintheterritoryofthePeople'sRepublicofChina.Forthosefeedsandfeedadditiveswithnoregistrationlicense,theyarenotallowedtobesoldorusedintheterritoryofChina.Inthepracticeofapplication,wefoundthatsomeproducersanddistributorsareunfamiliarwithChina’sfeedregulations,henceresultinginmaterialssubmittedintheapplicationsbeinginadequateorpresentationsunclear.ThisApplicationGuidelineswasthencompiledtohopefullypromotesmoothregistrationproceduresforimportedfeedsandfeedadditives.
CONTENTS
1ScopeandCoverageforRegistration
2CommonTerminologyforFeedIndustry
3ProceduresofApplicationforlicensesofimportedfeedsandfeedadditives
3.1AskingforApplicationFormandCategoryofRequiredMaterials
3.2Application
3.3AppraisaloftheApplicationMaterials
3.4ProductInspection
3.5LicenseIssuing
3.6InquiriesofregistrationLicense
4ApplicationFormandRequiredMaterials
4.1FormatRequirementforApplicationMaterials
4.2FillinginApplicationForm
4.3ContentsofRequiredMaterials
4.4AdditionalInformationforPetFoodandAquacultureFeed
4.5RelatedRegulationsandInterpretationforLicenseApplication
5SampleRequirements
6ApplicationforRe-registration
6.1AskingforRe-registrationForm
6.2RequiredMaterialsforRe-registration
6.3RelatedRegulationsforRe-registration
Appendix:
1.ApplicationFormforRegistrationofImportedFeedsandFeedAdditives
2.ASampleoftheApplicationForm
3.FlowchartofAppraisalofimportedFeedsandFeedAdditives
4.ASampleofChineseLabel
5.ProductClassification
6.ApplicationMaterialsforAppraisalofImportedProducts
7.Re-registrationFormforImportedFeedsandFeedAdditives
ApplicationGuidelinesfor
RegistrationofImportedFeedsandFeedAdditives
1ScopeandCoverageforRegistration
FeedsandfeedadditivestobeimportedtotheP.R.ofChina.
2CommonTerminologyforFeedIndustry(SeeGB10647-89)
2.1Feedstuff(SingleFeed)
Feedstufforiginatedfromonlyonekindofanimal,plant,microbialormineralsource.
2.1.1EnergyFeed
Feedstuffwithlessthan18%crudefiberandlessthan20%crudeproteinondrymatterbasis.
2.1.2ProteinFeed
Feedstuffwithlessthan18%crudefiberand20%ormorecrudeproteinondrymatterbasis.
2.2CompleteFeed
Compoundfeedwhichcanmeetthenutritionrequirementsfromraisedanimals(exceptofwater).
2.3ConcentrateFeed
Mixtureofproteiningredients,traceminerals,vitaminsandnon-nutritionalfeedadditivesaccordingtoacertainformula.
2.4ConcentrateSupplement
Compoundfeedmixedatacertainformulawithmanykindsoffeedingredientstosupplementnutritionforherbivorousanimalsfedonroughage(dry,freshorsilage).
2.5AdditivePremix
Premixofmorethantwokindsoffeedadditiveswithcarriersordiluentsatacertainformula.
2.6CompoundPremix
Premixoftwoormorekindsoffeedadditivesinthecategoryoftraceminerals,vitamins,aminoacidsandnon-nutritionalfeedadditiveswithcarriersordiluentsatacertainformula.
2.7FeedAdditive
Minorortraceingredientsaddedduringfeedprocessing,productionorutilization.Theywerecategorizedintonutritiveandnon-nutritivefeedadditives.
2.7.1NutritiveAdditive
Traceorminorsubstancetosupplementnutritioninfeed
2.7.2Non-nutritiveAdditive
Minorortracesubstanceaddedinthefeedtoensureorimprovefeedquality,promoteanimalproduction,ensureanimalhealthandimprovefeedutilizationefficiency.
a.Anti-oxidant:
Additiveaddedtopreventordelayoxidationordamageofsomeactiveingredientsinthefeed.
b.Preservative:
Additiveaddedtopreventorinhibitfermentationordecayingoffeed.
c.Mouldinhibitor:
Additivesaddedtopreventmoldgrowthinthefeed.
d.Flavorenhancement:
Additivesaddedinthefeedtoimprovefeedpalatabilityandanimalappetite.
e.Colorpigment:
Additivesaddedtoimprovecolorofanimalproductsorfeed.
f.Binder:
Additiveaddedinthefeedtoimprovemoldingcapacityofmashfeedoranti-shapedamagingcapacityofpelletfeed.
2.7.3SeeAppendix5forexamplesofdifferentproducts.
3ProceduresofApplicationforLicensesofImportedFeedsandFeedAdditives(SeeAppendix3forFlowChart)
3.1AskingforApplicationFormandCategoryofRequiredMaterials
3.1.1ThesedocumentscanbeacquiredfromNationalFeedIndustryOffice(NFIO).
3.1.2Downloadedfrom(ApplicationDocumentsatleftbottomsectiononhomepage).
3.2Application
AnApplicantshallsubmitoriginalcopyofapplicationmaterialstoNFIO.ApplicationmaterialsincludeApplicationFormforRegistrationofImportedFeedsandFeedAdditives(seeAppendix1)andMaterialsRequiredforSubmission.
3.3AppraisaloftheApplicationMaterials
NFIOshallcompletetheappraisaloftheapplicationmaterialswithin15workingdaysandinformtheapplicantoftheappraisalresult.
a.Ifapplicationmaterialsdonotmeetrequirements,NFIOshallinformtheapplicantviafaxtomakesupplementsorcorrections.Applicationshallnotbeacceptedunlessrequiredmaterialsaresupplementedorcorrectedinlinewithrelatedregulations.Documentsthatfailtomeetrequirementswillnotbeaccepted.
b.Ifapplicationmaterialsmeetrequirements,NFIOshallinformtheapplicantinaNoteofAcceptancetosendacopyofapplicationdocuments,samples,NoteofAcceptanceandtestfees(chargedbytestitems)toMOAFeedQualityInspectionCenter(FQIC)specifiedintheNoteforproductqualityinspection.
3.4ProductInspection
FQICshallsubmittestresultstoNFIO.
a.Ifaproductisqualified,FQICshallprepareandsubmitatestreporttoNFIO.
b.Iftheproductisnotqualified,FQICshallinformtheapplicanttosubmitsamplesforasecondtest.Andifthesecondteststillfail,thisproductshallnotberegisteredintheP.R.ofChina.
FQICshallnotreleasetestreporttotheapplicantandtheapplicantshallnotrequestthereportoritscopies.
3.5LicenseIssuing
QualifiedFeedsandFeedadditivesshallbesubmittedtoMOAforAppraisal.OnceapprovedbyMOA,alicensewillbeissued.
3.5.1NFIOwillinformtheapplicantaboutthedateforreleasingthelicenseorfailureofanyproducttoberegistered.
3.5.2TheapplicantshallpayregistrationfeeofRMB8300yuan(remittance,cashorcheckisacceptableexceptforUSDcash)toDepartmentofFinanceofMOAuponobtainingthelicense.
3.6InquiriesofregistrationLicense
TheapprovalofregistrationwillbeannouncedonMOABulletinandalsoonthewebsite:
.Anapplicantcaninquireaboutcommodityname,manufacturerandregistrationnumberofanyapprovedproduct.
4ApplicationFormandRequiredMaterialsRequired
4.1Formatrequirementforapplicationmaterials
a.Onesetoforiginalapplicationmaterialsandacopyofitshallbesubmittedforeachproduct.
b.TheapplicationmaterialsshallbeinbothChineseandEnglish,withChineseversioncomingfirst.
c.TheEnglishversionshallbeprintedonformalstationerypaperheadingwithmanufacturer’snameandwithsignatureorseals.
d.TheChinesetranslationoftheapplicationmaterialsshallbethesamewiththeEnglishversion,andunrelatedinformationabouttheproductsshallnotbesubmitted.
e.IfmaterialssubmittedbythemanufacturerarenotinEnglish,theyshallbetranslatedintoEnglishandChinese.
f.ApplicationmaterialsinChineseshallbeprintedwithA4paper,in#4orsmall#4fonts.There’snospecificlimitationsfortheEnglishversion.
g.ApplicationFormshallbeonthefirstpageofthewholesetofapplicationmaterials,whichshallbeboundedindurabledocumentfolders.
4.2FillinginApplicationForm(PleaseseeAppendix2fortheSample)
4.2.1Commodityname
ImportedfeedandfeedadditivesmarketedintheP.R.ofChinashallhaveaChinesename,whichshallbedefinedaccordingtoGB/T10647Standard.Aproductshallbenamedafteritsrealnature,insteadofasimpletranslationoftheEnglishpronunciation.
4.2.2Commonname
Itmeansanamethatcanreflectthenatureofafeedandfeedadditive.
4.2.3Productclassification(SeeAppendix5)
RefertoCommonTerminologyInFeedIndustry(SeeSection2).
4.2.4Appearance
Itmeanscolor,shape(mash,pellet,crystalandblock)andphysicalproperties(e.g.odor,solidityorliquidity)
4.2.5Majorandminoringredientsandtheircontents
Specificationforkeynutritionshouldbefilledintheblankunder“keyingredientandcontent”.
Otheritemssuchasspecificationofhygieneandheavymetalshallbefilledinunder“otheringredientandcontent”.
4.2.6Manufacturer’snameandaddress
Detailednameandaddressofthemanufacturershallbefilledinasexactlythesameasindicatedinthefreesalecertificate,exceptthat
a.Anapplicantisagroupcompany:
Nameoftheproducershallbegiven,thoughthegroupcompany,towhichtheproducerisaffiliated,shallberegisteredastheapplicant.Ifthegroupcompanyproducesasameproductindiffe