產(chǎn)品加拿大注冊(cè)要求

1、2.2RegistrationRequirementsforSpecialtyProductsThetypesofmixedfeedsforwhichasubmissionforaspecialtyproductregistrationisrequiredinclude,butarenotlimitedto,thefollowing:該類注冊(cè)適用于Acidifiers酸化劑Anion/CationBalanceFeeds陰陽離子平衡飼料Antioxidants抗氧化劑BufferFeeds緩沖劑RumenBypassFeeds過瘤胃飼料ForageAdditives(bacterialsila

2、geinoculants,nutritiveadditives,mouldinhibitors)飼料添加劑OdourControlAgents調(diào)味劑PelletBinders球團(tuán)粘結(jié)劑ViableMicrobialandYeasts微生物和酵母EnzymeProducts酶Anymixedfeedorsingleingredientfeedmakingnutritionaland/oranimalproductionclaimsAdministrativeRequirementsStandardregistrationrequirementsasindicatedinChapter1.標(biāo)準(zhǔn)注冊(cè)

3、要求見Chapter1Proposedlabelsmustreflectthepurposeoftheproductandthestandards,packagingandlabellingrequirementsoftheFeedsActandRegulations.Guaranteesfornutrientsand/oractiveingredientsmustappearontheproductlabel.Fivecopiesoftheproposedlabelandacopyoftheproductformulation(e.g.,percentagecomposition)arere

4、quiredforsubmission.建議的標(biāo)簽必須反映產(chǎn)品的用途和飼料的標(biāo)準(zhǔn)、包裝和標(biāo)簽的要求。對(duì)營養(yǎng)成分和/或活性成分的保證必須出現(xiàn)在產(chǎn)品標(biāo)簽上。提交的標(biāo)簽和產(chǎn)品配方(如百分比組成)的五份副本須提交。ProductDescriptionandSupportingInformationAcompletelistofingredientsidentifiedbygenericnameisrequired,aslistedinScheduleIVorVoftheFeedsRegulations.RegistrationnumbersforPartIIingredients,mixedfeeds

5、,andotherregisteredproductsmustalsobeincluded.根據(jù)飼料條例附表IV或V的規(guī)定，需要列出由通用名稱識(shí)別的所有成份。第二部分配料、混合飼料和其他注冊(cè)產(chǎn)品的登記號(hào)碼也必須包括在內(nèi)。MixedfeedsmaycontainingredientsthatarenotlistedineitherScheduleIVorVoftheFeedsRegulations.Iftheapplicantwishestouseacurrentlyunapprovedfeedingredientaspartoftheproductformulationinquestion,i

6、tisalsonecessarytosubmitanapplicationforregistrationtohavetheingredientapprovedforuseinlivestockfeedsinCanadapriortosubmittingtheapplicationpackageforthespecialtyproductinquestion.Informationconcerningtheapplicationprocessfornewfeedingredientscanbefoundinsection2.3.SingleIngredientFeedEvaluationRequ

7、irements.NotethattheapplicationforregistrationforthespecialtyproductcannotbeapprovedunlessalloftheingredientsusedintheproductformulationareapprovedandlistedineitherScheduleIVorVoftheFeedsRegulations(i.e.theapplicationwillbeplacedonhold).混合飼料可能含有不列入附表IV或V的飼料規(guī)則的成分。目前如果申請(qǐng)人希望使用未經(jīng)批準(zhǔn)的飼料成分的產(chǎn)品配方問題，它也需要提交一個(gè)申

8、請(qǐng)注冊(cè)批準(zhǔn)用于牲畜飼料的成份在加拿大之前提交的應(yīng)用程序包專業(yè)生產(chǎn)問題。關(guān)于新飼料成分的應(yīng)用程序的信息可以在第2.3節(jié)中找到。單一配料飼料評(píng)價(jià)要求。請(qǐng)注意，I除非產(chǎn)品配方中所使用的所有成分經(jīng)批準(zhǔn)并列在飼料規(guī)例附表IV或V中(即申請(qǐng)將被擱置)，否則無法批準(zhǔn)該專業(yè)產(chǎn)品的注冊(cè)申請(qǐng)Theintendedpurposeofthefeed(toassistindesignatingthenameofthefeed,e.g.,anion/cationbalancefeed,flavouringagent,antioxidant,forageadditive)isalsorequired.飼料的預(yù)定用途(協(xié)助指

9、定飼料的名稱，如陰離子/陽離子平衡飼料，調(diào)味劑，抗氧化劑，飼料添加劑)也是必需的Scientificstudiesmustbepresentedinsupportofeachlabelclaim.Theseinvestigationsmustmeetthefollowingcriteria:必須提出科學(xué)研究以支持每個(gè)標(biāo)簽的要求。這些調(diào)查必須符合下列標(biāo)準(zhǔn)：theyarecarriedoutbyqualifiedresearchpersonnel;由合格的研究人員進(jìn)行theyareperformedusingthetargetlivestockspecies;它們是使用目標(biāo)牲畜物種進(jìn)行的；they

10、arecarriedoutusingsuitable/recognizedscientificmethodsandprotocols;使用適當(dāng)/認(rèn)可的科學(xué)方法和方案進(jìn)行；theyaredesignedtofacilitatestatisticalanalysis(i.e.,usingasuitablestatisticalmodel,propersamplingprotocolandsufficientsamplesize);它們的設(shè)計(jì)是為了便于統(tǒng)計(jì)分析(即:使用適當(dāng)?shù)慕y(tǒng)計(jì)模型、適當(dāng)?shù)某闃臃桨负妥銐虻臉颖救萘?；scientificdataareanalysedusingappropriates

11、tatisticalmethods;使用適當(dāng)?shù)慕y(tǒng)計(jì)方法分析科學(xué)數(shù)據(jù)；theyconsistofatleastonecontrolgroupandonetreatmentgroup;它們包括至少一個(gè)對(duì)照組和一個(gè)治療組；theyshowasignificantdifference(P0.05)betweenthecontrolandtreatmentgroups;:對(duì)照組與治療組間差異有統(tǒng)計(jì)學(xué)意義(P0.05)；theyindicatethattheproduct,whenusedasdirected,resultsinasignificantimprovementinoneormorenutri

12、tional/animalproductionclaimsfortheproduct;他們指出，該產(chǎn)品在使用時(shí)，對(duì)產(chǎn)品的一個(gè)或多個(gè)營養(yǎng)/動(dòng)物生產(chǎn)要求有顯著改善；wherethedirectionsforuseindicatearangeofinclusionrates,thetestingprotocolmustevaluatethelowestinclusionrate;如果使用說明表明了包含率的范圍，則測(cè)試協(xié)議必須評(píng)估最低包含率；theyareconductedunderconditions(i.e.,climate,managementandfeedpractices)similarto

13、thosethatmaybeexpectedtooccurinCanada;and他們是在條件下進(jìn)行的(氣候，管理和飼料的做法)類似于那些可能會(huì)發(fā)生在加拿大。wheretheresultsofthesestudieshavenotbeenpublishedinapeer-reviewedjournal,copiesoftherawdataandprintoutsofstatisticalanalysisaresuppliedforreviewbytheFeedProgram.這些研究的結(jié)果沒有發(fā)表在同行評(píng)議的期刊上，提供了原始數(shù)據(jù)和統(tǒng)計(jì)分析打印輸出的副本，供飼料項(xiàng)目審查Certificates

14、ofanalysisarerequiredfromthreedifferentandrecentlotsofproduct,inadditiontoanaccompanyinganalyticalmethodologytosubstantiatetheguarantee(s)thatappearontheproductlabel.分析的證書需要從三種不同的和最近的產(chǎn)品中獲得，此外還有一種分析方法來證實(shí)產(chǎn)品標(biāo)簽上出現(xiàn)的保證。Qualitycontrolproceduresdemonstratingproductconsistencyarerequired,ifapplicable.質(zhì)量控制程序演

15、示產(chǎn)品的一致性，如果適用的話。Productsample(s)(forproductssuchasforforageadditives,direct-fedmicrobialsandenzymesupplements)mayberequestedbytheevaluationofficerorFeedLaboratorytoverifyanalyticalmethodologiesand/orlabelguarantees.產(chǎn)品樣品(如用于飼料添加劑、直接喂養(yǎng)的微生物和酶補(bǔ)充物)可由評(píng)估人員或飼料實(shí)驗(yàn)室要求，以驗(yàn)證分析方法和/或標(biāo)簽的保證Stability(i.e.,shelflife)inf

16、ormationmustbesubmitted,ifapplicable.Tosupportproductstability,itwillbenecessarytosubmitcertificatesofanalysissubstantiatingtheguaranteedshelflifeonthelabel(i.e.,atthedateofmanufactureandattheexpirydate)foraminimumofthreedifferentlotsoftheproduct.Thecertificatesofanalysisforthelevel/concentrationoft

17、heactiveingredient(s)atthedateofmanufactureandattheexpirydatemustbeforthesamelotofproduct.Thestorageconditionsusedintheshelflifestudyshouldreflecttherecommendedstorageconditionsasstatedontheproductlabel.(即穩(wěn)定。如適用，資料必須提交。為了支持產(chǎn)品的穩(wěn)定性，需要提交分析證明以證明標(biāo)簽上的保質(zhì)期(即:，在生產(chǎn)日期和到期日，至少有三種不同的產(chǎn)品。在生產(chǎn)日期和到期日的有效成分的水平/濃度的分析證明必須

18、適用于相同的產(chǎn)品。貨架壽命研究中使用的存儲(chǔ)條件應(yīng)反映推薦的貯存條件。SafetyInformationAsoutlinedinsections2.3and2.4scientificinvestigationssupportingproductsafetymayinclude,butarenotlimitedto:chemicalanalysesand/orharmfulresiduesand/ortoxicologicalevaluationand/oranimalfeedingstudiesand/ortissueresidueanalysis.Thescientificstudiespre

19、sentedinsupportofproductsafetymustbe:如第2.3和2.4節(jié)所述，支持產(chǎn)品安全的科學(xué)調(diào)查可能包括但不限于:化學(xué)分析和/或有害殘留物和/或毒物學(xué)評(píng)估和/或動(dòng)物喂養(yǎng)研究和/或組織殘留分析。支持產(chǎn)品安全的科學(xué)研究必須：carriedoutbyqualifiedresearchpersonnel;由合格的研究人員進(jìn)行carriedoutusingsuitable/recognizedscientificmethodsandprotocols;文：使用適當(dāng)/認(rèn)可的科學(xué)方法和協(xié)議；designedtofacilitatestatisticalanalysis(i.e.,u

20、singasuitablestatisticalmodel,propersamplingprotocolandsufficientsamplesize);and旨在促進(jìn)統(tǒng)計(jì)分析(即使用適當(dāng)?shù)慕y(tǒng)計(jì)模型、適當(dāng)?shù)某闃臃桨负妥銐虻臉颖救萘縜nalysedusingappropriatestatisticalmethods.使用適當(dāng)?shù)慕y(tǒng)計(jì)方法進(jìn)行分析。11.Suitablemethodologiesforthedetectionofsignificantamountsofanyingredient,nutrient,compound,substance,ororganismintentionallyin

21、corporatedintothefeedoroccurringasacontaminantmustalsobeprovided.也必須提供適當(dāng)?shù)姆椒?，以檢測(cè)任何成分、營養(yǎng)素、化合物、物質(zhì)或有機(jī)體有意納入飼料中或作為污染物所產(chǎn)生的大量物質(zhì)。RequirementsforAmendments(SignificantChange)toSpecialtyProductRegistrationsApplicationsforsignificantchangewillbeevaluatedonacasebycasebasis.Changesincluding,butnotlimitedto,thefol

22、lowingproductcharacteristicsrequirethesubmissionofefficacyand/orsafetydata(whichmeetthecriteriapreviouslyoutlined),aspartoftheapplicationforregistrationamendment:changestothelabelguaranteesfornutrientsand/oractiveingredient(s);changestotheproductformulationthateffecttheefficacyand/ornutritionalconte

23、ntoftheproduct(e.g.,addition/removalofabacterialculture,changestoingredientsthatareamainsourceofnutrients,oraddition/removalofapelletbinder);changestothemanufacturingprocessthatmaychangethenatureoftheproductorcontributetotheintroductionofchemicals(eitherascontaminantsoradditives),orchangestostarting

24、materials,processingaids,etc.usedinthemanufacturingprocess;changesto,ortheadditionof,labelclaims;theadditionoflivestockspeciestotheproductlabel(i.e.,incaseswhereaproductisonlyapprovedforuseincertainspecies);modificationstothedirectionsforuse;orchangestothedurationoftheshelflifeoftheproduct.Pleaseref

25、ertoChapter1foradditionalinformationregardingsignificantchangestoproductregistrations.TheapplicationfeesforthesetypesofchangesarethesameasthoseforanewapplicationforregistrationforaCategory2product.Formulationchangesinvolvingingredientsthatarenotconsideredtobeactiveingredientsorasignificantsourceofnu

26、trients(e.g.,flavours,carriers),willbeevaluatedonacase-by-casebasisandmayormaynotrequirethesubmissionofefficacyand/orsafetydata.However,itisrecommendedthattheFeedProgrambecontactedaheadoftimeinordertodeterminewhattypeofinformationanddocumentationwillberequiredforsubmissionwiththeproposedapplicationf

27、orregistrationamendment.RegistrationRequirementsforPrivateLabelledProductsTheprivatelabelregistrationprocesshasbeenputinplacetoallowcompaniestocommercializeaproductthatisalreadyregisteredbyanothercompanyunderadifferentbrandname.Suchapplicationsareconsideredstandardfeedsanddonotrequireanyadditionalsa

28、fetyorefficacyevaluations.ApplicationsforregistrationofprivatelabelsmustincludeacompletedandsignedapplicationforApplicationforFeedRegistrationorRenewalform(CFIA/ACIA0009),theapplicationfeeforastandardmixedfeed,fivecopiesoftheproposedproductlabel(includingthenameandaddressoftheprivatelabelregistrant)

29、,anaccompanyingcoverletter,andaletterfromthecompanyholdingtheoriginalregistration,signedbyapersonhavingsigningauthorityforthiscompany,allowingtheprivatelabelapplicanttousetheinformationonfiletoregistertheirproductasaprivatelabel.Astheformulationoftheprivatelabelproductmustcorrespondexactlytotheformu

30、lationoriginallyapprovedfortheparentproduct,anymandatoryinformationpresentontheoriginallabel(e.g.,listofingredients,guaranteedanalysis,directionsforuse,cautionstatements)mustbepresentontheprivatelabel.Iftheprivatelabellingcompanyalsomanufacturesthefeed,theformulationisrequiredandcertificatesofanalys

31、ismayberequested.Applicationsforamendmentstoprivatelabelregistrationswillbeevaluatedonacase-by-casebasisaccordingtothefollowingcriteria:MandatoryamendmentsFormandatoryregistrationamendments(i.e.,amendmentsinitiatedbytheFeedProgram),theFeedProgramwillinformallholdersofaregistrationforthetypeofproduct

32、affectedbytheamendment,includingprivatelabelregistrants.Mandatoryamendmentsmustbemadetobothprivatelabelsandparentproductlabels.Therewillbenochargeforsuchamendments.Incaseswhereanapplicationismadeforaprivatelabelforwhichthestatusoftheoriginalproductregistrationwouldnotsatisfynewmandatoryrequirements(

33、duetoconcernswithefficacyand/orsafetydata),theprivatelabelapplicationwillberefuseduntiltheoriginalproductmeetsallregistrationrequirements.Theholderoftheoriginalregistrationwillbenotifiedofthesituation.MinormandatoryamendmentsrequiredbytheFeedProgramwillbemadetoaprivatelabelproductimmediatelyuponregi

34、strationorregistrationrenewal,eventhoughthelabelfortheparentproductmaynotyetcomplywiththenewamendment.Inthesecases,theprivatelabelwillbecorrectedbeforetheoriginalproductlabel.Minormandatoryamendmentstotheoriginallabelwillbemadeatthetimeofrenewalorwhenanapplicationforsignificantchangeissubmittedtothe

35、AnimalFeedDivision.VoluntaryamendmentsWhentheoriginalregistrantisgrantedanamendment(e.g.,revisedguarantee,additionofaclaim,changesintheformulation),theoriginalregistrantisresponsiblefornotifyingtheprivatelabelregistrant(s)oftheseamendments.Insuchcases,privatelabelregistrantsarenotobligedtoupdatetheirregistrationtoreflectthechange(s)madetotheoriginalregistrationaslongastheprivat