EU 1176根据关于植物保护产品投放市场的欧洲议会和理事会条例.docx

EU 1176根据关于植物保护产品投放市场的欧洲议会和理事会条例.docx

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EU1176根据关于植物保护产品投放市场的欧洲议会和理事会条例

（EU）2015/1176：

根据关于植物保护产品投放市场的欧洲议会和理事会条例

　　THEEUROPEANCOMMISSION,

　　HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion,

　　HavingregardtoRegulation（EC）No1107/2016oftheEuropeanParliamentandoftheCouncilof21October2016concerningtheplacingofplantprotectionproductsonthemarketandrepealingCouncilDirectives79/117/EECand91/414/EEC

（1）,andinparticularArticle22

（1）inconjunctionwithArticle13

（2）thereof,

　　Whereas:

（1）

　　InaccordancewithArticle7

（1）ofRegulation（EC）No1107/2016Belgiumreceivedon30July2016anapplicationfromDeCeusterNVfortheapprovaloftheactivesubstancePepinomosaicvirusstrainCH2isolate1906.InaccordancewithArticle9（3）ofthatRegulation,Belgium,asrapporteurMemberState,notifiedtheCommissionon10January2016oftheadmissibilityoftheapplication.

（2）

　　On8January2016therapporteurMemberStatesubmittedadraftassessmentreporttotheCommissionwithacopytotheEuropeanFoodSafetyAuthority（hereinafter‘theAuthority’）,assessingwhetherthatactivesubstancecanbeexpectedtomeettheapprovalcriteriaprovidedforinArticle4ofRegulation（EC）No1107/2016.

　　（3）

　　TheAuthoritycompliedwithArticle12

（1）ofRegulation（EC）No1107/2016.InaccordancewithArticle12（3）ofRegulation（EC）No1107/2016,itrequestedthattheapplicantsupplyadditionalinformationtotheMemberStates,theCommissionandtheAuthority.TheassessmentoftheadditionalinformationbytherapporteurMemberStatewassubmittedtotheAuthorityintheformatofanupdateddraftassessmentreportinOctober2016.

　　（4）

　　On19December2016theAuthoritycommunicatedtotheapplicant,theMemberStatesandtheCommissionitsconclusiononwhethertheactivesubstancePepinomosaicvirusstrainCH2isolate1906canbeexpectedtomeettheapprovalcriteriaprovidedforinArticle4ofRegulation（EC）No1107/2016

（2）.TheAuthoritymadeitsconclusionavailabletothepublic.

　　（5）

　　On20March2016theCommissionpresentedtotheStandingCommitteeonPlants,Animals,FoodandFeedthereviewreportforPepinomosaicvirusstrainCH2isolate1906andadraftRegulationprovidingthatPepinomosaicvirusstrainCH2isolate1906isapproved.

　　（6）

　　Theapplicantwasgiventhepossibilitytosubmitcommentsonthereviewreport.

　　（7）

　　Ithasbeenestablishedwithrespecttooneormorerepresentativeusesofatleastoneplantprotectionproductcontainingtheactivesubstance,andinparticulartheuseswhichwereexaminedanddetailedinthereviewreport,thattheapprovalcriteriaprovidedforinArticle4ofRegulation（EC）No1107/2016aresatisfied.Thoseapprovalcriteriaarethereforedeemedtobesatisfied.ItisthereforeappropriatetoapprovePepinomosaicvirusstrainCH2isolate1906.

　　（8）

　　InaccordancewithArticle13

（2）ofRegulation（EC）No1107/2016inconjunctionwithArticle6thereofandinthelightofcurrentscientificandtechnicalknowledge,itis,however,necessarytoincludecertainconditionsandrestrictions.

　　（9）

　　TheCommissionfurtherconsidersthatPepinomosaicvirusstrainCH2isolate1906isalow-riskactivesubstancepursuanttoArticle22ofRegulation（EC）No1107/2016.PepinomosaicvirusstrainCH2isolate1906isnotasubstanceofconcernandfulfilstheconditionssetinpoint5ofAnnexIItoRegulation（EC）No1107/2016.PepinomosaicvirusstrainCH2isolate1906isanaturallyoccurringplantvirusstrain.Aplantvirusdoesnotreplicateoutsidetheplantcellandthevirusdoesnothaveacellularstructureanddoesnotproducemetabolites.Itisnotpathogenictohumansoranimals.Theadditionalexposureofhumans,animalsandtheenvironmentbytheusesapprovedunderRegulation（EC）No1107/2016isexpectedtobenegligiblecomparedtoexposureexpectedthroughrealisticnaturalsituations.

　　（10）

　　ItisthereforeappropriatetoapprovePepinomosaicvirusstrainCH2isolate1906asalow-risksubstance.InaccordancewithArticle13（4）ofRegulation（EC）No1107/2016,theAnnextoCommissionImplementingRegulation（EU）No540/2016（3）shouldbeamendedaccordingly.

　　（11）

　　ThemeasuresprovidedforinthisRegulationareinaccordancewiththeopinionoftheStandingCommitteeonPlants,Animals,FoodandFeed,

　　HASADOPTEDTHISREGULATION:

　　Article1

　　Approvalofactivesubstance

　　TheactivesubstancePepinomosaicvirusstrainCH2isolate1906,asspecifiedinAnnexI,isapprovedsubjecttotheconditionslaiddowninthatAnnex.

　　Article2

　　AmendmentstoImplementingRegulation（EU）No540/2016

　　TheAnnextoImplementingRegulation（EU）No540/2016isamendedinaccordancewithAnnexIItothisRegulation.

　　Article3

　　Entryintoforce

　　ThisRegulationshallenterintoforceonthetwentiethdayfollowingthatofitspublicationintheOfficialJournaloftheEuropeanUnion.

　　ThisRegulationshallbebindinginitsentiretyanddirectlyapplicableinallMemberStates.

　　DoneatBrussels,17July2016.

　　FortheCommission

　　ThePresident

　　Jean-ClaudeJUNCKER

（1）OJL309,,p.1.

（2）EFSAJournal2016;13

（1）:

3977Availableonline:

　　（3）CommissionImplementingRegulation（EU）No540/2016of25May2016implementingRegulation（EC）No1107/2016oftheEuropeanParliamentandoftheCouncilasregardsthelistofapprovedactivesubstances（OJL153,,p.1）.

　　ANNEXI

　　CommonName,IdentificationNumbers

　　IUPACName

　　Purity

（1）

　　Dateofapproval

　　Expirationofapproval

　　Specificprovisions

　　PepinomosaicvirusstrainCH2isolate1906

　　GenBank,accessionnumberJN835466

　　CIPACNo:

notallocated

　　Notapplicable

　　minimumconcentration5×105viralgenomecopiesperμL

　　7August2016

　　7August2030

　　Onlytheuseingreenhousesmaybeauthorised.

　　FortheimplementationoftheuniformprinciplesasreferredtoinArticle29（6）ofRegulation（EC）No1107/2016,theconclusionsofthereviewreportonPepinomosaicvirusstrainCH2isolate1906,andinparticularAppendicesIandIIthereof,shallbetakenintoaccount.

　　InthisoverallassessmentMemberStatesshallpayparticularattentiontotheprotectionofoperatorsandworkers,takingintoaccountthatPepinomosaicvirusstrainCH2isolate1906istobeconsideredasapotentialsensitiser.Conditionsofuseshallincluderiskmitigationmeasures,whereappropriate.

　　Strictmaintenanceofenvironmentalconditionsandqualitycontrolanalysisduringthemanufacturingprocessshallbebeassuredbytheproducer.

（1）Furtherdetailsonidentityandspecificationofactivesubstanceareprovidedinthereviewreport.

　　ANNEXII

　　InPartDoftheAnnextoImplementingRegulation（EU）No540/2016,thefollowingentryisadded:

　　CommonName,IdentificationNumbers

　　IUPACName

　　Purity

（1）

　　Dateofapproval

　　Expirationofapproval

　　Specificprovisions

　　‘4

　　PepinomosaicvirusstrainCH2isolate1906

　　GenBank,accessionnumberJN835466

　　CIPACNo:

notallocated

　　Notapplicable

　　minimumconcentration5×105viralgenomecopiesperμL

　　7August2016

　　7August2030

　　Onlytheuseingreenhousesmaybeauthorised.

　　FortheimplementationoftheuniformprinciplesasreferredtoinArticle29（6）ofRegulation（EC）No1107/2016,theconclusionsofthereviewreportonPepinomosaicvirusstrainCH2isolate1906,andinparticularAppendicesIandIIthereof,shallbetakenintoaccount.

　　InthisoverallassessmentMemberStatesshallpayparticularattentiontotheprotectionofoperatorsandworkers,takingintoaccountthatPepinomosaicvirusstrainCH2isolate1906istobeconsideredasapotentialsensitiser.Conditionsofuseshallincluderiskmitigationmeasures,whereappropriate.

　　Strictmaintenanceofenvironmentalconditionsandqualitycontrolanalysisduringthemanufacturingprocessshallbeassuredbytheproducer.’