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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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.’
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