欧盟授权维生素D3为所有物种饲料添加剂

1、欧盟授权维生素D3为所有物种的饲料增加剂COMMISSIONIMPLEMENTINGREGULATION(EU)2017/1492of21August2017concerningtheauthorisationofcholecalciferolasafeedadditiveforallanimalspecies(TextwithEEArelevance)THEEUROPEANCOMMISSION，HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion，HavingregardtoRegulation(EC)No1831/2003oft

2、heEuropeanParliamentandoftheCouncilof22September2003onadditivesforuseinanimalnutrition(1)，andinparticularArticle9(2)thereof，Whereas:(1)Regulation(EC)No1831/2003providesfortheauthorisationofadditivesforuseinanimalnutritionandforthegroundsandproceduresforgrantingsuchauthorisation.Article10ofthatRegula

3、tionprovidesforthere-evaluationofadditivesauthorisedpursuanttoCouncilDirective70/524/EEC(2).(2)CholecalciferolwasauthorisedwithoutatimelimitbyDirective70/524/EECasafeedadditiveforallanimalspecies.ThatadditivewassubsequentlyenteredintheRegisteroffeedadditivesasanexistingproduct，inaccordancewithArticl

4、e10(1)ofRegulation(EC)No1831/2003.(3)InaccordancewithArticle10(2)ofRegulation(EC)No1831/2003i1nconjunctionwithArticle7thereof，threeapplicationsweresubmittedforthere-evaluationofcholecalciferolasafeedadditiveforallanimalspeciesand，inaccordancewithArticle7ofthatRegulation，fortheuseinwaterfordrinking.T

5、heapplicantsrequestedthatadditivetobeclassifiedintheadditivecategorynutritionaladditives.ThoseapplicationswereaccompaniedbytheparticularsanddocumentsrequiredunderArticle7(3)ofRegulation(EC)No1831/2003.(4)TheEuropeanFoodSafetyAuthority(theAuthority)concludedinitsopinionsof13November2012(3)，20June2013

6、(4)，30January2014(5)and25January2017(6)that，undertheproposedconditionsofuseinfeed，cholecalciferoldoesnothaveadverseeffectsonanimalhealth，humanhealthortheenvironment.TheAuthorityfurtherconcludedthatcholecalciferolisaneffectivesourceofvitaminD3.(5)TheAuthorityconcludedinitsopinionsthatforsomeformulati

7、onsofvitaminD3thereisapotentialforworkerstobeexposedtohighlevelsofvitaminD3byinhalation.InhaledvitaminD3ishighlytoxicandexposuretodustisharmful.Consequently，appropriateprotectivemeasuresshouldbetaken.TheAuthoritydoesnotconsiderthatthereisaneedforspecificrequirementsofpos2t-marketmonitoring.Italsover

8、ifiedthereportonthemethodofanalysisofthefeedadditivesinfeedsubmittedbytheReferenceLaboratorysetupbyRegulation(EC)No1831/2003.(6)Theassessmentofcholecalciferolshowsthattheconditionsforauthorisation，asprovidedforinArticle5ofRegulation(EC)No1831/2003，aresatisfiedexceptforwaterfordrinking.Accordingly，th

9、euseofthatsubstanceshouldbeauthorisedinfeedasspecifiedintheAnnextothisRegulation.Maximumcontentsshouldbesetforcholecalciferol.Cholecalciferolshouldnotbeadministereddirectlyviawaterfordrinkingbecauseanadditionalrouteofadministrationwouldincreasetheriskforconsumersandanimals.Therefore，theauthorisation

10、ofcholecalciferolasnutritionaladditivebelongingtothefunctionalgroupvitamins，pro-vitaminsandchemicallywell-definedsubstanceshavingsimilareffectshouldbedeniedasregardstheiruseinwater.Thisprohibitiondoesnotapplytothissubstancewhenisusedwithincompoundfeedswhicharesubsequentlyadministeredviawater.(7)Sinc

11、esafetyreasonsdonotrequiretheimmediateapplicationofthemodificationstotheconditionsofauthorisationofcholecalciferolitisappropriatetoallowatransitionalperiodforinterestedpartiestopreparethemselvestomeetthenewrequirementsresultingfromtheauthorisation.3(8)ThemeasuresprovidedforinthisRegulationareinaccor

12、dancewiththeopinionoftheStandingCommitteeonPlants，Animals，FoodandFeed，HASADOPTEDTHISREGULATION:Article1AuthorisationThesubstancespecifiedintheAnnex，belongingtotheadditivecategorynutritionaladditivesandtothefunctionalgroupvitamins，provitaminsandchemicallywell-definedsubstanceshavingsimilareffect，isau

13、thorisedasafeedadditiveinanimalnutritionsubjecttotheconditionslaiddowninthatAnnex.Article2DenialAuthorisationofcholecalciferol，asanadditivebelongingtotheadditivecategorynutritionaladditivesandtothefunctionalgroupvitamins，provitaminsandchemicallywell-definedsubstanceshavingsimilareffect，isdeniedforit

14、suseinwaterfordrinking.Article3TransitionalMeasures1.ThesubstancespecifiedintheAnnexandpremixturescontai4ningthatsubstance，whichareproducedandlabelledbefore11March2018inaccordancewiththerulesapplicablebefore11September2017maycontinuetobeplacedonthemarketanduseduntiltheexistingstocksareexhausted.2.Co

15、mpoundfeedandfeedmaterialscontainingthesubstanceasspecifiedintheAnnexwhichareproducedandlabelledbefore11September2018inaccordancewiththerulesapplicablebefore11September2017maycontinuetobeplacedonthemarketanduseduntiltheexistingstocksareexhaustediftheyareintendedforfood-producinganimals.3.Compoundfee

16、dandfeedmaterialscontainingthesubstanceasspecifiedintheAnnexwhichareproducedandlabelledbefore11September2019inaccordancewiththerulesapplicablebefore11September2017maycontinuetobeplacedonthemarketanduseduntiltheexistingstocksareexhaustediftheyareintendedfornon-food-producinganimals.Article4EntryintoF

17、orceThisRegulationshallenterintoforceonthetwentiethdayfollowingthatofitspublicationintheOfficialJournaloftheEuropeanUnion.ThisRegulationshallbebindinginitsentiretyanddirectlyappli5cableinallMemberStates.DoneatBrussels，21August2017.FortheCommissionThePresidentJean-ClaudeJUNCKER(1)OJL268，p.29.(2)CouncilDirective70/524/EECof23November1970concerningadditivesinfeedingst