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1ENOfficialJournaloftheEuropeanCommunitiesL123/124.4.98I(Actswhosepublicationisobligatory)DIRECTIVE98/8/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof16February1998concerningtheplacingofbiocidalproductsonthemarketTHEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,HavingregardtotheTreatyestablishingtheEuropeanCommunity,andinparticularArticle100athereof,HavingregardtotheproposalfromtheCommission(1),HavingregardtotheopinionoftheEconomicandSocialCommittee(2),ActinginaccordancewiththeprocedurelaiddowninArticle189boftheTreaty(3)inthelightofthejointtextapprovedon16December1997bytheConciliationCommittee,(1)Whereas,intheirresolutionof1February1993onaCommunityprogrammeofpolicyandactioninrelationtotheenvironmentandsustainabledevelopment(4),theCouncilandtherepresentativesoftheGovernmentsoftheMemberStates,meetingwithintheCouncil,approvedthegeneralapproachandstrategyoftheprogrammepresentedbytheCommission,inwhichtheneedforriskmanagementofnon-agriculturalpesticidesisemphasised;(2)Whereas,bothwhentheeighthAmendment(5)toCouncilDirective76/769/EECof27July1976,ontheapproximationofthelaws,regulationsandadministrativeprovisionsoftheMemberStatesrelatingtorestrictionsonthemarketinganduseof(1)OJC239,3.9.1993,p.3,OJC261,6.10.1995,p.5andOJC241,20.8.1996,p.8.(2)OJC195,18.7.1994,p.70andOJC174,17.6.1996,p.32.(3)OpinionoftheEuropeanParliamentof18April1996(OJC141,13.5.1996,p.191),Councilcommonpositionof20December1996(OJC69,5.3.1997,p.13)andDecisionoftheEuropeanParliamentof13May1997(OJC167,2.6.1997,p.24).CouncilDecisionof18December1997.DecisionoftheEuropeanParliamentof14January1998.(4)OJC138,17.5.1993,p.1.(5)OJL398,30.12.1989,p.19.dangeroussubstancesandpreparations(6)wasadoptedin1989andduringthediscussionintheCouncilonDirective91/414/EECconcerningtheplacingofplantprotectionproductsonthemarket(7),theCouncilexpressedconcernatthelackofharmonisedCommunityprovisionsforbiocides,formerlyknownasnon-agriculturalpesticides,andinvitedtheCommissiontoexaminethesituationinMemberStatesandthepossibilityforactionatCommunitylevel;(3)Whereasbiocidalproductsarenecessaryforthecontroloforganismsthatareharmfultohumanoranimalhealthandforthecontroloforganismsthatcausedamagetonaturalormanufacturedproducts;whereasbiocidalproductscanposeriskstohumans,animalsandtheenvironmentinavarietyofwaysduetotheirintrinsicpropertiesandassociatedusepatterns;(4)WhereastheCommissionreviewshoweddifferencesintheregulatorysituationintheMemberStates;whereassuchdifferencesmayconstitutebarriersnotonlytotradeinbiocidalproductsbutalsototradeinproductstreatedwiththem,therebyaffectingthefunctioningoftheinternalmarket;whereas,therefore,theCommissionproposedthedevelopmentofaframeworkofrulesrelatingtotheplacingonthemarketforuseofbiocidalproducts,takingasaconditionahighlevelofprotectionforhumans,animalsandtheenvironment;whereas,havingregardtotheprincipleofsubsidiarity,decisionstakenatCommunitylevelshouldberestrictedtothosenecessaryfortheproperfunctioningofthecommonmarketandtoavoidduplicationofworkbyMemberStates;whereasadirectiveonbiocidalproductsisthemostappropriatewayofestablishingsuchaframework;(6)OJL262,27.9.1976,p.201.DirectiveaslastamendedbyDirective97/16/EC(OJL116,6.5.1997,p.31).(7)OJL230,19.8.1991,p.1.DirectiveaslastamendedbyDirective96/68/EC(OJL277,30.10.1996,p.25).1ENOfficialJournaloftheEuropeanCommunitiesL123/224.4.98(5)WhereastheframeworkofrulesshouldprovidethatbiocidalproductsshouldnotbeplacedonthemarketforuseunlesstheyhavecompliedwiththerelevantproceduresofthisDirective;(6)Whereas,totakeaccountofthespecificnatureofsomebiocidalproductsandtherisksassociatedwiththeirproposeduse,itisappropriatetoprovideforsimplifiedauthorisationprocedures,includingregistration;(7)Whereasitisappropriatethattheapplicantsubmitdossierswhichcontaininformationwhichisnecessarytoevaluatetherisksthatwillarisefromproposedusesoftheproduct;whereasacommoncoredatasetforactivesubstancesandforbiocidalproductsinwhichtheyarecontainedisnecessarysoastoassistboththeapplicantsseekingauthorisationandthosecarryingouttheevaluationtodecideontheauthorisation;whereas,furthermore,specificdatarequirementsneedtobeelaboratedforeachoftheproducttypescoveredbythisDirective;(8)Whereasitisnecessary,whenbiocidalproductsarebeingauthorised,tomakesurethat,whenproperlyusedforthepurposeintended,theyaresufficientlyeffectiveandhavenounacceptableeffectonthetargetorganismssuchasresistanceorunacceptabletolerance,and,inthecaseofvertebrateanimals,unnecessarysufferingandpain,andhave,inthelightofcurrentscientificandtechnicalknowledge,nounacceptableeffectontheenvironmentand,inparticular,onhumanoranimalhealth;(9)WhereasitisnecessarytoprovidecommonprinciplesfortheevaluationandauthorisationofbiocidalproductstoensureaharmonisedapproachbyMemberStates;(10)WhereasMemberStatesshouldnotbepreventedfromimposingadditionalrequirementsontheuseofbiocidalproductsinsofarastheseadditionalrequirementsareinconformitywithCommunitylawandinparticulardonotruncountertotheprovisionsofthisDirective;whereassuchprovisionsareintendedtoprotecttheenvironmentandhumanandanimalhealthbymeanssuc