3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/3
ii
(PreparatoryActs)
COMMISSION
ProposalforaCouncilDirectiveconcerningtheplacingofbiocidalproductsonthemarket
(93/C239/03)
COM(93)351final—SYN465
(SubmittedbytheCommissionon27July1993)
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,CommissiontoexaminethesituationinMemberStates
andthepossibilityforactionatCommunitylevel;
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity,andinparticularArticle100a
thereof,Whereastheterm'non-agricultural pesticides'was
formerlyusedtomakeadistinctionwithplantprotection
productswhichareessentiallyagriculturalpesticides;
whereas,however,biocidalproductisnowamore
accurateandappropriatetermtodescribetheproducts
coveredbythisDirective;HavingregardtotheproposalfromtheCommission,
IncooperationwiththeEuropeanParliament,
HavingregardtotheopinionoftheEconomicand
SocialCommittee,Whereasbiocidalproductscompriseahighlydiverse
groupofproducts,includingwoodpreservatives,roden­
ticides,insecticides,anti-foulings,surfaceandwater
biocides,disinfectants,fumigants,preservativesfor
technicalandhouseholdmaterials,preservativesfor
worksofart,andothers;whereastheycangiveriseto
exposureofmanandtheenvironmentinagreatvariety
ofways;
Whereasprovisionsrelatingtocertaindangerous
substancesandpreparationshavealreadybeenlaiddown
inCommunitydirectives;whereasitisstillnecessaryto
establishrulesinrespectofotherproductswhichcontain
dangeroussubstancesandwhichmayinvolverisksfor
manandtheenvironment ;Whereasbiocidalproductsarenecessaryforcontrolof
organismsthatareharmfultohumanoranimalhealth
andforthecontroloforganismsthatcausedamageto
naturalormanufacturedproducts;
Whereas,in1989,atthetimeoftheadoptionofthe
eighthAmendment(l)toCouncilDirective
76/769/EEC(2)onthemarketinganduseofcertain
dangeroussubstancesandpreparations,theCouncil
invitedtheCommissiontodevelopspecificmeasuresfor
Communityactioninthefieldofnon-agricultural
pesticides;WhereastheCommissionreviewshowedadiverseregu­
latorystatusintheMemberStates;whereasthereare
rulesinafewoftheMemberStatesgoverningthe
placingonthemarketforuseofbiocidalproductsand
whereastheserulesdifferastotheconditionsforsuch
placingonthemarketandwhereassuchdifferencesmay
constitutenotonlybarrierstotradeinbiocidalproducts
butalsototradeinproductstreatedwiththem,thereby
affectingthefunctioningoftheinternalmarket;
WhereasduringthediscussionintheCouncilon
Directive91/414/EEC(3),theCouncilexpressed
concernatthelackofharmonizedCommunity
provisionsfornon-agricultural pesticidesandinvitedtheWhereasinconsequencetheCommissionconcluded
therewasaneedforactionatCommunitylevelto
eliminatesuchbarriersbyharmonizingtherulesrelating
totheplacingonthemarketforuseofbiocidalproducts,
takingasaconditionahighlevelofprotectionforman
andtheenvironment ;(')OJNoL398,30.12.1989,p.19.
OOJNoL262,27.9.1976,p.201.
(3)OJNoL230,19.8.1991,p.1.

NoC239/4 OfficialJournaloftheEuropeanCommunities 3.9.93
Whereasinthelightofthediversityofboththe
substancesandproductsconcerned,thetestrequirements
shouldallowforsomeflexibilitytosuittheindividual
circumstances andshouldresultinanoverallrisk
assessment ;Whereastherefore,theCommissionmadeastatement
towardstheCouncilproposingthedevelopmentofa
frameworkofrules;whereas,havingregardtothe
principleofsubsidiarity,decisionstakenatCommunity
levelshouldberestrictedtothosenecessaryforthe
properfunctioningofthecommonmarketandtoavoid
duplicationofworkbyMemberStatestakinginto
accountthenecessitytoensureahighdegreeof
protectionformanandtheenvironmentthroughoutthe
Communityandwhereasadirectiveonbiocidalproducts
(non-agricultural pesticides)isthemostappropriateway
ofestablishingsuchaframework;Whereasitisintheinterestoffreecirculationofbiocidal
productsaswellasofgoodstreatedwiththem,that
authorizationgrantedbyoneMemberState,andtests
carriedoutwithaviewtoauthorization ,shouldbe
recognizedbyotherMemberStates;
Whereassuchrulesshouldprovidethatbiocidalproducts
shouldnotbeplacedonthemarketforuseunlessthey
havebeenofficiallyauthorized;Whereasitisthereforedesirablethatasystemforthe
mutualexchangeofinformationshouldbeestablished
andthatMemberStatesandtheCommission should
makeavailabletoeachotheronrequesttheparticulars
andscientificdocumentation submittedinconnection
withapplicationsforauthorizationofbiocidalproducts;Whereassuchofficialauthorization isappropriateas
biocidalproductsconsistmostlyofdangeroussubstances
andarepreparationsdesignedtohavedetrimentaleffects
ontheorganismstheyareintendedtocontrol;whereas
biocidalproductsmayhaveconsequencesotherthanthe
intendedeffectsonthetargetspecies,theyweredesigned
forandwhereas,therefore,theymayespeciallyinvolve
risksformanandtheenvironment ;Whereas,MemberStatesmustbeabletoauthorize
biocidalproductsnotcomplyingwiththeabovemen­
tionedconditionsforalimitedperiodoftime,especially
incaseofanunforeseendangerthreateningmanorthe
environmentwhichcannotbecontainedbyothermeans;
whereassuchauthorizationshouldbereviewedbythe
CommissioninclosecooperationwiththeMember
States;whereastheCommunityprocedureshouldnot
preventMemberStatesfromauthorizingforuseintheir
territoryforalimitedperiodoftimebiocidalproducts
containinganactivesubstancenotyetenteredinthe
Communitylist,providedthatadossiermeeting
Communityrequirementshasbeensubmittedandthe
MemberStatebelievesthattheactivesubstanceandthe
biocidalproductssatisfytheCommunityconditionssetin
regardtothem;Whereasitisappropriatethatanapplicantshouldsubmit
dossiersandwhereasitisfurtherappropriatethatthe
dossiersshallcontainonlythatinformationwhichis
necessarytoevaluatetherisksthatwillarisefrom
proposedusesoftheproduct;
Whereasitisnecessary,atthetimewhenbiocidal
productsareauthorized,tomakesurethat,when
properlyusedforthepurposeintended,theyaresuffi­
cientlyeffectiveandhavenounacceptableeffectontheir
targetspecies(i.e.theydonotcauseundesirable
resistanceandinthecaseofvertebrateanimals
unnecessarysuffering),andhaveinthelightofcurrent
scientificandtechnicalknowledgenounacceptable
adverseinfluenceontheenvironmentand,inparticular,
noharmfuleffectonhumanoranimalhealth;Whereasactivesubstancesusedinbiocidalproductsmay
alsobeusedinotherpreparationswhichhaveunder
otherCommunitylegislation,beentestedonanimals;
whereasdoubletestingonanimalsmustbeavoided;
whereas,closecoordination shouldbeensuredwith
otherCommunitylegislationandinparticularwith
Directive91/414/EEContheplacingonthemarketof
plantprotectionproducts;
Whereasauthorization shouldbelimitedtobiocidal
productscontainingcertainactivesubstancesevaluated
onthebasisoftheirphysicochemical ,toxicologicaland
ecotoxicological properties;Whereas,inordertoensurethattherequirementslaid
downinrespectofauthorizedbiocidalproductsare
satisfiedwhentheyareplacedonthemarket,Member
Statesmustmakeprovisionforappropriatecontroland
inspectionarrangements ;
WhereasitisnecessarytoestablishaCommunitylistof
activesubstancespermittedforinclusioninbiocidal
products;whereasaCommunityproceduremustbelaid
downforassessingwhetherornotanactivesubstance
canbeenteredintheCommunitylist;whereastheinfor­
mationthatinterestedpartiesmustsubmitwithaviewto
admissionofasubstancetothelisthastobespecified;
whereas,intheinterestofsafety,substancesonthelist
shouldbereviewedperiodically,totakeaccountof
developments inscienceandtechnology;Whereastheimplementation ofthisDirective,theadap­
tationofitsAnnexestothedevelopmentoftechnicaland
scientificknowledge,andtheregistrationof
Community-approved activesubstancesnecessitateclose
cooperationbetweentheCommissionandtheMember
Statesandtheapplicant;whereastheprocedureofthe
StandingCommitteeonBiocidalProductsoffersa
suitablebasisforthiscooperation ;whereasthisentails
transparencyoftheadministrativeprocedures;
/

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/5
Whereasthefullimplementation ofthisDirectiveand
especiallyofArticle14(4)willnotbeachievedfor
severalyears,Directive76/769/EEContheapproxi­
mationofthelaws,regulationsandadministrative
provisionsoftheMemberStatesrelatingtorestrictions
onthemarketinganduseofcertaindangerous
substancesandpreparationscanprovideforaframework
tocomplementthedevelopmentofthepositivelistby
limitationsofthemarketinganduseofcertainactive
substancesandproductsorgroupsofthese;law,regulationoradministrativeactionrelatingto
proprietarymedicinalproducts(2);
(b)CouncilDirectives 70/524/EEC(J)and
82/471/EEC(4)onadditivesandsubstancesfor
exclusiveuseinanimalfeedingstuffs;
(c)CouncilDirective76/768/EEC(5)oncosmetic
products;
(d)CouncilDirective89/107/EECof21December
1988onsubstancesusedexclusivelyasadditivesto
foodstuffs(6)andCouncilDirective88/388/EECof
22June1988onsubstancesusedexclusivelyas
flavouringsinfoodstuffs(7);
i
(e)CouncilDirective91/414/EECof15July1991
concerningtheplacingofplantprotectionproducts
onthemarket(8);
(f)CouncilDirective.../.../EECconcerningmedical
devices.WhereastheCouncilinitsresolutionof1February
1993(')onaCommunityprogrammeofpolicyand
actioninrelationtotheenvironment andsustainable
developmenthasapprovedthegeneralapproachand
strategyoftheprogrammepresentedbytheCommission
whichstatesthateconomicgrowthandenvironmental
qualitymustbeviewedasmutuallydependant;whereas
thereforethestrengtheningofenvironmental protection
requiresthemaintenanceoftheeconomiccompeti­
tivenessofindustry;
Whereasthereviewofactivesubstancesshallneedto
takeaccountofotherworkprogrammeswithinthe
frameworkofotherCommunitylegislationsconcerned
withtherevieworauthorization ofsubstancesand
products;
Whereasminimumrulesconcerningtheuseofbiocidal­
productsatworkarealreadylaiddownunderdirectives
onhealthandsafetyatwork:whereasitisdesirableto
developfurthertheserules;
HASADOPTEDTHISDIRECTIVE :3.ThisDirectiveshallapplywithoutprejudicetothe
provisionsof:
(a)CouncilDirective76/769/EECof27July1976on
theapproximation ofthelaws,regulationsand
administrative provisionsoftheMemberStates
relatingtorestrictionsonthemarketinganduseof
certaindangeroussubstancesandpreparations ;
(b)CouncilDirective79/117/EECof21December
1978prohibitingtheplacingonthemarketanduse
ofplantprotectionproductscontainingcertainactive
substances(');
(c)CouncilRegulation(EEC)No1734/88of16June
1988ontheexportfromandimportintothe
Communityofcertaindangerouschemicals(10);
(d)CouncilDirective80/1107/EECof27November
1980ontheprotectionofworkersagainstdangers
fromexposuretochemical,physicalandbiological
agentsatwork("),andCouncilDirective
89/391/EECof12July1989ontheintroductionof
measurestoencourageimprovements inthesafety
andhealthofworkersatwork(12)andindividual
DirectivesbasedontheseDirectives;Article1
Scopeofapplicability
1.ThisDirectiveconcerns
(a)theauthorizationandtheplacingonthemarketfor
useofbiocidalproductswithintheMemberStates;
(b)themutualacceptanceofauthorizations withinthe
Community ;
levelofapositive
maybeusedin(c)theestablishmentatCommunity
listofactivesubstanceswhich
biocidalproducts.
2.ThisDirectiveshallapplytobiocidalproductsas
definedinArticle2(1)(a)butshallexcludeproducts
wheretheyarecoveredbythefollowingDirectivesfor
thepurposesoftheseDirectives:OOJNo
OOJNo
OOJNo
OOJNo
(6)OJNo
OOJNo
(•)OJNo
OOJNo
(10)OJNo
(")OJNo
(")OJNo22,9.2.1965,p.369/65.
L270,14.12.1970,p.1.
L213,21.7.1982,p.8.
L262,27.9.1976,p.169
L40,12.2.1989,p.27.
L184,15.7.1988,p.61.
L230,19.8.1991,p.1.
L33,8.2.1979,p.36.
L155,22.6.1988,p.2.
L327,3.12.1980,p.8.
L183,29.6.1989,p.1.r
(a)CouncilDirective65/65/EECof26January1965
ontheapproximation ofprovisionslaiddownby
OOJNoC138,17.5.1993,p.1.

NoC239/6 OfficialJournaloftheEuropeanCommunities 3.9.93
(e)CouncilDirective90/679/EECof26November
1990ontheprotectionofworkersfromrisksrelated
toexposuretobiologicalagentsatwork(seventh
individualDirectivewithinthemeaningofArticle16
(1)ofDirective89/391/EEC)(').2.ForthepurposesofthisDirectivethedefinitions
for
(a)substances;
(b)preparations;
(c)scientificresearchanddevelopment ;
(d)process-orientated researchanddevelopment
laiddowninArticle2ofDirective67/548/EEConthe
classification,packagingandlabellingofdangerous
substances(2)shallapply.4.Article18doesnotapplytothecarriageofbiocidal
productsbyrail,road,inlandwaterway,seaorair.
Article2
Definitions
1.ForthepurposesofthisDirectivethefollowing
definitionsshallapply:Article3
Authorizationforplacingonthemarketofbiocidal
products
1.MemberStatesshallprescribethatabiocidal
productshallnotbeplacedonthemarketandusedin
theirterritoryunlessithasbeenauthorizedin
accordancewiththisDirective.
2,Everyapplicationforauthorizationshallbedecided
uponwithinaresonableperiod.
3.Abiocidalproductthathasalreadybeenauthorized
inoneMemberStateshallbeauthorized,inanother
MemberStatewithin60daysofanapplicationbeing
receivedbytheotherMemberState,providingthatthe
activesubstanceofthebiocidalproductconformstothe
entryinAnnexI.V
(a)biocidalproducts:
activesubstancesandpreparationscontainingoneor
moreactivesubstances,putupintheforminwhich
theyaresuppliedtotheuser,intendedtodestroy,
deter,renderharmless,preventtheactionof,or
otherwiseexertacontrollingeffectonanyharmful
organism.
AnindicativelistofproducttypesisatAnnexV;
(b)activesubstances
substances,fungiandmicro-organisms including
viruseshavinggeneralorspecificactiononor
againstharmfulorganisms;
(c)harmfulorganism
anyorganismwhichhasanunwantedpresenceora
detrimentaleffectforman,hisactivitiesorthe
productsheusesorproduces,orforanimalsorfor
theenvironment ;
(d)placingonthemarket
anysupply,whetherinreturnforpaymentorfreeof
charge,otherthanforstoragefollowedby
consignmentfromtheterritoryoftheCommunityor
disposal.Importationofabiocidalproductintothe
territoryoftheCommunityshallbedeemedto
constituteplacingonthemarketforthepurposesof
thisDirective;
(e)authorization
administrativeactbywhichthecompetentauthority
ofaMemberStateauthorizes,followingan
applicationsubmittedbyanapplicant,theplacingon
themarketofabiocidalproductinitsterritoryorin
apartthereof;
(f)residues
Oneormoreofthesubstancespresentinabiocidal
productwhichremainsasaresultofitsuseincluding
themetabolitesofsuchsubstancesandproducts
resultingfromtheirdegradationorreaction.4.IfincomplyingwithArticle4aMemberState
establishesthat:
(a)unacceptableresistanceofthetargetorganismtothe
biocidalproductisprovenor
(b)therelevantcircumstancesofuse,suchasclimateor
breedingperiodofthetargetspecies,differsignifi­
cantlyfromthoseintheMemberStatewherethe
biocidalproductwasfirstauthorized,andan
unchangedauthorization maythereforepresent
unacceptableriskstomanortheenvironment,
theMemberStatemayrequestthatthedirectionsforuse
andthedoseratereferredtoinArticle18(3)(e)are
adjustedtothedifferentcircumstances ,or,iftheriskcan
notbepreventedinanyotherway,theMemberState
mayrequestchangestobemadetothebiocidalproduct
itselfsothatconditionsforissueofanauthorization
providedforinArticle4aresatisfied.
5.Notwithstanding paragraph4whereaMember
Statebelievesabiocidalproductcannotmeetthe
conditionssetoutunderArticle4andconsequently
proposestorefuseauthorization ,itshallnotifythe
Commission ,otherMemberStatesandtheapplicantand
(')OJNoL374,31.12.1990,p.1. ()OJNoL196,16.8.1967,p.1(asamended).

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/7
shallprovidethemwithanexplanatorydocumentgiving
detailsoftheproductandsettingoutthegroundson
whichitproposestorefusetheauthorization .
TheCommissionshallprepareaproposalonthese
mattersinaccordancewithArticle24fordecisionin
accordancewiththeprocedurelaiddowninArticle25—theconsequencesfromuseanddisposal,
thebiocidalproduct:
(i)issufficientlyeffective;
(ii)hasnounacceptableeffectonthetarget
organism;
(iii)hasnoharmfuleffectsitselforasaresultofits
residues,onhumanoranimalhealth,directlyor
indirectly(e.g.throughdrinkingwater,foodor
feed)orongroundwater ;(3­
6.MemberStatesshallprescribethatbiocidal
productsshallbeclassified,packagedandlabelledin
accordancewiththeprovisionsofthisDirective.
7.Authorizations shallbegrantedforafixedperiod
of10yearsfromthedateoffirstentryoftheactive
substanceontoAnnexI;theymayberenewedafterveri­
ficationthattheconditionsimposedinparagraphs 1and
2arestillsatisfied.Renewalmay,wherenecessary,be
grantedonlyfortheperiodnecessarytoallowthe
competentauthoritiesoftheMemberStates,tomake
suchverification,whereanapplicationforrenewalhas
beenmade.
8.MemberStatesshallprescribethatbiocidalproduct
mustbeproperlyused.Properuseshallinclude
compliancewithconditionsestablishedunderArticle4
andspecifiedunderthelabellingprovisionsofthis
Directive.Properuseshallalsoinvolvetherational
applicationofacombinationofphysical,biological,
chemicalorothermeasuresasappropriatewherebythe
useofbiocidalproductsislimitedtotheminimum
necessary.Wherebiocidalproductsareusedatworkuse
shallalsobeinaccordancewiththerequirementsof
directivesfortheprotectionofworkers.(iv)hasnounacceptableeffectsontheenvironment
havingparticularregardtothefollowing
considerations :
—itsfateanddistributionintheenvironment ;
particularly contamination ofwater
includingdrinkingwaterandgroundwater,
—itsimpactonnon-targetorganisms;
(v)doesnotcauseunnecessarysufferingandpain
tovertebratestobecontrolled;
(c)thenatureandquantityofitsactivesubstancesand,
whereappropriate,anytoxicologicallyorecotoxico­
logicallysignificantimpuritiesandco-formulants ,
anditsresiduesoftoxicologicalorenvironmental
significance,whichresultfromauthorizeduses,can
bederminedaccordingtotherelevantrequirements
inAnnexesII,IIIandIV;
(d)itsphysicalandchemicalpropertieshavebeen
derterminedanddeemedacceptableforpurposesof
theappropriateuse,storageandtransportofthe
product.
2.AbiocidalproductclassifiedaccordingtoArticle18
(1)asverytoxicorasacategory1or2qarcinogen,or
mutagenorclassifiedastoxicforreproductioncategory
1or2,shallnotbeauthorizedformarketingto,oruse
bythegeneralpublic.
3.Authorization maybeconditionalonrequirements
relatingtomarketingandusenecessarytoensure
compliancewiththeprovisionsofparagraph 1.
t
4.WhereotherCommunityprovisionsimpose
requirementsrelevanttotheconditionsfortheissueof
anauthorization andparticularlywheretheseare
intendedtoprotectthehealthofdistributors,users,
workersandconsumersoranimalhealthofdistributors,
users,workersandconsumersoranimalhealthorthe
environment,thecompetentauthorityshalltakethese
intoaccountwhenissuinganauthorizationandwhere
necessaryshallissuetheauthorizationsubjecttothose
requirements .Article4
Conditionsforissueofanauthorization
1.MemberStatesshallauthorizeabiocidalproduct
onlyif
(a)theactivesubstance(s)includedthereinarelistedin
AnnexIandanyconditionslaiddownintheAnnex
arefulfilled;
(b)itisestablished,inthelightofcurrentscientificand
technicalknowledgeanditisshownfromappraisal
ofthedossierprovidedforinAnnexIIIand,where
specified,therelevantpartsofAnnexIVaccording
tothecommonprinciplesfortheevaluationof
dossiers,thatwhenusedasauthorizedandhaving
regardto:
—allnormalconditionsunderwhichthebiocidal
productmaybeused,
—howthematerialtreatedwithitmaybeused,

NoC239/8 OfficialJournaloftheEuropeanCommunities 3.9.93
Article5
Reviewofanauthorizationtheproposedchanges,inaccordancewiththeprocedures
laiddowninArticle10.
8.Modificationshallonlybegrantedifitisestab­
lishedthattheconditionsunderArticle4continuetobe
satisfied.Authorizationmaybereviewedatanytimeifthereare
indicationsthatanyoftherequirementsreferredtoin
Article4arenolongersatisfied.Insuchinstancesthe
MemberStatesmayrequiretheapplicantforauthori­
zationortheapplicanttowhomamodificationofauth­
orizationhasbeengrantedinaccordancewithArticle6
tosubmitfurtherinformationnecessaryforthereview.
Renewalmay,wherenecessary,begrantedonlyforthe
periodnecessarytocompleteareview,andshallbe
grantedfortheperiodnecessarytoprovidesuchfurther
information .Article7
Requirementsforauthorization
1.Applicationforauthorizationshallbemadebyor
onbehalfofthepersonwhowillberesponsibleforthe
firstplacingonthemarktetofabiocidalproductina
particularMemberStateandshallbetothecompetent
authorityofthatMemberState.Everyapplicantshallbe
requiredtohaveapermanentofficewithinthe
Community .Article6
Cancellationormodification ofanauthorization
1.Anauthorization shallbecancelledif:
(a)theactivesubstanceisnolongerincludedinAn­
nexI;
(b)theconditionsunderArticle4(1)forobtainingthe
authorizationarenolongersatisfied;
(c)itisdiscoveredthatfalseormisleadingparticulars
weresuppliedconcerningthefactsonthebasisof
whichtheauthorizationwasgranted.2.MemberStatesshallrequirethatapplicantsfor
authorizationofabiocidalproductshallsubmittothe
competentauthority:
(a)adossieronthebiocidalproductsatisfying,inthe
lightofcurrentscientificandtechnicalknowledge,
therequirementssetoutinAnnexIIIand,where
specified,therelevantpartsofAnnexIX;and
I
(b)foreachactivesubstanceinthebiocidalproduct,a
dossiersatisfying,inthelightofcurrentscientific
andtechnicalknowledge,therequirementssetoutin
AnnexIIand,wherespecified,therelevantpartsof
AnnexIV.2.Anauthorizationmayalsobecancellediftheauth­
orizationholderrequestsitandstatesthereasonsforthe
cancellation .
3.WhereaMemberStatecancelsanauthorization ,it
shallinformtheauthorizationholderanditmaygranta
periodofgraceforthedisposalorforstorage,marketing
anduseofexistingstocks,ofalengthinaccordancewith
thereasonforthecancellationwithoutprejudicetoany
periodprovidedforbydecisiontakenunderDirective
76/769/EECorinconnectionwithparagraph 1(a).3.Thedossiersshallincludeadetailedandfull
decriptionofthestudiesconductedandofthemethods
usedorabibliographical referencetothosemethods.
Theinformationinthedossierssuppliedaccordingto
Article7(2)shallbesufficientforanevaluationtobe
madeoftheeffectsandpropertiesreferredtoinArticle4
(1)(b),(c)and(d).Itshallbesubmittedtothe
competentauthorityintheformoftechnicaldossiers,
containingtheinformationandresultsofthestudies
referredtoinAnnexIIandAnnexIIIand,where
specified,therelevantpartsofAnnexIV.4.Anauthorization shallbemodifiedif,onthebasis
ofdevelopments inscientificandtechnicalknowledge,
theconditionsofuseand,inparticular,mannerofuseor
amountsusedcanbemodified.
5.Anauthorizationmayalsobemodifiediftheauth­
orizationholderrequestsitandstatesthereasonsforthe
modification .4.Information,whichisnotnecessaryowingtothe
natureofthebiocidalproductorofitsproposeduses
neednotbesupplied.Thesameapplieswhereitisnot
scientificallynecessaryortechnicallypossibletosupply
theinformation .Insuchcases,ajustification,acceptable
tothecompetentauthoritymustbesubmitted.6.Whereaproposedmodification concernsan
extentionofuses,MemberStatesshallextendtheauth­
orizationsubjecttotheparticularconditionsplacedon
theactivesubstanceinAnnexI.
7.Whereaproposedmodificationofanauthorization
involveschangestotheparticularconditionsplacedon
theactivesubstanceinAnnexI,thesecanbemadeonly
afterevaluationoftheactivesubstance,withregardto5.Iftheevaluationofthedossiershowsthatfurther
informationincludinginformationandresultsfrom
furthertestingisnecessarytoevaluatetherisksofthe
biocidalproduct,thecompetentauthorityshallaskthe
applicanttosubmitsuchinformation .

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/9
6.Thenameofanactivesubstancemustbegivenas
registeredinthelistcontainedinAnnexItoDirective
67/548/EECor,ifnotincludedtherein,asgiveninthe
EuropeanInventoryofExistingChemicalSubstances
(Einecs)(x),orifnotincludedtherein,itmustbegiven
itsInternationalStandardsOrganization (ISO)common
name.Ifthelatterisnotavailable,thesubstancemustbe
designatedbyitschemicaldesignationaccordingto
IUPACrules.adossierhasbeenforwardedtoaMemberState,
whichsatisfiestherequirementsofArticle10(1),
andisaccompaniedbythedeclarationthattheactive
substanceisintendedforinclusioninabiocidal
product.Thisshallnotapplytosubstancesforuse
underArticle15;
(b)itisclassified,packagedandlabelledinaccordance
withtheprovisionsofDirective67/548/EEC.
Article9
InclusionofanactivesubstanceinAnnexI
1.Inthelightofcurrentsientificandtechnical
knowledge,anactivesubstanceshallbeincludedin
AnnexIforaninitialperiodnotexceeding10yearsifit
maybeexpectedthatbiocidalproductscontainingthe
acitvesubstancewillfulfiltheconditionslaiddownin
Article4(1)(b),(c)and(d).7.Testsmustbeconductedaccordingtothemethods
describedinAnnexVofDirective67/548/EEC.Inthe
eventofamethodbeinginappropriateornotdescirbed,
othermethodsusedshould,wheneverpossible,beinter­
nationallyrecognizedandmustbejustified.Testsmust
beconductedinaccordancewiththeprovisionslaid
downinDirective86/609/EEContheprotectionof
animalsusedforexperimentalandotherscientific
purposesandCouncilDirective87/18/ECC(2)of18
December1986ontheharmonization oflaws,regu­
lationsandadministrative provisionsfortheapplication
oftheprinciplesofGoodLaboratoryPracticeandthe
verificationoftheirapplicationsfortestsonchemical
substances .
8.CompetentauthoritiesasreferredtounderArticle
23shallensurethatafileiscompliedoneach
application .Eachfileshallcontainatleastacopyofthe
application,arecordoftheadministrative decisions
takenbytheMemberStateconcerningtheapplication
andconcerningthedossierssubmittedinaccordance
withparagraph2togetherwithasummaryofthelatter.
MemberStatesshallonrequestmakeavailabletothe
othercompetentauthoritiesandtotheCommissionthe
filesprovidedforinthisparagraph;theyshallsupplyto
themonrequestallinformationnecessaryforfull
comprehension ofapplications,andshallwhere
requestedensurethatapplicantsprovideacopyofthe
technicaldocumentation laiddowninArticle7.2.InclusionofanactivesubstanceinAnnexIshall,
whereappropriate,besubjecttothefollowing:
(i)requirementson:
(a)theminimumdegreeofpurityoftheactive
substance;
(b)thenatureandmaximumcontentofcertain
impurities;
(c)producttypeinwhichitmaybeused;
(d)mannerofuse;
(e)designationofcategoriesofusers(e.g.industrial,
professionalornon-professional );
(f)otherparticularconditionsfromtheevaluation
oftheinformationreferredtoinArticle10(2);
(ii)theestablishmentofthefollowing:
(a)asuitablestandardofuserprotection;
(b)whererelevant,anacceptabledailyintakefor
man(ADI);
(c)fateandbehaviourintheenvironmentand
impactonnon-targetorganisms.
3.TheinclsusioninAnnexIofanactivesubstance
shallberestrictedtothoseproducttypesinAnnexVfor
whichacceptabledatahavebeensubmittedin
accordancewithArticle7.
4.TheinclusionofasubstanceinAnnexImaybe
renewedononeormoreoccasionsforperiodsnot
exceeding10years.Theinitialinclusionaswellasany
renewedinclusionmaybereviewedatanytimeifthere9.MemberStatesmayrequirethatsamplesofthe
preparationandofitsingredientsbeprovided.
Article8
Placingonthemarketofactivesubstances
i
MemberStatesshallprescribethatwhereasubstanceis
anactivesubstanceforuseinbiocidalproductsitmay
notbeplacedonthemarketforsuchuseunless
r
i
(a)wheretheactivesubstancewasnotonthemarket
beforethedateofentryintoforceofthisDirective,
(')OJNoC146,15.6.1990,p.1;
OOJNoL15,17.1.1987,p.29.

NoC239/10 OfficialJournaloftheEuropeanCommunities 3.9.93
areindicationsthatanyoftherequirementsreferredto
inparagraph 1arenolongersatisfied.Renewalmay,
wherenecessary,begrantedonlyfortheperiod
necessarytocompleteareview,whereanapplicationhas
beenmadeforsuchrenewalandshallbegrantedforthe
periodnecessarytoprovideinformationrequestedin
accordancewithArticle10(2).recommendation fortheinclusion,orotherwise,ofthe
activesubstanceinAnnexI.
Ifduringtheevaluationofthedossiersitappearsthat
furtherinformationisnecessaryforfullevaluationtobe
made,thereceivingcompetentauthorityshallaskthat
theapplicantsubmitsuchinformation .Thesix-month
periodshallbesuspendedfromthedateofissueofthe
competentauthority'srequestuntilthedatetheinfor­
mationisreceived.Thecompetentauthorityshallinform
theotherMemberStatesandtheCommission ofits
actionatthesametimeasitinformstheapplicant.
3.Onreceiptoftheevaluation,theCommissionshall,
inaccordancewithinArticle24,prepareaproposal
withoutunduedelayfordecisioninaccordancewiththe
procedureslaiddowninArticle25(3).Thedecision
shallbetakenatthelatest15monthsafterthereceiptby
theCommission oftheevaluationreferredtoin
paragraph2.5.TheinclusionofanactivesubstanceinAnnexI
mayberefusedorreviewed,ifthereisanotheractive
substanceonAnnexIforthesameproducttype,or
anothermethodofcontrolexists,whichinthelightof
scientificortechnicalknowledgepresentsignificantlyless
risktohealthortotheenvironment .Whenconsidering
sucharefusal,anevaluationofthealternativeactive
substancesormethodsshallbeproducedinaccordance
withcommonprinciplesfortheevaluationofdossiers,to
demonstratetheycanbeusedwiththesameeffectonthe
targetorganismwithoutsignificanteconomicand
practicaldisadvantagestotheuser.Theevaluationshall
becirculatedinaccordancewiththeproceduresin
Article10(2)fordecisioninaccordancewiththe
procedureslaiddowninArticles24and25(3).
Article10
ProcedureforinclusionofanactivesubstanceinAnnexIArticle11
Useofdataheldbycompetentauthoritiesforother
applicants
1.MemberStatesshallnotmakeuseoftheinfor­
mationreferredtoinAnnexIIandtherelevantpartsof
AnnexIVforthebenefitofasecondorsubsequent
applicant:
(a)unlessthesecondorsubsequentapplicanthasthe
writtenagreementofthefirstapplicantthatusemay
bemadeofsuchinformation ;or
(b)inthecaseofanactivesubstancenotonthemarket
onthedateofcomingintoforceofthisDirective,
foraperiodof15yearsfromthedateoffirst
inclusioninAnnexI;or
(c)inthecaseofanactivesubstancealreadyonthe
marketonthedateofcomingintoforceofthis
Directive;
(i)foraperiodof10yearsfromthedateofcoming
intoforceofthisDirectiveforanyinformation
submittedforthepurposesofthisDirective
exceptwheresuchinformation isalready
protectedunderexistingnationalrulesrelating
tobiocidalproducts.Insuchcasestheinfor­
mationshallcontinuetobeprotectedinthat
MemberStateuntiltheexpiryofanyremaining
periodofdataprotectionprovidedforunder
nationalrules,uptoamaximumof10years
fromthedateorcomingintoforceofthis
Directive;
(ii)foraperiodof10yearsfromthedateofentry
ofanactivesubstanceontoAnnexIforinfor­
mationsubmittedforthefirsttimeinsupportof
thefirstinclusioninAnnexIofeithertheactive
substanceoranadditionalproducttypeforthat
activesubstance;1.Anactivesubstancewillbeconsideredforinclusion
inAnnexI,andanychangestoAnnexIwillbe
consideredwhen:
(a)anapplicanthasforwardedtothecompetent
authorityofoneoftheMemberStates:
(i)adossierfortheactivesubstancesatisfyingthe
requirementsofAnnexIIand,wherespecified,
therelevantpartsofAnnexIV;
(ii)adossierforatleastonebiocidalproduct
containingtheactivesubstancessatisfyingthe
requirementsofAnnexIIIan,wherespecified,
therelevantpartsofAnnexIV;
(b)thereceivingcompetentauthorityhascheckedthe
dossiersandbelievesthemtosatisfytherequirements
ofAnnexIIandAnnexIIIandwhererelevantAnnex
IV,acceptsthemandagreestotheapplicant
forwardingasummaryofthedossierstothe
CommissionandtheotherMemberStates.
2.Thereceivingcompetentauthorityshall,withinsix
monthsofacceptingthedossierscarryoutanevaluation
thereof.Acopyoftheevaluationshallbesentbythe
competentauthoritytotheCommission,theother
MemberStatesandtotheapplicant,togetherwitha

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/11
(d)inthecaseofanyfurtherinformationsubmittedfor
thefirsttimeforanyofthefollowing:
(i)variationoftheconditionsoftheentryonAn­
nexI;
(ii)maintenanceoftheentryonAnnexI
foraperiodoffiveyearsfromthedateof
decisionfollowingreceiptoffurtherinformation
unlessthefive-yearperiodexpiresbeforethe
periodprovidedforinparagraph 1(b)and(c),
inwhichcasetheperiodoffiveyearsshallbe
extendedsoastoexpireonthesamedataas
thoseperiods.
WhereanactivesubstanceisincludedinAnnexI
ofthisDirectiveandalsoinAnnexIofDirective
91/414/EEC,theinformationreferredtoin
AnnexIIandrelevantpartsofAnnexIV,which
isrequiredunderbothDirectivesandhasbeen
providedunderbothDirectives,shallbenefit
onlyfromtheperiodsofdataprotection
providedforunderDirective91/414/EEC.(d)inthecaseofanydatasubmittedforthefirsttime
foreitherofthefollowing:
(i)variationoftheconditionsofauthorizationofa
biocidalproduct;
(ii)submissionofdatanecessarytomaintainentry
ofanactivesubstanceontoAnnexI:
foraperiodoffiveyearsfromthedateoffirst
receiptoffurtherinformationunlessthe
five-yearperiodexpiresbeforetheperiodin
paragraph2(b)and(c)aboveinwhichcasethe
periodoffiveyearsshallbeextendedsoasto
expireonthesamedateasthoseperiods.
Whereabiocidalproductcontainsanactivesubstance
whichisincludedinAnnexIofthisDirectiveandalsoin
AnnexIofDirective91/414/EEC,theinformation
referredtoinAnnexIIIandrelevantpartsofAnnexIV,
whichisrequiredunderbothDirectivesandhasbeen
providedunderbothDirectives,shallbenefitonlyfrom
theperiodsofdataprotectionprovidedforunder
Directive91/414/EEC.
2.MemberStatesshallnotmakeuseoftheinfor­
mationreferredtoinAnnexIIIandtherelevantpartsof
AnnexIV,forthebenefitofasecondorsubsequent
applicant:
(a)unlessthe(secondorsubsequentapplicanthasthe
writtenagreementofthefirstapplicantthatusemay
bemadeofsuchinformation ;or
(b)inthecaseofabiocidalproductcontaininganactive
substancenotonthemarketonthedateofcoming
intoforceofthisDirective;foraperiodof10years
fromthedateoffirstauthorization inanyMember
State;or
(c)inthecaseofabiocidalproductcontaininganactive
substancealreadyonthemarketonthedateof
comingintoforceofthisDirective;
i
(i)foraperiodof10yearsfromthedateofcoming
intoforceofthisDirectiveforanyinformation
submittedforthepurposesofthisDirective,
exceptinthecasewheredataarealready
protectedaccordingtoexistingnationalrules
relatingtobiocidalproducts,inwhichcasesuch
datashallbeprotectedinthatMemberState
untiltheexpiryofanyremainingperiodofdata
protectionprovidedforunderthosenational
rules,uptoamaximumof10yearsfromthe
dateofcomingintoforceofthisDirective;
r
(ii)foraperiodof10yearsfromthedateofentry
ofanactivesubstanceontoAnnexI,forinfor­
mationwhichissubmittedforthefirsttimein
supportoftheinclusioninAnnexIeitherofthe
activesubstanceorofanadditionalproducttype
forthatactivesubstance;Article12
Secondandsubsequentapplicationsforauthorization
1.Inthecaseofabiocidalproductwhichhasalready
beenauthorizedinaccordancewithArticles3and4,and
withoutprejudicetotheobligationsimposedunder
Article11,thecompetentauthoritymayagreethata
secondorsubsequentapplicantforauthorizationmay
refertodataprovidedbythefirstapplicantinsofarasthe
secondorsubsequentapplicantcanprovideevidencethat
thebiocidalproductanditsactivesubstancesisthesame
astheonepreviouslyauthorized,includingdegreeof
purityandnatureofimpurities.
2.Notwithstanding Article7(2)wheretheactive
substanceislistedinAnnexI:
(a)applicantsforauthorizationofbiocidalproducts
shall,beforecarryingoutexperimentsinvolving
vertebrateanimals,enquireofthecompetent
authorityoftheMemberStatetowhichtheyintend
makingapplication :
—whetherthebiocidalproductforwhichan
applicationistobemadeisthesameasabiocidal
productforwhichauthorization hasbeen
granted,and
—astothenameandaddressoftheholderor
holdersoftheauthorization orauthorizations .
Theenquiryshallbesupportedbyevidencethatthe
prospectiveapplicantintendstoapplyforauth­
orizationonhisownbehalfandthattheotherinfor­
mationspecifiedinArticle7(2)isavailable;

NoC239/12 OfficialJournaloftheEuropeanCommunities 3.9.93
mationtheyreceiveconcerningpotentiallyharmful
effectsformanortheenvironmentofabiocidalproduct,
itsactivesubstances,impurities,co-formulants or
residues.(b)thecompetentauthorityoftheMemberState,if
satisfiedthattheapplicantintendstoapply,shall
providethenameandaddressoftheholderor
holdersofpreviousrelevantauthorizations andshall
atthetimeinformtheholdersoftheauthorizations
ofthenameundaddressoftheapplicant.
Theholderorholdersofpreviousauthorizations and
theapplicantshalltakeallreasonablestepstoreach
agreementonthesharingofinformationsoasto
avoidtheduplicationoftestingonvertebrate
animals.
Wheredataisrequestedwithaviewtoinclusionin
AnnexIofanactivesubstancealreadyonthemarket
onthedateofentryintoforceofthisDirective,the
competentauthoritiesoftheMemberStatesshall
encouragedataholderstocooperateintheprovision
oftherequesteddata,withaviewtolimitingthe
duplicationoftestingonvertebrateanimals.
Iftheapplicantandholdersofpreviousauthor­
izationsofthesameproductcanstillnotreachan
agreementonthesharingofdata,MemberStates
mayintroducenationalmeasuresobligingthe
applicantandholdersofpreviousauthorizations
locatedwithintheirterritorytosharethedatawitha
viewtoavoidingduplicativetestingonvertebrate
animalsanddetermineboththeprocedurefor
utilizinginformation,andthereasonablebalanceof
theinterestsofthepartiesconcerned.Article14
Transitional measuresandderogationsfromthe
requirements
1.BywayofderogationfromArticle3and4,a
MemberStatemayauthorizetemporarilyforaperiod
notexceeding 120daystheplacingonthemarketof
biocidalproductsnotcomplyingwiththeprovisionsof
thisDirectiveforalimitedandcontrolleduseifsucha
measureappearsnecessarybecauseofanunforseen
dangerwhichcannotbecontainedbyothermeans.In
thiscase,theMemberStateconcernedshallimmediately
informtheotherMemberStatesandtheCommissionof
itsactionandthejustificationforit.TheCommission
shallmakeaproposalanditshallbedecidedwithout
delay,inaccordancewiththeprocedurelaiddownin
Article25,whetherandunderwhichconditionsthe
actiontakenbytheMemberStatemaybeextendedfora
periodtobedetermined,berepeated,orberevoked.
I
> •
I
2.BywayofderogationfromArticle4(1)(a)and
untilanactivesubstanceislistedinAnnexIaMember
Statemayauthorizeprovisionally ,foraperiodnot
exceeedingthreeyears,theplacingonthemarketofa
biocidalproductcontaininganactivesubstancenotlisted
inAnnexIandnotyetavailableonthemarketonthe
dateofcomingintoforceofthisDirective.Suchan
authorizationmayonlybeissuedif,afterevaluationof
dossiersinaccordancewiththeArticle10theMember
Statebelievesthat:Article13
Newinforation
\
—theactivesubstancesatisfiestherequirementsof
Article9and,
—thebiocidalproductmaybeexpectedtosatisfythe
conditionsofArticled(1)(b),(c)and(d),
»1.MemberStatesshallprescribethattheholderofan
authorizationforabiocidalproductshallimmediately
notifythecompetentauthorityofinformationwhich
theymayreasonablybeexpectedtobeawareconcerning
anactivesubstanceorabiocidalproductcontainingit
andwhichmayaffectcontinuingauthorization .In
particularthefollowingshallbenotified:
—newknowledgeorinformationontheeffectsofthe
activesubstanceorbiocidalproductformanorthe
environment ,
—changesinthesourceorcompositionofanactive
substance,
—changesincompositionofabiocidalproduct.andnootherMemberState,onthebasisofthesummary
itreceives,makeslegitimateobjectioninaccordancewith
Article16(2)tothecompletenessofthedossiers.Where
anobjectionismadeadecisiononthecompletenessof
dossiersshallbetakeninaccordancewiththeprocedures
laiddowninArticle25(3)withoutunduedelay.
/
<
IffollowingtheprocedureslaiddowninArticle24and
25(3),itisdecided,thattheactivesubstancedoesnot
satisfytherequirements specifiedinArticle9,the
MemberStateshallensurethattheprovisionalauthor­
izationiscancelled.
i'
Incaseswhereevaluationofdossiersforthepurposesof
inclusionofanactivesubstanceinAnnexIisnot2.MemberStatesshallimmediatelynotifyother
MemberStatesandtheCommissionofanysuchinfor­

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/13
(b),(c)and(d)onthebasisofdossierswhichaddressthe
requirementsinAnnexIIandIII.completedwhentheperiodofthreeyearsexpires,the
competentauthoritymayfurtherprovisionallyauthorize
theproductforaperiodi^otexceedingoneyear,
providingtherearegoodreasonstobelievetheactive
substancewillsatisfytherequirementsofArticle9.
MemberStatesshallinformotherMemberStatesandthe
Commissionofsuchaction.Article15
Researchanddevelopment
(1)MemberStatesshallprescribethatanyexperiment
ortestforthepurposesofresearchordevelopment
involvingplacingonthemarketofanunauthorized
biocidalproductoranactivesubstanceintendedexclu­
sivelyforuseinabiocidalproductshallnottakeplace
unless:3.BywayoffurtherderogationfromArticle4(1),
Article7(2)andArticle7(3)andwithoutprejudiceto
paragraph4andparagraph6,aMemberStatemay,for
aperiodof10yearsfromthedateofentryintoforceof
thisDirective,authorizetheplacingonthemarketinits
territoryofabiocidalproductcontainingactive
substancesnotlistedinAnnexIthatareonthemarket
onthedateofentryintoforceofthisDirective.
(ainthecaseofscientificresearchanddevelopmentthe
personsconcerneddrawupandmaintainwritten
recordsdetailingtheidentityoftheproductor
substance,labellingdata,quantitiessuppliedandthe
namesandaddressesofthosepersonsreceivingthe
productorsubstanceandcompilesadossier
containingallavailabledataonpossibleeffectson
humanoranimalhealthorimpactonthe
environment .Thisinformationshall,asrequested,be
madeavailabletothecompetentauthority;4.FollowingtheadoptionofthisDirective,the
Commissionshallcommencea10-yearprogrammeof
workforthesystematicexaminationofactivesubstances
notonAnnexI.Aregulation,adoptedaccordingtothe
procedurelaiddowninArticle25(2),willprovideforall
provisionsnecessaryfortheestablishmentandimplemen­
tationoftheprogramme .Nolaterthantwoyearsbefore
completionoftheworkprogramme,theCommission
shallforwardtotheCouncilandtheEuropean
Parliamentareportontheprogressachievedwiththe
programme .(b)inthecaseofprocess-orientated researchanddevel­
opmenttheinformationrequiredin(a)isnotifiedto
thecompetentauthoritywhereandbeforeplacingon
themarketoccursandtothecompetentauthorityof
theMemberStatewheretheexperimentortestisto
beconducted . Duringthis10-yearperiod,itmaybedecidedunderthe
procedurelaiddowninArticle25(3)thatanactive
substanceshallbeincludedinAnnexIandunderwhich
conditions,or,incaseswheretherequirementsofArticle
9arenotsatisfiedortherequisiteinformationanddata
havenotbeensubmittedwithintheprescribedperiod,
thatsuchactivesubstanceshallnotbeincludedinAn­
nexI.2.MemberStatesshallprescribethatanunauthorized
biocidalproductoranactivesubstanceforexclusiveuse
inabiocidalproductmaynotbeplacedonthemarket
forthepurposeoftrialswhichmayinvolveorresultin
releaseintotheenvironment unlessthecompetent
authorityhasassessedtheavailabledataandissuedan
authorizationfortrialspurposeswhichlimitsthequan­
titiestobeusedandtheareastobetreatedandmay
imposefurtherconditions .Followingadecision,theMemberStatesshallensure
thatauthorizations forbiocidalproductscontainingthe
activesubstancesaremodifiedorcancelledasappro­
priate.
3.WheretrialstakeplaceinaMemberStateother
thantheMemberStatewhereplacingonthemarket
occurs,theapplicantshallobtaintrialsauthorization
fromthecompetentauthorityoftheMemberStatein
whoseterritorythetrialsaretobeconducted.5.Wherefollowinga
isconcludedthatthe
requirementsofArticle
includedinAnnexI,the
proposalsforrestricting
substanceinaccordancereviewofanactivesubstanceit
substancedoesnotmeetthe
9andconsequentlycannotbe
Commissionshallbringforward
themarketinganduseofthat
withDirective76/769/EEC.
Iftheproposedexperimentsortestsreferredtoin
paragraph 1and2areliabletohaveharmfuleffectson
humanoranimalhealthortohaveanunacceptable
adverseinfluenceontheenvironment ,theMemberState
concernedmayeitherprohibitthemoronlypermitthem
subjecttosuchconditionsasitconsidersnecessaryto
preventthoseconsequences .6.Whenauthorizingbiocidalproductscontainingan
activesubstancetobereviewedinaccordancewith
paragraph4andbeforesuchreviewhastakenplace,
MemberStatesshallapplytheconditionsinArticle4(1)

NoC239/14 OfficialJournaloftheEuropeanCommunities 3.9.93
Article17
Confidentiality
1.WithoutprejudicetoCouncilDirective
90/313/EEConthefreedomofaccesstoinformationon
theenvironmentOanapplicantmayindicatetothe
competentauthoritytheinformationwhichheconsiders
tobecommercially sensitiveanddisclosureofwhich
mightharmhimindustriallyorcommerciallyandwhich
hethereforewishestobekeptconfidentialfromall
personsotherthanthecompetentauthoritiesandthe
Commission .Fulljustificationwillberequiredineach
case.
(2)Thecompetentauthorityreceivingtheapplication
shalldecidewhichinformation shallbeconfidential
withinthetermsofparagraph 1.
Informationacceptedasbeingconfidentialbythe
receivingcompetentauthorityshallbetreatedasbeing
confidentialbytheothercompetentauthorities,Member
StatesandtheCommission .4.Paragraph2shallnotapplyiftheMemberState
hasgrantedthepersonconcernedtherighttoundertake
certainexperimentsandtestsandhasdeterminedthe
conditionsunderwhichtheexperimentsandtestshaveto
beundertaken .
i
5.Commonconditionsfortheapplicationofthis
Article,inparticularthemaximumquantitiesofactive
substancesorbiocidalproductsthatmaybereleased
duringexperiments,andtheminimumdatatobe
submittedinaccordancewithparagraph2,shallbe
adoptedinaccordancewiththeprocedurelaiddownin
Article25(3).
Article16
Informationexchange
1.Withinaperiodofonemonthfromtheendofeach
quarterMemberStatesshallinformeachotherandthe
Commissionofanybiocidalproductswhichhavebeen
authorizedwithintheirterritoryorforwhichanauthori­
zationhasbeenrefused,modified,renewedorcancelled,
indicatingatleast:
(a)thenameorbusinessnameoftheholderoftheauth­
orization;
\
(b)thetradenameofthebiocidalproduct;
(c)thenameandamountofeachactivesubstancewhich
itcontains;3.Confidentiality shallnotinanycaseapplyto:
(a)thenameoftheapplicant;
(b)thenameofthebiocidalproductmanufacturer ;
(c)thenameoftheactivesubstancemanufacturer ;
(d)thenamesandcontentoftheactivesubstancesor
substancesinthebiologicalproductandthenameof
thebiocidalproduct;
(e)thenameofothersubstanceswhichareregardedas
dangerousunderDirectives67/548/EECand
contributetotheclassificationoftheproduct;
(f)physico-chemical dataconceringtheactivesubstance
andbiocidalproduct;
(g)anywaysofrenderingtheactivesubstanceor
biocidalproductharmless;
(h)asummaryoftheresultsofthetestsrequiredunder
Article7toestablishthesubstance'sorproduct's
efficacyandeffectsonhumans,animalsandthe
environment ;
(i)recommended methodsandprecautionstoreduce
dangersfromhandling,storage,transportanduseas
wellasfromfireorotherhazards;
(j)methodsofanalysisreferredtoinArticle4(1)(c);
(k)methodsofdisposaloftheproductandofits
packaging;(d)theproducttypeandtheuseorusesforwhichitis
authorized;
(e)thetypeofformulation;
(f)anyproposedlimitsonresidueswhichhavebeen
established;
(g)limitations,conditionsandrequirementsoftheauth­
orizationandwhererelevant,thereasonsforthe
modificationorcancellationofanauthorization .
2.WhereaMemberStatereceivesasummaryofthe
dossiersinaccordancewithArticle10(1)(b)andhas
legitimatereasontobelievethedossiersareincompleteit
shallimmediatelycommunicate itsconcernstothe
competentauthorityresponsiblefortheevaluationofthe
dossiersandshallimmediatelyinformtheCommission
andotherMemberStatesofitsconcerns.
0
3.EachMemberStateshalldrawupanannuallistof
thebiocidalproductsauthorizedinitsterritoryandshall
communicate thatlisttotheotherMemberStatesand
theCommission .
4.Inaccordancewiththeprocedurelaiddownin
Article25(2)astandardizedinformationsystemshallbe
setuptofacilitatetheapplicationofparagraphs 1and2.(')OJNoL158,23.6.1990,p.56.
«

NoC239/15 3.9.93 OfficialJournaloftheEuropeanCommunities
'
(1)decontamination procedurestobefollowedinthe
caseofaccidentalspillageorleakage;
t
(m)firstaidandmedicaltreatmenttobegiveninthe
caseofinjurytopersons.
Iftheapplicantormanufacturerorimporterofthe
biocidalproductoractivesubstanceshouldlaterdisclose
previouslyconfidentialinformation,thecompetent
authorityshallbeinformedaccordingly .
i
4.Thedetailedprovisionsandformatformaking
informationpubliclyavailableshallbedecidedin
accordancewiththeproceduressetoutinArticle25(2).(e)directionsforuseandthedoserate,expressedin
metricunits,foreachuseprovidedforunderthe
termsoftheauthorization ;
(f)particularsoflikelyorindirectadversesideeffects
andanydirectionsforfirstaid;
i
(g)ifaccompaniedbyaleafletthesentence'Read
attachedinstructionsbeforeuse';
(h)directionsforsafedisposalofthebiocidalproduct
anditspackaging;includingwhererelevantany
prohibitiononre-useofpackaging;
(i)theformulationbatchnumberordesignationandthe
expirydaterelevanttonormalconditionsofstorage;
andwhereapplicable:
v
(j)theintervaltobeobservedbetweenapplicationsof
thebiocidalproductorbetweenapplicationandthe
nextuseoftheproducttreated,orthenextaccessby
manoranimalstotheareawherethebiocidal
producthasbeenused;
(k)thecategoriesofuserstowhichthebiocidalproduct
isrestricted;
(1)informationonanyspecificdangerstothe
environmentparticularlyconcerningprotectionof
non-targetspeciesandavoidanceofcontamination
ofwater.Article18
Classification,packagingandlabellingof
biocidalproducts
1.Biocidalproductsshallbeclassifiedaccordingto
theprovisionsrelatingtoclassificationinDirective
88/379/EEContheclassification,packagingand
labellingofdangerouspreparations(1).
2.Biocidalproductsshallbepackagedaccordingto
Article6ofDirective88/379/EEC.Inaddition:
i
(a)productswhichmaybemistakenforfoodordrink
shallbepackagedtominimizethelikelihoodofsuch
amistakebeingmade;
(b)productsavailabletothegeneralpublicwhichmay
bemistakenforfoodordrinkshallcontain
componentstodiscouragetheirconsumption .
t
3.Biocidalproductsshallbelabelledaccordingtothe
provisionsofDirective88/379/EECconcerning
labelling.Inadditionthelabelmustshowclearlyand
indeliblythefollowing:MemberStatesshallrequirethatitems3(a),(b),(d)and
whereapplicable(g)and(k)alwaysbecarriedonthe
labeloftheproduct.
MemberStatesshallpermititems3(c),(e),(f),(h),(i),
(j)and(1)tobecarriedelsewhereonthepackagingor
onanaccompanying leafletintegraltothepackaging.
Theseitemsofinformationshallberegardedaslabel
informationforthepurposesofthisDirective. I
(a)theidentityoftheactivesubstanceanditsconcen­
trationinmetricunits;
(b)theauthorizationnumberallocatedtothebiocidal
productbythecompetentauthority;4.Bywayofderogationfromparagraphs 1and2and
thefirstsentenceofparagraph3,biocidalproductsauth­
orizedasinsecticides,acaricides,rodenticides,avicides
ormolluscicidesshallbeclassifiedpackagedandlabelled
inaccordancewithDirective78/631/EEConthe
approximationofthelawsoftheMemberStatesrelating
totheclassification,packagingandlabellingof
dangerouspreparations(pesticides)(*)insofarasthereis
nootherCommunityprovisionsspecificallycovering
thesemattersforsuchproducts.(c)thetypeofpreparation(e.g.liquidconcentrates,
granules,powders,solids,etc.);
«
(d)theusesforwhichthebiocidalproductisauthorized
(e.g.woodpreservation,disinfection,surfacebiocide,
anti-fouling,etc);
OOJNoL187,16.7.1988,p.14. (l)OJlyoL206,29.7.1978,p.13.

s
NoC239/16 OfficialJournaloftheEuropeanCommunities 3.9.93
Article21 5.Whereabiocidalproductidentifiedinparagraph4
isauthorizedunderthisDirectiveandisalsosubjectto
classification,packagingandlabellingaccordingto
Directive78/631/EECbyvirtueofotherCommunity
provisions,MemberStatesshallpermitchangestothe
packagingandlabellingofthatproductwhichmaybe
requiredasaconsequenceofthoseprovisions,insofaras
theydonotconflictwiththerequirementsofan
authorization issuedunderthisDirective.
6.MemberStatesmayrequiretheprovisionof
samples,modelsordraftsofthepackaging,labellingand
leaflets.
Article19
Safetydatasheets
MemberStatesshallensurethatasystemofspecific
information(insafety-data-sheet form)isestablishedto
enableprofessionalandindustrialusersofbiocidal
productstotakethenecessarymeasureforthe
protectionoftheenvironmentandhealthsafetyatthe
workplace. vPoisoncontrol
MemberStatesshallappointthebodyorbodies
responsibleforreceivinginformationonbiocidal
productswhichhavebeenplacedonthemarket,
includinginformationonthechemicalcomposition,of
suchproducts,andformakingsuchinformation
availableincaseswheresuspectedpoisoningarisesfrom
theuseofbiocidalproducts.Suchinformationmayonly
beusedtomeetanymedicaldemandbyformulating
preventiveandcurativemeasures,inparticularinemer­
gencies.MemberStatesshallensurethattheinformation
isnotusedforotherpurposes.
MemberStatesshalltakethenecessarystepstoensure
thattheappointedbodiesprovidealltherequisiteguar­
anteesformaintainingtheconfidentiality oftheinfor­
mationreceived.MemberStatesshallensurethatthe
appointedbodiesshallhaveattheirdisposalalltheinfor­
mationrequiredtocarryoutthetasksforwhichtheyare
responsiblefromthemanufacturers orpersons
responsibleformarketing .
Forbiocidalproductsalreadyonthemarket,Member
StatesshalltakemeasurestocomplywiththisDirective
withinthreeyearsfromtheadoptionthereof.
Article22
Compliancewithrequirements
MemberStatesshallmakesuitablearrangementsfor
biocidalproductswhichhavebeenplacedonthemarket
tobeofficiallymonitoredtoestablishwhetherthey
complywiththerequirementsofthisDirective.
Everythreeyearsaftertheentryintoforceofthis
Directive,MemberStatesshallforwardtothe
Commissionbythe30Novemberofthethirdyeara
reportontheiractioninthesematterstogetherwith
informationonanypoisoningsinvolvingbiocidal
products.TheCommissionshallwithinoneyearof
receiptofthisinformationprepareandpublisha
compositereport.\
Foractivesubstancesusedexclusivelyinbiocidal
productssafetydatasheetsshallbepreparedin
accordancewiththerequirementsofArticle27of
Directive67/548/EEC.
-
Forbiocidalproductssafetydatasheetsshallbeprepared
inaccordancewithArticle10ofDirective88/379/EEC.
Article20
Advertising
1.MemberStatesshallrequirethateveryadver­
tisementforabiocidalproductisaccompaniedbythe
sentences'Usebiocidessafely.Alwaysreadthelabeland
productinformationbeforeuse'.
tThesentencesshallbeclearlydistinguishable inrelation
tothewholeadvertisement .
MemberStatesshallprescribethatadvertisersmay
replacetheword'biocides'intheprescribedsentences
withanaccuratedescriptionoftheproducttypebeing
advertisede.g.woodpreservatives,disinfectants,surface
biocides,anti-foulingproducts,etc.
2.MemberStatesshallrequirethatadvertisementsfor
biocidalproductsshallnotrefertotheproductina
mannerwhichismisleadinginrespectoftheeffectsof
thesubstanceonmanortheenvironment .Article23
Competentauthorities
1.MemberStatesshalldesignateacompetent
authorityresponsibleforcarryingoutthedutiesimposed
onMemberStatesunderthisDirective.
2.MemberStatesshallinformtheCommissionofthe
identityoftheircompetentauthoritysixmonthsbefore
theentryintoforceofthisDirective.

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/17
Article24
CommissionproceduresCommittee)toassistit.TheStandingCommitteeshallbe
composedofrepresentatives oftheMemberStatesand
chairedbyarepresentative oftheCommission .The
StandingCommitteeshalladoptitsownrulesof
procedure .1.WhentheCommission receivesfromaMember
Stateeither:
(a)anevaluationandrecommendations concerningan
activesubstanceasforeseeninArticle10(2)and
Article9(5);or2.FormattersreferredtotheStandingCommitteeby
virtueofArticles14(4),16(4)and17(4)therepresen­
tativeoftheCommissionshallsubmittotheCommittee
adraftofthemeasurestobetaken.TheCommitteeshall
deliveritsopiniononthedraft,withinatimelimitwhich
thechairmanmaylaydownaccordingtotheurgencyof
thematter,ifnecessarybytakingavote.(b)aproposaltorefuseanauthorizationandanexpla­
natorydocumentasforeseeninArticle3(5"):
itshallallowaperiodof45daysduringwhichother
MemberStatesandtheapplicantmaysubmitcomments
toitinwriting••
Theopinionshallberecordedintheminutes;in
addition,eachMemberStateshallhavetherighttoask
tohaveitspositionrecordedintheminutes. 2.Attheendoftheperiodforcomment,the
Commissionshall,onthebasisof:
thedocumentsreceivedfromtheMemberState
evaluatingthedossiersand,TheCommission shalltaketheutmostaccountofthe
opiniondeliveredbytheCommittee .Itshallinformthe
Committeeofthemannerinwhichitsopinionhasbeen
takenintoaccount.anyadviceobtainedfromadvisorycommitteesin
particulartheScientificAdvisoryCommitteeonthe
toxicologyandecotoxicologyofchemicalsubstances
asestablished byCommission Decision
78/618/EEC(')andinthecaseofactivesubstances
includedininsecticides,acaricides,rodenticides,
avicidesandmolluscicides whicharealsoauthorized
undertherequirementsofDirective91/414/EEC,
theScientificCommitteeforPesticides,asestablished
byCommissionDecision78/436/EEC(2),
commentsreceivedfromotherMemberStatesand
theapplicantsand,
anyotherrelevantinformation,3.ForallothermattersreferredtotheCommitteein
accordancewiththerequirementsofthisDirectivethe
representative oftheCommissionshallsubmittothe
Committeeadraftofthemeasurestobetaken.The
Committeeshalldeliveritsopiniononthedraftwithina
timelimitwhichthechairmanmaylaydownaccording
totheurgencyofthematter.Theopinionshallbe
deliveredbythemajoritylaiddowninArticle148(2)of
theTreatyinthecaseofdecisionswhichtheCouncilis
requiredtoadoptonaproposalfromtheCommission .
Thevotesoftherepresentatives oftheMemberStates
withintheCommitteeshallbeweightedinthemanner
setoutinthatArticle.Thechairmanshallnotvote.prepareaproposalfordecisioninaccordancewiththe
procedureslaiddowninArticle25(3).
TheCommissionshalladoptthemeasuresenvisagedif
theyareinaccordancewiththeopinionofthe
Committee .3.Theapplicantorhisauthorizedrepresentativemay
beaskedbytheCommissiontosubmitremarkstoit,in
particularwheneveranunfavourable decisionis
envisaged.
Article25
CommitteesandproceduresIfthemeasuresenvisagedarenotinaccordancewiththe
opinionoftheCommittee,orifnoopinionisdelivered,
theCommissionshall,withoutdelay,submittothe
Councilaproposalrelatingtothemeasurestobetaken.
TheCouncilshallactbyaqualifiedmajority.
1.TheCommission shallestablishaStanding
CommitteeonBiocidalProducts(theStanding
If,ontheexpiryofaperiodof30daystheCouncilhas
notacted,theproposedmeasuresshallbeadoptedbythe
Commission .OOJNoL198,22.7.1978,p.17.
OOJNoL124,12.5.1978,p.16.

NoC239/18 OfficialJournaloftheEuropeanCommunities 3.9.93
Article26
Commonprinciplesfortheevaluationofdossiers
Thecommonprinciplesforevaluationofdossiers
referredtoinArticle4(1)(b)above,shallbeadoptedin
accordancewiththeprocedurelaiddowninArticle25
(3).Theseprinciplesshallberegularlyreviewedand
whereappropriaterevised,inaccordancewiththesame
procedure.
Article27Article29
Safeguardclause
WhereaMemberStatehasvalidreasonstoconsiderthat
abiocidalproductwhichithasauthorizedorisboundto
authorizeunderArticle3constitutesanunacceptable
risktohumanoranimalhealthortheenvironment ,it
mayprovisionallyrestrictorprohibittheuseorsaleof
thatproductonitsterritory.Itshallimmediatelyinform
theCommissionandtheotherMemberStatesofsuch
actionandgivereasonsforitsdecision.Adecisionshall
betakenonthematterwithin90daysinaccordance
withtheprocedurelaiddowninArticle25(3).
Article30
Implementation oftheDirective
1.Notlaterthan18monthsafterthedateofthe
adoptionoftheDirectiveMemberStatesshalladoptand
publishthelaws,regulationsandadministrative
provisionsnecessarytocomplywiththisDirective.They
shallforthwithinformtheCommissionthereof.
2.WhenMemberStatesadoptthesemeasures,they
shallcontainareferencetothisDirectiveorshallbe
accompaniedbysuchreferenceontheoccasionoftheir
officialpublication .Themethodsofmakingsucha
referenceshallbelaiddownbytheMemberStates.
Article31Adaptationtotechnicalprogress
TheamendmentsnecessaryforadaptingAnnexesII,III,
IVandVtotechnicalprogressshallbeadoptedin
accordancewiththeprocedurelaiddowninArticle25
(3).
Article28
Civilandcriminalliability
Thegrantingofauthorizationandallothermeasuresin
conformitywiththisDirectiveshallbewithoutprejudice
togeneralcivilandcriminalliabilityintheMember
Statesofthemanufacturerand,whereapplicable,ofthe
personresponsibleforplacingthebiocidalproducton
themarketorusingit. ThisDirectiveisaddressedtotheMemberStates.
ANNEXI
LISTOFACTIVESUBSTANCES WITHREQUIREMENTS AGREEDATCOMMUNITY LEVEL
FORINCLUSION INBIOCIDALPRODUCTS
i
ANNEXII
REQUIREMENTS FORTHEDOSSIERTOBEINTRODUCED FORTHE
INCLUSION OFANACTIVESUBSTANCE INANNEXI
PARTA
Chemicalsubstances
1.Dossiersonactivesubstancesarerequiredtoaddressatleastallthepointslistedunder'Dossier
requirements'.Responsesarerequiredtobesupportedbydata.
/

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/19
2.Informationwhichisnotnecessaryowingtothenatureofthebiocidalproductorofitsproposeduses
neednotbesupplied.Thesameapplieswhereitisnotscientificallynecessaryortechnicallypossibleto
supplytheinformation .Insuchcases,ajustification,acceptabletothecompetentauthoritymustbe
submitted .
Dossierrequirements
> »
/
>
IApplicant
IIIdentityoftheactivesubstance
IIIPhysicalandchemicalpropertiesoftheactivesubstance
IVMethodsofdetectionandidentification
VEffectivenessagainsttargetorganismsandintendeduses
VIToxicologicalprofileformanandanimalsincludingmetabolism
VIIEcotoxicological profileincludingenvironmentalfateandbehaviour
VIIIMeasuresnecessarytoprotectman,animalsandtheenvironment
IXClassificationandlabelling
XSummaryandevaluationofIItoIX
i
Thefollowingdatawillberequiredtosupportsubmissionontheabovepoints.
IAPPLICANT
1.1.Name4-address.
1.2.Activesubstancemanufacturer (name,address,locationofplant).
IIIDENTITYOFTHEACTIVESUBSTANCE
2.1.CommonnameproposedoracceptedbyISOandsynonyms.
2.2.Chemicalname(IUPACnomenclature).
2.3.Manufacturer'sdevelopmentcodenumber(s).
2.4.CASandEECnumbers(ifavailable).
2.5.Empiricalandstructuralformula(includingfulldetailsofanyisomericcomposition),molecular
mass.
2.6.Methodofmanufacture(synthesispathwayinbriefterms)ofactivesubstance.
2.7.Specificationofpurityoftheactiveing/kgorg/1,asappropriate .
2.8.Identityofimpuritiesandadditives(e.g.stabilizers),togetherwiththestructuralformulaandthe
possiblerangeexpressedasg/kgorg/1,asappropriate .
2.9.Theoriginofthenaturalactivesubstanceortheprecursor(s)oftheactivesubstance,e.g.an
extractofaflower.

0
NoC239/20 OfficialJournaloftheEuropeanCommunities 3.9.93
IIIPHYSICALANDCHEMICAL PROPERTIES OFTHEACTIVESUBSTANCE
3.1.Meltingpoint,boilingpoint,relativedensity(').
3.2.Vapourpressure(inPa)(').
3.3.Appearance(physicalstate,colour)(2).
3.4.Absorptionspectra(UV/VIS,IR,NMR),andamassspectrum,molarextinctionatrelevant
wavelengths,whererelevant(').
3.5.SolubilityinwaterincludingeffectofpH(5to9)andtemperatureonsolubility,where
relevant(').
3.6.Solubilityinorganicsolvents,includingeffectoftemperatureonsolubility(').
3.7.Partitioncoefficientn-octanol/waterincludingeffectofpH(5to9)andtemperature(').
3.8.Stabilityinorganicsolventsusedinpreparationsandidentityofrelevantbreakdownproducts(2).
3.9.Thermalstability,identityofrelevantbreakdownproducts.
3.10.Flammabilityincludingauto-flammability andidentityofcombustionproducts.
3.11.Flashpoint .
3.12.Surfacetension.
3.13.Explosiveproperties.
3.14.Oxidizingproperties.
3.15.Reactivitytowardscontainermaterial.
IVANALYTICAL METHODS FORDETECTION ANDIDENTIFICATION
4.1.Analyticalmethodsforthedeterminationofpureactivesubstanceand,whereappropriate,for
relevantdegradationproducts,isomersandimpuritiesoftheactivesubstanceandadditives(e.g.
stabilizers).
4.2.Analyticalmethodsincludingrecoveryratesandthelimitsofdetermination fortheactive
substance,andforresiduesthereof,andwhererelevantin/onthefollowing:
(a)soil;
i,
(b)air;
(c)water:theapplicantshouldconfirmthatthesubstanceitselfandanyofitsdegradation
productswhichfallwithinthedefinitionofpesticidesgivenforparameter55inAnnexIof
Directive80/778/EEConthequalityofwaterintendedforhumanconsumption (OJNo
L229,30.8.1980,p.11)canbeestimatedwithadequatereliabilityattheMACspecifiedin
thatDirectiveforindividualpesticides;
(d)animalandhumanbodyfluidsandtissues;
(e)foodorfeedingstuffsandotherproductswhererelevant.
(')Thesedatamustbesubmittedforthepurifiedactivesubstanceofstatedspecification .
(J)Thesedatamustbesubmittedfortheactivesubstanceofstatedspecification .

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/21
VEFFECTIVENESS AGAINSTTARGETORGANISMS ANDINTENDED USES
5.1.Function,e.g.fungicide,rodenticide,insecticide,bacteriocide .
5.2.Organism(s)controlledandproducts,organismsorobjectstobeprotected.
5.3.Effectsontargetorganisms,e.g.contact,inhalationorstomachpoison,fungitoxic,orfungistatic.
5.4.Modeofaction.
5.5.Fieldofuseenvisaged.
5.6.User,professionalornon-professional ,generalpublic.
5.7.Informationontheoccurrenceorpossibleoccurrenceofthedevelopmentofresistanceand
appropriatemanagementstrategies.
5.8.Likelytonnagetobeplacedonthemarketperyear.
5.9.Observationsonundesirableorunintendedside-effects,e.g.onbeneficialandothernon-target
organisms.
VITOXICOLOGICAL ANDMETABOLIC STUDIES
6.1.Acutetoxicity.
6.1.1.Oral.
6.1.2.Dermal
6.1.3.Inhalation .
6.1.4.Skinandeyeirritation.
6.1.5.Skinsensitization .
6.2.Metabolismstudiesinmammals.
Basictoxicokinetics ,includingadermalabsorptionstudy.
Forthefollowingstudies6.3(wherenecessary),6.4,6.5,6.7and6.8,therequiredrouteof
administration istheoralrouteunlessitcanbejustifiedthatanalternativerouteismoreappro­
priate.
6.3.Shorttermrepeateddosetoxicity(28days).
Thisstudyisnotrequiredwhenasub-chronictoxicitystudyisavailableinarodent.
6.4.Sub-chronictoxicity.
I
90-daystudy,twospecies,onerodentandonenon-rodent .
6.5.Chronictoxicity.
#
«
Onerodentandoneothermammalianspecies.
6.6.Mutagenicitystudies.
6.6.1.Invitrogenemutationstudyinbacteria.
6.6.2.Invitrocytogenicitystudyinmammalianceils.
6.6.3.Invitrogenemutationassayinmammalianceils.
6.6.4.Ifpositiveinpoints6.6.1,6.6.2or6.6.3,thenaninvivomutagenicitystudywillberequired
(bonemarrowassayforchromosomaldamageoramicronucleustest).

NoC239/22 OfficialJournaloftheEuropeanCommunities 3.9.93
6.6.5.Ifnegativeinpoint6.6.4butpositiveinvitroteststhenundertakeasecondinvivostudyto
examinewhethermutagenicityorevidenceofDNAdamagecanbedemonstratedintissueother
thanbonemarrow.
6.6.6.Ifpositiveinpoint6.6.4thenatesttoassesspossiblegermcelleffectsmayberequired.
6.7.Carcinogenicity study.
Onerodentandoneothermammalianspecies.Thesestudiesmaybecombinedwiththosein
point6.5.
6.8.Reproductivetoxicity.
6.8.1.Teratogenicity test—rabbitandonerodentspecies
6.8.2.Fertilitystudy—atleasttwogenerations,onespecies,maleandfemale
6.9.Neurotoxicitystudy.
Iftheactivesubstanceisanorganophosphorus compoundorifthereareanyotherindications
thatthetestsubstancemayhaveneurotoxicpropertiesthenneurotoxicitystudieswillberequired.
Thetestspeciesistheadulthenunlessanotherspeciesisjustifiedtobemoreappropriate .If
appropriate,delayedneurotoxicitytestswillberequired.Ifanticholineesteraseactivityis
detected,atestforresponsetoreactivatingagentsshouldbeconsidered.
6.10.Toxiceffectsonlivestockand,pets.
6.11.Studiesrelatedtotheexposureoftheactivesubstancetoman.
6.11.1.Foodandfeedingstuffs—iftheactivesubstanceistobeusedinpreparationsforusewherefood
forhumanconsumptionisprepared,consumedorstored,orwherefeedingstuffforlivestockis
prepared,consumedorstoredthetestsreferredtoinAnnexIV,PartA,point1shallberequired.
6.11.2.Ifanyothertestsrelatedtotheexposureoftheactivesubstancetoman,initsproposedprepa
rations,areconsiderednecessary,thenthetest(s)inAnnexIV,PartA,point2shallberequired.
6.12.Supplementary studies.
6.12.1.Iftheactivesubstanceistobeusedinproductsforactionagainstplantsthenteststoassesstoxic
effectsofmetabolitesfromtreatedplants,ifany,wheredifferentfromthoseidentifiedinanimals
shallberequired.
6.12.2.Mechanisticstudy—anystudiesnecessarytoclarifyeffectsreportedintoxicitystudies
6.13.Medicaldatainanonymousform.
6.13.1.Medicalsurveillancedataonmanufacturing plantpersonnelifavailable.
6.13.2.Directobservation,e.g.clinicalcases,poisoningincidentsifavailable.
6.13.3.Healthrecords,bothfromindustryandanyotheravailabesources
6.13.4.Epidemiological studiesonthegeneralpopulation,ifavailable.
6.13.5.Diagnosisofpoisoning(determinationofactivesubstance,metabolitesinbodyfluidsorexhaled
air)specificsignsofpoisoning,clinicaltests.
6.13.6.Sensitifcation/allergenicityobservations,ifavailable.
6.13.7.Proposedtreatment:firstaidmeasures,antidotes,medicaltreatment.

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/23
6.13.8.Prognosisfollowingpoisoning .
6.14.Summaryofmammaliantoxicologyandconclusions,includingnoobservableadverseeffectlevel
(NOAEL),noobservableeffectlevel(NOEL),overallevaluationwithregardtoalltoxicological
dataandanyotherinformationconcerningactivesubstance.Wherepossibleanysuggested
workerprotectionmeasuresshouldbeincludedinsummaryform.
VIIECOTOXICOLOGICAL STUDIESONTHEACTIVESUBSTANCE
7.1.Acutetoxicitytofish.
7.2.AcutetoxicitytoDaphniamagna.
7.3.Growthinhibitiontestonalgae.
7.4.Acutetoxicitytestononeother,non-aquatic,non-targetorganism.
7.5.Iftheresultsoftheecotoxicological studiesandtheintendeduse(s)oftheactivesubstance
indicateadangerfortheenvironmentthenthetestsdescribedinAnnexIV,PartsBandC,shall
berequired.
Fateandbehaviourintheenvironment
7.6.Degradation .
7.6.1.•Biotic.
7.6.1.1.Readybiodegradability .
7.6.1.2.Inherentbiodegradability ,whereappropriate .
7.6.1.3.Iftheresultofthetestinpoint7.6.1.2isnegativeandifthelikelyrouteofdisposaloftheactive
substanceanditspreparations isbysewagetreatment,thenthetestdescribedinAnnexIV,
PartC,point4.1shallberequired.
7.6.1.4.Anyotherbiodegradability teststhatarerelevantfromtheresultsinpoints7.6.1.1and7.6.1.2.
7.6.2.Abiotic.
7.6.2.1.HydrolysisasafunctionofpHandidentificationofbreakdownproduct(s).
7.6.2.2.Phototransformation inwaterincludingidentityoftheproductsoftransformation (').
7.6.2.3.Phototransformation inair(estimationmethod),includingidentificationofbreakdown
products(').
7.6.3.Iftheresultsofpoint7.6.1.2or7.6.1.4indicatetheneedtodoso,ortheactivesubstancehasan
overallloworabsentabioticdegradation,thenthetestsdescribedinAnnexIV,PartB,points
1.1and2.1,andwhereappropriatethetestsdescribedinAnnexIV,PartB,point3shallbe
required.
7.7.Adsorption/desorptionscreeningtest.
Wheretheresultsofthistestindicatetheneedtodoso,thetestdescribedinAnnexIV,PartB,
point1.2shallberequired,and/orthetestdescribedinAnnexIV,PartB,point2.2.
7.8.Summaryofecotoxicological effectsandfateandbehaviourintheenvironment .
VIIIMEASURES NECESSARY TOPROTECTMAN,ANIMALSANDTHEENVIRONMENT
8.1.Recommended methodsandprecautionsconcerninghandling,use,storage,transportorfire.
8.2.Incaseoffire,natureofreactionproducts,combustiongasesetc.
(')Thesedatamustbesubmittedforthepurifiedactivesubstanceofstatedspecification .

I
NoC239/24 OfficialJournaloftheEuropeanCommunities 3.9.93
8.3.
8.4.Emergencymeasuresincaseofanaccident.
Possibilityofdestructionordecontamination followingreleaseinoronthefollowing:
\
(a)air;
(b)water,includingdrinkingwater;
(c)soil.
SubstancesfallingwithinthescopeofListIorListIIoftheAnnextoDirective80/68/EECon
theprotectionofgroundwateragainstpollutioncausedbycertaindangeroussubstances(OJNo
L20,26.1.1980,p.43).
Proceduresforwastemanagementoftheactivesubstanceforindustryorprofessionalusers.
i
Possibilityofre-useorrecycling.
Possibilityofneutralization .
Conditionsforcontrolleddischargeincludingleachatequalitiesondisposal.
Conditionsforcontrolledincineration .
i
Others,ifappropriate .8.5.
8.6.
8.6.1.
8.6.2.
8.6.3.
8.6.4.
8.6.5.
IXCLASSIFICATION ANDLABELLING
Proposalsincludingjustificationfortheproposalsfortheclassificationandlabellingoftheactivesubstance
accordingtoDirective67/548/EEC.
—Hazardsymbol(s).
—Indicationsofdanger.
—Riskphrases.
—Safetyphrases.
XSUMMARY ANDEVALUATION OFIITOIX
PARTB
Fungi,icro-organis sandviruses
1.Dossiersonactiveorganismsarerequiredtoaddressatleastallthepointslistedunder'Dossier
requirements'below.Responsesarerequiredtobesupportedbydata.
<
2.Informationwhichisnotnecessaryowingtothenatureofthebiocidalproductorofitsproposeduses
neednotbesupplied.Thesameapplieswhereitisnotscientificallynecessaryortechnicallypossibleto
supplytheinformation .Insuchcases,ajustification,acceptabletothecompetentauthoritymustbe
submitted .
Dossierrequirements
IApplicantsdetails
IIIdentityofactiveorganism
IIISourceofactiveorganism
IVMethodsofdetectionandidentification
VBiologicalpropertiesofactiveorganismincludingpathogenicityandinfectivityfortargetand
non-targetorganismsincludingman

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/25
VIEffectiveness andintendeduses
VIIToxicologicalprofileformanandanimalsincludingmetabolismoftoxins
VIIIEcotoxicological profileincludingenvironmentalfateandbehaviouroftheorganismsandoftoxinsit
produces
IXMeasuresnecessarytoprotectman,non-targetorganismandtheenvironment
XClassificationandlabelling
XISummaryandevaluationofIItoX
Thefollowingdatawillberequiredtosupportsubmissionsontheabovepoints.
IAPPLICANT
1.1.Applicant(name,address,etc.).
s
1.2.Manufacturer (name,address,plantlocation).
IIIDENTITYOFTHEORGANISM
a
2.1.Commonnameoforganism(includingalternativeandsupersedednames).
2.2.Taxonomicnameandstrainindicatingwhetheritisastockvariantoramutantstrain;for
viruses,taxonomicdesignationoftheagent,serotype,strainormutant.
2.3.Collectionandculturereferencenumberwherethecultureisdeposited.
2.4.Methods,proceduresandcriteriausedtoestablishthepresenceandidentityoftheorganism(e.g.
morphology,biochemistry,serology,etc.).
IllSOURCEOFTHEORGANISM
3.1.Occurrenceinnatureorotherwise .
3.2.Isolationmethodsfororganismoractivestrain.
/
3.3.Culturemethods.
i
3.4.Productionmethodsincludingdetailsofcontainmentandproceduretomaintainqualityand
ensureauniformsourceofactiveorganism.Formutantstrainsdetailedinformationshouldbe
providedonproductionandisolation,togetherwithallknowndifferencesbetweenthemutant
strainsandparentandnaturallyoccurringstrains.
3.5.Compositionofthefinalactiveorganismmateriali.e.nature,purity,identity,properties,content
ofanyimpuritiesandextraneousorganisms.
3.6.Methodstopreventcontaminationofseedstockandlossofvirulenceofseedstock.
3.7.Proceduresforwastemanagement .
i
IVMETHODS OFDETECTION ANDIDENTIFICATION
4.1.Methodsforestablishingthepresenceandidentityoftheorganism.
4.2.Methodsforestablishingtheidentityandpurityofseedstockfromwhichbatchesareproduced
andresultsobtained,includinginformationonvariability.

NoC239/26 OfficialJournaloftheEuropeanCommunities 3.9.93
4.3.Methodstoshowmicrobiological purityofthefinalproductandshowingthatcontaminants
havebeencontrolledtoanacceptablelevel,resultsobtainedandinformationonvariability.
4.4.Methodsusedtoshowthattherearenohumanorothermammalianpathogensascontaminants
intheactiveagent,includinginthecaseofprotozoaandfungi,theeffectsoftemperature(35°C
andotherrelevanttemperatures).
4.5.Methodstodetermineviableandnon-viable(e.g.toxins)residuesinorontreatedproducts,
foodstuffs,feedingstuffs,animalandhumanbodyfluidsandtissues,soil,waterandair,where
relevant.
VBIOLOGICAL PROPERTIES OFTHEORGANISM
»
5.1.Historyoftheorganismanditsusesincludingasfarasisknownitsgeneralnaturalhistoryand
ifrelevantitsgeographicaldistribution .
5.2.Relationshiptoexistingpathogensofvertebrates,invertebrates,plantsorotherorganisms.
5.3.Effectsontargetorganism.Pathogenicityorkindofantagonismtothehost.Detailsofhost
specificityrangeshouldbeincluded.
5.4.Transmissibility ,infectivedoseandmodeofactionincludinginformationonpresence,absence
orproductionoftoxicswith,ifappropriate,informationontheirnature,identity,chemical
structureandstabilityandpotency.
5.5.Possibleeffectsonnon-targetorganismscloselyrelatedtothetargetorganismincludinginfec­
tivity,pathogenicity ,transmissibility .
5.6.Transmissibility toothernon-targetorganisms.
It
5.7.Anyotherbiologicaleffectsonnon-targetorganismswhenproperlyused.
5.8.Infectivityandphysicalstabilitywhenproperlyused.
5.9.Geneticstabilityunderenvironmentalconditionsofproposeduse.
5.10.Anypathogenicityandinfectivitytomanandanimalsunderconditionsofimmunosuppression .
5.11.Pathogenicityandinfectivityforknownparasites/predatorsofthetargetspecies.
VIEFFECTIVENESS ANDINTENDED USES
J
6.1.Harmfulorganismscontrolledandmaterials,substances,organismsorproductstobetreatedor
protected.
<
6.2.Usesenvisagede.g.insecticidedisinfectant,anti-foulingbiocide,etc.
\
6.3.Informationorobservationsonundesirableorunintendedsideeffects.
<
6.4.Informationontheoccurrenceorpossibleoccurrenceofthedevelopmentofresistanceand
possiblemanagementstrategiestodealwiththis.
6.5.Effectsontargetorganisms.
6.6.Categoryofuser.
VIITOXICOLOGICAL ANDMETABOLIC STUDIES
7.1.Acutetoxicity.
Incaseswhereasingledoseisnotappropriate,asetofrangefindingtestsmustbecarriedoutto
revealhighlytoxicagentsandinfectivity:
(1)oral;
(2)dermal;

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/27
(3)inhalation;
(4)skinandwherenecessaryeyeirritation;
(5)skinsensitizationandwherenecessaryrespiratorysentization;and
(6)forvirusesandviroids,cellculturestudiesusingpurifiedinfectivevirusandprimarycell
culturesofmammalian,avianandfishcells.
7.2.Sub-chronictoxicity
40-daystudy,twospecies,onerodent,onenon-rodent :
(1)oraladministration ;
(2)otherroutes(inhalation,dermal)asappropriate;and
(3)forvirusesandviroidstestforinfectivitycarriedoutbybio-assayoronasuitablecellculture
atleastsevendaysafteradministrationtotestanimals.
7.3.Chronictoxicity
Twospecies,rodentandoneothermammal,oraladministration unlessotherroutemoreappro
priate.
7.4.Carcinogenicity study
Maybecombinedwithstudiesinpoint6.3.Onerodentandonothermammal
7.5.Mutagenicitystudies
AsspecifiedinPartA,point6.6
7.6.Reproductivetoxicity
Teratogenicity test—rabbitandonerodentspecies.Fertilitystudy—onespecies,minimumtwo
generations,maleandfemale.
7.7.Metabolismstudies
Basictoxicokinetics ,absorption(includingdermalabsorption)distributionandexcretionin
mammalsincludingelucidatipnofmetabolicpathways;
7.8.Neurotoxicity studies:requiredwherethereisanyindicationofanticholinerterase activityor
otherneurotoxiceffects.Delayedneurotoxicitytestsusingadulthensshouldbeperformedwhere
appropriate .
7.9.Immunotoxicity studiese.g.allergenicity
7.10.Incidentalexposurestudies:requiredwheretheactivesubstancewillbeinproductsforusewhere
humanfoodoranimalfeedingstuffsareprepared,consumedorstoredandwherehumans
livestockorpetsarelikelytobeexposedtotreatedareasormaterials.
7.11.Humanexposuredataincluding:
(1)medicaldatainanonymousform(ifavailable);
(2)healthrecords,medicalsurveillancedataonmanufacturing plantspersonnel(ifavailable);
(3)epidemiological data(ifavailable);
(4)poisoningincidentsdata;
»

NoC239/28 OfficialJournaloftheEuropeanCommunities 3.9.93
(5)poisoningdiagnosis(signs,symptoms)includingdetailsofanyanalyticaltests;
(6)proposedtreatmentofpoisoningandprognoses.
7.12.Summaryofmammaliantoxicology—conclusions(includingNOAEL,NOELandifappro­
priateADI)overallevaluationwithregardtoalltoxicological,pathogenicityandinfectivitydata
andanyotherinformationconcerningtheactiveorganism.Wherepossiblesuggesteduser
protectionmeasuresshouldbeincludedinsummaryform.
VIIIECOTOXICOLOGICAL STUDIES
8.1.Acutetoxicitytofish.
8.2.AcutetoxicitytoDaphniamagna.
8.3.Effectsonalgalgrowth(inhibitiontest)
8.4.Acutetoxicityononeother,non-aquatic,non-targetorganism.
8.5.Pathogenicityandinfectivityforhoneybeesandearthworms .
8.6.Acutetoxicityand/orpathogenicityandinfectivityforothernon-targetorganismsbelievedtobe
atrisk.
8.7.Effects(ifany)onotherfloraandfauna.
8.8.Potentialforindirectcontaminationofareasadjacenttotreatmentareas
/
8.9.Incaseswheretoxinsareproduced,dataasoutlinedinAnnexII,PartA,points7.1to7.5should
beproduced.
Fateandbehaviourintheenvironment
8.10.Spread,mobility,multiplicationandpersistenceinair,soilandwater.
8.11.Incaseswheretoxinsareproduced,dataasoutlinedinAnnexII,PartA,points7.6to7.8.
IXMEASURES NECESSARY TOPROTECTMAN,NON-TARGET ORGANISMS ANDTHE
ENVIRONMENT
9.1.Methodsandprecautions,tobetakenforstorage,handling,transportanduse;orineventoffire
onotherlikelyincident.
9.2.Anycircumstancesorenvironmental conditionsunderwhichtheactiveorganismshouldnotbe
used.
9.3.Thepossibilityofrenderingtheactiveorganismuninfectiveandanymethodfordoingthis.
9.4.Consequencesofthecontaminationofair,soilandwater,particularlydrinkingwater.
9.5.Emergencymeasuresincaseofaccident.
9.6.Proceduresforwastemanagementoftheactiveorganismincludingleachatequalitiesondisposal.
9.7.Possibilityofdestructionordecontamination followingreleaseinorintothefollowing:air,
water,soil,othersifappropriate .

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/29
XCLASSIFICATION ANDLABELLING
ProposalsforallocationtooneoftheriskgroupsoutlinedinArticle2(d)ofDirective90/679/CEE(')
withjustificationsfortheproposal.Togetherwithindicationsontheneedforproductstocarrythe
biohazardsignspecifiedinAnnexIIof90/679/EEC.
XISUMMARY ANDEVALUATION OFIITOX
(')OJNoL374,31.12.1990,p.1.
ANNEXIII
s
REQUIREMENTS FORTHEDOSSIERTOBEINTRODUCED FORTHEAUTHORIZATION OF
ABIOCIDALPRODUCT
V
PARTA
Chemicalproducts
1.Dossiersonbiocidalproductsarerequiredtoaddressatleastallthepointslistedunder'Dossiers
requirements'.Responsesarerequiredtobesupportedbydata.
2.Informationwhichisnotnecessaryowingtothenatureofthebiocidalproductorofthisproposeduses
neednotbesupplied.Thesameapplieswhereitisnotscientificallynecessaryortechnicallypossibleto
supplytheinformation .Insuchcases,ajustification,acceptabletothecompetentauthoritymustbe
submitted .
Dossierrequirements
IApplicant
IIIdentityandcompositionofthebiocidalproduct
IIIPhysical,chemicalandtechnicalpropertiesofthebiocidalproduct
IVMethodsforidentificationandanalysisofthebiocidalproduct
VIntendedusesoftheproductandefficacyfortheseuses
VIToxicologydataforthebiocidalproducts(additionaltothatfortheactivesubstance)
VIIEcotoxicological dataforthebiocidalproducts(additionaltothatfortheactivesubstance)
VIIIMeasurestobeadoptedtoprotectman,animalsandtheenvironment
/
IXClassification ,packagingandlabellingofthebiocidalproduct
«
XSummaryandevaluationofIItoIX
Thefollowingdatawillberequiredtosupportsubmissionsontheabovepoints.
IAPPLICANT
/
1.1.Applicant(nameandaddressetc).
1.2.Manufacturerofthepreparationandtheactivesubstance(s)(namesandaddresses,including
locationofpiant(s)).

NoC239/30 OfficialJournaloftheEuropeanCommunities 3.9.93
IIIDENTITYOFTHEBIOCIDALPRODUCT
i
2.1.Tradenameorproposedtradename,andmanufacturer'sdevelopmentcodenumberoftheprepa­
ration,ifappropriate .
2.2.Detailedquantitativeandqualitativeinformationonthecompositionofthepreparatione.g.active
substance(s),impurities,adjuvants,inertcomponents .
2.3.Physicalstateandnatureofthepreparation,e.g.emulsifiableconcentrate,wettablepowder,
solution.
IllPHYSICAL ,CHEMICALANDTECHNICAL PROPERTIES OFTHEBIOCIDALPRODUCT
3.1.Appearance(physicalstate,colour).
3.2.Explosiveproperties.
3.3.Oxidizingproperties.
3.4.Flashpointandotherindicationsofflammabilityorspontaneousignition.
3.5.Acidity/alkalinityandifnecessarypHvalue(1%inwater).
3.6.Relativedensity.
3.7.Storagestability—stabilityandshelf-life.Effectsoflight,temperatureandhumidityontechnical
characteristicsofthebiocidalproduct.
3.8.Technicalcharacteristicsofthepreparation .
3.8.1.Wettability .
9
3.8.2.Persistentfoaming.
3.8.3.Flowability,pourabilityanddustability .
3.8.4.Suspensibilityandsuspensionstability.
3.8.5.Wetsievetestanddrysievetest.
3.8.6.Particlesizedistribution,contentofdust/fines,attritionandfriability.
3.8.7.Inthecaseofgranules,sievetestandindicationofweightdistributionofthegranules,atleastof
thefractionwithparticlesizesbiggerthan1mm.
3.8.8.Emulsifiability ,re-emulsifiability ,emulsionstability.
3.8.9.Wetting,adherenceanddistributiontotargetorganisms.
3.9.Physicalandchemicalcompatibilitywithotherproductsincludingotherbiocidalproductswith
whichitsuseistobeauthorized .
3.10.Ifthebiocidalproductistobeusedintheformofabaitforgranules,thenspecifyanyrepellants
orpoisoncontrolmeasuresincludedwiththepreparationthatarepresenttopreventaction
againstnon-targetorganisms.
IVMETHODS OFIDENTIFICATION ANDANALYSIS
4.1.Analyticalmethodfordeterminingthecompositionofthebiocidalproduct
4.2.InsofarasnotcoveredbyAnnexII,point4.2analyticalmethodsincludingrecoveryratesandthe
limitsofdetermination fortoxicologically andecotoxicologically relevantcomponentsofthe
biocidalproductand/orresiduesthereof,whererelevantinoronthefollowing:
(a)soil;
(b)air;
\
(c)water(includingdrinkingwater);
(d)animalandhumanbodyfluidsandtissues;
(e)treatedfoodorfeedingstuffs .

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/31
VINTENDED USESANDEFFICACY
5.1.Fieldofuseenvisaged.
5.2.Methodofapplication .
5.3.Applicationrateandifappropriate,thefinalconcentration ofbiocidalproductandactive
substanceinsystemsinwhichthepreparationistobeused,e.g.coolingwater,surfacewater,
waterusedforheatingpurposes.
5.4.Numberandtimingofapplications,andwhererelevant,anyparticularinformationrelatingto
geographicalvariations,climaticvariations,ornecessarywaitingperiodstoprotectmanand
livestock.
5.5.Anyothernecessaryinformation .
5.6.Function,e.g.fungicide,rodenticide,insecticide,bacteriocide .
5.7.Pestorganism(s)controlledandproducts,organismsorobjectstobeprotected.
5.8.Effectsontargetorganisms,e.g.contact,ingestionorstomachpoison,fungitoxic,fungistatic .
5.9.ModeofactioninsofarasnotcoveredbyAnnexII,point5.4.
5.10.User,professionalornon-professional .
5.11.Observationsonundesirableorunintendedside-effects,e.g.onbeneficialandothernon-target
organisms .
Efficacydata
5.12.Datatosupporttheefficacyclaimsofthepreparationlabel,includinganyavailablestandard
protocolsused,laboratorytests,orwhereappropriatefieldtrials.Foreachapplicationareasoned
casewillberequired.
5.13.Theeffectoffactorssuchasclimate,temperature,humidity,precipitationetc.insofarasnot
coveredbypoint5.4.
5.14.Compatibilitywithdifferentculturalpracticesandothermeasuresthatmaybeusedagainstthe
targetorganismundertheconditionsofuseenvisaged.
5.15.Anyotherknownlimitationsonefficacy.
5.16.Relativeadvantagesofthepreparationoritsintendedusecomparedtoanyexistingpreparations
ortreatmentmethods.
5.17.Summaryandevaluationofdatapresentedunderpoint5.12to5.17.
VITOXICOLOGICAL STUDIES
6.1.Acutetoxicity.
6.1.1.Oral.
6.1.2.Dermal.
6.1.3.Inhalation .
6.1.4.Skinandeyeirritation.

NoC239/32 OfficialJournaloftheEuropeanCommunities 3.9.93
6.1.5.Forbiocidalproductsthatareintendedtobeauthorizedforusewithotherbiocidalproducts,the
mixtureofpreparations,wherepossible,shallbetestedforacutedermaltoxicityandskinandeye
irritation,asappropriate .
6.2.Dermalabsorptiontest,wherenecessary.
6.3.Availabletoxicologicaldatarelatingtotoxicologically relevantnon-activesubstances.
6.4.Studiesrelatedtotheexposureofthepreparationtoman.
r
Wherenecessary,thetest(s)describedinAnnexIV,PartAshallberequiredforthetoxico­
logicallyrelevantnon-activesubstancesofthepreparation .
6.5.Ifthebiocidalproductisintheformofabaitorgranules,petorlivestockacceptancestudiesmay
berequired.
6.6.Summaryandevaluationofdatapresentedinpoint6.1to6.6,includingwherepossibleany
suggestedworkerprotectionmeasuresinsummaryform.
VIIECOTOXICOLOGICAL STUDIESONTHEBIOCIDALPRODUCT
v
7.1.Theinformationprovidedmust,whererelevant,includethatreferredtoinAnnexII,points7.1
to7.4.
r
7.2.Iftheresultsoftheecotoxicological studiesandtheintendeduse(s)oftheactivesubstance
indicateadangerfortheenvironmentthenthetestsdescribedinAnnexIV,PartsDandEshall
berequired.
Fateandbehaviourintheenvironment
7.3.Theinformationprovidedmust,whererelevant,includethatreferredtoinAnnexII,point7.6.
VIIIMEASURESTOBEADOPTEDTOPROTECTMAN,ANIMALSANDTHEENVIRONMENT
8.1.Recommended methodsandprecautionsconcerninghandling,use,storage,transportorfire.
8.2.Emergencymeasuresincaseofanaccident.
8.3.Procedures,ifany,forcleaningapplicationequipment.
8.4.Possibleroutesofentryintotheenvironment .
8.5.Identityofrelevantcombustionproductsincasesoffire.
8.6.Proceduresforwastemanagementofthebiocidalproductanditspackagingforindustry,
professionalusersandthegeneralpublic.
8.6.1.Possibilityofre-useorrecycling.
8.6.2.Possibilityofneutralization .
8.6.3.Conditionsforcontrolleddischarge.
8.6.4.Conditionsforcontrolledincineration .
8.6.5.Others,ifappropriate .
8.7.Possibilityofdestructionordecontamination followingreleaseinoronthefollowing:
(a)air;
(b)water,includingdrinkingwater;
(c)soil.

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/33
8.8.Leachatequalitiesondisposal,insofarasnotcoveredbypoint8.6.3ofAnnexII.
8.9.Anyinformationonauthorizationinothercountries.
IXCLASSIFICATION ,PACKAGING ANDLABELLING
ProposalsincludingjustificationfortheclassificationandlabellingaccordingtoPirective88/379/EECor,
inthecaseofrodenticides,insecticides/acaricides,avicidesandmolluscicidesDirective78/631/EEC:
r
—hazardsymbol(s),
—indicationsofdanger,
—riskphrases,
—safetyphrases,
—instructionsforuse,
—packaging(type,materials,sizeetc.),compatibilityofthepreparationwithproposedpackaging f
materialstoinclude,
—specimensoftheproposedpackagingandoftheproposedlabel(s)ifsorequired.
XSUMMARY ANDEVALUATION OFALLANNEXIIIINFORMATION AND
REQUIREMENTS
\
PARTB
Fungi,micro-organisms andviruses
1.Dossiersonbiocidalproductsarerequiredtoaddressatleastallthepointslistedunder'Dossier
requirements'.Responsesarerequiredtobesupportedbydata.
2.Informationwhichisnotnecessaryowingtothenatureofthebiocidalproductorofitsproposeduses
neednotbesupplied.Thesameapplieswhereitisnotscientificallynecessaryortechnicallypossibleto
supplytheinformation .Insuchcases,ajustificationacceptabletothecompetentauthoritymustbe
submitted.
Dossierrequirements
IApplicant
IIIdentityandcompositionofthebiocidalproduct
IIITechnicalpropertiesofthebiocidalproductandanybiocidalpropertiesadditionaltothoseofthe
activeorganism
IVMethodsforidentificationandanalysisofthebiocidalproduct
VIntendedusesandefficacyforthoseuses
VIToxicologicalinformation(additionaltothatfortheactiveorganism)
VIIEcotoxicological information(additionaltothatfortheactiveorganism)
VIIIMeasurestobeadoptedtoprotectman,non-targetorganismsandtheenvironment
IXClassification ,packagingandlabellingofthebiocidalproduct
XSummaryofIItoIX

NoC239/34 OfficialJournaloftheEuropeanCommunities 3.9.93
Thefollowingdatawillberequiredtosupportsubmissionontheabovepoints.
IAPPLICANT
1.1.Nameandaddressetc.
1.2.Manufacturers ofbiocidalproductsandactiveorganismsincludinglocationofplants.
IIIDENTITYOFBIOCIDALPRODUCT
2.1.Tradenameorproposedtradenameandmanufacturer'sdevelopmentcodenumberforthe
biocidalproduct,ifappropriate.
2.2.Detailedquantitativeandqualitativeinformation,onthecompositionofthebiocidalproduct
(activeorganisms,inertcomponents,extraneousorganisms,etc.).
2.3.Physicalstateandnatureofthebiocidalproduct(emulsifiableconcentrate,wettablepowder,etc.).
>
2.4.Concentrationofactiveorganisminmaterialused.
IIITECHNICAL ANDBIOLOGICAL PROPERTIES
3.1.Appearance(colourandodour).
3.2.Storage—stabilityandshelf-life.Effectsoftemperature,methodofpackagingandstorage,etc.
onretentionofbiologicalactivity.
3.3.Methodsforestablishingstorageandshelf-lifestability.
3.4.Technicalcharacteristicsofthepreparation .
3.4.1.Wettability.
3.4.2.Persistentfoaming.
3.4.3.Suspensibilityandsuspensionstability.
3.4.4.Wetsievetestanddrysievetest.
3.4.5.Particlesizedistribution,contentofdust/fines,attritionandfriability.
3.4.6.Inthecaseofgranules,sievetestandindicationsofweightdistributionofthegranules,atleastof
thefractionwithparticlesizesbiggerthan1mm.
3.4.7.Contentofactivesubstanceinoronbaitparticles,granulesortreatedmaterial.
3.4.8.Emulsinability ,re-emulsifiability ,emulsionstability.
3.4.9.Flowability,pourabilityanddustability.
3.5.Physicalandchemicalcompatibilitywithotherproductsincludingbiocidalproductswithwhichits
useistobeauthorized .
3.6.Wetting,adherenceanddistributionfollowingapplication.
3.7.Anychangestobiologicalpropertiesoftheorganismisaresultofformulation .Inparticular
changesinpathogenicityoninfectivity.
IVMETHODFORIDENTIFICATION ANDANALYSISOFTHEBIOCIDALPRODUCT
4.1.Analyticalmethodsfordeterminingthecompositionofthebiocidalproduct.
4.2.Methodsfordeterminingresidues(e.g.biotest).«
4.3.Methodsusedtoshowmicrobiological purityofthebiocidalproduct.

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/35
4.4.Methodsusedtoshowthebiocidalproducttobefreefromanyhumanandothermammalian
pathogensor,ifneedbe,frompathogensharmfultonon-targetorganismsandtheenvironment .
4.5.Techniquesusedtoensureauniformproductandassaymethodsforitsstandardization .
VINTENDED USESANDEFFICACYFORTHESEUSES
5.1.Use.
Producttype(e.g.woodpreservative,publichygienebiocideetc).
5.2.Detailsofintendeduse,e.g.typesofharmfulorganismcontrolled,materialstobetreatedetc.
5.3.Applicationrate.
5.4.Wherenecessary,inthelightofthetestresults,anyspecificcircumstancesorenvironmental
conditionsunderwhichtheproductmayormaynotbeused.
5.5.Methodofapplication.
t
5.6.Numberandtimingofapplications .
*
5.7.Proposedinstructionsforuse.
s
I
Efficacydata
j
5.8.Preliminaryrange-findingtests.
5.9.Fieldexperimentation .
5.10.Informationonthepossibleoccurrenceofthedevelopmentofresistance.
5.11.Effectsonthequalityofmaterialsorproductstreated.
VITOXICITYINFORMATION ADDITIONAL TOTHATREQUIREDFORTHEACTIVE
ORGANISM
6.1.Oralsingledose.
6.2.Percutaneoussingledose.
6.3.Inhalation .
6.4.4
Skinandwhererelevanteyeirritation.
6.5.Skinsensitization .
6.6.Availabletoxicologicaldatarelatingtonon-activesubstances.
6.7.Operatorexposure.
6.7.1.Percutaneousabsorption/inhalationdependingonformulationandmethodofapplication.
6.7.2.Likelyoperatorexposureunderfieldconditions,includingwhererelevantquantitativeanalysisof
operatorexposure.
VIIECOTOXICITY INFORMATION ADDITIONAL TOTHATREQUIREDFORTHEACTIVE
ORGANISM
7.1.Observationsconcerningundesirableorunintendedside-effects,e.g.onbeneficialandother
non-targetorganismsorpersistenceintheenvironment .

1.Foodandfeedingstuffsstudies
1.1.Identificationofdegradationandreactionproductsandofmetabolitesoftheactivesubstancein
treatedorcontaminated foodsorfeedstuffs .
1.2.Behaviouroftheresidueoftheactivesubstance,itsdegradationproductsandwhererelevantits
metabolitesonthetreatedorcontaminatedfoodorfeedstuffsincludingthekineticsofdisap­
pearance.
1.3.Overallmaterialbalanceoftheactivesubstance.Sufficientresiduedatafromsupervisedtrialsto
demonstratethatresidueslikelytoarisefromproposedusewouldnotbeofconcernforhumanor
animalhealth.NoC239/36 OfficialJournaloftheEuropeanCommunities 3.9.93
VIIIMEASURESTOBEADOPTEDTOPROTECTMAN,NON-TARGET ORGANISMS AND
THEENVIRONMENT
8.1.Recommended methodsandprecautionsconcerninghandling,storage,transportanduse.
r
8.2.Re-entryperiods,necessarywaitingperiodsorotherprecautionstoprotecthumansandanimals.
8.3.Emergencymeasuresincaseofanaccident.
8.4.Proceduresfordestructionordecontamination ofthebiocidalproductanditspackaging.
8.5.Proceduresforcleaningapplicationequipment .
8.6.Proceduresforsafedisposaloftheconcentratedbiocidalproductordilutedproduct.
IXCLASSIFICATION ,PACKAGING ANDLABELLING
9.1.Proposalsincludingjustificationfortheclassification,packagingandlabelling
(i)withregardtonon-biological componentsoftheproductinaccordancewithDirective
88/379/EEC:
—hazardsymbol(s),
—indicationsofdanger,
—riskphrases,
—safetyphrases;
(ii)withregardtotheactiveorganismslabellingwiththeappropriateriskgroupasoutlinedin
Article2(d)ofDirective90/679/EECtogetherwiththebiohazardsignspecifiedinthat
Directiveifappropriate .
9.2.Packaging(type,materials,size,etc.),compatibilityofthepreparationwithproposedpackaging
materials.
9.3.Specimensofproposedpackaging.
I
XSUMMARY OFIITOIX
ANNEXIV
FURTHERREQUIREMENTS FORTHEDOSSIERSTOBEINTRODUCED FORTHEAUTH­
ORIZATION OFBIOCIDALPRODUCTS
<
PARTA
>
Furtherhumanhealthrelatedstudiesontheactivesubstanceand/orthepreparation

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/37
1.4.Estimationofpotentialoractualexposureoftheactivesubstancetohumansthroughdietand
othermeans.
1.5.Iftheresidueofthebiocidalproductremainsonfeedingstuffsforasignificantperiodoftimethen
feedingandmetabolismstudiesinlivestockshallberequiredtopermitevaluationofresiduesin
foodofanimalorigin.
1.6.Effectsofindustrialprocessingand/ordomesticpreparationonthenatureandmagnitudeof
residueofthebiocidalproductoractivesubstance.
1.7.Proposedacceptableresiduesandthejustificationoftheiracceptability .
1.8.Anyotheravailableinformationthatisrelevant.
1.9.Summaryandevaluationofdatasubmittedunder1.1to1.8.
2.Othertest(s)relatedtotheexposuretoman
Suitabletest(s)andareasonedcasewillberequiredfortheactivesubstanceorthepreparation,as
appropriate .
PARTB
Furtherstudiesonthefateandbehaviouroftheactivesubstanceintheenvironment
1.Fateandbehaviourinsoil
1.1.Rateandrouteofdegradationincludingidentificationoftheprocessesinvolvedandidentification
ofanymetabolitesanddegradationproductsinatleastthreesoiltypesunderappropriate
conditions .
1.2.Adsorptionanddesorptioninatleastthreesoiltypesandwhererelevantadsorptionand
desorptionofmetabolitesanddegradationproducts.
1.3.Mobilityinatleastthreesoiltypesandwhererelevantmobilityofmetabolitesanddegradation
products.
1.4.Extentandnatureofboundresidues.
k
2.Fateandbehaviourinwater
2.1.Rateandrouteofdegradationinaquaticsystems(asfarasisnotcoveredbyAnnexII,point7.6)
includingidentificationofmetabolitesanddegradationproducts.
2.2.Adsorptionanddesorptioninwater(soilsedimentsystems)andwhererelevantadsorptionand
desorptionofmetabolitesanddegradationproducts.
3.Fateandbehaviourinair
V
Iftheactivesubstanceistobeusedinpreparationsforfumigants,ifitistobeappliedbyaspray
method,ifitisvolatile,orifanyotherinformationindicatesthatthisisrelevant,thentherateand
routeofdegradationinairshallbedeterminedasfarasisnotcoveredbyAnnexII,point7.6.2.3.
4.Summaryandevaluationofparts1,2and3
PARTC
Furtherecotoxicological studiesontheactivesubstance
1.Effectsonbirds
1.1.Acuteoraltoxicity—thisneednotbedoneifanavianspecieswasselectedforstudyinAnnexII,
point7.4.
>
1.2.Short-termtoxicity—eight-daydietarystudyinatleastonespecies(otherthanchicken).
1.3.Effectsonreproduction .

NoC239/38 OfficialJournaloftheEuropeanCommunities 3.9.93
2.Effectsonaquaticorganisms
2.1.Prolongedtoxicitytoanappropriatespeciesoffish.
2.2.Effectsonreproductionandgrowthrateonanappropriatespeciesoffish.
2.3.Bioaccumulation inanappropriatespeciesoffish.
2.4.Daphniamagnareproductionandgrowthrate.
3.Effectsonothernon-targetorganisms
3.1.Acutetoxicitytohoneybeesandotherbeneficialarthropodse.g.predators.Adifferenttest
organismshallbechosenfromthatusedinAnnexII,point7.4.
i
3.2.Toxicitytoearthwormsandtoothersoilnon-targetmacro-organisms .
«
«
3.3.Effectsonsoilnon-targetmicro-organisms .
3.4.Effectsonanyotherspecific,non-targetorganisms(floraandfauna)believedtobeatrisk.
*
4.Othereffects
4.1.Activatedsludgerespirationinhibitiontest.
5.Summaryandevaluationofparts1,2and3.
I
PARTD
Furtherstudiesonthefateandbehaviouroftheenvironmentally relevantcomponentsofthebiocidal
productintheenvironment
1.WhererelevantalltheinformationrequiredinAnnexIV,PartB.
2.Testingfordistributionanddissipationinthefollowing:
(a)soil;
(b)water;
(c)air.
Testrequirements 1and2areapplicableonlytoecotoxicologically relevantcomponentsofthepreparation .
PARTE
Furtherecotoxicological studiesonthebiocidalproducts
1.Effectsonbirds
1.1.Acuteoraltoxicity,ifnotalreadydoneinaccordancewithAnnexIII,point7.
2.Effectsonaquaticorganisms
i
2.1.Incaseofapplicationon,inorneartosurfacewaters.
2.1.1.Particularstudieswithfishandotheraquaticorganisms.
2.1.2.Residuedatainfishconcerningtheactivesubstanceandincludingtoxicologically relevantmetab­
olites.
2.1.3.ThestudiesreferredtoinAnnexIV,PartCpoints2.1,2.2,2.3and2.4mayberequiredfor
relevantcomponentsofthepreparation .
2.2.Ifthebiocidalproductistobesprayedneartosurfacewatersthenanoverspraystudymaybe
requiredtoassessriskstoaquaticorganismsunderfieldconditions.

3.9.93 OfficialJournaloftheEuropeanCommunities NoC239/39
3.
3.1.
3.2.Effectsonothernon-targetorganisms
Toxicitytoterrestrialvertebratesotherthanbirds.
Acutetoxicitytohoneybees.
Effectsonbeneficialarthropodsotherthanbees.
Effectsonearthwormsandothersoilnon-targetmacro-organisms ,believedtobeatrisk.3.3.
3.4.
3.5.
3.6.Effectsonsoilnon-targetmicro-organisms .
Effectsonanyotherspecific,non-targetorganisms(floraandfauna)believedtobeatrisk,
Ifthebiocidalproductisintheformofbaitorgranules,thefollowingwillberequired. 3.7.
3.7.1.Supervisedtrialstoassessriskstonon-targetorganismsunderfieldconditions.
3.7.2Studiesonacceptancebyingestionofthebiocidalproductbyanynon-targetorganismsthought
tobeatrisk;insofarasnotcoveredbyAnnexIII,point6.6.
4.SummaryandevaluationofParts1,2and3.
ANNEXV
Biocidalproductsshallincludethoseproducttypessetoutbelowwhichcanbeusedforthepurposes
described:
Producttype Descriptionofuse
Disinfectant Disinfectionofskin(humanoranimal)andarticles
intendedtocomeintocontactwithskin.
Disinfectionofwaterusedforpublicbathing. Swimmingpooldisinfectant
Foodindustrydisinfectant
Generalbiocide
Sanitarybiocide
Air-conditioning biocide
WoodpreservativesDisinfectionofcontainerssurfacesandpipework
associatedwiththeproductionoffoodanddrinkfor
humansandanimals.
Controlofharmfulmicro-organisms inpremises
vehiclesandareasusedbyhumansandanimals.
Controlofharmfulmicro-organisms insanitary
convenanciesandequipment .
Controlofharmfulorganismsinairconditioning
systems.
Protectionofsawntimberandtimberproductsfrom
harmfulorganisms.
Protectionoftextilesfromharmfulorganisms.
Protectionofmasonryandotherconstruction
materials(exceptwood)fromharmfulorganisms.
Protectionofproductsmarketedtotheconsumer,
otherthanfoodandfeed,fromharmfulorganisms.
Controlofharmfulorganismsaffectingindustrial
processes.
Controlofharmfulorganismsinconnectionwith
specificproducts,substances,materials,articleson
areasnotcoveredbyotherproducttypes.Textilepreservatives
Masonrypreservatives
Consumerproductpreservatives
Industrialbiocides
Specialistbiocides

NoC239/40 OfficialJournaloftheEuropeanCommunities 3.9.93
Producttype
Rodenticide
AvicideDescriptionofuse
Controlofrats,miceorotherrodentsforpurposes
ofpublichealthandwell-being.
Controlofbirdsforpurposesofpublichealthand
well-being.
Controlofsnailsandothermolluscs,bothterrestrial
andaquaticforpurposesofpublichealthandwell­
being.
Controlofinsects,mitesandotherarthropodsfor
purposesofpublichealthandwell-being.Molluscicide
Insecticide/Acaricide
Anti-foulingbiocide Controloffoulingorganismsonships,boats,aquatic
structuresandarticles.