6.10.95 1EN1OfficialJournaloftheEuropeanCommunities NoC261/5
II
(PreparatoryActs)
COMMISSION
AmendedproposalforaEuropeanParliamentandCouncilDirectiveconcerningtheplacingof
biocidalproductsonthemarket(')
(95/C261/03)
(TextwithEEArelevance)
COM(95)387final—COD465
(SubmittedbytheCommissionpursuanttoArticle189a(2)oftheECTreatyon24July1995)
OOJNoC239,3.9.1993,p.3.
ORIGINALPROPOSAL MODIFIED PROPOSAL
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,THEEUROPEAN PARLIAMENT ANDTHECOUNCIL
OFTHEEUROPEANUNION,
HavingregardtotheTreatyestablishingtheEuropean HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity,andinparticularArticle100aCommunity,andinparticularArticle100athereof,
thereof,
HavingregardtotheproposalfromtheCommission,HavingregardtotheproposalfromtheCommission,
IncooperationwiththeEuropeanParliament, delete
HavingregardtotheopinionoftheEconomicand
SocialCommittee,HavingregardtotheopinionoftheEconomicand
SocialCommittee,
Actinginaccordancewiththeprocedurelaiddownin
Article189boftheTreaty
(newrecital13a)
Whereasitisnecessarytoprovidecommonrulesforthe
evaluationandauthorization ofbiocidalproductsto
ensureaharmonizedapproachbyMemberStates

NoC261/6EN OfficialJournaloftheEuropeanCommunities 6.10.95
ORIGINAL PROPOSAL MODIFIED PROPOSAL
Article4(1)(b) Article4(1)(b)
(b)Itisestablished,inthelightofcurrentscientificand
technicalknowledgeanditisshownfromappraisal
ofthedossierprovidedforinAnnexIIIand,where
specified,therelevantpartsofAnnexIVaccording
tothecommonprinciplesfortheevaluationof
dossiers,thatwhenusedasauthorizedandhaving
regardto:(b)Itisestablished,inthelightofcurrentscientificand
technicalknowledgeanditisshownfromappraisal
ofthedossierprovidedforinAnnexIIIand,where
specified,therelevantpartsofAnnexIVaccording
tothecommonprinciplesfortheevaluationof
dossiersaslaiddowninAnnexVI,thatwhenused
asauthorizedandhavingregardto:
—allnormalconditionsunderwhichthebiocidal
productmaybeused,—allnormalconditionsunderwhichthebiocidal
productmaybeused,
—howthematerialtreatedwithitmaybeused, —howthematerialtreatedwithitmaybeused,
—theconsequencesfromuseanddisposal, —theconsequencesfromuseanddisposal,
thebiocidalproduct: thebiocidalproduct:
(i)issufficientlyeffective; (i)issufficientlyeffective;
(ii)hasnounacceptableeffectonthetargetorganism;(ii)hasnounacceptableeffectonthetargetorganism;
(iii)hasnoharmfuleffectsitselforasaresultofits
residues,onhumanoranimalhealth,directlyor
indirectly(egthroughdrinkingwater,foodorfeed)
orongroundwater ;(iii)hasnoharmfuleffectsitselforasaresultofits
residues,onhumanoranimalhealth,directlyor
indirectly(egthroughdrinkingwater,foodorfeed)
orongroundwater ;
(iv)hasnounacceptableeffectontheenvironment
havingparticularregardtothefollowing
considerations :(iv)hasnounacceptableeffectontheenvironment
havingparticularregardtothefollowing
considerations :
—itsfateanddistributionintheenvironment ;
particularlycontaminationofwaterincluding
drinkingwaterandgroundwater ,—itsfateanddistributionintheenvironment ;
particularlycontamination ofwaterincluding
drinkingwaterandgroundwater,
—itsimpactonnon-targetorganisms; —itsimpactonnon-targetorganisms;
(v)doesnotcauseunnecessarysufferingandpainto
vertebratestobecontrolled,(v)doesnotcauseunnecessarysufferingandpainto
vertebratestobecontrolled,

6.10.95 1ËN!OfficialJournaloftheEuropeanCommunities NoC261/7
ORIGINALPROPOSAL MODIFIEDPROPOSAI ,
Article26 Article26
Commonprinciplesfortheevaluationofdossiers delete
Thecommonprinciplesforevaluationofdossiers
referredtoinArticle(4)(1)(b)above,shallbeadopted
inaccordancewiththeprocedurelaiddowninArticle25
(3).Theseprinciplesshallberegularlyreviewedand
whereappropriaterevised,inaccordancewiththesame
procedure .
Article27
AdaptationtotechnicalprogressArticle27
Adaptationtotechnicalprogress
TheamendmentsnecessaryforadaptingAnnexesII,III,
IVandVtotechnicalprogressshallbeadoptedin
accordancewiththeprocedurelaiddowninArticle25
(3).TheamendmentsnecessaryforadaptingAnnexesII,III,
IV,VandVItotechnicalprogressshallbeadoptedin
accordancewiththeprocedurelaiddowninArticle25
(3).
ANNEXVI
(new)
COMMONPRINCIPLES FORTHEEVALUATION OFDOSSIERS
Definitions
(a)Hazardidentification
Thisistheidentificationoftheadverseeffectswhichabiocidalproducthasaninherentcapacityto
cause.
(b)Dose(concentration)—response(effect)assessment
Thisistheestimateoftherelationshipbetweenthedose,orlevelofexposure,ofanactivesubstanceor
substanceofconcerninabiocidalproductandtheincidenceandseverityofaneffect.
(c)Exposureassessment
Thisisthedeterminationoftheemissions,pathwaysandratesofmovementofanactivesubstanceora
substanceofconcerninabiocidalproductanditstransformation ordegradationinordertoestimate
theconcentration/dosestowhichhumanpopulations,animalsorenvironmental compartments areor
maybeexposed.
(d)Riskcharacterization
Thisistheestimationoftheincidenceandseverityoftheadverseeffectslikelytooccurinahuman
population,animalsorenvironmentalcompartmentsduetoactualorpredictedexposuretoanyactive
substanceorsubstanceofconcerninabiocidalproduct.Thismayinclude'riskestimation',i.e.the
quantificationofthatlikelihood.
(e)Substanceofconcem
Anysubstance,otherthantheactivesubstance,whichhasaninherentcapacitytocauseanadverse
effectonhumans,animalsortheenvironmentandispresentorisproducedinabiocidalproductin
sufficientconcentrationtomanifestsuchaneffect.Suchasubstance,unlessthereareothergroundsfor
concern,wouldnormallybeasubstanceclassifiedasdangerousaccordingtoDirective67/548/EEC
andpresentinthebiocidalproductataconcentrationleadingtheproducttoberegardedasdangerous
withinthemeaningofArticle3ofDirective88/379/EEC.

NoC261/8EN OfficialJournaloftheEuropeanCommunities 6.10.95
(f)Animais
Animalsbelongingtospeciesnormallyfedandkeptorconsumedbyhumans.
Introduction
1.ThisAnnexlaysdownprinciplestoensurethatevaluationsmadeanddecisionstakenbyaMember
Stateconcerningtheauthorizationofabiocidalproductresultsinaharmonizedhighlevelof
protectionforhumans,animalsandtheenvironmentinaccordancewithArticle4(1)(b)ofthe
Directive .
2.Inordertoensureahighandharmonizedlevelofprotectionofhumanandanimalhealthandofthe
environment ,anyrisksarisingfromtheuseofabiocidalproductshallbeidentified.Toachievethisa
riskassessmentshallbecarriedouttodeterminetheacceptabilityorotherwiseofanyrisksidentified
duringtheproposednormaluseofthebiocidalproduct.
3.TheMemberStateshallalwayscarryoutariskassessmentontheactivesubstanceorsubstances
presentinthebiocidalproduct.Thisriskassessmentshallentailhazardidentification ,and,asappro­
priate,dose(concentration )—response(effect)assessment,exposureassessmentandriskcharacter­
ization.Whereaquantitativeriskassessmentcannotbemadeaqualitativeassessmentshallbe
produced .
4.Additionalriskassessmentsshallbecarriedout,inthesamemannerasdescribedabove,onanyother
substanceofconcernpresentinthebiocidalproductwhererelevantfortheuseofthebiocidalproduct.
5.Inordertocarryoutariskassessmentdataarerequired.ThesedataaredetailedinAnnexesII,IIIand
IVand,recognizingthatthereareawidevarietyofproducttypes,areflexibleaccordingtothe
producttypeandassociatedrisks.Thedatarequiredshallbetheminimumnecessarytocarryoutan
appropriateriskassessment .MemberStatesshouldtakedueconsiderationoftherequirementsof
Articles11and12inordertoavoidduplicationofdatasubmissions .Theminimumsetofdatarequired
foranactivesubstanceinanybiocidalproducttype,however,shallbethatdetailedinAnnexVIIAof
Directive67/548/EEC.Datamayalsoberequiredonasubstanceofconcernpresentinabiocidal
product.
6.Theresultsoftheriskassessmentscarriedoutonanactivesubstanceandonasubstanceofconcern
presentinthebiocidalproductshallbeintegratedtoproduceanoverallassessmentforthebiocidal
productitself.
7.Whenmakingevaluationsandtakingdecisionsconcerningtheauthorizationofabiocidalproductthe
MemberStateshall:
(a)takeintoconsiderationotherrelevanttechnicalorscientificinformationwhichisreasonably
availabletothemwithregardtothepropertiesofthebiocidalproduct,itscomponents,metab­
olites,orresidues;
(b)evaluate,whererelevant,justificationssubmittedbytheapplicantfornotsupplyingcertaindata.
8.TheMemberStateshallcomplywiththerequirementsofmutualrecognitionasstatedinArticles3(3)
and3(4)oftheDirective.
9.Itisknownthatmanybiocidalproductspresentonlyminordifferencesincompositionandthisshould
betakenintoaccountwhenevaluatingdossiers.
10.TheapplicationofthesecommonprinciplesshallleadtotheMemberStatedecidingwhetherornota
biocidalproductcanbeauthorized,suchauthorizationmayincluderestrictionsonuseorother
conditions.IncertaincasestheMemberStatemayconcludethatmoredataarerequiredbeforean
authorization decisioncanbemade.
11.Duringtheprocessofevaluationanddecision-making ,aMemberStateshallcooperatewiththe
applicantinordertoresolveanyquestionsonthedatarequirementsquicklyortoidentifyatanearly
stageanyadditionalstudiesrequired,ortoamendanyproposedconditionsfortheuseofthebiocidal
productortomodifyitsnatureoritscompositioninordertoensurefullcompliancewiththe
requirementsofthisAnnexorofthisDirective.Theadministrativeburden,especiallyforSMEs,shall
bekepttotheminimumnecessarywithoutprejudicingthelevelofprotectionaffordedtohumansand
theenvironment .

6.10.95 |EN1OfficialJournaloftheEuropeanCommunities NoC261/9
12.ThejudgementsmadebytheMemberStateduringtheevaluationanddecisionmakingprocessmustbe
basedonscientificprinciples,preferablyrecognizedatinternationallevel,andbemadewiththebenefit
ofexpertadvice.
Evaluation
Generalprinciples
13.Thedatasubmittedinsupportofanapplicationforauthorizationofabiocidalproductshallbe
examinedforcompletenessandoverallscientificvaluebythereceivingMemberState.Afteracceptance
ofthesedatatheMemberStateshallutilizethembycarryingoutariskassessmentbasedonthe
proposeduseofthebiocidalproduct.
14.Ariskassessmentontheactivesubstancepresentinthebiocidalproductshallalwaysbecarriedout.If
thereare,inaddition,anysubstancesofconcernpresentinthebiocidalproductthenariskassessment
shallbecarriedoutforeachofthese.Theriskassessmentshallcovertheproposednormaluseofthe
biocidalproducttogetherwithareasonablyforeseeableworstcasescenario.
15.Foreachactivesubstanceandeachsubstanceofconcernpresentinthebiocidalproduct,therisk
assessmentshallentailahazardidentificationandtheestablishmentofappropriateno-effectlevels
wherepossible.Itshallalsoinclude,asappropriate,adose(concentration )—response(effect)
assessment,togetherwithanexposureassessmentandariskcharacterization .
16.Theresultsarrivedatfromacomparisonoftheexposuretotheno-effectlevelconcentrations foreach
oftheactivesubstancesandanysubstancesofconcernshallbeintegratedtoproduceanoverallrisk
assessmentforthebiocidalproduct.Wherequantitativeresultsarenotavailabletheresultsofthe
qualitativeassessmentsshallbeintegratedinasimilarmanner.
17.Theriskassessmentshalldetermine :
(a)therisktohumansandanimals;
(b)therisktotheenvironment ;
(c)themeasuresnecessarytoprotecthumans,animalsandthegeneralenvironmentduringboththe
proposednormaluseofthebiocidalproductandinarealisticworstcasesituation.
18.Incertaincasesitmaybeconcludedthatfurtherdataarerequiredbeforeariskassessmentcanbe
finalized.Anysuchadditionaldatarequestedshallbetheminimumnecessarytocompletesucharisk
assessment .
Effectsonhumans
19.Theriskassessmentshalltakeaccountofthefollowingpotentialeffectsarisingfromtheuseofthe
biocidalproductandthepopulationsliabletoexposure.
20.Theeffectspreviouslymentionedresultfromthepropertiesoftheactivesubstanceandanysubstance
ofconcernpresent.Theyare:
—acutetoxicity,
—irritation,
—corrosivity,
—sensitization ,
—repeateddosetoxicity,
—mutagenicity ,
—carcinogenicity ,
—reproductiontoxicity,
—anyspecialpropertiesduetotheactivesubstanceorsubstanceofconcernbeingamicro-organism ,
fungusorvirus,
—othereffectsduetophysico-chemical properties .
21.Thepopulationspreviouslymentionedare:
—professionals ,
—non-professionals ,
—humansexposedindirectlyviatheenvironment .

NoC261/10PEN OfficialJournaloftheEuropeanCommunities 6.10.95
22.Thehazardidentificationshalladdressthepropertiesandpotentialadverseeffectsoftheactive
substanceandanysubstancesofconcernpresentinthebiocidalproduct.Ifthisresultsinthebiocidal
productbeingclassifiedaccordingtotherequirementsoftheDirectivethendose(concentration )—
response(effect)assessment,exposureassessmentandriskcharacterization shallberequired.
23.Inthosecaseswherethetestappropriatetohazardidentificationinrelationtoaparticularpotential
effectofanactivesubstanceorasubstanceofconcernpresentinabiocidalproducthasbeen
conductedbuttheresultshavenotledtoclassificationofthebiocidalproductthenriskcharacter­
izationinrelationtothateffectshallnotbenecessaryunlessthereareotherreasonablegroundsfor
concern.Thegenerationofunacceptableresidueswouldbeanexampleofreasonablegroundsfor
concern .
24.TheMemberStateshallapplypoints25to28whencarryingoutadose(concentration )—response
(effect)assessmentonanactivesubstanceorasubstanceofconcernpresentinabiocidalproduct.
25.Forrepeateddosetoxicityandreproductivetoxicitythedoseresponserelationshipshallbeassessedfor
eachactivesubstanceorsubstanceofconcernand,wherepossible,theno-observed-adverse-effect level
(NOAEL)identified.IfitisnotpossibletoidentifyanNOAEL,thelowest-observed-adverse-effect
level(LOAEL)shallbeidentified.
26.Foracutetoxicity,corrosivityandirritation,itisnotusuallypossibletoderiveanNOAELorLOAEL
onthebasisoftestsconductedinaccordancewiththerequirementsoftheDirective.Foracute
toxicity,theLD50orLC50valueor,wherethefixeddoseprocedurehasbeenused,thediscriminating
doseshallbederived.Fortheothereffectsitshallbesufficienttodeterminewhethertheactive
substanceorsubstanceofconcernhasaninherentcapacitytocausesucheffectsduringuseofthe
product.
27.Formutagenicityandcarcinogenicity itshallbesufficienttodeterminewhethertheactivesubstanceor
substanceofconcernhasaninherentcapacitytocausesucheffectsduringuseofthebiocidalproduct.
However,ifitcanbedemonstratedthatanactivesubstanceorasubstanceofconcernidentifiedasan
carcinogenisnon-genotoxic ,itwillbeappropriatetoidentifyaN(L)OAELasdescribedinparagraph
25.
28.Withrespecttoskinsensitizationandrespiratorysensitization,insofarasthereisnoconsensusonthe
possibilityofidentifyingadose/concentrationbelowwhichadverseeffectsareunlikelytooccurina
subjectalreadysensitizedtoagivensubstance,itshallbesufficienttoevaluatewhethertheactive
substanceorsubstanceofconcernhasaninherentcapacitytocausesucheffectsduringuseofthe
biocidalproduct.
29.Wheretoxicitydataderivedfromobservationsofhumanexposure,e.g.informationgainedfrom
manufacture ,frompoisoncentresorepidemiologysurveys,areavailablespecialconsiderationshallbe
giventothosedatawhencarryingouttheriskassessment .
30.Anexposureassessmentshallbecarriedoutforeachofthehumanpopulations(professionals ,
non-professionals andhumansexposedindirectlyviatheenvironment)forwhichexposuretoabiocidal
productoccursorcanreasonablybeforeseen.Theobjectiveoftheassessmentshallbetomakea
quantitativeorqualitativeestimateofthedose/concentrationofeachactivesubstanceorsubstanceof
concerntowhichapopulationisormaybeexposedduringuseofthebiocidalproduct.
31.Theexposureassessmentshallbebasedontheinformationinthetechnicaldossierprovidedin
conformitywithArticle7oftheDirectiveandonanyotheravailableandrelevantinformation .
Particularaccountshallbetaken,asappropriate,of:
—adequatelymeasuredexposuredata,
—theforminwhichtheproductismarketed,
—thetypeofbiocidalproduct,
—theapplicationmethodandapplicationrate,
—thephysico-chemical propertiesoftheproduct,
—thelikelyroutesofexposureandpotentialforabsorption,
—thefrequencyanddurationofexposure,
—thetypeandsizeofspecificexposedpopulationswheresuchinformationisavailable.

6.10.95[JN]OfficialJournaloftheEuropeanCommunities NoC261/11
32.Whereadequatelymeasured,representativeexposuredataareavailable,specialconsiderationshallbe
giventothemwhenconductingtheexposureassessment .Wherecalculationmethodsareusedforthe
estimationofexposurelevels,adequatemodelsshallbeapplied.Thesemodelsshall:
—makeabestpossibleestimationofallrelevantprocessestakingintoaccountrealisticparameters
andassumptions ,
—besubmittedtoananalysistakingintoaccountpossibleelementsofuncertainty,
—bereliablyvalidatedwithmeasurementscarriedoutundercircumstancesrelevantfortheuseofthe
model,
—berelevanttotheconditionsintheareaofuse.
Relevantmonitoringdatafromsubstanceswithanalogoususeandexposurepatternsoranalogous
propertiesshallalsobeconsidered .
33.Where,foranyoftheeffectssetoutin20aNOAELorLOAELhadbeenidentified,theriskcharac­
terizationshallentailcomparisonoftheNOAELorLOAELwiththeevaluationofthedose/concen­
trationtowhichthepopulationwillbeexposed.WhereaNOAELorLOAELhasnotbeenestablished
aqualitativecomparisonshallbemade.
Effectsonanimais
34.Usingthesamerelevantprinciplesasdescribedinthesection'EffectsonHumans',theMemberState
shallconsidertherisksposedtoanimalsfromthebiocidalproduct.
35.DatashallbesubmittedtoandevaluatedbytheMemberStatetoassesswhetherthebiocidalproductis
humaneinitseffectontargetvertebrates .Thisshallincludeanevaluationofthemechanismbywhich
theeffectisobtainedandtheobservedeffectsonthebehaviourandhealthofthetargetvertebrates;
wheretheintendedeffectistokillthetargetvertebratethetimenecessarytoobtainthedeathofthe
targetvertebrateandtheconditionsunderwhichdeathoccursshallbeevaluated.
Effectsontheenvironment
36.Theriskassessmentshalltakeaccountofanyadverseeffectsarisinginanyofthe3environmental
compartments—air,soilandwater(includingsediment),followingtheuseofthebiocidalproduct.
37.Thehazardidentification shalladdressthepropertiesandpotentialadverseeffectsoftheactive
substanceandanysubstancesofconcernpresentinthebiocidalproduct.Ifthisresultsinthebiocidal
productbeingclassifiedaccordingtotherequirementsoftheDirectivethen(concentration )—
response(effect)assessment,exposureassessmentandriskcharacterization shallberequired.
38.Inthosecaseswherethetestappropriatetohazardidentificationinrelationtoaparticularpotential
effectofanactivesubstanceorasubstanceofconcernpresentinabiocidalproducthasbeen
conductedbuttheresultshavenotledtoclassificationofthebiocidalproductthenriskcharacter­
izationinrelationtothateffectshallnotbenecessaryunlessthereareotherreasonablegroundsfor
concern.Suchgroundsmayderivefromthepropertiesandeffectsofanyactivesubstanceorsubstance
ofconcerninthebiocidalproduct,inparticular :
—anyindicationsofbioaccumulation potential,
—thepersistencecharacteristics ,
—theshapeofthetoxicity/timecurveinecotoxicitytesting,
—indicationsofotheradverseeffectsonthebasisoftoxicitystudies(e.g.classificationasamutagen),
—dataonstructurallyanalogoussubstances .
39.Adose(concentration)—response(effect)assessmentshallbecarriedoutinordertopredictthe
concentration belowwhichadverseeffectsintheenvironmental compartmentofconcernarenot
expectedtooccur.Thisshallbecarriedoutfortheactivesubstanceandforanysubstanceofconcern
presentinthebiocidalproduct.Thisconcentration isknownasthepredictedno-effectconcentration
(PNEC).However,insomecases,itmaynotbepossibletoestablishaPNECandqualitativeesti­
mationofthedose(concentration)—response(effect)thenhastobemade.

NoC261/12[EN]OfficialJournaloftheEuropeanCommunities 6.10.95
40.ThePNECshallbedeterminedfromthedataoneffectsonorganismsandecotoxicitystudies
submittedinaccordancewiththerequirementsofArticle7oftheDirective.Itshallbecalculatedby
applyinganassessmentfactortothevaluesresultingfromtestsonorganisms,e.g.LD50(medianlethal
dose),LC50(medianlethalconcentration),EC50(medianeffectiveconcentration),IC50(concentration
causing50%inhibitionofagivenparameter,e.g.growth),NOEL(C)(no-observed-effect level
(concentration)),orLOEL(C)(lowest-observed-effect level(concentration)).
41.Anassessmentfactorisanexpressionofthedegreeofuncertaintyinextrapolationfromtestdataona
limitednumberofspeciestotherealenvironment .Therefore,ingeneral,themoreextensivethedata
andthelongerthedurationofthetests,thesmalleristhedegreeofuncertaintyandthesizeofthe
assessmentfactor.
42.Foreachenvironmental compartmentanexposureassessmentshallbecarriedoutinordertopredict
theconcentrationlikelytobefoundofeachactivesubstanceorsubstanceofconcernpresentinthe
biocidalproduct.Thisconcentration isknownasthepredictedenvironmental concentration (PEC).
HoweverinsomecasesitmaynotbepossibletoestablishaPECandaqualitativeestimateofexposure
thenhastobemade.
43.APEC,orwherenecessaryaqualitativeestimateofexposure,needonlybedeterminedforthe
environmentalcompartmentstowhichemissions,discharges,disposalordistributionsareknownorare
reasonablyforeseeable .
44.ThePEC,orqualitativeestimationofexposure,shallbedeterminedtakingaccountof,inparticular,
andifappropriate :
—adequatelymeasuredexposuredata,
—theforminwhichtheproductismarketed,
—thetypeofbiocidalproduct,
—theapplicationmethodandapplicationrate,
—thephysico-chemical properties,
—breakdown/transformation products,
—likelypathwaystoenvironmentalcompartmentsandpotentialforadsorption/desorptionanddegra­
dation,
—thefrequencyanddurationofexposure.
45.Whereadequatelymeasured,representativeexposuredataareavailable,specialconsiderationshallbe
giventothemwhenconductingtheexposureassessment .Wherecalculationmethodsareusedforthe
estimationofexposurelevels,adequatemodelsshallbeapplied.Thecharacteristicsofthesemodels
shallbeaslistedinparagraph32.Whereappropriate,onacasebycasebasis,relevantmonitoringdata
fromsubstanceswithanalogoususeandexposurepatternsoranalogouspropertiesshallalsobe
considererd .
46.Foranygivenenvironmentalcompartment ,theriskcharacterization shall,asfaraspossible,entail
comparisonofthePECwiththePNECsothataPEC/PNECratiomaybederived.
47.IfithasnotbeenpossibletoderiveaPEC/PNECratio,theriskcharacterization shallentailaquali­
tativeevaluationofthelikelihoodthataneffectisoccurringunderthecurrentconditionsofexposure
orwilloccurundertheexpectedconditionsofexposure.
Unacceptableeffects
48.TheMemberStateshall,whererelevant,evaluatethepossibilityofthedevelopmentofresistancetoan
activesubstanceinthebiocidalproductbythetargetorganism.
49.IfthereareindicationsthatanyotherunacceptableeffectsmayoccurtheMemberStateshallevaluate
thepossibilityofsucheffectsoccurring.Anexampleofsuchanunacceptableeffectwouldbean
adversereactiontofasteningsandfittingsusedinwoodfollowingtheapplicationofawood
preservative .
Efficacy
50.Datashallbesubmittedandevaluatedtoascertainiftheefficacyclaimsofthebiocidalproductcanbe
substantiated .DatasubmittedbytheapplicantorheldbytheMemberStatemustbeabletodemon­
stratetheefficacyofthebiocidalproductagainstthetargetorganismswhenusednormallyin
accordancewiththeconditionsofauthorization .

6.10.95 |EN|OfficialJournaloftheEuropeanCommunities NoC261/13
51.TestingshouldbecarriedoutaccordingtoEuropeanUnionguidelinesiftheseareavailableand
applicable.Intheabsenceoftheseothermethodscanbeusedasshowninthelistbelowwhichisin
orderofdescendingpreference :
—ISO,CENorotherinternationalstandard,
—nationalstandard,
—industrystandard(acceptedbyMemberState),
—individualproducerstandard(accpetedbyMemberState),
—datafromtheactualdevelopmentofthebiocidalproduct.
Summary
52.Ineachoftheareaswhereriskassessmentshavebeencarriedout,i.e.effectsonman,animals,andthe
environment ,theMemberStateshallcombinetheresultsfortheactivesubstancetogetherwiththe
resultsforanysubstanceofconcerntoproduceanoverallassessmentforthebiocidalproductitself.
Thisshouldtakeaccountofanylikelysynergisticeffectsoftheactivesubstance(s)andsubstancesof
concerninthebiocidalproduct.
53.Forbiocidalproductscontainingmorethanoneactivesubstanceanyadverseeffectsshallalsobe
combinedtoproduceanoveralleffectforthebiocidalprocuctitself.
Decisionmaking
GeneralPrinciples
54.TheMemberStateshallcometoadecisionregardingtheauthorizationforuseofabiocidalproduct
asaresultoftheintegrationoftherisksarisingfromeachactivesubstancetogetherwiththerisksfrom
eachsubstanceofconcernpresentinthebiocidalproduct.Theriskassessmentsshallcovernormaluse
ofthebiocidalproducttogetherwitharealisticworstcasescenario.
55.InmakingadecisionconcerningauthorizationtheMemberStateshallarriveatoneofthefollowing
conclusionsforeachproducttypeandforeachareaofuseofthebiocidalproductforwhich
applicationhasbeenmade:
1,thebiocidalproductcannotbeauthorized;
2,thebiocidalproductcanbeauthorizedsubjecttospecificconditions/restrictions;
3,moredataisrequiredbeforeadecisiononauthorizationcanbemade.
56.IftheconclusionarrivedatbytheMemberStateisthatadditionalinformationordataarerequired
beforeanauthorizationdecisioncanbemadethentheneedforanysuchinformationordatashallbe
justified.Thisadditionalinformationordatashallbetheminimumnecessarytocarryoutafurther
appropriateriskassessment .
57.TheMemberStateshallcomplywiththeprinciplesofmutualrecognitionasdetailedinArticle3ofthe
Directive .
58.TheMemberStateshallrecognizetheconceptof'frameformulations'whenmakinganauthorization
decisiononabiocidalproduct.
59.TheMemberStateshallonlygrantauthorizationtothosebiocidalproductswhich,whenused
accordingtotheirconditionsofauthorization ,donotpresentanunacceptablerisktohumans,animals
ortheenvironment ,areefficaciousandwhichcontainactivesubstancespermittedatCommunitylevel
tobeusedinsuchbiocidalproducts.
Inthecaseofactivesubstancesnotonthemarketontheimplementation dateoftheDirectiveonly
thosesubstanceslistedinAnnexIoftheDirectivecanbeusedinbiocidalproducts.
60.TheMemberStateshallimpose,whereappropriate,conditionsorrestrictionswhengivingauthor­
izations.Thenatureandseverityoftheseshallbeselectedonthebasisof,andbeappropriateto,the
natureandextentoftheexpectedadvantagesandtheriskslikelytoarisefromtheuseofthebiocidal
product.

NoC261/14EN]OfficialJournaloftheEuropeanCommunities 6.10.95
61.InthedecisionmakingprocesstheMemberStateshalltakeintoconsiderationthefollowing:
—theresultsoftheriskassessment,inparticulartherelationshipbetweenexposureandeffect,
—thenatureandseverityoftheeffect,
—theriskmanagementwhichcanbeapplied,
—thefieldofuseofthebiocidalproduct,
—theefficacyofthebiocidalproduct,
—thephysicalpropertiesofthebiocidalproduct,
—thebenefitsofusingthebiocidalproduct.
62.TheMemberStateshall,whentakingadecisionconcerningtheauthorizationofabiocidalproduct,
takeintoaccounttheuncertaintyarisingfromthevariabilityinthedatausedintheevaluationand
decisionmakingprocess.
63.TheMemberStateshallprescribethatbiocidalproductsshallbeusedproperly.Properuseshall
includeapplicationatanefficaciousdoseandminimizationofuseofbiocidalproductswherepossible.
64.BeforeissuinganauthorizationtheMemberStateshallensurethatthelabel,togetherwiththerelevant
safetydatasheet,ofthebiocidalproduct:
—fulfilstherequirementsofArticles18and19oftheDirective,
—containstheinformationontheprotectionofusersrequiredbyCommunitylegislationonworker
protection,
—specifiesinparticulartheconditionsorrestrictionsunderwhichthebiocidalproductmayormay
notbeused.
65.TheMemberStateshallensurethattheproposedpackagingand,whereappropriate,theproposed
proceduresfordestructionordecontamination ofthebiocidalproductanditspackagingarein
accordancewiththerelevantregulatoryprovisions.
Emetsonbumans
66.TheMemberStateshallnotauthorizeabiocidalproductiftheriskassessmentconfirmsthat,in
normaluse,theproductpresentsanunacceptablerisktohumans.
67.TheMemberStateshallconsiderpossibleeffectsonallhumanpopulations,namelyprofessionals ,
non-professionals andhumansexposeddirectlyorindirectlythroughtheenvironmentwhenmakinga
decisionontheauthorizationofabiocidalproduct.
68.TheMemberStateshallexaminetherelationshipbetweentheexposureandtheeffectandusethisin
thedecisionmakingprocess.Anumberoffactorsneedtobeconsideredwhenexaminingthis
relationshipandoneofthemostimportantisthenatureoftheadverseeffectofthesubstance.These
effectsincludeacutetoxicity,irritancy,corrosivity,sensitization ,repeateddosetoxicity,mutagenicity ,
carcinogenicity andreproductiontoxicitytogetherwithphysico-chemical properties.
69.TheMemberStateshall,wherepossible,comparetheresultsobtainedwiththoseobtainedfrom
previousriskassessmentsforanidenticalorsimilaradverseeffectanddecideuponanappropriate
marginofsafetywhenmakinganauthorizationdecision.
70.TheMemberStateshallonlyasalastresortimpose,asaconditionofauthorization ,thewearingof
personalprotectiveequipmentsuchasrespirators,overalls,glovesandgogglesinordertoreduce
exposureforprofessionaloperators.Suchequipmentmustbereadilyavailabletothem.
71.TheMemberStateshallonlyasalastresortimpose,asaconditionofauthorization ,thewearingof
personalprotectiveequipmentasanacceptablemethodforreducingexposurefornon-professional
users.Suchpersonalprotectiveequipmentmustbereadilyavailabletonon-professional usersand
wouldnormallybelimitedtoitemssuchascoveralls,gloves,boots,safetyglassesandgoggles.
72.Iftherelationshipbetweentheexposureandtheeffectcannotbereducedtoanacceptablelevelthen
noauthorizationcanbegivenbytheMemberStateforthebiocidalproduct.

6.10.951ENIOfficialJournaloftheEuropeanCommunities NoC261/15
73.NobiocidalproductclassifiedaccordingtoArticle18(1)oftheDirectiveasverytoxicorasacategory
1or2carcinogenormutagenorclassifiedastoxicforreproductioncategory1or2,shallbeauth­
orizedforusebythegeneralpublic.
Ejjectsonanimais
74.TheMemberStateshallnotauthorizeabiocidalproductiftheriskassessmentconfirmsthat,in
normaluse,thebiocidalproductpresentsanunacceptablerisktoanimals.
75.Usingthesamerelevantcriteriaasdescribedinthesection'EffectsonHumans',theMemberState
shallconsidertherisksposedtoanimalsfromthebiocidalproductwhenmakinganauthorization
decision.
76.Anauthorizationforabiocidalproductintendedtoeliminatevertebratesshallonlybegivenwhen:
—deathissynchronouswiththeextinctionofconsciousness ,or
—deathoccursimmediately ,or
—vitalfunctionsarereducedgraduallywithoutsignsofobvioussuffering.
Forrepellentproducts,theintendedeffectshallbeobtainedwithoutunnecessarysufferingandpainfor
thetargetvertebrate .
Effectsontheenvironment
77.TheMemberStateshallnotauthorizeabiocidalproductiftheriskassessmentconfirmsthattheactive
substanceoranysubstanceofconcernoranydegradationorreactionproductpresentsanunac­
ceptableriskinanyoftheenvironmental compartmentswater(includingsediment),soilandair.This
shallincludetheassessmentofriskstonon-targetorganismsinthesecompartments .
78.ThebasictoolusedinthedecisionmakingisthePEC/PNECratioor,ifthisisnotavailable,a
qualitativeestimation.Dueconsiderationshallbegiventotheaccuracyofthisratioduetovariability
inthedatausedbothinmeasurements ofconcentration andofestimation .
79.ForanygivenenvironmentalcompartmentifthePEÇ/PNECratioisequaltoorlessthanonetherisk
characterization shallbethatnofurtherinformationand/ortestingarenecessary.Iftheratioisgreater
thanonetheMemberStateshalljudge,onthebasisofthesizeofthatratioandonotherrelevant
factors,iffurtherinformationand/ortestingarerequiredtoclarifytheconcernorifriskreduction
measuresarenecessaryoriftheproductcannotbegivenanauthorizationatall.Relevantfactorstobe
consideredarethosepreviouslymentionedinSection38.
Water
80.TheMemberStateshallnotauthorizeabiocidalproductif,undertheproposedconditionsofuse,the
foreseeableconcentrationoftheactivesubstanceorofanyothersubstanceofconcernorofrelevant
metabolitesorbreakdownorreactionproductsingroundwaterexceedsthelowerofthefollowing
concentrations :
(a)themaximumpermissibleconcentration laiddownbyDirective80/778/EECof15July1980
relatingtothequalityofwaterintendedforhumanconsumption ;or
(b)themaximumconcentrationlaiddownbytheCommissionwhenincludingtheactivesubstancein
AnnexI,onthebasisofappropriatedata,inparticulartoxicologicaldata.
81.Noauthorization shallbegrantediftheconcentration oftheactiveingredientorasubstanceof
concernorofrelevantmetabolites,breakdownorreactionproductstobeexpectedafteruseofthe
biocidalproductundertheproposedconditionsofuseinsurfacewater:
—exceeds,wherethesurfacewaterinorfromtheareaofenvisageduseisintendedforthe
abstractionofdrinkingwater,thevaluesfixedbyCouncilDirective75/440/EECof16June1975
concerningthequalityrequiredofsurfacewaterintendedfortheabstractionofdrinkingwaterin
theMemberStates(OJNoL194,25.7.1975,p.34),or
—hasanimpactdeemedunacceptableonnon-targetspecies.
82.Theproposedinstructionsforuseofthebiocidalproduct,includingprocduresforcleaningapplication
equipment,mustbesuchthatthelikelihoodofaccidentalcontaminationofwaterisminimized .

NoC261/16EN OfficialJournaloftheEuropeanCommunities 6.10.95
Sou
83.Wherecontamination ofsoilislikelytooccur,theMemberStateshallnotauthorizeabiocidalproduct
iftheactivesubstanceorsubstanceofconcerncontainedinit,afteruseofthebiocidalproductunder
theproposedconditionsofuse:
—duringtestsinthefield,persistinsoilformorethanoneyear,or
—duringlaboratorytests,formnon-extractable residuesinamountsexceeding70%oftheinitial
doseafter100days,withamineralizationrateoflessthan5%in100days,
unlessitisscientificallydemonstratedthatunderfieldconditionsthereisnounacceptableaccumulation
insoil.
Ar
84.TheMemberStateshallnotauthorizeabiocidalproductwherethereisaforeseeablepossibilityof
unacceptableeffectsontheaircompartment ,e.g.ozonedepletionorcontributiontothegreenhouse
warmingpotential.
Effectsonnon-targetorganisms
85.TheMemberStateshallnotauthorizeabiocidalproductwherethereisareasonablyforeseeablepossi­
bilityofnon-targetterrestrialvertebratesand/orinvertebratesbeingexposedtothebiocidalproductif
foranyactivesubstanceorsubstanceofconcern:
—thePEC/PNECisabove1unlessitisclearlyestablishedintheriskassessmentthatunderfield
conditionsnounacceptableeffectsoccurafteruseofthebiocidalproductaccordingtothe
proposedconditionsofuse;
—thebioconcentration factor(BCF)relatedtofattissuesinnon-targetvertebratesisabove1unlessit
isclearlyestablishedintheriskassessmentthatunderfieldconditionsnounacceptableeffects
occur,eitherdirectlyorindirectly,afteruseoftheproductaccordingtotheproposedconditionsof
use.
86.TheMemberStateshallnotauthorizeabiocidalproductwherethereisareasonablyforeseeablepossi­
bilityofaquaticorganismsbeingexposedtothebiocidalproductifforanyactivesubstanceor
substanceofconcerninit:
—thePEC/PNEC>1unlessitisclearlyestablishedintheriskassessmentthatunderfield
conditionstheviabilityofaquaticorganismsisnotthreatenedbythebiocidalproductaccordingto
theproposedconditionsofuse,
—thebioconcentration factor(BCF)isgreaterthan1000forsubstanceswhicharereadilybiode­
gradableorgreaterthan100forthosewhicharenotreadilybiodegradable unlessitisclearly
establishedintheriskassessmentthatunderfieldconditionsnounacceptableimpact,eitherdirectly
orindirectly,occursontheviabilityofexposedorganismsafteruseofthebiocidalproduct
accordingtotheproposedconditionsofuse.
Unacceptableeffects
87.IfthedevelopmentofresistancetotheactivesubstanceinthebiocidalproductislikelytheMember
Stateshalltakestepstominimizetheconsequencesofthisresistance.Thismayinvolvemodificationof
theconditionsofauthorizationorevenrefusalofanyauthorization .
Efficacy
88.TheMemberStateshallnotauthorizeabiocidalproductwhichisnotefficaciouswhenusedin
accordancewiththeconditionsofauthorization .
89.Thelevel,consistencyanddurationofcontrolorprotectionorotherintendedeffectsmustbesimilar
tothoseresultingfromtheuseofsuitablereferenceproducts.Ifnosuitablereferenceproductexists,
thebiocidalproductmustbeshowntogiveadefinedbenefitintermsofthelevel,consistencyand
durationofcontrolorprotectionorotherintendedeffectsduringnormaluse.

6.10.95LEN]OfficialJournaloftheEuropeanCommunities NoC261/17
Summary
90.Ineachoftheareaswhereriskassessmentshavebeencarriedout,i.e.effectsonhumans,animals,and
theenvironment ,theMemberStateshallcombinetheconclusionsarrivedatfortheactivesubstance
andthesubstancesofconcerntoproduceanoverallconclusionforthebiocidalproductitself.
Overallintegrationofconclusions
91.TheMemberStateshallcombinetheindividualconclusionsarrivedatwithregardtoeffectsofthe
biocidalproductonthethreesectorsnamely,humans,animalsandtheenvironmenttoarriveata
overallconclusionfortheglobaleffectofthebiocidalproduct.
92.TheMemberStateshallthentakedueconsiderationofanyrelevantunacceptableeffects,theefficacy
ofthebiocidalproductandthebenefitsofusingthebiocidalproductbeforetakinganauthorization
decisiononthebiocidalproduct.
93.TheMemberStateshallultimatelydecidewhetherornotthebiocidalproductcanbeauthorizedand
whetherthisauthorizationshallbesubjecttoanyrestrictionsorconditionsinconformitywiththis
AnnexandtheDirective.