Currentlegislativeframework
fornanomaterials:supporting
REACHregulation
NanoMONITOR 1st Stakeholder’sDay
DrNeilHunt
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Contents
• LegislativeframeworkaroundchemicalsintheEU
• NanomaterialsandREACH
•
•
•
•
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Definitionofnanomaterialsandnanoforms
CharacterisationandrecentBoA decision
HazardassessmentofnanomaterialsunderREACH
ExposureassessmentofnanomaterialsunderREACH
RiskassessmentandriskcommunicationofnanomaterialsunderREACH
• NanomaterialsandotherEUregulations
• NationalReportingSchemes
• Conclusion
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
RegulatoryframeworkforchemicalsintheEU
Biocides
Medicinaland
veterinary
products
REACH
Cosmetics
Food
contact
Plant
Protection
Products
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
• Regulationsareusebased.
• REACHcoversallusesnotcovered
byotherregulations.
• Nonano-specificregulation.
• Eachregulationmayrequire
nanomaterialstobeassessed
differentlytobulkforms
Usefuldefinitions
• Nanomaterial(draft):
• Anatural,incidentalormanufacturedmaterialcontainingparticles,inanunbound
stateorasanaggregateorasanagglomerateandwhere,for50%ormoreofthe
particlesinthenumbersizedistribution,oneormoreexternaldimensionsisinthe
sizerange1nm- 100nm.
• Nanoform(ECHA,RIVM,JRC(2016))
• Theterm…….todistinguishformsofasubstancethatfulfiltheECRecommendation
onthedefinitionoftheterm‘nanomaterial’butdifferwithregardtosize
distributions,shapeand/orsurfacechemistry.”
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Reviseddefinitionofnanomaterial
• Areviseddefinitionisbeingdiscussed.
• Largelythesamebutwithsomeimportantchanges.
• Clarificationthatitdoesnotcoverindividualmolecules(macromolecules,dendrimers).
• Notclearwhetherparticleswithadimensionof<1nmwillremainnanomaterialsornot.
• SpecificSurfaceAreaof<5m2/cm3maybeusedtodefinesubstancethatarenot
nanomaterials.
• The50%bynumbersizedistributionmayberegardedasindicativeandothervaluesmight
bemorerelevantincertainsituations.
• Lotsofdebateanddiscussion,sothesemightchange!
• HopefullywillbeinplacebeforeanyrevisionofAnnexXIVtoavoidreplicationof
workforregistrants.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Definitionofnanomaterial– Keypoints
Primaryparticlesinunboundstate
Primaryparticlesasanagglomerate
Primaryparticlesasanaggregate
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
• “particles,inanunboundstateor
asanaggregateorasan
agglomerate”.
• Definitionbasedondimensionsof
primaryparticles
• Agglomeratecanberelativelyeasily
broken,butaggregatesarenoteasy
tobreakintotheirconstituent
primaryparticleswithoutdamaging
particles.
• Isprimaryparticleor
agglomerate/aggregatesizekeyfor
riskassessment?
Definitionofnanomaterial– Keypoints
• 50%ormoreoftheparticlesinthe
numbersizedistribution
• Modalaverageofnumber
distribution
• Cananalyticalmethodsmeasure
numberdistribution?
• Numberdistributionwilllook
differenttovolumeorresponse
distributions.
• Arealotofpowdersgoingtofall
underthedefinitionunexpectedly?
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Definitionofnanomaterial– Keypoints
• Oneormoreexternaldimensionsisinthesizerange1nm- 100nm.
•
•
•
•
Particles,rods,needlesandplatescanallbenanomaterials.
Shortestdimensionisthekeyparameter.
Doanalyticalmethodsmeasurethisdimension?
Nanoscaleporesandspacesdonotdefineananomaterial.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Nanoforms– Interconvertibility
Original primary
particles
Coated (deliberate
or environmental)
particles
Agglomerate
Smaller primary
particles
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grant agreement LIFE14 ENV/ES/000662
Nanoforms– DifficultiesinLifecycleAssessment
• Organicliquidsubstance
• Onlychangeofstateisbetweensolid,liquidandgas.
• Hazardsareintrinsictothesubstance.
• Changesinstatemainlyaffectexposure.
• Nanomaterialpowder
• Differentnanoformsofthesamesubstancemay displaydifferenttoxicological
profiles.
• Differentnanoformsofthesamesubstancemay displaydifferentexposure
behaviours.
• Whichformexistsateachpointinthelifecycle?
• Isthehazard,exposureandriskassessmentappropriateforthenanoform?
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
NanomaterialsandREACH
KeyaspectsofREACH
Thehazardsandrisksarisingfromasubstanceshouldbeknown,andthe
appropriateriskmanagementmeasurescommunicated,forsubstances
manufacturedinorimportedtotheEU.
Toxicological/Ecotoxicological/PhysicalChemicalHazards
identifiedbyoneentity(LeadRegistrant)
Otherregistrantsshouldreceivepermissiontousethis
dataintheirregistrationdossierandensurethatitis
relevanttothesubstancethattheyplaceonthemarket
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
NanomaterialsandREACH
NanomaterialsandREACH
• AspectsofREACHapplytonanomaterialsastootherformsofasubstance.
• Thesameinclusionandexclusioncriteria(polymers,mixtures,exemptions).
• Timetableisthesame.
• Samebasicinformationrequirementsbasedonproductionvolumesofthe
registrants.
• Informationintheregistrationdossiershouldapplytothesubstanceplacedonthe
market.
• Testingshouldbeadaptedtothepropertiesofthesubstance.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
NanomaterialsandREACH
Substanceidentification– GeneralpointsinREACH
• Allsubstancesshouldbeidentifiedbytheirchemicalcomposition.
• Requireidentificationandquantificationofconstituents
• Somesubstancesmaybefurtheridentifiedbyotherparameters(Guidance
foridentificationandnamingofsubstances,Section4.2.3)
• Particlesizementionedasapossibleparameter.
• Whetherornotasubstanceisananomaterialisapossibleparameter.
• Substanceidentificationshouldbesufficienttoassesswhetherthedatain
theregistrationdossierisapplicable.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
NanomaterialsandREACH
ImpactofrecentBoardofAppealdecision
ECHAdecision
• Registrantsof
titaniumdioxide
shouldinclude
detailsofall
nanoformsaspartof
substance
characterisation.
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grant agreement LIFE14 ENV/ES/000662
Industry
(Registrants)Appeal
• Thiswouldmean
nanoformsofa
substancehad
additional
requirementstobulk
forms.Thisisnotin
linewithAnnexVIof
REACH.
BoardofAppeal
(BoA)Decision
• BoA foundinfavour
ofregistrantsBUTit
washighlightedthat
itshouldbeshown
thatdatainthe
dossierisapplicable
tothesubstance
placedonthe
market.
RevisionofAnnexVIofREACH
• AnnexXVIstatesthecharacterisationrequirementsforREACH.
• Currentlyparticlecharacterisationisanoptionnotanobligation.Keyissue
inrecentBoA decision.
• Absenceofparticlecharacterisationmakesdossierandsubstance
evaluationdifficult.
• REACHrevisionscurrentlyestimatedtobeofficiallyinplacein2020.
• Itiscurrentlyexpectedthatparticlecharacterisationtoidentify
nanomaterialsandnanoformswillbemoreprominentinAnnexXVI.
• Thiswillapplytoallpowdersnotonlydeliberatelymanufactured
nanomaterials.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Particlecharacterisationtoidentifynanomaterials
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
DynamicLightScattering
• Usesfluctuationsinscatteredlightcausedbya
particletodeterminehowfasttheparticlemoves
inasuspensionthroughBrownianMotion.
• Advantages:
• Relativelycheapandeasytouse
• Measuresastatisticallysignificantdistributionof
particlesizerelativelyrapidly
• Disadvantages
• Distributionmeasuredbysignalintensityorvolume
NOTnumber
• Doesnotdistinguishagglomerate/aggregatesfrom
primaryparticles
• Measureshydrodynamicradius
• Conclusion
• Goodscreeningtool.
• IfDLSindicatesasampleisananomaterial,italmost
certainlyis!
• Shouldnotbeusedinisolation
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
ParticleCharacterisationofNanomaterials
ElectronMicroscopy(ScanningorTransmission)
• Useelectronbeamstovisualiseparticlesat
magnificationsthatcannotbeachievedusingoptical
microscopy.
• Advantages
• Primaryparticlescanbedistinguishedfrom
agglomerates/aggregates
• Particlesizeandshapecanbemeasured
• Shortestdimensioncanbemeasured
• Disadvantages
• Multipleimagesneededtogiveastatisticallysignificant
samplesize
• Probablyrequiresoperatorinputandjudgementtoidentify
primaryparticles
• Givesa2-Dimageof3-Dobject
• Conclusion
• Essentialtoolforparticlecharacterisation
• Canbeusedtocheckwhetherresultsfromothermethods
canbeusedtomeasureprimaryparticlesizedistribution.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
ParticleTrackingAnalysis
• Tracksscatteredlightpatternscausedby
individualparticles.Usesvelocitythrougha
mediumtocalculateparticlesize.
• Advantages
• Measuresnumberdistribution
• Relativelylowcost
• Canbeusedwithlowconcentrationsamples
• Disadvantages
• Measureshydrodynamicradius
• Cannotdistinguishprimaryparticlesfrom
agglomerates/aggregates
• Conclusion
• Usefultooltodirectlymeasurenumber
distributionofparticles
• Needsmicroscopytoconfirmexactlywhatis
beingmeasured.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
SpecificSurfaceArea(SSA)byBrunauer EmmettTeller(BET)analysis
• CalculatesSSAbymeasuringamountofagasthatcan
beadsorbedontothesurfaceofthesample.
• SSA>60m2/cm3 regardedasindicatinga
nanomaterial.
• SSA<5m2/cm3may beacutoffornot beinga
nanomaterial(newdefinitionofnanomaterial).
• Advantages
• Wellknownmethodwithmanyproviders.Standard
methodsavailable.
• Disadvantages
• Notameasurementofprimaryparticlesizedistribution.
• Internalstructures(pores,tubeinteriors)canbiastowards
highervalues.
• Knowledgeofdensityisrequired.
• Conclusion
• Cannotbeusedinisolationbutisveryusefultosupport
conclusions.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
SamplePreparation
• Samplepreparationkeytomeasuringwhatyouthinkyouaremeasuring.
• Howareagglomeratesbroken?
• Areadditivesrequiredtokeepprimaryparticlesunbound?
• Isthesubstancesoluble/stableinthetechniquemedium?
• Ensureprimaryparticlesarenotdamagedduringtreatment.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
ParticleCharacterisation
• Inmanysituations,nosinglemethodcanbeusedtoproveasubstancea
substanceisananomaterialaccordingtothecurrentdefinition.
• Techniquesshouldbeappropriatetothesubstance.
• Differenttechniquesmightbeappropriateforriskassessment(measuring
particlesizeasitexists).
• Mustbeawareofexactlywhatisbeingmeasured.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
REACHandHazardAssessment
• Testingrequirementsbasedonthetonnageperannumofthesubstance
manufacturedinorimportedintotheEU.
• ClearlydefinedinAnnexesVIItoXofREACH.
• Waiversforsomestudiesavailable.
• Read-across,QSARandgroupingareallpermittedbutmustbescientifically
justified.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
REACHHazardAssessmentofNanomaterials
• Sameendpointsrequiredasforothersubstances.
• Endpointmethodologymightneedtobealteredtoaccountfor
characteristicsofnanomaterials.
• Somewaiversmightnotbeappropriatetouse.
• ComprehensiveguidancegivenbyECHAinAnnexestoguidancedocuments
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
EndpointTestingofNanomaterials
REACHendpointmodifications
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
EndpointTestingofNanomaterials
Intelligenttestingstrategiesfornanomaterials– REACHandbeyond
• Invitro,insilico,QSARandread-acrosswillbevitaltoavoidlargescale
animaltesting.
• Researchongoing
• EUfundedprojects(MARINA,NanoReg,SUNetc.)
• Riskassessmentshouldaccountforchangestonanoformthroughthe
lifecycle.
• Propercharacterisationbothbeforeandduringstudiesessential
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grant agreement LIFE14 ENV/ES/000662
REACHandExposureAssessment
• AllREACHregistrationsrequirecommunicationoftheusesofasubstance.
• Ifthesubstanceishazardousandisregisteredatover10t/a,exposure
scenariosmustbeincludedinaChemicalSafetyReport.
• Exposureisoftenestimatedusingestablishedoccupationaland
environmentalfatemodellingtools.
• Theregistrantmustchoosetheappropriatetool.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
ExposureAssessmentandNanomaterials
• Choosethecorrectnanoformforthelifecyclestage.
• Canstandardtoolsbeappliedtonanomaterials?
• Possiblyforworkerexposureifread-acrosstobulkformscanbeproved.
• Unlikelyforenvironmentalexposureasmosttoolsusepartitionco-efficientasakey
parameter.
• Somenano-specifictoolsavailable
• NanomoduleofStoffenmanger
• SimpleBox4nano
• EUfundedprojectsshouldimprovethechoiceandqualityofmodels.
• Themodelswillneedtobevalidatedagainstmeasureddata.
• NanoMONITOR
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
REACH,RiskAssessmentandCommunication
• Riskismeasuredbyensuringexposureviaagivenrouteislowerthana
calculated“safe”value.
• Ifriskisnotacceptable,appropriateriskmanagementmeasuresshouldbe
implemented.
• Themeasuresrequiredtoensureacceptableriskfromasubstancemustbe
communicatedinexposurescenariosfoundintheannexofanExtended
SafetyDataSheet(eSDS).
• AnyrecipientofaneSDS mustimplementthemeasuresstatedorprovethat
alternativemethodsareequivalentorsuperior.
• Measurementcanalsobeusedtoprovecompliance.
• NanoMONITOR
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
RiskAssessmentandNanomaterials
• RiskAssessmentofbulksubstance.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
• Interconversionanddifferent(eco)toxicologicalprofilesofnanoformsmake
riskassessmentmorecomplex.
RiskAssessmentandNanomaterials
• Hazardofananomaterialisnotintrinsicduetodifferentnanoforms.
• HazardcanbereducedbySafeDesignofthenanomaterial.
• SeeSUNproject.
• Riskmanagementmeasuresshouldbeappropriatetonanomaterial.
• Facemasksshoulduseappropriatefinefilters.
• Settlingtankswithhumates mightbeusefulforon-siteremediationofwastewaters.
• Exposurescenariosfornanomaterialsuncommon.
• SeeMARINAproject(oraskme!).
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
NanomaterialsandotherEUregulations
• BiocidalProductsRegulation
• Anactivesubstanceinananoformmustbeauthorisedseparatelytothesame
substanceinthebulkform.
• CosmeticsRegulation
• Nanomaterialsascosmeticingredientsmustbeassessedseparatelytobulkformsof
thesamesubstanceiftheyperformcertainrolesinthecosmetic.
• Theingredientslistmustshowthatasubstanceexistsasananomaterial.
• FoodContactMaterials
• AnanoformofasubstancecannotberegardedasbeingontheUnionListof
authorisedsubstancesevenifthebulkformisonthelist.
• Assessmentandauthorisationismadeonacasebycasebasis.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Nanomaterialsandotherregulations
• Medicaldevices
• Degreeofriskassessmentrequireddependsonlikelihoodofreleaseof
nanomaterialsfromthedevice.
• US
• OneoffreportingschemetoEPA.
• Australia
• NICNASrevised,mayintroducenewhazardsymbolfor“nanohazard”.
• Mayrequirenewnanospecific hazardstatements.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
NationalRegistriesandVoluntaryNotificationSchemes
• ThereisnoEU-widenotificationscheme.
• Somecountrieshaveimplementedreportingschemesfornanomaterials
usedorplacedonthemarketinthatcountry.
• Eachschemehasdifferenttargetsandrequirements.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
BelgianScheme
• Mandatoryreportingscheme
• Notificationofanynanomaterialmanufacturedonover100gifitisplaced
onthemarketforprofessionaluse.
• Decreetonotifyarticlesandcomplexobjectscontainingananomaterial
whosereleasecannotbeexcludedandispresentat>0.1mass%hasbeen
postponed.
• Proposedinclusionofmixturesinschemehasbeenpostponed.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
FrenchScheme
• Mandatoryreportingscheme
• Manufacturednanomaterialsproduced,importedordistributedinFrance
toprofessionalusersinover100g,wherethenanomaterialisasubstance,
partofamixtureorinanarticlewherereleasewouldbeforeseeableunder
normalconditions.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
DanishScheme
• Mandatoryreportingscheme
• Notificationofmixturesandarticlesthatcontainnanomaterialsintendedfor
saletothegeneralpublic.
• EitherwherethenanomaterialisreleasedundernormaluseORwherethe
nanomaterialisnotreleasedbutitisaCMRorenvironmentallyhazardous.
• Nomassthreshold.
• Manyexemptions.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
NorwegianScheme
• Mandatoryreportingscheme
• Fallswithinthecurrentregisterofallchemicalproducts(substancesand
mixtures)thatareclassifiedashazardouswithrespecttohealth,
environmentorfire/explosivity,ifmorethan100kgaremanufacturedor
imported.
• Nanomaterialsarenowreporteddistinctlytobulkforms.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
SwedishScheme
• SimilarschemetoFrench.
• Duetobeactivein2019.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
ObservatoryforNanomaterials
• TobesetupbyECHAbutwillbeseparatetoECHAwebsite.
• Intendedtoimprovetransparencyaroundnanomaterials.
• Willusenationstateregistriesandothersourcestotrackuseof
nanomaterialsinEU.
• Notintendedtobeobligatoryreportingscheme.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662
Summary
• Therearenonano-specificregulationsintheEU.
• Currentchemicalregulationscanbeappliedtonanomaterials.
• Somemodificationofindividualstudiesmightberequiredwithina
regulation.
• ParticlecharacterisationisnotanobligationunderAnnexVIofREACH,buta
registrantshouldbeabletoprovedatainthedossierisapplicabletotheir
productthroughoutitslifecycle.
• Individualcountriesmayhavereportingprocedures.
NanoMONITOR is partly funded by the European Commission Life+ with
grant agreement LIFE14 ENV/ES/000662