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NanoMONITOR is partly funded by the European Commission Life+ withgrant agreement LIFE14 ENV/ES/000662
Currentlegislativeframeworkfornanomaterials:supporting
REACHregulationNanoMONITOR 2nd Stakeholder’sDay
DrNeilHunt
NanoMONITOR is partly funded by the European Commission Life+ withgrant agreement LIFE14 ENV/ES/000662
• SeniorRegulatoryScientistatTheREACHCentre• WorkedwithinanumberofEUfundedprojectsrelatedtonanomaterials• MARINA,SUN,NanoMONITOR,Gracious
• MemberofthePartnerExpertGroupfortherevisionthenano-specificappendicestotheECHAguidancedocumentsforinformationrequirementsandchemicalsafetyassessment.• TheREACHCentreisoneoftheleadingconsultanciesofferingsupporttoindustrytomeetalltheirglobalregulatoryrequirements.
Introduction
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REACH
Biocides
PlantProtectionProducts
Cosmetics
Foodcontact
Medicinalandveterinaryproducts
• Regulationsarelargelyusebased.• REACHcoversallusesnotcoveredbyotherregulations.• Nonano-specificregulation.• Eachregulationmayrequirenanomaterialstobeassesseddifferentlytobulkforms
RegulatoryframeworkforchemicalsintheEU
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• Thehazardsandrisksarisingfromasubstanceshouldbeknown,andtheappropriateriskmanagementmeasurescommunicated,forsubstancesmanufacturedinorimportedtotheEU.
Toxicological/Ecotoxicological/PhysicalChemicalHazardsidentifiedbyoneentity(LeadRegistrant)
Otherregistrantsshouldreceivepermissiontousethisdataintheirregistrationdossierandensurethatitisrelevanttothesubstancethattheyplaceonthemarket
KeyaspectsofREACH
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• Eachregistrantshouldcharacterisetheirsubstancetoensurethatthehazard/exposure/riskassessmentinthedossierappliestotheirproduct.• Somesubstancesmaybefurtheridentifiedbyotherparameters(Guidanceforidentificationandnamingofsubstances,Section4.2.3)• Particlesizementionedasapossibleparameter.• Whetherornotasubstanceisananomaterialisapossibleparameter.
• Substanceidentificationshouldbesufficienttoassesswhetherthedataintheregistrationdossierisapplicable.
CurrentSubstanceidentificationinREACH
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• AspectsofREACHapplytonanomaterialsastootherformsofasubstance.• Thesameinclusionandexclusioncriteria(polymers,mixtures,exemptions).• Timetableisthesame.• Samebasicinformationrequirementsbasedonproductionvolumesoftheregistrants.• Informationintheregistrationdossiershouldapplytothesubstanceplacedonthemarket.• Testingshouldbeadaptedtothepropertiesofthesubstance.
NanomaterialsandREACH
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• Nanomaterial(draft):• Anatural,incidentalormanufacturedmaterialcontainingparticles,inanunboundstateorasanaggregateorasanagglomerateandwhere,for50%ormoreoftheparticlesinthenumbersizedistribution,oneormoreexternaldimensionsisinthesizerange1nm- 100nm.
• Nanoform(ECHA,RIVM,JRC(2016))• Theterm…….todistinguishformsofasubstancethatfulfiltheECRecommendationonthedefinitionoftheterm‘nanomaterial’butdifferwithregardtosizedistributions,shapeand/orsurfacechemistry.”
Usefuldefinitions
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Primaryparticlesinunboundstate
Primaryparticlesasanagglomerate
Primaryparticlesasanaggregate
• “particles,inanunboundstateorasanaggregateorasanagglomerate”.• Definitionbasedondimensionsofprimaryparticles• Agglomeratecanberelativelyeasilybroken,butaggregatesarenoteasytobreakintotheirconstituentprimaryparticleswithoutdamagingparticles.• Isprimaryparticleoragglomerate/aggregatesizekeyforriskassessment?
Definitionofnanomaterial– Keypoints
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• 50%ormoreoftheparticlesinthenumbersizedistribution• Modalaverageofnumberdistribution• Cananalyticalmethodsmeasurenumberdistribution?• Numberdistributionwilllookdifferenttovolumeorresponsedistributions.• Arealotofpowdersgoingtofallunderthedefinitionunexpectedly?
Definitionofnanomaterial– Keypoints
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• Oneormoreexternaldimensionsisinthesizerange1nm- 100nm.• Particles,rods,needlesandplatescanallbenanomaterials.• Shortestdimensionisthekeyparameter.• Doanalyticalmethodsmeasurethisdimension?• Nanoscaleporesandspacesdonotdefineananomaterial.
Definitionofnanomaterial– Keypoints
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• Itisdifficulttoidentifywhetherasubstanceisananomaterialsornot• Arangeoftestswillberequiredtoreachajustifiedconclusion• Analyticalstrategyandsamplepreparationisvital
Definitionofnanomaterial– Conclusion
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ChemicalSafety
Assessment
Toxicology• Avoidfalsepositives/negatives• Amestest?• Lungburdenoverload?
Physicalandchemical• Watersolubilityvsdispersion• Partitionco-efficientvsagglomerationbehaviour
Environmentalfate• Biodegradation?• Changestosurfacecharacterisatics• Transformationbetweennanoforms
Eco-toxicology• Solutionvssuspension• Insolubilitywaivernotappropriate
REACHhazardendpointmodifications
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• Invitro,insilico,QSARandread-acrosswillbevitaltoavoidlargescaleanimaltesting.
• Propercharacterisationbothbeforeandduringstudiesessential
• Riskassessmentshouldaccountforchangestonanoformthroughthelifecycle.
Intelligenttestingstrategiesfornanomaterials– REACHandbeyond
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ECHAdecision
• Registrantsoftitaniumdioxideshouldincludedetailsofallnanoformsaspartofsubstancecharacterisation.
Industry(Registrants)Appeal
• Thiswouldmeannanoformsofasubstancehadadditionalrequirementstobulkforms.ThisisnotinlinewithAnnexVIofREACH.
BoardofAppeal(BoA)Decision
• BoA foundinfavourofregistrantsBUTitwashighlightedthatitshouldbeshownthatdatainthedossierisapplicabletothesubstanceplacedonthemarket.
RecentBoardofAppealdecision– TitaniumDioxide
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RecentBoardofAppealdecision– SyntheticAmorphousSilica
ECHAdecision
• RegistrationdossiershouldassessdifferentformsofSASincludingsurfacecoatedformsbecausetheymaybelinkedtoadversehealthoutcomes
Industry(Registrants)Appeal
• HowthisadditionalinformationwouldallaytheseconcernshadnotbeenadequatelyprovedforSASandsurfacetreatedSAS
BoardofAppeal(BoA)Decision
• BoA foundinfavourofregistrants.Asimilarappealregardingpyrogenicsilicawasrejected.
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• REACHrevisionscurrentlyestimatedtobeofficiallyinplacein2020.• EuropeanCommissionnon-paperonrevisionsapplicabletonanomaterialsdiscussedinMarch• IntroducesconceptofnanoformstoREACH• ItiscurrentlyexpectedthatparticlecharacterisationtoidentifynanomaterialsanddifferentnanoformswillbemoreprominentinAnnexVI.
RevisionoftheAnnexesofREACH
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• DraftrevisionstoREACHregardingnanomaterialspublishedbytheEuropeanCommission• Availableathttp://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-4925011_en#initiative-details• Thereisanopportunityforanyonetocommentbefore6th November.• NIAisgatheringviewstoputanacross-industrypositiontogether.Lookingforresponsesby26th Octoberandhavingawebinaron30th October
RevisionoftheAnnexesofREACH
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• Theterm‘nanomaterial’isnotpresentintherevision!• Insteadnanoformordifferentnanoformsarediscussed.• Thetermnanoformdoesnotappeartobedefined.• Presumablyasamplethatmeetsthedefinitionofnanomaterialwillberegardedasananoformofasubstance.• Itisnotclearhowaregistrantshoulddecidewhethertheyhaveoneormorethanonenanoformonthemarket.• Willprobablybeuptotheregistranttodecide• MaywellbeextensivelegalargumentsifECHAandtheregistrantdisagree!
KeypointsinproposedrevisiontoREACH– ‘Nanoform’
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• Particlecharacterisationwillbecomecompulsoryfornanoforms.Itwillrequireasaminimum• Particlesizedistribution• Surfacefunctionalisation• Shape/aspectratio/othermorphologicalfeatures• Surfacearea
• Willregistrantsneedtoprovetheydonot havenanoforms?
KeypointsinproposedrevisiontoREACH- Characterisation
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• MostrecommendedadjustmentstostandardtestingprocedurescurrentlyintheappendicestoEndpointSpecificGuidancefornanomaterialswillbecomecompulsory• SubstanceswithnanoformsmaybeonAnnexIII
• Noreducedtestingoptionsforsubstancesregisteredbetween1and10tonnes• Dependsonuseofsubstanceorarticlescontainingthesubstance
• Groupingbetweendifferentnanoformsandbetweenthebulkandnanoformwillneedtobescientificallyjustified• Samechemicalstructurewillnotbeanacceptablejustification
• Willhighertiertestingberequiredforeachnanoformirrespectiveoftheirindividualtonnage?
KeypointsinproposedrevisiontoREACH– Endpointtesting
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• SafetyDataSheets• ObligationforGuidanceonSafeUsetodiscussnanoforms.• GuidanceonSafeUseshouldmatchinformationinSafetyDataSheets• DoesthismeanSafetyDataSheetsmust mentionnanoforms?
• Existingregistrationdossiers• ThereshouldnotbeadditionalrequirementsonnewregistrantsunderREACH• Itisprobablethatexistingregistrationdossierswillneedtobeupdated• Willallregistrantofasolidneedtosubmitupdatedcharacterisationreports?• Extensivetestingondifferentnanoformsforexistingsubstance?
• Brexit!!
KeypointsinproposedrevisiontoREACH– otherimpacts
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• Areviseddefinitionisbeingdiscussed.• Largelythesamebutwithsomeimportantchanges.
• Clarificationthatitdoesnotcoverindividualmolecules(macromolecules,dendrimers).• Notclearwhetherparticleswithadimensionof<1nmwillremainnanomaterialsornot.• SpecificSurfaceAreaof<5m2/cm3maybeusedtodefinesubstancethatarenotnanomaterials.
• The50%bynumbersizedistributionmayberegardedasindicativeandothervaluesmightbemorerelevantincertainsituations.
• Lotsofdebateanddiscussion,sothesemightchange!• HopefullywillbeinplacebeforeanyrevisionofREACHtoavoidreplicationofworkforregistrants.
Reviseddefinitionofnanomaterial
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• BiocidalProductsRegulation• Anactivesubstanceinananoformmustbeauthorisedseparatelytothesamesubstanceinthebulkform.
• CosmeticsRegulation• Nanomaterialsascosmeticingredientsmustbeassessedseparatelytobulkformsofthesamesubstanceiftheyperformcertainrolesinthecosmetic.
• Theingredientslistmustshowthatasubstanceexistsasananomaterial.• FoodContactMaterials
• AnanoformofasubstancecannotberegardedasbeingontheUnionListofauthorisedsubstancesevenifthebulkformisonthelist.
• Assessmentandauthorisationismadeonacasebycasebasis.• Medicaldevices
• Degreeofriskassessmentrequireddependsonlikelihoodofreleaseofnanomaterialsfromthedevice.
NanomaterialsandotherEUregulations
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• ThereisnoEU-widenotificationscheme.• Belgium
• Nanomaterialson>100g• France
• Substance,mixtureandarticlewithpotentialreleaseover100g• Denmark
• MixtureandarticleswherereleaseisexpectedORnanomaterialsisCMR• Nomasslimit
• Norway• Nanomaterialsreportedseparatelyinchemicalproductreportingscheme
• Sweden• SimilartoFrenchreportingscheme,implementedin2019
NationalRegistriesandVoluntaryNotificationSchemes
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• SetupbyECHAbutwillbeseparatetoECHAwebsite(https://euon.echa.europa.eu/)• Intendedtoimprovetransparencyaroundnanomaterials.• WillusenationstateregistriesandothersourcestotrackuseofnanomaterialsinEU.• Notintendedtobeobligatoryreportingscheme.
ObservatoryforNanomaterials
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• USA• ReportingandrecordkeepingrequirementsasstipulatedbyaFinalRuleunderSection8(a)ofTSCA.Effectivefrom14
August2017.• Canada
• Coveredbygeneralchemicalregulations(CEPA).• PublishedaNoticefor“certainnanomaterials”toprovideinformationif>100kgmanufactured.Covers206substances.
• Asia• Nocountryhasnano-specificrequirements• Anumberhavegivenguidanceorareactivelyinvestigatingriskmanagementorareestablishingdatabasesfor
nanomaterials(India,ThePhilippines,SouthKorea,Thailand)• SouthAmerica
• Nonano-specificrequirements• BrazilhaveacooperativeagreementwithNanoREG
• Australia• Coveredbyexistingregulations.• Nano-formsofexistingsubstancedonotneednotification
RestoftheWorld
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• Yes- Forbiocides,cosmetics,foodcontactmaterials• Perhapsnotsomuchatthemoment!– REACH• ThetestingofallsubstancesunderREACHshouldusescientificallyappropriatemethods.• Mostofthetestingmodificationsarerelevanttoinsolublepowdersthatdonotmeetthenanomaterialdefinition• Alljointregistrantsshouldassesswhethertheinformationtheypurchaseisrelevanttotheirproduct• IftherevisionsofREACHcomeintoforce,identifyingnanomaterialswillbecomevital
Isthedefinitionofananomaterialimportant?
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• Therearenonano-specificregulationsintheEU.• Currentchemicalregulationscanbeappliedtonanomaterials.• Somemodificationofindividualstudiesmightberequiredwithinaregulation.• ParticlecharacterisationisnotanobligationunderAnnexVIofREACH,butaregistrantshouldbeabletoprovedatainthedossierisapplicabletotheirproductthroughoutitslifecycle.• ThesemaybecomeobligationsifproposedamendmentstoREACHareenforced.• Individualcountriesmayhavereportingprocedures.
Summary
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Acknowledgements