current legislative framework for nanomaterials ... · nanomaterials •marina, sun, nanomonitor,...

NanoMONITOR is partly funded by the European Commission Life+ withgrant agreement LIFE14 ENV/ES/000662

Currentlegislativeframeworkfornanomaterials:supporting

REACHregulationNanoMONITOR 2nd Stakeholder’sDay

DrNeilHunt


• SeniorRegulatoryScientistatTheREACHCentre• WorkedwithinanumberofEUfundedprojectsrelatedtonanomaterials• MARINA,SUN,NanoMONITOR,Gracious

• MemberofthePartnerExpertGroupfortherevisionthenano-specificappendicestotheECHAguidancedocumentsforinformationrequirementsandchemicalsafetyassessment.• TheREACHCentreisoneoftheleadingconsultanciesofferingsupporttoindustrytomeetalltheirglobalregulatoryrequirements.

Introduction


REACH

Biocides

PlantProtectionProducts

Cosmetics

Foodcontact

Medicinalandveterinaryproducts

• Regulationsarelargelyusebased.• REACHcoversallusesnotcoveredbyotherregulations.• Nonano-specificregulation.• Eachregulationmayrequirenanomaterialstobeassesseddifferentlytobulkforms

RegulatoryframeworkforchemicalsintheEU


• Thehazardsandrisksarisingfromasubstanceshouldbeknown,andtheappropriateriskmanagementmeasurescommunicated,forsubstancesmanufacturedinorimportedtotheEU.

Toxicological/Ecotoxicological/PhysicalChemicalHazardsidentifiedbyoneentity(LeadRegistrant)

Otherregistrantsshouldreceivepermissiontousethisdataintheirregistrationdossierandensurethatitisrelevanttothesubstancethattheyplaceonthemarket

KeyaspectsofREACH


• Eachregistrantshouldcharacterisetheirsubstancetoensurethatthehazard/exposure/riskassessmentinthedossierappliestotheirproduct.• Somesubstancesmaybefurtheridentifiedbyotherparameters(Guidanceforidentificationandnamingofsubstances,Section4.2.3)• Particlesizementionedasapossibleparameter.• Whetherornotasubstanceisananomaterialisapossibleparameter.

• Substanceidentificationshouldbesufficienttoassesswhetherthedataintheregistrationdossierisapplicable.

CurrentSubstanceidentificationinREACH


• AspectsofREACHapplytonanomaterialsastootherformsofasubstance.• Thesameinclusionandexclusioncriteria(polymers,mixtures,exemptions).• Timetableisthesame.• Samebasicinformationrequirementsbasedonproductionvolumesoftheregistrants.• Informationintheregistrationdossiershouldapplytothesubstanceplacedonthemarket.• Testingshouldbeadaptedtothepropertiesofthesubstance.

NanomaterialsandREACH


• Nanomaterial(draft):• Anatural,incidentalormanufacturedmaterialcontainingparticles,inanunboundstateorasanaggregateorasanagglomerateandwhere,for50%ormoreoftheparticlesinthenumbersizedistribution,oneormoreexternaldimensionsisinthesizerange1nm- 100nm.

• Nanoform(ECHA,RIVM,JRC(2016))• Theterm…….todistinguishformsofasubstancethatfulfiltheECRecommendationonthedefinitionoftheterm‘nanomaterial’butdifferwithregardtosizedistributions,shapeand/orsurfacechemistry.”

Usefuldefinitions


Primaryparticlesinunboundstate

Primaryparticlesasanagglomerate

Primaryparticlesasanaggregate

• “particles,inanunboundstateorasanaggregateorasanagglomerate”.• Definitionbasedondimensionsofprimaryparticles• Agglomeratecanberelativelyeasilybroken,butaggregatesarenoteasytobreakintotheirconstituentprimaryparticleswithoutdamagingparticles.• Isprimaryparticleoragglomerate/aggregatesizekeyforriskassessment?

Definitionofnanomaterial– Keypoints


• 50%ormoreoftheparticlesinthenumbersizedistribution• Modalaverageofnumberdistribution• Cananalyticalmethodsmeasurenumberdistribution?• Numberdistributionwilllookdifferenttovolumeorresponsedistributions.• Arealotofpowdersgoingtofallunderthedefinitionunexpectedly?



• Oneormoreexternaldimensionsisinthesizerange1nm- 100nm.• Particles,rods,needlesandplatescanallbenanomaterials.• Shortestdimensionisthekeyparameter.• Doanalyticalmethodsmeasurethisdimension?• Nanoscaleporesandspacesdonotdefineananomaterial.



• Itisdifficulttoidentifywhetherasubstanceisananomaterialsornot• Arangeoftestswillberequiredtoreachajustifiedconclusion• Analyticalstrategyandsamplepreparationisvital

Definitionofnanomaterial– Conclusion


ChemicalSafety

Assessment

Toxicology• Avoidfalsepositives/negatives• Amestest?• Lungburdenoverload?

Physicalandchemical• Watersolubilityvsdispersion• Partitionco-efficientvsagglomerationbehaviour

Environmentalfate• Biodegradation?• Changestosurfacecharacterisatics• Transformationbetweennanoforms

Eco-toxicology• Solutionvssuspension• Insolubilitywaivernotappropriate

REACHhazardendpointmodifications


• Invitro,insilico,QSARandread-acrosswillbevitaltoavoidlargescaleanimaltesting.

• Propercharacterisationbothbeforeandduringstudiesessential

• Riskassessmentshouldaccountforchangestonanoformthroughthelifecycle.

Intelligenttestingstrategiesfornanomaterials– REACHandbeyond


ECHAdecision

• Registrantsoftitaniumdioxideshouldincludedetailsofallnanoformsaspartofsubstancecharacterisation.

Industry(Registrants)Appeal

• Thiswouldmeannanoformsofasubstancehadadditionalrequirementstobulkforms.ThisisnotinlinewithAnnexVIofREACH.

BoardofAppeal(BoA)Decision

• BoA foundinfavourofregistrantsBUTitwashighlightedthatitshouldbeshownthatdatainthedossierisapplicabletothesubstanceplacedonthemarket.

RecentBoardofAppealdecision– TitaniumDioxide


RecentBoardofAppealdecision– SyntheticAmorphousSilica

ECHAdecision

• RegistrationdossiershouldassessdifferentformsofSASincludingsurfacecoatedformsbecausetheymaybelinkedtoadversehealthoutcomes

Industry(Registrants)Appeal

• HowthisadditionalinformationwouldallaytheseconcernshadnotbeenadequatelyprovedforSASandsurfacetreatedSAS

BoardofAppeal(BoA)Decision

• BoA foundinfavourofregistrants.Asimilarappealregardingpyrogenicsilicawasrejected.


• REACHrevisionscurrentlyestimatedtobeofficiallyinplacein2020.• EuropeanCommissionnon-paperonrevisionsapplicabletonanomaterialsdiscussedinMarch• IntroducesconceptofnanoformstoREACH• ItiscurrentlyexpectedthatparticlecharacterisationtoidentifynanomaterialsanddifferentnanoformswillbemoreprominentinAnnexVI.

RevisionoftheAnnexesofREACH


• DraftrevisionstoREACHregardingnanomaterialspublishedbytheEuropeanCommission• Availableathttp://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-4925011_en#initiative-details• Thereisanopportunityforanyonetocommentbefore6th November.• NIAisgatheringviewstoputanacross-industrypositiontogether.Lookingforresponsesby26th Octoberandhavingawebinaron30th October

RevisionoftheAnnexesofREACH


• Theterm‘nanomaterial’isnotpresentintherevision!• Insteadnanoformordifferentnanoformsarediscussed.• Thetermnanoformdoesnotappeartobedefined.• Presumablyasamplethatmeetsthedefinitionofnanomaterialwillberegardedasananoformofasubstance.• Itisnotclearhowaregistrantshoulddecidewhethertheyhaveoneormorethanonenanoformonthemarket.• Willprobablybeuptotheregistranttodecide• MaywellbeextensivelegalargumentsifECHAandtheregistrantdisagree!

KeypointsinproposedrevisiontoREACH– ‘Nanoform’


• Particlecharacterisationwillbecomecompulsoryfornanoforms.Itwillrequireasaminimum• Particlesizedistribution• Surfacefunctionalisation• Shape/aspectratio/othermorphologicalfeatures• Surfacearea

• Willregistrantsneedtoprovetheydonot havenanoforms?

KeypointsinproposedrevisiontoREACH- Characterisation


• MostrecommendedadjustmentstostandardtestingprocedurescurrentlyintheappendicestoEndpointSpecificGuidancefornanomaterialswillbecomecompulsory• SubstanceswithnanoformsmaybeonAnnexIII

• Noreducedtestingoptionsforsubstancesregisteredbetween1and10tonnes• Dependsonuseofsubstanceorarticlescontainingthesubstance

• Groupingbetweendifferentnanoformsandbetweenthebulkandnanoformwillneedtobescientificallyjustified• Samechemicalstructurewillnotbeanacceptablejustification

• Willhighertiertestingberequiredforeachnanoformirrespectiveoftheirindividualtonnage?

KeypointsinproposedrevisiontoREACH– Endpointtesting


• SafetyDataSheets• ObligationforGuidanceonSafeUsetodiscussnanoforms.• GuidanceonSafeUseshouldmatchinformationinSafetyDataSheets• DoesthismeanSafetyDataSheetsmust mentionnanoforms?

• Existingregistrationdossiers• ThereshouldnotbeadditionalrequirementsonnewregistrantsunderREACH• Itisprobablethatexistingregistrationdossierswillneedtobeupdated• Willallregistrantofasolidneedtosubmitupdatedcharacterisationreports?• Extensivetestingondifferentnanoformsforexistingsubstance?

• Brexit!!

KeypointsinproposedrevisiontoREACH– otherimpacts


• Areviseddefinitionisbeingdiscussed.• Largelythesamebutwithsomeimportantchanges.

• Clarificationthatitdoesnotcoverindividualmolecules(macromolecules,dendrimers).• Notclearwhetherparticleswithadimensionof<1nmwillremainnanomaterialsornot.• SpecificSurfaceAreaof<5m2/cm3maybeusedtodefinesubstancethatarenotnanomaterials.

• The50%bynumbersizedistributionmayberegardedasindicativeandothervaluesmightbemorerelevantincertainsituations.

• Lotsofdebateanddiscussion,sothesemightchange!• HopefullywillbeinplacebeforeanyrevisionofREACHtoavoidreplicationofworkforregistrants.

Reviseddefinitionofnanomaterial


• BiocidalProductsRegulation• Anactivesubstanceinananoformmustbeauthorisedseparatelytothesamesubstanceinthebulkform.

• CosmeticsRegulation• Nanomaterialsascosmeticingredientsmustbeassessedseparatelytobulkformsofthesamesubstanceiftheyperformcertainrolesinthecosmetic.

• Theingredientslistmustshowthatasubstanceexistsasananomaterial.• FoodContactMaterials

• AnanoformofasubstancecannotberegardedasbeingontheUnionListofauthorisedsubstancesevenifthebulkformisonthelist.

• Assessmentandauthorisationismadeonacasebycasebasis.• Medicaldevices

• Degreeofriskassessmentrequireddependsonlikelihoodofreleaseofnanomaterialsfromthedevice.

NanomaterialsandotherEUregulations


• ThereisnoEU-widenotificationscheme.• Belgium

• Nanomaterialson>100g• France

• Substance,mixtureandarticlewithpotentialreleaseover100g• Denmark

• MixtureandarticleswherereleaseisexpectedORnanomaterialsisCMR• Nomasslimit

• Norway• Nanomaterialsreportedseparatelyinchemicalproductreportingscheme

• Sweden• SimilartoFrenchreportingscheme,implementedin2019

NationalRegistriesandVoluntaryNotificationSchemes


• SetupbyECHAbutwillbeseparatetoECHAwebsite(https://euon.echa.europa.eu/)• Intendedtoimprovetransparencyaroundnanomaterials.• WillusenationstateregistriesandothersourcestotrackuseofnanomaterialsinEU.• Notintendedtobeobligatoryreportingscheme.

ObservatoryforNanomaterials


• 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


• Yes- Forbiocides,cosmetics,foodcontactmaterials• Perhapsnotsomuchatthemoment!– REACH• ThetestingofallsubstancesunderREACHshouldusescientificallyappropriatemethods.• Mostofthetestingmodificationsarerelevanttoinsolublepowdersthatdonotmeetthenanomaterialdefinition• Alljointregistrantsshouldassesswhethertheinformationtheypurchaseisrelevanttotheirproduct• IftherevisionsofREACHcomeintoforce,identifyingnanomaterialswillbecomevital

Isthedefinitionofananomaterialimportant?


• Therearenonano-specificregulationsintheEU.• Currentchemicalregulationscanbeappliedtonanomaterials.• Somemodificationofindividualstudiesmightberequiredwithinaregulation.• ParticlecharacterisationisnotanobligationunderAnnexVIofREACH,butaregistrantshouldbeabletoprovedatainthedossierisapplicabletotheirproductthroughoutitslifecycle.• ThesemaybecomeobligationsifproposedamendmentstoREACHareenforced.• Individualcountriesmayhavereportingprocedures.

Summary


Acknowledgements

current legislative framework for nanomaterials ... · nanomaterials •marina, sun, nanomonitor,...

Documents