How REACH Is Failing to Regulate Nanomaterials and How it Can Be Fixed
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Just Out
of REACH How REACH Is Failing toRegulate Nanomaterials
and How it Can Be Fixed
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Just
Out
of
Reach
6February2012
DavidAzoulay,
ManagingAttorney,GenevaOffice,Switzerland
TheCenterforInternationalEnvironmentalLaw(CIEL)
+41223214774
www.ciel.org
AboutCIEL
Foundedin
1989,
the
Center
for
International
Environmental
Law
(CIEL),
uses
interna
tionallawandinstitutionstoprotecttheenvironment,promotehumanhealth,anden
sureajustandsustainablesociety.WithofficesinWashington,DCandGeneva,CIELs
staffofinternationalattorneysworkintheareasofhumanrightsandtheenvironment,
climatechange,lawandcommunities,chemicals,tradeandtheenvironment,interna
tionalenvironmentalgovernance,biodiversityandinternationalfinancialinstitutionsby
providinglegalcounselandadvocacy,policyresearchandcapacitybuilding.
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TableofContents
Executive
Summary
_________________________________________________________
1
List
of
acronyms
and
abreviation ___________________________________________________ 6
Section1/Introduction______________________________________________________7
Section2/Keyregistrationprovisionsrelevanttonanomaterials ____________________9
Section3/ApplyingREACHprovisionstonanomaterials___________________________12
3.1Identifyingnanomaterials_____________________________________________________ 12
3.2Thephaseinstatusanditsconsequencesontheregistrationdeadlineofnanomaterials 14
3.3Tonnagethresholds__________________________________________________________ 16
3.4Adequacyofriskassessmentprovisions_________________________________________ 18
3.5Summary:FourgapsregardingnanowithinREACH________________________________ 21
Section4/Addressingthenanogaps:thelimitsofsubstanceidentification___________23
4.1NanomaterialsasWellDefinedSubstances ____________________________________ 23
4.1.1Nanomaterialsderivedfromabulkchemical___________________________________________22
4.1.2Nanomaterialswithnocorrespondingbulksubstance___________________________________26
4.2NanomaterialsasSubstancesofDefinedChemicalCompositionandAdditionalIdentifiers27
Section5/Policyrecommendations___________________________________________29
Section6/Conclusion______________________________________________________33
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ExecutiveSummary
MorethanthreeyearsaftertheEuropeanCommissionscommunicationontheregula
toryaspectsofnanomaterials,numerousquestionsremainregardingthepracticaleffectiveness
ofexistingEuropeanUnionlawtomanagenanomaterials.REACH,theprimaryEUregulationon
chemicals, isassumed tobe the regulatorycornerstone foraddressing thehealth,safetyand
environmentalrisksofnanomaterials.Inparticular,REACHregistrationisdescribedastheideal
tooltofilltheproblematicknowledgegaponnanomaterials.However,thelimitedinformation
gathered in the first registrationphasedemonstrates thatREACH isnot livingup toexpecta
tionsfornanomaterials.
Thestudy identifiesfourareas inwhichREACHsregistrationprovisionsfailtoaccount
forthespecificitiesofnanomaterials:
1.Identifyingnanomaterials:REACHcurrentlydoesnotdefinenanomaterialsandleavestothe
registrantthefinaldecisionofdeterminingwhetherasubstanceisananomaterial.Asaresult,
thefinaldecisionto identifysubstancesasnanomaterialsismadebytheregistrantsaccording
to theirown criteria. Inaddition to creatingconfusion in the implementationofREACH, this
situationislikelytoseverelyimpaireffortstouseREACHasthemainregulatorytoolforgather
ing informationonnanomaterialson themarketanddefiningand implementingappropriate
riskmanagementmeasuresifneeded.
The limited information gathered in the first
registrationphasedemonstrates thatREACH is
notlivinguptoexpectationsfornanomaterials.
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2.Phaseinstatusofnanomaterials:REACHdistinguishesnewandexistingsubstances,between
substancesthatwerealreadyonthemarketbeforeitsentryintoforce(socalledphaseinsub
stances)andnewsubstances(socallednonphaseinsubstances).AsREACHiscurrentlyimple
mented, ifamaterial isconsideredaphaseinsubstance in itsbulkform,thenananomaterial
sharingthesamechemicalcompositionwillautomaticallybenefitfromthebulkversionsphase
in status, regardless of its newness. As a consequence, nanomaterials derived from a bulk
phasein substance,or sharing the samechemicalcomposition,willnotbe registeredbefore
the2013deadline if theyaremanufacturedor imported inquantitiesabove100 tonnesper
yearperregistrant. Suchmaterialsmanufacturedorimportedinquantitiesof1100tonnesper
yearperregistrantwillnotberegistereduntil2018,furtherextendingtheknowledgegapsur
roundingnanomaterials.Becausemostnanomaterialscurrentlyonthemarketarederivedfrom
parentsubstancesthatbenefitfroma phaseinstatus,thevastmajorityofnanomaterialscur
rentlymarketedbenefitfromdelayedregistrationdeadlinesindirectcontradictionwiththeno
data,nomarketprincipleunderlyingREACH.
3.Tonnagethresholdsandnanomaterials:Productionvolumesplayasignificantrole indeter
miningwhetherandhowsubstancesareaccountedforunderREACH.Theoverallruleofthumb
is that the higher the volume, themore data is required, and the sooner the registration.
REACHregistrationrequirementsapplyonlyforproductionvolumesofonetonneormoreper
yearpermanufacturerorimporter.Thisvolumethresholdisgrosslyinadequatefornanomate
rials,usuallyproducedinmuchsmallerquantities.Furthermore,inthefewcasesinwhichnano
materialsareproducedinvolumesabovetheonetonne/yearperregistrantthreshold,mostof
thosenanomaterialswillbenefitfromaphaseinstatus. Asaresult,the informationrequired
bytheregistrationdossierwillbe limitedtothephysicochemicalpropertiesofthesubstance,
excluding any toxicological and ecotoxicological information, which may otherwise be re
quired. Nordoesthedossierincludeexposureinformation,whichiscurrentlyrequiredonlyfor
substances of very high concern. Similar concerns apply to the availability of information
downthesupplychain.
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4.Riskassessmentprovisions:According to theScientificCommitteeonEmergingandNewly
Identified Health Risks (SCENIHR) and independent researchers, and notwithstanding other
limitationsdiscussedabove,anyriskassessmentinformationmadeavailableonananomaterial
inthecontextofREACHwouldbebasedontestingguidelinesthatfailtoconsiderthespecial
hazardsandexposurepathwaysofnanomaterials.Furthermore, ifabulksubstance ischarac
terizedasnonhazardous,as isthecaseforthevastmajorityofsubstancesfromwhichnano
materialsarederived, thisclassificationwillbeextended to thenanoformof thesubstance,
withnoadditionalrequirementstogeneratedataonspecificnanoformeffects. Therefore,a
nanomaterialcouldmovethroughitsentirelifecyclewithoutfurtherrequirementstoassessits
properties.Giventhese limitations,REACH in itscurrentformdoesnotequipdecisionmakers
tomanagetherisksofnanomaterials.
SeveralREACHImplementationProjectsonNanomaterials(RIPoN1,2and3)werede
signedtoaddresstheseconcernswithoutmodifyingthetextoftheregulation.RIPoN1,inpar
ticular,aimedatadapting the substance identification rules (defined inaTechnicalGuidance
Document(TGD))toclarifythe implementationofREACHtonanomaterials.Thisexpertgroup
proposed two options: addressing nanomaterials as 1) well defined substances or as 2)
Substancesofdefinedchemicalcompositionandadditionalidentifiers.
Althoughtheseoptionsmightimprovethesituationtoalimitedextent,mostoftheis
sues identifiedabovewould remain. Inparticular, theproblems related to the tonnageband
rulesandtheinadequacyofthetraditionalhazardandexposuretestingguidelinespersist.Fur
thermore,substance identificationrulesarenotbinding,soattempts toaddress thegaps for
nanomaterialsbymodifyingtheserulescouldcreateconfusion in implementationandthwart
effortstouseREACHasthemainregulatorytoolfornanomaterials.IfREACHistoserveasthe
regulatorycornerstonefornanomaterials,itwillrequiremoreprofoundchangesoftheregula
toryframework.
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ThisstudypresentstwooptionsforalteringREACHtoaccommodatenanomaterials:
Option1:ModifyingtheREACHtext,itsannexesandtechnicalguidancedocuments
Addressing the regulatory gaps for nanomaterials identified in the registration process of
REACHwouldrequire,ataminimum:
Includingadefinitionofnanomaterial in theREACH text,presumably inArticle3,
nexttothegeneralsubstancedefinition;
Specifying thatnanomaterialsarenotconsideredphasein substances inArticle3
(20);
Introducingspecific(andsignificantlylower)tonnagetriggersforsubstanceswithin
the scopeof thedefinitionof nanomaterialasArticle7(4)bis.Thismodification
wouldrequireacorrespondingmodificationofArticle6;
ModifyingArticle14(1)torequirethatregistrationdossiersfornanomaterialscate
goricallyincludeaChemicalSafetyAssessment,inordertoreachthehighlevelof
protectionofhumanhealthandtheenvironment;and
Finally,updating testing and risk assessmentprovisions andguidelines to include
specificnanomaterialsprovisions,throughmodificationsofAnnexesVItoXaswell
astechnicalguidancedocuments.
These proposalswould go a longway to ensure that the registration process under
REACH generatesnecessary informationonnanomaterials.Additionalmodificationsofother
REACHprovisions,annexes,andguidancewouldberequiredtoaddressshortcomingsofother
coreelementsofREACH,includingevaluation,authorisation,andrestriction.
InsteadofmodifyingREACHitself,apossiblealternative
for addressing nanomaterials would be to develop a
standaloneregulationspecifyinghowREACHtoolsand
provisionsaretobeappliedtonanomaterials.
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Option2:Developingastandaloneregulation
InsteadofmodifyingREACHitself,apossiblealternativeforaddressingnanomaterialswouldbe
todevelopastandaloneregulationspecifyinghowREACHtoolsandprovisionsaretobeap
pliedtonanomaterials.Thisregulationcouldlistgeneralprinciplesforthemanagementof
nanomaterials,indicatethatalltermswouldbeconsistentwiththeirdefinitioninREACHand
definenanomaterialsusingtheCommissionproposal.Otherprovisionswould,amongother
things,establishaproduction/importthresholdof10kilogramsforregistration,togetherwith
registrationdeadlines.Thisstandalongregulationcouldserveasananopatch,providinga
simplerandmoreelegantsolutiontoadaptingREACHtothespecialpropertiesofnanomateri
als.Bycreatingaflexibleinstrumentwithsimplifiedrevisionprocedures,itwouldbepossibleto
adapttochangingexperiencewithnanomaterials,withoutaddingfurtherlayersofcomplexity
toREACH.
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AcronymsandAbbreviations
CA CompetentAuthority
CAS ChemicalAbstractsService
CLP Classification,Labeling,andPackagingRegulation
CSA ChemicalSafetyAssessment
DG DirectorateGeneral
ECHA EuropeanChemicalsAgency
EEB EuropeanEnvironmentalBureau
EINECS EuropeanInventoryofExistingCommercialChemicalSubstances
ERS ExistingSubstancesRegulation
EU EuropeanUnion
IUPAC InternationalUnionofPureandAppliedChemistry
JRC JointResearchCentre(EuropeanCommission)
NONS NotificationofNewSubstancesRegulation
PBT Persistent,Bioaccumulative,andToxicsubstance
RCEP UKRoyalCommissiononEnvironmentalPollution
REACH Registration,Evaluation,Authorization,andRestrictionofChemicals
RIPoN REACHImplementationProjectsonNanomaterials
RIVM DutchNationalInstituteforPublicHealthand
theEnvironment
SCENIHR ScientificCommitteeonEmergingandNewlyIdentifiedHealthRisks
SRU SachverstndigenratfrUmweltfragen
(GermanAdvisoryCouncilontheEnvironment)
TGD TechnicalGuidanceDocument
vPvB veryPersistentandveryBioaccumulative
substances
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SECTION
1/
Introduction
MorethanthreeyearsaftertheEuropeanCommissionscommunication1
ontheregula
tory aspects of nanomaterials, questions relating to the regulatory provisions applicable to
nanomaterialsintheEuropeanUnionarestillnumerous.Fromimprovedproductsandservices,
tobettertargetedmedicinesandenhancedphysicalcharacteristicsofnaturalresources,nano
materialsareanticipatedtopavethewaytowardsnewinteractions,reshapingandshiftingso
cietaldynamics.2Therapidgrowthofnanoapplications,however,coupledwiththepotentialof
nanomaterialstoadverselyimpacthumanhealthandtheenvironment,hasplacedtheissueof
safetyattheforefrontofcurrentregulatoryconcerns.3
[C]hemicalsregulation,andinparticularREACH,4constitutesacornerstoneforaddress
inghealth,safetyandenvironmentalrisksinrelationwithnanomaterials...5However,many
interestedpartiesincludingmemberStates,6theEuropeanParliament,
7consumersorganiza
1EuropeanCommission,Communicationfrom
the
Commission
to
the
European
Parliament,
the
Council
and
the
EuropeanEconomicandSocialCouncilCommitteeontheRegulatoryAspectsofNanomaterials.Sec(2008)2036,
17June2008,availableathttp://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf(hereinafter
CommissionNanomaterialsRegulationReview2008).2EuropeanEnvironmentalBureau,EEBpositionpaperonnanotechnologiesandnanomaterials,Smallscale,big
promises,divisivemessages,February2009,at1.3ScientificCommitteeforEmergingandNewlyIdentifiedHealthRisks,Opinionontheappropriatenessoftherisk
assessmentmethodologyinaccordancewiththeTechnicalGuidanceDocumentsfornewandexistingsubstances
forassessingtherisksofnanomaterials,Brussels:EuropeanCommissionHealth&ConsumerProtectionDirector
ateGeneral,28(June2007),availableathttp://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/
scenihr_o_010.pdf(hereinafterSCENIHR2007)4
RegulationoftheEuropeanParliament&CouncilNo.1907/2006,Registration,Evaluation,AuthorisationandRestrictionofChemicalsRegulation,2007O.J.(L136)3,18(hereinafter"REACH").5CommissionstaffworkingdocumentaccompanyingdocumenttotheCommunicationfromtheCommissionto
theEuropeanParliament,theCouncilandtheEuropeanEconomicandsocialCouncilCommitteeontheregula
toryaspectsofnanomaterials. Com(2008)366final,17June2008,availableathttp://ec.europa.eu/
nanotechnology/pdf/com_regulatory_aspect_nanomaterials_2008_en.pdf.6Seee.g.,theNLCAreactionondocumentCaracal/58/2011,Brussels,20July2011onRipoN1;theFRCAcom
mentsondocumentCaracal/58/2011andquestionfromtheCommissiononthewayforwardconcerningtheJRC
finalreportonRIPoN1,1September2011;7EuropeanParliament,Resolutionof24April2009onRegulatoryAspectsofNanomaterials,(2008/2208(INI)),
P6_TA(2009)0328(hereinafterEUParliament2009Resolution).
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tions,8tradeunions
9andenvironmentalorganizations
10haveunderscoredtheneedtoadapt
REACHprovisionsand implementationprocesses toensure thatnanomaterialsaresubject to
thesame informationrequirementsandprotectionsasotherchemicals.Theobjectiveof this
studyistoexploreindetailhownanomaterialsaretreatedundertheRegistrationprovisionsof
REACHthatsupporttheprincipleofnodata,nomarket,andsuggestchangeswhereneeded.
RegistrationiscriticaltothefunctioningofREACHbecauseitgeneratesthefundamentalinfor
mationonwhich the safetyofchemicals isjudged. IfnanomaterialsevadeRegistration,or if
theiradverseeffectsareunderestimated,theremainingprovisionsofREACH,includingEvalua
tion,AuthorisationandRestrictions,couldbeundermined.Hownanomaterialsaretreatedun
dertheseotherprovisionsisbeyondthescopeofthisanalysis.
REACHisbasedontheprimaryunderstandingthatadequateinformationregardingeach
substance provides the basis for identifying and implementing riskmanagementmeasures
whenneeded.
8SeeTheEuropeanConsumersOrganization(BEUC),TheEuropeanAssociationfortheCoordinationofCon
sumerRepresentation inStandardization(ANEC),Nanotechnology:Smallisbeautifulbutisitsafe?,ANEC&BEUC
leafletonnanotechnology andnanomaterials,November2009,availableathttp://docshare.beuc.org/docs/1/
NKOLJLCBMGLDJPKAOEPCGOOGPDBG9DBW769DW3571KM/BEUC/docs/DLS/2009 0089301E.pdf,at6.9SeetheEuropeanTradeUnionConfederation(ETUC),ETUC2
ndResolutiononnanotechnologies andnanomateri
als,AdoptedattheExecutiveCommitteeon12December2010,availableathttp://www.etuc.org/IMG/pdf/13
GB_final_nanotechnologies_and_nanomaterial.pdf,at4,5.10SeetheEuropeanEnvironmentalBureau,EEBpositionpaperonnanotechnologiesandnanomaterials,small
scale,bigpromises,divisivemessages,February2009,availableathttp://www.eeb.org/EEB/?
LinkServID=5403FF15998845A30E327CBA2AFD88BA,at7,910.
Ifnanomaterials
evade
Registration,
or
if
theiradverseeffectsareunderestimated,the
remaining provisions of REACH, including
Evaluation, Authorisation and Restrictions,
couldbeundermined.
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The absence of adequate, comprehensive information for nanomaterials is amajor
problemfacedbyregulators in identifyingand implementingregulatoryprovisionsrelevantto
nanomaterials,and tomakeuseof the full scopeofREACHmechanisms.Registrationunder
REACH11isdesignedtoremedyexactlythiskindofknowledgegap,requiringthesubmissionof
essentialdataonallsubstancesmarketed intheEUtoenabletheapplicationofthemostap
propriate regulatory provisions. The successful implementation of REACH registration provi
sionstonanomaterialsisthereforecritical.
However,experiencefromthefirstregistrationroundstronglysuggeststhatregistration
ofnanomaterialshasbeenverylimitedandhasnotyethelpedsignificantlyinbridgingtheexist
ingknowledgegap.
This studywill therefore focus on the adaptations to REACH needed to ensure that
nanomaterialsareproperlyregisteredandthattheregistrationphaseprovidestheinformation
necessarytofurtherimplementtheriskmanagementtoolsintegratedintheREACHframework.
AfterabriefsummaryofREACHprovisions relevant to the registrationofnanomaterials, the
studywill identifyobstaclesand legalshortcomingsthat impedethesuccessfulregistrationof
nanomaterials, review thepossible roleof substance identification rules in addressing these
shortcomingsandproposepolicyoptionstoremedytheremaininggaps.
SECTION
2
/
Key
registration
provisions
for
nanomaterials
TheregistrationprovisionsofREACHarefoundedonthenodata,nomarketprinciple.
Theseprovisionsrequiremanufacturersandimporterstosubmitaminimumsetofinformation
onasubstanceinordertomarketthatsubstancewithintheEU.12Thisgeneralobligationtoreg
isternanomaterialsappliessolelyforthosemanufacturedorimportedinquantitiesof1tonne
11REACH,TitleII,Arts5 24.
12REACH,Art5,Art6.
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ormoreperyear.13Theregistrationdossiermust
besubmittedtotheEuropeanChemicalsAgency
(ECHA)forsubstancesmanufacturedorimported
in the EU above the 1 tonne threshold (or, for
substances in articles, that are intended for re
leaseduringnormalusageof thearticle),unless
statedotherwise.14
Under this regulation, registrants are responsible for complyingwithdataproduction
andtestingrequirementsunder theRegulation.Theregistrationdeadlineand informationre
quirementsvarydependingonthehazardprofileandthequantitymanufacturedorimported.
Fourtonnagebandsactasregulatorythresholds(1 10tonnes,10100tonnes,1001,000ton
nes, and1,000+ tonnes). Information requirementsbecomeprogressivelymoreextensive as
the tonnageband increases. The rationale behind this approachwas the assumption that a
higher tonnagemeansahigherexposure,which implieshigher risksposedby thesubstance.
Theemergenceofnanomaterialsmightchallengethisassumption.
Furthermore,REACHdistinguishes the tensof thousandsof chemicals alreadyon the
marketfromnewchemicalsseekingpremarketapproval.Registrationoftheexistingchemical
inventory isstaggered inthreephases,withspecificdeadlines in2010,2013,and2018.These
phaseinsubstances includechemicals listed intheEuropean InventoryofExistingCommer
cialChemicalSubstances(EINECS)priortotheentryintoforceofREACH.Irrespectiveoftheir
productionvolume,phaseinsubstancesbenefitfromdelayedregistrationdeadlinesprovided
that theywere successfully preregistered byDecember 1, 2008.15 Preregistration required
manufacturersand importersofchemicalsdeterminedtoqualifyforphaseinstatustosub
13REACH,Art6,withtheexceptionofSubstancesofVeryHighConcern.
14REACH,Art7.AlthoughforsubstancesinarticlesmeetingthecriteriainArt57andidentifiedinaccordancewith
Art59(1),aproducerorimportermustnotifytheAgencyinaccordancewithArt7(4)ifthesubstanceispresent
ingthosearticlesinquantitiestotalingover1tonneperproducer/importerperyear,andthesubstanceispresent
in,thosearticlesaboveaconcentrationof0,1%w/w.15REACH,Art3(20).
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mitinformationontheidentityofthesubstancetoECHA,includingitsEINECSnumber(ifrele
vant),tonnageband,andanyapplicableidentifiersuchasCASnumberorIUPACname.16
Full registration requirements foundunderArt10ofREACH include thenecessity for
manufacturersand importerstosubmitatechnicaldossier.Theserequirementsaremeantto
gatheraminimumsetofinformationoneachsubstance.17Forsubstancesinthe10tonneston
nage band and higher, registration further requires a detailed chemical safety assessment
(CSA),18basedonmorecomprehensiveanddetaileddataonthe intrinsicproperties,usesand
exposuresofeachsubstance.19Significantly, theCSArequires theassessmentofbasichazard
characteristics (e.g.,physicochemical,environmental,persistence,bioaccumulation,andtoxic
ity),and,ifindicated,anexposureassessmentandriskcharacterization.20
16AnEINECSnumberwasassignedtoeachchemicalsubstanceundertheEuropeanInventoryofExistingCommer
cialSubstances,whichwassubsumedbyREACH.SubstanceswithEINECSnumberswereavailableintheEUbe
tweenJanuary1,1971andSeptember18,1981.EuroChem,RegistryNumbersDescription,http://
www.eurochem.cz/index.php?MN=Registry+Numbers&ProdID=00026D060C0537860002ED39(lastvisitedAug.
4,2010).CAS(ChemicalAbstractServices)numbers,ontheotherhand,areuniquenumericalidentifierswithout
scientificsignificance.CASisadivisionoftheAmericanChemicalSociety.CAS,CASRegistry&CASRegistryNum
bers,http://www.cas.org/expertise/cascontent/registry/regsys.html (lastvisitedAug.4,2010).17REACH,Art14(1);Art10respectively.
18REACHArt.10,14;Withtheexceptionofsubstancesinarticlesthatarepresentinlowconcentrations.
19R.G.Lee&S.Vaughan,REACHingDown:NanomaterialsandChemicalSafetyintheEuropeanUnion(Regulatory
GovernanceStandingGroup,RegulationintheAgeofCrisis,ConferencePaper,2010),availableathttp://
regulation.upf.edu/dublin10papers/5B3.pdf,at18.20REACHArt.14(3)&(4);Thelasttwostepsarenecessarywhereasubstanceisclassifiedasdangerousorfound
tobeeitheraPBTorvPvBsubstance,asperE.SpencerWilliamsetal.,TheEuropeanUnion'sREACHRegulation:A
Reviewof
Its
History
and
Requirements,30CriticalRev.inToxicology553,556(2009),at561.
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SECTION
3
/
Applying
REACH
provisions
to
nanomaterials
REACHcontainsstrongprovisionstograduallycollectminimumdataforallsubstancesavail
ableintheEUmarketinquantitiesofmorethanonetonne.REACHprovisionsarefurthercom
plimentedbyextensiveTechnicalGuidanceDocuments(TGDs)thatspecifyhowto implement
the various provisions. However, because both REACH and the TGD were drafted before
nanotechnologywaswidelyused,neithertheregulationnortheguidancearefullyadaptedto
answerthequestionsraisedbythespecialpropertiesofnanomaterials.Thereare fourmajor
gapsfornanomaterialsunderRegistration:(1)theidentificationofnanomaterials;(2)phasein
status;(3),tonnagethresholds;and(4)riskassessmentmethods.
3.1Identifyingnanomaterials
Thereisageneralconsensusthatnanomaterialsarenotexcludedbythesubstancedefini
tioninREACH.ButREACHprovidesonlylimitedopportunitiestoidentifythemassuch21andto
take intoaccounttheirspecialcharacteristics. The limitations in identifyingnanomaterialsare
particularlyseverewhenabulksubstancewithasimilarchemicalcompositionexists.
Althoughtheymaybevariantsofbulksubstances,sharingthemolecularstructureorthe
same chemical composition, nanomaterials possess unique properties, which are exhibited
solelyatthenanoscale.22Typicalbulksubstanceparameterslikeaqueoussolubility,rateofdis
21REACH,Art.3(1).
22EuropeanCommission,EnvironmentDirectorateGeneral&Enterprise&IndustryDirectorateGeneral,Follow
uptothe6thMeetingoftheREACHCompetentAuthoritiesfortheImplementationofRegulation(EC)1907/2006
(REACH),CA/59/2008rev.1(Dec.16,2008),availableathttp://ec.europa.eu/enterprise/sectors/chemicals/files/
reach/nanomaterials_en.pdf,(hereinafter CommissionFollowuptothe6thREACHCAMeeting),at4; Swedish
expert,intheJRCEuropeanCommission,InstituteforHealthandConsumerProtection,AdvisoryReport,REACH
ImplementationProjectSubstanceIdentificationofNanomaterials(RIPoN1),AAN070307/2009/D1/534733
betweenDGEnvironmentandJRC,March2011.(hereinafterAdvisoryReportfortheRIPoN1process),avail
ableathttp://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon1.pdf,Appendix1,at1.
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solution,dynamicsofdispersion,meltingpoint,conductivity,physicaladsorption,ormagnetic
qualitiescangreatlydifferfornanomaterials.23
ThesecondREACHImplementationProjectonNanomaterials(RIPoN2),focusedon infor
mationrequired forcharacterisingandevaluatingnanomaterials,proposedasetofmodifica
tionsofaTGDthatwasconsideredpoorlysuitedtonanomaterials(i.e.,withregardstoprepa
ration, exposure quantifications,measurement, dosemetrics, etc.). Recommendations from
RIPoN2 address a number of domains (including physiochemical properties, toxicological,
ecotoxicologialendpoints, andmore),whichwould require amodificationof theREACH an
nexes.However,forsuchmodifications,onceadopted,tobeimplemented,nanomaterialsmust
firstbesystematicallyidentified.ThefifthversionoftheInternationalUniformChemicalInfor
mationDatabase (IUCLID5)systemallows registrants to identifynanomaterials in registration
dossiers.REACH,however,doesnotexplicitlydefinenanomaterials.Therefore, the finaldeci
sionindeterminingwhetherasubstanceisananomaterialrestswiththeregistrant.24
Asaresult,itisthediscretionofregistrantstoidentifysubstancesasnanomaterialsaccord
ingtotheirowncriteria.InadditiontocreatingconfusionintheimplementationofREACH,this
situationislikelytothwarteffortstouseREACHasthemainregulatorytooltogatherinforma
tiononnanomaterialson themarketand todefineand implementappropriate riskmanage
mentmeasuresifneeded.
23ScientificCommitteeforEmergingandNewlyIdentifiedHealthRisks,Opinionontheappropriatenessoftherisk
assessmentmethodologyinaccordancewiththeTechnicalGuidanceDocumentsfornewandexistingsubstances
forassessingtherisksofnanomaterials,Brussels:EuropeanCommissionHealth&ConsumerProtectionDirector
ateGeneral,28(June2007),availableathttp://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/
scenihr_o_010.pdf(hereinafterSCENIHR2007),at13,28.24SeeREACH,AnnexVI,Step2,statingTheregistrantshallidentifywhatinformationisrequiredfortheregistra
tion
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3.2Thephaseinstatusofnanomaterials
Under REACH, substances are currently identified by their chemical composition alone.
When two substances share the same chemical composition, they are considered tobe the
samesubstance.Asaconsequence,ifasubstanceexistsbothinthebulkandnanoform,andif
thebulksubstanceisaphaseinsubstance,ananomaterialsharingthesamechemicalcomposi
tionwillautomaticallybenefit from thebulkversionsphasein status, regardlessof itsnew
ness.25 This canbe inferred from the EINECS reporting rules and theManualofDecisions,
26
whichstates that,[S]ubstances innanoformwhichareEINECSshallbe regardedasexisting
substances.27TheCommissionEACHReview further stresses thispointby stating thateven
though potential registrantsmay decide that the bulk and nanoform should be registered
separatelyduring theSIEF formationprocessdue tosuch intrinsicdifferences, thenanoform
wouldstillbeallowedretainphaseinstatus.28
Thisfailuretoincludeadditionalidentifiers,such
asthematerialssize,representsoneofthefundamentalgapsinREACHsabilitytoeffectively
regulatenanomaterials.
Asaconsequence,nanomaterialssharingthesamechemicalcompositionwithabulkphase
insubstancewillnotberegisteredbeforethe2013deadline iftheyaremanufacturedor im
portedinquantitiesabove100tonnesperyearperregistrant. Nanomaterialsmanufacturedor
imported in quantities of 1100 tonnes per year per registrantwill not be registered until
2018,29withtheconsequencethatthecurrent,longstandingknowledgegaponnanomaterials
willbeprolongedstillfurther.
25Commission,Followuptothe6
thREACHCAMeeting,supranote22,at78,10.
26ManualofDecisionsforImplementationoftheSixthandSeventhAmendmentstoDirective67/548/EECon
DangerousSubstances,Directives79/831/EECand92/32/EECNonconfidential version,availableathttp://
ecb.jrc.ec.europa.eu/esis/doc/Manual_of_decisions.pdf,(hereinafterMOD).27MOD,supranote26,Section5.1.3,at64,asperTheAdvisoryReportfortheRipoN1process,supranote22,at
20.28Commission2008REACHReview,supranote1,at10(statingthatwheretwosubstancesformerlyfellunderthe
sameEINECSnumber,butwereconsideredtoodissimilartoregistertogether,bothsubstanceswouldneverthe
lessretainphaseinstatusunderREACH).29REACHArts23(2),(3).
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Therationaleforgrantingadelayedregistrationdeadlineforphaseinsubstancesliesinthe
practicalchallengesofregisteringandevaluatingthetensofthousandsofsubstancesalready
present intheEUmarketbeforetheadoptionofREACH.Basedontheassumptionthatbasic
informationon such substancesalreadyexists,phasein substancesarenotprioritizedunder
REACHunlesswarrantedbyspecifichazardouscharacteristics (seeArticle57). However, this
reasoningmaynotbe relevant tonanomaterialsas,even though theirchemicalcomposition
wasnotunknownatthetimeofadoption,theirphysiochemical,toxicologicalandecotoxicologi
calproperties,aswellasusesandexposurepatternsmaydiffergreatlyfromtheirbulkcounter
parts.Toxicologicalandecotoxicologicalinformationonbulksubstancesarethereforenotauto
matically transposable to the corresponding nanomaterials. A simple read across from the
bulkform,asproposedbytheEuropeanchemical industryfederation isnotalwayspossible.30
Asaresult, theavailabilityof toxicologicalandecotoxicological informationon thebulk form
doesnotjustifythephaseinstatusgrantedtonanomaterials.
Furthermore,althoughreliableinformationregardingwhichnanomaterialsarecurrentlyon
themarket isvery limited,availablestudiesshowthatthe parentsubstancesofmanynano
materials(i.e.,thosewithwhichtheysharetheircorechemicalcomposition)arerelativelycom
mon31andpreexisting inbulkform. Infact,a2008study
32foundthatforadatabaseofcon
sumerproductscontainingnanomaterialscurrentlyonthemarket,onlysixparentsubstances33
wereused,allwithphaseinstatus.Itfollowsthatunderthecurrentrules,thevastmajorityof
Thisresultsinnanomaterialsenteringandremainingonthe
market with little or no information available regarding
theirpotential
risks,
in
direct
contradiction
with
the
no
data,nomarketprincipleunderlyingREACH.
30EuropeanChemicalIndustryCouncil(Cefic),RiskAssessmentofnanomaterialsfromanindustryperspective,
availableathttp://ec.europa.eu/health/nanotechnology/docs/ev_20110329_co12_en.pdf31Millieu,Risk&PolicyAnalysts(RPA),InformationfromIndustryonappliednanomaterialsandtheirsafety:Deliv
erable1,preparedforEuropeanCommissionDGEnvironment,September2009,available@http://
www.nanomaterialsconf.eu/documents/Nanos Task1.pdf.32Hansenetal.,Categorization FrameworktoaidExposureAssessmentofNanomaterialsinConsumerProducts,
Ecotoxicology,Vol.17No5,July2008,43844733Silver,Carbon(allallotropes),ZincOxide,Silica,Titaniumdioxideandgold.
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nanomaterialscurrentlymarketedbenefitfromphaseinstatus,delayingregistrationdeadlines.
Thisresultsinnanomaterialsenteringandremainingonthemarketwithlittleornoinformation
availableregarding theirpotentialrisks, indirectcontradictionwiththenodata,nomarket
principleunderlyingREACH.ThisunderminestheeffectivenessandcredibilityofREACHasthe
primaryregulatorytooltobridgetheknowledgegaponnanomaterials.
3.3Tonnagethresholds
Productionvolumesplaya significant role indeterminingwhetherandhow substances
areaccountedforunderREACH.Thegeneralruleofthumb isthatthehigherthevolume,the
moredata is required,and thesooner the registration.34Regulatory thresholdsarebasedon
fourtonnagebands(1 10tonnes,10100tonnes,1001,000tonnes,and1,000+tonnes).
Registrationofnanomaterials iskeytotheirregulationsince itallowsforthecollectionof
thenecessaryinformationfundamentaltotheapplicationofotherREACHmechanisms,suchas
restriction and authorisation.Moreover, the information provided on nanomaterials under
REACHhas significancebeyondREACH itself.According to theCommission, this information
will serve as input to other regulation, such asworker protection, cosmetics and environ
mentalprotection[and]complementsproduct legislation (e.g.,generalproductsafety)tothe
extentthatthisdoesnotcoverenvironmentalaspects.35
EversinceREACHwasadopted,therelevanceofREACHtonnagethresholdstonanomateri
alshasbeenquestioned.36Ineffect,therequirementforregistration laiddown inArticle6(1)
34Thereareexceptionstothisprinciplesrelatingtotheregistrationofsubstancesmeetingcertaintoxicitycriteria
(i.e.:Carcinogen,Mutagen,Reprotoxic,Persistentorbioaccumulative). Thisexceptionishowevernotdeemed
relevantinthecontextofthepresentstudy,asenduringdatagapprecludethatanynanomaterialsbetheobject
ofsuchtoxicityclassificationinthenearfuture.35CommissionNanomaterialsRegulationReview2008,supranote1,at5.
36Seeforexample:M.Fhr,A.Hermann,S.Merenyi,K.Moch,M.Moller,Legalappraisalofnanotechnologies,
Existinglegalframework,theneedforregulationandregulativeoptionsataEuropeanandnationallevel.Final
Report,UBA,2006,atsection5.3.1availableathttp://www.umweltdaten.de/publikationen/fpdfl/3198.pdf;
CommissionNanomaterialsRegulationReview2008,supranote1,at3:currentlegislationmayhavetobemodi
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ofREACHappliesonlyforproductionvolumesofonetonneormoreperyearpermanufacturer
or importer.Reliable informationon theproductionvolumesofnanomaterials isveryscarce,
andhamperedbythelackofdefinitiveinventoryonthetypesandusesofnanosubstances.37
Basedontheverysmallquantities inwhichnanomaterialsaremarketed,38however, itseems
likely that theproductionand importofmostnanomaterialswould fallbelow theone tonne
thresholdrequiredforevenbasicregulationunderREACH.It thereforemustbeassumedthat
thestandardprincipleinArticle5ofREACHNodata,nomarket"isineffectivewithrespectto
manynanomaterials.39TheGermanAdvisoryCouncilontheEnvironment(SRU)suggeststhata
coredatasetshouldstillhavetobesubmittedifananomaterialisproducedinquantitiesofless
than1tonneperyear.40
Even in the few cases inwhich nanomaterials are produced in volumes above the one
tonne/yearperregistrantthreshold,mostnanomaterialswillstillbenefitfromphaseinstatus
derivedfromtheirbulkcounterparts.41Consequently,theinformationsetrequiredbytheregis
trationdossierwillbelimitedtothephysicochemicalpropertiesofthesubstance,excludingany
toxicologicalandecotoxicologicalinformation,42whichmayotherwiseberequired. Norwillit
includeexposure information,which isonly required for substancesofveryhigh concern.43
Similarconcernsapplytotheavailabilityofinformationdownthesupplychain.44
AdetailedCSA,whichmandateshumanhealth,physicochemical,andenvironmentalhaz
ard assessment, is onlymandated for substancesmanufactured or imported above the ten
37
R.G.Lee&S.Vaughan,supranote199,at15.38See,forexample,thesubstanceofmanufacturerSigmaAldrich,catalogueno.519308Carbonnano tube,sin
glewalledCarboLexAPgrade5070%purityasdeterminedbyRamanspectroscopy,tubesinbundleoflength
about20m,whichissoldinquantitiesof0.25gor1gv(pricefor1g:250.70euros),inM.Fhretal.,supra
note366,atsection5.3.2.4,6.1.2.1.39M.Fhretal.,surpranote36,at43,6.1.2.1.
40GermanAdvisoryCouncilontheEnvironment(hereinafterSRU),PrecautionaryStrategiesforManaging
Nanomaterials,SummaryforPolicyMakers,Sep2011,at6.41Seesupra,Section2.2
42REACH,AnnexVII.
43REACH,Art14(3).
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tonne threshold/yearbya single registrant.45 Becausemostnanomaterialsare likely topro
ducedinlowvolumes(underthe10tonnethreshold),CSAwillbeunavailableforthegreatma
jorityofnanomaterials.
3.4Riskassessmentprovisions
REACHrulesfortheprovisionofphysicochemical,toxicologicalandecotoxicologicaldata,
aswellasCSAperformancecriteriareflectmethodologiesdevelopedfortraditionalsubstances.
Severalcommentatorshavehighlightedtheneedtomodifyboththerulesandtheimplementa
tionguidelinesinordertoeffectivelyaddressthespecialrisksposedbynanomaterials.46
TheScientificCommitteeonEmergingandNewlyIdentifiedHealthRisk(SCENIHR),inpar
ticular,mentions that thereareanumberofareaswhere theriskassessmentsasoutlined in
REACH,andexplainedingreaterdetailintheECHA2011Guidance,47mayneedmodificationto
giveacompletepictureoftheriskspresentedbysubstances inthenanoform.48SCENIHRob
serves, forexample, that theuptake,distribution,clearanceandeliminationofnanoparticles
maydifferfromthoseofthechemicalsubstancesforwhichtheTGDswereinitiallydeveloped.
It isuncertainwhetherthebasesetofstandardtestsandrecommendedproceduresareade
quate to assesseffectsofnanoparticles.49 Specifically, the traditionalmethodsofmeasuring
45Seearticle10ofREACH,aswellasannexesVIandVII,7.
46SeeTheNetherlandsNationalInstituteforPublicHealthandtheEnvironment(RIVM),Exposuretonanomateri
alsinconsumerproducts,RIVMLetterReport340370001/20998, 2009,at12,whichpointsoutthatthesubmis
sionofkineticinformation,whichisnecessarytoproperlyassessnanoformsubstances,isnotrequiredunder
REACH.RIVMalsocallsforREACHexposuremodelstobeadaptedtonanoformsubstancesandforits"standarddefaultassessmentfactorstobeexaminedfortheirapplicability tonanomaterials"Otherimportantworkon
thetopichasbeendonebytheScientificCommitteeforEmergingandNewlyIdentifiedHealthRisks,Opinionon
theappropriatenessoftheriskassessmentmethodologyinaccordancewiththeTechnicalGuidanceDocuments
fornewandexistingsubstancesforassessingtherisksofnanomaterials,Brussels:EuropeanCommissionHealth
&ConsumerProtectionDirectorateGeneral,28(June2007),availableathttp://ec.europa.eu/health/ph_risk/
committees/04_scenihr/docs/scenihr_o_010.pdf (hereinafterSCENIHR2007)47EuropeanChemicalsAgency(ECHA),GuidanceforidentificationandnamingofsubstancesunderREACHand
CLP,November2011,Version1.1(hereinafterECHA2011Guidance),availableathttp://
guidance.echa.europa.eu/docs/guidance_document/substance_id_en.pdf?time=1323858278.48SCENIHR2007,supranote46,at11.
49SCENIHR2007,supranote46,at48.
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andevaluatingthedoseresponserelationship,relyingonmassasanindicatorofexposureand
toxicity,was found to be inappropriateby the scientific committee.50 Exposure assessments
werealsofoundtorequiremodificationstoreflectthephysicochemicalcharacteristicsofnano
materialsand theirpotential tochange throughout the substance's lifecycle.51 Indeed, since
thesenanomaterialsmay, forexample,accumulate inareaswith increasedpermeabilityand
crossbarrierssuchastheolfactorymucosaorthebloodbrainbarrier,52morecomplexriskas
sessmentproceduresarenecessaryfornanomaterials.53
This problem remains even under themost stringent requirements for the 1000 tonne
threshold.SCENIHRopinesthat,"[o]nthebasisofcurrentknowledge,theriskcharacterization
ofbulkmaterialsasdescribedintheTGD54cannotbedirectlyextrapolatedtonanomaterials."
55
Therequiredtestingandinformationsubmissionmaynotidentifyitstruerisksduetothelimi
tationsofconventionalmethods.56Asitstands,REACHsfailuretodistinguishbetweenthebulk
andnanovariantsof a substancewhen assessing their risks implicit[ly] (and inaccurate[ly])
[assumes]thattheriskofasubstanceisthesameatwhateverscale.57
Industryhasoftenarguedthattheabsenceofdataonthefateandeffectofnanoparticles
ontheenvironmentandhumanhealthrendersitinfeasibletoproposefirmrulesonhowsub
stances should be evaluated. By this argument, existing rules and assessmentmethods for
50SCENIHR2007,supranote46,at11.
51ibid.
52
M.Semmler,etal.2004,WG.Kreylingetal.2006,Oberdorster2004,Elder2006,as
perSCENIHR2007,supranote46,at17.53SCENIHR2007,supranote46,at34....thesafetyevaluationofnanoparticlesandnanostructurescannotrely
onthetoxicologicalandecotoxicologicalprofileofthebulkmaterialthathasbeenhistoricallydetermined.54Availableathttp://ihcp.jrc.ec.europa.eu/our_activities/healthenv/risk_assessment_of_Biocides/doc/tgd.
55SCENIHR,supranote46at26.
56A.Franco,S.F.Hansen,S.I.Olsen,L.Butti,LimitsandProspectsoftheIncrementalApproachandtheEuropean
LegislationontheManagementofRisksrelatedtoNanomaterials,RegulToxicoPharm48:171183(2008),at
171;Craneetal.2008,Powelletal.2008,Shatkin2008,asperK.D.Grieger,A.Baun,R.Owen,Redefiningrisk
researchprioritiesfornanomaterials,2JournalofNanoparticleResearch12:383392,at384.57R.G.Lee&S.Vaughan,supranote199,at14.
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chemicals in thebulk form should remainequally applicable tonanomaterials.58 The lackof
datashouldnot,however,justify theuseofconventional rulesandassessmentmethods. In
deed,theREACHframeworkisnotcapableofestimatingthehealthandenvironmentalrisksof
nanomaterials.59Thisisduenotonlytothetime,butalsotothecost,ofresearchtogenerate
meaningfulresults.60
Giventhese limitations,REACH in itscurrentformdoesnotequipdecisionmakersforef
fectivenanoregulationbecause itwould lead todecisionsbasedonhazardandexposureas
sessmentmethodsillsuitedtoproperlyassesstherisksofnanomaterials.
Indeed, theUnitedKingdomsRoyalCommissiononEnvironmentalProtection (RCEP)has
highlightedthatREACHmayactuallyhaveanindirectbutadverseeffectonriskdatageneration
fornanomaterials.61Under thecurrentregime, ifabulksubstance ischaracterizedashazard
ous, thesupplierwillberequired toprovide further informationon thenatureof thehazard
andthepossiblerisksinvolved.Butifthematerialisnonhazardous,asisthecaseforthevast
majority of substances fromwhich nanomaterials are derived, this classificationwill be ex
tendedtothenanoformofthesubstance,withnoadditionalrequirementstogeneratedata
onspecificnanoformeffects.Fromthereon,thesubstancecouldmovethroughitsentirelife
cyclewithout further assessment, despite thepossibility that, although it isnot considered
harmfultohumanhealthortheenvironmentinitsapproveduse,itmighthavethecapacityfor
adverse impacts at someother stage, forexample, asa resultof releaseof theproductsof
abrasionorcombustion.62
58EuropeanChemicalIndustryCouncil(Cefic),RiskAssessmentofnanomaterialsfromanindustryperspective,
availableathttp://ec.europa.eu/health/nanotechnology/docs/ev_20110329_co12_en.pdf59K.D.Grieger,A.Baun,R.Owen,supranote56,at389.
60ibid.
61UKRoyalCommissiononEnvironmental Pollution,NovelMaterialsintheEnvironment:Thecaseofnanotech
nology,27thReport,November2008(hereinafterRCEP).
62RCEP,supranote61,at63,4.39.
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3.5Summary:Fourgapsregardingnano
withinREACH
REACH in itscurrent formdemonstrates fourdistinct
andsignificantgapswithregardtotheeffectiveregu
lationofnanomaterials:
1. AsREACHcurrentlystands, it is impossibletofor
mally identify a nanomaterial with consistency
acrosstheboard.Thiscreatesconfusionandseri
ousdoubtsasto thecapacityofREACH togener
atecomprehensivedataonnanomaterialscurrentlybeingmarketed.
2. SincesubstanceidentificationwithinREACH isexclusivelybasedonasubstanceschemical
composition,ananomaterialsharingthesamechemicalcompositionasanexisting(phase
in)bulksubstancewillautomaticallybenefitfromthebulkformsphaseinstatus,resulting
inadelayedregistrationdeadline.
3. Existing tonnage thresholds farexceed thequantities inwhichmostnanomaterialsenter
theEUmarket,thusgreatlylimitingtheinformationrequiredforregistrationofnanomateri
als.
4. Finally,and inadditiontotheforegoing limitations,anyriskassessment informationmade
available in the contextofREACHwould reston inadequate testingguidelines,very seri
ouslylimitingitspotentialutility.
IfregulatorsintendtouseREACHasthecornerstoneforaddressinghealth,safetyandenviron
mentalrisksofnanomaterials,63itisimperativethattheseshortcomingsberemedied.
Given these limitations,
REACHin
its
current
form
does not equip decision
makers for effective nano
regulation.
63Seesupranote5.
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SECTION
4
/
Addressing
the
nano
gaps:
the
limits
of
substance
identification
InanefforttoaddresstheseconcernsandevaluatetheapplicabilityofexistingTGD(and
ultimatelyofREACH) tonanomaterials, theCommission setup threeREACH Implementation
ProjectsonNanomaterials(RIPoN).ThefirstoftheseRIPoNs,addressesthespecificissuesre
volvingaroundsubstance identification.Havingsought todevelopscientificand technicalad
viceonhowtoestablishthesubstanceidentityofnanomaterials,theRIPoN1advisoryreport
highlightstheexistingdivergenceofopinionsontheadequacyofcurrentidentificationparame
ters,andpresentstwooptionsforadaptingsubstanceidentificationrulestonanomaterials:(1)
treatingnanomaterialsaswelldefinedsubstancesor(2)assubstancesofdefinedchemical
compositionandadditionalidentifiers.Yetthereportleavesunaddressedtheunderlyingques
tionsofhowtoadaptsubstance identityrulesunderREACHtonanomaterials.Nordoes itad
dressthematerialconsequencesthatselectingoneoranotheroftheoptionscanhaveonpo
tentialregistrationdossiersofnanomaterials.Thissectionexplorestheimpactofthesechoices
inaddressingtheinherentgapsidentifiedintheprevioussection.Asapreliminaryremark,itis
important toconsider thatguidancedocuments (including thoseon substance identification)
arenotbinding. Thus,ifadefinitionofnanomaterialweretobeincludedinsuchdocuments,
registrantswouldstillretainflexibilityindecidingwhethertousethisdefinitionintheirregistra
tionprocess.Modificationoftheguidancedocumentalonewouldthereforebe insufficientto
adaptREACHtoeffectivelyregulatenanomaterials.
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4.1NanomaterialsasWellDefinedSubstances
4.1.1Nanomaterialsderivedfromabulkchemical
Initscurrentform,REACHsubstanceidentificationrulesarebasedonchemicalcompo
sitionalone.64Consideringnanomaterialsaswelldefinedsubstances
65meansthatananomate
rialsharing thesamemolecularcompositionasachemical in thebulkformwillbeautomati
cally assimilated to itsbulk counterpart.As a consequence,other characteristicsof the sub
stance,suchas itssize,willnotbeconsidered identifiersforpurposesofsubstance identifica
tionunderREACH,butratherasacharacteriser.66Consequently,traditionalsubstance iden
tityruleswillapply;requiringnotonlythatthenanoandbulkversionsberegisteredasonesub
stance,butalso that thesubstances tonnage thresholdbecalculatedbasedon the totalvol
umeofsubstance(bothbulkandnanocombined)manufacturedor importedbyeachparty.67
Thishastwomainimplications.
First,theassimilationofthenanomaterialandthebulkasonesubstanceforregistration
purposesenables,intheory,theinclusionoftheformerunderREACHregulationbecauseofthe
combinedtonnage.Inpractice,however,thismaynotbeenoughtoremedytheproblemiden
tified insection3.3. Itwouldonlybringnanomaterials intotheREACHregime insofarasboth
thebulkandnanomaterialaremanufacturedor importedby thesame legalentity. Ineffect,
REACHtonnagethresholdsaredefinedbythevolumesapplicabletoeachpotentialregistrant.68
Incaseswherethenanomaterial ismanufacturedor importedbyadifferent legalentitythan
theonewhomanufacturesorimportsthebulk(regardlessofwhethertheyareregardedasone
substance)tonnagethresholdswillbeconsideredindependentlyfromoneanother.
64ECHA2011Guidance,supranote477,at14,4.1
65ECHA2011Guidance,supranote477at144.1;at18,4.2.
66AdvisoryReportfortheRIPoN1process,supranote22,at20,4.1.1.1
67CommissionFollowuptothe6
thREACHCAMeeting,supranote22,at6.
68REACH,Art6,12.
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Second,ifnanomaterialsareconsideredeffectivelyinseparablefromthebulksubstance,
the registration requirements under REACH provide registrantswith the flexibility to decide
whetherornot to include informationrelevant to thenanoform:There isnobindingobliga
tion.TheCommissionopines thatall relevant informationonnanomaterials,covering the
properties,usesandanyrelevantclassificationandlabellingshouldbeincludedinthedossi
ers.69However,REACHdoesnotcurrentlycontainsufficientlybindingrequirementstorequire
systematicandextensiveexaminationofnanomaterials intheregistrationdossier.The lackof
guidanceastowhatmayconstitutesuchrelevantinformationallowsregistrantsbroaddiscre
tion.Infact,whendeterminingwhat informationmayberelevantforpurposesofregistration
ofasubstance,AnnexVIstatesthatsimpleconsideration(asopposedtoanobligationtotake
intoaccount)ofanyinformationonexposure,useandriskmanagementmeasuresissufficient,
suggestingalenientapproachinincludingnanomaterials.
Similarlimitationsapplytotheobligationtoclassifyandlabelsubstances inthetechni
caldossier.70TheCommissionServicesandMemberStateCompetentAuthoritieshavedecided
inthecontextofthelegislationonnew71andexistingsubstances,
72thatthespecificproperties
ofnanomaterialsmaywarrant a different classification and labelling compared to the bulk
chemical,includingwhenthenanoformisderivedfromabulksubstance.73Despitethisde
termination, theClassification, Labelling andPackagingRegulation74 referred toby section4
AnnexVIofREACHcontainsnoprovisionswhichimposesuchduties.UndertheCLP,registrants
mustidentifytherelevantinformationrelatingtotheformsandphysicalstatesinwhichthe
substanceisplacedonthemarketandinwhichitcanbereasonablyusedforpurposesofhaz
69CommissionFollowuptothe6
thREACHCAMeeting,supranote22,at6.
70REACH,Art10(a)(iv).
71Directive67/548/EEC,NONS)
72Regulation(EC)793/93,ESR
73CommissionFollowuptothe6
thREACHCAMeeting,supranote22at8.
74Regulation(EC)No1272/2008oftheEuropeanParliamentandoftheCouncilof16December2008onclassifi
cation,labelingandpackagingofsubstancesandmixtures,amendingandrepealingDirectives67/548/EECand
1999/45/EC,andamendingRegulation(EC)No1907/2006(hereinafterCLPRegulation).
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ard classification. However, according to the text,75 identifiable data must be readily
available,meaningthat there isnoobligationtogeneratenewdataonagivensubstance.
Consideringpresentknowledgegapsonnanomaterialsandthenewnessofthetechnologies,it
canonlybeassumedthattheavailableinformationtowhichregistrantswillrefertointhe
dossierswillrelatesolelyoratleastoverwhelminglytothebulkformofthechemical.
Inaddition,whenactuallyevaluating thecollectedhazard information, theCLPonly re
quires thatregistrantsconsider,rather thanmandatorily take intoaccount, theforms,or
physicalstatesofthesubstance inthefinalclassificationdecision.76Itfollowsthat,contrary
totheviewsofindustryexpertsaspresentedintheRipoN1advisoryreport,thereisnobind
ing obligation to include nanospecific properties such as size, in the classification of sub
stancesundertheCLPRegulation,andbyconsequenceintheregistrationdossier.77
Even the registrationdossierupdate requirementmay not adequately compensate for
informationdeficientprovisions. Therequirementtoupdatetheregistrationdossier istrig
geredwhenregistrantsareawareorreasonablyexpectedtohavebecomeawareof[changes
in] quantitiesmanufactured or imported, new uses or new knowledge of risks to human
healthortheenvironment.78Withonlytheabilitytorelyonthe(available)toxicologicalpro
fileof thebulkmaterial,andwithoutnanoadequate testguidelines toproducemeaningful
results,itisunclearhowcompaniescaneffectivelyfulfilthisobligationandresolvethetension
betweenintentofREACHanditstext.79
75
CLPRegulation,Art5.76CLPRegulation,Art9.
77theindustryexpertsarguethatsubstanceidentityisbasedonmolecularidentity,notonphysicalproperties
()Therefore,sizeascharacterizershallbeusedtodetermineappropriateclassificationundertheCLPRegula
tionaspertheAdvisoryReportfortheRIPoN1processsupranote22,at2078REACH,Art22.
79S.F.Hansen,RegulationandRiskAssessmentofNanomaterials:TooLittle,TooLate?20(Feb2009)(PhDThesis,
TechnicalUniversityofDenmark),availableathttp://www.nanolawreport.com/Steffen%20Foss%20Hansen%
20PhD%20Thesis%20webversion.pdf,at20.
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Asaconsequence,thisapproachtowardssubstance identification,whichmaintainsthat
substancesofsimilarchemicalcompositionshouldberegardedasidenticalforregulatorypur
poses,isinappropriate.Thisisespeciallytrueinviewoftheprecedentsoutsidethenanomate
rialscontextinwhichotherconventionalsubstanceswithsimilarchemicalcompositionshave
beenfoundtobedifferentandthereforehavebeenidentifiedassuch.80
4.1.2Nanomaterialswithnocorrespondingbulksubstance
Inthiscase,nanomaterialswouldberegisteredintheirownright.Anumberofissues
wouldhowever remain. Inparticular, issuesexistrelating to thebindingnatureof theguid
ancedocument,81 issuesarisingfromthephaseinstatusofmostnanomaterialscurrentlyon
themarket,82tonnagethresholds,
83andtheadequacyoftestguidelinesandriskassessment
provisions.84
80Swedishexpert,theAdvisoryReportfortheRIPoN1process,supranote22,Appendix1.
81SeesupraintroductiontoPartIII.
82Seesuprasection2.2
83Seesuprasection2.3
84Seesuprasection2.4
Thereisnobindingobligationto
includenanospecificproperties
suchassize,intheclassification
ofsubstancesundertheCLP
Regulation,andbyconsequence
intheregistrationdossier.
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4.2NanomaterialsasSubstancesofDefinedChemicalCompositionandAddi
tionalIdentifiers
Asdemonstratedabove,whilegenerallywelldefined substancescanbecompletely
identified by [their] chemical composition,85 there are other circumstances inwhich they
needtobefurtherspecifiedbyadditionalidentifiers.86Thismaybetrue,forexample,when
substancesproperties. . .differsignificantlyforreasonsotherthanchemicalcomposition.
Through the TGD, REACH thus distinguishes between well defined substances and
substances of defined chemical composition and additional identifiers. Likewelldefined
substances, substances of defined chemical composition can be either mono or multi
constituent,87butrequireotherparametersforproperidentification.
Designating the nanomaterial as a substance of defined chemical composition with
additional identifiersmeansthatthesubstancecannotbeadequatelydefinedatthenano
scalebychemicalcompositionparametersalone.Althoughamanufacturedorimportedbulk
substancewiththesamechemicalcompositionmayexist,thenanoformisrecognizedasre
quiringadditionalidentifierstobepreciselyidentified.Thisclearlysetsitapartfromthebulk
form, even though the bulk form itselfmay also possess additional identifiers. In concrete
terms,thiswouldpermittherecognitionofthenanosubstanceinitsownright,independent
frompreexistingbulkforms,makingdistinctregistrationspossible.
Bydesign,engineerednanomaterialsaretypicallymanufacturedfortheiruniqueproper
tiespreciselybecausesuchpropertiesdifferfromthoseofbulksubstances. Thisamplyjusti
fiesdiscriminationonthebasisofsize.88ThisanalysisissupportedbySCENIHRsopinionthat
85ECHA2011Guidance,supranote47at14.
86ECHA2011Guidance,supranote47at24,4.2.3.
87SeeECHA2011Guidance,supranote47at21,table4.1foraclarificationoftheconceptofthemulti
constituentsubstance.88Swedishexpert,RIPoN1,supranote22Appendix1,at67.
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28 JustOutofREACH
themechanisms of toxic effects of engineered nanoparticlesmaybe dominated by those
characteristicsspecificallyintroducedinordertomeettheintendedfunctionoftheproductof
interest(),therefore,anyunpredictedinteractionsbetweennanoparticlesandbiologicalsys
temsmaydependon theiruniquephysicalandchemicalpropertiesand theirmultiple func
tionalities.89Byusingsizeasanidentifierratherthanacharacterizer,ananomaterialwith
thesamechemicalcompositionasabulkmaterialwouldberecognizedasauniquesubstance
thatwouldneedtoberegisteredonitsown.Thispolicydecisioncouldleadtoadifferentim
plementationofthephaseinprovisions,bynotautomaticallyextendingthebulkformsphase
instatustothenanoform.Itwouldthusprovideasolutiontothegapidentifiedinsection2.2.
However, suchapolicydecisionwould fall shortofaddressing the shortcomingsof the
Regulationidentifiedinsection3.1,3.3and3.4.Furthermore,assubstanceidentificationrules
aredefined inTGDs,90which arenonbinding innature, implementationof such adecision
wouldstillbewithinthediscretionofeachregistrant.
In summary, although thedecision to consider size as an identifier in the contextof
REACHsubstance identificationwouldpotentially lead toanearlierregistration,suchanop
tionwouldnotfullyclosetheexistinggaps intheRegulation inrelationtonanomaterials. In
particulartheproblemsrelatedtotheexistingtonnagebandrulesandtheinadequacyofthe
traditionalriskassessmentmethodspersist.Afurtherissuerelatestothenonbindingnature
oftheTGDs.MakingREACHthecornerstoneforaddressinghealth,safetyandenvironmental
risksinrelationwithnanomaterialswillthereforerequireamoresubstantialmodificationof
thecurrentregulatoryframework.
89SCENIHR,supranote23,at26.
90ECHA2011Guidance,Supranote47at14,4.
MakingREACHthecornerstoneforaddressinghealth,
safety and environmental risks in relation with nanomaterials will therefore require a more substantial
modificationofthecurrentregulatoryframework.
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SECTION
5
/
Policy
recommendations
AlthoughREACHprovidesagoodfoundationforregulatingconventionalchemicalswithin
theEU,acloser lookat itsmechanismsrevealssignificantdeficiencieswithrespecttonano
regulation.91REACHtools,whicharedefactoapplicabletonanomaterials,cannotbridgethe
existinginformationgapuntiltheyareadaptedtothespecificcharacteristicsofnanomaterials.
AsnotedbytheEuropeanParliament,lackofappropriatedataonthesafetyanduseofmar
keted nanomaterials jeopardizes the concept of a safe, responsible, and integrated ap
proach92tonanotechnologiesadvocatedbytheEuropeanUnion,preventingratherthanpro
motingtheprotectionofhealth,safety,andtheenvironment.
The previous sections demonstrate that addressing the shortcomings identified in this
studywillrequiremorethanjustupdatingtheREACHTGD.Thissectiondiscussestwopolicy
optionsforfillingthegapandexplorestheadvantagesanddisadvantagesofeachoption.
Option1:ModifyingtheREACHtext,itsannexesandTGDs
The first option for addressing the regulatory shortfalls described hereinwould be to
modifytheREACHregulationbyinsertingspecificprovisionsapplicabletonanomaterials:
Inordertoeffectivelysolvetheidentificationissuerelatedtosubstancesinnano
form, a definition of nanomaterial should be included in the REACH text. The
Commissionhas,afteryearsofdebate,nowputforwardarecommendationfora
nanomaterialdefinition.Thedefinition is intendedtoprovideclearandunambi
guouscriteriato identifynanomaterialsforwhich itmightbenecessarytoapply
specificprovisions, suchas those relating to riskassessment.93Suchadefinition
91ViewthatisalsosupportedbytheEuropeanParliament,seeResolutionof24April2009onRegulatoryAspects
ofNanomaterials(2008/2208(INI)),P6_TA(2009)0328(hereinafterEUParliament2009Resolution).92EUParliament2009Resolution,supranote89.
93SeeDGEnvironment,Definitionofnanomaterial,availableat:http://ec.europa.eu/environment/chemicals/
nanotech/index.htm
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shouldbe included inArticle3ofREACH,next to thegeneral substancedefini
tion.
Inordertospecificallyaddressthedelaysarisingfromphaseinstatusoutlinedin
Section3.2of this study,Article3(20) should further specify thatnanomaterials
arenotconsideredphaseinsubstances.
Inordertoaccountforthe lowproductionvolumeofmostnanomaterialsonthe
marketandensurethatacoredataset issubmittedevenfornanomaterialspro
ducedinquantitiesoflessthan1tonneperyear,the implementationoftonnage
triggersshouldbeadaptedtonanomaterials.Tothisend,anArticle7(4)bisshould
beintroducedwithspecifictonnagetriggersforsubstanceswithinthescopeofthe
definition of nanomaterials. Thismodificationwould, in turn, require a corre
spondingmodificationofArticle6.
Furthermore, it is necessary tomodify Article 14(1) to require that registration
dossiersfornanomaterialscategoricallyincludeaCSA,inordertorespondtoexist
ingconcernsrelatingtothetoxicityofsomenanomaterialsandtheexistingknowl
edgegap,andinordertoreachthehighlevelofprotectionofhumanhealthand
theenvironment.
Finally,toadaptthetestingrequirementsandriskassessmentproceduresapplica
ble tonanomaterials, thusaddressing thegapoutlined inSection3.4whilealso
complyingwith the recommendations fromSCENIHR,94 it isnecessary toupdate
testingand riskassessmentprovisionsand implementationguidelines to include
specificnanomaterialsprovisions.Thislastchangewouldrequiremodificationsof
AnnexesVItoXaswellasTGDs.
94SeeSCENIHR,ModifiedOpinion(afterpublicconsultation)onTheappropriatenessofexistingmethodologiesto
assessthepotentialrisksassociatedwithengineeredandadventitiousproductsofnanotechnologies, 10March
2006,availableathttp://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf
(hereinafterSCENIHR2006),at4,statingSCENIHRconcludesthatcurrentriskassessmentmethodologiesre
quiresomemodificationinordertodealwiththehazardsassociatedwithnanotechnology andinparticularexist
ingtoxicologicalandecotoxicologicalmethodsmaynotbesufficienttoaddressalloftheissuesarisingwith
nanoparticles;SCENIHR,RiskAssessmentofProductsofNanotechnologies,19January2009,availableathttp://
ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf,at7,stating,theknowledgeand
methodologyforbothexposureestimationsandhazardidentification needstobefurtherdeveloped,validated,
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These considerations focus on the registration process. Furthermodifications of other
REACHprovisionsoritsannexesandTGDs(e.g.,adaptationoftheconceptofmulticonstituent
substancestoaccountforcoatednanomaterials)mightbenecessarytoadaptotherelements
oftheregulationandwouldrequirefurtheranalysis.
ConsideringthecomplexityofREACHrevisionprocesses, inparticularfortherevisionof
thecoreofthetext,anumberofstakeholders,includingtheCommission,havequestionedthe
advisabilityand/or feasibilityofrenegotiatingREACH itself. In thiscontext, theyrecommend
addressing the identified shortcomingsofREACH, inparticular in relation tonanomaterials,
throughalternativemethods.
Option2:Developingastandaloneregulation
InordertoavoidmodifyingREACHitself,whileensuringitseffectivenessinaddressingthe
uniquecharacteristicsofnanomaterials,itispossibletoaddananopatchtotheregulation
intheformofastandaloneregulation. SucharegulationwouldspecifyhowREACHtoolsand
provisionsshouldbeappliedwith respect tonanomaterials. Tobeeffective, theregulation
shouldincludethefollowingbasicelements:
Apreamblethatsetsforthgeneralprinciplesforthemanagementandgovernance
ofnanomaterialsandindicatethatalltermsareusedinaccordancewiththeirdefi
nitioninREACHexceptasotherwiseexpresslyprovided;
Adefinitionofnanomaterials (ornanosubstance toadhere toREACH termi
nology)inaccordancewiththedefinitionproposedbytheCommission;
AspecificationforhowtheREACHconceptofmulticonstituentsubstancewillbe
appliedtonanosubstances,toaddresstheissueofcoatednanomaterials;95
95SeeforexampleETUC:ETUCconceptofaregulatorydefinitionofasubstanceinthenanoformavailableat:
http://www.etuc.org/IMG/pdf/REACH_nanosubstance_definition_ETUC_concept.pdf
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Arequirementthatallmanufacturersandimportersofnanomaterialsinquantities
overanappropriatetonnageshallsubmitaregistrationtoECHA (10kg isconsid
eredanappropriateprecautionarythresholdstoaccountfornanomaterialsspeci
ficities while limiting unnecessary burden), together with subsequent tonnage
thresholdstoimplementtheREACHincrementalapproach.
The specifics of the registrationwould be crossreferenced to the relevant section in
REACHandadaptedwherenecessary.Asanexample,suchadaptationwouldrelatetospecific
tonnagetriggers,registrationdeadlinesandotheraspectssuchastherequirementforaCSA.
Similarly, the regulationannexeswould specify, via a crossreferencemechanism toREACH
annexes,wheretherelevantsectionswoulddifferfornanomaterials.Specific informationre
quirementsanddeviationfromtheoriginalREACHannexesprovisionswouldrequirefurther
refinement,whichcouldbetheobjectofasimilarsubsequentstudy.
A stand alone nanopatchwould provide a simple and elegant solution for adapting
REACHtothespecificitiesofnanomaterials. Itcouldfurthermorebeconceivedasflexible in
strument with simplified revision procedures. It would thus be possible to adapt nano
regulationregularlywithoutaddingfurtherlayersofcomplexitytoREACH.
A stand alone nano patch
would
provide
a
simple
and
elegantsolutionforadapting
REACH to thespecificitiesof
nanomaterials.
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SECTION6/Conclusion
ThereisnodoubtthatREACHprovidesanincrementalapproachthatcouldbeveryuseful
in collectingmuch needed information regarding nanomaterials and implementing further
managementmeasures.Astheregulationcurrentlystands,however,itcontainsgapsthatren
deritcompletelyineffectivefortheregulationofnanomaterials.Thesegapsallownanomate
rials toenter theEUmarketwith littleorno informationavailable regarding theirpotential
risks,indirectcontradictionwiththenodata,nomarketprinciple.
Effortstoaddresstheseissueshavebeenundertaken,butproposalsfallshortofproviding
adequatesolutions.Todate,alloftheseproposalshavefocusedonusingthenonlegallybind
ingguidancedocuments toaddress thesegaps.Ouranalysisdemonstrates that revisions to
theseguidancedocumentsalonewillbeinadequatetoaddressgapsandshortcomingspresent
intheregulationitself.WhilerenegotiatingREACHtoincludespecificprovisionsonnanotech
nologywouldbetheoreticallyfeasible,itappearspracticallyimpossible,aswellasinadvisable
inthecurrentpoliticalcontext.
Analternativesolutionbetteradaptedtothespecificcontextofnanomaterialsisavail
able in the formastandalonenanopatch toREACH thatwould tailor theREACHmecha
nismstonanomaterials.Suchastandaloneregulationwouldestablishclearandlegallybind
ingprovisionsapplicabletonanomaterials,thusprovidingatransparentandcertainlegalenvi
ronmentforthesafeproductionanduseofnanomaterialsintheEUwithoutaddingcomplex
itytothealreadycomplexinstrumentthatisREACH.Thissolutionwouldhavethefurtherad
vantageofbeingmoreflexible,andwouldmake itpossibletoadaptthe legalframeworkfor
nanomaterialsmoreeasilyasourunderstandinggrows. CIEL is looking forward toworking
withall interestedpartiesandstakeholders todevelopablueprint forsuchananopatch
and fully realizeREACHspotentialas the regulatory cornerstone foraddressing thehealth,
safetyandenvironmentalrisksofnanomaterials.
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