You are on page 1of 37

Just Out

of REACH

How REACH Is Failing to


Regulate Nanomaterials
and How it Can Be Fixed

JustOutofReach

6February2012

DavidAzoulay,
ManagingAttorney,GenevaOffice,Switzerland
TheCenterforInternationalEnvironmentalLaw(CIEL)
+41223214774
dazoulay@ciel.org
www.ciel.org

AboutCIEL

Foundedin1989,theCenterforInternationalEnvironmentalLaw(CIEL),usesinterna
tionallawandinstitutionstoprotecttheenvironment,promotehumanhealth,anden
sureajustandsustainablesociety.WithofficesinWashington,DCandGeneva,CIELs
staffofinternationalattorneysworkintheareasofhumanrightsandtheenvironment,
climatechange,lawandcommunities,chemicals,tradeandtheenvironment,interna
tionalenvironmentalgovernance,biodiversityandinternationalfinancialinstitutionsby
providinglegalcounselandadvocacy,policyresearchandcapacitybuilding.

TableofContents

ExecutiveSummary _________________________________________________________1
Listofacronymsandabreviation ___________________________________________________ 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

ExecutiveSummary

MorethanthreeyearsaftertheEuropeanCommissionscommunicationontheregula

toryaspectsofnanomaterials,numerousquestionsremainregardingthepracticaleffectiveness
ofexistingEuropeanUnionlawtomanagenanomaterials.REACH,theprimaryEUregulationon
chemicals, is assumed to be the regulatory cornerstone for addressing the health, safety and
environmentalrisksofnanomaterials.Inparticular,REACHregistrationisdescribedastheideal
tooltofilltheproblematicknowledgegaponnanomaterials.However,thelimitedinformation
gathered in the first registration phase demonstrates that REACH is not living up to expecta
tionsfornanomaterials.

ThestudyidentifiesfourareasinwhichREACHsregistrationprovisionsfailtoaccount

forthespecificitiesofnanomaterials:

1.Identifyingnanomaterials:REACHcurrentlydoesnotdefinenanomaterialsandleavestothe
registrantthefinaldecisionofdeterminingwhetherasubstanceisananomaterial.Asaresult,
thefinaldecisiontoidentifysubstancesasnanomaterialsismadebytheregistrantsaccording
to their own criteria. In addition to creating confusion in the implementation of REACH, this
situationislikelytoseverelyimpaireffortstouseREACHasthemainregulatorytoolforgather
ing information on nanomaterials on the market and defining and implementing appropriate
riskmanagementmeasuresifneeded.

JustOutofREACH

The limited information gathered in the first


registration phase demonstrates that REACH is
notlivinguptoexpectationsfornanomaterials.


2.Phaseinstatusofnanomaterials:REACHdistinguishesnewandexistingsubstances,between
substancesthatwerealreadyonthemarketbeforeitsentryintoforce(socalledphaseinsub
stances)andnewsubstances(socallednonphaseinsubstances).AsREACHiscurrentlyimple
mented,ifamaterialisconsideredaphaseinsubstanceinitsbulkform,thenananomaterial
sharingthesamechemicalcompositionwillautomaticallybenefitfromthebulkversionsphase
in status, regardless of its newness. As a consequence, nanomaterials derived from a bulk
phasein substance, or sharing the same chemical composition, will not be registered before
the 2013 deadline if they are manufactured or imported in quantities above 100 tonnes per
yearperregistrant.Suchmaterialsmanufacturedorimportedinquantitiesof1100tonnesper
yearperregistrantwillnotberegistereduntil2018,furtherextendingtheknowledgegapsur
roundingnanomaterials.Becausemostnanomaterialscurrentlyonthemarketarederivedfrom
parentsubstancesthatbenefitfromaphaseinstatus,thevastmajorityofnanomaterialscur
rentlymarketedbenefitfromdelayedregistrationdeadlinesindirectcontradictionwiththeno
data,nomarketprincipleunderlyingREACH.

3.Tonnagethresholdsandnanomaterials:Productionvolumesplayasignificantroleindeter
miningwhetherandhowsubstancesareaccountedforunderREACH.Theoverallruleofthumb
is that the higher the volume, the more data is required, and the sooner the registration.
REACHregistrationrequirementsapplyonlyforproductionvolumesofonetonneormoreper
yearpermanufacturerorimporter.Thisvolumethresholdisgrosslyinadequatefornanomate
rials,usuallyproducedinmuchsmallerquantities.Furthermore,inthefewcasesinwhichnano
materialsareproducedinvolumesabovetheonetonne/yearperregistrantthreshold,mostof
thosenanomaterialswillbenefitfromaphaseinstatus.Asaresult,theinformationrequired
bytheregistrationdossierwillbelimitedtothephysicochemicalpropertiesofthesubstance,
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.

JustOutofREACH


4. Risk assessment provisions: According to the Scientific Committee on Emerging and Newly
Identified Health Risks (SCENIHR) and independent researchers, and notwithstanding other
limitationsdiscussedabove,anyriskassessmentinformationmadeavailableonananomaterial
inthecontextofREACHwouldbebasedontestingguidelinesthatfailtoconsiderthespecial
hazardsandexposurepathwaysofnanomaterials.Furthermore,ifabulksubstanceischarac
terizedasnonhazardous,asisthecaseforthevastmajorityofsubstancesfromwhichnano
materials are derived, this classification will be extended to the nanoform of the substance,
withnoadditionalrequirementstogeneratedataonspecificnanoformeffects.Therefore,a
nanomaterialcouldmovethroughitsentirelifecyclewithoutfurtherrequirementstoassessits
properties.Giventheselimitations,REACHinitscurrentformdoesnotequipdecisionmakers
tomanagetherisksofnanomaterials.

SeveralREACHImplementationProjectsonNanomaterials(RIPoN1,2and3)werede

signedtoaddresstheseconcernswithoutmodifyingthetextoftheregulation.RIPoN1,inpar
ticular, aimed at adapting the substance identification rules (defined in a Technical Guidance
Document(TGD))toclarifytheimplementationofREACHtonanomaterials.Thisexpertgroup
proposed two options: addressing nanomaterials as 1) well defined substances or as 2)
Substancesofdefinedchemicalcompositionandadditionalidentifiers.

Althoughtheseoptionsmightimprovethesituationtoalimitedextent,mostoftheis

sues identified above would remain. In particular, the problems related to the tonnage band
rulesandtheinadequacyofthetraditionalhazardandexposuretestingguidelinespersist.Fur
thermore, substance identification rules are not binding, so attempts to address the gaps for
nanomaterialsbymodifyingtheserulescouldcreateconfusioninimplementationandthwart
effortstouseREACHasthemainregulatorytoolfornanomaterials.IfREACHistoserveasthe
regulatorycornerstonefornanomaterials,itwillrequiremoreprofoundchangesoftheregula
toryframework.

JustOutofREACH

ThisstudypresentstwooptionsforalteringREACHtoaccommodatenanomaterials:

Option1:ModifyingtheREACHtext,itsannexesandtechnicalguidancedocuments
Addressing the regulatory gaps for nanomaterials identified in the registration process of
REACHwouldrequire,ataminimum:

Including a definition of nanomaterial in the REACH text, presumably in Article 3,


nexttothegeneralsubstancedefinition;

Specifying that nanomaterials are not considered phasein substances in Article 3


(20);

Introducingspecific(andsignificantlylower)tonnagetriggersforsubstanceswithin
the scope of the definition of nanomaterial as Article 7(4)bis. This modification
wouldrequireacorrespondingmodificationofArticle6;

ModifyingArticle14(1)torequirethatregistrationdossiersfornanomaterialscate
goricallyincludeaChemicalSafetyAssessment,inordertoreachthehighlevelof
protectionofhumanhealthandtheenvironment;and

Finally, updating testing and risk assessment provisions and guidelines to include
specificnanomaterialsprovisions,throughmodificationsofAnnexesVItoXaswell
astechnicalguidancedocuments.

These proposals would go a long way to ensure that the registration process under

REACH generates necessary information on nanomaterials. Additional modifications of other


REACHprovisions,annexes,andguidancewouldberequiredtoaddressshortcomingsofother
coreelementsofREACH,includingevaluation,authorisation,andrestriction.

InsteadofmodifyingREACHitself,apossiblealternative
for addressing nanomaterials would be to develop a
standalone regulation specifying how REACH tools and
provisionsaretobeappliedtonanomaterials.

JustOutofREACH


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.

JustOutofREACH

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

JustOutofREACH

SECTION1/Introduction

MorethanthreeyearsaftertheEuropeanCommissionscommunication1ontheregula
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

EuropeanCommission,CommunicationfromtheCommissiontotheEuropeanParliament,theCouncilandthe
EuropeanEconomicandSocialCouncilCommitteeontheRegulatoryAspectsofNanomaterials.Sec(2008)2036,
17June2008,availableathttp://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf(hereinafter
CommissionNanomaterialsRegulationReview2008).
2

EuropeanEnvironmentalBureau,EEBpositionpaperonnanotechnologiesandnanomaterials,Smallscale,big
promises,divisivemessages,February2009,at1.
3

ScientificCommitteeforEmergingandNewlyIdentifiedHealthRisks,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,Authorisationand
RestrictionofChemicalsRegulation,2007O.J.(L136)3,18(hereinafter"REACH").
5

CommissionstaffworkingdocumentaccompanyingdocumenttotheCommunicationfromtheCommissionto
theEuropeanParliament,theCouncilandtheEuropeanEconomicandsocialCouncilCommitteeontheregula
toryaspectsofnanomaterials.Com(2008)366final,17June2008,availableathttp://ec.europa.eu/
nanotechnology/pdf/com_regulatory_aspect_nanomaterials_2008_en.pdf.
6

Seee.g.,theNLCAreactionondocumentCaracal/58/2011,Brussels,20July2011onRipoN1;theFRCAcom
mentsondocumentCaracal/58/2011andquestionfromtheCommissiononthewayforwardconcerningtheJRC
finalreportonRIPoN1,1September2011;
7

EuropeanParliament,Resolutionof24April2009onRegulatoryAspectsofNanomaterials,(2008/2208(INI)),
P6_TA(2009)0328(hereinafterEUParliament2009Resolution).

JustOutofREACH


tions,8tradeunions9andenvironmentalorganizations10haveunderscoredtheneedtoadapt
REACH provisions and implementation processes to ensure that nanomaterials are subject to
the same information requirements and protections as other chemicals. The objective of this
studyistoexploreindetailhownanomaterialsaretreatedundertheRegistrationprovisionsof
REACHthatsupporttheprincipleofnodata,nomarket,andsuggestchangeswhereneeded.
RegistrationiscriticaltothefunctioningofREACHbecauseitgeneratesthefundamentalinfor
mation on which the safety of chemicals is judged. If nanomaterials evade Registration, or if
theiradverseeffectsareunderestimated,theremainingprovisionsofREACH,includingEvalua
tion,AuthorisationandRestrictions,couldbeundermined.Hownanomaterialsaretreatedun
dertheseotherprovisionsisbeyondthescopeofthisanalysis.

REACHisbasedontheprimaryunderstandingthatadequateinformationregardingeach
substance provides the basis for identifying and implementing risk management measures
whenneeded.

If nanomaterials evade Registration, or if


theiradverseeffectsareunderestimated,the
remaining provisions of REACH, including
Evaluation, Authorisation and Restrictions,
couldbeundermined.

SeeTheEuropeanConsumersOrganization(BEUC),TheEuropeanAssociationfortheCoordinationofCon
sumerRepresentationinStandardization(ANEC),Nanotechnology:Smallisbeautifulbutisitsafe?,ANEC&BEUC
leafletonnanotechnologyandnanomaterials,November2009,availableathttp://docshare.beuc.org/docs/1/
NKOLJLCBMGLDJPKAOEPCGOOGPDBG9DBW769DW3571KM/BEUC/docs/DLS/20090089301E.pdf,at6.
9

SeetheEuropeanTradeUnionConfederation(ETUC),ETUC2ndResolutiononnanotechnologiesandnanomateri
als,AdoptedattheExecutiveCommitteeon12December2010,availableathttp://www.etuc.org/IMG/pdf/13
GB_final_nanotechnologies_and_nanomaterial.pdf,at4,5.
10

SeetheEuropeanEnvironmentalBureau,EEBpositionpaperonnanotechnologiesandnanomaterials,small
scale,bigpromises,divisivemessages,February2009,availableathttp://www.eeb.org/EEB/?
LinkServID=5403FF15998845A30E327CBA2AFD88BA,at7,910.

JustOutofREACH


The absence of adequate, comprehensive information for nanomaterials is a major
problemfacedbyregulatorsinidentifyingandimplementingregulatoryprovisionsrelevantto
nanomaterials, and to make use of the full scope of REACH mechanisms. Registration under
REACH11isdesignedtoremedyexactlythiskindofknowledgegap,requiringthesubmissionof
essentialdataonallsubstancesmarketedintheEUtoenabletheapplicationofthemostap
propriate regulatory provisions. The successful implementation of REACH registration provi
sionstonanomaterialsisthereforecritical.

However,experiencefromthefirstregistrationroundstronglysuggeststhatregistration
ofnanomaterialshasbeenverylimitedandhasnotyethelpedsignificantlyinbridgingtheexist
ingknowledgegap.

This study will therefore focus on the adaptations to REACH needed to ensure that
nanomaterialsareproperlyregisteredandthattheregistrationphaseprovidestheinformation
necessarytofurtherimplementtheriskmanagementtoolsintegratedintheREACHframework.
After a brief summary of REACH provisions relevant to the registration of nanomaterials, the
studywillidentifyobstaclesandlegalshortcomingsthatimpedethesuccessfulregistrationof
nanomaterials, review the possible role of substance identification rules in addressing these
shortcomingsandproposepolicyoptionstoremedytheremaininggaps.

SECTION2/Keyregistrationprovisionsfornanomaterials

TheregistrationprovisionsofREACHarefoundedonthenodata,nomarketprinciple.

Theseprovisionsrequiremanufacturersandimporterstosubmitaminimumsetofinformation
onasubstanceinordertomarketthatsubstancewithintheEU.12Thisgeneralobligationtoreg
isternanomaterialsappliessolelyforthosemanufacturedorimportedinquantitiesof1tonne

11

REACH,TitleII,Arts524.

12

REACH,Art5,Art6.

JustOutofREACH


ormoreperyear.13Theregistrationdossiermust

besubmittedtotheEuropeanChemicalsAgency
(ECHA)forsubstancesmanufacturedorimported
in the EU above the 1 tonne threshold (or, for
substances in articles, that are intended for re
lease during normal usage of the article), unless
statedotherwise.14

Under this regulation, registrants are responsible for complying with data production

andtestingrequirementsundertheRegulation.Theregistrationdeadlineandinformationre
quirementsvarydependingonthehazardprofileandthequantitymanufacturedorimported.
Fourtonnagebandsactasregulatorythresholds(110tonnes,10100tonnes,1001,000ton
nes, and 1,000+ tonnes). Information requirements become progressively more extensive as
the tonnage band increases. The rationale behind this approach was the assumption that a
higher tonnage means a higher exposure, which implies higher risks posed by the substance.
Theemergenceofnanomaterialsmightchallengethisassumption.

Furthermore, REACH distinguishes the tens of thousands of chemicals already on the

marketfromnewchemicalsseekingpremarketapproval.Registrationoftheexistingchemical
inventoryisstaggeredinthreephases,withspecificdeadlinesin2010,2013,and2018.These
phaseinsubstancesincludechemicalslistedintheEuropeanInventoryofExistingCommer
cialChemicalSubstances(EINECS)priortotheentryintoforceofREACH.Irrespectiveoftheir
productionvolume,phaseinsubstancesbenefitfromdelayedregistrationdeadlinesprovided
that they were successfully preregistered by December 1, 2008.15 Preregistration required
manufacturersandimportersofchemicalsdeterminedtoqualifyforphaseinstatustosub
13

REACH,Art6,withtheexceptionofSubstancesofVeryHighConcern.

14

REACH,Art7.AlthoughforsubstancesinarticlesmeetingthecriteriainArt57andidentifiedinaccordancewith
Art59(1),aproducerorimportermustnotifytheAgencyinaccordancewithArt7(4)ifthesubstanceispresent
ingthosearticlesinquantitiestotalingover1tonneperproducer/importerperyear,andthesubstanceispresent
in,thosearticlesaboveaconcentrationof0,1%w/w.
15

REACH,Art3(20).

10

JustOutofREACH


mitinformationontheidentityofthesubstancetoECHA,includingitsEINECSnumber(ifrele
vant),tonnageband,andanyapplicableidentifiersuchasCASnumberorIUPACname.16

Full registration requirements found under Art 10 of REACH include the necessity for
manufacturersandimporterstosubmitatechnicaldossier.Theserequirementsaremeantto
gatheraminimumsetofinformationoneachsubstance.17Forsubstancesinthe10tonneston
nage band and higher, registration further requires a detailed chemical safety assessment
(CSA),18basedonmorecomprehensiveanddetaileddataontheintrinsicproperties,usesand
exposures of each substance.19 Significantly, the CSA requires the assessment of basic hazard
characteristics(e.g.,physicochemical,environmental,persistence,bioaccumulation,andtoxic
ity),and,ifindicated,anexposureassessmentandriskcharacterization.20

16

AnEINECSnumberwasassignedtoeachchemicalsubstanceundertheEuropeanInventoryofExistingCommer
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).
17

REACH,Art14(1);Art10respectively.

18

REACHArt.10,14;Withtheexceptionofsubstancesinarticlesthatarepresentinlowconcentrations.

19

R.G.Lee&S.Vaughan,REACHingDown:NanomaterialsandChemicalSafetyintheEuropeanUnion(Regulatory
GovernanceStandingGroup,RegulationintheAgeofCrisis,ConferencePaper,2010),availableathttp://
regulation.upf.edu/dublin10papers/5B3.pdf,at18.
20

REACHArt.14(3)&(4);Thelasttwostepsarenecessarywhereasubstanceisclassifiedasdangerousorfound
tobeeitheraPBTorvPvBsubstance,asperE.SpencerWilliamsetal.,TheEuropeanUnion'sREACHRegulation:A
ReviewofItsHistoryandRequirements,30CriticalRev.inToxicology553,556(2009),at561.

JustOutofREACH

11

SECTION3/ApplyingREACHprovisionstonanomaterials

REACHcontainsstrongprovisionstograduallycollectminimumdataforallsubstancesavail
ableintheEUmarketinquantitiesofmorethanonetonne.REACHprovisionsarefurthercom
plimentedbyextensiveTechnicalGuidanceDocuments(TGDs)thatspecifyhowtoimplement
the various provisions. However, because both REACH and the TGD were drafted before
nanotechnologywaswidelyused,neithertheregulationnortheguidancearefullyadaptedto
answerthequestionsraisedbythespecialpropertiesofnanomaterials.Therearefourmajor
gapsfornanomaterialsunderRegistration:(1)theidentificationofnanomaterials;(2)phasein
status;(3),tonnagethresholds;and(4)riskassessmentmethods.

3.1Identifyingnanomaterials

Thereisageneralconsensusthatnanomaterialsarenotexcludedbythesubstancedefini
tioninREACH.ButREACHprovidesonlylimitedopportunitiestoidentifythemassuch21andto
takeintoaccounttheirspecialcharacteristics.Thelimitationsinidentifyingnanomaterialsare
particularlyseverewhenabulksubstancewithasimilarchemicalcompositionexists.

Althoughtheymaybevariantsofbulksubstances,sharingthemolecularstructureorthe
same chemical composition, nanomaterials possess unique properties, which are exhibited
solelyatthenanoscale.22Typicalbulksubstanceparameterslikeaqueoussolubility,rateofdis

21

REACH,Art.3(1).

22

EuropeanCommission,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,(hereinafterCommissionFollowuptothe6thREACHCAMeeting),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.

12

JustOutofREACH


solution,dynamicsofdispersion,meltingpoint,conductivity,physicaladsorption,ormagnetic
qualitiescangreatlydifferfornanomaterials.23

ThesecondREACHImplementationProjectonNanomaterials(RIPoN2),focusedoninfor
mation required for characterising and evaluating nanomaterials, proposed a set of modifica
tionsofaTGDthatwasconsideredpoorlysuitedtonanomaterials(i.e.,withregardstoprepa
ration, exposure quantifications, measurement, dose metrics, etc.). Recommendations from
RIPoN2 address a number of domains (including physiochemical properties, toxicological,
ecotoxicologial endpoints, and more), which would require a modification of the REACH an
nexes.However,forsuchmodifications,onceadopted,tobeimplemented,nanomaterialsmust
firstbesystematicallyidentified.ThefifthversionoftheInternationalUniformChemicalInfor
mation Database (IUCLID5) system allows registrants to identify nanomaterials in registration
dossiers. REACH, however, does not explicitly define nanomaterials. Therefore, the final deci
sionindeterminingwhetherasubstanceisananomaterialrestswiththeregistrant.24

Asaresult,itisthediscretionofregistrantstoidentifysubstancesasnanomaterialsaccord
ingtotheirowncriteria.InadditiontocreatingconfusionintheimplementationofREACH,this
situationislikelytothwarteffortstouseREACHasthemainregulatorytooltogatherinforma
tion on nanomaterials on the market and to define and implement appropriate risk manage
mentmeasuresifneeded.

23

ScientificCommitteeforEmergingandNewlyIdentifiedHealthRisks,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.
24

SeeREACH,AnnexVI,Step2,statingTheregistrantshallidentifywhatinformationisrequiredfortheregistra
tion
JustOutofREACH

13

3.2Thephaseinstatusofnanomaterials

Under REACH, substances are currently identified by their chemical composition alone.
When two substances share the same chemical composition, they are considered to be the
samesubstance.Asaconsequence,ifasubstanceexistsbothinthebulkandnanoform,andif
thebulksubstanceisaphaseinsubstance,ananomaterialsharingthesamechemicalcomposi
tion will automatically benefit from the bulk versions phasein status, regardless of its new
ness.25 This can be inferred from the EINECS reporting rules and the Manual of Decisions,26
which states that, [S]ubstances in nanoform which are EINECS shall be regarded as existing
substances.27 The Commission EACH Review further stresses this point by stating that even
though potential registrants may decide that the bulk and nanoform should be registered
separatelyduringtheSIEFformationprocessduetosuchintrinsicdifferences,thenanoform
wouldstillbeallowedretainphaseinstatus.28Thisfailuretoincludeadditionalidentifiers,such
asthematerialssize,representsoneofthefundamentalgapsinREACHsabilitytoeffectively
regulatenanomaterials.

Asaconsequence,nanomaterialssharingthesamechemicalcompositionwithabulkphase
insubstancewillnotberegisteredbeforethe2013deadlineiftheyaremanufacturedorim
portedinquantitiesabove100tonnesperyearperregistrant.Nanomaterialsmanufacturedor
imported in quantities of 1100 tonnes per year per registrant will not be registered until
2018,29withtheconsequencethatthecurrent,longstandingknowledgegaponnanomaterials
willbeprolongedstillfurther.

25

Commission,Followuptothe6thREACHCAMeeting,supranote22,at78,10.
ManualofDecisionsforImplementationoftheSixthandSeventhAmendmentstoDirective67/548/EECon
DangerousSubstances,Directives79/831/EECand92/32/EECNonconfidentialversion,availableathttp://
ecb.jrc.ec.europa.eu/esis/doc/Manual_of_decisions.pdf,(hereinafterMOD).
27
MOD,supranote26,Section5.1.3,at64,asperTheAdvisoryReportfortheRipoN1process,supranote22,at
20.
28
Commission2008REACHReview,supranote1,at10(statingthatwheretwosubstancesformerlyfellunderthe
sameEINECSnumber,butwereconsideredtoodissimilartoregistertogether,bothsubstanceswouldneverthe
lessretainphaseinstatusunderREACH).
29
REACHArts23(2),(3).
26

14

JustOutofREACH


Therationaleforgrantingadelayedregistrationdeadlineforphaseinsubstancesliesinthe
practicalchallengesofregisteringandevaluatingthetensofthousandsofsubstancesalready
presentintheEUmarketbeforetheadoptionofREACH.Basedontheassumptionthatbasic
information on such substances already exists, phasein substances are not prioritized under
REACH unless warranted by specific hazardous characteristics (see Article 57). However, this
reasoning may not be relevant to nanomaterials as, even though their chemical composition
wasnotunknownatthetimeofadoption,theirphysiochemical,toxicologicalandecotoxicologi
calproperties,aswellasusesandexposurepatternsmaydiffergreatlyfromtheirbulkcounter
parts.Toxicologicalandecotoxicologicalinformationonbulksubstancesarethereforenotauto
matically transposable to the corresponding nanomaterials. A simple read across from the
bulkform,asproposedbytheEuropeanchemicalindustryfederationisnotalwayspossible.30
As a result, the availability of toxicological and ecotoxicological information on the bulk form
doesnotjustifythephaseinstatusgrantedtonanomaterials.

Thisresultsinnanomaterialsenteringandremainingonthe
market with little or no information available regarding
their potential risks, in direct contradiction with the no
data,nomarketprincipleunderlyingREACH.
Furthermore,althoughreliableinformationregardingwhichnanomaterialsarecurrentlyon
themarketisverylimited,availablestudiesshowthattheparentsubstancesofmanynano
materials(i.e.,thosewithwhichtheysharetheircorechemicalcomposition)arerelativelycom
mon31andpreexistinginbulkform.Infact,a2008study32foundthatforadatabaseofcon
sumerproductscontainingnanomaterialscurrentlyonthemarket,onlysixparentsubstances33
wereused,allwithphaseinstatus.Itfollowsthatunderthecurrentrules,thevastmajorityof

30

EuropeanChemicalIndustryCouncil(Cefic),RiskAssessmentofnanomaterialsfromanindustryperspective,
availableathttp://ec.europa.eu/health/nanotechnology/docs/ev_20110329_co12_en.pdf
31

Millieu,Risk&PolicyAnalysts(RPA),InformationfromIndustryonappliednanomaterialsandtheirsafety:Deliv
erable1,preparedforEuropeanCommissionDGEnvironment,September2009,available@http://
www.nanomaterialsconf.eu/documents/NanosTask1.pdf.
32

Hansenetal.,CategorizationFrameworktoaidExposureAssessmentofNanomaterialsinConsumerProducts,
Ecotoxicology,Vol.17No5,July2008,438447
33

Silver,Carbon(allallotropes),ZincOxide,Silica,Titaniumdioxideandgold.

JustOutofREACH

15


nanomaterialscurrentlymarketedbenefitfromphaseinstatus,delayingregistrationdeadlines.
Thisresultsinnanomaterialsenteringandremainingonthemarketwithlittleornoinformation
availableregardingtheirpotentialrisks,indirectcontradictionwiththenodata,nomarket
principleunderlyingREACH.ThisunderminestheeffectivenessandcredibilityofREACHasthe
primaryregulatorytooltobridgetheknowledgegaponnanomaterials.

3.3Tonnagethresholds

Production volumes play a significant role in determining whether and how substances
areaccountedforunderREACH.Thegeneralruleofthumbisthatthehigherthevolume,the
more data is required, and the sooner the registration.34 Regulatory thresholds are based on
fourtonnagebands(110tonnes,10100tonnes,1001,000tonnes,and1,000+tonnes).

Registrationofnanomaterialsiskeytotheirregulationsinceitallowsforthecollectionof
thenecessaryinformationfundamentaltotheapplicationofotherREACHmechanisms,suchas
restriction and authorisation. Moreover, the information provided on nanomaterials under
REACH has significance beyond REACH itself. According to the Commission, this information
will serve as input to other regulation, such as worker protection, cosmetics and environ
mentalprotection[and]complementsproductlegislation(e.g.,generalproductsafety)tothe
extentthatthisdoesnotcoverenvironmentalaspects.35

EversinceREACHwasadopted,therelevanceofREACHtonnagethresholdstonanomateri
alshasbeenquestioned.36Ineffect,therequirementforregistrationlaiddowninArticle6(1)

34

Thereareexceptionstothisprinciplesrelatingtotheregistrationofsubstancesmeetingcertaintoxicitycriteria
(i.e.:Carcinogen,Mutagen,Reprotoxic,Persistentorbioaccumulative).Thisexceptionishowevernotdeemed
relevantinthecontextofthepresentstudy,asenduringdatagapprecludethatanynanomaterialsbetheobject
ofsuchtoxicityclassificationinthenearfuture.
35

CommissionNanomaterialsRegulationReview2008,supranote1,at5.

36

Seeforexample: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

16

JustOutofREACH


ofREACHappliesonlyforproductionvolumesofonetonneormoreperyearpermanufacturer
or importer. Reliable information on the production volumes of nanomaterials is very scarce,
andhamperedbythelackofdefinitiveinventoryonthetypesandusesofnanosubstances.37
Basedontheverysmallquantitiesinwhichnanomaterialsaremarketed,38however,itseems
likely that the production and import of most nanomaterials would fall below the one tonne
thresholdrequiredforevenbasicregulationunderREACH.Itthereforemustbeassumedthat
thestandardprincipleinArticle5ofREACHNodata,nomarket"isineffectivewithrespectto
manynanomaterials.39TheGermanAdvisoryCouncilontheEnvironment(SRU)suggeststhata
coredatasetshouldstillhavetobesubmittedifananomaterialisproducedinquantitiesofless
than1tonneperyear.40

Even in the few cases in which nanomaterials are produced in volumes above the one
tonne/yearperregistrantthreshold,mostnanomaterialswillstillbenefitfromphaseinstatus
derivedfromtheirbulkcounterparts.41Consequently,theinformationsetrequiredbytheregis
trationdossierwillbelimitedtothephysicochemicalpropertiesofthesubstance,excludingany
toxicologicalandecotoxicologicalinformation,42whichmayotherwiseberequired.Norwillit
include exposure information, which is only required for substances of very high concern.43
Similarconcernsapplytotheavailabilityofinformationdownthesupplychain.44

AdetailedCSA,whichmandateshumanhealth,physicochemical,andenvironmentalhaz
ard assessment, is only mandated for substances manufactured or imported above the ten

37

R.G.Lee&S.Vaughan,supranote199,at15.

38

See,forexample,thesubstanceofmanufacturerSigmaAldrich,catalogueno.519308Carbonnanotube,sin
glewalledCarboLexAPgrade5070%purityasdeterminedbyRamanspectroscopy,tubesinbundleoflength
about20m,whichissoldinquantitiesof0.25gor1gv(pricefor1g:250.70euros),inM.Fhretal.,supra
note366,atsection5.3.2.4,6.1.2.1.
39

M.Fhretal.,surpranote36,at43,6.1.2.1.

40

GermanAdvisoryCouncilontheEnvironment(hereinafterSRU),PrecautionaryStrategiesforManaging
Nanomaterials,SummaryforPolicyMakers,Sep2011,at6.
41

Seesupra,Section2.2

42

REACH,AnnexVII.

43

REACH,Art14(3).

JustOutofREACH

17


tonne threshold/year by a single registrant.45 Because most nanomaterials are likely to pro
ducedinlowvolumes(underthe10tonnethreshold),CSAwillbeunavailableforthegreatma
jorityofnanomaterials.

3.4Riskassessmentprovisions

REACHrulesfortheprovisionofphysicochemical,toxicologicalandecotoxicologicaldata,
aswellasCSAperformancecriteriareflectmethodologiesdevelopedfortraditionalsubstances.
Severalcommentatorshavehighlightedtheneedtomodifyboththerulesandtheimplementa
tionguidelinesinordertoeffectivelyaddressthespecialrisksposedbynanomaterials.46

TheScientificCommitteeonEmergingandNewlyIdentifiedHealthRisk(SCENIHR),inpar
ticular, mentions that there areanumber of areas where the risk assessments as outlined in
REACH,andexplainedingreaterdetailintheECHA2011Guidance,47mayneedmodificationto
giveacompletepictureoftheriskspresentedbysubstancesinthenanoform.48SCENIHRob
serves, for example, that the uptake, distribution, clearance and elimination of nanoparticles
maydifferfromthoseofthechemicalsubstancesforwhichtheTGDswereinitiallydeveloped.
Itisuncertainwhetherthebasesetofstandardtestsandrecommendedproceduresareade
quate to assess effects of nanoparticles.49 Specifically, the traditional methods of measuring
45

Seearticle10ofREACH,aswellasannexesVIandVII,7.

46

SeeTheNetherlandsNationalInstituteforPublicHealthandtheEnvironment(RIVM),Exposuretonanomateri
alsinconsumerproducts,RIVMLetterReport340370001/20998,2009,at12,whichpointsoutthatthesubmis
sionofkineticinformation,whichisnecessarytoproperlyassessnanoformsubstances,isnotrequiredunder
REACH.RIVMalsocallsforREACHexposuremodelstobeadaptedtonanoformsubstancesandforits"standard
defaultassessmentfactorstobeexaminedfortheirapplicabilitytonanomaterials"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)
47

EuropeanChemicalsAgency(ECHA),GuidanceforidentificationandnamingofsubstancesunderREACHand
CLP,November2011,Version1.1(hereinafterECHA2011Guidance),availableathttp://
guidance.echa.europa.eu/docs/guidance_document/substance_id_en.pdf?time=1323858278.
48

SCENIHR2007,supranote46,at11.

49

SCENIHR2007,supranote46,at48.

18

JustOutofREACH


andevaluatingthedoseresponserelationship,relyingonmassasanindicatorofexposureand
toxicity, was found to be inappropriate by the scientific committee.50 Exposure assessments
werealsofoundtorequiremodificationstoreflectthephysicochemicalcharacteristicsofnano
materials and their potential to change throughout the substance's life cycle.51 Indeed, since
these nanomaterials may, for example, accumulate in areas with increased permeability and
crossbarrierssuchastheolfactorymucosaorthebloodbrainbarrier,52morecomplexriskas
sessmentproceduresarenecessaryfornanomaterials.53

This problem remains even under the most stringent requirements for the 1000 tonne
threshold.SCENIHRopinesthat,"[o]nthebasisofcurrentknowledge,theriskcharacterization
ofbulkmaterialsasdescribedintheTGD54cannotbedirectlyextrapolatedtonanomaterials."55
Therequiredtestingandinformationsubmissionmaynotidentifyitstruerisksduetothelimi
tationsofconventionalmethods.56Asitstands,REACHsfailuretodistinguishbetweenthebulk
and nanovariants of a substance when assessing their risks implicit[ly] (and inaccurate[ly])
[assumes]thattheriskofasubstanceisthesameatwhateverscale.57

Industryhasoftenarguedthattheabsenceofdataonthefateandeffectofnanoparticles
ontheenvironmentandhumanhealthrendersitinfeasibletoproposefirmrulesonhowsub
stances should be evaluated. By this argument, existing rules and assessment methods for

50

SCENIHR2007,supranote46,at11.

51

ibid.

52

M.Semmler,etal.2004,WG.Kreylingetal.2006,Oberdorster2004,Elder2006,asperSCENIHR2007,supra
note46,at17.
53

SCENIHR2007,supranote46,at34....thesafetyevaluationofnanoparticlesandnanostructurescannotrely
onthetoxicologicalandecotoxicologicalprofileofthebulkmaterialthathasbeenhistoricallydetermined.
54

Availableathttp://ihcp.jrc.ec.europa.eu/our_activities/healthenv/risk_assessment_of_Biocides/doc/tgd.

55

SCENIHR,supranote46at26.

56

A.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.
57

R.G.Lee&S.Vaughan,supranote199,at14.

JustOutofREACH

19


chemicals in the bulk form should remain equally applicable to nanomaterials.58 The lack of
data should not, however, justify the use of conventional rules and assessment methods. In
deed,theREACHframeworkisnotcapableofestimatingthehealthandenvironmentalrisksof
nanomaterials.59Thisisduenotonlytothetime,butalsotothecost,ofresearchtogenerate
meaningfulresults.60

Giventheselimitations,REACHinitscurrentformdoesnotequipdecisionmakersforef
fective nanoregulation because itwould lead to decisions based on hazard and exposure as
sessmentmethodsillsuitedtoproperlyassesstherisksofnanomaterials.

Indeed,theUnitedKingdomsRoyalCommissiononEnvironmentalProtection(RCEP)has
highlightedthatREACHmayactuallyhaveanindirectbutadverseeffectonriskdatageneration
fornanomaterials.61Underthecurrentregime,ifabulksubstanceischaracterizedashazard
ous, the supplier will be required to provide further information on the nature of the hazard
andthepossiblerisksinvolved.Butifthematerialisnonhazardous,asisthecaseforthevast
majority of substances from which nanomaterials are derived, this classification will be ex
tendedtothenanoformofthesubstance,withnoadditionalrequirementstogeneratedata
onspecificnanoformeffects.Fromthereon,thesubstancecouldmovethroughitsentirelife
cycle without further assessment, despite the possibility that, although it is not considered
harmfultohumanhealthortheenvironmentinitsapproveduse,itmighthavethecapacityfor
adverse impacts at some other stage, for example, as a result of release of the products of
abrasionorcombustion.62

58

EuropeanChemicalIndustryCouncil(Cefic),RiskAssessmentofnanomaterialsfromanindustryperspective,
availableathttp://ec.europa.eu/health/nanotechnology/docs/ev_20110329_co12_en.pdf
59

K.D.Grieger,A.Baun,R.Owen,supranote56,at389.

60

ibid.

61

UKRoyalCommissiononEnvironmentalPollution,NovelMaterialsintheEnvironment:Thecaseofnanotech
nology,27thReport,November2008(hereinafterRCEP).
62

RCEP,supranote61,at63,4.39.

20

JustOutofREACH

3.5Summary:Fourgapsregardingnano
withinREACH

REACH in its current form demonstrates four distinct


andsignificantgapswithregardtotheeffectiveregu
lationofnanomaterials:

Given these limitations,


REACH in its current form
does not equip decision
makers for effective nano
regulation.

1. AsREACHcurrentlystands,itisimpossibletofor
mally identify a nanomaterial with consistency
acrosstheboard. Thiscreatesconfusionandseri
ousdoubts astothecapacityofREACHtogener
atecomprehensivedataonnanomaterialscurrentlybeingmarketed.
2. SincesubstanceidentificationwithinREACHisexclusivelybasedonasubstanceschemical
composition,ananomaterialsharingthesamechemicalcompositionasanexisting(phase
in)bulksubstancewillautomaticallybenefitfromthebulkformsphaseinstatus,resulting
inadelayedregistrationdeadline.
3. Existing tonnage thresholds far exceed the quantities in which most nanomaterials enter
theEUmarket,thusgreatlylimitingtheinformationrequiredforregistrationofnanomateri
als.
4. Finally,andinadditiontotheforegoinglimitations,anyriskassessmentinformationmade
available in the context of REACH would rest on inadequate testing guidelines, very seri
ouslylimitingitspotentialutility.

IfregulatorsintendtouseREACHasthecornerstoneforaddressinghealth,safetyandenviron
mentalrisksofnanomaterials,63itisimperativethattheseshortcomingsberemedied.

63

Seesupranote5.

JustOutofREACH

21

SECTION4/Addressingthenanogaps:thelimitsofsubstance
identification

InanefforttoaddresstheseconcernsandevaluatetheapplicabilityofexistingTGD(and
ultimately of REACH) to nanomaterials, the Commission set up three REACH Implementation
ProjectsonNanomaterials(RIPoN).ThefirstoftheseRIPoNs,addressesthespecificissuesre
volving around substance identification. Having sought to develop scientific and technical ad
viceonhowtoestablishthesubstanceidentityofnanomaterials,theRIPoN1advisoryreport
highlightstheexistingdivergenceofopinionsontheadequacyofcurrentidentificationparame
ters,andpresentstwooptionsforadaptingsubstanceidentificationrulestonanomaterials:(1)
treatingnanomaterialsaswelldefinedsubstancesor(2)assubstancesofdefinedchemical
compositionandadditionalidentifiers.Yetthereportleavesunaddressedtheunderlyingques
tionsofhowtoadaptsubstanceidentityrulesunderREACHtonanomaterials.Nordoesitad
dressthematerialconsequencesthatselectingoneoranotheroftheoptionscanhaveonpo
tentialregistrationdossiersofnanomaterials.Thissectionexplorestheimpactofthesechoices
inaddressingtheinherentgapsidentifiedintheprevioussection.Asapreliminaryremark,itis
important to consider that guidance documents (including those on substance identification)
arenotbinding.Thus,ifadefinitionofnanomaterialweretobeincludedinsuchdocuments,
registrantswouldstillretainflexibilityindecidingwhethertousethisdefinitionintheirregistra
tionprocess.Modificationoftheguidancedocumentalonewouldthereforebeinsufficientto
adaptREACHtoeffectivelyregulatenanomaterials.

22

JustOutofREACH

4.1NanomaterialsasWellDefinedSubstances

4.1.1Nanomaterialsderivedfromabulkchemical

Initscurrentform,REACHsubstanceidentificationrulesarebasedonchemicalcompo

sitionalone.64Consideringnanomaterialsaswelldefinedsubstances65meansthatananomate
rialsharingthesamemolecularcompositionasachemicalinthebulkformwillbeautomati
cally assimilated to its bulk counterpart. As a consequence, other characteristics of the sub
stance,suchasitssize,willnotbeconsideredidentifiersforpurposesofsubstanceidentifica
tionunderREACH,butratherasacharacteriser.66Consequently,traditionalsubstanceiden
tityruleswillapply;requiringnotonlythatthenanoandbulkversionsberegisteredasonesub
stance, but also that the substances tonnage threshold be calculated based on the total vol
umeofsubstance(bothbulkandnanocombined)manufacturedorimportedbyeachparty.67
Thishastwomainimplications.

First,theassimilationofthenanomaterialandthebulkasonesubstanceforregistration

purposesenables,intheory,theinclusionoftheformerunderREACHregulationbecauseofthe
combinedtonnage.Inpractice,however,thismaynotbeenoughtoremedytheproblemiden
tifiedinsection3.3.ItwouldonlybringnanomaterialsintotheREACHregimeinsofarasboth
the bulk and nanomaterial are manufactured or imported by the same legal entity. In effect,
REACHtonnagethresholdsaredefinedbythevolumesapplicabletoeachpotentialregistrant.68
Incaseswherethenanomaterialismanufacturedorimportedbyadifferentlegalentitythan
theonewhomanufacturesorimportsthebulk(regardlessofwhethertheyareregardedasone
substance)tonnagethresholdswillbeconsideredindependentlyfromoneanother.

64

ECHA2011Guidance,supranote477,at14,4.1

65

ECHA2011Guidance,supranote477at144.1;at18,4.2.

66

AdvisoryReportfortheRIPoN1process,supranote22,at20,4.1.1.1

67

CommissionFollowuptothe6thREACHCAMeeting,supranote22,at6.

68

REACH,Art6,12.

JustOutofREACH

23

Second,ifnanomaterialsareconsideredeffectivelyinseparablefromthebulksubstance,

the registration requirements under REACH provide registrants with the flexibility to decide
whether ornot to include information relevant to the nanoform: There is no binding obliga
tion. The Commission opines that all relevant information on nanomaterials, covering the
properties,usesandanyrelevantclassificationandlabellingshouldbeincludedinthedossi
ers.69However,REACHdoesnotcurrentlycontainsufficientlybindingrequirementstorequire
systematicandextensiveexaminationofnanomaterialsintheregistrationdossier.Thelackof
guidanceastowhatmayconstitutesuchrelevantinformationallowsregistrantsbroaddiscre
tion.Infact,whendeterminingwhatinformationmayberelevantforpurposesofregistration
ofasubstance,AnnexVIstatesthatsimpleconsideration(asopposedtoanobligationtotake
intoaccount)ofanyinformationonexposure,useandriskmanagementmeasuresissufficient,
suggestingalenientapproachinincludingnanomaterials.

Similarlimitationsapplytotheobligationtoclassifyandlabelsubstancesinthetechni

caldossier.70TheCommissionServicesandMemberStateCompetentAuthoritieshavedecided
inthecontextofthelegislationonnew71andexistingsubstances,72thatthespecificproperties
of nanomaterials may warrant a different classification and labelling compared to the bulk
chemical,includingwhenthenanoformisderivedfromabulksubstance.73Despitethisde
termination, the Classification, Labelling and Packaging Regulation74 referred to by section 4
AnnexVIofREACHcontainsnoprovisionswhichimposesuchduties.UndertheCLP,registrants
mustidentifytherelevantinformationrelatingtotheformsandphysicalstatesinwhichthe
substanceisplacedonthemarketandinwhichitcanbereasonablyusedforpurposesofhaz

69

CommissionFollowuptothe6thREACHCAMeeting,supranote22,at6.

70

REACH,Art10(a)(iv).

71

Directive67/548/EEC,NONS)

72

Regulation(EC)793/93,ESR

73

CommissionFollowuptothe6thREACHCAMeeting,supranote22at8.

74

Regulation(EC)No1272/2008oftheEuropeanParliamentandoftheCouncilof16December2008onclassifi
cation,labelingandpackagingofsubstancesandmixtures,amendingandrepealingDirectives67/548/EECand
1999/45/EC,andamendingRegulation(EC)No1907/2006(hereinafterCLPRegulation).

24

JustOutofREACH


ard classification. However, according to the text,75 identifiable data must be readily
available,meaningthatthereisnoobligationtogeneratenewdataonagiven substance.
Consideringpresentknowledgegapsonnanomaterialsandthenewnessofthetechnologies,it
canonlybeassumedthattheavailableinformationtowhichregistrantswillrefertointhe
dossierswillrelatesolelyoratleastoverwhelminglytothebulkformofthechemical.

In addition, when actually evaluating the collected hazard information, the CLP only re
quires thatregistrants consider, rather thanmandatorily take into account, theforms, or
physicalstatesofthesubstanceinthefinalclassificationdecision.76Itfollowsthat,contrary
totheviewsofindustryexpertsaspresentedintheRipoN1advisoryreport,thereisnobind
ing obligation to include nanospecific properties such as size, in the classification of sub
stancesundertheCLPRegulation,andbyconsequenceintheregistrationdossier.77

Even the registration dossier update requirement may not adequately compensate for
informationdeficientprovisions.Therequirementtoupdatetheregistrationdossieristrig
geredwhenregistrantsareawareorreasonablyexpectedtohavebecomeawareof[changes
in] quantities manufactured or imported, new uses or new knowledge of risks to human
healthortheenvironment.78Withonlytheabilitytorelyonthe(available)toxicologicalpro
file of the bulk material, and without nanoadequate test guidelines to produce meaningful
results,itisunclearhowcompaniescaneffectivelyfulfilthisobligationandresolvethetension
betweenintentofREACHanditstext.79

75

CLPRegulation,Art5.

76

CLPRegulation,Art9.

77

theindustryexpertsarguethatsubstanceidentityisbasedonmolecularidentity,notonphysicalproperties
()Therefore,sizeascharacterizershallbeusedtodetermineappropriateclassificationundertheCLPRegula
tionaspertheAdvisoryReportfortheRIPoN1processsupranote22,at20
78

REACH,Art22.

79

S.F.Hansen,RegulationandRiskAssessmentofNanomaterials:TooLittle,TooLate?20(Feb2009)(PhDThesis,
TechnicalUniversityofDenmark),availableathttp://www.nanolawreport.com/Steffen%20Foss%20Hansen%
20PhD%20Thesis%20webversion.pdf,at20.

JustOutofREACH

25


Asaconsequence,thisapproachtowardssubstanceidentification,whichmaintainsthat
substancesofsimilarchemicalcompositionshouldberegardedasidenticalforregulatorypur
poses,isinappropriate.Thisisespeciallytrueinviewoftheprecedentsoutsidethenanomate
rialscontextinwhichotherconventionalsubstanceswithsimilarchemicalcompositionshave
beenfoundtobedifferentandthereforehavebeenidentifiedassuch.80

4.1.2Nanomaterialswithnocorrespondingbulksubstance

Inthiscase,nanomaterialswouldberegisteredintheirownright.Anumberofissues
would however remain. In particular, issues exist relating to the binding nature of the guid
ancedocument,81issuesarisingfromthephaseinstatusofmostnanomaterialscurrentlyon
themarket,82tonnagethresholds,83andtheadequacyoftestguidelinesandriskassessment
provisions.84

Thereisnobindingobligationto
includenanospecificproperties
suchassize,intheclassification
ofsubstancesundertheCLP
Regulation,andbyconsequence
intheregistrationdossier.

80

Swedishexpert,theAdvisoryReportfortheRIPoN1process,supranote22,Appendix1.

81

SeesupraintroductiontoPartIII.

82

Seesuprasection2.2

83

Seesuprasection2.3

84

Seesuprasection2.4

26

JustOutofREACH

4.2NanomaterialsasSubstancesofDefinedChemicalCompositionandAddi
tionalIdentifiers

As demonstrated above, while generally welldefined substances can be completely


identified by [their] chemical composition,85 there are other circumstances in which 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. Like welldefined
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


additionalidentifiersmeansthatthesubstancecannotbeadequatelydefinedatthenano
scalebychemicalcompositionparametersalone.Althoughamanufacturedorimportedbulk
substancewiththesamechemicalcompositionmayexist,thenanoformisrecognizedasre
quiringadditionalidentifierstobepreciselyidentified.Thisclearlysetsitapartfromthebulk
form, even though the bulk form itself may also possess additional identifiers. In concrete
terms,thiswouldpermittherecognitionofthenanosubstanceinitsownright,independent
frompreexistingbulkforms,makingdistinctregistrationspossible.

Bydesign,engineerednanomaterialsaretypicallymanufacturedfortheiruniqueproper
tiespreciselybecausesuchpropertiesdifferfromthoseofbulksubstances.Thisamplyjusti
fiesdiscriminationonthebasisofsize.88ThisanalysisissupportedbySCENIHRsopinionthat

85

ECHA2011Guidance,supranote47at14.

86

ECHA2011Guidance,supranote47at24,4.2.3.

87

SeeECHA2011Guidance,supranote47at21,table4.1foraclarificationoftheconceptofthemulti
constituentsubstance.
88

Swedishexpert,RIPoN1,supranote22Appendix1,at67.

JustOutofREACH

27


the mechanisms of toxic effects of engineered nanoparticles may be dominated by those
characteristicsspecificallyintroducedinordertomeettheintendedfunctionoftheproductof
interest(),therefore,anyunpredictedinteractionsbetweennanoparticlesandbiologicalsys
tems may depend on their unique physical and chemical properties and their multiple func
tionalities.89Byusingsizeasanidentifierratherthanacharacterizer,ananomaterialwith
thesamechemicalcompositionasabulkmaterialwouldberecognizedasauniquesubstance
thatwouldneedtoberegisteredonitsown.Thispolicydecisioncouldleadtoadifferentim
plementationofthephaseinprovisions,bynotautomaticallyextendingthebulkformsphase
instatustothenanoform.Itwouldthusprovideasolutiontothegapidentifiedinsection2.2.

However, such a policy decision would fall short of addressing the shortcomings of the
Regulationidentifiedinsection3.1,3.3and3.4.Furthermore,assubstanceidentificationrules
are defined in TGDs,90 which are nonbinding in nature, implementation of such a decision
wouldstillbewithinthediscretionofeachregistrant.

MakingREACHthecornerstoneforaddressinghealth,
safety and environmental risks in relation with nano
materials will therefore require a more substantial
modificationofthecurrentregulatoryframework.
In summary, although the decision to consider size as an identifier in the context of
REACH substance identification would potentially lead to an earlier registration, such an op
tionwouldnotfullyclosetheexistinggapsintheRegulationinrelationtonanomaterials.In
particulartheproblemsrelatedtotheexistingtonnagebandrulesandtheinadequacyofthe
traditionalriskassessmentmethodspersist.Afurtherissuerelatestothenonbindingnature
oftheTGDs.MakingREACHthecornerstoneforaddressinghealth,safetyandenvironmental
risksinrelationwithnanomaterialswillthereforerequireamoresubstantialmodificationof
thecurrentregulatoryframework.
89
90

SCENIHR,supranote23,at26.
ECHA2011Guidance,Supranote47at14,4.

28

JustOutofREACH

SECTION5/Policyrecommendations

AlthoughREACHprovidesagoodfoundationforregulatingconventionalchemicalswithin
theEU,acloserlookatitsmechanismsrevealssignificantdeficiencieswithrespecttonano
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 herein would be to
modifytheREACHregulationbyinsertingspecificprovisionsapplicabletonanomaterials:

Inordertoeffectivelysolvetheidentificationissuerelatedtosubstancesinnano
form, a definition of nanomaterial should be included in the REACH text. The
Commissionhas,afteryearsofdebate,nowputforwardarecommendationfora
nanomaterialdefinition.Thedefinitionisintendedtoprovideclearandunambi
guouscriteriatoidentifynanomaterialsforwhichitmightbenecessarytoapply
specific provisions, such as those relating to risk assessment.93 Such a definition

91

ViewthatisalsosupportedbytheEuropeanParliament,seeResolutionof24April2009onRegulatoryAspects
ofNanomaterials(2008/2208(INI)),P6_TA(2009)0328(hereinafterEUParliament2009Resolution).
92

EUParliament2009Resolution,supranote89.

93

SeeDGEnvironment,Definitionofnanomaterial,availableat:http://ec.europa.eu/environment/chemicals/
nanotech/index.htm
JustOutofREACH

29


should be included in Article 3 of REACH, next to the general substance defini
tion.

Inordertospecificallyaddressthedelaysarisingfromphaseinstatusoutlinedin
Section 3.2 of this study, Article 3(20) should further specify that nanomaterials
arenotconsideredphaseinsubstances.

Inordertoaccountforthelowproductionvolumeofmostnanomaterialsonthe
marketandensurethatacoredatasetissubmittedevenfornanomaterialspro
ducedinquantitiesoflessthan1tonneperyear,theimplementationoftonnage
triggersshouldbeadaptedtonanomaterials.Tothisend,anArticle7(4)bisshould
beintroducedwithspecifictonnagetriggersforsubstanceswithinthescopeofthe
definition of nanomaterials. This modification would, in turn, require a corre
spondingmodificationofArticle6.

Furthermore, it is necessary to modify Article 14(1) to require that registration


dossiersfornanomaterialscategoricallyincludeaCSA,inordertorespondtoexist
ingconcernsrelatingtothetoxicityofsomenanomaterialsandtheexistingknowl
edgegap,andinordertoreachthehighlevelofprotectionofhumanhealthand
theenvironment.

Finally,toadaptthetestingrequirementsandriskassessmentproceduresapplica
ble to nanomaterials, thus addressing the gap outlined in Section 3.4 while also
complying with the recommendations from SCENIHR,94 it is necessary to update
testing and risk assessment provisions and implementation guidelines to include
specificnanomaterialsprovisions.Thislastchangewouldrequiremodificationsof
AnnexesVItoXaswellasTGDs.

94

SeeSCENIHR,ModifiedOpinion(afterpublicconsultation)onTheappropriatenessofexistingmethodologiesto
assessthepotentialrisksassociatedwithengineeredandadventitiousproductsofnanotechnologies,10March
2006,availableathttp://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf
(hereinafterSCENIHR2006),at4,statingSCENIHRconcludesthatcurrentriskassessmentmethodologiesre
quiresomemodificationinordertodealwiththehazardsassociatedwithnanotechnologyandinparticularexist
ingtoxicologicalandecotoxicologicalmethodsmaynotbesufficienttoaddressalloftheissuesarisingwith
nanoparticles;SCENIHR,RiskAssessmentofProductsofNanotechnologies,19January2009,availableathttp://
ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf,at7,stating,theknowledgeand
methodologyforbothexposureestimationsandhazardidentificationneedstobefurtherdeveloped,validated,

30

JustOutofREACH


These considerations focus on the registration process. Further modifications of other
REACHprovisionsoritsannexesandTGDs(e.g.,adaptationoftheconceptofmulticonstituent
substancestoaccountforcoatednanomaterials)mightbenecessarytoadaptotherelements
oftheregulationandwouldrequirefurtheranalysis.

ConsideringthecomplexityofREACHrevisionprocesses,inparticularfortherevisionof
thecoreofthetext,anumberofstakeholders,includingtheCommission,havequestionedthe
advisabilityand/or feasibility of renegotiating REACH itself. In this context, theyrecommend
addressing the identified shortcomings of REACH, in particular in relation to nanomaterials,
throughalternativemethods.

Option2:Developingastandaloneregulation

InordertoavoidmodifyingREACHitself,whileensuringitseffectivenessinaddressingthe
uniquecharacteristicsofnanomaterials,itispossibletoaddananopatchtotheregulation
intheformofastandaloneregulation.SucharegulationwouldspecifyhowREACHtoolsand
provisions should be applied with respect to nanomaterials. To be effective, the regulation
shouldincludethefollowingbasicelements:

Apreamblethatsetsforthgeneralprinciplesforthemanagementandgovernance
ofnanomaterialsandindicatethatalltermsareusedinaccordancewiththeirdefi
nitioninREACHexceptasotherwiseexpresslyprovided;

A definition of nanomaterials (or nanosubstance to adhere to REACH termi


nology)inaccordancewiththedefinitionproposedbytheCommission;

AspecificationforhowtheREACHconceptofmulticonstituentsubstancewillbe
appliedtonanosubstances,toaddresstheissueofcoatednanomaterials;95

95

SeeforexampleETUC:ETUCconceptofaregulatorydefinitionofasubstanceinthenanoformavailableat:
http://www.etuc.org/IMG/pdf/REACH_nanosubstance_definition_ETUC_concept.pdf

JustOutofREACH

31

Arequirementthatallmanufacturersandimportersofnanomaterialsinquantities
overanappropriatetonnageshallsubmitaregistrationtoECHA(10kgisconsid
eredanappropriateprecautionarythresholdstoaccountfornanomaterialsspeci
ficities while limiting unnecessary burden), together with subsequent tonnage
thresholdstoimplementtheREACHincrementalapproach.

The specifics of the registration would be crossreferenced to the relevant section in


REACHandadaptedwherenecessary.Asanexample,suchadaptationwouldrelatetospecific
tonnagetriggers,registrationdeadlinesandotheraspectssuchastherequirementforaCSA.
Similarly, the regulation annexes would specify, via a crossreference mechanism to REACH
annexes,wheretherelevantsectionswoulddifferfornanomaterials.Specificinformationre
quirementsanddeviationfromtheoriginalREACHannexesprovisionswouldrequirefurther
refinement,whichcouldbetheobjectofasimilarsubsequentstudy.

A stand alone nano patch would provide a simple and elegant solution for adapting
REACHtothespecificitiesofnanomaterials.Itcouldfurthermorebeconceivedasflexiblein
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 the specificities of
nanomaterials.

32

JustOutofREACH

SECTION6/Conclusion

ThereisnodoubtthatREACHprovidesanincrementalapproachthatcouldbeveryuseful
in collecting much needed information regarding nanomaterials and implementing further
managementmeasures.Astheregulationcurrentlystands,however,itcontainsgapsthatren
deritcompletelyineffectivefortheregulationofnanomaterials.Thesegapsallownanomate
rials to enter the EU market with little or no information available regarding their potential
risks,indirectcontradictionwiththenodata,nomarketprinciple.

Effortstoaddresstheseissueshavebeenundertaken,butproposalsfallshortofproviding
adequatesolutions.Todate,alloftheseproposalshavefocusedonusingthenonlegallybind
ing guidance documents to address these gaps. Our analysis demonstrates that revisions to
theseguidancedocumentsalonewillbeinadequatetoaddressgapsandshortcomingspresent
intheregulationitself.WhilerenegotiatingREACHtoincludespecificprovisionsonnanotech
nologywouldbetheoreticallyfeasible,itappearspracticallyimpossible,aswellasinadvisable
inthecurrentpoliticalcontext.

Analternativesolutionbetteradaptedtothespecificcontextofnanomaterialsisavail
able in the form a stand alone nanopatch to REACH that would tailor the REACH mecha
nismstonanomaterials.Suchastandaloneregulationwouldestablishclearandlegallybind
ingprovisionsapplicabletonanomaterials,thusprovidingatransparentandcertainlegalenvi
ronmentforthesafeproductionanduseofnanomaterialsintheEUwithoutaddingcomplex
itytothealreadycomplexinstrumentthatisREACH.Thissolutionwouldhavethefurtherad
vantageofbeingmoreflexible,andwouldmakeitpossibletoadaptthelegalframeworkfor
nanomaterials more easily as our understanding grows. CIEL is looking forward to working
with all interested parties and stakeholders to develop a blue print for such a nanopatch
and fully realize REACHs potential as the regulatory cornerstone for addressing the health,
safetyandenvironmentalrisksofnanomaterials.

JustOutofREACH

33

15RuedesSavoises
1205Geneva,Switzerland
Tel:+41.22.789.0500
Fax:+41.22.789.0739
Email:geneva@ciel.org

1350ConnecticutAve.,NW,Ste.1100
Washington,DC200361739USA
Tel:+1202.785.8700
Fax:+1202.785.8701
Email:info@ciel.org

Visitusonlineatwww.ciel.org.