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7/25/2019 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

[email protected]

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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JustOutofREACH 1

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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JustOutofREACH 7

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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12 JustOutofREACH

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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JustOutofREACH 13

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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14 JustOutofREACH

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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JustOutofREACH 15

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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16 JustOutofREACH

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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JustOutofREACH 17

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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18 JustOutofREACH

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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JustOutofREACH 19

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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20 JustOutofREACH

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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22 JustOutofREACH

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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24 JustOutofREACH

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


thREACHCAMeeting,supranote22,at6.

70REACH,Art10(a)(iv).

71Directive67/548/EEC,NONS)

72Regulation(EC)793/93,ESR


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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26 JustOutofREACH

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



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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JustOutofREACH 31

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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JustOutofREACH 33

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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