t, \-/
,
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Scientific Committee on Emerging and Newly Identified Health Risks
Requestfor a scientificopinion:
on the appropriatenessof existingmethodologiesto assessthe potential risks
associatedwith engineeredand adventitiousproducts of nanotechnologies
I
LI
Background
Generalcharacteristics
ofnanotcchnologies
The tcrm "nanotcchnologies"
refersto tcchnologiesof the very small,with dimcnsionsin
thc rangeof nanomctcrs.Nanotcchnologies
cxploit the spccificpropcrticsthat arisefrom
structuringmattcr at a (meso-)scalccharacterized
by thc interplayof classicalphysics
and quantum mechanics. Today, thesc propcrtiesarc oftcn unprcdictablca priort.
Nanotcchnologicscnable other tcchnologies. Thus, thcy will mostly rcsult in the
productionof intcrmediategoods. Bccausenanotcchnologics
connectdisciplinesas
divcrsc as physics,cl-rcmistry,
gcnetics,informationand communicationtcchnologics
(ICTs),and cognitivcscicnccsamongstothers,thcy offcr thc foundationof the so-callcd
nano-bio-info-cogno
(NBIC) "convergencc".
1.2 Expcctcdbcncfitsfrom nanotcchnologics
Tcchnologyanalystshighlightnanotechnologics
as bcncfitingtoday or likely to bcncfit
in thc forcsceablcfuturc:
. matcrialsscicnccs(csp.,ccramics;morc gcncrally,lightcrand strongcrmatcrials);
. cosmctics (c.g., non-ghosting sunscrccn, nano-liposomc-bascdskin carc
products);
. housc-clcaning
products(c.g.,window-washingsprays);
r paints,vanishcs,andothcrcoatings;
. chemistry(c.g.,tailor-madccatalysts);
. informationand communication
tcchnology(c.g.,nano-clcctronics);
. biomedical applications(e.g., "lab-on-a-chip",bioscnsors,medical imaging,
prosthcses
and irnplants,drug deliverydcvices);
. cnvironmcntalrcmediationtcchnology;
. cncrgYcapturcand storagctcchnology(c.g.,solarcclls,battcrics,fucl cells,fuels
and catalysts);
. agriculturc(c.g.,sensors,
seedimprovcment);
. food (ranging from non-permcablc membrancs and, national legislation
permitting, antibacterial powdcrs to pathogcn and contaminant sensors,
cnvironmcntalmonitors,andremotcscnsingandtrackingdcvices);
. military technology.
The marketfor nanotechnologics
is cstimatedat 5700billion by 2008and morethan
I
trillion
by
2015
S
by the US NationalScienceFoundation(NSF).
1.3 Communityinterest
have led the Community to manifest
The high expectationsraisedby nanotechnologies
in its Communicationof l2 May 2004 entitled
its inteiest in boosting nanotechnologies
,.Towardsa Europearistrategyfor nanotechnology"[COM(2004) 338 final]' Council
need to develop an
cndorsed"the main messagJ-ofthis Communication,namely the
(Prcsse269), Point
integratcdand responsibles'trategy"for nanotechnologies112487104
4,p.251.
|.4
Potentialarcasfor conccm
produccd via
Some nanoparticles, nanosphercs, nanotubcs, and nanofibers
raiscconcerns
to
the-potential
includingadvcntitiousby-productshave
nanotcchnologics
and thc
workers)
of
for humanslpuutic hcalth,consumcrsafcty,and the health and safety
constitutc
nanotubcs,and nanofibcrsraisc
cnvironment.The concernsthat nanoparticles,
within the next 3-5 years' Thcy
to
nanotcchnologics
thc most significantoncs rclating
thc toxicological'
requirc furtncr studies. In this rcspect, more often than not,
risk analysisarc
complctc
a
pcrform
to
ccotoxicological,and cxposurcdata nccded
lacking.
cannotbc
Expcrt-sarc of the unanimousopinion that thc advcrsecffccts ol nanoparticles
which
sizc'
macroscopic
prcdictcd(or dcrivcrl)from thc known toxicity of matcrialof
Royal
thc
and
obcy thc laws of classicalphysics. This has lcd thc UK Royal Socicty
or
nanoparliclcs
Acudc-y of Enginccringto rccommcnd"that chemicalsin thc form of
of Ncw
nanotubcsbc trcatcd i, n"* substanccsunder thc cxisting Notification
and
Authorisation
Evaluation,
Rcgistration,
thc
(NONS) rcgulationsand in
Substanccs
p'
7l)'
l8'
Point
issucs",
"Rcgulatory
8
Rcstrictionof chcmical"s(REACH)" (Chaptcr
1.5 EuropcanCouncilrccommcndations
to intcgrating
Thc EuropcanCouncil highlightcd"thc nced to pay spccial attcntion
a'sscssmcnt
and
proccss
into thc R&D
socictal,cnvlronmcntalanJ ncattnconsidcrations
products"
112487104
of potcntialrisks throughoutthc lif-ccyclc of nanotcchnology-based
rn a
cngage
to
intention
"thc
commission's
wclcomed
and
(Prcssc269),Point o,p.zel
a framework of sharcd
dialoguc at rntcmationallcvcl, with a vicw to establishing
principlcsfbr thc
added]'
(Prcssc
269),Point8, p. 26;emphasis
ur. of nunot".hnoloE.r"112487/04
acccptable
socially
and
rcsponsible
In view of thc Coun"cil'scall for a "safe,sustainable,
a gencral
to
undcrlakc
it is thcrcforctimcly
clcvclopmcntand usc of nanotechnologics",
concem
as
rcflection on thc aclcquacyof existing risk assessmentmcthodologics
gaps
any
and thcir enginecredand adventitiousproductsand to identify
nanotcchnologies
of thcir safcty'
in currentkn&ledgc rvhich m*aybe an impedirnentto thc dcmonstration
-''1
2
Terms of reference
The scientific committee is requestedto answer the following questions,in each case,
separately:
consideringthc different kinds of nanotechnologies
1. Are existing methodologiesappropriateto assesspotentialand plausiblerisks
and processes
associated
with
associated
with differentkinds of nanotechnologies
nano-sizedmaterialsas well as the ensineercdand adventitiousoroductsof
nanotechnologies?
2. If existing methodologicsare not appropriateto assessthe hypotheticaland
potcntial risks associatcdwith certain kinds of nanotechnologies
and their
enginccrcdand adventitiousproducts,how should existing mcthodologiesbc
adaptedand/orcomplctcd?
3. In gcneralterms,what are thc major gaps in knowledgenecessaryto undcrpin
risk assessment
in thc arcasof concem?
In makingits rcport,thc Committccis askcdto includeconsidcrations
of both cngineercd
productsand potcntialrisksrelatcdto public health,to consumersafety,
and adventitious
to thc hcalthand safctvof workcrs.and to thc cnvironmcnt.
3
Deadlines
Autumn 2005(indicativcdeadlinc)
SupportingDocuments:
An occupotionulhvgiene
Aitkcn, R.J.,K.S. Crccly,and C.L. Tran (2004)Nunopurticles:
Mcdicinc (lOM) on bchalfof thc UK's
review.[A rcportof thc Institutcof Occupational
Hcalthand SafctyExccutivc(HSE)l
U RL : ht tp:/r'lvw'
r.v.hsc.qov.uki rcscarch/rrhtrru-rr274.ht nr
Amall, A U (2003)Future Tec'hnologies,
Toduv'"^Choices:Nenotechnologt,Arty'iciul
Intelligenc'eund Robotic's:A technic'ul,politicul anclinstitutionulmap of emerging
(A rcporl commissioncd
to the ImpcrialCollegeLondonby the Greenpeace
technologies.
EnvironmcntalTrust)
URL: http:/irvrvrv.grccnpcacc.org.ulc/MultimcdiaFilcsiLivc/FullRcport/5886.pdf
Inherent riskso.fdilferent
Diirrenbcrgcr,F., J. Hdck, and K. Hrjhncr (2004) Overvievv.(sec,in particular,summarytablc p. 35, rvhich proposesa
nanotechnologicalJields
and their inhcrcntrisk)
typologyof diffcrcntkinds of nanotcchnologics
URL:
http://wrvrv.temas.
chiWWWT EMAS/TEMA S:H omepage.nsfTvrvAllByKe),iOven'ieu'_T
To/,,JCdc
E'lCl Group (2003) TheBig Down
URL: http:1iwww.ctcgroup.
tslJhsBteparyq,pdf
for Health and ConsumerProtection(2004)
EuropeanCommission,Dircctorate-General
Analysis
lVtmotechnologies
: A Preliminary Risk
cu.int/comm/healtVphJislserll-rl5:I!sk-9n-.hI!1
URL : http:i/europa,
EuropeanCommission(2004) "Towards a Europeanstrategyfor nanotechnology"
338]
[coM (2004)
URL : http:/lwww.cordis.lu/nanotechnology/src/qalsmuuq4la!.htrn
EuropeanCouncil(2004)Conclusionsof the 2605'nEr.op"un CouncilMeetingon
(Presse269)]
"Competitiveness(InternalMarkct, Industryand Research)"112487104
ssDataicrVintnr/82067.pdf
Data/docs/pre
URL' http://ue.cu.int/ucDocs/crns
EuropeanParliament,Scicntific TechnoiogyOptionsAssessmcnt(2004) Nanotechnologt
web pagc
[JRL'http://www.curoparl.cu.int/stoa/talnanotcchnolosy/nanotcchnology.htm
- chancesandrisks(Band54)
Luthcr,W. (2004)Industrialapplicationof nanomaterials
Hrsg.: VDI-Tcchnologiczentrum
URL:
l0
http:/irvrvw.vdi.dc/vdi/orsanisatior/schncllauswahl/tcchno/arbcitsecbictc/zukunft/sub/
803/indcx.php
SwissRc: Nanotechnologlt
URL: httrr://rvww.srvissrc.com/INTERNIIT/rrwslvttsrrr.nsf/finBookMarkFrameSct'lReaclF
orm&BM-..ivrvAI lbylDKcyLu/FSTN-5YXLL2'lOpcnDocumcnt
und
UK Royal Socictyand thc Royal Acadcmy of Enginecring(2004) l\[ano,scienca
; opportunitie:;ttnd trncertuinties
nanotechnologies
k/fl nalRcport.htm
org.r-r
URL : http://rvrvw.nanotcc.