COMMISSION STAFF WORKING PAPER Types and uses of nanomaterials, including safety aspects Accompanying the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Second Regulatory Review on Nanomaterials
Date: 2012-10-03
Institutions: European Commission
Subjects: environmental risk prevention, labelling, nanotechnology, occupational health, packaging, safety standard, technical standard

EUROPEAN 
COMMISSION 

Brussels, 3.10.2012  
SWD(2012) 288 final 

COMMISSION STAFF WORKING PAPER 

Types and uses of nanomaterials, including safety aspects 

Accompanying the  

Communication from the Commission to the European Parliament, the Council and the 
European Economic and Social Committee 

on the Second Regulatory Review on Nanomaterials 

{COM(2012) 572 final} 

EN 

   EN 

 
 
 
  
 
COMMISSION STAFF WORKING PAPER 

Types and uses of nanomaterials, including safety aspects 

Accompanying the  

Communication from the Commission to the European Parliament, the Council and the 
European Economic and Social Committee 

on the Second Regulatory Review on Nanomaterials 

1. 

INTRODUCTION  

The  European  Parliament  in  its  resolution  of  24  April  2009  on  Regulatory  Aspects  of 
Nanomaterials1 called on the Commission to compile an inventory of nanomaterial types and 
uses. In particular, it stated: 

“H. whereas there is no clear information about the actual use of nanomaterials in consumer 
products, for instance: 

-  while  inventories  by  renowned  institutions  list  more  than  800  manufacturer-identified 
nanotechnology-based  consumer  products  currently  on  the  market,  trade  associations  of  the 
same manufacturers question these figures, on the basis that they are overestimations, without 
providing any concrete figures themselves, 

-  while  companies  happily  use  “nano-claims”,  as  the  term  “nano”  seems  to  have  a  positive 
marketing effect, they are strictly opposed to objective labelling requirements, 

J.  whereas  presentations  about  the  potential  benefits  of  nanotechnologies  predict  an  almost 
infinite  diversity  of  future  applications  of  nanomaterials,  but  fail  to  provide  reliable 
information about current uses, 

16. Calls on the Commission to compile before June 2011 an inventory of the different types 
and  uses  of  nanomaterials  on  the  European  market,  while  respecting  justified  commercial 
secrets such as recipes, and to make this inventory publicly available; furthermore calls on the 
Commission to report on the safety of these nanomaterials at the same time” 

In  its  response2  of  14  July  2009  the  Commission  stated  in  relation  to  paragraph  16  of  the 
above  resolution  that  “the  Commission  intends  to  present  information  on  types  and  uses  of 
nanomaterials,  including  safety  aspects,  in  2011.”  This  formulation  was  chosen  because  at 
the time of the resolution the implications of an “inventory” were unclear and required further 

1 

2 

http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-2009-
0328&language=EN 
Follow-up to the European Parliament resolution on regulatory aspects of nanomaterials, adopted by the 
Commission on 14 July 2009. 

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analysis, including an analysis of registration dossiers under the first registration deadline of 
the REACH Regulation3 and of notification dossiers under the CLP Regulation4. 

In its conclusions on “improving environmental policy instruments” of 20 December 20105, 
the  Council  invited  the  Commission  to  “evaluate  the  need  for  the  development  of  specific 
measures  for  nanomaterials  relating  to  risk  assessment  and  management,  information  and 
monitoring, including the further development of a harmonized database for nanomaterials, 
while considering potential impacts”. 

This  Staff  Working  Paper  intends  to  present  available  information  on  types  and  uses  of 
nanomaterials, including safety aspects and to discuss options for a harmonised database for 
nanomaterials, considering potential impacts. 

In principle, the Staff Working Paper covers nanomaterials within the scope of Commission 
Recommendation  2011/696/EU  on  the  definition  of  nanomaterial.6  Nevertheless,  as  the 
request by the European Parliament is related to nanomaterials on the market, this document 
focuses on manufactured nanomaterials, and does not cover naturally occurring nanomaterials 
(e.g.  dust,  volcanic  ash  etc.)  and  incidental  nanomaterials  (e.g.  particulate  matter  from 
combustion installations).  

The  current  EU  definition  of  nanomaterial  focuses  on  nanomaterials  with  a  majority  of 
particles in the nanoscale (1 nm to 100 nm). It is noted that particular varieties of many of the 
particulate  materials  discussed  in  this  Staff  Working  Paper  may  or  may  not  fall  under  the 
definition  in  Recommendation  2011/696/EU,  depending  on  their  specific  particle  size 
distribution. For reasons of readability, the Staff Working Paper follows the common practice 
in  using  terms  for  nanomaterials,  i.e.  when  referring  to  nano-titanium  dioxide7,  the  prefix 
“nano” is not always used, whereas it is used in other cases such as “nanosilver”. However, 
any  numbers  such  as  production  tonnages  or  market  values  always  refer  to  the  total  of  all 
nanoforms on the market, unless indicated otherwise. 

In  chapters  2  to  5,  the  Staff  Working  Paper  intends  to  give  further  explanations  on  the  EU 
definition of nanomaterial, give an overview of the main types and uses of nanomaterials on 
the  EU  market,  as  well  as  information  on  their  safety,  according  to  current  knowledge 
available  to  the  Commission,  and  an  overview  of  issues  and  activities  relating  to  risk 
assessment  of  nanomaterials.  In  principle,  such  information  can  be  presented  from  the 
perspective  of  substances  at  nanoscale,  i.e.  chemical  substances  as  defined  under  REACH 
which are nanomaterials or have forms which are nanomaterials8, enumerating their main uses 
through the supply chain and in final products, or from the perspective of finished products or 
product areas. In this document, the former approach has been chosen because the number of 
substances  at  nanoscale  is  much  more  limited  than  the  number  of  products  containing 

3 

4 

5 
6 
7 
8 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH),  OJ  L 
396, 30.12.2006, p. 1. 
Regulation  (EC)  No  1272/2008  on  classification,  labelling  and  packaging  (CLP)  of  substances  and 
mixtures, OL L 353, 31,12,2008, p.1. 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/envir/118646.pdf 
OJ L 275, 20.10.2011, p.38. 
i.e. forms of titanium dioxide with more than 50% of particles in the size range 1-100 nm. 
For 
used, 
http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/nanomaterials_en.pdf. 

terminology 

discussion 

see 

the 

of 

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nanomaterials  and  it  is  therefore  easier  to  present  the  information  in  a  structured  manner. 
Information on uses in products can be found under each substance heading. 

This document can, however, not give a complete or exhaustive picture on  all nanomaterial 
forms or variations of substances. Nanomaterials are often tailored in a very specific way to 
achieve  desired  properties.  This  may  alter  their  behaviour  as  well  as  their  toxicological  and 
ecotoxicological  properties,  throughout  their  life-cycles.  In  considering  the  safety  of 
individual  forms  or  variations,  care  should  therefore  be  taken  to  properly  take  into  account 
such  variations  in  combination  with  specific  uses  of  a  particular  form,  where  resulting  in 
different exposure scenarios. 

In chapter 6, the Staff Working Paper analyses existing databases on nanomaterials and gives 
information  on  a  planned  European  Commission  web  platform  on  nanomaterials  types  and 
uses, including safety aspects.  

2. 

DEFINITION AND TYPES OF NANOMATERIALS 

The  Commission  adopted  on  18  October  2011  Commission  Recommendation  2011/696/EU 
on  the  definition  of  Nanomaterial.9  The  Recommendation  responds  to  the  increasing  use  of 
specific  legislative  provisions  addressing  nanomaterials  and  the  need  to  ensure  harmonised 
terminology  across  different  pieces  of  legislation,  as  well  as  to  a  request  by  the  European 
Parliament.10 

The Recommendation is based on the ISO term “nanomaterial”11, a Reference Report of the 
European  Commission’s  Joint  Research  Centre  (JRC)12,  an  opinion  of  the  Scientific 
Committee  on  Emerging  and  Newly  Identified  Health  Risks  (SCENIHR)13,  on  the  195 
contributions received during public consultation14 in October – November 2010, as well as 
on  a  number  of  other  sources.  The  advice  is  presented  in  more  detail  below  in  chapters  2.2 
and 2.3. 

The core elements of the definition are laid down in articles 2 to 4: 

“2. "Nanomaterial" means a natural, incidental or manufactured material containing particles, 
in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of 
the  particles  in  the  number  size  distribution,  one  or  more  external  dimensions  is  in  the  size 
range 1 nm - 100 nm. 

In  specific  cases  and  where  warranted  by  concerns  for  the  environment,  health,  safety  or 
competitiveness  the  number  size  distribution  threshold  of  50  %  may  be  replaced  by  a 
threshold between 1 and 50 %. 

3. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes 
with one or more external dimensions below 1 nm should be considered as nanomaterials. 

9 

10 
11 
12 
13 
14 

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L 

275 

20.10.2011 

38, 
OJ 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF. 
Resolution European Parliament on Regulatory Aspects of Nanomaterials (2008/2208(INI) 24.4.2009. 
https://cdb.iso.org/cdb/termentry!display.action?entry=497556&language=1 
http://ec.europa.eu/dgs/jrc/index.cfm?id=2540 
http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_032.pdf 
http://ec.europa.eu/environment/consultations/nanomaterials.htm 

p 

http://eur-

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4.  For  the  purposes  of  point  (2),  "particle",  "agglomerate"  and  "aggregate"  are  defined  as 
follows: 

(a) "Particle" means a minute piece of matter with defined physical boundaries; 

(b)  "Agglomerate"  means  a  collection  of  weakly  bound  particles  or  aggregates  where  the 
resulting  external  surface  area  is  similar  to  the  sum  of  the  surface  areas  of  the  individual 
components; 

(c) "Aggregate" means a particle comprising of strongly bound or fused particles.” 

The purpose of the Recommendation is to ensure consistency across legislative areas as well 
as across guidance and other technical documents by the European Commission. In addition, 
the  Commission  invites  Member  States,  the  Union  agencies  and  economic  operators  to  use 
this definition, for example, in the adoption and implementation of legislation and policy and 
research programmes concerning products of nanotechnologies 

2.1. 

Application in legislation 

The definition will primarily be used in future legislation or in updates of existing legislation 
to identify materials for which special provisions (concerning for example risk assessment or 
ingredient labelling) might apply. Those special provisions are not part of the definition but of 
specific  legislation  in  which  the  definition  will  be  used.  The  Recommendation  offers  a 
common  understanding  of  the  term  “nanomaterial”  to  avoid  confusion  on  terminology  and 
inconsistency  between  different  pieces  of  legislation.  This  does  not  mean  that  specific 
legislation needs to apply to all nanomaterials, or that there could not be legislation covering 
similar materials  outside the definition. Since the definition is broad in its coverage, further 
sector  specific  qualifiers  may  be  needed  in  order  to  identify  more  precisely  those  materials 
that should potentially be subject to specific legislative requirements or policy attention.  

For  example  it  is  likely  that  in  many  cases  only  materials  that  are  a  designed  product  of  a 
deliberate manufacturing process will be of interest (commonly referred to as "engineered" or 
"manufactured" nanomaterials). Thus further qualifiers may be added on a case-by-case basis, 
in order to target the specific materials that qualify for special attention within each regulatory 
sector. 

Another consideration is that in certain specific sectors, like pharmaceuticals, it is established 
practice  to  refer  to  nanoscale  being  broader  than  1  nm  –  100  nm.  The  Recommendation 
clearly specifies that in such a situation other "nano"-terms may be needed to describe those 
products. 

2.2. 

Reference Report of the Joint Research Centre  

In June 2010 the Joint Research Centre of the European Commission released its Reference 
Report 'Considerations on a Definition of Nanomaterial for Regulatory Purposes'.15 The aim 
of  this  report  was  to  review  and  discuss  issues  and  challenges  related  to  a  definition  of 
‘nanomaterial’, and to provide practical guidance for a definition for regulatory purposes. The 
report suggests that a definition for regulatory purposes should: 

15 

G.  Lövestam  et  al.,  JRC  Reference  Report,  EUR  24403 EN,  ISBN  978-92-79-16014-1,  Luxembourg: 
Publications Office of the European Union, 2010; http://ec.europa.eu/dgs/jrc/index.cfm?id=2540. 

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• 

• 

• 

only concern particulate nanomaterials, 

be broadly applicable in EU legislation, and in line with other approaches worldwide, 

use size as the only defining property. 

2.3. 

The SCENIHR opinion 

The  Commission  also  invited  the  Scientific  Committee  on  Emerging  and  Newly  Identified 
Health Risks (SCENIHR) to provide scientific input on elements to consider when developing 
a definition of the term "nanomaterial" for regulatory purposes. The opinion "Scientific basis 
for the definition of the term 'Nanomaterial" was adopted on 8 December 2010.16 SCENIHR 
concluded that: 

• 

• 

• 

"Whereas physical and chemical properties of materials may change with size, there 
is  no  scientific  justification  for  a  single  upper  and  lower  size  limit  associated  with 
these changes that can be applied to adequately define all nanomaterials. 

There  is  scientific  evidence  that  no  single  methodology  (or  group  of  tests)  can  be 
applied to all nanomaterials. 

Size  is  universally  applicable  to  define  all  nanomaterials  and  is  the  most  suitable 
measurand. Moreover, an understanding of the size distribution of a nanomaterial is 
essential and the number size distribution is the most relevant consideration. 

In order to define an enforceable definition of “nanomaterial” for regulatory use it is proposed 
to set an upper limit for nanomaterial size and to add to the proposed limit additional guidance 
(requirements)  specific  for  the  intended  regulation.  Crucial  in  the  guidance  that  needs  to  be 
provided is the extended description of relevant criteria to characterise the nanoscale. Merely 
defining single upper and lower cut-off limits is not sufficient in view of the size distributions 
occurring in manufactured nanomaterials. 

Alternatively,  a  tiered  approach  may  be  required  depending  on  the  amount  of  information 
known for any specifically manufactured nanomaterial and its proposed use. 

The  scientific  opinion  recognises  however  that  specific  circumstances  regarding  risk 
assessment  for  regulatory  purposes  for  certain  areas  and  applications  may  require  the 
adaptation of any overarching definition. 

It  should  be  stressed  that  'nanomaterial'  is  a  categorization  of  a  material  by  the  size  of  its 
constituent  parts.  It  neither  implies  a  specific  risk,  nor  does  it  necessarily  mean  that  this 
material actually has new hazard properties compared to its constituent parts or larger sized 
counterparts." 

2.4. 

The international context 

Several  countries,  both  inside  and  outside  the  EU  have  developed  and  use  working 
definitions.  All  these  have  been  carefully  scrutinised.  There  is  variability  between  the 
different  working  definitions  but  most  of  them  are  not  as  precise  as  the  Commission 

16 

http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_032.pdf 

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Recommendation.  Most  non-EU  countries  generally  use  their  definitions  in  a  different 
regulatory  context  mainly  to  identify  individual  materials  and/or  uses,  which  then  may  be 
subject  to  specific  data  provision  or  risk  assessment  obligations.  In  the  EU,  provisions  in 
individual pieces of legislation (e.g. ingredient labelling, prior notification and authorisation 
etc.)  apply  directly  to  all  producers  of  products  containing  nanomaterials.  Therefore,  much 
more precision is required to provide legal clarity. 

Several international organisations have developed their definition of the term nanomaterial. 
Among  these,  the  definition  released  by  ISO  in  2010  (in  ISO/TS  80004-1)  was  developed 
with  the  broadest  stakeholder  base.  The  approved  definition  ('material  with  any  external 
dimension  in  the  nanoscale  (2.1)  or  having  internal  structure  or  surface  structure  in  the 
nanoscale') is fundamentally based on the term 'nanoscale' which was previously defined by 
ISO (in 2008 in ISO/TS 27687) as 'the size range from approximately 1 nm to 100 nm'. 

The ISO definition is used as a working definition for example by the OECD Working Party 
on  Manufactured  Nanomaterials  (OECD-WPMN).  Whilst  this  broad  working  definition  has 
proved useful for progressing research and development in this field, it could not be directly 
used for legal texts, for example due to the approximate nature of the term nanoscale. 

2.5. 

Essential elements of the definition 

2.5.1.  The size range 1 nm – 100 nm 

There  is  no  clear  scientific  justification  for  setting  the  thresholds  at  1 nm  and  100 nm,  as 
specific effects may also occur at a lower and higher size range. On the other hand, particles 
within  the  size  range  of  1 nm  to  100 nm  may  also  not  show  a  specific  behaviour  different 
from  the  behaviour  of  larger  particles  of  the  same  material.  Nevertheless,  many  of  the 
described specific properties of nanomaterials are actually generated by physics and chemistry 
within  that  range.17  Therefore,  in  the  absence  of  better  arguments  for  other  thresholds,  the 
Commission decided to follow the approach most commonly applied to date, i.e. a size range 
between 1 nm and 100 nm. This is in line with the advice from SCENIHR and other scientific 
bodies,  as  well  as  with  the  size  range  used  in  the  ISO  term  “nanomaterial”.  To  make  the 
definition useful for regulatory purposes, it was chosen not to retain the term 'approximately', 
which qualifies the 1 nm to 100 nm range in the ISO definition. 

2.5.2.  Aggregates and agglomerates 

To  some  extent,  agglomerated  or  aggregated  particles  may  exhibit  the  same  properties  as 
unbound particles and are therefore covered by the definition. Moreover, there can be cases 
during  the  life-cycle  of  a  nanomaterial  where  the  particles  are  released  from  weakly  bound 
agglomerates  or  under  certain  conditions  even  from  more  strongly  bound  aggregates.  The 
definition in the Recommendation therefore includes particles in agglomerates or aggregates 
whenever the constituent particles are in the size range 1 nm - 100 nm. 

2.5.3.  Based on number of particles, not mass 

The  amount  of  nanoparticles  in  a  material  can  be  determined  based  on  their  mass  fraction 
(weight of nanoparticles relative to total weight of material) or based on the particle number 
fractions  (number  of  nanoparticles  to  total  number  of  particles,  "number  size  distribution"). 

17 

J. Ramsden, The nanoscale, Nanotechnology Perceptions, Vol. 5, p. 3-25 (2008). 

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Most  measurement  methods  produce  an  intensity-weighted  size  distribution  (expressing  the 
fractions  of  particles  of  a  particular  size  as  their  relative  contribution  to  the  total  measured 
signal  intensity).  There  is  a  relation  between  these  different  size  distributions,  for  every 
material,  but  these  relations  are  not  usually  known  and  the  different  size  distributions  are 
therefore not directly convertible. 

SCENIHR argued in its opinion that "a low mass concentration of nanoparticles in a product 
may still represent a high number of particles and a mass based distribution can be skewed by 
the presence of relatively few large and thus heavy particles". As the smallest particles have a 
proportionally  higher  specific  surface  area,  which  may  be  relevant  for  toxicity  properties, 
SCENIHR considered number size distribution as a more relevant metric for possible effects 
of nanoparticles. 

The  Commission  followed  this  choice  of  metrics.  Further  work  is  certainly  needed  on  the 
metrological and standardisation aspects. Previous efforts, for example in the field of fine dust 
(PM10,  PM2.5,  etc.),  are  naturally  extending  now  into  the  nanoscale.  The  Commission  has 
already started work to provide practical guidance on particle size measurement methods18,19 
and  quality  assurance  tools  such  as  interlaboratory  studies,20,21  nanoparticle  reference 
materials22,23,24  for  particle  size  analysis  (see  also  Appendix  9  for  further  detail),  and 
characterization of complex mixtures of nanoparticles.25 

2.5.4.  A threshold in the number size distribution 

There is no unequivocal scientific basis to suggest a specific threshold in the size distribution 
below which materials containing particles in the size range 1 nm – 100 nm are not expected 
to exhibit properties specific to nanomaterials. Because of the proportionally higher specific 
surface area which may be relevant for toxicity properties exhibited by the smallest particles, 

18 

19 

20 

21 

22 

23 

24 

25 

Validation  of  dynamic  light  scattering  and  centrifugal  liquid  sedimentation  methods  for  nanoparticle 
characterisation,  A.  Braun,  O.  Couteau,  K.  Franks,  V.  Kestens,  G.  Roebben,  A.  Lamberty,  T.P.J. 
Linsinger, Advanced Powder Technology, Vol. 22, p. 766-770 (2010). 
Measurement of the size of spherical nanoparticles by means of atomic force microscopy, O. Couteau, 
G. Roebben, Measurement Science and Technology, Vol. 22, 065101 (2011). 
Interlaboratory  comparison  for  the  measurement  of  particle  size  and  zeta  potential  of  silica 
nanoparticles in an aqueous suspension, A. Lamberty, K. Franks, G. Roebben, A. Braun, V. Kestens, T. 
Linsinger,. Journal of Nanoparticle Research, Vol.13, p. 7317-7329 (2011). 
Interlaboratory  Comparison  of  Size  and  Surface  Charge  Measurements  on  Nanoparticles  prior  to 
Biological Impact Assessment, G. Roebben, S. Ramirez-Garcia, V. Hackley, M. Roesslein, F. Klaessig, 
V. Kestens, I. Lynch, M. C. Garner, A. Rawle, A. Elder, V. Colvin, W. Kreyling, H. Krug, Z. Lewicka, 
S.  McNeil,  A.  Nel,  A.  Patri,  P.  Wick,  M.  Wiesner,  Tian  Xia,  G.  Oberdörster,  K.  Dawson,  J. 
Nanoparticle Research, Vol. 13, p. 2675-2687, (DOI) 10.1007/s11051-011-0423-y (2011). 
Reference materials for measuring the size of nanoparticles, T. P. J. Linsinger, G. Roebben, C. Solans, 
R. Ramsch, Trends in Analytical Chemistry, Vol. 30, p. 18-27 (2011). 
Certification of equivalent spherical diameters of silica nanoparticles in water, ERM-FD100, A. Braun, 
K.  Franks,  V.  Kestens,  G.  Roebben,  A.  Lamberty,  T.  Linsinger,  Report  EUR  24620  EN,  European 
Union, Luxembourg, ISBN 978-92-79-18676-9, 2011. 
Nanoscale reference materials, G. Roebben, G. Reiners, H. Emons, in Nanotechnology Standards, Eds 
V.  Murashov,  J.  Howard,  Springer  Science+Business  Media,  New  York,  NY,  ISBN  –  978-1-4419-
7852-3 (2011). 
Separation and characterization of gold nanoparticle mixtures by flow-field-flow fractionation, L. 
Calzolai, D. Gilliland, C. P. Garcia, F. Rossi, J. Chromatography A, Vol. 1218, p. 4234 – 4239 (2011). 

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and  following  a  classic  scientific  approach  to  consider  three  standard  deviations,  the 
SCENIHR's advice was to use a threshold value of 0.15 %.  

The Commission decided to deviate from this threshold value based on several considerations. 
Nanoparticles  are  present  in  low  quantities  in  most  solid  materials.  The  percentage  may  be 
significant,  in  particular  in  certain  powders.  Therefore,  a  threshold  of  0.15 %  could  include 
too broad a range of materials within the definition, and would have made it difficult to tailor 
regulatory provisions appropriately. 

Nevertheless, in accordance with SCENIHR's advice, even a small number of particles in the 
range  between  1 nm  –  100 nm  may  in  certain  cases  justify  a  targeted  assessment.  For  such 
cases,  the  Recommendation  clearly  specifies  that  where  warranted  by  specific  concerns  for 
the environment, health, safety or competitiveness a threshold between 1 % and 50 % may be 
set. These threshold values will be subject to further review by 2014. 

2.5.5.  The Volume specific surface area 

It  is  possible  to  measure  a  specific  surface  area  by  mass  for  dry  solid  materials  or  powders 
with the gas adsorption method (“BET-method”). If the particle density is also known, then 
the 'volume-specific surface area' can be calculated and used as a proxy to identify a potential 
nanomaterial. For some materials, there can be a discrepancy between the measurement of the 
specific  surface  area  and  the  number  size  distribution.  The  measurement  of  the  specific 
surface area is also sensitive to the measurement method used. It is therefore specified that the 
results  for  number  size  distribution  should  prevail  and  it  should  not  be  possible  to  use  the 
specific surface area to demonstrate that a material is not a nanomaterial. 

2.5.6.  Practical use of the definition 

Guidance  and  standardised  measurement  methods  as  well  as  knowledge  about  typical 
concentrations of nanoparticles in representative sets of materials should be developed where 
feasible  and  reliable  to  facilitate  the  application  of  the  definition  in  a  specific  legislative 
context. The Commission will address these aspects as a matter of priority. However, the use 
of  the  definition  should  not  await  the  outcome  of  this  work  and  a  pragmatic  case-by-case 
approach  needs  to  be  applied  for  the  time  being.  In  fact,  this  should  be  an  iterative  process 
where  practical  experience  will  form  an  important  aspect  of  the  further  development  of 
measurement methods and standards. 

2.5.7.  Review of the definition 

Some  methodological  issues  and  questions  of  scope  could  not  be  fully  answered  in  the 
preparatory  work  for  the  definition.  Moreover  the  nanotechnology  sector  is  rapidly 
developing  and  it  is  therefore  expected  that  the  market  developments  will  require  the 
Commission Recommendation to be reviewed at certain intervals. The Recommendation will 
be reviewed by December 2014. 

In view of this review, the Commission services continue to follow up wider work on terms 
related to nanotechnology and  nanomaterials, for example by the International Organization 
for  Standardization  (ISO).  Details  about  this  work  and  its  relation  with  the  current  EU 
definition  are  presented  in  Appendix  1.  More  information  about  standardisation  work  in 
relation to nanomaterials is given in Appendix 9. 

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3. 

OVERVIEW OF NANOMATERIALS, THEIR MARKETS, USES AND BENEFITS 

Nanomaterials cover a heterogeneous range of materials. In terms of market volume the main 
categories  on  the  market  include  inorganic  non-metallic  nanomaterials  (e.g.  synthetic 
amorphous  silica,  aluminium  oxide,  titanium  dioxide),  carbon  based  nanomaterials  (e.g. 
carbon  black,  carbon  nanotubes),  metal  nanoparticles  (e.g.  nanosilver)  and  organic, 
macromolecular  or  polymeric  particulate  materials  (e.g.  dendrimers).  Nanomaterials  often 
exist  in  a  variety  of  forms  and  may  be  tailored  for  individual  properties  or  uses.  It  was  not 
possible to give market information at such a level of detail, as this information is, if at all, not 
readily available. 

In terms of industrial impact and public exposure the above-mentioned nanomaterials are of 
immediate  regulatory  relevance.  However,  there  are  also  new  types  of  nanomaterials  in 
development,  which  are  often  referred  to  as  “second  generation”  (targeted  drug  delivery 
systems,  adaptive  structures  and  actuators),  “third  generation”  (novel  robotic  devices,  three-
dimensional  networks  and  guided  assemblies),  and  “fourth  generation”  (molecule-by-molecule 
design and self-assembly capabilities) nanomaterials.26,27,28 However, those are either at research 
or  development  stage  or  at  an  early  stage  of  market  development.  Due  to  the  limited  available 
information on those materials, they are not further considered in this Staff Working Paper. 

Any estimates of the market size need to be taken with a certain degree of caution, although 
the general patterns of the estimates (i.e. order of magnitude of tonnage and market value, and 
relative size of market between the various materials) seem to be rather reliable. According to 
market  data  from  SRI  consulting  the  global  quantity  of  nanomaterials  marketed  annually  is 
around  11.5  million  tonnes,  with  a  market  value  of  roughly  20  bn  €.29  The  market  is 
dominated by two very widespread commodity materials, i.e. carbon black (9.6 million t), and 
synthethic amorphous silica (1.5 million t). Other nanomaterials with significant amounts on 
the market include aluminium oxide (200 000 t), barium titanate (15 000 t), titanium dioxide 
(10 000 t 30), cerium oxide (10 000 t), and zinc oxide (8 000 t). Carbon nanotubes and carbon 
nanofibres  are  currently  marketed  at  annual  quantities  of  several  hundreds  of  tonnes  (other 
estimates  go  up  to  a  few  thousands  of  tonnes).  Nanosilver  is  estimated  to  be  marketed  in 
annual  quantities  of  around  20  tonnes.  In  addition,  there  is  a  wide  variety  of  nanomaterials 
which  are  either  still  at  the  research  and  development  stage,  or  which  are  marketed  only  in 
small quantities, mostly for technical and biomedical applications. 

The uses of nanomaterials vary substantially, from commodity applications in everyday goods 
to highly specialised low-volume technical applications, e.g. in electronics or biomedicine. By 
far the biggest use is as a reinforcing agent for rubber in tyres and other rubber goods (global 

26 

27 

28 
29 

30 

Roco,  M.  C.  2004.  Nanoscale  Science  and  Engineering:  Unifying  and  Transforming  Tools.  AIChE 
Journal, 50(5): 890-897.  
Roco, M. C. 2007. National Nanotechnology Initiative– Past, Present, Future.” In Goddard, W. A., et al. 
eds.  Handbook  on  Nanoscience,  Engineering  and  Technology,  Boca  Raton,  FL,  CRC  Press;  pp.  3.1-
3.26.  
http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf, p. 12. 
Stefan 
Yang, 
Masahiro 
http://www.sriconsulting.com/SCUP/Public/Reports/NANOT000/;  except  for  carbon  black:  Chemical 
Economic 
black 
http://www.sriconsulting.com/CEH/Public/Reports/731.3000/; Source: IHS Inc. The use of this content 
was authorized in advance by IHS. Any further use or redistribution of this content is strictly prohibited 
a without written permission by IHS. All rights reserved.  
The Commission has also received estimates which are higher than this but still in the same rough order 
of magnitude. 

Yoneyama 

Handbook 

Suresh, 

Schlag, 

Vivien 

carbon 

report 

Bala 

and 

on 

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market  around  15  bn  €,  mainly  carbon  black),  followed  by  functional  fillers  in  polymers 
(around  1.5  bn  €,  mainly  synthetic  amorphous  silica,  in  lower  quantities  also  other  metal 
oxides and silver), various uses in electronics (1 bn €), in cosmetics (100 m €) and biomedical 
applications  (60  m  €).  In  electronics,  the  biggest  use  are  CMP31  slurries,  i.e.  fine  abrasives 
(mainly  colloidal  synthetic  amorphous  silica)  used  in  the  preparation  of  electronic 
components, followed by multi-layered ceramic capacitors (MLCC, mainly barium titanate). 
In  cosmetics,  the  main  nanomaterials  are  synthetic  amorphous  silica,  titanium  dioxide  and 
zinc  oxide.  Among  biomedical  applications,  gold  nanoparticles  in  medical  diagnostics  and 
silver nanoparticles (e.g. in hospital textiles) seem to be the biggest applications in terms of 
market value. In addition to those applications, there is use of a wide range of nanomaterials 
in paints and coatings, catalysts, solar and fuel cells, etc. 

The economic sectors with the highest use of nanomaterials32 are aerospace (e.g. lightweight 
materials,  resistant  paints  and  coatings  for  aerodynamic  surfaces);  automotive  industry  and 
transport (e.g. scratch-resistant paints and coatings, plastics, lubricants, fluids, tyres); agrifood 
(e.g.  sensors  to  optimise  food  production);  construction  (e.g.  insulation,  stronger  building 
materials,  self-cleaning  windows);  energy  generation  (e.g.  photovoltaics)  and  storage  (e.g. 
fuel cells and batteries); environment (e.g. soil and groundwater remediation); cosmetics (e.g. 
sunscreens, tooth paste, face creams); health, medicine and nanobiotechnology (e.g. targeted 
drug delivery); information and communication technologies, electronics and photonics (e.g. 
semiconductor  chips,  new  storage  devices  and  displays);  security  (e.g.  sensors  to  detect 
biological  threats);  and  textiles  (e.g.  protective  clothing,  stronger,  self-cleaning  or  fire 
resistant fibres). 

The benefits of nanomaterials are as diverse as the nanomaterials and their uses. They range 
from  saving  lives  (e.g.  targeted  cancer  drug  delivery)  to  major  technological  breakthroughs 
enabling  new  applications  or  reducing  the  environmental  impact  of  our  society  (e.g. 
photovoltaic  cells  and  batteries,  light-weight  high-strength  materials),  to  improving  the 
function  of  everyday  commodity  products  (e.g.  carbon  black  in  tyres,  synthetic  amorphous 
silica in polymers, or as food or cosmetics additive) and to improvements which are mainly of 
convenience nature (e.g. anti-odour socks).  

Nanotechnology has been identified as a key enabling technology (KET) by the High Level 
Expert  Group  (HLG)  on  Key  Enabling  Technologies.33  It  is  highly  innovative  and  provides 
the basis for further innovation and new products in a wide range of industries, as mentioned 
above.34 Products underpinned by nanotechnology are forecast to grow from a volume of 200 
bn € in 2009 to 2 trn € by 2015.35 These applications will be essential for the competitiveness 
of  a  wide  area  of  EU  products  in  the  global  market.  There  are  also  many  newly  founded 

31 
32 

33 
34 
35 

chemical mechanical planarisation 
Some of the described uses, e.g. semiconductor chips may relate to nanostructured materials rather than 
nanomaterials in the sense of the nanomaterial definition. 
http://ec.europa.eu/enterprise/sectors/ict/key_technologies/kets_high_level_group_en.htm 
For a list of effects and property improvements through nanotechnologies see appendix 4. 
According  to  Ireland’s  Nanotechnology  Commercialisation  Framework  2010  –  2014,  Forfas, 
(Aug.2010)  http://www.forfas.ie/media/forfas310810-nanotech_commercialisation_framework_2010-
2014.pdf. 

http://ec.europa.eu/enterprise/sectors/ict/key_technologies/kets_high_level_group_en.htm;  and  according 

to 
OECD, "Nanotechnology: an overview based on indicators and statistics" (2009), based on Roco, MC 
and  WS  Bainbridge,  Societal  Implications  of  Nanoscience  and  Nanotechnology,  Kluwer  Academic 
Publ, 
from 
quoted 
both 
http://ec.europa.eu/enterprise/sectors/ict/files/kets/hlg_report_final_en.pdf, p.13. 

(2001); 

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SMEs and spin-off companies in this high technology area. Currently, the direct employment 
in nanotechnology is estimated at around 300000 to 400000 jobs in the EU.36 

In many areas, nanomaterials can significantly contribute to mastering the challenges of the 
future  and  the  objectives  of  the  EU  2020  Strategy,  such  as  smart  growth,  developing  an 
economy  based  on  knowledge  and  innovation,  and  sustainable  growth,  promoting  a  low-
carbon, resource-efficient and competitive economy. They can provide essential contributions 
to  green  technologies  and  environmental  protection  (e.g.  sensors  for  smart  electricity  grids, 
filters  for  drinking  water).  They  can  also  contribute  to  inclusive  growth  by  providing  new 
employment and keeping jobs in the EU.  

It is difficult to find reliable information on the relative strength of the EU in nanotechnology 
compared to other regions of the world. The work on this document, in particular Appendix 2, 
shows  that  manufacturers  and  users  of  nanomaterials  are  spread  all  over  the  industrialised 
world.  Among  them  are  major  companies  that are located in the EU. The KET HLG report 
mentions that the EU accounts for 27% of world wide public funding on nanomaterials, 17% 
of patents37, and 15% of nano-based products.38 To an extent, this may be influenced by the 
ongoing debate in the EU on regulating nanomaterials. According to a recent survey39, half of 
the manufacturers and importers of nanomaterials in Europe replying to the survey considered 
the  regulatory  uncertainties  the  most  important  challenge  in  bringing  nanomaterials  on  the 
market.  The  emerging  economies  such  as  the  BRIC40  countries  are  still  behind  the 
industrialised  countries  in  terms  of  production  and  uptake  of  nanomaterials  but  are  quickly 
progressing.  

4. 

HEALTH AND SAFETY ASPECTS  

Health  and  safety  aspects  include  possible  intrinsic  hazard  patterns  of  the  nanomaterials, 
exposure to workers, consumers and at the waste stage, as well as applicable risk management 
measures.  Hazards  are  determined  by  the  properties  of  the  material  itself.41  However,  these 
hazards  will  only  lead  to  health  or  environmental  risks42if  parts  of  the  human  body  or  the 
environment  are  exposed  to  doses  of  the  nanomaterial  which  can  create  harmful  effects. 

36 
37 

38 

39

40 
41 

42 

Indicators 

http://ec.europa.eu/enterprise/sectors/ict/files/kets/hlg_report_final_en.pdf, p. 13. 
Source:  Cross-sectoral  Analysis  of  the  Impact  of  International  Industrial  Policy  on  Key  Enabling 
Technologies (Danish Technological Institute with IDEA Consult, 2011), Institute of Nanotechnology, 
(analysis from UNU-MERIT and VDI-TZ), 2010, OECD (2009): Nanotechnology: An Overview based 
on 
http://www.oecd.org/dataoecd/59/9/43179651.pdf, 
Statistics: 
http://www.fas.org/sgp/crs/misc/RL34511.pdf. 
This  figure  seems  in  contradiction  to  the  findings  of  appendix  2.  A  possible  explanation  is  that  the 
authors  of  the  work  at  the  basis  of  the  KET  reports  may  have  focused  on  new,  technologically 
innovative  applications  whereas  appendix  2  indicates  that  by  far  the  highest  share  of  nanomaterial 
applications  is  in  long  established  commodity  applications,  on  which  the  different  world  regions  are 
likely to have market shares similar to their share in overall economic activities. 

and 

http://www.gaia.fi/files/680/Study_on_REACH_contribution_to_emerging_technologies_Situa

tion_in_Nanotech_companies_in_Europe_DRAFT.pdf 
Brazil, Russia, China, India 
According  to  Directive  98/24/EC,  the  term  ‘hazard’  means  the  intrinsic  property  of  a  chemical  agent 
with 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:131:0011:0023:EN:PDF, Article 2(g). 
According  to  Directive  98/24/EC,  the  term  ‘hazard’  means  the  intrinsic  property  of  a  chemical  agent 
with 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:131:0011:0023:EN:PDF, Article 2(h). 

potential 

potential 

harm. 

harm. 

cause 

cause 

the 

the 

to 

to 

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12 

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Correspondingly,  risks  are  determined  by  a  combination  of  hazards  and  the  probability  of 
exposure. 

4.1. 

Hazard patterns 

The hazard patterns vary largely between different nanomaterials. In its opinion of 19 January 
200943,  the  Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks 
(SCENIHR)  concluded:  “The  health  and  environmental  hazards  were  demonstrated  for  a 
variety of manufactured nanomaterials. The identified hazards indicate potential toxic effects 
of  nanomaterials  for  man  and  environment.  However,  it  should  be  noted  that  not  all 
nanomaterials induce toxic effects. Arguably, some manufactured nanomaterials have been in 
use for a long time (carbon black, TiO2) and show low toxicity. The hypothesis that smaller 
means more reactive and thus more toxic  cannot be substantiated by the published data. In 
this  respect  nanomaterials  are  similar  to  normal  substances  in  that  some  may  be  toxic  and 
some may not. As there is not yet a generally applicable paradigm for nanomaterial hazard 
identification,  a  case  by  case  approach  for  the  risk  assessment  of  nanomaterials  is 
recommended.” 

In  their  recent  joint  report  "Impact  of  Engineered  Nanomaterials  on  Health:  Considerations 
for  Benefit-Risk  Assessment"  EASAC44  and  the  European  Commission's  Joint  Research 
Centre  conclude  that  "there  is  only  a  limited  amount  of  scientific  evidence  to  suggest  that 
nanomaterials present a risk for human health".45 

Nanomaterials may have a wide range of potential toxic effects, depending on their chemical 
nature,  particle  size  distribution,  particle  shape,  surface  state  (e.g.  surface  area,  surface 
functionalisation,  surface  treatment),  state  of  aggregation/agglomeration  etc.  Some  of  the 
main known effects from experimental studies are described below and in Appendix 2, under 
the  relevant  substance  heading.  Under  experimental  conditions,  the  most  common  effects 
observed  are  a  potential  to  cause  oxidative  stress  and,  for  some,  inflammatory  responses  or 
even genotoxic effects. 

Like for all chemicals, the potential harmful effects of nanomaterials depend on the doses to 
which  human  beings  or  the  environment  are  exposed  to.  Typically,  experimental  data  are 
generated with high doses, identifying effects, and subsequently determining no-effect levels. 
At low doses, most nanomaterials show little effects in these experiments. Views on whether 
nanomaterials  are  hazardous  or  pose  risks  diverge,  as  they  depend  crucially  on  whether  the 
experimental data are considered representative for real life conditions.46 Some consider that 
high dose experiments are a normal way of identifying hazards and their results should be an 
indication of potential risks, whereas others consider that experiments with  such high doses 
are unrealistic and that similar effects could be found at those doses even with very common, 
non-hazardous substances.  Moreover,  the route and the conditions under which test animals 
are  exposed  to  nanomaterials  is  also  critical  and  subject  to  substantial  methological 

43 
44 
45 

46 

http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf, p. 10. 
European Academies Science Advisory Council, http://www.easac.eu/home.html 
Impact  of  Engineered  Nanomaterials  on  Health:  Considerations  for  Benefit-Risk  Assessment,  Joint 
EASAC-JRC  Report,  http://ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanoreport-10-11/JRC-
EASAC-report.pdf, p. 8. 
For  a  discussion  of  these  methodological  issues,  see  e.g.  Impact  of  Engineered  Nanomaterials  on 
Report, 
Benefit-Risk  Assessment, 
Health: 
http://ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanoreport-10-11/JRC-EASAC-report.pdf,  p. 
23. 

Considerations 

EASAC-JRC 

Joint 

for 

EN 

13 

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discussions.47  There  is  however,  a  consensus  on  the  principle  that  hazards  and  risks  differ 
significantly between nanomaterials and that some are hazardous and others are not. 

For example, the joint EASAC-JRC report considers that “Overload conditions especially in 
the  lung  (macrophages)  have  been  described  for  20  years.  It  is  now  well  known  that 
overloading  the  lung  with  dust  particles  will  severely  influence  (reduce)  the  clearance 
process, thereby prolonging dramatically the biological lifetime of particles within the lung. 
Eventually,  this  leads  to  persistent  inflammatory  effects  with  all  the  characteristics  of  lung 
diseases  which  often  end  in  tumour  formation.  Therefore,  it  is  recommended  that  overload 
conditions  should  be  avoided  both  in  animal  studies  and  for  in  vitro  experiments  otherwise 
excessive doses will generate false-positive results. 

This  sense  of  realism  is  equally  warranted  for  intended  applications  where  engineered 
nanomaterials are targeted to the individual in relatively precise amounts. Moreover, testing 
genotoxicity  with  overloading  concentrations  (often  cytotoxic  concentrations)  is  also 
unrealistic  as  dying  cells  (apoptosis  as  well  as  necrosis)  cleave  their  own  DNA,  resulting 
again  in  false-positive  effects48.  If  non-overload  conditions  are  chosen,  no  carcinogenic 
effects for such dust particles are found49."50 

There  are  little  epidemiological  data,  directly evaluating  effects  of  nanomaterials  under  real 
life conditions. The few available studies, e.g. on carbon black, are considered as inconclusive 
because  of  inconsistent  epidemiological  evidence.51  Some  other  nanomaterials  such  as 
synthetic amorphous silica have been on the market for a considerable time, including in high 
exposure  conditions,  with  little,  if  any,  known  adverse  health  or  environmental  effects. 
However,  there  is  also  an  ever  growing  variety  of  new  uses  and  modified  forms,  for  which 
such  experience  does  not  exist.  Until  understanding  is  available  on  the  impacts  of  different 
forms  and  modifications  of  nanomaterials  on  the  hazard  patterns,  particular  care  should  be 
taken to avoid undue generalisation of data from one form to another. 

In  its  200652,  200753  and  200954  opinions,  the  SCENIHR  acknowledged  the  possibility  that 
translocation of nanoparticles away from the portal of entry may occur in humans and other 
species,  and  that  the  passage  of  nanoparticles  across  membranes  could  give  rise  to  adverse 
effects, for example within the cardiovascular system or following passage across the blood – 
brain barrier.  

A number of in-vivo studies in rats have demonstrated that certain nanomaterials can penetrate 
into  the  body  and  reach  certain  organs  and  tissues  (for  example  in  the  lung,  liver,  kidneys, 
heart, reproductive organs, foetus, brain, spleen, skeleton and soft tissues) via several routes 
(following  inhalation,  crossing  the  pulmonary  epithelium  and  entering  the  blood  stream;  or 
reaching  the  brain  via  the  olfactory  nerve;  or  crossing  the  intestinal  epithelium  after 

47 

48 
49 
50 

51 
52 
53 
54 

Osier  M  and  Oberdörster  G  1997,  Intratracheal  inhalation  vs  intratracheal  instillation:  differences  in 
particle effects., Fundam Appl Toxicol. 1997 Dec;40(2):220-7. 
Roller, M., Inhalation Toxicology 21, Suppl. 1, 144 (2009). 
Yokohira, M. et al., Toxicologic Pathology 36, 620 (2009). 
Impact  of  Engineered  Nanomaterials  on  Health:  Considerations  for  Benefit-Risk  Assessment,  Joint 
EASAC-JRC  Report,  http://ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanoreport-10-11/JRC-
EASAC-report.pdf, p. 23. 
http://monographs.iarc.fr/ENG/Monographs/vol93/mono93.pdf, p. 190. 
http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf 
http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_012.pdf 
http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf 

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ingestion).55,56,57,58,59,60,61,62,63,64  Moreover,  there  are  open  questions  on  bioaccumulation  of 
nanomaterials and elimination mechanisms from cells and organs. 

In animal studies, a whole series of effects have been observed under experimental conditions 
with  high  doses  (for  methodological  discussions  around  such  tests,  see  above).  The  most 
important  effects  have  been  found  in  the  lungs:  there  is  evidence  of  inflammation,  tissue 
damage, oxidative stress, chronic toxicity, cytotoxicity, fibrosis, tumours.65 Tumour formation 
was  found  in  rat  lungs  following  intraperitoneal  introduction  of  certain  nanomaterials. 
Furthermore,  in  long-term  studies  with  intratracheal  instillation  with  nanostructured  carbon 
black, aluminium oxide, aluminium silicate, titanium dioxide (hydrophilic and hydrophobic) 
and amorphous silicon dioxide, tumours were induced by all of them66,67,68,69,70. Effects like 
inflammation,  fibrosis  and  tumours  were  induced  by  several  granular  nanomaterials  in  the 
lungs  after  respiratory  exposure.  Some  nanomaterials,  including  carbon  black  and  titanium 

55 

56 

57 

58 

59 

60 

61 

62 

63 

64 

65 

66 

67 

68 

69 

70 

to 

at: 

exposure 

2009.  Available 

nanoparticles,  Luxembourg, 

EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view. 
Kreyling WG, Hirn S, Schleh C. Nanoparticles in the lungs. Nature Biotechnology 2010, 28(12):1275-
1276. 
Kreyling, W. G.; Semmler-Behnke, M.; Seitz, J.; Scymczak, W.; Wenk, A.; Mayer, P.; Takenaka, S.; 
Oberdorster,  G.,  Size  dependence  of  the  translocation  of  inhaled  iridium  and  carbon  nanoparticle 
aggregates from the lung of rats to the blood and secondary target organs. Inhalation Toxicology 2009, 
21, (S1), 55-60. 
Semmler-Behnke,  M.;  Kreyling,  W.;  Lipka,  J.;  Fertsch,  S.;  Wenk,  A.;  Takenaka,  S.;  Schmid,  G.; 
Brandau, W., Biodistribution of 1.4- and 18-nm Gold Particles in Rats. Small 2008, 4, (12), 2108-2111. 
Semmler,  M.;  Seitz,  J.;  Erbe,  F.;  Mayer,  P.;  Heyder,  J.; Oberdorster, G.;  Kreyling, W. G.,  Long-term 
clearance kinetics of inhaled ultrafine insoluble iridium particles from the rat lung, including transient 
translocation into secondary organs. Inhalation Toxicology 2004, 16, (6-7), 453-9. 
Kreyling, W. G.; Semmler, M.; Erbe, F.; Mayer, P.; Takenaka, S.; Schulz, H.; Oberdörster, G.; Ziesenis, 
A., Translocation of ultrafine insoluble iridium particles from lung epithelium to extrapulmonary organs 
is size dependent but very low. Journal of Toxicology and Environmental Health-Part A 2002, 65, (20), 
1513-1530. 
Yu,  L.  E.,  Yung,  L.-Y.  L.,  Ong,  C.-N.,  Tan,  Y.-L.,  Balasubramaniam,  K.  S.,  Hartono,  D.,  Shui,  G., 
Wenk, M. R., Ong, W.-Y., ´Translocation and effects of gold nanoparticles after inhalation exposure in 
rats´, Nanotoxicology, 1, 2007, pp. 235-242. 
AFSSET  –  Agence  Française  de  Sécurité  Sanitaire  de  l’Environnement  et  du  Travail,  Les 
at: 
nanomatériaux. 
http://www.afsset.fr/upload/bibliotheque/258113599692706655310496991596/afsset-nanomateriaux-2-
avis-rapport-annexes-vdef.pdf. 
Elder, A., Gelein, R., Silva, V., Feikert, T., Opanashuk, L., Carter, J., Potter, R., Maynard, A., Ito, Y., 
Finkelstein, J.N. & Oberdörster, G., ´Translocation of inhaled ultrafine manganese oxide particles to the 
central nervous system´, Environ Health Perspect, 114, 2006, pp. 1172-1178. 
Oberdörster, G., Sharp, Z., Atudorei, V., Elder, A., Gelein, R., Kreyling, W. & Cox, C., ´Translocation 
of inhaled ultrafine particles to the brain´, Inhalation Toxicology, 16, 2004, pp. 437-445. 
EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view. 
Mohr, U., Ernst, H., Roller, M., Pott, F., ´Pulmonary tumor types induced in Wistar rats of the socalled 
„19-dust study“´, Exp Toxicol Pathol, 58, 2006, 13-2. 
Roller,  M.,  Pott,  F.,  ´Lung  tumor  risk  estimates  from  rat  studies  with  not  specifically  toxic  granular 
dusts´, Ann. N. Y. Acad. Sci., 2006, 266-280. 
Pott, F., Roller, M., ´Lung tumours in rats after intratracheal instillation of dusts´, Ann Occup Hyg, 38, 
1994, 357-363. 
Pott,  F.,  Roller,  M.,  ´Carcinogenicity  study  with  nineteen  granular  dusts  in  rats´,  Eur.  J.  Oncol.,10, 
2005, 249-281. 
Dasenbrock,  C.,  Peters,  L.,  Creutzenberg,  O.,  Heinrich,  U.,  ´The  carcinogenic  potency  of  carbon 
particles with and without PAH after repeated intratracheal administration in the rat´, Toxicol Lett, 88, 
1996, 15-21. 

nanoparticles,  Luxembourg, 

2009.  Available 

Available 

exposure 

Sécurité 

travail, 

2008. 

at: 

au 

to 

EN 

15 

   EN 

                                                 
dioxide, were on the basis of experimental animal studies classified as “possibly carcinogen to 
humans” (group 2B) by IARC.71  

In particular, carbon nanotubes (CNTs) of length, diameter and rigidity ratios comparable to 
those of toxic forms of asbestos were shown to have a potential under experimental conditions 
to induce effects similar to those of asbestos.72 There is no clear evidence of acute effects in 
other  organs  than  lungs  but  chronic  exposure  may  lead  to  elevated  accumulation  of 
translocated  nanomaterials  eventually  leading  to  adverse  health  effects.73,74,75,76,77  In 
particular, in case of respiratory exposure to nanomaterials special attention is to be given to 
the cardio-vascular system as natural ambient particles and incidental ultrafine particles (e.g. 
welding fumes and combustion products) show some similarities (poor solubility, persistence 
in the lungs) that might indicate some common properties. 78,79,80,81,82,83 

Extensive data84 on adverse effects of particles of different sizes in ambient and indoor air can 
also  contribute  to  the  understanding  of  the  safety  aspects  of  nanomaterials  in  certain 

71  
72 

73 

74 

75 

76 

77 

78 

79 

80 

81 

82 

83 

84 

http://monographs.iarc.fr/ENG/Monographs/vol93/index.php 
Donaldson, K., Murphy, F. A., Duffin, R., Poland, C. A., 'Asbestos, carbon nanotubes and the pleural 
mesothelium:  a  review  and  the  hypothesis  regarding  the  role  of  long  fibre  retention  in  the  parietal 
pleura, inflammation and mesothelioma', Particle & Fibre Toxicology, Vol. 7, p. 5, 2010. 
Kreyling WG, Hirn S, Schleh C. Nanoparticles in the lungs. Nature Biotechnology 2010, 28(12):1275-
1276.  
Kreyling, W. G.; Semmler-Behnke, M.; Seitz, J.; Scymczak, W.; Wenk, A.; Mayer, P.; Takenaka, S.; 
Oberdorster,  G.,  Size  dependence  of  the  translocation  of  inhaled  iridium  and  carbon  nanoparticle 
aggregates from the lung of rats to the blood and secondary target organs. Inhalation Toxicology 2009, 
21, (S1), 55-60. 
Semmler-Behnke,  M.;  Kreyling,  W.;  Lipka,  J.;  Fertsch,  S.;  Wenk,  A.;  Takenaka,  S.;  Schmid,  G.; 
Brandau, W., Biodistribution of 1.4- and 18-nm Gold Particles in Rats. Small 2008, 4, (12), 2108-2111. 
Semmler,  M.;  Seitz,  J.;  Erbe,  F.;  Mayer,  P.;  Heyder,  J.; Oberdorster, G.;  Kreyling, W. G.,  Long-term 
clearance kinetics of inhaled ultrafine insoluble iridium particles from the rat lung, including transient 
translocation into secondary organs. Inhalation Toxicology 2004, 16, (6-7), 453-9. 
Kreyling, W. G.; Semmler, M.; Erbe, F.; Mayer, P.; Takenaka, S.; Schulz, H.; Oberdörster, G.; Ziesenis, 
A., Translocation of ultrafine insoluble iridium particles from lung epithelium to extrapulmonary organs 
is size dependent but very low. Journal of Toxicology and Environmental Health-Part A 2002, 65, (20), 
1513-1530. 
Kreyling WG, Hirn S, Schleh C. Nanoparticles in the lungs. Nature Biotechnology 2010, 28(12):1275-
1276. 
Kreyling, W. G.; Semmler-Behnke, M.; Seitz, J.; Scymczak, W.; Wenk, A.; Mayer, P.; Takenaka, S.; 
Oberdorster,  G.,  Size  dependence  of  the  translocation  of  inhaled  iridium  and  carbon  nanoparticle 
aggregates from the lung of rats to the blood and secondary target organs. Inhalation Toxicology 2009, 
21, (S1), 55-60. 
Semmler-Behnke,  M.;  Kreyling,  W.;  Lipka,  J.;  Fertsch,  S.;  Wenk,  A.;  Takenaka,  S.;  Schmid,  G.; 
Brandau, W., Biodistribution of 1.4- and 18-nm Gold Particles in Rats. Small 2008, 4, (12), 2108-2111. 
Semmler,  M.;  Seitz,  J.;  Erbe,  F.;  Mayer,  P.;  Heyder,  J.; Oberdorster, G.;  Kreyling, W. G.,  Long-term 
clearance kinetics of inhaled ultrafine insoluble iridium particles from the rat lung, including transient 
translocation into secondary organs. Inhalation Toxicology 2004, 16, (6-7), 453-9. 
Kreyling, W. G.; Semmler, M.; Erbe, F.; Mayer, P.; Takenaka, S.; Schulz, H.; Oberdörster, G.; Ziesenis, 
A., Translocation of ultrafine insoluble iridium particles from lung epithelium to extrapulmonary organs 
is size dependent but very low. Journal of Toxicology and Environmental Health-Part A 2002, 65, (20), 
1513-1530. 
EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view. 
Last WHO systematic review for regulatory purposes: http://www.euro.who.int/en/what-we-do/health-
topics/environment-and-health/air-quality/publications/pre2009/health-aspects-of-air-pollution-results-
Update 
from-the-who-project-systematic-review-of-health-aspects-of-air-pollution-in-europe. 
preparation in progress as part of ongoing review of Directive on ambient air quality 2008/50/EC. On 
indoor air quality see http://www.envie-iaq.eu/. 

nanoparticles,  Luxembourg, 

2009.  Available 

exposure 

at: 

to 

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16 

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circumstances,  in  particular  epidemiological  and  toxicological  studies  addressing  ultrafine 
particles.85,86,87  Ultrafine  particles  are  present  in  our  everyday  lives  and  at  various 
conventional  workplaces,  generated  by  the  applied  work  processes  (i.e.  work  processes 
generating ultrafine dust, aerosols or fumes, such as spraying, dry-cutting, polishing, material 
processing  with  laser  applications,  combustion  processes,  welding  processes  generating 
metal-welding  fumes,  etc.).88,89,90  Diesel  exhaust  exposure  and  PM10  concentrations  have 
been  related  to  higher  mortality  in  the  general  population  at  higher  pollution  rates,  and  to 
aggravation  of  asthma  and  lung  cancer  in  workers.91  Fine  particulate  matter  exposures  have 
also  been  linked  to  cardiovascular  effects.92,93  Metal  oxide  fumes,  for  example  by  welding, 
casting  and  abrasive  treatment,  may  lead  to  metal  fume  fever  and  more  severe  irreversible 
respiratory illness.94 There are continuous gaps in knowledge in relation to health effects of 
individual components of particulate matter.95 There is major ongoing research on the health 
impact  of  particulate  matter,  including  in  particular  transport-related  particles,  on  human 
health.96  A  significant  body  of  EU  environmental  regulation  including  emission  standards97 
and  workplace  codes  of  practice  or  regulations  have  been  designed  to  limit  exposure  to 
particulate matter.98 

Catalytic  effects  and  the  risk  of  fire  or  explosion  should  be  taken  into  account  in  the  risk 
assessment  of  handling  powders  consisting  of  nanomaterials  (nanopowders),  in  particular 
metal nanopowders.99 

85  

86  

87  

88 

89 

90 

91 

92 

93 

94 

95  

96 
97 
98 

99 

at 

at 

aerosols 

7/2003e). 

workplaces 

(BIA-Report 

ultrafeiner  Aerosole 

am  Arbeitsplatz,  Möhlmann  C..  Available 

Oberdörster  G,  Oberdörster  E,  Oberdörster  J.  Nanotoxicology:  an  emerging  discipline  evolving  from 
studies of ultrafine particles. Environ Health Perspect. 2005 Jul;113(7):823-39. 
Cassee  F,  Mills  N,  Newby  D:  Cardiovascular  Effects  of  Inhaled  Ultrafine  and  Nano-Sized  Particles, 
Wiley (2011). 
Hoek  G  et  al:  Concentration  Response  Functions  for  Ultrafine  Particles  and  All-Cause  Mortality  and 
Hospital  Admissions:  Results  of  a  European  Expert  Panel.  Environ.  Sci.  Technol.  2010,  44,  476–482 
Elicitation. 
Vorkommen 
http://www.dguv.de/ifa/de/pub/grl/pdf/2005_196.pdf. 
Riediger, G; Möhlmann,  C.:  Ultrafeine Aerosole  an Arbeitsplätzen  - Konventionen und  Beispiele  aus 
der Praxis. Gefahrstoffe - Reinhalt. Luft 61 (2001) Nr. 10, S. 429-434. 
Ultrafine 
http://www.dguv.de/ifa/en/pub/rep/pdf/rep04/biar0703e/bia0603e.pdf. 
Scientific  Basis  for  Swedish  Occupational  Standards  xxiv,  Arbete  och  Hälsa,  National  Institute  for 
Working Life 2003. Available at http://www.inchem.org/documents/kemi/kemi/ah2003_16.pdf.  
Fang,  S.,  Cassidy,  A.,  Christiani,  D.,  A  Systematic  Review  of  Occupational  Exposure  to  Particulate 
Matter and Cardiovascular Disease. Int J Environ Res Public Health. 2010 April; 7(4): 1773–1806.  
Morawska,  L.,  Health  Impacts  of  Ultrafine  Particles,  Australian  Government  Department  of  the 
Environment 
at 
http://www.environment.gov.au/atmosphere/airquality/publications/health-impacts/pubs/content-
chapters1-4.pdf.  
Deaths  from  pneumonia  after  welding,  Scand  J  Work  Environ  Health  2001;27(5):353  and  Kaye  P, 
Young  H,  O'Sullivan  I  (May  2002).  "Metal  fume  fever:  a  case  report  and  review  of  the  literature". 
Emerg Med J 19 (3): 268–9. 
Bell M: Assessment of the Health Impacts of Particulate Matter Characteristics; HEI Research Report 
#161 (2012). 
www.escapeproject.eu; http://www.transphorm.eu/. 
http://ec.europa.eu/environment/air/index_en.htm 
For  example  Technical  Rules  for  Hazardous  Substances  TRGS  528,  Welding  Work,  available  at 
http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/TRGS/pdf/TRGS-
528.pdf?__blob=publicationFile&v=2. 
EU-OSHA,  Workplace 
exposure 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view. 

nanoparticles,  Luxembourg, 

2009.  Available 

Available 

available 

Heritage 

2004. 

and 

at: 

at: 

to 

EN 

17 

   EN 

                                                 
There  is  a  number  of  experimental  studies  on  ecotoxicity  of  nanomaterials  which  show 
varying  results  and  a  variety  of  ecotoxic  effects.  For  example  Zhu  et  al100  report  reduced 
length  and  body  weights  of  fish  as  a  result  of  exposure  to  fullerene  aggregates.  Silver  and 
copper  nanoparticles  are  known  to  be  strongly  ecotoxic.  There  are  indications  that  this  is 
primarily related to ion release (which is relatively high compared to bigger particles due to 
the larger specific surface) rather than to the particles themselves. There are also many studies 
on  titanium  dioxide  and  zinc  oxide,  showing  diverging  results,  depending  on  the  forms  of 
nanoparticles studied.101 Unfortunately, those forms were often inadequately characterized to 
enable  the  results  from  these  studies  to  be  extrapolated  to  other  circumstances.  Overall,  the 
level  of  ecotoxicological  knowledge  is  significantly  lower  than  the  level  of  toxicological 
knowledge. There are many uncertainties relating to simulation of environmental conditions 
in  experiments  (usually  much  higher  concentration  and  more  short-term  exposure  than 
realistic  environmental  conditions,  interferences  through  solvents,  strong  dependence  on 
forms  of  nanoparticles,  surface  treatment  etc.).  There  are  also  open  questions  on 
bioaccumulation and long term exposure, even though this does not seem to be a general issue 
for all nanomaterials, as shown by the long presence of certain nanomaterials on the market, 
and the absence of observed effects for these nanomaterials. 

Although  it  is  not  always  possible  to  identify  which  information  in  REACH  registration 
dossiers relates to or covers the nanoform(s), it should be noted that most of the substances 
registered  under  REACH  which  have  nanoforms  have  not  been  classified  by  the  registrants 
for any hazard endpoint.102 

In  conclusion,  toxicological  knowledge  about  nanomaterials  is  improving  continuously. 
Despite  the  open  questions  described  above,  available  toxicological  knowledge  on 
nanomaterials suggests that many nanomaterials are non-hazardous at moderate doses while 
others are hazardous. There is a need for a more focused risk assessment of nanomaterials, on 
a  case-by-case  basis.  This  should  allow  indentifying  risks  related  to  specific  nanomaterials 
and  their  uses,  and  taking  appropriate  risk  management  measures.  In  the  absence  of  more 
detailed knowledge, there is a need to apply precautionary considerations to reduce exposure, 
in  particular  at  the  workplace.  Workplace  exposure  should  be  reduced  to  the  minimum 
applying  the  hierarchy  of  control  measures  according  to  the  workplace  legislation  such  as 
Directive 98/24/EC and specific guidance from the OECD (see 4.2). and, where these would 
not be possible because of insufficient scientific information for the necessary hazard and/or 
risk characterisation, applying the ALARA103 principle on the workplace exposure to ensure 
the safe use of nanomaterials in other ways.  

Moreover, this also does not preclude that additional precautionary action such as substance 
or use restrictions for individual substances (including on particular forms or modifications of 
nanomaterials)  may  become  necessary  if  new  information  becomes  available  indicating 
serious potential risks. Scientific work to inform the risk assessments process should continue, 
especially  regarding  nanomaterials  for  which  initial  information  suggests  possible  serious 

100 

101 

102 

103 

Zhu,  X.S.,  Zhu,  L.,  Lang  ,  Y.P.  and  Chen,  Y.S.  2008:  Oxidative  stress  and  growth  inhibition  in  the 
freshwater  fish  Carassius  auratus  induced  by  chronic  exposure  to  sublethal  fullerene  aggregates, 
Environmental Toxicology and Chemistry, vol. 27, no. 9, pp. 1979-1985. 
Reviewed  in:  Engineered  Nanoparticles  -  Review  of  Health  and  Environmental  Safety  (ENRHES), 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report; conclusions on p. 359 – 360. 
For  details,  see  appendix  2.  It  should  be  noted  that  most  (though  not  all)  of  the  registrations  for  the 
concerned substances are unspecific with respect to the nanoforms.  
As Low As Reasonably Achievable 

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hazards,  and  for  developing  a  better  understanding  of  the  role  of  different  forms  and 
modifications of nanomaterials in generating specific hazard patterns. 

4.2. 

Exposure patterns 

There  are  very  few  measured  data  on  exposure  to  nanomaterials  and  available  exposure 
models. Therefore, exposure aspects can be mainly addressed through general considerations 
and assumptions in exposure scenarios. One known important factor to characterise exposure 
is  whether  nanoparticles  occur  as  free  particles,  whether  they  occur  in  aggregates  or 
agglomerates, whether they are bound in a matrix or enclosed in equipment, or whether they 
are transformed during the production process in a way that they do not occur as nanoparticles 
in the finished product. 

Exposure is likely to be most serious if particles occur in free form, although this seems to be 
relatively  rare.  Often,  nanoparticles  aggregate  or  agglomerate  under  normal  environmental 
conditions, thereby changing (but not necessarily losing) their nanospecific properties. Studies 
are investigating whether, once inhaled and in lung fluid, such aggregates/agglomerates could 
de-aggregate/de-agglomerate  and  nanoparticles  could  be  released.104,105  There  can  be  cases 
during  the  life-cycle  of  a  nanomaterial  where  the  particles  are  released  from  weakly  bound 
agglomerates  or  under  certain,  perhaps  rather  unlikely,  conditions  even  from  more  strongly 
bound aggregates. Exposure is less likely if nanomaterials are bound in a matrix or enclosed 
in equipment. It may still occur in the long term, through environmental degradation or at the 
waste stage, or during specific operations such as abrasion or machining of the matrix. This 
may also have impacts on the environment and indirectly on humans (e.g. through drinking 
water  or  air),  though  the  evidence  is  still  very  limited  and  controversial.106,107Generally,  the 
highest risk of exposure to nanomaterials is to workers at the production stage, although this 
is  also  where  exposure  is  generally  best  controlled  with  the  use  of  closed  systems.108 
Nevertheless, risks of exposure during maintenance and cleaning of such closed systems, as 
well as in the case of leakage have to be considered. Measurements of airborne nanomaterials 
have  shown  higher  levels  where  processes  such  as  extrusion  and  cutting  of  bags  containing 
nanomaterials,  or  dry-sawing  of  nanomaterial-containing  composites  took  place.109  The  risk 

104 

105 

106  
107  

108   

109 

to 

at: 

exposure 

2009.  Available 

nanoparticles,  Luxembourg, 

Meißner, T., Potthoff, A. & Richter, V., ‘Physico-chemical characterization in the light of toxicological 
effects’, Inhalation Toxicology, 21.s1, 2009, pp. 35-39. 
EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view. 
http://www.nanex-project.eu/index.php/public-documents 
OECD-WPMN  Report  of  the  Workshop  on  Risk  Assessment  of  Manufactured  Nanomaterials  in  a 
regulatory  context,  held  on  16-18  September  2009,  in  Washington  D.C.,United  States:  No.  21  - 
ENV/JM/MONO(2010)10. 
OECD-WPMN  Guidance  on  exposure  assessment  and  mitigation:  No.  28  - ENV/JM/MONO(2010)47 
Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories; No. 
13 - ENV/JM/MONO(2009)18 Report of an OECD Workshop on Exposure Assessment and Exposure 
Mitigation: Manufactured Nanomaterials; No. 12 - ENV/JM/MONO(2009)17 Comparison of Guidance 
on  Selection  of  Skin  Protective  Equipment  and  Respirators  for  Use  in  the  Workplace:  Manufactured 
Nanomaterials; No. 11 - ENV/JM/MONO(2009)16 Emmision Assessment for Identification of Sources 
and  Release  of  Airborne  Manufactured  Nanomaterials  in  the  Workplace:  Compilation  of  Existing 
Guidance;  No.  10  - ENV/JM/MONO(2009)15  Identification,  Compilation  and  Analysis  of  Guidance 
Information for Exposure Measurement and Exposure Mitigation: Manufactured Nanomaterials; No. 8 -
 ENV/JM/MONO(2009)6 Preliminary Analysis of Exposure Measurement and Exposure Mitigation in 
Occupational Settings: Manufactured Nanomaterials. 
Möhlmann, C. et al., “Exposure to carbon nano-objects in research and industry”, INRS Occupational 
Health Research Conference 2011 “Risks associated with nanoparticles and nanomaterials”, April 2011, 

EN 

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of  chronic  exposure  of  workers  to  situations  where  such  nanomaterials-containing  products 
are processed (e.g. polishing) requires further investigation.  

Although there are very little measured data, it seems quite obvious that exposure at the use 
stage varies strongly, depending on the type of application. In technical applications where the 
nanomaterials  are  bound  in  a  matrix  (e.g.  paints  or  construction  materials)  or  embedded  in 
equipment  parts  (e.g.  in  electronics),  exposure  during  use  is  estimated  to  be  relatively  low. 
Exceptions  might  be  when  such  matrices  are  for  example  abraded  or  machined  (e.g.  dry-
sawed).110 In general, little or no information is currently available in the Safety Data Sheets 
(SDS)111,112,113,114,  making  it  often  difficult  for  employers  and  workers  at  the  use  stage  to 
assess  specific  exposure  to  nanomaterials  and  to  implement  adequate  prevention  measures. 
Relevant changes in REACH Annex II, which is the legal framework for Safety Data Sheets, 
have been made recently115, and the recent guidance from ECHA on the Safety Data Sheets 
gives further advice on how to address characteristics of nanomaterials.116 There are ongoing 
discussions whether leaching (e.g. of outdoor paints or release at the end-of-life) could lead to 
the release of significant amounts of nanoparticles. In other applications such as in food and 
cosmetics, exposure is estimated to be high due to ingestion or direct contact with the skin. In 
between  there  are  applications  such  as  tyres,  where  a  certain  degree  of  wear  and  thus 
environmental exposure occurs. 

Exposure to nanomaterials may also occur at the waste stage. Although still controversial and 
subject  to  debate,  there  are  results  from  studies  on  grinding  of  materials  consisting  of 
nanomaterials bound in a common matrix117 which do not confirm that those nanoparticles are 
released  from  the  matrix  during  grinding  (like  in  any  fine  grinding  process,  there  can  be 
release of nanoparticles but these are also formed in a similar way from the matrix in which 
the  bound  nanoparticles  are  embedded  or  from  matrices  which  do  not  contain  any 
nanomaterials at all). However, fine airborne particles containing manufactured nanoparticles 

110 

111 

112 

113 

114 

115 

116 
117 

at: 

II,  p.  64,  http://en.inrs.fr/inrs-pub/inrs01.nsf/IntranetObject-

Conference  proceedings,  Session 
accesParReference/Pdf%20EN_Nano2011_Abstracts/$File/EN_Nano2011_Abstracts.pdf. 
Möhlmann, C. et al., “Exposure to carbon nano-objects in research and industry”, INRS Occupational 
Health Research Conference 2011 “Risks associated with nanoparticles and nanomaterials”, April 2011, 
Conference proceedings, Session II, p. 64. 
Schneider,  T.,  Jansson,  A.,  Jensen,  K.  A.,  Kristjansson,  V.,  Luotamo,  M.,  Nygren,  O.,  Skaug,  V., 
Thomassen, Y., Tossavainen, A., Tuomi, T., Walllin, H., Evaluation and control of occupational health 
risks  from  nanoparticles,  TemaNord  2007:581,  Nordic  Council  of  Ministers,  Copenhagen,  2007. 
Available 
http://www.norden.org/da/publikationer/publikationer/2007-
581/at_download/publicationfile. 
Borm,  P.,  Houba,  R.,  Linker,  F., Good  uses  of  nanomaterials  in  the  Netherlands, 2008.  Available  at: 
http://www.nano4all.nl/Reporshortsummary.pdf. 
ACLI  -  Austrian  Central  Labour  Inspectorate,  Use  of  Nano  at  the  Workplace,  2009.  Available  at: 
http://www.arbeitsinspektion.gv.at/NR/rdonlyres/592E7E96-E136-453F-A87B-
3C393FC039E1/0/Nano_Untersuchung.pdf. 
SafeWork  Australia,  An  Evaluation  of  MSDS  and  Labels  associated  with  the  use  of  Engineered 
Nanomaterials. 
at 
http://safeworkaustralia.gov.au/AboutSafeWorkAustralia/Whatwedo/Publications/Pages/RP201006Eval
uationOfMSDSAndLabels.aspx. 
Commission Regulation (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 
of  the  European  Parliament  and  of  the  Council  on  the  Registration,  Evaluation,  Autorisation  and 
Restriction of Chemicals (REACH), OJ L 133, 31.5.2010, p. 1. 
http://echa.europa.eu/documents/10162/17235/sds_en.pdf 
E.g. D. Göhler, M. Stintz, L. Hillemann and M. Vorbau: Characterization of Nanoparticle Release from 
Surface Coatings by the Simulation of a Sanding Process. Ann. Occup. Hyg., Vol. 54, No. 6, pp. 615–
624, 2010. 

Available 

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could be inhaled and thus could possibly serve as a “vehicle” transporting nanomaterials into 
the  body.  Studies  are  investigating  whether,  once  in  the  body,  such  bound  nanomaterials 
could  be  released  (for  example  in  lung  fluid)  or  would  influence  the  toxicity  of  the  fine 
particles.118,119 

There  are  few  studies  on  the  environmental  fate  and  behaviour  of  nanomaterials.  This  is 
mainly  due  to  a  lack  of  methods  to  detect  nanoparticles  in  the  environment.  A  particular 
problem  is  the  distinction  between  manufactured  nanoparticles  and  incidental  or  natural 
in  airborne 
nanoparticles.  Even  under  workplace  conditions, 
nanoparticles (e.g. through diesel exhaust nanoparticles) may dominate over additions through 
emissions  from  the  manufacturing  process.  Apart  from  clear  indications  that  nanoparticles 
interact  with  natural  organic  matter,  there  is  also  little  information  about  the  fate  of 
nanoparticles in the aquatic environment. 

the  background 

level 

In  addition,  there  may  also  be  exposure  to  nanomaterials  as  a  result  of  their  presence  in 
recycled materials. While there is no information available on any identified adverse effects to 
date, the issue is starting to be considered.120,121,122 

In  conclusion,  much  more  work  on  developing  exposure  data  and  detection  methods  for 
nanomaterials in the environment is needed.  

4.3. 

Risk characterisation 

Mainly as a result of the lack of exposure data123, risk characterisation and combining hazard 
and exposure data necessarily remains at a very preliminary and qualitative level. As long as 
the considered nanomaterials are non-hazardous and do not bio-accumulate, this is a limited 
problem, as exposure to such materials is unlikely to cause toxic and ecotoxic effects, at least 
at  moderate  doses.  Where  exposure  is  unlikely  to  occur,  either  because  nanomaterials  are 
strictly contained or embedded in a matrix, or as a result of risk management measures, this 
will also be  a  limited  problem. Therefore, the focus of attention of  the regulators should be 
those  nanomaterials 
information  suggests  possible  hazards  or 
bioaccumulation  and  the  applications  of  these  nanomaterials  where  significant  exposure  of 
workers, consumers or the environment may occur.  

for  which 

initial 

According  to  current  knowledge,  examples  of  such  nanomaterials  are  the  different  forms  of 
nano-titanium  dioxide  and  nano-zinc  oxide  (due  to  high  potential  exposure,  in  particular  in 
their applications as UV-filters), carbon nanotubes (for the possible carcinogenicity of certain 
forms) and nano-silver (for possible ecotoxicity).  

118 

119 

120 

121  

122  
123  

to 

exposure 

2011)  Vorsorgestrategien 

nanoparticles,  Luxembourg, 

Meißner, T., Potthoff, A. & Richter, V., ‘Physico-chemical characterization in the light of toxicological 
effects’, Inhalation Toxicology, 21.s1, 2009, pp. 35-39. 
EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view 
Sondergutachtendes 
(Sachverständigenrat 
Sachverständigenrats 
2011 
http://www.umweltrat.de/SharedDocs/Downloads/DE/02_Sondergutachten/2011_09_SG_Vorsorgestrat
egien%20f%C3%BCr%20Nanomaterialien.pdf?__blob=publicationFile 
(Swiss Government 2008) Action Plan “Synthetic Nanomaterials” of the SwissGovernment, Bern 2008; 
http://www.bafu.admin.ch/publikationen/publikation/00574/index.html?lang=en 
OECD Working Party on Resource Productivity and Waste, Meeting 15-16 February 2012  
This  is  without  prejudice  to  many  gaps  in  hazard  data.  However,  in  this  context,  the  almost  general 
absence of exposure data makes risk characterisation systematically difficult. 

für  Nanomaterialien, 

2009.  Available 

Umweltfragen, 

Berlin 

für 

at: 

EN 

21 

   EN 

                                                 
However, priorities will need to be reviewed depending on the outcome of this work and on 
new  scientific  and  market  developments.  In  particular  in  emerging  uses,  hazard  patterns  of 
nanomaterials  may  be  different  from  studied  forms,  including  through  modification  by 
downstream  users  of  nanomaterials.  Exposure  patterns  of  nanomaterials  may  change  with 
their uptake in specific new applications. Therefore, care must be taken that those trends are 
adequately reflected in risk assessments, including exposure scenarios. 

4.4. 

Risk management 

There  is  a  variety  of  possible  risk  management  measures  to  avoid  exposure,  in  particular  at 
the workplace. Prevention of occupational risks is an employer’s responsibility according to 
Directive  89/391/EEC  on  the  introduction  of  measures  to  encourage  improvements  in  the 
safety  and  health  of  workers  at  work.124  In  situations  where  elimination  of  the  risk  or 
substitution by a substance less hazardous are not possible, the hierarchy of control measures 
as provided for by Directive 98/24/EC on the protection of the health and safety of workers 
from the risks related to chemical agents at work125 gives priority to reduction of the risk at 
source. Directive 2004/37/EC on the protection of workers from the risks related to exposure 
to  carcinogens  or  mutagens  at  work126  introduces  more  stringent  provisions  in  the  case  of 
carcinogen  or  mutagen  substances,  for  example  regarding  substitution.  These  risk 
management measures include, as also for traditional chemicals, process control (e.g. various 
degrees  of  containment,  applying  work  processes  where  nanomaterials  are  in  a  fluid  matrix 
instead  of  in  the  powder  form),  local  ventilation  and  discharge  control  measures  (e.g. 
filtration),  organisational  measures  (reducing  the  number  of  workers  exposed,  reducing  the 
exposure time, etc.) and, as last resort, personal protective equipment. The risks of exposure 
due to technical problems (damage, poor tightness) of the containment systems as well during 
maintenance  and  cleaning  operations  have  to  be  considered.  An  overview  of  relevant 
literature on workplace exposure to nanoparticles, on risk communication on nanomaterials in 
the  workplace,  as  well  as  company  Good  Practice  examples  on  the  risk  management  of 
nanomaterials127 has been compiled by the European Agency for Safety and Health at Work 
(EU-OSHA). An updated list of major information sources with regard to occupational safety 
and  health  (OSH)  and  nanomaterials,  including  examples  of  risk  assessment  tools  and 
guidance  developed  in  EU  Member  States  is  included  in  Appendix  6.  By  end  2012,  EU-
OSHA  will  make  a  web  portal  dedicated  to  OSH  and  nanomaterials  containing  information 
material for workplaces available on its website.128  

A tiered pragmatic approach to exposure measurements and assessment of nanoscale aerosols 
for workplace operations was recently developed in Germany in a dialogue between a number 

124 

125 

126 

127 

128 

L 

L 

L 

p. 

p. 

183, 

131, 

1–8; 

http://eur-

5.5.1998, 

29.6.1989, 

OJ 
lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31989
L0391&model=guichett. 
OJ 
lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31998
L0024&model=guichett. 
OJ 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:229:0023:0034:EN:PDF. 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view; 
http://osha.europa.eu/en/publications/literature_reviews/risk-perception-and-risk-communication-with-
regard-to-nanomaterials-in-the-workplace/view;  
and http://osha.europa.eu/en/practical-solutions/case-studies/index_html/practical-
solution?SearchableText=&is_search_expanded=True&getRemoteLanguage=en&keywords%3Alist=na
notechnology&nace%3Adefault=&multilingual_thesaurus%3Adefault=&submit=Search 
http://osha.europa.eu 

29.6.2004, 

http://eur-

http://eur-

11–23; 

p.23; 

229, 

EN 

22 

   EN 

                                                 
of  institutions.129  The  approach  combines  established  risk  management  concepts  with 
elements of exposure assessment according to the current technology, and it is based on the 
experience of the participating practitioners.  

In order to better understand and improve the knowledge base on protection of workers from 
possible risks arising from exposure to and use of nanomaterials and/or nanotechnology in the 
workplace, the Commission has launched a study130 aiming to: (i) check the extent to which 
the current EU OSH legal framework covers sufficiently and effectively nano-related risks in 
the workplace; (ii) delineate a series of possible scenarios that should help shed light on which 
options may be better suited to tackling nano-related workplace risks without undue demands 
on businesses; and (iii) the drafting of a practical guidance document that may help tackle the 
mentioned  workplace  risks  in  waiting  for  a  developed  regulatory  framework  to  be  put  in 
place. To achieve this, the study will include an in-depth characterisation of likely exposures 
of workers to nanomaterials, relevant risk assessment issues, types  and effectiveness  of  risk 
management measures and relevant regulatory issues. The study is scheduled to be finalised 
by  early  2013.  The  Commission  will  also  give  consideration  to  requesting  a  more  robust 
involvement of the EU-OSHA with a view to raise awareness and/or disseminate information, 
as appropriate, in relation to any possible risks posed by nanomaterials and/or nanotechnology 
in EU workplaces. 

Awaiting the outcome of this study, new approaches aiming to control workers exposure have 
recently  been  presented.  An  example  is  the  so-called  Nano  Reference  Values  (NRVs) 
system131  proposed  as  provisional  alternatives  for  HBR-OELs132  or  DNELs133  or  US-
NIOSH’s approach in recommending an OEL for TiO2 nanoparticles.134 This system is based 
on a precautionary, thus not on a risk-based approach. While not guaranteeing that exposures 
below the NRV-level are safe, NRVs define a maximum generic level for the concentration of 
nanoparticles 
the  background  particle 
concentration.  NRVs  are  intended  to  be  a  warning  level  to  urge  for  risk  management  of 
nanoparticles  at  the  workplace.  According  to  this  approach,  when  exceeding  this  level  of 
exposure,  reducing  measures  should  be  taken.  In  any  event  such  measures  should  also  be 
considered for exposures below the NRVs.  

the  workplace  atmosphere,  corrected  for 

in 

Exposure  to  consumers  and  the  environment  at  the  use  stage,  and  to  an  extent  also  at  the 
waste  stage  is  more  difficult  and  often  impossible  to  control  through  risk  management 
measures  at  the  place  of  exposure.  There  are  in  principle  many  tools  to  manage  risks  for 
consumers  and  the  environment  at  the  place  of  exposure  such  as  proper  use  instructions, 
disposal or recycling of products.135 Nevertheless, as they are not always effective, the most 

129 
130 

131 

132 
133 
134  

135 

https://www.vci.de/Downloads/Tiered-Approach.pdf 
Study  service  contract  to  establish  the  potential  impact  of  Nanomaterials  &  Nanotechnology  at  the 
Workplace,  evaluate  the  scope  and  requirements  of  possible  modifications  of  relevant  EU  Safety  & 
Health  at  Work  legislation  and  elaborate  a  guidance  document  to  accommodate  corresponding 
risks/concerns, with a view to ultimately ensure adequate protection of workers health and safety from 
risks inherent to exposure to Nanomaterials and/or Nanotechnology use. 
As currently developed and tested under the auspices of the IVAM University of Amsterdam, the Dutch 
Trade Unions and Dutch Employers Organization. 
health-based recommended occupational exposure limit 
derived no-effect level 
NIOSH  Occupational  Exposure  to  Titanium  Dioxide,  Current  Intelligence  Bulletin  63,  2011  (  
http://www.cdc.gov/niosh/docs/2011-160/  )  with  NIOSH’s  OEL  recommendation  of    0.3  mg/m3  for 
nanoparticles of TiO2 (versus 2.4 mg/m3 for fine particles>100nm). 
See http://ec.europa.eu/environment/index_en.htm 

EN 

23 

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realistic  and  promising  approach  to  control  exposure  to  consumers  and  the  environment, 
where needed, remains the reduction of emissions at source. 

In  conclusion,  where  risks  are  identified,  appropriate  risk  management  measures  need  to  be 
taken.  This  includes  a  range  of  possible  measures  to  control  exposure  at  the  workplace  or 
minimize exposure to consumers and the environment through risk management measures at 
source, and to the extent possible through measures such as proper use instructions, disposal 
or recycling of products. Where the application of current regulatory obligations such as from 
REACH  registration  or  the  Chemical  Agents  Directive  may  not  be  sufficiently  effective, 
further regulatory action, including possible restrictions of use of certain nanomaterials may 
become necessary.  

5. 

RISK ASSESSMENT  

5.1. 

The opinions of the EU risk assessment bodies 

In  light  of  the  benefits  derived  from  applications  of  the  nanotechnologies  and  resulting, 
expected  growth  of  their  presence  on  the  EU  market,  following  an  initial  mapping  of  the 
potential  risks  of  nanotechnologies  in  March  2004136,  the  European  Commission  asked, 
respectively,  the  three  non-food  Scientific  Committees  (Scientific  Committee  on  Emerging 
and  Newly  Identified  Health  Risks  (SCENIHR),  Scientific  Committee  on  Consumer  Safety 
(SCCS),  Scientific  Committee  on  Health  and  Environmental  Risks  (SCHER))137,  the 
European Food Safety Authority (EFSA)138, the European Medicines Agency (EMA)139, and 
the European Chemicals Agency (ECHA)140 to address the safety of nanomaterials. 

SCENIHR  concluded  that  “while  risk  assessment  methodologies  for  the  evaluation  of 
potential  risks  of  substances  and  conventional  materials  to  man  and  the  environment  are 
widely  used  and  are  generally  applicable  to  nanomaterials,  specific  aspects  related  to 
nanomaterials  still  require  further  development.  This  will  remain  so  until  there  is  sufficient 
scientific  information  available  to  characterise  the  harmful  effects  of  nanomaterials  on 
humans and the environment.”141 

The guidance provided by EFSA (2011)142 offers a strategy for risk assessment in food and 
feed.  It  concerns  (i)  characterisation  requirements  of  engineered  nanomaterials  used  in  food 
and  feed  and  (ii)  testing  approaches  to  identify  and  characterise  hazards  to  human  health 
during use. The guidance lowers information requirements in the absence of exposure, i.e., no 
migration from a food contact material, or of absorption of engineered nanomaterials as such 
because of complete degradation/dissolution. The guidance also flags uncertainties. 

136 
137 
138 
139 
140 
141 

142 

http://ec.europa.eu/health/ph_risk/documents/ev_20040301_en.pdf 
http://ec.europa.eu/health/scientific_committees/policy/index_en.htm 
http://www.efsa.europa.eu/ 
http://www.ema.europa.eu/ 
http://echa.europa.eu/home_en.asp 
Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks  (SCENIHR)  Opinion  on:  Risk 
Assessment  of  Products  of  nanotechnologies.  Adopted  by  the  SCENIHR  during  the  28th  plenary 
meeting 
2009. 
19 
(http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf), p. 52. 
Guidance of Scientific Committee: Guidance on the risk assessment of the application of nanoscience 
and  nanotechnologies  in  the  food  and  feed  chain.  EFSA  Journal  2011;9(5):2140  [36  pp.]. 
doi:10.2903/j.efsa.2011.2140 (http://www.efsa.europa.eu/en/efsajournal/pub/2140.htm) 

January 

of 

EN 

24 

   EN 

                                                 
In the food area, EFSA assessed the safety of silver hydrosol143 and titanium nitride144 for use 
as  food  contact  materials.  Titanium  nitride, silicon  dioxide (synthetic amorphous silica) and 
carbon black are authorised with specifications as food contact materials.145 

In the medicinal products area, EMA has been examining applications of nanotechnologies to 
medicinal  products  since  2006.146  To  date,  recommendations  from  the  EMA  Committee  for 
Medicinal  Products  for  Human  Use  (CHMP)  has  led  to  the  approval  of  about  twenty 
medicines  based  on  nanotechnology.  They 
liposomes 
(microscopic  fatty  structures)  containing  active  substances,  such  as  doxorubicin147; 
mifamurtide148  and  doxorubicin149  and  nanoscale  particles  of  active  substances,  such  as 
paclitaxel150, aprepitant151 and sirolimus152.153 

include  medicines  containing 

Marketed  medical  devices  using  nanotechnologies  concern  a  broad  range  of  medical 
applications,  ranging  from  traditional  medical  equipment  to  sophisticated  electronic 
biomimetic  devices  via  orthopaedic,  dental  or  cardiovascular  implants  and  novel  treatments 
against cancer. A report published by the French Health Products Agency (AFSSAPS) on 18 
August  2011  lists  17  products  in  the  EU  alone.154  Some  national  authorities  in  the  EU 
Member  States  have  developed  specific  guidance.  The  European  Commission  envisages 
addressing  the  issue  of  nanomaterials  in  the  context  of  the  revision  of  the  medical  device 
legislation planned for 2012. 

In the cosmetics area, the European Commission mandated the SCCS to develop guidance on 
nanomaterial  risk  assessment,  including  criteria  for  their  categorisation155  and  assess  four 

143 
144 
145 
146 

147

148

149

150

151

152

153

154

The assessment of silver hydrosol was inconclusive as insufficient data were provided. 
http://www.efsa.europa.eu/en/efsajournal/pub/888.htm 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF 
EMA  Reflection  paper  on  nanotechnology-based  medicinal  products  for  human  use  (29/06/2006) 
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000345.j
sp&mid=WC0b01ac05800baed9&jsenabled=true##). 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000089/hu

man_med_000683.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000802/hu

man_med_000899.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000297/hu

man_med_000916.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000778/hu

man_med_000620.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000527/hu

man_med_000760.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000273/hu

man_med_001010.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_0

00345.jsp&mid=WC0b01ac05800baed9&jsenabled=true 

http://www.afssaps.fr/content/download/35302/460749/version/1/file/RapportNanoDM_GB_A

155  

out2011.pdf 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_q_056.pdf 

EN 

25 

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nanomaterials used as UV-filters (titanium dioxide, zinc oxide, ETH-50, HAA299).156 On 11 
November 2011, SCCS concluded that the use of 10% ETH-50 is safe for dermal application 
but  that  sprays  containing  ETH-50  cannot  be  recommended  until  additional  information  is 
provided. The evaluation of the other three materials is ongoing. 

Absence of product recalls 

The  EU  has  two  rapid  alert  systems,  one  for  products  (Rapid  Alert  System  for  Non-Food 
Dangerous Products, RAPEX157) and one for food and feed (Rapid Alert System for Food and 
Feed, RASFF158). No nanomaterial has so far been recalled under RAPEX or RASFF. 

5.2. 

REACH registration dossiers 

In  close  collaboration  with  ECHA,  the  Commission  has  assessed  how  nanomaterials  have 
been addressed in REACH registration and CLP notification dossiers. At the end of February 
2012, 7 registrations and 18 notifications had ticked the voluntary field "nanomaterial" as the 
form  of  the  substance159.  The  further  assessment  identified  three  groups  of  registration 
dossiers,  where  a)  the  registrants  recognized  nanomaterials  (8  dossiers  /5  substances);  b) 
substances exist only as nanomaterial (12/9), and c) the assessors identified nanomaterials on 
the  basis  of  the  particle  size  distribution  (5/5).  It  is  possible  that  additional  substances  with 
nanoform(s)  may  have  been  registered  or  notified  but  were  not  retrieved  from  the  REACH 
and CLP database when the search-term "nano" was not used in any text field in the dossier or 
when the other search criteria used were not fulfilled. 

In the assessed dossiers, different ways were used to present identification of substances that 
include or in one case exclude, nanoforms, and to organize nanoform(s) relevant information. 
Within groups a) and b) data could generally be linked to nanomaterial but, in particular for 
the a) group, its data quality was often in question due to the lack of justification or adequate 
characterisation of the addressed nanoform(s) or the testing material. For the group c) it was 
not  possible  to  distinguish  which  data  are  for  nanomaterial.  These  findings  can  partly  be 
explained by the absence of detailed guidance to registrants on registration for nanomaterials, 
the absence of a definition of nanomaterial and the general wording of the REACH annexes. 

5.3. 

The  conclusions  from  RIPoNs  on  the  applicability  of  the  testing  strategies  to 
nanomaterials  

The  Commission’s  Joint  Research  Centre  carried  out  a  number  of  REACH  Implementation 
Projects  on  Nanomaterials  (RIP-oNs)  to  evaluate  the  applicability  of  the  existing  REACH 
guidance  to  nanomaterials,  and  if  needed,  to  develop  specific  advice  on  how  the  guidance 
could be updated to better address nanomaterials. Three reports are available:  

RIP-oN  1  relates  to  "Substance  identification  of  nanomaterials".  Under  REACH,  substance 
identification  determines  whether  substances  must  be  registered  separately  or  data  on  the 
same  substance  must  be  shared  between  the  registrants.  The  objective of  the  project  was  to 
evaluate  the  applicability  of  existing  guidance  and,  if  needed,  to  develop  specific  advice  on 

156  
157 
158 
159  Updated  figures  for  REACH  registrations  based  on  new  submissions;  for  original  assessment  see  SWP, 

http://ec.europa.eu/health/scientific_committees/consumer_safety/requests/index_en.htm 
http://ec.europa.eu/consumers/safety/rapex/index_en.htm 
http://ec.europa.eu/food/food/rapidalert/index_en.htm 

appendix 3 

EN 

26 

   EN 

                                                 
 
how  to  establish  the  substance  identity  of  nanomaterials.  The  opinions  of  the  participating 
experts from Member State Competent Authorities, industry, NGOs and ECHA diverged on 
several key issues, including whether size or surface treatment/functionalisation should affect 
substance identification or characterization of physicochemical properties. It was not possible 
to  reconcile  these  opinions.  Therefore,  the  report160  mainly  describes  options/approaches 
rather  than  providing  explicit  recommendations.  ECHA  has  been  asked  to  develop  such 
recommendations as  it  starts  gaining  practical experience through the evaluation of relevant 
registration dossiers.  

The  objectives  of  the  RIP-oN  2  report  on  "Specific  Advice  on  Fulfilling  Information 
Requirements  for  Nanomaterials  under  REACH”161  were  to  provide  advice  how  REACH 
information  requirements  on  intrinsic  properties  of  nanomaterials  can  be  fulfilled,  including 
the  appropriateness  of  the  relevant  test  methods  (and  dosimetry)  for  nanomaterials,  and 
outline, when relevant, possible specific testing strategies. It was also set to provide advice on 
the  information  that  is  needed  for  safety  evaluation  and  risk  management  of  nanomaterials. 
The  objective  of  the  RIP-oN  3  project  "Specific  Advice  on  Exposure  Assessment  and 
Hazard/Risk  Characterisation  for  Nanomaterials  under  REACH"  was  to  develop  advice  on 
how  to  do  exposure  assessment  for  nanomaterials  within  the  REACH  context  and  how  to 
conduct hazard and risk characterisation for nanomaterials.  

Neither RIP-oN 2 or RIP-oN 3 specifically addressed presentation of information on multiple 
nanoforms within dossiers (RIP-on 1 task) or the practical implications of multiple nanoforms 
of  the  same  substance  for  chemical  safety  assessment.  The  reports  however  recognize  the 
possibility,  when  scientifically  justified,  to  apply  the  same  data  for  different  forms  and 
substances (read across, grouping) and to use non-testing approaches (e.g. (Q)SAR, in silico). 
They  also  recommend  further  research  on  non-testing  approaches  as  a  high  priority  to  be 
addressed within the short term. 

RIPoN  2  concludes  that  the  existing  guidance  and  the  information  requirements  on 
(eco)toxicological  data  (based  on  the  OECD  Test  Guidelines  and  ISO/CEN  standards)  are 
considered  applicable  for  the  assessment  of  nanomaterials.  Attention  needs  to  be  given  to 
measuring, dosing, delivery and tracking of nanomaterials in the test system. Representative 
sample  preparation  and  thorough  and  accurate  physico-chemical  characterisation  using 
multiple  techniques  are  an  essential  component  of  assessing  the  potential  (eco)toxicity  of 
nanomaterials. The report proposes the introduction of additional physico-chemical property 
information requirements and of an advisory note on sample preparation. 

The  guidance  on  physico-chemical  properties  was  considered  to  be  generally  applicable  to 
nanomaterials. However, the limited relevance and applicability of the property and methods 
for  surface  tension,  flash  point  and  viscosity  was  recognized,  and  the  further  evaluation  of 
suitability of existing methods for water solubility, partition coefficient, adsorption/desorption 
was recommended.  

The guidance on toxicological Information Requirements is considered applicable, although it 
was highlighted that attention needs to be given to measuring, dosing, delivery and tracking of 
nanomaterials  in  the  test  system.  In  general,  the  basic  ecotoxicological  properties  and 
endpoints described in the OECD Test Guidelines for the determination of potential effects of 
test  substances  in  relevant  environmental  compartments  (aquatic,  terrestrial,  sediment)  after 

160 
161 

http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon1.pdf 
http://ec.europa.eu/environment/chemicals/nanotech/pdf/report_ripon2.pdf 

EN 

27 

   EN 

                                                 
acute or chronic exposure were considered adequate and relevant for nanomaterials. However, 
the report acknowledges the fact that OECD Test Guidelines were not specifically designed 
for the testing of nanomaterials, and the guidance provided on important measurement aspects 
such as the sample preparation, the delivery of test substances to test system or the exposure 
quantifications/metrics,  in  all  of  these  test  guidelines  is  considered  to  be  insufficient  for 
testing  of  nanomaterials.  These  issues  have  been  preliminarily  addressed  in  the  OECD 
specific Preliminary Guidance Notes on Sample Preparation and Dosimetry.162 

The identified potential additional relevant specific intrinsic properties include: 

(a) 

(b) 

(c) 

Physico-chemical  properties  (Particle  shape,  Surface  area,  Surface  energy,  Surface 
chemistry, Surface charge, Redox potential, Cell-free ROS/RNS production capacity, 
State  of  dispersion,  State  of  agglomeration).  Additional  guidance  chapters  were 
recommended only for shape and surface area; 

Toxicological endpoints (Cell uptake, Cell viability, Oxidative stress, Inflammation, 
toxicity);  no  additional 
Fibrosis,  Immunotoxicity/sensitisation,  Cardiovascular 
guidance chapter for them was recommended; 

Ecotoxicological  endpoints,  Ventilation  rate,  Gill  pathologies,  Mucus  secretion, 
Brain  pathology,  Animal  behaviour,  Oxidative  stress  biomarkers163;  no  additional 
guidance chapter for them was recommended. 

sample  preparation  and 

On  certain  endpoints164  there  was  limited  or  no  body  of  evidence  available  to  inform  the 
provision  of  specific  practical  advice.  The  published  scientific  evidence  demonstrated  that 
representative 
thorough  and  accurate  physico-chemical 
characterisation using multiple techniques is an essential component of assessing the potential 
(eco)toxicity of nanomaterials. Factors such as the exposure method, dose selection, species 
used,  cell  type  under  investigation,  as  well  as  coating/functionalisation  of  the  surface  and 
particle impurities, release of free metal ions and particle aggregation all have the potential to 
impact  on  the  assessed  (eco)toxicity  of  nanoparticles.  The  full  extent  of  influence  of  these 
factors on (eco)toxicological impact of nanomaterials is however still emerging. 

While,  in  general,  it  was  reported  that  only  minor  updates  are  necessary  to  some  of  the 
existing Integrated Testing Strategies (ITS) for the intrinsic properties/endpoints considered, a 
substantive update to the ITS for particle size analysis (or granulometry) was recommended, 
together with the expressed need to justify scientifically the use of QSAR and/or read-across. 
Advice  was  provided  on  the  scientific  basis  for  the  categorisation  of  nanomaterials  and 
application  of  in  silico  methods,  read-across  and  category  approaches  for  deriving  hazard 
information  for  nanomaterials  from  the  information  on  bulk  substances  or  from  comparison 
between  nanomaterials.  Whilst  the  lack  of  data  across  a  wide  range  of  structural  and 
compositionally different nanomaterials precludes a fully prescribed category-based approach 
being  developed,  the  suggested  approaches  for  possible  development  indicate  where  such 
groupings may be applied. 

162 

163 
164 

OECD  No.  24  -  ENV/JM/MONO(2010)25:  Preliminary  Guidance  Notes  on  Sample  Preparation  and 
Dosimetry for the Safety Testing of Manufactured Nanomaterials. 
The report indicates CAT, SOD, GPX, GST biomarkers. 
E.g. dermal and respiratory sensitisation and irritation, ecotoxicological endpoints. 

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RIPoN  3  concludes  that  there  is  still  very  limited  evidence  to  draw  any  generalized 
conclusions  or  recommendations  for  the  chemical  safety  assessment  of  nanomaterials  under 
REACH.  Known  exposure  assessment  methods  are  generally  applicable  but  may  still 
experience methodological challenges, such as how to distinguish manufactured nanoparticles 
from  background  level  of  natural  and  incidental  nanoparticles.  No  new  nano-specific  risk 
management  measures  need  to  be  developed,  but  it  is  important  to  include  specific 
information on nanomaterials in the safety data sheets (SDS) and assess the effectiveness of 
measures in place to ensure adequate protection. Due to lack of evidence, no recommendation 
is provided regarding risk management measures relating to the environment or the consumer. 

The  exposure  scenarios  (ES)  case  studies  performed  under  RIPoN-3  highlighted  general 
difficulties  with  the  application  of  current  guidance  to  nanomaterials.  The  ‘hierarchy  of 
control’  concept  which  underpins  much  of  the  Operational  Conditions  (OC)  and  Risk 
Management Measures (RMM) REACH guidance in this area was considered to be equally 
valid for nanomaterials as for other substances. There is evidence that already known control 
and  risk  management  methodologies  can  provide  levels  of  protection  for  workers  from 
exposure  to  engineered  nanomaterials.  It  was  not  considered  necessary  to  recommend  the 
development of new nano-specific RMMs. However, the specific protection provided against 
specific  nanomaterials  needs  to  be  evaluated.  The  project  found  that  current  exposure 
estimation  models  are  not  validated  for  nanomaterials  and  should  not  be  used  for 
nanomaterials without accompanying measurement data or scientific justification. 

Emissions  to  the  workplace  may  be  substantially  reduced  if  a  process  involving  engineered 
nanomaterials  is  performed  in  a  properly  designed  enclosure/containment,  especially  when 
adequately addressing what happens when the containment is opened. Worker exposure can 
be significantly reduced or prevented through the use of correctly designed and implemented 
extraction ventilation and filtration. Filtration theory indicates that filtration will be effective 
for particles in the nanometre size range. This also applies to personal protective equipment, 
where  several  studies  clearly  demonstrate  the  potential  of  respirator  filters  to  capture 
nanoparticles. As for chemicals in general, further work is required to evaluate human factors 
such as leakage around face-piece filter and test protective suits and gloves. 

The  RIP-oN  3  report  states  that  at  current  stage,  Control  Banding  (CB)  cannot  be  used  to 
demonstrate  that  the  risks  are  adequately  controlled,  but  might  support  users  in  initial 
selection of control measures. No guidance can be given at this time as regards preliminary 
medical  surveillance  activities,  though  they  are  likely  to  be  beneficial  in  the  long  term. 
Similarly, no recommendations for risk management measures in REACH guidance relating 
to the environment or consumer exposure can be made at this time, due to lack of evidence.  

For safety data sheets (SDS), it is important that information provided for a nanomaterial is 
representative, valid and provides the protection needed for the forms addressed by the SDS.  

Some  of  the  key  issues  in  exposure  estimation  are  the  discrimination  from  background 
nanoparticles and the adequate consideration of high spatial and temporal variability. The full 
particle  size  distribution  curve  as  well  as  presence  of  ‘bundles’  or  ‘clumps’  of  high  aspect 
ratio  nanomaterials  should  be  reported  when  measuring,  and  model  estimates  should  not  be 
relied  on  alone  without  scientific  justification  and  further  confirmation  of  their  validity  in 
individual  cases.  Adequate  particle  characterisation  within  test  systems  as  well  as  the 
exposure  environment  is  important  as  e.g.  aggregation/agglomeration  of  nanoparticles  may 
affect  standard  toxicity  tests  and  affect  parameters  such  as  deposition  zone  in  the  lung  or 
uptake by organisms. 

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For  the  most  part,  the  current  guidance  in  relation  to  deriving  exposure  limits  provides 
sufficient flexibility to address areas of uncertainty, data gaps and, if justified, deviations from 
the  default  approach  and  the  current  assessment  factors  derived  from  classical  (soluble 
substance)  toxicity.  Regarding  hazard  and  risk  characterisation,  an  alternative  approach  for 
extrapolating from experimental animals to humans for inhalation exposure was suggested for 
consideration and development.  

RIP-oNs 2 and 3 work identified the critical items on exposure/dose descriptors and outlined 
needs  for  adequate  exposure  assessment  metrics/parameters  compatible  with  those  used  for 
hazard assessment. The metrics currently used in risk assessment across exposure, toxicology 
and risk, are based on mass or number. Based on toxicological evidence on inflammation, the 
most prominent emerging alternative or additional metric is surface area. With no definitive 
conclusions  on  the  best  dose  metric,  there  was  consensus  that  there  should  be  sufficient 
characterisation of the forms of a substance tested to allow the dose response to be expressed 
in the different metrics discussed - number, surface area and mass. There are other parameters 
as  well  which  can  act  as  modifiers  of  the  toxicity,  including  particle  size,  size  distribution, 
these 
density,  surface  modification,  aggregation/agglomeration  state  and  shape,  but 
parameters would not generally be considered as scalable dose quantities and do not therefore 
appear to conform to the current use of the term “metric” under REACH.  

A  comprehensive  synthesis  of  findings,  implications,  issues  and  advice  was  developed  and 
integrated  through  the  Task  Reports  and  the  Final  Project  Report  of  the  RIP-oN2  and  RIP-
oN3. Where considered relevant, feasible and justified, specific advice for updating REACH 
guidance was provided. For issues which were not currently technically/scientifically mature 
for  developing  detailed  guidance,  the  need  for  further  research  and  development  was 
indicated. It must be noted in any case that the update of REACH guidance and thus inclusion 
of any of the advice from the reports into the ECHA guidance is exclusively the responsibility 
of ECHA.  

5.4. 

JRC Nanohub  

The European Commission’s Joint Research Centre’s (JRC) NANOhub is a comprehensive, 
non-public IT platform designed for addressing and hosting information on nanomaterials. It 
is based on IUCLID, which provides an accepted basis for regulatory use of data on chemicals 
in  the  EU.  With  its  web-based  functionality  it  is  intended  to  boost  interconnections  and  to 
facilitate synergies for collaboration within research projects.  

It has been developed on behalf of the JRC as a tool to address nano-safety and measurements 
of nanomaterials, supported by an international stakeholder network from academia, industry, 
Member States, ISO, CEN, OECD, and NGOs. The JRC NANOhub hosts, among others, data 
and  studies  from  the  OECD  Working  Party  on  Manufactured  Nanomaterials  (WPMN) 
sponsorship programme on the safety testing of a representative set of nanomaterials, as well 
as  test  and  measurement  results  on  materials  from  the  JRC  Repository  of  Representative 
Nanomaterials (see also Appendix 9). 

The  data  structure  builds  on  IUCLID  chapters  and  on  the  OECD  Harmonised  Templates. 
These  chapters  have  been  expanded  to  add  additional  templates  for  nanomaterial-specific 
endpoints  listed  by  the  OECD  WPMN  in  the  Guidance  Manual  of  the  sponsorship 

EN 

30 

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programme.165  Once  these  new  templates  have  been  tested  and  finalised,  they  will  be 
submitted to the OECD for harmonisation and possible implementation in IUCLID. 

JRC NANOhub provides features to address data quality, to create reports and dossiers, and to 
exchange  data,  and  it  provides  collaborating  parties  with  a  facilitated  frame  for  hosting  and 
sharing data. In this way it facilitates cooperation between international parties and research 
projects  using  the  World  Wide  Web.  JRC  NANOhub  consists  of  independent,  consortium-
specific  installations  hosted  by  the  JRC  with  options  to  protect  confidentiality  but  also  to 
share  results  between  different  consortia.  A  listing  of  hosted  projects  can  be  found  on 
www.nanohub.eu. 

5.5. 

Organisation for Economic Co-operation and Development: Working Party on 
Manufactured Nanomaterials  

In 2006 the OECD Working Party on Manufactured Nanomaterials (WPMN) was established, 
bringing together relevant Ministries and Agencies responsible for human and environmental 
safety, as well as representatives from other stakeholder groups.  

A formal four-year programme of work was endorsed by the OECD Chemicals Committee to 
cover  the  period  2009  to  2012  which  aimed  at  the  development  of  a  globally  harmonised 
approach to the management of nanomaterials. 

The WPMN published a booklet166 in February 2011 summarising the first five years of the 
programme, noting in that report its work on: 

• 

• 

• 

• 

• 

Testing  specific  nanomaterials  for  their  human  health  and  safety  evaluation,  while 
ensuring  appropriate  testing  methods  (in  vivo  &  in  vitro),  in  addition  to  promoting 
the development of alternative test methods to nano-toxicity testing;  

Promoting co-operation on voluntary schemes and regulatory programmes;  

Facilitating international co-operation on risk assessment strategies;  

Developing  guidance  on  exposure  measurement  and  exposure  mitigation  at  the 
workplace, for consumers and for the environment; and; 

Promoting the environmentally sustainable use of nanotechnology through enhancing 
the  knowledge  base  about  life  cycle  aspects  of  manufactured  nanomaterials.  This 
should be done at their different stages of development and applications. 

This  work  has  already  started  to  generate  guidance  literature  for  those  working  in  this  field 
such  as  'Preliminary  Guidance  Notes  on  Sample  Preparation  and  Dosimetry'167  and  a 

165  
166 
167

ENV/JM/MONO(2009)20/REV 
A full version of the document can be found at http://www.oecd.org/dataoecd/6/25/47104296.pdf. 

http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2010)25&do

clanguage=en 

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'Guidance Manual for the Testing of Manufactured Nanomaterials (First Revision)'.168 A full 
list of relevant OECD publications can be found on the dedicated WPMN website.169 

The ninth meeting of the WPMN took place in December 2011 to examine progress made on 
the current work plan. The tenth meeting of the WPMN is scheduled for June 2012. 

5.6. 

Strategic Approach to International Chemicals Management (SAICM) 

In  2006  the  International  Conference  on  Chemicals  Management  (ICCM)  adopted  the 
Strategic  Approach  to  International  Chemicals  Management  (SAICM).170  This  provides  a 
UNEP level policy framework to promote chemical safety around the world. 

In  May  2009  ICCM2  adopted  Resolution  II/4  on  emerging  policy  issues  which  covered  the 
specific  issue  of  nanotechnologies  and  manufactured  nanomaterials,  recognising  their 
potential benefits and potential risks to human health and the environment. 

Since  then  work  has  been  taken  forward  to  build  a  fuller  understanding  of  this  issue.  The 
above  Resolution  prompted  a  number  of  Regional  workshops  on  the  issue  led  by  UNITAR 
and  the  OECD  and  also  the  drafting  of  a  Report171  on  nanomaterials  within  the  context  of 
SAICM which was presented to the SAICM Open Ended Working Group in November 2011. 
Also during this meeting work was undertaken to develop actions that could be added to the 
Global  Plan  of  Action  (which  acts  as  a  guidance  document  and  working  tool  to  support 
implementation)  in  due  course.  This  issue  will  be  revisited  during  ICCM3  which  is  due  to 
take place in September 2012. 

5.7. 

Research on nanomaterial safety 

The  European  Commission  has  started  funding  projects  specifically  addressing  nanosafety 
since the 5th EU Framework Programme for Research and Technological Development (FP5, 
1998-2002), with a regular budget increase. So far, 46 nanosafety projects have been funded. 
They represented a total EU investment of 130 M€ (corresponding to a total projects costs of 
185 M€). The framework programme calls are conceived to cover all aspects necessary for the 
risk assessment and risk management of nanomaterials: physico-chemical characterisations of 
nanomaterials,  fate  and  behaviour  in  biological  and  environmental  media,  bio-nano 
interactions,  nano-toxicity  and  nano-ecotoxicity,  life  cycle  analysis  of  nanomaterial-
embedded products (including recycling and final treatment), measurement devices, exposure, 
worker protection, risk assessment tools and risk management strategies.  

The  EU  projects  are  requested  to  join  forces  through  the  NanoSafety  Cluster  to  maximise 
synergies, to facilitate the formation of a consensus on nanotoxicology in Europe; to improve 
the  coherence  of  nanotoxicology  studies  and  harmonize  methods;  and  to  provide  a  single 
voice  for  discussions  with  external  bodies  and  to  provide  industrial  stakeholders  and  the 
general public with appropriate knowledge on the risks of nanoparticles and nanomaterials for 
human health and the environment. 

168

169 
170 
171 

EN 

http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev

&doclanguage=en 
http://www.oecd.org/document/53/0,3746,en_2649_37015404_37760309_1_1_1_1,00.html 
http://www.saicm.org/index.php?ql=h&content=home 
http://www.saicm.org/index.php?content=meeting&mid=124&def=4&menuid= 

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6. 

INFORMATION  AND  DATABASES  ON  THE  USE  OF  NANOTECHNOLOGY  AND 
NANOMATERIALS 

The  European  Parliament  has  called  on  the  Commission  to  compile  “an  inventory  of  the 
different types and uses of nanomaterials on the European market, while respecting justified 
commercial  secrets  such  as  recipes,  and  to  make  this  inventory  publicly  available”.  172  The 
Council invited the Commission to “evaluate the need for […] the further development of a 
harmonized database for nanomaterials, while considering potential impacts.” 173 

While  the  European  Parliament  does  not  specify  the  meaning  of  the  term  “inventory”,  in 
particular  on  whether  this  inventory  should  be  presented  in  the  form  of  a  document  or 
database, the Council invites the Commission to evaluate the need for the further development 
of a harmonized  database.  The  Commission therefore has, in addition to the information on 
types  and  uses  of  nanomaterials  in  section  3  and  Appendix  2  of  this  document,  compiled 
information  on  existing  databases  in  section  6.1  and  Appendix  8.  Section  6.2  gives 
information on plans to set up a European Commission web platform on nanomaterial types 
and uses, including safety aspects.  

6.1. 

Existing databases on, or with relevance to, nanomaterials on the market 

Databases  on  nanomaterials  on  the  market  can  in  principle  be  structured  either  from  the 
perspective  of  nanomaterials  (and  possibly  cover  their  uses  in  products  in  more  or  less 
concrete terms) or from the perspective of products on the market containing nanomaterials. 
Both  approaches  have  been  used  in  different  existing  databases.  There  are  also  databases 
which have elements of both. In addition, the nature of databases differs largely. An overview 
of existing databases is contained in Appendix 8.174 

A  database  with  a  clear  substance-structure  is  REACH-IT.175  REACH  registrations  for 
substances are stored in the REACH-IT database. REACH is specific for substances and it is 
possible to indicate that the registered substance is a nanomaterial or includes nanoforms in 
REACH registrations (for example, there is a voluntary tick-box to identify the substance or 
form of a substance as a nanomaterial). There is also ECHA advice on how to enter relevant 
data in IUCLID. This information is retrievable from the registration database. It is however 
not  always  easy  to  identify  which  information  relates  to  the  nanoform(s)  and  which 
information  to  the  bulk  form(s)  of  the  substances.  Also,  the  description  of  uses  in  REACH 
dossiers is rather generic, and therefore it is not possible to identify concrete applications from 
the REACH dossiers. A screening of the REACH registration dossiers and CLP notifications 
was  performed  to  identify  information  about  substances  in  the  nanoform.  Methodology  and 
outcome of this work is reported in Appendix 3. 

An  example  of  a  mixed  database  is  ObservatoryNano.176  Although  the  main  aim  of  the 
database  is  not  an  exhaustive  inventory  of  nanomaterials  and  their  uses  on  the  market,  it 
contains  a  number  of  factsheets,  briefings  and  reports  which  give  an  overview  of 
nanomaterials, as well as product areas in which those substances are used. The database has a 

172 

173 
174 

175 
176 

http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-2009-
0328&language=EN 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/envir/118646.pdf 
Based  on  "Development  of  an  inventory  for  consumer  products  containing  nanomaterials", 
http://ec.europa.eu/environment/chemicals/nanotech/pdf/study_inventory.pdf. 
http://apps.echa.europa.eu/registered/registered-sub.aspx#phasein 
http://www.observatorynano.eu/project/ 

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relatively  strong  focus  on  new  developments  in  terms  of  research  and  innovation,  and 
therefore  does  not  always  distinguish  between  widespread  commercial  use  of  nanomaterials 
and applications at the pre-market stage. 

Moreover,  there  is  a  series  of  databases  focusing  on  products  on  the  market  containing 
nanomaterials.  Examples  for  such  databases  include  the  Woodrow  Wilson  database  (“The 
Project  on  Emerging  Nanotechnologies”)177,  the  ANEC-BEUC  2010  inventory  of  consumer 
products  containing  nanomaterials  (ANEC-BEUC  2010)178,  the  online  database  of  the 
German  Environmental  NGO  ‘BUND’  (Friends  of  the  Earth  Germany)179,  and  the 
nanotechnology products database of Nanowerk.180 Those databases are all attempts to collect 
as  much  information  as  possible  on  products  containing  nanomaterials  at  the  level  of 
individual products and brands. However, they are neither based on systematic data collection 
over  a  wide  range  of  products,  nor  is  it  certain  that  the  products  mentioned  indeed  contain 
nanomaterials.  This  is  because  the  databases  are  at  least  partly  based  on  claims  by 
manufacturers  which  may,  or  may  not  be  correct.  Given  the  multitude  of  applications 
identified in the course of the analysis of nanomaterials on the market (see Appendix 2) and 
the  limited  number  of  products  identified  (e.g.  around  1300  products  worldwide  for  the 
Woodrow Wilson database), it seems however likely that those databases only cover a very 
small fragment of products containing nanomaterials on the market. 

There are also a number of voluntary one-off reporting schemes in EU Member States such as 
the United Kingdom, France, Denmark, Germany and Ireland, as well as in several non-EU 
countries.181 However, those schemes only received very little feedback and generally do not 
give a satisfactory overview of nanomaterials on the market. France has recently introduced 
regulatory  measures  for  a  mandatory  registry  for  substances  at  nanoscale,  mixtures  from 
which nanomaterials can be released, and articles with an intended release of nanomaterials. 

In addition to the product databases listed above, an overview is presented in Appendix 8 on 
databases  not  predominantly  considering  products,  but  containing  information  related  to  the 
potential toxicity or hazard of nanomaterials. Two of those databases provide information on 
experimental data and the projects and/or organisations in which these data are obtained. Two 
other databases specifically focus on industry needs.  

(2) 

(3) 

(4) 

(5) 

6.2. 

The OECD Database on Research into Safety of Manufactured Nanomaterials  

JRC NanoHub  

nanotech-data.com 

nanoproducts.de 

Plans  for  a  European  Commission  web  platform  on  types  and  uses  of 
nanomaterials, including safety aspects 

The interest in an inventory/harmonised database expressed by the European Parliament and 
the Council reflects a widely perceived lack of information on nanomaterials on the market. 

177 
178 
179 
180 
181 

http://www.nanotechproject.org/inventories/consumer/ 
www.beuc.org 
http://www.bund.net 
http://www.nanowerk.com/products/products.php 
for more information: http://nanomaterialsconf.eu/documents/Nanos-Reporting-Mechanisms.pdf. 

EN 

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Existing  databases  are  either  not  clear  enough  on the  types  of  uses  of  nanomaterials,  or  are 
rather sketchy and incomplete in terms of products containing nanomaterials. In some cases, 
there is little quality control of the information, and therefore there are doubts on the factual 
correctness  of  at  least  part  of  the  contained  information.  The  Commission  therefore  has 
gathered available information in Appendix 2 to this Staff Working Paper.  

However,  the  Commission  understands  that  there  is  an  interest  in  keeping  this  information 
updated  and  completed  by  new  information  on  nanomaterials  and  products  containing 
nanomaterials. The Commission is ready to host an inventory in the form of a web platform 
on nanomaterials and their uses. Preparatory work to set up such a web platform, led by the 
Commission’s Joint Research Centre, has already started. Discussions among the responsible 
Commission  services  on  capturing  specific  requirements  have  been  initiated  in  order  to 
support  the  European  Commission's  policies  such  as  environment,  consumers,  health, 
business, employment and innovation.  

The  web  platform  should  enable  the  user  to  retrieve  comprehensive  information  on 
nanomaterials, presenting that information in an easily searchable way and linking to the main 
information  sources  and  databases.    This  web  platform  will  both  present  general  summary 
information on nanomaterials and their uses, including safety aspects, building on the present 
Staff Working Paper, and link up to and build upon various existing or planned activities (e.g., 
JRC  NANOhub,  OECD  WPMN,  French  Grenelle  2  bill,  and  others).  Depending  on  the 
intended users of such a web platform (consumers, downstream/workplace users, regulators, 
researchers) it is necessary to consider what kind of information should be available to these 
different  groups,  and  certain  filtering  mechanisms  should  be  considered.  A  web  platform 
design would be advantageous which would be able to incorporate existing information and 
be at the same time capable of being adaptable to future options.  

Strengths and weaknesses of existing databases on nanomaterials and/or products containing 
nanomaterials  are  being  analyzed.  Publicly  available  databases/inventories  of  nanomaterials 
and their use often lack clear criteria for inclusion, quality assurance of the data content and 
being  up  to  date.  These  shortcomings  should  be  addressed,  and  for  the  part  of  information 
handled under the responsibility of the Commission, appropriate quality assurance, sustaining 
and periodic updating of the information should be guaranteed.  

Work towards a harmonized European web platform will benefit from the recently concluded 
project  on  “Development  of  an  inventory  for  consumer  products  containing  nanomaterials” 
carried out by RIVM on behalf of the Commission.182 A data model was already developed in 
that project to record a multitude of nanomaterial relevant information related to a product in 
a  structured  manner.  Furthermore,  a  methodology  was  developed  to  identify  consumer 
products  on  the  EU  market  containing  nanomaterials,  and  it  was  subsequently  used  to 
populate a pilot version of a searchable database containing such products.  

When setting up such a harmonised Commission database it will also be necessary to take into 
account  the  situation  in  Member  States  where  regulatory  measures  (France)  or  discussions 
were already initiated in parallel to activities within the Commission. 

182 

http://ec.europa.eu/environment/chemicals/nanotech/index.htm 

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Appendix 1 
Types of nanomaterials  

1. 

INTRODUCTION 

This  Staff  Working  Paper  is  focused  on  the  materials  that  meet  the  EU  definition  of 
nanomaterial (see Chapter 2). The EU has defined this single term while being well aware of 
the heterogeneous range of materials it covers, as shown in Chapter 3. This appendix provides 
an  overview  of  the  most  important  and  common  types  or  subcategories  of  nanomaterials, 
based on the EU definition of nanomaterial, but using also the more extensive nanomaterial 
terminology  developed  by  ISO.183  The  appendix  thereby  also  intends  to  clarify  the  relation 
between the EU and ISO nanomaterial definitions. 

Section  1  explains  and  defines  a  number  of  basic  terms  which  are  used  to  describe  and 
categorize nanomaterials. Section 2 lists the types of nanomaterials which are covered by the 
current EU definition of the term "nanomaterial". Section 3 discusses materials which do not 
comply  with  the  current  EU  definition,  but  which  fall  under  the  scope  of  the  broader  ISO 
definition of nanomaterial, and which may have to be considered in the review of the current 
EU definition, scheduled before end 2014. 

1.1. 

Basic terms and definitions 

Nanoscale 

The key term in most of the definitions of terms used in nanotechnology and nanosciences is 
the term nanoscale. Unless otherwise specified, and in accordance with ISO and EU practice, 
this term has in this document been used as short for the range from 1 nm to 100 nm.184  

Nano-objects  

ISO/TC  229  (the  ISO  Technical  Committee  on  Nanotechnologies)  invented  the  word  nano-
object and defined it (first in ISO/TS 27687:2008, later confirmed in ISO/TS 80004-1:2010) 
to describe particles which have at least one of their 3 (orthogonal) external dimensions in the 
nanoscale.185  Several  subclasses  of  nano-objects  are  distinguished,  such  as  nanoparticles 
(nano-objects with all 3 external dimensions in the nanoscale), nanofibres (grouping nanorods 
and nanotubes), and nanoplates.186 All particulate materials consisting for more than 50 % of 
nano-objects fall under the EU definition of nanomaterial. 

Aggregates and agglomerates, primary and secondary particles 

Nano-objects, like other particles, have a natural tendency to agglomerate: they form groups 
which  are  held  together  by  weak  forces  (e.g.,  van  der  Waals  forces)  or  by  simple  physical 
entanglement.  The  tendency  to  form  agglomerates  generally  increases  with  decreasing 

183 
184 

185 
186 

The ISO definitions of these terms can be found in the ISO Concepts database (http://cdb.iso.org). 
The fact that the EU definition does not refer to “approximately” 1-100 nm will in practice play little 
role in this typology which is not intended to refer to individual borderline cases but rather to general 
patterns. 
ISO TS 80004-1:2010 Nanotechnologies – Vocabulary – Part 1: Core terms 
CEN ISO TS 27687:2009 Nanotechnologies – Terminology and definitions for nanoparticles 

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particle  size  due  to  the  higher  surface  energy  and  because  inertial  forces,  which  can 
'deconstruct'  agglomerates  for  example  during  sonication,  become  relatively  less  important 
with decreasing volume/surface area ratio. 

Often,  nano-objects  are  encountered  in  the  form  of  aggregates.  Aggregates  are  groups  of 
particles which, unlike agglomerates, are held together by strong forces (for example covalent 
chemical  bonds)  or  by  complex  physical  entanglement.  Aggregates  are  most  often  created 
during the processing of the nano-objects, e.g., when they are formed in a hot gaseous phase 
and collide with each other at a temperature above or near to their melting temperature. 

Both  aggregates  and  agglomerates  are  also  called  secondary  particles,  as  they  consist  of 
groups  of  smaller,  so-called  primary  particles.  It  is  difficult  and  often  impossible  to  turn 
aggregates back into individual primary particles other than by high-energy processes such as 
mechanical  milling  or  abrasion.  On  the  other  hand,  the  number  of  primary  particles  in  an 
agglomerate  can  change  easily,  e.g.,  under  the  influence  of  changing  environmental 
conditions. Correspondingly, the methods to distinguish between agglomerates and aggregates 
are based on the detection of the change in size of the secondary particles upon sonication or 
upon the change of pH or other environmental conditions.  

Both  agglomerates  and  aggregates  of  nano-objects  are  covered  by  the  EU  definition  of 
nanomaterial. 

Nanostructure 

The  current  ISO  definition  for  nanostructure  is  'a  composition  of  inter-related  constituent 
parts, in which one or more of those parts is a nanoscale region, where a region is defined by a 
boundary  representing  a  discontinuity  in  properties'187  Examples  of  a  nanoscale  region  are 
nanophases or nanopores.  

Dispersion 

A dispersion is a material that consists of a dispersing medium (a continuous, matrix phase) 
and a dispersed phase (a collection of particles or small phases of the same kind, which are 
separated  from  each  other  by  the  dispersing  medium).  Both  the  dispersing  medium  and  the 
dispersed phase can be solid, liquid or gaseous, leading to a number of possible combinations:  

Continuous 
phase 

solid 

Dispersed phase 

solid 

liquid 

gas 

(kind  of) 
material 

composite 

porous material filled 
with liquid 

liquid 

gas 

suspension 

aerosol 

emulsion 

aerosol 

porous 
material  filled 
with gas 

foam 

(does 
apply) 

not 

187 

ISO TS 80004-1:2010 Nanotechnologies – Vocabulary – Part 1: Core terms 

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1.2. 

Nanomaterials – general definitions 

The EU definition of nanomaterial 

The EU definition of nanomaterial has been shown in Chapter 2 of this Staff Working Paper, 
which explains how the definition was developed and on which materials it is focused. In the 
Recommendation  on  the  nanomaterial  definition,  the  Commission  commits  to  review  its 
current  definition  by  December  2014,  in  the  light  of  experience  and  of  scientific  and 
technological developments. In particular, the review should assess whether the number size 
distribution  threshold  of  50  %  should  be  increased  or  decreased  and  whether  to  include 
materials with internal structure or surface structure in the nanoscale such as nanoporous and 
nano-composite  materials.  For  this  reason,  it  is  useful  to  look  also  at  the  current  ISO 
definition,  which  is  broader  and  inter  alia  includes  nanostructured  materials  other  than 
aggregates and agglomerates. 

The International Organization for Standardization (ISO) definition of nanomaterial 

Section 1.1 lists a number of terms and concepts used to describe features of materials that are 
called nanomaterials. ISO has used these terms in its definition of the term nanomaterial in its 
Technical Specification 80004-1188:  

“A nanomaterial is a material with any external dimension in the nanoscale or having internal 
structure or surface structure in the nanoscale  

Note 1: This generic term is inclusive of nano-object and nanostructured material. 

Note  2:  See  also  engineered  nanomaterial,  manufactured  nanomaterial  and  incidental 
nanomaterial."  

As is the case for all ISO Technical Specifications, this definition will have to be confirmed in 
a full ISO standard, or be revised.189 Some of the questions to be solved are:  

– 

– 

is one single nano-object a nanomaterial?  

since all materials have a structure at the nanoscale, is everything a nanomaterial?  

The first question is implicitly answered in the EU definition, which considers nanomaterials 
to be particulate materials with a particle size distribution. Single nano-objects do not have a 
particle size distribution, and have no industrial or market relevance. It is expected that ISO 
will  consider,  inspired  also  by  the  EU  definition,  an  additional  term  such  as  particulate 
nanomaterial to cover 'materials consisting of nano-objects'. 

The second question is one of  the reasons why  nanostructured  materials  are  not  covered  by 
the  current  EU  definition.  ISO  has  considered  the  issue  of  nanostructured  materials  in  the 
recently released ISO TS 80004-4 (Nanotechnologies – Vocabulary – Part 4: Nanostructured 

188 
189 

ISO TS 80004-1:2010 Nanotechnologies – Vocabulary – Part 1: Core terms. 
ISO Technical specifications shall be reviewed at least every three years to decide either to confirm the 
technical specification for a further three years, revise the technical specification, process it further to 
become an International Standard or withdraw the technical specification. After six years, a technical 
specification shall be either converted into an International Standard or withdrawn. 

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Materials)190, which limits the nanoscale features that can turn a material into a nanomaterial, 
in the following way: 

"A  material  should  not  be  classified  as  nanostructured  based  solely  on  its  crystalline 
properties (three-dimensional arrangements of atoms or molecules forming a crystallite, short 
range  order  of  atoms  in  amorphous  or  quasi-amorphous  phases,  grain  boundaries, 
intragranular interfaces, dislocations, etc.). In contrast, materials with a grain size distribution 
having a significant fraction of grains in the nanoscale (nanocrystalline), voids and pores in 
the  nanoscale,  or  precipitations  in  the  nanoscale  (i.e.,  nano-objects  in  a  solid  matrix)  are 
sufficient features for materials to be classified as “nanostructured” (see ISO/TS 80004-1, 2.4 
nanomaterial).  Similarly,  almost  all  materials  always  have  surfaces  with  morphological  and 
chemical  heterogeneities  in  the  nanoscale.  Only  surfaces  that  have  been  intentionally 
modified  or  textured  to  have  morphological  or  chemical  heterogeneities  in  the  nanoscale 
identify materials as “nanostructured”." 

2. 

TYPES OF NANOMATERIALS MATCHING THE EU DEFINITION 

A number of materials meet both the current EU and ISO nanomaterial definitions. Basically, 
these  are  the  particulate  nanomaterials,  which  consist  of  nano-objects  or  contain  a  major 
fraction thereof. 

2.1. 

Nanostructured powders and nanopowders 

A powder is an assembly of discrete particles usually less than 1 mm in size.191 According to 
ISO/TS  80004-4  a  nanostructured  powder 
is  a  powder  comprising  nanostructured 
agglomerates,  or  nanostructured  aggregates,  or other  particles  of  nanostructured  material.  In 
this  definition,  the  nanostructured  aggregates  and  agglomerates  are  collections  of  individual 
nano-objects, and therefore they match the EU definition.  

It must be noted that no term has yet been assigned to powders consisting of non-aggregated 
and non-agglomerated nano-objects. ISO has the intention to close this gap, possibly using the 
term  nanopowder.  Conceptually  even  simpler  than  nanostructured  powders,  nanopowders 
seem to be the most straightforward kind of nanomaterials, matching also the EU definition. 
However, the term is of limited practical relevance given the strong tendency of nano-objects 
to  agglomerate.  To  avoid  the  agglomeration  of  nano-objects,  they  need  to  be  dispersed  in 
liquid (see section 2.2). 

The  family  of  nanostructured  powders  and  nanopowders  can  be  subdivided  based  on  the 
shape of the included nano-objects (equiaxial: nanoparticles; elongated: nanofibres, nanotubes 
or nanorods; flat: nanoplates). Alternatively, subdivisions can be made based on the element 
or compound of which the nano-objects consist. It is possible, at least in theory, to produce 
nanostructured powders of almost all elements or compounds which at ambient conditions are 
in the solid state (metals, polymers, ceramics). 

190 
191 

ISO TS 80004-4:2011 Nanotechnologies – Vocabulary – Part 4: Nanostructured Materials. 
ISO 3252:1999 Powder metallurgy – Vocabulary.  

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2.2. 

Nanosuspensions 

A nanosuspension consists of solid nano-objects suspended or dispersed in a liquid phase. A 
common term to denote a similar class of materials is the term 'colloid'. (Note: The upper size 
limit  of  the  particles  in  a  colloid  system  varies  in  different  definitions  of  the  term  between 
100 nm192 and 1000 nm.193) 

2.3. 

Nano-aerosols 

Nano-aerosols are materials which consist of a gaseous phase containing freely moving nano-
objects.  It  is  not  straightforward  to  produce  nano-aerosols  with  sufficient  stability  to  allow 
trade and transport. Rather, these materials are produced, intentionally or unintentionally, at a 
certain  place  and  time.  Both  intentionally  and  unintentionally  produced  nano-aerosols  are 
relevant  from  a  regulatory  point-of-view,  and  are  included  in  the  EU  definition  of 
nanomaterial, if the dispersed particles are solid. 

3. 

TYPES OF NANOMATERIALS NOT MATCHING THE EU DEFINITION 

A  number  of  materials  meet  the  ISO  (or  other)  nanomaterial  definition(s),  but  not  the  EU 
definition.  Basically,  these  are  nanostructured  materials  and  materials  containing  liquid  or 
gaseous 'particles'. The more common kinds of these materials are listed below.  

3.1. 

Nano-emulsions 

Nano-emulsions consist of liquid nano-objects suspended or dispersed in a liquid phase. They 
are not covered by the EU nanomaterial definition, because the term particle as defined in the 
Commission  Recommendation  is  intended  to  cover  only  nano-objects  with  a  defined,  rigid 
shape194, thus in essence solid nano-objects. 

3.2. 

Particles with an engineered nanoscale internal structure (if larger than 100nm) 

Nano-objects are particles with at least one external dimension at the nanoscale. There are an 
increasing  number  of  particles  which  are  engineered  to  have  internal  nanoscale  features. 
Examples  are  core-shell  particles  and  nano-encapsulates.  These  particles  may  be  designed, 
for example for pharmaceutical applications, where the inner core particle is "released" in a 
certain environment. Some of these materials have an external diameter smaller than 100 nm, 
matching  the  EU  nanomaterial  definition,  others  have  an  external  diameter  larger  than 
100 nm, not matching the EU nanomaterial definition. In ISO terms also the latter qualify as 
nanomaterials,  based  on  the  nanoscale  thickness  of  their  shell  or  capsule  or  based  on  the 
nanoscale diameter of the core particle. 

3.3. 

Nanocomposite materials 

Nanocomposite materials (or nanocomposites) consist of at least two different phases, at least 
one  of  which  has  nanoscale  features.  Well-known  examples  are  matrix  materials  reinforced 
with carbon nanotubes (e.g., polymer matrix composites with finely dispersed nanotubes for 
improved electrical conductivity).  

192 
193 
194 

ISO 1942-2-:1989, Dental vocabulary – Part 2: Dental materials. 
R.J. Hunter, Foundations of Colloid Science, Oxford University Press, 2001. 
http://ec.europa.eu/environment/chemicals/nanotech/questions_answers.htm, question 3. 

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There is a debate about the need to include more 'traditional' materials under this definition, 
such  as  steels  or  other  metals,  which  often  have  a  carefully  designed  microstructure  with 
nanoscale  elements  such  as  precipitates,  which  improve  for  example  the  mechanical 
properties of the material.  

3.4. 

Nanoporous materials and nanofoams 

Nanoporous materials  

Nanoporous  materials  are  materials  containing  a  fraction  of  small,  nanoscale  pores.  The 
defining  property  here  is  the  size  of  the  nanopore.  As  such,  they  are  not  covered  by  the 
nanomaterial  definition  (e.g.  zeolites).  However,  when  the  nanoporous  materials  consist  of 
aggregates/agglomerates  of  particles  in  nano-size  (see  Chapter  2.1),  they  fall  under  the  EU 
definition (e.g. silica gels). 

Liquid nanofoams 

A liquid nanofoam consists of nanoscale gas bubbles surrounded by liquid struts. They are not 
covered  by  the  EU  nanomaterial  definition,  because  the  term  particle  as  defined  in  the 
Commission  Recommendation  is  intended  to  cover  only  nano-objects  with  a  defined,  rigid 
shape195, thus excluding gas bubbles. 

Solid nanofoam and nanoporous material 

A solid nanofoam consists of nanoscale gas bubbles surrounded by solid struts. The defining 
property  can  be  either  the  size  of  the  nanopores  or  the  scale  of  the  strut  material.  Also,  the 
material can contain two continuous phases, if the pore volumes are interconnected, in which 
case it is the cross-section or thickness of the solid struts that has to be in the nanoscale. 

A nanoporous material is a solid material containing nanopores. The term is overlapping with 
the term nanofoam, but the fraction of pores in the nanoporous materials is more limited than 
in a nanofoam. 

195 

http://ec.europa.eu/environment/chemicals/nanotech/questions_answers.htm, question 3. 

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4. 

SUMMARY TABLE 

The  table  below  schematically  presents  the  types  of  nanomaterials  mentioned  in  sections  2 
and  3.  The  types  in  italics  match  the  EU  definition  of  nanomaterial,  with  the  additional 
condition that the number of nanoscale particles in the material exceeds 50 % in the particle 
number based particle size distribution. 

MATERIALS  CONSISTING 
OF NANO-OBJECTS 

NANOSTRUCTURED 
MATERIALS 

Powders of: 

- nanoparticles 

- nanoplates 

- nanofibres 

D
R
Y

F
L
U
D

I

Powders of nanostructured particles: 

-  aggregates/agglomerates  of  nano-
objects 

- particles with an engineered nanoscale 
internal 
core-shell 
particles  and  nano-encapsulates  with 
external diameter > 100 nm) 

structure 

(e.g. 

Fluid  dispersions  of  nano-
objects: 

Fluid  dispersions  of  nanostructured 
particles: 

- nanosuspensions 

- nano-emulsions 

- aerosols of solid nano-objects 

- aerosols of liquid nano-objects 

-  aggregates/agglomerates  of  nano-
objects 

- particles with an engineered nanoscale 
core-shell 
internal 
particles  and  nano-encapsulates  with 
external diameter > 100 nm) 

structure 

(e.g. 

Nanocomposite materials 

Nanoporous materials 

Nanofoams  

- liquid nanofoams 

- solid nanofoams 

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Appendix 2 
Nanomaterials on the EU market 

1. 

INTRODUCTORY REMARKS AND INFORMATION SOURCES 

This appendix is intended to give an overview of the nanomaterials on the market as well as 
their uses. Its focus is on giving an overall picture of the market, rather than being exhaustive 
or concrete in specific applications.  

those 

reports, 

the  chemistry  and  materials  sectoral 

Most of the information is taken from SRI Consulting reports.196 Those reports are explicitly 
referenced  to  where  they  concern  numbers  or  estimates  but  not  where  they  concern  general 
information. The general information on nanomaterials on the market and their applications is 
normally also from those reports if not otherwise quoted. In addition and on specific subjects 
not  covered  by 
reports  of 
ObservatoryNano197,  the  DaNa  Knowledge  Base  Nanomaterials198  or  other  public  sources 
were used. Where available, information is included on coverage of nanomaterials in REACH 
dossiers and classification and labelling by registrants. This information was taken from the 
ECHA website199 and the ECHA analysis on “Information on Nanomaterials retrieved in the 
ECHA Databases for REACH Registrations and CLP Notifications” (see Appendix 3) as well 
as joint work between ECHA and the Commission services analysing a number of registration 
dossiers  in  more  detail.  The  classification  information  is  mostly  (though  not  always) 
unspecific and it is difficult to deduce whether the information provided relates to the bulk or 
nanoform(s)  of  the  substance.  Information  on  the  reasons  for  (non)classification  (e.g.  data 
lacking, conclusive but not sufficient for classification, etc.) is given in footnotes. Moreover, 
this  appendix  takes  into  account  contributions  received  as  a  result  of  a  consultation  of  the 
members  of  the  REACH  and  CLP  Competent  Authorities  Subgroup  on  Nanomaterials 
(CASG(Nano), 
industry  and  non-
governmental organisations)200 on a draft of this appendix. Safety information is taken mainly 
from the ENRHES report201, EU-OSHA and the DaNa Knowledge Base Nanomaterials.202  

from  Member  States, 

representatives 

including 

In principle, this appendix follows the definition of nanomaterial as laid down in Commission 
Recommendation 2011/696/EU. However, in most cases the same substance exists in particle 
sizes below and above 100 nm, and it is sometimes unclear whether the collected information 
refers  to  one  or  the  other,  or  both.  Normally,  this  is  indicated  in  the  relevant  sections.  This 

196 

197 
198 

199 
200 
201 

202 

Source:  IHS  Inc. The  use  of  this  content  was  authorized  in  advance  by  IHS. Any  further  use  or 
redistribution  of  this  content  is  strictly  prohibited  a  without  written  permission  by  IHS.  All  rights 
reserved.  Reports  used:  Stefan  Schlag,  Bala  Suresh,  Masahiro  Yoneyama  and  Vivien  Yang, 
http://www.sriconsulting.com/SCUP/Public/Reports/NANOT000/; references to SRI in this annex refer 
to  this  report,  except  for  carbon  black,  where  information  was  taken  from  the  Chemical  Economic 
Handbook report on carbon black http://www.sriconsulting.com/CEH/Public/Reports/731.3000/.  
http://www.observatorynano.eu/project/catalogue/2CH/ 
http://www.nanopartikel.info/cms/lang/en/Projekte/dana; note that the database in many cases refers to 
“high dose” experiments. Such “high dose”-experiments describe situations which do usually not occur 
in normal life, neither for a customer nor at an industry’s workplace. High dose exposures could occur 
in case of an accident or a wanted uptake of nanoobjects. 
http://apps.echa.europa.eu/registered/registered-sub.aspx#phasein 
Document CASG Nano/03/2011. 
Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report. 
http://www.nanopartikel.info/cms/lang/en/Wissensbasis 

-  Review  of  Health  and  Environmental  Safety 

(ENRHES), 

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appendix is in principle structured according to chemical substances which are nanomaterials 
or  have  forms  which  are  nanomaterials.203  This  follows  in  essence  the  REACH  substance 
definition, without prejudice to whether the substance only exists as nanoform or whether the 
substance has different bulk and nanoforms. The presented information may either refer to the 
substance as such or to specific nanoforms, or, in certain cases to groups of substances (e.g. 
polymers)  or  even  broader  material  categories  (e.g.  quantum  dots).  This  is  done  because  it 
would not be possible to strictly distinguish all relevant information according to substance or 
form. Therefore, this listing is a pragmatic way to present information in the most structured 
way  possible  but  not  a  scientific  categorisation.  While  aiming  at  a  structured  approach  in 
describing the different nanomaterials addressing the relevant features, the level and detail of 
presented information varies significantly. This is because of strong differences in the quality 
and  detail  of  information  that  could  be  found.  If  information  that  is  given  for  some 
nanomaterials is missing for others, this normally means that relevant information could not 
be  identified  or  was  of  a  quality  which  was  considered  insufficient  for  presentation  in  this 
context. In the context of REACH registrations, the absence of information normally means 
that no relevant registration could be identified.  

Where  appropriate,  clarification  as  to  whether  information  relates  to  bulk  or  nanoforms  is 
provided  but  often  this  is  not  possible  and  the  information  is  presented  as  relating  to  the 
“substance” (in particular in the context of REACH registrations). There are also variations of 
the substances, reaction masses204 etc. which have been registered in addition to the below list 
but which are not detailed here because there is insufficient information to link them clearly to 
available market information. 

In general, the below information is focused on applications already on the market (including 
medical  applications).  Applications  at  the  stage  of  research  and  development  (R&D)  are 
normally  not  specifically  mentioned,  although  it  cannot  be  excluded  that  some  of  the 
information relates to products at R&D stage. There are also new types of nanomaterials in 
development,  which  are  often  referred  to  as  “second  generation”  (targeted  drug  delivery 
systems,  adaptive  structures  and  actuators),  “third  generation”  (novel  robotic  devices,  three-
dimensional  networks  and  guided  assemblies),  and  “fourth  generation”  (molecule-by-molecule 
design  and  self-assembly  capabilities)  nanomaterials.205,206,207  However,  those  are  either  at 
research  or  development  stage  or  at  an  early  stage  of  market  development.  Due  to  the  limited 
available  information  on  those  materials,  they  are  not  further  considered  in  this  Staff  Working 
Paper. 

Military  applications  are  normally  not  mentioned.  In  most  applications,  the  nanomaterial  is 
present  in  the  final  product,  either  as  aggregates  or  agglomerates  (rarely,  if  at  all,  as  free 
particles)  in  a  mobile  form  or  bound  in  a  matrix  or  included  in  closed  applications.  There 

203 

204 

205 

206 

207 

of 

this 

discussion 

terminology, 

In terminology developed in the framework of REACH implementation “substances at the nanoscale”; 
for 
see 
http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/nanomaterials_en.pdf.  Normally,  substances 
are described in their chemical identity, as defined in REACH.  
For an explanation of the term “reaction mass”, see REACH guidance on substance identification and 
naming http://guidance.echa.europa.eu/docs/guidance_document/substance_id_en.pdf, p. 21. 
Roco,  M.  C.  2004.  Nanoscale  Science  and  Engineering:  Unifying  and  Transforming  Tools.  AIChE 
Journal, 50(5): 890-897. 
Roco, M. C. 2007. National Nanotechnology Initiative– Past, Present, Future.” In Goddard, W. A., et al. 
eds.  Handbook  on  Nanoscience,  Engineering  and  Technology,  Boca  Raton,  FL,  CRC  Press;  pp.  3.1-
3.26. 
http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf, p. 12. 

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may,  however,  also  be  cases  where  the  nanomaterial  is  only  used  as  an  ingredient  for  the 
production  of  the  mentioned  applications,  during  which  the  nano-ingredient  loses  its 
particulate character (through dissolution) or its nanoscale character (through particle growth 
or fusion). 

This appendix aims to give a good and structured overview of nanomaterials on the market. It 
can,  however,  not  give  a  complete  or  exhaustive  list  of  nanomaterial  forms  or  variations 
which are often tailored in a very specific way to achieve desired properties, and which may 
also  to  a  certain  degree  have  different  toxicological  and  ecotoxicological  properties. 
Depending  on  the  concrete  cases,  these  differences  may  be  smaller  or  larger.  Therefore, 
wherever  in  this  appendix  reference  is  made  to  the  nanoform,  this  is  often  not  one  singular 
form but refers to variations in particle size, shape, surface treatment, functionalisation etc. 

In preparing this appendix, the European Commission also aimed at identifying information 
on  the  relevant  competitive  position  of  EU  companies  and  production  sites,  as  well  as  on 
market volumes for the EU. However, in general it appears that most substances are produced 
all through the industrialised world, with producers in Europe, North America (mainly United 
States  and  Canada)  and  Japan  or  other  traditionally  industrialised  countries  in  the  Far  East. 
Often there are also producers in newly industrialised countries such as China, India, Russia 
or Brazil. However, data on producers are not complete, both for the industrialised countries 
and even more so for emerging countries. Therefore, it does not seem possible to give a robust 
picture of EU companies and production sites per substance. Rather, the broad impression is 
that  most  of  the  mentioned  substances  are  produced  in  the  EU  at  a  comparable208  level  to 
other  industrialized  regions,  and  only  for  few  of  those  substances  there  seems  to  be  a 
concentration in a particular world region. For this reason, and due to a lack of specific data 
for  the  European  Union  or  Europe  as  a  whole,  reference  is  made  mainly  to  global  data. 
Equally,  most  applications  of  nanomaterials  seem 
the 
industrialized  world.  Therefore,  it  is  difficult  to  assess  whether  a  particular  application  is 
available on the EU market as opposed to other geographic regions. However, for most of the 
applications mentioned below, there is no reason to assume that they are not present in the EU 
market. 

to  be  marketed 

throughout 

All  quoted  production  volumes  are  annual  production  volumes,  unless  specified  otherwise. 
Monetary  figures  are  mostly  converted  from  US$  to  €  at  an  exchange  rate  of  0.785,  with 
appropriate rounding. 

2. 

INORGANIC NON-METALLIC NANOMATERIALS  

2.1. 

Synthetic amorphous silica (silicon dioxide, SiO2, EC Number 231-545-4) 

There  are  various  forms  of  synthetic  amorphous  silica  placed  on  the  market,  including 
precipitated  silica,  silica  gels,  colloidal  silica  or  silica  sols  and  fumed  or  pyrogenic  silica. 
Most forms are either used as stable dispersions of non-agglomerated SiO2 particles (colloidal 
silica) or as agglomerated or aggregated particles (other forms of silica).  

208 

The term “comparable” is to be understood as leaving a degree of uncertainty on the exact levels, thus it 
could not be excluded that Europe is slightly weaker in relative terms of nanomaterial uptake than e.g. 
the US or Japan. 

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45 

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Synthetic  amorphous  silica  has  been  in  use  since  the  1920ies.  According  to  SRI,  the  global 
consumption of all types of synthetic amorphous silica was around 1.5 million tons in 2010, 
with a market value of around 2.7 bn€.  

Colloidal  silicas  are  stabilised  dispersions  of  non-agglomerated,  mostly  spherical  SiO2 
particles.  The  main  uses  are  in  paper  industry  (e.g.  providing  anti-slip  properties;  retention 
aids and in coatings of ink jet paper; better handling of recycled paper); chemical-mechanical 
planarisation  (CMP)  slurries  (e.g.  polishing  agent  for  Si  wafers  used  to  produce  computer 
chips);  coatings,  paints,  inks  and  adhesives  (increasing  strength,  scratch  and  abrasion 
resistance);  precision  metal  casting  and  refractory  (e.g.  moulds  for  casting  around  wax 
originals);  food  industry  (e.g.  as  an  aid  for  clarifying  wine,  beer,  fruit  juices  etc.);  bulk 
plastics and composites; photography; metal surface treatment; catalysis; textile; leather; and 
building industry (e.g. thermal and acoustic insulation). 

Precipitated  silica  is  made  up  of  primary  particles  in  the  size  range  of  around  5-100  nm209 
which are aggregated and agglomerated in the final product. The biggest use of precipitated 
silica  is  for  the  reinforcement  of  elastomer  products,  primarily  automotive  tyres,  footwear, 
rubber  articles  and  cable  sheathing.  In  tyres,  formulations  using  precipitated  silica  reduce 
rolling  resistance,  improve  traction  under  slippery  conditions  and  improve  fuel  efficiency. 
Precipitated  silica  is  also  used  in  batteries;  as  antiblocking  agent  in  thermoplastic  films;  as 
carrier silica for liquids and semi-liquids and anti-caking agent in food powders, in health care 
products  such  as  toothpastes,  detergents  and  cosmetics;  as  matting  agents  in  paints  and 
varnishes; in the paper industry as advanced fillers in newsprint paper and in special coated 
papers  for  inkjet  and  direct  thermal  printing  to  enhance  ink  absorption;  and  in  agricultural 
products. 

Synthetic silica gels are products of the polymerisation process of fine colloidal silica. They 
have a similar structure as precipitated silica, the difference being that the cross-linked silica 
particle  networks  form  a  nanopore  structure  that  is  finer  than  the  pore  structure  of  the 
aggregated  particles  in  precipitated  silica.  Silica  gels  are  sold  in  various  types  of  gels 
(hydrogel,  aerogel,  xerogel,  etc.).  They  are  used  in  many  food  and  health  products  (e.g.  to 
selectively remove certain proteins and polyphenols that precipitate upon chilling). They are 
used in food industry as an anticaking agent and as a carrier for vitamins and as a tableting aid 
in pharmaceuticals. They are also used in cosmetics such as face powders, as flow conditioner 
and  for  oil  absorption.  Silica  gels  also  serve  as  drying  agents,  protecting  a  wide  variety  of 
products during shipment and storage. They are also used in paints, catalysts, paper coatings 
etc. 

Pyrogenic  (fumed)  silica  is  manufactured  by  using  the  high  temperature  hydrolysis  process 
developed in the beginning of the 1940s. It consists of agglomerated and aggregated primary 
particles.  The  latter  are  of  size  typically  between  5  and  100  nm.  The  aggregates,  which  are 
fused and chemically bonded primary particles, typically are of size between 100 nm and 350 
nm. The aggregates in turn form agglomerates typically in the range from 150 nm up to the 
several  100  µm.210  Pyrogenic  or  fumed  silica211  is  used  in  silicone  rubber  applications,  as  a 
reinforcement  and  thixotropic  agent  in  plastics,  gel  coats,  sealants  and  adhesives,  cosmetics 
and  toothpastes;  in  coatings  and  printing  inks;  as  a  free  flow,  antistatic  agent  in  animal 

209 
210 
211 

This can be different depending on process details. 
CEFIC, contribution received as part of the consultation on a draft version. 
To  be  distinguished  from  "silica  fume"  which  is  a  by-product  from  thermal  silicon  production 
processes, CEFIC, contribution received as part of the consultation on a draft version. 

EN 

46 

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feedstuffs  and  hygroscopic  powders;  and  carrier  for  active  ingredients.  It  is  also  used  as  an 
antifoaming  agent  in  the  manufacture  of  paper,  decaffeinated  coffee  and  tea,  poultry  and 
seafood processing, and oil refining.  

The  substance  silicon  dioxide  (synthetic  amorphous  silica)  has  been  registered  under 
REACH.212 Given the explanations in the registration dossier, referring to amorphous silica, 
fumed  and  precipitated  silica,  it  seems  however  clear  that  the  dossier  mostly,  if  not 
exclusively  relates  to  the  nanoform.  It  has  not  been  classified  as  hazardous  by  the 
registrant.213 

Animal  data  show  that  synthetic  amorphous  silica,  at  very  high  doses,  can  induce  (mostly 
reversible) inflammation, cytotoxicity and tissue damage in the lungs.214 However, treatment 
with lower doses is observed not to effect toxicity in animals.215 ECETOC has made a critical 
evaluation  of  the  physico-chemical  properties,  toxicology,  ecotoxicology  and  environmental 
fate and impact of (non-crystalline) synthetic amorphous silica.216 

In  its  opinion  of  5  June  2009,  the  EFSA  Panel  on  Food  Additives  and  Nutrient  Sources 
concluded  that  the  use  of  silicon  dioxide  up  to  1500  mg  SiO2/day  and  of  silicic  acid  gel  to 
supply up to 200 mg silicon/day, added to food supplements, is of no safety concern.217  

Synthetic  amorphous  silica  (primary  particles  in  the  size  range  1-100  nm)  needs  to  be 
distinguished  from  respirable  crystalline  silica  (primary  particles  mostly  above  100  nm). 
Contrary  to  synthetic  amorphous  silica,  crystalline  silica  is  known  to  produce  silicosis,  a 
serious chronic lung disease observed in particular with workers who have inhaled particles of 
crystalline silica.218  

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans  and  the  environment  at  the  use/consumption  and  waste  stages  varies  according  to 
application.  Exposure  to  humans  can  be  significant  when  the  amorphous  silica  is  ingested 

212 

213 

214 

215 

216

217 
218 

for 

on: 

silica; 

public 

synthetic 

available 

Synonymous 
information 
amorphous 
http://apps.echa.europa.eu/registered/data/dossiers/DISS-76fd35e0-69c4-29a3-e044-
00144f26965e/DISS-76fd35e0-69c4-29a3-e044-00144f26965e_DISS-76fd35e0-69c4-29a3-e044-
00144f26965e.html. 
Except for respiratory sensitisation and hazardous to the ozone layer (data lacking), all fields for health 
and environmental hazards indicate that the registrant considers data for those hazards as conclusive but 
not sufficient for classification. 
EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view 
For 
of 
http://nanopartikel.info/cms/lang/en/Wissensbasis/siliciumdioxid/template/element2Category2Containe
rList?catTitle=Exposure&containerID=384&queryPath=/content/jahia/dana/ContentPage_3/Wissensbas
is/siliciumdioxid/element2Category2ContainerList/ContentContainer_384; see also: Presence and risks 
of  nanosilica  in  food  products,  Dekkers,  S.;  Krystek,  P.;  Peters,  R.B.J.;  Lankveld,  D.P.K:;  Bokkers, 
B.G.H.; van Hoeven-Arentzen, P.H.; Bouwmeester, H. and Oomen A.G.; Nanotoxicology, 2010, Barly 
Online, 1-13, and comments in a letter to the editor in: Nanotoxicology, 2011; Early Online, 1–3. 

nanoparticles,  Luxembourg, 

2009.  Available 

overview 

exposure 

literature 

relevant 

see: 

at: 

an 

to 

http://www.ecetoc.org/index.php?mact=MCSoap,cntnt01,details,0&cntnt01by_category=3&cn
tnt01order_by=Reference%20Desc&cntnt01template=display_list_v2&cntnt01display_template=displa
y_details_v2&cntnt01document_id=122&cntnt01returnid=91 
http://www.efsa.europa.eu/en/efsajournal/doc/1132.pdf 
European schedule of occupational diseases (notified under document number C(2003) 3297). 

EN 

47 

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from  food,  or  in  cosmetics  and  pharmaceutical  applications.  An  important  source  of 
environmental exposure is wear of tyres.219 

2.2. 

Substances similar to synthetic amorphous silica 

There are several substances which are similar in characteristics and applications to synthetic 
amorphous  silica.  Although  they  have  not  been  widely  discussed  under  the  aspect  of 
nanomaterials,  and  hence  information  is  scarce  about  applications  of  possible  nanoforms  of 
these  substances,  they  are  likely  to  be  at  least  partly  nanomaterials  in  the  sense  of  the 
nanomaterial definition. Many of those are also produced in high volumes. Examples are salts 
of  silicic  acid  (e.g.  silicic  acid,  calcium  salt  and  silicic  acid,  aluminium  sodium  salt,  other 
amorphous  silica  products),  silica  fume  (by-product  of  thermal  silicon  production),  fused 
silica and polymerised forms of biogenic silica (e.g. from diatomae).220  

2.3. 

Titanium dioxide (TiO2, EC Number 236-675-5) 

Titanium dioxide powder exists both in bulk221 and nanoform, as well as in various crystalline 
modifications, including rutile and anatase. In its bulk form, it has been used extensively for 
about 90 years as the principal white pigment (maximum reflectivity at around a particle size 
of 300 nanometres). Titanium dioxide is also an effective UV filter. The nanoform (around 50 
nanometres)  is  transparent,  which  provides  an  esthetic  advantage  for  uses  in  sunscreens 
(mostly  rutile).  Nanoform  TiO2  in  the  anatase  modification  also  has  specific  electrical  and 
photocatalytic as well as antimicrobial properties. The nanoform of anatase is reported to be 
more reactive than the bulk form.  

The substance titanium dioxide has been registered under REACH.222 According to industry, 
the registration covers all forms of titanium dioxide including the bulk and the nanoform but 
with  no  specific  differentiation.  The  substance  has  not  been  classified  as  hazardous  by  the 
registrant.223  

Results  from  experimental  animal  studies  show  inflammogenic,  oxidative  and  genotoxic 
pulmonary  responses  at  high  doses.  Chronic  exposure  also  has  the  potential  to  promote 
tumour  development.224,225  There  is  also  one  study  showing  genotoxic  responses  after  oral 
administration in animal studies.226 

219 
220 

221 

222 

223 

224 

225 
226 

the 

the  use  of 

term  “bulk”,  see  Nanomaterials 

As part of the rubber matrix. 
Information from contributions to the CASG(Nano) consultation and joint work between ECHA and the 
Commission services analysing a number of registration dossiers in more detail. 
For  an  explanation  of 
http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/nanomaterials_en.pdf. 
Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eaff323-
014a-482f-e044-00144f67d031/DISS-9eaff323-014a-482f-e044-00144f67d031_DISS-9eaff323-014a-
482f-e044-00144f67d031.html. 
Except for hazardous to the ozone layer (data lacking), all fields indicate that the registrant considers 
data for all endpoints as conclusive but not sufficient for classification. 
Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report, p. 141. 
http://www.cdc.gov/niosh/docs/2011-160/pdfs/2011-160.pdf 
Titanium  Dioxide  Nanoparticles  Induce  DNA  Damage  and  Genetic  Instability  In  vivo  in  Mice, 
Trouiller, B., Reliene, R., Westbrook, A., Solaimani, P., Schiestl, R.H., Cancer Res November 15, 2009 
69; 8784. Available at http://cancerres.aacrjournals.org/content/69/22/8784.full. 

-  Review  of  Health  and  Environmental  Safety 

in  REACH,  p.5, 

(ENRHES), 

EN 

48 

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Titanium  dioxide  has  been  in  2006  classified  by  the  International  Agency  for  Research  on 
Cancer  (IARC)  as  an  IARC  Group  2B  carcinogen  ''possibly  carcinogen  to  humans.227  US 
NIOSH recommended a lower exposure limit for ultrafine particles of titanium dioxide228: 0.3 
mg/m3  for  TiO2  nanoparticles  (<100  nm),  versus  2.4  mg/m3  for  fine  particles  (>100nm), 
based  on  the  particle  surface  reactivity.  Although  it  is  established  that  TiO2  does  not  pass 
undamaged  skin,  there  is  an  ongoing  scientific  debate  on  whether  and  to  what  degree  TiO2 
nanoparticles  can  penetrate  damaged  skin.  The  approval  for  use  of  TiO2  as  a  UV  filter  in 
sunscreens is currently being updated by SCCS. 

According to SRI, the global market for nanoform TiO2 is estimated to be about 10 thousand 
tonnes per year. The Commission has also received estimates which are higher than this but 
still in the same rough order of magnitude. Around 5 thousand tonnes per year are used in the 
personal care industry, of which around 430 tonnes in sunscreens. Next to sunscreens, the UV 
filtering  properties  are  also  used  in  coatings  for  plastics  and  metals,  varnishes  for  wood 
preservation,  in  textile  fibres  and  in  packaging  films.  Another  main  use  is  catalysts  (e.g. 
decomposing  NOx  into  nitrates  or  N2).  The  photocatalytic  and  antimicrobial  properties  are 
used in 'self-cleaning' products (e.g. windows, cement, tiles, textiles for use in hospitals) and 
air purification systems. Use in tribological coatings prevent deposits in engines and enhance 
fuel efficiency. TiO2 nanoparticles are also used to increase scratch-resistance of coatings and 
in the production of electronic components and dental impressions. TiO2 can also be used in 
dye-sensitized  solar  cells  to  produce  electricity,  though  efficiency  is  currently  lower  than 
traditional silicon solar cells.  

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans and the environment at the use stage varies according to application. It can be high, in 
particular  in  cosmetics  applications.  In  other  applications  where  the  nanoparticles  are 
embedded  in  a  matrix  or  used  in  closed  systems,  it  is  estimated  to  be  low,  especially  if 
referring  to  short-term  exposure.  There  are  ongoing  discussions  whether  leaching  (e.g.  of 
outdoor paints or release at the waste stage) could lead to exposure to significant amounts of 
nanoparticles.229 

2.4. 

Zinc oxide (ZnO, EC Number 215-222-5) 

Like  titanium  dioxide,  zinc  oxide  powder  exists  in  bulk  and  in  nanoform.  Its  nanoform  is 
colourless and an effective UV-filter with a different spectrum than titanium dioxide. It also 
has antimicrobial properties (though less strong than TiO2) and can be used as an active agent 
in self-cleaning products. 

227 

228 

229 

as 

an 

2B 

''possibly 

carcinogen 

carcinogen 

IARC  Group 

Titanium  dioxide  has  been  in  2006  classified  by  the  International  Agency  for  Research  on  Cancer 
humans; 
(IARC) 
http://monographs.iarc.fr/ENG/Monographs/PDFs/93-titaniumdioxide.pdf. 
Occupational Exposure to Titanium Dioxide, Current Intelligence Bulletin 63: Occupational Exposure 
to  Titanium  Dioxide,  National  Institute  for  Occupational  Safety  and  Health  2011.  Available  at 
http://www.cdc.gov/niosh/docs/2011-160/; 
also: 
http://nanopartikel.info/cms/lang/en/Wissensbasis/Titandioxid/template/element2Category2ContainerLi
st?catTitle=Exposure&containerID=46&queryPath=/content/jahia/dana/ContentPage_3/Wissensbasis/T
itandioxid/element2Category2ContainerList/ContentContainer_46. 
For 
see : 
further 
http://nanopartikel.info/cms/lang/en/Wissensbasis/Titandioxid/template/element2Category2ContainerLi
st?catTitle=Exposure&containerID=46&queryPath=/content/jahia/dana/ContentPage_3/Wissensbasis/T
itandioxid/element2Category2ContainerList/ContentContainer_46, section on environmental exposure. 

information 

literature 

further 

see 

to 

EN 

49 

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The substance zinc oxide has been registered under REACH.230 However, the registration is 
unspecific to the nanoform (although certain references could be interpreted as referring to the 
nanoform). It has been classified as hazardous (Aquatic Chronic 1) with the following Hazard 
Statement (GHS): H410: Very toxic to aquatic life with long lasting effects.231  

SCCS currently assesses ZnO UV filters.  

Like  the  bulk  form  of  ZnO,  ZnO  nanoparticles  show  a  relatively  high  toxicity  for  cells  of 
different tissues and different organisms in in-vitro studies. For most cell types, the relevant 
value is in the range of 10-20 µg/ml. There are limited in-vivo studies on ZnO nanoparticles 
indicating severe but temporary pulmonary inflammatory responses. The effects for nanoscale 
and  fine  particles  seem  to  be  very  similar.  Zinc  oxide  fine  particles  (e.g.  from  zinc  oxide 
fume, e.g. in welding) can cause metal fume fever.232,233 

According to SRI, the global market for nanoform zinc oxide is several thousand tonnes per 
year. Major uses are as a UV-filter in cosmetics (where it competes with bulk zinc oxide but 
has the advantage of being transparent), in varnishes (as a UV-filter and self-cleaning agent), 
ceramics and electronics. Nanoform zinc oxide is also used in rubber, improving toughness, 
increasing  abrasion  resistance  (e.g.  reducing  wear  loss  in  tyres)  and  preventing  UV  and 
bacterial  degradation.  In  this  way,  the  life  time  of  rubber  products  can  be  prolonged.  An 
emerging  use  is  zinc  oxide  nanowires  for  UV  nanolasers.  Uses  are  also  reported  in  liquid 
crystal displays and solar cells.234 

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans and the environment at the use stage varies according to application but can be high 
in  particular  in  cosmetics.  Another  source  of  environmental  exposure  is  wear  of  tyres235. 
There  are  ongoing  discussions  whether  release  at  the  waste  stage  could  lead  to  exposure  to 
significant amounts of nanoparticles. 

2.5. 

Aluminium oxide (Al2O3, EC Number 215-691-6) 

Aluminum oxide nanoparticles are widely used as fillers in polymers and tyres and to increase 
scratch- and abrasion-resistance in coatings. 

230 

231 

232 

233

234 
235 

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb185b3-
df52-333c-e044-00144f67d031/AGGR-fbd39734-7544-4e5a-8f87-2e1d877da115_DISS-9eb185b3-
df52-333c-e044-00144f67d031.html. 
Except  for  the  classification  as  Aquatic  Chronic  1H410:  Very  toxic  to  aquatic  life  with  long  lasting 
effects, and for hazardous to the aquatic environment (acute/short-term) (data lacking), all other fields 
indicate  that  the  registrant  considers  data  for  all  other  endpoints  as  conclusive  but  not  sufficient  for 
classification.  
Zinc  oxide,  Registry  of  Toxic  Effects  of  Chemical  Substances  RTECS  #:  ZH4810000, 
http://www.cdc.gov/niosh-rtecs/ZH496510.html#P;  NIOSH  Pocket  Guide  to  Chemical  Hazards, 
http://www.cdc.gov/niosh/npg/npgd0675.html. 

http://nanopartikel.info/cms/lang/en/Wissensbasis/Zinkoxid/template/element2Category2Conta
inerList?catTitle=Exposure&containerID=528&queryPath=/content/jahia/dana/ContentPage_3/Wissens
basis/Zinkoxid/element2Category2ContainerList/ContentContainer_528 
Observatory Nano – http://www.observatorynano.eu/project/document/79/. 
As part of the rubber matrix. 

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The  substance  aluminium  oxide  has  been  registered  under  REACH236.  However,  the 
registration is unspecific to the nanoform (although certain references could be interpreted as 
referring to the nanoform). It has not been classified as hazardous.237  

Aluminium  oxide  nanoparticles  show  a  low  level  of  toxicity,  although  pulmonary 
inflammatory responses can be observed at very high doses.238  

According  to  SRI,  the  global  market  for  nanoform  alumina  powders  is  estimated  at  200 
thousand tonnes, representing a market value of €750 million. Nanoform Al2O3 powders and 
dispersions are used inter alia in scratch- and abrasion resistant coatings (e.g. for cutting and 
grinding tools, automobile exteriors, safety glasses and scratch-resistant windows for barcode 
scanners, flooring), as abrasive particles in slurries for polishing semiconductor and precision 
optical components, in the coating of light bulbs and fluorescent tubes, as a flame retardant, as 
fillers for polymers and tyres, in coatings of high-quality inkjet papers, in catalysts including 
the support structure in automobile catalytic converters, in refractory materials and as ceramic 
filtration membranes. Nanoform alumina can also be used for the manufacture of transparent 
ceramic bodies for high-pressure lamps.  

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans and the environment at the use stage is estimated to be rather low as the aluminium 
oxide is mostly embedded in a matrix and most applications do not seem to imply an intended 
release. However, there could be some exposure e.g. through wear of tools or tyres. There are 
ongoing discussions whether release at the waste stage could lead to exposure to significant 
amounts of nanoparticles. 

2.6. 

Aluminium hydroxides and aluminium oxo-hydroxides 

There are also different aluminium hydroxide (e.g. bayerite and gibbsite) and aluminium oxo-
hydroxide (e.g. boehmite and diaspore) particles in nanoform. Aluminum hydroxide Al(OH)3 
in  powder  form  is  used  as  a  flame  retardant  and  as  filler  in  carpets,  rubbers,  plastics,  and 
foamed plastics. Moreover, it is used in toothpaste and cosmetics. Aluminum (hydr)oxides are 
often used in the dye and plastics industries as thickeners and fillers and as agents that reduce 
adhesiveness  and  increase  scratch  resistance.  Besides,  they  serve  to  enhance  the  color 
saturation of paints and varnishes.239 

236 

237 

238

239 

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb4460f-
9f3a-575c-e044-00144f67d031/DISS-9eb4460f-9f3a-575c-e044-00144f67d031_DISS-9eb4460f-9f3a-
575c-e044-00144f67d031.html; 
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eaed058-
ddea-203e-e044-00144f67d031/DISS-9eaed058-ddea-203e-e044-00144f67d031_DISS-9eaed058-ddea-
203e-e044-00144f67d031.html. 
All fields indicate that the registrant considers data for all endpoints as conclusive but not sufficient for 
classification. 

http://nanopartikel.info/cms/lang/en/Wissensbasis/Aluminiumoxide/template/element2Categor
y2ContainerList?catTitle=Exposure&containerID=534&queryPath=/content/jahia/dana/ContentPage_3/
Wissensbasis/Aluminiumoxide/element2Category2ContainerList/ContentContainer_534 
http://nanopartikel.info/cms/lang/en/Wissensbasis/Aluminiumoxide 

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2.7. 

Iron oxides: Diiron trioxide (ferric oxide, hematite, Fe2O3, EC Number 215-168-
2)  and  triiron  tetraoxide  (ferrous-ferric  oxide,  magnetite,  Fe3O4,  EC  Number 
215-277-5) 

There are several types of nanoform iron oxides. According to SRI, the most common ones 
are nanoform hematite (ferric oxide or Fe2O3) and nanoform magnetite (ferrous-ferric oxide 
or Fe3O4).  

The substance diiron trioxide has been registered under REACH.240 However, the registration 
is unspecific to the nanoform (although certain references could be interpreted as referring to 
the nanoform). It has not been classified as hazardous.241 The substance triiron tetraoxide has 
been  registered  under  REACH.242  However,  the  registration  is  unspecific  to  the  nanoform 
(although  certain  references  could  be  interpreted  as  referring  to  the  nanoform).  It  has  been 
partly classified as hazardous with the following hazard statement (GHS): H251: Self-heating: 
may catch fire.243 

Iron  oxide  nanoparticles  show  a  low  level  of  toxicity,  although  production  of  inflammatory 
factors observed in some studies.244 

According to SRI, industry sources believe that the global market for iron oxide nanoparticles 
is currently about €20-40 million, which should correspond to roughly 100 tonnes. This value 
should however be taken with caution because it is difficult to distinguish between bulk and 
nanoform  applications  of  iron  oxides.  Nanoform  ferric  oxide  particles  are  used  in  pigment 
applications (e.g. in automotive industry or in cosmetics) offering clean shades of a number of 
colours  but  with  high  transparency  while  still  offering  protection  from  UV  light.  Magnetite 
particles have been used for a long time for data storage in magnetic tapes, hard drives etc. 
There is a trend to use smaller particles including nanoparticles for these uses. Another use of 
magnetite  nanoparticles  is  ferrofluids,  which  are  stable  colloidal  suspensions  of  magnetic 
nanoparticles  in  a  liquid  carrier.  Ferrofluids  are  used  e.g.  in  electronic  components  like 
loudspeakers  and  hard  disks  (preventing  dirt  particles  from  entering  the  hard  drive),  or  in 
shock  absorbers  in  the  automotive  industry.  Other  emerging  applications  of  nanoform  iron 
oxide particles are in medicine. After selectively attaching nanoparticles to tumour cells, those 
cells can selectively be destroyed by applying electromagnetic energy. Drugs and diagnostic 
agents  attached  to  magnetic  nanoparticles  could  selectively  be  transported  to  targets  in  the 
body. Other uses of iron oxide nanoparticles include polishing media, catalysts, components 

240 

241 

242 

243 

244

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb9b2bd-
9dfd-0981-e044-00144f67d031/DISS-9eb9b2bd-9dfd-0981-e044-00144f67d031_DISS-9eb9b2bd-9dfd-
0981-e044-00144f67d031.html. 
Except for: Acute toxicity – dermal; Acute toxicity – inhalation; Respiratory sensitization; Aspiration 
hazard;  Reproductive  toxicity;  Effects  via  lactation  (data  lacking),  all  other  fields  indicate  that  the 
registrant considers data for all other endpoints as conclusive but not sufficient for classification. 
Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ea4fafe-
9d48-4fe0-e044-00144f67d031/DISS-9ea4fafe-9d48-4fe0-e044-00144f67d031_DISS-9ea4fafe-9d48-
4fe0-e044-00144f67d031.html. 
Except  for  the  classification as  self  heating  and  except  for:  Acute  toxicity  –  dermal;  Acute  toxicity  – 
inhalation;  Respiratory  sensitization;  Aspiration  hazard;  Reproductive  toxicity;  Effects  via  lactation 
(data  lacking),  all  other  fields  indicate  that  the  registrant  considers  data  for  all  other  endpoints  as 
conclusive but not sufficient for classification. 

http://nanopartikel.info/cms/lang/en/Wissensbasis/Eisen/template/element2Category2Containe
rList?catTitle=Exposure&containerID=396&queryPath=/content/jahia/dana/ContentPage_3/Wissensbas
is/Eisen/element2Category2ContainerList/ContentContainer_396 

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in fuel cells, oxygen sensors, ceramics and optoelectronic devices, and soil and groundwater 
remediation and water treatment. 

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Except  in 
medical applications and cosmetics, exposure to humans and the environment at the use stage 
is estimated to be rather low as the iron oxide is mostly embedded in a matrix and applications 
do not seem to imply an intended release. There are ongoing discussions whether release at 
the  waste  stage  could  lead  to  exposure  to  significant  amounts  of  nanoparticles.  Specific 
exposure  could  also  arise  in  applications  for  soil  and  groundwater  remediation  as  well  as 
water treatment. 

2.8. 

Cerium dioxide (CeO2, EC-Number 215-150-4) 

Ceria (CeO2) is a rare-earth oxide with specific optical properties.  

The  substance  cerium  dioxide  has  been  registered  under  REACH.245  The  registrant  has 
indicated  that  the  substance  has  a  nanoform  and  has  provided  separate  information  on  the 
nanoform. Neither form has been classified as hazardous.246  

Inflammatory responses to cerium dioxide nanoparticles at high doses have been observed in-
vitro for certain cell lines, though not for others.247 

films  are  used 

According to SRI, the global market for nanoform cerium oxide is around 10 thousand tonnes. 
in  optical,  electro-optical, 
Nanostructured  CeO2-x 
microelectronic  and  optoelectronic  devices.  Nanoform  ceria  is  used  inter  alia  as  a  polishing 
material for glass surfaces and silicon wafers, to finish photomasks and disk drives, as an anti-
corrosion material, e.g. in exterior architectural paint, steel and other metal plates, and in fuel 
cells. Another major application is as a catalytic diesel fuel additive, decreasing toxic diesel 
emissions and increasing fuel efficiency. 

in  applications 

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Except  in 
applications  as  a  fuel  additive,  exposure  to  humans  and  the  environment  at  the  use  stage  is 
estimated to be rather low. There are ongoing discussions whether release at the waste stage 
could lead to exposure to significant amounts of nanoparticles. 

245 

246 

247

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-a217355e-
db00-127d-e044-00144f67d031/DISS-a217355e-db00-127d-e044-00144f67d031_DISS-a217355e-
db00-127d-e044-00144f67d031.html. 
Bulk  form:  Except  for:  Respiratory  sensitization;  Aspiration  hazard;  Effects  via 
lactation; 
carcinogenicity; hazardous to the ozone layer (data lacking), all other fields indicate that the registrant 
considers  data  for  all  other  endpoints  as  conclusive  but  not  sufficient  for  classification;  Nanoform: 
except for:  Skin  corrosion  /  irritation;  Germ  cell  mutagenicity;  Hazardous  to  the  aquatic  environment 
(both  acute/short-term  and  long-term)  (conclusive  but  not  sufficient  for  classification),  the  registrant 
indicates that data for all other endpoints are lacking. 

http://nanopartikel.info/cms/lang/en/Wissensbasis/Cerdioxid/template/element2Category2Cont
ainerList?catTitle=Exposure&containerID=67&queryPath=/content/jahia/dana/ContentPage_3/Wissens
basis/Cerdioxid/element2Category2ContainerList/ContentContainer_67 

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2.9. 

Zirconium dioxide (ZrO2, EC-Number 215-227-2) 

Ceramic  materials  made  by  sintering  nanoform  zirconia  (ZrO2)  powder  have  a  number  of 
unique properties, including some forms with very high fracture toughness. 

The  substance  zirconium  dioxide  has  been  registered  under  REACH.248  However,  the 
registration is unspecific to the nanoform. It has not been classified as hazardous.249 

In vitro tests showed stress on human lung epithelial cells at high doses.250 

According to SRI, total consumption of nanoform zirconium dioxide is estimated to be in the 
range of 2,500-3,000 tonnes. The largest application, with about 50% is in optical connectors, 
followed  by  fuel  cells,  lithium-ion  batteries,  catalysts  and  ceramic  membranes.  Other 
developing  applications  are  in  structural  and  electronic  ceramics,  dental  fillings,  prostheses, 
fluorescent lighting and as polishing agent. 

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans and the environment at the use stage is estimated to be low, as in most applications it 
is fixed in a matrix. An exception is the application in biomedical implants, where wear can 
lead to the generation of nanoscale debris. One of the advantages of ceramic implants is the 
lower release of wear debris as compared to polymer or metal components. There are ongoing 
discussions whether release at the waste stage could lead to exposure to significant amounts 
of nanoparticles. 

2.10.  Other oxide nanomaterials 

Other oxide nanomaterials on the market include barium titanate, barium sulphate, strontium 
titanate, strontium carbonate, indium tin oxide (ITO) and antimony tin oxide (ATO). Barium 
titanate  powders  are  the  dominating  raw  material  for  the  production  of  ceramic  dielectric 
layers  in  low-temperature  multilayer  ceramic  capacitors  (MLCC).  According  to  SRI,  it  is 
marketed in annual quantities of 15000 tonnes globally. Indium tin oxide is a semi-conducting 
material  used  as  thin-film  material  for  the  production  of  transparent  electrodes  in  liquid 
crystal  displays,  touch  screens,  organic  LEDs,  thin-film  solar  cells,  semiconducting  sensors 
etc.  Due  to  its  IR-radiation  reflectivity  it  is  often  used  as  thermal  insulation  coating  on 
window  glass.  Its  anti-static  properties  make  it  additionally  suitable  e.  g.  for  packing  and 
storage of sensitive electronic components. However, as ITO-prices have drastically increased 
due to a global indium production shortage within the last years, research for alternatives has 
intensified.  Antimony  tin  oxides  have  similar  IR-radiation  reflectivity  properties.  Among 
these  materials,  only  the  substances  barium  sulphate  and  strontium  carbonate  have  been 

248 

249 

250

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-97d7012e-
917c-6fad-e044-00144f67d031/DISS-97d7012e-917c-6fad-e044-00144f67d031_DISS-97d7012e-917c-
6fad-e044-00144f67d031.html. 
Except for: Acute toxicity – dermal; Respiratory sensitization; Aspiration hazard; Effects via lactation; 
carcinogenicity; hazardous to the ozone layer (data lacking), all other fields indicate that the registrant 
considers data for all other endpoints as conclusive but not sufficient for classification. 

http://nanopartikel.info/cms/lang/en/Wissensbasis/Zirkoniumdioxid/template/element2Categor
y2ContainerList?catTitle=Exposure&containerID=591&queryPath=/content/jahia/dana/ContentPage_3/
Wissensbasis/Zirkoniumdioxid/element2Category2ContainerList/ContentContainer_591 

EN 

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registered under REACH (both unspecific to nanomaterials).251 They have not been classified 
as hazardous.252 There are also other similar oxides but less information is available to what 
degree these oxides are already on the market.  

For  further  oxides  which  have  been  registered  under  REACH,  there  is  information  that 
nanoforms exist, and certain information in the registration dossier could be interpreted as referring 
to the nanoform. These substances include253 dibismuth trioxide, nickel monooxide and disilver 
oxide.  

There is also information on the existence of other nanoforms of oxides, e.g. a wide range of 
rare earth oxides. Most of those substances, if at all, are marketed only at smaller scale. 

2.11.  Calcium Carbonate (CaCO3, EC-Number 207-439-9) 

Most of the fine-ground calcium carbonate is generally in a particle size above 100 nm. There 
are however also nanoforms of this material, although it is difficult to get a full picture of the 
use of the nanoform. It seems that ultrafine calcium carbonate is used as an advanced filler in 
sealants and in plastic for window frames.254 Fine-ground calcium carbonates are widely used 
as fillers in paper, plastics, paints and coatings, and adhesive and sealants. They are also used 
as a food additive (E 170). In the latter cases, most of the material used seems however to be 
in a particle size above 100 nm. 

The  substance  calcium  carbonate  has  been  registered  under  REACH.255  The  registrant  has 
indicated  that  the  substance  has  a  nanoform  and  has  provided  separate  information  on  the 
nanoform. Calcium carbonate, including its nanoform, has not been classified as hazardous.256 
EFSA has recently given a scientific opinion on re-evaluation of calcium carbonate (E 170) as 
a food additive.257 This opinion, concluded that “the available data are sufficient to conclude 
that  the  current  levels  of  adventitious  nanoscale  material  within  macroscale  calcium 
carbonate would not be an additional toxicological concern".258 

251 

252 

253 

254 

255 

256 

257 
258 

http://apps.echa.europa.eu/registered/data/dossiers/DISS-

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-97d78296-
bd48-13fd-e044-00144f67d031/DISS-97d78296-bd48-13fd-e044-00144f67d031_DISS-97d78296-
bd48-13fd-e044-00144f67d031.html; 
9876be4a-cbe0-274b-e044-00144f67d031/DISS-9876be4a-cbe0-274b-e044-00144f67d031_DISS-
9876be4a-cbe0-274b-e044-00144f67d031.html. 
For both substances, all fields indicate that the registrant considers data for all endpoints as conclusive 
but not sufficient for classification. 
This list is not exhaustive. In addition, there are also reaction masses between different oxides, which 
are not listed here. 
http://www.observatorynano.eu/project/filesystem/files/Construction%20-
%20Adhesive%20%20Sealants%20-%202010.pdf 
Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-97d91307-
32ca-6360-e044-00144f67d031/DISS-97d91307-32ca-6360-e044-00144f67d031_DISS-97d91307-
32ca-6360-e044-00144f67d031.html. 
Both bulk and nanoform: Except for: Respiratory sensitization; Aspiration hazard; Effects via lactation 
(data  lacking),  all  other  fields  indicate  that  the  registrant  considers  data  for  all  other  endpoints  as 
conclusive but not sufficient for classification. 
http://www.efsa.europa.eu/en/efsajournal/pub/2318.htm 
The share of particles with a size less than 100 nm in food grade calcium carbonate is estimated at less 
than 1%. 

EN 

55 

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2.12.  Other non-oxide inorganic non-metallic nanomaterials 

Substances  in  this  category  which  have  nanomaterial  forms  include  e.g.  aluminium  nitride, 
silicon  nitride,  titanium  nitride,  titanium  carbonitride,  tungsten  carbide,  tungsten  sulphide. 
Among  those  substances,  only  the  substance  tungsten  carbide  has  been  registered  under 
REACH.259 However, the registration is unspecific to the nanoform. It has not been classified 
as hazardous.260 Aluminium nitride is used in the electronic industry in various particle sizes, 
including  nanoparticles.  Titanium  nitride  powders  with  a  particle  size  from  nano-  to 
micrometers  are  used  as  additive  in  the  production  of  wear-resistant  sintered  materials. 
Furthermore  it  is  added  to  plastics,  particularly  to  PET.  TiN  nanoparticles  improve  the 
thermal  properties  of  the  material  and  allow  increasing  the  production  output  of  PET 
bottles.261  The  nanoform  has  been  assessed  by  EFSA262  and  authorised  as  a  food  contact 
material.263  In  vitro  tests  show  cytotoxic  effects  at  high  doses.264  Tungsten  carbide  is  used 
mainly for hardening the surfaces of cutting tools to improve wear and temperature resistance. 
Tungsten carbide nanoparticles are at the barrier to large-scale production. Tungsten sulphide 
seems to be a promising lubricant for harsh conditions.  

3. 

METALS AND METAL ALLOYS

265 

3.1. 

Gold (Au, EC-Number 231-165-9) 

According to SRI, the global production of colloidal gold dispersions in 2010 corresponded to 
an  equivalent  to  3.5  kilograms  of  gold.  Gold  nanoparticles  are  mostly  used  in  medical 
applications, in particular in in-vitro-diagnostics. Other applications include catalysts, optics, 
solar cells, inks for printable electronics, sensors and surface coatings. 

Among  the  few  available  studies,  results  on  toxicity  of  gold  nanoparticles  seem  to  be 
somewhat contradictory but there are indications of inflammatory responses (in particular for 
smaller  particle  sizes).  Gold  nanoparticles  can  become  systematically  available  following 
exposure and tend to accumulate in the liver (but to an extent also other organs).266 

259 

260 

261 
262 
263 

264

265 
266 

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ea8a704-
db22-007b-e044-00144f67d031/DISS-9ea8a704-db22-007b-e044-00144f67d031_DISS-9ea8a704-
db22-007b-e044-00144f67d031.html. 
Except  for:  Respiratory  sensitization;  Effects  via  lactation;  Carcinogenicity  (data  lacking),  all  other 
fields indicate that the registrant considers data for all other endpoints as conclusive but not sufficient 
for classification. 
http://nanopartikel.info/cms/lang/en/Wissensbasis/Titannitrid 
http://www.efsa.europa.eu/en/efsajournal/pub/888.htm 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF; 
scientific opinion, see: http://www.efsa.europa.eu/en/scdocs/doc/cef_op_ej888-890_21stlist_en,3.pdf 

for 

http://nanopartikel.info/cms/lang/en/Wissensbasis/Titannitrid/template/element2Category2Con
tainerList?catTitle=Exposure&containerID=768&queryPath=/content/jahia/dana/ContentPage_3/Wisse
nsbasis/Titannitrid/element2Category2ContainerList/ContentContainer_768 
Note that alloys are not substances but special mixtures for the purpose of REACH.  
(ENRHES), 
Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report, 
354; 
http://nanopartikel.info/cms/lang/en/Wissensbasis/gold/template/element2Category2ContainerList?catT
itle=Exposure&containerID=692&queryPath=/content/jahia/dana/ContentPage_3/Wissensbasis/gold/ele
ment2Category2ContainerList/ContentContainer_692. 

-  Review  of  Health  and  Environmental  Safety 

p. 

EN 

56 

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Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans  and  the  environment  at  the  use  stage  can  be  substantial  in  certain  biomedical 
applications. In most others, it is estimated to be relatively low because the nanoparticles are 
bound  in  a  matrix.  There  are  ongoing  discussions  whether  release  at  the  waste  stage  could 
lead to exposure to significant amounts of nanoparticles. 

3.2. 

Silver (Ag, EC-Number 231-131-3) 

Nanosized silver was first produced in 1880. It was used for a long time in photographic film 
applications.  Today,  it  is  mostly  used  in  antimicrobial  applications  where  a  high  release  of 
silver ions is needed (in other applications, bulk silver or silver salts are used).  

The substance silver has been registered under REACH.267 Despite a number of references to 
tests relating to nanoforms, there is an explicit statement that the nanoform is not covered by 
the dossier. Silver powder has been classified as hazardous (Aquatic Chronic 1 and Aquatic 
Acute 1) with the following Hazard Statements (GHS): H410: Very toxic to aquatic life with 
long lasting effects and H400: Very toxic to aquatic life.268 

Silver  nanoparticles  show  various  adverse  health  effects  at  high  doses.  At  very  high  doses, 
they  can  provoke  pulmonary  oedemas  and  brown  stains  in  skin  and  body  organs  (argyria). 
There  are  indications  that  silver  nanoparticles  can  penetrate  skin,  become  systematically 
available following exposure and tend to accumulate in the liver (but to an extent also other 
organs).269  Silver  is  known  as  a  highly  ecotoxic  metal,  in  particular  for  the  aquatic 
environment. This seems to be linked to the toxicity of the silver ion. However, there are also 
studies which show higher effects from silver nanoparticles than what might be expected from 
the  presence  of  ions  alone.270  There  are  also  concerns  on  the  possible  development  of 
antimicrobial resistance due to increased use of nanosilver, as well as possible adverse effects 
on  waste  water  treatment  processes.  The  Commission  has  recently  issued  a  mandate  to 
SCENIHR  to  assess  safety,  health  and  environmental  effects  of  nanosilver  and  its  role  in 
antimicrobial resistance.271 

According to SRI, the global market for nanoform silver in antimicrobial uses is estimated at 
22 tonnes (around 10% of total use of silver for antimicrobial use). Antimicrobial uses of nanoform 
silver include anti-microbial textiles for hospitals, wound plasters, and anti-odour sportswear, 
bed  mattresses,  socks  or  underwear.  There  are  also  reported  uses  in  toys,  household 
appliances  such  as  refrigerators  and  washing  machines,  cosmetics,  containers  for  contact 

267 

268 

269 

270 

271 

Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d92ea78-
89c7-2334-e044-00144f67d249/DISS-9d92ea78-89c7-2334-e044-00144f67d249_DISS-9d92ea78-
89c7-2334-e044-00144f67d249.html. 
Except  for  the  classification  as  Aquatic  Chronic  1  H410:  Very  toxic  to  aquatic  life  with  long  lasting 
effects and except for: Reproductive toxicity; Effects via lactation, Carcinogenicity; Hazardous to the 
aquatic  environment  (acute/short-term)  (data  lacking),  all  other  fields  indicate  that  the  registrant 
considers data for all other endpoints as conclusive but not sufficient for classification. 
Engineered  Nanoparticles 
(ENRHES), 
354; 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report. 
http://nanopartikel.info/cms/lang/en/Wissensbasis/Silber/template/element2Category2ContainerList?cat
Title=Exposure&containerID=192&queryPath=/content/jahia/dana/ContentPage_3/Wissensbasis/Silber
/element2Category2ContainerList/ContentContainer_192. 
Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report, p. 358. 
http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_q_027.pdf 

-  Review  of  Health  and  Environmental  Safety 

-  Review  of  Health  and  Environmental  Safety 

(ENRHES), 

p. 

EN 

57 

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lenses, etc. A much lower amount (in the range of 200 kg) went into non-textile antimicrobial 
coatings. Other uses of nanoform silver in small quantities include inks for inkjet printers and 
printable electronics, catalysts, photovoltaics, displays and fuel cells. 

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans and the environment at the use stage can be significant for antimicrobial applications. 
For  other  applications,  it  is  considered  to  be  low  because  it  is  bound  in  a  matrix.  There  are 
ongoing discussions whether release at the waste stage could lead to exposure to significant 
amounts of nanoparticles. 

3.3. 

Other metallic nanoparticles 

Platinum  and  palladium  alloy  nanoparticles  are  mostly  used  in  electronics  (production  of 
multi-layer ceramic capacitors). According to SRI, quantities reported are in the range of 12 
tonnes  annually  (including  sizes  above  100  nm).  Other  uses  include  catalysis  (including 
combustion exhaust purification) and energy technologies. Uses in data storage and medical 
applications are being discussed. 

Copper nanopowders (though mostly in sizes above 100 nm) are used in electronics and, to 
a small degree, in inks. Copper nanoparticles are highly toxic to the aquatic environment.272 

Iron  nanoparticles  are  mostly  used  in  magnetic  recording  tapes  (needle  shaped  ferrite 
particles), though this use is declining. 

Titanium nanoparticles are increasingly used as an alloy compound in lightweight materials 
within  the  aerospace  and  increasingly  the  automotive  sector,  and  as  a  material  for  medical 
implants.273 

There are also other metal nanoparticles (e.g. nickel, cobalt, aluminium, zinc, manganese, 
molybdenum, tungsten, lanthanum, lithium) used in smaller quantities, e.g. in electronics, 
though  it  is  not  always  clear  to  what  degree  the  particles  are  below  100  nm.  Rhodium 
nanoparticles are reported to be used in catalysts.274 

4. 

CARBON-BASED NANOMATERIALS 

4.1. 

Fullerenes 

Fullerenes  are  molecules  consisting  of  an  even  number  of  60  or  more  carbon  atoms,  which 
form  a  cage-like  fused-ring  polycyclic  system  with  12  5-membered  rings  and  the  rest  6-
membered  rings  (see  http://cdb.iso.org).  The  simplest  molecule  with  60  carbon  atoms  is 
spherical with a diameter of around 0.71 nm.275  

272 

273 

274 
275 

EN 

Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report. p. 358. 
ObservatoryNano 
http://www.observatorynano.eu/project/document/66/ 
http://www.rivm.nl/bibliotheek/rapporten/340370001.pdf, p. 22. 
Nucleus to nucleus in a crystalline structure of C60 molecules. 

-  Review  of  Health  and  Environmental  Safety 

(ENRHES), 

http://www.observatorynano.eu/project/document/63/; 

58 

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The  studies  conducted  so  far  suggest  oxidant  driven  responses  in  the  lungs  (inflammation, 
cytotoxicity  and  tissue  damage).  There  are  limited  ecotoxicological  studies  which  indicate 
possible  aquatic  toxicity.  However,  some  of  the  results  may  also  be  due  to  the  solvents 
used.276 

Despite substantial research and development activities, the current market for fullerenes and 
derivatives is supposed to be relatively small, including additives for polymers used in sports 
equipment  such  as  tennis  rackets  and  golf  balls (strength), cosmetics (dark color, anti-aging 
skin creams), in fuel cells, lithium battery anodes, solar cells component, protective eyewear 
etc. There is also significant research, e.g. into medical applications. 

Workplace exposure can occur at production, use, when machining materials and from waste 
and  depends  on  the  work  procedure  and  applied  risk  management  measures.  Exposure  to 
humans and the environment at the use stage can be significant in particular for cosmetics and 
biomedical applications. For other applications, it is considered to be low because it is bound 
in  a  matrix.  There  are  ongoing  discussions  whether  release  at  the  waste  stage  could  lead  to 
exposure to significant amounts of nanoparticles.  

4.2. 

Carbon nanotubes and carbon nanofibers277 

Carbon  nanotubes  are  tubes  consisting  of  one  or  more  concentric  sheets  of  carbon  atoms 
arranged  in  the  same  way  as  the  carbon  atoms  in  ordinary  graphite.  In  the  case  of  single 
walled carbon nanotubes, the tube diameter is close to 1 nm. Multi-walled carbon nanotubes 
consist of several such tubes in each other (similar to a Russian doll but made out of tubes). 
Depending  on  the  structure  of  the  tube,  they  may  exhibit  very  high  thermal  and  electric 
conductivity and a high strength-to-weight ratio. 

The  substance  multi-walled  carbon  nanotubes  has  been  registered  under  REACH.278.  The 
registrant  has  indicated  that  the  substance  is  a  nanomaterial.  It  has  not  been  classified  as 
hazardous.279.  There  is  another  registration  of  multi-walled  carbon  nanotubes  under 
graphite.280  The  registrant  has  indicated  that  the  substance  is  a  nanomaterial.  It  has  been 

276 

277 

278 

279 

280 

p. 

to 

at: 

exposure 

2009.  Available 

(ENRHES), 
353; 

nanoparticles,  Luxembourg, 

-  Review  of  Health  and  Environmental  Safety 

EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view; 
Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report, 
http://nanopartikel.info/cms/lang/en/Wissensbasis/Fullerene/template/element2Category2ContainerList
?catTitle=Exposure&containerID=353&queryPath=/content/jahia/dana/ContentPage_3/Wissensbasis/F
ullerene/element2Category2ContainerList/ContentContainer_353. 
In  principle,  carbon nanotubes  are  a  special  type  of  carbon nanofibres. However,  sometimes  the  term 
“carbon  nanotubes”  is  used  to  characterise  the  thinner  carbon  fibres,  whereas  the  term  “carbon 
nanofibres” is used for the thicker variants. 
Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-b281d1a0-
c6d8-5dcf-e044-00144f67d031/DISS-b281d1a0-c6d8-5dcf-e044-00144f67d031_DISS-b281d1a0-c6d8-
5dcf-e044-00144f67d031.html. 
Except for: Respiratory sensitization; Effects via lactation; hazardous to the ozone layer (data lacking), 
all  other  fields  indicate  that  the  registrant  considers  data  for  all  endpoints  as  conclusive  but  not 
sufficient for classification. 
http://apps.echa.europa.eu/registered/data/dossiers/DISS-abda73cd-a2cd-3801-e044-
00144f67d249/DISS-abda73cd-a2cd-3801-e044-00144f67d249_DISS-abda73cd-a2cd-3801-e044-
00144f67d249.html 

EN 

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classified as hazardous with the following Hazard Statements (GHS): H319: Causes serious 
eye irritation; and H335: May cause respiratory irritation.281 

In  some  studies,  lung  toxicity  (inflammation,  cytotoxicity  and  tissue  damage)  was  observed 
after  carbon  nanotube  exposure.  There  are  indications  that  there  are  variations  between 
different types of carbon nanotubes, with single walled carbon-nanotubes often being shown 
to be more toxic than multi-walled carbon nanotubes, and longer length (> 20µm) resulting in 
greater  pathogenicity.  Some  animal  studies  detected  that  specific  modifications  of  carbon 
nanotubes showed effects similar to that of asbestos.282,283 Some of the observed effects may 
also be driven by metal contaminations.  

According  to  SRI,  the  market  of  carbon  nanotubes  (thinner  than  20  nm)  worldwide  is 
estimated around 200-250 tonnes (€30-40 million, mostly multi-walled carbon nanotubes) in 
2009. The largest use is as a product imparting electrical conductivity to plastic materials, e.g. 
in disk drive components or automotive plastic fuel lines and fenders (electrostatic coatings). 
Other uses include polymer additives, paints and coatings, fuel cells, electrodes, electrolytes 
and membranes in batteries, especially in miniature lithium batteries. There is a lot of research 
and development into new applications, including into “in-situ component use” which might 
in term complement and expand the use of silicon in electronics. 

According  to  SRI,  the  market  for  carbon  nanofibres  in  the  thickness  range  between  20  to 
several  100  nm  is  estimated  at  around  300-350  tonnes  (€50-60  million)  in  2009.  There  is  a 
strong  increase  of  use  of  nanofibres  in  lithium  ion  batteries  which  is  by  far  the  largest 
application. Other uses include fuel cells, fabrics for filtration or in plastic compounds for fuel 
lines. 

There  are  also  significantly  higher  estimates  in  terms  of  marketed  volumes  of  carbon 
nanotubes, nanofibers, fullerenes and POSS (around 3500 tonnes annually).284 

Workplace exposure can occur at production, use, when machining materials and from waste 
and depends on the work procedure and applied risk management measures. Measurements of 
airborne CNTs in workplaces in research and industrial settings have shown a likely exposure 
of  workers  in  some  cases.  Higher  levels  of  airborne  CNTs  were  found  in  particular  where 
processes  such  as  extrusion  and  cutting  of  bags  containing  nanomaterials,  dry-sawing  of 

281 

282 

283 

284 

to 

exposure 

nanoparticles,  Luxembourg, 

Except for the classification as Eye Irrit. 2 H319: Causes serious eye irritation; and STOT Single Exp. 3 
H335:  May  cause  respiratory  irritation.,  and  except  for:  Respiratory  sensitization;  Aspiration  hazard; 
Reproductive  toxicity;  Effects  via  lactation;  hazardous  to  the  ozone  layer  (data  lacking);  and 
carcinogenicity  (inconclusive),  all  other  fields  indicate  that  the  registrant  considers  data  for  all  other 
endpoints as conclusive but not sufficient for classification. 
EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view; 
(ENRHES), 
Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report, 
353; 
http://nanopartikel.info/cms/lang/en/Wissensbasis/kohlenstoffnanoroehrchen/template/element2Categor
y2ContainerList?catTitle=Exposure&containerID=165&queryPath=/content/jahia/dana/ContentPage_3/
Wissensbasis/kohlenstoffnanoroehrchen/element2Category2ContainerList/ContentContainer_165. 
Donaldson, K., Murphy, F. A., Duffin, R., Poland, C. A., 'Asbestos, carbon nanotubes and the pleural 
mesothelium:  a  review  and  the  hypothesis  regarding  the  role  of  long  fibre  retention  in  the  parietal 
pleura, inflammation and mesothelioma', Particle & Fibre Toxicology, Vol. 7, p. 5, 2010. 
http://www.marketresearch.com/Future-Markets-Inc-v3760/Carbon-Nanotubes-Nanofibers-Fullerenes-
POSS-6542959/ 

-  Review  of  Health  and  Environmental  Safety 

2009.  Available 

at: 

p. 

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60 

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nanomaterial-containing composites took place.285 Exposure to humans and the environment 
at the use stage is considered to be low because it is bound in a matrix in most uses. There are 
ongoing discussions whether release at the waste stage could lead to exposure to significant 
amounts of nanoparticles. Impacts on recycling are also under investigation. 

4.3. 

Carbon black (EC number 215-609-9) 

Carbon black is a black powder consisting of amorphous carbon to a degree of 80-95 %. It is 
manufactured by controlled incomplete combustion of hydrocarbons. There are various grades 
with different primary particle sizes, most of them between 1 nm and 100 nm (more than 95% 
of  global  production).  However,  there  are  also  grades  with  primary  particle  sizes  up  to  500 
nm. In industrial materials, the primary particles are normally aggregated or agglomerated. 

The substance carbon black has been registered under REACH286 (identified in one of three 
registration dossiers as a nanomaterial using the relevant tick-box). In one of three registration 
dossiers,  it  has  been  classified  as  hazardous  (Carc.  2)  with  the  following  Hazard  Statement 
(GHS): H351: Suspected of causing cancer; Route of exposure: Inhalation. In the other two 
dossiers, it has not been classified.287  

Based  on  results  from  experimental  studies288,  the  International  Agency  for  Research  on 
Cancer  (IARC)  of  the  World  Health  Organization  (WHO)  classified  carbon  black  as  a 
possible carcinogen to humans.289  

Among the few long term epidemiological studies, there are studies on respiratory health in 
the  carbon  black  industry.290,291  In  its  assessment  of  those  studies,  the  Engineered 
Nanoparticles  -  Review  of  Health  and  Environmental  Safety  (ENRHES)  concluded:  “The 
results  from  the  discussed  epidemiology  studies  of  the  carbon  black  industry  indicate  some 
adverse  effects  of  exposure  to  carbon  black  dust  on  respiratory  health.  However,  the  main 
findings are reassuring in that respiratory symptoms and lung function appear to be primarily 

285 

286 

287 

288 
289 

290 

291 

Möhlmann, C. et al., “Exposure to carbon nano-objects in research and industry”, INRS Occupational 
Health Research Conference 2011 “Risks associated with nanoparticles and nanomaterials”, April 2011, 
Conference proceedings, Session II, p. 64. 
Public  information  available  on:  http://apps.echa.europa.eu/registered/data/dossiers/DISS-76fd8ce3-
be46-5f12-e044-00144f26965e/DISS-76fd8ce3-be46-5f12-e044-00144f26965e_DISS-76fd8ce3-be46-
5f12-e044-00144f26965e.html; 
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ead7c63-
de5e-523a-e044-00144f67d031/DISS-9ead7c63-de5e-523a-e044-00144f67d031_DISS-9ead7c63-de5e-
523a-e044-00144f67d031.html; 
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9e9e2f65-
87c3-4085-e044-00144f67d031/DISS-9e9e2f65-87c3-4085-e044-00144f67d031_DISS-9e9e2f65-87c3-
4085-e044-00144f67d031.html. 
Except  for  the  classification  Carc.  2H351:  Suspected  of  causing  cancer;  Route  of  exposure: 
Inhalation.in one of three dossiers: and except for Effects via lactation (all three dossiers data lacking) 
and  for  Acute  toxicity  –  dermal;  Aspiration  hazard;  Reproductive  toxicity;  Germ  cell  mutagenicity; 
hazardous to the ozone layer (all one out of three dossiers: data lacking), all other fields on health and 
environmental  hazards  in  the  three  dossiers  indicate  that  the  registrants  consider  data  for  all  other 
endpoints as conclusive but not sufficient for classification. 
Note that experimental studies are typically conducted with high doses. 
International  Agency  for  Research  on  Cancer  –  IARC,  IARC  Monographs  on  the  Evaluation  of 
Carcinogenic  Risks  to  Humans  -  Carbon  Black,  Titanium  Dioxide,  and  Talc,  Volume  93,  (2010). 
Available at : http://monographs.iarc.fr/ENG/Monographs/vol93/index.php. 
Hodgson,  J.T.  and  Jones,  R.D.  1985,  A  mortality  study  of  carbon  black  workers  employed  at  five 
United Kingdom factories between 1947 and 1980, Archives of Environmental Health, vol. 40, pp. 261-
268. 
Sorahan,  T.,  Hamilton,  L.,  van  Tongeren,  M.,  Gardiner,  K.  and  Harrington,  J.M.  2001,  A  cohort 
mortality study of U.K. carbon black workers, 1951-1996, Am J Ind Med, vol. 39, pp. 158-170. 

EN 

61 

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accociated  with  current  exposure  rather  than  being  caused  by  cumulative  exposures.  A 
mortality  study  by  Sorahan  et  al.  2011  clearly  indicates  no  strong  and  little  suggestive 
evidence of excess non-malignant respiratory disease associated with working in the carbon 
black industry. Despite the fact that two of the five factories investigated generated evidence 
that there was excess mortality from lung cancer, the study has failed to link this disease to 
carbon  black  exposure.”292  IARC293  also  reviewed  those  studies,  along  with  a  number  of 
other  studies.294  It  considered  that  epidemiological  evidence  was  inconsistent  and  therefore 
concluded  that  that  there  is  inadequate  evidence  from  epidemiological  studies  to  assess 
whether carbon black causes cancer in humans. 295  

Several  authors  detected  inflammation,  cytotoxicity  and  tissue  damage  induced  by  carbon 
black  nanomaterials  in  the  lungs  as  a  consequence  of  carbon  black  exposure.296  297  Some 
cardiovascular effects as a consequence of carbon black exposure were also found.298 

According  to  SRI,  total  world  consumption  of  carbon  black  was  estimated  in  2010  at  9.6 
million  tonnes,  with  a  market  value  of  around  10  bn  €.  As  filler  material  carbon  black 
substantially increases the mechanical wear-resistance of rubber products. Around 73% of the 
world  production  goes  into  tyres,  and  another  19%  into  other  rubber  products.  Further 
applications include pigments (toners, printer inks) and antistatic fillers for plastic packaging. 
There  are  also  reported  uses  as  mascara,  flower  soil,  décor  paper  and  fibres,  and  to 
manufacture electrodes and carbon brushes.299 

Workplace exposure can occur at production, for example in rubber and tyre manufacturing, 
use,  from  abrasion  and  from  waste  and  depends  on  the  work  procedure  and  applied  risk 
management  measures.  Exposure  to  humans  and  the  environment  at  the  use  stage  varies 
according  to  application  but  can  be  significant,  e.g.  environmental  exposure  due  to  wear  of 
tyres.300  There  are  ongoing  discussions  whether  release  at  the  waste  stage  could  lead  to 
exposure to significant amounts of nanoparticles. 

4.4. 

Graphene flakes  

Graphene  flakes consist of a  single-layer graphite sheet.  They  became subject of significant 
research  since  2004,  when  graphene  flakes  were  isolated  through  new  methods,  for  which 
Andre Geim and Konstantin Novoselov were attributed the Nobel Prize in Physics for 2010. 

292 

293 
294 
295 

296 

297

298 

299 
300 

-  Review  of  Health  and  Environmental  Safety 

Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report, executive summary p. xiv. 
International Agency for Research on Cancer, http://www.iarc.fr/. 
http://monographs.iarc.fr/ENG/Monographs/vol93/mono93.pdf, p. 190. 
Note that IARC classified carbon black as a possible carcinogen to humans only based on results from 
experimental studies. 
EU-OSHA,  Workplace 
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticles/view. 

nanoparticles,  Luxembourg, 

2009.  Available 

(ENRHES), 

exposure 

at: 

to 

http://nanopartikel.info/cms/lang/en/Wissensbasis/CarbonBlack/template/element2Category2C
ontainerList?catTitle=Exposure&containerID=552&queryPath=/content/jahia/dana/ContentPage_3/Wis
sensbasis/CarbonBlack/element2Category2ContainerList/ContentContainer_552 
Niwa,  Y.,  Hiura,  Y.,  Murayama,  T.,  Yokode,  M.,  Iwai,  N.,  ´Nano-sized  carbon  black  exposure 
exacerbates atherosclerosis in LDL-receptor knockout mice´, Circulation Journal: Official Journal of the 
Japanese Circulation Society, 71, 2007, 1157-1161. 
Last six uses: http://nanopartikel.info/cms/lang/en/Wissensbasis/CarbonBlack. 
As part of the rubber matrix. 

EN 

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Graphene flakes are a semi-metal or zero-gap semiconductor. They have a very high electron 
mobility at room temperature, a high opacity and a number of other properties which makes 
them a promising material for a number of applications, even though market development is 
still  at  an  early  stage.  Possible  applications  are  sensors,  graphene  transistors,  integrated 
circuits,  electrochromic  devices,  transparent  conducting  electrodes,  solar  and  fuel  cells, 
antimicrobial  materials,  specific  materials  for  aircraft  (e.g.  lightning  strike  protection, 
prevention of ice adhesion, radiation hardness) and the automotive industry (e.g. prevention of 
static build-up on fuel lines).  

Exposure  to  humans  and  the  environment  is  estimated  to  be  rather  low,  as  the  material  is 
normally fixed in a matrix in the above applications. Behaviour of graphene flakes at the end-
of-life stage is still unknown. 

5. 

NANOPOLYMERS AND DENDRIMERS 

There are many nanomaterials used as an ingredient in polymers. This type of use is described 
under the relevant substances above.  

In addition, there are specific polymeric nanoparticles, nanotubes, nanofibres, nanofilms and 
nanostructures. Polymers are not subject to REACH registration.301 Dendrimers are a distinct 
group with specific polymeric structures. These substances are described below. Most of these 
substances are at an early stage of market development described applications are often still at 
research  and  development  stage.  Sufficiently  robust  data  on  market  quantities  of  marketed 
substances could not be found. 

Polymer  nanoparticles  are  nanoscale  polymeric  units  such  as  e.  g.  polyalcylbenzene-
polydiene nanoparticles (PAB-PDM). They are used e.g. in drug delivery systems or as filler 
material in matrix composites.  

Polymer  nanotubes,  nanowires  and  nanorods  have  potential  applications  in  electronic, 
magnetic,  optical,  optoelectronic,  and  micromechanical  devices.  One  of  the  promising 
polymeric nanotube types are polyaniline nanotubes (PANI) which show a good conductivity 
and may be used for e. g. conductive fabrics. 

Polyglycidylmethacrylate  (PGMA)  fibres  can  be  utilized  to  form  fabrics  and  so  called 
"smart  fibres",  which  change  their  properties  depending  on  the  environmental  conditions. 
Textiles  based  on  PGMA  fibres  may  switch  e.  g.  between  hydrophobic  and  hydrophilic, 
between conductive and non-conductive, between acidic and basic properties or may change 
colors etc. 

Nanocellulose (fibrils and crystals) can be used as a reinforcement material in composites and 
for medical implants.302 

Nanostructured  polymer-films  are  polymeric  nanoscale  thin  films  appearing  mainly  as 
polyalcylthiophene-films, polystyrene-polyethylene oxide (PS-PEO) films or as acrylic glass 
(Poly(methyl  methacrylate)  (PMMA))  films.  They  are  used  as  coatings  in  the  bio-medical 

301 

302 

EN 

Nevertheless,  in  most  cases,  the  monomers  the  polymer  consists  of  must  be  registered.  See  REACH 
http://eur-
Regulation, 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:136:0003:0280:en:PDF.  
http://nanopartikel.info/cms/lang/en/Wissensbasis/Cellulose 

Article 

6(3), 

63 

   EN 

                                                 
sector and have the potential to be used also in other sectors. There are also other nanofilms, 
e.g. based on styrene-ethylene-butylene-styrene (SEBS). 

Polyacrylonitrile  nanostructures  (PAN)  give  rise  for  utilization  in  semiconductors,  solar 
cells, sensors and membranes in filters. Their electrical properties are based on a variable and 
controllable bandgap for semiconductor use. 

Dendrimers are tree-shaped molecular structures similar to polymers. They are characterised 
by a high specific surface and, when dispersed, by a non-linear mass-viscosity relation. They 
are  relatively  expensive  and  there  is  not  much  information  about  the  current  market  size. 
Their  major  applications  include  pharmaceuticals,  light-emitting  diodes  and  lasers,  catalyst 
carriers,  cross-linking  agents  in  radiation-curable  surface  coating  resin,  semi-permeable 
membranes, polymer additives and biotechnological applications. 

6. 

QUANTUM DOTS 

Quantum  dots  are  semiconductors  whose  electronic  characteristics  are  closely  related  to  the 
size  and  shape  of  the  individual  crystal.  Typical  dots  are  made  of  nanomaterials  such  as 
cadmium selenide, cadmium sulfide, indium arsenide and indium phosphide. They are applied 
in  rather  small  quantities  in  computing,  biological  analysis,  photovoltaic  devices,  light 
emitting  devices  and  photodetector  devices.303  The  global  market  for  quantum  dots  is 
estimated at around €55 m.304 

7. 

NANOCLAYS 

Nanoclays  are  nanoparticles  of  layered  mineral  silicates  such  as  montmorillonite,  bentonite, 
kaolinite, hectorite, and halloysite. Nanoclays have uses e.g. as polymer nanocomposites, in 
paints, inks, greases, and cosmetics formulations, as a drug delivery vehicle, in waste water 
treatment305  and  in  tyres.306  The  global  market  for  nanoclays  has  been  evaluated  at  around 
€150  m.307  Several  substances  which  also  exist  as  nanoclay  have  been  registered  under 
REACH. However, the registration dossiers are generally unspecific to nanoclays. Moreover, 
according  to  industry  sources,  some  of  the  nanoclays  occur  in  nature  and  thus  are  exempt 
from registration.308 

8. 

NANOCOMPOSITES 

There  are  various  types  of  composites  of  nano-  and  non-nanomaterials.  These  materials  are 
not  separately  described  here  but  mentioned  as  possible  applications  of  the  relevant 
substances mentioned above. 

303 
304 
305 
306

307 
308  

http://en.wikipedia.org/wiki/Quantum_dot 
http://bccresearch.blogspot.com/2011/06/global-market-for-quantum-dots-to-grow.html 
http://www.ias.ac.in/matersci/bmsapr2006/133.pdf 

http://www.observatorynano.eu/project/filesystem/files/Briefing%20No.23%20Nanotechnolog

y%20in%20Automotive%20Tyres.pdf 
http://www.marketresearch.com/search/results.asp?query=nanoclays&submit1=Go 
http://www.reach-centrum.org/en/consortiumslt/consortia-under-reach/organoclays-reach-
consortium.aspx 

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9. 

OTHER 

There  are  reports  on  the  use  of  nitrogen  and  phosphorous  compounds  in  nanoform,  used  as 
flame  retardents  in  textile  industry  and  polyetherketones  in  nanoforms  as  anti-sticking 
coatings of pans.309 

In addition, there are a number of substances notified under the CLP Regulation which have 
been identified by the notifier as nanomaterial through ticking the “nanomaterial” tickbox, for 
which  little  further  information  could  be  found  on  uses  of  the  nanoform.  Thise  include 
manganese dioxide, divanadium pentoxide, dicopper oxide, siloxanes and silicones (see also 
Appendix 3).  

309 

http://www.bund.net/nc/themen_und_projekte/nanotechnologie/nanoproduktdatenbank/produktsuche/ 

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Appendix 3 
ECHA Analysis of Information on Nanomaterials retrieved in the ECHA 
Databases for REACH Registrations and CLP Notifications received by 
the end of June 2011 

This appendix is based solely on the content of the databases at the end of June  2011. Any 
registration  or  notification  received  after  this  has  not  been  systematically  screened  for 
information on nanomaterials. It is therefore possible that more registrations and notifications 
concerning  nanomaterials  have  been  received  after  this  date.  For  example,  two  registrations 
were received for multi-walled carbon nanotubes at the end of July 2011. 

Executive Summary 

The  REACH  registration  and  CLP  databases  maintained  by  ECHA  were  screened  for  those 
registrations and notifications that include information on nanomaterials. This involved doing 
a free-text search for “nano” in all machine readable fields in all registration and notifications 
stored  in  the  database.  In  addition  all  files  attached  to  registrations  were  screened.  “Nano” 
was  chosen  as  the  definite  search-term  for  the  screening  as  there  is  no  definition  for 
nanomaterial  in  REACH  or  CLP  nor  guidelines  on  how  to  report  information  on  size  for 
nanomaterials. The use of “nano” by a registrant/ notifier in a relevant context was considered 
to be an indication that the dossier may include nanomaterials or nanoforms within the scope 
of the registered/notified substance. 

Screening  of  the  REACH  registration  database  at  the  end  of  June  2011  yielded  a  list  of  78 
registered substances that include information on nanomaterials from the ca. 4,700 substance 
registrations stored in REACH registration database. Of these 78, three substance registrations 
had  explicitly  selected  “nanomaterial”  as  the  form  of  the  substance.  Two  substance 
registrations included possibly relevant information but had not selected “nanomaterial” as the 
form  of  the  substance.  Six  substance  registrations  included  “nano”  in  the  description  of  the 
registered  substance  but  where  the  registrant  referred  to  the  substance  as  being  nano-
structured rather than a nanomaterial. Eight specifically excluded nanoforms from the scope. 
For the vast majority of substances (59 of the 78 substances listed), “nano” was found solely 
in the context of read-across from studies performed on nanoforms of the registered substance 
and  it  cannot  be  definitely  concluded  based  on  the  information  included  in  the  respective 
dossiers whether or not nanoforms are within the scope of the registered substance.  

Screening of ca. 3.2 million notifications stored on the CLP notification database at the end of 
June 2011 yielded a list of 18 notifications where “nanomaterial” was selected as the form of 
the substance, one of which had included “nano” in both the chemical and EC name fields. An 
additional three notifications had included “nano” in the chemical name field.  

The list of substances retrieved from the REACH and CLP databases using this strategy and 
clearly including nanoforms within the scope of the substance are reported in Annexes 2 and 3 
of this report. It should be noted that the screening employed will not find those substances 
that  include  nanoforms  but  where  “nano”  was  not  included  in  any  field  of  the  respective 
registrations  and  notifications  or  in  any  file  attached  to  the  registrations.  However,  as 
registrants  and  notifiers  were  encouraged  to  use  “nano”  as  the  prefix  for  any  composition, 
analytical  data  and  information  requirement  that  referred  to  the  nanoform,  we  are  confident 

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that we have retrieved those substances where registrants/notifiers wished to explicitly include 
information on nanoforms. 

Based on the screening of the databases at the end of June 2011, it can be concluded that three 
registered  substances  from  the  REACH  registration  database  that  includes  ca.  26,000 
registrations  for  ca.  4,700  substances  and  18  CLP  notifications  from  the  ca.  3.2  million 
notifications in the CLP database had selected “nanomaterial” as the form of the substance in 
the  respective  registrations  and  notifications.  One  substance  was  common  to  both  lists.  It 
should  be  noted  that  registrants  include  classification  and  labelling  information  in  their 
respective registration dossiers and thus are not required to make a separate CLP notification 
for that substance. Thus the CLP notified substances on the list refer to those substances that 
are not currently registered by the party making the notification. 

The following report describes how ECHA retrieved information on nanomaterials stored in 
the ECHA databases for REACH registrations and CLP notifications. It details the basis for 
this action and describes the content of the ECHA databases in terms of what information is 
required to be reported according to specific deadlines for the applicable legislation and the 
format  in  which  this  information  is  stored.  The  absence  of  specific  requirements  for 
nanomaterials  in  both  the  REACH  and  CLP  legislations  is  also  discussed.  A  detailed 
summary  of  the  screening  strategy  undertaken  to  retrieve  information  from  the  databases  is 
included together with the results. 

1. 

BASIS  FOR  THE  COMPILATION  OF  A  LIST  OF  SUBSTANCES  THAT  INCLUDE 
INFORMATION ON NANOMATERIALS IN THE REACH AND CLP DATABASES 

In 2010, the Commission made an official request to ECHA for assistance in the preparation 
of  the  REACH  and  CLP  aspects  mentioned  in  the  2nd  Commission  communication  on  the 
Regulatory  aspects  of  nanomaterials.310  The  request  from  the  Commission  was  to  compile 
information on nanomaterial types and uses, including safety aspects, which has been reported 
by the chemical companies either in their registration dossiers submitted under the REACH311 
Regulation  or  in  notifications  to  the  Classification  and  Labelling  Inventory  submitted  under 
the CLP Regulation.312 This commitment was included in the ECHA workplan for 2011 under 
main  outputs  for  “Activity  7:  Scientific  and  technical  advice  to  EU  institutions  and  bodies: 
Report  compiled  for  the  Commission  by  30  June  containing  information  on  registered 
nanomaterials”. 

2. 

DESCRIPTION OF THE REACH AND CLP DATABASES HELD BY ECHA 

ECHA  is  the  responsible  EU  agency  for  the  implementation  of  both  the  REACH  and  CLP 
regulations.  The  REACH  regulation  which  came  into  force  on  the  1  June  2007  requires 
manufacturers, importers and downstream users to ensure that they manufacture, place on the 
market or use such substances that do not adversely affect human health or the environment 
(Article 1(3) of REACH) and is applicable to substances in whatever size or form. To comply 
with the regulation, manufacturers and importers are required to submit Registration dossiers 

310  
311  

312  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0366:FIN:en:PDF 
REACH:  Regulation  (EC)  No  1907/2006  concerning  the  Registration,  Evaluation,  Authorisation  and 
Restriction of Chemicals. 
Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures. 

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to ECHA including detailed information on their substances as defined in the REACH legal 
text. The CLP regulation obliges manufacturers, importers and downstream users to classify 
substances and mixtures placed on the market. This regulation explicitly requires these parties 
to  consider  the  forms  or  physical  states  in  which  the  substance  or  mixture  is  placed  on  the 
market  and  in  which  it  can  be  reasonably  be  expected  to  be  used  (CLP  Art  9(5))  when 
evaluating  the  available  information  for  classification.  To  fulfil  this  obligation,  CLP 
notifications including classification and labelling information defined in the CLP Regulation 
are required to be submitted to ECHA. Deadlines for submission of REACH registration and 
CLP notification dossiers to ECHA are defined in the respective regulations and are typically 
both tonnage and hazard profile specific.  

Since  1  June  2008,  ECHA  has  received  more  than  26,000  REACH  registrations  for 
approximately  4700  distinct  substances  (7  March  2011)  and  more  than  3.2  million  CLP 
notifications  for  approximately  109,000  distinct  substances  (1  April  2011).  The  tiered 
REACH registration deadlines for existing (or phase-in) chemicals mean that the registrations 
received by the 1 December 2010 deadline refer to those substances that are manufactured or 
imported per legal entity at > 1000 tons per year and those that are classified as carcinogenic, 
mutagenic  or  toxic  to  reproduction  (CMR)  or  have  a  classification  R50/53  that  are 
manufactured  per  legal  entity  at  greater  than  1  and  100  tonne  /year  respectively.  New 
substances  manufactured  or  imported  after  REACH  came  into  force  on  1  June  2007  are 
required to be registered when their tonnage exceeds 1 ton /year. The requirement to make a 
CLP notification by the 3 January 2011 deadline refers to substances placed on the market at 
> 1 ton per year and substances classified as hazardous under CLP and present in a mixture 
above the concentration limits specified in Annex I to CLP or in Directive 1999/45/EC which 
results in the classification of the mixture as hazardous irrespective of tonnage.  

These  REACH  registrations  and  CLP  notifications  are  stored  in  databases  maintained  by 
ECHA.  ECHA  therefore  has  a  very  large  repository  of  registration  and  notification  dossiers 
that can in principle provide information on nanomaterials registered or notified and therefore 
on  the  market.  Following  the  request  from  DG  ENTR  and  DG  ENV,  ECHA  has  searched 
these  received  registration  and  notification  dossiers  for  those  that  include  information  on 
nanomaterials and this report details the information found in the dossiers to date.  

3. 

APPLICATION OF REACH AND CLP REQUIREMENTS FOR NANOMATERIALS 

It  is  important  to  note  that  neither  the  REACH  nor  CLP  regulations  have  any  specific 
requirements for registrants and notifiers of substances that are nanomaterials or nanoforms of 
a substance nor is there a definition for nanomaterial in the REACH and CLP regulations. The 
European  Commission  addressed  this  in  a  series  of  papers  endorsed  by  the  REACH 
competent  authorities.  In  document  CA/59/2008  rev.1  “Nanomaterials  under  REACH”313,  it 
was clarified that nanomaterials are covered by the definition of substance under REACH and 
that REACH requirements are applicable to nanomaterials even though there are no specific 
provisions  in  the  legal  text  for  nanomaterials.  It  was  agreed  that  nanomaterials  could  be 
considered as either substances in their own right and thus registered as such or as forms of a 
substance  and  included  in  the  registration  dossier  of  corresponding  bulk  substance.  In  both 
cases,  the  respective  registration  dossier  should  include  all  relevant  information  on  the 
nanomaterial. The phase-in status of nanomaterials was also addressed and it was agreed that 

313  

http://ec.europa.eu/environment/chemicals/reach/pdf/nanomaterials.pdf 

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their  status  as  existing  chemicals  would  depend  on  the  registration  strategy  adopted  by  the 
registrant; nanomaterial substances are considered to be phase-in when listed on EINECS and 
pre-registered appropriately and nanoforms of a bulk substance are considered to be phase-in 
when the bulk substance is listed on EINECS and appropriately pre-registered. 

For CLP notifications, document CA/90/2009 Rev. 2 “Classification, labelling and packaging 
of  nanomaterials  in  REACH  and  CLP”314  states  that  classification  and  labelling  of 
nanomaterials should follow the rules set in the CLP regulation and that it should be done on a 
case-by-case basis giving due consideration to relevant available data. It was considered vital 
that the notifier evaluates whether changes in size, form or physical state influence hazardous 
properties. It was noted that a separate notification may be required for the nanoform of a bulk 
substance when the available data on the intrinsic properties indicates a difference in hazard 
class. 

There was therefore the expectation that the nanoform be reported in the dossier as any other 
form  of  the  substance  together  with  information  on  its  hazardous  properties  and  the  risk 
management  measures  to  handle  the  risk,  whenever  appropriate.  Registrants  and  notifiers 
were  encouraged  to  make  explicit  in  their  dossiers  if  they  believed  their  substance  was  a 
nanomaterial or a nanoform of a substance. 

REACH  registration  dossiers  are  submitted  in  IUCLID  format  to  ECHA.  IUCLID  refers  to 
the software application that enables registrants to store data on chemicals and to prepare and 
submit dossiers. To aid REACH registrants to include information on nanomaterials in their 
dossiers,  ECHA  prepared  a  technical  IUCLID  manual  “Nanomaterials  in  IUCLID  5.2”315 
where registrants were provided with practical instructions on the available IUCLID fields for 
nanomaterials  and  on  how  to  ensure  that  information  included  was  readily  retrievable.  For 
example, the  manual highlighted the new specific fields (picklists) available in IUCLID 5.2 
(release data 15 February 2010) where registrants could select “nanomaterial” as a form of the 
substance in the information requirements for “form of the substance” and in the classification 
and  labelling  sections  of  their  dossiers.  The  manual  also  provided  technical  instructions  on 
how to identity substances as nanomaterials and/or include nanoforms as different substance 
compositions in submitted registration IUCLID dossiers. 

CLP notifications could be submitted as IUCLID dossiers or via an on-line tool in REACH-
IT.  For  submissions  in  either  IUCLID  format  or  via  the  on-line  tool,  the  option  to  select 
nanomaterial was also available for “form of the substance” under classification and labelling. 

4. 

SUMMARY  OF  THE  SCREENING  STRATEGY  FOR  RETRIEVING  INFORMATION  ON 
NANOMATERIALS INCLUDED IN REACH AND CLP DOSSIERS 

The  strategy  adopted  for  retrieving  information  stored  in  REACH  registrations  and  CLP 
notifications was based on how the information is stored in the respective databases.  

REACH  registration  database:  REACH  registration  dossiers  are  stored  in  the  IUCLID 
database maintained by ECHA. Information can be retrieved from the dossiers by ECHA and 
member state competent authorities (MSCAs) by IUCLID query tools or via REACH-IT. For 
the  purpose  of  this  exercise,  a  combination  of  standard  IUCLID  query  tools  for  retrieving 

314  
315  

http://ec.europa.eu/environment/chemicals/reach/pdf/classif_nano.pdf 
http://iuclid.echa.europa.eu/index.php?fuseaction=home.documentation#technicalmanual 

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information  from  IUCLID  dossiers  and  other  search  tools  developed  in-house  were  used  to 
identify those dossiers that included information on nanomaterials in any IUCLID text-field 
or any file attached to the dossier. 

The screening strategy for REACH registration database is summarised as follows:  

• 

• 

• 

• 

Retrieve those dossiers that selected “nanomaterial” as form of the substance in the 
respective fields available  

Retrieve those dossiers who reported the nanoform as a separate composition of the 
substance in the appropriate section of the dossier  

Free-text  searching  of  all  fields  in  all  IUCLID  dossiers  in  the  ECHA  IUCLID 
database 

Free-text searching of all files attached to all IUCLID dossiers in the database (files 
attached include the CSR, analytical information relevant for substance identification 
and  any  other  relevant  information  the  registrant  wishes  to  include  to  fulfil  an 
information requirement) 

The  four  screening  steps  were  undertaken  independently  of  each  other  and  the  lists  of 
substances retrieved were cross-correlated with each other. The implications of the obligation 
to submit a joint REACH registration per substance and based on tonnages/hazard class are 
briefly outlined in Annex 1 as this determines how information is stored in the database and 
when such information is available to ECHA. 

CLP  notification  database:  all  CLP  notifications  received  are  stored  in  the  REACH-IT 
database and can be screened using IT tools developed specifically for this purpose.  

The screening strategy for the CLP notification database is summarised as follows:  

• 

• 

Retrieve those notifications that selected “nanomaterial” as form of the substance in 
the specific field available for this purpose  

Free-text searching of all searchable fields in the notifications (i.e. mainly substance 
identity-related fields) 

Choice  of  search  term:  “nano”  was  chosen  as  the  definite  search-term  for  screening  for 
information on nanomaterials/nanoforms of a substance in registration and CLP dossiers. As 
there is no definition for nanomaterial in REACH or CLP nor guidelines on how to report in 
the dossiers information on size for nanomaterials, this ruled out using the information on size 
as  the  sole  criterion  for  screening  for  those  dossiers  that  refer  to  nanomaterials/nanoforms. 
The  use  of  “nano”  by  a  registrant  was  considered  to  be  an  indication  that  the  dossier  may 
include  nanomaterials  or  nanoforms  within  the  scope  of  the  registered  substance  and  led  to 
further analysis of the dossier. 

Strengths and weaknesses of the screening strategy: An obvious weakness of the strategy 
is that where a registrant did not use the word “nano” to refer to a nanomaterial substance or 
nanoform  of  a  substance  included  in  the  scope  of  the  registered  substance,  such  dossiers 
would  not  be  found.  However  as  registrants  were  encouraged  to  include  information  on 
nanomaterials  and  in  particular  to  use  “nano”  as  the  pre-fix  for  any  composition,  analytical 
data,  information  requirement  that  referred  to  the  nanoform  as  detailed  in  the  technical 

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manual on how to include information on nanomaterials in IUCLID6, it is likely that where 
“nano” was not included in the dossier (1) the registrant did not consider or was not, in the 
absence of regulatory definition of nanomaterial, able to determine whether his substance was 
a nanomaterial/nanoform, (2) nanoforms were not within the scope of the registered substance 
or  (3)  the  absence  was  due  to  the  voluntary  nature  of  the  'nano'  information.  Thus,  the 
inclusion  of  “nano”  in  a  nanomaterial  relevant  context  in  the  dossier  was  assumed  to  be  an 
indication  that  the  registrant  wished  to  explicitly  address  nanomaterials/nanoforms  in  the 
dossier.  

5. 

SUMMARY OF THE OUTCOME OF THE SCREENING PROCESS  

From the searches undertaken of the REACH registration database at the end of June 2011, it 
can  be  concluded  that  78  substances  out  of  the  ca.  4700  substances  on  the  REACH 
registration database included some information on nanomaterials in the dossiers.  

From screening the ca. 3.2 million notifications in the C&L database at the end of June 2011, 
it can be concluded that 21 notifications had included some information on nanomaterials.  

6. 

CONCLUSIONS 

It  should  be  noted  that  the  screening  employed  does  not  find  those  substances  that  may 
include  nanoforms  if  the  key  word  “nano”  was  not  included  in  any  field  of  the  respective 
registrations  and  notifications  or  in  any  file  attached  to  the  registrations.  However,  as 
registrants  and  notifiers  were  encouraged  to  use  “nano”  as  the  pre-fix  for  any  composition, 
analytical  data  and  information  requirement  that  referred  to  the  nanoform,  we  are  confident 
that we have retrieved those substances where registrants/notifiers wished to explicitly include 
information on nanoforms. 

From  the  searches  undertaken,  it  can  be  concluded  that  78  substances  out  of  the  ca.  4700 
substances on the REACH registration database included some information on nanomaterials 
in the dossiers. Out of these 78 substances: 

• 

• 

• 

• 

3  substances  could  be  considered  to  have  included  nanoforms  within  the  scope  of 
the registered substance: these registrations had nanomaterial selected as the form of 
the  substance  in  the  available  picklists.  Note  however  that  there  were  3  separate 
submissions for one of the picklist substances and only one of these submissions had 
nanomaterial  selected  as  the  form  of  the  substance.  The  other  two  submissions 
included  “nano”  in  the  description  of  the  substance  where  it  was  considered  as  a 
nanostructured material. The substances are listed in Annex 2.  

2 substances included possibly relevant information but a nanomaterial had not been 
selected as the form of the substance. 

6  dossiers  included  “nano”  in  the  description  of  the  substance  but  referred  to  the 
substance as being nano-structured rather than a nanomaterial.  

For the vast majority of substances listed based on the REACH registrations (59 of 
the  78  substances  listed),  “nano”  was  found  solely  in  the  context  of  read-across 
where  there  was  no  evidence  that  nanoforms  are  within  the  scope  of  the  registered 
substance  but  extensive  read-across  from  studies  conducted  on  nanoforms  of  the 

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same or analogue substances were included in the dossier to fulfil specific REACH 
information requirements.  

• 

A  further  8  substances  also  used  extensive  read-across  from  studies  conducted  on 
nanoforms of the substance or analogue substances but where it was explicitly stated 
that nanoforms were not within the scope of the registered substance. 

From screening the C&L notification database, it can be concluded that 18 notifications out 
of  the  ca.  3.2  million  received  included  nanomaterial  as  the  form  of  the  notified  substance. 
Free  text  searching  of  the  name  fields  yielded  an  additional  three  notifications  that  had 
included  “nano”  in  a  relevant  context  in  the  chemical  name  field.  One  of  the  notifications 
where the picklist had been selected also included “nano” in both the chemical and EC name 
fields. It should be noted that for those substances that were registered by the REACH 2010 
deadline,  the  C&L  information  is  typically  included  in  REACH  registration  dossiers  and 
therefore a separate notification is not required. Thus, for a given substance, the parties that 
registered and notified are different. The substances retrieved are listed in Annex 3. 

The  list  based  on  REACH  registrations  includes  many  of  the  substances  on  the  OECD 
Working Party on Manufactured Nanomaterials (WPMN) list of representative nanomaterials 
(Cerium  dioxide,  aluminium  oxide,  iron  oxide,  zinc  oxide,  silica,  titanium  dioxide,  silver, 
nanoclays,  carbon  black).316  It  should  however  be  noted  that  some  of  the  registrations 
explicitly exclude nanoforms from the scope of the registered substance but read-across from 
studies  conducted  on  the  nanoform  to  fulfil  specific  REACH  information  requirements. 
Others  refer  to  studies  conducted  on  nanoforms  but  do  not  explicitly  state  whether  or  not 
nanoforms  are  within  the  scope  of  the  registered  substance,  while  other  stated  that  the 
substance was nanostructured rather than a nanomaterial.  

It  is  also  interesting  to  consider  why  certain  substances  were  not  found.  An  obvious  reason 
that certain substances like fullerenes were not found from either database is that the tonnages 
manufactured  and  imported  are  below  the  tonnage  triggers  for  the  registration/notification 
deadlines  and  it  is  not  classified  as  CMR,  R50/53  or  classified  as  hazardous  under  CLP.  In 
some cases it may have been unclear to registrants and notifiers whether or not their substance 
should  be  regarded  as  a  nanomaterial/nanoform.  For  example,  although  many  inorganic 
pigments  were  registered  by  the  2010  deadline,  very  few  pigments  are  included  on  the 
REACH  registration  based  list.  It  is  understood  that  inorganic  pigments  exist  in  grades  that 
would have a fraction under the 100 nm cut-off that is widely used to discriminate between 
bulk and nanoforms. However, there is no consensus of what “particle” refers to in terms of 
the interpretation of the 100 nm cut-off. In addition, different methods for measuring particle 
size  can  yield  vastly  different  values.  Also  there  was  no  information  available  on  how 
registrants should interpret the nano-status of substances that have particle size distributions 
with  size  fraction  below  100  nm  cut-off  or  whether  the  appropriate  metric  for  reporting  the 
particle size distribution should be mass or number based. However many of the substances 
on the C&L based list are pigments. 

Annex  1:  REACH  requirements  in  terms  of  one  registration  per  substance  and  the 
tonnage/hazard triggers that determine when a registration dossier shall be submitted.  

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http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2010)46&do

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Joint registration:  

REACH applies to substances and all REACH registrants of the same substance are required 
to submit certain information jointly to the Agency (Art (11) of REACH). Other information 
is company specific and thus to be submitted for each registrant. From a technical perspective, 
this means that only one joint registration dossier is submitted for each substance. This joint 
registration  dossier  is  split  in  a  joint  and  individual  (company  specific)  parts.  This  has 
implications on what information is retrievable from dossiers.  

In a joint registration dossier, registrants of the same substance organise themselves such that 
a lead registrant submits certain information on behalf of all members of the joint registration 
(in the joint part of the registration dossier). Other – typically company specific – information 
is contained in the individual (registrant specific) parts of the joint registration. In some cases, 
registrants may also choose to submit information which would normally be submitted in the 
joint part in the individual part of their dossier, if these registrants have confidentiality or cost 
related concerns or disagree with the lead registrant on the selection of information. 

The  scope  of  the  registered  substance  may  thus  be  defined  by  the  members  of  the  joint 
registration to include or exclude particular forms or compositions of the substance registered. 
This may or may not be explicitly stated in the dossiers. Normally, the lead registrant submits 
all the required physico-chemical, eco-toxicological and toxicological information required by 
REACH  for  that  substance.  There  is  also  a  possibility  to  submit  the  joint  chemical  safety 
report (CSR) on behalf of all registrants. This information is required to be applicable to all 
forms/compositions of the substance registered by all members of joint registration. However, 
as explained above, there may be cases where this information is contained in the individual 
part of the dossier.  

Thus, in terms of retrieving those dossiers from the database that include substance specific 
information  on  nanomaterials,  registrant  specific  information  on  substance  identity, 
manufacture,  uses  and  exposure  is  reported  in  all  dossiers  received  for  that  substance  while 
physico-chemical,  eco-toxicological  and  toxicological  information  is  typically  reported 
exclusively in the lead registrant dossier.  

Tonnage triggers:  

to 

the 

jointly, 

to  do  according 

they  are  only  obliged 

It  is  also  important  to  note  that  although  registrants  of  the  same  substance  are  required  to 
submit 
tonnages  as 
manufactured/imported  by  their  legal  entity.  For  example,  for  a  non-CMR,  non-R50/53 
substance,  only  those  manufacturers/importers  that  are  at  or  above  the  1000  ton/yr  trigger 
were required to register by the 2010 deadline. Manufacturers/importers with tonnages below 
1000  tons/yr  could  also  register  by  2010  but  are  not  required  to  do  so.  The  registration 
deadlines  for  lower  tonnages  are  2013  (100-1000  tons/yr)  and  2018  (1-10  tons/yr). 
Manufacturers/importers  below  1  ton/yr  do  not  have  an  obligation  to  submit  a  registration 
dossier  for  the  substance.  This  has  the  direct  implication  that  registrations  received  by  the 
2010  and  thus  stored  in  the  ECHA  database  refer  typically  to  those  substances 
manufactured/imported ≥ 1000 tons per year per legal entity or those CMR substances that are 
at or above 1 ton/yr per legal entity or those R50/53 substances that are at or above 100 ton/yr 
per legal entity. 

Annex  2:  List  of  publicly  available  substances  where  information  on  nanomaterials  was 
included in REACH registration dossiers received by the end of June 2011. 

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Note  this  list  does  not  imply  that  the  nanoform  has  been  registered  but  solely  reports  the 
context in which nano-relevant information was included in the respective registration dossier 
received  by  ECHA  for  these  substances.  Only  those  substances  that  clearly  included 
nanoforms within the scope of the substance are included. 

Substance 
name 

Section where "nano" indicated/found by free-text 
search 

/ 

EC 
list 
number 

Main  context 
where 
nanomaterial 
relevant 
information 
was retrieved 

Nanomate
rial 
selected 
as 
the 
“form  of 
the 
substance
” 

compositi
on  name/ 
compositi
on 
descriptio
n 

Context  where 
"nano" found in 
the  phys-chem, 
eco-tox and  tox 
IUCLID 
sections 

both 

Nano-
composition 

"Nano
" 
appear
s 
in 
public 
name/ 
chemi
cal 
name 

chemi
cal 
name 
and 
public 
name 

207-
439-9 

calcium 
carbonate 

2.1 

registrant 
explicitly 
included 
nanoforms 
within 
the 
scope  of  the 
registered 
substance 

215-
150-4 

215-
609-9 

cerium 
dioxide 

Carbon 
Black 

2.1 

4.1 

both 

Nano-
composition 

Read-across 

Annex  3:  Compiled  public  list  of  substances  where  information  on  nanomaterials  was 
included in C&L notifications received by the end of June 2011. 

Substance 
name 

/ 

EC 
list 
number

CAS 
number 

Chemical name 

Nanomaterial 
selected 
as 
the  form  of 
the substance  

"nano" 
included 
the 
in 
chemical 
name 

"nano" 
included  in 
EC 
the 
name  field 
of 
the 
notification

Manganese 
dioxide 

215-
202-6 

1313-
13-9 

Nickel 
monoxide 

215-
215-7 

1313-
99-1 

Zinc oxide 

215-
222-5 

1314-
13-2 

x 

x 

x 

EN 

74 

   EN 

  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
Substance 
name 

/ 

EC 
list 
number

CAS 
number 

Chemical name 

Nanomaterial 
as 
selected 
the  form  of 
the substance  

"nano" 
included 
in 
the 
chemical 
name 

"nano" 
included  in 
the 
EC 
name  field 
the 
of 
notification

Zirconium 
dioxide 

215-
227-2 

1314-
23-4 

Divanadium 
pentaoxide 

215-
239-8 

1314-
62-1 

Dicopper 
oxide 

215-
270-7 

1317-
39-1 

Anatase 
(TiO2) 

215-
280-1 

1317-
70-0 

Rutile 
(TiO2) 

Carbon 
black 

215-
282-2 

1317-
80-2 

215-
609-9 

1333-
86-4 

Aluminium 
oxide 

215-
691-6 

1344-
28-1 

Strontium 
titanium 
trioxide 

235-
044-1 

12060-
59-2 

Titanium 
dioxide 

236-
675-5 

13463-
67-7 

Titanium 
nitride 

247-
117-5 

25583-
20-4 

Strontium Titanate(SrTiO3)  

617-568-6 

617-
568-6 

844491-
94-7 

Silica, 
[[dimethyl[2-methyl-3-
(methylamino)propyl]silyl]oxy]-
and[(trimethylsilyl)oxy]-
modified 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

EN 

75 

   EN 

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
Appendix 4 
List of effects and property improvements through nanotechnologies  

Examples of the effects and property improvements through nanotechnologies317  

Functionality 
Electronical/Electrical 
– Conductivity 
– Dielectric layers 
– Superconductivity 
– Thermoelectricity 
– Electrochemical energy storage 

Chemical 
– Super-hydrophilicity 
– Super-hydrophobicity 
– Corrosion protection 
– Catalysis 
– Flame protection 
– Fire protection 
– Adsorption power 
– Adhesion power 
– Dissolving power 

Thermal 
– Heat protection  
– Heat insulation 
– Heat conduction 
– Heat storage 

Magnetic 
– Magnetically soft materials 
– Magnetoelectronics 
– Magnetorheology 
– Magnetic induction heat 

Biological 
– Antimicrobial effect  
– Bioavailability 
– Biocatalytics 
– Moleculare recognition 
– Biocompatibility 
– Cell permeability 

Application Examples 
• Electrically conductive polymers through integration of carbon nanotubes into the  
polymer matrix for antistatic applications and electromagnetic shielding. 
• Improved high-temperature superconductivity through nanoscaled substructures  
for increased ampacity and cost-efficient sol-gel-materials for layer production. 
• More efficient thermoelectrics for power conversion of heat through nano- 
structured semiconductor connections. 
• Nanoporous “low-k“-layers for the reduction of delay in conduction in CMOS-circuits 
• Antifogging effect through super-hydrophilic titanium dioxide nanocoatings for  
glasses and exterior mirrors of cars. 
• Dirt-repellent coatings, inter alia, through nanoparticle-modified fluor-siloxane/ 
silane coating agents for textiles, furnishings and façade surface finishings. 
• Fire-protection windows on the basis of transparent, nanoparticular fire-protection  
gels and layers, which, under the impact of heat, form ultra-fine gas bubbles with  
strongly heat-insulating effect. 
• Flame-inhibiting effect for plastic casings and cables through integration of cataly- 
tic nanoparticles in the polymer matrix, which prevent the spreading of flames by  
accelerated formation of non-combustible carbonization residues.  
• Anti-fingerprint layers for stainless steel and metal surfaces on the basis of thin glass 
coatings 
• Efficient adsorbent materials for gas storage or for the removal of contaminants 
through extended active surfaces and adjustable pore sizes 
• Nanostructured heat-protection layers and alloys for turbine materials to achieve 
better energy conversion rates at increased working temperatures.  
• Superinsulating nanofoams (aerogels, polymer foams) for heat insulation in buildings  
and industrial processes. 
• Better heat conduction through nanofluids and nanocomposite materials on CNT- 
basis in industrial processes or in solarthermics 
• Efficient heat storage through micro/nanoencapsulated phase change materials to be 
integrated in the facade components. 
• Nanocrystalline, magnetically soft iron alloys capable of having extraordinary  
magnetic properties impressed on them, inter alia for high-capacity components in  
grids (e.g. toroidal tape core, transformers, choke coils). 
• Magnetic layer stacks with giant magnetoresistance properties for magneto- 
electronic sensors and data memories.  
• Dispersions of surface-stabilized nanoscaled iron particles (ferrofluids) with 
magnetically controllable viscosity for sealings, shock absorbers etc. 
• Iron oxide nanoparticles for heat generation by means of alternating electro- magnetic 
fields (e.g. for switchable adhesives or hyperthermal cancer therapy. 
• Antimicrobial equipment of plastics in medical engineering, furniture surfaces,  
textiles, through silver nanoparticles.  
• Higher bioavailability of medical agents and dietary supplement substances  
through liposome encapsulation and nanoemulsions.318 
• Nanoparticles as carriers for the introduction of genetic material into cells  
(gene vectors) in gene therapy. 
• Molecular recognition of diseased cells for effective drug delivery through surface 
functionalized drug-delivery systems. 
• Nanostructured implant surfaces and nanoparticular bone substitute materials for 
increased biocompatibility in regenerative medicine. 
• Nanostructured templates and carrier substances for efficient biocatalysts.  

317  

318 

EN 

2009- 

NanoDE-Report 
(http://www.bmbf.de/pub/nanode_report_2009_en.pdf) 
Note  that  these  are  not  necessarily  covered  by  the  Definition  of  Commission  Recommendation 
2011/696/EU. 

Nanotechnologie 

Deutschland 

Status 

quo 

der 

in 

76 

   EN 

 
 
 
 
 
 
 
 
                                                 
Appendix 5 
EU funded research in Nanosafety  

The  European  Commission  has  started  funding  projects  addressing  specifically  nanosafety 
since the 5th EU Framework Programme for Research and Technological Development (FP5, 
1998-2002). Nanosafety is strategically addressed since the beginning of FP6, with a regular 
annual budget increase, from 800 k€ in 2004 to 30 M€ in 2010. Globally, from 2004 to 2010, 
FP6 and FP7 projects dedicated to nanosafety issues represented a total investment of 185 M€ 
(of which 130 M€ from the framework programme budget). 

The  framework  programme  calls  are  conceived  to  cover  all  aspects  necessary  for  the  risk 
assessment  and  risk  management  of  nanomaterials:  physico-chemical  characterisations  of 
nanomaterials,  fate  and  behaviour  in  biological  and  environmental  media,  bio-nano 
interactions,  nano-toxicity  and  nano-ecotoxicity,  life  cycle  analysis  of  nanomaterial-
embedded products (including recycling and final treatment), measurement devices, exposure, 
worker protection, risk assessment tools and risk management strategies.  

These European projects are aimed at closing the knowledge gaps required for the assessment 
and development of relevant regulation founded on scientific knowledge. While the research 
is not aimed at producing regulatory assessment data for any specific nanomaterial currently 
in the market place, all projects have part of their activities that are specifically dedicated to 
dissemination  of  the  project's  results  to  stakeholders  and  general  public.  These  activities 
include  workshops  such  as  the  joint  JRC/ENPRA  stakeholders'  workshops  (www.enpra.eu), 
publications in peer-reviewed journals and public reports. A good example of a public report 
was produced by the FP7 ENRHES319 project which performed a comprehensive and critical 
scientific  review  of  the  health  and  environmental  safety  of  fullerenes,  carbon  nanotubes 
(CNTs), metal and metal oxide nanomaterials (http://ihcp.jrc.ec.europa.eu/whats-new/enhres-
final-report). Participants to these European projects also often contribute to more regulatory 
oriented activities, such as the RIP-oNs studies and the OECD-WPMN work, or even sit in 
scientific committees such as SCENHIR, ensuring therefore that the knowledge produced in 
the projects be transmitted.  

As  an  exception  to  the  above,  a  topic  addressing  "Regulatory  Testing"  is  planned  for  2012 
calls. The objective of the call is to provide legislators with a set of tools for risk assessment 
and decision making for the short to medium term, by gathering data and performing pilot risk 
assessment,  including  exposure  monitoring  and  control,  for  a  selected  number  of 
nanomaterials used in products. The outcomes of the project should also feed the work of the 
OECD-WMPN. A 10 M€ EC contribution is planned and a leverage effect from 3 to 5 times 
is expected from Member States and industries. 

Finally,  the  EU  NanoSafety  Cluster  is  a  DG  RTD  initiative  to  maximise  the  synergies 
between  projects  addressing  all  aspects  of  nanosafety  including  toxicology,  ecotoxicology, 
exposure  assessment,  mechanisms  of  interaction,  risk  assessment  and  standardisation.  The 
NanoSafety Cluster comprises 31 projects funded under FP7 and five projects funded under 
FP6.  Additionally,  national  projects  may  contribute  to  the  overall  aims  of  the  Cluster.  The 
main objectives of the NanoSafety Cluster are: to facilitate the formation of a consensus on 

319 

Engineered  Nanoparticles 
http://ihcp.jrc.ec.europa.eu/whats-new/enhres-final-report. 

-  Review  of  Health  and  Environmental  Safety 

(ENRHES), 

EN 

77 

   EN 

                                                 
nanotoxicology in Europe ; to provide a single voice for discussions with external bodies ; to 
avoid duplicating work and improve efficiency ; to improve the coherence of nanotoxicology 
studies  and  harmonize  methods  ;  to  provide  a  forum  for  discussion,  problem  solving  and 
planning  R&D  activities  in  Europe  ;  and  to  provide  industrial  stakeholders  and  the  general 
public with appropriate knowledge on the risks of nanoparticles and nanomaterials for human 
health and the environment. The NanoSafety Cluster also delivers yearly a compendium of all 
its  projects,  which  includes  consortia  compositions,  projects  objectives  and  results.  The  last 
edition can be found at: www.nanosafetycluster.eu. 

EN 

78 

   EN 

Appendix 6 
Nanomaterials and worker protection: Main publications and websites  

1. 

• 

EU-OSHA320

 REFERENCES TO NANOMATERIALS USE AT THE WORKPLACE: 

Report  -  Expert  forecast  on  emerging  chemical  risks  related  to  occupational 
safety and health (2009) 

http://osha.europa.eu/en/publications/reports/TE3008390ENC_chemical_risks/view  

EU-OSHA has published a series of expert forecasts providing an overview of the potential 
emerging risks in the world of work (physical, biological, psychosocial and chemical risks). 
Among  the  top  ten  emerging  risks,  three  have  in  common  their  physico-chemical  state  as 
insoluble  particles  or  fibres:  nanoparticles  and  ultrafine  particles,  diesel  exhaust,  and  man-
made  mineral  fibres.  The  experts  agreed  that  nanoparticles  and  ultrafine  particles  pose  the 
strongest emerging risk. 

• 

Literature review - Workplace exposure to nanoparticles (2009) 

http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_nanoparticle
s/view  

This  report  focuses  on  the  possible  adverse  health  effects  of  workplace  exposure  to 
engineered nanomaterials and possible subsequent activities taken to manage the risk. In order 
to provide a broad overview, information from different sources such as scientific literature, 
policy  documents,  legislation  and  work  programs  were  collected.  Documents  from  the  EU 
were  given  priority,  although  national  and  international  activities  have  also  been  described. 
Studies published up to November 2008 have been considered in the report. 

As the conclusion of this review, the following topics were identified as priorities for future 
actions and activities: 

– 

– 

– 

– 

– 

– 

identification of nanomaterials and description of exposure 

measurement  of  exposures  to  nanomaterials  and  efficacy  of  protective 
measures 

risk assessment of nanomaterials in line with the current statutory framework 

in vivo studies for assessment of the health effects of nanomaterials 

validation of the in vitro methods and methods of physico-chemical properties 
as methods to determine health effects 

training  of  workers  and  practical  handling  guidelines  for  activities  involving 
nanomaterials in the workplace. 

320 

European Agency for Safety and Health at Work, http://osha.europa.eu/en/front-page/view. 

EN 

79 

   EN 

                                                 
• 

Literature  review  –  Risk  perception  and  risk  communication  with  regards  to 
nanomaterials in the workplace (2012) 

http://osha.europa.eu/en/publications/literature_reviews/risk-perception-and-risk-
communication-with-regard-to-nanomaterials-in-the-workplace/view 

This  review  found  that  communication  on  nanomaterials  is  still  poor,  with  a  majority  of 
Europeans  not  knowing  what  nanotechnology  is.  Even  in  workplaces  where  manufactured 
nanomaterials  are  found,  the  level  of  awareness  is  low.  For  example,  75%  of  workers  and 
employers in construction are not aware they work with them. 

There are some initiatives to communicate the risks of manufactured nanomaterials and how 
to  manage  these  (though  not  always  targeted  at  the  workplace),  for  example  by  major 
producers,  some  trade  unions,  national  dialogues  within  some  Member  States,  and  Europe-
wide  through  the  Communication  Roadmap  by  the  European  Commission.  But  much  more 
still  needs  to  be  done  (preferably  jointly  by  policymakers,  the  social  partners,  national 
occupational  safety  and  health  bodies,  public  health  agencies,  sectoral  associations,  etc.)  as 
poor  risk  communication  may  generate  confusion  and  lead  to  unjustified  fears  or  to 
underestimation  of 
risk  prevention.  Risk 
communication  strategies  need  to  help  employers  make  informed  decisions  about  their 
workplaces  and  put  adequate  prevention  measures  in  place,  and  to  empower  individual 
workers  to  take  personal  control  of  their  own  situations  in  order  to  protect  themselves 
adequately. 

risks,  with  consequent 

inadequate 

the 

• 

Database  of  company  Good  Practice  on  the  management  of  risks  from 
nanomaterials in the workplace 

http://osha.europa.eu/en/practical-solutions/case-studies/index_html/practical-
solution?SearchableText=&is_search_expanded=True&getRemoteLanguage=en&keywords%
3Alist=nanotechnology&nace%3Adefault=&multilingual_thesaurus%3Adefault=&submit=S
earch 

EU-OSHA  has  developed  an  on-line  database  of  company  Good Practice  examples  of good 
workplace management of manufactured nanomaterials which covers a variety of industries, 
such as textile, construction and medical applications, in different EU Member States. 

• 

A  number  of  useful  links  are  also  available  in  the  agency´s  “Useful  links”  section 
“dangerous substances and new technologies” 

Further to these EU-OSHA publications and the sources referenced in the bibliography list of 
these reports, a number of publications and references with relevance to occupational health 
and safety and the priorities identified in EU-OSHA studies are listed below: 

2. 

EU MEMBER STATES 

AUSTRIA 

• 

The  Austrian  Nanotechnology  Action  Plan 
in  English  at 
http://www.umweltnet.at/filemanager/download/60006/  )  identifies  needs  for  action 
and formulates recommendations related to, among others, worker protection 

(available 

EN 

80 

   EN 

• 

Institut für Technikfolgen-Abschätzung, ITA (Institute of Technology Assessment of 
the Austrian Academy of Sciences)  

• 

• 

• 

• 

Nanotrust project http://nanotrust.ac.at/nano.ita.en/index.html  

Nanotechnologies  –  nanotextiles,  voluntary  agreements  in  industry  (2010) 
http://osha.europa.eu/en/news/nanotechnologies-2013-nanotextiles-voluntary-
agreements-in-industry  

Nanotechnologies 
http://osha.europa.eu/en/news/nanotechnologies-assessment-of-nanosilver-
products 

of  nanosilver  products 

-  Assessment 

(2010) 

Neurotoxicity 
http://osha.europa.eu/en/news/nanotechnologies-neurotoxic-effects-of-
nanomaterials 

of 

nanoproducts 

• 

Austrian Labour  Inspectorate: has a section on nanomaterials on its webpages, in 
German  only:  http://www.arbeitsinspektion.gv.at/AI/Arbeitsstoffe/nano/default.htm. 
Also includes the results of case studies of companies working with nanomaterials, 
performed 
2009: 
http://www.ppm.at/downloads/umgang_mit_nano_im_betrieb.pdf.  The  Austrian 
Labour  Inspectorate  is  also  currently  working  on  guidelines  for  the  safe  use  of 
nanomaterials at the workplace. 

in 

GERMANY 

• 

• 

German Government Nano Initiative Action plan - also includes worker protection. 
Action  Plan  2015  only  in  German;  Action  Plan  2010  also  in  English,  available  at: 
http://www.bmbf.de/de/nanotechnologie.php  

Bundesanstalt  für  Arbeitsschutz  und  Arbeitsmedizin,  BAuA  (German  national 
institute for occupational safety and health):  

• 

• 

• 

Literature  overview  2008-2010  related  to  the  use  of  nanotechnologies  and 
German: 
occupational 
http://www.baua.de/de/Bibliothek/Informationsdienste/Nanotechnologie.pdf?_
_blob=publicationFile&v=3  

health, 

safety 

and 

in 

BAuA  also  provides  a  dedicated  webpage  with  national  actions,  research  and 
codes  of  practice,  as  well  as  information  on  the  use  of  nanotechnologies  and 
exposures  to  nanoparticles  in  practice.  A  selection  of  documents  is  translated 
http://www.baua.de/cln_137/de/Themen-von-A-
into 
Z/Gefahrstoffe/Nanotechnologie/Nanotechnologie.html for the German version 
and 
http://www.baua.de/cln_137/en/Topics-from-A-to-Z/Hazardous-
Substances/Nanotechnology/Nanotechnology.html for the English version. 

English. 

See 

Among others, BAuA funded a project aiming at developing a portable device 
to  measure  airborne  nanoparticles  in  the  workplace  (performed  by  IUTA, 
Duisburg  –  ended  2010).  BAuA  has  now  started  to  perform  workplace 
measurements  of  airborne  nanoparticles  in  the  industry:  (in  German) 

EN 

81 

   EN 

http://www.baua.de/de/Themen-von-A-
Z/Gefahrstoffe/Nanotechnologie/pdf/Forschung-
Entwicklung.pdf?__blob=publicationFile&v=7  

Elaborated  by  BAuA  and  the  Association  of  chemical  industries  (Verband  der 
Chemischen Industrie, VCI): “Guidance for handling and use of nanomaterials in 
(2007): 
the 
http://www.baua.de/cae/servlet/contentblob/717966/publicationFile/48357/guidance.
pdf  

workplace” 

Institut  für  Arbeitsschutz  der  Deutschen  Gesetzlichen  Unfallversicherung,  IFA 
(Institute  for  Occupational  Safety  and  Health  of  the  German  Social  Accident 
Insurance):  Webpages  on  nanomaterials  and  OSH,  including  information  on 
workplace  measurement,  risk  assessment  and  prevention  measures,  in  English 
(http://www.dguv.de/ifa/en/fac/nanopartikel/index.jsp 
German 
(http://www.dguv.de/ifa/de/fac/nanopartikel/schutzmassnahmen/index.jsp )  

and 

in 

) 

Berufsgenossenschaften der Bauwirtschaft, BG-Bau (German statutory insurance for 
the construction sector):  

• 

• 

Product  list  of  nano-containing  construction  and  cleaning  products: 
http://osha.europa.eu/en/news/DE-nanoparticles-construction-cleaning 

list 

2011: 
up-dated 
The 
http://www.bgbau.de/d/pages/praev/fachinformationen/gefahrstoffe/nano/PDF-
files/nano-liste.pdf  

was 

list 

in 

Hessisches  Ministerium  für  Wirtschaft,  Verkehr  und  Landesentwicklung  (Hessen 
Ministry  of  Economy,  Transport  and  Development):  Guidance  on  the  safe  use  of 
nanomaterials  in  the  varnish  and  paint  industry  (2009)  in  German  only: 
http://www.hessen-nanotech.de/mm/Betriebsleitfaden_NanoFarbeLacke_Vorab.pdf  

Roller,  M  (Advisory  Office  for  Risk  Assessment,  Dortmund)  “Carcinogenicity  of 
inhaled nanoparticles”, Inhalation Toxicology, 2009; 21(S1): 144–157 

• 

• 

• 

• 

• 

EN 

82 

   EN 

FRANCE 

• 

French  Ministry  of  Labour:  Plan  Santé  au  Travail  2010-2014  (Plan  for  health  at 
work): http://www.travailler-mieux.gouv.fr/IMG/pdf/PST_2010-2014.pdf 

Sets up objectives with regards to nanomaterials and worker protection:  

• 

• 

• 

• 

• 

Develop health surveillance of workers exposed to nanomaterials 

the  efforts 

Strengthen 
identify  workplace  exposure  scenarios  and 
characterise  exposure  in  order  to  develop  adequate  measurement  tools  and 
methods 

to 

Support EU level initiatives to implement legislative measures on traceability 
of nanoparticles 

Improve  information  to  workers  likely  to  be  exposed  to  nanomaterial 
containing waste. 

the  French  National  Agency  for  Food,  Environment  and 
Called  on 
Occupational  Health  and  Safety  ANSES  to  draft  a  Good  Practice  guide  on 
nanomaterials  in  the  workplace  in  2010  building  upon  the  2008  report 
“Nanomaterials 
work” 
(http://www.afsset.fr/upload/bibliotheque/258113599692706655310496991596
/afsset-nanomateriaux-2-avis-rapport-annexes-vdef.pdf) 

Safety 

at 

– 

• 

• 

Agence  nationale  de  sécurité  sanitaire,  de  l’alimentation,  de  l’environement  et  du 
travail, ANSES (French National Agency  for  Food,  Environment  and  Occupational 
Health  and  Safety):  New  specific  Control-Banding  tool  for  nanomaterials 
http://osha.europa.eu/en/news/fr-new-specific-control-banding-tool-for-
nanomaterials-developed-by-anses 

French  national  public  debate  on  the  general  options  on  the  development  and 
regulation of nanotechnologies « Débat public sur les options générales en matière de 
développement  et  de  régulation  des  nanotechnologies »  http://www.debatpublic-
nano.org/debat/debat_public.html 

NETHERLANDS 

• 

• 

The  Stoffenmanager  Nano  ModuleNano  (2011):  Adaptation  of 
the  Dutch 
occupational  risk  assessment  tool  for  workplace  dangerous  substances 
at: 
(“Stoffenmanager”) 
http://nano.stoffenmanager.nl/Default.aspx  

nanomaterials. 

Available 

to 

Delft  University  of  Technology  (TU  Delft),  in  cooperation  with  the  Lawrence 
Livermore  National  Laboratory  (USA):  Paik,  S.,  Y.&  Zalk,  D.  M.,  Swuste  P., 
“Application  of  a  Pilot  Control  Banding  Tool  for  Risk  Level  Assessment  and 
Control of Nanoparticle Exposures”, Ann. Occup. Hyg., Vol. 52, No. 6, pp. 419–
428, 2008 http://annhyg.oxfordjournals.org/content/52/6/419.full.pdf+html 

EN 

83 

   EN 

• 

• 

SPAIN 

• 

• 

TU  Delft,  “Nanosafety  Guidelines.  Recommendations  for  research  activities  with 
2008: 
‘free 
www.veiligheidskunde.nl/xu/document/cms/streambin.asp?requestid=43531312-
6BA0-400D-B916-7562D0EEBDE3  

nanostructured 

matter’”, 

Social  and  Economic  Council  of  the  Netherlands  (SER),  “Nanoparticles  in  the 
Workplace:  Health  and  Safety  Precautions”.  Advisory  Report.  Working  Conditions 
Committee. 2009. www.ser.nl/en/publications/publications/2009/2009_01.aspx  

Instituto Nacional de Seguridad e Higiene en el Trabajo, INSHT (National Institute 
for Safety and Hygiene at Work): “Risk level assessment of nanoparticle exposure 
only: 
by 
http://www.insht.es/InshtWeb/Contenidos/Documentacion/FichasTecnicas/NTP/Fich
eros/821a921/877w.pdf  

banding” 

Spanish 

control 

in 

Instituto  Sindical  de  Trabajo,  Ambiente  y  Salud,  ISTAS  (Trade  Union  Institute  for 
Work,  Environment  and  Health):  Web  pages  on  nanomaterials,  with  practical 
information on measurement, risk assessment and control measures, in Spanish only: 
http://www.istas.net/web/index.asp?idpagina=3332  

UNITED KINGDOM 

• 

Health and Safety Executive:  

•  Websection 

on 
http://www.hse.gov.uk/nanotechnology/index.htm?ebul=hsegen&cr=8/31-jan-
11 

nanomaterials 

• 

In  particular,  on  fire  and  explosion  properties  of  nanopowders  (2010) 
http://osha.europa.eu/en/news/uk-2013-new-hse2019s-report-on-fire-and-
explosion-properties-of-nanopowders  

• 

British Standards Institute, BSI:  

• 

• 

“Nanotechnologies  –  Part  2:  Guide  to  safe  handling  and  disposal  of 
manufactured nanomaterials.”, 2007: http://www.bsi-global.com/en/Standards-
and-Publications/Industry-Sectors/Nanotechnologies/PD-6699-2/Download-
PD6699-2-2007/  

“Guidance  on  the  labelling  of  manufactured  nanoparticles  and  products 
2007: 
containing 
http://www.bsigroup.com/upload/Standards%20%26%20Publications/Nanotec
hnologies/PAS130.pdf 

nanoparticles”, 

manufactured 

• 

Institute of Occupational Medicine (IOM): “Safenano”, an initiative designed to help 
industrial  and  academic  communities  to  quantify  and  control  the  risks  to  their 
workforce,  as  well  as  to  consumers  and  the  environment.  The  website  includes  a 
publication  database,  and  some  guidance  e.g.  on  workplace  risk  assessment. 
http://www.safenano.org/Home.aspx  

EN 

84 

   EN 

3. 

OTHER COUNTRIES 

SWITZERLAND 

• 

• 

• 

• 

• 

State Secretariat for Economic Affairs SECO, “Safety data sheet (SDS): Guidelines 
2010: 
for 
http://www.seco.admin.ch/dokumentation/publikation/00009/00027/04546/index.ht
ml?lang=en&utm_source=oshmail&utm_medium=email&utm_campaign=oshmail-
104 

nanomaterials”, 

synthetic 

Swiss Accident Insurance Fund SUVA: “Nanoparticles in the workplace” (2009), in 
German  only,  includes  information  on  health  effects,  workplace  measurement,  risk 
http://www.suva.ch/startseite-suva/praevention-
assessment 
suva/arbeit-suva/gefahren-filter-suva/gesundheitsgefaehrdende-stoffe/gs-
nanopartikel/nanopartikel-arbeitsplaetzen-suva/filter-detail-
suva.htm?WT.mc_id=shortcut_nanopartikel  

and  management: 

Swiss Nano-Inventory: by the IST, Institute for Work and Health, supported by the 
Federal  Office  of  Public  Health  (BAG),  the  Federal  Office  for  the  Environment 
(BAFU),  the  State  Secretariat  for  Economic  Affairs  (SECO),  the  Swiss  National 
the  French  Agency  for  Occupational  and 
Accident  Insurance  Fund,  and 
Environmental Health Safety (AFSSET): “Swiss Nano-Inventory – An assessment of 
the  usage  of  nanoparticles  in  Swiss  industry”  (2008):  http://www.suva.ch/ist-
nanoinventory.pdf  

Federal  Office  of  Public  Health,”  Precautionary  Matrix 
for  Synthetic 
Nanomaterials”,  structured  method  to  assess  the  "nanospecific  precautionary  need" 
of workers, consumers and the environment, for enterprises, revised on the basis of 
users’ 
2010. 
the 
http://www.bag.admin.ch/themen/chemikalien/00228/00510/05626/index.html?lang=
en 

experience 

beginning 

of 

at 

Groso A, Petri-Fink A, Magrez A, Riediker M, Meyer T, (Occupational Safety and 
Health,  School  of  Basic  Sciences,  Ecole  Polytechnique  Fédérale  de  Lausanne), 
“Management of nanomaterials safety in research environment”, Part Fibre Toxicol. 
2010 Dec 10;7:40, http://www.ncbi.nlm.nih.gov/pubmed/21143952 

USA: National Institute for Occupational Safety and Health, NIOSH:  

• 

• 

• 

Webpages 
http://www.cdc.gov/niosh/topics/nanotech/default.html 

nanotechnologies 

on 

and 

OSH: 

on 

nanoparticles 
Research 
http://osha.europa.eu/en/news/niosh-research-on-health-effect-of-breathing-
nanoparticles 

breathing 

health 

effect 

of 

(2010): 

Approaches  to  Safe  Nanotechnology  -  Managing  the  Health  and  Safety  Concerns 
Associated 
(2009): 
http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf 

Nanomaterials 

Engineered 

with 

EN 

85 

   EN 

• 

• 

Research  and  prevention  recommendations  directed  at  workplace  risk  assessment: 
- Schulte, PA, et al., “Issues in the development of epidemiologic studies of workers 
exposed  to  engineered  nanoparticles”  J  Occup  Environ  Med.  2009  Mar;51(3):323-
35.. http://www.ncbi.nlm.nih.gov/pubmed/19225418  

-  Trout,  DB,  Schulte,  PA.,  “Medical  surveillance,  exposure  registries,  and 
epidemiologic  research  for  workers  exposed  to  nanomaterials”.  Toxicology.  2010 
Mar 10;269(2-3):128-35 

CANADA 

• 

• 

Institut  de  recherche  Robert-Sauvé  en  santé  et  en  sécurité  du  travail,  IRSST : 
“Engineered  Nanoparticles.  Current  Knowledge  about  OHS  Risks  and  Prevention 
Measures”. 
2010. 
Edition, 
Second 
http://osha.europa.eu/en/news/CAN-Engineered-Nanoparticles  

Environment Canada: Environment Canada issued a notice in early 2009, requiring 
companies  producing  nanomaterials  to  file  federal  reports  on  those  materials 
describing their toxicity, volume produced, and other relevant and readily available 
data.  This would be  required  for all  materials produced in quantities greater than 1 
kg.  Canada  also  plans  to  launch  a  voluntary  program  much  like  the  NMSP  in  the 
United 
http://www.ec.gc.ca/subsnouvelles-
newsubs/default.asp?lang=En&n=D179F162-1 . Also: “Guide for the Safe Handling 
Version: 
of 
http://www.ec.gc.ca/Publications/default.asp?lang=En&xml=F5DE8BCC-B2B9-
4BEB-BB6E-89628B233AE6  

Nanotechnology-based 

Products” 

States. 

2009 

- 

AUSTRALIA 

• 

• 

4. 

• 

Safe  Work  Australia:  “Engineered  nanomaterials:  Evidence  on  the  effectiveness  of 
workplace 
(2009): 
http://www.safeworkaustralia.gov.au/ABOUTSAFEWORKAUSTRALIA/WHATW
EDO/PUBLICATIONS/Pages/RR200911ENEvidenceOnEffectiveness.aspx  

exposure” 

controls 

prevent 

to 

Work  health  and  safety  assessment  tool  for  handling  engineered  nanomaterials  – 
2010, 
Australia, 
http://www.safeworkaustralia.gov.au/AboutSafeWorkAustralia/WhatWeDo/Publicati
ons/Pages/AT201008WorkHealthAndSafetyAssessmentTool.aspx 

Work 

Safe 

SPECIFIC EU PROJECTS 

Compendium  of  Projects  in  the  European  NanoSafety  Cluster:  The  projects 
appearing in this compendium are supported financially by the European Union and 
the Governments of the FP6 and FP7 Associated States. The Nanosafety cluster will 
.  2011 
be  coordinated  by 
edition:http://www.nanoimpactnet.eu/uploads/file/NanoSafetyCluster/Compendium_
2011_web.pdf, 
edition 
ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/compendium-nanosafety-
cluster2010_en.pdf  

the  Finnish  Institute  for  Occupational  Health 

2010 

EN 

86 

   EN 

• 

• 

• 

• 

• 

• 

5. 

• 

Nanodevice:  Novel  Concepts,  Methods,  and  Technologies  for  the  Production  of 
Portable,  Easy-to-use  Devices  for  the  Measurement  and  Analysis  of  Airborne 
Engineered 
Air 
http://www.ttl.fi/partner/nanodevice/Pages/default.aspx  

Nanoparticles 

Workplace 

in 

NANOSH:  exposure  and  health  effects  of  selected  nano-sized  particles  relevant  to 
the occupational environment: http://www.ttl.fi/partner/nanosh/Sivut/default.aspx  

NANOATLAS of selected engineered nanoparticles. The objective for the Nanoatlas 
is to present a representative series of selected nanomaterials including high volume 
nanomaterials in commercial applications. NANOATLAS can be used, e.g., for the 
detection and measurement of typical engineered nanoparticles in products, dusts and 
samples. 
tissue 
http://www.ttl.fi/partner/nanosh/progress/Documents/nanosh_nanoatlas.pdf  

Safe 

NanoSafe: 
nanomaterials: 
http://www.nanosafe.org/scripts/home/publigen/content/templates/show.asp?L=EN&
P=55&vTicker=alleza  

production 

and 

use 

of 

NANOGENOTOX:  Safety  evaluation  of  manufactured  nanomaterials  by 
characterisation 
hazard 
of 
http://osha.europa.eu/en/news/eu-nanogenotox 

genotoxic 

potential 

their 

Nanocap: acronym for “Nanotechnology Capacity Building NGOs”; Aim: to deepen 
the understanding of environmental, occupational health and safety risks and ethical 
aspects of nanotechnology, structure discussion between environmental NGOs, trade 
unions,  academic  researchers  and  other  stakeholders.  Health  and  Safety  section: 
http://www.nanocap.eu/Flex/Site/Page918c.html?SectionID=1785&Lang=UK  After 
2009  the  individual  participants  continued  their  nano-activities  and  communicated 
about this using their own channels (see Contact and partners).  

INTERNATIONAL 

nanotechnologies 
OECD 
http://www.oecd.org/department/0,3355,en_2649_37015404_1_1_1_1_1,00.html, 
incl.  OECD  Database  on  Research  into  the  Safety  of  Manufactured  Nanomaterials 
(http://www.oecd.org/document/26/0,3343,en_2649_37015404_42464730_1_1_1_1,
00.html)and Sponsorship Programme for the Testing of Manufactured Nanomaterials 
(http://www.oecd.org/document/47/0,3746,en_2649_37015404_41197295_1_1_1_1,
00.html)  

Website: 

Three OECD reports address workplace issues: 

• 

• 

“Comparison  of  Guidance  on  Selection  of  Skin  Protective  Equipment  and 
Respirators for Use in the Workplace: Manufactured Nanomaterials”. Series on 
the  Safety  of  Manufactured  Nanomaterials  Nr  12.  ENV/JM/MoONO 
(2009)17.: www.oecd.org/dataoecd/15/56/43289781.pdf  

“Report  of  an  OECD  Workshop  on  Exposure  Assessment  and  Exposure 
the  Safety  of 
Mitigation:  Manufactured  Nanomaterials”.  Series  on 

EN 

87 

   EN 

Manufactured 
Nanomaterials 
https://www.oecd.org/dataoecd/15/25/43290538.pdf 

13, 

Nr 

ENV/JM/MONO(2009)18: 

• 

"Emission  Assessment  for  Identification  of  Sources  and  Release  of  Airborne 
Manufactured  Nanomaterials  in  the  Workplace:  Compilation  of  Existing 
Guidance".  Series  on  the  Safety  of  Manufactured  Nanomaterials  Nr  11, 
ENV/JM/MONO(2009)16, 
https://www.oecd.org/dataoecd/15/60/43289645.pdf 

• 

GoodNanoGuide:  Collaboration  platform  with  information  on  workplace  risk 
assessment  and  management, 
types  of 
nanomaterials.  Sponsored  by,  among  others,  NIOSH,  IRSST,  International  Council 
of Nanotechnology: http://goodnanoguide.org/tiki-index.php?page=HomePage  

including  for  specific  sectors  and 

• 

Specific ISO standards:  

• 

• 

• 

• 

ISO/TR  12885:2008  “Health  and  safety  practices  in  occupational  settings 
relevant to nanotechnologies” (published) 

ISO/TR  13329  “Preparation  of  Material  Safety  Data  Sheet  (MSDS)”  (in 
preparation) 

ISO/TS  12901-1  “Guidance  on  safe  handling  and  disposal  of  manufactured 
nanomaterials” (in preparation) 

ISO/TS  12901-2  “Guidelines  for  occupational  risk  management  applied  to 
engineered  nanomaterials  based  on  a  "control  banding  approach"  (in 
preparation) 

•  More 

on 

standards 
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?c
ommid=381983 

nanotechnologies 

ISO 

the 

on 

at 

6. 

• 

OTHER STAKEHOLDERS´ACTIVITIES 

Nordic  Council of Ministers: “Evaluation and control of occupational health risks 
from  nanoparticles”,  2007.  Includes  an  overview  of  uses  and  manufacturing  of 
nanoparticles in the Nordic Countries, a review of methods for exposure and control 
measures,  occupational  exposure  scenarios  and  a  review  of  the  quality  of  Material 
Safety 
at: 
Sheets. 
http://www.norden.org/da/publikationer/publikationer/2007-
581/at_download/publicationfile  

Available 

Data 

• 

European Trade Union Confederation, ETUC:  

• 

adopted  a  second  resolution  on  Nanosciences  and  Nanotechnologies 
http://osha.europa.eu/en/news/eu-etuc-adopted-a-second-resolution-on-
nanosciences-and-nanotechnologies 

EN 

88 

   EN 

• 

to 

contributed 
http://osha.europa.eu/en/news/eu-etuc-contribution-to-the-definition-of-the-
term-2018nanomaterials2019  

definition 

term 

the 

the 

of 

‘nanomaterials’ 

• 

European Federation of Building and Wood Workers (EFBWW) and European 
Construction  Industry  Federation  (FIEC)  within  the  context  of  the  European 
Social dialogue: “Nano-products in the European Construction Industry – State of the 
art 
http://hesa.etui-
rehs.org/uk/newsevents/files/Nano_Executive_%20summary.pdf  

2009”, 

EN 

89 

   EN 

Appendix 7 
The JRC Nanohub database  

1. 

BACKGROUND AND SCOPE 

The  JRC  NANOhub  (http://www.nanohub.eu)  is  an  internationally  available  database  on 
nanomaterials with web-based access, hosted by the JRC. It has been developed on behalf of 
the JRC as a tool to address nano-safety and measurements of nanomaterials, supported by an 
international  stakeholder  network  from  academia,  industry,  Member  States,  ISO,  CEN, 
OECD,  and  NGOs.  The  JRC  NANOhub  hosts,  among  others,  data  and  studies  from  the 
OECD sponsorship programme on the testing of a representative set of nanomaterials, as well 
as  test  and  measurement  results  on  materials  from  the  JRC  Repository  of  Representative 
Nanomaterials. 

It serves the needs to: 

(1) 

(2) 

(3) 

Host information on nanomaterials in a structured way 

Manage  large  datasets  and  collect  multiple  study  reports  for  similar  nanomaterial 
endpoints 

Minimise  time  delays  for  information  search  and  exchange  to  further  enhance  co-
operations within research projects 

The JRC NANOhub database is set up to host datasets for specific materials (or substances). 
For  each  specific  material,  information  is  collected  in  chapters  and  sub-chapters  (or 
“endpoints”). The JRC NANOhub data structure builds on IUCLID chapters and the OECD 
Harmonised  Templates  (OHT).  These  IUCLID  sections  have  been  expanded  for 
nanomaterials-specific  endpoints 
the  OECD  WPMN  (Working  Party  for 
Manufactured Nanomaterials) in the Guidance Manual of the sponsorship programme. Once 
the  new  nanomaterials  sections  included  in  NANOhub  have  been  tested  and  finalised,  they 
will be submitted to the OECD for harmonization and implementation in a future release of 
IUCLID. Following such a  IUCLID  update the JRC NANOhub will be able to be based on 
IUCLID itself (if needed with using a custom configuration) so that further developments of 
IUCLID and IUCLID plug-ins could be used directly. 

listed  by 

JRC NANOhub provides features to address data quality, to create reports and dossiers, and to 
exchange data. It contains search functions and web-based access functionality and it provides 
collaborating  parties  with  a  frame  for  hosting  and  sharing  data.  This  way  it  facilitates 
cooperation between international parties using the World Wide Web.  

The  extent  to  which  data  are  collected  in JRC  NANOhub  (i.e.  the  “identification, gathering 
and upload” of data) now depends on the use, collection and exchange of data by, user groups, 
and  the  scientific  community.  The  data  format  of  JRC  NANOhub  does  not  constitute  a 
requirement  to  address  all  data  fields,  but  it  can  be  seen  as  comfortable  guidance  to  which 
data could contribute to gain an adequate picture of a nanomaterial. 

EN 

90 

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2. 

STRUCTURE 

The  present  JRC  NANOhub  structure  provides  the  frame  for  the  collection  of  nanomaterial 
data. It has three activity levels: 

(1) 

(2) 

(3) 

The  collaboration  through  a  project.  Each  project  and  its  collaborating  parties  use 
their  own  specific  and  independent  JRC  NANOhub  installation,  with  web-based 
access.  The  individual  JRC  NANOhub  installations  are  hosted  by  the  JRC.  Data 
exchange between different projects is an option. 

The material(s) investigated within the collaboration. Data regarding one, several or 
many  specific  materials  (substances)  are  collected  and  managed  in  the  JRC 
NANOhub installations as agreed within a collaboration. 

The  chapter  –  subchapter  (endpoint  /  endpoint  study)  structure  allows  entering 
and modifying data with regard to the specific material. 

Users access a project-specific installation from the www.nanohub.eu website (Figure 1). 

Figure 1: Structure of JRC NANOhub: projects hosted in February 2012 
The main chapters of the JRC NANOhub data structure are shown in Figure 2.  

0 

1 

2 

3 

4 

5 

6 

7 

8 

Related Information 

General information 

Classification and Labelling 

Manufacture, use and exposure 

Physical and chemical properties 

Environmental fate and pathways 

Ecotoxicological information 

Toxicological information 

Analytical methods 

EN 

91 

   EN 

 
9 

Residues in food and feedingstuff 

10  Effectiveness against target organisms 

11  Guidance on safe use 

12 

Literature search 

13  Assessment reports 

Figure 2: Structure of JRC NANOhub: Chapters 

Within  these  chapters,  the  templates  for  the  properties  (or  endpoints)  were  expanded  to 
include,  in  addition  to  OHTs,  new  templates  for  nanomaterials  taking  into  account  new 
physicochemical  endpoints,  such  as  aggregation/agglomeration,  zeta  potential  or  crystallite 
size,  as  well  as  in-vitro  toxicological  information.  An  example  for  this  format  is  shown  in 
Figure 3. 

Figure 3: Chapter 4: Physicochemical properties and nanomaterial 

3. 

FEATURES AND FUNCTIONS  

As  a  IUCLID  derivate,  JRC  NANOhub  is  designed  to  store,  maintain  and  exchange  data 
coming from research projects. This comprises features to: 

(1) 

(2) 

(3) 

(4) 

Define materials (substances), endpoint study records 

Enter, update and copy data (including copy-paste and use of clipboard) 

Query and view data 

Creation of dossiers for data exchange 

JRC NANOhub also includes IUCLID features on reporting and quality control: 

EN 

92 

   EN 

 
(1) 

(2) 

(3) 

Reporting  of  comprehensive  dossiers  with  selection  options,  e.g.  regarding 
confidential information 

Creation of dossiers 

Quality  control  including  track  changes,  data  comparison,  commenting,  reliability 
scores 

IUCLID features on administration, user management and data sharing are also available 
in JRC NANOhub: 

(1) 

(2) 

(3) 

Import, export functions  

Filtering and data selection 

Share  data,  dossier  submission,  compatible  with  other  programmes  (OECD, 
biocides) 

(4) 

User management and role management 

4. 

PROJECTS HOSTED TODAY 

A listing of hosted projects can be found on www.nanohub.eu. 

In particular, the OECD WPMN uses the JRC NANOhub to collect data from its sponsorship 
programme  on  safety  testing  of  a  representative  set  of  nanomaterials  until  a  version  of 
IUCLID is available where a range of nanomaterial specific endpoints has been implemented. 

5. 

DATA CONTENT 

Data obtained in the individual projects are hosted by JRC NANOhub. The data correspond to 
measurements and studies on materials from the OECD list of representative nanomaterials, 
from the European Repository of Representative Nanomaterials and other materials studied in 
the hosted projects.  

Data quality of individual study entries is reported in the study dataset. This would comprise 
e.g. “reliable without restrictions” for a test study performed under Good Laboratory Practice. 
Data  quality  scores  further  support  the  identification  of  key  studies  and  information,  when 
large datasets would be merged and several study reports are collected for similar endpoints.  

Several consortia have already decided to share all data; see www.nanohub.eu for an updated 
listing.  Data  today  are  entered  by  the  individual  parties  that  have  generated  the  data  or 
identified related information.  

6. 

DATA OWNERSHIP, DATA ACCESS AND USER MANAGEMENT 

The  JRC  provides  the  database  installation  and  related  service  on  request.  It  facilitates  the 
installation and maintenance of the respective JRC NANOhub installation for a collaborating 
consortium.  The  consortium  through  its  coordinator/representative  fully  decides  about  user 
access  and  use  of  content  including  sharing  of  information.  User  access  is  for  example 

EN 

93 

   EN 

managed  by  the  JRC,  and  fully  based  on  the  validation  of  requests  by  the  coordinator  of  a 
consortium. 

Contractual agreements regarding the terms of use within collaboration are dealt with by the 
consortium. Ownership and confidentiality of the data or the willingness to share specific data 
can be declared and are provided for. 

One free installation has been installed under ‘Open Science’, which provides any interested 
user with an area to explore the JRC NANOhub tools and features or to provide datasets to 
any other user or the scientific community. Access to this specific installation is granted to all 
registrants. 

7. 

FURTHER STEPS 

JRC  envisages  to  further  develop  the  JRC  NANOhub  application,  following  an  upcoming 
requirements capture exercise with key stakeholders depending on the available resources and 
according to an agreed development plan. In such a development project JRC NANOhub will 
use as a basis the future IUCLID version including nanomaterial endpoints and be embedded 
in an overall project structure that will encompass not only the full datasets, but also a viewer 
(to reduce perceived complexity) and a wrapper portal providing additional functionality.  

EN 

94 

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Appendix 8 
Existing product databases on, or with relevance to, consumer products 
containing nanomaterials 

1. 

REVIEW OF PRODUCT DATABASES 

This review is an edited and shortened version of chapter 3 of the report "Development of an 
inventory for consumer products containing nanomaterials" prepared by RIVM by order and 
for the account of the Commission.321  

It  includes  also  a  short  review  of  a  product  database  ("nanowerk")  not  considered  in  the 
RIVM report.  

This  annex  contains  a  review  on  inventories  described  in  product  databases  and  other 
databases linked to information on the use of nanotechnology and nanomaterials.  

Generally,  two  types  of  databases  dealing  with  nanomaterials/nanotechnology  can  be 
distinguished;  ‘product  databases’  and  ‘non-product  databases’.  Product  databases  can  give 
answers to questions about products containing nanomaterials , while questions about specific 
information on, for instance, the use of nanotechnology and nanomaterials in general, not in 
specific products, may be answered by ‘non-product’ databases. Both types of databases were 
studied in this review. 

2. 

EXISTING PRODUCT DATABASES 

The following items were considered for each database: 

– 

– 

– 

– 

– 

– 

– 

– 

What is the target group of the database? Who is going to visit and use the database?  

What is the method of gathering and selecting products?  

Are criteria defined for the inclusion of products in the database? 

How are the products categorised? 

What additional information is given on the database?  

How is the database documented and presented? 

Are there specific countries to which the database is focused? 

Are there any costs of using the database?  

These  points  will  be  discussed  below  for  every  database  provided  that  the  information  is 
available. 

The following existing product databases were investigated in the RIVM report:  

321 

http://ec.europa.eu/environment/chemicals/nanotech/pdf/study_inventory.pdf 

EN 

95 

   EN 

                                                 
(1) 

(2) 

(3) 

(4) 

(5) 

Woodrow Wilson database (“The Project on Emerging Nanotechnologies”) 

ANEC-BEUC  2010  inventory  of  consumer  products  containing  nanomaterials 
(ANEC-BEUC 2010) 

Online  database  of  German  Environmental  NGO  ‘BUND’  (Friends  of  the  Earth 
Germany) 

The Mintel Global New Products Database (GNPD)  

Household Products Database  

Databases 1 to 3 are nano-specific product databases while 4 and 5 are more general product 
databases. Concerning the Household Products Database (5), however, it turned out that the 
database did not have a function to find products with a nanoclaim and will not be considered 
further here. 

Below the first four product databases are described in more detail. 

2.1.  Woodrow Wilson database  

The American Woodrow Wilson database was the first publicly available on-line inventory of 
nanotechnology-based consumer products. The inventory claims to be an important resource 
for  consumers,  policymakers,  and  others  who  are  interested  in  learning  about  how 
nanotechnology is entering the market. Products have been selected for the Woodrow Wilson 
(WW)  database  by  systematic  web-based  searches.  These  have  ranged  from  exploratory 
searches, through searches on specific categories of goods, to following leads from multiple 
sources (including newspapers). 

According  to  the  database’s  website,  products  within  the  database  match  the  following 
criteria: 

– 

– 

– 

They can be readily purchased by consumers;  

They  are  identified  as  ‘nano-based’  (term  used  but  not  explained  by  Woodrow 
Wilson) by the manufacturer or by another source; 

The nano-based claims for the product appear reasonable.  

In every case, specific products from specific producers were identified.  

Products  are  categorised  in  the  following  main  categories  and  subcategories  (between 
brackets):  

– 

– 

– 

– 

Appliances (heating, cooling and air; large kitchen appliances; laundry and clothing 
care)  

Automotive (exterior; maintenance and accessories)  

Goods for Children (basics; toys and games)  

Electronics  and  Computers  (audio;  cameras  and  film;  computer  hardware;  display; 
mobile devices and communications; television; video)  

EN 

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   EN 

– 

– 

– 

– 

Food and Beverage (cooking; food; storage; supplements)  

Health  and  Fitness  (clothing;  cosmetics;  filtration;  personal  care;  sporting  goods; 
sunscreen)  

Home  and  Garden  (cleaning;  construction  materials;  home  furnishings;  luxury; 
paint)  

Cross-Cutting (coatings) 

However, since nanotechnology has broad applications in a variety of fields, also a number of 
‘generic’ products are included in the database that are found in many places on the market or 
produced by many manufacturers, such as computer processor chips.  

In  addition,  one  company  may  offer  several  similar  nanotechnology-based  products  and 
product lines. To avoid  redundancy,  for each company just a few samples were included in 
the WW database. This means that the database is not describing every product in a product 
line  but  that  it  provides  an  initial  baseline  for  understanding  how  nanotechnology  is  being 
commercialized. 

The information included for the products listed in the inventory is the following: information 
on the manufacturer, country of origin, product category, claims supporting the application of 
nanotechnology,  and  the  date  at  which  the  entry  was  last  updated.  Hyperlinks  to  the 
manufacturer’s website are also provided. 

No attempts were made to verify the nanoclaims of the products. This means that there may 
be  false  positives  in  the  inventory  (products  of  which  producers  claim  that  they  contain 
nanomaterials,  but  which  do  not).  Furthermore,  products  that  clearly  do  not  use 
nanotechnology have been avoided in this database, but some products have slipped through. 
For instance, GreenPan cooking utensils were mistakenly reported to have been manufactured 
using nanotechnology. This product has been removed from the database in September 2010. 
Additions to the inventory have been made periodically, as new information is received. Since 
the start of the project in 2005, the inventory has been updated six times. In the most recent 
update  of  10  March  2011,  303  new  products  have  been  added  since  the  latest  update  of 
August  2009.  In  the  Consumer  Products  Inventory  there  are  currently  1317  products, 
produced by 587 companies, located in 30 countries (as of 28 July 2011). 

For some products, their availability could no longer be ascertained; to indicate this they were 
marked  ‘Archive’.  At  the  time  these  products  were  added  to  the  inventory  ‘live’  links  were 
included. However, since then the company may have discontinued the product, gone out of 
business,  removed  a  self-identifying  ‘nano’  claim  or  simply  changed  their  web  address.  In 
these  instances  a  cached  version  of  the  product  website  was  located  using  The  Internet 
Archive with a date when the last update has taken place.  

database 

The 
website: 
presented 
http://www.nanotechproject.org/inventories/consumer/. Although the origin of the database is 
American, it is applicable for global use. Visiting the website is free of charge.  

the 

on 

is 

2.2. 

ANEC/BEUC 2010 inventory 

The  ANEC/BEUC  2010  inventory  is  a  European  inventory  of  products,  available  to 
consumers,  with  a  claim  to  contain  nanomaterials.  ANEC  and  BEUC  are  both  European 

EN 

97 

   EN 

consumers’ organisations (ANEC: European Association for the Co-ordination of Consumer 
Representation in Standardisation, BEUC: Bureau Européen des Unions de Consommateurs). 
The target group of the inventory is in principle consumers but the website claims that ‘it is 
also  useful  for  citizens,  policymakers,  and  others  who  are  interested  in  learning  about  how 
nanotechnology is entering the market’. Products were obtained via internet searches and/or 
using  the  feedback  of  member  organisations  of  ANEC  and  BEUC.  These  member 
organisations  searched  products  in  shops  or  at  trade  fairs,  or  found  them  when  they  tested 
them  in  their  consumer  tests  and/or  when  they  acted  in  response  to  requests  received  from 
consumers. 

Products within the ANEC/BEUC database have to meet two criteria: 

– 

– 

They claim to contain nanomaterials; 

They are available to European consumers. 

Several  product  categories  are  identified  which  are  of  relevance  to  consumers,  which  are 
based  on  the  categories  of  the  WW  database.  A  detailed  table  with  product  categories  is 
provided the following table. 

Category 

Sub-Category 

Appliances 

Kitchen Appliances 

Laundry/ Clothing Care 

Automotive 

Maintenance & Accessories 

Cross Cutting 

Coatings 

Others 

Electronic & Computers  No subcategory 

Food & Beverage 

Supplements 

Others 

Goods for Children 

No subcategory 

Health & Fitness 

Clothing 

Personal Care 

Sporting Goods 

Home and Garden 

Cleaning 

Construction Materials 

Others 

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Additional information on this inventory is that ANEC/BEUC has been able to check claims 
in  different  languages  since  the  member  organisations  are  located  in  different  European 
countries.  The  inventory  has  been  made  twice,  in  2009  and  in  2010.  The  update  has  been 
carried out in the same way as the initial inventory. The inventory is a Microsoft Excel table 
which is available via the BEUC website: www.beuc.org. The current inventory contains 475 
products. Visiting and using the inventory is free of charge. 

EN 

99 

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2.3. 

Online database of German Environmental NGO ‘BUND’ 

The  product  database  of  BUND  (acronym  for  Der  Bund  für  Umwelt  und  Naturschutz 
Deutschland) is focusing on consumer products claimed to contain nanomaterials in Germany. 
The target group of the website are ‘consumers and everyone else who is interested’. No clear 
information  is  given  on  the  website  on  how  the  products  are  obtained  and  which  selection 
criteria were used.  

The used categorisation for consumer products is presented in the following table. 

Category 

Auto 

Automotive 

Subcategory 

Autopflege (car maintenance) 

Fahrzeugbestandteile 
components) 

(car 

Elektronik und Computer 

Computer Hardware 

Electronics 
Computers 

and 

Freizeit 

Leisure 

Electronisches 
Pflegemittel 
(equipment and maintenance) 

Zubehör 

und 
Elektronik 

für 

Mobiltelefone (mobile phones) 

Reiseutensilien, Tassen und Koffer 
(travelequipment, 
and 
luggage) 

bags 

Sonstige (other) 

Sportgeräte  und  Zubehör  (sports 
equipment and accessories) 

Gesundheit 

Sonstige (other) 

Health 

Haus und Garten, Tiere 

Baumaterialien 
materials) 

(construction 

Home,Garden, 
(domestic) Animals 

and 

Farben und Lacke (paint) 

Gärtnern und Landwirtschaft 

Haustierzubehör  und-pflege  (pets 
equipment and maintenance) 

Möbel (Furniture) 

EN 

100 

   EN 

 
 
Wasch-, 
Pflegemittel 
coating products) 

Reinigungs- 
(Cleaning 

und 
and 

Große  Küchengeräte 
kitchen appliances) 

(Large 

Haushaltsgeräte 

Appliances 

Heizung, 
(Heating, Cooling and Air) 

Kühlung, 

Lüftung 

Kleingeräte (small appliances) 

Kochutensilien (cooking utensils) 

Sonstige (other) 

Körperpflege 

Kosmetika (cosmetics) 

Personal Care 

Lebensmittel 
Getränke 

Foods and Beverage 

Medizinische 
Anwendungen 

Medical Use 

Körperpflegeartikel  (personal  care 
products) 

und 

Kochutensilien (cooking utensils) 

Lebensmittelaufbewahrung 
package) 

(food 

Nahrungsergänzungsmittel 
supplements) 

(food 

Zuzatzstoffe 
Verarbeitungshilfen  

Medizinprodukte 
products) 

und 

(medical 

Produkte für Kinder  

Spielzeug (toys) 

Goods for Children 

Sonstige 

Other 

Textilien und Schuhe 

Textile and Shoes 

Beschichtungen  und  Pflegemittel 
für  mehrere  Anwendungsbreiche 
(coating for multiple purposes) 

Bekleidung 
(upholstery) 

und 

Wäsche 

Textil-  und  Schuhpflege  (Textile 
and shoe maintenance/ coating) 

EN 

101 

   EN 

The BUND database contains about 200 products (March 2011), but it is mentioned that more 
products  will  follow  shortly.  BUND  attempts  to  give  an  overview  of  products  that  are 
available in Germany, by giving a selection of products from different product categories. For 
further  extension  of  the  list,  the  cooperation  of  consumers  is  requested  to  bring  up  new 
products. Consumers (in Germany) are called to report all nanomaterial containing consumer 
products  that  are  found  in  shops  and  that  are  missing  in  the  database.  The  database  is 
accessible  on  the  website  of  BUND:  http://www.bund.net.  Using  the  database  is  free  of 
charge. 

2.4.  Mintel Global New Products Database (GNPD) 

The Global New Products Database (GNPD) of Mintel is a  general global product database 
with manufacturers, agencies and suppliers as primary target groups. GNPD claims that over 
20,000 new products are added every month, from 49 countries worldwide. Note that GNPD 
is  not  nano-specific,  so  it  is  not  specifically  focused  on  products  with  a  nanoclaim.  GNPD 
scans  the  product  labels  and  stores  this  information  in  their  database.  As  a  consequence, 
products with a nanoclaim can be selected. No specific criteria are mentioned for products to 
be  included  in  the  database.  Nevertheless  the  database  only  includes  products  that  can  be 
purchased 
link: 
http://www.gnpd.com/sinatra/gnpd/frontpage/&s_item=home. 

the  supermarket.  The  GNPD 

is  accessible  via 

the  following 

in 

To get information from the GNPD a paid license is required. 

A product database not considered in the report by RIVM is 

The Nanotechnology Products database of "nanowerk" 

Nanowerk.com  is  a  nanotechnology  and  nanosciences  portal  developed  and  maintained  by 
US-based  Nanowerk  LLC.  Its  Nanotechnology  Products  database  provides  an  overview  of 
how  nanomaterials  and  nanostructuring  applications  are  used  today  in  industrial  and 
commercial appplications across industries.  

The  database  is  presented  on  the  website:  http://www.nanowerk.com/products/products.php 
The  origin  of  the  database  is  American,  but  it  is  applicable  for  global  use.  The  criteria  for 
inclusion of products are not explicitly defined. Information is collected via web searches and 
by input from product manufacturers and consumers. 

It uses the categorisation: 

– 

– 

– 

– 

– 

– 

– 

Chemicals 

Commodities 

Construction 

Energy 

Environment 

Food 

Industrial 

EN 

102 

   EN 

– 

– 

– 

– 

– 

Information and Communications Technology 

Medical 

Precision Engineering 

Textiles and Garments 

Transportation 

The Nanotechnology Products database of nanowerk contains 177 products (July 2011), with 
information on the products provided by the product manufacturer, and includes links to the 
manufacturer's product web page.  

The database is public and visiting it is free of charge. 

3. 

THE REACH REGISTRATION DATABASE 

REACH322 is the European Union Regulation on chemicals and their safe use. It deals with 
the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemical  substances.  The 
Regulation entered into force on 1 June 2007. 

The  REACH  Regulation  places  greater  responsibility  on  industry  to  manage  the  risks  from 
chemicals and to provide safety information on the substances. Manufacturers and importers 
are required to gather information on the properties of their chemical substances, which will 
allow  their  safe  handling,  and  to  register  the  information  in  a  central  database  run  by  the 
European Chemicals Agency (ECHA) in Helsinki. The Agency acts as the central point in the 
REACH system and manages the REACH-IT database. 

REACH is specific for substances and it is possible to indicate that the registered substance is 
a  nanomaterial  or  includes  nanoforms  in  REACH  registrations  (for  example,  there  is  a 
voluntary tick-box to identify the substance or form of a substance as a nanomaterial). This 
information is retrievable from the registration database.323 It is however not always easy to 
identify  which  information  relates  to  the  nanoform(s)  and  which  information  to  the  bulk 
form(s) of the substances. Also, the description of uses in REACH dossiers is rather generic, 
and therefore it is not possible to identify concrete applications from the REACH dossiers. A 
screening  of  the  REACH  registration  dossiers  and  CLP  notifications  was  performed  to 
identify  information  about  substances  in  the  nanoform.  Methodology  and  outcome  of  this 
work is reported in Appendix 3. 

4. 

OTHER DATABASES LINKED TO THE USE OF NANOTECHNOLOGY 

In  addition  to  the  product  databases  discussed  above,  below  an  overview  is  presented  on 
databases  not  predominantly  considering  products,  but  containing  information  related  to  the 
potential toxicity or hazard of nanomaterials. Two of the databases mentioned in the current 

322 

323 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH),  OJ  L 
396, 30.12.2006, p. 1. 
http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances 

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section  provide  information  on  experimental  data  and  the  projects  and/or  organisations  in 
which these data are obtained. Two other databases specifically focus on industry needs. 

(1) 

(2) 

(3) 

(4) 

The OECD Database on Research into Safety of Manufactured Nanomaterials  

JRC NanoHub  

nanotech-data.com  

nanoproducts.de 

4.1. 

The OECD Database on Research into Safety of Manufactured Nanomaterials 

The  OECD  Database  on  Research  into  Safety  of  Manufactured  Nanomaterials  is  a  publicly 
available database of the Organisation for Economic Co-operation and Development (OECD). 

It is an inventory of safety research information on manufactured (engineered) nanomaterials. 
The  database  contains  information  relevant  to  research  on  the  environmental,  health,  and 
safety  aspects  of  nanomaterials.  The  information  is  and  will  be  based  on  projects  that  are 
planned, underway or completed. The details on the data on nanomaterials gathered in these 
projects  may  not  be  available  via  this  database  before  they  are  published  in  the  scientific 
literature.  

The  OECD  database  has  been  developed  as  part  of  the  OECD  activities  to  promote 
international  co-operation  in  addressing  human  health  and  environmental  safety  aspects  of 
manufactured nanomaterials. It is also intended to be an inventory of information on research 
programmes  to  help  other  projects  of  the  OECD  Working  Party  on  Manufactured 
Nanomaterials  (WPMN).  This  help  may  consist  of  identifying  relevant  research  projects  or 
storing  information  derived  from  the  projects  of  the  WPMN  (including  the  sponsorship 
programme on the testing of manufactured nanomaterials). 

The following information is stored in distinct fields:  

– 

– 

– 

– 

– 

– 

– 

– 

Project Title; Start date; End date;  

Project Status (Current; planned; or completed);  

Country or organisation;  

Funding  information  (where  available,  on  approximate  total  funding;  approximate 
annual funding; and funding source);  

Project Summary; Project URL; Related web links;  

Investigator information: name, research affiliation, contact details;  

Categorisation  by  material  name,  relevance  to  the  safety,  research  themes,  test 
methods;  

Overall outcomes and outputs of the project. 

The 

site 

is 

publicly 

and 

freely 

available 

via:

(http://webnet.oecd.org/NanoMaterials/Pagelet/Front/Default.aspx) 

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4.2. 

JRC NANOhub324  

The  JRC  NANOhub  is  a  comprehensive  IT  platform  (http://www.nanohub.eu),  dedicated  to 
the management of safety/risk assessment information of nanomaterials (substances). 

The  information  gathered  in  this  database  is  obtained  from  different  EU  projects  as  well  as 
various  OECD  WPMN  activities  (Sponsorship  programme  for 
testing  of  a set  of 
representative  nanomaterials).  The  database  consists  of  physicochemical  properties  and 
toxicity data of various engineered nanomaterials. These data are not publicly available. 

4.3. 

Nanotech-data.com 

Nanotech-data.com  is  the  Database  of  Nanotechnologies  for  Luxembourg  and  areas  in 
Germany  and  Belgium  (Luxembourg,  Lorraine,  Rhineland-Palatinate,  Saarland,  Wallonia). 
The  aim  of  the  database  is  to  inform  about  existing  products,  patents,  processes,  demands, 
news  and  events  in  the  field  of  nanotechnology  and  to  stimulate  the  knowledge  transfer 
between  research,  Small  to  Medium-sized  Enterprises  (SME’s)  and  large  companies.  The 
target public of this  website are  SME’s, firms, researchers, institutions and  individuals. The 
website  provides  detailed  information  about  existing  products,  methods  and  services, 
application of interactive internet tools, simple and efficient handling and it is free of charge. 
via 
The 
http://www.nanodaten.de/site/page_de_garde.html. 

available 

publicly 

freely 

and 

site 

is 

4.4. 

Nanoproducts.de  

The  website  nanoproducts.de  is  a  freely  accessible  internet  database  that  deals  with  the 
marketing  of  products  containing  nanomaterials  and/or  products  produced  with 
nanotechnology on the internet. According to the website ‘it offers services to industry in the 
area  of  product  and  technology  transfer’.  In  this  database,  more  than  450  different 
nanotechnology products are presented. The product spectrum comprises the fields of process 
engineering, analytics, raw materials, materials and commercial products. The aim is to list all 
technologies.  The  website 
commercial  and  non-commercial  nanotech  products  and 
http://nanoproducts.de/ is publicly available; using it is free of charge. 

324 

For more details, see Appendix 7. 

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Appendix 9 
Standardisation 

Standardisation is a process of consensus building on topics of technical-commercial nature, 
but  also  on  items  of  broader  societal  relevance,  in  order  to  improve  and  facilitate 
communication, trade, innovation and transfer of technology. One distinguishes 'documentary' 
or 'written' standards (see section 1.) from physical or material standards (see section 2.). Both 
written  and  physical  standards  play  an  important  role  in  harmonising  multiple  aspects  of 
society and our daily lives, increasingly also those aspects that are related to nanotechnology. 

1. 

DOCUMENTARY STANDARD DEVELOPMENT ACTIVITIES 

1.1. 

General overview of actors and activities in nanotechnology standardisation 

The  International  Organization  for  Standardization  (ISO)  is  the  larger  of  the  non-
governmental  standard  development  organisations  (SDOs)  and  provides  a  global  forum  for 
the  development  of  'documentary'  or  'written'  standards  (as  opposed  to  physical  or  material 
standards;  see  2.).  In  the  field  of  nanotechnologies,  the  ISO  Technical  Committee 
'Nanotechnologies'  (ISO/TC  229)  plays  a  central  role.  It  was  created  to  complement  and 
coordinate  the  nano-relevant  standardisation  work  already  undertaken  by  other,  older  ISO 
TCs. Similar responsibilities are carried by IEC/TC 113 and CEN/TC 352 in their respective 
mother SDOs (IEC,  the International  Electrotechnical  Commission, and CEN,  the European 
Committee for Standardization). Another major player in the nanotechnology standardisation 
area  is  the  Organisation  for  Economic  Cooperation  and  Development  (OECD),  which  has 
devoted  two  working  parties  to  the  topic  (Working  Party  on  Manufactured  Nanomaterials, 
WPMN,  and  Working  Party  on  Nanotechnology,  WPN).  There  are  also  a  number  of 
international  organisations  involved  in  the  measurement  aspects  of  standardisation,  such  as 
CIPM,  the  international  metrology  organisation,  or  VAMAS  (the  Versailles  project  on 
Advanced Materials and Standards), active in pre-normative research. 

To facilitate the coordination of the work of the different SDOs the Nanotechnologies Liaison 
Coordination  Group  (NLCG)  was  created  in  2008.  The  NLCG  is  hosted  by  ISO/TC 229. 
Twice a year, representatives of the NLCG members325 discuss issues of common interest, in 
order  to  improve  harmonisation  (for  example  of  terminology)  and  to  avoid  unnecessary 
duplication  in  a  time  where  resources  are  limited  and  in  an  area  where  expectations  from 
regulators and from the public are high. The agenda of the NLCG meetings is organised based 
on the periodic liaison reports submitted by the members.326  

Over  the  last  three  years,  since  the  publication  of  the  previous  EC  Regulatory  Review,  a 
number of specific nanotechnology standards and reports have been released, especially, but 
not  only,  by  ISO/TC  229.327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349 

325 

326 

327 

November  2011:  NLCG  counts  37  members,  including  ISO,  CEN,  IEC,  OECD  committees  and 
working parties, CIPM and VAMAS; the European Commission is represented through liaison officers 
from the EC Joint Research Centre (JRC)). 
The  6-monthly  liaison  reports  are  publicly  available  on  the  ISO/TC  229  livelink  website 
(http://isotc.iso.org/livelink/livelink/open/tc229). 
ISO/TS  10798:2011  'Nanotechnologies  –  Characterization  of  single-wall  carbon  nanotubes  using 
scanning electron microscopy and energy dispersive X-ray spectrometry analysis'. 

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Currently,  the  CEN/TC 352  activities  are  dominated  by  the  European  Commission 
standardisation  mandate  M461,  which  requires  the  development  of  standards  on  about  40 
different nanotechnology subjects. Since most of these 40 topics correspond to a number of 
documents, the size of this M461 mandate is unprecedented. For each of these items at least 
one  standardisation  committee  has  already  indicated  its  intention  to  contribute  to  the 
development of the required documents. This currently concerns 7 ISO TCs, 6 CEN TCs and 
1 IEC TC. While a number of the listed items in the mandate are already under development, 
work on the majority of items has yet to start. For some items this will require substantial pre-
normative  research,  with  an  as  large  as  possible  international  collaboration,  for  example 
through  organisations  such  as  VAMAS,  or  through  EU-funded  research  (via  CEN  and  the 
standardisation mandate, or directly via the Research funding programmes). Coordination of 
the M461 work will be carried out by CEN/TC 352. CEN/TC 352 and ISO/TC 229 co-operate 
through  the  Vienna  agreement.  This  agreement  is  an  important  tool  for  European 
standardisation  efforts  in  the  nanotechnology  area  because  the  jointly  developed  EN  ISO 
standards reconcile the desire of the EU legislator to refer to EU-wide adopted standards, with 
the preference of major EU Member States to develop the standards at the most international 
standardisation level possible (i.e. at ISO level). Until February 2012, CEN/TC 352 has only 

328 

329 

330 

331 
332 

333 
334 

335 

336 

337 

338 
339 

340 

341 

342 
343 

344 

345 

346 

347 
348 

349 

EN  ISO  10801:2010  'Nanotechnologies  –  Generation  of  metal  nanoparticles  for  inhalation  toxicity 
testing using the evaporation/condensation method'. 
EN  ISO  10808:2010  'Nanotechnologies  –  Characterization  of  nanoparticles  in  inhalation  exposure 
chambers for inhalation toxicity testing'. 
ISO/TS 10867:2010 'Nanotechnologies – Characterization of single-wall carbon nanotubes using near 
infrared photoluminescence spectroscopy'. 
ISO/TS 80004-1:2010 'Nanotechnologies – Vocabulary – Part 1: Core terms'.  
CEN  ISO/TS  27687:  2008  ‘Nanotechnologies  –  Terminology  and  definitions  for  nano-objects  – 
Nanoparticle, nanofibre and nanoplate’. 
ISO/TS 80004-3:2010 'Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects'. 
ISO/TS  80004-7:2011  '  Nanotechnologies  –  Vocabulary  –  Part  7:  Diagnostics  and  therapeutics  for 
healthcare'. 
EN ISO 29701: 2010 'Nanotechnologies – Endotoxin test on nanomaterial samples for in vitro systems 
– Limulus amebocyte lysate (LAL) test'. 
ISO/TS 11251:2010 ' Nanotechnologies – Characterization of volatile components in single-wall carbon 
nanotube samples using evolved gas analysis/gas chromatograph-mass spectrometry'. 
ISO/TR 12885: 2008 ‘Nanotechnologies – Health and safety practices in occupational settings relevant 
to nanotechnologies’.  
ISO/TR 13121:2011 'Nanotechnologies -- Nanomaterial risk evaluation'. 
ISO/TR  12802:2010  '  Nanotechnologies  –  Model  taxonomic  framework  for  use  in  developing 
vocabularies – Core concepts'. 
ISO/TR  11360:  2010  'Nanotechnologies  –  Methodology  for  the  classification  and  categorization  of 
nanomaterials'. 
ISO/TS  10868:2011  '  Nanotechnologies  --  Characterization  of  single-wall  carbon  nanotubes  using 
ultraviolet-visible-near infrared (UV-Vis-NIR) absorption spectroscopy'.  
ISO/TS 80004-4:2011 'Nanotechnologies – Vocabulary – Part 4: Nanostructured materials'. 
ISO/TS  11308:2011  'Nanotechnologies  --  Characterization  of  single-wall  carbon  nanotubes  using 
thermogravimetric analysis'. 
ISO/TS  11888:2011 
Mesoscopic shape factors'. 
ISO/TS  12805:2011  'Nanotechnologies  --  Materials  specifications  --  Guidance  on  specifying  nano-
objects'. 
ISO/TS 13278:2011 'Nanotechnologies -- Determination of elemental impurities in samples of carbon 
nanotubes using inductively coupled plasma mass spectrometry'. 
ISO/TS 80004-5:2011 'Nanotechnologies -- Vocabulary -- Part 5: Nano/bio interface'. 
IEC/PAS  62565-2-1  'Nanomanufacturing  -  Material  specifications  -  Part  2-1:  Single-wall  carbon 
nanotubes - Blank detail specification'. 
IEC 62624 Test methods for measurement of electrical properties of carbon nanotubes. 

'Nanotechnologies  --  Characterization  of  multiwall  carbon  nanotubes  -- 

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released  4  documents,  each  co-developed  with  ISO/TC  229,  under  the  Vienna  Agreement, 
with ISO lead. 

1.2. 

Standard terminology and nomenclature 

ISO and IEC have a joint working group (JWG1) for work on terminology and nomenclature. 
CEN has explicitly chosen to not develop a nanotechnology terminology of its own, but to use 
its  liaison  status  and  the  Vienna  Agreement  to  co-develop  the  ISO  terminology.  A  detailed 
analysis  of  the  ISO/IEC/CEN  terminology  related  to  nanomaterials  is  given  in  Appendix  1. 
The  core  elements  of  a  series  of  terminology  documents  (EN  ISO/IEC  80004-x)  have  been 
released over the last three years. Document 1 in this series (ISO/IEC TS 80004-1, released in 
2009)350 defines terms such as nanotechnology, nanoscience, nanoscale and nanomaterial.351 
The  first  terminology  document  published  by  ISO/TC  229,  the  EN ISO  TS  27687 
document,352 with the definition of the terms nano-object and nanoparticle, is currently under 
revision and will be released after revision as the ISO TS 80004-2 document. ISO TS 80004-3 
covers  the  carbon  nanomaterials  (such  as  carbon  nanotubes)353  and  ISO  TS  80004-4  deals 
with nanostructured materials.354 ISO TS 80004-5 is a document defining terms for use in the 
field of nanobiotechnology,355 and a number of similar terminology documents, specific for a 
certain  field  of  nanotechnology  (manufacturing,  medicine,  etc.)  are  under  development. 
Conveniently, the complete list of terms and definitions in these documents, and in all other 
ISO documents, can be consulted in the ISO Concepts Database (http://cdb.iso.org). 

Complementary to the work on terminology is  the work on nomenclature. ISO and IUPAC, 
the International Union for Pure and Applied Chemistry, have recently decided to join their 
forces on this subject, and to develop a nomenclature for nano-objects in IUPAC, with help of 
ISO/TC 229.  

1.3. 

Standard measurement methods 

Several technical committees (TCs), in particular ISO TC 24/SC 4 (Particle characterisation), 
ISO/TC 201 (Surface chemical analysis) and ISO/TC 202 (Microbeam analysis), have already 
in  the  past  developed  standardised  methods  for  measurements  at  what  is  now  called  the 
nanoscale. Naturally, this work continues in these committees. ISO/TC 229 and IEC/TC 113 
complement  (but  not  replace)  the  work  of  other  technical  committees  on  measurement 
methods not yet covered by other technical committees, for example on the characterisation of 
carbon  nanotubes  356,357,358,359,360,361,362,363,364  or  on  the  creation  of  reproducible  nanoparticle 
aerosols for inhalation toxicity testing.365,366  

350 
351 

352 

353 
354 
355 
356 

357 

358 

ISO TS 80004-1:2010 Nanotechnologies – Vocabulary – Part 1: Core terms. 
Some of these terms were used in the definition, for regulatory purposes, of the term nanomaterial by 
the EC.  
CEN  ISO/TS  27687:  2008  ‘Nanotechnologies  –  Terminology  and  definitions  for  nano-objects  – 
Nanoparticle, nanofibre and nanoplate’. 
ISO/TS 80004-3:2010 'Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects'. 
ISO TS 80004-4:2011 Nanotechnologies – Vocabulary – Part 4: Nanostructured Materials. 
ISO/TS 80004-5:2011 'Nanotechnologies -- Vocabulary -- Part 5: Nano/bio interface'. 
ISO/TS  10798:2011  'Nanotechnologies  –  Characterization  of  single-wall  carbon  nanotubes  using 
scanning electron microscopy and energy dispersive X-ray spectrometry analysis'. 
ISO/TS 10867:2010 'Nanotechnologies – Characterization of single-wall carbon nanotubes using near 
infrared photoluminescence spectroscopy'. 
ISO/TS 11251:2010 ' Nanotechnologies – Characterization of volatile components in single-wall carbon 
nanotube samples using evolved gas analysis/gas chromatograph-mass spectrometry'. 

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their  behaviour,  and 

The specific CEN output in this area is likely to increase due to the standardisation mandate 
M461.  This  mandate,  given  by  the  European  Commission  to  the  European  SDOs  (CEN, 
CENELEC  and  ETSI)  is  focused  on  the  areas  of  measurement  and  testing  tools  for  the 
characterisation  of  nanomaterials  and 
to 
nanomaterials,  complementing  work  carried  out  in  the  framework  of  OECD-WPMN  and  in 
the context of the implementation of REACH and CLP Regulations. Examples of mandated 
items for standardisation are methods for the detection, identification and quantification of the 
nanomaterial content of 'matrix materials', which can be consumer products (food, cosmetics, 
etc.),  but  also  environmental  materials  (soils,  water,  sludge,  etc.).  The  development  of  a 
comprehensive set of reliable methods for the detection of minute amounts of nanomaterials 
in  such  matrices  will  require  years  of  research.  This  work  has  started  already  in  projects 
supported  by  previous  and  current  EU  Framework  Programmes  for  Research  (for  example 
FP7 project NanoLyse). 

to  assess  exposure 

A  particular  set  of  measurement-related  deliverables  of  the  OECD  are  the  OECD  Test 
Guidelines, which are used to underpin the OECD Mutual Acceptance of Data (MAD) policy. 
MAD has been developed to relieve some of the burden of testing and assessing chemicals, 
and requires laboratories to implement Good Laboratory Practice (GLP). A similar concept is 
used  by  the  world  metrology  organisation  (CIPM)  which  has  developed  the  International 
System of Units (SI) and tools (such as the Mutual Recognition Arrangement, MRA) to make 
measurement  results  SI-traceable,  and  therefore  globally  comparable.  The  culture  of 
measurement laboratory accreditation, in accordance with, for example, ISO/IEC 17025,367 is 
slowly spreading into the nano-analysis area. 

1.4. 

Conclusions 

An  important  part  of  the  efforts  of  SDOs  such  as  ISO,  CEN,  IEC  and  OECD,  in  the 
nanotechnology  area,  is  aimed  at  describing  and  specifying  nanomaterials.  These  efforts 
should  allow  to  distinguish  and  categorise  different  types  of  nanomaterials,  based  on  new 
nanomaterial-specific  terminology  and  nomenclature,  and  to  develop  measurement  methods 
that allow one to verify the properties that are characteristic for one nanomaterial category or 
another. This approach should further enable moving from the 'case-by-case' approach in the 
assessment and evaluation of nanomaterials, which is limited, laborious and slow dealing with 
a limited number of materials, to a category approach, where  data obtained on one  material 
can be rightfully judged to be relevant for another more or less similar material. 

359 

360 

361 

362 

363 

364 
365 

366 

367 

'Nanotechnologies  --  Characterization  of  multiwall  carbon  nanotubes  -- 

ISO/TS  10868:2011  '  Nanotechnologies  --  Characterization  of  single-wall  carbon  nanotubes  using 
ultraviolet-visible-near infrared (UV-Vis-NIR) absorption spectroscopy'.  
ISO/TS  11308:2011  'Nanotechnologies  --  Characterization  of  single-wall  carbon  nanotubes  using 
thermogravimetric analysis'. 
ISO/TS  11888:2011 
Mesoscopic shape factors'. 
ISO/TS 13278:2011 'Nanotechnologies -- Determination of elemental impurities in samples of carbon 
nanotubes using inductively coupled plasma mass spectrometry'. 
IEC/PAS  62565-2-1  'Nanomanufacturing  -  Material  specifications  -  Part  2-1:  Single-wall  carbon 
nanotubes - Blank detail specification'. 
IEC 62624 Test methods for measurement of electrical properties of carbon nanotubes. 
EN  ISO  10801:2010  'Nanotechnologies  –  Generation  of  metal  nanoparticles  for  inhalation  toxicity 
testing using the evaporation/condensation method'. 
EN  ISO  10808:2010  'Nanotechnologies  –  Characterization  of  nanoparticles  in  inhalation  exposure 
chambers for inhalation toxicity testing'.  
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. 

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2. 

REFERENCE MATERIALS AND REPRESENTATIVE TEST MATERIALS 

In  the  field  of  measurement  and  testing,  the  aspect  of  quality  assurance  is  valued  more  and 
more.  Essential  tools  in  the  development  and  validation  of  reliable  test  methods  and  in  the 
establishment of quality control of routine measurement processes are reference materials and 
representative test materials. 

2.1. 

Reference materials 

Reference  materials  are  materials  which  are  carefully  analysed  for  one  or  more  of  their 
properties, and which carry the obtained information (typically assigned property values) in a 
way that it can be used in measurement processes. Performing measurements on CRMs, and 
comparing the measured values with the attributed traceable certified property values, is not 
the  only  way  for  a  laboratory  to  prove  its  proficiency,  but  it  is  certainly  the  most  time-
effective method, provided the appropriate CRM is available. The possibility to provide such 
proof  of  proficiency  is  essential  for  laboratories  that  are  required  to  produce  measurement 
results that will be compared against, for example, regulatory limits. 

In  the  last  three  years,  the  European  Commission,  via  its  Joint  Research  Centre,  has 
contributed  significantly  to  the  development  of  an  increasing  number  of  non-certified 
nanoscale reference materials, which are needed for method development, control charts and 
interlaboratory studies. A particular success was the release of a first colloidal silica certified 
reference  material  (CRM).  CRMs  have  certified  property  values,  which  are  needed for 
method  validation  and  proficiency  testing. The  ERM-FD100  colloidal  silica  has  certified 
property values for several equivalent diameters of the constituent silica particles.368 Current 
reference  material  development  is  working  on  more  complex  nanoparticulate  systems 
(bimodal,  polydisperse),  in  line  with  the  measurement  needs  imposed  by  the  new  EU 
nanomaterial definition. Another main RM producer active in the nano-field is NIST (USA), 
which  has  released  reference  materials  consisting  of  Au-nanoparticles  and  of  carbon 
nanotubes. 

2.2. 

Representative test materials 

The characterisation of a particular property for a reference material requires the availability 
of a validated test method to assess that property. In the field of nanotechnology, there are a 
large  number  of  newly  developed  test  methods  that  are  still  to  be  validated.  Also  the 
applicability of existing, validated test methods to nanomaterials is sometimes questioned. In 
this case, that is, in the absence of validated test methods, reliable property values cannot be 
assigned,  and  therefore  reference  materials  cannot  be  produced.  Nevertheless,  the  level  of 
consensus  about  the  applicability  of  certain  test  methods  can  be  increased  by  carrying  out 
experiments in different laboratories on a common set of test materials. In the OECD-WPMN 
sponsorship  programme  a  number  of  materials  has  been  selected  based  on  their 
representativity  for  the  commercially  available  (or  expected  to  be  available)  nanomaterials. 
These materials are used in the international interlaboratory evaluation of existing OECD test 
guidelines, 
the  so-called  Sponsorship  Programme  (see  section  5.4).  The  European 
Commission, via its JRC, has contributed to this programme by the development of a series 
(NM-xxx)  of  such  nanomaterials.  They  are  primarily  intended  for  the  participants  in  the 

368 

Certification of equivalent spherical diameters of silica nanoparticles in water, ERM-FD100, A. Braun, 
K.  Franks,  V.  Kestens,  G.  Roebben,  A.  Lamberty,  T.  Linsinger,  Report  EUR  24620  EN,  European 
Union, Luxembourg, ISBN 978-92-79-18676-9, 2011. 

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OECD-WPMN  sponsorship  programme,  but  samples  can  also  be  obtained  by  other 
(http://ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanomaterials-
researchers 
repository). 

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