Commission staff working document - Accompanying document to theCommunication from the Commission to theCouncil, the European Parliament and the European Economic and Social Committee - Nanosciences and Nanotechnologies: an action plan for Europe 2005-2009 - Second implementation report 2007-2009 {COM(2009)607 final}
Date: 2009-10-29
Institutions: European Commission
Subjects: EU financing, EU research policy, action programme, consumer protection, environmental protection, industrial policy, innovation, international cooperation, nanotechnology, research and development

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.10.2009 
SEC(2009)1468 

COMMISSION STAFF WORKING DOCUMENT 

Accompanying document to the 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE 
EUROPEAN PARLIAMENT AND THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE 

Nanosciences and Nanotechnologies: An action plan for Europe 2005-2009. Second 
Implementation Report 2007-2009 

{COM(2009)607 final} 

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COMMISSION STAFF WORKING DOCUMENT 

Accompanying document to the 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE 
EUROPEAN PARLIAMENT AND THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE 

Nanosciences and Nanotechnologies: An action plan for Europe 2005-2009. Second 
Implementation Report 2007-2009 

Nanotechnology1 has the potential to enhance quality of life and industrial competitiveness in 
Europe.  The  “integrated,  safe  and  responsible  approach”  proposed  by  the  European 
Commission  (EC)  in  20042  has  been  agreed  by  stakeholders  and  is  now  the  core  of  the 
European Union’s nanotechnology policy. The Nanotechnology Action Plan 2005-20093 has 
provided  an  impetus  for  a  variety  of  developments.  After  the  first  two  years  of  the  Action 
Plan, progress in almost every area was identified in the First Implementation Report.4 This 
report covers actions undertaken and progress made during 2007-2009 in relation to the key 
areas  identified  in  the  Action  Plan.  Where  appropriate,  for  the  sake  of  completeness  and 
continuity,  developments  in  preceding  years  are  included.  In  this  Staff  Working  Document 
detailed  information  on  progress  can  be  found,  while  the  Communication  to  which  it  is 
attached  outlines  the  key  developments  in  each  policy  area  of  the  Action  Plan,  identifies 
current  challenges,  and  draws  conclusions  relevant  to  the  future  European  nanotechnology 
policy.  This  document  follows  the  headings  of  the  Action  Plan  (apart  from  the  last  one,  on 
coordination,  which  is  dealt  with  only  in  the  Communication).  International  cooperation  is 
now an integral part of the Commission’s policy in all areas of the Action Plan, and is dealt 
with mainly under the respective policy areas. 

TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

RESEARCH................................................................................................................. 7 

R&D Funding............................................................................................................... 7 

R&D Domains............................................................................................................ 10 

1 

In  this  report,  “nanotechnology”  is  used  as  short  for  nanosciences  and  nanotechnologies.  Although 
several  definitions  exist,  as  a  working  definition  used  here,  nanotechnology  is  the  understanding  and 
control of matter and processes at the nanoscale, typically, but not exclusively, below 100 nanometres 
in  one  or  more  dimensions,  where  the  onset  of  size-dependent  phenomena  usually  enables  novel 
applications. 
2 
Towards a European Strategy for Nanotechnology, COM(2004)338; 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2004:0338:FIN:EN:PDF 
3 

Nanosciences and nanotechnologies: An action plan for Europe 2005-2009, COM(2005)243; hereafter 
“Action Plan”; 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2005:0243:FIN:EN:PDF 
4 

Nanosciences  and  Nanotechnologies:  An  action  plan  for  Europe  2005-2009.  First  Implementation 
Report 2005-2007, COM(2007)505; 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0505:FIN:EN:PDF 

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1.2.1.  Nanoelectronics.......................................................................................................... 10 

1.2.2.  Nanophotonics............................................................................................................ 12 

1.2.3.  Nanomedicine ............................................................................................................ 13 

1.2.3.1.  Diagnostics including medical imaging ..................................................................... 13 

1.2.3.2.  Targeted drug delivery ............................................................................................... 14 

1.2.3.3.  Regenerative medicine ............................................................................................... 15 

1.2.4.  Converging sciences and technologies; nanobiotechnology...................................... 16 

1.2.5.  Self-assembly and directed assembly......................................................................... 17 

1.2.6.  Tools for nanosciences and nanotechnologies ........................................................... 17 

1.2.7. 

Industrial applications, including pilot lines .............................................................. 18 

1.2.8.  Applications in energy and environment ................................................................... 20 

1.2.9.  Catalysts ..................................................................................................................... 21 

1.3. 

Research on health, safety and environmental issues (HSE) ..................................... 21 

1.3.1.  Characterisation, metrology and reference materials................................................. 23 

1.3.2.  Research on potential human health hazards ............................................................. 24 

1.3.2.1.  Alternatives to Animal Testing .................................................................................. 27 

1.3.3.  Research on potential exposure throughout the life cycle ......................................... 28 

1.3.4.  Research on potential ecotoxicity, environmental fate and behaviour ...................... 29 

1.3.5.  Research on life cycle assessment (LCA) of nanomaterials ...................................... 30 

1.3.6.  Sources of information on research on health, safety and environmental issues of 

nanomaterials ............................................................................................................. 30 

1.4. 

European Technology Platforms................................................................................ 31 

1.4.1.  European Nanoelectronics Initiative (ENIAC) .......................................................... 31 

1.4.2.  Photonics21 ETP........................................................................................................ 32 

1.4.3.  Nanomedicine ETP .................................................................................................... 32 

1.4.4.  Sustainable Chemistry (SusChem)............................................................................. 33 

1.4.5.  Micro- and Nano-Manufacturing (MINAM) ............................................................. 34 

1.4.6.  European Technology Platform on Industrial Safety (ETPIS) .................................. 34 

1.5. 

EuroNanoForum 2009................................................................................................ 35 

1.5.1.  Environmentally sustainable and energy-efficient industrial production .................. 35 

1.5.2.  Energy and environment ............................................................................................ 35 

1.5.3.  Nanotechnology for sustainable healthcare ............................................................... 36 

1.5.4.  Prospects for industrial nanotechnologies.................................................................. 36 

1.5.5.  Governance of nanotechnology.................................................................................. 36 

1.6. 

International Collaboration in Nanotechnology Research ......................................... 36 

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1.6.1.  EU-US collaboration on Environmental, Health and Safety Impacts (HSE) of 

engineered nanoparticles............................................................................................ 37 

1.6.2.  Collaboration with ICPC countries ............................................................................ 38 

1.6.3. 

International Dialogue on Responsible Development of Nanotechnology................ 39 

2. 

3. 

4. 

4.1. 

4.2. 

4.3. 

INFRASTRUCTURES .............................................................................................. 40 

HUMAN RESOURCES............................................................................................. 43 

INDUSTRIAL INNOVATION ................................................................................. 47 

General situation ........................................................................................................ 47 

General innovation policy applicable to nanotechnology.......................................... 48 

Opportunities in particular technology sectors .......................................................... 50 

4.3.1.  Nanomaterials for Electronics and Photonics ............................................................ 51 

4.3.2.  Nanomaterials for the Medical Sector........................................................................ 52 

4.3.3.  Nanomaterials for the Energy Sector ......................................................................... 53 

4.3.4.  Nanomaterials for the Environment Sector................................................................ 54 

4.3.5.  Nanomaterials for the Automotive Sector.................................................................. 54 

4.3.6.  Nanomaterials for the Aeronautics Sector ................................................................. 55 

4.3.7.  Nanomaterials for the Construction Sector ................................................................ 55 

4.3.8.  Nanomaterials for the Textile Sector ......................................................................... 56 

4.3.9.  Nanomaterials for the Cosmetics Sector .................................................................... 56 

4.3.10.  Nanomaterials for the Agriculture and Food Sector .................................................. 57 

4.4. 

Standardisation and Metrology .................................................................................. 58 

4.4.1. 

Introduction ................................................................................................................ 58 

4.4.2.  Research, Innovation and Standardisation, ................................................................ 58 

4.4.3.  Nanotechnology standards: New achievements and developments........................... 59 

4.4.4.  Plans for future standardisation activities: The CEN report to the Commission’s 

programming mandate and the Commission’s response............................................ 61 

4.4.5.  Metrology, pre- and co-normative research, and tools for measurement quality 

assurance .................................................................................................................... 63 

4.5. 

4.6. 

5. 

Patents ........................................................................................................................ 65 

OECD Working Party on Nanotechnology (WPN) ................................................... 65 

SOCIETAL DIMENSION ......................................................................................... 67 

5.1. 

Code of Conduct for responsible nanosciences and nanotechnologies research ....... 67 

Ethical issues.............................................................................................................. 68 
5.2. 
5.2.1.  Ethical issues in the 7th Framework Programme........................................................ 68 

5.2.2.  Promotion of Alternatives to Animal Testing............................................................ 69 

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5.2.3.  European Group on Ethics in Science and New Technologies (EGE) and UNESCO

.................................................................................................................................... 70 

5.3. 

Transparency and public engagement........................................................................ 70 

5.3.1.  Outreach Projects in FP7............................................................................................ 70 

5.3.2.  Commission workshops on communication and outreach......................................... 72 

5.3.3.  Commission information tools................................................................................... 72 

5.3.4.  Commission dialogues ............................................................................................... 72 

5.3.5.  Other dialogues and OECD........................................................................................ 73 

6. 

HEALTH, SAFETY, ENVIRONMENTAL AND CONSUMER PROTECTION ... 74 

6.1. 

Nanomaterials on the market ..................................................................................... 74 

6.1.1.  Nanomaterials in research and industrial use............................................................. 74 

6.1.2.  Nanomaterials in consumer products ......................................................................... 77 

6.1.3.  Regulatory reporting .................................................................................................. 78 

6.1.4.  Further work............................................................................................................... 79 

6.2. 

Regulation .................................................................................................................. 79 

6.2.1.  Regulatory Review..................................................................................................... 79 

6.2.2.  Sectoral developments ............................................................................................... 80 

6.3. 

6.4. 

Safety concerns associated with the use of nanomaterials......................................... 83 

Analysis of research on health, safety and environmental issues .............................. 84 

6.4.1.  Characterisation, metrology and reference materials................................................. 85 

6.4.2.  Potential human health hazards.................................................................................. 85 

6.4.3.  Potential exposure throughout the life cycle.............................................................. 86 

6.4.4.  Potential ecotoxicity, environmental fate and behaviour........................................... 87 

6.4.5.  Life cycle assessment (LCA) of nanomaterials ......................................................... 88 

6.5. 

Research on health, safety and environmental issues – Further priorities from a 
regulatory perspective ................................................................................................ 88 

6.5.1.  Measurement methods, reference materials and characterisation.............................. 89 

6.5.2.  Test methods for effects on human health ................................................................. 90 

6.5.3.  Test methods for environmental effects..................................................................... 91 

6.5.4.  Exposure information throughout the life cycle......................................................... 91 

6.5.5.  Life cycle Assessment (LCA) .................................................................................... 92 

6.5.6.  Exposure mitigation ................................................................................................... 92 

6.5.7.  Environmental fate ..................................................................................................... 93 

6.5.8.  Networking and Infrastructure ................................................................................... 94 

6.5.9.  Strategic and Structural Development Needs ............................................................ 94 

6.6. 

International cooperation – developing a common base of knowledge..................... 95 

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6.6.1.  OECD Working Party on Manufactured Nanomaterials (WPMN) ........................... 95 

6.6.2. 

International Organization for Standardization (ISO)................................................ 97 

6.6.3.  Cooperation on Implementation of Regulation.......................................................... 98 

7. 

INTERNATIONAL COOPERATION ...................................................................... 99 

Annex 1: Degree of fulfilment of Commission Actions in Nanotechnology Action Plan 2005-

2009.......................................................................................................................... 100 

Annex 2: Nanomaterials on the market.................................................................................. 104 

Annex 3: List of Acronyms .................................................................................................... 107 

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1. 

RESEARCH 

Bringing  together  public  and  private  organisations  across  Europe  to  perform  collaborative 
research and development (R&D) in nanotechnology is vital for the interdisciplinary approach 
often needed for nanotechnology, as well as for optimising resources. The Action Plan called 
for  nanotechnology  R&D  to  be  reinforced  and  coordinated,  and  also  for  synergy  with 
education  and  innovation  to  be  pursued,  in  order  to  generate  the  “triangle  of  knowledge” 
needed for the European Research Area of knowledge for growth. This is the general strategy 
pursued in the successive Research Framework Programmes (FPs).5 Given the diversity of the 
underlying scientific approaches and the applications in many different sectors, a wide range 
of  research  topics  have  been  pursued  in  the  last  five  years  or  so.  This  chapter  presents 
information  on  European  and  worldwide  funding;  describes  the  different  fields  of  research 
pursued,  including  the  research  on  risk  assessment;  and  links  this  work  to  industrial  needs 
identified by several European Technology Platforms relevant to nanotechnology. There are 
also sections on the results from the recent EuroNanoForum conference; and the international 
cooperation activities. The next two chapters, on infrastructures and human resources, present 
the complementary activities needed to support innovation. 

1.1. 

R&D Funding 

Support  for  nanotechnology  R&D  came  from  both the Framework Programmes and the EU 
Member  States,  with  particular  emphasis  on  coordination  of  policies,  programmes  and 
projects. Under the 6th Research Framework Programme (FP6, 2002-2006) funding of almost 
EUR  1.4  billion  was  provided  to  more  than  550  projects  in  nanotechnology.  By  way  of 
comparison, the EC contribution was about EUR 120 million in FP4 (1994-1998) and EUR 
220 million in FP5 (1998-2002). Over its lifetime, FP6 accounted for almost a third of total 
public expenditure on nanotechnology in Europe. 

Table 1 Nanotechnology research funding in FP6 (2003-2006) by thematic priority or activity 

FP6 Thematic 
Priority / 
Activity 

EU 
funding, 
M€  

 % of 
total 

NMP 

IST 

Marie Curie6 

Health7 

Infrastructures8 

NEST9 

575 

466 

161 

57 

40 

24 

41.9

33.9

11.7

4.2

2.9

1.7

5 

6 

7 
8 

Framework  Programmes  of  the  European  Community  for  research,  technological  development  and 
demonstration activities – general information at http://cordis.europa.eu/ 
Specific  programme  “Structuring  the  European  Research  Area”,  “Marie  Curie  Actions  -  Human 
resources and mobility” 
Thematic priority “Life sciences, genomics and biotechnology for health” 
Specific programme “Structuring the European Research Area”, “Research Infrastructures” 

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SME10 

Others 

17 

33 

1.2

2.4

TOTAL 

1,374 

100

The period 2007-2009, which is covered by the present report, coincided with the first three 
years of the 7th Research Framework Programme (FP7, 2007-2013). Whilst final figures for 
2009  are  not  available  at  the  time  of  writing,  the  Community  funding  committed  following 
calls in the first two years of FP7, 2007 and 2008, was EUR 1.1 billion. In a way analogous to 
FP6,  this  funding  came  from  a  number  of  different  themes,  with  the  dedicated  NMP  theme 
(Nanosciences,  Nanotechnologies,  Materials  and  new  Production  Technologies)  accounting 
for  just  over  50  %  and  the  ICT  theme  (Information  and  Communication  Technologies) 
accounting  for  a  further  20  %.11  Further  contributions  came  from  the  “People”  and  “Ideas” 
specific  programmes,  which  do  not  target  particular  areas  or  applications.12  As  predicted  in 
the  previous  implementation  report,  much  of  this  funding  came  from  the  cross-thematic 
approaches  developed  in  FP7,  as  nanotechnologies  have  an  interdisciplinary  and  enabling 
character  and  can  contribute  to  different  industrial  sectors  and  policy  objectives  in  health, 
food, environment, energy and transport. 

Table 2 Nanotechnology research funding in FP7 (2007-2008) by theme or programme 

FP7 Theme / 
Programme 

EU 
funding 
2007, M€ 

EU 
funding 
2008, M€ 

EU 
funding 
2007-08, 
M€ 

NMP 

ICT incl. FET13 

ENIAC14 

Marie Curie 
(People) 

ERC (Ideas) 

282 

148 

0 

74 

18 

314

26

32

51

61

596

174

32

125

79

9 

10 

11 

12 

13 
14 

Specific programme “Integrating and Strengthening the European Research Area”, “New and Emerging 
Science and Technology” 
Specific  programme  “Integrating  and  Strengthening  the  European  Research  Area”,  “Specific  SME 
activities” 
It should be noted that the overall figure and the share of ICT would have been higher, were it not for 
the fact that the ICT Work Programme did not include topics in nanoelectronics in 2008. 
Despite  the  fact  that  these  programmes  do  not  target  particular  areas  or  applications,  the  interest  in 
nanotechnology is such, that a sizeable share of the available funding, of the order of 10 %, is allocated 
to relevant projects following the proposal evaluations. This trend is expected to continue. 
Future and Emerging Technologies objective 
ENIAC  Joint  Undertaking  –  see  section  1.2.1;  the  figure  of  EUR  32  million  from  FP7  was 
complemented by a further EUR 58 million from the ENIAC Member States, bringing the total public 
funding to EUR 90 million. 

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Health 

Energy 

Infrastructures 

SME 

Food and 
biotechnology 

Science in 
society 

TOTAL 

23 

17 

1.5 

12 

0 

0 

14

20

27.7

7

2

37

37

29

19

2

1.3

1.3

576 

556

1,132

It is interesting to follow the evolution of industrial participation in nanotechnology projects 
supported  by  the  NMP  theme:  In  the  nanotechnology  projects  selected  in  the  period  2007-
2008,  industry  accounted  for  40  %  of  all  participations.15  As  was  reported  in  the  previous 
implementation  report,  the  industrial  participation  in  nanotechnology  projects  (within  the 
NMP  thematic  priority  of  FP6),  had  risen  from  18  %  in  2003-2004  to  37  %  in  2006.  This 
shows the gradually increasing interest of industry in the nanotechnology topics included in 
this  theme,  although  inevitably  this  is  still  lower  than  in  NMP  projects  that  do  not  involve 
nanotechnology  (where  industry  accounts  for  57  %  of  all  participations).  The  industrial 
participation  in  nanotechnology  projects  supported  by  the  ICT  theme,  which  on  the  whole 
addresses more mature applications, is higher. 

The  Commission  is  also  carrying  out  nanotechnology  research  directly,  through  its  Joint 
Research  Centre  (JRC).  The  JRC  activities  span  a  wide  range  of  nanotechnology  areas 
including nanotoxicology and potential environmental impact; metrology, standardisation and 
the  development  and  production  of  reference  materials;  environmental  remediation;  and,  in 
the energy area, hydrogen production and storage, and catalysts for fuel cells. 

Global  expenditure  on  nanotechnology  research,  both  public  and  private,  in  the  three-year 
period 2004-2006 was around EUR 24 billion. Europe accounted for more than a quarter of 
this  worldwide  total,  with  the  EU  funding  directly  accounting  for  5-6  %.  In  the  two-year 
period 2007-2008, the global expenditure reached EUR 25 billion. Europe still accounted for 
about one quarter of the worldwide total. However, in Europe, private funding accounted for 
only 40 % of the total, whereas in the world as a whole private funding was overtaking public 
funding (as of 2008). 

Table  3  Global  nanotechnology  research  funding  (public  and  private)  in  2005-2006  and 
2007-200816 

Billion € 

2005-2006 

2007-2008 

public 

private  TOTAL 

public 

private  TOTAL 

15 

16 

These  figures  refer  to  participation  in  individual  projects,  i.e.  counting  participations  of  the  same 
beneficiary in different projects cumulatively. 
For the purposes of an approximate global comparison, figures are given in EUR, using 2005 exchange 
rates. Sources: European Commission and Lux Research 

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EU 

US 

Japan 

Russia 

China 

Others 

3.4

2.8

1.5

1.9 

3.1 

2.4 

5.3

5.9

3.9

1.5

0.9 

2.4

3.8

2.6

2.7

0.8

0.8

1.5

2.5

4.1

4.4

0.3

1.1

6.3 

6.7 

7.1 

0.8 

1.1 

2.6 

TOTAL 

9.2

8.3 

17.5

12.2

12.4

24.6 

1.2. 

R&D Domains 

This  section  will  discuss  the  various  domains  of  nanotechnology,  that  is,  nanosciences  and 
nanotechnologies, which are currently addressed by EU-funded research projects. The aim is 
to  give  an  overview  of  each  domain,  outlining expectations,  challenges  and  some  results.  It 
should be noted that the rather broad domain of nanomaterials is dealt with under a number of 
more specific headings. In addition to the projects covered here, other funded  projects have 
addressed risk assessment (treated in the next section); and areas of policy such as outreach, 
ethics, innovation, metrology and coordination of selected activities (treated in other parts of 
this  report).  Finally,  projects  funded  by  the  “People”  and  “Ideas”  specific  programmes  are 
often  in  fundamental  nanosciences,  and  thus  complement  to  some  extent  the  application-
oriented  domains  described  here.  Also  complementing  the  domains  described  here  are  the 
activities of an FP6 ERA-NET and an FP7 ERA-NET Plus17 on nanosciences, NanoScience-
Europe,18 with a current consortium of 17 national funding agencies in 12 different countries. 

1.2.1.  Nanoelectronics 

Nanoelectronics refer to the application of nanotechnology to semiconductor components and 
highly  miniaturised  electronic  sub-systems,  and  their  integration  in  larger  products  and 
systems.  Semiconductors  have  enabled  the  digital  revolution  that  has  brought  huge 
productivity  gains  to  our  economy  and  improvements  in  our  quality  of  life.  Constant 
innovation  in  the  area,  together  with  a  strong  industrial  competition,  have  given  rise  to 
affordable, ever more powerful and energy-efficient computers and other digital devices, for 
the everyday use of all businesses and virtually all types of consumer. The pace of this digital 
revolution is still accelerating, enabling new applications in nearly every segment of the world 
economy, such as medical devices, photovoltaic energy generation, traffic management, and 
so on. 

Current devices are manufactured using 65 nm or 45 nm processes (this dimension being the 
average half-pitch of a memory cell). In this sense, nanoelectronics is merely the consequence 
of  the  evolutionary  path  of  microelectronics  into  the  nanoscale  domain.  Current  transistors 
still  do  not  fall  under  the  category  of  nanomaterials,  which  are  produced  by  manipulating 

17 

18 

The objective of the ERA-NET scheme is to support the coordination of national and regional research 
programmes. In the case of ERA-NET Plus, there is additional EU funding of a joint trans-national call, 
up to 1/3 of the total.  
http://www.nanoscience-europe.org/ 

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matter  at  the  atomic  scale.  On  the  other  hand,  the  properties  of  future  devices  may  well  be 
defined by interatomic interactions and quantum mechanical properties. 

The first generation of CMOS (complementary metal-oxide semiconductor) chips were based 
on a lithographic process with features inside the transistors of 10 micrometres or more. The 
chips in most products in use today have lateral features more than a hundred times smaller – 
just 90 nm or 65 nm, approximately a thousand times smaller than the width of a human hair. 
That may be small, but in the competitive semiconductor industry, where size is crucial, it is 
not small enough. 

A reduction in minimum feature size means more transistors per chip, more transistors means 
more computing and processing power, and more power means more performance and more 
functional  electronic  systems:  PCs,  mobile  phones,  vehicles,  satellites,  and  so  on.  And, 
because the processed silicon wafers out of which chips are made are increasingly expensive 
(setting  up  a  factory  to  produce  them  today  costs  EUR  3  billion),  smaller  dimensions  also 
make it possible to use fewer of them to do more, meaning that reductions in device cost can 
continue. 

The  continuous  miniaturisation  of  the  current  transistors  is  approaching  its  physical  limits, 
however,  and  disruptive  approaches  are  needed  to  maintain  this  trend.  Current  transistor 
candidates  for  future  technologies  are  significantly  different  from  traditional  transistors  and 
fall  entirely  within  the  realm  of  nanotechnology.  Some  of  these  candidates  include  hybrid 
molecular  and  semiconductor  electronics;  one-dimensional  nanotubes  and  nanowires;  and 
advanced  molecular  electronics.  Although  all  of  these  hold  promise  for  the  future,  they  are 
still under development and are unlikely to be used for manufacturing in the near future. 

In  2007  and  2008,  about  EUR  106  million  was  dedicated  to  R&D  projects  in  the  area  of 
nanoelectronics – this includes projects under the Future and Emerging Technologies (FET) 
objective. 

ENIAC  is  the  European  Technology  Platform  (ETP)  dealing  with  nanoelectronics.  It  is  a 
large-scale, application-driven initiative mobilising all European actors in this innovation- and 
technology-intensive  sector.  The  Commission  identified  nanoelectronics  as  a  strategic  area 
where  the  new  funding  mechanism  of  a  Joint  Technology  Initiative  (JTI)  could  be 
implemented.  The  ENIAC  Joint  Undertaking  (JU),  the  legal  instrument  implementing  the 
industry-oriented part of the Strategic Research Agenda (SRA) of the ENIAC ETP, is active 
since the beginning of 2007. The ENIAC JU has already launched two calls for proposals.19 
Following  the  first  call  in  2007,  eight  projects  are  already  underway  with  a  total  public 
funding of EUR 90 million (EU and Member States combined). The total public funding for 
the second call of 2009 was EUR 104 million. 

As  examples  of  EU-funded  research  projects 
in  nanoelectronics,  NanoCMOS  and 
PULLNANO are amongst the most significant in terms of research results. The NanoCMOS 
initiative, which ended in June 2006, developed the technology to create a 45 nm generation 
(or technology node) of chips. The follow-up project, PULLNANO, is currently working on 
developing nodes as small as 32 nm and even 22 nm.20 At that diminutive size, semiconductor 
manufacturing  is  continuing  to  test  Moore’s  Law,  a  prediction  made  by  Intel  co-founder 
Gordon E. Moore in 1965 that the number of transistors that can be cost-effectively placed on 
a chip will double approximately every two years. 

19 
20 

http://www.eniac.eu/web/calls/callforproposals.php 
http://www.pullnano.eu/ and http://www.nanocmos.ac.uk/ 

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Progress has been made in the resolution obtained in top-down structuring of nanoelectronics 
devices: 

–  Optical lithography methods – using 193 nm exposure wavelength with liquid immersion 
(water) and simultaneous application of double exposure – can produce features below 30 
nm. It is expected that so-called computational lithography can extend optical lithography 
even  down  to  20  nm  (from  design  to  mask  making  and  the  final  exposure  of  the  silicon 
wafer, all processes are optimised by numerical simulation of the individual steps). 

–  EUV  (extreme  ultraviolet)  lithography  –  using  13  nm  exposure  wavelength  –  can  bring 
resolution down to 10 nm or less; this could be extended by changing to even shorter EUV 
exposure wavelengths of 5 nm to 7 nm. 

–  Multi-e-beam maskless lithography is envisaged, with relatively high wafer throughputs (5 
to  10  wafers  per  hour).  This  has  the  advantage  of  avoiding  extremely  expensive  mask 
making,  which  is  of  interest  only  for  low  and  medium-volume  production  of  application 
driven  semiconductor  components  (rather  than  commodity  products).  Here  resolutions  in 
the 10 nm to 20 nm range have been demonstrated. Introduction into industry is expected 
in the next two to four years. 

Nanoimprint technology is not considered here, as it is limited to applications where only one 
mask level is sufficient to make a product (e.g. magnetic heads). The reason for this is that the 
template allows only a one-to-one pattern transfer in contact with the substrate. 

Extreme resolutions have been obtained recently with bottom-up techniques: 

–  Electron  Beam  Induced  Deposition  (EBID)  using  a  scanning  transmission  electron 
microscope  (STEM):  A  group  at  the  TU  Delft,  in  cooperation  with  Arizona  State 
University,  have  “written”  tungsten-containing  dots  with  an  average  diameter  of  1  nm, 
thereby setting a new world record and probably a limit for EBID. This method is based on 
surface adsorbed molecules which dissociate into volatile and non-volatile parts under the 
influence of an e-beam; the non-volatile parts stick to the substrate where they have been 
dissociated, while the volatile ones are pumped away. 

–  Molecular  self-assembly  using  DNA  nanotechnology,  e.g.  to  make  DNA  nanotubes.  The 
DNA is used as a structural material rather than as a carrier of genetic information, making 
this  an  example  of  nanobiotechnology.  Apart  from  flat  sheets,  arrays  have  been  made  to 
form hollow tubes of 4-20 nm in diameter. These DNA nanotubes are somewhat similar in 
size and shape to carbon nanotubes, but are more easily modified and connected to other 
structures. 

In  Europe,  there  are  four  main  regional  clusters  active  in  nanoelectronics.  These  clusters 
combine the expertise of companies, training centres and public or private research units in a 
given  geographical  area,  and  are  committed  to  generating  synergies  within  common 
innovation projects. These are in the areas of Grenoble (ST, CEA-LETI), Dresden (Infineon, 
AMD,  CNT)  and  the  Leuven-Eindhoven-Aachen  triangle  (NXP,  IMEC);  and  the  emerging 
Irish cluster around Intel Ireland. 

1.2.2.  Nanophotonics 

Photonics is used more and more in core as well as in access networks. Photonics is also an 
enabling  technology  that  exploits  advances  in  lasers,  light  sources,  fibres  and  detectors;  in 
materials (e.g. nanotubes, nanocrystals and organics); and in architectures and manufacturing 
processes (hybrid integration, silicon photonics and CMOS compatibility). It promises to play 
a  major  role  in  new  areas  such  as  energy  conservation  (e.g.  by  improving  photovoltaic  and 
lighting  efficiency),  medicine,  biology,  environment  and  safety.  The  possibility  to 

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manufacture structures at the nanoscale – well below the wavelength of light – will radically 
change  traditional  approaches,  by  exploiting  physical  effects  not  previously  accessible. 
Europe has strong and recognised R&D capabilities, as well as SMEs, in photonics. 

–  The MONA project (Merging Optics and Nanotechnologies) was launched in June 2005 to 
bridge  the  gap  between  photonics  and  nanotechnologies.  Its  ultimate  objective  was  the 
development  of  a  European  roadmap  for  nanophotonics.  This  roadmap  identifies  key 
nanomaterials  having  the  strongest  impact  for  nanophotonics  (such  as  quantum  dots  and 
wires) and also covers the integration of electronics and photonics. 

1.2.3.  Nanomedicine 

Nanomedicine is the application of nanotechnology to health. It can improve quality of life by 
enabling true preventive medicine and precisely targeted intervention, as well as regenerative 
therapy.  Nanomedicine  works  on  the  basis  of  producing  man-made  functional  structures 
matching  the  typical  size  of  natural  biological  elements,  to  achieve  more  effective  and 
specific  interactions.  This  approach  has  much  potential  for  breakthroughs  in  basic,  applied 
and  clinical  sciences,  leading  to  more  efficient  and  targeted  diagnosis,  treatment,  and 
monitoring  of  disease.  This  is  relevant  to  the  treatment  of  a  wide  variety  of  diseases  from 
cancer  to  diabetes;  cardiovascular,  immunological,  inflammatory,  musculoskeletal  and 
neurodegenerative disorders (Alzheimer’s and Parkinson’s diseases); and infectious diseases. 
It can moreover enhance competitiveness by creating jobs with high added value; and in the 
longer term by reducing social care costs and leading to affordable healthcare for an ageing 
population. 

The  Nanomedicine  ETP  has  identified  three  areas  of  industrial  priority  in  nanomedicine 
research:  diagnostics  including  medical  imaging;  targeted  drug  delivery;  and  regenerative 
medicine. These are described in separate sub-sections below. 

The NMP, Health and ICT themes are all involved in the funding of nanomedicine projects. 
EU funding for nanomedicine was around EUR 330 million in FP6 (2002 – 2006) and EUR 
280 million in the first two years of FP7 (2008-2009). 
There is also an ERA-NET in nanomedicine, EuroNanoMed,21 which serves as a platform to 
launch joint calls in nanomedicine, with the participation of 18 states and regions. The first 
joint call for transnational projects closed in September 2009. 

Ethical,  legal,  social,  and  regulatory  aspects  are  of  particular  importance  for  the  successful 
development  of  nanomedicine.  There  are  therefore  several  EU-funded  support  actions  to 
address these issues (e.g. NanoMed Round Table). 

Devices  and  nanomaterials  used  in  nanomedicine  need  to  be  biocompatible  and  their  fate 
needs to be known, both in vivo and ex vivo. In this respect, the toxicology of nanomaterials is 
also very important. 

1.2.3.1.  Diagnostics including medical imaging 

Diagnostic  technologies,  including  medical  imaging  based  on  nanotechnology,  have  the 
potential to permit earlier diagnosis and therapy for a wide range of diseases, reducing risks 
for the patient and allowing less severe and less costly treatment. The area can be divided into 
in vivo and in vitro diagnostics, the goal in both cases being to detect an evolving disease as 
early as possible, ultimately up to the point of detecting single cells or biomarkers indicating 
the onset of a disease. Of interest in the area of in vitro diagnostics is a trend towards “point-

21 

http://www.euronanomed.net/ 

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of-care” diagnostics, allowing a  sample to be analysed by the doctor or the patient, without 
the need for a central laboratory. 

Early  diagnostics  are  based  on  the  identification  of  disease-related  biomarkers,  which  could 
offer  an  earlier  and  more  personalised  assessment  before  the  onset  of  symptoms. 
Nanotechnology  can  help  achieve  early  diagnostics,  for  example  by  making  use  of  highly 
sensitive in vivo and in vitro tests capable of identifying disease-specific molecules present in 
a sample. 

In  connection  with  medical  imaging,  nanotechnology  allows  the  development  of  improved, 
targeted contrast agents providing a better identification of diseased tissues, for instance with 
X-ray or magnetic resonance imaging (MRI). Molecular imaging, based on the use of specific 
targeted  contrast  agents,  plays  a  crucial  role  in  the  non-invasive  localisation  of  a  disease, 
minimising discomfort and pain for the patient. 

Related  to  diagnostics,  is  the  idea  of  targeting  the  therapy  to  a  biological  function  which  is 
specifically  altered  in  a  certain  disease  (often  called  “theranostics”).  With  this  strategy,  the 
tissue  of  interest  can  firstly  be  imaged,  using  target-specific  contrast  nanopharmaceuticals. 
Then, combined with further pharmacologically active agents, or with other stimuli (e.g. laser 
light), the same targeting strategy can be used for applying the appropriate therapy. Finally, 
the monitoring of the effects of treatment is possible by further sequential imaging. 

Examples of relevant projects include: 

VIBRANT:  Around  30  million  people  in  Europe  currently  suffer  from  diabetes,  with  an 
incidence of 7.5 % in Member States. This devastating disease is ranked among the leading 
causes of fatal cardiovascular diseases, kidney failure, neuropathy, lower limb amputation and 
blindness.  At  present,  no  clinically  established  methodology  exists  for  non-invasive  in  vivo 
imaging and quantification of insulin-producing beta-cells in the pancreas, whose dysfunction 
is responsible for diabetes. VIBRANT proposes a new nanotechnology-based method for the 
MRI  imaging  of  beta-cells.  Furthermore,  target-specific  drug-loaded  nano-containers  will 
offer high potential for cell-directed therapies. 

CAREMAN:  Diagnostic  devices  based  on  biosensor  technology  coupled  with  detection 
capabilities  and  integrated  sample  handling  aim  to  tackle  the  most  common  diagnostic 
problems  currently  faced  in  EU  hospitals  –  such  as  cardiovascular  diseases,  coagulation 
disorders,  chronic  and  acute  inflammation,  cancer  and  thyroid  disorders.  The  innovative 
solutions  that  these  devices  introduce  may  lead  to  the  eventual  replacement  of  traditional 
diagnostic techniques. 

1.2.3.2.  Targeted drug delivery 

Targeted  drug  delivery  systems  selectively  transport  drugs  to  diseased  cells  and  tissue, 
thereby  minimising  the  negative  side-effects  of  these  drugs  in  other  areas  of  the  body. 
Effective drug delivery is one of the biggest challenges in pharmaceutical research. 

Therapeutic  entities  can  be  small  molecules,  but  also  proteins,  antibodies,  nucleic  acids, 
antigens, peptide mimics, and so on.  Delivery systems should have a significant therapeutic 
payload. The efficient administration of a compound relies on the ability to reach the intended 
target,  for  example  to  cross  the  blood-brain  barrier  in  treating  neurological  diseases.  The 
method  of  administration  is  also  important,  as  it  plays  an  important  role  on  biodistribution, 
exposure, safety and efficacy. 

A  range  of  emerging  technologies  address  delivery  needs,  for  example  the  encapsulation  of 
the active compound in functionalised nano-vectors, or the external direction and release of a 

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drug using magnetic nanoparticles. In all cases, the target must be identified by discovering 
and validating new biomarkers on the basis of molecular recognition. 

Nanopharmaceuticals  and  nanodevices  can  also  be  activated  by  external  means  (magnetic 
resonance imaging, focused ultrasound, radiotherapy or lasers), in order to deliver an intended 
physical effect in a localised or systematic way. This effect could be heat or radiation to kill 
tumour cells. Alternatively, the external means can be used for the localised release of a drug 
at predetermined levels. 

Examples of relevant projects include: 

ASMENA: The development of new medicinal products is currently hindered by difficulties 
related  to  the  reliability  and  efficiency  of  screening  membrane  proteins  as  candidate  drug 
targets, despite their constituting more than 50 % of all drug targets. A new nanotechnology, 
combining  nano-porous  substrates  and  proteoliposome  self-assembly,  promises  to  deliver  a 
sensor  chip  to  quantify  screening  assays  of  drug  candidates  that  may  be  suitable  for 
commercial application. 

SONODRUGS:  By  allowing  drugs  to  be  delivered  to  disease  sites  via  the  patient’s 
bloodstream  and  then  activated  by  focused  ultrasound  pulses,  the  project  aims  to  maximise 
the  therapeutic  efficiency  and  minimise  the  side  effects  of  drug  treatments  for  cancer  and 
cardiovascular  disease.  The  project’s  research  on  MRI-guided  drug  delivery  will  focus  on 
potential treatments for cancer. It aims to develop MRI techniques that simultaneously image 
the patient’s anatomy, detect the arrival of MRI-labelled drug-loaded particles at the disease 
site, measure the local heating effect of the ultrasound pulses, and monitor the temperature-
triggered release of drugs from the particles. 

NANOEAR:  This  project  aims  to  develop  therapies  for  inner  ear  disorders,  using  novel 
multifunctional  nanoparticles  that  are  targetable  to  selected  cell  populations  for  controllable 
drug release. 

1.2.3.3.  Regenerative medicine 

A broad definition of regenerative medicine includes the repair, replacement and regeneration 
of  damaged  tissues  or  organs  (e.g.  skin,  muscle,  nerves,  cardiac  tissue  etc),  with  the  use  of 
approaches  that  can  roughly  be  divided  into  two  overlapping  areas:  smart  biomaterials  and 
advanced  cell  therapy.  Therapies  based  on  tissue  engineering  represent  a  breakthrough  in 
regenerative  medicine,  through  the  use  of  intelligent  biomaterials,  smart  implants,  and  cell-
based techniques. 

The focus of regenerative medicine is to stimulate tissue regeneration and repair by using the 
body’s  self-repair  mechanisms.  This  process  can  use  adult,  endogenous  stem  cells.  Smart 
nanostructured  or  nanopatterned  biomaterials  can  serve  as  scaffolds,  stimulating  the 
regeneration  process  by  providing  the  necessary  signalling  molecules  to  the  cells  to  start 
regenerating a particular tissue. 

Examples of relevant projects include: 

NANOSCALE:  Understanding  the  physical  and  chemical  events  at  the  nanoscale,  which 
occur  during  the  interaction  of  several  cell  types  (including  neurons  and  stem  cells)  with 
nanostructures,  is  of  paramount  importance  for  the  fabrication  of  biocompatible  surfaces  to 
induce stem cell proliferation and differentiation, and to guide neuronal growth. 

TEM-PLANT: This project aims to use hierarchical structures that naturally exist in plants, to 
generate  innovative  biomedical  devices  designed  for  bone  and  ligament  substitution.  This 

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leads  to  the  development  of  intricate  but  extremely  functional  architectures,  which  are 
constantly able to adapt to ever-changing mechanical needs. 

1.2.4.  Converging sciences and technologies; nanobiotechnology 

Nanobiotechnology is a broad field of knowledge and techniques, involving the convergence 
between  nanotechnology  and  the  basic  components  of  life:  proteins,  DNA  and  cells.  The 
interface  of  these  fields  has  the  potential  to  provide  revolutionary  scientific  and  technical 
approaches  to  address  existing  and  new  applications.  This  large  domain  has  inevitable 
overlaps  with  other  domains  discussed  in  this  section,  particularly  with  nanomedicine  and 
self-assembly. 

Nanobiotechnology is based on the fact that biological systems and processes within the cell 
operate at the nanoscale. Functional biological units, such as proteins, are to be found at the 
nanoscale;  while  cells  are  much  larger,  at  10  to  100  micrometres.  One  striking  fact  about 
biology is that organisms are built following the bottom-up approach. For instance, proteins 
are  built  by  putting  together  molecular  building  blocks  called  amino-acids,  according  to  a 
“plan” encoded in the DNA of the cell. Amongst the most innovative nanomedicines currently 
under development are nanostructures functioning as release systems for completely synthetic 
oligonucleotides. 

Like  nanotechnology,  nanobiotechnology  is  a  strongly  interdisciplinary  field  (the  term 
bionanotechnology is often used in the same sense). It includes two approaches: On the one 
hand,  we  try  to  learn  about  nature,  so  that  we  gain  insight  into  biological  processes,  which 
have  very  important  applications  in  medicine  (nanomedicine)  and  biotechnology  (food, 
industrial applications and environmental monitoring). On the other hand, we try to learn from 
nature, so that we can build useful systems at the nanoscale, using processes similar to those 
optimised  by  nature  over  millions  of  years.  Contrary  to  popular  belief,  it  is  impossible  to 
make  conventional  machines  at  the  nanoscale,  for  a  number  of  fundamental  reasons. 
Nevertheless, one can build nanostructures and “devices” of certain kinds by imitating nature. 

Molecular  motors  could  eventually  be  built  using  certain  biological  molecules  as  building 
blocks.  These  could  be  used  to  make  sorting  devices  for  molecules,  or  in  developing 
the  Hy3M  project  (Hydrogen-bond  geared 
nanoscale  manufacturing.  For  example, 
Mechanically Interlocked Molecular Motors) created new types of synthetic molecular motors 
–  fuelled  by  energy  in  the  form  of  light,  heat  or  electrons  –  which  transmit  the  effects  of 
mechanical motion from the molecular level through to the macroscopic world. 

Nanobiotechnology  is  expected  to  provide  innovative  tools,  for  example,  sensors  to  analyse 
biological  samples;  label  and  track  single  molecules  or  trace  elements;  and  improve  the 
fabrication of novel nanostructured materials (biomimetic materials), leading in turn to better 
fuel cells, solar cells and filtration membranes. 

As  discussed  in  the  relevant  sub-section  above,  developments  in  nanobiotechnology  can  be 
brought together in the field of nanomedicine, the application of nanobiotechnology to health. 
Another  emerging  area  of  relevance  for  nanomedicine  is  the  convergence  of  biological, 
information and cognitive sciences. One example is the interface between nanoscale systems, 
neurons and the brain, which is important for the development of intelligent brain-controlled 
prostheses, such as arms, legs, hands, ears and eyes. Even though this area is not considered to 
be of immediate industrial relevance, it has been addressed by some EU-funded projects (e.g. 
NEURONANO, SMARTHAND, DREAMS and NANOBIOTACT). 

The  2009  Work  Programmes  of  KBBE  (biotechnology  and  food)  and  NMP  included  five 
coordinated topics on nanobiotechnology, which were met with an excellent response: Smart 
devices  to  study  biomolecular  dynamics  in  real  time;  functionalised  membranes;  bio-

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interfaces  for  environmental  applications;  applying  life  science  principles  as  model  for  new 
nanotechnology-based mechanisms, processes, devices or systems; and analysis of the ethical, 
safety, regulatory and socio-economic aspects. 

1.2.5. 

Self-assembly and directed assembly 

A  large  and  diverse  area  of  research  involves  the  development  of  nanostructures  with 
controlled  physical  properties.  Such  nanostructures  can  have  a  significant  impact  in  energy 
and  environmental  applications,  nanoelectronics  and  photonics,  nanomedicine,  catalysts  for 
the chemical and pharmaceutical industry, and so on. Environmentally sustainable growth can 
result from a more efficient use of materials and energy, and from cleaner transport. 

Self-assembly  essentially  involves  interactions  at  a  higher  level  and  lower  strength  than 
standard chemical bonds, forming structures with an ordering beyond that of their individual 
components,  i.e.  nanostructures.  Closely  related  to  self-assembly  is  the  concept  of  self-
organisation. One can distinguish between processes where the building blocks carry specific 
information  directing  the  self-assembly  through  recognition;  and  processes  based  on 
templated growth methods, where building blocks are deposited onto pre-patterned substrates 
and their assembly is directed by the pre-existing pattern. These processes may in addition be 
assisted  by  external  factors  such  as  electromagnetic  fields,  fluid  flow  or  other  boundary 
conditions. 

Directed  self-assembly,  frequently  combined  with  more  traditional  “top-down”  approaches, 
allows  one  to  create  nanostructures  with  a  set  of  desired  and  controllable  properties.  The 
control  of  the  process  and  the  characterisation  of  the  resulting  structures  are  the  usual 
challenges in this field. In the longer term, it is desirable to find ways of  “up-scaling” such 
processes, to make them industrially relevant. In addition to scale, uniformity is an important 
consideration in up-scaling. Several projects have been or are being funded in this broad area, 
with  mixed  results:  Often,  the  particular  applications  pursued  by  a  project  turn  out  to  be 
impossible;  on  the  other  hand,  valuable  new  methods  for  the  synthesis,  modelling  and 
characterisation of materials are being developed. The industrial participation in such projects 
has tended to be peripheral, but is growing. 

Projects  currently  selected  for  funding  in  this  area  generally  have  an  increased  focus  on 
realistic applications, although the production scale remains a challenge. In 2009, this activity 
was complemented by a call topic on molecular manufacturing, that is, engineering functional 
structures  at  the  molecular  scale  to  achieve  sub-micro,  micro-  or  macro-scale  objects, 
possessing controlled properties over multiple scales. An important aim of this topic was to 
stimulate  the  industrial  take-up  of  novel  nanotechnology-based  solutions  within  existing  or 
new production lines. 

1.2.6.  Tools for nanosciences and nanotechnologies 

While  nanoscience  is  not  entirely  new,  since  the  invention  of  the  Scanning  Tunnelling 
Microscope (STM) and the Atomic Force Microscope (AFM) in the 1980s, researchers have 
developed increasingly powerful techniques for “seeing” and controlling objects, surfaces and 
structures at the nanoscale. Most applications in nanotechnology discussed elsewhere in this 
section  became  possible  after  that,  highlighting  the  importance  of  developing  appropriate 
instruments  for  material  characterisation.  Furthermore,  the  development  of  instruments  is  in 
itself an important area of innovation, especially for SMEs. 

Researchers continue to develop techniques to measure and characterise novel materials and 
effects at the nanoscale. Several projects funded under FP6, as well as in the first calls of FP7, 
have addressed this area. Relevant topics included “Pilot lines to study, develop and up-scale 
for 
nanotechnology-based  processes 

laboratory”;  “Equipment  and  methods 

from 

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nanotechnology”; “Specific, easy-to-use portable devices for measurement and analysis”; and 
“Pilot  lines  to  introduce  nanotechnology-based  processes  into  the  value  chain  of  existing 
industries”. 

The Nanobeams Network of Excellence concentrated on analytical techniques using focused 
ion and electron beams in order to develop analytical techniques and instruments matching the 
requirements  of  nanomaterials.  This  network  combined  the  efforts  of  manufacturers  of 
scientific instruments with those of leading research laboratories in the field. 

Relevant  projects  selected  under  FP7  include  several  examples  where  combinations  of 
atomic-scale characterisation technologies introduce new capabilities, such as the following: 

–  3D NanoChemiscope: 3-dimensional chemical characterisation of nanostructured inorganic 
and  organic  materials  with  lateral  resolution down  to  10  nm  or  less  and  depth  resolution 
down to 1 nm; 

–  FIBLYS: Probing of electron-matter interactions, e.g. detection of electron-beam induced 
current, or cathodoluminescence phonons, or backscattered electrons directly at the surface 
– with nanoscale resolution; 

–  MDSPM: Imaging of metallic, semiconducting and insulating surfaces with unprecedented 
resolution, expected to improve our understanding of entire areas of surface science such 
as chemical reaction dynamics, local energy dissipation and excitations, nanoscale contacts 
and a rational approach to catalyst design, to name a few; 

–  SMW:  Combining  three  advanced  microscopic  techniques  into  a  single  workstation  for 
reaching a new quality level in the study of the correlation between structure and function 
of living cells, with applications in immunology and cancer research; and 

–  Nano DNA sequencing: Sequencing of single molecules of genomic DNA in a number of 
hours,  much  faster  than  current  conventional  techniques,  and  possibly  detection  of 
different types of DNA based on their electrical properties. 

Inspection  and  monitoring  systems  for  security  is  another  important  area  addressed, 
exemplified by current research projects: 

–  TeraEye:  Scanning  systems  detecting  harmful  materials  based  on  passive  THz  detection, 

supporting a radical transformation in the security sector; and 

–  Dinamics:  Nano-biological  sensing  for  detection  of  biological  threats,  and  environmental 

assays using a lab-on-a-chip device that will be able to detect pathogens in water. 

1.2.7. 

Industrial applications, including pilot lines 

Significant  investments  have  been  made  throughout  FP6  in  long-term  research  in  various 
fields  of  nanoscience.  In  many  cases,  these  projects  have  produced  results  in  the  laboratory 
environment  (for  example  in  terms  of  desired  properties),  but  the  transfer  of  promising 
nanotechnology research results into new industrial technologies still represents a bottleneck. 

In  order  to  accelerate  the  introduction  of  nanotechnolgy-based  products  into  markets  and  to 
stimulate  the  development  of  the  European  nanotechnology  industry,  the  NMP  theme  has 
invited proposals for “Nanotechnology Pilot Lines” in the first two calls of FP7. The projects 
are  expected  to  focus  on  the  development  of  innovative  nanotechnology-based  processes  to 
pilot-line  scales,  in  order  to  improve  industrial  processes  and  production  lines.  The  projects 
are  also  expected  to  demonstrate  how  nanotechnology  can  significantly  improve  the  value-
chain  in  industrial  production  towards  high-added-value  innovative  products,  thereby 
enhancing European competitiveness. 

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The  calls  have  been  met  with  a  good  response  from  both  the  research  and  industrial 
communities. Seven projects have been funded, with EUR 50 million. A further two pilot-line 
projects  have  been  funded  in  the  Production  Technologies  area  of  NMP,  with  EUR  19 
million, bringing the EU contribution to pilot lines to EUR 69 million (with a total investment 
of EUR 98 million). Collectively, these nine projects have over 150 participants, including 30 
large  industrial  partners  and  43  SMEs,  making  the  industrial  participation  close  to  50  %. 
Technology demonstration is a significant component of these projects, with nearly a quarter 
of  the  effort  dedicated  to  demonstration  activities.  To  allow  sufficient  time  for  technology 
demonstration, most projects will run for four years. Safety and life cycle assessment are also 
taken into account. 

As the objective of the pilot-line calls has been to support the progress of the most promising 
laboratory  results  towards  industrial  applications,  they  were  not  designed  to  be  sector-  or 
application-specific. As a result, they cover a wide range of applications and processes: 

–  Electrochromics for shading appliances; 

–  Atmospheric plasma deposition for nanoscale industrial surface processing; 

–  Atmospheric pressure plasma processing for 3D nanostructured surfaces; 

–  Nanopatterning based on nanoimprinting lithography; 

–  Antibacterial and antifungal medical textiles; 

–  Scale-up of the incorporation of nanoparticles in papermaking; 

–  Functional magnetic nanoparticle separation; 

–  Production of nanofluid coolants; and 

–  New generation of fluid lubricants incorporating nanomaterials. 

A  holistic  approach  is  common  for  the  projects  covering,  for  example,  (i)  development  of 
scalable  nanomaterial  production  technologies;  (ii)  development  of  large-scale  processing 
technologies  that  can  be  used  with  the  produced  nanomaterials;  and  (iii)  technology 
integration  and  pilot-scale  demonstration  of  real,  industrial  applications.  Ensuring  the  safe 
production of nanomaterials, as well as the safety of the final application or product, forms an 
integral part of the projects. 

The  pilot-line  projects  are  expected  to  result  in  significant  improvements  in  productivity, 
sustainability, product quality and its control; and to demonstrate the economic viability of the 
use of nanotechnology in their respective application areas. As the projects are at a very early 
stage of implementation, it is premature to anticipate the results. 

Apart from the dedicated pilot-line calls, several other projects target industrial applications: 
for  example,  CANAPE  on  the  production  of  carbon  nanotubes;  AMBIO  on  nanostructured 
surfaces to control bio-fouling; and INDOT on the production of nanophotonic devices. 

Turning to the general outlook for industrial applications, the second half of FP7 is expected 
to  see  a  gradual  shift  towards  more  application-oriented  research,  as  nanotechnologies 
developed  in  a  laboratory  environment  evolve  towards  applications  in  various  industrial 
sectors. A shift is also expected towards call topics that are more specific to particular sectors 
or  technologies,  as  part  of  the  effort  to  generate  critical  mass  and  more  strategic  impact  for 
selected  application  fields  of  high  priority.  The  potential  for  nanotechnology-enabled 
industrial applications in different sectors is outlined in section 4.3. 

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1.2.8.  Applications in energy and environment 

Nanotechnologies  have  a  significant  potential  for  breakthrough  advances  in  sustainable 
energy  conversion  processes,  addressing  in  this  way  current  environmental  and  climate 
change challenges. 

The 2009 Work Programme of NMP included a call “Nanotechnology for harvesting energy 
via  photovoltaic  technologies”,  with  the  objective  of  supporting  innovative  scientific  and 
technical research for improved efficiency, bringing devices with a more favourable cost per 
unit-area. The call was met with an excellent response: 70 proposals addressed a wide variety 
of  nanotechnology-based  materials  and  approaches  for  increasing  the  efficiency  of  solar 
harvesting. 

The vast majority of commercial solar cells today is based on crystalline silicon, because of 
the high module efficiencies that can be achieved. Yet the technology is rather expensive. A 
sizeable  number  of  the  proposals  therefore  focus  on  solving  this  issue  through  alternative 
approaches  using  silicon,  significantly  reducing  the  cost  without  compromising  the  cell 
efficiency.  Another  popular  topic  was  the  enhancement  of  the  performance  of  second-
generation  thin-film  cells,  while  maintaining  low  production  costs.  The  proposals  typically 
take into consideration the scaling-up of the laboratory results, as well as the construction of 
prototype  cells  with  the  help  of  industrial  partners,  for  a  realistic  proof  of  concept  and 
eventual industrial take-up. There is good reason to believe that the funded projects will pave 
the  way  for  highly  efficient  photovoltaic  cells  with  costs  well  below  the  “$1-per-Watt” 
benchmark. 

Complementary to the call on photovoltaics, the 2010 Work Programme of NMP includes a 
topic  on  thermoelectric  energy  converters  based  on  nanotechnology.  Such  converters  could 
find  applications  in  transport,  power  generation  and  refrigeration  requiring  a  high  power 
output.  For  example,  in  vehicles  using  internal  combustion  engines  and  power  generation 
plants, waste heat could be recovered, leading to cost savings and environmental benefits. 

Water treatment, whether for the production of drinking water or for the decontamination of 
polluted  water,  makes  ample  use  of  membrane  filtration  and  of  catalytic  oxidation  or 
reduction. The use of nano-engineered or nanostructured materials can significantly enhance 
the efficiency and selectivity of these processes (through process intensification and reduction 
of  by-product  generation),  and  reduce  their  energy  consumption  (through  lower  pressure 
drops). This leads to a much greater cost-effectiveness, and can also help with the production 
of portable water-treatment equipment. 

–  CLEANWATER  aims  to  develop  photocatalytic  active  membranes  capable  of  exploiting 
solar energy for improved detoxification of water streams (targeting cyanobacterial toxins, 
pesticides and endocrine disrupting compounds). 

–  MEMBAQ  aims  to  mimic  the  selective  transport  of  water  through  plant  leaves  by 
incorporating the plants’ selective channel structures, aquaporins, in polymer membranes. 

–  MONACAT  aims  to  produce  flow-through  catalyst  units  for  the  reduction  of  nitrates, 
bromates, and perchlorates, and for the oxidation of a range of organic pollutants including 
pesticides and endocrine disruptors. 

–  NAMETECH  aims  to  enhance  the  permeability  and  stability  of  membranes  for  water 
treatment, while reducing their vulnerability to fouling, by incorporating nanoparticles and 
nano-engineered materials. 

–  NEW  ED  aims  to  develop  nanoporous  bipolar  membranes  for  the  remediation  of  highly 

saline industrial waste water streams through electrodialysis. 

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–  WATERMIM  aims  to  produce  highly  selective  “molecularly  imprinted”  membranes,  by 
first  introducing  and  then  removing  target  substances,  so  that  these  membranes  are 
structured with nanosized pores that will preferentially absorb target substances. 

1.2.9.  Catalysts 

Catalysts  play  a  major  role  in  the  chemical  industry  and  other  related  industries,  being  the 
basis  for  more  than  20  %  of  the  world’s  industrial  production  processes.  Catalysts  are  key 
factors in minimising demands on energy and raw materials, as well as in reducing emissions 
from industrial  chemical production. Since many basic chemicals are  produced via catalytic 
routes  in  volumes  exceeding  one  million  tonnes  per  year,  even  minor  improvements  in 
catalyst performance translate into large savings in raw materials and energy consumption in 
large-scale processes. Given the fact that the European chemical industry is a major player in 
catalysis, activities in this field are a key to European competitiveness. 

The  high  surface-to-volume  ratios  (specific  surface  areas)  of  nanomaterials  makes  catalysis 
one  of  the  principal  ways  in  which  they  can  contribute  to  sustainable  manufacturing. 
Nanomaterials can be particularly effective as catalysts, leading to reductions in raw material 
and energy costs, improvements in selectivity and the minimisation of waste streams in many 
industrial  processes.  Using  nanomaterials  also  allows  reductions  in  the  required  amounts  of 
precious metals, such as platinum and palladium, which are extensively used as catalysts. 

Given the large range of applications that oxides have in catalysis and surface chemistry, it is 
not  surprising  that  nanostructured  oxides22  can  have  a  significant  impact  in  fields  like  the 
production  of  petrochemicals  (e.g.  reforming  of  light  hydrocarbons),  intermediates  and  fine 
chemicals,  with  the  benefits  described  above.  There  are  further  benefits  in  environmental 
protection,  for  example  in  the  abatement  of  NOx,  SO2  and  VOCs  (volatile  organic 
compounds). It is estimated that by 2020, nanostructured oxides will represent about one third 
of the total demand for metal oxides (including catalysis and other applications), from slightly 
more than 1 %  today.23 Last but not  least, nano-catalysts are expected to have an impact in 
biocatalysis,  such  as  the  use  of  biomass,  the  production  of  biofuels,  and  the  further 
development of an integrated and diversified biorefinery that can handle various feed stocks.24 

1.3. 

Research on health, safety and environmental issues (HSE) 

It  is  necessary  to  understand  any  risks  posed  to  human  health  and  the  environment  by 
nanomaterials,  and  more  generally  products  based  on  nanotechnology,  and  to  develop 
appropriate  testing  methods  and  exposure  measurements,  including  equipment.  This  section 
describes  only  the  research  aspects  of  risk  assessment,  while  chapter  6  presents  the  overall 
picture  with  regard  to  health,  environmental  and  consumer  protection,  including  the 
regulatory aspects. 

22 

23 

24 

New  compound  oxides  containing  non-transition  metals,  such  as  doping  TiO2  with  anions  such  as 
(carbon  and  nitrogen  are  not  anions),  SnNb2O6  or  BiVO4  for  direct  hydrogen  production  through 
photoctalysis;  Ni-catalyst  based  on  a  Mg-Al-Spinel  with  a  high  activity  and  resistance  to  sulphur  for 
catalytic reforming of light hydrocarbons; and so on. 
V. Cortés Corberàn & J. Carlos Conesa (2006), The Concorde NSOCRA White Paper – A Technology 
Roadmap on NanoStructured Oxide Catalysts for Redox Applications, SOCINTEC-Grupo AZERTIA – 
CONCORDE Consortium,  May,  ISBN  84-933135-4-8, Coordinated Action under  FP6 –  Contract Nr. 
NMP2-CT-2004-505834;  K.  Walsh  (2007),  Strong  Economy  and  New  Chemical  Capacity  Drive 
Demand, February 14/21, pp. 24, www.chemweek.com; R. Coons (2009), Catalysts: Seeking the Next 
Big Thing, Chemical Week, May 4, pp. 19-21, http://www.chemweek.com 
R.  Coons  (2009),  Catalysts:  Seeking  the  Next  Big  Thing,  Chemical  Week,  May  4,  pp.  19-21, 
www.chemweek.com;  ICIS  Chemical  Business  (2009),  Catalyst  creativity  –  Innovative  catalysts 
promise to improve the economics of chemical production, May 4-10, pp. 28-29, http://www.icis.com 

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Since  2005,  the  EU  Scientific  Committees  have  highlighted  in  their  opinions  the  paucity  of 
information in areas that are fundamental to the further development of guidelines on the risk 
assessment of nanomaterials. These are:  

(1) 

Information on nanomaterials on the market; 

(2)  Methods with comparable, reproducible and repeatable results;  

(3) 

(4) 

The choice of the most appropriate metrics for hazard and exposure assessment; 

Actual human and environmental exposure; 

(5)  Methods 

to  extrapolate  from 

to 
nanomaterials;  between  nanoparticles;  and  from  laboratory  tests  to  actual  hazards  to 
humans (including more sensitive groups) and the environment; 

toxicology  of  non-nanoscale  materials 

the 

(6) 

(7) 

Toxicokinetics  of  nanomaterials  from  various  portals  of  entry  to  target  organs, 
including possible new endpoints;25  

Environmental  fate,  distribution  and  persistence  (including  bioaccumulation  and 
biodegradability), and ecotoxicity of nanomaterials. 

Research projects and support actions designed to address the concerns with regard to health 
and  environmental  safety  (HSE)  have  been  launched  with  Framework  Programme  funding, 
and also by the European Commission’s Joint Research Centre (JRC). The funding for HSE 
research under the EC Framework Programmes has increased significantly over the years. In 
total, around EUR 75 million has been spent or committed in this area since 2005, of which 
EUR 50 million was committed in the first two years of FP7 (2007 and 2008) alone. Further 
research  on  safety  is  built  into  projects  developing  applications  in  order  to  integrate  safety 
aspects at the earliest possible stage, in accordance with the “integrated, safe and responsible” 
development of nanotechnologies and the Commission’s Code of Conduct.26 

A  compilation  of  HSE  research  projects  funded  by  the  EC  Framework  Programmes,  EU 
Member States, and Associated States27 was published in January 2008.28 In April 2008, the 
Commission  organised  a  workshop  on  “Research  Projects  on  the  Safety  of  Nanomaterials: 
Reviewing  the  knowledge  gaps”,  and  published  its  proceedings.29  In  order  to  set  common 
deliverables and carry out strategic planning, a “nanosafety cluster” was formed in February 
2009 for research projects addressing nanotechnology safety. It includes 24 FP7 projects, with 
five  more  projects  to  be  added  by  the  end  of  2009,  and  two  national  projects.  The  priority 
areas in this cluster are: 

–  Standard methods for measurement and characterisation of nanomaterials; 

–  Behaviour of nanomaterials in the body and in the environment; mechanisms of toxicity; 

–  Effects of nanomaterials on the human body and the environment; test methods including 

alternative test methods; 

–  Models and calculations to predict and assess toxicity, exposures and risks; 

25 

26 

27 
28 
29 

In  the  context  of  toxicity  and  ecotoxicity,  endpoints  are  properties  related  to  human  health  and 
environmental  safety.  They  should  provide  basic  characterisation,  fate,  ecotoxicity  and  mammalian 
toxicity information for nanomaterials. 
Commission  Recommendation  on  a  Code  of  Conduct 
nanotechnologies research, C(2008)424; section 5.1 below 
States associated to FP6 and FP7 
ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/final-version.pdf 
ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/final_report.pdf 

for  responsible  nanosciences  and 

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–  Database and information needs; 

–  Fate and behaviour of nanoparticles in the environment; and 

–  Risk assessment and life cycle assessment. 

Coordination  in  this  area  is  also  aided  by  a  new  High-Level  Group  on  nanotechnology,  of 
Member States and FP7 Associated States. One objective of the group is to maximise synergy 
between  EC  and  nationally  funded  research  work,  given  that  national  programmes 
increasingly extend their funding to HSE research. Furthermore, an ad hoc industrial advisory 
group  for  safety  has  also  been  proposed.  For  the  future,  the  intention  is  to  integrate  all 
stakeholders’  dialogues  in  a  European  Technology  Platform,  complemented  and  assisted  by 
national  platforms.  These  activities  are  also  coordinated  with  stakeholders  and  international 
partners  in  appropriate  forums,  such  as  the  OECD  Working  Party  for  Manufactured 
Nanomaterials (WPMN) and ISO.30 

These  activities  have  led  to  an  improved  understanding  of  the  interaction  mechanisms  of 
nanomaterials  with  biological  systems,  as  well  as  of  the  exposure  and  measurement  issues. 
Progress  in  key  areas  of  environmental,  health  and  safety  research  is  described  in  the 
following sub-sections, while section 6.4 describes aspects of risk management linked to the 
progress  of  this  research,  and  section  6.5  outlines  further  research  necessary  to  close  the 
knowledge gaps. 

1.3.1.  Characterisation, metrology and reference materials 

It  is  widely  acknowledged  that  a  proper  characterisation  of  nanomaterials  in  terms  of  a 
number  of  key  physicochemical  properties  is  essential  for  a  sound  comparison  of 
toxicological test results. Work within the OECD-WPMN and ISO/TC 229 has resulted in an 
initial consensus on a list of properties to be assessed prior to a toxicity test,31 comprising the 
following issues and properties: particle size and distribution; aggregation and agglomeration 
state;  composition;  shape;  solubility;  dispersibility;  surface  area;  surface  chemistry  (for 
example hydrophobicity); and surface charge. Testing methods exist for all these parameters, 
although not all are as yet validated for use with nanomaterials, nor standardised. 

It  is  clear  that  the  physicochemical  characterisation  of  nanomaterials  tested  for  toxicity  in 
various  biological  media  is  a  challenge  in  itself.  Even  between  laboratories  with  adequate 
equipment  and  specific  expertise  there  is  not  always  satisfactory  reproducibility,  because 
many  of the relevant properties strongly depend on the measurement  method  used to assess 
them.32 33 On the other hand, given the dynamic nature of some of the listed properties, their 
measurement cannot easily be outsourced and physically separated from the toxicology test. 
This  calls  for 
increased  collaboration  between  physicists,  chemists,  biologists  and 
toxicologists.  This  collaboration  will  necessarily  involve  stages  of  round-robin  testing  to 

30 

31 

32 

33 

More information on the work in the context of these two international organisations can be found in 
section 6.6 
Guidance  Manual  for  the  Testing  of  Manufactured  Nanomaterials  –  OECD-WPMN  Sponsorship 
Programme, ENV/JM/MONO(2009)20 
Interlaboratory  Study  to  Establish  Precision  Statements  for  ASTM  E2490-09  Standard  Guide  for 
Measurement  of  Particle  Size  Distribution  of  Nanomaterials  in  Suspension  by  Photon  Correlation 
Spectroscopy  (PCS),  Research  Report  E56-1001,  ASTM  Committee  E56  on  Nanotechnology, 
Subcommittee  E56.02  on  Characterisation:  Physical,  Chemical,  and  Toxicological  Properties,  April 
2009 
O.  Couteau,  G.  Roebben,  Comparison  of  dynamic  light  scattering  and  centrifugal  sedimentation  for 
nanoparticle  sizing,  Euronanoforum  2007,  Nanotechnology  in  Industrial  Applications,  June  19-21, 
2007, Düsseldorf, Germany 

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assess  the  proficiency  of  laboratories  and  reproducibility  of  methods,  following  the  rules  of 
metrology.34  35  A  recently  started  coordination  action  on  nanometrology,  Co-Nanomet,36 
includes a training programme on state-of-the-art characterisation methods for nanomaterials. 

An increasing number of reference materials are becoming available, and a database has been 
set up by the German Bundesanstalt für Materialforschung,37 as a support to the activities of 
ISO/TC 229  and  the  nanotechnology  community  at  large.  One  of  the  leading  producers  of 
reference  materials  is  the  Commission’s  JRC,  which  in  2008  released  the  IRMM-304 
colloidal silicon dioxide reference nanomaterial for use in the analysis of the size of spherical 
nanoparticles.  Other,  previously  released  reference  nanomaterials  continue  to  be  distributed 
by the JRC (nanoporous powders and nanoscale thin films on substrates).38 In the absence of 
formally  certified  reference  materials,  it  is  good  practice  in  collaborative  research  to  use  at 
least  a  common  source  of  test  samples  that  have  been  produced  according  to  a  well-
documented  procedure.  Such  common  test  materials  can  develop  into  reference  materials 
when  data  about  homogeneity  and  stability  become  available,  and  if  these  are  analysed  and 
reported  in  a  transparent  manner.  For  example,  the  Commission’s  JRC  has  organised  a 
repository of representative nanomaterials for testing purposes. It focuses on various forms of 
titanium  dioxide,  cerium  oxide,  zinc  oxide,  silver,  silicon  dioxide,  and  carbon  nanotubes, 
which are targeted by the OECD-WPMN sponsorship programme (see sub-section 6.6.1). 

1.3.2.  Research on potential human health hazards 

Progress  has  been  made  in  several  aspects  of  research  on  toxicity  testing  and  on  potential 
effects  of  nanomaterials  on  human  health.  This  area  has  been  addressed  by  numerous 
completed and ongoing EU-funded projects.  The findings  from some of these projects  were 
published in the proceedings of the workshop of April 2008, mentioned above.39 

In  addition  to  the  EU-funded  projects,  JRC  activities  in  this  area  focus  on  the  development 
and harmonisation of methods for the toxicity testing of nanomaterials; and the in vitro testing 
of a representative set of nanomaterials on critical cell lines. They encompass related studies 
on nanometrology and reference nanomaterials, as well as the development of databases and 
modelling  (applicability  of  in  silico  methods,  and  QSARs,  quantitative  structure-activity 
relationships). 

CANAPE:  This  integrated  project  addressed  the  production  of  carbon  nanotubes  on  an 
industrial  scale.  As  part  of  this  work,  it  considered  tests  for  different  endpoints  (such  as 
biocompatibility) and their validity in defining the toxicological effects of carbon nanotubes, 
fullerenes and nanostructured forms of carbon. 
NANODERM:40 This FP5 project evaluated the quality of skin as a barrier to particles of less 
than 20 nm in size. The main conclusions were: that titanium dioxide nanoparticles penetrate 
into the topmost 3-5 corneocyte layers by mechanical action; and that no diffusive transport 
takes  place.  Thus  penetration  studies  with  static  Franz-diffusion  cells  do  not  seem  adequate 
for  nanoparticles.  Clearance  is  expected  to  proceed  via  desquamation.  There  is  deep 

34 

35 
36 
37 
38 
39 
40 

ISO/IEC Guide 99-12:2007 International Vocabulary of Metrology - Basic and General Concepts and 
Associated Terms, VIM 
ISO/IEC Guide 43 Proficiency testing by interlaboratory comparisons, ISO, Geneva, 1997 
http://www.co-nanomet.eu 
http://www.nano-refmat.bam.de/en/ 
http://irmm.jrc.ec.europa.eu/catalogue 
ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/final_report.pdf 
http://www.uni-leipzig.de/~nanoderm/ 

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penetration into hair follicles, but not into vital tissue. Clearance is expected to proceed via 
sebum excretion. 
DIPNA41  addressed  the  impact  of  metallic  and  ceramic  nanoparticles  on  different  types  of 
cells, and designed assays and instruments for field analysis of nanotoxicology. 
NanoInteract42  developed  a  platform  and  toolkit  for  understanding  interactions  between 
nanoparticles and the living world. This included the issue of reproducibility. In 2007, a paper 
from this project, “Understanding the nanoparticle-protein corona using methods to quantify 
exchange rates and affinities of proteins for nanoparticles”, received one of six awards of the 
Proceedings  of  the  (US)  National  Academy  of  Sciences  (PNAS)  for  reflecting  “the  highest 
standards of scientific excellence and originality”. 
CellNanoTox43 developed a multi-disciplinary set of tests and indicators for the toxicological 
profiling of nanomaterials. 
PARTICLE  RISK44  studied  in  vitro  experiments  and  in  vivo  models  for  the  assessment  of 
adverse  health  effects  in  pulmonary,  hepatic  and  cardiovascular  target  systems.  The  project 
developed detailed procedures to investigate the association between short-term variations in 
air pollution and cardiovascular health, which can be used in future European studies. Data on 
levels  of  air  pollutants,  in  particular  size  and  number  distributions  of  particles  in  urban  air, 
were collected for three European cities. 
NANOTRANSPORT45 was a support action that studied the behaviour of aerosols released to 
ambient  air  from  nanomaterials  manufacturing,  and  the  efficiency  of  protective  equipment. 
The main conclusions were as follows: There is considerable evolution of nanoaerosols over 
time;  their  average  size  increases,  while  their  concentration  decreases.  Natural  background 
aerosols  are  scavengers  for  nanoparticles;  the  time  scale  for  size  evolution  depends  on  the 
concentration of nanoparticles and that of background aerosol. Nanoparticles will be present 
in size classes other than those in which they were originally emitted. Filtration efficiency for 
primary nanoparticles less than 80 nm is usually sufficiently high, but their agglomerates may 
be in the “most penetrating particle size” (MPPS) range of 80 nm to 200 nm. 
Impart-Nanotox46  was  a  combination  of  two  coordination  support  actions  that  worked  on 
improving  the  understanding  of  the  impact  of  nanoparticles  on  human  health  and  the 
environment. They made recommendations on regulation and research strategy, and produced 
a Guidance Booklet on Safe Handling of Nanoparticles. 
ENRHES47  (an  FP7  project  completed  in  2008)  was  a  support  action  to  perform  a 
comprehensive  and  critical  scientific  review  of  the  health  and  environmental  safety  of 
fullerenes,  carbon  nanotubes  (CNTs),  metal  and  metal  oxide  nanomaterials.  The  review 
considered sources, pathways of exposure and outcomes of health and environmental concern, 
informing regulatory activities. A final report is expected soon. 

41 
42 
43 
44 
45 
46 
47 
http://nmi.jrc.ec.europa.eu/project/ENRHES.htm 

http://www.dipna.net/ 
http://www.nanointeract.net/ 
http://www.fp6-cellnanotox.net/ 
http://www.iom-world.org/research/particle_risk.php 
http://research.dnv.com/nanotransport/ 
http://www.impart-nanotox.org/  
Engineered Nanoparticles: Review of Health and Environmental Safety, 

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Within  this  area  of  research,  the  following  FP7  projects  started  recently,  or  are  expected  to 
start soon:48 49 

INTRACELL:  Cell  analytics  at  nanoscale;  understanding  cellular  pathways  and  trafficking, 
differentiation process, substrate targeting, uptake, efficacy and toxicity; process modelling. 
NanoTEST:50  Alternative  testing  strategies  for  the  risk  assessment  of  nanomaterials  used  in 
medical  diagnostics.  This  includes  high-throughput  toxicity-testing  protocols,  using  in  vitro 
cell  lines  (blood,  vascular  system,  liver,  lung,  central  nervous  system,  digestive  system, 
inflammation, 
placenta  and  kidney)  for  mechanistic  studies  (on  oxidative  stress, 
immunotoxicology, genotoxicity and barrier transport); and validating these with short term in 
vivo studies and by developing in silico methods. 
ENPRA51 addresses a part of the hazard assessment of nanomaterials. In particular it aims to 
identify  the  critical  physicochemical  characteristics  of  nanomaterials,  which  are  responsible 
for  the  observed  toxicity,  by  investigating  their  interactions  at  the  cellular  and  molecular 
levels.  Such  mechanisms  are  underlying  the  observed  association  and  developing  systems. 
They  will  be  verified  by  performing  in  vivo  experiments  leading  to  the  development  of 
possible  high-throughput  alternative  toxicity  tests,  using  a  structure-activity  method  to 
facilitate the identification and prediction of possible hazards from nanomaterials. This work 
will also address the extrapolation of results from in vitro to in vivo data, and to other relevant 
occupational or consumer situations, by incorporating all possible data as weight-of-evidence. 
Nanommune  (with  four  US  partners):52  Analysis  of  immune  toxicological  effects  using  in 
vitro and in vivo model systems and state-of-the-art in silico (transcriptomics) and lipidomics 
protocols;  Comprehensive  assessment  of  hazardous  effects  of  engineered  nanomaterials  on 
the immune system. 
NeuroNano  (with  three  US,  one  Brazilian  and  one  Japanese  partner):53  Study  of  the 
interaction  of  nanomaterials  with  fibrillating  proteins  with  in  vitro  and  in  vivo  models.  Do 
nanoparticles  induce  neurodegenerative  diseases?  Understanding  the  origin  of  reactive 
oxidative species and protein aggregation in the presence of nanoparticles. 

NanoReTox  (with  one  US  partner):  The  reactivity  and  toxicity  of  engineered  nanoparticles: 
risks to the environment and human health. 

InLiveTox:  Intestinal,  Liver  and  Endothelial  Nanoparticle  Toxicity  –  Development  and 
evaluation of a novel tool for high-throughput data generation. 

HINAMOX: Health Impact of Engineered Metal and Metal Oxide Nanoparticles: Response, 
Bioimaging and Distribution at Cellular and Body Level. 

NANOPOLYTOX:  Toxicological 
weathering and recycling of polymer nanocomposites used in various industrial applications. 

impact  of  nanomaterials  derived  from  processing, 

48 

49 

50 
51 
52 
53 

At the time of writing, some of the projects listed in this section were expected to be funded but were 
still  in  the  negotiation  stage.  Therefore,  the  European  Commission  makes  no  commitments  as  to  the 
eventual funding of these projects. 
At the time of writing, not all projects had dedicated websites. Basic information may be found on the 
CORDIS website, http://cordis.europa.eu/fp7/projects_en.html. 
http://www.nanotest-fp7.eu/ 
Risk Assessment of Engineered Nanoparticles, http://www.enpra.eu/ 
http://ki.projectcoordinator.net/~NANOMMUNE 
http://www.neuronano.eu/ 

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Finally,  the  NANOGENOTOX  Joint  Action,  bringing  together  eighteen  Member  States,  is 
funded  under  the  Commission’s  Second  Health  Programme.54  It  focuses  on  the  “safety 
evaluation  of  manufactured  nanomaterials  by  characterisation  of  their  potential  genotoxic 
hazard.”  The  nanomaterials  considered  will  include  titanium  dioxide,  silicon  dioxide  and 
carbon  nanotubes.  NANOGENOTOX  focuses  not  only  on  the  generation  and  exchange  of 
data, but also on the further development of reliable testing methods. It supports the European 
contribution to the work taking place under the auspices of the OECD-WPNM. 

1.3.2.1.  Alternatives to Animal Testing 

Alternatives  to  animal  testing  are  relevant  to  the  assessment  of  both  human  toxicity  and 
ecotoxicity. 

In  November  2005  the  Commission  created  the  European  Partnership  on  Alternative 
Approaches  to  Animal  Testing  (EPAA).  This  has  promoted  cooperation  with  industry  and 
other stakeholders. The partners are committed to pooling knowledge, research and resources 
to accelerate the development, validation and acceptance of alternative approaches. The aim is 
to  develop  tools  in  genomics,  computational  technologies  and  high-throughput  testing 
systems,  to  assess  the  safety  of  chemicals,  including  pharmaceuticals,  vaccines,  food 
additives, pesticides and cosmetic products, and to achieve an unprecedented decrease in the 
use of experimental animals. 

Extensive  research  is  underway  on  alternative  ways  of  assessing  safety,  and  on  the 
possibilities  of  refining,  reducing  and  ultimately  replacing  animal  testing.  The  most  recent 
commitment was by the Commission, through the FP7 Health programme,55 and the European 
cosmetics industry (Colipa) for research into alternative testing methods. A total Community 
and  private  funding  of  up  to  EUR  50  million  will  be  allocated  in  2010  to  research  projects 
laying the scientific foundation for safety testing methods that will be faster and cheaper than 
animal tests, and have a higher predictive value. The results of the projects may benefit not 
only  the  cosmetics  industry,  but  also  the  pharmaceutical  and  chemical  industries  and  other 
relevant sectors. 

Before  a  test  method  can  be  used  in  the  context  of  a  product  authorisation,  regulatory 
authorities  must  accept  it.  The  EPAA  partners  are  looking  into  different  possibilities  to 
accelerate  that  process,  through  improved  information,  reapplication  of  solutions  across 
sectors, and international regulatory dialogue. 

The Commission’s JRC also hosts the European Centre for Validation of Alternative Methods 
(ECVAM),56  which  performs  research  on  the  development  of  alternative  testing  methods 
directly targeting animal tests to be replaced. Following scientific validation by ECVAM, the 
test methods have to be validated in the OECD before their acceptance for global use and a 
mutual acceptance of data. 

In order to promote the development of alternative methods for the regulatory acceptance of 
nanomaterials  and  their  applications,  the  EU  is  funding  three  projects,  NanoTEST,  ENPRA 
and  NANOGENOTOX,  together  with  some  Member  States.  NanoTEST  and  ENPRA  will 
develop alternative testing strategies and high-throughput toxicity-testing protocols, as well as 
developing  in  silico  methods  essential  for  the  risk  assessment  of  nanomaterials.  This  would 
allow predictions of the hazards of new materials, extrapolating the results from in vitro to in 

The Second Programme of Community Action in the Field of Health 2008-2013, 

54 
http://ec.europa.eu/health/ph_programme/pgm2008_2013_en.htm 
55 
Call FP7-HEALTH-2010-Alternative-Testing 
56 
http://ecvam.jrc.it/ 

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vivo,  and  to  other  relevant  occupational  or  consumer  situations.  NANOGENOTOX  will 
develop validated in vitro alternatives to animal testing for the genotoxicity of nanomaterials. 
All  three  projects  will  contribute  to  the  harmonisation  and  formal  validation  process  in  the 
ECVAM and later on in the OECD. 

The OECD-WPMN has a steering group (SG7), chaired by Germany and the Commission, on 
the  role  of  alternative  methods  for  assessing  the  safety  of  nanomaterials,  which  aims  at 
integrating  alternative  test  methods  and  testing  strategies,  and  supports  the  validation  of 
methodologies  where  applicable.  Alternative  testing  methods  are  an  integral  part  of  the 
sponsorship programme of WPMN.57 A report on the subject is expected to be published by 
the OECD. 

1.3.3.  Research on potential exposure throughout the life cycle 

Research  on  exposure  has  so  far  focused  on  workplace  exposure,  as  this  is  potentially  the 
most important exposure route. Two FP6 projects completed in 2009 addressed exposure and 
measurements:  NANOSH58  and  Nanosafe2.59  Nanosafe2  provided  information  on  the 
effectiveness  of a  range of risk  management  measures for occupational exposure. Examples 
are process enclosure, ventilation and filtering, and personal protective equipment (PPE). The 
results have been fed into the compilations of guidance documents published by the OECD-
WPMN.60 NANOSH led to interesting developments in measurement and sampling strategies. 
The following table summarises the progress made in these projects. 

Item 

Project 

Description 

State of progress 

Identification of sources of 
engineered/ manufactured 
Nanomaterials and other 

Characterisation of particles from 
sampling, labelling  

On-line detection and 
measurement methods including 
assessment of various 
methodologies 

Personal exposure 

NANOSH 
Nanosafe2 

Combination of measurements to 
distinguish manufactured 
nanomaterials from other 
nanoparticles 
NANOSH  Use of precipitators for direct 
deposition of nanomaterials on 
TEM grid and others (e.g. particle 
size analysers; scanning 
microscope) 

Nanosafe2  Development of new devices for 
sampling (and on-line detection) 
including assessment of various 
methodologies 

NANOSH 
Nanosafe2 

Direct deposition of nanomaterials 
on TEM grid in breathing zone and 
other methods 

Qualitative assessment of dermal 
exposure 

NANOSH 

Decrease of particle release 
during production of 
nanomaterials 
Air purification, respirators, 
personal protective equipment 
Release of nanomaterials from 
textiles 
Calibration 

Introduction of a slightly modified 
version of a structured 
questionnaire (DREAM) 

Nanosafe2  Development of reactor for 

synthesis of powders 

Filter efficacy testing 

NANOSH 
Nanosafe2 
Nanosafe2  Test method and equipment for 

nanomaterials release  

Nanosafe2  Methods and equipment for 

measuring instruments calibration 

Principles demonstration, pilot 
measurements in labs and industry 
production sites showing feasibility of 
their applications 
Pilot studies showed feasibility of its 
application 

Demonstration of principles, 
development of low cost alarm devices, 
of devices for large size range NPs, of 
analysers showing feasibility  

Measurements done in production 
facilities of nanomaterials and other 
powders (eg micro zinc oxide) showing 
feasibility 
Pilot studies showed feasibility of its 
application and evidence of dermal 
exposure potential 
Demonstration of principles showing 
feasibility, work continues in the project 
SAPHIR 
Completed and pilot study performed 

Standard method proposed and proposed 
for formal standardisation work 
Completed equipment demonstrated at 
laboratory scale  

57 
58 
59 
60 

http://www.olis.oecd.org/olis/2009doc.nsf/LinkTo/NT0000498A/$FILE/JT03267857.PDF, p. 20 
http://www.ttl.fi/Internet/partner/Nanosh/ 
http://www.nanosafe.org/ 
http://www.oecd.org/dataoecd/36/36/42594202.pdf 

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Nanosafe2 worked on devices for measuring workplace exposure, incorporating background 
subtraction.  Furthermore,  the  EU-funded  NanoCap  project  generated  a  strategy  for 
occupational  hygiene  adapted  to  nanomaterials,  involving  elements  such  as  the  containment 
process and personal protective equipment. 

Within this area of research, the following FP7 projects started recently: 
NanoDevice,61 a large collaborative project, will develop reliable methods and equipment for 
the  measurement  of  nanoparticles,  in  particular  novel,  portable  and  easy-to-use  devices 
suitable for workplaces.  

ENNSATOX: Engineered Nanoparticle Impact on Aquatic Environments: Structure, Activity 
and Toxicology, will in particular examine the long-term environmental and health impacts of 
a number of commonly used nanoparticles such as zinc oxide and titanium dioxide, used in 
products  such  as  paints  and  cosmetics.  It  will  also  look  at  the  relationship  between  the 
physical structure of the nanoparticles and their toxicity. 

NANEX: Development of Exposure Scenarios for Manufactured Nanomaterials, is a support 
action  that  will  collect  and  review  exposure  data,  exposure  metrics,  risk  management 
measures  and  existing  models.  Its  goal  is  to  develop  and  standardise  a  catalogue  of  generic 
and specific exposure scenarios for nanomaterials, taking their entire life cycle into account, 
and  covering  occupational,  consumer  and  environmental  exposure.  This  should  help  close 
knowledge gaps in exposure assessment, including risk management. 

1.3.4.  Research on potential ecotoxicity, environmental fate and behaviour 

The NanoInteract project (sub-section 1.3.2) studied the fate and effects of aggregated CeO2 
nanoparticles in water and concluded that no acute toxicity was observed for any of the three 
different environmental species tested. For chronic aquatic toxicity, it concluded that toxicity 
is  related  to  the  surface  area  and  not  exclusively  to  mass,  despite  the  nanomaterial 
aggregation.  A  decrease  of  feed  concentration  was  also  observed  in  the  vicinity  of  the 
nanomaterial  delivery.  A  crucial  step  in  making  standard  ecotoxicity  test  methods  more 
reliable  for  nanomaterials  is  the  collection  of  knowledge  on  direct  and  indirect  effects  of 
nanomaterials. Hypothesis testing and the assessment of non-standard endpoints may play an 
important role in this process. Finally, it was concluded that it is advisable to analyse different 
endpoints and consider the appearance of measurement artefacts and indirect effects. 

In  order  to  improve  the  research  in  this  field  by  coordinating,  and  joining  forces  with, 
activities in Member States, the SKEP62 ERA-NET (Scientific Knowledge for Environmental 
Protection) was initiated. This is a partnership of 17 national funding agencies in 13 different 
countries,  responsible  for  funding  environmental  research.  The  SKEP  network  aims  to 
facilitate science-led policy making, and to support evidence-led regulation. 

Within  this  area  of  research,  the  following  FP7  projects  started  recently,  or  are  expected  to 
start soon: 

NEPHH:  Nanomaterials  related  Environmental  Pollution  and  Health  Hazards  throughout 
their  Life  Cycle.  The  purpose  of  this  project  is  to  identify  and  rate  important  forms  of 
nanotechnology-related  environmental  pollution  and  health  hazards  that  could  result  from 
activities  involved  in  nanostructures  throughout  their  life-cycle,  and  to  suggest  means  that 
might reduce or eliminate these impacts. 

61 
62 

see, e.g., ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/nanodevice_kai_savolainen.pdf 
http://www.skep-era.net/site/2.asp 

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NanoFATE: Nanoparticle Fate Assessment and Toxicity in the Environment. The work seeks 
to  assess  the  environmental  fate  and  potential  risks  of  specific  nanomaterials  used  in  high-
volume  products,  for  which  recycling  is  not  an  option:  fuel  additives,  personal  care  and 
antibacterial  products.  Two  commercially  relevant  nanomaterials  derived  from  each  one  of 
three  substances  (CeO2,  ZnO  and  Ag),  of  varying  size,  surface  and  core  chemistry,  will  be 
monitored  throughout  their  post-production  life  cycles,  i.e.  from  environmental  entry  as 
“spent product”, through waste treatment, to their final fates and possible toxic effects. 

1.3.5.  Research on life cycle assessment (LCA) of nanomaterials 
Progress  has  been  made  in  the  European  Platform  on  Life  Cycle  Assessment,63  which 
developed an International Reference Life Cycle Data System (ILCD) Handbook of technical 
guidance  documents  for  LCA,  to  be  published  in  2009.  It  is  a  project  of  the  Commission’s 
JRC. 

In  order  to  allow  nanomaterial  LCA  based  on  this guidance, it is still necessary  to generate 
relevant data (including toxicology, fate, transport and scaling data). Major efforts are needed 
to  assess  fully  potential  risks  and  environmental  impacts  of  nanotechnology-based  products 
and  nanomaterials  (not  just  those  related  to  LCA).  The  EU-funded  PROSUITE  project  is 
further  developing  LCA  into  a  full  analysis  of  sustainability;  this  will  include  some 
nanomaterials  such  as  those  in  the  OECD-WPMN  sponsorship  programme  (see  sub-section 
6.6.1). 

Within this area of research, the following FP7 projects are expected to start soon, aiming to 
create  a  holistic  and  prospective  view  on  the  environmental,  health  and  safety  aspects  of 
different nanomaterials: 

NanoHouse: Life Cycle of Nanoparticle-based Products used in House Coating. 

NanoSustain: Development of sustainable solutions for nanotechnology-based products based 
on hazard characterisation and LCA. 

1.3.6. 

Sources  of  information  on  research  on  health,  safety  and  environmental  issues  of 
nanomaterials 

A  plethora  of  research  results  is  appearing  in  a  number  of  databases,  mainly  in  the  form  of 
bibliographic  references.  It  is  still  necessary  to  extract  data  from  the  published  papers  to 
underpin the risk assessment of specific substances in specific applications. European-based 
and other publicly accessible databases are as follows: 
–  The  EU-funded  NHECD64  project  was  launched  in  December  2008,  with  the  aim  of 
creating  a  “critical  and  commented  database  on  the  health,  safety  and  environmental 
impact  of  nanoparticles”  based  on  data-mining  techniques;  an  overview  of  all  available 
databases is given on the website of this project. 

–  EUPHIX,65 a web-based knowledge system that presents structured European public health 
information  with  a  special  insight  into  similarities  and  differences  in  various  Member 
States. 

–  SAFENANO,66 a searchable database on reports, journal and magazine articles on health 
and safety aspects of nanomaterials operated by the Institute of Occupational Health (UK). 

63 
64 
65 
66 

http://lct.jrc.ec.europa.eu/eplca 
http://www.nhecd-fp7.eu/ 
http://www.euphix.org/object_document/o4581n27010.html 
http://www.safenano.org/AdvancedSearch.aspx 

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–  The  Nano  Archive,67  a  part  of  the  FP7  project  ICPCNanoNet,68  provides  free  access  to 
published nanoscience research in the EU and International Cooperation Partner Countries, 
related to environmental, health and safety aspects of nanotechnologies,  

–  The  Commission’s  JRC  developed  and  launched  the  NAPIRA  hub,  an  information 
management  system  on  nanotechnology  safety,  containing  information  specific  to 
nanomaterials, as well as information on the methodology used. The intention is to develop 
this further and adapt it to nanomaterial datasets. 

–  The OECD-WPMN developed a database69 of finalised and ongoing research projects on 
the  risk  assessment  of  nanomaterials  (earlier  this  database  was  supported  by  the  US 
Woodrow Wilson Centre). 

–  Finally,  the  EU-funded  NanoImpactNet70  is  a  coordination  action  for  projects  on  HSE 
research,  which  will  also  communicate  results  to  stakeholders  and  their  needs  back  to 
researchers;  and  make  contributions  to  infrastructure  and  training  (as  mentioned  in 
chapters 2 and 3 below). 

1.4. 

European Technology Platforms 

Several  European  Technology  Platforms  (ETPs)  are  either  dedicated  to  nanotechnology 
applications  or  address  applications  in  which  nanotechnology  is  highly  relevant.  Research 
priorities identified by these ETPs are being taken on board in FP7 calls for proposals. This 
section outlines the work of the most relevant ETPs. More ETPs than those outlined below are 
relevant  to  nanotechnologies,  in  the  sense  that  the  applications  pursued  in  each  case  can  be 
enabled  or  enhanced  by  solutions  based  on  nanotechnology.  Examples  are  EuMaT71 
(Advanced Engineering Materials and Technologies); Hydrogen and Fuel Cell Technology72 
(in collaboration with the Commission’s JRC); ARTEMIS73 (embedded computing systems); 
EPoSS74 (smart systems integration); and FTC75 (future textiles and clothing). 

1.4.1.  European Nanoelectronics Initiative (ENIAC) 

ENIAC  (European  Nanoelectronics  Initiative  Advisory  Council)  is  the  ETP  dealing  with 
nanoelectronics76  (see  also  section  1.2.1).  ENIAC  develops  the  Strategic  Research  Agenda 
(SRA)  for  most  European  research  in  the  field.77  It  is  playing  a  key  role  in  defining  the 
research topics in nanoelectronics for FP7, as well as for the ENIAC Joint Undertaking (JU). 
The  latter  is  active  since  the  beginning  of  2007,  as  the  legal  instrument  implementing  the 
more  industrially  oriented  part  of  the  research  agenda,  along  with  the  CATRENE  cluster, 
while the more upstream research is funded under FP7. The ENIAC ETP is still active as an 
independent  body  of  the  Joint  Undertaking,  with  the  general  goal  of  mobilising  European 
efforts in this innovation- and technology-intensive sector. 

67 
68 
69 
70 
71 
72 
73 
74 
75 
76 
77 

http://www.nanoarchive.org/view/subjects/HA.html 
http://www.icpc-nanonet.org/content/view/26/39/ 
http://www.oecd.org/about/0,3347,en_2649_37015404_1_1_1_1_37465,00.html 
http://www.nanoimpactnet.eu/ 
http://www.eumat.org/ 
http://ec.europa.eu/research/fch/index_en.cfm; this ETP led to the Fuel Cell and Hydrogen JTI  
http://www.artemis.eu/ 
http://www.smart-systems-integration.org/ 
http://textile-platform.eu/ 
http://www.eniac.eu/ 
http://www.eniac.eu/web/downloads/SRA2007.pdf 

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The  Eureka78  cluster  CATRENE79  for  “Application  and  Technology  Research  in  Europe  on 
Nanoelectronics” is a four-year programme that started in January 2008 and is extendable to 
eight years. It builds on the success of the previous EUREKA programmes JESSI, MEDEA 
and MEDEA+ to foster the continued development of a dynamic and competitive European 
industry  in  nanoelectronics.  The  total  effort  will  be  around  4,000  person-years  per  annum, 
equalling about EUR 6 billion for the extended programme. 

1.4.2.  Photonics21 ETP 
Photonics2180  unites  the  majority  of  the  leading  photonics  industries  and  relevant  R&D 
stakeholders throughout Europe. At present, there are over 1,400 members from 49 countries. 
The aim of Photonics21 is to establish Europe as a leader in the development and deployment 
of photonics in key industrial areas, including ICT, lighting and displays, manufacturing, life 
science  and  security.  The  Strategic  Research  Agenda  for  photonics  was  first  published  in 
April 2006.81 The second SRA will be published in January 2010. Moreover, the market study 
“Photonics  in  Europe:  Economic  Impact”  was  published  in  December  2007.  This  study 
assessed  the  size  of  the  European  and  global  market  in  photonics,  identifying  those  sectors 
where  Europe  leads  the  world.82  The  Photonics21  Mirror  Group,  which  was  set  up  in  July 
2007,  brings  together  representatives  from  the  various  funding  bodies  of  Member  States,  to 
discuss a coordinated strategy for photonics research. This has resulted in an ERA-NET Plus 
being set up which will jointly fund photonics research. 

1.4.3.  Nanomedicine ETP 
The Nanomedicine83 ETP is an industry-led consortium, bringing together the key European 
stakeholders in the field, including SMEs, hospitals, research organisations and universities. It 
also  includes  representatives  of  funding  agencies  from  Member  States  and  Regions.  The 
Nanomedicine  ETP  currently  has  around  130  member  organisations,  about  40  of  which  are 
industrial.  It  stimulates  the  collaboration  of  the  stakeholders  and  provides  input  on  research 
priorities to the public authorities. The Nanomedicine ETP was founded in September 2005, 
when it published its long-term strategic vision paper for the sector. It has grown significantly 
in  membership,  visibility  and 
impact.  The  Strategic  Research  Agenda  (SRA)  for 
Nanomedicine  was  published  in  November  2006,84  with  the  main  aim  of  putting  forward  a 
sound  basis  for  decision-making  processes  for  policy  makers  and  funding  agencies,  by 
providing an overview of the needs, challenges, existing technologies and future opportunities 
in  nanomedicine.  The  SRA  also  takes  into  consideration  education  and  training,  ethical 
requirements,  risk-benefit  assessment,  public  acceptance,  the  regulatory  framework  and 
intellectual property issues. R&D  priorities defined in the SRA are  consistently being taken 
on board. These are outlined in the sub-section on nanomedicine above. Three years after the 
publication  of  the  SRA  for  nanomedicine,  the  updated,  industry-driven  “Roadmaps  in 
Nanomedicine towards 2020” will be published by the end of 2009, the aim being to identify 
trends in research and their expected impact on applications, products and markets. 

78 
79 
80 
81 
82 
83 
84 

http://www.eureka.be/ 
http://www.medeaplus.org/web/about/presentation.php 
http://www.photonics21.org/ 
http://www.photonics21.org/download/sra_april.pdf 
http://www.photonics21.org/download/Brosch_Photonics_Europe.pdf 
http://www.etp-nanomedince.eu/ 
http://www.etp-nanomedicine.eu/public/public/press-documents/publications/strategic-research-agenda 

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Sustainable Chemistry (SusChem) 

1.4.4. 
The  European  Technology  Platform  for  Sustainable  Chemistry  (SusChem)85  seeks  to  boost 
research, development and innovation in chemistry, biotechnology and chemical engineering. 
Chemistry  is  ubiquitous  and  vital  for  the  quality  of  modern  life.  More  and  better  use  of 
chemistry  will  enable  European  society  to  become  more  sustainable.  This  requires  major 
innovations in chemistry, as well as a successful and healthy European chemical industry. Not 
only  is  innovation  in  chemistry  a  key  to  the  sustainable  growth  of  the  European  chemical 
industry, but it also acts as a catalyst for sustainable innovation in upstream and downstream 
including  consumer  product  sectors.  Furthermore,  sustainable  chemical 
industries, 
technologies can improve public confidence in the chemical industry. 

The  technologies  relevant  to  SusChem  include  applications  in  energy  (batteries  and 
photovoltaics);  health  (nanostructured  sensors,  targeted  delivery  and  HSE);  transport  (new 
materials,  catalysts  and  fuel  cells);  information  and  communication  technologies  (new 
processing  technologies,  integration  of  nanostructures,  memories  and  interconnects);  and 
materials.  In  SusChem’s  Implementation  Action  Plan86  (IAP)  published  in  December  2006, 
nanotechnologies  are  seen  as  important  enabling  technologies  for  the  development  of  new 
materials for these applications. 

SusChem  members  became  involved  in  more  than  eighty  European  research  projects 
addressing transport, energy, health, information and communication technologies, as well as 
various  nanotechnologies  directly.  SusChem  has  carried  out  an  impact  assessment,  which 
found that the following topics in its IAP have yet to be sufficiently addressed: (i) embedded 
sensors (e.g. for the safety of wind generators); (ii) energy saving, including efficient lighting; 
(iii)  sealing  technologies;  (iv)  increasing  the  lifetime  and  efficiency  of  batteries,  and  high-
power  batteries  for  transport  applications;  (v)  integration  of  high-energy  batteries  for 
applications  in  renewable  and  distributed  energy  networks;  and  (vi)  supercapacitors  using 
ionic liquid electrolytes for long-life, high-voltage and high-temperature applications. 

Taking also into account the current topics of interest in the field of materials technology, it 
was  decided  to  focus  on  energy  over  the  next  few  years,  as  part  of  an  “Energy  Efficiency 
Cluster”. Several other areas are nevertheless also being tackled: 

–  Energy applications, in particular batteries, (organic) photovoltaics and supercapacitors; 

–  Health, including nanostructured sensors for biomedical devices and controlled release of 

bioactive ingredients; 

–  Transport,  including  better  catalysts  for  fuel  cells,  high  performance  lightweight 

composites, and nanomaterials for emission abatement; 

–  Information and communication technologies, including integration of nanostructures into 
devices; new processing techniques; memories, for instance by the application of nanoscale 
ferroelectric  oxides;  interconnects,  such  as  lead-free  soldering  for  power  electronics  and 
LEDs; and 

–  Nanomaterials, including research on new functional materials such as piezoelectric films 
in  microsystems;  stabilisation  of  primary  particles  on  surfaces;  nanomaterials  for 
thermoelectrics;  corrosion  prevention,  for  instance  alternative  materials  for  tinplate 
passivation; 

85 
86 

http://www.suschem.org 
http://www.suschem.org/content.php?_document[ID]=2049&pageId=3217 

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–  Finally, self-assembled and smart surfaces are seen as areas of future strategic importance. 

The  Smart  Energy  Home  Visionary  Project  of  SusChem  integrates  the  possible  benefits  of 
using  nanomaterials  for  construction  and  retrofitting,  as  smart  materials  and  surfaces,  self-
cleaning surfaces, sound insulation and for active noise abatement.87 

The latest SusChem stakeholder event in Prague in February 2009 provided a good overview 
of the various relevant projects that have been selected for funding under FP7. The event also 
addressed the benefits and safety of nanomaterials.88 

1.4.5.  Micro- and Nano-Manufacturing (MINAM) 
The  MINAM  association,89  part  of  the  Manufuture  ETP,  has  continued  to  grow,  with  a 
membership reaching 700 and increasing participation in various policy and implementation 
activities. The active involvement of European industry, including SMEs, in research has been 
a  key  objective  of  the  MINAM  association,  in  addition  to  its  general  goal  of  establishing  a 
new 
the  manufacturing  of  products  based  on  emerging  micro-  and 
nanotechnologies. 

industry  for 

MINAM has contributed to the FP7 call planning, in micro- and nano-technology, materials 
and production, and is actively supporting the development of nanotechnology research with a 
clear industrial potential. Recommendations from MINAM have recently been supplemented 
by  its  roadmapping  activities.  MINAM  is  presently  involved  in  work  to  establish  a  multi-
sectoral, integrating platform, “NANOfutures”, with the objectives of linking and representing 
all ETPs that require nanotechnologies. “NANOfutures” should serve as a hub for all relevant 
sectors: 

–  Identifying  common  elements  and  creating  synergies  between  the  ETPs  and,  where 
appropriate,  with  national  and  regional  programmes,  ERA-NETs  and  Networks  of 
Excellence. 

–  Developing a joint programme of activities with the objective of meeting major challenges; 
e.g.  clean  and  sustainable  manufacturing,  competitive  and  socially  responsible 
commercialisation  of  nanotechnology,  materials,  and  “horizontal”  technologies  that  will 
enable competitive and sustainable developments in a range of industrial sectors. 

MINAM furthermore contributes to several other activities including the Manufuture ETP and 
the  private-public  partnership  on  “Factory  of  the  Future”.  It  is  worth  mentioning  in  this 
context the MNT ERA-NET in micro-nano manufacturing.90 

1.4.6.  European Technology Platform on Industrial Safety (ETPIS) 
ETPIS91  has  coordinated  much  work  on  the  safety  of  nanomaterials  and  related  processes, 
with a dedicated focus group.92 The Nanosafety2 project described in sub-section 1.3.3 above 
is integrated in ETPIS.93 

The  iNTeg-Risk  project,  linked  to  the  Focus  Group  on  Emerging  Risk  of  ETPIS,  aims  to 
coordinate  R&D  for  improving  the  management  of  risks  related  to  new  materials  and 

87 
88 
89 
90 
91 
92 
93 

http://www.smartenergyhome.eu/downloads/seh_leaflet.pdf 
http://www.suschem.org/content.php?pageId=3602&lang 
http://www.minamwebportal.eu/ 
http://www.mnt-era.net/MNT/ 
http://www.industrialsafety-tp.org/news.aspx?lan=230&tab=148&nid=88#n88 
See for example http://euvri.risk-technologies.com/events/event_3/default.htm 
See for example 
http://www.nanosafe.org/scripts/home/publigen/content/templates/show.asp?P=69&L=EN&SYNC=Y 

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technologies.  This  should  reduce  the  time  to  market  for  lead  technologies,  as  well  as 
promoting  safety,  environmental  friendliness  and  social  responsibility  as  a  trademark  of 
advanced EU technologies. 

To achieve its goal, iNTeg-Risk relies on five R&D sub-projects of five-year duration. More 
than  200  tasks  focusing  on  critical  factors  have  been  included.  The  project  will  essentially: 
identify  specific  emerging  risks  from  particular  study  cases;  develop  solutions  for  the 
identified  risks;  validate  the  solutions,  disseminate  them  through  the  iNTeg-Risk  “one-stop 
shop”  and  finally  ensure  continuity.94  This  project  started  in  December  2008;  its  initial 
activities were presented at a conference in June 2009. 

1.5. 

EuroNanoForum 2009 

EuroNanoForum 2009 was a four-day conference in Prague on 2-5 June 2009, organised with 
EU support as an event of the Czech Presidency, under the auspices of the Czech Ministry for 
Education, Youth and Sports. Previous events in the EuroNanoForum series were organised in 
2003,  2005  and  2007  (by  the  Presidencies  of  Italy,  the  United  Kingdom  and  Germany, 
respectively).  The  theme  of  the  2009  conference,  which  was  attended  by  more  than  700 
participants  from  36  countries,  was  the  sustainable  development  of  European  industry  and 
society. It also showcased industrial technologies enabled by nanotechnologies. 

The conference highlighted a broad spectrum of nanotechnologies, which could significantly 
contribute to industries including chemicals, automotive, shipping, aeronautics, construction, 
textiles,  food,  biotechnology,  healthcare,  manufacturing,  power  generation  and  storage, 
electronic  and  electrical  engineering,  and  environmental  remediation.  The  technology 
readiness, end-user needs, benefits and risks have been assessed within each of 33 conference 
sessions.  The  summaries  of  these  sessions  will  be  used  to  guide  future  political  actions  in 
research on nanosciences, nanotechnologies and converging sciences. 

Following  the  presentations  in  plenary  sessions  and  associated  panel  discussions,  the 
participants arrived at the following conclusions: 

1.5.1.  Environmentally sustainable and energy-efficient industrial production 

The interest in nanomaterials and metal nanoparticles as catalysts is increasing, as a means of 
achieving reductions in energy consumption and waste streams, as well as improvements in 
selectivity.  Examples  include  the  use  of  superparamagnetic  nanoparticles  as  heterogeneous 
catalysts. Other promising concepts to improve energy efficiency are micro reactors and novel 
reactive media, such as ionic liquids. 

Nanotechnology  can  contribute  to  significant  decreases  in  energy  demand  during  the 
construction of new buildings, and in greenhouse emissions from existing ones. 

In the transport sector, nanotechnology will have an impact on production and operating costs, 
and lower the environmental impact for new-generation cars, as well as ships and aircraft. 

1.5.2.  Energy and environment 

Rapidly  expanding  fields  of  nanotechnology  could  contribute  to  a  clean,  energy-efficient 
society and to a plentiful supply of low-cost sustainable and renewable energy, in the form of 
photovoltaics, wind generation and thermoelectric conversion systems. Any new technologies 
should  be  suitable  for  large-scale  application,  and  capable  of  providing  reliable,  stable 
solutions.  Amongst  the  highlighted  research  results  fulfilling  these  criteria  are  solar  cells 
based on dye-sensitised nanocrystalline titanium dioxide. 

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http://www.integrisk.eu-vri.eu/home.aspx?lan=230&tab=51&itm=192&pag=196 

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The environmental benefits may in some cases be compromised by unintended consequences 
of using nanoscale materials, but further data are needed to assess and mitigate possible risks. 
The climate-forcing effects of natural and engineered nanoparticles in the atmosphere should 
also be investigated. 

1.5.3.  Nanotechnology for sustainable healthcare 

Despite  the  coordination  effort  and  increased  funding  for  nanomedicine,  industrial  concerns 
about the maturity of these technologies still exist. Nevertheless, nanotechnology is helping to 
bring  about  important  advances  in  diagnostics,  drug  delivery  and  regenerative  medicine. 
Presentations  showed  how  in  vitro  diagnostics  are  increasingly  linked  to  new  drug 
propositions;  in  vivo  imaging  is  combining  different  reagents  and  biomarkers;  and 
biodegradable  nanofibre  scaffolds  are  helping  to  treat  previously  incurable  conditions.  The 
conference called for a better cooperation amongst researchers, clinicians and industry. 

1.5.4.  Prospects for industrial nanotechnologies 

Despite  the  advances  in  characterisation  and  analytical  tools,  some  gaps  remain.  The 
incremental  improvements  in  silicon-based  electronics  and  improved  design  of  devices  are 
evident, while breakthroughs from bottom-up approaches (e.g. molecular electronics) are still 
in their infancy. The recommendation is to strengthen public-private partnerships and improve 
education in Europe. 

1.5.5.  Governance of nanotechnology 

–  Several interdependent concerns are expressed by industry, including ETPs, and European 
policy  makers,  in  research  and  development,  health,  environment,  consumer  protection, 
competitiveness, and so on. There is thus a need for a more effective European cooperation 
on horizontal nanotechnology issues, in particular standardisation; education; ethical, legal 
and societal aspects; and communication and outreach. 

–  Further dialogue and joint actions between governments, funding agencies, industries and 
research  entities  are  essential  in  achieving  a  prosperous  sustainable  economy  in  Europe. 
Only these interactions will overcome the barriers related to infrastructure and knowledge. 
They  are  vital  in  maximising  the  benefits  of  cooperative  research  in  nanosciences  and 
nanotechnologies.  Also  vital  is  a  dialogue  with  society  at  large,  in  order  to  overcome 
misconceptions created by ill-informed media comment. 

–  In order to support the continuing industrialisation of nanotechnology, the development of 
new products and services should be encouraged. And to respond to broad public demand 
for  safe  and  responsible  research,  a  larger  financial  support  and  wider  international 
cooperation are needed in the fields of safety, health and environmental protection. 

–  The  market  success  of  nanotechnology  applications  depends  very  much  on  the 
development and validation of measurement and testing methods and the establishment of 
the corresponding standards. 

International Collaboration in Nanotechnology Research 

1.6. 
All themes in the Cooperation  part  of  FP7  are open to the participation of third countries,95 
where this is justified in terms of the enhanced contribution made in this way to the objectives 
of  FP7.  Additionally,  participants  from  international  cooperation  partner  countries  (ICPCs) 
can receive EU funding. 

95 

That is, countries other than Member States and FP7 Associated States 

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In  the  NMP  Work  Programmes  in  particular,  some  research  topics  have  been  introduced 
specifically to address international collaboration, for example in the field of environmental, 
health  and  safety  impacts  of  engineered  nanomaterials.  The  international  participation  in 
nanotechnology projects of NMP was around 5 % in 2007-2008, with 84 participations from 
18 third countries. 

Further actions to promote international cooperation include: 

–  Coordinated  calls  to  address  objectives  of  mutual  interest  (for  example  with  countries 

having signed S&T cooperation agreements with the EU); 

–  Specific International Cooperation Actions (SICAs); 

–  Specific  initiatives  to  promote  the  participation  of  ICPCs;  these  include  technical 
workshops and other events to identify topics of mutual interest for future coordinated calls 
or SICAs; 

–  The development of internationally harmonised standards and nomenclature; 

–  Initiatives to coordinate and exchange research data (such as in environmental, health and 

safety issues for nanotechnologies); 

–  Dialogues  with  major  countries  on  a  “code  of  conduct”  for  the  responsible  and  safe 

development of nanotechnology; 

–  Coordinated actions with researchers in other world regions; and 
–  The Intelligent Manufacturing Systems (IMS) scheme.96 

1.6.1.  EU-US  collaboration  on  Environmental,  Health  and  Safety  Impacts  (HSE)  of 

engineered nanoparticles 

Two calls have specifically been targeted towards enhancing the EU-US collaboration in the 
field  of  HSE  impacts  of  engineered  nanoparticles.  The  first  NMP  call  of  FP7  included  the 
topic “Risk assessment of engineered nanoparticles on health and the environment”. Although 
this  topic  was  not  formally  within  a  coordinated  call,  the  call  text  strongly  recommended 
cooperation with US partners. As a result, three projects were selected for funding with a total 
of  eight  US  partners  (five  universities,  EPA,  NIOSH  and  the  US  Geological  Survey).  The 
second NMP call of FP7 included the topic “Impact of engineered nanoparticles on health and 
the  environment”,  and  the  call  text  again  recommended  cooperation  with  US  and  other 
international teams. Two projects were selected for funding with a total of seven US partners 
(three  universities,  EPA,  NIOSH,  NIEHS  and  the  Woodrow  Wilson  Centre).97  A  new 
coordinated  call  is  included  in  the  2010  Work  Programme  of  NMP  on  “Modelling  toxicity 
behaviour  of  engineered  nanoparticles”.  On  the  EU  side,  an  indicative  budget  of  EUR  6 
million is dedicated to this call, while on the US side a multi-agency solicitation (EPA, NSF, 

96 
97 

http://www.ims.org/ 
Although the US participation in proposals submitted in response to these calls has been encouraging, it 
must  be  noted  that  the  contract  negotiations  have  often  been  delayed because  of  issues  related  to  the 
legal provisions of the FP7 Grant Agreement. As a rule, the US partners are required to sign the FP7 
Grant  Agreement  even  though  they  do  not  receive  a  financial  contribution  from  the  Framework 
Programme. In some cases it has been discovered that because of domestic legislation or the FP7 IPR 
framework,  US  participants  have  been  unable  or  reluctant  to  sign  the  Grant  Agreement,  leading  to 
withdrawals  from  the  project.  The  situation  has  improved,  but  not  wholly  resolved,  after  the 
introduction  of  new  Special  Clauses  which  can  be  included  in  the  Grant  Agreement.  Currently 
negotiations are ongoing on a Coordinated Call, “Option 2”, which would result in “twin projects”. The 
EC  and  the  US  funded  projects  would  be  legally  separate,  but  coordinated  as  tightly  as  possible.  A 
coordination agreement between the two projects must be concluded to cover issues such as IPR. 

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NIESH, USDA, NIOSH) is being prepared on “Environmental and biological fate, transport, 
and transformation of engineered nanomaterials”. 

1.6.2.  Collaboration with ICPC countries 

As mentioned above, the number of ICPC participations in nanotechnology projects is fairly 
good, even though the low selection rates mean that this participation is somewhat scattered. 
Coordinated  calls  and  Specific  International  Cooperation  Actions  (SICAs)  can  lead  to  more 
targeted investment and impact, in addressing areas of mutual interest. The general goal is to 
boost  cooperation  with  both  developed  and  developing  countries.  A  number  of  coordinated 
calls  were  launched  in  the  last  year  of  FP6  and  the  first  years  of  FP7,  addressing  areas  of 
mutual  interest  to  the  EU  and  a  number  of  international  partners.  Amongst  these  ICPC 
partners,  one  can  cite  India  (on  computational  material  science)  and  Russia  (in  the  area  of 
sensors).  In  the  context  of  the  coordinated  call  with  India,  six  projects  have  been  launched 
with a total EU funding of EUR 5 million. 

The  2009  Work  Programme  of  NMP  included  a  coordinated  call  with  Russia  on 
nanotechnology-based sensors, with a total EU funding of EUR 4.65 million and comparable 
funding from the Russian Federation. Three specific applications were defined, the objective 
being to fund one project in each: 

–  Optical chemical sensing with nanoparticles, nano-waveguides and photonic structures; 

–  Wireless surface acoustic wave physical sensors for operation in a wide temperature range; 

and 

–  Sensing  of  toxic  and  explosive  agents  in  air  based  on  metal  oxide  semiconductor 

nanostructured materials.98 

A  further  topic  was  specified  for  a  support  action  on  the  “mapping  of  nanotechnology  and 
nanostructured  materials  research  infrastructures  in  Russia”,  with  EU  funding  of  EUR 
350,000.99 The projects resulting from the coordinated calls with Russia are expected to start 
by the end of 2009. 

The  2010  Work  Programme  of  NMP  includes  a  coordinated  call  with  Mexico  on  “adding 
value to mining at the nanostructure level”. The indicative EC budget for this call is EUR 6 
million; some of this is to be dedicated to participants from other ICPCs, from Latin America 
in particular, in an attempt to promote a regional approach in international cooperation. 

The proposals considered for funding are: 

98 
INGENIOUS  –  developing  novel  ultra-sensitive  and  selective  nanostructured  optochemical  sensors  for  the 
detection  of  PAHs  (polycyclic  aromatic  hydrocarbons)  and  BTX  (benzene,  toluene,  xylene)  from 
complex mixtures. Nanoparticle-based materials with high selectivity and sensitivity will be created for 
the  sensing  elements.  Application  areas  will  be  in  industrial  process  control,  occupational  health  and 
plants safety. 

SAWHOT – involving a new class of material, langasite, and its variant forms in substituting quartz and lithium 
niobate for research into new wireless SAW sensors operating in an unprecedented temperature range 
(from -20°C to +650°C). 

S3 – developing toxic and explosive gas sensing technologies with higher sensitivity and selectivity at reduced 

99 

cost, with sensing principles based on molecularly engineered semiconductor nanowires. 
The proposal considered for funding is NANORUCER, which will perform an analysis of strengths and 
weaknesses of the Russian nanotechnology innovation system, using bibliometrics and patent statistics 
and  a  mapping  of  research  activities  in  Russia  on  nanotechnology  and  nanostructured  materials.  A 
systematic  comparison  with  the  corresponding  EU  activities  should  help  identify  opportunities  for 
future EU-Russia cooperation. 

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The ICPC participation in EU-funded research is often limited because of insufficient contacts 
with  EU  researchers.  To  ameliorate  this  situation,  the  FP7  project  ICPC-Nanonet,100  with 
partners from the EU, China, India and Russia, aims to provide: 

–  an  electronic  archive  of  nanoscience  publications  that  is  freely  accessible  to  researchers 

around the globe; 

–  an electronic database of nanoscience organisations and networks in ICPC; 

–  links to nanoscience researchers and stakeholders across the globe; 

–  annual  reports  on  nanoscience  developments  in  eight  ICPC  regions:  Africa,  Caribbean, 
Pacific,  Asia,  Eastern  Europe  and  Central  Asia  (EECA),  Latin  America,  Mediterranean 
Partner Countries (MPC), Western Balkan Countries (WBC); 

–  on-line networking tools (forums and workshops); and 

–  annual workshops, one in each of EU, China, India, and Russia, which will also be webcast 

to facilitate greater access. 

Networking  projects  such  as  ICPC-Nanonet  are  expected  gradually  to  boost  the  ICPC 
participation in EU-funded nanotechnology research. 

Special  mention  should  be  made  of  the  topic  on  “Coordination  actions  with  materials 
researchers  in  major  world  regions”  in  the  2008  Work  Programme  of  NMP.  The  proposals 
selected  for  funding  in  this  topic  provide  EU  researchers  with  the  possibility  of  networking 
with major research players in third countries, reinforcing the international dimension of the 
FP7. 

1.6.3. 

International Dialogue on Responsible Development of Nanotechnology101 

The aim of this international dialogue is to promote cooperation with all countries interested 
in a responsible and sustainable development of nanotechnology. In particular, it provides a 
forum where the societal impact of nanotechnology can be explored. 

The dialogue is of an informal nature and high-level specialists can be invited depending on 
the  agenda  of  the  meetings.  It  is  strictly  complementary  to  other  global  forums,  never 
duplicating  what  is  done  competently  and  successfully  elsewhere,  but  paving  the  way  for 
formal discussions in selected areas. 

Building  on  the  previous  dialogues  of  2004  in  the  US  and  2006  in  Japan,  the  European 
Commission was pleased to organise the 3rd International Dialogue for Responsible Research 
and Development of Nanotechnology, which was held in Brussels on 11-12 March 2008 and 
gathered  97  participants  representing  49  countries,  as  well  as  international  organisations, 
industries and universities. 

The Third International Dialogue addressed: 

–  Nanotechnology governance, debating in more detail (i) the EU-US call for proposals on 
the impact of nanoparticles on health and the environment, as an example of international 
research on a topic of global interest; (ii) activities of leading international institutions and 
organisations; and (iii) the codes of conduct adopted or in preparation. How synergy can be 
improved  between  stakeholders  was  examined,  and  proposals  have  been  made  for  the 
exchange of good practises (e.g. on conditions at the workplace), as well as for coordinated 

100 
101 

http://www.icpc-nanonet.org/ 
Although the international dialogue is also relevant to other chapters of this report, it is presented here 
for the sake of completeness. 

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“observatory” activities, including indicators of responsible and sustainable innovation or 
the implementation of the codes of conduct. 

–  “Bridging the gap”, a very informative session illustrating various initiatives, in particular 
the  IBSA  initiative  (India,  Brazil,  South  Africa),  and  exploring  how  to  better  achieve  a 
meaningful  access  to  knowledge  by  all  countries,  in  the  so-called  North-South,  North-
North  or  South-South  cooperation.  Such  initiatives  deserve  further  attention  in  future 
meetings. 

–  Debating  the  progress  of  the  work  carried  out  by  the  OECD  working  parties  related  to 
nanotechnology,  as  well  as  the  challenges  of  metrology,  standardisation,  definitions  and 
intellectual  protection.  The  importance  of  launching  coordinated  activities  on  global 
challenges was highlighted, such as nanotechnology for water purification, environmental 
remediation, and sustainable development in general. Also highlighted were joint projects 
where the immediate industrial or commercial interest is not apparent, but the societal or 
environmental  benefits  are  considerable.  In  addition,  organisational  challenges  were 
addressed. 

–  Societal  engagement,  debating  the  experience  acquired  by  a  global  networking  of  social 
scientists and hearing the lessons learnt from dialogue with the public in different countries 
and  by  different  stakeholders.  The  value  of  information,  communication,  dialogue  and  a 
constant “listening mode” was consistently highlighted. Good practices were presented and 
debated. 

2. 

INFRASTRUCTURES 

The  availability  of  excellent  pan-European  Research  Infrastructures  (RIs)  with  critical  mass 
and  interdisciplinary  character  is  a  major  challenge  for  the  progress  of  R&D  and  industrial 
innovation in Europe. 

ESFRI  Roadmap:  The  European  Strategy  Forum  on  Research  Infrastructures  (ESFRI)  was 
mandated by the Competitiveness Council in 2004 to produce a roadmap for new RIs of pan-
European  relevance.  The  ESFRI  Roadmap  of  2006,102  with  its  2008  update,  represents  a 
fundamental  effort  that  addresses  the  needs  of  the  research  community  for  the  next  10-20 
years and catalyses a joint vision for new or upgraded RIs. 
PRINS103  is  a  pan-European  RI  for  nanostructures,  one  of  the  44  projects  identified  in  the 
ESFRI Roadmap. It is the infrastructure arm of a broader initiative, the ENIAC ETP (see sub-
section 1.4.1). It has been conceived as a distributed infrastructure, based on three European 
centres  of  excellence,  IMEC  (Belgium),  CEA-LETI  (France)  and  the  Fraunhofer  Group  for 
Microelectronics (Germany), which will jointly address the new challenges in a coordinated 
and  complementary  way  and  will  be  put  under  a  common  umbrella.  PRINS  will  bring 
together  an  unprecedented  array  of  equipment  and  know-how  in  topics  like  high  resolution 
lithography,  advanced  process  steps  and  modules,  electronic  systems  integration,  imaging 
devices, silicon-based micro-systems, and miniaturised “nano-bio” devices. The open access 
provided  to  the  scientific  community  by  PRINS  will  enable  innovative  research  and  a  truly 
cross-disciplinary  fertilisation  of  academic  and  industrial  competences.  It  should  allow 
progress  in  the  scaling  of  components  and  circuits  (e.g.  for  nanoelectronics,  nanophotonics 
and nanosystems) by allowing the convergence of “top-down” technology, which is today the 

102 
103 

ftp://ftp.cordis.europa.eu/pub/esfri/docs/esfri-roadmap-report-26092006_en.pdf 
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main  enabler  of  Moore’s  law,  with  “bottom-up”  methods  derived  from  disciplines  such  as 
materials science, chemistry, nanobiotechnology and particle electronics. 

PRINS  builds  on  the  FP6  projects  MNTE  and  STAR,  as  well  as  the  FP7  project  MNTEE. 
These projects supported the creation and upgrading of a unique distributed platform for R&D 
in micro and nanotechnologies. PRINS is now supported financially in its preparatory phase 
under FP7, with an EC contribution of EUR 1 million. The PRINS PP aims to involve all the 
stakeholders  necessary  to  make  the  project  move  forward;  to  make  decisions  on  the  legal 
structure, the operation mode and the governance model; and to make financial commitments 
before construction can start. The cost of the construction phase is currently estimated at EUR 
1.4 billion over the period 2009-2015. Member States are the key actors in the emergence of 
such  new  RIs,  since  the  EC  contribution  to  the  construction  costs  can  only  be  very  limited. 
Nevertheless, indirect participation in the construction costs is possible, by facilitating loans 
through  the  new  Risk  Sharing  Finance  Facility  (RSFF),  an  innovative  idea  of  leveraging 
Community funds available under FP7 through the European Investment Bank (EIB). There is 
also a possibility of making use of Structural Funds, but to a more limited extent. 
EUMINAfab:104  In  addition  to  supporting  the  development  of  new  RIs,  the  Commission 
supports existing RIs through the Integrating Activity (IA) model (the continuation of the FP6 
“I3” model). EUMINAfab is such an integrating activity, on “integrating European research 
infrastructures  for  micro-nano  fabrication  of  functional  structures  and  devices  out  of  a 
knowledge-based multimaterials repertoire”. The four-year project started in March 2009 with 
an EU contribution of EUR 6 million, and involves six academic and four industrial partners. 
It  supports  the  networking  of  existing  facilities,  providing  access  for  over  400  users  to  a 
unique  portfolio  of  36  state-of-the-art  installations,  and  performs  joint  research  activities  to 
improve the services offered to the users. EUMINAfab is expected to develop a knowledge 
management  system  for  multi-material  micro- and nano-processing; stimulate new technical 
approaches; and accelerate the convergence of miniaturised technologies in response to user 
requests. 
NFFA:105  The  Commission  also  supports  an  FP7  Design  Study  (DS)  on  “nanoscience 
foundries  and  fine  analysis”.  The  two-year  project  started  in  June  2008  with  an  EU 
contribution of EUR 1.8 million, and involves five research institutions. Its purpose is to study 
the  feasibility  of  a  new  kind  of  users’  infrastructure  for  nanoscience,  based  on  “foundry 
centres”  and  strongly  linked  to  the  large-scale  facilities  for  the  fine  analysis  of  matter.  The 
final cluster, forming the basis of the future RI, would consist of three to six centres closely 
attached  to  a  number  of  selected  European  facilities:  synchrotron  radiation  sources;  neutron 
scattering  sources;  high  power  lasers,  including  free  electron  lasers;  high  performance 
computing,  and  so  on.  The  objective  of  such  a  cluster  is  to  enable  researchers  to  access  to 
state-of-the-art  synthesis,  nanofabrication  and  analysis  tools.  NFFA  is  also  designing  a 
repository-type  data  bank  on  nanoscience.  Last,  but  not  least,  NFFA  aims  at  raising  the 
standard  of  sample  definition  and  characterisation  for  advanced  experiments  using  leading 
edge facilities. 

Contribution of Networks of Excellence: Beyond the dedicated activities described above, 
several  Networks  of  Excellence  (NoEs)  have  contributed  to  infrastructures  and  training  in 
nanotechnology. 

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http://www.euminafab.eu 
http://nffa.tasc.infm.it 

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The  experience  of  the  Nano2Life  NoE  is  expected  to  set  the  basis  of  a  future  European 
nanobiotechnology  institute,  focused  on  understanding  the  nanoscale  interface  between 
biological and non-biological entities, and its possible applications, such as eco-efficient and 
sustainable  products;  or  complex  and  integrated  novel  sensor  technologies  for  health  care, 
pharmaceuticals,  environment,  security  and  food  safety.  The  appropriateness  of  a  novel 
infrastructure in nanobiotechnology is being explored through a support action of FP7. 

The  Nanoquanta  NoE  addressed  the  quantum  mechanics  of  nanosystems  and  led  to  the 
creation of a virtual infrastructure, the European Theoretical Spectroscopy Facility (ETSF).106 
This  provides  computer  codes  and  expertise  for  the  analysis  of  the  excited  states  of 
nanosystems,  that  is,  their  electronic  and  optical  properties,  thereby  supporting  further 
research  and  industrial  applications.  ETSF  has  already  attracted  many  users,  including 
industrial ones. At the end of its funding under FP6 (NMP thematic priority), it was granted 
funding from the FP7 Capacities programme (e-Infrastructures). 

In  the  area  of  nanomaterials,  several  NoEs  have  led  to  durable  integration.  Examples  are 
IDECAT  in  catalysis,  INSIDE-PORES  in  nano-porous  materials,  and  NANOFUN-POLY  in 
polymer-based nanomaterials. 

Efforts of Member States: 

As described above, the PRINS project will develop an advanced RI for nanostructures based 
at  IMEC  (Belgium),  CEA-LETI  (France)  and  Fraunhofer  Group  for  Microelectronics 
(Germany).  Other  notable  initiatives  of  Member  States  are  the  new  International  Iberian 
Nanotechnology  Laboratory  in  Braga;  the  French  initiative  to  create  “nanotechnology 
integration centres” in Grenoble, Saclay and Toulouse; and the Gennesys  initiative  bringing 
together  European  neutron  and  synchrotron  facilities  for  research  in  nanotechnology 
applications. 
Through  the  Gennesys  initiative,107  led  by  the  Max  Planck  Institute,  a  large  consortium  of 
neutron  and  synchrotron  facilities  across  Europe  is  working  with  universities  and  research 
centres to bridge the gap between the research needs and future challenges in nanomaterials, 
and matching these with the latest neutron and X-ray techniques. 
With EC support, the VDI Technologiezentrum (VDI-TZ) produced “Nano-map”,108 showing 
the regional distribution of relevant national nanotechnology institutions in Germany, grouped 
by application field and technology. More than 1,200 institutions are shown, including major 
enterprises,  SMEs,  networks,  research  centres,  university  institutes,  associations,  and 
technology transfer and financing institutions. 

Coordination actions: 

Co-Nanomet is a programme of activities addressing the need within Europe to develop the 
measurement  frame  required  for  successful  support  to  the  development  and  economic 
exploitation of nanotechnology. Co-Nanomet’s activities focus on the nanometrology needs of 
European  industry  and  are  addressed  through  four  key  actions,  one  of  which  is  the 
exploitation and development of Infrastructures. 

106 
107 

http://www.etsf.eu/ 
Grand  European  Initiative  on  Nanoscience  and  Nanotechnology  using  Neutron  and  Synchrotron 
Sources, http://gennesys.neutron-eu.net/; Genesys report at 

http://www.mf.mpg.de/mpg/websiteMetallforschung/pdf/GENNESYS/GENNESYS_2009.pdf 
108 

http://www.nano-map.de/results/map.php 

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Given  the  high  level  of  investment  in  nanotechnology  capacity-building  across  Europe,  a 
in 
complementary  pan-European  view  of  organisations  and  associated  capabilities 
nanometrology  is  required.  The  Co-nanomet  programme  is  reviewing  current  capability, 
which it will signpost to potential users; and will make recommendations for the development 
of new nanometrology infrastructures across Europe. 
NanoImpactNet109  is  a  similar  coordination  action  in  the  area  of  risk  assessment.  It  will 
facilitate  collaboration  between  projects  on  the  health  and  environmental  impacts  of 
nanomaterials; communicate results to stakeholders and their needs back to researchers; create 
a  scientific  basis  to  ensure  the  safe  and  responsible  development  of  nanotechnology-based 
materials  and  products;  and  support  the  development  of  regulatory  measures  and 
implementation of legislation in Europe. 

An important future development is the inclusion, in the 2010 call for RI proposals, of a topic 
to integrate the RIs for the processing, analysis, characterisation and assessment of health and 
environmental impact of engineered nanomaterials, nanoparticles and nanostructures.110 Like 
NanoImpactNet,  this  action  is  expected  to  be  highly  relevant  to  the  research  on  risk 
assessment described in section 1.3 above. 

3. 

HUMAN RESOURCES 

A  new  generation  of  researchers,  engineers  and  skilled  workers  with  a  flexible  and 
interdisciplinary approach to R&D is necessary in making rapid progress in nanotechnology. 
The Commission recognises111 the need for the European economy to modernise in order to 
improve its competitive position. This requires a transition to a knowledge-based economy. 

There  is  a  particularly  urgent  need  for  training  young  researchers  in  Europe  in  different 
disciplines, with a focus on nanotechnology. Such an approach should also aim to train open-
minded  researchers,  so  that  they  can  work  with  various  disciplines  and  sectors,  and 
understand the link between fundamental and applied research. 

Also necessary is an understanding of market demands and the development of applications. 
This is another  aspect of  mobility, which should not only be geographical but also between 
disciplines and sectors. An effective programme for training and transfer of knowledge should 
be  established.  The  importance  of  technological  development  and  the  training  of  highly-
qualified technicians should also be considered. 

Marie Curie actions: 

The  general  purpose  of  Marie  Curie  actions  is  to  improve  the  career  prospects  of  new 
researchers, by offering structured training in specific S&T areas, and exposing researchers to 
other  sectors,  including  the  private  sector,  so  that  they  acquire  a  broad  perspective. 
Nanotechnology  has  attracted  the  interest  of  researchers,  as  evidenced  by  a  strong 
participation in EU-funded and other European activities. 

There  has  been  significant  support  for  training  in  nanotechnology  through  the  Marie  Curie 
actions of FP6, with grants of EUR 161 million, some 8 % of the total budget (even though 
funds  are  not  earmarked  for  any  particular  sector).  Training  activities  in  nanotechnology 
continue  to  receive  funding  under  the  People  programme  of  FP7,  with  grants  of  EUR  125 
million in 2007 and 2008. 

109 
110 
111 

http://www.nanoimpactnet.eu/object_class/nano_men_home.html 
topic INFRA-2010-1.1.31 
Towards a European Research Area, COM(2000)6 

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43 

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Some examples of Marie Curie projects offering training in nanotechnology follow: 

–  Initial Training Networks (ITN): 

NANO-HOST,  HERODOT, SOPRANO,  FINELUMEN,  ELCAT  and other projects provide 
training  through  research  on  nanomaterials,  such  as  nanostructured  catalytic  materials, 
nanocrystals, nanocomposites, nanostructured metals and metal-oxide interfaces. 

MAMINA,  MINILUBES  and  DENDREAMERS  offer  training  in  nanotribology  and 
nanomechanics  research,  nanoscale  surface  characterisation,  nanoporous  metallic  materials 
and nanohybrid materials. 

FUNMOLS  and  SEMISPINNET  offer  training  in  nanodevices.  FUNMOLS  also  provides 
training in environmental, socio-economic and policy aspects of nanotechnology. 

FANTOMAS provides training in nano-opto-magnetism, an emerging field at the interface of 
coherent non-linear optics, nanophotonics and nanomagnetism. 

BIOMINTEC provides training in nanobiotechnology. 

HIERARCHY offers a broad training programme in nanosciences and applications. 

–  Research Training Networks (RTN): 

NESPA offers training in nano-engineered superconductors for power applications. 

NANOMATCH  provides  training  in  nanomaterials,  particularly  in  nanostructured  organic-
inorganic hybrid systems. 

RTNNANO focuses on hybrid nanostructures and nanoelectronics. 

NASCENT offers training in nanomaterials for applications in sensors and catalysis. 

COMSON offers training in simulation and optimisation in nanoelectronics. 

–  Early Stage Training (EST): 

QIPEST provides training in nanodevices and nanomaterials. 

NANOCAGE  offers  training  in  a  very  broad  range  of  techniques  used  extensively  in 
nanoscale and condensed matter science. 

NANOTIME offers training in nanostructured superconductors. 

The training programmes of nanotechnology-related Marie Curie projects address two major 
requirements  for  future  researchers:  First,  researchers  must  be  able  to  cope  with  complex, 
interdisciplinary  problems  and  analyse  them  in  terms  of  their  chemical,  physical  and 
technological  aspects.  Second,  researchers  need  to  combine  a  wide  knowledge  of  materials, 
concepts  and  disciplines  in  order  to  find  adequate  solutions  to  challenges  that  are  raised  in 
market-driven  research.  Nanotechnology-related  Marie  Curie  projects  provide  complex  and 
multidisciplinary  research  training  with  contributions  from  chemistry,  physics,  biology, 
materials  science,  mechanical  engineering,  opto-electronics,  mathematics,  modelling  and 
simulation. 

Also covered are ethical, socio-economic and policy issues, and public outreach. The diverse 
applications of nanotechnology can increase people’s interest in science and technology. It is 
therefore  an  attractive  topic  for  television  documentaries,  articles  in  newspapers  or  popular 
science  magazines,  and  lectures  for  non-specialists.  Many  Marie  Curie  projects  use 
opportunities to communicate their research results in these ways. 

There  are  close  links  to  the  innovation  efforts  of  European  companies:  Industrial  partners 
directly  support  the  transfer  of  the  results  into  industrial  applications.  Collaboration  with 

EN 

44 

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industry provides a way of focusing current research efforts, to facilitate the transfer of results 
to  industrial  use.  The  aim  is  to  reduce  the  existing  gap  between  academically  developed 
technologies  and  their  industrial  applications.  Commercialisation  of  academic  knowledge  is 
often  difficult,  but  the  industrial  presence  in  networks,  combined  with  the  expertise  of  the 
academic  host  institutions  in  setting  up  spin-off  companies,  offers  opportunities  to  generate 
commercial output from the projects. 

In Europe, several excellent research teams exist in nanotechnology, but there is a significant 
fragmentation in the area, because of the existence of separate scientific communities and the 
in 
identity.  Marie  Curie  projects  address 
absence  of 
nanotechnology research, creating a coherent framework of research, know-how and training 
between  the  various  research  communities,  with  the  objective  of  achieving  a  lasting 
integration between the main European institutions in the area. 

the  fragmentation 

thematic 

Other Commission activities in education: 

The  training  activities  funded  by  the  Commission’s  lifelong  learning  programme  and  the 
corresponding  international  activities  can  support  training  in  nanotechnology.  So  far,  the 
Erasmus Mundus Programme has supported Masters degrees in three nanotechnology areas112 
(although  there  have  been  no  new  projects  since  2007).  Novel  technologies  including 
nanotechnology  have  been  singled  out  in  the  Commission’s  Communication  New  Skills  for 
New Jobs.113 In June 2008, the European Institute of Innovation and Technology114 (EIT) was 
set up. The first call for the so-called Knowledge and Innovation Networks115 (KICs), which 
will constitute the EIC, covers climate change mitigation and adaptation, sustainable energy 
and  the  future  information  and  communication  society  –  all  being  areas  of  application  in 
which nanotechnology can make important contributions. 

Contribution of Networks of Excellence and Integrated Projects: Although all EU-funded 
research  projects  may  be  deemed  to  include  an  element  of  training  for  new  researchers  in 
nanotechnology, one should single out the Networks of Excellence of FP6 (NoEs) and some 
Integrated Projects, which made valuable contributions in this area. 

The Nano2Life NoE, which addressed nanobiotechnology, involved 200 scientists, engineers 
and medical doctors. It contributed to training by bridging the worlds of nanotechnology and 
biotechnology, by developing a curriculum and tutorials, and by organising summer schools. 

The  Nanoquanta  NoE  addressed  the  quantum  mechanics  of  nanosystems  and  led  to  the 
creation of a virtual infrastructure, the European Theoretical Spectroscopy Facility (ETSF). It 
organised a total of eleven training schools, along with many more scientific conferences and 
workshops  (including 
innovative  annual  Nanoquanta-ETSF  Young  Researchers’ 
Meeting). More than fifty PhD students were trained collaboratively within the network’s own 
groups. 

the 

The Nanobeams project created a European PhD School on characterisation techniques using 
ion and electron beams.116 

112 

113 
114 
115 
116 

http://www.emm-nano.org/ 
http://www.u-picardie.fr/mundus_MESC/ 
http://www.ens-cachan.fr/monabiphot/ 
New Skills for New Jobs - Anticipating and matching labour market and skills needs, COM(2008)868 
http://eit.europa.eu/ 
http://eit.europa.eu/kics-call.html 
https://www.nanobeams.org/ 

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Within  the  Nanoker  Integrated  Project,  three  external  training  programmes  will  be 
developed,117  in  biomaterials,  optics  and  extreme  conditions.  Their  objectives  are:  (i)  to 
develop a sense of the underlying complex material response in specific applications and the 
required  multi-functionality  of  solutions  required  in  biomaterials,  optics  or  extreme 
conditions; (ii) to provide training in the fields of materials modelling, design, analytical and 
experimental  methods,  specific  to  understanding  the  behaviour  of  materials  under  complex 
conditions; and (iii) to acquaint scientists and engineers with new processing methods which 
allow  the  synthesis  of  multi-functional  nanomaterials.  One  event  specifically  addressed 
workplace and environmental safety.118 
The NanoHand Integrated Project119 involved most research institutes with experience in the 
field of micro-robotics and nano-handling, the biggest semiconductor company in Europe, and 
a number of dynamic nanotechnology SMEs. Its main objective was to deliver the technology 
needed  for  the  control  of  nano-objects  in  an  automated,  controllable  and  safe  environment. 
The main outcomes of the project will be demonstrators, including basic hardware, software 
and  the  necessary  processing  strategies.  These  demonstrators  involve  robotic  production 
systems inside scanning electron microscopes. Such “nano-robotics” will perform controlled 
and even automated processing using nanoscale tools, allowing for example carbon nanotubes 
to be placed as components anywhere in an integrated circuit to replace ordinary components, 
or to form altogether novel devices that cannot be produced using conventional methods. The 
short  term  perspective  (CNT-decorated  SPM  tips)  provides  technology  enabling  further 
advances  to  be  made  in  AFM  (atomic  force  microscopy).  This,  in  turn,  will  foster  the  long 
term objective of the project, to handle and assemble nanosized objects in the construction of 
nanoelectronic  devices  and  other  uses.  Moreover,  a  Masters  course  in  “nano-manipulation” 
was developed. 

Other training activities: 

Two major projects address training in nanoelectronics: To bridge the widening gap between 
the  state  of  the  art  of  European  academia  and  that  of  leading  industry,  the  IDESA  support 
action  develops  training  material  on  the  design  flow  for  integrated  circuits  employing 
advanced  deep  sub-micron  technologies,  and  makes  it  available  free  of intellectual property 
rights.  The  EUROPRACTICE  support  action  is  widely  recognised  as  a  world-class  service 
offering affordable state-of-the-art CAD tools for educational use and advanced technologies 
for prototyping. 550 European universities and 50 research centres are using the service. 
In the important area of risk assessment, the NanoSMILE120 activities within the Nanosafe2 
project  were  designed  to  provide  information  and  training.  These  cover  potential  risks, 
exposure  and  dosimetry,  and  potential  impact  on  health  and  the  environment.  The 
NanoImpactNet  coordination  action  also  provides  training  in  this  area,  with  a  series  of 
workshops and schools on human and environmental hazards and impact assessment. 

Some  European  Technology  Platforms  include  training  in  their  activities:  SusChem,  for 
example,  developed  an  “education  database”,121  because  the  long-term  success  of  the 

117 
118 

119 
120

121 

http://www.nanoker-society.org/index.aspx?id_page=140&ID_Elemento=235 
http://www.nanoker-
society.org/index.aspx?ID_Page=158&ID=365&ID_Plantilla=301&TIPO=asyContenido 
http://www.nanohand.eu 

http://www.nanosafe.org/scripts/home/publigen/content/templates/show.asp?P=68&L=EN&IT

EMID=19 
http://learning.suschem.org/ 

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European chemical industry depends on attracting and retaining the best students from school 
through  to  higher  education.  The  objectives  of  this  education  database  are  to  provide 
information  and  courses  (from  secondary  school  to  PhD  level)  in  the  field  of  sustainable 
chemistry;  assist  in  the  development  of  new  courses;  and  promote  new  collaborative 
activities. 

4. 

INDUSTRIAL INNOVATION 

Economic  globalisation  has  changed  the  world,  bringing  new  opportunities  and  new 
challenges.  In  this  new  situation,  Europe  cannot  compete  unless  it  becomes  more  inventive 
and innovative. Europe’s citizens are concerned about important issues ranging from climate 
change and the depletion of non-renewable resources, to demographic change and emerging 
security needs, all of which call for collective action to safeguard the European way of life, 
which  combines  economic  prosperity  with  solidarity.  These  legitimate  concerns  must  be 
turned into an opportunity to enhance Europe’s global economic competitiveness. The quicker 
it can react, the higher the chance of success and the greater prospect that its approach will 
serve as a global model. From the protection of the environment through eco-innovation to the 
improvement  of  individual  well-being  through  more  intelligent  infrastructure  provision,  the 
Commission  is  convinced  that  innovation  in  a  broad  sense  is  one  of  the  main  answers  to 
people’s material concerns about their future. 

The  European  Union  has  an  extraordinary  innovation  potential.  Europe  has  a  long-standing 
tradition of  breakthrough inventions.  It has a wealth  of  creative  people  and  can  build  on  its 
cultural diversity. It has laid the basis for one of the largest single markets in the world, where 
innovative  products  and  services  can  be  commercialised  on  a  large  scale.  It  also  has  a 
tradition of a strong and responsible public sector, which should be capitalised on. 

4.1. 

General situation 

Notwithstanding the large public support for European nanotechnology, private investment in 
nanotechnology R&D remains low compared to Europe’s main competitors (see section 1.1). 
In fact, the number of new nanotechnology companies created over the last 25 years and still 
active is significantly lower in Europe than in North America (US and Canada combined). In 
particular, the number of nanotechnology start-ups is several times higher in North America 
than  in  Europe.  Moreover,  the  majority  of  European  nanotechnology  companies,  mainly 
located in Germany and the United Kingdom, are much smaller in terms of turnover than their 
counterparts in the US. With fewer and smaller nanotechnology companies, research efforts in 
the private sector are bound to be smaller in Europe than in North America. 

It is not surprising, therefore, to find that North America is the most active region in the world 
for registering patents in nanotechnology. In 2003, American applicants registered about 1200 
nanotech patents, compared with slightly more than 400 from European applicants. Moreover 
other countries, such as China, India and the Russian Federation in particular, are emerging in 
the field of nanotechnology. Although they may still lag behind on most indicators, they are in 
a  position  to  expand  and  bridge  the  gap  with  Europe.  They  will  probably  become  serious 
competitors  on  the  world  market  and  attractive  locations  for  research  activities.  European 
industry  has  yet  to  build  upon  the  strong  and  competitive  European  science  base  in 
nanotechnology and to increase its research efforts. The nanotechnology field is undoubtedly 
a  very  good  example  of  Europe’s  difficulty  in  translating  science  into  innovation,  and  in 
creating innovative products and commercial activities from scientific results. This difficulty 
is revealed by the massive gap in Europe between  the  development of  the  science  base and 
that of the nanotechnology industry. 

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Statistical  data,  including  a  general  analysis  for  nanotechnology,  can  be  found  in  the 
publications on key figures for the European Research Area (ERA).122 

4.2. 

General innovation policy applicable to nanotechnology 

Generating  new  knowledge  and  turning  it  into  new  products  and  services  is  crucial  to 
maintain and enhance Europe’s competitiveness. Academia and industry should work closely 
together and maximise the social and economic benefits of new ideas. Transforming research 
results  into  new  commercial  products  is  a  complex  process,  involving  a  broad  range  of 
stakeholders. If Europe is to operate as a single market for knowledge, it is not enough simply 
to  increase  public  investment  in  research;  rather,  it  is  important  to  create  a  framework  that 
facilitates  knowledge  transfer  by  removing  the  barriers  hindering  collaboration  between 
research and industry. 
The Commission has a broad innovation strategy.123 The 2006 Communication on innovation, 
“Putting  knowledge  into  practice:  A  broad-based  innovation  strategy  for  the  EU”,124  points 
the  way 
innovation  with 
competitiveness  and  public  policies  at  all  levels,  as  a  core  element  of  the  renewed  Lisbon 
strategy  for  growth  and  jobs.  The  Communication  singles  out  ten  priority  actions  in  a 
roadmap for action at the national and European levels. These include an improved transfer of 
knowledge between public research institutions and third parties, including industry and civil 
society organisations. 

industry-led  and  society-driven 

to  accompany 

forward 

The  Commission  calls  upon  Member  States  to  make  the  structural  reforms  necessary  to 
deliver the results required. In the context of the Lisbon strategy, the Commission has adapted 
its  state  aid  framework  to  enable  Member  States  to  develop  new  measures  favouring  the 
support  of  innovation,  taking  into  account  the  identified  shortcomings  in  this  domain.  This 
should also encourage Member States and regions to redirect state support, for instance from 
structural funds, towards activities that are most directly relevant to the Lisbon agenda. 

Other key documents on innovation policy are as follows: 

–  Commission  Recommendation  on  the  management  of  intellectual  property  in  knowledge 
transfer  activities  and  Code  of  Practice  for  universities  and  other  public  research 
organisations;125 

–  Commission  Communication  on  Improving  knowledge 

transfer  between  research 

institutions and industry across Europe: embracing open innovation;126 

–  Voluntary guidelines for universities and other research institutions to improve their links 

with industry across Europe, accompanying the Communication above;127 

http://ec.europa.eu/enterprise/innovation/index_en.htm#2 
COM(2006)502; 

122 
ERA key figures 2007, http://ec.europa.eu/invest-in-research/pdf/download_en/keyfigures_071030_web.pdf; 
ERA key figures 2008-2009, http://ec.europa.eu/research/era/pdf/key-figures-report2008-2009_en.pdf; 
and more for earlier years at http://ec.europa.eu/invest-in-research/monitoring/statistical01_en.htm 
123 
124 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2006:0502:FIN:en:PDF 
125 
http://ec.europa.eu/invest-in-research/pdf/ip_recommendation_en.pdf 
126 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0182:FIN:en:PDF 
127 
http://ec.europa.eu/invest-in-research/pdf/sec2007449_en.pdf 

COM(2007)182; 

SEC(2007)449; 

C(2008)1329; 

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–  Commission Communication on More Research and Innovation - investing for growth and 

Employment: A Common Approach.128 

In response to a request from the Council Working Party on Competitiveness and Growth, the 
Commission services prepared a Progress Report on the broad-based innovation strategy for 
the  EU  and  the  nine  strategic  priorities  for  innovation  action  outlined  in  the  Council 
conclusions of December 2006. 
The Commission’s “Competitiveness and Innovation Programme 2007-2013” (CIP),129 with a 
budget of about EUR 3.6 billion, complements FP7 in supporting innovation, with small and 
medium-sized enterprises (SMEs) as its main target. The programme will support innovation 
activities  (including  eco-innovation),  provide  better  access  to  finance  and  deliver  business 
support services in the regions. It will encourage a better take-up and use of information and 
communications  technologies  and  help  to  develop  the  information  society.  It  will  also 
promote  the  increased  use  of  renewable  energies  and  energy  efficiency.  The  CIP  is  divided 
into  three  operational  programmes:  Entrepreneurship  and  Innovation  Programme  (EIP); 
Information  Communication  Technologies  Policy  Support  Programme  (ICT  PSP);  and 
Intelligent Energy Europe  (IEE).  Nanotechnologies are relevant to all three because of their 
enabling nature. 

When  considering  Community  funding  opportunities  for  research  and  innovation  in 
nanotechnology,  it  is  important  to  make  the  best  use  of  the  existing  financial  instruments, 
namely FP7, CIP and the Structural Funds of the Cohesion Policy, keeping in mind that they 
can  be  combined  to  fund  successive  phases  of  the  same  project  or  related  projects.  For 
instance,  in  the  period  2007-2013,  a  total  of  EUR  86  billion,  or  25  %  of  the  Structural 
Funds,130  was  allocated  to  the  broad  innovation  agenda,  including  support  to  research, 
innovative  businesses  and  clusters,  entrepreneurship  measures,  innovative  ICT  and  human 
resources. These allocations can contribute to the development of nanotechnology, provided 
that  projects  meet  the  priorities  of  the  operational  programmes  aiming  at  regional 
development.  For  example,  just  over  EUR  21  million  was  invested  in  the  Centre  for  Nano 
Health (CNH) at Swansea University (UK) under the Convergence Objective of the Structural 
Funds. 

An overview of some innovation activities follows: 
ProTon  Europe,131  a  pan-European  network  of  knowledge  transfer  offices,  was  created  in 
2003 by the Commission and has been self-supporting since 2007. This network consists of 
over 220 Knowledge Transfer Offices (KTOs) and 10 National Partner Associations. ProTon 
Europe  reaches  out  to  almost  600  universities  and  public  research  organisations  across 
Europe.  Activities  addressing  nanotechnology  included  the  2008  ProTon  Europe  Annual 
Conference,  which  helped  form  effective  partnerships  as  an  essential  part  of  successful 
knowledge transfer deals. 

COM(2005)488; 

128 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2005:0488:FIN:en:PDF 
129 
http://ec.europa.eu/cip/index_en.htm; 
CIP Work Programme, http://ec.europa.eu/cip/cipwp.htm 
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131 

http://ec.europa.eu/regional_policy/atlas2007/index_en.htm 
http://www.protoneurope.org 

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Technology  Innovation  International  (TII)132  is  a  wide  network  of  innovation  and 
technology  transfer  specialists,  whose  members  provide  support  services  to  firms,  with  the 
ultimate aim of developing the knowledge economy and boosting the wealth creation process. 
Enterprise  Europe  Network133  offers  support  and  advice  to  businesses  across  Europe  and 
helps them make the most of opportunities in the EU, with emphasis on SMEs. 
Europe INNOVA134 is a Commission initiative, which aspires to become the laboratory for 
the development and testing of new tools and instruments in support of innovation, with the 
view to helping innovative enterprises innovate faster and better. It brings together providers 
of support on public and private innovation, such as innovation agencies, technology transfer 
offices, business incubators, financing intermediaries, cluster organisations and others. Within 
Europe  INNOVA,  one  can  mention  the  Finnish  co-operation  network  for  Micro  and 
Nanotechnologies and Adaptive and New Materials. 
Pro  Inno  Europe135  is  another  Commission  initiative  aiming  to  become  the  focal  point  for 
innovation policy analysis, learning and development in Europe, promoting learning from the 
best and contributing to the development of new and better innovation policies in Europe. 

4.3. 

Opportunities in particular technology sectors 

This  section  deals  with  particular  application  areas,  outlining  underlying  technologies,  their 
maturity, opportunities and risks. 

Recognising the fact  that  developments in nanomaterials will  lead to applications in several 
different technology sectors, the NanoRoadSME project was funded to develop roadmaps and 
encourage a knowledge-based approach in SMEs. It produced a report entitled “Overview on 
Promising Nanomaterials for Industrial Applications”.136 

Although  nanotechnology-related  products  are  already  on  the  market,  most  areas  of 
nanotechnology are still  in  the basic research stage. Analyses of potential markets are often 
vague  and  inconsistent;  nevertheless,  market-relevant  applications  can  be  expected  in  the 
fields  of  optics,  precision  engineering,  analytics,  chemistry,  automotive  and  mechanical 
engineering, materials management and medical engineering, pharmaceutics and biology. 

The  analysis  of  worldwide  research  activities  has  shown  that  several  types  of  funding  are 
needed: public funding of both basic research and application-driven research; funding for the 
development of marketable products; and venture capital funds for the establishment of start-
ups and spin-offs. It is also recognised that targeted public funding lays a solid foundation for 
future competitiveness, since it enhances the technological basis and human resources. 

An  example  is  the  area  of  ceramics:  An  analysis  of  the  state  of  the  art  shows  that  realistic 
market  opportunities  exist  for  nanopowders,  primarily  in  those  areas  where  materials  with 
novel property combinations – or at least with remarkably improved tribological, mechanical 
or  corrosion  properties  –  can  be  produced.  Through  the  use  of  nanopowders,  the  current 
disadvantages  of  ceramics,  which  are  generally  persistent  at  high temperatures  and result in 
low defect tolerance of ceramic materials and parts – especially the high brittleness – can be 
minimised.  In  this,  as  in  other  technologies,  realising  the  market  potential  will  only  be 

132 
133 
134 
135 
136 

http://www.tii.org 
http://www.enterprise-europe-network.ec.europa.eu/index_en.htm 
http://www.europe-innova.org/index.jsp 
http://www.proinno-europe.eu/index.cfm?fuseaction=page.home 
http://www.nanoroad.net/download/overview_nanomaterials.pdf 

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possible if the processes are controllable, the properties are reproducible and the production 
volumes are sufficiently high to make costs competitive. 

Further  analyses  of  market  opportunities  are  needed.  The  Commission  is  funding  a  large 
support  action,  ObservatoryNANO,137  over  four  years  from  2008  to  2012,  with  the  aim  of 
providing  stakeholders  with  assessments  of  opportunities  and  risks  within  a  wide  range  of 
application  sectors,  and  enabling  them  to  understand  the  potential  and  critical  issues.  The 
following  technology  sectors  are  covered:  (1)  Aerospace,  Automotive  and  Transport;  (2) 
Agrifood;  (3)  Chemistry  and  Materials;  (4)  Construction;  (5)  Energy;  (6)  Environment;  (7) 
Health, Medicine and Nanobiotechnology; (8) Information and Communication Technologies; 
(9) Security; and (10) Textiles. 

To  offer  wider  access  to  published  nanotechnology  research,  and  opportunities  for 
collaboration between researchers in the EU and International Cooperation Partner Countries 
(ICPC), the Commission is also funding an open-access electronic archive of publications and 
patents, ICPC NanoNet.138 

An outline of industrial possibilities in various sectors follows. 

4.3.1.  Nanomaterials for Electronics and Photonics 

The  R&D  aspects  of  nanomaterials  and  nanotechnology  in  electronics  and  photonics  are 
described in sub-sections 1.2.1-1.2.2; and 1.4.1-1.4.2. 

Nanoelectronics is an enabling technology for all electronic products and services. Logic and 
memories make up for most of the nanoelectronics market. In addition to its direct economic 
value, the semiconductor industry is one of the biggest investors in R&D, with typical budgets 
ranging  from  15  %  to  20  %  of  revenue.  Regional  clusters  with  a  high  density  of 
semiconductor industries are also the areas with the highest rate of patenting activity. 

Nanoelectronics  can  be  defined  as  electronics  on  the  deep  submicron  level  –  that  is,  with 
circuit  dimensions  of  less  than  100  nm.  The  term  covers  both  the  manufacturing  of  ever-
smaller semiconductor devices, and advances in molecular electronics exploiting single atoms 
or  molecules.  Semiconductor  chips  with  nanoscale  features  are  already  in  production.  The 
majority  of  electronic  devices  now  consist  of  complementary  metal  oxide  semiconductor 
(CMOS) circuits on silicon wafers, and there is much experience in their low-cost production. 
Because of its advantageous characteristics and future development potential, experts predict 
that  CMOS  will  remain  the  mainstream  technology  for  many  years  and  improvements  will 
continue  until  at  least  2016.  Short  to  medium-term  developments  will  be  based  on  silicon 
technology. 

New nanomaterials – from carbon nanotubes to organic polymers – are being investigated for 
a wide range of applications, including smaller, flexible displays and more powerful storage 
devices. Long-term developments of integrated circuits are expected to go beyond the existing 
silicon CMOS paradigm. This includes alternative schemes to encode information (new logic 
devices)  to  enable  computing  at  low  power  consumption;  inventing  and  developing  new 
information  processing  technology;  and  managing  heat  transfer  more  efficiently  through 
phonon technology. The current process for integrated circuit fabrication – lithography – may 
be  improved  by  immersion  lithography,  computational  methods  and  extreme  ultraviolet 
lithography.  There  are  also  a  number  of  wholly  new  technologies  for  nanoscale  fabrication, 
including  dip-pen  lithography  and  nano  imprint  lithography.  Efforts  are  made  to  develop  a 

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http://www.observatorynano.eu/project/ 
http://www.icpc-nanonet.org/ 

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“universal memory”: one which exceeds the capacity and cost effectiveness of flash memory, 
whilst maintaining its non-volatility, and improving on the data transfer speed of conventional 
random  access  memory.  A  further  impact  of  nanomaterials  is  in  displays  for  televisions, 
portable devices, and other applications; organic LEDs (OLEDs) have already received much 
attention,  but  there  are  also  efforts  to  produce  thin-film  transistors  using  carbon  nanotubes. 
Longer term development areas include technologies such as FED and SED, which rely on the 
field emissive properties of carbon nanotubes. 

Moreover, the use of nanoelectronics for the detection of biomolecules has resulted in a range 
of biochips for routine biomedical diagnosis and the mass screening of patients. A typical use 
is in transplant surgery, where organs run the risk of being rejected by the patient’s immune 
system. This risk can be characterised by DNA testing, and the new biochips will allow faster, 
cheaper  and  more  complete  testing  of  organs  and  recipients  to  get  a  better  match  in  time-
critical situations.  

Finally,  photonic  components  for  applications  such  as  optical  networking  and  photonic-
electronic integration are being developed. 

4.3.2.  Nanomaterials for the Medical Sector 

The  value  of  the  market  for  pharmaceuticals  and  medical  devices  is  difficult  to  assess; 
estimates range from at least EUR 18 billion, for the European market alone,139 to more than 
EUR 500 billion for the global market.140 The R&D aspects of nanomedicine are described in 
sub-sections  1.2.3  and  1.4.3.  Although  several  issues  have  to  be  overcome,  the  use  of 
nanomaterials will have a considerable impact on the medical sector. Impacts are expected in 
diagnostics including imaging and point-of-care diagnostics; targeted drug delivery; coatings 
for implants and surgical instruments; drug discovery; and tissue engineering. 

Many different nanomaterials are presently used in clinical or pre-clinical trials: 

–  Nanoparticles  with  magnetic  or  supermagnetic  properties;  titanium  dioxide;  iron  oxide; 

proteins or peptides; gold; silver; fluorine; manganese; functionalised metal; ligands. 

–  Nanotubes (used as container for drug delivery). 

–  Fullerenes (e.g. a modified fullerene is entering clinical trials as an anti-HIV agent). 

–  Quantum dots (e.g. cadmium selenide core surrounded by a shell of zinc sulphide, for its 

fluorescence). 

–  Dendrimers. 

–  Nanocapsules. 

–  Nanoparticle suspensions. 

–  Nanoemulsions. 

–  Nanocomposites of titanium alloys. 

–  Nanocoatings of titanium or tantalum. 

–  Nanoshells. 

–  Antibodies attached to nanoshells. 

–  Nanocrystals (e.g. zinc oxide). 

139 
140 

NanoRoadSME project  
vision paper of the Nanomedicine ETP 

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–  Nanobiotechnology-based drugs, with a nucleus of iron oxide and an antibody. 

–  Calcium phosphate (CAP) vaccines. 

–  Nanoporous materials; nanopores. 

–  Nanoporous electrode material and nanosized electrodes. 

–  Nanosized metal colloidal particles. 

–  Nano-calcium phosphate cements (CPC, nanocement). 

–  Composites of nanoclays. 

–  Nanostructured polymer based scaffolds. 

–  Amphiphilic molecules. 

–  Supramolecular nanomaterials. 

–  Nanoscale colloidal particles. 

4.3.3.  Nanomaterials for the Energy Sector 

The main challenges to be addressed by applications of nanomaterials in the energy sector are 
improvements in efficiency, product reliability, safety and lifetime, and the reduction of costs. 
Three  application  domains  can  be  identified  in  this  sector:  (a)  energy  conversion  and 
production; (b) energy storage; and (c) energy saving. 

The  most  promising  applications  in  energy  conversion  are  photovoltaics  (solar  cells), 
hydrogen  conversion  (fuel  cells),  and  thermoelectricity  (thermoelectric  devices).  Solar  cells 
will  be  of  interest  for  local  energy  supply,  if  the  costs  can  be  significantly  reduced  and 
efficient methods for storing electrical energy are available. Cost reduction is expected from 
dye-sensistised  solar  cells  and  organic  polymer  solar  cells.  Although  nanotechnology  may 
allow  a  breakthrough,  these  types  of  solar  cells  are  still  in  the  research  and  development 
phase.  The  use  of  fuel  cells  is  currently  limited  because  of  high  costs.  However, 
improvements brought about by nanotechnology, in membranes, catalysts and electrodes, will 
lower the cost of low-temperature fuel cells while also improving their efficiency. A potential 
market is the automotive industry, but suitable fuel cells remain in the R&D phase. Finally, 
nanostructured materials may be used in thermoelectric devices for recovering waste heat. 

For  energy  storage,  the  most  promising  developments  relate  to  rechargeable  batteries  and 
supercapacitors.  In  rechargeable  batteries  (for  example  lithium  batteries),  nanocrystalline 
materials and nanotubes used as electrode materials have been shown to improve both energy 
and power density, and also lifetime and charging rates. The miniaturisation of electrodes is a 
key objective. As in rechargeable batteries, advances in supercapacitors are expected through 
the use of nanoporous electrode materials. Nanotechnology will open new potential markets 
for  batteries  and  supercapacitors,  or  combinations  of  the  two  (e.g.  in  mobile  phones  and 
portable computers). 

Interesting  energy-saving  applications  are  expected  in  the  fields  of  insulation  and  efficient 
lighting.  Advances  in  insulation  brought  about  by  nanotechnology  will  help  reduce  energy 
demand and the daily costs in homes and industry. Such advances will be aerogels or smart 
glazes  in  the  form  of  ultra  thin  layers.  In  the  field  of  more  efficient  lighting,  LEDs  and 
OLEDs141  based  on  nanotechnology  are  expected  to  improve  energy  efficiency  and  have  a 
large market impact. 

141 

Organic light emitting diodes or light emitting polymers (LEPs) 

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Some examples of nanomaterials used in the energy sector are: 

–  Nanolayers, such as colloids, organic dye molecules, tungsten trioxide and zinc oxide, for 

aerogel and smart glass applications; 

–  Indium gallium nitride for inorganic LEDs; 

–  Organic nanolayers and nanostructured polymer films for small-molecule LEDs; 

–  Metal  oxide  nanomaterials,  nanoporous  metal  oxides  or  ceramics,  and  nanocomposite 

coatings, for nanotube LEDs, fuel additives and catalysts. 

4.3.4.  Nanomaterials for the Environment Sector 

Conventional  remediation  technologies  have  so  far  shown  only  limited  effectiveness  in 
reducing the levels of pollutants – especially in soil and water. Nanomaterials will be able to 
perform significantly better because of their much greater surface area. Various applications 
have  been  successfully  demonstrated  at  the  laboratory  scale,  but  most  of  them  still  require 
verification  of  efficacy  and  safety  in  the  field  and  are  thus  still  far  from  market.  Further 
research is also needed to assess the environmental impact of the nanoparticles released. One 
way  of  minimising  the  probability  of  exposure  is  to  encapsulate  the  nanomaterial  within  an 
inert barrier (e.g. silicon can be used to coat quantum dots) or to immobilise nanostructures 
onto  a  surface.  Employing  such  methods  can  maintain  the  activity  and  functionality  of  the 
nanomaterial while minimising the probability of nanoparticle dispersion. 

4.3.5.  Nanomaterials for the Automotive Sector 

Some  new  cars  already  incorporate  nanotechnology.  From  nanotubes  in  fuel  lines,  to 
nanoparticles  in  scratch-resistant  glass  coatings  or  as  fuel  additives  to  improve  fuel 
combustion efficiency, nanotechnology has started to enter the transport sector. The sector is 
benefiting  from  the  development  of  cost-effective  production  technologies  and  better 
characterisation tools and process control (e.g. PVD and CVD processes for coatings). 

For paints and coatings, the properties of traditional powdered ingredients such as fillers and 
extenders change when their size decreases; and the behaviour of particle surfaces begins to 
dominate.  Such  effects  include  ultraviolet  blocking,  anti-static  and  conductive  capabilities. 
Paints  and  coatings  industries  were  among  the  first  to  take  advantage  of  these  capabilities 
three to five years ago. Coatings incorporating nanoparticles are smoother, stronger, and more 
durable, with only small differences in cost. (More generally, nanomaterials are being widely 
incorporated  in  coatings,  to  obtain  results  ranging  from  scratch-resistant  and  self-cleaning 
surfaces to moisture-absorbing clothing.) 

Nanomaterials  presently  used  for  lubrication  include  nanotechnology-based  solid  lubricants, 
which reduce friction between moving parts and minimise wear, save maintenance costs and 
improve  overall  engine  performance  –  with  resulting  reductions  in  energy  consumption  and 
air pollution. An example is the use of new cooling fluids and ferrofluids. 

Iron-based nanomaterials injected into certain fluids can be used for suspension and braking 
systems, as their viscosisty can be changed instantaneously to suit conditions. 

Nanomaterials presently used for tyres include nanomaterials of inorganic clays and polymers 
to replace carbon black, leading to tyres that are environmentally friendly and wear resistant; 
New  nanocoatings  can  reduce  weight,  improve  pressure  retention  and  reduce  recycling  and 
incineration  costs.  In  the  past  few  years,  European  producers  of  elastomers  and  inorganic 
oxides have teamed to produce a green tyre, based on hydrocarbon elastomers reinforced with 
nanostructured silicon dioxide. 

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Looking  into  the  future,  nanotechnology  will  keep  penetrating  into  the  transport  sector, 
provided that it delivers clear advantages compared to competing solutions, which still offer 
room  for  improvements.  Coatings  and  surface  treatments  are  likely  to  continue  to  be  the 
fastest  growing  sectors  both  in  vehicle  parts,  and  in  tooling  and  production  equipment. 
Coating  technologies  are  more  mature,  can  benefit  from  developments  in  other  sectors  and 
can offer clear benefits in the short term (e.g. increased tooling lifetime). 

Eventually,  the  automotive  industry  should  benefit  from  nanotechnology  developments  in 
energy  applications.  In  principle,  almost  all  automotive  components  can  be  improved  by 
nanotechnology.  Furthermore,  the  automotive  industry  is  a  major  user  of  sensors  and 
components for new integrated and miniaturised systems. Micro-electro-mechanical systems 
(MEMS) have been a key driver in many of today’s advanced safety systems. 

4.3.6.  Nanomaterials for the Aeronautics Sector 

The main application domains for nanomaterials in the next generation of aerospace vehicles 
include:  airframe  and  components;  coatings  and  paints;  engines  and  engine  components; 
interior equipment and furnishing. 

Nanomaterials  presently  used  include:  nanopowders;  epoxy  matrixes  with  carbon  fibre 
reinforcements;  and  ceramics  (metallic  oxides,  nitrides  and  carbides)  for  coatings  –  e.g. 
zirconium  oxide  in  combination  with  yttrium  oxide  is  used  in  coatings  and  components  for 
gas turbines and jet engines. 

No  nanomaterials  are  as  yet  in  industrial  use  for  engines  and  engine  components,  although 
potential applications have been identified for organic matrix composites and ceramic matrix 
composites  in  linings,  paints,  sensors  and  actuators.  These  are  expected  to  result  in 
enhancements  of mechanical properties. Polymer conductors and ceramics are also likely to 
permit the modification of certain physical properties, for example to improve fire resistance. 
New tribological coverings are yet another possibility. 

4.3.7.  Nanomaterials for the Construction Sector 

Buildings  within  the  EU  account  for  42  %  of  the  total  final  energy  consumption  and  are 
responsible for about 35 % of all greenhouse emissions. Therefore, energy-efficient buildings 
will  be  crucial  for  environmentally  sustainable  development.  In  this  regard,  nanotechnology 
offers  several  pathways  for  significant  improvements  in  thermal  isolation  and  reductions  in 
greenhouse emissions. 

Increasing  the  strength  and  durability  of  materials  is  central  to  the  drive  to  reduce  the 
environmental  footprint  of  buildings,  by  making  more  efficient  use  of  resources.  This  is 
achieved  prior  to  the  construction  process,  by  reducing  pollution  during  the  production  of 
materials; and also in service, through an efficient use of energy due to advances in insulation. 
Two nanomaterials that stand out in their application to construction are silicon dioxide and 
titanium  dioxide.  Silicon  dioxide  is  the  most  common  nanomaterial  in  today’s  construction 
industry  –  in  terms  of  production  volume  per  year.  This  is  being  used  to  strengthen  and 
monitor concrete. The photocatalytic activity of titanium dioxide can be used to break down 
dirt  particles  when  exposed  to  sunlight.  Self-cleaning  windows  and  roof  tiles  have  already 
been brought to market. Titanium dioxide may also be used to convert the whole surface of 
buildings into relatively inefficient but cheap solar cells harvesting energy from sunlight. 

Carbon nanotubes (CNTs) may be used to strengthen and monitor concrete. Cost factors and 
the relatively small number of practical applications are preventing developments, at present. 
Nevertheless, the construction sector is expected to benefit indirectly from advances in other 
sectors where CNTs are of interest. 

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4.3.8.  Nanomaterials for the Textile Sector 

The  ETP  for  the  Future  of  Textiles  and  Clothing  has  developed  a  vision  for  the  very  large 
market in textiles, based on three trends:142 

–  Development of new speciality fibres and fibre composites (and environmentally friendly 

processes) for innovative textile products, to move from commodities to specialties; 

–  Development  of  new  textile  products  for  innovative  technical  applications  and  “smart” 

textiles and clothing, to allow new applications; 

–  Implementation  of  new  design  and  product  development  concepts,  integrated  quality  and 

life cycle management, to offer customisation for clothing and fashion. 

Nanotechnology can play a role in all three trends; there are two main possibilities: The first 
one is an enhancement of present functions and performance of textile materials. For example, 
fabrics  prepared  with  nanomaterial  fillers  or  using  innovative  finishing  treatments,  offer 
enhanced  strength  and  durability,  flame  resistance,  self  cleaning,  variable  chromatic 
behaviour,  light  protection,  hydrophilic  or  hydrophobic  properties  and  antistatic  features. 
These  materials  can  be  used  for  a  large  variety  of  applications,  including  sportswear, 
protective  clothing  and  packaging.  Products  with  some  of  these  features  are  already  finding 
their way on the market. The second, longer-term possibility is the development of innovative 
products,  in  particular  smart  or  functional  textiles  with  new  features  and  functions  –  e.g. 
energy  generation;  controlled  release  of  drugs  or  scents;  and  sensing  and  actuating 
capabilities. 

4.3.9.  Nanomaterials for the Cosmetics Sector 

Nanomaterials  like  titanium  dioxide  and  zinc  oxide  are  most  widespread,  and  are  highly 
effective as UV (ultraviolet) filters in sunscreens. Nanotechnology-based materials (so-called 
bio-composites)  in  toothpaste  promote  the  natural  tooth  repair  mechanism  of  saliva.  In  care 
products,  nanocapsules  protect  and  transport  active  ingredients  and  enhance  their  effect. 
Fullerenes have begun to be used in cosmetic products for this purpose. Research is underway 
on improving the physical properties (e.g. the transparency) of finished cosmetic products by 
using nanomaterials. 

Common active ingredients used in cosmetic formulations, such as vitamins or anti-oxidants, 
can  be  contained  in  nanospheres,  nanocapsules,  oleosomes  and  liposomes.  The  production 
techniques  involved,  such  as  coacervation  or  phase  separation,  are  important,  because  they 
can  improve  the  stability  of  the  cosmetic  formulation  and  the  active  ingredients  involved. 
Some  cosmetic  products  use  mineral-based  materials  and  their  performance  depends  on 
particle  size.  In  sunscreen  products,  mineral  nanoparticles  (titanium  dioxide  and  zinc  oxide 
with particle sizes of the order of 20 nm) are efficient UV filters. They transmit, reflect and 
scatter the visible part of the solar radiation, while absorbing strongly in the UV region.  

Fullerenes  (C60)  are  reported  to  be  used  in  a  number  of  cosmetic  products,  including  face 
creams.  Vesicular  systems,  including  liposomes,  have  been  incorporated  in  many  cosmetic 
formulations.  Liposomes  are  colloidal  particles,  typically  consisting  of  phospholipids  and 
cholesterol.  The  lipid  molecules  form  bi-layers  surrounding  an  aqueous  core.  Both  the  bi-
layer  and  the  core  can  be  used  to  entrap  and  deliver  ingredients  to  the  skin.  Most  studies 
describe a non-specific  targeting  effect, whereby vesicles allow  accumulation  of ingredients 
in the stratum corneum or other outer layers of the skin. It is unknown to what extent quantum 

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dots,  nanotubes  or  other  nanomaterials  have  found  use  in  marketed  cosmetic  products,  but 
patents for such products exist. 

4.3.10.  Nanomaterials for the Agriculture and Food Sector 

Nanotechnology has the potential, as yet unrealised, to revolutionise the agricultural and food 
industry,  with  new  tools  for  the  molecular  treatment  of  diseases,  rapid  disease  detection, 
enhancing  the  ability  of  plants  to  absorb  nutrients,  and  so  on.  Smart  sensors  and  smart 
delivery systems will help the agricultural industry combat viruses and other crop pathogens. 
In  the  near  future,  nanostructured  catalysts  will  be  available,  which  will  increase  the 
effectiveness of pesticides and herbicides, allowing lower doses to be used. Nanotechnology 
will also protect the environment indirectly through the use of alternative energy supplies, and 
filters or catalysts to reduce pollution and clean-up existing pollutants. 

Controlled Environment Agriculture (CEA) is a widely used method, which relies on modern 
technology for crop management. This is an advanced and intensive form of hydroponically-
based  agriculture.  Plants  are  grown  within  a  controlled  environment,  so  that  horticultural 
practices  can  be  optimised.  A  computerised  system  monitors  and  regulates  localised 
environments,  such  as  fields  of  crops.  CEA  technology,  as  it  exists  today,  provides  an 
excellent  platform  for  the  introduction  of  nanotechnology  to  agriculture.  With  many  of  the 
monitoring and control systems already in place, nanotechnology-based devices that provide 
“scouting” capabilities could significantly improve the grower’s ability to determine the best 
time of harvest for the crop, the vitality of the crop, and food safety issues, such as microbial 
or  chemical  contamination.  Nanobiotechnology-based  sensors  will  lead  to  equipment  of 
increased  sensitivity,  allowing  an  earlier  response  to  environmental  changes.  For  example, 
nanosensors using carbon nanotubes or nano-cantilevers are small enough to trap and measure 
individual  proteins;  and  nanomaterials  or  nanosurfaces  can  be  engineered  to  trigger  an 
electrical  or  chemical  signal  in  the  presence  of  contaminants  such  as  bacteria.  Ultimately, 
precision farming using smart sensors, will lead to an enhanced productivity in agriculture by 
providing accurate information, thus helping farmers to make better decisions. 

relevant 

in  nanomedicine  will  also  be 

Some  developments 
to  animal  diseases. 
Nanotechnology can also be used to clean ground water using, for example nanometre-scale 
diameter aluminium oxide nanofibres as a water purifier. Filters made from these fibres can 
remove  viruses,  bacteria  and  protozoan  cysts  from  water.  Other  examples  include  water 
purification techniques using specific nanofiltration technologies with holes of 100 nm in size. 
Some  companies  are  working  on  water  filtration  by  making  use  of  lanthanum  nanoparticles 
that absorb phosphates from aqueous environments. Applying these effectively,  for instance 
in  aquaculture  ponds,  removes  available  phosphates  and  as  a  result  prevents  the  growth  of 
algae. 

The impact of nanotechnology in the food industry  has  become  more apparent over the  last 
few  years,  with  applications  including  smart  packaging  to  optimise  product  shelf-life  and 
smart monitoring. Building on the concept of “on-demand” food, the idea of interactive food 
is to allow consumers to modify food depending on their own nutritional needs or tastes. The 
concept  is  that  nanocapsules  containing  flavour  or  colour  enhancers,  or  added  nutritional 
elements  such  as  vitamins,  would  remain  dormant  in  the  food  and  only  be  released  when 
triggered by the consumer. They are also activities related to enhancing the nutritional quality 
of food through selected additives, and improvements in the way in which the body digests 
and absorbs food. 

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4.4. 

Standardisation and Metrology 

4.4.1. 

Introduction 

Standardisation  (the  process  of  developing  and  agreeing  upon  technical  standards)  and 
metrology  (the  science  of  measurements  and  its  application)  are  two  separate  areas  with 
several overlapping aspects. 

Metrology  goes  beyond  standardisation,  as  it  investigates  and  develops  the  concepts  and 
approaches  that  can  make  measurement  results  traceable  and  comparable,  not  only 
independent of the time and of the place where the measurement was performed, but also – if 
possible  –  independent  of  the  measurement  method  that  was  used.  Respecting  the  basic 
concepts  of  metrology  makes  measurement  results  more  reliable  and  robust.  However,  in 
several new or complex measurement fields, such as in nanosciences and nanotechnologies, 
the  properties  and  the  materials  that  are  to  be  measured  are  often  not  sufficiently  well 
understood to be able to disconnect the measurement result from the method that was used to 
make  the  measurement  –  that  is,  the  measurement  results  are  method-dependent.  Thus 
metrology  relies  on  standardisation  in  the  development  and  improvement  of  internationally 
accepted and agreed measurement methods. 

Standardisation goes beyond metrology, since it not only deals with measurements, but also 
with  global  harmonisation  of  terminology,  products  and  services.  Currently,  standardisation 
for  nanotechnology  is  a  much  more  developed  area  than  that  of  metrology  specific  to 
nanotechnology.  This  will  continue  to  be  the  case  as  long  as  the  measurement  needs  of 
industry and innovators, consumers and regulators need to be met without the availability of 
an improved, in-depth understanding of some of the issues of measurement at the nanoscale. 

In  terms  of  research  and  innovation,  the  following  sub-sections  will  show  what  has  been 
achieved so far  in  both  standardisation and  metrology for nanotechnology; which initiatives 
have been launched; and what plans there are for the next few years. 

4.4.2.  Research, Innovation and Standardisation,  
Norms  or  standards  are  an  important  driver  of  innovation,143  as  they  provide  legal  certainty 
for  innovative  companies,  help  in  creating  large-scale  markets  and  in  building  confidence 
among  consumers.  They  influence  the  innovation  process  through  “path  dependency”;  in 
other  words,  when  technical  specifications  are  defined,  the  options  for  future  technological 
developments are by definition narrowed, since less suitable alternatives are ruled out through 
a combination of technical and market choices. The Communication on the contribution from 
standardisation  to  innovation,144  adopted  in  2008,  is  a  key  Commission  document  on 
standardisation and innovation. 

The  Commission  services  closely  monitor  follow-up  activities  outlined  here,  including  the 
acceleration  of  standard-setting  and  the  relationship  between  IPR  and  standards,  since  these 
are of relevance to access to standardisation. Lessons are also learnt from the standardisation 
projects  within  the  Europe  INNOVA  initiative  (see  section  4.2  above).  The  aim  of  the 
Standards  Networks145 in  Europe  INNOVA  is  to  demonstrate in practice how standards can 
enhance  innovation  in  Europe.  These  will  also  be  an  issue  in  some  of  the  new  platforms  in 

http://ec.europa.eu/enterprise/policies/innovation/policy/standards/index_en.htm 
COM(2008)133; 

143 
144 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0133:FIN:en:PDF 
145 

http://standards.eu-innova.org/ 

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Phase 2 of Europe INNOVA. In the particular field of standardisation in ICT, a White Paper 
is being prepared and a workshop146 has been organised. 

The Council Conclusions on standardisation and innovation (25 September 2008) confirmed 
“the  essential  contribution  which  standardisation  can  make  towards  developing  innovation 
and competitiveness, by facilitating access to markets, enabling interoperability between new 
and  existing  products,  services  and  processes,  enhancing  protection  of  users,  giving 
consumers confidence in innovations and disseminating research results”. In order to address 
this  challenge,  the  CEN  and  CENELEC  Technical  Boards  agreed  in  October  2008  on  the 
creation  of  a  joint  strategic  Working  Group  to  address  Standardisation,  Innovation  and 
Research,  STAIR  for  short.147  The  STAIR  Group  had  a  first  meeting  on  27  January  2009. 
CEN-CENELEC STAIR will prepare strategic advice to the two Technical Boards in order to 
reach an integrated approach between research and innovation and standardisation. 

To  meet  this  objective,  the  STAIR  Group  will  consider  the  Commission’s  policies  on 
innovation  and  research,  and  how  CEN  and  CENELEC  can  contribute  as  effectively  as 
possible to their implementation. The STAIR Group will address the “standards gap” that was 
identified  by  the  COPRAS  project  of  FP6.  This  refers  to  the  fact  that,  after  an  EU-funded 
research  project  closes,  it  has  no  further  resources  to  submit  its  results  to  the  standards 
process.  The  Group  will  therefore  review  the  funding  mechanisms  of  standardisation  in 
relation to innovation, with a view to identifying solutions to fill the gaps in projects between 
the  R&D  and  standardisation  phases.  It  will  also  review  the  existing  CEN-CENELEC 
documentation on R&D and standardisation and develop new guidance material reflecting the 
integrated  approach.  Guidance  for  researchers  to  “show  the  way”  to  standardisation  will  be 
developed. An important challenge for the standards bodies is to make stakeholders aware of 
the benefits that standardisation can bring to them. National seminars on standardisation and 
innovation are one  means  to  this end. The  STAIR  Group will support  CEN and  CENELEC 
Members with an interest in such national seminars, by identifying and exchanging “success 
stories”, where standardisation was instrumental in supporting innovation. In addition to these 
national  seminars,  STAIR  will  also  seek 
to  organise  a  European  conference  on 
“standardisation  and  innovation”  targeting  research  and  other  relevant  organisations.  The 
CEN-CENELEC  STAIR  has  been  tasked  to  address  all  these  challenges  (the  integrated 
approach, the production of guidelines, the organisation of seminars and conferences, and so 
on) in the short to medium term, and should therefore complete its current work plan by the 
end of 2010. 

4.4.3.  Nanotechnology standards: New achievements and developments 

Between  2007  and  2009  the  Technical  Committees  CEN/TC 352  and  ISO/TC 229,  both 
initiated in 2005, became fully operational. Several EU national bodies contribute to the ISO 
work  (thirteen  EU  countries  are  Participating  Members,  and  three  more  are  Observing 
Members).  Industry  associations  as  well  as  consumer  organisations  have  become  liaison 
members.  The  Commission’s  Joint  Research  Centre  is  very  actively  involved  as  a  liaison 
member in both Technical Committees. 

To  avoid  duplication,  and  because  of  the  global  relevance  of  harmonised  standards,  EU 
members have expressed their preference for the development of standards at the ISO level. 
For  topics  of  mutual  interest  to  both  ISO  and  CEN,  work  is  carried  out  under  the  Vienna 
Agreement, with an ISO or CEN lead. The contribution to the development of ISO standards 

146 
147 

http://ec.europa.eu/enterprise/ict/policy/standards/ws08ipr_en.htm 
http://www.cen.eu/cenorm/workarea/advisory+bodies/stair/index.asp 

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via  CEN  is,  incidentally,  one  way  of  involving  in  the  nanotechnologies  standardisation 
process those EU countries that do not have the means to participate at ISO level. 
Forty different ISO documents are currently being developed in ISO/TC 229148 in the fields of 
terminology  and  nomenclature  (JWG1);  measurement  and  characterisation  (JWG2);  health, 
safety  and  environmental  aspects  of  nanotechnologies  (WG3);  and  materials  specifications 
(WG4). The following available outputs are noted here: 

–  ISO/TR  12885:2008:  Health  and  safety  practices  in  occupational  settings  relevant  to 

nanotechnologies 

–  ISO/TS  27687:2008:  Terminology  and  definitions  for  nano-objects  –  Nanoparticle, 

nanofibre and nanoplate 

The following documents are in the final approval stages and will be available soon: 

–  ISO  10808:  Characterisation  of  nanoparticles  in  inhalation  exposure  chambers  for 

inhalation toxicity testing 

–  ISO  TS  11251:  Characterisation  of  single-wall  carbon  nanotubes  using  evolved  gas 

analysis-gas chromatograph mass spectrometry 

–  ISO  TS  10868:  Nanotubes  –  Characterisation  of  single-wall  carbon  nanotubes  using 

ultraviolet, visible and near infrared spectroscopy 

–  ISO TR 80004-1: Terminology – Framework for core concepts 

–  ISO TS 80004-4: Terminology and definitions for carbon nano-objects 

–  ISO  29701:  Nanotechnologies  –  Endotoxin  test  on  nanomaterial  samples  for  in  vitro 

systems – Limulus amebocyte lysate (LAL) test 

Finally,  the  following  is  a  selection  of  running  work  items  with  a  particular  potential  to 
contribute to closing knowledge gaps in the HSE area: 

–  ISO  12025:  General  Framework  for  Determining  Nanoparticle  Content  in  Nanomaterials 

by Generation of Aerosols 

–  ISO TR 13329: Preparation of Material Safety Data Sheet (MSDS) for nanomaterials 

–  ISO  TS  14101:  Surface  characterisation  of  gold  nanoparticles  for  nanomaterial  specific 

toxicity screening: FT-IR method 

–  ISO TS 12901-1: Guidance on safe handling and disposal of manufactured nanomaterials 

–  ISO  TR  13014:  Guidance  on  physicochemical  characterisation  of  engineered  nanoscale 

materials for toxicological assessment 

–  ISO TS 13278: Carbon nanotubes – Determination of metal impurities in carbon nanotubes 

(CNTs) using inductively coupled plasma-mass spectroscopy (ICP-MS) 

–  ISO  TS  12901-2:  Guidelines  for  occupational  risk  management  applied  to  engineered 

nanomaterials based on a control banding approach 

Based on criteria of intended document status and relevance for Europe, CEN/TC 352 makes 
a selection from the large number of ISO/TC 229 work items, and adds these items in its own 
work programme. The work programme of CEN/TC 352 also includes a number of items led 
by CEN, but these are currently limited to a “Guide to nanoparticle measurement methods and 

148 

http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983 

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their  limitations”;  a  “Guide  to  methods  for  nanotribology  measurements”;  and  a  “Guide  to 
labelling of manufactured nanoparticles and products containing manufactured nanoparticles”. 

It should be noted that ISO/TC 229 and CEN/TC 352 have been initiated in order to fill gaps 
left  by  a  wide  array  of  other  ISO  and  CEN  TCs,  which  have  been  dealing  with 
nanotechnology-related standards for many years, in particular, but not only, the measurement 
and  characterisation  of  particles  and  materials  microstructures.  Among  the  more  than  thirty 
current  liaison  members  of  ISO/TC 229,  are  ISO/TC  24  (particle  characterisation);  ISO/TC 
146 (air quality); ISO/TC 201 (surface chemical analysis); ISO/TC 202 (microbeam analysis); 
ISO/TC  209  (clean  rooms  and  associated  environments);  ISO/REMCO  (ISO  Reference 
Materials  Committee);  and  also  the  OECD,  the  IUPAC  and  the  IEC.  These  TCs  and  other 
organisations  have  an  interest  in  the  development  of  nanotechnology-related  standards,  and 
meet twice a year in the Nanotechnologies Liaisons Coordination Group (NLCG), which was 
initiated  after  the  international  workshop  of  ISO,  IEC,  NIST  and  OECD  on  documentary 
standards  for  measurement  and  characterisation  for  nanotechnologies  (Gaithersburg, 
Maryland, USA, 26-28 February 2008). The NLCG will “provide a forum to help coordinate 
and harmonise the work of relevant technical committees and other organisations in the field 
of nanotechnologies and to identify crosscutting gaps and opportunities and ways to address 
these.” 

Among  all  ISO  standardisation  committees,  the  ISO/TC  24/SC  4  (particle  characterisation) 
today has the largest number of nanotechnology-related standards to offer. The work of this 
committee is followed by the JRC, which also provides the liaison between ISO/TC 24/SC 4 
and ISO/REMCO. The committee’s work programme used to focus on the sizing of particles, 
but  since  2009  it  also  covers  other  nanotechnology-relevant  properties  such  as  dispersion 
stability and zeta-potential measurements. 

4.4.4.  Plans  for  future  standardisation  activities:  The  CEN  report  to  the  Commission’s 

programming mandate and the Commission’s response 

In May 2008, the CEN/TC 352 Mandate Report Group submitted a report to the Commission 
on its Mandate addressed to CEN, CENELEC and ETSI for the development of a programme 
of standards to take into account the specific properties of nanotechnology and nanomaterials 
(M/409).  This  report  is  based  on  an  extensive  review  of  CEN  and  CENELEC  Technical 
Committees  (TCs),  European  Technology  Platforms  (ETPs)  and  organisations  and 
associations  with  a  possible  interest  in  nanotechnology.  It  was  undertaken  in  order  to 
determine the level of interest or activity by these groups in current or future standardisation 
related to nanotechnology. Included in this survey were specific questions about existing and 
future standards that relate to nanotechnology, which may need to be revised or prepared to 
take nanotechnology into account. 

This work was also linked to the identification of standardisation needs performed within the 
EU-funded  Nanostrand  project.  Moreover,  EU-funded  projects  in  nanotechnology  were 
recently  scanned  to  identify  any  research  activity  relevant  to  standardisation.  Relevant 
projects were grouped in the following clusters: 

–  Bio applications excluding bio-chips and diagnostics 

–  Bio-chips, bio-sensors and diagnostics 

–  Nanomanufacturing and nanomaterials 

–  Self assembly, templating and nanopatterning 

–  Tools for nanotechnology 

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–  Toxicology and safety 

EU-funded  projects  in  these  areas  are  encouraged  to  develop  and  implement  active 
standardisation policies. Other projects, large ones in particular, are including standardisation 
efforts in their work plans. The picture presented is patchy. A large proportion of the groups 
consulted  either  did  not  respond,  or  declared  little  or  no  current  interest  or  activity.  On  the 
other  hand,  some  groups  provided  very  comprehensive  replies,  indicating  their  interest  or 
activity, now or in the future. All CEN and CENELEC TCs with responsibility for standards 
harmonised  to  New  Approach  Directives  were  consulted;  and,  other  than  two  standards 
harmonised  to  the  medical  devices  Directives,  there  is  no  positive  information  that  any 
harmonised  standard  currently  needs  review  or  revision  with  respect  to  nanotechnology 
developments.  In  view  of  the  many  TCs  that  did  not  respond,  however,  it  is  possible  that  a 
complete  picture  has  not  been  obtained.  A  lack  of  certainty  or  an  understanding  of  the  role 
that  standards  deliverables  can  play  in  supporting  the  existing  and  future  regulatory 
framework could have affected the survey results. 

The  report  on  the  mandate  provides  a  list  of  proposed  standards  projects  under  the  three 
general categories of (i) health, worker and environmental safety; (ii) the Lisbon agenda; and 
(iii) the societal agenda. The standards deliverables that are likely to be needed are described 
in this report. These will include primarily CEN Technical Specifications (TSs – normative) 
and Technical Reports (TRs – informative), although European Norms (ENs – normative and 
to be implemented by all EU members) will be appropriate in some circumstances. There may 
also be a role for fast-track deliverables such as Publicly Available Specifications (PASs) and 
CEN Workshop Agreements (CWAs). 

Whichever  way  the  work  is  developed,  there  should  be  close  cooperation  between 
CEN/CENELEC  and  ISO/IEC,  and  there  is  scope  for  Vienna  and  Dresden  Agreements 
deliverables  with  both  ISO/IEC  and  CEN/CENELEC  leads,  in  addition  to  those  projects 
which have already been initiated in collaboration between the nanotechnology TCs of CEN 
and  ISO  (CEN/TC 352  and  ISO/TC 229).  Indeed,  the  standardisation  programme  is 
potentially so large that all available standardisation resources should be embraced. There is 
likely to be a considerable level of as yet untapped technical expertise in Europe that can be 
used  in  the  area  of  standardisation.  The  level  of  participation  in  standards  activity  in 
CEN/TC 352 is currently not fully representative of known stakeholders, comprising mostly 
national  standards  bodies,  national  metrology  institutes,  and  a  few  universities  and  research 
establishments. The European standards bodies make the following recommendations: 

(1) 

(2) 

(3) 

A  group  should  be  established  to  focus  on  the  opportunities  and  needs  for 
nanotechnology  standardisation  that  can  arise,  for  example,  within  ETPs  and  EU-
funded  projects.  Membership  of  such  a  group  should  be  representative  of  relevant 
stakeholders, including TCs and other structures within CEN, CENELEC and ETSI. 

The Commission should require that funded projects consider, where applicable, how 
their  project  work  can  be  translated  into  appropriate  standards.  The  outcome  of  this 
consideration should be a project deliverable. 

A  programme  of  standardisation,  as  described  in  the  report,  should  be  initiated,  by 
means of a standardisation mandate to CEN, CENELEC and ETSI, to encourage the 
development of nanotechnology-specific standards in Europe, and the participation of 
European stakeholders in the European standardisation process. 

(4) 

The  Commission  should  provide  clear  guidance  as  to  what  standards  projects  are 
needed to support existing or future legislation. 

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(5) 

(6) 

Additional  incentives  should  be  provided  for  stakeholders  to  participate  in  the 
nanotechnology  standardisation  process,  for  instance  through  the  provision  of 
straightforward  means  of  funding  participation  in  standards  committee  meetings,  in 
particular  those  dealing  with,  and  proposing,  New  Work  Items  corresponding  to  the 
list of required standards listed in this report. 

Because  of  the  current  early  status  of  standardisation  in  nanotechnology,  it  is 
recommended  that  the  Commission  give  a  further  programming  mandate  in  four  to 
seven  years’  time.  This  programming  mandate  should  include  funding  for  expert 
participants to provide input to the report. 

The Commission is currently finalising its response to these recommendations. At the time of 
writing, it can be concluded that there is an agreement to enhance the links between CEN (e.g. 
TC 352)  and  relevant  EU-funded  projects,  to  ensure  that  the  pre-and  co-normative  research 
work is finding its way into standards and technical specifications. 

With regard to the preparation of specific standardisation mandates, a preliminary conclusion 
is that the activities of CEN (e.g. TC 352) should focus on producing documentary standards 
in  the  fields  of  nomenclature  (definitions  of  nanotechnology-specific  terms,  materials 
nomenclature  based  on  nanomaterial  structures);  characterisation  (general  guidance  on  the 
relevance  and  limitations  of  measuring  specific  properties,  new  and  improved  standard 
measurement  methods);  exposure  (sampling,  new  and  improved  standard  measurement 
methods,  exposure  models  and  mitigation  approaches  in  the  areas  of  safety  related  to  the 
workplace,  consumer  products  and  environment);  and  simulation  methodologies  (simulation 
of possible workplace, consumer and environment exposure). The simulation of exposure in 
particular was not explicitly included in the report, but is already part of the ISO/TC 229 work 
programme;  recent  research  activities  and  publications  led  to  approaches  that  should  be 
particularly helpful in assessing various exposures. 

Turning  to  the  proposed  standardisation  work  on  testing  methodologies  for  toxicology  and 
ecotoxicology,  a  preliminarily  conclusion  is  to  leave  the  pre-normative  and  co-normative 
work  to  the  OECD-WPMN,  given  its  current  and  planned  activities  in  the  area  (within  its 
sponsorship  programme).  It  is  necessary  to  integrate  the  standardisation  outputs  into  the 
OECD-WPMN  activities  and  ensure  a  good  synergy  between  all  relevant  efforts.  This  is 
considered  to  be  ensured  by  the  Vienna  Agreement  between  CEN  and  ISO,  and  the 
collaboration  between  CEN/TC 352  and  ISO/TC 229,  as  well  as  by  the  links  established 
between ISO/TC 229 and the OECD-WPMN. 

4.4.5.  Metrology,  pre-  and  co-normative  research,  and  tools  for  measurement  quality 

assurance 

Measurement  methods  with  nanometre-resolution  and  methods  applicable  to  the  assessment 
of  nanoparticles  and  nanostructured  materials  are  often  still  under  development.  The  area  is 
research-intensive,  because  of  the  many  ambiguities  in  nanomaterials  work.  In  the  specific 
case  of  nanoparticles,  it  is,  for  example,  not  yet  generally  realised  that  particle  size 
distribution is not a fundamental property of the material being studied, but a temporary state 
of  dynamic  equilibrium  between  dispersion  and  agglomeration  in  suspensions  or  aerosols. 
Such  differences  between  perception  and  reality  present  tremendous  challenges  in 
nanotechnology.  These  can  only  be  successfully  tackled  with  the  appropriate  metrology 
concepts, and by developing workable reference systems. 

As mentioned, there is a need for clarity in the identification of measurands related to several 
materials  properties.  There  is  also  a  need  for  new  measuring  instruments  and  techniques, 
which, once developed, will need validation and verification. This is the topic of pre- and co-

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normative  research,  which  is  performed  in  industrial  research  projects  (such  as  FP7)  or  in 
collaborative  organisations,  such  as  VAMAS  (the  Versailles  project  on  Advanced  Materials 
and  Standards,  established  in  1982  as  one  of  18  cooperative  projects  intended  to  stimulate 
trade in new technologies using advanced materials, through pre-standardisation research).149 

In  VAMAS,  work  is  undertaken  in  Technical  Working  Areas  (TWAs),  two  of  which  are 
directly relevant to nanotechnologies – TWA 29, nanomechanics applied to SPM, and TWA 
33, polymer nanocomposites. These have now been complemented by the establishment of a 
new  TWA  on  the  characterisation  of  nanoparticle  populations,  with  projects  on  airborne 
nanoparticles,  on  multiwall  carbon  nanotubes,  and  on  nanostructured  titanium  dioxide. 
VAMAS can provide the outcomes of its pre-normative and co-normative research directly to 
the  ISO  standardisation  process.  To  reflect  the  globalisation  of  materials  research,  the 
VAMAS membership is now wider, with the founding members – Canada, France, Germany, 
Italy,  Japan,  UK,  USA  and  the  European  Commission  –  joined  by  Korea,  Taiwan,  South 
Africa, Mexico, Australia, Brazil and India between 2007 and 2009. 

The  relevance  of  pre-  and  co-normative  research  for  measurement  standards  has  been 
emphasised  by  the  adoption  of  a  metrological  check-list  in  ISO/TC 229/JWG  2.150  This 
document  was  developed  at  the  JRC  and  is  beginning  to  provide  more  structure  to  the 
TC 229/JWG  2  work  programme.  The  development  and  dissemination  of  proper  metrology 
concepts in the nanotechnology arena is also the aim of the recently started EU-funded project 
Co-Nanomet,151  with  partners  from  eight  EU  countries  as  well  as  the  JRC.  A  first  Co-
Nanomet  workshop  on  the  issue  of  standards  for  nanotechnologies  was  included  in  the 
EuroNanoForum programme (see section 1.5 above). The Co-Nanomet strategy document for 
European nanometrology is under development, with a stakeholder workshop planned for 19-
20 November 2009, in Braunschweig. 

An  important  metrology  activity  relevant  to  nanotechnology  also  launched  in  2008,  as  the 
European Association of National Metrology Institutes (EURAMET), has become responsible 
for the development and execution of the European Metrology Research Programme (EMRP), 
an Article 169 initiative.152 Within the current activities of national metrology institutes, much 
research  is  being  done  on  nanoscale  measurements,  which  is  of  direct  relevance  to 
standardisation  in  nanotechnologies.  It  is  important  to  ensure  that  work  in  EURAMET, 
including EMRP, is properly exploited in future European standardisation work. 

With  respect  to  the  tools  required  to  advance  research  and  understanding  in  the 
nanotechnology field, the issue of suitable reference materials was already mentioned.153 The 
development of reference materials, and their role in the development of new test protocols 
for  the  assessment  of  potential  hazards,  was  a  subject  in  the  NanoImpactNet  Workshop  on 
standardisation of materials and protocols (Dublin, 20 June 2008). This activity on reference 
materials  is  also  related  to  the  work  of  OECD-WPMN  (see  sub-section  6.6.1),  and  to  the 
development of the measurement infrastructure required for implementation of regulation. 

149 
150 

151 
152 

153 

http://www.vamas.org/ 
ISO/TC 229/JWG2_N095rev1,  “Metrological  check-list  for  use  in  the  preparation  and  evaluation  of 
ISO NWIPs and ISO WDs” 
http://www.co-nanomet.eu 
Article 169 of the EC Treaty enables the Community to participate in research programmes undertaken 
jointly by several Member States, including participation in the structures created for the execution of 
national programmes. 
Section 1.3 and JRC, http://irmm.jrc.ec.europa.eu 

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Patents 

4.5. 
The following conclusions on nanotechnology patents can be drawn:154 (i) inventive activities 
in nanotechnology have been gathering momentum since the late 1990s; (ii) nanotechnology 
is a set of technologies on the nanometre scale, rather than a single technological field; (iii) 
higher education and government sectors are important knowledge sources; (iv) science is the 
driving  force  of  nanotechnology;  (v)  the  number  of  forward  citations  to  nanotechnology 
patent  applications  suggests  their  high  technological  and  economic  values;  (vi)  recent 
progress in patent databases opens a way to analyse the nature of nanotechnology; (vii) two 
kinds of nanotechnologies coexist, “top-down” and “bottom-up”, and it will take some time 
until bottom-up nanotechnologies have social and economic impacts. 
The  recently  launched  FP7  project  Nano2Market155  is  expected  to  provide  guidelines  for 
technology  transfer  in  nanotechnology  developments.  The  project  will  first  construct  value 
chains of the transfer of each technology through analysis of specific applications, with regard 
to  development  costs,  market  time,  complexity  of  licensing,  and  so  on.  Eventually  it  will 
develop  and  disseminate  business  models  and  efficient  rules  for  technology  transfer,  with 
special attention to research institutions and SMEs. 

4.6. 

OECD Working Party on Nanotechnology (WPN) 

At the international level, innovation is addressed by the OECD Committee on Scientific and 
Technological  Policy  (CSTP).  Under  the  CSTP,  a  Working  Party  on  Nanotechnology 
(WPN)156  was  established  in  March  2007  to  advise  on  emerging  policy  issues  of  science, 
technology  and  innovation  related  to  the  responsible  development  of  nanotechnology.  This 
work,  together  with  the  activities  of  the  OECD  Working  Party  on  Manufactured 
Nanomaterials  (WPMN),157  is  seen  as  the  basic  platform  to  ensure  that  a  balance  is  being 
achieved between innovation and capitalising on benefits on the one hand, and a proper risk 
analysis of nanomaterials on the other hand. 

In the period 2007-2008, work on six projects was carried out: 

Project A – Indicators and statistics: Reviewing available indicators and statistical information 
on nanotechnology and drafting a framework for the future collection of such data. There is 
still  a  clear  lack  of  internationally  comparable  and  validated  indicators  and  statistics  to 
monitor  nanotechnology  developments  for  policy  needs.158  Data  on  research  spending, 
publications  and patents have been collected. These show the significant lag of applications 
(as  shown  by  patents)  emerging  from  scientific  research  in  the  case  of  nanotechnology;  the 
predominance of the US in patents (even though publications from the EU are comparable in 
number to those of the US); the current dominance in terms of applications of nanomaterials 
and  nanoelectronics,  followed  by  nanobiotechnology;  and  the  rapid  emergence  of  new 
players. 

154 

155 
156 

157 

158 

More  detailed  information  can  be  found  in  the  OECD-WPN  publication  Capturing  nanotechnology’s 
current  state  of  development  via  analysis  of  patents,  http://www.oecd.org/dataoecd/6/9/38780655.pdf, 
and the associated presentation, http://www.oecd.org/dataoecd/25/39/40050927.pdf 
reference not available at the time of writing 
http://www.oecd.org/document/36/0,3343,en_2649_34269_38829732_1_1_1_1,00.html 
http://www.oecd.org/document/30/0,3343,en_2649_34269_40047134_1_1_1_1,00.html 
The  OECD  Working  Party  on  Manufactured  Nanomaterials  (WPMN)  was  established  in  September 
2006,  and  is  looking  at  international  co-operation  in  health  and  environmental  safety  aspects  of 
manufactured nanomaterials. 
Report “Nanotechnology: An Overview Based on Indicators and Statistics” 

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Project B – Companies and the business environment: Complements the statistical work with 
a set of company case studies across different application areas and countries. It analyses the 
impacts  and  business  environment  of  nanotechnology  and  the  challenges  for  business  in 
developing,  adopting  and  commercialising  nanotechnology.159  The  main  challenges,  apart 
from research issues, are safety issues (including the public perception of safety); difficulties 
in  production  (high  processing  costs);  and  a  shortage  of  appropriately  qualified  human 
resources. 

Project  C  –  International  scientific  co-operation:  This  project  collected  information  on 
research facilities,  networks and portals; links  to  respective  websites  are  given  on  the  WPN 
website. 

Project  D  –  Outreach  and  public  engagement:  Promoting  the  exchange  of  experience  in 
outreach and public engagement through questionnaires and country case studies. This project 
surveyed  challenges  and  practices  in  public  engagement,  outreach  and  communication  (15 
countries  and  the  Commission  contributed).  Furthermore,  a  conference  and  workshop  on 
public engagement were organised in Delft on 30-31 October 2008. 

Project  E  –  Policy  dialogue:  Reviewing  national  policy  approaches  to  the  responsible 
development of nanotechnology.160 A questionnaire collected information on nanotechnology 
policies from OECD Member Countries and the European Commission. 

Project  F  –  Global  challenges  (water):  In  the  first  instance,  this  project  focused  on  the 
contribution of nanotechnology to the purification of water and the barriers that will need to 
be  addressed,161  since  this  is  a  key  global  challenge,  especially  for  developing  countries.  It 
prepared  a  report  entitled  “Global  Challenges:  Water  and  Nanotechnology”,  outlining 
technologies  for  purification  and  management,  which  include  membrane  technologies  and 
catalysts. The application of nanotechnology to water is in fact growing more rapidly than the 
two wider sectors (nanotechnology and water) separately. 

A  new  work  programme  for  the  period  2009-2010  has  been  agreed,  building  on  the  work 
already carried out and aiming to support the development of policy. The six project areas are: 

(1) 

Statistical framework for nanotechnology; 

(2)  Monitoring and benchmarking nanotechnology developments; 

(3) 

(4) 

(5) 

(6) 

Addressing challenges in the business environment specific to nanotechnology; 

Fostering nanotechnology to address global challenges; 

Fostering international scientific co-operation in nanotechnology; and 

Policy roundtables on key policy issues related to nanotechnology. 

In  the  context  of  addressing  global  challenges,  a  conference  on  potential  environmental 
benefits  was  organised  jointly  with  OECD-WPMN  (the  OECD  Working  Party  on 
Manufactured Nanomaterials), with Commission and US funding. The “OECD Conference on 
Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-led Growth”, 
which  took  place  in  Paris  on  15-17  July  2009,162  covered  both  the  opportunities  and  the 

159 
160 
161 
162 

Report “Nanotechnology: Impacts on Companies, Business Environments and Policy” 
Report “Policy Dialogue – Progress Report and Questionnaire Findings” 
Report “Global Challenges: Water” 
OECD Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-
Led Growth, a joint event of OECD-WPN and OECD-WPMN 

see http://www.oecd.org/document/40/0,3343,en_2649_37015404_42323688_1_1_1_1,00.html 

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challenges of the use of nanotechnologies for potential environmental benefit. It is seen as a 
first milestone in collecting the information and developing the tools, which will help to strike 
this  balance  at  the  international  level  and  avoid  eventual  trade  difficulties.  The  conference 
sought  to  learn  from  international  expertise  and  identify  ways  in  which  policies  with  the 
potential  to  enhance  both  short-term  and  long-term  economic  growth  can  be  pursued.  This 
provided an opportunity for governments, academia and industry to consider the state-of-the-
art of nanotechnologies, their potential to bring environmental benefits, and, at the same time, 
concerns  regarding  human  health  and  environmental  safety.  In  particular,  the  conference 
addressed sustainability and life cycle aspects in a variety of sectors in which nanotechnology 
has  the  potential  to  give  rise  to  environmental  benefits.  Thus,  the  conference  explored  the 
environmental  profiles  of  emerging  nanoscale  innovation  with  the  goal  of  encouraging 
development  of  technologies  that  can  result  in  environmental  gain  while  addressing 
unintended  consequences.  The  following  key  areas  for  case  studies  were  included  in  this 
event:  energy  generation,  storage  and  conservation;  catalysis;  cleaner  production;  water 
treatment and purification; water and soil remediation; novel environmental sensor techniques 
using nanotechnologies and monitoring devices measuring nanomaterials; and solutions based 
on sustainable chemistry, including synthesis and processing of chemicals. 

A  policy  roundtable  on  “International  Scientific  Co-operation  in  Nanotechnology”  was 
organised in Braga on 22-23 June 2009, with a further roundtable on “Risk Governance” in 
Vienna on 25 September 2009. The OECD will publish conclusions from these in due course. 

5. 

SOCIETAL DIMENSION 

Societal  acceptance  is  a  key  aspect  of  the  development  of  nanotechnologies.  The 
Commission’s role as a policy making body is to take account of people’s expectations and 
concerns.  Not  only  should  nanotechnologies  be  applied  safely  and  produce  results  in  the 
shape  of  useful  products  and  services,  but  there  should  also  be  public  consensus  on  their 
overall impact. Their expected benefits, as well as potential risks and any required measures, 
must be fully and accurately presented, and public debate must be encouraged, to help people 
form an independent view. An effective dialogue with all stakeholders should be in place, so 
as to steer developments on a path that avoids negative societal impacts. Different actions are 
undertaken in order to pursue this overall objective. 

5.1. 

Code of Conduct for responsible nanosciences and nanotechnologies research 

In  February  2008  the  Commission  adopted  a  recommendation  for  a  “Code  of  Conduct  for 
responsible nanosciences and nanotechnologies research”.163 The Code promotes responsible 
research in nanosciences and nanotechnologies, in line with the objectives of the Action Plan. 
It  contains  a  series  of  principles  and  guidelines  that  Member  States,  and  ultimately  all 
stakeholders in the field of research, are invited to adopt and promote. Council Conclusions 
on the recommendation were adopted in September 2008. 

The Code of Conduct is voluntary and complementary to existing regulations. It does not limit 
or  otherwise  affect  the  right  of  Member  States  to  grant  a  wider  measure  of  protection  with 
regard  to  nanosciences  and  nanotechnologies  research.  The  Code  will  be  monitored  and 
revised  every  two  years  by  the  Commission  in  order  to  take  into  account  worldwide 
developments in nanotechnology and their integration in European society. 

and http://www.oecd.org/dataoecd/6/1/43284399.pdf 
163 

Commission  Recommendation  on  a  Code  of  Conduct 
nanotechnologies research, C(2008)424; 

for  responsible  nanosciences  and 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:116:0046:0052:EN:PDF 

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A  first  international  conference  on  the  Recommendation  of  the  European  Commission  on  a 
code of conduct for responsible nanosciences and nanotechnologies research was held on 7-8 
May 2008. 

Under  the  2009  Work  Programme  for  Science  in  Society,  a  call  was  launched  for  the 
coordination of projects which will address the European Commission’s recommendation on a 
code of conduct in Europe and beyond. 

In  addition  to  the  Commission’s  Code,  other  codes  have  been  developed,  such  as  the 
chemicals  industry’s  “Responsible  Care  Global  Charter  2006”;164  the  Responsible  Nano 
Code165  developed  by  the  Royal  Society  with  other  partners;  and  the  Nano  Risk 
Framework,166 developed by DuPont and the Environmental Defence Fund. 

5.2. 

Ethical issues 

The European Union has started the process of developing ethical standards to guide decisions 
in nanotechnology fields. In doing so, it has taken into account the principle of respect for the 
rights  of  individuals,  respect  for  multiculturalism,  dialogue  and  tolerance.  These  standards 
inform the ethical evaluation of new technologies and provide the necessary criteria. 
5.2.1.  Ethical issues in the 7th Framework Programme 

Research  activities  supported  by  FP7  must  respect  fundamental  ethical  principles,  including 
those reflected in the Charter of Fundamental Rights of the European Union. The opinions of 
the European Group on Ethics in Science and New Technologies are taken into account and 
this will continue to be the case. Research activities should also take into account the Protocol 
on  the  Protection  and  Welfare  of  Animals  and  reduce  the  use  of  animals  in  research  and 
testing, with the ultimate view of replacing it altogether.167 

As was the case in FP6, potential ethical issues are examined for all R&D projects considered 
under FP7, with ethical reviews carried out where appropriate. These reviews are conducted 
by dedicated panels of specialist independent evaluators, and are separate from the standard 
proposal  evaluations.  A  sizeable  proportion  of  nanotechnology  proposals  considered  for 
funding  (from  the  NMP  and  Health  themes)  have  been  subjected  to  such  ethical  reviews. 
Although the ethical issues raised by such projects were not in fact specific to nanotechnology 
(they involved animal testing, clinical trials and other tests on humans, and research involving 
human genetic material), it appears that proposers have in general demonstrated an awareness 
of  the  Commission’s  Code  of  Conduct  for  responsible  nanotechnology  research.  Experts 
involved in ethical reviews have also recognised the applicability of the Code of Conduct. 

To  support  work  on  ethical,  legal  and  societal  aspects  of  nanomedicine,  the  Commission 
funded the Nanomed Round Table,168 a support action that started in 2009, to support decision 
making in the area of nanomedicine, with regard to ethics, regulation and societal acceptance. 
Very  promising  as  it  is,  nanomedicine  may  add  new  dimensions  to  ethical,  social  and 
economic issues. It is therefore of primary importance to understand the possible impacts of 
nanomedicine  in  advance.  It  is  also  important  to  provide  all  stakeholders  with  a  well-
organised forum to express their needs  and  requirements, in particular those of  patients and 
society. The recommendations of the project will be based on a thorough analysis of existing 
documents,  a  broad  debate,  and  the  construction  of  scenarios  on  the  possible  consequences 

164 
165 
166 
167 
168 

http://www.cefic.be/Files/Publications/RC_GlobalCharter2006.pdf 
http://www.responsiblenanocode.org/ 
http://nanoriskframework.com/page.cfm?tagID=1095 
(Recital 30) and article 6 of decision on FP7 
http://www.nanomedroundtable.org/ 

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and  impacts  of  nanomedicine.  A  further  aim  is  to  raise  awareness  and  promote  an 
understanding of the field among policy makers and the wider public, and to propose future 
structures to consider issues in nanomedicine. 

Under the Science in Society Programme (in both FP6 and FP7), several projects on the ethics 
and governance of nanotechnology have been funded. The first of these will be completed in 
2009, leading to conclusions on the ethical and public debate on nanotechnology in Europe. 
The support actions and research projects under the Science in Society programme mobilise 
stakeholders  and  facilitate  the  building  of  consensus  for  prospective  research  and  policy 
options in this domain. 
The FP6 project DEEPEN,169 Deepening Ethical Engagement and Participation in Emerging 
Nanotechnologies, was set up to develop an integrated understanding of the ethical challenges 
posed by emerging nanotechnologies in real world circumstances, and their implications for 
civil society, for governance, and for scientific practice. 
The  FP6  project  NanoCap,170  Nanotechnology  Capacity  Building  NGOs,  was  set  up  to 
deepen  the  understanding  of  environmental  and  occupational  health  and  safety  risks,  and 
ethical aspects of nanotechnology. It organised a structured discussion between environmental 
NGOs,  trade  unions,  academic  researchers  and  other  stakeholders  at  the  European  level.  In 
this  way,  it  improved  the  understanding  of  nanotechnologies  and  gave  an  opportunity  to 
formulate  positions  within  their  actual  policy  contexts,  supported  by  scientific  input.  As  a 
result,  five  European  NGOs  adopted  a  position  on  the  responsible  development  of 
nanotechnology,  and  the  European  Trade  Union  Confederation  adopted  a  resolution 
representing 60 million workers in Europe. 
The  FP7  project  NANOPLAT171  will  create  a  forum  on  nanotechnology-based  consumer 
products,  and  evaluate  various  instruments  that  have  been  used  on  the  deliberation  of  the 
societal dimension of nanotechnologies across Europe. 
The  FP7  project  FRAMING  NANO172  will  develop  a  governance  plan  covering  the 
requirements  for  the  safe  development  of  nanotechnology,  on  the  basis  of  a  broad 
international dialogue. 

5.2.2.  Promotion of Alternatives to Animal Testing 

A  particular  requirement  in  EU  policy  relates  to  the  promotion  of  alternatives  to  animal 
testing. Several regulatory instruments, such as the Directive on protection of animals used for 
scientific  purposes,  and  Regulations  on  REACH  and  cosmetics,  call  for  the  promotion  of 
alternative  testing  and  the  refinement,  reduction  or  replacement  of  animal  testing.  The 
cosmetics  legislation  in  particular  has  prohibited  the  use  of  animal  testing  for  cosmetics 
formulations  since  2004;  and  of  acute  toxicity  tests  for  ingredients  since  March  2009.  The 
complete  ban  on  animal  testing,  also  for  long-term  toxicity  studies,  will  come  into  force  in 
March  2013.  In  REACH,  the  promotion  of  alternatives  to  animal  testing  is  one  of  the  main 
aims  of  the  legislation;  its  implementation  will  take  place  in  the  new  testing  proposals  and 
their  evaluation  in  the  European  Chemicals  Agency  (ECHA).  The  Commission  has 
established  a  partnership  with  industry,  is  funding  research  into  alternative  testing  methods, 

169

170 
171 
172 

EN 

http://www.geography.dur.ac.uk/Projects/Default.aspx?alias=www.geography.dur.ac.uk/projec

ts/deepen 
http://www.nanocap.eu/Flex/Site/  
www.nanoplat.org 
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hosts the European Centre for Validation of Alternative Methods (ECVAM), and also works 
on this front in the context of the OECD. Details can be found in sections 1.3, 6.4 and 6.5.  

5.2.3.  European Group on Ethics in Science and New Technologies (EGE) and UNESCO 

Following the adoption by the European Group on Ethics in Science and New Technologies 
(EGE) of an opinion on the ethical aspects of nanomedicine on 17 January 2007,173 the EGE 
may  be  requested  in  the  future  to  extend  its  work  to  broader  nanotechnology  issues,  on  the 
ethics  of  nanotechnology  for  human  enhancement,  biosecurity  and  military  purposes.  The 
EGE is currently working on an opinion on synthetic biology, which is also relevant. 

The  Commission  also  participated  in  the  reflexion  of  UNESCO’s  World  Commission  on 
Ethics of Scientific Knowledge and Technology (COMEST), which led to recommendations 
on nanotechnology and ethics.174 

5.3. 

Transparency and public engagement 

Transparency  and  public  engagement  are  key  factors  in  addressing  societal  concerns 
regarding  the  use  of  nanotechnology,  including  nanomaterials.  The  Commission  considers 
that  dialogue  is  indispensable  for  emerging  technologies  and  that  a  public  acceptance  of 
nanotechnology is crucial for its long-term development.  The  Commission and  a number of 
the Member States have actively promoted broad dialogues on  nanotechnologies, as well as 
numerous other outreach activities. These events have involved public authorities, scientists, 
industry  associations,  consumers,  and  environmental  and  other  non-governmental 
organisations.  Their  coverage  complements  various  other  activities  by  Member  States  and 
international  organisations.  However,  surveys175  have  indicated  that  the  European  public  is 
still not sufficiently aware of nanotechnology. 

The conclusions of the outreach activities detailed later in this section, as well as the activities 
on  ethics  and  governance  described  above,  show  a  need  for  a  more  permanent  public  and 
policy deliberation on nanotechnologies in their broad societal context. The existence of many 
diverse forums suggests that there is a need for an increased monitoring of public and policy 
debate  at  international,  European  and  national  levels,  for  instance  by  FP7  activities  in  the 
years to come. 

5.3.1.  Outreach Projects in FP7 
To  complement  previous  outreach  projects,176  the  Commission  included  in  FP7  a  topic  on 
communication  and  outreach  in  nanotechnology,  resulting  in  the  funding  of  four  projects 
which started in 2009, with a combined EU contribution around EUR 5 million. 

173 

174 

175 

176 

The  EGE  is  an  independent,  multidisciplinary  and  pluralist  advisory  group  advising  the  European 
Commission  on  how  ethical  values  should  be  taken  into  consideration  in  the  preparation  and 
implementation  of  Community  legislation  or  policies.  In  finalising  its  work  the  EGE  received  inputs 
from a number of hearings with experts in the field, decision makers and relevant stakeholders, as well 
as a public round table that took place in Brussels, in March 2006. 
Nanotechnologies  and  Ethics,  Policies  and  Actions,  COMEST  Policy  Recommendations,  UNESCO, 
2007, http://portal.unesco.org/shs/en/ev.php-url_id=11371&url_do=do_topic&url_section=201.html 
e.g. a Eurobarometer survey, 
http://www.ec.europa.eu/research/press/2006/pdf/pr1906_eb_64_3_final_report-may2006_en.pdf 
Nanologue  and  NanoDialogue  projects  of  FP6:  The  Nanologue  project  developed  three  possible 
scenarios  of  the  future development  of nanotechnologies in  its  report  “The  future  of nanotechnology: 
We need to talk”, and developed a “NanoMeter” giving guidance on potential ethical and social issues. 
The  NanoDialogue  project  organised  exhibitions  on  nanotechnology  in  eight  countries,  thereby 
promoting social information and dialogue in the form of focus groups and public debates 

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–  The  NANO-TV  project177  will  raise  the  public  awareness  of  European  nanotechnology 
research, through visual media and the internet. In particular, it will create a series of 14 
high-quality free-of-rights Video News Releases (VNRs) for the general public and young 
people, on the basis of key research results. These will be designed to adapt easily to the 
needs of a wide range of European TV channels. All VNRs will be made available on the 
European  Research  Media  Centre  website.178  Key  nanotechnology  applications  will  be 
presented, addressing possible benefits and implications. The videos and associated written 
material  should  support  a  sound,  science-based  dialogue.  Around  forty  major  television 
networks are expected to broadcast the videos from 2010 onwards. 

–  The  NANOTOTOUCH  project  aims  to  create  innovative  environments,  in  which  broad 
audiences can learn about and discuss nanotechnology, by bringing researchers into contact 
with  the  public.  Three  science  museums  and  three  science  centres  will  cooperate  closely 
with  local  universities  to  create  three  permanent  “Open  Nano-lab”  centres  (in  Munich, 
Milan and Gothenburg) and three “Nano Researcher Live” areas (in Mechelen, Tartu and 
Naples).  Here,  the  visitors  will  experience  live  day-to-day  nanotechnology  research 
conducted  by  young  scientists.  The  process  should  also  offer  role  models  promoting  the 
choice of science as a career. 

–  The  NANOYOU  project179  will  carry  out  a  communication  and  outreach  programme  in 
nanotechnology, aimed at the younger European generation. It should involve at least 400 
schools,  and  engage  with  more  than  25,000  students  and  4,000  young  adults,  through 
programmes  in  schools,  science  centres  and  museums  around  Europe;  and  reach  a  much 
wider  audience  through  its  portal.  The  programme  will  combine  temporary  exhibitions, 
innovative computer games, experiments and other on-line content. Three main application 
areas  of  nanotechnology  (nanomedicine,  energy  and  environment,  and  ICT)  will  be 
addressed. 

–  The  TIMEFORNANO  project180
in  discussions  on 

  aims  to  engage  the  general  public,  and  young  people  in 
particular, 
the  benefits  and  potential  risks  associated  with 
nanotechnology; and to collect opinions and feedback from the participants. The products 
will use an enquiry-based learning approach, specifically developed in science centres and 
museums,  where  people  understand  by  doing.  The  project  will  develop  a  number  of 
informal  education  products:  An  interactive  nano-kit  for  student  groups;  a  yearly  web 
contest for youngsters with an artistic approach; and “nano-days”, events and debates for 
the public at the participating science centres. 

Additionally,  NanoImpactNet,  the  European  Network  on  the  Health  and  Environmental 
Impact of Nanomaterials,181 includes work on an effective two-way communication to ensure 
efficient dissemination of information to stakeholders and the Commission, while at the same 
time obtaining input from the stakeholders about their needs and concerns. 

177 
178 
179 
180 
181 

http://www.nano.org.uk/news/feb2009/latest1786.htm 
http://www.youris.com 
http://www.nanoyou.eu/ 
http://www.timefornano.eu/timefornanoeu/ 
http://www.nanoimpactnet.eu/object_class/nano_men_home.html 

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5.3.2.  Commission workshops on communication and outreach 

In  2007  the  Commission  organised  two  workshops  on  communication  and  outreach  in 
nanotechnology,  with  an  intercalated  open  consultation.182  The  workshops  involved  experts 
from the  fields of philosophy and sociology of science and science communication; science 
centres; and artists and graphic designers. In their conclusions,183 they identified the following 
priorities: 

–  Identifying  and  surveying  target  publics  to  determine  their  values,  concerns  and 
expectations, paying particular attention to “information” (who can reach wider publics). 

–  Developing  new  models  and  tools  for  communication,  dialogue  and  engagement, 

addressing both professional and leisure time. 

–  Stressing the importance of societal choices, with regard to developments. 

–  Ensuring  access  to  reliable  and  high-quality  information  on  ethical,  social  and  legal 

dimensions of nanotechnology and their potential implications for daily life. 

5.3.3.  Commission information tools 

The Commission has published a wide range of information material in many languages and 
for  various  age  groups,  including  films.  The  intention  is  that  at  least  basic  information  be 
available in the EU languages. 
Two  videos  published  by  the  Commission  in  the  past,184  were  complemented  in  2009  by  a 
third,  NanoInLife.  This  contains  a  set  of  supporting  stories  suitable  for  media  use  on  key 
research  results  in  nanotechnology.  The  video  tells  the  story  of  a  young  girl  who  is 
discovering the usefulness of nanotechnology-based products in daily life, through interviews 
with the Nobel Prize winner Harry Kroto and other experts. 

Undoubtedly,  scientists  have  a  role  to  play  in  explaining  the  principles  and  applications  of 
nanotechnology to the general public and the press. To support them in public outreach, the 
Commission  has  made  available  the  handbook  “Communicating  Science  –  a  Scientist’s 
Survival Kit”.185 

Finally,  to  ensure  maximum  transparency,  the  Commission  created  a  specific  entry  on  its 
Europa website for nanotechnology,186 containing an overview of all its activities in the field. 
Frequently  asked  questions  in  five  languages  provide  a  brief  glance  at  the  key  issues  and 
activities. There are also links to more specific websites. 

5.3.4.  Commission dialogues 

Although  public  dialogue  and  public  engagement  at  the  national  level  are  important,  the 
Commission itself maintains an active policy of engagement and consultation. In particular, it 
invites stakeholders to participate on a continuous basis in the regulatory work, and organised 

182 

183 
184 

185 
186 

Workshop  on  Strategy  for  Communication  Outreach  in  Nanotechnology,  in  February  2007;  and 
Workshop on Communication Outreach in Nanotechnology – From Recommendation to Action, on 24-
25 October 2007. 
ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/nanooutreach_action_final_mar_08.doc 
The  first,  Nano:  The  Next  Dimension  (2002),  addressed  a  young  public,  while  the  second, 
Nanotechnology (2003), targeted audiences generally interested in science and technology. 
http://ec.europa.eu/research/science-society/pdf/communicating-science_en.pdf 
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the First and Second Nanotechnology “Safety for Success Dialogues”, in 2007187 and 2008188 
respectively. 

Stakeholders take part as observers in Commission working groups in charge of coordinating 
the implementation of regulation. Examples include the REACH Competent Authorities Sub-
group on Nanotechnologies; the Nanotechnologies Working Group of the Advisory Group on 
the Food Chain, Animal Health and Plant Health; and the Cosmetics Working Group. 

The  annual  workshops,  on  the  other  hand,  have  shown  the  need  for  increased  coordination 
and more exchanges between Member States, regulatory bodies and stakeholders. In addition, 
the  2008  workshop  led  to  the  adoption  of  ten  action  points.  The  “Safety  for  Success 
Dialogues”, have  become  a  major  platform where stakeholders express their  views, both  on 
general  issues  (such  as  the  regulatory  review  and  risk  governance)  and  on  sector-specific 
questions  (for  example,  food,  cosmetics  and  pharmaceuticals).  The  third  event  in  the  series 
will take place on 3-4 November 2009.189 

In  November  2008,  the  Commission  also  organised  in  Brussels  the  first  “International  Risk 
Assessment Conference”,190 to launch the “Global Risk Assessment Dialogue”, where issues 
relevant to nanotechnologies featured prominently. 

5.3.5.  Other dialogues and OECD 

The  call  for  dialogue  and  public  engagement  in  the  Action  Plan  has  also  been  reflected  in 
various other initiatives. The following are only a few examples of the broad range of current 
debates in Europe. 
European industry associations, such as CEFIC, the European Chemical Industry Council,191 
and  CIAA,  the  Confederation  of  Food  and  Drink  Industries  of  the  EU,192  have  set  up 
platforms for dialogue with stakeholders. 

European  Technology  Platforms  (ETPs)  often  have  outreach  activities  and  regularly  consult 
with stakeholders. 

At  national  level,  various  stakeholder  dialogues  took  place  (for  example  in  Austria,  France, 
Germany and the United Kingdom). These either focused on particular sectors or were more 
general in nature; and were either permanent mechanisms (such as in Austria and Germany) 
or one-off events. 

In  the  context  of  the  EU-US  dialogue,  representatives  of  consumer  organisations  meet  with 
regulators, academia and industry from both sides of the Atlantic, on a transatlantic approach 
to issues relevant to consumers. In their meeting of 10 June 2009, consumers had a session on 
“Nanotechnology  in  Food  and  Consumer  Products”.193  A  resolution194  containing  consumer 
requests was presented to the Commission services and US authorities for consideration and 
follow-up. 

The OECD Working Party on Nanotechnology (WPN) organised a “Conference on Outreach 
and  Public  Engagement  in  Nanotechnology”,  in  Delft  on  30  October  2008,  as  part  of  its 

187 
188 
189 
190 
191 
192 
193 
194 

http://ec.europa.eu/health/ph_risk/ev_20071025_en.htm 
http://ec.europa.eu/health/ph_risk/ev_20081002_en.htm 
http://ec.europa.eu/health/ph_risk/ev_20091103_en.htm 
http://ec.europa.eu/health/ph_risk/documents/ev_20081113_lp_en.pdf 
http://www.cefic.be/en/582.html 
http://www.ciaa.be/e-newsletter/nsl2.asp?nsl_id=21&nsldet_id=134 
http://tacd.org/index.php?option=com_docman&task=cat_view&gid=86 
http://tacd.org/index.php?option=com_docman&task=cat_view&gid=75 

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related  project.  The  overall  objective  was  to  look  at  diverse  experiences  with  public 
engagement and discuss best practice.195 The WPN is continuing to work in this area, building 
on the findings so far, with delegate countries undertaking public engagement case studies in 
2009 and 2010. 

(WPMN) 

In  addition,  the  OECD  Working  Parties  on  Nanotechnology  (WPN)  and  Manufactured 
Nanomaterials 
the  “OECD  Conference  on  Potential 
Environmental Benefits of Nanotechnology: Fostering Safe Innovation-led Growth”, in Paris 
on  15-17  July  2009  (see  section  4.6).  This  event  showed  possible  ways  of  benefiting  from 
nanotechnology,  while  ensuring  human  health  and  environmental  safety,  showcasing  in  this 
way “win-win” opportunities for the environment and the economy. 

jointly  organised 

6. 

HEALTH, SAFETY, ENVIRONMENTAL AND CONSUMER PROTECTION 

While  nanotechnology  offers  the  possibility  of  many  beneficial  applications,  the  potential 
impact  of  nanomaterials  on  human  health  and  the  environment  is  not  yet  fully  understood. 
Nanotechnology  products  must  comply  with  the  high  levels  of  consumer,  worker  and 
environmental protection required by the Community. 

The  EU’s  “safe,  integrated  and  responsible”  approach  to  nanotechnologies  means  that 
environmental,  health  and  safety  aspects  must  be  assessed  in  parallel  to  the  evolution  of 
nanotechnology applications. This in turn entails substantial additional research funding and 
the  development  of  dialogues  with  the  involved  actors,  scientific  networks  across  areas  of 
expertise,  and  specific  training.  These  should  be  carried  out  in  cooperation  with  Member 
States,  international  organisations  and  stakeholders,  bearing  in  mind  the  fundamental 
responsibility  of  manufacturers  to  ensure  the  safety  of  their  products.  This  chapter  assesses 
the actions undertaken and progress achieved, and identifies further necessary actions. 

6.1. 

Nanomaterials on the market 

Because  of  the  increasing  number  of  nanomaterials  on  the  market,  there  is  an  increasing 
demand  for  comprehensive  data  on  their  identity,  use  in  various  applications,  and  potential 
impacts  on  human  health  and  the  environment.  In  the  near  future,  reporting  under  various 
regulatory schemes will constitute an important source of information on nanomaterials and 
their  safety.  However,  to  satisfy  current  needs,  the  Commission,  industry  associations, 
international organisations and private companies have conducted a number of studies in this 
regard, which are outlined in this section. 

6.1.1.  Nanomaterials in research and industrial use 

Some  nanomaterials  have  been  produced  for  a  long  time,  for  example  carbon  black  and 
silicon dioxide, while others, such as nano-forms of titanium dioxide and zinc oxide, came to 
the  market  in  the  1970s.  Today,  different  nano-forms  of  metal  oxides  are  produced  in  large 
quantities. 

In  2007  the  OECD-WPMN  identified  fourteen  nanomaterials,  which  were  either  already  on 
the market or deemed likely to come onto the market at the time, and initiated a sponsorship 
programme to test these: 

–  Fullerenes (C60) 

–  Single-walled carbon nanotubes (SWCNTs) 

195 

http://www.oecd.org/document/2/0,3343,en_21571361_41212117_42324482_1_1_1_1,00.html 

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–  Multi-walled carbon nanotubes (MWCNTs) 

–  Silver nanoparticles 

–  Iron nanoparticles 

–  Carbon black 

–  Titanium dioxide 

–  Aluminium oxide 

–  Cerium oxide 

–  Zinc oxide 

–  Silicon dioxide 

–  Polystyrene 

–  Dendrimers 

–  Nanoclays 

Under  the  REACH  Competent  Authorities  Sub-group  on  Nanomaterials  (CASG  Nano), 
CEFIC  and  IMA  presented  in  late  2008  information  on  the  nanomaterials  manufactured  by 
their member companies. These are mostly the ones included in the OECD-WPMN list. 
In June 2009, the European Cosmetics Association (Colipa) presented196 a preliminary list of 
nanomaterials  used  in  currently  marketed  cosmetics:  silicon  dioxide,  titanium  dioxide  and 
zinc oxide are used in the majority of cases; aluminium oxide, carbon black and iron oxides 
are  employed  less  frequently;  and  nano-forms  of  acrylates,  cerium  oxide,  colloidal  gold, 
fullerenes, polyethylene and platinum are used in a few special cases. 

The US Environmental Protection Agency (EPA) published in January 2009 an intermediate 
report  from  its  Stewardship  Programme  for  Nanomaterials.197 This publication refers  to  123 
nanomaterials, including various forms of the same substance as separate nanomaterials. Half 
of  the  nanomaterials  were  produced  at  laboratory  scales,  and  some  50  of  them  by  one 
company  only.  The  additional  nanomaterials,  made  at  volumes  comparable  to  those 
mentioned  above,  were  lithium  titanate,  antimony  pentoxide,  dimethyl  siloxide,  silanamine, 
cluster diamonds, manganese oxide, aluminium hydroxide, magnesium oxide, calcium oxide, 
copper  (II)  oxide,  palladium,  platinum,  cobalt,  rhodium  and  a  quantum  dot.  It  is  unknown 
whether these nanomaterials are on the European market. 

Also early in 2009, the European Commission services compiled a preliminary overview of 
nanomaterials on the market, for the use of the CASG Nano. It concluded that in addition to 
those listed above, more are being sold on-line for research and industrial purposes. These are 
aluminium,  antimony  oxide,  barium  carbonate,  bismuth  oxide,  boron  oxide,  calcium  oxide, 
chromium oxide, cobalt oxide, dysprosium oxide, germanium oxide, indium oxide, lanthanum 
oxide,  molybdenum  oxide,  neodymium  oxide,  nickel,  niobium,  palladium,  praseodymium 
oxide, samarium oxide, tantalum, terbium oxide, tungsten, yttrium oxide and zirconium oxide, 
as well as metals and metal composites. Of these, only dysprosium oxide and samarium oxide 
have not been pre-registered under REACH as phase-in substances. 

On the basis of these evaluations it can be concluded that a variety of nanomaterials are sold 
on  the  global  market  for  research  or  industrial  purposes.  In  cases  where  these  are 

196 
197 

http://tacd.org/index2.php?option=com_docman&task=doc_view&gid=249 
http://www.epa.gov/oppt/nano/nmspfr.htm 

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manufactured in the EU or imported into the EU, the majority of the substances from which 
these nanomaterials have been derived seem to have been pre-registered to ECHA as phase-in 
substances.198 
Various  studies  indicate199  that  the  nanomaterials  available  in  appreciable  quantities  on  the 
global market fall into the following groups, in order of current market volumes in monetary 
terms: 

–  Ceramic  nanoparticles  including  metal  oxides  (e.g.  titanium  dioxide,  zinc  oxide,  iron 
oxide);  metal  sulphides  and  nitrides;  and  other  inorganic  compounds,  all  possibly  coated 
with layers of polymers, surfactants, or other inorganic materials. 

–  Metal nanoparticles, most commonly silver, gold, aluminium and nickel.  

–  Nanoporous  materials  (e.g.  silicon  dioxide,  carbon,  aluminium  oxide,  various  polymers, 

metals and silicon). 

–  Carbon nanotubes (single, multi- or double-walled nanotubes). 

–  Fullerenes and POSS (made of silicon and oxygen atoms). 

–  Other carbon nanomaterials (e.g. carbon black, graphite, nanoherring). 

–  Quantum dots, dendrimers. 

–  Nanostructured materials (e.g. metal grains and layers of various materials). 

–  Nanowires, including metallic and semiconducting wires. 

–  Nanopolymers (e.g. nanostructured polymers and fibres). 

–  Bionanomaterials (e.g. oligonucleotides, peptides, proteins and bioactive molecules). 

–  Nanoencapsulations (e.g. liposomes, micelles, solid lipids, polymersomes, emulsions). 

–  Nanoclays (e.g. layered platelets of clays, generally aluminosilicate ceramic materials). 

These materials are used in industrial sectors such as manufacturing, aerospace, automotive, 
electronics, medicine and pharmaceuticals, oil and gas, in addition to construction, energy and 
environmental applications (see Annex 2). 

Specific  applications  of  ceramic  nanomaterials  are,  for  example,  in  metal  and  composite 
coatings  for  aerodynamic  surfaces;  and  in  coated  parts  to  withstand  extreme  heat  and 
pressure,  enhance  appearance,  prevent  deposits,  or  improve  engine  efficiency.  Titanium 
dioxide  nanomaterials  are  used,  for  example,  in  various  coatings  (e.g.  water,  dirt  and 
contamination  repellent,  self-cleaning,  non-stick  or  UV-resistant  coatings).  Nanoporous 
materials are used for insulation (aerogels). 

Metal  nanoparticles  vary  greatly  in  their  functions.  Silver  nanoparticles  and  other  noble 
metals  figure  in  health  care  (e.g.  as  antibacterials  for  medical  instruments  and  fabrics,  and 
aluminium  coatings  for  prosthetics),  while  magnetic  iron-based  alloys  are  used  for  energy 
transmission,  and  light  metals  are  used  in  structural  applications.  Nanostructured  alloys  and 
carbon  nanotubes  render  steel  much  stronger.  Specially  engineered  metal  nanoparticles 
improve  properties  like  flow  and  dispersion.  There  are  coatings  based  on  polymers  and 
organic-inorganic  particles;  and  filtration  solutions  using  hollow  nanofibres  or  antifouling 
coatings. 

198 
199 

Phase-in substances are, e.g., those previously listed in EINECS 
NanoRoadSME and ObservatoryNANO projects; and Lux Research 

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Carbon nanotubes are used, for example, in polymer composites or foams with high electrical 
conductivity,  in  wiring,  strengthening  of  cement,  nanostructured  devices  for  active  cooling 
with  highly  conductive  features,  embedded  in  epoxy  enabling  stronger  wind  turbine  blades, 
and for sensors. Fullerenes are used, for example, as fillers and in some cosmetics, as well as 
for resists, anti-static packaging, and nanoimprint lithography.  

As regards other carbon nanomaterials, carbon black is used for applications such as car tyres, 
antistatic textiles, cosmetics and colouring; nanographite for pigment production, as additive 
to rubber and plastics, and in electrode materials for batteries, fuel cells and supercapacitors; 
graphitic nanoherring in catalysts; and graphene in electronic applications, such as transparent 
conductive films, transistors and sensors. 

Quantum  dots  can  be  used  for  diagnostics,  bio-labels  and  next-generation  solar  cells,  while 
quantum  dots  and  dendrimers  boost  LED  output  and  enable  precision  optical  elements. 
Nanostructured  materials,  such  as  nanostructured  metallic  alloys  and  nanoporous  materials, 
are  used  for  stronger  and  lighter  aircraft  and  automotive  parts.  They  also  enhance  the 
performance  of  rechargeable  batteries  and  catalytic  converters.  Diamond  nanocrystals  and 
nanostructured metal composites enable more durable industrial parts. 

Metallic and semiconducting nanowires are used for smaller, faster microchips and memory 
devices, but also for displays, energy storage devices and sensors. Nanopolymers are used in 
transport and by packaging industries; and nanofibres for filtration of air or liquids. 

Engineered  biomolecules  (oligonucleotides,  peptides,  proteins  and  bioactive  molecules)  are 
used for light-control materials and bio-based packaging materials. Liposomes, micelles, solid 
lipids,  polymersomes,  emulsions  and  silicon  dioxide  shells  are  used  as  encapsulators,  for 
example to improve the solubility and bioavailability of ingredients, to protect molecules from 
degradation, to shield undesirable qualities like taste or smell, to provide optical clarity, or to 
improve the texture of a cosmetic product. 

Nanoclays are layered platelets of clays used primarily as polymer additives, for example in 
heat-resistant thermoplastics and lightweight and strong moulded automotive parts. 

6.1.2.  Nanomaterials in consumer products 

Although  the  overall  share  of  consumer  products  based  on  nanotechnology  is  small, 
consumers may have a direct contact with several types of such products, and may be directly 
exposed to them in everyday life. 

The Woodrow Wilson database collects information on products that are advertised on-line in 
English and make nanotechnology claims. Such claims are often not substantiated, but rather 
used  for  unsupported  publicity  purposes.  The  Commission  services  have  also  made  an 
assessment of the database and concluded that, of the 755 products covered in January 2009, 
one  third  made  “nano”  claims  without  any  specification  of  the  nanomaterials  used.  Typical 
consumer  products  containing  nanomaterials  include  cosmetics,  sunscreens,  cleaning 
products, anti-stain coatings, textiles, paints, and so on. The number of nanomaterials used is 
relatively  small  (silver,  titanium  dioxide,  zinc  oxide,  carbon,  silicon  dioxide,  fullerenes, 
fullerols, carbon nanotubes, nanomicelles, nanospheres and nanoparticles). The most common 
claims concern the antimicrobial effects of silver. 

In order to get a more robust understanding of the current market situation with regard to the 
legislative  requirements,  that  is,  thresholds  for  registration  under  REACH,  the  Commission 
services asked a contractor to investigate what nanomaterials are on the EU market today and 
indicate their potential volumes. A conference to discuss the findings took place on 9 October 
2009, and the Commission services will take these results into account in their further work. 

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6.1.3.  Regulatory reporting 
REACH200 and CLP201 will provide knowledge about the safety of nanomaterials, their uses 
and volumes. Information from the implementation of these Regulations is also the foundation 
for  a  number  of  other  legislative  areas.  Irrespective  of  the  volumes  put  on  the  market,  CLP 
provides  for  the  classification  and  labelling  of  hazardous  substances  and  their  forms 
(including nanomaterials), and this information is used in legislation. Examples are Directive 
98/8/EC202  of  the  European  Parliament  and  of  the  Council  on  the  placing  on  the  market  of 
biocidal  products;  and  Council  Directive  91/414/EEC203  concerning  the  placing  of  plant 
protection products. 

Under REACH moreover, substances manufactured or imported in volumes of one tonne per 
year  or  more  have  to  be  registered  with  the  European  Chemicals  Agency  (ECHA).  This 
provides  information  relevant  to  the  risk  assessment  and  risk  management  of  substances 
throughout the supply chain. 

REACH  entered  into  force  on  1  June  2007,  and  CLP  on  20  January  2009.  The  registration 
deadlines are determined by the total tonnage204 or toxicity of the substance manufactured or 
imported.  The  first  registration  deadline  is  30  November  2010  –  for  substances  at  1,000 
tonnes per year or more. This deadline also applies to carcinogens, mutagens and reproductive 
toxicants  (CMRs)  with  production  of  one  tonne  or  more  per  year;  and  persistent  and 
bioaccumulative  toxicants  (PBTs)  with  production  of  100  tonnes  or  more  per  year.  The 
deadline for the notification to the CLP Inventory of ECHA is generally 3 January 2011. A 
considerable  amount  of  information  stemming  from  these  reportings  can  therefore  be 
expected in 2011. There are already two examples of registrations of nanomaterials submitted 
to ECHA – silicon dioxide and carbon black. 

Information on the most commonly used nanomaterials will gradually become available after 
the first set of REACH registrations of high-volume chemicals and the CLP notifications of 
all  hazardous  substances  by  the  end  of  2010.  The  former  provides  a  safety  dossier  for  each 
substance, including different forms and states, while the latter provides available information 
of hazard classes of substances (including their different forms and states). This will in turn 
enable the further assessment of their safety and the risk management measures in place. In 
line with the conditions set out in the regulations, ECHA will assess the information and make 
the data publicly available via its website.205 

Information on what nanomaterials are on the market will also become increasingly available 
from  pre-market  intervention  schemes  under  sector-specific  regulation.  In  particular, 
regulatory  change  has  been  made  for  cosmetic  products,  meaning  that  nanomaterials  which 
are  not  already  subject  to  pre-market  authorisation  (i.e.  preservatives,  colorants  and  UV 
filters)  will  be  subject  to  a  notification  six  months  before  they  are  placed  on  the  market.  If 
necessary,  the  Commission  will  be  able  to  ask  the  EU  Scientific  Committee  for  Consumer 
Safety (SCCS) for an assessment of the materials. 

200 
201 
202 
203 
204 

205 

Registration, Evaluation, Authorisation and Restriction of Chemicals (EC Regulation 1907/2006) 
Classification, Labelling and Packaging of substances and mixtures (EC Regulation 1272/2008) 
O.J. L 123 24.4.1998, P. 1 
O.J. L 230 19.8.1991, P. 1 
Where  a  nanomaterial  is  produced  together  with  its  “parent”  substance,  the  total  tonnage  of  the 
substance  is  used  for  the  determination  of  its  registration  timeline  and  respective  information 
requirements. 
http://echa.europa.eu/ 

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Furthermore, the Regulation on Food Additives206 explicitly stated that a significant change in 
the production method or in particle size (e.g. preparation in nano-form) of an approved food 
additive  would  require  a  re-evaluation  of  the  substance  by  the  European  Food  Safety 
Authority  (EFSA)  and  a  new  authorisation.  No  application  for  an  EU  authorisation  under 
novel food legislation has been made so far. However, because of the current lack of a legal 
definition  of  nanomaterials,  there  could  be  some  discrepancies  with  respect  to  the 
interpretation and enforcement of the EU food legislation as regards the use of nanomaterials 
in  food.  It  is  expected  that  the  revision  of  this  legislation  will  bring  about  the  necessary 
clarity. 

6.1.4.  Further work 

The  analyses  above  are  all  based  on  publicly  available  information.  There  are  also 
uncertainties  surrounding  what  exactly  is  understood  as  being  a  nanomaterial.  Such 
uncertainties notwithstanding, there seems to be a convergent view of what nanomaterials are 
on the market. Some have been present for a long time. A small proportion of nanomaterials 
can be found in consumer products. Most nanomaterials currently on the market will probably 
be registered together with the substances from which they have been derived. 

However, the Commission is aware of the need to get a better and more accurate overview of 
nanomaterials on the market. In line with its policy objectives, and in the light of the debate in 
the European Parliament on nanomaterials, the Commission intends to present information on 
the types and uses of nanomaterials, including safety aspects in 2011. 

6.2. 

Regulation 

6.2.1.  Regulatory Review 

In June 2008, the European Commission adopted the Communication “Regulatory Aspects of 
Nanomaterials”.207  This  regulatory  review  reflected  a  commitment  expressed  in  the  Action 
Plan  (Action  6d).  The  Communication  was  accompanied  by  a  Commission  Staff  Working 
Document “providing a summary of legislation in relation to health, safety and environment 
aspects of nanomaterials, and outlining regulatory research needs and related measures”.208 

According to the regulatory review, existing EU  legislation  covers in principle the potential 
health,  safety  and  environmental  risks  in  relation  to  nanomaterials.  Certain  aspects  of 
production and products are at the same time subject to various Community provisions. The 
protection of health, safety and the environment needs to be enhanced largely by improving 
implementation  of  current  legislation.  Nevertheless,  the  Commission  acknowledges  that 
regulatory changes may be needed in light of new information becoming available. 

The  implementation  of  regulation  is  facilitated  by  different  types  of  documents,  adopted 
within  the  regulatory  frameworks,  such  as  implementing  legislation,  European  standards, 
regulatory and technical guidance documents. These will need to be adapted in order better to 
cover  environmental  and  health  risks  in  relation  to  nanomaterials.  To  do  this,  however, 
improved  methods  are  needed  for  the  characterisation  of  nanomaterials;  the  assessment  of 
potential hazards, exposure and risks; and risk management measures. 

(EC Regulation 1333/2008) 
Regulatory Aspects of Nanomaterials, COM(2008)366; 

206 
207 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0366:FIN:en:PDF 
208 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2008:2036:FIN:EN:PDF 

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The Commission and relevant EU Agencies are in the first place reviewing current documents 
that  support  implementation,  such  as  implementing  legislation,  standards  and  technical 
guidance, with regard to their applicability to, and appropriateness for, nanomaterials. 

Commission working groups in charge of coordinating the implementation of legislation are 
examining on an ongoing basis whether regulatory change on specific aspects is necessary. In 
so doing, they are taking into account the continuously generated information addressing the 
identified  knowledge  gaps,  and  relevant  work  that  has  been  carried  out  at  national  and 
international level. 
In an opinion adopted on 24 April 2009,209 the European Parliament questions whether, in the 
absence of any provisions in Community law  specific to nanotechnology, legislation  can be 
deemed  adequate  to  cover  the  risks  related  to  nanomaterials.  Given  the  lack  of  appropriate 
data and assessment methods, the Parliament considers that regulatory change is necessary to 
address risks in relation to nanomaterials in an appropriate way. The Parliament therefore asks 
the Commission to review all relevant legislation within the next two years, to ensure safety 
over  the  whole  life  cycle  of  nanomaterials  in  products.  The  Parliament  considers  it 
particularly  important  to  address  nanomaterials  explicitly,  at  least  within  the  scope  of 
legislation on chemicals, food, waste, air and water, and worker protection. In evaluating the 
need  to  review  EU  legislation  (REACH,  waste  legislation,  air  and  water  legislation,  and 
worker  protection),  the  Commission  will  pay  particular  attention  to  the  issues  suggested  by 
the Parliament, and report on its conclusions from the review process referred to above. The 
Parliament’s opinion also includes a number of specific requests to the Commission, related 
to  certain  aspects  of  regulation,  labelling,  ethics,  the  involvement  of  stakeholders,  fact-
finding, research and coordination. 

The  European  Economic  and  Social  Committee  (EESC)  also  adopted  an  opinion  on  the 
regulatory review in its session of February 2009.210 According to the EESC, a foresight for 
risk  assessment  of  nanotechnology  products  should  be  developed,  along  with  an  integrated 
regulatory frame of reference and a joined-up system of governance at international level, to 
give clear, reliable and complete answers on the ethical impact, the possible risks for health 
and the environment, and possible developments in these areas. 

The Commission has undertaken to present a new report in 2011, paying particular attention 
to  a  number  of  points  raised  by  the  European  Parliament  and  the  European  Economic  and 
Social  Committee.  In  the  light  of  the  various  actions  mentioned  in  this  section,  the 
Commission also intends to present in 2011 information on types and uses of nanomaterials, 
including safety aspects. 

6.2.2. 

Sectoral developments 

The European Parliament and the Council have agreed on a recast of the Cosmetics Directive. 
In addition to the earlier pre-market authorisation of UV filters, colorants and preservatives, 
the  new  regulation  introduces  various  provisions  specific  to  other  nanomaterials.  These 
provisions  include  a  notification  obligation  for  manufacturers  regarding  the  presence  of 
nanomaterials in cosmetics not subject to prior authorisation; a possibility for the Commission 
to request a safety assessment for such materials by the Scientific Committee for Consumer 
Safety (SCCS); and a labelling requirement for nanomaterial ingredients. The new regulation 

P6-TA-2009-0328, 

209 
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2009-0328 
210 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:218:0021:0026:EN:PDF 

2009/C 218/04, 

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introduces  a  definition  of  nanomaterials  used  in  cosmetics  ingredients.  It  also  introduces  an 
obligation on manufacturers to notify to the national competent authorities serious undesirable 
effects of products known to the manufacturers, or which should reasonably be expected to be 
known to them. The recast will formally be adopted, as a regulation, by the end of 2009. 

In the context of discussions on a modification of the regulation on novel food, the European 
Parliament  has  proposed  various  provisions  specific  to  nanomaterials.  In  particular,  it  is 
proposed to make it explicit that the use of nanotechnologies or nanomaterials for food and 
food  ingredients  already  authorised  will  require  a  new  authorisation.  However,  discussions 
continue as part of the second reading.  

The introduction of provisions specific to nanomaterials naturally requires the adoption of a 
definition.  The  regulation  on  cosmetics  and  the  new  regulation  on  novel  food  therefore 
introduce a definition. However, in view of the various definitions of nanomaterials published 
by  different  bodies,  and  the  constant  technical  and  scientific  developments  in  the  field,  the 
Commission  is  given  a  mandate  to  adjust  these  definitions  in  the  light  of  technical  and 
scientific  progress,  and  to  align  them  with  definitions  subsequently  agreed  at  international 
level. 

In the area of chemical substances, particularly relevant to nanomaterials, a specific group of 
competent authorities was created in March 2008, namely the REACH Competent Authorities 
Sub  Group  on  Nanomaterials  (CASG  Nano),  to  discuss  how  REACH  applies  to 
nanomaterials.  The  objective  is  to  exchange  views  on  existing  and  future  implementation 
issues, and other matters related to nanomaterials under REACH. On this basis, the group will 
provide  recommendations  to  the  REACH  Competent  Authorities,  advising  the  Commission. 
Stakeholders are invited to participate in the meetings. 

So far, three official meetings and an informal workshop have been held. The sub-group has 
established  a  work  programme  up  to  2012,  based  on  the  implementation  deadlines  under 
REACH.  The  group  issued  its  first  paper  “Nanomaterials  in  REACH”,211  endorsed  by  the 
REACH  Competent  Authorities  meeting  in  December  2008.  The  group  has  also  started  a 
REACH  Implementation  Project  on  Nanomaterials,  called  RIPoN,  to  carry  out  further 
technical  work  on  substance  identification,  information  requirements  and  chemical  safety 
assessment. This will allow research results to be integrated with the further adjustment of the 
REACH implementation guidance for specific aspects of nanomaterials. 

The Commission will propose a review on the Seveso II Directive in 2010, to align its Annex 
I to the UN Global Harmonisation System (UNGHS).  The  Commission  continues  to  follow 
carefully  the  issue  of  nanomaterials,  also  considering  relevant  research  projects.  The  issue 
will be also addressed in OECD, in the project “Prevention of major accidents resulting from 
nanotechnologies” (included  in  the  2009-2012  Work  Programme  of  the  OECD  Working 
Group on Chemical Accidents and OECD-WPMN). 

In the Commission’s proposal for a Regulation concerning the placing on the market and use 
of biocidal products,212 active substances at the nanoscale are implicitly included in the term 
“active  substances”.  The  proposed  Regulation  will  repeal  and  replace  the  current  Directive 
98/8/EC concerning the placing of biocidal products on the market. 

http://ec.europa.eu/enterprise/sectors/chemicals/reach/nanomaterials/index_en.htm, 

211 
http://ec.europa.eu/environment/chemicals/nanotech/index.htm 
212 

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The  European  Food  Safety  Authority  (EFSA)  has  evaluated  an  application  for  the  use  of 
titanium nitride (TiN) nanoparticles in PET213 bottles. The petition is based on the assumption 
that  TiN  nanoparticles  do  not  migrate  into  food.  EFSA  concluded  in  November  2008  that 
there  is  no  safety  concern,  as  the  substance  does  not  migrate  into  food.  The  Commission  is 
currently  reflecting  on  the  impact  of  the  authorisation  of  this  substance,  taking  into 
consideration  relevant  factors  of  Community  law.  EFSA  also  made  a  statement  in  2008 
related  to  an  application  of  silver  hydrosol:  As  the  data  submitted  by  the  petitioner  were 
insufficient  to  characterise  adequately  silver  hydrosol  for  risk  assessment,  no  opinion  was 
produced. Finally, in 2007 EFSA gave an opinion on silicon dioxide in nanoparticle form for 
coating PET bottles. However, as legislation on coatings is within the competence of Member 
States, no action was taken by the Commission. 

The European Medicines Agency (EMEA), with its experts within the scientific committees 
(coordinated  by  the  Innovation  Task  Force),  continues  to  support  applicants  during  the 
development of nanomedicines. A number of scientific and regulatory aspects warrant further 
scientific  research  and  debate  (e.g.  the  impact  of  nanopharmaceutical  components  on 
biological  systems,  definition  and  borderline  products,  and  impact  on  the  evaluation  of 
innovative  nanomedicines).  Nevertheless,  the  pharmaceuticals  regulatory  framework  allows 
for  a  scientifically  well-defined  and  robust  evaluation  of  benefit-risk  balance,  on  a  case-by-
case basis, for each nanomedicine submitted to the Agency. 

An  ad  hoc  expert  group  on  nanomedicines  (including  academic  specialists  and  regulatory 
scientists) was established recently to provide specialist input on new scientific and regulatory 
issues emerging in the development of novel nanopharmaceuticals, and to assist the EMEA in 
the review of guidelines, in order to identify any relevant gaps and further needs for guidance. 
In addition, the EMEA continues to contribute to the international activities in the sector and 
is  now  in  the  lead  of  an  informal  international  technical  group,  which  was  set  up  as  an 
outcome of the regulatory meetings launched by the FDA in 2006. An international workshop 
focusing on scientific aspects of nanomedicine development and evaluation will be held at the 
EMEA in April 2010. 

The Commission strategy on health and safety at work for the period 2007-2012 recognises 
nanotechnology as an important area of work in the context of identifying emerging risks. In 
this context, the European Agency for Safety and Health at Work (EU-OSHA) published in 
2009  a  European  Risk  Observatory  report  on  workplace  exposure  to  nanomaterials.  This 
report  identifies  priorities  for  future  action,  such  as  identification  of  nanomaterials; 
description  of  exposure  scenarios;  measurement  of  exposures  to  nanomaterials;  efficacy  of 
protective measures; in vivo studies for assessment of adverse health effects of nanomaterials; 
validation  of  in  vitro  methods;  and  methods  for  the  characterisation  of  physicochemical 
properties. 

The Commission is aware that discussions are taking place at national level in some Member 
States, regarding legislative initiatives on nanomaterials. However, so far, no draft regulation 
regarding  nanomaterials  has  been  notified  to  the  European  Commission  under  Directive 
98/34/EC,  which  lays  down  a  procedure  for  the  provision  of  information  in  the  field  of 
technical standards and regulations.214 

213 
214 

Polyethylene terephthalate 
Official Journal L 204 , 21/07/1998 p. 0037 - 0048 

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Safety concerns associated with the use of nanomaterials 

6.3. 
According  to  the  opinions  of  the  EU  Scientific  Committees,215  not  all  nanomaterials  induce 
toxic  effects.  The  Scientific  Committees  stress  that  the  hypothesis  that  smaller  necessarily 
means more toxic cannot be substantiated by the published data. However, certain health and 
environmental  hazards  have  been  identified  for  a  variety  of  manufactured  nanomaterials, 
indicating  potential  toxic  effects.  Long,  non-degradable,  rigid  nanotubes  (longer  than  20 
micrometres)  have  in  several  experiments  been  found  to  have  effects  similar  to  hazardous 
asbestos, causing inflammatory reactions for instance. Experiments also indicate that carbon 
nanotubes  with  these  characteristics  could  induce  a  specific  form  of  lung  cancer, 
mesothelioma,  which  is  also  observed  in  relation  to  asbestos  exposure.  Whether  such 
nanotubes would pose a risk for humans is not known but cannot be ruled out. 

This means that nanomaterials are similar to other substances, in that some may be toxic and 
some may not, and some may be toxic only under certain exposure conditions. As there is not 
yet  a  generally  applicable  paradigm  for  the  identification  of  potential  hazards  of 
nanomaterials, the Scientific Committees continue to recommend a case-by-case approach for 
the risk assessment of nanomaterials. 

Scientific knowledge about health, safety and environmental (HSE) aspects of nanomaterials 
is a critical factor for the implementation of safety legislation. Therefore, research efforts have 
intensified  over  the  last  five  years  or  so  –  at  the  EU  level,  in  Member  States  and 
internationally. To develop a sound knowledge base, targeted actions to address HSE issues 
have  been  launched  through  the  Research  Framework  Programmes  and  the  Commission’s 
Joint Research Centre, and international collaboration has been intensified. 

As  with  ordinary  chemicals,  the  risk  assessment  of  nanomaterials  depends  on  the 
identification  of  hazards  and  exposures.  However,  the  science  needed  to  test  and  measure 
hazards and exposures is more complex for nanomaterials than for ordinary chemicals. Their 
small  size  requires  analytical  tools  with  high  resolution  and  precision.  Their  reactivity  and 
tendency readily to undergo changes when in contact with surrounding media require careful 
characterisation  of  test  samples  and  the  use  of  experimental  setups  able  to  ensure 
reproducibility. 

These  basic  scientific  issues  have  constituted  a  major  hurdle.  Some  years  ago,  conflicting 
experimental  results  that  were  hard  to  explain  and  interpret  were  not  uncommon.  The 
situation  has  greatly  improved;  in  particular,  progress  has  been  made  in  understanding  the 
interaction mechanisms of nanomaterials with biological systems, and in the areas of analysis 
and measurement. However, there are still considerable uncertainties and knowledge gaps in 
assessing the short- and long-term risks of different nanomaterials for human health and the 
environment.  According  to  a  recent  study  by  the  Institute  of  Occupational  Medicine  (IOM, 
April 2009),216 based on an inventory of 260 research projects, the minimum amount of data 
required to make limited risk assessments was available for only three nanomaterials: carbon 
nanotubes  (for  health  risks),  and  nano-titanium  dioxide  and  nano-silver  (for  environmental 
risks). 

At the request of the Commission, the EU Scientific Committees advise on the potential risks 
of  nanomaterials  and  respective  methodologies.  Since  2005,  the  Commission  has  requested 
six opinions. The EU Scientific Committee on Emerging and Newly Identified Health Risks 

215 

216 

on Emerging and Newly Identified Risks (SCENIHR), on Consumer Products (SCCP) and on food and 
feed in the European Food Safety Authority (EFSA) 
http://www.iom-world.org/research/nanoparticles.php 

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(SCENIHR)  has  delivered  four  opinions  on  nanomaterials;217  the  Scientific  Committee  on 
Consumer Products (SCCP) has published one on nanomaterials in cosmetic products;218 and 
the  Scientific  Committee  of  the  European  Food  Safety  Authority  (EFSA)  provided  one 
opinion  about  potential  risks  of  nanomaterials  in  food  and  feed.219  Finally,  the  European 
Medical  Agency  (EMEA)  has  published  a  concept  paper  on  nanotechnologies,220  which  it 
applies in its work. 

6.4. 

Analysis of research on health, safety and environmental issues 

This section builds on research results from European projects, including those described in 
section  1.3,  and  other  research  results,  drawing  conclusions  regarding  their  use  in  risk 
assessment and management of nanomaterials. The next section presents the needs for further 
research, taking the knowledge gaps into account. 
Progress  has  been  made,  and  continues  to  be  made,  in  the  characterisation221  and  exposure 
assessment  methods  for  nanomaterials,  in  toxicokinetics  and  genotoxicity  testing  with 
mammalian  cells,  and  in  the  environmental  behaviour  of  nanomaterials.  Numerous  in  vitro 
studies  have  shown  that  some  nanomaterials  induce  oxidative  stress  at  high  concentrations. 
However, there is not enough information for drawing general conclusions on the relationship 
between  the  physicochemical  properties  of  nanomaterials  and  toxicity,  either  in  vivo  or  in 
vitro. Recent research has also identified new concerns related to in vitro studies on protein 
fibrillation  processes  (both  enhancement  and  retardation);222  to  potential  hazards  created  by 
certain types of nanotubes;223 to the potential of some nanoparticles to act as carriers for other 
contaminants (“Trojan horse” effect);224 and to the potential for transfer across the food chain 
in environmental species.225 

217 

The  first  SCENIHR  opinion  in  2006  addressed  “The  appropriateness  of  existing  methodologies  to 
assess the potential risks associated with engineered and adventitious products of nanotechnologies“ in 
general terms: 

http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf 
The second opinion in 2007 dealt with “The appropriateness of the risk assessment methodology in accordance 
with  the  Technical  Guidance  Documents  for  new  and  existing  substances  for  assessing  the  risks  of 
nanomaterials”: 

http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_010.pdf 
This was followed in late 2007 by an opinion on “The scientific aspects of the existing and proposed definitions 

relating to products of nanoscience and nanotechnologies“: 

223 

“Safety of nanomaterials in cosmetic products”: 

The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety: 

http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_012.pdf 
218 
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_123.pdf 
219 
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/sc_op_ej958_nano_en,0.pdf 
220 
221 
222 

http://www.emea.europa.eu/pdfs/human/genetherapy/7976906en.pdf 
That is, the determination of properties 
Linse S, Cabaleiro-Lago C, Xue W-F, Lynch I, Lindman S, Thulin E, Radford S E, and Dawson KA, 
Nucleation of protein fibrillation by nanoparticles, PNAS, 2007, 104, 8691-8696 
Poland C, Duffin R, Kinloch I, Maynard A, Wallace WAH, Seaton A, Stone V, Brown S, MacNee W 
and Donaldson K, Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like 
pathogenicity in a pilot study, Nature Nanotechnology, 20 May 2008 
See, e.g., 

224 
http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/sc_op_ej958_nano_en,0.pdf?ssbinary=true 
225 
-Holbrook RD, Murphy KE, Morrow JB, Cole KD, Trophic transfer of nanoparticles in a simplified 
invertebrate food web, Nat Nanotechnol 2008; 3:352-5; 
-Fortner JD, Lyon DY, Sayes CM, Boyd AM, Falkner JC, Hotze EM, et al., C60 in water: nanocrystal 
formation and microbial response, Environ Sci Technol 2005; 39:4307-16; 
-Bouldin JL, Ingle TM, Sengupta A, Alexander R, Hanningan RE, Buchanan RA, Aqueous toxicity and 

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6.4.1.  Characterisation, metrology and reference materials 

A  number  of  available  measurement  and  analytical  methods  are  generally  applicable  at  the 
nanoscale. However, these need to undergo formal validation and harmonisation, especially at 
low-nanometre resolutions. The area is research-intensive because of the many ambiguities in 
the  work  with  nanomaterials.  In  this  respect,  and  especially  for  specific  nanomaterials,  it  is 
important to note that particle size distribution is not a fundamental property of the material 
being  studied,  but  a  temporary  state  of  dynamic  equilibrium  between  dispersion  and 
agglomeration  in  suspensions  or  aerosols.  This  clarification  will  allow  unambiguous 
interpretations of test and measurement results to be obtained, and boost their further use in 
guidance documents for the implementation of regulations. 

If  specific  requirements  regarding  nanoparticle  characterisation  are  to  be  imposed  by 
regulation,  this  will  entail  an  operational  quality  assurance  system  for  laboratories.  In  this 
context,  the  activities  of  EU  producers  of  reference  materials  are  highly  relevant.  An 
increasing number of reference materials are becoming available, including those produced by 
the Commission’s JRC.226 However, most of these reference materials are not certified, which 
means that they have to be upgraded to provide the level of confidence required for regulatory 
purposes, including formal laboratory accreditation. 

The Commission gave a mandate to the European Standards Bodies (CEN/CENELEC/ETSI), 
inviting them to present a programme of standardisation needed to support the introduction to 
the  market  of  nanomaterials  and  nanotechnologies  (details  are  given  in  sub-section  4.4.4). 
CEN presented a programme in May 2008, providing an overview of ongoing activities and 
needs, which are highly relevant inter alia to risk assessment. The Commission has finalised a 
new  mandate,  including  standardisation  of  characterisation  and  exposure  measurement 
methods. 

6.4.2.  Potential human health hazards 

First  and  foremost,  it  is  essential  to  obtain  a  regular  and  extensive  characterisation  of  the 
nanomaterial  in  question  immediately  preceding  testing,  to  ensure  the  usefulness  of  the  test 
results. It is further clear that this has to be complemented by an additional characterisation of 
the form of the nanomaterial that is actually being introduced into the test systems. This is to 
ensure that the test results are actually linked to the nanomaterial in question, rather than to an 
artefact,  or  to  a  degraded  or  further  aggregated  or  agglomerated  form  that  is  substantially 
different  from  the  form  to  be  tested.  This  is  also  consistent  with  scientific  opinions 
(SCENIHR, SCCP and EFSA). 

In  relation  to  human  toxicology,  substantial  progress  has  been  achieved  within  the  OECD-
WPMN as part of (i) reviewing the various test guidelines available;227 and (ii) guidance for 
sample  preparation  and  dosimetry.  In  general,  the  OECD  guidelines  are  applicable  to 
investigating  the  health  effects  of  nanomaterials  with  the  important  proviso  that  additional 
consideration needs to be given to the physicochemical characteristics of the material tested, 
including dosing. In some cases, there may be a need for further modification to the OECD 
guidelines. Preparation of samples and dose administration are critical considerations for the 

food chain transfer of quantum dots in freshwater algae and Ceriodaphnia dubia, Environ Toxicol 
Chem 2008; 27:1958-63; 
-Petersen EJ, Huang Q, Weber WJ Jr, Bioaccumulation of radio-labelled carbon nanotubes by Eisenia 
Foetida, Environ Sci Technol 2008; 42:3090-5. 
226 
227 
http://www.oecd.org/department/0,3355,en_2649_37015404_1_1_1_1_1,00.html  

http://www.irmm.jrc.ec.europa.eu/ 

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tests and therefore guidance has been developed on sample preparation and dosimetry for the 
safety testing of nanomaterials. The review mentioned here is consequently seen as a “living” 
document,  highlighting  the  feasibility  of  various  approaches  and  allowing  for  continuous 
updates,  given  the  rapid  developments  in  this  area.  The  outputs  of  European  and  other 
research  projects  were  combined  in  this  work  of  reviewing  test  guidelines;  preparing  the 
guidance for sample preparation and dosimetry of nanomaterials for various test systems; and 
providing guidance for the sponsorship programme. 

Because of the particular relevance of the inhalation route for exposure to nanomaterials, and 
the anticipated difficulties in assessing the effects of nanomaterials by this route, a document 
on  “Non-inhalation  exposure  methods  for  studies  on  the  pulmonary  toxicology  of 
nanoparticles”  was  produced  for  use  within  the  OECD  sponsorship  programme.  This  also 
included  results  of  in  vivo  tests  from  the  EU-funded  Nanosafe2  project.  This  document 
compares  currently  available  exposure  techniques  for  the  inhalation  route,  including  the 
advantages  and  limitations  of  inhalation  tests  and  intra-tracheal  instillation  tests,  from  the 
viewpoint of pulmonary toxicology. 

Current research on nanomaterial toxicity and associated mechanisms relies heavily on non-
validated alternative testing methods that are not always  used with  standardised  procedures. 
This  leads  to  considerable  uncertainties  in  the  research  results  and  their  comparability.  To 
address this problem, some research projects have developed standard operation procedures to 
ensure  wider  comparability  of  the  results  and  the  ongoing  work  in  the  OECD-WPMN 
supports these activities. 

Some of the test guidelines for degradation and accumulation are not applicable to the testing 
of nanomaterials, while others are applicable with limitations or under specific test conditions. 
General  guidance  documents  should  therefore  be  developed  for  testing  the  fate  and 
degradation of nanomaterials. It is also important to perform a detailed review of the OECD 
bioaccumulation methods. 

6.4.3.  Potential exposure throughout the life cycle 

The various projects on occupational, human health and environmental exposure have made 
substantial  contributions  to  guidelines  on  exposure  assessment  in  workplaces,  which  are 
compiled in a recently published OECD-WPMN document:228 

–  Comprehensive,  state-of-the-art  documents  with  recommendations  on  the  safe  handling 
and  use  of  manufactured  nanomaterials  and  exposure  control  measures  exist  (e.g.  ISO, 
BSI, ASTM), as well as guidance documents for measurement of exposure (parameters) or 
monitoring.  For  the  time  being,  these  documents  recommend  the  implementation  of  a 
precautionary  approach  in  the  manufacture  and  use  of  nanomaterials,  without  being  too 
restrictive. 

–  However,  more  specific  data  on  the  effectiveness  of  a  larger  variety  of  exposure  control 
measures  are  needed,  and  therefore  further  work  is  in  progress.  Data  should  be 
forthcoming in the near future from the many projects in this area. It is essential that the 
data  be  collected  and  reported  in  a  harmonised  manner,  in  order  to  optimise  their  use.  It 
should be realised, however, that exposures cannot currently be evaluated with respect to 
relevant  limit  values.  To  develop  a  more  science-based  guidance  or  regulations,  the 
following stepwise approach is recommended: 

228 
http://www.oecd.org/dataoecd/36/36/42594202.pdf  

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–  First,  “good  practices”  should  be  set  for  various  generic  tasks,  e.g.  transferring, 
mixing, filling, bag dumping, spraying, and so on. These might be either existing 
practices as acknowledged by experts, or mixtures of control measures considered 
to be practically achievable for theoretically defined exposure scenarios. 

–  Second,  comprehensive  descriptions  of  exposure  scenarios,  including  control 
measures,  should  be  documented.  Information  specific  to  particular  contexts 
should  be  made  available,  for  example  by  summarising  it  in  “fact  sheets”.  To 
characterise these good practice scenarios, the next step would be to collect data 
with  respect  to  exposure.  The  data  should  be  collected  using  harmonised  and 
appropriate  sampling  strategies  and  equipment,  allowing  their  interpretation  for 
various  exposure  metrics  and  exposure  measures.  Storage  in  a  database  should 
permit  future  analysis,  for  example  with  respect  to  the  effectiveness  of  control 
measures.  To  ensure  harmonised  storage  of  exposure  and  contextual  data,  a 
framework  should  be  developed  and  made  available  to  organisations  collecting 
this type of information. 

–  The  final  step  would  be  a  quantitative  benchmarking  of  the  good  practice 

scenarios against other scenarios for similar operational units. 

It is essential that future work on the possible exposure metric of surface area incorporate the 
surface chemistry. Future work on test filters and protective equipment should also focus on 
agglomerates. 

6.4.4.  Potential ecotoxicity, environmental fate and behaviour 

Many of the general factors described in the context of toxicity (sub-section 6.4.2 above) also 
apply to ecotoxicity. 

Research  work  has  so  far  focused  more  on  human  toxicity  than  ecotoxicity.  Practically  no 
work has been done on the issue of secondary toxicity. Methodological difficulties exist with 
regard  to  testing,  because  commercial  nanomaterials  often  present  significant  differentiation 
with  regard  to  their  labelled  properties,  leading  to  unreliable  and  irreproducible results. 
Moreover,  the  energy  dependent  uptake  and  the  intracellular  presence  of  nanoparticles  pose 
the question of bioaccumulation, which is becoming increasingly important. 

Regarding  the  verification  of  available  test  guidelines  for  ecotoxicity,  it  was  concluded  that 
the  guidance  on  preparation,  delivery,  measurement,  and  metrology  is  currently  inadequate 
for the testing of nanomaterials, although the basic ecotoxicological principles are applicable. 
On the other hand, the terminology used in the OECD test guidelines is not descriptive of, or 
specific to, the particulate or fibrous nature of nanomaterials. Terminology should be revised, 
both  to  make  it  more  specific  to  nanomaterials,  and  to  assure  that  test  outcomes  accurately 
reflect  the  potential  environmental  hazard  of  nanomaterials.  The  current  state  of  knowledge 
concerning nanomaterial ecotoxicity and possible exposure routes precludes making specific 
recommendations as to the development of new test guidelines. 

Local  effects,  such  as  local  nutrient  depletion or  shading  at  the  cellular  level,  are  important 
factors  in  ecotoxicity  test  systems,  in  need  of  further  investigation.  Furthermore,  current 
knowledge  on  specific  interactions  of  nanomaterials  within  water  is  still  limited,  especially 
with regard to humic acids, and therefore the currently obtained PNEC values (predicted no-
effect  concentrations)  are  to  be  considered  preliminary.  A  crucial  step  in  making  standard 
ecotoxicity test methods more reliable for nanomaterials is the collection of knowledge on the 
specific direct and indirect effects of nanomaterials. Hypothesis testing and the assessment of 
non-standard endpoints may play an important role in this process. In order to make progress 

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in closing knowledge gaps, there is the need to analyse different endpoints and consider the 
appearance of measurement artefacts and indirect effects. 

Work on the fate of nanomaterials in the environment and behavioural aspects has only just 
started and results from projects should be available in the next two years or so. An exception 
concerns  some  simulation  results  related  to  the  aqueous  environment,  which  confirmed  that 
the basic laws of colloidal science also apply to the stability of nanomaterials in suspensions 
and  showed  that  natural  organic  matter  stabilises  nanomaterial  suspensions  in  fresh  water. 
These  results  also  contributed  to  the  guidance  document  for  sample  preparation  and 
administration including dosimetry. 

6.4.5.  Life cycle assessment (LCA) of nanomaterials 

Life  cycle  assessment  is  needed  to  ensure  minimal  environmental  exposures,  ensure  that 
material loops are closed, and so on. LCA is a structured, internationally standardised method 
and  management  tool  for  quantifying  the  emissions,  resources  consumed,  as  well  as 
environmental  and  health  impacts,  which  are  associated  with  products  and  services.  LCA 
takes into account the product’s full life cycle, from the extraction of resources, production, 
consumption and recycling, up to the disposal of waste. 

The LCA process should also include economic, social and geographic aspects, as concluded 
at two different events, the Nanoforum Workshop229 and the joint EU-US LCA Workshop.230 
This would also allow a more complete analysis of sustainability, including for example the 
scarcity  of  raw  materials.  There  is  a  need  for  user-friendly  guidance,  including  approaches 
suitable to SMEs, for commercialising nanotechnologies. 

6.5. 

Research on health, safety and environmental issues – Further priorities from a 
regulatory perspective 

In the Communication on regulatory aspects of nanomaterials of 2008 and its accompanying 
Staff Working Document (see section 6.2 above), a thorough analysis of research needs was 
made  from  the  regulatory  perspective.  Since  then,  the  SCENIHR  and  the  Scientific 
Committee  of  EFSA  have  provided  their  opinions  on  potential  environmental,  health  and 
safety aspects of nanomaterials, and on what further research and developments are needed. 

It can be concluded from the results described in section 1.3 that European research, including 
that  funded  by  the  EU  Research  Framework  programmes  and  that  taking  place  at  the 
Commission’s JRC, has contributed substantially to the knowledge base on the potential risks 
of nanomaterials to the environment, human health and safety. This is especially the case in 
the  fields  of  nanomaterial  characterisation,  exposure  measurement  including  sampling 
strategies and mitigation, and hazard identification. 

However,  a  number  of  fundamental  knowledge  gaps  remain.  It  is  also  necessary  to  develop 
methods  further,  and  to  validate  and  harmonise  various  methodologies  for  characterisation, 
toxicity, ecotoxicity, exposure assessment and mitigation. Only then can the various guidance 
documents  and  implementing  regulations  for  the  safety  of  nanomaterials  be  updated  on  a 
sound  scientific  basis.  Without  validated  and  standardised  methodologies,  including  proper 

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http://www.nanoforum.org/nf06~modul~showmore~folder~99999~scid~483~.html?action=lon

gview_publication& 

ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/lca_nanotechnology_workshopoct2006_pr

oceedings_en.pdf 

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instrumentation, it is clearly impossible to ensure reliable and robust risk assessments of any 
substances – and nanomaterials are no exception to this basic rule. 

Based on the results obtained from earlier and current studies, the following work is needed in 
specific  areas  of  risk  assessment,  in  the  short-term  (up  to  4  years),  the  medium-term  (5-8 
years)  and  the  long-term  (9-11  years).  These  priorities  are  indicative  and  may  have  to  be 
reviewed in the future. 

6.5.1.  Measurement methods, reference materials and characterisation 

Short-term needs: 

–  To  generate  validated  and  harmonised  methodologies  (including  performance  criteria  for 
the  acceptance  of  test  results),  in  the  areas  of  characterisation,  exposure  assessment  and 
hazard identification. There has already been progress in the development, validation and 
harmonisation  of  reliable  methods  to  assess  relevant  properties  (size,  shape,  surface  area 
and  surface  chemistry);  particle  size  distribution;  and  physicochemical  and  biological 
parameters of nanomaterials in various matrices, biological and environmental media, and 
under various conditions. Also relevant are the definition of the metrics most appropriate 
for  hazard  characterisation  and  exposure  assessment,  and  the  development  of  reference 
nanomaterials.  It  should  finally  be  noted  that  several  characterisation  methodologies  are 
available but not yet validated and harmonised. 

–  To convey information on characterisation, exposure assessment and hazard identification 
methodologies  to  potential  end-users  and  boost  the  use  of  reference  materials  for  quality 
control,  calibration  and  validation  tools.  This  notes  the  progress  in  making  reference 
materials available (including certified reference materials), to underpin the development, 
validation and quality assurance of such methodologies. 

–  To address fundamental phenomena and biological interactions. Such results should inform 
the  work  on  toxicity  and  ecotoxicity,  as  well  as  the  development  of  reference  materials 
(and  studies  into  their  homogeneity  and  stability).  This  notes  the  progress  in  the  “basic” 
characterisation  of  nanomaterials  in  biological  and  environment  media  (with  regard  to 
particle  size,  surface  characteristics,  substances  on  particle  surface,  particle  charging, 
agglomeration, 
explosion 
kinetics, 
characteristics etc). 

de-agglomeration, 

formulation, 

solubility, 

Medium- to long-term needs: 

–  To develop more reference materials and certified reference materials, covering especially 
differences  in  shape  and  structure,  surface  area,  charge  and  surface  chemistry.  Suitable 
reference materials must be provided to relevant projects. Reproducibility is a crucial issue 
and  covers:  (i)  preparation  (especially  batch-to-batch  variations);  (ii)  dispersions  (e.g. 
without additives); and (iii) the stability of biological materials. In addition it is important 
to  ensure  that  the  reference  material  is  relevant  to  the  situation  being  tested  and  to  the 
material in commerce. In achieving this, a harmonised methodology should also be put in 
place, to ensure the comparability and subsequent acceptance of test results, as well as the 
reference materials themselves. 

–  To  develop  and  certify  test  aerosols  for  toxicity  studies.  The  relevant  requirements  for 
these, in addition to the primary nanomaterials characterisation, are: (i) to describe nano-
aerosol  characteristics  immediately  after  release  using  aerosol  dynamic  parameters  and 
models; (ii) to assess characteristics of “aged” nano-aerosols in the typical size range for 
auto-agglomeration  (20-200  nm),  and  the  typical  range  for  attachment  to  background 

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aerosol  (less  than  1  micrometre);  and  (iii)  to  study  the  toxicity  of  aged  nanoaerosols 
(homogeneous and heterogeneous agglomerates, and agglomerate stability). 

6.5.2.  Test methods for effects on human health 

In  this  area,  one  can  build  on  the  substantial  progress  made  in  the  context  of  the  OECD-
WPMN  sponsorship  programme.  This  includes  (i)  the  guidance  for  the  preparation  and 
administration of samples to test systems; and (ii) the conclusion that a number of available 
validated  test  methods  and  test  schemes  are  suitable  for  detecting  adverse  effects  of 
nanomaterials to human health, including acute and chronic toxicity. 

Short-term needs: 

–  To integrate the information already available into existing guidance documents and boost 

their application through awareness raising activities. 

–  To develop further, compare and validate in vitro, in vivo and in silico231 test methods and 
strategies, in order to speed up the adjustment of current test guidelines for nanomaterials 
and  to  enable  a  gradual  shift  towards  alternatives  to  animal  testing.  This  is  required  for 
existing as well as for new test methods and strategies. 

–  To  investigate  in  greater  detail  the  toxicokinetics,  metabolism  and  excretion  of 

nanomaterials, and their potential to cause adverse health effects. 

–  To  develop  an  approach,  including  the  calculation  of  mass  from  surface  area,  number 
concentration and size, allowing also for a link to historical data. To develop an approach 
for  the  building  up  of  a  toxicity  paradigm  between  adverse  short-  and  long-term 
toxicological  impacts  and  individual  or  combined  physicochemical  parameters,  such  as 
mass, surface area, number concentration and size, allowing also for the link to historical 
data. To ensure that information on both the approach and the toxicity data is effectively 
transferred to the expert communities on human and workplace exposure. 

–  To  perform  additional  studies  on  the  potential  hazards  of  nanofibres  and  nanotubes, 
building  on  the  recently  published  ones.  This  work  should  also  include  investigations  of 
the  influence  on  observed  effects  of  mechanical  or  chemical  means  to  suspend 
nanomaterials for testing. 

Medium- to long-term needs: 

–  To  further  develop,  harmonise  and  validate  alternatives  to  animal  testing  methods, 

including high throughput testing systems. 

–  To  carry  out  studies  on  a  range  of  endpoints,  assessing  and  quantifying  the  fate  of 
nanomaterials  in  the  body,  organs,  tissues  and  cells.  Additionally,  possible  intermediate 
deposition should be quantified. 

–  To  study  the  acute  and  chronic  impacts,  including  studies  on  potential  bioconcentration, 
bioaccumulation  or  persistence  of  various  nanomaterial  varieties.  Consequently,  suitable 
approaches are required to allow such an assessment. 

231 

In silico methods include databases, quantitative structure-activity relationships, and various molecular 
modelling  approaches,  machine  learning,  data  mining,  network  analysis  tools  and  data  analysis  tools 
that use a computer. In silico methods are primarily used alongside the generation of in vitro data both 
to create the model and to test it. 

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6.5.3.  Test methods for environmental effects 

In  this  area  also,  one  can  build  on  the  progress  already  made  in  the  context  of  the  OECD-
WPMN  sponsorship  programme.  This  includes  (i)  the  guidance  for  the  sample  preparation 
and dosimetry to test ecosystems; and (ii) the conclusion that a number of available validated 
test methods and test schemes are suitable, after ensuring a proper sample administration, for 
detecting  adverse  effects  from  nanomaterials  to  the  environment,  especially  related  to  their 
ecotoxicity, bioaccumulation, persistence and bioavailability. 

Short-term needs: 

–  To  integrate  the  information  already  available  in  existing  guidance  documents  and  boost 

their application through awareness raising activities. 

–  To develop further, compare and validate in vitro, in vivo and in silico test methods, and 
testing  strategies,  covering  also  degradation  and  accumulation,  in  order  to  speed  up  the 
adjustment of current test guidelines and to enable a gradual shift towards alternatives to 
animal testing. This is required for existing as well as for new test methods and strategies. 

–  To  investigate  further  effects,  including  the  underlining  mechanisms  of  actions  of 
nanomaterials and the affection of endpoints of nanomaterials related to their nano-specific 
reactions, when interacting with biological macromolecules and cellular structures, such as 
proteins  and  nucleic  acids  as  demonstrated  in  vitro  plus  the  classification  of  the  type  of 
tests. 

–  To develop an approach for the building up of a toxicity paradigm between adverse short- 
and  long-term  ecotoxicological  impacts  and  individual  combined  to  physicochemical 
factors such as mass, surface area, number concentration and size, allowing also for a link 
to historical data. To ensure that information on both the approach and the toxicity data is 
effectively transferred to the expert community on environmental exposure. 

Medium- to long-term needs: 

–  To develop, harmonise and validate alternatives to animal testing methods, including high-

throughput testing systems. 

–  To investigate further interactions in various environment media and species. 

–  To  develop  suitable  approaches  to  studying  the  acute  and  chronic  impacts  for  several 
varieties  of  nanomaterials,  including  potential  bioconcentration,  bioaccumulation  or 
persistence in the environment.  

6.5.4.  Exposure information throughout the life cycle 

Short-term needs: 

–  To  validate  and  harmonise  available  methodologies  related  to  spherical  shapes  of 
nanomaterials, and tackle the background issue as part  of an overall  monitoring  strategy. 
This  work  should  also  generate  qualitative  and  quantitative  performance  criteria  for  the 
development of future acceptance criteria for reliable tests including results. This should be 
based  on  progress  made  in  exposure  measurement,  sampling,  and  the  assessment  and 
correction of background. 

–  To  develop  further  a  testing  strategy  for  nanomaterials,  including  aerosols,  for  exposure 

assessment and for scenarios of primary release of nanomaterials in workplace air. 

–  To  finalise 

the  harmonisation  of  available  simulation  methodologies  (including 
performance criteria for the acceptance of test results); and ultimately to fine-tune these for 
different  applications,  materials,  uses  and  environmental  species.  This  priority  builds  on 

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the first generation of simulation methodologies, addressing coating stability in relation to 
worker exposure and skin penetration. 

–  To develop models with suitable sensitivity, which can predict residual concentrations of 
free  nanoparticles  from  release  rates;  and  to  implement  such  models  in  the  current  EU 
guidelines for environmental exposure assessment. These models should provide for robust 
extrapolation  and  also  make  allowances  for  the  implementation  of  existing  mitigation 
approaches. 

Medium- to long-term needs: 

–  To  develop  suitable  monitoring  approaches  and  equipment  for  personal  exposure.  These 
should  be  readily  applicable  to  existing  or  currently  developed  preparation  and 
manufacturing  techniques,  and  assess  the  effectiveness  of  personal  protection  equipment. 
This  work  should  also  include  the  development  of  harmonised  and  validated  analytical 
methods  to  detect  and  measure  ambient  concentrations  of  free  nanomaterials  in  various 
matrices. 

–  To  satisfy  the  requirements  in  the  previous  indent,  a  testing  strategy  is  needed  for 
nanomaterials  in  the  aerosol  phase,  including  various  shapes,  to  simulate  scenarios  of 
primary release of nanomaterials in workplace air. 

–  To  allow  for  an  effective  use  of  the  outputs  from  the  needs  summarised  above,  it  is 
essential to (i) develop and validate model aerosol sources for relevant classes of release 
mechanisms and species for use in toxicological studies; (ii) develop different test aerosols 
for toxicological studies; and (iii) develop new or refine existing aerosol dynamic models 
for predicting nanomaterial evolution including their validation, sensitivity testing. 

–  To  fine-tune  existing  simulation  methodologies  in  relation  to  product  stability  related  to 
worker exposure and skin penetration for other types or varieties of nanomaterials used in 
different  applications  and  modelling  other  uses  as  well  as  possible  effects  of  these  in 
various environmental compartments including species.  

–  To  develop  and  validate  real-time  sampling  and  measurement  approaches  for 
environmental and consumer exposure. These should allow an investigation of synergistic 
effects  of  mixed  exposures  and  exposures  from  re-used  and  recycled  products,  and  use 
various human and environmental biomarkers of exposure. 

6.5.5.  Life cycle Assessment (LCA) 

Short- to long-term needs: 

–  To further adjust,  validate  and  harmonise currently available  guidelines  for the  life cycle 
assessment  of  nanomaterials  and  nanotechnology-based  products,  building  upon  results 
from completed and ongoing activities. To develop hands-on guidance for simplified LCAs 
for SMEs. 

6.5.6.  Exposure mitigation 

Short-term needs: 

–  To  collect  information  on  existing  mitigation  approaches,  and  to  optimise  current 
approaches  to  safe  preparation  and  manufacturing,  by  also  boosting  their  application 
through awareness raising activities and uptake for future activities. 

–  To  further  refine  existing  mitigation  approaches,  by  building  on  existing  and  newly 

developed exposure models including available and newly generated data. 

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–  To  communicate  results  effectively,  in  order  to  boost  the  adoption  of  mitigation 

approaches in industry and by other relevant stakeholders. 

Medium- to long-term needs: 

–  To  improve  and  develop  new,  effective  and  economically  viable  waste  management, 
minimisation,  recycling,  handling,  treatment  and  disposal  technologies,  approaches  and 
tools for various nanomaterials and products containing these. 

–  To  develop 

inherently  safe  and  waste-free  manufacturing  processes  for  various 

nanomaterials. 

6.5.7.  Environmental fate 

Short-term needs: 

–  To  support  the  development  of  a  categorisation  of  nanomaterials  based  on  their 

environmental fate and behaviour. 

–  To  generate  information  to  develop  an  approach,  including  the  calculation  of  mass  from 

number concentration, surface area and size, allowing for a link to historical data. 

–  To  finalise 

the  harmonisation  of  available  simulation  methodologies  (including 
performance criteria for the acceptance of test results); and ultimately to fine-tune these for 
different applications, materials, uses and environmental species. This priority is built on 
the first generation of simulation methodologies addressing coating stability, in relation to 
end-of-life  assessment,  bioavailability,  bioaccumulation  and  fate,  and  the  distribution  of 
nanomaterials in aqueous environments. 

–  To perform a revision of the standard OECD methods for measuring solubility in water to 
accommodate  the  measurement  of  the  rate  of  dissolution  of  nanomaterials  in  the  natural 
environment.  

Medium- to long-term needs: 

–  To  develop  modelling  and  extrapolation  approaches  that  can  address  various  scenarios 

with appropriate sensitivity by building upon available methodologies and data. 

–  To  perform  studies  on  soil  systems,  marine  and  terrestrial  species  including  primary 
producers  and  combine  these  with  work  on  the  establishment  of  standard  protocols  for 
future testing. 

–  To assess the possible transfer of nanomaterials from environmental species into the food 
chain.  This  should  include  dietary  studies  and  an  assessment  of  the  role,  if  any,  of  the 
interaction of nanomaterials with the available amount of feed for various animal species 
in  different  environmental  compartments  and  other  environmental  contaminants.  This  is 
noting initial results pointing towards local shortage of feed for different animal species in 
the aqueous compartment.  

–  To  perform  specific  dietary  studies  assessing  the  role  of  functionalised  nanomaterials, 
which  are  consisting  of  coating  fragments,  since  such  fragments  may  have  a  substantial 
influence on the uptake and translocation of such functionalised nanomaterials within the 
body of different animals in various environmental compartments. 

A longer-term objective in all areas of risk assessment above is to extend the work to various 
nano-objects,  especially  “active”  nanomaterials,  which  are  still  in  the  embryonic  research 
phase.  Although  such  nanomaterials  are  still  in  the  research  phase,  this  will  facilitate  the 
progress  from  “reactive”  research  on  environmental,  health  and  safety  issues  towards 
“anticipatory” research. Moreover, it is demonstrating the implementation of the “integrated, 

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safe  and  responsible”  principle  for  the  development  of  nanotechnologies  by  equally 
contributing to their future societal acceptance. 

6.5.8.  Networking and Infrastructure 

Progress  has  already  been  made  in  the  networking  of  existing  infrastructures,  and  the 
establishment of new networks, to ensure a cost-effective and efficient examination of health, 
safety, and environmental aspects of nanomaterials throughout Europe. 

Short-term needs: 

–  To  enhance  current  networks  and  infrastructures  of  different  types,  to  make  them  more 

effective and efficient. 

Medium- to long-term needs: 

–  To establish effective links between different networks and infrastructures in Europe, and 

also with relevant activities worldwide. 

–  To effectively connect research networks active on medical applications of nanomaterials 
with  the  networks  active  on  environmental,  health  and  safety  research.  This  will  also 
facilitate the progress from “reactive” research on environmental, health and safety issues 
towards “anticipatory” research. 

6.5.9. 

Strategic and Structural Development Needs 

–  It  is  essential  to  capitalise  on  the  results  already  available  and  arising  from  current 
methodologies  and  their  further  development,  as  described  in  section  1.3.  Nevertheless, 
their validation and harmonisation should now be accelerated. 

–  Many promising but non-validated alternative methods to animal testing exist and are used 
for mechanistic studies of nanomaterial toxicity. However, their acceptance in the ECVAM 
validation  process  and  their  development  into  high-throughput  testing  processes  requires 
further research, as well as the development and validation of standardised protocols. 

–  Environmental, health and safety research needs to be expanded, to match the production 

and marketing of new materials and applications of nanotechnology. 

–  A  distinction  should  be  made  between  innovative  environmental,  safety  and  health 
research  on  the  one  hand,  and  the  collection  of  reference  data  and  routine  testing  by 
industry  and  competent  authorities  on  the  other  hand.  Clearly,  Research  Framework 
Programme resources have to be used for breakthrough innovation – proposals that are not 
sufficiently innovative do not score high enough in the evaluation to be funded, no matter 
how important they may be. 

–  As  the  proper  application  of  risk  assessment  and  Life  cycle  Assessment  (LCA)  requires 
reliable and generally agreed databases, a mechanism should be established to use existing 
or  establish  new  ones  and  adequately  populate  those.  This  need  cannot  be  covered  by 
bibliographic databases. The issues are how such data can be anonymised, aggregated and 
made publicly available; and how such a mechanism could benefit from proprietary data. 
Various  approaches  for  anonymising  and  aggregating  data  are  available  and  should  be 
employed to the maximum possible extent.  

–  Particular  focus  should  be  given  to  the  activities  of  OECD-WPMN  and  ISO,  to  further 
develop  and  validate  test  methods  and  standards.  Regulation  requires  internationally 
harmonised  and  validated  standards  and  methodologies.  The  active  contribution  of  the 
Commission  to  this  work  is  therefore  essential.  This  work  has  been  instrumental  and 
should continue. 

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–  Cooperation  with  Member  States  and  international  partners  should  continue,  as  it  is 
essential in prioritising research needs, boosting synergies and using resources efficiently. 

–  Greater  transparency  about  research  and  research  results  is  needed.  Research  projects 

funded by public money should generate publicly available data. 

–  In accordance with the “integrated, safe and responsible” principle for the development of 
nanotechnologies,  and  the  Commission’s  Code  of  Conduct,  EU-funded  research  should 
integrate safety aspects at the earliest possible stage in the development of applications and 
new  “active”  nanomaterials.  This  will  facilitate  the  progress  from  “reactive”  research  on 
environmental, health and safety issues towards “anticipatory” research. 

6.6. 

International cooperation – developing a common base of knowledge 

The challenge of filling knowledge gaps calls for international collaboration, coordination and 
the sharing of information. There is also a need to obtain internationally harmonised standards 
and  methods,  building  on  the  availability  of  various  candidate  methodologies.  In  particular, 
the OECD, ISO and CEN have become key forums in the generation of formally recognised 
methodologies in areas relevant to legislation. In the OECD, formally recognised test methods 
and test guidelines are being developed and work on exposure has been initiated. In ISO and 
CEN,  work  on  formal  standards  and  nomenclature  is  ongoing  and  the  first  terminology 
definitions  have  been  released.232  The  European  Commission  and  EU  Member  States  put 
significant resources into these activities. 

Collaboration  with  international  partners  within  EU-funded  research  projects  is  actively 
supported  and  several  projects  have  partners  outside  the  EU.  Coordinated  calls  are  also 
organised  with  other  countries,  like  the  US.  This  collaboration  extends  to  research  on  risk 
assessment. 

6.6.1.  OECD Working Party on Manufactured Nanomaterials (WPMN) 

In Europe most test guidelines applicable under EU regulations are based on the work of the 
OECD.  In  2006  the  OECD  established  the  Working  Party  on  Manufactured  Nanomaterials 
(WPMN), to promote international cooperation in the health, safety and environmental issues 
of  manufactured  nanomaterials.  This  is  the  main  forum  for  international  cooperation  in  this 
area, for example in the development of test methods needed for the proper implementation of 
regulation. 

The Working Party is implementing its work through eight specific projects to further develop 
appropriate methods and strategies: 

1. Development of a Database on Human Health and Environmental Safety Research; 

2. Research Strategies on Manufactured Nanomaterials; 

3. Safety Testing of a Representative Set of Manufactured Nanomaterials; 

4. Manufactured Nanomaterials and Test Guidelines; 

5. Co-operation on Voluntary Schemes and Regulatory Programmes; 

6. Co-operation on Risk Assessment; 

7. The role of Alternative Methods in Nanotoxicology; and 

8. Exposure Measurement and Exposure Mitigation. 

232 

CEN ISO/TS 27687:2008 

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A flagship activity is the so-called “sponsorship programme”,233 launched in November 2007: 
This  pools  resources  from  all  the  OECD  Member  countries  and  involved  industries  in  an 
effort to perform tests on an agreed priority list of 14 commercially relevant nanomaterials on 
59  different  endpoints.234  The  outcome  of  this  programme  is  expected  in  the  years  to  come 
and will serve as a very significant resource supporting the implementation of enhanced safety 
requirements.  A  key  condition  is  to  make  tests  comparable,  given  the  involvement  of  many 
independent  research  institutions.  For  nanomaterials  this  is  a  significant  challenge,  as 
reference nanomaterials, measurement and dosimetry are still under continuous development. 
The  OECD  has  acknowledged  these  shortfalls  and  developed  a  “Guidance  manual  for 
sponsors”;235  and  guidance  for  sample  preparation  and  dosimetry,  which  is  being  finalised. 
There  is  a  close  collaboration  with  the  standardisation  work  of  ISO.  The  programme  will 
serve the following purposes: 

–  It will generate data about the 14 nanomaterials on 59 endpoints. 

–  It will assess the applicability of currently available test guidelines to nanomaterials. 

–  It  will  help  to  identify  any  new  intrinsic  property  and  thereby  the  need  for  new  test 

methods. 

–  It will generate knowledge about alternatives to animal testing methods. 

Testing  strategies  used  in  the  Sponsorship  Programme  should  primarily  focus  on  the 
endpoints presented in the sponsorship guidance  manual,  and  make  best  use  of  existing  test 
methods  (OECD  test  guidelines,  ISO  standards  or  equivalent).  The  sponsorship  programme 
requests  that  the  special  characteristics  of  nanomaterials  and  their  potential  impacts  at  the 
cellular  level  should  be  taken  into  account.  Specific  attention  should  also  be  paid  to  tests 
which provide mechanistic information and information on metabolic pathways. 

A  specific  focus  is  also  given  in  the  sponsorship  programme  to  the  development  of  non-
animal  and  alternative  methods.  A  specific  steering  group  is  focusing  on  alternative  test 
methods  and  test  strategies  and  their  validation.  A  report  presented  to  the  WPMN  in  2008 
addressed  the  role  of  alternative  methods,  prioritisation  schemes  for  test  method  selection, 
quality and good laboratory practice, validation and testing strategies. At this stage, however, 
it is not possible to make recommendations as to specific alternative approaches to be used for 
testing nanomaterials. It is not clear how information generated through alternative methods 
can  be  used  (including  the  identification  of  unforeseen  target  organs  and  knowledge  of 
biological mechanisms of action). 

Turning  to  exposure  to  nanomaterials,  the  Steering  Group  on  exposure  assessment  and 
mitigation (SG8) started its work recently, and five documents have been published so far:236 

–  “Report  of  an  OECD  Workshop  on  Exposure  Assessment  and  Exposure  Mitigation: 

Manufactured Nanomaterials” 

233 
Details on the OECD-WPMN Sponsorship Programme can be found on 
http://www.oecd.org/document/47/0,3343,en_2649_37015404_41197295_1_1_1_1,00.html 
234 
http://www.olis.oecd.org/olis/2008doc.nsf/linkto/env-jm-mono(2008)13-rev 
235 
This  guidance can  be downloaded  together with  other related  documents  from  the  following  website: 
http://www.oecd.org/findDocument/0,3354,en_2649_37015404_1_119663_1_1_1,00.html 
All of these reports can be downloaded from the following websites: 

236 
http://www.oecd.org/findDocument/0,3354,en_2649_37015404_1_119820_1_1_1,00.html 
http://www.oecd.org/findDocument/0,3354,en_2649_37015404_1_119666_1_1_1,00.html 
http://www.oecd.org/department/0,3355,en_2649_37015404_1_1_1_1_1,00.html 
http://www.oecd.org/document/53/0,3343,en_2649_37015404_37760309_1_1_1_1,00.html 

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–  “Identification,  Compilation  and  Analysis  of  Guidance  Information  for  Exposure 

Measurement and Exposure Mitigation: Manufactured Nanomaterials” 

–  “Emission Assessment for Identification of Sources and Release of Airborne Manufactured 

Nanomaterials in the Workplace: Compilation of Existing Guidance” 

–  “Comparison of Guidance on Selection of Skin Protective Equipment and Respirators for 

Nanotechnology Workplace: Manufactured Nanomaterials”; and 

–  “Preliminary Analysis of Exposure Measurement and Exposure Mitigation in Occupational 

Settings: Manufactured Nanomaterials”. 

Currently,  SG8  works  on  a  compilation  of  laboratory  guidance,  and  started  discussions  on 
activities related to environmental and consumer exposure. 

As  regards  the  risk  assessment  methodologies,  the  report  on  the  current  situation  is  being 
finalised, as well as the report from the workshop of the Steering Group on Risk Assessment 
(SG6),  including  case  studies  on  nano-silver,  titanium  dioxide  and  carbon  nanotubes.  The 
OECD-WPMN also assessed the situation in the voluntary reporting regimes in its Member 
Countries;  and  established  a  database  on  research  projects  on  the  HSE  issues  of 
nanomaterials.237 

6.6.2. 

International Organization for Standardization (ISO) 

The  activities  of  the  nanotechnology-related  Technical  Committees  in  ISO  (TC 229)  and  in 
CEN  (TC 352)  were  presented  in  sub-section  4.4.3.  Of  the  forty  documents  developed  by 
ISO/TC 229, the two that have already been published are relevant to the regulatory aspect. In 
2008,  a  first  CEN/ISO  Technical  Specification  was  released,238  defining  such  terms  as 
nanoscale, nanoparticle, nano-object and nanotube. This document now sets an internationally 
agreed  set  of  important,  fundamental  definitions  for  the  area  of  nanomaterials.  The  second 
published  document  is  an  informative  technical  report  on  health  and  safety  practices  in 
occupational  settings  relevant  to  nanotechnologies.239  Among  the  other  documents  being 
developed  in  ISO/TC 229,  about  ten  are  related  to  the  terminologies  of  different 
nanotechnology  domains.240  The  Commission  (mainly  the  Joint  Research  Centre)  is  closely 
following the work in ISO and CEN. 

In  addition,  ISO/TC  146  released  a  technical  report  on  inhalation  exposure  characterisation 
and assessment of ultra fine and nanostructured aerosols in workplace atmospheres.241 And in 
the particle characterisation group in ISO/TC 24/SC 4, the particular issue of nanoparticle size 
measurements and the required reference materials is considered.242 

In  the  international  metrology  and  pre-normative  arenas,  collaborative  organisations  have 
been set up between EU partners and non-EU countries, as described in sub-section 4.4.5. An 
example  is  VAMAS,  the  Versailles  project  on  Advanced  Materials  and  Standards,  which 
feeds the outcome of its research into the ISO standardisation process. 

237 
238 
239 
240

241 
242 

http://www.oecd.org/document/26/0,3343,en_2649_37015404_42464730_1_1_1_1,00.html  
CEN ISO/TS 27687:2008 
ISO/TR 12885:2008 

http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_co

mmittees/iso_technical_committee.htm?commid=381983 
ISO/TR 27628:2007 
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=47166 

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ISO has also received a number of important recommendations from a workshop in February 
2008243 and these are now being pursued: 

–  enhance  the  development,  efficacy,  harmonisation  and  uptake  of  documentary  standards 
broadly relevant to the field of measurement and characterisation for nanotechnologies; 

–  identify good practice and guidance documents covering the suitability and limitations of 

measurement and characterisation techniques for use with nanomaterials; 

–  ensure a greater dissemination, verification and validation of handling and testing protocols 

and related procedures by the broader community; and 

–  ensure  that,  in  the  area  of  nanomaterials  characterisation,  there  is  sufficient  clarity  in  the 
identification  of  measurands  related  to  several  materials  properties,  including  those 
corresponding to endpoints addressed by the OECD-WPMN Sponsorship Programme. 

6.6.3.  Cooperation on Implementation of Regulation 

As  described  above,  the  main  forum  for  international  cooperation  on  the  implementation  of 
regulation  is  the  OECD.  The  world  community  also  works  together  within  ISO,  where  in 
particular work on terminology will create a basis for a convergent approach in regulation and 
implementation world-wide. 

In  addition,  nanotechnology  and  nanomaterials  remain  standing  issues  on  the  agendas  of 
international  forums.  In  particular  there  is  a  regulatory  dialogue  with  countries  such  as  the 
US,  Canada,  Australia  and  Japan.  Several  meetings  took  place  between  these  countries  on 
achieving a convergent approach towards meeting regulatory requirements, with a particular 
emphasis  on  the  sectors  of  food,  cosmetic  products,  pharmaceuticals  and  medical  devices. 
Sectoral  regulatory  cooperation  with  various  trading  partners  has  been  established  for 
cosmetics (ICCR244), pharmaceuticals (ICH245) and medical devices (GHTF246). 

Attention is also drawn to a project entitled “Regulating Nanotechnologies in the EU and US: 
towards effectiveness and convergence”.247 This benefited from a grant by the Commission, 
and was implemented by the London School of Economics and Political Sciences, Chatham 
House, Environmental Law Institute and The Project on Emerging Nanotechnologies. Its final 
report  was  presented  in  September  2009,  in  a  series  of  conferences  with  stakeholders  and 
authorities from US and Europe. 

UNGHS is responsible for the global harmonised system for the classification, labelling and 
packaging  of  chemicals,  including  nanomaterials.  Discussions  on  nanomaterials  have  been 
initiated  in  one  of  the  expert  committees.  The  group  has  however  decided  to  await  results 
from the OECD-WPMN before carrying out further work. 

The Strategic Approach to International Chemicals Management (SAICM) is a broad policy 
framework  for  chemicals  management  programmes  under  a  voluntary  UN  process. In  its 

243 

ISO,  IEC,  NIST  and  OECD  International  Workshop  on  documentary  standards  for  measurement  and 
characterisation for nanotechnologies, NIST, Gaithersburg, Maryland, USA, 26-28 February 2008” 

http://www.standardsinfo.net/info/livelink/fetch/2000/148478/7746082/assets/final_report.pdf 
http://www.oecd.org/findDocument/0,3354,en_2649_37015404_1_119808_1_1_1,00.html 
244 
245 

International Cooperation on Cosmetics Regulation 
International  Conference  on  Harmonisation  of  Technical  Requirements  for  Registration  of 
Pharmaceuticals for Human Use 
Global Harmonisation Task Force (for medical device regulation) 

246 
247

EN 

http://www2.lse.ac.uk/internationalRelations/centresandunits/regulatingnanotechnologies/nano

home.aspx 

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second  conference  in  May  2009,  SAICM  identified  nanotechnology  and  manufactured 
nanomaterials as an emerging policy issue. Although duplication of efforts should be avoided, 
SAICM  can  provide  an  overarching  frame  in  the  long  term  and  will  reach  a  much  broader 
group  than  the  OECD  (worldwide  governments,  industry  and  the  NGO  sector).  The 
conference concluded that SAICM should focus on information exchange and on facilitating 
access  to  relevant  information  on  nanotechnologies  and  manufactured  nanomaterials, 
especially by different stakeholders in developing countries and countries with economies in 
transition. For example, REACH, in its Articles 118-120, provides detailed help and guidance 
on the exchange of data and information on HSE aspects. 

7. 

INTERNATIONAL COOPERATION 

A  proper  and  efficient  approach  to  nanotechnology  and  nanomaterials  must  take  into 
consideration  the  international  dimension,  in  terms  of  R&D,  access  to  information  and 
regulation.  International  cooperation,  including  collaboration  in  research  but  not  limited  to 
this,  is  now  an  integral  part  of  the  Commission’s  policy  in  all  areas  of  the  Action  Plan. 
Throughout  this  staff  working  document,  reference  has  therefore  been  made  to  work  at  the 
international level, and the following is meant as a summary of headings only: 

–  Collaboration in research (section 1.6), including research on HSE issues (section 1.3) 

–  The  Third  International  Dialogue 
nanotechnology (sub-section 1.6.3) 

in  2008  on 

the  responsible  development  of 

–  Cooperation on regulatory aspects, mainly but not exclusively through the OECD-WPMN 

(sub-section 6.6.1) 

–  Contribution  to  international  standards,  through  ISO  (section  4.4),  including  the  area  of 

risk assessment (sub-section 6.6.2) 

–  Participation  in  the  work  of  OECD-WPN  on  the  governance  of  nanotechnology  (section 

4.5) 

–  Access to data and research results (sections 1.6 and 6.6) 

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Annex  1:  Degree  of  fulfilment  of  Commission  Actions  in  Nanotechnology  Action  Plan 

2005-2009 

The following table gives an assessment, necessarily subjective, of the degree of fulfilment of 
each  one  of  the  goals  identified  for  Commission  action  in  the  Nanotechnology  Action  Plan 
2005-2009 (the original text for each goal is reproduced). The ratings given are: 3 – complete 
fulfilment, which does not preclude future work in this area; 2 – partial fulfilment, although 
much work has been carried out; 1 – relatively little progress. 

1. RESEARCH, DEVELOPMENT AND INNOVATION: EUROPE NEEDS 
KNOWLEDGE 

a) Reinforce N&N R&D in the European Union’s seventh framework programme 
for research, technological development and demonstration activities (FP7), and 
has proposed a doubling of the budget compared to FP6. Interdisciplinary R&D 
should  be  strengthened  along  the  entire  chain  for  knowledge  creation,  transfer, 
production and use; 

b) Propose specific support to research in nanoelectronics under the Information 
and Communication Technology (ICT) priority of FP7. In line with the research 
agenda  of  the  European  Technology  Platform  on  Nanoelectronics,  this  will 
stimulate industrially-relevant research in a technologically mature field, provide 
the  foundation  for  the next  generation of  electronics  and enable  many  new  ICT 
applications, whilst drawing on complementary research in other thematic areas; 

c)  Boost  support  for  collaborative  R&D  into  the  potential  impact  of  N&N,  in 
particular engineered nanoscale entities (e.g. nanoparticles), on human health and 
the  environment  via  toxicological  and  ecotoxicological  studies  as  well  as 
developing  appropriate  methodologies  and  instrumentation  for  monitoring  and 
minimising  exposure  in  the  workplace,  including  portable  in  situ  measuring 
devices10; 

d)  Foster  the  development  of  European  Technology  Platforms  in  order  to 
implement  a  strategic  R&D  agenda  for  N&N  sectors  that  are  important  for 
Europe’s  competitiveness  e.g.  in  nanomedicine,  sustainable  chemistry  or  space 
(including the possibility of launching European Technological Initiatives). 

2. INFRASTRUCTURE AND EUROPEAN POLES OF EXCELLENCE  

a) Establish a map of existing European N&N infrastructure and explore ways of 
maximising  its  added  value  by  the  exchange  of  best  practice.  Special  attention 
will  be  paid  to  the  needs  of  industry,  in  particular,  small  and  medium  sized 
enterprises (SMEs) so to reinforce cooperation with and technology transfer from 
academic  R&D  teams  to  conceive  advanced  prototypes  and  validate  them  in 
industrially relevant environments; 

b)  Support  transnational  networking  and  integration  of  resources  across 
universities,  R&D  organisations  and  industry  as  a  means  of  assembling  critical 
mass  through  ‘distributed’  poles  of  excellence  e.g.  via  the  Networks  of 
Excellence and Integrated Infrastructure Initiatives instruments under FP6. Some 
areas  of  N&N  R&D  would  particularly  benefit  from  such  integration  include 
nanotoxicology  and  nanoecotoxicology,  as  well  as  nanometrology  that  would 
support EU competitiveness in this field. 

3.  INTERDISCIPLINARY  HUMAN  RESOURCES:  EUROPE  NEEDS 
CREATIVITY  

a) Promote networking and disseminate best practices for education and training 

3 

3 

2 

3 

2 

2 

2 

EN 

100 

   EN 

 
 
 
 
in N&N. A dedicated workshop is taking place in 2005 and the proceedings will 
be widely disseminated; 

b)  Explore  how  to  best  encourage  the  development  of  relevant  supporting 
activities  (e.g.  cross-border  thematic  networks  and  other  actions),  in  particular 
through  its  programmes  and  specifically  the  proposed  new  generation  of 
education and training programmes after 2006; 

2 

c)  Promote  the  creation  of  an  ‘interdisciplinary  European  award  in  N&N’  that 
recognises scientific advances and entrepreneurship and/or progress in the area of 
safety and the environment, in line with the integrated and responsible approach. 
Sponsorship from industry and other interested organisations will be sought; 

d)  Explore  the  possibility  for  dedicated  N&N  ‘Marie  Curie’  actions  (e.g. 
fellowships)  that  stimulate  transnational  doctorate-level  programmes.  Lifelong 
learning for researchers and engineers will also be promoted by actions aimed at 
disciplinary  and/or  sectorial  mobility.  Special  attention  will  be  paid  to  the 
participation of women and duly rewarding the hosting institutions. 

4.  INDUSTRIAL  INNOVATION:  FROM  KNOWLEDGE  TO  THE 
MARKET 

a)  Foster  the  industrial  exploitation  of  R&D  N&N  by  bringing  together 
stakeholders  to  exchange  best  practice  for  the  commercialisation  of  N&N. 
Special attention will be paid to the societal, political and psychological barriers 
to entrepreneurship in Europe e.g. the stigma of failure, as well as how to better 
facilitate  agreement  upon  licensing  arrangements  between  industry  and  R&D 
organisations  /  universities  e.g.  the  ‘Berliner  Vertrag’  or  the  Responsible 
Partnering Initiative; 

Specific action deemed 
unnecessary, since 
nanosciences and 
nanotechnologies are taking 
an adequate share of generic 
activities 

1 

b)  Increase  the  industrial  involvement  in  collaborative  EU  R&D  projects  for 
N&N as a means of promoting the transformation of traditional industries as well 
as the growth of knowledge-intensive SMEs and ‘start ups’. Means of providing 
support  for  smaller  prototype/demonstration  projects  at  EU-level  will  be 
explored; 

3 (2 with regard to 
demonstration projects) 

c)  Support  the  creation  of  a  web-based  ‘Digital  N&N  Library’  to  analyse  the 
diverse landscape of N&N in Europe and to draw together data from a wide range 
of  sources  e.g.  publications,  patents,  companies,  market  data,  R&D  projects, 
organisations; 

d)  Support  pre-normative  R&D  for  N&N  in  synergy  with  the  activities  of 
European  Standards  Bodies.  It  will  in  particular  invite  proposals  for  Specific 
Support Actions for ‘nanometrology’ in FP6; 

3248 

1249 

e)  Support  the  establishment  of  a  N&N  Patent  Monitoring  System  e.g.  by  the 
European  Patent  Office  (EPO)  as  well  as  the  harmonisation  of  practices  in  the 
processing of N&N patent applications between patent offices such as the EPO, 
United  States  Patent  and  Trademark  Office  (USPTO)  and  Japan  Patent  Office 
(JPO). 

1 (2 with regard to 
monitoring, e.g. OECD) 

5.  INTEGRATING  THE  SOCIETAL  DIMENSION:  ADDRESSING 
EXPECTATIONS AND CONCERNS 

248 
249 

Work of ICPC NanoNet and ObservatoryNANO projects 
The Nanostrand project carried out a fact finding mission, however, pre- and co-normative research is 
yet to be funded, as is pointed out in the report of CEN on the programming mandate. 

EN 

101 

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a) Ensure that Community funded R&D in N&N continues to be carried out in a 
responsible manner e.g. via the use of ethical reviews. Possible ethical issues for 
N&N include e.g. non-therapeutic human enhancement, invasion of privacy due 
to invisible sensors. The integration of ethical concerns, innovation research and 
social  sciences  into  N&N  R&D  will  help  build  confidence  in  decision-making 
related to the governance of N&N; 

b) Ask the European Group on Ethics in Science and New Technologies to carry 
out  an  ethical  analysis  of  nanomedicine.  This  will  identify  the  primary  ethical 
concerns and enable future ethical reviews of proposed N&N R&D projects to be 
carried out appropriately; 

c)  Support  studies  and  foresight  activities  into  future  N&N  scenarios  so  to 
provide  useful  information  about  the  possible  risks  to,  and  potential  impact  on, 
society. In the area of nanobiotechnology, synergy can be developed with a study 
that  is  being  undertaken  by  the  Commission  at  the  request  of  the  European 
Parliament  to  assess  and  conduct  a  cost-benefit  analysis  of  biotechnology  and 
genetic engineering; 

d)  Create  the  conditions  for  and  pursue  a  true  dialogue  with  the  stakeholders 
concerning  N&N.  In  support  of  this  dialogue,  special  Eurobarometer  (EB) 
surveys  should  study  the  awareness  of  and  attitudes  towards  N&N  across 
Member  States.  This  will  allow  an  assessment  of  the  effectiveness  of  different 
approaches  across  Europe  as  well  as  providing  ‘early  warning’  of  particular 
concerns; 

e)  Produce  multilingual  information  material  to  raise  awareness  of  N&N  for 
different age groups building upon the success of pilot initiatives that have been 
launched by the Commission including films, brochures and other internet-based 
material; 

6.  PUBLIC  HEALTH,  SAFETY,  ENVIRONMENTAL  AND  CONSUMER 
PROTECTION 

a)  Identify  and  address  safety  concerns  associated  with  applications  and  use  of 
N&N  at  the  earliest  possible  stage.  The  Scientific  Committee  on  Emerging  and 
Newly  Identified  Health  Risks  has  been  requested  to  provide  an  opinion  on  the 
appropriateness of existing methodologies to assess the potential risks associated 
with engineered and adventitious products of N&N; 

b)  Promote  safe  and  cost-effective  measures  to  minimise  exposure  of  workers, 
consumers  and  the  environment  to  manufactured  nanoscale  entities.  It  will  also 
support a wide range of studies (including epidemiological studies) to (i) evaluate 
current  and  future  projected  levels  of  exposure,  (ii)  evaluate  the  adequacy  of 
current  approaches  to  control  exposure  and  (iii)  launch  appropriate  initiatives, 
propose  measures  and/or  issue  recommendations;  20  See  Treaty  Articles  152 
(health), 153 (consumers), and 174 (environment) 21 See Point 22 of Chapter 9 
(p.  82)  of  the  2004  Report  by  UK  Royal  Society  and  the  Royal  Academy  of 
and 
Engineering 
uncertainties” 

nanotechnologies: 

“Nanoscience 

opportunities 

and 

c) Develop with Member States, international organisations, European agencies, 
industry  and  other  stakeholders,  terminology,  guidelines,  models  and  standards 
for  risk  assessment  throughout  the  whole  life  cycle  of  N&N  products.  Where 
appropriate, risk assessment and management procedures will need to be adapted 
accordingly to ensure a high level of protection; 

d)  Examine  and,  where  appropriate,  propose  adaptations  of  EU  regulations  in 
relevant  sectors  in  light  of  the  above  paying  particular,  but  not  exclusive, 

3 

3 

2 

2 

3 

2 

1 

2 

2 

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attention to (i) toxicity thresholds, (ii) measurement and emission thresholds, (iii) 
labelling  requirements,  (iv)  risk  assessment  and  exposure  thresholds  and  (v) 
production and import thresholds, below which a substance may be exempt from 
regulation, are typically based upon mass quantities. 

7. INTERNATIONAL COOPERATION  

a) Intensify dialogue at international level with a view to adopting a declaration 
or  a  ‘code  of  good  conduct’  for  the  responsible  development  and  use  of  N&N. 
Industry shall be invited to adhere to these principles; 

2 (3 at EU level) 

b)  Address  issues  of  mutual  benefit  at  global  level  e.g.  on  nomenclature, 
metrology,  common  approaches  to  risk  assessment  and  the  establishment  of  a 
dedicated  database  to  share  toxicological  and  ecotoxicological  as  well  as 
epidemiological data; 

c) Support the creation of a free and open European electronic archive of N&N 
scientific  and  technical  publications  according  to  the  principles  set  out  in  the 
OECD Declaration on Access to Research Data from Public Funding. 

8.  IMPLEMENTING  A  COHERENT  AND  VISIBLE  STRATEGY  AT 
EUROPEAN-LEVEL 

a)  Monitoring  and  overseeing  the  implementation  of  this  Action  Plan,  its 
conformity  and  coherence  with  Commission  policies  (e.g.  R&D,  education  and 
training,  employment,  enterprise  policies,  health  and  consumer  protection), 
related  initiatives  throughout  the  Union  and  other  relevant  activities  (e.g.  the 
Commission’s  Biotechnology  Steering  Committee),  so  to  ensure  maximum 
effectiveness; 

b)  Reporting  on  progress  made  with  the  Action  Plan  every  two  years  to  the 
Council and the European Parliament, making use of indicators, where possible. 
A revision of the Action Plan, if necessary, shall be envisaged; 

c)  Performing  a  range  of  activities  so  to  accompany  and  foster  a  useful, 
beneficial, profitable and consensual exploitation and application of N&N in the 
EU  e.g.  via  dedicated  ‘horizon  scanning’  activities,  pro-active  and  responsive 
dialogue with the public and ad-hoc initiatives at international level. 

2-3 

3 

3 

3 

2250 

250 

Some activities have been carried out, including sectoral innovation foresight. HSE activities led to a 
substantial concentration of nanotechnology applications mainly in health, electronics & energy fields. 
However, a real enhancement of exploitation and application has not been achieved. 

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Annex 2: Nanomaterials on the market  

Stages  that  describe  the  readiness  of  nanotechnology  solutions  for  the  market  can  be  characterized  as  (1) 
scientific discovery; (2) laboratory prototype; (3) industrial demonstration (pilot-line scale); (4) introduction to 
industrialisation  (normal  plant  level);  and  (5)  scaling  up  to  mass  production.  The  volumes  of  nanomaterials 
produced and handled vary considerably in each stage, and influence the assessment of potential exposure and 
potential impacts of nanomaterials to human health and the environment. 

This  table  concerns  stages  (4)  and  (5)  above,  which  are  indicated  by  (I)  and  (S),  respectively.  It  refers  to 
materials effectively on the market. 

Ae:  aerospace;  Au:  automotive;  Co:  construction;  El:  electronics;  EE:  energy  and  environment; 
Mnf: manufacturing; Med: medical and pharmaceutical; OG: oil and gas. 

LuxResearch, 2009 and 2008; NanoRoadSME, 2008; and ObservatoryNANO, 2009 

Nanomaterial 

Description 

Examples of applications in use in the core sectors 

Ceramic 
nanoparticles 

Metal oxides (e.g. titanium 
dioxide, zinc oxide, iron 
oxide, etc) 

Metal sulphides and 
nitrides, and other 
inorganic compounds 

All can be coated with 
layers of polymers, 
surfactants, or other 
inorganic materials 

Metal nanoparticles   Metal nanoparticles are 
most commonly silver, 
gold, aluminium or nickel 

Nanoporous 
materials 

Carbon nanotubes 

Materials (e.g. silicon 
dioxide, carbon, 
aluminium oxide, various 
polymers, metals and 
silicon) with pores of 0-
100 nm  

Single-walled nanotubes 
(SWNTs), generally about 
1 nm in diameter 

Multi-walled nanotubes 
(MWNTs), diameter 5-100 

Ae: Metal and composite coatings with ceramic nanoparticles for 
aerodynamic surface (I). Au: Cerium oxide NPs for fuel 
additives to increase fuel efficiency (I). Au: NP-coated interior 
parts to stand extreme heat and pressure (I). Au: NPs to enhance 
appearance and protect exterior (I). Au: Ceramic NP coatings 
prevent deposits and enhance fuel efficiency of engines (I). Co: 
Titanium dioxide NPs for UV resistant paints, self-cleaning, 
repel of water, dirt and contamination, non-stick and stable (I). 
Co: NPs are used in protective coatings for wood and floors, and 
could potentially add flame retardancy (I). Co: Odour 
remediation (S). Mnf: Ceramic NP coatings and less common 
nanomaterials enhance mould release and anti-icing (I). 
Co: Nanoporous aerogels for insulation (S).  

Silver for antibacterial, and other noble metals for healthcare 
(aluminium hips). Magnetic iron-based alloys for energy 
transmission. Light metals with superior mechanical properties 
(Al and Mg alloys, Ti and Ti alloys) for structural applications. 
Ae: Silver NPs embedded in supports and polymers as 
antimicrobials (S). Au: Catalytic converters (I). Co: Silver NPs 
on ceramic substrates or embedded in polymers as antimicrobials 
(S). Co: Nanostructured alloys render steel much stronger, 
together with carbon nanotubes (CNT) (S). Mnf: Silver NPs 
embedded in supports and polymers as antimicrobial (S). Mnf: 
Specially engineered NPs improve properties like flow and 
dispersion (I). Mnf: Coatings based on polymers and organic-
inorganic particles to prevent crystallisation, fouling and 
corrosion (I) Mnf: Filtration solutions using hollow nanofibres, 
antifouling coatings (I) Med: silver NPs for medical instruments 
and fabrics as antimicrobials and drug carriers (S). 
Co: A low-density nanoporous aerogel for insulation (I). Zeolites 
(with a scaffolding made of silicon, aluminium, and oxygen) 
with pore diameters from 0.3-1 nm for various sectors of 
industry (S). 

CNT/polymer composites and foams with high electrical 
conductivity for applications in conventional cold cathode or 
polymer LEDs. 
Ae: CNTs for Cu replacement in wiring (I). Au: CNTs to prevent 
static build-up on fuel lines (S). Co: CNT to add strength to 
cement (S). El: Nanostructured devices for active cooling with 
highly conductive features to provide thermal contact (I). EE: 

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nm 

Double-walled nanotubes 
(DWNTs) 

CNTs embedded in epoxy for stronger wind turbine blades (with 
weight halved while doubling blade diameter) (I). Mnf: Sensors 
based on CNTs and nanostructured devices for monitoring (I). 

Fullerenes and 
POSS (Polyhedral 
oligomeric 
silsesquioxane) 

Fullerenes, 1 nm in 
diameter 

POSS made of silicon and 
oxygen atoms 

Fullerenes used as fillers and in some cosmetics. 
El: Fullerenes for resists, anti-static packaging for semiconductor 
wafers, and nanoimprint lithography (S). 

Other carbon 
nanomaterials 

Carbon black, graphite, 
nanoherring, carbon based 
nanofilms, graphene 

Combination of C, Si, N, 
B, Ti, e.g. C3N4 , Si3N4 
covalent carbides like SiC 
and B4C and metallic 
carbides like TiC or LaC2  

Quantum dots 

Nanosized crystals of 
semiconductor materials 

Dendrimers  

Dendrimers, 2 nm to 20 
nm diameter 

Nanostructured 
materials 

Nanometre-sized metal 
grains or layers of various 
materials 

Nanowires 

Metallic and 
semiconducting wires, 
<100 nm in diameter and 
many microns in length 

Nanopolymers  

Bionanomaterials 

Nanostructured polymers 
and fibres (10 nm 
diameter) 

Engineered biomolecules 
(oligonucleotides, 
peptides, proteins, and 
bioactive molecules) with 
size 0-1,000 nm 

Nanoencapsulation   Liposomes, micelles, solid 

lipids, polymersomes, 
emulsions, and silicon 
dioxide shells as 
encapsulators 

Carbon black for applications e.g. in car tyres, antistatic textiles, 
cosmetics, colouring. Nanographite for pigment production, as 
additive to rubber and plastic products, and as electrode materials 
for batteries, fuel cells and supercapacitors. Graphitic 
nanoherring catalyst support materials. Graphene can be used in 
electronic applications, such as transparent conductive films – or 
even transistors and sensors. 
Carbide nanofilms and nanocristalline carbonfilms, e.g. 
“diamond-like carbon” (DLC). 

Quantum dots can be used for diagnostics, bio-labels and next-
generation solar cells. 

El: Nanoscale engineering and NPs like QDs and dendrimers 
boost LED output and enable precision optical elements (I). 

Ae: Nanostructured metallic alloys and nanoporous materials for 
stronger and lighter aircraft, reducing fuel consumption (I). Au: 
Nanostructured metals for lightweight and strong moulded auto 
parts (I). EE: Nanoscale electrodes for higher performance of 
rechargeable batteries (I). EE: Catalytic converters in cars (I). 
Mnf: Diamond nanocrystals and nanostructured metal 
composites for more durable industrial parts (S). 
Nanowires for smaller, faster microchips and memory devices, 
and also for displays, energy storage devices and sensors. 
Au: Memory technologies, electrical wiring, and 
interconnections (I). El: Nanostructured electrodes and NP 
electrode coatings for better consumer devices (I). El: Soldering 
and bonding at lower temperatures protects nearby components 
(I). 
Nanopolymers for applications in the transport and packaging 
industries. Nanofibers for filtration of air and liquids.  

Co: Light-control materials (I). EE: New processes enable bio-
based packaging materials to be made from waste or 
strengthened for longer usage (I). 

Encapsulators improve solubility and bioavailability of 
ingredients, protect molecules from degradation, shield 
undesirable qualities like taste or smell, provide optical clarity, 
and improve the texture of cosmetic products.  

Nanoclays 

Nanoclays (layered 
platelets of clays, 

Primarily as polymer additives: 
Ae: High-heat thermoplastics used for interiors may also 

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generally aluminosilicon 
dioxidete ceramic 
materials) 

incorporate nanoclays (I). Au: Nanoclays for lightweight and 
strong moulded auto parts (I). Mnf: Nanoclays for flame 
retardant electrical cable claddings, metal nanocomposites for 
stronger cables (I). 

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Annex 3: List of Acronyms 

CASG Nano 

REACH Competent Authorities Sub-group on Nanomaterials 

CEFIC 

Conseil Européen de l’Industrie Chimique 

CEN 

European Committee for Standardisation 

CENELEC 

European Committee for Electrotechnical Standardisation 

CIP 

CLP 

Competitiveness and Innovation Programme 

(Regulation on) Classification, Labelling and Packaging (of substances and 
mixtures) 

EC 

European Commission 

ECHA 

European Chemicals Agency 

ECVAM 

European Centre for the Validation of Alternative Methods 

EESC 

EFSA 

EGE 

EIT 

European Economic and Social Committee 

European Food Safety Authority 

European Group on Ethics in Science and New Technologies 

European Institute of Innovation and Technology 

ELS(A) 

Ethical, Legal and Societal (Aspects) 

EMEA 

European Medicines Agency 

ENIAC 

European Nanoelectronics Initiative Advisory Council 

EPA 

EPAA 

EPO 

ERA 

ERC 

US Environmental Protection Agency 

European Partnership on Alternative Approaches to Animal Testing 

European Patent Office 

European Research Area 

European Research Council 

ESFRI 

European Strategy Forum on Research Infrastructures 

ETP 

ETSI 

European Technology Platform 

European Telecommunication Standards Institute 

EU-OSHA 

European Agency for Safety and Health at Work 

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FPN 

HSE 

ICPC 

ICT 

IEC 

IPR 

ISO 

IST 

Nth Framework Programme of the European Community for research, 
technological development and demonstration activities 

Health, Safety and Environmental (issues) – also referred to as EHS (issues) 

International Cooperation Partner Countries 

Information and Communication Technologies (in FP7) 

International Electrotechnical Commission 

Intellectual Property Rights 

International Organization for Standardization 

Information Society Technologies (in FP6) 

IUPAC 

International Union of Pure and Applied Chemistry 

JRC 

JTI 

JU 

KBBE 

KIC 

NEST 

(European Commission) Joint Research Centre 

Joint Technology Initiative 

Joint Undertaking (e.g. ENIAC JU) 

Knowledge-Based Bio-Economy (in FP7) 

Knowledge and Innovation Networks (of EIT) 

New and Emerging S&T (in FP6) 

NIEHS 

US National Institute of Environmental Health Sciences 

NIOSH 

US National Institute for Occupational Safety and Health 

nm 

NMP 

NoE 

NSF 

nanometre, 10-9 metres  

Nanosciences, Nanotechnologies, Materials and New Production 
Technologies (in FP6 and FP7) 

Network of Excellence 

US National Science Foundation 

OECD 

Organisation for Economic Co-operation and Development 

OECD-CSTP  OECD Committee for Scientific and Technological Policy 

PRINS 

Pan-European Research Infrastructure for Nanostructures 

R&D 

Research and Technological Development 

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REACH 

(Regulation on) Registration, Evaluation, Authorisation and Restriction of 
Chemicals 

SCCP 

SCCS 

Scientific Committee on Consumer Products (up to March 2009) 

Scientific Committee for Consumer Safety (from March 2009) 

SCENIHR 

Scientific Committee on Emerging and Newly Identified Health Risks 

SICA 

SME 

SRA 

S&T 

Specific International Cooperation Action 

Small and Medium Enterprise 

Strategic Research Agenda (of ETP) 

Science and Technology 

STAIR 

Standardisation, Innovation and Research 

TC 

Technical Committee (e.g. CEN/TC, ISO/TC) 

UNGHS 

UN Global Harmonisation System 

USDA 

US Department of Agriculture 

VAMAS 

Versailles Project on Advanced Materials and Standards 

WPN 

(OECD) Working Party on Nanotechnology 

WPMN 

(OECD) Working Party on Manufactured Nanomaterials 

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