EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 29.10.2009 
SEC(2009)1468 
  
COMMISSION STAFF WORKING DOCUMENT 
Accompanying document to the 
 
COMMUNICATION FROM THE COMMISSI ON 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} 
 
EN 2   EN COMMISSION STAFF WORKING DOCUMENT 
Accompanying document to the 
 
COMMUNICATION FROM THE COMMISSI ON 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 
  
Nanotechnology
1 has the potential to enhance quality of  life and industrial competitiveness in 
Europe. The “integrated, safe and respons ible 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 developm ents. After the first two years of the Action 
Plan, progress in almost every area was id entified in the First Implementation Report.4 This 
report covers actions undertaken and progre ss made during 2007-2009 in relation to the key 
areas identified in the Action Plan. Where a ppropriate, for the sake of completeness and 
continuity, developments in preceding years ar e included. In this Staff Working Document 
detailed information on progress can be foun d, while the Communication to which it is 
attached outlines the key devel opments 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 Ac tion Plan, and is dealt 
with mainly under the re spective policy areas. 
TABLE OF CONTENTS 
1. RESEARCH................................................................................................................. 7 
1.1. R&D Funding............................................................................................................... 7 
1.2. 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, ty pically, 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/LexU riServ.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/LexU riServ.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/LexU riServ.do?uri=COM:2007:0505:FIN:EN:PDF  
 
EN 3   EN 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 ............................................................................................... 1 4 
1.2.3.3. Regenerative medicine............................................................................................... 15  
1.2.4. Converging sciences and t echnologies; 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 a nd 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 exposur e throughout the life cycle ......................................... 28 
1.3.4. Research on potential ecotoxicity, environmental fate and behaviour ...................... 29 
1.3.5. Research on life cycle assessm ent (LCA) of nanomaterials ...................................... 30 
1.3.6. Sources of information on research on hea lth, 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........................................................................................................ 3 2 
1.4.3. Nanomedicine ETP .................................................................................................... 32 1.4.4. Sustainable Chemistry (SusChem)............................................................................. 33 1.4.5. Micro- and Nano-Manu facturing (MINAM) ............................................................. 34 
1.4.6. European Technology Platform on Industrial Safety (ETPIS) .................................. 34 1.5. EuroNanoForum 2009................................................................................................ 35 1.5.1. Environmentally sustainable and en ergy-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 
 
EN 4   EN 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 Responsib le Development of Nanotechnology................ 39 
2. INFRASTRUCTURES .............................................................................................. 40 3. HUMAN RESOURCES............................................................................................. 43 4. INDUSTRIAL INNOVATION ................................................................................. 47 4.1. General situation ........................................................................................................ 4 7 
4.2. General innovation policy a pplicable to nanotechnology.......................................... 48 
4.3. Opportunities in particul ar technology sectors .......................................................... 50 
4.3.1. Nanomaterials for Elec tronics and Photonics ............................................................ 51 
4.3.2. Nanomaterials for th e 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 th e 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 an d Standardisation, ................................................................ 58 
4.4.3. Nanotechnology standards: New achievements and developments........................... 59 4.4.4. Plans for future standardisation activ ities: The CEN report to the Commission’s 
programming mandate and the Commission’s response............................................ 61 
4.4.5. Metrology, pre- and co-normative resear ch, and tools for measurement quality 
assurance .................................................................................................................... 63  
4.5. Patents ................................................................................................................... ..... 65 
4.6. OECD Working Party on Nanotechnology (WPN) ................................................... 65 5. SOCIETAL DIMENSION......................................................................................... 67 5.1. Code of Conduct for responsible nanosc iences and nanotechnologies research ....... 67 
5.2. Ethical issues............................................................................................................ .. 68 
5.2.1. Ethical issues in the 7
th Framework Programme........................................................ 68 
5.2.2. Promotion of Alternatives to Animal Testing............................................................ 69 
 
EN 5   EN 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 co mmunication 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, ENVIRONMENTA L AND CONSUMER PROTECTION ... 74 
6.1. Nanomaterials on the market ..................................................................................... 74 6.1.1. Nanomaterials in resear ch 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. Safety concerns associated w ith the use of nanomaterials......................................... 83 
6.4. 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 thro ughout the life cycle.............................................................. 86 
6.4.4. Potential ecotoxicity, envir onmental fate and behaviour........................................... 87 
6.4.5. Life cycle assessment (LCA) of nanomaterials ......................................................... 88 6.5. Research on health, safety and environm ental issues – Furthe r priorities from a 
regulatory perspective ................................................................................................ 88 
6.5.1. Measurement methods, reference ma terials 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 th roughout the life cycle......................................................... 91 
6.5.5. Life cycle Assessment (LCA) .................................................................................... 92 6.5.6. Exposure mitigation ................................................................................................... 92  
6.5.7. Environmen tal fate..................................................................................................... 9 3 
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 
 
EN 6   EN 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 Commissi on Actions in Nanotechnology Action Plan 2005-
2009.......................................................................................................................... 1 00 
Annex 2: Nanomaterials on the market.................................................................................. 104 Annex 3: List of Acronyms.................................................................................................... 10 7 
 
EN 7   EN 1. RESEARCH 
Bringing together public and private organisa tions across Europe to perform collaborative 
research and development (R&D) in nanotechnology is vital for the interd isciplinary 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 orde r to generate the “triangle of knowledge” 
needed for the European Research Area of knowle dge for growth. This is the general strategy 
pursued in the successive Resear ch Framework Programmes (FPs).5 Given the diversity of the 
underlying scientific approaches and the applicati ons 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 assessmen t; and links this work to industrial needs 
identified by several European Technology Plat forms relevant to nanotechnology. There are 
also sections on the results from the recent Eu roNanoForum conference; and the international 
cooperation activities. The next two chapters, on infrastructure s 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 polic ies, programmes and 
projects. Under the 6th Research Framewor k 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 575 41.9
IST 466 33.9
Marie Curie6 161 11.7
Health7 57 4.2
Infrastructures8 40 2.9
NEST9 24 1.7
                                                 
5 Framework Programmes of the European Commun ity for research, technological development and 
demonstration activities – general information at http://cordis.europa.eu/  
6 Specific programme “Structuring the European Research Area”, “Marie Curie Actions - Human 
resources and mobility” 
7 Thematic priority “Life sciences, ge nomics and biotechnology for health” 
8 Specific programme “Structuring the European  Research Area”, “Research Infrastructures” 
 
EN 8   EN SME10 17 1.2
Others 33 2.4
TOTAL 1,374 100
The period 2007-2009, which is covere d by the present report, coin cided with the first three 
years of the 7th Research Framework Programme (FP 7, 2007-2013). Whilst final figures for 
2009 are not available at the time of writi ng, 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 diffe rent themes, with the dedicated NMP theme 
(Nanosciences, Nanotechnologi es, Materials and new Produc tion Technologies) accounting 
for just over 50 % and the ICT theme (Info rmation 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 nanotechnologi es have an interdisciplinary and enabling 
character and can contribute to different industrial sectors and policy obj ectives in health, 
food, environment, energy and transport. 
Table 2 Nanotechnology research funding in FP 7 (2007-2008) by theme or programme 
FP7 Theme / 
Programme EU 
funding 2007, M€ EU 
funding 2008, M€ EU 
funding 2007-08, M€ 
NMP 282 314 596
ICT incl. FET13 148 26 174
ENIAC14 0 32 32
Marie Curie 
(People) 74 51 125
ERC (Ideas) 18 61 79
                                                                                                                                                         
9 Specific programme “Integrating an d Strengthening the European Rese arch Area”, “New and Emerging 
Science and Technology” 
10 Specific programme “Integrating and Strengthening the European Research Area”, “Specific SME 
activities” 
11 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. 
12 Despite the fact that these programmes do not target  particular areas or app lications, 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 eval uations. This trend is expected to continue. 
13 Future and Emerging Technologies objective 
14 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. 
 
EN 9   EN Health 23 14 37
Energy 17 20 37
Infrastructures 1.5 27.7 29
SME 12 7 19
Food and 
biotechnology 0 2 2
Science in 
society 0 1.3 1.3
TOTAL 576 556 1,132
It is interesting to follow the evolution of industrial particip ation in nanotechnology projects 
supported by the NMP theme: In the nanotechno logy projects selected in the period 2007-
2008, industry accounted for 40 % of all participations.15 As was reported in the previous 
implementation report, the indust rial participation in nanot echnology 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 i ndustry in the nanotechnolog y topics included in 
this theme, although inevitably th is is still lower th an in NMP projects that do not involve 
nanotechnology (where industry accounts for 57 % of all participati ons). The industrial 
participation in nanotechnology projects suppor ted by the ICT theme,  which on the whole 
addresses more mature a pplications, is higher. 
The Commission is also carry ing out nanotechnology research directly, through its Joint 
Research Centre (JRC). The JRC activities span a wide range of  nanotechnology areas 
including nanotoxicology and pot ential environmental impact; metrology, standardisation and 
the development and production of reference mate rials; environmental remediation; and, in 
the energy area, hydrogen production and st orage, and catalysts for fuel cells. 
Global expenditure on nanotechnol ogy research, both public and pr ivate, in the three-year 
period 2004-2006 was around EUR 24 bi llion. Europe accounted fo r more than a quarter of 
this worldwide total, with the EU funding dire ctly 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. Howe ver, in Europe, privat e funding accounted for 
only 40 % of the total, whereas in the world as a whole priv ate funding was overtaking public 
funding (as of 2008). 
Table 3 Global nanotechnology research funding (public and private) in 2005-2006 and 
2007-2008
16 
2005-2006 2007-2008 Billion € 
public private TOTAL public private TOTAL 
                                                 
15 These figures refer to participation in individual projects, i.e. counting participations of the same 
beneficiary in different projects cumulatively. 
16 For the purposes of an approximate global comparison, figures are given in EUR, using 2005 exchange 
rates. Sources: European Commission and Lux Research 
 
EN 10   EN EU 3.4 1.9 5.3 3.8 2.5 6.3 
US 2.8 3.1 5.9 2.6 4.1 6.7 
Japan 1.5 2.4 3.9 2.7 4.4 7.1 
Russia 0.8 0.8 
China 0.8 0.3 1.1 
Others 1.5 0.9 2.4
1.5 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 addi tion to the projects covered he re, other funded projects have 
addressed risk assessment (treated in the next section); and areas of policy such as outreach, ethics, innovation, metrology and c oordination of selected  activities (treated in other parts of 
this report). Finally, project s funded by the “People” and “Id eas” specific programmes are 
often in fundamental nanosciences, and thus complement to some extent the application-
oriented domains described here. Also comple menting the domains described here are the 
activities of an FP6 ERA-N ET and an FP7 ERA-NET Plus
17 on nanosciences, NanoScience-
Europe,18 with a current consortium of 17 national f unding 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 improve ments 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-effi cient computers and other digital devices, for 
the everyday use of all businesses and virtually all types of consum er. The pace of this digital 
revolution is still acceler ating, 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 se nse, 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 nanoma terials, which are produced by manipulating 
                                                 
17 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.  
18 http://www.nanoscience-europe.org/  
 
EN 11   EN 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 to day have lateral features more than a hundred times smaller – 
just 90 nm or 65 nm, approximate ly a thousand times smaller than the width of a human hair. 
That may be small, but in the competitive semi conductor 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 phone s, vehicles, satellit es, and so on. And, 
because the processed silicon wafers out of wh ich chips are made are increasingly expensive 
(setting up a factory to produce them today costs EUR 3 billio n), 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 approach ing its physical limits, 
however, and disruptive approaches are needed to maintain this trend. Current transistor 
candidates for future technologies are significan tly different from trad itional transistors and 
fall entirely within the realm of nanotechnology. Some of th ese 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 dedi cated 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. Th e Commission identified nanoelectr onics as a strategic area 
where the new funding mechanism of a Join t Technology Initiative (JTI) could be 
implemented. The ENIAC Joint Undertaking (J U), the legal instrument implementing the 
industry-oriented part of the Strategic Resear ch Agenda (SRA) of th e ENIAC ETP, is active 
since the beginning of 2007. The ENIAC JU ha s already launched two calls for proposals.
19 
Following the first call in 2007, eight projec ts are already underway  with a total public 
funding of EUR 90 million (EU and Member Stat es combined). The total public funding for 
the second call of 2009 was EUR 104 million. 
As examples of EU-funded research proj ects 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 crea te 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 pred iction made by Intel co-founder 
Gordon E. Moore in 1965 that the number of tran sistors that can be cost-effectively placed on 
a chip will double approximately every two years. 
                                                 
19 http://www.eniac.eu/web/ca lls/callforproposals.php  
20 http://www.pullnano.eu/  and http://www.nanocmos.ac.uk/  
 
EN 12   EN Progress has been made in the resolution obtaine d in top-down structuring of nanoelectronics 
devices: 
– Optical lithography methods – using 193 nm exposure wavelength with liquid immersion 
(water) and simultaneous appl ication of double exposure – can  produce features below 30 
nm. It is expected that so -called computationa l lithography can extend optical lithography 
even down to 20 nm (from design to mask maki ng and the final exposure of the silicon 
wafer, all processes are optimised by numeri cal simulation of the individual steps). 
– EUV (extreme ultraviolet) lithography – using 13 nm exposure wavelength – can bring 
resolution down to 10 nm or less; this coul d 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 advant age 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). He re resolutions in 
the 10 nm to 20 nm range have been demonstr ated. Introduction into industry is expected 
in the next two to four years. 
Nanoimprint technology is not cons idered here, as it is limited to  applications where only one 
mask level is sufficient to make a product (e.g. ma gnetic heads). The reason for this is that the 
template allows only a one-to-one pattern tr ansfer 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 Delf t, in cooperation with Arizona State 
University, have “written” tungsten-containi ng dots with an average diameter of 1 nm, 
thereby setting a new world record and proba bly 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 vola tile ones are pumped away. 
– Molecular self-assembly using DNA nanotec hnology, e.g. to make DNA nanotubes. The 
DNA is used as a structural material rather th an 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 mo re easily modified and connected to other 
structures. 
In Europe, there are four main regional cluste rs 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 we ll as in access networks . Photonics is also an 
enabling technology that exploits advances in la sers, light sources, fibr es and detectors; in 
materials (e.g. nanotubes, nanocrystals and organi cs); and in architectures and manufacturing 
processes (hybrid integration, s ilicon photonics and CMOS compatib ility). It promises to play 
a major role in new areas such as energy conservation (e.g. by improving photovoltaic and 
lighting efficiency), medicine, biology, envi ronment and safety. The possibility to 
 
EN 13   EN manufacture structures at the na noscale – well below the wavele ngth of light – will radically 
change traditional approaches, by exploiting physical effects not previously accessible. 
Europe has strong and recognised R&D capab ilities, as well as SMEs, in photonics. 
– The MONA project (Merging Optics and Nanot echnologies) was launched in June 2005 to 
bridge the gap between photonics and nanot echnologies. 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 integr ation of electronics and photonics. 
1.2.3.  Nanomedicine 
Nanomedicine is the application of nanotechnology to health. It can improve qual ity 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 effici ent and targeted diagnosis, treatment, and 
monitoring of disease. This is relevant to th e treatment of a wide va riety of diseases from 
cancer to diabetes; cardiovascular, immunol ogical, inflammatory, musculoskeletal and 
neurodegenerative disorders (Alzheimer’s and Pa rkinson’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 car e costs and leading to affordab le healthcare for an ageing 
population. 
The Nanomedicine ETP has identified three areas of industrial priority in nanomedicine 
research: diagnostics including medical imagi ng; targeted drug delivery; and regenerative 
medicine. These are described in separate sub-sections below. 
The NMP, Health and ICT themes are all invo lved 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 pa rticipation of 18 states  and regions. The first 
joint call for transnational proj ects closed in September 2009. 
Ethical, legal, social, and regulatory aspects are of particular importance for the successful 
development of nanomedicine. There are th erefore several EU-funded support actions to 
address these issues (e .g. NanoMed Round Table). 
Devices and nanomaterials used in nanomedicin e 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 diagnos is 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 be ing 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 tr end towards “point-
                                                
 
21 http://www.euronanomed.net/  
 
EN 14   EN of-care” diagnostics, allowing a sample to be an alysed by the doctor or the patient, without 
the need for a central laboratory. 
Early diagnostics are based on the identificatio n of disease-related biomarkers, which could 
offer an earlier and more personalised assessment before the onset of symptoms. Nanotechnology can help achieve early diagnos tics, 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, nanotec hnology allows the development of improved, 
targeted contrast agents providi ng a better identification of diseas ed tissues, for instance with 
X-ray or magnetic resonance imag ing (MRI). Molecular imaging, based on the use of specific 
targeted contrast agents, plays a crucial role in the non-invasive loca lisation of a disease, 
minimising discomfort and pain for the patient. 
Related to diagnostics, is the id ea 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, us ing target-specific contrast nanopharmaceuticals. 
Then, combined with further pharmacologically ac tive agents, or with other stimuli (e.g. laser 
light), the same targeting strategy can be us ed for applying the appr opriate therapy. Finally, 
the monitoring of the effect s of treatment is possible by further sequential imaging. 
Examples of relevant projects include: VIBRANT: Around 30 million people in Europe cu rrently suffer from diabetes, with an 
incidence of 7.5 % in Member States. This de vastating disease is ranked among the leading 
causes of fatal cardiovascular  diseases, kidney failure, neur opathy, lower limb amputation and 
blindness. At present, no c linically established methodol ogy exists for non-invasive in vivo 
imaging and quantification of insulin-producing beta-cells in the panc reas, whose dysfunction 
is responsible for diabetes. VIBRANT propos es a new nanotechnology-based method for the 
MRI imaging of beta-cells. Furthermore, targ et-specific drug-loaded nano-containers will 
offer high potential for cell-directed therapies. 
CAREMAN: Diagnostic devices based on bios ensor technology coupled  with detection 
capabilities and integrated sample handling aim to tackle the most common diagnostic 
problems currently faced in EU hospitals – su ch 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 tran sport 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 bigge st 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 com pound relies on the ability to reach the intended 
target, for example to cross the blood-brain ba rrier 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 direc tion and release of a 
 
EN 15   EN drug using magnetic nanoparticles. In all cases, the target must be identified by discovering 
and validating new biomarkers on th e basis of molecular recognition. 
Nanopharmaceuticals and nanodevices can also be  activated by external means (magnetic 
resonance imaging, focused ultras ound, radiotherapy or lasers), in  order to deliver an intended 
physical effect in a localised or systematic way. This effect could be h eat or radiation to kill 
tumour cells. Alternatively, the external means ca n 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 proteoli posome 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 deliv ered to disease sites via the patient’s 
bloodstream and then activated by focused ultr asound pulses, the project aims to maximise 
the therapeutic efficiency and minimise the si de 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 de velop MRI techniques that simultaneously image 
the patient’s anatomy, detect the arrival of MR I-labelled drug-loaded particles at the disease 
site, measure the local heating effect of the ultrasound pulses, and monitor the temperature-
triggered release of drug s from the particles. 
NANOEAR: This project aims to develop ther apies for inner ear disorders, using novel 
multifunctional nanoparticles that ar e targetable to selected ce ll populations for controllable 
drug release. 
1.2.3.3.  Regenerative medicine 
A broad definition of regenerative medicine in cludes the repair, replace ment 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 ar eas: smart biomaterials and 
advanced cell therapy. Therapies based on ti ssue engineering represent a breakthrough in 
regenerative medicine, through the use of inte lligent biomaterials, smart implants, and cell-
based techniques. 
The focus of regenerative medicine is to stimul ate tissue regeneration a nd repair by using the 
body’s self-repair mechanisms. This process ca n 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 phys ical and chemical events at the nanoscale, which 
occur during the interaction of several cell ty pes (including neurons and stem cells) with 
nanostructures, is of paramount importance fo r the fabrication of biocompatible surfaces to 
induce stem cell proliferation and differe ntiation, and to guide neuronal growth. 
TEM-PLANT: This project aims to use hierarchical structures that naturally exist in plants, to 
generate innovative biomedical devices desi gned for bone and ligament substitution. This 
 
EN 16   EN 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 t echnologies; nanobiotechnology 
Nanobiotechnology is a broad fiel d of knowledge and techniques,  involving the convergence 
between nanotechnology and the basic componen ts of life: proteins, DNA and cells. The 
interface of these fields has th e potential to provide revolutio nary scientific and technical 
approaches to address existing and new app lications. 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 biologi cal systems and proce sses within the cell 
operate at the nanoscale. Functiona l biological units, such as prot eins, 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 appro ach. 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. Amongs t the most innovative nanomedicines currently 
under development are nanostructures functioning as  release systems for completely synthetic 
oligonucleotides. 
Like nanotechnology, nanobiotechnol ogy is a strongly interdisci plinary 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 applica tions in medicine (nanomedic ine) and biotechnology (food, 
industrial applications and environmental monitoring). On th e other hand, we try to learn from 
nature, so that we can build useful systems at  the nanoscale, using proc esses similar to those 
optimised by nature over millions of years. C ontrary to popular belief, it is impossible to 
make conventional machines at the nanosca le, 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 us ing certain biological molecules as building 
blocks. These could be used to make sortin g devices for molecules, or in developing 
nanoscale manufacturing. For example, th e Hy3M project (H ydrogen-bond geared 
Mechanically Interlocked Molecular Motors) crea ted 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 abov e, developments in nanobiotechnology can be 
brought together in the field of nanomedicine,  the application of nanobiotechnology to health. 
Another emerging area of relevance for nanom edicine is the convergence of biological, 
information and cognitive sciences. One exampl e 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 (biot echnology and food) and NMP included five 
coordinated topics on nanobiotec hnology, which were met with an excellent response: Smart 
devices to study biomolecular dynamics in real time; functionali sed membranes; bio-
 
EN 17   EN interfaces for environmental applications; appl ying 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 re search involves the developm ent of nanostructures with 
controlled physical properties. Such nanostructures can have a significant impact in energy 
and environmental applications, nanoelectroni cs and photonics, nanomedicine, catalysts for 
the chemical and pharmaceutical industry, and so on. Environmentally sustainable growth can 
result from a more efficient use of materi als and energy, and from cleaner transport. 
Self-assembly essentially involves interactions  at a higher level an d lower strength than 
standard chemical bonds, forming structures with  an ordering beyond that of their individual 
components, i.e. nanostructures. Closely relate d to self-assembly is the concept of self-
organisation. One can distinguish between pro cesses where the building blocks carry specific 
information directing the self-assembly th rough recognition; and processes based on 
templated growth methods, where building blocks  are deposited onto pr e-patterned substrates 
and their assembly is directed by the pre-exis ting pattern. These processes may in addition be 
assisted by external factors such as electro magnetic 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 se t of desired and controllable properties. The 
control of the process and the characterisati on of the resulting structures are the usual 
challenges in this field. In the longer term, it is desirable to fi nd ways of “up-scaling” such 
processes, to make them industrially relevant. In  addition to scale, uniformity is an important 
consideration in up-scali ng. Several projects have been or ar e being funded in this broad area, 
with mixed results: Often, the particular app lications 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 pa rticipation in such projects 
has tended to be peripheral, but is growing. 
Projects currently selected fo r funding in this area generally have an increased focus on 
realistic applications, although the production scale remains a ch allenge. In 2009, this activity 
was complemented by a call topic on molecular ma nufacturing, 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 nanot echnology-based solutions within existing or 
new production lines. 
1.2.6.  Tools for nanosciences and nanotechnologies 
While nanoscience is not enti rely new, since the inventi on of the Scanning Tunnelling 
Microscope (STM) and the Atom ic Force Microscope (AFM) in  the 1980s, researchers have 
developed increasingly powerful techniques for “seeing” and controlling objects, surfaces and 
structures at the nanoscale. Mo st applications in nanotechnology discussed elsewhere in this 
section became possible after that, highlight ing the importance of developing appropriate 
instruments for material characterisation. Furthe rmore, 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 we ll as in the first calls of FP7, 
have addressed this area. Releva nt topics included “Pilot lines  to study, deve lop and up-scale 
nanotechnology-based processes from la boratory”; “Equipment and methods for 
 
EN 18   EN nanotechnology”; “Specific, easy-to-use portable devices for measurement and analysis”; and 
“Pilot lines to introduce nanotech nology-based processes into the value chain of existing 
industries”. 
The Nanobeams Network of Excellence concentrat ed on analytical techniques using focused 
ion and electron beams in order to develop anal ytical techniques and instruments matching the 
requirements of nanomaterials. This network combined the efforts of manufacturers of 
scientific instruments with those of le ading research laboratories in the field. 
Relevant projects selected under FP7 include several examples where combinations of 
atomic-scale characterisation technologies introd uce new capabilities, such as the following: 
– 3D NanoChemiscope: 3-dimensional chemical ch aracterisation of nanos tructured 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 backs cattered electrons dire ctly at the surface 
– with nanoscale resolution; 
– MDSPM: Imaging of metallic, semiconducting and insulating surfaces with unprecedented 
resolution, expected to improve our understand ing of entire areas of  surface science such 
as chemical reaction dynamics, local energy dissipation and excitati ons, nanoscale contacts 
and a rational approach to cat alyst 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 th e correlation between st ructure 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 conventio nal techniques, and possibly detection of 
different types of DNA based on their electrical properties. 
Inspection and monitoring systems for secur ity is another importa nt area addressed, 
exemplified by current research projects: 
– TeraEye: Scanning systems detecting harmfu l materials based on passive THz detection, 
supporting a radical transformation in the security sector; and 
– Dinamics: Nano-biological sensing for detectio n of biological threat s, and environmental 
assays using a lab-on-a-chip de vice that will be able to detect pathogens in water. 
1.2.7.  Industrial applications, including pilot lines 
Significant investments have been made thr oughout FP6 in long-term research in various 
fields of nanoscience. In many cases, these pr ojects have produced resu lts in the laboratory 
environment (for example in terms of desire d properties), but the transfer of promising 
nanotechnology research results in to new industrial technologies st ill represents a bottleneck. 
In order to accelerate the introduction of nanot echnolgy-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 industr ial processes and producti on lines. The projects 
are also expected to demonstrate how na notechnology can significantly improve the value-
chain in industrial producti on towards high-added-value innovative products, thereby 
enhancing European competitiveness. 
 
EN 19   EN The calls have been met with a good respons e from both the research and industrial 
communities. Seven projects have been funded, w ith 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 proj ects have over 150 participants, including 30 
large industrial partners and 43 SMEs, making the industrial particip ation close to 50 %. 
Technology demonstration is a significant component  of these projects, w ith nearly a quarter 
of the effort dedicated to demonstration acti vities. To allow sufficient time for technology 
demonstration, most projects will run for four y ears. 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 industr ial applications, they were not designed to be sector- or 
application-specific. As a result, they cover a wide range of applic ations and processes: 
– Electrochromics for shading appliances; 
– Atmospheric plasma deposition for na noscale industrial surface processing; 
– Atmospheric pressure plasma processing for 3D nanostructured surfaces; 
– Nanopatterning based on na noimprinting 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 lubrican ts incorporating nanomaterials. 
A holistic approach is common for the projects  covering, for example, (i) development of 
scalable nanomaterial producti on technologies; (ii) developmen t of large-scale processing 
technologies that can be used with the pr oduced nanomaterials;  and (iii) technology 
integration and pilot-scale demonstration of r eal, industrial applications. Ensuring the safe 
production of nanomaterials, as we ll as the safety of the final a pplication or product, forms an 
integral part of the projects. 
The pilot-line projects are expected to resu lt in significant improvements in productivity, 
sustainability, product quality and its control; an d to demonstrate the eco nomic viability of the 
use of nanotechnology in their respective applicati on 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, severa l other projects target industrial applications: 
for example, CANAPE on the production of  carbon nanotubes; AMBIO on nanostructured 
surfaces to control bio-fou ling; and INDOT on the producti on of nanophotonic devices. 
Turning to the general outlook for industrial app lications, the second half of FP7 is expected 
to see a gradual shift towards more applicat ion-oriented researc h, as nanotechnologies 
developed in a laboratory environment evolve towards applications in various industrial 
sectors. A shift is also expected towards call to pics that are more specifi c to particular sectors 
or technologies, as part of th e effort to generate critical mass and more strategic impact for 
selected application fields of high priority. The potenti al for nanotechnology-enabled 
industrial applications in different sectors is  outlined in section 4.3. 
 
EN 20   EN 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 ca ll “Nanotechnology fo r harvesting energy 
via photovoltaic tec hnologies”, with the objective of supporting innovative scientific and 
technical research for improved efficiency, brin ging devices with a more favourable cost per 
unit-area. The call was me t 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 to day is based on crystal line silicon, because of 
the high module efficiencies that can be achie ved. Yet the technology is rather expensive. A 
sizeable number of the proposals therefore focu s on solving this issu e through alternative 
approaches using silicon, significantly reduc ing the cost without compromising the cell 
efficiency. Another popular topic was the enhancement of the performance of second-generation thin-film cells, whil e maintaining low production costs. The proposals typically 
take into consideration the scaling-up of the la boratory results, as well  as the construction of 
prototype cells with the help of industrial pa rtners, for a realistic proof of concept and 
eventual industrial take-up. There is good reason to believe that the f unded projects will pave 
the way for highly efficient phot ovoltaic cells with costs we ll 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 genera tion and refrigeration re quiring a high power 
output. For example, in vehicles using intern al 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 nanos tructured materials can  significantly enhance 
the efficiency and selectivity of these proce sses (through process intensification and reduction 
of by-product generation), and reduce their energy consumption (through lower pressure 
drops). This leads to a much gr eater 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 det oxification of water streams (t argeting cyanobacterial toxins, 
pesticides and endocrine  disrupting compounds). 
– MEMBAQ aims to mimic the se lective transport of wate r through plant leaves by 
incorporating the plants’ selective channel st ructures, aquaporins, in  polymer membranes. 
– MONACAT aims to produce flow-through catalyst  units for the reduction of nitrates, 
bromates, and perchlorates, and for the oxidatio n of a range of organic pollutants including 
pesticides and endoc rine disruptors. 
– NAMETECH aims to enhance the permeability and stability of membranes for water 
treatment, while reducing thei r 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 st reams through electrodialysis. 
 
EN 21   EN – WATERMIM aims to produce highly selectiv e “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 relate d industries, being the 
basis for more than 20 % of the world’s indu strial production proce sses. Catalysts are key 
factors in minimising demands on energy and raw materials, as well as in reducing emissions 
from industrial chemical production. Since ma ny 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 ar e 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 su stainable manufacturing. 
Nanomaterials can be particularly effective as cat alysts, leading to reductions in raw material 
and energy costs, improvements in selectivity an d the minimisation of waste streams in many 
industrial processes. Using nanom aterials also allows reducti ons 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 oxide s have in catalysis and surface chemistry, it is 
not surprising that nanostructured oxides
22 can have a significant impact in fields like the 
production of petrochemicals (e.g. reforming of  light hydrocarbons), in termediates and fine 
chemicals, with the benefits described above. There are further benefits in environmental 
protection, for example in the abatement of NO x, SO 2 and VOCs (volatile organic 
compounds). It is estimated that  by 2020, nanostructured oxides wi ll represent about one third 
of the total demand for metal oxides (including cata lysis and other applica tions), 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 bi orefinery that can handl e various feed stocks.24 
1.3. Research on health, safety a nd 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 meas urements, including equipment. This section 
describes only the research aspects of risk assessment, while chapter 6 presents the overall picture with regard to health, environmen tal and consumer protection, including the 
regulatory aspects. 
                                                
 
22 New compound oxides containing non-transition metals, such as doping TiO 2 with anions such as 
(carbon and nitrogen are not anions), SnNb 2O6 or BiVO 4 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. 
23 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  
24 R. Coons (2009), Catalysts: Seeking the Next Big Thing, Chemical Week, May 4, pp. 19-21, 
www.chemweek.com; ICIS Chemical Business (200 9), Catalyst creativity – Innovative catalysts 
promise to improve the economics of chemical production, May 4-10, pp. 28-29, http://www.icis.com  
 
EN 22   EN Since 2005, the EU Scientific Committees have hi ghlighted in their opinions the paucity of 
information in areas that are fundamental to th e further development of guidelines on the risk 
assessment of nanomaterials. These are:  
(1) Information on nanomaterials on the market; 
(2) Methods with comparable, reproduci ble and repeatable results;  
(3) The choice of the most appropriate metr ics for hazard and exposure assessment; 
(4) Actual human and environmental exposure; 
(5) Methods to extrapolate from the toxi cology of non-nanoscale materials to 
nanomaterials; between nanopartic les; and from laboratory te sts to actual hazards to 
humans (including more sensitive groups) and the environment; 
(6) Toxicokinetics of nanomaterials from vari ous portals of entry to target organs, 
including possible new endpoints;25  
(7) Environmental fate, distri bution and persistence (inc luding bioaccumulation and 
biodegradability), and ecot oxicity of nanomaterials. 
Research projects and support actio ns designed to address the con cerns 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 ha s 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 develo ping applications in order to integrate safety 
aspects at the earliest possible st age, in accordance w ith the “integrated, sa fe and responsible” 
development of nanotechnologies and the Commission’s Code of Conduct.26 
A compilation of HSE research projects f unded 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 strate gic planning, a “nanosafety cluste r” was formed in February 
2009 for research projects addressing nanotechn ology 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 a nd the environment; test methods including 
alternative test methods; 
– Models and calculations to  predict and assess toxic ity, exposures and risks; 
                                                 
25 In the context of toxicity and ecotoxicity, end points are properties related to human health and 
environmental safety. They should provide basic characterisation, fate, ecotoxicity and mammalian 
toxicity information for nanomaterials. 
26 Commission Recommendation on a Code of Conduct for responsible nanosciences and 
nanotechnologies research , C(2008)424; section 5.1 below 
27 States associated to FP6 and FP7 
28 ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/final-version.pdf  
29 ftp://ftp.cordis.europa.eu/pub/na notechnology/docs/final_report.pdf  
 
EN 23   EN – Database and information needs; 
– Fate and behaviour of nanopart icles in the environment; and 
– Risk assessment and life cycle assessment. 
Coordination in this area is also aide d 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 resear ch 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 th e future, the intention is to integrate all 
stakeholders’ dialogues in a European Technol ogy Platform, complemented and assisted by 
national platforms. These activit ies 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 th e interaction mechanisms of 
nanomaterials with biological systems, as we ll 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 describe s aspects of risk management linked to the 
progress of this research, and section 6.5 outli nes further research necessary to close the 
knowledge gaps. 
1.3.1.  Characterisation, metrology and reference materials 
It is widely acknowledged that  a proper characteris ation of nanomateri als in terms of a 
number of key physicochemical properties is essential for a sound comparison of 
toxicological test results. Wo rk within the OECD-WPMN and IS O/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; aggreg ation and agglomeration 
state; composition; shape; solubility; disper sibility; surface area; surface chemistry (for 
example hydrophobicity); and surf ace charge. Testing methods exist for all these parameters, 
although not all are as yet validated for us e with nanomaterials, nor standardised. 
It is clear that the physicochemical characteris ation of nanomaterials tested for toxicity in 
various biological media is a challenge in itse lf. Even between labora tories with adequate 
equipment and specific expertise there is no t 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 lis ted properties, their 
measurement cannot easily be outsourced and p hysically separated from the toxicology test. 
This calls for increased collaboration betw een physicists, chemists, biologists and 
toxicologists. This collaborat ion will necessarily involve stages of round-robin testing to 
                                                 
30 More information on the work in the context of these two international organisations can be found in 
section 6.6 
31 Guidance Manual for the Testing of Manufact ured Nanomaterials – OECD-WPMN Sponsorship 
Programme, ENV/JM/MONO(2009)20 
32 Interlaboratory Study to Establish Precision St atements for ASTM E2490- 09 Standard Guide for 
Measurement of Particle Size Distribution of Nanom aterials in Suspension by Photon Correlation 
Spectroscopy (PCS), Research Report E56-1001, ASTM Committee E56 on Nanotechnology, 
Subcommittee E56.02 on Characterisation: Physical , Chemical, and Toxicolo gical Properties, April 
2009 
33 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 
 
EN 24   EN assess the proficiency of laboratories and repr oducibility of methods, following the rules of 
metrology.34 35 A recently started coordination ac tion 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 l eading 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 refere nce nanomaterials continue to be distributed 
by the JRC (nanoporous powders and na noscale thin films on substrates).
38 In the absence of 
formally certified reference mate rials, it is good prac tice 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 mate rials can develop into reference materials 
when data about homogeneity and stability beco me 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 te sting purposes. It focu ses on various forms of 
titanium dioxide, cerium oxide, zinc oxide, si lver, silicon dioxide, and carbon nanotubes, 
which are targeted by the OECD-WPMN spons orship programme (see sub-section 6.6.1). 
1.3.2.  Research on potential human health hazards 
Progress has been made in several aspects of re search on toxicity te sting and on potential 
effects of nanomaterials on human health. Th is area has been addressed by numerous 
completed and ongoing EU-funded proj ects. The findings from some  of these projects were 
published in the proceedi ngs of the workshop of April 2008, mentioned above.
39 
In addition to the EU-funded projects, JRC ac tivities in this area focus on the development 
and harmonisation of methods for the toxi city testing of nanomaterials; and the in vitro  testing 
of a representative set of nano materials 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, quan titative structure-activity 
relationships). 
CANAPE: This integrated project addresse d the production of car bon nanotubes on an 
industrial scale. As part of this work, it considered tests for different endpoints (such as 
biocompatibility) and their valid ity in defining the toxicologi cal 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 mech anical action; and that no diffusive transport 
takes place. Thus penetration studies with st atic Franz-diffusion cells do not seem adequate 
for nanoparticles. Clearance is  expected to proceed via desquamation. There is deep 
                                                 
34 ISO/IEC Guide 99-12:2007 International Vocabulary of Metrology - Basic and General Concepts and 
Associated Terms , VIM 
35 ISO/IEC Guide 43 Proficiency testing by interlaboratory comparisons , ISO, Geneva, 1997 
36 http://www.co-nanomet.eu  
37 http://www.nano-refmat.bam.de/en/  
38 http://irmm.jrc.ec.europa.eu/catalogue  
39 ftp://ftp.cordis.europa.eu/pub/na notechnology/docs/final_report.pdf  
40 http://www.uni-leipzig.de/~nanoderm/  
 
EN 25   EN penetration into hair follicles, but not into vital tissue. Clearance is expected to proceed via 
sebum excretion. 
DIPNA41 addressed the impact of metallic and cer amic nanoparticles on different types of 
cells, and designed assays and instrument s for field analysis of nanotoxicology. 
NanoInteract42 developed a platform and toolkit for understanding interactions between 
nanoparticles and the living world. This include d the issue of reproducibility. In 2007, a paper 
from this project, “Understanding the nanopartic le-protein corona using methods to quantify 
exchange rates and affinities of proteins for na noparticles”, received on e 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 an d cardiovascular target systems. The project 
developed detailed procedures to  investigate the association between short-term variations in 
air pollution and cardiovascular h ealth, which can be used in future European studies. Data on 
levels of air pollutants, in part icular 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 efficien cy of protective equipment. 
The main conclusions were as follows: There is considerable evolution of nanoaerosols over 
time; their average size increases, while thei r concentration decrea ses. Natural background 
aerosols are scavengers for nanoparticles; the time scale for size evolution depends on the 
concentration of nanoparticles and that of b ackground 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 coordina tion 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 a nd metal oxide nanomaterials. The review 
considered sources, pathwa ys of exposure and outcomes of health and environmental concern, 
informing regulatory activities. A fi nal report is expected soon. 
                                                 
41 http://www.dipna.net/  
42 http://www.nanointeract.net/  
43 http://www.fp6-cellnanotox.net/  
44 http://www.iom-world.org/r esearch/particle_risk.php  
45 http://research.dnv.com/nanotransport/  
46 http://www.impart-nanotox.org/   
47 Engineered Nanoparticles: Review of Health and Environmental Safety , 
http://nmi.jrc.ec.europa .eu/project/ENRHES.htm  
 
EN 26   EN 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 cellula r pathways and trafficking, 
differentiation process, substrate targeting, up take, efficacy and toxicity; process modelling. 
NanoTEST:50 Alternative testing strategies for the risk assessment of nanomaterials used in 
medical diagnostics. This includes high-thr oughput toxicity-testi ng protocols, using in vitro  
cell lines (blood, vascular syst em, liver, lung, central nervous  system, digestive system, 
placenta and kidney) for mechanistic studies (on oxidative stress, inflammation, immunotoxicology, genotoxicity an d barrier transport); and valid ating these with  short term in 
vivo studies and by developing in silico  methods. 
ENPRA
51 addresses a part of the hazard assessment of  nanomaterials. In particular it aims to 
identify the critical physicochemical characteris tics of nanomaterials, which are responsible 
for the observed toxicity, by inve stigating their interactions at the cellular and molecular 
levels. Such mechanisms are underlying the ob served association and developing systems. 
They will be verified by performing in vivo  experiments leading to the development of 
possible high-throughput alternat ive 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 incorpor ating 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 hazar dous effects of engineered nanomaterials on 
the immune system. 
NeuroNano (with three US, one Brazi lian 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 diseas es? Understanding the origin of reactive 
oxidative species and prot ein aggregation in the pr esence of nanoparticles. 
NanoReTox (with one US partner): The reactivity and toxicity of engin eered nanoparticles: 
risks to the environment and human health. 
InLiveTox: Intestinal, Liver and Endothelial N anoparticle Toxicity – Development and 
evaluation of a novel tool fo r 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 impact of na nomaterials derived from processing, 
weathering and recycling of polym er nanocomposites used in va rious industrial applications. 
                                                 
48 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. 
49 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 . 
50 http://www.nanotest-fp7.eu/  
51 Risk Assessment of Engineered Nanoparticles , http://www.enpra.eu/  
52 http://ki.projectcoordinator.net/~NANOMMUNE  
53 http://www.neuronano.eu/  
 
EN 27   EN Finally, the NANOGENOTOX Join t Action, bringing together ei ghteen Member States, is 
funded under the Commission’s Second Health Programme.54 It focuses on the “safety 
evaluation of manufactured nanom aterials by characterisation of their potential genotoxic 
hazard.” The nanomaterials considered will include titanium dioxide, silicon dioxide and carbon nanotubes. NANOGENOTOX focuses not onl y on the generation and exchange of 
data, but also on the further development of re liable testing methods. It  supports the European 
contribution to the work taking place unde r 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 Commis sion created the European Partnership on Alternative 
Approaches to Animal Testing (EPAA). This has promoted cooperation with industry and 
other stakeholders. The partners are committe d to pooling knowledge, research and resources 
to accelerate the development, validation and acce ptance of alternative approaches. The aim is 
to develop tools in genomics, computati onal technologies and high-throughput testing 
systems, to assess the safety of chemi cals, including pharmaceuticals, vaccines, food 
additives, pesticides and cosm etic products, and to achieve an  unprecedented d ecrease in the 
use of experimental animals. 
Extensive research is underway on alterna tive ways of assessing safety, and on the 
possibilities of refining, reducing and ultimatel y replacing animal testing. The most recent 
commitment was by the Commission, th rough the FP7 Health programme,
55 and the European 
cosmetics industry (Colipa) for research into alternative testing met hods. 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 valu e. The results of the projects may benefit not 
only the cosmetics industry, but also the pharm aceutical 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 info rmation, reapplication of solutions across 
sectors, and internati onal regulatory dialogue. 
The Commission’s JRC also hosts the European Centre for Validation of  Alternative Methods 
(ECVAM),56 which performs research on the devel opment of alternativ e testing methods 
directly targeting animal tests to be replace d. Following scientific validation by ECVAM, the 
test methods have to be validated in the OE CD before their acceptance for global use and a 
mutual acceptance of data.  
In order to promote the development of altern ative 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-th roughput 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 ma terials, extrapolating the results from in vitro  to in 
                                                 
54 The Second Programme of Community Action in the Field of Health 2008-2013, 
http://ec.europa.eu/health/ph_programme/pgm2008_2013_en.htm  
55 Call FP7-HEALTH-2010-Alternative-Testing 
56 http://ecvam.jrc.it/  
 
EN 28   EN 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 harm onisation and formal va lidation process in the 
ECVAM and later on in the OECD. 
The OECD-WPMN has a steering group (SG7), ch aired by Germany and the Commission, on 
the role of alternativ e methods for assessing the safety of nanomaterials, which aims at 
integrating alternative test methods and test ing strategies, and suppor ts the validation of 
methodologies where applicable. Alternative testing methods ar e 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 expos ure throughout the life cycle 
Research on exposure has so far focused on wo rkplace exposure, as this is potentially the 
most important exposure route. Two FP6 proj ects 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, ventilat ion 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  NANOSH 
Nanosafe2  Combination of measurements to distinguish manufactured 
nanomaterials from other 
nanoparticles Principles demonstration, pilot measurements in labs and industry 
production sites showing feasibility of 
their applications 
Characterisation of particles from sampling, labelling  NANOSH  Use of precipitators for direct deposition of nanomaterials on 
TEM grid and others (e.g. particle 
size analysers; scanning microscope)
 Pilot studies showed feasibility of its application 
On-line detection and measurement methods including assessment of various methodologies Nanosafe2
 Development of new devices for 
sampling (and on-line detection) including assessment of various methodologies
 Demonstration of principles, development of low cost alarm devices, of devices for large size range NPs, of analysers showing feasibility  
 
Personal exposure NANOSH 
Nanosafe2  Direct deposition of nanomaterials on TEM grid in breathing zone and other methods
 Measurements done in production facilities of nanomaterials and other powders (eg micro zinc oxide) showing feasibility
 
Qualitative assessment of dermal exposure NANOSH Introduction of a slightly modified 
version of a structured questionnaire (DREAM) Pilot studies showed feasibility of its application and evidence of dermal exposure potential
 
Decrease of particle release during production of nanomaterials Nanosafe2
 Development of reactor for 
synthesis of powders  Demonstration of principles showing feasibility, work continues in the project SAPHIR
 
Air purification, respirators, personal protective equipment NANOSH 
Nanosafe2 Filter efficacy testing  Completed and pilot study performed  
Release of nanomaterials from 
textiles Nanosafe2 Test method and equipment for 
nanomaterials release  Standard method proposed and proposed 
for formal standardisation work 
Calibration Nanosafe2 Methods and equipment for 
measuring instruments calibration Completed equipment demonstrated at 
laboratory scale  
                                                 
57 http://www.olis.oecd.org/olis/2009doc.ns f/LinkTo/NT0000498A/$FILE/JT03267857.PDF , p. 20 
58 http://www.ttl.fi/Inter net/partner/Nanosh/  
59 http://www.nanosafe.org/  
60 http://www.oecd.org/dataoecd/36/36/42594202.pdf  
 
EN 29   EN 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 fo llowing FP7 projects started recently: 
NanoDevice,61 a large collaborative project, will deve lop reliable methods and equipment for 
the measurement of nanoparticle s, in particular novel, port able 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-te rm 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 l ook at the relationship between the 
physical structure of the nanopa rticles and their toxicity. 
NANEX: Development of Exposure Scenario s for Manufactured Nanomaterials , is a support 
action that will collect and re view exposure data, exposure metrics, risk management 
measures and existing models. It s goal is to develop and standa rdise a catalogue  of generic 
and specific exposure scenarios fo r nanomaterials, taking their en tire life cycle into account, 
and covering occupational, consumer and envi ronmental 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-se ction 1.3.2) studied the fate a nd effects of aggregated CeO 2 
nanoparticles in water and concl uded that no acute toxicity was observed for any of the three 
different environmental species tested. For chroni c aquatic toxicity, it c oncluded that toxicity 
is related to the surface area and not excl usively 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 maki ng standard ecotoxicity test methods more 
reliable for nanomaterials is th e collection of knowledge on di rect and indirect effects of 
nanomaterials. Hypothesis testing and the assess ment of non-standard endpoints may play an 
important role in this process. Finally, it was co ncluded that it is advisa ble to analyse different 
endpoints and consider the app earance of measurement artef acts 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 Know ledge for Environmental 
Protection) was initiated. This is  a partnership of 17 national f unding agencies in 13 different 
countries, responsible for funding environmen tal research. The SKEP network aims to 
facilitate science-led policy making, a nd to support eviden ce-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 nanostruc tures throughout their life-cycle , and to suggest means that 
might reduce or eliminate these impacts. 
                                                
 
61 see, e.g., ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/nanodevice_kai_savolainen.pdf  
62 http://www.skep-era.net/site/2.asp  
 
EN 30   EN NanoFATE: Nanoparticle Fate Asse ssment and Toxicity in the Environment . The work seeks 
to assess the environmental fate  and potential risks of specifi c nanomaterials used in high-
volume products, for which recyc ling is not an option: fuel additives, personal care and 
antibacterial products. Two commercially releva nt nanomaterials derived from each one of 
three substances (CeO 2, ZnO and Ag), of varying size, surface and core chemistry, will be 
monitored throughout their post-production life cy cles, i.e. from environmental entry as 
“spent product”, through waste treatment, to their final fate s and possible toxic effects. 
1.3.5.  Research on life cycle asse ssment (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 projec t 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 scalin g data). Major efforts are needed 
to assess fully potential risk s 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 prospectiv e view on the environmental, he alth and safety aspects of 
different nanomaterials: 
NanoHouse: Life Cycle of Nanoparticle-based Products used in House Coating . 
NanoSustain:  Development of sustainable solution s for nanotechnology-based products based 
on hazard characterisation and LCA . 
1.3.6.  Sources of information on research on hea lth, 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 substa nces in specific applications. European-based 
and other publicly accessible databases are as follows: 
– The EU-funded NHECD64 project was launched in D ecember 2008, with the aim of 
creating a “critical and comme nted database on the healt h, safety and environmental 
impact of nanoparticles” based on data-minin g techniques; an overview of all available 
databases is given on the website of this project. 
– EUPHIX,65 a web-based knowledge system that pres ents structured European public health 
information with a special insight into sim ilarities and differences in various Member 
States. 
– SAFENANO,66 a searchable database on reports, j ournal and magazine articles on health 
and safety aspects of nanomaterials operated by the Institute of Occ upational Health (UK). 
                                                 
63 http://lct.jrc.ec.europa.eu/eplca  
64 http://www.nhecd-fp7.eu/  
65 http://www.euphix.org/object_document/o4581n27010.html  
66 http://www.safenano.org/ AdvancedSearch.aspx  
 
EN 31   EN – The Nano Archive,67 a part of the FP7 project ICPCNanoNet,68 provides free access to 
published nanoscience research in the EU a nd International Cooperation Partner Countries, 
related to environmental,  health and safety aspects of nanotechnologies,  
– The Commission’s JRC developed and laun ched the NAPIRA hub, an information 
management system on nanotechnology safe ty, 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 (earli er this database was supported by the US 
Woodrow Wilson Centre). 
– Finally, the EU-funded NanoImpactNet70 is a coordination actio n for projects on HSE 
research, which will also communicate results to stakeholders and their needs back to researchers; and make contributions to infr astructure and traini ng (as mentioned in 
chapters 2 and 3 below). 
1.4. European Technology Platforms 
Several European Technology Platforms (ETPs)  are either dedicat ed to nanotechnology 
applications or address applications in whic h 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 EuMaT
71 
(Advanced Engineering Materials and Technol ogies); Hydrogen and Fuel Cell Technology72 
(in collaboration with th e 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 devel ops 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 rese arch agenda, along with the CATRENE cluster, 
while the more upstream research is funded un der 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- a nd technology-intensive sector. 
                                                 
67 http://www.nanoarchive.org/view/subjects/HA.html  
68 http://www.icpc-nanonet.org/content/view/26/39/  
69 http://www.oecd.org/about/0,3347,en_2649_37015404_1_1_1_1_37465,00.html  
70 http://www.nanoimpactnet.eu/  
71 http://www.eumat.org/  
72 http://ec.europa.eu/research/fch/index_en.cfm ; this ETP led to the Fuel Cell and Hydrogen JTI  
73 http://www.artemis.eu/  
74 http://www.smart-systems-integration.org/  
75 http://textile-platform.eu/  
76 http://www.eniac.eu/  
77 http://www.eniac.eu/web /downloads/SRA2007.pdf  
 
EN 32   EN The Eureka78 cluster CATRENE79 for “Application and Technology Research in Europe on 
Nanoelectronics” is a fo ur-year programme that started in January 2008 and is extendable to 
eight years. It builds on the success of the previous EURE KA programmes JESSI, MEDEA 
and MEDEA+ to foster the continued development of a dynamic and competitive European industry in nanoelectronics. The total effo rt will be around 4,000 person-years per annum, 
equalling about EUR 6 billion for the extended programme. 
1.4.2.  Photonics21 ETP 
Photonics21
80 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 es tablish Europe as a leader in  the development and deployment 
of photonics in key indust rial areas, including ICT, lighting and displa ys, 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 Ja nuary 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 ma rket 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 fo r photonics research. This has resulted in an ERA-NET Plus 
being set up which will join tly 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, hospita ls, research orga nisations and uni versities. It 
also includes representatives of funding agen cies from Member States and Regions. The 
Nanomedicine ETP currently has around 130 memb er 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 pa per 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 fo r 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 c onsideration 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 nanomedicin e above. Three years after the 
publication of the SRA for nanomedicine, th e 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 thei r expected impact on applica tions, products and markets. 
                                                
 
78 http://www.eureka.be/  
79 http://www.medeaplus.org/web/about/presentation.php  
80 http://www.photonics21.org/  
81 http://www.photonics21.org /download/sra_april.pdf  
82 http://www.photonics21.org/downloa d/Brosch_Photonics_Europe.pdf  
83 http://www.etp-nanomedince.eu/  
84 http://www.etp-nanomedicine.eu/public/public/press- documents/publications/strategic-research-agenda  
 
EN 33   EN 1.4.4.  Sustainable Chemistry (SusChem) 
The European Technology Platform for Sustainable Chemistry (SusChem)85 seeks to boost 
research, development and innovation in chemis try, biotechnology and chemical engineering. 
Chemistry is ubiquitous and vital for the qualit y of modern life. More and better use of 
chemistry will enable European society to be come more sustainable. This requires major 
innovations in chemistry, as well as a successf ul and healthy European chemical industry. Not 
only is innovation in chemistry a key to the su stainable growth of the European chemical 
industry, but it also acts as a catalyst for su stainable innovation in upstream and downstream 
industries, including consumer product sect ors. Furthermore, sustainable chemical 
technologies can improve public conf idence 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 co mmunication technologies (new 
processing technologies, integration of nanostr uctures, 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, informati on and communication tec hnologies, as well as 
various nanotechnologies direct ly. SusChem has carried out an  impact assessment, which 
found that the following topics in  its IAP have yet to be suffic iently 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 effi ciency of batteries, and high-
power batteries for transport applications; (v) integration of high-energy batteries for 
applications in renewable and distributed ener gy networks; and (vi) supercapacitors using 
ionic liquid electrolytes for long-life, high-voltage and hi gh-temperature applications. 
Taking also into account the current topics of in terest 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 partic ular batteries, (organic) phot ovoltaics 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, in cluding 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 resear ch on new functional materials such as piezoelectric films 
in microsystems; stabilisation of primar y particles on surfaces; nanomaterials for 
thermoelectrics; corrosion prevention, for in stance alternative materials for tinplate 
passivation; 
                                                 
85 http://www.suschem.org  
86 http://www.suschem.org/content.php?_document[ID]=2049&pageId=3217  
 
EN 34   EN – Finally, self-assembled and smart surfaces are seen  as areas of future strategic importance. 
The Smart Energy Home Visionary Project of Su sChem integrates the possible benefits of 
using nanomaterials for construction and retr ofitting, as smart materials and surfaces, self-
cleaning surfaces, sound insulation and for active noise abatement.87 
The latest SusChem stakeholder event in Pr ague 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, ha s continued to grow, with a 
membership reaching 700 and increasing partic ipation in various policy and implementation 
activities. The active involvement of European industry, including SMEs, in research has been a key objective of the MINAM as sociation, in addition to its general goal of establishing a 
new industry for the manufacturing of products based on emerging micro- and 
nanotechnologies. 
MINAM has contributed to the FP7 call pla nning, in micro- and na no-technology, materials 
and production, and is actively supporting the de velopment of nanotechno logy research with a 
clear industrial potential. Recommendations fr om 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. “NANOfutu res” should serve as a hub for all relevant 
sectors: 
– Identifying common elements and creatin g synergies between the ETPs and, where 
appropriate, with national and regional programmes, ER A-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 nanotechnolog y, materials, and “horizontal ” technologies that will 
enable competitive and sustainable developm ents in a range of industrial sectors. 
MINAM furthermore contributes to several ot her 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 descri bed in sub-section 1.3.3 above 
is integrated in ETPIS.93 
The iNTeg-Risk project, linked to the Focu s Group on Emerging Risk of ETPIS, aims to 
coordinate R&D for improving the management  of risks related to new materials and 
                                                 
87 http://www.smartenergyhome.e u/downloads/seh_leaflet.pdf  
88 http://www.suschem.org/content.php?pageId=3602&lang  
89 http://www.minamwebportal.eu/  
90 http://www.mnt-era.net/MNT/  
91 http://www.industrialsafety-tp.org/ne ws.aspx?lan=230&tab=148&nid=88#n88  
92 See for example http://euvri.risk-technologies.com/events/event_3/default.htm  
93 See for example 
http://www.nanosafe.org/script s/home/publigen/content/template s/show.asp?P=69&L=EN&SYNC=Y  
 
EN 35   EN technologies. This should reduce the time to  market for lead tech nologies, as well as 
promoting safety, environmental friendliness a nd 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 include d. The project will essentially: 
identify specific emerging risks from particul ar study cases; develop solutions for the 
identified risks; validate the solutions, disse minate them through the iNTeg-Risk “one-stop 
shop” and finally ensure continuity.94 This project started in December 2008; its initial 
activities were pr esented at a conference in June 2009. 
1.5. EuroNanoForum 2009 
EuroNanoForum 2009 was a four-d ay conference in Prague on 2-5 June 2009, organised with 
EU support as an event of the Czech Presidency, under the auspi ces of the Czech Ministry for 
Education, Youth and Sports. Prev ious events in the EuroNanoFo rum series were organised in 
2003, 2005 and 2007 (by the Presidencies of Italy, the United Kingdom and Germany, 
respectively). The theme of the 2009 conferen ce, which was attended by more than 700 
participants from 36 countries, was the sustai nable development of European industry and 
society. It also showcased industrial technologies enabled by nanotechnologies. 
The conference highlighted a broad spectrum of  nanotechnologies, whic h could significantly 
contribute to industries including chemicals, automotive, shipping, aeronautics, construction, 
textiles, food, biotechnology, healthcare, ma nufacturing, power gene ration 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, nanotechno logies and converging sciences. 
Following the presentations in  plenary sessions and associ ated panel discussions, the 
participants arrived at the following conclusions: 
1.5.1.  Environmentally sustainable and ener gy-efficient industrial production 
The interest in nanomaterials an d metal nanoparticles as catalysts  is increasing, as a means of 
achieving reductions in energy c onsumption 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-ge neration 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 su stainable and renewable energy, in the form of 
photovoltaics, wind generation and thermoelectri c conversion systems. Any new technologies 
should be suitable for large-scale application,  and capable of provi ding reliable, stable 
solutions. Amongst the highlighted research resu lts fulfilling these crit eria are solar cells 
based on dye-sensitised nanocry stalline titanium dioxide. 
                                                 
94 http://www.integrisk.eu-vri.eu/home. aspx?lan=230&tab=51&itm=192&pag=196  
 
EN 36   EN 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 engi neered 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 tec hnologies still exist. Neverthe less, nanotechnology is helping to 
bring about important advances  in diagnostics, dr ug 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 scaffold s are helping to treat previ ously incurable conditions. The 
conference called for a better cooperation amongs t 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 el ectronics and improved design of devices are 
evident, while breakthroughs from bottom-up appr oaches (e.g. molecular electronics) are still 
in their infancy. The recommendation is to stre ngthen public-private partnerships and improve 
education in Europe. 
1.5.5.  Governance of nanotechnology 
– Several interdependent concerns are expre ssed by industry, including ETPs, and European 
policy makers, in research and development, health, environment, consumer protection, competitiveness, and so on. There is thus a n eed for a more effective European cooperation 
on horizontal nanotechnology issues, in particular standardisation;  education; ethical, legal 
and societal aspects; a nd communication and outreach. 
– Further dialogue and joint actions between gove rnments, funding agencies, industries and 
research entities are essential in achieving a prosperous sustainabl e 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 la rge, in order to overcome 
misconceptions created by ill -informed media comment. 
– In order to support the continuing industria lisation 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 a nd wider international 
cooperation are needed in the fields of safety, health and environmental protection. 
– The market success of nanotechnology applic ations depends very much on the 
development and validation of measurement a nd testing methods and the establishment of 
the corresponding standards. 
1.6. International Collaboration in Nanotechnology Research 
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 intern ational cooperation partner countries (ICPCs) 
can receive EU funding. 
                                                 
95 That is, countries other than Member  States and FP7 Associated States 
 
EN 37   EN In the NMP Work Programmes in particular, so me research topics have been introduced 
specifically to address international collaboratio n, for example in the field of environmental, 
health and safety impacts of engineered nano materials. The international participation in 
nanotechnology projects of NM P was around 5 % in 2007-2008, with  84 participations from 
18 third countries. 
Further actions to promote inte rnational cooperation include: 
– Coordinated calls to address obj ectives of mutual interest (for example with countries 
having signed S&T cooperation agreements with the EU); 
– Specific International Coope ration Actions (SICAs); 
– Specific initiatives to promote the particip ation 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 ha rmonised standards and nomenclature; 
– Initiatives to coordinate and ex change 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 research ers 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 to wards enhancing the EU-U S collaboration in the 
field of HSE impacts of engineered nanopartic les. The first NMP call of FP7 included the 
topic “Risk assessment of engi neered nanoparticles on health and the en vironment”. Although 
this topic was not formally within a coordinated call, th e 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, NI EHS and the Woodrow Wilson Centre).97 A new 
coordinated call is included in the 2010 Wo rk 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 http://www.ims.org/  
97 Although the US participation in proposals submitted in  response to these calls has been encouraging, it 
must be noted that the contract ne gotiations have often been delayed because of issues related to the 
legal provisions of the FP7 Grant Agreement. As a ru le, the US partners are required to sign the FP7 
Grant Agreement even though they  do not receive a financial co ntribution 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. Th e situation has improved, but not wholly resolved, after the 
introduction of new Speci al 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. 
 
EN 38   EN NIESH, USDA, NIOSH) is bei ng prepared on “Environmental a nd biological fate, transport, 
and transformation of engi neered nanomaterials”. 
1.6.2.  Collaboration with ICPC countries 
As mentioned above, the number of ICPC particip ations in nanotechnology projects is fairly 
good, even though the low selection rates mean that  this participation is  somewhat scattered. 
Coordinated calls and Specific International C ooperation Actions (SICAs) can lead to more 
targeted investment and impact, in addressing ar eas of mutual interest. The general goal is to 
boost cooperation with both developed and deve loping countries. A number of coordinated 
calls were launched in the last  year of FP6 and the first ye ars of FP7, addressing areas of 
mutual interest to the EU and a number of  international partne rs. Amongst these ICPC 
partners, one can cite India (on computational material sc ience) 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 fundi ng of EUR 5 million. 
The 2009 Work Programme of NMP includ ed 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 speci fic applications were defined, the objective 
being to fund one project in each: 
– Optical chemical sensing with nanopartic les, 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 meta l oxide semiconductor 
nanostructured materials.98 
A further topic was specified for a support action on the “mapping of nanotechnology and 
nanostructured materials research infrastruc tures in Russia”, with EU funding of EUR 
350,000.99 The projects resulting from the coordinate d 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 fo r this call is EUR 6 
million; some of this is to be dedicated to pa rticipants from other ICPCs, from Latin America 
in particular, in an attempt to promote a re gional approach in international cooperation. 
                                                 
98 The proposals consider ed for funding are: 
INGENIOUS – developing novel ultr a-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 sensor s operating in an unprece dented temperature range 
(from -20°C to +650°C). 
S3 – developing toxic and explosive gas sensing technol ogies with higher sensitivity and selectivity at reduced 
cost, with sensing principles based on molecularly engineered semiconductor nanowires. 
99 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. 
 
EN 39   EN The ICPC participation in EU-funde d research is often limited b ecause of insuffi cient contacts 
with EU researchers. To ameliorate this  situation, the FP7 pr oject ICPC-Nanonet,100 with 
partners from the EU, China, India and Russia, aims to provide: 
– an electronic archive of nanoscience publicatio ns 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, I ndia, 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 to pic on “Coordination acti ons with materials 
researchers in major world regions” in th e 2008 Work Programme of NMP. The proposals 
selected for funding in this topic provide EU re searchers with the possi bility 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 di alogue 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 othe r global forums, never 
duplicating what is done competently and succ essfully elsewhere, but paving the way for 
formal discussions in selected areas. 
Building on the previous di alogues of 2004 in the US a nd 2006 in Japan, the European 
Commission was pleased to organise the 3rd In ternational Dialogue for Responsible Research 
and Development of Nanotechnology, which was held in Brussels on 11-12 March 2008 and 
gathered 97 participants repr esenting 49 countries, as well as  international organisations, 
industries and universities. 
The Third Internationa l Dialogue addressed: 
– Nanotechnology governance, debating in more de tail (i) the EU-US call for proposals on 
the impact of nanoparticles on health and the e nvironment, as an example of international 
research on a topic of global in terest; (ii) activities of leading international institutions and 
organisations; and (iii) the code s of conduct adopted or in pr eparation. How synergy can be 
improved between stakeholders was examine d, and proposals have been made for the 
exchange of good practises (e.g. on conditions at the workplace), as well as for coordinated 
                                                 
100 http://www.icpc-nanonet.org/  
101 Although the international dialogue is also relevant to other chapters of this report, it is presented here 
for the sake of completeness. 
 
EN 40   EN “observatory” activities, including indicators of responsible and sustainable innovation or 
the implementation of the codes of conduct. 
– “Bridging the gap”, a very inform ative session illustrating various  initiatives, in particular 
the IBSA initiative (India, Brazil, South Af rica), and exploring how to better achieve a 
meaningful access to knowledge by all countri es, in the so-called North-South, North-
North or South-South cooperati on. 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 im portance of launching coordinated activities on global 
challenges was highlighted, su ch as nanotechnology for wate r purification, environmental 
remediation, and sustainable development in ge neral. Also highlighted were joint projects 
where the immediate industrial or commercial inte rest is not apparent, but the societal or 
environmental benefits are considerable. In  addition, organisational challenges were 
addressed. 
– Societal engagement, debating the experien ce acquired by a global ne tworking of social 
scientists and hearing th e lessons learnt from dialogue with  the public in different countries 
and by different stakeholders. The value of  information, communi cation, dialogue and a 
constant “listening mode” was consistently hi ghlighted. Good practices were presented and 
debated. 
2. INFRASTRUCTURES 
The availability of excellent pan-European Rese arch Infrastructures (RIs) with critical mass 
and interdisciplinary ch aracter 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. Th e ESFRI Roadmap of 2006,102 with its 2008 upda te, 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 conc eived as a distributed infrastr ucture, based on three European 
centres of excellence, IMEC (Belgium), CE A-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 und er a common umbrella. PRINS will bring 
together an unprecedented array of equipment and know-how in topics like high resolution 
lithography, advanced process st eps and modules, electronic sy stems integration, imaging 
devices, silicon-based micro-systems, and miniat urised “nano-bio” devices. The open access 
provided to the scientific community by PRIN S will enable innovative research and a truly 
cross-disciplinary fertilisation of academic and industrial competences. It should allow 
progress in the scaling of co mponents and circuits (e.g. for nanoelectronics, nanophotonics 
and nanosystems) by allowing the convergence of  “top-down” technology, which is today the 
                                                 
102 ftp://ftp.cordis.europa.eu/pub/esfri/d ocs/esfri-roadmap-report-26092006_en.pdf  
103 http://www.prins-online.eu  
 
EN 41   EN main enabler of Moore’s law, with “bottom-up”  methods derived from disciplines such as 
materials science, chemistry, nanobio technology and particle electronics. 
PRINS builds on the FP6 projects MNTE and STAR, as well as the FP7 project MNTEE. 
These projects supported the cr eation and upgrading of a unique distributed platform for R&D 
in micro and nanotechnologies. PRINS is now s upported financially in its preparatory phase 
under FP7, with an EC contribution of EUR 1 m illion. The PRINS PP aims to involve all the 
stakeholders necessary to make the project mo ve forward; to make decisions on the legal 
structure, the operation mode and the governance model; and to  make financial commitments 
before construction can start. Th e 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 th e construction costs can only be very limited. 
Nevertheless, indirect participation in the construction costs is possible, by facilitating loans through the new Risk Sharing Fi nance Facility (RSFF), an innova tive idea of leveraging 
Community funds available under FP7 through the European Investment Bank (EIB). There is 
also a possibility of making use of Structur al Funds, but to a more limited extent. 
EUMINAfab :
104 In addition to supporting the deve lopment of new RIs, the Commission 
supports existing RIs through the In tegrating Activity (IA) model (the continuation of the FP6 
“I3” model). EUMINAfab is such an integra ting 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 star ted in March 2009 with 
an EU contribution of EUR 6 million, and involv es six academic and four industrial partners. 
It supports the networking of existing facili ties, 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. EU MINAfab is expected to develop a knowledge 
management system for multi-material micro- and nano-processing; stimulate new technical 
approaches; and accelerate the convergence of mini aturised technologies in response to user 
requests. 
NFFA :105 The Commission also su pports 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’ in frastructure 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 f acilities: synchrotron radi ation sources; neutron 
scattering sources; high power lasers, incl uding free electron lasers; high performance 
computing, and so on. The objective of such a cl uster is to enable researchers to access to 
state-of-the-art synthesis, na nofabrication and analysis tool s. 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 characteri sation for advanced experiments using leading 
edge facilities. 
Contribution of Networks of Excellence : Beyond the dedicated activities described above, 
several Networks of Excellence (NoEs) have c ontributed to infrastruc tures and training in 
nanotechnology. 
                                                 
104 http://www.euminafab.eu  
105 http://nffa.tasc.infm.it  
 
EN 42   EN The experience of the Nano2Life  NoE is expected to set the basis of a future European 
nanobiotechnology institute, focused on unde rstanding the nanoscale interface between 
biological and non-biological entiti es, 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 nanobiotec hnology is being explored thr ough a support action of FP7. 
The Nanoquanta  NoE addressed the quantum mechanics of nanosystems and led to the 
creation of a virtual infrastructure, the Eu ropean Theoretical Spectroscopy Facility ( ETSF ).106 
This provides computer codes and expertise fo r the analysis of the excited states of 
nanosystems, that is, their electronic and op tical properties, thereby supporting further 
research and industrial applications. ETSF ha s already attracted many users, including 
industrial ones. At the end of its funding under FP6 (NMP them atic priority), it was granted 
funding from the FP7 Capacities programme (e-Infrastructures). 
In the area of nanomaterials,  several NoEs have led to du rable integration. Examples are 
IDECAT in catalysis, INSIDE-PORES in na no-porous materials, and NANOFUN-POLY in 
polymer-based nanomaterials. 
Efforts of Member States : 
As described above, the PRINS pr oject 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 Gennesy s initiative bringing 
together European neutron and synchrotr on 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 nationa l 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 w ithin Europe to develop the 
measurement frame required for successful support to the development and economic 
exploitation of nanotechnology. Co-Nanomet’s activ ities focus on the nanometrology needs of 
European industry and are addressed throug h four key actions, one of which is the 
exploitation and developmen t of Infrastructures. 
                                                 
106 http://www.etsf.eu/  
107 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/websiteMetallfor schung/pdf/GENNESY S/GENNESYS_2009.pdf  
108 http://www.nano-map.de/results/map.php  
 
EN 43   EN Given the high level of investment in na notechnology capacity-build ing across Europe, a 
complementary pan-European view of orga nisations and associated capabilities in 
nanometrology is required. The Co-nanomet pr ogramme is reviewing current capability, 
which it will signpost to potenti al users; and will make reco mmendations for the development 
of new nanometrology infras tructures across Europe. 
NanoImpactNet109 is a similar coordination action in the area of risk assessment. It will 
facilitate collaboration betw een projects on the health a nd 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 de velopment of regulatory measures and 
implementation of legislation in Europe. 
An important future development is the inclusio n, 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 nanom aterials, 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 researcher s, 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 research ers 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 fundame ntal and applied research. 
Also necessary is an understanding of market  demands and the development of applications. 
This is another aspect of mobility, which s hould not only be geographical but also between 
disciplines and sectors. An e ffective programme for training a nd transfer of knowledge should 
be established. The importance of technological developmen t 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 ev idenced by a strong 
participation in EU-funded a nd other European activities. 
There has been significant support for trai ning in nanotechnology through the Marie Curie 
actions of FP6, with grants of EUR 161 milli on, some 8 % of the total budget (even though 
funds are not earmarked for any particular se ctor). Training activiti es in nanotechnology 
continue to receive funding under the People programme of FP7, with grants of EUR 125 
million in 2007 and 2008. 
                                                 
109 http://www.nanoimpactnet.eu/object_class/nano_men_home.html  
110 topic INFRA-2010-1.1.31 
111 Towards a European Research Area , COM(2000)6 
 
EN 44   EN Some examples of Marie Curie projects o ffering 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, nanostructu red metals and metal-oxide interfaces. 
MAMINA, MINILUBES and DENDREAMERS offer training in nanotribology and 
nanomechanics research, nanoscale surface char acterisation, nanoporous metallic materials 
and nanohybrid materials. 
FUNMOLS and SEMISPINNET offe r training in nanodevices . FUNMOLS also provides 
training in environmental, socio-econo mic and policy aspects of nanotechnology. 
FANTOMAS provides training in nano-opto-magnetis m, an emerging field at the interface of 
coherent non-linear optics, nanophotonics and nanomagnetism. 
BIOMINTEC provides trai ning in nanobiotechnology. 
HIERARCHY offers a broad training programme in nanos ciences 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 nanost ructures and nanoelectronics. 
NASCENT offers training in nanomaterials fo r applications in sensors and catalysis. 
COMSON offers training in simulati on 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 na nostructured superconductors. 
The training programmes of na notechnology-related Marie Curie projects address two major 
requirements for future researchers: First, rese archers 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 adequa te solutions to challenges that are raised in 
market-driven research. Nanotechnology-relate d Marie Curie projects provide complex and 
multidisciplinary research training with c ontributions from chemistry, physics, biology, 
materials science, mechanical engineering, op to-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 fo r television documentaries, articl es in newspapers or popular 
science magazines, and lect ures for non-specialists. Ma ny Marie Curie projects use 
opportunities to communicate their re search results in these ways. 
There are close links to the i nnovation efforts of European co mpanies: Industrial partners 
directly support the tr ansfer of the results into industr ial applications. Collaboration with 
 
EN 45   EN industry provides a way of focusing current research efforts, to f acilitate 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 industria l presence in networks, combined with the expertise of the 
academic host institutions in setting up spin-o ff 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 existe nce of separate scientific communities and the 
absence of thematic identity. Marie Curi e projects address the fragmentation in 
nanotechnology research, creating a coherent framework of rese arch, know-how and training 
between the various research communities, with the objective of achieving a lasting 
integration between the main Euro pean institutions in the area. 
Other Commission activities in education : 
The training activities funded by the Commis sion’s lifelong learning  programme and the 
corresponding international activities can s upport training in nanotechnology. So far, the 
Erasmus Mundus Programme has supported Master s degrees in three nanotechnology areas112 
(although there have been no new projects since 2007). Novel technologies including 
nanotechnology have been singled ou t 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-calle d Knowledge and Innovation Networks115 (KICs), which 
will constitute the EIC, covers climate change  mitigation and adaptation, sustainable energy 
and the future information and communication so ciety – 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 valu able contributions in this area. 
The Nano2Life  NoE, which addressed nanobiotechnology, involved 200 scientists, engineers 
and medical doctors. It contribut ed to training by bridging th e 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 infrastructu re, the European Theoretical Spectroscopy Facility (ETSF). It 
organised a total of eleven training schools, alon g with many more scie ntific conferences and 
workshops (including the innovative an nual Nanoquanta-ETSF Young Researchers’ 
Meeting). More than fifty PhD students were tr ained collaboratively with in the network’s own 
groups. 
The Nanobeams  project created a European PhD School  on characterisation techniques using 
ion and electron beams.
116 
                                                 
112 http://www.emm-nano.org/  
http://www.u-picar die.fr/mundus_MESC/  
http://www.ens-cachan.fr/monabiphot/  
113 New Skills for New Jobs - Anticipating and matching labour market and skills needs , COM(2008)868  
114 http://eit.europa.eu/  
115 http://eit.europa.eu/kics-call.html  
116 https://www.nanobeams.org/  
 
EN 46   EN Within the Nanoker  Integrated Project, three external training programmes will be 
developed,117 in biomaterials, optics and extreme c onditions. Their objectiv es 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 fiel ds of materials modelling, design, analytical and 
experimental methods, specific to understand ing the behaviour of materials under complex 
conditions; and (iii) to acquaint scientists an d engineers with new pr ocessing 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 ma in 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. Thes e 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 in tegrated circuit to replace ordinary components, 
or to form altogether novel devices that ca nnot 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 micr oscopy). This, in turn, will foster the long 
term objective of the project, to handle and asse mble 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 trai ning in nanoelectronics: To br idge the widening gap between 
the state of the art of European academia a nd that of leading industry, the IDESA support 
action develops training material on the de sign flow for integrat ed circuits employing 
advanced deep sub-micron technologies, and ma kes it available free of  intellectual property 
rights. The EUROPRACTICE suppor t action is widely recognise d 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 NanoSMILE
120 activities within the Nanosafe2 
project were designed to pr ovide information and training. These cover potential risks, 
exposure and dosimetry, and potential imp act 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 envir onmental hazards and impact assessment. 
Some European Technology Platforms include training in their activ ities: SusChem, for 
example, developed an “education database”,121 because the long-term success of the 
                                                 
117 http://www.nanoker-society.org/inde x.aspx?id_page=140&ID_Elemento=235  
118 http://www.nanoker-
society.org/index.aspx?ID_Page=158&ID= 365&ID_Plantilla=301&TIPO=asyContenido  
119 http://www.nanohand.eu  
120
 http://www.nanosafe.org/script s/home/publigen/content/templa tes/show.asp?P=68&L=EN&IT
EMID=19  
121 http://learning.suschem.org/  
 
EN 47   EN European chemical industry depends on attractin g and retaining the best students from school 
through to higher education. The objectives of this educati on 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 ca nnot 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 dem ographic change and emerging 
security needs, all of which call for collective action to safeguard the European way of life, which combines economic prosperity with soli darity. 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 we ll-being through more intelligen t infrastructure provision, the 
Commission is convinced that i nnovation in a broad sense is one of the main answers to 
people’s material concerns about their future. 
The European Union has an extraordinary inno vation potential. Europe  has a long-standing 
tradition of breakthrough inventi ons. It has a wealth of creativ e 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 la rge scale. It also has a 
tradition of a strong and res ponsible public sector, whic h should be capitalised on. 
4.1. General situation 
Notwithstanding the large public support for European nanotechnol ogy, private investment in 
nanotechnology R&D remains low compared to Eu rope’s main competitors (see section 1.1). 
In fact, the number of new nanotechnology compan ies 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 hi gher in North America 
than in Europe. Moreover, the majority of European nanotechnology companies, mainly 
located in Germany and the United Kingdom, are mu ch 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 Nort h 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 Ru ssian Federation in particular, are emerging in 
the field of nanotechnology. Although they may stil l lag behind on most indicators, they are in 
a position to expand and bridge the gap with Europe. They w ill probably become serious 
competitors on the world market and attractive locations for research activities. European 
industry has yet to build upon the strong a nd competitive European science base in 
nanotechnology and to increase its research effo rts. 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 activi ties from scientific results. This difficulty 
is revealed by the massive gap in Europe betw een the development of the science base and 
that of the nanotechnology industry. 
 
EN 48   EN Statistical data, including a general analys is 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 turn ing it into new products a nd services is crucial to 
maintain and enhance Europe’s competitivene ss. 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 hi ndering collaboration between 
research and industry. 
The Commission has a broa d innovation strategy.123 The 2006 Communication on innovation, 
“Putting knowledge into practice: A broa d-based innovation strategy for the EU”,124 points 
the way forward to accompany industry-le d and society-driven innovation with 
competitiveness and public policies at all levels, as a core element of the renewed Lisbon strategy for growth and jobs. The Communicati on singles out ten priority actions in a 
roadmap for action at the nationa l and European levels. These in clude an improved transfer of 
knowledge between public research  institutions and third parties,  including industry and civil 
society organisations.
 
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 St ates to develop new measures favouring the 
support of innovation, taking into account the id entified shortcomings in this domain. This 
should also encourage Member Stat es and regions to redirect st ate support, for instance from 
structural funds, towards activities that are mo st directly relevant to the Lisbon agenda. 
Other key documents on innovation policy are as follows: – Commission Recommendation on the management  of intellectual pr operty in knowledge 
transfer activities and Code  of Practice for universitie s and other public research 
organisations;
125 
– Commission Communication on Improving knowledge transf er 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 
                                                 
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 http://ec.europa.eu/enterprise/innovation/index_en.htm#2  
124 COM(2006)502; 
http://eur-lex.europa.eu/LexUriServ/LexU riServ.do?uri=COM:2006:0502:FIN:en:PDF  
125 C(2008)1329; 
http://ec.europa.eu/invest-in-research/pdf/ip_recommendation_en.pdf  
126 COM(2007)182; 
http://eur-lex.europa.eu/LexUriServ/LexU riServ.do?uri=COM:2007:0182:FIN:en:PDF  
127 SEC(2007)449; 
http://ec.europa.eu/invest-in-research/pdf/sec2007449_en.pdf  
 
EN 49   EN – Commission Communication on More  Research and Innovation - investing for growth and 
Employment: A Common Approach.128 
In response to a request from the Council Wo rking Party on Competitiveness and Growth, the 
Commission services prepared a Progress Repo rt 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 ec o-innovation), provide better access to finance and deliver business 
support services in the regions. It will encourage a be tter take-up and use of information and 
communications technologies and help to de velop the information society. It will also 
promote the increased use of renewable energies  and energy efficiency. The CIP is divided 
into three operational programmes: Entrepre neurship and Innovation Programme (EIP); 
Information Communication Technologies Policy Support Programme (ICT PSP); and 
Intelligent Energy Europe (IEE). Nanotechnologies ar e relevant to all th ree because of their 
enabling nature. 
When considering Community funding opport unities for research and innovation in 
nanotechnology, it is important to make the best use of the ex isting 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, entrepre neurship 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) unde r 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-sup porting since 2007. This network consists of 
over 220 Knowledge Transfer Offices (KTOs) an d 10 National Partner A ssociations. ProTon 
Europe reaches out to almost 600 universitie s and public research organisations across 
Europe. Activities addre ssing nanotechnology included the 2008 ProTon Europe Annual 
Conference, which helped form effective partne rships as an essential part of successful 
knowledge transfer deals. 
                                                 
128 COM(2005)488; 
http://eur-lex.europa.eu/LexUriServ/LexU riServ.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  
130 http://ec.europa.eu/regional_policy/atlas2007/index_en.htm  
131 http://www.protoneurope.org  
 
EN 50   EN Technology Innovation International (TII)132 is a wide network of innovation and 
technology transfer specialists, whose members provide support se rvices 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 as pires 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 fast er and better. It brin gs together providers 
of support on public and private innovation, such  as innovation agencies, technology transfer 
offices, business incubators, financing intermedia ries, cluster organisatio ns and others. Within 
Europe INNOVA, one can mention the Finn ish 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, learni ng 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 partic ular technology sectors 
This section deals with particular applica tion areas, outlining underlying technologies, their 
maturity, opportunities and risks. 
Recognising the fact that developments in nano materials will lead to ap plications 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 st age. Analyses of potential markets are often 
vague and inconsistent; nevertheless, market-rele vant applications can be expected in the 
fields of optics, precision engineering, analytics, chemistry, automotive and mechanical 
engineering, materials management and me dical 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 a nd application-driven research; funding for the 
development of marketable produc ts; and venture capital funds fo r 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 basi s and human resources. 
An example is the area of ceramics: An analysis  of the state of the ar t shows that realistic 
market opportunities exist for nanopowders, prim arily 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 hi gh temperatures and result in 
low defect tolerance of ceramic materials and pa rts – especially the high  brittleness – can be 
minimised. In this, as in other technologies, realising the market potential will only be 
                                                 
132 http://www.tii.org  
133 http://www.enterprise- europe-network.ec.europa.eu/index_en.htm  
134 http://www.europe-innova.org/index.jsp  
135 http://www.proin no-europe.eu/index.cfm? fuseaction=page.home  
136 http://www.nanoroad.net/downloa d/overview_nanomaterials.pdf  
 
EN 51   EN possible if the processes are controllable, the properties ar e reproducible and the production 
volumes are sufficiently high to make costs competitive. 
Further analyses of market opportunities are need ed. 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 op portunities and risks within a wide range of 
application sectors, and enabling them to unde rstand the potential and critical issues. The 
following technology sectors are covered: (1 ) Aerospace, Automotive and Transport; (2) 
Agrifood; (3) Chemistry and Materials; (4) C onstruction; (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 nanot echnology research, and opportunities for 
collaboration between researchers in the EU and International Coopera tion Partner Countries 
(ICPC), the Commission is also funding an ope n-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 nanot echnology in electronics  and photonics are 
described in sub-sec tions 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. Regi onal clusters with a high density of 
semiconductor industries are also the areas wi th the highest rate of patenting activity. 
Nanoelectronics can be defined as electronics on the deep subm icron level – that is, with 
circuit dimensions of less than 100 nm. The te rm covers both the manufacturing of ever-
smaller semiconductor devices, and advances in molecular electronics ex ploiting single atoms 
or molecules. Semiconductor chips with nanos cale features are al ready in production. The 
majority of electronic devices now consist of complementary metal oxide semiconductor 
(CMOS) circuits on silicon wafe rs, and there is much experien ce in their low-cost production. 
Because of its advantageous characteristics a nd future development pot ential, experts predict 
that CMOS will remain the ma instream technology for many years and improvements will 
continue until at least 2016. Short to medium-t erm 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 in cludes alternative schemes to en code information (new logic 
devices) to enable computing at low power consumption; inventi ng and developing new 
information processing technology; and mana ging heat transfer mo re efficiently through 
phonon technology. The current proce ss for integrated circuit fa brication – lithography – may 
be improved by immersion lithography, comput ational methods and extreme ultraviolet 
lithography. There are also a num ber of wholly new technologies  for nanoscale fabrication, 
including dip-pen lithography and nano imprint lithography. Efforts are made to develop a 
                                                 
137 http://www.observatorynano.eu/project/  
138 http://www.icpc-nanonet.org/  
 
EN 52   EN “universal memory”: one which exceeds the capac ity and cost effectiveness of flash memory, 
whilst maintaining its non-volatil ity, and improving on the data tr ansfer speed of conventional 
random access memory. A further impact of nanomaterials is in displays for televisions, portable devices, and other applications; orga nic LEDs (OLEDs) have already received much 
attention, but there are also efforts to produce thin-film tran sistors 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 de tection of biomolecules has resulted in a range 
of biochips for routine biomedi cal diagnosis and the mass screen ing 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 bioc hips 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 a nd 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 issu es 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; target ed drug delivery; coatings 
for implants and surgical instruments;  drug discovery; a nd tissue engineering. 
Many different nanomaterials are presently us ed in clinical or pre-clinical trials: 
– Nanoparticles with magnetic or supermagnetic  properties; titanium dioxide; iron oxide; 
proteins or peptides; gold; silver; fluorin e; manganese; functionalised metal; ligands. 
– Nanotubes (used as container for drug delivery). 
– Fullerenes (e.g. a modified fullerene is enteri ng clinical trials as an anti-HIV agent). 
– Quantum dots (e.g. cadmium selenide core su rrounded 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 NanoRoadSME project  
140 vision paper of the Nanomedicine ETP 
 
EN 53   EN – Nanobiotechnology-based drugs, with a nuc leus 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 addr essed by applications of nanomater ials in the energy sector are 
improvements in efficiency, product reliability, sa fety and lifetime, and the reduction of costs. 
Three application domains can be identified in this sector: (a) energy conversion and 
production; (b) energy storag e; and (c) energy saving. 
The most promising applications in energy  conversion are photovo ltaics (solar cells), 
hydrogen conversion (fuel cells), and thermoelectri city (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 ar e available. Cost reduction is expected from 
dye-sensistised solar cells and organic pol ymer solar cells. A lthough 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 wh ile 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 ther moelectric devices for recovering waste heat. 
For energy storage, the most pr omising developments relate to rechargeable batteries and 
supercapacitors. In rechargeable batteries (f or example lithium batteries), nanocrystalline 
materials and nanotubes used as electrode materi als 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, a dvances in supercapacitors are expected through 
the use of nanoporous electrode materials. Na notechnology will open new potential markets 
for batteries and supercapacitors, or combin ations of the two (e.g. in mobile phones and 
portable computers). 
Interesting energy-saving applicat ions are expected in the fields of insulation and efficient 
lighting. Advances in insula tion brought about by nanotechnol ogy will help reduce energy 
demand and the daily costs in hom es and industry. Such advances  will be aerogels or smart 
glazes in the form of ultra th in layers. In the field of mo re 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) 
 
EN 54   EN Some examples of nanomaterials used in the energy sector are: 
– Nanolayers, such as colloids, organic dye mol ecules, tungsten trioxide and zinc oxide, for 
aerogel and smart glass applications; 
– Indium gallium nitride for inorganic LEDs; 
– Organic nanolayers and nanostructured pol ymer films for small-molecule LEDs; 
– Metal oxide nanomaterials, nanoporous meta l 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 mu ch greater surface area. Various applications 
have been successfully demonstrated at the labo ratory scale, but most of them still require 
verification of efficacy and safety in the fiel d and are thus still far from market. Further 
research is also needed to assess the environm ental impact of the na noparticles 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 main tain 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 nanote chnology. From nanotubes in fuel lines, to 
nanoparticles in scratch-resistan t 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-e ffective production technologies and better 
characterisation tools and pr ocess control (e.g. PVD and CV D processes for coatings). 
For paints and coatings, the properties of tradi tional 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 a nd conductive capabilities. 
Paints and coatings industries were among the fi rst to take advantage of these capabilities 
three to five years ago. Coati ngs incorporating nanoparticles ar e smoother, stronger, and more 
durable, with only small differen ces in cost. (More generally, na nomaterials are being widely 
incorporated in coatings, to obtain results ranging from scratc h-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 cooli ng fluids and ferrofluids. 
Iron-based nanomaterials injected into certain fluids can be used for suspension and braking 
systems, as their viscosisty can be ch anged 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 frie ndly and wear resistant; 
New nanocoatings can reduce weight, improve pr essure retention and reduce recycling and 
incineration costs. In the past few years, Eu ropean producers of elastomers and inorganic 
oxides have teamed to produce a green tyre, ba sed on hydrocarbon elastomers reinforced with 
nanostructured silicon dioxide. 
 
EN 55   EN 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 tr eatments are likely to continue to be the 
fastest growing sectors both in vehicle part s, and in tooling and production equipment. 
Coating technologies are more mature, can bene fit from developments in other sectors and 
can offer clear benefits in the short term (e.g. increased tooling lifetime). 
Eventually, the automotive industry should be nefit from nanotechnology developments in 
energy applications. In principle, almost all automotive components can be improved by 
nanotechnology. Furthermore, the automotive i ndustry 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 component s; coatings and pa ints; engines and engine components; 
interior equipment and furnishing. 
Nanomaterials presently used include: na nopowders; epoxy matrix es with carbon fibre 
reinforcements; and ceramics (metallic oxides,  nitrides and carbides)  for coatings – e.g. 
zirconium oxide in combination with yttrium ox ide is used in coatings and components for 
gas turbines and jet engines. 
No nanomaterials are as yet in industrial us e for engines and engine components, although 
potential applications have been identified fo r organic matrix composites and ceramic matrix 
composites in linings, paints, sensors and act uators. These are exp ected to result in 
enhancements of mechanical properties. Polyme r conductors and ceramics are also likely to 
permit the modification of certain physical proper ties, 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 emi ssions. Therefore, energy-efficient buildings 
will be crucial for environmenta lly sustainable development. In  this regard, nanotechnology 
offers several pathways for significant improve ments in thermal isolation and reductions in 
greenhouse emissions. 
Increasing the strength and durability of materi als 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 app lication to construction are silicon dioxide and 
titanium dioxide. Silicon dioxide is the most  common nanomaterial in today’s construction 
industry – in terms of producti on volume per year. This is be ing 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 al so 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 stre ngthen and monitor concre te. Cost factors and 
the relatively small number of practical applicat ions are preventing deve lopments, at present. 
Nevertheless, the construction sect or is expected to benefit indi rectly from advances in other 
sectors where CNTs are of interest. 
 
EN 56   EN 4.3.8.  Nanomaterials for the Textile Sector 
The ETP for the Future of Textiles and Clot hing has developed a vision for the very large 
market in textiles, based on three trends:142 
– Development of new speciality fibres and fi bre composites (and environmentally friendly 
processes) for innovative textile products, to move from commodities to specialties; 
– Development of new textile products for i nnovative technical applications and “smart” 
textiles and clothing, to allow new applications; 
– Implementation of new design and product deve lopment concepts, integrated quality and 
life cycle management, to offer customisation for clothing and fashion. 
Nanotechnology can play a role in all three trends; ther e 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, hydr ophilic or hydrophobic properties  and antistatic features. 
These materials can be used for a large va riety of applications , including sportswear, 
protective clothing and packaging.  Products with some of these features are al ready finding 
their way on the market. The s econd, 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 di oxide and zinc oxide are most  widespread, and are highly 
effective as UV (ultraviolet) filters in sunscreens. Nanotech nology-based materials (so-called 
bio-composites) in toothpaste promote the natural tooth repair mechanism of saliva. In care products, nanocapsules protect and transport ac tive ingredients and e nhance 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 tran sparency) of finished cosmetic products by 
using nanomaterials. 
Common active ingredients used in cosmetic form ulations, 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 impo rtant, because they 
can improve the stability of the cosmetic fo rmulation 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 di oxide 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 radiat ion, while absorbing strongly in the UV region.  
Fullerenes (C
60) are reported to be used in a numb er of cosmetic products, including face 
creams. Vesicular systems, including liposomes , have been incorporated in many cosmetic 
formulations. Liposomes are colloidal partic les, typically consis ting of phospholipids and 
cholesterol. The lipid molecules form bi-lay ers 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, whereb y vesicles allow accumulation of ingredients 
in the stratum corneum or other outer layers of the skin. It is  unknown to what extent quantum 
                                                 
142 http://textile-platform.eu/textile-platform/?page_name=Vision  
 
EN 57   EN 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 revolutioni se the agricultural and food 
industry, with new tools for the molecular trea tment of diseases, rapid disease detection, 
enhancing the ability of plan ts 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 thro ugh the use of alternative energy supplies, and 
filters or catalysts to reduce pollution and clean-up existing pollutants. 
Controlled Environment Agricultu re (CEA) is a widely used me thod, which relies on modern 
technology for crop management. This is an a dvanced and intensive form of hydroponically-
based agriculture. Plants are gr own within a controll ed environment, so that horticultural 
practices can be optimised. A computerised system monitors and regulates localised 
environments, such as fields of crops. CE A technology, as it exists  today, provides an 
excellent platform for the introduction of na notechnology to agriculture. With many of the 
monitoring and control systems already in pl ace, nanotechnology-based devices that provide 
“scouting” capabilities could si gnificantly improve the grower’s ability to determine the best 
time of harvest for the crop, the vitality of the cr op, and food safety issues, such as microbial 
or chemical contamination. Nanobiotechnology-bas ed sensors will lead to equipment of 
increased sensitivity, allowing an earlier response to environmental changes. For example, nanosensors using carbon nanotube s or nano-cantilevers are sma ll enough to trap and measure 
individual proteins; and nanomaterials or na nosurfaces 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 productiv ity in agri culture by 
providing accurate information, thus help ing farmers to make better decisions. 
Some developments in nanomedicine will al so be relevant to  animal diseases. 
Nanotechnology can also be used to clean groun d 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 cyst s from water. Other ex amples include water 
purification techniques using sp ecific nanofiltration technologies with holes of 100 nm in size. 
Some companies are working on water filtratio n by making use of lanthanum nanoparticles 
that absorb phosphates from aqueous environmen ts. Applying these effectively, for instance 
in aquaculture ponds, removes av ailable phosphates and as a re sult 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 dependi ng 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 activi ties related to enhanci ng the nutritional quality 
of food through selected additives, and improve ments in the way in which the body digests 
and absorbs food. 
 
EN 58   EN 4.4. Standardisation and Metrology 
4.4.1.  Introduction 
Standardisation (the process of developi ng and agreeing upon techni cal standards) and 
metrology (the science of measurements and its  application) are two separate areas with 
several overlapping aspects. 
Metrology goes beyond standardisa tion, as it investigates and develops the concepts and 
approaches that can make measurement re sults 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 resu lts more reliable and robust. However, in 
several new or complex measurement fields, su ch 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 measur ement results are method-dependent. Thus 
metrology relies on standardisation in the deve lopment 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, produc ts 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 understandi ng of some of the issues of measurement at the nanoscale. 
In terms of research and innovation, the follow ing 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 im portant driver of innovation,143 as they provide legal certainty 
for innovative companies, help in creating la rge-scale markets and in building confidence 
among consumers. They influence the innovati on process through “p ath dependency”; in 
other words, when technical specifications ar e defined, the options for future technological 
developments are by definition narrowed, since le ss 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 foll ow-up activities outlined here, including the 
acceleration of standard-setting and the relationship between IPR and standards, since these 
are of relevance to acces s to standardisation. Lessons are also  learnt from the standardisation 
projects within the Europe INNOVA initiati ve (see section 4.2 above). The aim of the 
Standards Networks145 in Europe INNOVA is to demonstr ate in practice how standards can 
enhance innovation in Europe. These will also be  an issue in some of the new platforms in 
                                                 
143 http://ec.europa.eu/enterprise/policies/innovation/policy/standards/index_en.htm  
144 COM(2008)133; 
http://eur-lex.europa.eu/LexUriServ/LexU riServ.do?uri=COM:2008:0133:FIN:en:PDF  
145 http://standards.eu-innova.org/  
 
EN 59   EN Phase 2 of Europe INNOVA. In the particular fi eld 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 standardis ation can make toward s developing innovation 
and competitiveness, by facilitating access to mark ets, enabling interoperability between new 
and existing products, services and processe s, enhancing protection of users, giving 
consumers confidence in innovations and dissemina ting research results”. In order to address 
this challenge, the CEN and CENELEC Techni cal 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 re search 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 contri bute as effectively as 
possible to their implementation. The STAIR Gr oup 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 wi ll also review the existing CEN-CENELEC 
documentation on R&D and standardisation and de velop new guidance mate rial 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. Th e 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 addr ess all these challenges (the integrated 
approach, the production of guidelines, the orga nisation of seminars and conferences, and so 
on) in the short to medium term, and should th erefore 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 Comm ittees CEN/TC 352 and ISO/TC 229, both 
initiated in 2005, became fully operational. Seve ral EU national bodies contribute to the ISO 
work (thirteen EU countries are Participa ting Members, and three more are Observing 
Members). Industry associations as well as consumer organisations have become liaison 
members. The Commission’s Joint Research Ce ntre is very actively involved as a liaison 
member in both Technical Committees. 
To avoid duplication, and because of the glob al 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 cont ribution to the development of ISO standards 
                                                
 
146 http://ec.europa.eu/enterprise/ict/policy/standards/ws08ipr_en.htm  
147 http://www.cen.eu/cenorm/workarea/ advisory+bodies/stair/index.asp  
 
EN 60   EN via CEN is, incidentally, one way of involvi ng in the nanotechnologi es 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); measurem ent and characterisation (JWG2); health, 
safety and environmental aspects of nanotechno logies (WG3); and materials specifications 
(WG4). The following available outputs are noted here: 
– ISO/TR 12885:2008: Health and sa fety practices in occupational settings relevant to 
nanotechnologies 
– ISO/TS 27687:2008: Terminology and definiti ons for nano-objects – Nanoparticle, 
nanofibre and nanoplate 
The following documents are in the final appr oval stages and will be available soon: 
– ISO 10808: Characterisation of nanoparticle s in inhalation exposure chambers for 
inhalation toxicity testing 
– ISO TS 11251: Characterisa tion of single-wall carbon na notubes using evolved gas 
analysis-gas chromatograph mass spectrometry 
– ISO TS 10868: Nanotubes – Characterisatio n of single-wall carbon nanotubes using 
ultraviolet, visible and near infrared spectroscopy 
– ISO TR 80004-1: Terminology – Fr amework for core concepts 
– ISO TS 80004-4: Terminology and de finitions 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 knowle dge gaps in the HSE area: 
– ISO 12025: General Framework for Determini ng Nanoparticle Content in Nanomaterials 
by Generation of Aerosols 
– ISO TR 13329: Preparation of Material Safe ty Data Sheet (MSDS) for nanomaterials 
– ISO TS 14101: Surface characterisation of go ld nanoparticles for nanomaterial specific 
toxicity screening: FT-IR method 
– ISO TS 12901-1: Guidance on safe handling an d disposal of manufactured nanomaterials 
– ISO TR 13014: Guidance on physicochemical ch aracterisation of en gineered nanoscale 
materials for toxicological assessment 
– ISO TS 13278: Carbon nanotubes – Determination of metal im purities 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 22 9 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 “G uide to nanoparticle measurement methods and 
                                                 
148 http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983  
 
EN 61   EN their limitations”; a “Guide to methods for na notribology measurements”; and a “Guide to 
labelling of manufactured na noparticles and products contai ning 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 CE N TCs, which have been dealing with 
nanotechnology-related standards for many years, in particular, but not only, the measurement 
and characterisation of particle s and materials microstructures. Among the more than thirty 
current liaison members of IS O/TC 229, are ISO/TC 24 (particl e characterisation); ISO/TC 
146 (air quality); ISO/TC 201 (surface chemical an alysis); ISO/TC 202 (microbeam analysis); 
ISO/TC 209 (clean rooms and associated environments); ISO/REMCO (ISO Reference 
Materials Committee); and also the OECD, th e IUPAC and the IEC. These TCs and other 
organisations have an interest in the deve lopment of nanotechnology-related standards, and 
meet twice a year in the Nanotechnologies Li aisons Coordination Group (NLCG), which was 
initiated after the internati onal workshop of ISO, IEC, NIST and OECD on documentary 
standards for measurement and characteri sation 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 orga nisations in the field 
of nanotechnologies and to identify crosscuttin g gaps and opportunities and ways to address 
these.” 
Among all ISO standardisation committees, the IS O/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 prop erties such as dispersion 
stability and zeta-potential measurements. 
4.4.4.  Plans for future standardisation activit ies: The CEN report to the Commission’s 
programming mandate and the Commission’s response 
In May 2008, the CEN/TC 352 Mandate Report Gr oup submitted a report to the Commission 
on its Mandate addressed to CEN, CENELEC an d 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 extens ive review of CEN a nd CENELEC Technical 
Committees (TCs), European Technology Pl atforms (ETPs) and organisations and 
associations with a possible interest in na notechnology. It was unde rtaken in order to 
determine the level of interest or activity by th ese 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 identificatio n of standardisation need s performed within the 
EU-funded Nanostrand project. Moreover, EU -funded projects in nanotechnology were 
recently scanned to identify any research acti vity 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 
 
EN 62   EN – Toxicology and safety 
EU-funded projects in these areas are encouraged to develop and implement active 
standardisation policies. Other pr ojects, large ones in particular , are including standardisation 
efforts in their work plans. The picture pres ented 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 comprehe nsive 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 unde rstanding of the role 
that standards deliverables can play in s upporting the existing an d 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) healt h, worker and environmental safe ty; (ii) the Lisbon agenda; and 
(iii) the societal agenda. The standards deliverabl es 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, th ere should be clos e cooperation between 
CEN/CENELEC and ISO/IEC, and there is sc ope 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 colla boration between the na notechnology TCs of CEN 
and ISO (CEN/TC 352 and ISO/TC 229). Ind eed, the standardisation programme is 
potentially so large that all available standa rdisation resources should be embraced. There is 
likely to be a considerable level of as yet untapped technical e xpertise in Europe that can be 
used in the area of standardisation. The leve l of participation in standards activity in 
CEN/TC 352 is currently not fully representati ve of known stakeholde rs, comprising mostly 
national standards bodies, national metrology ins titutes, and a few universities and research 
establishments. The European standards bodies make the following recommendations: 
(1) A group should be established to focu s on the opportunities and needs for 
nanotechnology standardisation that can aris e, for example, within ETPs and EU-
funded projects. Membership of such a gr oup should be representa tive of relevant 
stakeholders, including TCs and other structures within CEN, CENELEC and ETSI. 
(2) The Commission should require  that funded projects consid er, where applicable, how 
their project work can be translated into appropriate standards. The outcome of this 
consideration should be a project deliverable. 
(3) A programme of standardisation, as describe d in the report, should be initiated, by 
means of a standardisation mandate to CE N, CENELEC and ETSI, to encourage the 
development of nanotechnology-specific standa rds in Europe, and the participation of 
European stakeholders in the European standardisation process. 
(4) The Commission should provide clear guidan ce as to what standards projects are 
needed to support existing or future legislation. 
 
EN 63   EN (5) Additional incentives should be provided fo r stakeholders to participate in the 
nanotechnology standardisation process,  for instance through the provision of 
straightforward means of funding participa tion in standards committee meetings, in 
particular those dealing with, and propos ing, New Work Items corresponding to the 
list of required standards listed in this report. 
(6) 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 enha nce the links between CEN (e.g. 
TC 352) and relevant EU-funded projects, to en sure that the pre-and co-normative research 
work is finding its way into standards and technical specifications. 
With regard to the preparation of specific st andardisation mandates, a preliminary conclusion 
is that the activities of CE N (e.g. TC 352) should focus on pr oducing documentary standards 
in the fields of nomenclatu re (definitions of nanotechnology- specific terms, materials 
nomenclature based on nanomaterial structures ); characterisation (general guidance on the 
relevance and limitations of measuring specif ic 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 environmen t); and simulation methodologies (simulation 
of possible workplace, consumer and environm ent exposure). The simulation of exposure in 
particular was not explicitly included in the repo rt, but is already part of the ISO/TC 229 work 
programme; recent research activities and publi cations 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 co nclusion 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 standardis ation outputs into the 
OECD-WPMN activities and ensure  a good synergy between all re levant 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 resear ch, and tools for measurement quality 
assurance 
Measurement methods with nanom etre-resolution and methods a pplicable to the assessment 
of nanoparticles and nanostructu red materials are often still under development. The area is 
research-intensive, because of the many ambigu ities in nanomaterials work. In the specific 
case of nanoparticles, it is, fo r example, not yet generally realised that particle size 
distribution is not a fundamenta l property of the material bei ng 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 wo rkable 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 instru ments and techniques, 
which, once developed, will need validation and veri fication. This is the topic of pre- and co-
 
EN 64   EN normative research, which is performed in indust rial research projects (such as FP7) or in 
collaborative organisations, such as VAMAS (t he Versailles project on Advanced Materials 
and Standards, established in 1982 as one of 18 cooperative projects intended to stimulate 
trade in new technologies usi ng advanced materials, through pre-standardisation research).149 
In VAMAS, work is undertaken in Technica l Working Areas (TWAs), two of which are 
directly relevant to nanotec hnologies – TWA 29, nanomechan ics applied to SPM, and TWA 
33, polymer nanocomposites. Thes e have now been complemented by the establishment of a 
new TWA on the characterisation of nanopartic le populations, with projects on airborne 
nanoparticles, on multiwall carbon nanotubes,  and on nanostructured titanium dioxide. 
VAMAS can provide the outcomes of its pre-norm ative and co-normative research directly to 
the ISO standardisation process. To reflect the globalisation of materials research, the 
VAMAS membership is now wider, with th e founding members – Canada, France, Germany, 
Italy, Japan, UK, USA and the European Co mmission – joined by Korea, Taiwan, South 
Africa, Mexico, Australia, Brazil and India between 2007 and 2009. 
The relevance of pre- and co-normative rese arch for measurement standards has been 
emphasised by the adoption of a metrol ogical check-list in  ISO/TC 229/JWG 2.150 This 
document was developed at the JRC and is be ginning to provide more structure to the 
TC 229/JWG 2 work programme. The developm ent and dissemination of proper metrology 
concepts in the nanotechnology arena is also th e aim of the recently st arted EU-funded project 
Co-Nanomet,151 with partners from eight EU countri es as well as the JRC. A first Co-
Nanomet workshop on the issue of standard s 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 activit y relevant to nanotechnology al so launched in 2008, as the 
European Association of National Metrology In stitutes (EURAMET), has become responsible 
for the development and execution of the Eur opean Metrology Research Programme (EMRP), 
an Article 169 initiative.152 Within the current activities of national metrology institutes, much 
research is being done on nanoscale measurem ents, which is of di rect relevance to 
standardisation in nanotechnologi es. It is important to ensu re 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 re ference materials was already mentioned.153 The 
development of reference materials, and their ro le in the development of new test protocols 
for the assessment of potential hazards, wa s a subject in the NanoImpactNet Workshop on 
standardisation of materials a nd 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 infrastructu re required for implementation of regulation. 
                                                 
149 http://www.vamas.org/  
150 ISO/TC 229/JWG2_N095rev1, “Metrological check-list for use in the preparation and evaluation of 
ISO NWIPs and ISO WDs” 
151 http://www.co-nanomet.eu  
152 Article 169 of the EC Treaty enables the Community to participate in resear ch programmes undertaken 
jointly by several Member States, including participa tion in the structures creat ed for the execution of 
national programmes. 
153 Section 1.3 and JRC, http://irmm.jrc.ec.europa.eu  
 
EN 65   EN 4.5. Patents 
The following conclusions on nanotechnology patents can be drawn:154 (i) inventive activities 
in nanotechnology have been gathering moment um since the late 1990s; (ii) nanotechnology 
is a set of technologies on the nanometre scale, rather than a single t echnological field; (iii) 
higher education and government sectors are im portant knowledge sources; (iv) science is the 
driving force of nanotechnology; (v) the numbe r of forward citations to nanotechnology 
patent applications suggests their high te chnological 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” a nd “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 developmen ts. 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 te chnology transfer, with 
special attention to resear ch institutions and SMEs. 
4.6. OECD Working Party on Nanotechnology (WPN) 
At the international level, innovation is addr essed by the OECD Committ ee on Scientific and 
Technological Policy (CSTP). Under th e 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 respon sible development of  nanotechnology. This 
work, together with the activities of the OECD Working Pa rty 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 si x 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 comparab le and validated indicators and statistics to 
monitor nanotechnology developments for policy needs.158 Data on research spending, 
publications and patents have be en collected. These show the si gnificant 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 dominan ce in terms of applications of nanomaterials 
and nanoelectronics, followed by nanobiotec hnology; and the rapid emergence of new 
players. 
                                                 
154 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  
155 reference not available at the time of writing 
156 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  
157 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. 
158 Report “Nanotechnology: An Overview Based on Indicators and Statistics” 
 
EN 66   EN Project B – Companies and the business environm ent: Complements the statistical work with 
a set of company case studies across different a pplication areas and countries. It analyses the 
impacts and business environment of nanotech nology and the challenges for business in 
developing, adopting and co mmercialising 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; li nks 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 questionnair es and country case st udies. This project 
surveyed challenges and prac tices 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: Re viewing national policy appro aches to the responsible 
development of nanotechnology.
160 A questionnaire collected information on nanotechnology 
policies from OECD Member Countr ies and the European Commission. 
Project F – Global challenges (water): In th e first instance, this project focused on the 
contribution of nanotechnology to th e 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 Chal lenges: Water and Nanotechnology”, outlining 
technologies for purification and management , which include membrane technologies and 
catalysts. The application of na notechnology to water is in fact growing more rapidly than the 
two wider sectors (nanotec hnology 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 deve lopment of policy. The si x project areas are: 
(1) Statistical framework for nanotechnology; 
(2) Monitoring and benchmarking nanotechnology developments; 
(3) Addressing challenges in the business e nvironment specific to nanotechnology; 
(4) Fostering nanotechnology to address global challenges; 
(5) Fostering international scientific co-operation in nanotechnology; and 
(6) Policy roundtables on key policy is sues related to nanotechnology. 
In the context of addressing global challe nges, a conference on pot ential environmental 
benefits was organised jointly with OECD-WPMN (the OECD Working Party on 
Manufactured Nanomaterials), with Commissi on and US funding. The “O ECD Conference on 
Potential Environmental Benefits of Nanotechnol ogy: Fostering Safe Innovation-led Growth”, 
which took place in Pa ris on 15-17 July 2009,162 covered both the op portunities and the 
                                                 
159 Report “Nanotechnology: Impacts on Companies, Business Environments and Policy”  
160 Report “Policy Dialogue – Progress Report and Questionnaire Findings” 
161 Report “Global Challenges: Water” 
162 OECD Conference on Potential Environmental Benef its 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  
 
EN 67   EN challenges of the use of nanotechnologies for poten tial environmental benefit. It is seen as a 
first milestone in collecting the information and de veloping the tools, whic h 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 shor t-term and long-term economic growth can be pursued. This 
provided an opportunity for governments, academia  and industry to consid er the state-of-the-
art of nanotechnologies, their potential to bring e nvironmental benefits, and, at the same time, 
concerns regarding human hea lth and environmental safety. In particular, the conference 
addressed sustainability and lif e cycle aspects in a variety of  sectors in which nanotechnology 
has the potential to give rise to environmen tal benefits. Thus, the conference explored the 
environmental profiles of emerging nanoscal e 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 conserva tion; catalysis; cleaner production; water 
treatment and purification; wate r and soil remediation; novel e nvironmental sensor techniques 
using nanotechnologies and monitoring devices measuring nanomaterials; and solutions based 
on sustainable chemistry, including s ynthesis and processing of chemicals. 
A policy roundtable on “International Scient ific 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 publis h 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 we ll as potential risks a nd any required measures, 
must be fully and accurately presented, and public  debate must be encouraged, to help people 
form an independent view. An e ffective dialogue with all stake holders 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 nanosc iences and nanotechnologies research 
In February 2008 the Commission adopted a recommendation for a “Code of Conduct for 
responsible nanosciences a nd 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 prin ciples and guidelines that Member States, and ultimately all 
stakeholders in the field of research, are in vited to adopt and prom ote. Council Conclusions 
on the recommendation were adopted in September 2008. 
The Code of Conduct is voluntary and complement ary to existing regula tions. It does not limit 
or otherwise affect the right of  Member States to grant a wi der measure of protection with 
regard to nanosciences and nanotechnologies research. The Code will be monitored and 
revised every two years by th e Commission in order to ta ke into account worldwide 
developments in nanotechnology and thei r integration in European society. 
                                                                                                                                                         
and http://www.oecd.org/dataoecd/6/1/43284399.pdf  
163 Commission Recommendation on a Code of Conduct for responsible nanosciences and 
nanotechnologies research , C(2008)424; 
http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=OJ:L:2008:116:0046:0052:EN:PDF  
 
EN 68   EN A first international conference on the Reco mmendation of the European Commission on a 
code of conduct for responsible nanosciences and nanotechnologies res earch 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 “Responsib le Care Global Charter 2006”;164 the Responsible Nano 
Code165 developed by the Royal Society with other partners; an d 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 standa rds to guide decisions 
in nanotechnology fields. In doing s o, it has taken into account the principle of respect for the 
rights of individuals, re spect for multiculturalism, dialogue and tolerance. These standards 
inform the ethical evaluation of new technol ogies 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 Eu ropean 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 cas e. 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 wh ere appropriate. These reviews are conducted 
by dedicated panels of specialis t independent evaluators, and ar e separate from the standard 
proposal evaluations. A sizeab le 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 projec ts were not in fact specific to nanotechnology 
(they involved animal testing, clin ical trials and other tests on humans, and research involving 
human genetic material), it appears that proposer s 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 starte d in 2009, to support decision 
making in the area of nanomedicine, with regard  to ethics, regulation an d societal acceptance. 
Very promising as it is, nanomedicine may a dd new dimensions to ethical, social and 
economic issues. It is therefore of primary importance to unde rstand the possible impacts of 
nanomedicine in advance. It is also importa nt to provide all stakeholders with a well-
organised forum to express their needs and requ irements, 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 scenario s on the possible consequences 
                                                 
164 http://www.cefic.be/Files/Publi cations/RC_GlobalCharter2006.pdf  
165 http://www.responsiblenanocode.org/  
166 http://nanoriskframework.com/page.cfm?tagID=1095  
167 (Recital 30) and article 6 of decision on FP7 
168 http://www.nanomedroundtable.org/  
 
EN 69   EN and impacts of nanomedicine. A further ai m is to raise awareness and promote an 
understanding of the field among policy makers and the wider public, a nd 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 a nd public debate on nanotechnology in Europe. 
The support actions and research projects under the Science in Society programme mobilise 
stakeholders and facilitate th e building of consensus for pr ospective research and policy 
options in this domain. 
The FP6 project DEEPEN ,
169 Deepening Ethical Engagement a nd Participation in Emerging 
Nanotechnologies , was set up to develop an integrated understanding of the ethical challenges 
posed by emerging nanotechnologies in real worl d 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 e nvironmental and occupational health and safety risks, and 
ethical aspects of nanotechnology. It organised a structured discussion between environmental 
NGOs, trade unions, academic researchers and othe r 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 po sition on the responsible development of 
nanotechnology, and the European Trade Un ion Confederation adopted a resolution 
representing 60 million workers in Europe. 
The FP7 project NANOPLAT
171 will create a forum on nanotechnology-based consumer 
products, and evaluate various in struments 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 protectio n of animals used for 
scientific purposes, and Regulations on REAC H and cosmetics, call for the promotion of 
alternative testing and the refinement, reduc tion or replacement of animal testing. The 
cosmetics legislation in particular has prohib ited the use of animal testing for cosmetics 
formulations since 2004; and of acute toxicity  tests for ingredient s since March 2009. The 
complete ban on animal testing, also for long-term toxicity stud ies, will come into force in 
March 2013. In REACH, the promotion of alternat ives to animal testin g is one of the main 
aims of the legislation; its implementation w ill take place in the new testing proposals and 
their evaluation in the European Chemi cals Agency (ECHA). The Commission has 
established a partnership with industry, is funding research into  alternative testing methods, 
                                                 
169
 http://www.geography.dur .ac.uk/Projects/Default.aspx?alias =www.geography.dur.ac.uk/projec
ts/deepen  
170 http://www.nanocap.eu/Flex/Site/   
171 www.nanoplat.org  
172 www.framingnano.eu  
 
EN 70   EN hosts the European Centre for Validation of Alternative Methods (ECVAM), and also works 
on this front in the context of the OECD. De tails 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 as pects of nanomedicine on 17 January 2007,173 the EGE 
may be requested in the future to extend it s work to broader nanotechnology issues, on the 
ethics of nanotechnology for human enhancemen t, biosecurity and military purposes. The 
EGE is currently working on an opinion on s ynthetic biology, which is also relevant. 
The Commission also participated in the reflexion of UNESCO’s World Commission on 
Ethics of Scientific Knowle dge and Technology (COMEST), wh ich 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, includi ng nanomaterials. The Commission considers 
that dialogue is indispensable for emerging t echnologies 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 br oad dialogues on nanotec hnologies, as well as 
numerous other outreach activities. These events  have involved public au thorities, scientists, 
industry associations, consumers, and environmental and other non-governmental 
organisations. Their coverage complements va rious 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 ac tivities detailed later in this section, as well as the activities 
on ethics and governance descri bed above, show a need for a more permanent public and 
policy deliberation on nanot echnologies in their br oad 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, re sulting in the funding of four projects 
which started in 2009, with a combined EU contribution around EUR 5 million. 
                                                 
173 The EGE is an independent, multidisciplinary an d 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. 
174 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  
175 e.g. a Eurobarometer survey, 
http://www.ec.europa.eu/research/press/2006/pdf /pr1906_eb_64_3_final_report-may2006_en.pdf  
176 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 
 
EN 71   EN – The NANO-TV project177 will raise the public awareness of European nanotechnology 
research, through visual media a nd 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 cha nnels. All VNRs will be made available on the 
European Research Media Centre website.
178 Key nanotechnology applications will be 
presented, addressing possible be nefits and implications. The vi deos and associated written 
material should support a sound, science-ba sed dialogue. Around fort y major television 
networks are expected to broad cast the videos from 2010 onwards. 
– The NANOTOTOUCH project aims to create  innovative environments, in which broad 
audiences can learn about and discuss nanotec hnology, by bringing researchers into contact 
with the public. Three science museums and three science centres will cooperate closely 
with local universities to create three pe rmanent “Open Nano-lab” centres (in Munich, 
Milan and Gothenburg) and thr ee “Nano Researcher Live” ar eas (in Mechelen, Tartu and 
Naples). Here, the visitors will experi ence 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 communicati on 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 a nd museums around Europe; and reach a much 
wider audience through its portal. The progr amme will combine temporary exhibitions, 
innovative computer games, experiments and ot her on-line content. Th ree main application 
areas of nanotechnology (nanomedicine, ener gy and environment, and ICT) will be 
addressed. 
– The TIMEFORNANO project180 aims to engage the genera l public, and young people in 
particular, in discussions on the benef its and potential risks associated with 
nanotechnology; and to collect op inions and feedback from th e participants. The products 
will use an enquiry-based learning approach, specifically developed in science centres and 
museums, where people understand by doing. Th e project will develop a number of 
informal education products: An interactiv e nano-kit for student groups; a yearly web 
contest for youngsters with  an artistic approach; and “nan o-days”, events and debates for 
the public at the partic ipating science centres. 
Additionally, NanoImpactNet, th e 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 stak eholders and the Commission, while at the same 
time obtaining input from the stakeholde rs about their needs and concerns. 
                                                 
177 http://www.nano.org.uk/news /feb2009/latest1786.htm  
178 http://www.youris.com  
179 http://www.nanoyou.eu/  
180 http://www.timefornano .eu/timefornanoeu/  
181 http://www.nanoimpactnet.eu/object_class/nano_men_home.html  
 
EN 72   EN 5.3.2.  Commission workshops on communication and outreach 
In 2007 the Commission organised two works hops on communication and outreach in 
nanotechnology, with an inte rcalated open consultation.182 The workshops involved experts 
from the fields of philosophy and sociology of  science and science communication; science 
centres; and artists a nd 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 c hoices, with regard to developments. 
– Ensuring access to reliable and high-quality information on ethical,  social and legal 
dimensions of nanotechnology and their po tential 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 intent ion 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 vi deo tells the story of a young girl who is 
discovering the usefulness of na notechnology-based products in da ily life, through interviews 
with the Nobel Prize winner Ha rry Kroto and other experts. 
Undoubtedly, scientists have a role  to play in explaining the pr inciples and applications of 
nanotechnology to the general public and the pr ess. To support them in public outreach, the 
Commission has made availa ble the handbook “Communicating Science – a Scientist’s 
Survival Kit”.185 
Finally, to ensure maximum transparency, th e 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 leve l are important, the 
Commission itself maintains an active policy of engagement and consultation. In particular, it 
invites stakeholders to particip ate on a continuous basis in th e regulatory work, and organised 
                                                 
182 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. 
183 ftp://ftp.cordis.eu ropa.eu/pub/nanotechno logy/docs/nanooutreach_ac tion_final_mar_08.doc  
184 The first, Nano: The Next Dimension  (2002), addressed a young public, while the second, 
Nanotechnology (2003), targeted audiences generally interested in science and technology. 
185 http://ec.europa.eu/research/science-so ciety/pdf/communicating-science_en.pdf  
186 ec.europa.eu/nanotechnology  
 
EN 73   EN the First and Second Nanotechnology “S afety for Success Dialogues”, in 2007187 and 2008188 
respectively. 
Stakeholders take part as obs ervers in Commission working gr oups in charge of coordinating 
the implementation of regulation. Examples in clude 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 s hown the need for increased coordination 
and more exchanges between Member States, re gulatory bodies and stake holders. In addition, 
the 2008 workshop led to the adoption of te n action points. The “Safety for Success 
Dialogues”, have become a major platform wher e 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 pha rmaceuticals). 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 Asse ssment 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 Europe an Chemical Industry Council,191 
and CIAA, the Confederation of F ood and Drink Industries of the EU,192 have set up 
platforms for dialogue with stakeholders. 
European Technology Platforms (ETPs) often ha ve outreach activities and regularly consult 
with stakeholders. 
At national level, various stakeholder dialogue s took place (for example in Austria, France, 
Germany and the United Kingdom). These either fo cused on particular se ctors 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, representa tives of consumer organisations meet with 
regulators, academia and industry from both sides of the Atlantic , on a transatl antic 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 servi ces and US authorities for consideration and 
follow-up. 
The OECD Working Party on Nanotechnology (W PN) organised a “Conference on Outreach 
and Public Engagement in Nanotechnology”, in  Delft on 30 October 2008, as part of its 
                                                 
187 http://ec.europa.eu/health/ph_risk/ev_20071025_en.htm  
188 http://ec.europa.eu/health/ph_risk/ev_20081002_en.htm  
189 http://ec.europa.eu/health/ph_risk/ev_20091103_en.htm  
190 http://ec.europa.eu/health/ph_risk/documents/ev_20081113_lp_en.pdf  
191 http://www.cefic.be/en/582.html  
192 http://www.ciaa.be/e-newsletter/ns l2.asp?nsl_id=21&nsldet_id=134  
193 http://tacd.org/index.php?option=co m_docman&task=cat_view&gid=86  
194 http://tacd.org/index.php?option=co m_docman&task=cat_view&gid=75  
 
EN 74   EN related project. The overall objective was to  look at diverse experiences with public 
engagement and discuss best practice.195 The WPN is continuing to wo rk in this area, building 
on the findings so far, with delegate countries  undertaking public engage ment case studies in 
2009 and 2010. 
In addition, the OECD Working Partie s on Nanotechnology (WPN) and Manufactured 
Nanomaterials (WPMN) jointly organise d the “OECD Conference on Potential 
Environmental Benefits of Nanotechnology: Fost ering 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 th e environment and the economy. 
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 th e 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 act ors, scientific networks across areas of 
expertise, and specific traini ng. These should be carried ou t in cooperation with Member 
States, international organisa tions 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 nanomate rials 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 companie s have conducted a numbe r 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-f orms of metal oxides are produced in large 
quantities. 
In 2007 the OECD-WPMN identified fourteen nanom aterials, 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 (C
60) 
– Single-walled carbon nanotubes (SWCNTs) 
                                                 
195 http://www.oecd.org/document/2/0,3343,en_21571361_41212117_42324482_1_1_1_1,00.html  
 
EN 75   EN – Multi-walled carbon na notubes (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 la te 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 cosm etics: silicon dioxide, titanium dioxide and 
zinc oxide are used in the majority of cas es; 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 sa me substance as separate nanomaterials. Half 
of the nanomaterials were produced at labo ratory 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, aluminiu m hydroxide, magnesium oxide, calcium oxide, 
copper (II) oxide, palladium, platinum, coba lt, rhodium and a quantum dot. It is unknown 
whether these nanomaterials are on the European market. 
Also early in 2009, the European Commission se rvices compiled a preliminary overview of 
nanomaterials on the market, for the use of the CASG Nano. It conclude d that in addition to 
those listed above, more are bei ng 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 oxi de, germanium oxide, indium oxide, lanthanum 
oxide, molybdenum oxide, neodymium oxide, nick el, 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 unde r REACH as phase-in substances. 
On the basis of these evaluations it can be conc luded that a variety of nanomaterials are sold 
on the global market for research or industrial purposes. In cases where these are 
                                                
 
196 http://tacd.org/index2.php?option=com_docman&task=doc_view&gid=249  
197 http://www.epa.gov/oppt/nano/nmspfr.htm  
 
EN 76   EN 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-register ed 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 or der 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 ot her inorganic compounds, all possibly coated 
with layers of polymers, surfactan ts, or other inorganic materials. 
– Metal nanoparticles, most commonly s ilver, gold, aluminium and nickel.  
– Nanoporous materials (e.g. sili con dioxide, carbon, aluminiu m 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. ca rbon 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. nanostructur ed polymers and fibres). 
– Bionanomaterials (e.g. oligonucleotides, peptid es, proteins and bi oactive molecules). 
– Nanoencapsulations (e.g. liposomes, micelles,  solid lipids, polymersomes, emulsions). 
– Nanoclays (e.g. layered platelets of clays, ge nerally aluminosilicate ceramic materials). 
These materials are used in industrial sector s 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 coat ed 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, se lf-cleaning, non-stick or UV-re sistant coatings). Nanoporous 
materials are used for insulation (aerogels). 
Metal nanoparticles va ry 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 magn etic iron-based alloys are used for energy 
transmission, and light metals are used in stru ctural 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; a nd filtration solutions using ho llow nanofibres or antifouling 
coatings. 
                                                
 
198 Phase-in substances are, e.g., those previously listed in EINECS 
199 NanoRoadSME and ObservatoryNAN O projects; and Lux Research 
 
EN 77   EN Carbon nanotubes are used, for example, in polym er composites or foams with high electrical 
conductivity, in wiring, st rengthening of cement, nanostruc tured 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 packagi ng, 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 material s for batteries, fuel cells and supercapacitors; 
graphitic nanoherring in catalysts; and graphene in electronic appl ications, such as transparent 
conductive films, transistors and sensors. 
Quantum dots can be used for diagnostics, bio- labels and next-generat ion solar cells, while 
quantum dots and dendrimers boost LED output  and enable precision optical elements. 
Nanostructured materials, such as nanostructu red metallic alloys and nanoporous materials, 
are used for stronger and light er aircraft and automotive pa rts. They also enhance the 
performance of rechargeable batteries and catalytic convert ers. Diamond nanocrystals and 
nanostructured metal composites enable  more durable industrial parts. 
Metallic and semiconducting nanowires are used fo r smaller, faster microchips and memory 
devices, but also for displays, energy storage devices and sensors. Na nopolymers are used in 
transport and by packaging industries; and na nofibres for filtration of air or liquids. 
Engineered biomolecules (oligonu cleotides, peptides, proteins and bioactive molecules) are 
used for light-control materials and bio-based packaging materials. Liposomes, micelles, solid 
lipids, polymersomes, emulsions and silicon di oxide shells are used as encapsulators, for 
example to improve the solubility  and bioavailability of ingredie nts, to protect molecules from 
degradation, to shield undesirabl e 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 pr imarily as polymer additives, for example in 
heat-resistant thermoplastics and lightwei ght 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 severa l types of such products , and may be directly 
exposed to them in everyday life. 
The Woodrow Wilson database colle cts information on products that  are advertised  on-line in 
English and make nanotechnology claims. Such clai ms are often not substantiated, but rather 
used for unsupported publicity purposes. The Co mmission services have also made an 
assessment of the database and concluded that , of the 755 products co vered in January 2009, 
one third made “nano” claims without any spec ification of the nanomat erials used. Typical 
consumer products containing nanomaterials include cosmetics, sunscreens, cleaning 
products, anti-stain coatings, text iles, paints, and so on. The numb er of nanomaterials used is 
relatively small (silver, titanium dioxide, zi nc oxide, carbon, silicon dioxide, fullerenes, 
fullerols, carbon nanotubes, nanomicelles, na nospheres 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 registra tion 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. 
 
EN 78   EN 6.1.3.  Regulatory reporting 
REACH200 and CLP201 will provide knowledge about the safety of nanomaterials, their uses 
and volumes. Information from the implementati on of these Regulations is also the foundation 
for a number of other legislative areas. Irresp ective 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/EC
202 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, an d CLP on 20 January 2009. The registration 
deadlines are determined by the total tonnage
204 or toxicity of the s ubstance manufactured or 
imported. The first registration deadline is 30 November 2010 – for substances at 1,000 
tonnes per year or more. This deadline also ap plies to carcinogens, mutagens and reproductive 
toxicants (CMRs) with production of one tonne  or more per year; and persistent and 
bioaccumulative toxicants (PBTs) with produc tion 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 nanomater ials will gradually be come available after 
the first set of REACH registra tions of high-volume chemicals and the CLP notifications of 
all hazardous substances by the end of 2010. Th e former provides a safety dossier for each 
substance, including different forms and states, wh ile 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 regulati ons, ECHA will assess the information and make 
the data publicly available via its website.
205 
Information on what nanomaterials are on the mark et will also become increasingly available 
from pre-market intervention schemes under sector-specific regula tion. In particular, 
regulatory change has been made for cosmetic  products, meaning that nanomaterials which 
are not already subject to pre-market author isation (i.e. preservatives, colorants and UV 
filters) will be subject to a notification six mo nths before they are placed on the market. If 
necessary, the Commission will be able to as k the EU Scientific Committee for Consumer 
Safety (SCCS) for an assessment of the materials. 
                                                 
200 Registration, Evaluation, Authorisation and Restriction of Chemicals (EC Regulation 1907/2006) 
201 Classification, Labelling and Packaging of substances and mixtures (EC Regulation 1272/2008) 
202 O.J. L 123 24.4.1998, P. 1 
203 O.J. L 230 19.8.1991, P. 1 
204 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. 
205 http://echa.europa.eu/  
 
EN 79   EN Furthermore, the Regulation on Food Additives206 explicitly stated that a significant change in 
the production method or in particle size (e.g. prep aration 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. Howe ver, because of the cu rrent 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 re gards the use of nanomaterials 
in food. It is expected that the revision of this legislation will br ing 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, ther e 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 nanomat erials currently on the market will probably 
be registered together with the substan ces 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 polic y 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 nanomaterial s, including safe ty aspects in 2011. 
6.2. Regulation 
6.2.1.  Regulatory Review 
In June 2008, the European Co mmission adopted the Communicat ion “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 regulat ory research needs and related measures”.208 
According to the regulatory re view, existing EU legislation c overs in principle the potential 
health, safety and environmental risks in re lation to nanomaterials.  Certain aspects of 
production and products are at the same time s ubject to various Comm unity provisions. The 
protection of health, safety an d the environment needs to be  enhanced largely by improving 
implementation of current legislation. Neve rtheless, the Commissi on acknowledges that 
regulatory changes may be needed in light  of new information becoming available. 
The implementation of regulation is facilita ted by different types of documents, adopted 
within the regulatory frameworks, such as im plementing legislation, European standards, 
regulatory and technical guidance documents. These will need to be adapte d in order better to 
cover environmental and health risks in rela tion to nanomaterials. To do this, however, 
improved methods are needed for the characteris ation of nanomaterials ; the assessment of 
potential hazards, exposure and risks;  and risk management measures. 
                                                 
206 (EC Regulation 1333/2008) 
207 Regulatory Aspects of Nanomaterials , COM(2008)366; 
http://eur-lex.europa.eu/LexUriServ/LexU riServ.do?uri=COM:2008:0366:FIN:en:PDF  
208 SEC(2008)2036; 
http://eur-lex.europa.eu/LexUriServ/LexU riServ.do?uri=SEC:2008:2036:FIN:EN:PDF  
 
EN 80   EN The Commission and relevant EU Agencies are in the first place reviewing current documents 
that support implementation, such as implem enting legislation, standards and technical 
guidance, with regard to thei r applicability to, and appropr iateness for, nanomaterials. 
Commission working groups in charge of coordi nating the implementation of legislation are 
examining on an ongoing basis whether regulatory change on specific as pects 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 nanotechnolog y, legislation can be 
deemed adequate to cover the risks related to  nanomaterials. Given th e lack of appropriate 
data and assessment methods, the Parliament cons iders that regulatory change is necessary to 
address risks in relation to nanom aterials 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 prot ection. In evaluating the 
need to review EU legislation (REACH, wast e legislation, air and water legislation, and 
worker protection), the Commission will pay partic ular attention to the issues suggested by 
the Parliament, and report on its conclusions fr om 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, et hics, 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 syst em of governance at international level, to 
give clear, reliable and complete answers on th e 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 vari ous actions mentioned in this section, the 
Commission also intends to present in 2011 info rmation on types and uses of nanomaterials, 
including safety aspects. 
6.2.2.  Sectoral developments 
The European Parliament and the Council have ag reed on a recast of the Cosmetics Directive. 
In addition to the earlier pre-market authoris ation of UV filters, colorants and preservatives, 
the new regulation introduces various provisi ons specific to other nanomaterials. These 
provisions include a notificati on obligation for manufacturer s regarding the presence of 
nanomaterials in cosmetics not subject to prior authorisation; a possib ility for the Commission 
to request a safety assessment for such materials by the Scientific Committee for Consumer Safety (SCCS); and a labelling requirement fo r nanomaterial ingredients. The new regulation 
                                                
 
209 P6-TA-2009-0328, 
http://www.europarl.europa.eu/sides/getDoc.do?ty pe=TA&language=EN&reference=P6-TA-2009-0328  
210 2009/C 218/04, 
http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:C:2009:218:0021:0026:EN:PDF  
 
EN 81   EN introduces a definition of nanomaterials used in cosmetics ingredients. It also introduces an 
obligation on manufacturers to no tify 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 modificati on of the regulation on nov el food, the European 
Parliament has proposed various provisions specific to nanomateri als. In partic ular, it is 
proposed to make it exp licit that the use of nanotechnolog ies or nanomaterials for food and 
food ingredients already authoris ed will require a new authoris ation. However, discussions 
continue as part of  the second reading.  
The introduction of provisions specific to nano materials naturally requ ires 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 a nd scientific developmen ts in the field, the 
Commission is given a mandate to adjust thes e definitions in the light of technical and 
scientific progress, and to align them with de finitions subsequently ag reed 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 nanomateri als under REACH. On this  basis, the group will 
provide recommendations to the REACH Competent Authorit ies, advising the Commission. 
Stakeholders are invited to participate in the meetings. 
So far, three official meetings and an info rmal 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 Nanomateri als, 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 sp ecific aspects of nanomaterials. 
The Commission will propose a review on the Seveso  II Directive in 20 10, to align its Annex 
I to the UN Global Harmonisation System ( UNGHS). The Commission continues to follow 
carefully the issue of nanomaterials, also cons idering 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 w ill repeal and replace the current Directive 
98/8/EC concerning the placing of biocidal products on the market. 
                                                 
211 http://ec.europa.eu/enterprise/sectors/ch emicals/reach/nanomaterials/index_en.htm , 
http://ec.europa.eu/environment/chemicals/nanotech/index.htm  
212 COM(2009)267 of 12 June 2009 
 
EN 82   EN The European Food Safety Authority (EFSA) ha s evaluated an applic ation 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 au thorisation 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 su bmitted by the petitioner were 
insufficient to characterise adeq uately 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), c ontinues to support applicants during the 
development of nanomedicines. A number of scie ntific and regulatory as pects warrant further 
scientific research and debate (e.g. the impact of nanopharmaceutical components on biological systems, definition and borderlin e products, and impact on the evaluation of 
innovative nanomedicines). Nevertheless, the pharmaceuticals regulatory framework allows 
for a scientifically well-defined and robust ev aluation of benefit-risk  balance, on a case-by-
case basis, for each nanomedicine submitted to the Agency. 
An ad hoc  expert group on nanomedicines (includi ng academic specialists and regulatory 
scientists) was established recently to provide specialist input on new sc ientific and regulatory 
issues emerging in the development of novel na nopharmaceuticals, 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 internationa l activities in the sector and 
is now in the lead of an informal intern ational 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 identifyi ng 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 ch aracterisation of physicochemical 
properties. 
The Commission is aware that discussions are taking place at national level in some Member 
States, regarding legislative initiatives on nanoma terials. However, so far, no draft regulation 
regarding nanomaterials has been notified to the European Comm ission under Directive 
98/34/EC, which lays down a pro cedure for the provision of in formation in the field of 
technical standards and regulations.
214 
                                                 
213 Polyethylene terephthalate 
214 Official Journal L 204 , 21/07/1998 p. 0037 - 0048 
 
EN 83   EN 6.3. Safety concerns associated with the use of nanomaterials 
According to the opinions of the EU Scientific Committees,215 not all nanomaterials induce 
toxic effects. The Scientific Committees stre ss that the hypothesis that smaller necessarily 
means more toxic cannot be substantiated by th e published data. However,  certain health and 
environmental hazards have been identified for a variety of manuf actured 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 in stance. Experiments also indicate that carbon 
nanotubes with these characteristics coul d induce a specific fo rm of lung cancer, 
mesothelioma, which is also observed in re lation 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 ot her substances, in that some may be toxic and 
some may not, and some may be toxic only und er certain exposure cond itions. As there is not 
yet a generally applicable paradigm for th e identification of potential hazards of 
nanomaterials, the Scientific Committees cont inue to recommend a case-by-case approach for 
the risk assessment of nanomaterials. 
Scientific knowledge about hea lth, safety and environmental (H SE) aspects of nanomaterials 
is a critical factor for the implementation of safe ty 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 internationa l collaboration has been intensified. 
As with ordinary chemicals, the risk as sessment of nanomater ials depends on the 
identification of hazards and exposures. Howeve r, the science needed to test and measure 
hazards and exposures is more complex for nanom aterials than for ordinary chemicals. Their 
small size requires analytical tools with high resolution and precision. Their reactivity and 
tendency readily to undergo chan ges when in contact with su rrounding 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 hurdl e. 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 b een made in understanding the 
interaction mechanisms of nanomaterials with bi ological systems, and in the areas of analysis 
and measurement. However, there are still cons iderable uncertainties and knowledge gaps in 
assessing the short- and long-term risks of di fferent 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 wa s 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 Scien tific Committees advise on the potential risks 
of nanomaterials and respective methodologi es. Since 2005, the Commission has requested 
six opinions. The EU Scientific Committee on Emerging and Newly Identified Health Risks 
                                                 
215 on Emerging and Newly Identified Risks (SCENIHR), on Consumer Products (SCCP) and on food and 
feed in the European Food Safety Authority (EFSA) 
216 http://www.iom-world.org/r esearch/nanoparticles.php  
 
EN 84   EN (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 publishe d 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 Eu ropean projects, includ ing those described in 
section 1.3, and other research results, drawi ng 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 to xicokinetics 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 dr awing general conclusi ons 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 e nhancement and retardation);222 to potential hazards created by 
certain types of nanotubes;223 to the potential of some nanopar ticles 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 appropriat eness 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“: 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_012.pdf  
218 “Safety of nanomaterials in cosmetic products”: 
http://ec.europa.eu/health/ph_risk/c ommittees/04_sccp/docs/sccp_o_123.pdf  
219 The Potential Risks Arising from Nanoscience an d Nanotechnologies on Food and Feed Safety: 
http://www.efsa.europa.eu/cs/B lobServer/Scientific_Opinion/sc_op_ej958_nano_en,0.pdf  
220 http://www.emea.europa.eu/pdfs/human/genetherapy/7976906en.pdf  
221 That is, the determination of properties 
222 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 
223 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 
224 See, e.g., 
http://www.efsa.europa.eu/cs/BlobS erver/Scientific_Opinion/sc_op_e j958_nano_en,0.pdf?ssbinary=true  
225  
-Holbrook RD, Murphy KE, Morrow JB, Cole KD, Tr ophic transfer of nanopa rticles 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 
 
EN 85   EN 6.4.1.  Characterisation, metrology and reference materials 
A number of available measurem ent and analytical methods are generally applicable at the 
nanoscale. However, these need to undergo form al validation and harmonisation, especially at 
low-nanometre resolutions. The ar ea is research-intensive becau se of the many ambiguities in 
the work with nanomaterials. In this respect, and especially for specifi c 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 im plementation of regulations. 
If specific requirements regarding nanoparticle  characterisation are to be imposed by 
regulation, this will entail an op erational quality assurance system for laboratories. In this 
context, the activities of EU  producers of reference mate rials are highly relevant. An 
increasing number of reference materials are be coming available, includ ing those produced by 
the Commission’s JRC.
226 However, most of these referen ce 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 Eur opean Standards Bodies (CEN/CENELEC/ETSI), 
inviting them to present a programme of standa rdisation needed to su pport the introduction to 
the market of nanomaterials and nanotechnologi es (details are given in sub-section 4.4.4). 
CEN presented a programme in May 2008, provid ing 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 ch aracterisation of the 
nanomaterial in question immediately preceding te sting, 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 bei ng introduced into the test systems. This is to 
ensure that the test results are actually linked to  the nanomaterial in ques tion, 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 genera l, the OECD guidelines are applicable to 
investigating the health effects of nanomateria ls with the important proviso that additional 
consideration needs to be given to the physicoche mical characteristics of  the material tested, 
including dosing. In some cases, there may be a need for further modi fication to the OECD 
guidelines. Preparation of samp les and dose administration are cr itical 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 http://www.irmm.jrc.ec.europa.eu/  
227  
http://www.oecd.org/department/0,3355,en_2649_37015404_1_1_1_1_1,00.html   
 
EN 86   EN tests and therefore guidance has been developed on sample prep aration and dosimetry for the 
safety testing of nanomaterials. The review menti oned here is consequently  seen as a “living” 
document, highlighting the feasibility of va rious approaches and allowing for continuous 
updates, given the rapid developments in th is 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 inha lation route for exposure to nanomaterials, and 
the anticipated difficulties in assessing the effect s of nanomaterials by th is route, a document 
on “ Non-inhalation exposure methods for st udies on the pulmonary toxicology of 
nanoparticles ” was produced for use within the OE CD sponsorship programme. This also 
included results of in vivo  tests from the EU-funded Nanosafe2 project. This document 
compares currently available exposure techni ques for the inhalation route, including the 
advantages and limitations of inhalation tests a nd intra-tracheal instillation tests, from the 
viewpoint of pulmonary toxicology. 
Current research on nanomaterial toxicity a nd associated mechanisms relies heavily on non-
validated alternative testing methods that are no t always used with standardised procedures. 
This leads to considerable uncertainties in th e research results and their comparability. To 
address this problem, some research projects ha ve developed standard operation procedures to 
ensure wider comparability of the result s and the ongoing work in the OECD-WPMN 
supports these activities. 
Some of the test guidelines for degradation a nd accumulation are not applicable to the testing 
of nanomaterials, while others are applicable with limitations or under specific test conditions. 
General guidance documents should therefor e be developed for testing the fate and 
degradation of nanomaterials. It is also importa nt to perform a detailed  review of the OECD 
bioaccumulation methods. 
6.4.3.  Potential exposure thro ughout the life cycle 
The various projects on occupational, human health and environmental exposure have made 
substantial contributions to guidelines on e xposure 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 measur es exist (e.g. ISO, 
BSI, ASTM), as well as guidance documents fo r measurement of exposure (parameters) or 
monitoring. For the time being, these docum ents recommend the implementation of a 
precautionary approach in the manufacture an d use of nanomaterials, without being too 
restrictive. 
– However, more specific data on the effectiven ess of a larger variet y of exposure control 
measures are needed, and therefore further work is in progress. Data should be 
forthcoming in the near future from the many pr ojects 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 can not currently be evalua ted 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   
 
EN 87   EN – 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 acknowledg ed by experts, or mixtures of  control measures considered 
to be practically achievable for theo retically 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, th e next step would be  to collect data 
with respect to exposure. The data s hould be collected using harmonised and 
appropriate sampling strategies and equi pment, 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 storag e 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 quantitat ive 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 ecotoxic ity, environmental fate and behaviour 
Many of the general factors described in the c ontext of toxicity (sub-section 6.4.2 above) also 
apply to ecotoxicity. 
Research work has so far focused more on hu man toxicity than ecotoxicity. Practically no 
work has been done on the issue of secondary toxicity. Methodological difficulties exist with 
regard to testing, because commercial nanomater ials often present significant differentiation 
with regard to their labelled properties, leading to unrel iable and irreproducible results. 
Moreover, the energy dependent uptake and th e intracellular presence of nanoparticles pose 
the question of bioaccumulation, which is becoming increasingly important. 
Regarding the verification of available test gui delines for ecotoxicity, it was concluded that 
the guidance on preparation, delivery, measuremen t, and metrology is currently inadequate 
for the testing of nanomaterials, although the ba sic ecotoxicological prin ciples are applicable. 
On the other hand, the terminology used in the OECD  test guidelines is not descriptive of, or 
specific to, the particulate or fi brous 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 possibl e exposure routes precludes making specific 
recommendations as to the develo pment 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 wate r is still limite d, especially 
with regard to humic acids, a nd therefore the currently obtained PNEC values (predicted no-
effect concentrations) are to be considered preliminary. A crucial st ep in making standard 
ecotoxicity test methods more reliable for nanom aterials is the collec tion of knowledge on the 
specific direct and indirect e ffects of nanomaterials. Hypothesi s testing and the assessment of 
non-standard endpoints may play an important role in this proce ss. In order to make progress 
 
EN 88   EN in closing knowledge gaps, there is the need to  analyse different endpoints and consider the 
appearance of measurement arte facts and indirect effects. 
Work on the fate of nanomaterials in the envi ronment and behavioural aspects has only just 
started and results from projects should be avai lable in the next two years or so. An exception 
concerns some simulation results related to th e aqueous environment, which confirmed that 
the basic laws of colloidal science also apply to  the stability of nanomaterials in suspensions 
and showed that natural organi c matter stabilises nanomaterial suspensions in fresh water. 
These results also contributed to the gui dance 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 em issions, resources consumed, as well as 
environmental and health impacts, which are associated with produ cts and services. LCA 
takes into account the product’s full life cycle, from the extr action of resources, production, 
consumption and recycling, up to the disposal of waste. 
The LCA process should also include economic, social and geographic as pects, 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 guidanc e, 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 regulato ry aspects of nanomaterials of 2008 and it s accompanying 
Staff Working Document (see section 6.2 above), a thorough analysis of  research needs was 
made from the regulatory perspective. Si nce then, the SCENIHR and the Scientific 
Committee of EFSA have provided their opini ons on potential environm ental, health and 
safety aspects of nanomaterials, and on what fu rther 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 c ontributed substantially to the knowledge base on the potential risks 
of nanomaterials to the environment, human hea lth and safety. This is especially the case in 
the fields of nanomaterial characterisati on, exposure measurement including sampling 
strategies and mitigation, and hazard identification. 
However, a number of fundament al 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 th e safety of nanomaterials be updated on a 
sound scientific basis. Without  validated and standardised methodologies, including proper 
                                                
 
229
 http://www.nanoforum.org/nf06~modul~showmore ~folder~99999~scid~483~.html?action=lon
gview_publication&  
230
 ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/lca_nanotechnology_workshopoct2006_pr
oceedings_en.pdf  
 
EN 89   EN instrumentation, it is clearly impossible to ensu re 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 cu rrent studies, the following work is needed in 
specific areas of risk assessment, in the shor t-term (up to 4 years), the medium-term (5-8 
years) and the long-term (9-11 years). These pr iorities 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 met hodologies (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 rele vant properties (size, shape, surface area 
and surface chemistry); particle size dist ribution; and physicochemical and biological 
parameters of nanomaterials in various matri ces, biological and environmental media, and 
under various conditions. Also re levant are the defi nition of the metrics most appropriate 
for hazard characterisation and exposure asse ssment, and the development of reference 
nanomaterials. It should finally be noted th at several characteri sation 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. Th is notes the progress in making reference 
materials available (including certified referen ce materials), to underpin the development, 
validation and quality assura nce of such methodologies. 
– To address fundamental phenomena and biological  interactions. Such re sults should inform 
the work on toxicity and ecotoxicity, as well as the development of reference materials (and studies into their homogeneity and stabi lity). This notes the progress in the “basic” 
characterisation of nanomateria ls in biological and environm ent media (with regard to 
particle size, surface characteri stics, substances on particle  surface, particle charging, 
agglomeration, de-agglomeration, kineti cs, solubility, formulation, explosion 
characteristics etc). 
Medium- to long-term needs: 
– To develop more reference materials and certifi ed reference materials, covering especially 
differences in shape and structure, surface area, charge and surface chemistry. Suitable 
reference materials must be prov ided to relevant projects. Re producibility is a crucial issue 
and covers: (i) preparation (esp ecially batch-to-batch variati ons); (ii) dispersions (e.g. 
without additives); and (iii) the stability of biological material s. In addition it is important 
to ensure that the reference material is rele vant to the situation be ing tested and to the 
material in commerce. In achieving this, a harmonised methodology should also be put in 
place, to ensure the comparability and subseque nt acceptance of test results, as well as the 
reference materials themselves. 
– To develop and certify test aerosols for toxici ty studies. The relevant requirements for 
these, in addition to the primary nanomaterial s characterisation, are: (i) to describe nano-
aerosol characteristics immediat ely after release using aeros ol dynamic parameters and 
models; (ii) to assess characte ristics of “aged” nano-aerosols in the typical size range for 
auto-agglomeration (20-200 nm), and the typi cal range for attachment to background 
 
EN 90   EN aerosol (less than 1 micrometre); and (iii) to study the toxicity of aged nanoaerosols 
(homogeneous and heterogeneous agglom erates, 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 ar e suitable for detecting adverse effects of 
nanomaterials to human health, incl uding acute and chronic toxicity.  
Short-term needs: 
– To integrate the information already availa ble into existing guidance documents and boost 
their application through aw areness 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. Th is is required for 
existing as well as for new te st methods and strategies. 
– To investigate in greater detail the toxi cokinetics, metabolism and excretion of 
nanomaterials, and their potential to  cause adverse health effects. 
– To develop an approach, including the cal culation 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 s hort- and long-term 
toxicological impacts and indi vidual or combined physicochemical parameters, such as 
mass, surface area, number concentr ation and size, allowing also  for the link to historical 
data. To ensure that information on both the ap proach and the toxicity data is effectively 
transferred to the expert communitie s on human and workplace exposure. 
– To perform additional studies on the poten tial hazards of nanof ibres and nanotubes, 
building on the recently published ones. This wo rk 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 endpoint s, assessing and quantifying the fate of 
nanomaterials in the body, orga ns, tissues and cells. Additi onally, possible intermediate 
deposition should be quantified. 
– To study the acute and chronic impacts, in cluding 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 us ed alongside the generation of in vitro data both 
to create the model and to test it. 
 
EN 91   EN 6.5.3.  Test methods for environmental effects 
In this area also, one can bu ild 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, af ter ensuring a proper sample administration, for 
detecting adverse effects from na nomaterials to the environment, especially related to their 
ecotoxicity, bioaccumulation, pers istence and bioavailability. 
Short-term needs: 
– To integrate the information already availa ble in existing guidance documents and boost 
their application through aw areness raising activities. 
– To develop further, compare and validate in vitro , in vivo  and in silico  test methods, and 
testing strategies, covering also degradati on and accumulation, in order to speed up the 
adjustment of current test guide lines 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 m acromolecules 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 a nd individual combined to physicochemical 
factors such as mass, surface area, number c oncentration and size, allowing also for a link 
to historical data. To ensure that informati on 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 pot ential bioconcentration, bioaccumulation or 
persistence in the environment.  
6.5.4.  Exposure information th roughout the life cycle 
Short-term needs: 
– To validate and harmonise available methodol ogies related to sp herical 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 acceptan ce criteria for reliable tests incl uding 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 na nomaterials, including aerosols, for exposure 
assessment and for scenarios of primary re lease of nanomaterials in workplace air. 
– To finalise the harmonisation of availa ble simulation methodol ogies (including 
performance criteria for the accep tance of test results); and ultimately to fine-tune these for 
different applications, materials, uses and environmental species. This priority builds on 
 
EN 92   EN the first generation of simulation methodologies, addressing coating stab ility 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 assessm ent. 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 app licable to existing or curren tly developed preparation and 
manufacturing techniques, and assess the eff ectiveness of personal protection equipment. 
This work should also include the developmen t of harmonised and validated analytical 
methods to detect and measure ambient concen trations of free nanomaterials in various 
matrices. 
– To satisfy the requirements in  the previous inde nt, 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 out puts from the needs summarised above, it is 
essential to (i) develop and va lidate model aerosol sources fo r relevant classes of release 
mechanisms and species for use in toxicological studies; (ii) develop di fferent test aerosols 
for toxicological studies; and (iii) develop ne w or refine existing aerosol dynamic models 
for predicting nanomaterial evolution includ ing their validation, sensitivity testing. 
– To fine-tune existing simulation methodologies in relation to product stability related to 
worker exposure and skin penetr ation for other types or varie ties of nanomaterials used in 
different applications and mode lling 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 s hould allow an investigation of synergistic 
effects of mixed exposures and exposures fr om 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 cu rrently available guidelines for the life cycle 
assessment of nanomaterials and nanotec hnology-based products, building upon results 
from completed and ongoing activities. To de velop 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 preparat ion and manufacturing, by al so boosting thei r application 
through awareness raising activities and uptake fo r future activities. 
– To further refine existing mitigation a pproaches, by building on existing and newly 
developed exposure models including av ailable and newly generated data. 
 
EN 93   EN – 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 a nd 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 categoris ation of nanomaterials based on their 
environmental fate and behaviour. 
– To generate information to develop an appr oach, including the calc ulation of mass from 
number concentration, surface area and size,  allowing for a link to historical data. 
– To finalise the harmonisation of availa ble simulation methodol ogies (including 
performance criteria for the accep tance 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, bio accumulation and fate, and the distribution of 
nanomaterials in aqueous environments. 
– To perform a revision of the standard OECD me thods for measuring sol ubility 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 extrap olation approaches that can address various scenarios 
with appropriate sensitiv ity 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 nanomateri als from environmental species into the food 
chain. This should include diet ary studies and an assessment of the role, if any, of the 
interaction of nanomaterials with the availabl e amount of feed for various animal species 
in different environmental compartments and other environmental contaminants. This is 
noting initial results pointing towa rds 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, si nce such fragments ma y have a substantial 
influence on the uptake and translocation of such functionalised nanomaterials within the 
body of different animals in vari ous 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 sti ll in the embryonic research 
phase. Although such nanomaterials are still in the research phase, this  will facilitate the 
progress from “reactive” research on environmen tal, health and safety issues towards 
“anticipatory” research. Moreover,  it is demonstrating the imple mentation of the “integrated, 
 
EN 94   EN safe and responsible” principle for the de velopment of nanotechnologies by equally 
contributing to their future societal acceptance. 
6.5.8.  Networking and Infrastructure 
Progress has already been made in the netw orking 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 infrastructure s 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 ac tive on medical applicatio ns of nanomaterials 
with the networks active on environmental, health and safety research. This will also 
facilitate the progress from “reac tive” 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 sec tion 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 toxi city. However, their acceptance in the ECVAM 
validation process and their development into  high-throughput testin g processes requires 
further research, as well as the developmen t 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 innova tive environmental, safety and health 
research on the one hand, and the collection of reference data and routine testing by 
industry and competent author ities on the other hand. Clearly, Research Framework 
Programme resources have to be used for br eakthrough innovation – pr oposals that are not 
sufficiently innovative do not score high enough in the eval uation to be funded, no matter 
how important they may be. 
– As the proper application of risk assessmen t and Life cycle Assessment (LCA) requires 
reliable and generally agreed databases, a m echanism should be established to use existing 
or establish new ones and ade quately populate those. This need cannot be covered by 
bibliographic databases. The i ssues are how such data can be anonymised, aggregated and 
made publicly available; and how such a mech anism could benefit from proprietary data. 
Various approaches for anonymising and aggr egating data are available and should be 
employed to the maximum possible extent.  
– Particular focus should be gi ven to the activitie s of OECD-WPMN and ISO, to further 
develop and validate test methods and stan dards. Regulation requires internationally 
harmonised and validated standards and me thodologies. The active contribution of the 
Commission to this work is therefore essential. This work has been instrumental and should continue. 
 
EN 95   EN – Cooperation with Member States and internat ional partners should continue, as it is 
essential in prioritising research needs, boos ting synergies and using resources efficiently. 
– Greater transparency about research and rese arch results is needed. Research projects 
funded by public money should gene rate publicly available data. 
– In accordance with the “integrated, safe and re sponsible” principle for the development of 
nanotechnologies, and the Co mmission’s Code of Conduct,  EU-funded research should 
integrate safety aspects at the earliest possibl e stage in the development of applications and 
new “active” nanomaterials. This will facilitate  the progress from “reactive” research on 
environmental, health and safety issu es 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 methodol ogies. 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 nomencl ature is ongoing and the first terminology 
definitions have been released.232 The European Commission a nd EU Member States put 
significant resources into these activities. 
Collaboration with internationa l partners within EU-funded re search projects is actively 
supported and several projects have partners outside the EU. Coordi nated calls are also 
organised with other countries, like the US. Th is collaboration extends  to research on risk 
assessment.  
6.6.1.  OECD Working Party on Manufac tured 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 Wo rking Party on Manufactured Nanomaterials 
(WPMN), to promote international cooperation in the health, safety and environmental issues 
of manufactured nanomaterials. This is the ma in forum for internatio nal cooperation in this 
area, for example in the developm ent of test methods needed for the proper implementation of 
regulation. 
The Working Party is implementing its work thro ugh eight specific projects  to further develop 
appropriate methods and strategies: 
1. Development of a Database on Human Hea lth 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 Sche mes and Regulatory Programmes; 
6. Co-operation on Risk Assessment; 7. The role of Alternative Methods in Nanotoxicology; and 8. Exposure Measurement a nd Exposure Mitigation. 
                                                
 
232 CEN ISO/TS 27687:2008 
 
EN 96   EN 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 test s comparable, given the involvement of many 
independent research institutions. For nanomaterials this is a significant challenge, as reference nanomaterials, measurement and dosim etry are still under continuous development. 
The OECD has acknowledged these shortfal ls and developed a “Guidance manual for 
sponsors”;
235 and guidance for sample preparation a nd dosimetry, which is being finalised. 
There is a close collaboration with the sta ndardisation work of ISO. The programme will 
serve the following purposes: 
– It will generate data about th e 14 nanomaterials on 59 endpoints. 
– It will assess the applicabili ty 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 alte rnatives to animal testing methods. 
Testing strategies used in the Sponsorsh ip 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. Speci fic attention should also be paid to tests 
which provide mechanistic information and information on metabolic pathways. 
A specific focus is also given in the spons orship programme to the development of non-
animal and alternative methods. A specific st eering group is focusing on alternative test 
methods and test strategies and their valida tion. A report presented to the WPMN in 2008 
addressed the role of alternative methods, prio ritisation schemes for te st method selection, 
quality and good laboratory practice,  validation and testing strategi es. At this stage, however, 
it is not possible to make recommendations as to specific alternative approa ches to be used for 
testing nanomaterials. It is not clear how information genera ted 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, th e Steering Group on exposure assessment and 
mitigation (SG8) started its work recently, a nd five documents have been published so far:
236 
– “Report of an OECD Workshop on Exposur e 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  
236 All of these reports can be downloaded from the following websites: 
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  
 
EN 97   EN – “Identification, Compilation and Analysis of Guidance Information for Exposure 
Measurement and Exposure Mitigati on: Manufactured Nanomaterials” 
– “Emission Assessment for Identification of Sour ces and Release of Ai rborne Manufactured 
Nanomaterials in the Workplace: Compilation of Existing Guidance” 
– “Comparison of Guidance on Selection of Skin  Protective Equipment and Respirators for 
Nanotechnology Workplace: Manufact ured Nanomaterials”; and 
– “Preliminary Analysis of Exposure Measurem ent and Exposure Mitigation in Occupational 
Settings: Manufactured Nanomaterials”. 
Currently, SG8 works on a compilation of labo ratory guidance, and started discussions on 
activities related to environm ental 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 work shop of the Steering Group on Risk Assessment 
(SG6), including case studies on nano-silver, titanium dioxi de and carbon nanotubes. The 
OECD-WPMN also assessed the situation in th e 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 Te chnical Committees in ISO (TC 229) and in 
CEN (TC 352) were presented in sub-secti on 4.4.3. Of the forty documents developed by 
ISO/TC 229, the two that have alre ady 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 definitio ns for the area of nanomaterials. The second 
published document is an informative technical  report on health and safety practices in 
occupational settings releva nt to nanotechnologies.239 Among the other documents being 
developed in ISO/TC 229, about ten are rela ted to the terminologies of different 
nanotechnology domains.240 The Commission (mainly the Join t Research Centre) is closely 
following the work in ISO and CEN. 
In addition, ISO/TC 146 released  a technical report on inhala tion exposure characterisation 
and assessment of ultra fine and nanostru ctured aerosols in workplace atmospheres.241 And in 
the particle characterisation group  in ISO/TC 24/SC 4, the partic ular issue of nanoparticle size 
measurements and the required reference materials is considered.242 
In the international metrology and pre-normativ e arenas, collaborative  organisations have 
been set up between EU partne rs and non-EU countries, as de scribed 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 in to the ISO standardisation process. 
                                                 
237 http://www.oecd.org/document/26/0,3343,en_2649_37015404_42464730_1_1_1_1,00.html   
238 CEN ISO/TS 27687:2008 
239 ISO/TR 12885:2008 
240
 http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_co
mmittees/iso_technical_committee.htm?commid=381983  
241 ISO/TR 27628:2007 
242 http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=47166  
 
EN 98   EN 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, harmonisa tion and uptake of documentary standards 
broadly relevant to the field of measurem ent and characterisation for nanotechnologies; 
– identify good practice and guidance documents covering the suitability  and limitations of 
measurement and characterisation tec hniques for use with nanomaterials; 
– ensure a greater dissemination, verification a nd validation of handling and testing protocols 
and related procedures by the broader community; and 
– ensure that, in the area of na nomaterials characterisation, ther e 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 intern ational 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 basi s 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 particul ar there is a regulatory dialogue  with countries such as the 
US, Canada, Australia and Japan. Several mee tings 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 (ICCR
244), 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 seri es 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 nanomateria ls. Discussions on nanomaterials have been 
initiated in one of the expert committees. Th e group has however deci ded to await results 
from the OECD-WPMN before carrying out further work. 
The Strategic Approach to International Chem icals Management (SAICM) is a broad policy 
framework for chemicals management progra mmes 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 International Cooperation on Cosmetics Regulation 
245 International Conference on Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use 
246 Global Harmonisation Task For ce (for medical device regulation) 
247
 http://www2.lse.ac.uk/internationa lRelations/centresandunits/regulatingnanotechnologies/nano
home.aspx  
 
EN 99   EN second conference in May 2009, SAICM iden tified nanotechnology and manufactured 
nanomaterials as an emerging policy issue. Alth ough 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 governme nts, 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 devel oping countries and countries with economies in 
transition. For example, REACH,  in its Articles 118-120, provide s detailed help and guidance 
on the exchange of data and information on HSE aspects. 
7. INTERNATIONAL
 COOPERATION 
A proper and efficient approach to nanotec hnology and nanomaterials must take into 
consideration the internationa l dimension, in terms of R&D, access to information and 
regulation. International coopera tion, including collabo ration in research but not limited to 
this, is now an integral part of the Commi ssion’s policy in all areas of the Action Plan. 
Throughout this staff working document, referen ce has therefore been made to work at the 
international level, and the following is  meant as a summary of headings only: 
– Collaboration in research (s ection 1.6), including research  on HSE issues (section 1.3) 
– The Third International Dialogue in 2008 on the responsible development of 
nanotechnology (sub-section 1.6.3) 
– Cooperation on regulatory aspects, mainly but not exclusively through the OECD-WPMN 
(sub-section 6.6.1) 
– Contribution to international standards, th rough 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) 
 
EN 100   EN Annex 1: Degree of fulfilment of Commissio n Actions in Nanotechnology Action Plan 
2005-2009 
The following table gives an assessment, necessari ly subjective, of the degree of fulfilment of 
each one of the goals identified for Commi ssion action in the Na notechnology Action Plan 
2005-2009 (the original text for each  goal is reproduced). The rati ngs 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 A ND 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; 3 
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 Pl atform 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 complement ary research in other thematic areas; 3 
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, in cluding portable in situ measuring 
devices10; 2 
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). 3 
2. INFRASTRUCTURE AND EURO PEAN 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 cooper ation with and technology transfer from 
academic R&D teams to conceive advan ced prototypes and validate them in 
industrially relevant environments; 2 
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. 2 
3. INTERDISCIPLINARY HUMAN RESOURCES: EUROPE NEEDS 
CREATIVITY   
a) Promote networking and disseminate best practices for education and training 2 
 
EN 101   EN in N&N. A dedicated workshop is taking place in 2005 and th e proceedings will 
be widely disseminated; 
b) Explore how to best encourage the development of relevant supporting 
activities (e.g. cross-border thematic netw orks 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 ‘interdisc iplinary European award in N&N’ that 
recognises scientific advances and entrep reneurship and/or progress in the area of 
safety and the environment, in line with the integrated and responsible approach. 
Sponsorship from industry and other inte rested organisations will be sought; 
d) Explore the possibility for dedicated N&N ‘Marie Curie’ actions (e.g. 
fellowships) that stimulate transnationa l 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. Specific action deemed 
unnecessary, since nanosciences and 
nanotechnologies are taking 
an adequate share of generic activities 
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 a rrangements between industry and R&D 
organisations / universities e.g. the ‘Berliner Vertrag’ or the Responsible 
Partnering Initiative; 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; 3248 
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; 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 Offi ce (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 Work of ICPC NanoNet and ObservatoryNANO projects 
249 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 102   EN 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 ethi cal 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; 3 
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; 3 
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 Commi ssion at the request of the European 
Parliament to assess and conduct a cost -benefit analysis of biotechnology and 
genetic engineering; 2 
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 assess ment of the effectiveness of different 
approaches across Europe as well as pr oviding ‘early warning’ of particular 
concerns; 2 
e) Produce multilingual information materi al 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; 3 
6. PUBLIC HEALTH, SAFETY, ENVIRONMENTAL AND CONSUMER 
PROTECTION  
a) Identify and address safety concerns a ssociated 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; 2 
b) Promote safe and cost-effective measur es 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 e xposure, (ii) evaluate the adequacy of 
current approaches to control exposure and (iii) launch appropriate initiatives, 
propose measures and/or issue recomm endations; 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 
Engineering “ Nanoscience and nanotechnologies: opportunities and 
uncertainties ” 1 
c) Develop with Member States, interna tional organisations, European agencies, 
industry and other stakeholders, terminology, guidelines, models and standards for risk assessment throughout the wh ole 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; 2 
d) Examine and, where appropriate, propose adaptations of EU regulations in relevant sectors in light of the above paying particular, but not exclusive, 2 
 
EN 103   EN 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 le vel 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 es tablishment of a 
dedicated database to share toxicologi cal and ecotoxicological as well as 
epidemiological data; 2-3 
c) Support the creation of a free and op en European electronic archive of N&N 
scientific and technical publications acco rding to the principles set out in the 
OECD Declaration on Access to Research Data from Public Funding. 3 
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 policie s, health and consumer protection), 
related initiatives throughout the Union and other relevant activities (e.g. the 
Commission’s Biotechnology Steering Co mmittee), so to ensure maximum 
effectiveness; 3 
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; 3 
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. 2250 
 
                                                 
250 Some activities have been carried out, including sectoral innovation foresight. HSE activities led to a 
substantial concentration of nanotechnology applicatio ns mainly in health, elect ronics & energy fields. 
However, a real enhancement of exploitatio n and application has not been achieved. 
 
EN 104   EN 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) indust rial 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 an d pharmaceutical; OG: oil and gas. 
LuxResearch, 2009 and 2008; NanoRoadSME, 2008; and ObservatoryNANO, 2009 
Nanomaterial Description Examples of a pplications 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 
 Ae: Metal and composite coatings with ceramic nanoparticles for 
aerodynamic surface (I ). Au: Cerium oxide NPs for fuel 
additives to increase fuel efficien cy (I). Au: NP-c oated interior 
parts to stand extreme heat and pr essure (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 co atings 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).  
Metal nanoparticles  Metal nanoparticles are 
most commonly silver, 
gold, aluminium or nickel 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 embedde d in polymers as antimicrobials 
(S). Co: Nanostructured alloys render steel much stronger, 
together with carbon nanotube s (CNT) (S). Mnf: Silver NPs 
embedded in supports and polymers as antimicrobial (S). Mnf: 
Specially engineered NPs impr ove 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 antimicrobial s and drug carriers (S). 
Nanoporous 
materials 
 Materials (e.g. silicon 
dioxide, carbon, 
aluminium oxide, various 
polymers, metals and 
silicon) with pores of 0-100 nm  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). 
 
Carbon nanotubes 
 Single-walled nanotubes 
(SWNTs), generally about 
1 nm in diameter 
Multi-walled nanotubes 
(MWNTs), diameter 5-100 CNT/polymer composites and foams with high electrical 
conductivity for applications in conventional cold cathode or 
polymer LEDs. 
Ae: CNTs for Cu replacement in wi ring (I). Au: CN Ts 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: 
 
EN 105   EN 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. C
3N4 , Si 3N4 
covalent carbides like SiC and B
4C and metallic 
carbides like TiC or LaC 2  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 
 Nanosized crystals of 
semiconductor materials Quantum dots can be used for diagnostics, bio-labels and next-
generation solar cells. 
Dendrimers  Dendrimers, 2 nm to 20 
nm diameter El: Nanoscale engineering and NPs like QDs and dendrimers 
boost LED output and enable pr ecision optical elements (I). 
Nanostructured 
materials Nanometre-sized metal 
grains or layers of various materials 
 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 electr odes 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 
 Metallic and 
semiconducting wires, <100 nm in diameter and 
many microns in length 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: Nano structured electrodes and NP 
electrode coatings for better consumer devices (I). El: Soldering and bonding at lower temperatures protects nearby components 
(I). 
Nanopolymers  Nanostructured polymers 
and fibres (10 nm diameter) Nanopolymers for applications in the transport and packaging 
industries. Nanofibers for f iltration of air and liquids.  
Bionanomaterials Engineered biomolecules 
(oligonucleotides, 
peptides, proteins, and 
bioactive molecules) with 
size 0-1,000 nm Co: Light-control materials (I). EE: New processes enable bio-
based packaging materials to be made from waste or 
strengthened for longer usage (I). 
 
Nanoencapsulation  Liposomes, micelles, solid 
lipids, polymersomes, 
emulsions, and silicon 
dioxide shells as encapsulators 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 
 
EN 106   EN 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 clad dings, metal nanocomposites for 
stronger cables (I). 
 
EN 107   EN Annex 3: List of Acronyms 
CASG Nano REACH Competent Authoritie s Sub-group on Nanomaterials 
CEFIC Conseil Européen de l’Industrie Chimique 
CEN European Committee for Standardisation 
CENELEC European Committee for Electrotechnical Standardisation 
CIP Competitiveness and Innovation Programme 
CLP (Regulation on) Classification, Labelli ng and Packaging (of substances and 
mixtures) 
EC European Commission 
ECHA European Chemicals Agency 
ECVAM European Centre for the Valid ation of Alternative Methods 
EESC European Economic and Social Committee 
EFSA European Food Safety Authority 
EGE European Group on Ethics in Science and New Technologies 
EIT European Institute of Innovation and Technology 
ELS(A) Ethical, Legal and Societal (Aspects) 
EMEA European Medicines Agency 
ENIAC European Nanoelectronics Initiative Advisory Council 
EPA US Environmental Protection Agency 
EPAA European Partnership on Alternativ e Approaches to Animal Testing 
EPO European Patent Office 
ERA European Research Area 
ERC European Research Council 
ESFRI European Strategy Forum on Research Infrastructures 
ETP European Technology Platform 
ETSI European Telecommunication Standards Institute 
EU-OSHA European Agency for Safety and Health at Work  
 
EN 108   EN FPN Nth Framework Programme of the European Community for research, 
technological development a nd demonstration activities 
HSE Health, Safety and Environmental (issue s) – also referred to as EHS (issues) 
ICPC International Cooperatio n Partner Countries 
ICT Information and Communicat ion Technologies (in FP7) 
IEC International Electrotechnical Commission 
IPR Intellectual Property Rights 
ISO International Organizatio n for Standardization 
IST Information Society Technologies (in FP6) 
IUPAC International Union of Pure and Applied Chemistry 
JRC (European Commission) Joint Research Centre 
JTI Joint Technology Initiative 
JU Joint Undertaking (e.g. ENIAC JU) 
KBBE Knowledge-Based Bio-Economy (in FP7) 
KIC Knowledge and Innovation Networks (of EIT) 
NEST 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 nanometre, 10-9 metres  
NMP Nanosciences, Nanotechnologies, Materials and New Production 
Technologies (in FP6 and FP7) 
NoE Network of Excellence 
NSF 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 Infras tructure for Nanostructures 
R&D Research and Technological Development 
 
EN 109   EN REACH (Regulation on) Registration, Evaluati on, Authorisation and Restriction of 
Chemicals 
SCCP Scientific Committee on Consumer Products (up to March 2009) 
SCCS Scientific Committee for Consum er Safety (from March 2009) 
SCENIHR Scientific Committee on Emerging a nd Newly Identified Health Risks 
SICA Specific International Cooperation Action 
SME Small and Medium Enterprise 
SRA Strategic Research Agenda (of ETP) 
S&T 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 Ma nufactured Nanomaterials