Communication from the Commission to the Council, the European Parliament and the European Economic and Social Committee - Nanosciences and Nanotechnologies: an action plan for Europe 2005-2009. First Implementation Report 2005-2007
Date: 2007-09-06
Institutions: European Commission
Subjects: action programme, nanotechnology, new technology, report, research and development, research policy

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 6.9.2007 
COM(2007) 505 final 

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

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

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   EN 

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

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

Nanotechnology  provides  important  potential  for  boosting  quality  of  life  and  industrial 
competitiveness in Europe. Its development and use should not be delayed, unbalanced or left 
to chance. The European Commission (EC) plays two important roles in the development of 
nanosciences and nanotechnologies (N&N); as policy maker and as funding body for research 
and innovation. The “integrated, safe and responsible approach” proposed by the EC in 20041 
has  been  agreed  by  stakeholders  and  is  now  the  core  of  the  EU's  nanotechnology  policy. 
Resources have been mobilised and challenges addressed, as called for by the EC. The Action 
Plan2  provided  impetus  for  developments,  and  progress  in  almost  every  area  has  been 
identified. While it is difficult to collect all quantitative indicators for the period 2005-2007, a 
positive impact can nonetheless be seen. Over the last two years, European research in N&N 
has  benefited  from  considerable  financial  support,  complemented  by  increased  coordination 
and coherence in relevant policy areas. EU Institutions, Member States, industry, researchers 
and  other  interested  parties  have  worked  together,  sharing  information  and  regularly 
consulting  one  another,  so  that  by  and  large,  Europe  has  been  “talking  with  one  voice”. 
Efforts have also been made to work more closely with international partners, bi- and multi-
laterally. 

International  competition  increased  markedly  during  2005-2007,  challenging  European 
progress.  Some  weaknesses  are  becoming  apparent  in  Europe,  in  particular  a  shortage  of 
private  investment  in  research  and  industrial  innovation,  a  lack  of  leading  interdisciplinary 
infrastructures, and an increasing risk of duplication and fragmentation in research efforts due 
to  rising  investment  by  the  Member  States.  Such  potential  duplication  and  fragmentation 
should be avoided, and coherence, synergy and subsidiarity should feature in all EU actions. 
Furthermore,  by  its  own  interdisciplinary  and  novel  nature,  nanotechnology  may  challenge 
established approaches in research, education, patenting and regulation. In the coming years, 
activities  should  be  consolidated,  building  on  the  existing  momentum,  and  paying  special 
attention to the development of interdisciplinary infrastructures; appropriate conditions for the 
safe and effective use of nanotechnology; and a shared understanding of the responsibility of 
researchers within an ethical framework. 

This report summarises the actions taken and progress made during 2005-2007 in relation to 
the key areas identified in the N&N Action Plan for Europe 2005-2009. 

1 
2 

Towards a European Strategy for Nanotechnology, COM(2004)338 
Nanosciences and nanotechnologies: An action plan for Europe 2005-2009, COM(2005)243 

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1. 

RESEARCH,  DEVELOPMENT  AND  INNOVATION:  EUROPE  NEEDS 
KNOWLEDGE 

Support for research and technological development (R&D) came from both the EC and EU 
Member  States,  with  particular  emphasis  on  coordination  of  policies,  programmes  and 
projects. Under the 6th Research Framework Programme (FP6, 2002-2006) funding of almost 
EUR  1.4  billion  was  provided  to  more  than  550  projects  in  N&N.  By  contrast,  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 in 
Europe for N&N. 

Global expenditure in N&N, both public and private, in the period 2004-06 was around EUR 
24  billion.  Europe  accounts  for  more  than  a  quarter  of  this  worldwide  total,  with  the  EC 
funding directly accounting for 5-6%. 

In  terms  of  public  funding,  Europe  has  become  the  largest  investor  worldwide.  In  terms  of 
private  funding,  however,  Europe  is  at  a  significant  disadvantage  to  the  US  and  Japan.  The 
EU  has  set  a  target  of  investing  3%  of  its  GDP  in  R&D,  with  two-thirds  coming  from 
industry. However, private spending on R&D currently accounts for about 55% and this trend 
is also visible in the nanotechnology sector. On the other hand, the private sector is making 
progress in this area, as part of its activities in the different European Technology Platforms 
(ETPs) and its various contributions highlighted elsewhere in this document. 

Under  FP7,  EC  funding  for  N&N  is  expected  to  increase  significantly.  The  average  yearly 
funding  is  likely  to  be  more  than  double  that  in  FP6.  This  is  thanks  to  increases  in  the 
“Cooperation” specific programme and the significant reinforcement of “bottom-up” actions 
in the “Ideas” and “People” specific programmes. Funding in the latter is almost four times 
that in the corresponding activities of FP6 (NEST and Marie Curie). In addition to this overall 
growth, the growing interest in N&N may increase the share of the funding from “bottom-up” 
actions. Additional funding may come from the cross-thematic approaches developed in FP7, 
as  nano-,  bio-  and  information  technologies  have  an  interdisciplinary  character  and  can 
contribute  to  different  industrial  sectors  and  policy  objectives  (e.g.  in  health,  food,  energy, 
environment and transport). 

impact 

The first calls for proposals under FP7, published in December 2006, included almost 60 calls 
and  topics  directly  relevant  to  N&N,  in  the  broad  areas  of  nanosciences,  technology 
issues,  nanomaterials,  nanoelectronics, 
development, 
nanomedicine, as well as training and European Research Council (ERC) grants. Moreover, 
direct R&D actions related to N&N, in areas such as nanomaterials, nanobiotechnology, risk 
assessment and metrology, have been included in the Multi-Annual Work Programme of the 
Commission’s Joint Research Centre (DG JRC). 

assessment, 

societal 

Research  into  the  potential  impact  of  nanotechnologies  on  health  and  the  environment  has 
been boosted, with emphasis on capacity building. Some EUR 28 million from FP5 and FP6 
has  been  dedicated  to  projects  expressly  focused  on  environmental  and  health  aspects  of 
N&N.  Such  research  will  significantly  increase  in  FP7,  both  in  size  and  scope,  subject  to 
absorption  capacity.  Relevant  topics,  selected  after  a  public  consultation  in  2006,  were 
included in the first calls. 

Several  European  Technology  Platforms  (ETPs)  are  dedicated 
to  nanotechnology 
applications, such as Nanoelectronics (ENIAC),3 Nanomedicine4 and Sustainable Chemistry, 

3 
4 

http://www.eniac.eu/ 
http://cordis.europa.eu/nanotechnology/nanomedicine.htm 

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and  have  produced  vision  papers  and  strategic  research  agendas.  Other  ETPs  particularly 
relevant to N&N include Advanced Engineering Materials and Technologies, Hydrogen and 
Fuel  Cell  Technology,  Industrial  Safety  (Nanosafety  hub)  and  Photonics21,  which  includes 
nanophotonics and nanobiophotonics. ETP priorities are being taken on board in FP7 calls for 
proposals. 

The  FP6  ERA-NET  scheme  supports  the  coordination  of  national  research  programmes,  for 
example Nanoscience Europe (NanoSci-ERA), Micro- and Nanotechnology (MNT ERA-Net) 
and  Materials  Science  and  Technology  (MATERA).  This  scheme  will  be  continued  in  FP7 
and boosted with the introduction of the ERA-NET Plus.5 The first calls include an ERA-NET 
Plus for nanosciences. COST, the intergovernmental network for cooperation in science and 
technology, has also played a valuable role in nanoscience coordination, as demonstrated by 
the  European  Nanoscience  Forum  organised  in  October  2006  by  the  EC,  COST,  ESF,  the 
European  Parliament's  STOA  (Scientific  and  Technological  Options  Assessment)  and 
Nanoscience Europe. 

2. 

INFRASTRUCTURE AND EUROPEAN POLES OF EXCELLENCE 

The availability of infrastructures of excellence, critical mass and interdisciplinary character 
is a major challenge for the future progress of R&D and industrial innovation in Europe. 

The EC has supported N&N research infrastructures in FP6 (with EUR 40 million) and this 
support  will  continue  in  FP7,  in  the  “Capacities”  specific  programme.  This  is  for  access  to 
existing infrastructures and the development of future infrastructures, but does not extend to 
their construction. That responsibility lies mainly with the Member States. In September 2006 
the  European  Strategy  Forum  on  Research  Infrastructures  (ESFRI)  adopted  its  roadmap, 
which provides vital planning input to the EC and Member States. It identified 35 projects in 
all  areas,  including  a  Pan  European  Infrastructure  for  Nanostructures  and  Nanoelectronics 
(PRINS).  The  appropriateness  of  a  novel  infrastructure  in  nanobiotechnology  is  being 
explored. 

The integration of existing resources and expertise has also benefited considerably from ETPs 
and collaborative R&D projects, most notably networks of excellence, which may well lead to 
new European infrastructures (e.g. the Nanoquanta6 and Nano2Life7 networks). This indirect 
effect  on  capacity  building  is  expected  to  continue  in  FP7,  in  the  “Cooperation”  specific 
programme. 

3. 

INTERDISCIPLINARY  HUMAN  RESOURCES:  EUROPE  NEEDS 
CREATIVITY 

N&N  often  benefit  greatly  from  interdisciplinary  approaches,  which  may  challenge  more 
traditional education and training schemes. New goods, services and production methods will 
determine the demand for new and different jobs. A workshop dedicated to the education and 
research training needs for N&N was held in Brussels in April 2005. 

The Commission has been active in this area, with both its educational programmes (managed 
by  DG  Education  and  Culture)  and  schemes  for  the  mobility  and  training  of  researchers 

5 

6 
7 

In this scheme the EC contributes to both coordination and the funding of the joint trans-national call, 
up to 1/3 of the total. 
http://www.nanoquanta.eu/ http://www.etsf.eu/ 
http://www.nanotolife.com/ 

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(managed by DG Research). These forms of support are expected to increase in the coming 
years. 
Within  Erasmus  Mundus,  Masters  Degrees  in  some  areas  of  N&N  have  been  developed.8 
There has also been significant support for training in N&N through the Marie Curie actions 
of FP6, with grants of EUR 161 million, some 8% of their total budget. 

As to prizes for work in N&N, three of the 20 Marie Curie Awards of FP6 (EUR 50,000 each) 
were given to researchers for their work in N&N. In some Member States (e.g. Germany and 
Italy), dedicated awards have been introduced. It thus seems unnecessary for the EC to create 
a dedicated award. 

Training activities in N&N are expected to be funded under the “People” programme of FP7 
(e.g. Initial Training Networks), as they were under FP6. Education and training are also often 
addressed as part of collaborative R&D projects and networks of excellence (e.g. Nanobeams 
created  a  European  PhD  School  focusing  on  characterisation  techniques  using  ions  and 
electrons). The role of women in N&N is the focus of a dedicated FP6 project. 

N&N has also attracted the interest of the young, as evidenced by strong participation in EC-
funded  and  other  EU  activities,  such  as  the  German  NanoTruck.  The  Commission  has  also 
published a set of slides in 20 languages so far, which proved popular in schools as a tool for 
explaining N&N.  

4. 

INDUSTRIAL INNOVATION: FROM KNOWLEDGE TO THE MARKET 

A  specific  goal  of  the  Commission's  actions  in  N&N  is  to  improve  the  competitiveness  of 
European industry. This is done primarily by generating knowledge, to move from a resource-
intensive  industry  to  a  knowledge-intensive  one.  It  is  also  done  by  bringing  about  step 
changes through research and supporting the development of new applications resulting from 
the  interplay  of  different  technologies  and  disciplines.  Industrial  innovation  presents  some 
inertia and one role of public authorities is to implement measures to overcome it. 

The  Commission  is  encouraging  the  participation  of  industry,  and  SMEs  in  particular,  in 
collaborative  R&D  projects  in  FP7,  as  in  FP6.  FP6  saw  a  marked  increase  in  the  industrial 
participation  in  NMP  projects  related  to  N&N,  from  18%  in  2003-2004  to  37%  in  2006.  In 
FP7, there is more emphasis on meeting the R&D needs of industry, for example by taking on 
board  elements  from  the  strategic  research  agendas  of  ETPs.  In  the  case  of  manufacturing 
nano-chips,  a  joint  technology  initiative  (JTI)  has  been  proposed,  building  on  the  work  of 
ENIAC in nanoelectronics.  

New  important  measures  are  being  introduced  to  foster  industrial  innovation:  The  Risk 
Sharing  Finance  Facility,  undertaken  by  the  European  Investment  Bank  with  FP7  support, 
will  improve  access  to  debt  finance  for  participants  in  R&D  projects.  The  Guarantee  Fund 
(combined with new financial liability rules) in FP7 will facilitate the participation of SMEs 
in  particular.  The  “Competitiveness  and  Innovation  Programme  2007-2013”  (CIP),  with  a 
budget  of  about  EUR  3.6  billion,  will  also  support  innovation  through  three  specific 
programmes,  all  potentially  relevant  to  innovation  based  on  N&N  (Entrepreneurship  and 
Innovation  Programme;  ICT  Policy  Support  Programme;  and  Intelligent  Energy-Europe 
Programme). 

8 

http://www.emm-nano.org/ 
http://www.u-picardie.fr/mundus_MESC/ 
http://www.ens-cachan.fr/monabiphot/ 

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Additional services are being offered to consortia, such as the exploitation strategy seminars 
for projects funded under the NMP priority, to help them capitalise on their research results. 
Throughout Europe, several events have been organised to stimulate the interest of industry, 
such as the EuroNanoForum 2007 in Düsseldorf; or the Nano2Business workshops in Warsaw 
and Helsinki, both organised by the Nanoforum project. 

The  development  of  roadmaps  leading  to  industrial  applications  (e.g.  of  nanomaterials)  has 
been  supported  in  FP6  by  a  wide  dissemination  of  their  findings  to  European  industry  (e.g. 
NanoRoadSME and NanoRoadMap). This activity has reinforced the work done by the ETPs, 
for  example  ARTEMIS  (embedded  computing  systems),  ENIAC  (nanoelectronics),  EPoSS 
(smart  systems  integration),  FTC  (future  textiles  and  clothing),  ManuFuture  (future 
manufacturing  technologies),  NanoMedicine,  Industrial  Safety  and  SusChem  (sustainable 
the  Working  Group  on  Micro-  and  Nano- 
chemistry).  Further  examples 
Manufacturing  (MINAM)  and  the  MNT  ERA-Net  in  the  same  field.  The  CONCORDE-
NSOCRA coordination action on nano-structured oxide catalysts clearly showed the positive 
impact of N&N on the energy efficiency of industrial processes and the environment. 

include 

The opportunities and risks for future developments of N&N in Europe must be understood. 
To do so, the markets for nanotechnology products; the composition of the industries affected; 
the  competitiveness  of  European  industry;  the  implications  of  the  societal  and  safety 
dimensions;  and  the  barriers  hampering  development  must  be  examined.  The  JRC  is 
coordinating  a  socio-economic  study  related  to  these  fields.  This  study  will  build  upon  the 
output of FP6 projects and other activities outlined above. 

There  is  an  important  role  for  standardisation  at  European  and  international  level.  The 
Commission (primarily through the JRC) plays an important guiding role in the activities of 
standardisation bodies, namely CEN and ISO.  

The Commission has also given mandates for actions to the European standards bodies CEN, 
CENELEC and ETSI. To ensure transparency and a coordinated position among EU national 
authorities,  the  EC  adopted  a  mandate  in  April  2007  inviting  these  bodies  to  present  a 
standardisation programme. This is expected by the end of 2007 and should take account of 
the  need  for  a  revision  of  existing  standards  or  the  development  of  new  ones,  in  relation  to 
health,  safety  and  environmental  protection.  Several  aspects  (e.g.  the  development  of 
nomenclature,  standard  test  methods)  require  international  collaboration  to  ensure  the 
compatibility of scientific data and international harmonisation of scientific methods used for 
regulatory purposes. The mandate therefore clearly expresses the idea that European standards 
be developed in cooperation with ISO, the international standards body. 

Pre-normative R&D (that is, R&D supporting standards and metrology) has been supported in 
FP6 (e.g. Nanostrand and Nanotransport) and further support will be provided in FP7 (e.g. for 
the coordination of nanometrology). This coordination at European level will be extended and 
harmonised through global fora such as VAMAS (pre-normative) and CIPM (metrology). 

The  European  Patent  Office  (EPO)  is  facing  the  challenges  presented  by  the  registration  of 
nanotechnology applications, and has introduced a “nano tagging”. Collaboration between the 
Commission and EPO has increased, leading to the jointly organised international workshop 
“IPR in Nanotechnology” in April 2007. 

Regarding  patents,  a  preliminary  comparison  of  FP5  and  FP6  indicates  that  patent 
applications originating from N&N projects (in Growth and NMP) more than doubled in the 
first  two  years  of  FP6.  In  FP7,  the  scale-up  of  promising  technological  solutions  will  be 
supported with dedicated funding, such as nanotechnology-based pilot lines. 

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5. 

INTEGRATING 
EXPECTATIONS AND CONCERNS 

THE 

SOCIETAL 

DIMENSION: 

ADDRESSING 

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  safely  applied  and  produce  results  in  the 
shape  of  useful  products  and  services,  but  there  should  also  be  public  consensus  on  their 
overall impact. Their expected benefits, as well as potential risks and any required measures, 
must be fully and accurately presented and public debate must be encouraged, to help people 
form an independent view. The Commission has played a pivotal role in this area. 

The  Commission  has  funded  or  directly  published  a  wide  range  of  information  material  in 
many  languages  and  for  various  age  groups,  including  films.  The  intention  is  that  at  least 
basic information be available in the EU languages. Undoubtedly there is a role for scientists 
here, who can explain the principles and applications of nanotechnology to the general public 
and the press. To support them in these public outreach activities, the Commission has made 
available  the  handbook  “Communicating  Science,  a  Survival  Kit  for  Scientists”.  Two  web 
sites,  http://ec.europa.eu/nanotechnology/  and  http://www.nanoforum.org,  are  a  useful 
resource. Studies on social acceptance have been carried out through dedicated projects within 
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. 
Results and recommendations were presented at an open final conference in February 2007. 
Other projects such as NanoBio-RAISE are continuing with this public dialogue, and support 
for further actions in this field is expected in FP7. 

The methodology of public dialogue in nanotechnology was examined during an international 
workshop  in  February  2007,  involving  science  communicators.  A  final  report  will  be 
published, taking into account the input received. 

Potential  ethical  issues  were  examined  for  all  R&D  projects  considered  under  FP6,  with 
ethical  reviews  carried  out  where  appropriate.  This  practice  will  continue  in  FP7.  The 
European Group on Ethics in Science and New Technologies (EGE), an advisory body to the 
EC  President,  delivered  an  opinion  on  nanomedicine  in  January  2007.9  The  opinion 
recognises  the  potential  of  nanomedicine  in  developing  new  diagnostic,  treatment  and 
preventive  methods.  It  places  emphasis  on  conducting  research  both  into  the  safety  and  the 
ethical, legal and societal aspects of nanomedicine. It proposes setting up a European network 
on the ethics of nanomedicine and suggests further monitoring of the current legal situation, 
but does not call for specific legislation at this stage. These points will be taken on board in 
FP7. 
Commission10  and  other  surveys  indicated  that  much  of  the  European  public  is  still  not 
sufficiently  aware  of  N&N.  However,  these  surveys  also  show  that  public  confidence  in 
European public authorities’ ability to ensure good governance for nanotechnology is higher 
in Europe than elsewhere. 

9 
10 

http://ec.europa.eu/european_group_ethics/avis/index_en.htm 
http://www.ec.europa.eu/research/press/2006/pdf/pr1906_eb_64_3_final_report-may2006_en.pdf 

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Member States and international organisations have also been active in this field and various 
initiatives have taken place, such as by Greenpeace and Demos in the UK, and Vivagora in 
France. 

With  the  intention  to  strengthen  a  culture  of  responsibility,  the  EC  has  launched  a  public 
consultation  to  contribute  to  the  definition  of  some  basic  principles  for  the  responsible 
governance  of  nanotechnology  research.  The  “Augsburg  Materials  Declaration”  and  the 
position taken by Degussa GmbH already reflect this intention. 

6. 

PUBLIC  HEALTH,  SAFETY,  ENVIRONMENTAL  AND  CONSUMER 
PROTECTION 

While  N&N  offer  a  number  of  beneficial  applications,  the  potential  impact  on  the 
environment and human health of certain “nanomaterials” and “nanoproducts” is not yet fully 
understood. The overarching aim of the Commission’s work in the area of health, safety and 
the environment is to enable the safe development and use of N&N and ensure that the public 
can benefit from the innovations that they may bring, while being protected from any adverse 
impacts. 

Different approaches, both regulatory and non-regulatory, are being pursued to do this:  

– 

– 

– 

Examining  whether  current  legislative  frameworks  offer  sufficient  protection,  or 
whether modifications or new legislation is needed. 

Improving  the  knowledge  basis,  via  research,  scientific  committees,  information 
sharing and cooperation, including at international level. 

Involving the public through stakeholder dialogues, voluntary initiatives etc.  

6.1. 

Regulatory review 

The  Commission  is  finalising  a  review  of  current  regulation,  to  establish  whether  new 
regulatory  action  is  required  to  cover  risks  in  relation  to  nanomaterials.  Its  initial  finding  is 
that  current  regulation  addresses  in  principle  concerns  about  health  and  environmental 
impacts.  On  the  basis  of  scientific  developments  or  regulatory  needs  in  specific  areas, 
regulatory changes may be proposed. In the course of this exercise, the EC will take account 
of reports on regulatory gaps produced in various Member States. 

Having  said  that,  the  primary  means  to  protect  health,  safety  and  the  environment  is  by 
improving the implementation of current regulation. National authorities and the Commission 
must  therefore  first  ascertain  whether  it  is  necessary  to  update  current  texts,  such  as 
implementing  legislation,  standards  and  technical  guidance,  with  regard  in  particular  to  risk 
assessment.  In  the  meantime,  and  in  the  light  of  the  continuous  generation  of  new  data, 
existing methods will continue to be used on a case by case basis. Where necessary, existing 
regulatory mechanisms should be used, in relation to thresholds, authorisation of substances 
and  ingredients,  qualification  of  waste  as  hazardous,  reinforcing  conformity  assessment 
procedures,  introducing  restrictions  on  the  marketing  and  use  of  chemical  substances  and 
preparations, and so on. 

Particular attention must also be given to the various mechanisms that allow authorities and 
agencies  in  charge  of  implementing  legislation  to  intervene,  through  measures  such  as 
safeguard clauses and warning systems, in case risks are identified for products already on the 
market. 

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Finally,  authorities  will  have  to  ensure  that  regulatory  priorities  are  covered  by  calls  for 
proposals  under  FP7  and  that  the  outcome  of  research  is  scrutinised  for  its  regulatory 
usefulness. 

6.2. 

Addressing knowledge gaps 

Since 2005, a global consensus has emerged on the urgent need for scientific knowledge of 
the  safety  aspects  of  manufactured  nanomaterials.  Priorities  were  identified,  at  national,  EU 
and international level, and were addressed by a number of initiatives: 

– 

– 

– 

Data  on  potential  risks  to  humans  and  the  environment,  as  well  as  test  methods  to 
generate them. 

Data on exposures throughout the life cycle of nanomaterials or products containing 
them; and exposure assessment methods. 

Measurement,  characterisation  methods  for  nanomaterials,  reference  materials,  and 
sampling and analytical methods to deal with exposures. 

On  10  March  2006,  at  the  Commission’s  invitation,  the  Scientific  Committee  on  Emerging 
and Newly Identified Risks (SCENIHR) adopted after public consultation an opinion on risk 
assessment  in  relation  to  nanotechnologies.11  According  to  the  SCENIHR,  although  the 
existing  toxicological  and  ecotoxicological  methods  are  appropriate  to  assess  many  of  the 
hazards associated with nanoparticles, they may not be sufficient to address all the hazards. 
Because  of  uncertainties,  the  current  risk  assessment  procedures  require  modification  for 
nanoparticles.  Knowledge  gaps  have  been  confirmed  in  areas  such  as  nanoparticle 
characterisation,  detection  and  measurement;  their  fate  and  persistence  in  humans  and  the 
environment; and all aspects of the associated toxicology and ecotoxicology. These should be 
addressed to allow satisfactory risk assessments for humans and ecosystems. 

The EC therefore requested the SCENIHR to carry out a more detailed analysis of the current 
risk  assessment  methodology  as  laid  down  in  the  Technical  Guidance  Documents  for 
chemicals, and its  opinion was adopted after public consultation on 21-22 June 2007.12 The 
SCENIHR concluded that, while the current methodologies are generally likely to be able to 
identify  the  hazards  associated  with  the  use  of  nanoparticles,  modifications  of  the  existing 
guidance  will  be  necessary.  It  identifies  issues  requiring  improvements  in  the  technical 
guidance  and  methodologies,  and  proposes  a  staged  strategy  for  the  risk  assessment  of 
nanomaterials. 

As to cosmetics, the EC invited the Scientific Committee on Consumer Products (SCCP) to 
review  and  if  appropriate  amend  its  Notes  of  Guidance  for  the  testing  of  ingredients  and  to 
evaluate the safety of cosmetic ingredients in the form of nanoparticles.13 The SCCP approved 
an opinion for public consultation on 19 June 2007,14 concluding that it is necessary to review 
the safety of the nanomaterials presently used in sunscreens in the light of recent information; 
and stressing the possible influence of physiologically abnormal skin and mechanical action 
on skin penetration. 

6.3. 

Research on safety aspects 

Research on  safety aspects  is  expressly addressed  by EC funding for N&N (section  1).  The 
general  aim  is  to  support  the  scientific  assessment  of  the  potential  health,  safety  and 

11 
12 
13 
14 

http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_010.pdf 
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_nano_en.pdf 
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_099.pdf 

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environmental  risks  associated  with  nanotechnology-based  materials  and  products,  at  the 
earliest  possible  stage,  to  close  knowledge  gaps  and  provide  a  basis  for  meeting  regulatory 
requirements.  If  the  need  arose,  this  research  could  contribute  to  the  development  of  new 
requirements for a safe, responsible and sustainable development of N&N. Topics in the first 
call  for  proposals  of  FP7  include  easy-to-use  portable  devices;  the  impact  of  engineered 
nanoparticles on health and the environment with a critical review of the data; a commented 
database  on  nanoparticle  impact;  coordination  in  studying  the  impact  of  nanotechnology-
based  materials  and  products;  and  alternative  strategies  for  the  toxicological  assessment  of 
nanoparticles used in medical diagnostics. 

The JRC, meanwhile, is focusing on the development and harmonization of methods for the 
characterization  and  toxicity  testing  of  manufactured  nanomaterials  (e.g.  particle  size 
measurements, in vitro testing of a representative set of nanomaterials on critical cell lines); 
related  studies  on  reference  materials  and  dosimetry;  studies  on  the  applicability  of 
computational methods for assessing nanoparticle properties, including toxicity; and database 
development. 

Several  documents  were  produced  in  the  context  of  the  ETP  on  Sustainable  Chemistry 
(SusChem),15  such  as  a  code  of  conduct  on  nanotechnology;  a  guide  on  safe  manufacturing 
and  activities 
information  on 
involving  nanoparticles  at  workplaces;  and  detailed 
nanomaterial characterisation. The Nanosafety Hub event held in Brussels in March 2007 by 
the ETP on Industrial Safety (ETPIS)16 looked at progress in monitoring technologies related 
to  nanoparticle  toxicity;  and  workplace  and  environmental  safety  in  connection  with 
nanomaterials. In this context, it is also important to note voluntary approaches by industry17 
in publishing guides on the safe manufacturing and handling of nanomaterials at workplaces. 

6.4. 

International collaboration in the health and environment area 

Several  safety  aspects  require  international  collaboration,  such  as  the  development  of 
common  nomenclature,  standards  and  test  methods,  to  ensure  that  data  can  be  compared 
globally and that methods used for regulatory purposes are internationally harmonised. 

A  principal  forum  for  the  coordination  of  activities  at  the  international  level  has  been 
provided by the OECD Working Party on Manufactured Nanomaterials.18 This has a working 
programme with six specific projects, tackling inter alia knowledge gaps with regard to health 
and environmental impact, databases, test systems, guidelines, risk assessment methodologies, 
and  the  exchange  of  information  on  voluntary  schemes  and  regulatory  approaches.  The 
Commission, with the support of its Scientific Committees, as well as other European bodies, 
is expected to continue contributing to these international efforts. 

Also  important  are  the  activities  in  ISO/TC  229  to  develop  standard  methods  and 
nomenclature, in which the EC and Member States are already actively involved. 

FP7 funding has been opened to research teams from virtually all countries in the world. The 
possibility  of  a  coordinated  call,  joining  research  efforts  on  both  sides  of  the  Atlantic,  has 
been intensively discussed with various US Federal Agencies. It is therefore welcome that the 
US Agencies EPA, NSF and DoE on their part launched a joint solicitation encouraging US 

15 
16 
17 
18 

www.suschem.org 
www.industrialsafety-tp.org 
e.g. Basf and Bayer 
http://www.oecd.org/about/0,3347,en_2649_37015404_1_1_1_1_37465,00.html 

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researchers  to  collaborate  with  European  teams.19  The  recommendation  to  European 
researchers to work with US teams was included in the first call for proposals of FP7. 

A  workshop  on  the  life  cycle  assessment  of  nanotechnology-based  products  was  jointly 
organised  by  the  Commission,  the  US  Environmental  Protection  Agency  (EPA)  and  the 
Woodrow Wilson International Centre for Scholars in October 2006.20 

7. 

INTERNATIONAL COOPERATION 

In line with the mandate received from the EU Council in September 2004, the Commission 
has  intensified  the  dialogue  on  nanotechnology  at  international  level,  at  both  bi-  and  multi-
lateral  levels,  conforming  to  the  principle  of  subsidiarity.  This  involves  economically  and 
industrially advanced countries (to  share knowledge and profit  from critical mass), and also 
those less advanced (to secure their access to knowledge and avoid any “nano divide”).  

In  R&D,  cooperation  appears  particularly  promising  in  nanosciences  and  nanomaterials,  as 
well as in selected targeted fields, such as nanoparticle safety, or actions paving the way to a 
level  playing  field  for  nanotechnology-based  products  in  the  globalised  market  (e.g.  pre-
normative  research).  The  EC  has  been  attentive  to  inputs  from  non-EU  or  international 
stakeholders,  such  as  from  the  initiative  “Nanotechnology  and  the  Poor:  Opportunities  and 
Risks” of the Meridian Institute. 

FP7 – to an even greater extent than FP6 – is open to researchers from outside the EU, with 
EU funding in the case of most countries. Dedicated pilot actions have been launched, such as 
NanoForum  EU-Latin  America  and  EuroIndiaNet.  The  mobility  of  researchers  and  mutual 
access to top infrastructures are also addressed. 

The possibility of a “code of good conduct” for the responsible development and use of N&N 
has  been  explored  at  international  level,  but  there  has  not  been  unanimous  worldwide 
agreement  on  the  Commission's  proposals.  As  mentioned  above,  the  Commission  has 
launched a public consultation addressing basic principles for the responsible governance of 
nanotechnology research, in which third countries may be interested in participating. 

A dedicated international dialogue has been launched with meetings in Alexandria (USA) in 
2004 and Tokyo in 2006, and two preparatory meetings in Brussels and Cape Town. The third 
international dialogue is planned for 2008 in Europe. 

The Commission’s action has included the following: 

– 

– 

– 

Participating  in  CEN  and  ISO,  where  new  groups  have  been  created  on  N&N 
standards  (CEN/TC  352  and  ISO/TC  229),  and  existing  groups  have  taken  up 
specific related work items (e.g. ISO/TC 24, ISO/TC 146). 

Participating in OECD, where two new Working Parties have been established: the 
OECD-WP  on  Manufactured  Nanomaterials,  under  the  Joint  Chemicals  Meeting 
(section 6); and the OECD-CSTP-WP on Nanotechnology.21 

Addressing  in  FP7  research  on  the  impact  of  nanoparticles  on  health  and  the 
environment in consultation and/or coordination with US Federal Agencies; the EC 

19 
20ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/lca_nanotechnology_workshopoct2006_proceedings_en.pd

http://es.epa.gov/ncer/rfa/2007/2007_star_nanotech.html 

21 

f 
www.oecd.org/sti/nano 

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and  Environment  Protection  Agency  have  concluded  an  implementing  arrangement 
which includes nanotechnology. 

Providing  in  FP7  support  for  the  networking  of  researchers  from  third  countries  in 
nanotechnology  and  the  creation  of  a  free  and  open  electronic  archive  of  N&N 
publications, to help prevent a possible “nano divide”. 

Creating  an  ad-hoc  working  group  with  Member  State  representatives  to  examine 
progress and challenges for international activities specific to nanotechnology. 

IMPLEMENTING  A  COHERENT  AND  VISIBLE  STRATEGY  AT 
EUROPEAN LEVEL 

– 

– 

8. 

The purpose of the Action Plan is to ensure the best possible governance of the development 
and  use  of  nanotechnology.  Its  effective  implementation  therefore  requires  an  efficient 
structure and coordination, within a detailed and regular consultation with the Member States 
and all stakeholders. 

The Commission has cooperated with the EU Presidencies in the organisation of conferences 
providing  opportunities  to  verify  progress.  In  2005,  the  UK  hosted  the  EuroNanoForum 
conference.  The  UK  Presidency  also  organised  a  Member  State  workshop  to  discuss  and 
examine  the  initial  progress  of  the  implementation  of  the  Action  Plan.  This  event  was 
followed  up  by  the  Austrian  Presidency  in  June  2006;  and  by  the  Finnish  Presidency  in 
September 2006, with the conference “Nanotechnologies: Safety for Success”.22 The German 
Presidency  organised  the  EuroNanoForum  conference  in  June  2007,  and  the  Portuguese 
Presidency plans to organise an official event in November 2007. 

An  EC  Interservice  Group  dedicated  to  all  aspects  of  the  work  described  in  this  report  has 
been established. The Commission has also issued a call for the creation of an observatory, to 
carry  out  dynamic  assessments  of  nanotechnology  development  and  use;  this  should  enable 
stakeholders  to  understand  the  potential  and  critical  issues,  providing  an  “early  warning” 
function to the EU Institutions and Member States. 

A new Europa website presents the implementation work carried out by all the Commission 
services involved: http://ec.europa.eu/nanotechnology/ 

In  a  broader  sense,  the  Action  Plan  is  also  a  means  to  ensure  that  N&N  contribute  to  the 
realisation of the European Research Area (ERA),23 and the following achievements may be 
noted in this respect: 

– 

– 

22 
23 

The broad-ranging European strategy for N&N and the fact that EC funding accounts 
for  a  third  of  European  public  funding  in  N&N  have  resulted  in  effective 
coordination  and  the  minimisation  of  overlaps.  Another  helpful  factor  has  been  the 
early launching of these initiatives, often before any structured initiatives by Member 
States (section 1 above). 

Funded projects dedicated to the training and mobility of researchers, and other R&D 
projects in N&N, have contributed to the creation of high quality human potential in 
N&N (section 3 above). 

http://www.fmnt.fi/ntss/ 
Towards a European research area, COM(2000)6 

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– 

– 

– 

– 

FP6  has  seen  increasing  industrial  participation  in  R&D  projects  on  N&N,  and  the 
creation of several ETPs has strengthened public-private cooperation in N&N. FP7 is 
expected to lead to further progress (section 4 above).  

Several  strategic  activities  have  been  carried  out  to  engage  the  public  (section  5 
above). 

Selected  strategic  activities  focusing  on  international  collaboration  are  being 
undertaken  (section  7  above).  There  is  also  a  small  but  increasing  participation  of 
international partners in R&D projects in N&N. 

These activities have been complemented by wide-ranging efforts to enable the safe 
development and use of nanotechnologies (section 6 above). 

In the coming years, special attention should be paid to the development of interdisciplinary 
infrastructures; appropriate conditions for the safe and effective use of nanotechnology; and a 
shared understanding of the responsibility of researchers within an ethical framework. 

To promote safe and responsible nanotechnology research and pave the way for its safe and 
responsible  application  and  use,  the  Commission  is  planning  to  adopt  a  voluntary  Code  of 
Conduct for Responsible N&N Research. 

Following its review of current legislation, the Commission may propose regulatory changes, 
on the basis of scientific developments, or regulatory needs in specific areas where such needs 
may be identified. 

The Commission intends to submit the next implementation report on the N&N Action Plan 
by the end of 2009. 

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