Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee - Nanosciences and nanotechnologies- an action plan for Europe 2005-2009
Date: 2005-06-07
Institutions: European Commission
Subjects: applied research, atom, fundamental particle, new technology, research and development, research policy, scientific research

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 7.6.2005 
COM(2005) 243 final 

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

Nanosciences and nanotechnologies: 
An action plan for Europe 2005-2009 

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BACKGROUND 

Nanosciences  and  nanotechnologies  (N&N)  are  new  approaches  to  research  and 
development  (R&D)  that  concern  the  study  of  phenomena  and  manipulation  of 
materials  at  atomic,  molecular  and  macromolecular  scales,  where  properties  differ 
significantly from those at a larger scale. 

Advances  across  a  wide  range  of  sectors  are  being  enabled  through  R&D  and 
innovation in N&N. These advances can address the needs of citizens and contribute 
to the Union’s competitiveness and sustainable development objectives and many of 
its policies including public health, employment and occupational safety and health, 
information society, energy, transport, security and space. 

Products based on N&N are already in use and analysts expect markets to grow by 
hundreds of billions of euros during this decade. Europe must avoid a repeat of the 
European  ‘paradox’  witnessed  for  other  technologies  and  transform  its  world-class 
R&D  in  N&N  into  useful  wealth-generating  products  in  line  with  the  actions  for 
growth and jobs, as outlined in the ‘Lisbon Strategy’ of the Union1. 

Health,  safety  and  environmental  risks  that  may  be  associated  with  products  and 
applications of N&N need to be addressed upfront and throughout their life cycle. 

A  better  dialogue  between  researchers,  public  and  private  decision-makers,  other 
stakeholders,  and  the  public  is  beneficial  for  understanding  possible  concerns  and 
tackling  them  from  the  standpoints  of  science  and  of  governance,  and  to  promote 
informed judgement and engagement. 

On 12 May 2004 the Commission adopted the Communication Towards a European 
Strategy  for  Nanotechnology2  in  which  a  safe,  integrated  and  responsible  strategy 
was proposed. This aims to reinforce the Union’s leading position in N&N R&D and 
innovation while addressing any environmental, health, safety and societal concerns 
upfront. In this context, several needs were highlighted: 

–  increase  investment  and  coordination  of  R&D  to  reinforce  scientific  excellence, 
interdisciplinarity and competition in N&N together with industrial exploitation; 

–  develop  world-class  competitive  R&D  infrastructure  (‘poles  of  excellence’)  that 

take into account the needs of both industry and R&D organisations; 

–  promote  the  interdisciplinary  education  and  training  of  R&D  personnel  together 

with a stronger entrepreneurial mindset; 

–  provide  favourable  conditions  for  industrial  innovation  to  ensure  that  R&D  is 

translated into affordable and safe wealth-generating products and processes; 

–  respect ethical principles, integrate societal considerations into the R&D process 

at an early stage and encourage a dialogue with citizens; 

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–  address  public  health,  occupational  health  and  safety,  environmental  and 

consumer risks of N&N-based products at the earliest possible stage; 

–  complement the above actions with appropriate cooperation and initiatives at the 

international level. 

In  its  conclusions  of  24  September  20043,  the  Competitiveness  Council  welcomed 
the proposed integrated and responsible approach and the Commission’s intention to 
draw  up  an  Action  Plan  for  nanotechnology.  The  European  Economic  and  Social 
Committee  subsequently  adopted  an  opinion  on  the  10  November  2004  that 
supported the Commission’s proposed approach4. 

All stakeholders were invited to provide their opinion on the Commission’s proposal 
via  an  extensive  open  consultation  that  closed  on  the  15  October  2004.  Over  750 
responses were received supporting the elements of the Commission’s proposal. The 
outcome of this survey, the largest of its kind in Europe, is described elsewhere5. 

Taking into account the above, the Commission has prepared this Action Plan, which 
defines  a  series  of  articulated  and  interconnected  actions  for  the  immediate 
implementation of a safe, integrated and responsible strategy for N&N based on the 
priority  areas  identified  in  the  above-mentioned  Communication.  As  far  as 
nanobiotechnology  is  concerned,  this  Action  Plan  complements  the  Commission’s 
Strategy for Europe on Life Sciences and Biotechnology.6 

The  Commission  invites  the  European  Parliament  and  the  Council  to  endorse  the 
Action Plan and invites the Member States to contribute to its rapid implementation. 

1. 

RESEARCH, DEVELOPMENT AND INNOVATION: EUROPE NEEDS KNOWLEDGE  

Bringing  together  public  and  private  organisations  across  Europe  to  perform 
collaborative R&D is key for the interdisciplinary approach often needed for N&N as 
well as for optimising resources. National and regional initiatives account for around 
two-thirds of overall European public investment in N&N R&D. N&N R&D should 
be  reinforced  and  coordinated  for  economies  of  scale  and  to  achieve  synergy  with 
education  and  innovation  generating  the  ‘triangle  of  knowledge’  needed  for  the 
European Research Area of knowledge for growth.7 

1.1  The Commission will: 

a) 
Reinforce N&N R&D in the European Union’s seventh framework programme 
for research, technological development and demonstration activities (FP7)8, 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; 

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Conclusions of the Competitiveness Council 24 September 2004 
Opinion of the European Economic and Social Committee 15 December 2004 
Nanoforum Report, December 2004 http://www.nanoforum.org 
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b) 
Propose specific support to research in nanoelectronics under the Information 
and  Communication  Technology  (ICT)  priority  of  FP7.  In  line  with  the  research 
agenda of the European Technology Platform on Nanoelectronics9, this will stimulate 
industrially-relevant  research  in  a  technologically  mature  field,  provide  the 
foundation  for  the  next  generation  of  electronics  and  enable  many  new  ICT 
applications, whilst drawing on complementary research in other thematic areas; 

c) 
Boost  support  for  collaborative  R&D  into  the  potential  impact  of  N&N,  in 
particular  engineered  nano-scale  entities  (e.g.  nanoparticles),  on  human  health  and 
the environment via toxicological and ecotoxicological studies as well as developing 
appropriate  methodologies  and  instrumentation  for  monitoring  and  minimising 
exposure in the workplace, including portable in situ measuring devices10; 

d) 
Foster  the  development  of  European  Technology  Platforms  in  order  to 
implement a strategic R&D agenda for N&N sectors that are important for Europe’s 
competitiveness e.g. in nanomedicine, sustainable chemistry or space (including the 
possibility of launching European Technological Initiatives). 

1.2  The Commission calls upon the Member States: 

a)  At policy level, to increase public investment in R&D in N&N, corresponding 
to increased R&D expenditure to match the ‘3%’ Barcelona objectives11. In line with 
the  subsidiarity  principle,  the  Commission  considers  the  ‘Open  Method  of 
Coordination’ to be an appropriate way to proceed with the utilisation of information 
exchange, indicators, and guidelines; 

b)  At programme level, to enforce effective coordination of R&D programmes at 
national  and  regional  levels,  which  could  minimise  duplication  and  achieve  greater 
efficiency  e.g.  via  the  ERA-NET  scheme  and  its  possible  successor.  Community 
participation in national programmes, as set out in EC Treaty Article 169, could have 
a significant impact; 

c)  At  project  level,  to  promote  N&N  R&D  activities  by  raising  awareness  in 
universities,  R&D  organisations  and  industry,  and  to  provide  support  for  their 
participation in projects at EU level (e.g. FP, COST, ESF, EUREKA) as well as for 
taking  advantage  of  loans  from  the  European  Investment  Bank  (EIB)  ‘Innovation 
2010’ initiative. 

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Vision  2020:  Nanoelectronics  at  the  centre  of  change  Report  of  the  High-Level  Group  EUR  21149 
(June 2004) http://www.cordis.lu/ist/eniac  
Research Needs on Nanoparticles, 25-26 January 2005 
http://www.cordis.lu/nanotechnology/src/pe_workshop_reports.htm#particles 
CREST  Report  on  the  open  method  of  coordination  in  favour  of  the  Barcelona  research  investment 
objective http://europa.eu.int/comm/research/era/3pct/pdf/3pct-app_open_method_coordination.pdf 

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2. 

INFRASTRUCTURE AND EUROPEAN POLES OF EXCELLENCE 

World-class R&D infrastructure and ‘poles of excellence’ are essential for the EU to 
remain  competitive  in  N&N.  Europe  needs  an  appropriate,  diverse  but  coherent 
system  of  infrastructure  that  comprises  both  ‘single  sited’  (in  one  location)  and 
‘distributed’  (networked)  facilities.  However,  due  to  its  interdisciplinary,  complex 
and  costly  nature,  the  infrastructure  for  R&D  and  innovation  in  N&N  requires  a 
critical  mass  of  resources  that  are  beyond  the  means  of  regional  and  often  even 
national governments and industry. 

2.1  The Commission will: 

a) 
Establish a map of existing European N&N infrastructure and explore ways of 
maximising its added value by the exchange  of best  practice. Special attention will 
be  paid  to  the  needs  of  industry,  in  particular,  small  and  medium  sized  enterprises 
(SMEs)  so  to  reinforce  cooperation  with  and  technology  transfer  from  academic 
R&D  teams  to  conceive  advanced  prototypes  and  validate  them  in  industrially-
relevant environments; 

Support 

transnational  networking  and 

b) 
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 
support  EU 
competitiveness in this field. 

that  would 

2.2  The Commission calls upon the Member States: 

To  decide  upon  and  launch  the  construction  of  new  (or  the  substantial 
a) 
upgrading of existing) interdisciplinary infrastructure or ‘poles of excellence’ on the 
basis of roadmaps of future needs e.g. in nanobiotechnology. It is expected that the 
European  Strategy  Forum  on  Research  Infrastructure  (ESFRI)  will  provide  a 
valuable contribution through identifying the needs for infrastructure at Community 
level.  The  associated  financing  should  encompass  private  and  public  sources, 
including EC Treaty Articles 169 and 171, structural funds, the European Investment 
Bank (EIB) as well as taking into account the ‘Growth Initiative’12. 

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3. 

INTERDISCIPLINARY HUMAN RESOURCES: EUROPE NEEDS CREATIVITY 

Our  capability  to  generate  knowledge  depends  upon  the  up-to-date  education, 
training  and  lifelong  learning  of  researchers,  engineers  and  other  skilled  personnel. 
Interdisciplinary  R&D  in  N&N  goes  beyond  traditional  concepts  and  a  greater 
awareness  amongst  these  groups  of  entrepreneurship,  ethical,  health,  safety 
(including in the workplace), environmental, and social issues is needed. At the same 
time,  mobility  across  borders  and  disciplines  and  between  academia  and  industry 
improves the quality of education and training, particularly in N&N where progress 
is fast and interdisciplinarity plays a determinant role. 

3.1  The Commission will:  

a) 
Promote networking and disseminate best practices for education and training 
in N&N. A dedicated workshop is taking place in 2005 and the proceedings will be 
widely disseminated; 

b) 
Explore  how  to  best  encourage  the  development  of  relevant  supporting 
activities  (e.g.  cross-border  thematic  networks  and  other  actions),  in  particular 
through  its  programmes  and  specifically  the  proposed  new  generation  of  education 
and training programmes after 200613; 

Promote  the  creation  of  an  ‘interdisciplinary  European  award  in  N&N’  that 
c) 
recognises  scientific  advances  and  entrepreneurship  and/or  progress  in  the  area  of 
safety  and  the  environment,  in  line  with  the  integrated  and  responsible  approach. 
Sponsorship from industry and other interested organisations will be sought; 

d) 
Explore  the  possibility  for  dedicated  N&N  ‘Marie  Curie’  actions  (e.g. 
fellowships)  that  stimulate  transnational  doctorate-level  programmes.  Lifelong 
learning  for  researchers  and  engineers  will  also  be  promoted  by  actions  aimed  at 
disciplinary  and/or  sectorial  mobility.  Special  attention  will  be  paid  to  the 
participation of women and duly rewarding the hosting institutions. 

3.2  The Commission calls upon Member States: 

a) 
To foster interdisciplinary training and education for R&D in N&N, focusing 
on  physics,  chemistry,  biology,  toxicology  and  ecotoxicology  and  engineering,  but 
also  including  entrepreneurial  studies,  risk  assessment,  and  social  and  human 
sciences  where  appropriate.  Training  programmes  should  also  be 
targeted 
specifically at SMEs, who often lack the necessary ‘in house’ expertise or resources;  

b) 
To encourage students, researchers and engineers to take advantage of the wide 
range of initiatives for undertaking mobility and training in N&N, which is available 
at  national  and  European  levels,  including  the  Marie  Curie  actions,  the  European 
Science Foundation (ESF), and the Human Frontier Science Program (HFSP). 

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4. 

INDUSTRIAL INNOVATION: FROM KNOWLEDGE TO THE MARKET 

Due  to  the  enabling  character  of  N&N,  advances  can  be  made  in  virtually  all 
technology sectors. European industry, R&D organisations, universities and financial 
institutions  should  work  together  to  ensure  that  excellence  in  N&N  R&D  is 
translated into commercially viable, inherently safe products and processes.  

Standards  provide  a  level  playing  field  for  markets  and  international  trade  and  are 
prerequisites  for  fair  competition,  comparative  risk  assessments  and  regulatory 
measures.  The  protection  of  intellectual  property  rights  (IPR)  is  essential  for 
innovation  both  in  terms  of  attracting  initial  investment  and  for  ensuring  future 
revenue. 

4.1  The Commission will:  

a) 
Foster  the  industrial  exploitation  of  R&D  N&N  by  bringing  together 
stakeholders  to  exchange  best  practice  for  the  commercialisation  of  N&N.  Special 
attention  will  be  paid  to  the  societal,  political  and  psychological  barriers  to 
entrepreneurship  in  Europe  e.g.  the  stigma  of  failure,  as  well  as  how  to  better 
facilitate  agreement  upon  licensing  arrangements  between  industry  and  R&D 
organisations / universities e.g. the ‘Berliner Vertrag’ or the Responsible Partnering 
Initiative; 

Increase  the  industrial  involvement  in  collaborative  EU  R&D  projects  for 
b) 
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; 

c) 
Support  the  creation  of  a  web-based  ‘Digital  N&N  Library’  to  analyse  the 
diverse landscape of N&N in Europe and to draw together data from a wide range of 
sources  e.g.  publications,  patents,  companies,  market  data,  R&D  projects, 
organisations; 

d) 
Support  pre-normative  R&D  for  N&N  in  synergy  with  the  activities  of 
European Standards Bodies. It will in particular invite proposals for Specific Support 
Actions for ‘nanometrology’ in FP6; 

e) 
Support  the  establishment  of  a  N&N  Patent  Monitoring  System  e.g.  by  the 
European  Patent  Office  (EPO)  as  well  as  the  harmonisation  of  practices  in  the 
processing  of  N&N  patent  applications  between  patent  offices  such  as  the  EPO, 
United States Patent and Trademark Office (USPTO) and Japan Patent Office (JPO). 

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4.2  The Commission calls upon the Member States: 

a) 
To put in place measures and incentives for innovation in N&N, also building 
upon Commission initiatives to investigate the use of public demand (procurement) 
to promote the uptake of innovation by private companies. SMEs and ‘start ups’ and 
regional technological clusters integrating industry, R&D organisations / universities, 
investors and other stakeholders can play a crucial role in particular at regional level. 
The  new  ‘Regions  of  Knowledge’  initiative  could  contribute  towards  establishing 
involvement  of  business  ‘angels’  or 
effective  clusters  and  networks.  The 
management  specialists  into  N&N  ‘start  up’  companies  can  help  for  improving  in-
house competencies; 

To  boost  and  coordinate  activities  in  standardisation  for  N&N  and  welcomes 
b) 
the  creation  of  a  working  group  by  the  European  Committee  for  Standardisation 
(CEN)14; 

To  reach  agreement  as  soon  as  possible  on  the  adoption  of  the  Community 
c) 
patent,  noting  that  patenting  of  N&N  inventions  in  Europe  develops  slowly 
compared  to  other  world  regions,  and  to  take  into  due  account  the  importance  of 
globally  harmonising  the  treatment  of  N&N  patent  applications  with  a  view  to  a 
more efficient global patenting system15; 

d) 
To  support  technology  transfer  in  N&N  by  taking  advantage  of  the  pan-
European  Innovation  Relay  Centre  (IRC)  network16  which  aims  at  facilitating 
transnational technology transfer in Europe and promoting innovation at local level. 

5. 

INTEGRATING  THE  SOCIETAL  DIMENSION:  ADDRESSING  EXPECTATIONS  AND 
CONCERNS 

While  N&N  is  bringing  about  important  advances  and  benefits  for  our  society  that 
improve  our  quality  of  life,  some  risk  is  inherent,  as  for  any  technology,  and  this 
should be openly acknowledged and investigated upfront. 

An  essential  element  of  this  responsible  strategy  for  N&N  is  to  integrate  health, 
safety  and  environmental  aspects  to  the  technological  development  of  N&N  and  to 
establish  an  effective  dialogue  with  all  stakeholders,  informing  about  progress  and 
expected benefits, and taking into account expectations and concerns (both real and 
perceived) so to steer developments on a path that avoids negative societal impact. 

The Commission wishes to encourage the development of a society where the public, 
scientists, industry, financial operators and policy makers feel comfortable in dealing 
with  issues  associated  with  N&N.  Due  to  the  nature  of  N&N,  societal  issues  may 
arise  and  should  be  anticipated  e.g.  for  less  skilled  labour,  as  regards  the  risk  of  a 
disequilibria amongst different EU regions and as regards ensuring affordable access 
to the benefits of N&N e.g. in nanomedicine. 

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CEN Resolution BT C005/2004 http://www.cenorm.be 
Science,  Technology  and  Innovation  for  the  21st  Century  OECD  Committee  for  Scientific  and 
Technological Policy at Ministerial Level 29-30 January 2004 
http://irc.cordis.lu 

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5.1  The Commission will: 

a) 
Ensure that Community funded R&D in N&N continues to be carried out in a 
responsible  manner  e.g.  via  the  use  of  ethical  reviews.  Possible  ethical  issues  for 
N&N  include  e.g.  non-therapeutic  human  enhancement,  invasion  of  privacy  due  to 
invisible sensors. The integration of ethical concerns, innovation research and social 
sciences into N&N R&D will help build confidence in decision-making related to the 
governance of N&N17; 

b)  Ask the European Group on Ethics in Science and New Technologies to carry 
out  an  ethical  analysis  of  nanomedicine.  This  will  identify  the  primary  ethical 
concerns  and  enable  future  ethical  reviews  of  proposed  N&N  R&D  projects  to  be 
carried out appropriately; 

c) 
Support  studies  and  foresight  activities  into  future  N&N  scenarios  so  to 
provide  useful  information  about  the  possible  risks  to,  and  potential  impact  on, 
society.  In  the  area  of  nanobiotechnology,  synergy  can  be  developed  with  a  study 
that  is  being  undertaken  by  the  Commission  at  the  request  of  the  European 
Parliament to assess and conduct a cost-benefit analysis of biotechnology and genetic 
engineering; 

d) 
Create  the  conditions  for  and  pursue  a  true  dialogue  with  the  stakeholders 
concerning  N&N.  In  support  of  this  dialogue,  special  Eurobarometer  (EB)  surveys 
should  study  the  awareness  of  and  attitudes  towards  N&N  across  Member  States. 
This  will  allow  an  assessment  of  the  effectiveness  of  different  approaches  across 
Europe as well as providing ‘early warning’ of particular concerns; 

Produce  multilingual  information  material  to  raise  awareness  of  N&N  for 
e) 
different  age  groups  building  upon  the  success  of  pilot  initiatives  that  have  been 
launched  by  the  Commission  including  films18,  brochures  and  other  internet-based 
material19; 

5.2  The Commission calls upon the Member States:  

To  further  develop  a  regular  dialogue  on  N&N  at  appropriate  level  with  the 

a) 
public, in particular via the media; 

b) 

To foster consumer education in application fields enabled by N&N; 

c) 
To  encourage  industry  to  take  into  account  the  wider  economic,  societal, 
health, safety and environmental impacts of their commercial activities in N&N e.g. 
according to the concepts of Corporate Social Responsibility and ‘triple bottom line’ 
reporting as with the Global Reporting Initiative. 

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http://europa.eu.int/comm/mediatheque/video/index_en.html 
http://www.cordis.lu/nanotechnology  

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6. 

PUBLIC HEALTH, SAFETY, ENVIRONMENTAL AND CONSUMER PROTECTION 

All applications and use of N&N must comply with the high level of public health, 
safety,  consumers  and  workers  protection,  and  environmental  protection  chosen  by 
the Community20. The presence of N&N-based products on the market is expected to 
increase rapidly, including via less controlled internet commerce. 

Nanoparticles exist in nature or can be produced by human activities, intentionally or 
unintentionally.  Taking  into  account  that  smaller  particles  have  a  greater  (re)active 
surface area per unit mass than larger particles, toxicity and potential health effects 
may  also  increase21.  There  is  therefore  concern  about  the  potential  impact  of 
nanoparticles on human health and the environment. 

Risk  assessment  related  to  human  health,  the  environment,  consumer  and  workers 
should  be  responsibly  integrated  at  all  stages  of  the  life  cycle  of  the  technology, 
starting at the point of conception and including R&D, manufacturing, distribution, 
use and disposal or recycling. Appropriate ex ante assessments should be carried out 
and risk management procedures elaborated before e.g.  commencing with the  mass 
production  of  engineered  nanomaterials.  Particular  attention  should  be  paid  to 
products that are already or close to being on the market such as household products, 
cosmetics, pesticides, food contact materials, and medical products and devices. 

The European Environment and Health Action Plan 2004-201022 and the Community 
Strategy on Health and Safety at Work23 provide basis for future possible initiatives. 
The  Commission  proposal  on  REACH24  may  cover  some  aspects  on  nanoparticles 
produced in very high quantities. Until REACH is adopted, the notification scheme 
under  Directive  67/548/EEC  will  apply  for  new  substances  and  notified  substances 
with significantly new uses. 

6.1  The Commission will: 

a) 
Identify  and  address  safety  concerns  associated  with  applications  and  use  of 
N&N  at  the  earliest  possible  stage.  The  Scientific  Committee  on  Emerging  and 
Newly  Identified  Health  Risks  has  been  requested  to  provide  an  opinion  on  the 
appropriateness  of  existing  methodologies  to  assess  the  potential  risks  associated 
with engineered and adventitious products of N&N; 

b) 
Promote  safe  and  cost-effective  measures  to  minimise  exposure  of  workers, 
consumers  and  the  environment  to  manufactured  nano-scale  entities.  It  will  also 
support  a  wide  range  of  studies  (including  epidemiological  studies)  to  (i)  evaluate 
current and future projected levels of exposure, (ii) evaluate the adequacy of current 
approaches  to  control  exposure  and  (iii)  launch  appropriate  initiatives,  propose 
measures and/or issue recommendations; 

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24 

See Treaty Articles 152 (health), 153 (consumers), and 174 (environment) 
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” 
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Registration,  Evaluation  and  Authorisation  of  Chemicals  http://europa.eu.int/comm/environment/che 
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c)  Develop  with Member States,  international organisations, European agencies, 
industry  and  other  stakeholders,  terminology,  guidelines,  models  and  standards  for 
risk  assessment  throughout  the  whole  life-cycle  of  N&N  products.  Where 
appropriate,  risk  assessment  and  management  procedures  will  need  to  be  adapted 
accordingly to ensure a high level of protection; 

d) 
Examine  and,  where  appropriate,  propose  adaptations  of  EU  regulations  in 
relevant sectors in light of the above paying particular, but not exclusive, 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. 

6.2  The Commission calls upon the Member States: 

To make inventories of use and exposures of N&N applications, in particular, 

a) 
manufactured nano-scale entities; 

Review  and,  where  appropriate,  modify  national  legislation  to  take  into 

b) 
account the specificities of N&N applications and use; 

Take  nanoparticles  into  account  in  the  enforcement  of  the  new  substances 

c) 
notification scheme under Directive 67/548/EEC; 

Support  the  adoption  of  universally  recognised  Chemicals  Abstract  Service 

d) 
registry numbers and Material Safety Data Sheets for nanomaterials. 

7. 

INTERNATIONAL COOPERATION 

International  cooperation  in  N&N  is  needed  both  with  countries  that  are 
economically and industrially advanced (to share knowledge and profit from critical 
mass) and with those less advanced (to secure their access to knowledge and avoid 
any  ‘nano  divide’  or  knowledge  apartheid).  Particular  attention  will  be  paid  to 
cooperation  with  countries  covered  by  the  European  Neighbourhood  Policy  and 
those with existing S&T cooperation agreements. 

In  compliance  with  its  international  obligations  and  notably  those  relating  to 

7.1 
the World Trade Organisation, the Commission will:  

a) 
Intensify dialogue at international level with a view to adopting a declaration 
or  a  ‘code  of  good  conduct’  for  the  responsible  development  and  use  of  N&N. 
Industry shall be invited to adhere to these principles; 

b)  Address  issues  of  mutual  benefit  at  global  level  e.g.  on  nomenclature, 
metrology,  common  approaches  to  risk  assessment  and  the  establishment  of  a 
toxicological  and  ecotoxicological  as  well  as 
dedicated  database 
epidemiological data; 

to  share 

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c) 
Support the creation of a free and open European electronic archive of N&N 
scientific and technical publications according to the principles set out in the OECD 
Declaration on Access to Research Data from Public Funding25. 

7.2  The Commission calls upon the Member States: 

To  increase  their  support  for  N&N  R&D  and  capacity  building  in  less  developed 
countries.  It  highlights  the  potential  of  N&N  to  contribute  towards  the  Millennium 
Development Goals26 and sustainable development e.g. as regards water purification, 
providing high quality and safe nutrition, more effective delivery of vaccines, lower 
cost health screening, more efficient conservation and use of energy. 

8. 

IMPLEMENTING A COHERENT AND VISIBLE STRATEGY AT EUROPEAN-LEVEL 

An  integrated  strategy  cannot  be  implemented  in  a  linear  fashion  but  it  requires 
coherent and coordinated action. In addition, given the increasing interest of citizens 
in  the  implications  of  N&N,  it  is  important  that  action  at  EU-level  is  given 
appropriate visibility and is effectively communicated. 

In  response  to  the  calls  from  the  Council  for  a  coordinated  management  of  N&N 
initiatives  at  European  level27,  the  Commission  will  establish  a  focal  point  for 
coordination at EU level for: 

a)  Monitoring  and  overseeing  the  implementation  of  this  Action  Plan,  its 
conformity  and  coherence  with  Commission  policies  (e.g.  R&D,  education  and 
training,  employment,  enterprise  policies,  health  and  consumer  protection),  related 
initiatives throughout the Union and other relevant activities (e.g. the Commission’s 
Biotechnology Steering Committee), so to ensure maximum effectiveness; 

b) 
Reporting  on  progress  made  with  the  Action  Plan  every  two  years  to  the 
Council  and  the  European  Parliament,  making  use  of  indicators,  where  possible.  A 
revision of the Action Plan, if necessary, shall be envisaged; 

Performing  a  range  of  activities  so  to  accompany  and  foster  a  useful, 
c) 
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. 

25 

26 

27 

Science,  Technology  and  Innovation  for  the  21st  Century  OECD  Committee  for  Scientific  and 
Technological Policy at Ministerial Level 29-30 January 2004 
Innovation:  Applying  Knowledge  in  Development.  UN  Millennium  Project  2005,  Task  Force  on 
Science, Technology, and Innovation 
Conclusions of the Competitiveness Council 24 September 2004 

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