Commission Recommendation of 7 February 2008 on a code of conduct for responsible nanosciences and nanotechnologies research (notified under document number C(2008) 424)
Date: 2008-02-07
Institutions: European Commission
Subjects: action programme, code of conduct, ethics, nanotechnology, research and development, research policy

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RECOMMENDATIONS

COMMISSION

COMMISSION RECOMMENDATION

of 7 February 2008

on a code of conduct for responsible nanosciences and nanotechnologies research

(notified under document number C(2008) 424)

(2008/345/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community, and in particular Article 211 thereof,

establishing the European

In 2004, with its Communication ‘Towards a European
strategy for nanotechnology’ (4), the Commission ident-
ified actions aimed at creating the Community added
value necessary to remain competitive in this sector
In its
while
conclusions of 24 September 2004 (5),
the Council
(Competitiveness) welcomed the proposed integrated,
safe and responsible approach and the Commission’s
intention to draw up an Action Plan for nanotechnology.

responsible development.

ensuring its

Whereas:

(1)

(2)

(3)

the European
In its Communication to the Council,
the Economic and Social Committee and
Parliament,
the Regions ‘Towards a European
the Committee of
research area’
the Commission proposed in January
2000 the creation of a European Research Area (1) with
a view to consolidating and structuring European
research policy. In May 2007, in the Green Paper ‘The
European Research Area: New Perspectives’,
the
Commission relaunched a broad institutional and public
debate on what should be done to create a unified and
attractive European Research Area that would fulfil the
needs and expectations of
the scientific community,
business and citizens (2).

The Commission adopted in February 2000 a Com-
munication on the precautionary principle (3), aiming to
build a common understanding of how to assess,
appraise, manage and communicate risks that science is
not yet able to evaluate fully.

In March 2000 the Lisbon European Council set for the
Community the objective of becoming in the next decade
the most competitive and dynamic knowledge economy
in the world, capable of sustainable economic growth
with more and better jobs and greater social cohesion.

(1) COM(2000) 6, 18.1.2000.
(2) COM(2007) 161, 4.4.2007.
(3) COM(2000) 1, 2.2.2000.

(5)

(6)

(7)

Taking into account the results of a public consultation,
the Commission drew up in 2005 a Nanotechnologies
Action Plan (6) which sets out coherent and intercon-
nected actions for the immediate implementation of an
integrated, safe and responsible strategy for nanosciences
and nanotechnologies based on the priority areas
identified in the Communication ‘Towards a European
strategy for nanotechnology’. Both Communications
explicitly
environmental, human
health and safety aspects need to be integrated in all
nanosciences and nanotechnologies research.

acknowledged that

Following the Nanosciences and nanotechnologies Action
Plan, in January 2007 the European Group on Ethics in
Science and New Technologies presented an opinion on
the ethical aspects of nanomedicine (7).

Following comments made during a public consultation
on a previous opinion,
the Scientific Committee on
Emerging and Newly Identified Health Risks adopted in
March 2006 a modified opinion on the appropriateness
of existing methodologies to assess the potential risks
associated with engineered and adventitious products of
nanotechnologies (8).

(4) COM(2004) 338, 12.5.2004.
(5) Doc. 12487/04.
(6) COM(2005) 243, 7.6.2005.
(7) EGE Opinion No 21, 17 January 2007.
(8) SCENIHR/002/05, 10 March 2006.

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(8)

(9)

development

In June 2006 the European Council adopted a revised
sustainable
the
Community sustainable development strategy launched
at the Gothenburg Summit in June 2001 that centred
on objectives of environment and health protection and
poverty eradication.

fine-tuning

strategy

In its conclusions (1) of 23 November 2007, the Council
(Competitiveness) recognised the need to foster synergies
and cooperation between all nanosciences and nano-
technologies stakeholders, including the Member States,
the Commission, academia, research centres,
industry,
financial bodies, non-governmental organisations and
society at large.

(10) A first report on the implementation of

the Nano-
technologies Action Plan for Europe was presented by
the Commission in 2007 (2).
the
Commission announced its
a
voluntary Code of Conduct for Responsible Nanosciences
and Nanotechnologies Research.

intention to adopt

In this

report

(11)

This Recommendation includes the Code of Conduct,
safe and responsible
aiming to promote integrated,
nanosciences and nanotechnologies research in Europe
for the benefit of society as a whole.

(12)

The general principles and guidelines on actions to be
taken outlined in this Recommendation benefited from a
public consultation.

(13)

(14)

This Recommendation provides Member States with an
instrument to undertake further initiatives to ensure safe,
ethical
nano-
technologies research in the European Union.

nanosciences

sustainable

and

and

This Recommendation also aims at contributing to
proper coordination between Member States with a
view to optimise synergies between all nanosciences
and nanotechnologies research stakeholders at European
and international levels,

HEREBY RECOMMENDS:

1. That Member States be guided by the general principles and
guidelines for actions to be taken, set out in the Code of
Conduct
and Nano-
Responsible Nanosciences
for
in the Annex, as they formulate,
technologies Research,
adopt
for developing
sustainable nanosciences and nanotechnologies (hereinafter

and implement

strategies

their

(1) Doc. 14865/07.
(2) COM(2007) 505, 6.9.2007.

research,

N&N)
technologies Strategy and Action Plan.

in line with the Commission Nano-

2. That Member States endeavour to follow these general prin-
ciples and guidelines when implementing their national regu-
latory research and development strategies or developing
sectoral
development
standards, taking into account pre-existing applicable N&N
guidelines, good practices or regulations.

institutional

research

and

and

3. That Member States consider such general principles and
guidelines on research to be an integral part of institutional
quality assurance mechanisms by regarding them as a means
for establishing funding criteria for national/regional funding
schemes, as well as adopting them for the auditing, moni-
toring and evaluation processes of public bodies.

4. That Member States encourage the voluntary adoption of the
Code of Conduct by relevant national and regional auth-
orities, employers and research funding bodies, researchers,
and any individual or civil society organisation involved or
interested in N&N research and endeavour to undertake the
necessary steps to ensure that they contribute to developing
and maintaining
environment,
supportive
conducive to the safe, ethical and effective development of
the N&N potential.

research

a

5. That Member States cooperate with the Commission in order
to review this recommendation every two years, as well as to
monitor the extent
to which relevant stakeholders have
adopted and applied the Code of Conduct.

6. That the criteria for measuring such adherence to and appli-
cation of the Code of Conduct be established and agreed
with the Member States
in relation to similar work
undertaken at Community level.

7. That Member States, in their bilateral agreements on research
strategies and activities with third countries and in their role
as members of international organisations, take due account
of this Recommendation when proposing research strategies
and taking decisions, and duly coordinate with other
Member States and the Commission.

8. That this Recommendation also be used as an instrument to
encourage dialogue at all governance levels among policy
makers,
civil
society organisations and society at large with a view to
increasing understanding and involvement by the general
public in the development of new technologies.

committees,

researchers,

industry,

ethics

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9. That the Member States inform the Commission by 30 June 2008 and annually thereafter of any
measures they have taken further to this Recommendation, inform it of the first results of its application
and provide good practices.

Done at Brussels, 7 February 2008.

For the Commission
Janez POTOČNIK
Member of the Commission

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ANNEX

Code of Conduct for responsible nanosciences and nanotechnologies research

This Code of Conduct provides Member States, employers, research funders, researchers and more generally all individuals
and civil society organisations involved or interested in nanosciences and nanotechnologies (N&N) research (all stake-
holders) with guidelines favouring a responsible and open approach to N&N research in the Community.

The Code of Conduct is complementary to existing regulations. It does not limit or otherwise affect the possibilities of
Member States to grant a wider measure of protection with regard to N&N research than is stipulated in this Code of
Conduct.

Stakeholders who adhere to this Code of Conduct should also be inspired, where applicable, by the principles set out in
the Charter of Fundamental Rights of the European Union.

The Code of Conduct will be regularly monitored and revised every two years by the Commission in order to take into
account developments in N&N worldwide and their integration in European society.

1.

Scope and aim

The Code of Conduct invites all stakeholders to act responsibly and cooperate with each other, in line with the
N&N Strategy and Action Plan of the Commission, in order to ensure that N&N research is undertaken in the
Community in a safe, ethical and effective framework, supporting sustainable economic, social and environmental
development.

The Code of Conduct covers all N&N research activities undertaken in the European Research Area.

The Code of Conduct is voluntary. It offers a set of general principles and guidelines for actions to be taken by all
N&N stakeholders. It should facilitate and underpin the regulatory and non-regulatory approaches outlined in the
2005-09 N&N Action Plan for Europe, improving the implementation of current regulation and coping with
scientific uncertainties.

The Code of Conduct should also be a European basis for dialogue with third countries and international
organisations.

2.

Definitions

For the purpose of the Code of Conduct, the following definitions apply:

(a) Nano-objects: in the absence of recognised international terminology the generic term of ‘nano-object’ is used
throughout the Code of Conduct to designate products resulting from N&N research. It includes nanoparticles
and their
and
nano-products.

aggregation at nanoscale, nano-systems, nano-materials, nano-structured materials

(b) N&N research:

in the broadest sense understood here, N&N research encompasses all research activities
dealing with matter at the nanometric scale (1 to 100 nm). It includes all man-made nano-objects be they
engineered or involuntarily generated. Naturally occurring nano-objects are excluded from the scope of the
Code of Conduct. N&N research encompasses research activities from the most fundamental research to
applied research, technology development and pre- and co-normative research underpinning scientific advice,
standards and regulations.

(c) N&N stakeholders: Member States, employers, research funders, researchers and more generally all individuals

and civil society organisations engaged, involved or interested in N&N research.

(d) Civil society organisations: In the context of the Code of Conduct, civil society organisations are considered to
interests, and

be any legal entity that is non-governmental, not-for-profit, not representing commercial
pursuing a common purpose in the public interest.

3.

General principles

This Code of Conduct is based on a set of general principles which call for actions aimed at guaranteeing their
respect by all stakeholders.

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3.1.

Meaning

N&N research activities should be comprehensible to the public. They should respect fundamental rights and be
conducted in the interest of the well-being of individuals and society in their design, implementation, dissemi-
nation and use.

3.2.

Sustainability

N&N research activities should be safe, ethical and contribute to sustainable development serving the sustain-
ability objectives of the Community as well as contributing to the United Nations’ Millennium Development
Goals (1). They should not harm or create a biological, physical or moral threat to people, animals, plants or the
environment, at present or in the future.

3.3.

Precaution

N&N research activities should be conducted in accordance with the precautionary principle, anticipating
potential environmental, health and safety impacts of N&N outcomes and taking due precautions, proportional
to the level of protection, while encouraging progress for the benefit of society and the environment.

3.4.

Inclusiveness

Governance of N&N research activities should be guided by the principles of openness to all stakeholders,
transparency and respect for the legitimate right of access to information. It should allow the participation in
decision-making processes of all stakeholders involved in or concerned by N&N research activities.

3.5.

Excellence

N&N research activities should meet the best scientific standards, including standards underpinning the integrity
of research and standards relating to Good Laboratory Practices (2).

3.6.

Innovation

Governance of N&N research activities should encourage maximum creativity, flexibility and planning ability for
innovation and growth.

3.7.

Accountability

Researchers and research organisations should remain accountable for the social, environmental and human
health impacts that their N&N research may impose on present and future generations.

4.

Guidelines on actions to be taken

The guidelines set out in this point are based on the set of general principles described in point 3. They are
meant to give guidance on how to achieve good governance, due respect for precaution, as well as wide
dissemination and good monitoring of the Code of Conduct. The main responsibilities for action are indicated
below, but all N&N stakeholders should contribute to their implementation as much as possible within the scope
of their own remit.

4.1.

Good governance of N&N research

Good governance of N&N research should take into account the need and desire of all stakeholders to be aware
of the specific challenges and opportunities raised by N&N. A general culture of responsibility should be created
in view of challenges and opportunities that may be raised in the future and that we cannot at present foresee.

4.1.1. Member States should cooperate with the Commission in order to maintain an open and pluralistic forum for
discussion on N&N research at Community level as a means to stimulate the societal debate about N&N research,
encouraging the identification and discussion of concerns and hopes and facilitating the emergence of possible
initiatives and solutions. Accordingly, Member States should enhance communication on benefits, risks and
uncertainties related to N&N research. Specific attention should be paid to the younger and older members of
the population.

4.1.2. With due respect for intellectual property rights, Member States, N&N research funding bodies, research or-
ganisations and researchers are encouraged to make easily accessible and understandable by lay people as well as
by the scientific community all N&N scientific knowledge as well as related information such as relevant
standards, references, labels, research on impacts, regulations and laws.

(1) The United Nations Millennium Declaration, General Assembly Resolution 55/2, 8.9.2000.
(2) Directive 2004/9/EC and Directive 2004/10/EC.

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4.1.3. Member States should encourage private and public sector laboratories to share best practices in N&N research,

with due respect for the protection of intellectual property.

4.1.4. N&N research organisations and researchers should ensure that scientific data and results are duly peer-reviewed
before being widely disseminated outside the scientific community in order to ensure their clarity and balanced
presentation.

4.1.5. Given its potential, Member States and N&N research organisations should ensure that N&N research is
conducted at the highest level of scientific integrity. Questionable N&N research practices (not limited to
plagiarism, falsification and fabrication of data) should be fought as they may entail risks for health, safety
and the environment, raise public distrust and slow down the dissemination of benefits from research. Individuals
signalling impropriety in research should be protected by their employers and national or regional laws.

4.1.6. Member States should ensure that appropriate human and financial resources are dedicated to the application of
existing laws and regulations applicable to N&N research. Organisations performing N&N research activities
should demonstrate transparently that they comply with relevant regulations.

4.1.7. National and local ethics committees and competent authorities should evaluate the manner of applying ethical
review requirements to dual-use nanotechnology research. They should notably address the fundamental rights
implications of any possible restrictions on informed consent and the publication of research results related to
human health.

Favouring an inclusive approach

4.1.8. The broad directions of N&N research should be decided in an inclusive manner, allowing all stakeholders to

enrich the preliminary discussions on these directions.

4.1.9. Member States, N&N research funding bodies, research organisations and researchers are encouraged to consider,
at the earliest stages and through participatory foresight exercises, the future implications of technologies or
objects being researched. This could allow the development of solutions to meet potential negative impacts
caused by the use of a new object or technology at a later stage. Consultations with relevant ethics committees
should be part of such foresight exercises as appropriate.

4.1.10. N&N research itself should be open to contributions from all stakeholders who should be informed and
supported so that they can take an active part in the research activities, within the scope of their mission and
mandate.

Key priorities

4.1.11. Research authorities and standardisation bodies should endeavour to adopt N&N standard terminology to
facilitate the communication of scientific evidence. They should encourage standard measurement procedures
as well as the use of appropriate reference materials in order to improve comparability of scientific data.

4.1.12. N&N research funding bodies should devote an appropriate part of N&N research to the development of methods
and tools for risk assessment, the refinement of metrology at nano-scale and standardisation activities. In this
context, particular attention should be paid to developing methods to assess the risk of second-generation, active
nano-structures.

4.1.13. Member States, N&N research funding bodies and organisations should encourage fields of N&N research with
the broadest possible positive impact. A priority should be given to research aiming to protect the public and the
environment, consumers or workers and aiming to reduce, refine or replace animal experimentation.

4.1.14. N&N research funding bodies should carry out and publish balanced assessments, based on best available

scientific data, of the potential costs, risks, and benefits of research areas eligible for funding.

Prohibition, restrictions or limitations

4.1.15. N&N research funding bodies should not fund research in areas which could involve the violation of fundamental
rights or fundamental ethical principles, at either the research or development stages (e.g. artificial viruses with
pathogenic potentials).

4.1.16. N&N research organisations should not undertake research aiming for non-therapeutic enhancement of human
beings leading to addiction or solely for the illicit enhancement of the performance of the human body.

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4.1.17. As long as risk assessment studies on long-term safety is not available, research involving deliberate intrusion of
nano-objects into the human body, their inclusion in food (especially in food for babies), feed, toys, cosmetics
and other products that may lead to exposure to humans and the environment, should be avoided.

4.2.

Due respect for precaution

Given the deficit of knowledge of the environmental and health impacts of nano-objects, Member States should
apply the precautionary principle in order to protect not only researchers, who will be the first to be in contact
with nano-objects, but also professionals, consumers, citizens and the environment in the course of N&N research
activities.

4.2.1.

Students, researchers and research organisations involved in N&N research should take specific health, safety and
environmental measures adapted to the particularities of the nano-objects manipulated. Specific guidelines on the
prevention of pathologies induced by nano-objects should be developed in line with the Community Strategy
2007-14 on Health and Safety at Work (1).

4.2.2. N&N research organisations should apply existing good practices in terms of classification and labelling. In
addition, as nano-objects might present specific properties due to their size, they should undertake research
on systems (including e.g. the development of specific pictograms) aiming to inform researchers and more
generally people likely to come into contact with nano-objects in research premises (e.g. security and
emergency staff) so that they may take the necessary and appropriate protection measures in the course of
their duties.

4.2.3.

Public and private N&N research funding bodies should request that a risk assessment be presented along with
each submission of a proposal for funding for N&N research.

4.2.4. N&N research funding bodies’ programmes should include monitoring of the potential social, environmental and

human health impacts of N&N over a relevant period of time.

Application of the precautionary principle should include reducing the gaps in scientific knowledge, and therefore
undertaking further actions in research and development such as the following:

4.2.5. Research funding bodies should devote an appropriate part of N&N research to understanding the potential risks,
notably to the environment and human health, induced by nano-objects, encompassing their whole life cycle,
from their creation up to their end of life, including recycling.

4.2.6. N&N research organisations and researchers should launch and coordinate specific N&N research activities in
order to gain a better understanding of fundamental biological processes involved in the toxicology and eco-
toxicology of nano-objects man-made or naturally occurring. They should widely publicise, when duly validated,
data and findings on their biological effects, be they positive, negative or null.

4.2.7. N&N research funding bodies should launch and coordinate specific research activities in order to gain a better
understanding of ethical, legal and societal impacts of the new fields opened by N&N. Information and com-
munication technologies and biotechnology should receive particular attention as well as the convergence
between these fields and cognitive sciences and N&N.

4.3.

Wide dissemination and monitoring of the Code of Conduct

4.3.1. Member States should support the wide dissemination of this Code of Conduct, notably through national and

regional public research funding bodies.

4.3.2.

In addition to the existence of this Code of Conduct, N&N research funding bodies should make sure that N&N
researchers are aware of all relevant legislation, as well as ethical and social frameworks.

4.3.3. As the application of the Code of Conduct should be monitored across the Community, Member States should
cooperate with the Commission in order to devise adequate measures to carry out such monitoring at national
level and guarantee synergies with other Member States.

(1) COM(2007) 62, 21.2.2007.