Legal provisions of C(2008)424 - Code of conduct for responsible nanosciences and nanotechnologies research (notified under document number C(2008) 424)

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30.4.2008   ENOfficial Journal of the European UnionL 116/46



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,

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

Whereas:

(1)In its Communication to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions ‘Towards a European 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).

(2)The Commission adopted in February 2000 a Communication 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.

(3)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.

(4)In 2004, with its Communication ‘Towards a European strategy for nanotechnology’ (4), the Commission identified actions aimed at creating the Community added value necessary to remain competitive in this sector while ensuring its responsible development. In its 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.

(5)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 interconnected 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 acknowledged that environmental, human health and safety aspects need to be integrated in all nanosciences and nanotechnologies research.

(6)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).

(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).

(8)In June 2006 the European Council adopted a revised sustainable development strategy fine-tuning 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.

(9)In its conclusions (9) of 23 November 2007, the Council (Competitiveness) recognised the need to foster synergies and cooperation between all nanosciences and nanotechnologies 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 Nanotechnologies Action Plan for Europe was presented by the Commission in 2007 (10). In this report the Commission announced its intention to adopt a voluntary Code of Conduct for Responsible Nanosciences and Nanotechnologies Research.

(11)This Recommendation includes the Code of Conduct, aiming to promote integrated, safe and responsible 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)This Recommendation provides Member States with an instrument to undertake further initiatives to ensure safe, ethical and sustainable nanosciences and nanotechnologies research in the European Union.

(14)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 for Responsible Nanosciences and Nanotechnologies Research, in the Annex, as they formulate, adopt and implement their strategies for developing sustainable nanosciences and nanotechnologies (hereinafter N&N) research, in line with the Commission Nanotechnologies Strategy and Action Plan.

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

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, monitoring and evaluation processes of public bodies.

4.That Member States encourage the voluntary adoption of the Code of Conduct by relevant national and regional authorities, 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 a supportive research environment, conducive to the safe, ethical and effective development of the N&N potential.

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 application 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, researchers, industry, ethics committees, 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.

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.