EN Official Journal of the European Union C 218/21

Opinion of the European Economic and Social Committee on the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee. Regulatory aspects of nanomaterials

COM(2008) 366 final

2009/C 218/04

On 17 June 2008 the Commission decided to consult the European Economic and Social Committee, under Article 262 of the Treaty establishing the European Community, on the

‘Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee. Regulatory aspects of nanomaterials’

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee’s work on the subject, adopted its opinion on 3 February 2009. The rapporteur was Mr PEZZINI.

At its 451st plenary session, held on 25-26 February 2009 (meeting of 25 February 2009), the European Economic and Social Committee adopted the following opinion by 170 votes to one with four abstentions.

1. Conclusions and recommendations

1.1 The EESC believes that Europe is spearheading responsible development of nanoscience and nanomaterials (N&N), thus contributing to worldwide economic and social progress.

1.2 The EESC stresses the need for rapid development of industrial and cross-sectoral applications for nanotechnologies, whilst keeping firmly in mind: — the economic and social context; — the legal, tax and financial aspects; — the care that needs to be taken of the ethical, environmental, health and safety aspects throughout the lifecycle of scientific applications.

1.3 The EESC supports the principles set out in the code of conduct on nanotechnologies and considers them also to be valid for the revision of the European legal and regulatory framework for N&N.

1.4 The EESC is concerned by the rate of progress, which is still too slow, in market applications for nanotechnologies and research into the environmental, health and toxicological effects of nanomaterials.

1.5 The EESC is convinced that the complexity and rapid development of nanotechnologies, and the fact that they involve a wide range of scientific disciplines, call for a multi-disciplinary approach, especially as regards risk, within a regulatory, ethical and social framework. This is essential to providing consensual solutions for risk management, based on a reliable, complete and responsible foundation.

1.6 An optimal system of governance must keep a balance between the various aspects of the responsible development of nanomaterials. The EESC recommends that the European Observatory on Nanotechnologies be made permanent, so that it can provide analyses on sound scientific and economic bases and can examine the impact on society and the possible risks to the environment, health and safety (EHS), in cooperation with the other relevant European agencies.

1.7 The EESC believes that an integrated regulatory frame of reference is needed, as well as a system of governance, with the aim of providing clear and reliable answers to the emerging needs, particularly as regards common classification methods, metrology and testing, validation of existing protocols, new protocols, and pre-normative and co-normative research.

1.8 The EESC believes that robust action is needed in the area of interdisciplinary education and training and that this should include risk evaluation and prevention, backed up by infrastructures of excellence.

1.9 The EESC considers it important to develop a European system of benchmarking for the initiatives that are being developed in the area of risk assessment and prevention, in Europe, in the USA, in Japan and in the emerging economies.

1.10 The EESC believes that the work on technical and regulatory standardisation that is being carried out by CEN, CENELEC and ETSI should be supported, including through clear and transparent mandates from the Commission, with a view to feeding this in to the work of ISO/TC 229 at international level, thus facilitating safe world trade in nanotechnologies, nanomaterials and more complex systems involving N&N.

1.11 The EESC recommends that structured dialogue with civil society be strengthened, on a sound and transparent basis, to provide a united European voice in this field, which is vital to our future on the global stage.

1.12 The EESC asks that, in the 2009 report on the Action Plan, a chapter be expressly dedicated to: — progress in the regulatory framework, including assessment and prevention of risks; — efficacy and results of test protocols; — new priorities for action, set at European and Member State level, for the sustainable production, trade and consumption of products made with nanotechnological components; — benchmarking measures with the USA, Japan and emerging countries on risk assessment and prevention; — structured dialogue with civil society, on a sound and transparent basis, to provide a united European voice in this field, which is vital to our future on the global stage.

2. Introduction

2.1 In recent years, the Commission has become the largest public funding body for N&N: it spent EUR 1.4 billion under the Sixth Framework Programme for RTD (FP6) and almost EUR 600 million in the first year of FP7 2007-2013. EUR 28 million of this latter amount were allocated to research on the safety of N&N, bringing the total allocated to that area to around EUR 80 million (1).

2.2 Various European technological platforms have been set up, dedicated to nanotechnological applications, such as that on nanoelectronics (ENIAC), that on nanomedicine and that on sustainable chemicals.

2.3 Worldwide public and private spending on N&N reached EUR 24 billion during the period 2004-2006. More than a quarter of this came from Europe; of this, 5-6 % (2) is represented by Commission funding.

2.4 The provisions under RTD FP7 2007-2013 (3) relating to N&N require respect for fundamental ethical principles, as set out in the Charter of Fundamental Rights.

2.5 The report on the Third International Dialogue for responsible R&D in nanotechnologies highlighted the efforts made on: — governance in nanotechnologies; — gaps in North-South cooperation; — enabling instruments (metrology, standardisation, definitions and intellectual property); — involving society; — dialogue with the public in various countries.

2.6 The commitment of various international organisations has also been demonstrated, inter alia through the following initiatives: — OECD Database on Human Health and Environmental Safety Research, and the launch of a Database of Research into the Safety of Manufactured Nanomaterials; — Joint FAO/WHO Food Standards Programme, aimed at providing a neutral international forum for food safety problems relating to nanotechnologies and drawing up cooperation agreements on these matters; — OECD projects on Safety Testing of a Representative Set of Manufactured Nanomaterials and on Manufactured Nanomaterials and Test Guidelines; — OECD project on Exposure Measurement and Exposure Mitigation; — OECD project on The role of Alternative Methods in Nanotoxicology; — OECD project on Impacts and the Business Environment — OECD project on Communication and public engagement; — OECD project on Global Challenges: Nano and Water; — OECD project on Cooperation on Risk Assessment; — specialised centres working together with the WHO on studying the risks to health and safety at work arising from the production and use of nanotechnologies; — WHO/EU project on Enhanced Policy Advice on Environment and Health in Europe – Nanotechnologies; — worldwide measures for the proper management of chemical products at global level, promoted by the Chemical Products section of the United Nations Environment Programme (UNEP)’s Division of Technology, Industry and Economics (DTIE); — immediate measures promoted by the High Technology and New Materials section of the International Centre for Science and High Technology (ICS) in Trieste (in the area of evaluating nanotechnologies and the potential risks associated with their development and use); — ISO TC229 standards for nanotechnology; — UNIDO meeting of experts (December 2007): recommendations and specific action plan; evaluation of nanotechnologies and associated risks. Research into the ethical, legal and societal aspects of N&N.

2.7 The Royal Society’s report on Nanosciences and Nanotechnology: Opportunities and Uncertainties (4) states: ‘Until more is known about environmental impacts of nanoparticles and nanotubes, we recommend that the release of manufactured nanoparticles and nanotubes into the environment be avoided as far as possible’.

2.8 Nanomaterials are already present in many everyday objects (5): self-cleaning coatings, which limit the use of detergents; depolluting agents for removing nitrogen oxides from the air; new-generation photovoltaic cells; heat insulating materials; CO2 capture systems; nanofilters for air and water, as well as the many applications in medical diagnostics and certain non-invasive therapies.

2.9 The problem also arises from the need to adapt the protocols for assessing short and long term toxicity risks to nanomaterials and to the phenomena of their accumulation and combination with other substances in ecosystems, organic tissues and people.

2.10 Standards for and verification of the evaluation of risks in complex environments may vary between in vitro and in situ assessments: the research in this area (6) should go beyond conventional protective products, such as filters, breathing masks, protective clothing, and gloves – these articles having been tested with graphite nanoparticles of between 10 and 50 nanometres in length.

2.11 As the Commission points out – and as the EESC has often stressed – ‘the “integrated, safe and responsible approach” has become the core of the EU policy for nanotechnology’. The scope of the applications and ramifications of such technologies is very wide, necessitating a broad overview to identify and make use of the overlaps and interdependencies in this discipline, which ranges from nuclear physics to plasma technology, from nanomechanics to textile production.

2.12 Given that nanoprocesses take place in nanoscopic dimensions (10–9), which are hard for the uninitiated to imagine, nanomaterials require, from the outset, constructive dialogue with consumers so as to identify and avoid dangers and to allay any unfounded fears that may arise.

2.13 The EESC has already highlighted the need not only for ‘speeding up the development of industrial and multi-sectoral applications and the economic, social, legal, regulatory, fiscal and financial context into which the work of innovative new businesses and professional profiles must fit’, but also ‘to safeguard ethical, environmental, health and safety interests throughout the lifecycle of scientific applications’ (7).

2.14 In a more recent opinion (8), the EESC reiterated the need for ‘a visible, transparent dialogue with civil society, ensuring awareness based on objective evaluations of the risks and opportunities presented by N&N’ and ‘constant vigilance to protect ethical and environmental aspects, together with the health and safety of workers and consumers’.

2.15 In 2008, the Commission adopted a recommendation (9) focused on responsible N&N research. The recommendation proposed a code of conduct based on seven principles: — 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, dissemination and use; — sustainability: N&N research activities should be safe, ethical and contribute to sustainable development and should not harm people, animals, plants or the environment; — precaution: activities should be conducted in accordance with the precautionary principle (10) so as to avoid any negative environmental, health and safety impact; — inclusiveness: transparency and respect for the legitimate right of access to information, and openness to all stakeholders; — excellence: applying the best scientific standards, including standards underpinning the integrity of research and standards relating to Good Laboratory Practices (11); — innovation: governance of N&N research activities should encourage maximum creativity, flexibility and planning ability for innovation and growth; — 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. The recommendation provides for an annual report from the Member States on the results of implementing the code of practice and on any good practices put in place to achieve those results.

2.16 The EESC supports the principles of that code and considers them to be valid also for the revision of the European legal and regulatory framework for N&N.

2.17 The EESC is concerned by the excessively slow progress made in market applications for nanotechnologies and research into the environmental, health and toxicological effects of nanomaterials.

2.18 Whilst, as things currently stand, the level of risk associated with the exposure of workers and the public still appears to be limited, the EESC considers it essential to strengthen the channels of dialogue with the world of research and industry so that these aspects are included – with appropriate human and financial resources – in all research and applications involving nanomaterials, from the design phase on.

2.19 The EESC points out that, just as there are many disciplines and many sectors involved, there is a similarly large number of relevant Community legislative and regulatory instruments (more than 90). The transparency of Community legislation and its ease of understanding by the public may be undermined by its complexity.

2.20 The regulatory framework could be made easier to understand, in particular for SMEs, consumers and the public, through efforts to translate legislation into simple language, the development of a dedicated interactive website, participatory democracy involving civil society organisations, and the dissemination of best practice guidelines.

2.21 An optimal governance system needs to be able to maintain equilibrium between the various aspects of responsible development of nanomaterials. The EESC recommends that a permanent reference structure be developed, perhaps on the basis of the results of the Observatory on Nanotechnologies, which was launched in 2008 as a project financed by the EU (12): the aim is to provide reliable analyses on sound scientific and economic bases, to look at ethical issues, to foresee possible risks to the environment, health and safety (EHS), and to develop new standards.

2.22 The EESC is convinced that the complexity and rapid development of nanotechnologies, and the fact that they involve a wide range of scientific disciplines, call for a multi-disciplinary (regulatory, ethical and social) approach: this is essential if it is to be possible to provide, in terms of risk management, reliable solutions based on dependable, complete and responsible analyses that accurately collate, record and publish comprehensive information on engineered nanomaterials.

3. The Commission proposals

3.1 The Commission proposes, in particular: — reviewing documents that support implementation, particularly in relation to risk assessment, adopted within the context of current legislation in order to ensure that they effectively address risks associated with nanomaterials and make best use of the information becoming available; — asking authorities and agencies to pay special attention to risks in relation to nanomaterials where production and marketing are subject to pre-market control; — applying to N&N research in the EU the guidelines for a responsible and open approach set out in the code of conduct for responsible research; — examining the possibility of making the placing on the market of devices presenting risks associated with nanomaterials subject to a systematic pre-market intervention; — improving the Community legislative framework covering nanomaterials, especially as regards test methods and risk assessment methods; — rapidly improving the scientific knowledge base, particularly as regards data on toxic and eco-toxic effects as well as test methods to generate such data; data on uses and exposures throughout the lifecycle of nanomaterials or products containing nanomaterials; characterisation of nanomaterials; the development of uniform standards and nomenclature and analytical measurement techniques; and occupational health aspects; — strengthening the possibilities of using instruments at national level: safeguard clauses, health monitoring measures, and food, feed and pesticide market controls; formal objections to standards; precautionary measures or measures based on new evidence or re-assessment of existing data; vigilance procedures and mutual exchange of information; alert/early warning systems, etc.

4. General comments

4.1 Europe is spearheading responsible development of N&N and nanomaterials, thus contributing to economic and social progress in a challenging, competitive worldwide environment. If it is to continue doing so, the EESC believes that this process needs from the outset to be handled using a multi-disciplinary approach that enables ongoing dialogue with civil society, which is a prerequisite for its public acceptance.

4.2 Whilst appreciating the Commission’s efforts to analyse the large number of existing Community measures, the EESC believes that this analysis needs to be developed further into a coherent framework to provide the transparent and user-friendly basis needed to carry out structured dialogue with civil society. The EESC has called for such dialogue on several occasions (13).

4.3 The EESC believes that foresight for nanotechnological risk-assessment should be developed, along with an integrated regulatory frame of reference and a joined-up system of governance at international level, to give clear, reliable, complete answers and examine the ethical impact, the possible risks for the environment and public health and safety, and possible developments in these areas.

4.4 The EESC therefore asks that the Community initiative be further developed so as to: — ensure that there is a coherent and user-friendly framework into which the various Community regulations fit; — identify and address the emerging needs of market operators, supervisory authorities, workers in the sector and end users, through dynamic mapping of needs and gaps and setting out what action is needed at EU and Member State level to address these; — set up a permanent European reference structure for N&N and nanomaterials, with a European focal point for promotion and coordination (14) that also covers the risk assessment and prevention aspects; — strengthen interdisciplinary education and training measures, including risk assessment and prevention, and European centres of excellence in this area; — develop a European system of benchmarking for initiatives in the area of risk assessment and prevention, in Europe, in the USA, in Japan and in the emerging economies; — bolster the standards of European leadership in sustainable and safe nanotechnology applications, in terms of metrology and testing and validation of existing protocols, inter alia by making use of pre-normative and co-normative research; — support the harmonisation of European technical standards, with clear and transparent mandates, with a view to feeding this in to the work of ISO/TC 229 at international level, thus facilitating world trade; — facilitate structured dialogue with civil society, on a sound and transparent basis, to provide a united European voice in this field, which is vital to our future on the global stage.

4.5 The EESC asks that, in the 2009 report provided for in the 2005-2009 action plan, a chapter be dedicated to the progress made on the regulatory aspects of risk assessment and prevention, the efficacy of test protocols and advances made thereon, and on the new priorities for action.

Brussels, 25 February 2009. The President of the European Economic and Social Committee Mario SEPI

(1) See Tomellini, R; Giordani, J. (eds.). Third International Dialogue on Responsible Research and Development of Nanotechnology – Brussels, 11.-12.3.2008.

(2) See COM(2007) 505 final, 6.9.2007: Nanosciences and Nanotechnologies: An action plan for Europe 2005-2009. First Implementation Report 2005-2007.

(3) See Council Decision 2006/971/EC, 19 December 2006 (OJ L 400, 30.12.2006).

(4) The Royal Society. Nanosciences and Nanotechnology: Opportunities and Uncertainties. London, 29.7.2004.

(5) Such as tennis racquets, bicycles, TV screens, many resins used in military hardware, aerospace, consumer electronics, and electro-medical equipment.

(6) See NANOSAFE2 project – first report on the dissemination of nanomaterials based on the precautionary principle.

(7) See OJ C 157, 28.6.2005, p. 22.

(8) See OJ C 185, 8.8.2006, p. 1.

(9) See Commission Recommendation, C(2008) 424, 7.2.2008.

(10) See Article 174 (2) TEU and the Communication from the Commission on the precautionary principle (COM(2000) 1 final).

(11) See Directive 2004/9/EC and Directive 2004/10/EC.

(12) See ‘Observatory nano’ FP7 PROJECT.

(13) See footnotes 6 and 7.

(14) See OJ C 185, 8.8.2006, p. 1.