landmark re p o r t
otechnology in consumer products:
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challenges and opportunities for Europe
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Table of Contents List of boxes, tables and figures .......................................................................................................... 6 EXECUTIVE SUMMARY ........................................................................................................... 7 1. THE CHALLENGE FOR EUROPE ......................................................................................... 12 What is nanotechnology? ................................................................................................................12 Applications of nanosciences and nanotechnologies .....................................................................14 Key drivers .......................................................................................................................................16 Consumer acceptance and trust .......................................................................................................16 Science and innovation ..................................................................................................................... 17 Regulatory framework ......................................................................................................................18 International developments and cooperation ...................................................................................19 Key challenges for Europe ..............................................................................................................19 Structural weaknesses in RDI ........................................................................................................... 20 Failure to convert knowledge into commercial applications ............................................................. 20 Under-investment in RDI in Europe ................................................................................................. 22 The challenge for European business .............................................................................................25 Industry initiatives and programmes ............................................................................................. 27 The social dimension: governance, ethics and public engagement .............................................. 31 Key Issues.......................................................................................................................................... 31 Public attitudes to nanotechnology ...............................................................................................36 Landmark stakeholder survey ........................................................................................................38 2. THE EU’S APPROACH TO NANOTECHNOLOGY ................................................................. 42 Towards a European strategy for nanotechnology .......................................................................43 From strategy to action: EU Nanotechnology Action Plan 2005-2009 .........................................45 Flanking measures: reinforcing the EU’s RDI framework ............................................................. 47 Strengthening Europe’s RDI Infrastructure ...................................................................................... 47 Promoting industry innovation ....................................................................................................... 48 Measures to boost investment .........................................................................................................50 Promoting and improving intellectual and industrial property rights ............................................... 51 EU R&D Policy and projects for nanotechnologies ....................................................................... 53 The 7th RTD Framework Programme (FP7) and nanotechnology ................................................ 54 The EU’s approach to ethical and social aspects of nanotechnology ........................................... 57 EU ELSA initiatives for nanotechnology ...................................................................................... 59 Promoting public dialogue, communication and stakeholder engagement ............................... 60 Promoting international cooperation ........................................................................................... 62 3. MANAGING RISK AND BUILDING TRUST .......................................................................... 65 Safety of nanotechnologies: key concerns ....................................................................................66 The EU’s approach to risk assessment ...........................................................................................68 Nanotechnology risk assessment in the EU ...................................................................................69
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Appropriateness of current risk assessment methodologies for nanotechnology and nanomaterials .................................................................................................................................. 71 Risk assessment methodology and technical guidance documents for chemical substances ............ 73 Risk assessment of products of nanotechnologies ............................................................................ 74 Nanotechnology and pharmaceuticals and medical devices ............................................................. 76 Nanotechnology and food and feed ................................................................................................. 77 Nanotechnology and cosmetics .......................................................................................................82 Joint Research Centre and nanotechnologies ...................................................................................84 Stepping up monitoring ..................................................................................................................84 EU Nanotechnology Observatory .....................................................................................................84 Voluntary Reporting Scheme for Engineered Nanoscale Materials ................................................... 85 The international dimension: OECD activities on risk and safety aspects of nanotechnologies ..86 4. THE REGULATORY FRAMEWORK FOR NANOTECHNOLOGY IN EUROPE ........................... 88 Broadening of the EU’s regulatory agenda ...................................................................................89 Wider societal concerns ....................................................................................................................89 The Precautionary Principle ..............................................................................................................89 Regulating nanotechnology: the EU’s incremental approach .......................................................90 Shortcomings of the current EU regulatory regime for nanotechnology ..................................... 93 Towards common definitions, standards and metrology .............................................................. 97 Developing European standards for nanotechnologies ..................................................................... 97 EU work on definitions relating to products of nanotechnologies .....................................................99 Other work on terminology and definitions: ISO and BSI ............................................................... 101 Protecting researchers and workers in the EU ............................................................................. 102 EU rules on worker health and safety ............................................................................................. 102 Criticisms of existing protection of workers from nanomaterials and nanoparticles ...................... 103 European Code of conduct for responsible nanosciences and nanotechnologies............................................................................................................................ 105 5. NANOTECHNOLOGY AND THE REGULATION OF CONSUMER PRODUCTS IN EUROPE ....... 108 Key Horizontal Regulation ............................................................................................................ 108 General Product Safety Directive (GPSD) ....................................................................................... 108 REACH .......................................................................................................................................... 108 Environmental pollution ................................................................................................................. 110 Product-specific regulations and related controls ....................................................................... 111 Cosmetics ....................................................................................................................................... 111 Detergents and household products ............................................................................................... 113 Medical applications ....................................................................................................................... 114 Food ........................................................................................................................................... 115 Novel foods .................................................................................................................................. 116 Food additives .............................................................................................................................. 118 Vitamin and mineral supplements and fortification ...................................................................... 119 Food packaging and contact materials ......................................................................................... 120 RECOMMENDATIONS ....................................................................................................................... 123 References ......................................................................................................................................... 125
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List of Boxes, Tables and Figures Boxes Box 1. Examples of potential areas of nanotechnology-enabled applications and products .................. 14 Box 2. Examples of actual and potential applications ............................................................................ 15 Box 3. Potential risks and challenges facing companies investing in or using nanotechnologies............26 Box 4. Examples of company & industry association codes of conduct for nanotechnology ..................28 Box 5. European focussed nanotechnology industry associations .........................................................29 Box 6. FP7 programme actions .............................................................................................................. 55 Box 7. FP7 focus areas for nanosciences and nanotechnologies............................................................. 56 Box 8. Summary of EFSA's main conclusions on engineered nanomaterials in food and feed ............... 80 Box 9. Code of conduct for responsible N&N research: general principles .......................................... 106
Tables Table 1. EU research and innovation: key challenges, policy objectives and responses ......................... 23 Table 2. Overview of environmental and consumer organisations’ views of nanotechnology ............... 32 Table 3. Landmark nano stakeholder survey: benefits versus risks / occupation of respondent ............. 41 Table 4. Landmark nano stakeholder survey: benefits versus risks / level of knowledge of respondent . 41 Table 5. Key nanotechnology challenges for Europe ............................................................................. 45 Table 6. EU RTD Framework Programme dates and funding ................................................................ 53 Table 7. Examples of nano-related projects under EU Framework RTD Programmes ........................... 54 Table 8. Examples of ELSA nano-related projects under EU RTD Framework Programmes ................. 59 Table 9. Examples of safety-related projects under EU RTD Framework Programmes ......................... 70
Figures Figure 1. Stakeholder awareness of nanotech ....................................................................................... 38 Figure 2. Level of stakeholder concern .................................................................................................. 39 Figure 3. Labelling of nanotech .............................................................................................................40 Figure 4. Benefits versus risks of nanotech ...........................................................................................40
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THE SOCIAL DIMENSION: GOVERNANCE, ETHICS AND PUBLIC ENGAGEMENT Issues of safety, toxicity and environmental impact of nanotechnology, particularly as it is a new and dynamic field, are vitally important and are currently being investigated. They should not, however, marginalise consideration of wider social and ethical issues. The latter issues may in some respects be more challenging since the EU, US and other countries already have tried-andtested risk-assessment and risk-management procedures in place that can be applied (albeit it with appropriate adaptation or adjustment) to many areas of nanotechnologies. The EU’s riskassessment framework is discussed in detail in part 3. While risk assessment is necessarily narrow in focus and highly technical, the social and ethical issues are diverse, often complex and touch upon many aspects of cultural, political and economic beliefs and choices. The overriding focus to date on risk assessment and safety aspects of nanotechnologies and the perceived failure to address adequately wider ethical and societal issues is of concern to some. The Economic and Social Research Council (ESRC) in the UK has carried out extensive reviews of social, ethical and economic aspects of the development of nanosciences and technologies and has warned66 that 'focusing on risk leads to overconcentration on the risks of nano substances to the neglect of wider social risks and uncertainties'. The emphasis on risk is widespread and understandable, not least because eminent reports like that of the UK Royal Society and Royal Academy of Engineering lay emphasis and priority on the need for further study and possible regulation of nanoparticles and potential adverse health, environmental and safety impacts of nanotechnology. At the same time, RS/RAE suggest that it is nanotech applications envisaged in medium (5 to 15 years) and longer (more than 20 years) time scales that are likely to raise significant social and ethical concerns.
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There is consequently a risk of social science becoming a mere bolt-on, downstream consideration of innovation and applications rather than a more fundamental integral part of the whole debate on the development of nanotechnology.
THE KEY ISSUES A number of commentators have identified a broad range of social, economic and ethical issues raised by nanotechnology that need to be addressed. Few of these in reality are specific to nanotechnology as most arise more broadly in respect of many scientific innovations. That said, nanotechnology’s potential scope of application may require them to be considered from a specific perspective of nanotechnology or the precise technology (or its use) envisaged.
“A broad range of social, economic and ethical issues raised by nanotechnology need to be addressed” Concerns of particular commentators and interest groups vary but general categories can be discerned, such as: transparency and public engagement in decision making; effective and adequate consumer and environmental protection regulation; economic issues, including commercialisation; data protection, including IPR and individual privacy; public and consumer communication (including labelling and related issues of an individual’s right to know and to be able to make independent and informed choices); and issues surrounding global governance and equity (such as some NGO concerns over potential concentration of control over nanotechnologies and their potential benefits and rewards resting in the hands of a limited number of global corporations, or the potential impacts on the least developed countries and indigenous communities). These issues are reflected in the positions and demands of many NGO and civil-society groups. The publicly stated views and key concerns of
• likely to buy food products that had been
altered using nanotechnology, though respondents were slightly more positive about products with nanotechnology-enhanced packaging.
LANDMARK STAKEHOLDER SURVEY Public perceptions are influenced by the views of opinion formers and stakeholders that take and communicate a public position on the matter. Stakeholder opinion exerts a particularly strong influence on the way that issues are reported in the media, which in turn both influences and reflects public opinion as a whole. In order to better understand current attitudes of stakeholders in Europe today, Landmark carried out an opinion survey of EU-level stakeholders and opinion formers. The survey yielded a snapshot of the debate in Europe, which is useful to inform stakeholders’ handling of nanotechnology with regard to public policy, as well as to inform emerging trends in the nascent public debate. The online survey was conducted among EUlevel stakeholders who were active in the field of nanotechnology over a three-month period (June -August 2008). We obtained a total of 191 responses from:
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• Industry and trade union representatives • Scientific experts and advisers • European Commission officials and national
civil servants active in the EU • MEPs, MEP assitants and national and
regional policians and representatives active in EU instititutions • Consumer-group and NGO representatives • Journalists
The most interesting findings of the survey were: • Stakeholder awareness of nanotechnology
is relatively high: Sixty-two percent of respondents reported having heard 'a lot' or 'some' about nanotechnology. Only 3 % of respondents claimed to have heard 'nothing at all' about nanotech. (Figure 1) • Actual knowledge of nanotechnology is
modest: Seventy percent of respondents claimed to know little or less than little about nanotech. • Stakeholders display a high level of concern
about nanotechnology: Sixty percent of respondents claimed to have concerns about nanotechnology. Those who have a higher level of knowledge seem to have a higher
Likewise, the Council underlined the need for 'a sustainable and responsible development of nanotechnology, addressing its health, environmental, societal, industrial and economic aspects at the earliest possible stage in order to respond to the justified expectations and concerns of European citizens'. The importance of engaging in dialogue at international level was also noted and Ministers welcomed the Commission's intentions in this respect with a view to establishing a framework of shared principles for the safe, sustainable, responsible and socially acceptable development and use of nanotechnologies. The key challenges Europe faces in respect of nanosciences and nanotechnologies, including those relating to commercialisation, are summarised in Table 5.
FROM STRATEGY TO ACTION: EU NANOTECHNOLOGY ACTION PLAN 2005-2009 Following the Council's endorsement of its strategy and the autumn 2004 public consultation, the Commission tabled in June 2005 a follow-up action plan for the period 20052009. The Action Plan9 sought to turn aspirations into reality. It defined, in the Commission's words, 'a series of articulated and interconnected actions for the immediate implementation of a safe, integrated and responsible strategy for [nanosciences and nanotechnologies]' based on the priority areas identified in the 2004 strategy Communication, namely: RDI; infrastructure and European poles of excellence; interdisciplinary human resources; industrial innovation (i.e. commercialisation); integrating the social dimension; public health, safety, environment and consumer protection; international
Table 5. Key nanotechnology challenges for Europe Research,
development
&
Safety and risk management
Regulatory framework
innovation • Provide a coherent, coordinated EU
•
approach and regulatory framework that supports and encourages scientific endeavour and innovation.
• End fragmentation and dispersion of R&D resources and facilities (poles of excellence, clusters).
•
• Improve coordination of Member State nanotech policies and programmes.
• Stimulate public/private partnerships
•
and collaboration.
• Help overcome Europe's long-standing failure to convert scientific endeavour into wealth- and job-generating products & processes.
•
• Remove regulatory obstacles and cut bureaucracy that delays access/time to market.
• Provide adequate, affordable harmonised protection of inventions that provide adequate IPR protection while not creating unacceptable 'nano monopolies' or 'patent land-grabs'.
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Promote & facilitate exchange of research results and data within EU, extra-EU & between public & private organisations. Support development of common (ideally global) testing and measuring methodologies, definitions and related standards. Ensure on-going review; if necessary, adapt EU risk assessment & management procedures to take account of emerging data and knowledge concerning NPs/MNMs (e.g. new information concerning behaviour of materials at nano scale compared with at macro scale).
•
Encourage & support risk assessment based on lifecycle of NPs/MNMs (both 'free' and 'fixed') to include manufactured, use & disposal.
•
Support & stimulate efforts to build public confidence & trust in nanotech, including effective & appropriate scientific & risk communication, and transparency of risk assessment procedures and decisions.
• Promote international cooperation, in particular to accelerate progress on filling data/knowledge gaps, to agree common definitions, metrology & testing methodologies, and international standards.
Support & stimulate urgent research on areas/aspects to help fill current knowledge 'gaps' (e.g. toxicology, ecotoxicology, exposure metrics etc of NPs/MNMs.)
• Ensure a predictable and proportionate regulatory framework that reflects wider societal goals and ethical considerations.
• Improve implementation and enforcement of regulation, taking account of the specificities of nanotechnologies.
• Stimulate investment in innovative companies and start-ups.
• Avoid potential regulatory confusion by ensuring consistent definitions are used in EU regulations.
• Address public and other stakeholder uncertainties over the extent to which NPs/MNMs are adequately regulated by existing EU rules.
• Distinguish between actual and potential regulatory gaps; modify current legislation, if necessary, in light of new scientific data (e.g. thresholds used in some legislation, specific NPs or MNMs).
• Promote and facilitate open and transparent public engagement and dialogue on nanotechnologies.
4. The Regulatory Framework for Nanotechnology in Europe It is widely recognised that if companies and entrepreneurs are to invest in research, development and innovation in the nanotechnology area in Europe they require an EU regulatory environment and legal framework that facilitates and encourages innovative activities. Such a framework must be predictable, protect intellectual property adequately and provide an open and accessible market for innovative products. Regulations must also be evidence-based and proportionate. At the same time, an effective regulatory regime must reinforce consumer confidence in innovative goods and services by ensuring that effective and appropriate consumer protection is in place. Although there is no nanotechnology-specific regulation in the EU, nanotechnology is not unregulated. For example, among others, general duty of care and product liability rules will apply. Nonetheless, the current uncertainty over the extent to which nanoparticles and nanoenabled products are controlled effectively by existing laws and the absence of a clear, recognisable regulatory regime (be it stand-alone or as part of the broader legislative canon) is unhelpful, particularly for industry; in particular, it feeds public concern and provides a vacuum into which doubt and confusion can spread.
“Better regulation and better research will need to progress in parallel� The negotiation of a future EU regulatory regime for nanomaterials and nano-enabled products will be influenced, like all EU legislative decision making, by a broad range of factors and interests. Some of the key elements that are likely to play a significant role in respect of nanotechnologies are highlighted below. This is followed by a top-line overview of the extent to which the major pieces of existing EU horizontal
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and vertical process- and product-related legislation cover consumer products, highlighting some of the so-called 'regulatory gaps' that have been identified by the Commission and others to date. Many of the gaps identified arise from a lack of adequate data on the potential effects of nanomaterials on human health and the environment. Consequently, effective regulation will depend ultimately on improving risk assessment and availability of data; in effect, better regulation and better research will need to progress in parallel. Such regulatory gaps will inevitably be the focus of political and regulatory attention (and from industry's perspective will present commercial threats and/or opportunities) over the next 12 to 18 months, when some potentially crucial decisions defining the future course of nanotechnologies in Europe will be taken. The European Parliament recently secured an amendment to the draft EU Regulation on food additives to insert a provision requiring that if the production process of an additive is changed, for example via a change in particle size through nanotechnology, a fresh authorisation process including a safety evaluation must be carried out. MEPs are also seeking numerous nanotechnology-related amendments to the EU's draft Cosmetics Directive. This is clear evidence that any updating of the current regulatory regime for consumer products will include discussion and close scrutiny of nanotechnology. Given that several key legislative proposals affecting consumer products are currently or shortly to be under negotiation (among others, the revisions of the Novel Foods Regulation and the Medical Products Directive), the implications for manufacturers of consumer products are clear. The EU's decision-making does not take place in a vacuum and developments in other countries