1 Arnall, A and Parr, D Moving the nanoscience and technology (Nst) debate forwards: short-term impacts, long-term uncertainty and the social constitution’ (2005) 27(1) Technology in Society 23 CrossRefGoogle Scholar at 23.

2 British Standards Institute Vocabulary – Nanoparticles (PAS 71:2005), p 2; Royal Society and Royal Academy of Engineering (RS/RAEng) Nanoscience and Nanotechnologies: Opportunities and Uncertainties (London: RS, 2004) p 5 Google Scholar;

3 Commission of the European Communities (CEC) Communication Towards a European Strategy for Nanotechnology COM (2004) 338 final, p 4.

4 RS/RAEng, above n 2, p 5.

5 CST, above n 2, p 14.

6 Davies, JC EPA and Nanotechnology: Oversight for the 21st Century (Washington DC: Woodrow Wilson International Center for Scholars, 2007) pp 11–12.Google Scholar

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8 See, eg, Maynard, AD Nanotechnology: assessing the risks’ (2006) 1(2) Nano Today 22 CrossRefGoogle Scholar;

9 See also Frater, L et.al An Overview of the Framework of Current Regulation Affecting the Development and Marketing of Nanomaterials: A Report for the DTI (London: Department of Trade and Industry, 2006 Google Scholar);

10 Calster, GV Regulating nanotechnology in the European Union’ (2006) 3(3) Nanotechnology Law & Business 359 Google Scholar at 360.

11 Bowman, DM and Hodge, GA A small matter of regulation: an international review of nanotechnology regulation’ (2007) 8 Columbia Science and Technology Law Review 1 Google Scholar at 13–20.

12 Frater et.al, above n 9, pp 13–14.

13 Baldwin, R and Cave, M Understanding Regulation: Theory, Strategy, and Practice (Oxford: Oxford University Press, 1999) p 119.Google Scholar

14 Eg Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2006, SI 2006/1463.

15 Eg Plastic Materials and Articles in Contact with Food (England) Regulations 2009, SI 2009/205.

16 Eg Landfill (England and Wales) Regulations 2002, SI 2002/1559; List of Wastes (England) Regulations 2005, SI 2005/895; Urban Waste Water Treatment (England and Wales) Regulations 1994, SI 1994/2841.

17 Braithwaite, J The limits of economism in controlling harmful corporate conduct’ (1982) 16(3) Law and Society Review 481 CrossRefGoogle Scholar at 488.

18 Frater et.al, above n 9, pp 16–17.

19 SCCP Opinion on Safety of Nanomaterials in Cosmetic Products (SCCP/1147/07) p 5, available at http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_123.pdf.

20 Ibid, p 60.

21 Ibid, pp 5–6 and 29–34.

22 Council Directive 76/768/EEC concerning cosmetic products, as amended.

23 SCCNFP Opinion on Titanium Dioxide (SCCNFP/0005/98), available at http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out135_en.pdf.

24 SCCP, above n 19, p 39.

25 Ibid, p 37.

26 Ibid, p 39.

27 European Parliament and Council Regulation (EC) No 1907/2006 concerning REACH, as amended.

28 Before manufacturers and importers handle ‘substances of very high concern’ they must also seek authorisation (Art 55).

29 Formerly, under Council Directive 67/548/EEC (the Dangerous Substances Directive), the lower limit threshold for notification was 10.kg per year.

30 Frater et.al, above n 9, p 84; CST, above n 2, p 30.

31 Health and Safety Executive (HSE) Nanoparticles: An Occupational Hygiene Review (London: HSE, 2004) p 54 Google Scholar; Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) Modified Opinion (after Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks associated with Engineered and Adventitious Products of Nanotechnologies (SCENIHR/002/05) p 55, available at http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf.

32 Note, however, that where a substance is already marketed in bulk form (ie it is not ‘new’), and is subsequently introduced to the market in nano form, its existing registration dossier will have to be updated to include its nano-scale properties (CEC Communication Regulatory Aspects of Nanomaterials COM (2008) 366 final, p 4).

33 RS/RAEng, above n 2, p 71; Government, HM Response to the Royal Society and Royal Academy of Engineering Report (London: HMSO, 2005) p 14.Google Scholar

34 Above n 29.

35 In the process of transferring responsibility for hazardous substances to the European Chemicals Agency, Annex I has been replaced by Annex VI, Table.3.2 of Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging which took effect on 20 January 2009. Since Table-3.2 is based on the former Annex I, the points below continue to apply.

36 HSE, above n 9, p 7.

37 Ibid.

38 Ibid, p 8.

39 Ibid.

40 Cairns Jnr, J Editorial: absence of certainty is not synonymous with absence of risk’ (1999) 107(2) Environmental Health Perspectives 56 Google Scholar at 56.

41 SCENIHR, above n 31, p 34; see also SCENIHR Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance with the Technical Guidance Documents for New and Existing Substances For Assessing the Risks of Nanomaterials (21–22 June 2007), p 35, available at http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_010.pdf.

42 HSE, above n 9, p 8.

43 SCENIHR, above n 41, p 11.

44 It can also have repercussions under other regimes (eg Control of Substances Hazardous to Health Regulations 2002, SI 2002/2677), which rely on information that REACH generates.

45 REACH even imposes a positive obligation on the manufacturers and importers of chemical substances to provide safety data sheets to all the downstream users supplied directly (Art 31).

46 SCENIHR, above n 31, pp 55–56 (emphasis added).

47 SCENIHR, above n 41.

48 CEC, above n 32, p 4.

49 Frater et.al, above n 9.

50 Regulatory responses to nanotechnologies may also be motivated by private, rather than public, interests. I will explore the regulation of nanotechnologies using private interest analysis in further later work.

51 To date, analyses have tended to be positive rather than normative, although some have examined the potential role of specific regulatory techniques in the USA (eg Lin, AC Size matters: regulating nanotechnology’ (2007) 31 Harvard Environmental Law Review 349 Google Scholar), and of international regulatory mechanisms (eg ; Bowman and Hodge, above n 11, pp 26–27).

52 Wilson, R and Crouch, EA Risk assessment and comparisons: an introduction’ (1987) 236(4799) Science 267 CrossRefGoogle Scholar, p 268.

53 See, eg, Sunstein, CR Lives, life-years, and willingness to pay’ (2004) 104 Columbia Law Review 205.CrossRefGoogle Scholar

54 For further detail, see Fisher, E Risk Regulation and Administrative Constitutionalism (Oxford: Hart, 2007 Google ScholarPubMed), particularly pp 40–47.

55 De Sadeleer, N The precautionary principle in Ec health and environmental law’ (2006) 12(2) European Law Journal 139 CrossRefGoogle Scholar at 141–144.

56 United Nations Report of the UN Conference on Environment and Development (A/CONF.151/26 (Vol I)), Annex I, Principle 15, available at http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm.

57 Posner, RA Catastrophe: Risk and Response (Oxford: Oxford University Press, 2004) p 172.Google Scholar

58 Majone, G What price safety? the precautionary principle and its policy implications’ (2002) 40(1) Journal of Common Market Studies 89 CrossRefGoogle Scholar at 101–104.

59 Sunstein, CR The paralyzing principle’ (2003) 25 Regulation 32 Google Scholar at 33.

60 Ogus, A Costs and Cautionary Tales: Economic Insights for the Law (Oxford: Hart, 2006) p 159.Google Scholar

61 Arrow, KJ et.al Is there a role for benefit-cost analysis in environmental, health and safety regulation?’ (1996) 272 Science 221 CrossRefGoogle Scholar at 221; Ogus, ibid, p 286; Posner, above n 57, p 173.

62 Sunstein, CR Laws of Fear: Beyond the Precautionary Principle (Cambridge: Cambridge University Press, 2005) p 113.CrossRefGoogle Scholar

63 Posner, above n 57, p 176.

64 Allianz Center for Technology Small Sizes that Matter: Opportunities and Risks of Nanotechnologies (Munich: Allianz Center for Technology, 2005) p 41 Google Scholar;

65 See, eg, Toth, FL Climate policy in light of climate science: the Iclips Project’ (2003) 56 Climate Change 7 CrossRefGoogle Scholar at 8–9.

66 For a good example of this approach, see Ogus, A Responding to threats of terrorism: how the law can generate appropriate incentives’ (2007) 19(1) Journal of Interdisciplinary Economics 35.CrossRefGoogle Scholar

67 It is recognised, however, that such mechanisms (particularly strict liability) may have an important role in this context.

68 Helland, A Nanoparticulate materials and regulatory policy in Europe: an analysis of stakeholder perspectives’ (2006) 8 Journal of Nanoparticle Research 709 CrossRefGoogle Scholar at 713–714.

69 Shavell, S On optimal legal change, past behaviour, and grandfathering’ (2008) 37(1) Journal of Legal Studies 37 CrossRefGoogle Scholar at 38.

70 Although see comments on transition costs (ibid, at 51–52).

71 Ibid. p 57.

72 CST, above n 2, p 11.

73 RS/RAEng, above n 2, p 49; HM Government, above n 33, p 4; CST, above n 2, p 11.

74 SCENHIR, above n 41, pp 35 and 51; Oberdörster, G et.al Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles’ (2005) 113(7) Environmental Health Perspectives 823 CrossRefGoogle ScholarPubMed at 824–825.

75 Defra Characterising the Potential Risks posed by Engineered Nanoparticles: A Second UK Government Research Report (London: Defra, 2007) p 26 Google Scholar; SCCP, above n 19, pp 26–27.

76 Posner, above n 57, p 148.

77 HSE, above n 9.

78 Eurobarometer Europeans and Biotechnology in 2005: Patterns and Trends EB64.3, available at http://ec.europa.eu/public_opinion/archives/eb_special_en.htm.

79 Siegrist, M et.al Public acceptance of nanotechnology foods and food packaging: the influence of affect and trust’ (2007) 49 Appetite 549.CrossRefGoogle ScholarPubMed

80 Siegrist, M et.al Risks and nanotechnology: the public is more concerned than experts and industry’ (2007) 2 Nature Nanotechnology 67 CrossRefGoogle ScholarPubMed;

81 Turn of phrase taken from the Corporate Manslaughter and Corporate Homicide: A Regulatory Impact Assessment of the Government's Bill p 4, available at http://www.homeoffice.gov.uk/documents/ria-corporate-manslaughter.pdf.

82 Jasanoff, S Designs on Nature: Science and Democracy in Europe and the United States (Princeton: Princeton University Press, 2005) pp 48–58.CrossRefGoogle Scholar

83 ETC Group No Small Matter! Nanotech Particles Penetrate Living Cells and Accumulate in Animal Organisms (2002); The Big Down – Atom Tech: Technologies Converging at the Nano-Scale (2003); No Small Matter II: The Case for a Global Moratorium – Size Matters! (2003), available at http://www.etcgroup.org.

84 CST, above n 2, Annex C, pp 54 and 132; Friends of the Earth (FoE) Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks (2006) p 17, available at http://www.foe.org/camps/comm/nanotech/nanocosmetics.pdf; FoE Nanotechnology and Sunscreens: A Consumer Guide for Avoiding Nano-Sunscreens (2007) p 8, available at http://www.foe.org/nano_sunscreens_guide/Nano_Sunscreens.pdf; Soil Association Nanotechnology Policy Review: Soil Association Response to DTI/Council for Science & Technology Consultation (2006), available at http://www2.cst.gov.uk/cst/business/files/Soil_Association.doc.

85 Ehrlich, I and Posner, RA An economic analysis of legal rulemaking’ (1974) 3(1) Journal of Legal Studies 257 CrossRefGoogle Scholar at 267.

86 Prime Minister Speech ‘Science Matters’ (23 May 2002), available at http://www.number10.gov.uk/Page1715.

87 CEC, above n 3, p 19.

88 Allianz Center, above n 64, pp 22–24.

89 Hullmann, A The Economic Development of Nanotechnology – An Indicators Based Analysis (Brussels: DG Research, CEC, 2006) pp 8–13.Google Scholar

90 Lux Research, Press Release ‘Revenue from Nanotechnology-Enabled Products to Equal IT and Telecom by 2014, Exceed Biotech by 10 Times’, 25 October 2004, available at http://www.luxresearchinc.com/press/RELEASE_SizingReport.pdf; Swiss Re, above n 64.

91 Micro & Nano Technology (MNT) Industrial Map of UK (MNT, 2006) available at http://mnt.globalwatchonline.com/epicentric_portal/site/MNT/menuitem.53e69ebac221f1cb628cca100680e1a0/; ‘Editorial’ (2007) 2(1) MNT Bulletin 1 Google Scholar at 1.

92 Eg Sunstein, CR Paradoxes of the regulatory state’ (1990) 57(2) University of Chicago Law Review 407 CrossRefGoogle Scholar at 417–421.

93 For an illustration of this point, see Corby Group Litigation v Corby Borough Council [2008] EWCA Civ 463.

94 See, eg, Biotech Products (EC – Approval and Marketing of Biotech Products) Panel Report: WT/DS291/R, WT/DS292/R, WT/DS293/R, 29 September 2006.

95 International Center for Technology Assessment, Press Release ‘Principles for the Oversight of Nanotechnologies and Nanomaterials’ 31 July 2007, available at http://www.icta.org.

96 Eg European Parliament and Council Water Framework Directive 2000/60/EC, as amended.

97 Paradise, J et.al Developing oversight frameworks for nanobiotechnology’ (2008) 9(1) Minnesota Journal of Law, Science & Technology 399.Google Scholar

98 Davies, above n 6, p 18.

99 Ogus, A Regulatory institutions and structures’ (2002) 73(4) Annals of Public and Cooperative Economics 627 CrossRefGoogle Scholar at 631.

100 Ogus, A Legal Form and Economic Theory (Oxford: Hart, 2004) p 238.Google Scholar

101 Lin, above n 51.

102 For related discussion, see Yeung, K Government by publicity management: sunlight or spin?’ (2005) Public Law 360 Google ScholarPubMed at 366–370.

103 See Kuran, T and Sunstein, CR Availability cascades and risk regulation’ (1999) 51(4) Stanford Law Review 683.CrossRefGoogle Scholar

104 Berkeley Municipal Code (amended through Ordinance No 6,960-NS January 2007), Chapter 6.95 of California Health and Safety Code, Title 15, available at http://www.ci.berkeley.ca.us.

105 Ibid.

106 Note the extent to which consumers can interpret this information will have a significant bearing on the effectiveness of its disclosure. Recipients of information often display ‘bounded rationality’: they are prevented from processing information rationally because their cognitive abilities are limited. Fishman, MJ and Hagerty, KM ‘Mandatory versus voluntary disclosure in markets with informed and uninformed customers’ (2003) 19(1) Journal of Law, Economics, & Organization 45 CrossRefGoogle Scholar illustrates that, although mandatory disclosure benefits ‘informed’ customers (ie those with the technical expertise necessary to process the information), it is neutral for ‘uninformed’ customers.

107 Bulmer, SJ New institutionalism and the governance of the Single European Market’ (1998) 5(3) Journal of European Public Policy 365.CrossRefGoogle Scholar

108 Scott, J and Trubek, DM Mind the gap: law and new approaches to governance in the European Union’ (2002) 8(1) European Law Journal 1 CrossRefGoogle Scholar at 1–2; ) ch 8, p 186.

109 Caporaso, JA and Wittenbrinck, J The new modes of governance and political authority in Europe’ (2006) 13(4) Journal of European Public Policy 471 CrossRefGoogle Scholar at 472.

110 Héritier, above n 108.

111 Jordan, A The European Union: an evolving system of multi-level governance... or government?’ (2001) 29 Policy & Politics 193.CrossRefGoogle Scholar

112 Scott and Trubek, above n 108, at 5–8; Scott, C Private regulation of the public sector: a neglected facet of contemporary governance’ (2002) 29(1) Journal of Law & Society 56.CrossRefGoogle Scholar

113 Eg CEC Recommendation on a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research C(2008) 424 final.

114 International Risk Governance Council (IRGC) Policy Brief Nanotechnology Risk Governance: Recommendations for a Global, Coordinated Approach to the Governance of Potential Risks (Geneva: IRGC, 2007) p 9.Google Scholar

115 Ibid p 9; Defra, above n 75, p 13; CEC Action Plan for European Standardisation (Brussels: DG Enterprise and Industry, CEC, 2008) pp 16–17 Google Scholar; CEC Accompanying Document to the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee – Regulatory Aspects of Nanomaterials SEC (2008) 2036, pp 37–38.

116 ISO Technical Committee 229; CEN Technical Committee 352.

117 ISO/Technical Specification 27687:2008.

118 ISO/Approved Work Item, Technical Specification 10929.

119 ISO/New Proposal 11931.

120 ISO/New Proposal 11937.

121 ISO/Approved Work Item, Technical Specification 11803.

122 ISO/Technical Report 12885.

123 House of Commons Science and Technology Committee Too Little Too Late? Government Investment in Nanotechnology Fifth Report of Session 2003–04, Vol I (London: The Stationary Office, 2004).

124 CST, above n 2, pp 5–6 and 15–17.

125 Defra, above n 75.

126 The REFNANO project and the Organisation for Economic Cooperation and Development also have a role in the development of nanotechnology standards.

127 O'Rourke, D Outsourcing regulation: analyzing nongovernmental systems of labor standards and monitoring’ (2003) 31(1) Policy Studies Journal 1.CrossRefGoogle Scholar

128 Héritier, above n 108, p 199.

129 Eg, the US Environmental Protection Agency ‘Nanoscale Materials Stewardship Program’.

130 Defra UK Voluntary Reporting Scheme for Engineered Nanoscale Materials (London: Defra, 2008) p 5.Google Scholar

131 Ibid, p 6.

132 CST, above n 2, p 27. See also Denison, RE Comments on EPA's ‘Concept Paper for the Nanoscale Materials Stewardship Program under TSCA’ and ‘TSCA Inventory Status of Nanoscale Substances – A General Approach’ (New York: Environmental Defense, 2007).Google Scholar

133 These figures represent the position in August 2008: Defra UK Voluntary Reporting Scheme for Engineered Nanoscale Materials: Seventh Quarterly Report (London: Defra, 2008).Google Scholar

134 Defra Consultation on a Voluntary Reporting Scheme for Engineered Nanoscale Materials: Summary of Findings and Government's Response (London: Defra, 2006) p 4.Google Scholar

135 Defra may be obliged (on request under the Freedom of Information Act 2000 or the Environmental Information Regulations 2004, SI 2004/3391) to provide information submitted to the Scheme to third parties. See Defra, above n 130, pp 4–5.

136 CST, above n 2, Annex C, pp 133–134.

137 Eg agricultural and pharmaceutical biotechnologies involving genetic engineering.