Risk and beyond: Eu regulation of nanotechnology

European Law Review

Volumn 35, Issue 6, 2010, Pages 799-821

  Lee, Maria ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Ethics; EU law; Nanotechnology; Regulation; Risk assessment

Indexed keywords

EID: 79551672048     PISSN: 03075400     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (211)

1. Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency [2006] OJ L396/1
2. see fhn.90-92. The corrigendum to REACH is the version that needs to be referred to, [2007] OJ LI36/3.
3. Regulation 258/1997 concerning novel foods and novel food ingredients [1997] OJ L43/1 is in the process of amendment. The latest version, Position 6/2010 of the Council at First Reading with a view to the adoption of a Regulation of the European Parliament and of the Council on novel foods [2010] OJ C122E/03 provides that: '"engineered nanomaterial' means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale." Properties "characteristic of the nanoscale" include: "those related to the large specific surface area of the materials considered" and/or "specific physico-chemical properties that are different from those of the non-nanoform of the same material", art 3(2)(c).
4. See also European Commission, Proposal for a Regulation of the European Parliament and of the Council on Novel Foods and amending Regulation (EC) No XXX/XXXX[common procedure] COM(2007) 872.
5. Regulation 1223/2009 on cosmetic products (recast) [2009] OJ L342/59, art.2(l)(k). Soluble and biodegradable nanomaterials are excluded from this definition: for discussion
6. see Scientific Committee on Consumer Products (SCCP), Opinion On Safety OfNanomateriab In Cosmetic Products, Adopted by the SCCP after the public consultation on the 14th plenary of December 18,2007 SCCP/1147/07. Unlike the food definition (see fn.2), this definition is limited by scale: more important is the way that the scale changes behaviour
7. House of Lords Select Committee on Science and Technology, 1st Report of Session 2009-10, Nanotechnologies and Food (HL Paper 22-1), Royal Commission on Environmental Pollution (RCEP), Twenty Seventh Report, Novel Materials in the Environment: The Case of Nanotechnology (Cm 7468,2008). (The author joined the Royal Commission on Environmental Pollution after the publication of this report on nanotechnology.)
8. Article 2(3). EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Basis for the Definition of the Term "Nanomaterial", July 6, 2010 is a public consultation on the definition of "nanomaterial", and considers the approach being taken by ISO and OECD.
9. On applications and research, see e.g. RCEP, (fn.3)
10. European Commission, Commission Staff Working Document: Accompanying document to the Communication from the Commission: Nanosciences and Nanotechnologies: An action plan for Europe 2005-2009. Second Implementation Report 2007-2009 SEC(2009) 1468.
11. See the detailed discussion in M. Lee, "Beyond Safety? The Broadening Scope of Risk Regulation" in C. O'Cinneide (ed.), Current Legal Problems 2009 (Oxford: Oxford University Press, 2010).
12. Note the removal of carbon and graphite from Annex IV of REACH, (see fn.1), which contains a list of substances posing minimum risk that are excluded from registration requirements: R. Lee and S. Vaughan, "REACHing down: Nanomaterials and Chemical Safety in the European Union" forthcoming, Journal of Law, Innovation and Technology.
13. This scenario comes from K.E. Drexler, Engines of Creation (New York: Anchor Books, 1986), an early champion of nanotechnology viewed as molecular level engineering.
14. There are cost benefit approaches, see R. Posner, Catastrophe: Risk and Response, (Oxford: Oxford University Press, 2004)
15. "Efficient Responses to Catastrophic Risk" (2005-2006) 6 Chicago Journal of International Law 511, arguing that we under-examine catastrophe in decision-making. The value judgments at stake are implicit (or sometimes explicit) in the economic approach he advocates, e.g. he acknowledges that in respect of his analysis of the Relativisitic Heavy Ion Collider, the "probability estimate is arbitrary", 520. There is of course a danger that the value judgments are rendered invisible by the cost benefit approach.
16. For discussion of environmental ethics.
17. see e.g. J. Alder and D. Wilkinson, Environmental Law and Ethics (Macmillan Press, 1999)
18. R Attfield, Environmental Ethics: An Overview for the Twenty-First Century (Polity Press, 2003). From a different angle
19. see D.A. Kysar, Regulating from Nowhere: Environmental Law and the Search for Objectivity (Yale University Press, 2010).
20. For both of these arguments, see Nuffield Council on Bioethics, Genetically Modified Crops: the Ethical and Social Issues (Nuffield Council on Bioethics, 1999).
21. See e.g. Nuffield Council on Bioethics, Genetically Modified Crops: the Ethical and Social Issues (Nuffield Council on Bioethics, 1999).
22. See the discussion of competitiveness in A. Jamison, "Can Nanotechnology Be Just? On Nanotechnology and the Emerging Movement for Global Justice" (2009) 3 Nanoethics 129.
23. See the discussion of "beneficent" regulation in H.T. Demissie, "Is Beneficent Regulation the New Better Regulation? Nano-regulation in the Wake of the 'New Better Regulation Movement'" (2010) Law, Innovation and Technology, forthcoming
24. See RCEPinm.3,[3.12].
25. V. Heyvaert, "Globalizing Regulation: Reaching Beyond the Borders of Chemical Safety" (2009) 36 Journal of Law and Society 110.
26. Generally, see RCEP (fn.3)
27. SCENIHR, Risk Assessment of Products of Nanotechnologies, January 19, 2009, p.8
28. 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, June 21-22, 2007
29. Council Position (see fh.2): "At present, there is inadequate information on the risks associated with engineered nanomaterials. In order to better assess their safety the Commission, in cooperation with the Authority, should develop test methodologies which take into account specific characteristics of engineered nanomaterials" Recital 20.
30. SE. Fisher, "The 'Perfect Storm' of REACH: Charting Regulatory Controversy in the Age of Information, Sustainable Development and Globalization" (2008) 11 Journal of Risk Research 541.
31. European Commission, Recommendation of 07/02/2008 on a code of conduct for responsible nanosciences and nanotechnologies research, C(2008) 424 final, [4.1.17].
32. e.g. European Commission, Nanosciences and nanotechnologies: An Action Plan for Europe 2005-2009 COM(2005) 243 final and associated implementation reports: European Commission, Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009
33. Second Implementation Report 2007-2009 COM(2009) 607 final
34. European Commission, Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. First Implementation Report 2005-2007 COM(2007) 505 final.
35. e.g. both SCENIHR reports (see m. 17)
36. European Commission, Second Implementation Report, (fn.20), 4
37. Competent Authorities Sub Group on Nanomaterials, (CASG-Nano), Follow-up to the 6th Meeting of the REACH Competent Authorities for the implementation of Regulation (EC) 1907/2006 (REACH), CA/59/2008 rev.1, [2.4].
38. Regulation 1907/2006, (see fn.1). The controversy surrounding the information requirements of REACH remind us that information is often very far from a "soft" regulatory requirement.
39. So T. Assmuth, M. Hilden and M. Craye, "Beyond REACH: Roadblocks and shortcuts en route to Integrated Risk Assessment and Management of Chemicals" (2010) Science of the Total Environment 3954, concludes that REACH provides "rather limited provisions for integrated assessment of cumulative risks from multiple stressors", 3960.
40. SCENIHR (2009): see rh.17 and 13.
41. B. Wynne, "Uncertainty and Environmental Learning: Reconceiving Science and Policy in the Preventive Paradigm" [1992] Global Environmental Change 111.
42. See C.R. Sunstein, "Beyond the Precautionary Principle" (2003) 151 University of Pennsylvania Law Review 1003
43. C.R. Sunstein, Risk and Reason: Safety, Law, and the Environment (Cambridge: Cambridge University Press, 2002).
44. J. Steele, Risks and Legal Theory (Oxford: Hart Publishing, 2004), p.33.
45. Expert Group on Science and Governance, Taking European Knowledge Society Seriously (European Commission, 2007) [6.4].
46. I explore in detail the acceptance of the broad nature of risk regulation, and the difficulty of bringing it into regulatory activity at domestic, EU and WTO level in Lee, (see fh.6).
47. Communication on the Precautionary Principle COM(2000) 1 final [6.3.5].
48. European Commission, An Action Plan for Europe, (see fh.20)
49. The preparatory document, European Commission, Towards A European Strategy for Nanotechnology COM(2004) 338 final provided that "Societal impacts need to be examined and taken into account", 3.
50. European Commission, First Implementation Report (see fh.20), 7
51. European Commission, Second Implementation Report (see fh.20), s.5.
52. See also European Commission, European Activities in the field of Ethical, Legal, and Social Aspects (ELSA) and Governance of Nanotechnology (European Commission, 2008).
53. See the "folktales" told about the trajectory of GMOs in D.J. Sylvester, K.W. Abbott and G.E. Marchant, "Not Again! Public Perception, Regulation, and Nanotechnology" (2009) 3 Regulation and Governance 165.
54. European Commission, An Action Plan for Europe (fn.20), 2. In the United Kingdom, the subtitle of the UK Nanotechnologies Strategy: Small Technologies, Great Opportunities (2010) says it all.
55. See the discussion in M. Kearnes et al, "From Bio to Nano: Learning Lessons from the UK Agricultural Biotechnology Controversy" (2006) 15 Science as Culture 291, although not in the context of EU nanotechnology policy. See the concern with prediction in European Commission, An Action Plan for Europe (fh.20), [5.1].
56. P. MacNaghten, M.B. Kearnes, B. Wynne, "Nanotechnology, Governance, and Public Deliberation: What Role for the Social Sciences?" (2005) 27 Science Communication 268,273, of the US approach.
57. T. Rogers-Hayden and N. Pidgeon, "Reflecting Upon the UK's Citizens' Jury on Nanotechnologies: NanoJury UK" (2006) 3 Nanotechnology Law & Business 167
58. UK Nanotechnologies Strategy (fh.34), [85].
59. M. Godman and S.O. Hansson, "European Public Advice on Nanobiotechnology-Four Convergence Seminars" (2009) 3 Nanoethics 43, 50.
60. J. Macoubrie, "Nanotechnology: Public Concerns, Reasoning and trust in Government" (2006) 15 Public Understanding of Science 221, 236.
61. Regulation 1223/2009 on cosmetic products (recast) [2009] OJ L342/59 recital 9.
62. See R. Brownsword, "Nanoethics: Old Wine, New Bottles?" (2009) 32 Journal of Consumer Policy 355
63. F. Allhof, "What are Applied Ethics?" (2010) Science and Engineering Ethics
64. M. Godman, "But is it Unique to Nanotechnology? Refraining Nanoethics" (2008) 14 Science and Engineering Ethics 391.
65. I am concerned for now only with the place of nanomaterials in products, rather than in processes or activities, in order to examine decision-making at EU level rather than EU governance of decision-making at the national or local level.
66. European Commission, Regulatory Aspects of Nanomaterials COM(2008) 366 final; European Commission, Commission Staff Working Document: Accompanying document to the Communication Regulatory Aspects of Nanomaterials SEC(2008) 2036.
67. See also RCEP (fh.3); Royal Society and the Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties (Royal Society, 2004).
68. R. Lee and E. Stokes, "Twenty-first Century Novel: Regulating Nanotechnologies" (2009) 21 Journal of Environmental Law 469. The European Parliament disagrees "with the Commission's conclusions that a) current legislation covers in principle the relevant risks relating to nanomaterials, and b) that the protection of health, safety and the environment needs mostly be enhanced by improving implementation of current legislation". Its reason for disagreeing is that "due to the lack of appropriate data and methods to assess the risks relating to nanomaterials it is effectively unable to address their risks".
69. See European Parliament Resolution of 24 April 2009 on regulatory aspects of nanomaterials (2008/2208(INI) P6-TA(2009)0328, [3].
70. See European Commission at fh.30.
71. The General Food Law approach to "risk analysis" is explicitly divided into scientific "risk assessment" and political "risk management". Regulation 178/2002 Laying Down the General Principles and Requirements of Food Law, Establishing the European Food Safety Authority and Laying Down Procedures in Matters of Food Safety, art.3, 6[2002]OJL31/1.
72. REACH (see fh.1), Regulation 178/2002 Laying Down the General Principles and Requirements of Food Law art.77; (see fh.46), Chapter III, and Regulation 1223/2009 on cosmetic products (recast) [2009] OJ L342/59, e.g. art. 16 respectively.
73. (see fh.46), Chapter III, and Regulation 1223/2009 on cosmetic products (recast) [2009] OJ L342/59, e.g. art. 16 respectively
74. Decision 1999/468, Laying Down the Procedures for the Exercise of Implementing Powers Conferred on the Commission [1999] OJ LI84/23.
75. See the discussion in M. Lee, "EU Multi-level Governance of Genetically Modified Organisms: Ambiguity and Hierarchy" in M. Cardwell and L. Bodiguel (eds), The Regulation of Genetically Modified Organisms: Comparative Approaches (Oxford: Oxford University Press, 2009).
76. Pfizer Animal Health SA v Council of the European Union (T-13/99) [2002] E.C.R. 11-3305 at [201] and [199]. Whilst Pfizer has been very heavily cited by both judiciary and academics, there has been no explicit confirmation of these statements by the ECJ.
77. Alpharma Inc v Council of the European Union (T-70/99) [2002] E.C.R. II-3495 at [213].
78. See E. Fisher, Risk: Regulation and Administrative Constitutionalism (Oxford: Hart Publishing, 2007).
79. The precautionary principle can be used in a number of contexts, as an aid to interpretation (e.g. "safeguard" clauses "must be interpreted having due regard to this principle", Monsanto Agricoltura Italia SpA v Presidenza del Consiglio dei Ministri (C-236/01) [2003] E.C.R. 1-8105 at [110]
80. To defend regulatory action (e.g. Pfizer (T-13/99) [2002] E.C.R. II-3305 at the EU level, Commission of the European Communities v Netherlands ("Dutch Vitamins") (C-41/02) [2004] E.C.R. 1-11375 at the national level)
81. In the implementation of directives (e.g. Landelijke Vereniging tot Behoud van de Waddenzee v Staatssecretaris van Landbouw, Natuurbeheer en Visserij (Cocklefishers) (C-12 7/02) [2004] E.C.R. 1-7405).
82. Sweden v Commission (T-229/04) [2007] E.C.R. 11-2437 (on paraquat) is a case in point, where the precautionary principle seems to be used more to emphasise the level of risk that can be allowed, rather than addressing uncertainty, and is highly dependent on the specific regulatory context. Similarly (and although these were not cases about the precautionary principle), in the challenges to national allocation plans under Directive 2003/87 establishing a scheme for greenhouse gas emission allowance trading within the Community [2003] OJ L275/32, the allocation of authority between member state and Commission in the Directive was key to the role of technical evidence
83. see Poland v Commission (T-183/07) September 23, 2009
84. Estonia v Commission (T-263/07) September 23, 2009
85. see J. Scott, "The Multi-Level Governance of Climate Change" in R Craig and G. de Burca (eds), Evolution of EULaw 2nd edn (Oxford University Press, forthcoming 2010).
86. E. Stokes, "The EC Courts' Contribution to Refining the Parameters of Precaution" (2008) 11 Journal of Risk Research 491 examines the move to harder science in court decisions on the precautionary principle
87. Fisher (see fh.51), Ch.6, identifies a change of approach following European Commission (fh.29).
88. J. Corlcin, "Science, Legitimacy and the Law: Regulating Risk Regulation Judiciously in the European Community" (2008) 33 European Law Review 359 provides an excellent discussion of the sensitivity of the judiciary to both scientific and lay voices; however, this is largely through an absence of scrutiny of "minority" science, which is problematic in terms of accountability
89. Commission v France (C-333/08) January 28, 2010
90. Solgar Vitamins France v Ministre de I' Economie, des Finances andde I'Emploi (C-446/08) April 29,2010, uses similar language, although with more emphasis on the inadequacy of the data: "where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures" at [70].
91. Pfizer (T-13/99) [2002] E.C.R. 11-3305
92. Monsanto AgricolturaItaliaSpA (C-236/01) [2003] E.C.R. 1-8105. More recently
93. see Solgar Vitamins France (C-446/08) April 29, 2010 and Commission v France (C-333/08) January 28, 2010.
94. See Pfizer (T-13/99) [2002] E.C.R. 11-3305; European Commission (fh.30). Note that the meaning of zero risk is not entirely clear, and reducing a scientifically evidenced risk to zero is acceptable.
95. REACH (see fn.1).
96. Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified Organisms and Repealing Directive 90/220 [2001] OJ LI06/1.
97. Including C. Garcia Molyneux "Chemicals", Yearbook of European Environmental Law Vol.8 403
98. V. Heyvaert, "No Data, No Market. The Future of EU Chemicals Control under the REACH Regulation" (2007) 9 Environmental Law Review 201.
99. E. Stokes, "Regulating Nanotechnologies: Sizing up the Options" (2009) 29 Legal Studies 281
100. Lee and Vaughan (fn.7).
101. An existing chemical is listed in the European Inventory of Existing Commercial Chemical Substances, and so was available on the European market between January 1, 1971 and September 18, 1981.
102. Article 5. J. Scott, "REACH: Combining Harmonization and Dynamism in the Regulation of Chemicals" in J. Scott (ed), Environmental Protection: European Law and Governance (Oxford: Oxford University Press, 2009)
103. Fisher (fn. 18).
104. "Substance" means "a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition", art.3( 1). REACH applies to substances on their own or in preparations, and substances in articles where the substance "is intended to be released under normal or reasonably foreseeable conditions of use", arts 6-7. The inclusion of substances in articles greatly expands the scope of the regulations, although somewhat less stringent requirements apply.
105. see G. Molyneux (fn.61).
106. Article 10, art. 12(1).
107. See the Annexes to the regulation, which are triggered at different volumes.
108. Article 14. The threshold is subject to review, art. 13 8.
109. CASG, (fh.21), 6. European Commission, Regulatory Aspects, (see fh.43), which also says that it may be necessary to revisit thresholds in some legislation in the light of new information becoming available, 3. For classification and labelling purposes, the bulk and nanoscale may require separate classification and labelling if available data on the intrinsic properties indicates a different in hazard class. European Commission, Classification, labelling and packaging of nanomaterials in REACH and CLP, December 3,2009, CA/90/2009/Rev2, [2.2] citing REACH art.lO(a).
110. CASG (see fh.21), 10. Work of the CASG is ongoing. REACH applied to new substances from 2007, and is phased in for other substances between 2010 and 2018.
111. CASG (fh.21), [2.6].
112. Fisher (fh.18). V. Heyvaert, "Regulating Chemical Risk: REACH in a Global Governance Perspective" in J. Eriksson, M. Gilek, and C. Ruden (eds), Regulating Chemical Risks: European and Global Challenges (Springer, 2010).
113. See N. Gunningham, "Regulating Biotechnology: Lessons from Environmental Policy" in H. Somsen (ed.), The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents (Edward Elgar, 2007).
114. See the discussion of conflict of interest in K. Shrader- Frechette, "Nanotoxicology and Ethical Conditions for Informed Consent" (2007) 1 Nanoethics 47.
115. Scott (fh.64).
116. Articles 40 and 41. At 100 and 1000 tonne mark, registration includes testing proposals for the provision of information rather than the information itself.
117. Article 11. Note the discussion of the role of peers in ensuring corporate responsibility more generally, N. Gunningham, "Corporate environmental responsibility - law and the limits of voluntarism" in D. McBarnet, A. Voiculescu and T. Campbell (eds), The New Corporate Accountability: Corporate Social Responsibility and the Law (Cambridge: Cambridge University Press, 2007).
118. C. Hey, K. Jacob and A. Volkery, "Better Regulation by New Governance Hybrids? Governance models and the reform of European Chemicals Policy" FFU Report 02/2006 argue that registrants have incentives to underestimate the extent of the risk.
119. Article 44.
120. CASG(seefh.21), 15.
121. Article 56.
122. Articles 58, 59. For detailed, clear discussion
123. see Scott (fh.64).
124. Article 58(4).
125. Articles?.
126. Article 64(3).
127. Article 64(8). Note that authorisation was initially subject to the advisory procedure not the regulatory procedure
128. see Heyvaert (fh.72), and the original version rather than the Corrigendum (fh.l).
129. Article 60(2).
130. Annex I, s.6.4: "For any exposure scenario, the risk to humans and the environment can be considered to be adequately controlled, throughout the lifecycle of the substance that results from manufacture or identified uses, if: "The exposure levels estimated in Section 6.2 do not exceed the appropriate DNEL [derived no-effect level] or the PNEC [predicted no-effect concentration], as determined in Sections 1 and 3, espectively" and: "The likelihood and severity of an event occurring due to the physicochemical properties of the substance as determined in Section 2 is negligible."
131. Article 60(3). Note that the first authorisation condition can never apply to PBTs or vPvBs, art.60(3).
132. Lee and Vaughan, "REACHing down: Nanomaterials and Chemical Safety in the European Union" forthcoming, Journal of Law, Innovation and Technology.
133. Article 60. Criteria include technical and economic feasibility, art.60(5)(b).
134. ECHA, Guidance on Socio-Economic Analysis: Restrictions (May 2008)
135. Guidance on Socio-economic analysis for authorisation is not yet available.
136. S. Foss Hansen, L. Carlsen and J.A. Tickner, "Chemicals Regulation and Precaution: Does REACH Really Incorporate the Precautionary Principle?" (2007) 10 Environmental Science and Policy 395.
137. Article 68(1).
138. Article 69(1).
139. Article 69(6).
140. Article 68(1).
141. Stokes, "Regulating Nanotechnologies: Sizing up the Options" (2009) 29 Legal Studies 281. Lee and Vaughan, "REACHing down: Nanomaterials and Chemical Safety in the European Union" forthcoming, Journal of Law.
142. Innovation and Technology. V. Heyvaert, "The EU's Chemicals Policy: Towards Inclusive Governance?" in E. Vos (ed), European Risk Governance: Its Science, Its Inclusiveness and Its Effectiveness (CONNEX report series No.6, 2008) observes that some in EINICS would fall outside.
143. Article 44.
144. For interesting detail, see D.M. Bowman and G. van Calster, "Flawless or Fallible? A Review of the Applicability of the European Union's Cosmetics Directive in Relation to Nano-Cosmetics" (2008) 2 Studies in Ethics, Law and Technology 1.
145. SCCP(seefh.3).
146. Regulation 1223/2009 on cosmetic products (recast) [2009] OJ L342/59.
147. Article 3.
148. Article 10. The "responsible person" will usually be the EU based manufacturer or importer
149. see art.4.
150. Annex I, para.6.
151. Article 14(l)(a), Annex II. Substances classed as carcinogenic, mutagenic or toxic for reproduction (CMR) are prohibited unless subject to a positive finding that it is "safe for use in cosmetic products" by the Scientific Committee for Consumer Safety, art. 15. Slightly different criteria apply to the different categories of CMR.
152. Article 14(l)(b), Annex III.
153. Article 14(l)(c)(d)(e), Annexes IV-VI.
154. Article 31.
155. Article 16(5).
156. Article 16(6). Through comitology, using the regulatory procedure with scrutiny.
157. Article 16(2). SCCP (th.3) says that it is necessary to look again at nanoscale titanium dioxide.
158. E. Stokes, "Regulating Nanotechnologies: Sizing up the Options" (2009) 29 Legal Studies 281.
159. Article 16(10)(a)
160. Article 19(1).
161. See fn.2, [2.2(vi)(b)]. Note that the House of Lords Select Committee (fh.3), is concerned about industry's lack of transparency but does not support mandatory labelling. In this it follows RCEP (fn.3). For discussion of informed consent and labelling.
162. see K. Shrader-Frechette, "Nanotoxicology and Ethical Conditions for Informed Consent" (2007) 1 Nanoethics 47.
163. J. Scott, "From Brussels with Love: The Transatlantic Travels of European Law and the Chemistry of Regulatory Attraction" (2009) 57 American Journal of Comparative Law 897, 922. Note that additional labelling obligations may be imposed in the restrictions process.
164. 'European Food Safety Authority, The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety (Scientific Opinion of the Scientific Committee) (2009) 958 The EFSA Journal 1, summary. House of Lords Select Committee (fn.3) contains a useful discussion.
165. "Nanotechnologies used in food wrappings are regulated by Regulation 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590 and 89/109 [2004] OJ L338/4.
166. "Regulation 178/2002 Laying Down the General Principles and Requirements of Food Law (art. 14).
167. Novel food is food that "has not been used for human consumption to a significant degree within the Community before 15 May 1997", Council position (see fh.2), art.3(2)(a).
168. See N. Salmon, "What's cooking? From GM food to Nanofood: Regulating Risk and Trade in Europe" (2009) 11 Environmental Law Review 97.
169. Regulation 178/2002 Laying Down the General Principles and Requirements of Food Law recital 19.
170. See also Council position (fh.2) recital 18.
171. Council Position (fh.2) relies on a "common authorisation procedure", recital 18, art.9, found in Regulation 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings [2008] OJ L354/1, art.7 in particular.
172. Regulation 178/2002 Laying Down the General Principles and Requirements of Food Law art.1.
173. Council position (fh.2), art.1.
174. Council position (fh.2) art.8.
175. Regulation 178/2002 Laying Down the General Principles and Requirements of Food Law art.l4(l). "Food shall be deemed to be unsafe if it is considered to be: (a) injurious to health; (b) unfit for human consumption" (art.l4(2)). More specific provisions apply to particular food stuffs, art. 14(7) and (8).
176. Council position (fh.2), art.8.
177. For detail, specifically in respect of GMOs
178. see M. Lee, EU Regulation ofGMOs: Law and Decision-making for a New Technology (Edward Elgar, 2008).
179. Stokes, "Regulating Nanotechnologies: Sizing up the Options" (2009) 29 Legal Studies 281.
180. E.g. for cosmetics, see text at fh.104.
181. See the discussion in I. Rafols et al, "Missing Links in Nanomaterials Governance: Bringing Industrial Dynamics and Downstream Policies into View" (2010) SPRU Electronic Working Papers Series No 180.
182. Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified Organisms [2001] OJL106/lart.29.
183. Directive 1998/44 on the Legal Protection of Biotechnological Inventions [1998] OJ L213/13, arts 7 and 6. Some inventions (processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; uses of human embryos for industrial or commercial purposes; processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes) are deemed to be contrary to ordre public/morality.
184. Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified Organisms [2001] OJ L106/1 art.29(3).
185. Commission v Poland (C-165/08) [2009] E.C.R. 1-6843 at [19].
186. Commission v Poland (C-165/08) [2009] E.C.R. 1-6843 at [31].
187. Commission v Poland (C-165/08) [2009] E.C.R. 1-6843 at [52].
188. Commission vPoland(C-165/0&) [2009] E.C.R. 1-6843 at [55].
189. Expert Group on Science and Governance, Taking European Knowledge Society Seriously (European Commission, 2007).
190. See the discussion in Lee, "Beyond Safety? The Broadening Scope of Risk Regulation" in C. O'Cinneide (ed.), Current Legal Problems 2009 (Oxford: Oxford University Press, 2010).
191. MacNaghten et al, "Nanotechnology, Governance, and Public Deliberation: What Role for the Social Sciences?" (2005) 27 Science Communication 268, 273.
192. J. Wilsdon and R. Willis, See-through Science: Why Public Engagement Needs to Move Upstream (Demos, 2004)
193. Royal Society and Royal Academy of Engineering (fh.43)
194. MacNaghten et al, "Nanotechnology, Governance, and Public Deliberation: What Role for the Social Sciences?" (2005) 27 Science Communication 268, 273.
195. Although on outputs see D. Pesendorfer, "EU Environmental Policy under Pressure: Chemicals Policy Change between Antagonistic Goals?" (2006) 15 Environmental Politics 95.
196. Heyvaert, "The EU's Chemicals Policy: Towards Inclusive Governance?" in E. Vos (ed), European Risk Governance: Its Science, Its Inclusiveness and Its Effectiveness (CONNEX report series No.6, 2008)
197. Regulation 178/2002 Laying Down the General Principles and Requirements of Food Law art.9
198. Regulation 1331/2008 establishing a common authorisation procedure for food additives [2008] OJ L354/1 recital 10; although the body of the regulation refers only to consultation of the applicant, there is some emphasis on public transparency and information provision.
199. Regulation 1223/2009 on cosmetic products (recast) [2009] OJ L342/59, e.g. art. 10.
200. European Group on Ethics in Science and New Technologies, Opinion no 25, Ethics of synthetic biology (2009)
201. Group of Advisors to the European Commission on the Ethical Implications of Biotechnology, Opinion No.l, The ethical implications of the use of performance-enhancers in agriculture and fisheries (1993).
202. European Group on Ethics in Science and New Technologies, Opinion no 2I, Ethical Aspects of Nanomedicine (2007).
203. See fh.147; the Opinion itself notes the "combined use of synthetic biology and nanotechnology", p.24.
204. See fh.147; the Opinion itself notes the "combined use of synthetic biology and nanotechnology", p.24. ObservatoryNano, 2nd Annual report on Ethical and Societal Aspects of Nanotechnology, nanobioethics (2010) notes the importance of this Opinion.
205. European Group on Ethics in Science and New Technologies, Opinion no 24, Ethics of modern developments in agricultural technologies (2008).
206. E.g., European Commission, Working document (see fh.43). They also turn to EGE for new problems, e.g. European Commission, Second Implementation Report (fn.21), "The likely convergence of nanotechnology with biotechnology, information technology and cognitive sciences increases opportunities for beneficial applications, but also raises important questions relating to ethics, safety, security and respect for fundamental rights. These may need to be addressed by a new opinion of the European Group on Ethics in Science and New Technologies", 7.
207. S. Kelly, "Public bioethics and publics: Consensus, Boundaries, and Participation in Biomedical Science Policy" (2003) 28 Science. Technology & Human Values 339, 347.
208. H. Busby, T. Hervey and A. Mohr, "Ethical EU law? The Influence of the European Group on Ethics in Science and New Technologies" (2008) European Law Review 803, describing the EGE as a "grey governance body".
209. MBusby et al, "Ethical EU law? The Influence of the European Group on Ethics in Science and New Technologies" (2008) European Law Review 803. Directive 1998/44 on the Legal Protection of Biotechnological Inventions [1998] OJ L213/13.
210. European Group on Ethics in Science and New Technologies, Opinion no 3, Ethical questions arising from the Commission proposal for a Council directive on legal protection for biotechnological inventions (1993).
211. Expert Group on Science and Governance, Taking European Knowledge Society Seriously (European Commission, 2007) [4.3.1].