Acknowledgements |
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v | |
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xiii | |
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xvii | |
Introduction: Regulating the Invisible |
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xxix | |
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1 Setting the Scene: Nanotechnologies and their Regulation at the EU Level |
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1 | (13) |
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I What are Nanotechnologies? |
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1 | (2) |
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II Between Nanomania and Nanophobia |
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3 | (2) |
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III Risk as a Rationale for Regulatory Intervention |
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5 | (2) |
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IV The EU's Approach to the Regulation of Nanotechnologies: A Bird's Eye Perspective |
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7 | (5) |
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A The EU's Incremental Approach to Nanotechnologies |
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7 | (2) |
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9 | (2) |
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11 | (1) |
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12 | (2) |
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2 Regulating in Today's Nano Society |
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14 | (26) |
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I Embedding the Regulation of Nanotechnologies in Its Societal Context |
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14 | (6) |
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15 | (1) |
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B Functional Differentiation |
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16 | (1) |
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C The Rise of the Risk Society |
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17 | (2) |
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D Through the Lenses of Nanotechnologies |
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19 | (1) |
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II Regulating in Today's Nano Society: Two Theoretical Accounts |
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20 | (7) |
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20 | (3) |
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23 | (3) |
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C Grasping the `Procedural Turn' |
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26 | (1) |
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III Translating the Debate to the EU Level |
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27 | (11) |
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A The Rise of `New Modes of Governance' |
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28 | (2) |
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i The White Paper on European Governance |
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30 | (1) |
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ii The Concept of `New (Modes of) Governance' |
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31 | (2) |
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B The Rise of European Risk Regulation |
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33 | (2) |
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35 | (1) |
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36 | (2) |
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IV Conclusion and Next Steps |
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38 | (2) |
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3 Analysing EU (Risk) Regulation through the Lenses of Regulatory Capacity |
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40 | (32) |
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I Denning the Object of Analysis: `EU Regulation' |
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40 | (9) |
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A Excursus: Law, Regulation and Governance |
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40 | (4) |
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44 | (1) |
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C The Regulatory Spectrum at the EU Level |
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45 | (1) |
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45 | (1) |
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46 | (3) |
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D The Object of Analysis: `EU Regulation' |
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49 | (1) |
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II Putting on the Analytical Lenses of Regulatory Capacity |
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49 | (21) |
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A First Element: Pooling Knowledge |
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50 | (1) |
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50 | (1) |
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ii The Impact Assessment as a Procedure to Pool Knowledge |
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51 | (4) |
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iii Extending the Impact Assessment Procedure to Parliament and Council |
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55 | (2) |
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B Second Element: Ensuring Legitimate Regulation |
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57 | (1) |
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57 | (2) |
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ii Participation at the EU Level |
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59 | (5) |
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iii Holding the EU Regulator to Account |
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64 | (6) |
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70 | (2) |
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4 Nanotechnologies in Food |
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72 | (72) |
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I Nanotechnologies in Food |
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72 | (5) |
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A Innovating Food Production and Processing |
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72 | (1) |
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B Applications of Nanotechnologies in Food |
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73 | (1) |
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i Nanomania: Exploiting Nanotechnologies for the Food Sector |
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74 | (1) |
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ii Nanophobia: Environmental, Health and Safety Risks of Nanofoods |
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75 | (1) |
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C The EU Food Industry and Nanotechnologies |
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76 | (1) |
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II The EU Regulatory Framework for Nanotechnologies in Food |
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77 | (17) |
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A EU Legislative Framework for Food: Fit for Nano? |
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77 | (1) |
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78 | (1) |
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79 | (6) |
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iii State of Play: A Cautious European Commission |
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85 | (1) |
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B Addressing Nanotechnologies via the Executive Route |
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86 | (1) |
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i Via Comitology: Implementing Acts under the FCM Regulation |
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87 | (1) |
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ii Via Agency Guidance Documents: EFSA's Guidance on Risk Assessment of Nanotechnologies in Food and Feed |
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88 | (1) |
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iii Via Commission Recommendations: Denning the Term `Nanomaterial' |
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89 | (4) |
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iv Synthesis: Towards Executive Rule Making |
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93 | (1) |
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III Analysing the EU's Regulation of Nanofoods through the Lenses of Regulatory Capacity |
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94 | (47) |
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94 | (1) |
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i The Impact Assessment: A Tool to Pool Knowledge? |
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95 | (4) |
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ii Knowledge Collection through Commission Expert Groups |
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99 | (2) |
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iii Knowledge Collection in the Drafting of EFSA's Guidance Document |
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101 | (2) |
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iv Synthesis: Pooling Knowledge in the Drafting of a Regulatory Framework for Nanotechnologies in Food |
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103 | (3) |
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106 | (1) |
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i Political Participation |
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107 | (1) |
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ii Administrative Participation |
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108 | (9) |
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iii Synthesis: Participation in Nano Practice |
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117 | (1) |
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118 | (1) |
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i Political Accountability vis-a-vis the European Parliament |
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118 | (5) |
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ii Legal Accountability: The Role of the EU Courts |
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123 | (10) |
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iii Administrative Accountability: Making Way for the EU Ombudsman |
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133 | (3) |
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iv Social Accountability: A Transparent Regulatory Process? |
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136 | (4) |
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v Synthesis: Holding the EU Regulator to Account |
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140 | (1) |
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141 | (3) |
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5 Nanotechnologies in Chemicals |
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144 | (55) |
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I Nanotechnologies in Chemicals |
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144 | (4) |
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144 | (1) |
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B Applications of Nanotechnologies in the Chemicals Sector |
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145 | (1) |
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146 | (1) |
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147 | (1) |
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C The EU Chemicals Sector and Nanotechnologies |
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148 | (1) |
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II The EU Regulatory Framework for Nanotechnologies in Chemicals |
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148 | (18) |
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A Reforming the EU Chemicals Policy |
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148 | (2) |
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i REACH and Its Main Pillars |
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150 | (4) |
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154 | (4) |
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iii Revising REACH? No But Yes |
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158 | (2) |
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B Addressing Nanotechnologies via Comitology |
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160 | (1) |
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C Addressing Nanotechnologies via ECHA Guidance Documents |
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160 | (2) |
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i ECHA Guidance on Information Requirements and Chemical Safety Assessment |
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162 | (2) |
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ii ECHA Guidance on Nanomaterials in IUCLID 5 |
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164 | (1) |
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D The State of Play: Spotlight on the EU Executive |
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165 | (1) |
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III Analysing the EU's Regulation of Nanochemicals through the Lenses of Regulatory Capacity |
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166 | (31) |
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167 | (1) |
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i Pooling Knowledge in the Drafting of the REACH Implementing Act(s) |
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167 | (3) |
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ii Pooling Knowledge in the Drafting of ECHA's Guidance Documents |
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170 | (9) |
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iii Synthesis: Pooling Knowledge |
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179 | (1) |
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180 | (1) |
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i Participation in the Drafting of REACH'S Implementing Act(s) |
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181 | (3) |
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ii Participation in the Drafting of ECHA's Guidance Documents |
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184 | (4) |
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iii Synthesis: From Parliamentary Absence and a Cosy Stakeholder Collaboration |
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188 | (2) |
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190 | (1) |
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i The Parliament's ex post Scrutiny of ECHA's Guidance Documents |
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190 | (1) |
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ii In Legal Twilight: The Role of the EU Courts |
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191 | (2) |
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iii Administrative Accountability: The Expandable Role of the European Ombudsman |
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193 | (1) |
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iv Social Accountability: Transparency on Paper |
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194 | (2) |
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v Synthesis: Holding ECHA to Account |
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196 | (1) |
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197 | (2) |
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199 | (26) |
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I Regulating in Today's Nano Society: The Point of Departure |
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199 | (1) |
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II Spotlight on the EU Executive |
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200 | (1) |
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III Main Findings of the Critical Analysis or the Pitfalls of `New Governance' |
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201 | (5) |
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A The Impact Assessment: Between Empty Proceduralisation and Strategic Choice |
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201 | (1) |
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B The Fragmentary Proceduralisation of EU Agency Rule Making |
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202 | (1) |
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C Depoliticisation: Towards Technocratic Rule? |
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203 | (1) |
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i The Lack of Parliamentary Involvement |
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203 | (1) |
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ii The Spectacle of Administrative Participation |
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203 | (1) |
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D The (Self-)Tied Hands of the EU Courts |
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204 | (1) |
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205 | (1) |
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IV Repercussions for the Meta-Theoretical Level: Is `New Governance' `Better Governance'? |
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206 | (1) |
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V Strengthening Regulatory Capacity: Proposals for Reform at the Micro Level |
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207 | (10) |
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A Impact Assessment Reloaded |
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207 | (1) |
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i Clarifying its Scope of Application |
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207 | (2) |
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ii The Operation of the Impact Assessment: Proportionate Level of Analysis or Carte Blanche! |
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209 | (1) |
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B Towards a Structured Proceduralisation in EU Agencies |
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210 | (1) |
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C Repoliticising a Depoliticised Political Debate |
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211 | (2) |
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D From Lapdog to Watchdog: The Catalyst Function of the EU Courts |
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213 | (2) |
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E Taking the EU Ombudsman Seriously |
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215 | (1) |
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F Fostering a Transparent Regulatory Process |
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216 | (1) |
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VI Three Facades of EU Risk Regulation |
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217 | (7) |
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A The Facade of Participation |
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218 | (2) |
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B The Facade of Scientific Truth |
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220 | (2) |
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C The Facade of Non-Bindingness |
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222 | (2) |
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224 | (1) |
Bibliography |
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225 | (18) |
Index |
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243 | |