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Overview
Product Details
ISBN-13: | 9781509908509 |
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Publisher: | Bloomsbury Academic |
Publication date: | 08/10/2017 |
Series: | Modern Studies in European Law , #75 |
Edition description: | Critical |
Pages: | 296 |
Product dimensions: | 6.14(w) x 9.21(h) x 0.69(d) |
About the Author
Table of Contents
Acknowledgements v
Table of Cases xiii
Table of Legislation xvii
Introduction: Regulating the Invisible xxix
1 Setting the Scene: Nanotechnologies and their Regulation at the EU Level 1
I What are Nanotechnologies? 1
II Between Nanomania and Nanophobia 3
III Risk as a Rationale for Regulatory Intervention 5
IV The EU's Approach to the Regulation of Nanotechnologies: A Bird's Eye Perspective 7
A The EU's Incremental Approach to Nanotechnologies 7
B The Legislative Review 9
C Complementary Elements 11
V Conclusion 12
2 Regulating in Today's Nano Society 14
I Embedding the Regulation of Nanotechnologies in Its Societal Context 14
A Globalisation 15
B Functional Differentiation 16
C The Rise of the Risk Society 17
D Through the Lenses of Nanotechnologies 19
II Regulating in Today's Nano Society: Two Theoretical Accounts 20
A A Deliberative Account 20
B A Reflexive Account 23
C Grasping the 'Procedural Turn' 26
III Translating the Debate to the EU Level 27
A The Rise of 'New Modes of Governance' 28
i The White Paper on European Governance 30
ii The Concept of 'New (Modes of) Governance' 31
B The Rise of European Risk Regulation 33
i Risk Analysis 35
ii Precaution 36
IV Conclusion and Next Steps 38
3 Analysing EU (Risk) Regulation through the Lenses of Regulatory Capacity 40
I Denning the Object of Analysis: 'EU Regulation' 40
A Excursus: Law, Regulation and Governance 40
B Defining 'Regulation' 44
C The Regulatory Spectrum at the EU Level 45
i Public-Private 45
ii Legal Effect 46
D The Object of Analysis: 'EU Regulation' 49
II Putting on the Analytical Lenses of Regulatory Capacity 49
A First Element: Pooling Knowledge 50
i Defining 'Knowledge' 50
ii The Impact Assessment as a Procedure to Pool Knowledge 51
iii Extending the Impact Assessment Procedure to Parliament and Council 55
B Second Element: Ensuring Legitimate Regulation 57
i Defining 'Legitimacy' 57
ii Participation at the EU Level 59
iii Holding the EU Regulator to Account 64
III Conclusion 70
4 Nanotechnologies in Food 72
I Nanotechnologies in Food 72
A Innovating Food Production and Processing 72
B Applications of Nanotechnologies in Food 73
i Nanomania: Exploiting Nanotechnologies for the Food Sector 74
ii Nanophobia: Environmental, Health and Safety Risks of Nanofoods 75
C The EU Food Industry and Nanotechnologies 76
II The EU Regulatory Framework for Nanotechnologies in Food 77
A EU Legislative Framework for Food: Fit for Nano? 77
i The General Food Law 78
ii Specific EU Food Law 79
iii State of Play: A Cautious European Commission 85
B Addressing Nanotechnologies via the Executive Route 86
i Via Comitology: Implementing Acts under the FCM Regulation 87
ii Via Agency Guidance Documents: EFSA's Guidance on Risk Assessment of Nanotechnologies in Food and Feed 88
iii Via Commission Recommendations: Defining the Term 'Nanomaterial' 89
iv Synthesis: Towards Executive Rule Making 93
III Analysing the EU's Regulation of Nanofoods through the Lenses of Regulatory Capacity 94
A Pooling Knowledge 94
i The Impact Assessment: A Tool to Pool Knowledge? 95
ii Knowledge Collection through Commission Expert Groups 99
iii Knowledge Collection in the Drafting of EFSA's Guidance Document 101
iv Synthesis: Pooling Knowledge in the Drafting of a Regulatory Framework for Nanotechnologies in Food 103
B Participation 106
i Political Participation 107
ii Administrative Participation 108
iii Synthesis: Participation in Nano Practice 117
C Accountability 118
i Political Accountability vis-à-vis the European Parliament 118
ii Legal Accountability: The Role of the EU Courts 123
iii Administrative Accountability: Making Way for the EU Ombudsman 133
iv Social Accountability: A Transparent Regulatory Process? 136
v Synthesis: Holding the EU Regulator to Account 140
IV Conclusion 141
5 Nanotechnologies in Chemicals 144
I Nanotechnologies in Chemicals 144
A Innovating Chemicals 144
B Applications of Nanotechnologies in the Chemicals Sector 145
i Nanomania 146
ii Nanophobia 147
C The EU Chemicals Sector and Nanotechnologies 148
II The EU Regulatory Framework for Nanotechnologies in Chemicals 148
A Reforming the EU Chemicals Policy 148
i REACH and Its Main Pillars 150
ii REACH and Nano 154
iii Revising REACH? No But Yes 158
B Addressing Nanotechnologies via Comitology 160
C Addressing Nanotechnologies via ECHA Guidance Documents 160
i ECHA Guidance on Information Requirements and Chemical Safety Assessment 162
ii ECHA Guidance on Nanomaterials in IUCLID 5 164
D The State of Play: Spotlight on the EU Executive 165
III Analysing the EU's Regulation of Nanochemicals through the Lenses of Regulatory Capacity 166
A Pooling Knowledge 167
i Pooling Knowledge in the Drafting of the REACH Implementing Act(s) 167
ii Pooling Knowledge in the Drafting of ECHA's Guidance Documents 170
iii Synthesis: Pooling Knowledge 179
B Participation 180
i Participation in the Drafting of REACH'S Implementing Act(s) 181
ii Participation in the Drafting of ECHA's Guidance Documents 184
ii Synthesis: From Parliamentary Absence and a Cosy Stakeholder Collaboration 188
C Accountability 190
i The Parliament's ex post Scrutiny of ECHA's Guidance Documents 190
ii In Legal Twilight: The Role of the EU Courts 191
iii Administrative Accountability: The Expandable Role of the European Ombudsman 193
iv Social Accountability: Transparency on Paper 194
v Synthesis: Holding ECHA to Account 196
IV Conclusion 197
6 Conclusion 199
I Regulating in Today's Nano Society: The Point of Departure 199
II Spotlight on the EU Executive 200
III Main Findings of the Critical Analysis or the Pitfalls of 'New Governance' 201
A The Impact Assessment: Between Empty Proceduralisation and Strategic Choice 201
B The Fragmentary Proceduralisation of EU Agency Rule Making 202
C Depoliticisation: Towards Technocratic Rule? 203
i The Lack of Parliamentary Involvement 203
ii The Spectacle of Administrative Participation 203
D The (Self-)Tied Hands of the EU Courts 204
E (In)transparency 205
IV Repercussions for the Meta-Theoretical Level: Is 'New Governance' 'Better Governance'? 206
V Strengthening Regulatory Capacity: Proposals for Reform at the Micro Level 207
A Impact Assessment Reloaded 207
i Clarifying its Scope of Application 207
ii The Operation of the Impact Assessment: Proportionate Level of Analysis or Carte Blanche? 209
B Towards a Structured Proceduralisation in EU Agencies 210
C Repoliticising a Depoliticised Political Debate 211
D From Lapdog to Watchdog: The Catalyst Function of the EU Courts 213
E Taking the EU Ombudsman Seriously 215
F Fostering a Transparent Regulatory Process 216
VI Three Facades of EU Risk Regulation 217
A The Facade of Participation 218
B The Facade of Scientific Truth 220
C The Facade of Non-Bindingness 222
VII Outlook 224
Bibliography 225
Index 243