The EU and Nanotechnologies: A Critical Analysis

by Tanja Ehnert

Overview

This book investigates the role of law in confronting major societal transformations embodied by the emergence of nanotechnologies. Taking the case of the European Union, it explores who the key decision-makers in the regulation of nanotechnologies are and how they take decisions. The questions are explored through two distinct case studies: the food and chemicals sectors. The book charts an incremental retreat of the European Union to its executive powers, including 'soft law' measures such as agencies' guidelines or implementing measures. This, the author argues, results in the Union's fundamental democratic control mechanisms, the EU legislature and the Court of Justice of the EU, being circumvented. The book recommends several immediate proposals to reform EU risk regulation, advocating a greater reliance on the European Parliament and outlining measures to increase the transparency of guidance drafting by EU agencies. This important work provides a timely examination of how emerging technologies pose both regulatory and democratic challenges.

Product Details

ISBN-13:	9781509935659
Publisher:	Bloomsbury Academic
Publication date:	12/26/2019
Series:	Modern Studies in European Law
Pages:	296
Product dimensions:	6.14(w) x 9.21(h) x 0.62(d)

About the Author

Tanja Ehnert is a legal officer at the EU Ombudsman.

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

Editorial Reviews

I recommend the book to academics in the fields of law and social sciences as well as to practitioners with an interest in EU's handling of new technologies and in EU policy design in general. Specifically, the book presents an abundant source of case material highlighting the desirability of a single legal framework for EU administrative procedure.
European Journal of Risk Regulation

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