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EU and Nanotechnologies: A Critical Analysis [Kietas viršelis]

(EU Ombudsman, France)
  • Formatas: Hardback, 296 pages, aukštis x plotis: 234x156 mm, weight: 584 g
  • Serija: Modern Studies in European Law
  • Išleidimo metai: 10-Aug-2017
  • Leidėjas: Hart Publishing
  • ISBN-10: 1509908501
  • ISBN-13: 9781509908509
Kitos knygos pagal šią temą:
  • Formatas: Hardback, 296 pages, aukštis x plotis: 234x156 mm, weight: 584 g
  • Serija: Modern Studies in European Law
  • Išleidimo metai: 10-Aug-2017
  • Leidėjas: Hart Publishing
  • ISBN-10: 1509908501
  • ISBN-13: 9781509908509
Kitos knygos pagal šią temą:
This book investigates the role of law in confronting major societal transformations, namely globalisation and the emergence of nanotechnologies. Taking the case of the European Union, it explores who the key decision-makers in the field of nanotechnologies are and how they take decisions. Questions are explored through two distinct case studies: the food and chemicals sectors. The incremental retreat of the European Union to its executive powers, including 'soft law' measures such as agencies' guidelines or comitology measures, is charted. This, the author argues, results in the Union's fundamental democratic control mechanisms-the EU legislature and the Court of Justice-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. Based on a revised Phd thesis. (Series: Modern Studies in European Law) [ Subject: Information Technology Law, EU Law]

Recenzijos

I recommend the book to academics in the fields of law and social sciences as well as to practitioners with an interest in EUs 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. -- Professor Stephan Meyer * European Journal of Risk Regulation *

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