Governing Nano Foods: Principles-Based Responsive Regulation

Preface and Acknowledgements

Executive Summary

Abbreviations

Chapter 1. Introduction

1.1 Why Regulate the Application of Nanotechnologies in Food?

1.2 Applications of Nanotechnologies in Food and Agriculture

1.3 The Challenge to Regulate Nanotechnology in Food

1.4 Objectives, Methods and Scope of the Study

1.5 Structure of the Study

Chapter 2. Requirements for Food Safety Regulation

2.1 Introduction

2.2 Fundamental Principles of Food Safety Governance

2.3 Risk Analysis as a Method to Determine the Regulatory Outcome

2.4 Increasing Responsibility of Businesses (Private) Risk Assessors

2.5 Consequences for Regulation

Chapter 3. Safety Frame Applied to Food Applications of Nanotechnology

3.1 Introduction

3.2 Food Business

3.3 Food Products

3.4 Process

3.5 Communication

3.6 Food Contact Materials

3.7 Recommendation

Chapter 4. Case-by-Case Premarket Approval

4.1 Introduction

4.2 Object of Approval

4.3 Subject of Approval

4.4 Scope of Approval

4.5 Assessment

4.6 Generally Recognized as Safe

4.7 A Responsive System?

Chapter 5. Nano-Specific Regulation

5.1 Towards a Legal Concept

Chapter 6. Regulatory Burdens

6.1 Burdens

6.2 Other Concerns

6.3 Alleviating Burdens

6.4 Global Harmonisation?

Chapter 7. A Responsive Regulatory System

Chapter 8. Conclusions and Way Forward

8.1 Recommendations to Legislatures

8.2 Recommendation to the Scientific Community

8.3 Recommendation to International Risk Assessment Authorities

Appendix A. Analytical Framework

A.1 Elements of Food Safety Regulation

A.2 Requirements on Food Businesses

Appendix B. On the Delineation of the Concept ‘Nanotechnology’

Abstract