Governing Nano Foods: Principles-Based Responsive Regulation

Food which nanotechnology has impacted or to which nanotechnology is applied is referred to as nanofood.  From treatment of the soil in which a crop plant is grown to the caring of a food, nanotechnology is a growing factor in the food supply. At this point, however, there is no definitive, effective global method for regulating the use of nanotechnology as it relates to the food suply.

Legislation on nanotechnologies is still evolving, as is understanding what data is needed for effective, efficient and appropriate risk assessment associated with nanotechnology impacted foods. Due to the emerging nature of nanotechnology and its role in the food supply, case-by-case studies are the current norm, but the need for wide-scale testing and broad-based regulatory standards is urgent.

This project is based on an EFFoST study designed to provide a comparative study of nanofood regulations in order to guide regulation development in this rapidly expanding market.

• Provides comparative study of nanofood regulations in order to guide regulation development in this rapidly expanding market
• Includes both case-by-case examples and more broad-based insights
• Provides models for regulation specifically for regulating nanotechnology as applied to food

Those working with nanotechnology as related to the production of food, those establishing policy and regulations

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

Conclusion

Appendix C. Lessons Learned from Selected Regulatory Reviews

Abstract

C.1 Introduction

C.2 Selected Reviews of Regulatory Actions on Nanotechnology and Food

Appendix D. Nanotechnology in Proposed and Upcoming Regulation

Abstract

D.1 Developments in the USA

D.2 Developments in the EU

D.3 Current Developments

Appendix E. Research Team

References

Sources of Law

Sources of Soft Law

Policy Documents

Private Standards

Literature

Miscealleanous

Glossary