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    Governing Nano Foods: Principles-Based Responsive Regulation: EFFoST Critical Reviews #3
    Governing Nano Foods: Principles-Based Responsive Regulation: EFFoST Critical Reviews #3
    Governing Nano Foods: Principles-Based Responsive Regulation: EFFoST Critical Reviews #3
    Ebook222 pages2 hours

    Governing Nano Foods: Principles-Based Responsive Regulation: EFFoST Critical Reviews #3

    By Bernd van der Meulen, Harry Bremmers, Kai Purnhagen and

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    About this ebook

    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
    LanguageEnglish
    PublisherAcademic Press
    Release dateJan 13, 2014
    ISBN9780124202146
    Governing Nano Foods: Principles-Based Responsive Regulation: EFFoST Critical Reviews #3
    Author

    Bernd van der Meulen

    Bernd van der Meulen (Bachelor/Masters of Law, Masters of Governance, PhD Law) is the head of the Law and Governance Group of Wageningen University, President & co-founder of the Dutch Food Law Association (NVLR) and Director of European Institute for Food Law where he is a supervisor of PhD-researchers and students in organisation, quality assessment, mediation and conflict resolution and served as chair of the exams committee of the Department of Social Sciences at Wageningen University (2002-2012)

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      Book preview

      Governing Nano Foods - Bernd van der Meulen

      Governing Nano Foods

      Principles-Based Responsive Regulation

      Bernd van der Meulen

      Harry Bremmers

      Kai Purnhagen

      Nidhi Gupta

      Hans Bouwmeester

      L. Leon Geyer

      EFFoST Critical Reviews #3

      Table of Contents

      Cover image

      Title page

      Copyright

      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

      Copyright

      Academic Press is an imprint of Elsevier

      32 Jamestown Road, London NW1 7BY, UK

      The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, UK

      Radarweg 29, PO Box 211, 1000 AE Amsterdam, The Netherlands

      225 Wyman Street, Waltham, MA 02451, USA

      525 B Street, Suite 1900, San Diego, CA 92101-4495, USA

      First published 2014

      Copyright © 2014 Elsevier Inc. All rights reserved.

      No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangement with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions.

      This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).

      Notices

      Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

      Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

      To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

      British Library Cataloguing in Publication Data

      A catalogue record for this book is available from the British Library

      Library of Congress Cataloging-in-Publication Data

      A catalog record for this book is available from the Library of Congress

      ISBN: 978-0-12-420156-9

      For information on all Academic Press publications visit our website at store.elsevier.com

      Preface and Acknowledgements

      Bernd van der Meulen

      Wageningen 15 October 2013

      This book is an updated and much revised version of a study that has been written to contribute to discussions at the FAO Round Table Sessions at NANOAGRI 2010 in São Pedro, Brazil.¹ UN Food and Agriculture Organization (FAO) requested the initial study. However, the analyses and opinions expressed are those of the authors. They do not necessarily reflect FAO’s positions. FAO holds the copyrights of the 2010 study, but authorised the authors to publish the information contained therein. This publication is endorsed by the European Federation of Food Science & Technology (EFFoST) and the Global Harmonization Initiative (GHI).

      This book primarily targets at an interdisciplinary audience. This is why the language and content of this book largely deviates from what an audience socialised in the respective science might expect from such a topic. We tried to strike a balance between presenting the core issues of the respective disciplines in a language understandable to an interdisciplinary audience on the one hand, while displaying the main topics from the respective disciplines related to the topic of the book in a most comprehensive way on the other. It will be on the reader to judge if we succeeded.

      We are grateful for the trust FAO has placed in the food law team at Wageningen University. The following experts have contributed in various ways to this study:

      Gerrit Alink (Wageningen University), Sourav Bhattacharjee (Wageningen University), Arnout Fisher (Wageningen University), Scott Geyer (Massachusetts Institute of Technology), Frans Kampers (Wageningen University), Maryvon Noordam (RIKILT Institute of Food Safety), Onno Omta (Wageningen University) and Merel van der Ploeg (Wageningen University). Other people who helped to make it possible to produce this study are Patrick van Veenendaal and Ingeborg Oude Lansink at the Liaison Office of Wageningen University.

      FAO has initiated development of a publication in collaboration with Monash University on Nanotechnology Applications in Food and Agricultural Sectors: Principles and Guidance for Food Safety Regulation. With the permission of FAO, parts of the text from this draft publication have been included in the appendix of this paper.

      ¹See and Caue Ribeiro et al., 2010. International Conference on Food and Agriculture Applications of Nanotechnologies, São Pedro.

      Executive Summary

      The objective of this book is to help to test and improve existing regulatory infrastructures – or if need be to build new ones – in such a way that they can ensure food safety in general in the face of the challenges posed by nanotechnologies.

      This book argues for a principles-based regulatory framework for nanotechnologies. In contrast to most conventional regulatory wisdom that identifies gaps in existing regulatory systems with a view of filling them with detailed rules specifically related to the risks emerging from nanotechnology,¹ this book subscribes to research on the ineffectiveness of such rule-based regulation. Instead, and in line with insights from research mainly from the sector of financial regulation,² we argue for a more responsive and thus effective principles-based framework to deal with nanotechnology in the food sector. Such a framework may provide an instrument to benchmark existing regimes and to design new or improved structures.

      This study builds on existing principles of food safety regulation and the interpretation of these principles at national and regional levels. The study works from the bottom-up to build a regulatory system for addressing the risks connected to nanotechnology applications in food production, despite the fact that profound knowledge on the impact of nanotechnologies is still lacking. The primary objective of the proposed regulatory system is to protect the health and safety of consumers of foods that are likely to contain substances obtained by nanoscale chemosynthesis or engineered nanoparticles. This relates not only to substances included in the food but also to substances that may leave traces in food due to their use at various stages of the food chain. Examples of such substances may be pesticides, equipment and packaging materials.

      There are existing and generally agreed principles on which regulatory approaches to food safety regulation are based. The proposed structure chooses responsibility including liability of food businesses as an underlying principle. Likewise, nanotechnologies applied to foods – nanomaterial in packaging or nanoproducts used in food preparation – may require appropriate safety studies. The core of nanofood safety regulation is a case-by-case premarket approval requirement for foods to which nanotechnologies have been applied. Where premarket approval is required, the sponsor of the product to which nanotechnology has been applied must provide methods of detection and scientific proof of safety of the product at issue. The scientific community and public authorities must develop and agree on methods of risk assessment. To ensure that this principle can be implemented in the context of problems stemming from the foods applications of nanotechnology, registration is desirable of at least all those businesses that bring such foods to the market. Furthermore businesses are required to have systems in place that enable the traceability of such foods. To protect property rights and enable food businesses to benefit from approved applications, applicants should enjoy an exclusive right for a certain period from the moment of approval on. After this exclusivity period, the approval should become generic to avoid obstruction of innovation and unnecessary suffering that may result from a repetition of safety testing on humans or animals.

      The leading risk assessment authorities and the international community are called upon to come to understandings regarding cooperation and mutual recognition that ensure world-wide market access for approved applications of nanotechnologies in the food sector and protect businesses from the need to submit to multiple approval procedures. Taken together the proposed measures constitute a regulatory framework capable of ensuring the safety of foods to which nanotechnology has been applied.

      ¹See Appendix C.

      ²See inter alia Julia Black, Martyn Hopper and Christa Band, 2007. Making a success of principles-based regulation. Law and Financial Markets Review, 191–206.

      Abbreviations

      ADI acceptable daily intake

      BSE bovine spongiform encephalopathy

      CAC Codex Alimentarius Commission (FAO/WHO)

      CCP critical control point

      CFR Code of Federal Regulations (USA)

      EFFL European Food and Feed Law Review

      EFSA European Food Safety Authority

      ENMs engineered nanomaterials

      ENPs engineered nanoparticles

      EPA Environmental Protection Agency (USA)

      EU European Union

      FAO Food and Agriculture Organization (UN)

      FCM

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