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Beschreibung

Food is produced not only to be consumed in the country of its origin, but also to be exported to various locations worldwide. As such, manufacturers and suppliers need to know the market conditions and regulations of their customers in export markets.

Filling a distinct need in the globalized food economy, this introductory reference distils the key facts and regulations from the food laws of 10 countries and the European Union across four continents. The result is a truly global survey of the world's most important food markets in terms of regulatory standards, principles and the authorities involved.

To enable comparison between each country portrait, each chapter is structured in the same way, and includes information on the legal framework, the competent authorities, explanations of the basic principles of food law, introductions to the main areas of regulation (particularly, labeling and advertising; food hygiene and safety; additives and flavorings; food supplements; genetically modified organisms; import and export regulations), accountability regulations, and information on Internet resources.

The publication therefore provides key facts for food producers active on the international market, who often lack the time and resources to refer to the primary laws and legal commentaries.

Markets discussed:

  • Argentina
  • Brazil
  • Canada
  • China
  • European Union
  • Japan
  • USA
  • Republic of Korea
  • Russian Federation
  • Switzerland
  • Turkey

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Veröffentlichungsjahr: 2014

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Table of Contents

Cover

Related Titles

Title Page

Copyright

Abbreviated Table of Contents

Preface

Notes on Contributors

Chapter 1: Argentina

1.1 Legal Framework

1.2 Food Safety Authorities and Enforcement Procedures

1.3 Basic Principles of Food Law

1.4 Overview of Selected Regulation Areas

1.5 Accountability Regulations

1.6 Current Topics – Special Topics and Challenges

Appendix 1.A: Internet Sources

Appendix 1.B: Abbreviations

Chapter 2: Brazil

2.1 Introduction

2.2 Legal Framework

2.3 Food Safety Authorities and Enforcement Procedures

2.4 Basic Principles of Food Law

2.5 Overview on Selected Regulation Areas

2.6 Accountability Regulations

2.7 Current Topics

Appendix 2.A: Internet Sources

Appendix 2.B: Abbreviations

Chapter 3: Canada

3.1 Legal Framework

3.2 Key Food Safety Authorities and Enforcement Procedures

3.3 Basic Principles of Food Law

3.4 Overview of Selected Areas of Regulation

3.5 Liability

3.6 Current Topics

Appendix 3.A: Internet Sources

Appendix 3.B: Abbreviations

Chapter 4: China

4.1 Evolution of Food Safety Law and Current Legal Framework

4.2 Food Safety Authorities and Enforcement Procedures

4.3 Main Systems of Food Law

4.4 Overview on Selected Regulation Areas

4.5 Accountability Regulations

4.6 Current Topics and Challenges

4.7 Conclusions

Appendix 4.A: Internet Sources

Appendix 4.B: Abbreviations

Chapter 5: European Union*

5.1 Legal Framework

5.2 Food Safety Authorities and Enforcement Procedures

5.3 Basic Principles of Food Law

5.4 Overview on Selected Regulation Areas

5.5 Accountability Regulations

5.6 Current Topics

Appendix 5.A: Internet Sources

Appendix 5.B: Abbreviations

Chapter 6: Japan

6.1 Legal Framework

6.2 Food Authorities

6.3 Basic Principles of Food Law

6.4 Overview on Selected Regulation Areas

6.5 Accountability Regulations

6.6 Current Topics

Appendix 6.A: Internet Sources

Appendix 6.B: Abbreviations

Chapter 7: Republic of Korea

7.1 Legal Framework

7.2 Food Safety Authorities and Enforcement Procedures

7.3 Basic Principles of Food Law

7.4 Overview on Selected Regulation Areas

7.5 Accountability Regulations

7.6 Current Topics

Appendix 7.A: Internet Sources

Appendix 7.B: Abbreviations

Chapter 8: Russian Federation

8.1 Legal Framework

8.2 Food Safety Authorities

8.3 Basic Principles of Food Law

8.4 Overview on Selected Regulation Areas

8.5 Accountability Regulations

8.6 Current Topics

Appendix 8.A: Internet Sources

Appendix 8.B: Abbreviations

Chapter 9: Switzerland

9.1 Legal Framework

9.2 Food Safety Authorities and Enforcement Procedures

9.3 Basic Principles of Food Law

9.4 Overview on Selected Regulation Areas

9.5 Accountability, Liability, and Criminal Law Provisions

9.6 Current Topics

Acknowledgment

Appendix 9.A: Internet Sources

Appendix 9.B: Abbreviations

Chapter 10: Turkey

10.1 Legal Framework

10.2 Food Safety Authorities and Enforcement Procedures

10.3 Basic Principles of Food Law

10.4 Overview on Selected Regulation Areas

10.5 Accountability Regulations

10.6 Current Topics

Appendix 10.A: Internet Sources

Appendix 10.B: Abbreviations

Chapter 11: United States of America

11.1 Legal Framework

11.2 Food Safety Authorities and Enforcement Procedures

11.3 Basic Principles of Food Law

11.4 Overview of Selected Regulation Areas

11.5 Accountability Regulations

11.6 Current Topic: FSMA Implementation

Appendix 11.A: Internet Sources

Appendix 11.B: Abbreviations

Index

End User License Agreement

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Guide

Cover

Table of Contents

Preface

Chapter 1: Argentina

List of Illustrations

Figure 1.1

Figure 1.2

Figure 1.3

Figure 1.4

Figure 7.1

Figure 7.2

Figure 7.3

Figure 7.4

Figure 10.1

List of Tables

Table 1.1

Table 1.2

Table 1.3

Table 1.4

Table 1.5

Table 2.1

Table 2.2

Related Titles

Brennan, J.G., Grandison, A.S. (eds.)

Food Processing Handbook

Second Edition

2012

ISBN: 978-3-527-32468-2

(Also available in electronic formats)

Rijk, R., Veraart, R. (eds.)

Global Legislation for Food Packaging Materials

2010

ISBN: 978-3-527-31912-1

(Also available in electronic formats)

Bertheau, Y. (ed.)

Genetically Modified and Non-Genetically Modified Food Supply Chains – Co-Existence and Traceability

2013

ISBN: 978-1-444-33778-5

(Also available in electronic formats)

Salminen, S., Kneifel, W. (eds.)

Probiotics and Health Claims

2011

ISBN: 978-1-405-19491-4

(Also available in electronic formats)

Forsythe, S.

The Microbiology of Safe Food 2e

Second Edition

2010

Print ISBN: 978-1-405-14005-8

(Also available in electronic formats)

Adobe PDF ISBN: 978-1-118-68569-

ePub ISBN: 978-1-444-35966-

eMobi ISBN: 978-1-444-35967-1

Global Food Legislation

An Overview

Edited by

Evelyn Kirchsteiger-Meier and Tobias Baumgartner

The Editors

Evelyn Kirchsteiger-Meier

ZHAW Zurich University of Applied\hb Sciences

Institute of Food and Beverage Innovation

Centre for Quality Management and Food Law

Campus Reidbach

8820 Wädenswil

Switzerland

Dr. Tobias Baumgartner

Europa Institute at the University of Zurich

Hirschengraben 56

8001 Zurich

Switzerland

All books published by Wiley-VCH are carefully produced. Nevertheless, authors, editors, and publisher do not warrant the information contained in these books, including this book, to be free of errors. Readers are advised to keep in mind that statements, data, illustrations, procedural details or other items may inadvertently be inaccurate.

Library of Congress Card No.: applied for

British Library Cataloguing-in-Publication Data

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

Bibliographic information published by the Deutsche Nationalbibliothek

The Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed bibliographic data are available on the Internet at <http://dnb.d-nb.de>.

© 2014 Wiley-VCH Verlag GmbH & Co. KGaA, Boschstr. 12, 69469 Weinheim, Germany

All rights reserved (including those of translation into other languages). No part of this book may be reproduced in any form – by photoprinting, microfilm, or any other means – nor transmitted or translated into a machine language without written permission from the publishers. Registered names, trademarks, etc. used in this book, even when not specifically marked as such, are not to be considered unprotected by law.

Print ISBN: 978-3-527-33555-8

ePDF ISBN: 978-3-527-68080-1

ePub ISBN: 978-3-527-68081-8

Mobi ISBN: 978-3-527-68082-5

oBook ISBN: 978-3-527-68079-5

Abbreviated Table of Contents

1 Argentina

Alejandro Ariosti and Margarita Olivera Carrión

2 Brazil

Anneliese Moritz and Christian Moritz

3 Canada

John F. Blakney, Margot E. Patterson, Olivia Wright, and Jawaid Panjwani

4 China

Yongmin Bian

5 European Union

Tobias Baumgartner and Wesselina Uebe

6 Japan

Moritz Bälz and Gabriele Koziol

7 Republic of Korea

Tom Pinansky, Ki Tai Park, April Kim, and Jin Hyuk Choi

8 Russian Federation

Andreas Knaul and Oleg Zhabinski

9 Switzerland

Evelyn Kirchsteiger-Meier

10 Turkey

Petek Ataman and Samim Saner

11 United States of America

Gary Jay Kushner, Maile Gradison Hermida, and Brian D. Eyink

Preface

The phenomenon of globalization, which we are currently experiencing, significantly affects our eating habits along with many other aspects of our lives. An enormous range of foodstuffs from around the world is now available due largely to the increase in global trade. The demand for foodstuffs from other cultures has steadily increased over recent decades, and as a consequence food import and export infrastructures have now developed globally. However, global harmonization of food legislation has not been as comprehensive: the Codex Alimentarius, a collection of standards, guidelines, codes of practice, and advisory texts on food safety and quality, has been published by the UN Food and Agriculture Organization and the World Health Organization since 1963. In total, 185 Member Countries and the European Union are members of the Codex Alimentarius Commission. In addition to general rules about labeling, hygiene, and residues, the Codex Alimentarius includes product-specific regulations; however, the Codex Alimentarius does not cover all the relevant areas in food legislation. Furthermore, the provisions of the Codex Alimentarius are not mandatory, but are intended as recommendations to Member States for adoption into national law. Although in practice the reference standards have proven to be of great significance and value, they could not provide for the unification of global food legislation.

At a regional level, the regulations of the European Union (EU) ensure a high level of harmonization of the food legislation of Member States and also contribute, through the EU's contractual relations with third countries (e.g., Switzerland), to an increasing harmonization of food law. In addition, common trade agreements such as the Mercosur (“Common Market of the South”) in South America further facilitate the partial harmonization of food legislation. Globally, however, important differences in legislation remain, including those relating to labeling of foodstuffs, traceability systems in food production, and the use of genetic engineering in food production.

Against this background, the objective of this publication is to provide a concise overview of the food legislation in various countries. The selection of contributions for this first edition is based on the countries of the G-20, and includes Argentina, Brazil, Canada, China, the European Union, Japan, the Republic of Korea, the Russian Federation, Switzerland, Turkey, and the United States of America. The individual contributions provide an introduction and a basic orientation enabling the reader to undertake further research. Although the original documents, in particular the legal texts, are only available in the native language in many countries, this publication provides a single point of reference in English. To enable comparison between each country overview, each chapter is structured in the same way, and includes, in particular, information on the legal framework, the competent authorities, explanations of the basic principles of food law, introductions to the main areas of regulation, accountability regulations, in addition to references to further sources of information on the Internet.

This publication has been compiled primarily for the food industry, food trade associations, and the competent authorities. However, the information presented is also likely to be of value to readers in the academic environment, providing a foundation for further research on the standardization and optimization of the regulatory environment associated with the global trade in foodstuffs.

The initiative for this publication resulted from a collaboration between the Editors in designing and executing a training program on the food legislation of Switzerland and the European Union, which has been run annually since 2009. During this course, the need for information on the international regulatory environment covering food import and export was identified, and we hope through this publication to have fulfilled this need. The Editors are grateful for any suggestions and comments that can be incorporated into future editions. We would like to express our thanks to all the authors and the publisher, WILEY, for their outstanding cooperation.

This edition represents the status as of Fall 2013.

Tobias Baumgartner

Europa Institute at the University of Zurich

Evelyn Kirchsteiger-Meier

Zurich University of Applied Sciences (ZHAW)

Notes on Contributors

Alejandro Ariosti

Professor Alejandro Ariosti is a Chemical Engineer and Master of Food Science and Technology, with a Post-degree in Plastics Processing Technologies. Since 1984, he has worked on food packaging at the Plastics Centre – National Institute of Industrial Technology (INTI), having been its Director during 2002–2007. He is Food Packaging Professor at the University of Buenos Aires (Faculty of Pharmacy and Biochemistry), at other universities, and at the Argentine Packaging Institute. He represents the INTI at the Mercosur Packaging Group–Food Commission since 1991, and at the Argentine Standardization and Certification Institute; and the GHI (Global Harmonization Initiative, based in Vienna) in Argentina. He has been a Researcher and National Coordinator of the Iberoamerican CYTED (“Science and Technology for Development”) Program on Food Packaging Projects. He has specialized in evaluating recycled food-grade plastics technologies, in developing food packaging standards and regulations for South American countries, and in training Latin American industry professionals and government officials. He lectures frequently in Latin America, Europe, and the United States.

Instituto Nacional de Tecnología Industrial

Centro de Investigación y Desarrollo Tecnológico para la Industria Plástica

Parque Tecnológico Miguelete

Colectora de Avenida General Paz 5445

1650 San Martín

Provincia de Buenos Aires

Argentina

[email protected]

Petek Ataman

Petek Ataman is a Food Engineer and graduated from Hacettepe University, Turkey. She worked for several years in different establishments both in private and state economic enterprises. She worked at the Ministry of Agriculture and Rural Affairs (MARA) from 1995 to 2008 and is now working as a freelancer. She teaches courses on Food Legislation and Food Labeling Legislation in different organizations. She also gives lectures on Food Legislation at the Near East University, Turkish Republic of Northern Cyprus. She has published a number of articles on Food Safety Management Systems and Food Policies in national journals and sectoral periodicals. She is one of the Founding Members of The Chamber of Food Engineers which is working under the Union of Chambers of Turkish Engineers and Architects. She is the Chairman of the Executive Board of the Chamber of Food Engineers.

Gida Mühendisleri Odasi

Merutiyet Caddesi, 22/13

06440 Kizilay

Ankara

Turkey

[email protected]

Moritz Bälz

Professor Dr. Moritz Bälz, LLM (Harvard) holds the Chair of Japanese Law and its Cultural Foundations at Goethe University Frankfurt. His research focuses on Japanese business law from a comparative perspective as well as on issues of dispute resolution in Japan. He is a Co-editor of Handbuch Japanisches Handels- und Wirtschaftsrecht (Heymanns Cologne, 2011) as well as Business Law in Japan – Cases and Materials (Wolters Kluwer, 2012). He serves as a Co-editor of Zeitschrift für Japanisches Recht Journal of Japanese Law. Prior to his appointment as Professor of Law he had been working with the international law firm Freshfields Bruckhaus Deringer in New York and Frankfurt for several years.

Goethe University Frankfurt

Faculty of Law/Interdisciplinary Centre for East Asian Studies (IZO)

Grüneburgplatz 1

60323 Frankfurt am Main

Germany

[email protected]

Tobias Baumgartner

Dr. Tobias Baumgartner, LLM (Eur.) is Vice Director of the Europe Institute at the University of Zurich (EIZ). He studied law at the Universities of Frankfurt and Mainz, obtained a Master's degree (LLM) in European and International Law from the University of Bremen, and a Doctoral degree (Dr. iur.) from the University of Zurich. He gained work/research experience in Hamburg, Hong Kong, and New York. His fields of expertise cover the areas of EU constitutional law, EU business law, intellectual property law and food law. In his position at the EIZ, he advised the Federal Office of Public Health in the field of EU food law. Furthermore, he is a lecturer in an Advanced Study Program on Swiss and EU food law, which he has established in cooperation with Evelyn Kirchsteiger-Meier from the Zurich University of Applied Sciences (ZHAW).

Europa Institute at the University of Zurich

Hirschengraben 56

8001 Zürich

Switzerland

[email protected]

Yongmin Bian

Professor Dr. Yongmin Bian is a Professor of the Law School, University of International Business and Economics and Research Fellow of the Center for International Sustainable Development Law (Canada). She obtained her BA and MA from China University of Political Science and Law in Beijing, her PhD in Law from the University of International Business and Economics as well as Postgraduate Diploma of International Law and Organizations for Development from Erasmus University. She was a Visiting Fellow at the Lauterpacht Centre for International Law, Cambridge. Her research interests include Public International Law, International Environmental Law, International Trade Law, and Food Safety Law.

University of International Business and Economics

School of Law

Huixinli Dong Street

Chaoyang District

Beijing

P.R. China

[email protected]

John F. Blakney

John Blakney's practice focuses on administrative law and federal and provincial regulation of business, including pricing, advertising, and marketing practices, product approval, design, product safety, and related international trade matters, with an emphasis on health and consumer products and services. He regularly advises clients on food, drug, and other health product approvals, including drug and natural health product registrations, and amendments thereto. He also provides advice to consumer product suppliers on regulated product marketing practices, pricing, advertising, packaging, labeling, and promotion, as well on downstream arrangements with major retailers. He is Co-Instructor of the Canadian Food Regulation Course at Michigan State University.

Dentons Canada LLP

99 Bank Street

Suite 1420

Ottawa, ON K1P 1H4

Canada

[email protected]

Jin Hyuk Choi

Jin Hyuk Choi is an associate in the corporate department of Barun Law. He graduated from the Korea Advanced Institute of Science and Technology (KAIST) with a BS as well as a MS in Computer Science and holds a Juris Doctor degree from Kyunghee University Law School. He is a member of the Korean Bar Association. He had extensive business experience prior to getting his law degree.

Barun Law LLC

Barun Law Building

92 gil 7, Teheran-ro, Gangnam-gu

Seoul 135-846

Republic of Korea

[email protected]

Brian D. Eyink

Brian D. Eyink practices in the area of food and agriculture law. He represents clients regulated by the Food and Drug Administration (FDA), Department of Agriculture, the Federal Trade Commission, and other health and safety organizations at both the federal and state level. His experience includes advising clients with regard to United States Department of Agriculture (USDA) and FDA enforcement actions, federal investigations, regulatory compliance, litigation support, comment preparation, legislative drafting, advertising disputes, and labeling issues. Prior to joining Hogan Lovells, he served as a Judicial Law Clerk to the Honorable Gerald Bard Tjoflat of the US Court of Appeals for the Eleventh Circuit. While in law school, Brian served as an Executive Editor of the Duke Law Journal.

Hogan Lovells US LLP

Columbia Square

555 Thirteenth Street, NW

Washington, DC 20004

USA

[email protected]

Maile Gradison Hermida

Maile Gradison Hermida practices with Hogan Lovells in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations. She advises clients on the development of label claims, web site and promotional campaigns for products, as well as the various requirements applicable to the labeling of foods. She also provides assistance to trade associations and food companies with fashioning comments and developing strategies in response to agency rulemakings and other public policy issues. Prior to joining Hogan & Hartson, she served as a Judicial Clerk to the Honorable Charles F. Lettow of the US Court of Federal Claims. She graduated with high honors from The George Washington University Law School, where she served as Executive Editor of The George Washington Law Review.

Hogan Lovells US LLP

Columbia Square

555 Thirteenth Street, NW

Washington, DC 20004

USA

[email protected]

April Kim

April Kim is a Foreign Attorney at Barun Law with bar memberships in California and Nevada. She graduated from Cornell University in 2007 with a BA in English and received her Juris Doctor in 2011 from Fordham Law School where she was a New York City Bar Association Fellow. She is a US citizen who received all of her formal education in the United States. Prior to joining Barun Law in early 2013, she worked as a corporate associate in Southern California. She currently assists clients in cross-border corporate matters.

Barun Law LLC

Barun Law Building

92 gil 7, Teheran-ro, Gangnam-gu

Seoul 135-846

Republic of Korea

[email protected]

Evelyn Kirchsteiger-Meier

Evelyn Kirchsteiger-Meier is a Senior Lecturer and Head of the Centre for Quality Management (QM) and Food Law at the Zurich University of Applied Sciences (ZHAW). She holds a Master's degree in Biology and Chemistry from the University of Basel, Switzerland. Before joining the ZHAW, she gained extensive experience in industry from working for Nestlé, the Swiss-based multinational food and beverage company, for 11 years, as QM/food safety manager. Since 2008, she has lectured in food law, food safety, and quality management at both Bachelor and Master levels, and has taught numerous adult eduction programs. She also leads several projects in the field of food law and food safety in collaboration with external partners and institutions. Furthermore, she organizes and chairs an annual conference in food law that has gained a prominent position within the food industry and the competent authorities in Switzerland, and regularly publishes on the subject of food law.

ZHAW Zurich University of Applied Sciences

Institute of Food and Beverage Innovation

Centre for Quality Management and Food Law

Campus Reidbach

8820 Wädenswil

Switzerland

[email protected]

Andreas Knaul

Dr. Andreas Knaul studied Law and Political Science in Germany, France, and the United States, and since 1987 has been working as attorney at law. Since 1993, he has been professionally active in the field of legal and tax consulting in the Russian Federation, currently as Managing Partner in Moscow and in Kazakhstan of Rödl & Partner. He disposes of a profound legal and country knowledge, and has over 20 years of experience in the field of European and International Business Law with a country emphasis on Russia, Ukraine, and Kazakhstan. His practice is focused on corporate law, mergers and acquisitions, and antitrust, providing qualified support for foreign enterprises in entering into and operating in the Russian Federation and other Commonwealth of Independent States countries.

Röedel & Partner

Elektrosawodskaja ul. 27

107023 Moscow

Russian Federation

[email protected]

Gabriele Koziol

Dr. Gabriele Koziol is Associate Professor at the University of Kyoto. She studied law and translation studies (English, Japanese) at the University of Vienna and the University of Sheffield, and obtained a Dr. iur. from the University of Regensburg with a thesis on “Security interests in intellectual property licences.” Her research interest lies in the field of private law and intellectual property law, and in particular comparative research on German, Austrian, and Japanese law.

University of Kyoto

Graduate School of Law

Yoshida Honmachi, Sakyo-ku

606-8501 Kyoto

Japan

[email protected]

Gary Jay Kushner

Gary Jay Kushner has been a food industry lawyer for more than 35 years. He represents trade associations and corporations before government agencies, Congressional committees, and the courts in a variety of matters. He has particular experience with the development, interpretation, and enforcement of laws and regulations governing food production, processing, and distribution throughout the United States and internationally. Before joining Hogan & Hartson, he served as Vice President and General Counsel for the American Meat Institute where he directed the organizations legal, regulatory, and legislative activities. Before first entering the private practice of law, he served as Staff Counsel for Scientific Affairs at the Grocery Manufacturers of America. He began his legal career as a Law Clerk to The Honorable John R. Hess in the Superior Court for the District of Columbia. He is a frequent lecturer and regularly contributes to numerous trade publications. He graduated from the University of Michigan and Georgetown University Law Center.

Hogan Lovells US LLP

Columbia Square

555 Thirteenth Street, NW

Washington, DC 20004

USA

[email protected]

Anneliese Moritz

Anneliese Moritz has been admitted to the Paris (2005) and São Paulo (2011) Bar, and is thus fully licensed to practice law under French and Brazilian jurisdiction. During her stays in Brazil, Germany, and France she followed an international legal education, including a Master's in European Community Law (Strasbourg Université Robert Schuman in 2003). Given those cross-cutting competences, she runs the French Desk of the Brazilian law firm Felsberg e Associados. In this capacity, she focuses on all questions regarding foreign direct investments in Brazil, including corporate and commercial matters as well as administrative aspects, such as the complex regulatory framework of Brazilian food law.

Felsberg e Associados – Advogados e Consultores Legais

Avenida Paulista 1294

Sao Paulo, SP

CEP 01310-915

Brazil

[email protected]

Christian Moritz

Christian Moritz is a German lawyer based in São Paulo, Brazil, and Düsseldorf, Germany, and Head of the German Desk of the Brazilian law firm Felsberg e Associados. He has an academic background in law from the Universities of Bonn, Germany, as well as Strasburg and Montpellier, France. In view of the strong presence of German companies, many of them belonging to the agricultural and food processing sector, acting in Brazil, he gained extensive experience in associated legal affairs. In addition to the regulatory-related work, since 2007 he has assisted foreign investors in establishing, buying, selling, and restructuring their Brazilian operations, shaping transnational employment and service agreements as well as distribution frameworks.

Felsberg e Associados – Advogados e Consultores Legais

Avenida Paulista 1294

Sao Paulo, SP

CEP 01310-915

Brazil

[email protected]

Margarita Olivera Carrión

Professor Dr. Margarita Olivera Carrión is Professor at the Department of Food Science, Coordinator of the Career of Food Science and Technology, and Head Professor of the Professional Practices and Food Law at the Faculty of Pharmacy and Biochemistry, University of Buenos Aires. She studied food sciences at the Faculty of Exact and Natural Sciences – University of Buenos Aires, and obtained her PhD degree in the field of Food Chemistry at the same University. She is Director and Professor at both Master and PhD levels in national and private universities as well as in several institutions. She lectures extensively on functional foods, food law and nutritional labeling. During 2005–2007, she was President of the Argentine Association of Food Technologists, representative in Argentina of the Institute of Food Technology and of the International Union of Food Science and Technology.

Cátedra de Bromatología

Facultad de Farmacia y Bioquímica

Universidad de Buenos Aires

Junín 956 2o. Piso

1113 Buenos Aires

Argentina

[email protected]

Jawaid Panjwani

Jawaid Panjwani is an Associate in the Ottawa office of Dentons Canada LLP, and practices regulatory and corporate law. In his regulatory practice, he assists and advises clients in a number of areas including consumer product regulation, international trade and investment, telecommunications and broadcasting, digital media, privacy, and government relations. He holds a law degree from Osgoode Hall Law School in Toronto and a Master's degree in International Affairs from Carleton University in Ottawa.

Dentons Canada LLP

99 Bank Street

Suite 1420

Ottawa, ON K1P 1H4

Canada

[email protected]

Ki Tai Park

Mr. Ki Tai Park is a Partner in the Corporate Department of Barun Law. He graduated from Seoul National University with an LLB and holds an LLM from Columbia University School of Law in New York. He is a Member of the Seoul Bar Association and the New York Bar Association. He also serves as a Lecturer at the Judicial Research and Training Institute of Korea, an Advisor to the Seoul Metropolitan Government, and a Member of the Policy Advisory Committee of the Ministry of Foreign Affairs and Trade. He served as an Outside Director on the board of Hyundai Heavy Industries Co., Ltd. from 2003 to 2005. He has written extensively on Korean commercial law and the laws governing foreign investment in Korea.

Barun Law LLC

Barun Law Building

92 gil 7, Teheran-ro, Gangnam-gu

Seoul 135-846

Republic of Korea

[email protected]

Margot E. Patterson

Margot E. Patterson is Counsel in the Regulatory Group of the Ottawa Office of Dentons Canada LLP. She advises businesses throughout the consumer product distribution chain concerning product regulation, advertising and marketing, and product safety issues. She deals regularly with federal and provincial government agencies on behalf of manufacturers, distributors, and retailers with respect to licensing, reporting, recall, and general compliance matters. She also provides advertising and marketing advice, notably with respect to food and alcohol advertising and promotions. Prior to joining Dentons, she was General Counsel for a national industry association, with responsibility for regulatory law and related government relations initiatives. She holds a law degree from McGill University in Montreal and a Master's degree in Public Administration with a focus on industry regulation from Queen's University in Kingston.

Dentons Canada LLP

99 Bank Street, Suite 1420

Ottawa, ON K1P 1H4

Canada

[email protected]

Tom Pinansky

Tom Pinansky is a US attorney (member of the bars of Washington, DC and Texas) and a Senior Foreign Attorney (Partner) at Barun Law. He graduated from Harvard College (magna cum laude) and the University of Pennsylvania Law School. He is a US citizen, and has been deeply involved with legal and business matters in Korea for many years. He has extensive experience advising in a wide range of practice areas including the food and beverage related industries. As an entrepreneur in the food and beverage sector, he was involved with the first live Maine lobster exports to Korea and Okinawa, Japan, was a co-founder of a cranberry-based food and beverage company, and a principle in a tuna fishing business. He has served on the Board of Governors of the American Chamber of Commerce in Korea (AmCham) for more than a decade and currently serves as Vice Chairman of AmCham. He is also a former Chairman of the Asia–Pacific Council of American Chambers of Commerce (APCAC), the regional grouping of AmChams. He has written and spoken extensively on legal and business issues relating to Korea. He previously practiced law with Hogan & Hartson (now Hogan Lovells) in Washington, DC and with Vinson & Elkins in Austin, Texas.

Barun Law LLC

Barun Law Building

92 gil 7, Teheran-ro, Gangnam-gu, Seoul 135-846

Republic of Korea

[email protected]

Samim Saner

Samim Saner is the General Manager of Kalite Sistem Laboratories Group, Chairman of the Turkish Food Safety Association, and Vice chairman of TurkLab. He gives lectures in the Chemistry Department of Bosphorus University. He has an academic background in chemical engineering, biochemistry, and environmental sciences from Istanbul Technical University, Vienna Technical University, and Bosphorus University, consecutively. He has more than 20 years of experience in food safety and quality along with experience in the fields of public health, training, research, and consultancy for the agrofood sector. He has published numerous articles in various scientific and technical journals; and has also presented various papers at several congresses and seminars. He is an Editorial Board member of a number of international scientific journals, such as Journal of Food Analysis (Springer) and British Food Journal (Emerald).

Kalite Sistem Group

Ar Plaza B Blok Degirmen sokak No. 16

Kozyatagi 34742

Istanbul

Turkey

[email protected]

Wesselina Uebe

Dr. Wesselina Uebe is a Research Associate at the Europe Institute at the University of Zurich (EIZ). She studied law and obtained a Doctoral degree (Dr. iur.) at the University of Cologne, Germany. Her technical knowledge covers the areas EU constitutional law and food law. Furthermore, she is Lecturer in an Advanced Study Program on Swiss and EU food law, which has been established in cooperation with the Zurich University of Applied Sciences (ZHAW).

Europa Institute at the University of Zurich

Hirschengraben 56

8001 Zürich

Switzerland

[email protected]

Olivia Wright

Olivia Wright is an Associate in the Ottawa office of Dentons Canada LLP. Her practice focuses on international trade law, and federal regulatory law, with an emphasis on product regulation, food and drug, communication, and advertising law. She advises clients on food, drug, and other health product approvals, including natural health product registrations and establishment license approvals. She also assists clients with compliance and liability mitigation with respect to industrial and consumer products, including the management of hazard and defect reports to government agencies and product recalls. Her marketing and advertising practice includes competition issues, pricing, packaging, labeling, and promotions. Together with John Blakney, she is Co-Instructor of the Canadian Food Regulation Course at Michigan State University. She holds a law degree from the University of Toronto.

Dentons Canada LLP

99 Bank Street

Suite 1420

Ottawa, ON K1P 1H4

Canada

[email protected]

Oleg Zhabinski

Oleg Zhabinski obtained the degree in International Private Law from the Belarusian State University. In 2008–2009, he studied at the University of Arizona in Tucson, USA and was awarded the Master of Law degree in International Trade Law. He practiced law as in-house lawyer and as legal counsel in a number of prominent national and international companies, before joining the Moscow office of the German consulting firm Rödl & Partner in 2011. In his current capacity as Senior Lawyer, he advises on various issues of intellectual property law, structuring of international commercial transactions, international investments, and regulation of foreign trade.

Röedel & Partner

Elektrosawodskaja ul. 27

107023 Moscow

Russian Federation

[email protected]

1Argentina

Alejandro Ariosti and Margarita Olivera Carrión

1.1 Legal Framework

1.1.1 Introduction

Argentina is a federal country, so her legal framework has national and provincial levels. National laws approved by both Chambers of the National Congress, must be promulgated by Decrees issued by the National Executive Power, which establishes their publication in the Official Bulletin and the period for the law's entry in force. Each province used to have its own food regulation, until 1969, when a national food law was passed. This law created the Argentine Food Code (CAA),1 which is the Annex to National Law 18284/69 and its Regulatory Decree 2126/71. Provinces can pass provincial laws, as long as they do not contradict national laws.

In addition to complying with the CAA, some food groups have a specific set of regulations. For example, for meats and its derivatives, a Regulation on Inspection of Animal Origin Food established by Decree 4238/68 is in force; it has been applied nationwide since 1968 and is updated regularly. The fact that both Decree 4238/68 and the CAA were approved in less than 1 year indicated at that time the need to establish a regulatory framework with defined physical, chemical, and microbiological requisites (among others) for all types of foods. This regulatory framework has been designed to ensure the safety and authenticity of food products, and to avoid their possible adulteration and undesirable modification.

Law 14878/59 on oenological products, approved in 1959, regulates the manufacture and marketing of wines and other oenological products, and is one of the oldest Argentine food laws.

Other mandatory national laws that apply to food commerce are the Consumer Defense Law 24240/93 and the Commercial Loyalty Law 22802/83, which establish, among other topics, net weights and their tolerances for different products.

Geographic Indications and Denominations of Origin for agriculture products and processed foods must comply with Law 25163/99, except in the case of wines, which are covered by Law 25966/04.

The enforcement and fulfillment of these laws require the Ministries to approve specific “Resolutions” that can be applied in particular topics. Decisions issued by bodies dependent on the Ministries are called “Dispositions”, and serve as references for the whole country's jurisdiction; for example:

Dispositions on medical food and energy drinks issued by the Drug, Food and Medical Technology National Administration

2

(ANMAT; dependent on the Ministry of Health).

Dispositions on specific animal and vegetal food issued by the National Service of Agrarian and Food Health and Quality

3

(SENASA; dependent on the Ministry of Agriculture, Livestock and Fisheries).

Finally, in a descending hierarchy, “Ordinances” are issued by Municipalities and apply at the district level.

The sanction of the CAA implied a great update effort in general food aspects and in the specific main food groups. It is recognized as a regulatory improvement at the national level due to the comprehensiveness and depth with which different subjects are treated. At the Latin American level, the CAA also represented a pioneering legal framework and a referent in food legislation for several countries since the 1970s.

The Argentine food scientist Dr. Carlos Grau, a pioneer in advocating harmonization of food regulations, was the main author of the Latin American Food Code (1960), that reproduces the Argentine Federal Food Regulation (1953), the regulation on which the CAA was based.4 The Latin American Food Code was also the basis for several regulations in Latin American countries during the 1960s. A revised version was published in 1964.

The text of Law 18284/69 is relatively short, but its Annex, the CAA, comprises 22 chapters (Table 1.1). The first five chapters can be considered as horizontal, dealing with the following topics: general (Chapter I), processing plant requirements (Chapter II), contaminants and allowed preservation treatments (Chapter III), food packaging and other food contact materials (FCMs) (Chapter IV), and food labeling (Chapter V). Chapter XVIII is also horizontal because it deals with general food additives requirements.

Table 1.1Structure of the CAA

Subject

Description

Chapter

General

General definitions

I

Standards for factories and other facilities

II

Contaminants limits (inorganic, organic, and microbiological); catering and ready meals; preservation methods

III

Food packaging and FCMs

IV

Labeling

V

Specific

Meat products, poultry, fish, and eggs

VI

Oils and fats

VII

Dairy foods

VIII

Farinaceous foods

IX

Confectionery products (including honey and specialties)

X

Vegetal foods

XI

Waters, non-alcoholic beverages, ice creams and powders for their preparation, juices, etc.

XII

Fermented beverages (beer, cider, and wine)

XIII

Alcoholic beverages (distilled spirits, liquors, and aromatic herbs for alcoholic beverages)

XIV

Stimulant products (cocoa, tea, coffee, and “yerba mate”)

XV

General

Auxiliary components (spices, sauces, color additives, essences, etc.)

XVI

Dietary foods

XVII

Food additives

XVIII

Specific

Protein flours, concentrates, and isolates

XIX

General

Analytical methods

XX

Product recall procedures

XXI

Specific

Miscellaneous

XXII

Another chapter that can be considered as horizontal is the one on dietary foods (Chapter XVII). By definition, dietary foods are packaged products modified in their composition by the addition, removal, or replacement of certain components. Due to the ubiquity of products with added vitamins, minerals, in all the text etc., a high proportion of foods on the market are classified within this group, as well as new products developed according to novel guidelines for healthy eating.

The rest of the chapters correspond to specific food groups, and establish their physical, chemical, and microbiological parameters. When an item is modified, the last update date appears in the heading.

1.1.2 Argentina in the MERCOSUR

The establishment of the “Common Market of the South” (MERCOSUR, in Spanish, Mercado Común del Sur; MERCOSUL, in Portuguese, Mercado Comum do Sul) had, as a consequence, the improvement of the Member States' food legislations. Since foods traditionally occupied a relevant role in the markets of the Member States (Argentina, Brazil, Paraguay, and Uruguay) at the moment of its constitution (Treaty of Asunción del Paraguay, 1991), the need to harmonize criteria and regulations was of extreme importance. The Protocol of Ouro Preto (Brazil, 1994) established the present institutional structure of the block. The executive body of the MERCOSUR, which sanctions the harmonized Resolutions on food and food packaging, is the Common Market Group (GMC is its acronym in Spanish and Portuguese).5 On 31 July 2012, Venezuela joined the MERCOSUR (to which she applied as candidate country in July 2006).6

All decisions in the MERCOSUR must be approved by consensus and afterwards they are incorporated into the national regulatory frame, in a process known as transposition. The GMC Resolutions have a systematized structure and are referenced by the designation XX/YY, where XX is the GMC Resolution consecutive number and YY are the two last digits of the year of sanction; for example, GMC Resolution 10/91 (the first Packaged Food Labeling Resolution). In the case of Argentina, the MERCOSUR GMC Resolutions related to foods are transposed into the CAA Chapters at the specific Article, or by creation of a new Article in the corresponding Chapter, or by incorporation as an Annex to the corresponding Chapter.

In the case that new measures approved by the MERCOSUR imply important changes either from the technological or economical point of view, the deadline for entry in force varies depending on the case (e.g., 1 year for the prohibition of potassium bromate as a flour enhancer;7 3 years for mandatory nutritional labeling,8 because it involved a change of all food package labeling).

In the food area, GMC Resolution 59/99 establishes that the MERCOSUR competent bodies must consider as references the standards, principles, and guidelines of the Codex Alimentarius. Other main sources used as references are international guidelines (e.g., recommendations of the Council of Europe or the German Federal Institute for Risk Assessment9 (BfR)) or regulations issued by international institutions (EU Commission, US Food and Drug Administration (FDA), US Department of Agriculture (USDA)).

Since the creation of the MERCOSUR, priority has been given to harmonization of horizontal subjects (labeling, food packaging and other FCMs, additives) and of specific topics for food groups of major commercial importance for the block trade (e.g., dairy products). In some areas, due to their complexity and the possible impact level, each Member State has its own regulations, and at present no criteria harmonization has been possible. As an example, foods in which vitamins and minerals have been added in a voluntary or mandatory way are classified as dietary foods according to the CAA (Chapter XVII), while in other Member States they are not classified as such.

Once sanctioned, the MERCOSUR GMC Resolutions are legally binding for the Member States on harmonized issues, as any technical barrier to trade must be avoided. At the national level, differences may arise on administrative procedures or national authorities in charge of the enforcement, but not on technical issues. In some cases, the national safety authorities of the Member States have complemented, but not altered, some technical aspects of the MERCOSUR GMC Resolutions. For instance, the Argentine Ministry of Health has adopted all the MERCOSUR GMC Resolutions on food additives and has resolved that some of them must be declared with their whole name in the labeling, due to possible adverse effects on specific groups of consumers. These national Resolutions have been incorporated into the CAA (See section 1.4.4). Another example is that in Argentina, the percentage of non-nutritive sweeteners must be declared when used (this specific issue has not yet been discussed in the MERCOSUR).

1.2 Food Safety Authorities and Enforcement Procedures

1.2.1 Introduction

Currently, the Ministries dealing with food health policy, primary production, industrialization, and marketing are the Ministry of Health, Ministry of Agriculture, Livestock and Fisheries, Ministry of Economy and Public Finances, and Ministry of Industry (Figure 1.1). The Ministry of Agriculture, Livestock and Fisheries was created in 2009 by Decree 1366/09 on the basis of the former Secretariat of Agriculture, Livestock, Fisheries and Food (that depended on the Ministry of Economy).

Figure 1.1Structure of national institutions related to food safety.

Food control all over the country is performed by the provincial food control bodies (or Food Control Offices10), under the surveillance of the National Ministry of Health), and the SENASA and its delegations. The National System for Food Control was created in 1999 by Decree 815/99 to consolidate and make food safety surveillance more efficient, enforcing the CAA all over the country (Article 1). In addition, this Decree created the National Food Commission11 (CONAL) (Article 5), and established the responsibilities of the different bodies, as described below.

The Ministry of Health, and the Ministry of Agriculture, Livestock and Fisheries have representatives at the CONAL, the body responsible for the evaluation of proposals for the review and update of the CAA, and of any new relevant application in the food area. The Presidency of the CONAL alternates between the two Ministries.12 The CONAL Meetings Acts are public and can be accessed through the web.

Originally, the SENASA was responsible for the control only of animal-origin food production. Nowadays, this body depends on the Ministry of Agriculture, Livestock and Fisheries, and it deals with the control of bulk production of all types of food of animal and vegetal origin (with certain exceptions) and their packaging materials, for domestic commerce between provinces and for import/export, implementing food safety policies in its area.13

The National Food Institute (INAL),14 dependent on the ANMAT, is responsible for the control of foods and packaging materials intended for internal commerce and for import/export, not covered by other bodies, with special emphasis on food conditioned and labeled for direct sale, implementing food safety policies in its area.15

Another body dependent on the Ministry of Agriculture, Livestock and Fisheries, with responsibility in food control, is the National Institute of Vitiviniculture (INV).16 It deals with vine cultivation, grape harvest, wine (and other oenological products) production, packaging, trade, etc., implementing food safety policies in its area.

The Ministry of Economy and Public Finances is also involved in food control, through the Secretariat of Interior Commerce, which is responsible for the enforcement of the Commercial Loyalty and Consumer Defense Laws. These laws establish, according to the nature of the products, the weight tolerances, food labeling requirements, food packaging metrology (certain allowed volumes and weights), etc.

Some national institutions, such as the National Institute of Industrial Technology (INTI),17 dependent on the Ministry of Industry, and the National Institute of Agrarian Technology (INTA),18 dependent on the Ministry of Agriculture, Livestock and Fisheries, perform research and development activities in different areas of the food value chain, and help to update and adopt new products and technologies in a safe way.

INTI's technical representatives from its different Centers,19 along with technical representatives from the Ministries, ANMAT, INAL, INTA, SENASA, etc., participate in the MERCOSUR Technical Working Groups and Committees since 1991 (e.g., the MERCOSUR Food Commission).

1.2.2 Food Processing Plants

In Argentina, food processing plants and processed products must be approved by the responsible official body. The clearance of food processing plants is performed in two stages: (i) the municipalities approve the facilities, according to the building codes that apply in the jurisdictions, and (ii) the provincial food control bodies (or Food Control Office) approve the operation of the factories, according to a consistent flow diagram of the processes involved in food manufacture (e.g., to avoid cross-contamination). Food plants must also have an environmental assessment report approved by the environmental authority. Official inspectors perform visits to the plants and audit all the aspects considered necessary, helped by check lists provided by the safety authorities. Non-conformities may arise in this process; when they are minor, a provisional approval can be granted; when the situation is regularized, the final approval is issued.

After these requirements are met, a national identification number is granted: the National Factory Register (RNE)20 number, which consists of eight digits; the first two digits identify the Province and the other six, the consecutive order of approval. Not only food processing plants, but also distribution centers, import/export warehouses, etc., must be identified by the RNE number.

The SENASA is the body responsible for the clearance of animal-origin products processing plants, such as cattle slaughterhouses, milk processing plants, honey extraction plants, vehicles for certain food transportation, etc. In these cases, the SENASA grants a specific code for the authorized food processing plant, but the RNE number issued by the provincial Food Control Office is always needed.

Industrial plants that process food by irradiation must be approved by the national food safety authority, with previous assessment by the National Commission of Atomic Energy (CNEA),21 which must also control the radiological safety of the plant operation.22 The CNEA, created in 1950 by Decree 10936/50, depends on the Ministry of Federal Planning, Public Investment and Services.

Some food processing plants (e.g., water bottling, dairy products, meat products, food additives, and food products classified as dietary foods according to the CAA, Chapter XVII) must have a Technical Director who must be a professional with a University degree.23

1.2.3 Food Products

All foods must be approved by the Food Control Offices prior to their release in the market (pre-market approval system). The manufacturer must submit a dossier describing briefly the manufacturing process, the percentage composition of the product, its shelf-life and the way it was determined, and a draft of the package labeling. The manufacturer proposes the sale denomination of the product, but in the end, it is the food safety authority that establishes it, according to the food classification or composition. As an example, a breakfast cereal can be a normal product; however, if vitamins or minerals are added to it, the product becomes a “fortified” product and it is classified as a “dietary food” – accordingly, the sale denomination of the product is “breakfast fortified cereal” (thus, as seen previously, the processing plant must have a Technical Director).

According to the pre-market approval system of FCMs in force in Argentina,24 the food packaging manufacturer must submit technical reports on the safety assessment of the food packaging to the national or provincial authority for its clearance. The food manufacturer is obliged to keep a copy of the food packaging clearance in its files.

When a food product is approved, a national identification number is granted: the National Food Product Register (RNPA)25 number, which also consists of eight consecutive digits for each facility. It must be noted that whilst there is only one RNE number for each facility of each company in the country, the RNPA number may be repeated, as the numbering will be consecutive for all products manufactured at each plant.

The RNPA number must be granted before marketing the product in the country. Once it is granted, in general it does not expire, although some jurisdictions require its renewal every 5 years. In the case of some specific products such as dietary supplements, the RNPA number must be always renewed every 5 years. Once the manufacturer submits the information to obtain the RNPA number, the food safety authority has 30 days to grant it. If after this period the food safety authority does not take a decision, the company can begin to market the product using the submission number, until the final official decision.

Both the RNE and RNPA numbers must be printed on the package labeling of all products. With this information on the labeling, it is possible to know if the product is legally marketed by an authorized company.

In the case of products approved by the SENASA (e.g., dairy products, products with more than 80% meat (hamburgers, processed meat derivatives)), the specific codes granted by this food safety authority must also be printed in the package labeling. These codes have the format X/Y/Z, where X corresponds to the facility, Y to the product, and Z to its presentation in different weights or number of units (e.g., sausages, hamburgers).

1.3 Basic Principles of Food Law

1.3.1 Positive Regulation

The CAA is a regulation based on the positive principle. This means that only processes and additives expressly mentioned in it are allowed.26 Originally, the CAA contemplated the great majority of the products in the market. Nevertheless, Article 3 states that all kinds of food can be manufactured, as long as only those processes and additives allowed for products of a similar nature are applied. This Article has been very useful, due to the wide range of foods developed in the last decades.

1.3.2 Traceability

Traceability systems are in different stages of development, depending on the different food groups. All raw materials stored in a facility must be adequate, labeled as intended for processing foods, of known origin, and provided by an authorized manufacturer.

In 2011, the food safety authorities approved a national integrated system for processing plants and manufactured products, called the Federal Program of Food Control. The main feature is a database of public consultation that can be used to determine, by means of the RNE and RNPA numbers printed in the package labeling, if the processing plant and the food product are approved. Since its creation all the Argentine Provinces have been incorporated into this Program.

Furthermore, the lot number must be printed on each product package. This allows identifying the product record, according to the criteria established by the manufacturer (e.g., manufacturing date, packaging line, elaboration tank).

Due to sporadic foot-and-mouth disease (FMD) cases and the key role of cattle health in the Argentine economy, it is extremely controlled and traceability can be established for each animal.

Another example where traceability is of great importance is the case of post-consumer polyethylene terephthalate (PET) packages recycling. MERCOSUR GMC Resolution 30/07 was transposed into the CAA as an Annex to Chapter IV. It establishes that traceability must be maintained along the value chain of the recollection, decontamination, and use of post-consumer recycled PET (PCR-PET). The stakeholders in this value chain are: (i) the manufacturer of PCR-PET (through recollection, washing, and decontamination of post-consumer PET bottles, in approved facilities operating with licensed technologies that must have “No Objection Letters” (NOLs) to their use from the US FDA or favorable Decisions on their use by the European Food Safety Authority (EFSA); (ii) the converters that use mixtures of PCR-PET and virgin PET to manufacture parisons or preforms; (iii) the food manufacturer that blows the parisons into PET bottles and fills them with the foodstuff (e.g., soft drinks); and (iv) the consumer. These bottles can be found today in the Argentine market and are indelibly marked with the (Spanish) acronym “PET-PCR,” and thus can be easily identified by the consumer or the safety inspector.

1.3.3 Precautionary Principle

For a number of years, the precautionary principle has been used in some product labeling, where warnings on the presence of allergens have been incorporated by food companies (e.g., “This product is manufactured in plants where peanuts, soy, etc., are processed”). The food safety authorities have banned this kind of warning, demanding to declare unambiguously if the specific allergen is present or not in the product. The capability of available methods used to accurately establish the levels of different allergens, according to the elaboration process, is still a matter of study. The use of these warnings is in suspense, as analytical work in this area is proceeding.

Another example is the case of the prohibition of the manufacture of feeding bottles and other drinking devices for infants with bisphenol A (BPA)-based polymers.27 In this sense, the MERCOSUR and the Member States followed the policy of the EU Commission, which applied the precautionary principle, among other considerations, to forbid the use of BPA for the manufacture of polycarbonate infant feeding bottles,28 although at present (February 2014) the technical opinion of the EFSA is that no risk is associated with the normal use of BPA-based baby feeding bottles.29

1.3.4 Responsibility Principle

Food processing plant approval is granted by the food safety authorities to the company owners. In cases where a Technical Director is needed, the responsibility for the product is shared between him/her and the owners.30 As long as products are approved by the food safety authorities, the responsibility is also shared by the State. The company employees are responsible for infractions, and the company owners, managers, and technical directors also share this responsibility.31

In the case of food packaging, the responsibility is also shared between the food safety authority (that approves the package), the packaging manufacturer (who must sell only approved packages), and the food manufacturer (who must buy and use only approved packages).

1.4 Overview of Selected Regulation Areas

1.4.1 Mandatory Nutritional Labeling

One of the most important changes in Argentine food legislation is the new mandatory nutritional food labeling applied since August 2006 for packaged food, with specific exceptions (alcoholic beverages, mineral water, spices, vinegars, infusions).

The new framework of GMC Resolutions was adopted by the MERCOSUR Member States in 2003. A 3-year transitional period was established so that industry could assimilate the new concepts and adapt to the proper labeling rules. In 2006, another complementary regulation was approved.32 The main changes introduced were: (i) nutritional information per serving was made compulsory for all types of foods, while previously it was mandatory only for dietary foods and voluntary for all other types of foods, and had to be expressed per 100 g or 100 ml; (ii) information on Energetic Value (EV) and certain nutrients (carbohydrates, proteins, total fats, saturated fats, trans fats, dietary fiber, and sodium), is now required; (iii) the percent coverage of Daily Values (%DV) according to Food and Agriculture Organization/World Health Organization (FAO/WHO) recommendations, must also be given; (iv) in the case of trans fats, there is no recommended value; (v) for sodium, the daily value established is 2400 mg; (vi) non-significant values per serving were established for every attribute;33 and (vii) tolerances allowed for the declared value of the contents for all nutrients and EV are ±20%.

In Argentina, the CONAL has established that the information of the nutritional labeling may be based on food chemical analysis or may be taken from centesimal composition tables. For some components, like saturated and trans fatty acids, laboratories have updated their analytical capability and a better use of compositional tables is in process.

The addition of some optional nutrients is contemplated, like specific carbohydrates (sugars, polyalcohols, starch) and other fat components (cholesterol, mono-, and polyunsaturated fatty acids). Vitamins and minerals may be included only if their amount per serving is higher than 5% of the Dietary Reference Intakes (DRIs) established by the FAO/WHO.

Information must be presented in the way the food is bought. Servings must be expressed in g or ml and home measurement. EV, nutrients, and %DV must be presented in a pre-established order in a table format (Table 1.2).

Table 1.2Example of nutritional information labeling

Nutritional Information Serving …g or …ml (home measurement)

Amount per serving

%DV

a

Energetic value

kcal and kJ

Carbohydrates

… g

Proteins

… g

Total fats

… g

Saturated fats

… g

Trans fats

… g

(Not established)

Dietary fiber

… g

Sodium

… mg

a