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Ensuring Global Food Safety: Exploring Global Harmonization
Ensuring Global Food Safety: Exploring Global Harmonization
Ensuring Global Food Safety: Exploring Global Harmonization
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Ensuring Global Food Safety: Exploring Global Harmonization

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Taking into account toxicity levels at normal consumption levels, intake per kg bodyweight and other acknowledged considerations, each chapter in this book will be based on one or more proven examples. It is intended to provide specific examples and potential improvements to the safety of the world's food supply, while also increasing the amount of food available to those in undernourished countries. This book is designed to to provide science-based tools for improving legislation and regulation.
  • Reduce amount of food destroyed due to difference in regulations between nations
  • Positively impact the time-to-market of new food products by recognizing benefit of "one rule that applies to all"
  • Use the comparison of regulations and resulting consequences to make appropriate, fully-informed decisions
  • Employ proven science to obtain global consensus for regulations
  • Understand how to harmonize test protocols and analytical methods for accurate measurement and evaluation
  • Take advantage of using a risk/benefit based approach rather than risk/avoidance to maximize regulatory decisions
LanguageEnglish
Release dateNov 11, 2009
ISBN9780080889306
Ensuring Global Food Safety: Exploring Global Harmonization

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    Ensuring Global Food Safety - Christine Boisrobert

    Table of Contents

    Cover image

    Copyright

    Foreword

    Preface

    Acronyms and Abbreviations

    Contributors

    Chapter 1. Ensuring Global Food Safety—A Public Health Priority and a Global Responsibility

    Chapter 2. Development of Food Legislation Around the World

    2.1. Introduction

    2.2. International Food Law

    2.3. India

    2.4. South Africa

    2.5. Eastern Africa

    2.6. Australia and New Zealand

    2.7. The United States and Canada

    2.8. Latin America

    2.9. European Union

    2.10. Near East

    2.11. Northeast Asia

    2.12. China

    2.13. The Russian Federation

    2.14. Concluding Observations

    Chapter 3. The Global Harmonization Initiative

    3.1. Introduction

    3.2. Drivers for Global Harmonization of Food Safety Legislation and Regulations

    3.3. Advances and Achievements in Harmonizing Food Safety Policy

    3.4. The Global Harmonization Initiative

    3.5. Conclusion

    Chapter 4. A Simplified Guide to Understanding and Using Food Safety Objectives and Performance Objectives

    4.1. Introduction

    4.2. Good Practices and Hazard Analysis Critical Control Point

    4.3. Setting Public Health Goals—the Concept of Appropriate Levels of Protection

    4.4. A Food Safety Objective

    4.5. A Performance Objective

    4.6. The Difference between a Food Safety Objective, Performance Objective and Microbiological Criteria

    4.7. Responsibility for Setting a Food Safety Objective

    4.8. Setting a Performance Objective

    4.9. Responsibility for Compliance with the Food Safety Objective

    4.10. Meeting the Food Safety Objective

    4.11. Not All Food Safety Objectives are Feasible

    4.12. Concluding Remarks

    Chapter 5. Global Harmonization of Analytical Methods

    5.1. Introduction

    5.2. Methods for Establishing the Basic Composition, Quality, or Economic Value of Foods

    5.3. Methods for Establishing the Nutrient Content of Foods

    5.4. Methods for Detecting or Confirming the Absence of Contaminants in Foods

    5.5. Conclusion

    Chapter 6. Water Determination in Food

    6.1. Introduction

    6.2. Water Content

    6.3. Water Determination in Dairy Powders

    6.4. Water Content Determination by Near-Infrared Spectroscopy

    6.5. Conclusion

    Chapter 7. Testing for Food Safety Using Competent Human Liver Cells

    7.1. Assessment of Human Food Safety and the Existing Problems

    7.2. Assessing Genotoxic Potential of Human Dietary Components Using Human Hepatoma HepG2 Cells

    7.3. Validation of Human HepG2 Cells in Detecting Known Carcinogens and Non-Carcinogens

    7.4. Assessment of the Genotoxic Potential of Mycotoxins in HepG2 Cells

    7.5. Assessment of the Genotoxic Potential of Heterocyclic Aromatic Amines in HepG2 Cells

    7.6. A Comparative Analysis for Phase I and Phase II Enzymes between HepG2 Cells and Human Hepatocytes

    7.7. Toxicity Studies of Compounds and Mechanistic Assays on NAD(P)H, ATP, DNA Contents (cell proliferation), Glutathione Depletion, Calcein Uptake and Radical Oxygen Assay Using Human HepG2 Cells

    7.8. Application of a Human HepG2 Cell System to Detect Dietary Anti-genotoxicants

    7.9. The Use of Genomic and Proteomic Technologies in Human HepG2 Cells

    7.10. Conclusion

    Chapter 8. Capacity Building

    8.1. Introduction

    8.2. Capacity Building

    8.3. The Role of Multilateral Agreements in Achieving Food Safety

    8.4. Conclusion

    Chapter 9. Capacity Building

    9.1. Introduction

    9.2. Significance of Microbial Food Safety

    9.3. Staphylococcus and Its Species

    9.4. Yersinia Enterocolitica

    9.5. Listeria Monocytogenes

    9.6. Bacillus Cereus

    9.7. Capacity Building Initiative at CFTRI

    Chapter 10. Global Harmonization of the Control of Microbiological Risks

    10.1. Introduction

    10.2. Microbiological Food Safety Management

    10.3. Microbiological Criteria

    10.4. Microbiological Testing

    10.5. Validation of Microbiological Methods

    10.6. Harmonization of Global Regulations for Listeria monocytogenes in Ready-to-Eat Foods

    10.7. Conclusion

    Chapter 11. Towards Intended Normal Use (Part I)

    11.1. Introduction

    11.2. The ‘Nature’ of Antibiotics

    11.3. Chloramphenicol—History, Law and Science (Hanekamp, Frapporti, & Olieman, 2003)

    11.4. Toxicology—Potential Risks of CAP Exposure through Food

    11.5. Toxicology—Models of Analysis

    11.6. Regulatory Developments—Europe and Beyond (Hanekamp, 2005)

    11.7. Basic Resolutions—Intended Normal Use

    11.8. Conclusions

    Chapter 12. Mycotoxin Management

    12.1. Introduction

    12.2. Mycotoxin Regulations

    12.3. Harmonized Regulations

    12.4. Trade Impact of Regulations

    12.5. Technical Assistance

    12.6. Conclusion

    Chapter 13. Monosodium Glutamate in Foods and its Biological Effects

    13.1. Introduction

    13.2. The Umami Taste

    13.3. MSG in Human and Animal Metabolism

    13.4. Nutritional Studies

    13.5. Toxicological Studies

    13.6. MSG Sensitivity

    13.7. Health Effects on Infants

    13.8. Other Effects

    13.9. Safety Evaluation of MSG

    13.10. Labeling Issues

    13.11. Future Perspectives

    Chapter 14. Food Packaging Legislation

    14.1. Introduction

    14.2. Food Contact Materials Legislation in the European Union

    14.3. Food Contact Materials Legislation in the United States of America

    14.4. Food Contact Materials Legislation in Japan

    14.5. Food Contact Materials Legislation in MERCOSUR

    14.6. Council of Europe Technical Recommendations on Food Packaging Materials

    14.7. Food Contact Materials in the Codex Alimentarius

    14.8. Comparison of FCMs Legislations

    14.9. Conclusions—Harmonization, Mutual Recognition, and New Legislation

    Chapter 15. Nanotechnology and Food Safety

    15.1. Introduction

    15.2. Nanotechnology and Food Systems

    15.3. Current Status of Regulation of Nanomaterials in Food

    15.4. Hurdles in Evaluation and Regulation of the Use of Nanotechnology in Foods

    15.5. Future Developments and Challenges

    Chapter 16. Novel Food Processing Technologies and Regulatory Hurdles

    16.1. Introduction

    16.2. Novel Technologies

    16.3. Non-Thermal Technologies

    16.4. Thermal Technologies

    16.5. Legislative Issues Concerning Novel Technologies

    16.6. Global Harmonization Concerning Novel Technologies

    16.7. concluding Remarks

    Chapter 17. Nutrition and Bioavailability

    17.1. Introduction

    17.2. Scope

    17.3. Methodology

    17.4. Structure of the Review

    17.5. Overview of Nutrition Labeling

    17.6. Similarities and Differences between Countries

    17.7. Consumer Understanding and Use of Nutrition Labels

    17.8. Bioavailability and Nutrition Labeling

    17.9. Conclusion

    Chapter 18. New RDAs and Intended Normal Use (Part II)—Efficient Tools in the Universal Management of Risks and Benefits of Micronutrients

    18.1. Introduction

    18.2. Standardizing Food—European Food Standards Legislation

    18.3. The Science of Micronutrient Safety—Hazards, Risks, Benefits, and Precaution

    18.4. Assessing European Micronutrient Policies—The Adequate, Varied and Balanced Diet

    18.5. Precautionary Impediments

    18.6. Micronutrients, Human Health, and Science—The State-of-Art and Beyond

    18.7. The nRDA-Genomic Integrity Homeostasis U-shape Curve

    18.8. Integrating nRDAs in the Model of Intended Normal Use—Towards Regulatory Maturation (Schwitters et al., 2007)

    18.9. Safety, Good Manufacturing Practice and Initial Type Testing

    Chapter 19. Nutraceuticals

    19.1. Introduction

    19.2. Challenges Facing Nutraceuticals

    19.3. The Molecule–Gene Interaction

    19.4. Conclusion

    Chapter 20. Harmonization of International Standards

    20.1. Introduction

    20.2. World Trade Organization

    20.3. The Codex Alimentarius Commission and Other United Nations Agencies

    20.4. World Organisation for Animal Health

    20.5. International Organization for Standardization

    20.6. PAS 220

    20.7. Global Food Safety Initiative

    20.8. Conclusion

    20.9. International Trade Related Websites

    Chapter 21. The First Legislation for Foods with Health Claims in Korea

    21.1. Introduction

    21.2. Health/Functional Food Act

    21.3. Health Claims Allowed For HFFs

    21.4. Scientific Substantiation of Health Claims for HFFs

    21.5. Future Direction

    Chapter 22. Bioactivity, Benefits and Safety of Traditional and Ethnic Foods

    22.1. Introduction

    22.2. Objective

    22.3. Scope

    22.4. Methodology

    22.5. Structure of the Review

    22.6. Food and Chronic Diseases

    22.7. Biological Mechanism of Bioactive Food Compounds

    22.8. Bioactive Food Compounds in Traditional/Ethnic Foods

    22.9. Conclusion

    22.10. Future Scope

    Chapter 23. Processing Issues

    23.1. Introduction

    23.2. Acrylamide

    23.3. Furan

    23.4. Trans Fatty Acids

    23.5. Conclusions

    Chapter 24. Responding to Incidents of Low Level Chemical Contamination in Food

    24.1. Introduction

    24.2. Risk Analysis

    24.3. General Control Measures for Chemicals

    24.4. Case Studies

    24.5. Conclusion

    Abatract 1. Integrating Risk Assessment and Cost Benefit Analysis: An Economics Perspective on International Trade and Food Safety

    Abstract 2. Food Additives and Other Substances Added to Human Foods

    Abstract 3. Global Harmonization of Food Regulations: Benefits and Risks of Organic Food

    Index

    Copyright

    Academic Press is an imprint of Elsevier

    32 Jamestown Road, London, NW1 7BY, UK

    30 Corporate Drive, Suite 400, Burlington, MA 01803, USA

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

    First edition 2010

    Copyright © 2010, Elsevier Inc. All rights reserved with the exception of:

    Chapter 2© 2010 by B.M.J. van der Meulen and Elsevier Inc.

    Chapter 3© 2010 by Larry Keener and Elsevier Inc.

    Chapter 4© 2010 by The International Commission on Microbiological Specifications for Foods (ICMSF).

    Chapter 8© 2010 by Larry Keener.

    Chapter 23 is in the Public Domain.

    Additional Reading Abstract 1 is in the Public Domain.

    Additional Reading Abstract 2 © 2010 by Larry Keener.

    No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the publisher

    Permissions may be sought directly from Elsevier’s Science & Technology Rights Department in Oxford, UK: phone: (+44) (0) 1865 843830; fax: (+44) (0) 1865 853333; email: permissions@elsevier.com. Alternatively visit the Science and Technology Books website at www.elsevierdirect.com/rights for further information

    Notice

    No responsibility is assumed by the publisher 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. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made

    Library of Congress Cataloging in Publication Data

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

    British Library Cataloguing in Publication Data

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

    ISBN: 978-0-12-374845-4

    For information on all Academic Press publications visit our website at www.elsevierdirect.com

    Printed and bound in United States of America

    10 11 12 13 10 9 8 7 6 5 4 3 2 1

    Foreword

    Prof. Dr. Viktor Nedović

    Assistant Minister for International Scientific and Technological Cooperation

    Ministry of Science and Technological Development

    Government of the Republic of Serbia

    Ass. Prof. at Dept. of Food Technology and Biochemistry, Faculty of Agriculture, University of Belgrade, Belgrade, Serbia

    Member of the Executive Committee of the European Federation of Food Science & Technology (EFFoST)

    The production, processing, distribution, retail, packaging and labeling of foodstuffs are governed by a vast number of laws, regulations, codes of practice and guidance. Most food safety legislation and regulations were devised in the first decades after the Second World War, at times when analytical methods were much less advanced than today. More recent legislation and regulations often have been developed in response of media scares. Today’s reality is that there are differences in regulations between countries that force the food community to check the safety over and over again, depending on where the products are produced, from where they or their ingredients originate, or to where they are exported. In addition to wasting time and money, this also too often leads to severe measures such as the destruction of huge quantities of food, despite lacking any scientific justification, to protect consumers, while a large part of the human population suffers from undernourishment. This book provides examples and discusses possible means of improvement of the current situation in the field of food regulations. It strongly supports the idea of the necessity to establish an integral system of globally accepted food safety protocols. Actually, this idea was launched by the Global Harmonization Initiative (GHI), a network of scientific organizations and individual scientists that was initiated to help eliminate differences in regulations and legislation. This book represents a step forward towards the harmonization of food safety regulations and legislation worldwide.

    The intention of this book is to bundle the extensive information on food regulations through history and over all continents into a comprehensive reference; and it presents, complete, up-to-date information on contemporary food safety issues related to the global food supply chain. Various questions and issues relating to food production frequently raised in the supply chain from farming to retail are covered, including control of microbiological risks, approaches to managing low level contaminants in foods, processing issues, applications of antibiotics in food, traditional and organic foods in the scope of safety and nutrition, carcinogenicity and toxicity issues, and finally, the issue of balance between benefits and safety risk. Possibilities for global harmonization of test protocols and analytical methods are also discussed, while the interest in further research into novel methods and ingredients and novel food processing technologies against regulatory hurdles is argued.

    Combining scientific, technological, and legal aspects, over 30 carefully selected scientists and food safety professionals from academia, industry, and government across the world have contributed unique expertise and knowledge ensuring the safety and quality of the food supply for consumers.

    Preface

    Christine Boisrobert, Aleksandra Stjepanovic, Sangsuk Oh and Huub Lelieveld

    Food safety is generally recognized as the biological, chemical or physical status of a food that will permit its consumption without incurring excessive risk of injury, morbidity or mortality. It is also true that assessing food safety risk is frequently steeped in either or both political and normative considerations. National governments promote and promulgate food safety laws, regulations and legislation that can be in sharp contrast to those of other countries. These disparities frequently give rise to onerous trade barriers that masquerade as public health protection. Science and certainly scientific consensus on the status of the food, from a food safety perspective, may be overlooked during the rulemaking process.

    International differences in food safety regulations are disruptive to trade and frequently cause confusion among consumers as to the public health status of a food. Food deemed safe by an exporting nation may be regarded as unsafe by an importing nation. This debate often results in the seizure and destruction of food without a clear scientific basis or justification. Likewise novel food processing and preservation technologies or novel food ingredients are scrutinized for safety using protocols, procedures and standards that differ by country. These measures are taken to protect consumers from exposure to food that may adversely affect their health.

    It is difficult to conceive, generally, that a food considered safe for one population would be unsafe for another. Yet and because of differences in food use and preparation among countries, food safety regulations frequently have a basis in the local history and tradition rather than science. Harmonization of food safety regulations would potentially reduce the legal, but scientifically unjustified, destruction of food. Likewise harmonization of legislation and standards may result in eliminating the duplication in the need to prove the safety of novel foods and food ingredients, and consequently the high costs, to satisfy local authorities.

    The Global Harmonization Initiative (GHI) is a non-governmental organization that seeks to obtain consensus among individual scientists, globally, on those contentious issues that require resolution. Consensus documents and white papers developed by GHI may be used as powerful tools in the discussions between stakeholders and are intended to promote the development of regulations based on sound science. The authors that have contributed to this work have described many of the reasons why regulations differ and what difficulties must be overcome to resolve such differences. The book provides a detailed insight into food safety regulations around the world and discusses methods to determine the safety of foods, ingredients and food-contact materials. It also addresses food contaminants, including the impact and implications for food safety of those that may be present in very low levels. Furthermore, it provides abstracts of additional reading materials accessible through the publisher’s website about integrating risk assessment and cost benefit analysis, food additives and other substances added to foods, and benefits and risks of organic food in relation to harmonization of food safety regulations.

    Considering the abundance of pre-existing literature on the topic and the complexity of the subject, this book does not cover genetically modified food.

    The editors are immensely grateful to the authors who contributed tremendous effort and time to create this volume. In addition, we thank Nancy Maragioglio and Carrie Bolger of Elsevier for their support and patience with us, the editors, during the development of this book.

    August 2009.

    Acronyms and Abbreviations

    2-AAF

    2-acetylaminofluorene.

    25(OH)D

    25-hydroxyvitamin D.

    3-MC

    3-methylcholantene.

    4-AAF

    4-acetylaminofluorene.

    AB

    Alamar Blue.

    AB

    Appellate Body.

    ACFCR

    ASEAN Common Food Control Requirements.

    ADA

    American Dietetic Association.

    ADFCA

    Abu Dhabi Food Control Authority.

    ADI

    Acceptable Daily Intake.

    ADME

    Absorption, Distribution, Metabolism and Excretion.

    AFB1

    Aflatoxin B1.

    AFM

    Atomic Force Microscope.

    AFNOR

    Association Française de Normalisation (French).

    AFSC

    Australian Food Standards Code.

    AIDS

    Acquired Immune Deficiency Syndrome.

    AK

    Adenylate Kinase.

    ALARA

    As Low As Reasonably Achievable.

    ALOP

    Appropriate Level of Protection.

    ALS

    Amyotrophic Lateral Sclerosis.

    AMA

    American Medical Association.

    AMPA

    α-amino-3-hydroxy-5-methyl-4-isoxazole propionate.

    ANSI

    American National Standards Institute.

    ANZCERTA

    Australia New Zealand Closer Economic Relations Trade Agreement.

    ANZFA

    Australia New Zealand Food Authority (renamed FSANZ).

    AOAC

    Association of Analytical Communities (formerly Association of Official Analytical Chemists).

    APEC

    Asia-Pacific Economic Cooperation.

    AQIS

    Australian Quarantine and Inspection Service.

    AQSIQ

    General Administration of Quality Supervision, Inspection and Quarantine of PRC.

    ARfD

    Acute Reference Dose.

    ARLs

    ASEAN Reference Laboratories.

    ASEAN

    Association of Southeast Asian Nations.

    ATP

    Adenosine Triphosphate.

    AU

    African Union.

    B(a)P

    Benzo(a)pyrene.

    B(e)P

    Benzo(e)pyrene.

    BHA

    Butylated Hydroxyanisole.

    BHT

    Butylated Hydroxytoluene.

    BIS

    Bureau of Indian Standards.

    BLEB

    Buffered Listeria Enrichment Broth.

    BMC

    Bone Mineral Content.

    BMD

    Bone Mineral Density.

    BMELV

    Federal Ministry of Food, Agriculture and Consumer Protection (Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz, German).

    BNF

    British Nutrition Foundation.

    bp

    base pair.

    BRC

    British Retail Consortium.

    BSE

    Bovine Spongiform Encephalopathy.

    BSI

    British Standards Institution.

    BVL

    Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, German).

    bw

    body weight.

    CAC

    Codex Alimentarius Commission.

    CACCLA

    Codex Alimentarius Coordinating Committee for Latin America.

    CACM

    Central American Common Market.

    CAFTA

    Council of Food Technology Associations.

    CAP

    Chloramphenicol.

    CARICOM

    Caribbean Community and Common Market.

    CASCO

    Committee on Conformity Assessment.

    CAST

    Council for Agricultural Science and Technology.

    CBA

    Cost-Benefit Analysis.

    CBOs

    Community-Based Organizations.

    CCFAC

    Codex Committee on Food Additives and Contaminants.

    CCFH

    Codex Committee on Food Hygiene.

    CCFL

    Codex Committee on Food Labelling.

    CCFNSDU

    Codex Committee on Nutrition and Foods for Special Dietary Uses.

    CCP

    Critical Control Point.

    CDC

    Centers for Disease Control and Prevention.

    CEDI

    Cumulative Estimated Daily Intake.

    CEDR

    European Council for Agricultural Law (Comité Européen de Droit Rural, French).

    CEF

    EFSA Panel on food contact materials, enzymes, flavourings and processing aids.

    CEN

    European Committee for Standardization (Comité Européen de Normalisation, French).

    CEO

    Chief Executive Officer.

    CEPI

    Confederation of European Paper Industries.

    CETEA-ITAL

    Packaging Technology Center – Institute of Food Technology.

    CF

    Consumption Factor.

    CFIA

    Canadian Food Inspection Agency.

    CFR

    Code of Federal Regulations.

    CFSAN

    Center for Food Safety and Applied Nutrition.

    CFSI

    Caribbean Food Safety Initiative.

    CFTRI

    Central Food Technological Research Institute.

    CFU

    Colony-Forming Unit.

    CHO

    Chinese Hamster Ovary.

    CIA

    Central Intelligence Agency.

    CIAA

    Confederation of the Food and Drink Industries of the EU (Confédération des Industries Agro-Alimentaires de l’ UE, French).

    CIES

    The Food Business Forum (Comité International d’Entreprises à Succursales, French)

    CMC

    Common Market Council (Consejo del Mercado Común, Spanish).

    COAG

    Council of Australian Governments.

    CoE

    Council of Europe.

    COPAIA

    Pan American Commission for Food Safety (Comisión Panamericana de Inocuidad de los Alimentos, Spanish).

    CP

    Cyclophosphamide.

    CRS

    Chinese Restaurant Syndrome.

    CSREES

    Cooperative State Research, Education, and Extension Service.

    CUT

    Come-Up Time.

    CYP

    Cytochrome P450

    CytK

    Cytotoxin K.

    DAFF

    Department of Agriculture, Fisheries and Forestry.

    DC

    Dietary Concentration.

    D-E

    Deficiency-Excess.

    DEFT

    Direct Epifluorescent Filter Technique.

    DEH

    Department of Environment and Heritage.

    DG

    Directorate General (Directorat Général, French)

    DG SANCO

    Directorate General for Health and Consumers (Directorat Général de Santé et Protection des Consommateurs, French).

    DIG

    Digoxigenin.

    DM

    Dry Matter.

    DMN

    Dimethylnitrosamine.

    DMSO

    Dimethyl Sulfoxide.

    DNA

    Deoxyribonucleic Acid.

    DON

    Deoxynivalenol.

    DP

    Degree of Polymerization.

    DRF

    Simulant D Reduction Factor.

    DSB

    Dispute Settlement Body.

    dsDNA

    Double-stranded DNA.

    DSHEA

    Dietary Supplement Health and Education Act.

    DV

    Daily Value.

    EAR

    Estimated Average Requirement.

    EC

    European Commission.

    EC Treaty

    European (Economic) Community Treaty (of 1957)

    ECCS

    Electrolytic Chromium Coated Steel also see TFS.

    EDI

    Estimated Daily Intake.

    EDTA

    Ethylenediaminetetraacetic acid.

    EEC

    European Economic Community.

    EFFoST

    European Federation of Food Science and Technology.

    EFLA

    European Food Law Association.

    EFSA

    European Food Safety Authority.

    EFTA

    European Free Trade Association.

    EHEDG

    European Hygienic Engineering and Design Group.

    EIA

    Enzyme Immunoassay.

    ELIFA

    Enzyme-Linked Immunofiltration Assay.

    ELISA

    Enzyme-Linked Immunosorbent Assay.

    ELOSA

    Enzyme-Linked Oligosorbent Assay.

    ENM

    Engineered Nano Materials.

    EPA

    Environmental Protection Agency.

    EPHX1

    Epoxide Hydrolase 1.

    ERIC

    Enterobacterial Repetitive Intergenic Consensus.

    ERP

    Expert Review Panel.

    ERS

    Economic Research Service.

    EtOH

    Ethanol.

    EU

    European Union.

    EuCheMS-FCD

    European Association for Chemical and Molecular Sciences-Food Chemistry Division.

    EVM

    Expert Group on Vitamins and Minerals.

    FAO

    Food and Agriculture Organization.

    FASEB

    Federation of American Societies for Experimental Biology.

    FCCP

    Carbonyl cyanide 4-(trifluoromethoxy) phenylhydrazone.

    FCD Act

    Foodstuffs, Cosmetics and Disinfectants Act.

    FCM

    Food Contact Material.

    FCN

    Food Contact Notification.

    FCS

    Food Contact Substance.

    FCS

    Food Control System.

    FDA

    Food and Drug Administration.

    FDAMA

    Food and Drug Administration Modernization Act.

    FD&C Act

    Federal Food, Drug and Cosmetic Act (also FFDCA, FDCA).

    FFDCA

    Federal Food, Drug and Cosmetic Act (also FDCA, FD&C).

    FFR

    Food Fortification Regulation.

    FLAG

    Food Legislation Advisory Group.

    FMC

    Food Microbiology Subcommittee.

    FNB

    Food and Nutrition Board.

    FRF

    Fat Reduction Factor.

    FSANZ

    Food Standards Australia New Zealand (formerly ANZFA).

    FSC

    Food Standards Committee.

    FSD

    Food Supplements Directive.

    FSIS

    Food Safety and Inspection Service.

    FSO

    Food Safety Objective.

    FSSAI

    Food Safety and Standards Authority of India.

    fT

    Food-type distribution factor.

    FT-IR

    Fourier Transform Infrared.

    FVO

    Food and Veterinary Office.

    GA

    Glutamic Acid.

    GABA

    Gamma-Aminobutyric Acid.

    GAPs

    Good Agricultural Practices.

    GATT

    General Agreement on Tariffs and Trade.

    GC

    Gas Chromatography.

    GCC

    Gulf Cooperation Council.

    GC/MS

    Gas Chromatography/Mass Spectrometry.

    GCS

    g-glutamylcysteine synthetase.

    GDP

    Gross Domestic Product.

    GFL

    General Food Law.

    GFSI

    Global Food Safety Initiative.

    GHI

    Global Harmonization Initiative.

    GHPs

    Good Hygienic Practices (also Good Hygiene Practices).

    GI

    Gastrointestinal.

    GLPs

    Good Laboratory Practices.

    GM

    Genetically Modified.

    GMO

    Genetically Modified Organism.

    GMC

    Common Market Group (Grupo Mercado Común, Spanish).

    GMP

    Disodium 5′-Guanosine Monophosphate.

    GMPs

    Good Manufacturing Practices.

    GRAS

    Generally Recognized As Safe.

    GSFA

    General Standard for Food Additives.

    GSH

    Glutathione.

    HAA

    Heterocyclic Aromatic Amine.

    HACCP

    Hazard Analysis Critical Control Point.

    HBL

    Hemolysin BL.

    HCN

    Hydrogen cyanide (hydrocyanic acid).

    HDL

    High-Density Lipoprotein.

    HEATOX

    Heat-generated food toxicants, identification, characterization and risk minimization.

    HFFA

    Health/Functional Food Act.

    HFFs

    Health/Functional Foods.

    HHP

    High Hydrostatic Pressure.

    HHS

    Department of Health and Human Services.

    HMPA

    Hexamethylphosphoramide.

    HPP

    High Pressure Processing.

    HPP

    Hydrolyzed Protein Product.

    HPRT

    Hypoxanthine Phosphoribosyltransferase

    HPS

    Health Physics Society.

    HT-2

    HT-2 toxin.

    IARC

    International Agency for Research on Cancer.

    ICC

    International Association for Cereal Science and Technology (formerly International Association for Cereal Chemistry).

    ICMSF

    International Commission on Microbiological Specifications for Foods.

    IDB

    Inter-American Development Bank.

    IDF

    International Dairy Federation.

    IEC

    International Electrotechnical Commission.

    IFIC

    International Food Information Council.

    IFS

    International Food Standard.

    IFT

    Institute of Food Technologists.

    Ig

    Immunoglobulin.

    IHR

    International Health Regulations.

    IMACE

    International Margarine Association of the Countries of Europe.

    IMF

    International Monetary Fund.

    IMP

    Disodium 5′-Inosine Monophosphate.

    INFOSAN

    International Food Safety Authorities Network.

    INTI

    National Institute of Industrial Technology.

    INTN

    National Institute of Technology and Standardization.

    INU

    Intended Normal Use.

    IOM

    Institute of Medicine.

    IPCC

    Intergovernmental Panel on Climate Change.

    IPCS

    International Programme on Chemical Safety.

    IQ

    2-amino-3-methylimidazo[4,5-f]quinoline.

    IPPC

    International Plant Protection Convention.

    IRAM

    Argentine Standardization Institute (Instituto Argentino de Normalización y Certificación, formerly Instituto Argentino de Racionalización de Materiales, Spanish).

    ISI

    Indian Standards Institution.

    ISO

    International Organization for Standardization.

    ISR

    International Sanitary Regulations.

    ITU

    International Telecommunication Union.

    IUFoST

    International Union of Food Science and Technology.

    IVO

    Iran Veterinary Organization.

    JECFA

    Joint FAO/WHO Expert Committee on Food Additives.

    JEMRA

    Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment.

    JETRO

    Japan External Trade Organization.

    JFDA

    Jordan Food and Drug Administration.

    JHAVC

    Japan Hygienic Association of Vinylidene Chloride.

    JHOSPA

    Japan Hygienic Olefin and Styrene Plastics Association.

    JMPR

    Joint FAO/WHO Meetings on Pesticide Residues.

    JRC

    Joint Research Centre.

    KFDA

    Korea Food and Drug Administration.

    KFT

    Karl Fischer Titration.

    LATU

    Technological Laboratory of Uruguay (Laboratorio Tecnológico del Uruguay, Spanish).

    LbL

    Layer-by-Layer

    LC-MS-MS

    Liquid Chromatography-Mass Spectrometry-Mass Spectrometry.

    LDL

    Low-Density Lipoprotein.

    LEB

    Listeria Enrichment Broth.

    L-GA

    L-Glutamic Acid.

    LNT

    Linear Non-Threshold.

    LOAEL

    Lowest-Observed-Adverse-Effect-Level.

    LOD

    Limit of Detection.

    LOQ

    Limit of Quantitation.

    LPM

    Lithium Chloride-Phenylethanol-Moxalactam.

    LT

    Linear Threshold.

    M/S

    ratio (mass of food stuff contained/contact surface area of FCM)

    MALDI-MS

    Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry.

    MC

    Microbiological Criteria.

    MeIQ

    2-amino-3,4-dimethylimidazo[4,5-f] quinoline.

    MeIQX

    2-amino-3,8-dimethylimidazo[4,5-f] quinoline.

    MERCOUSUL

    Common Market of the South (Mercado Commum do Sul, Portuguese).

    MERCOSUR

    Common Market of the South (Mercado Común del Sur, Spanish).

    MDG

    Millennium Development Goal.

    MED.

    Minimum Effective Dose.

    mGST-1

    microsomal Glutathione-S-Transferase.

    MHLW

    Ministry of Health, Labour and Welfare.

    ML

    Maximum Level.

    MLA

    McBride Listeria Agar.

    MN

    Micronuclei.

    MoA

    Ministry of Agriculture (India).

    MOA

    Ministry of Agriculture (Japan).

    MoC

    Ministry of Commerce.

    MoCA

    Ministry of Consumer Affairs.

    MoFPI

    Ministry of Food Processing Industries.

    MoHFW

    Ministry of Health and Family Welfare.

    MOHWF

    Ministry of Health, Welfare and Family Affairs.

    MOU

    Memorandum of Understanding.

    MOXA

    Modified Oxford Agar.

    MPA

    Medroxyprogesterone acetate.

    MPN

    Most Probable Number.

    MPPO

    Modified Polyphenylene Oxide.

    MRC

    Medical Research Council.

    MRL

    Maximum Residue Limit.

    MRPL

    Minimum Required Performance Limit.

    mRNA

    Messenger Ribonucleic Acid.

    MRSA

    Methicillin-resistant Staphylococcus aureus.

    M/S

    ratio (mass of foodstuff contained/contact surface area of FCM).

    MSG

    Mono-Sodium Glutamate.

    MTR

    Maximum Tolerable Risk.

    NAFTA

    North American Free Trade Agreement.

    NASA

    National Aeronautics and Space Administration.

    NAT

    N-acetyl transferase.

    NAT 1

    N-acetyl transferase 1.

    NCFST

    National Center for Food Safety and Technology.

    NCTR

    National Center for Toxicological Research.

    ND

    Not Detected/Not Detectable.

    NEPA

    National Environmental Policy Act.

    NFA

    National Food Authority.

    NFP

    Nutrition Facts Panel.

    NGFIS

    Netherlands Government Food Inspection Service.

    NGOs

    Non-Governmental Organizations.

    NHE

    Non-Hemolytic Enterotoxin.

    NHMRC

    National Health and Medical Research Council.

    NIAS

    Non-Intentionally Added Substances.

    NIOSH

    National Institute for Occupational Safety and Health.

    NIP

    Nutrition Information Panel.

    NIR

    Near Infrared.

    NLEA

    Nutrition Labeling and Education Act.

    NMDA

    N-methyl-D-aspartate.

    NMSP

    Nanoscale Materials Stewardship Program.

    NNI

    National Nanotechnology Initiative.

    NOAEL

    No-Observed-Adverse-Effect-Level.

    NOEL

    No-Observed-Effect-Level.

    NordVal

    Nordic System for Validation of Alternative Microbiological Method.

    NRC

    National Research Council.

    NRCS

    National Regulator for Compulsory Specifications.

    nRDA

    New Recommended Daily Allowance.

    NRV

    Nutrient Reference Value.

    NSW

    New South Wales.

    NTP

    National Toxicology Program.

    OAS

    Organization of American States.

    OD

    Oven Drying.

    OECD

    Organisation for Economic Co-operation and Development.

    OIE

    World Organisation for Animal Health (formerly Office International des Epizooties, French).

    OLF

    Other Legitimate Factor.

    OMA

    Official Methods of Analysis.

    OML

    Overall Migration Limit (expressed in mg/kg or mg/dm2) (EU and MERCOSUR (=LMT, Límite de Migración Total, Spanish)).

    OSHA

    Occupational Safety and Health Administration.

    OTA

    Ochratoxin A.

    OWCs

    Organic Wastewater Contaminants.

    OXA

    Oxford Agar.

    PA

    Polyamide.

    PAHO

    Pan American Health Organization.

    PALCAM

    Polymyxin Acriflavine Lithium chloride Ceftazidime Aesculin Mannitol.

    PAS

    Publicly Available Specification.

    PATP

    Pressure Assisted Thermal Processing.

    PC

    Polycarbonate.

    PCBs

    Polychlorinated biphenyls.

    PCDDs

    Polychlorinated dibenzodioxins.

    PCDFs

    Polychlorinated dibenzofurans.

    PCR

    Polymerase Chain Reaction.

    PE

    Polyethylene.

    PEF

    Pulsed Electric Fields.

    PEMBA

    Polymyxin pyruvate egg-yolk mannitol bromothymol blue agar.

    PEN

    Project on Emerging Nanotechnologies.

    PET

    Polyethylene Terephthalate.

    PFA

    Prevention of Food Adulteration Act.

    PFAC

    Pure Food Advisory Committee.

    PFGE

    Pulsed Field Gel Electrophoresis.

    PhIP

    2-amino-1-methyl-6-phenylimidazo [4,5-b]pyridine.

    PLA

    Polylactic Acid.

    PMMA

    Polymethyl Metracrylate.

    PMP

    Poly(4-methyl-1-pentene).

    PO

    Performance Objective.

    POPs

    Persistent Organic Pollutants.

    PP

    Polypropylene.

    ppb

    parts per billion (1 in 10⁹).

    PPCPs

    Pharmaceuticals and Personal Care Products.

    ppm

    parts per million (1 in 10⁶).

    ppt

    parts per trillion (1 in 10¹²).

    PRC

    People’s Republic of China.

    PRPs

    Prerequisite Programs.

    PS

    Polystyrene.

    PTDI

    Provisional Tolerable Daily Intake.

    PTH

    Parathyroid Hormone.

    PTI

    Provisional Tolerable Intake.

    PTMI

    Provisional Tolerable Monthly Intake.

    PTWI

    Provisional Tolerable Weekly Intake.

    PVA

    Polyvinyl Alcohol.

    PVC

    Polyvinyl Chloride.

    PVDC

    Polyvinylidene Chloride.

    QM

    Quantity in Material (limit on the residual quantity of a substance left in the finished material expressed in mg/kg) (EU and MERCOSUR (=LC, Límite de Composición, Spanish)).

    QMA

    Quantity in Material per surface Area (limit on the residual quantity of a substance left in the finished material expressed as mg per 6 dm2 of the surface in contact with the food) (EU and MERCOSUR (=LCA, Límite de Composición por Area de superficie de contacto, Spanish)).

    QMA(T)

    group concentration limit (limit on the residual quantity left in the finished material expressed as mg of total of moiety or substance(s) indicated per 6 dm2 of the surface in contact with the food) (EU and MERCOSUR (=LCA(T), Límite de Composición grupal por Area de superficie de contacto, Spanish)).

    QM(T)

    group concentration limit (limit on the residual quantity left in the finished material expressed as total of moiety or substance(s) indicated, in mg/kg) (EU and MERCOSUR (=LC(T), Límite de Composición grupal, Spanish)).

    QMRA

    Quantitative Microbiological Risk Assessment.

    RAPD

    Randomly Amplified Polymorphic DNA.

    RASFF

    Rapid Alert System for Food and Feed.

    RD

    Reference Drying.

    R&D

    Research and Development.

    RDAs

    Recommended Daily Allowances (also Recommended Dietary Allowances).

    RDIs

    Reference Daily Intakes (also Recommended Daily Intakes).

    RF

    Russian Federation.

    RFLP

    Restriction Fragment Length Polymorphism.

    RIA

    Radioimmunoassay.

    RIVM

    National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, Dutch).

    RNA

    Ribonucleic Acid.

    ROS

    Reactive Oxygen Species.

    RPHA

    Reverse Passive Haemagglutination.

    RPLA

    Reverse Passive Latex Agglutination.

    rRNA

    Ribosomal Ribonucleic Acid.

    RTE

    Ready-To-Eat.

    RTQ

    Real-Time Quantitative.

    S/M

    ratio (contact surface area of FCM/mass of foodstuff or simulant

    SABS

    South African Bureau of Standards.

    SAIC

    State Administration for Industry and Commerce.

    SAIF

    Surface Adhesion Immunofluorescence.

    SARS

    Severe Acute Respiratory Syndrome

    SCENIHR

    Scientific Committee on Emerging and Newly Identified Health Risks.

    SCGE

    Single Cell Gel Electrophoresis.

    SEM

    Semicarbazide.

    SF

    Sampling Frequency.

    SFDA

    Saudi Food and Drug Authority.

    SFDA

    State Food and Drug Administration.

    SGT 3

    MERCOSUR Working Sub-Group 3 (Sub-Grupo de Trabajo 3, Spanish)

    SIG

    Special Interest Group.

    S/M

    ratio (contact surface area of FCM/mass of foodstuff or simulant).

    SML

    Specific Migration Limit (expressed in mg/kg) (EU and MERCOSUR (=LME, Límite de Migración Especifica, Spanish)).

    SML(T)

    Group Migration Limit (expressed as total of moiety or substance(s) indicated, in mg/kg) (EU and MERCOSUR (=LME(T), Límite de Migración grupal, Spanish)).

    SPC

    Standard Plate Count.

    SPM

    Scanning Probe Microscopy.

    S-PMF

    Soft Palm Mid-Fraction.

    SPS

    Sanitary and Phytosanitary Measures.

    SULs

    Safe Upper Limits.

    SULT

    Sulfotransferase.

    SVRs

    Surface-to-Volume Ratios.

    T-2

    T-2 toxin.

    TAA

    Total Antioxidant Activity.

    TB

    Tuberculosis.

    TBS

    Tanzania Bureau of Standards.

    TBT

    Technical Barriers to Trade.

    TC

    Technical Committee.

    TCDD

    2,3,7,8-tetrachlorodibenzo-para-dioxin.

    TDI

    Tolerable Daily Intake.

    TD-NMR

    Time-Domain Nuclear Magnetic Resonance.

    TEQ

    Toxic Equivalent.

    TFA

    Trans Fatty Acids.

    TFDA

    Tanzania Food and Drugs Authority.

    TFS

    Tin-Free Steel also see ECCS.

    TIE

    Toxicologically Insignificant Exposure.

    TMI

    Tolerable Monthly Intake.

    TNase

    Thermostable (heat-resistant) nuclease.

    TNC

    Transnational Corporation.

    TOR

    Threshold of Regulation.

    TP

    Total Polyphenol.

    TRF

    Total Reduction Factor.

    Trp-P-1

    3-amino-1,4-dimethyl-5H-pyrido [4,3-b]indole.

    Trp-P-2

    3-amino-1-methyl-5H-pyrido [4,3-b]indole.

    TRIPS

    Trade-Related Aspects of Intellectual Property Rights.

    TTC

    Threshold of Toxicological Concern.

    TTMRA

    Trans-Tasman Mutual Recognition Arrangement.

    UAE

    United Arab Emirates.

    UBSL

    Universally Banned Substances List.

    UDPGT

    UDP-glucuronosyl transferase.

    UF

    Uncertainty Factor.

    UGT

    Glucuronosyltransferase.

    UK

    United Kingdom.

    UN

    United Nations.

    UNECA

    United Nations Economic Commission for Africa.

    UNFPA

    United Nations Population Fund (formerly United Nations Fund for Population Activities).

    UNIDO

    United Nations Industrial Development Organization.

    UNWTO

    United Nations World Tourism Organization.

    URAA

    Uruguay Round Agreement on Agriculture.

    US/USA

    United States (of America).

    USC

    United States Code.

    USDA

    United States Department of Agriculture.

    US RDAs

    US Recommended Daily Allowances.

    UV

    Ultraviolet.

    UVB

    Ultraviolet B.

    UVM

    University of Vermont.

    VCM

    Vinyl Chloride Monomer.

    WC

    Water Content.

    WEF

    World Economic Forum.

    WFS

    World Food Summit.

    WG

    Working Group.

    WHO

    World Health Organization.

    WTO

    World Trade Organization.

    Contributors

    Fadwa Al-Taher

    Illinois Institute of Technology National Center for Food Safety and Technology, Summit-Argo, IL, USA

    Lucia E. Anelich

    Consumer Goods Council of South Africa, Craighall, South Africa

    Kalapanda M. Appaiah

    Retired Head, Food Safety and Analytical Quality Control Laboratory, Central Food Technological Research Institute, Mysore, India

    Alejandro Ariosti

    INTI (National Institute of Industrial Technology), Plastics Center, Buenos Aires, Argentina

    Janis Baines

    Food Standards Australia New Zealand, Canberra BC ACT, Australia

    Gustavo V. Barbosa-Canovas

    Center for Nonthermal Processing of Food, Washington State University, Pullman, WA, USA

    Daniela Bermúdez-Aguirre

    Center for Nonthermal Processing of Food, Washington State University, Pullman, WA, USA

    Christine E. Boisrobert

    Air Liquide, Houston, TX USA

    Hans Bouwmeester

    RIKILT - Institute of Food Safety, Wageningen UR, Wageningen, The Netherlands

    Adelia C. Bovell-Benjamin

    Department of Food and Nutritional Sciences, Tuskegee University, Tuskegee, AL, USA

    Paul Brent

    Food Standards Australia New Zealand, Canberra BC ACT, Australia

    Julie Larson Bricher

    National Center for Food Safety and Technology, Illinois Institute of Technology, International Commission on Microbiological Specifications for Foods, Summit-Argo, IL, USA

    Elaine Bromfield

    Department of Food and Nutritional Sciences, Tuskegee University, Tuskegee, AL, USA

    Frank F. Busta

    University of Minnesota, St. Paul, MN, USA

    Martin Cole*

    National Center for Food Safety and Technology, Illinois Institute of Technology, Summit-Argo, IL, USA

    *On behalf of The International Commission on Microbiological Specifications for Foods (www.icmsf.org)

    Pamela L. Coleman

    Silliker, Inc., Homewood, IL, USA

    Firouz Darroudi

    Department of Toxicogenetics, Leiden University Medical Centre, Leiden, The Netherlands

    Thibaut Dubois

    Department of Toxicogenetics, Leiden University Medical Centre, Leiden, The Netherlands

    Veronika Ehrlich

    Institute of Cancer Research, Department of Medicine I, Medical University of Vienna, Vienna, Austria

    Anthony J. Fontana

    Silliker, Inc., Homewood, IL, USA

    Neal D. Fortin

    Institute for Food Laws & Regulations, Michigan State University, East Lansing, MI, USA

    Tracy Hambridge

    Food Standards Australia New Zealand, Canberra BC ACT, Australia

    Jaap C. Hanekamp

    Roosevelt Academy, Middelburg, HAN-Research, Zoetermeer, The Netherlands

    Vincent Hegarty

    Institute for Food Laws & Regulations, Michigan State University, East Lansing, MI, USA

    Heinz-Dieter Isengard

    University of Hohenheim, Institute of Food Science and Biotechnology, Stuttgart, Germany

    Lauren S. Jackson

    US Food and Drug Administration, National Center for Food Safety and Technology, Summit-Argo, IL

    Edward Jansson

    The New South Wales Food Authority, Silverwater NSW, Australia

    Frans W.H. Kampers

    Wageningen UR, Wageningen, The Netherlands

    Larry Keener

    International Product Safety Consultants, Seattle, WA, USA

    Ji Yeon Kim

    Division of Nutrition and Functional Food, Bureau of Nutrition and Functional Food, Korea Food & Drug Administration, Seoul, Korea

    Siegfried Knasmüller

    Institute of Cancer Research, Department of Medicine I, Medical University of Vienna, Vienna, Austria

    Gisela Kopper

    University of Costa Rica, San José, Costa Rica

    Jan H.J.M. Kwakman

    President-Seafood Importers and Processors Alliance

    Oran Kwon

    Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, Korea

    Huub L.M. Lelieveld

    Formerly Unilever R & D, Vlaardingen, The Netherlands

    Rebeca López-García

    Logre International Food Science Consulting, México, DF, México

    Volker Mersch-Sundermann

    Department of Environmental Health Sciences, Freiburg University Medical Centre, Freiburg, Germany

    David Miles

    The New South Wales Food Authority, Silverwater NSW, Australia

    Carmen Moraru

    Department of Food Science, Cornell University, Ithaca, NY, USA

    Sangsuk Oh

    Department of Food Science and Technology, Ewha Womans University, Seoul, Korea

    William R. Porter

    New South Wales Food Authority, Newington, NSW, Australia

    Margherita Poto

    University of Torino, Italy; Wageningen University, The Netherlands; and the African Institute for Comparative and International Law, Songea, Tanzania

    V. Prakash

    Director, Central Food Technological Research Institute, Mysore, India

    Keith C. Richardson

    Food Science Australia, North Ryde, NSW, Australia

    Syed S.H. Rizvi

    Department of Food Science, Cornell University, Ithaca, NY, USA

    Vijay D. Sattigeri

    Central Food Technological Research Institute, Mysore, India

    Bert Schwitters

    International Nutrition Company, Loosdrecht, The Netherlands

    Mun-Gi Sohn

    Korea Food & Drug Administration, Seoul, Republic of Korea

    Glenn Stanley

    Food Standards Australia New Zealand, Canberra BC ACT, Australia

    Cynthia M. Stewart

    Silliker, Food Science Center, South Holland, IL, USA

    Juanjuan Sun

    Law School at Shantou University and future PhD student of Law School at Nantes University

    John G. Surak

    Surak and Associates, Clemson, SC, USA

    Elizabeth A. Szabo

    The New South Wales Food Authority, Silverwater NSW, Australia

    Martinus AJS (Tiny) van Boekel

    Wageningen University & Research Centre, Product Design & Quality Management Group, Wageningen, The Netherlands

    Bernd van der Meulen

    Wageningen University and European Institute for Food Law, Wageningen, The Netherlands

    Mandyam C. Varadaraj

    Department of Human Resource Development, Central Food Technological Research Institute, Mysore, India

    Yuriy Vasilyev

    Director of the Stavropol Branch of the North Caucasus Civil Service Academy; and Head of the Law department at the Stavropol Stage Agricultural University, Russian Federation

    Axelle Wuillot

    Department of Toxicogenetics, Leiden University Medical Centre, Leiden, The Netherlands

    Chapter 1. Ensuring Global Food Safety—A Public Health Priority and a Global Responsibility

    Julie Larson Bricher

    National Center for Food Safety and Technology, Illinois Institute of Technology, International Commission on Microbiological Specifications for Foods, Summit-Argo, IL, USA

    ‘Only if we act together can we respond effectively to international food safety problems and ensure safer food for everyone.’

    —Dr. Margaret Chan, Director-General, World Health Organization

    The march toward globalization appears inexorable, even as the trend remains politically controversial on the world stage. The International Monetary Fund defines globalization as ‘the process through which an increasingly free flow of ideas, people, goods, services, and capital leads to the integration of economies and societies’ (IMF, 2006). At its core, globalization is a process driven by free trade economics and an ideal driven by the promise of greater societal benefits for all peoples of the world. Proponents put forward that an economy without borders spurs greater market competition and therefore economic freedom, driving down prices and increasing availability and variety of affordable goods and services for a greater number of people. In turn, globalization promises further benefits, such as increases in productivity, access to new technologies and information streams, and higher living, environmental and labor standards for those in both developed and developing countries. Critics charge that inherent economic and infrastructure inequalities that exist between developed and developing nations preclude less developed and poorer nations from fully realizing these benefits.

    Some socioeconomic benefits of an interconnected world market have been realized in countries such as China, India and Vietnam, where poverty rates have substantially declined in concert with more liberalized international trade policies. However, whatever the measurable positive benefits experienced by some countries over the years, there are also tangible challenges brought on by the rapid acceleration of globalization in the world economy. The agro-food production and distribution supply chain is a key case in point. Nearly a decade into the twenty-first century, the challenges of ensuring food security, food safety and nutrition on a global scale continue to grow in complexity. Recent statistics show that the levels of world hunger, malnutrition, and food and waterborne disease are among the most critical global public health issues facing the international community. For example:

    • According to a 2008 report on international food security by the Food and Agriculture Organization (FAO) of the United Nations, 963 million people are undernourished, up from 923 million in 2007 (FAO, 2008).

    • Although world food prices have stabilized, FAO officials report that lower prices have not ended the food crisis in developing countries, raising concerns about the feasibility of reaching the World Food Summit goal to reduce the number of world’s hungry by 50% by 2015 (FAO, 2008; World Food Summit, 1996).

    • The World Health Organization (WHO) reports that foodborne diarrhoeal disease is one of the most common illnesses worldwide, estimated at between 2.2 and 4 million cases per year (WHO, 2004; Schlundt, 2008).

    • Each day, thousands of people die from preventable foodborne disease. In developing countries, 1.8 million children under the age of five die each year because of diarrhoeal diseases. Up to 70% of these cases may be caused by foodborne pathogens (WHO, 2004; Schlundt, 2008).

    • In developed countries, one in three consumers gets a foodborne disease associated with microbes or their toxins every year. This does not include other foodborne diseases associated with naturally-occurring or man-made chemical contaminants, such as aflatoxin, acrylamide, furan or dioxin (Schlundt, 2008).

    The WHO Initiative to Estimate the Global Burden of Foodborne Diseases identifies the rapid globalization of food trade as a worldwide trend that has introduced an increased potential for contaminated food to adversely affect greater numbers of people (WHO, 2004). As the food supply chain becomes more integrated, the potential for massive foodborne illness outbreaks caused by pathogens, chemicals, viruses and parasites increases—as do the difficulties in controlling foodborne infections, morbidity, disability and mortality. Rapid globalization also has exposed critical gaps in national and international capabilities to assure adequate levels of food safety and quality. Disparities related to national infrastructural and technological capacities and international food production, distribution and handling standards and law have become more visible as global commerce becomes more interconnected. As a result, WHO and other food-related international public health, development and standard-setting bodies have targeted these gaps as priority items and are working together to reinforce the need to use an integrated international food safety regulatory system in the era of ‘one global market.’ To be effective, these organizations agree that such a system must include: 1) advancing the use of risk analysis and management to better direct resources towards areas of high risk; 2) providing a scientific basis for international food safety action; 3) moving from conventional ‘vertical’ legislation within nations to more ‘horizontal’ rulings among nations to attain harmonization of standards and reduce barriers to trade; and 4) building capacity to promote the availability and use of new food safety technologies, testing and prevention strategies that will reduce the public health risks of foodborne disease around the globe.

    In this book, members of the Global Harmonization Initiative (GHI) contribute to the world dialogue, discussing tools for promoting harmonization of scientific methods, standards and regulations. Launched in 2004, GHI is a network of international scientific organizations and individual scientists that aims to achieve objective consensus on the science of food regulations and legislation to ensure the global availability of safe and wholesome food products for all consumers. With support and participation of its individual members and member organizations, GHI has conducted a series of meetings at which members have formulated approaches to critically (re-)evaluate the scientific evidence used to underpin existing global regulations in the areas of product composition, processing operations, and technologies or measures designed to prevent foodborne illness. The chapters in this book address the differences between existing regulations and illustrate why they need to be aligned in concert with efforts from international public health and food safety authorities, including WHO, FAO, and the Codex Alimentarius Commission (CAC).

    GHI’s overarching objective is to provide regulators, policymakers and public health authorities with a foundation for sound, sensible, science-based international regulations in order to eliminate hurdles to scientific advancement in food safety technology. For example, there is no question that, the more avenues of global trade narrow, the higher the probability of traffic jams in worldwide commerce. Barriers to trade in the form of differing—and sometimes conflicting—country-by-country import/export rules and requirements, can and do make it difficult for food businesses to get traction in overseas markets. Food safety concerns are frequently cited by individual nations as underpinning the justification for their legislative acts and rulemaking—and for erecting trade barriers and other measures that have the impact of curtailing free trade. Unfortunately, in some cases, the science used to inform and bolster food safety policymaking is insufficient, inconsistent or contradictory, creating a roadblock to the promulgation of laws that have a clear and evident benefit to protecting public health. National differences in food safety regulations and laws also trigger a red light to the advances offered by science and technology. Though many food companies throughout the world have invested significant monies in food safety and nutrition technology research and development efforts, industry is understandably hesitant to apply newly-developed capabilities on an international scale in an uncertain, maze-like regulatory environment.

    By streamlining international regulations, laws and standards, GHI expects that the private sector will find it increasingly beneficial to invest in food safety and nutrition research and development, making individual nations' food industries more competitive in the world market. Legislative harmonization will also spur the adoption and use of innovative technologies, which in turn will raise industry’s confidence in investing corporate funds and other resources in technologies that will further ensure the safety, quality and security of the global food supply.

    Ultimately, ‘globalizing’ food safety regulations and laws based on sound science can only serve to help bridge public health gaps and create opportunities for all stakeholders to realize the big-picture benefits promised by economic globalization, including measurable global reductions in morbidity and mortality associated with foodborne disease; increases in food availability to combat malnutrition and enhance food security for consumers worldwide; and decreases in poverty rates among less-developed or impoverished nations through capacity building that enables full participation in the global economy. For public health agencies responsible for overseeing the safety of the international food supply, harmonization of food safety and quality standards and regulations will bring a higher level of confidence that risk-reduction strategies and food safety measures are effective, that decisions taken are based on science and not on underlying political agendas that may be in conflict with public health goals, and that available resources are allocated where they have the highest impact on the most pressing food disease-related problems.

    To paraphrase WHO Director-General Chan, only if we act together can we fully embrace our global responsibility to respond effectively to the challenges of ensuring food security, food safety and nutrition for everyone. As the authors in this book attest, meeting that global responsibility requires co-operation, collaboration and consensus-building if we are to achieve harmonization of food regulations and standards, and thereby accomplish even greater gains in ensuring global public health.

    References

    Chapter 2. Development of Food Legislation Around the World¹

    ¹Bernd van der Meulen is professor of Law and Governance at Wageningen University (The Netherlands). See < www.law.wur.nl>. He took responsibility for integrating the contributions to this chapter and wrote the sections on international food law and on the EU. These sections elaborate on his contributions to the European Food Law Handbook. Comments are welcome at: < Bernd.vanderMeulen@wur.nl>.

    2.1. Introduction

    Bernd M.J. van der Meulen

    Wageningen University, The Netherlands

    2.1.1. We Always Eat

    Eating and drinking are among the few things that, without a single exception, everyone does. A custom we share with all our contemporaries and ancestors. It is obvious that where a concept of law is developed it will quickly lead to rules related to the acquiring and distributing of food. German introductory literature (for example, Lips & Beutner, 2000) on food law likes to refer to the discovery of a Phoenician inscription that dates back to 1000 BC. Some believe this the oldest food regulation still in our possession. ² It reads: ‘Thou shall not cast a spell on thy neighbor’s wine’.

    ²This is debatable, however. The famous Babylonian Code of Hammurabi is about a millennium older and also holds provisions that may be understood to relate to the adulteration of food.

    There is, however, much more law than just statutory regulations. Echoes of food law resound from an even more distant past. The oldest pieces of writing, for instance, that remain of Pharaonic Egypt are food labels (Seidlmayer, 1998). They date back to the first dynasty, i.e. 3000 BC. Archaeologists are very fond of labels as they provide a wealth of information on many different aspects of a culture. They contain at least three types of texts: names of products, ³ specifications of quantities⁴ and dates. ⁵ For lawyers it is just a small step to suspect a general rule behind the label stipulating that the product, quantity and date stated must be correct. It does not matter whether that general rule has been issued by a ruler, has a religious origin or is rooted in the conviction of the parties concerned that this is as it should be. All constitute a source of law and thus a rule of law. Of course we do not know what the consequences were of violation of that rule of law. Were there sanctions? Could a buyer return an improperly labeled product?

    ³They provide information on language.

    ⁴They provide information on measurements and weights.

    ⁵They provide information on chronology—crucial to archaeologists.

    The role of the authorities in ancient Egyptian food law is also unknown. The Bible-book of Genesis⁶ shows that a vice-pharaoh who in times of plenty had stores laid up to feed his people in the years of famine was regarded as extremely wise. It seems that concern for his people, although appreciated, was not one of the standard responsibilities of a ruler.

    ⁶Genesis 41: 37–57.

    2.1.2. Food and Values

    In modern time food is recognized as a human right. The right to adequate food is mentioned in the Universal Declaration on Human Rights (Article 25) and laid down in several international treaties of which the Internation-al Covenant on Economic, Social and Cultural Rights (Article 11) is probably the most important. International organizations such as the Food and Agriculture Organization (FAO) and the UN Committee on Economic, Social and Cultural Rights have further elaborated this right. ⁷ The right to adequate food is realized if people have access to food that:

    ⁷See for example the Voluntary Guidelines to support the progressive realisation of the right to adequate food in the context of national food security: < http://www.fao.org/docrep/meeting/009/y9825e/y9825e00.htm>.

    – provides sufficient nutritional value and micronutrients for a person to lead a healthy and active life;

    – is free of hazardous substances;

    – is acceptable within a given culture.

    Rights always go hand in hand with obligations. Human rights go hand in hand with state obligations. Regarding the right to food three types of obligations are distinguished:

    1. The obligation to respect. In general people are able to care for themselves and their families. This ability may not be curbed without sound legal justification; this is in line with other fundamental rights such as the freedom of expression for instance.

    2. The obligation to protect. If the ability of citizens to provide for themselves is threatened by other citizens the government must do its best to protect these citizens from the others.

    3. The obligation to fulfill. This obligation is composed of a policy obligation and a relief obligation. On the one hand a prudent government is expected to adopt policy geared towards supporting and promoting the ability of the population to provide for itself, on the other hand it must do its best to provide assistance if people find themselves in a situation in which they cannot provide for themselves through no fault of their own.

    Here below we will see that it is mainly the second aspect of adequate food (safety) and the second state obligation (to protect) that is taken up in the food regulatory systems as we find them today in all over the world.

    2.1.3. This Chapter

    Legislation on food is not only widely distributed in time, but also in space. We may expect to find law relating to food in all corners of the globe. This book is not a place to attempt a systematic overview. In this chapter a variety of systems are presented (International, India, South Africa, Eastern Africa, Australia and New Zealand, United States of America, Canada, Latin America, the EU, the Near East, Northeast Asia, China and the Russian Federation) in the perspective of their development to give an impression of the features found in food law and the reasons why they have taken certain forms. Each section has its own separate author or authors, indicated at its beginning. The authors have based their contributions on an open question to present highlights in development, not on strict guidelines. Personal differences in style and approach of the subject matter have been respected.

    In the systems presented we repeatedly find a complex situation due in part to the distribution of the subject matter over different competent authorities. We find product specific provisions alongside legislation of a more general nature. In all systems presented here, safety is an important consideration for the legislators concerned who increasingly rely on science. Repeatedly reference is made to international developments and standards such as the Codex Alimentarius. For this reason this chapter opens with a section introducing international food law as a background to the national and regional systems discussed thereafter.

    2.2. International Food Law

    Bernd M.J. van der Meulen

    Wageningen University, The Netherlands

    2.2.1. Codex Alimentarius

    In 1961 the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) established the Codex Alimentarius Commission (CAC). Over the years the CAC has established specialized committees. These committees are hosted by member states all over the world. Some 175 countries, representing about 98% of the world’s population, participate in the work of Codex Alimentarius.

    Food standards are established through an elaborate procedure of international negotiations (FAO/WHO, 2006). All standards taken together are called ‘Codex Alimentarius’. In Latin this means ‘food code’. It can be seen as a virtual book filled with food standards. The food standards represent models for national legislation on food.

    Beside the food standards, Codex Alimentarius includes advisory provisions called codes of practice or guidelines. These codes of practice and guidelines mainly address food businesses.

    At present the Codex comprises more than 200 standards, close to 50 food hygiene and technological codes of practice, some 60 guidelines, over 1,000 food additives and contaminants evaluations and over 3,200 maximum residue limits for pesticides and veterinary drugs. Finally, the Codex Alimentarius includes requirements of a horizontal nature on labeling and presentation and on methods of analysis and sampling (FAO/WHO (2002) and FAO/WHO (2006); Masson-Matthee, 2007).

    2.2.2. Procedural Manual

    The ‘constitution’ of the Codex Alimentarius is the Procedural Manual. The Procedural Manual not only gives the procedures and format for setting Codex Standards and Guidelines, but also some general principles and definitions (Table 2.1). The principles relate among other things to the scientific substantiation of the work of Codex Alimentarius and the use of risk analysis for food safety (Table 2.2).

    2.2.3. Standards

    The work of the CAC has resulted in a vast collection of internationally agreed food standards that are presented in a uniform format. Most of these standards are of a vertical (product specific) nature. They address all principal foods, whether processed, semi-processed or raw. Standards of a horizontal nature are often called ‘general standards’, like the General Standard for the Labeling of Pre-packaged Foods.

    ⁸CODEX STAN 1-1985 (Rev. 1-1991).

    According to this general standard, the following information shall appear on the labeling of pre-packaged foods:

    • the name of the food; this name shall indicate the true nature of the food;

    • list of ingredients (in particular if one of a list of 8 allergens is present);

    • net contents;

    • name and address of the business;

    • country of origin where omission could mislead the consumer;

    • lot identification;

    • date marking and storage instructions;

    • instructions for use.

    2.2.4. Codes

    In addition to the formally accepted standards the Codex includes recommended provisions called codes of practice or guidelines. There is, for example, a ‘Code of Ethics for International Trade in Food’, ⁹ and a set of hygiene codes like the ‘Recommended International Code of Practice General Principles of Food Hygiene’ and the ‘Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application’ (Table 2.3).

    ⁹CAC/RCP 20-1979 (Rev. 1-1985).

    2.2.5. Legal Force

    The Codex standards do not represent legally binding norms. They present models for national legislation. Member states undertake to transform the Codex standards into national legislation. However, no sanctions apply if they do not honor this undertaking.

    By agreeing on non-binding standards, the participating states develop a common language. All states and other subjects of international law will mean the same thing; for example, when they meet to negotiate about food, they mean ‘food’ as defined in the Codex. The same holds true for ‘milk’ and ‘honey’ and all the standards that have been agreed upon. The notion of HACCP has been developed—and is understood—within the framework of Codex Alimentarius. ¹⁰ In this way the Codex Alimentarius provides a common frame of reference, but there is more.

    ¹⁰Recommended International Code Of Practice General Principles Of Food Hygiene CAC/RCP 1-1969, Rev. 3-1997, Amd. (1999).

    The mere fact that national specialists on food law enter into discussion on these standards will influence them in their work at home. A civil servant drafting a piece of legislation will look for examples. As regards food s/he will find examples in abundance in the Codex. In these subtle ways the Codex Alimentarius is likely to have a major impact on the development of food law in many countries even without a strict legal obligation to implement.

    It turns out more than once that soft law has a tendency to solidify. Once agreements are reached, parties tend to put more weight on them than was initially intended. This is true for Codex standards as well. Due to several developments they are well on their way to acquiring at least a quasi-binding force.

    2.2.6. World Trade Organization/Sanitary and Phytosanitary Agreement

    The World Trade Organization¹¹ (WTO) tries to remove barriers to trade. To achieve this, several measures have been taken. Tariff barriers were reduced and to the extent that this was successful non-tariff barriers became more of a concern. The basic treaty addressing trade in goods is the General Agreement on Tariffs and Trade (GATT). The GATT recognizes that certain exceptions to free trade can be necessary to protect higher values like health and (food) safety.

    ¹¹Established 1 January 1995 by the Agreement Establishing the World Trade Organization as the result of the so-called Uruguay round of trade negotiations and signed in Marrakesh on 15 April 1994 (WTO Agreement). The WTO is the institutional continuation of the General Agreement on Tariffs and Trade 1947 (GATT).

    In the food trade, differences in technical standards like packaging requirements may cause problems. However, it is mostly concerns about food safety, human health, animal and plant health that induce national authorities to take measures which may frustrate the free flow of trade. To address these concerns two WTO treaties were concluded: the Agreement on Technical Barriers to Trade (the TBT Agreement) and the Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement).

    The SPS Agreement was drawn up to ensure that countries only apply measures to protect human and animal health (sanitary measures) and plant health (phytosanitary measures) based on the assessment of risk, or in other words, based on science. The SPS Agreement incorporates, therefore, safety aspects of foods in trade. The TBT Agreement covers all technical requirements and standards (applied to all commodities), such as labeling, that are not covered by the SPS Agreement. Therefore, the SPS and TBT Agreements can be seen as complementing each other.

    To a certain extent the WTO is a supranational organization. The treaties concluded between its members are binding. There is the Dispute Settlement Understanding, providing an arbitration procedure to resolve conflicts. If a party wants to present a conflict, a Dispute Settlement Body (DSB) is formed to arbitrate on the basis of WTO law. If a party does not agree with the decision of the DSB, it can take the case to an Appellate Body (AB). The WTO does not have powers to enforce decisions taken in this arbitration procedure. It can condone, however, that if the decision reached is not implemented by the party found at fault, the winning party may implement economic sanctions. These sanctions usually take the form of additional import levies on goods from the state found at fault. If the levies are condoned by the DSB (or the AB), setting them does not in itself constitute an infringement of WTO

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