Ensuring Global Food Safety: Exploring Global Harmonization
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About this ebook
- 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
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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
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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
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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
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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. ⁸
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