File #2440: "2018_Book_RegulatingAndManagingFoodSafet.pdf"
Text
1|Contents|6
1|Regulating and Managing Food Safety in the EU: A Legal-Economic Perspective|8
2|1 Introduction|8
2|2 Outline|10
3|2.1 Public-Private|10
3|2.2 Mandatory-Voluntary|11
3|2.3 Prescription-Persuasion|12
3|2.4 Rules-Principles|13
3|2.5 Ex-Ante-Ex-Post|13
3|2.6 Centralisation-Decentralisation|14
2|3 Epilogue|15
2|References|16
1|Private Food Safety Standards in the EU|17
2|1 Introduction|18
3|1.1 Characteristics of Private Food Standards|18
4|Development of Private Standards|18
4|Characteristics of Private Food Standards|20
3|1.2 Major Transnational Private Food Standards and Third Party Certification|24
2|2 Relations Between Public and Private Actors|28
3|2.1 Rule-Making|28
3|2.2 Adoption|32
3|2.3 Monitoring and Enforcement|35
3|2.4 Evaluation and Review|38
2|3 Conclusion|39
2|References|39
1|Investigating the Regulatory Structure of Voluntary Sustainability Standards: Foundations for Intervention Strategies to Incre...|44
2|1 Introduction|44
2|2 Theoretical Framework|45
2|3 Methodology|50
2|4 Results|51
3|4.1 Diversified Aim of VSSs|51
3|4.2 High NGO Involvement in Standard-Setting|52
3|4.3 Certification of Standards Often Through Private, Third-Party Certification|53
2|5 General Discussion|54
2|References|58
1|Environmental Sustainability and the Food System|61
2|1 The Concept of Sustainability|62
2|2 Issues of Environmental Sustainability of the Food System|64
2|3 Public Intervention|70
2|4 Regulatory Framework in the EU|73
3|4.1 Common Agricultural Policy|74
3|4.2 Common Fisheries Policy|75
3|4.3 Food Waste|76
3|4.4 Voluntary Measures|79
3|4.5 Private Standards|80
2|5 Consumer Perception of Environmental Sustainability and Food|81
2|6 Environmental Sustainability and Health|83
2|7 Conclusions|86
2|References|89
1|EU Health Claims: A Consumer Perspective|93
2|1 Introduction|93
2|2 A Framework for the Role of Claims and Symbols in Consumer Behaviour|95
2|3 Health Goals|96
3|3.1 Fit Between the Salient Health Goal and Products (Believed to) Satisfy it|96
3|3.2 Health Goals|97
3|3.3 Selective Attention|98
2|4 How Consumers Process Health Claims|99
3|4.1 Health Claims and Symbols in the Packaging Context|99
3|4.2 Inference Making|101
3|4.3 (Correct) Understanding of Health Claims|102
2|5 Discussion and Implications for EU Law|103
2|References|105
1|Regulatory Compliance and Company Strategies: The Case of the Nutrition and Health Claims Regulation (EC) No. 1924/2006|109
2|1 Introduction|109
2|2 A Brief Literature Review on Innovation, Regulation and the NHCR in the EU|112
3|2.1 Innovation in the EU Food Industry|112
3|2.2 Impact of Regulation on Innovation in General and for the Food Industry in Particular|114
3|2.3 The Current Status of the Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR)|115
2|3 Methods|117
2|4 The NHCR: Potential Challenges and Criticalities|117
2|5 Possible Compliance Strategies to Deal with the NHCR|121
2|6 Discussion and Conclusions|126
2|References|129
1|Foods for Specific Consumer Groups|133
2|1 Introduction|133
2|2 Protecting the Consumer Under European Food Law|135
3|2.1 Generic Safety Rules for Consumers|135
3|2.2 Generic Commercial Protection Rules for Consumers|136
3|2.3 Foods for Specific Consumer Groups in the EU|138
4|The Market of Foods for Specific Consumer Groups|138
4|Regulating Foods for Specific Consumer Groups|139
4|Innovation and Specific Food Products: Today and Tomorrow|141
2|3 Discussion|143
3|3.1 Complexities in Consumers´ Decision Making Process|144
4|Informed Choice?|144
4|Safety of Vulnerable Consumers|146
3|3.2 Complexities in the Businesses´ Decision Making Process|147
3|3.3 Case Study: The Elderly Population|149
2|4 Conclusions|151
2|References|152
1|Commanding to ``Nudge´´ via the Proportionality Principle?|155
2|1 Introduction|156
2|2 The Food Safety Goal of EU Food Law and Its Choice Architecture|157
2|3 Central Elements of the Nudging Approach|158
3|3.1 Present Biases and Structuring of Tempting Choices|160
3|3.2 Status Quo and Default Effects and Associated Nudges|160
2|4 Preference for Nudging via the Proportionality Principle?|161
2|5 Available Evidence of Effectiveness of Nudging Interventions|165
2|6 Conclusions: Applying These Insights to the Proportionality Principle|167
2|References|168
1|Obesity, Fat Taxes and Their Effects on Consumers|172
2|1 Introduction|172
2|2 Causes and Effects of Obesity: An Economic Perspective|174
3|2.1 Causes of Obesity|174
3|2.2 Effects of Obesity|176
3|2.3 Regulatory Approaches|177
2|3 Fat Taxes: Rationale and Implementations in Europe|177
3|3.1 Rationale of Fat Taxes|178
4|Is a Fat Tax an Adequate Measure to Internalize Negative Externalities?|178
4|Are Fat and Sugar Demerit Goods?|179
3|3.2 Fat Tax Implementations in the European Union|179
4|Denmark|180
4|Finland|181
4|France|181
4|Hungary|182
3|3.3 Lessons Learned from Fat Tax Implementations in Europe|183
2|4 Expected and Observed Effects of Fat Taxes on Consumers|183
3|4.1 Expected Effects|183
3|4.2 Observed Effects from Different Types of Empirical Studies|186
4|Observation Studies|186
4|Experimental Studies|189
4|Simulation Studies|191
3|4.3 Lessons Learned from Empirical Studies|192
2|5 Conclusions and Outlook|193
2|References|194
1|Substance Over Form: A Principle for European Food Information Regulation?|197
2|1 Introduction|197
2|2 Food Information Regulation and Its Principles|200
3|2.1 General Principles in the Food Information Regulation|203
4|Soft Attributes|204
4|Producers´ Rights|205
3|2.2 Formal Principles of (Food Information) Law|206
4|Coherence|207
4|Completeness|208
4|Clarity|208
2|3 Manifestations of `Fraud´|208
3|3.1 `Fraud-by-Object´|209
3|3.2 `Fraud-by Effect´|211
2|4 Substance Over Form|212
2|5 Final Remarks|215
2|References|215
1|European Food Law and the Precautionary Principle: Paradoxical Effects of the EU´s Precautionary Food Policies|218
2|1 Introduction|218
2|2 Precaution and EU Food Law|222
2|3 Antibiotic Residues in Food|223
2|4 Micro-Nutrition and Health|226
3|4.1 The Food Supplements Directive|227
3|4.2 The Nutrition and Health Claims Regulation|228
2|5 Economic Effects of Precautionary Food Policy|231
2|6 The Problems of Precautionary Food Policy Revisited|235
2|7 Conclusions|238
2|References|241
1|Enforcement of European Food Laws|246
2|1 Introduction|246
2|2 The Law and Economics of Food Law Enforcement in Europe|247
3|2.1 Sketching the Landscape|247
4|At European Level|248
4|At Member States Level|248
5|Public Law Enforcement|249
5|Private Law Enforcement|249
3|2.2 An Economic Appraisal|251
4|Private Law Enforcement|253
4|Public Law Enforcement|255
4|Interim Conclusions|258
3|2.3 Application to the European Approach|260
2|3 Conclusion|261
2|References|261
1|The Economics of Harmonization of Food Law in the EU|264
2|1 Introduction|264
2|2 Basic Economic Principles|265
3|2.1 Tiebout|265
3|2.2 Competing Legal Orders|266
3|2.3 ``Bottom up Federalism´´|267
2|3 Criteria for Harmonization of Food Law|268
3|3.1 Transboundary Externalities|268
4|General|268
4|Food|269
3|3.2 Designing Optimal Jurisdictions|270
4|General|270
4|Food|270
3|3.3 Race to the Bottom-Race to the Top|271
4|Race to the Bottom|271
5|General|271
5|Food|271
4|Race to the Top|273
5|General|273
5|Food|274
3|3.4 Internal Market|274
4|General|274
4|Food|275
3|3.5 Reducing Transaction Costs|276
3|3.6 Minimum Level of Protection|278
4|General|278
4|Food|279
3|3.7 Summary|279
2|4 Policy Consequences|280
3|4.1 Evolution of EU Food Law|280
4|From Internal Market Towards Consumer and Health Protection|281
4|The BSE-Crisis|282
4|EFSA|283
4|Incomplete Centralization|284
3|4.2 Analysis of the Hybrid System|285
2|5 Concluding Remarks|287
2|References|288
1|Pre-Market Approval and Its Impact on Food Innovation: The Novel Foods Example|292
2|1 The Concept of Novel Foods|292
3|1.1 Emerging Systems of Pre-Market Assessment of Foods and Food Ingredients|293
3|1.2 The Regulation of Novel Foods in the European Union|294
3|1.3 Practical Issues in the Application of the EU Definition of Novel Food|299
4|Product Categorisation|299
4|Borderline to Other Legal Regimes|301
4|Consumed to a Significant Degree|306
4|Novel Production Process|307
4|Additional Requirements|308
2|2 Regulatory Considerations in the Approval Process|309
3|2.1 Safety|310
3|2.2 Community Law and ``Other Legitimate Factors´´|311
2|3 Impact on Food Business Operators|314
3|3.1 The Role of Innovation for the Competitiveness of Food Manufacturers|314
3|3.2 Innovation Under the Novel Foods Regulation|316
4|Grey Areas in the Product Classification|316
5|Product Categorisation|317
5|Novel Technology in Food Production|317
5|Borderline to Other Legal Regimes|318
4|Other Requirements|320
4|Duration of the Authorisation Process|321
4|Exclusivity|324
4|Market Access for Traditional Foods from Third Countries|325
2|4 Concluding Remarks|326
2|References|328
1|Agricultural Biotechnology: Regulation in the United States and the European Union|332
2|1 Introduction|332
2|2 Genetically Engineered Crops|335
3|2.1 Regulation in the United States|336
4|Authorisation|336
4|Labels for GE Food|339
4|Recent Developments|340
3|2.2 Regulation in the European Union|343
4|Authorisation|343
4|Member State Discretion|346
4|Labelling in the EU|348
2|3 Genetically Engineered and Cloned Animals|349
3|3.1 GE Animals|351
4|US Regulation|351
4|EU Regulation|353
3|3.2 Cloned Animals|354
4|US Approach to Cloning|354
4|Cloning in the EU|355
2|4 Regulation in the US and the EU: Some Comparisons|359
3|4.1 A Few Commonalities|359
4|Scientific Risk Assessment|359
4|Lengthy Regulatory Process|359
4|Coexistence|361
4|Labelling|361
3|4.2 Risk Management|362
4|Precautionary Principle|362
4|Socioeconomic Issues|364
3|4.3 Regulatory Barriers: Asynchronous Approvals and Low-Level Presence|366
3|4.4 Innovative Technologies|369
2|5 Conclusion|373
2|References|374
2|Literature|374
2|US Statutes, Regulations, and Regulatory Documents|378
2|Statutes and Regulations|378
2|Agency Policy and Proposals|379
2|EU Legislation and Commission Documents|379
2|Legislation (in Chronological Order)|379
2|Commission and Parliament Documents|380
1|Regulating and Managing Food Safety in the EU: A Legal-Economic Perspective|8
2|1 Introduction|8
2|2 Outline|10
3|2.1 Public-Private|10
3|2.2 Mandatory-Voluntary|11
3|2.3 Prescription-Persuasion|12
3|2.4 Rules-Principles|13
3|2.5 Ex-Ante-Ex-Post|13
3|2.6 Centralisation-Decentralisation|14
2|3 Epilogue|15
2|References|16
1|Private Food Safety Standards in the EU|17
2|1 Introduction|18
3|1.1 Characteristics of Private Food Standards|18
4|Development of Private Standards|18
4|Characteristics of Private Food Standards|20
3|1.2 Major Transnational Private Food Standards and Third Party Certification|24
2|2 Relations Between Public and Private Actors|28
3|2.1 Rule-Making|28
3|2.2 Adoption|32
3|2.3 Monitoring and Enforcement|35
3|2.4 Evaluation and Review|38
2|3 Conclusion|39
2|References|39
1|Investigating the Regulatory Structure of Voluntary Sustainability Standards: Foundations for Intervention Strategies to Incre...|44
2|1 Introduction|44
2|2 Theoretical Framework|45
2|3 Methodology|50
2|4 Results|51
3|4.1 Diversified Aim of VSSs|51
3|4.2 High NGO Involvement in Standard-Setting|52
3|4.3 Certification of Standards Often Through Private, Third-Party Certification|53
2|5 General Discussion|54
2|References|58
1|Environmental Sustainability and the Food System|61
2|1 The Concept of Sustainability|62
2|2 Issues of Environmental Sustainability of the Food System|64
2|3 Public Intervention|70
2|4 Regulatory Framework in the EU|73
3|4.1 Common Agricultural Policy|74
3|4.2 Common Fisheries Policy|75
3|4.3 Food Waste|76
3|4.4 Voluntary Measures|79
3|4.5 Private Standards|80
2|5 Consumer Perception of Environmental Sustainability and Food|81
2|6 Environmental Sustainability and Health|83
2|7 Conclusions|86
2|References|89
1|EU Health Claims: A Consumer Perspective|93
2|1 Introduction|93
2|2 A Framework for the Role of Claims and Symbols in Consumer Behaviour|95
2|3 Health Goals|96
3|3.1 Fit Between the Salient Health Goal and Products (Believed to) Satisfy it|96
3|3.2 Health Goals|97
3|3.3 Selective Attention|98
2|4 How Consumers Process Health Claims|99
3|4.1 Health Claims and Symbols in the Packaging Context|99
3|4.2 Inference Making|101
3|4.3 (Correct) Understanding of Health Claims|102
2|5 Discussion and Implications for EU Law|103
2|References|105
1|Regulatory Compliance and Company Strategies: The Case of the Nutrition and Health Claims Regulation (EC) No. 1924/2006|109
2|1 Introduction|109
2|2 A Brief Literature Review on Innovation, Regulation and the NHCR in the EU|112
3|2.1 Innovation in the EU Food Industry|112
3|2.2 Impact of Regulation on Innovation in General and for the Food Industry in Particular|114
3|2.3 The Current Status of the Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR)|115
2|3 Methods|117
2|4 The NHCR: Potential Challenges and Criticalities|117
2|5 Possible Compliance Strategies to Deal with the NHCR|121
2|6 Discussion and Conclusions|126
2|References|129
1|Foods for Specific Consumer Groups|133
2|1 Introduction|133
2|2 Protecting the Consumer Under European Food Law|135
3|2.1 Generic Safety Rules for Consumers|135
3|2.2 Generic Commercial Protection Rules for Consumers|136
3|2.3 Foods for Specific Consumer Groups in the EU|138
4|The Market of Foods for Specific Consumer Groups|138
4|Regulating Foods for Specific Consumer Groups|139
4|Innovation and Specific Food Products: Today and Tomorrow|141
2|3 Discussion|143
3|3.1 Complexities in Consumers´ Decision Making Process|144
4|Informed Choice?|144
4|Safety of Vulnerable Consumers|146
3|3.2 Complexities in the Businesses´ Decision Making Process|147
3|3.3 Case Study: The Elderly Population|149
2|4 Conclusions|151
2|References|152
1|Commanding to ``Nudge´´ via the Proportionality Principle?|155
2|1 Introduction|156
2|2 The Food Safety Goal of EU Food Law and Its Choice Architecture|157
2|3 Central Elements of the Nudging Approach|158
3|3.1 Present Biases and Structuring of Tempting Choices|160
3|3.2 Status Quo and Default Effects and Associated Nudges|160
2|4 Preference for Nudging via the Proportionality Principle?|161
2|5 Available Evidence of Effectiveness of Nudging Interventions|165
2|6 Conclusions: Applying These Insights to the Proportionality Principle|167
2|References|168
1|Obesity, Fat Taxes and Their Effects on Consumers|172
2|1 Introduction|172
2|2 Causes and Effects of Obesity: An Economic Perspective|174
3|2.1 Causes of Obesity|174
3|2.2 Effects of Obesity|176
3|2.3 Regulatory Approaches|177
2|3 Fat Taxes: Rationale and Implementations in Europe|177
3|3.1 Rationale of Fat Taxes|178
4|Is a Fat Tax an Adequate Measure to Internalize Negative Externalities?|178
4|Are Fat and Sugar Demerit Goods?|179
3|3.2 Fat Tax Implementations in the European Union|179
4|Denmark|180
4|Finland|181
4|France|181
4|Hungary|182
3|3.3 Lessons Learned from Fat Tax Implementations in Europe|183
2|4 Expected and Observed Effects of Fat Taxes on Consumers|183
3|4.1 Expected Effects|183
3|4.2 Observed Effects from Different Types of Empirical Studies|186
4|Observation Studies|186
4|Experimental Studies|189
4|Simulation Studies|191
3|4.3 Lessons Learned from Empirical Studies|192
2|5 Conclusions and Outlook|193
2|References|194
1|Substance Over Form: A Principle for European Food Information Regulation?|197
2|1 Introduction|197
2|2 Food Information Regulation and Its Principles|200
3|2.1 General Principles in the Food Information Regulation|203
4|Soft Attributes|204
4|Producers´ Rights|205
3|2.2 Formal Principles of (Food Information) Law|206
4|Coherence|207
4|Completeness|208
4|Clarity|208
2|3 Manifestations of `Fraud´|208
3|3.1 `Fraud-by-Object´|209
3|3.2 `Fraud-by Effect´|211
2|4 Substance Over Form|212
2|5 Final Remarks|215
2|References|215
1|European Food Law and the Precautionary Principle: Paradoxical Effects of the EU´s Precautionary Food Policies|218
2|1 Introduction|218
2|2 Precaution and EU Food Law|222
2|3 Antibiotic Residues in Food|223
2|4 Micro-Nutrition and Health|226
3|4.1 The Food Supplements Directive|227
3|4.2 The Nutrition and Health Claims Regulation|228
2|5 Economic Effects of Precautionary Food Policy|231
2|6 The Problems of Precautionary Food Policy Revisited|235
2|7 Conclusions|238
2|References|241
1|Enforcement of European Food Laws|246
2|1 Introduction|246
2|2 The Law and Economics of Food Law Enforcement in Europe|247
3|2.1 Sketching the Landscape|247
4|At European Level|248
4|At Member States Level|248
5|Public Law Enforcement|249
5|Private Law Enforcement|249
3|2.2 An Economic Appraisal|251
4|Private Law Enforcement|253
4|Public Law Enforcement|255
4|Interim Conclusions|258
3|2.3 Application to the European Approach|260
2|3 Conclusion|261
2|References|261
1|The Economics of Harmonization of Food Law in the EU|264
2|1 Introduction|264
2|2 Basic Economic Principles|265
3|2.1 Tiebout|265
3|2.2 Competing Legal Orders|266
3|2.3 ``Bottom up Federalism´´|267
2|3 Criteria for Harmonization of Food Law|268
3|3.1 Transboundary Externalities|268
4|General|268
4|Food|269
3|3.2 Designing Optimal Jurisdictions|270
4|General|270
4|Food|270
3|3.3 Race to the Bottom-Race to the Top|271
4|Race to the Bottom|271
5|General|271
5|Food|271
4|Race to the Top|273
5|General|273
5|Food|274
3|3.4 Internal Market|274
4|General|274
4|Food|275
3|3.5 Reducing Transaction Costs|276
3|3.6 Minimum Level of Protection|278
4|General|278
4|Food|279
3|3.7 Summary|279
2|4 Policy Consequences|280
3|4.1 Evolution of EU Food Law|280
4|From Internal Market Towards Consumer and Health Protection|281
4|The BSE-Crisis|282
4|EFSA|283
4|Incomplete Centralization|284
3|4.2 Analysis of the Hybrid System|285
2|5 Concluding Remarks|287
2|References|288
1|Pre-Market Approval and Its Impact on Food Innovation: The Novel Foods Example|292
2|1 The Concept of Novel Foods|292
3|1.1 Emerging Systems of Pre-Market Assessment of Foods and Food Ingredients|293
3|1.2 The Regulation of Novel Foods in the European Union|294
3|1.3 Practical Issues in the Application of the EU Definition of Novel Food|299
4|Product Categorisation|299
4|Borderline to Other Legal Regimes|301
4|Consumed to a Significant Degree|306
4|Novel Production Process|307
4|Additional Requirements|308
2|2 Regulatory Considerations in the Approval Process|309
3|2.1 Safety|310
3|2.2 Community Law and ``Other Legitimate Factors´´|311
2|3 Impact on Food Business Operators|314
3|3.1 The Role of Innovation for the Competitiveness of Food Manufacturers|314
3|3.2 Innovation Under the Novel Foods Regulation|316
4|Grey Areas in the Product Classification|316
5|Product Categorisation|317
5|Novel Technology in Food Production|317
5|Borderline to Other Legal Regimes|318
4|Other Requirements|320
4|Duration of the Authorisation Process|321
4|Exclusivity|324
4|Market Access for Traditional Foods from Third Countries|325
2|4 Concluding Remarks|326
2|References|328
1|Agricultural Biotechnology: Regulation in the United States and the European Union|332
2|1 Introduction|332
2|2 Genetically Engineered Crops|335
3|2.1 Regulation in the United States|336
4|Authorisation|336
4|Labels for GE Food|339
4|Recent Developments|340
3|2.2 Regulation in the European Union|343
4|Authorisation|343
4|Member State Discretion|346
4|Labelling in the EU|348
2|3 Genetically Engineered and Cloned Animals|349
3|3.1 GE Animals|351
4|US Regulation|351
4|EU Regulation|353
3|3.2 Cloned Animals|354
4|US Approach to Cloning|354
4|Cloning in the EU|355
2|4 Regulation in the US and the EU: Some Comparisons|359
3|4.1 A Few Commonalities|359
4|Scientific Risk Assessment|359
4|Lengthy Regulatory Process|359
4|Coexistence|361
4|Labelling|361
3|4.2 Risk Management|362
4|Precautionary Principle|362
4|Socioeconomic Issues|364
3|4.3 Regulatory Barriers: Asynchronous Approvals and Low-Level Presence|366
3|4.4 Innovative Technologies|369
2|5 Conclusion|373
2|References|374
2|Literature|374
2|US Statutes, Regulations, and Regulatory Documents|378
2|Statutes and Regulations|378
2|Agency Policy and Proposals|379
2|EU Legislation and Commission Documents|379
2|Legislation (in Chronological Order)|379
2|Commission and Parliament Documents|380