EU Food Law Handbook 2014

Table of contentsForeword 7David ByrnePreface 11Bernd van der MeulenNew, continuing and celebrating 11Objectives 11Scope 12Presentation and references 12Language 13Dedication 13Abbreviations 311. Introduction 39Bernd van der Meulen and Menno van der Velde1.1 The food sector and its law 391.2 Multi-layered food law 391.3 This book 391.4 Overview 40I. Prerequisites2. Introduction to law 45Bernd van der Meulen and Menno van der Velde2.1 Introduction to legal science 452.2 Sources of law 472.3 Legal analysis 482.3.1 Legal relation 482.3.2 ORC grid 502.3.3 If-then syntax 512.4 Branches of law 512.5 Constitutional law 522.6 Administrative law 552.6.1 The decision 552.6.2 License 572.6.3 Subsidy 572.6.4 Administrative enforcement 572.6.5 Injunction 582.6.6 General principles of good governance 582.6.7 Administrative procedure 582.6.8 Administrative review 5916 EU Food Law HandbookTable of contents2.6.9 Appeal to a judge 602.7 Criminal law 612.8 Private law 622.8.1 Draft Common Frame of Reference 622.8.2 Law of persons 632.8.3 Property law 652.8.4 Contract law 662.8.5 Non-contractual liability law (tort law) 672.9 Substantive and procedural law 682.9.1 Code of Civil Procedure 682.9.2 Execution of judgements in private law cases 692.9.3 Criminal Procedural Code 692.10 International private law 702.10.1 Conflict rules 702.10.2 Harmonisation of different national private law 722.11 International public law 732.12 European Union law 732.13 Food law 733. International food law 75Hanna Schebesta, Bernd van der Meulen and Menno van der Velde3.1 Introduction 753.2 General introduction to international public law 753.2.1 The origins of international law: the nation state 753.2.2 Sources of public international law 753.2.3 Treaties 763.2.4 Treaty making 763.2.5 The relationship between international and national law 763.2.6 Intergovernmental organisations 773.2.7 Players in the Global Arena 773.2.8 The United Nations (UN) 773.2.9 Food and Agriculture Organization (FAO) 813.2.10 World Health Organization (WHO) 813.2.11 Codex Alimentarius Commission (CAC) 823.2.12 World Food Programme (WFP) 823.2.13 World Trade Organization (WTO) 833.2.14 Supranational organisations 843.3 International food law 853.4 The Human Rights dimension of international food law 853.4.1 Human Rights in international law 853.4.2 United Nations 853.4.3 Council of Europe 883.5 The trade dimension of international food law 893.5.1 The World Trade Organization 89EU Food Law Handbook 17Table of contents3.5.2 General exceptions under the GATT 893.5.3 The Agreement on the application of sanitary and phytosanitarymeasures 903.5.4 The Agreement on Technical Barriers to Trade 933.5.5 Outlook 963.6 Codex Alimentarius 973.6.1 Procedural Manual 983.6.2 Standards 993.6.3 Codes of practice 993.6.4 Legal force 1003.6.5 European Union 1013.6.6 Codex in the General Food Law 1023.7 Businesses and international trade disputes 1043.7.1 The Trade Barriers Regulation 1043.7.2 Damages 1043.8 Concluding remark 1054. The foundations of the European Union 107Hanna Schebesta and Menno van der Velde4.1 Introduction 1074.2 The basic structure of the EU and its law 1084.3 The Lisbon Treaty reform 1124.3.1 The principle of conferral and the duty of loyal cooperation 1134.3.2 Subsidiarity 1164.3.3 Proportionality 1174.4 The powers of the EU 1184.4.1 Example of the conferral of power 1224.4.2 Additional powers 1244.4.3 Implied powers 1254.5 EU policy instruments 1254.5.1 Primary law and secondary law 1264.5.2 The regulation 1264.5.3 The directive 1284.5.4 The decision 1304.5.5 Direct effect 1324.5.6 Direct effect is not limited to Treaty articles 1345. The institutions of the European Union 139Morten Broberg and Menno van der Velde5.1 The European Council 1395.2 The Council of the European Union 1395.2.1 Voting in the Council of the European Union 1415.3 The European Commission 1435.3.1 Day-to-day administration 14318 EU Food Law HandbookTable of contents5.3.2 Guardian of the Treaties 1465.4 The European Parliament 1475.5 Council and Commission - Delegating competence to the Commission,and controlling it 1485.5.1 Introduction 1485.5.2 Delegated Acts 1495.5.3 Implementing Acts (Comitology) 1505.5.4 Characteristics of the comitology procedure 1535.5.5 The advisory procedure 1545.5.6 The examination procedure 1555.5.7 Comitology procedure applicable to the General Food Law 1575.5.8 Special procedures 1585.6 The Court of Justice of the European Union 1585.6.1 The preliminary ruling procedure 1605.6.2 Proceedings for failure to fulfil an obligation (also called theinfringement procedure) 1615.6.3 Proceedings for annulment 1625.6.4 Proceedings for failure to act 1625.6.5 The General Court of the European Union 1625.6.6 Proceedings initiated by natural or legal persons 1635.7 The European Court of Auditors 1635.8 The European Central Bank 1645.9 The European Food Safety Authority 1645.9.1 EFSA's mission 1645.9.2 The organisation of EFSA 1655.9.3 The Management Board 1655.9.4 Regulation of EFSA 1675.9.5 Integrity, independence and transparency 1695.9.6 EFSA Code of good administrative behaviour 1725.9.7 The Executive Director 1745.9.8 The Advisory Forum 1755.9.9 Scientific opinions 1755.9.10 The Scientific Panels 1765.9.11 The Scientific Committee 1785.9.12 Tasks of EFSA 1795.9.13 The organisation of the EFSA staff 1825.9.14 Legal protection 1825.10 The Standing Committee on the Food Chain and Animal Health 1825.11 The Advisory group on the food chain and animal and plant health 1835.12 Stakeholders' participation 184EU Food Law Handbook 19Table of contents6. The embedding of food law into substantive EU law 187Morten Broberg and Menno van der Velde6.1 Introduction 1876.2 The Customs Union 1876.3 Ban on all customs levies and all measures with an equivalent effect 1886.4 Ban on quantitative restrictions 1886.5 Trade wars 1906.6 The common market 1926.7 Technical barriers to trade 1936.8 From common to internal market 1946.9 Strengthening of substantive EU law 1977. Food law: development, crisis and transition 199Bernd van der Meulen7.1 History of European food law 1997.2 Creating an internal market for food in Europe 2007.3 Advancement through case law 2027.3.1 Dassonville 2037.3.2 Cassis de Dijon 2037.3.3 Mutual recognition 2057.3.4 Reinheitsgebot 2067.3.5 Brasserie du Pecheur 2077.4 Breakdown 2087.5 The White Paper: a new vision on food law 2147.5.1 Planning a European Food Safety Authority 2147.5.2 Planning new food safety legislation 2157.5.3 Planning improvement of food safety controls 2157.5.4 Planning improvement of consumer information 2177.5.5 International dimension 2177.6 Intermezzo: documents 2177.7 Follow up 2197.8 Future 220II. Systematic analysis of food law8. Systematic analysis of food law 223Bernd van der Meulen8.1 Introduction 2238.2 A structure of food law as framework of analysis 2248.3 Stakeholders in EU Food Law 2268.4 Principles and concepts 2268.5 Obligations of businesses 2268.5.1 Product requirements 2278.5.2 Process requirements 22720 EU Food Law HandbookTable of contents8.5.3 Communication requirements 2278.6 Powers of public authorities 2278.7 Choice 2279. The General Food Law: general provisions of food law 229Bernd van der Meulen and Anna Szajkowska9.1 The General Food Law 2299.2 Aim and scope 2299.3 Definitions 2309.3.1 Food 2319.3.2 Food law 2349.3.3 Food business 2359.3.4 Placing on the market 2379.3.5 Competent authority 2379.3.6 Food safety 2389.4 General principles 2399.5 Focussed objectives 2429.6 Risk analysis, risk management and risk communication 2449.6.1 Concepts 2449.6.2 Scope 2469.7 Precautionary principle 2469.7.1 Background 2469.7.2 Conditions 2489.7.3 Precaution and risk analysis 2489.7.4 Provisional and proportional measures 2489.8 Food law and science 2499.9 Other consumer interests 2509.10 Transparency 2519.10.1 Public consultation 2519.10.2 Public information 2519.11 International trade 2519.11.1 Import 2519.11.2 Export 2519.11.3 International standards 2529.12 Food safety: a duty of care 2529.12.1 Responsibility 2529.12.2 Ban on unsafe food 2539.12.3 Health effects 2559.12.4 Unfit for consumption 2559.12.5 Conclusions from sampling 2569.12.6 Foods complying with food safety requirements 2569.12.7 Foods not complying with food safety requirements 2569.12.8 Unsafety and risk assessment 2579.13 Implementation of the General Food Law 259EU Food Law Handbook 21Table of contents10. Authorisation requirements 261Dominique Sinopoli, Jaap Kluifhooft and Bernd van der Meulen10.1 Introduction 26110.1.1 Legislation addressing the product 26110.1.2 Pre-market approval 26210.1.3 Positive lists 26310.2 Food Improvement Agents Package 26310.2.1 Food additives 26410.2.2 Processing aids 26510.2.3 Authorisation of additives 26610.2.4 Specifications: criteria of purity and identity 26910.2.5 Enzymes 26910.2.6 Flavourings 26910.3 Food supplements 27010.3.1 General 27010.3.2 Authorisation 27110.3.3 Monitoring 27110.4 Novel foods 27110.4.1 Concept 27110.4.2 Authorisation 27410.5 Genetically modified foods 27510.5.1 Introduction 27510.5.2 The GM package 27610.5.3 Novel Foods and GMOs 27710.5.4 Environmental approval 27710.5.5 Food approval 27810.5.6 Application procedure 27910.5.7 Authorisation 28310.5.8 Identification 28410.5.9 Liability 28410.5.10 Modification and renewal 28510.5.11 Suspension and revocation 28510.6 Functional foods 28510.7 Other approval schemes 28610.8 Pre-market approval schemes 28710.8.1 Precautionary approach 28710.8.2 Criteria 28810.8.3 Competences 28910.8.4 Authorisations 28910.8.5 Road map 29110.8.6 Patentability 29110.9 Developments 29210.9.1 Novel Foods 29210.9.2 Cultivation of GMOs 29310.9.3 Implementation 29422 EU Food Law HandbookTable of contents11. Contaminants and restricted substances 295Ans Punt, Dasep Wahidin and Bernd van der Meulen11.1 Introduction 29511.2 Legislation 29611.3 Setting legal limits 29711.4 Contaminants within Framework Regulation 315/93 29811.5 Acrylamide 29811.6 Pesticide residues 29911.6.1 Pre-market approval of pesticides 30011.6.2 Pesticide MRLs 30011.6.3 Default MRL 30111.7 Veterinary drugs 30211.7.1 Residues of veterinary drugs 30211.7.2 Hormones 30311.8 Food contact materials 30311.9 Radioactive contamination 30411.9.1 General limits to radioactive contamination in foods in emergencysituations 30411.9.2 Special limits for imports from Japan after the Fukushima accident 30611.9.3 Limits in case long-term exposure persists 30711.10 Overview 30712. Biological hazards 311Rozita Spirovska Vaskoska12.1 Introduction 31112.2 Microbiological criteria 31112.2.1 Definition and types of microbiological criteria 31212.2.2 Setting up microbiological criteria 31512.2.3 Application of microbiological criteria 32012.3 Other microbiological limits 32412.4 Control of zoonoses 32412.5 Specific hazards 32512.6 TSE risk material 32612.7 Animal by-products 32713. Process: hygiene, traceability and recall 329Rozita Spirovska Vaskoska, Bernd van der Meulen and Menno van der Velde13.1 Introduction 32913.2 Prevention 32913.2.1 Food hygiene 32913.2.2 Overview 33013.2.3 EU food hygiene legislation 33013.2.4 Instruments of food hygiene law 33713.2.5 Direct legislation 338EU Food Law Handbook 23Table of contents13.2.6 Registration and approval 34113.2.7 Prerequisites 34313.2.8 HACCP 34813.2.9 Guides to Good Hygiene Practice 35013.2.10 Primary production 35513.2.11 Private standards 35613.3 Preparedness 35613.3.1 HACCP 35613.3.2 Traceability 35713.3.3 General Food Law 35813.3.4 Traceability of food-producing animals 36013.3.5 GM traceability 36313.4 Response 36413.4.1 Withdrawal and recall 36413.4.2 Responsible food business operator 36513.4.3 Non-compliance 36613.4.4 Measures 36613.5 Food safety law for businesses 36714. Food labelling and beyond 369Harry Bremmers and Bernd van der Meulen14.1 Introduction 36914.2 Marketing 37014.3 Food Information 37014.4 Responsibilities 37314.5 Principles and generic requirements 37414.6 Mandatory particulars 37614.6.1 Name 37714.6.2 Ingredients 37914.6.3 Net quantity 38316.4.4 Durability 38414.6.5 Origin information 38414.6.6 Conditions and instructions 38614.6.7 Nutrition Information 38614.7 (Semi-)vertical food information requirements 38714.7.1 Products derived from primary produce 38814.7.2 Foods derived using specific technologies 38914.7.3 Foods with specific functions 39014.8 Regulated voluntary food information 39014.8.1 Organic production 39114.8.2 Voluntary identification information: PDO, PGI and TSG 39214.8.3 Nutrition and health claims 39614.9 International context of food information 40024 EU Food Law HandbookTable of contents15. Public powers: official controls, enforcement and incidentmanagement 403Frank Andriessen, Anna Szajkowska and Bernd van der Meulen15.1 Introduction 40315.2 Official controls 40415.2.1 General controls 40415.2.2 Obligations of food business operators 40515.2.3 International trade 40615.2.4 Intra-EU trade 40615.2.5 Intra-EU co-operation 40615.2.6 Second-line inspections 40715.2.7 Controls in third countries 40715.3 Measures in case of non-compliance 40815.3.1 Measures to remedy non-compliance 40815.3.2 Legal protection 40915.3.3 Measures to punish non-compliance 40915.3.4 Public communication 40915.3.5 Measures in case of lax enforcement 41015.3.6 Review of the official controls Regulation 41015.4 Incident management 41115.4.1 Rapid alert system 41215.4.2 Transmission of information 41215.4.3 Notification categories 41315.4.4 Public information and confidentiality rules 41315.4.5 Collateral damage 41315.4.6 INFOSAN 41515.5 Emergencies 41615.5.1 Role of food business operators 41615.5.2 Role of national authorities 41615.5.3 Role of the European Commission 41715.5.4 Powers of the European Commission 41715.5.5 Crisis management 42015.5.6 General plan for crisis management 42015.5.7 Crisis unit 42016. Consumer 421Bernd van der Meulen16.1 For you, about you, over you, without you 42116.2 The consumer in European case law 42116.3 Responsibility? 42316.4 Collective rights 42316.5 Complaints 42316.6 Individual consumers' rights? 42416.7 Product liability law 424EU Food Law Handbook 25Table of contents16.7.1 Strict liability 42416.7.2 Producer 42516.7.3 Damage 42516.7.4 Conditions 42716.7.5 Defences 42816.8 Concluding remarks 428III. Selected topics17. Special foods 431Irene Scholten-Verheijen17.1 Introduction 43117.2 PARNUTS legislation 43117.3 FSG Regulation 43217.4 Reasons for a new Regulation 43417.4.1 Free movement of food within the EU 43417.4.2 Evolution 43517.4.3 Limitation of categories 43517.4.4 Reducing obesity and improving diet 43617.5 The FSG Regulation in detail 43717.5.1 General provisions 43717.5.2 Compositional and information requirements 43817.5.3 Union list 44017.5.4 Procedural provisions 44117.5.5 Final provisions; transitional measures 44117.6 Future developments 44218. Importing food into the EU 443Cecilia Kuhn and Francesco Montanari18.1 Introduction 44318.1.1 Food regulatory compliance in the European Union 44318.1.2 Scope and purpose of this chapter 44418.1.3 Chapter structure 44518.2 General import requirements 44618.2.1 GFL and imports: general principles 44618.2.2 Two sets of requirements 44718.2.3 General Food Requirements 44718.3 Specific import requirements: definitions and legal basis 45018.3.1 Import requirements 45018.3.2 Risk identification 45118.3.3 Legal basis for import requirements 45218.3.4 Emergency measures 45218.3.5 Other legal basis 45318.4 Specific import requirements according to food category 45426 EU Food Law HandbookTable of contents18.4.1 Food and feed of animal origin 45418.4.2 Food and feed of non-animal origin 45718.4.3 Composite products 45918.5 Official controls 46018.5.1 Types, frequency, place, costs 46018.5.2 Procedural guarantees 46318.5.3 Risks and consequences of non-compliance 46318.5.4 Sanctions 46418.5.5 Release for free circulation and role of customs 46418.6 Emergency measures 46518.6.1 Import requirements applicable to all non-EU countries 46518.6.2 Import requirements applicable to a group of non-EU countries 46618.6.3 Import requirements applicable to one specific non-EU country 46718.7 Future developments 46918.8 Overview 47019. Food contact materials 471Karola Krell Zbinden19.1 Introduction 47119.2 Legislation concerning food contact materials 47119.3 EU legislation 47219.3.1 Framework Regulation 1935/2004 47219.3.2 GMP Regulation 2023/2006 47619.3.3 Plastics - Regulation 10/2011 47619.3.4 Active and intelligent materials 47819.3.5 Ceramics 47919.3.6 Regenerated cellulose films 47919.3.7 Recycled plastics 47919.3.8 Specific substances 48019.4 National legislation 48019.5 Further international private standards concerning FCMs 48119.6 Study case: 'mineral oils' from cartons 48119.7 Control of FCMs 48219.8 The challenge of FCMs: how to tackle safety without laws 48320. Nutrition policy in the European Union 485Martin Holle20.1 Introduction 48520.2 The establishment of public health and consumer protection asobjectives in primary and secondary EU law 48520.3 The birth of European Nutrition Policy 48720.3.1 First national initiatives 48820.3.2 From national health plans to a multi-sectoral and multidisciplinaryapproach 489EU Food Law Handbook 27Table of contents20.4 Early childhood: the 1990s 49020.4.1 1990: The first European Action Programme on Nutrition andHealth 49020.4.2 1992: The World Declaration and Action Plan on Nutrition 49020.4.3 1993: The public health mandate of the Maastricht Treaty 49120.4.4 1994: The Council of Europe Recommendation 49320.5 The school years: 2000-2003 49420.5.1 2000: The First WHO Action Plan for Food and Nutrition Policyin Europe 49420.5.2 The EU Health Framework for the New Millennium 49620.5.3 2002: The Programme of Community Action in the Field of PublicHealth 49620.6 Into adulthood: 2003 and beyond 49720.6.1 2002: The European Commission's Status Report 49720.6.2 The 2003-2008 Public Health Action Programme 50020.6.3 2005: The Commission's Green Paper on promoting healthy dietsand physical activity 50120.6.4 Carrot and stick: legislative proposals vs. European Platform onDiet, Physical Activity and Health 50220.6.5 2006: The WHO European Charter on Counteracting Obesity andthe Second Action Plan 50420.6.6 The Commission's White Paper on nutrition, overweight andobesity-related health issues 50620.6.7 The stick is out: The Regulations on Nutrition and Health claimsand on Food Information 50720.6.8 Product reformulation and self-regulatory approaches inaudiovisual media - the silence before the storm? 50920.6.9 2010: The year of truth for the effectiveness of the EU nutritionpolicy measures 51120.6.10 The implementation report on the Commission's White Paper 51220.6.11 The progress report on the European Platform for Action onDiet, Physical Activity and Health 51320.6.12 The WHO Global Action Plan 2008-2013 51520.6.13 Nutrition Policy in Europe - the interim balance and outlook 51620.7 Conclusions 52021. EU Feed Law 523Dionne Chan21.1 Introduction 52321.2 Development of EU Feed law 52421.3 General concepts and principles 52521.3.1 Concepts 52521.3.2 Objectives 52721.3.3 Principles 52728 EU Food Law HandbookTable of contents21.4 Product-focused provisions 52821.4.1 Market access requirements 52821.4.2 Purity requirements 52921.5 Process-focused provisions 52921.5.1 Prevention 53021.5.2 Preparedness 53021.5.3 Response 53021.6 Presentation 53121.6.1 Labelling 53121.6.2 Marketing of feed 53121.7 Enforcement 53321.8 Conclusion 53322. Intellectual property rights in the agro-food chain 535Bram De Jonge and Bernard Maister22.1 Introduction 53522.2 What are intellectual property rights, and what are they good for? 53622.3 Historic overview of the key international treaties on IP 53822.3.1 The Paris Convention for the Protection of Industrial Property 53822.3.2 The Berne Convention for the Protection of Literary and ArtisticWorks 53922.3.3 The World Intellectual Property Organization (WIPO) 54022.3.4 WTO and TRIPs 54122.4 Administration and enforcement of IPRs 54322.5 Patent protection in Europe 54422.5.1 European Patent Convention and the European Patent Office 54522.5.2 Patent Cooperation Treaty 54522.5.3 The European Unified Patent System 54622.5.4 Biotechnology Directive 54622.6 IPRs in the food chain 54822.6.1 Patents 54922.6.2 Trade secrets 55322.6.3 Plant breeders' rights 55422.6.4 Trademarks 55722.6.5 Industrial designs 55922.6.6 Geographical Indications 56022.7 Concluding remark 56123. Private food law 563Rozita Spirovska Vaskoska and Bernd van der Meulen23.1 Introduction 56323.1.1 Overview 56323.1.2 Voluntary rules 56323.2 The (hi)story of private standards 565EU Food Law Handbook 29Table of contents23.3 Chain orchestration 56623.3.1 Contracts 56623.3.2 Vertical integration 56623.4 Owning a standard 56723.5 Enforcement 56723.6 Adjudication 56723.7 Audits 56823.8 Certification mark 56923.9 Accreditation 57023.10 Beyond accreditation 57023.11 Standard setting 57123.12 Structure of private food law 57223.13 Interconnected private schemes 57323.14 Public - private interconnections 57323.15 Motives 57623.16 Examples 57723.17 Underlying concepts 58023.17.1 GAP/GMP 58023.17.2 HACCP 58123.18 EurepGAP/GlobalGAP 58123.19 BRC 58523.20 IFS 58623.21 SQF 58823.22 FS22000 59023.23 GFSI 59123.24 Public law on private food law 59423.25 WTO 59523.25.1 TBT 59523.25.2 SPS 59523.26 Conclusions 59724. Conclusions 599Bernd van der MeulenAppendix A. Finding sources of EU law: legislation and case-lawdatabases 601Sofie van der MeulenA.1 Introduction 601A.2 EUR-Lex, CURIA and the Legislative Observatory 601A.3 EUR-Lex 601A.3.1 Finding documents: search methods 602A.3.2 Consulting search results 606A.3.3 Document structure: referencing 606A.4 CURIA 60830 EU Food Law HandbookTable of contentsA.4.1 Finding documents: quick search 609A.4.2 Finding documents: advanced search 610A.4.3 Consulting search results 611A.5 Legislative Observatory 611A.5.1 Documentation 612A.5.2 Finding documents: homepage 612A.5.3 Finding documents: search tool 613A.5.4 Consulting search results 615Appendix B. Attribution of powers for the General Food Law,Regulation 178/2002 617References 621EU law 621Legislation and soft law 621EU Case law 640Soft law, policy documents, reports and general information 642Other sources of law 648International documents 648International case law 652Private standards 652EU Member States' and third countries' legislation 652EU Member States' and third countries' case law 653Literature 653Press 660Websites 661About the authors 663Index 667