the General Food Law Regulation

243 Pages·2017·2.58 MB·English

Study on the
evaluation of
Regulation (EC) No
178/2002 (“the
General Food Law
Regulation”)

Final Report

Dr Maria Christodoulou, Agra CEAS Consulting
October, 2015
Evaluation of the General Food Law (GFL)

EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Directorate [Directorate letter] — [Directorate name -see organigramme]
Unit [Directorate letter.Unit number, e.g. A.1] — [Unit name -see organigramme]
Contact: [First name Last name]
E-mail: […]@ec.europa.eu (functional e-mail if existing, or)
[First name.Last name]@ec.europa.eu

European Commission
B-1049 Brussels

Food Chain Evaluation Consortium 1
Evaluation of the General Food Law (GFL)

Study on the evaluation of
Regulation (EC) No 178/2002
(“the General Food Law
Regulation”)
Final Report

Food Chain Evaluation Consortium 2
Evaluation of the General Food Law (GFL)

Title Study on the evaluation of Regulation (EC) No 178/2002 (“the
General Food Law Regulation”)
Conducted for European Commission, Directorate-General for Health and Food
Safety
By Food Chain Evaluation Consortium (Civic Consulting - Agra CEAS
Consulting - Arcadia International - Van Dijk Management
Consultants)
Project leader Agra CEAS Consulting
Author Dr. Maria Christodoulou ([email protected])
Reviewed by: Dr. Dylan Bradley
Date 15.10.2015

Food Chain Evaluation Consortium 3
Evaluation of the General Food Law (GFL)

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Table of contents

Acknowledgements ............................................................................................... vii
Abstract ........................................................................................................... viii
Key Messages .................................................................................................... ix
EXECUTIVE SUMMARY ......................................................................................... I
1.1. Introduction ................................................................................................. I
1.2. Methodology ................................................................................................ I
1.3. Main findings: implementation and impacts of the core GFL provisions ................ I
1.4. Overall assessment of the GFL, conclusions and recommendations .................... V

I. DESCRIPTION OF THE STUDY ........................................................................... 1
I.1 Economic and legal context ........................................................................ 1
I.1.1 Food law, public health and the economic dimension of the EU food and feed
supply chain ................................................................................................... 1
I.1.2 The General Food Law (GFL): aim, objectives and scope ............................. 4
I.1.3 The situation prior to the GFL (baseline) .................................................. 10
I.2 Aim and objectives of the evaluation .......................................................... 11
II. METHODOLOGY ............................................................................................ 13
II.1 Scope ..................................................................................................... 13
II.2 Data collection strategy ............................................................................ 14
II.2.1 Overview .......................................................................................... 14
II.2.2 Case studies ...................................................................................... 15
II.3 Fine-tuning of the methodology and tools ................................................... 18
II.3.1 Challenges, limitations and mitigating measures .................................... 18
II.3.2 Challenges and caveats of using certain quantitative indicators................ 21
II.3.3 Judgement criteria and indicators ........................................................ 25
II.4 Analysis and synthesis of results, including quality checks and data validation . 26
III. MAIN FINDINGS: ANALYSIS OF IMPLEMENTATION STATE OF PLAY AND IMPACTS
(ANSWERS TO EQs) ............................................................................................. 28
III.1 Interpretation and enforcement of the GFL (EQ24) ....................................... 28
III.2 GFL definitions and scope (EQ19) ............................................................... 32
III.3 Core requirements for feed/food operators .................................................. 37
III.3.1 Traceability (EQ14/EQ15) ................................................................... 37
III.3.1.1 Implementation ........................................................................... 38
III.3.1.2 Impact and added value ............................................................... 44
III.3.2 Allocation of responsibilities (EQ12/EQ13) ............................................. 50
III.3.2.1 Food chain: primary responsibility (EQ 12)...................................... 50
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III.3.2.2 Public authorities: penalties and measures applied to infringements
(EQ13) 64
III.3.3 Determining food safety, withdrawals and recalls of unsafe food
(EQ8/EQ9/EQ10/EQ11) ................................................................................... 66
III.3.3.1 Overall assessment of food safety and withdrawals/recalls (EQ8/EQ9) 68
III.3.3.2 Assessment of specific provisions (EQ10/EQ11) ............................... 75
III.4 Risk analysis ........................................................................................... 78
III.4.1 Application of risk assessment and risk management (EQ20) .................. 79
III.4.1.1 Application of risk analysis at MS/EU level....................................... 81
III.4.1.2 Separation of risk management and risk assessment process in practice
92
III.4.1.3 Impact of measures taken on the basis of risk analysis ................... 100
III.4.2 Application of the precautionary principle (PP) (EQ21) .......................... 108
III.4.2.1 Incidence and approach of use .................................................... 109
III.4.2.2 Impact of measures taken on the basis of the PP ........................... 112
III.5 Transparency ........................................................................................ 115
III.5.1 Public consultation (EQ22) ................................................................ 117
III.5.2 Public information (EQ23) ................................................................. 120
III.6 Trade and international aspects ............................................................... 124
III.6.1 Imports and exports (EQ16/EQ17) ..................................................... 125
III.6.2 International standards (EQ18) ......................................................... 131
III.7 Coherence and complementarity .............................................................. 132
III.7.1 Internal coherence (EQ32) ................................................................ 133
III.7.2 External coherence (EQ33) ............................................................... 134
III.7.3 Complementarity (EQ34) .................................................................. 135
III.8 Achievement of objectives ....................................................................... 137
III.8.1 Protection of consumers’ health and interests (EQ3) ............................. 137
III.8.1.1 Overall assessment .................................................................... 137
III.8.1.2 Prevention of fraud and misleading practices (EQ6) ........................ 140
III.8.2 Internal Market (EQ5) ...................................................................... 144
III.8.3 Other objectives, interests and needs (EQ4/EQ7) ................................. 147
III.9 Cost and burden of core GFL requirements ................................................ 153
III.9.1 Specific concerns on costs and burden (EQ25/EQ29) ............................ 153
III.9.2 Extent to which certain aspects of the GFL and its implementation act as
mitigating factors ......................................................................................... 159
III.9.2.1 Level of prescriptiveness (EQ26) .................................................. 159
III.9.2.2 Combination with other tools (EQ27) ............................................ 160
III.9.2.3 Adaptability to national markets and cultures (EQ28) ..................... 162
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III.9.3 Potential for simplification including potential for cost and burden reduction
(EQ30/EQ31) ............................................................................................... 163
IV. OVERALL ASSESSMENT (ANSWERS TO EVALUATION CRITERIA) ....................... 168
IV.1 Relevance ............................................................................................. 168
IV.2 Effectiveness ......................................................................................... 171
IV.3 Efficiency .............................................................................................. 179
IV.4 Coherence ............................................................................................. 184
IV.5 European added value ............................................................................ 186
V. CONCLUSIONS ........................................................................................... 189
VI. RECOMMENDATIONS ................................................................................... 195

Annexes ........................................................................................................... 198
Annex 1: ToR ................................................................................................... 199
Annex 2: Judgement criteria, indicators and methodological tools ........................... 200
Annex 3: Analysis of consolidated survey results (MS CAs and stakeholders) ............ 201
Annex 4: Analysis of SME Panel results ................................................................ 202
Annex 5: Data collection tools ............................................................................. 203
Annex 6: Background documents ........................................................................ 204
Annex 7: Stakeholder mapping ........................................................................... 213
Annex 8: Reviewed literature .............................................................................. 216

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List of Tables

Table 1: Legislative framework and state of play: the GFL and other key secondary
legislation (a) ....................................................................................................... 6
Table 2: Case study themes .................................................................................. 17
Table 3: Problems identified with definitions (GFL; other secondary legislation) (a) ...... 36
Table 4: Cases of EU measures not adopted on the basis of risk analysis, according to
industry stakeholders (a) ...................................................................................... 83
Table 5: Application of risk analysis in MS, prior to the GFL (examples) (a) ................. 86
Table 6: Adjustments in MS to apply risk analysis as laid down in Article 6 (examples) (a)
.......................................................................................................................... 89
Table 7: Cases where the basis of national MS measures is questioned (a) .................. 92
Table 8: Consideration of other legitimate factors in various cases of EU measures taken
on the basis of other secondary legislation (examples).............................................. 98
Table 9: Use of the precautionary principle (GFL Article 7) in EU food law (a) ............ 111
Table 10: National measures in place, consistent with the provisions of Article 8 ........ 141
Table 11: Key findings of the study on the effectiveness of the GFL provisions ........... 175
Table 12: Areas of food/feed law where problems were identified due to incomplete
harmonisation (a) .............................................................................................. 193

List of Figures

Figure 1: Structure of the General Food Law ............................................................ 13
Figure 2: Data collection strategy (GFL evaluation)................................................... 15
Figure 3: Layers of implementation of the General Food Law (GFL) ............................ 29

List of Boxes

Box 1: Implementation of primary responsibility (Art.17.1) in the food sector .............. 55
Box 2: Case where the balance of ‘other legitimate factors’ in risk management is not
clear – GMOs (source: industry) ............................................................................. 96
Box 3: Cases where ‘other legitimate factors’ were taken into account (source: food
industry) ........................................................................................................... 100
Box 4: Costs of preparing an application dossier (authorisation of feed additives) ...... 107

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Acronyms

ABP Animal by product
AGRI Directorate General for Agriculture and Rural Development
AT Austria
B2B Business to business
B2C Business to consumer
BE Belgium
CA/s Competent Authority/ies
CAP Common Agricultural Policy
COM European Commission
CZ Czech Republic
DE Germany
DG Directorate General of the European Commission
EC European Community
EE Estonia
EEC European Economic Community
EEN Europe Enterprise Network
EFSA European Food Safety Authority
ES Spain
EU European Union
EURL European Union Reference Laboratory
EQ Evaluation Question
FBO/s Food Business Operator/s
FCEC Food Chain Evaluation Consortium
FCM Food Contact Materials
FI Finland
FIC Food Information to Consumers (Regulation (EU) No 1169/2011)
FR France
FSG Food for Specific Groups
FTA Free Trade Agreement
FVO Food and Veterinary Office (European Commission)
GAPs Good Agricultural and Animal Husbandry Practices
GFL General Food Law (Regulation (EC) No 178/2002)
GFSI Global Food Safety Initiative
GM Genetically Modified
GMPs Good Manufacturing Practices
GROW DG for Internal Market, Industry, Entrepreneurship and SMEs
GTPs Good Trading Practices
HACCP Hazard Analysis and Critical Control Point
HU Hungary
IFS International Featured Standards
IT Italy
MANCP Multi-Annual National Control Plan
ML/s Maximum Limits
MOE Measures of Effectiveness
MOS Measures of Suitability
MRL/s Maximum Residue Levels
MS Member State/s
NGO Non Governmental Organism
NL Netherlands
NMS New Member State
NRL National Reference Laboratory
RASFF Rapid Alert System for Food and Feed
REFIT Regulatory Fitness and Performance Programme
PAFF Standing Committee on Plants, Animals, Food and Feed (former SCOFCAH)
PCB Polychlorinated Biphenyls
PP Precautionary Principle
SANTE European Commission’s Directorate General for Health and Consumers
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