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Evaluation of the EU Legislative Framework in the Field of GM Food and Feed Framework Contract for Evaluation and Evaluation Related Services - Lot 3: Food Chain

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Evaluation of the EU Legislative Framework in the Field of GM Food and Feed Framework Contract for Evaluation and Evaluation Related Services - Lot 3: Food Chain I European Commission Directorate General for Health and Consumers Evaluation of the EU legislative framework in the field of GM food and feed Framework Contract for evaluation and evaluation related services - Lot 3: Food Chain Appendices to Final Report Submitted by: Food Chain Evaluation Consortium (FCEC) Civic Consulting - Agra CEAS Consulting - Van Dijk Management Consultants - Arcadia International Project Leader: Agra CEAS Consulting European Commission DG SANCO Rue de la Loi 200 1049 Brussels 12 July 2010 Contact for this assignment: Dr B. Dylan Bradley Imperial College London Wye Campus, Wye, Kent, UK Phone: + 44 1233 812 181 [email protected] www.ceasc.com Evaluation of the EU legislative framework in the field of GM food and feed Appendices to Final Report Prepared by the Food Chain Evaluation Consortium (FCEC) Civic Consulting – Agra CEAS Consulting – Van Dijk Management Consultants – Arcadia International Project Leader: Agra CEAS Consulting Food Chain Evaluation Consortium c/o Civic Consulting Potsdamer Strasse 150 D-10783 Berlin-Germany Telephone: +49-30-2196-2297 Fax: +49-30-2196-2298 E-mail: [email protected] Expert Team Agra CEAS Consulting: Dr Dylan Bradley Conrad Caspari John Nganga Mariana Ricci Lucia Russo Arcadia International: Dr Rodolphe de Borchgrave Daniel Traon Civic Consulting: Philipp von Gall fcec Food Chain Evaluation Consortium Civic Consulting – Agra CEAS Consulting Van Dijk Management Consultants – Arcadia International EVALUATION OF GM FOOD AND FEED LEGISLATION DG SANCO Evaluation Framework Contract Lot 3 (Food Chain) This evaluation was commissioned by the European Commission, in the context of the framework contract signed between the European Commission and the Food Chain Evaluation Consortium. This evaluation is carried out by a team led by Agra CEAS Consulting. The opinions expressed in this document represent the authors‟ points of view which are not necessarily shared by the European Commission. Food Chain Evaluation Consortium iii EVALUATION OF GM FOOD AND FEED LEGISLATION DG SANCO Evaluation Framework Contract Lot 3 (Food Chain) Contents 1. OPTIONS FOR THE FUTURE AND THEIR LIKELY IMPACTS ............................................................................... 1 1.1. RISK ASSESSMENT AND THE REGULATORY PROCEDURE .............................................................................................. 2 1.1.1. Risk assessment .................................................................................................................................... 2 1.1.2. Risk management ................................................................................................................................. 4 1.1.3. Consideration of explicit and systematic inclusion of socio-economic criteria in the authorisation process ............................................................................................................................................................ 6 1.1.4. Public comments .................................................................................................................................. 8 1.1.5. Risk assessment data generation ....................................................................................................... 10 1.1.6. Stacked events .................................................................................................................................... 12 1.1.7. Summary ............................................................................................................................................ 16 1.2. LABELLING ..................................................................................................................................................... 16 1.2.1. Positive labelling (explicit indication that products contain or consist of GMOs) .............................. 16 1.2.2. Negative labelling (indication that products do not contain, or are not produced using, GMOs, i.e. “GM-free”) .................................................................................................................................................... 21 1.2.3. Threshold above which products containing GM material (food and feed) must be labelled ............ 23 1.2.4. Summary ............................................................................................................................................ 25 1.3. THRESHOLD FOR ADVENTITIOUS PRESENCE OF UNAUTHORISED GM MATERIAL ............................................................ 26 1.3.1. Summary ............................................................................................................................................ 29 2. SURVEY RESULTS ........................................................................................................................................ 30 2.1. INTRODUCTION ............................................................................................................................................... 30 2.2. BACKGROUND TO STAKEHOLDER SAMPLE ............................................................................................................. 31 2.3. OVERALL OBJECTIVES OF THE LEGISLATION AND EXPECTED DEVELOPMENTS IN THE SECTOR ............................................. 32 2.3.1. The food needs of EU society .............................................................................................................. 32 2.3.2. Agreement with and implementation of the stated aims of the GM legislation ................................ 35 2.4. THE RISK ASSESSMENT AND REGULATORY APPROVAL PROCESS .................................................................................. 40 2.4.1. The current system compared to the pre-2003 system ...................................................................... 40 2.4.2. Tools and guidelines available for carrying out risk assessment ........................................................ 40 2.4.3. Approach to stacked events ............................................................................................................... 41 2.4.4. Overall transparency of current system ............................................................................................. 41 2.4.5. Assessment of specific aspects of the authorisation process ............................................................. 42 2.4.6. Member State voting criteria ............................................................................................................. 48 2.4.7. Impact of GM legislation on the evolution of the GM food and GM feed sectors .............................. 48 2.4.8. Strengths and weaknesses of the EU authorisation system ............................................................... 49 2.4.9. Use of and satisfaction with public comments in the authorisation process ..................................... 51 2.4.10. Appropriateness of Article 34 to deal with emergency measures .................................................... 52 2.4.11. Interplay with legislation in other areas ........................................................................................... 53 2.4.12. The consequences of asynchronous authorisation ........................................................................... 54 2.5. THE COMPULSORY LABELLING OF GM FOOD AND FEED ........................................................................................... 56 2.5.1. Perceptions of the current labelling regime ....................................................................................... 56 2.5.2. Consumer campaigns related to GM food and feed labelling ............................................................ 58 2.5.3. Costs of controlling current labelling legislation ................................................................................ 59 2.5.4. Costs of implementing current labelling legislation for food.............................................................. 59 2.5.5. Costs of implementing current labelling legislation for feed .............................................................. 62 2.5.6. Presence of GM labelled food on national markets ........................................................................... 64 2.5.7. Presence of GM labelled feed on national markets ............................................................................ 65 2.5.8. Factors driving market share of GM labelled food ............................................................................. 67 2.5.9. Factors restricting market share of GM labelled food ........................................................................ 69 2.5.10. Factors driving market share of GM labelled feed ........................................................................... 70 2.5.11. Factors restricting market share of GM labelled feed ...................................................................... 71 Food Chain Evaluation Consortium iv EVALUATION OF GM FOOD AND FEED LEGISLATION DG SANCO Evaluation Framework Contract Lot 3 (Food Chain) 2.5.12. Potential benefits and costs of extending GM labelling to encompass livestock products .............. 73 2.5.13. Potential impact on demand for livestock products if included within positive labelling scope....... 74 2.5.14. Potential impact on prices for livestock products if included within positive labelling scope .......... 75 2.5.15. The current use of “GM-free” labelling schemes .............................................................................
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