1. Biotech Food ‘safety and beyond’ Jeanine A. G. van de Wiel Health Council of the Netherlands Committee on Safety Assessment of Novel Foods http://www.healthcouncil.nl/

2. Purpose To learn from the past ten years of the GM-food safety debate To facilitate and improve discussions now and in future

3. Introduction (1)  GREEN biotechnology is in a turbulent phase  Compare RED biotechnology  Compare WHITE biotechnology

4. Introduction (2)  Food safety became an issue because of a number of ‘incidents’  Background: How to feed oneself in a technological culture?  Controversies about facts and values  Governments learn by doing and through a process of dialogue and consultation

5. Safety and Precaution (1)  Regulation (EC) nr 258/97 concerning novel foods and food ingredients  Recommendation 97/618/EC about the information required to support an ‘application for authorization’  European general food law (EC)178/2002

6. Safety and Precaution (2)  Regulation (EC) 1830/2003 concerning the traceability and labeling of genetically modified organisms, foods and feeds (amending 2001/18/EC)  Regulation (EC) 1829/2003 on genetically modified food and feed

7. Transparency in Decision-Making Public version of the dossier available Public version of the expert advisory reports on website Declaration of interests of expert committee members Stakeholder consultation

8. Expert Consultation Quality check on analytical chemistry, nutrition, molecular biology, toxicology and epidemiology investigational data Integration into a final opinion.

9. Expert Consultation Items  Full assessment or notification  Substantial equivalence  Extent of bio-molecular characterization  Design field studies for nutritional characterization  Relevant toxicological endpoints  Design of experimental animal study  Pre- or post-market human studies?

10. Future Products  Combinations of characteristics in plants  Plants containing specific bio-active compounds (nutritionally enhanced)  Animals

11. Beyond Food Safety Decline of biodiversity Real health claims Freedom of food choice Coexistence of biotech, conventional and organic agriculture Monopolization of biological resources

12. Recommendations  Consultation processes have to be very transparent  Expert judgement has to be of high quality and depth  Not only regulate risk assessment but also structure and facilitate risk management  Use local (national) expertise  Realize a broad agricultural biotechnology assessment based on ethical principles