Biotech Food‘safety and beyond’

Jeanine A. G. van de Wiel

Health Council of the Netherlands

Committee on Safety Assessment of Novel Foodshttp://www.healthcouncil.nl/

Purpose

To learn from the past ten years of the GM-food safety debate

To facilitate and improve discussions now and in future

Introduction (1)

GREEN biotechnology is in a turbulent phase

Compare RED biotechnology Compare WHITE biotechnology

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

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

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

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

Expert Consultation

• Quality check on analytical chemistry, nutrition, molecular biology, toxicology and epidemiology investigational data

• Integration into a final opinion.

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?

Future Products

Combinations of characteristics in plants Plants containing specific bio-active

compounds (nutritionally enhanced) Animals

Beyond Food Safety

• Decline of biodiversity

• Real health claims

• Freedom of food choice

• Coexistence of biotech, conventional and organic agriculture

• Monopolization of biological resources

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