Health & Consumer Protection Directorate General

1. Health & Consumer ProtectionDirectorate General GMOs: scientific disagreement or differing societal perceptions? Marco Valletta, Ph. D. – DG SANCO E1 OECD 2-3 November 2009

2. Consumers’ perception and GMOs in the EU A recent study from the University of Wageningen – by Professor Lynn J. Frewer

3. Consumers Experts Consumer Awareness Consumers not willing to seek information Poor quality of information Adequate Risk management and happy consumers Risk management efforts Opaque / lack of trust Risk management priorities More acceptance of economic interests Less acceptance of economic interests Emphasise consumer protection Emphasise state and industry Responsibility Negative view - create public anxiety Positive view – reliable Media Not acknowledged by all institutions – source of negative perceptions Inherent in science Uncertainty Krystallis et al, 2007, Health, Risk & Society

4. Some basics about risk perception by consumers • Losses have greater impact on attitudes than gains (Kahneman and Tversky, 1979). • People weigh risk information as more important than benefit information • Impact of balanced information higher on risk perception than on benefit perception (Fischer and Frewer)

5. Risk perception in food technologies • Consumer attitudes to new food technologies “not starting from zero”– food has always been there not like pharma • Consumers make trade-offs between risk, benefit and cost (including ethical & environmental costs) • Consumer decisions are made on a case-by-case basis related to specific perceptions of risk and benefit Consumers’ decisions and perceptions might be (very) far from a rationale science-based approach

6. EU Consumers’ resistance to GMOs [Eurobarometer 2006]

7. Consumer resistance [Eurobarometer 2006]

8. What went wrong with GM food • Resistance based on perceived risk • GM food perceived as unnatural and therefore risky • Uncontrollable by those exposed to them • Food is a special cause of concern (taken into the body) • Unknown long-term risks • Substantial equivalence did not address consumer concerns • Opaque risk analysis systems and decision-making practices were not helpful • Resistance based on values and benefit analysis • Consumer choice issue: has to do with marketing more than with ideology(“who wants what and why?”) • Food a special issue in Europe • No consumer benefits from the 1st generation of GMOs • Who is getting the final benefits (Third Countries farmers? Biotech companies?) • Impact on biodiversity • Ethical doubts

9. The EU legislative framework as an attempt to respond to consumers’ resistance

10. The objectives of the European Legislation • Managing possible risks • Foster innovation • Protect consumers’ right to know and choose • Avoid trade barriers

11. After the food scandals of the 90s a new regulatory framework

12. The EU model approach • RA and RM as separate steps • Risk assessment: European Food Safety Authority • Risk management: European Commission through a regulatory committee procedure • A fully transparent process open to 27 MS of the EU and to more than half a billion EU citizens

13. EFSA risk assessment • Fully independent from the political level • RA based on international standards • Some of the best scientists in the EU selected ad hoc (GM Panel + expert + EFSA staff) • The three typical steps of RA • Compositional analysis • Food and feed safety analysis • Env. impact analysis • + a wide consultation with 27 MS scientific bodies • Defined as the most comprehensive (and longest) RA process in the world

14. Risk management phase EFSA’s Final opinion Commission Proposal of Decision Comm. / EFSA MS Working group Comments from The public Standing Committee (SCFCAH – GMFF) Opinion, 3 months after EFSA’s opinion Commission Against, QM In favour, QM No Opinion No opinion / In favour, QM Council, 3 months Commission decision - Publication in OJ • Inclusion in GMO register Against, QM Commission to redraft the proposal

15. Elements to reassure consumers • Authorisation • Granted for 10 years • Can be reviewed/withdrawn at any moment • Renewable for 10-year periods • Always for food and feed (no Starlink case in the EU) • Authorization holder responsible for safety, post market monitoring • Authorised products are entered in the Community register containing all relevant info http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

16. Consumer information - labelling • Compulsory for food/feed contain, consist of, produced from GMOs regardless of the presence of modified DNA or proteins • In the list of ingredients if pre-packaged • Otherwise visible if non pre-packed • 0,9% threshold for adventitious presence of authorised GMOs (operators responsible to take measures) • Lower levels may be adopted via comitology • National provision for GM-free labels and for menus • NOT for products obtained from animals fed with GM feed or treated with GM medicines (eggs, milk, meat) but the issue is becoming more and more important and often addressed at private level

17. More than 25 GMOs authorised in the EU 10 new GM food and feed authorised under the new regulatory framework (not for cultivation) 55 requests pending (15 cultivation) EU: second in the world for number of GM authorisations granted ….and yet EU consumers perception is rather negative although gradually improving Consequences of the EU legislation

18. Winning consumers’ trust by improving what the way we do what we do • Shared guidelines for RA (Comm, EFSA, MS in consultation with stakeholders) • An evaluation of the existing legislation • The risk assessment and regulatory approval process • The labelling rules on GM food and feed • Consumers’ acceptance • Discussion on integrating other legitimate factors in the author. process

19. Conclusions • Consumers have views which are the result of different factors and might diverge from scientific objectivity • Scientists should keep delivering the best possible independent risk assessment • Policy makers: not just implementer of science but a bridge between consumers and scientists • The EU model tries to apply this approach • Results have been encouraging but more time and more action is needed • Finding the right balance on this and other controversial issues might imply re-thinking our approach to policy making

20. Thank you!!!!!! Marco.Valletta@ec.europa.eu