1. EU legislation on GMOs: Overview and challenges Alberto Volpato, Counsellor for Health, Consumers, Agriculture Presented by Guy Van den Eede, Adviser for the Bio-Economy (DG Joint Research Centre)

2. EU legislation on GMOs Safety -Each GMO MUST be authorised Information Labelling -All GM food containing or produced from GMOs (e.g. oil, sugar) -All GM feed containing or produced from GMOs

3. Directive 2001/18 Deliberate release of GMOs ENVI Risk CULTIVATION Import & processing

4. Regulation 1829/2003 Integrated approach of the Food/Feed chain Food/Feed Risk GM SEEDS GM FOOD - containing or consisting of GMOs -produced from GMOs GM FEED - containing or consisting of GMOs - produced from GMOs OTHER USES ENVI Risk

5. Two interacting framework legislations Directive 2001/18/EC Regulation 1829/2003 GMOs not for food /feed use, ie GM carnation Food/feed consisting of or containing a GMO Food/feed produced from a GMO

6. Authorisation procedure Appl. Product development Dossier/Risk assessment/Detection EFSA Risk assessment Questions to applicant COM Authorisation: Yes/No + conditions Comitology

7. Authorisation procedure after EFSA opinion Commission proposal (public comments) Vote by MS (Scfcah) -Qualified majority: adoption -No qualified majority: COM may convene an Appeal Committee Vote in Appeal Committee: -No: no authorisation -Yes: authorisation -No qualified majority: COM may adopt

8. WTO aspects The EU authorisation system is compatible with the SPS agreement Notifications under SPS agreement: -All measures related to the authorisation system (i.e. Future draft Regulation on feed and food applications) -Emergency measures Notifications under TBT agreement: -Labelling and traceability

9. 47 GMOs authorised for food/feed use (+ 5 obsolete) -26 maizes- 1 sugarbeet -6 soybeans- 3 oilseed rapes -8 cottons- 1 potato -2 microorganisms 2 GMOs authorised for cultivation: -MON810 maize -“Amflora” starch potato Current status of authorisations in the EU

10. Pending applications 22 GMOs are pending for cultivation and/or food/feed uses Only 1 GMO is pending for cultivation 44 GMOs are pending for new authorisation for food and feed uses 11 GMOs are pending for renewal of the authorisation for food and feed uses

11. The EU legislative framework on GMOs is under tension

12. The societal debate Eurobarometer 64.3 (2006)

14. 3 types of « Non-authorised » GMOs Not authorised in any country (authorisation restricted to field trials) « Asymmetric » : authorised in third country but not foreseen in EU “Asynchronous”: in the pipeline for authorisation in EU but authorised elsewhere

15. Non authorised GMOs : some concrete examples Not authorised in any country Bt 10 maize: US 2005, emergency measure LLRice 601: US 2006, emergency measure Rice Bt Kefeng6 & KDM1: China 2010… Asymmetric Linseed 967: LLRice 601, Bt63 Rice Asynchronous Maize 59122, GA21, MIR604: Now authorised

16. “Technical solution for LLP feed” Regulation (EC) 619/2011 Harmonisation of controls for GMOs in case of asynchronous authorisation Prerequisites -Pending valid application with EFSA -Authorised in a non EU country -Validated quantitative detection method -Certified Reference Material available

17. GM rice from Chinese origin Number of RASFF/year

18. Addressing the societal challenges Conclusions of the ENVI Council of December 2008 calling for the appraisal of the socio-economic benefits and risks of GMO cultivation Joint letter of 13 Member States in 2009 calling for more flexibility in the decision to cultivate or not GMOs on their territory

19. The New approach on cultivation: Strategy in two steps

20. New Recommendation on coexistence Non binding act More flexible guidance to Member States on how to avoid presence of GMOs in other products

21. Proposal for an EP and Council Regulation modifying Directive 2001/18/EC Objective -To provide a legal base for MS which want to ban or restrict cultivation of authorised GMOs Conditions -Not linked to safety -In agreement with EU law and WTO

22. Looking ahead – Major challenges Cultivation -Current negotiations at Council under DK Presidency -Implementation of Recommendation on co-existence Labelling -GMO free: launch of an exploratory study to assess the need for harmonisation in this field – should be finalised by end 2012 Low-level presence for food -Commission is examining the implementation of the LLP feed Regulation and this analysis could lead to a discussion in the near future on an extension of scope to cover food.

23. Looking ahead – Major challenges Environmental risk assessment & post-market monitoring: -Process to revise the guidelines for environmental risk assessment of GMOs, objective to make those guidelines legally binding -Commission plans to issue a Recommendation for MS on monitoring in 2012 ; and presentation of the initial ideas at a COM conference on 29.03.2012 Draft Regulation on GM feed and food applications for authorisations -Objective to have an endorsement by Member States of the elements for the risk assessment -Adoption scheduled for the summer