1. EU legislation on GMOs: Overview and challenges Euro Coop Sustainability Working Group 27 October 2010 Sébastien Goux Unit Biotechnologies

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. Regulation on Food and Feed: a fully integrated approach GM SEEDS GM FOOD - containing or consisting of GMOs -produced from GMOs GM FEED - containing or consisting of GMOs - produced from GMOs ENVI Risk Food/Feed Risk

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

5. Authorisation aspects Panels & Units GMO GMO Applications http://efsa.europa.eu

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

7. Biotechnology GM Food & Feed http://eu.europa.eu/food Community Register of GM Food and Feed

8. GMO authorised for cultivation Maize MON810 Amflora Starch potato

9. The EU legislative framework on GMOs is under tension

10. The societal debate Eurobarometer 64.3 (2006)

11. Bt maize yields v conventional maize in 3 regions of Spain (JRC-IPTS study) Surface(2005)7957 ha16830 ha21259 ha Surface (2007)3659 ha23013 ha35860 ha Evolution-54 %+ 37%+ 68%

13. GM feed: A set of actions regarding the issue of asynchronous authorisations Within the EU Streamlining the authorisation procedure Harmonisation of controls Evaluation of the legislative framework At International level

14. New approach on cultivation: Strategy in two steps

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

16. 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 international obligations

17. Looking ahead – Major challenges  Cultivation –Implementation of new Commission approach Co-existence => Organic, non-GM and GM Restrictions by Member States  Evaluation of EU GM legislative framework  Societal/Political debate –Responsible innovation  Safety: Food, Feed & Environment  Economic impacts  Debate on labelling requirements –Use of GM feed –GMO free

18. Thank you !