The GMO Approval Process in Europe : failures and opportunities

1. The GMO Approval Process in Europe :failures and opportunities Eric Gall Policy Advisor Greenpeace European Unit Rue Belliard 199 Brussels, Belgium www.eu.greenpeace.org GMO-free Regions Conference Berlin, 14-15 January 2006

2. Overview • GMOs approvals : undemocratic and untransparent • Poor assessment by EFSA • The case of GM maize MON863 • Political opportunities

3. GMO approval An undemocratic authorisation process GMO application to member state Source : Presentation by Benedikt Haerlin, first GMO-free Regions conference Assessment by national authority EFSA assessment & recommendation Commission proposal Vote in Standing Committee Qualified majority! Vote in Council of Ministers Commission approval Seed law Inscription of GM varieties in national seed catalogue Inscription in Common Seed Catalogue of the EU Exemption of specific variety for individual country

4. An undemocratic authorisation process The authorisation process makes it extremely difficult to reject a GMO authorisation

5. Approvals since May 2004 • Syngenta’s Bt 11 sweet maize approved on the 19 May 2004, for import (6 MS against, 6 in favor, 3 abstentions) • Monsanto’s Roundup Ready Maize NK603 authorised on 19 July 2004 for import and processing (9 against, 11 in favor, 5 abstentions)

6. Approvals since May 2004 • Monsanto’s Bt Maize MON 863 authorised on 8 August 2005 for import and feed (14 against, 7 in favor, 4 abstentions) • Monsanto’s oilseedrape GT73 authorised on 31 August 2005 for import and processing (13 against, 6 in favor, 6 abstentions) • Pioneer’s Maize 1507 authorised on XXX 2005 for import and feed (10 against, 9 in favor, 6 abstentions)

7. Approvals since May 2004 • Monsanto’s Bt Maize MON 863 authorised on 13 January 2006 for food (11 against, 11 in favor, 3 abstentions) • Monsanto’s RR Maize GA21 authorised on 13 January 2006 for food (11 against, 11 in favor, 3 abstentions) • Monsanto’s Bt Maize MON 863xMON810 authorised on 13 January 2006 for food (14 against, 8 in favor, 3 abstentions)

8. Evaluation by EFSA • European Food Safety Authority set up in 2002 • Assessment based on the company’s data • No transparency (confidential studies) • No long term evaluation • Weak monitoring requirements • Diverging opinions and scientific uncertainties • Lack of independence from industry • EFSA plays a central role in the new centralised procedure, under which most applications have been transfered (Regulation 1829/2003)

9. Evaluation by EFSA Lack of transparency, and the EFSA does not implement properly the legal requirements on the evaluation of GMOs

10. The case of MON 863 • On 23 April 2004 the French newspaper Le Monderevealed that the French expert body in charge of GMO evaluation has expressed doubts about the safety of GM maize Mon 863 (rat study: increased number of white blood cells in the males, reduced immature red blood cells in females, a significant increase in blood sugar in the females or a higher frequency of physical irregularities in the kidneys of the males, such as reduced weight and inflammation, with rats fed MON863) • On 5 May 2004, Greenpeace wrote to the German agriculture ministry, which was in charge of the initial risk assessment report, to request access to the full documents concerning Mon 863.

11. The case of MON 863 • On 4 August 2004, the German agriculture ministry replied that the applicant, Monsanto, had refused to agree to publish the initial rat study MSL-18175, which had been classified as “confidential business information”. • On 21 March 2005, the German authority decided to give access to the full document, because Monsanto could not show that its request for confidentiality was backed by EU or national law. • On 27 April 2005, Monsanto filed an appeal against the decision of German government and, in addition, took out an injunction to stop the authorities publishing the data.

12. The case of MON 863 • On 9 June 2005, the German court decided to reject Monsanto's request; the data could not be seen as confidential, the right of society to transparency had to be given more weight than Monsanto's economic interests. The company appealed the decision. • On 20 June, the court rejected the appeal, and ruled that the documents be made public. • Press conference in Berlin • On 24 June, at the Environment Council in Luxembourg, 14 ministers voted against the authorisation of MON863 in feed (7 voted in favor, 4 abstained). • On 8 August, despite Greenpeace warnings and EU ministers votes, the Commission authorised MON863 for import and use in feed. According to the undemocratic “comitology rules” used to approve GMOs, the Commission can put GMOs on the market even if a simple majority of governments is against.

13. The case of MON 863 • On 20 October, Greenpeace publishes a preliminary report on the toxicity study performed on rats by Monsanto. The report, written by Professor Gilles-Eric Séralini, strongly criticises the method that was used in the company’s own study to assess the apparent negative impacts on the health of the group of rats fed the modified maize, and the way that anomalous findings were dismissed. It concludes that “It is essential for Monsanto's entire statistical analysis to be repeated before any decision about market access is taken.” The report is sent to the Commission (DG Sanco). • On 24 October, 11 Agriculture ministers voted against the authorisation of MON863 for food uses (11 voted in favor, 3 abstained).

14. The case of MON 863 • On 16 December, the Commission replies that “since the Council neither adopted the proposed measures [to authorise MON863] nor indicated its opposition to them, the Commission is in the process of adopting the proposed measures according to Community legislation”, and that they have forwarded our letter to EFSA “in order to inform the authority about [our] comments”. • In November and December, around 10 000 EU citizens sent letters through email to Commissioner Kyprianou (DG Sanco), asking him not to authorise MON863 and to order a new and independent analysis of the rat study data. • On 13 January, final approval by the Commission.

15. Applications in the pipelineto be voted on • GM maize 1507 for food • GM maize MON863xNK603 for food, feed, import and processing (food committee) • GM maize MON863xMON810xNK603 for food, feed, import and processing (food committee) • GM maize 1507 for import, processing and cultivation (2001/18 committee, now on hold at Commission’s level, leading country Spain) • GM maize Bt11 for import, processing and cultivation (both field and sweet maize, 2001/18 committee, now on hold at Commission’s level, leading country France)

16. Applications in the pipelineEFSA opinion pending • GM Rice LL62 for import, processing and feed (2001/18, UK) • GM Rice LL62 for import, processing, food and feed (2001/18, UK) • GM OSR Ms8xRf3 for import, processing, feed and cultivation (2001/18, Belgium, Bayer apparently agreed to restrict it to import) • GM maize NK603xMON810 for import, processing and feed (2001/18, UK) • GM maize NK603xMON810 for food and feed (1829/2003, UK) • GM starch potato from BASF for import, processing, feed and cultivation (2001/18, Sweden) • GM cotton stacked line for import and processing (2001/18, Netherlands)

17. Applications in the pipelineEFSA opinion pending • Moonlite cut flowers from GM carnation for import, distribution and retailing (2001/18, Netherlands) • GM maize 1507xNK603 for import, processing, food and feed (1829/2003, UK) • GM cotton LL25 for import, processing, food and feed (1829/2003, UK) • GM amylopectin potato from BASF for food and feed (1829/2003, UK) • GM sugarbeet H7-1 for food and feed (1829/2003, UK) • GM cotton MON531xMON1445 for food and feed (1829/2003, UK) • GM cotton 24-236/3006-210-23 for food and feed (1829/2003, Netherlands)

18. Applications in the pipelineAssessment report pending • GM cotton MON15985xMON1445 for food and feed (1829/2003, UK) • GM maize MIR604 for import, processing, food and feed (1829/2003, UK) • GM maize 59122 for import, processing, food and feed (1829/2003, Netherlands) • GM maize 1507x59122 for import, processing, food and feed (1829/2003, Netherlands) • GM maize 1507xNK603 for import, processing, food, feed and cultivation (1829/2003, UK) • GM soya A2704-12 for import, processing, food and feed (1829/2003, Netherlands) • GM maize GA21 for import, processing, food and feed (1829/2003, UK)

19. Political situation

20. Political situation • Policy debate on GMOs at the Environment Council 2 December 2005 • Respect for simple majorities in the Council • EFSA to take into account MS concerns and the precautionary principle • (Co-existence legislation)

21. Political situation • Good guys : Austria, Italy, Poland, Hungary, Greece, Luxembourg, Cyprus, Slovenia, Malta, Lithuania • Spain, Belgium, DK, Latvia, Slovakia • Bad guys: UK, Sweden,France, Germany, Netherlands, Czech Republic, Ireland, Portugal, Estonia, Finland

22. Faced with a global rejection of GM crops, the US, together with Canada and Argentina, have started legal procedures at the World Trade Organisation (WTO) against the EU de facto moratorium on new GMO authorisations. After three delays, the result is now expected in February 2006 Protest against US at WTO headquarters

23. Political situation • Commission ’s reports on the implementation of the legislation (January/February) • 9 March Environment Council : possible policy debate on GMOs; Hungarian ban(?) • 22-23 May : Agriculture Council, EFSA, Coexistence (?), review of implementation of the legislation • April/May : Commission ’s debate • June Environment Council (?)

24. Suggestions for actions

25. Suggestions for actions 1) Convince Regions and national governments to demand : • Stop authorisations of GMOs until the implementation of the EU GMO legislation is reviewed (respect for simple majorities) • More transparent, independent and stricter evaluation of GMOs (re-organisation of EFSA) • Right to ban GMO cultivation 2) Lobby national Commissioners

26. Say NO to GMOs ! www.greenpeace.org