1. Jens Högel Biotechnologies, Agriculture & Fisheries, Food Directorate-General Research and Innovation European Commission GMO biosafety research and related EU activities under FPs Kyiv, Ukraine 20 April 2012

2. Cooperation programme – thematic areas (€ million)

3. FP7 Biotechnology research areas Novel sources of biomass and bioproducts Energy/industrial crops, bioactive compounds, biomass availability Marine and fresh-water biotechnology Bioactive compounds, algae, biosensors Industrial biotechnology Microbs and enzymes in industry: chemicals, pulp and paper, pharma int., cosmetics,… Biorefinery 2 nd generation biofuels, biochemicals and biomaterials - Biowaste Environmental biotechnology Environ. technologies, bioremediation, ecosystems functioning, GMO assessment Emerging trends in biotechnology Synthetic biology, bioinformatics, nano-biotechnology, etc

4.  Mitigation of and adaptation to climate change effects in primary production Improving plant biology and adapt to changing environmental conditions  Greening the industry Increasing sustainability and efficiency of industrial processes Low carbon processes: renewable carbon Monitor and remediate pollution to the environment Keeping the lead of the EU biotech industry  Ensure oceans for the future Sustainable exploitation of our rich marine and aquatic biodiversity  Improve food security and safety for EU and beyond  Build a social inclusive Europe Safety, ethics, societal acceptability, governance FP7 Biotechnology objectives

5. EU FP research on GMOs 1985 - 2000 Key figures  81 projects presented  Focus on  Effects of gene transfer and flow  Effects on non-target organisms  Plant-microbe interactions and soil quality  Biocontrol of fungal plant pathogens  Food safety and risk assessment tools  Bioremediation  GM animals and vaccines  EC budget > 70 million Euros http://ec.europa.eu/research/quality-of-life/gmo/

6. EU FP research on GMOs 2001 - 2010 Key figures of the new publication  50 projects presented  Projects part of CORDIS database  Focus on  Environmental impacts  Food safety  Biomaterials and Biofuels  Risk assessment/management and policy support/communication  EC budget > 130 million Euros  No major risks identified over the 25 years http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf

7. Projects on environmental impact EURICE (2000-2003)  Transgenic EU rice varieties most resistant to rice blast fungi (Magnaporthe grisea) were developed by inserting antifungal genes from Aspergillus and giant silk moth Hyalophora cecropia together with inducible promoters. ECOTUB (2000-2003)  Development of selection markers based on plant tubulines and eliminating the need for introducing alien species genes as selection markers (e.g. conferring antibiotic resistance). ECOSAFE (2001-2003)  Development of engineered bacteria (Azospirillium) stimulating root growth and nitrogen uptake of plants. Field trials did not show any adverse environmental effects of the engineered strain. Studies on cell- cell communication (plants-soil bacteria) generated substantial body of knowledge in relation to future biocontrol/biofertiliser bacteria.

8. BT-Bionota (2000-2003)  Examination of Bt transgene effects on biodiversity of non-target insects. With one exception, no major differences in parasitoid behaviour, parasitation rate and adult longevity were observed. ProBenBT (2002-2006)  The project provides solid data for sustainable management of Bt-maize in the EU, reducing the risk of evolution of Bt-resistance in target insects. Methodology was developed allowing the identification of Bt-resistance genes in target insects for monitoring purposes. ECOGEN (2002-2006)  Ecological and economic assessment of effects of Bt- and HT-crops on the soil environment. Effects of GM crops on soil ecology not detected or less pronounced than effects resulting from crop variety or changes in agricultural practices. Economic assessment in favour of the GM crops investigated. Projects on environmental impact

9. GMOBILITY (2000-2003)  Quantification of the risk of HGT from GMO to food chain microbes and human gut microflora, using nptII. Concluded that HGT in general possible, but due to other factors (GI environment, low copy numbers of transgenes, inhibiting components in the GI tract and in the foodstuff etc.), transfer of nptII to microorganism, rats and on a basis of a model system was not detected. ENTRANSFOOD (2000-2003)  Network of research groups focussing on scientific and societal issues of introducing GM crops in the EU. Detection of unintended effects of GMOs should continue to be based on targeted approaches, measuring single compounds. Marker genes available at that time (incl nptII and hpt) were not considered to pose additional environmental or health risks. Projects on food safety

10. GMO topic in WP 2011  “Assessing and monitoring Impacts of Genetically Modified Plants On Agro- Ecosystems”  Budget: € 6 Million, consortium of 22 partners  Expected results –Network of representative sites for ERA/PMEM in the EU –Catalogue of selected bio-indicators –Harmonised sampling and testing methods –Field trials comparing GM/non-GM plants in terms of environmental/economic performance –Communication work package  Aims to faciliate work of EU risk assessors and decision makers  Project started December 2011, runs until December 2015

11.  “Verification of GMO risk assessment elements and review and communication of evidence collected on the biosafety of GMO”  Budget: € 6 Million, up to one project, under negotiation  Expected outputs –Comprehensive review of national, EU and international research activities, setting-up an open-access database and a continous review process and related procedures –Verifying animal feeding trials of already authorised GMO –Developing in-vitro systems to reduce animal use in GMO applications –Communication work package  Increasing awareness of existing evidence in terms of risks and benefits of GMO  Enhance confidence of consumers and EU policy makers in current EU approaches to GMO risk assessment GMO topic in WP 2012

12. EU GMO risk assessment process

13. EU authorized GMO Status Quo EU (as of April 2011)  According to DG SANCO 49 GMOs authorized in the EU for food/feed use –29 GM maizes –8 GM cottons –7 GM soybeans –3 GM oilseed rape –1 sugarbeet and 1 potato  Also 2 GMOs authorized for food/feed use and cultivation –MON810 –Amylopectin potato (Amflora) For further information please consult http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

14. Source: EMBO reports Vol 11 / No 4 / 2010, pp. 1-5;

15. EC Contacts & Information Any remaining questions or comments please contact : jens.hoegel@ec.europa.euens.hoegel@ec.europa.eu EC DG RTD, Dir. E. Unit E2 “Biotechnologies”, Head of Unit: Dr. Alfredo Aguilar Romanillos alfredo.aguilar-romanillos@ec.europa.eu