1. Geneticaly modified Food and Feed – current situation in EU Petr Beneš Food Safety Department Prague, 9 October 2009

2. Content Role of the Food Safety Department Legislation Authorisation process Actual information

3. Definition of GM Food and Feed Food containing, consisting or produced from GMO´s Feed containing, consisting or produced from GMO´s

4. Food Safety Department Administration of applications Participation in SCoFCAH meetings Scientific Committee on GM food and feed

5. Legal framework by April 2004Directive 2001/18/EC Regulation (EC) No 1829/2003 of the EP and of the Council Regulation (EC) No 1830/2003 of the EP and of the Council

6. Regulation (EC) No 1829/2003 of the EP and of the Council valid since April 18, 2004 covers use of GMO´s for food and feed sets up centralized authorisation procedure sets up labeling requirements and limits for adventitious or technically unavoidable presence of genetically modified materials in a food or feed

7. Regulation (EC) No 1829/2003 of the EP and of the Council valid since April 18, 2004 covers use of GMO´s for food and feed sets up centralized authorisation procedure sets up labeling requirements and limits for adventitious or technically unavoidable presence of genetically modified materials in a food or feed

8. Authorisation procedure Who participates in Authorisation of Applications? - European Food Safety Authority (EFSA) - EU member states (MS) - European Commission (EC)

9. „GM food and feed should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard, to be undertaken under the responsibility of the European Food Safety Authority, of any risks which they present for human and animal health and, as the case may be, for the environment.“ Point (9), Regulation (EC) No 1829/2003 European Food Safety Authority (EFSA)

10. Standing Committee on Food Chain and Animal Welfare All MS express their positions during voting Qualified majority must be achieved in favour / against the draft Commission Decision If no qualified majority is achieved, the draft is submitted to the Council for decision If no decision is adopted by the Council, the Commission is authorised to make the decision

11. National Competent Authority European Food Safety Authority (EFSA) risk assessment final opinion Application according No 1829/2003 Comunity Reference Laboratory (CRL) European Net of GMO laboratories (ENGL) method validation European Commision draft decision different decision against EFSA´s must be explained Standing Committee on Food Chain and Animal Health member countries qualified majority (QM) Council of Ministers 90 days for decision (SCoFCAH without QM) Approval / disapproval of Application 6 months for validation 3 months 6 months QM without QM 3 months decision EU member countries consultation 3 months Public comments 30 days Official Journal Register of GM food and feed

12. Support of GM food and feed – current situation in EU Positions of some MS reflect political situation… X The main criterium for EC decision making is the result of the scientific risk assessment

13. Support of GM food and feed – current situation in EU Bulgaria Czech Republic Estonia Finland Netherlands Slovakia UK Spain Sweden Cyprus Luxemburg Hungary Poland Austria Greece Malta Slovenia

14. Regulation (EC) No 1829/2003 of the EP and of the Council valid since 18. April 2004 covers GMO usage in food and feed sets up centralized authorisation procedure sets up labeling requirements and limits for adventitious or technically unavoidable presence of genetically modified materials in a food or feed

15. Labeling of products with GMO´s a) the content of GM parts is less than 0,9 % - only in case the presence is adventitious or technically unavoidable X b) wilful added GM parts

16. Labeling of foods of animal origin obtained in animals fed by GM feed? NO! -NO labeling requirements for milk, meat, eggs... etc. -NO traceability requirements applicable

17. Regulation (EC) No 1830/2003 of the EP and of the Council harmonized framework for the traceability transmission of written information between operators holding of information (5 years from each transaction) labeling requirements + Commission Regulation (EC) No 65/2004 inspection and control measures

18. Any source of GMO unique identifiers? development of the unique identifiers according to Commission Regulation (EC) No 65/2004 BioTrack database (OECD) http://www2.oecd.org/biotech/byIdentifier.aspx

19. Up to date number of applications 72 applications presented at 30. 9. 2009 60 % applications on maize applications presented by (only) seven countries: NL, UK, DE, FR, CZ, BE, DK

20. Community register of GM products Publicly available on European Commission web pages: http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

21. Community register of GM products http://ec.europa.eu/food/dyna/gm_register/index_en.cfm http://ec.europa.eu/food/dyna/gm_register/index_en.cfm Presently 27 products: –12x GM maize –6x GM cotton –3x GM rape –2x GM yeast, bacteria –3x GM soya –1x GM sugar beat

22. Products withdrawn from the market GM rape hybrids -Ms1xRf1, Ms1xRf2, Topas 19/2, GM maize hybrids -Bt176, GA21xMON810 http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

23. Asynchronous release of GM food and feed different duration and demandingness of authorisation process in EU and third countries „zero tolerance“ of presence of non-authorised GMO´s in feed = source of problems

24. GM maize cultivation – current situation in EU GM maize is cultivated in: Spain, Czech republic, Portugal, Slovakia, Romania National bans on cultivaton: Germany, Austria, France, Greece, Hungary, Lucemburg

25. Information on GMO Ministry of Agriculture web pages (in CZ only) –www.mze.cz - section „Zemědělská výroba“ – category „GMO-geneticky modifikované organismy v zemědělství“www.mze.czGMO-geneticky modifikované organismy v zemědělství –www.mze.cz - section „Potravinářská výroba“ – category „Bezpečnost potravin“ – „Geneticky modifikované potraviny a krmiva“www.mze.czGeneticky modifikované potraviny a krmiva Ministry of Environment web pages: –www.mzp.cz/en - section „Environmental Risks“ – category „GMO“www.mzp.cz/enGMO

26. Thank you for your attention! petr.benes@mze.cz