1. Romanian framework concerning GMOs Dr. Valeria GAGIU Institute of Food Bioresources 6 Dinu Vintila Street, 021102, 2 nd district, Bucharest ROMANIA Tel. +040.21.211.36.39, Tel./Fax: +040.21.210.91.28 E-mail: inraa@bioresurse.ro Website: www.bioresurse.ro

2. ORGANIZATIONAL FRAMEWORK NATIONAL COMMISSION FOR BIOSAFETY (Order no. 684 of 5 August 2002) ENVIRONMENT AND WATER ADMINISTRATION MINISTRY SANITAR VETERINARY and FOOD SAFETY AUTHORITY (ANSVSA) HEALTH MINISTRY NATIONAL AUTHORITY OF CONSUMER PROTECTION AGRICULTURE, FORESTS and RURAL DEVELOPMENT MINISTRY

3. GMOs LEGISLATION IN ROMANIA  09.11.2005 – Project for Decision regarding transborder transport of GMOs, according Law no. 52/2003 regarding decisional transparence in public administration. Order no. 923/2005Order no. 923/2005, regardind approval of Presentation form for notification sumary regarding placing on the market of GMOs, consisting of or produced from GMOs. Order no. 923/2005 Order no. 838/2005Order no. 838/2005, for approval of the guidebook regarding applying of Annex no. 12 “Monitoring plan” of Government Decision no. 49/2000 regarding obtaining, testing, using and trading of GMOS by modern biotechnology, as well as products obtained by these, approved with changes by Law no. 214/2002 Order no. 838/2005 Order no. 606/2005Order no. 606/2005, regarding approval of Presentation Form for results of deliberate release into the environment of genetically modified higher plants, for any other purpose than for placing on the market. Order no. 606/2005

4. for ratification of Cartagena Protocol on Biosafety, signed on 29.01.2000 at Montreal, M.O. 192/26.03.2003 Law no. 59/11.03.2003 for ratification of Cartagena Protocol on Biosafety, signed on 29.01.2000 at Montreal, M.O. 192/26.03.2003 Law no. 59/11.03.2003 Law no. 214/19.04.2002Law no. 214/19.04.2002 for approval of Government Ordinance no. 49/2000 regarding obtaining, testing, using and trading of GMOs by modern biotechnology, as well as products obtained by them, M.O. 316/14.05.2002 Law no. 214/19.04.2002 Law no. 58/13.07.1994Law no. 58/13.07.1994 for ratification of Convention for Biological Diversity, M.O. 199/2.08.1994 Law no. 58/13.07.1994

5. Order no. 684/5.08.2002Order no. 684/5.08.2002 regarding approval of National Commission for Biosafety structure and Regulation for Structure and Operating, M.O. 793/31.10.2002 Order no. 684/5.08.2002 Order no. 462/15.07.2003Order no. 462/15.07.2003 regarding the evidence of economical agents which cultivate GM plants, M.O. 542/29.07.2003 Order no. 462/15.07.2003 HG nr. 106/7.02.2002HG nr. 106/7.02.2002 regarding food labelling, Annex no. 3 - Methodological norms regarding additional informations which must be indicated by label or contain GM additives and flavours, M.O. 407/12.06.2002 HG nr. 106/7.02.2002 Law no. 86/10.05.2000Law no. 86/10.05.2000 for Ratification of information access, public participation to decision and access to justice in environmental problems, signed at Aarhus on 25 June 1998, M.O. 224/22.05.2000. Law no. 86/10.05.2000

6. Food Safety National Measures Ministry of Agriculture founded Romanian National Food Safety Authority (ANSVSA) since September 2003. This Authority is autonomous and has 42 representatives county and a large number of accredited laboratories, very well equipped and prepared for quality assessment of animal origin food and has also an ongoing project for developing the non- animal origin sector.

7. Food Safety legislative implementation by ANSVSA – National Food Safety Authority New approaches in food safety: Food chain – “from fork to farm” and “from farm to fork”; Control systems on the basis of risk assessment; Prevention approaches and risk communication strategies; Development of the capacity concerning traceability and reaction capacity in crises (contingency management).

8. National R & D Program Biotechnology (BIOTECH) National R & D Program Biotechnology (BIOTECH) 2001 – 2003 Subprogram 8 - Analysis, control and quality assurance of biotech substances and products; prevention of risks implyed by producing and use of them 2004 – 2006 Subprogram 5.2. – Subprogram 5.2. – Control of the biotech process and products and prevention of risks implyed by producing and use of them

9. INSTITUTE OF FOOD BIORESOURCES NATIONAL PROGRAMME “ BIOTECH” Project „ANALYTICAL CONTROL OF PROTEINS CP4 EPSPS FROM SOYBEAN AND Cry1Ab FROM MAIZE, USING IMMUNOENZIMATIC METHODS” (2004 – 2006). Main goal: accreditation of 2 methods (immunostrip; ELISA) for detection of genetically modified proteins from RUR soybean and MON810 maize. Expected results: Quality assurance for detection of GM proteins; Quality assurance for detection of GM proteins; Validation of immunoenzimatic methods; Validation of immunoenzimatic methods; Accreditation by RENAR (till Oct. 2006) - accordingly Accreditation by RENAR (till Oct. 2006) - accordingly EN ISO 21572:2004 “Foodstuffs. Methods for the detection of genetically modified organisms and derived genetically modified organisms and derived products. Protein based methods” and products. Protein based methods” and EN ISO/CEI 17025:2000 “General requirements for the competence of testing and calibration laboratories” of testing and calibration laboratories”

10. Notification for Notification for authorisation of deliberated releases into environment for field testing of Redsec potato variety genetically modified for resistance to Colorado beetle (Annex 8B law 214/2002). Risk evaluation for environment. Monitoring plan. This institution meet requirements for accreditation of GMOs detection by PCR, but its activity is only for research. of Banat from Timisoara University of Agricultural Science and Veterinary Medicine of Banat from Timisoara

11. FUTURE APROACHES to improve knowledge on GMOs – training of staff; to improve infrastructure of laboratory; to get new financial resources by:  National R&D Program BIOTECH;  National R&D Program CEEX ;  International Programs (FP6; Phare; Sapard).

12. Thank you !