1. EFSA Organization & Procedures for GMO Risk Assessment EFSA Organization & Procedures for GMO Risk Assessment Yi Liu Scientific officer Taiex workshop on biosafety AGR 46779 Kiev, 19-20 April 2012 Committed since 2002 to ensuring that Europe’s food is safe

2. 2 Committed since 2002 to ensuring that Europe’s food is safe Today’s talk will cover EFSA remit & organization Risk assessment of GMOs at EFSA EFSA procedure for GMO applications

3. 3 Committed since 2002 to ensuring that Europe’s food is safe What EFSA does EFSA was set up in 2002 following a series of food crises in EU, to provide an independent source of scientific advice, risk assessment and risk communication on risks associated to food chain, animal health and plant health. Source: Regulation (EC) No 178/2002  Independence Risk assessment separated from risk management  Openness and transparency  Scientific excellence  Responsiveness

4. 4 Committed since 2002 to ensuring that Europe’s food is safe EFSA cannot  Be responsible for food safety legislation  e.g. EFSA does not give authorisations for new products such as GMOs, feed additives, food additives, pesticides, etc.  Take charge of food safety/quality controls (sampling), labelling or other risk management issues such as co-existence measure  Act as a substitute for national authorities

5. 5 Committed since 2002 to ensuring that Europe’s food is safe EFSA staff about 450

6. 6 Committed since 2002 to ensuring that Europe’s food is safe EFSA External Experts – Scientific Committee and Panels  Food additives and nutrient sources (ANS)  Food contact materials, enzymes, flavourings (CEF)  Feed additives (FEEDAP)  Genetically modified organisms (GMO)  Nutrition (NDA)  Plant protection products (PPR)  Biological hazards (BIOHAZ)  Contaminants (CONTAM)  Plant health (PLH)  Animal health and welfare (AHAW) Mainly opinions on applications Mainly generic opinions Horizontal scientific issues  Scientific committee (SC)

7. 7 Committed since 2002 to ensuring that Europe’s food is safe European Neighbourhood Policy The European Neighbourhood Policy (ENP) aims to forge closer ties with countries to the South and East of the EU. Through this policy, the EU seeks to promote greater economic development, stability and better governance in its neighbourhood 16 countries in direct EU neighbourhood Algeria, Armenia, Azerbaijan, Belarus, Egypt, Georgia, Israel, Jordan, Lebanon, Libya, Moldova, Morocco, Occupied Palestinian Territory, Syria, Tunisia, Ukraine EFSA & ENP countries

8. 8 Committed since 2002 to ensuring that Europe’s food is safe EFSA & ENP countries Cooperation 2009 - 2010 via TAIEX funded workshops 2009 Seminar on the Food Safety and the role of the EFSA – 1/2 July in Brussels First meeting of the EU food safety bodies with the ENP countries Jointly organised by EFSA, DG SANCO, DG Relex and TAIEX the starting point for a new cooperation between the EU and ENP-countries in the area of food safety 2010 2 regional seminars on Handling Food Emergencies/Crises in the Food Chain: one took place in Kiev 28/29 April for the 6 Eastern Partnership countries one in Parma 23/24 October for the 10 Mediterranean countries

9. 9 Committed since 2002 to ensuring that Europe’s food is safe EFSA & ENP countries Cooperation 2009 - 2010 via TAIEX funded workshops 2011: TAIEX funded seminar on Animal Health incl. regional policies to support trade for the Mediterranean countries in Brussels, 8/9 September 2011 2012 – 2014: Probably a Multi-country Programme for the ENP Countries following the best practices of the Pre-Accession Programme: 1. Training seminars 2. Study tours to the EU Member States 3. Participation in EFSA scientific colloquiums and conferences for more information http://www.efsa.europa.eu/en/networks/euenlargement.htmhttp://www.efsa.europa.eu/en/networks/euenlargement.htm

10. 10 Committed since 2002 to ensuring that Europe’s food is safe Today’s talk will cover EFSA remit & organization Risk assessment of GMOs at EFSA EFSA procedure for GMO applications

11. 11 GMO Regulation in EU In the EU, products that are, contain, or are produced from GMOs must have an authorisation prior to entering the market. Committed since 2002 to ensuring that Europe’s food is safe

12. 12 Committed since 2002 to ensuring that Europe’s food is safe ‘Genetically modified organism (GMO)’ means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. Dir. 2001/18/EC: GMO definition Source: Article 2 of European Union Directive 2001/18/EC

13. 13 Committed since 2002 to ensuring that Europe’s food is safe EU Legislations on GMOs Directive 2001/18/EC (Deliberate release into the environment of GMOs) Regulation (EC) No 1829/2003 (Genetically modified food and feed) Regulation (EC) No 1830/2003 (Traceability and labelling of GMOs) Regulation (EC) No 1946/2003 (Transboundary movement of GMOs) Regulation (EC) No 65/2004 (Unique Identifiers for GMOs) Decision 2004/204/EC (Registers recording information on GMOs) Regulation (EC) No 641/2004 (Implementation of Regulation (EC) No 1829/2003) Regulation (EC) No 882/2004 (Official controls for feed and food law) Recommendation 2004/787/EC (Guidance for sampling and detection of GMOs) Regulation (EC) No 1981/2006 (Implementation of Article 32 of Regulation (EC) No 1829/2003) Commission Recommendation 2010/C200/01 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops …. Source: JRC57223 report, doi:10.2788/71623, also available at http://europa.eu/

14. 14 Committed since 2002 to ensuring that Europe’s food is safe Key objective:  to protect human and animal health by introducing at EU level a safety assessment of the highest possible standards, before any GM food and feed is placed on the market.  to have in place harmonised procedures for risk assessment and authorisation of GM food and feed that are efficient, time-limited and transparent.  to ensure clear labelling of GM food and feed in order to respond to consumers' concerns and enable them to make an informed choice. EU Legislations on GMOs Source: Regulation (EC) No 1829/2003

15. 15 Committed since 2002 to ensuring that Europe’s food is safe Legal Instruments for GMO RA at EFSA Directive 2001/18/EC (Deliberate release into the environment of GMOs) Regulation (EC) No 1829/2003 (Genetically modified food and feed) Regulation (EC) No 1830/2003 (Traceability and labelling of GMOs) Regulation (EC) No 1946/2003 (Transboundary movement of GMOs) Regulation (EC) No 65/2004 (Unique Identifiers for GMOs) Decision 2004/204/EC (Registers recording information on GMOs) Regulation (EC) No 641/2004 (Implementation of Regulation (EC) No 1829/2003) Regulation (EC) No 882/2004 (Official controls for feed and food law) Recommendation 2004/787/EC (Guidance for sampling and detection of GMOs) Regulation (EC) No 1981/2006 (Implementation of Article 32 of Regulation (EC) No 1829/2003) Commission Recommendation 2010/C200/01 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops …. Source: JRC57223 report, doi:10.2788/71623, also available at http://europa.eu/

16. 16 Committed since 2002 to ensuring that Europe’s food is safe GMO RA by EFSA GMO Panel & GMO Unit 21 external scientists in their private capacity 5 standing + several temporary WGs 14 scientists + 7 secretaries

17. 17 Committed since 2002 to ensuring that Europe’s food is safe Expertises range for GMO RA at EFSA Molecular characterisation biochemistry molecular biology genetics plant breeding food and environmental microbiology soil microbiology Food feed safety toxicology immunology biotechnology food chemistry nutrition & animal feed Environmental risk assessment ecology plant biology agronomy entomology biometrics statistics Working groups with Ad-hoc experts in novel techniques, law Working Groups with Ad-hoc experts in pesticides, natural toxins, environmental monitoring Working groups with Ad-hoc experts in food sciences, animal pathology 21 GMO Panel Members 21 EFSA staff 50 ad hoc specialist experts 210 MS experts representing 108 organisations and authorities from all EU member states

18. 18 Committed since 2002 to ensuring that Europe’s food is safe 1. Risk assessment activities:  Scientific evaluation of GMO applications for market release within the EU regulatory framework  Development of GMO related guidance documents for applicants  In-depth analysis of scientific issues related to risk assessment in self-tasking activities (= internal mandates) and special mandates from the EU commission (e.g. assessment of post market environmental monitoring reports from applicants & national safeguard clauses) EFSA GMO Panel & Unit All output documents can be found at Register of Questions - http://registerofquestions.efsa.europa.eu http://registerofquestions.efsa.europa.eu

19. 19 Committed since 2002 to ensuring that Europe’s food is safe 2. Risk communication activities: EFSA GMO Panel & Unit Risk Managers (EC, EP, MS) Stakeholders (Environment, Consumer,Health NGOs, Industry) Media (Food, Health, EU Affairs) Stakeholders (Scientists/ Academics) Policy Makers (EU & beyond) Risk Assessors (e.g. MS) Concerned Individuals

20. 20 Committed since 2002 to ensuring that Europe’s food is safe EFSA Guidance Documents on GMO Plants PLANTS Guidance for risk assessment of food and feed from GM plants (2011) Environmental Risk Assessment (ERA) of GM Plants (2010) Supporting documents Application submission guidance (2012) Selection of comparators for the risk assessment of GM plants (2011) Statistical considerations (2009) Use of animal feeding trials for safety assessment of whole GM food/feed (2008) Scientific Committee 90-day study on whole food/feed in rodents (2011) Allergenicity assessment of GM plants and microorganisms (2010) Post market environmental monitoring – PMEM (2011) Potential impacts on non-target organisms (2010) Guidance for non-food/non-feed use of GM plants (2009)

21. 21 Committed since 2002 to ensuring that Europe’s food is safe EFSA Guidance for GM plants for authorisation of genetically modified food and feed and genetically modified plants for food and feed uses under Regulation (EC) No 1829/2003 ERA Guidance http://www.efsa.europa.eu/en/efsajournal/doc/ 1879.pdf Food/Feed Guidance http://www.efsa.europa.eu/en/scdocs/scdoc/ 293r.htm Application Submission Guidance http://www.efsa.europa.eu/en/efsajournal/pub/2311.htm Tomorrow Today

22. 22 Committed since 2002 to ensuring that Europe’s food is safe EFSA Guidance Documents on other GMOs MICROORGANISMS GM microorganisms and their food and feed products (2011) ANIMALS Guidance for risk assessment of food and feed from GM animals including animal health and welfare aspects (2012) Environmental risk assessment of GM animals currently under development  GMO guidance are living documents

23. 23 Committed since 2002 to ensuring that Europe’s food is safe EFSA Guidance Documents on GMOs European Commission Legislation FAO/WHO: CODEX alimentarius OECD: Organisation for Economic Co- operation and Development Biosafety Research (e.g. ENTRANSFOOD EU Network on Safety Assessment of GM Food Crops etc. JRC, EMA, ECDC, EEA All guidance takes into account

24. 24 Committed since 2002 to ensuring that Europe’s food is safe Today’s talk will cover EFSA remit & organization Risk assessment of GMOs at EFSA EFSA procedure for GMO applications

25. 25 Committed since 2002 to ensuring that Europe’s food is safe 25 Reg. 1829/2003: One key one door concept EFSA guidance documents for GM plants Update Food/Feed Guidance, http://www.efsa.europa.eu/en/scdocs/scdoc/293r.htm http://www.efsa.europa.eu/en/scdocs/scdoc/293r.htm Update of the ERA Guidance, http://www.efsa.europa.eu/en/efsajournal/doc/1879.pdf http://www.efsa.europa.eu/en/efsajournal/doc/1879.pdf Application submission guidance, http://www.efsa.europa.eu/en/efsajournal/pub/2311.htm http://www.efsa.europa.eu/en/efsajournal/pub/2311.htm Notifications under Directive 2001/18/EC Applications under Regulation (EC) 1829/2003 Scope of an applications Food GMO for food use Food containing or consisting of GMOs Food produced from or containing ingredients produced from GMO Feed GMO for feed use Feed containing or consisting of GMOs Feed produced from GMOs Deliberate release into the environment Import and processing Seeds and plant propagation material for cultivation GM Plants food/feed use (1829/2003/EC) GM Plants release into environment (2001/18/EC) Yearsubmittedadoptedsubmittedadopted 2003 - 2006 36 91311 200738 5 1- 200813 5 -1 200913 18 1- 20101410 -1 2011137 -- 201253 --

26. 26 Committed since 2002 to ensuring that Europe’s food is safe Overview of GM Plants Applications Total: 120 An authorisation for commercial release is valid for 10 years. Renewal is possible.

27. 27 Committed since 2002 to ensuring that Europe’s food is safe GM plants under Regulation (EC) No 1829/2003 Application Process at EFSA Completeness Check by EFSA staff WG food feed WG environment WG molecular characterisation GMO Panel Opinion Overall opinion & Communication Step 1-5: CC check Step 6-11: risk assessment Step 12: communication

28. 28 Committed since 2002 to ensuring that Europe’s food is safe EFSA Application Submission Guidance Application process

29. 29 Committed since 2002 to ensuring that Europe’s food is safe Reg. 1829/2003: Legal Deadlines - A national competent authority shall acknowledge receipt of the application in writing to the applicant within 14 days of its receipt, and shall inform EFSA without delay - EFSA shall without delay inform other MS and EC, shall make information available, shall publish the summary - EFSA overall opinion = within 6 months after receipt of a valid application - Member States consultation = 3 months - Within three months after receiving the EFSA opinion EC shall submit to the committee a draft decision

30. 30 Committed since 2002 to ensuring that Europe’s food is safe Stop the clock provision only foreseen to request and assess additional information from applicant (EFSA or CRL) Reg. 1829/2003: Clock mechanism ” EFSA shall endeavour to respect a time limit of six months as from the receipt of a valid application. Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant….” No provision to take into account the spontaneous submission of information from applicants.

31. 31 Committed since 2002 to ensuring that Europe’s food is safe EFSA Application Submission Guidance Application Submission Guidance One main text supplemented with 9 appendices Main text: 1. Application procedure 2. Application preparation 3. Specifics on different parts 4. Stacked events 5. Renewal applications 6. Previous submission under another legislation Appendices: A.Contact details B.Completeness checklist C.Exemplar figures and tables for Part II D.Schematic summary of data for field or greenhouse trial for agronomic and phenotypic characteristics within a season (GM plants containing single or stacked event(s)) E.Schematic summary of information for Insect Resistance Management F.Schematic summary of NTO studies G.Schematic summary of statistical design and analysis for each ERA related study H.Statement of sample submission to EURL-GMFF I.Summary of applications

32. 32 Committed since 2002 to ensuring that Europe’s food is safe EFSA Application Submission Guidance Structure of an application

33. 33 Committed since 2002 to ensuring that Europe’s food is safe EFSA Application Submission Guidance How many versions of application? When submitting to a Member State Competent Authority: 1 electronic copy + 1 paper copy  version CC1 During completeness check by EFSA: 1 electronic copy when responding to EFSA questions, an updated version of the entire application (Parts I to VIII), accompanied by a cover letter precisely describing how each EFSA question was addressed for example:response 1  version CC2 response 2  version CC3 After validity EFSA may request additional electronic and paper copies.

34. 34 Committed since 2002 to ensuring that Europe’s food is safe EFSA Application Submission Guidance Confidential and non-confidential Submission version: Option 1: 2 CDs (1 for CI + 1 for non-CI) Option 2: 1 CD (CI and non-CI together) Public access version: 1 CD: only non-CI Folder name in a CD: Option 1: Appendices (CI) and Appendices (non-CI) Option 2: Appendices (CI and non-CI) File name:  Sections or studies considered as confidential should be identified by including CI in brackets in the file name, e.g. “Appendix x (CI).pdf” and “CONFIDENTIAL” on the corresponding pages.  If the author’s names are claimed as confidential, they should not be included in the file name and citation

35. 35 Committed since 2002 to ensuring that Europe’s food is safe Risk Assessment (science based) EFSA Risk Assessment (science based) EFSA Risk Management (Policy based) EC and Member States Risk Communication (interactive exchange info and opinion concerning risks) EFSA Summary 1 - EFSA Risk analysis Source: adapted from WHO/FAO 1997

36. 36 Committed since 2002 to ensuring that Europe’s food is safe Summary 2 - Community procedure Risk Assessment Risk Management European Commission Consultation with all Member States (all applications) Public consultation One MS performs initial environmental risk assessment (cultivation dossier only) MS: Decision to authorize or not to authorize GMO application (via MS) forwarded to EFSA Scientific Opinion Member States have access to all GMO applications and provide input through “EFSAnet”.

37. 37 Committed since 2002 to ensuring that Europe’s food is safe Any questions, use Ask EFSA service available at http://www.efsa.europa.eu/en/contact/askefsa.htmhttp://www.efsa.europa.eu/en/contact/askefsa.htm How to submit an application, consult Application helpdesk available at http://www.efsa.europa.eu/en/applicationshelpdesk.htm http://www.efsa.europa.eu/en/applicationshelpdesk.htm Correspondence concerning a specific GMO application, email GMO_secretariat_applications@efsa.europa.eu

38. 38 Yi Liu EFSA GMO Unit yi.liu@efsa.europa.eu Thank you for your attention!