Presenting EFSA by Catherine Geslain-Lanéelle Executive Director and

Presenting EFSA by Catherine Geslain-Lanéelle, Executive Director and Riitta Maijala, Director of Risk Assessment 1

EFSA at a Glance European The European Reference Body Food Covers the entire food chain Safety Assess, advise, communicate Authority Independent, trusted, based on sound science 2

EFSA’s guiding principles Core values • • • Scientific excellence Independence Openness Transparency Responsiveness 3

Mission and vision EFSA mission: • Provide scientific advice and support for EU law/policies on food and feed safety • Provide independent information • Communicate the risks EFSA vision: It is to become by 2013 globally recognised as the European reference body for risk assessment on food and feed safety, animal health and welfare, nutrition, plant protection and plant health 4

EFSA advises on food/feed safety across the entire food chain 5

Who can task EFSA European Commission EU Member States European Parliament Self-tasking

EFSA structure Management Board + EFSA Staff + Advisory Forum + Scientific Committee and Panels = 7

10 Scientific Panels and Scientific Committee 1. Animal health and welfare 6. Feed additives 2. Food additives and nutrient sources 7. Genetically modified organisms 8. Nutrition 3. Biological hazards 9. Plant health 4. Food contact materials, enzymes, flavourings 5. Contaminants 10. Plant protection products + Scientific Committee 8

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Risk Assessment - GMOs EFSA does not authorise GMOs, which is done by the European Commission and Member States in their role as risk managers. EFSA’s role is strictly limited to giving scientific advice In 2009 : • 17 scientific Opinions covering 21 application dossiers were adopted • 12 technical reports connected to application dossiers (“overall opinions”), which in addition to the scientific opinion also contain Member State comments and other documents stipulated in the regulation. In 2010 : • Draft guidance documents were adopted and are open for public consultation regarding environmental risk assessment of GM plants 10

Risk Assessment - Health Claims List of Art. 13. 1 – health claims: • • July-December 2008: 4, 185 claims submitted by EC to EFSA Jan 2009: EFSA sent back approx. 2, 000 claims for clarification Nov 2009 – March 2010: feedback from EC/MSs Current situation: 4, 637 claims received in total 993 claims evaluated 937 claims published (Oct 09/Feb 10) 297 claims withdrawn ∑ 3, 347 claims in progress Claims – applications (Art. 13. 5, Art 14) • Current situation: 299 aplications received 78 applications evaluated 43 withdrawn 19 in progress Parma – 1 st June 2010 – Stakeholder Meeting open registration on EFSA’s website 11

Risk Assessment - Bisphenol A (BPA) • 2007 -2008: Existing EFSA’s opinions on this food contact material • New studies emerged – EFSA evaluates these studies and invites MSs to subit studies/data • A meeting with MS was held on 26 March 2010 • A teleconference with international relevant organisations took place in March 2010. • Discussions are ongoing with WHO in view of the preparation of the Workshop on BPA in November 2010 in Canada • EFSA aims to complete its evaluation by May 2010, in line with the deadline set by the Commission 12

Strategic Plan 2009 – 2013 6 Strategic Objectives 1. Focus on providing an integrated approach to delivering scientific advice associated with the food chain from field to plate 2. Provide timely, high-quality evaluation of products, substances and claims subject to the regulatory authorisation process 3. Coordinate the collation, dissemination and analysis of data in the fields within EFSA’s remit 4. Position EFSA at the forefront of risk assessment methodologies and practices in Europe and Internationally 5. Reinforce confidence and trust in EFSA and the EU food safety system through effective risk communication and dialogue with partners and stakeholders 6. Assure the responsiveness, efficiency and effectiveness of EFSA 13

Main corporate achievements 2009 • Ensuring the effective delivery of timely, high-quality scientific advice Scientific outputs = 640 (+30% compared with 2008) Resources: Budget +7%, Staff +13% compared with 2008 Urgent advice (methylbenzophenone, nicotine) • Strengthening the quality of EFSA’s scientific advice INEX in place Do. I policy fully implemented • Implementing the Strategy for Cooperation and Networking Contracts and grants: € 5. 6 m (2008) → € 6. 8 m (2009) • • • Strengthening EFSA’s capacity to identify emerging risks Implementing EFSA’s Strategic Approach to International Activities Promoting coherence, simplicity and visibility in communication Target audience research • Ensuring a stimulating and rewarding working environment for both experts and staff EFSA Journal 14

Key factors in delivering EFSA work programme • Cooperation with MS: Art 36 + procurement (€ 6. 8 m in total), Advisory Forum, Focal Points • EFSA staff circa 450 • Networks: 1500 experts, 30 national agencies, 350 institutions • Dialogue with risk managers, DG SANCO bilaterals, Roadmap, Parliament, Presidencies • Efficiency gains: risk assessment workflow, review of authorisation processes etc. • Stakeholders: renewal of Platform, public consultations, technical meetings etc. 15

Operational context for 2010 High workload (similar to or greater than 2009): • delivery of 1000 scientific outputs Resources: • end of major growth phase for EFSA • budget 2010 (+2. 8%), staff 2010 (+2. 5%) • constraints in Member States Institutional framework: • • • new Commission Lisbon Treaty European Parliament external evaluation of EU agencies new members of Management Board 16

EFSA’s outputs 1400 Total Ouputs 1200 1000 800 Other applications 600 400 2003 2004 2005 2006 2007 2008 2009 Massive/increasing number of applications Mostly unpredictable/complex regulatory workflows 2010* 17

Challenges 2010 -2011: evolving tasks 1. Assessing safety and environmental impact of new products technologies e. g. novel foods, additives 2. Developing new risk assessment methodologies e. g. nanotechnology, active intelligent packaging e. g. omics, reduction of animal testing 3. Assess efficacy /benefit e. g. pesticides (2011), Claims Sustainable innovation = safe, environmentally friendly, backed by science → EU 2020 18

Key priorities for 2010 • Boost risk assessment capacity in Europe • Promote the use of the “integrated approach” for scientific advice • Strengthen the effectiveness of EFSA’s communications • Implement the Strategic Approach to International Activities • Consolidate EFSA’s attractiveness for staff and scientific experts 19