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Presenting EFSA by

Catherine Geslain-Lanéelle, Executive Directorand

Riitta Maijala, Director of Risk Assessment

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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

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EFSA’s guiding principles

• Scientific Scientific excellenceexcellence

• Independence Independence • Openness Openness • TransparencyTransparency• ResponsivenessResponsiveness

Core values

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EFSA mission:• Provide scientific advice and support for

EU law/policies on food and feed safety

• Provide independent information

• Communicate the risks

 

Mission and vision

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

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

Who can task EFSA

European Commission

European Parliament

EU Member States

Self-tasking

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EFSA structure

Management Board

Advisory Forum

Scientific Committee and Panels

EFSA Staff

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+ +

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10 Scientific Panels and Scientific Committee

1. Animal health and welfare

2. Food additives and nutrient sources

3. Biological hazards

4. Food contact materials, enzymes, flavourings

5. Contaminants

6. Feed additives

7. Genetically modified organisms

8. Nutrition

9. Plant health

10.Plant protection products

+Scientific Committee

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Risk Assessment - GMOs

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In 2010 : • Draft guidance documents were adopted and are open for public consultation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

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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

Risk Assessment - Health ClaimsList 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 total993 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 received78 applications evaluated43 withdrawn 19 in progress

Parma – 1st June 2010 – Stakeholder Meeting open registration on EFSA’s website

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Risk Assessment - Bisphenol A (BPA)

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• 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

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Strategic Plan 2009 – 20136 Strategic Objectives1. 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

Main corporate achievements 2009

• Ensuring the effective delivery of timely, high-quality scientific adviceScientific outputs = 640 (+30% compared with 2008)Resources: Budget +7%, Staff +13% compared with 2008Urgent advice (methylbenzophenone, nicotine)

• Strengthening the quality of EFSA’s scientific adviceINEX in placeDoI policy fully implemented

• Implementing the Strategy for Cooperation and NetworkingContracts 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 staffEFSA Journal

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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.

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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

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EFSA’s outputs

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Massive/increasing number of applicationsMostly unpredictable/complex regulatory workflows

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 packaginge.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

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Challenges 2010-2011:evolving tasks

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

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