Presenting EFSA by Catherine Geslain-Lan

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Presenting EFSA byCatherine Geslain-Lanéelle,
Executive DirectorandRiitta 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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EFSAs guiding principles
Core values

• Scientific excellence
• Independence
• Openness
• Transparency
• Responsiveness

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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
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EFSA advises on food/feed safety across the
entire food chain
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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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10 Scientific Panels and Scientific Committee

• Animal health and welfare
• Food additives and nutrient sources
• Biological hazards
• Food contact materials, enzymes, flavourings
• Contaminants

• Feed additives
• Genetically modified organisms
• Nutrition
• Plant health
• Plant protection products

Scientific Committee
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(No Transcript)
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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. EFSAs 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• Draft guidance documents were adopted and are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

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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 1st June 2010 Stakeholder Meeting
• open registration on EFSAs website

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Risk Assessment - Bisphenol A (BPA)

• 2007-2008 Existing EFSAs 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 Objectives

• Focus on providing an integrated approach to
  delivering scientific advice associated with the
  food chain from field to plate
• Provide timely, high-quality evaluation of
  products, substances and claims subject to the
  regulatory authorisation process
• Coordinate the collation, dissemination and
  analysis of data in the fields within EFSAs
  remit
• Position EFSA at the forefront of risk assessment
  methodologies and practices in Europe and
  Internationally
• Reinforce confidence and trust in EFSA and the EU
  food safety system through effective risk
  communication and dialogue with partners and
  stakeholders
• Assure the responsiveness, efficiency and
  effectiveness of EFSA

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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 EFSAs scientific
  advice
• INEX in place
• DoI policy fully implemented
• Implementing the Strategy for Cooperation and
  Networking
• Contracts and grants 5.6 m (2008) ? 6.8 m
  (2009)
• Strengthening EFSAs capacity to identify
  emerging risks
• Implementing EFSAs 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

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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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EFSAs outputs
Massive/increasing number of applications Mostly
unpredictable/complex regulatory workflows
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Challenges 2010-2011evolving 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

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Key priorities for 2010

• Boost risk assessment capacity in Europe
• Promote the use of the integrated approach for
  scientific advice
• Strengthen the effectiveness of EFSAs
  communications
• Implement the Strategic Approach to International
  Activities
• Consolidate EFSAs attractiveness for staff and
  scientific experts