Scientific Evaluation and Innovation

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• Scientific Evaluation and Innovation
• in Risk Assessment approaches in the area of Food
  Safety
• Promoting the leadership of agro-food industry
• Conference organised by the European Commission,
  15-16 November, Brussels

Djien Liem Scientific Committee Advisory Forum
Unit
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Content of my presentation

• EFSA Where are we in 2007
• Mandate
• Organisation, Partners and Networks
• Achievements
• Focus on Innovation in RA
• Opportunities and future challenges

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What EFSA does
EFSAs tasks

• Provide scientific advice, opinions, information,
  and technical support for Community legislation
  and policies
• Collect and analyse data to allow
  characterisation and monitoring of risks
• Promote and coordinate development of uniform
  risk assessment methodologies
• 4. Communicate risks related to all aspects of
  EFSAs mandate

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What EFSA does
What EFSA cannot do

• Be responsible for food safety legislation
• Take charge of food safety/quality controls,
  labelling or other such issues
• Act as a substitute for national authorities

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EFSA timeline
Timeline

2002 Legal establishment (January) 1st meeting
of Management Board (September)
2003 Council decision establishes Parma as
EFSAs official seat (Dec) Scientific Committee
and Panels begin work (May) 1st meeting of
Advisory Forum (March)
2004 Launch of EFSA website (March)
2005 Inauguration of EFSAs official seat in
Parma (June)
2006 Renewal of Management Board, Scientific
Committee and Panels (June) Catherine
Geslain-Lanéelle, Executive Director of EFSA
(July) Over 200 support staff by
end of 2006
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EFSA timeline
EFSA today

• Where are we in 2007?
• Based in Parma, Italy
• Over 190 scientific experts (SC and Panels)
• Over 450 scientific opinions
• Over 140 press releases/statements
• EFSA Stakeholder Consultative Platform fully
  established
• 10 Scientific Colloquia on key topics
• Budget 51.6 million for 2007

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EFSA structure
Management Board
Advisory Forum
Scientific Committee and Panels
EFSA Directorate and Staff
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Management Board
Role

• Primary role ensure Authority functions
  effectively and efficiently
• Establish budget, agree work programmes and
  monitor implementation
• Ensure Authority stays within remit of Founding
  Regulation
• Appoint Executive Director, Scientific Committee
  and Panels
• Audit Authoritys operations

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Management Board
Six Priorities June 2006 recommendations

• Develop active networking and stronger
  co-operation with Member States
• Strengthen EFSAs relationship with its
  institutional partners (EU and international) and
  stakeholders
• Enhance EFSAs organisation
• Enhance the impact and effectiveness of EFSAs
  communications
• Develop EFSAs role in nutrition
• Define EFSAs medium and long-term vision

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Advisory Forum
Role

• Advise EFSA on scientific matters, work
  programme/priorities and emerging risks
• Ensure close collaboration between national
  bodies and EFSA
• Assist in resolving contentious scientific issues
  and avoiding divergent views on food/feed safety
  issues
• Avoid duplication of scientific effort
• Play a key role in sharing and disseminating
  information (Declaration of Intent, Sep 2006)
• Assist in increasing scientific co-operation
  between Member States (Strategy for Cooperation
  Networking, Dec 2006)

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EFSA Staff
Overall profile

• 277 staff on 1 Sep 2007
• Expected to reach 300 by end of 2007
• Genuinely multinational and multicultural
• Temporary agents (236), contract agents (22),
  national experts (9)

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Breakdown by nationality
EFSA Staff
January 2007
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EFSA Staff
Structure

• 3 Directorates
• Science
• Communications
• Administration
• Science Directorate has 2 departments
• Risk Assessment Scientific Panels
• Scientific Co-operation and Assistance

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Science Directorate

• Department of Scientific Cooperation and
  Assistance (SCA)
• comprising
• Data collection and exposure (DATEX) Unit
• Scientific cooperation (SCOOP) Unit
• Emerging risks (EMRISK) Unit
• Assessment methodology (ASMET) Unit
• Pesticides risk assessment (PRAPeR) Unit
• Zoonosis Unit.

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Scientific Committee and Panels
Science

• Nine Scientific Panels
• First established June 2003 - re-established June
  2006
• New Panel on Plant Heath created June 2006
• Independent scientists selected on basis of
  proven excellence in their field
• Mandatory commitment of independence
• Declaration of Interest (annual and per meeting)
• Split of AFC Panel into two Panels in
  preparation

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The 9 Scientific Panels

• Food additives, flavourings, processing aids,
  materials in contact with food (AFC)
• Animal Health and Welfare (AHAW)
• Biological hazards (BIOHAZ)
• Contaminants in the food chain (CONTAM)
• Additives and products in animal feed (FEEDAP)
• Plant Protection Products (PPR)
• Genetically modified organisms (GMO)
• Dietetic products, nutrition and allergies (NDA)
• Plant Health Panel (PLH)

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Scientific Committee

• Comprises the Chairs of all 9 Panels
• Additional 6 independent members
• Provides guidance to all Panels
• Manages projects involving several Panels
• Advises EFSA on emerging issues and priorities
  for scientific work.

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Scientific activities (work themes)

• General Requests for Scientific Opinions and
  Advice providing scientific opinions, guidance
  and advice in response to questions
• Authorisations Assessing the risk of regulated
  substances and development of proposals for
  risk-related factors
• Monitoring and assessing specific biological risk
  factors for human animal health and animal
  diseases BSE/TSE, Zoonoses, plant health
• Improving the European risk assessment approaches
  and methodologies Development, promotion and
  application of new and harmonized scientific
  approaches and methodologies for hazard and risk
  assessment

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Harmonisation/Innovation 2003-2007

• Guidance on RA approaches to be used by EFSAs
  Panels and Expert working groups
• Guidance documents on RA approaches in the area
  of GMOs, Animal Nutrition, Plant Protection
  Products
• Harmonised methods for Exposure Assessment (e.g.
  how to organise EA in EFSA, handling new trends
  and developments, advice on how to access
  relevant data, uncertainties and variability)
• Harmonised approach for RA of substances that are
  both Genotoxic and Carcinogenic
• Qualified Presumption of Safety a generic
  approach for the safety assessment of
  microorganisms in food/feed

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New and harmonised RA Ongoing and planned
activities

• AMONG OTHERS
• Transparency in RA Part 2 Science-related
  aspects
• Welfare of experimental animals
• Benchmark Dose Approach
• Botanicals and botanical preparations
• Qualified Presumption of Safety
• Risk-Benefit assessments
• RA of application of nanoscience and -technology
  in food/feed

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New and harmonised RA Ongoing and planned
activities

• AMONG OTHERS (contd)
• Applicability of the TTC concept in EFSAs risk
  assessments
• Follow-up of SCs opinions on genotoxic
  carcinogens and exposure assessment
• Quantitative Microbiological RA
• and
• Various scientific cooperation projects

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Science
Origin of requests for 2006
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Scientific Activity 2006
Science
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Scientific Activity 2006
Science
Total number of scientific outputs 174
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Science
Scientific Colloquia

• Dioxins June 2004, Brussels
• Qualified Presumption of Safety December 2005,
  Brussels
• Food Consumption April 2005, Brussels
• Animal Welfare December 2005, Parma
• Food-based Dietary guidelines March 2006, Parma
• Risk-Benefit Analysis of Foods July 2006,
  Tabiano
• Pesticides Cumulative Risk Assessment November
  2006, Parma
• Environmental RA of GM Plants June 2007,Tabiano
• Nutrient Profiling and Health Claims October
  2007, Parma
• RA in Plant Health December 2007, Parma

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Looking to the future

Vision

• My vision is for EFSA to become 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 
• Catherine Geslain-Lanéelle, Executive Director of
  EFSA

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Looking to the future
Future challenges and perspectives

• Handling the Workload (prioritisation)
• Credibility of scientific advice
• New areas of work
• Nanotechnology
• Animal cloning
• Claims
• Scientific co-operation with Member States (focal
  points)
• International relations strategy
• Expand and consolidate EFSA organisation

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Priority areas for scientific cooperation (EFSA,
2006)

• Exchanging and collecting scientific data and
  information
• Sharing best risk assessment practices
• Developing harmonized methodologies for risk
  assessment
• Promoting coherence in risk communications

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Scientific cooperation projects (Nov 2007)

• Establishing a European network of managers of
  chemical occurrence data
• Establishing a European network of food
  consumption database managers
• Risks and benefit of the fortification of food
  with folic acid
• Horizon scanning to identify emerging food safety
  risks
• Setting-up a database of national experts in
  Europe
• Botanicals and botanical preparations
• Harmonisation of risk assessment approaches in
  Member States

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Looking to the future (Contd)
Future challenges and perspectives

• Data collection (chemical and biological hazards,
  dietary exposure, consumer choice)
• Harmonising methodologies for RA across Europe
• Building (together) a system for identification
  and evaluation of emerging risks
• Implementing preparedness tools for
  predictable/unpredictable events
• Governance/Confidence/Changing society/Globalisati
  on (key challenges SANCO 2009-2014)

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Thanks for your kind attention !!