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EFSA general priorities
                                         Per Bergman

                                     Director of
         Scientific Evaluation of Regulated Products Directorate (REPRO)


ECPA-IBMA workshop with EFSA on evaluation on PPP
Committed since 2002
                                                                           1
to ensuring that Europe’s food is safe
About EFSA
    EFSA gives advice from farm to fork
 Plant Health      Plant Protection
                                           Genetically modified
                                              organisms


                          Animal health
     Biological                               Animal feed
                         and welfare and
       food               their diseases
   chain hazards


                          Food additives
                                                Dietary,
   Food chain            Flavourings and
                                             nutritional and
  contaminants            Procesing aids
                                               novel food


                     2                                            2
                     2             Food packaging
What EFSA does

          Who can task EFSA?



  European Commission    EU Member States




   European Parliament      Self-tasking


                                            3
EFSA’s guiding principles


           Core values
           •   Scientific excellence
           •   Independence
           •   Openness
           •   Transparency
           •   Responsiveness


                                       4
Organisation
Organisation
REPRO – Application areas

Main food and feed regulatory areas where REPRO     Responsible unit
is currently called to review applications          (REPRO Directorate)
Food additives
Nutrient sources
Flavourings                                         FIP
Enzymes
Food contact material
Feed additives                                      FEED
Genetically Modified Organisms (GMO)                GMO
Health claims
Novel food
                                                    NUTRITION
Infant formulae
Food allergies
Plant Protection Products: active substances (PPP) and
                                                       PESTICIDES
Maximum Residual Levels (MRL)
                                                                          7
About REPRO

• REgulated         • Assess, advise, communicate

• PROducts          • Independent, based on sound science


                      Mandate
 Provide scientific advice and support for EU legislation,
   policies in fields that impact food and feed safety

 Provide independent information on all relevant matters

 Communicate the risks
                                                             8
Scientific outputs

A.1. Opinions of Scientific Committee
   (SC)/Scientific Panel (SP)
                                        A.2 Other EFSA scientific outputs
   A.1.1 Opinion of the SC/SP
                                        A.2.1 Statement of EFSA
   A.1.2 Statement of the SC/SP
                                        A.2.2 Guidance of EFSA
   A.1.3 Guidance of the SC/SP
                                        A.2.3 Conclusion on Pesticides Peer Review

                                        A.2.4 Reasoned Opinion

                                        A.2.5 Scientific Report of EFSA
   B. Supporting publications
       B.1 Technical Report
       B.2 External Scientific Report

       B.3 Event Report

                                                                                 9
Publication of scientific outputs




                                                                     10
         http://www.efsa.europa.eu/en/publications/efsajournal.htm
Working together
             Cooperation with:
• 30 national food safety agencies
• 300 research institutes
• Over 1500 experts




                         • EU Agencies
                         • 3rd country organisations
                                                       11
EFSA Outputs: Examination of
authorisation dossiers

   Outputs related to applications vs. total outputs




                                                       12
Current applications workload

  Steadily increasing applications in number and complexity
     •   Since 2003 number of applications almost doubled
     •   900 new dossiers in 2010 - of which 450 on health claims

  Applications typically come in bulk within large product
    reviews (PPP, food and feed additives, health claims, etc.)

  More than 40% of EFSA budget spent on applications in 2011

  The work in this area comprises 60-70% of the overall
    EFSA´s scientific outputs

  Very complex legal environment evolving over time


                                                                    13
2013 priorities
• Continuing high demand for scientific advice: 676
  scientific outputs predicted

• Further boost risk assessment capacity: full
  implementation of EFSA Science Strategy 2012-2016; enhanced
  knowledge management programme; support for managing scientific
  literature; structured scientific data

• Dialogue with risk managers: multi-annuality
• Review of planning in scientific cooperation: efficiency
  of contracts & grants programme (€10.6 million); strategic and
  multiannual approach; workshops with stakeholders

• Continue enhancing EFSA’s efficiency: business process
  mapping
• EU economic/budgetary context and EU multi-annual
  financial framework 2014-2020
                                                                    14
Other priorities in 2013

• New services delivered by EFSA’s Application
  Helpdesk: interactions with SMEs, streamline of application
  procedures

• Electronic submission of applications: feasibility study
  and benchmarking with other EU agencies

• Human capital development: training for Panel members and
  EFSA staff, enhanced knowledge management programme

• Integrated quality management system: scientific outputs
  covered by December 2013




                                                                15
2013 science highlights (I)
  Public health
  – Meat inspection: scientific basis for the modernisation of meat
    inspection in EU, multidisciplinary

  – Dietary reference values for micronutrients
  – Plant toxicants
  – Mycotoxins

  – TSEs
  – Metals, mercury in fish
  – Perfluoro compounds

  – Animal-based welfare indicators
  Risk ranking: multiagency project, prioritisation of requests for work
  Crisis preparedness: annual training and simulation exercises organised
     with Member States                                                  16
2013 science highlights (II)
  Application-related
   – GMOs: cultivation and post-market environmental monitoring,
     guidance document on risk assessment of GM animals
   – Health claims: Article 13.5 and Article 14/reevaluation of some
     Article 13 claims
   – Pesticides: new active substances, renewals of approval,
     cumulative risk assessment
   – Plastic food contact materials
   – Recycled materials
   – Process aids
   – Flavourings, enzymes
   – Novel foods
                                                                       17

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Per Bergman - EFSA general priorities

  • 1. EFSA general priorities Per Bergman Director of Scientific Evaluation of Regulated Products Directorate (REPRO) ECPA-IBMA workshop with EFSA on evaluation on PPP Committed since 2002 1 to ensuring that Europe’s food is safe
  • 2. About EFSA EFSA gives advice from farm to fork Plant Health Plant Protection Genetically modified organisms Animal health Biological Animal feed and welfare and food their diseases chain hazards Food additives Dietary, Food chain Flavourings and nutritional and contaminants Procesing aids novel food 2 2 2 Food packaging
  • 3. What EFSA does Who can task EFSA? European Commission EU Member States European Parliament Self-tasking 3
  • 4. EFSA’s guiding principles Core values • Scientific excellence • Independence • Openness • Transparency • Responsiveness 4
  • 7. REPRO – Application areas Main food and feed regulatory areas where REPRO Responsible unit is currently called to review applications (REPRO Directorate) Food additives Nutrient sources Flavourings FIP Enzymes Food contact material Feed additives FEED Genetically Modified Organisms (GMO) GMO Health claims Novel food NUTRITION Infant formulae Food allergies Plant Protection Products: active substances (PPP) and PESTICIDES Maximum Residual Levels (MRL) 7
  • 8. About REPRO • REgulated • Assess, advise, communicate • PROducts • Independent, based on sound science Mandate Provide scientific advice and support for EU legislation, policies in fields that impact food and feed safety Provide independent information on all relevant matters Communicate the risks 8
  • 9. Scientific outputs A.1. Opinions of Scientific Committee (SC)/Scientific Panel (SP) A.2 Other EFSA scientific outputs A.1.1 Opinion of the SC/SP A.2.1 Statement of EFSA A.1.2 Statement of the SC/SP A.2.2 Guidance of EFSA A.1.3 Guidance of the SC/SP A.2.3 Conclusion on Pesticides Peer Review A.2.4 Reasoned Opinion A.2.5 Scientific Report of EFSA B. Supporting publications B.1 Technical Report B.2 External Scientific Report B.3 Event Report 9
  • 10. Publication of scientific outputs 10 http://www.efsa.europa.eu/en/publications/efsajournal.htm
  • 11. Working together Cooperation with: • 30 national food safety agencies • 300 research institutes • Over 1500 experts • EU Agencies • 3rd country organisations 11
  • 12. EFSA Outputs: Examination of authorisation dossiers Outputs related to applications vs. total outputs 12
  • 13. Current applications workload Steadily increasing applications in number and complexity • Since 2003 number of applications almost doubled • 900 new dossiers in 2010 - of which 450 on health claims Applications typically come in bulk within large product reviews (PPP, food and feed additives, health claims, etc.) More than 40% of EFSA budget spent on applications in 2011 The work in this area comprises 60-70% of the overall EFSA´s scientific outputs Very complex legal environment evolving over time 13
  • 14. 2013 priorities • Continuing high demand for scientific advice: 676 scientific outputs predicted • Further boost risk assessment capacity: full implementation of EFSA Science Strategy 2012-2016; enhanced knowledge management programme; support for managing scientific literature; structured scientific data • Dialogue with risk managers: multi-annuality • Review of planning in scientific cooperation: efficiency of contracts & grants programme (€10.6 million); strategic and multiannual approach; workshops with stakeholders • Continue enhancing EFSA’s efficiency: business process mapping • EU economic/budgetary context and EU multi-annual financial framework 2014-2020 14
  • 15. Other priorities in 2013 • New services delivered by EFSA’s Application Helpdesk: interactions with SMEs, streamline of application procedures • Electronic submission of applications: feasibility study and benchmarking with other EU agencies • Human capital development: training for Panel members and EFSA staff, enhanced knowledge management programme • Integrated quality management system: scientific outputs covered by December 2013 15
  • 16. 2013 science highlights (I) Public health – Meat inspection: scientific basis for the modernisation of meat inspection in EU, multidisciplinary – Dietary reference values for micronutrients – Plant toxicants – Mycotoxins – TSEs – Metals, mercury in fish – Perfluoro compounds – Animal-based welfare indicators Risk ranking: multiagency project, prioritisation of requests for work Crisis preparedness: annual training and simulation exercises organised with Member States 16
  • 17. 2013 science highlights (II) Application-related – GMOs: cultivation and post-market environmental monitoring, guidance document on risk assessment of GM animals – Health claims: Article 13.5 and Article 14/reevaluation of some Article 13 claims – Pesticides: new active substances, renewals of approval, cumulative risk assessment – Plastic food contact materials – Recycled materials – Process aids – Flavourings, enzymes – Novel foods 17