1. Efficacy and other key challenges in the zonal system ECPA/ECCA Conference Brussels, March, 2014
Pavel Minář

2. Content
Efficacy challenges
Co-operation
Opportunities

3. Regulatory issues Prevailing duplications in expert areas Capacity
Iniciative and activity
Mutual recognition
National requirements

4. CZ Strategy Deadlines Solutions for minor uses
Pragmatic approach to data gaps
Restructuring
Strenghthening of inspection area

5. Biological Efficacy Minimum changes in criteria and data requirements
Most discussions connected with:
Definition of uses and pests
Number and location of trials
Dosage (minimum effective dose)
Levels of efficacy

6. Quality of dRR Efficacy part often inconsistent
Not all EPPO zones sufficiently covered
Different application rates
Some uses not sufficiently supported (different importance of crops)

7. Quality of dRR
Reference to studies submitted at the national level not available to ZRMS
Results of studies sometimes not corresponding with dRR tables
National labels not corresponding with the application
Different approaches within the same company

8. Commenting National requirements often applied
Different opinions within the same MS
Comments addressed but not summarised

9. Recommendations Harmonisation of risk mitigation measures necessary
Definition when data gap is acceptable (= risk mitigation measures)
Communication between experts

10. Recommendations Authorities to focus on effectiveness and priorities
Commenting to be limited to crucial issues, not on formal requirements
Compare effectiveness of experts and capacity in MSs

11. Recommendations Restructuring and simplification of national systems
Setting up clear targets for experts
Secretariat supporting the system

12. Recommendations More trust necessary – role of managers
Consistency in quality of dossiers
Consistency between experts in each MS

13. Thank you for your attention!
Name: Pavel Minář State phytosanitary Administration Adress: Zemědělská 1a, Brno,