1. Harmonisation in the Northern zone Lise Nistrup Jørgensen
or in the EU?
Crop Protection
EU regulatory conf.
Brussel March 2015
Lise Nistrup Jørgensen
Dept. of Agroecology
Aarhus University, Denmark
Made i collaboration with Per Kudsk and Solvejg Mathiasen

2. EPPO versus EU Zones EPPO comparable climate EU-authorization zones
Uniform principles – 1107/ entered into force by June 14, 2011
Applicants submit EU zonal applications
EPPO comparable climate
EU-authorization zones
To set the scene let us take a look at the map so everybody is familar with the countries in the North zone. The North zone consists of 6 EU member states – Sweden, Finland, Estonia, Latvia, Lithuania and Denmark. However we also consider Norway to be part of the North zone as Norway has decided to follow the same principles regarding pesticide registration as the EU. Includes two zones of comparble climate: Maritime and NE zone.
The Central zone includes 3 climatic zones (Maritime, NE and SE)
The South zone includes Mediterranean and Maritime zone

3. Challenges within zones
Evaluators need knowledge on farming systems, climatic conditions, crops and cropping systems, and registered pesticides in the zone
Communication between evaluators within the zone and with companies
Common agreement on data requirements
Trust in other MS evaluators

4. Differences in climate in the region
Precipitation in season
Growing season
From : Jukka Salonen, Bent Bromand & Lise Nistrup Jørgensen (Eds.)

5. Crop production system
Average farm size (ha)
The agricultural area varies from around 1 mill. ha in Estonia and Norway to 3 mill. Ha in Sweden. Large parts of the agricultural areas are grown with permanent crops - mainly permanent pasture and meadows or forage which is grass areas in rotation. The arable land in Sweden and Finland is mainly in the middle and southern part and in Norway it is only the southern part. The arable area of Sweden, Finland and Denmark is more or less of similar size while the agricultural areas of Norway and Estonia are very small as large parts are grown with permanent pasture and meadows leaving only a very limited arable area. The figure on top of each bar shows the average farm size. In Norway and Lithuania are dominated by small farms with an average of 20 to 25 ha, while the average farm size in Sweden and Denmark is from 52 to 60 ha and surprisingly Estonia has the largest farm size of 67 ha.
Eurostat, 2007

6. Communication in NZ Meetings for evaluators once a year
Discussion and revision of Guidance paper
Discussion of basic topics (t.e. how we prefer table design for data presentation - by EPPO or EU zone?, organisation of data),
Information exchange
Discussion and information exchange with companies

7. History – NZ Guidance
Idea of a guidance paper was born in November 2009 during a Nordic-Baltic meeting on efficacy trials and efficacy evaluations
First draft circulated spring 2010 and discussed in June 2010
Second version circulated September 2010 and discussed November 2010
Third version available December 2010
Fourth version available June 2011 – discussed with companies January 2013
Fifth version since July 2014
New version in preparation – following meeting i February 2015 – updating tables
Guidance paper is not legally binding. It is a guidance document. It is recognised by national authorities and strongly recommended to follow by the national authorities. It is not static but undergo up-dates when necassary.

8. NZ Guidance paper List of content
Introduction
General requirements
Preliminary trials
Requirements for efficacy trials
Tank mixes and co-formulations
Phytotoxicity
Resistance
Quality and transformation processes
Succeeding crops
Adjacent crops
Plant parts for propagation
Non-target organisms
Annex 1 List of major uses and trial no. requirements
Annex 2 Acceptabel origin of supplemental efficacy data

9. Making zonals work
Data needs to be representative for the whole zone -
Harmonised zonal requirements for:
principals of acceptable efficacy
number of efficacy and crop safety trials (Annex 2)
Extrapolations between crops and pest (Annex 2)
Adverse effects
Definition of major and minor crops

10. Introduction to guidance document
Data generated according to relevant EPPO standards
Master label in English + national labels
(national labels cannot include uses not included in the master label)
If the GAP varies within the zone the submitted data must support different GAPs
Transition period of 3 years (July 2014)

11. Number of efficacy trials
NEW ACTIVE INGREDIENTS
Major uses
Minor uses
Fungicides and insecticides
8-10 trials
(4 dose response trials including 2 lower doses)
2-3 trials
(preferably including 1 lower dose)
Herbicides
(competitive crops)
(non-competitive crops)
(4 dose response trials including 1 lower dose)
Plant Growth Regulators
Dessicants

12. Number of efficacy trials
NEW FORMULATIONS OF EXISTING ACTIVE INGREDIENTS
Major uses
Minor uses
Fungicides and insecticides
3-4 trials including 1/1 and 1/2 N
1-2 trials including 1/1 and 1/2 N
Herbicides
Plant Growth Regulators
Dessicants

13. Target and extrapolation
Disease target
Crop
Extrapolate
No of trials
Wheat mildew
wheat (winter/spring)
triticale
4-6
Barley mildew
Barley (winter/spring)
Fusarium head bligth
Wheat (winter/spring)
Triticale, rye, oat, barley
3-5
Brown rust
Triticale
Rye
Yellow rust
Triticale, rye
Septoria
Late blight
Potatoes
6-8
sclerotinia
Oil seed rape
Other crops with sclerotinia

14. Data from Northern Zone
Data should cover extremes of conditions and main areas for the target (40-50%)
Number of trials depends on uniformity of target occurrence
Supplemental data from comparable climate, cropping conditions etc.
If effect is claimed against several harmful organisms data from at least 3-6 trials must be available for each target. 2-4 trials per weed species given on the lable.

15. Re-registration of existing products
Data from old trials including old non-GEP trials can be accepted
New data is required if:
New uses are included or recommended doses are changed
There is evidence that pest sensitivity has changed
The efficacy is considered to be lower than that of newer active ingredients

16. Requests to companies dRR
List of content of the application
Map on location of trials is a great help
Summary tables for
Trials in Northern zone
Supplemental data from
EPPO Maritime zone
EPPO North Eastern zone

17. Requests to companies dRR
dRR should not be a copy of the BAD but a summary of around 20 to 30 pages
Harmonised efficacy ranking of products (good, moderat, reduction) – stimulated from UK
Efficacy tables with min. and max. values of control, level of attack
Trials in the BAD should be organized properly to be able to track single trials

18. Making zonals work
TRUST is essential if MS shall accept evaluations from other MS
COMMUNICATION is necassary to harmonise requirements
INFORMATION EXCHANGE on zonal affairs is essential for making zonal evaluations
TRANSPARENCY facilitates a common understanding and good atmosphere between industri and evaluators

19. Harmonizing between zones
Common EPPO guidelines
Common GEP rules (!?)
Yearly European efficacy evaluator meeting
Minor use – coordinated efforts – on a voluntary basis
Common resistance risk approach – local data still needed

20. Thank you for your attention
FLAKKEBJERG
Thank you for your attention