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Harmonisation in the Northern zone or in the EU? Lise Nistrup Jørgensen Dept. of Agroecology Aarhus University, Denmark Crop Protection EU regulatory conf.

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Presentation on theme: "Harmonisation in the Northern zone or in the EU? Lise Nistrup Jørgensen Dept. of Agroecology Aarhus University, Denmark Crop Protection EU regulatory conf."— Presentation transcript:

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

2 EPPO versus EU Zones EPPO comparable climateEU-authorization zones Uniform principles – 1107/ entered into force by June 14, 2011 Applicants submit EU zonal applications

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 seasonGrowing season From : Jukka Salonen, Bent Bromand & Lise Nistrup Jørgensen (Eds.)

5 Crop production system Eurostat, 2007 Average farm size (ha)

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

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 usesMinor 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) 8-10 trials (4 dose response trials including 2 lower doses) 2-3 trials (preferably including 1 lower dose) Herbicides (non-competitive crops) 8-10 trials (4 dose response trials including 1 lower dose) 2-3 trials (preferably including 1 lower dose) Plant Growth Regulators8-10 trials (4 dose response trials including 1 lower dose) 2-3 trials (preferably including 1 lower dose) Dessicants8-10 trials (4 dose response trials including 1 lower dose) 2-3 trials (preferably including 1 lower dose)

12 Number of efficacy trials NEW FORMULATIONS OF EXISTING ACTIVE INGREDIENTS Major usesMinor uses Fungicides and insecticides 3-4 trials including 1/1 and 1/2 N 1-2 trials including 1/1 and 1/2 N Herbicides3-4 trials including 1/1 and 1/2 N 1-2 trials including 1/1 and 1/2 N Plant Growth Regulators3-4 trials including 1/1 and 1/2 N 1-2 trials including 1/1 and 1/2 N Dessicants3-4 trials including 1/1 and 1/2 N 1-2 trials including 1/1 and 1/2 N

13 Target and extrapolation Disease target CropExtrapolateNo of trials Wheat mildewwheat (winter/spring)triticale4-6 Barley mildewBarley (winter/spring)4-6 Fusarium head bligth Wheat (winter/spring)Triticale, rye, oat, barley 3-5 Brown rustWheat (winter/spring)Triticale Rye 4-6 Yellow rustWheat (winter/spring)Triticale, rye4-6 SeptoriaWheat (winter/spring)Triticale4-6 Late blightPotatoes6-8 sclerotiniaOil seed rapeOther crops with sclerotinia 4-6

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 FLAKKEBJERG Thank you for your attention


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