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

EPPO versus EU Zones EPPO comparable climate EU-authorization zones Uniform principles – 1107/2009 - 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

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

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

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

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

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.

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

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

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)

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

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

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

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.

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

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

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

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

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

Thank you for your attention FLAKKEBJERG Thank you for your attention