ECPA, ECCA Regulatory Conference Evaluation and Authorisation of Plant Protection Products in the Northern Zone Common risk assessment of Plant Protection Products Crop Protection European Regulatory Conference 12 March 2015, Brussels Vilma Kludsuveit State Plant Service under the Ministry of Agriculture 12 March 2015, Brussels ECPA, ECCA Regulatory Conference

Assessment of PPP in the North Zone Implementing EU PPP authorisation provisions: MS participants of the process Historical overview and the outcome of pilot project Current process. Overview and outcome - focus on 2014 - issues considered by NZ SC harmonising different areas of assessment Concluding notes 12 March 2015, Brussels ECPA Regulatory Conference

MS -participants of the zonal assessment The 6 countries falling into the zone A- North Annex I, Reg.1107/20090 - Denmark Estonia Finland Latvia Lithuania Sweden and the two EFTA States Iceland Norway 12 March 2015, Brussels ECPA Regulatory Conference

ECPA Regulatory Conference Historical overview The outset - Pilot Project of work sharing, 2005; Dir.91/414/EEC first meeting: 5 Dec. 2005 Saku , Estonia. A primary meeting. Nordic and Baltic countries. Evaluators updated the situation on the first 5 PPPs selected. 10-11 May 2006, Helsinki, Finnish Environmental Institute, Helsinki. 42 participants, coordinators and risk assessors 11-12 June 2008, Riga, Latvia; 37 participants December 2009, Vilnius. Starting point to harmonization. Norway, July 2010, the need for NZ GD Further annual meetings hosted by different countries. Experts and Steering Committees. 2014 (LT/SE) and 2015 (SE/NO) 12 March 2015, Brussels ECPA Regulatory Conference

Crop Protection European Regulatory Conference Process before Reg. 1107/2009 zRMS/co-zRMS assessment based on Uniform Principles All areas of assessment covered: - identity, properties, methods; - toxicology and residues; - ecotoxicology; - fate and behavior in the environment; - biological efficacy. the EU Registration report template and guidance document applicable (Sanco/10798) Mini expert teams: one member from each country in the coordinating team (SC) and expert team 12 March 2015, Brussels Crop Protection European Regulatory Conference

The outcome of the pilot project Positive: MS expressed willingness to continue cooperation Sharing experiences and expertise Relatively harmonised approach (UP) Critical issues to all NZ MS identified Preparation for Zonal PPPs authorisation (Reg. 1107/2009) Possibility to further use risk assessment in all NZ MS (MR) NZ GD rev.0 Jan.2011 for Zonal Assessment (Reg.1107/2009) 12 March 2015, Brussels ECPA Regulatory Conference

Work sharing activities in the Zone in 2014 Teleconferences and meetings NZ Steering Committe 5 teleconferences; 2 face to face meetings (June and November) Meeting with Industry (6 November) in parallel: Teleconferences and e-consultations of different areas of assessment The outcome: NZ GD new revision (rev.3 of April 2014) based on agreement of NZ MS. 12 March 2015, Brussels ECPA Regulatory Conference

Issues considered by NZ SC in 2014 (1) Worksharing in the Zone: registration, re-registration of PPPs. Coordination. Inter-zonal issues followed - Art.43 and stringent deadlines - Art. 34 provisions and assessment of PPPs Comparative assessment Negligible exposure and Endocrine disruptors dRR for label extensions and relavant parts of assessment commenting on dRRs mixed applications (indoor & outdoor uses) planning future worksharing. Priorities CLP GHS process in MS optimising PPP authorization 12 March 2015, Brussels ECPA Regulatory Conference

Harmonising assessment in different areas (1) Considerations of zonally independent assessment Section 1. Identity and physical and chemical properties Identity: formulation changes, equivalence, comparability of formulations (dRR part C). Parallel trade; further procedures. Packaging. Shelf- life. Section 2. Residue analytical methods assessment (AII data). General consensus towards residue methods: the methods are EU agreed EP. Not to be re-assessed until re-approval of substance unless this is relevant (4 criteria). 12 March 2015, Brussels ECPA Regulatory Conference

Harmonising assessment in different areas(2) Toxicology Consensus towards non-prefessional uses reached. Assessment of PPPs for non-professional uses harmonised. NZ GD will be amended in by a separate chapter (2015). Background: Workshop in Stockholm Oct. 2013 (Tox., ecotox., fate) Riga workshop Nov.2014; 2TCs (March 2014 & February 2015). New EFSA GD (23 Oct.2014) Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products. EFSA Journal 2014; 12(10):3874, 55pp of 23 October 2014). Submitted to Standing Committee on plants, animals, food and feed for comments. Will be considered by NZ MS. Possibly higher level of the EU harmonized evaluation achievable. 12 March 2015, Brussels ECPA Regulatory Conference

Harmonising assessment in different areas (3) Ecotoxicology New interception values for orchards and spring cereals are relevant to NZ.  They will be updated in B & M GD (Northern zone Higher tier Risk Assessment for Birds and Mammals). New EFSA Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters. Considered in NZ to amend NZ GD.. New EFSA Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil will be considered. RIVM guidance (Report 601712006/2010) for summarizing and evaluating field studies with non-target arthropods will be considered in the NZ GD Critical issues: refinements for birds, mammals and aquatics. 12 March 2015, Brussels ECPA Regulatory Conference

Harmonising assessment in different areas(4) Fate and behaviour Ongoing project of Northern Zone ground water The aim to compare the scenarios at the EU level to the actual soil conditions in the NZ. To find out how sensitive and conservative they are. Update: final stage of project- draft report circulated for comments. Workshop 15-16 April 2015, Copenhagen. Project presentation to MS and industry. 12 March 2015, Brussels ECPA Regulatory Conference

Harmonising assessment in different areas (5) Efficacy assessment Quality of dossiers is of key importance. NZ MS apply the Guidance on requirements for efficacy data for zonal evaluation of a plant protection product in the Northern Zone Version 4, July 2014 The GD was discussed during NORBARAG meetings by the representatives of Industry and MS. Annex 1 of the NZ GD is currently under revision 12 March 2015, Brussels ECPA Regulatory Conference

ECPA Regulatory Conference Concluding Notes Harmonised views of MS to risk assessment and management is the best way to ensure not only plant health by availability of PPPs on the market but also the minimized risk to human and environment from PPPs. This is a rather challenging task. Not only because of scientific development and new technologies coming up but also new DR, CLP, transitional measures and the renewal of AS taken into account. Challenging task for the Member States. 12 March 2015, Brussels ECPA Regulatory Conference

Thank you for your attention! 12 March 2015, Brussels ECPA Regulatory Conference