biological dossier and cooperation in the Southern zone Focus on biological dossier and cooperation in the Southern zone Laurent Thibault and Véronique Mironet Anses - Efficacy Evaluation Unit for plant protection products and fertilisers ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Overview Issues with dossiers submitted and recommandations Cooperation between experts involved in biological efficacy New format for the dRR template Conclusion ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Issues with dossiers submitted and recommandations 1/4 Issues with dossiers submitted and recommandations Zonal level increase the complexity of dossiers and the evaluation process Need for a clear understanding of the intended uses (GAP) Between member states Including the major/minor uses To avoid inconsistencies between the GAP tables of the different sections of the dRR, the content of the dossier and the national application form ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Issues with dossiers submitted and recommandations 2/4 Issues with dossiers submitted and recommandations Efficacy trials : Do the data (or the rationale) support all the intended uses ? Justify the absence of data : e.g. to propose extrapolation Quantity is not quality : dRR should be more concise and standalone document Data not sufficiently summarized : put together ≠ sum up National addenda should be justified : specific use or specific practices ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015 4/17

Issues with dossiers submitted and recommandations In case of re-registration dossiers: In principle, all uses are re-registrations But if it is not this case, e.g. new use in zRMS then information should be given to zRMS : cMS where the product is registered zRMS is not able to conclude for the whole zone if the information is missing ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015 5/17

Issues with dossiers submitted and recommandations 4/4 Zones and dossiers: Dossiers should be adapted to each regulatory zone. Trials should be distributed in the whole regulatory zone. EPPO climatic zone is not always the best solution to sumarize trials (France is cut in two EPPO zone) To justify the distribution of trials within the zone Avoid a single european BAD, where we have to « pick » trials. But EPPO zones required by the majority of MS For each regulatory zone : 1 specific BAD and 1 specific dRR. ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Cooperation between experts involved in biological efficacy 1/3 Cooperation between experts involved in biological efficacy Zonal evaluation avoids duplication of work : As cMS, we are able to rely on the RR produced by other MS Save time and  workload Since June 2011 : Clear improvement of the quality of dRR received from applicants Clear trend in reduction of « national requirements » in the evaluation 1) But, we can loose time elsewhere ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Cooperation between experts involved in biological efficacy 2/3 Cooperation between experts involved in biological efficacy Exchanges on technical issues/interpretations should be improved between experts of MS of the southern zone Currently, the most common ‘exchange’ : By commenting tables on dRR (zonal evaluation) To share and to improve evaluation Transparency for MS and applicant Proposal by Anses to organise a face to face meeting between experts of the southern zone involved in biological efficacy in 2015 ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Cooperation between experts involved in biological efficacy 3/3 Cooperation between experts involved in biological efficacy Some Items for discussion in the face to face meeting e.g.: Minimum effective dose : need to be justified ? Distribution of trials / trial grouping Relation between GAP, conditions of trials, acceptability of deviation Trials : need for criteria to consider the trials valid or invalid ? ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

New format for the dRR template Another example of cooperation This work is a real way to share opinions of EU efficacy experts and to improve the cooperation between MS This new format should avoid duplication of work for MS and applicants and save time Leader of the Working group: BVL (Germany) One subgroup for each section of the dRR Chair of Efficacy subgroup : France ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Context and Method Calendar Members of the efficacy subgroup February 2012: Kick-off meeting July 2012: First version (FR) sent to subgroup for comments March 2013: 2nd Braunschweig Meeting (coordination ; point on all sections) November 2013: Face to face meeting – Paris (subgroup) January 2014: Final version (from the subgroup) sent to BVL May 2014: Presentation to ScoPAFF (SCFCAH = CPCASA) and sent for comments to all MS (27) July 2014: Comments back in France October 2014: Final version and reporting table, sent to BVL December 2014: Presentation to ScoPAFF (With new reformatting from BVL and accompanying documents from HSE (UK). Sending for comments to all MS (27) February 2014: Last final version and reporting table, sent to BVL March 2014: Final presentation to ScoPAFF ?? Members of the efficacy subgroup Chair: France (Anses) Grece (BPI) UK (HSE) Germany (JKI) Netherlands (CTGB) Danemark (AGRSCI) Hungary (NEBIH) ECPA In blue, MS integrated in the efficacy subgroup, later ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Some outcomes : table of contents Current chaptering Efficacy data … Effects on yield and quality Effect on yield Effect on quality Effects on transformation processes… Adverse effects Phytotoxicity to host crop ... Propagation Succeeding crops Adjacent crops Resistance New chaptering proposed (according to regulation 284, except MED) Adverse effects on treated crops Effects on yield Effects on quality Effects on transformation processes Observations on other undesirable or unintended side-effects Positive effects (efficacy...) versus adverse effects. Adverse effects on treated crops versus on other crops. A uniq chaptering for BAD, dRR, DAR and EU regulation 284/2013 (or almost) ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Some outcomes MS approaches when transforming a dRR into a RR: Deleting / rewriting Use of commenting boxes The chosen option(s) should be explained at the beginning of the RR Use of summary tables as much as possible, instead of text: in the template, examples of tables (with possibilities of modification) are proposed ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Conclusion Issues with dossiers submitted and recommandation Avoid overall dossiers for all zones Importance of adapting the dossier to the regulatory zone concerned Clear improvement of the quality of dRR received from applicants Still need to reduce the size of dRR (without reducing the quality) ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Conclusion Cooperation in the Southern zone So far : main exchanges by commenting tables on dRR Need to improve communication and have face to face meeting between efficacy evaluators of the southern zone: To share experiences To discuss and solve remaining technical open points ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Conclusion dRR template : A real way to share opinions of EU efficacy evaluators An exemplary democratic process: With its advantages: a collective document with high quality And its defects: 3 years of work An infinity of comments in an infinity of round trip of comments tables Always new comments of the same members of subgroup, despite the accepted modifications and a face to face meeting …☺ Next step planned: validation of the template to SCOPAFF ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015

Thank you for your attention laurent.thibault@anses.fr veronique.mironet@anses.fr ECCA & ECPA – Crop Protection European Regulatory Conference - Efficacy Pre-conference Workshop Brussels - 11 March 2015