Training session File Note and Registration Report, 23 rd October Registration report : Partim Fate and Behavior in the environment 23 rd October 2006S. Vanhiesbecq FPS Health, Food Chain Safety and Environment DG Animals, Plants and Food Service Pesticides and Fertilizers

2 Overview Registration Report 2 parts to be completed : PART A : RISK MANAGEMENT PART B : DETAILED SUMMARY OF THE RISK ASSESSMENT

3 Part A : Risk Management 1.Details of the application 2.Details of the authorization 2.2 Classification and labelling 3.Risk Management 3.1 Reasoned statement of the overal conclusions taken in accordance with the Uniform Principles 3.2Conclusions 3.3Further information to permit a decision to be made or to support a review of conditions and restrictions associated with the authorisation

4 Part A - Example of reasoned statetment for F&B

5 Part B of the Registration Report – General structure 6. Environmental fate and behavior 6.0 List of Endpoints from the Review Report 6.1.Fate and Behavior in Soil a) New studies/synthesis b) Risk Assessment c) Conclusion 6.2.Fate and Behavior in Water a) New studies/synthesis b) Risk Assessment c) Conclusion 6.3. Fate and Behavior in Air New studies/synthesis + Conclusion Note : table with identity of the a.s and its metabolites required

6 Part B of the Registration Report – General structure 6. Environmental fate and behavior 6.0 List of Endpoints from the Review Report 6.1.Fate and Behavior in Soil a) New studies/synthesis b) Risk Assessment c) Conclusion 6.2.Fate and Behavior in Water a) New studies/synthesis b) Risk Assessment c) Conclusion 6.3. Fate and Behavior in Air New studies/synthesis + Conclusion Note : table with identity of the a.s and its metabolites required

7 6.0 List of Endpoints : extract from Review Report Source : Reference of the Review Report !

8 Table with identity of the a.s. and metabolites Code numberIUPAC nameMetabolite found Chemical Structure ZZ 142Dummy X (active substance) - ZZ 1421Dummy XY (met 1) Sediment (21%)

9 Part B of the Registration Report – General structure 6. Environmental fate and behavior 6.0 List of Endpoints from the Review Report 6.1.Fate and Behavior in Soil a) New studies/synthesis b) Risk Assessment c) Conclusion 6.2.Fate and Behavior in Water a) New studies/synthesis b) Risk Assessment c) Conclusion 6.3. Fate and Behavior in Air New studies/synthesis + Conclusion Note : table with identity of the a.s and its metabolites required

10 a) Studies/synthesis (for each compartment) 1) New submitted studies What kind of new data ? New annex II studies required for a national registration Recalculation of the endpoints following recent guidelines Detailed description and assessment are required. What kind of template to be used ? Name/reference/author of the study Author Guideline GLP status Materials and methods Findings Conclusions & Assessment

11 a) Studies/synthesis (2) 2) Synthesis - summary on the Endpoints characterising the behavior of the a.s. and its metabolites in the Environment - requirement for new data (Annex II studies, recalculation of endpoints) - DT50/DT90 trigger values for higher tier studies  AIM : Identification of Endpoints used in the Risk Assessment

12 Part B of the Registration Report – General structure 6. Environmental fate and behavior 6.0 List of Endpoints from the Review Report 6.1.Fate and Behavior in Soil a) New studies/synthesis b) Risk Assessment c) Conclusion 6.2.Fate and Behavior in Water a) New studies/synthesis b) Risk Assessment c) Conclusion 6.3. Fate and Behavior in Air New studies/synthesis + Conclusion Note : table with identity of the a.s and its metabolites required PECsoil and PECgw

13 Estimation of PECsoil a) Formulation Initial PEC values (excelsheets b) Active substance/metabolites (if needed) - Initial, short and long term PECsoil (actual and time weighted average values) - Accumulation (plateau concentration determined by soil accumulation studies or modelling «Soil persistence models and EU registration» 7617/VI/96

14 Estimation of PECsoil - initial, short and long term Which kinetic has been used to derive degradation parameter ? (SFO,…)

15 Estimation of PECsoil - initial, short and long term(2)

16 Estimation of PECsoil - accumulation Plateau average concentration Plateau maximum concentration

17 Estimation of PECgw PECgw calulated with : - FOCUS Models (like PEARL or PELMO) with the most relevant European FOCUS scenarii for Belgium (Châteaudun, Hamburg, Okehampton, Kremsmünster) - FOCUS Model PEARL with the Belgian scenarii - PELEP (actually : revision of soils parameters) Note : Input parameters in line with the FOCUS recommendations Metabolites with PECgw exceeding 0,1 µg/L : evaluation of their relevance with guideline Sanco/221/2000 (limit : 10 µg/L)

18 Estimation of PECgw - Example of presentation for study

19 Estimation of PECgw - Example of presentation for study

20 Conclusion for the Compartment Soil Does the product comply with the Uniform Principles ? especially for - persistence - leaching to groundwater

21 Part B of the Registration Report – General structure 6. Environmental fate and behavior 6.0 List of Endpoints from the Review Report 6.1.Fate and Behavior in Soil a) New studies/synthesis b) Risk Assessment c) Conclusion 6.2.Fate and Behavior in Water a) New studies/synthesis b) Risk Assessment c) Conclusion 6.3. Fate and Behavior in Air New studies/synthesis + Conclusion Note : table with identity of the a.s and its metabolites required PECsw and PECsed

22 Estimation of PECsw and PECsed a) Formulation (drift) PECsw calculated with excel sheets avalaible on in accordance with ‘ordinary’ national registration anti-drift measure (list of drift reducing equipments) initial PECvalues b) Active substance/metabolites (drift + drainage/run-off) PECsw calculated with FOCUS Models STEP 1 – 4 (D3, D4 and R1) European models are needed for a mutual recognition. initial, short and long term values needed if not present in the DAR

23 The tiered FOCUS surface water system Step 1 : single application, single fixed scenario FOCUS STEP 1-2 Calculator Step 2 : multiple applications, regional scenarios FOCUS STEP 1-2 Calculator Step 3 : Advanced modelling, multiple regional scenarios SWASH, MACRO, PRZM, TOXSWA Step 4 : Refined modelling field scale : SWASH, MACRO, PRZM, TOXSWA Only the most suitable Step is required to assess the risk for water organisms

Training session File Note and Registration Report, 23 rd October Estimation of PECsw/sed- Example of presented results

Training session File Note and Registration Report, 23 rd October Estimation of PECsw/sed- Example of presented results

26 Conclusion for the Compartment Water Does the product comply with the Uniform Principles ? especially for - water organisms See Ecotox for TERvalues

27 Part B of the Registration Report – General structure 6. Environmental fate and behavior 6.0 List of Endpoints from the Review Report 6.1.Fate and Behavior in Soil a) New studies/synthesis b) Risk Assessment c) Conclusion 6.2.Fate and Behavior in Water a) New studies/synthesis b) Risk Assessment c) Conclusion 6.3. Fate and Behavior in Air New studies/synthesis + Conclusion Note : table with identity of the a.s and its metabolites required

fate & behavior in Air Details of the evaluation : - Concise summary on the Endpoints (behavior in the Environment) Conclusion : Summary

Training session File Note and Registration Report, 23 rd October Thank you for your attention