SIMBA (MESOTRIONE 100 SC ) Page 1 of 28. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 28 REGISTRATION REPORT Risk Management Product code: MESOTRIONE 100 SC Product name(s): SIMBA Active Substance(s): Mesotrione, 100 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation)

2 Page 2 of 28 Table of Contents 1 DETAILS OF THE APPLICATION APPLICATION BACKGROUND ACTIVE SUBSTANCE APPROVAL REGULATORY APPROACH DATA PROTECTION CLAIMS LETTER(S) OF ACCESS... 5 DETAILS OF THE AUTHORISATION PRODUCT IDENTITY CLASSIFICATION AND LABELLING Classification and labelling under Directive 99/45/EC Classification and labelling in accordance with Regulation (EC) No1272/ Other phrases in compliance with Regulation (EU) No 547/ Other phrases linked to the preparation PRODUCT USES RISK MANAGEMENT REASONED STATEMENT OF THE OVERALL CONCLUSIONS TAKEN IN ACCORDANCE WITH THE UNIFORM PRINCIPLES Physical and chemical properties Methods of analysis Mammalian Toxicology Residues and Consumer Exposure Environmental fate and behaviour Ecotoxicology Efficacy CONCLUSIONS ARISING FROM FRENCH ASSESSMENT SUBSTANCES OF CONCERN FOR NATIONAL MONITORING FURTHER INFORMATION TO PERMIT A DECISION TO BE MADE OR TO SUPPORT A REVIEW OF THE CONDITIONS AND RESTRICTIONS ASSOCIATED WITH THE AUTHORISATION Post-authorisation monitoring Post-authorisation data requirements Label amendments APPENDIX 1 COPY OF THE FRENCH DECISION APPENDIX 2 COPY OF THE DRAFT PRODUCT LABEL AS PROPOSED BY THE APPLICANT APPENDIX 3 LETTER(S) OF ACCESS... 27

3 Page 3 of 28 PART A Risk Management The company HELM AG has requested marketing authorisation in France for the product SIMBA (formulation code: MESOTRIONE 100 SC), containing 100 g/l mesotrione for use as a herbicide. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C, and where appropriate the addenda for France. The information, data and assessments provided in Registration Report, Part B include assessment of further data or information as required at national registration by the EU peer review. It also includes assessment of data and information relating to SIMBA (MESOTRIONE 100 SC) where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of SIMBA (MESOTRIONE 100 SC) have been made using endpoints agreed in the EU peer review of mesotrione. This document describes the specific conditions of use and labelling required for France for the registration of SIMBA (MESOTRIONE 100 SC). Appendix 1 of this document provides a copy of the French Decision. Appendix 2 of this document is a copy of the draft product label as proposed by the applicant. Appendix 3 of this document is a copy of the letter(s) of Access. 1 DETAILS OF THE APPLICATION 1.1 Application background The present registration report concerns the evaluation of HELM AG s application to market SIMBA (MESOTRIONE 100 SC) in France as a herbicide (product uses described under point 2.3). France acted as a zonal Rapporteur Member State (zrms) for this request and assessed the application submitted for the first authorisation of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Mesotrione Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. Specific provisions of Regulation (EU) No 540/2011 were as follows : PART A Only use as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mesotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. An EFSA conclusion is available (EFSA Journal 2016;14(3):4419). A Review Report is available (SANCO/1416/2001- final, 14 April 2003). 1.3 Regulatory approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 1 in the context of the zonal procedure for all Member States of the Southern 1 French Food Safety Agency, Afssa, before 1 July 2010

4 Page 4 of 28 zone, taking into account the worst-case uses ( risk envelope approach ) 2 the highest application rates over the. When risk mitigation measures were necessary, they are adapted to the situation in France. According to the French law and procedures, specific conditions of use are set out in the Decision letter. The French Order of 4 may provides that: - unless formally stated in the product authorisation, the pre harvest interval (PHI) is at least three days; - unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is five metres; - unless formally stated in the product authorisation, the minimum re-entry period is six hours for field uses and eight hours for indoor uses. Drift reduction measures such as low-drift nozzles are not considered within the decision-making process in France. However, drift buffer zones may be reduced under some circumstances as explained in Appendix 3 of the abovementioned French Order. The current document (RR) based on Anses s assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/2009 4, implementing regulations and French regulations. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A of the RR presents a summary of essential scientific points upon which recommendations are based and is not intended to show the assessment in detail. The conclusions relating to the acceptability of risk are based on the criteria indicated in Regulation (EU) No 546/2011 5, and are expressed as acceptable or not acceptable in accordance with those criteria. Finally, the French Order of 26 March provides that: - an authorisation granted for a reference crop applies also for linked crops, unless formally stated in the Decision - the reference and linked crops are defined in Appendix 1 of that French Order. Thus, at French national level, possible extrapolation of submitted data and the corresponding assessment from reference crops to linked ones are undertaken even if not clearly requested by the applicant in their drr, and a conclusion is reached on the acceptability of the intended uses on those linked crops. The aim of this Order, mainly based on the EU document on residue data extrapolation 7 is to supply minor crops with registered plant protection products. Therefore the GAP table (Section 2.3) and Decision may include uses on crops not originally requested by the applicant. The Decision, as reproduced in Appendix 1, takes also into account national provisions, including national mitigation measures. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of SIMBA (MESOTRIONE 100 SC), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections SANCO document risk envelope approach, European Commission (14 March 2011). Guidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach ; SANCO/11244/2011 rev. 5 REGULATION (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC COMMISSION REGULATION (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products SANCO document guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs : SANCO/ 7525/VI/95 - rev.9

5 Page 5 of Letter(s) of Access Not necessary : the applicant has provided sufficient data to show that access is not required. 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) SIMBA (MESOTRIONE 100 SC) Authorisation number Function Applicant Composition Formulation type (code) Herbicide HELM AG 100 g/l mesotrione Suspension concentrate (SC) Packaging HDPE (1 L, 5 L, 10 L, 20 L) 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Acute toxicity (oral), Category 4 Serious eye damage, Category 1 Environmental hazards Hazard pictograms Hazardous to the aquatic environment Acute Hazard, Category 1 Hazardous to the aquatic environment Chronic Hazard, Category 1 Signal word Warning Hazard statements H302 Harmful if swallowed H318 Causes serious eye damage H400 Very toxic to aquatic life H410 Very toxic to aquatic life with long lasting effects Precautionary statements For the P phrases, refer to the extant legislation

6 Page 6 of 28 Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) - - See Part C for justifications of the classification and labelling proposals Other phrases in compliance with Regulation (EU) No 547/2011 The authorisation of the preparation is linked for professional uses only to the following conditions: SP 1 SPe 3 SPe 3 SPe 3 SPe 3 Do not contaminate water with the product or its container. Do not clean application equipment near surface water. Avoid contamination via drains from farmyards and roads. To protect aquatic organisms respect an unsprayed vegetated buffer zone of 20 meters to surface water bodies for maize and sweet corn at 1.5 L/ha on soil with ph<7 To protect aquatic organisms respect an unsprayed vegetated buffer zone of 5 meters to surface water bodies for maize and sweet corn at 1.5 L/ha on soil with ph>7 or at 2 applications at 0.75 L/ha. To protect non-target plants respect an unsprayed buffer zone of 50 meters to non-agricultural land for maize and sweet corn for 1 application at 1.5 L/ha. To protect non-target plants respect an unsprayed buffer zone of 20 meters to non-agricultural land for uses on maize and sweet corn for 2 applications at 0.75 L/ha Other phrases linked to the preparation Wear suitable personal protective equipment: refer to the Decision in Appendix 1 for the details Re-entry period: 24 hours Pre-harvest interval: - Maize, sweet corn : F- Application must be made at growth stage BBCH 18 at the latest Other mitigation measures : - Do not store in a room where the temperature can exceed 40 C. - The label may include the following recommendations: - As a lot of different genitors can be used for maize seed production and as their sensitivity may vary, it can be considered as impossible to test the selectivity of one product on all those genitors and to insure that no risk on the propagation exists. It is on the behalf of the seed producer to consult the breeder before applying one product. The label must reflect the conditions of authorisation.

7 Page 7 of Product uses Please note: The GAP Table below reports the intended uses proposed by the applicant, and possible extrapolation according to French Order of 26 March 2014 (highlighted in green), evaluated and concluded as safe uses by France as zrms. Those uses are then granted in France. When the conclusion is not acceptable or not finalised, the intended use is highlighted in grey and the main reason(s) reported in the remarks. When a use is acceptable with GAP restrictions, the modifications of the GAP are in bold. Use should be crossed out when the applicant no longer supports this use. GAP rev., date: year-month-day (a, b) PPP (product name/code): SIMBA (MESOTRIONE 100 SC) Formulation type: SC Active substance 2: mesotrione Conc. of as 2: 100 g/l (c) Professional use: Zone(s): southern (d) Non professional use: Verified by MS: Field of use: yes herbicide Use- No. (e) Member state(s) Crop and/ or situation (crop destination / purpose of crop) F, Fn, Fpn G, Gn, Gpn or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Timing / Growth stage of crop & season Application Max. number Min. interval Application rate g as/ha Water PHI (days) a) per use between L/ha b) per crop/ applications season (days) L product / ha a) max. rate per appl. b) max. total rate per crop/season a) max. rate per appl. b) max. total rate per crop/season min / max Remarks: e.g. g safener/synergist per ha (f) Zonal uses (field or outdoor uses, certain types of protected crops) 1 FR Maize (fodder and grain), sweet corn F Annual grasses and broad leaves weeds Foliar spray BBCH (spring) a) 1 b) 1 - a) 1.5 b) 1.5 a) 150 b) F Acceptable 2 FR Maize (fodder and grain), sweet corn F Annual grasses and broad leaves weeds Foliar spray BBCH (spring) a) 2 b) 2 a) 14 b) 14 a) 0.75 b) 1.5 a) 75 b) F Acceptable (split application of the total application rate)

8 Page 8 of 28 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties The formulation SIMBA (MESOTRIONE 100 SC) is a suspension concentrate formulation. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is a beige homogeneous liquid with characteristic odour. It is not explosive and has no oxidizing properties. The product has a flash point higher than 400 C. It has a self-ignition temperature higher than 400 C. Explosive, oxidizing and flammability hazard properties should have been assessed according to Reg (EU) 1272/2008 requirements. In 1% aqueous solution, it has a ph value of 2.8 at 20 C. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 C and 8 weeks at 40 C, neither the active ingredient content nor the technical properties were changed. The stability data indicate a shelf life of at least 2 years at ambient temperature when stored in HDPE packaging. Its technical characteristics are acceptable for a suspension concentrate formulation. The formulation is not classified for the physical-chemical part Do not store the product in a room where the temperature can exceed 40 C.Methods of analysis An analytical method for the determination of active substance mesotrione is available and validated. No analytical method for the determination of relevant impurities of active substance mesotrione is submitted and is required at the re-approval of the active substance. Analytical methods are available in the draft assessment report (DAR) and in this dossier and validated for the determination of residues of mesotrione in plants (maize), soil, water (surface and drinking) and air. Nevertheless, it should be provided at the re approval of the active substance mesotrione, an analytical method and its ILV, fully validated (with confirmatory method if necessary), for the determination of mesotrione residue in animal matrices. The active substance is neither toxic nor very toxic hence no analytical method is required for the determination of residues in biological fluids and tissues Mammalian Toxicology Endpoints used in risk assessment : Active Substance: mesotrione ADI ARfD AOEL ADI ARfD AOEL Dermal absorption 0.01 mg kg bw/d 0.02 mg/kg bw mg/kg bw/d 0.01 mg kg bw/d 0.02 mg/kg bw EU (2003) EFSA (2016) mg/kg bw/d Based on an in vitro rat/human study performed on formulation according to guidance on dermal absorption (Efsa 2012): Concentrate (tested) Diluted formulation (tested) 100 g/l 0.88 g/l In vitro (human) % 3 9 Concentrate Spray dilution (used in formulation) (used in formulation) 100 g/l 0.25 g/l Dermal absorption endpoints % 3 32

9 Page 9 of Acute Toxicity SIMBA (MESOTRIONE 100 SC)containing 100 g/l mesotrione is harmful by oral route, has a low toxicity in respect to acute oral, inhalation and dermal toxicity and is not irritating to the rabbit skin but severely damaging the rabbit eye and is not a skin sensitiser Operator Exposure Summary of critical use patterns (worst cases) : Crop F/G Equipment Maize F Tractor-mounted/trailed boom sprayer, hydraulic nozzles Application rate L product/ha (g as/ha) 1.5 L/ha (150 g mesotrione/ha) Spray dilution (L/ha) Considering proposed uses, operator systemic exposure was estimated using the German BBA model : Crop Equipment PPE and/or working coverall Maize Tractor-mounted/trailed boom sprayer, hydraulic nozzles Working coverall and gloves during mixing/loading and application % AOEL (mesotrione ; AOEL= mg/kg bw/d) Model BBA % AOEL (mesotrione ; AOEL= mg/kg bw/d) According to the model calculations, it can be concluded that the risk for the operator using MESOTRIONE 100 SC is acceptable with a working coverall (90% protection factor) and gloves during mixing/loading and application. For details of personal protective equipment for operators, refer to the Decision in Appendix Bystander Exposure Bystander exposure was assessed according to EUROPOEM II. Exposure is estimated to 2.4 % of the AOEL of mesotrione or 7.2 % of the AOEL for mesotrione proposed by EFSA. It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to SIMBA (MESOTRIONE 100 SC) Worker Exposure SIMBA (MESOTRIONE 100 SC) is used as herbicidal treatment on several crops where there is no need to reenter the treated area after application. Worker exposure is considered not relevant. For details of personal protective equipment for workers, refer to the Decision in Appendix Resident Exposure Residential exposure was assessed according to Martin et al., model (2008). Exposure is estimated as following : % AOEL mesotrione mkd OA : 70% % AOEL mesotrione mkd OA : 50% Children Adult It is concluded that there is no unacceptable risk to the resident exposed to SIMBA (MESOTRIONE 100 SC) Residues and Consumer Exposure

10 Page 10 of 28 Overall conclusion The data available are considered sufficient for risk assessment. An exceedance of the current MRL of 0.01 mg/kg for mesotrione as laid down in SANTE/11707/2016 is not expected 8. The chronic and the short-term intakes of mesotrione residues are unlikely to present a public health concern 9. As far as consumer health protection is concerned, France as zrms agrees with the authorization of the intended uses. According to available data, no specific mitigation measures should apply. Data gaps No data gap identified Summary for mesotrione Use- No. Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance SANTE/1170 7/2016 Chronic risk for consumers identified? Acute risk for consumers identified? Comments 1 Corn (silage maize, sugar maize, forage and grain maize) 2 Sweet corn Yes Yes Yes Yes Yes (BBCH growth stage) Yes (BBCH growth stage) Yes Yes No No Yes Yes No No As residues of mesotrione do not exceed the trigger value defined in SANTE/11707/2016, there is no need to investigate the effect of industrial and/or household processing. Residues in succeeding crops have been sufficiently investigated taking into account the specific circumstances of the cgap uses being considered here. It is very unlikely that residues will be present in succeeding crops. Considering dietary burden and based on the intended uses, no significant modification of the intake was calculated for livestock. Further investigation of residues as well as the modification of MRLs in commodities of animal origin is therefore not necessary. Summary for MESOTRIONE 100 SC In Reg 2016/53, the residue definition for enforcement is the sum of mesotrione and MNBA (4-methylsulfonyl-2-nitro benzoic acid), expressed as mesotrione. However the Reg 2016/53 MRL values are those proposed in EFSA assessment 2015 according to different residue definitions (for enforcement and risk assessment): mesotrione only for plant and AMBA for animal commodities. So the residue definition in Reg 2016/53should be modified in accordance with the MRL values adopted. It should be noted that in EFSA conclusion (2016), the consumer dietary risk assessment could not be finalised with regard to products of animal origin as the genotoxic potential of AMBA in vivo could not be ruled out due to positive results obtained in an in vitro cytogenetic assay

11 Page 11 of 28 Crop PHI for Product code proposed by applicant PHI/ Withholding period* sufficiently supported for mesotrione PHI for MESOTRIONE 100 SC proposed by zrms zrms Comments (if different PHI proposed) Corn (fodder and grain) N/A (BBCH 12-18) Yes F (application BBCH 12-18) - Sweet Corn N/A (BBCH 12-18) Yes F (application BBCH 12-18) - NR: not relevant * Purpose of withholding period to be specified ** F: PHI is defined by the application stage at last treatment (time elapsing between last treatment and harvest of the crop) Environmental fate and behaviour The fate and behaviour in the environment have been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU conclusions were used to calculate PEC values for the active substances and its metabolites for the intended use patterns. In cases where deviations from the EU agreed endpoints were considered appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. The PEC of mesotrione and its metabolites in soil, surface water and groundwater have been assessed according to FOCUS guidance documents, with standard FOCUS scenarios to obtain outputs from the FOCUS models, and the endpoints established in the EU conclusions or agreed in the assessment based on new data provided. PECsoil and PECsw derived for the active substance and its metabolites are used for the ecotoxicological risk assessment, and mitigation measures are proposed. PECgw for mesotrione 10 and its metabolites do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO 221/ No unacceptable risk of groundwater contamination is expected from the intended uses of this preparation. Based on vapour pressure, information on volatilisation from plants and soil, and DT50 calculation, no significant contamination of the air compartment is expected for the intended uses Ecotoxicology The risk assessment of the formulation SIMBA (MESOTRIONE 100 SC) was performed according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review for active substance were used for the intended use patterns. In cases where deviations from the EU agreed endpoints were considered appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. Based on the guidance documents, the risks for birds, mammals, bees and other non-target arthropods, earthworms and other soil macro-organisms and micro-organisms are acceptable for all the intended uses. Mitigation measures are required for aquatic organisms and non-target plants. Use of SIMBA (MESOTRIONE 100 SC) (for 1 application at 1.5 L/ha for soil with ph<7), with a 20 m nospray buffer zone including 20 m vegetated buffer strip for maize and sweet corn, when applied adjacent to water and according to good agricultural practice, poses an acceptable risk to all non-target aquatic species Based on EFSA Scientific Report concerning mesotrione (EFSA, 2016), PECgw values for mesotrione and its metabolites (including AMBA considered relevant according to SANCO/221/2000), calculated for the intended uses on maize for the formulated product SIMBA, are below the regulatory threshold defined in regulation (EU) N 546/2011 Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council directive 91/414/EEC. Sanco/221/2000-rev10-final, 25 February 2003.

12 Page 12 of 28 Use of SIMBA (MESOTRIONE 100 SC) (for 1 application at 1.5 L/ha for soil with ph>7 and 2 applications at 0.75 L/ha), with a 5 m no-spray buffer zone including 5 m vegetated buffer strip for maize and sweet corn, when applied adjacent to water and according to good agricultural practice, poses an acceptable risk to all non-target aquatic species. Based on a probabilistic risk assessment an acceptable risk to non-target plants has been demonstrated following applications of Mesotrione 100 SC at a distance of 20 and 50 m from the treated area without the use of drift reducing nozzles for 2 applications of 0.75 L Mesotrione 100 SC /ha and 1 application of 1.5 L Mesotrione 100 SC /ha, respectively. As with any application of a herbicide, off-target drift onto adjacent vegetation should be minimized Efficacy Considering the data submitted : - the efficacy level of SIMBA (MESOTRIONE 100 SC) is considered as satisfactory for all requested uses. - the selectivity level of SIMBA (MESOTRIONE 100 SC) is considered as acceptable for all requested uses. - the risks of negative impact on yield, quality, are considered as negligible. As a lot of different genitors can be used for maize seed production and as their sensitivity may vary, it can be considered as impossible to test the selectivity of one product on all those genitors and to insure that no risk on the propagation exists. It is on the behalf of the seed producer to consult the breeder before applying one product. - the risk of negative impact on succeeding crops is considered as acceptable. Nevertheless, specific attention should be paid to susceptible succeeding crops. - the risk of negative impact on adjacent crops is considered as acceptable. Nevertheless, specific attention should be paid to susceptible adjacent crops. - the risk of resistance development or appearance to mesotrione is considered as low does not require a monitoring for the claimed use.

13 Page 13 of Conclusions arising from French assessment Taking into account the above assessment, an authorisation can be granted as proposed in Appendix 1 Copy of the product Decision. 3.3 Substances of concern for national monitoring No information stated. 3.4 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Post-authorisation monitoring No further information is required Post-authorisation data requirements No further information is required Label amendments The draft label proposed by the applicant in appendix 2 may be corrected with consideration of any new element under points (or 2.2.2), and The label shall reflect the detailed conditions stipulated in the Decision.

14 Page 14 of 28 Appendix 1 Copy of the French Decision

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22 Page 22 of 28 Appendix 2 Copy of the draft product label as proposed by the applicant

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27 Page 27 of 28 Appendix 3 Letter(s) of Access Not applicable.

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