PULSAR PLUS (BAS H) Page 1 of 28. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 28 REGISTRATION REPORT Part A Risk Management Product code: BAS H Product name(s): PULSAR PLUS Active Substance(s): Imazamox, 25 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 DETAILS OF THE AUTHORISATION PRODUCT IDENTITY CLASSIFICATION AND LABELLING 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... 9 Summary of the evaluation 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... 28

3 Page 3 of 28 PART A Risk Management The company BASF FRANCE SAS has requested marketing authorisation in France for the product PULSAR PLUS (product code: BAS H), containing 25 g/l imazamox for use as an 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 PULSAR PLUS (BAS H) where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of have been made using endpoints agreed in the EU peer review(s) of imazamox. This document describes the specific conditions of use and labelling required for France for the registration of. 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 BASF FRANCE SAS s application to market PULSAR PLUS (BAS H) in France as an 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 Imazamox 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 : Only uses as herbicide may be authorised. 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 imazamox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate. There is no EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance. A Review Report is available (SANCO/4325/2000-Final, 29 November 2002). 1.3 Regulatory approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and

4 Page 4 of 28 Occupational Health & Safety (Anses) 1 in the context of the zonal procedure for all Member States of the Southern 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 4th 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 French Food Safety Agency, Afssa, before 1 July 2010 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 Arrêté du 4 mai 2017 relatif à la mise sur le marché et à l'utilisation des produits phytopharmaceutiques et de leurs adjuvants visés à l'article L du code rural et de la pêche maritime 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 28 Where protection for data is being claimed for information supporting registration of PULSAR PLUS (BAS H), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 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) Authorisation number Function Applicant Composition Formulation type (code) Packaging herbicide BASF FRANCE SAS 25 g/l imazamox Soluble concentrate (SL) f-hdpe bottles (1L) f-hdpe containers (3L, 5L, 10 L) f-hdpe barrels (50 L) 2.2 Classification and labelling Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards - Environmental Hazardous to the aquatic environment Chronic Hazard, Category 2 hazards Hazard pictograms Signal word Hazard statements H411 Toxic to aquatic life with long-lasting effects Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) For the P phrases, refer to the extant legislation - See Part C for justifications of the classification and labelling proposals.

6 Page 6 of 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 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 buffer zone of 5 meters 8 with an unsprayed vegetated buffer zone of 5 meters to surface water bodies. To protect non-target plants, respect an unsprayed buffer zone of 5 meters to non-agricultural land Other phrases linked to the preparation Wear suitable personal protective equipment 9 : refer to the Decision in Appendix 1 for the details Re-entry period 10 : 6 hours Pre-harvest interval 11 : sunflower :F- Application must be made at growth stage BBCH 18 at the latest Other mitigation measures: - Use only on varieties of sunflower tolerant to imazamox The label must reflect the conditions of authorisation The legal basis for this is Titre III Article 12 of the French Order of 4th May 2017 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] If a tractor with cab is used, wearing gloves during application is only required when working with the spray mixture The legal basis for this is Titre I Article 3 of the French Order of 4th May 2017 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] According to the French Order of 4th May 2017, PHI cannot be lower than 3 days unless specifically stated in the assessment and decision.

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, 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. PPP (product name/code) active substance 1 PULSAR PLUS / BAS H imazamox Formulation type: Conc. of as 1: GAP rev. 1, date: 2017-october-27 SL 25g/L Applicant: Zone(s): Verified by MS: yes BASF FRANCE SAS southern professional use non professional use Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) 1 France Sunflower Only on varieties tolerant to imazamox F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Application Application rate PHI Method / L product / ha kg as/ha Water (days) Kind L/ha Timing / Growth stage of crop & season Max. number (min. interval between applications) a) per use b) per crop/ season F Weeds general SP a) 1(-) b) 1(-) a) max. rate per appl. b) max. total rate per crop/season a) 2.0 b) 2.0 a) max. rate per appl. b) max. total rate per crop/season a) 0.05 b) 0.05 min / max Remarks: 100 / 400 F Acceptable e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures Split application of the max. rate/ha in two applications acceptable Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (i) g/kg or g/l (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (k) The minimum and maximum number of application possible under practical conditions of use must be provided (l) PHI - minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions

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 PULSAR PLUS (or BAS H) is a soluble concentrate containing 25 g/l imazamox as substance active. 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 an odorless, yellow, free-flowing clear liquid of medium viscosity with no sediment and free from foreign matter. It is not explosive and has no oxidizing properties. The product is not flammable. It has a self-ignition temperature of 310 C. In aqueous solution (1%), it has a ph value of 4.0 at 22 C. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 C and 14 days at 54 C, neither the active ingredient content nor the technical properties were changed. The stability data indicate a shelf life of at least 1 year at ambient temperature when stored in f-hdpe. To update the dossier, the final report of the storage study of 2 years at ambient temperature is required. The formulation is not classified for the physical-chemical aspect Methods of analysis Analytical method for the formulation Analytical method for the determination of the active substance in the formulation is available and validated. As the active substance imazamox does not contain relevant impurity, no analytical method is required Analytical methods for residues Analytical methods are available in the Draft Assessment Report/this dossier and validated for the determination of residues of imazamox in plants (rice, green beans, sunflower seeds, dry peas, grapes), food of animal origin, soil, water (ground, surface and drinking water) and air. 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: Imazamox 9 mg kg bw/d ADI 3 mg kg bw/d ARfD AOEL Dermal absorption Not necessary 3 mg kg bw/d EU agreed endpoint EFSA, april 2016 EU agreed endpoint EFSA, april mg/kg bw/d EU agreed endpoint 2.25 mg kg bw/d EFSA, april 2016 Based on default values according to guidance on dermal absorption (Efsa 2012) and conclusions of EFSA (april 2016): Concentrate Spray dilution (used in formulation) (used in formulation) 25 g/l g/l Dermal absorption endpoints % 75 % 75 % Acute Toxicity containing 25 g/l imazamox has a low toxicity in respect to acute oral, inhalation and dermal toxicity and is not irritating to the rabbit skin or eye and is not a skin sensitiser.

9 Page 9 of 28 The classification proposed is as shown in Section Operator Exposure Summary of critical use patterns (worst cases): Crop F/G 12 Equipment Application rate L product/ha (g as/ha) Spray dilution (L/ha) Model Sunflower F Tractor mounted boom sprayer 2 (50 g imazamox/ha) German BBA model Considering proposed uses, operator systemic exposure was estimated using the German BBA model: Crop Equipment PPE and/or working coverall % AOEL Imazamox 14 mkd % AOEL Imazamox 2.25 mkd* Sunflower Tractor mounted boom sprayer Working coverall and gloves during mixing/loading and application < 0.1 % 0.2 % * EFSA Journal 2016;14(4): The proposed reference values are different than those mentioned in the review report SANCO/4325/2000-final(European Commission, 2002). According to the model calculations, it can be concluded that the risk for the operator using PULSAR PLUS (BAS H) 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 < 0.1 % of the AOEL of imazamox (when the AOEL of 14 and 2.25 mg/kg bw/d are used). It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to PULSAR PLUS (BAS H) Worker Exposure is used as herbicidal treatment on several crops where there is no need to re-enter the treated area after application. Worker exposure is considered not relevant Resident Exposure Residential exposure was assessed according to Martin et al. (2008). Exposure is estimated to % of the AOEL and 0.004% of imazamox for adults and children, respectively. When the AOEL of 2.25 mg/kg bw/d is used, exposure is estimated to 0.013% of the AOEL and 0.024% of imazamox for adults and children, respectively. It is concluded that there is no unacceptable risk to the resident exposed to Residues and Consumer Exposure Overall conclusion The data available are considered sufficient for risk assessment. An exceedance of the current MRL of 0.05 mg/kg 12 Open field or glasshouse

10 Page 10 of 28 in sunflower seed for imazamox as laid down in Reg. (EU) 396/2005 is not expected. The chronic and the short-term intakes of imazamox residues are unlikely to present a public health concern. As far as consumer health protection is concerned, France agrees with the authorization of the intended uses 13. According to available data, no specific mitigation measures should apply. Data gaps None. Summary of the evaluation The preparation is composed of imazamox. Summary for imazamox Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg 2016/567 Chronic risk for consumers identified? Acute risk for consumers identified? / Sunflower Yes Yes Yes Yes Yes/No No No none Comments The effects of processing on the nature of imazamox residues have been investigated. Data on effects of processing on the amount of residue have been submitted. These data were not considered for risk assessment. 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. Summary for Crop PHI for PHI/ Withholding period* sufficiently PULSAR supported for PLUS (BAS H) proposed by Imazamox applicant PHI for PULSAR PLUS (BAS H) proposed by zrms Sunflower BBCH18 Yes F, BBCH 18 / zrms Comments (if different PHI proposed) * 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 substance 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 imazamox 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. 13 Consumer risk was also assessed in light of recent changes in toxicological reference values, including a decrease in the ADI and the setting of an ARfD (EFSA, 2016). Considering the GAPs of the sustained uses for this preparation, chronic and acute exposures to the consumer are lower than these new toxicological reference values.

11 Page 11 of 28 PEC soil and PECsw derived for the active substance and its metabolites are used for the ecotoxicological risk assessment, and mitigation measures are proposed. PECgw for imazamox and its metabolites do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO 221/ Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses. Based on vapour pressure and DT 50 calculation, no significant contamination of the air compartment is expected for the intended uses Ecotoxicology Effects on Terrestrial Vertebrates Effects on Birds The risk assessment for birds is carried out following the guidance document of EFSA/2009/1438. Under the conservative assumptions of the screening step, all TER A values and all TER lt for imazamox exceed the trigger, indicating an acceptable risk to birds. Effects on Terrestrial Vertebrates Other Than Birds The risk assessment for mammals is carried out following the guidance document of EFSA/2009/1438. Under the conservative assumptions of the screening step, all TER A values and all TER lt for imazamox exceed the trigger, indicating an acceptable risk to mammals Effects on Aquatic Species The standard risk assessments provided for the formulated product, the active substance imazamox and its major metabolites demonstrate that application of in sunflowers according to good agricultural practice will an acceptable risk to aquatic ecosystems if no-sprayed vegetated filter strips of 5 m are considered Effects on Bees and Other Arthropod Species Effects on Bees The calculated HQs for acute oral and acute contact exposure of honeybees to imazamox and PULSAR PLUS (BAS H) (tested as comparable solo-formulation BAS H) are below the trigger value of 50. The proposed uses of according to good agricultural practice present an acceptable risk to bees. Effects on Arthropods Other Than Bees The calculated HQ values of the first tier risk assessment are below the trigger value of 2 for T. pyri and A. rhopalosiphi indicating an acceptable in-field and off-field risk to non-target arthropods following application of to sunflower Effects on Earthworms and Other Soil Macro-organisms Acute studies on earthworms were performed with BAS H (tested as comparable solo-formulation PULSAR PLUS (BAS H)) and imazamox. In the risk assessment, the acute TER values exceeded the trigger value of 10. Chronic studies were carried out with BAS H (tested as comparable solo-formulation PULSAR PLUS (BAS H)) on earthworms and collembolans. The chronic risk of the metabolites CL and CL was assessed on earthworms and of CL also on collembolans. In the risk assessment, all TER values exceeded the trigger value of 5 for chronic exposure. 14 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 An organic matter decomposition study was carried out with CL and it was concluded that acceptable effects on organic matter breakdown processes are expected Effects on Soil Non-target Micro-organisms (tested as the comparable solo-formulation PULSAR PLUS (BAS H)) had no significant effect on soil micro-organisms at mg/kg dry soil, corresponding to mg imazamox/kg dry soil. This is higher than the maximum PEC soil of mg imazamox/kg dry soil. The NOEC values of the imazamox metabolites CL and CL are higher than the respective worstcase PEC values (tested as the comparable solo-formulation PULSAR PLUS (BAS H)) had no significant effect on soil micro-organisms at mg/kg dry soil, corresponding to mg imazamox/kg dry soil. This is higher than the maximum PEC soil of mg imazamox/kg dry soil. The NOEC values of the imazamox metabolites CL and CL are higher than the respective worstcase PEC values Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) The risk assessment based on seedling emergence data demonstrated no unacceptable effects for all tested plant species. The risk assessment based on vegetative vigour data still presents a risk when considering a 5 m buffer zone (TER = 4.9). The refined risk assessment using the HC 5 derived from a SSD is not accepted by zrms as the SSD curve does not fit to the points, which is confirmed by the results of the tests for normality. However, given the sensitivity of the tomato compared to other species, considering that 10 species were tested and that the TER value is close to the trigger, it is the opinion of zrms to consider an acceptable risk for non-target plants when considering a 5 meter buffer zone Efficacy The product complies with the Uniform Principles. Considering the data submitted: the efficacy of PULSAR PLUS (BAS H) is considered as satisfying the selectivity of PULSAR PLUS (BAS H) is considered as satisfying only on sunflower varieties tolerant to imazomox. the risk of negative impact (yield, quality, propagation, succeeding crops, adjacent crops) is considered as acceptable. There is a risk of resistance appearance or development to imazamox requiring a monitoring.

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 french 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 A monitoring of resistance to imazamox should be put in place (one monitoring for all products based on imazamox), mainly on Ambrosia artemisiifolia and sunflower (considered as weed in succeeding crops). Any new information which would change the resistance risk analysis should immediately be provided to Anses. In all cases a report on the results of the monitoring put in place should be provided at the next imazamox renewal Post-authorisation data requirements The French Decision requests the submission of post-authorisation confirmatory pieces of information within 24 months regarding: - The final report of the storage study of 2 years at ambient temperature 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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20 Page 20 of 28 Appendix 2 Copy of the draft product label as proposed by the applicant

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