OMNERA LQM (DPX-SGE G/L OD) Page 1 of 33. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 33 REGISTRATION REPORT Part A Risk Management Product code: DPX-SGE G/L OD Product name(s): OMNERA LQM Active Substance(s): fluroxypyr, 135 g/l thifensulfuron methyl, 30 g/l metsulfuron methyl, 5 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation)

2 Page 2 of 33 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 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... 31

3 Page 3 of 33 PART A Risk Management The company DUPONT SOLUTIONS (France) S.A.S. has requested marketing authorisation in France for the product, containing 135 g/l fluroxypyr (194,5 g/l fluroxypyrmeptyl), 30 g/l thifensulfuron methyl and 5 g/l metsulfuron methyl 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 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 of fluroxypyr, thifensulfuron methyl and metsulfuron methyl. 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 DUPONT SOLUTIONS (France) S.A.S. s application to market 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 this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Fluroxypyr Commission Implementing Regulation (EU) No 736/2011 of 26 July 2011 approving the active substance fluroxypyr, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. Specific provisions of Regulation (EU) No 736/2011 were as follows : PART A Only uses 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 fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall: (1) pay particular attention to the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil and/or with vulnerable climatic conditions; (2) pay particular attention to the risk to aquatic organisms.

4 Page 4 of 33 Conditions of authorisation shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the relevance of the impurities present in the technical specifications; (b) the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material; (c) the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr methoxypyridine; (d) the residue analytical methods for plants; (e) the fate of fluroxypyr esters in animal matrices; (f) the long-term risk for earthworms and soil organisms. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) and (b) by 1 July 2012 and the information set out in points (c), (d), (e) and (f) by 31 December An EFSA conclusion is available (EFSA Journal 2011; 9(3): 2091). A Review Report is available (SANCO/11019/2011 rev 3, 17 June 2011). Thifensulfuron methyl 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 thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States: must pay particular attention to the protection of groundwater; must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. An EFSA conclusion is available (EFSA Journal 2015; 13(7): 4201). A Review Report is available (SANCO/7577/VI/97-final, 12 December 2001). Metsulfuron methyl Commission Implementing Regulation (EU) 2016/139 of 2 February 2016 renewing the approval of the active substance metsulfuron-methyl, as a candidate for substitution, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011. Specific provisions of Regulation (EU) No 2016/139 were as follows : 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 metsulfuron-methyl, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: the protection of consumers,

5 Page 5 of 33 the protection of groundwater, the protection of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority by 30 September 2016 confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (IN-A4098) to confirm that this metabolite is not genotoxic and not relevant for risk assessment. An EFSA conclusion is available (EFSA Journal 2015; 13(1): 3936). A Review Report is available (SANTE/10319/2015 Rev 3, 11 December 2015). 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 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 12 September 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 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 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

6 Page 6 of 33 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 OMNERA LQM (DPX- SGE G/L OD), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access The applicant has provided the supporting data in Document K; the ownership of the data is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7. A copy of the letter(s) of access is reproduced in Part A, Appendix 3. 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function herbicide Applicant DUPONT SOLUTIONS (France) S.A.S. Composition 135 g/l fluroxypyr meptyl 30 g/l thifensulfuron methyl 5 g/l metsulfuron methyl Formulation type (code) Oil dispersion (OD) Packaging HDPE/PA containers (1 L, 5 L, 8 L, 10 L) HDPE-f containers (1 L, 5 L, 8 L, 10 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 Skin sensitisation cat. 1 Environmental hazards Hazard pictograms Aquatic Chronic cat. 1 Aquatic Acute cat. 1 7 SANCO document guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs : SANCO/ 7525/VI/95 - rev.9

7 Page 7 of 33 Signal word Warning Hazard statements H317 May cause an allergic skin reaction Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) H400 H410 Very toxic to aquatic life Very toxic to aquatic life with long lasting effects. For the P phrases, refer to the extant legislation EUH 066 Repeated exposure may cause skin dryness or cracking. 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 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 metres 8 to surface water bodies. To protect non-target plants, respect an unsprayed buffer zone of 5 metres 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 : 48 hours Pre-harvest interval 11 : F- Application must be made at growth stage BBCH [39] at the latest Other mitigation measures: - Do not store above 35 C - In view of the high persistence of the metabolite fluroxypyr methoxypyridine and the absence of toxicological data on this metabolite, root and tuber crops should not be grown as rotational crops during 10 month following an application with OMNERA LQM. The label may include the following recommendations: - Specific buffer zones should be recommended on the label to avoid negative impact of the drift on adjacent crops: 3 meters for onions and peas, 5 meters for oilseed rape, vegetables and soybean, 10 meters for tomato and potato and 15 meters on sugarbeet The label must reflect the conditions of authorisation The legal basis for this is Titre III Article 11 of the French Order of 12 September 2006 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 12 September 2006 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 12 September 2006, PHI cannot be lower than 3 days unless specifically stated in the assessment and decision.

8 Page 8 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. GAP rev. 1, date: (a, b) PPP (product name/code): Formulation type: OD Active substance 1: fluroxypyr Conc. of as 1: 135 g/l (c) Active substance 2: thifensulfuron methyl Conc. of as 2: 30 g/l (c) Active substance 3: metsulfuron methyl Conc. of as 3: 5 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) Zonal uses (field or outdoor uses, certain types of protected crops) 1 France Winter cereals (wheat, barley, rye, triticale, oat) F Broadleaf weeds Method / Kind Broadcast foliar applicatio n Timing / Growth stage of crop & season BBCH Do not apply in fall 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) a) 1 b) 1 - L product / ha a) max. rate per appl. b) max. total rate per crop/season a) 1 L b) 1 L a) max. rate per appl. b) max. total rate per crop/season a) 170 (135 g fluroxypyr, 5 g metsulfuron methyl, 30 g thifensulfuron methyl) b) 170 min / max Remarks: e.g. g safener/synergist per ha (f) acceptable ( 2 France Spring cereals (wheat, barley, oat, rye, triticale) F Broadleaf weeds Broadcast foliar applicatio n BBCH Spring application a) 1 b) 1 - a) 1 L b) 1 L a) 170 b) acceptable

9 Page 9 of 33 Remarks table heading: (a) (b) (c) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) Catalogue of pesticide formulation types and international coding system CropLife International Technical Monograph n 2, 6th Edition Revised May 2008 g/kg or g/l (d) (e) (f) Select relevant Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use. Remarks columns: 1 Numeration necessary to allow references 2 Use official codes/nomenclatures of EU Member States 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the use situation should be described (e.g. fumigation of a structure) 4 F: professional field use, Fn: non-professional field use, Fpn: professional and nonprofessional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at the moment of application must be named. 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated. 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application 8 The maximum number of application possible under practical conditions of use must be provided. 9 Minimum interval (in days) between applications of the same product 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha). 12 If water volume range depends on application equipments (e.g. ULVA or LVA) it should be mentioned under application: method/kind. 13 PHI - minimum pre-harvest interval 14 Remarks may include: Extent of use/economic importance/restrictions

10 Page 10 of 33 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties The formulation is an oil dispersion preparation. 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 that of light yellow liquid, with a moderately oily characteristic odor. It is not explosive and has no oxidizing properties. The product is not flammable and has a flash point superior of 140 C. It has a self-ignition temperature of 350 C. In 1 % aqueous solution, it has a ph value of 4.2 at 25 C. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 C and 12 weeks at 35 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/EVOH. As the stability was performed on HDPE/EVOH packaging, the HDPE/PA and F-HDPE packaging can be considered as acceptable. Its technical characteristics are acceptable for an OD formulation. The formulation is not classified for the physical-chemical aspect. The formulation must be stored at a temperature below 35 C Methods of analysis Analytical method for the determination of active substances in the formulation is available and validated. As the active substances do not contain relevant impurity, no analytical method is required. Metsulfuron methyl Analytical methods are available in the Draft Assessment Report/this dossier and validated for the determination of residues of metsulfuron methyl in dried plants, food of animal origin, soil, water (surface and drinking) and air. Thifensulfuron methyl Analytical methods are available in the Draft Assessment Report /this dossier and validated for the determination of residues of thifensulfuron-methyl in dried plants, food of animal origin, soil, water (surface and drinking) and air. Fluroxypyr meptyl Analytical methods are available in the the Draft Assessment Report /this dossier and validated for the determination of residues of fluroxypyr meptyl in plants (wet, oily, acidic and dry matrices), food of animal origin, soil, water (surface and drinking) and air. The active substances are 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: metsulfuron-methyl ADI 0.22 mg kg bw/d ARfD Not applicable AOEL 0.7 mg/kg bw/d ADI 0.22 mg / kg bw /d ARfD 0.25 mg / kg bw /d AOEL 0.25 mg / kg bw /d Dermal absorption Default values according to guidance on dermal absorption (Efsa 2012): Concentrate EU (2000) Efsa 2015 Spray dilution

11 Page 11 of 33 Active Substance: thifensulfuron-methyl ADI ARfD AOEL ADI ARfD AOEL Dermal absorption (used in formulation) (used in formulation) 5.17 g/l g/l Dermal absorption endpoints % mg kg bw/d Not applicable EU (2001) 0.07 mg/kg bw/d 0.01 mg kg bw/d 2 mg/kg bw/d Efsa mg/kg bw/d Default values according to guidance on dermal absorption (Efsa 2012): Concentrate Spray dilution (used in formulation) (used in formulation) g/l g/l Dermal absorption endpoints % Active Substance: Fluroxypyr (acid) and fluroxypyr-meptyl ADI ARfD AOEL Dermal absorption fluroxypyr Dermal absorption Fluroxypyrmeptyl Acute Toxicity 0.8 mg kg bw/d (90-day, acid) Not applicable EU (2011) 0.8 mg/kg bw/d (90-day, acid) Default values according to guidance on dermal absorption (Efsa 2012): Concentrate (used in formulation) 135 g/l Dermal absorption endpoints % Default values according to guidance on dermal absorption (Efsa 2012): Concentrate (used in formulation) g/l Spray dilution (used in formulation) 0.33 g/l Spray dilution (used in formulation) 0.51 g/l Dermal absorption endpoints % containing 5 g/l of metsulfuron-methyl, 30 g/l/ of thifensulfuronmethyl and 135 g/l of fluroxypyr (acid) 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 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 cereals F Tractormounted/trailed boom sprayer: hydraulic nozzles 1L/ha (5.17g/ha of metsulfuron methyl, g/ha of thifensulfuron methyl, 142.5g/ha of fluroxypyr BBA Considering proposed uses, operator systemic exposure was estimated using the German BBA model: Crop Equipment PPE and/or working coverall % AOEL metsulfuron (AOEL of 0.7 mg/kg bw/d UE 2001) % AOEL metsulfuron (new AOEL of 0.25 mg/kg bw/d proposed in EFSA % AOEL thifensulfuron methyl % AOEL fluroxypyr 12 Open field or glasshouse

12 Page 12 of 33 conclusion 2015) cereals Tractormounted/trailed boom sprayer: hydraulic nozzles Working coverall and gloves during mixing/loading and application According to the model calculations, it can be concluded that the risk for the operator using OMNERA LQM (DPX- SGE G/L OD) 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 metsulfuron-methyl, 0.2 % of the AOEL of thifensulfuron-methyl and 0.1 % of the AOEL of fluroxypyr. Considering the AOEL of metsulfuron-methyl of 0.25 mg/kg bw/d proposed in EFSA s conclusion (2015), bystander exposure is estimated to 0.01% of the AOEL. It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to OMNERA LQM (DPX-SGE G/L OD) 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. 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. 2008, and the UK CRD approach. Exposure is estimated to < 1% of the AOEL of fluroxypyr, metsulfuron methyl, thifensulfuron methyl. Considering the new AOEL of metsulfuron-methyl of 0.25 mg/kg bw/d proposed in EFSA s conclusion (2015), residential exposure is estimated to <1% of the AOEL for adult and child. It is concluded that there is no unacceptable risk to the resident exposed to OMNERA LQM (DPX-SGE G/L OD) Relevance of metabolites The expected estimated concentrations in groundwater exceed the threshold of 0.1 µg/l for metabolites IN-00581, IN-A4098 and IN-D5119 of metsulfuron-methyl (maximum values of µg/l, µg/l and µg/l respectively). Considering the available data, the metabolites IN and IN-D5119 are not relevant according to SANCO/221/2000. However, according to the available data, it is not possible to finalize the assessment of the toxicological non-relevance of metabolite IN-A4098. The expected estimated concentrations in groundwater exceed the threshold of 0.1 µg/l for metabolites IN-A4098, IN-L9225, IN-W8268, IN-L9223, IN-U5F72 and IN-JZ789 of thifensulfuron-methyl (maximum values of 0.34 µg/l, µg/l, µg/l, µg/l, µg/l and 1.35µg/L). Metabolites IN-L9225 IN-L922, IN-JZ789 and IN-U5F72 are not relevant according to SANCO/221/2000. As no information was provided by the applicant, it is impossible to finalize the assessment of the toxicological non-relevance of metabolite IN-A4098, IN-W8268.

13 Page 13 of 33 According to the guidance document, the PECgw >0.75 µg/l for metabolites IN-L9223 and IN-JZ789 (maximum values of and µg/l, respectively), a risk assessment for consumers of drinking water is carried out. The estimated exposure value of metabolite IN-L9223 will be compared to the TTC value (1.5 µg/kg bw/d). The parent DJA of 0.01 mg/kg bw/d will be used for metabolite IN-JZ789. Considering a bodyweight of 60 kg and a consumption of 2L of water per day, the consumer exposure represents 6.3% of the TTC value for IN-L9223 and 0.45% of the parent DJA for IN-JZ789. Metabolite maximum Concentration in groundwaters (µg/l) Theoretical ingestion µg/day µg/day TTC value or ADI (mg/kg bw/day) Adult, 60 kg bw, water consumption 2L/jour: IN-L IN-JZ The risk for consumers is considered acceptable Residues and Consumer Exposure % TTC or % ADI The data available are considered sufficient for risk assessment. An exceedance of the current MRL of 0.1 mg/kg for fluroxypyr, 0.01 mg/kg for metsulfuron-methyl and thifensulfuron-methyl as laid down in Reg. (EU) 396/2005 is not expected. The chronic intakes of fluroxypyr residues and the chronic and short-term intakes of metsulfuron-methyl and thifensulfuron-methyl residues are unlikely to present a public health concern. As far as consumer health protection is concerned, ANSES, France agrees with the authorization of the intended use(s). According to available data, the following specific mitigation measures are recommended: - In view of the high persistence of the metabolite fluroxypyr methoxypyridine and the absence of toxicological data on this metabolite, root and tuber vegetable crops should not be grown as rotational crops during 10 month following an application with. Post registration data For cereals, additional data are required in post-registration to confirm that the OD formulation used in this preparation does not lead to a worst residue level than the EC or WG formulations. Summary for fluroxypyr Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg. (EU) 2015/1040 Chronic risk for consumers identified? Acute risk for consumers identified? Comments 1 Spring wheat, spring barley 2 Winter wheat, winter barley, winter rye & triticale Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes / * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 No / Residues trials were performed with a EC formulation whereas bridging trials were not provided

14 Page 14 of 33 As residues of fluroxypyr do not exceed the trigger values defined in Reg (EU) No 283/2013, 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. Root and tuber vegetable crops should not be grown as rotational crops during 10 month after an application of. 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 thifensulfuron-methyl Use- No. Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg 617/2014 Chronic risk for consumers identified? Acute risk for consumers identified? Comments 1 Spring wheat, spring barley 2 Winter wheat, winter barley, winter rye & triticale Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes No As residues of thifensulfuron-methyl do not exceed the trigger values defined in Reg (EU) No 283/2013, 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 metsulfuron-methyl Use- No. Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg 617/2014 Chronic risk for consumers identified? Acute risk for consumers identified? Comments 1 Spring wheat, spring barley 2 Winter wheat, winter barley, winter Yes Yes Yes Yes Yes No No Yes Yes Yes Yes Yes No

15 Page 15 of 33 Use- No. Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg 617/2014 Chronic risk for consumers identified? Acute risk for consumers identified? Comments rye & triticale As residues of metsulfuron-methyl do not exceed the trigger values defined in Reg (EU) No 283/2013, 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. 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. Information on Crop PHI for OMNERA LQM (DPX- SGE G/L OD)proposed by applicant PHI/ Withholding period* sufficiently supported for Fluroxypyr Metsulfuronmethyl Thifensulfuronmethyl PHI DPX- SGE G/L OD proposed by zrms zrms Comments (if different PHI proposed) Spring wheat, spring barley F** (<BBCH39) Yes Yes Yes F (<BBCH39) Winter wheat, winter barley, winter rye & triticale F** (<BBCH 39) Yes Yes Yes F (<BBCH39) 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). Waiting periods before planting succeeding crops Waiting period before planting succeeding crops Crop group Led by fluroxypyr Led by thifensulfuronmethyl Led by metsulfuronmethyl Overall waiting period proposed by zrms for DPX-SGE G/L OD Root and tuber vegetables 10 months / / For root and tuber vegetable crops a waiting period of 10 months after treatment with fluroxypyr before planting or sowing is required 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 their metabolites for the intended use patterns. In cases where deviations from the EU agreed

16 Page 16 of 33 endpoints were considered appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. The PEC of fluroxypyr, metsulfuron-methyl, thifensulfuron-methyl and their 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. PEC soil and PECsw derived for the active substances and their metabolites are used for the ecotoxicological risk assessment. PECgw for active substances fluroxypyr, metsulfuron-methyl, thifensulfuron-methyl and their metabolites pyridinol, methoxypyridine, IN-F5438, IN-B5067, IN-B5685, IN-D5803, IN-00581, IN-NC148, IN-V7160, IN-L9225, IN- L9223, IN-U5F72, IN-JZ789, IN-A5546 and IN-V7160 do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO 221/ PECgw for metabolites IN-A4098 and IN-W8268 exceeding 0.1µg/L. Their non-relevance according to SANCO 221/2000 being not demonstrated, unacceptable risk of groundwater contamination for metabolites IN-A4098 and IN-W8268 cannot be excluded for the intended uses. Based on vapour pressure, information on volatilisation from plants and soil, and DT 50 calculation, no significant contamination of the air compartment is expected for the intended uses Ecotoxicology The ecotoxicological risk assessment of the formulation was performed according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU conclusions for the active substances and their metabolites 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. The TERa, TERst, and TERlt derived for proposed uses of indicate that this product poses an acceptable risk to birds. The TERst and TERlt for the proposed uses of indicate that it poses an acceptable acute and chronic risk to aquatic organisms, living in either the water or sediment. The TERa and TERlt for the proposed uses of indicate that this product poses an acceptable risk to mammals. The Qho and Qhc are <50. Therefore, will pose an acceptable risk to honey bees. No unacceptable adverse effects on ground or foliar dwelling beneficial arthropods are likely from use of OMNERA LQM (DPX-SGE G/L OD). The TERa and TERlt value exceeds the trigger of 10 and 5, respectively, for earthworms. Therefore, it can be concluded that and metabolites will pose an acceptable risk to earthworms. indicate that this product poses an acceptable risk to soil microflora when used according to Good Agricultural Practices. 13 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.

17 Page 17 of 33 The TER for the proposed uses of indicate that this product poses an acceptable risk to terrestrial non target plants when considering a buffer distance of 10 meter as mitigation measures. Based on the guidance documents, the risks for birds, mammals, bees and other non-target arthropods, earthworms, other soil macro-organisms and micro-organisms are acceptable for the intended uses Efficacy Considering the data submitted: - the efficacy of is considered as satisfying for all the intended uses, - the selectivity of is considered as acceptable for all the intended uses. - the risk of negative impact on yield, quality, transformation processes, propagation is considered as acceptable. - the risk of negative impact on succeeding crops and adjacent crops is considered as acceptable with some recommendations of uses - the risk of resistance development or appearance is considered as low for fluroxypyr and medium for metsulfuron methyl and thifensulfuron methyl. The association of the 3 active ingredients and the specific recommendations of uses allow to reduce the risk. A survey of resistance appearance to sulfonylureas should be continued. Comments on the agronomical practices : Following crops In the case of a normal crop rotation the following crops can be planted after application of OMNERA LQM (DPX- SGE G/L OD): In the autumn after cereal harvest: cereals, grasses, oil seed rape, beans, winter peas, vetch, and flax can be planted after ploughing. Alfalfa can also be cropped in the following autumn if OMNERA LQM (DPX-SGE G/L OD) is applied no later than April, and no other sulfonylurea is applied. The next spring: after application of annual crops as sunflower, sugar beet, maize, potatoes, soybean, flax, peas, beans, alfalfa, can be planted. In the absence of sufficient information is not recommended to grow vegetable, flowers, ornamental plants, bulbs, shrubs or trees within 16 months after the application of. Adjacent crops Specific buffer zones should be recommended on the label to avoid negative impact of the drift on adjacent crops: 3 meters for onions and peas, 5 meters for oil seedrape and soybean, 10 meters for tomato and tomato and 15 meters on sugarbeet. 3.2 Conclusions arising from French assessment Taking into account the above assessment, an authorisation cannot be granted (groundwater contamination by metabolites). A copy of the decision issued can be found 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

18 Page 18 of Post-authorisation monitoring A survey of resistance appearance and development to sulfonylureas should be continued Post-authorisation data requirements 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.

19 Page 19 of 33 Appendix 1 Copy of the French Decision

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25 Page 25 of 33 Appendix 2 Copy of the draft product label as proposed by the applicant

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31 Page 31 of 33 Appendix 3 Letter(s) of Access

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