MON (ROUNDUP 720) Page 1 of 48. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 48 REGISTRATION REPORT Risk Management Product code: MON Product name(s): ROUNDUP 720 Active Substance(s): Glyphosate, 720 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation)

2 Page 2 of 48 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 (see label in Appendix 2): 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... 48

3 Page 3 of 48 PART A Risk Management The company MONSANTO SAS has requested marketing authorisation in France for the product ROUNDUP 720 (formulation code: MON 79991), containing 720 g/l glyphosate 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 ROUNDUP 720 (MON 79991) where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of ROUNDUP 720 (MON 79991) have been made using endpoints agreed in the EU peer review of glyphosate. This document describes the specific conditions of use and labelling required for France for the registration of ROUNDUP 720 (MON 79991). 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 MONSANTO SAS s application to market ROUNDUP 720 (MON 79991) 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 Glyphosate Regulations 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. Commission Implementing Regulation (EU) 2015/1885 of 20 October 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-D, acibenzolar-smethyl, amitrole, bentazone, cyhalofop butyl, diquat, esfenvalerate, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), glyphosate, iprovalicarb, isoproturon, lambda-cyhalothrin, metalaxyl-m, metsulfuron methyl, picolinafen, prosulfuron, pymetrozine, pyraflufen-ethyl, thiabendazole, thifensulfuron-methyl and triasulfuron. 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 glyphosate, 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 the groundwater in vulnerable areas, in particular with respect to non-crop uses Specific provisions of Regulation (EU) 2015/1885 were as follows :

4 Page 4 of 48 The expiry date of the approval was extended to 30 June An EFSA conclusion is available (EFSA Journal 2015; 13(11): 4302 ). A Review Report is available (SANCO/6511/VI/99-final, 21 January 2002). 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 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 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 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 48 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 ROUNDUP 720, 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) ROUNDUP 720 (MON 79991) Authorisation number Function Applicant Composition Formulation type (code) Packaging herbicide MONSANTO SAS 720 g/kg glyphosate acid Water soluble granule (SG) LDPE 8 (1 kg, 5 kg and 10 kg) The preparation does not contain tallowamine (n CAS ). 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 Environmental hazards No classification No classification No classification Hazard pictograms - Signal word - Hazard statements - Precautionary statements For the P phrases, refer to the extant legislation 8 Low-density polyethylene

6 Page 6 of 48 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 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 9 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 10 : refer to the Decision in Appendix 1 for the details Re-entry period 11 : 6 hours Pre-harvest interval 12 : o Citrus, tree nuts, stone fruits : 21 days ; o Pome fruits : 28 days, o Grapes: 21 days o Olive (table and oil production) : 7 days (harvest only on tree); o Kiwi : 90 days ; o Banana : 1 day ; o Cereals (wheat et barley) : 7 days ; o Alfalfa : application during the vegetative period ; o inter-crops : 30 days Other mitigation measures: - When treating grape use agricultural practices or equipment that prevent fruits and leaves from coming into contact with the sprayed product. - Do not harvest fruits that have been in direct contact with soil. - For inter-row treatment of vegetable crop, use a specific sprayer to have no contact between crop and the spayed product. - Respect the mandatory recommendations dealing with maximum rate of application per crop of glyphosate based PPP, as stated in the Notice to all authorisation holders of glyphosate products13, published in the Official Journal of the French Republic on 8 October 2004), - As part of the good agricultural practices, the use of drift-reduction nozzles and/or suitable adjuvants bearing the label phrase drift control is recommended 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. Avis à tous les détenteurs d autorisations de mise sur le marché pour des spécialités commerciales à base de glyphosate JORF 8 octobre 2004 NOR : AGR V

7 Page 7 of 48 - Avoid glyphosate treatment on water-filled ditches or the adjacent ground. - In view of monitoring data on the contamination of surface water by glyphosate, it is highly recommended to set up appropriate mitigation measures such as environmental protection and restriction of use in vulnerable areas. These should be established or augmented at the level of the plot and / or drainage basin, in order to reduce and limit the contamination of surface water. - The use of recovery panels for devitalisation of vines is mandatory. - For perennial crops: The sum of the two applications must not exceed the maximum authorised rate of 2200 g glyphosate/ha. To notify users that the dose limitation for glyphosate in the plot concerns all glyphosate-based products (and not just a single product), the following label amendment is proposed: - Do not apply this or any other product containing glyphosate at greater than the maximum rates of application defined in the Notice to all authorisation holders of glyphosate products, published in the Official Journal of the French Republic on 8 October The label must reflect the conditions of authorisation.

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. When the conclusion is not acceptable, the intended use is highlighted in grey and the main reason(s) reported in the remarks. GAP rev.1, date: PPP (product name/code): ROUNDUP 720 Formulation type: (a, b) SG Active substance 1: Glyphosate Conc. of as 1: 720 g/l (c) Professional use: Zone(s): southern (d) Non professional use: Verified by MS: yes Field of use: herbicide Use- No Member state (s) Crop and/ or situation (crop destination / purpose of crop) 1 France Pre-emergence / pre-plant and post-plant treatment: * cereals * industrial crops * vegetables crops F G or I F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) annual grass broad-leaved method kind Spraying Application Application rate PHI (days) Max. number (min. kg, L product / ha g, kg as/ha Water interval between a) max. rate per L/ha applications) appl. a) per use b) max. total rate min / b) per crop/ season per crop/season max Timing / Growth stage of crop & season Actively growing Spring 2 a) 1.45 kg/ha 1 a) 3.00 kg/ha Perennial 1 a) 3.50 kg/ha a) max. rate per appl. b) max. total rate per crop/season a) 1.04 kg as/ha a) 2.09 kg as/ha a) 2.52 kg as/ha Vegetables: 30 d Cereals and industrial crops : F Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures Acceptable 2 France Post harvest treatment: * cereals * industrial crops * vegetables crops (all species) * stubbles F annual grass broad-leaved Spraying Actively growing Summer and Autumn 2 a) 1.45 kg/ha 1 a) 3.00 kg/ha Perennial 1 a) 3.50 kg/ha a) 1.04 kg as/ha a) 2.09 kg as/ha a) 2.52 kg as/ha Vegetables: 30 d Cereals and industrial crops : F Acceptable 3 France Pre harvest treatment: F annual grass Spraying Actively growing - a) 3.00 kg/ha (spot application) a) 2.16 kg as/ha (spot application) d Acceptable for wheat,

9 Page 9 of 48 Use- No Member state (s) Crop and/ or situation (crop destination / purpose of crop) Wheat, barley, triticale Except seeds treatments 4 France Orchards treatments: * all fruits species * Nuts * olives F G or I F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) broad-leaved Perennial annual grass annual grass broad-leaved Perennial Perennial 5 France Vineyards treatments: F annual grass broad-leaved Perennial 6 France Set-aside/Fallow F annual grass broad-leaved Perennial 7 France Devitalisation of vines and brambles method kind Spraying or hand-held Spraying or hand-held Overall spraying F - Spraying with tunnel spayer Application Application rate PHI (days) Max. number (min. kg, L product / ha g, kg as/ha Water interval between a) max. rate per L/ha applications) appl. a) per use b) max. total rate min / b) per crop/ season per crop/season max Timing / Growth stage of crop & season June-July <25% grain moisture of crop. Actively growing Spring and Summer Actively growing Spring and Summer Actively growing b) 3 max. Application per year per ha a) max. rate per appl. b) max. total rate per crop/season Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures triticaleand barley except seeds treatments a) 2.00 kg/ha a) 3.00 kg/ha a) 2.80 kg/ha (olive, kiwi, banana) a) 4.00 kg/ha (spot application) a) 3.00 kg/ha ha (spot application on olives) - a) 2.00 kg/ha a) 3.00 kg/ha a) 4.00 kg/ha (spot application) - a) 1.45 kg/ha a) 2.80 kg/ha a) 3.50 kg/ha Autumn - a) 4.00 kg/ha a) 1.44 kg as/ha a) 2.02 kg as/ha a) 2.02 kg as/ha a) 2.88 kg as/ha (spot application) a) 2.02 kg as/ha a) 1.44 kg as/ha a) 2.02 kg as/ha a) 2.88 kg as/ha (spot application) a) 1.04 kg as/ha a) 2.09 kg as/ha a) 2.52 kg as/ha a) 2.88 kg as/ha d except banana : 1 d ; olives: 7 d (on tree) ; pomme fruits : 28 d and kiwi: 90 d 21 d Not acceptable for oilseed rape (exceeding the LMR) Acceptable Acceptable - Not acceptable (use corresponding to Forestry pre-plant) - Acceptable (the use of recovery panels for devitalisation of vines is mandatory) 8 France Devitalisation of stumps, trees and shrubs F - Contact application wiping/brush Within 1 h after cutting - a) 0.17 kg/m² b) 0.17 kg/m² a) 120 g/m² b) 120 g/m² - - Acceptable

10 Page 10 of 48 Use- No Member state (s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) method kind 9 France Brush F Overall spraying and spot application Application Application rate PHI (days) Max. number (min. kg, L product / ha g, kg as/ha Water interval between a) max. rate per L/ha applications) appl. a) per use b) max. total rate min / b) per crop/ season per crop/season max Timing / Growth stage of crop & season a) max. rate per appl. b) max. total rate per crop/season Autumn - a) 5.00 kg/ha a) 3.60 kg as/ha Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures - Not acceptable (risk for aquatic organisms) 10 France Forestry Pre-plant F annual grass broad-leaved Overall spraying Shielded spray for spot or local treatments Actively growing - a) 1.45 kg/ha a) 2.80 kg/ha a) 1.04 kg as/ha a) 2.02 kg as/ha - Acceptable 11 France Forestry In crop Perennial annual grass broad-leaved Overall spraying Shielded spray for spot or local treatments Actively growing a) 5.00 kg/ha - a) 1.45 kg/ha a) 2.80 kg/ha a) 3.60 kg as/ha a) 1.04 kg as/ha a) 2.02 kg as/ha - Not acceptable (risk for operator for an application with lance) Acceptable Perennial a) 3.00 kg/ha a) 2.16 kg as/ha 12 France Pasture, Meadow, Grassland (renovation or selective control of invasive ) F annual grass broad-leaved Perennial Overall spraying Actively growing 3 a) 1.45 kg/ha a) 3.00 kg/ha a) 3.50 kg/ha a) 1.04 kg as/ha a) 2.09 kg as/ha a) 2.52 kg as/ha Acceptable for renovation only 13 France Alfalfa weeding F All spraying During the dormancy of the plant 1 a) 0.50 kg/ha b) 0.50 kg/ha a) 0.36 kg as/ha b) 0.36 kg as/ha Acceptable 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.

11 Page 11 of 48 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/ or, when relevant, the common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, ) 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

12 Page 12 of 48 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties The formulation ROUNDUP 720 (MON 79991) is water soluble granule (SG) formulation. All studies have been performed in accordance with the current requirements. The appearance of the formulation is granules with ivory cream color. It is not explosive and has no oxidizing properties. It has a self-ignition temperature > 400 C. In aqueous solution (1%), its ph is 4.25 at room temperature. Stability data indicate a shelf life of at least 2 years at ambient temperature (LDPE). Its technical characteristics are acceptable for a SG formulation. The formulation is not classified for the physico-chemical aspect Methods of analysis Analytical method for the formulation Analytical methods for the determination of active substance and relevant impurity (N-nitroso glyphosate) in the formulation are available and validated (a method for the determination of formaldehyde is provided but not considered validated by RMS). As the relevant impurity (formaldehyde) is by-product of the manufacturing process for glyphosate and as such cannot be formed in the non-aceptable limit by storage of the formulation, an analytical method for the determination of relevant impurity (formaldehyde) in the formulation is not necessary Analytical methods for residues Analytical methods are available in the monograph/this dossier and validated for the determination of residues of glyphosate in plants (all matrices except no group), soil, water (surface and drinking) and air. The active substance is neither toxic nor very toxic hence no analytical method is required for the determination of resides in biological fluids and tissues Mammalian Toxicology Endpoints used in risk assessment : ADI 0.3 mg kg bw/d EU agreed endpoint (2002) ARfD Not necessary EU agreed endpoint (2002) AOEL Acute Toxicity 0.2 mg/kg bw/d EU agreed endpoint (2002) 0.1 mg/kg bw/d Efsa 2015 ROUNDUP 720 containing 720 g/kg of glyphosate has a low acute oral and dermal toxicity, and is not skin and eye irritating, and it is not skin sensitizing Operator Exposure Operator exposure to orchards, vine, cereals, intercrops, forest and fallow destruction has been assessed with the BBA and/or UK POEM model against the AOEL of 0.2 mg/kg bw./d for glyphosate and with the new AOEL of 0.1 mg/kg/j (EFSA, 2015). Operator exposure to devitalisation of stumps trees and shrubs has been assessed with a biocide model. The dermal absorption value of glyphosate used for risk assessment is 1% for the non-diluted and diluted, based on an in vitro study on human skin realized on 3 similar preparations. Percutaneous absorption studies have been conducted with MON 79351, MON and MON The results for these preparations are, therefore, considered to be appropriate to use for estimating the potential dermal

13 Page 13 of 48 absorption of. The spray rates or dilutions of different formulations of glyphosate are equated to each other based on glyphosate per hectare. Therefore dilutions of each formulation will produce a similar amount of glyphosate to be sprayed per hectare. The amount of product used in dilutions will decrease as the loading of the formulation increases. For example, when needing to apply 360 g ai/ha you will require 1 liter/ha of a 360 loaded product, 0.75 l/ha of a 480 loaded product and 0.5kg/ha of a 720 loaded product. The concentration of glyphosate in the diluted product therefore remains the same across formulations. Therefore dilutions are comparable with regard to the amount of active substance for different formulation types. A dermal penetration factor of 3% was selected by the Rapporteur in the EU glyphosate Monograph. This value was derived from the results of several published studies, with varied outcomes, and should be considered as very conservative. The new data for these preparations are considered to be more relevant to the formulation considered in this dossier, ROUNDUP 720 (MON 79991), and have, therefore, been used in the exposure assessment. A dermal absorption value of 1% is conservative and applicable for. The risk for the operator using ROUNDUP 720 (MON 79991) on orchards, vine, cereals, intercrops, forest and fallow destruction is acceptable with a tractor mounted/trailed boom sprayer: hydraulic nozzles with a working coverall and without gloves during the mix/loading and application phases. The risk for the operator using ROUNDUP 720 (MON 79991) on orchards and vine is acceptable with a hand-held sprayer with a working coverall and with gloves during the mix/loading and application phases (finishing task, area treated 0.33 ha). The risk for the operator using ROUNDUP 720 (MON 79991) on forestry pre-plant is acceptable with a lance with a working coverall and with gloves during the mix/loading and application phases only for the lowest dose (2.8kg of product/ha). When the AOEL of 0.1 mg/kg bw/d is used in the risk assessment, the risk for the operator using MON (ROUNDUP 720) became unacceptable for the intended uses, on forestry pre plant at the dose of 2.8 kg/ha and on forestry crops at the dose of 3 kg/ha, wearing 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 The bystander exposure to orchard (worst case) represents 1.6% of glyphosate s AOEL a. The risk is considered acceptable Worker Exposure As ROUNDUP 720 (MON 79991) is an herbicide, entry of worker is not necessary. Therefore, no worker exposure assessment has been carried out Residues and Consumer Exposure Residues The data available are considered sufficient for risk assessment. An exceedance of the current MRLs for glyphosate as laid down in Reg. (EU) 396/2005 is not expected except for oilseed rape and grass for weed control Consumer exposure The chronic and the short-term intakes of glyphosate residues are unlikely to present a public health concern. As far as consumer health protection is concerned, France, zrms agrees with the authorization of the intended uses except on oilseed rape. The use on cultivated areas was considered acceptable only for inter-row applications with shielded sprayer avoiding contamination of crops.

14 Page 14 of 48 Mitigation measures Additionally in the framework of this dossier it is proposed to add a mitigation measure for intended uses in all orchards and grapevines. Indeed, considering that commodities can be present during treatment, the following mitigation measure is proposed to avoid any fruits contamination: Use application material or agricultural practices to avoid fruits contact with active substance or with soil treated with active substance. Summary for glyphosate The preparation MON 79991(ROUNDUP 720) is composed of glyphosate (ammonium salt) Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL complianc e Chronic risk for consumers identified? Acute risk for consumers identified? Orchards treatments * Nuts awaiting the two additional southern EU residue trials on hazelnuts and pistachio, in progress with mitigation measures No Orchards treatments * Citrus fruits awaiting two additional SEU residue trials on orange with mitigation measures No Orchards treatments * Pome fruits Orchards treatments * Stone fruits peach/apricot cherry awaiting the two additional southern EU residue trials on apricots and awaiting additionnal southern EU residue trials on plum with mitigation measures with mitigation measures No No No Except for wild fungi : avoid wild fungi harvest during the day following treatment. Orchards treatments * Olives PHI=7 days for olive harvest on tree with mitigation measures No Orchards treatments * Kiwi with mitigation measures No Orchards treatments * Banana Awaiting confirmatory trials PHI=1 days ; No Rapes (Vineyards with /

15 Page 15 of 48 Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL complianc e Chronic risk for consumers identified? Acute risk for consumers identified? treatment) mitigation measures Pre harvest treatment * Wheat including wheat for baking * Barley including barley for brewing No Pre harvest treatment * Oilseed rape (only France) NO Exceedanc e HR 11.6 mg/kg >10 mg/kg in force MRL No Alfalfa Awaiting SEU confirmatory trials No MRL No Pasture, meadow, grassland renovation Pasture, meadow, grassland weed selective control PRE- EMERGENCE treatment (Presowing and postsowing) Strawberry, vegetables, asparagus, sugar beet, cereals, nurseries, linseed, cotton, mustard, sunflower, soybean, oilseed rape, potato, maize / No / / / / No IN CROP treatment (Postplant treatment) Root/tuber vegetables (carrot, potato, sugar beet), fruiting vegetables (tomato, aubergine), legume vegetables (peas, awaiting Confirmatory southern residue trials on all intended crops. if shielded sprayers Inter-row Selective equipment No

16 Page 16 of 48 Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL complianc e Chronic risk for consumers identified? Acute risk for consumers identified? beans, broadbeans, frenchbeans), stem vegetables (artichoke, asparagus), cotton Post-plant treatment * Tomato Before planting or sowing / after harvest Arable crops * Horticultural crops (orchards and vegetables)t No (0) / / / No yes No Alfalfa Seed treatment Post-plant treatment * Tobacco Devitalisation of vines and brambles Devitalisation of stump Not alimentary crop ; uses not assessed Forestry Set-aside Brush Planted areas: pre-plant (lawn) application and ornemental Nurseries (flower, shrubs, ornementals, forestalls * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 For orange, additional data are required in post-registration to confirm that a no-residue situation occurs in the worst case application: 3 applications of 3.60 g/ha and a PHI of 21 days. For tree nuts, additional data are required in post-registration to confirm that a no-residue situation occurs in the

17 Page 17 of 48 worst case application: 3 applications of 3.60 g/ha and a PHI of 21 days. For apricot and plum, additional data are required in post-registration to confirm that a no-residue situation occurs in the worst case application: 3 applications of 3.60 g/ha and a PHI of 7 and 21 days. For banana, additional data are required in post-registration to confirm that a no-residue situation occurs in the worst case application: 3 applications of 3.60 g/ha and a PHI of 1 day. The effects of processing on the nature of glyphosate 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. 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 Environmental fate and behaviour The fate and behaviour in the environment of the formulation has been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review were used to calculate PECs for the active substance glyphosate and its metabolite AMPA 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 glyphosate and its metabolite AMPA metabolites in soil, surface water and groundwater has 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 review or agreed in the assessment based on new data provided. PEC soil and PECsw derived for the glyphosate and its metabolite AMPA are used for the eco-toxicological risk assessment. PECgw for glyphosate and AMPA do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO 221/2000[1].. Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses. 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 ecotoxicological risk assessment of the formulation was performed according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review for active substance and its 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. No risk assessment was conducted for birds and mammals for the following uses as no scenario was considered relevant for risk assessment: Use zrms opinion 20- Forestry (moistening, brushing, wiping) Local treatment, the risk is considered negligible Outcome acceptable 24- Devitalisation of stumps, trees and shrubs Local treatment, the risk is considered negligible acceptable 26- Dry field and drain edges, verges in rural roads No risk assessment provided by the notifier, the use MS issue is not intended in France 27- Irrigation and drainage canals No risk assessment provided by the notifier, the use MS issue is not intended in France [1] Guidance document on the assessment of the relevance of metabolites in groundwater of substance reguled under Council directive 94/414/EEC. Sanco/2000-rev10-final, 25 February 2003.

18 Page 18 of Hard surfaces: industrial sites, public communication pathways (parks, motorways, pavements, railways, airports), cemeteries and firebreaks Annual grasses, annual broadleaves/ biennials/ perennials 30- Drain, irrigation ditches and swampy areas (without water flow) 33- Home and Garden uses No risk assessment is relevant for these uses. The risk to birds and mammals is considered acceptable. No risk assessment provided by the notifier, the use is not intended in France No information was provided by the notifier (crop, rates, ) Not intended in France. acceptable MS issue MS issue For all other uses: The long-term risk to birds was not acceptable at the maximum rate intended (5L/ha). A new risk assessment was conducted and proposed by zrms at the maximum limit doses of glyphosate authorized for registrations in France : kg a.s/ha for intercrop uses (annual crops, post-harvest), kg a.s./ha for pre-harvest applications in cereals, kg a.s/ha for uses in orchards and vineyards (spot-treatment), - and kg a.s./ha for use on brambles. The risk for mammals are considered acceptable for all uses at the maximum dose of 3.6 kg a.s./ha. Based on the guidance documents, the risks for aquatic organisms are acceptable for the all intended uses when a buffer zone of 5 meters is applied except for devitalisation of vines and brambles. For these uses the risk assessment for aquatic organisms is not finalized (step 2). Member States should ensure that the conditions of authorisation include risk mitigation measures, where appropriate. Please note that due to French regulation [1], the use of recovery panels for devitalisation of vines is mandatory. Since such material is expected to significantly reduce surface water contamination due to drift, applications of MON (ROUNDUP 720) on this specific use is therefore considered as acceptable for FR. Based on the guidance documents, the risks for bees, non-target arthropods, earthworms and other soil macroorganisms, micro-organisms and non-target plants are acceptable for the intended uses. For non-target plants, the risks are acceptable when a buffer zone of 5 meters is applied Efficacy The product complies with the Uniform Principles. Considering the data submitted: The efficacy of ROUNDUP 720 (MON 79991) is considered as satisfying for all uses. The selectivity of ROUNDUP 720 (MON 79991) is considered as satisfying. The risk of negative impact (yield, quality, transformation processes, propagation, succeeding crops and adjacent crops) is considered as acceptable. However, in the absence of data on the impact on production of cereal seeds, the preparation cannot be used on seed-grain. Considering all the cases of resistance to glyphosate in the world, the applicant must put in place monitoring for cases of resistance in, especially Lolium sp., Conyza sp. and Ambrosia artemisiifolia. Any new data that may modify the risk must be communicated to the authorities. 3.2 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 [1] Journal Officiel du 8 octobre 2004, Avis à tous les détenteurs d autorisations de mise sur le marché pour des spécialités commerciales à base de glyphosate (ou N phosphonométhyl glycine)

19 Page 19 of 48 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 The applicant should put in place a monitoring of resistance cases on, especially on: - rye grass (Lolium multiflorum, Lolium perenne et Lolium rigidum), - fleabanes (Conyza sp.), - common ragweed (Ambrosia artemisiifolia). All new data (that may modify the risk linked to resistance) should be communicated to the authorities Post-authorisation data requirements The French Decision requests the submission of post-authorisation confirmatory pieces of information within 24 months regarding: - Confirmatory southern residues trials on orange, nuts, apricot and plum ; - Confirmatory southern and northern residues trials in inter-row on vegetable; - Confirmatory residues trials on banana. - Confirmatory southern and northern residues trials on wine grape Label amendments (see label in Appendix 2): 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.

20 Page 20 of 48 Appendix 1 Copy of the French Decision

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