CENTURION 240 EC Page 1 of 30. REGISTRATION REPORT Part A. Risk Management. Product name: CENTURION 240 EC Active Substance: Clethodim, 240 g/l

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1 Page 1 of 30 REGISTRATION REPORT Risk Management Product name: Active Substance: Clethodim, 240 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (Extension of use) Applicant: Arysta LifeScience S.A.S

2 Page 2 of 30 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 Therefore, only part Environmental fate and behaviour is modified for the uses described under point 2.3. The other summaries were identical to the summaries of the initial assessment for a larger number of uses (dossier , , ).The mitigation measures are presented for the uses of this application only 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 Data gaps 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... 30

3 Page 3 of 30 PART A Risk Management The company Arysta LifeScience S.A.S. has requested marketing authorisation in France for the product, containing 240 g/l clethodim for use as an herbicide on various crops. 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 review. It also includes assessment of data and information relating to CENTURION 240 EC where that data have not been considered in the EU review process. Otherwise assessments for the safe use of have been made using endpoints agreed in the EU review of clethodim. 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 Arysta LifeScience 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 label extension of this product in France and in other MSs of the Southern zone (dossier ). This dossier is a resubmission following an initial assessment that could not be finalised (dossier , and ) for the risk to groundwaters from metabolite trans-3-chloroacryloc acid. 1.2 Active substance approval Clethodim 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) No 87/2012 of 1 February 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clethodim. Specific provisions of regulation 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 clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 December 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures. The Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards:

4 Page 4 of 30 the soil and groundwater exposure assessments, the residue definition for risk assessment. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May An EFSA conclusion is available (EFSA Journal 2011;9(10):2417). A Review Report is available (SANCO/13456/210 final). 1.3 Regulatory Approach The present application (dossier ) 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 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 3 days; - unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is 5 m; - unless formally stated in the product authorisation, the minimum reentry delay is 6 hours for field uses and 8 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 assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/ and French regulation. 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) No546/2011 5, and are expressed as acceptable or unacceptable in accordance with those criteria. The decision, as duplicated 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, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 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

5 Page 5 of Letter(s) of Access Not necessary: the applicant has provided sufficient data to show that access is not required. 2 DETAILS OF THE AUTHORISATION 2.1 Product Identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) Herbicide Arysta LifeScience S.A.S. Clethodim 240 g/l EC Packaging HDPE-f (250 ml, 500 ml, 1 L, 3 L, 5 L, 10 L, 20 L) 2.2 Classification and Labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June 2015 (For information: Xn, N, R43, R65, R67, R 51/53) Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Aspiration toxicity category 1 Skin sensitisation category 1 Specific target organ toxicity after single exposure category 3 Environmental hazards Aquatic chronic 2 Hazard pictograms Signal word Danger Hazard statements H304 May be fatal if swallowed and enters airways H317 May cause an allergic skin reaction

6 Page 6 of 30 H336 H411 May cause drowsiness or dizziness Toxic to aquatic life with long lasting effects Precautionary statements For the P phrases, refer to the extant legislation 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 1 SPe 1 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 groundwater do not apply this or any other product containing clethodim more than once every other year on carrot, parsnip, horseradish at the application rate of 240 g/ha. To protect groundwater do not apply this or any other product containing clethodim more than once every other year on beetroot at the application rate of 300 g/ha. SPe 3 To protect aquatic organisms, respect an unsprayed buffer zone of 5 metres to surface water bodies 6 SPe 3 To protect non-target plants respect an unsprayed buffer zone of: - 20 m buffer distance to non-agricultural land for use on beet root 300 g as/ha, - 20 m buffer distance to non-agricultural land for use on parsnip, horseradish, carrot at 240 g as/ha, - 5 m buffer distance to non-agricultural land for use on beetroot, carrot, parsnip, horseradish at 120 g as/ha Other phrases linked to the preparation Wear suitable personal protective equipment 7 : refer to the Decision in Appendix 1 for the details Re-entry period 8 : 48 hours Pre-harvest interval 9 : - Carrot, parsnip, horseradish : 40 days - Beetroot : 60 days 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.

7 Page 7 of 30 Other mitigation measures: - It is recommended not to store the formulation more than 12 months at ambient temperature. The label may include the following recommendations: - To reduce the risk on adjacent crops of monocotyledonous type, it is advisable to leave a strip of 3 m untreated. 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, evaluated and concluded as safe uses by France as zrms. 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 clethodim Formulation type: Conc. of as 1: emulsifiable concentrate EC 240 g/l Applicant: Zone(s): Arysta LifeScience S.A.S Southern professional use non professional use Verified by MS: yes Crop and/ or situation (a) Zone F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment PHI (days) (l) Remarks: (m) Type (d-f) Conc. of as (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) g as/hl min max water L/ha min max g as/ha min max Beetroot France F Annual grasses EC Clethodim 240 g/l Overall BBCH ,5 L /ha Beetroot France F Perennials EC Clethodim 240 g/l Carrot France F Annual grasses EC Clethodim 240 g/l Overall BBCH once every other year Overall BBCH ,25 L /ha To protect groundwater do not apply this or any other product containing clethodim more than once every other year on beetroot at the application rate of 300 g/ha ,5 L /ha

9 Page 9 of 30 Carrot France F Perennial grasses EC Clethodim 240 g/l Overall BBCH once every other year L /ha To protect groundwater do not apply this or any other product containing clethodim more than once every other year on carrot at the application rate of 240 g/ha. Horseradish France F Annual grasses EC Clethodim 240 g/l Overall BBCH ,5 L /ha Horseradish France F Perennial grasses EC Clethodim 240 g/l Overall BBCH once every other year L /ha To protect groundwater do not apply this or any other product containing clethodim more than once every other year on horseradish at the application rate of 240 g/ha. Parsnip France F Annual grasses EC Clethodim 240 g/l Overall BBCH ,5 L /ha Parsnip France F Perennial grasses EC Clethodim 240 g/l Overall BBCH once every other year L /ha To protect groundwater do not apply this or any other product containing clethodim more than once every other year on parsnip at the application rate of 240 g/ha. 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

10 Page 10 of 30 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles This dossier is a resubmission following an initial assessment that could not be finalised (dossiers , , ) for the risk to ground waters from metabolite trans-3-chloroacryloc acid. Therefore, only part Environmental fate and behaviour is modified for the uses described under point 2.3. The other summaries were identical to the summaries of the initial assessment for a larger number of uses (dossier , , ).The mitigation measures are presented for the uses of this application only Physical and chemical properties The formulation is an emulsion concentrate. All studies have been performed in accordance with the current requirements. The appearance of the formulation is that of amber liquid, with intensive petrol like odour. It is not explosive and has no oxidizing properties. It has a self-ignition temperature of 428 C and a flash point of 66.4 C. In aqueous solution of 1%, its ph is 4.6 at 21 C. Stability data indicate a shelf life of 12 months at ambient temperature in HDPE, consequently, HDPE- Fluorinated packaging is considered compatible with the formulation. The 2-year shelf life study at ambient temperature shows a decrease in active substance content of 13.8%, consequently, it is recommended not to store the formulation more than 12 months at ambient temperature. The formulation technical characteristics are acceptable for an emulsion concentrate formulation, but show that formulation should be shaken during use, in compliance with good agricultural practices recommendations Methods of analysis Analytical methods for the determination of active substance and relevant impurity in the formulation are available and validated. As relevant impurity (toluene) is a by-product of the manufacturing process for clethodim and as such cannot be formed by storage of the formulation, an analytical method for the determination of relevant impurities in the formulation is not necessary. Analytical methods are available in the monograph/this dossier and validated for the determination of residues of clethodim in plants, soil, water (surface and drinking) and air. As no residue definition in food of animal origin is set, no method for the determination of clethodim residues in animal products is required. To update the dossier, validated confirmation methods are required for the determination of clethodim sulfone residue in high oil and high water content plants and of clethodim oxazole sulfone residue in soil. 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.

11 Page 11 of Mammalian Toxicology The plant protection product is the same as the one assessed for the inclusion of the active substance in Annex I of Directive 91/414/EC. is the second trade name of SELECT. Several product name have been identified, ARY ; TM 20016; Select 2EC-H and Select 2.0. ARY represents the new formulation of. Acute toxicity Toxicological data on the formulation Select 2.0EC (acute oral, dermal and inhalation, skin and eye irritation and skin sensitization (Buhler 9 applications) studies) have been already evaluated during the peer review of the active substance and during the first approval of the preparation in France (Authorization N : ). Based on the results of these studies, was not classified for acute toxicity by oral, dermal and inhalation route. The formulation was found to be irritating to eyes. The preparation was not skin sensitizer. The submitted skin irritation study was not considered acceptable, therefore the preparation was considered skin irritant by calculation (refer to B ACUTE TOXICITY. Clethodim- DAR-04_vol 3_B6.). New acute toxicity studies on the formulation ARY were performed (acute oral and dermal, skin and eye irritation and ski sensitization (LLNA) studies). Based on the results of the new acute toxicity studies, CENTURION 240 EC is not classified for acute toxicity by oral and dermal route. The formulation is not irritating to eyes and skin. The formulation ARY is skin sensitizer. Dermal absorption The percutaneous absorption of clethodim on the preparation had been already evaluated during the peer review 10 of clethodim. The agreed dermal absorptions are 15% for the undiluted formulation and 42% for the spray dilution, based on an in vivo dermal absorption study in rats. Exposure assessments The Plant Protection Product is an emulsifiable concentrate (EC) containing 240 g/l of clethodim.it is intended to be used as an herbicide on several crops. The worst application rate is 360 g/ha for artichoke and chard which covers all other crops by risk envelop. These critical use patterns have been defined following evaluation of the individual GAPs for each crop in each relevant Member State as detailed in Appendix 2 of Part B section 3. Use information relevant to operator, bystander and worker exposure is summarised in Table below: 10 Conclusion on the peer review of the pesticide risk assessment of the active substance clethodim. EFSA Journal 2011;9(10):2417 [95 pp.].

12 Page 12 of 30 Summary of critical use patterns (i.e. worst case) Application rate Spray dilution Crop (g as/ha) (L/ha) artichoke Application equipment Tractor mounted/ trailed boom sprayer, hydraulic nozzle + Hand-held sprayer: hydraulic nozzles (applicant request) 1 1 According to the French agricultural practices, the use of hand-held manual spraying in artichoke is not a usual practice; however, it was modelling as it was requested by the applicant. Operator exposure For tractor mounted/trailed boom sprayer: Operator exposure to using the tractor mounted/trailed boom sprayer has been calculated according to BBA model taking into account a protection factor of 90% for the working coverall. Based on this calculation, the operator exposure to using the tractor mounted/trailed boom sprayer is acceptable when wearing working coverall but no gloves. For hand-held sprayer: Operator exposure to using the hand-held sprayer has been calculated according to UK POEM model taking into account a protection factor of 90% for the working coverall. Based on this calculation, the operator exposure to using the hand-held sprayer is not acceptable even if PPE are worn. Bystander exposure The Bystander exposure to has been calculated according to the EUROPOEM II model. Based on this calculation, it is concluded that there is no undue risk to the bystander after short-term incidental exposure. Worker exposure The formulation CENTURION 240 is an herbicide applied to weeds on crops that do not require entering treated areas shortly after application. Therefore the estimation of worker exposure is considered irrelevant as no exposure is expected Residues and Consumer Exposure Residues (Part B, Section 4, Points 8.1 to 8.9) Primary crop metabolism of clethodim was sufficiently investigated to define residue for enforcement and risk assessment in the crops belonging to the root and tuber and pulses and oilseed groups. A new metabolism study on spinach was submitted. 3-chloroallyl glucoside appears as a main component of residue in this crop and should then be included in residue definition for risk assessment. No toxicological data on this metabolite is available, thus, no residue definition in a third group of crops could be proposed. Therefore, uses on

13 Page 13 of 30 chards, rice, alfalfa, celery (stem and leaves), parsley, head cabbage and artichoke could not be considered as fully supported. Regarding the magnitude of residues in fresh beans with pods, fresh peas with pods, carrot, parsnip, horseradish, beetroots and peanuts, a sufficient number of residue trials are available to support all the intended GAPs in France. For fresh beans without pods, fresh peas without pods, lupines, dry beans, a fall back cgaps of 1 application of 120 g/ha performed at BBCH 49 the latest was proposed instead of a 30-day PHI. These data allowed to estimate the expected residue concentrations in the relevant plant commodities, and to confirm that no MRL exceedance will result from intended uses in France. However, in order to comply with data requirements on stability of active substance, confirmatory data on stability covering the storage duration of samples should be submitted in post registration (fatty matrices for at least 9 months). Considering the residue levels in crops, there is no need to investigate the effect of industrial and/or household processing. However, since some crops are consumed after processing, a confirmatory study on the nature of residues in hydrolytic conditions should be submitted post authorization. Residues in succeeding crops have been sufficiently investigated; 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. Consumer exposure (Part B, Section 4, Point 8.10) The toxicological profile of clethodim was evaluated at EU level, which resulted in the proposal of an ADI (0.16 mg/kg). The setting of an ARfD was not deemed necessary. Chronic consumer exposure resulting from the uses proposed in the framework of this application was calculated. Based on EFSA PRIMo (rev2), chronic and acute exposures were considered as acceptable for all groups of consumers. Mitigation measures (Part B, Section 4, Point 8.11) According to available data, no specific mitigation measures should apply.

14 Page 14 of 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 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 clethodim and its 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 or with MED-Rice model, and the endpoints established in the EU review or agreed in the assessment based on new data provided. The exposure assessment of non-target organisms in soil and surface water is covered by the extension of uses previously assessed (i.e.: The results for PEC soil and PECsw for the active substance and its metabolites are used for the eco-toxicological risk assessment.) The risk assessment of transfer of clethodim, clethodim sulfoxide, clethodim sulfone and clethodim oxazole sulfone to groundwater is covered by the extension of uses previously assessed. (i.e.: For the intended uses on crops other than rice, PECgw for clethodim and 2-[3-chloroallyloxyimino]butanoic acid do not exceed the trigger of 0.1 µg/l. PECgw of the metabolites clethodim sulfoxide (max µg/l), clethodim sulfone (max µg/l) and clethodim oxazole sulfone (max µg/l) are higher than 0.1 µg/l however these metabolites are not relevant according to guidance document SANCO/221/2000.) The risk assessment for the transfer of photolytic metabolites trans-3-chloroacrylic acid and 2-[3- chloroallyloxyimino]butanoic acid to groundwater is reassessed in this resubmission dossier based on confirmative data validated by the RMS of the active substance. The PEC of metabolites trans-3-chloroacrylic acid and 2-[3-chloroallyloxyimino]butanoic acid in 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. PECgw for the metabolite 2-[3-chloroallyloxyimino]butanoic acid do not exceed the trigger of 0.1 µg/l for all intended uses. PECgw for the metabolite trans-3-chloroacrylic acid do not exceed 0.1 µg/l for the uses on beetroot and carrot when clethodim is applied at the dose of 120 g/ha. When clethodim is applied at the dose of 300 g/ha on beetroot and 240 g/ha on carrot, PECgw for the metabolite trans-3-chloroacrylic acid do not exceed 0.1 µg/l when the preparation is applied every other year. 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.

15 Page 15 of 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 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. Based on the guidance documents, the risks for birds, mammals, bees and other non-target arthropods, earthworms and other soil macro-organisms, micro-organisms are acceptable for the intended uses but mitigation measures are recommended: For aquatic organisms, the risks are acceptable with: - 5 m buffer distance for use on beet root at 120 or 300 g as/ha, - 5 m buffer distance for use on carrot, parnships, horseradish at 120 or 240 g as/ha, For terrestrial non-target plants, the risks are acceptable with: - 20 m buffer distance for use on beet root at 300 g as/ha, - 20 m buffer distance for use on carrot, parsnips, horseradish at 240 g as/ha, - 5 m buffer distance for use on beet root, carrot, parsnips, horseradish at 120 g as/ha Efficacy The product complies with the Uniform Principles. Considering the data submitted: According to presented trials, efficacy of the tested preparation in addition with oil was mainly similar than other products tested. Consequently efficacy is considered as demonstrated on pea and bean, carrot, rice, artichoke and fescue (for seed production). No data was provided on other claimed crops. However, efficacy observed on carrot can be extrapolated to parsnips, horseradish, parsley, and celery. Results observed on pea can be extrapolated to lupine. Results observed on oilseed rape can be extrapolated to tobacco. In addition, use on potatoes is already registered in France, so efficacy can be extrapolated to sweet potato. Sugarbeet is also already registered in France so efficacy can be extrapolated to red-beet. No extrapolation is possible to cabbage however because selectivity trials are presented in this document on this crop, efficacy on this crop can be considered acceptable (according to good efficacy observed on other crops). In addition, is already registered in France on soybean at 0.75 L/ha, so efficacy can be extrapolated to peanut. The dose authorized will be the same as claimed for CENTURION R (120 g s.a./ha). No data was provided on vegetables for seed production; however, these uses are supported by FNAMS 11. Consequently only selectivity trials were provided. 11 Fédération nationale des agriculteurs multiplicateurs de semences

16 Page 16 of 30 - The selectivity of is very good on artichoke, carrot, cabbage and rice, whatever the dose rate. On pea and bean, some symptoms can be observed. On fescue and vegetables for propagation purposes, please refer to FNAMS for more information. On other crops, no selectivity data was provided. However, selectivity results observed on carrot can be extrapolated to parsnips, horseradish, parsley, and celery. Results observed on pea can be extrapolated on lupine. Sugarbeet is already registered in France so selectivity can be extrapolated to red-beet. On tobacco, selectivity should be tested before application. - The risk of negative impact (yield, quality, transformation processes, propagation, succeeding crops, adjacent crops) is considered as negligible, - The risk of resistance development or appearance is considered as moderate. Uses Claimed dose Active substance (g a.i./ha) Number of application Comments (efficacy) *Carrot *weeding (annuals) 0,5 L/ha 120 g/ha 1 Acceptable * Carrot *Weeding (perennials) 1 L/ha 240 g/ha 1 Acceptable Parsnips*Weeding (annuals) 0,5 L/ha 120 g/ha 1 Acceptable (extrapolation from carrot) Parsnips*Weeding (perennials) 1 L/ha 240 g/ha 1 Acceptable (extrapolation from carrot) Horseradish*weeding (annuals) 0,5 L/ha 120 g/ha 1 Acceptable (extrapolation from carrot) Horseradish*weeding (perennials) 1 L/ha 240 g/ha 1 Acceptable (extrapolation from carrot) Acceptable (extrapolation from *Red-beet * weeding (annuals) 0,75 L/ha 0,5 L/ha 180 g/ha 120 g/ha 1 sugarbeet and harmonization to authorized dose with CENTURION R) Acceptable (extrapolation from *Red-beet * weeding (perennials) 2 L/ha 1,25 L/ha 480 g/ha 300 g/ha 1 sugarbeet and harmonization to authorized dose with CENTURION R) 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 No information stated.

17 Page 17 of Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Post-authorisation monitoring No further information is required Post-authorisation data requirements The French decision requests the submission of post-authorisation confirmatory pieces of information within 24 months regarding: - Validated confirmation methods for the determination of clethodim sulfone residue in high oil and high water content plants. - Validated confirmation method for the determination of clethodim oxazole sulfone residue in soil. - A confirmatory study on the nature of residues in hydrolytic conditions Data gaps 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.

18 Page 18 of 30 Appendix 1 Copy of the French decision

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25 Page 25 of 30 Appendix 2 Copy of the draft product label as proposed by the applicant

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30 Page 30 of 30 Appendix 3 Letter(s) of Access Not applicable