KEYNOTE ( ) Page 1 of 31. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 31 REGISTRATION REPORT Part A Risk Management Product code: Product name(s): KEYNOTE Active Substances : 130 g/l Prothioconazole 65 g/l Bixafen 65 g/l Fluopyram COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation)

2 Page 2 of 31 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 APPENDIX 3 LETTER(S) OF ACCESS... 31

3 Page 3 of 31 PART A Risk Management The company BAYER S.A.S has requested marketing authorisation in France for the product KEYNOTE ( ), containing 130 g/l prothioconazole, 65 g/l bixafen and 65 g/l fluopyram for use as a fungicide. 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 prothioconazole, bixafen and fluopyram. 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 BAYER S.A.S s application to market KEYNOTE ( ) in France as a fungicide (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 Prothioconazole Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. Specific provisions of Regulation (EU) No 540/2011 were as follows : Part A Only uses as fungicide may be authorised. Part B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator safety in spray applications. Conditions of use shall include adequate protective measures, the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of:

4 Page 4 of 31 information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the entry into force of the Directive of inclusion. An EFSA conclusion is available (EFSA Scientific Report (2007) 106, 1-98). A Review Report is available (SANCO/3923 /07 - final, 10 December 2007). Bixafen Commission Implementing Regulation (EU) No 350/2013 of 17 April 2013 approving the active substance bixafen, 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 350/2013 were as follows : In this overall assessment Member States shall pay particular attention to: (a) the residues of bixafen and of its metabolites in rotational crops; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the risk to aquatic organisms; (d) the risk to soil and sediment-dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate. An EFSA conclusion is available (EFSA Journal (2012); 10(11):2917). A Review Report is available (SANCO/10357/2013 rev 3, 15 March 2013). Fluopyram Commission Implementing Regulation (EU) No 802/2013 of 22 August 2013 approving the active substance fluopyram, 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 802/2013 were as follows : In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the long-term risk to insectivorous birds; (2) the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals. The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.

5 Page 5 of 31 An EFSA conclusion is available (EFSA Journal 2013; 11(1):3052). A Review Report is available (SANCO/11456/2013 rev 2, 16 July 2013). 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 applicant 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

6 Page 6 of 31 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, 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 is the owner of the actives substances. 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) Packaging Fungicide BAYER S.A.S 130 g/l Prothioconazole 65 g/l Bixafen 65 g/l Fluopyram Emulsifiable Concentrate (EC) HDPE/PA or HDPE/EVOH container (1, 3, 5, 10 and 15L). 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Acute toxicity (oral), Category 4, Serious eye damage/eye irritation, Category 1 Sensitisation Skin, Category 1 Specific target organ toxicity Single exposure, Category 3 Reproductive toxicity, Category 2 (d) Environmental hazards Hazard pictograms Aquatic Chronic, Category 1 Signal word Danger, Warning Hazard statements H302 Harmful if swallowed H317 May cause an allergic skin reaction

7 Page 7 of 31 Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) H318 Causes serious eye damages H335 May cause respiratory irritation H361d Suspected of damaging the unborn child H410 Very toxic to aquatic life with long lasting effects For the P phrases, refer to the extant legislation 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 Spe3 Spa 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 aquatic organisms, respect an unsprayed buffer zone of 5 metres 8 with an unsprayed vegetated buffer zone of 5 metres to surface water bodies. - To avoid the build-up of resistance do not apply KEYNOTE more than once per crop on wheat, triticale, rye and spelt. - To best manage the risks of resistance, it is recommended to follow the use limitations for each chemical group recommended in the official French guidance 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 : 48 hours Pre-harvest interval 12 : F- Application must be made at growth stage BBCH 61 at the latest. Other mitigation measures: - Store the preparation away from light. The label may include the following recommendations: -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] Note commune INRA, ANSES, ARVALIS Institut du végétal, pour la gestion de la résistances aux fongicides utilisés pour lutter contre les maladies des céréales à paille, available at 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 PPP (product name/code) ) active substance 1 bixafen active substance 2 fluopyram active substance prothioconazole Formulation type: Conc. of as 1: Conc. of as 2: Conc. of as 3: GAP rev. 01, date: EC 65 g/l 65 g/l 130 g/l Applicant: Zone(s): Bayer S.A.S. Southern zone/eu professional use non professional use Verified by MS: yes 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) 1 France Wheat F PSDCHE, SEPTTR, LEPTNO, PUCCRT, PUCCST, ERYSGT PYRNTR, MICCNI, FUSASP 2 France Rye F ERYSGS, RHYNSE, PUCCRR, PSDCHE 3 France Triticale F RHYNSE, SEPTTR, LEPTNO, PUCCRT, ERYSGR, MICCNI, FUSASP 4 France Spelt F RHYNSE, SEPTTR, LEPTNO, PUCCRT, ERYSGR, MICCNI, FUSASP Method / Kind Overall spray Overall spray Overall spray Overall spray Application Application rate PHI Timing / Growth Max. number kg, L product / g, kg as/ha (days) Water L/ha stage of crop & (min. interval ha season between a) max. rate per a) max. rate per appl. applications) appl. b) max. total rate per min / max a) per use b) max. total rate crop/season b) per crop/ per crop/season season BBCH a) 1.5 b) 1.5 BBCH a) 1.5 b) 1.5 BBCH a) 1.5 b) 1.5 BBCH a) 1.5 b) 1.5 a) b) a) b) a) b) a) b) Remarks: F Acceptable F Acceptable F Acceptable F Acceptable

9 Page 9 of 31 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 31 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 a clear liquid, light brown with rancid odour, emulsifiable concentrate. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. It is not explosive and has no oxidizing properties. The product has a flash point of 148 C. It has a self-ignition temperature of 360 C. In aqueous solution (1%), it has a ph value of 5.9 at ambient temperature. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 C and 14 days at 54 C, neither the active ingredient content nor the technical properties were changed. The stability data indicate a shelf life of at least 2 years at ambient temperature when stored in HDPE/EVOH and HDPE/PA. Determination of the content of prothioconazole desthio in the preparation has been performed twice. One time, the content was higher than % w/w (maximal acceptable limit in the preparation), but the second time the content of prothioconazole-desthio was finally determined to be below the acceptable value of %. An explanation has been provided by the applicant and was found acceptable. Some samples tested during the stability studies were exposed to sunlight. As prothioconazole is sensitive to light (DR 50 < 2 days) and is degrading into prothioconazole desthio, this may explain why content of the relevant impurity prothioconazole desthio in the formulation exceeds the acceptable limit. Therefore, as recommended by the applicant, the preparation must be stored away from light. Its technical characteristics are acceptable for an emulsifiable concentrate formulation Methods of analysis Analytical methods for the determination of active substances and relevant impurities in the formulation are available and validated. Analytical methods are available in the monograph and in this dossier and validated for the determination of residues of prothioconazole, bixafen and fluopyram in plants (dry commodities), 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. The metabolite prothioconazole desthio is toxic (T), therefore an analytical method is available in this dossier and validated for the determination of residues of prothioconazole desthio in tissues and body fluids. Other data gaps in EFSA conclusion and in the review reports: Prothioconazole desthio (EFSA Scientific Report (2007) 106, 1-98) - A revised specification is required to include a proposed maximum limit for the relevant impurity prothioconazole-desthio and to correct the naming of the impurities with regard to R and S isomers (relevant for all uses evaluated, data gap identified by EFSA February Refer to chapter 1). - Spectra for the relevant impurity prothioconazole-deschloro (relevant for all uses evaluated, data gap identified by EFSA April 2007; refer to chapter 1) Mammalian Toxicology Endpoints used in risk assessment Active Substance: Bixafen ADI 0.02 mg kg bw/d Efsa (2012)

11 Page 11 of 31 ARfD AOEL Dermal absorption 0.2 mg/kg bw/d 0.13 mg/kg bw/d Default values according to guidance on dermal absorption (Efsa 2012): Concentrate Spray dilution (used in formulation) (used in formulation) 65 g/l 0.24 g/l Dermal absorption endpoints % Active Substance: Fluopyram ADI ARfD AOEL Dermal absorption mg kg bw/d 0.5 mg/kg bw Efsa (2013) 0.05 mg/kg bw/d Default values according to guidance on dermal absorption (Efsa 2012): Concentrate Spray dilution (used in formulation) (used in formulation) 65 g/l 0.24 g/l Dermal absorption endpoints % Active Substance: Prothioconazole ADI ARfD AOEL Dermal absorption 0.01 mg kg bw/d 0.2 mg/kg bw/d UE (2008) 0.2 mg/kg bw/d Default values according to guidance on dermal absorption (Efsa 2012): Concentrate Spray dilution (used in formulation) (used in formulation) 130 g/l 0.5 g/l Dermal absorption endpoints % Active Substance: Desthio-prothioconazole ADI 0.01 mg kg bw/d EU agreed endpoint ARfD 0.01 mg/kg bw/d (EFSA Scientific Report AOEL 0.01 mg/kg bw/d (2007) 106, 1-98, Conclusion on the peer review of prothioconazole) Dermal Based on an in vivo monkey study performed on a similar formulation: absorption Diluted formulation Concentrate (480g/L) (1.61g/l) In vitro (monkey) % Concentrate (used in formulation) 130 g/l Spray dilution (used in formulation) 0.5 g/l Dermal absorption endpoints % NB: It has been found that prothioconazole in diluted solutions can convert to prothioconazole-desthio during the drying process on clothing, skin or on certain plant surfaces. The conversion product, prothioconazole-desthio is known to have an embryotoxic potential in experimental animals. Therefore, three operator exposure studies were conducted to determine the exposure to prothioconazole as well as to prothioconazole-desthio under real use conditions (Maasfeld et al. (see 7.5.3)). However, given the limitations of the field studies it has been considered more appropriate to estimate operator exposure using the German BBA model considering 100% of conversion. This corresponds to a conservative and precautionary approach Acute Toxicity

12 Page 12 of 31 containing 65 g/l of bixafen, 65 g/l of fluropyram, 130 g/l of prothioconazole and 130 g/l of desthio-prothioconazole is classified for acute toxicity by oral route, has a low toxicity in respect to dermal toxicity, and inhalation. It is not irritating to the rabbit skin, but is irritating to the rabbit eye and is a skin sensitizer Operator Exposure Summary of critical use patterns (worst cases): Crop F/G 13 Equipment Application rate L product/ha (g as/ha) Spray dilution (L/ha) Model Cereals F Tractormounted boom sprayer 1.5 L/ha (102.6 g bixafen/ha, g fluopyram, /ha, 201 g prothioconazole/ha, and 201 g desthioprothioconazole/ha) BBA Considering proposed uses, operator systemic exposure was estimated using the German BBA model: Crop Equipment PPE and/or working coverall % AOEL Bixafen % AOEL Fluopyram % AOEL Prothioconazol e % AOEL Desthioprothioconazol e Cereals Tractormounted boom sprayer 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 KEYNOTE ( ) 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 0.44% of the AOEL of bixafen, 1.13% of the AOEL of fluopyram, 0.56% of the AOEL of prothioconazole and 3.58% of the AOEL of desthio-prothioconazole. It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to Resident Exposure Residential exposure was assessed according to Martin et Al., Exposure is estimated to < 1% of the AOEL of bixafen, fluopyram, prothioconazole and desthio-prothioconazole. It is concluded that there is no unacceptable risk to the resident exposed to Worker Exposure Workers may have to enter treated areas after treatment for crop inspection activities. Therefore, estimation of worker exposure was calculated according to EUROPOEM II. Exposure is estimated to 3% of the AOEL of bixafen, 13 Open field or glasshouse

13 Page 13 of % of the AOEL of fluopyram, 3.8% of the AOEL of prothioconazole and 20% of the AOEL of desthioprothioconazole. It is concluded that without taking into account a re-entry period, there is no unacceptable risk anticipated for workers not wearing PPE /wearing a working coverall and gloves, when re-entering crops treated with. For details of personal protective equipment for workers, refer to the Decision in Appendix Relevance of metabolites Refined risk assessment for water consumers according to French monitoring data : non relevant metabolite M44: According to French monitoring data in groundwater (see Predicted Environmental Concentration in groundwater), M44 metabolite has a concentration > 0.1 µg/l. According to the guidance document SANCO/221/ , and taking into account the provided toxicological data, this metabolite is not considered relevant. According to the guidance document, the Predicted Environmental Concentration in groundwater being > 0.75 µg/l for this metabolite (maximum value of µg/l), a risk assessment associated with drinking water consumption is carried out. The metabolite ADI is 0.3 mg/kg pc/j. Considering a mean bodyweight of 60kg and a 2L daily water consumption, the consumer exposure represents % of the metabolite ADI. Maximum level in Theoretical ingestion ADI Metabolite % ADI groundwater (µg/l) µg/day µg/kg bw/jour (mg/kg pc/j) Adult, 60 kg bw, 2L/day water consumption: M As a conclusion, it was not expected that M44 would represent a health hazard to the consumers Residues and Consumer Exposure The data available are considered sufficient for risk assessment. An exceedance of the current MRL for bixafen, prothioconazole and fluopyram as laid down in Reg. (EU) 396/2005 is not expected. The chronic and the short-term intakes of bixafen, prothioconazole and fluopyram residues are unlikely to present a public health concern. As far as consumer health protection is concerned, France agrees with the authorization of the intended uses. According to available data, no specific mitigation measures should apply. Data gaps No noticed data gaps. Summary of the evaluation The preparation is composed of bixafen, prothioconazole and fluopyram. Summary for bixafen Use- No.* Crop Plant metabolis m covered? Sufficient residue trials? PHI sufficie ntly support ed? Sample storage covered by stability data? MRL compliance Reg 834/2013 Chronic risk for consumers identified? Acute risk for consumers identified? Comments / Wheat, rye, triticale and spelt Yes Yes (14 NEU and 18 SEU) Yes Yes Yes No No - The effects of processing on the nature of bixafen 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. 14 Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council directive 91/414/EEC. Sanco/221/2000-rev4, 25 February 2003.

14 Page 14 of 31 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 prothioconazole Use- No. * Crop Plant metabolism covered? Sufficien t residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg 2016/67 and SANCO/1148 1/2014 Chronic risk for consumers identified? Acute risk for consum ers identifie d? Comments / Wheat, rye, triticale and spelt Yes Yes (15 NEU and 16 SEU) Yes Yes Yes No No The effects of processing on the nature of prothioconazole 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. Summary for fluopyram Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg 2015/1101 Chronic risk for consumers identified? Acute risk for consumers identified? Comments Wheat, rye, triticale and spelt Yes Yes (12 NEU and 8 SEU) Yes Yes Yes No No The effects of processing on the nature of fluopyram 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. MRLs in following crops have been proposed: 0.1 mg/kg for root and tuber vegetables and leafy crops; 0.01 mg/kg for cereals, oilseed crops and perennial crops; 0.01 mg/kg for fruits and fruiting vegetables. It is very unlikely that residues exceeding MRLs 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.

15 Page 15 of 31 Summary for Crop PHI for KEYNOTE proposed by applicant PHI/ Withholding period* sufficiently supported for bixafen prothioconazole Fluopyram PHI for KEYNOTE proposed by zrms zrms Comments (if different PHI proposed) Wheat, rye, triticale and spelt F** BBCH 61 Yes Yes Yes F** BBCH 61 NR: not relevant * Purpose of withholding period to be specified ** F: PHI is defined by the application stage at last treatment (time elapsing between last treatment and harvest of the crop) Environmental fate and behaviour The fate and behaviour in the environment of the formulation have 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 substances and their metabolites for the intended use patterns. In cases where deviations from the EU agreed endpoints were considered appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. The PEC of bixafen, prothioconazole, fluopyram 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 review or agreed in the assessment based on new data provided. PEC SOIL and PEC SW derived for the active substances and their metabolites are used for the eco-toxicological risk assessment, and mitigation measures are proposed. PEC GW for bixafen, prothioconazole, fluopyram and their metabolites do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO 221/ Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses. Based on vapour pressure, 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 Effects on Terrestrial Vertebrates The risk assessment for birds and mammals is carried out according to the EFSA Guidance Document on Risk Assessment for Birds and Mammals (2009) [1] and considering the EU agreed endpoints of bixafen, prothioconazole and fluopyram. The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk and 5 for long-term risk, indicating that the risk to birds and mammals [2] is acceptable following use of KEYNOTE ( ) according to the proposed use patterns. 15 [1] 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 European Food Safety Authority; Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA. EFSA journal 2009; 7(12):1438. [139 pp.]

16 Page 16 of Effects on Aquatic Species The risk assessment for aquatic organisms is carried out according to the Guidance Document on Aquatic Ecotoxicology (Sanco/3268/2001) and considering the EU agreed endpoints of bixafen, prothioconazole, fluopyram and data on the formulation. The TER for bixafen, prothioconazole and fluopyram exceed the relevant triggers, indicating that the risk to aquatic organisms is acceptable following use of according to the proposed use patterns with respect of a unsprayed vegetative buffer zone of 5 metres Effects on Bees and Other Arthropod Species Based on the guidance documents, the risks for bees and other non-target arthropods are acceptable for the intended uses Effects on Earthworms and Other Soil Macro-organisms The risk assessment for earthworms and other soil macro-organisms is carried out according to the Guidance Document on Terrestrial Ecotoxicology (Sanco/10329/2002) and considering the EU agreed endpoints of bixafen, prothioconazole, fluopyram, their metabolites and data on the formulation. The acute and chronic TER values for bixafen, prothioconazole, fluopyram, their metabolites and data on the formulation are greater than the triggers of 10 and 5 respectively, indicating that the risk to earthworms and other soil macro-organisms is acceptable according to the proposed use pattern Effects on Soil Non-target Micro-organisms The risk of to soil micro-organisms was evaluated by comparison of no-effect concentrations, derived from laboratory tests, with PEC S. The no effect levels exceed the relevant PEC S values, indicating that the risk to soil micro-organisms is acceptable following use of according to the proposed use pattern Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) The risk assessment for non-target plants is carried out according to the Guidance Document on Terrestrial Ecotoxicology (Sanco/10329/2002) and considering the endpoints of the formulation. The application of does not cause unacceptable effects on non-target terrestrial plants when applied at a maximum application rate of 1.5L formulation/ha Efficacy Considering the data submitted: The efficacy of is considered as satisfactory in the claimed conditions. The phytotoxicity of is considered as negligible in the claimed conditions. The risk of negative impact on yield, quality, transformation processes, propagation, non-target organisms, succeeding crops, adjacent crops is considered as negligible. The risk of resistance development or appearance is considered as moderate to high for bixafen and fluopyram and moderate for prothioconazole for the uses claimed because of septoria. Crop Target Application rate L/ha or kg/ha Spray volume L/ha Number of applications Method and timing Efficacy conclusion [2] from direct dietary exposure, drinking water and secondary poisoning.

17 Page 17 of 31 Wheat Rye triticale Spelt Oculimacula species Mycosphaerella graminis Leptosphaeria nodorum Puccinia recondita Puccinia striiformis Puccinia graminis Blumeria graminis Drechslera tritici-repentis Fusarium species Rhizoctonia cerealis Oculimacula species Puccinia recondita Rhynchosporium secalis Blumeria graminis Fusarium species Oculimacula species Mycosphaerella graminis Leptosphaeria nodorum Puccinia recondita Puccinia striiformis Blumeria graminis Rhynchosporium secalis Fusarium species Oculimacula species Mycosphaerella graminis Leptosphaeria nodorum Puccinia recondita Puccinia striiformis Puccinia graminis Blumeria graminis Drechslera tritici-repentis Fusarium species Foliar BBCH Foliar BBCH Foliar BBCH Foliar BBCH Acceptable Acceptable Acceptable Acceptable

18 Page 18 of Conclusions arising from French assessment Taking into account the above assessment, an authorisation can be granted as proposed in Appendix 1 Copy of the product Decision. 3.3 Substances of concern for national monitoring No information stated. 3.4 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Post-authorisation monitoring The monitoring of the resistance should be continued: - to bixafen, fluopyram and prothioconazole for septoria leaf blight - to prothioconazole for powdery mildew and eyespot. Efficacy trials in characterized resistance situation to prothioconazole for septoria leaf blight, powdery mildew and eyespot of wheat have to be put in place. Any new information likely to modify the assessment of risk of resistance for all uses must be provided to the competent authorities Post-authorisation data requirements No further information is required Label amendments The draft label proposed by the applicant in appendix 2 may be corrected with consideration of any new element under points (or 2.2.2), and The label shall reflect the detailed conditions stipulated in the Decision.

19 Page 19 of 31 Appendix 1 Copy of the French Decision

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26 Page 26 of 31 Appendix 2 Copy of the draft product label ASCRA Xpro PROJET DE TEXTE D ETIQUETTE 24/03/2014

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31 Page 31 of 31 Appendix 3 Letter(s) of Access Not applicable.