ALMANACH FLASH ( ) 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: ALMANACH FLASH Active Substances: cymoxanil, 26.7 g/kg fosetyl-aluminium, 333 g/kg mancozeb, 333 g/kg COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (authorisation renewal and label extension)

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 (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... 24

3 Page 3 of 31 PART A Risk Management The company TRADI-AGRI has requested marketing authorisation in France for the product ALMANACH FLASH (formulation code : ), containing 26.7 g/kg cymoxanil, 333 g/kg mancozeb and 333 g/kg fosetyl-aluminium for use as an 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 reviews of cymoxanil, fosetyl-aluminium and mancozeb. 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 letters of Access. 1 DETAILS OF THE APPLICATION 1.1 Application background The present registration report concerns the evaluation of TRADI-AGRI s application to market 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 renewal of authorisation of this product in France and in other MSs of the Southern zone after approval of cymoxanil. Applications for a minor extension of use and a modification of the declared information were treated concurrently. 1.2 Active substance approval Cymoxanil 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 were as follows : PART A Only uses as fungicide 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 cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

4 Page 4 of 31 the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. An EFSA Conclusion is available (EFSA Scientific Report (2008) 167, 1-116). A Review Report is available (SANCO/179/08 - final rev 1, 9 July 2010). Fosetyl-aluminium 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 678/2014 of 19 June 2014 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clopyralid, cyprodinil, fosetyl, pyrimethanil and trinexapac. Specific provisions of regulation were as follows : PART A Only uses as fungicide 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 fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval. Regulation (EU) No 678/2014 extended the approval s expiry date to 30 April An EFSA conclusion is available (EFSA Scientific Report (2005) 54, 1-79). Review Reports are available (SANCO/10015/06 final, 4 April 2006 [Annex I inclusion]; (SANCO/10015/06 final, 20 November 2012 [confirmatory data]).

5 Page 5 of 31 Mancozeb 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 762/2013 of 7 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, MCPA, MCPB and metiram. Specific provisions of regulation were as follows : PART A Only uses as fungicide 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 mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request mancozeb has been included in this Annex provide such studies to the Commission within two years from the approval. Regulation (EU) No 762/2013 extended the approval s expiry date to 31 January There is no definitive EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance. A Review Report is available (SANCO/4058/2001 rev 4.4, July 2009). 1.3 Regulatory approach The present applications ( [authorisation renewal] and [label extension) were 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 4th May 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 metres; - unless formally stated in the product authorisation, the minimum re-entry period is 6 hours for field uses and French Food Safety Agency, Afssa, before 1 July 2010 SANCO document risk envelope approach, European Commission (14 March 2011). Guidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach ; SANCO/11244/2011 rev. 5 Arrêté du 4 mai 2017 relatif à la mise sur le marché et à l'utilisation des produits phytopharmaceutiques et de leurs adjuvants visés à l'article L du code rural et de la pêche maritime

6 Page 6 of 31 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 Commission Directive 2008/125/EC of 19 December 2008 and French regulations. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A of the RR presents a summary of essential scientific points upon which recommendations are based and is not intended to show the assessment in detail. The conclusions relating to the acceptability of risk are based on the criteria indicated in Regulation (EU) No 546/2011 5, and are expressed as acceptable or not acceptable in accordance with those criteria. Finally, the French Order of 26 March provides that: - an authorisation granted for a reference crop applies also for linked crops, unless formally stated in the Decision - the reference and linked crops are defined in Appendix 1 of that French Order. Thus, at French national level, possible extrapolation of submitted data and the corresponding assessment from reference crops to linked ones are undertaken even if not clearly requested by the applicant in their drr, and a conclusion is reached on the acceptability of the intended uses on those linked crops. The aim of this Order, mainly based on the EU document on residue data extrapolation 7 is to supply minor crops with registered plant protection products. Therefore the GAP table (Section 2.3) and Decision may include uses on crops not originally requested by the applicant. The Decision, as reproduced in Appendix 1, takes also into account national provisions, including national mitigation measures. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of ALMANACH FLASH ( ), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access The applicant has provided the supporting data in Document K; the ownership of the data is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7. A copy of the letter(s) of access is reproduced in Part A, Appendix 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

7 Page 7 of 31 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function Applicant Composition Fungicide TRADI-AGRI 26.7 g/kg cymoxanil 333 g/kg fosetyl-aluminium 333 g/kg mancozeb Formulation type (code) Packaging Water-dispersible granule (code: WG) Polyethylene/oriented polypropylene/aluminium/polyethylene bag-in-box, containing 9 kg product 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 Self-Heating Substances and Mixtures, Hazard Category 1 Health hazards Reproductive toxicity, Hazard Category 2 Sensitisation Skin, Hazard Category 1 Environmental hazards Hazardous to the aquatic environment Chronic Hazard, category 2 Hazard pictograms Signal word Danger Hazard statements H251 Self-heating: may catch fire. H361d H317 H411 Suspected of damaging the unborn child. May cause an allergic skin reaction. Toxic to aquatic life with long-lasting effects.

8 Page 8 of 31 Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) For the P phrases, refer to the extant legislation - Contains hexamethylene tetramine. May produce an allergic reaction. 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 50 metres 8 to surface water bodies with 5 metres permanent vegetative strip to surface water bodies. This 5-metre vegetative strip also reduces the risk of eutrophication. To protect non-target arthropods/insects, respect an unsprayed buffer zone of 20 metres to nonagricultural land Other phrases linked to the preparation Wear suitable personal protective equipment 9 : refer to the Decision in Appendix 1 for the details Re-entry period 10 : 48 hours Pre-harvest interval 11 : Table and wine grapes: 28 days Other mitigation measures: - Stir the preparation vigorously during application, in accordance with good agricultural practice. - The product must be stored at temperatures below 40 ºC - Use of ALMANACH FLASH against rotbrenner disease (Pseudopeziza tracheiphila) and black rot (Phyllosticta ampelicida) must only be undertaken as part of a joint control programme against downy mildew (Plasmopara viticola) The legal basis for this is Titre III Article 12of the French Order of 4th May 2017 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] If a tractor with cab is used, wearing gloves during application is only required when working with the spray mixture The legal basis for this is Titre I Article 3 of the French Order of 4th May 2017 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] According to the French Order of 4th May 2017, PHI cannot be lower than 3 days unless specifically stated in the assessment and decision.

9 Page 9 of 31 The label must include the following statement: Contains hexamethylene tetramine. May produce an allergic reaction. The label must reflect the conditions of authorisation.

10 Page 10 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 a use is acceptable with GAP restrictions, the modifications of the GAP are in bold. PPP (product name/code) active substance 1 cymoxanil active substance 2 fosetyl-aluminium active substance 3 mancozeb Applicant: TRADI-AGRI Zone: Southern EU Verified by MS: yes Formulation type: Conc. of as 1: Conc. of as 2: Conc. of as 3: professional use non professional use GAP rev. 1, date: 2017-november-30 water-dispersible granule (WG) 26.7 g/kg 333 g/kg 333 g/kg Crop and/ or situation Zone Product code F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment PHI (days) (l) Remarks: (m) (a) Type (d-f) Conc. of a.s. (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) g a.s./hl min max water L/ha min max g a.s./ha min max Grapes (wine and table) France F Excoriose (dead-arm) (Cryptosporella viticola) F Downy mildew (Plasmopara viticola) WG WG Cymoxanil: 26.7 g/kg Mancozeb: 333 g/kg Fosetyl: 333 g/kg Cymoxanil: 26.7 g/kg Mancozeb: 333 g/kg Fosetyl: 333 g/kg Spray BBCH Spray BBCH days Acceptable Acceptable 4 application per crop to control all diseases

11 Page 11 of F Rotbrenner disease (Pseudopeziza tracheiphila) F Black rot (Phyllosticta ampelicida) WG WG Cymoxanil: 26.7 g/kg Mancozeb: 333 g/kg Fosetyl: 333 g/kg Cymoxanil: 26.7 g/kg Mancozeb: 333 g/kg Fosetyl: 333 g/kg Spray BBCH Spray BBCH days 10 days Acceptable 4 application per crop to control all diseases Acceptable 4 application per crop to control all diseases 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

12 Page 12 of 31 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties is a light beige odourless water-dispersible granule formulation. All studies have been performed in accordance with the current requirements. It is not explosive and has no oxidising properties. It is not flammable. The product is classified H251 Cat 1 according to regulation (CE) n 1272/2008. In aqueous solution (1 %), its ph is 4.2 at 24 C. Stability data indicate a shelf life of at least 2 years at ambient temperature (PE). Its technical characteristics are acceptable for a water dispersible granule formulation. The preparation must be stirred during application Methods of analysis Analytical method for the formulation Analytical methods for the determination of active substances and relevant impurity ethylenethiourea (ETU) in the formulation are available and validated Analytical methods for residues Analytical methods are available in the Draft Assessment Reports and in this dossier and validated for the determination of residues of mancozeb, cymoxanil and fosetyl-al in plants (acidic), soil, water (surface and drinking) and air. Analytical methods for the determination of residues of active substances in foodstuffs of animal origin are not necessary. To update the dossier and to be in accordance with SANCO 825/00/rev8.1, the following methods are required for the renewal of the active substance: A confirmatory method for the determination of cymoxanil residues in soil A confirmatory method for the determination of mancozeb in surface water The active substances are neither toxic nor very toxic, hence no analytical method is required for the determination of residues in biological fluids and tissues Mammalian Toxicology Acute Toxicity containing 333 g/kg of mancozeb, 26.7g/kg of cymoxanil and 333 g/kg of fosetyl-al has a low acute oral, dermal and inhalational toxicity, and is not irritating to the rabbit eye and skin. It has been found to be a dermal sensitiser Operator Exposure Operator exposure for the use on grapevines has been assessed with the BBA model against the AOEL of mg/kg bw/d for mancozeb, 0.01 mg/kg bw/d for cymoxanil and 5 mg/kg bw/d for fosetyl-al. The dermal absorption value of mancozeb used for risk assessment is 0.24 % for the non-diluted and diluted (based on an in vivo study on rat undertaken on a similar formulation). The dermal absorption values of cymoxanil used for risk assessment are 5 % for the non-diluted and 5 % for the diluted (based on an in vitro study on human and rat skin and an in vivo study on rat skin realized on a similar preparation).).

13 Page 13 of 31 The dermal absorption value of fosetyl-al used for risk assessment 1 % for the non-diluted and diluted respectively (based on an in vitro comparative study on human and rat skin on a similar formulation). The risk for the operator using on grapevine is acceptable with a tractor mounted/trailed broadcast air-assisted sprayer with a working coverall and gloves during the mix/loading and application phases (15.5 %,20 % and 0.2 % of mancozeb s AOEL, cymoxanil s AOEL and fosetyl-al s AOEL respectively. A cumulative risk assessment was performed and resulted in an acceptable risk (IR<1). For details of personal protective equipment for operators, refer to the Decision in Appendix Bystander Exposure The bystander exposure for the use on grapevine represents 4.9 % of mancozeb s AOEL, 36 % of cymoxanil s AOEL and 0.05 % of fosetyl-al s AOEL. The risk is considered acceptable. A cumulative risk assessment was performed and resulted in an acceptable risk (IR<1). The resident exposure was calculated using measured concentrations of cyprodinil in air and is considered negligible compared to the ARfD or AOEL values Worker Exposure The worker exposure for the use on grapevine represents 6.2 % of mancozeb s AOEL, 36 % of cymoxanil s AOEL and 0.2 % of fosetyl-al s AOEL with a working coverall and gloves. The risk for workers is considered acceptable. For details of personal protective equipment for workers, refer to the Decision in Appendix Residues and Consumer Exposure Residues Primary crop metabolisms were sufficiently investigated to define residue of the active substances for enforcement and risk assessment purposes in the crops under consideration (table and wine grapes). Regarding the magnitude of residues in grape, a sufficient number of residue trials is available to support the intended GAPs in France. These data allowed it to be considered that no MRL exceedance will result from the intended uses. The effects of processing on the nature of cymoxanil, mancozeb and fosetyl-al residues have been investigated during Annex I inclusion (approval) and are considered acceptable and sufficiently addressed. As grape is a perennial crop, considerations about succeeding crops were not required in the framework of this dossier. As grapes or grape-based products are not fed to animals, the intended uses one grape do not modify the dietary burden for beef, dairy cattle and pig. Further investigations of residues, as well as the modification of MRLs in commodities of animal origin, are therefore not necessary Consumer exposure The toxicological profiles of cymoxanil, mancozeb and fosetyl-al were evaluated at EU level, which resulted in the proposal of ADIs (0.05 mg/kg for mancozeb, mg/kg for cymoxanil and 3 mg/kg for fosetyl-al) and ARfDs (0.6 mg/kg for mancozeb and 0.08 mg/kg for cymoxanil) that were considered in the framework of this evaluation.

14 Page 14 of 31 Chronic and acute consumer exposures resulting from the uses proposed in the framework of this application were calculated for all active substances. Based on EFSA PRIMo (rev2) chronic and acute exposures were considered acceptable for all groups of consumers. According to the available data, no specific mitigation measures should apply 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 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 the active substances and their 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. The results for PEC soil and PECsw for the active substances and their metabolites are used for the ecotoxicological risk assessment and mitigation measures (5 m of vegetative filter strip to limit eutrophication) are proposed. PECgw for the active substances and their metabolites do not exceed the trigger of 0.1 µg/l. Therefore, no unacceptable risk of groundwater contamination is expected from 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. Implications for labelling resulting from environmental fate assessment: The following labelling (SPe 3) is proposed at national level: "To protect surface water from eutrophication, respect an unsprayed buffer zone with 5-metre permanent planted strip to adjacent surface water bodies." 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, earthworms, other soil macro-organisms and micro-organisms are acceptable for the intended uses. For aquatic organisms, the risks are acceptable when a no spray zone of 50 metres including a 5-metre permanent planted strip is applied. For non-target arthropods, the risks are acceptable when a buffer zone of 20 metres is applied Efficacy Downy mildew of grapevine (Plasmopara viticola) After evaluation, it was concluded that submitted data on efficacy and adverse or unintended side effects are generally in compliance with the Uniform Principles. The proposed application rate of against P. viticola of grapevine is 4.5 kg/ha. The recommended maximum number of applications is 4 with a minimum interval of 10 days.

15 Page 15 of 31 No adverse effects on the quality of plants and plant products, on the processing procedure and on the yield of treated plants and plant products are expected when is used as proposed. No symptoms of phytotoxicity, no adverse effects on parts of plants used for propagating purposes, no impact on succeeding crops and on other plants, including adjacent crops are expected when ALMANACH FLASH ( ) is used as proposed. Resistance: The maximum number of applications is limited to 4 applications to control P. viticola. Moreover, to prevent the risk of resistance development, the applicant must continue the present monitoring and inform the competent authorities of any changes to the current context of resistance. Dead-arm of grapevine (Cryptosporella viticola) After evaluation, it was concluded that submitted data on efficacy and adverse or unintended side effects are generally in compliance with the Uniform Principles. The proposed application rate of against C. viticola is 4.5 kg/ha. The recommended maximum number of applications is 1 per year. No adverse effects on the quality of plants and plant products, on the processing procedure and on the yield of treated plants and plant products are expected when is used as proposed. No symptoms of phytotoxicity, no adverse effects on parts of plants used for propagating purposes, no impact on succeeding crops and on other plants, including adjacent crops, are expected when ALMANACH FLASH ( ) is used as proposed. Resistance: The maximum number of applications is limited to 1 application to control C. viticola. Rotbrenner disease (Pseudopeziza tracheiphila) and black rot (Phyllosticta ampelicida) of grapevine After evaluation, it was concluded that submitted data on efficacy and adverse or unintended side effects are generally in compliance with the Uniform Principles. The proposed application rate of against P. tracheiphila and P. ampelicida is 4.5 kg/ha. The recommended maximum numbers of applications is 4 per year. No adverse effects on the quality of plants and plant products, on the processing procedure and on the yield of treated plants and plant products are expected when is used as proposed. No symptoms of phytotoxicity, no adverse effects on parts of plants used for propagating purposes, no impact on succeeding crops and on other plants, including adjacent crops, are expected when the preparation ALMANACH FLASH ( ) is used as proposed. Resistance: The active substances are at low (mancozeb and fosetyl-al) to moderate (cymoxanil) risk of development or appearance of resistance. The resistance strategies proposed by the applicant to reduce the risk of resistance development, namely the alternation of active substances with different modes of action and the limitation to 4 applications per year of, whatever the product used, are acceptable to control rotbrenner disease and black rot of grapevine.

16 Page 16 of 31 Conclusion for France Crops Grapevine * dead-arm (Cryptosporella viticola) Grapevine * downy mildew (Plasmopara viticola) Grapevine * rotbrenner disease (Pseudopeziza tracheiphila) Grapevine * black rot (Phyllosticta ampelicida) Maximum application rate per treatment Maximum number of applications per use Maximum number of applications per year Conclusion of France for efficacy section 0.45 kg/hl 1 1 Acceptable 4.5 kg/ha 4 4 Acceptable 4.5 kg/ha 4 4 Acceptable 4.5 kg/ha 4 4 Acceptable Remarks Data on the usefulness of cymoxanil are necessary ALMANACH FLASH ( ) must be used only as part of a joint control programme against downy mildew. 3.2 Conclusions arising from French assessment 3.3 Taking into account the above assessment, an authorisation can be granted as proposed in Appendix 1 Copy of the product Decision. 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 3.5 Post-authorisation monitoring Monitoring for the appearance of resistance of grape downy mildew (Plasmopara viticola) must be continued. Any change compared with the current resistance situation must be reported to the competent authorities Post-authorisation data requirements For efficacy section, the following confirmatory data would have been necessary or requested at the time of the renewal of the preparation: - Data must be provided to demonstrate the curative effect of cymoxanil when in association with fosetylaluminium and mancozeb [according to the specific study plan described in Part B of the Registration Report] 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.

17 Page 17 of 31 Appendix 1 Copy of the French Decision

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23 Page 23 of 31 Appendix 2 Copy of the draft product label as proposed by the applicant

24 Page 24 of 31 Appendix 3 Letter(s) of Access

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