SYLLIT 544 SC Page 1 of 26. REGISTRATION REPORT Part A. Risk Management. Product name(s): SYLLIT 544 SC Active Substance(s): dodine, 544 g/l

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1 Page 1 of 26 REGISTRATION REPORT Part A Risk Management Product name(s): Active Substance(s): dodine, 544 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation),

2 Page 2 of 26 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... 26

3 Page 3 of 26 PART A Risk Management The company ARYSTA LIFESCIENCE BENELUX SPRL has requested marketing authorisation in France for the product, containing 544 g/l dodine 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 SYLLIT 544 SC 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 dodine. 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 BENELUX SPRL 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 first authorisation of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval dodine 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 as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the potential long-term risk to birds and mammals; (b) the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures; (c) the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures; (d) the monitoring of residue levels in pome fruit.

4 Page 4 of 26 The Member States concerned shall request the submission of confirmatory information as regards: (a) long-term risk assessment for birds and mammals; (b) risk assessment in natural surface water systems where major metabolites have potentially formed. 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 2010; 8(6):1631). A Review Report is available (SANCO/12248/2010 final, 23 November 2010). 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, 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 26 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, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access Not necessary: the applicant has provided sufficient data to show that access is not required. 7 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 26 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) Packaging 2.2 Classification and labelling fungicide ARYSTA LIFESCIENCE BENELUX SPRL 544 g/l dodine Suspension concentrate (SC) Classification and labelling under Directive 99/45/EC Not applicable after 1st June PET or HDPE bottles (1L); PET or HDPE containers (5L) Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Acute toxicity (oral), cat.4 Acute toxicity (inhalation), cat 4 Eye damage, cat 1 Skin Irritation, cat 2 Environmental hazards Hazard pictograms Aquatic Chronic 1 Aquatic Acute 1 Signal word Danger Hazard statements H302 Harmful if swallowed Precautionary statements H315 H318 H332 H400 H410 Supplementary EUH208 information (in accordance with Article 25 of Regulation (EC) No 1272/2008) Causes skin irritation Causes serious eye damage Harmful if inhaled Very toxic to aquatic life Very toxic to aquatic life with long lasting effects For the P phrases, refer to the extant legislation Contains 1,2-benzisothiazol-3-one. May produce an allergic reaction.

7 Page 7 of 26 See Part C for justifications of the classification and labelling proposals Other phrases in compliance with Regulation (EU) No 547/2011 The authorisation of the preparation is linked for professional uses only to the following conditions: SP 1 SPe 3 SPe 3 Do not contaminate water with the product or its container (Do not clean application equipment near surface water/avoid contamination via drains from farmyards and roads). To protect aquatic organisms, respect an unsprayed buffer zone of 5 metres 8 to surface water bodies for uses on olives To protect aquatic organisms respect an unsprayed buffer zone of 20 meters to surface water bodies for uses on pome fruits (apple, Asian pear, quince), peaches and nectarines and cherries 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 : 24 hours Pre-harvest interval 11 : - Pome fruits : 60 days - Cherries : 14 days - Peaches and nectarines : 75 days - Olives : 7 days Other mitigation measures: The formulation must be shaken before use. 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] If a tractor with cab is used, wearing gloves during application is only required when working with the spray mixture The legal basis for this is Titre I Article 3 of the French Order of 12 September 2006 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] According to the French Order of 12 September 2006, PHI cannot be lower than 3 days unless specifically stated in the assessment and decision.

8 Page 8 of Product uses Please note: The GAP Table below reports the intended uses proposed by the applicant, and possible extrapolation according to French Order of 26 March 2014 (highlighted in green), evaluated and concluded as safe uses by France as zrms. Those uses are then granted in France. 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 dodine Formulation type: Conc. of as 1: GAP rev. 2, date: July 2016 SC 544 g/l Applicant: Zone(s): Verified by MS: yes Arysta Lifescience Benelux SPRL southern professional use non professional use Crop and/ or situation (a) Apples/Pears and other pome fruit such as quince, medlar and loquat Cherries (sweet and sour) Zone Product code F G or I (b) EU- South Pests or Group of pests controlled (c) Syllit 544 SC F Scab (Venturia ineaqualis [VENTIN] / Venturia piri [VENTPI]) EU-South Syllit 544 SC F Cherry leaf spot (Blumeriella jaapii [BLUMJA]) (synonym: Coccomyces hiemalis) and leaf scorch of cherry (Apiognomonia erythrostoma [GNOMER] (synonym: Gnomonia erythrostoma)) Formulation Application Application rate per treatment Type (d-f) Conc. of as (i) method kind (f-h) growth stage & season (j) SC 544 g/l Foliar spray From bud opening (BBCH 01) till 60 days before harvest SC 544 g/l Foliar spray From flower opening (BBCH 60) till 2 weeks before harvest (BBCH 79) and/or after harvest number min max (k) interval between applications (min) kg as/hl min max water L/ha min max days L days L kg as/ha min max PHI (days) (l) Remarks: (m) days Acceptable 1.25 L Syllit 544 SC/ha days Acceptable 1.25 L Syllit 544 SC/ha

9 Page 9 of 26 Peaches, nectarines and similar hybrids Olives (table olives and olives for oil production) EU-South Syllit 544 SC F Peach Leaf curl (Taphrina deformans [TAPHDE]) EU-South Syllit 544 SC F Olive leaf spot (Cycloconium oleaginum [CYCLOL] (synonym: Spilocaea oleaginea)) and Glomerella cingulata [GLOMCI] (synonyms: Gloeosporium olivarum, Colletotrichum gloeosporioides) SC 544 g/l Foliar spray From bud swelling (BBCH 01) till petal fall (BBCH 69) and/or later from 50% leaf falling till after leaf falling (autumn) SC 544 g/l Foliar spray From leaf development (BBCH 11) till end of flowering (BBCH 69) and/or in autumn (before and after harvest) days L days Acceptable 1.65 L Syllit 544 SC/ha days days Acceptable L Syllit 544 SC/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 26 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 Suspension Concentrate formulation. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of opaque white liquid with a small clear liquid layer on the top and small sediment on the bottom, with a faint chemical odour. It is not explosive and has no oxidizing properties. The product is not flammable has a flash point superior of 79 C. It has a self-ignition temperature of 404 C. In 1% aqueous solution, it has a ph value of 6.49 at 20 C. 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 3 years at ambient temperature when stored in HDPE and PET. As the formulation is a SC, all the packaging can be considered as acceptable. Its technical characteristics are acceptable for a SC formulation. The formulation is not classified for the physical-chemical part. The formulation must be shaken before use Methods of analysis Analytical method for the determination of active substance in the formulation is available and validated. As the active substance dodine does not contain relevant impurity, no analytical method is required. Analytical methods are available in the monograph and in this dossier and validated for the determination of residues of dodine in plants (high wet, oily and acidic matrices), food of animal origin, soil, water (surface and drinking) and air. According to EFSA Journal 2010; 8(6):1631, the active substance is toxic, therefore an analytical method is available in the monograph and validated for the determination of residues of dodine in tissues and body fluids. An ILV in liver and an ILV in milk, eggs, meat and fat according to SANCO/825/00 rev 8.1 are actually pending and are expected to be available in April The study plans of these studies are provided (S and S ). To update the dossier, these ILV methods should be provided in post-registration Mammalian Toxicology Endpoints used in risk assessment Active Substance: Dodine ADI ARfD 0.1 mg kg bw/d 0.1 mg/kg bw EU 2011 AOEL Dermal absorption mg/kg bw/d Based on an in vitro and in vivo ratand in vitro human studies performed on a similar formulation (pro rata correction) and peer review at European level Concentrate (tested) 400 g/l Diluted formulation (tested) 0.45 g/l In vivo (rat) % In vitro (rat) %

11 Page 11 of 26 Concentrate (used in formulation) 544 g/l Spray dilution (used in formulation) 0.45 g/l Dermal absorption endpoints % Acute Toxicity containing 544 g/l dodine has a low toxicity in respect to acute oral and inhalation toxicity. By extrapolation with results obtained with a similar formulation, is judged irritating to the rabbit skin or eye. Moreover by calculation, is not a skin sensitizer Operator Exposure Summary of critical use patterns (worst cases): Crop F/G 12 Equipment Application rate L product/ha (g as/ha) Spray dilution (L/ha) Model Fruits orchards (risk envelop) F Tractor mounted/trailed broadcast airassisted sprayer L/ha ( kg as/ha) 200 BBA Olive Hand-held sprayer (high level target) 1000 BBA Considering proposed uses, operator systemic exposure was estimated using the German BBA model and UK- POEM model: Crop Equipment PPE and/or working coverall % AOEL dodine Fruits orchards (risk envelop) Olive Tractor mounted/trailed broadcast air-assisted sprayer (BBA) Hand-held sprayer (high level target) (BBA) 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 is acceptable with a working coverall (90% protection factor) and gloves during mixing/loading and application Bystander Exposure Bystander exposure was assessed according to EUROPOEM II. Exposure is estimated to 7.8 % of the AOEL of dodine. It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to Worker Exposure 12 Open field or glasshouse

12 Page 12 of 26 Workers may have to enter treated areas after treatment for crop inspection and harvesting activities. Therefore, estimation of worker exposure was calculated according to EUROPOEM II. Exposure is estimated to 84% of the AOEL of dodine. It is concluded that without taking into account a re-entry period, there is no unacceptable risk anticipated for workers not wearing PPE, when re-entering crops treated with Residues and Consumer Exposure The data available are considered sufficient for risk assessment. An exceedance of the current MRL for dodine as laid down in Reg. (EU) 396/2005 is not expected. The chronic and the short-term intakes of dodine residues are unlikely to present a public health concern. As far as consumer health protection is concerned, France, zrms agrees with the authorization of the intended use(s). According to available data, no specific mitigation measures should apply Residues The preparation is composed of dodine. Table 3.1-1: Summary for dodine Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance SANTE/103 76/2015 Chronic risk for consumers identified? Acute risk for consumers identified? Comments / Pome fruits Yes Yes Yes Yes Yes No / Cherries Yes Yes Yes Yes Yes No / Peaches and nectarines Yes Yes Yes Yes Yes No No / Olives Yes Yes Yes Yes Yes No * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 The effects of processing on the nature of dodine 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. All intended uses are perennial crops. Consideration about residues in succeeding crops is not required. 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 Table 3.1-2: Information on (KCA 6.8) Crop PHI for SYLLIT 544 SC proposed by applicant PHI/ Withholding period* sufficiently supported for dodine PHI for SYLLIT 544 SC proposed by zrms zrms Comments (if different PHI proposed) Pome fruits 60 days Yes 60 days

13 Page 13 of 26 Crop PHI for SYLLIT 544 SC proposed by applicant PHI/ Withholding period* sufficiently supported for dodine PHI for SYLLIT 544 SC proposed by zrms zrms Comments (if different PHI proposed) Cherries 14 days Yes 14 days Peaches and nectarines 75 days Yes 75 days Olives 7 days Yes 7 days 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 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 dodine 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 dodine are used for the eco-toxicological risk assessment and risk mitigation measures are proposed. PECgw for dodine do not occur at levels exceeding those mentioned in regulation EC 1107/2009. 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 The ecotoxicological risk assessment of the formulation was performed according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU conclusions for the active substance(s) and its/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, other soil macro-organisms and micro-organisms are acceptable for the intended uses Efficacy This conclusion concerned the preparation SYLLIT 544SC, composed of 544g/L of dodine. Dodine is already registered in Europe and used on different crop in France against fungi. France is zrms for this dossier for Bulgary, Cyprus, Greece, Italy, Malta, Portugal and Spain. Considering the data submitted:

14 Page 14 of 26 - The efficacy of SYLLIT 544SC is considering as satisfying - The selectivity of SYLLIT 544SC is considered as satisfying - The risk of negative impact (yield, quality, transformation processes, propagation, succeeding crops and adjacent crops) is considered as negligible - The risk of resistance development or appearance is considered as acceptable. In France, some efficacy loss has been reported in apple orchard in the last ten year. This loss of efficacy might not be linked to resistance (lower sensibility of scab strain to dodine). The applicant asks for a limitation of two applications per season to avoid the risk. 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. 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 It will be necessary to establish or continue to monitor the resistance to dodine in apple scab. New information likely to modify the assessment of risk of resistance must be provided for all uses to the competent authorities Post-authorisation data requirements The French Decision requests the submission of post-authorisation confirmatory pieces of information within 6 months regarding: - An ILV in liver and an ILV in milk, eggs, meat and fat according to SANCO/825/00 rev 8.1 are actually pending and are expected to be available in April The study plans of these studies are provided (S and S ) 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.

15 Page 15 of 26 Appendix 1 Copy of the French Decision

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21 Page 21 of 26 Appendix 2 Copy of the draft product label as proposed by the applicant

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26 Page 26 of 26 Appendix 3 Letter(s) of Access Not applicable.