INTERFACE STERSSGARD ( ) Page 1 of 30. REGISTRATION REPORT Part A. Risk Management

Transcription

1 Page 1 of 30 REGISTRATION REPORT Part A Risk Management Product code: Product name: INTERFACE STRESSGARD Active Substances: Iprodione, 256,4 g/l Trifloxystribin, 16 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation) Applicant: BAYER SAS

2 Page 2 of 30 Table of Contents 1 DETAILS OF THE APPLICATION APPLICATION BACKGROUND ACTIVE SUBSTANCE APPROVAL REGULATORY APPROACH DATA PROTECTION CLAIMS LETTER(S) OF ACCESS DETAILS OF THE AUTHORISATION PRODUCT IDENTITY CLASSIFICATION AND LABELLING Classification and labelling under Directive 99/45/EC Classification and labelling in accordance with Regulation (EC) No1272/ Other phrases in compliance with Regulation (EU) No 547/ Otherphrases 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 Environmental fate and behaviour Ecotoxicology CONCLUSIONS ARISING FROM FRENCH ASSESSMENT SUBSTANCES OF CONCERN FOR NATIONAL MONITORING FURTHER INFORMATION TO PERMIT A DECISION TO BE MADE OR TO SUPPORT A REVIEW OF THE CONDITIONS AND RESTRICTIONS ASSOCIATED WITH THE AUTHORISATION Post-authorisation monitoring Post-authorisation data requirements Data gaps Label amendments (see label in Appendix 2): APPENDIX 1 COPY OF THE FRENCH DECISION APPENDIX 2 COPY OF THE DRAFT PRODUCT LABEL AS PROPOSED BY THE APPLICANT APPENDIX 3 LETTER(S) OF ACCESS... 27

3 Page 3 of 30 PART A Risk Management The company BAYER SAS has requested marketing authorisation in France for the product INTERFACE STRESSGARD (formulation code: ), containing g/l of iprodione and 16 g/l of trifloxystrobine 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 review. It also includes assessment of data and information relating to INTERFACE STRESSGARD where that data have not been considered in the EU review process. Otherwise assessments for the safe use of INTERFACE STRESSGARD have been made using endpoints agreed in the EU review of both iprodione and trifloxystrobin. This document describes the specific conditions of use and labelling required for France for the registration of INTERFACE STRESSGARD. 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 SAS s application to market INTERFACE STRESSGARD 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 Iprodione Regulations Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. Commission Implementing Regulation (EU) No 823/2012 of 14 September 2012 as regards the expiry dates of the approval of the active substances 2,4-DB, benzoic acid, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, cyfluthrin, deltamethrin, dimethenamid-p, ethofumesate, ethoxysulfuron, fenamidone, flazasulfuron, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mecoprop, mecoprop-p, mesosulfuron, mesotrione, oxadiargyl, oxasulfuron, pendimethalin, picoxystrobin, propiconazole, propineb, propoxycarbazone, propyzamide, pyraclostrobin, silthiofam, trifloxystrobin, warfarin and zoxamide. Specific provisions of regulation were as follows : PART A Only use as fungicide may be authorised PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States: - Should pay particular attention to the potential for ground water contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (ph below 6) under vulnerable climatic conditions,

4 Page 4 of 30 - Must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate. There is no definitive EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance. A Review Report is available (5036/VI/98-final., 3. December 2002). Trifloxystrobin Regulations Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. Commission Implementing Regulation (EU) No 823/2012of 14 September 2012 as regards the expiry dates of the approval of the active substances 2,4-DB, benzoic acid, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, cyfluthrin, deltamethrin, dimethenamid-p, ethofumesate, ethoxysulfuron, fenamidone, flazasulfuron, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mecoprop, mecoprop-p, mesosulfuron, mesotrione, oxadiargyl, oxasulfuron, pendimethalin, picoxystrobin, propiconazole, propineb, propoxycarbazone, propyzamide, pyraclostrobin, silthiofam, trifloxystrobin, warfarin and zoxamide. Specific provisions of regulation were as follows : PART A Only use as fungicide may be authorised PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: - Member States should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. - Risk mitigation measures should be applied and/or monitoring programs may be initiated where appropriate. 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/4339/2000-Final. 7. April 2003). 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. 1 2 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

5 Page 5 of 30 According to the French law and procedures, specific conditions of use are set in the decision letter. The French Order of 12 September provides that: - unless formally stated in the product authorisation, the pre harvest interval (PHI) is at least 3 days; - unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is 5 m; - unless formally stated in the product authorisation, the minimum re-entry delay is 6 hours for field uses and 8 hours for indoor uses. Drift reduction measures such as low-drift nozzles are not considered within the decision making process in France. However, drift buffer zones may be reduced under some circumstances as explained in appendix 3 of the abovementioned French order. The current document (RR) based on Anses assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/2009 4, and French regulation. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A of the RR presents a summary of essential scientific points upon which recommendations are based and is not intended to show the assessment in detail. The conclusions relating to the regulatory compliance are based on the criteria indicated in Regulation (EU) No546/2011 5, and are expressed as acceptable or not acceptable in accordance with those criteria. The decision, as duplicated in Appendix 1, takes also into account national provisions, including national mitigation measures. 1.4 Data Protection Claims Where protection for data is being claimed for information supporting registration of INTERFACE STRESSGARD, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access Not necessary: the applicant has provided sufficient data to show that access is not required. 2 DETAILS OF THE AUTHORISATION 2.1 Product Identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) Fongicide BAYER SAS iprodione g/l ; trifloxystrobin 16 g/l SC suspension concentrate Packaging HDPE (5 L or 10 L) 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

6 Page 6 of Classification and Labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June For information: Physical hazards No classification required Health hazards Xn Harmful Environmental hazards N Dangerous for the environment Risk phrases Safety phrases R40 Limited evidence of a carcinogenic effect R50/53 Very toxic to aquatic organisms may cause long-term adverse effects in the aquatic environment. S36/37 Wear suitable protective clothing and gloves. S60 S61 This material and its container must be disposed of as hazardous waste. Avoid release to the environment. Refer to special instructions/safety data sheets. Contains trifloxystrobin and 1,2 benzisothiazolin-3-one may produce an allergic reaction Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Carc. Cat. 2 Environmental hazards Aquatic acute toxicity Category 1 Aquatic cchronic toxicity Category 1 Hazard pictograms Signal word Warning Hazard statements H351 Suspected of causing cancer H400 H410 Very toxic to aquatic life Very toxic to aquatic life with long lasting effects Precautionary statements For the P phrases, refer to the extant legislation

7 Page 7 of 30 Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) EUH208 Contains trifloxystrobin and 1,2 benzisothiazolin-3-one. 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 1 SPe 2 Do not contaminate water with the product or its container (Do not clean application equipment near surface water/avoid contamination via drains from farmyards and roads). To protect groundwater, do not apply this or any other product containing iprodione on more than 10% of the area on soils with ph H 2 O < 6. On soils with ph H 2 O < 6, apply only between March and September and do not apply this or any other product containing iprodione at an application rates exceeding 2 x 2564 g/ha. On golf courses, apply the product only on greens and tees. To protect aquatic organisms, do not apply this product containing iprodione on more than 10% of the area for the use on sport grounds. On golf courses, apply the product only on greens and tees. SPe 3 To protect aquatic organisms respect an unsprayed buffer zone of 5 meters to surface water bodies Otherphrases linked to the preparation Wear suitable personal protective equipment 7 : refer to the Decision in Appendix 1 for the details Re-entry period 8 : 6 hours. Wait the completely drying the treated area Pre-harvest interval 9 : not applicable Other mitigation measures: - The preparation must be stored at a temperature below 40 C and must be shaken prior using. The label may include the following recommendations: - It must be mentioned on the label to rinse the container at least two times. 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, evaluated and concluded as safe uses by France as zrms. When the conclusion is not acceptable the intended use is highlighted in grey and the main reason(s) reported in the remarks. When a use is acceptable with GAP restrictions, the modifications of the GAP are in bold. Use should be crossed out when the applicant no longer supports this use. GAP rev. 1, date: PPP (product name/code) active substance 1 active substance 2 INTERFACE STRESSGARD/ iprodione trifloxystrobin Formulation type: SC Conc. of as 1: Conc. of as 2: 16 Applicant: Zone(s): BAYER SAS 16, rue Jean-Marie LECLAIR CS LYON Cedex 09 southern professional use non professional use Verified by MS: yes

9 Page 9 of 30.Crop and/ or situation (a) Country Product name F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment PHI (days) (l) Remarks: (m) Type (d-f) Conc. of as g/l (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications days (min) kg as/hl min max water L/ha min max kg as/ha min max Golf courses France INTERF ACE STRESS GARD Sport turf (football and rugby pitches, tennis, bowls and cricket pitches) France INTERF ACE STRESS GARD F F 1. Fusarium Patch 2. Dollar Spot (Sclerotinia) 3. Anthracnose 4. Brown Patch (Rhizoctonia) 5. Red Thread 6. Rust 7. Leaf Spot 1. Fusarium Patch 2. Dollar Spot (Sclerotinia) 3. Anthracnose 4. Brown Patch (Rhizoctonia) 5. Red Thread 6. Rust 7. Leaf Spot SC (1) (2) 16 SC (1) (2) 16 Spray (knapsack + lance or boom; vehicle mounted tank + boom) Spray (knapsack + lance or boom; vehicle mounted tank + boom) All year round 2 28 (1) (2) All year round 2 28 (1) (2) (1) (2) (1) (2) n.a. n.a. 10 L/ha INTERFACE STRESSGA RD the number of application is reduced from 4 to 2 for resistance management 10 L/ha INTERFACE STRESSGA RD the number of application is reduced from 4 to 2 for resistance management

10 Page 10 of 30 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

11 Page 11 of 30 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties The preparation INTERFACE STRESSGARD is a suspension concentrate formulation. All studies have been performed in accordance with the current requirements. The appearance of the formulation is a liquid, green with musty odor. It is not explosive and has no oxidizing properties. It has a self-ignition temperature of 515 C and a flash point above 100 C. Its ph is 6,4 at 21 C. Stability data indicate a shelf life of at least 3 years at ambient temperature (PEHD). Its technical characteristics are acceptable for a suspension concentrate formulation. The preparation must be stored at a temperature below 40 C and must be shaken prior using. It must be mentioned on the label to rinse the container at least two times Methods of analysis Analytical methods for the determination of active substances in the formulation are available and validated. Analytical methods are available in the monographs and in this dossier and validated for the determination of residues of iprodione and trifloxystrobin in soil, water (surface and drinking) and air. Analytical methods for the determination of residues of iprodione and trifloxystrobin in plants and foodstuff of animal origin are not necessary. To update the dossier, confirmatory methods for the determination of iprodione residues in soil, surface water with LOQ<0,1µg/L are required at the preapproval of the active substance. A confirmatory method in air is required if no confirmatory methods are available for soil or water. The active substances are neither toxic nor very toxic hence no analytical method is required for the determination of resides in biological fluids and tissues Mammalian Toxicology The acceptable daily intake (ADI) of iprodione, in the context of its evaluation for approbation, is 0.06 mg/kg bodyweight/day. This is based on the no observed adverse effect level (NOAEL) in a 2-year oral rat toxicity study and a 100-fold assessment factor. An acute reference dose (ARfD) for iprodione was considered to be not needed in the context of its evaluation for approbation. The acceptable daily intake (ADI) of trifloxystrobin, in the context of its evaluation for approbation, is 0.1 mg/kg bodyweight/day. This is based on the no observed adverse effect level (NOAEL) in a 2-year oral rat toxicity studies and a 100-fold assessment factor. An acute reference dose (ARfD) for trifloxystrobin was considered to be not needed in the context of its evaluation for approbation. The acceptable operator exposure level (AOEL) of iprodione, in the context of its evaluation for approbation, is 0.3 mg/kg bw/d. This is based on the no observed adverse effect level in a 90-day oral rat 100-fold assessment factor. The acceptable operator exposure level (AOEL) of trifloxystrobin, in the context of its evaluation for approbation, is 0.06 mg/kg bw/d. This is based on the no observed adverse effect level in a 2-year oral rat study and 100-fold assessment factor Acute Toxicity Acute toxicity studies were performed on IPD+TFS SC 2724 (256+16) formulation and yielded the following results:

12 Page 12 of 30 - Rat oral LD50 > 5000 mg/kg bw - Rat dermal LD50 > 5000 mg/kg bw - Rat inhalation LC50 > 2.56 mg/l/4h - No Skin irritancy effect with the rabbit - No Eye irritancy effect with the rabbit - No skin sensitisation in the mouse (LLNA) On the basis of these experimental results and the classification of active substances and co-formulants, the Anses Opinion concluded that the formulation is toxicologically classified Xn Carc. Cat. 3 R40 / Carc. Cat. 2 H351. According to directive 2006/8/EC, the label on the packaging shall bear the following statements: Contains trifloxystrobin and 1,2 benzisothiazolin-3-one. May produce an allergic reaction. Dermal absorption For iprodione, the values of 1% for undiluted and 1% for diluted for dermal absorption were used for exposure assessment for operator, bystander, worker based on in vivo rat study and an in vitro rat/human comparative study with a comparable SC formulation. For trifloxystrobin, the values of 1.6% undiluted for dermal absorption based on in vivo rat study and in vitro comparative rat/human study with EC formulation and 60% diluted (default value) (oral absorption value) for dermal absorption were used for exposure assessment for operator, bystander, worker Operator Exposure The following PPE are recommended as proposed by the applicant: Scenario : hand held sprayer or lance for mixing/loading - Gloves (nitrile, EN 374-3); - Working clothe non tissé category III type 5/6; OR - Gloves (nitrile, EN 374-3); - Working coveralls 65 % polyester / 35 % cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons of Category III and Type PB (3); during application - Gloves (nitrile, EN 374-3) - Bottes de protection certified EN ; - Working clothe non tissé category III type 5/6; during cleaning of material - Gloves (nitrile, EN 374-3); - Working clothe non tissé category III type 5/6; OR - Gloves (nitrile, EN 374-3); - Working coveralls 65 % polyester / 35 % cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons of Category III and Type PB (3). Scenario: tractor for mixing/loading - Gloves (nitrile, EN 374-3); - Working coveralls 65 % polyester / 35 % cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons of Category III and Type PB (3); during application If tractor with no cab - Working coveralls 65 % polyester / 35 % cotton; minimum 230 g/m²; with water repellent treatment;

13 Page 13 of 30 - Disposable nitrile gloves (EN 374-2) in the case of an intervention on application equipment, but not inside the cab. In the case of an intervention on application equipment, it should be noted that gloves should be worn only outside the tractor cab and stored after use outside the cab; If tractor with cab - Working coveralls 65 % polyester / 35 % cotton; minimum 230 g/m²; with water repellent treatment; - Disposable nitrile gloves (EN 374-2) in the case of an intervention on application equipment during spraying; during cleaning of material - Gloves (nitrile, EN 374-3); - Working coveralls 65 % polyester / 35 % cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons of Category III and Type PB (3). Model Estimates of operator exposure have been made using MODOP-ZNA v5-2 from the UPJ study data dedicated to non-agricultural areas for low-level target using a tractor: Dose 10L/ha Use on turf (golf courses) Model MODOP-ZNA v5-2,75 th percentile from UPJ studies Tractor (4 ha) Iprodione Hand-held sprayer (0.14 ha) Lance (1.4 ha) % AOEL Tractor (4 ha) Trifloxystrobine Hand-held sprayer (0.14 ha) Lance (1.4 ha) Working coverall Category III Type 5/ mixing/loading, no gloves Working coverall Category III Type 5/6 application, gloves during mixing/loading * 2.4* * 21.4* *Use of gloves during mixing/loading and application Field study The exposure of the operator as a result of the application of IPD+TFS SC 272,4 (256,4+16) via vehicle mounted ground boom application is calculated using experimental data. Full details of the assessment are provided in a separate report (KIIIA 7.3.3/01). There is no unacceptable risk anticipated for the operator with the intended use of IPD+TFS SC 272,4 (256,4+16) even if no protective equipment is used. However, according to good occupational practice it is recommended to wear in addition to one layer of typical work wear protective gloves during mixing/loading and when handling contaminated surfaces Bystander Exposure Estimate of bystander exposure according to EUROPOEM II model revealed that the risk is considered as acceptable for the intended use on turf and dose (0.1 % of AOEL for iprodione and 1.1% of AOEL for trifloxystrobin). An estimate of resident exposure (children) has been realized with BREAM model 2008, CRD and the risk is acceptable (17.2% AOEL iprodione and 60% AOEL trifloxystrobin) Worker Exposure Not relevant, no need to come in area treated (turf).

14 Page 14 of Environmental fate and behaviour The fate and behaviour in the environment of the formulation has been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review were used to calculate PECs for the 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 iprodione, trifloxystrobin 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. PEC soil and PECsw derived for the active substances and their metabolites are used for the eco-toxicological risk assessment, and mitigation measures are proposed. It is highlighted that PECsw for iprodione takes into account that only 10% of the area is treated. PECgw for iprodione and its metabolites and for trifloxystrobin and its metabolite CGA do not exceed the trigger of 0.1 µg/l for the intended uses. PECgw for trifloxystrobin metabolites CGA , NOA and NOA exceed 0.1 µg/l but not exceed 10 µg/l. Since these metabolites are not relevant according to guidance document SANCO/221/2000, no unacceptable risk of groundwater contamination is expected for the intended uses. It is highlighted that PECgw for iprodione under acidic conditions takes into account that only 10% of the area is treated. Based on vapour pressure, information on volatilisation from plants and soil, and DT50 calculation, no significant contamination of the air compartment is expected for the intended uses Ecotoxicology Given the sport grounds and golf courses (green and tee) uses, only aquatic organisms were considered in the risk assessment as this uses are supposed to be man-made surfaces. The PEC values were calculated by considering the FOCUS scenarios for grass. For FOCUS STEP 3 only the scenarios D were considered, as contamination by runoff is deemed not relevant for this kind of use. 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 iprodione and trifloxystrobin, their metabolites and data on the formulation IPD+TFS SC 272,4. The TER values for aquatic organisms based on PECsw values, calculated according to FOCUS, are in correspondence with the trigger values, indicating acceptable risks when INTERFACE STRESSGARD is applied at the proposed rate, when a 5 m buffer zone is applied Efficacy The product complies with the Uniform Principles. Considering the data submitted: - Minimum effective dose can be considered as acceptable. - Interest of the association was demonstrated. - Efficacy of the preparation against claimed diseases was demonstrated according to the 68 trials provided. - Impact risk on yield, quality, processing procedures, propagating purposes, adjacent crops and succeeding/replacement crops are considered as not pertinent because of use of the preparation on sport and golf turf. - Impact risk on selectivity is considered as acceptable according to efficacy trials and the 13 specific selectivity trials.

15 Page 15 of 30 - The risk of resistance development or appearance is considered as moderate to high. For that reason, the number of application is restricted to 2 applications/year. Any information about alteration of efficacy of the preparation on target disease should be provided. Uses new french catalogue Fusarium patch and helminthosporium of turf Rhizoctonia of turf Rusts of turf Dollar spot of grasses Various disease of turf (leaf spot) Red thread disease of turf Pink patch of turf Dose (L/ha) 10 L/ha 10 L/ha 10 L/ha 10 L/ha 10 L/ha 10 L/ha Dose active substance (g a.i./ha) I : 2564 T : 160 I : 2564 T : 160 I : 2564 T : 160 I : 2564 T : 160 I : 2564 T : 160 I : 2564 T : 160 Nb of application 4 applications 2 applications / years (resistance risk to QoI) Opinion of efficacy section Comments Favourable / Favourable / Favourable / Favourable / Favourable / Favourable / 3.2 Conclusions arising from French assessment Taking into account the above, 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 Any information about alteration of efficacy of the preparation on target disease should be provided Post-authorisation data requirements No further information is required Data gaps None 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.

16 Page 16 of 30 Appendix 1 Copy of the French decision

17 Page 17 of 30

18 Page 18 of 30

19 Page 19 of 30

20 Page 20 of 30

21 Page 21 of 30

22 Page 22 of 30

23 Page 23 of 30 Appendix 2 Copy of the draft product label as proposed by the applicant

24 Page 24 of 30

25 Page 25 of 30

26 Page 26 of 30

27 Page 27 of 30 Appendix 3 Letter(s) of Access

28 Page 28 of 30

29 Page 29 of 30

30 Page 30 of 30