Page 1 of 26 REGISTRATION REPORT Part A Risk Management Product code: TBZ+TDL EC 300 (Specification: 102000013167) Product name: ABILIS Active Substance: tebuconazole, 225 g/l triadimenol, 75 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (renewal of marketing authorisation) Date: 29/01/2016 (Decision)
Page 2 of 26 Table of Contents 1 DETAILS OF THE APPLICATION... 3 1.1 APPLICATION BACKGROUND... 3 1.2 ACTIVE SUBSTANCE APPROVAL... 3 1.3 REGULATORY APPROACH... 5 1.4 DATA PROTECTION CLAIMS... 6 1.5 LETTER(S) OF ACCESS... 6 2 DETAILS OF THE AUTHORISATION... 6 2.1 PRODUCT IDENTITY... 6 2.2 CLASSIFICATION AND LABELLING... 7 2.2.1 Classification and labelling under Directive 99/45/EC... 7 2.2.2 Classification and labelling in accordance with Regulation (EC) No1272/2008... 7 2.2.3 Other phrases in compliance with Regulation (EU) No 547/2011... 7 TO PROTECT AQUATIC ORGANISMS, RESPECT AN UNSPRAYED BUFFER ZONE OF 5 METRES TO SURFACE WATER BODIES (USES IN GRAPE). 7 2.2.4 Other phrases linked to the preparation... 8 2.3 PRODUCT USES... 9 3 RISK MANAGEMENT... 11 3.1 REASONED STATEMENT OF THE OVERALL CONCLUSIONS TAKEN IN ACCORDANCE WITH THE UNIFORM PRINCIPLES... 11 3.1.1 Physical and chemical properties... 11 3.1.2 Methods of analysis... 11 3.1.3 Mammalian Toxicology... 11 3.1.4 Residues and Consumer Exposure... 12 3.1.5 Environmental fate and behaviour... 13 3.1.6 Ecotoxicology... 13 THE RISK TO AQUATIC ORGANISMS FOLLOWING EXPOSURE TO TEBUCONAZOLE, TRIFLOXYSTROBIN AND THEIR METABOLITES AFTER APPLICATIONS OF TBZ+TDL EC 300 COULD BE CONSIDERED ACCEPTABLE WITH 5-METRE SPRAY DRIFT BUFFER.... 13 3.1.7 Efficacy... 14 3.2 CONCLUSIONS ARISING FROM FRENCH ASSESSMENT... 14 3.3 SUBSTANCES OF CONCERN FOR NATIONAL MONITORING... 14 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... 14 3.4.1 Post-authorisation monitoring... 14 3.4.2 Post-authorisation data requirements... 14 3.4.3 Label amendments (see label in Appendix 2):... 14 APPENDIX 1 COPY OF THE FRENCH DECISION... 15 APPENDIX 2 COPY OF THE DRAFT PRODUCT LABEL AS PROPOSED BY THE APPLICANT... 22 APPENDIX 3 LETTER(S) OF ACCESS... 26
Page 3 of 26 PART A Risk Management The company BAYER S.A.S. has requested marketing authorisation in France for the product ABILIS (formulation code: TBZ+TDL EC 300), containing 225 g/l tebuconazole and 75 g/l triadimenol 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 ABILIS where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of ABILIS have been made using endpoints agreed in the EU peer reviews of tebuconazole and triadimenol. This document describes the specific conditions of use and labelling required for France for the registration of ABILIS. Appendix 1 of this document provides a copy of the French Decision. Appendix 2 of this document is a copy of the draft product label as proposed by the applicant. Appendix 3 of this document is a copy of the letter(s) of Access. 1 DETAILS OF THE APPLICATION 1.1 Application background The present registration report concerns the evaluation of BAYER S.A.S. s application to market ABILIS 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 after approval of the active substance of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Tebuconazole 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 921/2014 of 25 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance tebuconazole. Specific provisions of Commission Implementing 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 tebuconazole, 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 dietary exposure of consumers to the tebuconazole (triazole) metabolites; the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures
Page 4 of 26 such as buffer zones, where appropriate. The Member States concerned shall request the submission of further information to confirm the risk assessment for birds and mammals. They shall ensure that the notifier at whose request tebuconazole has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. The following regulation was not published at the date of dossier s submission. Specific provisions of Commission Implementing Regulation (EU) No 921/2014 were as follows : PART A Only uses as fungicide and plant growth regulator 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 tebuconazole, 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 dietary exposure of consumers to the tebuconazole (triazole) metabolites; the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole; the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. An EFSA conclusion is available (EFSA Scientific Report (2008) 176, 1-109;EFSA Journal 2014; 12(1): 3485). A Review Report is available (SANCO/171/08 rev. 1, 9 September 2008 [Inclusion]; SANCO/171/08 rev. 2, 11 July 2014 [Conditions of approval]). Please note that the dossier was submitted prior to the publications in 2014. Triadimenol 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 Commission Implementing 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 triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing
Page 5 of 26 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 presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure; the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission : further information on the specification; information to further address the risk assessment for birds and mammals. information to further address the risk of endocrine disrupting effects on fish. They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. An EFSA conclusion is available (EFSA Scientific Report (2008) 177, 1-134). A Review Report is available (SANCO/10690/2012 rev 2, 1 June 2012). 1.3 Regulatory approach The present application (2012-0806) was evaluated in France by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 1 in the context of the voluntary 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 Southern zone. 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 2006 3 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 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 s assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/2009 4, implementing regulations, Directive 2008/125/EC 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) 1 2 3 4 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 http://www.legifrance.gouv.fr/affichtexte.do?cidtexte=jorftext000000425570 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
Page 6 of 26 No 546/2011 5, and are expressed as acceptable or not acceptable in accordance with those criteria. Finally, the French Order of 26 March 2014 6 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 ABILIS, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7. 1.5 Letter(s) of Access Bayer CropScience is the notifier for the active substances tebuconazole and triadimenol and therefore is the company owning and submitting a complete set of data, resulting in the listing of the active substances onto Annex I of Directive 91/414/EEC. Thus no letter of access is required as Bayer CropScience is the owner of all studies. Furthermore, Bayer CropScience is a member of the task force for the triazole metabolite derivatives and has access to all the data generated on these metabolites. 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) ABILIS (product code: TBZ+TDL EC 300; Specification No. 102000013167) Authorisation number 9700442 Function Applicant Composition Formulation type (code) Packaging Fungicide BAYER S.A.S. 225 g/l tebuconazole 75 g/l triadimenol Emulsifiable concentrate [Code: EC] Bottle of 1 L: High Density Polyethylene (HDPE) alternative Coextruded High density polyethylene (HDPE-COEX) with an internal barrier layer made of polyamide (PA) or EVOH 5 6 7 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 http://www.legifrance.gouv.fr/eli/arrete/2014/3/26/agrg1407093a/jo SANCO document guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs : SANCO/ 7525/VI/95 - rev.9
Page 7 of 26 2.2 Classification and labelling 2.2.1 Classification and labelling under Directive 99/45/EC Not applicable after 1st June 2015. 2.2.2 Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Acute toxicity (oral), Hazard Category 4 Acute toxicity (inhal.), Hazard Category 4 Serious eye damage/eye irritation, Hazard Category 1 Reproductive toxicity, Hazard Category 2 Environmental hazards Hazard pictograms Hazardous to the aquatic environment Chronic Hazard, Category 2 Signal word Danger Hazard statements H302 Harmful if swallowed. H332 H318 H361d H411 Harmful if inhaled Causes serious eye damage Suspected of damaging the unborn child Toxic to aquatic life with long lasting effects. Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) For the P phrases, refer to the extant legislation - See Part C for justifications of the classification and labelling proposals. 2.2.3 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 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 (uses in wine grape only). 8 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. 253-1 of the rural code [that is, plant protection products/pesticides]
Page 8 of 26 2.2.4 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 : wine grape 21 days Due to the risk of resistance on powdery mildew, only two non-consecutive applications per season and on the whole diseases complex are recommended. The label must reflect the conditions of authorisation. 9 10 11 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. 253-1 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.
Page 9 of 26 2.3 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. Those uses are then granted in France. 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: 2016-01-29 PPP (product name/code) ABILIS/(TBZ+TDL EC 300) active substance 1 tebuconazole [TBZ] active substance 2 triadimenol [TDL] Formulation type: Conc. of a.s. 1: Conc. of a.s. 2: Emulsifiable concentrate (EC) 225 g/l 75 g/l Applicant: Zone(s): BAYER S.A.S. southern professional use non-professional use Verified by MS: yes TBZ = tebuconazole TDL = triadimenol Crop (a) MS or Country Product Name F, G or I (b) Pests or group of pests controlled (c) Form, type (d-f) Formul. Conc. of A.S. (g/l) (i) Method kind (f-h) applic. growth stage & season (j) applic. No min-max (k) Spray interval (day) Applic. rate per treatment g as/hl min-max Water L/ha min-max applic. rate / treatment g AS /ha max PHI (days) (l) remarks (m) Wine Grape France ABILIS F GUIGBI, PSPZTR, UNCINE EC TBZ 225 TDL 75 Spraying BBCH 53-85 1-2 12-14 50-500 TBZ 56.25 TDL 18.75 21 0,25 L product/ha Acceptable 2 non-consecutive applications per year on wine grapes to control the whole diseases complex 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 3-8263-3152-4), 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
Page 10 of 26
Page 11 of 26 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 3.1.1 Physical and chemical properties The product TBZ+TDL EC 300 (ABILIS) is an emulsifiable concentrate (EC). All studies have been performed in accordance with the current requirements. The appearance of the formulation is yellow clear liquid with chemical odor. It is not explosive and has no oxidising properties. It has a self-ignition temperature higher than 365 C and a flash point of 105 C. In aqueous solution at 1 %, its ph is 5.8 at room temperature. Stability data indicate a shelf life of at least 2 years at ambient temperature (HDPE/EVOH and HDPE/PA). Its technical characteristics are acceptable for a EC formulation. The formulation is not classified for the physico-chemical aspect. 3.1.2 Methods of analysis 3.1.2.1 Analytical method for the formulation Analytical methods for the determination of active substances in the formulation are available and validated. 3.1.2.2 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 triadimenol and tebuconazole in plants (acidic), soil, water (surface and drinking) and air. Analytical methods for the determination of residues in foodstuffs of animal origin are not necessary as the proposed use (grape) is not used in animal feeding. For triadimenol, based on the regulatory definition for monitoring in plants, a confirmatory method is required for the determination of triadimefon in acidic matrices. 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. 3.1.3 Mammalian Toxicology 3.1.3.1 Acute Toxicity TBZ+TDL EC 300 (ABILIS), containing 225 g/l tebuconazole and 75 g/l triadimenol, moderately toxic after acute oral and inhalative administration and non-toxic after dermal application to rats. It is slightly irritating to the skin (classification not triggered) but severely irritating to the eyes of rabbits. It is not sensitising in the Local Lymph Node Assay. Considering the classification of the non-active ingredients, the active substance and the results of acute toxicity studies, TBZ+TDL EC 300 requires the toxicological classification shown in Section 2.2. 3.1.3.2 Operator Exposure Endpoint used in assessment for TBZ+TDL EC 300 Triadimenol Systemic AOEL : 0.05 mg/kg bw/d Dermal absorption of undiluted product: 17 % Dermal absorption of diluted product: 100 %
Page 12 of 26 Tebuconazole Systemic AOEL : 0.03 mg/kg bw/d Dermal absorption of undiluted product: 13 % Dermal absorption of diluted product: 55 % Operator exposure was modelled using the German BBA model. Parameters used in operator exposure assessment Crop Equipment Application rate Grape Tractor-mounted/trailed boom sprayer: hydraulic nozzles 0.25 L/ha (56.25 g tebuconazole/ha, 18.75 g triadimenol/ha) According to the model calculations, it can be concluded that the risk for the operator using TBZ+TDL EC 300 on grape crops is acceptable with the use of personal protective equipment and with a working coverall (90 % protection factor). Refer to the Decision in Appendix 1 for the details of personal protective equipment. 3.1.3.3 Bystander Exposure Bystander exposure was assessed according to the EUROPOEM II for the use of TBZ+TDL EC 300. It is concluded that there is no undue risk for the bystander after incidental short-term exposure to TBZ+TDL EC 300. Respiratory exposure of nearby residents is calculated to be less than 0.01 % of the ADI of tebuconazole. 3.1.3.4 Worker Exposure Workers may have to enter treated areas after treatment for crop harvesting activities, therefore estimation of worker exposure was calculated according to EUROPOEM II. It is concluded that, without taking into account a re-entry period, there is no unacceptable risk anticipated for the worker if coverall and gloves are worn, when re-entering crops treated with TBZ+TDL EC 300. Refer to the Decision in Appendix 1 for the details of personal protective equipment. 3.1.4 Residues and Consumer Exposure 3.1.4.1 Residues Primary crop metabolisms were sufficiently investigated to define residue of tebuconazole and triadimenol for enforcement and risk assessment purposes in the crops under consideration. Regarding the magnitude of residues in wine grape, a sufficient number of residue trials are available to support the intended GAPs in France. These data allowed estimation of the expected residue concentrations in the relevant plant commodities, and to confirm that no MRL exceedence will result from the intended uses. The effects of processing on the nature of triadimenol and tebuconazole residues have been investigated. As the intended crops are perennial, no data on residues in succeeding crops are necessary. Moreover, as wine grape is not fed to livestock, no data on residues in animal commodities are necessary. According to the available data, no specific mitigation measures should apply.
Page 13 of 26 3.1.4.2 Consumer exposure The toxicological profiles of tebuconazole and triadimenol were evaluated at EU level, which resulted in the proposal of an ADI (0.03 mg/kg bw/d for tebuconazole, 0.05 mg/kg bw/d for triadimenol) and an ARfD (0.03 mg/kg bw for tebuconazole, 0.05 mg/kg bw for triadimenol) that were considered in the framework of this evaluation. Chronic and acute consumer exposures resulting from the uses proposed in the framework of this application were calculated. Based on EFSA PRIMo (rev2), chronic and acute exposures were considered acceptable for all groups of consumers. 3.1.5 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 tebuconazole, triadimenol 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 PECsoil and PECsw for the active substances and their metabolites are used for the ecotoxicological risk assessment. PECgw for tebuconazole, triadimenol and their relevant metabolites do not exceed the trigger of 0.1 µg/l. Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses. Different active substances of the triazole family may be applied to the same plot. As the 1,2,4-triazole metabolite is common to most of these substances, it cannot be excluded that the regulatory value of 0,1 μg/l may be exceeded. To ensure compliance with the regulatory threshold value of 1,2,4-triazole in groundwater, all authorisation holders of triazole-based products must put in place specific monitoring for this metabolite within 24 months. 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: There are no specific implications for labelling resulting from environmental assessment. 3.1.6 Ecotoxicology The ecotoxicological risk assessment of the formulation TBZ+TDL EC 300 (ABILIS) was performed according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review for active substances and their metabolites were used for the intended use patterns. In cases where deviations from the EU agreed endpoints were considered appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. Based on the guidance documents, the risks for birds, mammals, bees and other non-target arthropods, earthworms and other soil macro-organisms, micro-organisms and non-target plants are acceptable for the intended uses. The risk to aquatic organisms following exposure to tebuconazole, triadimenol and their metabolites after applications of TBZ+TDL EC 300 could be considered acceptable with 5-metre spray drift buffer.
Page 14 of 26 3.1.7 Efficacy The product complies with the Uniform Principles. Considering the data submitted: The efficacy of the preparation ABILIS (TBZ+TDL EC 300) is considered satisfactory. The selectivity of the preparation ABILIS is considered satisfactory. The risk of negative impact (on yield, quality, transformation processes, adjacent crops) is considered negligible. The risk of resistance developing or appearing is considered high on powdery mildew. So, only two non-consecutive applications per season and per year are recommended. Management measures were established and a monitoring of efficacy failure will be implemented by the applicant and report any potential change in terms of resistance to the relevant authorities. On black-rot and rot-brenner, resistance risk is considered low. 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 3.4.1 Post-authorisation monitoring All authorisation holders of triazole-containing products must put in place dedicated monitoring for the relevant metabolite 1,2,4- triazole in groundwater within 24 months. Monitoring for the resistance of powdery mildew in grape crops must be put in place. Any new information likely to change the risk assessment must be submitted to the competent authorities. 3.4.2 Post-authorisation data requirements The French Decision requests the submission of post-authorisation confirmatory pieces of information within 24 months regarding: - A confirmatory method is required for the determination of triadimefon in acidic matrices (typing error in the French decision). - The results of the monitoring for metabolite 1,2,4- triazole in groundwater. - Efficacy data with regard to the use against powdery mildew under characterised resistance situation to DMI. 3.4.3 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 2.2.1 (or 2.2.2), 2.2.3 and 2.2.4. The label shall reflect the detailed conditions stipulated in the Decision.
Page 15 of 26 Appendix 1 Copy of the French Decision
Page 16 of 26
Page 17 of 26
Page 18 of 26
Page 19 of 26
Page 20 of 26
Page 21 of 26
Page 22 of 26 Appendix 2 Copy of the draft product label as proposed by the applicant
Page 23 of 26
Page 24 of 26
Page 25 of 26
Page 26 of 26 Appendix 3 Letter(s) of Access Not applicable.