OSSETIA (FF-020) Page 1 of 24. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 24 REGISTRATION REPORT Risk Management Product code: FF-20 TRADE NAME: OSSETIA Active Substance(s): Diflufenican, 500 g/kg COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation) Applicant: ROTAM Agrochemical Europe Ltd

2 Page 2 of 24 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 Summary of the evaluation 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 24 PART A Risk Management The company ROTAM Agrochemical Europe Ltd has requested marketing authorisation in France for the product, containing 500 g/kg diflufenican for use as a herbicide. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C, and where appropriate the addenda for France. The information, data and assessments provided in Registration Report, Part B include assessment of further data or information as required at national registration by the EU peer review. It also includes assessment of data and information relating to where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of have been made using endpoints agreed in the EU peer review of diflufenican. 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 ROTAM Agrochemical Europe Ltd. s application to market in France as a herbicide (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 Diflufenican 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 herbicide 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 diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate. An EFSA conclusion is available (EFSA Scientific Report (2007) 122, 1-84.). A Review Report is available (SANCO/3782/08 rev. 1, 14 March 2008).

4 Page 4 of Regulatory approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 1 in the context of the zonal procedure for all Member States of the Southern zone, taking into account the worst-case uses ( risk envelope approach ) 2 the highest application rates over the. When risk mitigation measures were necessary, they are adapted to the situation in France. According to the French law and procedures, specific conditions of use are set out in the Decision letter. The French Order of 12 September provides that: - unless formally stated in the product authorisation, the pre harvest interval (PHI) is at least three days; - unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is five metres; - unless formally stated in the product authorisation, the minimum re-entry period is six hours for field uses and eight hours for indoor uses. Drift reduction measures such as low-drift nozzles are not considered within the decision-making process in France. However, drift buffer zones may be reduced under some circumstances as explained in Appendix 3 of the abovementioned French Order. The current document (RR) based on Anses s assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/2009 4, implementing regulations and French regulations. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A of the RR presents a summary of essential scientific points upon which recommendations are based and is not intended to show the assessment in detail. The conclusions relating to the acceptability of risk are based on the criteria indicated in Regulation (EU) No 546/2011 5, and are expressed as acceptable or not acceptable in accordance with those criteria. Finally, the French Order of 26 March provides that: - an authorisation granted for a reference crop applies also for linked crops, unless formally stated in the Decision - the reference and linked crops are defined in Appendix 1 of that French Order. Thus, at French national level, possible extrapolation of submitted data and the corresponding assessment from reference crops to linked ones are undertaken even if not clearly requested by the applicant in their drr, and a conclusion is reached on the acceptability of the intended uses on those linked crops. The aim of this Order, mainly based on the EU document on residue data extrapolation 7 is to supply minor crops with registered plant protection products. Therefore the GAP table (Section 2.3) and Decision may include uses on crops not originally requested by the applicant. The Decision, as reproduced in Appendix 1, takes also into account national provisions, including national mitigation measures French Food Safety Agency, Afssa, before 1 July 2010 SANCO document risk envelope approach, European Commission (14 March 2011). Guidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach ; SANCO/11244/2011 rev. 5 REGULATION (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC COMMISSION REGULATION (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products SANCO document guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs : SANCO/ 7525/VI/95 - rev.9

5 Page 5 of 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 equivalent studies to the original applicant s Annex II dossier. 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) herbicide ROTAM Agrochemical Europe Ltd 500 g/kg diflufenican Water dispersible granule (WG) Packaging High-density polyethylene (HDPE) bottles (0,8 L, 1 L, 2 L) 2.2 Classification and labelling High-density polyethylene (HDPE) containers (5 L) Classification and labelling under Directive 99/45/EC Not applicable after 1st June Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards - Environmental hazards Hazardous to the aquatic environment Acute Hazard, Category 1 Hazardous to the aquatic environment Chronic Hazard, Category 1 Hazard pictograms Signal word Hazard statements Precautionary statements Warning H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. For the P phrases, refer to the extant legislation

6 Page 6 of 24 Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) - 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 2 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, do not apply to artificially drained soils with clay content higher than or equal to 45 % for uses on winter cereals (autumn and spring applications). To protect aquatic organisms, respect a non-sprayed vegetative buffer zone of 20 metres including a 20-metres permanent planted strip to surface water bodies for uses in winter and spring cereals Other phrases linked to the preparation Wear suitable personal protective equipment 8 : refer to the Decision in Appendix 1 for the details Re-entry period 9 : 6 hours Pre-harvest interval 10 : Wheat, triticale, barley and spelt: F- Application must be made at growth stage BBCH 32 at the latest Rye, F- pre-emergence application Other mitigation measures: - After harvest, only winter cereals can be sown during following autumn, - After crop failure, only cereals can be grown as replacement crop. The label must reflect the conditions of authorisation 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.

7 Page 7 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 OSSETIA /FF-20 Diflufenican Formulation type: Conc. of as 1: GAP rev. 1, date: 2016-November-21 < WG> 500 g/kg Applicant: Zone(s): Verified by MS: Field of use: ROTAM Agrochemical Europe Ltd southern yes herbicide professional use non professional use Crop and/ or situation (a) Zone Product code F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment Type (d-f) Conc. of as (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg product/ha min max water L/ha min max kg as/ha min max PHI (days) (l) Remarks: (m) w/s.wheat, Durum wheat triticale and spelt w/s.barley FR FF-020 F Dicotyledonous weeds WG 500 g/kg Foliar spray Pre-emergence to BBCH 32 (autumn-spring) max. 1 - max max 0.12 F Acceptable Rye FR FF-020 F Dicotyledonous weeds WG 500 g/kg Foliar spray Pre-emergence (autumn) max. 1 - max max 0.12 F Acceptable

8 Page 8 of 24 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

9 Page 9 of 24 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 water dispersible granule (WG). 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 light brown granular formulation, with characteristic odour. It is not explosive and has no oxidizing properties. The product is not flammable. It has no auto-flammable at ambient temperature. In aqueous solution (1%), it has a ph value 7.2 at 21.3 C. There is no effect of low and high temperature on the stability of the formulation, since after 14 days at 54 C, neither the active ingredient content nor the technical properties were changed. The stability data indicates a shelf life of at least 2 years at ambient temperature when stored in HDPE. Its technical characteristics are acceptable for a water dispersible granule (WG) formulation. The formulation is not classified for the physico-chemical aspect Methods of analysis Analytical method for the determination of active substance in the formulation is available and validated. As the active substance does not contain relevant impurity, no analytical method is required. Analytical methods are available in the monograph/this dossier and validated for the determination of residues of diflufenican in plants (wheat, barley, rye, triticale), food of animal origin, soil, water (surface and drinking) and air. The active substance is neither toxic nor very toxic hence no analytical method is required for the determination of residues in biological fluids Mammalian Toxicology Acute Toxicity containing 500 g/kg diflufenican has a low acute oral, inhalational and dermal toxicity. It is not irritating to the rabbit skin or eye and is not a skin sensitizer Operator Exposure Operator exposure was assessed against the AOEL agreed in the EU review of diflufenican. Endpoint used in assessment for FH-020 Diflufenican Systemic AOEL 0.11 mg/kg bw/d Dermal absorption of undiluted and diluted product 100 % Operator exposure was modeled using the German BBA model:

10 Page 10 of 24 Parameters used in operator exposure assessment Crop Equipment Application rate Wheat Tractor mounted / trailed boom sprayer: hydraulic nozzles 0.24 kg product/ha (120 g diflufénican/ha) 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. The following personal protective equipment is recommended by applicant: For mixing/loading - Nitrile gloves certified EN 374-3; - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons, Category III Type PB3 worn over the coverall proposed above; For application - Downward spraying If application with tractor with cab - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Disposable nitrile gloves certified EN 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 application with tractor without cab - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Disposable nitrile gloves certified EN in the case of an intervention on application equipment; For equipment cleaning - Nitrile gloves certified EN 374-3; - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons, Category III Type PB3 worn over the coverall proposed above Bystander Exposure Bystander exposure has been assessed according to the EUROPOEM II for the use of FH-020. It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to Worker Exposure is used as herbicidal treatment on several crops where there is no need to re-enter the treated area after application. Worker exposure is considered not relevant. If the worker would have performed different tasks on the treated crops: - Nitrile gloves certified EN 374-3; - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment Residues and Consumer Exposure Overall conclusion The data available are considered sufficient for risk assessment. An exceedance of the current MRL of 0.02 mg/kg on cereals for diflufenican as laid down in Reg. (EU) 396/2005 is not expected. The chronic and the short-term intakes of diflufenican residues are unlikely to present a public health concern. As far as consumer health protection is concerned, France agrees with the authorisation of the intended use(s).

11 Page 11 of 24 According to available data, no specific mitigation measures should apply. Data gaps Not necessary Summary of the evaluation Summary for diflufenican Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg 603/2015 Chronic risk for consumers identified? Acute risk for consumers identified? Comments / Wheat Yes Yes Yes Yes Yes not necessary / Barley Yes Yes Yes Yes Yes not necessary / Triticale Yes Yes Yes Yes Yes No not necessary / Rye Yes Yes Yes Yes Yes not necessary * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 Summary for FH-020 (OSSETIA) Crop PHI for FH-020 (OSSETIA) proposed by applicant PHI/ Withholding period* sufficiently supported for Diflufenican PHI for FH-020 (OSSETIA) proposed by zrms zrms Comments (if different PHI proposed) Wheat Barley Triticale Rye F (from pre-emergence to BBCH 32) F (from pre-emergence to BBCH 32) F (at pre-emergence) F (at pre-emergence) Yes Yes Yes F (from preemergence to BBCH 32) Triticale is considered as Wheat NR: not relevant * Purpose of withholding period to be specified ** F: PHI is defined by the application stage at last treatment (time elapsing between last treatment and harvest of the crop) Environmental fate and behaviour The fate and behaviour in the environment of the formulation have been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review were used to calculate PECs for the active substance and its 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 diflufenican and its metabolites in soil, surface water and groundwater have been assessed according to FOCUS guidance documents, with standard FOCUS scenarios to obtain outputs from the FOCUS models, and the endpoints established in the EU review or agreed in the assessment based on new data provided. Yes

12 Page 12 of 24 PEC soil and PECsw derived for the active substance and its metabolites are used for the eco-toxicological risk assessment, and mitigation measures are proposed. PECgw for diflufenican and its metabolites do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO/221/ Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses. Based on vapour pressure, information on volatilisation from plants and soil, and DT50 calculation, no significant contamination of the air compartment is expected for the intended uses Ecotoxicology Effects on Terrestrial Vertebrates The TER values calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk and 5 for long-term risk for the active substance, indicating that the risk to birds and mammals is acceptable following the use of diflufenican according to the proposed use pattern. For diflufenican (log Pow > 3), a risk assessment for fish-eating and earthworm-eating birds and mammals was conducted and long-term TER values are above the trigger of 5. The risks due to bioaccumulation of diflufenican via the food chain are then acceptable. The risks for the puddle scenario of the drinking water were considered acceptable. Therefore, treatment with in accordance with the proposed use patterns in cereals poses an acceptable risk to birds and mammals Effects on Aquatic Species The most sensitive organism is algae for diflufenican. Based on the EU refinement approach, the risk to aquatic nontarget organisms following treatment with is acceptable when a non-sprayed vegetative buffer zone of 20 m including a 20-metres permanent planted strip is applied for winter and spring cereals. A restriction for not using in winter cereals on artificial drained soil with clay content higher than or equal to 45 % for uses on winter cereals (autumn and spring applications) is also proposed (only the scenario D2 is concerned) Effects on Bees and Other Arthropod Species Overall, the calculated HQ values for the active substance and the product are less than 50. The risk for honeybees is then considered acceptable when is applied according to the intended application rates Effects on Earthworms and Other Soil Macro-organisms No unacceptable acute or reproductive risk to earthworms is indicated using active substance, formulation and metabolites data. It is therefore concluded that use of according to GAP is not expected to result in an unacceptable acute or long-term risk to earthworms. The TER values are above 5 for Folsomia candida and Hypoaspis aculeifer, showing an acceptable risk for soil macro-organisms after exposure to diflufenican and. Based on a field litter-bag study, diflufenican, applied at the recommended application rates, would not adversely affect the processes affecting decomposition of indigenous organic material under field conditions Effects on Non-target plants 11 Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council directive 91/414/EEC. SANCO/221/2000-rev10-final, 25 February 2003.

13 Page 13 of 24 Under field conditions the use of on cereals poses no unacceptable risk to non-target plants without drift mitigation measure Effects on Soil Non-target Micro-organisms The risk of to soil micro-organisms was evaluated by comparison of no-effect concentrations derived from laboratory tests with the active substance and metabolites with PEC soil. All no effect levels exceed the relevant PEC soil values by a factor of at least 3, indicating that does not pose an unacceptable risk to soil micro-organisms Efficacy The efficacy of is considered satisfactory against dicotyledonous weeds at the target rate of 0.24 kg product/ha (120 g a.s./ha). However, because of low number trials in Mediterranean zone, CMS should decide at national level if it is sufficient. The selectivity of is considered acceptable. An extrapolation has been done to allow pre-emergence application on rye and triticale through trials carried out in barley and wheat. The risk of negative impact (yield, quality, transformation processes, propagation, adjacent and succeeding crops) is considered acceptable taking into account the recommendations for succeeding crops. The applicant relate to data not yet provided about succeeding crops which are required post-autorisation. The risk of resistance development or appearance 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 Post-authorisation monitoring No further information is required Post-authorisation data requirements The French Decision requests the submission of post-authorisation confirmatory pieces of information within 6 months regarding: - Phytotoxicity data on succeeding crops should be provided 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.

14 Page 14 of 24 Appendix 1 Copy of the French Decision

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20 Page 20 of 24 Appendix 2 Copy of the draft product label as proposed by the applicant

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24 Page 24 of 24 Appendix 3 Letter(s) of Access Not applicable.