TREBON 30 EC Page 1 of 27. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 27 REGISTRATION REPORT Risk Management Product code: - Product name(s): Active Substance(s): Etofenprox, g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing extension of use) Date: 02/12/2015

2 Page 2 of 27 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 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 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 27 PART A Risk Management The company CERTIS EUROPE B.V. has requested marketing authorisation in France for the product TREBON 30 EC (etofenprox EC), containing g/l etofenprox for use as an insecticide. 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 TREBON 30 EC where that data have not been considered in the EU review process. Otherwise assessments for the safe use of have been made using endpoints agreed in the EU review of etofenprox. 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 CERTIS EUROPE B.V. s application to market TREBON 30 EC in France as an insecticide (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 label extension of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Etofenprox 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. Specific provisions of regulation were as follows : PART A Only uses as insecticide 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 etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, EN Official Journal of the European Union L 153/139 Number Common name, identification numbers IUPAC name Purity (1) Date of approval Expiration of approval

4 Page 4 of 27 Specific provisions the protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate. The Member States concerned shall: ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification, the submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study). They shall ensure that the notifiers provide such studies to the Commission by 31 December An EFSA conclusion is available (EFSA Scientific Report (2008) 213, 1-131). A Review Report is available (SANCO/148/08 final, 22 October 2009). An assessment of confirmatory data by the RMS is available on CIRCABC (2014). 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 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 meters ; - 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 acceptability of risk are based on the criteria indicated in Regulation (EU) No546/2011 5, and are expressed as acceptable or unacceptable in accordance with those criteria 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 27 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, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access The applicant has provided the supporting data in Document K; the ownership of the data is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7. A copy of the letter(s) of access is reproduced in, Appendix 3. 2 DETAILS OF THE AUTHORISATION 2.1 Product Identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) Insecticide CERTIS EUROPE B.V g/l of etofenprox Emulsifiable concentrate [Code: EC] Packaging HDPE/adhesive/EVOH (1 L, 5 L) 2.2 Classification and Labelling Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Aspiration toxicity, cat; 1 Skin irritation cat. 2 Eye irritation cat. 2 Specific target organ toxicity Signal Exposure cat.3 Reproductive toxicity effect on or via lactation Environmental hazards Aquatic acute category 1 Aquatic chronic category 1

6 Page 6 of 27 Hazard pictograms Signal word Danger Hazard statements H304 May be fatal if swallowed and enters airways H315 H319 H336 H362 H400 H410 Causes skin irritation Causes serious eye irritation May cause drowsiness or dizziness May cause harm to breast-fed children Very toxic to aquatic life Very 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 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 SPe 8 Do not contaminate water with the product or its container (Do not clean application equipment near surface water/avoid contamination via drains from farmyards and roads). To protect aquatic organisms, respect an unsprayed buffer zone of 50 meter 6 with 20 meter permanent planted strip to adjacent surface water bodies for uses on vines and do not apply more than 120g a.s./ha/an. To protect non-target arthropods respect an unsprayed buffer zone of 20 meter to non-agricultural land for uses on vines. Dangerous to bees/to protect bees and pollinating insects do not apply to crop plants when in flower/do not use where bees are actively foraging/ Do not apply when flowering weeds are present. 6 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]

7 Page 7 of Other phrases linked to the preparation Wear suitable personal protective equipment 7 : refer to the Decision in Appendix 1 for the details Re-entry period 8 : 24 hours Pre-harvest interval 9 : 14 days for vines Other mitigation measures: - The label may include the following recommendations: The label should include the following sentence: - The preparation contains etofenprox, it may cause paresthesia. According to the French arrêté du 9 novembre 2004, it should be mentioned on the label to avoid contact with skin. 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.

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. Crop and/ or situation (a) Zon e 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 as/hl min max water L/ha min max g as/ha min max PHI (days) (l) Remarks: (m) Vines FR TREBON 30 EC F Grape berry moths - Eupoecilia ambiguella / Clysia - Lobesia botrana EC g/l Foliar spray BBCH (April-September) 2 14 days Product rate : 0.4 L/ha Not acceptable Unacceptable risk for aquatic organisms in case of two applications even with a non-sprayed buffer zone of 50 m including a 20 m vegetated buffer strip. Vines FR TREBON 30 EC F Grape berry moths - Eupoecilia ambiguella / Clysia - Lobesia botrana EC g/l Foliar spray BBCH (April-September) Product rate : 0.4 L/ha Acceptable Based on refined assessments, the risk for aquatic organisms is acceptable for a single application with a nonsprayed buffer zone of 50 m including a 20 m vegetated buffer strip.

9 Page 9 of 27 Crop and/ or situation (a) Zon e 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 as/hl min max water L/ha min max g as/ha min max PHI (days) (l) Remarks: (m) Vines FR TREBON 30 EC Vines FR TREBON 30 EC Peach FR TREBON 30 EC Apricot FR TREBON 30 EC F F F F Leafhoppers - Scaphoideus titanus - Empoasca viti - Metcalfa pruinosa Leafhoppers - Scaphoideus titanus - Empoasca viti - Metcalfa pruinosa Oriental fruit moths - Cydia molesta Peach twig borer - Anarsia lineatella Leafhoppers Oriental fruit moths - Cydia molesta Peach twig borer - Anarsia lineatella EC g/l EC g/l EC g/l EC g/l Foliar spray Foliar spray Foliar spray Foliar spray BBCH (April-September) BBCH (April-September) BBCH (April August) BBCH (April August) 2 14 days Product rate : 0.3 L/ha Not acceptable Unacceptable risk to aquatic organisms for two applications even with a non-sprayed buffer zone of 50 m including a 20 m vegetated buffer strip Product rate : 0.3 L/ha Acceptable Based on refined assessments, the risk to aquatic organisms is acceptable for a single application with a nonsprayed buffer zone of 50 m including a 20 m vegetated buffer strip days Product rate : 0.6 L/ha 2 14 days Not acceptable Based on refined assessments, the risk to aquatic organisms is not acceptable for stone fruits even for one application with a non-sprayed buffer zone of 50 m including a 20 m vegetated buffer strip.

10 Page 10 of 27 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 an emulsifiable concentrate. All studies have been performed in accordance with the current requirements. The appearance of the formulation is an amber liquid with aromatic odour formulation. It is not explosive and has no oxidizing properties. It has a self-ignition temperature of 410 C and a flash point of 62 C. In aqueous solution (1%), its ph is 5.5 at 21 C. Stability data indicate a shelf life of at least 2 years at ambient temperature (HDPE/adhesive/EVOH). Its technical characteristics are acceptable for an emulsifiable formulation. Emulsion stability and re-emulsification is required after storage 14 days at 54 C. The formulation is classified H Methods of analysis Analytical method for the formulation Analytical methods for the determination of active substance and relevant impurity in the formulation are available and validated Analytical methods for residues Analytical methods are available in the monograph and validated for the determination of residues of etofenprox in plants (high oil content), soil, water (surface and drinking) and air. To update the dossier and to be in accordance with SANCO825/00/rev8.1, the following analytical methods are required: - A confirmatory method for the determination of etofenprox residues in acidic commodities. - A confirmatory method for the determination of etofenprox residues in soil and water. The active substance is neither toxic nor very toxic hence no analytical method is required for the determination of resides in biological fluids and tissues Mammalian Toxicology Acute Toxicity containing g/l etofenprox has a low toxicity in respect to acute oral, inhalation and dermal toxicity and is irritating to the rabbit skin and eye but, it is not a skin sensitizer Operator Exposure Summary of critical use patterns (worst cases): Crop Equipment Application rate Model Peach Tractor-mounted/trailed broadcast air assisted sprayer 0.6 L/ha (172.5 g as/ha) BBA Considering proposed uses, operator systemic exposure was estimated using the German BBA model: Crop Equipment PPE and/or working coverall % AOEL etofenprox Peach Tractor-mounted/trailed broadcast air assisted sprayer Working coverall and gloves during mixing/loading and application 14 % According to the model calculation, 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.

11 Page 11 of Bystander Exposure Bystander exposure was assessed according to EUROPOEM II. Exposure is estimated to 17 % of the AOEL of etofenprox. It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to TREBON 30 EC. zrms considers that resident exposure is not relevant for claimed uses Worker Exposure Workers may have to enter treated areas after treatment. Therefore, estimation of worker exposure was calculated according to EUROPOEM II. Exposure is estimated to 21 % of the AOEL of etofenprox with PPE. It is concluded that without taking into account a re-entry period, there is no unacceptable risk anticipated for workers wearing a working coverall and gloves, when re-entering crops treated with Residues and Consumer Exposure Residues Primary crop metabolisms were sufficiently investigated to define residue of etofenprox for enforcement and risk assessment in crops under consideration. Regarding the magnitude of residues in grapes and peaches, a sufficient number of residue trials are available to support the intended GAPs in Southern Europe. These data allowed confirming that no MRL exceedance will result from intended uses. The effect of industrial and/or household processing was investigated at EU level. Nevertheless, these processing factors were not taken into account to refine the consumer exposure. In the frame of this dossier, uses on perennial crops are intended (grapes and peaches). Thus, residues in succeeding crops do not have to be investigated. Studies for residues in representative succeeding crops are not necessary. For etofenprox, the residue data on grapes and peaches do not modify the dietary burden for beef, dairy cattle and pig. In etofenprox EU evaluation, the anticipated dietary burden of dairy and beef cattle was estimated on the basis of the uses of etofenprox on oilseed, cabbage and apple. Taking into account these uses, the trigger value was reached for dairy and beef cattle but is still not reached for poultry. In conclusion, the requested uses do not modify the theoretical maximum daily intake for animals. Considering animal metabolism study, animal feeding study, the dietary burden calculation and based on the intended uses, there is no risk for animal MRL to be exceeded Consumer exposure The toxicological profile of etofenprox was evaluated at EU level, which resulted in the proposal of an ADI (0.03 mg/kg) and an ARfD (1 mg/kg) that were considered in the frame of this evaluation. Chronic consumer exposure resulting from the uses proposed in the framework of this application was calculated for etofenprox. Based on EFSA PRIMo (rev2), chronic and acute exposures were considered as acceptable for all groups of consumers 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 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 etofenprox and its metabolites in soil, surface water and ground water 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 substance and its metabolites are used for the eco-toxicological risk

12 Page 12 of 27 assessment, and mitigation measures are proposed. PECgw for etofenprox and its metabolite alpha-co do not exceed the trigger of 0.1 µg/l. Therefore, no unacceptable risk of ground water 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 The risk assessment for birds and mammals shows that there is no significant acute or reproductive risk to avian or mammalian species from the application of to target crops according to the proposed GAP. The acute and long-term risk to birds and mammals from exposure to contaminated drinking water was assessed and is not considered to pose an unacceptable risk. Bioaccumulation and food chain behaviour to birds and mammals from consumption of earthworms and fish indicates acceptable risk. Based on refined assessments, it was concluded that the risk to aquatic organisms is acceptable for vines for a single application at a maximal rate of 120 g a.s./ha with a non-sprayed buffer zone of 50 meter including a 20 meter vegetated buffer strip and that risk to aquatic organisms is not acceptable for stone fruits even if a non-sprayed buffer zone of 50 m including a 20 m vegetated buffer strip is considered.. Etofenprox is of high acute contact and oral toxicity to honeybees. However, as the period of application is outside the flowering period, the exposure of bees is very limited and the risk is out of concern when is used according to the proposed GAP and when the following mitigation measures are respected «Dangerous to bees/to protect bees and pollinating insects do not apply to crop plants when in flower/do not use where bees are actively foraging/ Do not apply when flowering weeds are present... Extended laboratory studies were conducted with the two indicator species Typhlodromus pyri and Aphidius rhopalosiphi on natural substrates. The results demonstrate that the proposed application rates for are expected to cause adverse effects in the in-field environment to the sensitive indicator species, Aphidius rhopalosiphi, Typhlodromus pyri. Aged residue studies and full fauna field study in a meadow demonstrated that recovery would occur within season after treatment with. The off-field risks are acceptable when a buffer zone of 20 meters in peaches and vines is respected. The risk assessments for earthworms, demonstrated that no unacceptable effects would be anticipated to earthworms and other soil macro-organisms. Risks to non-target plants were found to be acceptable. Risk from metabolites were assessed and showed no unacceptable risks Efficacy The product complies with the Uniform Principles. Considering the data submitted: - The efficacy of is considered as satisfactory for use as insecticide on peach and apricot trees against oriental fruit moth and peach twig borer at 0.6 L/ha and on vines against leafhoppers at 0.3 L/ha and against grape berry moths at 0.4 L/ha. - No unacceptable negative impact on peach and apricot trees and on vines are expected following the use of in the recommended conditions of use. The risk of negative impact (yield, quality, transformation processes, propagation, succeeding crops, adjacent crops) is considered as acceptable. - The risk of resistance development or appearance is considered as low to medium and to manage the risk, a maximum of two applications per year is recommended against Oriental fruit moth, peach twig borer, vine moth and grape leafhopper with no more than one application per pest generation per year and a monitoring program on Eudemis susceptibility is claimed in post-authorisation. French label project: - Revise information on authorized uses: the use against leafhoppers on peach trees is not authorized. - Precise that it is recommended not to use the product on more than one pest generation per year.

13 Page 13 of Conclusions arising from French assessment For the intended uses on vines: Taking into account the above, an authorisation can be granted as proposed in Appendix 1 Copy of the product decision. For the intended uses on peach and apricot, the risk to aquatic organisms is not acceptable even when considering one application and mitigation measures such as a non-sprayed buffer zone of 50 meter including a 20 m vegetated buffer strip: Taking into account the above, an authorisation cannot be granted as proposed in Appendix 1 Copy of the product decision. 3.3 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 confirmatory monitoring within 2 years are needed regarding: - the sensitivity of populations of Eudemis. Any new information likely to change the risk assessment must be submitted to the competent authorities Post-authorisation data requirements Post-authorisation confirmatory pieces of information are needed (within 24 months) regarding: - A confirmatory method for the determination of etofenprox residues in acidic commodities Data gaps 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 27 Appendix 1 Copy of the French decision

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21 Page 21 of 27 Appendix 2 Copy of the draft product label as proposed by the applicant

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