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REGISTRATION REPORT Part A

Risk Management

Product name: FURY 10 EW Active Substance: zeta-cypermethrin 100 g/L

COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT

Applicant: Cheminova Deutschland GmbH & Co. KG Submission Date: 02/01/2014 Date: 17/08/2018

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Table of Contents

PART A – Risk Management 4 1 Details of the application 4 1.1 Application background 4 1.2 Annex I inclusion 4 1.3 Regulatory approach 5 2 Details of the authorisation 6 2.1 Product identity 6 2.2 Classification and labelling 6 2.3.2.2 Specific restrictions linked to the intended uses 9 2.3 Product uses 10 3 Risk management 12 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 12 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 12 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 12 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 12 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 12 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 12 The PPP is already registered in Germany according to Regulation (EU) No 1107/2009. 12 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 12 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 13 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 13 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 13 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 14 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 14 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 14 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 17 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 17 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 18 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 19 3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) 20 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 21 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 21

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3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 21 3.1.7 Efficacy (Part B, Section 7, Point 8) 23 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 24 Appendix 1 – Copy of the product authorisation 25 Appendix 2 – Copy of the product label 26 Appendix 3 – Letter of Access 27

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PART A – Risk Management This document describes the acceptable use conditions required for the registration of additional uses of FURY 10 EW containing zeta-cypermethrin in Germany.

The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 (except Section 2, 3 and 4) and where appropriate the addendum for Germany. There were no significant differences to the original product authorization from 2017. For this reason, no specific Part B, Section 2, 3 and 4 were drafted. Instead, it is referred to the original German assessment report of BfR. The information, data and assessments provided in Registration Report, Parts B includes 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 FURY 10 EW where that data has not been considered in the EU review. Otherwise assessments for the safe use of FURY 10 EW have been made using endpoints agreed in the EU review of zeta-cypermethrin.

This document describes the specific conditions of use and labelling required for Germany for the registration of FURY 10 EW.

Appendix 1 of this document provides a copy of the final product authorisation Germany.

Appendix 2 of this document is a copy of the approved product label for Germany The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again.

Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation. Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

1 Details of the application

1.1 Application background This application was submitted by FMC Chemical on 2 January 2014. Afterwards the application was transferred to Cheminova Deutschland GmbH & Co. KG.

The application was for extension of approval of FURY 10 EW, an emulsion, oil in water [EW] containing zeta-cypermethrin 100 g/L for use as an insecticide

1.2 Annex I inclusion

Zeta-cypermethrin (CAS No 52315-07-8, CIPAC No 733) is included in the Annex to Commission Implementing Regulation (EU) No 540/2011 containing the active substances approved for use in plant protection products under Regulation (EC) No 1107/2009 with the expiration of approval on 30 November 2019.

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According to general provisions applying to all substances listed in the Annex to Commission Implementing Regulation (EU) No 540/2011:

— for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;

— Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.

According to specific provisions in the parts A and B Annex to Regulation No 540/2011 on Zeta- cypermethrin (CAS No 52315-07-8):

PART A Only uses as insecticide may be authorised.

PART B In assessing applications to authorise plant protection products containing zeta- cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, — the protection of birds, aquatic organisms, bees, non-target arthropods and non- target soil macro- organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.

1.3 Regulatory approach To obtain approval of additional uses the product FURY 10 EW must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points.

This application was submitted in order to allow the registration of further uses of an already approved product in Germany in accordance with the above.

1.4 Data protection claims

Where data protection is being claimed regarding information supporting registration of Fury 10 EW, it is indicated in the reference list in Appendix 1 of the respective documents of the Registration Report.

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1.5 Letters of Access

The data not provided by the applicant and necessary to conduct the evaluation is out of protection, no access authorization is needed.

2 Details of the authorisation

2.1 Product identity

Product Name Fury 10 EW Authorisation Number 024222-00/01 (for re-registration) Function Insecticide Applicant Cheminova Deutschland GmbH Composition 100 g/L zeta-cypermethrin Formulation type Oil-in-water [Code: EW] Packaging 1 L to 20 L HDPE bottles; 20 L HDPE jerry can

2.2 Classification and labelling

2.2.1 Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:

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Hazard classes and categories: Acute Tox. 4, skin Sens. 1, Aquatic acute 1, Aquatic chronic 1 Hazard pictograms: GHS07 exclamation mark GHS09 Environment Signal word: Warning Hazard statements: H302 Harmful if swallowed. H317 May cause an allergic skin reaction. H332 Harmful if inhaled. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Precautionary statemtents: P101 If medical advice is needed, have product container or label at hand. P102 Keep out of reach of children. P264 Wash ... thoroughly after handling. P270 Do no eat, drink or smoke when using this product. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection. P302+P352 IF ON SKIN: Wash with plenty of soap and water. P308+P313 IF exposed or concerned: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash it before reuse. P391 Collect spillage. P501 Dispose of contents/container to ...

Special rule for labelling of PPP: EUH401 To avoid risks to man and the environment, comply with the instructions for use. EUH 208-0175 Contains zeta-cypermethrin. May produce allergic reactions. EUH 208-0196 Contains 5-chloro-2-methyl, mixture with 2-methyl-3(2H)-isothiazolone at the ratio of 3:1. May produce an allergic reaction. Further labelling statements under Regulation (EC) No 1272/2008: -

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2.2.2 Standard phrases under Regulation (EC) No 547/2011 None.

2.2.3 Other phrases notified under Regulation (EC) No 547/2011

2.2.3.1 Restrictions linked to the PPP The authorisation of the PPP is linked to the following conditions (mandatory labelling):

Human health protection SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB005 If medical advice is needed, have product container or label at hand. SB010 Keep out of children’s reach. SB111 Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection prod-ucts" of the Federal Office of Consumer Protection and Food Safety (www.bvl.bund.de) must be observed. SB166 Do not eat, drink or smoke when using this product. SB193 If the plant protection product comes into contact with skin (especially facial), it can cause burning or itching, without external signs of irritation. These effects must be regarded as a warning to avoid further exposure at all costs. If the symptoms do not disappear, or if they are joined by further symptoms, a doctor must be consulted. SF245-02 It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. SS110-1 Protective gloves (plant protection) must be worn when handling the undiluted product. SS206 Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. SS1201 Wear standard protective gloves (plant protection) when handling/applying the product. SS530 Wear face protection when handling the undiluted product. SS610 Wear a rubber apron when handling the undiluted product. Integrated pest management (IPM)/sustainable use NN3001 The product is classified as harmful for populations of relevant beneficial insects. NN3002 The product is classified as harmful for populations of relevant predatory mites and spiders. Ecosystem protection NW264 The product is toxic for fish and aquatic invertebrates. NW468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be

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dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. NB6621 The product is classified as hazardous to bees except when applied after the end of the daily bee flight until 11 p.m. on the crop to be treated (B2). At all other times, it may not be used on plants which are in flower or which are visited by bees; this also applies to weeds. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410.

The authorisation of the PPP is linked to the following conditions (voluntary labelling):

2.3.2.2 Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling): See 2.4 (Product uses)

Ecosystem protection NG405 Not to be used on drained surfaces. Use: 001 NW607-1 When applying the product on areas adjacent to surface waters - except only occasionally but including periodically water bearing surface waters - the product must be applied with equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*". Violations may be punished by fines of up to 50 000 EUR. 90 % – 15 m Use: 001 NT109 A buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). In addition, in an adjoining strip of at least 20 m, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 90 %. Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (field boundaries, hedges, groups of woody plants) are less than 3 m wide. A buffer zone of at least 5 m is also unnecessary if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures, or if evidence can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on agriculturally or horticulturally used areas. Use: 001

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2.3 Product uses GAP rev. 2, date: 2016-08-17 PPP (product name/code): Fury 10 EW Formulation type: EW (a, b) Active substance 1: Zeta-Cypermethrin Conc. of as 1: 100 g/l (c)

Applicant: Cheminova Deutschland GmbH Professional use: Zone(s): central (d) Non professional use: Verified by MS: yes

Field of use: insecticide 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of pests Application Application rate PHI Remarks: No. (e) state(s) or situation Fn, controlled (days) Fpn Method / Timing / Growth Max. number Min. interval kg or L product g or kg as/ha Water e.g. g (crop destination / G, (additionally: Kind stage of crop & a) per use between / ha L/ha safener/synergist per purpose of crop) Gn, developmental stages of season b) per crop/ applications a) max. rate per a) max. rate per ha Gpn the pest or pest group) season (days) appl. appl. min / (f) or b) max. total b) max. total max I rate per rate per crop/season crop/season 001 DE Wheat (TRZSS), F Aphids as virus vectors Spraying BBCH 12 - 51 a) 2 at least 7 a) 0.15 l/ha a) 15 g a.s./ha 200 - 28 NG405, NT109, Oats b) 2 days b) 0.3 l/ha b) 30 g a.s./ha 400 NW607-1 (90 % - 15 (AVESS), Barley apart m) (HORVX)

Remarks (a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (d) Select relevant table (b) Catalogue of pesticide formulation types and international coding system CropLife (e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be heading: International Technical Monograph n°2, 6th Edition Revised May 2008 given in column 1 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

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Remarks 1 Numeration necessary to allow references 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, columns: 2 Use official codes/nomenclatures of EU Member States Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the application use situation should be described (e.g. fumigation of a structure) 8 The maximum number of application possible under practical conditions of use must be 4 F: professional field use, Fn: non-professional field use, Fpn: professional and non- provided. professional field use, G: professional greenhouse use, Gn: non-professional 9 Minimum interval (in days) between applications of the same product greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of application empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the products. common names of the pest groups (e.g. biting and sucking insects, soil born insects, 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment foliar fungi, weeds) and the developmental stages of the pests and pest groups at the (usually g, kg or L product / ha). moment of application must be named. 12 If water volume range depends on application equipments (e.g. ULVA or LVA) it should be 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench mentioned under “application: method/kind”. Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - 13 PHI - minimum pre-harvest interval type of equipment used must be indicated. 14 Remarks may include: Extent of use/economic importance/restrictions

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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 (Part B, Section 1, Points 2 and 4) There is no change regarding the Section 1 of the Pat B of the Registration Report compared to the main application.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) There is no change regarding the Section 2 of the Part B of the Registration Report compared to the main application. Therefore no evaluation is necessary. Toluene and tar residues were considered as relevant impurities of zeta-cypermethrin. An appropriate methods of analysis for determining toluene in the formulated product is available. For the relevant impurity tar only an analytical method of tar in the technical material of the active substance used in the preparation is presented. The validation data are missing.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) See main application, no new data were provided.

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)

The PPP is already registered in Germany according to Regulation (EU) No 1107/2009. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected.

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) The German assessment body did not present an assessment report on operator exposure (Part B, Section 3, Point 7.1).

Fury 10 EW was the representative formulation in the EU review of zeta-cypermethrin. The acute toxicity studies for the Fury 10 EW were evaluated during the review and were considered adequate.

Fury 10 EW, containing 100 g/L zeta-cypermethrin, does not meet criteria for classification for acute dermal toxicity and is not irritating to the rabbit skin and eye. It has a moderate oral and inhalation acute toxicity and is a skin sensitizer in the guinea pig maximisation test. Taking into account all submitted data and the labelling of zeta-cypermethrin, Fury 10 EW should be labelled as H302 - Harmful if swallowed, H332 - Harmful if inhaled, and H317 - May cause an allergic skin reaction.

Please refer to the assessment of PL on Fury 10 EW (application number 024222-00/00).

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3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) The German assessment body did not present an assessment report on operator exposure (Part B, Section 3, Point 7.3). The estimates of PL indicate that application of plant protection product Fury 10 EW at the highest foreseen GAP, dose of 0.0375 kg a.s./ha, does not pose an unacceptable health risk for operators. Therefore, please refer to the assessment of PL on Fury 10 EW (application number 024222-00/00).

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) The German assessment body did not present an assessment report on bystander exposure (Part B, Section 3, Point 7.4). The estimates of PL indicate that application of plant protection product Fury 10 EW at the highest foreseen GAP, dose of 0.0375 kg a.s./ha, does not pose an unacceptable health risk for bystanders and residents, including adults and children. Therefore, please refer to the assessment of PL on Fury 10 EW (application number 024222-00/00).

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) The German assessment body did not present an assessment report on worker exposure (Part B, Section 3, Point 7.5).The estimates of PL on Fury 10 EW (application number 024222-00/00) indicate that application of plant protection product Fury 10 EW at the highest foreseen dose of 0.0375 kg a.s./ha does not pose an unacceptable systemic health risk for worker not wearing PPE entering the treated field for inspection or for harvesting crops. Therefore, please refer to the assessment of PL on Fury 10 EW (application number 024222-00/00).

Implications for labelling resulting from operator, worker, bystander assessments: Please refer to chapter 2.2.

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3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8)

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) The proposed uses of Fury 10 EW are within those supported for the EU MRL assessment. Residues of zeta-cypermethrin are not expected to exceed the respective EU MRL values for barley, oats and wheat. The German assessment body did not present a consolidated assessment report on Metabolism and Residues (Part B, Section 4). Please refer to the assessment of PL on Fury 10 EW (application number 024222-00/00).

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) The German assessment body did not present a consolidated assessment report on Metabolism and Residues (Part B, Section 4). Please refer to the assessment of PL on Fury 10 EW (application number 024222-00/00).

The estimated consumer intake levels do not exceed the EU agreed ADI of 0.04 mg/kg bw/day for zeta- cypermethrin. It can therefore be concluded that acceptable margins of safety exist for consumers.

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)

The following chapters summarise specific exposure assessment for soil and surface water and the specific risk assessment for groundwater for the authorisation of Fury 10 EW in its intended use in cereals (use No /01-001), as documented in detail in the core assessment performed in Germany. The evaluation is based on the core assessment of the main application by zRMS Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

No Crop/growth Application Number of applications, Application rate, Soil effective stage method / Minimum application cumulative application rate Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season) /01-001 Wheat Spraying / 2 x, 7 d, spring / summer zeta-cypermethrin zeta- (TRZSS), Oats Ackerbau 1. 25 % 2 x 15 = 30 cypermethrin (AVESS), (arable crops) 2. 25 % 1. 11,25 Barley 2. 11,25 (HORVX) / = 22,5 BBCH 12-51

Metabolites No new study on the fate and behaviour of zeta-cypermethrin or Fury 10 EW has been performed. Hence no potentially new metabolites need to be considered for environmental risk assessment.

The risk assessment for the metabolites DCVA and mPBAcid has already been performed for EU approval as well as in the core assessment by Poland, Part B, section 5 and 6. They are all classified as not relevant with respect to ecotoxicological concerns. Hence a national assessment of the metabolites is

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The data on the degradation in soil of zeta-cypermethrin and the metabolites are summarised in the following table: Compound Worst case Modelling DT50 Maximum % DT50 for (days) at 20ºC PECsoil (days) and pF2 Zeta-cypermethrin 24.24 15.1 - DCVA 26.8 5.8 25.7 mPBAcid 7 4.2 15.0

The data on the sorption in soil of zeta-cypermethrin and the metabolites are summarised in the following table: Compound KF, OC 1/n Zeta-cypermethrin 83826 0.928 DCVA 28.3 0.64 mPBAcid 151.7 0.66

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5)

For the intended use of the plant protection product Fury 10 EW PECsoil values were calculated for the active substance zeta-cypermethrin considering a soil depth of 1 cm. Due to the fast degradation of the active substance zeta-cypermethrin in soil (DT90 < 365 d, SFO, field data) the accumulation potential of zeta-cypermethrin does not need to be considered. PECsoil calculations were performed considering the application rate and plant interception values for each individual use.

Details are given in Part B National Addendum-Germany, Section5, chapter 5.5.

Maximum PECsoil values are 1.364 mg/kg and 0.1364 mg/kg for the formulation Fury 10 EW and the active substance zeta-cypermethrin, respectively. The results for PECsoil for the active substance were used for the ecotoxicological risk assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)

1. Direct leaching into groundwater A scenario covering the intended use of Fury 10 EW in cereals was used for PECgw modelling (2 x 15 g as/ha, 25 % interception). According to the results of the groundwater simulation with FOCUS-PELMO, a groundwater contamination of the active substance zeta-cypermethrin in concentrations > 0.1 µg/L is not expected for the intended use. For the metabolites DCVA and mBPA of zeta-cypermethrin groundwater concentrations > 0.1 µg/L can as well be excluded.

For details see Part B, National Addendum-Germany, Section 5, chapter 5.7.1.

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Consequences for authorisation: None. Specific additional risk mitigation measures are not required.

2. Ground water contamination by bank filtration due to surface water exposure via run-off and drainage Groundwater contamination by bank filtration due to surface run-off and drainage of the active substance zeta-cypermethrin as well as the metabolites DCVA and mBPA into the adjacent ditch estimated by the model EXPOSIT 3.0 correspond to < 0.1µg/L.

For details see Part B, National Addendum-Germany, Section 5, chapter 5.7.2.

Consequences for authorisation: None. Specific additional risk mitigation measures are not required.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)

For the intended use of the plant protection product Fury 10 EW PECsw values were calculated for the active substance zeta-cypermethrin considering the two routes of entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately.

The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzelmeier. The vapour pressure at 20 °C of the active substance zeta-cypermethrin is < 10-5 Pa. Hence the active substance zeta-cypermethrin is regarded as non-volatile. Therefore exposure of surface water by the active substance zeta-cypermethrin due to volatilisation with subsequent deposition does not need to be considered.

The concentration of the active substance zeta-cypermethrin in adjacent ditch due to surface run-off and drainage was calculated using the model EXPOSIT 3.0.

Details are given in Part B, National Addendum-Germany, Section 5, chapter 5.6 and Section 6, chapter 6.5.

Maximum PECSW values for zeta-cypermethrin are 0.139 µg as/L and 0.01 µg as/L for the entry pathways spraydrift and drainage, respectively. The results for PECSW for the active substances were used for the ecotoxicological risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9)

The vapour pressure of the active substance zeta-cypermethrin is < 10-5 Pa, therefore it is considered not volatile and volatilisation and subsequent deposition is not considered in risk assessment. Calculation of PECAir is considered not necessary.

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Implications for labelling resulting from environmental fate assessment: (Phrase Rxx should be added to the label)

Active substance and formulation are considered not to be readily biodegradable in the sense of the CLP regulation.

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) The following chapters summarise the ecotoxicological risk assessment for non-target organisms for the authorisation of Fury 10 EW in its intended use in cereals (use No /01-001), as documented in detail in the core assessment performed in Germany. The evaluation is based on the core assessment of the main application by zRMS Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

No Crop/growth Application Number of applications, Application rate, Soil effective stage method / Minimum application cumulative application rate Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season) /01-001 Wheat Spraying / 2 x, 7 d, spring / summer zeta-cypermethrin zeta- (TRZSS), Oats Ackerbau 1. 25 % 2 x 15 = 30 cypermethrin (AVESS), (arable crops) 2. 25 % 1. 11,25 Barley 2. 11,25 (HORVX) / = 22,5 BBCH 12-51

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

Birds The risk assessment to birds was performed in accordance with the recommendation of EFSA Guidance Document on Risk Assessment for Birds & Mammals 2009. The relevant endpoints for the risk assessment for acute and long-term effects are LD50 > 5124 mg as/kg bw (Anas platyrhynchos) and NOEC = 2.5 mg as/kg bw/d (Colinus virginianus), respectively.

There is no potential of risk for wildlife birds resulting from acute and long-term exposure (including assessment of effects of secondary poisoning) to the active substance zeta-cypermethrin following use of Fury 10 EW in compliance with GAP. For details see Part B national addendum, Section 6.2.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

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Terrestrial vertebrates (other than birds) The risk assessment to mammals was performed in accordance with the recommendation of EFSA Guidance Document on Risk Assessment for Birds & Mammals 2009. The relevant endpoints for the risk assessment for acute and long-term effects are LD50 = 86 mg as/kg bw (rat) and NOEC = 5.9 mg as/kg bw/d (rat), respectively.

There is no potential of risk for wildlife mammals resulting from acute and long-term exposure (including assessment of effects of secondary poisoning) to the active substance zeta-cypermethrin following use of Fury 10 EW in compliance with GAP. For details see Part B national addendum, Section 6.3.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) For authorisation in Germany, exposure assessment of surface water considers the two routes of entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to allow for deriving risk mitigation measures separately for each entry route. Hence, aquatic risk assessment differs from those in the core assessment.

The relevant endpoints for effects on fish in acute and long-term tests are HC5 = 0.507 µg as/L (SSD for

LC50 for 7 species) and NOEC = 0.0385 µg as/L (full life cycle test with Pimephales promelas), respectively. The relevant endpoints for effects on aquatic invertebrates in acute and long-term tests are

EC50 = 0.0013 µg as/L (Gammarus pulex) and NOEC = 0.01 µg as/L (Daphnia magna), respectively. The relevant endpoint for effects on algae is ErC50 = 160 µg as/L (Pseudokirchneriella subcapitata). For the refined risk assessment for aquatic invertebrates, based on the results of outdoor mesocosm studies, the relevant endpoint is NOEC = 0.024 µg as/L in combination with assessment factor 6 (single application) or 18 (multiple application). RACinvertebrates are thus 0.004 µg as/L and 0.0013 µg as/L for single and multiple application pattern, respectively.

Based on the calculated concentrations of zeta-cypermethrin in surface water (EVA 3, EXPOSIT 3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to zeta-cypermethrin according to the GAP of the formulation Fury 10 EW achieve the acceptability criterion TER ≥ 1, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2 for long-term effects. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended uses of Fury 10 EW provided that additional specific risk mitigation measures are in place.

For the mitigation with regard to entry pathway spraydrift it is necessary to set untreated buffer zones and the use of drift-reducing application technique (label restriction NW607-1). For the uses with a soil effective application rate of 12 g/ha or more application on drained surfaces must be excluded (label restriction NG405). The product Fury 10 EW as well as the active substance zeta-cypermethrin is very toxic to the aquatic environment. Therefore, additional labelling with risk phrases (NW264) and safety

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For details see Part B national addendum, Section 6.5.

Consequences for authorisation: For the authorisation of the plant protection product Fury 10 EW the following labelling and conditions of use are mandatory:

Required Labelling Fury 10 EW NW264 (aquatic community RAC = 0.0013 µg a.s./L)

Conditions for use Fury 10 EW NW468 Use No. /01-001 NW607-1 (90 % - 15 m) Use No. /01-001 NG405

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees In the honey bee risk assessment for the main application it was concluded that Fury 10 EW (used up to 0.15 L/ha in cereals) has to be classified as hazardous to bees except when applied after the end of the daily bee flight until 11 p.m. on the crop to be treated. At all other times, it may not be used on plants which are in flower or which are visited by bees; this also applies to weeds. Since the recommended application rate does not exceed this rate no further risk assessment is required.

Consequences for authorisation:

NB6621: The product is classified as hazardous to bees except when applied after the end of the daily bee flight until 11 p.m. on the crop to be treated (B2). At all other times, it may not be used on plants which are in flower or which are visited by bees; this also applies to weeds. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410.

Other non-target arthropods The evaluation of the risk for non-target arthropods was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev.2 (final), October 17, 2002), and in consideration of the recommendations of the guidance document ESCORT 2, adapted to the national evaluation approach (TER calculation).

The relevant endpoint for the off-crop risk assessment for non-target arthropods is derived from an extended laboratory test with Typhlodromus pyri (3 D exposure on bean plants): LR50 = 0.085 g as/ha.

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A complete first tier risk assessment is not possible, as studies with four sensitive indicator species are not available. However, as tier 2 studies with Aphidius rhopalosiphi and Typhlodromus pyri are available, a risk assessment has been conducted using the most sensitive endpoint for T. pyri and indicating an acceptable off-field risk considering risk mitigation measures. For the mitigation with regard to entry pathway spraydrift it is necessary to set an untreated buffer zone of 5 m width and the use of 90 % drift- reducing application technique (label restriction NT109). For details see Part B national addendum, Section 6.7.

An unacceptable risk for solitary wild bees due to the exposure with residues of zeta-cypermethrin via spray drift and pollen/nectar exposition cannot be excluded according to the screening step. No higher tier evaluation has been conducted. The risk mitigation measures stipulated for the protection of honey bees (NB6621) allowing an application only after the end of the daily bee flight until 11 p.m. are considered to be appropriate also for the protection of solitary wild bees.

Consequences for authorisation: For the authorisation of the plant protection product Fury 10 EW the following labelling and conditions of use are mandatory:

Conditions for use Use No. /01-001 NT109 (90 % - 5 m)

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) Based on the predicted concentrations of zeta-cypermethrin/Fury 10 EW in soil, the TER values describing the acute risk for earthworms following exposure to zeta-cypermethrin/Fury 10 EW according to the GAP achieve the acceptability criterion TER ≥ 10 according to Commission Regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for earthworms due to the intended use of Fury 10 EW in cereals.

The results of the field study indicate a high risk for other soil meso-organisms (Collembolae). The TER values describing the acute risk for collembolans following exposure to zeta-cypermethrin/Fury 10 EW according to the GAP achieve the acceptability criterion TER ≥ 1 according to Commission Regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.

Due to conformity to the decision at EU level an acceptable risk for collembolans is concluded. However, based on the shortcomings of the study, a field study with collembolans lasting one year is required to be submitted after authorisation.

For details see Part B national addendum, Section 6.8.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

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3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) Based on the predicted concentrations of zeta-cypermethrin/Fury 10 EW in soil, an acceptable risk with regard to effects on organic matter breakdown due to the intended use of Fury 10 EW in cereals is indicated.

For details see Part B national addendum, Section 6.8 and 6.9.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Based on the predicted concentrations of zeta-cypermethrin/Fury 10 EW in soil, the risk to soil microbial processes following exposure to Fury 10 EW according to the GAP is considered to be acceptable according to Commission Regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.

For details see Part B national addendum, Section 6.9.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) The applicant has submitted data on the effect of Fury 10 EW on non-target terrestrial plants. According to the insecticidal effect of the formulation these effect values are substantially higher than those effects determined for non-target arthropods, which are therefore relevant for the risk assessment for terrestrial biocoenosis. A quantitative risk assessment for non-target terrestrial plants is for that reason not conducted in this national addendum.

The risk for non-target plants following exposure to Fury 10 EW according to the GAP is considered to be acceptable.

For details see Part B national addendum, Section 6.10.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

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Implications for labelling resulting from ecotoxicological assessment:

Classification and labelling according to Regulation (EC) No 1272/2008 Hazard classes and categories: Aquatic Acute 1, Aquatic Chronic 1 Hazard pictograms: GHS09 environment Signal word: Warning Hazard statements: H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Precautionary statemtents: P273 Avoid release to the environment. P391 Collect spillage. P501 Dispose of contents/container to ...

Labelling requirements according to § 36 (3) PflSchG

NW264 The product is toxic for fish and aquatic invertebrates. NW468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. NT109 A buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). In addition, in an adjoining strip of at Use: 001 least 20 m, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 90 %. Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (field boundaries, hedges, groups of woody plants) are less than 3 m wide. A buffer zone of at least 5 m is also unnecessary if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures, or if evidence can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on agriculturally or horticulturally used areas. NG405 Not to be used on drained surfaces.

Use: 001

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NW607-1 When applying the product on areas adjacent to surface waters - except only occasionally but including periodically water bearing surface waters - the product must be applied with equipment Use: 001 which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*". Violations may be punished by fines of up to 50 000 EUR. 90 % – 15 m

3.1.7 Efficacy (Part B, Section 7, Point 8) All the data regarding the efficacy of the product have been submitted. These data demonstrate that Fury 10 EW fulfils all criteria for the authorization of preparations described in Directive 97/57/EC (Uniform Principles, Annex VI to Directive 91/414/EEC). No phytotoxicity, effects on neighbouring or following crops were observed.

Beneficials: On the basis of field tests, effects > 50% are expected for populations of relevant taxa of beneficial insects, predatory mites and spiders, when Fury 10 EW is applied according to the recommended use pattern (i.e. 2 x 0.15 L/ha) to cereals.

NN3001 The product is classified as harmful for populations of relevant beneficial insects. NN3002 The product is classified as harmful for populations of relevant predatory mites and spiders.

3.2 Conclusions

With respect to physical, chemical and technical properties of the formulation an authorisation can be granted. With respect to analytical methods (formulation and residues) an authorisation can be granted.

With respect to toxicology, residues and consumer protection an authorisation can be granted.

With respect to efficacy/ sustainability an authorisation can be granted.

Harmful effects on ground water consequent to the intended use of the product Fury 10 EW have not to be apprehended. Regarding effects on non-target organisms an authorisation can be granted provided that specific additional risk mitigation measures are set to protect aquatic organisms and terrestrial non-target arthropods.

An authorisation can be granted.

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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

The following information is required in order to obtain (a prolongation of) the authorisation:

Annex III point Data

KIIA1 5.2.4 Validation study of the analytical determination of the relevant impurity tar in the formulated product is deemed to be necessary.

KIIIA1 10.6.8 Field study on effects on collembolans

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Appendix 1 – Copy of the product authorisation

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Appendix 2 – Copy of the product label The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again.

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Appendix 3 – Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

Applicant (Cheminova Deutschland GmbH) Evaluator BVL / DE Date: August 2018

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Susanne Luttmann Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referentin

TELEFON +49 (0)531 299-3612 Cheminova Deutschland GmbH TELEFAX +49 (0)531 299-3002 & Co. KG E-MAIL [email protected] Stader Elbstraße 26 IHR ZEICHEN 21683 Stade IHRE NACHRICHT VOM

AKTENZEICHEN 200.22100.024222-00/01.96958 (bitte bei Antwort angeben)

DATUM 10. Oktober 2018

ZV1 024222-00/01 FURY 10 EW Zulassungsverfahren für Pflanzenschutzmittel Ergänzungsbescheid

Die Zulassung des oben genannten Pflanzenschutzmittels

mit dem Wirkstoff: 100 g/l zeta-Cypermethrin

Zulassungsnummer: 024222-00

Versuchsbezeichnungen: CHD-56701-I-1-EW

Antrag vom: 2. Januar 2014

ändere ich wie folgt:

Zusätzliche Anwendungsgebiete bzw. Anwendungen

Die Zulassung wird um folgende Anwendungsgebiete bzw. Anwendungen erweitert (siehe Anlage 1):

Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 024222-00/01-001 Blattläuse als Virus- Hafer, Gerste, Weizen In Beständen zur Korn- vektoren erzeugung, ausgenom- men Grünkern BVL_FO_05_2476_200_V1.6

Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de SEITE 2 VON 6

Festgesetzte Anwendungsbestimmungen

Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 84 des Gesetzes vom 18. Juli 2016 (BGBl. I S. 1666), festgesetzt: Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.

Auflagen

Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden: Siehe Anlage 1, jeweils unter Nr. 2.

Vorbehalt

Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.

Abgelehnte Anwendungsgebiete bzw. Anwendungen

Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine -

Weitere Hinweise und Bemerkungen

Naturhaushalt Es besteht weiterhin die unter Punkt 3. meines Schreibens 200.22100.024222-00/01.96958 vom 13. Februar 2017 mitgeteilte zulassungsbegleitende Nachforderung zu KIIIA1 10.6.8 (Freilanduntersuchung zu Auswirkungen des Pflanzenschutzmittels auf Boden-Mesoorganis- men (Collembolen)). Hinsichtlich der geforderten Abstimmung des anzuwendenden Studien- designs hatten Sie sich in Ihren zwischenzeitlichen Nachlieferungen allerdings bislang nicht geäußert. Ich weise ausdrücklich darauf hin, dass vor der Durchführung der Untersuchungen diese Abstimmung unter Einbeziehung der zuständigen Bewertungsbehörde, dem Umwelt- bundesamt, durchgeführt werden sollte, damit aussagefähige Ergebnisse erzielt werden.

Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid. BVL_FO_05_2476_200_V1.6 SEITE 3 VON 6

Rechtsbehelfsbelehrung

Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur Niederschrift einzulegen.

Mit freundlichen Grüßen im Auftrag

gez. Dr. Achim Holzmann

Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.

Anlage BVL_FO_05_2476_200_V1.6 SEITE 4 VON 6

Anlage 1 zugelassene Anwendung: 024222-00/01-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Blattläuse als Virusvektoren Pflanzen/-erzeugnisse/Objekte: Hafer, Gerste, Weizen Verwendungszweck: In Beständen zur Kornerzeugung, ausgenommen Grünkern

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Ackerbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 12 bis 51 Anwendungszeitpunkt: Nach dem Auflaufen Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Erläuterungen Anzahl Behandlungen: zeitlicher Abstand der Behandlungen mindestens 7 Tage Anwendungstechnik: spritzen Aufwand: - 0,15 l/ha in 200 bis 400 l Wasser/ha

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 28 Tage Freiland: Hafer

28 Tage Freiland: Gerste

28 Tage Freiland: Weizen

3 Anwendungsbezogene Anwendungsbestimmungen (NG405) Keine Anwendung auf drainierten Flächen. Begründung: Der im Pflanzenschutzmittel Fury 10 EW enthaltene Wirkstoff Zeta-Cypermethrin weist ein hohes Potenzial für Einträge in Oberflächengewässer über den Pfad Drainage auf. Ausge- BVL_FO_05_2476_200_V1.6 SEITE 5 VON 6

hend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wasserlöslich- keit = 0,0387 mg/L; DT50 Boden = 24,24 d; KOC = 83826) und einer Berechnung der zu erwartenden Einträge mit dem Modell Exposit 3.01 sind nach dem Stand der wissenschaftli- chen Erkenntnisse die Vorgaben der Anwendungsbestimmung NG405 einzuhalten, um einen ausreichenden Schutz von aquatischen Lebensgemeinschaften vor Rückständen des Wirk- stoffs Zeta-Cypermethrin (RAC = 1,3 ng/L) zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen (Sektion 5, Kapitel 7 / Sektion 6, Kapitel 5).

(NT109) Bei der Anwendung des Mittels muss ein Abstand von mindestens 5 m zu angrenzenden Flä- chen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege und Plätze) eingehalten werden. Zusätzlich muss die Anwendung in einer darauf folgenden Breite von mindestens 20 m mit einem verlustmindernden Gerät erfolgen, das in das Ver- zeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 90 % eingetragen ist. Bei der Anwendung des Mittels ist weder der Einsatz verlustmindernder Technik noch die Einhaltung eines Abstandes von mindestens 5 m erforderlich, wenn die Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind. Bei der Anwendung des Mittels ist ferner die Einhaltung eines Abstandes von mindestens 5 m nicht erforderlich, wenn die Anwendung des Mittels in einem Gebiet erfolgt, das von der Biologischen Bundesanstalt im "Verzeichnis der regionalisierten Kleinstrukturanteile" vom 7. Februar 2002 (Bundesanzeiger Nr. 70a vom 13. April 2002) in der jeweils geltenden Fassung, als Agrarlandschaft mit einem ausreichenden Anteil an Kleinstrukturen ausgewiesen worden ist oder angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) nachweislich auf landwirtschaftlich oder gärtnerisch genutzten Flächen angelegt worden sind. Begründung: Das Pflanzenschutzmittel Fury 10 EW bzw. der darin enthaltene Wirkstoff Zeta-Cypermethrin weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielarthropoden auf. Bewer- tungsbestimmend ist hier die ER50 von 0,085 g a.s./ha für Typhlodromus pyri im erweiterten Labortest (3D). Ausgehend von den geltenden Modellen zur Abdrift sowie zur Verflüchtigung von Zielflächen und anschließender Deposition (hier: EVA 3) und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissenschaftlichen Erkenntnisse die Anwendungsbestimmung NT109 erforderlich, um einen ausreichenden Schutz von terrestrischen Nichtzielarthropoden in Saumbiotopen vor Auswirkungen des Mittels Fury 10 EW zu gewährleisten. Weitere Infor- mationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen (Sektion 6, Kapitel 7).

(NW607-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - aus- genommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mit einem Gerät erfolgen, das in das Verzeichnis "Verlustmin- dernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils gel- tenden Fassung eingetragen ist. Dabei sind, in Abhängigkeit von den unten aufgeführten BVL_FO_05_2476_200_V1.6 SEITE 6 VON 6

Abdriftminderungsklassen der verwendeten Geräte, die im Folgenden genannten Abstände zu Oberflächengewässern einzuhalten. Für die mit "*" gekennzeichneten Abdriftminderungs- klassen ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in jedem Fall zu beachten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden. reduzierter Abstand: 90 % 15 m Begründung: Das Pflanzenschutzmittel Fury 10 EW bzw. der darin enthaltene Wirkstoff Zeta-Cypermethrin weist ein hohes Gefährdungspotenzial für aquatische Organismen, insbesondere aquatische Lebensgemeinschaften auf. Bewertungsbestimmend ist hier die RAC für aquatische Biozö- nosen von 4,0 ng/L bei einfacher Applikation, bzw. von 1,3 ng/L bei mehrfacher Applikation. Ausgehend von den geltenden Modellen zur Abdrift sowie zur Verflüchtigung von Zielflächen und anschließender Deposition (hier: EVA 3) und einem Sicherheitsfaktor von 6 bzw. 18 ist nach dem Stand der wissenschaftlichen Erkenntnisse die Anwendungsbestimmung NW607- 1 erforderlich, um einen ausreichenden Schutz von Gewässerorganismen vor Einträgen des Mittels Fury 10 EW in Oberflächengewässer zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen (Sektion 6, Kapitel 5). BVL_FO_05_2476_200_V1.6 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 1 of 15 Germany

REGISTRATION REPORT Part B

Section 1: Identity, physical and chemical properties, other information Detailed summary of the risk assessment

Product code: Fury 10 EW (Fury 10 EW) Active Substance: Zeta-cypermethrin 100 g/L

Central Zone Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Cheminova Deutschland GmbH & Co. KG Submission Date: 02/01/2014 Date: August 2018

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 2 of 15 Germany

Table of Contents

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT ...... 7

IIIA 1.1 Applicant ...... 7

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s) ...... 7

IIIA 1.2.1 Manufacturer(s) of the preparation ...... 7

IIIA 1.2.2 Manufacturer(s) of the active substance(s) ...... 7

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s) ...... 7

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation ...... 7

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation ...... 8

IIIA 1.4.1 Content of active substance and formulants ...... 8

IIIA 1.4.2 Certified limits of each component ...... 8

IIIA 1.4.3 Common names and code numbers for the active substance(s) ...... 8

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function...... 8

IIIA 1.4.5 Formulation process ...... 8

IIIA 1.4.5.1 Description of formulation process ...... 8

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern ...... 8

IIIA 1.5 Type of Preparation and Code ...... 9

IIIA 1.6 Function ...... 9

IIIA 1.7 Other/Special Studies ...... 9

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT ...... 10

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT ...... 10

IIIA 3.1 Field of Use ...... 10

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 3 of 15 Germany

IIIA 3.2 Nature of the Effects on Harmful Organisms ...... 10

IIIA 3.3 Details of Intended Use ...... 10

IIIA 3.3.1 Details of existing and intended uses ...... 10

IIIA 3.3.2 Details of harmful organisms against which protection is afforded ...... 10

IIIA 3.3.3 Effects achieved ...... 10

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) ...... 11

IIIA 3.5 Concentration of the Active Substance in the Material Used ...... 11

IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent ...... 11

IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection ...... 11

IIIA 3.7.1 Maximum number of applications and their timings ...... 11

IIIA 3.7.2 Growth stages of crops or plants to be protected ...... 11

IIIA 3.7.3 Development stages of the harmful organism concerned ...... 11

IIIA 3.7.4 Duration of protection afforded by each application ...... 11

IIIA 3.7.5 Duration of protection afforded by the maximum number of applications ...... 11

IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops ...... 11

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops ...... 11

IIIA 3.8.2 Limitations on choice of succeeding crops ...... 11

IIIA 3.8.3 Description of damage to rotational crops ...... 11

IIIA 3.9 Proposed Instructions for Use as Printed on Labels ...... 12

IIIA 3.10 Other/Special Studies ...... 12

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT ...... 12

IIIA 11 FURTHER INFORMATION...... 12

Appendix 2: Critical Uses – justification and GAP tables ...... 13

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 4 of 15 Germany

Introduction

This document reviews the identity, physical and chemical properties and other information for the plant protection product Fury 100 EW. Fury 10 EW is the alternative trade name Fury 100 EW. This formulation contains the active substance (a.s.) zeta-cypermethrin (CAS No 52315-07-8, CIPAC No 733), which was included into Annex I of Directive 91/414/EEC under Commission Directive 2009/37/EC of 23rd April 2009 and was approved under Regulation (EC) 1107/2009 by Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 with the expiration of approval on 30 November 2019.

According to general provisions applying to all substances listed in the Annex to Commission Implementing Regulation (EU) No 540/2011:

— for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account; — Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.

According to specific provisions in Part A and B of the Annex to Commission Implementing Regulation (EU) No 540/2011 for zeta-cypermethrin:

PART A Only uses as insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing zeta- cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. 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 zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, — the protection of birds, aquatic organisms, bees, non-target arthropods and non- target soil macro- organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest. The Regulation specifies: Minimum purity: 850 g/kg The impurities content: toluene: max 2 g/kg

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 5 of 15 Germany tars: max 12.5 g/kg

A full assessment according to uniform principles is provided, which demonstrates that the product is safe for sale and use.

These concerns are not related to physic-chemical properties and thus not relevant for this section. These concerns have been addressed within the current submission in the corresponding sections. The protection of operators is addressed in Part B, Section 3 and the protection of birds, aquatic organisms, bees, non- target arthropods and non-target soil macro-organisms is addressed in Part B, Section 6.

In addition, concerned Member States shall also request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest. This information was submitted to the RMS (Belgium) by this deadline.

The review established a minimum purity for the active substance of not less than 850 g/kg with a maximum content of 2 g/kg and 12.5 g/kg determined for the manufacturing impurities toluene and tars, respectively. Further information on the specification of the active substance was considered necessary in relation to the inclusion of zeta-cypermethrin in Annex I. This information was submitted and evaluated in line with the Guidance Document on the Finalisation of the Reference Specification for Technical Active Substances after the Peer Review1. On 9 July 2010 the Standing Committee on the Food Chain and Animal Health has taken note of the revision of the review report after the finalisation of the reference specification. Since this evaluation there has been no change in the manufacturing site or specification of the active substance.

Fury 10 EW was the representative formulation during the Annex I inclusion and has already been evaluated in the context of the EU review according to Uniform Principles (EFSA Scientific Report (2008) 196, 1 - 119).

The EFSA Scientific Report (2008) 196, 1 - 119 (Conclusions on pesticide peer review: Conclusion regarding the peer review of the pesticide risk assessment of the active substance zeta-cypermethrin), the EC review report for zeta-cypermethrin (SANCO/142/08 final rev 1, 9 July 20102) as well as the DAR for zeta-cypermethrin (November 2006) and the Final addendum to the DAR for zeta-cypermethrin (September, 2008) are considered to provide the relevant review information or a reference to where such information can be found. Where relevant, each chapter will begin with a table providing the EU endpoints to be used in this evaluation. The following table provides the EU endpoints to be used in the evaluation.

EU End-points Active Substance End-Point EU agreed endpoints SANCO/142/08 final rev 1, 9 July 2010

1 Doc. SANCO/6075/2009 rev 3, July 2009 2 On 9 July 2010 the Standing Committee on the Food Chain and Animal Health has taken note of the revision of the review report after the finalisation of the reference specification referred to in point 7 of this report (cf. Infra).

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 6 of 15 Germany

850 g/kg (minimum purity) Purity of active substance Cis/trans-ratio should be in the range 55/45 to 45/55 Toluene – impurity 2 g/kg (maximum content)

Tars - impurity 12.5 g/kg (maximum content)

Where appropriate this document refers to the conclusions of the EU review of zeta-cypermethrin. This will be where: − the active substance data is relied upon in the risk assessment of the formulation; or when − the EU review concluded that additional data/information should be considered at national re- registration.

Appendix 2 of this document is the table of intended uses for Fury 100 EW.

Information on the detailed composition of Fury 100 EW can be found in the confidential dossier of the main application (Registration Report - Part C).

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 7 of 15 Germany

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT

IIIA 1.1 Applicant Name: FMC Chemical s.p.r.l. Address: Boulevard de la Plaine, 9/3 B-1050 Brussels Belgium

Contact: Nancy Hilton Telephone number: +32 2 645 95 38 Fax: +32 2 645 9655 E-mail: [email protected]

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s)

IIIA 1.2.1 Manufacturer(s) of the preparation Information relating to the plant locations is confidential information and any relevant details can be found in the main application.

IIIA 1.2.2 Manufacturer(s) of the active substance(s) Information relating to the plant locations is confidential information and any relevant details can be found in Part C of the main application.

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s) zeta-Cypermethrin min. 850 g/kg

Relevant impurities: Toluene max. 2 g/kg Tars max. 12.5 g/kg

Information relating to the impurities is confidential information and any relevant details can be found in Part C of the main application.

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation The formulation is known by a number of different trade names but all are identical to the representative formulation considered for Annex I inclusion.

Trade name: Fury 10 EW; Fury 100 EW

Alternative trade names: Minuet® 10 EW Minuet® 100 EW Manufacturers code number: 6242-NPF

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 8 of 15 Germany

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation

IIIA 1.4.1 Content of active substance and formulants Fury 10 EW was the representative formulation during the Annex I inclusion and has already been evaluated in the context of the EU review according to Uniform Principles (EFSA Scientific Report (2008) 196, 1 - 119).

Pure active substance Content of pure active substance: 100 g/L Limits: 90.0 – 110.0 g/L

Technical active substance w Content of technical active substance 117.6 g/L 11.8% /v At minimum purity of 85.0%: w Limits: 105.8 – 129.4 g/L 10.6 – 12.4 % /v

Formulants CONFIDENTIAL information – data provided separately (Part C of the main application).

IIIA 1.4.2 Certified limits of each component This is not an EC data requirement/ not required by Directive 91/414/EEC and Reg. (EC) 1107/2009.

IIIA 1.4.3 Common names and code numbers for the active substance(s) Data Point Type Name/Code Number 1.4.3.1 ISO common name Zeta-cypermethrin 1.4.3.2 CAS No. 52315-07-8 1.4.3.2 EINECS No. 257-842-9 1.4.3.2 CIPAC No. 733 1.4.3.2 ELINCS Not allocated 1.4.3.3 Salt, ester anion or cation The active substance is not present in the present formulation in the form of a salt, ester, anion or cation.

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function. CONFIDENTIAL information - data provided separately (Part C of the main application).

IIIA 1.4.5 Formulation process

IIIA 1.4.5.1 Description of formulation process This is not an EC data requirement/ not required by Directive 91/414/ EEC and Reg. (EC) 1107/2009.

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern CONFIDENTIAL information - data provided separately (Part C of the main application).

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment (Fury 10 EW) Page 9 of 15 Germany

IIIA 1.5 Type of Preparation and Code Type: Oil in water emulsion [Code: EW]

IIIA 1.6 Function Insecticide

IIIA 1.7 Other/Special Studies This is not required by Directive 91/414/EEC and Reg. (EC) 1107/2009.

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment Page 10 of 15

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT No new data submitted. Please refer to the main application.

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT

IIIA 3.1 Field of Use Agricultural and horticultural insecticide.

IIIA 3.2 Nature of the Effects on Harmful Organisms Zeta-cypermethrin acts as a contact and feeding insecticide, controlling insects by contact and stomach poison activity. Zeta-cypermethrin is not absorbed by plant foliage. As a pyrethroid, zeta-cypermethrin is a nerve poison, interacting with the sodium/potassium channels in membranes of the stimuli conduction system causing a train of impulses rather than a single impulse which results in paralysis and ultimately death of the insect. Zeta-cypermethrin belongs to Mode of Action Group 3A (IRAC MoA classification scheme 2010).

IIIA 3.3 Details of Intended Use

IIIA 3.3.1 Details of existing and intended uses Intended uses for the Central zone are summarised in:

Report: KIIIA1 3.3.1/01, Brian Prince, 2012 Title: Registration Report. Section 7: Efficacy Data and Information. Detailed Summary. Product Code: Fury 10EW. Active Substance: zeta-cypermethrin EW 100g/l. Central Zone. Zonal Biological Assessment Dossier Document No.: Appendix 11 Guidelines: - GLP: -

For full details of the critical GAP for the Central zone please refer to Appendix 2 of this document.

IIIA 3.3.2 Details of harmful organisms against which protection is afforded Ceutorhynchus assimilis, Ceutorhynchus napi, Ceutorhynchus quadridens, Ceutorhynchus picitarsis, Dasineura brassicae, Meligethes aeneus, Psylliodes chrysocephala, Oulema spp., Psammotettix alienus, Sitobion avenae, Rhopalosiphum padi, Rhopalosiphum maidis, Sitodiplosis mosellana, Haplodiplosis marginata, Cydia nigricana, Acythrosiphum pisum, Contarinia pisi, Thrips angusticeps, Sitona lineatus, Bruchus rufimanus, Autographa gamma, Agrotis spp., Aphis fabae, Macrosiphum euphorbiae, Myzus persicae, Leptinotarsa decemlineata, Aphthona euphorbiae, Lobesia botrana, Eupoecilia ambiguella, Ostrinia nubilalis, Diabrotica virgifera and Tanymecus dilaticollis.

IIIA 3.3.3 Effects achieved Zeta-cypermethrin acts as a contact and feeding insecticide, controlling insects (both adults and larvae) by contact and stomach poison activity. Zeta-cypermethrin is not absorbed by plant foliage.

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment Page 11 of 15

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) For full details of all uses please refer to the GAP Table (Appendix 2).

IIIA 3.5 Concentration of the Active Substance in the Material Used Fury 10 EW contains 100 g/l zeta-cypermethrin.

IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent For full details of all uses please refer to the GAP Table (Appendix 2).

IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection

IIIA 3.7.1 Maximum number of applications and their timings For full details of all uses please refer to the GAP Table (Appendix 2).

IIIA 3.7.2 Growth stages of crops or plants to be protected For full details of all uses please refer to the GAP Table (Appendix 2).

IIIA 3.7.3 Development stages of the harmful organism concerned Zeta-cypermethrin acts as a contact and feeding insecticide, controlling insects (both adults and larvae) by contact and stomach poison activity.

IIIA 3.7.4 Duration of protection afforded by each application Zeta-cypermethrin has only limited persistence on foliage, such that between 7-14 days protection is afforded by each application to the range of pests listed in IIIA 3.3.2 (above). The majority of uses include the option for a repeat application to the crop/pest.

IIIA 3.7.5 Duration of protection afforded by the maximum number of applications Where zeta-cypermethrin has the option of up to two applications per crop/pest the maximum duration of protection afforded to the range of pests listed in IIIA 3.3.2 (above) is 14-28 days. Where a single application of 37.5 g a.s./ha is recommended against certain pests, the maximum duration of protection afforded is approximately 14-28 days.

IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops None.

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops None.

IIIA 3.8.2 Limitations on choice of succeeding crops None.

IIIA 3.8.3 Description of damage to rotational crops None.

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zone Core Assessment Page 12 of 15

IIIA 3.9 Proposed Instructions for Use as Printed on Labels Please refer to Registration Report – Part A, Appendix 2 for the relevant country.

IIIA 3.10 Other/Special Studies This is not required by Directive 91/414/EEC and Reg. (EC) 1107/2009.

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT No new data submitted. Please refer to the main application.

IIIA 11 FURTHER INFORMATION No new data submitted. Please refer to the main application.

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zoneo Core Assessment Page 13 of 15f Germany

Appendix 2: Critical Uses – justification and GAP tables

Critical Uses – justification and GAP tables for the Central Zone GAP rev. , date: year-month-day PPP (product name/code) Fury 100 EW Formulation type: EW active substance 1 Zeta-cypermethrin Conc. of as 1: 100 g/L active substance 2 - Conc. of as 2: - active substance - Conc. of as: -

safener - Conc. of safener: - synergist - Conc. of synergist: -

Applicant: FMC Chemical sprl professional use Zone(s): Central non professional use

Verified by MS: Y/N

1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number L product / ha kg as/ha Water L/ha e.g. safener/synergist per ha (crop destination / I (additionally: Kind stage of crop & (min. interval a) max. rate per purpose of crop) developmental stages of season between appl. a) max. rate min / max e.g. recommended or mandatory tank applications) mixtures the pest or pest group) b) max. total rate per appl. a) per use per crop/season b) max. total rate per b) per crop/ crop/season season 1 DE, PL, Wheat, barley and oats F Oulema melanopus Convention BBCH 09 - 85 a) 2 a) 0.150 a) 0.015 200 / 400 28 UK, CZ, Psamottetix alienus al hydraulic (14 days) BE, HU, spray AT, SK Aphididae application b) 0.300 b) 0.030 Haplodiplosis marginata b) 2 (14 days)

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zoneo Core Assessment Page 14 of 15f Germany

2 DE, PL, Oilseed rape F Psylliodes chrysocephala Convention BBCH 09 - 69 a) 2 a) 0.100 a) 0.010 200 / 400 42 UK, CZ, Weevils: CEUTAS, al hydraulic (7 days) BE, HU, CEUTNA, CEUTQU, spray AT, SK application b) 0.200 b) 0.020 Meligethes aeneus b) 2 Dasyneura brassicae (7 days) 3 DE, UK, Peas (fresh) F Contarinia pisi Convention BBCH 08 – 85 a) 2 a) 0.150 a) 0.015 200 / 400 7 CZ, SK, Cydia nigricana al hydraulic (14 days) BE, AT spray Acythrosiphum pisum application b) 0.300 b) 0.030 b) 2 (14 days) 4 UK, SK, Peas (dry) F Contarinia pisi Convention BBCH 09 – 85 a) 2 a) 0.150 a) 0.015 200 / 400 14 BE Cydia nigricana al hydraulic (14 days) spray Acythrosiphum pisum application b) 0.300 b) 0.030 b) 2 (14 days) 5 PL, UK, Potato F Leptinotarsa decemlineata Convention BBCH 11 – 89 a) 2 a) 0.125 a) 0.0125 200 / 400 7 CZ, SK, Agrotis spp. al hydraulic (14 days) BE spray Aphididae application b) 0.25 b) 0.025 b) 2 (14 days) 6 UK, BE Sugar beet F Agrotis spp. Convention BBC 35 – 49 a) 2 a) 0.125 a) 0.0125 200 – 500 14 Autographa gamma al hydraulic (14 days) spray application b) 0.250 b) 0.025 b) 2 (14 days) 7 UK, BE Field bean F Sitona lineatus Convention BBCH 09 – 69 a) 2 a) 0.025 a) 0.015 200 / 400 7/14 PHI 7 days for fresh beans without pods Bruchus Rufimanus al hydraulic (14 days) PHI 14 days for dry beans spray application b) 0.030 b) 0.030 b) 2 (14 days) 8 UK, BE Linseed F Aphthona euphorbiae Convention BBCH 09 – 14 a) 2 a) 0.100 a) 0.010 200 / 400 120 al hydraulic (7 days) spray application b) 0.200 b) 0.020 b) 2

Applicant: FMC Chemical s.p.r.l. Evaluator: DE Date: August 2018 Part B – Section 1 Fury 100 EW Registration Report – Central Zoneo Core Assessment Page 15 of 15f Germany

(7 days) 9 CZ, HU, Grape F Eupoecilia ambiguella Broadcast BBCH 12 – 31 a) 2 a) 0.200 a) 0.020 200 / 500 14 SK Lobesia botrana air-assisted (14 days) spray application b) 0.400 b) 0.040 b) 2 (14 days) 10 CZ Mustard F Weevils: CEUTNA, Broadcast BBCH 19 -53 a) 2 a) 0.100 a) 0.010 200 / 400 60 CEUTQU air-assisted (14 days) Meligethes aeneus spray application b) 0.200 b) 0.020 b) 2 (14 days) 11 CZ Poppy F Aphididae Broadcast BBCH 18 – 71 a) 2 a) 0.100 a) 0.010 200 / 400 42 air-assisted (7 days) spray application b) 2 b) 0.200 b) 0.020 (7 days) 12 HU, SK Maize F Diabrotica sp. DIABVI, Broadcast BBCH 31 – 100 a) 1 a) 0.375 a) 0.0375 200 / 400 56 Ostrinia air-assisted (-) nubilalisPYRUNU spray application b) 0.375 b) 0.0375 Tanymecus dilaticollis b) 1 (-)

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (i) g/kg or g/l situation should be described (e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds application (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions of use (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 must be provided (f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

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REGISTRATION REPORT Part B

Section 5 Environmental Fate Detailed summary of the risk assessment

Product code: Fury 10 EW Active Substance: zeta-cypermethrin 100 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Cheminova Deutschland GmbH & Co. KG Date: November 2016

FMC Chemical sprl Evaluator: Germany November 2016 Part B – Section 5 Fury 10 EW Registration Report Core Assessment Central Zone

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Table of Contents TABLE OF CONTENTS ...... 2 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ...... 3

5.1 GENERAL INFORMATION ON THE FORMULATION ...... 3 5.2 PROPOSED USE PATTERN ...... 3 5.3 INFORMATION ON THE ACTIVE SUBSTANCES ...... 4 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ...... 5 5.4.1 Rate of degradation in soil...... 5 5.4.2 Adsorption/desorption ...... 5 5.4.3 Rate of degradation in water and sediment ...... 5

5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (PECSOIL) (KIIIA1 9.4) ...... 6 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (PECSW/PECSED) (KIIIA1 9.7) 7 5.7 RISK ASSESSMENT GROUND WATER (KIIIA1 9.6) ...... 7 5.8 POTENTIAL OF ACTIVE SUBSTANCE FOR AERIAL TRANSPORT ...... 7 APPENDIX 1 TABLE OF INTENDED USES JUSTIFICATION AND GAP TABLES ...... 9

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FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) The exposure assessment of the plant protection product Fury 10 EW has already been evaluated in the core assessment of the main application by Poland, part B, section 5, dated March 2014 and the respective National Addendum Germany, part B, section 5, dated November 2016. For this supplemental application, dated 02.01.2014 and targeted for Germany only, no full core assessment was conducted as the use applied for is bascially covered by the core assessment by Poland. Concerning the fate and behaviour in the environment, no dossier or additional studies were submitted by the applicant or considered by the evaluator (Germany). Therefore the risk and exposure assessment of the intended use of Fury 10 EW in cereal according to use No. 001 (supplemental application) predominantly refers to the completed assessment of the main application and its uses 001-019 for Germany, outlined in the core assessment by Poland and the national addendum Germany. This core assessment comprises an exposure assessment for authorization of the plant protection product Fury 10 EW in Germany according to its supplemental use in cereal (see also Appendix 3) restricted to the respective points where additional information is required, calculations are adjusted or the assessment deviates from the core assessment of the main application conducted by Poland. The national addendum Germany is included containing country specific assessments for some annex points.

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation Fury 10 EW

Code WL 43467 / FMC-56701-I-0-EW Plant protection product Fury 10 EW Applicant FMC Chemical sprl Date of application 05.06.2012 (main application) / 02.01.2014 (supplemental application) Formulation type EW Active substance (as) zeta-cypermethrin Concentration of as (g/L) 100

5.2 Proposed use pattern

The GAP used for exposure assessment is presented in Table 5.2-1. There is only one intended use. It is given in detail in Appendix 1. Table 5.2-1: Critical use pattern of Fury 10 EW

Group Crop/growth Application Number of applications, Application rate, Soil effective stage method / Minimum application cumulative application rate Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season)

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- Wheat Spraying / 2 x, 7 d, spring / summer zeta-cypermethrin zeta- (TRZSS), Oats arable crops 1. 25 % 2 x 15 = 30 cypermethrin (AVESS), 2. 25 % 1. 11,25 Barley 2. 11,25 (HORVX) / = 22,5 BBCH 12-51

5.3 Information on the active substances

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

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5.4 Summary on input parameters for environmental exposure assessment

5.4.1 Rate of degradation in soil Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

5.4.2 Adsorption/desorption Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

5.4.3 Rate of degradation in water and sediment Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

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5.5 Estimation of concentrations in soil (PECsoil) (KIIIA1 9.4)

PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation kinetics. A soil bulk density of 1.5 g/cm3, a soil depth of 5 cm and a tillage depth of 20 cm (arable crop) were assumed. The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented in tables below.

Table 5.5-1: Application related input parameters for PECSoil calculations

Plant protection product Fury 10 EW Use No.: 001

Crop: cereal Application rate: 2 x 15 g/ha Number of applications/interval: 2, 7d Crop interception: 25 %

Table 5.5-2: Substance related input parameters for PECsoil calculation

Active substance DT50 value in accordance to EU endpoint zeta-cypermethrin 24.24 d (SFO, Maximum, Field yes studies, EU endpoint)

Due to the fast degradation of the active substance zeta-cypermethrin in soil (DT90 < 365 d, SFO, field data) the accumulation potential of zeta-cypermethrin does not need to be considered.

Therefore an accumulated soil concentration (PECaccu) is used for risk assessment that comprises background concentration in soil (PECbkgd) considering a tillage depth of 20 cm (arable crop) and the maximum annual soil concentration PECact for a soil depth of 5 cm.

Besides PECact values also PECtwa, 21 d values are required for risk assessment. PECtwa,21 d values are also presented in Table 5.5-3.

Table 5.5-3: Results of PECsoil calculation for application of Fury 10 EW in cereal (soil bulk density 1.5 g/cm-3, soil depth 5 cm) according to use No. 001

active substance/ soil relevant PECact PECtwa 21 tillage PECbkgd PECaccu = preparation application rate (mg/kg) d depth (cm) (mg/kg) PECact + (g/ha) (mg/kg) PECbkgd (mg/kg) Fury 10 EW 2 x 112.5 0.273 - - - - zeta-cypermethrin 2 x 11.25 0.0273 0.0207 20 < 0.0001 0.0273

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5.6 Estimation of concentrations in surface water and sediment (PECsw/PECsed) (KIIIA1 9.7)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

5.7 Risk assessment ground water (KIIIA1 9.6)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

5.8 Potential of active substance for aerial transport

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section.

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Table of Intended Uses justification and GAP tables GAP rev. (No), date: 2016-08-17

PPP (product name/code) FURY 10 EW Formulation type: EW active substance zeta-Cypermethrin Conc. of as : 100g/l

Applicant: FMC Chemical sprl professional use Zone(s): Germany non professional use

Verified by MS: Yes

1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number kg, L product / g, kg as/ha Water L/ha e.g. safener/synergist per ha (crop destination / I (additionally: Kind stage of crop & (min. interval ha purpose of crop) developmental stages of season between a) max. rate per a) max. rate min / max e.g. recommended or the pest or pest group) applications) appl. per appl. mandatory tank mixtures a) per use b) max. total rate b) max. total b) per crop/ per crop/season rate per season crop/season 001 DE Wheat (TRZSS), Oats F Aphids as virus vectors Spraying BBCH 12-51 a) 2 (treatments a) 0.15 l/ha a) 15 g as/ha 200-400 28 (AVESS), Barley must be at least b) 0.3 l/ha b) 30 g as/ha l/ha (HORVX) 7 days apart) b) 2 (treatments must be at least 7 days apart)

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Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (8) The maximum number of applications possible under practical conditions of use for each single (2) Member State(s) or zone for which use is applied for application and per year (permanent crops) or crop (annual crops) must be provided (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) Min. interval between applications (days) were relevant situation should be described (e.g. fumigation of a structure) (10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) must be given in metric units (e.g. kg or L product / ha) (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (12) The range (min/max) of water volume under practical conditions of use must be given (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, (L/ha) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (13) PHI - minimum pre-harvest interval application (14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.

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REGISTRATION REPORT Part B

Section 5 Environmental Fate Detailed summary of the risk assessment

Product code: Fury 10 EW Active Substance: zeta-cypermethrin 100 g/L

Central Zone Zonal Rapporteur Member State: Poland

NATIONAL ADDENDUM – Germany

Applicant: Cheminova Deutschland GmbH & Co. KG Date: November 2016

FMC Chemical sprl Evaluator: Germany (UBA) November 2016

Part B – Section 5 Fury 10 EW Registration Report National Addendum– Germany Central Zone zRMS: Poland

Page 2 of 14

Table of Contents TABLE OF CONTENTS ...... 2 SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ...... 3

5.1 GENERAL INFORMATION ON THE FORMULATION ...... 3 5.2 PROPOSED USE PATTERN ...... 3 5.3 INFORMATION ON THE ACTIVE SUBSTANCES ...... 4 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ...... 4 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ...... 5 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) ...... 6 5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition ...... 6 5.6.2 PECSW after exposure by surface run-off and drainage ...... 7 5.7 RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6) ...... 8 5.7.1 Direct leaching into groundwater ...... 8 5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage ...... 10 APPENDIX 1 TABLE OF INTENDED USES IN GERMANY ...... 13

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Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) The exposure assessment of the plant protection product Fury 10 EW has already been evaluated in the core assessment of the main application by Poland, part B, section 5, dated March 2014 and the respective National Addendum Germany, part B, section 5, dated November 2016. This national addendum contains country specific assessments for some annex points and is restricted to the respective points where additional information is required or the assessment deviates from the core assessment by Poland or the national addendum Germany of the main application. For this supplemental application, dated 02.01.2014 and targeted for Germany only, no dossier or additional studies were submitted by the applicant or considered by the evaluator (Germany). Therefore the risk and exposure assessment of the intended use of Fury 10 EW in cereal according to use No. 001 (supplemental application) predominantly refers to the completed assessment of the main application and its uses 001-019 for Germany, outlined in the core assessment by Poland and the national addendum Germany. PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary (see National addendum Germany, part B, section 6 and part A).

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation Fury 10 EW

Code WL 43467 / FMC-56701-I-0-EW Plant protection product Fury 10 EW Applicant FMC Chemical Date of application 05.06.2012 (main application) / 02.01.2014 (supplemental application) Formulation type EW Active substances (as) zeta-cypermethrin Concentration of as (g/L) 100

5.2 Proposed use pattern

The GAP used for exposure assessment is presented in Table 5.2 1. There is only one intended use. It is given in detail in Appendix 1. The intended use in Germany is covered by the core assessment of the main application by Poland and partly by the respective National addendum Germany. Due to a slightly higher soil effective application rate, the calculations for estimations of concentrations in soil and surface water were adjusted accordingly.

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Table 5.2-1: Intended use in Germany for Fury 10 EW

Group Crop/growth Application Number of applications, Application rate, Soil effective stage method / Minimum application cumulative application rate Drift scenario interval, interception, (g as/ha) (g as/ha) application time (season) - Wheat Spraying / 2 x, 7 d, spring / summer zeta-cypermethrin zeta- (TRZSS), Oats Ackerbau 1. 25 % 2 x 15 = 30 cypermethrin (AVESS), (arable crops) 2. 25 % 1. 11,25 Barley 2. 11,25 (HORVX) / = 22,5 BBCH 12-51

5.3 Information on the active substances

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

5.4 Summary on input parameters for environmental exposure assessment

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 5 and the respective National addendum Germany, part B, section 5.

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5.5 Estimation of concentrations in soil (KIIIA1 9.4)

For input parameters and additional information please refer to the National addendum Germany, part B, section 5, for the main application

The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented in Table 5.5-1.

Table 5.5-1: Input parameters for Fury 10 EW for PECsoil calculation

Active substance DT50

zeta-cypermthrin 24.24 d (SFO, Maximum, Field studies, EU endpoint)

Table 5.5-2: Results of PECsoil calculation for the intended use in cereals used for German risk assessment

plant protection product: Fury 10 EW use: 01-001 Number of applications/intervall 2, 7d application rate: 2 x 15 g/ha crop interception: 25 %

active substance/ soil relevant soil depthact PECact tillage PECbkgd PECaccu = formulation application rate (cm) (mg/kg) depth (cm) (mg/kg) PECact + (g/ha) PECbkgd (mg/kg) Fury 10 EW 2 x 112.5 1 1.364 - - - zeta-cypermthrin 2 x 11.25 1 0.1364 20 < 0.0001 0.1364

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5.6 Estimation of concentrations in surface water and sediment (KIIIA1 9.7)

Results of PECsw calculation of zeta-cypermethrin in using FOCUS Surface Water are given in the core assessment of the main application by Poland. For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to allow risk mitigation measures separately for each entry route. Surface water exposure via spray drift and volatilization with subsequent deposition is estimated with the model EVA 3. Surface water exposure via surface run-off and drainage is estimated using the model EXPOSIT 3.0. The German surface water exposure assessment is outlined in the following chapters.

5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzelmeier. The vapour pressure at 20 °C of the active substance zeta-cypermethrin is < 10-5 Pa. Hence the active substance zeta-cypermethrin is regarded as non-volatile. Therefore exposure of surface water by the active substance zeta-cypermethrin due to volatilization with subsequent deposition does not need to be considered. The calculation of PECsw after exposure via spray drift and volatilization with subsequent deposition is performed using the model EVA 3. For a single application, the exposure assessment via spray drift is based on the application rate in conjunction with the 90th percentile of the drift values. For multiple applications, lower percentiles of the drift values for each application are applied, resulting in an overall 90th percentile of drift probabilities. Only one volatilization event following the last use of pesticide is generally considered. However, for the active substance zeta-cypermethrin the calculated peak PECsw for multiple applications in EVA are lower than for one single application. Thus, PECsw were calculated for a single application only. For the finalization of the aquatic risk assessment the endpoints (i.e. RAC values) for single and double applications differ and were therefore considered respectively (see National addendum Germany, part B, section 6, chapter 6.5). The endpoints used for modelling of surface water exposure via spray drift and volatilization with subsequent deposition with EVA 3 are summarized below.

Table 5.6-1: Endpoints of zeta-cypermthrin used for the PECSW calculations with EVA 3 Parameter zeta-cypermethrin Reference Vapour pressure at … °C (Pa) not required since no v/d Solubility in water at … °C (mg/L) not required since no v/d

DissT50 water (d) 0.1 d EU endpoint

The calculated PECsw values after exposure via spray drift for zeta-cypermethrin for the intended use of Fury 10 EW are presented in the National addendum Germany, part B, section 6, chapter 6.5 considering the following input parameters related to the application.

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Table 5.6-2: Input parameters for Fury 10 EW used for PECSW calculations with EVA 3

Use No.: 01-001 Number of applications/ interval: 2, 7 d* Application rate zeta-cypermethrin: (g a.s./ha) 2 x 15 * Calculated peak PECsw for multiple applications is lower than for single application. Thus, only single application is considered.

5.6.2 PECSW after exposure by surface run-off and drainage The concentration of the active substance zeta-cypermethrin in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3.01. The substance specific input parameters used for modelling surface water exposure via run-off and drainage into an adjacent ditch with EXPOSIT 3.01 are summarized in chapter 5.7.2 of this document.

Whether the K Foc value according to Input Decision or the EU-endpoint is used as input parameter for EXPOSIT, doesn’t influence PEC results. Both adsorption values are of a very high range and therefore indicate immobility of the active substance.

The calculated PECSW in an adjacent ditch due to surface run-off and drainage for the active substance zeta-cypermethrin for the intended uses of Fury 10 EW in are presented in the National addendum Germany, part B, section 6, chapter 6.5 considering the following input parameters related to the application.

Table 5.6-3: Input parameters related to the application for PECsw calculations with Exposit 3.01

Use No.: 01-001 Number of applications/ interval: 2, 7 d Application rate zeta-cypermethrin: (g a.s./ha) 2 x 15 Crop interception: 25 %

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5.7 Risk assessment for groundwater (KIIIA1 9.6)

Results of the PECgw calculation of zeta-cypermethrin for the intended uses of Fury 10 EW according to EU assessment using FOCUS PEARL are given in the core assessment of the main application. For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and drainage of the active substance into an adjacent ditch with subsequent bank filtration into the groundwater. Direct leaching after soil passage is assessed following the recommendations of the publication of Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011) for tier 1 and tier 2 risk assessment. According to Hold et al, 2011, endpoints for groundwater modelling are derived with the program INPUT DECISION and subsequent simulations are performed for the groundwater scenario “Hamburg” of FOCUS PELMO. In tier 3 risk assessment, results of experimental studies (lysimeter studies and/or field leaching studies) can also be considered in German groundwater risk assessment. Surface run-off and drainage into an adjacent ditch with subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3. The German risk assessment for groundwater is given in the following chapters.

5.7.1 Direct leaching into groundwater

Table 5.7-1: Input parameters related to application for PECGW modelling with FOCUS PELMO 5.5.3

Uses evaluated 01-001 Application rate (g as/ha) zeta-cypermethrin: 2 x 0.015 Crop (crop rotation) cereal Date(s) of application(s) 01. April & 8. April Interception (%) 25 % Soil moisture 100 % FC Q10-factor 2.58 Moisture exponent 0.7 Plant uptake 0 Simulation period (years) 26

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Zeta-cypermethrin The endpoints used for groundwater modelling for zeta-cypermethrin and its metabolites DCVA and mBPA according to INPUT DECISION 3.3 are in Table 5.7-2.

Table 5.7-2: Input parameters related to zeta-cypermethrin for PECGW modelling

Parent zeta-cypermethrin Remarks/Reference to core assessment, part B, section 5 Molecular weight (g/mol) 416.31 Core Assessment point 9.6 DT50 in soil (d) 15.1

KFoc 83826 Input Decision (arithmetic mean all soils for FOCUS Hamburg szenario horizon 1-3 1/n 0.928 n= 7 (see point 5.4.2)) Metabolite DCVA Molecular weight (g/mol) 209.07 Core Assessment point 9.6 Formation fraction 0.26

DT50 in soil (d) 5.8 EU-agreed enpoint after confirmatory data

KFoc 28.3 submission 1/n 0.64 Metabolite mBPA Molecular weight (g/mol) 214.22 Core Assessment point 9.6 Formation fraction 0.15

DT50 in soil (d) 4.2 EU-agreed enpoint after confirmatory data

KFoc 151.7 submission 1/n 0.66

Table 5.7-3: PECGW at 1 m soil depth of zeta-cypermethrin and its metabolites DCVA & mBPA for German exposure assessment

th -1 80 Percentile PECGW at 1 m soil depth (µg L ) modeled by FOCUS PELMO 5.5.3 Use No. Scenario zeta-cypermethrin Metabolite DCVA Metabolite mBPA

01-001 Hamburg < 0.001 < 0.001 < 0.001

According to the results of the groundwater simulation with FOCUS-PELMO, a groundwater contamination of the active substance zeta-cypermethrin and the metabolites DCVA & mBPA in concentrations ≥ 0.1 µg/L is not expected for the intended use of Fury 10 EW in cereal.

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5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage

Zeta-cypermethrin The input parameters for zeta-cypermethrin used for modelling surface water exposure via run-off and drainage in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.0 are summarized in Table 5.7-4.

Table 5.7-4: Input parameters for zeta-cypermethrin used for PECGW calculations with EXPOSIT 3.01 Parameter Zeta-cypermethrin Reference

K Foc, Runoff 83826* arithmetic mean all soils for FOCUS Hamburg szenario horizon 1-3 n= 7 (see point 5.4.2)

KFoc, mobility class 83826* arithmetic mean all soils for FOCUS Hamburg szenario horizon 1-3 n= 7 (see point 5.4.2)

DT50 soil (d) 24.24 LoEP (see point 5.4.1) Solubility in water (mg/L) 0.0387 LoEP Mobility class I Reduction by bank filtration 100 % * Whether the K Foc value according to Input Decision (see also point 5.4.2) or the EU-endpoint is used as input parameter for EXPOSIT, doesn’t influence PEC results. Both adsorption values are in very high range and therefore indicate immobility of the active substance. As the reduction by bank filtration is assumed to be 100 % for zeta-Cypermethrin, no calculation is necessary. According to modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance zeta-cypermethrin due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

Metabolites of zeta-cypermethrin The soil metabolites of zeta-cypermethrin (see table 5.3-1) are formed >10 % in soil. Therefore potential ground water contamination due to bank filtration via surface water exposure by run-off and drainage needs to be assessed using EXPOSIT 3.01. The input parameter for the model EXPOSIT 3.01 are taken from the EU assessment and summarized in Table 5.7-5. Table 5.7-5: Input parameter for soil metabolites of zeta-cypermethrin for EXPOSIT 3.01 Parameter Metabolite DCVA Metabolite mBPA Reference Molecular weight (g/mol) 209.07 214.22 LoEP Correction factor 0.50 0.51 LoEP (416.31 g/mol for molecular weight a.s.) Maximum occurrence in 25.7 % 15 % Moser 2009, Addendum soil (%) to the DAR

K Foc, Runoff 28.3 151.7 LoEP

DT50 soil (d) 26.8 7 Addendum to the DAR Solubility in water (mg/L) 0.0387 0.0387 Same as for a.s. Mobility class 4 4

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Reduction by bank 100 % 100 % filtration

As the reduction by bank filtration is assumed to be 100 % for the soil metabolites DCVA & mBPA no calculation is necessary. According to modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1 µg/L by the soil metabolites of zeta-cypermethrin due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

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Appendix 1 Table of Intended Uses in Germany GAP rev. (No), date: 2016-08 -17

PPP (product name/code) FURY 10 EW Formulation type: EW active substance zeta-Cypermethrin Conc. of as : 100g/l

Applicant: FMC Chemical sprl professional use Zone(s): Germany non professional use

Verified by MS: Yes

1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number kg, L product / g, kg as/ha Water L/ha e.g. safener/synergist per ha (crop destination / I (additionally: Kind stage of crop & (min. interval ha purpose of crop) developmental stages of season between a) max. rate per a) max. rate min / max e.g. recommended or the pest or pest group) applications) appl. per appl. mandatory tank mixtures a) per use b) max. total rate b) max. total b) per crop/ per crop/season rate per season crop/season 001 DE Wheat (TRZSS), Oats F Aphids as virus vectors Spraying BBCH 12-51 a) 2 (treatments a) 0.15 l/ha a) 15 g as/ha 200-400 28 (AVESS), Barley must be at least b) 0.3 l/ha b) 30 g as/ha l/ha (HORVX) 7 days apart) b) 2 (treatments must be at least 7 days apart)

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Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (8) The maximum number of applications possible under practical conditions of use for each single (2) Member State(s) or zone for which use is applied for application and per year (permanent crops) or crop (annual crops) must be provided (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) Min. interval between applications (days) were relevant situation should be described (e.g. fumigation of a structure) (10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) must be given in metric units (e.g. kg or L product / ha) (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (12) The range (min/max) of water volume under practical conditions of use must be given (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, (L/ha) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of (13) PHI - minimum pre-harvest interval application (14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.

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REGISTRATION REPORT Part B

Section 6: Ecotoxicological studies Detailed summary of the risk assessment

Product code: Fury 10 EW Active Substance: Zeta-Cypermethrin 100 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Cheminova Deutschland GmbH & Co. KG

Date: November/2016

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Table of Contents SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)...... 3 6.1 GAP AND OVERALL CONCLUSIONS ...... 4 6.1.1 Table of intended uses ...... 4 6.1.2 Grouping of intended uses for risk assessment ...... 5 6.1.3 Consideration of metabolites ...... 5 6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ...... 5 6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC 10.1.2) ...... 5 6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC 10.1.3) ...... 5 6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ...... 5 6.5.1 Justification for new endpoints ...... 5 6.5.2 Overall conclusions ...... 6 6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) ...... 6 6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ...... 6 6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1, KPC 10.4.2) ...... 6 6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) ...... 7 6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) ...... 7 6.11 EFFECTS ON OTHER TERRESTRIAL ORGANISMS (FLORA AND FAUNA) (KPC 10.7) ...... 8 6.12 MONITORING DATA (KPC 10.8) ...... 8 6.13 AVAILABLE PRELIMINARY DATA (IIIA 10.9) ...... 8 6.14 OTHER/SPECIAL STUDIES (IIIA 10.10) ...... 8

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Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10) The exposure assessment of the plant protection product Fury 10 EW has already been evaluated in the core assessment of the main application by Poland, part B, section 6, dated March 2014 and the respective National Addendum Germany, part B, section 6, dated November 2016. For this supplemental application, dated 02.01.2014 and targeted for Germany only, no full core assessment was conducted as the use applied for is bascially covered by the core assessment by Poland. Concerning the fate and behaviour in the environment, and the ecotoxicology and risk assessment, no dossier or additional studies were submitted by the applicant or considered by the evaluator (Germany). Therefore the risk and exposure assessment of the intended use of Fury 10 EW in cereal according to use No. 001 (supplemental application) predominantly refers to the completed assessment of the main application and its uses 001-019 for Germany, comprised in the core assessment by Poland and the national addendum Germany. This core assessment only contains a limited exposure assessment of surface water and soil for authorization of the plant protection product Fury 10 EW in Germany according to its supplemental use in cereal (see also Appendix 3) for the respective points where additional information is required or the assessment deviates from the core assessment of the main application conducted by Poland. PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary (see National addendum Germany, part B, section 6 and part A).

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6.1 GAP and overall conclusions

The GAP used for exposure assessment is presented in Table 6.1.1 – there is only one intended use. The intended uses in Germany is covered by the core assessment performed by Poland.

6.1.1 Table of intended uses Table 6.1-1: GAP and overall conclusions

Application per Overall conclusions Max treatment number Intended Timing F/G appl. kg Rate/season Non- use (BBCH) Aquatic Wild Non-target Soil (interval a.s./ha [kg a.s./ha] Birds Mammals target organisms Pollinators arthropods organisms in days) max max plants

Wheat (TRZSS), Oats F 12-51 2 (7 d) 0.015 0.030 (AVESS), Barley (HORVX) F: Field use; G: Glasshouse use

Safe use identified

Remarks: Further refinement and/or risk mitigation measures are needed

No safe use identified and considered possible

Explanations: The colours in the Table 6-1 are intended to reflect the outcome of the assessments including the available and valid refinement steps and risk mitigations measures.

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6.1.2 Grouping of intended uses for risk assessment No grouping was conducted, because only one intendend use was submitted and assessed within this registration process (see 6.1.1).

6.1.3 Consideration of metabolites Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1, KPC 10.1.2)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC 10.1.3)

Not available and not yet considered in the regulation process.

6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.5.1 Justification for new endpoints Different endpoint had been derived in the National addendum Germany, part B, section 6 belonging to the core assessment of the main application by Poland dated March 2014, part B, section 6. There you will find explanations for the deviations related to the acute fish SSD (HC5 = 0.5067 µg a.s./L), the NOEC fish (NOEC = 0.015 µg a.s./L) and the overall RAC for single (4 ng as/L) and double applications (of 1.3 ng as/L). The latter RACs clelaly differed from the acceptable concentration (EAC) of 0.008 µg a.s./L by zRMS Poland. Also differing is the RAC Algae (ErC50 = 5.33 µg a.s./L).

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6.5.2 Overall conclusions Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC 10.4.1, KPC 10.4.2)

Regarding the risk towards earthworms, please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6. For the evaluation of the active substance at EU-level, the study of Goßmann & Leopold (2011) was submitted as confirmatory data in 2012 and discussed in a peer review by the member states (reporting table zeta-cypermethrin, 17.08.2012). The main discussion points obtained the comparability of the intended use in maize towards other cultures as well as the conducted seedtreatment of maize with methiocarb. Based on the risk assessment for soil organisms for the active substance methiocarb on EU-level, no concern was stated for soil organisms elicted by this seed treatment. As maize intended the highest application rate compared to other indications, the conducted study set up was classified as suitable for other indications than maize. In a conclusion, the study was accepted at EU-level. In the core assessment of the main application by Poland dated March 2014, the field study on non target arthropods (Goßmann & Leopold 2011) including soil organisms was used by the zRMS for the risk assessment. For zonal relegislation of the product Fury 10 EW, germany reevaluated the study once again and found a few shortcomings, summarized below: For the conduction of field studies on collembolans or mites, no guideline is available at the moment. Therfore, the ISO 11268-3:1999 as well as the complementary recommendations of KULA (2006)1 describing the conduction of field effects on earthworms are used as guidance regarding the set up as well as evaluation of field studies for collembolans and mites. In order to detect long lasting effects on soil organisms in a field situation, the duration of the study was too short as effects on collembolans were

1 Kula C., Heimbach F., Riepert F., Römbke J. (2006): Technical recommendations for the update oft he ISO earthworm field test guideline (ISO 11268-3)

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observed only for 30 days after application of the test substance. Based on the actual guideline for field tests on earthworms (ISO 11268-3:1999), field tests for soil organisms other than earthworms should last for 12 month. Moreover, the effect of the reference substance should reduce the population by 40 – 80 %, but the reference substance in Goßmann & Leopold (2011) did not show any effects. The comparability of the control plot versus the treated plots was not given as the number of Collembolans did diver strongly between the control and the field rate (37.5 g a.s./ha). Therefore, effects might be hidden as the detection of effects in the treatments is refered towards the control. The evaluation of effects was carried out on the level of groups but not on species level, therefore, effects on single species might be hidden by this kind of evaluation but are classified as ecological relevant endpoint. The principle response curve did not show any significant effect; in a conclusion, the study is not able to detect any effects on collembolans. In terms of absolute individual numbers, the study shows some effects: Collembolae have been caught using soil core sampling or pitfall traps. After the treatment with three different concentrations of Zeta- Cypermethrin (37.5 g a.s./ha, 1.04 g a.s./ha and 0.21 g a.s./ha) a considerable change in species composition was identified. In the highest test dose, the most abundant group of Poduromorpha dissappeared almost completely, comparing the first and the second sampling date (abundances of 5000 or rather 1000 individuals were lowered to about 10). As well at 37.5 g ai/ha, the group of Symphleona increased temporarely, followed by a population decline. The population of Entomobryomorpha seemed to be not affected by all treatment rates but increased clearly in the highest treatment rate after application of the test substance, probably due to the changed competitive situation. Consequently the endpoint of 37.5 kg a.s./ha derived from this new field study is questioned by germany.

Due to conformity to the decision at EU level, the EU agreed endpoint can be used for the risk assessment. But based on the shortcomings mentioned above, germany will claim a legislation accompanying field study with collembolans, lasting one year (Please refere to the NA). For national legislation procedures, member states are asked to include risk mititagion measures or claim additional information like a field study.

6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

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6.11 Effects on other terrestrial organisms (flora and fauna) (KPC 10.7)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.12 Monitoring data (KPC 10.8)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.13 Available preliminary data (IIIA 10.9)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

6.14 Other/special studies (IIIA 10.10)

Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

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REGISTRATION REPORT Part B

Section 6: Ecotoxicological studies Detailed summary of the risk assessment

Product code: Fury 10 EW Active Substance: Zeta-Cypermethrin 100 g/L

Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ADDENDUM

Applicant: Cheminova Deutschland GmbH & Co. KG

Date: November/20186

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Table of Contents SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)...... 3 6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES ...... 4 6.1.1 Intended uses for risk assessment ...... 4 6.1.2 Consideration of metabolites ...... 4 6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ...... 5 6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC 10.1.2) ...... 5 6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC 10.1.3) ...... 5 6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ...... 5 6.5.1 Overview ...... 5 6.5.2 Toxicity ...... 5 6.5.3 Justification for new endpoints ...... 5 6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ...... 6 6.5.5 Overall conclusions ...... 8 6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) ...... 8 6.6.1 Effects on wild pollinators ...... 8 6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ...... 10 6.7.1 Toxicity ...... 10 6.7.2 Justification for new endpoints ...... 10 6.7.3 Risk assessment ...... 10 6.7.4 Conclusion...... 13 6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1, KPC 10.4.2) ...... 14 6.8.1 Justification for new endpoints ...... 14 6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna, TERA and TERLT (MIIIA 10.6.1) ...... 14 6.8.3 Higher tier risk assessment ...... 15 6.8.4 Overall conclusions ...... 15 6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) ...... 16 6.9.1 Justification for new endpoints ...... 16 6.9.2 Risk assessment ...... 16 6.9.3 Overall conclusions ...... 16 6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) ...... 17 6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ...... 17 APPENDIX 1 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 17.08.2016) 18

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Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10) As a full risk assessment according to Uniform Principles for the plant protection product Fury 10 EW in its intended uses in cereals, oilseed rape and peas is documented in detail in the core assessment of the plant protection product Fury 10 EW dated from 03.03.2014, corrected on 27.03.2015, performed by zRMS Po- land, no new core assessment has been conducted by Germany. Please refer to the core assessment of the main application by Poland dated March 2014, part B, section 6 and the respective National addendum Germany, part B, section 6.

This document comprises specific risk assessment for some annex points for authorization of the plant protection product Fury 10 EW in Germany according to the uses listed in Appendix 2. General information on the formulation Fury 10 EW can be found in Table 5.1-1 of Section 5 of the National addendum Germany.

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6.1 Proposed use pattern and considered metabolites

6.1.1 Intended uses for risk assessment Full details of the proposed use pattern of the formulation Fury 10 EW that will be assessed are presented in Appendix 1 and summarized in the table below.

Table 6.1-1: Critical use pattern of Fury 10 EW

use No. Crop/growth Application method/drift Application rate, Soil effective stage/interception scenario/ Number of cumulative (g application rate applications, Minimum a.s./ha) (g as/ha) application interval/ application time 00-001 Wheat (TRZSS), Oats Spraying/“arable crops“/2x, 7 Zeta-Cypermethrin: Zeta-Cypermethrin (AVESS), Barley (HORVX) / days/spring-summer 1. 15 1. 11.25 BBCH 12-51 / 2. 30 2. 11.25 INTERCEPTION: 25% = 22.5

6.1.2 Consideration of metabolites Please refer to the core assessment.

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6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)

The intended use of Fury 10 EW in cereals is covered by the intended uses discussed in the Polish core assessment.

Consequences for authorization: None.

6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1, KPC 10.1.2)

The intended use of Fury 10 EW in cereals is covered by the intended uses discussed in the Polish core assessment.

Consequences for authorization: None.

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC 10.1.3)

Please refer to the core assessment.

Consequences for authorization: None

6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)

6.5.1 Overview For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to allow risk mitigation measures separately for each entry route. The risk assessment for aquatic organism for authorization of Fury 10 EW is outlined in the following chapters.

6.5.2 Toxicity Please refer to the core assessment and German National Addendum.

6.5.3 Justification for new endpoints Please refer to the core assessment and German National Addendum.

The relevant endpoint for an aquatic risk assessments is: RACaquatic invertebrate community = 1.3 ng a.s./L (double applications, mesocosm test).

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6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with the recommendations of the “Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters” (EFSA Journal 2013;11(7):3290).

6.5.4.1 TER values for the entry into surface water via spraydrift and deposition following volatilization The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzel- meier. Zeta-Cypermethrin has a vapour pressure of < 10-5 Pa and is therefore classified as non-volatile. Hence, deposition following volatilization has not been considered. The input parameters for Zeta-Cyper- methrin are given in Section 5.6. Several ecotoxicological endpoints are available to assess the risk of the active substance Zeta-Cyperme- thrin and the formulation Fury 10 EW (see chapter 6.5.2). The RAC of an aquatic invertebrate community is derived from a higher tier study and is therefore the relevant scenario for risk assessment. Table 6.5-1: Risk assessment for zeta-Cypermethrin for aquatic organisms for the entry route via spraydrift and deposition following volatilization under the implementation of dif- ferent risk mitigation measures

Compound: Zeta-Cypermethrin Crop/Application rate: Cereals, spraying Growth stage and season BBCH 12-51 Intended use: 00-001

DT50 water (SFO): 0.1 (EU LoEP) PEC-selection: actual Drift-Percentile: 90%1 Buffer Entry via Entry via PECsw; conventional and drift reducing technique zone spraydrift deposition following volatilization 0% conv. 50% red. 75% red. 90% red. [m] [%] [µg/ha] [%] [µg/L] [µg /L] 1 2.77 0.139 -/- -/- 0.139 0.069 0.035 0.014 5 0.57 0.029 -/- -/- 0.029 0.014 0.007 0.003 10 0.29 0.015 -/- -/- 0.015 0.007 0.004 0.001 15 0.20 0.010 -/- -/- 0.010 0.005 0.003 0.001 20 0.15 0.008 -/- -/- 0.008 0.004 0.002 0.001 Relevant toxicity endpoint: RACaquatic invertebrate community = 1.3 ng a.i./L Relevant TER: 1 Buffer zone [m] TER 1 0.0 0.0 0.0 0.1 5 0.0 0.1 0.2 0.5 10 0.1 0.2 0.4 0.9 15 0.1 0.3 0.5 1.3 20 0.2 0.3 0.7 1.7 Risk mitigation measures NW 607 (15 m, 90 %) PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.

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1: For the active substance calculated PECpeak,sw for multiple applications are lower than for one single application. Thus, PECsw were calculated for single applications only (see section 5.6.2).

6.5.4.2 TER values for the entry into surface water via run-off and drainage The concentration of the active substance Zeta-Cypermethrin in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3.01. The input parameters for Zeta-Cypermethrin for exposure modelling with EXPOSIT 3.01 are given in chapter 5.6.2.

Table 6.5-2: Risk assessment for zeta-Cypermethrin for aquatic organisms for the entry route via run-off and drainage under the implementation of different risk mitigation measures

Compound: Zeta-Cypermethrin

Application rate: 2 x 15 g a.i./ha

Intended use Cereals, spraying

Relevant toxicity endpoint: RACaquatic invertebrate community = 1.3 ng a.i./L

Relevant TER: 1

Run-off Buffer zone PEC TER [m] [µg/L] 0 0.00072 1.80 5 0.00063 2.08 10 0.00054 2.42 20 0.00038 3.46 Drainage Time of application PEC TER [µg/L] Autumn/winter/early spring 0.01 0.14 Spring/summer < 0.01 0.44

Risk mitigation measures No safe use on drained fields identified: NG 405.

PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.

6.5.4.3 Consideration of Metabolites Please refer to the core assessment.

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6.5.5 Overall conclusions Based on the calculated concentrations of zeta-Cypermethrin in surface water (EVA3rev2e1, EXPOSIT 3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to zeta-Cypermethrin according to the GAP of the formulation Fury 10 EW achieve the accept- ability criteria TER ≥ 1, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of Fury 10 EW in cereals according to the label.

Consequences for authorization: For the authorization of the plant protection product Fury 10 EW following labeling and conditions of use are mandatory:

Required Labelling

NW 264 Fury 10 EW: RACaquatic invertebrate community = 1.3 ng/L Conditions for use Fury 10 EW NW 468 use No. 00-001 NW 607 (15 m, 90 %) NG 405

6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1)

Please refer to the core assessment.

Consequences for authorization: None

6.6.1 Effects on wild pollinators For the risk assessment of wild pollinators the RMS considers as current scientific knowledge the EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees (EFSA Journal 2013; 11 (7):3295, 04. July 2014). Within the EFSA GD (EFSA Journal 2013) for wild pollinators there are different scenarios mentioned in the risk assessment, as there are: 1. Risk from foraging on the treated crop 2. Risk from foraging on an adjacent crop 3. Risk from foraging on weeds in the treated field 4. Risk from foraging in the field margin 5. Risk from foraging the following year on a permanent crop or on a succeeding crop for annual crops

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According to the table of intended uses (Appendix 1), all scenarios are relevant for the risk assessment. Usually worst case scenario for oral exposure is regarded for treated flowering crops. For reasons of effec- tiveness, only the worst case szenario has been regarded and is given in this risk assessement. EU endpoints were taken from the EFSA conclusion (EFSA, 2008).

Table 6.6-1: Acute contact toxicity screeening step in risk assessement for wild pollinators.

a.s. Species EU endpoint Application HQcontact= HQ trigger rate AR value LD50 acute AR/LD50contact [g a.s./ha] [µg a.s./bee]

Zeta-Cypermethrin solitary bee 0.002 (contact, 48h) 15 7500 > 8

For further details please refer to the core assessment. HQcontact values shown in bold exceed the relevant trigger.

Table 6.6-2: Acute oral toxicity screeening step in risk assessement for “wild” pollinators.

a.s. Species EU endpoint Applica- Shortcut ETRoral= Trigger toin Rate value SV LD50 acute AR * AR SV/LD50oral [µg a.s./bee] [g a.s./ha]

Zeta-Cypermethrin solitary 0.044 (oral, 48h) 15 5.7 1943 > 0.04 bee

For further details please refer to the core assessment. ETRoral values shown in bold exceed the relevant trigger.

Conclusion An unacceptable risk for solitary wild bees due to the exposure with residues of Zeta-Cypermethrin via spray drift and pollen/nectar exposition cannot be excluded according to the screening step. No higher tier evaluation has been conducted. Thus, the risk assessment could not be finalised.

Consequences for authorization: None.

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6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)

Please refer to the Polish core assessment and the respective German national addendum.

6.7.1 Toxicity Please refer to the core assessment.

Relevant endpoints for the risk assessment are listed in the table below.

Table 6.7-1: Available valid endpoints for Zeta-Cypermethrin

Species Test substance, Endpoint Source Used in risk substrate, duration assessment (scenario)

Extended laboratory tests

Aphidius Fury 10 EW, barley Mortality: EFSA Conclu- In-field, 1 sion, 2008 off-field rhopalosiphi seedlings, 48hrs + LR50 = 5.48 g a.s./ha 11 days (3D) Reproduction: < 50% effects @ 8.16 g a.s./haa

Typhlodromus Fury 10 EW, bean Mortality: EFSA Conclu- In-field,

pyri plants, 7 days (3D) LR50 = 0.085 g a.s./ha sion, 2008 off-field

Reproduction: < 50% effects @ 0.029 g a.s./ha

n.a. Two further species required on national level according to Schulte et al.1

n.a. Two further species required on national level according to Schulte et al.1

Community field study

Terrestrial ar- Fury 10 EW, maize NOAEC = 37.5 g a.s./ha Goßmann & In-field thropod commu- field (field study) Leopold, 2011 nity a Mistakenly stated as mL a.s./ha in EFSA-Conclusion (2008). See study of Bargen, H. (2001)

6.7.2 Justification for new endpoints Please refer to the core assessment.

6.7.3 Risk assessment The evaluation of the risk for non-target arthropods was performed in accordance with the recommenda- tions of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services

1 Schulte C, Füll, C and Kühlen, U, 1999. Bewertungskriterien des Umweltbundesamtes: Auswirkungen von Pflan- zenschutzmitteln auf terrestrische Arthropoden. Z. Umweltchem. Ökotox., 11(5): 261-266.

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(SANCO/10329/2002 rev.2 (final), October 17, 2002), and in consideration of the recommendations of the guidance document ESCORT 2.

Exposure Exposure of non-target arthropods living in non-target off-field areas to Fury 10 EW will mainly be due to spray drift from field applications. Off-field predicted environmental rates (PER-values) were calculated from in-field PERs in conjunction with drift values published by the BBA (20002) as shown in the following equation:   Maximumin − field PER x drift percentile   100 Off − field PER= vegetationdistribution factor(vdf ) where: vdf = vegetation distribution factor used in combination with test results derived from 2-dimen- sional exposure set-ups To account for interception and dilution by three-dimensional vegetation in off-crop areas, a vegetation distribution or dilution factor (vdf, see above) is incorporated into the equation when calculating off-field exposure in conjunction with toxicity endpoints derived from two-dimensional studies (e.g. glass plate or leaf discs). A vdf of 10 is recommended in the ESCORT 2 report when the off-field risk assessment is based on toxicity endpoints obtained in a test design with two-dimensional exposure but has been questioned. Germany considers a vdf of five as a more reliable value to extrapolate from a two dimensional exposure situation to the exposure situation in the field. The exposure estimation was based mainly on the ‘Retention Area Index’ (RAI) characterizing the total retention area of sprayed plant protection products in a canopy per base area. As a ‘realistic worst case scenario, meadow canopies < 20 cm height was chosen (Koch and Weisser, 20043; German Federal Environment Agency UBA, 20064). The derived vdf of 5 agrees well with field data by Koch et al. (2003)5, who compared measured residues of plant protection products on two dimensional surfaces with the measured residues on meadows next to a treated area (factor of 4.4 to 6.5 between median spray residues on leaves when a standard nozzle was used for spray application). For

2 BBA (Biologische Bundesanstalt für Land- und Forstwirtschaft) (2000): Abdrifteckwerte für Flächen- und Raumkulturen sowie für den gewerblichen Gemüse-, Zierpflanzen- und Beerenobstanbau. Bundesanzeiger 100, 26. Mai 2000, Köln, pp. 9879. 3 Koch H and Weisser P, 2004. Die Gesamtoberflaeche in Saumstrukturen als potentielle Retentionsflaeche fuer Driftpartikel, Retention Area Index (RAI). Nachrichtenblatt des Deutschen Pflanzenschutzdienstes, 56, 65-69.

4 German Federal Environment Agency (UBA), 2006. Exposure calculation for arthropods in field border structures - selection of an appropriate ‘vegetation distribution factor’. Parma.

5 Koch H, Weisser P and Landfried M, 2003. Effect of drift potential on drift exposure in terrestrial habitats. Nachrichtenblatt des Deutschen Pflanzenschutzdienstes, 55, 181-188.

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endpoints resulting from 3-dimensional studies, i.e. where spray treatment is applied onto whole plants, the vdf is not used.

Zeta-Cypermethrin has a vapour pressure of < 10-5 and is therefore classified as non-volatile. Hence, dep- osition following volatilization has not to be considered. The input parameters for Zeta-Cypermethrin are given in Section 5.6.1.

Regarding the results of the study with A. rhopalosiphi exposed to Fury 10 EW, the vegetation distribution factor does not have to be considered since it was conducted in 3D environment.

Risk assessment The assessment of the risk to non-target arthropods due to an exposure to Fury 10 EW was performed on basis of the calculation of toxicity-exposure ratios (TER values) according the following formula: L(E)R50(L product/ha) TER= Off − field PER(L product/ha)

The risk is considered acceptable if the values obtained are TER off-field > 10 when the ecotoxicological data resulted from Tier 1 tests on glass plates or TER off-field > 5 when the data were obtained in higher tier test (extended lab or field tests). A new higher-tier field study has been submitted and was reevaluated. The study clearly indicates a risk for Coccinellidae, even at the lowest rate tested. This result underlines the need for a conservative risk assessment. However, since additional data from the field study are available, a TER trigger of 5 for the off-field risk assessment has been used. The results of the risk assessment are summarized in the following tables. The results of the risk assessment are summarized in the following table. Table 6.7-2: Risk assessment for zeta-Cypermethrin for non-target arthropods for the entry route via spraydrift and deposition following volatilization under the implementa- tion of different risk mitigation measures

Compound: Zeta-Cypermethrin Intended use: 00-001 Drift-Percentile: 82%

Buffer Entry via Entry via PERoff-field; conventional and drift reducing technique zone spraydrift deposition following volatilization 0% conv. 50% red. 75% red. 90% red. [m] [%] [µg/ha] [%] [µg/ha] [µg/ha] 1 2.38 0.621 -/- -/- 0.621 0.311 0.155 0.062 5 0.47 0.123 -/- -/- 0.123 0.061 0.031 0.012 Relevant toxicity endpoint: LR50 = 0.085 g a.i./ha (Typhlodromus pyri) Relevant TER: 5 Buffer zone [m] TER 1 0.1 0.3 0.5 1.4 5 0.7 1.4 2.8 6.9 Risk mitigation measures NT 109 PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.

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6.7.4 Conclusion In the core assessment data from a laboratory study on T. pyrii were used to calculate a hazard quotient for zeta-Cypermethrin, resulting in high HQ-values and thus indicating a risk for in-field and off-field areas. In line with this, the following data gap is listed in the EFSA Conclusion (2008) and also listed as a critical area of concern: “The risk to non-target arthropods needs to be addressed further (e.g. field studies) includ- ing the risk to soil-dwelling non-target arthropods (relevant for all representative uses)”. A new higher-tier field study (Goßmann & Leopold, 2011) has been evaluated and already discussed during the peer review. Concernes have been adressed during the peer review by AT, concerning the appropiate- ness of this study for a refinement of an off-field risk assessment. Therefore the study was reevaluated. The conclusion of this reevaluation in presented below:

At taxon level, almost all taxa show effects of different intensity at the highest measured concentration (37.5 g a.s./ha). Further, Heteroptera show effects at lower concentrations (1.04 g a.s./ha) and Coccinellidae show effects even at the lowest concentration tested (0.21 g a.s./ha). Recovery took place only after several weeks or month, or, in case of Coccinellidae, not at all until the end of the study. At community level strong effects are shown as well. At the highest concentration mesaured of 37.5 g a.s./ha leaf-dwelling insects were affected with recovery after about 10 weeks. Ground-dwelling insects were affected, with recovery after 2 months. Arachnidea were affected, with recovery after 3 months. At the lower concentration of 1.04 g a.s./ha leaf-dwelling insects were affected with recovery after about 4 weeks. Ground-dwelling insects were affected, with recovery after about 1 months. Arachnidea were af- fected, with recovery after 10 days. Even at the lowest concentration of 0.21 g a.s./ha tested, ground-dwell- ing insects were affected. Recovery took place after about 2 months. In general recovery could not be taken in account to refine the risk for off-field populations. Consequently the endpoint of 37.5 kg a.s./ha derived from the new field study could not be used for the refinement of the off-field risk. A safe off-field risk is considered to be crucial to enable recovery of the in-field area. Further it is doubtfull whether an in-field community is representative for an off-field community of arthropods. Therefore, this field study is not useable for a refined off-field risk assessment. In addition, the test shows a high risk of zeta-Cypermethrin for insects and spiders. A complete first tier risk assessment is not possible, as studies with four sensitive indicator species are not available. However, as Tier2-studies with Aphidius rhopalosiphi and Typhlodromus pyri are available, a risk assessment has been conductet using the most sensitive endpoint for T. pyri.

Consequences for authorization: For the authorization of the plant protection product Fury 10 EW following labeling and conditions of use are mandatory:

Required Labelling

NN 3001 Fury 10 EW: Typhlodromus pyri ER50 = 0.085 g a.s./ha

NN 3002 Fury 10 EW: Typhlodromus pyri ER50 = 0.085 g a.s./ha

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Conditions for use Use No. 00-001 NT 109 (90%, 5 m)

6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC 10.4.1, KPC 10.4.2)

Please refer to the core assessment.

6.8.1 Justification for new endpoints Please refer to the core assessment.

6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna, TERA and TERLT (MIIIA 10.6.1) The evaluation of the risk for earthworms and other soil macro-organisms was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values for the active substances zeta-Cypermethrin and the major soil degradation products are presented in the table below. For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Ku- biak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirk- stoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ

360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As soil bulk density 1.5 g cm-3is assumed. The acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure to Fury 10 EW/zeta-Cypermethrin as well as the major soil degradation products of zeta-Cypermethrin was assessed by comparing the maximum PECSOIL with the 14-day LC50 value to generate acute TER values.

The TERA was calculated as follows:

LC50 (mg/kg) TER A = PECsoil (mg/kg) The chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breack- down resulting from an exposure to Fury 10 EW/zeta-Cypermethrin as well as the major soil degradation products of zeta-Cypermethrin was assessed by comparing the maximum PECSOIL with the NOEC value to generate chronic TER values. The TERLT was calculated as follows: NOEC (mg/kg) TER = LT PEC (mg/kg) soil

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The results of the risk assessment are summarized in the following table.

Species Test item Time scale LC50 corr Max. PECSOIL TER [mg a.s./kg soil dw] [mg a.s./kg soil dw] Eisenia fetida Fury 10 EW Acute 37.51 0.1364 275

Eisenia fetida Product / Chronic Not trigered, since the DT90 in soil is <100 days and zeta- a.s. / Cypermethrin is applied less than 3 times per year. methabolites Folsomia The PRAPeR 48 meeting concluded that studies with Collembola and mites were not formally candida triggered (DT90 < 100 days). However, the meeting agrees that the in-field risk assessment should be covered by a new field study for non-target arthropods.

TER values shown in bold fall below the relevant trigger.

1: EU-agreed endpoint (EFSA Scientific Report (2008) 196, 1-119)

6.8.3 Higher tier risk assessment Pleasr refer to the core assessment and the german national addendum of the main application.

Table 6.8-1: TER values for Collembolae (higher Tier, see chapter 5.5)

Species Intended use Time scale Endpoint Soil relevant TER effective appl. Rate, cummulative (PEC) (see Tab. 6.1-2) [g a.s./ha] [g a.s./ha] [EP / PEC] Collembolae 00-001 Chronic NOEC = 37.5 2 x 11.24 = 22.48 1.7 community

TER values shown in bold fall below the relevant trigger.

6.8.4 Overall conclusions Based on the predicted concentrations of Zeta-Cypermethrin/Fury 10 EW in soils, the TER values describ- ing the acute risk for earthworms following exposure to Zeta-Cypermethrin/Fury 10 EW according to the GAP of the formulation Fury 10 EW achieve the acceptability criteria TER ≥ 10 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for earthworms due to the intended use of Fury 10 EW in cereals, rape and peas according to the label. The results of the field study indicate a high risk for other soil meso-organisms (Collembolae). The TER values describing the acute risk for Collembolae following exposure to Zeta-Cypermethrin/Fury 10 EW according to the GAP of the formulation Fury 10 EW does achieve the acceptability criteria TER ≥ 1 ac- cording to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.

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Consequences for authorization: Due to conformity to the decision at EU level an acceptable risk for Collembolae is concluded. However, based on the shortcomings of the study mentioned above, a legislation accompanying field study with col- lembolans, lasting one year is claimed. The study set up as well as the evaluation of the observed results should be performed in dependence on the available guideline for field tests on earthworms ISO 11268- 3:1999 as well as the complementary recommendations of KULA (2006)6 and in consultation with the federal agency of environment (section IV 1.3.)

6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)

Please refer to the core assessment.

6.9.1 Justification for new endpoints Please refer to the core assessment.

6.9.2 Risk assessment The evaluation of the risk for soil microorganisms was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

Please refer to chapter 5.5 for the predicted environmental concentrations in soil (PECSOIL) of Zeta-Cyper- methrin and Fury 10 EW. The results of the risk assessment are summarized in the following table.

Table 6.9-1: Risk assessment for effects on soil micro-organisms

Test substance, Test concentration PECSOIL Risk acceptable Test type (adverse effects < 25%) [mg a.s./kg] [mg a.s./kg] [yes/no] Fury 10 EW, 0.2 mg a.s./kg soil dw 0.1364 Yes N-transformation (59 days) Fury 10 EW, 0.2 mg a.s./kg soil dw 0.1364 Yes C-transformation (59 days)

6.9.3 Overall conclusions Based on the predicted concentrations of Fury 10 EW in soils, the risk to soil microbial processes following exposure to Fury 10 EW according to the GAP of the formulation Fury 10 EW is considered to be acceptable

6 Kula C., Heimbach F., Riepert F., Römbke J. (2006): Technical recommendations for the update oft he ISO earth- worm field test guideline (ISO 11268-3)

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according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific princi- ples, point 2.5.2.

Consequences for authorization: None

6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6)

6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) Several data on the effect of Fury 10 EW on non-target terrestrial plants are available (EFSA Scientific Report (2008) 196, 1-119). According to the insecticidal effect of the formulation these effect values are substantially higher than those effects determined for non-target arthropods, which are therefore relevant for the risk assessment for terrestrial biocoenosis. A quantitative risk assessment for non-target terrestrial plants is for that reason not conducted in this national addendum.

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Appendix 1 Table of Intended Uses in Germany (according to BVL 17.08.2016) PPP (product name/code) Fury 10 EW Formulation type: EW active substance 1 zeta-Cypermethrin Conc. of as 1: 100 g/L

Applicant: FMC Chemical s.p.r.l. Professional use Zone: Germany

1 2 3 4 5 6 7 8 10 11 12 13 14

Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number kg, L product / g, kg as/ha Water L/ha e.g. safener/synergist per ha Kind ha (crop destination / pur- I (additionally: developmen- stage of crop & sea- (min. interval son min / max pose of crop) tal stages of the pest or between appli- a) max. rate per a) max. rate e.g. recommended or mandatory tank pest group) cations) appl. per appl. mixtures a) per use b) max. total rate b) max. total b) per crop/ per crop/season rate per season crop/season

00- DE Wheat (TRZSS), Oats F Aphids as virus vectors Spraying BBCH 12-51 a) 2 (treatments a) 0.15 L/ha a) 15 g a.s./ha 200/400 28 001 (AVESS), Barley must be at least b) 0.30 L/ha b) 30 g a.s./ha (HORVX) 7 days apart) b) 2 (treatments must be at least 7 days apart)

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REGISTRATION REPORT Part B Section 7: Efficacy Data and Information Detailed Summary

Product Code: FURY 10 EW Reg. No.: ZV1 024222-00/01 Active Substance: 100 g/L zeta-cypermethrin

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: FMC Chemical, sprl Date: November 2013

Evaluator: Julius Kühn-Institut Date: 2018-08-27

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Table of Contents

IIIA1 6 Efficacy Data and Information on the Plant Protection Product ...... 3 General information ...... 3 Recent registration situation/history of the PPP ...... 3 Information on the active ingredients (Uptake and mode of action) ...... 3 Information on crops and pests ...... 3 Information on the intended uses ...... 4 IIIA1 6.1 Efficacy data...... 4 IIIA1 6.1.1 Preliminary range-finding tests ...... 5 IIIA1 6.1.2 Minimum effective dose tests ...... 5 IIIA1 6.1.3 Efficacy tests ...... 7 IIIA1 6.1.4 Effects on yield and quality ...... 11 IIIA1 6.1.4.1 Impact on the quality of plants and plant products ...... 11 IIIA1 6.1.4.2 Effects on the processing procedure ...... 11 IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products ...... 11 IIIA1 6.2 Adverse effects ...... 11 IIIA1 6.2.1 Phytotoxicity to host crop...... 11 IIIA1 6.2.2 Adverse effects on health of host animals ...... 11 IIIA1 6.2.3 Adverse effects on site of application ...... 11 IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) ...... 12 IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ...... 16 IIIA1 6.2.6 Impact on succeeding crops ...... 16 IIIA1 6.2.7 Impact on other plants including adjacent crops ...... 16 IIIA1 6.2.8 Possible development of resistance or cross-resistance ...... 17 IIIA1 6.3 Economics ...... 17 IIIA1 6.4 Benefits ...... 17 IIIA1 6.4.1 Survey of alternative pest control measures ...... 17 IIIA1 6.4.2 Compatibility with current management practices including IPM...... 17 IIIA1 6.4.3 Contribution to risk reduction ...... 17 IIIA1 6.5 Other/special studies ...... 17 IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ...... 17 IIIA1 6.7 List of test facilities including the corresponding certificates ...... 18 Appendix 1: List of data submitted in support of the evaluation ...... 20 Appendix 2: GAP table ...... 36

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IIIA1 6 Efficacy Data and Information on the Plant Protection Product

General information This document summarises information related to the efficacy of the plant protection product FURY 10 EW (emulsion, containing 100 g/l zeta-cypermethrin) against cereal aphids as virus vectors. The control of virus transmission by aphids is a label extension with a post-emergence application (rate of 0.15 l/ha) on cereals. The applicant states that the use is planned for barley, oats, rye, triticale and wheat as a professional use. The active substance zeta-cypermethrin, which was included into Annex I of Directive 91/414 under EU Directive 2009/37/EC. The SAN- CO report for zeta-cypermethrin (SANCO/142/08 final rev 1 – 09/07/2010) is considered to pro- vide the relevant review information or a reference to where such information can be found. The information and data presented by the applicant were submitted in the frame of label extension of FURY 10 EW in Germany, meaning that Germany is zRMS and there are no cMS.

Recent registration situation/history of the PPP FURY 10 EW is registered in several countries in Europe in the central and the southern regis- tration zone and in Poland in the northern registration zone in several crops. This includes uses in cereals against aphids in most countries. In Germany the product is registered in cereals against cereal aphids, wheat blossom midge and cereal leaf beetle. It is further registered in Germany against pests of oilseed rape and peas.

Information on the active ingredients (Uptake and mode of action) Zeta-cypermethrin is a pyrethroid. Pyrethroids possess a predominant residual effect. They are not systemic in plants and have a low vapour pressure and long term persistent action. A fea- ture of pyrethroids is the fast initial efficacy by many species of insects known as knock down effect. Comparable to other pyrethroids of the new generation, the effect of zeta-cypermethrin is dependent on temperature. Low temperatures lead to a high toxicity of the active substance zeta-cypermethrin. Mainly contact but also ingestion by feeding lead to effects. Pyrethroids as zeta-cypermethrin act stereo selectively on the fast-voltage dependent sodium channels in ex- citable nerve membranes in several parts of the insect nervous system. The major initial effect is to delay the closing of the sodium channel activation gate. This results in a pronounced pro- longation of the inward sodium current that leads to the nerve membrane depolarization, caus- ing a block of nerve impulses. This disruption of nerve transmission results in hyperexcitation, tremors and convulsions, followed by paralysis and the death of the affected insect. Different insect species with different feeding modes, biting and sucking, are targeted as the active ingredient zeta-cypermethrin acts by contact as well as by ingestion of treated plant parts. The main target pests in arable and horticultural crops are sucking and biting insects. The active has good action on beetles. Crop damages due to the active ingredient are usually not ex- pected. Resistance to pyrethroids (all in IRAC Mode of Action Group 3A), combined with cross re- sistance between different pyrethroids, has been observed for several different pest insects al- ready. In Europe resistance to pyrethroids is known to occur e.g. in the peach-potato aphid (Myzus persicae), the Colorado potato beetle (Leptinotarsa decemlineata), several insect pests of oil seed rape such as the pollen beetle (Meligethes aeneus) and in pest insects of stored products. Resistance mechanisms (such as target side resistance or enhanced metabolisation) between different species may differ. In some species like Myzus persicae different resistance mechanisms were detected even in the same individuals.

Information on crops and pests The applicant states that BYDV is spread by Rhopalosiphum padi, but does mention Sitobion avenae or Metopolophium dirhodum only later. All three species have the potential to spread

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BYDV on cereal plants, but BYDV is mainly transmitted by the aphids Rhopalosiphum padi and Sitobion avenae and to a lesser extent Metopolophium dirhodum. Spring applications in au- tumn-sown crops only make sense if aphids survive the winter or if aphid infestation occurs ear- ly. Spring application in spring cereals will be later and generally spring cereals are less com- mon in Germany. Since the virus itself cannot be controlled by chemicals and there are no commercially useful resistant cultivars in Europe, the disease is managed by controlling its aphid vectors with insecticides. The difficulty with visual assessment of BYDV is that WDV is also occurring and that the symptoms in the field are quite similar. Therefore a visual assess- ment cannot clearly distinguish between the 2 viruses. Thus the EPPO Standard PP 1/70 (3) requires that the percentage of BYDV-infected plants is determined on 25 randomly selected plants per plot using ELISA or an equivalent technique.

Information on the intended uses Date: 2018-01-25

Use No. 024222-00/01-001 Field of use Agriculture (field crops) Crop(s)/object(s) wheat (TRZSS), barley (HORVX), oats (AVESS) designated use in crops for grain production except unripe spelt grain Crop stage(s) (BBCH) 12 to 51 Pest(s)/target(s) aphids as virus vectors (APXXSP_3) Area of application Outdoors Timing of application After emergence Max. number of treat- 2 ments for the use Max. number of treat- 2 ments per crop or sea- son Application meth- spraying od/kind of treatment Application rate(s) 0.15 L/ha in 200 to 400 L water/ha Rate App. comment treatments must be at least 7 days apart ------

IIIA1 6.1 Efficacy data The distribution of trials, conducted between 2007 and 2011, to evaluate the efficacy of FU- RY 10 EW in cereals is given in the following map by the applicant. At some of the sites two trials were performed. Trial sites are marked with letters: A: I07BIF.HORVW01 and I07HORVX02-GE01; C: I07HORVX02-GE02; D: FPT-09-4715-FR02; E: I11ZET.HORDX01.UK01 and -UK02; G: I11ZET.HORDX01.UK03 and -UK04; I: I11ZET.HORVX01.FR01; J: JNO 2011-01; K: JNO 2011-02. Altogether 10 trials were performed in winter barley in autumn and one trial in winter wheat in spring.

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The use is intended for wheat, oat and barley. It is unclear why rye is not included in the appli- cation. The preliminary label provided by the applicant also contains a use against cicadellids in cereals. FURY 10 EW is not registered for that use in Germany. Cicadellids are not a damaging sucking pest in cereals, but at least one species (Psammotettix alienus) has importance as virus vectors of WDV in cereals. However, there is no product registered for that use in Germany. The label has to be corrected and adapted to the registered uses.

IIIA1 6.1.1 Preliminary range-finding tests No preliminary range finding tests were performed. The applicant argues that zeta-cypermethrin is an active substance with a long history of intensive use against various pests in various crops in Europe and therefore no information on preliminary trials is given. The applicant concludes that in this specific situation this is considered acceptable, as the dossier is specifically designed to fulfil the requirements of a label extension of the product. In this case the lack of preliminary range finding tests is accepted.

IIIA1 6.1.2 Minimum effective dose tests For minimum effective dose evaluation of FURY 10 EW after autumn application, ten field trials were performed in Belgium, France, the United Kingdom and Germany from 2007 to 2011 to determine the minimum effective dose of the contact insecticide FURY 10 EW against virus transmitting Fehler! Verweisquelle konnte nicht gefunden werden.. Two trials were carried out in Germany in 2007 and two were conducted in France (EPPO maritime zone) in 2008 and 2011. Four trials were conducted in the United Kingdom in 2011 and two were performed in Belgium in 2011. The trials were carried out according to GEP by officially recognised testing organisations. The applicant states that the guidelines EPPO PP 1/70 (3), PP 1/135 (3), PP 1/152 (3), PP 1/181 (3) and CEB 094 were used. The number of minimum effective dose trials in autumn included in the BAD is given in the following table.

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Year 2007 2008 2011 Total Country Belgium - - 2 2 Germany 2 - - 2 France - 1 1 2 United Kingdom - - 4 4 Total 2 1 7 10

The applicant states that the product FURY 10 EW was tested at 0.065 to 0.175 L/ha (6.5 – 17.5 g/ha zeta-cypermethrin) in winter barley for the control of aphids and once in spring in win- ter wheat. Tests for presence of BYDV by ELISA have only been performed in 5 trials. In others no verification of virus occurrence via laboratory methods has been done and the possibility of occurrence of WDV has not been assessed. This cicadellid-transmitted virus is also a common virus in middle Europe, inducing similar symptoms in plants. This cannot be considered as suffi- cient. However, in two trials (I11ZET.HORDX01.UK01, I11ZET.HORDX01.UK02) plants were artificially inoculated with BYDV-infected R. padi. The inoculation was performed as follows: One leaf or tiller infested with virus-infected R. padi was placed along the row over a group of at least eight plants at six locations within the plots. The locations were not randomly chosen. In- stead they were situated 1.5 metre from the shorter side (4 m) and in the centre or 3.0 metre from the ends of the longer side (12 m), respectively. The differences in effectiveness of the various rates tested against R. padi were small. 6.5 g a.s./ha and 7.5 g a.s./ha had lower aphid numbers, but 10 g a.s./ha, 12.5 g a.s./ha and 15 g a.s./ha did not differ markedly, while 17.5 g a.s./ha was again slightly higher. Data were not sig- nificantly different from those achieved by 15 g a.s./ha. However the main goal is the reduction of virus occurrence. The effects of different rates on the virus are not given. Therefore to ensure sufficient aphid control a rate of up to 2 applications of 0.15 L/ha (15 g a.s./ha) is accepted to control aphid virus vectors in cereals. The applicant argues that sometimes more than one application is required. A need for a sec- ond application may arise if an influx of cereal aphids into the crop occurs over an extended period of several weeks. It also can occur both in the autumn and if aphids that have overwin- tered anholocyclic spread again in spring. The latter is common in the maritime climatic zone within the central registration zone. Therefore, a second application may sometimes be neces- sary. An overall summary of different rates of FURY 10 EW (zeta-cypermethrin) against Rhopalosiphum padi on winter barley (2007-2011) is given in the following table.

Control [% of untreated - Abbott]

FURY 10 EW FURY 10 EW FURY 10 EW FURY 10 EW FURY 10 EW FURY 10 EW No. of DA-A (6.5 g a.s./ha) (7.5 g a.s./ha) (10 g a.s./ha) (12.5 g a.s./ha) (15 g a.s./ha) (17.5 g a.s./ha) trials 43.3% 50.0% 66.7% 83.3% 100.0% 116.7%

mean range mean range mean range mean range mean range mean range 55.8- 75.0- 85.7- 64.0- 85.1- 90.1- 1-8* 1-6 71.0 85.0 90.7 88.8 91.8 95.1 86.2 95.1 100.0 100.0 100.0 100.0 72.3- 87.7- 50.0- 50.0- 50.0- 94.5- 1-8* 7-13 80.9 91.7 86.9 87.4 88.3 97.3 89.5 95.8 100.0 100.0 100.0 100.0 72.5- 72.5- 79.8- 75.7- 90.0- 97.7- 1-8* 14-20 85.1 74.8 94.3 93.4 96.6 98.9 97.7 77.1 100.0 100.0 100.0 100.0 83.1- 75.0- 75.0- 3 21-27 - - 93.3 88.1 81.1 - 100.0 100.0 93.2 * No. of trials at 1-6 DA-A, 7-13 DAA 2 2 8 8 8 2 and 14-20 DAA 35.3- 35.3- 35.3- 2 31 - - 49.6 50.2 54.3 - 63.8 65.0 73.3 152- 35.7- 87.0- 61.1- 65.8- 67.9- 85.9- 1-8*1 62.4 90.6 76.5 81.1 83.2 91.8 174 89.1 94.2 96.6 96.1 97.0 97.8 189- 61.9- 78.0- 68.8- 2-5*2 - - 78.3 83.9 83.2 - 194 95.3 100.0 95.3 Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 7 of 37

*1 No. of trials at 2 2 8 8 8 2 152-174 DA-A *2 No. of trials at - - 5 5 5 - 189-194 DA-A

For spring application data from only one trial are available with 3 assessments on the grain aphid Sitobion avenae and a single assessment on birdcherrry-oat aphid Rhopalosiphum padi. Aphid numbers for R. padi were too low for evaluation. Though efficacy was lower at higher rates concerning Sitobion avenae and increased with higher rate concerning visual virus symp- toms, differences were not significant.

Control [% of untreated - Abbott] FURY 10 EW FURY 10 EW FURY 10 EW No. of trials DAA (10 g a.s./ha) (12.5 g a.s./ha) (15 g a.s./ha) 66.6% 83.3% 100.0% Sitobion avenae 1 2 57.2 80.2 71.2 1 11 100.0 93.9 95.0 1 14 100.0 100.0 75.0 BYDV-Symptoms 1 25 8.0 12.9 20.7

IIIA1 6.1.3 Efficacy tests Autumn application In total, 10 field trials were performed in Belgium, northern France, Germany and the United Kingdom between 20007 and 2011 to assess the efficacy of the contact insecticide FURY 10 EW against aphids. These were the same trials as already mentioned for minimum effective dose. Of these trials, two were carried out in Germany in 2007 and two were conducted in northern France (EPPO maritime zone) in 2008 and 2011. Four trials were conducted in the United Kingdom in 2011 and two were performed in Belgium in 2011. The trials were carried out according to GEP by officially recognised testing organisations and the EPPO Standards PP 1/70 (3), PP 1/135 (3), PP 1/152 (3), PP 1/181 (3) as well as CEB guideline 094 were used. In two trials (I11ZET.HORDX01.UK01, I11ZET.HORDX01.UK02) plants were artificially inoculated with virus-infected R. padi. The inoculation was done as follows: One leaf or tiller infested with virus-infected R. padi was placed along the row over a group of at least eight plants at six loca- tions within the plots. The locations were not randomly chosen, but situated 1.5 metre from the shorter side (4 m) and in the centre or 3.0 metre from the ends of the longer side (12 m), re- spectively. Not all reference products were tested in every trial, as shown in the table below.

Aphid control [% of untreated - Abbott]

Decis/Split FURY 10 EW Karate Zeon Karate Zeon Talstar 80 Flo Talstar 80 Flo Decis Protech Protech (15 g a.s./ha) (0.1125 g No. 100% (5 g a.s./ha) (7.5 g a.s./ha) (8 g a.s./ha) (10 g a.s./ha) a.s./ha) (7.5 g a.s./ha) of trials DAA Mean Limits Mean Limits Mean Limits Mean Limits Mean Limits Mean Limits Mean Limits

85.1- 70.4- 85.7- 89.0- 87.9- 78.1- 1-8* 1-6 91.8 100.0 74.8 79.2 91.6 100.0 94.2 100.0 89.3 90.4 87.7 - 88.4 100.0

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50.0- 94.5- 89.4- 83.9- 85.8- 50.0- 1-8* 7-13 88.3 100.0 95.0 95.4 96.1 100.0 94.3 100.0 92.6 96.9 91.6 - 85.4 100.0

14- 90.0- 87.5- 89.0- 77.9- 73.9- 63.5- 1-8* 20 96.6 100.0 89.6 91.7 97.8 100.0 91.2 100.0 90.0 100.0 97.7 - 88.3 100.0

21- 75.0- 75.0- 59.0- 92.1- 51.9- 3 27 81.1 93.2 84.6 100.0 - 84.4 100.0 97.4 100.0 - 67.9 91.0 No. of trials at 1-6 DAA, 7-13 DAA and 14-20 DAA 8 2 6 3 3 1 7

The overall summary of FURY 10 EW (zeta-cypermethrin) effectiveness trial data against barley yellow dwarf virus BYDV on winter barley (HORVW) (2007-2011) is given in the following table. As far as this is recognisable from single trial reports the data include only information on virus occurrence (ELISA) from control plants in most trials, while two trials have been artificially inocu- lated with virus-infected Rhopalosiphum padi. The data in the table below are therefore data from visual assessments. This leads to a difficulty as BYDV and WDV cannot safely be separat- ed by visual assessments and it cannot be excluded fully that also WDV symptoms are as- sessed in some trials.

Virus control [% of untreated - Abbott]

Decis/Split FURY 10 EW Karate Zeon Karate Zeon Talstar 80 Flo Talstar 80 Flo Decis Protech Protech

(15 g a.s./ha) (0.1125 g No. 100% (5 g a.s./ha) (7.5 g a.s./ha) (8 g a.s./ha) (10 g a.s./ha) a.s./ha) (7.5 g a.s./ha) of trials DAA Mean Limits Mean Limits Mean Limits Mean Limits Mean Limits Mean Limits Mean Limits

35.3- 24.6- 35.3- 2 31 54.3 73.3 - 44.4 64.2 - - - 55.2 75.0 152- 67.9- 90.0- 65.8- 40.9- 68.2- 13.6- 1-8*1 174 83.2 97.0 93.0 96.0 80.8 90.2 54.4 67.9 71.8 75.5 93.9 - 71.7 89.3 189- 68.8- 67.5- 65.0- 71.3- 40.0- 2-5*2 194 83.2 95.3 - 83.0 97.7 70.5 76.0 76.0 80.8 - 67.1 85.7 *1 No. of trials at 152-174 DA-A 8 2 6 2 2 1 7 *2 No. of trials at 189-194 DA-A 5 5 - 2 2 - 4

Spring application One field trial was carried out in winter wheat in Germany in 2007 to assess the efficacy of FU- RY 10 EW against aphids after spring application. Again this is the same trial as reported for minimum effective dose testing. The trial was carried out according to GEP by an officially rec- ognised testing organisation and the EPPO Standards PP 1/70 (3), PP 1/135 (3), PP 1/152 (3) and PP 1/181 (3) were used. FURY 10 EW, applied at 0.15 l/ha (15 g a.s./ha) at early infestation in spring, provided similar levels of control of grain aphid Sitobion avenae on winter wheat as the reference products used (Karate Zeon and Talstar 8C) showed similar efficacy. However for R. padi the aphid number is too low for an evaluation with 0.0 -0.1 aphids per sample in the single assessment where the species occurred in this trial after treatment. Therefore the evaluation for R. padi is excluded here.

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Control [% of untreated - Abbott] No. of trials DAA FURY 10 EW Karate Zeon Talstar 8 SC (15 g a.s./ha) (7.5 g a.s./ha) (10 g a.s./ha) Sitobion avenae 1 2 57.2 71.2 70.9 79.2 1 11 100.0 95.0 93.9 93.9 1 14 100.0 75.0 100.0 100.0

A lower dose of 10 g a.s. was also tested. The data on aphid control for that rate are in the chapter on minimum effective dose. The reduction of plant damage caused by BYDV seemed to be different for the 0.10 and 0.15 L/ha doses of FURY 10 EW (8.0% and 20.7%, respectively) with a higher reduction of damage by the higher dose, but not significant. The reference treat- ments reached an efficacy of 18.6 and 18.3% against virus symptoms.

From the data presented by the applicant the assessment generally is quite difficult. Mean aphid numbers of the untreated control have not been given in any of the tables in the dRR and are only in part available from the BAD. Generally 48 or 50 plants per plot were assessed for aphids and occurrence of aphids on these samples in the control varied greatly from 0.2 to 52 in the trials. For the future the applicant should add columns to the tables providing the mean aphid numbers in the untreated control as well as maximum and minimum.

Molecular proof of BYDV occurrence in the trials The EPPO Standard PP 1/70 (3) requires that the percentage of BYDV-infected plants is deter- mined on 25 randomly selected plants per plot using ELISA or an equivalent technique. From 4 trials there are no data on ELISA or a similar technique found in the single trial reports. Further 2 trials have been inoculated with BYDV-infected Rhopalosiphum padi and it is likely that the virus symptoms related to BYDV presence (trials JNO 2011-01 and -02 in the table subsequent- ly submitted by the applicant). The ELISA results from the trials JNO 2011-01 and JNO 2011-02 showed that BYDV-PAV and in one case BYDV-RMV was present in field collected aphids. In 5 trials BYDV has been found and therefore it is likely that visually assessed virus symptoms relate to BYDV presence. In one trial (I11ZET.HORDX01.UK03) the subsequent ELISA test on infected plants in untreated plots (sample taken on 2009-06-04) showed infestation levels of 87.5% infested with BYDV-PAV and 2.78% infested with BYDV-MAV (rounded to 89% infected plants) . In another trial (I07BIF.HORVW01) the ELISA test conducted before application showed 10% infestation of BYDV-PAV and 5% infestation of BYDV-MAV. These results were obtained from a bulk sample mixed across the trial area. For analysis 10 plants were prepared for one single check with ELISA method. At least 10 checks were conducted to get the result. For the ELISA test at 25 DAA 50 single plants per plot were checked separately. The application on 2007-04- 26 showed significant efficacy against aphids, so there was no further propagation of viruses. ELISA tests conducted 25 DAA based on single plants ranged between 45% and 56.5% with 48.5% for the untreated control, 50.5% for the FURY 10 EW treatment with 15 g a.s./ha, 46% for 12.5 g a.s./ha and 56.5% for the lowest rate of 10 g a.s./ha. The references Talstar BC and Karate Zeon reached 47% and 45% respectively. This indicates that in this trial virus occurrence at that date was not affected by treatment against aphids. In a third trial (I07HORVX02-GE02) ELISA has been performed only for the control with 90% infested samples at 195 days after application. A fourth trial (I07HORVX02-GE01) had in the control 35% infested samples at 2007-11-14 and 91% infested samples at 2008-04-22 (180 DAA). In the FURY 10 EW treatment (15 g a.s./ha) only 16% infested samples at 2007-11-14 were found by ELISA. It is not clear from the present-

Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 10 of 37 ed table if the other treatments had no virus or if they were not sampled, but most likely the lat- ter. For a fifth trial (I11ZET.HORDX01.FR01) ELISA results showed that 50% of tested untreated plants were infected by BYDV. Here 4 groups of five plants were sampled at random in each untreated plot at 2011-12-12. These ELISA results were not summarized anywhere in BAD or dRR. This complicated the evaluation unnecessarily, as all single trial reports had to be thoroughly searched. While the data from the single trial reports showed that at least in 7 trials BYDV was present (2 inoculated, 5 proven by ELISA), in none of the trials the cicadellid-transmitted WDV was also determined by ELISA. While this is not explicitly requested in the EPPO Standard 1/70 (3), the symptoms are similar and it cannot be excluded that part of the visual virus symptom assessments also includ- ed WDV-infections. The applicant has provided a more detailed overview as supplementary information. The follow- ing table shows when BYDV was analyzed in the studies.

ELISA Test BYDV infected plants in Trial code performed sample size for ELISA control treatment [%] JNO 2011-01 yes undefined number of aphids * JNO 2011-02 yes undefined number of aphids * I07BIF.HORVW01 yes 25 plants /plot in untreated control 10 (0 DAA) I07HORVX02-GE01 yes 26 plants /plot in untreated control 91 (180 DAA) I07HORVX02-GE02 yes 27 plants /plot in untreated control 90 (180 DAA) FPT-09-4715-FR02 yes not defined 31 (222 DAA) I11ZET.HORDX01.UK01 no # # I11ZET.HORDX01.UK02 no # # I11ZET.HORDX01.UK03 yes 1 subsample from untreated control 89 (92 DAA) I11ZET.HORDX01.UK04 yes 1 subsample from untreated control 100 (92 DAA) I11ZET.HORDX01.FR01 yes 20 plants from untreated control 50 (70 DAA) * virus found in aphids from the trial DAA= days after application

As the EPPO Standard PP 1/70 (3) requires that the percentage of BYDV-infected plants is de- termined on 25 randomly selected plants per plot using ELISA or an equivalent technique, the requirements of the EPPO Standard PP 1/70 (3) are still not fully fulfilled, but for the plants test- ed it has been shown that BDV was present and therefore symptoms reported most likely relate to this virus. However that WDV co-occurred cannot fully be excluded, though BYDV appears to be more widespread in most years in middle Europe.

Conclusion FURY 10 EW at a rate of 15 g a.s./ha appears to have sufficient efficacy against aphids as virus vectors in autumn. The use is acceptable. For spring only data from one single trial from winter are presented. Aphids as virus vectors are less important at that time, but growing conditions and aphid occurrence differ compared to au- tumn, especially when spring cereals are sown. For Germany as zRMS use in spring appears also acceptable. There are no cMS involved.

BBCH stages for applications are not mentioned. Concerning the inclusion of spring application the timing should be until BBCH 51 at latest.

However the situation may be different for other countries in the central registration zone and especially in the maritime climatic zone with longer aphid activity over the colder months and

Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 11 of 37 higher likeliness of anholocyclic overwintering. Such countries would have to decide for them- selves on acceptability of the use in their situation.

IIIA1 6.1.4 Effects on yield and quality

IIIA1 6.1.4.1 Impact on the quality of plants and plant products Under this chapter the applicant refers to the data also presented for IIIA1 6.1.4.3

IIIA1 6.1.4.2 Effects on the processing procedure No residues are present at the time of harvest. Therefore the applicant concludes that any effect on the processing procedure is unlikely.

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products Four field trials were carried out in 2007, 2008 and 2011 to assess the effect of FURY 10 EW on the yield of barley. Two trials were carried out in Germany in 2007, one was conducted in north- ern France (Maritime climatic zone) in 2008 and one was carried out in the United Kingdom in 2011. One further single field trial was carried out in Germany in 2007 to assess the effect of contact insecticide Fehler! Verweisquelle konnte nicht gefunden werden. on the yield of win- ter wheat. FURY 10 EW was applied at doses of 0.10, 0.125 and 0.15 L/ha (10-15 g a.s./ha) in autumn. These treatments were compared to the untreated control and three standards (7.5 g a.s./ha Karate Zeon, 7.5 g a.s./ha Split Protech/Decis Protech and 8 and 10 g a.s./ha of Talstar 80 Flo). Grain yield was calculated at a standard 14% moisture content. No negative effects on yield were found in presence of aphids. Instead under these conditions there was a slight in- crease of 1.1% regarding hectolitre weight in comparison to the untreated control. No significant differences were seen between any of the treatments (including the references and the untreat- ed control) in grain yield, though in average the treatments had slightly higher yields than the control.

IIIA1 6.2 Adverse effects

IIIA1 6.2.1 Phytotoxicity to host crop In total, in ten field trials in barley, performed in Belgium, France, Germany and the UK between 2007 and 2011, phytotoxicity symptoms of the product against Fehler! Verweisquelle konnte nicht gefunden werden. were assessed. Of these trials, two were carried out in Germany in 2007 and two were conducted in France (EPPO maritime zone) in 2008 and 2011. Four trials were conducted in the United Kingdom in 2011 and two were done in Belgium in 2011. In one field trial, performed in Germany in 2007, the phytotoxicity effects of the product on wheat were assessed. The trials were carried out according to GEP by officially recognised testing organisa- tions and the EPPO Standards PP 1/70 (3), PP 1/135 (3), PP 1/152 (3), PP 1/181 (3) and CEB 094 were used. No crop phytotoxicity was seen in any of the trials for any of the treatments, including the reference products.

IIIA1 6.2.2 Adverse effects on health of host animals This is not an EC data requirement.

IIIA1 6.2.3 Adverse effects on site of application This is not an EC data requirement.

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IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) The insecticide Fury 10 EW (100 g a.s./L zeta-cypermethrin) has been proposed for maximal two applications (at least 7 days apart) in cereal species, oil seed rape and pea at a maximum application rate of 0.15 L/ha each (15 g a.s./ha) per crop or season. The control of virus trans- mission by aphids in barley, wheat and oat covered in this document is a label extension.Taking into account the potential disappearance of the active ingredients between the applications, the worst case exposure can be calculated to be approximately 0.285 L a.s./ha (using the maximum default value for the multiple application factor for 2 applications being 1.9 for soil) which corre- sponds to 28.5 g a.s./ha.

Appropriate studies on the potential adverse effects on beneficial arthropods were available from draft Registration Report Part B, Section 6, Annex Point IIIA 10.5 (Effects on Arthropods Other Than Bees) (Core Assessment, March 2014). Furthermore, studies from draft Registra- tion Report Section 6, IIIA 10.5 (National Addendum to application 004222-00/02, February 2011) and draft Registration Report Section 6, IIIA 10.5 (application 004222-00/00, October 2002, ANA2003-86) were used.

The toxicity of Fury 10 EW (Fury 100 EW, Fury) has been investigated by carrying out - a laboratory test on Typhlodromus pyri, - extended laboratory tests on Typhlodromus pyri and Aphidius rhopalosiphi, - an aged residue test on Typhlodromus pyri, - field studies on beneficial arthropods in winter wheat, maize and apple orchards

A further field test with Ripcord (100 g/L cypermethrin) in spring wheat (Shires, 1985) was not evaluated, as the active substance is not identical with zeta-cypermethrin. A previously evaluated laboratory study on Episyrphus balteatus was not valid. A field study on this species, indicating effects > 50% at 100 mL/ha (see application 004222-00/02), was no longer available.

The LR50 for Typhlodromus pyri in the laboratory test was 0.023 g a.s./ha (TP.04/2000, Jansen, 2001). From the extended laboratory tests, the LR50 values were calculated to be 0.085 g a.s./ha for Typhlodromus pyri (20021160/01-NETp, Adelberger, 2002) and 5.48 g a.s./ha for Aphidius rhopalosiphi (20011151/01-NEAp, Bargen, 2001).

In an aged residue test, the test product caused an effect of 100% on Typhlodromus pyri at on fresh residues of 0.04 to 1.3fold the proposed field rate. A full recolonisation was possible three weeks after the application (Table 6.2.4-1). Typhlodromus pyri is not a relevant antagonist in the proposed crops. However, the results indicate that effects between > 50% on populations of relevant predatory mites and spiders are not excluded when the test product is applied accord- ing to the recommended use pattern.

Table 6.2.4-1: Effects of Fury 10 EW (100 g a.s./L) on beneficial arthropods in an aged residue test on potted maize plants Species Rate zeta- Time Corrected Sublethal Reference (Exposed cypermethrin Mortality Effect Stage) [g a.s./ha] [%] (Fecundity) [%] Typhlodromus 1.04 0 DAT 100.0 20021160/02- NETp, pyri 37.5 0 DAT 100.0 (Adelberger, 2003) (protonymphs) 37.5 7 DAT 100.0 37.5 14 DAT 48.9 33.7 37.5 21 DAT 1.1 -37.0

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DAT = days after treatment (0 DAT = fresh residues)

Essential results of the field tests, mainly on the dominant taxa, are presented in Table 6.2.4-2. The studies surveyed a period of 36 d after application in winter wheat, 55 d in apple orchards and about one year in maize. In the field studies in winter wheat and maize, epigaeic arthropods were sampled by pitfall traps (ER-93-08, Brown, 1994, 45541075, Gossmann & Leopold 2011). Foliage dwelling predators were sampled by an eco-VAC Insect Suction Sampler in the field study in maize (45541075, Gossmann & Leopold 2011). In the study in apple orchards (ANA2003-10075, Reboulet, 1993), they were sampled by shaking 3 x 75 branches per treatment. The effects on aphid parasitoids (mostly Aphidius) in winter wheat were investigated by collecting 4 x 10 mummies per plot and recording the emergence. Effects on the population were calculated according to Abbott and partly according to Hender- son-Tilton (if pre-application densities were readable and in case they exceeded 10 animals per treatment).

Table 6.2.4-2: Effects of Fury 10 EW (100 g a.s./L) on beneficial arthropods in field tests in win- ter wheat, apple orchards and maize Species Rate zeta- Crop (Country)/ Effect Abbott* / Reference (Exposed Stage) cypermethrin Time of sampling Henderson-Tilton [g a.s./ha] [%] Winter wheat (UK) Aphid parasitoids, 15 3 daa 33* ER-93-08 mostly Aphidius 11 daa 16* (Brown, 1994) spp. (mummies) 17 daa 24* 24 daa -16* Carabidae (total) 6 daa 44 (A) 16 daa 20 Pterostichus ma- 6 daa 52 didus (Carabidae) 16 daa 59 21 daa 1 Trechus quad- 6 daa 76 ristriatus (Cara- 16 daa 82 bidae) 31 daa 85 36 daa 37 Staphylinidae (A) 6 daa 39 11 daa -4 Staphylinidae 6 daa 19 (La) 11 daa -23 Araneae (total) 6 daa 84 16 daa 53 26 daa 60 36 daa 43 Linyphiidae (total) 6 daa 84 16 daa 77 26 daa 56 31 daa 17 Erigone atra 6 daa 82 (Linyphiidae) 16 daa 57 26 daa 63 31 daa 12 Apple orchard

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(France) Neoseiulus cali- 15 10 daa 100 ANA2003-100 fornicus (predato- 19 daa -32 (Reboulet, ry mite) 1993) Heteroptera (Ori- 10 daa 100 us, Miridae) (A) 19 daa 82 33 daa 40 40 daa -14 Heteroptera (Ori- 10 daa 100 us, Miridae) (Ju) 19 daa 100 33 daa 51 40 daa -62 Stethorus (A) 10 daa 54 (Coccinellidae) 19 daa 76 26 daa -71 Stethorus (La) 19 daa 100 (Coccinellidae) 26 daa -91 Neuroptera (La) 10 daa 100 19 daa 78 26 daa -5 Predatory insects 19 daa 99,9 (total) 26 daa 45 33 daa -17 Maize (D) Aphidius spp. (A) 37.5 2 daa -44* 45541075 14 daa -61* (Goßmann & Chrysopidae (A) 7 daa 0* Leopold 2011) 14 daa 10* 22 daa -32* Chrysopidae (La) 7 daa 67* 14 daa 31* 22 daa 60* 28 daa -16* Anthocoridae 2 daa 100* (Heteroptera, 22 daa 56* A/Ju) 57 daa 19* Coccinella 14 daa 86* septempunctata 21 daa 84* (A) 28 daa 38* 57 daa -75* Coccinellidae (La) 8 daa 97* 28 daa 64* 57 daa -50* Pterostichus 4 daa 68* melanarius (A) 10 daa 5* (Carabidae) 17 daa 36* 27 daa 23* Bembidion 4 daa 56* lampros (A) 10 daa -55* (Carabidae) Aleocharinae 4 daa 6* (Staphylinidae) 17 daa -67*

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Oedothorax api- 4 daa 74* catus (Linyphi- 10 daa 93* idae, pitfall trap) 27 daa 97* 73 daa 67* Erigone atra 4 daa 85* (Linyphiidae, pit- 17 daa 100* fall trap) 27 daa 97* 59 daa 0* Meioneta rurestris 10 daa 87* (Linyphiidae, pit- 17 daa 43* fall trap) 27 daa -17* 59 daa 100* Pardosa agrestis 10 daa 100* (Lycosidae, pitfall 27 daa 100* trap) 346(!) daa 80* A = adults, La = larvae, Ju = juvenile daa = days after application

The effect of 0.5fold the maximal proposed rate of the test product on established Aphidius mummies in winter wheat was 33% at the sampling 3 d after application, mostly due to oral poi- soning during emergence. This effect is obviously negligible, as the following results of the field test in maize show. In the field test in maize, an increase of adult Aphidius and other braconids (suction sampling) was recorded at 1.3fold the maximal proposed rate of the test product.

On carabidae (total), the test product showed an acute effect (calculated according to Hender- son-Tilton) between 25 - 50% at 0.5fold the maximal proposed rate in winter wheat. The effect dropped below 25% 16 d after application. However, on single species as Pterostichus madidus and Trechus quadristriatus, respectively, effects > 50% persisted over 16 and 31 d. The field test in maize at 1.3fold the proposed field rate showed an effect > 50% on the domi- nant carabid species Pterostichus melanarius and its full recovery within 1 month. Three other abundant carabid beetle species were less affected.

The acute effect of the test product at 0.5fold the maximal proposed rate on adult staphylinidae in winter wheat was in the range between 25 - 50%. As the activity density was restored 11 d after application, the effect can be considered as transient knock down effect. Staphylinid larvae were not affected. In the field test in maize at 1.3fold the proposed field rate, the abundance of rove beetles was low, but there were no indications for effects ≥ 25%.

Spiders (Araneae total and Linyphiidae) showed effects > 50% up to and including at least 26 d after application at 0.5fold the maximal proposed rate in winter wheat. 31 d after application the effect on the Araneae population was still in the range between 25 - 50%, while linyphiid species as Erigone atra fully recovered. In the field test in maize, 1.3fold the proposed field rate caused strong effects > 50% on domi- nant araneae taxa lasting partly longer than 10 weeks. The NOER was 1.04 g a.s./ha (drift rate). Recovery of juveniles and adults, respectively, could not be demonstrated within one growing season and one year after application, respectively (Goßmann & Leopold 2011).

The field test in apple orchard (France, not in the central zone) confirmed the high toxicity of the test product to further foliage dwelling beneficial arthropods. At only 0.5fold the maximal pro- posed rate, effects > 50% persisted over 10 d with the predatory mite Neoseiulus californicus, over 19 d with larvae of Stethorus and Neuroptera, and over 33 d with Heteroptera. A full recov- ery of all sampled predatory insects was possible about 5 weeks after application. Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 16 of 37

In the field test in maize, 1.3fold the proposed field rate caused effects > 50% on juvenile and adult coccinellids lasting longer than 10 weeks (Goßmann & Leopold, 2011). Adult Chrysopidae were not affected, while juveniles showed effects > 50% up to and including 22 d after applica- tion.

Classification scheme of the effects: Laboratory tests on artificial substrates (glass, quartz sand) < 30% = not harmful 30 – 80% = slightly harmful > 80% = harmful Extended laboratory tests on natural substrates, semi-field and field tests < 25% = not harmful 25 – 50% = slightly harmful > 50% = harmful

Proposal for classification:

Fury 10 EW is classified as - not harmful for populations of Aphidius spp. and other Braconidae - not harmful for populations of Staphylinidae, - harmful for populations of Pterostichus madidus and Trechus quadristriatus (Carabidae), - harmful for populations of Coccinella septempunctata and other Coccinellidae - harmful for populations of Orius and other Anthocoridae - harmful for populations of Chrysopidae - harmful for populations of relevant predatory mites and spiders

Adverse effects on soil quality indicators (e. g. microorganisms, earthworms) are considered in Section 6 Ecotoxicological Studies in the Registration Report.

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes The applicant states that this is not required for FURY 10 EW as zeta-cypermethrin is an insec- ticide and does not interfere with plant growth processes. The applicant also argues that since commercialisation, no problems have been observed on crops used for propagating purposes where products containing this active substance have been applied. This argumentation is ac- cepted.

IIIA1 6.2.6 Impact on succeeding crops The applicant provides no data but argues that for all foliar applied pyrethroids, including FURY 10 EW, the residual activity is limited and therefore cannot impact any succeeding crop.

IIIA1 6.2.7 Impact on other plants including adjacent crops The applicant provides no data but states that the pyrethroid zeta-cypermethrin has no herbicid- al activity and there is no record, during the years of use of products containing this active sub- stance of phytotoxicity occurring in adjacent crops or other plants. Therefore, applications will not have any negative effects on other plants including adjacent crops. While the argumentation may be acceptable, the statement that there are no data is essentially incorrect, There are data available on non target plants from document M section 6, which the applicant could use for argumentation (see also EPPO Standard PP1/256)..

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IIIA1 6.2.8 Possible development of resistance or cross-resistance For cereal aphids resistance against pyrethroids is up to now only known in the species Sitobion avenae, the grain aphid. Knock down resistance has been shown to exist in the United Kingdom and reductions in control are also known from there. The KDR-mutation has also been found in Germany recently. No pyrethroid resistance is yet known for Rhopalosiphum padi and Metopolophium dirhodum.

IIIA1 6.3 Economics This is not an EC data requirement.

IIIA1 6.4 Benefits

IIIA1 6.4.1 Survey of alternative pest control measures This is not an EC data requirement.

IIIA1 6.4.2 Compatibility with current management practices including IPM This is not an EC data requirement.

IIIA1 6.4.3 Contribution to risk reduction This is not an EC data requirement.

IIIA1 6.5 Other/special studies No studies were submitted.

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 For assessment of efficacy of FURY 10 EW, 10 autumn field trials in winter barley were per- formed in Belgium, northern France, Germany and the United Kingdom between 2007 and 2011 to assess the efficacy of the contact insecticide FURY 10 EW against aphids. Of these trials, two were carried out in Germany in 2007 and two were conducted in northern France (EPPO maritime zone) in 2008 and 2011. Four trials were conducted in the United Kingdom in 2011 and two were performed in Belgium in 2011. An 11th trial was performed in Germany in spring 2007 in winter wheat. The trials were carried out according to GEP by officially recognised test- ing organisations and the EPPO Standards PP 1/70 (3), PP 1/135 (3), PP 1/152 (3), PP 1/181 (3) as well as CEB guideline 094 were used. Efficacy of the test product against aphids was comparable to registered reference treatments. Lower and higher rates were also tested. Clear- ly lower rates of 6.5 and 7.5 g a.s. /ha resulted in reduced aphid control, while rates of 10 and 12.5 g a.s./ha did not differ markedly from 15 g a.s./ha. Concerning assessment of visual virus infection on plants the efficacy from 15 g a.s./ha was also sufficient with for example in average 83.2% compared to 83.0% (7.5 g a.s./ha Karate Zeon) 184-193 days after application. While the reduction of plant damage caused by BYDV was not significantly different between the rates of 10 and 15 g a.s./ha. In addition, the reduction of plant damage caused by BYDV was not signifi- cantly different between the plots treated with the test product and reference products. Concern- ing the occurrence of BYDV in the trials, EPPO Standard PP 1/70 (3) demands that the per- centage of BYDV-infected plants is determined on 25 randomly selected plants per plot using ELISA or an equivalent technique. This has not been performed according to the EPPO Stand- ard in the trials but virus occurrence has been shown. The product appears to have no negative effects on cereal yield, does not seem to induce phy- totoxicity symptoms in any trial and appears unlikely to affect plant parts used for propagation or

Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 18 of 37 other plants including adjacent crops. However the situation should be reassessed with the help of the non target plant data. Grain aphid Sitobion avenae is known to have developed pyrethroid resistance, but not the oth- er two common cereal aphids Rhopalosiphum padi and Metopolophium dirhodum. FURY 10 EW at a rate of 15 g a. s./ha has sufficient efficacy against aphids as virus vectors in autumn and spring. BBCH stages for applications are not mentioned. Concerning the inclusion of spring application the timing should be until BBCH 51 at latest. For spring only data from one single trial from winter are presented. Aphids as virus vectors are less important at that time, but growing conditions and aphid occurrence differ compared to au- tumn, especially when spring cereals are sown. For Germany use in spring appears also ac- ceptable. The use could possibly therefore also be accepted for Germany as zRMS. There are no cMS involved. The situation may be different for other countries in the central registration zone and will be different especially in the maritime climatic zone with longer aphid activity over the colder months and higher likeliness of anholocyclic overwintering. Such countries would have to decide for themselves on acceptability of the use in their situation.

However, the EPPO Standard PP 1/70 (3) requires that the percentage of BYDV-infected plants is determined on 25 randomly selected plants per plot using ELISA or an equivalent technique. This has only partly been done and was not summarized in the original submission by the appli- cant. The applicant has now summarised information on assessments and shown the presence of BYDV in the trials with the exception of two trials where no ELISA were performed. It still can not fully be excluded that WDV may have also been present. In future the applicant should pre- sent complete data on virus occurrence from the beginning.

Use instructions on the label have to be adapted to the registered uses. The label sent contains uses not approved in Germany.

On the basis of field tests, effects > 50% are expected for populations of relevant taxa of benefi- cial insects, predatory mites and spiders, when Fury 10 EW is applied according to the recom- mended use pattern (i.e. 2 x 0.15 L/ha) to cereals.

IIIA1 6.7 List of test facilities including the corresponding certificates Country Affiliation/ Trial no. Year Address testing facility DE Agrostat GmbH I07BIF.HORVW01 2007 AGROSTAT GmbH In den Gruben 6 I07HORVX02-GE01 2007 74572 Blaufelden-Herrentierbach I07HORVX02-GE02 2007 GERMANY FR FPT-09-4715-FR02 2008 Investigator (FPT-09-4715-FR02): STAPHYT Route de Moeuvres 62860 Inchy en Artois FRANCE FR SynTech Re- I11ZET.HORVX01.FR01 2011 SynTech Research France S.A.S search France 613 route du Bois de Loyse S.A.S 71570 La Chapelle de Guinchay FRANCE UK SynTech Re- I11ZET.HORDX01.UK01 2011 SynTech Research UK search UK I11ZET.HORDX01.UK02 2011 Common Farm I11ZET.HORDX01.UK03 2011 Hopton, Norfolk IP22 2RG I11ZET.HORDX01.UK04 2011 UNITED KINGDOM BE Centre wallon JNO 2011-01 2011 Centre wallon de Recherches

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de Recherches JNO 2011-02 2011 agronomiques agronomiques Département Sciences du Vivant Unité Protection des Platnes et Écotoxicologie Rue du Bordia, 11 B-5030 Gembloux BELGIUM

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Appendix 1: List of data submitted in support of the evaluation List of data submitted by the applicant and relied on Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Anonymous 2013 Gebrauchsanleitung N J FMC 3.9 k.A. O/O N 2572947/435015 KIIIA1 Anonymous 2013 Gebrauchsanleitung N J FMC 3.9 k.A. O/O N 2572948/435016 KIIIA1 Anonymous 2013 Gebrauchsanleitung N J FMC 3.9 k.A. O/O N 2572949/435017

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Anonymous 2013 Gebrauchsanleitung N J FMC 3.9 none k.A. O/O N 2572950/435018 KIIIA1 6 TSGE 2013 Biological Assessment Dossier, Label extension: cereals* N J FMC Deutschland virus vector aphids GmbH zet-eucentral-Fury10EWBYDV 201 k.A. N/N N 2572951/435019 KIIIA1 6 TSGE 2013 Biological Assessment Dossier, Label extension: cereals* N J FMC Deutschland virus vector aphids GmbH k.A. N/N N 2572952/435020 KIIIA1 De Proft, M. 2012 Efficacy evaluation of FURY 10 EW, insectivide containing N J FMC 6.1.2 100g zetacypermethrin/L against aphids vector of BYDV (barley yellow dwarft virus) in winter barley JNO 2011 25

J/N N 2572953/435021 Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 22 of 37

Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 De Proft, M. 2012 Efficacy evaluation of FURY 10 EW, insectivide containing N J FMC 6.1.2 100g zetacypermethrin/L against aphids vector of BYDV (barley yellow dwarft virus) in winter barley JNO 2011-02 k.A. J/N N 2572954/435022 KIIIA1 Tiggemann, B. 2007 Efficacy of TALST AR 8 SC (bifenthrin, 80 gai/L SC) on N J FMC 6.1.2 virus vector control in winter cereals, spring application, Germany 2007 I07BIF.HORVW01 k.A. J/N N 2572955/435023 KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.1.2 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE01 k.A. J/N N 2572956/435024

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.1.2 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE02 k.A. J/N N 2572957/435025 KIIIA1 Schmidt, I. 2009 Efficacy of FURY 10EW (zeta-cypermethrin, 100g/L EW) N J FMC 6.1.2 and TALSTAR FLO (bifenthrin 80g/L SC) on BYDV transmitting aphids in barley. France 2008/2009 FPT-09-4715-FR02 k.A. J/N N 2572958/435026 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.2 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK01 k.A. N/J N 2572959/435027

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.2 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK02 k.A. N/J N 2572960/435028 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.2 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK03 k.A. N/J N 2572961/435029 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.2 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK04 k.A. N/J N 2572962/435030 KIIIA1 Gales, J. 2013 EFFICACY OF FURY 10 EW(ZETACYPERMETHRIN 100 N J FMC 6.1.2 G/L EW) ON BYDV TRANSMITTING APHIDS IN BARLEY I11ZET.HORVX01.FR01 k.A. N/J N 2572963/435031 Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 25 of 37

Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 De Proft, M. 2012 Efficacy evaluation of FURY 10EW, insecticide containing N J FMC 6.1.3 100g zetacypermethrin/L against aphids vector od BYDV (barley yellow dwarft virus) in winter barley JNO 2011-01 k.A. J/N N 2572964/435033 KIIIA1 De Proft, M. 2012 Efficacy evaluation of FURY 10EW, insecticide containing N J FMC 6.1.3 100g zetacypermethrin/L against aphids vector od BYDV (barley yellow dwarft virus) in winter barley JNO 2011-02 k.A. J/N N 2572965/435034 KIIIA1 Tiggemann, B. 2007 Efficacy of TALST AR 8 SC (bifenthrin, 80 gai/L SC) on N J FMC 6.1.3 virus vector control in winter cereals, spring application, Germany 2007 I07BIF.HORVW01 k.A. J/N N 2572966/435035

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.1.3 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE01 k.A. J/N N 2572967/435036 KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.1.3 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE02 k.A. J/N N 2572968/435037 KIIIA1 Schmidt, I. 2009 Efficacy of FURY 10EW (zeta-cypermethrin, 100 g/L) and N J FMC 6.1.3 TALSTAR FLO (bifenthrin, 80g/L SC) on BYDV transmitting aphids in barley. France 2008/2009 FPT-09-4715-FR02 k.A. J/N N 2572969/435039

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.3 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK01 k.A. N/J N 2572970/435040 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.3 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK02 k.A. N/J N 2572971/435041 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.3 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK03 k.A. N/J N 2572972/435042 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.3 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK04 k.A. N/J N 2572973/435043 Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 28 of 37

Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Gales, J. 2013 EFFICACY OF FURY 10 EW (ZETACYPERMETHRIN 100 N J FMC 6.1.3 G/L EW)ON BYDV TRANSMITTING APHIDS IN BARLEY I11ZET.HORVX01.FR01 k.A. N/J N 2572974/435044 KIIIA1 Tiggemann, B. 2007 Efficacy of TALST AR 8 SC (bifenthrin, 80 gai/L SC) on N J FMC 6.1.4.3 virus vector control in winter cereals, spring application, Germany 2007 I07BIF.HORVW01 k.A. J/N N 2572975/435045 KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.1.4.3 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE01 k.A. J/N N 2572976/435046

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.1.4.3 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE02 k.A. J/N N 2572977/435047 KIIIA1 Schmidt, I. 2009 Efficacy of FURY 10 EW (zeta-cypermethrin, 100g/L EW) N J FMC 6.1.4.3 and TALSTAR FLO (bifenthrin, 80 g/L SC) on BYDV transmitting aphids in barley. France 2008/2009 FPT-09-4715-FR02 k.A. J/N N 2572978/435048 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.1.4.3 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK01 k.A. N/J N 2572979/435050

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Tiggemann, B. 2007 Efficacy of TALST AR 8 SC (bifenthrin, 80 gai/L SC) on N J FMC 6.2.1 virus vector control in winter cereals, spring application, Germany 2007 I07BIF.HORVW01 k.A. J/N N 2572980/435051 KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.2.1 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE01 k.A. J/N N 2572981/435052 KIIIA1 Tiggemann, B. 2008 Efficacy and selectivity evaluation of FURY 10EW (100 g/L N J FMC 6.2.1 zeta-cypermethrin EW) and Talstar Flo (80g/L bifenthrin SC) against aphids (virus vector control) in winter barley. Germany 2007/2008 I07HORVX02-GE02 k.A. J/N N 2572982/435053

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Schmidt, I. 2009 Efficacy of FURY 10EW (zeta-cypermethrin, 100g/L EW) N J FMC 6.2.1 and TALSTAR FLO (bifenthrin, 80 g/L SC) on BYDV transmitting aphids in barley. France 200/2009 FPT-09-4715-FR02 k.A. J/N N 2572983/435054 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.2.1 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK01 k.A. N/J N 2572984/435055 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.2.1 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK02 k.A. N/J N 2572985/435056

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.2.1 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK03 k.A. N/J N 2572986/435057 KIIIA1 Calloway, J. 2013 Efficacy of FURY 10 EW (zetacypermethrin 100 g/l EW) on N J FMC 6.2.1 BYDV transmitting aphids in barley. 2011 I11ZET.HORDX01.UK04 k.A. N/J N 2572987/435058 KIIIA1 Gales, J. 2013 EFFICACY OF FURY 10 EW (ZETACYPERMETHRIN 100 N J FMC 6.2.1 G/L EW)ON BYDV TRANSMITTING APHIDS IN BARLEY I11ZET.HORVX01.FR01 k.A. N/J N 2572988/435059 MIIIA1 Anonymous 2013 dRR - B7 - core assess. - DE - 024222-00/01 - Fury 10EW N J FMC Sec 7 none k.A. O/O N 2572990/435060

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Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. MIIIA1 Anonymous 2013 dRR - B7 - core assess. - DE - 024222-00/01 - Fury 10EW N J FMC Sec 7 none k.A. O/O N 2572991/435061 KIIIA1 Brown, K.C. 1994 The effects of FURY 10EW on beneficial arthropods in N J FMC 10.5.2 cereals 93.08

J/O N 2656875/435063 KIIIA1 Shires, S.W. 1985 A comparison of the effects of Cypermethrin, Parathion- N N LIT 10.5.2 methyl and DDT on cereal aphids, predatory beetles, earthworms and litter decomposition in spring wheat k.A. Crop Protection N/O J 2656885/435065 KIIIA1 Tisseur, M. 1994 Toxicite a court terme vis a vis des abeilles evaluee sous N J FMC 10.5.4 and Budin, P. tunnels

N/O N 2657010/435073 Julius Kühn-Institut 2018-08-27 Part B – Section 7 FURY 10 EW Registration Report Core Assessment ZV1 024222-00/01 Central Zone Page 34 of 37

Data Author(s) Year Title Vertebrate Data protec- Justification if Owner Point Report-No. study tion claimed data protection Source (J=Yes (J=Yes is claimed GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI-No. KIIIA1 Tisseur, M. 1995 Toxicite a court terme vis a vis abeilles evaluee sous N J FMC 10.5.4 and Budin, P. tunnels du Fury 10 EW

N/O N 2657022/435075 KIIIA1 Reboulet, J.N. 1993 Evaluation of the medium-term proctical effects of Fury and N J FMC 10.5.2 Talstar F10 (FMC EUROPE NV) on the predators of the red acarid (Panonychus ulmi) in apple tree orchards

N/O N 2657025/435076 KIIIA1 Anonymous 2017 Informationen zur Virusbestimmung N J Cheminova 6.1.3 Deutschland

O/N N 3461088/522328 KIIIA1 Anonymous 2017 Auswirkungen auf angrenzende Kulturen N J Cheminova 6.2.7 Deutschland

O/N N 3461097/522329

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List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review Data Author(s) Year Title Vertebrate Data protection Justification if data protection is Owner Point Report-No. study claimed claimed Source (J=Yes Y/N GLP/GEP O=Open Published N=No) Authority registration No./JKI- No.

List of data submitted by the applicant and not relied on Data Author(s) Year Title Vertebrate Data protection Justification if data protection is Owner Point Report-No. study claimed claimed Source (J=Yes Y/N GLP/GEP O=Open Published N=No) Authority registration No./JKI- No.

List of data relied on and not submitted by the applicant but necessary for evaluation Data Author(s) Year Title Vertebrate Data protection Justification if data protection is Owner Point Report-No. study claimed claimed Source (J=Yes Y/N GLP/GEP O=Open Published N=No) Authority registration No./JKI- No.

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Appendix 2: GAP table GAP-Table of intended uses for Germany

GAP rev. (2), date: 2016-08-17

PPP (product name/code) FURY 10 EW Formulation type: EW active substance zeta-Cypermethrin Conc. of as : 100g/l

Applicant: FMC Chemical sprl professional use Zone(s): Germany non professional use

Verified by MS: Yes

1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Member Crop and/ F Pests or Group of Application Application rate PHI Remarks: No. state(s) or situation G pests controlled (days or Method / Timing / Growth Max. number kg, L product / g, kg as/ha Water L/ha ) e.g. safener/synergist per (crop destination / I (additionally: develop- Kind stage of crop & (min. interval ha ha purpose of crop) mental stages of the season between a) max. rate a) max. rate min / max pest or pest group) applications) per appl. per appl. e.g. recommended or mandatory tank mixtures a) per use b) max. total b) max. total b) per crop/ rate per rate per season crop/season crop/season 001 DE Wheat (TRZSS), Oats F Aphids as virus vectors Spraying BBCH 12-51 a) 2 (treat- a) 0.15 l/ha a) 15 g as/ha 200-400 28 (AVESS), Barley ments must be b) 0.3 l/ha b) 30 gas/ha l/ha (HORVX) at least 7 days apart) b) 2 (treat- ments must be at least 7 days apart)

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Re- (1) Numeration of uses in accordance with the application/as verified by MS (8) The maximum number of applications possible under practical conditions of use for marks: (2) Member State(s) or zone for which use is applied for each single application and per year (permanent crops) or crop (annual crops) must (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the be provided use situation should be described (e.g. fumigation of a structure) (8) Min. interval between applications (days) were relevant (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (10) The application rate of the product a) max. rate per appl. and b) max. total rate per (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental crop/season stages must be given in metric units (e.g. kg or L product / ha) (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - (11) The application rate of the active substance a) max. rate per appl. and b) max. total type of equipment used must be indicated rate per (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, crop/season must be given in metric units (e.g. g or kg / ha) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at (12) The range (min/max) of water volume under practical conditions of use must be given time of application (L/ha) (13) PHI - minimum pre-harvest interval (14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.

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