Het College Voor De Toelating Van Gewasbeschermingsmiddelen En Biociden

13404 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT Op 28 oktober 2014 is van

Bayer CropScience S.A.-N.V. Postbus 231 3640 AE MIJDRECHT

een vrijwillig zonale aanvraag ontvangen tot herregistratie van de toelating voor het gewasbeschermingsmiddel

MOVENTO op basis van de werkzame stof spirotetramat. Nederland is in deze een betrokken lidstaat, als bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is Oostenrijk voor de centrale zone en Griekenland voor de interzonale zone.

Bij de herregistratie zijn tevens uitbreidingen met toepassingen in aardappel, aardbei (productie), aalbessen, steenvruchten, sjalotten en bloemisterijgewassen, en nieuwe claims tegen koolgalmug en trips in koolgewassen aangevraagd. In de loop van de beoordelingsprocedure heeft de aanvrager de bestaande gebruiken in boon met peul, erwt met peul en hop en de aangevraagde claims tegen koolgalmug en trips in koolgewassen teruggetrokken uit de aanvraag.

HET COLLEGE BESLUIT tot Afwijzing van de herregistratie en uitbreiding van de toelating van bovenstaand middel voor het aangevraagde professionele gebruik in aalbessen Toelating van de herregistratie en uitbreiding van de toelating van bovenstaand middel voor de overige aangevraagde gebruiken.

Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel van dit besluit.

1.1 Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

1.2 Gebruik Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

MOVENTO, 20146453 NLTHG 13404 N

1.3 Classificatie en etikettering Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden vermeld:

° De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie” in bijlage I. ° Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I. ° Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. ° De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2 van deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode) Bij de herregistratie wordt het etiket omgezet van WG format 2.0 naar WG format 2.1. Om tot een acceptabel risico te komen worden nieuwe drift beperkende maatregelen in het WG opgenomen ter bescherming van bijen, niet-doelwit arthropoden en niet-doelwit planten. Ook wordt een nieuw voorschrift tegen vervoederen van vezelgewassen en een nieuwe zin voor resistentiemanagement toegevoegd. Daarom wordt een nieuwe versie van het WG vastgesteld met volgnummer W.5. Omdat het nieuwe WG wordt beperkt zijn respijttermijnen van toepassing voor verpakkingen met het oude etiket met volgnummer W.3 en W.4.

Aanvrager verzoekt maximale aflevertermijn en beperkte opgebruiktermijn van 6 maanden toe te kennen voor verpakkingen met het oude etiket, om de voorraden in de keten via afleveren en opgebruik af te kunnen bouwen. De aanpassingen van het WG met nieuwe toepassingsvoorwaarden zijn noodzakelijk om een acceptabel risico aan te tonen op basis van modelberekeningen. Er is echter geen sprake van aantoonbare risico’s en daarom is er wel ruimte voor beperkte respijttermijnen zodat gebruikers het product met het oude WG kunnen blijven gebruiken en opmaken. Het middel wordt in de aanstaande winterperiode niet gebruikt. Daarom wordt een aflevertermijn van 6 maanden voorgesteld met aansluitend een beperkte opgebruiktermijn van 6 maanden. Dit is conform het voorstel van de aanvrager.

Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. De te hanteren w-coderingen en afleveren opgebruiktermijnen voor oude verpakkingen zoals vastgesteld volgens het besluit beleidsregel respijttermijnen voor gewasbeschermingsmiddelen (Staatscourant 31 augustus 2016) staan vermeld onder “toelatingsinformatie” in bijlage I.

2. WETTELIJKE GRONDSLAG Besluit Artikel 80, vijfde lid juncto artikel 128 Wgb (oud) Classificatie en etikettering artikel 31 en artike l 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader De beoordeling van deze aanvraag is conform Bgb en Rgb d.d. 1 3 juni 2011 en Evaluation Manuaal 1.1.

MOVENTO, 20146453 NLTHG 13404 N

3. BEOORDELINGEN 3.1 Fysische en chemische eigenschappen De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is va stgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht.

3.2 Analysemethoden De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik.

3.3 Risico voor de mens Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is.

Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het registration report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel bekendmaken delen A en B van het Registration Report.

Bezwaarmogelijkheid Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

Ede, 31 oktober 2018

Het College voor de toelating van gewasbeschermingsmiddelen en biociden, voor deze: de voorzitter,

Ir. J.F. de Leeuw

MOVENTO, 20146453 NLTHG 13404 N BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20146453 NLTHG Type aanvraag: Vrijwillig zonale aanvraag tot herregistratie van gewasbeschermingsmiddeltoelating met Nederland als betrokken lidstaat Middelnaam: MOVENTO Verzenddatum aanv raag: 28 oktober 2014 Formele registratiedatum: * 2 december 2014 Datum in behandeling name: 20 januari 2017 Datum compliance check: 29 augustus 2014

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.

2.2 Stofinformatie

Werkzame stof Gehalte spirotetramat 150 G/L

• De stof is per 1 mei 2014 goedgekeurd volgens Verordening (EU) 1107/2009 (Uitvoeringsverordening (EU) No 1177/2013 d.d. 20 november 2013). De goedkeuring van deze werkzame stof expireert op 30 april 2024.

2.3 Toelatingsinformatie

Toelatingsnummer: 13404 N Expiratiedatum: 30 april 2025 Afgeleide parallel of origineel: n.v.t. Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewas beschermingsmiddel Gebruikers: Professioneel

W-coderingen en afleveren opgebruiktermijnen:

° W-codering professioneel gebruik: 5 ° Vorige w -codering professioneel gebruik: 3 en 4 ° Aflevertermijn professioneel gebruik: 6 maanden (tot 2 mei 2019) ° Opgebruiktermijn professioneel gebruik: 6 maanden (tot 2 november 2019)

2.4 Verpakkingsinformatie

Aard van het preparaat: Olie dispersie

MOVENTO, 20146453 NLTHG 13404 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel MOVENTO

Professioneel gebruik de identiteit van alle stoffen in het mengse l die bijdragen tot de indeling van het mengsel: spirotetramat Pictogram GHS07 GHS08 GHS09 Signaalwoord Waarschuwing Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken. H319 Veroorzaakt ernstige oogirritatie. H361fd Wordt ervan verdacht de vruchtbaarheid te schaden. Wordt ervan verdacht het ongeboren kind te schaden. H411 Giftig voor in het water levende organismen, met langdurige gevolgen. Voorzorgsmaatregelen P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. P308 + P311 Na (mogelijke) blootstelling: een ANTIGIFCENTRUM/arts/... raadplegen. P501 Inhoud/verpakking afvoeren naar .... SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt. Aanvullende EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke etiketelementen gezondheid en het milieu te voorkomen. Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee

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REGISTRATION REPORT Part A

Risk Management

Product name: MOVENTO

Product code: 102000016434 Active Substance: Spirotetramat OD 150 (150 g/L)

Country: The Netherlands Central Zone Zonal Rapporteur Member State: Austria Inter Zone Zonal Rapporteur Member State: Greece

NATIONAL ASSESSMENT

Applicant: Bayer CropScience SA-NV Date: October 2018

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 2 of 114

OECD Statement on Confidentiality

The summaries and evaluations contained in this monograph or review report may be based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority that prepared it. Other registration authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this Monograph or review report unless they have received the data on which the summaries and evaluation are based, either:

• From the owner of the data; or • From a second party that has obtained permission from the owner of the data for this purpose or, alternatively, the applicant has received permission from the data owner that the summaries and evaluation contained in this Monograph or review report may be used in lieu of the data; or • Following expiry of any period of exclusive use, by offering – in certain jurisdictions – mandatory compensation; unless the period of protection of the proprietary data concerned has expired.

Applicants wishing to avail of information in this Monograph or review report should seek advice from the regulatory authority to which application is made concerning the requirements in their country.

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Tabel of Contents PART A – Risk Management ...... 4

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 4 of 114

PART A – Risk Management This document describes the acceptable use conditions required for the re-authorization of MOVENTO containing spirotetramat in The Netherlands . This evaluation is required subsequent to the EU approval of spirotetramat.

The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for The Netherlands. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national re-registration by the EU review. It also includes assessment of data and information relating to MOVENTO where that data has not been considered in the EU review. Otherwise assessments for the safe use of MOVENTO have been made using endpoints agreed in the EU review of spirotetramat.

This document describes the specific conditions of use and labelling required for The Netherlands for the re-authorization of MOVENTO.

Appendix 1 of this document is a copy of the approved product label for The Netherlands. Appendix 2 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. Appendix 3 contains a list of data relied on for this submission.

1. Details of the application

1.1. Application background This application was submitted by Bayer CropScience SA-NV in October 2014.

The application was for authorization of MOVENTO, an oil dispersion containing 150 grams of spirotetramat per liter for use as an insecticide in agriculture or horticulture.

1.2. Annex I inclusion Spirotetramat was EU approved in accordance with Regulation (EC) No 1107/2009 under Implementing Reglation (EU) No 1177/2013 which shall apply from 1 May 2014.

The Regulation (EU) No 1177/2013 provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.

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 spirotetramat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to insectivorous birds. This concern was addressed in the submission.

1.3. Regulatory approach To obtain authorization of the product MOVENTO, the active substance must meet the conditions of Directive 91/414/EEC 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.

The EFSA Scientific Report for spirotetramat (EFSA Journal 2013;11(6):3243) is considered to provide the relevant scientific information for the review of the product.

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In addition, as stated in the Regulation (EU) No 1177/2013, the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled for spirotetramat and Directive 91/414/EEC is to apply with respect to the procedure and the conditions for approval of this active substance. As a result, this dossier is prepared to fulfil the requirements for re-authorization of existing uses at the date of Entry Into Force of Regulation (EU) 1177/2013 (1 May 2014) of the spirotetramat containing preparations as well as for extensions of use.

This application was submitted in order to allow the authorization of this product in The Netherlands in accordance with the above.

MOVENTO (Specification No.102000016434) was not the representative formulation for the the inclusion of spirotetramat into the Annex to Implementing Regulation (EU) No. 540/2011 (the representative formulation was also an OD 150 but with a slightly different composition Specification No.102000011380). Since the formulation has not been previously evaluated according to Uniform Principles at European level, detailed summaries of the studies have been provided. Accordingly, copies of the reports of all studies required for the evaluation have been provided in this submission.

1.4. Data protection claims The reference list included in the dossier defines the list of studies and reports, submitted with the application, for which a claim for data protection was made. This claim for protection was made as the studies and reports were submitted and used as the basis for approval for the first time in The Netherlands. Based on Article 59 of Regulation (EC) 1107/2009 Bayer S.A.S. (Bayer CropScience) claim 10 years protection for these studies and reports. The authority confirms that these studies and reports are protected for 10 years from the data of authorisation of the product and thus cannot be used for the benefit of another applicant.

1.5. Letters of Access The applicant has access to any protected studies required for the evaluation of the product or has provided sufficient data to show that access is not required.

2. Details of the authorisation

2.1. Product identity

Product Name MOVENTO Specification n°102000016434-02 Spirotetramat OD 150 (150 g/L) MOVENTO 150 OD Authorization Number 13404 N (for re-registration) Function Insecticide, acaricide Applicant Bayer CropScience SA-NV Composition 150 g/L spirotetramat Formulation type Oil Dispersion [Code: OD] Packaging Size : 1 to 10 L Material : HDPE or COEX/PA

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 6 of 114

2.2. Classification and labelling

The identity of all substances in the mixture that contribute to the classification of the mixture *: Spirotetramat

Pictogram: GHS07 Signal word: warning GHS08 GHS09 H-statements: H317 May cause an allergic skin r eaction. H319 Causes serious eye irritation. H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. H411 Toxic to aquatic life with long lasting effects. P-statements: P280 Wear protective gloves/protective clothing/eye prot ection/face protection. P308+P311 IF exposed or concerned: Call a POISON CENTER/doctor/… P501 Dispose of contents/container to .... Supplemental Hazard EUH401 To avoid risks to human health and the information: environment, comply with the instruction s for use. SP1 Do not contaminate water with the product or its container Child -resistant fastening obligatory? Not applicable Tactile warning of danger obligatory? Not applicable

Explanation: Pictogram: - H-statements: - P-statements: Applicant’s proposal is accepted. Other: - * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

Other phrases

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2.3. Product uses

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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season Existing Uses 16 Netherla Apple F Rhopalosiphum insertum Foliar BBCH69 - End a)b) 2 a) 0.75 a) 0.1125 1000 - 21 After flowering – No flowers nds MABSD RHOPIN, Dysaphis spraying of flowering (14 d) b) 1.5 b) 0.225 1500 present (C-zone) devecta DYSADE , BBCH81 - According to Ctgb list of crops: Dysaphis plantaginea Beginning of pome fruit = apple, pear, quince, DYSAPL, Aphis pomi ripening medlar, other pomefruit. Max 2 APHIPO. MAY-SEP apl/year for both aphids and eriosoma/psylla 0.05 % v/v 17 Netherla Apple F Eriosoma lanigerum Foliar BBCH69 - End a)b) 2 a) 1 a) 0.15 1000 21 After flowering – No flowers nds MABSD ERISLA spraying of flowering (14 d) b) 2 b) 0.3 present (C-zone) BBCH81 - According to Ctgb list of crops: Beginning of pome fruit = apple, pear, quince, ripening medlar, other pomefruit. Max 2 MAY-SEP apl/year for both aphids and eriosoma/psylla 0.1 % v/v 22 Netherla Pear F Rhopalosiphum insertum Foliar BBCH69 - End a)b) 2 a) 0.75 a) 0.1125 1000 - 21 After flowering – No flowers nds PYUCO RHOPIN, Aphis pomi spraying of flowering (14 d) b) 1.5 b) 0.225 1500 present (C-zone) APHIPO, BBCH81 - According to Ctgb list of crops: Dysaphis pyri DYSAPY Beginning of pome fruit = apple, pear, quince, Anuraphis farfarae ripening medlar, other pomefruit. Max 2 ANURFA, Melanaphis MAY-SEP apl/year for both aphids and pyraria PIRAST. eriosoma/psylla 0.05 % v/v

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 23 Netherla Pear F Psylla pyri PSYLPI Foliar BBCH69 - End a)b) 2 a) 1 a) 0.15 1000 21 After flowering – No flowers nds PYUCO spraying of flowering (14 d) b) 2 b) 0.3 present (C-zone) BBCH81 - According to Ctgb list of crops: Beginning of pome fruit = apple, pear, quince, ripening medlar, other pomefruit. Max 2 MAY-SEP apl/year for both aphids and eriosoma/psylla 0.1 % v/v 35 Netherla Cherry F Myzus cerasi MYZUCE Foliar BBCH69 - End a)b) 2 a) 0.75 a) 0.1125 1000 - 21 After flowering – No flowers nds PRNAV, PRNCE spraying of flowering (14 d) b) 1.5 b) 0.225 1500 present (C-zone) BBCH81 - According to Ctgb list of crops: Beginning of Stone fruit = cherry, plum, apricot, fruit coloring peach, other stone fruit. MAY-SEP 50 Netherla Plum F Brachycaudus prunicola Foliar BBCH69 - End a)b) 2 a) 0.75 a) 0.1125 1000 - 21 After flowering – No flowers nds PRNDO APPEPR, Hyalopterus spraying of flowering (14 d) b) 1.5 b) 0.225 1500 present (C-zone) amygdali HYALAM BBCH81 - According to Ctgb list of crops: Hyalopterus pruni Beginning of Stone fruit = cherry, plum, apricot, HYALPR fruit coloring peach, other stone fruit. MAY-SEP

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 62 Netherla Strawberry F Macrosiphum euphorbiae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 1200 n.a. Not for fruit production nds FRAAN MACSEU , Aulacorthum spraying leaf unfolded (14 d) b) 1 b) 0.15 NL:vermeerderingsvelden en (C-zone) solani AULASO , Myzus BBCH56 - wachtbedden persicae MYZUPE , Inflorescence Aphis Fabae APHIFA elongating Brachycaudus prunicola MAR-NOV APPEPR , Hyperomyzus lactucae HYPELA, Nasonovia ribisnigri NASORN , Amphorophora idaei AMPHID , Chaetosiphon fragaefolii CHTSFR , Aphis gossypii APHIGO , Myzus ascalonicus MYZUAS 63 Netherla Strawberry F Aphis sp. L. APHISP Foliar BBCH71 a)b) 2 a) 0.5 a) 0.075 200 - 1200 n.a. Not for fruit production nds FRAAN spraying BBCH97 - Old (14 d) b) 1 b) 0.15 NL:vermeerderingsvelden en (C-zone) leaves dead wachtbedden MAR-NOV 68 Netherla Berries F Aphis sp. L. APHISP Foliar BBCH91 - Shoot a)b) 2 a) 0.5 a) 0.075 1000 n.a. according to Ctgb: braam en nds VACSS, RIBSS, spraying growth (14 d) b) 1 b) 0.15 framboosachtigen (C-zone) RUBSS completed 0.05 % v/v BBCH92 - Leaves begin to discolor JUL-NOV

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 82 Netherla Onion F Thrips tabaci THRITB Foliar BBCH13 - 3rd a)b) 2 a) 0.5 a) 0.075 150 - 400 7 nds ALLCE spraying leaf (>3 cm) (7 d) b) 1 b) 0.15 (C-zone) visible BBCH47 - Bolting begins; in 10% leaves bent over APR-OCT 182, Netherla Brassica vegetables F Aleyrodes proletella Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 800 3 according to Ctgb: "koolgewassen" 191, nds (BRSOK, BRSOB, ALEUPR, Brevicoryne spraying leaf unfolded (14 d) b) 1 b) 0.15 = flowering-, head-, leafy cabages 199, (C-zone) BRSOK, BRSOR, brassicae BRVCBR BBCH49 - and kohlrabi. 204, BRSOS, BRSOL, Typical size and For Brassica crops max. 2 211, BRSCH, BRSOG) form reached; applications per crop season 220, head tightly 227, closed 240 MAY-NOV 249 Netherla Lettuce F Myzus persicae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 800 7 nds LACSA MYZUPE, Nasonovia spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) ribisnigri NASORN, BBCH49 - Aphis gossypii APHIGO, Typical size, Uroleucon sonchi form and DACTSN firmness of heads reached APR-OCT

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 253 Netherla Endive, broad-leaf F Myzus persicae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 800 7 nds (scarole) MYZUPE, Nasonovia spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) CICEL ribisnigri NASORN, BBCH49 - Aphis gossypii APHIGO, Typical size, Uroleucon sonchi form and DACTSN firmness of heads reached APR-OCT 258 Netherla Spinach family F Myzus persicae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 800 7 Spinach and similar (incl rettich nds SPQOL MYZUPE, Nasonovia spraying leaf unfolded (14 d) b) 1 b) 0.15 and daikon) (C-zone) ribisnigri NASORN, BBCH48 - 80% Aphis gossypii APHIGO, of the leaf mass Uroleucon sonchi reached DACTSN APR-OCT 259 Netherla Spinach family G Myzus persicae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 1000 7 Spinach and similar (incl rettich nds SPQOL I MYZUPE, Nasonovia spraying leaf unfolded (14 d) b) 1 b) 0.15 and daikon) (C-zone) ribisnigri NASORN, BBCH48 - 80% Aphis gossypii APHIGO, of the leaf mass Uroleucon sonchi reached DACTSN JAN-DEC 263 Netherla Chicory, witloof F Myzus persicae MYZUPE Foliar BBCH13 - 3rd a)b) 2 a) 0.5 a) 0.075 200 - 800 70 nds CICIF spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) BBCH49 - Expansion complete; typical form and size reached MAY-SEP

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 267 Netherla Bean, fresh F Aphis sp. L. APHISP Foliar BBCH71 - 10% a)b) 2 a) 0.5 a) 0.075 200 - 800 7 With pods nds PHSSS spraying of pods have (14 d) b) 1 b) 0.15 (C-zone) reached typical length BBCH79 - Pods: individual beans easily visible MAY-OCT 279 Netherla Pea, fresh F Aphis sp. L. APHISP Foliar BBCH71 - 10% a)b) 2 a) 0.5 a) 0.075 200 - 800 7 With pods nds PIBSS spraying of pods have (14 d) b) 1 b) 0.15 (C-zone) reached typical length BBCH79 - Pods have reached typical size MAY-OCT 288 Netherla Flower bulb and F Macrosiphum euphorbiae Foliar BBCH69 - End a)b) 3 2 a) 0.5 a) 0.075 150 - 400 n.a. After flowering – No flowers nds flower tuber crops MACSEU, Aulacorthum spraying of flowering (14 d) b) 1.5 1.0 b) 0.225 0.15 present (C-zone) solani AULASO, Myzus BBCH89 - Full According to Ctgb: "bloembol en persicae MYZUPE, Aphis maturity: seeds bloemknolgewassen" Fabae APHIFA, Aphis black and hard gossypii APHIGO, APR-NOV Dysaphis anthrisci DYSAAN 289 Netherla Perennial crops F Macrosiphum euphorbiae Foliar BBCH69 - End a)b) 2 a) 0.5 a) 0.075 1000 n.a. After flowering – No flowers nds MACSEU, Aulacorthum spraying of flowering (14 d) b) 1 b) 0.15 present (C-zone) solani AULASO, Myzus BBCH89 persicae MYZUPE, Aphis JAN-DEC Fabae APHIFA, Aphis gossypii APHIGO, Rhodobium porosum METOPO

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 291 Netherla Tree nursery crops F Macrosiphum euphorbiae Foliar BBCH69 - End a)b) 2 a) 0.6 a) 0.09 1000 - n.a. After flowering – No flowers nds MACSEU, Aulacorthum spraying of flowering (14 d) b) 1.2 b) 0.18 1200 present (C-zone) solani AULASO, Myzus BBCH89 persicae MYZUPE, Aphis APR-SEP Fabae APHIFA, Aphis gossypii APHIGO, , Phyllaphis fagi PHYAFA, Staticobium limonii New Uses 64 Netherla Strawberry F Macrosiphum euphorbiae Foliar BBCH49 - a)b) 2 a) 0.5 a) 0.075 200 - 1200 n.a. No application possible less than nds FRAAN MACSEU , Aulacorthum spraying Several daughter (14 d) b) 1 b) 0.15 14 days before flowering, during (C-zone) solani AULASO, Myzus plants with roots flowering and until last harvest. persicae MYZUPE, Aphis BBCH56 - Fabae APHIFA Inflorescence Brachycaudus prunicola elongating APPEPR, Hyperomyzus lactucae HYPELA, Nasonovia ribisnigri NASORN, Amphorophora idaei AMPHID, Chaetosiphon fragaefolii CHTSFR, Aphis gossypii APHIGO, Myzus ascalonicus MYZUAS 65 Netherla Strawberry F Aphis sp. L. APHISP Foliar BBCH93 - Old a)b) 2 a) 0.5 a) 0.075 200 - 1200 n.a. Post harvest nds FRAAN spraying leaves dying, (14 d) b) 1 b) 0.15 (C-zone) young leaves curling BBCH97 - Old leaves dead

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 69 Netherla Currant, red, white, F Hyperomyzus lactucae Foliar BBCH71 - a)b) 2 a) 0.5 a) 0.075 200 - 1200 14 After flowering – No flowers nds black HYPELA. spraying Beginning of (14 d) b) 1 b) 0.15 present (C-zone) RIBSS fruit growth: first fruits visible at raceme base BBCH85 - Advanced ripening 74 Netherla Potato F MYZUPE (Myzus Foliar BBCH69 - End a)b) 4 2 a) 0.5 a) 0.075 150 - 400 14 After flowering – No flowers nds SOLTU persicae) APHINA (Aphis spraying of flowering (7 d) b) 2.00 1.0 b) 0.30 0.15 present (C-zone) nasturtii) BBCH95 176 Netherla Brassica vegetables F Contarinia nasturtii Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 800 3 Broccoli BRSOK b nds BRSSS CONTNA spraying leaf unfolded (14 d) b) 1 b) 0.15 Brussels sprouts BRSOK (C-zone) Thrips THRITB BBCH49 - Cabbage, Chinese BRSCH Typical size and Cabbage, Savoy BRSOS form reached; Cabbage, red BRSOR head tightly Cabbage, white BRSOL closed Cauliflower BRSOB MAY-NOV Kohlrabi BRSOG For Brassica crops max. 2 applications per crop season 82 Netherla Shallots (ALLAS), F Thrips tabaci THRITB Foliar BBCH13 - 3rd a)b) 2 a) 0.5 a) 0.075 150 - 400 7 Covered by onion nds Garlic (ALLSA) spraying leaf (>3 cm) (7 d) b) 1 b) 0.15 (C-zone) visible BBCH47 - Bolting begins; in 10% leaves bent over APR-OCT Existing minor uses

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25 Netherla Quince F Eriosoma lanigerum Foliar BBCH69 - End a)b) 2 a) 1 a) 0.15 1000 21 After flowering – No flowers nds CYDOB ERISLA spraying of flowering (14 d) b) 2 b) 0.3 present (C-zone) Psylla pyri PSYLPI BBCH81 - According to Ctgb list of crops: Beginning of pome fruit = apple, pear, quince, ripening medlar, other pomefruit. Max 2 MAY-SEP apl/year for both aphids and eriosoma/psylla 0.1 % v/v

26 Netherla Medlar F Rhopalosiphum insertum Foliar BBCH69 - End a)b) 2 a) 0.75 a) 0.1125 1000 - 21 After flowering – No flowers nds MSPGE RHOPIN, Dysaphis spraying of flowering (14 d) b) 1.5 b) 0.225 1500 present (C-zone) devecta DYSADE, BBCH81 - According to Ctgb list of crops: Dysaphis plantaginea Beginning of pome fruit = apple, pear, quince, DYSAPL, Aphis pomi ripening medlar, other pomefruit. Max 2 APHIPO, Eriosoma MAY-SEP apl/year for both aphids and lanigerum ERISLA, eriosoma/psylla Dysaphis pyri DYSAPY, 0.05 % v/v Anuraphis farfarae ANURFA

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55 Netherla Grape F Myzus persicae Foliar BBCH69 - End a)b) 2 a) 0.6 a) 0.09 1200 14 After flowering – No flowers nds VITVI MYZUPE spraying of flowering (14 d) b) 1.2 b) 0.18 present (C-zone) BBCH81 - 0.05 % v/v Beginning of ripening JUL-SEP 68 Netherla Blackberry and F Brachycaudus prunicola Foliar BBCH91 - Shoot a)b) 2 a) 0.5 a) 0.075 1000 n.a. according to Ctgb: bessen, braam nds raspberry family APPEPR, Hyperomyzus spraying growth (14 d) b) 1 b) 0.15 en framboosachtigen, only post (C-zone) (Rubus spp.) lactucae HYPELA, completed harvest VACSS, RIBSS, Amphorophora idaei BBCH92 - 0.05 % v/v AMPHID, Sitobion RUBSS Leaves begin to fragariae MACSFR, discolor Amphorophora rubi JUL-NOV AMPHRU, Aphis idaei APHIID, Rhopalosiphoninus ribesinus RHOSRI

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 241 Netherla Lamb's Lettuce F Myzus persicae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 800 7 nds VLLLO MYZUPE, Nasonovia spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) ribisnigri NASORN, BBCH48 - 80% Aphis gossypii APHIGO, of the leaf mass Uroleucon sonchi reached DACTSN APR-OCT 253 Netherla Endive, broad-leaf F Pemphigus bursarius Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 800 7 nds (scarole) PEMPBU spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) CICEL BBCH49 - Typical size, form and firmness of heads reached APR-OCT 254 Netherla Rucola / Rocket F Myzus persicae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 800 7 nds ERUVE MYZUPE, Nasonovia spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) ribisnigri NASORN, BBCH48 - 80% Aphis gossypii APHIGO, of the leaf mass Uroleucon sonchi reached DACTSN APR-OCT 263 Netherla Chicory, witloof F Pemphigus bursarius Foliar BBCH13 - 3rd a)b) 2 a) 0.5 a) 0.075 200 - 800 70 nds CICIF PEMPBU spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) BBCH49 - Expansion complete; typical form and size reached MAY-SEP

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 264 Netherla Herbs (aromatic and F Myzus persicae Foliar BBCH12 - 2nd a)b) 2 a) 0.5 a) 0.075 200 - 800 7 nds medical) excluding MYZUPE, Uroleucon spraying leaf unfolded (14 d) b) 1 b) 0.15 (C-zone) camomile sonchi DACTSN BBCH48 - 80% of the leaf mass reached APR-OCT 283 Netherla Fibre Crops F Macrosiphum euphorbiae Foliar BBCH69-89 a)b) 2 a) 0.5 a) 0.075 200 - 800 n.a. Covers Hemp, Flax and Nettle nds MACSEU, Aulacorthum spraying APR-OCT (14 d) b) 1 b) 0.15 After flowering – No flowers (C-zone) solani AULASO , Myzus present persicae MYZUPE, Aphis Fabae APHIFA, Hyperomyzus lactucae HYPELA, Aphis gossypii APHIGO, Dysaphis anthrisci DYSAAN, Rhodobium porosum METOPO, Pemphigus bursarius PEMPBU 284 Netherla Chrysantenum G Macrosiphum euphorbiae Foliar BBCH12-48 a)b) 3 2 a) 0.5 a) 0.075 200 - 800 n.a. nds CHYHO I MACSEU, Aulacorthum spraying JAN-DEC (14 d) b) 1.5 1.0 b) 0.225 0.15 (C-zone) solani AULASO, Myzus persicae MYZUPE, Aphis Fabae APHIFA Aphis gossypii APHIGO, Rhodobium porosum METOPO, Tetranychus urticae TETRUR, Frankliniella occidentalis FRANOC

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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 controlled (days G Method / Timing / Growth Max. number L product / ha kg as/ha Water ) e.g. g safener/synergist per ha (crop destination / (additionally: Kind stage of crop & (min. interval a) max. rate L/ha purpose of crop) o developmental stages of season between per appl. a) max. rate applications) min / max r the pest or pest group) b) max. total per appl. a) per use rate per b) max. total I b) per crop/ crop/season rate per (mCH = Meter of Canopy Height) season crop/season 290 Netherla Plant breeding crops F Macrosiphum euphorbiae Foliar BBCH69 - End a)b) 2 a) 0.5 a) 0.075 200 - 800 n.a. After flowering – No flowers nds and seeds production MACSEU, Myzus spraying of flowering (14 d) b) 1 b) 0.15 present (C-zone) persicae MYZUPE, Aphis BBCH91 Fabae APHIFA, APR-OCT Brachycaudus prunicola APPEPR, Hyperomyzus lactucae HYPELA, Aphis gossypii APHIGO, Dysaphis anthrisci DYSAAN, Rhodobium porosum METOPO New Minor Uses 32 Netherla Apricot F Myzus cerasi MYZUCE, Foliar BBCH69 - End a)b) 2 a) 0.75 a) 0.1125 1000 - 21 After flowering – No flowers nds PRNAR Brachycaudus prunicola spraying of flowering (14 d) b) 1.5 b) 0.225 1500 present (C-zone) APPEPR, Hyalopterus BBCH81 - According to Ctgb list of crops: amygdali HYALAM, Beginning of Stone fruit = cherry, plum, apricot, Hyalopterus pruni fruit coloring peach, other stone fruit. HYALPR MAY-SEP

40 Netherla Peach F Myzus cerasi MYZUCE, Foliar BBCH69 - End a)b) 2 a) 0.75 a) 0.1125 1000 - 21 After flowering – No flowers nds PRNPS Brachycaudus prunicola spraying of flowering (14 d) b) 1.5 b) 0.225 1500 present (C-zone) APPEPR, Hyalopterus BBCH81 - According to Ctgb list of crops: amygdali HYALAM, Beginning of Stone fruit = cherry, plum, apricot, Hyalopterus pruni fruit coloring peach, other stone fruit. HYALPR MAY-SEP

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285 Netherla Floriculture crops F Macrosiphum euphorbiae Foliar BBCH69 - End a)b) 3 2 a) 0.5 a) 0.075 1000 n.a. After flowering – No flowers nds MACSEU, Aulacorthum spraying of flowering (14 d) b) 1.5 0.1 b) 0.225 0.15 present (C-zone) solani AULASO, Myzus BBCH89 persicae MYZUPE, Aphis JAN-DEC Fabae APHIFA Aphis gossypii APHIGO, Rhodobium porosum METOPO, 69 Netherla Currant F Hyperomyzus lactucae Foliar BBCH71 - a)b) 2 a) 0.5 a) 0.075 200 - 1200 14 After flowering – No flowers nds RIBSSB HYPELA. spraying Beginning of (14 d) b) 1 b) 0.15 present (C-zone) fruit growth: first fruits visible at raceme base BBCH85 - Advanced ripening

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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)

Overall Summary: MOVENTO is an oil-based suspension concentrate, containing 150 g/L spirotetramat. Its appearance is that of a beige suspension with a musty odour. It has no oxidizing properties. It has a flash point higher than 100 °C and has an auto ignition temperature of 405 °C. The preparation should be regarded as being a surface active material. The pH of 1% aqueous dilution is 4.2 and it is within the range that naturally occurs e.g. in soil. Its stability allows storage under practical and commercial conditions. Its technical properties indicate that no particular problems have to be expected, when it is used as recommended.

The technical characteristics of the product are acceptable for an oil-based suspension concentrate.

Implications for labelling: No classification is required. Based on the results of the stability studies, the following implications for labelling are stated: - “Shake well before use” for small containers (up to 3L) - “Large containers must be opened and stirred adequately before use” for large containers (3 – 10 L).

Compliance with FAO guidelines: The product MOVENTO complies with FAO specifications, as far as could be assessed.

Compatibility of mixtures: Tank mixtures with other pesticides are not recommended on the product label for MOVENTO.

Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.

Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of MOVENTO has been provided and is considered to be acceptable.

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) Analytical methods for determination of spirotetramat, impurities and relevance of CIPAC methods in MOVENTO were not evaluated as part of the EU review of spirotetramat. Therefore all relevant data are provided and are considered adequate.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) All analytical methods are active substance data and were provided in the EU review of spirotetramat and were considered adequate.

Additional data on methods/validation for spirotetramat have been developed and provided. All data are considered adequate.

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The analytical methods for the determination of residues of spirotetramat in surface water are compliant with Dutch national guidance (LOQ < 0.1 µg/kg).

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

Endpoints relevant for risk assessment

Dermal absorption: Dermal absorption studies were performed with the OD 150 formulation in vitro using human skin and in vivo in the rat. The in vitro human skin data are used to establish the dermal absorption values which are used in the risk assessment: 0.5% for the concentrate and 5% - 7% for spray dilutions.

AOEL: Considering the proposed use pattern it is appropriate to compare predicted exposures to an AOEL derived from sub-chronic dosing studies. An Acceptable Operator Exposure Level (AOEL) of 0.05 mg/kg bw/day is established for spirotetramat based on the NOAEL of 5 mg/kg bw/day obtained in the 1-year oral toxicity in the dog and using a safety factor of 100.

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) Acute toxicity studies for MOVENTO (Specification No. 102000016434) were not evaluated as part of the EU review of the spirotetramat. Therefore, all relevant data were provided and are considered adequate.

MOVENTO is non-toxic after acute oral, dermal and inhalative administration. The formulation is slightly irritating to the skin and eyes of rabbits, however the scores do not require classification for skin irritation according to Regulation (EC) No 1272/2008. A skin sensitisation study has not been performed for animal welfare reasons and due to clear skin sensitising effects observed with a similar formulation (MOVENTO; Specification No. 102000011380) in a Buehler Patch test. Thus, classification as a skin sensitizer is proposed for this formulation.

The following classification/labelling is triggered: - Regulation (EC) No 1272/2008 (CLP): Eye irritation Cat. 2; H319 (causes serious eye irritation) Skin sensitisation Cat. 1; H317 (may cause an allergic skin reaction)

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) Operator exposure to MOVENTO (Specification No. 102000016434) was not evaluated as part of the EU review of spirotetramat. Therefore all relevant data and risk assessments have been provided and are considered to be adequate.

A core assessment for the product is not fully applicable for The Netherlands. A National Addendum considering national specific requirements is presented.

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Summary of critical GAP Application Representative Max Max Minimum Number of Model equipment Crop(s) Application Application Spray applications rate rate dilution (L (kg a.s./ha) (L/ha) product/ha) Dutch approach: Mechanical upward: EUROPOEM I Spraying, field, Manual upward: Apple, pear, mechanical 1 0.150 1000 2 M/L liquid: quince, medlar † and manual EUROPOEM I upward (dermal), Dutch Model (respiratory), Appl.: German model 90 th perc. Dutch approach: Spraying, Mechanical field, Grape, tree 0.6 0.09 1000 2 downward: mechanical nursery EUROPOEM I downward

Dutch approach: Manual downward: Spraying, M/L EUROPOEM field, manual Strawberry* 0.5 0.075 200 2 I (dermal), Dutch downward Model (respiratory), Appl.: UK-POEM Dutch approach: Spraying, Chrysantemum $ 0.5 0.075 200 3 Dutch greenhouse greenhouse model † covers apricot, cherry,peach, nectarine, plum, grape, berries, currant, tree nursery $ covers spinach * covers strawberries, currant, perennial crops, fibre crops, herbs and floricultural crops

• Conclusions

Outdoor uses : Exposure estimates predict acceptable risks for all intended uses. Mechanical and manual upward and downward spraying does not require the use of PPE. Overall, it is concluded that the use of MOVENTO does not result in an unacceptable risk for operators.

Indoor uses : Exposure estimates predict acceptable risks for all intended uses even without PPE. An unacceptable risk of operators during application in the greenhouse is therefore not anticipated.

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) Bystander exposure to MOVENTO was not evaluated as part of the EU review of spirotetramat. Therefore, all relevant data and risk assessments have been provided and are considered adequate.

Outdoor uses: A core assessment for the product is not fully applicable for The Netherlands. A National Addendum considering national specific requirements for outdoor uses is presented.

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Bystander exposure is calculated with the EUROPOEM II model. In addition, for residents and bystanders calculations were made using the UK method. In the core assessment calculations using the German model were made for bystanders/residents positioned at a distance of 3 m (fruit crops, airblast spraying) and 1 m (field crops, boom spraying) to the application equipment.

Indoor uses: the Lee side turbulence model estimates the acute exposure of persons outside a greenhouse. It was concluded that the use of MOVENTO according to the intended uses is safe for residents nearby greenhouses.

Conclusion Bystander and resident exposure estimates predict acceptable risks for the critical GAP.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) Worker exposure to MOVENTO was not evaluated as part of the EU review of spirotetramat. Therefore, all relevant data and risk assessments have been provided and are considered adequate.

A core assessment for the product is not fully applicable for The Netherlands. A National Addendum considering national specific requirements is presented.

Outdoor and indoor uses: The determination of the cGAP for worker re-entry is based on the recommendation provided in the EUROPOEM II report 1 for worker exposure for four different harvesting scenarios with bare hands. • Conclusions

Exposure of workers entering treated areas is within acceptable levels. Calculations reflect standard work clothing worn by adult workers (shoes, socks, long-legged pants, and long sleeves) working with bare hands. Workers do not wear protective equipment. Under these conditions exposure during re-entry is within acceptable levels. It is concluded that an unacceptable risk for re-entry is not anticipated.

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) EFSA assessed the active substance spirotetramat and proposed the following residue definitions (EFSA Journal 2013;11(6):3243): - Monitoring : sum of spirotetramat and spirotetramat-enol, expressed as spirotetramat ; - Risk assessment : sum of spirotetramat, spirotetramat-enol, spirotetramat-enol-Glc, spirotetramat-ketohydroxy and spirotetramat-monohydroxy, expressed as spirotetramat.

MRLs based on the residue definition for monitoring are established in the Annexes of Regulation (EC) 396/2005 and were amended recently by Implmenting Regulation (EU) 2017/1016.

Pome fruits Outdoor: 2x 0.15 kg as/ha, interval 14 days, PHI= 21 days, BBCH 69-81 In total 25 trials (13 NEU & 12 SEU) are available for spirotetramat in pome fruit (DAR; 2008) & (EFSA Journal 2013, 11(6):3243). The trials were conducted with more critical GAP (2x 216 g/ha; PHI: 21 d) as compared to the intended cGAP. An MRL of 0.4 mg/kg is calculated for spirotetramat in apples and pears based on the data from NEU(0.064, 0.064, 0.064, 0.069, 0.094, 0.094, 0.098, 0.099, 0.114,

1 EUROPOEM II project FAIR3-CT96-1406; Post Application Exposure of Workers to Pesticides in Agriculture, Report of the Re-entry Working Group; December 2002

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0.115, 0.155, 0.156, 0.254 mg/kg). Thirteen residue trials from the NEU are sufficient to support the intended use of Spirotetramat in apples/pears. The residues of spirotetramat will be below the current EU t-MRL (1.0 mg/kg for pomefruit) when the product is applied according to the proposed cGAP.

Cherry (minor crop in NEU) Outdoor: 2x 0.1125 kg as/ha, interval 14 days, PHI = 21 days. Reference is made to twelve valid residue trials ( eight NEU & four SEU) evaluated in the DAR and later by EFSA (EFSA journal 2013, 11(6):3243). Trials were conducted with more critical cGAP(2x 216 g/ha ;PHI: 21 d) as compared to the intended cGAP. An MRL of 2.0 mg/kg is calculated for spirotetramat in cherries based on seven residue data from NEU (0.248, 0.285, 0.295, 0.417, 0.583, 0.826, 0.939 mg/kg). As cherry is minor crop in NEU seven residue trials are sufficient to support the intended use of Spirotetramat. The residues of spirotetramat will be below the current EU t-MRL (3.0 mg/kg for stone fruit) when the product is applied according to the proposed GAP.

Peach/Nectarine/Apricot (minor crop in NEU) Outdoor: 2x 0.1125 kg as/ha, interval 14 days, PHI = 21 days. Reference is made to fourteen valid residue trials ( five NEU & nine SEU) evaluated in the DAR and later by EFSA (EFSA journal 2013, 11(6):3243). Trials were conducted with more critical cGAP(2x 216 g/ha ;PHI: 21 d) as compared to the intended cGAP. An MRL of 1.5 mg/kg is calculated for spirotetramat in peach/nectarine/apricot on the basis of data from the NEU (0.314, 0.438, 0.511, 0.520, 0.696 mg/kg). Five residue trials are sufficient to support the intended use of Spirotetramat in Peach/Nectarine/Apricot. The residues of spirotetramat will be below the current EU t-MRL (3.0 mg/kg for stone fruit) when the product is applied according to the proposed GAP.

Plum (minor crop in NEU) Outdoor: 2x 0.1125 kg as/ha, interval 14 days, PHI = 21 days. Eight acceptable trials from the NEU are available in the DAR to support the intended use of spirotetramat in plum. Four additional trials were also evaluated in the DAR from SEU. Trials were conducted with more critical cGAP (2x 216 g/ha ;PHI: 21 d) as compared to the intended cGAP. Based on the current residue definition for monitoring an MRL of 1.5 mg/kg is calculated for spirotetramat in plum based on the dataset from NEU (0.119 , 0.145 , 0.193 , 0.353 , 0.416 , 0.511 , 0.582 , 0.828 mg/kg). The residues of spirotetramat will be below the current EU t-MRL (3.0 mg/kg for stone fruit) when the product is applied according to the proposed GAP.

Grape Outdoor: 2x 0.09 kg as/ha, interval 14 days, PHI= 14 days. To support the intended use, eight valid residue trials are available in grapes from the NEU that are already evaluated by EFSA (EFSA Journal 2013;11(6)3243). The trials were conducted according to the intended cGAP (±25%); cGAP-NEU: ( 2x72 g/ha; PHI:21d). In addition to the NEU data, ten residue trials were also evaluated from the SEU. Based on the current residue definition for monitoring an MRL of 0.7 mg/kg is calculated for spirotetramat in grapes based on residue levels from NEU trials (0.142, 0.135, 0.189, 0.2, 0.242, 0.22, 0.284, 0.26 mg/kg). The residues of spirotetramat will be below the current EU t-MRL (2.0 mg/kg for grapes) when the product is applied according to the proposed GAP.

Strawberry Outdoor: 2x 0.075 kg as/ha, BBCH 49-56, after BBCH 97 (post-harvest), interval 14 day, PHI=n.a In total eight valid residue trials are available from the NEU to support the intended pre flowering use of spirotetramat in strawberries. These trials have already been evaluated by zRMS Austria. Trials were conducted with more critical GAP (2x 100 g/ha) as compared to the intended use. Based on the current residue definition for monitoring an MRL of 0.3 mg/kg is calculated for spirotetramat in strawberries based on residue levels from NEU trials (<0.05; <0.05; <0.05; <0.05; <0.05; <0.05; 0.077; 0.20 mg/kg). Results from these trials show that residues from the NEU outdoor uses are covered by the existing EU MRL of 0.4 mg/kg for spirotetramat in strawberries .

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Currants Outdoor: 2 x 0.075 kg as/ha, after flowering , PHI = 14 days. In the Netherlands, only the use in currants is requested. Four newly submitted residue trials are available in the Registration Report prepared by the zRMS. Based on these trials, an MRL exceedance is expected for spirotetramat in currants. Accordingly, zRMS Austria concluded not to grant authorisation of the proposed use the existing EU MRL is raised. In accordance with the decision of zRMS, for this registration authorization cannot be granted in currants unless the EU MRL is raised.

Berries: Other small fruits and berries Outdoor :2x 0.075 kg as/ha, BBCH91-92, interval 14 days, PHI = n.a. A post-harvest use is proposed in the blackberry and raspberry family. As the plant protection product will be applied to the stalks after the edible parts have been harvested, an authorisation can be granted.

Potatoes Outdoor: 4x 0.072 kg as/ha, interval 7 days, PHI= 14 days In total eight trials are available in the RR by zRMS Austria from the NEU supporting the intended use of spirotetramat in potatoes (cGAP: 4 x 0.75 kg a.s./ha, PHI 14 d). Based on the trials an MRL of 0.4 mg/kg is calculated for spirotetramat in potatoes using dataset from NEU (0.056, 0.088, 0.089, 0.092, 0.10, 0.12, 0.16, 0.21 mg/kg). The residues of spirotetramat will be below the current EU t-MRL (0.8 mg/kg for potatoes) when the product is applied according to the proposed GAP.

Onion, shallots Outdoor: 2x 0.075 kg as/ha, interval 7 days, PHI = 7 days. Eight acceptable trials are available in the DAR for onions from the NEU (cGAP: 4x 0.72 kg a.s./ha, PHI 7d) . These trials have been already evaluated during the peer review of the pesticide risk assessment of spirotetramat. An MRL of 0.4 mg/kg is calculated for spirotetramat in onions using a dataset from the NEU (0.054, 0.084, 0.092, 0.097, 0.113, 0.109, 0.162, 0.202 mg/kg). The current EU MRL of 0.4 mg/kg for spirotetramat in onions will not be exceeded when the product is used according to the intended recommendations. According to the EU Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs, residues in bulb onion can be extrapolated to shallot.

Brassica vegetables Outdoor: 2x 0.075 kg as/ha, interval 14 days, PHI 3 days.

Flowering brassica For flowering brassica nine trials with spirotetramat in cauliflower and broccoli are available from the NEU in the DAR (cGAP: 2x 72 g/ha PHI, 3 d). The trials are considered valid to support the current registration of spirotetramat in flowering brassica. On the basis of the OECD calculator, an MRL of 1.5 mg/kg is calculated for spirotetramat in flowering brassica using a dataset from the NEU (0.11, 0.22, 0.241, 0.308, 0.369, 0.384, 0.427, 0.521, 0.578 mg/kg). Based on an EU calculator and the same residue dataset the current EU MRL is set at 1 mg/kg for spirotetramat in flowering brassica. Hence, since the difference is caused by the method of calculation, it can be considered that the current MRL will not be exceeded when the product is used according to the intended recommendations (as agreed during the Standing Committee on Pesticides Residues, 2012).

Brussels sprouts Eight trials are available in the DAR (cGAP: 2x 72 g/ha PHI, 3 d) with spirotetramat from the NEU. The trials are considered valid to support the current registration of spirotetramat in Brussels sprouts . On the basis of the OECD calculator, an MRL of 0.4 mg/kg is calculated for spirotetramat in Brussels sprouts using a dataset from the NEU (0.088, 2 x 0.089, 0.106, 0.11, 0.128, 0.131, 0.218 mg/kg). Based on these residue dataset and using the EU calculator an MRL of 0.3 mg/kg is set for spirotetramat in Brussels sprouts. Hence, since the difference is caused by the method of calculation it can concluded that

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 27 of 114 the current MRL will not be exceeded when the product is used according to the intended recommendations (as agreed during the Standing Committee on Pesticides Residues, 2012).

Head brassicas (Cabbage- white, red, Savoy) In total ten valid trials in head cabbage are available in the DAR (cGAP: 2x 72 g/ha PHI, 3 d) from the NEU. The trials are considered valid to support the current registration of spirotetramat in head brassicas group. An MRL of 0.4 mg/kg is calculated for spirotetramat in head brassicas a dataset from the NEU (0.091, 0.067, 0.092, 0.077, 0.097, 0.151, 0.104, 0.186, 0.134, 0.261 mg/kg). The residue data are well covered by the existing EU MRL of 2.0 mg/kg.

Leafy brassicas (Chinese cabbage, Kale) Four acceptable trials with curly kale are available in the DAR (cGAP: 2x 72 g/ha PHI, 3 d) from the NEU. The trials are considered valid to support the current registration of spirotetramat in kale and Chinese cabbage. An MRL of 1.5 is calculated for kales using the NEU dataset (0.24, 0.301, 0.62, 0.765 mg/kg). The residue data are well covered by the existing EU MRL of 7.0 mg/kg for kales and Chinese cabbage.

Kohlrabi Four valid trials from the NEU are available in the DAR (cGAP: 3 x 72 g/ha PHI, 3 d). The trials in kohlrabi are considered acceptable and sufficient to support the intended uses of spirotetramat in kohlrabi. On the basis of these data, an MRL of 1.5 is calculated using the NEU dataset (0.152, 0.232, 0.554, 0.67 mg/kg). Hence, the residue data are well covered by the existing EU MRL of 2.0 mg/kg for spirotetramat in kohlrabi.

Lettuce and other salad plants Outdoor: 2x 0.075 kg as/ha, interval 14 days, PHI = 7 days. For this application, in total ten trials (eight open leaf variety and two head variety) are available in lettuce from the NEU. Four of the trials were already evaluated in the DAR and later by EFSA (EFSA Journal 2012, 11(6):3243) and six trials were evaluated in the RR by zRMS Austria. The trials are considered acceptable to support the intended use of spirotetramat in lettuce. On the basis of the trials an MRL of 0.7 mg/kg is calculated for spirotetramat in lettuce (0.117, 0.13, 0.13, 0.151, 0.19, 0.20, 0.25, 0.27, 0.341, 0.441 mg/kg). The residue data are well covered by the existing EU MRL of 7 mg/kg. According to SANCO 7525/VI/95 Rev. 10.2 residues from eight trials in lettuce open leaf variety can be extrapolated to the whole subgroup lettuce and salad plants.

Spinach & similar (leaves) Indoor & outdoor: 2x 0.075 kg as/ha, interval 14 days, PHI = 7 days According to the guidance document SANCO 7525/VI/95 - Rev. 10.2 results of residue eight trials in lettuce (min. four trials with open leaf variety) can be extrapolated to spinach. In total ten valid trials in lettuce are available for outdoor use. In addition, eight greenhouse residue trials in lettuce (four head and four leafy) were assessed in the DAR. These trials were conducted with OD 150 formulation at an application rate of 2 x 72 g as/ha and a spray interval of 14d. Residue trials (outdoor and indoor) in lettuce are considered valid to support the intended uses of spirotetramat in the spinach and similar (leaves) group. Residues of spirotetramat in spinach are sufficiently covered by the existing EU MRL of 7 mg/kg.

Witloof (chicory witloof) Outdoor: 2x 0.075 kg as/ha, interval 14 days, PHI = 7 days. To support the use of spirotetramat In NEU four new trials were evaluated in RR by zRMS Austria. In accordance with the conclusion of zRMS, the trials are considered valid to support the intended use in witloof. Residues of spirotetramat in witloof (<0.05; <0.05; <0.055; <0.055 mg/kg) are sufficiently covered by the existing EU MRL of 0.1* mg/kg.

Herbs (medicinal and aromatic) Outdoor: 2x 0.075 kg as/ha, interval 14 days, PHI = 7 days.

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According to the guidance document SANCO 7525/VI/95 - Rev. 10.2 lettuce trials (eight trials in open leaf varieties) can be extrapolated to support uses in whole subgroup herbs and edible flowers. To support the use of spirotetramat in herbs, zRMS Austria uses EU trials on lettuce (outdoor and indoor ). However, to support the intended outdoor use within this registration, CMS refers to the eight field lettuce trials (open leaf variety) form the NEU that were evaluated in the DAR (2 trials) and RR (six trials) (2 x 0.13, 0.15, 0.19, 0.20, 0.25, 0.27, 0.34). On the basis of the residue levels in these trials it can be concluded that existing EU MRL of 4.0 mg/kg will not be exceeded if spirotetramat is applied in/on herbs according to the intended GAP.

Beans and peas (with pods), outdoor Outdoor: 2x 0.075 kg as/ha, interval 14 days, PHI 7 days. In total eight supervised residue trials were conducted in French climbing beans in the greenhouse. These trials were evaluated in the (DAR; 2008) and by EFSA (EFSA Journal 2013;11(6)3243). Furthermore, to support the use of spirotetramat in beans in the field in NEU, 4 residue trials were conducted. The residues in green beans from the four residue trials conducted according to the NEU GAP (2x 75 g as/ha, PHI 7 d) is: 0.08, 0.09, 0.08, 0.08 mg/kg. Fresh legume vegetables (beans and peas with pods) are major crops, and where residue levels >LOQ are found in the trials, eight residue trials are necessary to support the intended field use of spirotetramat in these crops in the NEU. According to zRMS; “ Although it might be considered that the greenhouse trials present a worst case scenario, and results could be further seen by proportionality, the parameters in these two GAPs are much too different. Hence, dataset is not sufficient for authorization of the proposed use; further 4 trials are required ”. In accordance with the conclusion of zRMS, four field residue trials are still required to grant the proposed use of spirotetramat in beans and peas (with pods) according to the intended cGAP. Because no additional trials are available, these uses are withdrawn from the GAP/WG by the applicant.

Fibre Crops Outdoor: 2x 0.075 kg as/ha, interval 14 days, PHI 70 days. Linseeds (flax) and hemp seeds are categorized within the fibre crops (DTG list version 2.1). The current EU MRLs for both crops is set at the LOQ of 0.1 mg/kg. Since no data are available to evaluate the proposed uses of spirotetramat specifically in linseeds and hem seeds, authorization according to the intended cGAP cannot be supported. Since linseed and hem seeds are minor crops in the NEU, four residue trials are required to support the proposed uses in fibre crops (linseeds and hempseeds). For the fibre crops, we include a restriction for consumption by humans and livestock alike.

Behandelde vezelgewassen en producten hiervan niet voor menselijke en/of dierlijke consumptie bestemmen.

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) In order to evaluate the potential chronic exposure to spirotetramat residues through the diet, the Theoretical Maximum Dietary Intakes (TMDI) were estimated using the EFSA PRIMo model (revision 2). For the evaluation of the chronic exposure the model uses 5 WHO diets relevant to the EU and 22 national diets from 13 different EU Member States.

The consumer intake calculations is performed not only considering the crops under evaluation which have registered uses in Europe, but all crops for which import tolerance MRLs were set within the EU. For the crops that are not included in this evaluation the EU MRL (established MRLs acc. Regulation (EC) 364/2014) is used. For the European target crops, which are evaluated in this dossier the STMR is used for the dietary risk assessment. The TMDI for the most vulnerable consumer group did not exceed 27.8 % of the ADI. Hence consumption of spirotetramat residues with food is not expected to impose a chronic risk to the consumer.

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In order to evaluate the potential acute exposure to spirotetramat residues through the diet, the National Estimated Short Term Intakes (NESTI)/International Estimated Short Term Intakes (IESTI) were estimated using the EFSA PRIMo model (revision 2). For the evaluation of the acute exposure 19 national diets from 11 different EU Member States are used. The results for the uses supported with this dossier show that the acute exposure to spirotetramat residues through diet does not exceed 48.1% of the ARfD for children and 19.6% of the ARfD for adults. Hence consumption of spirotetramat residues is not expected to impose an acute risk to consumer.

Based on the different calculations made to estimate the risk for consumer though diet and other means it can be concluded that the use of product MOVENTO does not lead to unacceptable risk for consumer when applied according to the recommendations.

Overall conclusion: On the basis of the residue levels in the trials evaluated for the crops under consideration, it can be concluded that existing EU MRLs will not be exceeded in pome fruits, peach/nectarine/apricot, plum, grape, strawberry, potatoes, onion, shallots, flowering brassica, Brussels sprouts, head brassicas (cabbage- white, red, savoy), leafy brassicas (Chinese cabbage, Kale), kohlrabi, lettuce and other salad plants, spinach & similar (leaves), witloof (chicory witloof) and herbs (medicinal and aromatic) if spirotetramat is applied according to the intended cGAPs. The use in currant cannot be granted as the existing EU MRL is expected to be exceeded. An authorization can be granted for the use of spirotetramat in raspberries and blackberries as the product will be applied on the stalks after the edible fruits are collected, whereby no MRL is relevant. Furthermore, authorization of the intended use of spirotetramat in beans and peas (with pods) was withdrawn by the applicant since a sufficient number of supervised residue trials is not available. Lastly, the use in fibre crops can only be authorised if a restriction is set on the product label that the commodities should not be consumed by humans or livestock.

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

Based on data provided in this submission, appropriate endpoints were used to calculate PECs for MOVENTO, spirotetramat and its metabolites in soil, surface water, ground water and air for the intended use patterns.

The use patterns evaluated in the core assessment are presented below.

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Re-registration: Application pattern evaluated in the Core assessment - Central Zone Member Crop Timing of Number of Appl. Max. single Max application rate, state application applications interval label rate individual treatment min. [g a.s./ha] BBCH max. [days] [L/ha] Spirotetramat 69 – 81 NLD Pome & stone fruit 1 1) 8) 2 14 1.0 150 MAY-SEP 69 – 81 NLD Pome & stone fruit 2 2) 8) 2 14 0.75 112.5 MAY -SEP AUT, CZE Hop, common 31 – 75 1 - 1.0 150 AUT, GBR, Leafy vegetables 1 3) 12 – 49 2 14 0.5 75 IRE, NLD DEU Leafy vegetables 2 4) 12 – 49 3 14 0.48 72

DEU Leafy vegetables 3 5) 12 – 49 2 14 0.48 72

DEU Onion (garlic, shallot) 13 – 47 4 7 0.48 72 13 – 47 NLD Onion 2 7 0.5 75 APR -OCT Herbs 12 – 48 NLD 2 14 0.5 75 (aromatic and medicinal) APR -OCT 69 – 81 NLD Grape, European 8) 2 14 0.6 90 JUL -SEP 71 – 79 NLD Legume vegetables 6) 2 14 0.5 75 MAY -OCT 12 – 56 Strawberries NLD and 71 - 97 2 14 0.5 75 (not for fruit production) MAR -NOV 91 – 92 NLD Berries (after harvest) 2 14 0.5 75 JUL -NOV 69 – 89 NLD Floricultural crops 8) 4 14 0.5 75 JAN -DEC 69 – 89 NLD Perennials 8) 2 14 0.5 75 JAN -DEC 69 – 89 NLD Tree nursery 8) 2 14 0.6 90 APR -SEP 69 – 89 NLD Flower bulbs 8) 4 14 0.5 75 APR -NOV 69 – 89 NLD Fibre crops 7) 8) 2 14 0.5 75 APR-OCT Plant breeding and seed 69 – 91 NLD 2 14 0.5 75 production 8) APR-OCT 1) i.e., apple, medlar, pear, quince 2) i.e., apple, apricot, cherry, medlar, nectarine, peach, pear, plum, quince 3) i.e., broccoli, Brussels sprouts, chicory Witloof, Chinese-, Savoy-, red and white cabbage, cauliflower, endive (scarole), curly kale, turnip kale, lettuce, Lamb’s lettuce, rucola, spinach 4) i.e., Chinese cabbage and curly kale 5) i.e., broccoli, Savoy-, red and white cabbage, cauliflower, turnip kale, lettuce 6) i.e., climbing beans, garden peas 7) i.e., hemp, flax and nettle 8) Applications only: “after flowering - no flowers present anymore”

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Label extension: Application pattern evaluated in the Core assessment – Central Zone Member Crop Timing of Number of Appl. Max. single Max application rate, state application applications interval label rate individual treatment min. [g a.s./ha] BBCH max. [days] [L/ha] Spirotetramat DEU Hop, common 31 - 75 1 - 1.0 150

DEU Chicory Witloof 13 - 49 2 14 0.5 75

DEU Leafy vegetables 1) 12 – 48 2 14 0.48 72 AUT, CZE, Onion (garlic, shallot) 13 – 47 4 7 0.48 72 GBR, IRE AUT, GBR, Potato 3) 69 – 95 4 7 0.48 72 IRE, NLD Currant 3) NLD 71 – 85 2 14 0.5 75 (red, white, black) 49 – 56 NLD Strawberry, garden 2) 2 14 0.5 75 and 93 – 97 1) i.e., lettuce, spinach 2) No application possible less than 14 days before flowering, during flowering and until last harvest. 3) Applications only: “after flowering - no flowers present anymore”

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

PEC soil calculations as presented in the core assessment for this product are applicable for The Netherlands. No National Addendum considering national specific requirements is needed.

Only exposure assessment following outdoor uses has been performed since there is currently no European guidance for indoor uses.

PEC soil modelling approach Calculations were based on a simple first tier approach (Excel sheet) assuming even distribution of the compound in upper 0-5 cm soil layer. A standard soil density of 1.5 g/cm 3 was assumed. Crop interception data which correspond to the intended growth stages were taken from the FOCUS groundwater guidance paper (FOCUS 2012). Crop interception will reduce the amount of a compound reaching the soil and therefore this has been taken into account depending on the growth stage at application. The interception rates follow the recommendations of the FOCUS groundwater guidance paper (FOCUS 2012).

As pome & stone fruits, hops, grapes, floricultural crops, perennials, fibre crops, tree nursery, flower bulbs, currants (= berries), leafy vegetables and plant breeding / seed production have not been defined in the FOCUS groundwater guidance paper, apples, vines, vines, field beans, cereals, cereals, apples, onions, bush berries, and cabbage (covering broccoli, cauliflower, cabbage, curly kale, endive, Lamb’s lettuce, lettuce, rucola and spinach), sugar beets (covering chicory, kohlrabi (turnip kale), tomatoes (covering Brussels sprouts), field beans (covering herbs) and potatoes were chosen as surrogate crops.

The results for PEC soil for the active substance and its metabolites were used for the eco-toxicological risk assessment.

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

PEC GW calculations as presented in the core assessment for this product are not fully applicable for The Netherlands. A National Addendum considering national specific requirements is presented. In this National Addendum GeoPEARL 3.3.3. calculations are presented (described below). In order to have an absolute worst-case estimation of the PECgw, the RMS recalculated the worst-case GAP, using the default dates (May 25 th , November 1 st ) and scenario (Winter Cereals) in PEARL. This also covered the outdoor uses. No risk for leaching was expected; all PECgw values were below the trigger values.

PEC gw modelling approach Predicted environmental concentrations of the active substance spirotetramat and its metabolites in groundwater recharge (PEC gw ) were calculated using the GeoPEARL model. The GeoPEARL model is a spatially distributed pesticide leaching model that calculates leaching of pesticides and metabolites to the uppermost groundwater for a number of plots, i.e. a combination of soil and weather conditions, representing the area of use (Tiktak et al., 2003) 2. For Dutch pesticide registration procedure the most important value is the 90 th area-weighted percentile of the median leaching concentration over a period of 20 years. For practical reasons a number of 252 plots were selected for each crop.

The interception rates follow the FOCUS recommendations. As pome & stone fruits, leafy vegetables and currants have not been defined in the FOCUS groundwater guidance paper, fruit trees, cabbage and soft fruit crops were chosen as a surrogate crop.

Conclusion The models predict that the spirotetramat and its metabolites will not be found in ground water at concentrations greater than 0.1 μg/L. Based on the assessment, the use of spirotetramat is not expected to lead to leaching into groundwater at levels that would be unacceptable when applied according to the recommended use pattern, based on the GeoPEARL and worst-case PEARL calculations.

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

PEC sw and PEC sed calculations as presented in the core assessment for this product are not fully applicable for The Netherlands. A National Addendum considering national specific requirements is presented.

PEC sw modelling approach The aquatic exposure via spray drift entry was estimated for the Dutch standard scenario via the TOXSWA simulation model, as required by the Dutch registration procedure for plant protection products. Since TOXSWA cannot simulate the formation and fate of degradates, the metabolites were addressed in separate model runs assuming a theoretical application of each metabolite at a rate derived as the product of the use rate of the parent, the maximum formation of the metabolite in water and the molar correction factor (ratio of molar mass metabolite / molar mass parent).

Scenario relevant for the use in various crops in the Netherlands According to the use pattern, PEC sw and PEC sed were calculated for the Dutch spring and autumn scenario after use in soft and large fruit crops, bulbs, field crops and for greenhouse uses using standard spray drift rates.

2 Tiktak A., van der Linden A.M.A. and Boesten J.J.T.I., 2003: The GeoPearl Model. Model description, applications and manual. National Institute of Public Health and the Environment RIVM, Bilthoven, NL. RIVM report 716601007/2003

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Conclusions The results for PEC sw and PEC sed for the active substance and its metabolites were used for the ecotoxicological risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PEC Air ) (Part B, Section 5, Point 9.9) No specific information is available for the preparation, however the information on the active substance submitted in the relevant Annex II, Section 5 and evaluated in the Draft Assessment Report Volume 3 Annex B.8.8 is considered as adequate. The relevant residue for quantification in air is the parent compound and its main degradate spirotetramat-enol (EFSA peer review conclusion). A summary of this information is presented below. Based on the low vapour pressure of 5.6 × 10 -9 Pa (at 20 °C) and the Henry law constant of < 10 -7 Pa m3 mol -1 it can be concluded that significant volatilisation of spirotetramat is not to be expected. Furthermore, due to the short chemical lifetime of spirotetramat and spirotetramat-enol in the troposphere of approx.. 1.7 hours (12-hrs day; 1.5 × 10 -6 OH - cm -3), an accumulation in the air and a contamination by wet or dry deposition can be excluded. If formed via photo-transformation, the metabolites 4-methoxy cyclohexanone and 4-methoxy cyclohexylamino carboxylic acid indicate some volatility. However, persistence in air is not given. DT 50 in air were estimated to be 4.36 and 2.80 hours, only.

Implications for labelling resulting from environmental fate assessment : None

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3.1.6. Ecotoxicology (Part B, Section 6, Point 10)

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

As birds are unlikely to be exposed to the formulation following a use in greenhouse and as there is currently no European guidance on the risk assessment for greenhouse uses, only a risk assessment for field uses was performed.

Birds

A dietary core assessment for the product is presented in the core assessment. The use in herbs is considered similar to be covered by the scenario for leafy vegetables (realistic worst- case) Fiber crops consist of crops belonging to the leafy vegetables (different BBCH stage) and the oilseed rape scenario (not performed). Worst-case short-cut value for these scenarios at this stage is 8.2. This scenario is covered by the more worst-case scenarios for flowerbulbs (4 x 75 g a.s./ha,, short-cut value of 9.7), which passess the first tier assessment in the core.

Plant breeding crops and seeds production includes almost all possible scenario’s. On the WG cereal and grasslands, fruits are excluded. The proposed use is late application (after flowering). This means that due to interception, and the results of the tier 1 assessment for all other uses, the main issue will be on the insectivorous birds. The risk assessment for these birds (including refinements) are similar or even less worst-case than the risk assessment for other insectivores, (orchards, ornamental/ nurseries) therefore this application fall within the risk envelope of the core dossier. The risk from secondary poisoning was assessed following NL specific guidelines and was considered to be low. The plant metabolites of spirotetramat are covered by existing ecotoxicology or toxicology studies, or they were shown not to be toxic to terrestrial vertebrates. In so far, it is justified to base the risk assessment on spirotetramat for birds on the parent compound.

There is no indication that the formulated product is more toxic than expected according to its active ingredient content. Therefore, the risk assessment is based on the endpoints determined with the active ingredient.

Birds may be exposed to the product mainly by the consumption of contaminated feed like insects or via residues on ingested parts of plants.

According to the EFSA Guidance Document on Risk Assessment for Birds & Mammals (2009) the risk to birds from the use of the product according to the intended use pattern is acceptable.

Terrestrial vertebrates (other than birds)

As mammals are unlikely to be exposed to the formulation following a use in greenhouse and as there is currently no European guidance on the risk assessment for greenhouse uses, only a risk assessment for field uses was performed.

A core assessment for the product is presented, fully applicable for The Netherlands.

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The plant metabolites of spirotetramat are covered by existing ecotoxicology or toxicology studies, or they were shown not to be toxic to terrestrial vertebrates. In so far, it is justified to base the risk assessment on spirotetramat for mammals on the parent compound.

According to the EFSA Guidance Document on Risk Assessment for Birds & Mammals (2009) the risk to mammals from the use of the product according to the intended use pattern is acceptable.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) The risk assessment is based on Guidance Document on Aquatic Ecotoxicology, SANCO/3268/2001, rev 4 final, 17 October 2002. Toxicity exposure ratios (TER values) are calculated based on the most sensitive species and worst-case PEC SW values.

The aquatic risk assessment revealed TERs above the trigger for all organisms for the worst-case use in hops, covering all other uses. No mitigation measures are required.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

Bees

As free-ranging honeybees are not exposed to the formulation following a use in greenhouse, only a risk assessment for field uses was performed.

An indication of hazard (Hazard Quotient or Q H) can be derived according to the EPPO risk assessment scheme, by calculating the ratio between the application rate (expressed in g/ha) and the lowest laboratory contact and oral LD 50 (expressed in µg/bee).

The hazard quotient for oral exposure or for contact exposure is below the trigger value of 50 (i.e. Q HO < 50). Thus, no unacceptable acute risk to adult honey bees is to be expected when the product is used according to the proposed use pattern. A further consideration of risks to adult honey bees is therefore not required.

However, due to its mode of action (inhibition of acetyl-CoA carboxylase, a key enzyme in the fatty acid biosynthesis), spirotetramat (esentially its metabolite spirotetramat-enol) has the intrinsic property to affect insect larval development and as such also the larval development of honey bee brood.

It can be however concluded from the available field studies in target crops - conducted under realistic- worst case use conditions - that spirotetramat can be applied via foliar application to various flowering crops without adverse effects on honey bee brood development, honey bee colony performance, storage behaviour of exposed honey bee colonies, mortality, foraging activity, behaviour, colony vitality and colony survival. It can be further concluded that such foliar applications do not interfere with bee keeping activities under typical commercial use conditions.

Bees can be exposed off-field, in flowering margins and/or bordering fields. The same HQ approach is used as for in-field. The off-field exposure is calculated with the drift values used for the off-field risk assessment for other non-target arthropods. Glasshouse uses are not part of this risk assessment However, as indicated in the core dossier, the standard risk assessment is already acceptable for the in- field, but there are concerns about the effects on bee brood. There is no endpoint established that can be used for the risk assessment on bee brood in the off-field and therefore no standard off-field risk assessment can be performed.

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It should be noted that the risks for bees is inclonclusive as it is uncertain if bee brood is affected at relevant (in-field) exposure rate. However it should be noted that off-field exposure is lower. Considering the risk for non-target arthropods, off-field exposure should not exceed 0.51 g a.s./ha (see section 10.5). It is expected that at this low exposure rates, the risk to bee brood will also be acceptable, since one field study already showed no effects at a much higher exposure rate, and the established effects on bee brood were also only found at higher exposure rates.

To prevent flowering of weeds in the field, Spe 8 can be prescribed:

“Dangerous to bees. To protect bees and pollinating insects do not apply to crop plants when in flower. Do not use where bees are actively foraging. Do not apply when flowering weeds are present.”

For the off-field, the same mitigation measures as required for non-target arthropods, should be used.

Other non-target arthropods

Toxicity tests on non-target arthropods were conducted with MOVENTO on the sensitive standard species Typhlodromus pyri and Aphidius rhopalosiphi . In addition, Coccinella septempunctata and Chrysoperla carnea were tested. The available extended laboratory data clearly indicate that Typhlodromus pyri is the most sensitive tested species.

Risk assessment procedures The risk assessment was performed according to the Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) and the Guidance Document on regulatory testing and risk assessment procedures for plant protection products with non-target arthropods (ESCORT 2, Candolfi et al. 2000) considering Dutch requirements according to Ctgb, 2013.

In-field risk assessment

As this is not a Dutch specific aspect, a reference is made to the core dosser. However the core excluded the proposed uses in herbs, fibre crops and plant breeding and seed production. However as the dose rates and the application schemes of these uses are similar to the uses discussed in the core Ctgb is of the opinion that the in-field risk assessment in the core can be extrapolated to those uses as well. It should be noted that the aged residue tests in the core dossier showed that only after 56 days ageing, the effects on mites were <50%. Taking into account the multiple applications and the interval, this means that the recovery can only start about 3 months after first application. Due to the late applications (after flowering) it is unlikely that recovery well have taken place before the winter period and that it is questionable if recovery before the next season will occur. On the other hand, as these applications are so late in the season, there is still some time for recovery before the next spraying. Also the in-field study in grape did not show any effects. As it is questionable if this study can be extrapolated to all different uses, it does give some indication on in-field effects.

The only use for which in-field recovery cannot be established is the use in strawberry, as application is possible from BBCH 12-56 and from 71-97 (march-november), meaning that the period between the possible application times is not long enough to ensure recovery of the arthropod community in between applications, or in-between seasons. The GAP is changed and the late application has been removed. Therefore only 2 applications are left at earlier BBCH stage.

For IPM uses the following warning sentence should be placed on the label:

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Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden.

Off-field risk assessment

The off-field risk to non-target arthropods is considered to be acceptable when making use of the following drift reducing measures: - small fruit and fruit crops low dose: DRT 97.5 + 3 meter cropfree zone OR DRT 95 + 4.5 m cropfree zone; - fruit crops high dose: DRT99 + 3 meter cropfree zone OR DRT 97.5 + 4.5 m cropfree zone; - field crops (downward spraying), limiting all applications to maximum 2, in combination with one of the following measures:

Without air assistance - Low boom ID90015 + end nozzle in combination with a total crop free zone of 150 cm (0.7%). - Släpduk XR110015 in combination with a total crop free zone of 175* cm (0.6%) . - Släpduk AI110015 in combination with a total crop free zone of 150 cm (0.3%). - Tunnel XR11004 + UB8504 (0.26%). - Conventional ID12002 in combination with a total crop free zone of 225 cm (0.7%). - Conventional XLTD04-110 in combination with a total crop free zone of 225 cm (0.8%).

With air assistance - Conventional ID12002 + end nozzle in combination with a total crop free zone of 200 cm (0.7%). - Conventional XLTD04-110 + end nozzle in combination with a total crop free zone of 200 cm (0.6%). - Low boom DG80015 + end nozzle in combination with a total crop free zone of 150 cm (0.6%). - Low boom ID90015 + end nozzle in combination with a total crop free zone of 125 cm (0.5%). - Conventional DG11004 + end nozzle Hardi TwinForce (0.7%) . - R11004 + Hardi Twin Force + 225 cm crop free (0.5%)

- tree nursery : . high lane trees: DRT50 + 5 meter cropfree zone (total crop-free zone of 7 m) . transplanted trees/spindle trees: DRT0 + 5 meter cropfree zone (total crop-free zone of 10 m)

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)

Earthworms

A core assessment for the product is presented, fully applicable for The Netherlands.

Due to the extremely short DT 50 soil of BYI 08330, a chronic exposure of earthworms to the parent compound can be excluded. Therefore, it was considered more appropriate to conduct a chronic earthworm study with the enol- metabolite rather than with the parent compound. The enol-metabolite is the first downstream metabolite of BYI08330, its soil DT 50 is 2.95 days. Soil organisms may thereby be chronically exposed to the enol and further downstream metabolites rather than to the parent compound.

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The risk assessment procedure follows the requirements as given in the Guidance Document on Terrestrial Ecotoxicology.

The acute and chronic TER values are above the trigger for the worst-case PEC, indicating no unacceptable risk for earthworms for both, re-registration and label-extension GAPs.

Effects on other soil non-target macro-organisms

A core assessment for the product is presented, fully applicable for The Netherlands.

According to the Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, SANCO/10329/2002-final, tests with additional soil non-target macro-organisms are required only for persistent substances with a field DT 90 > 100 d. Since the field DT 90, soil of spirotetramat is clearly below the trigger value of 100 days (1.1 days; worst case value in laboratory test), no concern of effects on other soil non-target macro-organisms due to the use of this compound is indicated and studies on spirotetramat with soil non-target macro-organisms would not be required. Even though the DT90, soil of BYI 08330-enol is < 100 days (64.4 d), a study has been conducted with the metabolite and the soil mite Hypoaspis aculeifer.

The TER values are above the trigger based on the worst-case PECsoil values, indicating no unacceptable risk for soil non-target macro-organisms for all GAPs .

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)

A study on the organic matter breakdown is not required based on the DT 90, f value of the active substance and acceptable TER values for earthworms, soil macro-organisms and/or soil micro- organisms.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) A core assessment for the product is presented, fully applicable for The Netherlands.

As both tests for nitrogen and carbon transformation conducted with the active substance showed no influence up to the ten-fold overdose, a study with the formulated product was not deemed necessary.

The lack of effects of the formulation to carbon and nitrogen transformations at rates substantially higher than the maximum application rate proposed for MOVENTO clearly indicates that there is no risk of significant adverse effects of this formulated product on the activity of soil micro-organisms.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Since non-target plants are non-crop plants located outside the treated area (off-crop) (i.e. outside the greenhouse), it is expected that the application of the product in greenhouses according to the intended use pattern will not lead to a contamination of non-target plants. Hence, only a risk assessment for field uses was performed.

A core assessment for the product is presented, not fully applicable for The Netherlands. In addition, a National Addendum considering national specific requirements is presented.

Non-Target Plants

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The risk assessment is based on the ‘Guidance Document on Terrestrial Ecotoxicology’ (SANCO/10329/2002 rev2 final, 2002) and the current version of the Ctgb Manual (Ctgb 2013, Evaluation manual for the authorisation of plant protection products and biocides; Chapter 7 Ecotoxicology: terrestrial; non-targets, version 1.0; January 2013). It is restricted to off-field situations, as non-target plants are non-crop plants located outside the treated area. Spray drift from treated areas may lead to residues of a product in adjacent off-crop habitats.

Effects on non-target plants are of concern in the off-field environment, where they may be exposed to spray drift. Country specific drift values for the Netherlands required for the exposure calculations were taken from the Ctgb Manual (Ctgb, 2013 The Multiple application factors (MAF) will be chosen according to ESCORT2 (Candolfi et al. 2000 ). The most sensitive endpoint for Non-target terrestrial plants is derived from a Vegetative Vigour study demonstrating that this exposure path (i.e. overspray of seedlings) is more sensitive than the overspray of soil surface (as in a Seedling Emergence study). Therefore, the MAF will be used in the risk assessment in accordance with ESCORT2 (cf. IIIA 10.5):

According to the Ctgb Manual and the Terrestrial Guidance Document 3 the risk to non-target terrestrial plants is assessed by comparing the lowest ER 50 from the laboratory studies with the calculated Predicted Environmental Rates (PER). A trigger of 5 can be accepted if at least 6 plant species have been tested.

Based on the lowest ER50 determined for non-target terrestrial plant, the TER is above the trigger of 5 for all re-registration uses except fruit crops. A refined assessment is therefore required for fruit crops.

Refined risk assessment for fruit crops For the use in fruit crops, drift mitigation is required. Based on the ER50 of 134 g a.s./ha, a maximum PER of 26 is allowed, corresponding to a maximum drift of 10%. As the mitigation measures in the assessment for non-target arthropods is more strict with a maximum drift percentage <1%, referral is made to the drift reduction for non-target arthropods. Furthermore as the Activity Decree is into force, the measures included in the Activity Decree are stringent enough to meet the maximum drift rate of 10%, taking into account only the full leaf stage in line with the GAP.

Other non-target species (Flora and Fauna)

Tests on other non-target species are not required.

Implications for labelling resulting from ecotoxicological assessment:

A restriction sentence is required to protect bees:

Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit product niet gebruiken op in bloei-staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen en hommels. Gebruik dit product niet wanneer bloeiende onkruiden aanwezig zijn. Verwijder onkruid voordat het bloeit. Na een gewasbehandeling percelen nog minimaal twee weken vrijhouden van bloeiende onkruiden.

3 Anonymous (2002b). Guidance Document on terrestrial ecotoxicology under council directive 91/414/EEC. SANCO/10329/2002. 17 October 2002.

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Voor bedekte teelten geldt dat gebruik wel is toegestaan op bloeiende planten mits er geen bijen of hommels in de kas actief naar voedsel zoeken. Voorkom dat bijen en andere bestuivende insecten de kas binnenkomen door bijvoorbeeld alle openingen met insectengaas af te sluiten.

Gebruik in de onbedekte teelt van aromatische of medicinale kruidgewassen (m.u.v. kamille) is alleen toegestaan wanneer deze in het veld niet tot bloei komen. In de onbedekte teelt van aromatische of medicinale kruidgewassen (m.u.v. kamille) die wel tot bloei komen is gebruik alleen na de bloei toegestaan.

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in een dosering tot maximaal 0,75 L/ha in de teelt van appel, peer, kers, pruim, pit- en steenvruchten, in de teelt van druif en in de teelt van braam- en framboosachtigen uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT97,5, of DRT95 in combinatie met een teeltvrije zone van 450 centimeter (gemeten vanaf het midden van de laatste bomenrij/struikrij of de laatste boom/struik in de rij tot aan de perceelgrens).

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in een dosering boven 0,75 L/ha in de teelt van appel, peer, kers, pruim en overige pit- en steenvruchten uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT99, of DRT97,5 in combinatie met een teeltvrije zone van 450 centimeter (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens).

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten te beschermen is toepassing van dit middel in de teelt van vezelgewassen, witlof, aardbei, sla, andijvie, spinazie-achtigen, koolgewassen, uien, sjalotten, aardappelen, bloembol- en bloemknolgewassen, vaste plantenteelt, veldsla, rucola, aromatische kruidgewassen, medicinale kruidgewassen met uitzondering van kamille, bloemisterijgewassen, boomkwekerijgewassen (neerwaarts bespoten) en de teelt van veredeling en zaadteelt van diverse gewassen uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van één van de volgende maatregelen:

Zonder luchtondersteuning:- sleepdoek spuitsysteem met spuitdoppen met tenminste druppelgrootte F en een kantdop met tenminste druppelgrootte F bij een spuitdophoogte van maximaal 20 cm in combinatie met een teeltvrije zone* van 175 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - sleepdoek spuitsysteem met spuitdoppen met tenminste DRD50 en een kantdop met tenminste DRD50% bij een spuitdophoogte van maximaal 20 cm in combinatie met een teeltvrije zone* van 150 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - Tunnelspuit voor beddenteelt (=overkapte beddenspuit) in combinatie met spuitdoppen met een tophoek van 110-120° en tenminste druppelgrootte M en een kantdop aan beide kanten van de spuit met tenminste druppelgrootte M; - Veldspuit met spuitdoppen met tenminste DRD75% en een kantdop met tenminste DRD75% in combinatie met een teeltvrije zone* van 225 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens). * De teeltvrije zone geldt vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens.

Met luchtondersteuning:- Veldspuit met spuitdoppen met tenminste DRD75% en een kantdop met tenminste DRD75% in combinatie met een teeltvrije zone* van 200 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - veldspuit met verlaagde spuitboom in combinatie met een spuitdophoogte van maximaal 30 cm met een dopafstand 25 cm en spuitdoppen tenminste DRD 50% met een tophoek van maximaal 90° en

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 41 of 114 bijbehorende driftarme kantdopin combinatie met een teeltvrije zone* van 150 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - Hardi Twin Force luchtondersteunde veldspuit in combinatie met spuitdoppen van tenminste DRD 50% en bijbehorende driftarme kantdop bij een rijsnelheid van maximaal 12 km/u g; - Hardi Twin Force luchtondersteunde veldspuit en bijbehorende driftarme kantdop bij een rijsnelheid van maximaal 12 km/u in combinatie met een teeltvrije zone* van 225 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens);. * De teeltvrije zone geldt vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens.

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in de teelt van hoge laanbomen uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT50 in combinatie met een totale teeltvrije zone van 700 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens).

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in de teelt van boomkwekerijgewassen (spillen en opzetters) uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT0 in combinatie met een totale teeltvrije zone van 1000 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens).

For IPM uses a warning sentence must be placed on the label:

Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg deskundigen (uw leverancier van natuurlijke vijanden, de producent van dit middel, uw adviseur) over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden.

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3.1.7. Efficacy (Part B, Section 7, Point 8)

The application concerns re-registration of MOVENTO (OD, 150g/L spirotetramat) with extention of uses. In the Netherlands the extention of uses are controling of Aphids in strawberry, HYPELA in currant, Aphids in potato and THRITB and CONTA in Brassica’s. Bridging trials were conducted in efficacy trials between SPT OD150 and SPT SC100. The Neterhlands as CMS considers the valid data in Maritime zone for the above mentioned uses in this application.

According the GAP the following restrion for spray volume is given on the label: In de teelt van pitvruchten, steenvruchten, braam- en framboosachtigen, bloemsiterijgewassen, boomkwekerijgewassen en vaste plantenteelt het middel toepassen in minimaal 1000 liter water per ha. In de teelt van druif het middel toepassen in minimaal 1200 liter water per ha.

Minimum effective dose and efficacy tests:

Aphids in potato MED 11 GEP trials were conducted in 2012 in order to determine the Minimum Effective Dose of SPT SC100 and SPT OD150 against aphids in potato, in Germany, Poland, France (Maritime Zone) and the Netherlands. Sufficient number of trials showed that the proposed dose of 75g Spirotetramat 150OD/ha was necessary to provide sufficient control of the pest. In the Dutch GAP, 0.48 l/ha, 0.072 kg as/ha are proposed. As the difference between the GAP (72g) and tested dose (75g) is less than 10%, the trial data are acceptable for authorization. Given the presented data, efficacy against aphids (given adequate extrapolation evidence) in potato with 75g Spirotetramat 150OD/ha is justified.

Efficacy Data of 10 efficacy trials (GEP) from Maritime zone are presented. In the DRR tested organisms MYZUPE ( Myzus persicae ) and APHINA (Aphis nasturtii ) were reported with sufficient number of trials. Other aphid species AULASO ( Aulacorthum solani ), MACSEU ( Macrosiphum euphorbiae ) and APHIFA (Aphis fabea) were removed from the WG as the trial list (drr B7) indicated insufficient number of trials. Extrapolation possibilities are not known. SPT SC100 and SPT OD150 at the proposed dose of 75 g a.s./ ha showed good control of aphids in potato. The efficacy of the two formulates is comparable with that of the reference product. NL agrees with the ZRMs that the provided data is sufficient in supporting for authorization in Maritime zone, and taint is to be expected based on the trials for yield and quality. AULASO, MACSEU and APHIFA are not surpported.

THRITB in onion Onion is an existing use in NL, and the dose rate does not change. The new application covers the use in garlic and shallot, which can be extrapolated from onion.

MED The minimum effective dose for Thrips tabaci control in onion has been determined in 4 field trials carried out in 2004 by Bayer CropScience in Hungary and Germany, using Spirotetramat OD100 as a representative formulation. Trials of OD 150 and SC 100 were conducted separately. Proposed dose of 75 g a.s./ha, provided good control of feeding damage. In the SC trials only one lower dose rate was tested.

Efficacy 11 trials are presented showing the efficacy of SPT OD150 against onion thrips Thrips tabaci in onion, shallot and garlic.

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 43 of 114

From zRMS evaluation: “Variance between the formulations OD150 and SC100 exists. The trials conducted with OD150 formulation were conducted with three application throughout the trial period. In most countries registration is sought for 4 applications per year, except for the Netherlands, where only two applications are intended for registration. For registration in the Netherlands, three valid trials with 2 applications per season show efficacy similar to the reference product.”

As as is an existing use in NL no additional data is required. According to Dutch extrapolation table extrapolation to garlic and shallot is possible. Garlic is later withdrawn by the applicant.

THRITB in brassicas MED No Minimum Effective Dose was conducted with SPT OD150, but with SPT SC100. Only two trials are conducted in Maritime zone.

From zRMS evaluation: “Trial two does not include the damage on untreated plants, which makes it impossible to judge about the control provided by SPT. The dose of 75 g a.s./ha was able to reduce the number of insects better than the lower dose, but was still far behind the knock-down effect of the reference products. Efficacy in preventing leaf damage was similar for all products and doses. The given trials are not supportive of Minimum Effective Dose of 75 g a.s./ha “

NL agrees with the conclusions of ZRMS. A minimum effective dose of 75g a.s/ha can not be supported for control of thrips in Brassicas.

Efficacy 8 GEP trials were conducted between 2006 and 2013 with SPT SC100 and/or SPT OD150. Trials were carried out by Bayer in FRA and NLD, in the Maritime climatic zone.

From zRMS evaluation “SPT SC100 provided insufficient control against THRITB in brassicas when applied only 2 times throughout the season. However the reference product did not provide better control than SPT. Trials consisting of 2 application were conducted only with the SC100 formulation; the OD150 formulation was used in trials with higher numbers of applications. The low database considering this indication, and the overall meagre control of the product at the intended application rate does not allow conclusions considering the efficacy of OD150 against THRITB in brassicas and registration therefore cannot be recommended. “

NL agrees with the conclusions of ZRMS. The data provided are not sufficient for authorization of the product against thrips in brassicas in NL.

CONTNA in brassicas MED No minimum effective dose data was provided for Contarinia nasturtii control in brassicas.

Efficacy 8 field trials, broccoli (Dutch trials) or Brussels sprouts (Belgian trials), under natural infestation of swede midge. The proposed dose of 75 g a.s./ha were tested against swede midge in Broccoli with two to four applications. with the OD150 and SC100 plus and additive.

Comments zRMS pointed out that : the efficacy differences appeared in trials between the two formulations. Under the high pest pressure during two trials, the OD150 formulation did not provide sufficient control of the pest, whereas the SC100 + additive formulation showed better results in controlling both pest incidence and severity.

As no minimum effective dose is provided and based on the conclusion of the ZRMS, NL considers that the data is not sufficient to support the claim.

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 44 of 114

Aphids in strawberries MED and Efficacy Data of 6 trials conducted in the Netherlands were presented. Different aphid species ( Rhodobium porosum, Macrosiphum euphorbiae, Aphis spp, Acyrtosiphon kondoi, Macrosiphum rosae ) were tested. Spirotetramat OD 150 at proposed rate provided good control to the target pest and showed comparable or higher efficacy than the reference product. NL agrees with the ZRMS that the data provided are acceptable for authorization of the claimed aphids in strawberries.

HYPELA in black currant -The use against Hyperomyzus lactucae on currant is moved to minor use by the applicant. One trial on HYPELA was conducted in the UK. More trials on other target organisms were tested. High efficacy was shown from the one trial. Additionally other aphids were tested in Maritime zone.

ZRMS conclused tha: Trials from the Maritime zone show that the intended dose of 75 g a.s./ha provides good control of various aphids;Trials conducted in the North-East zone (Poland) can be evaluated as additional information. Registration can therefore be supported.

NL as CMS follow the conclusions of the ZRMS and authorize the product to product HYPELA at proposed dose. Extrapolation is possible from black currant to other currant.

Adverse effects

Phytotoxicity to host crop Phytotoxicity was assessed in the efficacy trials at max rate of 75 g a.s/ha in 13 potato variaties. The trials was conducted in Maritime and North-east zone. Phyotoxicity was also assessed in onion. None of the trials showed signs of phytotoxicity. Phytotoxicity data for aphids in strawberry is available in the interzonal dossier evaluated by Austria. Strawberry is already authorized in the Netherlands for propagation crops, with this dossier the applicant intends to extend the use to production crops. The label extension is limited, according to the GAP, apply 14 days before flowering, during flowering and until last harvest, or apply post-harvest. Brassicca crops have also been authorised in the Netherlands against other insect pests. Thus no additional phytotoxicity is expected in the extended use in strawberry and Brasicca crops. Phytotoxicity data for currants is not provided. The use is moved to minor use by the applicant.

According the currently authorised label the following restrion for spray volume is given on the label: Gevoeligheid gewassen In een aantal appelrassen kan MOVENTO fytotoxiciteit geven.

Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden van boomkwekerijgewassen, vaste planten, bloembollen- en bolbloemen en groenteteeltgewassen en de verschillen in gewasverdraagzaamheid, verdient het aanbeveling om alvorens het middel toe te passen een proefbespuiting uit te voeren. Na de proefbespuiting 14 dagen wachten om vast te stellen of een bespuiting van het middel gewaseffecten veroorzaakt.

Het middel niet toepassen in Salix (Salicaceae).

Adverse effects on parts of plant used for propagating purposes On potato 3 trials were carried out in the Netherlands to check daughter tubers, following the use of spirotetramat OD150 at 75 g a.s/ha (4-6 applications). Tuber emergency and biomass was recorded. The results showed no adverse effect. NL agrees with the ZRMS that no effects on plants for propagation purpose are to be expected.

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 45 of 114

Impact on succeeding crops NL agrees with the ZRMS that no impact on succeeding crops is to be expected.

Impact on other plants including adjacent crops NL agrees with the ZRMS that no impact on other plants is to be expected.

Possible development of resistance or cross-resistance In the Netherlands the following resistance management sentences are required as in the old label.

Resistentiemanagement Dit middel bevat de werkzame stof spirotetramat. Spirotetramat behoort tot de acetyl CoA carboxylase remmers. De IRAC code is 23. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

3.2. Conclusions

Mammalian Toxicology Overall, it is concluded that the use of MOVENTO, in the field and in greenhouses, does not result in an unacceptable risk for operators, bystanders, residents and workers.

Residues and Consumer Exposure From a viewpoint of residues and consumer safety, an authorisation can be granted in pome fruits, peach/nectarine/apricot, plum, grape, strawberry, potatoes, onion, shallots, flowering brassica, Brussels sprouts, head brassicas (cabbage- white, red, savoy), leafy brassicas (Chinese cabbage, Kale), kohlrabi, lettuce and other salad plants, spinach & similar (leaves), witloof (chicory witloof) and herbs (medicinal and aromatic) if spirotetramat is applied according to the intended cGAPs. The use in currant cannot be authorised as the existing EU MRL is expected to be exceeded. An authorization can be granted for the post-harvest use of spirotetramat in raspberries and blackberries. Furthermore, the intended use of spirotetramat in beans and peas (with pods) was withdrawn by the applicant since a sufficient number of supervised residue trials is not available. Lastly, the use in fibre crops can only be authorised if a restriction is set on the product label that the commodities should not be consumed by humans or livestock.

Ecotoxicology During the evaluation the post-harvest treatment in strawberry has been withdrawn by the applicant.

An authorization can be granted on the conditions that the following restriction sentences are included in the Legal Instructions for Use:

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 46 of 114

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in een dosering boven 0,75 L/ha in de teelt van appel, peer, kers, pruim en overige pit- en steenvruchten uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT99, of DRT97,5 in combinatie met een teeltvrije zone van 450 centimeter (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens).

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten te beschermen is toepassing van dit middel in de teelt van vezelgewassen, witlof, aardbei, sla, andijvie, spinazie-achtigen, koolgewassen, uien, sjalotten, aardappels, bloembol- en bloemknolgewassen, vaste plantenteelt, veldsla, rucola, aromatische kruidgewassen, medicinale kruidgewassen met uitzondering van kamille, bloemisterijgewassen en de teelt van veredeling en zaadteelt van diverse gewassen uitsluitend toegestaan indien het middel niet meer dan 2 maal per jaar wordt toegepast en op het gehele perceel gebruikt gemaakt wordt van één van de volgende maatregelen:

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 47 of 114

- Hardi Twin Force luchtondersteunde veldspuit in combinatie met spuitdoppen van tenminste DRD 50% en bijbehorende driftarme kantdop bij een rijsnelheid van maximaal 12 km/u g; - Hardi Twin Force luchtondersteunde veldspuit en bijbehorende driftarme kantdop bij een rijsnelheid van maximaal 12 km/u in combinatie met een teeltvrije zone* van 225 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens);. * De teeltvrije zone geldt vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens.

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in de teelt van boomkwekerijgewassen (spillen en opzetters) uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT0 in combinatie met een totale teeltvrije zone van 1000 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens).

Behandelde vezelgewassen en producten hiervan niet voor menselijke en/of dierlijke consumptie bestemmen

Efficacy Use in hop and the claims against Contarinia nasturtii and Thrips in brassica are withdrawn by the applicant. For the remaining existing crops and claims, an authorization can be granted.

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

None.

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 48 of 114

Appendix 1 – Copy of the product label

Wettelijk gebruiksvoorschrift Het middel is uitsluitend toegelaten als insecten- en mijtenbestrijdingsmiddel voor het professionele gebruik in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.1 Ctgb juni 2015) onder de hierna vermelde toepassingsvoorwaarden.

Toepassingsvoorwaarden: Toepassingsge- Type Werkzaamheid Dosering* Maximal Maximaal Maximaa Minimum Veiligheidster bied toepassing getoetst op middel per e aantal l aantal interval mijn in dagen toepassing doserin toepassin liter tussen g per gen per middel toepassi toepassi teeltcyclus per ha ngen in ng of per 12 per dagen maanden teeltcycl us of per 12 maande n Aardappelen Gewasbehand Bladluis 2,5 0,5 L/ha 0,5 2 per 1 L/ha 7 14 eling na de L/ha teeltcyclus per bloei teeltcycl us Witlof Gewasbehand Bladluis 5 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 14 70 (pennenteelt) eling maanden per 12 maande n Appel Gewasbehand Bladluis 7,8,9,10 0,05% (50 0,75 2 per 12 2 L/ha 14 21 (onbedekte teelt) eling na de ml middel L/ha maanden per 12 bloei per 100 liter maande water) n

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Toepassingsge- Type Werkzaamheid Dosering* Maximal Maximaal Maximaa Minimum Veiligheidster bied toepassing getoetst op middel per e aantal l aantal interval mijn in dagen toepassing doserin toepassin liter tussen g per gen per middel toepassi toepassi teeltcyclus per ha ngen in ng of per 12 per dagen maanden teeltcycl us of per 12 maande n Appelbloedluis 11 0,1% (100 1,0 L/ha ml middel per 100 liter water) Peer Gewasbehand Bladluis 7,10,12,13,14 0,05% (50 0,6 L/ha 2 per 12 2 L/ha 14 21 (onbedekte teelt) eling na de ml middel maanden per 12 bloei per 100 liter maande water) n Bladvlo 15 0,1% (100 1,0 L/ha ml middel per 100 liter water) Kers Gewasbehand Bladluis16 0,05% (50 0,75 2 per 12 1,5 L/ha 14 21 (onbedekte teelt) eling na de ml middel L/ha maanden per 12 bloei per 100 liter maande water) n Pruim Gewasbehand Bladluis 17,18,19 0,05% (50 0,75 2 per 12 1,5 L/ha 14 21 (onbedekte teelt) eling na de ml middel L/ha maanden per 12 bloei per 100 liter maande water) n Aardbei Gewasbehand Bladluis 1,4,5,6,17,20, 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 14 - (onbedekte teelt) eling tot 14 21,22,23,24,25 maanden per 12 dagen voor de maande bloei n

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 50 of 114

Toepassingsge- Type Werkzaamheid Dosering* Maximal Maximaal Maximaa Minimum Veiligheidster bied toepassing getoetst op middel per e aantal l aantal interval mijn in dagen toepassing doserin toepassin liter tussen g per gen per middel toepassi toepassi teeltcyclus per ha ngen in ng of per 12 per dagen maanden teeltcycl us of per 12 maande n Sla Lactuca spp. Gewasbehand Bladluis 5,21,24,26 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 14 7 (onbedekte teelt) eling maanden per 12 maande n Andijvie Gewasbehand Bladluis 5,21,24,26 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 14 7 (onbedekte teelt) eling maanden per 12 maande n Spinazie-achtigen Gewasbehand Bladluis 5,21,24,26 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 14 7 eling maanden per 12 maande n Koolgewassen Gewasbehand Bladluis 27 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 14 3 (onbedekte teelt) eling Wittevlieg 28 maanden per 12 maande n Uien Gewasbehand Trips 29 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 7 7 (onbedekte teelt) eling maanden per 12 maande n Sjalotten Gewasbehand Trips 29 0,5 L/ha 0,5 L/ha 2 per 12 1 L/ha 7 7 (onbedekte teelt) eling maanden per 12 maande n

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Toepassingsge- Type Werkzaamheid Dosering* Maximal Maximaal Maximaa Minimum Veiligheidster bied toepassing getoetst op middel per e aantal l aantal interval mijn in dagen toepassing doserin toepassin liter tussen g per gen per middel toepassi toepassi teeltcyclus per ha ngen in ng of per 12 per dagen maanden teeltcycl us of per 12 maande n Bloembol- en Gewasbehand Bladluis 1,4,5,6,24,30 0,5 L/ha 0,5 L/ha 2 per 12 1,0 L/ha 14 - bloemknolgewass eling na de maanden per 12 en (onbedekte bloei maande teelt) n Boomkwekerijgew Gewasbehand Bladluis 1,4,5,6,24,31, 0,05% (50 0,6 L/ha 2 per 12 1,2 L/ha 14 - assen eling 32 ml middel maanden per 12 (onbedekte teelt) per 100 liter maande water) n Vaste plantenteelt Gewasbehand Bladluis 1,4,5,6,24,33 0,05% (50 0,5 L/ha 2 per 12 1 L/ha 14 - (onbedekte teelt) eling ml middel maanden per 12 per 100 liter maande water) n * Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen. 1. Aardappeltopluis (Macrosiphum euphorbiae) 2. Wegedoornluis (Aphis nasturtii) 4. Boterbloemluis (Aulacorthum solani) 5. Groene perzikluis (Myzus persicae) 6. Zwarte bonenluis (Aphis fabae) 7. Appelgrasluis (Rhopalosiphum insertum) 8. Bloedvlekkenluis (Dysaphis devecta en D. Anthrisci) 9. Roze appelluis (Dysaphis plantaginea) 10. Groene appeltakluis (Aphis pomi) 11. Appelbloedluis (Eriosoma lanigerum)

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018 Part A MOVENTO Registration Report – Central Zone National Assessment - Netherlands Page 52 of 114

12. Roze perenluis (Dysaphis pyri) 13. Vouwgalluis (Anuraphis farfarae) 14. Zwarte perenluis (Melanaphis pyaria) 15. Perenbladvlo (Psylla pyri) 16. Zwarte kersenluis (Myzus cerasi) 17. Gevlekte kortstaartluis (Brachycaudus prunicola) 18. Melige perzikluis (Hyalopterus amygdali) 19. Melige pruimenluis (Hyalopterus pruni) 20. Groene melkdistelluis (Hyperomyzus lactucae) 21. Groene slaluis (Nasanovia ribisnigri) 22. Grote frambozenluis (Amphorophora idaei) 23. Aardbeiknotshaarluis (Chaetosiphon fragaefolii) 24. Katoenluis (Aphis gossypii) 25. Sjalottenluis (Myzus ascalonicus) 26. Bruine slaluis (Uroleucon sonchi) 27. Melige koolluis (Brevicoryne brassicae) 28. Koolwittevlieg (Aleyrodes brassicae) 29. Tabakstrips (Thrips tabaci) 30. Fluitekruidluis (Dysaphis anthrisci) 31. Beukenbladluis (Phyllaphis fagi) 32. Staticobium limonii (Staticobium limonii) 33. Gele rozenluis (Rhodobium porrosum)

Het gebruik in de teelt van vezelgewassen, de teelt van witlof (pennenteelt) ter bestrijding van de wollige slawortelluis, de onbedekte teelt van pitvruchten m.u.v. appel en peer, de onbedekte teelt van steenvruchten m.u.v. kers en pruim, de onbedekte teelt van druif, in de onbedekte teelt van, braam- en framboosachtigen ( Rubus spp.), onbedekte teelt van andijvie ter bestrijding van de wollige slawortelluis, de onbedekte teelt van veldsla, de onbedekte teelt van rucola, de onbedekte teelt van aromatische kruidgewassen en medicinale kruidgewassen (m.u.v. kamille), de bedekte teelt van chrysant, de onbedekte teelt van bloemisterijgewassen en de onbedekte veredelings- en bloemzaadteelt, groentenzaadteelt en onbedekte zaadteelt van kruiden, bieten, peulvruchten, oliehoudende zaden, vezelgewassen, groenbemestergewassen, voedergewassen en overige akkerbouwgewassen is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden komt voor risico en verantwoordelijkheid van de gebruiker.

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Toepassingsgebied Type toepassing Werkzaamheid Dosering Maximal Maximaal Minimum Veiligheidsterm aannemelijk tegen * middel e aantal interval ijn in dagen per dosering toepassing tussen toepassi per en per toepassing ng toepassi teeltcyclus en in dagen ng of per 12 maanden Vezelgewassen Gewasbehandeli Bladluis 1,4,5,6,20,24,30, 0,5 L/ha - 2 per 14 - ng na de bloei 33 teeltcyclus Wortelluis 34 Witlof (pennenteelt) Gewasbehandeli Wortelluis 34 0,5 L/ha 0,5 L/ha 2 per 12 14 70 ng maanden Pitvruchten m.u.v. Gewasbehandeli Bladluis 7,8,9,10,11,12,1 0,05% 0,75 L/ha 2 per 12 14 21 appel en peer ng na de bloei 3 (50 ml maanden (onbedekte teelt) middel per 100 liter water) Gewasbehandeli Appelbloedluis 11 0,1% 1 L/ha ng na de bloei Bladvlo 15 (100 ml middel per 100 liter water) Steenvruchten m.u.v. Gewasbehandeli Bladluis 16,17,18,19 0,05% 0,75 L/ha 2 per 12 14 21 kers en pruim ng na de bloei (50 ml maanden (onbedekte teelt) middel per 100 liter water) Druif Gewasbehandeli Bladluis 5 0,05% 0,6 L/ha 2 per 12 14 14 (onbedekte teelt) ng na de bloei (50 ml maanden middel per 100 liter water)

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Rucola Gewasbehandeli Bladluis 5,21,24,26 0,5 L/ha 0,5 L/ha 2 per 12 14 7 (onbedekte teelt) ng maanden

Aromatische Gewasbehandeli Bladluis 5,26 0,5 L/ha 0,5 L/ha 2 per 12 14 7 kruidgewassen ng op niet- maanden (onbedekte teelt) bloeiende gewassen of na de bloei Medicinale Gewasbehandeli Bladluis 5,26 0,5 L/ha 0,5 L/ha 2 per 12 14 7 kruidgewassen m.u.v. ng op niet- maanden kamille bloeiende (onbedekte teelt) gewassen of na de bloei Chrysant Gewas- Bladluis 1,4,5,6,24,33 0,5 L/ha 0,5 L/ha 2 per 12 14 - (bedekte teelt) behandeling Mijten 39 maanden Trips 40

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Toepassingsgebied Type toepassing Werkzaamheid Dosering Maximal Maximaal Minimum Veiligheidsterm aannemelijk tegen * middel e aantal interval ijn in dagen per dosering toepassing tussen toepassi per en per toepassing ng toepassi teeltcyclus en in dagen ng of per 12 maanden Bloemisterijgewassen Gewasbehandeli Bladluis 1,4,5,6,24,33 0,05% 0,5 L/ha 2 per 12 14 - (onbedekte teelt) ng na de bloei (50 ml maanden middel per 100 liter water) De onbedekte teelt Gewasbehandeli Bladluis 1,5,6,17,20,24,3 0,5 L/ha 0,5 L/ha 2 per 12 14 - van veredeling en ng na de bloei 0,33 maanden bloemzaadteelt, groentenzaadteelt en zaadteelt van kruiden, bieten, peulvruchten, oliehoudende zaden, vezelgewassen, groenbemestergewass en, voedergewassen, witlof (pennenteelt), cichorei, boekweit, meekrap en olifantsgras * Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken.

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1. Aardappeltopluis (Macrosiphum euphorbiae) 4. Boterbloemluis (Aulacorthum solani) 5. Groene perzikluis (Myzus persicae) 6. Zwarte bonenluis (Aphis fabae) 7. Appelgrasluis (Rhopalosiphum insertum) 8. Bloedvlekkenluis (Dysaphis devecta en D. Anthrisci) 9. Roze appelluis (Dysaphis plantaginea) 10. Groene appeltakluis (Aphis pomi) 11. Appelbloedluis (Eriosoma lanigerum) 12. Roze perenluis (Dysaphis pyri) 15. Perenbladvlo (Psylla pyri) 16. Zwarte kersenluis (Myzus cerasi) 17. Gevlekte kortstaartluis (Brachycaudus prunicola) 18. Melige perzikluis (Hyalopterus amygdali) 19. Melige pruimenluis (Hyalopterus pruni) 20. Groene melkdistelluis (Hyperomyzus lactucae) 21. Groene slaluis (Nasanovia ribisnigri) 22. Grote frambozenluis (Amphorophora idaei) 24. Katoenluis (Aphis gossypii) 26. Bruine slaluis (Uroleucon sonchi) 30. Fluitekruidluis (Dysaphis anthrisci) 33. Gele rozenluis (Rhodobium porrosum) 34. Wollige slawortelluis (Pemphigus bursarius) 35. Braamgrasluis (Sitobion fragariae) 36. Grote bramenluis (Amphorophora rubi) 37. Kleine frambozenluis (Aphis idaei) 38. Bessentakluis (Rhopalosiphoninus ribesinus) 39. Bonenspint (Tetranychus urticae) 40. Californische trips (Frankliniella occidentalis)

Overige toepassingsvoorwaarden In de teelt van pitvruchten, steenvruchten, braam- en framboosachtigen, bloemsiterijgewassen, boomkwekerijgewassen en vaste plantenteelt het middel toepassen in minimaal 1000 liter water per ha. In de teelt van druif het middel toepassen in 1200 liter water per ha.

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Behandelde vezelgewassen en producten hiervan niet voor menselijke en/of dierlijke consumptie bestemmen.

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in een dosering tot maximaal 1,0 L/ha in de teelt van appel, peer, kers, pruim en overige pit- en steenvruchten uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT99, of DRT97,5 in combinatie met een teeltvrije zone van 450 centimeter (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens).

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in een dosering tot maximaal 0,75 L/ha in de teelt van appel, peer, kers, pruim en overige pit- en steenvruchten, maximaal 0,6 L/ha in de teelt van druif en maximaal 0,5 L/ha in de teelt braam- en framboosachtigen uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT97,5, of DRT95 in combinatie met een teeltvrije zone van 450 centimeter (gemeten vanaf het midden van de laatste bomenrij/struikrij of de laatste boom/struik in de rij tot aan de perceelgrens).

Zonder luchtondersteuning: - lage spuitboomhoogte (maximaal 30 cm boven de top van het gewas)met minimaal 90% driftreducerende spuitdoppen en een kantdop in combinatie met een teeltvrije zone* van 150 centimeter;

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- sleepdoek met standaard spuitdoppen in combinatie met een teeltvrije zone* van 175 centimeter; - sleepdoek met minimaal 50% driftreducerende spuitdoppen in combinatie met een teeltvrije zone* van 150 centimeter; - overkapte beddenspuit; - minimaal 75% driftreducerende spuitdoppen met een kantdop in combinatie met een teeltvrije zone* van 225 centimeter. * De teeltvrije zone geldt vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens.

Met luchtondersteuning: - minimaal 75% driftreducerende spuitdoppen met een kantdop in combinatie met een teeltvrije zone* van 200 centimeter; - lage spuitboomhoogte (maximaal 30 cm boven de top van het gewas)met minimaal 50% driftreducerende spuitdoppen en een kantdop in combinatie met een teeltvrije zone* van 150 centimeter; - lage spuitboomhoogte (maximaal 30 cm boven de top van het gewas)met minimaal 90% driftreducerende spuitdoppen en een kantdop in combinatie met een teeltvrije zone* van 125 centimeter; - minimaal 50% driftreducerende spuitdoppen in combinatie met Hardi TwinForce luchtondersteuning; - standaard spuitdoppen in combinatie met Hardi TwinForce luchtondersteuning in combinatie met een teeltvrije zone* van 225 centimeter. * De teeltvrije zone geldt vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens.

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in de teelt van boomkwekerijgewassen (spillen en opzetters) uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT0 in combinatie met een totale teeltvrije zone van 1000 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens).

Gevoeligheid gewassen In een aantal appelrassen kan MOVENTO fytotoxiciteit geven.

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Het middel niet toepassen in Salix ( Salicaceae ).

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Appendix 2 – Letter of Access

Spirotetramat is solely owned by Bayer CropScience and no access to third party data is required.

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Appendix 3 – List of data submitted in support of the evaluation

Identity, physical and chemical properties, other information

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.1 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.1 /02 2015 Statement about the determination of the Yes Y Y Bayer odour of spirotetramat OD 150 (150 g/L) CropScience Bayer CropScience, Report No.:FM0222(STM00)N01 Edition Number: M-537942-01-1 Date: 2015-11-04 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.2.1 /01 2007 Safety relevant technical properties of Yes N (not GLP) Y Bayer spirotetramat oil dispersion 150 g/litre CropScience Recipe Identification: Specification number 102000016434 Batch identification: 2006- 008017 Bayer CropScience GmbH, Frankfurt am Main, Germany Bayer CropScience, Report No.: FOR0899(PC)01, Edition Number: M-284069-01-1 Date: 2007-02-19 GLP/GEP: no, unpublished ...also filed: KIIIA 2.2.2 /01 ...also filed: KIIIA 2.3.1 /01 ...also filed: KIIIA 2.3.3 /01 KIIIA 2.2.2 /01 2007 Safety relevant technical properties of Yes N (not GLP) Y Bayer spirotetramat oil dispersion 150 g/litre CropScience Recipe Identification: Specification number 102000016434 Batch identification: 2006- 008017 Bayer CropScience GmbH, Frankfurt am Main, Germany Bayer CropScience, Report No.: FOR0899(PC)01, Edition Number: M-284069-01-1 Date: 2007-02-19 GLP/GEP: no, unpublished ...also filed: KIIIA 2.2.1 /01 ...also filed: KIIIA 2.3.1 /01 ...also filed: KIIIA 2.3.3 /01

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.3.1 /01 2007 Safety relevant technical properties of Yes N (not GLP) Y Bayer spirotetramat oil dispersion 150 g/litre CropScience Recipe Identification: Specification number 102000016434 Batch identification: 2006- 008017 Bayer CropScience GmbH, Frankfurt am Main, Germany Bayer CropScience, Report No.: FOR0899(PC)01, Edition Number: M-284069-01-1 Date: 2007-02-19 GLP/GEP: no, unpublished ...also filed: KIIIA 2.2.1 /01 ...also filed: KIIIA 2.2.2 /01 ...also filed: KIIIA 2.3.3 /01 KIIIA 2.3.3 /01 2007 Safety relevant technical properties of Yes N (not GLP) Y Bayer spirotetramat oil dispersion 150 g/litre CropScience Recipe Identification: Specification number 102000016434 Batch identification: 2006- 008017 Bayer CropScience GmbH, Frankfurt am Main, Germany Bayer CropScience, Report No.: FOR0899(PC)01, Edition Number: M-284069-01-1 Date: 2007-02-19 GLP/GEP: no, unpublished ...also filed: KIIIA 2.2.1 /01 ...also filed: KIIIA 2.2.2 /01 ...also filed: KIIIA 2.3.1 /01

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.4.2 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.4.2 /02 2015 pH-value of spirotetramat OD 150 (150 g/L) Yes Y Y Bayer Bayer CropScience, CropScience Report No.: FM0222(PCR00)N01 Edition Number: M-537965-01-1 Date: 2015-11-04 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.5.1 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.5.2 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.5.3 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.5.3 /02 2015 Content, colour, odour, physical state, No N Y Bayer surface tension (only before storage) and CropScience suspension before and after storage at elevated temperature of spirotetramat OD 150 (150 g/L) - Packaging material: COEX/PA - Final report (14 days) - 1. Amendment Bayer CropScience, Report No.: FM0222(ACR02)N01, Edition Number: M-514148-02-1 Date: 2015-03-20 ...Amended: 2015-05-06 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /04 ...also filed: KIIIA 2.8.3.1 /01

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.6.1 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.7.1 /01 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: HDPE] - Final report Bayer CropScience, Report No.: 2006-008017-01, Edition Number: M-285846-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.3 /01 ...also filed: KIIIA 2.7.4 /01 ...also filed: KIIIA 2.7.5 /01

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.7.1 /03 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: COEX/PA] - Final report Bayer CropScience, Report No.: 2006-008017-02, Edition Number: M-285849-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.3 /03 ...also filed: KIIIA 2.7.4 /03 ...also filed: KIIIA 2.7.5 /03 KIIIA 2.7.1 /04 2015 Content, colour, odour, physical state, No N Y Bayer surface tension (only before storage) and CropScience suspension before and after storage at elevated temperature of spirotetramat OD 150 (150 g/L) - Packaging material: COEX/PA - Final report (14 days) - 1. Amendment Bayer CropScience, Report No.: FM0222(ACR02)N01, Edition Number: M-514148-02-1 Date: 2015-03-20 ...Amended: 2015-05-06 GLP/GEP: no, unpublished ...also filed: KIIIA 2.5.3 /02 ...also filed: KIIIA 2.8.3.1 /01

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.7.3 /01 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: HDPE] - Final report Bayer CropScience, Report No.: 2006-008017-01, Edition Number: M-285846-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /01 ...also filed: KIIIA 2.7.4 /01 ...also filed: KIIIA 2.7.5 /01 KIIIA 2.7.3 /03 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: COEX/PA] - Final report Bayer CropScience, Report No.: 2006-008017-02, Edition Number: M-285849-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /03 ...also filed: KIIIA 2.7.4 /03 ...also filed: KIIIA 2.7.5 /03

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.7.4 /01 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: HDPE] - Final report Bayer CropScience, Report No.: 2006-008017-01, Edition Number: M-285846-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /01 ...also filed: KIIIA 2.7.3 /01 ...also filed: KIIIA 2.7.5 /01 KIIIA 2.7.4 /03 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: COEX/PA] - Final report Bayer CropScience, Report No.: 2006-008017-02, Edition Number: M-285849-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /03 ...also filed: KIIIA 2.7.3 /03 ...also filed: KIIIA 2.7.5 /03

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.7.5 /01 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: HDPE] - Final report Bayer CropScience, Report No.: 2006-008017-01, Edition Number: M-285846-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /01 ...also filed: KIIIA 2.7.3 /01 ...also filed: KIIIA 2.7.4 /01 KIIIA 2.7.5 /03 2007 Storage stability and shelf life of No N Y Bayer spirotetramat OD 150 (150 g/L) - CropScience [Packaging material: COEX/PA] - Final report Bayer CropScience, Report No.: 2006-008017-02, Edition Number: M-285849-02-1 Date: 2007-02-26 ...Amended: 2009-06-03 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /03 ...also filed: KIIIA 2.7.3 /03 ...also filed: KIIIA 2.7.4 /03

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.8.2 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.8.3.1 /01 2015 Content, colour, odour, physical state, No N Y Bayer surface tension (only before storage) and CropScience suspension before and after storage at elevated temperature of spirotetramat OD 150 (150 g/L) - Packaging material: COEX/PA - Final report (14 days) - 1. Amendment Bayer CropScience, Report No.: FM0222(ACR02)N01, Edition Number: M-514148-02-1 Date: 2015-03-20 ...Amended: 2015-05-06 GLP/GEP: no, unpublished ...also filed: KIIIA 2.5.3 /02 ...also filed: KIIIA 2.7.1 /04

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.8.5.2 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.8.6.1 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.7.5 /01 ...also filed: KIIIA 2.8.8.2 /01

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Annex point / Year Title Data Data Studies relied Owner reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , published Y/N or not KIIIA 2.8.7.5 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.8.2 /01 KIIIA 2.8.8.2 /01 2007 Physical, chemical and technical properties Yes Y Y Bayer of spirotetramat OD 150 G CropScience Bayer CropScience, Report No.: 14 1050 5438, Edition Number: M-285567-01-1 Date: 2007-02-26 GLP/GEP: yes, unpublished ...also filed: KIIIA 2.1 /01 ...also filed: KIIIA 2.4.2 /01 ...also filed: KIIIA 2.5.1 /01 ...also filed: KIIIA 2.5.2 /01 ...also filed: KIIIA 2.5.3 /01 ...also filed: KIIIA 2.6.1 /01 ...also filed: KIIIA 2.8.2 /01 ...also filed: KIIIA 2.8.5.2 /01 ...also filed: KIIIA 2.8.6.1 /01 ...also filed: KIIIA 2.8.7.5 /01

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Analytical methods

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Annex point / Year Title Data Data protection Study relied on Owner reference number Source (where different from company) protect. granted Y/N Company name, Report No., Date, claimed Y/N GLP/GEP status (where relevant) , published or not KIIIA 5.2.1 /01 2013 Determination of spirotetramat in No N Y Bayer formulations ; Assay HPLC, external CropScience standard Bayer CropScience, Report No.: AM023013MF1, Edition Number: M-469691-01-1 Date: 2013-11-14 GLP/GEP: no, unpublished KIIIA 5.2.1 /02 2013 Validation of HPLC-method No N Y Bayer AM023013MF1 - Determination of CropScience spirotetramat in formulations - spirotetramat OD 150 (150 g/L) Bayer CropScience, Report No.: VB2-AM023013MF1, Edition Number: M-472584-01-1 Date: 2013-12-09 GLP/GEP: no, unpublished

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Annex point / Year Title Data Data protection Study relied on Owner reference number Source (where different from company) protect. granted Y/N Company name, Report No., Date, claimed Y/N GLP/GEP status (where relevant) , published or not KIIIA 5.3.1 /01 2012 Validation of the QuEChERS method for the Yes Y Y Bayer determination of selected BCS analytes and CropScience their metabolites in carrot, apple, orange, oilseed rape seed and beans Eurofins Agroscience Services Chem GmbH (EAS Chem), Hamburg, Germany Bayer CropScience, Report No.: 01207, Edition Number: M-424756-01-1 Date: 2012-02-03 GLP/GEP: yes, unpublished

Mass spectra (precursor and product ion spectra) of spirotetramat (BYI08330) and its 2015 metabolites Yes Y Y Bayer (Doc M-519336-01-1) CropScience Date: 30.04.2015

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Annex point / Year Title Data Data protection Study relied on Owner reference number Source (where different from company) protect. granted Y/N Company name, Report No., Date, claimed Y/N GLP/GEP status (where relevant) , published or not KIIIA 5.3.1 /02 2010 Analytical method 01178 for the Yes Y Y Bayer determination of residues of pesticides and CropScience its major metabolites in/on plant material Bayer CropScience, Report No.: 01178, Edition Number: M-386676-01-1 Method Report No.: MR-09/155 Date: 2010-07-15 GLP/GEP: yes, unpublished

Mass spectra (precursor and product ion 2015 spectra) of spirotetramat (BYI08330) and its Yes Y Y Bayer metabolites CropScience (Doc M-519336-01-1) Date: 30.04.2015 KIIIA 5.6 /01 2013 Analytical method 01387 for the Yes Y Y Bayer determination of various pesticides in CropScience drinking and surface water by HPLC- MS/MS Bayer CropScience, Report No.: MR-13/085, Edition Number: M-466732-01-1 Method Report No.: MR-13/085 Date: 2013-10-09 GLP/GEP: yes, unpublished

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KIIIA 5.6 /02 2013 Independent laboratory validation of BCS Yes Y Y Bayer analytical methods 01333 and 01387 for CropScience determination of various pesticides in surface water by Di-HPLC-MS/MS PTRL Europe GmbH, Ulm, Germany Bayer CropScience, Report No.: P3117 G, Edition Number: M-470714-02-1 Date: 2013-12-13 GLP/GEP: yes, unpublished

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Efficacy :

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6 /01 2008 Wirksamkeitsdossier fuer MOVENTO No N Y Bayer - Spirotetramat 150 g/L - Oel- CropScie Dispersion (OD) - BAY-17091-I nce Bayer CropScience Bayer CropScience, Report No.: M-297804-01-1, Edition Number: M-297804-01-1 Date: 2008-02-13 GLP/GEP: no, unpublished KIIIA 6 /02 2008 Biological assessment dossier - No N Y Bayer MOVENTO OTEQ - Spirotetramat CropScie 150 OD nce Bayer CropScience Bayer CropScience, Report No.: M-302766-02-1, Edition Number: M-302766-02-1 Date: 2008-06-30 GLP/GEP: n.a., unpublished KIIIA 6 /03 2011 Summary of the efficacy data and No N Y Bayer information on the plant protection CropScie product for spirotetramat OD 150 (150 nce g/L) Bayer CropScience Bayer CropScience, Report No.: M-418732-01-1, Edition Number: M-418732-01-1 Date: 2011-12-06 GLP/GEP: n.a., unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6 /04 2014 Dokumentacní soubor o biologickém No N Y Bayer hodnocení prípravku na ochranu rostlin CropScie MOVENTO 150 OD (BYI 08330 OD nce 150) - Insekticid do chmelu proti msicím a sviluskám Bayer CropScience Bayer CropScience, Report No.: M-497232-01-1, Edition Number: M-497232-01-1 Date: 2014-05-31 GLP/GEP: n.a., unpublished KIIIA 6 /05 2006 Tier 2 summary of the efficacy data No N Y Bayer and information on the plant protection CropScie product for spirotetramat 150 g/L OD - nce Material no.: 06424376 Bayer CropScience Bayer CropScience, Report No.: M-283054-02-1, Edition Number: M-283054-02-1 Date: 2006-12-29 GLP/GEP: n.a., unpublished KIIIA 6 /06 2014 Summary of the efficacy data and No N Y Bayer information on the plant protection CropScie product for spirotetramat OD150 (150 nce g/L) - Central zone Bayer CropScience Bayer CropScience, Report No.: M-498966-01-1, Edition Number: M-498966-01-1 Date: 2014-10-09 GLP/GEP: n.a., unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6.1 2008 MOVENTO product development: No N Y /01 Custom-made formulations for an exceptional active ingredient Publisher:Bayer CropScience, Pages:141-158, Year:2008, Report No.: M-428875-01-1, Edition Number: M-428875-01-1 GLP/GEP: n.a., published KIIIA 6.1.1 2009 Effect of BYI8330 on the survival, No N Y Bayer /01 fecundity and fertility of Frankliniella CropScie occidentalis nce Bayer CropScience Bayer CropScience, Report No.: M-409705-01-1, Edition Number: M-409705-01-1 Date: 2009-12-15 GLP/GEP: no, unpublished KIIIA 6.1.2 2014 Compilation of trial report for SPT Yes Y Y Bayer /01 OD150 - Spirotetramat OD150 (150 CropScie g/L) - Minimum effective dose trials nce against aphids in lettuce, in the UK Bayer CropScience Bayer CropScience, Report No.: M-497288-01-1, Edition Number: M-497288-01-1 Date: 2014-09-25 GLP/GEP: yes, unpublished KIIIA 6.1.2 2014 Compilation of trial report for SPT Yes Y Y Bayer /02 OD150 - Spirotetramat OD150 (150 CropScie g/L) - Minimum effective dose trials nce against aphids in Lettuce Bayer CropScience Bayer CropScience, Report No.: M-497229-01-1, Edition Number: M-497229-01-1 Date: 2014-09-23 GLP/GEP: yes, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6.1.2 2014 Compilation of trial report for SPT Yes Y Y Bayer /03 SC100 and SPT OD150 - spirotetramat CropScie SC100 (100 g/L); spirotetramat OD150 nce (150 g/L) - Efficacy trials against aphids in potato; plant safety and effects on organs used for propagation Bayer CropScience Bayer CropScience, Report No.: M-492897-01-1, Edition Number: M-492897-01-1 Date: 2014-07-30 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /05 ...also filed: KIIIA 6.2.1 /01 ...also filed: KIIIA 6.2.5 /01 KIIIA 6.1.2 2014 Compilation of trial report for Yes Y Y Bayer /04 spirotetramat SC100 - Minimum CropScie effective dose and efficacy trials on nce onion thrips Thrips tabaci - Maritime climate zone (France) Bayer CropScience Bayer CropScience, Report No.: M-494246-01-1, Edition Number: M-494246-01-1 Date: 2014-08-08 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /01

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6.1.2 2014 Compilation of trial report for SPT SC Yes Y Y Bayer /05 100 / SPT OD 150 - Spirotetramat SC CropScie 100 (100 g/L) - Spirotetramat OD 150 nce (150 g/L) - Efficacy trials - 8 trials (2006-2013) - Thrips Tabaci on brassica crops Bayer CropScience Bayer CropScience, Report No.: M-493538-01-1, Edition Number: M-493538-01-1 Date: 2014-08-06 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /03 KIIIA 6.1.3 2014 Compilation of trial report for Yes Y Y Bayer /01 spirotetramat SC100 - Minimum CropScie effective dose and efficacy trials on nce onion thrips Thrips tabaci - Maritime climate zone (France) Bayer CropScience Bayer CropScience, Report No.: M-494246-01-1, Edition Number: M-494246-01-1 Date: 2014-08-08 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /04 KIIIA 6.1.3 2011 Compilation of trial report for Yes Y Y Bayer /02 MOVENTO - Spirotetramat OD 150 - CropScie Efficacy tests onions nce Bayer CropScience Bayer CropScience, Report No.: M-415781-01-1, Edition Number: M-415781-01-1 Date: 2011-09-20 GLP/GEP: yes, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6.1.3 2014 Compilation of trial report for SPT SC Yes Y Y Bayer /03 100 / SPT OD 150 - Spirotetramat SC CropScie 100 (100 g/L) - Spirotetramat OD 150 nce (150 g/L) - Efficacy trials - 8 trials (2006-2013) - Thrips Tabaci on brassica crops Bayer CropScience Bayer CropScience, Report No.: M-493538-01-1, Edition Number: M-493538-01-1 Date: 2014-08-06 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /05 KIIIA 6.1.3 2014 Compilation of trial report for Yes Y Y Bayer /04 spirotetramat - Efficacy trials on swede CropScie midge Contarinia nasturtii in brassica nce crops - Maritime climate zone Bayer CropScience Bayer CropScience, Report No.: M-492740-02-1, Edition Number: M-492740-02-1 Date: 2014-07-28 GLP/GEP: yes, unpublished KIIIA 6.1.3 2014 Compilation of trial report for SPT Yes Y Y Bayer /05 SC100 and SPT OD150 - spirotetramat CropScie SC100 (100 g/L); spirotetramat OD150 nce (150 g/L) - Efficacy trials against aphids in potato; plant safety and effects on organs used for propagation Bayer CropScience Bayer CropScience, Report No.: M-492897-01-1, Edition Number: M-492897-01-1 Date: 2014-07-30 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /03 ...also filed: KIIIA 6.2.1 /01 ...also filed: KIIIA 6.2.5 /01

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6.1.3 2014 Compilation of trial report for SPT SC Yes Y Y Bayer /06 100 - Spirotetramat SC 100 (100 g/L) - CropScie Efficacy trials - 7 trials (2012-2014) - nce Dasineura tetensis, Cecidophyopsis ribis, Hyperomyzus lactucae and Pseudaulacaspis pentagona on black currant Bayer CropScience Bayer CropScience, Report No.: M-493542-01-1, Edition Number: M-493542-01-1 Date: 2014-08-06 GLP/GEP: yes, unpublished KIIIA 6.1.3 2014 Compilation of trial report for SPT Yes Y Y Bayer /07 SC100 - Spirotetramat SC 100 (100 CropScie g/L) - Efficacy trials in Poland against nce gall mite, aphids and midges in black currant Bayer CropScience Bayer CropScience, Report No.: M-491858-01-1, Edition Number: M-491858-01-1 Date: 2014-07-17 GLP/GEP: yes, unpublished KIIIA 6.1.3 2013 Registration report - Part B - Section 7: No N Y Bayer /08 Efficacy data and information - CropScie Detailed summary - Spirotetramat SC nce 100 (100 g/L) - Central zone - Zonal rapporteur member state: Austria - Core assessment Bayer CropScience Bayer CropScience, Report No.: M-437457-02-1, Edition Number: M-437457-02-1 Date: 2013-05-15 GLP/GEP: n. a., unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 2014 Compilation of trial report for SPT SC Yes Y Y Bayer 6.1.4.1 /01 100 / SPT OD 150 - Spirotetramat SC CropScie 100 (100 g/L) - Spirotetramat OD 150 nce (150 g/L) - Selectivity trials - 4 trials (2012-2013) - Onion and shallot Bayer CropScience Bayer CropScience, Report No.: M-493178-01-1, Edition Number: M-493178-01-1 Date: 2014-08-05 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.3 /01 ...also filed: KIIIA 6.2.1 /02 KIIIA 2014 Compilation of trial report for SPT Yes Y Y Bayer 6.1.4.2 /01 OD150 - Spirotetramat OD150 (150 CropScie g/L) - Taint studies in potatoes nce Bayer CropScience Bayer CropScience, Report No.: M-479818-01-1, Edition Number: M-479818-01-1 Date: 2014-03-07 GLP/GEP: yes, unpublished KIIIA 2014 Compilation of trial report for SPT Yes Y Y Bayer 6.1.4.2 /02 SC100 - Spirotetramat SC100 (100 CropScie g/L) - Taint studies in spinach nce Bayer CropScience Bayer CropScience, Report No.: M-479816-01-1, Edition Number: M-479816-01-1 Date: 2014-03-07 GLP/GEP: yes, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 2014 Compilation of trial report for SPT Yes Y Y Bayer 6.1.4.2 /03 SC100 - Spirotetramat SC100 (100 CropScie g/L) - Taint studies in onion nce Bayer CropScience Bayer CropScience, Report No.: M-479815-01-1, Edition Number: M-479815-01-1 Date: 2014-03-07 GLP/GEP: yes, unpublished KIIIA 2014 Compilation of trial report for SPT Yes Y Y Bayer 6.1.4.2 /04 SC100 - Spirotetramat SC100 (100 CropScie g/L) - Taint studies in strawberry nce Bayer CropScience Bayer CropScience, Report No.: M-479812-01-1, Edition Number: M-479812-01-1 Date: 2014-03-07 GLP/GEP: yes, unpublished KIIIA 2014 Compilation of trial report for SPT Yes Y Y Bayer 6.1.4.2 /05 SC100 - Spirotetramat SC100 (100 CropScie g/L) - Taint studies in black currant nce Bayer CropScience Bayer CropScience, Report No.: M-483940-01-1, Edition Number: M-483940-01-1 Date: 2014-04-16 GL P/GEP: yes, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 2011 Sensory evaluation of lettuce treated Yes Y Y Bayer 6.1.4.2 /06 with spec 102000016434 (a.i. CropScie spirotetramat) - Client trial ref. nos: nce s10-01155-01, s10-01155-02, s10- 01155-03 Campden Technology Limited, Gloucestershire, United Kingdom Bayer CropScience, Report No.: S/REP/119910/14, Edition Number: M-428517-01-1 Date: 2011-03-30 GLP/GEP: yes, unpublished KIIIA 2011 Final report on project S10-01155 - Yes Y Y Bayer 6.1.4.2 /07 Field study to generate specimens of CropScie field and protected lettuce treated with nce spec 102000016434 and spec 102000021884, 2 sites in the UK and 1 site in spain for subsequent triangle taint test, 2010 Eurofins Agroscience Services Ltd., Derbyshire, United Kingdom Bayer CropScience, Report No.: M-428514-01-1, Edition Number: M-428514-01-1 Date: 2011-06-03 GLP/GEP: yes, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 2014 Compilation of trial report for SPT SC Yes Y Y Bayer 6.1.4.3 /01 100 / SPT OD 150 - Spirotetramat SC CropScie 100 (100 g/L) - Spirotetramat OD 150 nce (150 g/L) - Selectivity trials - 4 trials (2012-2013) - Onion and shallot Bayer CropScience Bayer CropScience, Report No.: M-493178-01-1, Edition Number: M-493178-01-1 Date: 2014-08-05 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.1 /01 ...also filed: KIIIA 6.2.1 /02 KIIIA 6.2.1 2014 Compilation of trial report for SPT Yes Y Y Bayer /01 SC100 and SPT OD150 - spirotetramat CropScie SC100 (100 g/L); spirotetramat OD150 nce (150 g/L) - Efficacy trials against aphids in potato; plant safety and effects on organs used for propagation Bayer CropScience Bayer CropScience, Report No.: M-492897-01-1, Edition Number: M-492897-01-1 Date: 2014-07-30 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /03 ...also filed: KIIIA 6.1.3 /05 ...also filed: KIIIA 6.2.5 /01

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Annex Year Title Data Data Studies Owner point / Source (where different from protect. protectio relied on reference company) Claimed n Y/N number Company name, Report No., Date, Y/N granted GLP/GEP status (where relevant), Y/N published or not KIIIA 6.2.1 2014 Compilation of trial report for SPT SC Yes Y Y Bayer /02 100 / SPT OD 150 - Spirotetramat SC CropScie 100 (100 g/L) - Spirotetramat OD 150 nce (150 g/L) - Selectivity trials - 4 trials (2012-2013) - Onion and shallot Bayer CropScience Bayer CropScience, Report No.: M-493178-01-1, Edition Number: M-493178-01-1 Date: 2014-08-05 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.1 /01 ...also filed: KIIIA 6.1.4.3 /01 KIIIA 6.2.5 2014 Compilation of trial report for SPT Yes Y Y Bayer /01 SC100 and SPT OD150 - spirotetramat CropScie SC100 (100 g/L); spirotetramat OD150 nce (150 g/L) - Efficacy trials against aphids in potato; plant safety and effects on organs used for propagation Bayer CropScience Bayer CropScience, Report No.: M-492897-01-1, Edition Number: M-492897-01-1 Date: 2014-07-30 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /03 ...also filed: KIIIA 6.1.3 /05 ...also filed: KIIIA 6.2.1 /01

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Mammalian toxicology

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Annex point / Year Title Data Data rotection Studies relied Owner reference number Source (where different from company) protect. granted on Company name, Report No., Date, claimed Y/N Y/N GLP/GEP status (where relevant) , published or not KIIIA 7.1.1 /01 2007 Spirotetramat OD 150 (Project: Yes Y Y Bayer Spirotetramat (BYI 08330)) - Acute toxicity CropScience in the rat after oral administration Report No.: AT03591, Edition Number: M-282734-01-1 Date: 2007-01-12 GLP/GEP: yes, unpublished KIIIA 7.1.2 /01 2007 Spirotetramat OD 150 (Project: Yes Y Y Bayer Spirotetramat (BYI 08330)) - Acute toxicity CropScience in the rat after dermal application Report No.: AT03592, Edition Number: M-282738-01-1 Date: 2007-01-12 GLP/GEP: yes, unpublished KIIIA 7.1.3 /01 2007 Spirotetramat OD 150 - Acute inhalation Yes Y Y Bayer toxicity in rats CropScience Report No.: AT03635, Edition Number: M-283293-01-1 Date: 2007-02-01 GLP/GEP: yes, unpublished KIIIA 7.1.4 /01 2007 Spirotetramat OD 150 - Acute skin Yes Y Y Bayer irritation/corrosion on rabbits CropScience Report No.: AT03613, Edition Number: M-282984-01-1 Date: 2007-01-26 GLP/GEP: yes, unpublished KIIIA 7.1.5 /01 2007 Spirotetramat OD 150 - Acute eye irritation Yes Y Y Bayer on rabbits CropScience Report No.: AT03616, Edition Number: M-282977-01-1 Date: 2007-01-26 GLP/GEP: yes, unpublished

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Metabolism and Residues

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Annex point / Year Title Data Studies relied on Data protect. Owner reference number Source (where different from company) protect. Y/N granted Company name, Report No., Date, GLP/GEP claimed status (where relevant) , published or not KIIIA 8.3.6/01 2015 Determination of the residues of BYI 08330 in/on Yes Yes Yes Bayer CropScience strawberry after spraying of spirotetramat SC 100 in the field in Germany, the Netherlands, Belgium and France (north) Report no. 14-2133, including trial 14-2133-01 to -04 Edition No: M-537237-01-1 GLP yes, unpublished KIIIA 8.3.6/02 2015 Determination of the residues of BYI 08330 in/on Yes Yes Yes Bayer CropScience strawberry after spray application of Spirotetramat SC 100 in Germany and Poland Report no. 14-2179, including trial 14-2179 -01 and -02 Edition No: M -539172 -01 KIIIA 8.3.7. /01 2013 Determination of the residues of spirotetramat Yes Yes Yes Bayer CropScience in/on red currant after spray application of spirotetramat SC 100 in the Netherlands Bayer CropScience, Report No.: 12-2127, Report includes Trial Nos.: 12-2127-01 Edition Number: M-473240-01-1 Date: 2013-12-11 GLP/GEP: yes, unpublished KIIIA 8.3.7. /02 2012 Residues of spirotetramat in red currant under Yes Yes Yes Bayer CropScience plastic umbrella at intervals following two foliar applications of spriotetramat 100 SC - Belgium, season 2011 Redebel S.A., Saint Amand, Belgium Bayer CropScience, Report No.: BCS-G403-11, Edition Number: M-433729-01-1 Date: 2012-05-15 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Studies relied on Data protect. Owner reference number Source (where different from company) protect. Y/N granted Company name, Report No., Date, GLP/GEP claimed status (where relevant) , published or not KIIIA 8.3.8. /01 2005 Determination of the residues of BYI 08330 in/on Yes Yes Yes Bayer CropScience potato after spraying of BYI 08330 (100 OD) in the field in Germany, Northern France and United Kingdom Bayer CropScience, Report No.: RA-2114/04, Report includes Trial Nos.: 0690-04 0691-04 0692-04 0693-04 R 2004 0690/8 R 2004 0691/6 R 2004 0692/4 R 2004 0693/2 Edition Number: M-259808-01-1 Date: 2005-11-03 GLP/GEP: yes, unpublished KIIIA 8.3.8 /02 2014 Determination of the residues of spirotetramat Yes Yes Yes Bayer CropScience in/on potato after spray application of spirotetramat SC 100 in the field in Germany, United Kingdom and Belgium Bayer CropScience, Report No.: 12-2128, Report includes Trial Nos.: 12-2128-01 12-2128-02 12-2128-03 12-2128-04 Edition Number: M-481503-01-1 Date: 2014-03-27 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Studies relied on Data protect. Owner reference number Source (where different from company) protect. Y/N granted Company name, Report No., Date, GLP/GEP claimed status (where relevant) , published or not 8.3.15/01 2014 Determination of residues of spirotetramat and Yes Yes Yes Bayer CropScience metabolites in vegetables: MOVENTO OD 150 in/on lettuce Report No.: P 3060 G, Report includes Trial Nos.: LR-G-13-BG-I-03-BON-01 LR-G-13-BG-I-03-BON-02 LR-G-13-BG-I-03-SCH-01 LR-G-13-BG-I-03-WET-01 Edition Number: M-496901-02-1 Date: 2014-12-18 GLP/GEP: yes, unpublished 8.3.15/02 2015 Determination of the residues of BYI 08330 in/on Yes Yes Yes Bayer CropScience lettuce after spraying of spirotetramat SC 100 in the field in Germany and Belgium Report No.: 14-2124, Report includes Trial Nos.: 14-2124-01 and 14-2124-02 Edition Number: M-537039-01-1 Date: 2015-10-22 GLP/GEP: yes, unpublished KIIIA 8.3.17 /01 2009 Determination of the residues of BYI 08330 in/on Yes Yes Yes Bayer CropScience chicory, witloof after spraying of BYI 08330 (100 SC) in the field in Belgium and Germany Bayer CropScience, Report No.: RA-2014/07, Report includes Trial Nos.: R 2007 0308/2 = 0308 - 07 R 2007 0309/0 = 0309 - 07 Edition Number: M-343962-01-1 Date: 2009-03-13 GLP/GEP: yes, unpublished

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Ecotoxicology

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Annex point / Year Title Data Owner Study used for Dataprotection reference Source (where different from company) protect. evaluation granted number Company name, Report No., Date, claimed Yes/No GLP/GEP status (where relevant) , published or not KIIIA 10.1.2 2014 Spirotetramat OD 150 G - Higher tier risk No Bayer CropScience Yes N /01 assessment for birds (long-term) (uses in the Central zone) Bayer CropScience, Report No.: M-494693-01-1, Edition Number: M-494693-01-1 Date: 2014-08-20 GLP/GEP: n.a., unpublished KIIIA 10.1.7 2007 Generic field monitoring of selected bird Yes BASF Yes N /04 species in orchards in Southern Germany BASF AG, Limburgerhof, Germany BASF, Report No.: 218044, Edition Number: M-291211-01-1 Date: 2007-04-23 GLP/GEP: yes, unpublished KIIIA 10.1.7 2012 Residues of spirotetramat in arthropods Yes Bayer CropScience Yes N /06 after spray application in pome fruit orchards in the Netherlands - Magnitude and time course of residue decline Bayer CropScience, Report No.: BAR/FS63, Edition Number: M-429384-01-1 Date: 2012-04-02 GLP/GEP: yes, unpublished KIIIA 10.1.7 2004 Generic field monitoring of birds and Yes Bayer CropScience Yes N /07 mammals in hop-cultivation in Southern Germany Bayer CropScience, Report No.: WFC/FS 009, Edition Number: M-123479-01-1 Date: 2004-11-12 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Study used for Dataprotection reference Source (where different from company) protect. evaluation granted number Company name, Report No., Date, claimed Yes/No GLP/GEP status (where relevant) , published or not KIIIA 10.1.7 2008 Generic monitoring of birds in vegetable No Syngenta Yes N /08 fields in Great Britain RifCon GmbH, Hirschberg, Germany Syngenta, Report No.: R07-034, Edition Number: M-302416-01-1 Date: 2008-06-02 GLP/GEP: yes, unpublished KIIIA 10.1.7 2004 Generic field monitoring of birds in Yes Bayer CropScience Yes N /10 potato cultivation in northern Germany Bayer CropScience, Report No.: WFC/FS 019, Edition Number: M-090336-02-1 Date: 2004-09-29 ...Amended: 2005-01-04 GLP/GEP: yes, unpublished KIIIA 10.1.7 2014 Expert statement - Frugivorous birds in No Bayer CropScience Yes N /11 vineyards in Europe RIFCon GmbH, Hirschberg, Germany Bayer CropScience, Report No.: R14153, Edition Number: M-485363-01-1 Date: 2014-05-07 GLP/GEP: n.a., unpublished KIIIA 10.1.7 2007 Bird species in cauliflower fields in No Syngenta Yes N /12 Brittany (northern France): field data for the determination of focal species RifCon GmbH, Hirschberg, Germany Syngenta, Report No.: RA05-225/5, Edition Number: M-291770-01-1 Date: 2007-01-16 GLP/GEP: no, unpublished

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Annex point / Year Title Data Owner Study used for Dataprotection reference Source (where different from company) protect. evaluation granted number Company name, Report No., Date, claimed Yes/No GLP/GEP status (where relevant) , published or not KIIIA 10.1.7 2007 Bird species in lettuce fields in Brittany No Syngenta Yes N /14 (northern France): field data for the determination of focal species RifCon GmbH, Hirschberg, Germany Syngenta, Report No.: RA05-225/3, Edition Number: M-291775-01-1 Date: 2007-01-16 GLP/GEP: no, unpublished KIIIA 10.1.7 2010 Determination of the residues of Yes Bayer CropScience Yes Y /16 spirotetramat in/on field samples of plant origin after spray application with MOVENTO Bayer CropScience, Report No.: MR-09/008, Edition Number: M-361589-02-1 Date: 2010-01-13 ...Amended: 2010-03-23 GLP/GEP: yes, unpublished KIIIA 10.2.2.2 2007 Acute toxicity of BYI 08330 OD 150 Yes Bayer CropScience Yes N /02 new to larvae of Chironomus riparius in a 48 h static laboratory test system Bayer CropScience, Report No.: DOM 26019, Edition Number: M-283498-01-1 Date: 2007-02-08 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Study used for Dataprotection reference Source (where different from company) protect. evaluation granted number Company name, Report No., Date, claimed Yes/No GLP/GEP status (where relevant) , published or not KIIIA 10.4.5 2012 A multi-rate field study to evaluate Yes Bayer CropScience Yes Y /02 potential effects on honeybees Apis mellifera L. (Hymenoptera: Apidae) following an application of spirotetramat OD 150B G during bee-flight on Phacelia tanacetifolia Innovative Environmental Services (IES) Ltd., Witterswil, Switzerland Bayer CropScience, Report No.: 20110058, Edition Number: M-439646-01-1 Date: 2012-10-11 GLP/GEP: yes, unpublished KIIIA 10.4.7 2009 Effects of Spirotetramat OD 150 No Bayer CropScience Yes N /02 (MOVENTO) on honeybees in a greenhouse trial in strawberries in Germany Bayer CropScience, Report No.: SBJ-H9-2009, Report includes Trial Nos.: IA09DVG006K610 Edition Number: M-354707-01-1 Date: 2009-09-01 GL P/GEP: no, unpublished

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Annex point / Year Title Data Owner Study used for Dataprotection reference Source (where different from company) protect. evaluation granted number Company name, Report No., Date, claimed Yes/No GLP/GEP status (where relevant) , published or not KIIIA 10.4.7 2010 Effects of an application of Spirotetramat Yes Bayer CropScience Yes N /03 SC 100 to flowering raspberries on honeybee (Apis mellifera) brood in a semi-field study The Food and Environment Research Agency FERA, Sand Hutton, York, Y041 1LZ, Great Britain Bayer CropScience, Report No.: S3XZ1000, Edition Number: M-369450-01-1 Date: 2010-05-20 GLP/GEP: yes, unpublished KIIIA 10.5.3 2014 Toxicity to the predatory mite Yes Bayer CropScience Yes Y /01 Typhlodromus pyri (Acari: Phytoseiidae) using an extended laboratory test with aged residues on apple Spirotetramat OD 150 g/L Bayer CropScience, Report No.: CW13/036, Edition Number: M-477752-01-1 Date: 2014-01-30 GLP/GEP: yes, unpublished KIIIA 10.6.3 2014 Spirotetramat OD 150 G: Effects on Yes Bayer CropScience Yes Y /01 reproduction and growth of earthworms eisenia fetida in artificial soil IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 86933022, Edition Number: M-478321-01-1 Date: 2014-02-04 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Study used for Dataprotection reference Source (where different from company) protect. evaluation granted number Company name, Report No., Date, claimed Yes/No GLP/GEP status (where relevant) , published or not KIIIA 10.6.6 2014 Spirotetramat OD 150 G: Effects on Yes Bayer CropScience Yes Y /01 reproduction of the Collembola folsomia candida in artificial soil IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 86931016, Edition Number: M-484722-01-1 Date: 2014-04-29 GLP/GEP: yes, unpublished KIIIA 10.6.6 2014 1st final report amendment - Yes Bayer CropScience Yes Y /02 Spirotetramat OD 150 G: Effects on reproduction of the predatory mite Hypoaspis aculeifer in artificial soil IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 86932089, Edition Number: M-478635-02-1 Date: 2014-02-20 ...Amended: 2014-03-10 GLP/GEP: yes, unpublished KIIIA 10.7.1 2014 Spirotetramat OD 150 G: Effects on the Yes Bayer CropScience Yes Y /01 activity of soil microflora (nitrogen transformation test) BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 14 10 48 017 N, Edition Number: M-484256-01-1 Date: 2014-04-15 GLP/GEP: yes, unpublished

Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL Date: October 2018