REGISTRATION REPORT Part A

Home , Hyperomyzus, Phyllaphis, Uroleucon sonchi

Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 1 of 117

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT Op 10 juli 2013 is van

Bayer CropScience S.A.-N.V. Postbus 231 3640 AE MIJDRECHT een aanvraag tot uitbreiding van een toelating van een gewasbeschermingsmiddel (NL is CMS) ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel

Batavia 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.

HET COLLEGE BESLUIT tot uitbreiding van de toelating van bovenstaand middel.

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.

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. Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 2 of 117

° 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) Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. De te hanteren w-coderingen en aflever- en opgebruiktermijnen voor oude verpakkingen staan vermeld onder “toelatingsinformatie” in bijlage I.

2. WETTELIJKE GRONDSLAG Besluit artikel 33 en artikel 36, derde lid, van de Verordening (EG) 1107/2009 Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Bgb en Rgb d.d. 16 december 2011, Evaluation Manual Zonaal

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.

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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, 5 oktober 2018

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

Ir. J.F. de Leeuw Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 4 of 117

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20131028 NLWTG Type aanvraag: Aanvraag tot uitbreiding van toelating gewasbeschermingsmiddel (NL is CMS) Middelnaam: Batavia Verzenddatum aanvraag: 8 juli 2013 Formele registratiedatum: * 10 juli 2013 Datum in behandeling name: 25 november 2016 Datum compliance check: n.v.t.

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

2.2 Stofinformatie

Werkzame stof Gehalte spirotetramat 100 g/L

• De stof is per 1 mei 2014 goedgekeurd krachtens Verordening (EG) 1107/2009 (Uitvoeringsverordening (EG) 1177/2013 d.d. 20 november 2013). De goedkeuring van deze werkzame stof expireert op 30 april 2024.

2.3 Toelatingsinformatie

Toelatingsnummer: 15615 N Expiratiedatum: 30 april 2025 Afgeleide parallel of origineel: Uitbreiding Middel Biocide , gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel Gebruikers: Professioneel

W-coderingen en aflever- en opgebruiktermijnen: ° W-codering professioneel gebruik: W1 ° Vorige w -codering professioneel gebruik: - ° Aflevertermijn professioneel gebruik: Niet van toepassing ° Opgebruiktermijn professioneel gebruik: Niet van toepassing

2.4 Verpakkingsinformatie

Aard van het preparaat: Suspensie concentraat

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel Batavia

Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: spirotetramat Pictogram GHS07 GHS08 GHS09 Signaalwoord Waarschuwing Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken. 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. P333 + P313 Bij huidirritatie of uitslag: een 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 code: 102000016538 Product name Batavia Active Substance: Spirotetramat SC 100 (100 g/L)

Country: The Netherlands Central zone Zonal Rapporteur Member State: Austria

NATIONAL ASSESSMENT

Applicant: Bayer CropScience Date: September 2018

Evaluator: Ctgb, NL

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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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PART A – Risk Management This document describes the acceptable use conditions required for the extension of the authorisation of Batavia (Spirotetramat SC 100 G) 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 Spirotetramat SC 100 G where that data has not been considered in the EU review. Otherwise assessments for the safe use of Spirotetramat SC 100 G 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 extension of the authorisation of Batavia.

Appendix 1 of this document provides 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 of this document provides a list of data in support of the evaluation.

1 Details of the application

1.1 Application background This application was submitted by Bayer CropScience SA-NV in 2013 (20131028 NLTG). Austria was de zRMS for Batavia (Spirotetramat SC 100 G) (previous Movento SC).

The application was for extension of the authorisation of Batavia, a suspension concentrate containing 100 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.

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1.3 Regulatory approach To obtain authorization of the product Batavia, 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.

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-authorisation 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.

Batavia was not the representative formulation for the the inclusion of spirotetramat into the Annex to Implementing Regulation (EU) No. 540/2011. 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.

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2 Details of the authorisation

2.1 Product identity

Product Name Tradename: Batavia Spirotetramat SC 100 G (100 g/L) Specification n°102000016538-02 Authorisation Number Not applicable (for re-registration) Function Insecticide, acaricide Applicant Bayer CropScience SA-NV Composition 100 g/L spirotetramat Formulation type Suspension Concentrate [Code: SC] Packaging Size : 1 - 10 L Material : HDPE, Coex HDPE/EVOH. Screw cap Cobra 50 mm, Glostar 63 mm (with HF seal or internal wad) - to fit container neck as defined in ECPA One Trip Container Guidelines. Tri – Sure, S 56 x 4 mm, guarantees closure. Screw cap DN 50 guarantees closure and DN 150 guarantees closure.

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 reaction. 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 protection/face protection. P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P501 Dispose of contents/container to … Supplemental Hazard EUH401 To avoid risks to human health and the information: environment, com ply with the instructions 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: Proposal made by the applicant is accepted.

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Other: - * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

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2.3 Authorised uses

F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

14 NLD Apple F Aphis spp. L. Spraying BBCH 69-81 1 - 2 14 days 0.015- 500 – 0.075- 21 75 g a.i./mCH = 0.15% C zone 0.015 1200 0.18 (Rhopalosiphum May-sep insertum, Dysaphis devecta and D. anthrisci, Dysaphis plantaginea, Aphis pomi)

15 NLD Apple F Eriosoma lanigerum Spraying BBCH 69-81 1 - 2 14 days 0.015 - 500 - 0.075 - 21 75 g a.s. / ha / mCH* C zone 0.015 1200 0.18 May-sep max 3 m

0.15%

16 NLD Pear F Aphis spp. L. Spraying BBCH 69-81 1 - 2 14 days 0.015- 500 – 0.075- 21 75 g a.i./mCH = 0.15% C zone 0.015 1200 0.18 (Rhopalosiphum May-sep insertum, Aphis pomi, Dysaphis pyri, Anuraphis farfarae, Melanaphis pyaria )

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

17 NLD Pear F Psylla piri Spraying BBCH 69-81 1 - 2 14 days 0.015 - 500 - 0.075 - 21 max 3 m C zone 0.015 1200 0.18 May-sep 0.15%

29 NLD Cherry F Aphis sp. L. Spraying BBCH 69-81 1 - 2 14 days 0.0075 - 500 - 0.0375- 21 Minor use C zone 0.0075 1500 0.1125 (Myzus cerasi) May-aug 37,5 g a.s. / ha / mCH*

max 3 m

0.075%

30 NLD Plum F Aphis spp. L. Spraying BBCH 69-81 1 - 2 14 days 0.0075 - 500 - 0.0375- 21 Minor use C zone 0.0075 1500 0.1125 (Brachycaudus May-aug 37,5 g a.s. / ha / mCH* helichrysi, Hyalopterus max 3 m amygdali, Hyalopterus pruni) 0.075%

34 NLD Grape, European F Aphis sp. L. Spraying BBCH 69-81 1 - 2 14 days 0.0075 - 400 - 0.03 - 14 Minor use C zone (Myzus persicae) May-sep 0.0075 1000 0.075

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

35 NLD Blackberry and F Aphis spp. L. Spraying Post harvest 1 - 2 14 days 0.0063 - 1000 - 0.075 - n.a. Minor use C zone raspberry family Eriophyidae BBCH 91 – 92 0.0075 1200 0.075 (Rubus spp.) (Brachycaudus Jun-Nov prunicola, Hyperomyzus lactucae, Amphorophora idaei, Sitobion fragariae, Amphorophora rubi, Rhopalosiphoninus ribesinus, Aphis idaei, Aphis ruborum)

48 NLD Lettuce ( Lactuca F Pemphigus bursarius Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 3 crop cycles /year, only 2 C zone spp.) LACSS LINNAEUS 0.0375 800 0.075 applications per 12 months April-Oct allowed. Aphis spp. L.

(Nasanovia ribisnigri, Myzus persicae, Aphis gossypii, Uroleucon sonchi)

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

NLD Endive CICEN F Aphis spp. L. Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 3 crop cycles /year, only 2 C zone 0.0375 800 0.075 applications per 12 months (Nasanovia allowed. ribisnigri, Myzus persicae, Aphis gossypii, Uroleucon sonchi)

NLD Lamb’s lettuce Aphis spp. L. Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 3 crop cycles /year, only 2 C zone VLLLO 0.0375 800 0.075 applications per 12 months (Nasanovia allowed. ribisnigri, Myzus persicae, Aphis gossypii, Uroleucon sonchi)

53 NLD Spinach SPQOL F Aphis spp. L. Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 2 crop cycles /year only 2 C zone 0.0375 800 0.075 applications per 12 months (Nasanovia April-Oct allowed. ribisnigri, Myzus persicae, Aphis gossypii, Uroleucon sonchi)

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

NLD Rocket ERUVE F Aphis spp. L. Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 Minor use C zone (Nasanovia 0.0375 800 0.075 ribisnigri, Myzus April-Oct 2 applications per 12 months persicae, Aphis allowed. gossypii, Uroleucon sonchi)

NLD Vegetable sprouts F Aphis spp. L. Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 Minor use C zone (Nasanovia 0.0375 800 0.075 ribisnigri, Myzus April-Oct 2 applications per 12 months persicae, Aphis allowed. gossypii, Uroleucon sonchi)

NLD Baby leaf crops F Aphis spp. L. Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 Minor use C zone (Nasanovia 0.0375 800 0.075 ribisnigri, Myzus April-Oct 2 applications per 12 months persicae, Aphis allowed. gossypii, Uroleucon sonchi)

57 NLD Aromatic and F Aphis spp. L. Spraying BBCH 12-48 1 - 2 14 days 0.0094 - 200 - 0.075 - 7 Minor use C zone medical herbs (Myzus persicae, April-Oct 0.0375 800 0.075 Consumption of stems and/or Aphis gossypii, leaves Uroleucon sonchi, Nasonovia ribinigri)

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

66 NLD Flower bulb and F Aphis spp. L. Spraying BBCH 69-89 1 - 4 14 days 0.0188 - 150-400 0.075 - n.a. 4 applications per 12 months C zone flower tuber crops 0.05 0.075 (Dysaphis anthrisci , April-sept Myzus persicae, Aphis gossypii, Aphis Fabae, Macrosiphum euphorbiae, Aulacorthum solani)

74 NLD Perennial crops F Aphis spp. L. Spraying At 1 - 2 14 days 0.0075 - 300 - 0.0225 - 2 applications per 12 months C zone infection/infesta 0.0075 1000 0.075 (Myzus persicae, tion 0.075% Aphis gossypii, Aphis BBCH 69-89 Fabae, Macrosiphum Mar-sep euphorbiae, Aulacorthum solani, Rhodobium porrosum)

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

75 NLD Ornamental crops F Aphis spp. L. Spraying At 1 - 2 14 days 0.0075 - 300 - 0.0225 - 2 applications per 12 months C zone infection/infesta 0.0075 1000 0.075 (Myzus persicae, tion 0.075% Aphis gossypii, Aphis BBCH 69-89 Fabae, Macrosiphum Jun-oct euphorbiae, Aulacorthum solani, Dysaphis anthrisci)

80 NLD Tree nursery crops F Aphidina Spraying Mar-Sept 1 - 2 14 days 0.0075 - 250 - 0.0187 - 2 applications per 12 months C zone 0.0075 1200 0.09 (Myzus persicae, After 0.075% Aphis gossypii, Aphis appearance of Fabae, symptoms Macrosiphum BBCH 69-89 euphorbiae, Aulacorthum solani, Dysaphis anthrisci)

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

NLD Strawberry F Aphis sp. L. Foliar BBCH49 - 1 - 2 14 days 0.0063 - 200 - 0.075 n.a. No application possible less C zone FRAAN (Macrosiphum spraying Several 0.0375 1200 than 14 days before flowering, euphorbiae, daughter plants during flowering and until last Aulacorthum solani, with roots harvest. BBCH56 - Aphis fabae, Myzus Inflorescence persicae, elongating Hyperomyzus lactucae, Nasanovia ribisnigri,Amphorop hora idaei, Chaetosiphon fragaefolii, Aphis gossypii, Myzus ascalonicus ) NLD Strawberry F Aphis sp. L. Foliar BBCH93 - Old 1 - 2 14 days 0.0063 - 200 - 0.075 n.a. Post harvest C zone FRAAN (Macrosiphum spraying leaves dying, 0.0375 1200 euphorbiae, young leaves Aulacorthum solani, curling BBCH97 - Old Aphis fabae, Myzus leaves dead persicae, Hyperomyzus May-sep lactucae, Nasanovia ribisnigri, Amphorophora idaei, Chaetosiphon fragaefolii, Aphis gossypii, Myzus ascalonicus )

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F Pests or Crop and/or G PHI Use Country Group of pests Remarks: situation or Application Application rate per treatment (days) No. Zone controlled (m) (a) I (l) (c) (b)

Numbe Growth Interval kg as/ha (*) Method r kg as/hL water currently stage & between kind min L/ha authorized season applica- min (f-h) max min max min max use (j) tions (min) max (k)

NLD Potato F Aphis sp. L. Foliar BBCH69 - End 1 - 4 7 days 0.0188 - 150 - 0.075 14 After flowering – No flowers C zone SOLTU (Macrosiphum spraying of flowering 0.05 400 present euphorbiae, BBCH95 Aphis nasturtii, July-sept Aphis frangulae, Aulacorthum solani, Aphis fabae ) NLD Onion F Thrips tabaci Foliar BBCH13 - 3rd 1 - 4 7 days 0.0188 - 150 - 0.075 7 C zone ALLCE THRITB spraying leaf (>3 cm) 0.05 400 visible BBCH47 - Bolting begins; in 10% leaves bent over APR-OCT NLD Shallots ALLAS F Thrips tabaci Foliar BBCH13 - 3rd 1 - 4 7 days 0.0188 - 150 - 0.075 7 Minor use C zone THRITB spraying leaf (>3 cm) 0.05 400 visible BBCH47 - Bolting begins; in 10% leaves bent over APR-OCT

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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: Batavia is a suspension concentrate containing 100 g/L spirotetramat. Its appearance is that of a white suspension with a weak paint-like/musty odour. It is not explosive. It has no oxidizing properties. It has a flash point > 100 °C and an auto ignition temperature of 440 °C. The kinematic viscosity at 40˚C is 9.26 mm 2/s with an hydrocarbon content << 10%. The neat preparation has a surface tension of 34 mN/m and a 0.1% dilution 43 mN/m and should be regarded as being a surface active material. The relative density is 1.077. The pH of a 1% dilution is 4.2. Its stability tested at low, ambient and elevated temperatures allows storage under practical and commercial conditions in HDPE and coex- HDPE/EVOH. Therefore a 2 year shelf-life in HDPE and coex-HDPE/EVOH is granted. 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 a suspension concentrate.

Implications for labelling: None

Compliance with FAO guidelines: The product Batavia 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 Batavia.

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 Batavia 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, the relevant impurities of spirotetramat and relevance of CIPAC methods in Batavia 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 in matrices of plant origin and in water have been developed and provided. All data are considered adequate.

The analytical method for the determination of spirotetramat and spirotetramat-enol in surface water is compliant with Dutch national requirements (LOQ ≤ 0.1 µg/L for spirotetramat and spirotetramat-enol)

Applicant: Bayer CropScience Evaluator: NL, Ctgb Date: November 2016 Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 22 of 117

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

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) Spirotetramat SC 100 (100 g/L) is of low acute toxicity by the oral, dermal and inhalation routes of exposure in Wistar rats. Spirotetramat SC 100 (100 g/L) is not irritating when applied to the skin and eyes of New Zealand White rabbits. Spirotetramat SC 100 (100 g/L) is positive for skin sensitization using the Buehler Patch test.

Acute toxicity date obtained with Batavia Type of study Results Classification

Acute oral rat LD 50 : >2000 mg/kg bw None

Acute dermal rat LD 50 : >2000 mg/kg bw None

Acute inhalation rat LC 50 : >2801 mg/m³ air None (maximum techn. feasible concentration) Acute skin irritation rabbit Not irritating None Acute eye irritation rabbit Not irritating None Skin sensitisation (Buehler Patch Sensitising Skin Sens 1, H317 Test in guinea pigs)

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) A dermal absorption study was performed with the SC 100 formulation in vitro using human skin. As a result of the study the following dermal absorption values are used in the risk assessment: 0.1% for the concentrate and 11% for the spray dilutions. 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.

According to the model calculations presented in the core section by zRMS Austria, it can be concluded that: • For the upward airblast use: based on the critical EU-GAP using UK-POEM (application rate of.0.225 kg a.s./ha applied with 700 L water per hectare) the highest estimated exposure is 146% of the AOEL without the use of PPE and 104% with the use of PPE (gloves during mixing/loading and application). Using the German model, for this application the estimated exposure is 66% of the AOEL without the use of PPE. The zRMS AT states that although a slight exceedance of the AOEL (104%) is observed for protected operators based on UK-POEM, the German Model indicates a safe use also for unprotected airblast operators and therefore an overall conclusion is made that the use of Batavia does not result in an unacceptable risk for operators. According to zRMS as presented in the core section the above scenario also covers applications to grape (0.075 kg a.s./ha and 1000 L/ha) and currant (0.075 kg a.s./ha and 200 L/ha). However, the critical NL-GAP slightly differs from the evaluated critical EU-GAP in the core assessment due to a lower spray volume and a lower dose rate (500 L water/ha and 0.18 kg a.s./ha, respectively). This affects the assessments using UK-POEM, but not for the German model. The re-calculations presented in the national addendum show an estimated exposure of 164% of the AOEL without the use of PPE and 116% with the use of PPE (gloves during mixing/loading and application). However, the zRMS AT relies on

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the exposure assessments for the operator using the German model. Further, UK POEM assumes a treated area per day of 15 hectares for upward spraying, whereas the DE model assumes an area of 8 hectares. In the Netherlands, we also assume a treated area of 8 hectares for mechanical upward spraying. Therefore, the estimation based on the DE model seems most appropriate and the overall conclusion by AT is followed that the use of Batavia does not result in an unacceptable risk for operators. • For the upward hand-held use : based on the critical EU-GAP (0.225 kg a.s./ha) using the German model the estimated exposure is 32% of the AOEL without the use of PPE. Calculations for hand-held spraying in high crops are not supported by the UK-POEM. These are therefore only conducted with the German Model. • For the downward boom-sprayer use : based on the critical EU-GAP using UK-POEM (0.100 kg a.s./ha and 200 L water per hectare) the estimated exposure is 78% of the AOEL without the use of PPE. Using the German model, for this application the estimated exposure is 13% of the AOEL without the use of PPE. The critical NL-GAP slightly differs from the evaluated critical EU-GAP in the core assessment due to a lower spray volume and a lower dose rate (150 L water/ha and 0.075 kg a.s./ha, respectively). However, this does not result in a more worst case exposure scenario and the zRMS states in the core assessment that “This covers applications to vegetables and ornamentals with lower dose rates and higher water volumes”. • For the downward hand-held use : based on the critical EU-GAP using UK-POEM (0.100 kg a.s./ha and 200 L water per hectare) the estimated exposure is 189% of the AOEL without the use of PPE and 93% with the use of PPE (gloves during mixing/loading and application). Also for this scenario, the critical NL-GAP differs from the EU-GAP, but this does not affect the risk assessment (see above ‘downward boom- sprayer use’). Calculations for hand-held spraying in high crops are not supported by the UK-POEM. These are therefore only conducted with the German Model.

Overall, the use of Batavia does not result in an unacceptable risk for operators 1) without the use of PPE for downward boom spraying and upward airblast and hand-held spraying and 2) with the use of PPE (gloves during mixing/loading and application) for hand-held downward spraying.

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) According to the German model (Martin et al, 2008) provided in the core section, there is no undue risk to nearby non-work related bystanders and residents after accidental short-term exposure to Batavia. According to these model calculations, the highest estimated exposures are 3% and 13% of the EU-AOEL for boom spraying and airblast spraying, respectively. In addition to the German model, also the UK model is calculated in the NL addendum using the critical NL-GAP. Using this model, the highest estimated exposures are 1% and 5% of the EU-AOEL for boom spraying and airblast spraying, respectively. Based on these calculations there is no undue risk to nearby non-work related bystanders and residents after accidental short-term exposure to Batavia.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) Worker exposure to Batavia was not evaluated as part of the EU review of spirotetramat. Therefore, all relevant data and risk assessments have been provided in the core assessment. According to the EUROPOEM II model provided in the core by zRMS AT, it is concluded there is no unacceptable risk anticipated for the worker wearing adequate work clothing (excluding PPE), when re- entering crops treated with Batavia. Using this model, the highest estimated exposures is 89% of the EU- AOEL for the task pruning, thinning and harvesting in fruit trees. The other exposure scenarios resulted in lower exposures. NL agrees with the conclusions made by zRMS AT in the core section, but considers that a TC-value of 2500 cm 2/h would be more appropriate for the scouting activities instead of 1100 cm 2/h. However, as the estimated exposure is low (3-6% of the AOEL) for this task, the higher TC-value would not change the final conclusions.

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

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) Spirotetramat was approved under Regulation (EC) 1107/2009 applicable from May 1 st , 2014.

MRLs are set at European level and the review was performed by EFSA. The EU MRLs for the crops that are concerned in this application and which are evaluated in this dossier are summarised in the below table. Most studies submitted for this application were submitted as part of the Annex II dossier, some additional studies were submitted and evaluated and found to be acceptable. However, for some of the crops for which additional trials were submitted, the MRL calculated including the new results was higher than the currently established MRL. These MRLs need to be increased before authorisation can be granted, see table below.

Two Regulations with amended spirotetramat MRLs are currently in force, but not yet applicable: SANTE/12104/2016 and SANTE/11707/2016, concerning changes in the MRLs for pomegranate, other root and tuber vegetables except sugar beets and chicory roots and for kaki fruit, guavas and sweet corn, respectively.

The residue definition for products of plant origin for risk assessment and enforcement is spirotetramat and its 4 metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-monohydroxy, and BYI08330 enol-glucoside, expressed as spirotetramat. During the peer review, a less wide enforcement definition was proposed, but has not yet been adopted in Reg (EC) 396/2005: sum of spirotetramat, spirotetramat-enol, expressed as spirotetramat The residue definition for products of animal origin for risk assessment and monitoring is spirotetramat and its metabolite BYI08330-enol expressed as spirotetramat and for risk assessment Sum of spirotetramat- enol and spirotetramat-enol-GA, expressed as spirotetramat. It is to be expected that the residue definition will be amended following the art 12 review, but this has not started yet, and the expected time of revision of the MRLs and residue definition is therefore unknown.

In RR Part B section 4, MRLs were calculated based on the proposed residue definition of spirotetramat +-enol only, whilst current legislation is based on the wider residue definition of spirotetramat+4 metabolites. Therefore, the proposed MRLs were calculated to reflect the current residue definition.

MRLs, HR and STMR for spirotetramat in the crops evaluated in this dossier MRL adopted but not yet in MRLs calculated in EU MRL (a) force, RR Part B section 4 Crop / animal commodities (mg/kg) SANTE/12104/ (mg/kg) Reg. (EU) 2016 and No 2015/845 SANTE/11707/ Spiro + Spiro + (a) 2016) -enol b 4(a) (mg/kg) Pome fruit 1 0.3 0.4 Cherry 3 1 2.0 Peach, nectarin, apricot 3 0.8 1.5 Plum 3 0.6 1.0 Table and wine grapes 2 0.8 1.0 Strawberries 0.4 0.3 0.3

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MRL adopted but not yet in MRLs calculated in EU MRL (a) force, RR Part B section 4 Crop / animal commodities (mg/kg) SANTE/12104/ (mg/kg) Reg. (EU) 2016 and No 2015/845 SANTE/11707/ Spiro + Spiro + (a) 2016) -enol b 4(a) (mg/kg) Currants 0.2 - 0.5 0.6 Table olives 4 4 Persimmon/Kaki 0.1* 0.3 Kiwi 0.3 Granate apples 0.1* 0.5 Guavas 0.1* 2 Potatoes 0.8 0.3 0.4 Other root and tuber vegetables, except sugar beets 0.1* 0.1 Onions, shallots 0.4 0.3 0.4 Tomatoes 2 Peppers 2 Aubergines 2 Cucurbits (edible and inedible peel) 0.2 Sweet corn 0.1* 1.5 Flowering brassica 1 0.6 1.5 Brussels sprouts 0.3 0.3 0.4 Head cabbage 2 0.3 0.4 Leafy brassica 7 1.0 1.5 Kohlrabi 2 1.5 1.5 Lettuce / lettuce and other salad plants 7 0.7 Spinach & similar (leaves) 7 0.7 Witloof 0.1* 0.05* Herbs 4 5.0 5.0 Legume vegetable (fresh) 1.5 0.9 1.5 Artichoke 1 Olives for oil production 4 Hops 15 5.0 8.0 Chicory roots 0.1* 0.1 All other crops of plant origin 0.1* Residue Amimal Matrices Residue definition definition BYI08330- Mammals BYI08330-enol enol muscle 0.05 fat 0.01* liver 0.07 kidney 0.07 Edible offal 0.07 others 0.01* Poultry, all matrices 0.01* Honey 0.05* Amphibians 0.01* snails 0.01* others 0.01* (*) Indicates lower limit of analytical determination; a according to residue definition for risk assessment : sum of spirotetramat and 4 metabolites; b: according to residue definition for monitoring: sum of spirotetramat and –enol; c: using the OECD MRL calculator.

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An MRL for currants and grapes was applied for, but trials in currants were not supported by appropriate storage stability data. EFSA Journal 2016;14(3):4429, and therefore the MRL increase was not granted. For other small fruits and berries, flowering brassica and Brussels sprouts, the MRL calculated based on the current residue definition – and in some cases the MRL based on the revised residue definition- is higher than the MRLs currently established for these crops. The use on flowering brassica and Brussels sprouts is not intended in the Netherlands. An authorisation cannot be granted for the intended use on currants. In the Netherlands, the use in aromatic herbs and medicinal herbs is requested. The use in aromatic herbs can be supported by trials in lettuce, as it is stated in the Core dossier. An MRL exceedance is not expected. It should be noted that the data in the Core dossier are the same data that were used to set the MRL for herbs (EFSA Journal 2011;9(4):2132). At the time of MRL setting, the ‘old’ EU MRL calculator was applicable and an MRL of 4.0 mg/kg was calculated. When using the ‘new’ OECD MRL calculator on the same data set, the MRL is calculated as 5.0 mg/kg, i.e. an MRL exceedance would be expected. However, it is commonly agreed in the EU that when the same data set is used during MRL setting and a product registration, the EU MRL calculator can still be used. The use in medicinal herbs, however, can only be authorised with the following restriction: ‘Behandelde medicinale kruidgewassen alleen gebruiken voor homeopathische of medicinale doeleinden.’

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. As input parameters the current MRLs, consisting of applicable MRLs, MRLs in force and import tolerances are used, as well as the ADI of 0.05 mg/kg bw/d (EFSA, 2013).

The highest TMDI was 76% for WHO cluster Diet B, all other member state diets were lower. Since the TMDI did not exceed the ADI, a NEDI calculation was not performed. Consumption of spirotetramat residues with food is not expected to impose a chronic risk to the consumer.

In order to evaluate the potential acute exposure to spirotetramat residues through the diet, the International Estimated Short Term Intakes (IESTI) were estimated using the EFSA PRIMo model (revision 2). As input parameters the current MRLs, consisting of applicable MRLs, MRLs in force and import tolerances are used, as well as the ARfD of 1 mg/kg bw (EFSA, 2013).

The maximum IESTI for crops supported in this dossier was scarole with 61.2% of the ARfD for Dutch children ages 1-6. All NESTI for the other commodities for other consumer groups were lower. Since the IESTI did not exceed the ARfD, a National Estimated Short Term Intakes (NESTI) calculation was not performed. 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 Spirotetramat SC 100 G does not lead to unacceptable risk for consumer when applied according to the recommendations.

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 Spirotetramat SC 100 G, 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 for the Central Zone Member Crop Timing of Number of Appl. Max. Max application rate, state* application applications interval single individual treatment min. label rate [g a.s./ha]

BBCH max. [days] [L/ha] Spirotetramat AUT, BEL, 225 Pome & stone fruit 1 1) 6) 69 – 81 2 14 2.25 HUN, POL (max 3 m CH) ROU Pome & stone fruit 2 2) 6) 69 – 81 2 14 1.875 187.5 150 AUT Pome & stone fruit 3 3) 6) 69 – 81 2 14 1.5 (50 g × m CH) AUT, BEL Hop, common 31 – 75 1 - 1.5 150 AUT, BEL, Leafy Vegetables 1 4) 12 – 49 2 14 0.75 75 POL, HUN AUT, BEL, Leafy Vegetables 2 5) 12 – 49 2 14 0.45 45 POL AUT, BEL, Ornamental plants 6) 69 – 89 2 14 0.75 75 POL BEL Tree nursery 6) 69 – 89 2 14 0.75 75

1) i.e., apple, apricot, cherry, peach, pear, plum 2) i.e., apple, pear, plum 3) i.e., apple, apricot cherry, peach, pear, plum 4) i.e., broccoli, Brussels sprouts, chicory/witloof, chinese-, savoy-, red and white cabbage, cauliflower, curly kale, turnip kale, lettuce, spinach 5) i.e., celery leaves, witloof, lettuce and other salad plants. 6) 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. Max application rate, state application applications interval single individual treatment min. label rate [g a.s./ha]

BBCH max. [days] [L/ha] Spirotetramat 225 POL Pome & stone fruit 1 1) 8) 69 – 81 2 14 2.25 (max 3 m CH) 187.5 ROU Pome & stone fruit 2 2) 8) 69 – 81 2 14 1.875 (max 2.5 m CH) BEL, CZE, 150 Pome & stone fruit 3 3) 8) 69 – 81 2 14 1.5 HUN, SVK (max 3 m CH) CZE, ROU, Grape, European 8) 69 – 81 2 14 0.75 75 SVK BEL, CZE, POL, ROU, Leafy Vegetables 1 4) 12 – 49 2 14 0.75 75 SVK POL Leafy Vegetables 2 5) 13 – 49 2 14 0.45 45

BEL, POL Beans, climbing French 71 – 79 2 14 0.75 75 AUT, BEL, CZE, DEU, Currant GBR, HUN, 71 – 85 2 14 0.75 75 (red, white, black) NLD, POL, SVK, SVN BEL, NLD, Onions 6) 13 – 49 4 7 0.75 75 ROU HUN Ornamental plants 8) 69 – 89 2 14 0.75 75

BEL Flower bulbs 8) 69 – 89 2 14 0.75 75 AUT, BEL, CZE, NLD, Potato 8) 69 – 81 9) 4 7 0.75 75 SVK, SVN AUT, BEL, CZE, DEU, 13 – 56 GBR, HUN, Strawberry, garden 7) and 2 14 1.0 100 POL, ROU, 93 – 97 SVK, SVN 49 – 56 NLD Strawberry, garden 7) and 2 14 0.75 75 93 – 97 1) i.e., apricot, cherry, peach, plum 2) i.e., apple, apricot, cherry, peach, pear, plum 3) i.e., apple, apricot, cherry, peach, pear, plum 4) i.e., broccoli, Brussels sprouts, Chinese-, Savoy-, red and white cabbage, cauliflower, chicory/witloof, curly kale, turnip kale, lettuce, spinach 5) i.e., celery leaves 6) also garlic and shallot 7) No application possible less than 14 days before flowering, during flowering and until last harvest. 8) Applications only “after flowering – no flowers present anymore” 9) BBCH 95 in the NLD Addendum

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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.

PECsoil 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, ornamentals, tree nursery, grapes, currants, flower bulbs and leafy vegetables have not been defined in the FOCUS groundwater guidance paper, apples, vines, potatoes, apples, vines, bush berries, onions and cabbage (covering the uses in broccoli, cabbage, cauliflower, curly kale, lettuce and spinach), sugar beets (covering the uses in chicory, kohlrabi and celery - leaves), beans (covering for aromatic and medicinal herbs) and tomatoes (covering the use in Brussels sprouts) 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.

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.

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 1). 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.

Conclusion: None of the simulations for the use of spirotetramat under Dutch cropping conditions (date may result slightly from default, but acceptable) resulted in PECgw values of 0.001 µg/L or lower.

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. For the flowerbulbs the 4 applications are not implemented in the core dossier.

1 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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A National Addendum considering national specific requirements, including 4 applications for flowerbulbs, 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. The worst-case generic surface water body for aquatic exposure assessments represents a shallow ditch at the end of the treated field. 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). The PEC sw and PEC sed simulations for each component considered its specific physico-chemical properties.

According to the use pattern, PEC sw and PEC sed were calculated for the Dutch spring and autumn scenario using standard spray drift rates. According to the Dutch Guidance Document [Ctgb, 20182], exposure via spray drift is quantified by different drift rates for applications in different crop types. Under actual use conditions, the drift exposure may be lower than predicted by the drift rates, due to specific local conditions (e.g. vegetation between field and water body), or due to the use of drift-reducing application techniques (e.g. low-drift nozzles).

The results for PEC sw and PEC sed for the active substance and its metabolites were used for the eco- toxicological 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.

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) Update 31-08-2018 : The applicant added the following minor uses to the GAP: grapes, watercress, rocket, vegetable sprouts and baby leaf crops. The use in watercress is not supported by the current risk assessment due to different possibilities of the cultivation of watercress in the Netherlands. The cultivation of water cress, amongst other methods, is also likely to be semi-wet and therefore, whether

2 Ctgb, 2014: Evaluation Manual for the Authorization of Plant Protection Products and Biocides according to the Regulation 1107/2009, NL part, Chapter 6 Fate and behaviour in the environment: Behaviour in surface water and sediment - version 2.3; April 2018.

Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 31 of 117 this use is covered within the current risk assessment is questionable. Therefore, the minor use in watercress is not supported. The use in grape is covered by the use in berries and currents. Furthermore, the uses in rocket, vegetable sprouts and baby leaf crops are covered by the use in leafy vegetables. Therefore, the minor uses in grapes, rocket, vegetable sprouts and baby leaf crops are acceptable .

Update 25-09-2018: Two other minor uses were added to the GAP: Aromatic herbs and medicinal herbs. These uses are covered by the assessment for leafy vegetables and onions.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Birds and mammals The acute risk assessment for terrestrial vertebrates (birds & mammals) revealed TER values above the trigger. The long-term risk assessment for mammals resulted also in TER values above the trigger. For the chronic risk to birds, higher tier risk assessments were necessary for some uses. 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. 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.

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

The risk from drinking water and secondary poisoning was addressed and was found to be acceptable.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)

The risk assessment based on maximum PEC sw values derived by Dutch specific calculations revealed TER values above the required triggers for fish, invertebrates and all other aquatic organisms including sediment dwellers ( C. riparius ), which turned out to be the most sensitive species. According to the presented risk assessment, a risk to aquatic organisms from exposure after use of the product as described in this dossier is unlikely.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees The hazard quotients for oral and contact exposure are below the trigger value of 50. However, in bee brood feeding tests effects on bee brood were detected and further consideration was required. It was concluded in the core assessment that based on the found effects on bee brood in semi-field studies the risk for bees is only acceptable when Spirotetramat SC 100 is not applied in flowering crops. The off- field risk assessment for bees has been presented in the NL addendum. The maximum worst-case off-field rate for the use in tree nursery is calculated to be 30.6 g/ha. All HQ values are below the trigger of 50 and also below the rate of 74.4 g a.s./ha in the semi-field study at which no effects were seen. Therefore, it can be concluded that no unacceptable risk for bees in the off-field area has to be expected from the use of the product according to the proposed use pattern.

The following was mentioned in the core assessment: “Independent from the crop-specific assessments below, there is a potential risk via exposure from non-crop vegetation (in the crop or adjacent to the crop). Because this depends on national cropping practise, labelling in this respect (Spe 8) should be considered at MS level. ”

Therefore, to prevent flowering of weeds in the field, Spe 8 needs to be prescribed. 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

Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 32 of 117 worden door bijen en hommels. Gebruik dit product niet op plaatsen waar bijen actief naar voedsel zoeken. Gebruik dit product niet wanneer bloeiende onkruiden aanwezig zijn. Gebruik dit product niet in de buurt van in bloei staand onkruid. Verwijder onkruid voordat het bloeit. Na een gewasbehandeling percelen nog minimaal twee weken vrijhouden van bloeiende onkruiden.

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

Other non-target arthropods

In-field risk assessment

The tier 2 in-field risk assessment (based on the most and less critical intended uses) for A. rhopalosiphi, C. carnea and C. septempunctata indicates that no unacceptable adverse effects are to be expected in the in-field area for arthropod species with a similar sensitivity as these species, except for the most critical use in orchard, late. The risk assessment for T. pyri indicates that initial effects in the in-field area cannot be excluded. Therefore, further refinement is needed for all species in orchard, late and for T. pyri for all uses.

Considering the results of the aged residue study and the field trials conducted with the OD 150 formulation, the fact that the SC 100 formulation has been proven to be less toxic to Typhlodromus pyri than the OD formulation, and the short dissipation time of spirotetramat on leaves, it can be concluded that the application of Spirotetramat SC 100 according to the intended use pattern will not pose an unacceptable in-field risk to non-target arthropods

An acceptable in-field risk was concluded in the core assessment.

The off-field risk was assessed in the NL addendum.

The risk assessment according to country specific requirements did indicate unacceptable adverse effects on non-target arthropods off-field habitats for uses in fruit crops and tree nursery. The risk to non-target arthropods from use in fruits crops and tree nursery cannot be excluded and risk mitigation measures need to be prescribed.

• Mitigation in fruit crops: Under the class DRT90 with a crop free zone of 3m following the new

Activity Decree, a drift of 3.8% is expected leading to a PER off-field of 58.14 [g a.s./ha].This is also covered in the class DRT75 with a crop free zone of 4.5m which is now standard practice in the Netherlands and therefore, a separate restriction sentence does not need to be mentioned on the label.

• Mitigation in tree nursery: Under the class DRT50 a maximum 26% drift is obtained resulting in

a PER off-field of 198.9 [g a.s./ha] for high lane trees, which also covers transplanted trees and spindle trees. For class DRT0 a crop free zone of 500 cm (corresponding to a max drift of 1.6%) also leads to an acceptable risk.

The following restriction sentence should be placed on the label:

Om niet tot de doelsoorten behorende insecten/geleedpotigen/terrestrische planten te beschermen is toepassing van dit middel in hoge laanbomen (>5 meter) uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT50, dan wel een teeltvrije zone van 500 cm (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelsrand) in acht wordt genomen.

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This restriction sentence is also applicable to non-target terrestrial plants.

IPM: To protect natural enemies, the following warning sentence should 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.

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.

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 all uses.

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, 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 (DT 90 = 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 are not required. Even though the DT 90, 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 PEC soil values for Folsomia (spirotetramat) and Hypoaspis (BYI08330-enol), indicating no unacceptable risk for soil non-target macro-organisms for all uses. However, the TER value for Hypoaspis (spirotetramat) - based on the endpoint from a formulation study with Spirotetramat SC 100 G - is below the trigger for some uses on pome&stone fruit, onions and strawberry, early indicating a need for further calculations.

The applicant provided a weight of evidence assessment.

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The critical TER values of the risk assessment as performed in the risk assessment are even closer to the trigger of 5 than in the core risk assessment and the Ctgb can agree with the applicant’s weight of evidence assessment as presented above. Hence, the risk other non-target soil macro-organisms can be considered acceptable. It is noted that Austria mentions a correction factor of 5 regarding the peat content in their weight-of- evidence approach. Ctgb assumes that the standard correction factor of 2 is meant.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) The risk is acceptable.

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 Spirotetramat SC 100 G 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) Non-Target Plants According to the results of the deterministic approach involving the most sensitive endpoint in the vegetative vigour study (dry weight of corn), the trigger of 5 is already met in currants, onions & potatoes and leafy vegetables at the default distance with conventional spraying equipment. However, mitigation is required for uses in fruit crops and tree nursery.

• Mitigation in fruit crops: Under the class DRT90 with a crop free zone of 3m following the new

Activity Decree, a drift of 3.8% is expected leading to a PER off-field of 11.62 [g a.s./ha].This is also covered in the class DRT75 with a crop free zone of 4.5m which is now standard practice in the Netherlands and therefore, a separate restriction sentence does not need to be mentioned on the label.

• Mitigation in tree nursery: Under the class DRT50 a maximum 26% drift is obtained resulting in

a PER off-field of 39.78 [g a.s./ha] for high lane trees, which also covers transplanted trees and spindle trees. The resulting TER is 4.9. This is just below the factor of 5, but considered acceptable, considering the fact that this value was the lowest of 10 tested species.

The following restriction sentence should be placed on the label:

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This is a combined restriction sentence for NTAs and NTTPs.

Other non-target species (Flora and Fauna)

Tests on other non-target species are not required.

3.1.7 Efficacy (Part B, Section 7, Point 8) The proposed product Batavia (SPT SC100) is a suspension concentrate containing 100 g/L of spirotetramat. It is an insecticide for the control of aphids, scales and mealybugs, psyllids, whiteflies, mites and midges. For some European countries in the Maritime zone it concerns a re-registration. In NL the formulation of the proposed product is not authorised yet. An oil dispersion product based on 150 g/L spirotetramat (SPT OD150) is authorised since 2011 in a broad range of crops. ZRMS evaluation is based on authorised uses in several European countries, trial results of the proposed product and trial results of the bridging product (OD formulation).

The uses in cherry, plum, currant, black and raspberry family, shallot, aromatic and medical herbs are applied as a minor use (article 51). For these uses efficacy and phytotoxicity are not evaluated and therefore a disclaimer is given on the label.

The spectrum of efficacy and preliminary range-finding tests have been presented in the context of the initial submission, and no new data on aphids, whiteflies, scales, are presented. A new laboratory study is presented, to characterize the potential of spirotetramat against thrips, taking Frankliniella occidentalis as model. Spirotetramat is effective against larvae of thrips, and exhibits lower control of adults, but reduction in the females’ fecundity.

Bridging of different SPT formulations Minimum effective dose trials or efficacy trials include different formulations of spirotetramat: Spirotetramat OD100 or OD150 (SPT OD100; SPT OD150), Spirotetramat SC240 + tank-mix adjuvant (SPT SC240 + RME, + Stefes Mero), and a few others. In most trials SPT SC100 and SPT OD150 resp. SPT SC240 achieved comparable levels of efficacy. In some trials SPT OD150 clearly outperformed SPT SC100 (and other SC formulations), in particular when the SC formulation was applied without additive (for SPT SC100 currently only claimed for brassica crops), or against “woolly” pests difficult to control such as Eriosoma . Then also SPT SC240 + additive showed also a higher initial effect compared to SPT SC 100. Overall, trials conducted with SPT OD150 resp. SPT SC240 are regarded to be acceptable to support the assessment of SPT SC100, if the possibly weaker performance of SPT 100 SC is kept in mind. Not for all claimed crop-pest combinations is the bridging approach used. In general the bridging product is used as an additional explanation to prove the efficacy.

Minimum Effective Dose Potato; Aphis spp. (0.75 L/ha / 75 g a.s./ha) To justify the dose of 75 g a.s./ha to control APHISP in SOLTU, the applicant presented 8 trials from the EPPO Maritime zone, and 3 trials from the EPPO North-east zone, which all were assessed together. In addition to the proposed dose of 75 g a.s./ha (1 N), one lower dose of 45 g a.s/ha (0.6 N) was assessed. Even though in most trials at most assessment times no statistically significant difference was seen between the two dose rates, the higher dose of 75 g a.s./ha resulted in higher levels of efficacy in terms of

Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 36 of 117 numbers, and indicated also a better lasting effect in the Maritime zone. Overall, the proposed minimum effective dose of 75 g a.s./ha can be agreed .

Apple and pear; Aphis spp. (0.15 % (max 1.8 L/ha) = 0.75 L/ha/m ch (max 2.4 m ch)) The first minimum effective dose tests (EPPO Maritime zone) to control aphids in apple assessed by the ZRMS were conducted at doses of 24 g a.s./ha/m ch , 37.5 g a.s/ha/m ch, 45 g a.s./ha/m ch, 48 g a.s./ha/m ch, 60 g a.s./ha/m ch, 75 g a.s./ha/m ch, 90 g a.s./ha/m ch, 96 g a.s./ha/m ch, 112.5 g a.s/ha/m ch. The most appropriate dose for the control of aphids on pome fruit seemed to be in the range of 48 to 96 g a.s./ha/m ch. Six new trials against Aphis pomi , not submitted before, were presented in addition to 2 trials from BE and DE already submitted in MS level. In the 4 trials targeting Aphis pomi (DE, BE) no clear dose response was seen between 52.5 and 75 g a.s/ha/m ch, except for a slightly better initial effect and overall efficacy of the higher dose. In Swiss trials, Aphis spiraecola was assessed at doses of 62/65 and 86/89 g a.s./ha/m ch, known to be a species difficult to control. Clear dose response was seen. The ZRMS concluded that overall, a dose of 2.25 l/ha (0.75 l/ha/m ch) is supported, covering all aphididae such as APHISP, DYSAPL/DYSAPY and ERISLA. An effective dose of 0.15% is justified.

Apple; Eriosoma lanigerum (0.15 % (max 1.8 L/ha) = 0.75 L/ha/m ch (max 2.4 m ch)) The minimum effective dose tests to control Eriosoma lanigerum (ERISLA) in apple in EPPO Maritime zone were conducted in 10 trials at doses of 24, 48, 60 and 72/75 g a.s./ha/m ch. The highest dose clearly provided the best control and highest persistency. These data confirmed a dose of 1.8 l/ha to be the minimum effective dose.

Pear; Aphis spp. and Psylla piri (0.15 % (max 1.8 L/ha) = 0.75 L/ha/m ch (max 2.4 m ch)) Five trials from the EPPO Maritime zone (all already submitted on MS level) are presented. The applicant’s conclusion can be agreed that for a high and reliable result to control PSYLPI in pears the target dose rate of 75 g a.s./ha/m ch is necessary. A reduction of rate is not recommended. Additionally a single non-GEP trial is presented (Switzerland, 2007) not yet submitted before, confirming 72/75 g a.s/ha/m ch to be the minimum effective dose. The minimum effective dose tests to control Psylla spp. in pear previously assessed by the ZRMS were conducted at doses of 24, 48, 60 and 72/75 g a.s./ha/m ch, demonstrating the highest dose to clearly provide the best control and highest persistency. These data confirmed a dose of 1.8 l/ha to be the minimum effective dose.

Strawberry; Aphis spp. (0.75 L/ha / 75 g a.s./ha) In the single Maritime zone trial ( Macrosiphon euphorbiae , 1 pre-flower application) no significant difference was seen between the assessed doses of 0.75 and 1 l/ha at the final assessment. However, at earlier assessments in terms of numbers a clear benefit of the higher dose was seen. Furthermore, 5 trials carried out under protected condition were presented. According to EPPO Extrapolation tables for Minor Uses, efficacy extrapolation from trials carried out under protected conditions to field conditions is acceptable. According to the Dutch extrapolation table extrapolation of efficacy is possible from the control of aphids in protected strawberry to unprotected strawberry. Several aphid species such as Aphis gossypii (2 Spanish trials), Macrosiphon euphorbiae , and Rodobium porosum (1 Dutch trial), Chaetosiphon fragaefolii (1 French trial), Aphis forbesi (1 French trial) were assessed. No significant difference was seen between the assessed doses of 0.75 and 1 l/ha at the final assessment. In 2 trials a benefit of >10% of the higher dose was seen in terms of numbers at early assessments. Even though in some trials a benefit of the higher dose was seen in terms of numbers, no significant difference was seen between the two tested doses (0.75 and 1 L/ha), and the proposed minimum effective dose of 0.75 L/ha can be agreed.

Grape; Myzus persicae 0.075% (max 0.75 L/ha) No minimum effective dose trials were presented for other aphid species than Viteus vitifoliiae (VITEVI) in the South-east zone, therefore the minimum effective dose is not justified.

Lettuce; Aphis spp. (0.75 L/ha / 75 g a.s./ha)

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For the control of Nasonovia ribisnigri the zRMS concluded that 45 g a.i./ha can be accepted as Minimum effective dose. No minimum effective dose trials are available for other foliar aphids on lettuce. The applicant did not address the need for the higher dose of 0.75 l/ha (proposed dose in NL) for the control of aphids in the EPPO Maritime zone. Based on the lower acceptable dose according the ZRMS and the knowledge gained from the Movento 150 OD-formulation (bridging product SPT OD150) authorised in NL at a dose of 75 g a.s./ha against aphids ( Nasonovia ribis-nigri, Myzus persicae, Aphis gossypii and Uroleucon sonchi ) in lettuce, the proposed minimum effective dose of 0.75 L/ha can be agreed. It is expected that (including a somewhat weaker performance of the SC formulation) the claimed dose is the minimum effective dose against the same aphids. According to the Dutch extrapolation list, extrapolation for efficacy is possible from leaf aphids in iceberg lettuce to the same aphids in Lactuca sativa spp., lamb’s lettuce and endive. According to EPPO extrapolation for efficacy for the pest group aphids is possible from lettuce (LACSS) to leafy vegetables of the Asteraceae, Chenopodioideae and Valerianella sp. As the justification is based on efficacy trials in lettuce and the bridging product which is authorised in lettuce ( Lactuca spp.) endive and spinach family, extrapolation to endive (Asteraceae), lamb’s lettuce (Valerianella) and spinach (Chenopodioideae) is possible. The whole spinach family belongs not to the Asteraceae, Chenopodioideae and Valerianella sp..

Lettuce; Pemphigus bursarius (0.75 L/ha / 75 g a.s./ha) Four trials, all from the EPPO Maritime zone included reduced dose rate of the different formulations tested compared to the proposed dose rate of 75 g a.s./ha. Though not all trials provided clear justification, 75 g a.s./ha can be accepted for a constant and secure efficacy as minimum effective dose. Extrapolation to other leafy vegetables than lettuce is not possible.

Onion; Thrips tabaci (0.75 L/ha / 75 g a.s./ha) To demonstrate dose response of SPT SC100 against THRITB in ALLCE, the applicant presented 4 trials from France (EPPO Maritime zone). In the trials in addition to the target dose of 75 g a.s./ha only one lower dose of 45 g a.s./ha was assessed. Even though in three of four of these trials no statistically significant difference was seen between the two dose rates in question, the higher dose of 75 g a.s./ha resulted in higher levels of efficacy in terms of numbers. Currently SPT 150 OD is authorized at 75 g a.s./ha to control thrips in onion in the Netherlands (and at 72 g a.s./ha in Germany). The proposed minimum effective dose of 75 g a.s./ha can be agreed.

Flower bulb and flower tuber crops; Aphis spp. 0.75 L/ha Floricultural crops; Aphis spp. 0.075% (max 0.75 L/ha) Perennial crops; Aphis spp. 0.075% (max 0.75 L/ha) Tree nursery crops; Aphis spp. 0.075% (max 0.9 L/ha) Three Dutch greenhouse trials (2012, Chrysanthemum) were carried out. Two different spray concentrations, 0.045 and 0.075%, of SPT SC100 were assessed against APHIGO on CHYIN. A benefit of the higher dose in terms of numbers was seen at several assessments times, and a statistically significant difference was recorded at 2 assessment times in one of three trials. In addition, based on the knowledge gained from the Movento 150 OD-formulation (bridging product SPT OD150) authorised in NL at comparable active ingredient amount: 0.5 L/ha against aphids in flower bulb and flower tuber crops, 0.05% (max 0.6 L/ha) against aphids in tree nursery crops and at 0.05% (max 0.5 L/ha) in perennial crops, the proposed minimum effective dose of 0.75 L/ha or 0.075% can be agreed against the same aphids. Extrapolation is possible from the tested and authorised ornamental uses to floricultural crops. Overall it can be concluded that the proposed dose rates in ornamental crops are justified.

Efficacy Potato; Aphis spp. (0.75 L/ha / 75 g a.s./ha) Results from 11 trials were used to demonstrate efficacy of SPT 150 OD against different aphid species (AULASO, MYZUPE, APHINA, MACSEU, APHIFG). Results of 3 different leaf levels (5 trials) were presented to demonstrate efficacy of SPT OD150 or SPT SC100 to be not greatly affected by the foliar level. A sufficient level of efficacy (82%, 12-15 DAA) was observed on the levels which were highest

Part A Batavia Registration Report – Central Zone National Assessment - The Netherlands Page 38 of 117 infested (low and middle), and equal or numerically better performance was seen in compared to the reference product. Across 9 trials (averaging all leaf levels and aphid species), SPT OD150 clearly outperformed SPT SC100. The reference product TCP achieved equal efficacy, whereas DLT+TCP performed significantly weaker. Overall, in most trials the test product achieved at least a moderate level of efficacy (mean of 8 trials, excluding the Swiss trial: 73.4%). ZRMS concluded that data are regarded to be supportive for Aphis spp. control in potato as a major use.

Apple and pear; Aphis spp. (0.15 % (max 1.8 L/ha) = 0.75 L/ha/m ch (max 2.4 m ch)) In the 7 trials conducted in the EPPO Maritime zone best results against rosy apple aphid (Dysaphis plantaginea ) were gained using a higher dose of 75 g a.s./ha/m ch, with the next lower dose of 56 g a.s./ha/m ch showing a weaker initial effect. 16-19 DAA sufficient levels of control of DYSAPL were achieved (average 85%, DK, SW trials), resp. 14DAA 90.5-98.3 % (DE and BE trials). The efficacy of Spirotetramat SC100 at 75 g a.s/ha/m ch was tested in 9 trials against Aphis spp.; 7 trials against Aphis pomi and 2 trials against Aphis spiraecola in apple. In all trials a very high level of control was achieved from 2 DAA up to 4 weeks after a single application. According to the Dutch extrapolation table and base on expert judgement extrapolation of efficacy is possible from the control of Dysaphis plantaginea and Aphis pomi in apple to all claimed aphids in apple and pear. The use against Aphis spp. in apple and pear is justified.

Apple; Eriosoma lanigerum (0.15 % (max 1.8 L/ha) = 0.75 L/ha/m ch (max 2.4 m ch)) The woolly apple aphid (ERISLA) typically requires higher doses to be sufficiently controlled, compared to other aphid species. In the presented trials (2 EPPO North-east, 1 + 9 Maritime zone, 5 South-east zone), the dose of 75g a.s./ha/m ch showed high levels of control (min. 86 %) a week after one or two applications. SPT SC100 performed comparably or better than the reference product. The use against ERISLA in apple is justified.

Strawberry; Aphis spp. (0.75 L/ha / 75 g a.s./ha) To demonstrate efficacy pf SPT SC100 at 0.75 L/ha to control different aphid species on strawberry, the applicant presented 14 trials conducted in the EPPO Maritime zone (4 trials), EPPO Mediterranean zone (1 trials), and in the greenhouse (9 trials). Assessed species were APHIGO, CHTSFR, APHIFO, MACSEU, APHIFG, MYZUPE, MACSRO, METOPO and ACYRKO. Since the performance of SPT SC100 in the single Mediterranean zone trial was comparable to Maritime zone trials, all trials were assessed together. SPT SC100 or OD150 showed good control (average across trials 87.4 % efficacy, 3-12 DAA/DAB, resp. 89.1 % efficacy, 19-50 DAA/DABB) against several aphid species both in the field and the glasshouse, demonstrating high knockdown effect as well as persistency. Compared to the reference products, SPT showed similar or higher control of aphids. According to EPPO Extrapolation tables for Minor Uses, efficacy extrapolation from trials carried out under protected conditions to field conditions is acceptable. According to the Dutch extrapolation table extrapolation of efficacy is possible from the control of aphids in protected strawberry to unprotected strawberry. The use against Aphis spp. in strawberry is justified.

Grape; Myzus persicae 0.075% (max 0.75 L/ha) No efficacy trials were presented for other aphid species than Viteus vitifoliiae (VITEVI) in the South- east zone, therefore efficacy is not justified for the use against Myzus Persicaea in grapes.

Lettuce; Aphis spp. (0.75 L/ha / 75 g a.s./ha) The zRMS concluded that the higher dose of 75 g a.s./ha, instead of 45 g a.s./ha, against Nasonovia ribisnigri cannot be supported. The applicant did not address the need for the higher dose of 0.75 l/ha (proposed dose in NL) for the control of aphids in the EPPO Maritime zone. Based on the knowledge gained from the Movento 150 OD-formulation (bridging product SPT OD150) authorised in NL at a dose of 75 g a.s./ha (0.5 L/ha) against aphids ( Nasonovia ribis-nigri, Myzus persicae, Aphis gossypii and Uroleucon sonchi ) in lettuce, the use in lettuce against these aphids is justified.

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According to the Dutch extrapolation list, extrapolation for efficacy is possible from leaf aphids in iceberg lettuce to the same aphids in Lactuca sativa spp., lamb’s lettuce and endive. According to EPPO extrapolation for efficacy for the pest group aphids is possible from lettuce (LACSS) to leafy vegetables of the Asteraceae, Chenopodioideae and Valerianella sp. As the justification is based on efficacy trials in lettuce and the bridging product which is authorised in lettuce ( Lactuca spp.) endive and spinach family, extrapolation to endive (Asteraceae), lamb’s lettuce (Valerianella) and spinach (Chenopodioideae) is possible. The whole spinach family belongs not to the Asteraceae, Chenopodioideae and Valerianella sp..

Lettuce; Pemphigus bursarius (0.75 L/ha / 75 g a.s./ha) To demonstrate efficacy of SPT SC100 against PEMBU on lettuce, the applicant presented 8 trials carried out in the Maritime zone. SPT SC100 at 75 g a.s./ha was highly effective against P. bursarius in lettuce and Belgian Endive. References products, containing neonicotinoids, performed weaker. The use against Pemphigus bursarius in lettuce is justified. Extrapolation to other leafy vegetables than lettuce is not possible.

Onion; Thrips tabaci (0.75 L/ha / 75 g a.s./ha) In EPPO Maritime zone trials (5 French and 4 German trials) the test product was demonstrated to perform comparable to reference products. The efficacy against living insects was moderate 84.6 % (1-2 weeks after 1-4 applications) resp. only 77.7 % (at the highest infestation) for SPT SC100 in French trials, and 96.2 % resp. 93.9 % for SPT OD150 in German trials. Overall, the target dose of 75 g a.s./ha achieved moderate to high levels of control (78-96 % efficacy) regarding reduction of living THRITB. Feeding damage was reduced to a lower extent by SPT OD150, however, still outperforming the reference products in 3 of 6 trials (in 1 trial the reference outperformed the test product) on a statistically significant different level. The zRMS concluded that data are regarded to be supportive for a major use.

Flower bulb and flower tuber crops; Aphis spp. (0.75 L/ha / 75 g a.s/ha) Floricultural crops; Aphis spp. 0.075% (max 0.75 L/ha) Perennial crops; Aphis spp. 0.075% (max 0.75 L/ha) Tree nursery crops; Aphis spp. 0.075% (max 0.9 L/ha) The zRMS conclusions: To address the efficacy of SPT 100 SC at 75 g a.s./ha to control APHIGO on ornamentals (including flower bulbs), the applicant presented field (5) and green house trials (3+5) from the EPPO Maritime zone only. ZRM concluded that the presented field data seem sufficient for a minor use in the EPPO Maritime zone, however, to be limited to the assessed species (flower bulbs, Lilium). CMS may decide if extrapolation to other field-grown ornamentals is possible, resp. to other aphid species. However, ornamentals are high growing crops, therefore the applied dose needs to be linked to crop height. The applicant provided a ‘Statement on efficacy floriculture crops’. In this statement 2 conclusions were made: - The active substance is already registered for the uses applied for in the Netherlands in a different formulation (150 OD instead of 100SC) in the same rate/ha for the active substance. The higher rate of 90 gr ai/ha in nursery stock addresses the remark of the zRMS that “ornamentals are high growing crops, therefore the applied dose needs to be linked to crop height”. As the Dutch GAP is in % rate, the rate is “automatically” adjusted to the crop height. - The zRMS states that “the applicant presented field (5) and green house trials (3+5) from the EPPO Maritime zone”. According to the argumentation above the glasshouse trials with cotton aphid under glass can be used to substantiate the efficacy outdoors for all claimed aphid species.

Based on the knowledge gained from the Movento 150 OD-formulation (bridging product SPT OD150) authorised in NL at a dose of 75 g a.s./ha against aphids in flower bulb and flower tuber crops, 0.05% (max 0.6 L/ha) against aphids in tree nursery crops and at 0.05% (max 0.5 L/ha) in perennial crops, efficacy of the proposed dose of 0.75 L/ha or 0.075% can be agreed against the same aphids. Extrapolation is possible from the tested and authorized ornamental uses to floricultural crops.

According to the Dutch extrapolation list:

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Extrapolation is not possible to unprotected productions, because: - the climate conditions are totally different between protected cultures and unprotected cultures - the cultures are not always comparable - the infestation in the field is often higher (with the exception of cotton aphid) Extrapolation is possible from cotton aphid (APHIGO) in protected cultures to unprotected cultures, because cotton aphid is hardly seen outdoors.

The use against the claimed aphids in claimed ornamental crops is justified.

Quality Quality assessments were carried out in strawberry and onion only. The impact of SPT SC100 on the quality of strawberries has been evaluated in 4 GEP trials carried out in field in Belgium in 2009 (1 trial), in Poland (2011), and under greenhouse in the Netherlands in 2007 (2 trials). No negative effects in fruit quality (number, weight and content parameters) were found. The impact of the application with SPT SC100 on the quality of onions has been studied in one GEP plant safety trials in absence of pests carried out in field onion in Northern France in 2013. No negative effects in size of bulbs was found. ZRMS concluded that even though no taint assessments with fresh fruit were carried out, any negative effect on the quality of strawberry yield is unlikely. Currently only post-harvest and pre-flowering applications are intended, thus assessments of the quality of fresh fruit can be waived. Taking into account the good crop safety of SPT SC100, no effect on the quality of plants and plant products is expected following applications, when applied according to the recommendations. In addition the bridging product SPT OD150 is authorized since 2011 in The Netherlands on comparable crops. No negative effects on quality are known for this product.

Processing procedure Processing procedure in pome fruit, stone fruit, Brussel sprouts, lettuce, hop Most of the presented studies in apple, peach, hops, Brussel sprouts, and lettuce were carried out with Spirotetramat OD150. It is claimed that the results with this formulation are valid for SPT SC100, as both formulations contain penetration enhancer in a comparable ratio active substance/penetration enhancer. ZRMS considers only studies carried out with SPT SC100 to be fully supportive, since the formulation type may have an impact on taste and smell of the processed yield if applied close to harvest. However, penetration properties of SPT SC100 are weaker compared to OD formulations, in particular on crops with relevant wax layer on leaves or fruits. Therefore, it is more likely (if at all) that OD formulations, or SC formulations + additive may cause taint, or affect fermentation, compared to SC formulations applied without additive. Overall, there are no reports of significant taint in the tests. In taint tests concerning the OD150 formulation, single incidences of taint occurred during trials for earlier registration, for example in apple compote or peach nectar. These were however not statistically significant and therefore negligible.

Processing procedure in onion, potato, spinach, strawberry, currant Specific studies were also conducted to support the extensions of uses in onion, potato, strawberry, and currant. In none of the studies any taint effect was described following the various processing and sensory analysis. Based on the results of the studies presented and evaluated above, the applicant concluded that the commercial application of SPT should not produce any detrimental effects on the quality and the transformation processes which apply to all considered crops. This conclusion can be agreed.

Processing procedure in grapevine No fermentation studies were carried out. Applications are intended from BBCH69 - End of flowering up to BBCH81 - Beginning of ripening, therefore an impact on fermentation processed cannot be excluded. However, corresponding studies can be waived, since the use is limited to nurseries, as applied for authorization in some countries. In other countries where no limitation to nurseries is intended, according to EPPO, minimum 6 fermentation studies should be provided. For such uses data demands are clearly not met.

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Yield To address the possible impact of SPZ SC100 on the yield of strawberry, chicory (Belgian endive), onion and shallot, the applicant presented 4 Maritime zone trials. No negative effect on the amount of yield was recorded. Overall, no adverse effects are to be expected on the yield from proper application of Spirotetramat SC100 at the indicated dose.

Adverse effects Phytotoxicity Crop safety field trials carried out between 2007 and 2011 in apple, strawberry, cabbages, lettuce, hop, flower bulbs and ornamentals were presented. In the efficacy trials phytoxicity was assessed. No agronomical relevant phytotoxicity symptoms caused by SPT SC100 sprayed in potato, apple, cherry, plum, peach, strawberry, black currant, spinach, cabbage and onion were recorded in the efficacy and crop safety trials, when sprayed up to the maximum proposed use rate of 2.25 L/ha. As the efficacy in ornamental crops is generally based on the bridging product, the same warning sentence for ornamental crops will be given on the Dutch label:

Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden van bloembol- en bloemknolgewassen, bloemisterijgewassen, vaste plantenteelt en boomkwekerijgewassen 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).

Propagating purposes Three GEP trials were carried out in 2012 in NL in order to check the germination of daughter tubers, following the use of spirotetramat. All trials were conducted with SPT OD150. From the trial results it can be concluded that SPT OD150 when applied as recommended will not have any deleterious effect on the germination and growth of the daughter tubers in potato. Penetration properties of SPT SC100 are weaker compared to OD formulations. Therefore, it is more likely that OD formulations, or SC formulations + additive may cause adverse effects, compared to SC formulations applied without additive.

Succeeding and adjacent crops The applicant claimed that after several years of field testing, no negative influence on succeeding crops has been reported following applications of Spirotetramat formulations in ornamentals or vegetables. To demonstrate the safety of SPT SC 100 to succeeding crops in a worst-case scenario, the product was tested in a pre-emergence test on ten species of terrestrial non-target plants. Test plants were treated at an application rate of 216 g a.i./ha with Spirotetramat SC 100 g/L. The species tested were corn ( Zea mays ), oat ( Avena sativa ), ryegrass ( Lolium perenne ), cucumber ( Cucumis sativus ), oilseed rape ( Brassica napus ), soybean ( Glycine max ), sugar beet ( Beta vulgaris ), sunflower ( Helianthus annuus L.), tomato (Lycopersicon esculentum ) and buckwheat ( Fagopyrum esculentum ). At a nominal application rate of 216 g a.s./ha, Spirotetramat SC 100 showed no adverse effect in any of the tested species.

Possible development of resistance or cross-resistance Spirotetramat is a member of the ketoenol class of insecticides and a well-established tool for the control of homopteran pests such as aphids, psyllids and whiteflies. Spirotetramat insecticide is classified by IRAC in mode of action class 23, inhibitors of acetyl-CoA-carboxylase. The applicant claimed that no resistance case in any pest is yet described with Movento containing the active ingredient spirotetramat. However, at least in aphids resistance against spirotetramat already was detected.

The zRMS concluded that regarding both the new uses and the uses applied for renewal, and considering both the inherent resistance risk of spirotetramat and of the pests such as aphids, white flies and thrips, resistance development is not only possible, but even likely. Therefore the unrestricted use of spirotetramat is considered bearing an unacceptable resistance risk.

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Without current sensitivity data of aphids, white flies, and thrips, zRMS recommends to reconsider a further limitation of these uses on national level. E.g.: further reduction of the number of applications per crop and year, corresponding label warnings e.g. to avoid applications to subsequent pest generations, and to limit the number of SPT applications per crop and year across products.

On the Dutch label the following warning sentence is given:

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.

The uses in grapes, rocket, vegetable sprouts and baby leaf crops are after rejection by efficacy applied as a minor use (article 51). For these uses efficacy and phytotoxicity are not evaluated and therefore a disclaimer is given on the label.

3.2 Conclusions The assessment conducted for Batavia was in accordance with the Uniform Principles and demonstrates an acceptable risk to human health and the environment. An authorisation can therefore be granted except for the use in currant (red, white and black). Furthermore, the claim against Pemphigus bursarius LINNAEUS can only be authorised in lettuce.

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.

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Appendix 1 – Copy of the product label Wettelijk gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als insectenbestrijdingsmiddel in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden.

Toepassingsgebied Type toepassing Te bestrijden Dosering Maximale Maximaal Minimum Veiligheidstermijn organisme (middel) dosering aantal interval in dagen per (middel) toepassingen tussen toepassing per per toepassingen toepassing teeltcyclus of in dagen per 12 maanden Aardappel Gewasbehandeling bladluis 1, 2, 3, 24, 26 0,75 L/ha 0,75 L/ha 4 per 7 14 na de bloei teeltcyclus Appel Gewasbehandeling bladluis 6,7,8,9 0,15% 1,8 L/ha 2 per 12 14 21 (onbedekte teelt) na de bloei appelbloedluis 10 (150 ml maanden middel per 100 liter water) Peer Gewasbehandeling bladluis 6,9,11,12,13 0,15% 1,8 L/ha 2 per 12 14 21 (onbedekte teelt) na de bloei bladvlo 14 (150 ml maanden middel per 100 liter water) Aardbei Gewasbehandeling bladluis 1,20- 0,75 L/ha 0,75 L/ha 2 per 12 14 - (onbedekte teelt) (toepassing 14 22,24,26,28-31 maanden dagen voor bloei, danwel na-oogst) Sla; Lactuca spp. Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (onbedekte teelt) wortelluis 19 maanden Sla; Lactuca spp. Gewasbehandeling wortelluis 19 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (bedekte teelt) maanden Andijvie Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (onbedekte teelt) maanden

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Toepassingsgebied Type toepassing Te bestrijden Dosering Maximale Maximaal Minimum Veiligheidstermijn organisme (middel) dosering aantal interval in dagen per (middel) toepassingen tussen toepassing per per toepassingen toepassing teeltcyclus of in dagen per 12 maanden Spinazie Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (onbedekte teelt) maanden Spinazie-achtigen Gewasbehandeling bladluis 20, 21, 22, 23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (bedekte teelt) maanden Veldsla Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (onbedekte teelt) maanden Uien Gewasbehandeling trips 34 0,75 0,75 L/ha 4 per 7 7 (onbedekte teelt) teeltcyclus Bloembol- en Gewasbehandeling bladluis 0,75 L/ha 0,75 L/ha 4 per 14 - bloemknolgewassen na de bloei 1,4,21,22,24,26 teeltcyclus (onbedekte teelt) Bloembol- en Gewasbehandeling bladluis 1, 21, 22, 24, 0,75 L/ha 0,75 L/ha 6 per 12 14 - bloemknolgewassen 26, 37 maanden (bedekte, niet-grond gebonden teelt) Bloembol- en Gewasbehandeling bladluis 1, 21, 22, 24, 0,75 L/ha 0,75 L/ha 2 per 12 14 - bloemknolgewassen 26, 37 maanden (bedekte, grondgebonden teelt) Bloemisterijgewassen Gewasbehandeling bladluis 0,075% 0,75 L/ha 2 per 14 - (onbedekte teelt) na de bloei 1,4,21,22,24,26 (75 ml teeltcyclus middel per 100 liter water) Bloemisterijgewassen Gewasbehandeling bladluis 22 0,075% 0,9 L/ha 6 per 12 14 - (bedekte, niet-grond (75 ml maanden gebonden teelt) middel per 100 liter water)

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Toepassingsgebied Type toepassing Te bestrijden Dosering Maximale Maximaal Minimum Veiligheidstermijn organisme (middel) dosering aantal interval in dagen per (middel) toepassingen tussen toepassing per per toepassingen toepassing teeltcyclus of in dagen per 12 maanden Bloemisterijgewassen Gewasbehandeling bladluis 22 0,075% 0,9 L/ha 2 per 12 14 - (bedekte, (75 ml maanden grondgebonden teelt) middel per 100 liter water) Boomkwekerijgewass Gewasbehandeling bladluis 0,075% 0,9 L/ha 2 per 12 14 - en (onbedekte teelt) na de bloei 1,4,21,22,24,26 (75 ml maanden middel per 100 liter water) Boomkwekerijgewass Gewasbehandeling bladluis 1, 21, 22, 24, 0,075% 0,75 L/ha 6 per 12 14 - en (bedekte, niet- 26, 37, 38 (75 ml maanden grond gebonden teelt) middel per 100 liter water) Boomkwekerijgewass Gewasbehandeling bladluis 1, 21, 22, 24, 0,075% 0,75 L/ha 2 per 12 14 - en (bedekte, 26, 37, 38 (75 ml maanden grondgebonden teelt) middel per 100 liter water) Vaste plantenteelt Gewasbehandeling bladluis 0,075% 0,75 L/ha 2 per 12 14 - (onbedekte teelt) op niet bloeiende 1,21,22,24,26,27 (75 ml maanden gewassen of na de middel per bloei 100 liter water)

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Toepassingsgebied Type toepassing Te bestrijden Dosering Maximale Maximaal Minimum Veiligheidstermijn organisme (middel) dosering aantal interval in dagen per (middel) toepassingen tussen toepassing per per toepassingen toepassing teeltcyclus of in dagen per 12 maanden Vaste plantenteelt Gewasbehandeling bladluis 1, 21, 22, 24, 0,075% 0,75 L/ha 6 per 12 14 - (bedekte, niet-grond 26, 39 (75 ml maanden gebonden teelt) middel per 100 liter water) Vaste plantenteelt Gewasbehandeling bladluis 1, 21, 22, 24, 0,075% 0,75 L/ha 2 per 12 14 - (bedekte, 26, 39 (75 ml maanden grondgebonden teelt) middel per 100 liter water) 1. Aardappeltopluis ( Macrosiphum euphorbiae ) 2. Wegedoornluis ( Aphis nasturtii ) 3. Vuilboomluis ( Aphis frangulae ) 4. Fluitekruidluis ( Dysaphis anthrisci ) 5. Kleine bramenluis (Aphis ruborum) 6. Appelgrasluis (Rhopalosiphum insertum) 7. Bloedvlekkenluis (Dysaphis devecta en D. anthrisci) 8. Roze appelluis (Dysaphis plantaginea) 9. Groene appeltakluis (Aphis pomi) 10. Appelbloedluis (Eriosoma lanigerum) 11. Roze pereluis (Dysaphis pyri) 12. Vouwgalluis (Anuraphis farfarae) 13. Zwarte perenluis (Melanaphis pyaria) 14. Perenbladvlo (Psylla pyri) 15. Zwarte kersenluis (Myzus cerasi). 16. Groene kortstaartluis (Brachycaudus helichrysi) 17. Melige perzikluis (Hyalopterus amygdali) 18. Melige pruimenluis (Hyalopterus pruni) 19. Wollige slawortelluis (Pemphigus bursarius)

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20. Groene slaluis (Nasanovia ribisnigri) 21. Groene perzikluis (Myzus persicae) 22. Katoenluis (Aphis gossypii) 23. Bruine slaluis (Uroleucon sonchi) 24. Zwarte bonenluis (Aphis fabae) 25. Gevlekte kortstaartluis (Brachycaudus prunicola) 26. Boterbloemluis (Aulacorthum solani) 27. Gele rozenluis (Rhodobium porrosum) 28. Groene melkdistelluis ( Hyperomyzus lactucae ) 29. Grote frambozenluis ( Amphorophora idaei ) 30. Aardbeiknotshaarluis ( Chaetosiphon fragaefolii ) 31. Sjalottenluis ( Myzus ascalonicus ) 32. Tabakstrips ( Thrips tabaci ) 33. Braamgrasluis (Sitobion fragariae) 34. Grote bramenluis (Amphorophora rubi) 35. Bessentakluis (Rhopalosiphoninus ribesinus) 36. Kleine frambozenluis (Aphis idaei) 37. Beukenbladluis (Phyllaphis fagi) 38. Gele rozenluis (Rhodobium porrosum)

Het gebruik in de onbedekte teelt van kers, pruim, druif, braam- en framboosachtigen, rucola, kiemgroenten, baby leaves en sjalotten 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 Te bestrijden Dosering Maximale Maximaal Minimum Veiligheidstermijn organisme (middel) dosering aantal interval in dagen per (middel) toepassingen tussen toepassing per per teeltcyclus toepassing toepassing of per 12 en in dagen maanden Pruim Gewasbehandeling bladluis 16,17,18 0,075% (75 1,1 L/ha 2 per 12 14 21 (onbedekte teelt) na de bloei ml middel maanden per 100 liter water) Druif Gewasbehandeling bladluis 21 0,075% (75 0,75 L/ha 2 per 12 14 14 (onbedekte teelt) na de bloei ml middel maanden per 100 liter water) Braam- en Gewasbehandeling bladluis 0,75 L/ha 0,75 L/ha 2 per 12 14 - framboosachtigen na de oogst 5,25,28,29,33-36 maanden (Rubus spp.) (onbedekte teelt) Rucola Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (onbedekte teelt) maanden Kiemgroenten Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (onbedekte teelt) maanden Baby leaves Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 (onbedekte teelt) maanden Sjalotten Gewasbehandeling trips 32 0,75 L/ha 0,75 L/ha 4 per 7 7 (onbedekte teelt) teeltcyclus Aromatische Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 kruidgewassen op niet bloeiende maanden (onbedekte teelt) gewassen of na de bloei Medicinale Gewasbehandeling bladluis 20-23 0,75 L/ha 0,75 L/ha 2 per 12 14 7 kruidgewassen op niet bloeiende maanden (onbedekte teelt) gewassen of na de bloei 1. Aardappeltopluis ( Macrosiphum euphorbiae ) 2. Wegedoornluis ( Aphis nasturtii )

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3. Vuilboomluis ( Aphis frangulae ) 4. Fluitekruidluis (Dysaphis anthrisci ) 5. Kleine bramenluis (Aphis ruborum) 6. Appelgrasluis (Rhopalosiphum insertum) 7. Bloedvlekkenluis (Dysaphis devecta en D. anthrisci) 8. Roze appelluis (Dysaphis plantaginea) 9. Groene appeltakluis (Aphis pomi) 10. Appelbloedluis (Eriosoma lanigerum) 11. Roze pereluis (Dysaphis pyri) 12. Vouwgalluis (Anuraphis farfarae) 13. Zwarte perenluis (Melanaphis pyaria) 14. Perenbladvlo (Psylla pyri) 15. Zwarte kersenluis (Myzus cerasi) 16. Groene kortstaartluis (Brachycaudus helichrysi) 17. Melige perzikluis (Hyalopterus amygdali) 18. Melige pruimenluis (Hyalopterus pruni) 19. Wollige slawortelluis (Pemphigus bursarius) 20. Groene slaluis (Nasanovia ribisnigri) 21. Groene perzikluis (Myzus persicae) 22. Katoenluis (Aphis gossypii) 23. Bruine slaluis (Uroleucon sonchi) 24. Zwarte bonenluis (Aphis fabae) 25. Gevlekte kortstaartluis (Brachycaudus prunicola) 26. Boterbloemluis (Aulacorthum solani) 27. Gele rozenluis (Rhodobium porrosum) 28. Groene melkdistelluis ( Hyperomyzus lactucae ) 29. Grote frambozenluis ( Amphorophora idaei ) 30. Aardbeiknotshaarluis ( Chaetosiphon fragaefolii ) 31. Sjalottenluis ( Myzus ascalonicus ) 32. Tabakstrips ( Thrips tabaci ) 33. Braamgrasluis (Sitobion fragariae) 34. Grote bramenluis (Amphorophora rubi) 35. Bessentakluis (Rhopalosiphoninus ribesinus) 36. Kleine frambozenluis (Aphis idaei) 37. Staticobium limonii (Staticobium limonii) 38. Beukenbladluis (Phyllaphis fagi)

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Toepassingsvoorwaarden Behandelde medicinale kruidgewassen alleen gebruiken voor homeopathische of medicinale doeleinden.

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 op plaatsen waar bijen actief naar voedsel zoeken. Gebruik dit product niet wanneer bloeiende onkruiden aanwezig zijn. Gebruik dit product niet in de buurt van in bloei staand onkruid. Verwijder onkruid voordat het bloeit. Na een gewasbehandeling percelen nog minimaal twee weken vrijhouden van bloeiende onkruiden.

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.

Gevoeligheid gewassen Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden van bloembol- en bloemknolgewassen, bloemisterijgewassen, vaste plantenteelt en boomkwekerijgewassen 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).

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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 in support of the evaluation

Annex point Year Title Vertebrat Data Data Studies Justification Owner Source (where different from e study protectio protection relied on if data company) Y/N n granted Y/N protection is Company, Report No. claimed Y/N claimed GLP or GEP status (where relevant) Y/N Published or Unpublished KIIIA 2.1 /01 2011 Physical, chemical and technical No Yes Y Y GLP report Bayer CropScience KIIIA 2.4.2 /01 properties of spirotetramat SC 100 (100 necessary for KIIIA 2.5.1 /01 g/L) first KIIIA 2.5.2 /01 Bayer CropScience, authorization KIIIA 2.5.3 /01 Report No.: FM0097(PC00)G01, KIIIA 2.6.1 /01 Edition Number: M-408624-01-1 KIIIA 2.8.2 /03 Date: 2011-05-23 KIIIA 2.8.3.1 /03 GLP/GEP: yes, unpublished KIIIA 2.8.3.2 /03 KIIIA 2.8.5.2 /01 KIIIA 2.8.6.1 /01 KIIIA 2.8.8.2 /01 KIIIA 2.2.1 /01 2011 Safety relevant technical properties of No Yes Y Y GLP report Bayer CropScience KIIIA 2.2.2 /01 spirotetramat SC 100 (100 g/L) - Final necessary for KIIIA 2.3.1 /01 report - first KIIIA 2.3.3 /01 Bayer CropScience, authorization Report No.: FF0093(SA00)G01, Edition Number: M-406653-01-1 Date: 2011-04-21 GLP/GEP: no, unpublished

KIIIA 2.7.1 /01 2007 Storage stability and shelf life of No No N Y - Bayer CropScience KIIIA 2.7.3 /01 spirotetramat SC 100 (100 g/L) - KIIIA 2.7.4 /01 [Packaging material: HDPE] - Final KIIIA 2.7.5 /01 report Bayer CropScience, Report No.: 2007-005473-01, Edition Number: M-293894-02-1 Date: 2007-10-09 ...Amended: 2009-11-25 GLP/GEP: no, unpublished

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Annex point Year Title Vertebrat Data Data Studies Justification Owner Source (where different from e study protectio protection relied on if data company) Y/N n granted Y/N protection is Company, Report No. claimed Y/N claimed GLP or GEP status (where relevant) Y/N Published or Unpublished KIIIA 2.7.1 /02 2010 Storage stability of spirotetramat SC No No N Y - Bayer CropScience KIIIA 2.7.3 /02 100 (100 g/L) - [Packaging material: KIIIA 2.7.5 /02 HDPE] - Interim report (2 weeks) KIIIA 2.8.2 /02 Bayer CropScience, KIIIA 2.8.3.1 /02 Report No.: 2010-005085-01, KIIIA 2.8.3.2 /02 Edition Number: M-396687-01-1 Date: 2010-11-30 GLP/GEP: no, unpublished KIIIA 2.7.1 /03 2011 Storage stability of spirotetramat SC No No N Y - Bayer CropScience KIIIA 2.7.3 /03 100 (100 g/L) - [Packaging material: KIIIA 2.7.4 /02 COEX/EVOH] - Interim report (2 weeks) KIIIA 2.7.5 /03 Bayer CropScience, Report No.: FM0097(AC03)N01, Edition Number: M-408620-01-1 Date: 2011-05-24 GLP/GEP: no, unpublished KIIIA 2.7.5 /04 2013 Storage stability and shelf life of No No N Y - Bayer CropScience spirotetramat SC 100 (100 g/L) - Packaging material: COEX/EVOH - Final report (2 years) Bayer CropScience, Report No.: FM0097(SLF03)N01, Edition Number: M-457642-01-1 Date: 2013-06-24 GLP/GEP: no, unpublished KIIIA 2.7.5 /05 2013 Storage stability and shelf life of No No N Y - Bayer CropScience spirotetramat SC 100 (100 g/L) - Packaging material: HDPE - Final report (2 years) Bayer CropScience, Report No.: FM0097(SLF01)N01, Edition Number: M-457643-01-1 Date: 2013-06-27 GLP/GEP: no, unpublished

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Annex point / Year Title Data protection Data protection Studies relied Owner reference Source (where different from company) claimed granted on Y/N number Company name, Report No., Date, GLP/GEP status Y/N Y/N (where relevant), published or not KIIIA 4.2.2 /01 2008 Summary and conclusive report of studies on spray tank No No Y Bayer Crop cleaning realized in the years 2000 - 2008 Scioence Bayer CropScience, Report No.: M-357166-01-1, Edition Number: M-357166-01-1 GLP/GEP: n.a., unpublished

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Annex Year Title Vertebrat Data Data Studies Owner point Source (where different from e study protectio protectio relied on company) Y/N n n granted Y/N Company, Report No. claimed Y/N GLP or GEP status (where relevant) Y/N Published or Unpublished KIIIA 5.2.1 /01 2004 Determination of Spirotetramat in formulations - assay - HPLC, external standard Bayer CropScience, Report No.: AM002104MF2, N N N Y Bayer CropScience Edition Number: M-068817-02-2 Date: 2004-05-11 ...Amended: 2004-05-11 Non GLP, unpublished KIIIA 5.2.1 /02 2010 Validation of HPLC-method AM002104MF2 - Determination of spirotetramat in formulations - spirotetramat SC 100 (100 g/L) N N N Y Bayer CropScience Bayer CropScience, Report No.: VB4-AM002104MF2, Edition Number: M-364023-01-1 Date: 2010-02-22 Non GLP, unpublished KIIIA 5.3.1 /01 2012 Validation of the QuEChERS method for the determination of selected BCS analytes and their metabolites in carrot, apple, orange, oilseed rape seed and beans Eurofins Agroscience Services N Y Y Y Bayer CropScience 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

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Annex point / Year Title Data Owner Data Study relied reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , Y/N published or not KIIIA 7.1.1 /01 2007 Spirotetramat SC 100 G - Acute oral Yes Bayer Y Y toxicity in the rat after oral CropScience administration Report No.: AT04251, Edition Number: M-294688-01-1 Date: 2007-11-20 GLP/GEP: yes, unpublished KIIIA 7.1.2 /01 2007 Spirotetramat SC 100 G - Acute Yes Bayer Y Y toxicity in the rat after dermal CropScience application Report No.: AT04250, Edition Number: M-294706-01-1 Date: 2007-11-20 GLP/GEP: yes, unpublished KIIIA 7.1.3 /01 2008 Spirotetramat SC 100 G - Acute Yes Bayer Y Y inhalation toxicity in rats CropScience Report No.: AT04410, Edition Number: M-297931-01-1 Date: 2008-02-22 GLP/GEP: yes, unpublished KIIIA 7.1.4 /01 2007 Spirotetramat SC 100 G - Acute skin Yes Bayer Y Y irritation/corrosion on rabbits CropScience Report No.: AT04312, Edition Number: M-295941-01-1 Date: 2007-12-11 GLP/GEP: yes, unpublished KIIIA 7.1.5 /01 2007 Spirotetramat SC 100 G - Acute eye Yes Bayer Y Y irritation on rabbits CropScience Report No.: AT04313, Edition Number: M-295927-01-1 Date: 2007-12-11 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study relied reference number Source (where different from company) protect. protection on Company name, Report No., Date, claimed granted Y/N GLP/GEP status (where relevant) , Y/N published or not KIIIA 7.1.6 /01 2010 Spirotetramat SC 100 G - Study for Yes Bayer Y Y the skin sensitization effect in guinea CropScience pigs (Buehler Patch Test) Report No.: AT06052, Edition Number: M-390603-01-1 Date: 2010-09-24 GLP/GEP: yes, unpublished KIIIA 7.5.1 /01 2014 Determination of the dislodgeable Yes Bayer Y Y foliar residues (DFR) of BYI 08330 CropScience in/on apple after spraying of spirotetramat SC 100 in the field in the Netherlands Bayer CropScience, Report No.: 14-2900, Report includes Trial Nos.: 14-2900-01 Edition Number: M-495936-01-1 Date: 2014-09-08 GLP/GEP: yes, unpublished KIIIA 7.6.2 /01 2013 Spirotetramat SC 100: spirotetramat - Yes Bayer Y Y In vitro dermal absorption study using CropScience human skin Bayer S.A.S., Bayer CropScience, Sophia Antipolis, France Bayer CropScience, Report No.: SA 13039, Edition Number: M-462668-01-1 Date: 2013-08-26 GLP/GEP: yes, unpublished

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Annex point Year Title Vertebrat Data Data Data used Owner / reference Source (where different from e study protect. protection for number company) Y/N claimed granted evaluatio Company name, Report Y/N n No., Date, GLP/GEP status (where relevant) , published or not KIIIA 2015 Determination of the N Yes Y Yes Bayer CropScience 8.3.6/01 residues of BYI 08330 in/on 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 2015 Determination of the N Yes Y Yes Bayer CropScience 8.3.6/02 residues of BYI 08330 in/on 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

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Annex point Year Title Vertebrat Data Data Data used Owner / reference Source (where different from e study protect. protection for number company) Y/N claimed granted evaluatio Company name, Report Y/N n No., Date, GLP/GEP status (where relevant) , published or not KIIIA 8.3.7. 2013 Determination of the N Yes y Yes Bayer CropScience /01 residues of spirotetramat 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. 2012 Residues of spirotetramat in N Yes Y Yes Bayer CropScience /02 red currant under 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 Vertebrat Data Data Data used Owner / reference Source (where different from e study protect. protection for number company) Y/N claimed granted evaluatio Company name, Report Y/N n No., Date, GLP/GEP status (where relevant) , published or not KIIIA 8.3.7. 2012 Residues of spirotetramat in N Yes Y Yes Bayer CropScience /03 red currant under plastic umbrella at intervals following two foliar applications of spirotetramat 100 SC - Netherlands, season 2011 Proeftuin Zwaagdijk, Zwaagdijk, Netherlands Bayer CropScience, Report No.: PTZ-NLI- 11794, Edition Number: M-434292- 01-1 Date: 2012-07-02 GLP/GEP: yes, unpublished KIIIA 8.3.7. 2012 Residues of spirotetramat in N Yes Y Yes Bayer CropScience /04 red currant under plastic umbrella at intervals following two foliar applications of spirotetramat 100 SC - Netherlands, season 2011 Proeftuin Zwaagdijk, Zwaagdijk, Netherlands Bayer CropScience, Report No.: PTZ-NLI- 11795, Edition Number: M-434297- 01-1 Date: 2012-07-02 GLP/GEP: yes, unpublished

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Annex point Year Title Vertebrat Data Data Data used Owner / reference Source (where different from e study protect. protection for number company) Y/N claimed granted evaluatio Company name, Report Y/N n No., Date, GLP/GEP status (where relevant) , published or not KIIIA 8.3.8 2014 Determination of the N Yes Y Yes Bayer CropScience /02 residues of spirotetramat 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 8.3.15/01 2014 Determination of residues N Yes Y Yes Bayer CropScience of spirotetramat and 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

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Annex point Year Title Vertebrat Data Data Data used Owner / reference Source (where different from e study protect. protection for number company) Y/N claimed granted evaluatio Company name, Report Y/N n No., Date, GLP/GEP status (where relevant) , published or not 8.3.15/02 2015 Determination of the N Yes Y Yes Bayer CropScience residues of BYI 08330 in/on 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 2009 Determination of the N Yes Y Yes Bayer CropScience /01 residues of BYI 08330 in/on 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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Annex point Year Title Vertebrat Data Data Data used Owner / reference Source (where different from e study protect. protection for number company) Y/N claimed granted evaluatio Company name, Report Y/N n No., Date, GLP/GEP status (where relevant) , published or not KIIIA 8.5.3 2014 Determination of the N Yes Y Yes Bayer CropScience /01 residues of spirotetramat in/on potato and the processed fractions (tuber, washed; washings; peel washed; tuber, peeled; tuber, cooked; cooking water; potato, fried; tuber, blanched; blanching water; French fries (Br.: chips); tuber, baked; peel rest; tuber, baked, peeled; tuber, microwaved; fibre; pulp, dry; concentrate; starch; waste; peeling water; waste, dried; tuber, steamed, mashed; flakes; slices, washed and crisps (Am.: chips)) after spraying of spirotetramat SC 100 in the field in Germany Report No.: 13-3410, Report includes Trial Nos.: 13-3410-01 Edition Number: M-493680- 01-1 Date: 2014-08-12 GLP/GEP: yes, unpublished

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.4 /01 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsoil EUR CropScience - Use in field crops, fruit trees and vines in Europe Bayer CropScience, Report No.: EnSa-14- 0342, Edition Number: M- 487184-01-1 Date: 2014-03-24 GLP/GEP: no, unpublished ...also filed: KIIIA 9.5 /01 KIIIA 9.4 /02 2012 SPT core PECsoil EU: N No N Yes Bayer Modelling core info CropScience document for soil risk assessment in Europe Bayer CropScience, Report No.: EnSa-12- 0503, Edition Number: M- 441731-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.5 /02

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.5 /01 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsoil EUR CropScience - Use in field crops, fruit trees and vines in Europe Bayer CropScience, Report No.: EnSa-14- 0342, Edition Number: M- 487184-01-1 Date: 2014-03-24 GLP/GEP: no, unpublished ...also filed: KIIIA 9. 4 /01 KIIIA 9.5 /02 2012 SPT core PECsoil EU: N No N Yes Bayer Modelling core info CropScience document for soil risk assessment in Europe Bayer CropScience, Report No.: EnSa-12- 0503, Edition Number: M- 441731-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.4 /02

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.6.1 /01 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECgw CropScience FOCUS PEARL, PELMO EUR - Use in citrus and olives, pome and stone fruits, hops, vines and berries in Europe Bayer CropScience, Report No.: EnSa-14- 0351, Edition Number: M- 492213-01-1 Date: 2014-03-27 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /01 KIIIA 9.6.1 /02 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECgw CropScience FOCUS PEARL, PELMO EUR - Use in cabbage, flowerbulbs, onions and peas in Europe Bayer CropScience, Report No.: EnSa-14- 0357, Edition Number: M- 492243-01-1 Date: 2014-03-27 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /02

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.6.1 /04 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECgw CropScience FOCUS PEARL, PELMO EUR - Use in beans, herbs, floriculture and strawberries in Europe Bayer CropScience, Report No.: EnSa-14- 0362, Edition Number: M- 492246-01-1 Date: 2014-03-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /04 KIIIA 9.6.1 /05 2012 SPT core PECgw EU: N No N Yes Bayer Modelling core info CropScience document for groundwater risk assessment in Europe Bayer CropScience, Report No.: EnSa-12- 0502, Edition Number: M- 441721-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /05

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.6.2 /01 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECgw CropScience FOCUS PEARL, PELMO EUR - Use in citrus and olives, pome and stone fruits, hops, vines and berries in Europe Bayer CropScience, Report No.: EnSa-14- 0351, Edition Number: M- 492213-01-1 Date: 2014-03-27 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /01 KIIIA 9.6.2 /02 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECgw CropScience FOCUS PEARL, PELMO EUR - Use in cabbage, flowerbulbs, onions and peas in Europe Bayer CropScience, Report No.: EnSa-14- 0357, Edition Number: M- 492243-01-1 Date: 2014-03-27 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /02

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.6.2 /04 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECgw CropScience FOCUS PEARL, PELMO EUR - Use in beans, herbs, floriculture and strawberries in Europe Bayer CropScience, Report No.: EnSa-14- 0362, Edition Number: M- 492246-01-1 Date: 2014-03-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /04 KIIIA 9.6.2 /05 2012 SPT core PECgw EU: N No N Yes Bayer Modelling core info CropScience document for groundwater risk assessment in Europe Bayer CropScience, Report No.: EnSa-12- 0502, Edition Number: M- 441721-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /05

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.7 /01 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in pome and stone fruits and tree nursery in Europe Bayer CropScience, Report No.: EnSa-14- 0332, Edition Number: M- 487167-01-1 Date: 2014-03-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /01 KIIIA 9.7 /02 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in hops, vines and currants in Europe Bayer CropScience, Report No.: EnSa-14- 0331, Edition Number: M- 487163-01-1 Date: 2014-03-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /02

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.7 /03 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in leafy vegetables, cabbages and kale, turnip in Europe Bayer CropScience, Report No.: EnSa-14- 0334, Edition Number: M- 487180-01-1 Date: 2014-03-21 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /03 KIIIA 9.7 /04 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in bulb vegetables, strawberries and brussels sprouts in Europe Bayer CropScience, Report No.: EnSa-14- 0333, Edition Number: M- 487176-01-1 Date: 2014-04-08 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /04

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.7 /05 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in field beans, legumes, potatoes and ornamental plants in Europe Bayer CropScience, Report No.: EnSa-14- 0330, Edition Number: M- 487159-01-1 Date: 2014-03-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /05 KIIIA 9.7 /06 2012 SPT core PECsw EU: N No N Yes Bayer Modelling core info CropScience document for surface water risk assessment in Europe Bayer CropScience, Report No.: EnSa-12- 0504, Edition Number: M- 441745-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /06

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.8 /01 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in pome and stone fruits and tree nursery in Europe Bayer CropScience, Report No.: EnSa-14- 0332, Edition Number: M- 487167-01-1 Date: 2014-03-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /01 KIIIA 9.8 /02 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in hops, vines and currants in Europe Bayer CropScience, Report No.: EnSa-14- 0331, Edition Number: M- 487163-01-1 Date: 2014-03-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /0 2

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.8 /03 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in leafy vegetables, cabbages and kale, turnip in Europe Bayer CropScience, Report No.: EnSa-14- 0334, Edition Number: M- 487180-01-1 Date: 2014-03-21 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /03 KIIIA 9.8 /04 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in bulb vegetables, strawberries and brussels sprouts in Europe Bayer CropScience, Report No.: EnSa-14- 0333, Edition Number: M- 487176-01-1 Date: 2014-04-08 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /04

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Core Assessment Annex point Year Title Vertebrate Data Data Data used Owner Source (where different study protect. protection for from company) Y/N claimed granted Y/N evaluation Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 9.8 /05 2014 Spirotetramat (SPT) and N No N Yes Bayer metabolites: PECsw,sed CropScience FOCUS EUR - Use in field beans, legumes, potatoes and ornamental plants in Europe Bayer CropScience, Report No.: EnSa-14- 0330, Edition Number: M- 487159-01-1 Date: 2014-03-19 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /05 KIIIA 9.8 /06 2012 SPT core PECsw EU: N No N Yes Bayer Modelling core info CropScience document for surface water risk assessment in Europe Bayer CropScience, Report No.: EnSa-12- 0504, Edition Number: M- 441745-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /06

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National Addendum KIIIA 9.6.1 /01 2014 Spirotetramat (SPT) PECgw NL: N No N Y Bayer Predicted environmental CropScience concentrations in groundwater based GeoPEARL 3.3.3 - Use in several arable crops, fruits and trees in the Netherlands - Spirotetramat (BYI 08330) - BYI08330-enol (BCS-AR12397) - BYI08330-methoxy cyclohexanone (AE 1302938) - BYI08330- ketohydroxy (AE 1422479) - BYI08330-MA-amide (AE 1786350) Bayer CropScience, Report No.: EnSa-14-0510, Edition Number: M-489877-01-1 Date: 2014-06-02 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /01 KIIIA 9.6.1 /02 2012 SPT core PECgw EU: Modelling N No N Y Bayer core info document for groundwater CropScience risk assessment in Europe Bayer CropScience, Report No.: EnSa-12-0502, Edition Number: M-441721-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2 /02

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KIIIA 9.6.2 /01 2014 Spirotetramat (SPT) PECgw NL: N No N Y Bayer Predicted environmental CropScience concentrations in groundwater based GeoPEARL 3.3.3 - Use in several arable crops, fruits and trees in the Netherlands - Spirotetramat (BYI 08330) - BYI08330-enol (BCS-AR12397) - BYI08330-methoxy cyclohexanone (AE 1302938) - BYI08330- ketohydroxy (AE 1422479) - BYI08330-MA-amide (AE 1786350) Bayer CropScience, Report No.: EnSa-14-0510, Edition Number: M-489877-01-1 Date: 2014-06-02 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /01 KIIIA 9.6.2 /02 2012 SPT core PECgw EU: Modelling N No N Y Bayer core info document for groundwater CropScience risk assessment in Europe Bayer CropScience, Report No.: EnSa-12-0502, Edition Number: M-441721-03-1 Date: 2012-11-14 ...Amended: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1 /02

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KIIIA 9.7 /01 2014 Spirotetramat (SPT) and N No N Y Bayer metabolites NL: Predicted CropScience environmental concentrations in surface water (PECsw) and sediment (PECsed) based on calculations with TOXSWA - Use in fruit crops (soft and large), bulbs, field crops and in greenhouse - Spirotetramat (BYI 08330) - BYI08330-enol (BCS-AR12397) - BYI08330-ketohydroxy (AE 1422479) - BYI08330-methoxy cyclohexanone (AE 1302938) - BYI08330-methoxy cyclohexylamino carboxylic acid (BCS-AA10277) Bayer CropScience, Report No.: EnSa-14-0464, Edition Number: M-489872-01-1 Date: 2014-04-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /01 KIIIA 9.7 /02 2014 Spirotetramat core PECsw: N No N Y Bayer Modelling core info document for CropScience surface water risk assessment in the Netherland Bayer CropScience, Report No.: EnSa-14-0304, Edition Number: M-480889-01-1 Date: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /02

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KIIIA 9.8 /01 2014 Spirotetramat (SPT) and N No N Y Bayer metabolites NL: Predicted CropScience environmental concentrations in surface water (PECsw) and sediment (PECsed) based on calculations with TOXSWA - Use in fruit crops (soft and large), bulbs, field crops and in greenhouse - Spirotetramat (BYI 08330) - BYI08330-enol (BCS-AR12397) - BYI08330-ketohydroxy (AE 1422479) - BYI08330-methoxy cyclohexanone (AE 1302938) - BYI08330-methoxy cyclohexylamino carboxylic acid (BCS-AA10277) Bayer CropScience, Report No.: EnSa-14-0464, Edition Number: M-489872-01-1 Date: 2014-04-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /01 KIIIA 9.8 /02 2014 Spirotetramat core PECsw: N No N Y Bayer Modelling core info document for CropScience surface water risk assessment in the Netherland Bayer CropScience, Report No.: EnSa-14-0304, Edition Number: M-480889-01-1 Date: 2014-03-12 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /02 Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.1.2 /01 2014 Spirotetramat SC 100 G - Yes Bayer Y Yes Higher tier risk assessment for CropScience birds (long-term) (uses in the Central zone) Bayer CropScience, Report No.: M-494716-01-1, Edition Number: M-494716- 01-1 Date: 2014-08-20 GLP/GEP: n.a., unpublished KIIIA 10.1.7 /01 2006 Bird species in modern pome No BASF N Yes fruit orchards in Germany: field data for the determination of focal species Report No.: RA03-006, Edition Number: M-291198- 01-1 Date: 2006-12-31 GLP/GEP: no, unpublished KIIIA 10.1.7 /04 2007 Generic field monitoring of Yes BASF Y Yes selected bird species in orchards in Southern Germany Report No.: 218044, Edition Number: M-291211- 01-1 Date: 2007-04-23 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.1.7 /06 2012 Residues of spirotetramat in Yes Bayer Y Yes arthropods after spray CropScience 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 /07 2004 Generic field monitoring of birds Yes Bayer Y Yes and mammals in hop-cultivation CropScience in Southern Germany Bayer CropScience, Report No.: WFC/FS 009, Edition Number: M-123479- 01-1 Date: 2004-11-12 GLP/GEP: yes, unpublished KIIIA 10.1.7 /08 2008 Half-life of spirotetramat No Bayer N Yes residues on crops (lettuce) CropScience Bayer CropScience, Report No.: M-312080-01-1, Edition Number: M-312080- 01-1 Date: 2008-12-01 GLP/GEP: n.a., unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.1.7 /09 2008 Generic monitoring of birds in No Syngenta N Yes vegetable fields in Great Britain Germany Report No.: R07-034, Edition Number: M-302416- 01-1 Date: 2008-06-02 GLP/GEP: yes, unpublished KIIIA 10.2.2 /01 2008 Acute toxicity of spirotetramat Yes Bayer Y Yes SC 100 G to larvae of CropScience Chironomus riparius in a static 48-hour immobilization test IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 37822250, Edition Number: M-300921- 01-1 Date: 2008-04-24 GLP/GEP: yes, unpublished KIIIA 10.2.2.1 2007 Acute toxicity of spirotetramat Yes Bayer Y Yes /01 SC 100 G to rainbow trout CropScience (Oncorhynchus mykiss) in a 96- hour static test Report No.: 37823230, Edition Number: M-296679- 01-1 Date: 2007-12-21 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.2.2.3 2008 Toxicity of Spirotetramat SC Yes Bayer Y Yes /01 100 G to Pseudokirchneriella CropScience subcapitata in an algal growth inhibition test Report No.: 37821210, Edition Number: M-300803- 01-1 Date: 2008-04-22 GLP/GEP: yes, unpublished KIIIA 10.4.2.1 2008 Effects of Spirotetramat SC 100 Yes Bayer Y Yes /01 G (acute contact and oral) on CropScience honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 34251035, Edition Number: M-298419- 01-1 Date: 2008-02-07 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.4.5 /02 2012 A multi-rate field study to Yes Bayer Y Yes evaluate potential effects on CropScience 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 /02 2009 Effects of Spirotetramat OD No Bayer N Yes 150 (Movento) on honeybees in CropScience 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 GLP/GEP: no, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.4.7 /03 2010 Effects of an application of Yes Bayer Y Yes Spirotetramat SC 100 to CropScience 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 10.5.2 /01 2007 Toxicity to the parasitoid wasp Yes Bayer Y Yes Aphidius rhopalosiphi CropScience (DESTEPHANI-PEREZ) (Hymenoptera: Braconidae) using an extended laboratory test Spirotetramat SC 100 G Bayer CropScience, Report No.: CW07/060, Edition Number: M-295413- 01-1 Date: 2007-12-10 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.5.2 /02 2007 Toxicity to the predatory mite Yes Bayer Y Yes Typhlodromus pyri SCHEUTEN CropScience (Acari, Phytoseiidae) using an extended laboratory test Spirotetramat SC 100 G Bayer CropScience, Report No.: CW07/059, Edition Number: M-294615- 01-1 Date: 2007-11-20 GLP/GEP: yes, unpublished KIIIA 10.5.2 /03 2007 Toxicity to the green lacewing Yes Bayer Y Yes Chrysoperla carnea STEPH. CropScience (Neuroptera, Chrysopidae) using an extended laboratory test (including food-application) Spirotetramat SC 100 G Bayer CropScience, Report No.: CW07/061, Edition Number: M-295417- 01-1 Date: 2007-12-10 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.5.2 /04 2007 Toxicity to the ladybird beetle Yes Bayer Y Yes Coccinella septempunctata L. CropScience (Coleoptera, Coccinellidae) using an extended laboratory test including exposure to and oral uptake of Spirotetramat SC 100 G Bayer CropScience, Report No.: CW07/063, Edition Number: M-295422- 01-1 Date: 2007-12-10 GLP/GEP: yes, unpublished KIIIA 10.5.3 /01 2014 Toxicity to the predatory mite Yes Bayer Y Yes Typhlodromus pyri (Acari: CropScience 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

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.6.3 /01 2014 Spirotetramat SC 100 G: Yes Bayer Y Yes Effects on reproduction and CropScience growth of earthworms Eisenia fetida in artificial soiI IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 86923022, Edition Number: M-480006- 01-1 Date: 2014-03-11 GLP/GEP: yes, unpublished KIIIA 10.6.6 /01 2014 Spirotetramat SC 100 G: Yes Bayer Y Yes Effects on reproduction of the CropScience collembola Folsomia candida in artificial soil IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 86921016, Edition Number: M-490683- 01-1 Date: 2014-06-06 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.6.6 /02 2014 Spirotetramat SC 100 G: Yes Bayer Y Yes Effects on reproduction of the CropScience predatory mite Hypoaspis aculeifer in artificial soil IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 86922089, Edition Number: M-482105- 01-1 Date: 2014-03-21 GLP/GEP: yes, unpublished KIIIA 10.7.1 /01 2014 Spirotetramat SC 100 G: Yes Bayer Y Yes Effects on the activity of soil CropScience microflora (nitrogen transformation test) BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 14 10 48 016 N, Edition Number: M-484252- 01-1 Date: 2014-04-15 GLP/GEP: yes, unpublished

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Annex point / Year Title Data Owner Data Study used reference Source (where different from protect protection for number company) ion granted evaluation Company name, Report No., claime Y/N Yes/No Date, GLP/GEP status (where d relevant) , published or not KIIIA 10.8.1.2 2007 Non-target terrestrial plants: an No Bayer N Yes /01 evaluation of the effects of CropScience Spirotetramat SC 100 g/L in the vegetative vigour test (Tier 1) Bayer CropScience, Report No.: VV07/054, Edition Number: M-295715- 01-1 Date: 2007-12-19 GLP/GEP: no, unpublished KIIIA 10.8.1.2 2008 Spirotetramat SC 100 g/L effect Yes Bayer Y Yes /02 on the vegetative vigour of the CropScience non-target terrestrial plant corn Bayer CropScience, Report No.: VV07/054, Edition Number: M-299193- 01-1 Date: 2008-03-18 GLP/GEP: yes, unpublished KIIIA 10.8.1.3 2008 Non-target terrestrial plants: an No Bayer N Yes /01 evaluation of the effects of CropScience Spirotetramat SC 100 g/L in the seedling emergence and growth test (Tier 1) Bayer CropScience, Report No.: SE07/053, Edition Number: M-298477- 01-1 Date: 2008-03-06 GLP/GEP: no, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6 /01 2008 Biological study - Movento 100 SC (spirotetramat 100 g/L) - On Psylla pyri, No No Y Bayer Eriosoma lanigerum, Lepidosaphes ulmi, Dysaphis plantaginea, Aphis pomi, CropScience and Dasineura species, in pome fruits - On Phllaphis fagim Trialeurodes vaporariorum, Psylla species, Aphids specied, Scales species, and Midges species, in ornamentals outdoor Bayer CropScience Bayer CropScience, Report No.: BBD-08-11, Edition Number: M-353069-01-1 Date: 2008-10-24 GLP/GEP: n.a., unpublished KIIIA 6 /02 2008 Biological study - Movento 100 SC (spirotetramat 100 g/L) - On Brevicoryne No No Y Bayer brassicae, Myzus persicae, and Aleyrodes proletella in cabbages - On CropScience Nasonovia ribisnigri, Myzus persicae, and Pemphigus bursarius in lettuces Bayer CropScience Bayer CropScience, Report No.: BBD-08-12, Edition Number: M-353072-01-1 Date: 2008-10-24 GLP/GEP: n.a., unpublished KIIIA 6 /03 2013 Compilation of documents for SPT SC100 (spirotetramat 100 g/L) - Annexes Yes Yes Y Bayer of the biological assessment dossier - BBD-08-11 - Annexes 1-20 - KIIIA 6 CropScience Bayer CropScience Bayer CropScience, Report No.: M-464395-01-1, Edition Number: M-464395-01-1 Date: 2013-09-06 GLP/GEP: yes, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6 /04 2013 Compilation of documents for SPT SC100 (spirotetramat 100 g/L) - Annexes Yes Yes Y Bayer of the biological assessment dossier - BBD-08-12 - Annexes 1-16 - KIIIA 6 CropScience Bayer CropScience Bayer CropScience, Report No.: M-464402-01-1, Edition Number: M-464402-01-1 Date: 2013-09-06 GLP/GEP: yes, unpublished KIIIA 6 /05 2013 Summary of the efficacy data and information on the plant protection product No No Y Bayer for spirotetramat SC100 CropScience Bayer CropScience Bayer CropScience, Report No.: M-437104-02-1, Edition Number: M-437104-02-1 Date: 2013-04-30 GLP/GEP: n.a., unpublished KIIIA 6 /06 2013 Registration report - Part B - Section 7: Efficacy data and information - No No Y Bayer Detailed summary - Spirotetramat SC 100 (100 g/L) - Central zone - Zonal CropScience 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 KIIIA 6 /07 2014 Summary of efficacy data and information on the plant protection product for No No Y Bayer Spirotetramat SC100 (100 g/L) - Central Zone CropScience Bayer CropScience Bayer CropScience, Report No.: M-498881-01-1, Edition Number: M-498881-01-1 Date: 2014-10-17 GLP/GEP: n.a., unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1 2008 Movento product development: Custom-made formulations for an exceptional No No Y /01 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, fecundity and fertility of Frankliniella No No Y Bayer /01 occidentalis CropScience 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 reports for spirotetramat - Minimum effective dose and Yes Yes Y Bayer /01 efficacy trials on strawberries CropScience Bayer CropScience Bayer CropScience, Report No.: M-491753-02-1, Edition Number: M-491753-02-1 Date: 2014-07-14 ...Amended: 2014-07-25 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /11 ...also filed: KIIIA 6.2.1 /09

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1.2 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /02 and efficacy trials on cherry fruit fly Rhagoletis cerasi in sweet cherry - CropScience Maritime climate zone Bayer CropScience Bayer CropScience, Report No.: M-493004-01-1, Edition Number: M-493004-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /03 ...also filed: KIIIA 6.2.1 /04 KIIIA 6.1.2 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /03 and efficacy trials on black cherry aphid Myzus cerasi in sweet and sour CropScience cherries - Maritime and South-East climate zones Bayer CropScience Bayer CropScience, Report No.: M-493231-01-1, Edition Number: M-493231-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /04 ...also filed: KIIIA 6.2.1 /05 KIIIA 6.1.2 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /04 and efficacy trials on mealy plum aphid Hyalopterus pruni in plum - Maritime CropScience and South-East climate zones Bayer CropScience Bayer CropScience, Report No.: M-493233-01-1, Edition Number: M-493233-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /05 ...also filed: KIIIA 6.2.1 /06

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1.2 2014 Compilation of trial report for SPT SC100 and SPT OD150 - spirotetramat Yes Yes Y Bayer /05 SC100 (100 g/L); spirotetramat OD150 (150 g/L) - Efficacy trials against CropScience 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 /14 ...also filed: KIIIA 6.2.1 /10 ...also filed: KIIIA 6.2.5 /01 KIIIA 6.1.2 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /06 and efficacy trials on onion thrips Thrips tabaci - Maritime climate zone CropScience (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 /07 ...also filed: KIIIA 6.2.1 /12 KIIIA 6.1.2 2014 Compilation of trial report for SPT SC 100 / SPT OD 150 - Spirotetramat SC Yes Yes Y Bayer /07 100 (100 g/L) - Spirotetramat OD 150 (150 g/L) - Efficacy trials - 8 trials (2006- CropScience 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 /09

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1.2 2014 Compilation of trial report for SPT SC 100 - Spirotetramat SC 100 (100 g/L) - Yes Yes Y Bayer /08 Efficacy trials - 7 trials (2012-2014) - Dasineura tetensis, Cecidophyopsis ribis, CropScience 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 ...also filed: KIIIA 6.1.3 /12 ...also filed: KIIIA 6.2.1 /13 KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat SC100 - Efficacy and plant safety Yes Yes Y Bayer /01 trials on pome fruits in the North-East (Poland) and Maritime (Denmark, CropScience Sweden) climate zones Bayer CropScience Bayer CropScience, Report No.: M-491756-01-1, Edition Number: M-491756-01-1 Date: 2014-07-16 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /01 KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat SC100 - Efficacy and plant safety Yes Yes Y Bayer /02 trials on cabbages in the South-East climate zone (Hungary) CropScience Bayer CropScience Bayer CropScience, Report No.: M-492738-01-1, Edition Number: M-492738-01-1 Date: 2014-07-22 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /02

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /03 and efficacy trials on cherry fruit fly Rhagoletis cerasi in sweet cherry - CropScience Maritime climate zone Bayer CropScience Bayer CropScience, Report No.: M-493004-01-1, Edition Number: M-493004-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /02 ...also filed: KIIIA 6.2.1 /04 KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /04 and efficacy trials on black cherry aphid Myzus cerasi in sweet and sour CropScience cherries - Maritime and South-East climate zones Bayer CropScience Bayer CropScience, Report No.: M-493231-01-1, Edition Number: M-493231-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /03 ...also filed: KIIIA 6.2.1 /05 KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /05 and efficacy trials on mealy plum aphid Hyalopterus pruni in plum - Maritime CropScience and South-East climate zones Bayer CropScience Bayer CropScience, Report No.: M-493233-01-1, Edition Number: M-493233-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /04 ...also filed: KIIIA 6.2.1 /06

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat SC100 - Efficacy trials on scales in Yes Yes Y Bayer /06 stone fruits - South-East climate zone CropScience Bayer CropScience Bayer CropScience, Report No.: M-493237-01-1, Edition Number: M-493237-01-1 Date: 2014-08-05 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /07 KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /07 and efficacy trials on onion thrips Thrips tabaci - Maritime climate zone CropScience (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 /06 ...also filed: KIIIA 6.2.1 /12 KIIIA 6.1.3 2011 Compilation of trial report for Movento - Spirotetramat OD 150 - Efficacy tests Yes Yes Y Bayer /08 onions CropScience 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 company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1.3 2014 Compilation of trial report for SPT SC 100 / SPT OD 150 - Spirotetramat SC Yes Yes Y Bayer /09 100 (100 g/L) - Spirotetramat OD 150 (150 g/L) - Efficacy trials - 8 trials (2006- CropScience 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 /07 KIIIA 6.1.3 2014 Compilation of trial report for spirotetramat - Efficacy trials on swede midge Yes Yes Y Bayer /10 Contarinia nasturtii in brassica crops - Maritime climate zone CropScience 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 reports for spirotetramat - Minimum effective dose and Yes Yes Y Bayer /11 efficacy trials on strawberries CropScience Bayer CropScience Bayer CropScience, Report No.: M-491753-02-1, Edition Number: M-491753-02-1 Date: 2014-07-14 ...Amended: 2014-07-25 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /01 ...also filed: KIIIA 6.2.1 /09

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.1.3 2014 Compilation of trial report for SPT SC 100 - Spirotetramat SC 100 (100 g/L) - Yes Yes Y Bayer /12 Efficacy trials - 7 trials (2012-2014) - Dasineura tetensis, Cecidophyopsis ribis, CropScience 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 ...also filed: KIIIA 6.1.2 /08 ...also filed: KIIIA 6.2.1 /13 KIIIA 6.1.3 2014 Compilation of trial report for SPT SC100 - Spirotetramat SC 100 (100 g/L) - Yes Yes Y Bayer /13 Efficacy trials in Poland against gall mite, aphids and midges in black currant CropScience Bayer CropScience Bayer CropScience, Report No.: M-491858-01-1, Edition Number: M-491858-01-1 Date: 2014-07-17 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /14 KIIIA 6.1.3 2014 Compilation of trial report for SPT SC100 and SPT OD150 - spirotetramat Yes Yes Y Bayer /14 SC100 (100 g/L); spirotetramat OD150 (150 g/L) - Efficacy trials against CropScience 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 /05 ...also filed: KIIIA 6.2.1 /10 ...also filed: KIIIA 6.2.5 /01

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 2013 Compilation of trial report for FPF SL200 - Flupyradifurone SL200 (200 g/L) - Yes Yes Y Bayer 6.1.4.1 /01 Impact of FPF SL200 on the quality of strawberry CropScience Bayer CropScience Bayer CropScience, Report No.: M-465469-01-1, Edition Number: M-465469-01-1 Date: 2013-07-25 GLP/GEP: yes, unpublished KIIIA 2014 Compilation of trial report for spirotetramat SC100 . Plant safety, yield and Yes Yes Y Bayer 6.1.4.1 /02 quality to host crop; strawberry CropScience Bayer CropScience Bayer CropScience, Report No.: M-491755-01-1, Edition Number: M-491755-01-1 Date: 2014-07-11 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.3 /02 ...also filed: KIIIA 6.2.1 /08 KIIIA 2014 Compilation of trial report for SPT SC 100 / SPT OD 150 - Spirotetramat SC Yes Yes Y Bayer 6.1.4.1 /03 100 (100 g/L) - Spirotetramat OD 150 (150 g/L) - Selectivity trials - 4 trials CropScience (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 /03 ...also filed: KIIIA 6.2.1 /11

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 2014 Compilation of trial report for SPT SC100 - Spirotetramat SC100 (100 g/L) - Yes Yes Y Bayer 6.1.4.2 /01 Effect of spirotetramat SC100 on cider processing and cider quality CropScience Bayer CropScience Bayer CropScience, Report No.: M-484563-01-1, Edition Number: M-484563-01-1 Date: 2014-04-29 GLP/GEP: yes, unpublished KIIIA 2007 Field trials for taint test sampling reports and taint test study reports Yes Yes Y Bayer 6.1.4.2 /02 compilation on pome fruits and stone fruits BYI 08330 150 g/L OD CropScience Bayer CropScience S.A., Lyon, France Bayer CropScience, Report No.: M-282681-01-1, Edition Number: M-282681-01-1 Date: 2007-01-22 GLP/GEP: yes, unpublished KIIIA 2014 Compilation of trial report for SPT OD150 - Spirotetramat OD150 (150 g/L) - Yes Yes Y Bayer 6.1.4.2 /03 Taint studies in potatoes CropScience 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 SC100 - Spirotetramat SC100 (100 g/L) - Yes Yes Y Bayer 6.1.4.2 /04 Taint studies in spinach CropScience Bayer CropScience Bayer CropScience, Report No.: M-479816-01-1, Edition Number: M-479816-01-1 Date: 2014-03-07 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /15

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 2014 Compilation of trial report for SPT SC100 - Spirotetramat SC100 (100 g/L) - Yes Yes Y Bayer 6.1.4.2 /05 Taint studies in onion CropScience 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 SC100 - Spirotetramat SC100 (100 g/L) - Yes Yes Y Bayer 6.1.4.2 /06 Taint studies in strawberry CropScience 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 SC100 - Spirotetramat SC100 (100 g/L) - Yes Yes Y Bayer 6.1.4.2 /07 Taint studies in black currant CropScience Bayer CropScience Bayer CropScience, Report No.: M-483940-01-1, Edition Number: M-483940-01-1 Date: 2014-04-16 GLP/GEP: yes, unpublished KIIIA 2010 Compilation of trial report for spirotetramat SC100 - Impact on the yield of host Yes Yes Y Bayer 6.1.4.3 /01 crop; Belgian endive - Trial IR08BELVON0420 CropScience Bayer CropScience N.V., Brussel, Belgium Bayer CropScience, Report No.: M-493544-01-1, Report includes Trial Nos.: IR08BELVON0420 Edition Number: M-493544-01-1 Date: 2010-01-05 GLP/GEP: yes, unpublished

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 2014 Compilation of trial report for spirotetramat SC100 . Plant safety, yield and Yes Yes Y Bayer 6.1.4.3 /02 quality to host crop; strawberry CropScience Bayer CropScience Bayer CropScience, Report No.: M-491755-01-1, Edition Number: M-491755-01-1 Date: 2014-07-11 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.1 /02 ...also filed: KIIIA 6.2.1 /08 KIIIA 2014 Compilation of trial report for SPT SC 100 / SPT OD 150 - Spirotetramat SC Yes Yes Y Bayer 6.1.4.3 /03 100 (100 g/L) - Spirotetramat OD 150 (150 g/L) - Selectivity trials - 4 trials CropScience (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 /03 ...also filed: KIIIA 6.2.1 /11 KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Efficacy and plant safety Yes Yes Y Bayer /01 trials on pome fruits in the North-East (Poland) and Maritime (Denmark, CropScience Sweden) climate zones Bayer CropScience Bayer CropScience, Report No.: M-491756-01-1, Edition Number: M-491756-01-1 Date: 2014-07-16 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 company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Efficacy and plant safety Yes Yes Y Bayer /02 trials on cabbages in the South-East climate zone (Hungary) CropScience Bayer CropScience Bayer CropScience, Report No.: M-492738-01-1, Edition Number: M-492738-01-1 Date: 2014-07-22 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /02 KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Plant safety to host crop; Yes Yes Y Bayer /03 Sweet cherry CropScience Bayer CropScience Bayer CropScience, Report No.: M-493240-01-1, Edition Number: M-493240-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /04 and efficacy trials on cherry fruit fly Rhagoletis cerasi in sweet cherry - CropScience Maritime climate zone Bayer CropScience Bayer CropScience, Report No.: M-493004-01-1, Edition Number: M-493004-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /02 ...also filed: KIIIA 6.1.3 /03

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /05 and efficacy trials on black cherry aphid Myzus cerasi in sweet and sour CropScience cherries - Maritime and South-East climate zones Bayer CropScience Bayer CropScience, Report No.: M-493231-01-1, Edition Number: M-493231-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /03 ...also filed: KIIIA 6.1.3 /04 KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /06 and efficacy trials on mealy plum aphid Hyalopterus pruni in plum - Maritime CropScience and South-East climate zones Bayer CropScience Bayer CropScience, Report No.: M-493233-01-1, Edition Number: M-493233-01-1 Date: 2014-07-31 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /04 ...also filed: KIIIA 6.1.3 /05 KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Efficacy trials on scales in Yes Yes Y Bayer /07 stone fruits - South-East climate zone CropScience Bayer CropScience Bayer CropScience, Report No.: M-493237-01-1, Edition Number: M-493237-01-1 Date: 2014-08-05 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /06

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 . Plant safety, yield and Yes Yes Y Bayer /08 quality to host crop; strawberry CropScience Bayer CropScience Bayer CropScience, Report No.: M-491755-01-1, Edition Number: M-491755-01-1 Date: 2014-07-11 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.1 /02 ...also filed: KIIIA 6.1.4.3 /02 KIIIA 6.2.1 2014 Compilation of trial reports for spirotetramat - Minimum effective dose and Yes Yes Y Bayer /09 efficacy trials on strawberries CropScience Bayer CropScience Bayer CropScience, Report No.: M-491753-02-1, Edition Number: M-491753-02-1 Date: 2014-07-14 ...Amended: 2014-07-25 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.2 /01 ...also filed: KIIIA 6.1.3 /11 KIIIA 6.2.1 2014 Compilation of trial report for SPT SC100 and SPT OD150 - spirotetramat Yes Yes Y Bayer /10 SC100 (100 g/L); spirotetramat OD150 (150 g/L) - Efficacy trials against CropScience 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 /05 ...also filed: KIIIA 6.1.3 /14 ...also filed: KIIIA 6.2.5 /01

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.2.1 2014 Compilation of trial report for SPT SC 100 / SPT OD 150 - Spirotetramat SC Yes Yes Y Bayer /11 100 (100 g/L) - Spirotetramat OD 150 (150 g/L) - Selectivity trials - 4 trials CropScience (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 /03 ...also filed: KIIIA 6.1.4.3 /03 KIIIA 6.2.1 2014 Compilation of trial report for spirotetramat SC100 - Minimum effective dose Yes Yes Y Bayer /12 and efficacy trials on onion thrips Thrips tabaci - Maritime climate zone CropScience (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 /06 ...also filed: KIIIA 6.1.3 /07 KIIIA 6.2.1 2014 Compilation of trial report for SPT SC 100 - Spirotetramat SC 100 (100 g/L) - Yes Yes Y Bayer /13 Efficacy trials - 7 trials (2012-2014) - Dasineura tetensis, Cecidophyopsis ribis, CropScience 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 ...also filed: KIIIA 6.1.2 /08 ...also filed: KIIIA 6.1.3 /12

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.2.1 2014 Compilation of trial report for SPT SC100 - Spirotetramat SC 100 (100 g/L) - Yes Yes Y Bayer /14 Efficacy trials in Poland against gall mite, aphids and midges in black currant CropScience Bayer CropScience Bayer CropScience, Report No.: M-491858-01-1, Edition Number: M-491858-01-1 Date: 2014-07-17 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /13 KIIIA 6.2.1 2014 Compilation of trial report for SPT SC100 - Spirotetramat SC100 (100 g/L) - Yes Yes Y Bayer /15 Taint studies in spinach CropScience Bayer CropScience Bayer CropScience, Report No.: M-479816-01-1, Edition Number: M-479816-01-1 Date: 2014-03-07 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.2 /04 KIIIA 6.2.5 2014 Compilation of trial report for SPT SC100 and SPT OD150 - spirotetramat Yes Yes Y Bayer /01 SC100 (100 g/L); spirotetramat OD150 (150 g/L) - Efficacy trials against CropScience 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 /05 ...also filed: KIIIA 6.1.3 /14 ...also filed: KIIIA 6.2.1 /10

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Annex Year Title Data Data Studies Owner point / Source (where different from company) protection protection relied on reference Company name, Report No., Date, GLP/GEP status (where relevant), claimed granted Y/N number published or not Y/N Y/N KIIIA 6.2.6 2008 Non-target terrestrial plants: an evaluation of the effects of Spirotetramat SC No No Y Bayer /01 100 g/L in the seedling emergence and growth test (Tier 1) CropScience Bayer CropScience, Report No.: SE07/053, Edition Number: M-298477-01-1 Date: 2008-03-06 GLP/GEP: no, unpublished ...also filed: KIIIA 10.8.1.3 /01 KIIIA 6.2.7 2007 Non-target terrestrial plants: an evaluation of the effects of Spirotetramat SC No No Y Bayer /01 100 g/L in the vegetative vigour test (Tier 1) CropScience Bayer CropScience, Report No.: VV07/054, Edition Number: M-295715-01-1 Date: 2007-12-19 GLP/GEP: no, unpublished ...also filed: KIIIA 10.8.1.2 /01 KIIIA 6.2.7 2008 Spirotetramat SC 100 g/L effect on the vegetative vigour of the non-target Yes Yes Y Bayer /02 terrestrial plant corn CropScience Bayer CropScience, Report No.: VV07/054, Edition Number: M-299193-01-1 Date: 2008-03-18 GLP/GEP: yes, unpublished ...also filed: KIIIA 10.8.1.2 /02 KIIIA 6.2.8 2012 Resistance statement - Information on the occurrence or possible occurrence No No Y Bayer /01 of the development of resistance for Movento containing the active substance CropScience spirotetramat (Addendum covering Aleyrodes proletella) Bayer CropScience, Report No.: M-430807-01-1, Edition Number: M-430807-01-1 Date: 2012-05-13 GLP/GEP: n.a., unpublished

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