HET COLLEGE VOOR DE TOELATING VAN ......13404 N Movento, 20152034 NLWTG HET COLLEGE VOOR DE...

13404 N

Movento, 20152034 NLWTG

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT

Op 22 december 2015 is van

Bayer CropScience S.A.-N.V.

Postbus 231

3640 AE MIJDRECHT

een aanvraag tot wijziging van toelating gewasbeschermingsmiddel (NL is CMS) ontvangen als bedoeld

in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het

gewasbeschermingsmiddel

MOVENTO

op basis van de werkzame stof spirotetramat. Nederland is in deze een betrokken lidstaat, als bedoeld in

artikel 36, tweede lid; de beoordelend lidstaat is Oostenrijk.

HET COLLEGE BESLUIT tot uitbreiding 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.

13404 N


� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

� De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de

voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2 van

deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

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, 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 en Evaluation Manual Zonaal

2.0

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 vastgesteld. 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.

13404 N


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, 7 december 2018

Het College voor de toelating van

gewasbeschermingsmiddelen en biociden,

voor deze:

de voorzitter,

Ir. J.F. de Leeuw

13404 N


BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20152034 NLWTG

Type aanvraag: Aanvraag tot wijziging van toelating

gewasbeschermingsmiddel (NL is CMS)

Middelnaam: MOVENTO

Verzenddatum aanvraag: 14 december 2015

Formele registratiedatum: * 20 januari 2016

Datum in behandeling name: 12 maart 2018

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

2.2 Stofinformatie

Werkzame stof Gehalte

spirotetramat 150 g/L

• De stof spirotetramat is per 1 mei 2014 goedgekeurd volgens Verordening (EU)1107/2009

(Uitvoeringsverordening (EU) No 1177/2013 d.d. 20 november 2013). De goedkeuring van deze

werkzame stof expireert op 30 april 2024.

2.3 Toelatingsinformatie

Toelatingsnummer: 13404 N

Expiratiedatum: 30 april 2025

Afgeleide parallel of origineel: Wijziging Middel

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewas

Gebruikers: Professioneel

W-coderingen en aflever- en opgebruiktermijnen:

� W-codering professioneel gebruik: W6

� Vorige w-codering professioneel gebruik: W5

� Aflevertermijn professioneel gebruik: n.v.t.

� Opgebruiktermijn professioneel gebruik: n.v.t.

2.4 Verpakkingsinformatie

Aard van het preparaat:

Olie dispersie

13404 N


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel MOVENTO

Professioneel gebruik

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:

spirotetramat

Pictogram GHS07

GHS08

GHS09

Signaalwoord Waarschuwing

Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken.

H319 Veroorzaakt ernstige oogirritatie.

H361fd Wordt ervan verdacht de vruchtbaarheid te schaden. Wordt

ervan verdacht het ongeboren kind te schaden.

H411 Giftig voor in het water levende organismen, met langdurige

gevolgen.

Voorzorgsmaatregelen P280 Beschermende handschoenen/beschermende

kleding/oogbescherming/gelaatsbescherming dragen.

P308 + P311 Na (mogelijke) blootstelling: een

ANTIGIFCENTRUM/arts/... raadplegen.

P501 Inhoud/verpakking afvoeren naar ....

SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water

verontreinigt.

Aanvullende

etiketelementen

EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke

gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Nee

Voelbare gevaarsaanduiding verplicht Nee

Part A

National Assessment - Netherlands

MOVENTO Registration Report – Central Zone

of 56

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

Date: November 2018

REGISTRATION REPORT

Part A

Risk Management

Product code:

Product name:

102000016434

MOVENTO (Spirotetramat

OD 150)

Active Substance: Spirotetramat (150 g/L)

Country: The Netherlands

Central Zone

Zonal Rapporteur Member State: Austria

NATIONAL ASSESSMENT

Applicant: Bayer CropScience SA-NV

Date: November 2018

Part A



of 56


Date: November 2018

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.

Part A



of 56


Date: November 2018

Table of Contents

PART A – Risk Management ..................................................................................................... 10

1 Details of the application ..................................................................................... 10

1.1 Application background ...................................................................................... 10

1.2 Annex I inclusion ................................................................................................. 10

1.3 Regulatory approach ........................................................................................... 11

1.4 Data protection claims ......................................................................................... 11

1.5 Letters of Access .................................................................................................. 11

2 Details of the authorisation ................................................................................. 12

2.1 Product identity ................................................................................................... 12

2.2 Classification and labelling ................................................................................. 12

2.3 Authorised product uses ..................................................................................... 13

3 Risk management ................................................................................................ 17

3.1 Reasoned statement of the overall conclusions taken in accordance with the

Uniform Principles .............................................................................................. 17

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) ............ 17

3.1.2 Methods of analysis (Part B, Section 2, Point 5) ............................................... 17

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) ............ 17

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) ............. 17

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) ........................................ 18

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) ..................................................... 18

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) ............................................. 18

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) ........................................... 18

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) ............................................... 18

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) ...................... 19

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) ................................................ 19

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) .......................................... 19

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) ...................... 19

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5,

Points 9.4 and 9.5) ................................................................................................ 20

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,

Section 5, Point 9.6) ............................................................................................. 20

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B,

Section 5, Points 9.7 and 9.8) .............................................................................. 21

Part A



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Date: November 2018

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

Point 9.9) ............................................................................................................... 21

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) ....................................................... 22

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) . 22

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) ............................... 23

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

and 10.5) ............................................................................................................... 23

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

Point 10.6) ............................................................................................................. 23

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) ............ 23

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) . 23

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora

and Fauna) (Part B, Section 6, Point 10.8) ........................................................ 24

3.1.7 Efficacy (Part B, Section 7, Point 8) ................................................................... 24

Regarding the presented trials carried out with SPT SC 100, the target dose of 75 g a.s/ha

can be agreed due to the high numerical benefit compared to 45 g a.s/ha. .... 24

Cavariella aegopodii (CAVAAE) on carrot .............................................................................. 24

3.2 Conclusions ........................................................................................................... 27

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 .............. 27

None 27

Appendix 1 Copy of the product label .................................................................................... 28

Appendix 2 – Letter of Access .................................................................................................... 47

Appendix 3 – List of data submitted in support of the evaluation ......................................... 48

Part A



of 56


Date: November 2018

PART A – Risk Management

This document describes the acceptable use conditions required for the authorization of MOVENTO

containing spirotetramat in The Netherlands. This evaluation is required subsequent to the application for

a label extension in carrots and when appropriate, in additional minor crops1.

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.

ZRMS Austria did not provide a core assessment, except for the aspects residues and efficacy. It was

considered that a risk assessment was not required for this extension of use, as it will be covered by the

risk envelope from the existing uses/evaluations.

The information, data and assessments provided in Registration Report, Parts B includes assessment of

further data or information as required at national registration by the EU review. It also includes

assessment of data and information relating to MOVENTO where that data has not been considered in the

EU review. Otherwise assessments for the safe use of MOVENTO have been made using endpoints

agreed in the EU review of spirotetramat.

This document describes the specific conditions of use and labelling required for The Netherlands for the

label extension of MOVENTO.

Appendix 1 of this document provides a copy of the 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 December 2015.

The application is an extension of the existing authorization of MOVENTO for use on carrots, radishes,

Jerusalem artichoke, red beet, celeriac, black salsify, horseradish and chicory.

1.2 Annex I inclusion

Spirotetramat was EU approved in accordance with Regulation (EC) No 1107/2009 under Implementing

Reglation (EU) No 1177/2013 which shall apply from 1 May 2014.

The Regulation (EU) No 1177/2013 provides specific provisions under Part B which need to be

considered by the applicant in the preparation of their submission and by the MS prior to granting an

authorisation.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No

1107/2009 , the conclusions of the review report on spirotetramat, and in particular Appendices I and II

thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013

shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to insectivorous birds.

This concern was addressed in the submission.

1 - 0213000 : other root and tuber vegetables except sugar beets (namely beetroot, celeriac, horse radishes, Jerusalem artichokes, parsnips,

parsley roots, radishes, salsifies, swedes/rutabagas, turnips

- 0900030 : chicory roots

Part A



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Date: November 2018

1.3 Regulatory approach

To obtain authorization of the product MOVENTO, the active substance must meet the conditions of

Directive 91/414/EEC Annex I inclusion and be supported by dossiers satisfying the requirements of

Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points.

The EFSA Scientific Report for spirotetramat (EFSA Journal 2013;11(6):3243) is considered to provide

the relevant scientific information for the review of the product.

This application was submitted in order to allow the authorization of this product in The Netherlands in

accordance with the above.

MOVENTO (Specification No.102000016434) was not the representative formulation for the the

inclusion of spirotetramat into the Annex to Implementing Regulation (EU) No. 540/2011 (the

representative formulation was also an OD 150 but with a slightly different composition Specification

No.102000011380). Since the formulation has not been previously evaluated according to Uniform

Principles at European level, detailed summaries of the studies have been provided. Accordingly, copies

of the reports of all studies required for the evaluation have been provided in this submission.

1.4 Data protection claims

The reference list included in the dossier defines the list of studies and reports, submitted with the

application, for which a claim for data protection was made. This claim for protection was made as the

studies and reports were submitted and used as the basis for approval for the first time in The

Netherlands. Based on Article 59 of Regulation (EC) 1107/2009 Bayer S.A.S. (Bayer CropScience) claim

10 years protection for these studies and reports. The authority confirms that these studies and reports are

protected for 10 years from the data of authorisation of the product and thus cannot be used for the benefit

of another applicant.

1.5 Letters of Access

The applicant has access to any protected studies required for the evaluation of the product or has

provided sufficient data to show that access is not required.

Part A



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Date: November 2018

2 Details of the authorisation

2.1 Product identity

Product Name MOVENTO

Spirotetramat OD 150 (150 g/L)

Specification n°102000016434-02/03

Authorization Number

(for re-registration)

13404 N

Function Insecticide, acaricide

Applicant Bayer CropScience SA-NV

Composition 150 g/L spirotetramat

Formulation type Oil Dispersion [Code: OD]

Packaging Size : up to 10 L

Material : HDPE or coex-HDPE/PA

2.2 Classification and labelling

The current classification and labelling can be maintained.

Please refer to the assessment for re-registration of the plant protection product Movento as confirmed by

Board decision d.d. October 31, 2018 published in the authorised products database of Ctgb.

Part A



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Date: November 2018

2.3 Authorised product uses

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

Use-No.

Member state(s)

Crop and/ or situation

F G or I

Pests or Group of pests controlled

Application Application rate per treatment PHI (days)

Remarks:

a) max. no. of applications per crop and season

b) Maximum product rate per season

c) additional remarks

Method / Kind

Timing / Growth stage of crop & season

Number / (min. Interval between applications)

L product / ha

kg as/ha Water L/ha min / max

1 Netherla

nds

Carrot

DAUCS

F Pemphigus phenax

PEMPDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0.5

b) 2

a) 0.075

b) 0.3

200-600 21

2 Netherla

nds

Carrot

DAUCS

F Cavariella aegopodii

CAVAAE

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0.3

b) 0.6

a) 0.045

b) 0.09

200-600 21

Minor uses according to article 51

3 Netherla

nds

Potatoes SOLTU F Tetranychus

urticae TETRUR

Foliar

spraying

BBCH69 - End

of flowering

BBCH95

2

(7 d)

a) 0.5

b) 1.0

a) 0.075

b) 0.15

150 - 400 14 After flowering – No flowers present

4 Netherla

nds

Radishes RAPSR,

RAPSN

F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21 Maximum of 3 growing cycles per year

are possible: 2 applications per 12

months is evaluated and not per

growing cycle.

5 Netherla

nds

Radishes RAPSR,

RAPSN

F Aphis spp.. APHISP

Cavariella aegopodii

CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21 Maximum of 3 growing cycles per year

are possible: 2 applications per 12

months is evaluated and not per

growing cycle.

6 Netherla

nds

Skirret SIUSI F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

7 Netherla Skirret SIUSI F Aphis spp.. APHISP Foliar BBCH12-49 2 a) 0,3 a) 0,045 200-600 21

Part A



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Date: November 2018

nds Cavariella aegopodii

CAVAAE

Semiaphis dauci

SEMIDA

spraying APR-OCT (14 d) b) 0.6 b) 0,09

8 Netherla

nds

Turnip-rooted parsley

PARCT

F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

9 Netherla

nds

Turnip-rooted parsley

PARCT



CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

10 Netherla

nds

Parsnips PAVSA F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2 (14 d) a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

11 Netherla

nds

Parsnips PAVSA F Aphis spp.. APHISP


CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

12 Netherla

nds

Jerusalem artichoke

HELTU

F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

13 Netherla

nds

Jerusalem artichoke

HELTU



CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

14 Netherla

nds

Red beet BEAVD F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

Part A



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Date: November 2018

15 Netherla

nds

Red beet BEAVD F Aphis spp.. APHISP


CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

16 Netherla

nds

Celeriac APUGR F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

17 Netherla

nds

Celeriac APUGR F Aphis spp.. APHISP


CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

18 Netherla

nds

Black salsify SCVHI

TROPS,

F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

19 Netherla

nds

Black salsify SCVHI

TROPS,



CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

20 Netherla

nds

Horseradish ARWLA F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

21 Netherla

nds

Horseradish ARWLA F Aphis spp.. APHISP


CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

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22 Netherla

nds

Chicory CICIS F Pemphigus phenax

PEMPDA, Trioza

apicalis

TRIZAP

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,5

b) 2

a) 0,075

b) 0,3

200-600 21

23 Netherla

nds

Chicory CICIS F Aphis spp.. APHISP


CAVAAE

Semiaphis dauci

SEMIDA

Foliar

spraying

BBCH12-49

APR-OCT

2

(14 d)

a) 0,3

b) 0.6

a) 0,045

b) 0,09

200-600 21

Part A


MOVENTO


Date: November 2018

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: The application is an extension for use on carrots, radishes, Jerusalem artichoke, red

beet, celeriac, black salsify, horseradish and chicory. The physical, chemical and technical properties are

not expected to change. All the data were already evaluated in the zonal application of MOVENTO

(20071148 TGV). However the applicant has provided additional information on the surface tension at an

in-use concentration of 1 g/L (0.1% w/v), pack stability after accelerated storage stability for 14 days at

54°C in HDPE and coex-HDPE/PA and suspensibility at 0.01% in CIPAC water D. All results were

found acceptable.

Implications for labelling: None

Compliance with FAO guidelines: The product MOVENTO complies with FAO specifications, as far as

could be assessed.

Compatibility of mixtures: Tank mixtures with other pesticides are not recommended on the product

label for MOVENTO.

Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity,

size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling,

resistance & compatibility with the contents of the packaging, have been submitted for MOVENTO,

evaluated and is considered to be acceptable.

Nature and characteristics of the protective clothing and equipment: Information regarding the

required protective clothing and equipment for the safe handling of MOVENTO has been provided and is

considered to be acceptable.

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

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)

The application is an extension for use on carrots, radishes, Jerusalem artichoke, red beet, celeriac, black

salsify, horseradish and chicory. The analytical methods for the active substance, relevant impurities and

CIPAC methods are not expected to change. All the data were already evaluated in the zonal application

of MOVENTO (20071148 TGV).

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)

The application is an extension for use on carrots, radishes, Jerusalem artichoke, red beet, celeriac, black

salsify, horseradish and chicory. The analytical methods for determination of residues are not expected to

change. All the data were already evaluated in the zonal application of MOVENTO (20071148 TGV).

The extension for use is on matrices which are covered by the original authorization and therefore no

additional data is required.

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

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1)

Acute toxicity studies for MOVENTO (Specification No. 102000016434) were not evaluated as part of

the EU review of the spirotetramat. Therefore, all relevant data were provided and are considered

adequate.

It is referred to the original authorisation of this product.

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3)

Operator exposure to MOVENTO (Specification No. 102000016434) was not evaluated as part of the EU

review of spirotetramat. Therefore all relevant data and risk assessments have been provided and are

considered to be adequate.

It is referred to the core dossier for the re-registration of the product MOVENTO, which covers operator

exposure relevant to this application for extension of use. In the core dossier, mechanical and manual

downward spray application were assessed. A safe use was concluded for the unprotected operator

regarding mechanical downward spraying. When considering manual downward spraying for the minor

uses applied for, the assessment indicated that PPE are required to obtain a safe use (coverall and gloves

during mixing/loading and application).

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4)

Bystander exposure to MOVENTO was not evaluated as part of the EU review of spirotetramat.

Therefore, all relevant data and risk assessments have been provided and are considered adequate.

It is referred to the core dossier for the re-registration of this product. In that core assessment, bystander

and resident exposure were assessed for downward spraying in the field considering 0.075 kg a.s./ha

using the German model. In the core assessment only two applications were taken into account, whereas

for this application for extension up to four uses are applied for. Regarding the resident exposure

assessment, the number of applications influences the total exposure. Considering the very low exposure

estimated in the core dossier (1.2% of the AOEL) and the only difference being two additional treatments,

an unacceptable risk for the resident is not anticipated. The bystander exposure is covered by the

assessment in the core (as this only considers a single exposure), where a safe use has been shown (0.5 %

of the AOEL). For the re-registration of this product, a national addendum for the Netherlands was

prepared, in which bystander and resident exposure were additionally assessed using the UK method. In

that national addendum upward spraying was assessed as a worst case. The dose assessed for the re-

registration was higher than the dose applied for now in this extension application (0.15 kg a.s./ha vs.

0.075 kg a.s./ha). The assessment with the UK method in the national addendum for the re-registration is

considered worst case (results in max. 2.5% of the AOEL) and covers the uses applied for in this

application for extension.

Overall, no unacceptable risks are anticipated for bystanders or residents.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5)

Worker exposure to MOVENTO was not evaluated as part of the EU review of spirotetramat. Therefore,

all relevant data and risk assessments have been provided and are considered adequate.

It is referred to the core dossier for the re-registration of this product. This extension of use involves use

in vegetables and in the core dossier of the re-registration worker exposure in vegetables was assessed

using a slightly lower application rate (0.072 kg a.s./ha vs. 0.075 kg a.s./ha) with four applications.

Considering the relatively low exposure calculated (32% of the AOEL) it is not expected that the small

difference in application rate will influence the final outcome. No unacceptable risks are anticipated for

the unprotected worker.

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

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7)

The existing EU MRL for plants and products of animal origin are published in Regulation (EC) No.

2017/1016 of 14 June 2017 amending Regulation (EC) 396/2005. In the EFSA peer review (EFSA

Journal 2013;11(5):3220), the residue definition for risk assessment was set as ‘Spinetoram (sum of XDE-

175-J, XDE-175-L), metabolites N-demethyl-175-J and N-formyl-175-J, expressed as spinetoram’. For

monitoring, a residue definition as ‘Spinetoram (sum of XDE-175-J, XDE-175-L) only’ was proposed.

However, since this residue definition is still not into force the previous residue definition for monitoring

“Spirotetramat and its 4 metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-monohydroxy,

and BYI08330 enol-glucoside, expressed as spirotetramat” is applied to calculate the MRLs in the crops

under consideration within the framework of this registration. The MRLs for ‘0213000 – other root and

tuber vegetables except sugar plants’ and ‘0900030 – chicoree roots’ is 0.1 mg/kg.

Stability of residues were assessed during the EU approval process and considered sufficient. No new

trials are submitted within this application. The same accounts for studies on the metabolism in plants or

livestock.

New residue trials on carrots were submitted within this application. An extrapolation from carrots to

chicory roots is possible according to SANCO 7525/VI/95 rev. 9. Calculated MRLs based on these

residue trials confirm that current EU-MRLs are not exceeded.

Livestock feeding studies were evaluated in the DAR. Even though the dietary burden is exceeding the

trigger value, no new studies are required for this application as the requested crops do not have a major

impact on the dietary burden of animals.

Processing studies were evaluated in the DAR and considered sufficient. No new studies are required.

The same accounts for studies in rotational crops.

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)

The toxicological profile of spirotetramat was evaluated at EU level, which resulted in the proposal of an

ADI (0.05 mg/kg bw/d) and an ARfD (1 mg/kg bw) that were considered in the frame of this evaluation.

Chronic consumer exposure was calculated taking into account every possible crop in the EU on which

spirotetramat may be used. For the acute exposure calculation only the requested crops were considered.

Based on EFSA PRIMo (rev2), chronic and acute exposures were considered as acceptable for all groups

of consumers.

Based on the dietary risk assessment performed for spirotetramat, it can be concluded that the intended

uses of Spirotetramat OD 150 G do not lead to an unacceptable risk for consumers when applied

according to the recommendations.

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

Appropriate endpoints were used to calculate PECs for Spirotetramat OD 150 G, spirotetramat and its

metabolites in soil, surface water, groundwater and air for the intended use patterns.

ZRMS Austria did not provide a core assessment for the aspect fate and behaviour, because it was

considered that a risk assessment was not required for this extension of use, as it will be covered by the

risk envelope from the existing uses/evaluations. This national addendum only addresses the national

specific requirements of the Netherlands (higher tier groundwater and surface water assessment).

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The use patterns evaluated for the Netherlands are presented below.

Application pattern evaluated for the Netherlands

Member

state

Crop Timing of

application

Number of

applications

Appl.

interval

min.

Max. single

label rate

Max application rate,

individual treatment

[g a.s./ha]

BBCH max. [days] [L/ha] Spirotetramat

AUT, DEU,

GBR, IRL,

NLD

Carrots 12 – 49 4 14 0.5 75

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

9.4 and 9.5)

ZRMS Austria considered that a risk assessment is not relevant for this extension of use, as it will be

covered by the risk envelope from the existing uses/evaluations. No National Addendum considering

national specific requirements is required.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,

Section 5, Point 9.6)


considered that a risk assessment is not relevant for this extension of use, as it will be covered by the risk

envelope from the existing uses/evaluations. Therefore there is no first tier groundwater leaching

assessment (containing the Kremsmünster scenario in FOCUS-PEARL 4.4.4 as relevant for The

Netherlands) available. However, a higher tier assessment was triggered based on the substance properties

of some of the metabolites (DT50 < 10 days and Kom < 10 L/kg).

Predicted environmental concentrations of spirotetramat and its metabolites in groundwater recharge

(PECgw) were calculated using the GeoPEARL model (version 3.3.3). The GeoPEARL model is a

spatially distributed pesticide leaching model that calculates leaching of pesticides and metabolites to the

uppermost groundwater for a number of plots, i.e. a combination of soil and weather conditions,

representing the area of use (Tiktak et al., 2003)2. For practical reasons a number of 252 plots were

selected.

Crop interception rates follow the EFSA and FOCUS recommendations (EFSA 20143; FOCUS 20144).

For all proposed uses of spirotetramat the PECgw values were less than 0.001 µg/L. This is below the EU

trigger of 0.1 µg/L and also 0.01 µg/L trigger established in the Netherlands for use of products in

groundwater protection areas.

There are no concerns for groundwater from the use of spirotetramat in accordance with the use pattern

for the current formulation and no restriction is needed.

Monitoring data groundwater

There are no data available regarding the presence of the active substance spirotetramat or its metabolites

in groundwater.

2 Tiktak A., van der Linden A.M.A. and Boesten J.J.T.I., 2003: The GeoPearl Model. Model description, applications and manual.

National Institute of Public Health and the Environment RIVM, Bilthoven, NL. RIVM report 716601007/2003 3 EFSA, 2014: EFSA Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of

active substances of plant protection products and transformation products of these active substances in soil. EFSA Journal

2014;12(5):3662 4 FOCUS, 2014: Generic Guidance for Tier 1 FOCUS Groundwater Assessments, Version 2.2

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3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section

5, Points 9.7 and 9.8)

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 actual maximum concentrations in surface water and sediment (PECsw and PECsed) and the maximum

time weighted averaged (TWAsw) concentrations in surface water (4, 21 and 28 days) of spirotetramat and

its metabolites were calculated for the Dutch spring and autumn scenario based on a drift value of 1 %

corresponding to the use of 50% drift reducing nozzles. Meanwhile the Activity Decree – a national

regulation controlling emissions to the environment – has been adapted resulting in an obligatory

minimum spray drift reduction of 75% (corresponding to 0.5% spray drift). This means that the provided

assessment is conservative with respect to the conditions laid down in the Activity Decree.

The results for PECsw and PECsed for the active substance and its metabolites were used for the eco-

toxicological risk assessment.

Monitoring data surface water

The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is used to

evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the

observed concentrations exceed threshold values.

The authorisation threshold equals 8.5 µg a.s./L (consisting of first or higher tier acute or chronic

ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in

this case 0.01*ECinvertebrate). There is no EQS or MPC available.

As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed uses

of the product.

Drinking water criterion

Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or

existing substances on the Dutch market (authorised for more than 3 years).

- For new substances, a pre-registration calculation is performed.

- For existing substances, the assessment is based on monitoring data of VEWIN (drinking water

board).

o If for an existing substance based on monitoring data no problems are expected by VEWIN,

Ctgb follows this VEWIN assessment.

o If for an existing substance based on monitoring data a potential problem is identified by

VEWIN, Ctgb assesses whether the 90th percentile of the monitoring data meet the drinking

water criterion at each individual drinking water abstraction point.

The active substance spirotetramat has been on the Dutch market for > 3 years (authorised since 21-01-

2011). This period is sufficiently large to consider the market share to be established. There are no

concrete indications for concern about the consequences of this product for surface water from which

drinking water is produced, when used in compliance with the directions for use. No exceeding of the

drinking water criterion is expected. The standards for surface water destined for the production of

drinking water are met.

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

9.9)

http://www.pesticidesatlas.nl/

http://www.bestrijdingsmiddelenatlas.nl/

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considered that a risk assessment is not relevant for this extension of use, as it will be covered by the risk

envelope from the existing uses/evaluations.

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

ZRMS Austria did not provide a core assessment for the aspect ecotoxicology. Therefore it is not possible

to refer to the core dossier. According to the Austrian responses in the commenting round, they

considered it not necessary to perform an ecotoxicological risk assessment, as the proposed uses were

covered by the recently assessed re-registration. Unfortunately, this has not been discussed or shown in

the core dossier.

Additionally, as current extension is an article 33, the risk assessment should be transparent and in the

light of current scientific and technical knowledge using guidance documents available at time of

application. Since the submission of the re-registration, the new Aquatic guidance (EFSA 2013 has gone

into force). Therefore the risk assessment to aquatic organisms needs to be performed.

As the correspondence with Austria suggest that the extended uses are covered by the reregistration, but

no documents are available to show this, a risk envelope approach, compared with the re-registration has

been done for transparency reasons.

The use pattern for the extension of MOVENTO in the Netherlands comprises the use in carrots and a

number of minor crops. The minor crops radish, Jerusalem artischoke, red beet, celeriac, black salsify,

horse radish, skirret, turnip-rooted parsley, parsnips are all in the group of root and stem vegetable, and

are comparable to carrots. Chicory belongs to Leafy vegetables. Note that for radish 3 crop cycles are

possible. However those multiple crop cycles have not been covered in the reregistration.

The risk of the applied use in carrot, Jerusalem artichoke, red beet, celeriac, black salsify, horse radish,

skirret, turnip-rooted parsley, parsnips is equal to the risk of the authorised uses with regard to the

environment for all aspects.

The following restriction sentences should be added to ensure acceptable risk to bees and non-target

arthropods:

Dangerous to bees. To protect bees and pollinating insects do not apply to crop plants when in flower. Do

not use where bees are actively foraging. Do not apply when flowering weeds are present.

Om niet tot de doelsoorten behorende insecten te beschermen is toepassing van dit middel uitsluitend

toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse

DRT95 in combinatie met een totale teeltvrije zone van 2 meter.

For radish, 3 crop cycles have not been covered in risk assessment. A single crop cycle is covered by

other uses.

Regarding chicory, the chronic risk to birds is not covered by the risk envelope of re-registration uses

when considering 4 applications. This was addressed. Two or three applications are covered.

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

Birds

The Tier I long-term risk assessment in re-registration Core resulted in no acceptable long-term risk for

generic focal species “medium herbivorous/granivorous bird “pigeon”. Therefore, a refined long-term risk

assessment for the application of Spirotetramat OD 150 in leafy vegetables is required.

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The refined risk assessment resulted in an acceptable risk for all focal species for intended uses in leafy

vegetables.

Terrestrial vertebrates (other than birds)

Risk to mammals covered by re-registration Core.

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

The risk assessment based on maximum PECsw values derived by country 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. No mitigation measures are needed.

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

10.5)

Bees

As the core dossier concluded that mitigation measures are required, this is considered an Member state

specific issue. See also NL addendum for the reregistration.

In line with re-registration NL addendum, to prevent flowering of weeds in the field, SP8 needs to be

prescribed:

“Dangerous to bees. To protect bees and pollinating insects do not apply to crop plants when in flower.

Do not use where bees are actively foraging. Do not apply when flowering weeds are present.”

For the off-field, the same mitigation measures as required for non-target arthropods (section 10.5),

should be used.

Other non-target arthropods

For 2 applications the same restriction sentences apply as for field crops with downward spraying in

reregistration.

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

10.6)

Earthworms

Acceptable risk to earthworms demonstrated in re-registration Core.

Effects on other soil non-target macro-organisms

Acceptable risk to soil macro-organisms demonstrated in re-registration Core.

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

A study on the organic matter breakdown is not required based on the DT90, f value of the active substance

and acceptable TER values for earthworms, soil macro-organisms and/or soil micro-organisms.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)

Acceptable risk to Soil Non-target Micro-organisms demonstrated in re-registration Core.

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3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and

Fauna) (Part B, Section 6, Point 10.8)

The risk assessment according to country specific requirements indicated that no unacceptable effects are

to be expected for non-target terrestrial plants. No mitigation measures are needed.

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)

This application concerns a label extension, the proposed uses are on foliar spraying on Carrot against

Pemphigus phenax and Cavariella aegopodii. Additionally the applicant applied for a number of minor

uses on radish, jerusalem artichoke, red beet, celeriac, black salsify, horseradish and chicory.

Efficacy data

Part of the efficacy results was provided with the formulation SPT SC 100 as bridging formulations of

SPT 150 OD. Efficacy results obtained with the formulation SPT SC 100 are appraised to be valid for the

determination of the minimum effective dose and the evaluation of the effectiveness for the formulation

SPT OD 150 against the claimed targets, even though in some trials (predominantly at assessments close

to the application) SPT 150 OD outperformed SPT 100 SC .

Regarding crop safety, only trials conducted with SPT 150 OD are appraised to be supportive.

Minimum effective dose

Pemphigus phenax (PEMPDA) on carrot

Eight trials of Maritime zone was provided. In all trials SPT SC100 was assessed at the target dose 75 g

a.s./ha, and at one lower dose of 45 g a.s/ha. In several trials SPT OD150 at 75 g a.s./ha was assessed, too.

Regarding pest incidence assessments after two foliar sprays, the difference between the two dose rates of

45 and 75 g a.s./ha was statistically significant in one of 6 trials only. A numerical benefit of the higher

dose was seen in 5 of 6 trials.

Neither a statistically significant difference was seen for pest severity between the two dose rates in

question, nor was the numerically benefit (max. 11 %) as big as seen in pest incidence results.

At assessments carried out after the first spray (2 trials), no significant difference was seen between the

two dose rates of 45 and 75 g a.s./ha of SPT 100 SC. SPT 150 OD was assessed in these trials too, but

only at 75 g a.s./ha. In these trials SPT 150 OD clearly outperformed SPT 100 SC (+ 17–20 % efficacy).

No dose response was seen regarding the yield of roots.

Regarding the presented trials carried out with SPT SC 100, the target dose of 75 g a.s/ha can be

agreed due to the high numerical benefit compared to 45 g a.s/ha.

Cavariella aegopodii (CAVAAE) on carrot

To justify the target dose of 45 g a.s./ha to control CAVAAE on carrots, the applicant presented 6 trials

(all Maritime zone, BE, F, UK). In all trials SPT SC 100 was assessed, and in 2 additionally trials SPT

OD 150. No doses lower than the target dose were assessed, but a higher dose of 75 g a.s./ha. Regarding

the presented 2 trials carried out with SPT OD 150, the target dose of 45 g a.s./ha can be agreed due to the

negligible benefit compared to 75 g a.s./ha. NL agrees that 45 g a.s./ha to be the minimum effective dose

on the control CAVAAE on carrots.

Trioza apicalis (TRIZAP) on carrot

Seven trials (1 Maritime zone; Sweden, 6 North-east zone, Poland) was provided.

From one single EPPO Maritime zone trial minimum effective dose cannot be derived. Efficacy was very

low in this trial, and no statistically significant difference was seen for the two assessed dose rates

irrespective the kind of assessment.

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The applicant considers the further 6 North-east zone trials also to be valid to support this use in carrots

for the countries of the maritime EPPO zone. No further information on comparability of climate, pest

biology resp. agricultural practice was provided. ZRMs left the decision open to cMS, whether they

accept the applicant’s approach, or not. Carrots are a major use in the Netherlands. North-east zone trials

does not facilitate authorization in Maritime zone. The claimed minimum effective dose is not accepted

due to lack of data.

No minimum effective dose tests were carried out with other aphid species such as Semiaphis dauci or

Aphis spp.

Due to EPPO Extrapolation Tables for Minor Uses data from lettuce (and cucumber) can support efficacy

in umbelliferous crops such as carrot. In the Netherlands however the authorised rate in lettuce is 75 g

a.s./ha. No authorisations at the low rate exist for any crop. Minimum effective dose is not supported at

the claimed rate.

Efficacy tests

Pemphigus phenax (PEMPDA) on carrot

Eight trials from the Maritime zone was presented.

Two successive foliar sprays with SPT OD 150 at the recommended dose rate of 0.5 L/ha (75 g a.s./ha)

showed a high level of control of PEMPDA, with a certain consistency of the performance (>90%

Abbott) between trials whatever the positioning (early or late). A slight trend is that the late positioning

on established colonies on roots shows lower performance (still above 90% efficacy) compared to early

timing during the adult migration. After a single late application (2 trials) insufficient efficacy was seen

(< 80 %, incidence).

The test product in any case outperformed the chosen reference product, which was not able to

sufficiently control root aphids, due to its mode of action, and was not authorized to control PEMPDA.

It can be concluded that SPT OD 150 at the recommended dose rate of 0.5 L/ha (75 g a.s./ha) on the

control of PEMPDA is authorized.

Cavariella aegopodii (CAVAAE) on carrot

Five trials of the Maritime zone are presented.

One foliar spray with SPT OD 150 at the recommended dose rate of 0.3 L/ha (45 g a.s/ha) showed in

most trials a sufficient level of control of CAVAAE apterae (94.3 % SPT OD150 resp. 90.1 % SPT

SC100). In the trial with the highest infestation, 14 days after a single application insufficient efficacy

was seen, whereas one week after the second application a high level of control was achieved.

The test product in 2 of 3 trials clearly outperformed the reference product based upon pirimicarb+

lambda-cyhalothrin (statistically significant in 1 trial where the reference completely failed), and showed

either weaker or better control if compared to thiacloprid (with a comparable weak initial effect).

Therefore the applicant recommends two successive applications with SPT OD 150 at 0.3 L/ha for the

control of CAVAAE.

Due to EPPO Extrapolation Tables for Minor Crops extrapolation from CAVAAE to all leaf aphids on

carrots is not possible. ZRMS pointed out that data from lettuce can support umbelliferous crops and

leave the conclusions open for CMS. However In the Netherlands however the authorised rate in lettuce is

75 ga.s/ha. No authorisations at the low rate exist for any crop.

Cavariella aegopodii (CAVAAE) on carrot at claimed dose rate can be authorized.

Trioza apicalis (TRIZAP) on carrot

Only one trials out of Maritime zone (Sweden) was presented. Additionally 6 trials from North-east

zone (Poland) is presented.

In the single Maritime zone trial pest pressure was very low, however, also very low levels of efficacy

were recorded both for the reference product based upon lambda-cyhalothrin (applied under dosed) and

SPT SC100, even though products were applied 5 times. Overall, with one single EPPO Maritime zone

trial efficacy cannot sufficiently be demonstrated (not even for a minor use).

The applicant considers the further 6 North-east zone trials also to be valid to support this use in carrots

for the countries of the maritime EPPO zone. No further information on comparability of climate, pest

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biology resp. agricultural practice was provided. ZRMS leaves the decision open to cMS if they accept

the applicant’s approach, or not.

Carrots are a major use in the Netherlands. North-east zone trials does not facilitate authorization in

Maritime zone.

It is therefore concluded that the claimed use on TRIZAP cannot be authorised.

Effects on yield and quality

Impact on the quality of plant and plant product

The applicant did not provide any data on the possible impact of SPT OD150 on the quality of carrots or

other umbelliferous root crops.

SPT OD150 is already authorized in several crops, including several vegetable crops, but not in any

umbelliferous crop. Spirotetramat is a systemic compound, therefore a negative impact on the quality of

harvested carrots cannot be excluded a priori. However, zRMS concluded that due to the relatively long

PHI of 21 days as applied for authorization, and the proved neutral behaviour in other crops, a negative

impact on the quality of yield seems unlikely. NL agrees with conclusions of zRMS.

Effects on the processing procedure

Six studies were conducted with canned or quick frozen carrots. However, only 2 of them are regarded to

be relevant for SPT 150 OD (all other studies were carried out with the SPT SC100 formulation). In the

remaining studies only quick frozen carrots were assessed, and no statistically significant difference was

recorded between the treated and the untreated samples. No taint was detected. Microbial fermentation

was not assessed (appraised to be not relevant for carrots). Overall, no negative impact on quick frozen

carrots has to be expected.

Effects on the yield of treated plants and plant products

Three Maritime zone trials free of pest or with very low infestation were presented. In all these trials no

negative effect on the yield was seen. Furthermore, yield was assessed in several efficacy trials. In all

these trials no negative effect on the yield was seen.

Adverse effects

Phytotoxicity on host crop

Four pest-free efficacy trials, 1 plant safety trial, and 2 field trials were presented to generate specimen for

taint tests. Phytotoxicity was also assessed in all efficacy trials. Only trials conducted with SPT 150 OD

are regarded to be supportive to demonstrate crop safety of SPT OD150.No phytotoxic symptom has been

observed with SPT OD 150 on at least 7 carrot cultivars. Overall, SPT OD150 is regarded to be crop safe.

Impact on succeeding crops

An assessment of succeeding crops according to EPPO Standard PP1/207 was not carried out. However,

this assessment may be waived since spirotetramat is not known to cause any phytotoxic effects.

Impact on other plants including adjacent crops

The use of the product according to the intended use patterns (for both re-registration and label extension

GAPs) is not expected to produce unacceptable effects on terrestrial non-target plants growing near

treated fields.

Possible development of resistance or cross-resistance

No resistance risk assessment according to EPPO was provided, the applicant referred to a resistance

statement of 2012 already submitted within the framework of the initial assessment.

Spirotetramat is a member of the ketoenol class of insecticides and is classified by IRAC in mode of

action class 23.

Considering both the inherent resistance risk of spirotetramat and of the pests, in particular of aphids,

resistance development is likely.

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In carrots, currently a maximum of 4 applications per crop and year are applied (4 applications against

Pemphigus phenax, Trioza apicalis; 2 applications against Aphis sp., Cavariella aegopodii, Semiaphis

dauci).

zRMS recommended reconsidering a further limitation of these uses on national level, Even though

currently no resistance was found in MYZUPE.

In the Dutch label the following warning sentences is required. This is already present in the existing

label.

Resistentiemanagement

Dit middel bevat de werkzame stof spirotetramat. Spirotetramat behoort tot de acetyl CoA carboxylase

remmers. De IRAC code is 23. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van

resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te

volgen.

3.2 Conclusions

An authorisation for the extension of the label can be granted except for the control in carrot of Semiaphis

dauci, Aphis spp (restricted to Cavariella aegopodii) and Trioza apicalis.

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

Part A



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Date November 2018

Appendix 1 Copy of the product label

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

Toepassingsgebied

Type toepassing

Werkzaamheid getoetst op

Dosering* middel per toepassing

Maximale dosering per toepassing

Maximaal aantal toepassingen per teeltcyclus of per 12 maanden

Maximaal aantal liter middel per ha per teeltcyclus of per 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen

Aardappelen Gewasbehandeling na de bloei

Bladluis2,5 0,5 L/ha 0,5 L/ha

2 per teeltcyclus

1 L/ha per teeltcyclus

7 14

Witlof (pennenteelt)

Gewasbehandeling

Bladluis5

0,5 L/ha 0,5

L/ha 2 per 12 maanden

1 L/ha per 12 maanden

14 70

Appel (onbedekte teelt)

Gewasbehandeling na de bloei

Bladluis7,8,9,10 0,05% (50 ml middel per 100 liter water)

0,75 L/ha

2 per 12 maanden


14

21

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Toepassingsgebied

Type toepassing








Appelbloedluis1

1 0,1% (100 ml middel per 100 liter water)

1,0 L/ha

Peer (onbedekte teelt)


Bladluis7,10,12,13,

14 0,05% (50 ml middel per 100 liter water)

0,6 L/ha

2 per 12 maanden


14 21

Bladvlo15 0,1% (100 ml middel per 100 liter water)

1,0 L/ha

Kers (onbedekte teelt)


Bladluis16 0,05% (50 ml middel per 100 liter water)

0,75 L/ha

2 per 12 maanden

1,5 L/ha per 12 maanden

14 21

Pruim (onbedekte teelt)


Bladluis17,18,19 0,05% (50 ml middel per 100 liter water)

0,75 L/ha

2 per 12 maanden


14 21

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Toepassingsgebied

Type toepassing








Aardbei (onbedekte teelt)

Gewasbehandeling tot 14 dagen voor de bloei

Bladluis1,4,5,6,17,

20,21,22,23,24,25 0,5 L/ha 0,5



14 -

Sla Lactuca spp. (onbedekte teelt)

Gewasbehandeling

Bladluis5,21,24,26

0,5 L/ha 0,5



14 7

Andijvie (onbedekte teelt)

Gewasbehandeling

Bladluis5,21,24,26

0,5 L/ha 0,5



14 7

Spinazie-achtigen

Gewasbehandeling

Bladluis5,21,24,26

0,5 L/ha 0,5



14 7

Koolgewassen (onbedekte teelt)

Gewasbehandeling

Bladluis27 Wittevlieg28

0,5 L/ha 0,5 L/ha

2 per 12 maanden


14 3

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Toepassingsgebied

Type toepassing








Wortelen (onbedekte teelt)

Gewasbehandeling

Bladluis41 0,3 L/ha

0,3 L/ha

2 per teeltcyclus


14 21

Wortelluis42 0,5 L/ha

0,5 L/ha

Uien (onbedekte teelt)

Gewasbehandeling

Trips29 0,5 L/ha 0,5 L/ha

2 per 12 maanden


7 7

Sjalotten (onbedekte teelt)

Gewasbehandeling

Trips29 0,5 L/ha 0,5 L/ha

2 per 12 maanden


7 7

Bloembol- en bloemknolgewassen (onbedekte teelt)


Bladluis1,4,5,6,24,

30 0,5 L/ha 0,5



14 -

Boomkwekerijgewassen (onbedekte teelt)

Gewasbehandeling

Bladluis1,4,5,6,24,

31,32

0,05% (50 ml middel per 100 liter water)

0,6 L/ha

2 per 12 maanden


14 -

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Toepassingsgebied

Type toepassing








Vaste plantenteelt (onbedekte teelt)

Gewasbehandeling

Bladluis1,4,5,6,24,

33


0,5 L/ha

2 per 12 maanden


14 -

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen. 1. Aardappeltopluis (Macrosiphum euphorbiae) 2. Wegedoornluis (Aphis nasturtii) 3. Peenbladvlo (Trioza apicalis) 4. Boterbloemluis (Aulacorthum solani) 5. Groene perzikluis (Myzus persicae) 6. Zwarte bonenluis (Aphis fabae) 7. Appelgrasluis (Rhopalosiphum insertum) 8. Bloedvlekkenluis (Dysaphis devecta en D. Anthrisci) 9. Roze appelluis (Dysaphis plantaginea) 10. Groene appeltakluis (Aphis pomi) 11. Appelbloedluis (Eriosoma lanigerum) 12. Roze perenluis (Dysaphis pyri) 13. Vouwgalluis (Anuraphis farfarae) 14. Zwarte perenluis (Melanaphis pyaria)

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15. Perenbladvlo (Psylla pyri) 16. Zwarte kersenluis (Myzus cerasi) 17. Gevlekte kortstaartluis (Brachycaudus prunicola) 18. Melige perzikluis (Hyalopterus amygdali) 19. Melige pruimenluis (Hyalopterus pruni) 20. Groene melkdistelluis (Hyperomyzus lactucae) 21. Groene slaluis (Nasanovia ribisnigri) 22. Grote frambozenluis (Amphorophora idaei) 23. Aardbeiknotshaarluis (Chaetosiphon fragaefolii) 24. Katoenluis (Aphis gossypii) 25. Sjalottenluis (Myzus ascalonicus) 26. Bruine slaluis (Uroleucon sonchi) 27. Melige koolluis (Brevicoryne brassicae) 28. Koolwittevlieg (Aleyrodes brassicae) 29. Tabakstrips (Thrips tabaci) 30. Fluitekruidluis (Dysaphis anthrisci) 31. Beukenbladluis (Phyllaphis fagi) 32. Staticobium limonii (Staticobium limonii) 33. Gele rozenluis (Rhodobium porrosum) 34. Wollige slawortelluis (Pemphigus bursarius) 35. Braamgrasluis (Sitobion fragariae) 36. Grote bramenluis (Amphorophora rubi) 37. Kleine frambozenluis (Aphis idaei) 38. Bessentakluis (Rhopalosiphoninus ribesinus) 39. Bonenspint (Tetranychus urticae) 40. Californische trips (Frankliniella occidentalis) 41. Zevenbladbluis (Cavariella aegopodii) 42. Wollige peenluis (Pemphigus phenax) 43. Bladluis (Aphis spp.) 44. Kleine peenluis (Semiaphis dauci)

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

Toepassingsgebied Type toepassing

Werkzaamheid aannemelijk tegen







Aardappel Gewasbehandeling na de bloei

Mijten39

0,5 l/ha 0,5 l/ha 2 per teeltcyclus


7 14

Vezelgewassen Gewasbehandeling na de bloei

Bladluis1,4,5,6,20,24,

30,33

Wortelluis34

0,5 L/ha 0,5 L/ha 2 per teeltcyclus


14 -

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Witlof (pennenteelt) Gewasbehandeling

Wortelluis34 0,5 L/ha 0,5 L/ha 2 per 12 maanden


14 70

Cichorei Gewasbehandeling

Bladluis41,43,44 0,3 L/ha

0,3 L/ha

2 per teeltcyclus


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

Pitvruchten m.u.v. appel en peer (onbedekte teelt)


Bladluis7,8,9,10,11,12

,13 0,05% (50 ml middel per 100 liter water)

0,75 L/ha

2 per 12 maanden


14

21


Appelbloedluis11 Bladvlo15


1 L/ha

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Steenvruchten m.u.v. kers en pruim (onbedekte teelt)


Bladluis16,17,18,19 0,05% (50 ml middel per 100 liter water)

0,75 L/ha

2 per 12 maanden


14 21

Druif (onbedekte teelt)


Bladluis5 0,05% (50 ml middel per 100 liter water)

0,6 L/ha 2 per 12 maanden


14 14

Braam- en framboosachtigen (Rubus spp.) (onbedekte teelt)

Gewasbehandeling na de oogst

Bladluis17,20,22,35,3

6,37,38 0,05% (50 ml middel per 100 liter water)



14 -

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Andijvie (onbedekte teelt)

Gewasbehandeling

Wortelluis34 0,5 L/ha 0,5 L/ha 2 per 12 maanden


14 7

Veldsla (onbedekte teelt)

Gewasbehandeling

Bladluis5,21,24,26

0,5 L/ha 0,5 L/ha 2 per 12 maanden


14 7

Rucola (onbedekte teelt)

Gewasbehandeling

Bladluis5,21,24,26

0,5 L/ha 0,5 L/ha 2 per 12

maanden


14 7

Radijs-achtigen (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per 12 maanden


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

Suikerwortel (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per 12 maanden 2 per 12 maanden


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

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Wortelpeterselie (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per 12 maanden


14 21

Wortelluis42

Bladvlo3

0,5 L/ha

0,5 L/ha

Pastinaak (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per 12 maanden


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

Aardpeer (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per teeltcyclus


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

Rode biet (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per teeltcyclus


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

Knolselderij (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per teeltcyclus


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

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Schorseneer (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per teeltcyclus


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

Mierikswortel (onbedekte teelt)

Gewasbehandeling


0,3 L/ha

2 per teeltcyclus


14 21

Wortelluis42

Bladvlo3 0,5 L/ha

0,5 L/ha

Aromatische kruidgewassen (onbedekte teelt)

Gewasbehandeling op niet-bloeiende gewassen of na de bloei

Bladluis5,26

0,5 L/ha 0,5 L/ha

2 per 12 maanden


14 7

Medicinale kruidgewassen m.u.v. kamille (onbedekte teelt)

Gewasbehandeling op niet-bloeiende gewassen of na de bloei

Bladluis5,26

0,5 L/ha 0,5 L/ha 2 per 12

maanden


14 7

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Chrysant (bedekte teelt)

Gewas-behandeling

Bladluis1,4,5,6,24,33

Mijten39 Trips40



14 -

Bloemisterijgewassen (onbedekte teelt)


Bladluis1,4,5,6,24,33 0,05% (50 ml middel per 100 liter water)



14 -

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De onbedekte teelt van veredeling en bloemzaadteelt, groentenzaadteelt en zaadteelt van kruiden, bieten, peulvruchten, oliehoudende zaden, vezelgewassen, groenbemestergewassen, voedergewassen, witlof (pennenteelt), cichorei, boekweit, meekrap en olifantsgras


Bladluis1,5,6,17,20,24

,30,33



14 -

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is bij lagere dosering niet beoordeeld. 1. Aardappeltopluis (Macrosiphum euphorbiae) 2. Wegedoornluis (Aphis nasturtii)

Part A



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

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Date: November 2018

36. Grote bramenluis (Amphorophora rubi) 37. Kleine frambozenluis (Aphis idaei) 38. Bessentakluis (Rhopalosiphoninus ribesinus) 39. Bonenspint (Tetranychus urticae) 40. Californische trips (Frankliniella occidentalis) 41. Zevenbladbluis (Cavariella aegopodii) 42. Wollige peenluis (Pemphigus phenax) 43. Bladluis (Aphis spp.) 44. Kleine peenluis (Semiaphis dauci) Overige toepassingsvoorwaarden In de teelt van aardappel maximaal 2 toepassingen met 0,5 L/ha toepassen. In de teelt van pitvruchten, steenvruchten, braam- en framboosachtigen, bloemsiterijgewassen, boomkwekerijgewassen en vaste plantenteelt het middel toepassen in minimaal 1000 liter water per ha. In de teelt van druif het middel toepassen in 1200 liter water per ha. Behandelde vezelgewassen en producten hiervan niet voor menselijke en/of dierlijke consumptie bestemmen. Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit product niet gebruiken op in bloei-staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen en hommels. Gebruik dit product niet wanneer bloeiende onkruiden aanwezig zijn. Verwijder onkruid voordat het bloeit. Na een gewasbehandeling percelen nog minimaal twee weken vrijhouden van bloeiende onkruiden. Voor bedekte teelten geldt dat gebruik wel is toegestaan op bloeiende planten mits er geen bijen of hommels in de kas actief naar voedsel zoeken. Voorkom dat bijen en andere bestuivende insecten de kas binnenkomen door bijvoorbeeld alle openingen met insectengaas af te sluiten. Gebruik in de onbedekte teelt van aromatische of medicinale kruidgewassen (m.u.v. kamille) is alleen toegestaan wanneer deze in het veld niet tot bloei komen. In de onbedekte teelt van aromatische of medicinale kruidgewassen (m.u.v. kamille) die wel tot bloei komen is gebruik alleen na de bloei toegestaan.

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Date: November 2018

Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in een dosering tot maximaal 1,0 L/ha in de teelt van appel, peer, kers, pruim en overige pit- en steenvruchten uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT99, of DRT97,5 in combinatie met een teeltvrije zone van 450 centimeter (gemeten vanaf het midden van de laatste bomenrij of de laatste boom in de rij tot aan de perceelgrens). Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in een dosering tot maximaal 0,75 L/ha in de teelt van appel, peer, kers, pruim en overige pit- en steenvruchten, maximaal 0,6 L/ha in de teelt van druif en maximaal 0,5 L/ha in de teelt braam- en framboosachtigen uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT97,5, of DRT95 in combinatie met een teeltvrije zone van 450 centimeter (gemeten vanaf het midden van de laatste bomenrij/struikrij of de laatste boom/struik in de rij tot aan de perceelgrens). Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten te beschermen is toepassing van dit middel in de teelt van vezelgewassen, witlof, aardbei, sla, andijvie, spinazie-achtigen, koolgewassen, uien, sjalotten, aardappelen, bloembol- en bloemknolgewassen, vaste plantenteelt, veldsla, rucola, aromatische kruidgewassen, medicinale kruidgewassen met uitzondering van kamille, bloemisterijgewassen, boomkwekerijgewassen (neerwaarts bespoten), aardappelen, wortelen, chicorei, radijs-achtigen, suikerwortel, wortelpeterselie, pastinaak, aardpeer, rode biet, knolselderij, schorseneer en mierikswortel, en de teelt van veredeling en zaadteelt van diverse gewassen uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van één van de volgende maatregelen: Zonder luchtondersteuning: - Veldspuit met verlaagde spuitboom in combinatie met spuitdoppen van tenminste DRD50% met een tophoek van maximaal 90˚ en bijbehorende driftarme kantdop met spuitdopafstand 25 cm en spuitdophoogte maximaal 30 cm in combinatie met een teeltvrije zone van 150 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - sleepdoek spuitsysteem met spuitdoppen met tenminste druppelgrootte F en een kantdop met tenminste druppelgrootte F bij een spuitdophoogte van maximaal 20 cm in combinatie met een teeltvrije zone van 175 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - sleepdoek spuitsysteem met spuitdoppen met tenminste DRD50 en een kantdop met tenminste DRD50% bij een spuitdophoogte van maximaal 20 cm in combinatie met een teeltvrije zone van 150 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - Tunnelspuit voor beddenteelt (=overkapte beddenspuit) in combinatie met spuitdoppen met een tophoek van 110-120° en tenminste druppelgrootte M en een kantdop aan beide kanten van de spuit met tenminste druppelgrootte M;

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- Veldspuit met spuitdoppen met tenminste DRD75% en een kantdop met tenminste DRD75% in combinatie met een teeltvrije zone van 225 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens). Met luchtondersteuning: - Veldspuit met spuitdoppen met tenminste DRD75% en een kantdop met tenminste DRD75% in combinatie met een teeltvrije zone van 200 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - veldspuit met verlaagde spuitboom in combinatie met een spuitdophoogte van maximaal 30 cm met een dopafstand 25 cm en spuitdoppen tenminste DRD 50% met een tophoek van maximaal 90° en bijbehorende driftarme kantdop in combinatie met een teeltvrije zone van 150 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens); - Hardi Twin Force luchtondersteunde veldspuit in combinatie met spuitdoppen van tenminste DRD 50% en bijbehorende driftarme kantdop bij een rijsnelheid van maximaal 12 km/u g; - Hardi Twin Force luchtondersteunde veldspuit en bijbehorende driftarme kantdop bij een rijsnelheid van maximaal 12 km/u in combinatie met een teeltvrije zone van 225 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens). Om niet tot de doelsoorten behorende insecten/geleedpotigen, bijen en andere bestuivende insecten en terrestrische planten te beschermen is toepassing van dit middel in de teelt van hoge laanbomen uitsluitend toegestaan indien op het gehele perceel gebruikt gemaakt wordt van een techniek uit tenminste de klasse DRT50 in combinatie met een totale teeltvrije zone van 700 centimeter (gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij tot aan de perceelgrens).

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

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. Gevoeligheid gewassen In een aantal appelrassen kan het middel fytotoxiciteit geven.

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Date: November 2018

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

Part A


MOVENTO

Appendix 2 – Letter of Access

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

Part A



of 56

Date November 2018

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

Physical chemical properties and analytical methods

Annex point / reference number

Year Title Source (where different from company) Company name, Report No., Date, GLP/GEP status (where relevant), published or not

Data protect. claimed

Data protection granted Y/N

Relied on Y/N Owner

KIIIA 2.5.3 /01 KIIIA 2.7.1 /01 KIIIA 2.8.3.1 /01

2015 Content, colour, odour, physical state, surface tension (only before storage) and suspension before and after storage at elevated temperature of spirotetramat OD 150 (150 g/L) - Packaging material: COEX/PA - Final report (14 days) - 1. Amendment Bayer CropScience, Report No.: FM0222(ACR02)N01, Edition Number: M-514148-02-1 Date: 2015-03-20 ...Amended: 2015-05-06 GLP/GEP: no, unpublished ...also filed: KIIIA 2.7.1 /01

...also filed: KIIIA 2.8.3.1 /01

Yes Y Y Bayer CropScience

Part A



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Date: November 2018

Residue and Metabolism

Annex point /

reference number Year

Title

Source (where different from company)

Company name, Report No., Date, GLP/GEP

status (where relevant), published or not

Data protection

claimed

Yes /

No

Study relied on

Yes / No

Data protection

granted

Yes /

No

Owner

KIIIA 8.3.1/01 2014 Determination of the residues of BYI 08330

in/on carrot after spray application of

Spirotetramat SC 100 in the field in Germany,

the Netherlands and Belgium

Report No.: 12-2141,

Report includes Trial Nos.:

12-2141-01, and -04

Edition Number: M-483133-01-1

Date: 2014-04-07

GLP/GEP: yes, unpublished

Yes Yes Yes

Bayer CropScience

KIIIA 8.3.1/02 2014 Determination of the residues of BYI 08330

in/on carrot after spray application of

Spirotetramat SC 100 in Germany, the

Netherlands and Belgium

Report No.: 13-2052,

Report includes Trial Nos.:

13-2052-01, and -04


Date: 2014-12-16

GLP/GEP: yes, unpublished

Yes Yes Yes

Bayer CropScience

Fate and behaviour

Part A



of 56


Date: November 2018

Annex point /

reference number

Year Title




Data protect.

claimed

Owner Studies relied on

Y/N

Data protection

granted

Y/N

KIIIA 9.6.1/01 2015 Spirotetramat (SPT) PECgw NLD: Predicted

environmental concentrations in groundwater

based on calculations with GeoPEARL 3.3.3

Bayer CropScience,

Report No.: EnSa-15-0230,


Date: 2015-03-24

GLP/GEP: no, unpublished

...also filed: KIIIA 9.6.2 /01

No Bayer CropScience Y N

KIIIA 9.6.1 /02 2015 SPT core PECgw EU: Modelling core info

document for groundwater risk assessment in

Europe

Bayer CropScience,



Date: 2015-03-18




KIIIA 9.6.2 /01 2015 Spirotetramat (SPT) PECgw NLD: Predicted

environmental concentrations in groundwater

based on calculations with GeoPEARL 3.3.3

Bayer CropScience,



Date: 2015-03-24




Part A



of 56


Date: November 2018

Annex point /

reference number

Year Title




Data protect.

claimed


Y/N

Data protection

granted

Y/N

KIIIA 9.6.2 /02 2015 SPT core PECgw EU: Modelling core info

document for groundwater risk assessment in

Europe

Bayer CropScience,



Date: 2015-03-18




KIIIA 9.7 /01 2015 Spirotetramat (SPT) and metabolites NL:

Predicted environmental concentrations in surface

water (PECsw) and sediment (PECsed) based on

calculations with TOXSWA - Use in carrot in the

Netherlands

Bayer CropScience,



Date: 2015-03-31


...also filed: KIIIA 9.8 /01


KIIIA 9.7 /02 2015 Spirotetramat core PECsw: Modelling core info

document for surface water risk assessment in the

Netherland

Bayer CropScience,



Date: 2015-03-18




Part A



of 56


Date: November 2018

Annex point /

reference number

Year Title




Data protect.

claimed


Y/N

Data protection

granted

Y/N

KIIIA 9.8 /01 2015 Spirotetramat (SPT) and metabolites NL:

Predicted environmental concentrations in surface

water (PECsw) and sediment (PECsed) based on

calculations with TOXSWA - Use in carrot in the

Netherlands

Bayer CropScience,



Date: 2015-03-31




KIIIA 9.8 /02 2015 Spirotetramat core PECsw: Modelling core info

document for surface water risk assessment in the

Netherland

Bayer CropScience,



Date: 2015-03-18




Efficacy

Part A



of 56


Date: November 2018

Annex point

Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Data protect-tion claimed Y/N

Data protect-tion grantedY/N

used for evalua-tion y/N

Owner

KIIIA 6 /01 2015 Summary of the efficacy data and information on the plant protection product for spirotetramat OD 150 (150 g/L) Bayer CropScience Bayer CropScience, Report No.: M-524277-01-1, Edition Number: M-524277-02-1 Date: 2015-05-21 GLP/GEP: n.a., unpublished

No No Y Bayer CropScience

KIIIA 6.1.2 /01 2015 Compilation of trial report for spirotetramat OD150 - Minimum effective dose and efficacy trials - Carrots - Central zone Bayer CropScience, Belgium Bayer CropScience, Report No.: M-520795-01-1, Edition Number: M-520795-01-1 Date: 2015-05-15 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.3 /01 ...also filed: KIIIA 6.2.1 /01

Yes Yes Y Bayer CropScience



Part A



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Date: November 2018

Annex point





Owner

KIIIA 6.1.4.2 /01 2015 Compilation of trial report for SPT SC100 - Effects on the processing procedure - carrot Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: M-515790-01-1, Report includes Trial Nos.: SRFR13-399-07IE Edition Number: M-515790-01-1 Date: 2015-04-03 GLP/GEP: yes, unpublished


KIIIA 6.1.4.2 /02 2015 Compilation of trial report for SPT OD150 (150 g/L)- Effects on the processing procedure - Carrot Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: M-519323-01-1, Report includes Trial Nos.: 07SRX14E2-9 - ARI-14-D-089-01 Edition Number: M-519323-01-1 Date: 2015-05-04 GLP/GEP: yes, unpublished


KIIIA 6.1.4.3 /01 2015 Compilation of trial report for spirotetramat OD150 - Plant safety and Yield on carrots free of pests - Central zone Bayer CropScience, Belgium Bayer CropScience, Report No.: M-520800-01-1, Edition Number: M-520800-01-1 Date: 2015-05-15 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.2.1 /02


Part A



of 56


Date: November 2018

Annex point





Owner



KIIIA 6.2.1 /02 2015 Compilation of trial report for spirotetramat OD150 - Plant safety and Yield on carrots free of pests - Central zone Bayer CropScience, Belgium Bayer CropScience, Report No.: M-520800-01-1, Edition Number: M-520800-01-1 Date: 2015-05-15 GLP/GEP: yes, unpublished ...also filed: KIIIA 6.1.4.3 /01


KIIIA 6.2.8 /01 2012 Resistance statement - Information on the occurrence or possible occurrence of the development of resistance for MOVENTO containing the active substance 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


KIIIA 6.2.8 /02 2012 Resistance statement (central zone) - Information on the occurrence or possible occurrence of the development of resistance for MOVENTO containing the active substance spirotetramat Bayer CropScience Bayer CropScience, Report No.: M-435829-01-1, Edition Number: M-435829-01-1 Date: 2012-08-03 GLP/GEP: n.a., unpublished


Part A



of 56


Date: November 2018

Annex point





Owner

KIIIA 6.2.8 /02 2017 Resistance Statement - Addendum Information on the occurrence or possible occurrence of the development of resistance for MOVENTO® SC100 and OD150 containing the active substance Spirotetramat Bayer CropScience Date: 2017-03-09 GLP/GEP: n.a., unpublished


HET COLLEGE VOOR DE TOELATING VAN ......13404 N Movento, 20152034 NLWTG HET COLLEGE VOOR DE...

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