HET COLLEGE VOOR DE TOELATING VAN ......13404 N Movento, 20152034 NLWTG HET COLLEGE VOOR DE...
Transcript of 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
Movento, 20152034 NLWTG
� 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
Movento, 20152034 NLWTG
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
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Movento, 20152034 NLWTG
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
Movento, 20152034 NLWTG
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
Page 6 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
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 7 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 8 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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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MOVENTO Registration Report – Central Zone
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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 10 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 11 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 12 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 13 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
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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
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
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
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
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
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
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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MOVENTO Registration Report – Central Zone
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Date: November 2018
15 Netherla
nds
Red beet BEAVD 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
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
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
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,
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
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
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
Part A
National Assessment - Netherlands
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Page 16 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
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
Part A
National Assessment - Netherlands
MOVENTO
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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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Date: November 2018
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)
ZRMS Austria did not provide a core assessment for the aspect fate and behaviour, because it was
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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Date: November 2018
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)
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ZRMS Austria did not provide a core assessment for the aspect fate and behaviour, because it was
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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Date: November 2018
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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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
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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
2 L/ha per 12 maanden
14
21
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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
Appelbloedluis1
1 0,1% (100 ml middel per 100 liter water)
1,0 L/ha
Peer (onbedekte teelt)
Gewasbehandeling na de bloei
Bladluis7,10,12,13,
14 0,05% (50 ml middel per 100 liter water)
0,6 L/ha
2 per 12 maanden
2 L/ha per 12 maanden
14 21
Bladvlo15 0,1% (100 ml middel per 100 liter water)
1,0 L/ha
Kers (onbedekte teelt)
Gewasbehandeling na de bloei
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)
Gewasbehandeling na de bloei
Bladluis17,18,19 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
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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
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
L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 -
Sla Lactuca spp. (onbedekte teelt)
Gewasbehandeling
Bladluis5,21,24,26
0,5 L/ha 0,5
L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 7
Andijvie (onbedekte teelt)
Gewasbehandeling
Bladluis5,21,24,26
0,5 L/ha 0,5
L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 7
Spinazie-achtigen
Gewasbehandeling
Bladluis5,21,24,26
0,5 L/ha 0,5
L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 7
Koolgewassen (onbedekte teelt)
Gewasbehandeling
Bladluis27 Wittevlieg28
0,5 L/ha 0,5 L/ha
2 per 12 maanden
1 L/ha per 12 maanden
14 3
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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
Wortelen (onbedekte teelt)
Gewasbehandeling
Bladluis41 0,3 L/ha
0,3 L/ha
2 per teeltcyclus
1 L/ha 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
1 L/ha per 12 maanden
7 7
Sjalotten (onbedekte teelt)
Gewasbehandeling
Trips29 0,5 L/ha 0,5 L/ha
2 per 12 maanden
1 L/ha per 12 maanden
7 7
Bloembol- en bloemknolgewassen (onbedekte teelt)
Gewasbehandeling na de bloei
Bladluis1,4,5,6,24,
30 0,5 L/ha 0,5
L/ha 2 per 12 maanden
1 L/ha per 12 maanden
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
1,2 L/ha per 12 maanden
14 -
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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
Vaste plantenteelt (onbedekte teelt)
Gewasbehandeling
Bladluis1,4,5,6,24,
33
0,05% (50 ml middel per 100 liter water)
0,5 L/ha
2 per 12 maanden
1 L/ha 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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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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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Date: November 2018
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
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
Aardappel Gewasbehandeling na de bloei
Mijten39
0,5 l/ha 0,5 l/ha 2 per teeltcyclus
1 L/ha 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
1 L/ha per teeltcyclus
14 -
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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
Toepassingsgebied Type toepassing
Werkzaamheid aannemelijk tegen
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
Witlof (pennenteelt) Gewasbehandeling
Wortelluis34 0,5 L/ha 0,5 L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 70
Cichorei Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per teeltcyclus
1 L/ha per teeltcyclus
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
Pitvruchten m.u.v. appel en peer (onbedekte teelt)
Gewasbehandeling na de bloei
Bladluis7,8,9,10,11,12
,13 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
Gewasbehandeling na de bloei
Appelbloedluis11 Bladvlo15
0,1% (100 ml middel per 100 liter water)
1 L/ha
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Date: November 2018
Toepassingsgebied Type toepassing
Werkzaamheid aannemelijk tegen
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
Steenvruchten m.u.v. kers en pruim (onbedekte teelt)
Gewasbehandeling na de bloei
Bladluis16,17,18,19 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
Druif (onbedekte teelt)
Gewasbehandeling na de bloei
Bladluis5 0,05% (50 ml middel per 100 liter water)
0,6 L/ha 2 per 12 maanden
1,2 L/ha 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)
0,5 L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 -
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Date: November 2018
Toepassingsgebied Type toepassing
Werkzaamheid aannemelijk tegen
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
Andijvie (onbedekte teelt)
Gewasbehandeling
Wortelluis34 0,5 L/ha 0,5 L/ha 2 per 12 maanden
1 L/ha 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
1 L/ha 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
1 L/ha per 12 maanden
14 7
Radijs-achtigen (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per 12 maanden
1 L/ha per 12 maanden
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
Suikerwortel (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per 12 maanden 2 per 12 maanden
1 L/ha per 12 maanden
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
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Toepassingsgebied Type toepassing
Werkzaamheid aannemelijk tegen
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
Wortelpeterselie (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per 12 maanden
1 L/ha per 12 maanden
14 21
Wortelluis42
Bladvlo3
0,5 L/ha
0,5 L/ha
Pastinaak (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per 12 maanden
1 L/ha per 12 maanden
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
Aardpeer (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per teeltcyclus
1 L/ha per teeltcyclus
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
Rode biet (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per teeltcyclus
1 L/ha per teeltcyclus
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
Knolselderij (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per teeltcyclus
1 L/ha per teeltcyclus
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
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MOVENTO Registration Report – Central Zone
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Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
Toepassingsgebied Type toepassing
Werkzaamheid aannemelijk tegen
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
Schorseneer (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per teeltcyclus
1 L/ha per teeltcyclus
14 21
Wortelluis42
Bladvlo3 0,5 L/ha
0,5 L/ha
Mierikswortel (onbedekte teelt)
Gewasbehandeling
Bladluis41,43,44 0,3 L/ha
0,3 L/ha
2 per teeltcyclus
1 L/ha 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
1 L/ha 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
1 L/ha per 12 maanden
14 7
Part A
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MOVENTO Registration Report – Central Zone
Page 40 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
Toepassingsgebied Type toepassing
Werkzaamheid aannemelijk tegen
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
Chrysant (bedekte teelt)
Gewas-behandeling
Bladluis1,4,5,6,24,33
Mijten39 Trips40
0,5 L/ha 0,5 L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 -
Bloemisterijgewassen (onbedekte teelt)
Gewasbehandeling na de bloei
Bladluis1,4,5,6,24,33 0,05% (50 ml middel per 100 liter water)
0,5 L/ha 2 per 12 maanden
1 L/ha per 12 maanden
14 -
Part A
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MOVENTO Registration Report – Central Zone
Page 41 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
Toepassingsgebied Type toepassing
Werkzaamheid aannemelijk tegen
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
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
Gewasbehandeling na de bloei
Bladluis1,5,6,17,20,24
,30,33
0,5 L/ha 0,5 L/ha 2 per 12 maanden
1 L/ha 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 bij lagere dosering niet beoordeeld. 1. Aardappeltopluis (Macrosiphum euphorbiae) 2. Wegedoornluis (Aphis nasturtii)
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Date: November 2018
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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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
National Assessment - Netherlands
MOVENTO
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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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
Edition Number: M-506733-01-1
Date: 2014-12-16
GLP/GEP: yes, unpublished
Yes Yes Yes
Bayer CropScience
Fate and behaviour
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Date: November 2018
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
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,
Edition Number: M-517894-01-1
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,
Report No.: EnSa-15-0213,
Edition Number: M-514274-01-1
Date: 2015-03-18
GLP/GEP: no, unpublished
...also filed: KIIIA 9.6.2 /02
No Bayer CropScience Y N
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,
Report No.: EnSa-15-0230,
Edition Number: M-517894-01-1
Date: 2015-03-24
GLP/GEP: no, unpublished
...also filed: KIIIA 9.6.1 /01
No Bayer CropScience Y N
Part A
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 51 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
Owner Studies relied on
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,
Report No.: EnSa-15-0213,
Edition Number: M-514274-01-1
Date: 2015-03-18
GLP/GEP: no, unpublished
...also filed: KIIIA 9.6.1 /02
No Bayer CropScience Y N
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,
Report No.: EnSa-15-0263,
Edition Number: M-517915-01-1
Date: 2015-03-31
GLP/GEP: no, unpublished
...also filed: KIIIA 9.8 /01
No Bayer CropScience Y N
KIIIA 9.7 /02 2015 Spirotetramat core PECsw: Modelling core info
document for surface water risk assessment in the
Netherland
Bayer CropScience,
Report No.: EnSa-15-0219,
Edition Number: M-514355-01-1
Date: 2015-03-18
GLP/GEP: no, unpublished
...also filed: KIIIA 9.8 /02
No Bayer CropScience Y N
Part A
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 52 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
Date: November 2018
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
Owner Studies relied on
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,
Report No.: EnSa-15-0263,
Edition Number: M-517915-01-1
Date: 2015-03-31
GLP/GEP: no, unpublished
...also filed: KIIIA 9.7 /01
No Bayer CropScience Y N
KIIIA 9.8 /02 2015 Spirotetramat core PECsw: Modelling core info
document for surface water risk assessment in the
Netherland
Bayer CropScience,
Report No.: EnSa-15-0219,
Edition Number: M-514355-01-1
Date: 2015-03-18
GLP/GEP: no, unpublished
...also filed: KIIIA 9.7 /02
No Bayer CropScience Y N
Efficacy
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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
KIIIA 6.1.3 /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 6.1.2 /01 ...also filed: KIIIA 6.2.1 /01
Yes Yes Y Bayer CropScience
Part A
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 54 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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 6.1.4.2 /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
Yes Yes Y Bayer CropScience
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
Yes Yes Y Bayer CropScience
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
Yes Yes Y Bayer CropScience
Part A
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 55 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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 6.2.1 /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 6.1.2 /01 ...also filed: KIIIA 6.1.3 /01
Yes Yes Y Bayer CropScience
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
Yes Yes Y Bayer CropScience
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
No No Y Bayer CropScience
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
No No Y Bayer CropScience
Part A
National Assessment - Netherlands
MOVENTO Registration Report – Central Zone
Page 56 of 56
Applicant: Bayer CropScience S.A.-N.V. Evaluator: Ctgb, NL
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 6.2.8 /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
No No Y Bayer CropScience