HET COLLEGE VOOR DE TOELATING VAN ......14437 N Luna Sensation, 20146203 ZWTG HET COLLEGE VOOR DE...

14437 N

Luna Sensation, 20146203 ZWTG

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT

Op 3 augustus 2015 is van

Bayer CropScience S.A.-N.V.

Postbus 231

3640 AE MIJDRECHT

een aanvraag tot wijziging van een gewasbeschermingsmiddeltoelating met Nederland als

zonaal rapporteur ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te

noemen: de Verordening) voor het gewasbeschermingsmiddel

Luna Sensation

op basis van de werkzame stoffen trifloxystrobin, fluopyram.

HET COLLEGE BESLUIT tot toelating van bovenstaand middel.

Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk

onderdeel van dit besluit.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als

waarvoor de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en

zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende

aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te

worden vermeld:

14437 N


� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder

“verpakkingsinformatie” in bijlage I.

� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen

in deel A van het registratierapport, Appendix I.

� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

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

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

hoofdstuk 2 van deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

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 28 Verordening (EG) Nr. 1107/2009

Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009

Gebruikt toetsingskader Conform 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.

14437 N


Bezwaarmogelijkheid

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de

Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes

weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College

voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.

Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift

opengesteld.

Ede, 30 juli 2018

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

Ir. J.F. de Leeuw

Voorzitter

14437 N


BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20146203 ZWTG

Type aanvraag: Aanvraag tot wijziging van

gewasbeschermingsmiddeltoelating met Nederland

als zonaal rapporteur

Middelnaam: Luna Sensation

Verzenddatum aanvraag: 30 juli2015

Formele registratiedatum: * 8 oktober 2015

Datum in behandeling name: 25 augustus 2016

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

2.2 Stofinformatie

Werkzame stof Gehalte

fluopyram 250 G/L

trifloxystrobin 250 G/L

• De stof fluopyram is per 1 februari 2014 goedgekeurd volgens Vo. (EG) Nr. 1107/2009

(Regulation (EU) 802/2013 d.d. 22 augustus 2013). De goedkeuring van deze

werkzame stof expireert op 31 januari 2024

• De stof trifloxystrobin is per 1 oktober 2003 geplaatst op Annex I van Richtlijn

91/414/EEG (Directive 2003/68/EC d.d. 11 juli 2003) en vervolgens bij

Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd). De

goedkeuring van deze werkzame stof expireert op 31 juli 2018.

2.3 Toelatingsinformatie

Toelatingsnummer: 14437 N

Expiratiedatum: 30 april 2024

Afgeleide parallel of origineel: Origineel

Biocide, gewasbeschermingsmiddel of

toevoegingsstof:

Gewas

Gebruikers: Professioneel

W-coderingen en aflever- en opgebruiktermijnen:

� W-codering professioneel gebruik: W3

� Vorige w-codering professioneel gebruik: W2

� Aflevertermijn professioneel gebruik: n.v.t.

� Opgebruiktermijn professioneel gebruik: n.v.t.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:225:0013:0016:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:177:0012:0016:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:153:0001:0186:NL:PDF

14437 N


2.4 Verpakkingsinformatie

Aard van het preparaat:

Suspensie concentraat

14437 N


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel Luna Sensation

Professioneel gebruik

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

Pictogram GHS07

GHS09

Signaalwoord Waarschuwing

Gevarenaanduidingen H302 Schadelijk bij inslikken.

H410 Zeer giftig voor in het water levende organismen, met

langdurige gevolgen.

Voorzorgsmaatregelen P280 Beschermende handschoenen/beschermende

kleding/oogbescherming/gelaatsbescherming dragen.

P501 Inhoud/verpakking afvoeren naar ....

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

water verontreinigt.

Aanvullende

etiketelementen

EUH208 Bevat trifloxystrobin, 1,2-benzisothiazol-3(2H)-on,

mengsel van: 5-chloor-2-methyl-2H-isothiazool-3-on en 2-methyl-

2Hisothiazool-3-on (3:1). Kan een allergische reactie veroorzaken.

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 addendum – The Netherlands

Luna Sensation Registration Report – central zone/ Inter

zones of 118

Applicant: Bayer CropScience Evaluator: NL, Ctgb

Date: July 2018

REGISTRATION REPORT

Part A

Risk Management

Product code: 102000012886

Product name: Luna Sensation

Active Substances: Fluopyram + Trifloxystrobin

SC 500 (250+250 g/L)

The Netherlands

Zonal Rapporteur Member State: The Netherlands

NATIONAL ASSESSMENT

Applicant: Bayer CropScience

Date: July 2018

Part A



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Date: July 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



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Date: July 2018

Table of Contents

PART A – Risk Management ..................................................................................................... 11

1 Details of the application ..................................................................................... 11

1.1 Application background ...................................................................................... 11

1.2 Annex I inclusion ................................................................................................. 11

1.3 Regulatory approach ........................................................................................... 12

1.4 Data protection claims ......................................................................................... 12

1.5 Letters of Access .................................................................................................. 13

2 Details of the authorisation ................................................................................. 13

2.1 Product identity ................................................................................................... 13

2.2 Classification and labelling ................................................................................. 13

2.2.1 Classification and labelling according to Reg. (EU) 1272/2008 ....................... 13

Other phrases ............................................................................................................................... 14

Product uses applied for ............................................................................................................. 15

3 Risk management ................................................................................................ 26

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

Uniform Principles .............................................................................................. 26

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) ............ 26

3.1.2 Methods of analysis (Part B, Section 2, Point 5) ............................................... 26

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) ............ 26

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) ............. 26

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) ........................................ 27

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) ..................................................... 27

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) ............................................. 27

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) ........................................... 29

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) ............................................... 29

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) ...................... 30

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) ................................................ 30

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) .......................................... 34

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) ...................... 35

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

Points 9.4 and 9.5) ................................................................................................ 35

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Date: July 2018

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

Section 5, Point 9.6) ............................................................................................. 35

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

Section 5, Points 9.7 and 9.8) .............................................................................. 36

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

Point 9.9) ............................................................................................................... 37

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) ....................................................... 37

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) . 37

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) ............................... 38

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

and 10.5) ............................................................................................................... 39

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

Point 10.6) ............................................................................................................. 39

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) ............ 39

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) . 39

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

and Fauna) (Part B, Section 6, Point 10.8) ........................................................ 40

3.2 Conclusions ........................................................................................................... 40

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 .............. 41

Appendix 1 – Copy of the product authorisation ..................................................................... 42

Appendix 2 – Copy of the product label .................................................................................... 43

Appendix 3 – Letter of Access .................................................................................................... 50

Appendix 4 – List of data submitted in support of the evaluation ......................................... 51

Part A



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Date: July 2018

PART A – Risk Management

This document describes the acceptable use conditions required for the registration of Luna Sensation

containing fluopyram and trifloxystrobin in the Netherlands.

The risk assessment conclusions are based on the information, data and assessments provided in

Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for The

Netherlands.

The assessments for the safe use of Luna Sensation have been made using endpoints agreed in the EU

review of fluopyram and trifloxystrobin.

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

registration of Luna SEnsation on new crops/uses.

Appendix 1 of this document provides if available a copy of the final product authorisation in The

Netherlands.

Appendix 2 of this document is a copy of the proposed label for The Netherlands.

Appendix 3 of this document contains copies of the letters of access to the protected data / third party data

that was needed for evaluation of the formulation.

Appendix 4 of this document provides a list of data in support of the evaluation

1 Details of the application

1.1 Application background

This application is submitted by Bayer CropScience SA-NV on July 2015.

The application is for approval of Luna Sensation, a suspension concentrate containing 250 g/L

fluopyram and 250 g/L trifloxystrobin for use as a fungicide on chicory witloof, berries (blueberry, small

cranberry, currant –red, black and white, gooseberry, mulberry, rosehip, kiwiberry, elderberry),

Blackberry and raspberry family (Rubus spp., blackberry, raspberry, common dewberry) endive, sea-

aster, rocket, lamb’s lettuce, garden cress, beans and peas in fields or/and Glasshouses.

Name: Bayer CropScience SA-NV

Address: Energieweg 1

P.O. Box 231

NL-3640 AE Mijdrecht

Netherlands

This document presents the risk assessment conclusions for the plant protection product Luna Sensation,

Specification 102000012886 version 04

1.2 Annex I inclusion

Fluopyram was approved into Annex I of Regulation (EC) No1107/2009, Commission Implementing

Regulation (EU) No. 802/2013, dated 22 August 2013 with the entry into force of 1 February 2014.

Part A



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Date: July 2018

The EFSA conclusion of the peer review (EFSA Journal 2013; 11(4): 3052) and the Review Report for

fluopyram (SANCO/11456/2013 rev 2: draft, finalised on 16 July 2013) are considered to provide the

relevant scientific information for the review of the product.

The approval Regulation for fluopyram (802/2013/EC) provides some 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 fluopyram and in particular Appendices I and II

thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013

shall be taken into account.

In this overall assessment Member States must pay particular attention to:

the risk to birds and aquatic organisms. Conditions of use shall include risk mitigation measures where

appropriate.

These concerns were all addressed in the submission.

Trifloxystrobin was included into Annex I of Directive 91/414 on 11 July 2003 (Directive 2003/68/EC).

The Review Report and EFSA Scientific Report for trifloxystrobin (SANCO/4339/2000 (final – 7 April

2003) is considered to provide the relevant scientific information for the review of the product.

The Annex I Inclusion Directive for trifloxystrobin provides specific provisions under Part B which need

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

authorisation.

For the implementation of the uniform principles of Annex VI, the conclusions of the review reports on

the active substance trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or

climate conditions. Risk mitigation measures should be applied and/or monitoring programmes may be

initiated where appropriate

These concerns were all addressed in the submission.

1.3 Regulatory approach

This application is submitted in extend the registration of this products on new crops/uses in the

Netherlands.

1.4 Data protection claims

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

application, clearly identifying the new studies submitted as well as the studies for which a claim for data

protection is made. The claim for protection of studies submitted for the first authorisation of Fluopyram

should continue to apply and additionally, based on Article 59 of Regulation 1107/2009, Bayer

CropScience claims 10 years protection for the studies and reports which are now being submitted to The

Netherlands for the first time. 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.

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Date: July 2018

1.5 Letters of Access

Fluopyram and trifloxystrobin are active substances whose notifier is Bayer CropScience. No letter of

access is required as Bayer CropScience is the owner of all studies.

2 Details of the authorisation

2.1 Product identity

Product Name Trade name: Luna Sensation

Fluopyram + Trifloxystrobin SC 500 (250+250 g/L)

Specification n° 102000012886

Authorization Number

(for re-registration)

14437N

Function Fungicide

Applicant Bayer CropScience B.V.

Composition 250 g/L fluopyram + 250 g/L trifloxystrobin

Formulation type Suspension concentrate [Code: SC]

Packaging Monolayer blow-moulded HDPE container

1 to 10 liters

Opening: Bottle 1 liter: KS 50 (DIN 6063, 50

mm)

Container 5 & 10 liters: ECPA 63 (ECPA 63 mm

Standard)

Closure: HF seal (or internal wad). Injection

moulded, polyethylene or polypropylene copolymer

Compliance: Primary packaging is in compliance

with FAO Guidelines.

2.2 Classification and labelling

2.2.1 Classification and labelling according to Reg. (EU) 1272/2008

The current classification and labelling can be maintained.

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

mixture *:

-

Pictogram: GHS07 Signal word: Warning

GHS09

H-statements: H302 Harmful if swallowed.

H410 Very toxic to aquatic life with long lasting effects.

P-statements: P280 Wear protective gloves/protective clothing/eye

protection/face protection.

P501 Dispose of contents/container to hazardous or

special waste collection point.

Supplemental Hazard EUH208 Contains trifloxystrobin, 1,2-benzisothiazol-3(2H)-

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Date: July 2018

information: one and mixture of 3(2H)-isothiazolone, 5-chloro-

2-methyl-, mixture with 2-methyl-3(2H)-

isothiazolone. May produce an allergic reaction.

EUH401 To avoid risks to human health and the

environment, comply with the instructions for use.

SP1 Do not contaminate water with the product or its

container.

Child-resistant fastening obligatory? Not applicable

Tactile warning of danger obligatory? Not applicable

Other phrases

Cardoons, celeries, Florence fennels and crops belonging to the category “other stem vegetables”

cannot be allowed as succeeding crops (‘In verband met residuen in volggewassen in het

eerstvolgende teeltseizoen geen kardoen, bleekselderij en knolvenkel telen’).

Part A

National Assessment - The Netherlands

Luna Sensation Registration Report – Central Zone/Inter zones

of 118


Date: July 2018

Product uses applied for

Field

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination / purpose of crop)

F

G

or

I

Pests or Group of

pests controlled

(additionally:

developmental stages

of the pest or pest

group)

Application Application rate PHI

(days)

Remarks:

e.g. g

safener/synergist

per ha

Method

/ Kind

Timing

/

Growth

stage of

crop &

season

Max.

number

(min.

interval

between

applications)

a) per use

b) per crop/

season

kg, L

product /

ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

kg as/ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

Water

L/ha

min /

max

CEU Witloof Chicory (roots)

CICIF

F Sclerotinia spp.

SCLESP Spraying BBCH

40-49

a) 1

b) 1

a) 0.6 L/ha

b) 0.6 L/ha

a) FLU

:150 +

TFS: 150

b) FLU

:150 +

TFS: 150

150 -

400

21

Label product:

0.6L/ha

Netherlands Witloof Chicory (roots)

CICIF

F Sclerotinia species

SCLESP Spraying BBCH

40-49

May-

Nov

a)1

b)1

a) 0.6 L/ha

b) 0.6 L/ha

a) FLU

:150 +

TFS: 150

b) FLU

:150 +

TFS: 150

150 -

400

21

Label product:

0.6L/ha

Minor use

N= not

Acceptable

CEU Cane fruit (blackberry, common dewberry, raspberry)

RUBFR,RUBCA,RUBLO, RUBID,RUBPH

F Botryotinia

fuckeliana/Botrytis

cinerea BOTRCI

Didymella applanata

DIDYAP

Phragmidium rubi-

idaei

Spraying

BBCH

40-69

a) 2

(21days)

b) 2 (21

days)

a) 0.6 L/ha

b) 1.2 L/ha

a) FLU:

150 + TFS:

150

b) FLU:

300 + TFS:

300

200-

1200

3 Label rate:

0.6 L/ha

Part A


Luna Sensation Registration Report – Central zone? Inter

zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-

No.

Member

state(s)

Crop and/

or situation


F

G

or

I

Pests or Group of

pests controlled

(additionally:


of the pest or pest

group)


(days)

Remarks:

e.g. g

safener/synergist

per ha

Method

/ Kind

Timing

/

Growth

stage of

crop &

season

Max.

number

(min.

interval

between

applications)

a) per use

b) per crop/

season

kg, L

product /

ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

kg as/ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

Water

L/ha

min /

max

PHRARU

Podosphaera aphanis

PODOAP

Netherlands Blackberry and raspberry family (Rubus spp.)

(blackberry, raspberry, common dewberry)

RUBFR,RUBCA,RUBLO, RUBID,RUBPH

F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Didymella applanata

DIDYAP

Spraying

BBCH

40-69

Apr-

Oct

a) 2

(21days)

b) 2 (21

days)

a) 0.6 L/ha

b) 1.2 L/ha

a) FLU:

150 + TFS:

150

b) FLU:

300 + TFS:

300

200-

1200

3

Label rate:

0.6 L/ha

Minor use

Acceptable

under article

51

CEU Berries (blueberry, small cranberry, currant –red, black and

white, gooseberry, mulberry, rosehip, kiwiberry, elderberry)

VACCO,VACMY,VACVI,VACOX,VACMA,RIBRU,RIBNI,

RIBUC, MORSS, ROSSS, ATIAR, SAMSS, ABOSS,

HIORH

F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sphaerotheca mors-

uvae

SPHRMU

Drepanopeziza ribis

f. sp. Ni DREPRN

Drepanopeziza ribis

f. sp. grossulariae

DREPRG

Cronartium ribicola

CRONRI

Spraying

BBCH

13-89

a) 2 (14

days)

b) 2 (

14days)

a) 0.6 L/ha

b) 1.2 L/ha

a) FLU:

150 + TFS:

150

b) FLU:

300 + TFS:

300

200-

1500

7 Label rate:

0.6 L/ha

Netherlands Berries without the kiwiberry F Botryotinia

fuckeliana/Botrytis BBCH a) 2 a) 0.6 L/ha a) FLU: 200- 7 Label rate: Acceptable

under article

Part A



zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-

No.

Member

state(s)

Crop and/

or situation


F

G

or

I

Pests or Group of

pests controlled

(additionally:


of the pest or pest

group)


(days)

Remarks:

e.g. g

safener/synergist

per ha

Method

/ Kind

Timing

/

Growth

stage of

crop &

season

Max.

number

(min.

interval

between

applications)

a) per use

b) per crop/

season

kg, L

product /

ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

kg as/ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

Water

L/ha

min /

max

cinerea

(BOTRCI)Cronartium

ribicola

CRONRI

Drepanopeziza ribis f.

sp. Ni

DREPRI

Sphaerotheca

morsuvae

SPHRMU

Spraying 15-89

Apr-

Oct

(14days)

b) 2

(14days)

b) 1.2 L/ha

150 + TFS:

150

b) FLU:

300 + TFS:

300

1200 0.6 L/ha

Minor use

51

CEU Sea lavender

LIIVU

Rocket

ERUVE

lamb’s lettuce

VLLLO

Garden cress

LEPSA

F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

sclerotiorum.

SCLESC

Spraying

BBCH

13-19

1

1

a) 0.8 L/ha

b) 0.8 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

7

Label rate:

0.8 L/ha

Netherlands Sea lavender

LIIVU

Rocket

ERUVE

F Botrytis

fuckeliana/Botrytis

cinerea

(BOTRCI)Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

13-19

13-40

March -

October

1

1

a) 0.8 L/ha

b) 0.8 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

200 + TFS:

200-

800

7

Label rate:

0.8 L/ha

Minor use

A=Acceptable

under article

51

Part A



zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-

No.

Member

state(s)

Crop and/

or situation


F

G

or

I

Pests or Group of

pests controlled

(additionally:


of the pest or pest

group)


(days)

Remarks:

e.g. g

safener/synergist

per ha

Method

/ Kind

Timing

/

Growth

stage of

crop &

season

Max.

number

(min.

interval

between

applications)

a) per use

b) per crop/

season

kg, L

product /

ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

kg as/ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

Water

L/ha

min /

max

lamb’s lettuce

VLLO

garden cress

LEPSA

200

CEU Endive

CICEN

F Botrytis

fuckeliana/Botrytis

cinerea

(BOTRCI)Sclerotinia

sclerotiorum

SCLESC

Spraying

BBCH

13-19

March -

October

1

1

a) 0.8 L/ha

b) 0.8 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

200 + TFS:

200

200-

800

7 Label rate:

0.8 L/ha

Netherlands Endive

CICEN

F Botrytis

fuckeliana/Botrytis

cinerea

BOTRCISclerotinia

sclerotiorum

SCLESC

Spraying

BBCH

13-19

March -

October

1

1

a) 0.8 L/ha

b) 0.8 L/ha

a) FLU 200

+ TFS: 200

b) FLU:

200 + TFS:

200

200-

800

7

Label rate:

0.8 L/ha

Minor use

A=Acceptable

under article

51

CEU Beans with pod F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

59-79

a) 2 (14

days)

b) 2

(14days)

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

14

Label rate:

0.8 L/ha

Part A



zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-

No.

Member

state(s)

Crop and/

or situation


F

G

or

I

Pests or Group of

pests controlled

(additionally:


of the pest or pest

group)


(days)

Remarks:

e.g. g

safener/synergist

per ha

Method

/ Kind

Timing

/

Growth

stage of

crop &

season

Max.

number

(min.

interval

between

applications)

a) per use

b) per crop/

season

kg, L

product /

ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

kg as/ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

Water

L/ha

min /

max

Netherlands Beans with pod F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

59-79

May-

Oct

a) 2

(14days)

b) 2 (14

days)

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

14 Label rate:

0.8 L/ha

Minor use

A=Acceptable

under article

51

CEU Beans without pod F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

59-79

a) 2

(14days)

b) 2

(14days)

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

14

Label rate:

0.8 L/ha

Netherlands Beans without pod F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

59-79

May-

Oct.

a) 2

(14days)

b) 2

(14days)

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

14 Label rate:

0.8 L/ha

Minor use

A=Acceptable

under article

51

CEU Peas with pod

F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

Spraying BBCH

59-79

a) 2

(14days)

b) 2

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

200-

800

14

Label rate:

0.8 L/ha

Part A



zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-

No.

Member

state(s)

Crop and/

or situation


F

G

or

I

Pests or Group of

pests controlled

(additionally:


of the pest or pest

group)


(days)

Remarks:

e.g. g

safener/synergist

per ha

Method

/ Kind

Timing

/

Growth

stage of

crop &

season

Max.

number

(min.

interval

between

applications)

a) per use

b) per crop/

season

kg, L

product /

ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

kg as/ha

a) max.

rate per

appl.

b) max.

total rate

per

crop/season

Water

L/ha

min /

max

sclerotiorum

SCLESC

(14days) 400 + TFS:

400

Netherlands Peas with pod

F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

59-79

May-

Oct

a) 2

(14days)

b) 2

(14days)

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

14

Label rate:

0.8 L/ha

Minor use

A=Acceptable

under article

51

CEU Pea without pod F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCISclerotinia

sclerotiorum

SCLESC

Spraying BBCH

59-79

a) 2

(14days)

b) 2

(14days)

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

14

Label rate:

0.8 L/ha

Netherlands Pea without pod F Botryotinia

fuckeliana/Botrytis

cinerea

BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

59-79

May-

Oct

a) 2

(14days)

b) 2

(14days)

a) 0.8 L/ha

b) 1.6 L/ha

a) FLU:

200 + TFS:

200

b) FLU:

400 + TFS:

400

200-

800

14

Label rate:

0.8 L/ha

Minor use

A=Acceptable

under article

51

Column 15: zRMS conclusion.

Part A



zones of 118


Date: July 2018

A Acceptable

R Acceptable with further restriction

C To be confirmed by cMS

N Not acceptable / evaluation not possible

n.r. Not relevant for section 3

Protected

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-No.

Member state(s)

Crop and/ or situation (crop destination / purpose of crop)

F G or I

Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group)

Application Application rate PHI (days)

Remarks: e.g. g safener/synergist per ha

Method / Kind

Timing / Growth stage of crop & season

Max. number (min. interval between applications)

a) per use

b) per crop/ season

g, L product / ha

a) max. rate per appl.

b) max. total rate per crop/season

g as/ha



Water L/ha min / max

EU Cane fruit (blackberrys,

common dewberry,

raspberry)

RUBFR,RUBCA,RUBLO,

RUBID,RUBPH

G Botrytis

cinerea/Botryotinia

fuckeliana

BOTRCI

Didymella applanata

DIDYAP

Phragmidium rubi-

idaei

PHRARU

Podosphaera

Spraying BBCH

13 - 89

a) 2 (7

days)

b) 2 (7

days)

a) 0.8

L/ha

b) 1.6

L/ha

a) FLU: 200

+ TFS: 200

b) FLU: 400

+ TFS: 400

200-1500 3 Label rate:

0.6-0.8 L/ha

Part A



zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-No.

Member state(s)


F G or I




Method / Kind



a) per use

b) per crop/ season

g, L product / ha



g as/ha




macularis

SPHRMA

Colletotrichum sp.

COLLSP

Netherlands Blackberry and raspberry

family (Rubus spp.)

(blackberry, raspberry,

common dewberry)

RUBFR,RUBCA,RUBLO,

RUBID,RUBPH

G Botrytis

cinerea/Botryotinia

fuckeliana

BOTRCI

Didymella applanata

DIDYAP

Spraying

BBCH

15-89

Jan-Dec

a) 2

(7days)

b) 2

(7days)

a) 0.8

L/ha

b) 1.6

L/ha

a) FLU: 200

+ TFS: 200

b) FLU: 400

+ TFS: 400

200-1200

3

Label rate:

0.6-0.8 L/ha

Minor use

Acceptable

under

article 51

EU Berries (includes currant

(red, white and black),

gooseberry, blueberries,

small cranberry, mulberry,

rosehips, kiwiberry and

elderberry

G Botrytis

cinerea/Botryotinia

fuckeliana BOTRCI

Podosphaera

macularis

SPHRMA

Colletotrichum sp.

COLLSP

Sphaerotheca mors-

uvae

Spraying

BBCH

13 - 89

a) 2 (7

days)

b) 2 ( 7

days)

a) 0.8

L/ha

b) 1.6

L/ha

a) FLU: 200

+ TFS: 200

b) FLU: 400

+ TFS: 400


0.6-0. 8 L/ha

Part A



zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-No.

Member state(s)


F G or I




Method / Kind



a) per use

b) per crop/ season

g, L product / ha



g as/ha




SPHRMU

Drepanopeziza ribis

DREPRI

Cronartium ribicola

CRONRI

Netherlands Berries (currant),

gooseberry, blueberries,

small cranberry, mulberry,

rosehips, kiwiberry and

elderberry

G Botrytis

cinerea/Botryotinia

fuckeliana

BOTRCI

Cronartium ribicola

CRONRI

Drepanopeziza ribis f.

sp. Ni

DREPRI

Sphaerotheca mors-

uvae

SPHRMU

Spraying

BBCH

15-89

Jan-Dec

a) 2

(7days)

b) 2

(7days)

a) 0.8

L/ha

b) 1.6

L/ha

a) FLU: 200

+ TFS: 200

b) FLU: 400

+ TFS: 400


0.6-0.8 L/ha

Minor use

Acceptable

under

article 51

EU Lettuce (Lactuca spp.),

Baby leaf crops,

Sea lavender rocket

lamb’s lettuce

garden cress

G Botrytis

cinerea/Botryotinia

fuckeliana BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Sclerotinia minor

Spraying

BBCH

40-49

a) 2 (7

days)

b) 2 (7

days)

a) 0.8

L/ha

b) 1.6

L/ha

a) FLU: 200

+ TFS: 200

b) FLU: 400

+ TFS: 400


0.6-0.8 L/ha

Part A



zones of 118


Date: July 2018

1 2 3 4 5 6 7 8 10 11 12 13 14 15

Use-No.

Member state(s)


F G or I




Method / Kind



a) per use

b) per crop/ season

g, L product / ha



g as/ha




SCLEMI

Netherlands sea lavender

LIIVU

Rocket

ERUVE

lamb’s lettuce

VLLLO

garden cress

G Botrytis

cinerea/Botrytis

fuckeliana,

BOTRCI

Sclerotinia

sclerotiorum

SCLESC

Spraying BBCH

12-49

Jan - Dec

a) 2

(7days)

b) 2

(7days)

a) 0.8

L/ha

b) 1.6

L/ha

a) FLU: 200

+ TFS: 200

b) FLU: 400

+ TFS: 400


0.8 L/ha

Acceptable

under

article 51

Column 15: zRMS conclusion.

A Acceptable

R Acceptable with further restriction

C To be confirmed by cMS

Part A



zones of 118


Date: July 2018

N Not acceptable / evaluation not possible

n.r. Not relevant for section 3

Part A


Luna Sensation Registration Report – Central zone/ Inter

zones of 118


Date: February 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 product Luna Sensation is an aqueous suspension concentrate containing 250

g/L fluopyram and 250 g/L trifloxystrobin. All studies have been performed in accordance with the

current requirements and the results are deemed to be acceptable.

Its appearance is that of a light beige suspension with a slightly pungent odour. It is not explosive and has

no oxidizing properties. It has a flash point > 100°C and a self-ignition temperature of 370 °C. The pH

of the neat formulation and a 1% dilution at room temperature is 6.8. The kinematic viscosity at 40˚C is

62 mm2/s with a hydrocarbon content of <<10%. The surface tension of the neat formulation is 38 mN/m

at 25˚C and therefore the preparation should be regarded as being a surface active material. The relative

density of the formulation is between 1.163 – 1.172. Its stability tested at low, ambient and elevated

temperatures allows storage under practical and commercial conditions in HDPE. Therefore, a 2 year

shelf-life of the formulation at ambient temperature in HDPE is granted. Its technical properties indicate

that no particular problems have to be expected, when it is used as recommended.

The technical characteristics of the product are acceptable for an aqueous suspension concentrate.

Implications for labelling: The formulation does not need to be classified in relation to its physico-

chemical properties.

Compliance with FAO specifications: There is no FAO specification for fluopyram yet.

Compatibility of mixtures: No tank mixes are recommended on the label and thus no tests have been

performed.

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 to & compatibility with the contents of the packaging, have been submitted, evaluated and is

considered to be acceptable.

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

required protective clothing and equipment for the safe handling of Luna Sensation has been provided and

is considered to be acceptable.

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

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

Analytical methods for the determination of the active substances fluoyram and trifloxystrobin, relevance

of CIPAC methods and the relevant impurities in the Plant Protection Product Luna Sensation were not

evaluated as part of the EU review of the active substances, therefore all relevant data are provided in this

dossier and are considered adequate.

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

All analytical methods for active substance data and were provided for the EU review of fluopyram and

trifloxystrobin and were considered adequate.

Part A



zones of 118


Date: July 2018

In addition, analytical methods are provided for the determination of trifloxystrobin and its metabolite

CGA321113 in matrices of plant and animal origin, soil and surface water in support of the evaluation

and found to be acceptable.

The analytical method for the determination of fluopyram in surface water is compliant with Dutch

national requirements (LOQ ≤ 0.1µg/L for fluopyram).

The analytical method for the determination of trifloxystrobin and its metabolite CGA321113 in surface

water is compliant with Dutch national requirements (LOQ ≤ 0.1µg/L for trifloxystrobin and its

metabolite CGA321113).

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 Fluopyram + Trifloxystrobin SC 500 (250+250 g/L) were not evaluated as part

of the EU review of fluopyram or trifloxystrobin. Therefore, all relevant data were provided and are

considered adequate.

Study/Parameter Species (sex) Results

Acute oral / LD50 (mg/kg) Rat (F) LD50 cut off = 2000

mg/kg bw

Acute dermal / LD50

(mg/kg) Rat (M & F) LD50 > 2000 mg/kg bw

Acute inhalation in

rats/LC50 (mg/L) Rat (M & F) LC50 > 1.742 mg/L

Acute skin irritation Rabbit (F) Not irritant

Acute eye irritation Rabbit (F) Not irritant

Skin sensitization test,

LLNA in mice Mouse (F) Not sensitising

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

Operator exposure to Fluopyram + Trifloxystrobin SC 500 (250+250 g/L) was not evaluated as part of the

EU review of fluopyram nor trifloxystrobin. Therefore all relevant data and risk assessments have been

provided and are considered to be adequate.

Operator exposure was assessed against the AOEL agreed for the EU review of fluopyram (0.05 mg/kg

bw/day) and, for trifloxystrobin (0.06 mg/kg bw/day).

Data on dermal absorption of Fluopyram + Trifloxystrobin SC 500 was provided and considered

acceptable.

Operator exposure to FLU + TFS SC 500 during the intended spray applications in the field and in

greenhouses was assessed according to the Dutch requirements.

The results of the calculations reveal that the situation regarding operator exposure is favourable for the

intended use of FLU+TFS SC 500.

Part A



zones of 118


Date: July 2018

Tractor mounted application

During high crop spraying, predicted systemic operator exposure without PPE accounts for 104% of the

systemic fluopyram AOEL (0.05 mg/kg bw/day) and 14% of the systemic trifloxystrobin AOEL

(0.06 mg/kg bw/day). When in addition to the normal work clothing gloves are worn during

mixing/loading and when handling contaminated surfaces during application the systemic exposure

accounts for 80% and 10% of the respective AOELs.

Operator exposure during application to low crops is 11% and 3% of the AOELs of fluopyram and

trifloxystrobin AOEL without PPE.

Hand held application

During high crop spraying, predicted systemic operator exposure without PPE accounts for 230% of the

systemic fluopyram AOEL (0.05 mg/kg bw/day) and 33% of the systemic trifloxystrobin AOEL

(0.06 mg/kg bw/day). When in addition normal work clothing and gloves are worn during mixing/loading

and when handling contaminated surfaces during application the systemic exposure accounts for 52% and

11% of the respective AOELs.

Operator exposure during application to low crops is 242% and 32% of the AOELs of fluopyram and

trifloxystrobin AOEL without PPE and 48% and 9% of the respective AOEL when in addition to normal

work clothing gloves are worn during mixing/loading and application.

Application in greenhouse

During low and high crop spraying, predicted systemic operator exposure accounts for 86% of the

systemic fluopyram AOEL and 14% of the systemic trifloxystrobin AOEL even if no PPE is considered..

Potential combined toxicity

Potential combined toxicity is assessed considering the tier one approach, i.e. no unacceptable risk is to be

expected if the sum of AOEL exhaustions (% of AOEL) is <100%.

The sum of the AOEL exhaustions of the protected operator amounts to max. 90% during mechanical

application to low and high crops provided that appropriate PPE are worn. For handheld applications the

combined exposure was found to be max. 63% provided that appropriate PPE are worn. Hence, no further

considerations are necessary.

For greenhouse applications the combined exposure to fluopyram and trifloxystrobin was found to be

equal to 100% of the AOEL without the use of PPE. Correct use of PPE will reduce the dermal exposure

and results in a sufficient reduction of the combined exposure to fluopyram and trifloxystrobin.

Based on these favourable exposure estimates there is no unacceptable risk anticipated for the operator

with the intended use of FLU+TFS SC 500 if adequate work clothing is worn and, in addition, protective

gloves during mixing/loading and application.

Part A



zones of 118


Date: July 2018

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

Bystander exposure to Fluopyram + Trifloxystrobin SC 500 (250+250 g/L) was not evaluated as part of

the EU review of fluopyram nor trifloxystrobin. Therefore, all relevant data and risk assessments have

been provided and are considered adequate.

Field applications

Bystander exposure following field application is calculated with the EUROPOEM II model, the German

model and the UK model. Resident exposure resulting from application of FLU+TFS SC 500 in the field

is estimated using the approach of Martin, S. et al. 1 ( 2008) and the UK model on the evaluation of

bystander/resident exposure. Bystander exposure occurs mainly due to direct drift whereas resident

exposure is considered likely due to vapour after application. In addition, the possible dermal and oral

exposure of a “residential child” is estimated. In short, based on the exposure estimates made there is no

unacceptable risk anticipated for bystanders and residents exposed to FLU + TFS SC 500 via spray drift

or spray deposits.

Greenhouse applications

During spraying operations there should be no bystanders present in greenhouses. Thus, exposure to

bystanders from the intended greenhouse use of FLU+TFS SC 500 is therefore regarded to be not

relevant. Following the national requirements of the Netherlands the Resident Lee Side Turbulence model

(Lijwervel model) should be used to assess the risk of residents living nearby greenhouses.

According to the Resident Lee Side Turbulence model resident exposure after greenhouse application is

negligible for both substances.

Potential combined toxicity

Potential combined toxicity is assessed considering the tier one approach, i.e. no unacceptable risk is to be

expected if the sum of AOEL exhaustions (% of AOEL) is <100%.

The sum of the AOEL exhaustions of the bystanders and residents amounts to max. 15%. Hence, no

further considerations are necessary.

Based on these exposure estimates there is no unacceptable risk anticipated for bystanders or residents

when being exposed to FLU+TFS SC 500.

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

Worker exposure to Fluopyram + Trifloxystrobin SC 500 (250+250 g/L) was not evaluated as part of the

EU review of fluopyram nor trifloxystrobin.

The proposed use is as a fungicide on berries and vegetables. All these crops require re-entry activities

like harvesting or pruning.

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

1 Martin, S., Westphal, D., Erdtmann-Vourliotis, M., Dechet, F., Schulze-Rosario, C., Stauber, F., Wicke, H. and Chester, G. (2008), Guidance for Exosure and Risk Evaluation for Bystanders and Residents exposed to Plant Protection Products during and after Application, J. Verbr. Lebensm. 3, 272-281

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It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work

clothing (but no PPE), when re-entering crops treated with Fluopyram + Trifloxystrobin SC 500

(250+250 g/L). This conclusion is also valid for the simultaneous exposure to fluopyram and

trifloxystrobin.

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

The registration of Fluopyram + Trifloxystrobin SC 500 in Europe is intended for the outdoor use in/on

the crops of cane fruit and small fruits and berries, lettuce, lamb’s lettuce, cresses and other sprouts and

shoots -garden cress, land cress-, brassicea-red mustard, sea lavender- rocket, chicory witloof (protection

of roots in field), scarole (broad leaved endive), beans with and without pods, peas with and without pods

and for the indoor the use in/on cane fruit (raspberries, blackberries and dewberries), small fruits and

berries, lettuce, lamb’s lettuce, cresses and other sprouts and shoots of brassica, garden cress, land cress,

red mustard, sea aster=sea lavender, rocket. The product is a suspension concentrate containing the active

substances fluopyram (AE C656948) and trifloxystrobin at 250 g/L each. For this purpose, supervised

trials were presented in this dossier.

Annex II dossiers have been submitted for both active substances. In chapter IIA 6 of the AII dossier, data

are presented on all relevant aspects of the residue behaviour of the substances.

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

Fluopyram

The stability of fluopyram and its benzamide metabolite (M25) in plant matrices under storage conditions

prior to analysis was assessed during the peer review under Directive 91/414/EEC (EFSA, 2013).

Additional studies have been provided which were assessed in a previous EFSA reasoned opinion (EFSA,

2014). Based on the available data, it was concluded that residues of fluopyram and its metabolite M25

(fluopyram-benzamide) are stable for at least 3 years in high water (lettuce, cabbage), high starch (wheat),

high protein (dry pea), high oil (rapeseeds) and high acid matrices (orange), when stored frozen at ≤-

18°C. Additional storage stability studies were submitted by the applicant to cover stability of residues in

plant matrices at temperatures above -18°C, which could happen during transport. The time periods of

demonstrated storage stability are longer than the periods over which the samples from the field trials

presented in this dossier were stored before analysis.

Supervised residue trial data on outdoor cane fruit were produced in open field (without cover) and in

field under cover (umbrella or partial plastic cover). As a partial cover does not prevent the crop from the

weather conditions the use under cover/ plastic umbrella is considered outdoor use. Overall seven residue

values on raspberries are available supporting the outdoor GAP in northern Europe and allowing

extrapolation to the group of cane-fruit. The MRL of 3 mg/kg for fluopyram in cane fruit is supported by

all available data considered outdoors.

Four residue trials compliant with the intended indoor GAP on raspberry were done in the greenhouse

with the formulation Fluopyram + Trifloxystrobin SC 500. The number of trials is sufficient to support

the indoor use on raspberries. Extrapolation is possible to blackberries. To allow extrapolation to the

whole group of cane fruits 6 trials are needed according to SANCO 7525/VI/95, Rev. 10.3, 13 June 2017.

Since only 4 greenhouse trials are available, the applicant changed the requested authorization to

raspberry and blackberry only. The MRL of 3.0 mg/kg for fluopyram in cane fruits covers the intended

indoor use on raspberry and blackberry.

Supervised residue trial data on outdoor currants were produced in open field (without cover) and in field

under cover (umbrella or partial plastic cover). The outdoor cGAP is supported in northern Europe by 11

independent trials on currants in field (not covered) and 2 trials on currants in field “under cover”. The

MRL of 3 mg/kg for fluopyram in of other small fruits & berries is supported by all available data

considered outdoors.

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Six residue trials on currants were done according to the intended indoor GAP in the greenhouse with the

formulated product containing Fluopyram 250g/L and Trifloxystrobin 250g/L. The trials were conducted

according to the intended indoor GAP in the greenhouse. The number of trials is sufficient to support the

proposed GAP. Extrapolation to the whole group of other small fruits and berries is possible. The MRL of

3.0 mg/kg for fluopyram for the whole group of other small fruits and berries covers the intended use.

It is noted that the indoor and outdoor use on kiwiberries cannot be authorised based on the data

submitted in this dossier, since kiwiberries are extrapolated from grapes and MRLs of grapes apply to

kiwiberries/dwarf kiwi from 1-1-2017.

A sufficient number of outdoor trials in/on lettuce is available to confirm that the outdoor use in NEU and

SEU is less critical than the indoor use. The MRL of 15 mg/kg for fluopyram in “lettuces and salad

plants” is considered to cover the outdoor use on lamb’s lettuce, cresses and other sprouts and shoots -

garden cress, land cress-, brassicea-red mustard, and sea lavender rocket. The request submitted also

includes sea lavender- rocket. Sea lavender belongs to purslanes for which an MRL of 20.0 mg/kg

applies. The use in sea lavender is covered by the current MRL.

A sufficient number of residue values on open leaf lettuce varieties is available to support the proposed

indoor GAP for lettuce, lamb’s lettuce, cresses and other sprouts and shoots -garden cress, land cress-,

brassicea-red mustard, sea lavender- rocket and to derive MRL and risk assessment values. The MRL of

15 mg/kg for fluopyram in “lettuces and salad plants” is supported by all data available considered

indoors. The MRL of 20 mg/kg for fluopyram in purslanes covers the intended indoor use in sea lavender.

Scarole (broad-leaf endive) is a minor crop. A sufficient number of trials covering the proposed outdoor

GAP is available. Considering the number of applications and the application rate, the trials are overdosed

with respect to the proposed GAP. The data submitted show that no exceedance of the current MRL of 15

mg/kg for trifloxystrobin as laid down in Reg. (EU) 396/2005 will occur. Since the trials demonstrate

compliance with the current MRL and an acceptable consumer risk, these overdosed trials are acceptable

to support an authorization for the intended use on scarole.

A sufficient number of trials covering the proposed outdoor GAP on chicory witloof (protection of roots

in field) is available. The trials involve an additional treatment of the roots by dipping prior to storage,

resulted in a more critical residue situation with respect to the intended outdoor GAP. Since the trials

demonstrate compliance with the current MRL and an acceptable consumer risk, this more critical data is

acceptable to support an authorization for the intended outdoor use on witloof chicory.

Beans with pods are a major crop in northern Europe. A sufficient number of trials is available to support

the outdoor use on beans with pods. Although some of the residue values were obtained from more

critical trials, the data show that no exceedance of the current MRL of 1 mg/kg for fluopyram as laid

down in Reg. (EU) 396/2005 will occur.

Beans without pods are a minor crop in northern Europe. A sufficient number of trials on beans and peas

without pods is available to support the outdoor use on beans without pods. The data submitted show that

no exceedance of the current MRL of 0.2 mg/kg for fluopyram as laid down in Reg. (EU) 396/2005 will

occur.

Peas with pods are a minor crop in northern Europe. A sufficient number of trials is available to support

the use on peas with pods. The data submitted show that no exceedance of the current MRL of 1.5 mg/kg

for fluopyram as laid down in Reg. (EU) 396/2005 will occur.

Peas without pods are a major crop in northern Europe. A sufficient number of trials is available to

support the use on peas without pods. The data submitted show that no exceedance of the current MRL of

0.2 mg/kg for fluopyram as laid down in Reg. (EU) 396/2005 will occur.

The GAPs under consideration in this application do not include feed items relevant for the EU animal

diets. They do not result in an increase in the animal burden that would request changes in the current

MRLs set for animal in the EU legislation.

The occurrence of fluopyram residues in rotational crops was investigated in the framework of the peer

review. Fluopyram is a highly persistent compound and residues of fluopyram are expected to be present

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in rotational crops. Several limited field rotational studies were realized, that show that no residues uptake

from rotation is expected in small fruit (strawberries), fruiting vegetables (tomato), legume-vegetables

(peas) cereal grains or in oilseeds. Cereal grains did not show residues from uptake as rotational crop

contrary to the green parts. Uptake can be seen only in maize green parts, spinach, potato and leek. These

cases have been taken into account for the MRLs setting in Europe (rotational MRLs are set for spinach

and similar, for potato, onions, sugar beet and for herbal infusions from flower &leaves). However, no

proposal was made for stem vegetables. For cardoons, celeries, Florence fennels and “other stem

vegetables” MRLs were reduced to 0.01* mg/kg. Consequently, cardoons, celeries, Florence fennels and

crops belonging to the category “other stem vegetables” cannot be allowed as succeeding crops. The

applicant proposed the following restriction:

“In verband met residuen in volggewassen in het eerstvolgende teeltseizoen geen kardoen, bleekselderij,

knolvenkel, zeekool en zeekraal telen.” Zeekool en zeekraal (Samphires) are listed under the stem

vegetables in the DTG list (Definition list scope of permitted use), but according to the residue regulation

they fall under the MRLs for purslane. Residues in samphires grown as succeeding crops are sufficiently

covered by the current MRLs for fluopyram and trifloxystrobin in purslanes and do not need a plant back

restriction. The restriction should therefore read as follows:

“In verband met residuen in volggewassen in het eerstvolgende teeltseizoen geen kardoen, bleekselderij

en knolvenkel telen.”

Trifloxystrobin

Consideration of the storage stability data evaluated for the renewal of trifloxystrobin and that previously

considered in the DAR indicates that trifloxystrobin and its isomers / metabolites are stable in high water

content, high oil content, high protein content, high starch content and high acid content commodities,

under freezer storage conditions for up to 24 months. The time periods of demonstrated storage stability

are longer than the periods over which the samples from the field trials presented in this dossier were

stored before analysis.

The cGAP for outdoor cane fruit is supported by 6 supervised residue trials on raspberries in field “under

cover”. The data submitted show that no exceedance of the current MRL of 3 mg/kg for trifloxystrobin as

laid down in Reg. (EU) 396/2005 will occur.

The cGAP for indoor cane fruit is supported by 4 supervised residue trials on raspberries in field in the

greenhouse. The number of trials is sufficient to support the indoor use on raspberries. Extrapolation is

possible to blackberries. The MRL of 3.0 mg/kg for trifloxystrobin in cane fruits covers the intended

indoor use on raspberry and blackberry. To allow extrapolation to the whole group of cane fruits 6 trials

are needed according to SANCO 7525/VI/95, Rev. 10.3, 13 June 2017. To support the use on the whole

group of cane fruits, 2 additional trials compliant with the intended indoor GAP are still needed.

A total of 6 residue values on currants covering outdoor use in northern Europe is available, allowing

extrapolation to the group of other small fruits & berries. A group MRL of 3.0 mg/kg is in force for the

group ‘other small fruits and berries’ which covers the intended outdoor use in other small fruits &

berries.

A total of 6 residue trials conducted on indoor currants (plastic greenhouse) in 2014 and 2015 were

submitted by the applicant in the context of an application to modify the MRL for trifloxystrobin in

various crops. The studies are included by ZRMS in the context of this registration of Fluopyram &

Trifloxystrobin SC 500. The trials were conducted according to the intended indoor GAP in the

greenhouse with the formulated product containing Fluopyram 250g/L and Trifloxystrobin 250g/L. The

number of trials is sufficient to support the proposed GAP. Extrapolation to the whole group of other

small fruits and berries is possible. The MRL of 3.0 mg/kg for trifloxystrobin for the whole group of other

small fruits and berries covers the intended use.

It is noted that the use on kiwiberries cannot be authourised based on the data submitted in this dossier,

since kiwiberries are extrapolated from grapes and MRLs of grapes apply to kiwiberries/dwarf kiwi from

1-1-2017.

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The combined data on lettuce and scarole provides a sufficient number of trials covering the proposed

outdoor GAP on other salad plants except scarole. The data submitted show that no exceedance of the

current MRL of 15 mg/kg for trifloxystrobin as laid down in Reg. (EU) 396/2005 will occur in lettuce.

The GAP includes lamb’s lettuce, cresses and other sprouts and shoots -garden cress, land cress-,

brassicea-red mustard, and sea lavender rocket which are covered by the group MRL for ‘lettuce and

other salad plant’ and purslanes, respectively.

Ten trials compliant with the proposed indoor GAP on lettuce and other salad plants except scarole were

provided, of which seven trials were performed on open leaf lettuce. The number of trials is sufficient to

derive MRL and risk assessment values for trifloxystrobin on lettuce and the MRL of 15 mg/kg covers the

use on lettuce. To support the proposed GAP on lamb’s lettuce, cresses and other sprouts and shoots -

garden cress, land cress-, brassicea-red mustard, sea lavender- rocket, 8 trials on open leaf varieties are

required, while only 7 trials on open varieties compliant with the proposed GAP are available. Since there

is no clear distinction between open and close leaf varieties, the number of trials is considered sufficient

and the entire indoor dataset is taken to derive MRL and risk assessment values for the whole group

lettuces and salad plants and for purslanes. Lamb’s lettuce, cresses and other sprouts and shoots -garden

cress, land cress-, brassicea-red mustard belong to the group lettuces and salad plants; sea lavender

belongs to the group purslanes. These indoor uses are covered by the existing MRLs of 15 mg/kg.

The combined data on lettuce and scarole provides a sufficient number of trials covering the proposed

outdoor GAP on scarole. The data submitted show that no exceedance of the current MRL of 15 mg/kg

for trifloxystrobin as laid down in Reg. (EU) 396/2005 will occur.

A sufficient number of trials covering the proposed outdoor GAP on chicory witloof (protection of roots

in field) is available. The trials involve an additional treatment of the roots by dipping prior to storage,

resulted in a more critical residue situation with respect to the intended outdoor GAP. Since the trials

demonstrate compliance with the current MRL and an acceptable consumer risk, this more critical data is

acceptable to support an authorization for the intended outdoor use on witloof chicory.

Beans with pods are a major crop in northern Europe. A sufficient number of trials is available to support

the use on beans with pods. The data submitted show that no exceedance of the current MRL of 1 mg/kg

for trifloxystrobin as laid down in Reg. (EU) 396/2005 will occur.

Beans without pods are a minor crop in northern Europe. A sufficient number of trials on beans and peas

without pods are available to support the use on beans without pods. The data submitted show that an

exceedance of the current MRL of 0.09 mg/kg for trifloxystrobin as currently laid down in Reg. (EU)

396/2005 is not expected.

Peas with pods are a minor crop in northern Europe. A sufficient number of trials on beans with pods is

available that can be extrapolated to peas with pods to derive MRL and risk assessment values. An

exceedance of the MRL the current MRL of 1.5 mg/kg for trifloxystrobin as laid down in Reg. (EU)

396/2005 is not expected.

Peas without pods are a major crop in northern Europe. A sufficient number of trials on beans and peas

without pods are available to derive MRL and risk assessment values for peas without pods. An

exceedance of the MRL of 0.09 mg/kg for trifloxystrobin as laid down in Reg. (EU) 396/2005 is not

expected.

Supplementary studies on industrial processing and/or household preparation are submitted on grapes and

strawberries. These additional data was also submitted for the purpose of renewal of approval of

trifloxystrobin. The studies have been evaluated in the Draft (Renewal) Assessment Report prepared

according to the Commission Regulation (EU) N° 1107/2009 (version June 2017) by RMS United

Kingdom. Based on the studies additional conversion factors for risk assessment for grapes/pomace,

strawberry/washed, strawberry/preserve and strawberry/jam are confirmed by RMS United Kingdom.

Supplementary studies on industrial processing and/or household preparation are submitted on beans with

pod. Based on the studies additional conversion factors for risk assessment were derived for bean with

pod/washed bean and bean with pod/cooked bean.

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The GAPs under consideration in this application do not include feed items relevant for the EU animal

diets. They do not result in an increase in the animal burden that would request changes in the current

MRLs set for animal in the EU legislation.

Based on the rotational confined crop study, considering that the application rate of trifloxystrobin within

the EU ranges between 0.1-1.3 kg a.s. /ha and that trifloxystrobin was applied to a bare soil (interception

of trifloxystrobin by the plants is expected in practice), it can be concluded that trifloxystrobin residue

levels in rotational commodities are not expected to exceed 0.01 mg/kg.

Conclusions

Based on the assessment of the residues section the outdoor use of Fluopyram + Trifloxystrobin SC 500

in the Central Zone can be authorised in/on the crops of the groups ‘cane fruits’ and ‘other small fruits

and berries’, lettuce, scarole (broad leaved endive), lamb’s lettuce, cresses and other sprouts and shoots -

garden cress, land cress-, brassicea-red mustard, sea lavender-rocket, beans with and without pods, peas

with and without pods, and chicory witloof (protection of roots in field).

The indoor use of Fluopyram + Trifloxystrobin SC 500 in Europe can be authorised in/on lettuce,

raspberry and blackberry, whole group of other small fruit & berries, lamb’s lettuce, cresses and other

sprouts and shoots -garden cress, land cress-, brassicea-red mustard, sea lavender- rocket.

To support the indoor use of Fluopyram + Trifloxystrobin SC 500 on cane fruits, 6 indoor trials with

fluopyram and trifloxystrobin on raspberries and/or blackberries are required. To allow extrapolation

from raspberry to blackberry 4 trials are needed, while 6 trials are needed to allow extrapolation to the

whole group of cane fruits (SANCO 7525/VI/95, Rev. 10.3, 13 June 2017). Since 4 greenhouse trials are

available, only extrapolation to blackberries is possible. The applicant therefore changed the requested

authorization for indoor use to raspberry and blackberry only.

The use on kiwiberries cannot be authourised based on the data submitted in this dossier, since

kiwiberries are extrapolated from grapes and MRLs of grapes apply to kiwiberries/dwarf kiwi from 1-1-

2017. Residue data on grapes or kiwiberries are required to support the proposed outdoor and indoor uses

on kiwiberries.

Cardoons, celeries, Florence fennels and crops belonging to the category “other stem vegetables” can not

be allowed as succeeding crops. Therefore, a label restriction is required to prevent these crops from

being grown in rotation.

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

Fluopyram:

A long-term consumer intake concern was not identified for any of the European diets incorporated in the

EFSA PRIMo. The highest calculated chronic intake accounted for 58% of the ADI (DE child). None of

the acute dietary exposures was found to exceed the ARfD. The highest NESTIs of fluopyram residues

were estimated at 54% and 22% of ARfD for lettuce, for children and adults/general population,

respectively. It is concluded that the agricultural uses of fluopyram for the uses described in the current

dossier do not cause any unacceptable health risks to consumers.

Trifloxystrobin

No chronic consumer intake concerns were identified for any of the European diets. The highest chronic

exposure was calculated for WHO Cluster diet B, representing 6.2% of the ADI. The contribution of

residues in the crops under consideration to the total consumer exposure was low, accounting for a

maximum of 0.6 % of the ADI (FR all population) on other lettuce and other salad. As trifloxystrobin is

not acutely toxic, no Acute Reference Dose (ARfD) was set. Therefore, no calculation of the NESTI

(National Estimate of Short-Term Intake) was performed. It is concluded that the agricultural uses of

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trifloxystrobin for the uses described in the current dossier do not cause any unacceptable health risks to

consumers.

Based on the different calculations made to estimate the risk for consumer though diet and other means it

can be concluded that the use of product Fluopyram + Trifloxystrobin SC 500 (250+250 g/L) does not

lead to unacceptable risk for consumer when applied according to the recommendations.

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

Appropriate endpoints were used to calculate PECs for Fluopyram + Trifloxystrobin SC 500 (250+250

g/L), fluopyram in soil, surface water, groundwater and air, and for AE C656948-7-hydroxy in ground

water, for the intended use patterns.

Appropriate endpoints from the EU review were used to calculate PECs for Fluopyram + Trifloxystrobin

SC 500, trifloxystrobin in soil, surface water, ground water and air; for CGA 321113and CGA 373466 in

soil and surface water, CGA321113, CGA373466, NOA413161 and NOA413163 in groundwater, for the

intended use patterns.

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

9.4 and 9.5)

The PECs of fluopyram, trifloxystrobin and relevant metabolites in soil were estimated using a simple

first tier approach (Excel sheet), crop interception data were taken from the FOCUS groundwater

guidance paper (FOCUS 2002) and the DT50 values established in the EU review were used.

The results for PEC soil for the active substances and major metabolites were used for the eco-

toxicological risk assessment.

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

Section 5, Point 9.6)

The PECgw of fluopyram and its metabolite AE C656948 7-hydroxy and trifloxystrobin and its

metabolites CGA321113, CGA373466, NOA413161 and NOA413163

were calculated using the simulation model FOCUS PEARL (version 4.4.4) model with the

Kremsmünster scenario. PECgw were evaluated as the 80th percentile of the mean annual leachate

concentration at 1 m soil depth.

The PEARL Kremsmünster assessment shows that fluopyram and its metabolite will not be found in

groundwater at concentrations greater than 0.1 μg/L and also not above 0.01 µg/L, except for the field use

in berries and the greenhouse use in berries, cane fruit and lamb’s lettuce, land cress and rocket (early

applications).

Due to the exceedance of the national threshold value of 0.01 µg/L, a higher tier assessment PECgw was

carried out with GeoPEARL 3.3.3 for the active substance fluopyram and its metabolite fluopyram-7-

hydroxy after use on soft fruits (berries and cane fruit).

Results show that for this use a restriction sentence is not required.

However for several other uses including greenhouse uses also concentrations above 0.01 µg/L are

predicted. No higher tier calculations have been submitted. Hence a restriction sentence is required to

protect groundwater abstraction areas, or a higher tier assessment should be performed.

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The PEARL Kremsmünster assessment shows trifloxystrobin will not be found in groundwater at

concentrations greater than 0.1μg/L or 0.01 µg/L.

For the metabolites CGA321113, CGA373466, NOA413161 and NOA413163 the PECGW were found in

groundwater at concentrations greater than 0.1 μg/L.

A non-relevance assessment was carried out (refer to Part B Section 8) and it was concluded that these

metabolites are non-relevant with regard to human toxicity, ecotoxicity and pesticidal activity.

Therefore, there are no concerns for groundwater from the use of trifloxystrobin and its metabolites in

accordance with the use pattern for the current formulation.

Based on a refined assessmentusing the model GEM, the use of Fluopyram + Trifloxystrobin SC 500 is

not expected to lead to leaching into groundwater at levels that would be unacceptable when applied

according to the recommended use pattern.

Monitoring data groundwater

Fluopyram

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

groundwater.

Trifloxystrobin

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

metabolites in groundwater.

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

5, Points 9.7 and 9.8)

The PEC of fluopyram, trifloxystrobin and its metabolites (CGA321113 and CGA373466) in surface

water (PECsw and PECsed) has been assessed using TOXSWA 1.2..

The aquatic exposure via spray drift entry was estimated for the Dutch standard scenario with TOXSWA

1.2.

Greenhouse uses

The potential entry into the water body is calculated assuming an emission of 0.1 %

The results for PEC surface water for the active substances and metabolites were used for the aquatic risk

assessments.

Field uses

For the upwards and sideways application in soft fruit, drift mitigation has been taken into account next to

the default drift values. For field uses (downward spraying) no drift mitigation was requested.

The results for PEC surface water for the active substances and metabolites were used for the aquatic risk

assessments.

Monitoring data surface water

Fluopyram

There are no data available in the Pesticide Atlas regarding the presence of the substance fluopyram in

surface water.

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Trifloxystrobin

The active substance trifloxystrobin was observed in the surface water (most recent data from 2015). In

the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 1.6

µg/L (02-05-2014).

The relevant EQS for this substance are the AA-EQS and MAC-EQS and equal 0.27 and 0.81 µg/L

respectively (11-11-2013).

As there is only one exceedance of thresholds, this cannot be correlated to any land use and the

monitoring data have no consequences for the proposed uses of the product.

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

9.9)

No experimental studies were performed since no requirements are currently specified and exposure is

expected to be negligible due to the low vapour pressure of both active substances.

Fluopyram: the vapour pressure (1.2 × 10-6 Pa extrapolated for 20 °C) and the calculated Henry’s

constant (2.98 × 10-5 Pa m3 mol-1 in water at pH 7 and 20°C) do not trigger volatility studies under

laboratory conditions.

Based on the short half-life time in air, there is no potential for fluopyram for a long-range transport or

accumulation in the atmosphere. Furthermore, only limited quantities of fluopyram will enter the

atmosphere, due to the low vapour pressure of the substance.

Trifloxystrobin: due to the low vapour pressure of 3.4 × 10-6 Pa at 25 °C, significant volatilisation of

trifloxystrobin from soil, water or plant surfaces is not to be expected. In addition, degradation of

trifloxystrobin in air by OH-radicals was calculated to proceed with a DT50 value of 18 to 24 hours

(Atkinson calculated). Therefore, it is not expected that trifloxystrobin would be present in air for

extended time periods or be transported over long distances or even accumulate in the air.

Implications for labelling resulting from environmental fate assessment: There are no specific

implications for labelling resulting from environmental assessment.

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

Fluopyram + Trifloxystrobin SC 500 (250+250 g/L) was not the representative formulation for the

inclusion of fluopyram nor trifloxystrobin into Annex I. The appropriate risk assessments have been

provided for The Netherlands and are considered adequate.

For fluopyram, in addition to new risk assessment parameters, which are now considered in the

assessment of risk to birds and aquatic organisms, the EU review concluded that at national registration

Member States must pay particular attention to the risk to birds and aquatic organisms. Conditions of use

shall include risk mitigation measures where appropriate.

This data has been reviewed and the resulting risk assessments are considered adequate.

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

The risk assessment for terrestrial vertebrates was conducted according to the Guidance Document on

Risk Assessment for Birds & Mammals, EFSA 2009 for Tier 1 worst case scenarios.

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No risk assessment was performed as an exposure of birds and mammals to fluopyram and trifloxystrobin

residues is not to be anticipated due to the intended use of Fluopyram & Trifloxystrobin SC 500 as spray

application in greenhouses.

Birds

For birds, the acute risk assessment for luna sensation indicated an acceptable risk. Based on GAP

adaptations and additional refined risk assessments for long term an acceptable risk for all uses is

demonstrated.

Terrestrial vertebrates (other than birds)

For mammals, the acute risk assessment for luna sensation indicated an acceptable risk. With the accepted

refinements the TER values for the small herbivorous mammals (vole) for all proposed uses are still

below the trigger of 5 for all applications, for the remaining generic focal species the trigger was

exceeded.

Based on GAP adaptations and additional refined risk assessments acceptable risk for all uses except

chicory witloof (roots) has been demonstrated.

The assessment of the effects of exposure via drinking water and secondary poisoning indicated

acceptable risk for birds and mammals.

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

The acute and long-term risk to fish is considered acceptable for all uses except for fruit crops for both

a.s., combination toxicity and metabolites. The acute risk for trifloxystrobin was refined based on a HC5

whereas the long-term risk refinement was not accepted. However, because of the new activity decree

(effective since January 1st 2018) where the baseline drift is 0.5% (75% drift reduction) the long-term risk

for fish is considered acceptable for the field uses. The acute and long-term risk for fruit crops was

addressed through mitigation measures (DRT95).

The acute and long-term risk to invertebrates is considered acceptable for all uses except for fruit crops

for both a.s., combination toxicity and metabolites. The risk for trifloxystrobin was refined based on an

ERO-RAC. The remaining risk for the field uses was covered by the new activity decree (baseline drift of

0.5%). The acute and long-term risk for fruit crops was addressed through mitigation measures (DRT95).

The long-term risk to sediment-dwelling invertebrates is considered acceptable for all uses for both a.s.,

combination toxicity and metabolites.

The long-term risk to algae is considered acceptable for all uses for both a.s., combination toxicity and

metabolites.

The assessment for the product is covered by the risk assessment of the active substances (see Core

assessment).

The long-term risk to aquatic plants is considered acceptable for all uses.

The following has to be stated on the label:

Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van zij- of

opwaarts bespoten bessen en braam- en framboosachtigen op percelen die grenzen aan oppervlaktewater

uitsluitend toegestaan indien op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste

de klasse DRT95.

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

10.5)

Bees

The hazard quotients for contact exposure are below the trigger of concern (QHC < 50). Therefore no

unacceptable risk to bees from contact exposure is expected using the product according to the proposed

use pattern.

Other non-target arthropods

The HQin-field value is lower than the trigger of 2 for Tier 1 (according to ESCORT 2) for both indicator

species indicating an acceptable risk for these species. For the in-field assessment for field uses, reference

is made to the conclusion presented in the core document. Considering the outcome of the risk assessment

according to laboratory and extended laboratory studies, the overall off-field risk to non-target

arhthropods can be considered as acceptable for field applications. For greenhouse uses, the following

warning phrase needs to be included in on the label:

Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg deskundigen (uw leverancier

van natuurlijke vijanden, de producent van dit middel, uw adviseur) over het gebruik van dit middel in

combinatie met het gebruik van natuurlijke vijanden.

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

10.6)

Earthworms

The risk assessment for the formulation Fluopyram + Trifloxystrobin SC 500 and earthworms indicated

an acceptable risk.

Effects on other soil non-target macro-organisms

The risk assessment for the formulation Fluopyram + Trifloxystrobin SC 500 and Hypoaspis aculeifer

and Folsomia candida indicated an acceptable risk.

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

The risk of fluopyram to organic matter decomposition was evaluated by a soil litter degradation study

with formulation Fluopyram SC 500 (500 g/L). From the results of this study it can be concluded that soil

residues of fluopyram to be anticipated after long-term use (plateau concentration) plus spray application

of Fluopyram SC 500 (annual application rate) resulting to a measured soil concentration of 0.514 mg

a.s./kg soil have no influence on organic matter breakdown. For trifloxystrobin, a study on organic matter

breakdown is not required based on the DT90 and on acceptable TER values for earthworms and other soil

macro-organisms.

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

In no case, deviations from the control exceeded 25% after 28 days, indicating low risk to soil micro-

organisms.

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

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

Terrestrial non-target plants

The risk assessment indicates that no unacceptable adverse effects on non-target plants are to be expected

following the use of the product according to the proposed use pattern in field crops, vegetables and bush

and cane fruits (berries).

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)

All the data regarding the efficacy of the product have been submitted. These data demonstrate that

Fluopyram + Trifloxystrobin SC 500 (250+250 g/L) fulfils all criteria for the authorization of

preparations described in Directive 97/57/EC (Uniform Principles, Annex VI to Directive 91/414/EEC).

No phytotoxicity, effects on neighboring or following crops were observed.

In NL Luna Sensation is authorized for use in strawberry (unprotected) against Botrytis cinerea

(BOTCRI) and Sphaerotheca macularis (SCLESC) at 0.8 L/ha. The use in lettuce (protected and

unprotected) against Sclerotinia spp., Botryotinia fuckeliana/ Botrytis cinerea is authorized at 0.8 L/ha.

Data for lettuce were assessed in a previous assessment and were concluded to provide insufficient

amount of supporting trials. Presently lettuce is on the NL-label as a minor use under article 51 for which

no efficacy or crop safety needs to be shown.

This application concerns the extension of use on Chicory Witloof (roots), Cane fruit (blackberries,

dewberries, raspberries), other small fruit & berries (blueberries, cranberries, currants-red, black and

white), endive, watercress + sea lavender + rocket, lamb’s lettuce + Land cress, beans with pod, beans

without pod, peas with pod and peas without pod grown in the field/outdoors. The crops mentioned are

all minor uses or minor crops in NL. For the Netherlands the extension of uses are claimed under article

51 for which no efficacy nor crop-safety needs to be shown.

3.2 Conclusions

The use on kiwiberries cannot be authourised based on the data submitted in this dossier, since

kiwiberries are extrapolated from grapes and MRLs of grapes apply to kiwiberries/dwarf kiwi from 1-1-

2017. Residue data on grapes or kiwiberries are required to support the proposed outdoor and indoor uses

on kiwiberries.

The MRL for trifloxystrobin in cane fruits covers the intended indoor use on raspberry and blackberry.

For extrapolation to the whole group of cane fruits more trials are needed.

The use on chicory witloof (roots) cannot be authorized based on a risk for mammals.

For all other uses applied for an authorisation can be granted.

The following restriction/warning sentences should be placed on the label:

Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van zij- of

opwaarts bespoten bessen en braam- en framboosachtigen op percelen die grenzen aan oppervlaktewater

uitsluitend toegestaan indien op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste

de klasse DRT95.

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In verband met residuen in volggewassen in het eerstvolgende teeltseizoen geen kardoen, bleekselderij en

knolvenkel telen.

3.3 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation

None.

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Appendix 1 – Copy of the product authorisation

Refer to the covering letter

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Appendix 2 – Copy of the product label

Wettelijk Gebruiksvoorschrift Het middel is uitsluitend toegelaten als schimmelbestrijdingsmiddel voor het professionele gebruik door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.1 Ctgb juni 2015) onder de hierna vermelde toepassingsvoorwaarden. Toepassingsvoorwaarden:

Toepassingsgebied Werkzaamheid getoetst op

Dosering* middel per toepassing

Maximaal aantal toepassingen per 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen

Aardbei (onbedekte teelt)

Vruchtrot1, echte meeldauw2

0,8 l/ha 2 7 1 (24 uur)

Bloembol- en bloemknolgewassen (onbedekte teelt)

Vuur3 0,3 l/ha 5 7 -

* 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 Vruchtrot (Botrytis cinerea); 2 Echte meeldauw (Sphaerotheca macularis); 3 Vuur (Botrytis spp.) Het gebruik in de teelt van druif, sla en pioen is beoordeeld conform de “vereenvoudigde uitbreidingsprocedure”. Er is voor deze toepassing/en geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in dit/deze toepassingsgebied/en valt onder verantwoordelijkheid van de gebruiker. Het gebruik in de teelt van bessen, braam- en framboosachtigen, andijvie, tuinkers, waterkers, veldsla, rucola, lamsoor en peulgroenten knolselderij, asperge, bloembollen en bloemknollen (Sclerotiënrot), bolbloemen, bloemenzaadteelt, bloemisterijgewassen, boomkwekerijgewassen (m.u.v. van de opkweek van druif), vaste planten en veredelingsteelt en basiszaadproductie van kruiden (m.u.v. kruidenzaadgewassen) en veredelingsteelt en basiszaadproductie sierteeltgewassen (m.u.v. boomkwekerijgewassen) is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassing/en geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom

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aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in dit/deze toepassingsgebied/en valt onder verantwoordelijkheid van de gebruiker.

Toepassingsgebied Werkzaamheid aannemelijk tegen





Bessen m.u.v. kiwibes (onbedekte teelt)

Grauwe schimmel5, bessenroest14, bladvalziekte15, echte meeldauw16

0,6 l/ha 2 14 7

Bessen m.u.v. kiwibes (bedekte teelt)

Grauwe schimmel5, bessenroest14, bladvalziekte15, echte meeldauw16

0,6-0,8 l/ha 2 7 7

Druif (onbedekte teelt)

Echte meeldauw6, roodvuur7 0,2 l/ha 2 14 14

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

Grauwe schimmel5, twijgsterfte17 0,6 l/ha 2 21 3

Braam Framboos (bedekte teelt)

Grauwe schimmel5, twijgsterfte17 0,6-0,8 l/ha 2 7 3

Sla (Lactuca spp.) (onbedekte teelt)

Sclerotiënrot4, grauwe schimmel5

0,8 l/ha 1 - 7

Sla (Lactuca spp.) (bedekte teelt)


0,8 l/ha 2 7 7

Andijvie (onbedekte teelt)


0,8 l/ha 1 - 7

Tuinkers (onbedekte teelt)


0,8 l/ha 1 - 7

Tuinkers (bedekte teelt)


0,8 l/ha 2 7 7

Veldsla Sclerotiënrot4, grauwe 0,8 l/ha 1 - 7

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(onbedekte teelt) schimmel5

Veldsla (bedekte teelt)


0,8 l/ha 2 7 7

Rucola (onbedekte teelt)


0,8 l/ha 1 - 7

Rucola (bedekte teelt)


0,8 l/ha 2 7 7

Lamsoor (onbedekte teelt)


0,8 l/ha 1 - 7

Lamsoor (bedekte teelt)


0,8 l/ha 2 7 7

Boon met peul (onbedekte teelt)


0,8 l/ha 2 14 14

Boon zonder peul (onbedekte teelt)


0,8 l/ha 2 14 14

Erwt met peul (onbedekte teelt)


0,8 l/ha 2 14 14

Erwt zonder peul (onbedekte teelt)


0,8 l/ha 2 14 14

Knolselderij (onbedekte teelt)

Sclerotiënrot4,

Bladvlekkenziekte15 0,5 l/ha 2 14 14

Asperge (onbedekte teelt)


0,8 l/ha 1 - -

Pioen (onbedekte teelt)


0,8 l/ha 1 - -

Pioen (bedekte teelt)


0,8 l/ha 2 7 -

Bloembollen en Sclerotiënrot4 0,8 l/ha 1 - -

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bloemknollen m.u.v. tulp en lelie (onbedekte teelt)

Bolbloemen (bedekte teelt)


0,8 l/ha 2 7 -

Bloemisterijgewassen (onbedekte teelt)

Sclerotiënrot4, grauwe schimmel8; echte meeldauw9,10,11,12

0,8 l/ha 1 - -

Boomkwekerijgewassen, m.u.v. de opkweek van druif (bedekte teelt)

Grauwe schimmel8, echte meeldauw9,10,11,12

0,8 l/ha 2 7 -

Vaste planten (onbedekte teelt)

Sclerotiënrot4, grauwe schimmel8, echte meeldauw9,10,11,12

0,8 l/ha 1 - -

Vaste planten (bedekte teelt)

Sclerotiënrot4, grauwe schimmel8; echte meeldauw9,10,11,12

0,8 l/ha 2 7 -

Bloemenzaadteelt (onbedekte teelt)


0,8 l/ha 1 - -

Veredelingsteelt en basiszaadproductie van kruiden m.u.v. kruidenzaadgewassen (onbedekte teelt)

Sclerotiënrot4, grauwe schimmel8, echte meeldauw11,12

0,8 l/ha 1 - -

Veredelingsteelt en basiszaadproductie van sierteeltgewassen m.u.v. boomkwekerijgewassen (onbedekte teelt)

Sclerotiënrot4, grauwe schimmel8; echte meeldauw11,12

0,8 l/ha 1 - -

Veredelingsteelt en Sclerotiënrot4, grauwe 0,8 l/ha 2 7 -

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basiszaadproductie van kruiden m.u.v. kruidenzaadgewassen (bedekte teelt)

schimmel8, echte meeldauw11,12

Veredelingsteelt en basiszaadproductie van sierteeltgewassen m.u.v. boomkwekerijgewassen (bedekte teelt)

Sclerotiënrot4, grauwe schimmel8, echte meeldauw11,12

0,8 l/ha 2 7 -

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. 4 Sclerotiënrot (Sclerotinia spp.) 5 Grauwe schimmel (Botryotinia fuckeliana/ Botrytis cinerea) 6 Echte meeldauw (Erysiphe necator) 7 Roodvuur (Pseudopeziza tracheiphila) 8 Grauwe schimmel (Botrytis spp.) 9 Echte meeldauw (Podosphaera spp.) 10 Echte meeldauw (Microsphaera spp.) 11 Echte meeldauw (Erysiphe spp.) 12 Echte meeldauw (Oidium spp.) 13 Bladvlekkenziekte (Septoria apiicola) 14 Bessenroest (Cronartium ribicola)

15 Bladvalziekte (Drepanopeziza ribis) 16 Echte meeldauw (Sphaerotheca mors-uvae)

17 Twijgsterfte (Didymella applanata) Overige toepassingsvoorwaarden Toepassing in de teelt van druif is uitsluitend toegestaan tot BBCH 73 (tot de druiven zo groot zijn als grutten en de trossen beginnen te hangen).

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In de teelt van knolselderij toepassen vanaf BBCH 40 (verdikking van de vegetatieve delen). In de onbedekte teelt van braam- en framboosachtigen toepassen van BBCH 40 tot en met BBCH 69 (vanaf de ontwikkeling van de bloemknoppen tot einde bloei). In de onbedekte teelt van bloembol- en bloemknolgewassen maximaal 1,5 L/ha middel per 12 maanden toepassen. Toepassing in de onbedekte teelt van bloembol- en bloemknolgewassen, met uitzondering van lelie, is uitsluitend toegestaan van maart tot en met augustus; de toepassing in lelie is toegestaan van maart tot en met oktober. Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden in de volgende teelten: • de onbedekte teelt van knolselderij • de onbedekte teelt van asperge • de onbedekte teelt van bloemisterijgewassen • de onbedekte teelt van bloembol- en bloemknolgewassen m.u.v. lelie* • de onbedekte bloemenzaadteelt • de bedekte teelt van sla • de bedekte teelt van boomkwekerijgewassen m.u.v. de opkweek van druif • de bedekte teelt van bolbloemen • de bedekte teelt van pioen • de bedekte en onbedekte teelt van vaste planten • de bedekte en onbedekte veredelingsteelt en basiszaadproductie van kruiden m.u.v. kruidenzaadgewassen • de bedekte en onbedekte veredelingsteelt en basiszaadproductie van sierteeltgewassen m.u.v. boomkwekerijgewassen *Om het grondwater te beschermen mag dit product in de onbedekte teelt van lelie niet worden gebruikt in grondwaterbeschermingsgebieden in de periode van 1 september tot 1 maart. Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van zij- of opwaarts bespoten bessen en braam- en framboosachtigen op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste de klasse DRT95. 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. In verband met residuen in volggewassen in het eerstvolgende teeltseizoen geen kardoen, bleekselderij en knolvenkel telen.

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Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden in bloembol- en bloemknolgewassen en de verschillen in gewasverdraagzaamheid, verdient het aanbeveling om alvorens het middel toe te passen een proefbespuiting uit te voeren. Op enkele tulpen zijn bloeireacties in de vorm van een lichte bloemverkleuring waargenomen. Het gebruik op tulpen vlak voor of tijdens de bloei wordt derhalve ontraden. Resistentiemangement Dit middel bevat de werkzame stoffen fluopyram en trifloxystrobin. Fluopyram behoort tot de pyridinyl-ethyl-benzamiden. De Frac code is 7. Trifloxystrobin hoort tot de strobilurinen. De Frac code is 11. 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.

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Appendix 3 – Letter of Access

Fluopyram is a new active substance. Bayer CropScience is the owner of all the studies, there is no need

for any Letters of Access. However, a letter of access of Bayer CropScience AG to bayer CropScience

SA-NV is included in the dossier.

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Appendix 4 – List of data submitted in support of the evaluation

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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

Studies relied on Y/N

Owner

KIIIA 2.1 /01 KIIIA 2.4.2 /01

KIIIA 2.5.1 /01

KIIIA 2.5.2 /01

KIIIA 2.5.3 /01

KIIIA 2.6.1 /01

KIIIA 2.8.2 /01

KIIIA 2.8.3.1 /01

KIIIA 2.8.3.2 /01

KIIIA 2.8.5.2 /01

KIIIA 2.8.6.1 /01

KIIIA 2.8.8.2 /01

2007 Physical, chemical and technical properties of fluopyram + trifloxystrobin SC 500 (250+250) G Bayer CropScience, Report No.: 14 1050 5451, Edition Number: M-291446-01-2 EPA MRID No.: 47567506 Date: 2007-07-16 GLP/GEP: yes, unpublished

Yes Y Y Bayer CropScience

KIIIA 2.2.1 /01 KIIIA 2.2.2 /01

KIIIA 2.3.1 /01

KIIIA 2.3.3 /01

2008 Safety relevant technical properties of fluopyram + trifloxystrobin SC 500 (250 + 250) g/L - Final report - Bayer CropScience, Report No.: FOR0909(PC)01, Edition Number: M-296771-01-2 EPA MRID No.: 47567507 Date: 2008-01-28 GLP/GEP: yes, unpublished


KIIIA 2.7.1 /01 KIIIA 2.7.3 /01

KIIIA 2.7.4 /01

KIIIA 2.7.5 /01

KIIIA 4.1.3 /01

2010 Storage stability and shelf life of fluopyram + trifloxystrobin SC 500 (250+250 g/L) - [Packaging material: HDPE] - Final report Bayer CropScience, Report No.: 2007-000441-01, Edition Number: M-290919-02-1 Date: 2010-01-26 GLP/GEP: no, unpublished


KIIIA 2.8.2 /02 KIIIA 2.8.3.1 /02

2011 Persistent foaming and suspensibility of fluopyram + trifloxystrobin SC 500 (250+250 g/L) - Final report - Bayer CropScience, Report No.: FM0111(RP00)N01, Edition Number: M-413898-01-1 Date: 2011-09-08 GLP/GEP: no, unpublished


KIIIA 4.2.2 /01 2008 Summary and conclusive report of studies on spray tank cleaning realized in the years 2000 - 2008 Bayer CropScience, Report No.: M-357166-01-1, Edition Number: M-357166-01-1 Date: 2008-09-24 Non GLP, unpublished


KIIIA 4.7 /01 2008 Fluopyram - Statement on the pyrolytic behaviour under

Yes Y Y Bayer CropScie

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Owner

controlled conditions and on the controlled incineration as a safe means of disposal - AE C656948 Bayer CropScience, Report No.: AF08/011, Edition Number: M-297296-01-2 Date: 2008-02-06 Non GLP, unpublished

nce

KIIIA 4.7 /02 2008 Trifloxystrobin - Statement on the pyrolytic behaviour under controlled conditions and on the controlled incineration as a safe means of disposal - CGA 279202 / AE C642802 Bayer CropScience, Report No.: AF08/077, Edition Number: M-307173-01-2 Date: 2008-09-15 Non GLP, unpublished









Owner

KIIIA 5.2.2 /01 2007 Determination of fluopyram and trifloxystrobin in formulations assay - GLC, internal standard Bayer CropScience, Report No.: AM009707MF1, Edition Number: M-286825-01-2 Date: 2007-04-16 GLP/GEP: no, unpublished


KIIIA 5.2.2 /02 2007 Validation of GLC-method AM009707MF1 - determination of fluopyram and trifloxystrobin in formulations - Bayer CropScience, Report No.: VB1-AM009707MF1, Edition Number: M-286826-01-2 Date: 2007-04-13 GLP/GEP: no, unpublished


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Owner

KIIIA 5.3.1 /02 KIIIA 5.3.1 /12

2012 Validation of the BCS method no. 01207 (based on modified QuEChERS method) for the determination of selected BCS analytes and their metabolites in carrot, apple, orange, oilseed rape seed and beans Eurofins Agroscience Services Chem GmbH (EAS Chem), Hamburg, Germany Bayer CropScience, Report No.: S10-00279, Edition Number: M-424756-02-1 Date: 2012-02-03 ...Amended: 2013-12-11 GLP/GEP: yes, unpublished


KIIIA 5.3.1 /04 2002 Method 00742 for the determination of residues of trifloxystrobin (parent compound) and CGA 321113 (metabolite) in/on sample materials of carrot, brussels sprouts, cabbage, tomato, red pepper and lettuce by HPLC-MS/MS Bayer AG, Leverkusen, Germany Bayer CropScience, Report No.: 00742, Edition Number: M-060431-01-1 Method Report No.: MR-078/02 Date: 2002-04-24 GLP/GEP: yes, unpublished


KIIIA 5.3.1 /05 2003 Supplement E001 of the method 00742 for the determination of residues of Trifloxystrobin and CGA 321113 in/on the additional sample materials bean, broccoli, cauliflower, cherry, cucumber, currant, leek, melon, plum and strawberry Bayer CropScience, Report No.: 00742/E001, Edition Number: M-089461-01-1 Method Report No.: MR-052/03 Date: 2003-02-19 GLP/GEP: yes, unpublished


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Owner

KIIIA 5.3.1 /06 2004 Method 00839 for the determination of residues of Trifloxystrobin, CGA 31113 and Tebuconazole in/on sample materials of wheat, barley and rye by HPLC-MS/MS Bayer CropScience, Report No.: 00839, Edition Number: M-122162-01-1 Method Report No.: MR-155/03 Date: 2004-02-06 GLP/GEP: yes, unpublished


KIIIA 5.3.1 /07 2004 Supplement E001 of the method 00839 for the determination of residues of Trifloxystrobin, CGA 321113 and tebuconazole in/on the additional sample materials apple, pear, grape, broccoli, kidney bean, cauliflower, pepper, plum, Brussels ... Bayer CropScience, Report No.: 00839/E001, Edition Number: M-084249-01-1 Method Report No.: MR-051/04 Date: 2004-08-02 GLP/GEP: yes, unpublished


KIIIA 5.3.1 /08 2007 Analytical method 01013 for the simultaneous determination of residues of the active Items BYF00587, prothioconazole, tebuconazole, trifloxystrobin and the metabolites BYF00587-desmethyl, JAU6476-desthio (SXX0665) and CGA321113 in/on ... Bayer CropScience, Report No.: 01013, Edition Number: M-283439-03-1 Method Report No.: MR-06/138 Date: 2007-01-25 ...Amended: 2008-02-18 GLP/GEP: yes, unpublished


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Owner

KIIIA 5.3.1 /09 2010 Modification M002 of the residue analytical method 01013 for the determination of trifloxystrobin and CGA 321113 in/on hops cone (green and dried) and processed materials (hops draff, brewers yeast, and beer) by HPLC-MS/MS Bayer CropScience, Report No.: 01013/M002, Edition Number: M-390173-01-1 Method Report No.: MR-10/031 Date: 2010-09-02 GLP/GEP: yes, unpublished


KIIIA 5.3.1 /10 2011 Amendment no. 1 to report no: P 602 11 5501 - Development of the residue analytical method 01313 for the determination of CGA279202, CGA357262, CGA357261, CGA331409, CGA321113, and CGA373466 by HPLC-MS/MS Bayer CropScience, Report No.: 01313, Edition Number: M-411496-02-1 Method Report No.: MR-11/179 Date: 2011-07-26 ...Amended: 2013-07-24 GLP/GEP: yes, unpublished


KIIIA 5.3.1 /11 2013 Modification M001 of the residue analytical method 01313 for the determination of trifloxystrobin (CGA279202) and its metabolites/isomers CGA357261, CGA357262, CGA331409, CGA321113, and CGA373466 in plant sample material at an LOQ of 0.01 mg/kg by HPLC-MS/MS Bayer CropScience, Report No.: 01313/M001, Edition Number: M-448498-01-1 Date: 2013-03-04 GLP/GEP: yes, unpublished


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Owner

KIIIA 5.3.1 /13 2013 Validation of the BCS-method-01300/M005 (based on QuEChERS) for the determination of residues of trifloxystrobin and its metabolite CGA 321113 and of fluoxastrobin (HEC 5725 E-isomer), HEC 5725 Z-isomer and the metabolite HEC 7154 in animal tissues Eurofins Agroscience Services Chem GmbH (EAS Chem), Hamburg, Germany Bayer CropScience, Report No.: 01300/M005, Edition Number: M-453914-02-1 Method Report No.: 01300/M005 Date: 2013-05-08 ...Amended: 2013-06-06 GLP/GEP: yes, unpublished


KIIIA 5.3.1 /14 2013 Independent laboratory validation of the BCS-method-01300/M005 (based on (QuEChERS) for the determination of residues of trifloxystrobin and its metabolite CGA 321113 and of fluoxastrobin (HEC 5725 E-isomer), HEC 5725 Z-isomer and the metabolite HEC 7154 in animal tissues Eurofins Agroscience Services, Chem SAS, Vergèze, France Bayer CropScience, Report No.: S12-02570, Edition Number: M-467489-01-1 Method Report No.: S12-02570 Date: 2013-10-17 GLP/GEP: yes, unpublished


KIIIA 5.4 /01 2014 Analytical method 01401 for the determination of trifloxystrobin in soil by HPLC-MS/MS Bayer CropScience, Report No.: MR-13/139, Edition Number: M-476164-01-1 Method Report No.: MR-13/139 Date: 2014-02-03 GLP/GEP: yes, unpublished


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Owner

KIIIA 5.6 /01 2002 Enforcement method for the determination of trifloxystrobin in drinking and surface water by HPLC-MS/MS Bayer AG, Leverkusen, Germany Bayer CropScience, Report No.: 00714, Edition Number: M-055331-01-1 Method Report No.: MR-414/01 Date: 2002-04-04 GLP/GEP: yes, unpublished







Owner Data protection granted Y/N


KIIIA 7.6.2 /01 2014 In vitro human skin penetration of 14C-fluopyram in the fluopyram and trifloxystrobin SC 500 formulation Eurofins Agroscience Services, Chem SAS, Vergèze, France Bayer CropScience, Report No.: S13-04169, Edition Number: M-475331-01-1 Date: 2014-01-27 GLP/GEP: yes, unpublished

Yes Bayer CropScience

Y Y

KIIIA 7.6.2 /02 2014 [14C]-trifloxystrobin (FLU + TFS SC 500) - In vitro dermal absorption study using human skin Bayer S.A.S., Bayer CropScience, Sophia Antipolis, France Bayer CropScience, Report No.: SA 13189, Edition Number: M-486321-01-1 Date: 2014-05-14 GLP/GEP: yes, unpublished


Y Y

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Metabolism and residues

Part A



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Date: July 2018


Author(s) Year Title Source (where different from



Data protect. claimed Y/N

Data protect. granted Y/N

Study relied On Y/N

Owner

KIIIA 8.1.1 /01

Cavaillé, C.; Meilland-Berthier, I.

2008 Storage stability of residues of AE C656948 and its metabolites (AE F148815, AE C657188, BCS-AA10139 and BCS-AA10065) in plants during deep freeze storage for up to 36 months Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 06-06, Edition Number: M-299461-03-3 EPA MRID No.: 48239911 Date: 2008-03-20 ...Amended: 2008-03-20 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /01

Y Y Y BCS

KIIIA 8.1.1 /02


2009 Storage stability of residues of AE C656948 and its metabolites (AE F148815, AE C657188 and BCS-AA10139) in orange during deep freeze storage for up to 36 months Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 07-02, Edition Number: M-356046-02-2 EPA MRID No.: 48239912 Date: 2009-09-18 ...Amended: 2010-09-09 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /02

Y Y Y BCS

KIIIA 8.1.1 /03


2010 Storage stability of residues of AE C656948 metabolites (AE 1344122 and BCS-AA10065) in dry pea, rape and orange during deep freeze storage for up to 24 months Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: MR-10/045, Edition Number: M-389465-01-2 EPA MRID No.: 48239913 Date: 2010-09-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /03

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.1.1 /04

Schoening, R.; Billian, P.

2010 Storage stability of fosetyl-Al and its metabolite, propamocarb-hydrochloride, fluopyram and its metabolites, tebuconazole, bixafen and its metabolite, prothioconazole-desthio, 1,2,4-triazole and its metabolites, fenhexamid, trifloxystrobin and its metabolite and JAU-6476-hydroxy-desthio compounds in/on plant matrices for 5 days at - 5°C or + 5°C Bayer CropScience, Report No.: MR-10/009, Edition Number: M-388450-02-1 Date: 2010-08-18 ...Amended: 2010-09-28 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /04

Y Y Y BCS

KIIIA 8.1.1 /05

Lakaschus, S.; Gizler, A.

2014 7 Days freezer storage stability study with different combinations of a total of 61 analytes (parent and metabolite molecules) and five matrix types (high water / acidic / starch / protein / oil) Eurofins Agroscience Services Chem GmbH (EAS Chem), Hamburg, Germany Bayer CropScience, Report No.: S13-03307, Edition Number: M-480441-01-1 Date: 2014-03-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /05

Y Y Y BCS

KIIIA 8.1.1 /06

Kissling, M. 1999 Stability of residues of CGA 279202 and its metabolite CGA 321113 in deep freeze stored analytical specimens of grapes, cucumbers, potatoes and wheat (whole plant, grains and straw) Novartis Crop Protection AG, Basel, Switzerland Bayer CropScience, Report No.: 154/96, Edition Number: M-038193-02-1 EPA MRID No.: 44757212 Date: 1999-01-06 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /06

Y Y Y BCS

Part A



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Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.1.1 /07

Grunenwald, M. C.

1999 Stability of CGA-279202 and CGA-321113 in crops and processed fractions under freezer storage conditions Novartis Crop Protection, Inc., Greensboro, NC, USA Bayer CropScience, Report No.: 160-97, Edition Number: M-038204-02-1 EPA MRID No.: 44757214 Date: 1999-01-21 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /07

Y Y Y BCS

KIIIA 8.1.1 /08

Schulte, G.; Diehl, P.

2013 Storage stability of CGA 279202, CGA 357262, CGA 357261, CGA331409, CGA 321113 and CGA 373466 in plant matrices for 24 months Bayer CropScience, Report No.: P642110501, Edition Number: M-468560-01-1 Date: 2013-11-05 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.1.1 /08

Y Y Y BCS

KIIIA 8.3.1.1 /01

Loriau, P. 2012 Residues of fluopyram and trifloxystrobing in raspberry under plastic umbrella at intervals following two foliar applications of FLU+TFS 500 SC - Belgium, season 2011 Redebel S.A., Saint Amand, Belgium Bayer CropScience, Report No.: BCS-G401-11, Edition Number: M-433737-01-1 Date: 2012-02-27 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.1 /06

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.1.1 /02

Oostingh, C. 2012 Amendment no. 1 to report no: PTZ-NLI-11797 - Residues of fluopyram + trifloxystrobin in red raspberry under plastic umbrella at intervals following two foliar applications of fluopyram & trifloxystrobin SC 500 Proeftuin Zwaagdijk, Zwaagdijk, Netherlands Bayer CropScience, Report No.: PTZ-NLI-11797, Edition Number: M-434309-02-1 Date: 2012-06-08 ...Amended: 2013-03-06 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.1 /07

Y Y Y BCS

KIIIA 8.3.1.1 /03

Malet, J. C.; Allard, L.

2012 Mesure du niveau de résidu de fluopyram et de trifloxystrobine, après 2 applications de la préparation F413BCS sur framboisier dans le cadre d'une extension d'usage sur la culture - Residues of fluopyram and trifloxystrobine, after 2 applications of F413BCS in raspberry in support of the registration Ministère de l'Agriculture et de la Pêche, Paris, France Bayer CropScience, Report No.: RAFR03509, Edition Number: M-434818-01-1 Date: 2012-05-07 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.1 /04

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.1.1 /04

Malet, J. C.; Allard, L.

2012 Mesure du niveau de résidu de fluopyram et de trifloxystrobine, après 2 applications de la préparation F413BCS sur framboisier dans le cadre d'une extension d'usage sur la culture - Residues of fluopyram and trifloxystrobine, after 2 applications of F413BCS in raspberry in support of the registration Ministère de l'Agriculture et de la Pêche, Paris, France Bayer CropScience, Report No.: RAFR00810, Edition Number: M-434815-01-1 Date: 2012-06-15 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.1 /05

Y Y Y BCS

KIIIA 8.3.1.1 /05

Perny, A. 2016 Determination of Fluopyram and its metabolite Fluopyram-benzamide and Trifloxystrobin and its metabolite CGA 321113 Residues in Raspberry Following Applications with F413BCS under Greenhouse in Southern Europe in 2015 Study number B5169, Report includes Trial Nos.:

B5169-EF1 B5169-EF2 B5169-EF3 B5169-TL1

Edition Number: M-565909-02-1 Date: 2016-06-30 Amended: 2017-11-22 GLP/GEP: yes, unpublished

Y Y Y DGAL

KIIIA 8.3.2.1 /01

Loriau, P. 2012 Residues of fluopyram and trifloxystrobin in red currant under plastic umbrella at intervals following two foliar applications of FLU+TFS 500 SC - Belgium, season 2011 Redebel S.A., Saint Amand, Belgium Bayer CropScience, Report No.: BCS-G402-11, Edition Number: M-433738-01-1 Date: 2012-03-22 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.2 /03

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.2.1 /02

Oostingh, C. 2012 Amendment no. 1 to report no: PTZ-NLI-11796 - Residues of fluopyram + trifloxystrobin in red currant under plastic umbrella at intervals following two foliar applications of fluopyram & trifloxystrobin SC 500 Proeftuin Zwaagdijk, Zwaagdijk, Netherlands Bayer CropScience, Report No.: PTZ-NLI-11796, Edition Number: M-434301-02-1 Date: 2012-06-08 ...Amended: 2013-03-06 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.2 /04

Y Y Y BCS

KIIIA 8.3.2.1 /03

Szeley, C.;

Effertz, C. 2016 Determination of the residues

of fluopyram and trifloxystrobin in/on red and black currant after spray application of AE C656948 & CGA 279202 SC 500 in the greenhouse in Northern France and Spain Bayer CropScience AG, Monheim, Germany. Report No.: 15-2032, Report includes Trial Nos.: 15-2032-01 15-2032-02 15-2032-03 15-2032-04 Date: 2016-05-04 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.2.1 /04

Bellof, S. 2015 Determination of the residues of fluopyram and trifloxystrobin in/on red and black currant after spray application of fluopyram & trifloxystrobin SC 500 in the greenhouse in Italy Bayer CropScience AG, Monheim, Germany. Bayer CropScience, Report No.: 14-2025, Date: 2015-10-01 ...Amended: 2015-12-02 GLP/GEP: yes, unpublished

Y Y Y BCS

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Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.3.1 /01

Schmeer, K.; Stuke, S.

2008 Determination of the residues of AE C656948 and trifloxystrobin in/on head lettuce and lettuce after spraying of AE C656948 & CGA279202 (500 SC) in the greenhouse in Germany, Netherlands and Southern France Bayer CropScience, Report No.: RA-2620/07, Report includes Trial Nos.: R 2007 0266/3 = 0266 - 07 R 2007 0642/1 = 0642 - 07 R 2007 0644/8 = 0644 - 07 R 2007 0645/6 = 0645 - 07 Edition Number: M-308622-01-1 Date: 2008-10-06 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.3.1 /02

Nuesslein, F. 2003 Determination of residues of trifloxystrobin and CGA 321113 in/on lettuce following spray application of Flint 50 WG in the greenhouse in Southern France, Germany, Italy, Netherlands and Portugal Bayer CropScience, Report No.: RA-2036/02, Report includes Trial Nos.: 0073-02 0171-02 0172-02 0173-02 0174-02 0175-02 0176-02 0177-02 0178-02 R 2002 0073/0 R 2002 0171/0 R 2002 0172/9 R 2002 0173/7 R 2002 0174/5 R 2002 0175/3 R 2002 0176/1 R 2002 0178/8 Edition Number: M-085240-01-1 Date: 2003-03-06 GLP/GEP: yes, unpublished

Y Y Y BCS

Part A



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Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.3.1 /03

Schulte, G.; Diehl, P.

2015 Determination of the residues of fluopyram and trifloxystrobin in/on lettuce after spray application of fluopyram & trifloxystrobin SC 500 in the greenhouse in Germany, the Netherlands, Belgium and France Bayer CropScience, Report No.: 14-2028, Report includes Trial Nos.: 14-2028-01 14-2028-02 14-2028-03 14-2028-04 14-2028-05 14-2028-06 Edition Number: M-534623-01-1 Date: 2015-09-28 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.1 /01

Bacher, R. 2010 Determination of residues of fluopyram and metabolites in currant and raspberry: Minor crop study 2009 PTRL Europe GmbH, Ulm, Germany Bayer CropScience, Report No.: P 1799 G, Edition Number: M-431229-01-1 Date: 2010-04-07 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.2 /01

Y Y Y BCS

KIIIA 8.3.1 /02

Witte, A. 2010 Determination of residues of fluopyram (AE C656948) and its metabolite fluopyram-benzamide (AE F148815) after two applications of formulation BAY 18500 F in berries, 9 field trials in 2010 CIP Chemisches Institut Pforzheim GmbH, Pforzheim, Germany Bayer CropScience, Report No.: 10L03113-01-RABE, Edition Number: M-431227-01-1 Date: 2010-12-28 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.2 /02

Y Y Y BCS

Part A



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Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.1 /03

Bacher, R. 2012 Determination of residues of fluopyram and metabolites and tebuconazole in/on raspberry: Minor crop study 2011 PTRL Europe GmbH, Ulm, Germany Bayer CropScience, Report No.: P 2428 G, Edition Number: M-431230-01-1 Date: 2012-02-20 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.2 /01

Bacher, R. 2010 Determination of residues of fluopyram and metabolites in currant and raspberry: Minor crop study 2009 PTRL Europe GmbH, Ulm, Germany Bayer CropScience, Report No.: P 1799 G, Edition Number: M-431229-01-1 Date: 2010-04-07 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.1 /01

Y Y Y BCS

KIIIA 8.3.2 /02

Witte, A. 2010 Determination of residues of fluopyram (AE C656948) and its metabolite fluopyram-benzamide (AE F148815) after two applications of formulation BAY 18500 F in berries, 9 field trials in 2010 CIP Chemisches Institut Pforzheim GmbH, Pforzheim, Germany Bayer CropScience, Report No.: 10L03113-01-RABE, Edition Number: M-431227-01-1 Date: 2010-12-28 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.1 /02

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.2 /05

Nuesslein, F.; Behn, U.

2004 Determination of residues of trifloxystrobin in/on black currant following spray application of Flint 50 WG in the field in Germany and Great Britain Bayer CropScience, Report No.: RA-2024/03, Report includes Trial Nos.: 0025-03 0104-03 0159-03 0161-03 R 2003 0025/5 R 2003 0104/9 R 2003 0159/6 R 2003 0161/8 Edition Number: M-064994-01-1 Date: 2004-04-14 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.3 /01

Nuesslein, F. 2003 Determination of residues of trifloxystrobin and CGA 321113 in/on lettuce following spray application of Flint 50 WG in the Field in the Netherlands, Germany and Great Britain Bayer CropScience, Report No.: RA-2040/02, Report includes Trial Nos.: 0084-02 0196-02 0197-02 0198-02 R 2002 0084/6 R 2002 0196/6 R 2002 0197/4 R 2002 0198/2 Edition Number: M-083503-01-1 Date: 2003-02-25 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.3 /02

Kissling, M. 2000 Residue study with CGA 279202 in or on cos lettuce in Switzerland Novartis Crop Protection AG, Basel, Switzerland Bayer CropScience, Report No.: 2043/00, Edition Number: M-030185-01-1 Date: 2000-09-07 GLP/GEP: yes, unpublished

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.3 /03

Kissling, M. 2000 Residue study with CGA 279202 in or on endive in Switzerland Novartis Crop Protection AG, Basel, Switzerland Bayer CropScience, Report No.: 2044/00, Edition Number: M-024781-01-1 Date: 2000-09-29 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.4 /02

Y Y Y BCS

KIIIA 8.3.3 /04

Nuesslein, F. 2003 Determination of residues of trifloxystrobin and CGA 321113 in/on lettuce following spray application of flint 50 WG in the field in Germany and Great Britain Bayer CropScience, Report No.: RA-2087/02, Report includes Trial Nos.: 0635-02 0636-02 R 2002 0635/6 R 2002 0636/4 Edition Number: M-103962-01-1 Date: 2003-05-16 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.4 /01

Cavaille, C.; Meilland-Berthier, I.

2012 Determination of the residues of AE C656948 in/on endive (scarole) after spraying of fluopyram SC 500 in the field in the Netherlands, Germany, Belgium and northern France Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 10-2099, Report includes Trial Nos.: 10-2099-01 10-2099-02 10-2099-03 10-2099-04 Edition Number: M-423901-01-1 Date: 2012-01-30 GLP/GEP: yes, unpublished

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.4 /02

Kissling, M. 2000 Residue study with CGA 279202 in or on endive in Switzerland Novartis Crop Protection AG, Basel, Switzerland Bayer CropScience, Report No.: 2044/00, Edition Number: M-024781-01-1 Date: 2000-09-29 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.3.3 /03

Y Y Y BCS

KIIIA 8.3.5 /01

Fargeix, G. 2013 Amendment No.1 - Determination of the residues of AE C656948 and trifloxystrobin in/on chicory, witloof after dip and spraying of fluopyram SC 500 and AE C656948 & CGA279202 SC 500 in the field and room, hall, store, etc. in Germany, Belgium, northern France and the Netherlands Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2140, Report includes Trial Nos.: 11-2140-01 11-2140-02 11-2140-03 11-2140-04 Edition Number: M-448916-02-1 Date: 2013-03-12 ...Amended: 2013-11-18 GLP/GEP: yes, unpublished

Y Y Y BCS

Part A



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Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.6 /01

Noss, G.; Ballmann, C.

2012 Determination of the residues of AE C656948 and trifloxystrobin in/on bean, kidney after spraying of AE C656948 & CGA279202 SC 500 in the field in Germany, Belgium, Spain, Italy, France (south) and Portugal Bayer CropScience, Report No.: 10-2125, Report includes Trial Nos.: 10-2125-01 10-2125-02 10-2125-03 10-2125-04 10-2125-05 10-2125-06 Edition Number: M-425357-01-1 Date: 2012-02-14 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.6 /02

Noss, G.; Guerleyen, N.; Ballmann, C.

2012 Determination of the residues of AE C656948 and trifloxystrobin in/on bean, kidney after spraying of AE C656948 & CGA279202 SC 500 in the field in France (north) Bayer CropScience, Report No.: 10-2128, Report includes Trial Nos.: 10-2128-01 10-2128-02 Edition Number: M-425362-02-1 Date: 2012-02-14 ...Amended: 2012-03-12 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.6 /03

Glaubitz, J. 2013 Determination of the residues of AE C656948 and trifloxystrobin in/on French bean after spray application of AE C656948 & CGA279202 SC 500 in the field in Germany and northern France Bayer CropScience, Report No.: 12-2030, Report includes Trial Nos.: 12-2030-01 12-2030-02 Edition Number: M-467728-01-1 Date: 2013-10-16 GLP/GEP: yes, unpublished

Y Y Y BCS

Part A



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Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.6 /04

Nuesslein, F.; Eberhardt, R.

2003 Determination of residues of trifloxystrobin and CGA 321113 in/on kidney bean following spray application of Flint 50 WG in the field in Northern France, Germany and Great Britain Bayer CropScience, Report No.: RA-2044/02, Report includes Trial Nos.: 0081 - 02 0199 - 02 0200 - 02 0201 - 02 R 2002 0081/1 R 2002 0199/0 R 2002 0200/8 R 2002 0201/6 Edition Number: M-106401-01-1 Date: 2003-06-03 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.3.7 /01

Fargeix, G. 2013 Determination of the residues of fluopyram and trifloxystrobin in/on field pea after spray application of AE C656948 & CGA279202 SC 500 in northern France and Germany Bayer S.A.S., Bayer CropScience, Lyon, France Bayer CropScience, Report No.: 11-2000, Report includes Trial Nos.: 11-2000-01 11-2000-02 Edition Number: M-444960-01-1 Date: 2013-01-21 GLP/GEP: yes, unpublished

Y Y Y BCS

Part A



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Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.3.7 /02

Glaubitz, J.; Ballmann, C.

2014 Determination of the residues of fluopyram and trifloxystrobin in/on field pea after spray application of AE C656948 & CGA279202 SC 500 in the field in Germany, Northern France, Belgium and United Kingdom Bayer CropScience, Report No.: 12-2031, Report includes Trial Nos.: 12-2031-01 12-2031-02 12-2031-03 12-2031-04 12-2031-05 12-2031-06 Edition Number: M-475814-01-1 Date: 2014-01-28 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.5.3 /01

Schmeer, K.; Kuppels, U.

2009 Determination of the residues of AE C656948 and trifloxystrobin in/on grape after spraying and spraying, low-volume of AEC656948 & CGA279202 SC 500 in the field in France (South) and Italy Bayer CropScience, Report No.: 08-2204, Report includes Trial Nos.: 08-2204-02 08-2204-03 Edition Number: M-357708-02-1 Date: 2009-10-14 ...Amended: 2012-06-11 GLP/GEP: yes, unpublished

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.5.3 /02

Schmeer, K.; Hoffmann, M.

2010 Determination of the residues of AE C656948 and trifloxystrobin in/on grape and the processed fractions (must; pomace, grape; wine at bottling and wine at first taste test) after spraying of AE C656948 & CGA279202 SC 500 in the field in France (South) and Italy Bayer CropScience, Report No.: 08-3204, Report includes Trial Nos.: 08-3204-01 08-3204-02 Edition Number: M-384844-01-1 Date: 2010-06-02 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.5.3 /03

Nuesslein, F. 2003 Determination of residues of trifloxystrobin and CGA 321113 in/on strawberry (fruit washed, preserve, washings, jam) following spray application of Flint 50 WG in the field in Northern France and Germany Bayer CropScience, Report No.: RA-3038/02, Report includes Trial Nos.: 0188-02 0191-02 R 2002 0188/5 R 2002 0191/5 Edition Number: M-086063-01-1 Date: 2003-03-06 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.5.3 /01

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.5.3 /04

Freitag, T. 2013 Amendment No. 0001 to Report No.: 12-3012 - Determination of the residues of trifloxystrobin in/on strawberry and the processed fractions (fruit, washed; washings; preserve and jam) after spray application of trifloxystrobin WG 50 in the field in the Netherlands and Germany Bayer CropScience, Report No.: 12-3012, Report includes Trial Nos.: 12-3012-01 12-3012-02 Edition Number: M-464835-02-1 Date: 2013-09-02 ...Amended: 2013-10-10 GLP/GEP: yes, unpublished ...also filed: KIIIA 8.5.3 /02

Y Y Y BCS

KIIIA 8.5.3 /06

Nuesslein, F. 2003 Determination of residues of trifloxystrobin and CGA 321113 in/on climbing French bean and processing products (...) following spray application of Flint 50 WG in the greenhouse in Germany and Italy Bayer CropScience, Report No.: RA-3037/02, Report includes Trial Nos.: 0072 - 02 0181 - 02 R 2002 0072/2 R 2002 0181/8 Edition Number: M-104911-01-1 Date: 2003-05-22 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.6 / 01

Cavaille C., Ratajczak M

2009a

Determination of the residues of AE C656948 in/on tomato after spraying of fluopyram SC 500 in the fields in France (north) and Germany Report n° 08-2165 GLP: yes; unpublished

Y Y Y BCS

KIIIA 8.6 / 02

Cavaille C., Ratajczak M.

2009b

Determination of the residues of AE C656948 in/on tomato after spraying of fluopyram SC 500 in the field in Italy and Spain Report n° 08-2176 GLP: yes; unpublished

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.6 / 03

Ballesteros, C.; Portet, M.

2009a

Determination of the residues of AE C656948 in/on pea after spraying of fluopyram SC 500 in the fields in Germany and Netherlands Report n° 08-2167 GLP: yes; unpublished

Y Y Y BCS

KIIIA 8.6 / 04

Ballesteros, C.; Portet, M.

2009b

Determination of the residues of AE C656948 in/on pea after spraying of fluopyram SC 500 in the field in Italy and Spain Report n° 08-2178 GLP: yes; unpublished

Y Y Y BCS

KIIIA 8.6 / 05

Cavaillé, C.; Ratajczak, M.

2009c

Determination of the residues of AE C656948 in/on strawberry after spraying of fluopyram SC 500 in the field in France (North) and Germany Bayer CropScience S.A., Lyon, France Bayer Report No.: 08-2166 Report includes Trial Nos.: 08-2166-01 08-2166-02 Edition Number: M-357953-01-1 Date: 2009-10-27 GLP/GEP: Yes, unpublished

Y Y Y BCS

KIIIA 8.6 / 06

Cavaillé, C.; Ratajczak, M.

2009d

Determination of the residues of AE C656948 in/on strawberry after spraying of fluopyram SC 500 in the field in Italy and Spain Bayer CropScience S.A., Lyon, France Bayer Report No.: 08-2177 Report includes Trial Nos.: 08-2177-01 08-2177-02 Edition Number: M-357930-01-1 Date: 2009-10-27 GLP/GEP: Yes, unpublished

Y Y Y BCS

Part A



zones of 118


Date: July 2018







Study relied On Y/N

Owner

KIIIA 8.9 /01

Fargeix, G. 2012 Determination of the residues of fluopyram in/on strawberry after spray application of Fluopyram 500SC in Spain and Italy Bayer CropScience, Report No.: 11-2014, Report includes Trial Nos.: 11-2014-01 11-2014-02 Edition Number: M-440055-01-1 Date: 2012-11-30 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.9 /02

Pross, S., Bauer, J., Ruhl, S.

2011 Determination of the residues of AE C656948 and trifloxystrobin in/on strawberry after spray application of AE C656948 & CGA279202 SC 500 in the field in Germany Bayer CropScience, Report No.: 09-2243 Report includes Trial Nos.: 09-2243-01 Edition Number: M-416330-01-1 Date: 2011-10-04 GLP/GEP: yes, unpublished

Y Y Y BCS

KIIIA 8.9 /03

Gabriel, E.J. 2012 Study on the Residue Behaviour of Fluopyram & Trifloxystrobin in/on Strawberry after Treatment with Fluopyram & Trifloxystrobin SC 500 under Field Conditions in Germany, 2010 Bayer CropScience, Report No.: 10-2313 Report includes Trial Nos.: 10-DE-065 Edition Number: M-452478-01-1 Date: 2011-10-04 GLP/GEP: yes, unpublished

Y Y Y BCS

BCS: Bayer CropScience DGAL, Ministère de l’Agriculture, de l’Agroalimentaire et de la Forêt

Fate and Behaviour Core field

Part A



zones of 118


Date: July 2018


Author(s) Year Title Source (where different

from company) Company name, Report No., Date, GLP/GEP status (where



Owner Data protection granted

Study relied on Y/N

KIIIA 9.4 /02

Reinken, G.; Heruth, D.

2014 Predicted environmental concentrations in soil (PECsoil) of trifloxystrobin and metabolites - Use in several arable crops and bushberries in Europe Bayer CropScience, Report No.: EnSa-14-0218,

Edition Number: M-495675-01-1 Date: 2014-01-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.5 /01

No Bayer CropScience

N Y

KIIIA 9.4 /03

Reinken, G.; Bolekhan, A.

2014 Trifloxystrobin (TFS) and metabolites: PECsoil EUR - Use in berries, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-14-1094,



N Y

KIIIA 9.4 /04

Reinken, G.; Kaune, M.

2011 Trifloxystrobin core PECsoil and soil accumulation: Modelling core info document for soil exposure assessment in the EU Bayer CropScience, Report No.: MEF-11/634,



N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.5 /01





N Y

KIIIA 9.5 /02





N Y

KIIIA 9.5 /03





N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.1 /01

Kley, C.; Sittig, S.

2013 Fluopyram (FLU) and metabolite: PECgw FOCUS PEARL, PELMO EUR - Use in cabbage in Europe Bayer CropScience, Report No.: EnSa-13-0745,

Edition Number: M-475881-01-1 Date: 2013-10-22 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2

/01


N Y

KIIIA 9.6.1 /02


2013 Fluopyram (FLU) and metabolite: PECgw FOCUS PEARL, PELMO EUR - Use in field and vegetable beans in Europe Bayer CropScience, Report No.: EnSa-13-0791,


/02


N Y

KIIIA 9.6.1 /03

Kley, C.; Bolekhan, A.

2014 Fluopyram (FLU) and metabolite: PECgw FOCUS PEARL, PELMO EUR - Use in vines and soft fruits in Europe Bayer CropScience, Report No.: EnSa-14-1093,

Edition Number: M-502418-01-1

Date: 2014-10-30 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2

/03


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.1 /04


2014 Fluopyram (FLU) and metabolite: PECgw FOCUS PEARL, PELMO EUR - Use in tobacco in Europe Bayer CropScience, Report No.: EnSa-14-1206,


/04


N Y

KIIIA 9.6.1 /05

Kley, C. 2012 Fluopyram core PECgw Focus EU: Modelling core info for groundwater exposure risk assessment in Europe - Fluopyram (AE C656948, FLU) - Fluopyram-7-hydroxy (BCS-AA10065, M08) Bayer CropScience, Report No.: EnSa-13-0443,


Date: 2012-01-10 ...Amended: 2013-09-13 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2

/05


N Y

KIIIA 9.6.1 /06

Reinken, G.; Kehrein, N.

2016 Trifloxystrobin (TFS) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in cabbage in Europe Bayer CropScience, Report No.: EnSa-16-0095,


/10


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.1 /07


2016 Trifloxystrobin (TFS) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in beans and leafy vegetables in Europe Bayer CropScience, Report No.: EnSa-16-0096,


/11


N Y

KIIIA 9.6.1 /08


2016 Trifloxystrobin (TFS) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in berries, hops, and tobacco in Europe Bayer CropScience, Report No.: EnSa-16-0097,


/12


N Y

KIIIA 9.6.1 /09


2013 Trifloxystrobin core PECgw EU Focus: Modelling core info document for groundwater risk assessment in the EU Bayer CropScience, Report No.: EnSa-13/0094,



/09


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.2 /01




/01


N Y

KIIIA 9.6.2 /02


2013 Fluopyram (FLU) and metabolite: PECgw FOCUS PEARL, PELMO EUR - Use in field and vegetable beans in Europe Bayer CropScience, Report No.: EnSa-13-0791,


/02


N Y

KIIIA 9.6.2 /03





/03


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.2 /04


2014 Fluopyram (FLU) and metabolite: PECgw FOCUS PEARL, PELMO EUR - Use in tobacco in Europe Bayer CropScience, Report No.: EnSa-14-1206,


/04


N Y

KIIIA 9.6.2 /05



Date: 2012-01-10 ...Amended: 2013-09-13 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1

/05


N Y

KIIIA 9.6.2 /06


2016 Trifloxystrobin (TFS) and metabolites: PECgw FOCUS PEARL, PELMO EUR - Use in cabbage in Europe Bayer CropScience, Report No.: EnSa-16-0095,


/10


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.2 /07




/11


N Y

KIIIA 9.6.2 /08




/12


N Y

KIIIA 9.6.2 /09





/09


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.7 /01

Kley, C.; Alt, F.

2013 Fluopyram (FLU): PECsw,sed FOCUS EUR - Use in vegetables, leafy in Europe Bayer CropScience, Report No.: EnSa-13-0929,

Edition Number: M-476041-01-1 Date: 2013-11-20 GLP/GEP: no, unpublished


N Y

KIIIA 9.7 /02

Kley, C.; Alt, F.

2013 Fluopyram (FLU): PECsw,sed FOCUS EUR - Use in leafy vegetables in Europe Bayer CropScience, Report No.: EnSa-13-0868,



N Y

KIIIA 9.7 /03

Kley, C.; Alt, F.

2013 Fluopyram (FLU): PECsw,sed FOCUS EUR - Use in field beans and strawberries in Europe Bayer CropScience, Report No.: EnSa-13-1036,



N Y

KIIIA 9.7 /04


2014 Fluopyram (FLU): PECsw,sed FOCUS EUR - Use in vines, soft fruits, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-14-1087,



N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.7 /05

Kley, C. 2013 Fluopyram Core PECsw FOCUS EU + NL: Modelling core info for surface water exposure risk assessment in European countries including the Netherlands - Fluopyram (AE C656948, FLU) Bayer CropScience, Report No.: EnSa-13-0445,



N Y

KIIIA 9.7 /06

Reinken, G.; Alt, F.

2015 Trifloxystrobin (TFS) and metabolites: PECsw,sed FOCUS EUR - Use in leafy vegetables in Europe Bayer CropScience, Report No.: EnSa-15-0327,


Date: 2015-04-23 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /01


N Y

KIIIA 9.7 /07


2015 Trifloxystrobin (TFS) and metabolites: PECsw,sed FOCUS EUR - Use in berries, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-15-0326,



N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.7 /08


2015 Trifloxystrobin (TFS) and metabolites: PECsw,sed FOCUS EUR - Use in field beans and vines in Europe Bayer CropScience, Report No.: EnSa-15-0325,



N Y

KIIIA 9.7 /09


2011 Trifloxystrobin core PECsw : Modelling core info document for standard FOCUS STEP 1 and STEP 2 surface water exposure assessment in the EU Bayer CropScience, Report No.: MEF-11/639,



N Y

KIIIA 9.7 /10


2011 Trifloxystrobin core PECsw: Modelling core info document for FOCUS STEP 3 and STEP 4 surface water exposure assessment in the EU Bayer CropScience, Report No.: MEF-11/640,


Date: 2011-10-19 GLP/GEP: no, unpublished


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.8 /01


2015 Trifloxystrobin (TFS) and metabolites: PECsw,sed FOCUS EUR - Use in leafy vegetables in Europe Bayer CropScience, Report No.: EnSa-15-0327,



N Y

KIIIA 9.8 /02


2015 Trifloxystrobin (TFS) and metabolites: PECsw,sed FOCUS EUR - Use in berries, hops and tobacco in Europe Bayer CropScience, Report No.: EnSa-15-0326,



N Y

KIIIA 9.8 /03


2015 Trifloxystrobin (TFS) and metabolites: PECsw,sed FOCUS EUR - Use in field beans and vines in Europe Bayer CropScience, Report No.: EnSa-15-0325,



N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.8 /04


2011 Trifloxystrobin core PECsw : Modelling core info document for standard FOCUS STEP 1 and STEP 2 surface water exposure assessment in the EU Bayer CropScience, Report No.: MEF-11/639,



N Y

Core greenhouse

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.4 /01

Kley, C. 2013 Predicted environmental concentrations in soil (PECsoil) of fluopyram - Use in several arable crops, fruit trees and vines in Europe Bayer CropScience, Report No.: EnSa-13-0914,



N Y

KIIIA 9.4 /02





N Y

KIIIA 9.4 /03





N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.4 /04


2014 Trifloxystrobin (TFS) and metabolites: PECsoil EUR - Use in endive, lettuce and cabbage in Europe Bayer CropScience, Report No.: EnSa-14-1288,



N Y

KIIIA 9.4 /05





N Y

KIIIA 9.5 /01





N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.5 /02





N Y

KIIIA 9.5 /03


2014 Trifloxystrobin (TFS) and metabolites: PECsoil EUR - Use in endive, lettuce and cabbage in Europe Bayer CropScience, Report No.: EnSa-14-1288,



N Y

KIIIA 9.5 /04





N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.1 /01




/01


N Y

KIIIA 9.6.1 /02




/02


N Y

KIIIA 9.6.1 /03


Edition Number: M-421835-02-1 Date: 2012-01-10 ...Amended: 2013-09-13 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.2

/03


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.1 /05




/09


N Y

KIIIA 9.6.1 /06




/10


N Y

KIIIA 9.6.1 /07





/07


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.1 /08


2016 Trifloxystrobin (TFS) and metabolites: PECgw FOCUS PEARL EUR - Use in arable crops, lettuce, and herbs in greenhouses in Northern Europe Bayer CropScience, Report No.: EnSa-16-0098,


/11


N N

KIIIA 9.6.2 /01




/01


N Y

KIIIA 9.6.2 /02





/02


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.2 /03


Edition Number: M-421835-02-1 Date: 2012-01-10 ...Amended: 2013-09-13 GLP/GEP: no, unpublished ...also filed: KIIIA 9.6.1

/03


N Y

KIIIA 9.6.2 /05




/09


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.2 /06




/10


N Y

KIIIA 9.6.2 /07




/07


N Y

KIIIA 9.7 /03

Kley, C. 2013 Fluopyram Core PECsw FOCUS EU + NL: Modelling core info for surface water exposure risk assessment in European countries including the Netherlands - Fluopyram (AE C656948, FLU) Bayer CropScience, Report No.: EnSa-13-0445,


Date: 2013-09-13 GLP/GEP: no, unpublished


N Y

Part A



zones of 118


Date: July 2018

National Addendum

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.6.1 /01


2014 Fluopyram (FLU) PECgw NED: Predicted environmental concentrations in groundwater based GeoPEARL 3.3.3 - Use in fruit culture, soft fruits in the Netherlands Bayer CropScience, Report No.: EnSa-14-1143, Edition Number: M-501880-01-1 Date: 2014-10-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 9.6.2

/01


N Y

KIIIA 9.6.2 /01


2014 Fluopyram (FLU) PECgw NED: Predicted environmental concentrations in groundwater based GeoPEARL 3.3.3 - Use in fruit culture, soft fruits in the Netherlands Bayer CropScience, Report No.: EnSa-14-1143, Edition Number: M-501880-01-1 Date: 2014-10-14 GLP/GEP: yes, unpublished ...also filed: KIIIA 9.6.1

/01


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.7 /01


2013 Predicted environmental concentrations in surface water and sediment (PECsw, sed) for fluopyram (FLU) calculated with TOXSWA 1.2 - Use in several crops in the Netherlands Bayer CropScience, Report No.: EnSa-13-0938, Edition Number: M-476792-01-1 Date: 2013-12-05 GLP/GEP: no, unpublished


N Y

KIIIA 9.7 /02

Kley, C.; Weuthen, M.

2014 Predicted environmental concentrations in surface water and sediment (PECsw, sed) for fluopyram (FLU) calculated with TOXSWA 1.2 - Use in field crops, hops, soft fruits or vine in the Netherlands Bayer CropScience, Report No.: EnSa-14-1151, Edition Number: M-502410-01-1 Date: 2014-11-09 GLP/GEP: no, unpublished


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.7 /03


2015 Predicted environmental concentrations in surface water and sediment (PECsw, sed) for trifloxystrobin (TFS) and a major aquatic metabolite (CGA 321113) calculated with TOXSWA 1.2 - Use in several crops in the Netherlands Bayer CropScience, Report No.: EnSa-15-0354, Edition Number: M-519213-01-1 Date: 2015-04-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /01


N Y

KIIIA 9.7 /04


2011 Trifloxystrobin core PECsw drift: Modelling core info document for surface water risk assessment in the Netherland Bayer CropScience, Report No.: MEF-11/636, Edition Number: M-418124-01-1 Date: 2011-11-15 GLP/GEP: no, unpublished ...also filed: KIIIA 9.8 /02


N Y

Part A



zones of 118


Date: July 2018







Study relied on Y/N

KIIIA 9.8 /01


2015 Predicted environmental concentrations in surface water and sediment (PECsw, sed) for trifloxystrobin (TFS) and a major aquatic metabolite (CGA 321113) calculated with TOXSWA 1.2 - Use in several crops in the Netherlands Bayer CropScience, Report No.: EnSa-15-0354, Edition Number: M-519213-01-1 Date: 2015-04-28 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /03


N Y

KIIIA 9.8 /02


2011 Trifloxystrobin core PECsw drift: Modelling core info document for surface water risk assessment in the Netherland Bayer CropScience, Report No.: MEF-11/636, Edition Number: M-418124-01-1 Date: 2011-11-15 GLP/GEP: no, unpublished ...also filed: KIIIA 9.7 /04


N Y

Ecotoxicology

Part A



zones of 118


Date: July 2018


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




KIIIA 10.1.6 /01

2012 Acute oral toxicity of fluopyram & trifloxystrobin SC 500 (250 + 250 g/L) to Japanese quail (Coturnix japonica) (according to OECD 223) Report No.: EnSa-12-0495, Edition Number: M-442023-01-1 Date: 2012-11-19 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.1.7 /01

Dietzen, C.; Edwards, P.J.; Wolf, C.; Ludwigs, J. D.; Luttik, R.

2013 Focal species of birds in european crops for higher tier pesticide risk assessment Publisher:SETAC, Journal:Integrated Environmental Assessment and Management, Volume:9999, Pages:1-13, Year:2013, Report No.: M-497434-02-1, Edition Number: M-497434-02-1 GLP/GEP: n.a., published

No N N

KIIIA 10.1.7 /02

Giessing, B.; Wilkens, S.

2008 Generic monitoring of birds in vegetable fields in Great Britain RifCon GmbH, Hirschberg, Germany Syngenta, Report No.: R07-034, Edition Number: M-302416-01-1 Date: 2008-06-02 GLP/GEP: yes, unpublished

Yes Syngenta N Y

KIIIA 10.1.7 /03

Maund, S. J. 2008 Letter of Access for generic behavioural ecology data: Study report Syngenta Limited document NA_10088; Grouping: vegetables, post emergence (foliar stages): Generic monitoring of birds in vegetable fields in Great Britain Syngenta Crop Protection AG, Basel, Switzerland Bayer CropScience, Report No.: M-311248-01-1, Edition Number: M-311248-01-1 Date: 2008-06-30 GLP/GEP: n.a., unpublished


N Y

Part A



zones of 118


Date: July 2018






KIIIA 10.1.7 /04

Sur, R.; Ellerich, C.

2012 Statement on residue dissipation of fluopyram in treated foliage of dicotyledonous plants: kinetic evaluation Bayer CropScience, Report No.: EnSa-12-0018, Edition Number: M-426939-02-1 Date: 2012-02-29 ...Amended: 2012-05-16 GLP/GEP: no, unpublished


N Y

KIIIA 10.1.7 /05

Rossbach, A.

2013 Residue decline of fluopyram on arthropods after spray application in vines in Germany tier3 solutions GmbH, Leichlingen, Germany Bayer CropScience, Report No.: M-453376-01-1, Edition Number: M-453376-01-1 Date: 2013-05-08 GLP/GEP: yes, unpublished


N Y

KIIIA 10.1.7 /06

Moosmayer, P.

2006 Feeding ecology of the relevant insectivorous bird species in strawberry fields in Germany RifCon GmbH, Hirschberg, Germany Irvita Plant Protection, Report No.: RC06-054, Edition Number: M-342897-01-1 Date: 2006-09-21 GLP/GEP: yes, unpublished

Yes Irvita Plant Protection

N Y

KIIIA 10.1.7 /07

Ehrlich, T. 2009 Letter of access for generic behavioural ecology data - Study report R-20183 - Grouping: strawberry (foliar stages) - Author, year: Moosmayer P, 2006 Makhteshim Chemical Works Ltd., Beer-Sheva, Israel Bayer CropScience, Report No.: M-347237-01-1, Edition Number: M-347237-01-1 Date: 2009-03-09 GLP/GEP: n.a., unpublished


N Y

KIIIA 10.1.7 / 08

Wilkens, S.; Selbach, A.; Nast, K.

2009 Generic field monitoring of birds in vegetable fields in Spain RifCon GmbH, Heidelberg, Germany Syngenta Report No.: R07-199 Edition Number: M-347259-01-1 Date: 2009-03-05 GLP/GEP: Yes, unpublished

No Syngenta Y N

Part A



zones of 118


Date: July 2018






KIIIA 10.1.7 / 09

Maund, S. J. 2009 Letter of access for generic behavioural ecology data - Study report Syngenta Limited document NA_11468 - Grouping: Vegetables, post emergence (foliar stages)

No Bayer Y Y

KIIIA 10.1.7 / 10

Rossbach, A.

2017 1st revised final report amendment - Dissipation of triadimenol, prothioconazole and fluopyram on wheat seeds and seedlings in Germany tier3 solutions GmbH, Leverkusen, Germany Bayer Report No.: B13017-1 Edition Number: M-486407-03-1 Date: 2014-05-23 ... amended: 2017-05-24 GLP/GEP: Yes, unpublished

Yes Bayer Y Y

KIIIA 10.1.7 / 11

Rossbach, A.

2014 Dissipation of triadimenol and fluopyram on barley seeds in Germany tier3 solutions GmbH, Leverkusen, Germany Bayer Report No.: M-499850-01-1 Date: 2014-09-12 GLP/GEP: Yes, unpublished

Yes Bayer Y Y

KIIIA 10.2.2.1 /01

2007 Acute toxicity of fluopyram & trifloxystrobin SC 500 (250+250) G to fish (Oncorhynchus mykiss) under static conditions Report No.: EBGMP030, Edition Number: M-294350-01-2 EPA MRID No.: 47567514 Date: 2007-11-05 GLP/GEP: yes, unpublished


N Y

KIIIA 10.2.2.2 /01

Bruns, E. 2007 Acute toxicity of AE C656948 + trifloxystrobin SC 250 + 250 G to the waterflea Daphnia magna in a static laboratory test system Bayer CropScience, Report No.: EBGMP031, Edition Number: M-292365-01-2 EPA MRID No.: 47567513 Date: 2007-09-04 GLP/GEP: yes, unpublished


N Y

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KIIIA 10.2.2.3 /01

Dorgerloh, M.

2007 Pseudokirchneriella subcapitata growth inhibition test with fluopyram & trifloxystrobin SC 500 (250 + 250)G Bayer CropScience, Report No.: EBGMP032, Edition Number: M-292579-01-2 EPA MRID No.: 47567518 Date: 2007-09-10 GLP/GEP: yes, unpublished


N Y

KIIIA 10.2.2.3 /02

Dobbins, L. L.; Schutt, W. .; Martin, K. H.; Porch, J. R.

2015 Trifloxystrobin: A 96 hour toxicity test with the freshwater diatom (Navicula pelliculosa) Wildlife International, Easton, MD, USA Bayer CropScience, Report No.: US0470, Edition Number: M-516733-01-1 Date: 2015-03-04 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.2.3 /01

Heimbach, F.; Sommer, H.; Christl, H.

2002 Biological effects and fate of trifloxystrobin WG 50 in outdoor mesocosm ponds Bayer AG, Leverkusen, Germany Bayer CropScience, Report No.: HBF/BT 04, Edition Number: M-067201-01-1 Date: 2002-06-10 GLP/GEP: yes, unpublished


N Y

KIIIA 10.2.3 /02

Heimbach, F.; Nikolakis, A.

2002 Refined risk assessment on the effects of trifloxystrobin on the aquatic freshwater community Bayer AG, Bayer CropScience, Monheim, Germany Bayer CropScience, Report No.: MO-02-008087, Edition Number: M-067239-01-1 Date: 2002-06-13 GLP/GEP: n.a., unpublished


N

Y

KIIIA 10.2.3 /03

Brock, T. C. M.

2002 Assessment of the aquatic risks of the fungicide trifloxystrobin on basis of an experimental pond study and laboratory tests with aquatic species Alterra, Green World Research, Wageningen, Netherlands Bayer CropScience, Report No.: MO-02-011771, Edition Number: M-076994-01-1 Date: 2002-08-06 GLP/GEP: n.a., unpublished


N

Y

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KIIIA 10.2.5.1 / 01

1999 Prolonged toxicity test of CGA321113 (Metabolite of CGA279202) to rainbow trout (Oncorhynchus mykiss) under flow-through conditions Bayer Report No.: 983887 Edition Number: M-070819-01-1 Date: 1999-08-02 GLP/GEP: Yes, unpublished


Y Y

KIIIA 10.2.5.2 /01

2002 Effects of trifloxystrobin WG 50 on selected early life stages of fish (Oncorhynchus mykiss) in a higher-tier indoor study, simulating the fate under field conditions Report No.: DOM 21068, Edition Number: M-056670-01-1 Method Report No.: MR-053/02 Method Report No.: MR-414/01 Date: 2002-04-09 GLP/GEP: yes, unpublished


N Y

KIIIA 10.3 /01

Hartmann, K.; Ebeling, M.; Diesing, L.

2013 Trifloxystrobin - Toxicity endpoint for the wild mammal chronic / reproductive risk assessment Bayer CropScience, Report No.: EnSa-13-0869, Edition Number: M-468788-01-1 Date: 2013-11-06 GLP/GEP: n.a., unpublished


N Y

KIIIA 10.3 /02

Ebeling, M. 2013 Trifloxystrobin used as luna Sensation on strawberries in the Netherlands: Reproductive risk assessment for wild mammals Bayer CropScience Bayer CropScience, Report No.: M-471946-01-1, Edition Number: M-471946-01-1 Date: 2013-12-05 GLP/GEP: n.a., unpublished


Y Y

KIIIA 10.3.2 /01


2015 Kinetic evaluation of trifloxystrobin residues in lettuce to derive a foliar DT50 Bayer CropScience, Report No.: EnSa-15-0361, Edition Number: M-519770-01-1 Date: 2015-04-29 GLP/GEP: no, unpublished


Y

Y

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KIIIA 10.3.2 / 02


2015 Kinetic evaluation of trifloxystrobin residues in cereals to derive a foliar DT50 Bayer Report No.: EnSa-15-0374 Edition Number: M-520275-01-1 Date: 2015-05-04 GLP/GEP: No, unpublished


Y N

KIIIA 10.3.2 / 03

Tack, T. J. 1998 Winter wheat: Generation of crop samples for subsequent residue analyses following foliar treatment with CGA 279202 plus CGA 64250 (A-9525B) in Denmark Novartis Crop Protection UK Ltd., Whittlesford, United Kingdom Bayer Report No.: FR1096 Edition Number: M-053990-01-1 Date: 1998-02-03 GLP/GEP: Yes, unpublished


Y Y

KIIIA 10.3.2 / 04

Tack, T. J. 1998 Winter wheat: Generation of crop samples for subsequent residue analysis following foliar treatment with CGA 279202 plus CGA 64250 (A-9525B) in Denmark Novartis Crop Protection UK Ltd., Whittlesford, United Kingdom Bayer Report No.: FR1196 Edition Number: M-053976-01-1 Date: 1998-02-03 GLP/GEP: Yes, unpublished


Y Y

KIIIA 10.3.2 / 05

Kley, C.; Ellerich, C.

2018 Fluopyram (FLU) - Kinetic evaluation of green plant residues in cereals Bayer AG, Crop Science Division, Monheim, Germany Bayer Report No.: EnSa-17-0484 Edition Number: M-617837-01-1 Date: 2018-03-13 GLP/GEP: No, unpublished


Y Y

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Date: July 2018






KIIIA 10.3.2 / 06

Glaubitz, J.; Szeley, C.

2013 Determination of the residues of AE C656948 and prothioconazole in/on barley, spring after spray application of AE C656948 & JAU 6476 SE 250 in Germany, Belgium and the Netherlands Bayer Report No.: 13-2950 Report includes Trial Nos.:

13-2950-01 13-2950-02 13-2950-03 13.2950-04

Edition Number: M-471216-01-1 Date: 2013-11-25 GLP/GEP: Yes, unpublished


Y Y

KIIIA 10.3.2 / 07

Glaubitz, J.; Hennes, M.

2016 Determination of the residues of AE C656948 and prothioconazole in/on wheat after spray application of AE C656948 & JAU 6476 SE 250 in the Netherlands, Belgium, Italy and Spain Bayer Report No.: 15-2952 Report includes Trial Nos.:

15-2952-01 15-2952-02 15-2952-03 15-2952-04



Y Y

KIIIA 10.3.2 / 08

Glaubitz, J.; Hennes, M.

2016 Determination of the residues of AE C656948 and trifloxystrobin in/on wheat after spray application of AE C656948 & CGA279202 SC 500 in the field in northern France, United Kingdom, Italy and Greece Bayer Report No.: 15-2953 Report includes Trial Nos.:

15-2953-01 15-2953-02 15-2953-03 15-2953-04



Y Y

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Date: July 2018






KIIIA 10.3.2.1 /01

Schuengel, M.

2007 AE C656948 & trifloxystrobin SC 250 & 250 - Acute toxicity in the rat after oral administration Bayer HealthCare AG, Wuppertal, Germany Bayer CropScience, Report No.: AT03692, Edition Number: M-287410-01-2 EPA MRID No.: 47567529 Date: 2007-03-01 GLP/GEP: yes, unpublished ...also filed: KIIIA 7.1.1 /01


N Y

KIIIA 10.3.3 /01

Barfknecht, R.

2013 Voles in fields with leafy vegetables Bayer CropScience, Report No.: BAR/FS065, Edition Number: M-449690-01-1 Date: 2013-03-15 GLP/GEP: yes, unpublished


N Y

KIIIA 10.3.3 /02

Jacob, J.; Manson, P.; Barfknecht, R.; Fredricks, T.

2013 Common vole (Microtus arvalis) ecology and management: implications for risk assessment of plant protection products Publisher:(wileyonlinelibrary.com) DOI 10.1002/ps.3695, Journal:Society of Chemical Industry, Pest Manag Sci, Year:2014, Report No.: M-476622-01-1, Edition Number: M-476622-01-1 GLP/GEP: n.a., published

No N Y

KIIIA 10.3.3 /03

Wang, M. 2014 Population modeling · Use of scenarios to avoid different levels of protection Journal:WSC Regexperts, Year:2014, Report No.: M-489393-01-1, Edition Number: M-489393-01-1 GLP/GEP: n.a., published

No N Y

KIIIA 10.3.3 /04

Lauenstein, G.

1979 Zur Problematik der Bekaempfung von Feldmaeusen (Microtus arvalis (Pall.)) auf Gruenland Journal:Zeitschrift fuer angewandte Zoologie, Volume:66, Pages:35-59, Year:1979, Report No.: MO-03-011954, Edition Number: M-115867-01-1 GLP/GEP: n.a., published

No N Y

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KIIIA 10.4.2.1 /01

Schmitzer, S.

2007 Effects of AE C656948+trifloxystrobin SC 250+250 g/L (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory IBACON GmbH, Rossdorf, Germany Bayer CropScience, Report No.: 34491035, Edition Number: M-288193-01-2 EPA MRID No.: 47567515 Date: 2007-05-21 GLP/GEP: yes, unpublished


N Y

KIIIA 10.5.1 /01

Roehlig, U. 2007 Dose-response toxicity (LR50) of AE C656948 & trifloxystrobin SC 250 + 250 g/L to the predatory mite Typhlodromus pyri (Scheuten) under laboratory conditions BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 06 10 48 190, Edition Number: M-283552-01-1 Date: 2007-01-30 GLP/GEP: yes, unpublished


N Y

KIIIA 10.5.1 /02

Roehlig, U. 2007 Dose-response toxicity (LR50) of AE C656948 & trifloxystrobin SC 250 + 250 g/L to the parasitic wasp Aphidius rhopalosiphi (Destefani-Perez) under laboratory conditions BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 06 10 48 189, Edition Number: M-283599-01-1 Date: 2007-01-30 GLP/GEP: yes, unpublished


N Y

KIIIA 10.5.2 /01

Barth, M. 2007 Dose-response toxicity of AE C656948 & Trifloxystrobin SC 250 + 250 to the predatory bug Orius laevigatus (FIEBER) (Heteroptera: Anthocoridae) under extended laboratory conditions BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 07 10 48 049 A, Edition Number: M-297476-01-1 Date: 2007-12-18 GLP/GEP: yes, unpublished


N Y

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KIIIA 10.5.2 /02

Barth, M. 2008 Toxicity of AE C656948 & Trifloxystrobin SC 250 + 250 to the predatory bug Orius laevigatus (FIEBER) (Heteroptera: Anthocoridae) under extended laboratory conditions using semi-field-aged residues on grape-vine BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 07 10 48 005 A, Edition Number: M-297471-01-1 Date: 2008-01-30 GLP/GEP: yes, unpublished


N Y

KIIIA 10.5.2 /03

Roehlig, U. 2014 Effects of fluopyram + trifloxystrobin SC 500 (250+250 g/L) on the green lacewing Chrysoperla carnea (STEPH.) under extended laboratory conditions BioChem agrar GmbH, Gerichshain, Germany Bayer CropScience, Report No.: 14 10 48 022 A, Edition Number: M-482453-01-1 Date: 2014-03-25 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.6.2 /01

Leicher, T. 2007 AE C656948 & trifloxystrobin SC 250 & 250: acute toxicity to earthworms (Eisenia fetida) tested in artificial soil with 5 percent peat Bayer CropScience, Report No.: LRT/RG-A-77/06, Edition Number: M-284363-01-1 Date: 2007-02-27 GLP/GEP: yes, unpublished


N Y

KIIIA 10.6.2 /02

Leicher, T. 2007 AE C656948 SC 500: acute toxicity to earthworms (Eisenia fetida) tested in artificial soil with 5 percent peat Bayer CropScience, Report No.: LRT/RG-A-78/06, Edition Number: M-284362-01-1 Date: 2007-02-27 GLP/GEP: yes, unpublished


N N

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KIIIA 10.6.3 /01

Leicher, T. 2007 AE C656948 & trifloxystrobin SC 250 & 250 G: effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artificial soil with 5 percent peat Bayer CropScience, Report No.: LRT-RG-R-28/06, Edition Number: M-283637-01-1 Date: 2007-02-15 GLP/GEP: yes, unpublished


N Y

KIIIA 10.6.3 / 02

Leicher, T. 2009 Trifloxystrobin (technical): Effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artificial soil with 5 % peat


Y Y

KIIIA 10.6.5 /01

Egeler, Ph.; Gilberg, D.

2009 Fluopyram: A study on the bioaccumulation by the earthworm Eisenia fetida ECT Oekotoxikologie GmbH, Floersheim, Germany Bayer CropScience, Report No.: 08P1RD, Edition Number: M-349703-01-1 Date: 2009-06-19 GLP/GEP: yes, unpublished


N Y

KIIIA 10.6.5 /02

Bongartz, R. 2009 Fluopyram: A study on the bioaccumulation by the earthworm - Metabolism investigations Bayer CropScience, Report No.: MEF-09/113, Edition Number: M-343213-01-1 Date: 2009-03-05 GLP/GEP: yes, unpublished


N Y

KIIIA 10.6.5 /03

Stupp, H. P. 2009 [Phenyl-UL-14C]AE C656948 (fluopyram): Determination of residues in soil samples from ETX study ECT 08P1RD Bayer CropScience, Report No.: MEF-09/153, Edition Number: M-345856-01-1 Date: 2009-04-15 GLP/GEP: yes, unpublished


N Y

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KIIIA 10.6.6 /01

Larnaudie Lopez, M. I.

2016 Fluopyram + trifloxystrobin SC 500 (250+250) G: Influence on mortality and reproduction of the soil mite species Hypoaspis aculeifer tested in artificial soil Bayer CropScience, Report No.: E 428 4844-4, Edition Number: M-548820-01-1 Date: 2016-02-25 GLP/GEP: yes, unpublished


Y Y

KIIIA 10.7.1 /01

Leicher, T. 2007 Fluopyram + trifloxystrobin SC 500 (250+250) G : Determination of effects on carbon transformation in soil Bayer CropScience, Report No.: LRT-C-80/07, Edition Number: M-294811-01-1 Date: 2007-11-20 GLP/GEP: yes, unpublished


N Y

KIIIA 10.7.1 /02

Leicher, T. 2007 Fluopyram + trifloxystrobin SC 500 (250+250) G: Determination of effects on nitrogen transformation in soil Bayer CropScience, Report No.: LRT-N-91/07, Edition Number: M-295282-01-1 Date: 2007-12-04 GLP/GEP: yes, unpublished


N Y

KIIIA 10.8.1.2 /01

Gosch, H.; Nguyen, D. H.

2007 Non-target terrestrial plants: an evaluation of the effects of AE C656948 + Trifloxystrobin SC 250 + 250 g/L in the vegetative vigour test (Tier 1) Bayer CropScience, Report No.: VV07/03, Edition Number: M-289527-01-1 Date: 2007-06-28 GLP/GEP: no, unpublished


N Y

KIIIA 10.8.1.2 /02

Koehler, P. 2013 Fluopyram + trifloxystrobin SC 500 (250 + 250 g/L) - Effects on the vegetative vigour of ten species of non-target terrestrial plants (Tier 1) Bayer CropScience, Report No.: VV13/033, Edition Number: M-464310-01-1 Date: 2013-09-11 GLP/GEP: yes, unpublished


Y Y

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KIIIA 10.8.1.3 /01

Gosch, H.; Nguyen, D. H.

2007 Non-target terrestrial plants: an evaluation of the effects of AE C656948 + trifloxystrobin SC 250 + 250 g/L in the seedling emergence and growth test (Tier 1) Bayer CropScience, Report No.: SE07/03, Edition Number: M-289525-01-1 Date: 2007-06-28 GLP/GEP: no, unpublished


N Y

KIIIA 10.1.7 /01

Ebeling, M. 2015 FLU + TFS SC 500: Justification for not conducting a quantitative higher tier risk assessment for granivorous birds in lettuce fields Bayer CropScience, Report No.: M-518078-01-1, Edition Number: M-518078-01-1 Date: 2015-04-24 GLP/GEP: n.a., unpublished


N Y

KIIIA 10.3.1.3 /01

Ebeling, M. 2015 Luna Sensation, FLU + TFS SC 500: Justification for dose level selection in BMD calculation for trifloxystrobin Report No.: M-518195-01-1, Edition Number: M-518195-01-1 Date: 2015-04-30 GLP/GEP: n.a., unpublished

No N Y

KIIIA 10.10 /01

Suteau, P; Guckenmus, B.

2014 Fluopyram + trifloxystrobin SC 500 (250 + 250 g/L) - Combined toxicity risk for the Netherlands Bayer CropScience, Report No.: M-505600-01-1, Edition Number: M-505600-01-1 Date: 2014-12-08 GLP/GEP: n.a., unpublished


N Y

Efficacy No data relied on

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Date: July 2018

HET COLLEGE VOOR DE TOELATING VAN ......14437 N Luna Sensation, 20146203 ZWTG HET COLLEGE VOOR DE...

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